https://biospectrumindia.com/rssfeed/pharma/bioservices bioservices https://biospectrumindia.com/news/97/28629/cutyx-research-and-biota-announce-strategic-oral-film-strip-collaboration.html https://biospectrumindia.com/news/97/28629/cutyx-research-and-biota-announce-strategic-oral-film-strip-collaboration.html Sun, 11 Oct 2026 14:36:58 +0530 Cutyx Research LLP, an India-based contract research and formulation development organisation, and Biota, an Israel-based biotechnology company, have announced a strategic collaboration and technology license agreement to jointly develop and commercialise oral film strip formulations built on Biota’ s proprietary platform technology, which is patent-protected in India and other territories. Under the agreement, Biota will license its platform technology to Cutyx, which will lead formulation design, feasibility studies, and prototype development for a pipeline of active pharmaceutical ingredients. Oral film strips offer a fast-dissolving, water-free alternative to conventional tablets and capsules — a format particularly well suited to pediatric, geriatric, and dysphagia patient populations. The companies will pursue commercialisation jointly through partnering, licensing, and technology transfer arrangements with pharmaceutical and CDMO organizations worldwide. ]]> https://biospectrumindia.com/news/97/28612/piramal-pharma-solutions-launches-new-microbiology-laboratory-at-lexington-sterile-injectable-facility.html https://biospectrumindia.com/news/97/28612/piramal-pharma-solutions-launches-new-microbiology-laboratory-at-lexington-sterile-injectable-facility.html Wed, 07 Oct 2026 18:57:06 +0530 Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organisation (CDMO) and part of Piramal Pharma, has opened a new microbiology laboratory at its sterile injectable facility in Lexington, Kentucky, US. This addition marks a significant step forward in PPS' ongoing $85 million Lexington expansion, aimed at enhancing commercial-scale capabilities and improving operational efficiency. The new laboratory was released for routine GMP use on September 11, 2026, and shortly thereafter, its new sterility testing suite was conditionally approved, making the lab one of the first major components to come online in the expansion. The full manufacturing expansion is expected to be operational in late 2027. The new lab more than triples the site's existing microbiology testing space, supporting improved laboratory workflow and providing additional capacity to accommodate future growth. The added space features three new biosafety cabinets, allowing PPS to run concurrent tests and reduce sample queue times. All incubators have also been consolidated within the new lab, further streamlining workflow and improving monitoring and accessibility across testing activities. ]]> https://biospectrumindia.com/news/97/28580/shilpa-biologicals-unveils-new-gene-to-gmp-manufacturing-platform-sb-himax-for-biotechs-.html https://biospectrumindia.com/news/97/28580/shilpa-biologicals-unveils-new-gene-to-gmp-manufacturing-platform-sb-himax-for-biotechs-.html Wed, 30 Sep 2026 17:45:53 +0530 Shilpa Biologicals, a subsidiary of Shilpa Medicare, has launched its new gene to GMP manufacturing platform, SB HiMax which will empower biotechs to take suitable monoclonal-antibody programmes from gene to GMP clinical supply in as little as nine months, and complex bispecific and trispecific antibodies in approximately 11 months.   The new service – being launched at CPHI Milan, 6–8 October 2026 – has been specifically created for biotechs seeking accelerated development timelines but struggling to find partners able to offer the necessary speed and flexibility.   Unlike conventional cell-line development platforms, SB HiMax provides an integrated pathway from clone development and cell-bank creation through upstream and downstream process development, analytical-method development, GMP drug-substance manufacturing and drug-product filling.   CMC development and regulatory support are embedded throughout, enabling customers to progress towards clinical studies without repeatedly transferring their programme between different providers.   Significantly, SB HiMax, not only helps clients improve timelines but also improves yield, with the platform typically achieving >5 g/L, which is significantly above the industry average for 1–3 g/L for CHO fed-batch processes.  The service is available not just across monoclonal targets but is available to customers with ADCs, bioconjugates, microbial-expressed products and recombinant proteins.   SB HiMax accelerates development by running clone screening, process development and key CMC activities in parallel, supported by established platform processes and single-use GMP manufacturing. The platform scales to 2,000 L while maintaining critical quality attributes and less than 10% titre variation, helping customers establish a commercially viable process from the outset. ]]> https://biospectrumindia.com/news/97/28567/akums-receives-dcgi-approval-for-colchicine-0-5-mg-tablets-expanding-preventive-cardiology-portfolio.html https://biospectrumindia.com/news/97/28567/akums-receives-dcgi-approval-for-colchicine-0-5-mg-tablets-expanding-preventive-cardiology-portfolio.html Tue, 29 Sep 2026 14:49:06 +0530 Delhi-based Akums Drugs & Pharmaceuticals, a Contract Development and Manufacturing Organization (CDMO), has received DCGI approval for Colchicine 0.5 mg Tablets, marking a significant addition to its cardiovascular and preventive cardiology portfolio. The approval represents a first-time-in-India regulatory milestone for this application and reinforces Akums’ focus on differentiated therapies addressing evolving healthcare needs.The approval comes at a time when India’s pharmaceutical market continues to witness strong growth, particularly across chronic therapies. According to Pharmarack, the Indian Pharmaceutical Market (IPM) grew 10.7% year-on-year in August 2026 to Rs 23,272 crore. Chronic therapies continued to be an important growth driver, reflecting the increasing demand associated with long-term disease management. The cardiac segment has emerged as one of the key contributors to this growth. In July 2026, the cardiac therapy market recorded 14.7% year-on-year growth and sales of approximately Rs 3,299 crore, according to Pharmarack.Colchicine is a well-established anti-inflammatory agent that works through mechanisms including inhibition of microtubule polymerisation and modulation of inflammatory signalling pathways. Akums’ approved 0.5 mg formulation is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularisation and cardiovascular death in adult patients with established atherosclerotic disease or multiple cardiovascular risk factors.The product information identifies mechanisms including inhibition of NLRP3 inflammasome activation, reduction of neutrophil activation and migration, and suppression of endothelial inflammation—pathways associated with vascular inflammation and atherosclerotic plaque vulnerability. ]]> https://biospectrumindia.com/news/97/28568/biodeal-pharma-expands-into-sterile-injectables-with-acquisition-of-biological-e-facility.html https://biospectrumindia.com/news/97/28568/biodeal-pharma-expands-into-sterile-injectables-with-acquisition-of-biological-e-facility.html Tue, 29 Sep 2026 14:56:59 +0530 Biodeal Pharmaceuticals, a leading Contract Development and Manufacturing Organisation (CDMO), has acquired a sterile injectable manufacturing facility in Paonta Sahib, Himachal Pradesh – one of the largest manufacturing facilities in the state – from Biological E Limited. The acquisition marks a strategic expansion of Biodeal's manufacturing platform into sterile injectables for global markets, adding established regulatory credentials, specialised capabilities and significant manufacturing capacity to its portfolio. The facility is equipped for general injectables and Carbapenem manufacturing in vial formats, supported by German-made Groninger processing lines, with current annual capacity of around 135 million units. There is scope to expand to the facility's full capacity of 17 production lines and to add pre-filled syringe (PFS) and lyophilised formats. Biodeal is pursuing PIC/S and EU accreditation for the facility as part of its plans to expand into additional regulated markets. Spread across a 14-acre campus, the Paonta Sahib facility comprises approximately 39,000 square metres of built-up manufacturing space and has the potential to add a further capacity of 30 million units through near-term expansion. Located approximately 50 kilometres from Biodeal’s existing Nalagarh facility, the acquisition also strengthens the company’s manufacturing footprint within Himachal Pradesh’s established pharmaceutical corridor. The facility was acquired from Biological E Limited, a Hyderabad-headquartered vaccine and pharmaceutical manufacturer with nearly seven decades of operations, as part of Biological E's ongoing investment in its new vaccine R&D and CDMO campus in Telangana. With this acquisition, Biodeal adds established manufacturing capacity and credentials to its platform, broadening the range of complex injectable manufacturing it can offer pharmaceutical customers globally - spanning Carbapenems for serious bacterial and drug-resistant infections, and in process of expanding into ready-to-use pre-filled syringe formats, and lyophilised products with extended stability and shelf life. ]]> https://biospectrumindia.com/news/97/28512/akums-announces-launch-of-dcgi-approved-triple-therapy-for-h-pylori-infection.html https://biospectrumindia.com/news/97/28512/akums-announces-launch-of-dcgi-approved-triple-therapy-for-h-pylori-infection.html Mon, 21 Sep 2026 13:20:41 +0530 Delhi-based Akums Drugs & Pharmaceuticals has announced the development of a DCGI-approved Clarithromycin + Vonoprazan + Amoxicillin Combikit for the treatment of Helicobacter pylori (H. pylori) infection in adults. The development is part of the company's ongoing work in pharmaceutical formulation and reflects the growing focus within healthcare on treatment approaches that consider both therapeutic requirements and the practical aspects of completing a prescribed regimen. H. pylori infection is associated with chronic gastritis and peptic ulcer disease and is recognised as an important risk factor for gastric cancer. Effective eradication of the infection is therefore an important therapeutic objective and can help reduce infection-related complications. The combikit combines Vonoprazan, a potassium-competitive acid blocker (P-CAB), with Clarithromycin and Amoxicillin. Vonoprazan provides sustained suppression of gastric acid secretion, while the two antibiotics provide complementary antibacterial action against H. pylori. The prescribed regimen involves twice-daily dosing over a period of 14 days. The formulation brings the three components together in an organised treatment pack containing Clarithromycin 500 mg, Vonoprazan 20 mg and Amoxicillin 1000 mg. The formulation also provides the full 1000 mg dose of Amoxicillin in one tablet. The announcement comes at a time when the pharmaceutical industry is placing greater emphasis on patient-centred approaches to healthcare. In combination therapies, the organisation and administration of treatment can be an important consideration alongside the therapeutic properties of individual medicines. ]]> https://biospectrumindia.com/news/97/28485/neuland-accelerates-peptide-manufacturing-expansion-to-meet-rising-customer-demand.html https://biospectrumindia.com/news/97/28485/neuland-accelerates-peptide-manufacturing-expansion-to-meet-rising-customer-demand.html Tue, 15 Sep 2026 16:38:03 +0530 Hyderabad-based Neuland Laboratories is accelerating its peptide manufacturing expansion, as the first of four scheduled modules has commenced operations at its commercial peptide manufacturing site.  Significantly, with foundational infrastructure for the second module already in place, Neuland expects to begin work ahead of the original timeline once customer requirements are finalised — configuration, instrumentation and capacity are currently being defined in close collaboration with the customer whose projects will anchor the expanded capability. The newly operational module one provides 7000L total reactor capacity, 750L of solid-phase peptide synthesis (SPPS) and 6250L liquid-phase peptide synthesis (LPPS). This enables flexible customer programmes from small‑scale to multikilogram quantities for complete peptide APIs – including complex and long‑chain peptides – as well as commercial scale production of crude peptides. Additionally, the SPPS and LPPS reactors are housed in different suites enabling parallel operation and are supported by three Dynamic Axial Compression (DAC) columns [one 45 cm and two 60 cm] and two lyophilisers with 100 L and 200 L capacities.   Following the $30 million investment in module one, Neuland is aligning further investment for subsequent modules with new customer requirements. Module two is planned to provide an overall reactor capacity of up to 18,000 L, comprising three 5,000 L LPPS reactors, as well as either a 1,000 L or 2,000 L SPPS reactor, and smaller reactors of up to the 1,000 L scale. This flexible configuration will allow Neuland to support a broad range of peptide programmes and production scales. The range of partner indications is also broadening beyond obesity and metabolic disease, with oncology emerging as a particularly active area of early-stage development. As peptide pipelines expand, a growing number of biotech companies are struggling to access capable outsourced development and commercial manufacturing capacity. Module one is supported by a team of nearly 212 peptide experts and this latest news follows on from an impressive few years for the CDMO. Revenues rose by a massive 116.3% in its most recent quarterly results, driven chiefly by increased commercial contracts, as well as a growing number of clinical projects.  ]]> https://biospectrumindia.com/news/97/28447/complex-molecule-specialist-shilpa-cdmo-launches-at-cphi-milan.html https://biospectrumindia.com/news/97/28447/complex-molecule-specialist-shilpa-cdmo-launches-at-cphi-milan.html Wed, 09 Sep 2026 22:07:15 +0530 Shilpa CDMO (customer-facing brand of Shilpa Pharma Lifesciences), a dedicated complex small-molecule contract development and manufacturing organisation will launch next month at CPHI Milan 2026 (6–8 October, Fiera Milano).  The new brand, separate from parent company Shilpa Medicare, provides  a specialist development and commercial manufacturing partner for biotech and pharma customers with complex small molecules, building on Shilpa’s more than 30 years of oncology expertise. Keshav Bhutada, Chief Executive Officer of Shilpa CDMO, said, “We have long been known among our existing partners as incredibly capable, particularly for challenging molecules such as HPAPIs and peptides, and more recently ADC payloads and linkers, PROTACs and oligonucleotides. However, with the growth and opportunity we are now seeing in the CDMO division, it became clear that we needed a much stronger and more distinct business that shows a broader range of innovators our extensive contract service capabilities for novel and complex molecules. Shilpa Pharma’s CDMO division will therefore now go to market as Shilpa CDMO and is dedicated to complex molecule development. Essentially, we love working on our partners’ most challenging projects.” The launch comes as US and European biotechnology companies increasingly seek to diversify their development and manufacturing strategies beyond China. Yet while the global CDMO market contains hundreds of providers, the expertise and infrastructure required to advance genuinely complex molecules remain concentrated among a relatively small number of organisations – many of which have limited near-term availability, are China-centric or naturally prioritise their largest customers. To meet the rising demand, Shilpa CDMO is continuing to invest in what is already one of India’s largest small-molecule development and manufacturing platforms. Its infrastructure includes 230 kL of reactor capacity, three R&D centres, more than 400 scientists and two dedicated API manufacturing sites. In addition to significant commercial infrastructure, the new CDMO brings together dedicated R&D teams for HPAPIs and oncology, peptides, ADC payloads and linkers, oligonucleotides and PROTACs. Its integrated capabilities extend from discovery and route scouting through process and analytical development to commercial drug-substance and finished-dose manufacturing.   ]]> https://biospectrumindia.com/news/97/28425/cohance-lifesciences-commits-18-m-across-nj-bio-and-aruka-bio-to-expand-adc-capabilities.html https://biospectrumindia.com/news/97/28425/cohance-lifesciences-commits-18-m-across-nj-bio-and-aruka-bio-to-expand-adc-capabilities.html Thu, 03 Sep 2026 22:12:56 +0530 Hyderabad-based Cohance Lifesciences has announced a strategic investment of $18 million- in NJ Bio ($13 million) and Aruka Bio ($5 million) to strengthen its Antibody-drug Conjugate (ADC) platform and expand its global CRDMO capabilities. Both the transactions will be funded through internal accruals.The re-organisation establishes distinct priorities: deeper integration of NJ Bio’s customer-facing services with Cohance, and focused development of Aruka’s proprietary pipeline through potential partnerships. Cohance will increase its common-equity ownership in NJ Bio from 56% to 67.3%, acquiring the entire holdings of Priyashri Nayak, and the Jain Family Irrevocable Trust. Dr Naresh Jain will retain 32.7%.    On the other hand, Aruka Bio, Inc. is a private biotechnology company based in Princeton, New Jersey, focused on developing next-generation antibody-drug conjugates. Its lead programme is currently at the preclinical stage. Cohance’s $5 million equity investment will fund the buyout of other existing shareholders and convertible noteholders along with working capital. Following completion and Dr Jain’s upfront equity grant, Aruka will be owned 65% directly by Cohance, 25% by NJ Bio and 10% by Dr Jain.  Aruka will become Cohance’s direct subsidiary. The investment consolidates control of Aruka’s proprietary ADC platform, positioning it to pursue co-development, licensing and other collaborations with pharmaceutical and biotechnology partners as its pipeline progresses.   ]]> https://biospectrumindia.com/views/97/28391/pharma-manufacturing-is-data-rich-and-decision-poor.html https://biospectrumindia.com/views/97/28391/pharma-manufacturing-is-data-rich-and-decision-poor.html Tue, 01 Sep 2026 10:17:33 +0530 Pivot Path recently secured an investment of Rs 100 crore from Ascent Capital. What are your strategic priorities for deploying this capital, and how will it support the company's next phase of growth? The investment is concentrated where the regulated workload is heaviest and the manual effort least defensible. In pharmacovigilance, that is NovaVigil: extraction, data entry etc. consume qualified people on work that does not need their judgement. In quality and compliance, it is NoteIQ, because validation and controlled documents are where a change gets stuck for months. AnomIQ, because audit-trail review is done at defined intervals by sampling, rather than through continuous real-time monitoring.  Issues may remain undetected for extended periods, limiting the ability to take prompt corrective or remedial actions on batches. InvestigationIQ, because root-cause analysis is done by scarce specialists who spend most of their time on method and formatting rather than on reasoning. Each of these platforms runs on the same validated foundation, which is what makes every new platform more efficient than the one before it. The second priority is proximity to the regulators our clients answer to. Their obligations sit with the FDA, EMA, MHRA and TGA, and clients want people who understand those regimes in the same time zone as the affiliate carrying them. We are building client-facing leadership in Europe, with leads based in Prague and in Switzerland, and delivery from Bengaluru, Romania, Hyderabad and Mysuru. The third is depth of domain talent, which for us means people who have worked inside pharma rather than people who have worked on pharma projects. It is the slowest thing to build and the first thing a client notices. Pivot Path serves more than 70 pharma companies across five continents. Could you share details about some of your key clients in India and globally, and the nature of your engagements with them? At Indian CDMO, the business doubled year on year. We advised on and automated 50+ IT processes, absorbing 2x growth without them having to add headcount. After acquiring a plant in Europe, a global client faced a strict seller deadline. We were able to carve out and transition their entire IT, SAP and quality infrastructure setup in just 60 days, ensuring continued operations and no downtime. In Singapore, we digitised a client’s entire validation system and went live in two and a half months, achieving error-free compliance. Buoyed by this success, we are doing the same for a large Indian generics brand, as we speak. A deep multi-modal engagement we can talk about, was with an Indian bio-similar manufacturer. We entered the project with a 200-day launch window, and were able to build the enterprise IT setup, executed system validation and 200 personnels to staff it.   Most clients engage with us on more than one of the three things we do. Consulting is a decision or a remediation: an inspection response, a validation strategy. Operations are running a function to a service level: pharmacovigilance case processing, validation execution, IT across a manufacturing network. Technology is implementing the enterprise applications a company runs on or deploying our own platforms. All three are contracted separately, which matters, because a client can start with one and add the others without renegotiating the relationship. How has the pharmaceutical technology landscape evolved over the years, and what are the key trends shaping the industry today? For two decades, pharma technology was built around inspections. The industry became very good at proving what it had done and very poor at using the same information to make better decisions. Three things changed in recent years: The first is access. A capability that once required a dedicated research team is now accessible to every organisation. Whether you could build it stopped being the constraint. The second is that AI crossed from pilots into production. Every pharma AI project used to stall as a proof of concept, because nobody could explain to an inspector how an output had been produced. That is now solvable: retrieval that cites its sources rather than guessing, outputs that are versioned, traceable and re-runnable, and a knowledge graph underneath holding the context an answer depends on. The third, and the least discussed, is that the regulators have matured. GAMP 5 addresses AI and machine learning directly, the EU AI Act sets out expectations and inspectors increasingly arrive with questions rather than objections. You can now validate an AI system instead of avoiding one. India is witnessing a surge in pharmaceutical GCCs. What factors are driving this growth? What are the biggest digital transformation priorities for pharma GCCs today? We are a product of this trend, which gives me a more direct view than most. Pivot Path is the demerged entity of Arcolab, built as the global capability centre for a pharmaceutical group with a 35-year history, and now an independent company. The arc from cost centre to capability centre to a business with its own products is the arc this question is about, and we have walked it. Only one of the three drivers is cost. Talent depth is first: three decades as the pharmacy of the world has left India with people who have run regulated operations rather than read about them. Second, the mandate moved. A centre that began with transaction processing now runs pharmacovigilance for a global portfolio, owns validation across a site network and builds software. Third, cloud, data and AI talent now sit in the same cities as pharma talent, which was not true ten years ago. Proving to the parent that work done here can carry regulatory accountability, not merely execute against it. And holding quality while headcount doubles, in a market where the best people now have better options than they did five years ago. Looking ahead, which emerging technologies have the greatest impact on the pharmaceutical industry over the next five to ten years? Digital twins with predictive analytics in manufacturing because that is where the industry still leaves the most value on the floor. Pharma manufacturing is data-rich and decision-poor. Batch records, process parameters and equipment telemetry all exist in volume, and almost all of it is used retrospectively to demonstrate a batch was acceptable, rather than to steer it while it is still running. The second is immersive technology, where we work with a partner, 8Chili. VR is for training; we convert SOPs and machine operations into digital twins, so an operator is trained and certified on a line before going near it. AR is for execution. The SOP instruction arrives in the operator's field of view at the moment of the task; the operator performs it, and evidence is captured as it happens rather than written up afterwards, with the checker verifying through the same channel. That is human-in-the-loop in the most literal sense, and in an industry where deviations often trace back to human factors, it is a compliance investment rather than an HR one. Autonomous manufacturing sits further out for regulated products, correctly so. What arrives first is autonomy inside bounded loops, with a qualified person holding the release decision.   Sanjiv Das sanjiv.das@mmactiv.com ]]> https://biospectrumindia.com/news/97/28393/aragen-life-sciences-files-drhp-with-sebi-for-ipo.html https://biospectrumindia.com/news/97/28393/aragen-life-sciences-files-drhp-with-sebi-for-ipo.html Thu, 27 Aug 2026 20:57:50 +0530 Aragen Life Sciences, a leading contract research, development and manufacturing organisation (CRDMO), has filed its draft red herring prospectus (DRHP) with SEBI for an initial public offering (IPO). The IPO comprises a fresh issue of Rs 800 crore and an offer for sale (OFS) aggregating up to 27,329,192 equity shares of face value of Rs 10 each by selling shareholders. The proceeds from the fresh issue are proposed to be utilised towards the repayment and/or pre-payment of borrowings; capital expenditure to be incurred by the company for purchase of new equipment and machinery for the company’s facilities in Hyderabad; capital expenditure to be incurred by one of the company’s material subsidiaries, Aragen Biologics Private Limited, for the facility in Bengaluru, towards purchase of new equipment and machinery; and general corporate purpose, supporting the company's next phase of expansion. The company has become one of the top three largest Indian CRDMOs in terms of operating revenue among the assessed Indian peers, operating in a global CRDMO market estimated at $171 billion in Fiscal 2026. ]]> https://biospectrumindia.com/news/97/28380/aurigene-announces-manufacturing-and-supply-partnership-with-global-pharma-company.html https://biospectrumindia.com/news/97/28380/aurigene-announces-manufacturing-and-supply-partnership-with-global-pharma-company.html Wed, 26 Aug 2026 14:56:15 +0530 Hyderabad-based Aurigene Pharmaceutical Services, a wholly owned subsidiary of Dr. Reddy's Laboratories, has announced a strategic, long-term Manufacturing and Supply Agreement (MSA) with a leading global pharmaceutical company for the commercial drug-product manufacturing and supply of a diversified portfolio for USA, Europe, Canada and Emerging markets. The agreement establishes a full-service framework for technical transfer, process development, scale-up, validation, commercial manufacturing and long-term supply. The collaboration highlights Aurigene’s expanding drug product CDMO (Contract Development and Manufacturing Organization) and CMO (Contract Manufacturing Organization) capabilities, particularly in sterile injectables and biologics, complementing its established development and manufacturing expertise across the pharmaceutical value chain. The initial portfolio comprises 20+ products spanning sterile injectables, biologics and topicals, to be manufactured across facilities in India. The partnership is expected to progress through a phased technology transfer programme over the next two to three years, paving the way for commercial manufacturing and supply. At full commercialisation, the portfolio is expected to represent an estimated annual volume of approx.18 million units, largely being injectables, with revenues expected to commence from the calendar year 2028. ]]> https://biospectrumindia.com/news/97/28369/bioforum-the-data-masters-expands-global-footprint-with-new-office-and-gcc-in-bengaluru.html https://biospectrumindia.com/news/97/28369/bioforum-the-data-masters-expands-global-footprint-with-new-office-and-gcc-in-bengaluru.html Tue, 25 Aug 2026 15:06:12 +0530 Bioforum The Data Masters, a global biometric CRO supporting clinical development through data management, biostatistics, statistical programming, medical writing, and project management for clinical trial sponsors worldwide, has announced its expansion into India with the establishment of a local company and the opening of its new office in Bengaluru. The site is home to Bioforum's India Global Capability Centre (GCC), a strategic hub that brings together experienced clinical data managers, statistical programmers, standards experts, and technology specialists as part of the company's global delivery organization. The India GCC joins Bioforum's global operations across the United States, Europe, Colombia, and South Africa, strengthening the company's follow-the-sun delivery model and its ability to deliver clean, compliant, submission-ready clinical data around the clock. The India GCC is led by Dr Santhosh Kumar, Senior Vice President, India and Global Capability Center, who brings over 24 years of experience in the CRO and healthcare industry building and leading large-scale clinical data and global delivery organisations. The centre is expected to grow significantly over the coming year across clinical data management, statistical programming, clinical coding, validation, and other core delivery capabilities. ]]> https://biospectrumindia.com/news/97/28284/biodeal-pharmaceuticals-raises-rs-385-cr-growth-investment-from-rmb-capitalworks-.html https://biospectrumindia.com/news/97/28284/biodeal-pharmaceuticals-raises-rs-385-cr-growth-investment-from-rmb-capitalworks-.html Mon, 10 Aug 2026 18:35:11 +0530 Biodeal Pharmaceuticals, one of India's leading specialty pharmaceutical Contract Development and Manufacturing Organisations (CDMOs), has announced a growth investment of Rs 385 crore from RMB Capitalworks, a joint venture between Rand Merchant Bank and Capitalworks Group. The investment marks a significant milestone in Biodeal's growth journey and will support the company's next phase of expansion across specialty pharmaceuticals, manufacturing capabilities, and regulated markets. he investment will support Biodeal's next phase of expansion, strengthening its positions across Asian markets while accelerating growth across CIS, LATAM, Africa and Europe. "This investment represents much more than capital - it is a strong endorsement of the platform we have built over the past two decades. At Biodeal, we have consistently focused on creating differentiated capabilities in specialty pharmaceuticals, anchored by leadership in nasal drug delivery and a relentless focus on quality and manufacturing excellence. This milestone reflects the strength of what we've built and the scale of what lies ahead," said Anurag Kumar, CMD, Biodeal Pharmaceuticals. "We work closely with founders to co-create solutions that unlock personal value and provide the long-term financial stability needed to execute ambitious growth plans. Healthcare is a core focus for us, and Biodeal fits our thesis of a differentiated player primed for rapid growth," said Anshuman Malur, Managing Partner, RMB Capitalworks. Biodeal has delivered consistent profitable growth over the past five years, with FY26 revenue estimated to grow 60%+ year-on-year and EBITDA margins expanding further. The company is entering its next phase of growth with a clear ambition; to strengthen its position as a globally trusted specialty pharmaceutical partner while advancing confidently on its path towards a planned public listing. ]]> https://biospectrumindia.com/news/97/28255/piramal-pharma-solutions-expands-peptide-api-facility-with-advanced-spray-drying-suite.html https://biospectrumindia.com/news/97/28255/piramal-pharma-solutions-expands-peptide-api-facility-with-advanced-spray-drying-suite.html Wed, 05 Aug 2026 13:02:52 +0530 Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma, has launched a state-of-the-art spray drying suite at its dedicated peptide development and manufacturing facility in Turbhe. This strategic expansion enables PPS to address the complex formulation challenges associated with peptides and other complex molecules and support the growing demand for these innovative molecules. Spray drying transforms liquid formulations into dry powders in a single step, enabling drug developers to enhance bioavailability, achieve precise particle size, and process sensitive compounds safely. This technique is especially critical for peptides, which are unstable at high temperatures and often require strict control over particle properties. Its gentle and efficient nature enables drug developers to improve solubility, streamline scale-up, and increase speed, all while preserving the molecular integrity of their peptide API. The new spray drying suite operates as a closed-loop system, equipped with its own inert gas supply and advanced safety measures, including specialized HVAC, airlocked entries and exits, operator isolation, and a dedicated cleaning area. This enables the safe handling of potent compounds and organic solvents requiring up to Band 5 containment. To further strengthen these capabilities, the processing area maintains ISO Class 8 (Class 100,000) cleanliness standards, ensuring strict control of the environment throughout operations. Engineered for small-volume, high potency batches, the unit supports a feed rate of up to 1 liter per hour. It can spray dry highly concentrated solutions — even those with up to 30% water content — making it particularly valuable for the formulation of biomolecules and large peptides. Under optimal conditions, the suite can also be leveraged for low-volume small-molecule formulations. ]]> https://biospectrumindia.com/news/97/28258/gland-pharma-and-neuland-labs-announce-strategic-collaboration-for-sterile-api-manufacturing.html https://biospectrumindia.com/news/97/28258/gland-pharma-and-neuland-labs-announce-strategic-collaboration-for-sterile-api-manufacturing.html Wed, 05 Aug 2026 17:58:20 +0530 Gland Pharma and Neuland Laboratories have announced a long-term strategic CDMO partnership. Under the partnership Gland will establish a sterile manufacturing suite for Active Pharmaceutical Ingredients (APIs) pertaining to microparticle depot products. The collaboration combines Neuland's Complex API development and manufacturing capabilities including deep expertise in complex chemistry, process development, custom manufacturing having a strong track record of serving global innovator and generic pharmaceutical companies; with Gland Pharma's global sterile manufacturing expertise and strong regulatory compliance track record, to serve growing worldwide demand for sterile APIs used in microparticle depot products and other complex sterile APIs. The collaboration represents a significant expansion of the relationship between the two companies, creating a dedicated manufacturing platform that aligns their complementary capabilities under a long-term strategic partnership. Under the collaboration, Gland Pharma will expand its existing sterile manufacturing infrastructure through an additional dedicated suite at its JNPC facility at Visakhapatnam to support Neuland for its growing demand of sterile APIs. The facility will be constructed and operated to cGMP, USFDA and EU standards, and will be backed by Gland Pharma's proven aseptic manufacturing expertise. Together, the companies will offer an integrated CDMO solution encompassing development, scale-up, regulatory support and commercial manufacturing of sterile APIs. The suite will be designed to add approximately 1400 kg of annual capacity, providing manufacturing flexibility across multiple sterile products while supporting future growth. The partnership is expected to enhance supply resilience globally by combining Neuland's development and regulatory expertise with Gland Pharma's manufacturing capabilities.       ]]> https://biospectrumindia.com/news/97/28250/enzene-launches-nex-for-high-yield-local-organic-biopharma-production.html https://biospectrumindia.com/news/97/28250/enzene-launches-nex-for-high-yield-local-organic-biopharma-production.html Tue, 04 Aug 2026 12:36:43 +0530 Enzene, Pune-based continuous innovation development and manufacturing (CIDMO) company, has announced the launch of NeX™, a transformative end-to-end partnership model that enables governments, institutions and biopharmaceutical companies to build world-class biomanufacturing capabilities where they need them. Leveraging the proven EnzeneX Fully-Connected Continuous Manufacturing™ (FCCM)™ platform, NeX offers a turnkey, scalable, and sustainable solution to make cutting-edge biologics manufacturing innovations transferable, close to patients and supply chains, without the prohibitive upfront investment required by conventional fed-batch facilities. By promoting local manufacturing based on the FCCM platform, governments can significantly improve affordability and patient access to life-saving biologics.® Enzene's NeX programme includes full coordination of set-up and launch, with support for facility design and construction, technology transfer and intellectual property licensing for the EnzeneX platform, staff skills development through the company's SparX™ structured training programme, as well as ongoing operational support during the start-up and commercialisation phase. Where appropriate, participating organisations will also be able to benefit from access to certain products from Enzene's biosimilar portfolio in order to manufacture them in their own regions. "Building a conventional biologics plant often requires between $300 million and $400 million. With our fully connected continuous manufacturing platform, it is possible to achieve the same level of production at a cost of between $60 million and $80 million", said Himanshu Gadgil, Ph.D., CEO of Enzene. ]]> https://biospectrumindia.com/news/97/28175/hikal-commissions-cgmp-pilot-plant-in-pune-to-strengthen-pharma-capabilities.html https://biospectrumindia.com/news/97/28175/hikal-commissions-cgmp-pilot-plant-in-pune-to-strengthen-pharma-capabilities.html Wed, 22 Jul 2026 15:53:27 +0530 Hikal Limited, a leading partner to global pharmaceutical, crop protection and specialty chemical companies, has announced the successful commissioning of its enhanced current Good Manufacturing Practice (cGMP)-compliant pilot plant facility at its Pune Research & Technology (R&T) campus. The expansion strengthens Hikal's integrated capabilities across process development, scale-up, technology transfer and clinical-stage manufacturing at its Innovation Campus at Pune, enabling the company to partner more effectively with global pharmaceutical customers from early development through commercial manufacturing readiness. The upgraded pilot plant supports process development, technology transfer and clinical-stage manufacturing while adhering to global quality and regulatory expectations. By creating a stronger bridge between laboratory-scale research and commercial-scale production, the facility is designed to help customers accelerate development timelines, improve process robustness and generate high-quality material for regulated development programmes. It also enables the manufacture and supply of preclinical and clinical-phase development materials from the same R&T campus, allowing scientists and engineers to closely monitor processes, enhance cross-functional collaboration and reduce technology-transfer timelines to support timely project delivery for its innovator customers The new pilot facility is designed to support flexible, cGMP-compliant scale-up across a wide range of chemistries. Its infrastructure includes reactors ranging from 20 litres to 2,000 litres, with stainless steel and glass-lined materials of construction as well as distillation and filtration through advanced equipment, including Hastelloy Agitated Nutsche Filter Dryers (ANFD) The facility also offers broad process capabilities, including cryogenic reactions, hydrogenation capabilities and high-temperature reactions and high-vacuum distillation capabilities etc. ]]> https://biospectrumindia.com/news/97/28137/sharrp-ventures-leads-rs-100-cr-investment-in-naturis-cosmetics-first-institutional-funding-round.html https://biospectrumindia.com/news/97/28137/sharrp-ventures-leads-rs-100-cr-investment-in-naturis-cosmetics-first-institutional-funding-round.html Thu, 16 Jul 2026 17:05:34 +0530 Naturis Cosmetics, a CDMO specialising in the beauty & personal care (BPC) sector, has raised Rs 100 crore in its first external funding round. The investment was led by Sharrp Ventures, with participation from Mirabilis Investment Trust (Infosys Co-founder K. Dinesh Family Office), financial growth equity investors Anicut Capital and Niveshaay, D2C ecosystem leaders including Suyash Saraf (Hyperscale Ventures) and Yogesh Kabra, along with several prominent angel investors from pharma and specialty chemical ecosystems.  The Mumbai-based company has partnered with several pharmaceutical companies like Glenmark and Dr. Reddy’s Laboratories for new-age OTC and cosmeceuticals backed by unique technologies.  The fresh capital will enable Naturis Cosmetics to accelerate its vision of leading the next decade of innovation and growth in the BPC sector. It aims to become the platform of choice for beauty, personal care, and wellness brands across D2C, FMCG, and OTC pharma. The company also plans to expand its geographical presence across the country by establishing a new state-of-the-art production unit in Vapi, spanning 225,000 sq. ft, an experience centre in the NCR region, and a new R&D centre in Mumbai. Additionally, it will significantly scale its team across verticals.  Over the next five years, Naturis intends to diversify into high-growth categories, including men’s grooming, body care, colour cosmetics, fragrances, and exports, while strengthening its capabilities in OTC pharma. The company also plans to deepen its innovation funnels with both existing and new brands.    ]]> https://biospectrumindia.com/news/97/28124/onesource-specialty-pharma-and-formycon-ag-announce-strategic-manufacturing-partnership-for-biosimilars.html https://biospectrumindia.com/news/97/28124/onesource-specialty-pharma-and-formycon-ag-announce-strategic-manufacturing-partnership-for-biosimilars.html Tue, 14 Jul 2026 19:53:14 +0530 Bengaluru-based OneSource Specialty Pharma, a multi-modality specialty pharma CDMO, and Formycon AG, an independent biosimilar developer headquartered in Munich, have announced a strategic manufacturing partnership for biosimilars. Under the partnership, OneSource will serve as a strategic manufacturing partner for Formycon and provide integrated Drug Substance (DS) and Drug Product (DP) manufacturing capabilities from its state-of-the-art biologics’ facility in Bangalore. The collaboration brings together Formycon´s Biosimilar development excellence with OneSource's end-to-end biologics manufacturing expertise to support Formycon's biosimilar programs for global markets. The partnership reflects the shared commitment of both companies to advancing global access to biosimilars through reliable, high-quality, and scalable manufacturing. Achieving this requires not only scientific excellence but also a sustainable, cost-effective manufacturing model — that OneSource is specifically positioned to deliver. Formycon brings a strong track record in biosimilar development and commercialisation, supported by an established portfolio and a robust pipeline. OneSource complements this with an integrated biologics platform spanning cell line development through commercial fill-finish, five manufacturing facilities approved by leading global regulatory authorities, including the US FDA and EMA, and extensive expertise across biologics, sterile injectables, and drug-device combinations. ]]> https://biospectrumindia.com/news/97/28053/akums-launches-novel-triple-action-therapy-for-comprehensive-neuropathy-management.html https://biospectrumindia.com/news/97/28053/akums-launches-novel-triple-action-therapy-for-comprehensive-neuropathy-management.html Wed, 01 Jul 2026 16:58:52 +0530 Akums Drugs & Pharmaceuticals, Delhi-based contract development and manufacturing organisation (CDMO), has announced the launch of its DCGI-approved Pregabalin, Methylcobalamin and Duloxetine (Delayed Release) Capsules, a novel triple-action therapy for the management of diabetic peripheral neuropathic pain associated with Vitamin B12 deficiency. Neuropathy is emerging as a significant public health concern in India, driven by the growing prevalence of diabetes and nutritional deficiencies. India is home to more than 100 million people living with diabetes, and studies suggest that nearly 25–50% of diabetic patients may develop neuropathy during the course of their disease. Vitamin B12 deficiency, reported in a large proportion of urban Indians, further contributes to symptoms such as tingling, numbness, fatigue, and cognitive changes, making effective management increasingly important. The newly launched formulation combines Pregabalin 75 mg, Methylcobalamin 1500 mcg, and Duloxetine 20 mg/30 mg (Delayed Release), bringing together three complementary therapeutic mechanisms. Pregabalin helps reduce abnormal nerve firing and provides relief from neuropathic pain symptoms. Duloxetine modulates central pain pathways by inhibiting serotonin and norepinephrine reuptake, while also supporting improvements in associated anxiety and sleep disturbances. Methylcobalamin, the neurologically active form of Vitamin B12, supports myelin sheath repair, improves nerve conduction, and aids in the regeneration of damaged nerve fibres. A key differentiator of the therapy is its advanced dual-delivery technology, which enables the immediate and consistent release of Pregabalin and Methylcobalamin while ensuring targeted intestinal delivery of Duloxetine. This innovative design helps optimise the absorption profile of each active ingredient, supporting enhanced therapeutic effectiveness and patient comfort. The formulation is designed to promote therapeutic consistency, improve convenience, and encourage long-term treatment adherence.   The CNS and neuropathy treatment market in India is expanding steadily, driven by increasing disease prevalence, improved diagnosis rates, and growing awareness among healthcare professionals and patients. Combination therapies are gaining prominence as they address multiple disease pathways while simplifying treatment regimens. ]]> https://biospectrumindia.com/news/97/28055/morepen-starts-commercial-supplies-under-rs-825-cr-cdmo-mandate.html https://biospectrumindia.com/news/97/28055/morepen-starts-commercial-supplies-under-rs-825-cr-cdmo-mandate.html Wed, 01 Jul 2026 17:08:21 +0530 Morepen Laboratories has issued an update on its recently announced Rs 825 crore CDMO mandate. The first commercial dispatch, valued at approximately Rs 50 crore, has already been completed by the company under the programme during Q1FY2026-27. This marks the successful transition of the mandate from validation and qualification stage to commercial execution stage. Commenting on the development, Sanjay Suri, Managing Director, Morepen Laboratories, said, “This is an important milestone in Morepen’s transition toward long-duration global manufacturing partnerships. Our teams have worked closely with the customer through validation, manufacturing readiness and supply-chain planning. Having started execution of commercial supplies, we are focused on scaling up, expanding capacity and building a stronger CDMO platform across additional customer and product opportunities.”  Having dispatched the first batch under the CDMO mandate, Morepen expects to scale the program further in the coming quarter, with additional supplies of approximately Rs 225 crore expected during Q2FY2026-27, subject to customer schedules and regulatory/commercial requirements. The company continues to strengthen its manufacturing infrastructure to support larger contract development and manufacturing organisation (CDMO) opportunities. Total reactor capacity is expected to reach approximately 600 KL by the end of Q2, followed by further expansion toward 800 KL and 1,000 KL in subsequent phases. The commencement of commercial supplies under this mandate reinforces Morepen’s strategy to build a scalable CDMO platform, deepen customer partnerships and participate in long-duration global manufacturing opportunities. ]]> https://biospectrumindia.com/views/97/28040/the-next-chapter-of-clinical-trials-is-about-the-evidence-we-generate-for-indian-patients-in-indian-settings.html https://biospectrumindia.com/views/97/28040/the-next-chapter-of-clinical-trials-is-about-the-evidence-we-generate-for-indian-patients-in-indian-settings.html Mon, 29 Jun 2026 16:18:43 +0530 SIRO Clintech is repositioning itself from a traditional CRO to a Lifecycle Evidence Partner. What specific gaps in the current pharmaceutical ecosystem prompted this transformation? Dr Gautam Daftary- The traditional CRO model was built for a different era. Sponsors hired us to execute discrete projects: a Phase III trial here, a publication there, a PMS (post marketing surveillance ) programme after the product launch. We delivered each piece competently in isolation. What we watched unfold over two decades is that data and insights generated within one project rarely informed the next. A trial would close, the dataset would lock away, and a year later the same molecule would face a guideline body, a payor, or a prescriber community asking exactly the questions that dataset could have answered. The second gap is uniquely Indian. We have built, over three decades, the operational and scientific capability to run trials to global standards. What we have not built at industry scale is the connective tissue between trial data, real-world evidence, post-approval programmes, and publication output that turns a molecule’s clinical story into prescriber confidence and guideline alignment. Sponsors increasingly need a partner who treats evidence as a continuum rather than a sequence of transactions.   What are the major plans in store for FY 26-27? Please share the details. Karan Daftary- FY 26-27 has four explicit workstreams under our Lifecycle Evidence Partner architecture. First, deepening Development Clinical Trials capability, particularly in metabolic, hepatic, and respiratory portfolios, where Indian sponsors are increasingly running pivotal Phase III programmes. Second, scaling Post-Approval Clinical Programmes, including a structured offering that mines historical Clinical Study Reports to surface publication-ready evidence sponsors didn’t realise they already owned. Third, expanding Real-World Evidence generation tied to Indian prescriber and patient populations, where unmet need is significant. Fourth, our differentiator: Evidence Platforms and Intelligence, the technology layer delivered through SIROai, which gives sponsors structured access to patient conversations and discussions about the drug  on social media – we call that patient voice, investigator intelligence and centralised reading capability. One question Indian CROs rarely get asked, and one worth answering directly: how much does a CRO invest in R&D? The easy assumption is that buying a few off-the-shelf SaaS tools amounts to a technology strategy. That assumption is wrong- In our case, SIROai is the outcome of more than five years of foundational platform development. The wider technology organisation SIROai sits within, also runs an ISO 13485-certified diagnostics AI business, which speaks to the engineering and governance depth behind our broader platform work. That level of sustained R&D investment is uncommon in the Indian CRO landscape. SIROai will be one of the principal drivers and enablers of the lifecycle model we are building over FY 26-27 and beyond. We expect meaningful growth this year, driven less by trial-volume expansion and more by sponsors consolidating multiple evidence workstreams with a single partner.   What are the current challenges and opportunities facing the Indian CRO market? Karan Daftary- The Indian CRO market is in a more interesting position than it gets credit for. The challenge is real. Margin compression on traditional trial execution, sponsor consolidation, and a global perception that India is a low-cost site rather than a strategic evidence partner. Cost-arbitrage models are running out of room. The economics no longer work for anyone competing only on price. Indian pharma is moving from generics to specialty and innovator molecules at scale. Indian sponsors are increasingly publishing in global journals, presenting at international congresses, and seeking guideline inclusion for their assets. That requires a different kind of CRO partner: one with publication capability, real-world evidence infrastructure, regulatory depth, and analytical platforms to mine existing trial data The CROs who will define the next decade in India aren’t competing on per-patient cost. They are competing on evidence yield per dataset. A single well-designed Phase III, run with the right architecture, can generate ten to twenty publications, multiple post-approval extensions, and a real-world evidence programme that shapes guidelines for years. That is the conversation Indian sponsors want to have now. The CRO of the next decade will be defined by something different: how it embeds technology inside its own workflows, governed by the quality systems sponsors require, drawing on the operational and scientific expertise its people have built up over years. SIROai is our technology platform and is our enabler for the lifecycle model and is we are already partnering with some of our pharma sponsors to help them harness their existing trial data   Real-world evidence (RWE) is increasingly influencing regulatory and commercial decisions. How can pharmaceutical companies better leverage RWE to improve patient outcomes and product adoption? Karan Daftary- The first shift is to stop treating RWE as a regulatory checkbox or a post-launch afterthought. Companies getting genuine value from RWE in India design the evidence question upstream, often before launch and sometimes before Phase III readout, and then build the data infrastructure to answer it longitudinally. That changes everything about how the programme is scoped. The second shift is recognising that India’s RWE opportunity is not the Western HEOR-and-payor model. Indian medical affairs teams aren’t building dossiers for HTA bodies. They are building prescriber confidence, shaping treatment guidelines, and equipping field teams with locally relevant evidence. The buyer is medical affairs, the currency is clinical insight, and the deliverable is content that lands with Indian prescribers: adherence patterns, sub-population responses, real-world tolerability, comparator context in actual Indian practice. Third, draw on patient voice systematically. Most sponsors still treat patient experience as qualitative colour. Structured patient voice intelligence, gathered at scale, longitudinally, and integrated with clinical data, answers questions sponsors don’t yet know they should be asking. We treat patient voice and investigator intelligence as evidence streams in their own right, on the same footing as clinical data, and feed them back into the publication and medical affairs engine. There is a fourth dimension to this that doesn’t always sit neatly under the RWE label, but increasingly belongs in the conversation. Social media has been one of the most empowering shifts for the Indian citizen, giving every patient and caregiver a voice they did not have a decade ago. It has also produced an environment where content travels on virality rather than on scientific accuracy. Some of what circulates around major therapeutic categories has no evidence base. The governance question that sits over those platforms is properly the domain of policy-makers and regulators. But pharma companies in India face a practical, immediate question: what is being said about their molecules, their categories, their indications, and how do they respond with accurate, evidence-grounded information? That question is one we can help answer directly. Our social and digital listening infrastructure, paired with AI-based classification tools, gives Indian sponsors the ability to monitor public conversations at scale, distinguish credible content from misinformation, and generate the evidence-based response their medical affairs teams need. It is real-world signal capture applied to a question pharma companies have historically had to handle on instinct.   From building clinical research capabilities in India to now advocating for integrated evidence generation, what do you see as the next major chapter in India’s contribution to global healthcare innovation? Dr Gautam Daftary- The first chapter was capability. When we started, the question global sponsors asked about India was whether trials could be run here to international standards. That question is settled. India runs pivotal programmes for the world’s largest pharmaceutical companies, and Indian sponsors run programmes that compete head-on with global molecules. The infrastructure exists, the scientific community exists, and the regulatory framework has matured considerably. The next chapter, in my view, is about the evidence we generate for Indian patients in Indian settings. The first chapter answered the question of whether molecules can be tested in Indian populations to international standards. We proved that they can. The next chapter answers a fundamentally different question. How do those molecules actually perform in real Indian clinical practice, with Indian patients, on Indian care pathways, with the comorbidity profiles and prescribing patterns and adherence realities that an Indian physician actually sees? That is what real-world evidence actually means. Evidence for India, not evidence from India. Consider the scale of that need. India has over a hundred million people living with prediabetes, large populations with non-alcoholic fatty liver disease, distinctive hepatitis profiles, oncology patterns that present quite differently from Western cohorts, and patient cohorts on multi-drug treatment combinations that look nothing like the clean homogeneity of trial protocols. Indian physicians have been making prescribing decisions for those patients using evidence generated elsewhere, for cohorts that are not theirs, in healthcare systems that are not theirs. The next chapter is about generating the evidence here, for them, in the conditions in which they actually practice. When that evidence subsequently informs global guideline conversations, and it will, that follows naturally. The design priority is the Indian patient and the Indian prescriber. That is the shift we are trying to lead from SIRO Clintech. Indian medicines, evaluated in Indian conditions, with evidence that reaches Indian patients first. It is a meaningfully different ambition from the trials-done-in-India era, and it is the chapter that justifies the Lifecycle Evidence Partner repositioning.   How do you envision the growth of clinical research and clinical trials in India? Are there any major expectations from the government? Dr Gautam Daftary- Over the last decade, Indian regulation has matured category by category in a way that has tracked how the industry itself has accumulated experience. The New Drugs and Clinical Trials Rules 2019 created a more predictable, codified framework in place of what had previously been a more interpretation-heavy regime. The biosimilar guidelines, revised in 2016 and progressively aligned with WHO and global standards, were shaped by India’s own decade of experience as a biosimilar manufacturing hub. The Pharmacovigilance Programme of India has grown from inception into a structured national reporting system. Subject Expert Committee processes have become more transparent and more consistent year on year. Across categories, the pattern that emerges is one of a regulator translating sectoral experience into the rule framework as that experience accumulates. The biosimilar example is the one I find most instructive. India was one of the first countries to build a domestic biosimilar industry at meaningful scale. The regulatory framework evolved as the experience accumulated. The outcome is that Indian patients have access to biological therapies at a fraction of innovator-market pricing within the safety standards the framework codified. Looking across categories, the pattern is consistent. As a therapeutic area matures, the regulatory framework moves in step with it, addressing access, pricing structure and safety architecture together rather than in isolation. That pattern, in my reading, is the most useful frame for thinking about where things go next. The same cycle appears to be approaching in several of the areas where experience is currently accumulating. Real-world evidence is one of them. India is generating real-world data at scale, through pharmacovigilance, through post-marketing surveillance, through investigator-initiated research, and increasingly through digital health platforms. A formal RWE framework of the kind the FDA has been building is not yet in place here. When one does take shape, it will draw on the Indian-specific evidence work being done today. Health Technology Assessment (HTA) is another. HTAIn has been operational under the Department of Health Research in India since 2017, and the conversation that appears to be developing is how formal HTA frameworks integrate, over time, with pricing, reimbursement and access decisions. Cell and gene therapy is a third area where the science is moving rapidly and the regulatory architecture sits at an earlier stage of the same cycle. My expectation from government, then, is less of a list of specific asks and more a reading of where the trajectory is heading. Each step in this maturation cycle, taken in step with sectoral experience, has historically produced outcomes that align both industry and patient interests. I see RWE frameworks, HTA frameworks, pharmacovigilance evolution and the emerging digital health infrastructure all converging into a more integrated regulatory ecosystem over the next several years. That convergence in my view will be an important thread that will help shape future Indian healthcare policy direction.   Dr Manbeena Chawla (manbeena.chawla@mmactiv.com) ]]> https://biospectrumindia.com/news/97/28028/shilpa-biologicals-announces-commission-of-adc-gmp-facility-in-dharwad.html https://biospectrumindia.com/news/97/28028/shilpa-biologicals-announces-commission-of-adc-gmp-facility-in-dharwad.html Thu, 25 Jun 2026 19:31:57 +0530 Shilpa Biologicals, a subsidiary of Shilpa Medicare, has announced the commissioning of a state-of-the-art Antibody–Drug Conjugate (ADC) GMP manufacturing facility in Dharwad, purpose-built and designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements. The facility is fully operational, with GMP qualification protocols now actively underway, placing Shilpa on a clear path to commercial readiness. This commissioning marks a natural and powerful evolution of Shilpa Medicare’s over 25 years of deep-rooted expertise in highly potent compound manufacturing. Since its early years, Shilpa has built one of India’s most robust high potency API platforms — a discipline demanding the most exacting standards of containment, safety engineering, process rigour, and regulatory compliance.  Sridevi Khambhampaty, CEO, Shilpa Biologicals commented, “The manufacturing of highly potent compounds has been a core pillar of Shilpa’s identity and this ADC drug substance facility adds a new sophisticated dimension to the capabilities of the Shilpa group, we now offer global biotech and pharma partners a uniquely integrated ADC facility built with the knowledge of our existing high potency manufacturing excellence.” With this commissioning, Shilpa Medicare becomes one of the very few companies in India to offer fully integrated, end-to-end ADC drug substance development and manufacturing — encompassing payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and purification of GMP-scale drug substance. The manufacture of ADC drug substance demands specialised cytotoxic payload containment, precise conjugation chemistry, and rigorous biologic purification — all within a GMP-validated environment.  This positions Shilpa as a compelling, cost-competitive CDMO partner for global pharmaceutical and biotech companies seeking high-quality, integrated ADC drug substance solutions.   ]]> https://biospectrumindia.com/news/97/28006/quantoom-and-nucelion-therapeutics-to-expand-rna-capacity-in-india.html https://biospectrumindia.com/news/97/28006/quantoom-and-nucelion-therapeutics-to-expand-rna-capacity-in-india.html Tue, 23 Jun 2026 16:24:00 +0530 Belgium-based Quantoom (operating as Phoenix Biosciences SA) and Hyderabad-based Nucelion Therapeutics have announced the signing of a Memorandum of Understanding (MoU) to explore a preferred RNA contract development and manufacturing (CDMO) partnership in India. Under the MoU, Nucelion would operate Quantoom’s N-Force platform technologies to provide both research-grade and GMP-grade RNA manufacturing services to clients across human therapeutics and animal health. The collaboration reflects a shared view of the significant and growing opportunity for RNA-based products in India and the broader Asia-Pacific region — spanning mRNA therapeutics, RNA-based vaccines, oligonucleotide therapies, and veterinary applications. Quantoom’s N-Force toolbox supports the rapid development of (sa)mRNA as a drug modality — from design through RNA production and encapsulation — via its Ntensify® equipment and consumables, reagent pre-mixes, and Ncapsulate® QCX delivery technology. Through the intended partnership, Nucelion aims to establish and scale RNA CDMO capability at its facilities in India, supported by Quantoom technology transfer and technical expertise. ]]> https://biospectrumindia.com/news/97/27979/neuland-to-open-20-m-dedicated-process-development-facility-with-integrated-kilo-labs-in-hyderabad-.html https://biospectrumindia.com/news/97/27979/neuland-to-open-20-m-dedicated-process-development-facility-with-integrated-kilo-labs-in-hyderabad-.html Tue, 16 Jun 2026 19:11:25 +0530 Neuland Laboratories, a global contract development and manufacturing organisation (CDMO) specialising in complex APIs, will open a dedicated process development laboratory and integrated kilo lab at its Genome Valley campus in Hyderabad. The new 135,000 sq. ft. facility will see $20 million invested in a specialist fit-out and be operationalised in phases, with full completion expected by October 2026. Significantly, it has been designed as a purpose-built integrated scale-up laboratory dedicated exclusively to process development. Once completed, the site will take Neuland’s process development team to more than 500 scientists, making it one of the largest scale-up workforce in India. The centre will incorporate AI-driven route scouting, parallel synthesis, and Electronic Laboratory Notebooks (ELNs), enabling faster decision-making, reduced cycle times, and seamless data continuity. A centralised analytical wing will house a comprehensive suite of characterisation technologies, with the facility also including specialised zones for process engineering, polymorph studies, process safety, and advanced flow chemistry, alongside five peptide labs and three purification labs. The Kilo Lab will be equipped with 20–250 L all‑glass reactors, cryogenic capability, and multiple filtration systems. By bridging bench chemistry and plant operations, the Kilo Lab ensures processes are engineered with manufacturability in mind from the outset. ]]> https://biospectrumindia.com/news/97/27917/maiva-pharma-opens-sterile-injectable-manufacturing-facility-in-tamil-nadu.html https://biospectrumindia.com/news/97/27917/maiva-pharma-opens-sterile-injectable-manufacturing-facility-in-tamil-nadu.html Mon, 08 Jun 2026 15:28:53 +0530 Maiva Pharma, a leading global Contract Manufacturing Organisation (CMO) and Contract Development and Manufacturing Organisation (CDMO) specialising in sterile injectables, has inaugurated its new manufacturing facility at Shoolagiri, Tamil Nadu, India. The facility marks a significant milestone in Maiva's growth journey, further strengthening its position as a trusted partner to global pharmaceutical and biotechnology companies for the development and manufacturing of generic and complex sterile injectable products. Spread across a 22-acre site, the new facility has been designed to support current and future market requirements through advanced manufacturing technologies, flexible production capabilities, and world-class quality systems. Upon full development, the facility will house six manufacturing lines capable of producing a broad range of sterile injectable dosage forms, including vials, pre-filled syringes (PFS), cartridges, suspension products, and lyophilised formulations. As part of the Phase 1 expansion, Maiva Pharma has commissioned three dedicated manufacturing lines comprising a high-speed vial filling line, a combined pre-filled syringe and cartridge line, and a lyophilisation line. The facility is further supported by advanced Quality Control chemical laboratories and state-of-the-art Microbiology laboratories, enabling comprehensive analytical testing and quality assurance functions in-house. A key highlight of the facility is its advanced isolator-based manufacturing lines for liquid vials, pre-filled syringes, cartridges, and lyophilised vials.  The isolator technology enhances sterility assurance, operational efficiency, and manufacturing flexibility while supporting the production of a wide range of injectable products for regulated global markets.   ]]> https://biospectrumindia.com/news/97/27905/theranym-biologics-opens-rs-1200-cr-manufacturing-facility-in-telangana.html https://biospectrumindia.com/news/97/27905/theranym-biologics-opens-rs-1200-cr-manufacturing-facility-in-telangana.html Wed, 03 Jun 2026 19:15:50 +0530 TheraNym Biologics, a contract manufacturing organisation by Aurobindo Pharma, has inaugurated its state-of-the-art manufacturing facility at Borpatla village in Sangareddy district, Telangana. Established with an investment of Rs 1,200 crore, the facility marks a significant addition to the state’s rapidly expanding biotechnology and pharmaceutical ecosystem. MSD has joined as the anchor customer for this new facility. The facility will manufacture advanced biologics and critical medicines used in the treatment of cancer and other life-threatening diseases, with products catering to both domestic and international markets, including the United States. TheraNym is equipped with advanced infrastructure designed to meet international regulatory standards. The establishment of TheraNym marks Aurobindo Pharma's strategic entry into the biologics contract manufacturing segment. Beyond enhancing healthcare innovation, the project is expected to generate employment opportunities for more than 1,500 local youth, contributing to regional economic growth and skill development. ]]> https://biospectrumindia.com/news/97/27898/aragen-to-manufacture-renaissance-pharmas-fda-fast-track-mab-in-bengaluru-facility.html https://biospectrumindia.com/news/97/27898/aragen-to-manufacture-renaissance-pharmas-fda-fast-track-mab-in-bengaluru-facility.html Tue, 02 Jun 2026 18:36:33 +0530 Aragen, a leading global Contract Research, Development, and Manufacturing Organisation (CRDMO), has successfully tech-transferred and manufactured the first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart – a humanised monoclonal antibody (mAb) targeting GD2 for high-risk neuroblastoma – in just 9 months. The anti-GD2 monoclonal antibody received Fast Track Designation from the FDA in April 2026 for the treatment of high-risk neuroblastoma (HRNB), a rare pediatric cancer. This milestone builds on a broader strategic partnership between the two companies, with Aragen having developed the cell line and initial process at its Morgan Hill site in California. GMP manufacturing for the programme has now transitioned to Aragen’s commercial biologics facility in Bengaluru, India at the commercial scale.  The Aragen Bengaluru site plans to have multiple 2KL bioreactors enabling both scale-up and scale-out. This manufacturing strategy will allow the same molecule to be run across bioreactors, supporting faster readiness towards clinical and commercial supplies. The manufacturing suite is capable of producing 60-70 batches annually at 2 KL scale with a turnaround of one batch every 4–5 days at full capacity. Additionally, the suite can be operated in a scale-out mode with two 2 KL bioreactors running in parallel to provide a batch size of 4KL. This facility supports both fed-batch and intensified fed-batch production. The successful transfer to Aragen’s newly built $40 million commercial facility in Bengaluru marks an acceleration in clinical production. During the technology transfer to the new site, which features up to 2KL single-use bioreactor, the titer was increased several folds, with right-first-time execution from bench to 2KL GMP scale.  This latest tech transfer marks the sixth programme to progress from early-phase development in Morgan Hill to clinical supply in Bengaluru, demonstrating a discovery-manufacturing model designed to accelerate biotech programmes toward BLA submission. ]]> https://biospectrumindia.com/news/97/27832/piramal-pharma-solutions-inks-partnership-with-botanix-to-support-drug-substance-development.html https://biospectrumindia.com/news/97/27832/piramal-pharma-solutions-inks-partnership-with-botanix-to-support-drug-substance-development.html Tue, 19 May 2026 12:08:59 +0530 Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Mumbai-based Piramal Pharma, has entered a manufacturing and supply arrangement with Botanix SB Inc., a subsidiary of US-based Botanix Pharmaceuticals. Under this arrangement, PPS will initiate development and validation services for Sofpironium Bromide, the active pharmaceutical ingredient (API) in Sofdra®, at its Riverview, Michigan facility. Following successful regulatory approval at Riverview, PPS and Botanix will consider validating the process at PPS's Aurora, Canada facility. This potential twin-site strategy would give Botanix the option to use PPS as a dual-source commercial API supplier, enhancing its long-term supply chain flexibility and security. With decades of combined experience, the Riverview and Aurora facilities offer exceptional proficiency in drug substance development and manufacturing, spanning R&D through commercialisation. Recent investments have provided both facilities with the advanced equipment and unified systems required to execute this programme, reinforcing the strengths of their geographic proximity and integration expertise while enhancing their ability to offer cost-efficient solutions. ]]> https://biospectrumindia.com/news/97/27821/piramal-pharma-solutions-unveils-state-of-the-art-payload-linker-suite-in-us.html https://biospectrumindia.com/news/97/27821/piramal-pharma-solutions-unveils-state-of-the-art-payload-linker-suite-in-us.html Fri, 15 May 2026 12:46:56 +0530 Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma (PPS), has officially unveiled a new, state-of-the-art payload-linker development and manufacturing suite at its Riverview, Michigan drug substance facility. This launch is a key element of the company's broader $90 million investment plan to extend US-based manufacturing capabilities, announced last year. In addition to the payload-linker suite, the plan will add new technology and enhanced commercial-scale manufacturing capabilities at PPS's dedicated sterile injectables facility in Lexington, Kentucky. With over 60 years of drug substance development and manufacturing experience, Riverview is a distinguished leader in its field. Drawing on its diverse expertise, the site provides a comprehensive range of capabilities for APIs and HPAPIs. Leveraging its specialised Highly Potent Active Pharmaceutical Ingredient (HPAPI) knowledge and abilities, Riverview serves as PPS's dedicated payload-linker supplier, making it critical to ADCelerate™ – PPS's rapid, integrated approach to phase I antibody drug conjugate (ADC) development. The addition of this payload-linker suite is designed to help PPS accelerate partners' timelines and adapt to evolving market needs. Equipped with advanced containment, automation, and analytical technologies, the suite enables seamless scaling of payload-linker programmes. This further strengthens the ADCelerate™ platform and positions PPS to meet the rising demand for ADCs and other bioconjugate therapies. ]]> https://biospectrumindia.com/news/97/27806/shilpa-medicare-enters-strategic-partnership-with-nxi-therapeutics-ag.html https://biospectrumindia.com/news/97/27806/shilpa-medicare-enters-strategic-partnership-with-nxi-therapeutics-ag.html Tue, 12 May 2026 21:53:47 +0530 Shilpa Medicare, a global integrated pharmaceutical and CDMO company, has announced the signing of a long-term development and commercial manufacturing agreement with NXI Therapeutics AG, Switzerland. Under the terms of agreement, Shilpa group will provide comprehensive CMC development, process scale-up, GMP clinical supply, and commercial manufacturing support. The collaboration spans early development through commercialisation, positioning Shilpa as a lifecycle partner for the program. Autoimmune and immune-modulation segments represents one of the fastest-growing therapeutic categories globally, driven by increasing prevalence and demand for targeted immunotherapies. By securing this mandate at an early stage, Shilpa enhances its participation in high-value, innovation-driven pipelines with scalable commercial potential. This is the third named partnership deal Shilpa has announced in the past year, as the CDMO continues to expand rapidly amid strengthening demand from Western biotechs for its integrated R&D capabilities and advanced GMP manufacturing.  While financial terms remain confidential, the agreement includes milestone-linked expansion potential and may evolve into a multi-year commercial supply relationship, subject to successful clinical and regulatory progression. Vishnukanth Bhutada, Managing Director, Shilpa Medicare Limited, commented, “This collaboration reinforces Shilpa’s transformation into a strategic innovation partner for global biotech companies. Our integrated development and commercial manufacturing capabilities enable us to support complex assets across the full product lifecycle. We continue to see strong momentum in high-value biologics and specialty therapeutics, strengthening long-term growth visibility for our CDMO platform.” Dr Ruben Herrendorff, CEO, NXI Therapeutics AG, added, “Shilpa’s scientific depth, quality systems, and scalable GMP manufacturing capabilities make them an ideal partner as we advance our immunomodulatory program toward clinical and commercial milestones." ]]> https://biospectrumindia.com/news/97/27765/neuland-secures-development-collaboration-with-lir-life-sciences-for-transdermal-glp-1.html https://biospectrumindia.com/news/97/27765/neuland-secures-development-collaboration-with-lir-life-sciences-for-transdermal-glp-1.html Wed, 06 May 2026 22:05:49 +0530 Hyderabad-based Neuland Laboratories, a global contract development and manufacturing organisation (CDMO) specialising in complex APIs, has entered into a development partnership with LIR Life Sciences Corp, a Canada‑based biotechnology company focused on scalable and accessible obesity treatments, in advancing its cell‑penetrating peptide (CPP) platform. As part of this engagement, Neuland will develop, test, and manufacture CPPs to support pharmacokinetic (PK) and pharmacodynamic (PD) studies, as well as Phase I formulations for LIR Life’s transdermal GLP‑1/GIP programme.  LIR Life is developing a patch-based, transdermal delivery system for GLP-1 therapies targeting obesity. Unlike traditional injectable formulations, the platform is designed to enable non-invasive administration, with the potential to improve patient adherence and broaden access. Currently, there are no approved transdermal GLP-1 therapies, positioning this approach as a potentially significant innovation in the treatment landscape. For Neuland, the partnership highlights its expanding capabilities in peptide development and manufacturing, particularly in complex and emerging modalities such as CPP-enabled delivery systems. The company supports peptide programs from early development through commercial scale, with integrated capabilities spanning process development, scale-up, and cGMP manufacturing. The collaboration builds on Neuland’s recent investments in peptide infrastructure, including a new $20 million process development laboratory and a multi-phase commercial peptide manufacturing facility at its Bonthapally campus in Hyderabad. Module one of the peptide facility, representing an investment of approximately $30 million and 6,370 litres of capacity, is expected to become operational by mid-2026.   ]]> https://biospectrumindia.com/news/97/27742/aurigene-to-invest-100-m-across-small-molecules-peptides-neutraceuticals-and-biologics.html https://biospectrumindia.com/news/97/27742/aurigene-to-invest-100-m-across-small-molecules-peptides-neutraceuticals-and-biologics.html Tue, 28 Apr 2026 00:00:00 +0530 Aurigene Pharmaceutical Services announced a $100 million investment plan, earlier this year to accelerate growth in its CRDMO services across Small molecules, Peptides, Nutraceuticals and Biologics. In the first phase, Aurigene has deployed $40 million for their Genome Valley site at Hyderabad. This facility is designed to serve the cell line, clinical development & small-scale manufacturing of biologics assets of innovative biotechs and pharmaceutical manufacturers. The company has disclosed the details regarding the next phase of investment of around $60 million. Aurigene has deployed $20 million in building a state-of-the-art API & Intermediates block, adding more capacity at one of it’s FDA approved facility in Telangana. This new block is now fully operational and dedicated to innovator pharma manufacturers. The facility is uniquely equipped to handle a set of hazardous reactions in a very safe manner, setting a new industry standard. This reflects Aurigene’s commitment to next generation API manufacturing. The organisation is also investing $10 million to set up a dedicated GMP suite at its facility in Mirfield, UK, for small molecule manufacturing, to cater to the needs of European Biotechs and Pharmaceutical manufacturers. Furthering its leadership in innovation, Aurigene is making significant investments in peptide research, development and manufacturing through a comprehensive investment plan. Expansion of capacity in its pilot facility is completed and the new R&D lab is fully operational now. The expansion in large-scale GMP capabilities is underway. The company's peptide platform will feature advanced Micro-wave assisted synthesis, SPPS and LPPS, ensuring excellence for handling complex multi-mer peptide APIs (linear, branched & cyclic), intermediates and fragments. Specific information regarding investments across Nutraceuticals and Biologics services is yet to be disclosed by Aurigene Services.   ]]> https://biospectrumindia.com/news/97/27689/synsmart-partners-with-amporin-to-develop-small-molecule-therapeutics-for-degenerative-diseases.html https://biospectrumindia.com/news/97/27689/synsmart-partners-with-amporin-to-develop-small-molecule-therapeutics-for-degenerative-diseases.html Mon, 20 Apr 2026 00:00:00 +0530 Mumbai-based SynSmart Rasayan Research and Swiss firm Amporin Pharmaceuticals AG have announced a collaboration to develop breakthrough small molecule therapeutics for the treatment of deadly degenerative diseases. Under the terms of this collaboration, SynSmart will synthesise a substantial library of novel membrane-protecting molecules at its Mumbai research facility. Upon screening, the collaboration could be extended to follow-on chemistry as well as potential work in ADME-PK areas, with the intention to accelerate the project to candidate selection. SynSmart is a boutique chemistry CRDMO offering custom synthesis, medicinal chemistry and other services to over 40+ biotech and Big Pharma Customers under FTE or FFS based business arrangements. With a growing team of 125 chemists and capabilities in small molecules, complex peptides as well as technologies like photochemistry and flow chemistry SynSmart continues to strengthen its offerings in emerging modalities across key global markets. ]]> https://biospectrumindia.com/news/97/27682/piramal-pharma-solutions-partners-with-ajinomoto-bio-pharma-services-to-support-adc-development-and-manufacturing.html https://biospectrumindia.com/news/97/27682/piramal-pharma-solutions-partners-with-ajinomoto-bio-pharma-services-to-support-adc-development-and-manufacturing.html Sat, 18 Apr 2026 00:00:00 +0530 Mumbai-based Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma, and Japan-based Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical manufacturing services and platform technologies, have announced a strategic collaboration. Under this collaboration, Piramal will refer applicable customers seeking antibody drug conjugate (ADC) manufacturing technology to Aji Bio-Pharma and AJICAP™. Aji Bio-Pharma will refer Piramal to customers as a potential CDMO for manufacturing products using AJICAP™ technology, supporting their programs across development and manufacturing. Following the execution of this agreement, Piramal and Ajinomoto will enter into a separate Material Transfer Agreement (MTA) to allow the transfer of technology between companies. The MTA will equip Piramal with the expertise, capabilities, and personnel for it to manufacture AJICAP™-based products with precision and speed. With a global network of state-of-the-art facilities, Piramal has developed hundreds of ADCs, completed thousands of batches, and currently manufactures multiple commercial ADCs. Ongoing expansions are increasing Piramal's commercial-scale ADC capacity. ]]> https://biospectrumindia.com/news/97/27663/aurigene-pharma-collaborates-with-alveus-therapeutics-to-advance-peptide-and-small-molecule-programmes-for-metabolic-diseases.html https://biospectrumindia.com/news/97/27663/aurigene-pharma-collaborates-with-alveus-therapeutics-to-advance-peptide-and-small-molecule-programmes-for-metabolic-diseases.html Wed, 15 Apr 2026 00:00:00 +0530 Aurigene Pharmaceutical Services, an integrated drug discovery and CDMO partner and subsidiary of Dr. Reddy’s Laboratories, has announced progress in its research collaboration with US-based Alveus Therapeutics, a biotechnology company developing next-generation therapies for obesity and metabolic diseases. Under the collaboration, Aurigene provides integrated drug discovery services supporting Alveus’ research programmes in metabolic disease. It combines Alveus’ expertise in metabolic biology and therapeutic strategy with Aurigene’s discovery capabilities, including computational design, medicinal chemistry, and integrated biology platforms. The teams nominated ALV-200, a highly selective AMYR3 peptide candidate for metabolic disorders, as the first development candidate. The candidate is part of Alveus’ broader portfolio of next-generation therapies being developed for obesity and metabolic disease. Additional discovery programmes are ongoing as part of the collaboration supporting Alveus’ expanding research portfolio. Discovery efforts are supported by Aurigene.AI, Aurigene’s AI-enabled drug discovery platform integrating generative design, predictive modeling, and computational chemistry with high-throughput laboratory capabilities to support efficient design-make-test cycles.      ]]> https://biospectrumindia.com/news/97/27668/theranym-biologics-invests-150-to-175-m-for-establishing-manufacturing-facility-of-mammalian-cell-culture-bioreactors.html https://biospectrumindia.com/news/97/27668/theranym-biologics-invests-150-to-175-m-for-establishing-manufacturing-facility-of-mammalian-cell-culture-bioreactors.html Wed, 15 Apr 2026 00:00:00 +0530 Hyderabad-based TheraNym Biologics, a subsidiary of Aurobindo Pharma, has announced the addition to the existing CMO agreement with Merck Sharp & Dohme Singapore Trading, Singapore, (MSD) by execution of an additional product schedule. This serves to further expand the existing CMO relationship initiated pursuant to the previously disclosed arrangement in May 2024. Under this newly signed product schedule, TheraNym Biologics will construct greenfield project for commissioning a large scale mammalian drug substance manufacturing facility (Unit 2) housing a total of 60 KL bioreactor capacities. Theranym will invest around $150 to 175 million for establishing manufacturing facility of mammalian cell culture bioreactors with an aggregate capacity of 60,000 litres, together with requisite downstream purification infrastructure to produce drug substance. ]]> https://biospectrumindia.com/news/97/27602/saharsh-davuluri-takes-over-as-ceo-md-of-neuland-to-lead-cdmo-expansion.html https://biospectrumindia.com/news/97/27602/saharsh-davuluri-takes-over-as-ceo-md-of-neuland-to-lead-cdmo-expansion.html Wed, 01 Apr 2026 00:00:00 +0530 Hyderabad-based Neuland Laboratories [NLL], a global contract development and manufacturing organization (CDMO) specialising in complex APIs, has announced a leadership change. Saharsh Davuluri will assume the role of Chief Executive Officer (CEO) and Managing Director (MD), effective immediately, as the company moves into its next stage of CDMO growth. Davuluri has been with the company for more than 18 years and will position the CDMO as a premier global API process development and commercial manufacturing specialist. Neuland’s recent successes have been built on a growing reputation for scale-up of complex APIs and peptides, and the business has tripled its contract services revenues during the last 3-years. Davuluri has led Neuland’s transformation into a new chemical entity (NCE)-focused drug substance CDMO. In recent years, the company has secured a growing number of commercial manufacturing contracts with global innovator companies, reflecting rising demand for its strengths in process chemistry, scale-up, and reliable commercial supply. Davuluri succeeds Sucheth Davuluri, who has played a key role in the company’s transformation towards a CDMO‑focused business model and will now assume the role of Executive Vice Chairman of the Company. Neuland is embarking on an aggressive expansion phase and could, pending customer approvals, secure several more commercial NCE contracts [including peptides] over the next one to two years. The CDMO operates three US FDA-inspected manufacturing facilities and a 40,000 sq. ft. R&D facility, with 1218 KL of installed capacity and more than 20 commercial contracts across APIs and intermediates. The company’s recent growth has been supported by its ability to accelerate development timelines through parallel development strategies, while maintaining a strong regulatory track record across 18 US FDA inspections.   ]]> https://biospectrumindia.com/news/97/27588/hrv-pharma-and-shodhana-labs-forge-cdmo-alliance-to-fast-track-next-gen-api-development.html https://biospectrumindia.com/news/97/27588/hrv-pharma-and-shodhana-labs-forge-cdmo-alliance-to-fast-track-next-gen-api-development.html Mon, 30 Mar 2026 00:00:00 +0530 HRV Global Life Sciences (HRV Pharma), India's first integrated Virtual API and Pharmtech company, has announced a comprehensive, multi-year Contract Development & Manufacturing partnership with Shodhana Laboratories, a Hyderabad-based USFDA-aligned API manufacturer, to co-develop, manufacture and supply a curated pipeline of high-science APIs, including pharmaceutical-grade API’s primarily used in longevity biology, backed by a US Drug Master File (DMF).   This makes HRV the holder of the first and only active Indian DMF in this product as a pharmaceutical API. The collaboration brings together HRV's global market access across 50+ countries, AI-enabled Virtual API platform and regulatory DMF engine, with Shodhana's deep process chemistry, high-purity synthesis expertise and GMP infrastructure creating a seamless development-to-commercialisation pathway for molecules at the frontier of precision medicine.   The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework.   Under the multi-year agreement, both companies will jointly execute: Development and US DMF filing for pharmaceutical-grade API — a master coenzyme governing cellular energy, DNA repair and aging, now emerging as a regulated therapeutic API in oncology supportive care, neurodegeneration and longevity medicine. A pipeline of five high-science APIs spanning CNS, rare/orphan disease, and metabolic/neurological API’s — with partner anchor end-customers across the USA and EU End-to-end GMP manufacturing, CMC documentation, stability studies and validation aligned to USFDA, EMA, PMDA and ANVISA standards Global regulatory DMF filings across US, EU, LATAM, MENA & APAC with HRV managing all regulatory interactions and expenses A unified quality, compliance and audit-readiness framework for the highest tier of regulated market access ]]> https://biospectrumindia.com/news/97/27576/aragen-life-sciences-signs-mou-with-thermo-fisher-to-advance-biologics-manufacturing.html https://biospectrumindia.com/news/97/27576/aragen-life-sciences-signs-mou-with-thermo-fisher-to-advance-biologics-manufacturing.html Fri, 27 Mar 2026 00:00:00 +0530 Hyderabad-based Aragen Life Sciences has signed a Memorandum of Understanding (MoU) with Thermo Fisher Scientific to integrate Gibco™ cell culture media with its contract research, development, and manufacturing organization (CRDMO) capabilities. The collaboration covers process development, scale-up, and GMP manufacturing. The partnership combines Thermo Fisher’s cell culture media with Aragen’s expertise in establishing robust and scalable processes. It is intended to enable optimized upstream bioprocess development through the use of well-characterized, high-performance media. According to the company, the integration will streamline media–process fit, reduce variability, and accelerate technology transfer. These efforts are aimed at improving productivity across biologics manufacturing. The collaboration supports the advancement of biologics and biosimilars from early development through commercial manufacturing by enabling more efficient progression across development stages. The agreement focuses on end-to-end capabilities, including process development, scale-up, and GMP manufacturing, aligned with Aragen’s CRDMO services. ]]> https://biospectrumindia.com/news/97/27552/nucelion-therapeutics-enters-into-mou-with-nordic-cell-therapy-group.html https://biospectrumindia.com/news/97/27552/nucelion-therapeutics-enters-into-mou-with-nordic-cell-therapy-group.html Tue, 24 Mar 2026 00:00:00 +0530 Denmark-based Nordic Cell Therapy Group has entered into a Memorandum of Understanding (MoU) with Hyderabad-based Nucelion Therapeutics to explore opportunities for collaboration in the cell therapy space.The agreement establishes a framework to exchange expertise and evaluate potential areas of cooperation supporting the development and translation of advanced therapy programmes.By bringing together complementary perspectives from scientific, translational, and industrial environments, this collaboration aims to explore ways to support innovators developing next-generation cell therapies as part of a broader international ecosystem of partners and collaborators.Carlos Villaescusa, CEO, Nordic Cell Therapy Group said, “Building strong international collaborations is essential for advancing complex cell therapy programs. We look forward to exploring how our complementary expertise can support innovators developing next-generation therapies.”Dr Raghu V. Malapaka, CBO, Nucelion Therapeutics said, "This collaboration represents an important step in expanding our global partnerships and strengthening our ability to support innovators developing next-generation cell and gene therapies. Our common shared goal is to make these advanced therapies more accessible and affordable and bring meaningful impact to patients worldwide.” ]]> https://biospectrumindia.com/news/97/27516/lupin-manufacturing-solutions-announces-expansion-of-facility-at-dabhasa-gujarat.html https://biospectrumindia.com/news/97/27516/lupin-manufacturing-solutions-announces-expansion-of-facility-at-dabhasa-gujarat.html Thu, 19 Mar 2026 00:00:00 +0530 Lupin Manufacturing Solutions (LMS), a global contract research, development and manufacturing organisation (CRDMO) and subsidiary of global pharma major Lupin, has announced a strategic expansion of its Dabhasa (Gujarat) manufacturing facility, marking a significant step toward scaling its peptide building-blocks platform and CRDMO capabilities. The expanded infrastructure features a new block to enhance existing CRDMO capabilities supported by dedicated peptide manufacturing capacity across two additional specialized units. These upgrades will enable advanced development and flexible manufacturing, supporting complex therapeutics and meeting global demand for advanced pharmaceutical solutions. Dr Abdelaziz Toumi, Chief Executive Officer, Lupin Manufacturing Solutions, said, “As pharmaceutical innovation increasingly shifts toward complex modalities, building deep capabilities and execution excellence has become critical. This expansion underscores our commitment to building advanced, scalable capabilities that support complex development programs and reinforce our role in the global peptide ecosystem, enabling meaningful partnerships with innovators worldwide.” With global drug development increasingly defined by molecular complexity, such as peptides and biologic antibody drug conjugates (ADCs), this expansion reinforces LMS’s capability to consistently supply high‑quality peptide building blocks, including protected amino acids. ]]> https://biospectrumindia.com/news/97/27474/agilent-unifies-cdmo-capabilities-across-canada-and-united-states.html https://biospectrumindia.com/news/97/27474/agilent-unifies-cdmo-capabilities-across-canada-and-united-states.html Thu, 12 Mar 2026 00:00:00 +0530 Agilent Technologies Inc. has announced the launch of Agilent Advanced Therapeutics, a unified Contract Development and Manufacturing Organization (CDMO) solution integrating the company’s expanding capabilities across Canada and the United States. Agilent Advanced Therapeutics brings together the strengths of BIOVECTRA in Canada and Nucleic Acid Solutions in Colorado to deliver a full suite of premium, scalable and customisable manufacturing solutions. Agilent Advanced Therapeutics’ CDMO portfolio includes oligonucleotides, microbial fermentation, complex and synthetic chemistry, bioreagents, highly potent APIs, and cell line development. The integrated platform provides customers streamlined access to end-to-end development and manufacturing services through a single partner — from discovery and process development through clinical- and commercial-scale manufacturing. “The Agilent Advanced Therapeutics solution strengthens our ability to support our customers and reinforces our long-term commitment to growth, investment, and leadership in this space,” said Agilent President and CEO, Padraig McDonnell. “For our customers, this means a more integrated experience, deeper technical partnership and a trusted team that understands what it takes to bring life-changing therapies to patients.” Simon May, president of Agilent’s Life Sciences and Diagnostics Markets Group, added: “This launch reflects the combined excellence of our teams and our commitment to advancing the next generation of therapies. We are excited to bring our unified Agilent Advanced Therapeutics capabilities to partners around the world.” ]]> https://biospectrumindia.com/news/97/27456/neuland-to-open-commercial-peptide-facility-as-part-of-planned-phased-expansion.html https://biospectrumindia.com/news/97/27456/neuland-to-open-commercial-peptide-facility-as-part-of-planned-phased-expansion.html Mon, 09 Mar 2026 00:00:00 +0530 Neuland Laboratories  will open its new commercial peptide facility in the summer of 2026 at its 17-acre Bonthapally manufacturing campus in Telangana, with further capacity expansions planned as client demand increases.  The first of four planned modules is expected to be operational by the summer of this year, adding commercial-scale capabilities to Neuland’s existing clinical stage S-Block facilities. Module one has secured firm commitments of approximately $30 million.  Once open, Module One will provide 6,370 L of SPPS [solid phase peptide synthesis] and LPPS [liquid phase peptide synthesis] reactor capacity – for sizes of 250 L to 3000 L in LPPS, as well as SPPS reactors up to the 500 L scale.  Construction of the facility began last year and will enable client execution from small‑scale to multi‑ton commercial volumes, while also providing the flexibility needed for complex and long‑chain peptide programmes. With GLP-1 manufacturing consuming a growing share of global peptide capacity, Neuland is targeting innovator and emerging biotech programs facing tightening access to clinical and commercial manufacturing across a broad range of indications. R&D headcount is also expected to grow at a double‑digit rate this year, and the manufacturing team will more than double to support the ramp‑up. This complements Neuland’s existing 1,174,000 L of API manufacturing capacity across three US FDA–approved facilities, which are supported by a large, dedicated R&D Centre located in close proximity. This integrated setup enables seamless scale‑up, rapid tech transfer, and highly efficient development-to-commercial execution. The newly completed plants will feature advanced digital operation systems – controlled through DCS-based automation with eBMR integration – and scalable peptide technologies across synthesis, purification and drying. The facility includes expanded downstream capabilities: multi‑column prep‑HPLC systems, lyophilisers and dryers sized for commercial campaigns, enhanced solvent‑handling and tank‑farm infrastructure, dedicated warehouses, and upgraded waste‑management systems supporting high‑volume operations. The systems are designed to support data-rich process development, reduced batch variability and improved cycle times. ]]> https://biospectrumindia.com/news/97/27433/lonza-selects-hyderabad-as-new-gcc-location.html https://biospectrumindia.com/news/97/27433/lonza-selects-hyderabad-as-new-gcc-location.html Fri, 06 Mar 2026 00:00:00 +0530 Lonza Group AG, a world-leading contract development and manufacturing organisation (CDMO), has announced its decision to establish a new Global Capability Centre (GCC) in Hyderabad. The development further strengthens Telangana’s growing prominence as a global life sciences hub. A delegation from the company met with Minister for Industries & Commerce, D. Sridhar Babu, and CEO of Telangana Lifesciences, Shakthi M. Nagappan, to formally convey the decision and share details of their proposed plans. Headquartered in Switzerland and founded in 1897, Lonza operates across more than 30 sites worldwide and employs close to 20,000 professionals. In 2025, the company reported sales of CHF 6.5 billion and a Core EBITDA of CHF 2.1 billion. The decision follows an extensive evaluation process from which Hyderabad was identified as a preferred destination based on its strong talent pool, quality infrastructure, and supportive industrial ecosystem. Over the past several months, senior representatives of Lonza have engaged with Telangana Lifesciences, the Industries & Commerce Department, and other stakeholders, which further reinforced the company’s confidence in Hyderabad as the right location for this investment. D. Sridhar Babu, Hon’ble Minister for Industries and Commerce, Government of Telangana, said, “Lonza’s investment further strengthens Telangana’s position as a preferred destination for innovation-led growth in the global biopharmaceutical industry. I am delighted that the centre has the potential to create a substantial number of new jobs over the years. We remain committed to supporting such endeavours that promise job creation for our citizens.” Shakthi M. Nagappan, CEO, Telangana Lifesciences, said, “We are delighted that Lonza has chosen Hyderabad for this expansion. This decision marks another significant milestone in the continued expansion of Telangana’s life sciences ecosystem. We look forward to working closely with Lonza to ensure the successful execution of this project and to enable long-term value creation.” The new GCC is expected to contribute to the generation of high-value employment and further integrate Hyderabad into the global biopharmaceutical value chain.   ]]> https://biospectrumindia.com/features/97/27404/can-indias-cdmos-lead-the-next-biopharma-wave.html https://biospectrumindia.com/features/97/27404/can-indias-cdmos-lead-the-next-biopharma-wave.html Sun, 01 Mar 2026 00:00:00 +0530 India’s CDMO industry accounts for 2–3 per cent of a global market valued at over $140 billion in 2024 noted BCG report. Growth has been supported by established small molecule capabilities, faster project initiation timelines, focus on quality systems, and cost competitiveness. India also has more than 650 US Food and Drug Administration (FDA)-compliant pharmaceutical plants, one of the highest counts outside the United States. While small molecules represented 68.23 per cent of the India contract manufacturing organisation market in 2024, the demand is gradually shifting. New modalities such as peptides, biologics, and other advanced therapies are gaining share in global pipelines. Biologics contracts, in particular, are accelerating, with a projected CAGR of 15.79 per cent, which could lift their share to well above 30 per cent by the end of the decade according to the Mordor Intelligence report. In response, Indian CDMOs are entering strategic partnerships, technology collaborations, and co-development agreements to expand capabilities and participate in higher-complexity segments.   From Small Molecules to Specialised Therapies As the industry shifts beyond its traditional small molecule base, efforts are underway to reposition India’s CDMO ecosystem for more complex and innovation-driven segments. In 2024, eight Indian CDMOs announced that they had formed a trade group to raise the profile of India’s drug services sector and position the country as a destination of choice. In 2025, amid concerns over the lack of a clear and unified industry definition and slow structural progress, leaders came together to form the Innovative Pharmaceutical Services Organisation (IPSO). As a dedicated industry body uniting 11 leading CRDMO companies, IPSO aims to create a strategic blueprint and roadmap to define the CRDMO sector and accelerate India’s presence in biopharma innovation. Companies are also expanding their capabilities in advanced modalities. Aragen has launched a new cell line development and early manufacturing platform, while Bharat Biotech has introduced Nucelion, a next-generation cell and gene therapy CRDMO. Companies are also opening new facilities both domestically and internationally to expand capacity and strengthen their manufacturing footprint. Eli Lilly has announced over $1 billion in new contract manufacturing investments in India. Jubilant Biosys has opened a new discovery and preclinical facility in Noida, doubling its chemistry capacity for research and scale-up projects. Cohance Lifesciences has injected Rs 23 crore into a cGMP oligonucleotide facility in Hyderabad. Shilpa Medicare has opened a flow chemistry manufacturing centre in Bengaluru, strengthening high-complexity API manufacturing. Indian CDMOs are also scaling their global presence. Akums has broken ground for its first overseas manufacturing facility in Zambia. Hyderabad-based Novopor Advanced Science has expanded internationally through the acquisition of US-based FAR Chemical, strengthening its position in custom and complex specialty chemical manufacturing. Enzene has announced the opening of a new continuous biomanufacturing facility in the US. Cohance Lifesciences has announced a $10 million investment in a cGMP bioconjugation suite in the US. Strategic development and CDMO partnerships are also accelerating such as Sai Life Sciences, Agility Life Sciences, and Centrix Pharma Solutions have launched an Integrated CMC partnership to provide end-to-end Chemistry, Manufacturing and Controls services to innovator biopharma companies.  This expansion into advanced and high-value segments also introduces a new set of challenges for the sector.   Challenges   While India’s CDMO sector continues to expand, industry leaders agree that the challenges confronting the sector can broadly be categorised into four themes: rising complexity of therapies, escalating regulatory and compliance demands, supply chain and geographic risks, and persistent margin pressures amid demand volatility.  Complexity of Therapies and Technology Upgradation “One of the biggest challenges currently facing CDMOs is that even simple ‘small' molecules have become complex. Customer pipelines are no longer dominated by conventional small molecules; instead, there is rising demand for capabilities in peptides, oligonucleotides, antibody–drug conjugates and other advanced modalities. As a consequence of this shift CDMOs have had to advance and invest in deeper process expertise, advanced technologies, and more sophisticated analytical and quality frameworks,” said Saharsh Davuluri, Vice Chairman and Managing Director, Neuland Laboratories. Neuland Laboratories Limited has announced a major investment in a new commercial-scale peptide manufacturing facility at its Bonthapally site. Construction of phases one and two, out of four planned phases, began last year, with the first modules expected to become operational by Q2 FY 2027. The facility is being developed to support both development and commercial programmes, including GLP-1s, amylin analogues, and other peptide-based therapies. “While the Indian CDMO sector has seen substantial growth, it still faces challenges in advanced capabilities like biologics, a high‑value segment where many global players have more advanced infrastructure,” agrees Manish Jain, Director, Naprod Life Sciences.  Regulatory Pressure and Compliance Cost Escalation “CDMOs face several challenges globally, which are also prevalent in the Indian pharmaceutical industry. A significant issue is navigating complex and constantly evolving regulatory requirements from major health authorities, as well as regulators in India. Indian CDMOs, in particular, must manage the added complexity of aligning with both global standards and domestic regulations. This often involves high costs related to maintaining compliance, ensuring bio‑equivalence, and meeting quality standards. Supply chain vulnerabilities are another critical challenge, as CDMOs rely on key raw materials and often face logistical hurdles in importing and distributing these materials. Rising client expectations for more integrated and higher‑complexity services, such as biologics and specialised injectables, have put further pressure on these organisations to upskill and optimise their processes,” said Jain.  Pricing and compliance pressures continue to weigh heavily on the companies. “For formulations under price control, conversion charges and packing charges referenced by the Drug Price Control Orders (DPCO) guidelines have not kept pace with real inflation. Since those benchmarks were set, costs of labour, utilities, transport, compliance, and quality systems have risen sharply. However, National Pharmaceutical Pricing Authority (NPPA)-imposed price ceilings restrict the ability to pass on these increases, creating sustained margin pressure for CDMOs,” said Saurabh Agarwal, Director, HAB Pharma.  Regulatory upgrades are adding to the cost burden in the domestic market. “The updated Schedule M norms require stronger quality systems, improved facility design, enhanced documentation, and additional trained manpower. While these upgrades are essential for patient safety and global alignment, they significantly increase capital and operating expenditure for manufacturers serving price-sensitive domestic markets,” said Agarwal.  International business brings its own set of regulatory pressures. “Many international markets now expect manufacturing standards approaching US FDA or EU Good Manufacturing Practice (GMP) levels. This means heavy investment in infrastructure, data integrity systems, validation, and regulatory documentation. However, pricing expectations in several emerging and regulated markets do not always reflect the true cost of maintaining such high compliance standards,” said Agarwal.  Supply Chain Diversification and Geographic Risk “A second major challenge for CDMOs is the changing geography of outsourcing. Customers are increasingly adopting China-plus-one strategies, alongside growing interest from Western innovators in more local or diversified manufacturing options. So, geographic risk and continuity of supply are now central to sourcing decisions. Therefore, we have been strengthening local sourcing by qualifying reliable Indian suppliers that meet our requirements for quality, reliability and timely delivery. We have also introduced more robust business continuity frameworks to minimise disruptions arising from logistics challenges and geopolitical uncertainty,” said Davuluri. Echoing similar sentiments, Neeraj Sharma, CEO & MD, OneSource Specialty Pharma said, “The CDMO industry is undergoing significant change, driven by global uncertainty, supply chain fragmentation, and growing demand for complex therapies. While regulatory pressures, costs, and capacity constraints remain challenges, they are also prompting pharmaceutical companies to rethink their manufacturing strategies. Increasingly, customers are looking to simplify supply chains and reduce geographic concentration risk by working with partners who can offer integrated, reliable solutions. As companies continue to diversify supply networks and scale critical therapies such as GLP-1s, the importance of dependable, high-quality partners will only grow.”  OneSource, is investing approximately $100 million across drug–device combination products, fill-finish, and assembly, supported by a strong focus on quality, compliance, and consistent execution. “Frequent fluctuations in API, excipient, and packaging material prices make cost planning difficult, especially when finished product prices are regulated,” said Agarwal. The volatility is closely linked to global sourcing dynamics. “API pricing and availability are heavily influenced by global supply chains, particularly India–China trade dynamics. Any disruption quickly impacts cost structures and timelines,” said Agarwal. Packaging inputs add another layer of challenge. “Packaging material volatility - Key packaging inputs such as aluminium and PVC, which are critical for blister and strip formats, have seen sharp and unpredictable price swings. This adds further uncertainty to long-term contract manufacturing agreements,” said Agarwal. Navigating Market Volatility While the Indian CDMO sector has seen substantial growth, it still faces volatility and uncertainty. “Indian companies must also manage the risk of fluctuating demand for their services. Companies are investing in infrastructure, but sometimes face challenges in balancing long‑term capital expenditures with current demand. The overall global biopharma market slowdown and regional challenges further add to the volatility and uncertainties faced by CDMOs,” said Jain.    Filling the gaps  To tackle these challenges, CDMOs have taken several strategic and operational measures to strengthen their competitiveness and resilience. “CDMOs are responding through a mix of operational discipline and strategic realignment: Stronger cost engineering and efficiency programmes to offset margin pressures without compromising GMP standards; Early client engagement and transparent costing models to align expectations on compliance-driven investments; Diversified vendor bases and strategic sourcing to reduce raw material and packaging volatility risks; Digital quality and documentation systems to improve compliance efficiency under stricter regulatory frameworks; Long-term partnerships instead of transactional contracts, enabling better demand visibility and shared risk planning,” said Agarwal. In terms of growth strategies, CDMOs are increasingly moving toward offering ‘end‑to‑end’ services. “This means combining drug formulation, analytical support, and regulatory assistance along with manufacturing, allowing them to reduce development timelines and strengthen client relationships. Indian CDMOs are also focusing on advanced technologies like biocatalysis, continuous manufacturing, and biologics production to keep up with global demand for high‑complexity drugs. To address talent gaps, companies are investing in talent development programmes, cross‑department collaboration, and forming partnerships with academic and research institutions. These solutions are helping Indian CDMOs stay competitive, increase operational efficiency, and better meet the evolving demands of the global pharmaceutical industry,” said Jain. To tackle regulatory and compliance complexities, CDMOs are enhancing their quality management systems and adopting automated tools to streamline processes, documentation, and ensure faster alignment with regulations. “Many companies are also engaging with industry bodies and government officials to advocate for smoother approval processes and infrastructure support, which will help reduce delays and costs. On the supply chain front, CDMOs are diversifying their sources for raw materials and implementing predictive tools to better anticipate supply disruptions and manage inventories more efficiently,” said Jain. Companies are also  taking steps to strengthen and reduce operational risk. “Therefore, we have been strengthening local sourcing by qualifying reliable Indian suppliers that meet our requirements for quality, reliability and timely delivery. We have also introduced more robust business continuity frameworks to minimise disruptions arising from logistics challenges and geopolitical uncertainty,” said Davuluri. An EY report outlines a three-pronged strategy to unlock India’s projected $450 billion pharmaceutical potential. First, it calls for greater regulatory agility and policy leadership by aligning Indian GMP standards with global benchmarks, strengthening participation in international regulatory forums, and creating a CRDMO-specific regulatory pathway supported by Regulatory Data Protection to enable early-phase trials and co-development. Second, the report emphasizes the need for stronger R&D investment and innovation financing, including public–private funds to support high-risk research in biologics, cell, and gene therapies. It also urges pharmaceutical companies to raise R&D spending beyond 10 per cent of revenues and establish co-innovation laboratories with academia and startups to bridge the gap between discovery and commercialisation. Third, it highlights talent and capability development as critical, recommending modernisation of academic curricula to include AI, machine learning, bioinformatics, and regulatory science, along with structured collaboration between industry, CRDMOs, and global capability centers to create job-ready programmes and link research grants to measurable outcomes such as IND filings. India is laying the groundwork to be ready for the next wave of manufacturing at scale, as a primary supplier of some of the most innovative commercial therapies. The challenges span regulatory complexity to supply chain disruptions and rising expectations in advanced modalities. How the industry continues to address these pressures will shape its transition from a cost-driven outsourcing base to a globally trusted manufacturing and innovation partner. BCG estimates that the Indian CDMO market is projected to grow from $7 billion to $14 billion by 2028, capturing 4 to 5 per cent of the global market; the coming years will be critical in determining whether scale translates into sustained global leadership.   Ayesha Siddiqui ]]> https://biospectrumindia.com/news/97/27388/steincares-and-shilpa-biologicals-to-expand-access-to-biosimilars-across-latin-america.html https://biospectrumindia.com/news/97/27388/steincares-and-shilpa-biologicals-to-expand-access-to-biosimilars-across-latin-america.html Wed, 25 Feb 2026 00:00:00 +0530 SteinCares, a leading specialty healthcare company in Latin America, and Karnataka-based Shilpa Biologicals (SB), a fully integrated biopharmaceutical subsidiary of Shilpa Medicare, have announced a strategic licensing agreement to commercialize a biosimilar across Latin America. Under the agreement, SteinCares will hold exclusive rights to register, commercialise, and distribute biosimilar across the region while SB will complete product development and commercial manufacturing from its facility in Dharwad. The partnership brings together SB's expertise in biologics development and high-quality commercial manufacturing with SteinCares' integrated regional platform. Mitchell Waserstein, CEO, SteinCares said, "This agreement reinforces our leadership in biosimilars and our role as a strategic partner for global biopharmaceutical companies seeking to enter Latin America's complex healthcare markets. By combining Shilpa's proven capabilities in biologics development and manufacturing with our integrated regional platform and deep market expertise, we are creating scalable healthcare opportunities and expanding access to innovative, cost-effective treatments across the region." "SteinCares is a trusted partner in Latin America with proven expertise in the registration and commercialization of specialty therapies," said Dr Sridevi Khambhampaty, CEO, Shilpa Biologicals. "Through this licensing agreement, we are entering Latin America and aim to broaden patient access to safe treatments across the region. We believe this collaboration will create meaningful value for patients, healthcare systems, and our organizations as we expand our biosimilars footprint in Latin America. This collaboration reinforces our commitment to scalable, long-term global licensing partnerships and creates a strong platform for future collaborations across key international markets and our growing biosimilars portfolio." ]]> https://biospectrumindia.com/news/97/27372/morepen-labs-bags-rs-825-cr-deal-for-expansion-into-cdmo-segment.html https://biospectrumindia.com/news/97/27372/morepen-labs-bags-rs-825-cr-deal-for-expansion-into-cdmo-segment.html Mon, 23 Feb 2026 00:00:00 +0530 Morepen Laboratories has secured a multi-year Contract Development and Manufacturing Organization (CDMO) mandate valued at approximately Rs 825 crore ($91 million) from a leading global pharma major. Supplies under the mandate are expected to commence within the next 4–5 months, with execution scheduled through Q1 of the following financial year, subject to customary operational and regulatory processes. This engagement marks one of the most significant single CDMO mandates in the company’s history, as it scales its global manufacturing footprint. Built on over four decades of API manufacturing expertise and regulatory credibility, Morepen’s CDMO platform enables deeper collaboration with global pharmaceutical innovators through structured, multi-year supply programs. The mandate reflects the Company’s growing capabilities in regulated markets, supported by internationally accredited facilities including USFDA, WHO-GMP, and EU approvals. With integrated development-to-commercial manufacturing capabilities, Morepen is positioned to support complex scale-ups and long-duration supply frameworks. Sushil Suri, Chairman & Managing Director, Morepen Labs said “This mandate represents an important milestone in the evolution of Morepen’s manufacturing platform. It reflects the confidence global customers place in our quality systems, regulatory track record, and execution capabilities. Over the years, we have steadily strengthened our infrastructure and compliance depth, enabling participation in larger, long-duration global programmes.” Global pharmaceutical companies are increasingly consolidating supplier networks and partnering with compliant, scalable, and reliable manufacturing platforms capable of long-term supply continuity. Morepen’s vertically integrated API capabilities, regulatory track record, and operational scale position it well to serve this evolving demand ]]> https://biospectrumindia.com/news/97/27362/sai-life-sciences-to-recruit-700-professionals-in-fy27.html https://biospectrumindia.com/news/97/27362/sai-life-sciences-to-recruit-700-professionals-in-fy27.html Sat, 21 Feb 2026 00:00:00 +0530 Hyderabad-based Sai Life Sciences, one of India’s leading integrated contract research, development and manufacturing organizations (CRDMOs), has announced plans to hire 700+ scientific, technical, and management professionals during 2026–27 as it scales capabilities to meet growing global demand for end-to-end drug discovery, development and manufacturing services. The recruitment will span roles across medicinal chemistry, biology, DMPK, process and analytical development, formulation development, process engineering, technology transfer, quality, peptides, business development, program management, and manufacturing, among others. A specific area of focus through this recruitment drive will be on attracting high-calibre scientists from leading institutions in India and globally, reflecting the increasing complexity of programs being entrusted to Sai Life Sciences and the higher scientific expectations placed on Indian CRDMOs by global innovator companies. The new roles will support growing activity in areas such as complex small-molecule synthesis, high-throughput experimentation, data-enabled drug discovery, and late-stage CMC and commercial manufacturing scale-up. As part of its talent strategy, Sai Life Sciences has launched a global alumni engagement platform and is strengthening learning, leadership development, and internal mobility programs to support long-term career growth. ]]> https://biospectrumindia.com/news/97/27341/illuminate-3-0-witnesses-formation-of-first-of-its-kind-consortium-for-clinical-trials.html https://biospectrumindia.com/news/97/27341/illuminate-3-0-witnesses-formation-of-first-of-its-kind-consortium-for-clinical-trials.html Tue, 17 Feb 2026 00:00:00 +0530 In a strong response to promote advocacy towards cancer awareness and cutting-edge cancer treatment in India, a group of renowned oncologists signed on the dotted line to conceptualise a consortium with the goal of promoting a clinical trials network in the country. The signing took place at Illuminate 3.0 – a 3-day oncology townhall hosted by Dr Sewanti Limaye who was the Organising President and the Convener of the meeting. The clinical trial alliance was championed by Dr Sewanti Limaye with Dr Kumar Prabhash as Chair, and Dr Shona Nag and Dr Atul Batra as Vice Chairs. The consortium will facilitate shaping up the infrastructure to strengthen cancer care trials in India. Prior to the signing, the forum was enriched with insightful discussions underlining the need for a collaborative clinical trials network in India, era-adaptive trials, and common pitfalls. The event also strengthened its cancer screening mission with the active involvement of Dr Abhishek Shankar from AIIMS, New Delhi, who contributed significantly to advancing scalable cancer screening strategies in India. The platform witnessed the launch of the 2nd edition of the Gastric Cancer Book – a compilation comprising evidence-based diagnosis and treatment in which Dr Sewanti Limaye herself and her team have been prime contributors. In addition to this, amid the presence of globally renowned oncologists, Roche Pharma India unveiled Tecentriq®️ (atezolizumab) Subcutaneous (SC). A significant step towards enhancing cancer-care delivery, the subcutaneous formulation provides an alternative route of administration designed to maintain clinical effectiveness while simplifying the treatment experience for both patients and healthcare providers. One of the most prominent events at Illuminat 3.0 was the launch of the “Liquid Biopsy Foundation of India”. Through this initiative, clinician scientists like Dr Sewanti Limaye and molecular scientist like Dr Prashant Kumar, come together to bring discussions around blood test for cancer detection and also for treatment response tracking, to the center of discussion. Dr Sewanti Limaye, Director – Medical & Precision Oncology, Sir H.N. Reliance Foundation Hospital, said, “Cancer burden both domestically and internationally has spiked multifold, and as per the statistics, India records over 1.4 million new cancer cases every year. What is more concerning is that most of them are detected at advanced stages, making treatment complex, expensive, and outcomes uncertain. Through this initiative and platform, our collective efforts are to make a humble submission to the Indian healthcare ministry to include cancer screening as a part of Ayushman Bharat. We also propose cancer screening and awareness to be mandated as a part of CSR initiatives of Indian corporates, with the sole interest to build an ecosystem that thrives on proactive attention rather than reactive response to detect, treat, and eradicate cancer from society.”     ]]> https://biospectrumindia.com/news/97/27331/iscrs-19th-annual-conference-focuses-on-digital-innovation-shaping-patient-centric-clinical-research-in-india-.html https://biospectrumindia.com/news/97/27331/iscrs-19th-annual-conference-focuses-on-digital-innovation-shaping-patient-centric-clinical-research-in-india-.html Mon, 16 Feb 2026 00:00:00 +0530 The Indian Society for Clinical Research (ISCR), an association of clinical research professionals, recently hosted its 19th Annual Conference in Delhi,  bringing together more than 1900 individuals and 285 eminent speakers to explore how digital innovation, global collaboration and regulatory excellence are shaping the future of patient-centric clinical research in India.  Centered on the theme, “Accelerating Clinical Research in India through Digital Innovation, Global Collaboration and Regulatory Excellence for Patient-Centric Value Creation” the event convened clinical researchers, Indian and Global pharmaceutical, medical diagnostics, R&D companies, research trainees and startups. Industry experts and thought leaders including  Dr Jerin Jose Cherian (Indian Council of Medical Research), Dr Sudeep Gupta (Tata Memorial Centre), Dr Y K Gupta (AIIMS - Jammu and Bhopal), Dr Suman Karanth (Fortis Memorial Research Center), Dr Upendra Kaul (Batra Hospital), Dr Ganesh Dakhale (AIIMS) and Gaurab Chakraborty (Veramed) participated in discussions on emerging trends, evolving regulatory frameworks, and the growing role of digital technologies in clinical research. Additional speakers at the event included representatives from leading companies like Sun Pharma, Pfizer, IQVIA, Dr. Dangs Lab, City Imaging & Clinical Labs, CRNI, Abiogenesis Clinpharm, NOVOTECH, ADVARRA, DiagnoSearch Life Sciences, Thermo Fisher Scientific, Fortis, etc. to name a few. Key sessions focused on global clinical development, operational rigor in clinical research in line with development of clinical trial sites, regulatory efficiencies and harmonization, global collaboration, data integrity, innovation and patient centric research models, highlighting opportunities for India to further strengthen its position as a preferred source of high quality clinical research. Sharing her thoughts about the importance of clinical research in India, President of ISCR, Dr.Seema Pai said, “India’s clinical research ecosystem is undergoing a significant shift driven by rapid advances in digital technologies, data-led research models and a growing focus on patient-centric trial design. Together, these  developments are enabling more efficiency, inclusiveness and scalable clinical research, while also strengthening patient engagement and trust across the research lifecycle.” She also added, “Recent regulatory reforms and policy measures, including continued emphasis on healthcare, innovation, and research in the Union Budget, reflect India’s strong commitment to building a globally aligned and future-ready clinical research environment." The conference concluded with a shared sense of purpose among participants, by emphasising the importance of working together to turn ideas into action. ]]> https://biospectrumindia.com/news/97/27302/syngene-collaborates-with-johns-hopkins-university-to-advance-early-stage-drug-discovery.html https://biospectrumindia.com/news/97/27302/syngene-collaborates-with-johns-hopkins-university-to-advance-early-stage-drug-discovery.html Tue, 10 Feb 2026 00:00:00 +0530 Bengaluru-based Syngene International, a global contract research, development, and manufacturing organization (CRDMO), has announced a strategic collaboration with Johns Hopkins University, MD, U.S., to advance early-stage drug discovery programs and platform technologies emerging from the university’s research labs. The collaboration will be delivered by Syngene SynVent™, a fully integrated drug discovery and development platform that spans discovery biology, medicinal and synthetic chemistry, DMPK (Drug Metabolism and Pharmacokinetics), toxicology, and early development. Syngene’s Connector model, which is designed to bridge high-potential, early-stage assets and technology platforms with strategic investors and downstream partnerships will be leveraged to bring together relevant stakeholders to sponsor research and secure licensing options for the resulting intellectual property. Kenneth Barr, Senior Vice President, Head of Strategic Collaborations, Syngene International, said, “We are uniquely positioned to translate pioneering research into credible therapeutic candidates, and our goal is to significantly compress the time required for high‑potential programs to become clinically relevant, creating a faster and more efficient pipeline of new medicines.” According to Paul Nkansah, Senior Director of Corporate Partnerships at Johns Hopkins Technology Ventures, this novel collaboration model has the potential to link discoveries from Johns Hopkins laboratories with the drug discovery capabilities of Syngene, pharmaceutical and biotech partners, and investors – accelerating groundbreaking innovations developed at Johns Hopkins and turning promising science into credible development programs that could ultimately lead to new options for patients. ]]> https://biospectrumindia.com/news/97/27220/novopor-advanced-science-acquires-far-chemical-expands-us-footprint.html https://biospectrumindia.com/news/97/27220/novopor-advanced-science-acquires-far-chemical-expands-us-footprint.html Thu, 22 Jan 2026 00:00:00 +0530 Hyderabad-based Novopor Advanced Science, a Bain Capital portfolio company and global performance chemicals and material science CDMO, has announced the acquisition of FAR Chemical, a US-based leader in custom and complex specialty chemical manufacturing focused on Electronics, Aerospace & Defense, Coatings & Adhesives and other Specialty Chemicals, from its US parent CPS Performance Materials Group. The acquisition of FAR Chemical is a key milestone in Novopor’s strategy to build an integrated specialty chemical platform that delivers end-to-end solutions to customers ranging from early-stage process development to commercial scale manufacturing. Integrating FAR Chemical’s deep expertise in complex chemistries and attractive end markets complements Novopor’s existing capabilities and expands its US presence.   Novopor Advanced Science, backed by Bain Capital, has been executing a strategy of targeted investments and acquisitions to expand its global footprint and technical portfolio. In 2025, Novopor acquired Pressure Chemical Company, a Pittsburgh-based specialty chemical and high-pressure chemistry expert, broadening its development-to-manufacturing capabilities and reinforcing its presence in the US market. Additionally, Novopor inaugurated a state-of-the-art Pilot Plant Facility in Visakhapatnam, designed to bridge early-stage R&D with commercial-scale production and accelerate innovation across agrochemicals, performance materials, and specialty chemicals. ]]> https://biospectrumindia.com/news/97/27198/hrv-pharma-and-haleos-labs-forge-strategic-cdmo-alliance-to-fast-track-orphan-drug-niche-api-development.html https://biospectrumindia.com/news/97/27198/hrv-pharma-and-haleos-labs-forge-strategic-cdmo-alliance-to-fast-track-orphan-drug-niche-api-development.html Tue, 20 Jan 2026 00:00:00 +0530 HRV Global Life Sciences (HRV Pharma) has announced a comprehensive, multi-year strategic development partnership with SMS LifeSciences (now Haleos Labs). This exclusive partnership focuses on the development, scale-up and GMP manufacturing of multiple orphan-drug and niche-therapeutic APIs for regulated & semi-regulated markets. The collaboration brings together HRV’s world-wide market access, commercial footprint across 50+ countries, and its digital, asset-light Virtual API platform, with SMS’s deep chemistry capabilities, WHO-GMP aligned manufacturing systems, and proven track record in specialty API production. Under the agreement, both companies will jointly execute: Co-development of a multi-year pipeline of high-value specialty APIs, including orphan, ultra-rare and niche-therapeutic categories End-to-end GMP development and commercial manufacturing — from route scouting and process intensification to scale-up, validation and global supply Integrated global regulatory strategy, including DMF filings across US, EU, LATAM, MENA & APAC supported by complete CMC, stability, validation and technical documentation A forward-looking annual launch program, introducing 5–7 new molecules every year across rare diseases, CNS disorders, metabolic conditions and high-science therapeutic spaces A harmonised quality, compliance and audit-readiness framework, engineered to meet the stringent expectations of USFDA, EMA, PMDA, ANVISA and other regulatory authorities  The partnership has already launched with a structured pipeline of five initial orphan/niche therapeutic programmes, with additional molecules planned each year under a unified annual development framework. Multiple US DMF’s have already been filed by HRV Pharma as a result of fledging partnership between the two organizations. Both organisations will jointly manage CMC documentation, stability studies, validation programmes and global regulatory interactions, creating a seamless development-to-commercialisation pathway. ]]> https://biospectrumindia.com/news/97/27194/syngene-international-extends-long-term-research-collaboration-with-bristol-myers-squibb-until-2035.html https://biospectrumindia.com/news/97/27194/syngene-international-extends-long-term-research-collaboration-with-bristol-myers-squibb-until-2035.html Mon, 19 Jan 2026 00:00:00 +0530 Syngene International, a global contract research, development, and manufacturing organization (CRDMO), has announced the extension of its long-standing strategic collaboration with Bristol Myers Squibb through 2035.  The expanded agreement broadens the scope of integrated services across the drug development lifecycle spanning discovery (chemistry, biology, drug metabolism and pharmacokinetics), translational sciences, pharmaceutical development and manufacturing, clinical trials, data and information technology services to enable seamless progression from research to commercialisation. The expansion of this collaboration marks the next phase of growth, reinforcing Syngene’s position as a strategic partner delivering integrated, end-to-end scientific and manufacturing solutions.  The collaboration between Syngene and Bristol Myers Squibb began in 1998, culminating in the establishment of the Biocon Bristol Myers Squibb Research and Development Center (BBRC), Syngene’s first dedicated R&D Center, which was fully commissioned in 2009.  Over the years, the BBRC has evolved into a major strategic R&D site for Bristol Myers Squibb, supporting integrated capabilities across target identification, lead discovery, lead optimization, pharmaceutical development, molecular and cell biology, protein sciences, assay biology and clinical biomarkers. The center, which today houses around 700 Syngene scientists working as an extension of Bristol Myers Squibb’s global research organization, contributes to discovery, preclinical development, and patent filings across therapeutic areas including cardiovascular, fibrosis, immunology, and oncology. Since its inception, BBRC has played a pivotal role in accelerating the progression of novel compounds from early discovery to first-in-human studies, thereby helping reduce development timelines and overall costs for Bristol Myers Squibb. ]]> https://biospectrumindia.com/news/97/27166/jubilant-biosys-doubles-early-chemistry-scale-up-capacity-with-new-noida-facility.html https://biospectrumindia.com/news/97/27166/jubilant-biosys-doubles-early-chemistry-scale-up-capacity-with-new-noida-facility.html Mon, 12 Jan 2026 00:00:00 +0530 Jubilant Biosys Limited, a wholly owned subsidiary of Jubilant Pharmova Limited, and a global CRDMO operating from five sites across India and Europe, has announced the opening of a new discovery and preclinical facility at Noida, doubling its overall chemistry capacity for discovery research and scale-up projects.  The multimillion-dollar facility combines discovery and early-phase scale-up capabilities with R&D labs and two pilot plants, meeting growing demand in particular for fee-for-service (FFS) contracts.  “We have grown rapidly over the past year, well above the wider market, by expanding our FFS offerings, which enable innovators to advance discovery projects with lower risk. With improving funding conditions, we anticipate even higher demand next year, and this new facility doubles our existing capabilities. From a client perspective, we can now provide faster discovery delivery and integrated scale-up, with projects seamlessly transferred to our GMP facilities ready for any IND filing and commercial phases” commented Giuliano Perfetti, CEO - Jubilant Biosys Limited.   The new Noida facility offers biotech and pharma partners a fully unified route from discovery to scale-up, augmenting the company’s existing Chemistry Research Innovation Centre (CRIC) in Greater Noida. Collectively, this brings the total numbers of scientists across the business to more than 1300, with the new facility adding multiple manufacturing lines and having already onboarded several new clients.  Designed to handle quantities from hundreds of grams up to 25 kg, the new small-molecule hub combines two pilot plant blocks with co-located discovery labs. It features 20,000 sqft of state-of-the-art R&D space as well as 15 reactors spanning a variety of sizes from 20L through to 250L. Significantly, the facility has been designed with a potential to be expanded multifold in future and has room to quadruple capacity as client demand grows. ]]> https://biospectrumindia.com/news/97/27162/aragen-launches-new-cell-line-development-and-early-manufacturing-platform.html https://biospectrumindia.com/news/97/27162/aragen-launches-new-cell-line-development-and-early-manufacturing-platform.html Sat, 10 Jan 2026 00:00:00 +0530 Aragen has announced the launch of CHOMax™, a new cell line development and early manufacturing platform that supports an integrated path from DNA to IND-enabling clinical supply in ~10 months for suitable standard IgG monoclonal antibodies. This accelerated, royalty-free approach provides biotech and pharma partners with a clearly structured development pathway, including both drug substance and drug product support. CHOMaxTM – which has been refined across 200+ CHO programmes – integrates cell line development, process development, analytics, and GMP manufacturing under quality processes designed to meet global regulatory expectations including FDA, EMA and PMDA. Crucially, key CMC activities can run in parallel where appropriate, reducing avoidable rework risk and timeline uncertainty.  Client programmes using CHOMaxTM follow platform-defined workflows and phase-appropriate practices across the development lifecycle. Speed is driven by early process development starting from pools, in-house Master Cell Bank (MCB) creation, early developability assessment, and parallel GMP readiness planning.  Typical integrated CHOMax™ programmes include generation of a clonal research cell bank (RCB) in ~16 weeks, with stage gates for vector design, transfection, pool screening, single-cell cloning and clone characterization. Once lead clones are identified, phase-appropriate process development, analytical method development and GMP campaign planning run in parallel, guided by pre-agreed decision points. Analytical development, method qualification and Master Cell Bank (MCB) creation are executed within Aragen’s biologics network. GMP drug substance manufacturing is performed under quality processes designed to meet global regulatory expectations, with drug product support for first-in-human dosing provided through qualified partners. ]]> https://biospectrumindia.com/news/97/27059/lupin-manufacturing-solutions-and-polypeptide-announce-strategic-alliance-to-scale-global-peptide-supply-chain.html https://biospectrumindia.com/news/97/27059/lupin-manufacturing-solutions-and-polypeptide-announce-strategic-alliance-to-scale-global-peptide-supply-chain.html Fri, 12 Dec 2025 00:00:00 +0530 Lupin Manufacturing Solutions (LMS), a subsidiary of global pharma major Lupin Limited, has announced a long-term strategic alliance with PolyPeptide Group AG, a specialised, global CDMO for peptide-based active pharmaceutical ingredients. This collaboration aims to enhance supply chain resilience, improve operational efficiency, and accelerate readiness for the rapidly expanding global peptides market. It also advances next-generation peptide therapeutics, including those for metabolics, supporting the long-term strategic growth of both organisations. As part of the alliance, both companies will work towards expanding sourcing options and fortifying peptide supply chains to meet rising global demand for peptide APIs, including for metabolic disease therapies; integrating procurement and supply planning; and ensuring unwavering quality and reliability and delivering superior service globally This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets, while enhancing PolyPeptide’s position as a trusted CDMO partner. Dr Abdelaziz Toumi, Chief Executive Officer, Lupin Manufacturing Solutions, said, “As peptide-based therapies continue to transform the treatment landscape for metabolic and other chronic conditions, LMS is committed to ensuring reliable access to specialised materials that support large-scale commercial production. This underscores our mission to establish secure, agile, and future-ready supply pathways for innovators worldwide.” "Reliability is a competitive advantage in our industry. Working with Lupin Manufacturing Solutions gives us the flexibility and supply chain depth needed to support growing customer demand, including preparations for large-scale metabolics,” said Stéphane Varray, Chief Commercial Officer, PolyPeptide.  ]]> https://biospectrumindia.com/news/97/27020/cytiva-and-veeda-lifesciences-drive-biopharma-innovation-with-new-host-cell-protein-services-centre-in-bengaluru.html https://biospectrumindia.com/news/97/27020/cytiva-and-veeda-lifesciences-drive-biopharma-innovation-with-new-host-cell-protein-services-centre-in-bengaluru.html Mon, 01 Dec 2025 00:00:00 +0530 Cytiva, a Danaher company and a leader in the life sciences industry, is collaborating with Veeda Lifesciences (Veeda Clinical Research Limited), a global contract research organisation, to establish a dedicated Host Cell Protein (HCP) Services Center in Bengaluru, India.   Focused on impurity analysis and HCP testing, this new centre will help biopharmaceutical companies reduce development risks and meet regulatory standards for novel biologics and biosimilars.   Dr Mahesh Bhalgat, Group CEO and Managing Director, Veeda Lifesciences (Veeda Clinical Research Limited), said, “We are delighted to partner with Cytiva to bring deeper scientific insights to biologics manufacturers and enable more robust characterization of biopharmaceutical products. Analytical data is central to product approvals, and our collaboration strengthens the foundation of regulatory approvals of biosimilars.”   Supported by Cytiva’s technology and located within Veeda’s facility, the center will serve as a comprehensive analytical hub for manufacturers, researchers, and academic institutions. Using multiple attribute DIGE (differential gel electrophoresis) techniques, it will streamline workflows and enhance speed and accuracy of analysis. The centre will generate regulatory-ready data for impurity analysis across recombinant proteins, therapeutic monoclonal antibodies, vaccines, and related modalities. Key services include HCP coverage, characterisation and quantification assays, essential for detecting impurities that could compromise product quality and patient safety.   This commitment to quality reinforces insights from Cytiva's 2025 Biopharma Index, which highlights growing demand for analytical and digital tools that improve assurance, regulatory review, and process control, helping companies scale production, reduce batch failures, and deliver critical medicines faster.   Manoj Kumar R Panicker, General Manager of South Asia, Cytiva, said, "This new center is a bold step toward accelerating innovation and advancing therapeutics. It represents what's possible when science, industry, and purpose unite to shape the future of biopharma excellence."   Host cell proteins are process-related impurities from the cells used to manufacture biologics. Even at trace levels, HCP residues can cause toxicity, immune reactions, and affect drug stability. Through this collaboration, the center will use advanced analytical methods combining ELISA and mass spectrometry to help companies assess process effectiveness and ensure quality. ]]> https://biospectrumindia.com/news/97/26951/instapill-partners-with-ach-to-expand-access-to-advanced-oral-dispersing-tablet-solutions-across-latin-america.html https://biospectrumindia.com/news/97/26951/instapill-partners-with-ach-to-expand-access-to-advanced-oral-dispersing-tablet-solutions-across-latin-america.html Wed, 19 Nov 2025 00:00:00 +0530 Bengaluru-based InstaPill has announced its strategic partnership with Brazil-based Aché Laboratórios Farmacêuticos S.A. to co-develop the first of several prescription pharmaceutical products using InstaPill’s proprietary lyophilised oral dispersing tablet (ODT) platform for the Brazilian and other Latin American markets. Commenting on the partnership, Ankit Gupta, CEO of InstaPill, stated, “We are extremely pleased with our maiden partnership with Aché, which pairs InstaPill’s core technical capabilities in oral lyophilisates with Aché’s leading go-to-market expertise. This represents a significant step forward in our mission to expand InstaPill’s unique technology throughout Latin America.” InstaPill is a globally recognised CDMO specialising in orally disintegrating tablets using its proprietary InstaPill® technology platform. A leader in the prescription market in Brazil, Aché's portfolio also includes solutions in generic medicines and over-the-counter (OTC) products. ]]> https://biospectrumindia.com/news/97/26945/hrv-pharma-and-metrochem-forge-strategic-cdmo-alliance.html https://biospectrumindia.com/news/97/26945/hrv-pharma-and-metrochem-forge-strategic-cdmo-alliance.html Tue, 18 Nov 2025 00:00:00 +0530 Hyderabad-based HRV Global Life Sciences (HRV Pharma), India’s first integrated Virtual API and Pharmtech company, has announced a unique, comprehensive, multi-year Contract Development & Manufacturing (CDMO) partnership with MetroChem API, one of India’s leading API development and manufacturing companies.   This unique & first of its kind partnership focuses on the exclusive and semi-exclusive development, scale-up, and GMP manufacturing of multiple high-value NCE-1 and late-stage complex APIs for regulated & semi-regulated markets.   The collaboration brings together HRV’s global market access, commercial footprint across 50+ countries, and its digital, asset-light Virtual API platform with MetroChem’s deep process chemistry, scale-up capabilities, and robust GMP infrastructure.   Under the agreement, both companies will jointly execute: Development and scale-up of multiple strategic APIs, including late-stage NCE-1 opportunities End-to-end GMP manufacturing, validation, and supply for regulated and semi-regulated markets Global regulatory DMF filings (US, EU, LATAM, MENA & APAC) with shared technical dossiers A long-term, pipeline-led framework covering novel CNS, metabolic and specialty therapeutic APIs A unified quality, compliance and audit readiness program designed for USFDA, EMA, PMDA, ANVISA and other key agencies     The partnership includes a structured pipeline of five initial programmes, with additional molecules planned for development under a unified framework.   Both organisations will jointly manage CMC documentation, stability studies, validation programmes, and global regulatory interactions, creating a seamless development-to-commercialisation pathway.   ]]> https://biospectrumindia.com/news/97/26913/lupin-manufacturing-solutions-unveils-dedicated-oncology-block-at-vizag.html https://biospectrumindia.com/news/97/26913/lupin-manufacturing-solutions-unveils-dedicated-oncology-block-at-vizag.html Wed, 12 Nov 2025 00:00:00 +0530 Lupin Manufacturing Solutions (LMS), a wholly owned subsidiary of global pharma major Lupin Limited, has announced the commissioning of its dedicated Oncology Block at its Vizag facility, Andhra Pradesh. The new high-containment unit significantly enhances LMS’s end-to-end Contract Development and Manufacturing capabilities for High Potent Active Pharmaceutical Ingredients. It will support clients across the oncology development lifecycle from preclinical research to commercial manufacturing, addressing growing global demand for oncology drug development and manufacturing. Spanning 4,270 square meters, the new facility, is equipped with 20 reactors, ranging from 250L to 2000L, with over 20 isolators and advanced containment systems, ensuring exposure levels of ≤0.05 µg/m³. Designed with flexible scale-up capabilities (1–35 kg batch range) and comprehensive environmental controls (≤25°C, ≤45% RH), the facility allows for safe, efficient, and compliant production of oncology APIs that meet global quality standards. The new facility integrates the Process Development Laboratory with a dedicated Quality Control laboratory, enabling early-stage route scouting, analytical development, process optimization, and validation—all in one location. Supported by scientists with specialized HPAPI expertise, it guarantees seamless transition from lab-scale synthesis to full-scale commercial manufacturing. The facility features advanced containment infrastructure, with isolator-based operations at every process step, integrated SCADA systems, and a robust effluent detoxification system that complies with global regulatory standards, while also adhering to Lupin’s stringent quality and environmental safety protocols. With this expansion, LMS strengthens its role as a trusted global CDMO partner for oncology innovators.  ]]> https://biospectrumindia.com/news/97/26866/bharat-biotech-launches-next-gen-cell-and-gene-therapy-crdmo-nucelion.html https://biospectrumindia.com/news/97/26866/bharat-biotech-launches-next-gen-cell-and-gene-therapy-crdmo-nucelion.html Mon, 03 Nov 2025 00:00:00 +0530 Nucelion Therapeutics, a newly established, Hyderabad-based Contract Research Development and Manufacturing Organisation (CRDMO) focused on cell and gene therapies, has announced its formal launch: Nucelion, a wholly owned subsidiary of Bharat Biotech International Ltd. The CRDMO aims to support global life science innovators with high-quality, scalable process development and manufacturing solutions for advanced therapies, indicated for cancers, autoimmune disorders, and rare genetic disorders. The future of pharmaceutical innovation will be biological, with new modalities expected to drive a large share of growth worldwide. Within this shift, cell therapies—autologous, allogeneic, and emerging in vivo approaches—are poised to move from niche programs to scalable platforms, expanding from rare diseases into broader oncology, immunology, and regenerative care as manufacturing, analytics, and delivery technologies mature. Spread across a 30,000 square foot purpose-built facility in Genome Valley, Nucelion has commissioned a GMP facility capable of developing and manufacturing plasmids, viral and non-viral vectors, cell therapies, and aseptic fill & finish, providing end-to-end services for clients. The company will offer end-to-end services, from early-stage clinical development to commercial-scale manufacturing, while adhering to international regulatory standards, including those of the FDA and EMA. Dr Krishna Ella, Non-Executive Director, Nucelion Therapeutics, said, “The future of pharmaceutical innovation will be biological; CGTs are a key vector. Our vision is to integrate advanced therapy platforms into India’s healthcare ecosystem, enabling equitable solutions for complex and rare diseases.” Dr Raghu Malapaka, Chief Business Officer, Nucelion Therapeutics, said, “At Nucelion, we will provide end-to-end solutions from clinical to commercial scale, ensuring regulatory compliance with global standards (FDA, EMA). Nucelion offers services for the development and manufacturing of plasmid DNA, Viral Vectors, Autologous, and Allogeneic Cell Therapies. Nucelion will operate with independent leadership, governance, and information systems, and will engage all sponsors—including Bharat Biotech—on arm’s-length commercial terms.The company’s talent acquisition is underway to onboard scientific and operational talent with global experience in cell and gene therapy execution.   ]]> https://biospectrumindia.com/features/97/26840/cro-reforms-tilting-scale-towards-accelerated-growth-transparency.html https://biospectrumindia.com/features/97/26840/cro-reforms-tilting-scale-towards-accelerated-growth-transparency.html Fri, 31 Oct 2025 00:00:00 +0530 The 2024 New Drugs & Clinical Trials (Amendment) Rules have received strong support from India’s clinical research community, which views them as a pivotal step toward global alignment, efficiency, and greater regulatory clarity. Sanjay Vyas, President and Managing Director of Parexel India, said, “The 2024 reforms have been a welcome step forward for the sector. Beyond compliance, these reforms create opportunities to explore more complex and adaptive trial designs, to leverage digital and AI-driven solutions for patient engagement, and to build greater capacity across sites and teams. In many ways, they enable us to deepen our role in advancing both India’s clinical research capabilities and global drug development efforts.” Over the past five years, Parexel has delivered more than 100 projects in India, supported by a team of over 6,000 professionals. The company’s operations span therapeutic areas including oncology, immunology, respiratory and cardiovascular diseases, infectious diseases, and rare disorders. In June 2025, it became one of the first clinical research organisations (CRO) to complete mandatory registration with the CDSCO. Sharing a similar view, Rama Kondru, CEO of Veridix, said, “The 2024 New Drugs & Clinical Trials Amendments are transforming India’s CRO landscape, setting higher standards for regulatory clarity, operational excellence, and accountability. While the reforms present short-term challenges, they create significant long-term opportunities for CROs to lead globally, manage complex trials, and harness technology and innovation to drive a competitive edge. For Emmes, these reforms provide the clarity and stability required to accelerate growth in India, while reaffirming our commitment to patient safety, ethical compliance, and global standards. We view this regulatory evolution as a catalyst for strengthening our leadership in high-quality clinical research. The trial processes will be streamlined with accelerated approval timelines enabling quicker trial starts and reducing time-to-market for sponsors.” Veridix, part of the Emmes Group, plays a key role in India’s clinical research ecosystem, supporting Phase I to Phase III and post-market studies across multiple therapeutic areas. Emmes India is a strategic hub for the group’s global operations, with expertise in vaccine development and infectious disease research. Shweta Pradhan, Executive Committee Member of the Indian Society for Clinical Research (ISCR), said “The reforms strengthen trust and accountability across the ecosystem. While we do not conduct clinical research ourselves, we closely collaborate with stakeholders including CROs to improve clinical research capabilities, ensure adherence to regulatory compliance, and ensure participant safety. The 2024 NDCT (Amendment) Rules is a progressive step towards regulatory clarity, predictability and efficiency. With respect to CROs, these reforms enable a more streamlined approval process, cut down the time taken for trials to be initiated in the country, also focus on building trust through focus on patient safety and ensure compliance with global standards. This creates a more conducive environment for both global and local sponsors alongside the important stakeholder—the participants of clinical trials in the country.” ISCR represents clinical research professionals from academia, industry, hospitals, and CROs, advocating for ethical, high-quality research that benefits both science and patients. Nagalakshmi Shetty, Vice President, Biometrics and India Country Head at ICON plc, added, “The country’s regulatory landscape is also evolving rapidly. The health authority is taking deliberate steps to streamline and accelerate the approval process for new drugs and clinical trials, improve patient safety protocols, and ensure compliance with global standards. The NDCT Rules, 2024, aim to enhance the clinical trials landscape in India by providing a structured framework for operation of CROs. By aligning more closely with international standards and addressing critical concerns around patient safety and regulatory efficiency, these amendments enhance India’s position as a leading global hub for clinical trials and foster a more transparent, ethical, and credible environment for clinical trials in India.” ICON employs over 4,500 professionals across Chennai, Bengaluru, and Thiruvananthapuram, with remote operations in 18 states. India hosts a major share of ICON’s global workforce, which delivers more than 100 specialised services across clinical trial management and drug development. In the past five years, ICON has conducted trials in 14 therapeutic areas, including oncology, infectious diseases, vaccines, and cardio-metabolic disorders. Dr T Pavan Pradeep, CEO of Actimus Biosciences, highlighted how the reforms improve sponsor confidence and global competitiveness. “The 2024 NDCT (Amendment) Rules represent a significant step forward in aligning India’s clinical research regulations with global best practices. Enhanced clarity on timelines, regulatory pathways for orphan drugs, and provisions for accelerated approvals are likely to benefit the ecosystem by reducing bottlenecks and enabling more efficient trial execution. For CROs like Actimus Bio, these reforms may help streamline approvals, improve sponsor confidence, and expand opportunities in specialised research areas.” Actimus Bio is a full-service, regulatory-compliant CRO based in India that specialises in the design, conduct, and management of clinical trials across multiple therapeutic areas. The company focuses on bioavailability and bioequivalence studies, Phase I to Phase IV trials, and post-marketing surveillance.   Market Impact  The CROs agree that the New Drugs & Clinical Trials (Amendment) Rules, 2024 came at a pivotal moment for India’s clinical research industry. As the country strengthens its position in global drug development, the updated framework is expected to reshape the size, structure, and sophistication of clinical research being conducted. Sharing more details Shweta explained, “We see potential for expansion in more innovative spaces such as rare diseases, oncology, vaccine development, and advanced modalities like cell and gene therapy. The revised framework allows for parallel or accelerated approvals of new drugs, eliminating redundant studies and reducing time and cost inefficiencies. This directly benefits patients by bringing innovative medicines, including those targeting rare diseases, oncology, and emerging therapeutic areas such as cell and gene therapy, to market faster.” India’s clinical research ecosystem is seeing rapid growth in innovative areas such as cell and gene therapies, tri-specific antibodies, etc. While these areas require specialised infrastructure and trained talent, they represent significant new opportunities for CROs. Early-phase research is emerging as a major area of growth under the new regulatory framework. Dr Pradeep Kumar noted, “We anticipate a surge in early-phase trials and greater interest in India as a preferred destination for multi-regional clinical trials (MRCTs). This creates new opportunities for CROs to offer specialised services and partner in complex study designs.” The reforms are also seen as instrumental in diversifying trial formats. Vyas added, “Early-phase trials, including Phase I studies, may expand, while decentralised and technology-driven trials may become more prevalent, supporting improved patient access and data quality. The rules also require CROs to maintain trial records for at least five years, ensuring long-term accountability and integrity of data.” Perhaps the most significant structural change is the mandatory registration of CROs. Shweta highlighted, “The significant update in 2024 was the mandatory registration of all Contract Research Organisations operating in India. This registration aligns with the Indian government’s initiative to bring greater transparency and accountability to the Contract Research Organisations sector. By mandating registration with the CDSCO, the government aims to ensure high-quality, ethically conducted clinical trials that generate reliable data and foster global confidence in India’s research ecosystem.” The reform is expected to create a competitive advantage for compliant players. “Registered CROs will now have a competitive advantage. With compliance, quality standards, and formal registration, CROs can attract global sponsors, expand their service offerings, and participate in more complex, global trials. By formalising CRO oversight and aligning with international Good Clinical Practice (GCP) standards, the rules position India’s credibility as a prime destination for global clinical research,” said Vyas.   Key Challenges and Opportunities for CROs Moving forward, India’s clinical research sector is expected to experience rapid growth but also profound transformation. The new amendments have ushered in a new era of regulatory rigour, formalising the operations of CROs and establishing higher standards of compliance and data integrity. While these changes have opened fresh opportunities, they also present a set of formidable challenges for the industry. “In the next 3–5 years, key challenges for Indian CROs will include navigating increasing complexity in trial protocols, ensuring data integrity and compliance amid rising scrutiny from both domestic and international regulators, and talent acquisition and retention in niche scientific and regulatory roles,” said Dr Pradeep.  As trial designs become more complex and patient-centric, CROs are grappling with operational demands that extend far beyond traditional trial management. “On the other hand, CROs will also face challenges, including maintaining regulatory compliance, ensuring high-quality data, and managing increasingly complex multi-site trials. Operational efficiency and skilled workforce readiness will remain the biggest challenge as trial designs evolve and patient expectations increase. Emerging technology, particularly AI and ML, will fill in the gaps and present adaptable solutions to many of these challenges,” said Vyas. Building a future-ready workforce has become one of the industry’s top priorities. Investment in workforce upskilling is essential. According to Parexel’s recent survey studying the trends impacting the clinical research labor force, one in five biopharmaceutical believe the drug development workforce is well prepared to use AI. Upskilling programmes that focus on critical evaluation, understanding AI limitations, and integrating outputs into decision-making will be key. Workforce development is only one part of a broader structural shift. “Over the next few years, CROs in India will navigate both rapid growth and structural transformation. Key challenges include upskilling employees and investigators, strengthening data quality and completeness, and enhancing digital infrastructure at hospitals to enable seamless adoption of electronic medical records and automated data capture systems. These steps are essential to align with international standards and ensure reliable, globally acceptable research outcomes,” said Shweta. As the country moves toward becoming a hub for large-scale trial execution, the industry faces greater scrutiny and responsibility. “Over the next three to five years, India’s CRO sector will grow rapidly — but with far greater regulatory discipline. Stronger oversight, higher sponsor expectations, and India’s position as a hub for large-scale trial execution will drive more complex studies into the country. At the same time, CROs will face increased pressure to meet stricter standards for compliance, data integrity, and operational readiness,” said Kondru. The new rules make formal registration and audit readiness mandatory, placing a greater burden on smaller players and likely accelerating industry consolidation. Despite these challenges, industry leaders agree that the opportunities ahead are immense. “The sector is also ripe with opportunities: growing demand for decentralised and hybrid trials, increasing biopharma interest in India for cost-effective, high-quality research, and strategic partnerships with global sponsors looking for regional CRO capabilities. Clearer CRO registration and defined responsibilities provide faster trial initiation, and the ability to expand early-phase, decentralized, and complex trials,” said Dr Pradeep.  The overall outlook remains positive, particularly for organisations with strong scientific and operational capabilities.   Technology & Innovation in Clinical Research Technology has become a defining force in reshaping global clinical research, and India is no exception. One of the key features of the New Drugs & Clinical Trials (Amendment) Rules, 2024 is the focus on digital transformation and the integration of advanced technologies across the clinical trial lifecycle. All CROs agree that the adoption of e-clinical platforms, digital recordkeeping, and AI-driven analytics is no longer optional; it has become fundamental to how modern trials are designed, monitored, and executed. “In this new environment, CROs that offer validated e-clinical platforms, centralised monitoring, and AI-driven analytics—from site risk scoring to automated data cleaning—will be positioned to secure premium partnerships. We are uniquely prepared for this shift,” said Kondru. Technology particularly artificial intelligence (AI) and machine learning (ML) is set to play a transformative role by optimising patient recruitment and site selection using real-world data, enhancing safety signal detection and pharmacovigilance, and enabling predictive analytics for trial design and operational efficiency.  “AI and ML allow CROs to process and interpret vast datasets in real time, make faster and more informed decisions as trials progress, and ultimately improve operational efficiency. However, organisations are encouraged to adopt human-in-the-lead AI frameworks, where human oversight guides and critically assesses AI outputs rather than replacing them,” said Vyas. Nagalakshmi emphasises the transformative impact of AI and machine learning on clinical research operations. “AI-driven protocol optimisation uses historical data to create more efficient study designs, while advanced data ingestion frameworks integrate diverse datasets for real-time insights and seamless trial execution. Predictive analytics improve trial planning by forecasting patient recruitment, dropout risks, and outcomes. Automated data capture enhances data integrity by minimising manual errors”, says Nagalakshmi.  She adds, “Risk-Based Quality Management (RBQM) powered by AI proactively identifies and mitigates risks, streamlining compliance and reducing operational burdens. Similarly, Risk-Based Monitoring (RBM) optimises resource allocation by pinpointing high-risk sites. Additionally, AI-driven imaging and diagnostics provide faster, more precise assessments in complex fields like oncology and radiology, redefining the efficiency and accuracy of clinical trials”. Kondru summed up, “Technology will be the key differentiator. AI and machine learning are reshaping trial execution by enabling real-time risk detection, anomaly tracking, and predictive decision-making. At Emmes, we are already integrating Veridix’s AI-based platforms into our operations, delivering higher data accuracy, proactive monitoring, faster study execution, and automating regulatory compliance. By pairing innovation with compliance excellence, we are setting a new benchmark for how clinical research should be run—efficient, reliable, and impactful.”  The New Drugs and Clinical Trials (Amendment) Rules, 2024 represents a pivotal moment in India’s journey toward becoming a global leader in clinical research. Beyond the procedural efficiencies and ethical safeguards, the amendments open the door to transformative business opportunities. By fostering transparency, accountability, and global alignment, the revised rules strengthen India’s appeal as a destination for clinical trials and drug development. The next three to five years will be pivotal as technology and policy converge to redefine the future of clinical development in India.   Ethical concerns In October 2025, two leading contract research organisations (CROs) based in Ahmedabad came under investigation after reports of irregularities in ongoing drug trials. Preliminary findings point to multiple ethical lapses — including recruitment of volunteers through informal agents offering cash incentives, incomplete informed consent procedures, inadequate post-trial follow-up, and data management using non-licensed software. Allegations also mention excessive blood draws and recruitment practices extending across districts. The Ahmedabad Municipal Corporation (AMC) and the Gujarat Food and Drug Control Administration (FDCA) have initiated formal reviews, while the Central Drugs Standard Control Organisation (CDSCO) has been notified. A similar case surfaced earlier in July 2025, when the Karnataka government requested a CDSCO probe into alleged trial violations at a Bengaluru-based hospital group. The complaint was originally raised by the former head of its ethics committee. These incidents have renewed attention on the need for stronger oversight and ethics governance in India’s clinical research sector.    Ayesha Siddiqui ]]> https://biospectrumindia.com/news/97/26855/piramal-pharma-solutions-partners-with-intocell-expanding-payload-linker-platform-and-bioconjugate-capabilities.html https://biospectrumindia.com/news/97/26855/piramal-pharma-solutions-partners-with-intocell-expanding-payload-linker-platform-and-bioconjugate-capabilities.html Thu, 30 Oct 2025 00:00:00 +0530 Mumbai-based Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO), has signed a Memorandum of Understanding (MoU) to solidify its strategic partnership and explore potential collaboration opportunities in ADC development with IntoCell Inc., a leading Korean biotechnology company specialising in innovative antibody-drug conjugate (ADC) linker and payload platform technologies. Pursuant to this non-exclusive and non-binding agreement, IntoCell will explore licensing opportunities for its proprietary drug-linker technologies with Piramal's clients. In exchange, Piramal will offer comprehensive contract research, development, and manufacturing of bioconjugates, including ADCs, to IntoCell and its client base. This partnership enhances Piramal's robust, existing payload-linker and bioconjugation capabilities. Through this agreement, Piramal can now offer clients a broader range of payload-linkers, and faster bioconjugate development times, thereby improving its service offerings and competitiveness in this specialised field. The licensing agreement centers on IntoCell's proprietary drug-linker technologies, including its OHPAS linker, Duocarmycin based OHPAS-payload, Nexatecan based OHPAS-payload, and iso-Nexatecan based GGFG-payload. Additionally, this agreement strengthens ADCelerate™, Piramal's rapid, integrated approach to bioconjugate development and manufacture. Utilising IntoCell's existing resources allows Piramal to further streamline the path from concept to clinic. ]]> https://biospectrumindia.com/news/97/26856/shilpa-medicare-opens-flow-chemistry-manufacturing-centre-in-bengaluru.html https://biospectrumindia.com/news/97/26856/shilpa-medicare-opens-flow-chemistry-manufacturing-centre-in-bengaluru.html Thu, 30 Oct 2025 00:00:00 +0530 Shilpa Medicare, a full-service contract development and manufacturing organization (CDMO), has announced the launch of its new flow chemistry Centre of Excellence (CoE) at CPHI Frankfurt. Based at the CDMO’s Bengaluru site, the Centre unites cross-functional teams across R&D and manufacturing to accelerate process development, scale-up, and commercial production for continuous flow. The new CoE is staffed by a team of more than 100 specialists and integrates Sravathi’s proprietary flow technologies with Sravathi’s advanced continuous reactor platforms, enabling the development and commercialisation of an expanded range of reactions including fluorination, bromination, nitration, chlorination, oxidation, and Grignard reactions. Sravathi’s flow chemistry group has already developed over 30 flow-based reactions, successfully transferring more than five pilot-scale processes to client sites for commercial manufacture.  In terms of reactors the site features more than 50 patented, custom-designed micro and pilot flow reactors, with lab, bench, and pilot scales ranging from 30 mL/min to 200 mL/min. These systems handle multi-phase, catalytic, and gas–liquid reactions under corrosion-resistant materials of construction, ensuring safety and reliability across highly exothermic or hazardous chemistries. Continuous downstream operations —such as crystallization, extraction, and thin-film evaporation — allow fully integrated end-to-end processing. Designed at Sravathi, the reactors have shown consistent and reliable scale-up from laboratory to commercial operations for processes involving gas–liquid and liquid–liquid reactions. By integrating scalability considerations into the design, the time-to-market and risks commonly associated with scale-up have been notably reduced. The centre includes automated processes for temperature and pressure measurements, meaning monitoring and adjustments can be done remotely. This high degree of digitalization ensures reproducibility and scalability while minimizing human intervention during flow operation.   ]]> https://biospectrumindia.com/news/97/26845/akums-breaks-ground-for-first-overseas-manufacturing-facility-in-zambia.html https://biospectrumindia.com/news/97/26845/akums-breaks-ground-for-first-overseas-manufacturing-facility-in-zambia.html Tue, 28 Oct 2025 00:00:00 +0530 Akums Drugs & Pharmaceuticals, Delhi-based Contract Development and Manufacturing Organization (CDMO), has announced a landmark milestone in its global journey, the groundbreaking ceremony of its first overseas manufacturing facility in Zambia.The event marks the beginning of a transformative partnership between Akums and the Government of the Republic of Zambia (GRZ), symbolising a shared vision to make high-quality, affordable medicines accessible to millions across Africa. This initiative represents a major step forward in Akums’ global expansion strategy, reinforcing the company’s mission to deliver healthcare excellence, strengthen exports, and create sustainable pharmaceutical ecosystems in emerging regions.The upcoming facility, to be located in the capital city of Lusaka at the Lusaka South Multi-Facility Economic Zone, will be constructed on approximately 40 acres of land. It will produce a comprehensive range of dosage forms including tablets, hard gelatin capsules, liquids, injectables, topicals, and beta-lactam products, addressing the growing demand for essential and life-saving medicines in Zambia and neighboring countries. The project is also expected to create over 1,000 new employment opportunities, contributing significantly to local economic growth.The Zambia Pharmaceutical Manufacturing Facility, developed in partnership with Akums, will be the nation’s first large-scale pharmaceutical production unit, capable of manufacturing multiple dosage forms across a range of therapeutic areas.   ]]> https://biospectrumindia.com/news/97/26836/sai-life-sciences-to-double-process-rd-capacity-with-new-facility-in-hyderabad.html https://biospectrumindia.com/news/97/26836/sai-life-sciences-to-double-process-rd-capacity-with-new-facility-in-hyderabad.html Mon, 27 Oct 2025 00:00:00 +0530 Sai Life Sciences, one of India’s fastest growing Contract Research, Development, and Manufacturing Organizations (CRDMO), has announced the groundbreaking for a new CMC Process R&D Center at its integrated R&D campus in Hyderabad. Scheduled for completion by September 2026, the facility will double the company’s Process R&D capacity, while adding new capabilities in peptide development, oligo intermediates & linkers development, formulation development and early phase clinical supplies. The new CMC Process R&D Center represents a strategic investment in scale, sustainability, and specialisation. Designed to support both Full-Time Equivalent (FTE) and Dedicated Project Capacity (DPC) engagement models, it will enable flexible collaboration with global innovators—from early development to late-stage CMC programmes. This model further strengthens Sai Life Sciences’ position as a preferred partner for integrated drug development, aligned with the growing demand for end-to-end, partnership-driven solutions that deliver on both quality and timelines. Highlights of the upcoming Process R&D Block include- Total built-up area of 100,000 sq. ft. (9300 sq.m.) over five floors; 140 process chemistry fume hoods with an integrated satellite analytical lab; Dedicated laboratories for peptides and oligo intermediates & linkers; 25,000 sq. ft. centralised analytical laboratory; NCE formulation development and early-phase clinical supply capabilities; Kilo lab for early clinical manufacturing; Containment down to OEL 4 (1 µg/m³); Designed as a ‘Green Building’. ]]> https://biospectrumindia.com/news/97/26825/syngene-announces-plans-to-add-bioconjugation-suite-for-end-to-end-adc-development.html https://biospectrumindia.com/news/97/26825/syngene-announces-plans-to-add-bioconjugation-suite-for-end-to-end-adc-development.html Thu, 23 Oct 2025 00:00:00 +0530 Syngene International, a global contract research, development and manufacturing organization (CRDMO), is adding a GMP bioconjugation suite at its commercial biologics facility [Unit 3] in Bengaluru. With this new capability, Syngene will offer fully integrated, end-to-end services for antibody-drug conjugates (ADCs) – from discovery through to GMP manufacturing – placing it among a handful of CDMOs with full-service capabilities. The OEB-5 rated suite will accelerate ADC development timelines by enabling both Monoclonal Antibodies (mAb) production and GMP bioconjugation at a single site, complementing Syngene’s existing commercial capabilities in payload and linker manufacturing. Expected to be operational within this financial year, the conjugation facility will also support a range of advanced conjugates and related modalities. These services are further strengthened by collocated analytical and bioanalytical capabilities, ensuring seamless integration across the development lifecycle. “The discovery and development of ADCs is complex, often involving multiple vendors and geographically dispersed sites, which adds substantial supply chain complexity and potential delays,” said Alex Del Priore, Head - LM CDMO, Syngene International. “By integrating bioconjugation capabilities with our commercial-scale biologics, payload, and linker production units in Bengaluru, we can significantly compress development timelines and offer a unique, end-to-end pathway from early discovery through to GMP manufacturing,” he added. Building on a decade of experience in ADC discovery and with proven expertise in handling high-potency payloads, linkers, and mAbs across well-established, GMP-compliant facilities, Syngene is scaling its capabilities to support clinical programs and plans to develop commercial-scale capabilities in the future. Additionally, the laboratories will offer process development, analytical characterisation, and scale-up for both early- and late-stage programmes. ]]> https://biospectrumindia.com/news/97/26811/syngene-international-invests-in-dedicated-peptide-laboratory-and-advanced-automation-in-bengaluru.html https://biospectrumindia.com/news/97/26811/syngene-international-invests-in-dedicated-peptide-laboratory-and-advanced-automation-in-bengaluru.html Wed, 15 Oct 2025 00:00:00 +0530 Syngene International, a global contract research, development, and manufacturing organization (CRDMO), has announced site upgrades to accelerate drug discovery and development, helping clients bring novel therapies to market faster. The investments included a dedicated, state-of-the-art peptide laboratory in Bengaluru and the integration of advanced automation across DMPK (Drug Metabolism and Pharmacokinetics) and Direct-to-Biology (D2B) workflows in Hyderabad— boosting scalability, cost-efficiency, and data quality to accelerate therapeutic innovation. The dedicated peptide laboratory is designed to produce a wide range of molecules, including linear peptides, cyclic peptides, and peptide-drug conjugates, and supports synthesis scale-up to 800 mmol (millimole). With six automated peptide synthesizers operating in parallel and equipped with robotic arms, the lab reduces project timelines by weeks or even months while ensuring consistent results. It also features integrated Solid-Phase Peptide Synthesis (SPPS), High-Performance Liquid Chromatography (HPLC), and Liquid-Phase purification, and coupled with Quality Control (QC) laboratories provide innovators with a seamless transition from discovery to development. In parallel, Syngene has made an automation-driven transformation in the DMPK operations. The automation includes Robotic systems for high-throughput sample preparation that reduces turnaround times from five days to three and improves cost efficiency by 30%, and triples sample capacities, providing clients access to critical data much faster. The D2B platform further accelerates hit-to-lead and lead optimization by combining rapid compound design, miniaturized synthesis, and high-throughput screening — saving at least a week for 24-compound sets and several weeks for larger sets.   ]]> https://biospectrumindia.com/news/97/26796/jubilant-hollisterstier-launches-new-high-speed-isolator-based-line-at-us-facility.html https://biospectrumindia.com/news/97/26796/jubilant-hollisterstier-launches-new-high-speed-isolator-based-line-at-us-facility.html Fri, 10 Oct 2025 00:00:00 +0530   Noida-based Jubilant Pharmova has announced that Jubilant HollisterStier LLC (JHS)—a wholly owned subsidiary and a leading North American pharmaceutical contract manufacturer, specialising in sterile injectables and serving top global innovator pharma companies, has launched its New Sterile Fill & Finish line, third at its Spokane Manufacturing Facility in Washington, US. The launch was marked by the successful production of the inaugural batch, initiating revenue generation from the new Line. This milestone denotes a significant advancement in Jubilant HollisterStier’s multi-phase expansion strategy and brings an additional 50% capacity at its Spokane manufacturing facility.     The New Line features advanced isolator technology designed to deliver enhanced sterility assurance, throughput and operational precision. Built to meet the highest global regulatory standards, the New Line significantly enhances the company’s ability to support complex injectable programs across a broad range of therapeutic areas. The $132 million investment towards this New Third Line, reflects the company’s long-term commitment to innovation, quality and supply chain resilience. Together with the commissioning of its upcoming Fourth Line, JHS is on track to double its total sterile injectable manufacturing capacity at its Spokane facility in the US. This strategic investment further reinforces JHS’ leadership in domestic US pharmaceutical manufacturing. By expanding its infrastructure and increasing onshore capacity, the company is contributing to US national health security and helping to reduce reliance on offshore supply chains— delivering a more resilient and agile pharmaceutical manufacturing ecosystem. ]]> https://biospectrumindia.com/news/97/26786/sai-life-sciences-agility-life-sciences-and-centrix-pharma-team-up-to-accelerate-drug-development-for-innovators.html https://biospectrumindia.com/news/97/26786/sai-life-sciences-agility-life-sciences-and-centrix-pharma-team-up-to-accelerate-drug-development-for-innovators.html Thu, 09 Oct 2025 00:00:00 +0530 Sai Life Sciences, Agility Life Sciences, and Centrix Pharma Solutions has announced the launch of an Integrated CMC Partnership designed to provide innovator biopharma companies with end-to-end Chemistry, Manufacturing and Controls (CMC) services. The collaboration combines the extensive CMC expertise of Sai Life Sciences in API development, Agility Life Sciences in formulation development, and Centrix Pharma Solutions in drug product development and clinical manufacturing.  Through this partnership, customers will have access to integrated drug substance and drug product development, helping them move efficiently from preclinical studies to first-in-human (FIH) clinical trials and beyond.   By combining deep expertise across the CMC value chain, the Integrated CMC Partnership helps customers create and execute holistic development plans—translating molecular hits into new medicines. Key benefits include:  Broad scientific expertise across multiple disciplines, supported by extensive laboratory and manufacturing facilities  End-to-end service coverage from synthetic route scouting to drug substance manufacturing, and from pre-formulation through to clinical trial material manufacturing Cross-functional optimization: integrated planning across API and drug product development, reducing duplication, risks, costs, and timelines  Agility and flexibility to respond proactively to emerging technical risks across functions Seamless coordination between technical teams, including proactive sample transfer and early API evaluation in the drug product process  Single point of contact from Day One, ensuring alignment and accountability throughout project execution   ]]> https://biospectrumindia.com/news/97/26772/eli-lilly-announces-over-1-b-investment-in-new-contract-manufacturing-in-india.html https://biospectrumindia.com/news/97/26772/eli-lilly-announces-over-1-b-investment-in-new-contract-manufacturing-in-india.html Mon, 06 Oct 2025 00:00:00 +0530 US-based Eli Lilly and Company has announced plans to invest more than $1 billion over the next several years into new contract manufacturing in India, expanding patients’ access to innovative medicines around the world. This strategic investment will further strengthen the manufacturing and supply capabilities to support our evolving portfolio. In addition, Lilly will establish a new Manufacturing & Quality presence in Hyderabad. This new hub will offer advanced technical capabilities and oversight for Lilly’s contract manufacturing network across India. Recruitment will begin immediately, with openings across roles such as engineers, chemists, analytical scientists, quality control and assurance professionals, and management positions. This initiative reflects Lilly’s intent to leverage India’s highly skilled talent pool to support its global manufacturing growth and deliver medicines to patients worldwide. Since 2020, Lilly has committed more than $55 billion to build, expand, and acquire facilities in the US and around the world. These facilities and investments address growth from potential new medicines to treat diabetes and obesity, Alzheimer’s disease, cancer and autoimmune conditions and prepare for medicines of the future. A. Revanth Reddy, Chief Minister of Telangana, said, “Lilly’s continued expansion in Hyderabad highlights the city’s emergence as a powerhouse in global healthcare innovation. From the recent opening of its Innovation and Technology site to a new manufacturing collaboration and the establishment of a Manufacturing & Quality hub, Lilly is moving swiftly to expand its presence in Telangana — reinforcing the state’s position as a preferred destination for cutting-edge healthcare investments.” “We are making significant investments to increase manufacturing and medicine supply capacity around the world to help ensure patients have access to the medicines they need,” said, Patrik Jonsson, Executive Vice President and President Lilly International, Eli Lilly and Company. “Working with trusted contract manufacturers expands our capabilities to deliver life-changing medicines at greater scale — with quality always at the core. This investment reaffirms our confidence in India as a hub for capability building within our global network.” ]]> https://biospectrumindia.com/news/97/26718/intrinseque-health-secures-iso-iec-270012022-certification.html https://biospectrumindia.com/news/97/26718/intrinseque-health-secures-iso-iec-270012022-certification.html Wed, 24 Sep 2025 00:00:00 +0530 Intrinseque Health has earned the ISO/IEC 27001:2022 certification, a globally recognised standard for information security management. This new achievement further strengthens the company’s already impressive portfolio of certifications, which includes EN ISO 13485, ISO 9001, and GDPMDS, reinforcing its position as a trusted partner for clinical trial support services worldwide. Known for its operational excellence and commitment to quality, Intrinseque Health has consistently delivered top-tier clinical supply chain solutions to pharmaceutical, biotechnology, and contract research organisations. The addition of the ISO/IEC 27001:2022 certification marks a pivotal moment, ensuring that the company's systems uphold not only high standards of quality and compliance but also safeguard sensitive information with the highest levels of security. “Information security is no longer optional; it is an essential expectation from our clients and partners,” said Nitin Jain, President & CEO, Intrinseque Health. “Achieving ISO/IEC 27001:2022 certification demonstrates our proactive commitment to protecting our information assets. This reinforces the trust placed in us by global stakeholders and ensures that we continue to meet and exceed the international standards for both quality and security.” The certification process included a thorough independent audit, which assessed Intrinseque Health’s governance structure, risk management processes, and security systems. The successful outcome confirms that the company has developed an integrated approach that not only prevents data breaches and reduces risks but also ensures business continuity and resilience in an ever-changing regulatory landscape. As the clinical research industry faces increasingly complex challenges, from regulatory compliance to data protection, Intrinseque Health’s attainment of ISO/IEC 27001:2022 certification represents a key milestone that enhances its ability to support global clinical trials with confidence and credibility. Around the globe, Intrinseque Health has offices in countries like the United States (Delaware), The Netherlands (Amsterdam), United Kingdom (London), China (Beijing), Taiwan (Taipei) & Korea (Seoul), India (Delhi), Malaysia (Melaka) and Singapore.   ]]> https://biospectrumindia.com/news/97/26669/pharmaceutical-cdmo-player-cotec-healthcare-files-ipo-papers-with-sebi.html https://biospectrumindia.com/news/97/26669/pharmaceutical-cdmo-player-cotec-healthcare-files-ipo-papers-with-sebi.html Fri, 12 Sep 2025 00:00:00 +0530 Cotec Healthcare Limited, a leading player in the contract development and manufacturing organization (CDMO) industry in India in terms of number of dosage forms with capabilities across 24 distinct formulation types, has filed its Draft Red Herring Prospectus comprising Fresh Issue of up to Rs 2,950 million and Offer for Sale of up to 6,000,000 Equity Shares of face value of Rs 5 each. The company operates as a CDMO engaged in development of formulation, loan licensing and commercial manufacturing of off-patent products, including complex generics, in more complex delivery forms such as modified and sustained release forms, for institutional and private customers.  The company’s portfolio encompasses a wide spectrum of products and services across multiple dosage forms including injectables, tablets, capsules, ointments, eye drops, ampoules, vials, liquid and dry syrups, and infusions, among others. Cotec is one of the fastest-growing company amongst its peers, with a revenue CAGR of 52.72% from Fiscal 2023 to Fiscal 2025, based on Restated Consolidated Financial Statements. For Fiscal 2025, the company reported revenue of Rs 1,922 million, underscoring the effectiveness of its strategic realignment and its contribution to improved operating performance. The company’s manufacturing facility, located in Roorkee (Uttarakhand), has an aggregate installed capacity of 4,051 million units as of March 31, 2025. The facility comprises three dedicated manufacturing units, each designed to comply with regulatory requirements for specific product categories, while also allowing for strategic segregation of different types of pharmaceutical products. Situated in Roorkee, the facility benefits from Uttarakhand’s well-established and supportive pharmaceutical manufacturing ecosystem. In order to capture the growing demand for specialised products in the pharmaceutical industry, the company intends to establish a new unit, with a total capacity of 12,007 million units, which will include a high-capacity OSD block, a dedicated oncology unit, a comprehensive penicillin portfolio (including tablets, capsules, dry syrups and injectables), and an additional SVP manufacturing block. The unit will also feature sterile manufacturing lines for ampoules, vials, dry powder injections and form–fill–seal (FFS) eye drops. The Fresh Issue proceeds would be utilised towards the capital expenditure requirement for setting up the project. ]]> https://biospectrumindia.com/news/97/26655/enzene-announces-opening-of-new-continuous-biomanufacturing-facility-in-us.html https://biospectrumindia.com/news/97/26655/enzene-announces-opening-of-new-continuous-biomanufacturing-facility-in-us.html Fri, 05 Sep 2025 00:00:00 +0530 Governor Phil Murphy officially inaugurated the state-of-the-art biomanufacturing facility of Pune-based Enzene, a leading global continuously innovative development and manufacturing organization (CIDMO), marking a significant milestone in the expansion of global biotech capabilities in the United States. Located in Hopewell, the new 80,000-sq.-ft. facility represents Enzene’s first major manufacturing investment in the US, reinforcing its commitment to supporting pharmaceutical innovation and supply chain resilience across North America. As well as fed-batch drug substance manufacturing, the site makes extensive use of the company’s modular EnzeneX™ 2.0 platform, which is the world’s first fully-connected continuous manufacturing™ (FCCM™) technology. The innovative platform is sustainable and scalable, and leverages optimised cell media and process analytical technology (PAT) to achieve 10-times the yield of conventional biomanufacturing and reduce the cost of goods sold (COGS) to as low as $40 per gram. “When Enzene — one of India’s most promising biotechnological companies — decided to launch its very first US manufacturing base, they knew there was nowhere better to do it than right here in New Jersey. Their decision reflects not only our state’s strength as a hub for global business and innovation, but also the deep cultural ties that bind New Jersey and India,” said Governor Phil Murphy. “This state-of-the-art facility represents the future of advanced manufacturing — ultimately creating hundreds of jobs and generating $50 million in investment. As Enzene expands its presence here in New Jersey, we remain committed to supporting the company as it builds the world-class manufacturing ecosystem of tomorrow.” “We are proud to bring our global expertise to the US and contribute to the advancement of biopharmaceutical manufacturing,” added Himanshu Gadgil, Ph.D., CEO of Enzene. “Our first-to-market manufacturing technology is forging a new path in biologics manufacturing that will provide a cost-efficient, high yield, US-based biomanufacturing solution for biopharmaceutical innovators, and complement our facilities in India to provide global supply solutions.”   ]]> https://biospectrumindia.com/news/97/26631/aurigene-pharma-launches-new-database-for-accelerated-hit-identification.html https://biospectrumindia.com/news/97/26631/aurigene-pharma-launches-new-database-for-accelerated-hit-identification.html Tue, 02 Sep 2025 00:00:00 +0530 Bengaluru-based Aurigene Pharmaceutical Services, a leading Contract Research, Development and Manufacturing Organization (CRDMO), has announced the launch of the Aurigene Database (Aurigene DB – Virtual Library) on the CHEESE (Chemical Exploration Engine for Similarity & Substructure Exploration) platform. This new resource enables compound similarity and substructure searches, providing researchers with a powerful tool to identify early hits in drug discovery programmes. This initiative marks a significant milestone for Aurigene’s scientific community, reflecting both innovation and self-reliance. The achievement brings immense pride to the team, who have worked relentlessly for over two years to make this vision a reality. “Our vision with the Aurigene Database is to empower researchers with seamless access to high-quality chemical space, while reducing dependency on external vendors for compound procurement in hit identification,” said Shahadat Ahmed, PhD, Head of Integrated Drug Discovery at Aurigene Pharmaceutical Services. “This launch exemplifies our commitment to innovation and efficiency in supporting drug discovery programmes worldwide through AIDD, IDD and IND enabling services” Key Highlights of the Aurigene Database on CHEESE: Powerful Search Capabilities - Conduct compound similarity and substructure searches. Streamlined Hit Identification - Quickly identify focused sets of compounds for early discovery. Integrated Business Model - Researchers can reach out to Aurigene services for synthesis support of identified hits. Independence from External Vendors - Enabling in-house compound accessibility and reducing procurement hurdles.     ]]> https://biospectrumindia.com/news/97/26618/piramal-pharma-solutions-supports-george-medicines-in-developing-new-drug-for-hypertension.html https://biospectrumindia.com/news/97/26618/piramal-pharma-solutions-supports-george-medicines-in-developing-new-drug-for-hypertension.html Fri, 29 Aug 2025 00:00:00 +0530 London-based George Medicines, a leading late-stage biopharma company, in partnership with Mumbai-based Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., has developed WIDAPLIK, a new drug for treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. The US Food and Drug Administration (FDA) approved WIDAPLIK on June 6, 2025. WIDAPLIK is a single pill combination of three medicines, telmisartan, amlodipine, and indapamide, for the treatment of hypertension, developed in three doses (10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg strengths), including two doses that are lower than those currently available in single pill combinations. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Its multi-mechanism approach and available doses are formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the established safety profile of its three component antihypertensive medications. George Medicines and Piramal Pharma Solutions began their collaboration on WIDAPLIK in December 2018, when the formulation was developed at Piramal's Pharmaceutical Development site in Ahmedabad. In June 2020, the project was transferred to Piramal's drug product facility in Pithampur for validation and manufacturing. Leveraging Piramal's vast technical expertise and extensive experience advancing innovations, George Medicines achieved FDA approval for WIDAPLIK this year.   ]]> https://biospectrumindia.com/news/97/26590/akums-to-establish-pharmaceutical-manufacturing-facility-in-zambia.html https://biospectrumindia.com/news/97/26590/akums-to-establish-pharmaceutical-manufacturing-facility-in-zambia.html Mon, 25 Aug 2025 00:00:00 +0530 Akums, a Delhi-based contract development and manufacturing organization (CDMO), and The Government of The Republic of Zambia (GRZ), have announced a partnership to set up a manufacturing facility in Zambia to provide high quality and affordable generic medicines for patients in Zambia. The partnership will involve setting up a state-of-the-art manufacturing facility in Zambia to manufacture and supply medicines in Zambia. The joint venture (JV) also, in the future, will export to neighboring African countries like Zimbabwe, Namibia, Botswana, Malawi, Tanzania, Mozambique etc. The manufacturing facility will be housed in a newly formed Joint venture company, which will be headquartered in Zambia. Akums will hold 51% while GRZ, though its nominated state instrumentality, will hold 49% in this joint venture. The JV will be managed by a Board with representatives from both partners. The JV is expected to be established by Q3 FY 26, post which the construction of facility will begin. Commercial supplies from the facility are expected to begin in Q3 FY 28, subject to timely establishment of the facility and regulatory approvals for the facility and products. The facility will manufacture tablets, hard gelatin capsules, liquids, injectables as well as beta-lactam products. Both partners will contribute in the establishment and operationalization of the facility in ratio of their shareholding. To fulfill the current national healthcare needs, the Govt. of Zambia has also committed to purchase essential medicines from Akums’ facilities in India to Zambia. The supply will be of minimum $25 million annually in calendar years 2026 and 2027. ]]> https://biospectrumindia.com/news/97/26566/piramal-pharma-solutions-makes-investment-to-enhance-oral-solid-dosage-production-capabilities-in-us.html https://biospectrumindia.com/news/97/26566/piramal-pharma-solutions-makes-investment-to-enhance-oral-solid-dosage-production-capabilities-in-us.html Thu, 21 Aug 2025 00:00:00 +0530 Mumbai-based Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., and NewAmsterdam Pharma Company N.V. have announced the opening of a dedicated oral solid dosage (OSD) form suite at Piramal's facility in Sellersville, Pennsylvania, USA. As one of Piramal Pharma Solutions' focused drug product facilities, the Sellersville site provides comprehensive development and manufacturing services for various formulations, including several forms of OSDs. This addition will increase operational efficiency, helping NewAmsterdam Pharma to deliver its investigational drug therapy, if approved, to patients in need. The suite represents a multi-million-dollar investment in equipment upgrades and enhancements to improve the site's capabilities. This includes a reconfiguration of existing space to create a dedicated OSD suite that will be used exclusively for fixed dose combination products. The new suite is designed for turnkey, multi-layer tablet production, equipped with advanced capabilities and technology to support granulation, compression, tableting, and coating. This suite will facilitate the production of NewAmsterdam Pharma's investigational FDC, a non-statin cholesterol medication to reduce LDL-C.  Although the suite is essential to the FDC's production, the partnership between Piramal Pharma Solutions and NewAmsterdam Pharma extends beyond the Sellersville site. Piramal's Ahmedabad PPDS site played a crucial role in the product's development, while its Pithampur site provides dual sourcing support. ]]> https://biospectrumindia.com/news/97/26524/cohance-lifesciences-injects-rs-23-cr-into-cgmp-oligonucleotide-facility-at-hyderabad.html https://biospectrumindia.com/news/97/26524/cohance-lifesciences-injects-rs-23-cr-into-cgmp-oligonucleotide-facility-at-hyderabad.html Tue, 12 Aug 2025 00:00:00 +0530 Cohance Lifesciences Limited, formerly Suven Pharmaceuticals, a partner of choice for global innovator pharma companies, has announced Rs 23 crore investment and significant progress on its new cGMP oligonucleotide building block manufacturing facility in Hyderabad. This strategic investment strengthens the CRDMO’s integrated oligonucleotide platform and enhances its position as a preferred partner for emerging modalities. Cohance brings deep expertise in modified nucleosides and locked nucleic acids (LNA), with a proven track record in complex nucleoside and nucleic acid synthesis at the R&D stage. The new facility will enable the company to take these high-value chemistries from laboratory scale to full commercial manufacturing, meeting the needs of innovators advancing oligonucleotide-based therapeutics. Integrated with pilot plant for early-stage synthesis and for non-GMP scale-up, the facility will add fit-for-purpose GMP capacity of up to 700 kg annually, with room for future expansion. This scale, combined with advanced environmental controls including ISO Class 8 clean rooms and RH-controlled areas, is designed to meet the stringent requirements of complex oligonucleotide building block production. Customer engagements are already underway, with audits planned in the coming quarters. Kilo lab validations and modified nucleotides are in progress, with GMP-grade PMO and LNA amidite validations expected to commence in CY26.   ]]> https://biospectrumindia.com/news/97/26525/cohance-lifesciences-announces-10-m-investment-in-cgmp-bioconjugation-suite-in-us.html https://biospectrumindia.com/news/97/26525/cohance-lifesciences-announces-10-m-investment-in-cgmp-bioconjugation-suite-in-us.html Tue, 12 Aug 2025 00:00:00 +0530 Hyderabad-based Cohance Lifesciences, a leading global Contract Research, Development & Manufacturing Organisation (CRDMO), has announced a strategic investment of $10 million to expand cGMP bioconjugation capabilities at its US based subsidiary, NJ Bio. Aligned with the company’s long-term strategy, this investment advances Cohance’s global expansion in niche technology-led modalities, enhancing its ability to support innovators from early development through late-phase clinical supply. The build-out of a state-of-the-art, cGMP compliant bioconjugation suite at NJ Bio’s Princeton, New Jersey facility significantly strengthens the company’s capabilities to deliver fully integrated Antibody-Drug Conjugate (ADC) solutions - from early-phase payload-linker synthesis through to complete ADC manufacturing for clinical supply. NJ Bio is currently executing a major new programme for an existing innovator customer with multiple ADC candidates in their pipeline. The engagement spans early-phase payload-linker development—already underway—and will advance to cGMP bioconjugation upon commissioning of the new suite. This collaboration underscores the customer’s confidence in NJ Bio’s ability to deliver complex chemistry solutions and end-to-end ADC manufacturing support for Phase 1 and Phase 2 clinical studies. The new suite, designed to handle high-potent drug substances, will have the flexibility to manufacture up to 2 kg of ADCs, sufficient for clinical requirements once the programme transitions to cGMP production in the expanded facility. The facility is expected to be operational by the end of Q4FY26, with related bioconjugation work commencing thereafter. Beyond this, NJ Bio is in advanced discussions with three to four additional customers whose ADC programmes are expected to transition to cGMP manufacturing in alignment with the commissioning of the expanded suite. Recently NJ Bio has expanded its linker-payload capabilities with a dedicated lab, completing one GMP campaign with two more underway. The global ADC market, valued in the billions, is experiencing robust growth driven by rising cancer incidence and increasing demand for targeted immuno-oncology therapies.  ]]> https://biospectrumindia.com/news/97/26476/alveolus-bio-secures-strategic-investment-from-shilpa-medicare-.html https://biospectrumindia.com/news/97/26476/alveolus-bio-secures-strategic-investment-from-shilpa-medicare-.html Mon, 04 Aug 2025 00:00:00 +0530 Alveolus Bio, a US-based respiratory drug development biotech company founded by Dr. Vivek Lal from University of Alabama at Birmingham, has announced a strategic financing round led by Raichur-based Shilpa Medicare Limited, a prominent global pharmaceutical company with extensive expertise in respiratory therapeutics manufacturing and biotechnology innovation. Through this collaboration, Shilpa Biologics, the biologics arm of Shilpa Medicare, will become Alveolus Bio's exclusive global development and manufacturing partner. This partnership propels Alveolus Bio's live biotherapeutics and small molecule platform towards Phase 2 and first-in-human clinical trials, with a lead asset for Chronic obstructive pulmonary disease (COPD) progressing rapidly. Shilpa Medicare brings deep experience in drug discovery, development, and manufacturing, along with strong regulatory capabilities. Their investment and strategic involvement will accelerate the clinical advancement of Alveolus Bio's resMIT (respiratory microbiota-based inhaled therapeutics) platform. This novel platform enables targeted delivery of inhaled therapies to deep lung regions, addressing unmet needs in diseases such as COPD, Bronchopulmonary Dysplasia (BPD), and Pulmonary Fibrosis. "Alveolus Bio's breakthrough science is poised to transform respiratory care. Through this strategic partnership with Shilpa, we combine disruptive biotech innovation with world-class commercialization, bringing life-changing therapies faster to the market," said Dr C. Vivek Lal, Founder and CSO, Alveolus Bio. "Shilpa has always focused on enabling breakthrough biologics," said Vishnukant Bhutada, Managing Director, Shilpa Medicare. "This partnership strengthens our innovation pipeline and reinforces our role as a trusted global partner for biotech development." The financing round remains open to other strategic investors who share Alveolus Bio's vision of transforming respiratory medicine. ]]> https://biospectrumindia.com/news/97/26346/veeda-lifesciences-brings-ai-innovation-to-clinical-trial-services.html https://biospectrumindia.com/news/97/26346/veeda-lifesciences-brings-ai-innovation-to-clinical-trial-services.html Tue, 08 Jul 2025 00:00:00 +0530 Ahmedabad-based contract research organization (CRO) Veeda Lifesciences has announced an investment in Mango Sciences, a Boston-based healthcare AI and data company. With this investment, Veeda intends to leverage AI capabilities to improve the speed, efficiency and quality of clinical trial services across its expanded global network, enabling more diverse and efficient recruitment as well as globally representative patient selection. Building on the Querent platform™ powered by Mango Sciences' AI, Veeda will effectively use the technology to automate accurate patient identification and expand its reach across Europe. "Our partnership will make Veeda an AI-driven oncology drug development organisation that can meet the growing demand for diversity in clinical trials, in line with the expectations of regulators and pharmaceutical companies. We will be one of the few oncology CROs with access to this proprietary technology," said Mahesh Bhalgat, Group Executive Director and Managing Director of Veeda Clinical Research Limited. By deploying the Querent platform™ powered by AI, Veeda will streamline processes, improve data management capabilities, and ensure higher quality standards through broader representation of non-Caucasian populations. This will increase the efficiency of clinical trials through advanced data analytics, benefiting patient matching, trial design and monitoring, while reducing costs and time.   ]]> https://biospectrumindia.com/news/97/26324/auriga-and-san-francisco-research-institute-ink-mou-to-advance-ai-driven-clinical-research.html https://biospectrumindia.com/news/97/26324/auriga-and-san-francisco-research-institute-ink-mou-to-advance-ai-driven-clinical-research.html Thu, 03 Jul 2025 00:00:00 +0530 Delhi-based Auriga Research, a leading Contract Research Organization (CRO), has entered into a strategic Memorandum of Understanding (MoU) with San Francisco Research Institute (SFRI), a US-based healthcare research and innovation organisation. This collaboration aims to strengthen global clinical research, promote AI-integrated healthcare solutions, and expand access to compliant wellness products across India, the United States, and Africa. The partnership outlines a joint framework to support clinical trials, regulatory pathways, digital health innovation, and international business development. It brings together Auriga’s strong infrastructure and expertise in India and Asia with SFRI’s global capabilities across North America, Europe, and Africa. Key outcomes of the collaboration include Joint clinical trials using AI for patient recruitment, monitoring, and analytics; Auriga to lead clinical operations, data management, and regulatory execution in India; SFRI to drive client engagement and Market expansion in the US, Japan, and Europe; Co-development of new formulations and wellness products for global markets; Joint applications for grants and funded clinical research projects; SFRI to connect Auriga with marketers and public health agencies in Africa for expansion. San Francisco Research Institute will also support regulatory strategy, public health collaboration, and commercial partnerships in markets such as Nigeria and the US. This includes enabling product registration with national health agencies, connecting Auriga to distributors and marketers, and directly supporting sales outreach and supply chain strategies. The two organisations will jointly expand their Research Training Programme through both digital platforms and in-person sessions, while also co-developing new products and AI applications for healthcare. Additionally, they will pursue government and foundation-funded projects to further their impact on global health systems. ]]> https://biospectrumindia.com/news/97/26310/piramal-pharma-solutions-breaks-ground-on-90-m-expansion-plan-in-us.html https://biospectrumindia.com/news/97/26310/piramal-pharma-solutions-breaks-ground-on-90-m-expansion-plan-in-us.html Mon, 30 Jun 2025 00:00:00 +0530 Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organisation (CDMO) and part of Piramal Pharma Ltd., recently announced a $90 million investment plan to expand two of its US facilities, which are critical to its integrated offering. The two sites involved in the expansion are: Riverview, Michigan: The Riverview site provides comprehensive drug substance development and manufacturing services, including specialised solutions for high potency APIs (HPAPIs). This facility is a vital element of ADCelerate™, supplying the payload-linkers essential to the overall safety, stability, and efficacy of ADC therapies. The expansion will add a commercial-scale suite specifically designed for the development and manufacturing of payload-linkers, which is expected to be operational by the end of 2025. Lexington, Kentucky: The Lexington site is Piramal Pharma's dedicated fill/finish facility, specializing in sterile compounding, liquid filling, and lyophilization for sterile injectable drug products. As a critical component of Piramal Pharma's integration, the site provides fill/finish services for all integrated programs, including ADCelerate™ projects. The expansion will add commercial-scale sterile injectable manufacturing capabilities with 24,000 additional square feet of manufacturing space, a new laboratory, and state-of-the-art machinery, including a new filling line, two commercial-size lyophilisers, a specialised capping machine, and an external vial washer. The expansion is expected to be completed by late 2027.  "Our research has revealed that the sterile injectables market is projected to exceed $20B by 2028, underscoring the urgent need for us to enhance our offerings in this segment. We are confident that this strategic $90M investment will empower us to meet the demands of this market, reinforcing our position as a trusted global partner in biologic manufacturing. By enhancing the services we provide to our partners, we can reduce the burden of disease for more patients around the globe," said Nandini Piramal, Chairperson, Piramal Pharma. ]]> https://biospectrumindia.com/news/97/26300/kashmik-formulation-to-expand-capacity-eyes-rs-100-cr-revenue-in-fy26.html https://biospectrumindia.com/news/97/26300/kashmik-formulation-to-expand-capacity-eyes-rs-100-cr-revenue-in-fy26.html Sat, 28 Jun 2025 00:00:00 +0530 Kashmik Formulation, a pharmaceutical manufacturing company headquartered in Ahmedabad, has announced significant expansion plans aimed at increasing production capacity, strengthening its presence in international markets, and enhancing operational efficiencies through automation. The company has also set an ambitious revenue target of Rs 100 crore for the financial year 2025–26, following a 100% year-on-year growth from Rs 20 crore to RS 40 crore in FY24–25. Currently operating at full capacity with a daily output of 1 crore tablets, the company is planning to undertake a 50% capacity enhancement to scale up production to 1.5 crore tablets per day. An investment of approximately Rs 20 crore will be allocated towards this expansion, with infrastructure development already underway to support the planned growth. Kashmik Formulation currently derives approximately 70% of its revenue from its own branded generics and 20–30% from contract manufacturing for reputed pharmaceutical clients. Exports account for 20% of the company’s revenue, and plans are in place to increase this share to 50% over the next few years. The company is in the process of registering its products in several semi-regulated international markets, including Myanmar, Latin America, and select African countries. Further, the company is investing Rs 4–5 crore in the automation of its packaging operations, to enhance productivity and ensure compliance with evolving industry standards. Plans are also underway to establish a new R&D centre in Jammu, with a long-term vision to diversify into injectables within the next 3 to 5 years. While the company is not currently raising external capital, it is actively exploring the possibility of an Initial Public Offering (IPO) within the next 2 to 3 years as part of its strategic roadmap.   ]]> https://biospectrumindia.com/news/97/26240/shilpa-medicare-signs-commercial-supply-deal-with-orion-for-recombinant-human-albumin.html https://biospectrumindia.com/news/97/26240/shilpa-medicare-signs-commercial-supply-deal-with-orion-for-recombinant-human-albumin.html Fri, 13 Jun 2025 00:00:00 +0530 Raichur-based Shilpa Biocare Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited, has secured a Europe-wide commercial supply agreement with Orion Corporation for Recombinant Human Albumin. Shilpa’s Recombinant Human Albumin – a key plasma protein used in various therapeutic applications – is currently under development and will be manufactured using a robust non-human expression system. This provides improved safety, scalability, and virus-free production, addressing some of the key limitations associated with human-derived albumin. Under the terms of the agreement, Orion will gain exclusive rights to distribute, market and sell Shilpa’s Recombinant Human Albumin in Europe, with Shilpa receiving development and regulatory milestone payments from Orion. “We are pleased to strengthen our strategic partnership with Shilpa by collaborating on this novel product,” said Satu Ahomäki, EVP Generics and Consumer Health, Orion Corporation. “Recombinant human albumin will strengthen our strategy and offering in value-add hospital generics, and we look forward to making it available across Europe.” At BIO Boston event later this month, Shilpa is expected to see increased interest from biopharma innovators, particularly smaller biotech firms, leveraging its development capabilities in oncology and biologics – with the CDMO having both commercial facilities for both mammalian and microbial production. Madhav Bhutada, Managing Director, Shilpa Biocare, added: “Partnering with Orion is a significant step in bringing our innovative recombinant product to patients across Europe and is a testimonial of our developmental and manufacturing capabilities to bring Recombinant Human Albumin to market. This alliance aligns with our mission to provide high-quality, affordable biologics globally, and we are confident this partnership will further accelerate our footprint in the regulated markets.” ]]> https://biospectrumindia.com/news/97/26238/sava-healthcare-secures-cdsco-nod-for-nasal-spray-targeting-allergic-rhinitis-with-congestion.html https://biospectrumindia.com/news/97/26238/sava-healthcare-secures-cdsco-nod-for-nasal-spray-targeting-allergic-rhinitis-with-congestion.html Thu, 12 Jun 2025 00:00:00 +0530 SAVA Healthcare Limited, a leading contract development and manufacturing organization (CDMO) in the Indian pharmaceutical sector, has received its first drug approval from the Drug Controller General of India (DCGI) for a combination nasal spray indicated for the treatment of allergic rhinitis with nasal congestion. The approved formulation contains Fluticasone Furoate (27.5 mcg) and Oxymetazoline Hydrochloride (50 mcg) and is designed for targeted relief of allergy-induced nasal symptoms, including inflammation and congestion. The product will be manufactured at SAVA Healthcare’s state-of-the-art facility in Surendranagar, Gujarat, which complies with stringent regulatory requirements and quality standards. Packaged in high-density polyethylene (HDPE) bottles equipped with a metered spray pump, the nasal spray ensures precise dosing and user-friendly administration. This formulation combines the anti-inflammatory properties of fluticasone, a corticosteroid, with the decongestant effect of oxymetazoline, offering comprehensive symptomatic relief for patients suffering from seasonal and perennial allergic rhinitis. All regulatory and technical prerequisites laid out by the Central Drugs Standard Control Organisation (CDSCO) were met during the approval process, highlighting SAVA Healthcare’s growing competency in complex formulations and respiratory drug delivery systems.  With the launch of this formulation, SAVA Healthcare not only enters a new product category under its own license but also sets the stage for future filings and tech transfers in the complex nasal spray segment, both for India and international markets. ]]> https://biospectrumindia.com/news/97/26229/onesource-and-xbrane-biopharma-announce-strategic-biosimilars-manufacturing-partnership-for-global-markets.html https://biospectrumindia.com/news/97/26229/onesource-and-xbrane-biopharma-announce-strategic-biosimilars-manufacturing-partnership-for-global-markets.html Wed, 11 Jun 2025 00:00:00 +0530 Bengaluru-based OneSource Specialty Pharma Limited, multi-modality specialty pharma pure-play CDMO, and Xbrane Biopharma AB, a Sweden-headquartered biotechnology company, have announced a strategic partnership focused on the commercial manufacturing of Xbrane’s biosimilar portfolio. Xbrane has a portfolio of biosimilar candidates targeting EUR 23 billion in estimated annual peak sales of the respective reference products. The lead candidate Ximluci (a ranibizumab biosimilar) is granted market authorisation approval in Europe (launched in 2023) and is now under the approval process for the US launch. As part of the agreement, Xbrane will tech transfer its commercial product to OneSource’s state-of-the-art integrated Drug Substance and Drug Product (DS/DP) facility in Bengaluru. The collaboration aims to strengthen Xbrane’s global supply chain, while enabling OneSource to accelerate regulatory approvals, including from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics drugs substance facility. As part of the collaboration, OneSource has also participated in Xbrane’s latest funding round, reinforcing the long-term strategic alignment between the two companies. Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, said, "The partnership with Xbrane reflects our shared ambition to drive broader access to cutting-edge biologics worldwide. Xbrane’s proven success in biosimilar development, combined with OneSource’s fully integrated biologics platform, creates a strong platform for global impact. We are pleased to support the scale-up of high-quality biosimilars and advance our vision of being a trusted partner to the world’s leading biotech companies." Martin Åmark, CEO of Xbrane Biopharma, added: “Our partnership with OneSource gives us access to top-tier, cost-competitive manufacturing and expertise for our biosimilars. This is essential for our global competitiveness and our commitment to providing affordable medicines to patients and payers.” ]]> https://biospectrumindia.com/news/97/26198/agenus-and-zydus-lifesciences-enter-141-m-strategic-collaboration-for-biologics-manufacturing-in-us.html https://biospectrumindia.com/news/97/26198/agenus-and-zydus-lifesciences-enter-141-m-strategic-collaboration-for-biologics-manufacturing-in-us.html Tue, 03 Jun 2025 00:00:00 +0530 US-based Agenus Inc., a leader in immuno-oncology innovation, has signed definitive partnership agreements with Ahmedabad-based Zydus Lifesciences, including its subsidiaries/affiliates, designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL). The strategic collaboration includes an exchange of Agenus’ state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75 million; Agenus to receive up to an additional $50 million in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship US sites to provide biologics contract manufacturing services to biopharmaceutical companies globally. Agenus will become Zydus’ first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen’s BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialisation. Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus’ established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries. ]]> https://biospectrumindia.com/news/97/26142/shilpa-biologicals-opens-bioconjugation-manufacturing-site-in-dharwad.html https://biospectrumindia.com/news/97/26142/shilpa-biologicals-opens-bioconjugation-manufacturing-site-in-dharwad.html Wed, 21 May 2025 00:00:00 +0530 Shilpa Biologicals, a full-service contract development and manufacturing organisation (CDMO), has announced the opening of a dedicated bioconjugation suite at its Dharwad site in Karnataka. Located adjacent to the company’s existing commercial biologics manufacturing facility, the suite is currently undergoing validation and is expected to begin onboarding client programmes by September 2025. This latest expansion positions Shilpa Biologicals among a select group of global CDMOs capable of providing clinical and commercial-scale manufacturing across all three-core antibody-drug conjugate (ADC) components – payloads/linkers, monoclonal antibodies, and bioconjugation — and within a single, integrated campus. The new suite is backed by one of the industry’s largest payload and linker libraries, with a multi-ton high-potency active pharmaceutical ingredient (HPAPI) capacity. In fact, the CDMO currently manufactures approximately 40% of the oncological HPAPIs in use today from its USFDA-approved facilities. It’s 10 cGMP HPAPI suites are equipped to handle compounds with occupational exposure limits (OELs) below 0.01 µg/m³ – ensuring safe and compliant processing of even the most potent ADC payloads. The new multi-client bioconjugation suite is built to support the manufacture of ADCs and other advanced bioconjugates progressing through the pipeline, and includes 200L single use bioconjugation reactors and a lyophilisation capacity of up to 65 kg. Complementary development laboratories will provide process development, analytical characterisation, and both early and late-stage scale-up capabilities. For final dose requirements, Shilpa’s Hyderabad site is equipped with multiple isolator-based fill-finish lines dedicated to cytotoxic products. Shilpa Biologicals, Chief Executive Officer Dr Sridevi Khambhampaty commented; “We are seeing an unprecedented wave of ADC innovation entering clinical development — yet only a handful of CDMOs globally offer true end-to-end capabilities. Our co-located ADC services — spanning payloads, linkers, antibodies, and bioconjugation — are generating significant industry interest, especially from US and European biotech companies seeking a single, reliable partner to support their journey from discovery to commercial launch. ]]> https://biospectrumindia.com/news/97/26116/steerlife-redefines-potent-drug-development-with-clean-green-continuous-processing.html https://biospectrumindia.com/news/97/26116/steerlife-redefines-potent-drug-development-with-clean-green-continuous-processing.html Thu, 15 May 2025 00:00:00 +0530 Bengaluru-based STEERLife, the life sciences division of STEER World, is advancing the development and manufacturing of potent and complex drug products. This initiative marks a significant advancement in a field that has long been considered one of the most challenging areas within pharmaceutical science.   At the core of this advancement is STEERLife's proprietary solvent-free melt fusion technology, a continuous processing system that eliminates the need for harmful organic solvents. Designed to precisely handle high-potency and hard-to-develop molecules, this platform significantly enhances formulation efficiency, safety, and scalability.   As a next-generation Contract Research, Development & Manufacturing Organization (CRDMO), STEERLife provides comprehensive development capabilities for complex and potent drugs - including NCEs, hormone therapies, orphan drugs, complex generics (ANDAs) and 505(b)(2) products, assisting global pharma in overcoming development and manufacturing challenges through process-driven innovation. "Potent drug development demands more than just compliance; it requires control, care, and innovation," said Indu Bhushan, CEO & Director at STEERLife. "Our continuous, solvent-free platform brings all of that together - enabling faster, cleaner and more scalable development for the world's most demanding therapies." STEERLife has already initiated the development of several key drug products set for market release from 2026 onwards. These include generic versions of ERLEADA® (Apalutamide), XTANDI® (Enzalutamide), VENCLEXTA® (Venetoclax), and LYNPARZA® (Olaparib), reflecting the company's ability to take on complex, high-barrier drug programs with confidence. Working in tandem with partner facilities, STEERLife is strategically positioned to serve leading pharmaceutical markets across the United States, Europe, Latin America, Russia, MENA and Southeast Asia. ]]> https://biospectrumindia.com/news/97/26104/piramal-pharma-invests-90m-for-expansion-of-two-us-sites.html https://biospectrumindia.com/news/97/26104/piramal-pharma-invests-90m-for-expansion-of-two-us-sites.html Tue, 13 May 2025 00:00:00 +0530 Mumbai-based Piramal Pharma Limited, a leading global pharmaceuticals and wellness company, in conjunction with the 2025 SelectUSA Investment Summit, has committed to a $90 million investment plan towards expanding two of the company's US facilities. These expansions are in response to ongoing demand from US customers, in support of the trend towards US onshoring of drug supply, and in line with Piramal Pharma's overall belief in the value and benefits of US-based innovation. In both cases, Piramal Pharma is making brownfield expansions to existing sites, financed by bank loans and internal accruals, which is the fastest, lowest risk, and most economical way to add new capacities to the US market. Piramal Pharma's Lexington, Kentucky, facility specialises in sterile compounding, liquid filling, and lyophilisation for sterile injectable drug products. The site's expansion which includes 24,000 square feet of manufacturing space and a new laboratory adds commercial-scale manufacturing that will enable the efficient scale-up of clients' injectable drug products. Key additions include a new filling line, two commercial-size lyophilisers, a special capping machine, and an external vial washer. The facility is expected to be completed and online by late 2027. While Piramal Pharma's Riverview, Michigan site, has earned a reputation as an industry leader in the development and manufacturing of active pharmaceutical ingredients (APIs) and high potency APIs (HPAPIs) over the past 50+ years. Here, the company is adding a commercial-scale suite specifically for the development and manufacturing of payload-linkers. These high potency APIs are used in the development of antibody-drug conjugates (ADCs) and other bioconjugate drugs. The new payload-linker suite is expected to be operational before the end of 2025. "Since its inception, Piramal Pharma Ltd has invested $570 million in its US drug development and manufacturing capabilities," said Peter DeYoung, Chief Executive Officer, Global Pharma. "The US is our largest market, where we currently employ approximately 750 people. Expanding the capacities and offerings in these two plants in the US, along with the prior major investments made in our Sellersville PA drug product facility, and our inhalation anesthesia drug substance and drug product facility in Bethlehem PA, will support our customers who value our offerings in an onshore setting." ]]> https://biospectrumindia.com/news/97/26086/akums-patented-tablet-in-tablet-technology-brings-relief-for-expectant-mothers.html https://biospectrumindia.com/news/97/26086/akums-patented-tablet-in-tablet-technology-brings-relief-for-expectant-mothers.html Tue, 06 May 2025 00:00:00 +0530 Akums Drugs & Pharmaceuticals, one of India’s leading pharmaceutical contract research and manufacturing organisation (CDMO), has been granted a patent for its breakthrough extended-release formulation of Doxylamine and Pyridoxine, designed specifically to address Nausea and Vomiting in Pregnancy (NVP). Nausea and vomiting of pregnancy (NVP) is one of the most common conditions experienced by expectant mothers, affecting up to 80% of women to varying degrees. While many women find relief by the 16th week, about 20% continue to suffer throughout their pregnancy. NVP can significantly disrupt daily routines, nutrition, and overall well-being. In response, Akums has developed a ground-breaking patented formulation that offers a solution designed to provide longer-lasting relief. This innovation marks a significant step forward in addressing a longstanding gap in maternal healthcare, offering much-needed support to those impacted by this common pregnancy challenge. This unique dosage form combines an outer layer that provides immediate drug release for rapid relief from nausea, with an inner core designed for sustained release, ensuring a longer therapeutic effect. The outer layer provides rapid relief from nausea, while the inner core maintains a prolonged action, reducing the need for frequent dosing. By combining immediate and sustained release in a single tablet, this dual-action design not only improves treatment outcomes but also enhances patient compliance, an essential factor in pregnancy care where safety, simplicity, and consistency are critical. Following a rigorous bioequivalence study and successful approval from the Drug Controller General of India (DCGI), the extended-release formulation stands validated in terms of efficacy and safety.    ]]> https://biospectrumindia.com/news/97/26023/dhl-express-and-sai-life-sciences-ink-partnership-to-make-pharma-deliveries-more-sustainable.html https://biospectrumindia.com/news/97/26023/dhl-express-and-sai-life-sciences-ink-partnership-to-make-pharma-deliveries-more-sustainable.html Tue, 22 Apr 2025 00:00:00 +0530 DHL Express, the world’s leading international express service provider, has partnered with Sai Life Sciences, an innovator focused global contract research, development and manufacturing organization (CRDMO) to use DHL’s emission-reduced shipping solution - GoGreen Plus (GGP). The partnership provides Sai Life Sciences with a greenhouse gas emissions reduction of up to 90% for its international logistics needs by using SAF. Sai Life Sciences works with over 300 global innovator pharma and biotech companies to accelerate the pace of their drug discovery, development and commercialisation. R.S Subramanian, Senior Vice President – South Asia, DHL Express, said, "Addressing Scope 3 emissions is critical to DHL for achieving the commitment to be carbon neutral by 2050. GoGreen Plus is a pioneering service that helps our customers address Scope 3 carbon emissions of their critical shipments to global destinations. The Life sciences and healthcare sector is a focus area for growth outlined in our Strategy 2030 and GoGreen Plus is very relevant to key players here who have a committed road map on carbon footprint reduction." Sivaramakrishnan Chittor,  CFO, Sai Life Sciences added, “Sustainability is a priority woven into every part of our business — including logistics. With a global supplier network and customer base across the US, Europe, and Japan, time-sensitive deliveries are essential to our operations."   Sai Life Sciences will implement GoGreen Plus across its key international shipping routes, reinforcing its ESG priorities and sustainability roadmap. This partnership marks another milestone in DHL Express’ mission to drive sustainable logistics solutions and support customers in their decarbonisation journey.   ]]> https://biospectrumindia.com/news/97/25929/sai-life-sciences-sets-up-peptide-research-centre-in-hyderabad.html https://biospectrumindia.com/news/97/25929/sai-life-sciences-sets-up-peptide-research-centre-in-hyderabad.html Thu, 03 Apr 2025 00:00:00 +0530 Sai Life Sciences Limited, an innovator-focused Contract Research, Development, and Manufacturing Organization (CRDMO), has inaugurated a dedicated Peptide Research Centre at its integrated R&D Campus in Hyderabad. Announcing the launch, Krishna Kanumuri, CEO & Managing Director, Sai Life Sciences, said: “As the pharmaceutical industry evolves from small molecules to emerging modalities like peptides, we are expanding our capabilities to stay ahead. Our new Peptide Research Center reflects this commitment, designed to meet the growing demand for complex peptide synthesis and conjugation. With this investment, we reinforce our role as a trusted partner in advancing next-generation therapeutics.” The Peptide Research Centre is designed to support innovator pharma and biotech companies with specialised services across peptide synthesis, discovery, and advanced modalities, including complex conjugates. The facility integrates automation, advanced liquid handling, robotics, and high-throughput systems, enhancing precision, scalability, and efficiency in the development of novel peptide-based therapeutics. Maneesh Pingle, Head of Discovery Services, said: “The demand for peptide-based therapeutics is rising rapidly, driven by their high specificity, biocompatibility, and lower risk of off-target effects." The new Peptide Research Centre will be integrated with Sai Life Sciences’ end-to-end discovery services, spanning synthetic and medicinal chemistry, biology, DMPK, and toxicology. This holistic approach ensures seamless transitions across different stages of drug discovery, accelerating timelines and enhancing success rates for peptide-based drug development. ]]> https://biospectrumindia.com/features/97/25891/industry-leaders-drive-crdmo-reform-unite-under-ipso-for-a-transformational-leap.html https://biospectrumindia.com/features/97/25891/industry-leaders-drive-crdmo-reform-unite-under-ipso-for-a-transformational-leap.html Mon, 31 Mar 2025 00:00:00 +0530 India’s Contract Research, Development, and Manufacturing Organization (CRDMO) sector is at a turning point. With immense potential for growth, it is emerging as a hub of innovation and opportunity. However, one major challenge persists—a lack of a clear and unified industry definition. This ambiguity is slowing progress, prompting industry leaders to push for decisive action. Recognising this need, experts are advocating for a dedicated industry panel to address key challenges and shape policies that will drive the sector forward. During a recent panel discussion, leaders emphasised the urgency of creating a strategic blueprint—a roadmap to define the CRDMO sector and position India as a global leader in biopharma outsourcing. Seizing the moment at BioAsia-2025, industry leaders announced the formation of the Innovative Pharmaceutical Services Organization (IPSO)—a dedicated industry body uniting 11 leading CRDMO companies. This strategic alliance is set to accelerate India’s dominance in biopharma innovation, ensuring a stronger, more structured future for the sector.   Role of IPSO With expertise spanning drug discovery, development, bio-manufacturing, and process innovation, IPSO aims to foster industry collaboration, strengthen policy advocacy, and enhance India’s regulatory and supply chain infrastructure. Industry leaders emphasize that India’s CRDMO sector, currently valued at $3-3.5 billion, has the potential to scale up to $22-25 billion by 2035, driven by the global shift in pharma outsourcing, rising demand for biologics, and India’s established strengths in chemistry and process innovation. However, industry leaders felt that achieving this ambitious growth requires overcoming key challenges, including streamlining regulatory pathways, improving access to capital, developing a specialised talent pool, and strengthening supply chain resilience. In view of all these challenges, IPSO is set to play a pivotal role in addressing the gaps, ensuring India emerges as a preferred global destination for pharmaceutical R&D and advanced manufacturing.   Collective action Industry experts revealed that IPSO will serve as a platform for advocacy, policy engagement, and industry collaboration, driving the next wave of biotech and pharmaceutical growth. "The Indian CRDMO sector is positioned for major transformation, with the potential to become a leader in serving the global biopharma and wider life sciences outsourcing market models. Realising this opportunity will require change and collaboration among all stakeholders in the Indian CRDMO ecosystem," stated Peter Bains, CEO Designate, Syngene International Ltd.  Manni Kantipudi, CEO and Whole Time Director, Aragen Life Sciences Ltd., echoed this sentiment, emphasising the need to scale capabilities in new modalities and build a resilient supply chain.    The Boston Consulting Group (BCG)’s Managing Director & Partner in the Healthcare practice, Vikash Agarwalla emphasised the importance of collective action from both industry and policymakers, stating that unlocking the sector's full potential will require a combined effort. Smruthi Suryaprakash, a partner from BCG, added that Indian CRDMOs must aggressively expand capabilities in high-growth areas like biologics and gene therapies, while addressing regulatory bottlenecks and scaling talent development.    Stress on Policy  Many industry leaders, including Peter Bains (Syngene), Manni Kantipudi (Aragen), Krishna Kanumuri (Sai Lifesciences), Nandini Piramal (Piramal Pharma), and Ramesh Subramaniam (PI Health Sciences), Guilano Perfetti (Jubilant Biosys), and Akhil Ravi (Aurigene Pharmaceutical Services) among others who were part of a panel discussion stressed on a unified industry definition, strategic workforce development, and a policy-driven roadmap to unlock the full potential of India’s CRDMO sector. As IPSO takes charge, the industry is now positioned to drive breakthrough innovations in emerging modalities like ADCs, RNA therapeutics, and cell & gene therapies, paving the way for India’s rise as a global life sciences powerhouse.   India's CRDMO Sector Poised to grow at $25 Billion by 2035 During a panel discussion industry experts revealed that India is witnessing a transformative era for the CRDMO sector, with projections indicating a potential surge to $22-25 billion by 2035.  Revealing details from a recent report, "Unleashing the Tiger: Indian CRDMO Sector 2025," published by BCG noted that India is strategically positioned to become a global leader in pharmaceutical innovation. This report reveals that India's established prowess in small molecule capabilities coupled with its sustainable cost advantages and burgeoning expertise in biologics, is attracting significant attention from global pharmaceutical giants seeking to diversify and secure their supply chains. The report also revealed that India's CRDMO market is experiencing a remarkable 15 per cent compound annual growth rate (CAGR), significantly outpacing global industry averages. This robust growth is fueled by several key factors. Notably, India maintains a significant cost advantage over Western nations, which enables faster project startup times and reduced overall development expenses.  Furthermore, it also highlighted that the global supply chain realignments, driven by geopolitical uncertainties and the desire for resilience, are unlocking a substantial $10 billion opportunity for Indian CRDMOs.  Adding to this, the Western pharmaceutical companies which are actively seeking alternative destinations and hubs to mitigate risks and ensure uninterrupted supply, India is rightly positioned to capitalise on their requirements.  Moreover, the rapid growth of new modalities, such as Antibody Drug Conjugates (ADCs), DNA & RNA therapeutics, and cell and gene therapies, presents a significant opportunity for India to leapfrog in innovation, as these advanced modalities are witnessing annual growth rates of 25-35 per cent, demanding specialised CRDMO services that India is increasingly equipped to provide.  The Indian government's commitment to fostering a self-sufficient, innovation-driven ecosystem is evident in substantial funding initiatives, with over Rs 25,000 crore allocated to support biotech and pharmaceutical innovation. While India currently holds a 2-3 per cent share of the $140-145 billion global CRDMO market, its potential for growth is immense, as the confluence of favourable factors positions India to become a dominant player. Global pricing pressures and policies like the US Inflation Reduction Act are accelerating off-shoring, further driving demand for cost-effective CRDMO services. Additionally, growing investments in research and development, coupled with infrastructure enhancements, are strengthening India's innovation capabilities.   Talent Gap and Fostering Scientific Curiosity Industry leaders voiced concerns over talent acquisition in the CRDMO sector, despite India’s abundant knowledge pool. The industry requires 12,000–15,000 additional chemists in the next five years, highlighting an urgent talent gap. “Quality is as crucial as quantity. Though India produces 50,000 chemistry postgraduates annually, they need proper training,” said Dr Ramesh Subramaniam, Global CEO of PI Health Sciences Ltd, United States. Akhil Ravi, CEO of Aurigene Pharmaceutical Services (a fully owned subsidiary of Dr. Reddy's Laboratories) emphasised immediate strategic intervention. He advocated industry-government collaboration to establish finishing schools for industry-specific training. Some firms have also launched in-house training universities to ensure a skilled workforce. Krishna Kanumuri, MD & CEO of Sai Lifesciences India, stressed the need to revive scientific curiosity, hindered by an execution-focused industry. Encouraging innovation, techniques like flow chemistry, and promoting research careers from the 12th grade were seen as crucial long-term solutions, including attracting Indian scholars back from abroad.   Strengthening International Partnerships  Giuliano Perfetti, CEO & MD, Jubilant Biosys Ltd, Italy emphasised the importance of international collaboration, particularly with Europe. "European companies are actively seeking alternatives to China, presenting an opportunity for deeper engagement with India’s CRDMO sector." However, he stressed the need for India to "ensure compliance with global quality and Health, Safety, and Environment (HSE) standards." Regulatory alignment between India and Europe was deemed essential for fostering long-term investment and collaboration.   Capital Deployment  India’s CRDMO sector faces a significant capital deployment gap compared to China. Dr Ramesh Subramaniam emphasised the urgent need for increased investment, highlighting that a single CRDMO in China deploys more capital annually than most of the Indian industry combined. To unlock its full potential, India's capital deployment must increase 4-5 times over the next decade. For the industry to scale in line with market opportunities, it must grow 5-10 times its current size. Given the capital-intensive nature and long life cycles of pharmaceutical development, investors must adjust their return expectations. However, India’s high cost of capital remains a challenge, necessitating financial innovations to improve capital efficiency. Beyond capital, the sector faces multiple hurdles that must be addressed for sustainable growth. By 2035, India requires a 6-7 times expansion of its talent pool, necessitating industry-ready curricula and upskilling initiatives. Streamlining regulatory approvals and establishing a CRDMO-focused framework are crucial to accelerating drug development and attracting investments. Strengthening the supplier ecosystem by incentivizing local manufacturers and setting up Innovation Parks can reduce import reliance. Industry experts suggest that designating CRDMO as a “sunrise sector” would improve capital access and attract private investment. Coupled with strategic investments, policy interventions, and global partnerships, India can emerge as a global CRDMO hub, driving economic growth, job creation, and pharmaceutical leadership.   Raw Material Divide Another critical challenge lies in raw material sourcing. Akhil Ravi pointed out, "Due to regulatory challenges and historical limitations, India lacks certain critical raw materials.” Overcoming this requires developing safe and efficient processes for hazardous chemistry and leveraging the country's robust oil and gas sector. "Government support in the form of grants and incentives, similar to China’s biotech funding, could accelerate progress," he suggests. This call for strategic government intervention highlights the need for a collaborative approach to enhance domestic manufacturing. Underscoring the proactive stance of industry leaders in tackling critical issues, he said, "We've recognised the challenges faced by the CRDMO sector and have come together independently to address them by taking it to the government and the policy makers.”   Road Ahead Industry leaders highlighted that academia plays a crucial role in addressing the talent shortage in India’s CRDMO sector, with nearly 70 per cent of professionals holding PhDs. However, private universities remain underutilised. Dr Subramaniam highlights the need for stronger industry-academia collaboration to integrate graduates into the workforce. Salary expectations remain a challenge, requiring competitive entry-level packages and hands-on training initiatives to attract top talent. It was also stressed that government policies also play a key role in accelerating growth. Peter Bains stresses the need for regulatory reforms to reduce bureaucratic hurdles and improve business efficiency. Establishing a CRDMO park, similar to SEZs (Special Economic Zones), could streamline approvals and facilitate global trade. Attracting international talent and re-shoring critical technologies remain key concerns. Industry leaders also discussed investment trends and supply chain diversification. Nandini Piramal, Chairperson of Piramal Pharma Ltd, noted the uncertainty surrounding the Biosecure Act, while Krishna Kanumuri highlighted differing investor expectations. Peter Bains revealed that Rs 2,000 crore has been invested in the sector over three years, emphasising the need for continued funding to attract global customers. Despite geopolitical challenges, India’s emerging supply chains present a sustainable opportunity. Overall, the experts agree that industry collaboration, policy reforms, and talent development are critical to positioning India as a global CRDMO hub.   Amguth Raju ]]> https://biospectrumindia.com/news/97/25901/akums-paving-way-for-greener-future-with-rooftop-solar-power-plant.html https://biospectrumindia.com/news/97/25901/akums-paving-way-for-greener-future-with-rooftop-solar-power-plant.html Thu, 27 Mar 2025 00:00:00 +0530 Contract development and manufacturing organisation (CDMO) Akums is making a large stride towards a greener and more sustainable tomorrow. Akums has successfully installed a 600 kWp on-grid rooftop solar power plant on its warehouse premises in Haridwar, Uttarakhand. The grid-connected solar panel, placed across a 56,000 sq. ft. region on the rooftop, is anticipated to produce more than 7.5 lakh units of solar power each year, according to calculations of trapping sunlight for 5 hours daily. With this project, the company can save over ₹50 lakhs on electricity usage per annum, amounting to huge savings on energy expenditure while preserving the environment. The environmental footprint of this initiative is high. Using the energy produced by solar power, Akums will be conserving the equivalent of over 10,000 trees per year, emphasizing its mission for sustainability and minimizing dependence on conventional energy resources. Through this solar power plant and generation of clean energy, Akums will lower its carbon footprint and lead the mission for renewable energy, further establishing the company's commitment to environmental stewardship. At the inauguration ceremony, the Managing Director and Founder of Akums Drugs & Pharmaceuticals Limited, Sandeep Jain said, “The successful commissioning of our rooftop solar power plant is a significant step towards our path to sustainability. This project will assist in lowering energy expenses, reducing our carbon footprint, and promoting a greener tomorrow. Akums continues to be committed to embracing green practices in our operations and helping India achieve its sustainability objectives.” This project is a key milestone for Akums as it continues on its journey to make the world cleaner and greener. By adopting renewable energy, Akums is not only lessening its ecological footprint but also setting an example in promoting sustainability for the next generation. ]]> https://biospectrumindia.com/news/97/25844/shilpa-biologicals-inks-strategic-agreement-with-mabtree-biologics-for-a-novel-immuno-oncology-asset.html https://biospectrumindia.com/news/97/25844/shilpa-biologicals-inks-strategic-agreement-with-mabtree-biologics-for-a-novel-immuno-oncology-asset.html Mon, 17 Mar 2025 00:00:00 +0530 Swiss firm mAbTree Biologics AG has signed an exclusive co-development and commercialisation partnership with Shilpa Biologicals (a fully owned subsidiary of Raichur-based Shilpa Medicare) for its novel biologic asset [a checkpoint inhibitor] for immuno-oncological applications. Under the terms of the strategic agreement, Shilpa Biologicals will support both development – including clinical studies – as well as long-term commercial supply with GMP manufacturing. Additionally, Shilpa Group will provide mAbTree access to India and several global markets through its extensive partner network. This programme aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation and generation of strong immune responses against tumours akin to the well-established PD-1/PD-L1 blockade.  While PD-1/PD-L1 blockade has demonstrated remarkable clinical successes, recent studies suggest our novel target has as a highly attractive therapeutic potential in various immuno-oncological states both as a monotherapy and combinatorial therapy. This approach has the potential to convert cold tumours (poor immune cell infiltration) hot (good immune infiltration), suppress tumour metastasis and make the refractory tumors susceptible to chemotherapy as well and is applicable in various cancers, including lung cancer, head and neck squamous cell carcinoma, and hematologic malignancies. Shilpa Biologics will utilise its large R&D teams – providing full-service capabilities from cell line development to GMP drug product manufacturing – with manufacturing and clinical supply conducted at its state-of-the art bio manufacturing facility at Dharwad, Karnataka. Commenting on the co-development deal and its potential impact on patients, Dr Sridevi Khambhampaty, CEO, Shilpa Biologicals said, “This novel therapy represents a new frontier in immuno-oncology, with the potential to expand treatment for patients who do not benefit from current immunotherapy options – so it’s potentially a massive breakthrough.” “Our aim is to enable greater access to medicines for more patients across the world, especially focusing on India and ROW markets where access has been limited”, added Raj Andhuvan, CEO, mAbTree.   Image caption- Dr Sridevi Khambhampaty, CEO of Shilpa Biologicals, and Raj Andhuvan, CEO of mAbTree ]]> https://biospectrumindia.com/news/97/25815/shilpa-medicare-launches-new-full-service-hybrid-cdmo.html https://biospectrumindia.com/news/97/25815/shilpa-medicare-launches-new-full-service-hybrid-cdmo.html Tue, 11 Mar 2025 00:00:00 +0530 Raichur-based Shilpa Medicare has launched its new full service ‘hybrid’ contract development and manufacturing organisation (CDMO). The newly formed CDMO will see Shilpa serve both small and large molecules customers as well as peptides – with oncology a particular therapeutic specialism.   In addition to offering comprehensive discovery, clinical, and commercial outsourcing services, Shilpa's ‘hybrid CDMO model’ also includes commercially ready ‘off-the-shelf’ novel formulations for exclusive b2b licensing.   This dual approach enables pharmaceutical companies to leverage Shilpa’s extensive expertise in oncology without the direct risks and lengthy timelines associated with development.   The CDMO currently has multiple assets in its pipeline and three late-stage products available for licencing at Drug, Chemical & Associated Technologies Association (DCAT). Through this model, pharma companies can expedite their market entry by licensing fully developed products while still benefiting from Shilpa’s robust development and manufacturing capabilities.   Commenting on the business realignment and hybrid model, Vishnukant C. Bhutada, Managing Director of Shilpa Medicare, commented, “Our goal is to offer pharmaceutical and biotech customers multiple flexible pathways to bring commercial products to market. On the one hand, they can leverage our development teams, cutting-edge technologies, and world-class facilities in a traditional CDMO partnership – with both our GLP-1 and biologics services in high demand at DCAT. On the other, we have a pipeline of fully developed products that are available for exclusive licensing, eliminating development risks for our partners. However, we remain strictly a b2b-only company, ensuring we never compete with our clients.”   Shilpa Medicare has seen rapid growth in recent years, achieving a turnover of over $150 million. The company is well-positioned to capitalise on the increasing trend of pharmaceutical outsourcing to India, offering an extensive infrastructure with five state-of-the-art R&D centres and six manufacturing facilities.     ]]> https://biospectrumindia.com/news/97/25771/senores-pharmaceuticals-begins-operations-at-greenfield-api-facility-in-mehsana.html https://biospectrumindia.com/news/97/25771/senores-pharmaceuticals-begins-operations-at-greenfield-api-facility-in-mehsana.html Fri, 28 Feb 2025 00:00:00 +0530 Senores Pharmaceuticals Limited has inaugurated and commenced manufacturing activities at its greenfield Active Pharmaceutical Ingredient (API) plant located at Mehsana, Gujarat.   Spread across approximately 230,000 sq. ft. with an installed capacity of ~100 Metric Tons per Annum, this is Senores' second API manufacturing facility, adding significantly to the existing API manufacturing capabilities.   Commenting on the inauguration, Swapnil Shah, Managing Director, Senores Pharmaceuticals Limited said, Commissioning of this API facility will help Senores broaden its offerings and strengthen its competitiveness in the Regulated Markets, especially in the CDMO/CMO business."   Recently, Senores also acquired the USFDA-approved Abbreviated New Drug Application (‘ANDA’) for Roflumilast 250 mcg and 500 mcg tablets from Breckenridge Pharmaceutical, Inc., strengthening its presence in the US generic pharmaceutical market. The acquisition, funded through the IPO proceeds, aligns with the company's strategic growth initiatives.   The companies’ current portfolio includes 24 ANDA and 21 CMO/CDMO commercial products that are permitted for distribution in the USA.    Senores has 2 manufacturing facilities for formulations– one in Atlanta, US which is USFDA approved and DEA/BAA compliant & other is in Chhatral, Ahmedabad, approved by WHO-GMP to cater to emerging markets. The company also has 2 manufacturing facilities for API in India, both located around Ahmedabad, with one in Chhatral and the other in Naroda. Senores has strong R&D capabilities to drive differentiated product portfolio across 3 R&D sites (1 in the USA and 2 in India). ]]> https://biospectrumindia.com/news/97/25733/motilal-oswal-alternates-invests-rs-460-cr-in-megafine-pharma.html https://biospectrumindia.com/news/97/25733/motilal-oswal-alternates-invests-rs-460-cr-in-megafine-pharma.html Tue, 25 Feb 2025 00:00:00 +0530 Motilal Oswal Alternate Investment Advisors Private Limited (MO Alts) has agreed to invest upto Rs 460 crore for a majority stake in Mega Fine Pharma Private Limited. The Sanghvi Family, one of the founding-promoter groups, has also participated in this transaction, increasing their stake in the company. Megafine is a Mumbai based export focused API company with two USFDA approved manufacturing facilities in Nashik and Vapi. The company specialises in the manufacture and sale of a diverse range of high-value, low-volume niche Active Pharmaceutical Ingredients (APIs) for chronic therapies. Established in 1995, Megafine is backward integrated to manufacture its own intermediates while also offering contract manufacturing services for APIs and Intermediates to third-party customers. The company has long-standing relations with leading global pharmaceutical companies and has achieved global market leadership in some of its key APIs.  Shailesh Sanghvi, Founder, Promoter and now Managing Director of Megafine stated, “Our focus remains on delivering high-quality products as an independent API supplier in specialized and niche segments. With our manufacturing facilities approved by all major global regulatory authorities, we are committed to excellence. We look forward to partnering with the MO Alts’ team as we embark on the next stage of growth." Rohit Mantri, Managing Director and Co-Head of Private Equity at MO Alts commented, “India’s API industry is witnessing a double-digit growth, driven by increased outsourcing, lower costs and de-risking of global supply chains from China. This is our first sole control investment as MO Alts and we would focus on further strengthening R&D and manufacturing capabilities and creating a platform for further inorganic opportunities." Megafine and its shareholders were advised by Deloitte (financial advisor), JSA (legal) & Pioneer (legal) on the Transaction. Quillon Partners (legal), Alvarez and Marshall (financial), PWC (tax) & MP Advisors (commercial) advised MO Alts. ]]> https://biospectrumindia.com/news/97/25735/eleven-crdmos-collaborate-to-form-dedicated-industry-body-ipso.html https://biospectrumindia.com/news/97/25735/eleven-crdmos-collaborate-to-form-dedicated-industry-body-ipso.html Tue, 25 Feb 2025 00:00:00 +0530 In a step toward advancing Indian Contract Research, Development, and Manufacturing Organization (CRDMO) sector, eleven of the country’s leading CRDMO companies have come together to launch a dedicated industry body called Innovative Pharmaceutical Services Organization (IPSO), bringing together diverse expertise in discovery, development, biomanufacturing, and other specialized areas. The eleven CRDMO companies include Syngene, Aragen, Anthem Biosciences, Aurigene, Laxai, Piramal Pharma, Neuland, Sai Life Sciences, TCG Lifesciences and O2H Discovery. This collective initiative aims to advance India’s CRDMO sector and is dedicated to fostering pharmaceutical and healthcare innovation in India, that supports research, policy advocacy and industry collaboration to drive the next wave of biotech and pharma growth. A new report, Unleashing the Tiger: Indian CRDMO Sector 2025, published by Boston Consulting Group (BCG) and Innovative Pharmaceutical Services Organization (IPSO) at the ongoing BioAsia 2025 event in Hyderabad, states that the Indian CRDMO sector is at an inflection point, with the potential to grow to $22 - $25 billion by 2035. The report also reveals that India’s CRDMO sector must overcome five key challenges to sustain growth. It needs a 6-7x talent expansion by 2035, faster regulatory approvals and a stronger tier 1 supplier base to reduce import reliance. Limited funding and high capital costs hinder the 4-5x investment needed, while ESG compliance still lags behind Western peers. Peter Bains, CEO Designate, Syngene International Ltd. said, "The Indian CRDMO sector is positioned for major transformation, with the potential to become a leader in serving the global biopharma and wider life sciences outsourcing market models. Realizing this opportunity will require change and collaboration among all stakeholders in the Indian CRDMO ecosystem. We will also need to work with and collaborate with the Government to foster a more competitive regulatory and financial ecosystem in India to compete with other geographies. We will need to work with India’s academic ecosystem to ensure a strong flow of highly talented scientists, engineers and technology leaders to ensure we are capability competitive. Only by working together, can we unlock new opportunities in drug discovery, process innovation, and advanced manufacturing, that can strengthen India’s position in the global pharmaceutical value chain." Manni Kantipudi, CEO and Whole time Director, Aragen Life Sciences Ltd., added, "The shift in global pharma outsourcing, the rapid rise of biologics, and India’s expertise in chemistry and process innovation create a once-in-a-generation opportunity. However, to compete at a global level, Indian CRDMOs must not only scale capabilities in new modalities like ADCs, cell & gene therapies, and RNA therapeutics but also work together to build a resilient supply chain and streamline regulatory pathways. IPSO is committed to driving this change by working closely with stakeholders to improve access to capital, accelerate talent development, and champion policy initiatives that make India an even more attractive destination for pharmaceutical R&D and manufacturing. As an industry, we must come together to shape the future of Indian life sciences and secure our place at the forefront of global innovation” ]]> https://biospectrumindia.com/news/97/25716/granules-india-enters-cdmo-business-by-acquiring-senn-chemicals-ag-for-rs-192-5-cr.html https://biospectrumindia.com/news/97/25716/granules-india-enters-cdmo-business-by-acquiring-senn-chemicals-ag-for-rs-192-5-cr.html Sat, 22 Feb 2025 00:00:00 +0530 Hyderabad-based Granules India has announced the signing of the acquisition agreement regarding Senn Chemicals AG, a Swiss-based CDMO specialising in peptides. Senn develops and manufactures, Peptides and Peptides based applications for its global customers, providing contract research, development, and manufacturing services. The closing of the acquisition, at the cost of Rs 192.5 crore, is subject to certain conditions. The closing is expected to occur in the first half of 2025. The acquisition brings Senn’s expertise in Liquid-Phase Peptide Synthesis (LPPS) and Solid-Phase Peptide Synthesis (SPPS), along with a strong CDMO business and established customer relationship, including innovators and brand owners across Pharma, Cosmetics, Amino Acid Derivatives (AAD) & theragnostic segments. This enables Granules’ acquiring capabilities into high-growth peptide- based therapeutics. The acquisition aligns with Granules’ vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market, including GLP-1 receptor agonists and other next-generation therapeutics. Granules and Senn have been developing two GLP-1 based APIs, and both the projects are progressing well, and more peptide-based APIs are planned to be added in the portfolio, to be developed using Senn’s R&D capabilities. The acquisition marks Granules foray into CDMO segments, leveraging Senn’s existing CDMO business and customer relationships, on back of its R&D and manufacturing platform. With this transaction, Granules will leverage Senn’s European presence and innovation-driven peptide platform to accelerate its CDMO expansion and meet the fast-growing demand for Amino Acid Derivative (AAD), peptide fragments, and peptide-based therapeutics. Senn presence in Europe, provides access to a skilled R&D talent pool and regulated market clients, further strengthening Granules’ global footprint. ]]> https://biospectrumindia.com/news/97/25687/iscrs-18th-annual-conference-highlights-innovation-technology-and-patient-centricity.html https://biospectrumindia.com/news/97/25687/iscrs-18th-annual-conference-highlights-innovation-technology-and-patient-centricity.html Mon, 17 Feb 2025 00:00:00 +0530 Indian Society for Clinical Research (ISCR), an association of clinical research professionals, hosted its 18th Annual Conference at CIDCO Exhibition & Convention Centre, Vashi, Navi Mumbai on January 31 and February 1, 2025. Marking two decades of advancing clinical research in India, ISCR also celebrated its 20-year journey at the event. The conference welcomed participation from over 2100 delegates and featured 300 eminent speakers. It brought together a diverse group of experts to discuss key themes, including advancements in patient-centric approaches in clinical trials, ethics, artificial intelligence, innovations in data management, statistical reporting, medical writing, programming, and increased academic participation in research. All discussions revolved around the central theme: "Enhancing India’s Success in Clinical Research: Unifying Innovation, Technology, and Patient Centricity." A key highlight of the conference was the launch of ISCR’s Artificial Intelligence (AI) and Machine Learning (ML) paper during the inaugural session, highlighting the growing impact of AI and ML in clinical research. Dr Santosh Kadam, President of IMA Maharashtra, emphasised the importance of innovation and addressing unmet medical needs during his inaugural address. He highlighted how clinical research plays a pivotal role in ensuring that new medicines, vaccines, diagnostics, and devices are thoroughly tested for safety and efficacy. Prominent industry thought leaders and experts like Dr. Arijit Nag (Tata Memorial Center), Dr Rahul Purwar (IIT Mumbai), Dr Ganesh Dakhle (AIIMS, Nagpur), Dr Kshitij Jadhav (IIT Mumbai), Dr Anant Patil (DY Patil Medical College, Nerul) etc. were part of sessions which discussed the evolving role of clinical research in healthcare. Other speakers at the event included representatives from leading R&D organisations such as Sun Pharma, Dr Reddy’s,  Biocon Ltd. as well as other multinational R&D organisations. They enriched the dialogue with valuable insights on cutting-edge technologies, innovative methodologies, and patient-centric approaches shaping the future of the sector. The conference also emphasised the importance of collaboration and innovation in enhancing clinical trial methodologies. Interactive sessions like “Revolutionising Dose Decision Making” and “Harnessing the Power of Statistics in Cancer Care” provided attendees with practical strategies for improving trial outcomes and patient-centric solutions. The event concluded with engaging panel discussions on preparing effective regulatory submissions and bridging data gaps using advanced statistical tools. Highlighting importance of clinical research in India, Dr Sanish Davis, President of ISCR, said, “The 18th Annual Conference exemplifies our commitment to advancing the discipline of clinical research in India by fostering collaboration and innovation. As methodologies like artificial intelligence, machine learning, decentralized trials, adaptive designs, and patient-centric approaches rapidly evolve, this platform enables meaningful discussions on integrating these advancements into the Indian clinical research ecosystem. Together with academia, regulators, innovation driven R&D organizations and patients, ISCR aims to push  the vision of Viksit Bharat to bring forth impactful healthcare solutions, prioritising both quality and accessibility." In its journey to becoming a global leader in clinical research, India’s evolving policy landscape continues to play a pivotal role in shaping the research ecosystem. With ongoing regulatory advancements, the country is well-positioned to foster innovation, enhance patient outcomes, and establish itself as a hub for cutting-edge discoveries, innovations and clinical trials. Beyond the conference, ISCR actively builds public awareness about clinical research. In 2024, ISCR's Run4Research engaged the public in discussions on its healthcare impact, reinforcing ISCR’s commitment to bridging knowledge gaps and fostering trust in clinical research. ]]> https://biospectrumindia.com/news/97/25622/akums-unveils-dual-action-therapy-for-diabetes-management.html https://biospectrumindia.com/news/97/25622/akums-unveils-dual-action-therapy-for-diabetes-management.html Mon, 03 Feb 2025 00:00:00 +0530 Akums Drugs and Pharmaceuticals, a leader in contract development and manufacturing, has launched Dapagliflozin + Pioglitazone tablets; an advanced combination therapy designed to tackle the growing challenge of diabetes management. While conventional treatments often fall short in maintaining stable blood sugar levels, this dual-action formulation offers a more potent solution for individuals struggling with existing metformin-based regimens. Approved by the Drugs Controller General of India (DCGI), it goes beyond glycemic control, overcoming broader obstacles associated with diabetes care. This dual-action therapy combines two complementary mechanisms of action. Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, aids in eliminating excess glucose via urine while delivering additional benefits such as improved cardiovascular and renal outcomes, along with better weight management. Pioglitazone, on the other hand, augments insulin sensitivity in key tissues, such as muscles and the liver, helping combat the root issue of insulin resistance. Together, they provide sustained results while minimising risks like hypoglycemia and weight gain, which are common hurdles in diabetes care.  Compared to monotherapy, this dual approach ensures more comprehensive blood sugar regulation by addressing multiple pathways simultaneously. While single-drug regimens may provide partial benefits, the combined action of Dapagliflozin and Pioglitazone offers superior control, reducing fluctuations in glucose levels more effectively. Moreover, dual therapy lowers the likelihood of treatment failure, ensuring long-term stability without necessitating frequent medication adjustments. Its once-daily dosing further enhances adherence, making diabetes management simpler and seamless for patients. Commenting on the launch, Sandeep Jain, Managing Director of Akums Drugs and Pharmaceuticals, stated, “The rise in diabetes cases in our country calls for novel and accessible solutions. By introducing Dapagliflozin + Pioglitazone tablets, we aim to equip healthcare providers with an advanced treatment option that caters to the diverse needs faced by patients."     ]]> https://biospectrumindia.com/features/97/25589/how-india-is-pulling-in-european-life-sciences-sector-.html https://biospectrumindia.com/features/97/25589/how-india-is-pulling-in-european-life-sciences-sector-.html Fri, 31 Jan 2025 00:00:00 +0530 The total global pharma market in calendar year 2023 was $1508 billion and is expected to touch $1544 billion in 2024 registering a growth of 2.4 per cent. North America, the leading region with an expected share of $511.79 billion in 2024 is likely to see an increase of 3.73 per cent over previous year’s share of $493.38 billion. Asia Pacific is the leading region in terms of percentage growth of 3.86 per cent in 2024 over the previous year’s growth rate of 3.14 per cent with a share of $467.04 billion in 2024 as against $449.69 billion in 2023 and $436 billion in 2022. The European region which recorded a growth rate of 4.95 per cent in 2023 with a share of $410.71 billion in 2023 will witness a flat growth in 2024 as its share will be around $410.71 billion, according to the IQVIA report. The global generic market that holds 32.65 per cent of the total pharma market as per Fitch Solutions has touched $492.78 billion in 2023. India is predominantly a generic player. Major generic producers in the world besides India, include China producing $100-110 billion, USA producing roughly $ 65-70 billion, Germany producing $ 20-22 billion, Russia producing $14-15 billion. India’s generic share in the global generic market is $ 44.78 billion ($21.53 billion exports + $23.25 billion domestic) working out to a percentage share of 9.2 per cent. India’s exports of pharmaceuticals during April 2023 till March 2024 has been to the tune of $27.84 billion with a growth of almost 9.66 per cent. The North American Free Trade Agreement (NAFTA), a trade agreement between the United States, Canada, and Mexico region continues to be the topmost region as an exporting partner for India with share of $9,569.52 million in financial year 2023-24 registering growth of 14.64 per cent over previous year’s share of $8,347.24 million. Exports to the region of Europe has grown by 11 per cent and is accountable for more than 20 per cent of India’s exports. Europe has a strong and robust pharma industry and in fact, it is the very crucible from which the global modern pharma industry has evolved. Considering this growth, 2371 pharma companies have received Certification of Suitability (CEP) from European regulatory authorities (as of April 2024) and 1943 pharma companies have got accreditation from UK MHRA (The Medicines and Healthcare products Regulatory Agency) and Market authorisations.  This progress has been witnessed due the strong relations between India and European Union (EU) that has a cooperation agreement with India dating from 1994, which allows the setting up of specialised subgroups, including on pharmaceuticals. In 2005, the EU and India adopted a joint action plan for the India-EU strategic partnership, endorsing the establishment of a working group on pharmaceuticals. This working group started its activities in July 2006, with annual meetings ever since.  The European Medicines Agency (EMA) supports India in applying international standards, particularly for good manufacturing practice (GMP) and clinical trial activities, and facilitates capacity building and regulatory contacts. Due to these activities, among the top 10 Indian pharmaceutical export destinations five are from the European region namely UK (second), Netherland (fourth), France (fifth), Belgium (seventh) and Germany (eighth).  Taking the advantage of these agreements at the government levels, the European companies have been investing in R&D and manufacturing facilities, as well as opening Centres of Excellence (CoEs) and Global Capability Centres (GCCs) in India. Through these approaches, leading European pharmaceutical and biopharmaceutical companies are actively expanding their footprint in India. Their strategies include fostering research and development (R&D), investing in Contract Research Organisations (CROs) and Contract Development Manufacturing Organisations (CDMOs), and establishing partnerships to enhance large-scale production capabilities. These collaborations focus on areas like healthcare innovation, digital health, biotechnology, vaccine production, biosimilars, and biologics manufacturing, essential for global healthcare resilience.  Many European companies have not only been sourcing products from Indian manufacturers for years, but have been now setting up their own production facilities in India. As many pharma companies turn to more collaborative business models, India having strong IT talent and skill sets in areas like artificial intelligence (AI), machine learning (ML), cloud computing, IoT, big data, analytics and many new areas is likely to play an increasingly important partnering role.   In July 2024, Sanofi, a French multinational pharmaceutical and healthcare company announced a €400 million ($437 million) investment in its GCC in Hyderabad, while Denmark's Novo Nordisk, in October 2024, partnered with AI startups and expanded its leadership team, planning an increase in its workforce by 2025 to handle vast clinical trial datasets. UK-based AstraZeneca is investing Rs 250 crore to expand its GCC in India, underscoring its commitment to leveraging India's talent pool and enhancing its global operations.  It may be noted that Sandoz, a Swiss company that focuses on generic pharmaceuticals and biosimilars and now the generics arm of Novartis, has two manufacturing plants and a research centre for developing formulations and processes, based in Thane. GlaxoSmithKline (GSK), a British multinational pharmaceutical and biotechnology company has facilities based in Mumbai and Nashik. The GSK operates in India through its subsidiary, GlaxoSmithKline Pharmaceuticals Ltd, offering a range of prescription medicines and vaccines across various therapeutic areas. GSK has a longstanding presence in India, contributing to the healthcare sector through its products and initiatives. Roche, the Swiss pharmaceutical firm has entered into promotion, marketing, and distribution partnerships with Indian companies Cipla and Entero. These collaborations aim to improve access to Roche's oncology, rheumatology, immunology, and nephrology medicines in India. Mid-tier global pharma companies are present as well – Lonza, and Ethypharm all have manufacturing or research facilities in India.    Healthcare Innovation and Digital Health  The rapidly expanding technological infrastructure in India is creating a strong base for enabling global pharma companies to enhance their operations, drive innovation, and achieve cost efficiencies, earning India a significant competitive advantage. The country's robust IT infrastructure supports various aspects of operations, including R&D, data management, and digital health initiatives.  For instance, Swiss giant Roche is harnessing India’s robust technology ecosystem to forge ahead in the digital landscape, crafting innovative solutions that resonate on a global scale. Roche has been actively collaborating with India's life sciences industry to enhance healthcare access and innovation.  Roche has expanded its digital pathology open environment through strategic collaborations aimed at supporting pathologists and scientists in cancer research and diagnosis by leveraging cutting-edge AI technologies. Roche initiated its first Digital Center of Excellence in India, in Pune early 2024 - a co-location for Roche Information Solutions, Roche Diagnostics Solutions R&D, and Roche Informatics teams encompassing a diverse team of professionals from data engineers and software engineers to architects and user-experience professionals working to build cutting edge products in digital healthcare. Roche Information Solutions India evolved from Roche’s 2017 acquisition of Viewics’, a startup with its engineering centre in Pune. To cite a similar example, AstraZeneca’s Global Innovation & Technology Centre (GITC) in Chennai drives the company's digital journey and technology innovation, housing over 50 per cent of its global IT staff. GITC offers services in software engineering, cybersecurity, IT infrastructure, cloud, hyper-automation, AI/ML, extended reality, and IoT. To this end, in July 2024, AstraZeneca India Private Limited (AZIPL), the GCC of AstraZeneca, announced an investment of Rs 250 crore ($30 million) to expand its GITC, which includes close to 1,300 roles focused on driving innovation, enhancing efficiency, and streamlining operations across the company globally. In July 2024, the Startup Incubation and Innovation Centre (SIIC), the technology business incubator of the Indian Institute of Technology Kanpur (IITK), entered into an agreement with Boehringer Ingelheim India, a leading global pharmaceutical company, to foster a partnership for fostering healthcare innovations. Boehringer Ingelheim’s grant supports Manastik Technologies, an SIIC-incubated startup focused on developing India's inaugural tele-neurorehabilitation app for multidisciplinary dementia care and diagnosis, focussing on the unmet need for comprehensive mental health strategies to address the growing burden of dementia and other mental health disorders in India. Using DADT (Dementia Application and Diagnosis & Tracking) technology, Manastik caters to the dementia ecosystem by providing those in need with personalised help curated by experienced doctors and neurohealthcare professionals. Boehringer has pledged a grant to Manastik to validate their app, raise awareness, and conduct dementia screening campaigns nationwide in India. Boehringer Ingelheim India has also signed an MoU with RED.Health ambulance services, the emergency care expert, to strengthen emergency pre-hospital stroke care services in India. This collaboration aims to advance emergency healthcare and support timely, life-saving medical interventions, advancing stroke care and adding value to the Stroke Care Eco-system in the country.  Bengaluru-based Ayush Hospital Soukya is set to embark on its first global expansion since its inception in 2002. Addressing the growing global demand for integrative medicine, Soukya will establish its first international unit in Portugal with an investment of Rs 220 crore. The state-of-the-art residential medical institute, expected to be operational by late 2027, will offer its unique treatment approach combining traditional, time-tested natural systems of medicine such as Ayurveda, Homeopathy, Yoga, Naturopathy, and other complementary therapies for treating various chronic and lifestyle conditions.    Biotechnology When we look at the biotechnology space, Merck Life Science in India has signed a Memorandum of Understanding (MoU) with GeNext Genomics, an emerging biotech company. This collaboration creates a unique competitive edge by combining local expertise with global biomanufacturing capabilities. By partnering with Merck for their world-class expertise in biomanufacturing, Genext Genomics can now offer comprehensive solutions that support the growth of India’s biotech ecosystem. Bengaluru-based SKAN Research Trust (SKAN), promoted by Indian entrepreneur Ashok Soota, has announced a joint research project with the UK-based Wellcome Sanger Institute and the University of Newcastle, to study early somatic mutations in blood stem cells that researchers believe drive several cancerous and non-cancerous conditions. SKAN Research Trust, and UK-based Quadram Institute Bioscience have announced a collaborative initiative to apply the cutting-edge TraDIS-Xpress platform to study the action of traditional medical compounds on bacteria, thereby aiding in the reformulation and development of novel antibacterial regimens. TraDIS-Xpress is Quadram’s proprietary genetic sequencing platform that is at the forefront of efforts to uncover new antimicrobial agents and develop better prebiotics and probiotics for health promotion.  On the other hand, in an innovative initiative aimed at propelling healthcare innovation forward, the Technology Development Board (TDB) from Department of Science & Technology (DST), Government of India has granted Rs 75 lakh to Peptris Technologies Pvt. Ltd. and the Foundation for Neglected Disease Research (FNDR), Bengaluru in March 2024 for a project "ANAGRANINF - Development of a Novel Class of Antibiotics Against Gram-Negative Bacterial-Infections." The project is a joint effort between Indian and Spanish companies, with ABAC Therapeutics Sl serving as the Spanish Project Lead. Miltenyi Biotec, a global biotechnology company headquartered in Germany  announced a few strategic collaboration/partnership plans aligning with the Indian industry last year. The German company partnered with the Faridabad-based Translational Health Science and Technology Institute (THSTI) in July 2024. This collaboration aims to enhance research and development in cell and gene therapy, focusing on cancer and sickle cell disease. The partnership encompasses capacity building, technology transfer, training programmes, and joint research initiatives to translate scientific advancements into medical therapies. Earlier in 2024, Miltenyi Biotec also signed an MoU with BIRAC, a public sector enterprise under the Department of Biotechnology (DBT). This agreement is designed to facilitate the development of chimeric antigen receptor (CAR) T-cell therapies and other CGT services in India.  The collaboration focuses on making advanced therapies more accessible and affordable by promoting local development and manufacturing, aligning with India's 'Made in India' initiative in the CGT sector. These strategic initiatives underscore Miltenyi Biotec's interests in advancing biomedical research and therapy in India through collaboration with local institutions and investment in state-of-the-art facilities. The company plans to catalyze the development of CAR T-cell therapies, with the prospect of implementing centralised and point-of-care CAR T-cell treatments across Indian hospitals. This initiative aligns with Miltenyi Biotec's goal to bring new therapies to patients with high unmet medical needs. These strategic initiatives underscore Miltenyi Biotec's dedication to fostering innovation and collaboration within India's life sciences sector, aiming to enhance healthcare outcomes through advanced cell and gene therapies. In October 2024, the International Centre for Antimicrobial Resistance Solutions (ICARS) from Denmark has signed a partnership with the Centre for Cellular and Molecular Platforms (C-CAMP), under the aegis of the India AMR Innovation Hub (IAIH), to address the growing threat of Antimicrobial Resistance (AMR) across the One Health spectrum. As part of this partnership, ICARS will provide funding support over the next five years, along with technical expertise and a network for implementation research in collaboration with C-CAMP, aligning with India’s National Action Plan on AMR (NAP 2.0). Additionally, ICARS and C-CAMP will work together to mobilise further funding to expand their efforts and create a wider impact. This collaboration can be deemed as a cluster-to-cluster collaboration, between the two independent research and knowledge centres.    CROs and CDMOs  Besides biotechnology, we witnessed partnerships between India and the EU in CRO and CDMO sectors during last year. Akums Group, a Delhi-based CDMO, has announced a strategic long-term agreement with a globally renowned pharmaceutical company to manufacture and supply pharmaceutical formulations in the European market. Under this collaboration, Akums Group will produce and supply multiple SKUs of oral liquid formulations, which the partner company will market across various European countries.  Veeda Lifesciences (earlier called Veeda Clinical Research), an Ahmedabad-based full-service CRO, has acquired Heads, a privately held European CRO, which specialises in conducting clinical trials in oncology. The acquisition provides Heads with a strong operational platform and an opportunity to expand its expertise and capabilities to the Indian and South-East Asian markets. India's diverse demographic profile provides a unique opportunity to conduct clinical trials, especially in therapeutic areas including oncology, diabetes, hypertension, infectious diseases, and special diseases. With this acquisition, Veeda’s global pharmaceutical and biotech clients can now leverage the unique and unparalleled suite of early to late-phase CRO services across Europe, the US, and Asia Pacific.  Piramal Pharma Solutions, the CDMO business under Piramal Pharma Limited (PPL), with operations in North America, Europe and Asia announced the opening of an expanded ADC manufacturing facility in Scotland; The commissioning of the facility represents the culmination of a £45 million investment.  Mumbai-based Blockchain-As-A-Service company Qila.io has partnered with global clinical research centre Mascot Spincontrol to bring about transparency in clinical research through blockchain. The collaboration aims to ensure that clinical trial data is secure, transparent, and tamper-proof so that the integrity of research outcomes is maintained. Mumbai-based Mascot Spincontrol is a clinical research centre formed through a joint venture between Mascot Universal and Spincontrol France. The European Company KrKA and Laurus Labs announced a joint investment of Rs 2000 crore in Genome Valley, a high-technology business district located in Hyderabad, for the establishment of finished pharmaceutical products and biopharmaceutical manufacturing in the cluster.  Roche has partnered with Cipla to promote, market, and distribute its oncology and rheumatology/immunology drugs in India. This collaboration aims to improve access to treatments for complex diseases. In collaboration with Entero, Roche focuses on the nephrology segment, ensuring wider availability of its nephrology drugs across the Indian market.   Vaccines The collaboration is not restricted to CRO and CDMO sectors, but externed to vaccine areas as well. France-based Valneva SE, a specialty vaccine company, and Pune-based Serum Institute of India (SII) announced an exclusive license agreement for Valneva’s single-shot chikungunya vaccine that enables the supply of the vaccine in Asia. The companies will work urgently to bring the vaccine to the Indian market, and certain other Asian countries, subject to local regulatory approvals. Under the agreement, the companies will conduct a technology transfer of the current drug product manufacturing process.  Besides, SII is joining a growing Coalition for Epidemic Preparedness Innovations (CEPI) network of vaccine producers in the Global South to support more rapid, agile, and equitable responses to future public health disease outbreaks. The addition of SII to the Norway-based CEPI manufacturing network will be a significant boost to vaccine production efforts in Global South regions and will mean the world is better prepared to achieve the 100 Days Mission to develop new vaccines against known or novel infectious diseases within three months of a pandemic threat being recognised. India’s global pharma leader Dr. Reddy’s Laboratories has entered into an exclusive partnership with Sanofi Healthcare India to promote and distribute their vaccine brands across private markets in India. Under the arrangement, Dr. Reddy’s will have exclusive rights to promote and distribute Sanofi’s well-established and trusted paediatric and adult vaccine brands Hexaxim, Pentaxim, Tetraxim, Menactra, FluQuadri, Adacel, and Avaxim 80U.    Academic research-driven collaborations The collaboration and partnerships are not restricted to firms but extended to research and academic institutions as well. Horizon Europe, the European Union's flagship research and innovation program for the period 2021-2027, designed to address global challenges and enhance Europe's competitiveness, has established several partnerships with Indian academic and research institutions to promote collaboration in life sciences. Joint projects are aimed to focus on developing rapid vaccine manufacturing pipelines, addressing AMR, and enhancing preparedness for future pandemics. The primary goals of Horizon Europe in the context of EU-India collaboration in life sciences include advancing healthcare research, enhancing researcher mobility and co-funding, and promoting joint research initiatives to tackle global health challenges, including disease prevention, diagnostics, and treatment.  Facilitating the exchange of researchers and innovators between the EU and India to foster knowledge sharing and capacity building is an important factor of the Horizon Europe initiative. For example, Indian researchers are eligible for Marie Skłodowska-Curie Actions (MSCA) fellowships, which support mobility and training for researchers at all career stages. This facilitates Indian researchers' participation in European research projects and vice versa. Indian institutions like Council of Scientific and Industrial Research (CSIR), DBT, and DST are participating in a co-funding mechanism to fund and develop joint research projects and healthcare innovation.   In August 2024, the CSIR in India and the European Union launched a co-funding initiative under the MSCA Staff Exchanges, part of the EU’s Horizon Europe programme. This scheme enables CSIR institutes to engage in joint research projects with European partners, facilitating the secondment of scientific and technical staff to European research organisations for knowledge-sharing and collaborative activities. The funding, available from 2025 to 2027, aims to promote balanced researcher mobility and foster long-term collaborations between India and Europe.  Initiated and funded by the French government, the 'Franco-Indian Campus in the Field of Life Sciences for Health' project brings together over 60 French and Indian universities, research institutions, labs, hospitals, startups, and corporates to jointly develop and deliver higher education and research programmes in life sciences for health. The campus aims to become a hub for cutting-edge research, development, and innovation across the 'One Health' paradigm, addressing global health challenges through a multidisciplinary approach. The initiative saw collaborations/partnerships in the past year including several notable Indian educational research institutes like IIT-Delhi, IISER, Asoka University, VIT Vellore, JIPMER Pondicherry, CIMAP Lucknow, NCBS, and  Indian Institute of Science (IISc), Bangalore. And, in a nutshell, these Indo-French collaborative initiatives based in the past one to two years, and continuing into the upcoming year aim to address societal needs and tackle global health challenges by advancing the training of individuals and fostering innovation -   Establish a multidisciplinary Franco-Indian virtual campus to address evolving societal needs by integrating research in fundamental biology with engineering, chemistry, physics, applied mathematics, bioinformatics, and social sciences. Tackle global health challenges, such as infectious diseases, neurodegenerative disorders, and cancers, through complex, multidisciplinary approaches encompassing genomics, neurosciences, ecology, and social sciences. Foster innovation via the ILIADE platform, which focuses on analyzing the pharmaceutical properties of plants using advanced techniques like artificial intelligence and offers specialized academic programs in medicinal plants and AI applications for health data. Advance research and training in molecular biology and therapeutic innovation by leveraging cutting-edge tools in bioinformatics and artificial intelligence. On similar lines, in November 2024, University College London (UCL) and the Indian Institute of Science (IISc), Bengaluru, launched a new phase of their strategic partnership to expand innovative work in healthcare. The collaboration focuses on co-creating significant new research capabilities in areas such as digital health, quantum technology, artificial intelligence, and medicine. The partnership includes plans for collaborative PhDs, faculty exchanges, and research fellowships, aiming to train future physicians and advance healthcare solutions.  A partnership between the European Molecular Biology Organisation (EMBO) and India’s DBT offers Indian researchers access to EMBO funding schemes, enhancing opportunities for the Indian scientific community. EMBO and DBT are conducting a nationwide dissemination exercise to raise awareness about these schemes. The CSIR has multiple exchange agreements with DAAD, Germany, enabling annual scientist visits and fostering collaboration.  India has bilateral Science & Technology (S&T) cooperation agreements with 83 countries, actively collaborating with 44 nations, including the EU, France, Germany, and the UK. Three bi-national S&T Centers operate under intergovernmental agreements with France, Germany, and the USA. The Indo-French Centre for Promotion of Advanced Research (IFCPAR/CEFIPRA) facilitates integrative collaborations across Indian science ministries, and the Indo-German Science & Technology Centre (IGSTC) focuses on advanced industrial research partnerships and developing joint knowledge pools to address global challenges. India is engaging in numerous bilateral agreements to promote biomedical research, with partnerships including the Indian Council of Medical Research (ICMR).    No Turning Back India has signed many agreements with countries of the European Union on a bilateral basis and in  consortium. India has been working on a Trade and Economic Partnership Agreement (TEPA) with European Free Trade Association (EFTA) countries comprising Switzerland, Iceland, Norway & Liechtenstein. India- EFTA signed a TEPA in March last year. TEPA will give impetus to “Make in India” and Atmanirbhar Bharat by encouraging domestic manufacturing in the pharmaceutical sectors, among others. Complementing the above scenario, it is worth mentioning that India's advantages, including cost-effective manufacturing, a skilled workforce, and a growing but robust research ecosystem, are making it an attractive destination for outsourcing and joint ventures. These collaborations have led to the development of innovative healthcare solutions and have expanded market access for both Indian and European firms. The collaboration between India and Europe in the life sciences sector has emerged as a cornerstone for global healthcare innovation, offering significant advancements in therapeutics, vaccines, and biologics. Over recent years, this partnership has expanded across academic research, contract research and manufacturing, and healthcare resilience efforts, fostering mutual growth and international progress. India and Europe have established robust collaborations in the life sciences sector through academic research partnerships as well. These collaborations encompass joint research initiatives, funding schemes, and institutional partnerships aimed at advancing scientific knowledge and addressing global health challenges. The India-Europe collaboration in life sciences has evolved into a dynamic partnership fostering innovation, investment, and shared expertise. While significant strides have been made in contract research, vaccine production, and biosimilars, there remains potential for greater collaboration in new drug discovery sciences. As European companies expand their R&D and manufacturing presence in India, the mutual focus on academic research and healthcare resilience positions this partnership as a global leader in life sciences innovation.    Shivani Thakar shivani.thakar@biospectrumindia.com  ]]> https://biospectrumindia.com/news/97/25542/aragen-secures-100-m-investment-from-quadria-capital-.html https://biospectrumindia.com/news/97/25542/aragen-secures-100-m-investment-from-quadria-capital-.html Mon, 13 Jan 2025 00:00:00 +0530 Aragen, a globally renowned Contract Research, Development and Manufacturing Organisation (CRDMO), has secured a $100 million investment from Quadria Capital, an Asia healthcare-focused Private Equity fund. The investment will result in Quadria acquiring a minority stake in Aragen, at an approximate valuation of $1.4 billion, primarily through a fresh capital infusion, with a small portion from the sale of shares by existing investors. This funding will support Aragen’s strategic expansion of its capabilities and infrastructure, enabling the company to meet the growing demand for outsourcing services from innovators in the US and Europe With this investment, Quadria joins Goldman Sachs as the second strategic investor in Aragen. This partnership further solidifies Aragen's reputation for delivering high-quality “concept to clinic” and “concept to commercial” services to its global customer base comprising all sectors of health – Human, Animal and Plant. The announcement comes ahead of JPM Week 2025, where Aragen is expected to secure additional outsourcing partnerships. Manni Kantipudi, CEO, Aragen Life Science said, “Our expanded capabilities will allow us to support the rising demand for integrated discovery and manufacturing services, and, most importantly, help our customers accelerate their programs to market faster and more efficiently.” ]]> https://biospectrumindia.com/news/97/25508/akums-opens-new-facility-for-lyophilised-and-sterile-dosage-manufacturing.html https://biospectrumindia.com/news/97/25508/akums-opens-new-facility-for-lyophilised-and-sterile-dosage-manufacturing.html Sat, 04 Jan 2025 00:00:00 +0530 Akums Drugs & Pharmaceuticals, a Delhi-based Contract development and manufacturing organization (CDMO), has announced its new state-of-the-art sterile manufacturing facility, dedicated to producing lyophilised products, in Haridwar. In addition to lyophilised injectables, the facility is equipped to manufacture vials, ampoules, Form-Fill-Seal (FFS) products, and eye and ear drops. The global lyophilised injectables market, estimated at a value of approximately $3,365.4 million in 2023, is expected to experience steady growth, reaching an impressive $4,978.3 million by 2030. With a compound annual growth rate (CAGR) of 5.6% during the forecast period, this market demonstrates strong potential driven by increasing demand for products requiring enhanced stability and extended shelf life. As a niche segment with high entry barriers and limited competition, it presents significant opportunities to innovate and cater to specialized therapeutic needs. This growth highlights the strategic importance of investing in lyophilization capabilities. The facility, which is now operational, is equipped with state-of-the-art technology to produce high-quality lyophilised (freeze-dried) products across various therapeutic categories. Lyophilisation is a crucial process in preserving the stability and shelf life of pharmaceutical products, especially for sensitive chemical compounds. By entering this space, Akums aims to meet the growing global demand for these products. Akums' lyophilisation facility offers a robust production capacity and the flexibility to handle multiple vial sizes, ensuring it can cater to a broad range of healthcare needs.      ]]> https://biospectrumindia.com/news/97/25509/veeda-group-rebrands-as-veeda-lifesciences.html https://biospectrumindia.com/news/97/25509/veeda-group-rebrands-as-veeda-lifesciences.html Fri, 03 Jan 2025 00:00:00 +0530 Veeda Group has unveiled a new logo and brand identity- Veeda Lifesciences- marking a key milestone in its journey. The new brand name reflects the evolution from a generics-focused Contract Research Organization (CRO) to a drug development services enterprise for different modalities of drugs including generics and novel chemical and biological entities. Veeda Lifesciences will operate through four Strategic Business Units: Clinical Trials, Healthy Volunteer Services, Biopharma Services, and Preclinical & Non-Clinical Testing Services, making Veeda an integrated research service provider. Veeda Lifesciences represents the brand that integrates Veeda Clinical Research, Health Data Specialists, and Bioneeds India, showcasing its research services across various stages of the drug development value chain from discovery and preclinical to late-phase development. This new identity reflects the transition from generics to innovation, local to global, and small molecules to biologics, transitioning to a CRO-CDMO model, while leveraging AI & Real-world data. Founded in India in 2004, Veeda Lifesciences now operates out of 5 countries while conducting trials in 26 geographies. The strategic acquisition of Bioneeds in 2021 expanded Veeda into preclinical services.  ]]> https://biospectrumindia.com/news/97/25339/us-based-shearwater-health-opens-new-opportunities-for-indias-clinical-talent-with-expansion-in-chennai.html https://biospectrumindia.com/news/97/25339/us-based-shearwater-health-opens-new-opportunities-for-indias-clinical-talent-with-expansion-in-chennai.html Mon, 11 Nov 2024 00:00:00 +0530 Shearwater Health, a leader in clinician-led clinical solutions for healthcare partners, has announced its expansion into India with the opening of a new office in Chennai, a key hub for healthcare and technology expertise. This Chennai-based expansion is anticipated to create 1,000 jobs for local clinicians by the end of 2025, who will deliver high-quality remote clinical services to Shearwater’s US healthcare clients. As part of its global offerings, Shearwater offers clinical experts following Six Sigma processes to drive exceptional outcomes for its clients’ patients. “Our expansion into India allows us to broaden our service offerings with a wide range of skillsets across multiple countries,” said Giri Namala, Chief Growth Officer of Shearwater Health. “By establishing a diverse talent pool in key markets, we can offer our clients greater flexibility and choice in meeting their unique needs. India’s skilled professionals complement our capabilities in the Philippines and the US, enabling us to provide comprehensive solutions that drive impactful outcomes.” In addition to Shearwater Health’s new offerings for healthcare providers in India, its global team of highly skilled clinical experts will recruit and train new talent within the region, creating new jobs in the market as well as international opportunities for nurses who are interested in working in the US. Factors that impacted the company’s decision to expand into Chennai included top-tier talent and the growing business and healthcare community across the region, according to a report from KPMG. ]]> https://biospectrumindia.com/features/97/25309/can-india-leverage-us-biosecure-act-to-strengthen-crdmos.html https://biospectrumindia.com/features/97/25309/can-india-leverage-us-biosecure-act-to-strengthen-crdmos.html Thu, 31 Oct 2024 00:00:00 +0530 With China as a leading destination for the USA for outsourcing contract manufacturing and research services in the biotech and pharmaceutical sectors, this Act can affect supply chain dynamics in these sectors and countries like India are positioned to be alternative destinations for the US for Contract Development and Manufacturing Organisations (CDMO)/ Contract Research Organisations (CRO) services and capitalise on this. Let's take a look at what its implications would be on the Indian CRDMO sector. The US Biosecure Act aims to decouple its supply chains from China, presenting a huge opportunity for India’s pharma industry. Experts predict that the US Biosecure Act is set to make a strong impact on the entire pharma and biotech sectors globally. The Act restricts US pharmaceutical and biotech companies from outsourcing their services to China-origin Contract Research Development and Manufacturing Organisations (CRDMOs). The Act aims to encourage US pharmaceutical companies to diversify their supply chains, and to shift their partnerships from China to neighbouring countries like India. This move will further boost the already global approach of the China + 1 strategy and help grow India-based CRDMOs who can offer competitive cost advantages along with a skilled labour force for the global pharmaceutical markets. With new developments happening around the US Biosecure Act, India with its strengths in CRDMOs space has been in the driver seat and can look up to capitalise on the opportunities that this Act will open up in the coming period.    The Biosecure Act, which mandates a phased reduction of dependency on China by 2032, underscores the need for global pharma companies to recalibrate their global supply chain strategies. “Over the past few quarters, we have seen a steady shift, presenting significant opportunities for Indian CRDMOs to leverage the evolving pharma ecosystem and the large skilled workforce to attract global pharma companies,”  said Sibaji Biswas, Chief Financial Officer and Executive Director, Syngene International Ltd.    What India brings to the table The Indian pharmaceutical sector, particularly the CDMO/CROs is experiencing a significant transformation driven by strategic investments and evolving market trends. According to a recent industry report by Mordor Intelligence, the pharmaceutical CDMO Market revenue in India was valued at $15.63 billion in 2023, and is expected to reach $26.73 billion by 2028, growing at a CAGR of 11.34 per cent during the forecast period of 2023-28. The report also highlights that the market is witnessing growth in clinical trials, driving the demand. For instance, according to ClinicalTrials.gov, the total number of registered clinical studies was 437.513 million in 2022, reaching 477.237 million in 2023.  Looking at the increase in novel biomolecules and biopharmaceuticals taking up a niche in India’s burgeoning pharma market, the services sector, through advanced technology and specialised expertise, could be the highlight of the biopharma industry in the coming years. Owing to opportunities stemming from various novel biomolecules and biopharmaceuticals meeting with their patent expirations, multiple industry experts have estimated a significant growth of the Indian services market by the CDMO/CRO companies leveraging these.  Over the years, Indian CDMOs have invested in building state-of-the-art infrastructure. Reports and industry analysts are seeing the sector moving towards embracing advanced technologies, such as continuous manufacturing, and biomanufacturing capabilities, and also a focus on high-potency active pharmaceutical ingredients (HPAPIs) for instance. Experts state that India’s ability to offer high-quality services at a lower cost compared to Western countries remains one of its biggest advantages. This cost-effective proposition has the potential to further attract more multinational pharmaceutical companies looking to outsource their R&D and manufacturing needs.  Even in terms of skilled workforce and expertise, India is host to strong scientific capabilities in terms of academia, and Indian CROs and CDMOs have also developed certain expertise in areas like analytical services, process development, etc. In addition, favourable government policies to support the pharmaceutical sector through initiatives like "Make in India" and Production-Linked Incentives (PLI) schemes for the biopharmaceutical sector further strengthen the competitive position of Indian CDMOs/CROs in the global market. The introduction of new forward-looking policies like the BioE3 policy for biomanufacturing, which aims to pave the way for India to become a leading global biomanufacturing hub, would potentially be another feather in the cap of India’s able CDMO/CRO sector.  Expressing his thoughts on India's strengths Sanjay Vyas, President and Managing Director, Parexel India said, “Strategically, Indian CROs possess several advantages, including cost-effectiveness, a skilled workforce, and existing infrastructure capable of supporting increased production and research activities. Therefore, analysts predict that this shift will lead to a notable increase in demand for Indian CROs and CDMOs, which are well-positioned to fill the gap left by Chinese suppliers. This will simulate increased business opportunities for India, which in turn will project a doubling in market growth  in the next three years.”  In the context of India positioning itself as an able competing market for the Chinese market, Sibaji Biswas said "India is becoming the preferred choice in the supply chain realignment due to its robust talent pool, infrastructure, and comprehensive capabilities. As clients seek to diversify and mitigate risks in their supply chains, the move towards India is further driven by the solutions and capabilities we offer. This is significant not only for our company but also reflects a wider industry movement. The "China plus one" strategy has been in discussion for some time and with the development around the Biosecure Act we are now seeing action on the ground and a definitive momentum to diversify away from China. Syngene is strategically poised to take advantage of this trend. We are experiencing a surge in activity, client engagement, and numerous pilot projects”. Sharing his thoughts Dr Mahesh Bhalgat, Group CEO and Managing Director of Veeda Clinical Research Limited said “India offers advantages coming from strong scientific capabilities with graduates from world-renowned institutions IITs and IISc, NIPER including others. Government interventions through incentives schemes such as Promotion of Research and Innovation in Pharma-MedTech sector (PRIPs) and PLI, help in building more capacity and skillsets.”    Implications of the US Biosecure Act   The Biosecure Act, indeed, has the potential to transform India’s CDMO sector. By fostering a more robust regulatory and operational framework, it can attract substantial investment in infrastructure and talent. This, in turn, positions India to manage a growing influx of global collaborations and; partnerships and enhance its standing in the global pharmaceutical industry.  Welcoming the move, Dr Satinder Singh, Associate Director DMPK, Aragen Life Sciences, India opined, “The USA Biosecure Act is expected to further boost the growth of the Indian pharmaceutical and biotechnology manufacturing sector. Additionally, this Act which prohibits US origin firms to source the services or equipment from prominent Chinese CDMOs and CROs like Complete Genomics, WuXi AppTec, or WuXi Biologics may fuel the growth and expansion of Indian preclinical CROs.” Sharing his thoughts on the US Biosecure Act, Dr Bhalgat said “The US Biosecure Act is likely to have a cascading impact in two directions. First, other countries would look to reduce dependency on the Chinese supply chain and second, is the reduction in Chinese sourcing of raw materials and manufacturing components. As we are seeing, the transition is easiest to be done for developmental programmes, such as those in phase II and phase III clinical trials, as the starting point for moving activities out of China. The other area of opportunity that we see is in preclinical research. Currently, there is a significant amount of preclinical research conducted in the Chinese CRO space and revaluating these programmes is an expected outcome. Notable increase in opportunities, particularly for products in phases II and III, driven by the passage of the US Biosecure Act has also been observed in recent times during our dialogues with clients. With strategic planning and execution, India will be able to capitalise on this opportunity and become a major player in the global pharmaceutical landscape.”  “With the passage of this Act, more CROs in India will need to elevate their service offerings to meet the regulatory and quality expectations of US clients. To achieve this, they will likely invest in cutting-edge technologies and processes to enhance efficiency and ensure compliance with international standards. Consequently, the Act is expected to drive a significant increase in R&D investments among Indian CROs. There is also an anticipated increase in focus on biologics, biosimilars, Active Pharmaceutical Ingredients (APIs) and specialty drugs, areas where Indian firms can leverage their existing expertise. The demand for clinical trials in India is set to rise as US firms seek its diverse patient base and cost-effective services, leading to more trials by Indian CROs. Increased regulatory complexities will also boost the need for consulting services, giving Indian CROs with expertise a significant advantage,” said Sanjay Vyas.  Echoing similar views, Chandrachur Datta, Senior Partner with Vector Consulting Group said, “Manufacturing expansion in biosimilars is both time- and investment-intensive. Once the decision is made to expand capacities, the actual augmentation may take anywhere from 2 to 3 years, depending on the availability of supplies, equipment, and process validation capacities. This situation creates a challenge in determining the lead indicator: whether to capture market share first or to augment capacities first. Regardless, any company making expansion decisions should prioritise adopting the latest technology in this constantly evolving space. Following the enactment of the Biosecure Act, regulatory standards for biosimilars are anticipated to tighten as existing supply chains are disrupted and new ones emerge. To effectively navigate these changes and instil confidence in regulatory bodies, companies must equip themselves with advanced technologies and streamlined processes that ensure operational transparency and uphold quality standards.” He further added, “When pursuing long-term growth through expansion, companies often concentrate solely on acquiring manufacturing equipment, overlooking essential areas like raw material storage, quality control (QC), and quality assurance (QA) capacities. If these aspects are not scaled alongside manufacturing capacity, they may create bottlenecks that restrict overall capacity increases and diminish the effectiveness of the investment.”   Challenges  As the USA will aim to reorganise supply chains for pharma/biopharma outsourcing services, experts predict that shifting productions to other countries will involve challenges like high costs and higher capacities that will need to be built. According to a recent report, around 120 US biopharmaceutical drugs are currently being developed in partnership with Chinese CDMOs. Implications of the US Biosecure Act could mean extended development cycles and higher drug prices in the short term. Despite these challenges, analysts and industry experts predict that it could open up opportunities for Indian CDMOs that could offer competitive cost advantages along with a skilled labour force for the global pharmaceutical markets. Analysts suggest that increased focus of Indian CRDMOs on compliance and regulatory frameworks, to optimise safety and efficacy of their products according to global standards, effective strategic planning along with investing in infrastructure comprising advanced technologies, expansion of facilities with specialised capabilities etc. could position India as a leading destination for US biotech companies in the coming years. Talking about the strategies that will need to be implemented by Indian companies to stay globally competitive in this evolving landscape, Chandrachur Datta said, “To make significant leaps in the biosimilar space, the most important factor is technical know-how. For existing CDMOs that already possess a decent level of technical expertise for these molecules and have USFDA-approved facilities, scaling up is relatively straightforward. In contrast, CROs face significantly higher challenges related to technical know-how and clinical trials as they take on more projects. Improved technical expertise will enable firms to gain the confidence of innovators and regulatory authorities. For the long-term sustainability of this business, Indian CROs and CDMOs must prioritise investment in research and development. This commitment will enhance their expertise in biosimilar development and foster innovation, enabling them to create cutting-edge solutions. Additionally, forming strategic partnerships—an approach some companies have already adopted—with global biotech firms can provide access to advanced technologies, market insights, and collaborative research opportunities.” He further said that this implementation must go hand in hand with establishing robust quality assurance processes and strict adherence to Good Manufacturing Practices (GMP), as these are essential factors for building trust with both innovators and regulatory authorities, to ultimately position Indian companies as reliable players in the global biosimilars market. Raising concern about India's established supply chain relationships with Chinese API manufacturers,  Chandrachur Datta said, “As the new Act prevents involvement with the banned companies from China, even in the supply chain, steps must be taken immediately including Existing contracts should be evaluated and potentially terminated based on the likelihood of the firms being designated as “of concern.” The associated risk of losing business is significantly higher than the risk of premature contract termination. As soon as possible, substitutes for the equipment or services provided by these companies should be explored to avoid disruptions in business.” “To fully seize this opportunity, India must prioritise effective strategic planning and execution. This involves not only investing in physical infrastructure but also developing a robust regulatory framework, nurturing a skilled workforce, and fostering an environment that promotes innovation and quality. India needs to improve to be competitive to Chinese output i.e. speed and efficiency of delivery. Indian CROs and CDMOs need to partner with US counterparts to bring in efficiency and delivery of output. Indian firms do have other hurdles to clear like having advanced technology compared to their Chinese counterparts. Although the initial response has sparked greater investor interest in the US, it’s important not to underestimate the resilience and adaptability of the Chinese biotech sector, ” concludes Dr Mahesh Bhalgat.    Shivani Thakar  shivani.thakar@biospectrumindia.com    ]]> https://biospectrumindia.com/news/97/25279/global-crdmo-work-distribution-in-india-to-rise-up-to-10-by-2033-report.html https://biospectrumindia.com/news/97/25279/global-crdmo-work-distribution-in-india-to-rise-up-to-10-by-2033-report.html Fri, 18 Oct 2024 00:00:00 +0530 The global CRDMO (Contract Research Development & Manufacturing Organisation) industry is about to witness a re-distribution of outsourcing work across several Asian countries, with India and Korea emerging as new powerhouses by 2033. At the recent Scale-Up Health event by Eight Roads Ventures, McKinsey & Company presented survey findings that showed that global pharmaceutical companies are increasingly considering India as a destination for their outsourcing needs. As per McKinsey analysis, by 2033, India could potentially account for 8%-10% share of work outsourced to CDMOs globally, an outcome of the recent trend of significant amount of outsourced work shifting from EU/US to Asia. This growth is largely driven by the evolving geopolitical environment with most Indian CRDMOs expecting 20-40% of their new business to stem from these changes. Dr Prem Pavoor, Senior Partner, Head of India & India Healthcare Investments at Eight Roads Ventures, said "The evolving geopolitical landscape and impending legislation presents a significant opportunity for the Indian CDMO industry, one that could be truly transformative. We’re already seeing leading Indian biopharmaceutical companies receive more request-for-proposals, especially from US customers. Though these customers maybe adopting a wait-and-watch approach for now, it’s clear that, amidst global uncertainties, they will seek to diversify their outsourcing footprint. This creates a huge opportunity for India, but also a challenge because Indian CDMOs will need to be prepared with the right infrastructure and services to meet this increased demand." Sharing insights from the survey, Anirudh Roy Popli, Partner, McKinsey & Company, said, "The biopharma industry is increasingly recognising the value Indian CDMOs bring to the table. We are seeing increased interest levels across customer segments. However, building trust and long-term, at-scale partnerships takes time. With a strong focus on value and innovation, Indian CDMOs are well-positioned to play a pivotal role in shaping the future of healthcare.” ]]> https://biospectrumindia.com/news/97/25269/cdmo-onesource-receives-equity-commitments-of-rs-801-cr-from-marquee-investors.html https://biospectrumindia.com/news/97/25269/cdmo-onesource-receives-equity-commitments-of-rs-801-cr-from-marquee-investors.html Wed, 16 Oct 2024 00:00:00 +0530 Strides Pharma Science has announced that its associate company, OneSource Specialty Pharma (formerly known as Stelis Biopharma), Group’s Specialty Pharma CDMO (contract development and manufacturing organisation), has received confirmed commitments for fundraising of Rs 8010 crore (~$95 million) from marquee domestic and foreign institutional investors and family offices, in the pre-listing round. The share subscription agreements are being executed at a pre-money equity value of $1.65 billion, delivering to Strides’ shareholders an embedded value of Rs 663 per share of Strides’ holding in OneSource representing an ~82% premium over the previous embedded value of Rs 364 per share as per the Scheme of Arrangement announced earlier in September 2023. The strong interest from leading investors reflects growing confidence in our capabilities and the immense potential of the CDMO sector emerging out of India. This fundraise is in line with the Scheme of Arrangement announced in September 2023 and the investment is subject to customary closing conditions, including receipt of necessary regulatory approvals. DSK Legal acted as the legal counsel for OneSource and Transaction Square was the advisor to the Scheme.   On 25th September 2023, Strides announced the creation of OneSource, India’s first specialty pharma pure-play CDMO player by integrating Stelis’ Biologics CDMO, SteriScience's Complex Injectables, and Strides' Soft Gelatine businesses in a single entity by way of Scheme of Arrangement.   ]]> https://biospectrumindia.com/news/97/25243/multimodal-global-specialty-pharma-cdmo-onesource-launches-at-cphi-milan.html https://biospectrumindia.com/news/97/25243/multimodal-global-specialty-pharma-cdmo-onesource-launches-at-cphi-milan.html Wed, 09 Oct 2024 00:00:00 +0530 OneSource Specialty Pharma, a newly incorporated contract development and manufacturing organisation (CDMO), formed from the merger of three CDMO businesses within the Strides Group launches at CPHI Milan.   OneSource is strategically positioned, with the remarkable growth of GLP-1s and the BIOSECURE Act, to address the increasing demand for drug-device combinations and biologics drug substances and product.   The newly combined CDMO has five world-class facilities approved by major regulatory agencies, including the US FDA, EU, and TGA, with a workforce of over 1,200 professionals.   OneSource has capabilities spanning supply-constrained drug-device combinations, biologics, and soft gelatin capsules – with the capacity to produce more than 100 million injectable doses including cartridges and pre-filled-syringes and 2.4 billion soft gelatin capsules. Notably, its flagship site in Bengaluru is one of the few globally capable of manufacturing both biologics drug substance and drug product on the same premises.   The company’s end-to-end offering across all its platforms was established in response to its customers’ need to streamline supply chains by consolidating their outsourcing partners. The three combined businesses, each serve over 50 global clients, and together reduce complexity, cost, and resources associated with managing multiple CDMO service providers.   OneSource is projected to achieve a remarkable 32% revenue growth in 2025, with sales anticipated to reach $400 million by 2028.  ]]> https://biospectrumindia.com/news/97/25248/jubilant-biosys-to-add-drug-discovery-preclinical-development-capabilities-in-biologics-and-adc.html https://biospectrumindia.com/news/97/25248/jubilant-biosys-to-add-drug-discovery-preclinical-development-capabilities-in-biologics-and-adc.html Wed, 09 Oct 2024 00:00:00 +0530 Jubilant Biosys Innovative Research Services Limited (JBIRSPL), a subsidiary of Jubilant Biosys Limited (the business operates from Bengaluru, Noida and Greater Noida), a wholly owned subsidiary of Jubilant Pharmova Limited and Pierre Fabre SA are entering in a strategic partnership. Pursuant to this, JBIRSPL would acquire 80% equity capital in Jasmin (new company incorporated in France, as a Société par Actions Simplifiée (SAS), 100% owned by Pierre Fabre). Jasmin shall acquire Pierre Fabre’s R&D Centre (Including R&D Site and R&D activities) at Saint Julien, France upon closing of the transaction.  This strategic partnership will enable Jubilant Biosys Limited to expand its footprint in Europe in areas like Biologics (mAbs) and Antibody Drug Conjugate (ADC), in addition to its existing services including integrated drug discovery services from India. Speaking on the announcement, Giuliano Perfetti, CEO & Managing Director of Jubilant Biosys Limited said, "The facility in Saint Julien will serve as our European Centre of Excellence for Biologics and ADCs, located in the heart of Europe. This will enhance our footprint and collaboration with both biotech and large pharma companies in Europe and the US. By combining the scientific expertise in Biologics and ADCs at our Saint Julien site with the capabilities of 1,200 scientists at our Centres of Excellence for Drug Discovery, Chemistry and CDMO in India, we can develop a unique delivery model tailored to our customers' needs, driving our company’s growth. With this strategic move, Jubilant Biosys continues to strengthen its position as a preferred “CRDMO Partner in Science,” committed to delivering innovative solutions to our customers.”  ]]> https://biospectrumindia.com/news/97/25234/enzene-unveils-next-generation-of-fully-connected-continuous-manufacturing-technology-for-biologics.html https://biospectrumindia.com/news/97/25234/enzene-unveils-next-generation-of-fully-connected-continuous-manufacturing-technology-for-biologics.html Sat, 05 Oct 2024 00:00:00 +0530 Enzene, a fully integrated contract development and manufacturing organisation (CDMO) with services spanning discovery, development and commercial supply, is launching its new EnzeneX 2.0 technology at the CPHI Milan show in Italy, being held from October 8 – 10, 2024.   The patented technology is a further evolution of the company’s fully-connected continuous manufacturing (FCCM) platform for commercial biologics supply.   The EnzeneX 2.0 platform provides uninterrupted processing, from perfusion to final drug substance. By employing high titer clones, productivity and target protein concentrations are improved, production can be streamlined, and risks associated with batch-to-batch transfers are mitigated.   Additionally, EnzeneX 2.0 will leverage optimised cell media to boost cell productivity and efficiency, while also incorporating process analytical technology (PAT) to enable real-time monitoring and control for consistent quality and optimized processing.   Himanshu Gadgil, CEO of Enzene said “Lower operational costs and higher productivity can enable up to 50% reductions in overall production cost per gram, and we are on target to achieve a game-changing benchmark by 2025. We expect that our FCCM will be able to deliver 40 kilograms per thousand-liter batch at $40-per-gram.”   First developed at Enzene’s facility in Pune, the EnzeneX 2.0 platform reduces the equipment footprint compared with conventional fed-batch systems. It is capable of clinical phase cGMP supply from as low as 30-liter scale, and its modular design with variable bioreactor capacity accommodates scale-on and scale-out expansion. Enzene’s launch of a new state-of-the-art $50-million manufacturing facility in Hopewell, New Jersey, ensures new opportunities for the biotech industry as the company introduces fully-connected continuous manufacturing in the US. The facility is expected to be fully operational by Q1 2025.   ]]> https://biospectrumindia.com/news/97/25217/piramal-pharma-solutions-announces-80-m-expansion-plan-for-sterile-injectables-facility-in-kentucky-us.html https://biospectrumindia.com/news/97/25217/piramal-pharma-solutions-announces-80-m-expansion-plan-for-sterile-injectables-facility-in-kentucky-us.html Mon, 30 Sep 2024 00:00:00 +0530 Mumbai-based Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., has unveiled an $80 million investment plan to expand its Lexington, Kentucky facility in the US. The site specialises in sterile compounding, liquid filling, and lyophilisation for sterile injectable drug products, playing a vital role in Piramal Pharma Solutions integrated antibody-drug conjugate development and manufacturing program, ADCelerate. The investment, financed by bank loans and internal accruals, aims to enhance the site's existing capacity and capabilities to meet the demands of a rapidly growing market. With this expansion, Piramal Pharma will strengthen its position as an efficient and reliable global partner for biologic manufacturing, leveraging deep scientific expertise and extensive experience managing complex technical projects. The expansion will equip the Lexington site with an additional 24,000 square feet of manufacturing space, a new laboratory, and state-of-the-art machinery to scale clients' products effectively. Key additions include a new filling line, two commercial-size lyophilisers, a special capping machine, and an external vial washer. Currently, the Lexington site can manufacture 104 product batches per year (utilisation at peak levels). Upon completion of the expansion in Q1 of 2027, this capacity will increase to over 240 annual batches. The expansion will create over 40 full-time jobs, contributing to the area's economic development and fostering a diverse, vibrant workforce. ]]> https://biospectrumindia.com/news/97/25142/akums-secures-patent-for-new-formulation-aimed-at-managing-sickle-cell-disease.html https://biospectrumindia.com/news/97/25142/akums-secures-patent-for-new-formulation-aimed-at-managing-sickle-cell-disease.html Fri, 13 Sep 2024 00:00:00 +0530 Akums Drugs and Pharmaceuticals, New Delhi-based Contract Development and Manufacturing Organisation (CDMO), has been awarded a patent for its Room Temperature Stable Oral Suspension of Hydroxyurea, a breakthrough formulation aimed at managing Sickle Cell Disease (SCD). This development reinforces Akums' role as an innovator in pharmaceutical solutions, offering a significant advance in addressing the storage and accessibility challenges associated with Hydroxyurea solution. Sickle Cell Disease, a genetic blood disorder, leads to severe health complications such as anaemia, frequent pain episodes and other debilitating symptoms, affecting millions worldwide especially in India and Africa. Akums' new formulation offers a key advantage over traditional Hydroxyurea solution that require refrigeration between 2–8°C. Akums' breakthrough aligns with India's National Sickle Cell Anemia Mission, spearheaded by Prime Minister Narendra Modi, which aims to enhance the quality of life for SCD patients by improving treatment options. In comparison to Hydroxy Urea Capsule (500mg), Akums Hydroxy Urea suspension offers dose flexibility based on body weight of the SCD patients, thus offering significant advantage for paediatric and adolescent patients.  The patented formulation will now come at a fraction of the cost of imported Hydroxyurea solution. With this new patent, Akums continues to advance healthcare through innovation, ensuring life-saving treatments reach those who need them the most. ]]> https://biospectrumindia.com/news/97/25096/enzene-appoints-norm-stoffregen-to-lead-biologics-manufacturing-facility-in-us.html https://biospectrumindia.com/news/97/25096/enzene-appoints-norm-stoffregen-to-lead-biologics-manufacturing-facility-in-us.html Tue, 03 Sep 2024 00:00:00 +0530 Enzene Biosciences, a fully integrated contract development and manufacturing organisation (CDMO) with services spanning discovery, development and commercial supply, has announced the appointment of Norm Stoffregen as SVP, site head, and head of biologics manufacturing at the company’s new $50 million manufacturing facility in Hopewell, near Princeton, New Jersey, US.   As well as taking responsibility for Enzene’s global biologics business, Stoffregen will lead the final stages of work to commission the 54,000-square-foot facility. He will then lead ongoing operations at the site, where the company intends to transfer-in existing customers’ manufacturing projects and expand to add further bioreactor capacity, employing a workforce of 300 by the end of 2025.   Significantly, Stoffregen brings a vast experience of building manufacturing businesses, having worked in the area since 2015 when the Hopewell facility was owned by Bristol Myers Squibb (BMS).   Immediately prior to joining Enzene, Stoffregen was VP-site head at PTC Therapeutics, and before that held various roles of increasing responsibility at BMS and with other biotherapeutics/bioprocessing companies, where he amassed more than 20-years’ experience in leadership, quality assurance, and Chemistry, Manufacturing and Controls (CMC). ]]> https://biospectrumindia.com/news/97/25034/vipragen-biosciences-and-zumutor-biologics-form-strategic-alliance-in-biologics-cro-sector.html https://biospectrumindia.com/news/97/25034/vipragen-biosciences-and-zumutor-biologics-form-strategic-alliance-in-biologics-cro-sector.html Wed, 14 Aug 2024 00:00:00 +0530 Bengaluru-based companies Vipragen and Zumutor have announced a strategic partnership to set up an end-to-end Biologics contract research organisation (CRO) platform to support discovery, clone to pre-clinical development of biologics/biosimilars. This partnership will address ‘all things biology’ from biologics discovery and development to Investigational New Drug Application (IND) submissions. This will address the needs of research programmes from institutions and emerging to mid-size biotech companies. These programmes focus on biologics for cancer biology, metabolic diseases, pain and inflammation, and neuroscience. Through this collaboration, Vipragen and Zumutor aim to expedite R&D progression, ensure high-quality data, and reduce costs by bringing global research programmes to progress into quicker commercialisation stage. This strategic alliance is expected to enhance the capabilities of both organisations and significantly contribute to the innovators to take their programmes to next level.  "We are confident that this strategic collaboration will enhance our capabilities and contribute significantly in advancing innovation in the biologics space. Our partnership promises to deliver end to end solutions and drive research excellence, benefiting clients and partners worldwide," said Dr Chandrasekaran, Chairman and MD of Vipragen. "This partnership with Vipragen marks a significant milestone for us. By combining our innovative antibody discovery platform with Vipragen's extensive pre-clinical capabilities, we aim to provide unmatched value to our clients and substantial value to both the Companies. Together, we will drive the next generation of biologics research for innovators," said Kavitha Iyer Rodrigues, Founder & CEO of Zumutor. ]]> https://biospectrumindia.com/news/97/25010/merck-life-science-india-inks-mou-with-aragen-to-focus-on-mab-manufacturing.html https://biospectrumindia.com/news/97/25010/merck-life-science-india-inks-mou-with-aragen-to-focus-on-mab-manufacturing.html Fri, 09 Aug 2024 00:00:00 +0530 Merck Life Science in India has signed a Memorandum of Understanding (MoU) with Aragen, a leading R&D and manufacturing solutions provider, in small molecules and biologics, to the global life sciences industries, a leader in drug discovery in Bengaluru. The MoU was signed by Aditya Sharma, Head of Process Solutions, India Region, Merck Life Science , and Subodh Deshmukh, CEO Aragen Bioscience. The collaboration between Aragen and Merck will facilitate the supply of equipment and technologies for mAb (monoclonal antibody) manufacturing and process development for novel modalities. This accelerates the clinical-to-commercial process timeline and enables customers to develop the right molecule and scale up with our support. The agreement underscores Merck’s extensive commitment to novel modalities and early engagement in R&D with emerging biotechnology startups in the country. ]]> https://biospectrumindia.com/news/97/24963/onesource-gets-access-to-bhamis-research-labs-tech-to-deliver-high-concentration-biologics-subcutaneously.html https://biospectrumindia.com/news/97/24963/onesource-gets-access-to-bhamis-research-labs-tech-to-deliver-high-concentration-biologics-subcutaneously.html Tue, 30 Jul 2024 00:00:00 +0530 Bengaluru-based OneSource Specialty Pharma (formerly known as Stelis Biopharma), associate company of Strides and India’s first specialty pharma pure-play Contract Development and Manufacturing Organisation (CDMO) has entered into a strategic licensing agreement with Bhami’s Research Laboratory (BRL). This partnership will provide OneSource with access to BRL’s HILOPROÒ formulation technology, enabling the subcutaneous delivery of high-concentration biologic therapies.  This innovative technology aims to reduce viscosity and facilitate the delivery of high-concentration biologic products, applicable across a broad spectrum of monoclonal antibodies and fusion proteins. Under the agreement, OneSource will offer BRL’s innovative formulation technology, enhancing its development and manufacturing services for both drug products and substances. OneSource offers world-class capabilities across biologics, complex injectables and drug-device combination products, soft gelatin capsules and has demonstrated experience on different therapeutic modalities and technology platforms. With five state-of-the-art cGMP facilities and a global customer base, OneSource has an impeccable quality compliance record with successful inspections by major health agencies, including the US FDA and EU authorities.   ]]> https://biospectrumindia.com/news/97/24931/agilent-buys-north-american-cdmo-biovectra-for-925-m-.html https://biospectrumindia.com/news/97/24931/agilent-buys-north-american-cdmo-biovectra-for-925-m-.html Mon, 22 Jul 2024 00:00:00 +0530 Agilent Technologies Inc. has signed a definitive agreement to acquire Biovectra, a leading specialised contract development and manufacturing organization (CDMO), for $925 million.  Based in Canada, Biovectra produces biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics. The acquisition builds on Agilent's CDMO specialisation in oligonucleotides and CRISPR therapeutics in three key areas- Expands portfolio of services; Adds rapidly growing modalities; and Brings world-class capabilities to support gene editing.  Biovectra supports early-stage clinical development to large-scale commercial manufacturing. The company currently serves biotech and pharmaceutical companies in North America and Europe. Biovectra delivered $113 million in revenue during 2023 and expects double-digit revenue growth in 2024. Agilent expects that the acquisition will be $0.05 dilutive to non-GAAP EPS in the first full year after closing. Agilent will fund the transaction using a mix of cash on hand and debt financing. The transaction is subject to customary closing conditions, including receipt of regulatory approvals, and is expected to close before 2025. Upon close, Biovectra will become part of the Agilent Diagnostics and Genomics Group.   ]]> https://biospectrumindia.com/news/97/24863/navin-molecular-to-invest-35-m-for-expanding-manufacturing-capabilities.html https://biospectrumindia.com/news/97/24863/navin-molecular-to-invest-35-m-for-expanding-manufacturing-capabilities.html Wed, 03 Jul 2024 00:00:00 +0530 Navin Molecular, a Madhya Pradesh-headquartered Contract Development and Manufacturing Organisation (CDMO), has announced a significant investment of Rs 288 crore (approximately $35 million) to expand its GMP manufacturing plant in Dewas. The new 9,000-square-meter facility will nearly double the site’s overall capacity to 420 cubic meters, supporting existing commercial-scale projects and meeting future demand as the company continues to grow its global customer base. The multi-purpose facility will add 200 cubic meters of manufacturing capacity, incorporating various vessel types including stainless steel, glass-lined, Hastelloy, and Inconel. It will handle a wide range of chemistries, including hazardous processes such as direct fluorination, cyanation, azide chemistry, cryogenic reactions, and high-pressure hydrogenation. The plant will feature a high level of automated control, including a distributed control system (DCS), enhancing efficiency and minimizing risks to employees and the environment. The expansion will also boost the size and capacity of the site's existing 21 CFR-compliant QC laboratory for in-process testing and final product release. A new process safety laboratory and a dedicated zero liquid discharge (ZLD) effluent treatment plant will be constructed. The facility will adhere to India’s optimum green building concepts, leveraging modern technologies in materials, equipment, and design, including renewable energy generation and solvent containment. A ground-breaking ceremony was held in April 2024, and the project is expected to be completed by the end of 2025, creating up to 100 new jobs. Navin Molecular, launched in 2023 as the CDMO division of Navin Fluorine, supports global pharmaceutical innovators. Its 47-acre state-of-the-art site in Dewas offers process research and development through to commercial manufacturing of a wide range of regulatory starting materials and API intermediates. ]]> https://biospectrumindia.com/news/97/24781/kemwell-biopharma-revopsis-partner-to-expedite-development-of-novel-multispecific-biologics.html https://biospectrumindia.com/news/97/24781/kemwell-biopharma-revopsis-partner-to-expedite-development-of-novel-multispecific-biologics.html Mon, 17 Jun 2024 00:00:00 +0530 RevOpsis Therapeutics, a US-based next-generation biopharmaceutical startup spearheading innovation of multispecific ophthalmic therapies, and Bengaluru-based Kemwell Biopharma, a leading biologics contract development and manufacturing organization (CDMO), have announced a broad strategic manufacturing partnership. This collaboration aims to accelerate the development of RevOpsis' lead candidate, RO-104, a first-in-class tri-specific biologic for the treatment of neovascular age-related macular degeneration (nAMD). Under this partnership, Kemwell will manufacture RO-104, a novel tri-specific biologic designed to target the three dominant angiogenic pathways (VEGF-A, VEGF-C, Ang-2) for treating nAMD, a leading cause of blindness worldwide. The unique ability of RO-104 to bind these three validated targets simultaneously positions it as a first-in-class fully human monotherapy biologic, poised to redefine the treatment landscape for retinal vascular diseases. As India's first commercial current Good Manufacturing Practices (cGMP) manufacturing facility, Kemwell is a trusted and respected partner with extensive experience in complex protein manufacturing. This collaboration leverages Kemwell's well-established manufacturing excellence and RevOpsis' innovative Rev-Mod platform to expedite the development of novel multispecific biologics. This new alliance provides RevOpsis a critical biologics development solution to rapidly transition from pre-clinical activities to first-in-human clinical trials, expediting the development of RO-104 and the broader platform. By integrating RevOpsis' next generation plug-and-play multispecific biologics platform with Kemwell's deep biologics development and manufacturing knowledge, the collaboration aims to accelerate therapeutic discovery to IND submission timelines. ]]> https://biospectrumindia.com/news/97/24768/suven-to-acquire-controlling-stake-in-oligonucleotide-focused-cdmo-player-sapala-organics.html https://biospectrumindia.com/news/97/24768/suven-to-acquire-controlling-stake-in-oligonucleotide-focused-cdmo-player-sapala-organics.html Thu, 13 Jun 2024 00:00:00 +0530 Suven Pharmaceuticals, one of India’s largest integrated contract development and manufacturing organisation (CDMO) players, has entered into a definitive agreement for a strategic controlling investment in Sapala Organics, subject to regulatory approvals and conditions. Sapala is a Hyderabad based CDMO focused on oligo drugs and nucleic acid building blocks including specialised/modified Amidites & Nucleosides, drug delivery compounds (including GalNAc), Pseudouridine, amongst others. Oligo & nucleic acid building blocks market is a ~$750 million market and is expected to grow at a robust ~20% CAGR. Sapala is one of the very few players globally with experience in a comprehensive range of specialised building blocks. Sapala has a strong customer base including innovator pharma, CDMOs & diagnostic companies, and is a key partner in their oligo drug new chemical entities (NCE) programmes. Suven is to acquire 67.5% equity stake (i.e. 51% of the share capital of Sapala Organics on a fully diluted basis) for a consideration of Rs 229.5 crore subject to customary working capital and net debt adjustments. The company will acquire the remaining equity stake a few months after FY2026-27, as per the terms of the definitive agreements. Upon consummation, the company will own 100% of the share capital of Sapala on a fully diluted basis. The transaction is subject to customary closing conditions. Steadmount Capital Advisors and Banyan Advisory acted as advisors to Sapala. Dr P Yella Reddy, founder of Sapala said “I look forward to working with the larger team at Suven for their Japan market initiatives and hope to contribute to the platform’s success in that market.” Sapala had a revenue of over Rs 670 millionn and adjusted EBITDA margins of 45%+ for FY24.   ]]> https://biospectrumindia.com/news/97/24725/syngene-launches-platform-for-rapid-enhanced-protein-production.html https://biospectrumindia.com/news/97/24725/syngene-launches-platform-for-rapid-enhanced-protein-production.html Wed, 05 Jun 2024 00:00:00 +0530 Bengaluru-based Syngene International, a leading global contract research, development and manufacturing organization (CRDMO), has announced the launch of its new protein production platform. The platform, using a cell line and transposon-based technology in-licensed from Swiss biotech services company, ExcellGene, coupled with Syngene's clone selection and development processes, promises significant improvement in efficiency and precision. The new platform accelerates enhanced protein production, enabling quicker preclinical and clinical development as well as product launches, thereby reducing time to market. The new platform streamlines clone selection and enhances operational productivity. It also supports a wide range of biomolecules including monoclonal antibodies, biosimilars, bispecifics, antibody-drug conjugates and other recombinant proteins. This versatility facilitates integration with both perfusion and fed-batch manufacturing processes. A track record in developing multiple monoclonal antibodies with the new technology underscores its effectiveness and reinforces Syngene's ability to provide innovative solutions for its clients. By combining this technology with Syngene's existing capabilities, the company now offers a full range of end-to-end cell line development options, using the latest technology to deliver tangible benefits to customers. "By combining the cell line and transposon-based platform from ExcellGene with our proprietary processes, we are pushing the boundaries in cell line development. This innovative approach will not only accelerate development timelines but also enhance the overall reliability and efficiency of the process, delivering substantial benefits to our clients," said Sridevi Khambhampaty, Vice President, Biopharmaceutical Development, Syngene International.  ]]> https://biospectrumindia.com/news/97/24714/aurigene-pharma-announces-opening-of-biologics-facility-in-genome-valley.html https://biospectrumindia.com/news/97/24714/aurigene-pharma-announces-opening-of-biologics-facility-in-genome-valley.html Mon, 03 Jun 2024 00:00:00 +0530 Aurigene Pharmaceutical Services, a Dr. Reddy’s Laboratories company, inaugurated its biologics facility spread across 70,000 sq.ft. in Genome Valley, a bio cluster, located in Hyderabad. The facility is designed to serve customers with process & analytical development and small scale manufacturing of antibodies and other recombinant proteins for preclinical and early phase clinical requirements. The process and analytical development laboratories are now operational while the commissioning of manufacturing capacity will be completed later in 2024. The state-of-the-art facility is equipped with best-in-class equipment and control systems, supported by an experienced talent pool that will ensure seamless transfer to large-scale commercial CGMP manufacturing facilities. The new facility is complementary to the company’s current discovery capabilities and infrastructure, which primarily focuses on recombinant proteins including mAbs, bi- and multi-specifics, immune-fusion molecules, antibody drug conjugates and other complex proteins. The newly opened Genome Valley facility will deliver robust, compliant and economically viable cell lines, process development solutions and supporting analytical methods in support of customers seeking to rapidly enter and progress through clinical development.  The opening of this latest facility is one of multiple strategic initiatives that Aurigene is implementing to support rapid growth in both the small molecule and biologics spaces, as illustrated by recent announcements related to AI/ML-led drug discovery in small molecules and a collaboration with Vipergen, a DNA-encoded library (DEL) technologies service provider.   ]]> https://biospectrumindia.com/news/97/24698/enzene-launches-new-discovery-services-division.html https://biospectrumindia.com/news/97/24698/enzene-launches-new-discovery-services-division.html Thu, 30 May 2024 00:00:00 +0530 Enzene Biosciences, Pune-based contract development and manufacturing organisation (CDMO) known for its flagship fully-connected continuous manufacturing platform (EnzeneX), has announced the launch of a new Drug Discovery Division. This further expands the CDMO's breadth of services to the biotech industry and complements its EnzeneX equipped biologics manufacturing site, which will open later this summer in the US. Enzene is introducing its new discovery arm to provide end-to-end integrated discovery services in response to the rapidly growing industry demands. The discovery offerings will include antibody services (target validation, discovery and engineering), reagent production ranging from custom peptides & proteins to advanced modalities like plasmids, RNA and exosomes, and multi-platforms assays services. While financial details remain undisclosed, the new Discovery Division will be located at Enzene’s Pune facility, with new state-of-the-art discovery laboratories set to be operational by July and further expansions planned later in the year. Enzene will open its $50 million New Jersey site this summer, which will also be the first site in the USA with a fully connected continuous manufacturing platform and will be staffed by over 300 personnel. The CDMO has immediately available capacity to produce complex proteins along with standard modalities via both CHO and mammalian cell lines. ]]> https://biospectrumindia.com/news/97/24699/enzene-launches-discovery-services-division-in-us.html https://biospectrumindia.com/news/97/24699/enzene-launches-discovery-services-division-in-us.html Thu, 30 May 2024 00:00:00 +0530 Enzene Biosciences, Pune-based contract development and manufacturing organisation (CDMO) known for its flagship fully-connected continuous manufacturing platform (EnzeneX) has announced the launch of a new Drug Discovery Division. This further expands the CDMO's breadth of services to the biotech industry and complements its EnzeneX equipped biologics manufacturing site, which will open later this summer in the US. Enzene is introducing its new discovery arm to provide end-to-end integrated discovery services in response to the rapidly growing industry demands. The discovery offerings will include antibody services (target validation, discovery and engineering), reagent production ranging from custom peptides & proteins to advanced modalities like plasmids, RNA and exosomes, and multi-platforms assays services. While financial details remain undisclosed, the new Discovery Division will be located at Enzene’s Pune facility, with new state-of-the-art discovery laboratories set to be operational by July and further expansions planned later in the year.   The news comes at an opportune moment for many US based innovators who are using BIO 2024 to diversify partners. This shift away from China is being accelerated by the ongoing Biosecure Act, with biotechs and pharma companies searching for new CRO discovery services and manufacturing partners for biologics (clinical and commercial). Enzene will open its $50 million New Jersey site this summer, which will also be the first site in the USA with a fully connected continuous manufacturing platform and will be staffed by over 300 personnel. The CDMO has immediately available capacity to produce complex proteins along with standard modalities via both CHO and mammalian cell lines. ]]> https://biospectrumindia.com/news/97/24610/qila-io-collaborates-with-mascot-spincontrol-to-bring-transparency-in-clinical-research.html https://biospectrumindia.com/news/97/24610/qila-io-collaborates-with-mascot-spincontrol-to-bring-transparency-in-clinical-research.html Fri, 10 May 2024 00:00:00 +0530 Mumbai-based Blockchain-As-A-Service company Qila.io has partnered with global clinical research centre Mascot Spincontrol to bring about transparency in clinical research through blockchain. The aim of the collaboration is to ensure that clinical trial data is secure, transparent and tamper-proof so that integrity of research outcomes is maintained. The partnership will enhance transparency in clinical research, fortify data security, and instil greater confidence among stakeholders. This will help result in positive regulatory outcomes and effective healthcare solutions. As part of this collaboration, Mascot Spincontrol and Qila.io have several joint projects and initiatives planned in the coming months. These include implementing blockchain tokenisation solutions for clinical research data sharing, pilot programmes to demonstrate the effectiveness of blockchain technology in improving data integrity and transparency, and exploring opportunities for further integration of blockchain solutions in healthcare research. These initiatives are aimed at delivering tangible results and demonstrating the value of our collaboration to the industry. Mumbai-based Mascot Spincontrolis a clinical research centre formed through a joint venture between Mascot Universal and Spincontrol France. In the future, the companies envision this partnership to evolve and to encompass a broader range of initiatives. These new initiatives will include the development of new blockchain-based solutions, the expansion of market presence, and the continued advancement of industry standards for data integrity and transparency. ]]> https://biospectrumindia.com/news/97/24577/maiva-pharma-secures-rs-1000-cr-investment-from-morgan-stanley-and-india-life-sciences-fund.html https://biospectrumindia.com/news/97/24577/maiva-pharma-secures-rs-1000-cr-investment-from-morgan-stanley-and-india-life-sciences-fund.html Thu, 02 May 2024 00:00:00 +0530 Maiva Pharma, a Bengalure-based Contract Development and Manufacturing Organisation (CDMO), has announced a significant milestone in its growth journey. The company has successfully raised approximately Rs 1,000 crore in primary and secondary funding from a fund managed by Morgan Stanley Private Equity Asia and India Life Sciences Fund - IV (ILSF - IV). This investment marks Maiva's first private equity fundraise and signals a significant move in the healthcare investment landscape. The funding has been utilised to acquire a controlling stake from existing investors and to infuse primary capital into the company. Maiva Pharma plans to allocate the proceeds towards the establishment of a new manufacturing facility near Hosur. This facility will boast capabilities in sterile dosage forms, including pre-filled syringes, bags, oncology, and hormonal injectables, thus expanding the company's production capacity and enhancing its product portfolio. Avendus, a leading financial advisory firm, facilitated the transaction as the exclusive financial advisor to Maiva and its shareholders. Dr Bhaskar Krishna, Managing Director and CEO, Maiva Pharma, said, "Over the last three years, Maiva has quadrupled its manufacturing capacity for US, Canada, and EU markets. Based on continued strong interest from customers in partnering with Maiva, we will expand at a greenfield site near Hosur. This fundraise will be used to add more vial, lyophilisation, and suspension capacity and introduce new manufacturing capabilities such as prefilled syringes, cartridges, and bags."   ]]> https://biospectrumindia.com/news/97/24461/aurigene-pharmaceutical-services-introduces-ai-and-machine-learning-assisted-drug-discovery-platform.html https://biospectrumindia.com/news/97/24461/aurigene-pharmaceutical-services-introduces-ai-and-machine-learning-assisted-drug-discovery-platform.html Wed, 03 Apr 2024 00:00:00 +0530 Aurigene Pharmaceutical Services, a contract research, development, and manufacturing services organisation and a Dr. Reddy’s Laboratories company, has introduced Aurigene.AI, an artificial intelligence (AI) and machine learning (ML)-assisted platform for accelerating drug discovery projects from hit identification to candidate nomination. Aurigene.AI combines advanced physics-based simulation, generative and predictive AI models, and CADD (Computer-Aided Drug Design) in one platform, allowing users to pick the appropriate algorithms for a given application. The modular platform also consists of a meticulously curated database of 180 million compounds and 1.6 million validated bioassay data points. This database is ever-expanding and serves as training data for the platform. Aurigene.AI is hosted on Google Cloud, which offers a scalable infrastructure for handling large datasets and efficient computation while safeguarding client data confidentiality. Integrating AI and ML-based solutions with Aurigene's core capabilities in chemical design, synthesis, and assessment in bioassays will facilitate faster development of novel therapeutics. Discovery scientists at Aurigene have validated the platform using a case study and demonstrated that the application of Aurigene.AI reduced the cycle time from chemical design to synthesis and testing by 35%.   ]]> https://biospectrumindia.com/news/97/24434/aragen-operationalises-first-phase-of-biologics-manufacturing-facility-in-bengaluru.html https://biospectrumindia.com/news/97/24434/aragen-operationalises-first-phase-of-biologics-manufacturing-facility-in-bengaluru.html Thu, 28 Mar 2024 00:00:00 +0530 Aragen, a leading Contract Research Development and Manufacturing Organization (CRDMO) for small molecules and biologics, has operationalised the first phase of its biologics manufacturing facility in Bengaluru, through its 100% subsidiary, Aragen Biologics. The facility is being set up at an investment of $30 million. It has also executed its first small-scale manufacturing project for a US-based organisation for manufacturing a novel anticancer monoclonal antibody (mAb). The non-GMP facility can undertake batch sizes upto 50 Ltrs and includes process development and analytical labs to support the manufacturing activities.  Manni Kantipudi, CEO, Aragen Life Sciences and Director of Aragen Biologics said, “Once the facility’s expansion is fully operational by the end of this calendar year, we will be able to do internal tech transfer from our R&D labs in California to the manufacturing site in India, thereby enabling end-to-end integrated service offering to customers.” Aragen currently offers discovery and development research services from its R&D labs in California, US. Services include cell line development, upstream and downstream development, protein science, and antibody discovery. The biologics manufacturing facility at Bengaluru will complement these services and will enable GMP and non-GMP manufacturing. It will have advanced single-use bioreactors with capacities ranging from 50 Ltr to 2000 Ltrs and will offer integrated solutions including process development, process validation, analytical development, small-scale manufacturing, large-scale DS manufacturing and stability services. ]]> https://biospectrumindia.com/news/97/24428/veeda-clinical-research-acquires-european-cro-heads-to-expand-global-reach.html https://biospectrumindia.com/news/97/24428/veeda-clinical-research-acquires-european-cro-heads-to-expand-global-reach.html Wed, 27 Mar 2024 00:00:00 +0530 Veeda Clinical Research, Ahmedabad-based full-service contract research organisation (CRO), has acquired Heads, a privately held European CRO, which specialises in conducting clinical trials in oncology. Established in 2010, Heads has operational presence in 25 multiple strategically important locations across Europe, North America and Asia Pacific region.  Through this acquisition, Veeda enters the league of global CROs with integrated capabilities to extend contract research services from discovery to clinical development extending to post commercial launch. The acquisition provides Heads a strong operational platform and an opportunity to expand its expertise and capabilities to the Indian and South-East Asian markets. India's diverse demographic profile provides a unique opportunity to conduct clinical trials, especially in therapeutic areas including oncology, diabetes, hypertension, infectious diseases, and special diseases. With this acquisition, Veeda’s global pharmaceutical and biotech clients can now leverage the unique and unparalleled suite of early to late-phase CRO services across Europe, US, and Asia Pacific. Veeda’s ever-growing relationship with large biopharma companies and access to key opinion leaders (KOLs) across multiple countries will accelerate execution of global clinical trials in both the western and eastern populations. ]]> https://biospectrumindia.com/news/97/24380/syngenes-biologics-manufacturing-facility-to-be-operational-for-us-and-european-customers-from-mid-2024.html https://biospectrumindia.com/news/97/24380/syngenes-biologics-manufacturing-facility-to-be-operational-for-us-and-european-customers-from-mid-2024.html Thu, 14 Mar 2024 00:00:00 +0530 Bengaluru-based Syngene International, a global contract research, development and manufacturing organisation (CRDMO), will be setting the operations of its newly upgraded biologics facility, Unit 3, for clinical and commercial supply in the second half of 2024. The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing. The drug substance capacity includes two production suites with five 2KL single use bioreactors each, for a total capacity of 20KL. The facility also includes two high-speed vial filling lines capable of producing up to 1 million vials per day ranging from 1 to 100mL fill volumes. In addition to the production capacity, the site has a development suite for clinical supply of drug substance equipped with a 500L single use bioreactor.   The facility triples Syngene’s bio manufacturing capacity and adds to its existing commercial manufacturing site in Bengaluru, BMP 1, which has been approved by the US FDA (with no 483 observations) and EMA, as well as a PROTAC research site in Hyderabad. Syngene has further expansion plans for two additional vial filling isolator lines with capacity for 600 vials/minute and 100 vials/minute respectively and drug substance expansion into perfusion cell culture processing. The $98 million manufacturing site is integrated with other biologics capabilities in the city including around 170 R&D scientists located nearby offering clients a seamless transition from discovery biology services into clinical and commercial manufacturing. The company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.  In total, Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene’s 600-strong team across its biologics manufacturing services and supporting specialist functions. ]]> https://biospectrumindia.com/news/97/24339/rx-propellant-locks-largest-life-sciences-real-estate-deal-in-india-at-rs-162-cr.html https://biospectrumindia.com/news/97/24339/rx-propellant-locks-largest-life-sciences-real-estate-deal-in-india-at-rs-162-cr.html Thu, 07 Mar 2024 00:00:00 +0530 In a deal that marks the tenancy of the single largest space within India’s life sciences real estate sector, Rx Propellant, the country’s leading Life sciences infrastructure platform, has leased a massive 1.3 lakh sq.ft. of state-of-the-art R&D facility - Nextopolis to GV Research Platform (GVRP), an integrated contract research organisation (CRO) in the biopharma industry. The deal, sealed by Rx Propellant for Rs 162 crore will allow NABL-accredited research organisation an occupancy for 10 years. Nextopolis, located in Hyderabad’s Genome Valley, is developed by Modi Properties and will enable GVRP to expand its service portfolio and consolidate all complementary offerings under one roof. Nextopolis offers customised infrastructure solutions suitable for the pharmaceutical and biotech firms. The facility boasts of sustainable infrastructure and world-class facilities including EV charging stations, high side HVAC system (including chillers), effluent pre-treatment plant, sewage treatment plant, compressed gas and vacuum lines, fire alarm and suppression systems, among others. The premise also has recreational spaces, including an open amphitheater. Rx Propellant has a portfolio of seven projects in the Genome Valley cluster totaling ~2.5 Mn sq.ft. These projects feature advanced labspaces and agile flexi-factories. Rx Propellant’s life sciences real estate portfolio comprises nine projects with over 6.5 million sq.ft. under development in Hyderabad, Bengaluru, and Mumbai. ]]> https://biospectrumindia.com/news/97/24296/suven-announces-merger-of-cohance-lifesciences-forging-integrated-pharma-cdmo-leadership-in-india.html https://biospectrumindia.com/news/97/24296/suven-announces-merger-of-cohance-lifesciences-forging-integrated-pharma-cdmo-leadership-in-india.html Thu, 29 Feb 2024 00:00:00 +0530 Hyderabad-based firms Suven Pharmaceuticals and Cohance Lifesciences have announced a proposed scheme of amalgamation for the merger of Cohance with Suven. This marks a pivotal moment in Suven's journey, underscoring its commitment to scaling, ensuring consistent earnings, fortifying financial standing, and advancing towards forging leadership in the integrated contract development and manufacturing organisation (CDMO) space. Cohance is a leading CDMO and Merchant API platform with global leadership in select low-mid volume molecules as well as unique capabilities in the form of its antibody drug conjugates (ADC) platform.  Merger shall establish Suven’s position as a diversified CDMO and API leader in India, transcending its current revenue base. The merged entity is expected to be amongst leading integrated CDMO players in India. With an expanded capacity to ~2,650 kL and a significantly broadened customer base, scale and synergy benefits are substantial. Upon the scheme becoming effective, all shareholders of Cohance will be issued shares of Suven at the ratio of 11 shares of Suven for every 295 shares of Cohance, based on the swap ratio. On the revenue front, the limited customer overlap will help with cross-selling opportunities, leveraging Cohance's capabilities to reach Suven customers and vice versa, e.g. leverage ADC platform and lifecycle management of key molecules for Suven customers.   ]]> https://biospectrumindia.com/news/97/24068/enzene-biosciences-launches-first-manufacturing-base-in-us.html https://biospectrumindia.com/news/97/24068/enzene-biosciences-launches-first-manufacturing-base-in-us.html Mon, 15 Jan 2024 00:00:00 +0530 Pune-based Contract Development & Manufacturing Organisation (CDMO), Enzene Biosciences has announced the launch of its first manufacturing site in the United States, located in Hopewell (near Princeton, New Jersey). The site is expected to be ready in June 2024, and customers have already started to reserve capacities for continuous manufacturing and/or fed batch. Designed to integrate the company’s patented EnzeneX continuous manufacturing technology platform, the plant is situated within the Princeton West Innovation Campus, at the heart of the US Northeast Corridor, within easy reach of several global biotech and pharmaceutical firms. This location is ideal for helping Enzene Biosciences serve emerging innovative, US-based biotech firms looking to benefit from the in-depth expertise in continuous manufacturing. Spread over 54,000 square feet, this plant will also hold the distinction of being one of the only biologics-focused continuous manufacturing bases to be set up by an Indian firm in the US. The company narrowed down on New Jersey because of its long tradition of supporting pharmaceutical manufacturing excellence. There is also ample availability of highly skilled talent in the region and Enzene Inc. is confident of securing skilled labour for sustained manufacturing operations over the longer term. Enzene Biosciences aims to gradually expand its operations across the five major markets for biologics and biosimilars, i.e. the EU, US, Canada, Australia, and Japan. ]]> https://biospectrumindia.com/news/97/23973/piramal-pharma-solutions-announces-opening-of-expanded-adc-manufacturing-facility-in-scotland.html https://biospectrumindia.com/news/97/23973/piramal-pharma-solutions-announces-opening-of-expanded-adc-manufacturing-facility-in-scotland.html Tue, 19 Dec 2023 00:00:00 +0530 Piramal Pharma Solutions (PPS), a Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma, celebrated the opening of its expanded antibody-drug conjugate (ADC) manufacturing facility in Grangemouth, Scotland, UK. This expansion further enhances the site's capacity by approximately seventy to eighty percent, enabling scale-up of commercial ADC manufacturing batches. The capacity expansion, which has been completed for commercialisation within this fiscal year, features two new ADC manufacturing suites specifically designed to complement the existing three. The commissioning of the facility represents the culmination of a £45 million investment to address rapidly growing demand for ADC manufacturing, supported by a £2.4 million Scottish Enterprise grant. The site expansion includes a dedicated customer experience centre for clients who are visiting the site during development and/or manufacturing activities, along with new Quality Control laboratories, warehousing, office space, and supporting utilities. The building, which utilised modular construction technology to expedite its completion, has been designed to accommodate further expansion. Potential future enhancements may include a new sterile fill/finish suite dedicated to ADCs and two additional large-scale manufacturing suites capable of handling increased batch sizes.  ]]> https://biospectrumindia.com/news/97/23857/astrazeneca-launches-health-tech-business-to-accelerate-delivery-of-clinical-trials.html https://biospectrumindia.com/news/97/23857/astrazeneca-launches-health-tech-business-to-accelerate-delivery-of-clinical-trials.html Tue, 21 Nov 2023 00:00:00 +0530 British pharmaceutical firm AstraZeneca has launched Evinova, set to be a leading provider of digital health solutions to better meet the needs of healthcare professionals, regulators and patients. With long-term backing from AstraZeneca and strategic collaborations with Parexel and Fortrea, Evinova offers globally-scaled digital products and services to the life sciences and healthcare sector.  Evinova will prioritise bringing to market established and scaled digital technology solutions already being used globally by AstraZeneca to optimise clinical trial design and delivery. This will reduce the time and cost of developing new medicines, bring care closer to home for patients and reduce the burden on health systems. Evinova will also pursue opportunities in digital remote patient monitoring and digital therapeutics with a pipeline of digital innovations in these areas. Drawing on AstraZeneca’s deep experience of developing novel therapeutics and with insights from thousands of patients and clinical researchers, Evinova will provide established technology solutions to pharma, biotech and contract research organisations (CROs) to support clinical research globally. The technologies have already been used in the successful delivery of multiple AstraZeneca-sponsored clinical trials in over 40 countries. ]]> https://biospectrumindia.com/news/97/23720/syngene-gains-access-to-ers-genomics-foundational-crispr-cas9-patent-portfolio.html https://biospectrumindia.com/news/97/23720/syngene-gains-access-to-ers-genomics-foundational-crispr-cas9-patent-portfolio.html Thu, 19 Oct 2023 00:00:00 +0530 ERS Genomics has completed licensing agreement with Syngene International, following which Syngene gains access to ERS Genomics' foundational CRISPR/Cas9 patent portfolio, ushering in a new era of technical innovation in India for its global partners.  Syngene International, an integrated research, development and manufacturing services company, is poised to leverage the immense potential of CRISPR/Cas9 in various scientific disciplines, including drug discovery, biotechnology, and genomics on behalf of its clients.  ERS Genomics, co-founded by Dr Emmanuelle Charpentier, a recipient of the 2020 Nobel Prize in Chemistry for her pioneering work on CRISPR/Cas9, provides access to the definitive patent portfolio for this groundbreaking technology. The collaboration between ERS Genomics and Syngene marks a significant addition to India's scientific and commercial landscape and reinforces the nation's growing influence in the global biotechnology and life sciences sector. Both organisations are focused on driving scientific progress and bringing transformative innovations to the forefront of research and development. Mahesh Bhalgat, Chief Operating Officer, Syngene International, said, "This partnership aligns perfectly with our mission to partner with clients to accelerate scientific discovery and support the development of life-changing therapies." ]]> https://biospectrumindia.com/news/97/23721/piramal-pharma-solutions-launches-in-vitro-biology-capabilities-at-ahmedabad-discovery-services-site.html https://biospectrumindia.com/news/97/23721/piramal-pharma-solutions-launches-in-vitro-biology-capabilities-at-ahmedabad-discovery-services-site.html Thu, 19 Oct 2023 00:00:00 +0530 Piramal Pharma Solutions (PPS), a leading pharmaceutical Contract Development and Manufacturing Organisation (CDMO), has officially announced the launching a world-class high-throughput screening facility that augments existing in vitro biology capabilities at its Drug Discovery Services facility in Ahmedabad. This new expansion significantly increases the primary and secondary screening capabilities of compounds prepared at the Ahmedabad site. With this expansion, Piramal Pharma Solutions is uniquely positioned to provide its customers with an integrated set of discovery capabilities and leverage a broad range of in vitro screening technology tools to support its extensive portfolio of research services. The goal is to generate data that constitutes a superior data set for customers and increase the company's value as an outsourcing partner.  The benefits of this new investment will result in an improved experience for PPS discovery services customers. Integrating chemistry and biology services under one roof promises to increase the efficiency of the discovery process. To enable this expansion, PPS is recruiting experienced staff with a proven track record in biology services, to complement existing technical and operational expertise. The new high-throughput screening format allows PPS to evaluate and screen large collections using various assay platform technologies, including TR-FRET (Time-Resolved Fluorescence Resonance Energy Transfer)/HTRF (Homogeneous Time -Resolved Fluorescence), Fluorescence Polarization (FP), Absorbance, Luminescence/Electrochemiluminescence (ECL), AlphaScreen, LanthaScreen, Flow Cytometry and High Content Imaging. These platforms will be applicable to a variety of targets, including G protein-coupled receptors (GPCRs) and kinases. ]]> https://biospectrumindia.com/news/97/23729/aragen-commissions-formulations-manufacturing-facility-in-hyderabad-set-up-with-3-m-investment.html https://biospectrumindia.com/news/97/23729/aragen-commissions-formulations-manufacturing-facility-in-hyderabad-set-up-with-3-m-investment.html Thu, 19 Oct 2023 00:00:00 +0530 Aragen, a leading provider of contract research, development, and manufacturing services for the pharmaceutical, biotechnology, agrochemicals and animal health industries, has commissioned its new formulations manufacturing facility in Hyderabad. This state-of-the-art facility, set up at an investment of $3 million, is located at the Mallapur Campus in Hyderabad and spans over 12,000 square feet area. It is equipped to support the clinical manufacturing of a wide range of dosage forms, including oral solids, liquids, topicals, and films.  Manni Kantipudi, CEO, Aragen Life Sciences, commented "With this expansion, we can offer our customers an even broader range of services, from early-stage development to clinical manufacturing, all from a co-located facility." The facility is equipped with a comprehensive suite of formulation technologies, including wet granulation, roller compaction, film coating, spray drying, tableting, capsule filling, bottle filling, and blister packing. It has been strategically designed to accommodate the addition of nano-milling and hot melt extrusion capabilities by next year, ensuring that Aragen stays at the forefront of pharmaceutical innovation. The facility has been inspected and approved by Indian regulators, the Central Drugs Standard Control Organisation (CDSCO) and the Drug Control Administration (DCA). It can accommodate flexible batch sizes ranging from 1,000 doses to 100,000 doses for solid orals and from 1 litre to 100 litres for liquids and will have a team of about 60 staff operating the facility.   ]]> https://biospectrumindia.com/news/97/23698/cepi-to-harness-iqvias-expertise-in-implementing-global-clinical-research-strategies.html https://biospectrumindia.com/news/97/23698/cepi-to-harness-iqvias-expertise-in-implementing-global-clinical-research-strategies.html Mon, 16 Oct 2023 00:00:00 +0530 IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services, and The Coalition for Epidemic Preparedness Innovations (CEPI) have announced a strategic collaboration to advance the 100 Days Mission. In conjunction with national and regional collaborators, CEPI and IQVIA will aim to enhance the world’s preparedness to rapidly conduct life-saving clinical research for vaccines and other biological countermeasures against emerging infectious diseases. CEPI will harness IQVIA’s extensive clinical research expertise and innovative solutions, as well as its global reach, to support its goal of strengthening pandemic preparedness clinical research capability in Low- and Middle-Income Countries (LMICs) to accelerate vaccine development when faced with future viral threats.   As part of its mission to enable faster and more equitable responses to future viral threats, CEPI will support the establishment of regional consortia, comprised of and led by national and regional stakeholders, to bolster research preparedness across LMICs. The regional consortia will identify gaps and needs in regional clinical research capability, and oversee the building of sustainable research capacity that can be swiftly put into action to respond to infectious disease outbreaks. IQVIA will play a crucial role as a global service provider, utilising its global reach and bandwidth to support the regional consortia and CEPI to fill gaps that will accelerate the generation of high-quality data during an outbreak response.  ]]> https://biospectrumindia.com/news/97/23667/cytiva-opens-new-manufacturing-facility-and-experience-centre-in-india.html https://biospectrumindia.com/news/97/23667/cytiva-opens-new-manufacturing-facility-and-experience-centre-in-india.html Thu, 05 Oct 2023 00:00:00 +0530 As India works to become a biologics manufacturing hub, global life sciences leader Cytiva is expanding with the opening of a 33 000 sq ft manufacturing facility in Pune. The new facility will manufacture Cytiva’s bioprocessing equipment including tangential flow, virus filtration, and inactivation systems. The facility will also be home to the Cytiva Experience Centre which will provide immersive training programmes for upstream and downstream technologies as well as digital and automation software. Additionally, customers will have greater access to thought leadership events and to demonstrations of Cytiva’s market-leading products, such as ÄKTA, Allegro, iCELLis and Sepax.  Located at Hinjawadi Rajiv Gandhi Infotech Park, this new facility complements Cytiva’s existing facilities in Bengaluru which include a Fast Trak Centre, and a centre for research and development across bioprocess, discovery, medical, and genomic medicine businesses.  According to Cytiva’s 2023 Global Biopharma Resilience Index, 65% of biopharma executives in India say that the manufacturing of biologics in their country is likely to dramatically increase over the next three years. This is 15% higher than the global average, and in line with India’s National Biopharma Mission to make India a hub for the development of novel and affordable vaccines and biologics to address the population’s health concerns. Additionally, 46% of biopharma executives in India say that they are focusing on onshoring drug manufacturing or increasing domestic sourcing over the next 12 months to boost supply chain resilience. However, 20% of executives say that access to new equipment has become worse over the last two years, indicating a need to improve local access to equipment so that Indian companies can deliver affordable life-changing therapeutics domestically and to the region.     ]]> https://biospectrumindia.com/news/97/23668/sai-life-sciences-selects-dassault-systmes-solutions-to-accelerate-drug-discovery.html https://biospectrumindia.com/news/97/23668/sai-life-sciences-selects-dassault-systmes-solutions-to-accelerate-drug-discovery.html Thu, 05 Oct 2023 00:00:00 +0530 French multinational firm Dassault Systèmes has announced that Sai Life Sciences, Hyderabad-based contract research, development, and manufacturing organisation has selected Dassault Systèmes’ solutions to enhance productivity, elevate data quality, and foster collaboration within Sai Life Sciences Research and Process Development laboratories leading to accelerated drug discovery. Sai Life Sciences is using Dassault Systèmes' industry solution experience “ONE Lab” based on the 3DEXPERIENCE platform. The solution, which leverages BIOVIA applications, helps optimise productivity, ensure data accuracy and data security, and enable seamless data accessibility and analysis. The company has implemented “ONE Lab” to bolster security measures, and facilitate effortless data access and analysis.  Utilising “ONE Lab,” Sai Life Sciences is creating an integrated digital platform for its research and development (R&D) and chemistry, manufacturing and controls (CMC) laboratories, effectively tackling some of the most notable challenges ailing the research in this sector, specifically associated with project implementation. The primary objectives of this selection encompass error reduction, time-saving, the promotion of sustainability practices, and the establishment of a unified, reliable source of information to facilitate multi-stakeholder collaboration spanning research, development and commercial manufacturing. ]]> https://biospectrumindia.com/news/97/23591/akums-launches-drug-for-enlarged-prostate-erectile-dysfunction-treatment.html https://biospectrumindia.com/news/97/23591/akums-launches-drug-for-enlarged-prostate-erectile-dysfunction-treatment.html Thu, 14 Sep 2023 00:00:00 +0530 Akums Drugs and Pharmaceuticals, New Delhi-based contract manufacturing and development organisation (CDMO), has introduced an advancement in healthcare — the Tamsulosin + Tadalafil Capsule — to the Indian market. This innovative combined therapy, delivered in a fixed dose combination within a hard gelatin capsule, marks an important achievement for the company. Notably, Akums has become the first CDMO to obtain approval for the unique formulation of Tamsulosin 0.4/0.4mg + Tadalafil 2.5/5mg, as sanctioned by the Drug Controller General of India (DCGI). Tamsulosin is a selective alpha1A-adrenergic receptor antagonist. The effects of tamsulosin are targeted for the smooth muscle receptors of the prostate and urethra. Blocking this receptor relaxes the smooth muscle of the bladder and urethra to improve urine flow. It is primarily used when an enlarged prostate impedes normal urine flow and bladder emptying. In tandem, the mechanism of action for Tadalafil centers on the inhibition of PDE5, a crucial enzyme located in the vascular smooth muscle cells of corpus cavernosum. By impeding cGMP hydrolysis, Tadalafil promotes cGMP accumulation and the relaxation of vascular smooth muscle, facilitating the development of a physiologically-induced erection, contingent upon sexual stimulation.     ]]> https://biospectrumindia.com/news/97/23549/cdmo-player-enzene-biosciences-opens-new-rd-centre-in-pune.html https://biospectrumindia.com/news/97/23549/cdmo-player-enzene-biosciences-opens-new-rd-centre-in-pune.html Tue, 05 Sep 2023 00:00:00 +0530 Enzene Biosciences, a subsidiary of Mumbai-based Alkem Laboratories, has announced the inauguration of its cutting-edge research and development (R&D) facility in Pune. Enzene, a leading biopharmaceutical company offering integrated Contract Development and Manufacturing (CDMO) services for Biologics, has opened a new R&D facility spanning over 75,000 square feet, and is equipped with an open lab set-up that promotes cross-departmental collaboration, efficient communication, and knowledge sharing. The facility showcases Enzene's dedication to advancing scientific research and development, offering fully integrated services from Cell Line Development to Fill & Finish across a wide range of modalities. Within the new R&D facility, Enzene has established specialised departments, including Cell Line Engineering (CLE), Drug Product Development (DPD), Purification Process Development (PPD), Advanced Analytical Technology (AAT), and Bioanalytical Assay. These departments bring together a team of highly skilled scientists and researchers with affiliations to esteemed institutions like Massachusetts Institute of Technology, University of Tennessee Medical Centre among others and prior experience at globally renowned companies. Enzene aims to further strengthen its partnership with CDMO clients by providing them with access to cutting-edge technologies and an extended portfolio of services. In terms of drug development continuum, Enzene will soon start offering biologics discovery services to its partners. ]]> https://biospectrumindia.com/news/97/23528/aryastha-life-sciences-secures-series-a-funding-from-vessella-group.html https://biospectrumindia.com/news/97/23528/aryastha-life-sciences-secures-series-a-funding-from-vessella-group.html Tue, 29 Aug 2023 00:00:00 +0530 Hyderabad-based Aryastha Life Sciences, a leading Contract Research and Development Organisation in healthcare, has achieved a major milestone by successfully concluding its Series A funding with significant backing from Vessella Group, a prominent investor in India. A strategic funding boost from Vessella positions Aryastha to reshape drug discovery and development in the pharmaceutical and biotech sectors. With a vision to provide exceptional solutions for unmet clinical needs, Aryastha leverages cutting-edge R&D infrastructure in India and plans expansion in the USA. Aryastha aims to differentiate as a pioneer, utilising artificial intelligence (AI), advanced preclinical models derived from patient samples and  pluripotent stem cells  'Aryastha's Bio Solutions' for efficient drug screening. This innovative approach accelerates the clinical translatability of candidates, streamlining services across the value chain and addressing pharmaceutical industry challenges. With cutting-edge facilities and a skilled team, Aryastha cultivates an environment of innovation. Partnering with Vessella Group offers a unique chance for impactful change in healthcare. Vessella's investment acknowledges outsourcing's significance in drug discovery and development, aligning with Aryastha's expertise. Guided by visionary leadership, Aryastha is poised to advance scientific solutions and provide quality healthcare services.   ]]> https://biospectrumindia.com/news/97/23482/mysurus-vipragen-biosciences-receives-second-investment-round-from-karnataka-governments-venture-fund.html https://biospectrumindia.com/news/97/23482/mysurus-vipragen-biosciences-receives-second-investment-round-from-karnataka-governments-venture-fund.html Tue, 22 Aug 2023 00:00:00 +0530 "We are thrilled to receive this investment from KITVEN and Conscience Multi Family Office," said Dr. Chandrashekaran. "This funding will empower us to further enhance our operations and expand our reach into new sectors, such as Nutraceuticals, Agrochemicals and Medical Devices. With a surge of interest in global strategic partnerships within the preclinical CRO space, Vipragen is uniquely positioned to capitalize on its niche expertise and solid business foundation.   Mr. Jayakumar CEO KITVEN said “Vipragen with its world class facilities and range of service offerings is on the threshold of becoming one of the leading CRO providers for Pharmaceutical companies and research organisations'. Commenting on the transaction, Vignesh Sundararaman, Founding Partner at Conscience MFO, stated, "The preclinical CRO landscape has witnessed a significant uptick in M&A activities, highlighting the value of specialized expertise and quality services. We are excited to join forces with Vipragen and contribute to its growth trajectory." QuantAscend Consulting Global, our CFO Advisors, led and advised the investment transaction. Vipragen had previously received funding from KITVEN and benefitted from collaborative projects supported by BIRAC. Incubated at the Centre for Cellular and Molecular Platforms (CCAMP) in Bangalore, this fund will empower Vipragen to scale up its current operations and explore new horizons in Nutraceuticals, Agrochemicals and Medical Device sectors. Dr. Chandrashekaran, Founder Chairman of Vipragen, expressed optimism about India's growing prominence as a global research hub, stating, "Our vision is to attract more international companies to leverage India's thriving research ecosystem." ]]> https://biospectrumindia.com/features/97/23440/discovering-the-right-partnership-for-novel-drugs.html https://biospectrumindia.com/features/97/23440/discovering-the-right-partnership-for-novel-drugs.html Mon, 07 Aug 2023 00:00:00 +0530 With a worth of around $113 billion by 2032, the global drug discovery market is primarily driven by the rising prevalence of various diseases such as cardiovascular diseases, diabetes, cancer, respiratory diseases, and neurological disorders, which is significantly fuelling the demand for new and innovative drugs. Although North America is the largest market for drug discovery, Asia-Pacific (APAC) region is close behind, emerging as the fastest-growing market in this space. According to a recent report by GlobalData, five drugs set for approval in 2023 are projected to attain blockbuster or near-blockbuster status by 2028, with US companies in dominance, followed by Japan. The US market undoubtedly holds a commanding position in the drug discovery space. Still, the entire credit does not go to Big pharma companies, as they are now on the hunt for contract research organisations (CROs) or contract development and manufacturing organisations (CDMOs) who can give more intellectual inputs rather than traditional services. The surge in the global demand for outsourcing services or bioservices for drug discovery is another major factor spurring the growth of the global drug discovery market. Amongst numerous players in the global CRDMO space, many Indian companies have now become a preferred choice for big pharma firms to streamline their drug discovery process. Companies such as Aragen Life Sciences, Syngene, Piramal Pharma Solutions, Anthem Biosciences, Aurigene etc., are some of the leading names that are playing a critical role in the process of new drug development globally. Not just the big end-to-end service providers but small CROs with specific capabilities are also in great demand from those pharma companies looking for expertise in niche therapeutic areas. Such partnerships are also being sought after by drug developers for early-stage development as well as for specialised products. And the role of technology is going hand-in-hand with these developments to expedite the drug invention process. For example, Hyderabad-based Aragen Life Sciences has recently partnered with FAR Biotech, a US-based, artificial intelligence (AI)-driven, computational drug discovery company, to advance preclinical programmes in neurodegeneration. On the other hand, Bengaluru-based Syngene has developed Artificial Intelligence (AI) solutions that enable informed decisions in drug discovery and development through learning from historical data and data generated as the project progresses from target identification to final candidate selection. Likewise, there are other players in the Indian life sciences market, such as New Delhi-based startup Molecule AI which is developing an innovative AI-based platform for drug discovery with a strong focus on data engineering and generative AI models. Such players are emerging as partners for both the bioservices and the pharma sector, offering a perfect model of collaboration to support not only ‘Make in India’ but ‘Invent in India’ initiatives! Molecule AI’s platform has generated considerable interest in potential partnerships from prominent players in the pharma/biopharma space. Although the smaller players in the bioservices sector cannot provide an entirely strategic outsourcing solution to the big pharma players, these entrepreneurial ventures have the benefit of less bureaucracy and greater speed. And they possess a solid depth of expertise, too, which makes the association with smaller players very valuable, particularly for many pharma and biotech companies. ]]> https://biospectrumindia.com/news/97/23397/akums-gets-dcgi-approval-for-triple-combination-diabetes-treatment.html https://biospectrumindia.com/news/97/23397/akums-gets-dcgi-approval-for-triple-combination-diabetes-treatment.html Wed, 26 Jul 2023 00:00:00 +0530 New Delhi-based contract development and manufacturing organisation Akums Drugs and Pharmaceuticals has secured approval from the Drug Controller General of India (DCGI) for its groundbreaking triple combination diabetes treatment. Sitagliptin 100, Pioglitazone 15 and Metformin 1000/500 comes as a more advanced treatment for diabetes, with much more efficacy and precision than monotherapy drugs that are currently in the market. Sitagliptin 100, Pioglitazone 15 and Metformin 1000/500 is specifically formulated for the treatment of diabetes and offers a number of pharmacological advantages. The combination contains three distinctly active formulations such as Metformin, a glucose-lowering agent often prescribed as a first-line therapy for Type-2 diabetes (T2D). Pioglitazone, on the other hand, is an outstanding component as it is considered effective against T2D because of its ability to improve insulin sensitivity, lower HbA1c levels, and promote lipid metabolism and insulin secretion. The third component in the combination is Sitagliptin, which has been observed to significantly reduce HbA(1c) levels when used as an add-on therapy after the administration of insulin, sulfonylureas, or thiazolidinediones, or alone with or without metformin. "We have carefully studied the pharmacological properties of these formulations and with Sitagliptin 100, Pioglitazone 15 and Metamorfin 1000/500, we found the right blend for our triple-active combination. This is going to better serve anti-diabetic patients who require better treatment without necessarily swallowing multiple drugs, " said Sanjeev Jain, Jt. Managing Director, Akums Drugs & Pharmaceuticals.     ]]> https://biospectrumindia.com/news/97/23286/syngene-to-acquire-multi-modal-facility-from-stelis-biopharma-for-rs-702-cr.html https://biospectrumindia.com/news/97/23286/syngene-to-acquire-multi-modal-facility-from-stelis-biopharma-for-rs-702-cr.html Wed, 05 Jul 2023 00:00:00 +0530 Syngene has announced the acquisition of Unit 3 biologics manufacturing facility in Bangalore, from Stelis Biopharma Limited (SBL). The companies have entered into a binding term sheet and, on completion of the transaction, the site will add 20,000 liters of installed biologics drug substance manufacturing capacity for Syngene. The site has the potential for future expansion up to a further 20,000 liters of biologics drug substance manufacturing capacity. It also includes a commercial scale, high speed, fill-finish unit – an essential capability for drug product manufacturing. Syngene will acquire Unit 3 on a slump sale basis for a gross value of Rs 702 crore ($86 Million). Subject to closing adjustments, the consideration for the transaction will be settled in cash.  The facility, which was initially built to manufacture Covid-19 vaccines, is now being repurposed to manufacture monoclonal antibodies and Syngene will further invest up to Rs 100 crore ($12 Million) to repurpose and revalidate the facility. Jonathan Hunt, Managing Director and Chief Executive Officer said, “We expect this facility to be operational in 2024, following completion of a programme of facility upgrades and re-validation.” The facility covers both drug substance and drug product with installed capacity of 10 bioreactors of 2000L along with associated infrastructure and utilities. The facility also includes 10 additional uninstalled bioreactors - providing the potential for future expansion - and two high speed fill-finish lines. ]]> https://biospectrumindia.com/news/97/23267/akums-strengthens-position-in-cns-market-with-first-time-dcgi-approval-for-epilepsy-treatment.html https://biospectrumindia.com/news/97/23267/akums-strengthens-position-in-cns-market-with-first-time-dcgi-approval-for-epilepsy-treatment.html Wed, 28 Jun 2023 00:00:00 +0530 Akums, New Delhi-based Contract Development and Manufacturing Organisation (CDMO), has announced the first-time approval of Perampanel Oral Suspension by the Drug Controller General of India (DCGI). This groundbreaking approval allows Perampanel Oral Suspension to serve as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalised seizures, as well as primary generalised tonic-clonic (PGTC) seizures in patients with epilepsy aged 12 years and older in the country. The Perampanel Oral Suspension is a bioequivalent formulation to the US FDA approved FYCOMPA (perampanel) Oral Suspension. According to a report by the World Health Organisation (WHO) around 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally. An estimated 5 million people are diagnosed with epilepsy every year. India has more than 10 million patients with epilepsy, i.e., 20% out 50 million worldwide. The newly approved Perampanel Oral Suspension formulation is now available in 100 ml bottles, with a strength of 0.5mg/ml. The packaging includes a convenient oral dosing applicator ensuring accurate dosage administration and enhancing patient compliance. Akums' achievement in obtaining the DCGI approval for Perampanel Oral Suspension further solidifies its position as a leader in the Central Nervous System (CNS) category. ]]> https://biospectrumindia.com/news/97/23251/anthem-biosciences-partners-with-veeva-to-accelerate-availability-of-new-medicines.html https://biospectrumindia.com/news/97/23251/anthem-biosciences-partners-with-veeva-to-accelerate-availability-of-new-medicines.html Thu, 22 Jun 2023 00:00:00 +0530 US-headquartered Veeva Systems has announced that fast-growing contract development and manufacturing organisation (CDMO) Anthem Biosciences has selected Veeva Vault Quality Suite as the digital foundation to drive quality excellence across its research and manufacturing facilities. With Vault Quality Suite, Bengaluru-based Anthem Biosciences will have connected systems that can simplify quality, content, and training management. Anthem is adopting Veeva Vault QMS, Vault QualityDocs, and Vault Training for greater visibility and insights into operational efficiency across its biological- and chemistry-based products and services. Using applications on a single platform will enable easier collaboration with stakeholders while delivering transparency to Anthem's customers, auditors, and regulatory agencies. The Veeva Vault Quality Suite includes Veeva Vault QualityDocs, Veeva Vault QMS, Veeva Vault Training, Veeva Vault Validation Management, Veeva Vault LIMS, and Veeva LearnGxP to automate and harmonize quality processes globally. ]]> https://biospectrumindia.com/news/97/23229/akums-announces-first-central-warehousing-project-in-sidcul-industrial-estate-haridwar.html https://biospectrumindia.com/news/97/23229/akums-announces-first-central-warehousing-project-in-sidcul-industrial-estate-haridwar.html Mon, 19 Jun 2023 00:00:00 +0530 Akums, a leading provider of cost-effective and timely manufacturing solutions in the pharmaceutical industry, has announced its pioneering central warehousing pilot project located in the SIDCUL Industrial Estate, Haridwar, this initiative represents a significant milestone in Akums' commitment to delivering cutting-edge solutions to the pharmaceutical sector. Under the visionary leadership of Sanjeev Jain and Sandeep Jain, the company has consistently provided innovative contract development and manufacturing organisation (CDMO) services. In the past, Indian pharma companies had to rely on foreign sources to meet their manufacturing and research-oriented needs.  Traditionally, factories have prioritised expanding their core production areas, neglecting the optimization of finished goods storage space. Acknowledging this gap, Akums' senior management has dedicated substantial time to address storage challenges and develop in-house expertise. The first phase of the project comprises a built-up area of 30,610.2 sq. mtr., including a ground coverage of 28,215.61 sq. mtr., with 17 standalone blocks dedicated to pharmaceutical FG storage. Akums has embarked on this groundbreaking central warehousing pilot project, to enhance operational efficiency and meet the evolving demands of the pharmaceutical industry. ]]> https://biospectrumindia.com/news/97/23222/enzene-biosciences-invests-50-m-to-open-new-bio-manufacturing-plant-in-us.html https://biospectrumindia.com/news/97/23222/enzene-biosciences-invests-50-m-to-open-new-bio-manufacturing-plant-in-us.html Fri, 16 Jun 2023 00:00:00 +0530 Enzene Biosciences, a global biotech company based in Pune, will open its state-of-the-art biopharmaceutical manufacturing plant on the Princeton West Innovation Campus in Hopewell. Operations in the new facility, the company’s first location outside of India, are expected to begin in June 2024. As a Contract Development and Manufacturing Organization (CDMO), Enzene Biosciences, a subsidiary of Alkem Laboratories, provides services to global pharmaceutical companies, partnering with them in their drug development and manufacturing processes. As part of Enzene’s expansion plans, the company will initially hire 50 employees and grow to 300 employees at its New Jersey facility.  Indian companies are increasingly establishing a strong presence in New Jersey by capitalising on the state’s favorable business environment. New Jersey has long been acknowledged as a national leader in life sciences, and Enzene’s expansion is yet another example of Indian companies finding their footing in the state.  Enzene’s local manufacturing capabilities will provide North American biopharmaceutical companies with streamlined supply chains, fast turnaround times, enhanced communication, and greater control over the manufacturing process. By providing comprehensive manufacturing capabilities under one roof, Enzene is well-positioned to support the development and production of a diverse range of biologics, contributing to the advancement of global healthcare and positively impacting patients’ lives worldwide.   ]]> https://biospectrumindia.com/news/97/23164/aragen-life-sciences-far-biotech-to-advance-preclinical-programme-in-neurodegeneration.html https://biospectrumindia.com/news/97/23164/aragen-life-sciences-far-biotech-to-advance-preclinical-programme-in-neurodegeneration.html Wed, 31 May 2023 00:00:00 +0530 Aragen Life Sciences (Aragen), a leading Contract Research and Development Organization (CRO) based in Hyderabad, and FAR Biotech (FAR), a US-based, artificial intelligence (AI)-driven, computational drug discovery company, have announced a collaboration to advance preclinical programmes in neurodegeneration. As part of the collaboration, Aragen will deploy its proven experimental discovery platform to help FAR advance its small molecule program towards an important milestone in neurodegeneration.  “We look forward to initiating our collaboration with FAR Biotech to advance its pipeline of therapeutic candidates,” said Dr Ramesh Subramanian, Chief Commercial Officer, Aragen. “Aragen has developed strong capabilities in providing integrated drug discovery (IDD) solutions to its customers to accelerate their discovery programs and this collaboration marks an inflection point for our IDD vertical.”  Commenting further, Dr Simon Haydar, SVP & Head of Integrated Drug Discovery, Aragen, added, “We are encouraged by the in-silico molecules we’ve seen coming out of FAR Biotech over the past several months and look forward to helping them advance their neurodegeneration program. We are confident that the outcome will be novel therapeutic candidates for a high-impact target that has proven hard to drug.”  Dr Martin Martinov, CEO, FAR Biotech, stated, “A key therapeutic area for FAR Biotech is neurodegeneration, where we believe our computational approach can deliver structurally diverse, novel molecules that move us closer to overcoming Alzheimer’s, Parkinson’s and other related diseases that have thus far proven intractable.     ]]> https://biospectrumindia.com/news/97/23048/india-emerging-as-favourable-destination-to-conduct-clinical-trials-pwc-usaic-report.html https://biospectrumindia.com/news/97/23048/india-emerging-as-favourable-destination-to-conduct-clinical-trials-pwc-usaic-report.html Wed, 03 May 2023 00:00:00 +0530 Through several key drivers, India is emerging as a favourable destination to conduct clinical trials, as per a joint report by PwC India & USAIC (US-India Chamber of Commerce) titled, “Clinical Trial opportunities in India”. The report was released at the USAIC BioPharma & Healthcare Summit held virtually on May 3. Biopharma can benefit from the critical enablers of innovation in the private healthcare system in India and leverage the rapidly expanding healthcare infrastructure in the country.  According to the report, the private sector is a well-suited channel for the top biopharma to conduct more efficient clinical trials with easier and faster access to investigators and patients. Indian states with high disease prevalence (e.g., cancer) also have the most number of tier-1 cities, with advanced medical infrastructure and availability of investigators. Targeting these states can provide biopharma companies with faster access to patients, sites, and investigators. India has an overall clinical trial participation of ~3% but contributes upwards of 15% to the global burden of most high prevalent diseases (e.g., respiratory infections, cardiovascular, diabetes, cervical cancer), representing an untapped potential for top pharma. Top biopharma should align their strategy towards tier-1 cities (e.g., Mumbai, Delhi, Bengaluru, Chennai) where the higher bed capacity, number of doctors, and presence of tertiary care multi-city hospitals can support enablement efforts of running faster and more efficient clinical trials. ]]> https://biospectrumindia.com/news/97/22983/sai-life-sciences-opens-research-facility-for-schrdinger-at-hyderabad-rd-campus.html https://biospectrumindia.com/news/97/22983/sai-life-sciences-opens-research-facility-for-schrdinger-at-hyderabad-rd-campus.html Fri, 21 Apr 2023 00:00:00 +0530 Sai Life Sciences, one of India's fastest growing global Contract Research, Development & Manufacturing Organisations (CRO-CDMO), has announced the opening of Sai Schrödinger Research Laboratories (SSRL) at its R&D campus in Hyderabad. The facility was inaugurated by Dr Karen Akinsanya, President of R&D, Therapeutics at Schrödinger Inc. (based in the US), in the presence of members of the leadership team of Schrödinger and Sai Life Sciences. In January 2023, Sai Life Sciences entered into a 5-year strategic agreement with Schrödinger, whose physics-based computational platform is transforming the way therapeutics and materials are discovered, to set up SSRL in Hyderabad. Soon after, Sai Life Sciences commenced the build-up of the facility along with recruitment of scientific staff, to drive the project to completion in an accelerated time frame. Set up inside Sai Life Sciences' R&D campus in Genome Valley, SSRL is a dedicated facility for integrated discovery work streams including medicinal & synthetic chemistry, in vitro biology, and process chemistry. SSRL will access other Sai capabilities such as in vitro ADME (Absorption, distribution, metabolism, and excretion) and in vivo PK (pharmacokinetics) as needed. The relationship will support advancement of programmes that leverage Schrödinger's validated computational platform. Currently, SSRL has 75 employees across full-time-equivalents (FTEs) in Medicinal Chemistry, Biology, Process Chemistry and Analytical Chemistry.  ]]> https://biospectrumindia.com/news/97/22969/ahmedabad-based-clro-lambda-therapeutics-deploys-medidatas-cloud-based-clinical-solutions-.html https://biospectrumindia.com/news/97/22969/ahmedabad-based-clro-lambda-therapeutics-deploys-medidatas-cloud-based-clinical-solutions-.html Wed, 19 Apr 2023 00:00:00 +0530 US-based firm Medidata, a wholly owned subsidiary of Dassault Systèmes, has announced that Lambda Therapeutics is implementing Medidata's cloud-based clinical solutions – Rave EDC, Rave RTSM, and Rave Imaging. This will further augment their clinical trial efficiency by automating and streamlining data management workflows, and securely delivering higher quality data for faster insights. Lambda Therapeutics, a Clinical Research Organisation (CLRO) headquartered in Ahmedabad, has facilities and operations in North America (the USA and Canada) and Europe (London, and Warsaw, Poland). It offers a full spectrum of clinical trial solutions including Phase 2 to 4 late phase clinical efficacy and safety patient-based trials, early phase development, NCE trials, large molecule biosimilar assay development labs, data management, drug safety and pharmacovigilance and medical imaging, with more than 20 years of experience. The implementation allows both companies to offer their global clients a single unified platform that optimizes workflows, mitigates risk, cuts development costs, and secures data integrity. Rave Imaging's intelligent workflows simplify image and data collection and are configured to immediately perform edit checks and de-identification during the image upload process. The system then automates the distribution and review process after upload as per the protocol design. ]]> https://biospectrumindia.com/news/97/22973/jubilant-ingrevia-commissions-new-acetic-anhydride-plant-in-gujarat.html https://biospectrumindia.com/news/97/22973/jubilant-ingrevia-commissions-new-acetic-anhydride-plant-in-gujarat.html Wed, 19 Apr 2023 00:00:00 +0530 Jubilant Ingrevia has announced the commissioning of its new global scale Acetic Anhydride plant, at its manufacturing facility in west India at Bharuch, Gujarat. This plant adds around 60,000 MT of capacity, whereby scaling Jubilant Ingrevia’s overall annual Acetic Anhydride capacity to 210,000 MT. This enhanced capacity will also help the company to increase its global presence in various geographies and achieve leadership position in the global merchant markets. In the domestic market it further strengthens and consolidates Jubilant Ingrevia’s position as a market leader. With this additional capacity, Jubilant Ingrevia also provides opportunity to its global customers to further expand their downstream products across end-user industries viz. Pharmaceuticals, Agrochemicals, Food, Vitamins, Wood Acetylation, Electronics, Dyes industry  etc. Acetic anhydride is a key raw material required in the production of medicines, such as acetylsalicylic acid (aspirins), sulfa drugs, certain vitamins and hormones, acetyl-p-aminophenol, cortisone, acetanilide, theophylline, acetylcholine hydrochloride, acetophenacetin, sulfonamides, and paracetamol. The global acetic anhydride market attained a value of $3.05 billion in 2022 and is expected to reach a value of $4.06 billion by 2028.   ]]> https://biospectrumindia.com/news/97/22810/sai-life-sciences-sets-up-gmp-kilo-lab-in-manchester-uk.html https://biospectrumindia.com/news/97/22810/sai-life-sciences-sets-up-gmp-kilo-lab-in-manchester-uk.html Wed, 15 Mar 2023 00:00:00 +0530 Sai Life Sciences, a leading global Contract Research, Development & Manufacturing Organisation (CRO-CDMO) based out of Hyderabad, has announced the setting up of a GMP Kilo Lab at its facility in Alderley Park, Manchester, UK. The new GMP Kilo Lab will enable Sai Life Sciences to offer drug substance and intermediates supplies ranging from gram to kilogram quantities to meet customer clinical requirements at an accelerated pace. Being offered both, as a standalone facility as well as part of an integrated service together with its capabilities in India, the lab consists of one process stream including two vessels of up to 35 L capacity with provision to add more streams in future. It is supported with associated contained filtration & drying equipment and is engineered to provide containment level of 1μg/m3. The lab also offers analytical method validation and analytical services to support batch release, in additional to stability studies to enable rapid regulatory filing. Over the past three years, the company has made investments of over $120 million as part of its SaiNxt initiative, to augment capacity, scale up operations, expand into new geographies, grow its scientific talent base, and raise the overall bar for quality, compliance, and performance. ]]> https://biospectrumindia.com/news/97/22786/akums-collaborates-with-fermenta-biotech-to-manufacture-areola-cream-for-breastfeeding-mothers.html https://biospectrumindia.com/news/97/22786/akums-collaborates-with-fermenta-biotech-to-manufacture-areola-cream-for-breastfeeding-mothers.html Mon, 13 Mar 2023 00:00:00 +0530 Akums Drugs and Pharmaceutical, New Delhi-based contract development and manufacturing organisation (CDMO), has partnered with Thane-based Fermenta Biotech, a key global player, for manufacturing one-of-its kind Areola cream which soothes and protects sore & cracked nipples and adjoining area of breastfeeding moms. The collaboration is a step towards the betterment of women’s health in India, especially lactating mothers.  This is an exclusive collaboration and for the first time, an Areola cream for lactating mothers is being launched in India and globally. Lanolin is a natural moisturising waxy substance that is derived from Australian sheep wool and provides soothing protection for sore and delicate skin. The ultra-pure lanolin used in the cream is non-sensitising and hypoallergenic, which makes it completely natural and safe for babies. According to research, sore nipples associated with breastfeeding is a common problem with an incidence of 11% to 90%. It is due to poor positioning or attachment of the baby, abrupt detachment of the baby after feeding, skin sensitivity, hormonal changes causing breast tenderness, and climate variability. Its symptoms include redness, soreness, pain or discomfort, fissures, chapped, and dry appearance.  In a survey, sore and cracked nipples are among the top challenges quoted by Indian mothers for early weaning off breast feed.    The global sore nipple cream segment is growing at a CAGR of 11.4 percent (2019-25). While 78 percent of mothers prefer to breastfeed for at least a year, 40 percent of mothers have reported sore and cracked nipples as a major problem.    ]]> https://biospectrumindia.com/news/97/22760/akston-biosciences-universal-covid-19-vaccine-for-india-to-advance-with-new-cdmo.html https://biospectrumindia.com/news/97/22760/akston-biosciences-universal-covid-19-vaccine-for-india-to-advance-with-new-cdmo.html Wed, 08 Mar 2023 00:00:00 +0530 US-based Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, has ended its AKS-452 licensing, manufacturing, and commercialisation agreement with Stelis Biopharma, an arm of Strides Pharma Science, in Bengaluru. Akston has reclaimed all rights to AKS-452, a room temperature stable, low-cost, protein subunit COVID-19 vaccine. AKS-452 has completed a Phase II/III clinical trial in India, with data showing a robust safety profile and a 91% seroconversion rate at Day 56. Volunteers in the study had antibody titers that persisted at statistically-significant high levels through six months, with serum showing protection against variants of concern, including Delta and Omicron. Akston is now working with a new contract development and manufacturing organisation (CDMO) in India to produce the promising AKS-452 COVID “universal” booster release. The results of a Phase I/II randomized, open-labelled study in The Netherlands and published in Vaccine showed that seroconversion rates reached 100% with enhanced potencies of SP/RBD-ACE2 binding inhibition and live virus neutralization. Todd Zion, Ph.D., President & CEO of Akston Biosciences, said, “I am confident that AKS-452 can attain Emergency Use Authorisation (EUA) in India, especially as a ‘universal’ booster vaccine capable of increasing and broadening people’s immune response as their previous immunity wanes and new variants arise. We concluded that Akston and a different CDMO were better placed to move ahead the AKS-452 development plan at a rapid pace, so we reclaimed the rights.”     ]]> https://biospectrumindia.com/news/97/22718/enzene-biosciences-begins-commercial-supply-of-adalimumab.html https://biospectrumindia.com/news/97/22718/enzene-biosciences-begins-commercial-supply-of-adalimumab.html Tue, 28 Feb 2023 00:00:00 +0530 Pune-based biotechnology company Enzene Biosciences, a subsidiary of Alkem Laboratories, has begun commercial supplies of Adalimumab for treating Ankylosis Spondylitis (AS) and Rheumatoid Arthritis (RA). This is the company’s fourth Biosimilar launch in recent times and the company believes that this first commercial launch using continuous manufacturing technology will help in reducing the cost of RA treatment for millions of patients across India. Biosimilar medicines have an important role to play in increasing the affordability of treatments for various serious conditions such as cancer, rheumatoid arthritis, osteoporosis, etc. However, conventional biologics manufacturing process is extremely cost intensive, and despite the availability of biosimilars the access to these medicines still remains limited due to their high cost. Enzene is one of the first movers globally in developing fully integrated continuous manufacturing platform.  Adalimumab development included a comparative efficacy and safety studies in patients with Ankylosing spondylitis, also known as Marie-Strumpell disease or Bechterew's disease.     ]]> https://biospectrumindia.com/news/97/22677/akums-partners-with-lyrus-life-sciences-to-manufacture-products-for-global-markets.html https://biospectrumindia.com/news/97/22677/akums-partners-with-lyrus-life-sciences-to-manufacture-products-for-global-markets.html Wed, 22 Feb 2023 00:00:00 +0530 Akums Drugs and Pharmaceuticals, New Delhi-based contract development and manufacturing organisation has partnered with Lyrus Life Sciences for a number of patented technologies and formulations. Lyrus is a research and technology-driven global specialty pharmaceutical company based in Bengaluru. The unique treatments and therapies emerging from this world-class collaboration will ensure the launch of patented drugs and more patient-friendly formulations that are beneficial for patients. The products and technologies are carefully selected to address the unmet need in the areas of pain, obesity, diabetes, psoriasis, seasonal flu, respiratory insufficiency, immunity,  and women’s health with a special focus on the geriatric and pediatric population. Managing Director of Akums, Sanjeev Jain shared that the partnership comes at a vital time in the company's journey when there is a need to launch differentiated formulations with global patents thus providing an edge. C.P. Bothra, Chairman of Lyrus Life Sciences opined, "This agreement is a win-win for both, as combined expertise, technologies, and innovation will be beneficial to both patients and doctors as well." ]]> https://biospectrumindia.com/news/97/22490/sai-life-sciences-opens-new-high-potency-api-manufacturing-facility-at-bidar.html https://biospectrumindia.com/news/97/22490/sai-life-sciences-opens-new-high-potency-api-manufacturing-facility-at-bidar.html Tue, 17 Jan 2023 00:00:00 +0530 Sai Life Sciences, Hyderabad-based Contract Research, Development & Manufacturing Organisation (CRO-CDMO), has announced the opening of a new High-Potency API (HPAPI) manufacturing facility at its cGMP API Manufacturing campus in Bidar, Karnataka. The addition of this new facility expands the company's expertise across HPAPI development and manufacturing, providing its customers with a streamlined pathway for new chemical entity (NCE) development. The new 16000 sq. ft. HPAPI block, located in the Bidar Manufacturing Campus of the company, is designed and validated to handle high potent molecules less than 1 μg/m3 containment; it has inbuilt warehouse to store key starting materials (KSMs), intermediates and finished goods; it has dedicated sampling / dispensing area with isolators with three independent streams to handle commercial scale batches. Earlier in 2022, the company had opened its HPAPI Development facility at its Hyderabad R&D campus. Now, with the addition of the new HPAPI production facility in Bidar, the company is capable of handling of all aspects of the project life cycle spanning process development, analytical development, particle engineering, warehousing, pilot, scale up, sampling, QC, powder processing, effluent treatment, packing, transportation and stability services. Over the past couple of years, the company has undergone an intense phase of transformation as part of its Sai Nxt initiative, executing investments of over $120 million in its capacity and operations, expanding into new geographies, growing its scientific talent base, and raising the overall bar for quality, compliance and performance. ]]> https://biospectrumindia.com/news/97/22465/sai-life-sciences-schrdinger-to-set-up-offshore-research-lab-in-hyderabad.html https://biospectrumindia.com/news/97/22465/sai-life-sciences-schrdinger-to-set-up-offshore-research-lab-in-hyderabad.html Tue, 10 Jan 2023 17:15:00 +0530 Sai Life Sciences, a Contract Research, Development & Manufacturing Organisation, has entered a five-year strategic agreement with Schrödinger, whose physics-based computational platform is transforming the way therapeutics and materials are discovered, to set up the SaiSchrödinger Research Laboratories (SSRL) in Hyderabad.   Being built inside Sai Life Sciences' R&D campus in Genome Valley, Hyderabad, SSRL will be a dedicated facility for integrated discovery work streams including medicinal and synthetic chemistry, in vitro biology, and process chemistry. It will access other Sai capabilities such as in vitro ADME and in vivo PK as needed. The relationship will support the advancement of programmes that leverage Schrödinger's validated computational platform.   Scheduled to open in April 2023, SSRL will commence with about 75 staff members, across full-time-equivalents (FTEs) in medicinal chemistry, biology, process chemistry, analytical chemistry and other support staff.  ]]> https://biospectrumindia.com/news/97/22263/animal-free-test-systems-key-for-navigating-toxicology-approach-in-india.html https://biospectrumindia.com/news/97/22263/animal-free-test-systems-key-for-navigating-toxicology-approach-in-india.html Fri, 18 Nov 2022 00:00:00 +0530 Clariant India,headquartered in Navi Mumbai, recently highlighted the need for ethical, data based and technologically led toxicological testing at its one day industry workshop titled, ‘Navigating headwinds in Regulatory Toxicology’. The event was being held in Mumbai with attendance several clinical research organisations (CROs) across industries. The industry event sought to support Indian CROs in their progress in the fast developing toxicology sector. The major themes that emerged from the discussion were alternative methodologies to animal testing, chemical strategies for sustainability - toxic free environment, and new approache methodologies (NAM) in toxicology in the challenging framework the Indian sector navigates through. The industry event saw Clariant global experts and various Indian industry leaders like Dr Nitin Shetty  of Bioneeds India, Dr Ganiger from Eurofins Advinus and Dr Mohmad Sadik A. Mulla from Vimta Labs among the speaker list. Speaking on the occasion Dr Fabian Grimm, Head of Toxicology and Ecotoxicology, Global Product Leadership Clariant said, “Today it is not chemical safety alone  being a pre-requisite for product compliance, marketability, customer satisfaction but it is safety and sustainability of our products. One of the major challenges is in creating a gradual shift towards animal-free test systems and approaches – collectively known as ‘New Approach Methods’ or NAMS. Through workshops like this, Clariant as a global leader, engages in multi stakeholder dialogues to actively contribute towards further development and implementation of such alternative approaches.” ]]> https://biospectrumindia.com/news/97/22180/us-based-cro-emmes-rapidly-expands-in-india-.html https://biospectrumindia.com/news/97/22180/us-based-cro-emmes-rapidly-expands-in-india-.html Thu, 27 Oct 2022 00:00:00 +0530 Emmes, a global, full-service Contract Research Organisation (CRO), has rapidly expanded its capabilities in India during the last two years. Emmes’ India operations are headquartered in Bengaluru with an additional office in Ahmedabad. The company’s operations in India have seen surging growth with local revenue increasing by 400% and global study revenue increasing by more than 50%. The CRO forecasts its Indian operations will grow further over the next year, with employee numbers quickly surpassing 200.  60%+ growth has been achieved over the past year with continued high growth planned over the next three years. Expertise in vaccines and infectious diseases are particular strengths. Emmes has an especially strong pedigree in vaccines and has completed several trials in India, Bangladesh and Africa – including tuberculosis, shigellosis, enterotoxigenic Escherichia coli (ETEC), polio, human papillomavirus (HPV), yellow Fever, respiratory syncytial virus (RSV), influenza, COVID-19 and typhoid. Exponential growth in the size of the local team and services offered has resulted in enhanced ability to support large Phase III and IV studies. And, in fact, the team in India is currently leading five Phase III trials for global clients. Looking ahead to 2023, the Emmes team in India has identified indigenously developed vaccine trials as a strong growth area, as well as a broad spectrum of trials from international sponsors. ]]> https://biospectrumindia.com/news/97/22156/aragen-life-sciences-opens-new-formulations-facility-at-hyderabad.html https://biospectrumindia.com/news/97/22156/aragen-life-sciences-opens-new-formulations-facility-at-hyderabad.html Sun, 23 Oct 2022 00:00:00 +0530 Aragen, a leading contract research development and manufacturing organization (CRDMO), has announced that it will operationalise its state-of-the-art formulation manufacturing facility in the Mallapur campus, Hyderabad, India by January 2023. The 12,000 square feet new facility will strengthen the company’s ability to deliver clinical supplies to customers through its integrated drug substance and drug product development and manufacturing. The new plant will include a wide range of dosage form capabilities for oral solids, liquids, topicals, films, and manufacturing technologies for granulation, film coating, spray drying, tableting – with expansion plans already in place to add nano milling and hot melt extrusion capabilities. These new capabilities at the Mallapur Campus will further enhance Aragen’s New Chemical Entity (NCE) early-stage development offerings, providing customers the convenience to discover and develop drugs from a co-located facility. It will provide greater flexibility to deliver customers’ clinical supply needs in multiple dosage forms, with process technologies and flexible batch sizes as low as 1000 units to as high as 100000 units.   ]]> https://biospectrumindia.com/news/97/22127/teleradiology-solutions-inaugurates-new-centre-at-andhra-med-tech-zone.html https://biospectrumindia.com/news/97/22127/teleradiology-solutions-inaugurates-new-centre-at-andhra-med-tech-zone.html Tue, 18 Oct 2022 05:25:00 +0530 Teleradiology Solutions (TRS), a leading global provider of remote radiology services, has inaugurated its new centre at Andhra Med Tech Zone (AMTZ). Through this hub, AMTZ and TRS will reach out to pan-India government hospitals, state-wide rural health centres (including those under the National Health Mission), and public sector undertakings with hospitals where TRS will provide remote radiology services. Teleradiology Solutions has always been at the forefront in innovatively using information technology to strengthen the healthcare sector of the country, contributing to the vision of the Government’s National Digital Health Mission (NDHM) and Ayushman Bharat Digital Mission (ABDM). The new centre at AMTZ will not only focus on reporting of radiologic images from all states of our country but will also set an example that will enable the national healthcare sector to adopt current-generation technologies. Dr Arjun Kalyanpur, CEO & Chief Radiologist, Teleradiology Solutions said, "70% of Indian population are from villages, and consequently, the majority is deprived of radiologist access since most of them reside in metros and larger cities. We are happy to open our new centre here at AMTZ to address this issue and deliver best-in-class radiology diagnostics to remote areas so that public sector and government hospitals can also enjoy the benefits of teleradiology, image storage and sharing and comprehensive reporting solutions. The hub will also generate employment opportunities for young Radiologists, Medical imaging technologists, Software Engineers, and other supporting staff.” Dr Jitendra Sharma, MD & CEO, AMTZ said, "We are striving to downsize the imports of medical devices in India and manufacture supplying medical equipment indigenously in the zone. AMTZ is known as the world's largest medical devices manufacturing park and we are happy to collaborate with TRS to boost the production of local MedTech products such as CT Scanner, and MRIs with fully integrated reporting, storage and analytical services in the locations where radiologists are unavailable."      ]]> https://biospectrumindia.com/news/97/22109/intuitive-india-unveils-first-of-its-kind-robotic-assisted-surgery-experience-centre.html https://biospectrumindia.com/news/97/22109/intuitive-india-unveils-first-of-its-kind-robotic-assisted-surgery-experience-centre.html Thu, 13 Oct 2022 13:00:00 +0530 Intuitive Surgical, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery (RAS), has unveiled a first of its kind initiative to familiarize healthcare professionals to robotic-assisted Surgery. The programme called ‘Xi experience centre’  was unveiled at the FICCI Heal conference in New Delhi. Intuitive India has set up this experience centre as a part of their commitment to enhance the surgical ecosystem in India. This programme aims to familiarise the medical fraternity with robotic-assisted surgery, its features, and clinical applications as robotic-assisted surgery has been more effective for soft-tissue surgeries, which require more precision. Commenting on the unveiling of Xi Experience centre, Mandeep Singh Kumar, VP & GM of Intuitive India, said, "Though there has been a continuous increase in the adoption of Robotic Assisted Surgery (RAS) in the recent past, there is a need for more surgeons to take up such tech advancements to cater to the ever-growing need." As a part of this initiative, Intuitive has formulated a comprehensive programme to ensure extensive hands-on learning for the surgeons. This centre is equipped with Intuitive’s latest Da Vinci Xi technology, and other state of the art facilities such as wet lab. This centre also demonstrates advanced technologies for real-time visual assistant, dual grip technology, and suturing & simulation exercises. Intuitive's robotic-assisted surgery simulator, SimNow is also used at the Xi Experience centre. Surgeons and residents can use SimNow to get familiar with the robotic-assisted procedures. ]]> https://biospectrumindia.com/news/97/22034/rakuten-medical-to-bring-innovative-cancer-treatment-technology-alluminox-to-india.html https://biospectrumindia.com/news/97/22034/rakuten-medical-to-bring-innovative-cancer-treatment-technology-alluminox-to-india.html Thu, 29 Sep 2022 02:00:00 +0530 Rakuten Medical, Inc. has recently established its subsidiary in India, Rakuten Medical Private Limited (Rakuten Medical India) to strengthen its position in the country and expand its presence worldwide. The Mumbai-based company plans to develop and commercialize treatments based on the Alluminox platform in India, beginning with head and neck cancer. To ensure a strong footprint, Mickey Mikitani, Co-CEO of Rakuten Medical recently visited leading medical institutions in the country to exchange views on the current status and future development of cancer treatment. Rakuten Medical’s proprietary technology platform Alluminox combines the power of light with drug, device, and other related components to develop new, innovative therapies. Illuminating the targeted cells with non-thermal light activates the cell-bound drug, which leads to rapid and selective cell killing. This therapy has potential to be a 5th pillar of cancer treatment. “Rakuten Medical’s technology has an unprecedented mechanism of action that selectively and precisely attacks targeted cells,” said Dr. Rajendra Achyut Badwe, Director and Head of Surgical Oncology at Tata Memorial Centre. “We will collect robust data to ascertain efficacy as well as effectiveness of this novel therapy in head and neck cancers.” Dr Devi Prasad Shetty, Founder and Chairman at Narayana Health said, “We are welcoming the pioneering technology of Rakuten Medical, which will potentially help people in India lead healthier lives, and happy to support Rakuten Medical in its mission to ‘Conquer cancer’.”     Image caption- (Left image)- Mickey, Dr Rajendra Badwe and Dr Pankaj Chaturvedi (from left) at Tata Memorial Centre; (Right image)- Mickey and Dr Devi Prasad Shetty (from left) at Narayana Health ]]> https://biospectrumindia.com/news/97/22004/c-camp-and-siemens-healthineers-join-forces-with-special-focus-on-diagnostics.html https://biospectrumindia.com/news/97/22004/c-camp-and-siemens-healthineers-join-forces-with-special-focus-on-diagnostics.html Fri, 23 Sep 2022 22:00:00 +0530 Centre for Cellular and Molecular Platforms (C-CAMP) and Siemens Healthineers have formed a partnership to explore synergies in innovation and entrepreneurship development in healthcare domain with specific focus on Diagnostics, a core strength of both partners. The agreement’s primary aim is to combine the technical expertise and scientific resources built by C-CAMP and Siemens Healthineers to enable common access to state-of-the-art diagnostics assays, clinical testing capacities, artificial intelligent (AI) technology, hardware and software automation solutions that align with local needs and local ecosystems.   The MoU was signed by C-CAMP CEO & Director, Dr Taslimarif Saiyed and Dileep Mangsuli, Executive Director, Siemens Healthineers at a ceremonial event held at C-CAMP on 23 September. The partnership formalized for a year, will focus on diagnostics in point-of-care, in vitro or laboratory testing, imaging & genomics, CRISPR-Cas testing etc. with possibilities in antibiotic susceptibility, antimicrobial resistance, onco-assays and biomarkers, and AI-based rapid triaging.   ]]> https://biospectrumindia.com/news/97/21993/national-small-industries-corporation-inks-mou-with-andhra-pradesh-medtech-zone.html https://biospectrumindia.com/news/97/21993/national-small-industries-corporation-inks-mou-with-andhra-pradesh-medtech-zone.html Thu, 22 Sep 2022 11:20:00 +0530 A Memorandum of Understanding (MoU) was recently signed between the National Small Industries Corporation (NSIC), a Public Sector Enterprise of the Ministry of MSME, Government of India and Andhra Pradesh Medtech Zone (AMTZ), on cooperation in the healthcare sector. BB Swain, Secretary (MSME) and other senior officers were present.   The MoU was signed by Gaurang Dixit, CMD, NSIC and Dr Jitendra Sharma, MD and CEO, AMTZ.    Union Minister for MSME Narayan Rane mentioned that the signing of this MoU between NSIC and AMTZ will be a significant step toward enhancing the competitiveness of MSMEs in the healthcare sector. He also stated that both organisations can leverage their expertise and create excellent opportunities for MSMEs in the healthcare sector to form global alliances and get access to the latest medical technologies along with creating skilled manpower for this sector.      ]]> https://biospectrumindia.com/news/97/21977/aragen-neovac-collaborate-to-manufacture-lipid-products-for-rna-vaccines.html https://biospectrumindia.com/news/97/21977/aragen-neovac-collaborate-to-manufacture-lipid-products-for-rna-vaccines.html Tue, 20 Sep 2022 12:35:00 +0530 Hyderabad-based Aragen Life Sciences has entered into an agreement with a UK-based company, NeoVac, for manufacturing a lipid product that will support the development of lipid nanoparticles (LNP) for use in developing RNA vaccines for various diseases.Aragen has been working with NeoVac since early December 2021 on process research development (PRD) for the lipid product.NeoVac is creating revolutionary and proprietary next-generation LNP to enable better RNA vaccines for various diseases. The LNPs are being developed using cutting-edge technology that makes RNA vaccines more thermostable and accessible with broader capabilities andfewer side effects.Announcing the collaboration, Dr Ramesh Subramanian, Chief Commercial Officer, Aragen, said, “Having been associated with the project at the development phase will enable a seamless transition to the manufacturing phase. This collaboration validates Aragen’s capabilities across discovery, development and manufacturing to support our customers develop products for the betterment of people across the globe.”Eran Eilat, CEO, NeoVac¸ added, “NeoVac is working on multiple RNA vaccine projects that aim to bring the next generation of this technology to millions around the world with outstanding unique qualities. Our partnership with Aragen during the development phase has been fruitful and we are happy to extend the collaboration into themanufacturing phase.” ]]> https://biospectrumindia.com/news/97/21967/fujifilm-india-launches-second-phase-of-tb-campaign.html https://biospectrumindia.com/news/97/21967/fujifilm-india-launches-second-phase-of-tb-campaign.html Mon, 19 Sep 2022 08:35:00 +0530 Fujifilm India has launched the second phase of its campaign on TB 'NEVER STOP: SCREENING TO REDUCE DIAGNOSTIC DELAYS.' The second phase of this campaign aims to increase awareness on tuberculosis (TB) as a curable disease and promote screening and early diagnosis among tea sector workers, difficult to reach the population in rural and urban areas including the tribal population in selected districts of Gujarat, Kerala and Assam. Under the campaign, Fujifilm India will support three mobile handheld X-ray machines and the implementation of the project in community settings.   Fujifilm aims to reach more than five million people and screen around 30,000 of them by using handheld X-ray machines. The project will also facilitate TB testing of identified presumptive cases. In association with International Union Against TB and Lung Disease (The Union), the project aims to demonstrate a model for promoting early diagnosis of TB by utilising newer solutions in community settings. Through the campaign, Fujifilm will be offering door-to-door awareness of TB and providing mobile digital X-ray services along with Qure.ai’s computed-aided radiology software application designed with deep-learning for the intervention.   The proposed districts in this phase are Sonitpur, Golaghat, Jorhat, Sivasagar, Dibrugarh, Tinsukia, in Assam, Wayanad in Kerala, and Kutch district in Gujarat starting September 2022 and conclude by August 2023.   ]]> https://biospectrumindia.com/news/97/21924/aragen-expands-collaboration-with-msd-.html https://biospectrumindia.com/news/97/21924/aragen-expands-collaboration-with-msd-.html Thu, 08 Sep 2022 10:20:00 +0530 Aragen Life Sciences (Aragen), a leading Contract Research and Development Organization (CRO), headquartered out of Hyderabad, has announced the expansion of its collaboration with MSD (tradename of Merck & Co, Rahway, NJ, USA) to provide discovery services and solutions supporting MSD’s global R&D efforts.“We look forward to continuing to work with MSD researchers to advance its pipeline of therapeutic candidates,” said Manni Kantipudi, CEO, Aragen. “At Aragen, our team believes that ‘in every molecule is the possibility for better health’. By treating every project with urgency and focus, we look to discover and develop medicines for our collaborators that make a positive impact on patients.” Dr Sudhir Kumar Singh, COO, Aragen, added, “Over the past several years, we have worked diligently at building a world-class scientific team, equipping them with state-of-the-art infrastructure, and inculcating a culture of customer-centricity.” ]]> https://biospectrumindia.com/news/97/21905/iit-guwahati-to-establish-centre-for-advanced-research-on-diagnostics-in-cancer.html https://biospectrumindia.com/news/97/21905/iit-guwahati-to-establish-centre-for-advanced-research-on-diagnostics-in-cancer.html Fri, 02 Sep 2022 14:45:00 +0530 Indian Institute of Technology (IIT) Guwahati has signed a Memorandum of Understanding (MoU) with Mumbai-based startup Karkinos Healthcare (KH) for research collaboration on cancer diagnostics. The MoU was signed between Prof TG Sitharam, Director, IIT Guwahati and R Venkataramanan, CEO, Karkinos Healthcare.   Under the agreement, a Centre of Advanced Research on Diagnostics in Cancer (C-CARD), a first-of-its-kind in the nation with an IIT, will be set up at IIT Guwahati. The centre will be equipped and operated by KH at the IIT Guwahati premises for its establishment. The primary aim of this centre is to work on research related to advanced and affordable diagnostics solutions for non-communicable diseases, primarily Cancer for patients from across the nation.   The MoU will collaborate on initiatives including:   Ø A large-scale OncoDiagnostic services in conjunction with Assam Cancer Care Hospitals across the state to prepare a comprehensive cancer atlas for North-East Ø Establishment of Next-Generation Sequencing (NGS) and Whole Genome Sequencing (WGS) facilities to identify the India-specific hereditary origin of this giant killer Ø Capability development on high-end data analytics using Artificial Intelligence (AI) and Machine Learning (ML) techniques Ø High-quality informatics for research and development through comprehensive genomic landscape identification Ø Capacity development through academic collaboration on clinical excellence Ø Partnerships with biotech and pharma majors     ]]> https://biospectrumindia.com/news/97/21893/bd-india-unveils-rapid-molecular-technique-to-detect-mdr-tb-infectious-diseases.html https://biospectrumindia.com/news/97/21893/bd-india-unveils-rapid-molecular-technique-to-detect-mdr-tb-infectious-diseases.html Thu, 01 Sep 2022 08:25:00 +0530 BD Diagnostics, a segment of BD Lifesciences, has introduced the BD MAX molecular diagnostic system and the availability of the BD MAX MDR-TB panel in India.   The MAX MDR-TB panel is included in WHO guidelines and now clinicians can use the test to simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain mutations associated with resistance to two important first-line drugs - Isoniazid (INH) and Rifampicin (RIF) respectively.   The molecular test enhances the information available to direct the optimal treatment for patients and rules out the need for a separate test for isoniazid (INH) detection.   The BD MAX System is a fully integrated, automated platform that performs nucleic acid extraction and real-time PCR thereby supporting clinicians in prompt and accurate patient disease diagnoses. The state-of-the-art BD MAX System also empowers laboratories to automate their unique internally developed molecular assays, while accessing a rich and growing menu of world-class assays.   ]]> https://biospectrumindia.com/news/97/21867/5c-network-launches-ai-powered-platform-prodigi-for-radiologists.html https://biospectrumindia.com/news/97/21867/5c-network-launches-ai-powered-platform-prodigi-for-radiologists.html Fri, 26 Aug 2022 15:00:00 +0530 5C Network has launched an artificial intelligence-powered platform called Prodigi. This state-of-the-art platform enables teleradiology at a massive scale and makes it possible for diagnostic centres and hospitals to submit scans and access reports directly on the cloud-based platform. Realising the growing dependence on radiology for diagnosis, monitoring, and prognosis, 5C Network believes that Prodigi will go a long way in reducing the burden on radiologists as well as referring doctors. The highly advanced platform compresses radiology scan images losslessly i.e. without compromising on image quality. The platform is easy to use and can be accessed using desktop as well as mobile devices.   The Prodigi platform is the core of 5CNetwork’s flagship teleradiology service called Borderless Radiology. Breaking geographical constraints, 5C offers radiologist interpretation of X-ray, CT, MRI, Mammogram, and Nuclear Medicine, sending the scanned images to the most suitable, qualified radiologist for the study. What is noteworthy is that by this remarkable innovation of Prodigi, 5C Network has brought massive scalability to the hitherto person-dependent teleradiology practice.   Using Prodigi, a hospital or diagnostic centre can upload a digital image on the platform seamlessly. The image is read by an AI, which in turn assigns it to radiologists, based on their experience and expertise. The radiologists can report on the platform directly and do annotations on the same as well. It also supports speech-to-text function when required in addition to providing standardised report templates that save a lot of time. The company aims for year-on-year growth of 50-100 per cent. ]]> https://biospectrumindia.com/news/97/21853/molbio-diagnostics-announces-largest-multi-country-roll-out-of-tb-test.html https://biospectrumindia.com/news/97/21853/molbio-diagnostics-announces-largest-multi-country-roll-out-of-tb-test.html Wed, 24 Aug 2022 18:20:00 +0530 After the successful domestic rollout of Goa-based Molbio Diagnostics' Truenat MTB by the National Tuberculosis Elimination Programme, a multi-country rollout has been initiated by the “introducing New Tools Project (iNTP)”, a collaboration between the Stop TB Partnership, the United States Agency for International Development (USAID) and United Nations Office for Project Services (UNOPS) in nine high TB burden countries in Asia and Africa.    The roll-out package enables uptake of WHO-endorsed innovation in diagnostics, treatment and digital health technologies to strengthen TB care in high-burden countries. The New Tools Project aims to improve access to rapid molecular testing through the introduction of Truenat as the initial diagnostic test in peripheral health facilities as a replacement for sputum smear microscopy as mandated by WHO.    The countries covered in the first phase are Nigeria, the Democratic Republic of Congo, Uganda, Kenya, Zimbabwe, Bangladesh, Cambodia, Vietnam and the Philippines. Truenat Installations are completed in Nigeria, Zimbabwe, Cambodia, DR Congo, Philippines, Uganda and Kenya while it's underway in Bangladesh and Vietnam.   Molbio Diagnostics' Truenat is a point-of-care platform endorsed by the World Health Organization (WHO) for rapid molecular detection of Tuberculosis and Rifampicin resistance. Truenat is a portable, battery-operated, IoT-enabled, point-of-care Real-Time PCR platform with a turn-around time of less than 1 hour that can be deployed even in resource-limited settings and remote areas. In addition to TB, the Truenat platform can test for over 35 other diseases. ]]> https://biospectrumindia.com/news/97/21826/erba-transasia-unveils-monkeypox-pcr-test-kit-.html https://biospectrumindia.com/news/97/21826/erba-transasia-unveils-monkeypox-pcr-test-kit-.html Sat, 20 Aug 2022 12:00:00 +0530 India's first MonkeyPox PCR test kit by Erba-Transasia was launched by Prof Ajay Kumar Sood, Principal Scientific Adviser to the Government of India. Dr Arabinda Mitra, Scientific Secretary, Office of the Principal Scientific Adviser to the Government of India, Prof Balram Bhargava, former Director-General at the Indian Council of Medical Research (ICMR), Dr Alka Sharma, Adviser in the Department of Biotechnology and Dr Jitendra Sharma, MD & CEO, Andhra Pradesh Medtech Zone (AMTZ) at a brief launch ceremony at  Andhra Pradesh MedTech Zone (AMTZ), Vizag.Transasia-Erba Monkeypox RT-PCR Kit is a highly sensitive but easy-to-use RT-PCR assay with a uniquely formulated primer and probe for enhanced accuracy.Dr Manoj Chugh, Vice President, R&D Reagents, Transasia Bio-Medicals further added, “The ErbaMDx Monkey Pox RT PCR kit is compatible with commonly available RT PCR analysers and extraction platforms. This kit further ensures zero cross-reactivity from other orthopox viruses or organisms.”Transasia Diagnostic's technologically advanced world-class IVD production facility at AMTZ can manufacture more than 200 million tests/month for Monkey Pox alone. ]]> https://biospectrumindia.com/news/97/21811/molbio-diagnostics-truenat-rt-pcr-test-for-hiv-1-hiv-2-to-give-results-in-1-hour.html https://biospectrumindia.com/news/97/21811/molbio-diagnostics-truenat-rt-pcr-test-for-hiv-1-hiv-2-to-give-results-in-1-hour.html Wed, 17 Aug 2022 17:10:00 +0530 Goa-based Molbio Diagnostics has launched a new test for differential diagnosis of HIV 1 and HIV 2 with viral loads within 60 minutes. The test works on the existing Truelab infrastructure and will require no additional set-ups and equipment.Truenat is a point-of-care portable, battery-operated, IoT-enabled, Real Time PCR platform with a sample-to-result time of less than one hour. The platform can test over 35 diseases, including COVID-19, TB, Hepatitis, HIV, HPV, dengue, malaria, etc.Sriram Natarajan, CEO, Founder and Director, Molbio Diagnostics, said, “Being a point of care platform Truenat HIV 1/ HIV 2 will provide universal access to both early detection and viral load estimation."Dr Chandrasekhar Nair, CTO and Director, Molbio Diagnostics, said, "Truenat HIV1/HIV2 can provide test results in an hour, assuring early and accurate diagnosis of the infection." ]]> https://biospectrumindia.com/news/97/21803/wipro-ge-healthcare-boston-scientific-to-advance-cardiac-care-in-india.html https://biospectrumindia.com/news/97/21803/wipro-ge-healthcare-boston-scientific-to-advance-cardiac-care-in-india.html Tue, 16 Aug 2022 15:00:00 +0530 GE Healthcare has announced its collaboration with Boston Scientific to provide end-to-end innovative interventional cardiac care solutions in India. The collaboration will enable easier access to treatment and is intended to improve heart care for patients, thereby addressing the disease burden prevailing in the country.This is a first-of-its-kind collaboration between the two MedTech companies in India, both with strong interventional cardiology portfolios. The advanced medical devices and capabilities from Boston Scientific, coupled with GE Healthcare’s strong medical imaging systems like cardiac catheterisation lab and related software, support diagnostics through treatment and monitoring of the cardiac patient-care pathway. The companies will work to collectively support the training and education of healthcare professionals and raise consumer awareness about the impact of vascular imaging advancements within cardiac catherization procedures, thus enabling better patient outcomes. Earlier this year, GE Healthcare signed a similar partnership with Boston Scientific in Southeast Asia which also offers combined cardiology solutions to customers including in training and education. ]]> https://biospectrumindia.com/news/97/21799/redcliffe-labs-launches-gene-to-the-gene.html https://biospectrumindia.com/news/97/21799/redcliffe-labs-launches-gene-to-the-gene.html Mon, 15 Aug 2022 17:05:00 +0530 Redcliffe Labs has launched GENEë-To the Gene, a common platform for all genetic needs of doctors and patients. The launch also marked the inauguration of North India’s first-of- its-kind and most advanced genetics laboratory by Redcliffe Genetics (the specialised wing of Redcliffe Labs) in Noida, Uttar Pradesh.    GENEë is a platform consisting of a team of DM Geneticists from across India and senior board-certified counsellors. The platform will help bridge the gap between clinicians from every part of India and clinical geneticists for guidance on testing and training on genetics. For report guidance and support, GENEë will bring patients closer to a certified geneticist and a genetic counsellor. Geneticists shall be connected to clinicians to also conduct online and offline clinics pan India, a first-of-its-kind initiative.   The other advantages of this platform include technical guidance by certified counsellors and geneticists with a technical team of clinicians. Furthermore, geneticists on the platform will also do online training with government and private institutes on the fundamentals of genetics and genetic testing. Besides, it will create possibilities for geneticists from India to join the platform to support correct genetic testing for patients. ]]> https://biospectrumindia.com/news/97/21722/mylab-unveils-advanced-innovation-centre-for-diagnostics.html https://biospectrumindia.com/news/97/21722/mylab-unveils-advanced-innovation-centre-for-diagnostics.html Thu, 28 Jul 2022 16:35:00 +0530 Pune-based startup Mylab Discovery Solutions has announced the opening of India’s most advanced Innovation Centre for diagnostics in Pune. ‘Mylab Global Innovation Centre’ was inaugurated by Dr Cyrus S Poonawalla, CMD, Serum Institute of India.   The centre will develop and commercialise pioneering diagnostic innovations in diverse fields including molecular, serology, immunology, automation, robotics, AI-based diagnostic solutions, devices and biosensors. This futuristic centre aims to drive cutting-edge research and advance impactful solutions to address healthcare challenges for Indian and international markets.    Spread over 42,000 square feet, the centre will be equipped with state-of-the-art equipment and comprehensive research capabilities that enable research scientists and engineers to bring ideas to life. It will have over a 450-strong employee base – 70 per cent of whom are research scientists, with a dynamic work environment.      Image caption- From L to R - Shailendra Kawade, Chairman of Mylab, Hasmukh Rawal, MD of Mylab, Dr. Cyrus Poonawalla, - Chairman and Managing Director of Serum Institute of India, Cyrus Poonawalla Jr.(Adar’s son), Adar Poonawalla - CEO, Serum Institute of India, Sujit Jain - Director Strategy, Mylab and Abhijit Pawar - Founder & Chairman of AP Globale & DCF and MD Sakal Media Group ]]> https://biospectrumindia.com/news/97/21700/genes2me-unveils-rt-pcr-based-kit-for-monkeypox-virus-detection.html https://biospectrumindia.com/news/97/21700/genes2me-unveils-rt-pcr-based-kit-for-monkeypox-virus-detection.html Tue, 26 Jul 2022 15:30:00 +0530 Gurugram-based Genes2Me has developed the Real-Time PCR-based kit for quick detection of Monkeypox virus with a fast turnaround result time of less than 50 minutes.   This kit is available in both the standard version for any commonly available Real-Time PCR instruments as well as Point-of-Care format on Genes2Me Rapi-Q HT Rapid RT-PCR device.    Scientists from Genes2Me have been able to develop 'POX-Q Multiplexed RT-PCR kit' for the detection of Monkeypox virus along with differentiation from Varicella Zoster Virus (Chicken Pox) in a single tube multiplex reaction format. First, of its kind `Made in India' product, this kit is available as Research-Use only (RUO) and based on the Gold standard Taqman chemistry-based RT PCR method.     ]]> https://biospectrumindia.com/news/97/21680/ncisms-advanced-automated-system-for-therapeutic-emesis-bags-patent.html https://biospectrumindia.com/news/97/21680/ncisms-advanced-automated-system-for-therapeutic-emesis-bags-patent.html Fri, 22 Jul 2022 10:30:00 +0530 An advanced automated system or instrument for Therapeutic Emesis has been developed, which will make this therapy simple and convenient. The product has been developed by Dr APJ Abdul Kalam Ayurtech Incubation Centre of KLE Ayurworld and KLE Engineering College at Belagavi, Karnataka. The technology was amongst Top 10 at IICDC 2018 and Incubate at NSRCEL, IIM Bangalore and supported by DST and Texas Instruments.   Dr B Sreenivasa Prasad, President, Board of Ayurveda, National Commission for Indian System of Medicine (NCISM) and his team of inventors were granted a patent for the development of an advanced automated system or instrument for Therapeutic Emesis by the Controller of Patents, Government of India.    The present patented equipment 'Advanced Automated Equipment or System for Therapeutic Emesis' has been developed to administer the difficult Vamana procedure comfortably. This technology is equipped with monitors for monitoring of vital data of patients during the procedure. There is a provision for handling vomitus hygienically and as per biomedical waste management policy. It is also provided with an emergency kit that is required to manage complications of the procedure. Clinical parameters that are required to assess the procedure are also automated.    The product has been developed by Dr APJ Abdul Kalam Ayurtech Incubation Centre of KLE Ayurworld and KLE Engineering college at Belagavi, Karnataka. The Technology was amongst Top 10 at IICDC 2018 and Incubate at NSRCEL, IIM Bangalore and supported by DST and Texas Instruments.   This advanced automated system will help the Ayurveda fraternity in teaching and practicing Ayurveda with the use of technology.  ]]> https://biospectrumindia.com/news/97/21675/fujifilm-opens-nura-health-screening-centre-in-gurugram.html https://biospectrumindia.com/news/97/21675/fujifilm-opens-nura-health-screening-centre-in-gurugram.html Thu, 21 Jul 2022 15:50:00 +0530 Fujifilm Corporation has launched a 'NURA' health screening centre focusing on cancer and lifestyle diseases screening in Gurugram. The second centre will open in Mumbai in September this year.   With the addition of two sites in Gurugram and Mumbai, Fujifilm will offer screening for cancer and lifestyle diseases in a total of three NURA sites. The company will continue to establish new NURA sites to further expand its health screening service business in emerging countries.       The NURA centre is equipped with Fujifilm’s various medical devices including a CT scan and mammography system, as well as an AI-based medical IT system that provides interpretation assistance to doctors, offering Japanese-style high-quality health screening services to residents and employees of nearby companies / medical facilities. People of various age groups have experienced the screening service and are satisfied with the services    Located at DLF phase 5, sector 43, Gurugram, ‘NURA’ health screening centre will tap into insight gained through health screening services. ]]> https://biospectrumindia.com/news/97/21659/lupin-diagnostics-opens-reference-lab-in-ranchi.html https://biospectrumindia.com/news/97/21659/lupin-diagnostics-opens-reference-lab-in-ranchi.html Tue, 19 Jul 2022 15:20:00 +0530 Lupin Diagnostics has launched its first Reference Laboratory in Ranchi. The new Reference Laboratory at Ranchi is equipped to conduct a broad spectrum of routine and specialised tests in the fields of molecular diagnostics, cytogenetics, flow cytometry, histopathology, cytology, microbiology, serology, haematology, immunology, and routine biochemistry.   People in Jharkhand can now avail preventive health check-ups, home collection and testing centres at 10 locations.   ]]> https://biospectrumindia.com/news/97/21643/holborn-wells-india-develops-monkeypox-rt-pcr-detection-kit.html https://biospectrumindia.com/news/97/21643/holborn-wells-india-develops-monkeypox-rt-pcr-detection-kit.html Fri, 15 Jul 2022 17:00:00 +0530 Holborn Wells India has developed a real-time PCR kit for the detection of the monkeypox virus (MPXV) in response to the recent spread of the virus in various countries. The test has been developed in coordination with Holborn Wells, UK.   Holborn Wells Monkeypox Real-Time PCR detection kit can detect the virus with high sensitivity and produces results within 90 minutes.   Over the last few weeks, multiple clusters of the monkeypox virus have been reported across the world. Early diagnosis using such assays are important to assist scientists and monitor such emerging infectious disease threats.   ]]> https://biospectrumindia.com/news/97/21628/medgenome-labs-launches-clonoseq-assay-in-india.html https://biospectrumindia.com/news/97/21628/medgenome-labs-launches-clonoseq-assay-in-india.html Thu, 14 Jul 2022 14:35:00 +0530 Bengaluru-based MedGenome is offering Adaptive Biotechnologies’ next-generation sequencing (NGS)-based clonoSEQ Assay to assess minimal residual disease (MRD) in patients with multiple myeloma (MM), chronic lymphocytic leukaemia (CLL) and B-cell acute lymphoblastic leukaemia (B-ALL).     The clonoSEQ test may effectively detect and monitor MRD in patients with certain types of blood cancer. It helps to detect MRD even at low levels offering a prognostic value to clinicians, helping them to assess how patients respond to treatment or if any change in disease management is required.   The test determines MRD at very low levels (10-6 sensitivity) as compared to other currently available assays for MRD detection and therefore imparts a benefit to a larger number of patients. The test identifies dominant immune cell clones at the time of high disease burden that can be monitored after the treatment to determine MRD.   ]]> https://biospectrumindia.com/news/97/21608/srl-diagnostics-launches-fatty-liver-index.html https://biospectrumindia.com/news/97/21608/srl-diagnostics-launches-fatty-liver-index.html Tue, 12 Jul 2022 16:05:00 +0530 SRL Diagnostics has launched of ‘Fatty Liver Index’, a first-line diagnostic test for non-alcoholic fatty liver disease.   Fatty Liver Index (FLI) is an algorithm-based index that includes multiple parameters; results of the GGT test (gamma-glutamyl-transferase), triglycerides test (TG), weight, height, body mass index (BMI) and waist circumference for the prediction of non-alcoholic fatty liver disease (NAFLD).    Anand. K, Chief Executive Officer, SRL Diagnostics said, “Epidemiological studies suggest prevalence of NAFLD is around 9% to 32% of general population in India with higher prevalence in those who are overweight or obese and those with diabetes or pre-diabetes. Additionally NAFLD has also emerged as one of the leading causes of cirrhosis, hepatocellular carcinoma and liver transplant in India. India is the first country to have added NAFLD to one of its national disease control programs by integrating it into the National Program on Prevention and Control of Cancer, Diabetes, Cardiovascular disease and Stroke by the Ministry of Health and Family Welfare. Precise diagnosis is the first step in disease control and we are proud to lead this initiative for NAFLD.”     ]]> https://biospectrumindia.com/news/97/21596/genestrings-opens-labs-in-delhi-ncr-and-lucknow.html https://biospectrumindia.com/news/97/21596/genestrings-opens-labs-in-delhi-ncr-and-lucknow.html Sat, 09 Jul 2022 15:10:00 +0530 Genestrings has inaugurated its satellite pathology labs at the Delhi Airport. The brand simultaneously launched nine other satellite pathology Labs across Delhi-NCR and one in Lucknow. The labs have been developed adhering to international standards of medical infrastructure and facilities and aim for the best diagnostic solutions by providing holistic solutions for routine pathology, advanced genetics and preventive healthcare. Out of these 10 satellite labs, the national reference lab is set up at Malviya Nagar. The 24/7 pathology lab at the Metro Building of Indira Gandhi International Airport at Terminal 3 will remain accessible for all the employees of the Delhi airport as well as the people of nearby localities in Gurgaon and Delhi.  ]]> https://biospectrumindia.com/news/97/21589/metropolis-healthcare-unveils-innovation-cell.html https://biospectrumindia.com/news/97/21589/metropolis-healthcare-unveils-innovation-cell.html Thu, 07 Jul 2022 21:00:00 +0530 Metropolis Healthcare has announced the launch of Metropolis Innovation Cell focusing on molecular genomics, super speciality pathology and companion diagnostics.   Under Innovation Cell, Metropolis is introducing various specialised tests related to pregnancy, cancer, infectious diseases and transplant management.   The company has introduced specialised tests for non-invasive genetic assessments for pregnancy management that can aid in the early detection of chromosomal abnormalities.   It has also launched BRCA1/BRCA 2 Genetic testing for Hereditary Breast and Ovarian Cancer (HBOC), and the molecular oncology pipeline for Lung and common cancers.   ]]> https://biospectrumindia.com/news/97/21574/tcg-lifesciences-opens-rd-facility-in-pune.html https://biospectrumindia.com/news/97/21574/tcg-lifesciences-opens-rd-facility-in-pune.html Wed, 06 Jul 2022 11:05:00 +0530 TCG Lifesciences (TCGLS), a global contract research organisation (CRO) and CDMO company with operations in Kolkata, Hyderabad, Richmond, VA, and Princeton, NJ, has opened a new R&D facility in Pune, as part of a major expansion.Pune with its proximity to Mumbai and Gujarat offers a great ecosystem of talents, scientific institutions, and relevant industry players which TCGLS plans to leverage to build a major presence there. It is taking up approximately 100,000 sq ft of space to build a comprehensive discovery services centre. Starting with an efficient team of chemists and support personnel in July 2022, TCGLS foresees the ability to accommodate a sizeable batch of chemists, biologists, and formulation scientists in the coming years. It is also looking at opportunities in speciality chemicals and polymer sciences activities in line with its parent company, The Chatterjee Group's investments in those domains. The labs are equipped with automation devices, safety instrumentation, and regular and walk-in fume hoods. It is supported by general access to scientific journals/databases, IT systems with secured networks, human resource officers, and best practices in safety and supply chain. ]]> https://biospectrumindia.com/news/97/21563/iit-d-unveils-one-stop-medical-technology-development-facility.html https://biospectrumindia.com/news/97/21563/iit-d-unveils-one-stop-medical-technology-development-facility.html Tue, 05 Jul 2022 00:00:00 +0530 The Indian Council of Medical Research (ICMR) and the Department of Health Research (DHR) have formally unveiled Medtech Product Ignition and Acceleration Gateway of India (mPRAGATI), a National Center for medical technology development under the ICMR-Medical Device and Diagnostics Mission Secretariat at the Indian Institute of Technology, Delhi (IIT-D).  mPRAGATI, which is sponsored by the ICMR and the DHR under PM-Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), will serve as an ISO certified, C-GMP compliant medical device manufacturing and testing facility to translate medical products from TRL 3 (proof-of-concept) to TRL 7 (ready for clinical evaluation). The facility is currently developing technologies for disease diagnosis, implantable devices for orthopeadic, ocular and cardiac needs. In addition to its formal activities, the facility will also conduct periodic boot camps, manpower training sessions for students, faculty and start-ups to foster the medical device development ecosystem. The facility will bring in technical consultants to fine tune designs and products to keep them at par with industry standard. This new initiative will bring about a major change in the biomedical ecosystem and help researchers, doctors, entrepreneurs, and academicians across India to effectively take their idea to market. Moreover, it will create a pipeline of advanced technologies and products in line with PM-ABHIM initiatives and will be monitored by the NITI Aayog. ]]> https://biospectrumindia.com/news/97/21471/apollo-cancer-centre-datar-cancer-genetics-launch-blood-test-for-breast-cancer-.html https://biospectrumindia.com/news/97/21471/apollo-cancer-centre-datar-cancer-genetics-launch-blood-test-for-breast-cancer-.html Wed, 22 Jun 2022 17:05:00 +0530 Apollo Cancer Centres in association with Datar Cancer Genetics has launched a blood test that can detect breast cancers at early stages in asymptomatic individuals. With an easy draw of a small quantity of blood, now, EasyCheck- Breast can help in the detection of breast cancer even before the first stage. The EasyCheck is available across India at all Apollo Cancer Centres.   Rajan Datar, Founder & Chairman, Datar Cancer Genetics, said, “Unfortunately, most cancers are detected at advanced stages which necessitate more intensive and expensive treatments which have a greater risk of debilitating side effects and treatment failures. EasyCheck- Breast is the culmination of years of collaborative international research and innovation and has been developed, tested, and validated on population-sized cohorts. A simple blood draw holds the promise of early cancer detection in asymptomatic individuals and opens the possibilities of successful treatments and improved survival.” ]]> https://biospectrumindia.com/news/97/21442/lupin-diagnostics-opens-regional-reference-lab-in-patna.html https://biospectrumindia.com/news/97/21442/lupin-diagnostics-opens-regional-reference-lab-in-patna.html Wed, 15 Jun 2022 16:15:00 +0530 Lupin has launched its first Regional Reference Laboratory in Patna, Bihar. The new Regional Reference Laboratory at Patna has capabilities to conduct a broad spectrum of routine and specialised tests in the fields of molecular diagnostics, cytology, microbiology, serology, haematology, immunology and routine biochemistry.   By establishing a presence in Patna, the company now looks forward to making a deeper foray into Bihar. Earlier this year, Lupin Diagnostics opened its Regional Reference Laboratories in Assam and West Bengal.   Through upcoming launches of laboratories in Jharkhand (Ranchi) and Orissa (Bhubaneshwar), the company is poised to solidify its position in east India.   The company started its journey by establishing a state-of-the-art 45,000 square foot National Reference Laboratory in Navi Mumbai with world-class equipment, experienced doctors assisted by trained technologists, and stringent quality control protocols. ]]> https://biospectrumindia.com/news/97/21431/medical-expo-india-2022-to-be-held-in-kolkata-from-june-24-26.html https://biospectrumindia.com/news/97/21431/medical-expo-india-2022-to-be-held-in-kolkata-from-june-24-26.html Tue, 14 Jun 2022 16:10:00 +0530 Swastik Projects is organising the 8th Medical Expo India (Kolkata) 2022 from June 24 to June 26 at Biswa Bangla Convention Center, Newtown, Kolkata to facilitate thousands of hospitals, clinics and the manufacturers of medical equipment, diagnostic equipment and lab devices and those who are into emerging technologies for the healthcare industry.   Medical Expo India will bring suppliers of medical equipment, diagnostic equipment and lab devices, accessories and healthcare services under one roof.   The three-day B2B exhibition and conference offers an exclusive opportunity for manufacturers, suppliers, distributors and service providers to showcase their latest products and innovations, develop their business and distribution network, and expand into new markets. The expo will help the exhibitors to gauge instant market reactions and feedback of end-users on their latest products and services too.       ]]> https://biospectrumindia.com/news/97/21426/healthians-unveils-live-reporting-of-diagnostic-tests.html https://biospectrumindia.com/news/97/21426/healthians-unveils-live-reporting-of-diagnostic-tests.html Mon, 13 Jun 2022 17:15:00 +0530 Healthians has announced diagnostic tests live reporting that starts just four hours after sample collection. With this launch, Healthians has become the first company in the diagnostic sector to offer such a feature to its users. The service has been launched in 10 cities in India, namely Delhi, Gurgaon, Noida, Mumbai, Bengaluru, Ahmedabad, Hyderabad, Ghaziabad, Faridabad, and Greater Noida. Under the service, Healthians users can see live updates on the reports for individual tests that they may have booked from the company. ]]> https://biospectrumindia.com/news/97/21420/genes2me-launches-covieasy-at-home-self-test.html https://biospectrumindia.com/news/97/21420/genes2me-launches-covieasy-at-home-self-test.html Mon, 13 Jun 2022 11:45:00 +0530 Gurugram-based Genes2Me has launched CoviEasy Self-Test Rapid Antigen test kit for COVID-19 that gives results in 10 minutes. Backed by an AI-driven mobile app, the IVD product delivers a high level of sensitivity and concordance of more than 98 per cent accuracy.    CoviEasy has undergone stringent quality checks at ICMR approved validation centre and further received approval from CDSCO India. CoviEasy test can be easily performed by following simple instructions provided on the mobile app leading to automated reporting of test results from this mobile app itself.   The CoviEasy test involves couple of easy and simple steps as is conducted with a nasal swab sampling, wherein the swab first need to be inserted in the nostrils. The swab needs to be dipped in the buffer tube and swirl 8-10 times in the extraction buffer. The Buffer is then dropped onto the CoviEeasy test device which shows test result as either positive or negative. The test device also comes with a unique QR code for unique patient data entry and accurate report generation.  ]]> https://biospectrumindia.com/news/97/21417/karkinos-healthcare-launches-centre-for-cancer-diagnostics-research-in-kochi.html https://biospectrumindia.com/news/97/21417/karkinos-healthcare-launches-centre-for-cancer-diagnostics-research-in-kochi.html Sun, 12 Jun 2022 22:05:00 +0530 Karkinos Healthcare has launched an advanced centre for cancer diagnostics and research in Kochi. The centre was inaugurated by  Chief Minister of Kerala, Pinarayi Vijayan.The centre will serve as a central lab for the Karkinos’ global oncology network, analysing specimens at the molecular and genomic level to aid in personalised targeted therapy, predicting possible responses to treatment as well as evaluating response by liquid biopsy. Karkinos Healthcare has installed the most advanced high-throughput HPV assay equipment Cobas 6800 in this centre with the ability to test over 1200 Human Papilloma Virus (HPV) assays of all high-risk types. Karkinos healthcare has partnered with professional organisations such as the Kerala Federation of Obstetrics and Gynaecologic (KFOG) to support the World Health Organisation’s mission of eliminating cervical cancer by 2030.In Kerala, Karkinos has established 11 units in existing multispecialty hospitals and planning to add 63 more centres by FY23. ]]> https://biospectrumindia.com/news/97/21408/redcliffe-labs-introduces-novaseq-6000-sequencing-system-to-its-diagnostic-tech-portfolio.html https://biospectrumindia.com/news/97/21408/redcliffe-labs-introduces-novaseq-6000-sequencing-system-to-its-diagnostic-tech-portfolio.html Fri, 10 Jun 2022 11:15:00 +0530 Redcliffe Labs has announced the addition of ‘NovaSeq 6000’ sequencing system to its diagnostic technology portfolio at its Noida National Reference Lab.   Ease of access to NovaSeq 6000 sequencing system will prove to be very useful, as currently there's no mass level testing protocol rolled out by the states for genetic diseases. Following the successful adoption of NovaSeq 6000 technology, high throughput speed and flexibility will be available to conduct research or tests that need the processing of massive amounts of data more efficiently and cost-effectively.    Moreover, the sophisticated sequencing system will allow healthcare to move closer to preventive precision medicine which will benefit everyone.   ]]> https://biospectrumindia.com/news/97/21403/first-ai-based-cataract-screening-solution-launches-in-india.html https://biospectrumindia.com/news/97/21403/first-ai-based-cataract-screening-solution-launches-in-india.html Thu, 09 Jun 2022 18:00:00 +0530 Sharp Sight Eye Hospitals in collaboration with Logy.AI envisions has introduced AI-based screening solution to identify cataracts on the spot with 92 per cent accuracy.   This is the first time just the smartphone has been used for cataract screening leveraging artificial intelligence (AI). It is set up with the aim to build cutting-edge AI products in the healthcare domain and bridge the gap between clinical medicine and technology by training healthcare professionals in AI.   Meanwhile, the AI-based screening solution is present as a simple chatbot on WhatsApp, so that it can be used for mass screening. It wouldn’t require anyone to download any separate application as only WhatsApp is required on the phone. Also, the solution works with very low internet connectivity in rural areas.   ]]> https://biospectrumindia.com/news/97/21401/mylab-unveils-at-home-pregnancy-test-kit-pregascreen.html https://biospectrumindia.com/news/97/21401/mylab-unveils-at-home-pregnancy-test-kit-pregascreen.html Thu, 09 Jun 2022 17:45:00 +0530 Pune-based Mylab Discovery Solutions has launched PregaScreen, an at-home pregnancy test kit that allows women to detect their pregnancy status themselves. With the launch of this test kit, the company marks its foray into the female healthcare segment. It plans to launch a range of products in this category in the coming months. Priced at Rs 55, PregaScreen offers a comfortable, easy-to-use and reliable test method for women to confirm their pregnancy after they have missed their first period. This at-home rapid test kit provides highly accurate results within just a few minutes with 99.99 per cent accuracy and can be purchased over-the-counter from local pharmacies across India. Each kit comprises a pregnancy stick device and a dropper. ]]> https://biospectrumindia.com/news/97/21385/strykers-global-technology-centre-opens-in-gurugram.html https://biospectrumindia.com/news/97/21385/strykers-global-technology-centre-opens-in-gurugram.html Tue, 07 Jun 2022 16:45:00 +0530 Medical tech company Stryker has opened a new research and development facility, Stryker’s Global Technology Centre (SGTC), at the International Tech Park, Gurugram. The 150,000 sq ft facility will help accelerate innovation in India and globally, and further support the company’s mission to make healthcare better. The centre is designed to connect with healthcare professionals and develop new technologies to meet their needs. Customers can access a range of Stryker’s products and learn more about the engineering behind the company’s life-changing technologies and innovations. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. ]]> https://biospectrumindia.com/news/97/21377/neuberg-diagnostics-with-abha-laboratory-opens-centre-in-surat.html https://biospectrumindia.com/news/97/21377/neuberg-diagnostics-with-abha-laboratory-opens-centre-in-surat.html Mon, 06 Jun 2022 16:55:00 +0530 Neuberg Diagnostics and Surat-based Abha Laboratory have formed a joint venture (JV) and inaugurated a state-of-the-art central Laboratory in Surat. The new company will be called Neuberg Abha Clinical Laboratories.   The lab is equipped to conduct and process about 2500-3000 samples in a day and deliver results within the given turnaround time which differs from test to test while maintaining the best-in-class quality. The state-of-the-art lab plans to open 15-20 collection centres within the next six months across Surat and South Gujarat.    The lab will also focus on specialised testing needs for hospitals, nursing homes, and smaller laboratories across South Gujarat. Additionally, Neuberg as a group is equipped to conduct futuristic tests such as genomics, proteomics, metabolomics, molecular biology, and digital pathology.         ]]> https://biospectrumindia.com/news/97/21356/medtronic-launches-fourth-generation-flow-diverter-to-treat-brain-aneurysms.html https://biospectrumindia.com/news/97/21356/medtronic-launches-fourth-generation-flow-diverter-to-treat-brain-aneurysms.html Wed, 01 Jun 2022 15:50:00 +0530 India Medtronic has launched CE marked fourth-generation flow diverter, Pipeline Vantage with Shield Technology for endovascular treatment of brain aneurysms. Pipeline Vantage with Shield Technology is a new flow diverter with enhanced design features for both the delivery system and implant. These features allow physicians to deliver, deploy and treat brain aneurysms and intracranial aneurysms with greater ease and reliability while providing a scaffold that promotes the growth of cells in the inner lining of the target blood vessel. Medtronic is also introducing a first-of-its-kind warranty programme called the PED Warranty Program. Through the warranty programme, patients treated with Medtronic’s Pipeline Embolization Device (Pipeline Flex Embolization Device with Shield Technology/ Pipeline™ Vantage with Shield Technology) will receive warranty coverage. ]]> https://biospectrumindia.com/news/97/21355/sarvodaya-healthcare-transcell-oncologics-partner-to-offer-predictive-genetic-analysis.html https://biospectrumindia.com/news/97/21355/sarvodaya-healthcare-transcell-oncologics-partner-to-offer-predictive-genetic-analysis.html Wed, 01 Jun 2022 13:15:00 +0530 Sarvodaya Hospital, Faridabad and Transcell Oncologics, a stem cell technology-based biotech company in Hyderabad, have announced that HEMATO PREGEN, a comprehensive test providing predictive health signature analysis services from Transcell will now be available at Sarvodaya Medicentre at GK Enclave 1 in New Delhi. HEMATO PREGEN provides analysis of 20,000+ genes, which are known as predictive biomarkers, covering 90 per cent of diseases resulting from gene anomalies. The test is based on Next Generation/Whole Exome Sequencing (NGS/WES) and assessment by GenePoweRx, a homegrown trained Bioinformatics Engine with AI & ML tools and endorsed by Memorial Sloan Kettering Cancer Center, USA, in line with the Broad Institute’s human genome project. The report takes up to 45 days and a post-counselling session is offered at the clinic thereafter. ]]> https://biospectrumindia.com/news/97/21327/trivitron-healthcare-launches-rtpcr-based-kit-for-monkeypox-virus.html https://biospectrumindia.com/news/97/21327/trivitron-healthcare-launches-rtpcr-based-kit-for-monkeypox-virus.html Fri, 27 May 2022 18:25:00 +0530 Trivitron Healthcare has developed the Real-Time PCR-based kit for the detection of monkeypox (Orthopoxvirus) virus.   The kit is four-colour fluorescence-based, which can differentiate between smallpox and Monkeypox in a one-tube single reaction format, with a total turnaround time of one hour.    In this four-gene RT-PCR kit, the first target detects the viruses in the wider orthopox group, the second and third targets detect and differentiate the monkeypox and smallpox virus respectively and the fourth target detects the internal control corresponding to human cell to address the assay performance and aid in following its epidemic spread.   This kit is available as Research-Use only (RUO) and based on literature search and in-silico design. ]]> https://biospectrumindia.com/news/97/21325/roche-develops-unique-pcr-tests-to-detect-monkeypox-virus.html https://biospectrumindia.com/news/97/21325/roche-develops-unique-pcr-tests-to-detect-monkeypox-virus.html Fri, 27 May 2022 00:00:00 +0530 Roche and its subsidiary TIB Molbiol have developed three unique LightMix Modular Virus kits in response to recent monkeypox virus concerns. Multiple clusters of the monkeypox virus have been reported within the past two weeks in several European countries and North America, which are regions where the virus is not normally found. “Roche has very quickly developed a new suite of tests that detect the monkeypox virus and aid in following its epidemiologic spread,” said Thomas Schinecker, CEO Roche Diagnostics. “Diagnostic tools are crucial for responding to and ultimately controlling emerging public health challenges as they advance response measures such as tracing efforts and treatment strategies.” The first LightMix Modular Virus kit detects orthopoxviruses, including all monkeypox viruses from both the West African and Central African forms of the virus (referred to as clades). The second kit is a specific test detecting monkeypox viruses only (West African and Central African clade). For researchers interested in obtaining both of these results, a third kit is available that simultaneously detects orthopoxviruses plus provides information on whether a monkeypox virus is present or not (West African and Central African clade).   ]]> https://biospectrumindia.com/news/97/21300/transasia-bio-medicals-unveils-new-range-of-ivd-solutions.html https://biospectrumindia.com/news/97/21300/transasia-bio-medicals-unveils-new-range-of-ivd-solutions.html Mon, 23 May 2022 18:15:00 +0530 Mumbai-based Transasia Bio-Medicals recently unveiled two new Made in India products in its growing portfolio of in vitro diagnostics (IVDs), Erba XL 640 and ESL 30. The Erba XL 640, a fully automated random access clinical chemistry analyser with the autoloader, is designed to meet the high throughput needs of modern clinical laboratories. The Erba XL 640 helps establish more efficient workflows: it relieves staff from manual work, eases their burden, and aids in achieving faster TAT.Erba XL 640 has been validated at the Lokmanya Tilak Municipal General Hospital, Mumbai. Once programmed, the analyser is a walk-away system. Besides, random sample access, innovative robotics and an advanced user interface using windows embedded operating system optimise time management and streamline the workflow.In its Erythrocyte Sedimentation Rate (ESR) portfolio, Transasia announced the launch of ESL 30, an automated walkaway ESR system with a touch screen interface that improves workflow, turnaround time, and laboratory safety. ]]> https://biospectrumindia.com/news/97/21281/made-in-india-tb-infection-skin-test-called-c-tb-to-launch-in-2022.html https://biospectrumindia.com/news/97/21281/made-in-india-tb-infection-skin-test-called-c-tb-to-launch-in-2022.html Fri, 20 May 2022 00:00:00 +0530 Dr Mansukh Mandaviya, Union Minister for Health and Family Welfare, addressed the 35th Board meeting of the Stop TB Partnership through video-conference, on 19 May. Emphasizing on strengthening TB prevention activities, Dr Mandaviya announced that “starting later this year we will introduce a newly approved “made in India” TB infection skin test called ‘c-TB’”, stating that this cost-effective tool will be of immense benefit to other high burden countries as well. "Several new initiatives have been taken in India to turn the crisis into an opportunity, such as ‘bidirectional testing’ of TB with Covid-19, house-to-house TB detection campaigns, scale up of rapid molecular diagnostics at sub-district levels, use of Artificial Intelligence and Digital tools, Jan Andolan (peoples’ movement) and most importantly decentralization of TB services to Ayushman Bharat Health & Wellness Centres as part of comprehensive primary healthcare”, he added. ]]> https://biospectrumindia.com/news/97/21270/terumo-india-partners-with-argon-medical-to-expand-portfolio.html https://biospectrumindia.com/news/97/21270/terumo-india-partners-with-argon-medical-to-expand-portfolio.html Thu, 19 May 2022 00:00:00 +0530 Terumo India, the Indian arm of Terumo Corporation, has signed a partnership agreement with US-based Argon Medical, the market leader in specialty medical products, including guide wires, IVC filters and retrievals, bone and soft tissue biopsy needles and other products in India. Terumo and Argon have complementary portfolios, enabling Terumo to offer advanced medical solutions, providing support from diagnosis to treatment across the patient-care pathway. There is a significant unmet need to provide the latest technologies and tools for procedures such as Biopsies, AV Access and Deep Vein Thrombosis treatments. Argon’s portfolio comprising Biopsy, Thrombectomy and IVC Filters and Retrieval kits is expected to help bridge this gap for the Indian market.  Making the announcement, Shishir Agarwal, MD of Terumo India, said, "Bridging the industry gap in providing patient focused solutions for healthcare providers is a priority for Terumo. We are delighted to introduce Argon products in India, which represent the gold standard for Biopsy Devices and complements our portfolio of Vascular Solutions, Access and Core Products.” ]]> https://biospectrumindia.com/news/97/21245/neuberg-diagnostics-opens-coimbatore-lab.html https://biospectrumindia.com/news/97/21245/neuberg-diagnostics-opens-coimbatore-lab.html Mon, 16 May 2022 11:50:00 +0530 Neuberg Diagnostics has announced the opening of a processing lab in Coimbatore. The new lab in Coimbatore is equipped to conduct and process a wide variety of tests and is capable to process about 1000 samples in a day and delivering results within the given turnaround time which differs from test to test while maintaining the best-in-class quality. The diagnostics company also virtually opened labs at Ooty, Erode and a lab inside the women centre by Motherhood Hospitals and will soon open labs at Pollachi, Valparai etc and other 10 locations with open collection centres at 100 locations.    The lab will also focus on specialized testing needs for hospitals, nursing homes and smaller laboratories across Coimbatore, Tirupur, Pollachi, Udumalpet, Valparai, Avinashi and Nilgiris District. Additionally, Neuberg as a group is equipped to conduct futuristic tests such as genomics, proteomics, metabolomics, molecular biology and digital pathology. ]]> https://biospectrumindia.com/news/97/21229/neuberg-bose-laboratories-to-come-up-in-madurai.html https://biospectrumindia.com/news/97/21229/neuberg-bose-laboratories-to-come-up-in-madurai.html Thu, 12 May 2022 15:15:00 +0530 Neuberg Diagnostics and Madurai-based Bose Clinical Laboratory have decided to form a joint venture (JV) to establish a state of art central laboratory in Madurai catering to the needs of southern Tamil Nadu. The new company will be called Neuberg Bose Laboratories.   The JV Agreement was formalised in the presence of Dr GSK Velu, Founder and Chairman of Neuberg and Dr Puratchimani and Dr P Arivarasan of Bose Clinical Laboratory, A Ganesan, Vice Chairman, Dr Saranya Narayan, Technical Director & Chief Microbiologist, Aishwarya Vasudevan, Chief Operating Officer, Neuberg group were also present on the occasion.   The JV agreement between Neuberg and BCL paves the way for establishing a new state of art central laboratory besides upgrading the existing laboratory on Tamil Sangam Road. The JV company will also introduce new generation tests and will make available all high-end laboratory tests at an affordable cost. The JV will establish 10 laboratories and 100 plus collection centres in and around Madurai covering Madurai, Ramnad, Theni, Dindigul and Virudhunagar districts in the next two years.    ]]> https://biospectrumindia.com/news/97/21212/medtech-firm-agatsa-secures-rs-125-m-from-cardio-experts.html https://biospectrumindia.com/news/97/21212/medtech-firm-agatsa-secures-rs-125-m-from-cardio-experts.html Tue, 10 May 2022 19:40:00 +0530 Medtech startup Agatsa, based in Noida, has raised Rs 125 million to grow business operations and expand the product line. The company aims to revolutionise the cardiac care industry in India. With this new funding, the company is ready to scale new heights and make its products more accessible to its consumers.Key investors include seasoned medical experts Dr Ramakant Panda, MCh, Chief Consultant for Cardiovascular Thoracic Surgery and the Vice Chairman and MD of the Asian Heart Institute, BKC, Mumbai; Dr Tejas Patel, a renowned cardiologist and Chairman of Apex Heart Institute, Ahmedabad; Dr Ashish Parikh, Interventional Clinical Cardiologist and Chairman of Heart and Vascular Clinic in Delaware, US, Ahmedabad based Desai Family and Hemal Patel, a successful serial entrepreneur. Fairprep Ally (India) represented by CEO Nirav Thakkar, based in Ahmedabad, Gujarat has facilitated the funding transaction as the investment banker.Agatsa is also gearing up for expansion in the US and European markets with their CE and FDA certification under process. Agatsa has innovated the world’s first pocket 12-Lead ECG device which is 99% accurate and is being used by both doctors and heart patients in India for quick diagnosis/detection of cardiac problems. The device is very simple to use, affordable and pocket-sized anyone can easily use it on the go. ]]> https://biospectrumindia.com/news/97/21209/neuberg-diagnostics-expands-footprint-in-haryana.html https://biospectrumindia.com/news/97/21209/neuberg-diagnostics-expands-footprint-in-haryana.html Tue, 10 May 2022 17:30:00 +0530 Neuberg Diagnostics has launched a processing lab in Gurugram. The lab in Gurugram and other upcoming diagnostic labs will be wholly owned by Neuberg while the 100 touchpoints will be set up in the own or franchisee business model.    The new lab in Gurugram is equipped to conduct and process wide variety of tests. Additionally, Neuberg as a group is equipped to conduct futuristic tests such as genomics, proteomics, metabolomics, molecular biology, and digital pathology with advanced systems like NovaSeq6000. The new lab is capable to process about 1000 samples in a day and deliver results within the given turnaround time which differs from test to test while maintaining the best-in-class quality.    Neuberg plans to open labs in Faridabad, Panipat, Sonipat, Rohtak, Hisar, Karnal, Kurukshetra, and other key cities of Haryana.      ]]> https://biospectrumindia.com/news/97/21198/ficci-launches-self-regulatory-code-of-conduct-for-e-diagnostics-.html https://biospectrumindia.com/news/97/21198/ficci-launches-self-regulatory-code-of-conduct-for-e-diagnostics-.html Mon, 09 May 2022 14:45:00 +0530 The Federation of Indian Chambers of Commerce and Industry (FICCI) has launched a self-regulatory code of conduct for e-diagnostics in India through a virtual event. The code of conduct was launched in the presence of Manmeet K Nanda, Joint Secretary, Department for Promotion of Industry and Internal Trade, Government of India.    Self-Regulatory Code of Conduct for e-Diagnostics – prepared after several rounds of industry consultations by FICCI’s e-Pharmacy working Group aims to ensure adherence to the highest professional standards while delivering quality e-Diagnostic services till last mile in a safe and compliant manner.     This model fits well with the 'Ayushman Bharat Digital Mission' and 'Atmanirbhar Bharat Abhiyaan' and encompasses the vision of ‘Digital India’.     Some of the key components of the Code of Conduct include:  Responsibilities of the Technology Platform listing Medical Laboratories  Requirements for Safe Sample Collection and Transportation   Requirements for Clinical Sample Processing & Reporting  Requirements for Report delivery to the consumer  Customer grievances   Adherence to applicable regulatory requirements and technical specifications   Public Health Initiatives of the Government of India. ]]> https://biospectrumindia.com/news/97/21196/abbott-unveils-hbsag-next-assay-in-india-to-detect-hepatitis-b.html https://biospectrumindia.com/news/97/21196/abbott-unveils-hbsag-next-assay-in-india-to-detect-hepatitis-b.html Mon, 09 May 2022 13:30:00 +0530 Abbott has launched HBsAg Next Qualitative solution in India to enhance the detection of the Hepatitis B virus (HBV). This assay will help improve patient outcomes while maintaining safe blood supplies. The sensitive chemiluminescent microparticle immunoassay (CMIA) assists in the early and enhanced detection of HBV in human serum and plasma (blood) samples and population screening. The HBsAg Next Qualitative assay is an advanced, next-generation solution to better support the earlier detection of HBV. It detects HBV surface antigen (HBsAg) in human serum and plasma. Moreover, it overcomes traditional challenges by showcasing the highest level of assay performance required to detect infection in immunocompromised groups. ]]> https://biospectrumindia.com/news/97/21181/fujifilm-installs-endobronchial-ultrasound-system-at-esic-hospital-faridabad.html https://biospectrumindia.com/news/97/21181/fujifilm-installs-endobronchial-ultrasound-system-at-esic-hospital-faridabad.html Thu, 05 May 2022 12:50:00 +0530 Fujifilm India has installed their first state-of-the-art Endobronchial Ultrasound System (EBUS) at ESIC Medical College & Hospital, Faridabad to assist doctors in carrying out advanced diagnosis pertaining to diseases of the lungs.   The inauguration was done by Bhupender Yadav, Union Cabinet Minister of Labour and Employment, and Krishna Pal Gujjar, Minister of State of Power and Heavy Industries.    Installed at the hospital’s respiratory medicine department, the system was inaugurated by the Medical Commissioner of ESIC Dr Anshu Chhabra, Mukhmeet S Bhatia (Director General) and TL Yaden (Financial Commissioner).    The Endobronchial Ultrasound System (EBUS) is designed to support diagnosis and staging of various lung disorders. With its enhanced distal angulation and a slim design, this bronchoscope provides innovative ways for doctors to use in a range of procedures. The bronchoscopy aids doctors to diagnose lung disorders including inflammation, cancer or infections. Using a tube which goes from the patient's mouth to the windpipe and lungs, the EBUS scope uses a video camera and ultrasound probe to image the lungs and lymph nodes for accurate location and evaluation of the system.   ]]> https://biospectrumindia.com/news/97/21174/mylab-unveils-in-vitro-diagnostic-test-for-ankylosing-spondylitis.html https://biospectrumindia.com/news/97/21174/mylab-unveils-in-vitro-diagnostic-test-for-ankylosing-spondylitis.html Wed, 04 May 2022 16:25:00 +0530 Pune-based Mylab Discovery Solutions has unveiled DiscoverSeries HLAB*27 Detection Kit, an in-vitro diagnostic test for Ankylosing Spondylitis (AS). The RT-PCR test by Mylab comprises all necessary checks and controls, which result in almost 100 per cent accuracy. Based on real-time PCR technology, the test contains the necessary reagents for accurate determination of HLA-B27 genotype and qualitative detection of Ankylosing Spondylitis. It covers one of the highest numbers of the known geno/subtypes in comparison with other available kits in the market. This is a high throughput test and processes up to 90 samples in 80 minutes in a single run. Hasmukh Rawal, Founder and MD, Mylab Discovery Solutions, said “There has been an alarming increase in the incidence of AS, amongst Indian young adult. HLA-B27 is found in about 90% of patients with Ankylosing Spondylitis (AS). It is vital that disease is diagnosed at an early stage in order to control its progression. However, delayed diagnosis is considered as a significant challenge for the majority of patients. ]]> https://biospectrumindia.com/news/97/21155/genestore-unveils-facility-for-molecular-diagnostics-and-proteomics.html https://biospectrumindia.com/news/97/21155/genestore-unveils-facility-for-molecular-diagnostics-and-proteomics.html Fri, 29 Apr 2022 22:25:00 +0530 GeneStore's Founder, Anubhav Anusha, has announced the launch of the  company's Center of Excellence for Molecular Diagnostics and Proteomics in Gurugram, Haryana.The facility is dedicated to the development and manufacturing of RT-PCR kits for infectious diseases such as tuberculosis, HIV, dengue, Hepatitis C, Japanese Encephalitis Virus that contribute to a high public health burden in India.GeneStore's mission in India is to support the government in drastically lowering healthcare costs related to diagnostic testing for infectious diseases through its highly affordable RT-PCR testing kits."We have a pipeline of RT-PCR diagnostic kits for over 80 infectious disease pathogens that are relevant across diverse regions across India and the world," Anubhav Anusha, Founder, R&D Head and Global CEO of GeneStore. ]]> https://biospectrumindia.com/news/97/21141/wipro-ge-healthcare-unveils-made-in-india-ct-system.html https://biospectrumindia.com/news/97/21141/wipro-ge-healthcare-unveils-made-in-india-ct-system.html Thu, 28 Apr 2022 16:45:00 +0530 Wipro GE Healthcare has launched its next-generation Revolution Aspire CT (Computed Tomography) scanner. Revolution Aspire is an advanced imaging solution designed and manufactured end-to-end in India, at the newly launched Wipro GE Medical Devices manufacturing plant.   The CT system is equipped with higher imaging intelligence to improve clinical confidence when diagnosing diseases and anomalies.   The Revolution Aspire CT scanner empowers clinicians with increased operational efficiency with up to 50 per cent higher throughput. The rotation time in Revolution Aspire CT scanner has been increased by 20 per cent, enabling clinicians to provide faster diagnosis.   The scanner also comes with a new detector design and algorithm, along with smart features such as Smart MAR, that enables up to 30 per cent improved image quality.   The Revolution Aspire CT scanner has been manufactured at the recently launched Wipro GE Medical Device Manufacturing factory (MDM). The factory is one of 15 medical device manufacturers approved under the government’s PLI Scheme. Aligned to the National Agenda of ‘Atmanirbhar Bharat’, Wipro GE healthcare has invested a little over Rs 100 crore in this facility and aims to further boost local manufacturing of medical devices in India.             ]]> https://biospectrumindia.com/news/97/21128/teleradiology-solutions-inks-agreement-with-amtz.html https://biospectrumindia.com/news/97/21128/teleradiology-solutions-inks-agreement-with-amtz.html Wed, 27 Apr 2022 12:55:00 +0530 Bengaluru-based Teleradiology Solutions (TRS) has signed an agreement with Andhra Med Tech Zone (AMTZ) to establish a hub in the zone dedicated to providing remote radiology image reads focussed on government sector and public sector by expert radiologists supported by innovative artificial intelligence (AI) solutions.   Through this hub, AMTZ and TRS will reach out to pan-India government hospitals, state-wide rural health centres (including those under the National Health Mission), and public sector undertakings with hospitals where TRS will provide remote radiology services. A health cloud is conceptualised, which will ensure that all this radiologic data is archived in a central location for all government hospitals across India so that research institutions may use the data to conduct research projects.   The agreement was signed by Dr Jitendar Kumar Sharma, MD & CEO, AMTZ, and Kishor Joshi, Chief Business Officer, TRS, in the presence of senior management from both the organisations.   ]]> https://biospectrumindia.com/news/97/21123/clevergene-receives-pcpndt-licence-for-prenatal-genetic-tests.html https://biospectrumindia.com/news/97/21123/clevergene-receives-pcpndt-licence-for-prenatal-genetic-tests.html Tue, 26 Apr 2022 17:40:00 +0530 Clevergene, a deep tech genomics company offering genetic diagnosis and discovery genomics solutions, received the PCPNDT (Pre-Conception and Pre-Natal Diagnostic Techniques) license and will be offering prenatal diagnostics and preimplantation genetic screening tests.    With this certification Clevergene through its clinical diagnostics vertical The Gene Lab is launching a host of genetic tests that will improve outcomes for expectant parents and those planning a baby; these include Non-Invasive Prenatal Testing (NIPT) for detecting chromosomal aneuploidy in foetuses, preimplantation genetic screening, Products of Conception (POC) genetic testing as well as genetic counselling services.   Recently Clevergene had augmented its capacity with the installation of the latest Illumina NovaSeq 6000 DNA sequencing platform. The introduction of these tests bolsters the existing suite of postnatal genetic diagnostics tests by The Gene Lab for inherited diseases as well as cancer. The NIPT tests will be able to examine cell-free DNA found in maternal blood originating from the foetus to screen for chromosome abnormalities, including Down syndrome, Edwards syndrome, Patau syndrome, and triploidy. The screening test can be performed as early as nine weeks of gestation and there is no risk to the foetus. ]]> https://biospectrumindia.com/news/97/21120/srl-diagnostics-opens-new-lab-in-jamshedpur-.html https://biospectrumindia.com/news/97/21120/srl-diagnostics-opens-new-lab-in-jamshedpur-.html Tue, 26 Apr 2022 13:45:00 +0530 SRL Diagnostics has launched a new laboratory in Jamshedpur, Jharkhand. The state-of-the-art laboratory can conduct 30,000+ tests in a month ranging from simple routine tests to semi-specialised and specialised tests.   The citizens of Jamshedpur will now have access to SRL’s extensive test menu consisting of 3500+ tests and a range of well-curated preventive healthcare packages.   The advanced laboratory spread over 1100 sq ft has multiple laboratory divisions including haematology, biochemistry, clinical pathology, serology and microbiology. The laboratory is located at Kadma, Jamshedpur. With the addition of this new laboratory, SRL now has a network of 4 labs and 50+ collection centres across Jharkhand.    ]]> https://biospectrumindia.com/news/97/21076/translumina-unveils-dual-drug-polymer-free-coated-stent-in-international-markets.html https://biospectrumindia.com/news/97/21076/translumina-unveils-dual-drug-polymer-free-coated-stent-in-international-markets.html Tue, 19 Apr 2022 13:15:00 +0530 New Delhi-based Translumina has launched VIVO ISAR, its latest generation dual drug polymer-free coated stent (DDCS), in various international markets including Europe.    VIVO ISAR is the first Dual Drug Polymer-Free Coronary Stent technology, which brings together a stent with a superior safety profile without compromising the drug release kinetics.    VIVO ISAR is the first technology that uses Probucol, an antioxidant and lipid-lowering drug, as a carrier for releasing Sirolimus (an anti-restenotic drug) and thus creates a polymer-free DES platform with uncompromised safety and efficacy.    Translumina has launched VIVO ISAR in Italy & Spain and plans to roll it out in several markets across Europe, Latin America and APAC over the coming months.    ]]> https://biospectrumindia.com/news/97/21066/apollo-hospitals-collaborates-with-healthium-medtech.html https://biospectrumindia.com/news/97/21066/apollo-hospitals-collaborates-with-healthium-medtech.html Mon, 18 Apr 2022 13:30:00 +0530 The Apollo Simulation Centre, Vanagaram (ASC) has signed an agreement with Bengaluru-based Healthium Medtech, to offer advanced training in laparoscopic surgeries to young aspiring medical professionals.   The programme will be launched with the Laparoscopic Hernia Masterclass at the already available simulation centre at Apollo Speciality Hospitals, Vanagaram.    With laparoscopic surgery simulators, learners can begin to familiarise themselves with the performance methodologies. Basic and advanced procedures in laparoscopy can be learnt and updated using high-tech instruments, using real-time feedback and analytics. The initial courses of Lap. Hernia Masterclass will encompass commonly performed hernia procedures.   ]]> https://biospectrumindia.com/news/97/21058/neuberg-diagnostics-unveils-14-advanced-centres-in-chennai.html https://biospectrumindia.com/news/97/21058/neuberg-diagnostics-unveils-14-advanced-centres-in-chennai.html Fri, 15 Apr 2022 07:10:00 +0530 Neuberg Diagnostics has launched 14 Neuberg Advanced & Affordable Diagnostics & Health Checkup Centres in Chennai, with a pipeline of 100 such centres to come up in this financial year.   The new business segment will make diagnostics affordable and accessible to one and all. Services offered will include blood tests, X-rays, ECG and ultrasound Scans, health checkups, and home sample collection.   For this and other expansion initiatives in Tamil Nadu, the company has committed to invest Rs 200 crores in FY2022-23. Neuberg plans to expand its network to over 500 own and franchisee associate collection centres and 100 diagnostics and health check-up centres in Tamil Nadu this financial year.   The diagnosis and health check-ups can be availed at the 14 diagnostics and health checkup centres, each located in Anna Nagar, Ashok Nagar, Aynavaram, Hasthinapuram, Lyappanthangal, Kilpauk, Mylapore, Nanganallur, Ponnamallee, Peravallur, Ramapuram, Saligramam, Tambaram and Valasavakkam soon.   ]]> https://biospectrumindia.com/news/97/21054/trivitron-healthcare-sets-up-new-ultrasound-manufacturing-facility-in-mumbai-.html https://biospectrumindia.com/news/97/21054/trivitron-healthcare-sets-up-new-ultrasound-manufacturing-facility-in-mumbai-.html Thu, 14 Apr 2022 00:00:00 +0530 Trivitron Healthcare sets up its second ultrasound manufacturing facility in India at Patalganga Industrial Area, Mumbai. The new facility of Trivitron Healthcare will be manufacturing a wide range of advanced ultrasound devices and accessories, using the state of art manufacturing facilities and advanced technology as per the current market requirements to enhance medical practice in India and across the globe. The ultrasound products manufactured in the new manufacturing facility, will be sold under the brand name SonoRad, and are designed for large hospitals, healthcare institutions and individual radiology centres. With the integration of several technologies and advanced features, the series is backed with advanced quality. "In the coming years, with focused business strategies, we will come up with many new indigenous product portfolios and make India the top destination for advanced healthcare and revolutionary medical technologies.’ shares Chandra Ganjoo, Group Chief Executive Officer, Trivitron Healthcare. "The new facility will be manufacturing basic to advanced ultrasound devices to meet the everlasting demands of every aspect of the medical needs. The new SonoRad ultrasound series will provide important diagnostic information to our user, including maternal-fetal medicine who are dealing with the potential of high-risk pregnancies, as well as for urology and cardiac imaging,’ shares Sudip Bagchi, President, Trivitron Healthcare. ]]> https://biospectrumindia.com/news/97/21045/honeywell-unveils-new-blue-spectra-medical-grade-bio-fibre.html https://biospectrumindia.com/news/97/21045/honeywell-unveils-new-blue-spectra-medical-grade-bio-fibre.html Wed, 13 Apr 2022 11:50:00 +0530 Honeywell has announced the expansion of its Spectra Medical Grade (MG) Bio fiber portfolio with a blue-hued fibre that provides a strong visual aid to better differentiate between multiple suture sets in more complex surgeries. By creating clear colour contrast, the new fibre enables healthcare professionals to operate more accurately and efficiently, promoting greater safety and comfort for patients.    Engineered to be both ultra-lightweight and ultra-high-strength, Honeywell’s Spectra MG Bio fibre provides superior resistance to chemicals, fatigue and abrasion when compared to conventional polyethene fibre, making it an optimal solution for minimally invasive surgeries. Earlier this year, the technology received ISO 13485 certification.   The addition of a coloured variety to the Spectra MG Bio portfolio means the biomaterial can be utilised and trusted by a wide range of manufacturers building increasingly smaller, stronger and lighter devices. For the orthopaedic market, coloured Spectra MG Bio fibre provides new advantages for both existing devices and emerging trends used in corrective surgeries, such as robotics that reduce procedure durations and smart implants that flag dangerous bacterial presence. The advancement will help to support the growing worldwide market for orthopaedic devices, which is expected to reach a $43.1 billion value by 2024.    Honeywell’s new coloured Spectra MG Bio fibre is expected to be commercially available globally in Q3 2022, making the technology accessible to thriving orthopaedic device markets in regions including the US, EU, India, Asia Pacific and Latin America.  ]]> https://biospectrumindia.com/news/97/21034/intuitive-unveils-app-for-robot-assisted-surgery.html https://biospectrumindia.com/news/97/21034/intuitive-unveils-app-for-robot-assisted-surgery.html Mon, 11 Apr 2022 16:45:00 +0530 Intuitive's India arm has launched My Intuitive App (MIA), a unique platform for surgeons using da Vinci surgical systems in India. The My Intuitive App is a single point of access for surgeons and it makes surgery data discoverable and actionable.    The App captures surgeons' ergonomic preferences, timelines for cases and instruments used. The data is generated during the robotic-assisted surgical procedures performed using the da Vinci Surgical System and is analysed by the app to deliver actionable insights to help surgeons hone their skills and benchmark against their peers through global averages.    The mobile app is an important element of Intuitive’s digital and data support strategy. It serves as a digital portal to many parts of the Intuitive ecosystem — connecting its users to their personalised network of innovative robotic systems, learning, and services.   MIA also provides access to the Intuitive Learning Platform, an in-depth learning environment with videos, learning plans, simulation models, and other educational resources. ]]> https://biospectrumindia.com/news/97/21030/mahajan-imaging-opens-diagnostic-facility-for-precision-and-predictive-medicine.html https://biospectrumindia.com/news/97/21030/mahajan-imaging-opens-diagnostic-facility-for-precision-and-predictive-medicine.html Mon, 11 Apr 2022 11:05:00 +0530 Mahajan Imaging has forayed into precision and personalised medicine by launching an integrated centre of excellence in diagnostics at Safdarjung Development Area, New Delhi. The new centre combines state-of-the-art technology in medical imaging with a full-fledged pathology and genomics lab as well as an R&D department and an AI startup.   Vice President of India M Venkaiah Naidu delivered the inaugural address at the launch of the new centre. He emphasised the need for early diagnosis through screening programmes and preventive health checks at the population level. He further remarked on the role of Public-Private Partnership and emerging technologies such as artificial intelligence in providing access to high-quality, affordable diagnostics across the country.   The centre, spread across five floors, is designed with aesthetics for maximum patient comfort and is equipped with state-of-the-art technologies including radiology and nuclear medicine. It consists of three MRI scanners, Dual Energy Spectral CT, Digital PET CT, Dual Head Gamma Camera, radionuclide therapy with Lutetium, Full Field Digital Mammography with 3DTomosynthesis, 3D / 4D Ultrasounds, Cone Beam Dental CT, DEXA bone densitometry, non-invasive cardiac lab, digital fluoroscopy, and radiography.  ]]> https://biospectrumindia.com/news/97/21015/policy-transformations-to-accelerate-adoption-of-medtech-innovations-report.html https://biospectrumindia.com/news/97/21015/policy-transformations-to-accelerate-adoption-of-medtech-innovations-report.html Thu, 07 Apr 2022 17:05:00 +0530 Wadhwani Foundation, Cyient and Xynteo’s Vikaasa have published a report titled 'Accelerating Innovation and scale-up of SMEs in MedTech.' The report highlights two separate strands of analysis: firstly, understanding the challenges and opportunities; secondly, a proposal for recommendations and the way forward to accelerate the adoption of MedTech innovations in public health. The paper aims to capture SMEs' need for collaborative platforms and policy transformations to enhance the domestic manufacturing of medical devices and reduce import dependence.    The paper brings to the fore impact of unclear regulations as one of the biggest impediments to the success of the med tech industry in India as well as identifies critical gaps as articulated by varied stakeholders around regulations and standards, expanding scale, and adoption of innovations and talent development. Interestingly, the study revealed that only 37 types of medical equipment are regulated in India. At the same time, the market remains flooded with low-cost imports with very high trading margins and long credit periods. Impacting the Indian market, thus reducing the competitiveness of Indian medical devices companies and increasing instances of counterfeiting.   The paper highlights the need for Indian medical technology companies to generate enough clinical evidence about their products coupled with peer-reviewed journals, in absence of which, hospitals are unlikely to procure the same for use in their facilities. Indian companies need to invest more in the training of their employees – in sales, marketing, demonstrations, clinical support, hardware repairs, software troubleshooting, regulatory pathways, etc. Initiatives like the International Biomedical Skills Consortium help Indian companies enhance the skills of their employees coupled with government support through the Health Sector Skills Development Council which can help Indian companies enhance the skills of their employees.  ]]> https://biospectrumindia.com/news/97/21001/manipal-healthmap-acquires-hyd-based-medcis-pathlabs-.html https://biospectrumindia.com/news/97/21001/manipal-healthmap-acquires-hyd-based-medcis-pathlabs-.html Wed, 06 Apr 2022 07:00:00 +0530 Manipal HealthMap, a leading integrated diagnostic service provider in India, announced the acquisition of Hyderabad-based Medcis Pathlabs in an all-cash deal for a majority stake. With this deal, Manipal HealthMap expands its footprint to 19 additional centres which takes the total number to 60 centres across 14 states, strengthening its position as a major integrated diagnostic services brand. Through this acquisition, Manipal HealthMap will have access to additional 19 laboratories, including one NABL accredited central laboratory (based in Hyderabad). Headquartered in Hyderabad, Medcis Pathlabs, currently operates through 17 labs located across the southern, western, and northern parts of the country. The combined entity will also have a consolidated back-end operation of its labs at common locations of Pune, Delhi, Bengaluru, and Nagpur. ]]> https://biospectrumindia.com/news/97/21003/srl-diagnostics-skye-air-mobility-to-revolutionise-logistics-in-diagnostics-industry.html https://biospectrumindia.com/news/97/21003/srl-diagnostics-skye-air-mobility-to-revolutionise-logistics-in-diagnostics-industry.html Wed, 06 Apr 2022 02:15:00 +0530 Skye Air Mobility, a drone delivery logistics provider has signed a long-term agreement with SRL Diagnostics. The partnership between Skye Air Mobility & SRL Diagnostics is expected to revolutionise logistics in the diagnostics industry. This partnership is unique in the pathology sector since it will leverage drone delivery technology to create a faster supply chain for collecting samples and transporting them to labs in Gurugram and Mumbai. The duo will conduct BVLOS drone delivery trial flights in designated green zones in Gurugram and Mumbai regions. From April 8 onwards, around 60 test flights would be undertaken from Fortis Hospitals/Collection centres to SRL Labs in both cities. Anand K, CEO, SRL Diagnostics said, “We are shortly beginning our eight-day trial in Mumbai, and Gurugram. Post the successful trial, long-range deliveries will also begin which will be particularly useful in congested locations, hilly regions, and mountainous terrain. This will help us build efficiencies for specialised and super-specialised tests that are typically performed only at our Global Reference Laboratories. Since the time taken for sample transfer is cut down, we will have better temperature control for samples, especially during the summer months.”   ]]> https://biospectrumindia.com/news/97/20980/mylab-to-foray-into-routine-lab-testing-equipment-and-reagent-biz.html https://biospectrumindia.com/news/97/20980/mylab-to-foray-into-routine-lab-testing-equipment-and-reagent-biz.html Thu, 31 Mar 2022 15:10:00 +0530 Pune-based Mylab Discovery Solutions plans to launch an entire range of routine diagnostic kits and devices in conventional and POCT (point of care testing) format. It will include the devices and kits for three major sub-segments of the market - immunology, biochemistry and haematology. This will nearly complete the company’s portfolio for diagnostics laboratories which until now included molecular (RT-PCR) test kits and devices and rapid/self-tests.    With this expansion in product lines, now the labs can use Mylab’s devices and reagent kits to do all routine tests such as liver panels, cardiac profile, urine panels, hormone panels, fever panels, kidney function tests, cancer markers and much more.    For the research and development of these products, the company has earmarked Rs 100 crores and several devices and reagent kits are already in development at its Pune-based Innovation Centre for Medical Devices.   The company plans to start rolling out these products in the third quarter and roll out pan India through existing and new distributorships. The company is also building a team to reach rural and urban customers. The team will be trained at the state-of-the-art training centre of the company.   Mylab aims to place its products in 1000 labs within the first six months from the time of launch and acquire a market share of 10 pr cent by the end of 2024 with its reach to more than 20000 labs.   The company expects a total of 10 different devices and 120 test parameters to be rolled out in the next financial year under this business segment. The company will use its manufacturing facility at Lonavla and the upcoming facility at AMTZ, Vizag for the production of these devices and kits.     ]]> https://biospectrumindia.com/news/97/20967/next-gen-haemostatic-technology-launches-in-india.html https://biospectrumindia.com/news/97/20967/next-gen-haemostatic-technology-launches-in-india.html Wed, 30 Mar 2022 13:30:00 +0530 SeraSeal, an innovative primary haemostatic agent designed to stop bleeding on contact and within seconds for arterial haemorrhages, has been launched in India. It consists of agar and bovine factor proteins II a VII a and IX a and X a and acts as a catalyst in the clot formation process. This single-component system can tackle any bleeding situation with the potential to save many lives. Clinical studies and clinical use have demonstrated SeraSeal’s unique formulation to be effective in a wide range of coagulopathies. When SeraSeal is applied to a wound, it does not create inflammation or damage to the tissues allowing the wound healing to occur sooner. A one-component haemostatic agent SeraSeal requires no mixing or preparation and is available in multiple delivery systems to administer any wound to any part of the body. Controlling bleeding, it reduces the substantial need for blood transfusions, thereby, reducing risk and cost to the patient. In addition, cost savings are realised through SeraSeal by reducing surgical time, wherein in some cases, the savings are as much as 50 per cent and shorter hospital stays. Ajaypal Singh Randhawa, Founder CEO, Swasth Kare India is hopeful this will bring about a sea-change in the healthcare landscape by reducing blood loss, whole blood units needed, surgical time and tissue conservation, every stage in healthcare will improve. ]]> https://biospectrumindia.com/news/97/20955/fujifilm-india-unveils-new-range-of-ct-mri-and-ultrasound-machines-in-india.html https://biospectrumindia.com/news/97/20955/fujifilm-india-unveils-new-range-of-ct-mri-and-ultrasound-machines-in-india.html Mon, 28 Mar 2022 15:30:00 +0530 Fujifilm India, a leader in diagnostic imaging and medical system technology, has unveiled a new range of products at the 74th National Annual Conference of IRIA 2022.   The latest portfolio includes a plethora of products offering complete and integrated solutions for diagnostic purposes including CT, MRI, X-ray, AI, PACS, endoscopy and ultrasound systems through the Scenaria View, Supria series, The Echelon Smart and Arietta series   Scenaria View (128 slice CT Solution) is a CT solution that provides dependable routine application capabilities with available advanced clinical modules for Interventional CT, extended coverage Shuttle Scanning (for Perfusion Exams), Cardiac CTA and Dual Energy examinations.    Supria (32/128 CT Solution) is an evolved CT device, employing the latest technologies such as whole-body sub-millimetre imaging and dose reduction technologies.    The Echelon Smart (1.5T Superconductive MRI) is based on Fujifilm’s proprietary technology, and opened the potential for 1.5T systems, providing superb image quality and superior install flexibility, inherited from permanent-magnet MRI systems. It comes with noise reduction technology for a patient-friendly examination.   The ARIETTA (Series of Ultrasound) is designed to provide high-quality imaging across a broad clinical range that includes abdominal, cardiac, and vascular applications.    ]]> https://biospectrumindia.com/news/97/20940/siemens-healthineers-launches-latest-innovations-in-medical-imaging.html https://biospectrumindia.com/news/97/20940/siemens-healthineers-launches-latest-innovations-in-medical-imaging.html Fri, 25 Mar 2022 15:35:00 +0530 Siemens Healthineers showcased the latest products and technologies in radiology at 74th National Conference, IRIA 2022, Bengaluru. The company introduced its unique solutions in MRI and CT portfolio- MAGNETOM Free.Star and NAEOTOM Alpha.MAGNETOM Free.Star belongs to the new generation of scanners from Siemens Healthineers based on our revolutionary High-V MRI Platform.   It is built on the latest DryCool technology, it is a virtually helium-free scanner with an ultra-compact footprint that is far easier to install.  Based on the revolutionary direct signal conversion of its QuantaMax detector, NAEOTOM Alpha offers high-resolution images at minimal dose, spectral information in every scan, and improved contrast at lower noise. Photon-counting CT will advance medical diagnostics towards precise, non-invasive diagnosis in cardiology, pulmonology, oncology, and emergency medicine.Dr Umesh Krishnamurthy, Professor, and Head, Department of Radiology, M S Ramaiah Hospital, Bengaluru, and Organising Chairman of IRIA 2022 unveiled the product during IRIA 2022.    ]]> https://biospectrumindia.com/news/97/20930/srl-diagnostics-unveils-whole-genome-sequencing-test-for-tb.html https://biospectrumindia.com/news/97/20930/srl-diagnostics-unveils-whole-genome-sequencing-test-for-tb.html Wed, 23 Mar 2022 00:00:00 +0530 SRL Diagnostics has announced the launch of an advanced genomic test for tuberculosis (TB). The test is expected to reduce time taken to diagnose multi-drug resistant tuberculosis and offer a complete resistance profiling to 18 different TB drugs. Speaking on the launch of the test, Anand, CEO, SRL Diagnostics said “The Whole Genome Sequencing test enables a clinician to decide the most appropriate drug regimen by providing an accurate and clinically relevant diagnosis within few days. In addition to its use in accurate detection of drug resistance, the test has the potential to revolutionize epidemiology studies and disease surveillance." The Whole Genome Sequencing test involves rapid and comprehensive genomic analysis for detection of drug resistance markers (18 drugs), strain typing, mixed infection and co-infections. The test can overcome the time and cost limitations of traditional culture based drug susceptibility testing as it can more rapidly detect all mutations known to be associated with drug resistance for any TB drug in one step.   ]]> https://biospectrumindia.com/news/97/20914/mylab-to-open-manufacturing-facility-in-vishakhapatnam-for-advanced-diagnostics.html https://biospectrumindia.com/news/97/20914/mylab-to-open-manufacturing-facility-in-vishakhapatnam-for-advanced-diagnostics.html Mon, 21 Mar 2022 00:00:00 +0530 Pune-based Mylab Discovery Solutions has announced the opening of a new manufacturing facility at Andhra Pradesh MedTech Zone (AMTZ) in Vishakhapatnam. The brand-new facility will utilize the latest technology to manufacture a wide range of high-quality molecular diagnostic products and increase the company's manufacturing capacity. Spread over 43,000 square feet, the facility will be set up to cater to the increasing demand for transformative molecular testing in India and across the world for early and accurate diagnosis. Speaking on the occasion, Debarshi Dey, Director of Mylab Discovery Solutions, said, "Expanding our manufacturing footprint enables us to strengthen indigenous production capacity and continue to produce the diagnostic kits of tomorrow." The new manufacturing facility is under construction and will officially start operations from June 2022 after receiving the necessary approvals. The new facility will increase the existing production capacity to 500,000 per day, and create new jobs for skilled workers who will use advanced technology to produce life-changing diagnostics and therapeutics to make life better for people around the world.   ]]> https://biospectrumindia.com/news/97/20902/iit-delhi-collaborates-with-us-for-research-in-cobotics-ai.html https://biospectrumindia.com/news/97/20902/iit-delhi-collaborates-with-us-for-research-in-cobotics-ai.html Thu, 17 Mar 2022 00:00:00 +0530 I-Hub Foundation for Cobotics (IHFC), the Technology Innovation Hub (TIH) of the Indian Institute of Technology Delhi (IIT-D) has collaborated with the National Science Foundation (NSF), USA to expand frontiers in research and development work related to Cobotics and associated technologies especially Artificial Intelligence (AI) and Machine Learning (ML). The Department of Science & Technology (DST), Government of India, enabled this partnership in association with the Indian Embassy in Washington, USA, and the IHFC was identified as one of the most sought-after institutions for this collaboration. “I-Hub Foundation for Cobotics (IHFC), the TIH of IIT Delhi, as per a  latest development will provide an additional Rs 50,00,000/ towards the funding of the Cobotics projects for research and development. The IHFC will fund researchers working in the area of  Medical Simulations, Drone Technology & Applications, Healthcare Robotics, Rehabilitation Robotics, Human-Robot Interactions, Intelligent Sensing & Secured Communications, and Industry 4.0 & beyond,” said Dr. S.K. Saha, Professor at IIT Delhi and Project Director, IHFC. The partnering institutions, IIT Delhi and NSF, have strong expertise in engineering and have strong linkages with researchers in areas such Cobotics/Robotics, AI and ML.   ]]> https://biospectrumindia.com/news/97/20896/boston-scientific-expands-footprint-in-india-with-second-rd-centre.html https://biospectrumindia.com/news/97/20896/boston-scientific-expands-footprint-in-india-with-second-rd-centre.html Wed, 16 Mar 2022 00:00:00 +0530 Boston Scientific Corporation has launched a state-of-the-art R&D Centre in Pune, its second in India, with the aim of capitalizing on the country’s R&D expertise and providing diverse opportunities for engineers and innovators in the country. The new facility was inaugurated by Dr Vinod K. Paul, physician scientist and serving Member of NITI Aayog. Boston Scientific, a US-based medical device company and a leading innovator of less invasive medical solutions, established its first India R&D Centre in Gurgaon in 2014. The Centre has since contributed to more than 100 patent filings and innovation ideas. The second India R&D Centre in Pune will initially employ 170 engineers, bringing the total number of Boston Scientific’s R&D employees in India to more than 300. The new Centre is spread across 45000 square feet and equipped with an array of sophisticated medical equipment and simulators to further facilitate the R&D process and build more R&D capacity. Speaking at the inauguration, Ralph Cardinal, Vice President R&D Boston Scientific APAC said, “Globally, Boston Scientific invests over $1 billion in R&D every year and we are pleased to further include India with the opening of this second R&D Centre in Pune.” The new R&D Centre will provide expertise to all of the company’s diverse therapy areas, namely Interventional Cardiology, Peripheral Interventions, Cardiac Rhythm Management, Endoscopy, Neuromodulation, and Urology and Pelvic Health.    ]]> https://biospectrumindia.com/news/97/20899/srl-diagnostics-roche-diagnostics-india-to-unveil-laboratory-of-the-future.html https://biospectrumindia.com/news/97/20899/srl-diagnostics-roche-diagnostics-india-to-unveil-laboratory-of-the-future.html Wed, 16 Mar 2022 00:00:00 +0530 SRL Diagnostics is all set to transform its lab at Fortis Memorial Research Institute with Roche Diagnostics’ integrated analyser series.  With this installation, SRL Diagnostics is well on the path to establishing an Integrated Core Lab. This integration will bring enormous benefits to SRL and its patients. The inauguration of the new breakthrough platform was done by Anand K, CEO, SRL Diagnostics along with Dr Ritu Mittal Garg, Zonal Director Fortis Memorial Research Institute and Narendra Varde, Managing Director, Roche Diagnostics India and Neighboring markets.  Laboratories of the future will encompass integrated systems where lab technicians will no longer need to work in different labs for different disciplines. Instead, their multidisciplinary connectivity will allow a single centralized, automation system to include a single user interface that can run the entire system.  “Diagnostic tools are vital in improving patient care by enabling clinicians to make medical decisions accurately. Labs today want to offer the best but need integrated systems that can offer more. Therefore, demand for increased lab productivity and efficiency per invested space and budget continues to rise. High performing labs need an efficient mix of a broad test menu and fast result turnaround time. The cobas analyzer series consolidates 230+ tests including innovative tests on maternal screening, Alzheimer’s disease, cardiac risks etc. on one system, where most of these samples utilize just a single tube of blood sample. It can also achieve 99% per cent uptime, or 18 minutes or less TAT on 93 per cent of parameters ”, said Narendra Varde, Managing Director, Roche Diagnostics India & Neighboring Markets.''   ]]> https://biospectrumindia.com/news/97/20887/tata-1mg-strengthens-diagnostics-foothold-with-first-reference-lab-in-india.html https://biospectrumindia.com/news/97/20887/tata-1mg-strengthens-diagnostics-foothold-with-first-reference-lab-in-india.html Tue, 15 Mar 2022 00:00:00 +0530 Tata 1mg, Gurugram-based digital health platform, has announced the launch of its first Reference Lab based in Delhi, which was inaugurated by Dr Indu Bhushan - Former CEO, Ayushman Bharat. The state of the art reference diagnostics laboratory enables an extensive catalog of tests, can process upto 4000 tests an hour and joins Tata 1mg’s already extensive nationwide network of 8 diagnostic labs that serve over a million customers each year, across 30 cities. The new Reference Lab in Delhi is spread across 24000 sq. feet area and is equipped to process more than 4000 tests per hour across pathology and microbiology specializations. Tata 1mg’s network of labs works with best in class quality assurance and provides a comprehensive range of routine, specialized and esoteric tests covering the whole spectrum of clinical diagnostics. Technology-enabled and fully automated systems track end to end sample movement from collection to reporting, thus eliminating pre-analytical errors. The labs are led by a strong and highly experienced team of pathologists, microbiologists, biochemists and molecular scientists who are further supported by the brand’s existing network of 1000+ phlebotomists for home sample collection.   ]]> https://biospectrumindia.com/news/97/20880/illumina-trivitron-expand-use-of-next-generation-sequencing.html https://biospectrumindia.com/news/97/20880/illumina-trivitron-expand-use-of-next-generation-sequencing.html Mon, 14 Mar 2022 00:00:00 +0530 Illumina Singapore, subsidiary of US-based Illumina Inc and Chennai-based Trivitron Healthcare have entered into a strategic partnership to develop and expand the use of next-generation sequencing (NGS)-based in-vitro diagnostic tests (IVD) in India. Over the next four years, Illumina and Trivitron intend to develop and distribute a suite of standardized, commercial IVD assays to deliver an effective and non-invasive way of diagnosing cancers, determining infectious pathogens, and identifying prenatal diseases. The assays will be cost-effective, easy to use, and have high throughput capabilities. In numerous neurological and rare disorders, where clinical characteristics can be confusing, NGS-based approaches have demonstrated considerable increases in disease detection rates over other approaches. Similarly, tailored NGS panels have allowed for the rapid, non-invasive, and cost-effective diagnosis and prognosis of a variety of malignancies, as well as the detection of infectious pathogens and the identification of a variety of prenatal disorders. ]]> https://biospectrumindia.com/news/97/20881/niramai-bags-us-fda-clearance-for-medical-device-smile-100-system.html https://biospectrumindia.com/news/97/20881/niramai-bags-us-fda-clearance-for-medical-device-smile-100-system.html Mon, 14 Mar 2022 00:00:00 +0530 Niramai Health Analytix, a deep-tech Bengaluru-based healthcare startup offering a novel radiation-free, non-touch, accurate, breast cancer screening solution in India, has now received US FDA clearance for their first device called SMILE-100 System. The SMILE-100 System is a breast thermography device that helps healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It can be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel. It is intended for use as adjunctive diagnostic imaging for thermally significant indications in the breast region. The SMILE-100 System assists experts to visualize high thermal activity patterns clearly demarcated on thermal images as hotspots and can enable healthcare professionals to make better decisions in breast cancer screening and diagnosis.  Another unique feature of SMILE-100 is use of their patented artificial intelligence-based algorithms to check the quality of input thermal images, which can greatly reduce the errors in thermal image capture and enable low skilled health workers to confidently perform the imaging. ]]> https://biospectrumindia.com/news/97/20872/lupin-diagnostics-unveils-first-reference-laboratory-in-east-india.html https://biospectrumindia.com/news/97/20872/lupin-diagnostics-unveils-first-reference-laboratory-in-east-india.html Thu, 10 Mar 2022 00:00:00 +0530 Global pharma major Lupin has announced that Lupin Diagnostics has launched its first Reference Laboratory in East India in Kolkata. The new Reference Laboratory at Kolkata has capabilities to conduct a broad spectrum of routine and specialized tests in the fields of molecular diagnostics, cytogenetics, flow cytometry, histopathology, cytology, microbiology, serology, haematology, immunology and routine biochemistry. Lupin Diagnostics is also setting up laboratories in West Bengal, Assam, Bihar, Jharkhand and Orissa to comprehensively cater to the East India region. These processing labs will be located in the cities of Siliguri, Berhampore, Asansol, Burdwan and Bankura in West Bengal, along with Guwahati (Assam), Patna (Bihar), Ranchi and Dhanbad (Jharkhand) and Bhubaneshwar (Orissa). These labs will be connected to Lupin’s franchise collection centers, LupiMitra. Lupin Diagnostics has more than 100 LupiMitra already enrolled for its East India operations. Ravindra Kumar, Vice President and Head - Lupin Diagnostics said, “Diagnostics is the first step in disease management. Lack of timely and accurate diagnosis limits the possibility of effective treatment. According to industry estimates, evidence-based treatment is the new normal in India, and about 70% of treatment decisions are now based on diagnostics tests. We are very pleased to now offer our services in East India, a very important region for us.”   ]]> https://biospectrumindia.com/news/97/20838/medtronic-india-launches-minimed-780g-system-for-diabetes-management.html https://biospectrumindia.com/news/97/20838/medtronic-india-launches-minimed-780g-system-for-diabetes-management.html Mon, 07 Mar 2022 16:10:00 +0530 Medtronic has launched MiniMed 780G system in India. The MiniMed 780G system is a next-generation closed-loop insulin pump system for the treatment of type 1 diabetes in people aged seven to 80 years. The system automates the delivery of both basal insulin and correction boluses every five minutes to help people with diabetes avoid highs and lows with greater ease.    The MiniMed 780G system enables the personalisation of glucose goals with an adjustable target setting as low as 100 mg/dL — lower than any other advanced hybrid closed-loop system — and is designed to help stabilise blood sugar levels and further improve glucose control. Patients who participated in a clinical study provided feedback that the MiniMed 780G system 'made life with diabetes and control so much easier' and that it made 'life significantly easier.'   The system is part of the new Medtronic portfolio of insulin pumps with smartphone connectivity via Bluetooth technology. This advancement allows users and their care partners to see real-time glucose data and trends on compatible iOS and Android smartphones via apps. Additionally, healthcare providers will find that managing patients on the system is simple as there are only a few settings that need adjustment to enable optimal use of the technology. ]]> https://biospectrumindia.com/news/97/20825/healthium-strengthens-commitment-towards-sports-medicine-in-india.html https://biospectrumindia.com/news/97/20825/healthium-strengthens-commitment-towards-sports-medicine-in-india.html Fri, 04 Mar 2022 00:00:00 +0530 Bengaluru-based Healthium Medtech has inaugurated the ‘Sport of Life’ initiative, with Abhinav Bindra Foundation Trust (ABFT).   ABFT aims to support injured players in need with the cost of medical treatment, doctors, surgeries and rehabilitation facilities to recover from sports injuries and carry on with their careers.   Healthium will provide its arthroscopy implants required for the surgeries free of cost. According to an Injury Surveillance Report by NCA last year, 14.75 % of players sustained shoulder injuries, 13.11% of players sustained knee injuries and almost 74 % players suffer from career-threatening Anterior Cruciate Ligament (ACL) injuries in the 1st two years of return to sport. Healthium has created over 300 SKUs for knee and shoulder procedures, designed and developed in-house, backed by 50+ patents applied and granted in U.S and India. This “Make in India, for the world” portfolio offers a wide range of implants and equipment to treat soft tissue conditions in the shoulders and knees such as anterior cruciate ligament reconstruction, posterior cruciate ligament injuries, other ligament repair & reconstruction and meniscal repair, so that despite injuries the ‘Sport of Life’ does not stop. ]]> https://biospectrumindia.com/news/97/20786/krsnaa-diagnostics-secures-five-year-contract-with-himachal-pradesh-govt.html https://biospectrumindia.com/news/97/20786/krsnaa-diagnostics-secures-five-year-contract-with-himachal-pradesh-govt.html Mon, 28 Feb 2022 13:40:00 +0530 Pune-based Krsnaa Diagnostics has announced its agreement with the Government of Himachal Pradesh. The tenure of the contract awarded will be up to five years and will be implemented in all government health institutions in the entire state of Himachal Pradesh.    As per the contract, Krsnaa Diagnostics will be installing, operating and maintaining routine and advanced laboratory testing facilities at selected public health institutions. These include government medical colleges of the state, district/ general hospitals owned by the state government and community health centres (CHCs).    In February this year, Krsnaa Diagnostics was awarded the contract to develop, operate and maintain radiology imaging diagnostic centres in government multi-speciality hospitals in Chandigarh on Public-Private Partnership (PPP) basis.   ]]> https://biospectrumindia.com/news/97/20771/parexel-n-lorem-foundation-to-support-investigational-therapies-for-nano-rare-patients.html https://biospectrumindia.com/news/97/20771/parexel-n-lorem-foundation-to-support-investigational-therapies-for-nano-rare-patients.html Fri, 25 Feb 2022 17:10:00 +0530 Clinical research organisation Parexel has announced a new partnership with n-Lorem Foundation. The partnership aims to support of n-Lorem’s effort to discover and provide experimental antisense oligonucleotide (ASO) medicines to nano-rare disease patients (1 to 30 patients worldwide) for free, for life.   Parexel brings significant expertise to the partnership, having managed approximately 400 rare disease clinical studies over the past five years that contributed to 17 FDA drug approvals.   Stanley T Crooke, Founder, CEO and Chairman, n-Lorem Foundation said, “Parexel will provide the necessary systems to assure that each patient’s natural history and clinical studies are well managed, which will be very important as we accept more nano-rare patients and collect data that informs our future decisions and aggregate experience.” ]]> https://biospectrumindia.com/news/97/20732/apeejay-stya-university-serb-organise-conference-on-nanomedicine-and-medical-devices-in-healthcare.html https://biospectrumindia.com/news/97/20732/apeejay-stya-university-serb-organise-conference-on-nanomedicine-and-medical-devices-in-healthcare.html Thu, 24 Feb 2022 08:30:00 +0530 The 3rd National Conference on Nanomedicine and Medical Devices in Healthcare was recently organised by the Apeejay Stya Univesity in support of the Science and Engineering Research Board (SERB), DST, Government of India.   The conference witnessed eminent scientists and experts from the field of nanomedicine and medical devices technologies across the country, who put forward their perspectives on various aspects of the industry along with advocating the consolidation of the sector.    The conference was also a platform for many faculty members, PhD scholars including postgraduate and undergraduate students to exhibit their valuable research/review through scientific poster presentations on various aspects related to the theme.    Prof Alok R Ray (Ex-Consultant Professor, School of International Biodesign, All India Institute of Medical Science, New Delhi), said: “Most of the polymers that are used in medical devices are made in India. But we do not produce the final product because people from various fields like pharmaceutical, hardware, bioelectronics, nanodevices, etc, do not work together so much."   Prof Raj S Dhankar, Vice-Chancellor, Apeejay Stya University (ASU) highlighted the facts how India played a vital role during the last covid waves and contributed effectively in quality medicine and vaccines to address the domestic as well as global demand.    Dr Vivekanandan Kalaiselvan, Senior Principal Scientific Officer, Indian Pharmacopoeia Commission, Ghaziabad, spoke about “Materiovigilance Programme of India: Roles and responsibilities of Pharmacy professionals” while elaborating on the role of Indian Pharmacopoeia Commission that obtains scientific data, analyses and communicates it to the regulating authority.    Dr Manish Diwan, Head-Strategy Partnership & Entrepreneurship, Development BIRAC, Department of Biotechnology, Govt of India spoke about the growing startup ecosystem of the country.    Dr Arvind Bansal, Professor of Pharmaceutics, NIPER, Mohali, Chandigarh, spoke on nanocrystals—the approaches used for its generation and its various applications.    Dr Dhiraj Kumar Chopra, Vice President & Head Sterile R&D, Amneal Pharmaceuticals, Ahmedabad, Gujarat, spoke on the key factors considered in polymer selection for drug delivery system, the importance of managing the rate of polymer degradation, use of polymers for depot injections that are non-toxic, controlled erosion and biocompatible, among others.                                Prof Bansi D Malhotra, DST-SERB (Science & Engineering Research Board, Govt of India) Distinguished Fellow & Adjunct Professor, Department of Biotechnology, Delhi Technological University (DTU), spoke about how nanomaterials-based conducting paper can be helpful in the development of biomolecular electronic devices like biosensors for cancer detection. ]]> https://biospectrumindia.com/news/97/20642/datar-cancer-genetics-bags-fda-grant-for-prostate-cancer-detection-blood-test.html https://biospectrumindia.com/news/97/20642/datar-cancer-genetics-bags-fda-grant-for-prostate-cancer-detection-blood-test.html Tue, 15 Feb 2022 12:45:00 +0530 Datar Cancer Genetics, with operations in the UK, Germany and India, has announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra-Prostate' blood test to detect early-stage prostate cancer. This is the second test from the company that has received the Breakthrough Device Designation from the US FDA.    Studies have shown that TriNetra-Prostate can detect early-stage cancer with high accuracy (>99 per cent) without any false positives. TriNetra-Prostate requires 5 ml blood and is indicated for males of age 55-69 years with serum PSA of 3 ng/mL or higher. TriNetra-Prostate is based upon the detection of prostate adenocarcinoma specific Circulating Tumor Cells (CTCs) in the blood.   "The test can help reduce the number of biopsies among individuals with benign conditions of the prostate and it can also improve detection rates among those who do have prostate cancer. With our proprietary CTC-enrichment and detection technology, there is virtually no risk of false positives among individuals who do not have prostate cancer," said Dr Vineet Datta, Executive Director, Datar Cancer Genetics. ]]> https://biospectrumindia.com/news/97/20635/voxtur-bio-unveils-neutralising-antibody-test-kit-for-covid-19.html https://biospectrumindia.com/news/97/20635/voxtur-bio-unveils-neutralising-antibody-test-kit-for-covid-19.html Mon, 14 Feb 2022 17:25:00 +0530 Mumbai-based in-vitro diagnostics (IVD) company Voxtur Bio has launched an advanced point of care rapid Neutralising antibody test kit VoxPress COVID-19 for detecting neutralising antibodies. VoxPress COVID-19 neutralising antibody is a lateral flow test that detects IgG antibodies to spike protein of the SARS-CoV-2 virus, from a small finger prick of blood in only 15 minutes.VoxPress COVID-19 is affordable and comes with a rapid turnaround time (15 minutes), high specificity (94 per cent) and sensitivity (100 per cent) and long shelf life of 24 months. It has advantages over the other methods in many ways such as no specific laboratory requirements, no need for specific training of the analyst along with field applicability, easy scalability and mass screening possibility. ]]> https://biospectrumindia.com/news/97/20616/auriga-research-expedites-covid-19-testing-at-bengaluru-airport-.html https://biospectrumindia.com/news/97/20616/auriga-research-expedites-covid-19-testing-at-bengaluru-airport-.html Thu, 10 Feb 2022 00:00:00 +0530 Auriga Research, a NABL accredited testing lab in India, has upgraded its team strength to 250+ members to support 24x7x365 COVID-19 testing at the Kempegowda International Airport in Bengaluru. Operating throughout the pandemic, Auriga has, till date, facilitated hundreds of thousands of tests for both arrivals and departures, at the airport. The Rapid-PCR test method using the globally acclaimed Abbott ID delivers results in less than 15 minutes with 95% accuracy and is priced at Rs 3000. Auriga also offers gold standard PerkinElmer High Throughput RT-PCR tests that deliver results in 5-6 hours, priced at Rs 500, and Rapid Antigen tests that deliver results in 40 minutes, priced at Rs 400, in compliance with the pricing by the Government of Karnataka. Early in the pandemic, Auriga set up its real-time PCR lab at the airport with an investment of more than Rs 2 crores and was the first to offer Abbott ID Now facilities. After the resumption of flights, the situation worsened, and Auriga made a further investment of Rs 50 lakhs to add multiple PCR machines and extractors, including increasing staff strength to manage the footfall smoothly, in a time-bound manner. ]]> https://biospectrumindia.com/news/97/20604/west-partners-with-iit-palakkad-for-medtech-research.html https://biospectrumindia.com/news/97/20604/west-partners-with-iit-palakkad-for-medtech-research.html Wed, 09 Feb 2022 14:45:00 +0530 West Pharmaceutical Services, a global leader in innovative solutions for injectable drug and healthcare products, has announced its partnership with TECHIN – a Technology Innovation Foundation of IIT Palakkad which focuses on assisting innovation and incubation for budding entrepreneurs, to build a Medtech Research Center of Excellence.    The aim of building a distinctive Medtech Research Center of Excellence is to enable access to healthcare and medical technology by developing an ecosystem of academia, hospitals and the industry to promote local entrepreneurship. West’s medical expertise with IIT’s unique incubation model will be combined to advance research and development in medical technology.   West will work with IIT Palakkad’s TECHIN in the area of medical technology. The engagement will be carried out by West’s Digital Technology Center (DTC) in Bengaluru which will be directly working with TECHIN’s team throughout this partnership. West will be providing a noncommercial version of its ‘medical device connectivity platform’ to support the development of connected med-tech equipment. Additionally, West will mentor and may fund startups through the MedTech Research Center of Excellence.     ]]> https://biospectrumindia.com/news/97/20598/tata-mds-upgraded-omisure-detects-all-omicron-variants.html https://biospectrumindia.com/news/97/20598/tata-mds-upgraded-omisure-detects-all-omicron-variants.html Wed, 09 Feb 2022 09:15:00 +0530 TATA Medical and Diagnostics (TATA MD) has announced that its OmiSure RT-PCR test has been upgraded to detect the new BA.2 sub-lineages of Omicron. In an evaluation carried out by ICMR and the Virus Research & Diagnostics Laboratory, Kasturba Hospital for Infectious Diseases, Mumbai, the upgraded OmiSure successfully detected BA.1, BA.1.1, and BA.2 sub-lineages of Omicron.   With this, the OmiSure RT-PCR test kit is now capable of detecting all the sub-lineages of Omicron prolific in India at present.   TATA MD OmiSure RT-PCR test was developed in partnership with ICMR and detected Omicron with 100 per cent concordance, as per the ICMR report.    OmiSure RT-PCR test decreases the load on sequencing; allows healthcare authorities to assess the evolution of variants and take timely action to control spread. Additionally, samples negative for Omicron on the OmiSure test can be prioritised for sequencing as the chances of detecting other variants and newer mutations are higher in these samples. ]]> https://biospectrumindia.com/news/97/20546/mylab-launches-worlds-first-high-throughput-poc-testing-solution-for-covid-19.html https://biospectrumindia.com/news/97/20546/mylab-launches-worlds-first-high-throughput-poc-testing-solution-for-covid-19.html Wed, 02 Feb 2022 15:25:00 +0530 Pune-based startup Mylab Discovery Solutions has announced the approval and launch of CoviSwift. It is the first point-of-care (POC) testing solution that can be used at small labs, in-hospital labs, airports, villages and allow gold standard testing at high throughputs anywhere.   The solution comprises the CoviSwift assay and Compact-Q machines which process 16 samples within 40 minutes. This is approximately 4 times faster than the traditional method of RT-PCR testing while maintaining the gold standard accuracy.    Technically, CoviSwift is driven by RT-PCR gold standard technology. The in-field accuracy is nowhere close to RT-PCR gold standard. This will ensure that now ports of entry have a reliable solution of testing and limit the spread of next variants in the future from other countries or within the country. The test is expected to be available in the market in early February.   ]]> https://biospectrumindia.com/news/97/20493/iit-jodhpur-develops-automated-ai-solution-for-covid-19-screening-from-chest-x-rays.html https://biospectrumindia.com/news/97/20493/iit-jodhpur-develops-automated-ai-solution-for-covid-19-screening-from-chest-x-rays.html Fri, 28 Jan 2022 16:20:00 +0530 Researchers at the Indian Institute of Technology (IIT) Jodhpur have developed an explainable Artificial Intelligence (AI) solution for predicting COVID-19 from chest X-rays (CXR).   The researchers have proposed a deep learning-based algorithm called COMiT-Net, which learns the abnormalities present in the chest X-Ray images to differentiate between a COVID-19 affected lung and a non-COVID affected lung. The developed AI algorithm not only predicts whether the CXR has COVID-19 pneumonia or not, but it is also capable of identifying the infected regions in the lungs, thus making them explainable.   The proposed study can visually showcase the region which is infected and the AI solution used in this research is explainable from both algorithmic and medical points of view.   A research paper on this project has been published in the journal 'Pattern Recognition (Volume 122),'. The research is part of the RAKSHAK project under NM-CPS DST and iHuB Drishti at IIT Jodhpur.  ]]> https://biospectrumindia.com/news/97/20468/roche-launches-covid-19-at-home-test-kit-in-india.html https://biospectrumindia.com/news/97/20468/roche-launches-covid-19-at-home-test-kit-in-india.html Thu, 27 Jan 2022 12:25:00 +0530 Roche Diagnostics India has announced its latest diagnostic solution – the COVID-19 At-Home Test. The over-the-counter test is intended to be used for the detection of SARS CoV-2 infection in individuals with symptoms suggestive of COVID-19 and is approved by ICMR. COVID-19 At-Home Test can successfully detect SARS-CoV-2 virus including the Omicron variant.    Individuals can perform the self-test at home without special training or the supervision of a healthcare worker and expect results in 15 minutes. The test collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and more comfortable sampling procedure. The test will be available in e-pharmacies and local pharmacies and requires no prescription.   The self-test kit includes a test cassette, a sterile swab, a tube with liquid and nozzle cap, along with a step-by-step self-test guide and QR code to access the instruction video. Users will have to download the ‘My Covid-M’ app using the QR code which will help them read and interpret the test results and also update the results to the ICMR database.    The tube with liquid neutralises the SARS-CoV-2 virus. The test kit will also include a biomedical waste disposal bag for the kit following testing.  ]]> https://biospectrumindia.com/news/97/20460/srl-diagnostics-gets-integrated-with-ayushman-bharat-digital-mission.html https://biospectrumindia.com/news/97/20460/srl-diagnostics-gets-integrated-with-ayushman-bharat-digital-mission.html Tue, 25 Jan 2022 00:00:00 +0530 SRL Diagnostics is the only lab chain to have developed a proprietary Central Laboratory Information Management System. SRL’s CLIMS is now integrated with Ayushman Bharat Digital Mission (ABDM) for the following capabilities- ABHA number Capture & Verification for seamless patient registration. ABDM Health Id is re-coined now as “Ayushman Bharat Health Account” Number. Building Health Information Provider services (HIP) to share health records via Personal Health Records (PHR) app Developing Health Information User (HIU) services to provide view of patient’s medical history to authorized healthcare workers with complete consent. Speaking on the announcement, Anand. K, Chief Executive Officer, SRL Diagnostics said “We are thrilled to be now integrated with ABDM. SRL has been at the forefront of harnessing the power of information and technology to enable superior patient care and convenience. It is our privilege to be a part of the national digital health ecosystem in India.” The National Health Authority awarded SRL Diagnostics with ‘ABDM Integration Completion Certificate’ along with ‘ABDM Integrated Logo’ for successful integration of SRL CLIMS with ABDM. This is a step towards achieving common goal to provided effective healthcare to citizens by enabling innovation and digitally transforming our country’s healthcare eco-system.   ]]> https://biospectrumindia.com/news/97/20412/govt-unveils-mobile-covid-19-testing-facility-for-northeast.html https://biospectrumindia.com/news/97/20412/govt-unveils-mobile-covid-19-testing-facility-for-northeast.html Thu, 20 Jan 2022 00:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh has launched Mobile COVID-19 testing facility for Northeast, beginning with Mizoram from where the State Chief Minister Pu Zoramthanga joined the launching ceremony online. The first of its kind Mobile Diagnostic Laboratory (I-LAB) is capable of performing both RT-PCR and ELISA. Dr Jitendra Singh said, the lab developed with the support from the Department of Biotechnology, Govt of India, is meant to provide COVID-19 testing access to rural and remote parts of North Eastern Region of India. He said, the unit has bio-safety facility and is capable of performing both RT-PCR and ELISA tests and this facility can also be utilised for testing of other infectious diseases like TB, HIV, and therefore will remain relevant even in post-COVID-19 times. Dr Jitendra Singh called for linking the I-LAB with tele-consultation facility in accordance with disease profile of the population of the North-Eastern region. He informed that tests like Mammography and Vision-testing can be added with the mobile laboratory and will prove hugely beneficial to the people of the region. Dr Rajesh Gokhale, Secretary DBT said that Mobile Diagnostic Laboratory (I-LAB) will remain relevant round the year even after COVID-19 for testing of infectious diseases like Tuberculosis, HIV. ]]> https://biospectrumindia.com/news/97/20396/icmr-approves-krivida-novus-rt-pcr-test-that-detects-omicron-in-45-mins.html https://biospectrumindia.com/news/97/20396/icmr-approves-krivida-novus-rt-pcr-test-that-detects-omicron-in-45-mins.html Wed, 19 Jan 2022 17:20:00 +0530 KRIVIDA Novus RT-PCR kit, developed by Chennai-based KRIYA Medical technologies in collaboration with ImmuGenix Bioscience, has received approval from ICMR (Indian Council of Medical Research). The kit detects the SARS-CoV-2 virus and also differentiates the Omicron variant from Delta and other variants. The test takes just about 45 minutes to detect the infection and determine the variant.    The kit detects SARS-CoV-2 using five different gene targets and it has a variant specific S gene probe for the newly emerged Omicron. KRIVIDA Novus picks up all the sub-lineages of Omicron, such as, BA.1, BA.2 and BA.3. The test is most suitable for entry point screening at airports    KRIVIDA Novus will be produced at KRIYA’s state-of-the-art manufacturing facility in Oragadam in Chennai. The company currently has a manufacturing capacity of 5 million kits and plans to increase it to 10 million within a week depending on the demand. The test is priced competitively, and it will soon be commercially available across the country.      ]]> https://biospectrumindia.com/news/97/20380/medall-plans-to-open-300-400-centres-in-2022-in-south-india.html https://biospectrumindia.com/news/97/20380/medall-plans-to-open-300-400-centres-in-2022-in-south-india.html Tue, 18 Jan 2022 16:10:00 +0530 One of South India’s largest chain of medical diagnostic services providers, Medall has announced its plans to expand across South India. Apart from penetrating deeper into Tamil Nadu into Tier II and III cities, Medall will also be expanding into other South Indian states, viz, Karnataka, Andhra Pradesh, Telangana and Kerala. Positioned as a franchisee model, the centres will be in multiple formats consisting of collection centres, mini wellness centres, full-service centres, lab collection centres and Medall Care Centres. Medall plans to open about 300 – 400 centres across South India during the year. ]]> https://biospectrumindia.com/news/97/20361/cosara-diagnostics-bags-cdsco-clearance-for-high-risk-hpv-multiplex-test.html https://biospectrumindia.com/news/97/20361/cosara-diagnostics-bags-cdsco-clearance-for-high-risk-hpv-multiplex-test.html Fri, 14 Jan 2022 17:15:00 +0530 Co-Diagnostics, a molecular diagnostics company, has announced that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell its SARAGENE Human Papillomavirus High-Risk (HPV-HR) Real-Time PCR test as an in vitro diagnostic (IVD).   CoSara's new multiplex test, the 12th CoSara assay to receive CDSCO approval, is built on the company's patented CoPrimer technology and designed to detect and differentiate between HPV genotypes 16 and 18, while simultaneously detecting high-risk carcinogenic HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.   CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C, HPV (types 16 and 18 only), two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, and a Flu A/Flu B/COVID-19 (ABC) multiplex test, all designed using the Company's patented CoPrimer technology and cleared to be manufactured and sold as IVDs in the Indian market.   ]]> https://biospectrumindia.com/news/97/20353/hyd-based-biogenex-develops-rt-pcr-kit-for-all-covid-19-variants.html https://biospectrumindia.com/news/97/20353/hyd-based-biogenex-develops-rt-pcr-kit-for-all-covid-19-variants.html Thu, 13 Jan 2022 17:35:00 +0530 Hyderabad-based BioGenex Life Sciences has developed a RT-PCR kit for COVID-19 diagnosis, which detects COVID-19 caused by SARS COV 2 variants including 'OMICRON' plus other variants.   The NIB, Noida, an ICMR designated lab, examined the performance of this kit and found that it performed with 100% accuracy which means no false negatives or positives, which will significantly control the pandemic through accurate diagnosis. The kit detects the Omicron variant in half the time than the standard RT-PCR test.   The TRIPLEX COVID-19 RT-PCR Direct is a real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 directly from the upper respiratory swab, nasopharyngeal or oropharyngeal swabs, collected in preservative media, (VTM/UTM), pH 7.2-7.4 to provide the molecular diagnostic basis for infected patients.   The test analyses samples in VTM directly without the need for RNA extraction step. It helps scientists for rapid tracking of disease prevalence and aid in treatment insight (e.g. hospital beds, oxygen ventilators and expensive medications) for healthcare systems in making appropriate measures to combat COVID-19.   ]]> https://biospectrumindia.com/news/97/20344/wellness-diagnostics-automates-central-lab-with-mindrays-sal-9000-modular-system.html https://biospectrumindia.com/news/97/20344/wellness-diagnostics-automates-central-lab-with-mindrays-sal-9000-modular-system.html Wed, 12 Jan 2022 17:25:00 +0530 Wellness Diagnostics, providing its testing services across North India, has automated its central laboratory with Mindray Medical India’s Serum Automation Line Series (SAL) 9000 modular system.   Wellness Diagnostics currently has its reference laboratory equipped with two units of Mindray’s CL-1000i – Chemiluminescence Analyzer, one unit of BS-380 – Biochemistry automated a, one unit of BS240 pro, one unit of BC-6000, and one unit of SAL 9000.   The SAL 9000 Modular System installed at Wellness Diagnostics delivers a high throughput of chemistry and immune-assay testing by integrating the Mindray BS-2000 Chemistry Analyzer and CL-6000i Chemi-luminescence Immunoassay Analyzer, and new Sample Processing Line (SPL) 2000. With patented automatic serum analysis design, the SAL 9000 not only helps in optimising the management of lab space and manpower but also offers highly reliable test results.   Mindray Serum Automation Line Series (SAL) 9000 is a high-functioning, integrated system that connects the clinical chemistry analyzers seamlessly with the chemi-luminescence immunology analyzers. Delivering fast and reliable results of both clinical chemistry and immunology tests on one platform, the system helps optimize the laboratory workflow and achieve maximum efficiency at Wellness Diagnostics.     ]]> https://biospectrumindia.com/news/97/20333/intuitive-unveils-indias-first-remote-surgical-case-observation-technology.html https://biospectrumindia.com/news/97/20333/intuitive-unveils-indias-first-remote-surgical-case-observation-technology.html Tue, 11 Jan 2022 13:45:00 +0530 Intuitive India has launched India's first remote surgical case observation technology, ‘Intuitive Telepresence’ (ITP). The technology enables surgeons to learn from expert surgeons without the need for travel or time away from their busy practice.     The ITP uses proprietary technology that enables the real-time exchange of audio and video between the remote observer and the operating surgeon. Through this, observers can be virtually present in the operating room (OR) where a procedure with a da Vinci system is being performed.   ITP technology is HIPPA (The Health Insurance Portability and Accountability Act) compliant which provides a secure platform for remote learning on da Vinci Robotic platform.   With the increased adoption of virtual ways of working since the spread of COVID-19, Intuitive has, with the ITP, reimagined continuous learning for surgeons by providing this seamless and secure platform to help bring learning to the surgeons—rather than asking them always travel for advanced training.    Intuitive has been running programmes such as the Intuitive Robotic Onboarding Programme and Education (I-ROPE) and the Roving Robot Programme in a continued effort to support strong robotics programs throughout India. ]]> https://biospectrumindia.com/news/97/20330/jj-ties-up-with-microsoft.html https://biospectrumindia.com/news/97/20330/jj-ties-up-with-microsoft.html Tue, 11 Jan 2022 11:45:00 +0530 The Johnson & Johnson Medical Devices Companies (JJMDC) will collaborate with Microsoft to further enable and expand JJMDC's secure and compliant digital surgery ecosystem. The Microsoft Cloud will help JJMDC realise its vision of driving innovation that advances skills, improve workflow, and enhances surgical decision making for a better overall customer experience and improved patient and economic outcomes.   As part of the strategic partnership, Microsoft will serve as JJMDC's preferred cloud provider for the company's digital surgery solutions and help JJMDC build out its digital surgery platform and internet of things (IoT) device connectivity. By harnessing the power of the Microsoft Cloud, including Azure, artificial intelligence (AI), and machine learning, Microsoft 365 and Dynamics 365, the companies expect to work together to deliver innovation across the following areas: Innovating to improve patient outcomes through artificial intelligence, machine learning and data insights. Increasing JJMDC device connectivity, insights and intelligence using Azure IoT and Edge Computing technologies. Increasing the pace of digital innovation and transformation across the JJMDC digital surgery ecosystem using Azure capabilities and services.   ]]> https://biospectrumindia.com/news/97/20326/innaccel-tech-wins-wbg-ces-global-womens-healthtech-awards-at-ces-2022.html https://biospectrumindia.com/news/97/20326/innaccel-tech-wins-wbg-ces-global-womens-healthtech-awards-at-ces-2022.html Mon, 10 Jan 2022 16:45:00 +0530 InnAccel Technologies, a start-up known to develop unique novel globally certified medical devices in India has won the WBS-CES Global Women’s HealthTech award at the prestigious Consumer Electronics Show 2022. InnAccel Technologies has been recognized for its pregnancy monitoring product - Fetal Lite.    Fetal Lite is a next-generation, AI-powered, pregnancy monitoring and labour management technology. It has been designed to increase access to adequate and timely pregnancy and labour monitoring at home and in clinical settings across cities and remote rural areas with limited infrastructure. Fetal Lite, based on next-gen ECG signal processing, is more accurate, reliable, and easier to use compared to conventional Doppler-based devices. Fetal Lite will help in reducing the 300,000 annual intrapartum deaths that occur every year in India, due to inadequate monitoring with current technologies.    Through a joint global programme, IFC of the World Bank Group and CES, owned and produced by the Consumer Technology Association (CTA), aim to identify and celebrate innovative technologies that can address gaps in women’s health care and safety in emerging markets. Over 70 companies from across the globe applied for these awards and Fetal Lite emerged as a winner after a rigorous selection process.    ]]> https://biospectrumindia.com/news/97/20324/tata-md-bags-order-from-odisha-govt-for-omisure-rt-pcr-tests.html https://biospectrumindia.com/news/97/20324/tata-md-bags-order-from-odisha-govt-for-omisure-rt-pcr-tests.html Mon, 10 Jan 2022 13:05:00 +0530 TATA Medical and Diagnostics (TATA MD) has received an order for 5 lakh tests from Odisha State Medical Corporation Limited (OSMCL). The Government of Odisha is the first state in the country to order the TATA MD CHECK OmiSure RT- PCR tests developed in partnership with ICMR for detection of the Omicron variant of COVID.    TATA MD CHECK RT-PCR OmiSure is the only test approved by the ICMR for RT-PCR detection of the Omicron variant. It targets 3 gene with a single tube, fully multiplexed assay in a unique design that identifies simultaneous S-gene Target Failure (SGTF) and S-Gene Mutation Amplification (SGMA).   Girish Krishnamurthy, CEO and MD, TATA Medical and Diagnostics said, “OmiSure is the only test that can specifically detect the Omicron variant at the point of testing. We would like to thank the Government of Odisha, the first state in the country that has decided to use TATA MD OmiSure for COVID testing and would provide all necessary support.” ]]> https://biospectrumindia.com/news/97/20319/lmd-conducts-successfull-trial-of-app-based-blood-pressure-monitors.html https://biospectrumindia.com/news/97/20319/lmd-conducts-successfull-trial-of-app-based-blood-pressure-monitors.html Fri, 07 Jan 2022 17:15:00 +0530 Leman Micro Devices’ e-Checkup system has completed a world-first clinical trial and proven it is the only completely cuffless and calibration-free sensor and app capable of measuring blood pressure with the accuracy demanded for medical use.   e-Checkup and its small V-Sensor, which costs only a few dollars, have been developed and industrialised by LMD to be built into a mobile phone or into a wearable or a pocket monitor connected to a phone by Bluetooth and the app on the phone analyses the measurements from the sensor to deliver a clinically-accurate personal blood pressure measurement in under 60 seconds.   The clinical trial was conducted by SVS Medical College in Mahabubnagar. The trial adhered to the internationally recognised ISO 81060-2 standard that sets the requirements for automatic blood pressure monitors used by hospitals, doctors and consumers. It found that e-Checkup fully complied with all the criteria of the standard.   Dr K Saumya, Principal Investigator for the trial, said “This device will be a real life-saver in India. It is small and affordable and will alert people to the need to consult a doctor about their blood pressure before they have symptoms and before it gives rise to awful consequences such as stroke, kidney damage, heart attack or blindness." ]]> https://biospectrumindia.com/news/97/20311/johari-digital-healthcare-opens-coe-at-iit-jodhpur-technology-park-.html https://biospectrumindia.com/news/97/20311/johari-digital-healthcare-opens-coe-at-iit-jodhpur-technology-park-.html Thu, 06 Jan 2022 14:15:00 +0530 Jodhpur-based medtech firm Johari Digital Healthcare has launched the Johari Centre of Excellence (CoE) at the Indian Institute of Technology (IIT) Jodhpur Technology Park.   With the healthcare market embracing contemporary technologies of Artificial intelligence and data-based remote healthcare, this Centre of Excellence at IIT Jodhpur will establish vital synergy between academia and industry for advanced healthcare technologies.   It will be a unique opportunity to develop accessible, affordable, and quality healthcare devices at a higher pace and scale to meet the global demand.   Prof. Santanu Chaudhury, Director, IIT Jodhpur, said, “This Centre of Excellence will lead to the development of products which have originated from India, the entire IP as well as the manufacturing capability will also be with India. For a new IIT like IIT Jodhpur, this alliance with a global player like Johari in Jodhpur has huge value. This will nucleate a medtech industrial ecosystem in the country.”     ]]> https://biospectrumindia.com/news/97/20302/iit-kanpur-puts-focus-on-developing-worlds-most-advanced-artificial-heart.html https://biospectrumindia.com/news/97/20302/iit-kanpur-puts-focus-on-developing-worlds-most-advanced-artificial-heart.html Wed, 05 Jan 2022 12:45:00 +0530 The School of Medical Research and Technology (SMRT), at the Indian Institute of Technology (IIT) Kanpur, has announced the launch of Hridyantra, a grand challenge-based programme to develop the world’s most advanced Artificial Heart or a Left Ventricular Assist device (LVAD).   The programme, in collaboration with the nation’s leading hospitals, would promote the vision of Made in India for the world.    A team of innovators with relevant experience will be selected under the mentorship of a task force composed of industry experts. The challenge to develop India’s first LVAD system will be open to basic sciences, medical and engineering graduates or graduates of any stream with relevant experience.   Selected candidates will receive a fellowship and a milestone based ownership in the commercial entity once the LVAD is successfully commercialised and launched.   The SMRT, IIT Kanpur has created a task force that includes engineering faculty members from IIT Kanpur, industry experts from the US, and clinical experts from Narayana Health, All India Institute of Medical Sciences-Delhi (AIIMS Delhi), Apollo, Fortis Healthcare, Medanta, KIMS, and UN Mehta Heart Institute to handhold the selected fellows on developing the Artificial Heart.    Upon completing their clinical immersion, the fellows will move to IIT Kanpur to begin the product development process under the project. The minimum eligibility criteria for candidates is a bachelor’s degree in any relevant basic sciences, engineering or medical sciences discipline or a graduate in any stream with related experience. Candidates should be team players, with a penchant for creativity and problem-solving.     ]]> https://biospectrumindia.com/news/97/20263/translumina-to-set-up-asias-largest-heart-valve-manufacturing-facility-at-amtz-vizag.html https://biospectrumindia.com/news/97/20263/translumina-to-set-up-asias-largest-heart-valve-manufacturing-facility-at-amtz-vizag.html Tue, 28 Dec 2021 00:00:00 +0530 Translumina, based in India and Germany, has performed the foundation stone laying ceremony of Asia's Largest Heart Valve manufacturing facility at Andhra Pradesh Medtech Zone (AMTZ) in Vizag. "We have partnered with some of the best institutions and physicians around the world to create next-generation heart valve technologies to offer better clinical outcomes at an affordable cost for all kinds of valve disorders." said Gurmit Singh Chugh, MD and Co-founder, Translumina. "We plan to complete the facility by December 2022 with more than 100,000 square feet of manufacturing space with the state-of-the-art equipment and infrastructure," said Punita Sharma Arora, Co-Founder, Translumina. Heart valve disorders which traditionally were treated by an open-heart Surgery, are prevalent significantly worldwide. However, in the last few years, Transcatheter Heart valve Implantation (using a catheter without opening the heart) has made the procedure simple, safe and effective with a minimally invasive approach. However, the prohibitive cost of the transcatheter valves, along with niche indications, have made therapy limited to very few patients.         ]]> https://biospectrumindia.com/news/97/20257/raphacure-partners-with-zeebon-to-foray-into-north-east-market.html https://biospectrumindia.com/news/97/20257/raphacure-partners-with-zeebon-to-foray-into-north-east-market.html Mon, 27 Dec 2021 00:00:00 +0530 Bengaluru-based digital healthcare services provider, RaphaCure has entered into a strategic collaboration with North East India’s largest diagnostics services provider ‘Zeebon’ as the company forays into the burgeoning healthcare market in this region. With this strategic partnership, RaphaCure & Zeebon will leverage their innovative healthtech solutions to provide qualitative and affordable healthcare for people living even in the remotest areas of this region. The entry of RaphaCure is expected to bring in a paradigm shift in how healthcare is delivered in North-Eastern states that are geographically located in difficult and hilly terrain. Apart from introducing its cutting-edge telemedicine platforms, RaphaCure will also bring in revolutionary changes in the wellness space in North East India. RaphaCure is currently building a team of professionals in its mission to provide healthcare services in the most remote areas of India. ]]> https://biospectrumindia.com/news/97/20248/manipal-hospital-delhi-launches-radionuclide-therapy.html https://biospectrumindia.com/news/97/20248/manipal-hospital-delhi-launches-radionuclide-therapy.html Fri, 24 Dec 2021 00:00:00 +0530 With an aim to provide comprehensive cancer care, Manipal Hospital Delhi has recently launched the Radionuclide Therapy. With the introduction of radionuclide therapy (I-131), Manipal Hospital Delhi now boasts of cutting-edge diagnostic modalities and state-of-the-art treatment options for cancer care, making it Dwarka's first Comprehensive Cancer Care Centre. Radionuclide therapy utilizes radioactive medicines for treatment of various cancers and benign conditions. This facility will be a significant addition to the existing oncological services, making it a holistic oncology facility. What makes it more unique is that with the addition of Radionuclide therapy, the entire spectrum of advanced cancer therapies will be served under one roof. In addition to this Manipal Hospital Delhi will be able to treat all possible forms of cancer.   ]]> https://biospectrumindia.com/news/97/20238/tata-md-check-express-rt-pcr-solutions-to-boost-testing-for-omicron-variant.html https://biospectrumindia.com/news/97/20238/tata-md-check-express-rt-pcr-solutions-to-boost-testing-for-omicron-variant.html Wed, 22 Dec 2021 00:00:00 +0530 With studies in India pointing to a possible surge in cases in February next year, there is expected to be a multifold increase in demand for RT-PCR COVID-19 tests that are economical and give fast results. To meet this challenge, Tata MD has indigenously developed the COVID-19 testing solutions that will significantly boost India’s testing capacity. Tata MD COVID Express RT PCR solution consists of: Tata MD CHECK XF, a 3-Gene RT-PCR kit that is RNA extraction free and uses fast amplification protocol combined with a portable and fast qPCR analyzer. The solution has a processing time of just one hour. And can process 30 samples per batch per machine. The kit is approved by ICMR with 95%+ sensitivity and 100% specificity. Tata MD CHECK RT-PCR Fast 3Gene is a 3-Gene RT-PCR kit that uses fast amplification protocol and hence has a processing time of 90 minutes. And can process 90 samples per batch per machine. The kit can be used in existing qPCR instruments. It is approved by ICMR with 100% Sensitivity and 100% Specificity. Girish Krishnamurthy, CEO, Tata Medical & Diagnostics Ltd. said, “These express testing solutions can be applied in multiple areas where quick, high volume, and reliable testing is required such as airports and events”    ]]> https://biospectrumindia.com/news/97/20211/sai-life-sciences-commences-recruitment-of-100-scientists-for-drug-discovery-biz.html https://biospectrumindia.com/news/97/20211/sai-life-sciences-commences-recruitment-of-100-scientists-for-drug-discovery-biz.html Thu, 16 Dec 2021 17:05:00 +0530 Sai Life Sciences has commenced recruitment for 100+ scientific positions across medicinal chemistry and biology to bolster the company's plans of achieving scale, scope and speed in its discovery business. All the positions will be based at the company's Integrated Research & Development campus in Hyderabad.   The present recruitment drive is aimed at increasing capacity in India to meet the growing demand for the company's discovery services. In recent months, the company has doubled the headcount at both; its Boston and Manchester sites.   Sai Life Sciences is currently at the halfway mark of its organizational transformative initiative, Sai Nxt. Backed by an investment commitment of $150 million and envisaged as a four-year programme from 2019 to 2023, it aims to drive transformation across three core areas: People and culture, Processes & automation and Infrastructure and scientific capabilities. So far, the company has already invested $100M, enabling an upsurge in the company's capabilities, augmenting its standing as a global CRO-CDMO offering cutting edge solutions to innovator pharma and biotech companies.   The company is looking to onboard top-notch global scientific talent with M.Sc./ Ph D / Post Doctorates in synthetic organic/analytical chemistry from reputed academic institutions, and experience in global pharma R&D of up to 20 years, for various roles across levels in medicinal chemistry, biology, DMPK and toxicology.    ]]> https://biospectrumindia.com/news/97/20212/medical-devices-park-in-telangana-achieves-new-milestone.html https://biospectrumindia.com/news/97/20212/medical-devices-park-in-telangana-achieves-new-milestone.html Thu, 16 Dec 2021 00:00:00 +0530 Kalvakuntla Taraka Rama Rao, Minister for Municipal Administration & Urban Development, Industries & Commerce, and Information Technology of Telangana inaugurated 7 factories in Medical Devices Park in Sultanpur, Sangareddy. The seven companies are Promea Therapeutics, Huwel Life Sciences, Akriti Oculoplasty, Arka Engineers (Medical), SVP Techno Engineers, Elvikon and Rees Medilife. While Akriti is one of the first companies in India to manufacture end to end eyewear frames, reading glasses, safety glasses, diagnostics products, & many other surgical implants, Arka Medical manufactures Dental & Maxillofacial implants, Prosthetics and other accessories and is currently rendering novel designs in Dental Implants. On the other hand, Promea Therapeutics is a diagnostics and medical devices manufacturing company specializing in immunodiagnostics, molecular diagnostics, and large volume parenterals. “Since its launch, the Sultanpur medical device park has 50 companies setting up their manufacturing and R&D units with an overall investment of Rs 1424 Crores and total employment of around 7000 direct jobs. We aim to make this park as not just a global factory for the world but a global medtech innovation ecosystem,” Kalvakuntla Taraka Rama Rao said. ]]> https://biospectrumindia.com/news/97/20197/aragen-life-sciences-acquires-pune-based-cro-intox.html https://biospectrumindia.com/news/97/20197/aragen-life-sciences-acquires-pune-based-cro-intox.html Wed, 15 Dec 2021 14:35:00 +0530 Hyderabad-based Aragen Life Sciences has signed a definitive agreement to acquire Pune-based Intox. The acquisition will expand Aragen’s end-to-end integrated discovery and development platform for the pharmaceuticals, biotechnology, animal health and agrochemicals industries.   It will enable Aragen to conduct safety assessment studies from a Good Laboratory Practice (GLP)-certified facility for submission to regulatory agencies such as the United States Food and Drug Administration (USFDA), the United States Environment Protection Agency (USEPA), the European Medicines Agency (EMA), and others globally.   Intox is a reputed GLP certified pre-clinical contract research organization (CRO) with its test facilities in Pune. It has conducted more than 15,000 GLP studies for global clients which include large and mid-sized customers across pharmaceuticals, biopharmaceuticals, plant protection, nutraceuticals, and medical devices.   The acquisition will also expand Aragen’s geographical footprint in India. Aragen currently has research and manufacturing facilities at Hyderabad, Bengaluru and Visakhapatnam in India and a biologics facility in California, USA. ]]> https://biospectrumindia.com/news/97/20196/roche-launches-infectious-disease-tests-on-cobas-5800-system.html https://biospectrumindia.com/news/97/20196/roche-launches-infectious-disease-tests-on-cobas-5800-system.html Wed, 15 Dec 2021 14:25:00 +0530 Roche has launched the first infectious disease tests on the cobas 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark. These include cobas HIV-1, cobas HBV, cobas HCV, cobas HIV-1/HIV-2 Qualitative, and the cobas omni Utility Channel kit.   These launches expand the Roche Molecular portfolio offering by providing standardised performance and efficiencies across low, medium and high volume molecular laboratory testing needs.   The cobas 5800 System, a compact new addition to the Roche Diagnostics Molecular Work Area, is built upon the innovation of the cobas 6800 and 8800 Systems, making molecular testing accessible to more patients around the world.   The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems. Roche is pursuing CE approval for continued menu expansion on the cobas 5800 System, including cobas SARS-CoV-2, through early-to-mid 2022. Roche anticipates tests to be available beyond CE markets in additional countries in 2022. ]]> https://biospectrumindia.com/news/97/20193/most-national-diagnostic-players-to-deliver-double-digit-revenue-growth-in-fy2022-icra.html https://biospectrumindia.com/news/97/20193/most-national-diagnostic-players-to-deliver-double-digit-revenue-growth-in-fy2022-icra.html Wed, 15 Dec 2021 11:10:00 +0530 The Indian diagnostics industry witnessed healthy revenue growth in FY2021 with COVID-19 related tests contributing to ~20-25per cent revenues, in turn supporting profit margins. During H1 FY2022, ICRA’s sample set witnessed volume growth of 74 per cent aided by a low base and spike in COVID-19 and allied tests in the second wave. This was in line with the active cases in India that touched an all-time high in May 2021, peaking at more than 4x the first wave peak. Despite regulated pricing on COVID-19 tests, a better volume mix led to improved realisation in H1 FY2022. Overall, the revenues of the sample set grew by 55 per cent Y-o-Y in H1 FY2022; this is expected to moderate in H2 FY2022 on account of the festive season and relatively lower pent-up demand.    Says Mythri Macherla, Assistant Vice President and Sector Head, ICRA, “We expect revenue growth of its sample set to be 20-25 per cent in FY2022. In line with sequential improvement expected in non-Covid revenues and consolidation of regional chains, revenue growth is estimated at ~8-10 per cent in FY2023. Recent trends such as a focus on digital brand building, improved offerings in bundled medical packages, changing consumer mindset towards organised players are likely to support demand traction for national diagnostic chains going forward.”    The operating profitability margins (OPM) of the sample set improved to 32 per cent in H1 FY2022 (as compared to 23 per cent in H1 FY2021 and 30 per cent in Q4 FY2021) given a lower base, operating leverage benefits from increased realisations and stabilised raw material prices. ICRA expects the OPM levels to improve sharply to 30-32 per cent in FY2022 (as against 27.2 per cent in FY2021). The same is expected to stabilize in the range of ~29-30 per cent during FY2023 due to the sector’s focus on volume growth against the prevailing pricing pressures.    AddsMacherla, “With pricing pressures weighing in on the organized players, realization and EBIDTA levels are expected to stabilise going forward. That said, the shift of customer demand from unorganised to organised chains and the increasing trend of home collections shall positively impact the volume mix and support realisations. Geographical diversification by way of acquisition of regional and smaller diagnostic chains shall result in consolidation and generate synergy benefits in the medium term. Expansion of lab and collection centre network via franchisee model will aid asset-light growth prospects. With news around the Omicron variant, testing is expected to increase in December 2021 due to travel norms in certain states. That said, increasing pace of vaccinations could mitigate the spread of the new variant and reduce the level of COVID-19 related tests in the medium term.” ]]> https://biospectrumindia.com/news/97/20190/iit-delhi-develops-rt-pcr-based-assay-for-identification-of-omicron.html https://biospectrumindia.com/news/97/20190/iit-delhi-develops-rt-pcr-based-assay-for-identification-of-omicron.html Tue, 14 Dec 2021 18:15:00 +0530 Researchers at the Indian Institute of Technology (IIT) Delhi’s Kusuma School of Biological Sciences have developed an RT-PCR based assay for the specific detection of the Omicron (B.1.1.529.1) variant of SARS-CoV-2.The assay is based on detecting specific mutations, which are present in the Omicron variant and absent in other currently circulating variants of SARS-CoV-2. Primer sets targeting these unique mutations in the S gene were designed for the specific amplification of either the Omicron variant or other currently circulating variants of SARS-CoV-2 and tested using real-time PCR. Using synthetic DNA fragments, the assays were optimised to distinguish the wild-type from the Omicron variant in a dynamic range from 10 million to <100 copies /reaction. Currently, the identification or screening for omicron is done worldwide using next-generation sequencing-based methods, which require over 3 days. By using this RT-PCR based assay, it will be possible to test for the presence of the Omicron variant within 90 minutes. This can be used as a rapid screening assay for the identification and isolation of individuals with Omicron variants. IIT Delhi has filed an Indian patent application for the same and is in the process of initiating talks with potential industry partners. ]]> https://biospectrumindia.com/news/97/20185/redcliffe-labs-launches-regional-reference-lab-in-bengaluru.html https://biospectrumindia.com/news/97/20185/redcliffe-labs-launches-regional-reference-lab-in-bengaluru.html Mon, 13 Dec 2021 16:35:00 +0530 Redcliffe Labs, a unit of Redcliffe Lifetech in the US and India, recently launched a large regional reference lab in Bengaluru. The new lab is well equipped to process more than 500 tests in-house with 1000 health packages every day and other test results are processed from the central facility of the company in Noida. The lab provides all diagnostic test reports within 8 to 12 hours post receiving the sample.    The company is currently present in 40+ cities, and with the demand surge for online bookings, the company is planning to expand to around 120+ cities in the next 18 months.   ]]> https://biospectrumindia.com/news/97/20180/philips-completes-1000-active-interventional-suite-installations-in-india.html https://biospectrumindia.com/news/97/20180/philips-completes-1000-active-interventional-suite-installations-in-india.html Mon, 13 Dec 2021 15:05:00 +0530 Royal Philips has announced the completion of 1000 active Cath lab (interventional suite) installations in India. Over the last quarter, the company has installed its state-of-the-art Azurion cath labs at major sites across the country including Fortis, Apollo, Aster, Manipal, NH and Jayadeva Institute of Cardiovascular Sciences and Research Hospitals.   The completion of 1000 active cath lab installations mark a major milestone in Philips’ mission to create innovative solutions designed to meet the company’s Quadruple Aim of better health outcomes, improved patient experience, improved staff experience, and lower cost of care.   Over the next few years, Philips aims to double the number of its active cath labs in India with a special focus on improving the accessibility to quality cardiac and neurovascular care in tier II and tier III cities.    Philips is continuously innovating to bring in solutions such as the first spectral detector angio-CT solution that combines breakthrough spectral detector CT imaging and real-time fluoroscopy in a flexible environment where all modalities are operated through Philips Image-Guided Therapy System – Azurion with FlexArm. Philips’ Spectral detector CT imaging in the interventional suite will bring valuable additional information in minimally invasive procedures for areas such as oncology, stroke, and trauma care.   ]]> https://biospectrumindia.com/news/97/20166/tv-sd-to-launch-medical-device-testing-lab-in-bengaluru.html https://biospectrumindia.com/news/97/20166/tv-sd-to-launch-medical-device-testing-lab-in-bengaluru.html Fri, 10 Dec 2021 14:55:00 +0530 TÜV SÜD has laid the foundation stone for a new state-of-the-art facility for testing and certifying electrical and electronic products and medical devices (active and non-active) to national and international standards in Bengaluru. The new integrated office and lab facility is scheduled for completion in early 2023.   The ground-breaking ceremony was held in the presence of Niranjan Nadkarni, CEO, TÜV SÜD South Asia, South East Asia, Middle East & Africa Region, and Ezhilan Neelan, Senior VP, Product Service, TÜV SÜD South Asia and other South Asia Management Members.   With an investment of €15 million, spanning across three acres and comprising 70,000 sq feet in Phase 1, the new integrated office and laboratory are located in KIADB Hitech Defense and Aerospace Park, Devanahalli, Bengaluru and will be the second lab facility in Bengaluru.   As a result of this investment, TÜV SÜD will be able to offer a one-stop testing and certification solution for most electrical and electronic products & medical devices.     ]]> https://biospectrumindia.com/views/97/20154/future-trends-for-diagnostic-industry-in-2022.html https://biospectrumindia.com/views/97/20154/future-trends-for-diagnostic-industry-in-2022.html Wed, 08 Dec 2021 16:50:00 +0530 Diagnostics are the mainstay of the detection, diagnosis and assessment of any disease. Over 70 per cent of the medical decisions regarding disease treatment, management and prevention are based on diagnostics. They are a crucial tool in preventive healthcare as well.    While all through 2020-21, the diagnostics industry was primarily driven by the COVID-19 pandemic, it has been rapidly trying to keep pace with the Sars-Cov-2 virus and its emerging new mutants in a veritable combat mode to meet the huge challenge in catering to the deluge of urgent doorstep sample collection, quick turnaround time and speedy delivery of reports, it has been pushed into devising innovative techniques and newer tests to deal with the same with upgraded equipment and implementing the latest software applications to scale-up to the demand of the burgeoning volume of tests required to be conducted, while keeping a sharp eye on quality control and accuracy and affordability.    All the while, it is to be borne in mind that it had to cope with tremendous pressures of limitations like social distancing in the lockdown scenario, and yet spruce up its act in bridging the gap in the demand-supply chain, despite a lack of skilled technicians, and managing and collating a humungous volume of data, and keep up with the extensively hectic research and development in the field.  The pandemic scenario has accelerated an entire paradigm shift in the diagnostics industry, heralding an era of phenomenal revolution concerning its scope and capacity, and auguring glad tidings for unprecedented economic growth.    Healthcare has become one of India's largest sectors, both in terms of revenue and employment. The COVID-19 pandemic has impacted the level of health awareness, and the need for quality preventive healthcare and health insurance in the most positive manner, shaping new consumer-friendly models of care delivery for all. Consumerisation, automation and consolidation are three trends to look out for.    The way forward for diagnostics is point-of-care testing,  self-testing kits, genome testing and the implementation of artificial intelligence (AI)-based analytic solutions to cope with the anticipated increase in the total volume of tests in future in the wake of a possible third wave and its aftermath. The global point of care diagnostics market is segmented based on product, end-user, mode of prescription, and geography. Globally, the size of the point of care diagnostics market was valued at $22,975 million in 2015 and is expected to reach $43,336 million by 2022, growing at a CAGR of 9.4 per cent from 2016 to 2022.    In India, the diagnostic industry stands at a whopping Rs 675 billion and is estimated to grow at a rapid annual rate of <10 per cent over the next five years, egged on by increasing wellness and healthcare awareness (due to which home testing has come into being in a much bigger way), rapid rise in lifestyle diseases like diabetes and cardiovascular diseases due to sedentary lifestyle, preventive healthcare testing, insurance services, and the overall rise in the spending power of people among all strata of society. Of this Rs 675 billion market, stand alone centres constitute 47 per cent of the market, hospital labs constitute 37 per cent and diagnostic chains constitute 16 per cent of the market share, respectively. From a $9 billion market in 2018, it jumped from a 6 per cent growth overall to 20-25 per cent. Digital and technological innovations are now integral to this industry, supported by its national health policies and programs that aim to make affordable healthcare accessible for all sections of society, including the rural population. This resulted in a proper assessment of the country’s disease burden, disease trends and effective collation of data, and extensive emphasis on research. The government has spruced up its efforts to provide incentives for growth in the domestic medical devices industry and also encouraging FDI (Foreign Direct Investment), to achieve a leading rank in the medical devices manufacturing industry. Furthermore, marketing communication techniques are showing a huge improvement as well – e.g. health tracking applications, telemedicine, online consultation, highly sophisticated data collation software applications, increased awareness of diagnostic tests and health insurance services – to name a few.    The healthcare market can increase three-fold to Rs 8.6 trillion ($133.44 billion) by 2022. In Budget 2021, India’s public expenditure on healthcare stood at 1.2 per cent as a percentage of the GDP. The Govt. of India aims to increase healthcare spending up to 3 per cent of its GDP by 2022. The healthcare market can increase three-fold to Rs. 8.6 trillion ($ 133.44 billion) by 2022. This is also expected to boost employment in the healthcare sector and generate 2.7 million jobs between 2017 and 2022.    2022 will see a boost in the demand for preventive and curative healthcare. Innovative technology like robotic process automation has emerged as a logical solution at high-end diagnostic centres, along with digitisation to cover the lacunae in the area of skilled lab technicians and personnel, as well as improved precision and quicker results. To support these innovations, advanced equipment and machinery have further exhibited a hugely positive impact on the diagnostic services market. Online marketing, telemedicine, and employing social media as a tool for building brand awareness will make tremendous strides. The easy availability of doorstep collection, walk-in services and quick results is a huge boost for the diagnostics industry.    --- Dr Angeli Misra, Director Lifeline laboratory   ]]> https://biospectrumindia.com/news/97/20113/icmr-approved-ag-instalume-by-agappe-can-detect-omicron-variant.html https://biospectrumindia.com/news/97/20113/icmr-approved-ag-instalume-by-agappe-can-detect-omicron-variant.html Fri, 03 Dec 2021 09:50:00 +0530 Ernakulam-based Agappe Diagnostics' AG InstaLume, the rapid molecular diagnostic confirmatory test solution for COVID-19 strains, can detect all the 13 major variants of the globe such as, ο (Omicron) strains of South Africa, μ (Mu) strains of Colombia, λ (Lambda) strain of Peru, κ (Kappa) strain of India, ι (Iota) strain of America, Θ (Theta) Strain of Philippines, η (Eta) strain from multiple countries, ζ (Zeta) Strain of Brazil, ε (Epsilon) Strain of USA, δ (Delta) strain of India, γ (Gamma) strain of Brazil, β (Beta) Strain of South Africa, α (Alpha) strain of UK (source WHO -Label detection About reactivity Mutant strain confirmed by Infectious Disease Research Institute). As per the reports received, all corona variants of concern and variants of interest are well detected by the AG InstaLume and it was found that the reactivity is equivalent to conventional strains.RT-LAMP can detect the Nucleocapsid(N) gene and RNA dependent DNA polymerase (RDRP) gene. The platform has been introduced in India by Agappe Diagnostics since 2020. AG InstaLume, approved by ICMR and the government can detect Omicron strain, the latest variant in limelight.  ]]> https://biospectrumindia.com/news/97/20111/lifecell-diagnostics-introduces-novaseq-6000.html https://biospectrumindia.com/news/97/20111/lifecell-diagnostics-introduces-novaseq-6000.html Thu, 02 Dec 2021 16:35:00 +0530 LifeCell has announced the addition of the ‘NovaSeq 6000’ sequencing system to its diagnostic technology platform. LifeCell will be able to leverage its technical expertise to improve scalability, support a varied range of applications, and simplify the workflow. It will provide high throughput speed and flexibility to carry out studies or testing which require processing a large amount of data- but in a faster and more economical way.  NovaSeq 6000 will help LifeCell to revolutionise the healthcare sector by enabling the generation of high-throughput, high-quality sequencing data in a short turnaround time; providing rapid diagnosis of sick newborns admitted in intensive care units. It will offer rapid and reliable diagnostic services to expectant mothers who have a history of genetic abnormalities. Further, it will upskill to sequence viral and bacterial genomes for efficient patient management and conduct large-scale genomics projects with large volumes at an unprecedented depth and coverage of the genome. ]]> https://biospectrumindia.com/news/97/20107/neuberg-diagnostics-opens-10-labs-in-delhi-chandigarh-haryana-and-up.html https://biospectrumindia.com/news/97/20107/neuberg-diagnostics-opens-10-labs-in-delhi-chandigarh-haryana-and-up.html Thu, 02 Dec 2021 15:15:00 +0530 Chennai-based Neuberg Diagnostics has announced the launch of 10 diagnostics labs and 100+ touchpoints across Delhi, Chandigarh, Haryana, and Uttar Pradesh.   The 10 diagnostic labs are wholly owned by Neuberg while the 100+ touch points are set up in their own or franchisee business model. The 10 wholly-owned labs are equipped to conduct and process a wide variety of tests.    Collectively, these 10 laboratories are capable to process about 10,000 samples in a day and deliver results within the given turnaround time which differs from test to test while maintaining the best-in-class quality.     Out of 10, two reference labs are in Sector-62 in Noida and Lucknow, whereas the other eight labs are in Sector-51 and Sector-48 in Noida, Patparganj and Punjabi Bagh in New Delhi, Sector-14 and Sector-47 in Gurugram, and Chandigarh and Panchkula. ]]> https://biospectrumindia.com/news/97/20066/ge-healthcare-advances-lung-cancer-diagnosis-with-ai.html https://biospectrumindia.com/news/97/20066/ge-healthcare-advances-lung-cancer-diagnosis-with-ai.html Fri, 26 Nov 2021 00:00:00 +0530 GE Healthcare and Optellum have signed a letter of intent to collaborate to advance precision diagnosis and treatment of lung cancer. Optellum’s Virtual Nodule Clinic identifies and scores the probability of malignancy in a lung nodule, which is key to determining whether biopsy is necessary, and accelerating diagnosis. It is the only FDA-cleared artificial intelligence (AI)-assisted diagnosis software for early-stage lung cancer, and has been shown to improve the sensitivity and specificity of malignancy assessments of indeterminate nodules, enabling pulmonologists and radiologists to make optimal clinical decisions. GE plans to collaborate with Optellum’s sales team on the distribution of the Virtual Nodule Clinic and work with Optellum to integrate the platform with AI solutions powered by GE Healthcare’s Edison platform. In addition, the companies intend to bring results from Optellum’s Lung Cancer Prediction AI into the existing workflow of various GE Healthcare technological pathways, including CT and PACS. ]]> https://biospectrumindia.com/news/97/20056/ampath-launches-pathology-lab-in-mumbai.html https://biospectrumindia.com/news/97/20056/ampath-launches-pathology-lab-in-mumbai.html Thu, 25 Nov 2021 16:30:00 +0530 American Institute of Pathology & Laboratory Sciences (AMPATH) has launched its pathology laboratory in Mumbai. It will offer over 2450 tests and has collaborated with UPMC, one of the top-ranked hospitals in the US.   AMPATH offers a wide range of best-in-class diagnostic services with over 2450 tests from Clinical Biochemistry, Hematology, Clinical Pathology, Microbiology, Immuno Phenotyping, Serology, Immunology, Histopathology, Cytology, Immunohistochemistry, Molecular diagnosis, NGS, Cytogenesis and much more.    Currently, AMPATH has 10 existing Labs, 1700+ clients and two upcoming Labs in India. It delivers a spectrum of advanced diagnostic services emphasising quality, ethics, innovation, and best-in-class laboratory practices with reliable performance.   ]]> https://biospectrumindia.com/news/97/20047/dr-lal-pathlabs-with-ibex-medical-analytics-to-deliver-ai-powered-cancer-diagnostics.html https://biospectrumindia.com/news/97/20047/dr-lal-pathlabs-with-ibex-medical-analytics-to-deliver-ai-powered-cancer-diagnostics.html Wed, 24 Nov 2021 15:30:00 +0530 Dr Lal PathLabs and Ibex Medical Analytics, the market leader in artificial intelligence (AI)-powered cancer diagnostics, announced the first deployment in India of an AI platform that supports pathologists during routine cancer diagnosis and helps improve the quality and turnaround time of cancer tests.    Ibex’s AI technology and Philips’ IntelliSite pathology solution demonstrated impressive performance across multiple clinical studies and in live clinical deployments in Europe and the US. This partnership marks a continued journey to find the most innovative products that help patients and doctors.    Ibex transforms cancer diagnosis by harnessing artificial intelligence and machine learning technologies at an unprecedented scale. Ibex's Galen platform helps pathologists improve the quality of cancer diagnosis, implement real-time quality control, reduce diagnosis time and boost productivity. The platform was recently granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) and is CE marked in Europe for breast and prostate cancer detection in multiple workflows.  ]]> https://biospectrumindia.com/news/97/20045/agappe-diagnostics-offers-covid-19-confirmatory-test-in-35-mins.html https://biospectrumindia.com/news/97/20045/agappe-diagnostics-offers-covid-19-confirmatory-test-in-35-mins.html Wed, 24 Nov 2021 15:05:00 +0530 Ernakulam-based Agappe Diagnostics is launching India’s fastest COVID-19 confirmatory test solution without RNA extraction step, on RT-LAMP platform, with test results in 30-35 minutes from sample collection time. It will have test reports with more than 98.7 per cent sensitivity and 100 per cent specificity and is known as ‘AG InstaLume’ Reagent Kit. In the process, nasopharyngeal swab can be collected and mixed directly in the lyse buffer and then it is directly tested with AG InstaLume kit.  The reaction vial can be loaded in MISPA LUME, Real-time LAMP Analyzer. Thus, the sample to report turnaround time is reduced to 35 minutes with high accuracy. This is the best option for airports, religious places, conventions, social gatherings, hospitals for patients, by-standers & all public functions where one compact machine can give 16 test results in 35 minutes. Agappe has joined hands with SPICE HEALTH, a Division of Spicejet Airways, in setting up a Rapid Molecular Diagnostic solution for passengers going to UAE countries at Varanasi & Amritsar international airports. Coimbatore international airport also employs the service of a Rapid Molecular Diagnostic solutions from Agappe. ]]> https://biospectrumindia.com/news/97/20033/medgenome-labs-acquires-trident-diagnostics.html https://biospectrumindia.com/news/97/20033/medgenome-labs-acquires-trident-diagnostics.html Tue, 23 Nov 2021 13:10:00 +0530 Bengaluru-based MedGenome Labs has acquired Trident Diagnostics & Healthcare, a diagnostics and radiology healthcare centre, also based in Bengaluru. The partnership will help MedGenome further democratise genetic testing by providing an integrated tests menu to clinicians, patients, and consumers across Karnataka.    Earlier this year, MedGenome Labs also ventured into the direct-to-consumer (DTC) category under the brand name Genessense, offering specialised, evidence-based genetic screening tests that provide insights into a person’s health much before the onset of symptoms. The acquisition will help expand the access to these tests to consumers in Tier II and III markets.    The Trident team was advised by Smark Capital a Bengaluru-based transaction advisory firm. Smark Capital were the exclusive advisors to Trident management on this deal.     ]]> https://biospectrumindia.com/news/97/20016/first-of-its-kind-mri-facility-opens-at-national-brain-research-centre-manesar.html https://biospectrumindia.com/news/97/20016/first-of-its-kind-mri-facility-opens-at-national-brain-research-centre-manesar.html Fri, 19 Nov 2021 00:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh has launched first of its kind, latest, world's most sophisticated MRI facility at the National Brain Research Centre (NBRC), Manesar Haryana. The Minister said, with this facility, India embarks on new frontiers of human Neuroscience with a unique and powerful 3T MRI platform of outstanding performance. He informed that MRI Scanner Prisma from Siemens, Germany, is being used by several international initiatives, like Brain initiative of USA, the European human brain project. This new facility can run intense scanning modalities very fast, which reduces the scanning time for patients by almost a quarter from earlier generation machines. This is being used to develop human cohort data for patients suffering from common brain and mental health disorders including Parkinson's Disease,Alziemer's Disease, anxiety, depression, PTSD, bipolar, anxiety, depression etc. The novelty of this machine is that it can detect and quantify highly sensitive receptors and antioxidants from the brain which has a direct link with onset of various brain disorders like Alzheimer’s, Parkinson’s and psychiatric disorders.  ]]> https://biospectrumindia.com/news/97/20017/indigenously-developed-early-stage-breast-cancer-detection-blood-test-gets-usfda-breakthrough-designation.html https://biospectrumindia.com/news/97/20017/indigenously-developed-early-stage-breast-cancer-detection-blood-test-gets-usfda-breakthrough-designation.html Fri, 19 Nov 2021 00:00:00 +0530 Datar Cancer Genetics, serving cancer patients in India, UK, European Union, United States, GCC, has announced that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Designation’ for its blood test to detect early-stage Breast Cancer.  The blood test uses a proprietary technology developed by the company to detect Circulating Tumor Cells and Clusters specific to Breast Cancer with very high accuracy. Data from clinical trials has shown that the test can detect Stage 0 (DCIS) and Stage 1 Breast Cancers with accuracy of better than 99% without any false positives. The test has been validated on more than 20,000 women comprising healthy and cancer patients. The test requires only 5 ml blood and does not involve exposure to any radiation or discomfort associated with mammography.   “This is for the first time that women above the age of 40 can obtain a Breast Cancer specific blood test in consultation with their physician from the convenience and privacy of their home or office”, said Rajan Datar, Chairman of the Company.  The test is already available in Europe and is CE marked. The test will be available in India shortly as ‘EasyCheck’ and will be reasonably priced. The company is in discussions with several leading healthcare providers for ready accessibility. The company has also validated a blood test to detect multiple cancers including several extremely lethal malignancies such as Lung, Pancreas and Ovaries and will be available next year.     ]]> https://biospectrumindia.com/news/97/20003/vice-president-calls-for-making-healthcare-affordable-and-accessible-to-all.html https://biospectrumindia.com/news/97/20003/vice-president-calls-for-making-healthcare-affordable-and-accessible-to-all.html Thu, 18 Nov 2021 14:40:00 +0530 The Vice President (VP), M Venkaiah Naidu emphasised the need to ensure affordable and accessible healthcare for all and suggested the modern multi-speciality hospitals also start satellite centres in rural areas. Inaugurating Yoda Life Line Diagnostics in Hyderabad, the VP praised the Central government’s decision to set up at least one medical college in each district. In this regard, he further suggested the governments envision one medical college in each revenue sub-division. "This would not only address the shortage of trained manpower in the medical profession but also increase people’s access to quality healthcare," he said.  Expressing his happiness over the setting up of this state-of-the-art diagnostic centre in Hyderabad, Naidu called for leveraging advances in technology to also provide such facilities for the people in rural areas.  Appreciating the efforts of Sudhakar Kancharla in bringing a fully equipped state-of-the-art diagnostic laboratory capable of in-depth disease characterisation, the VP lauded YODA for using the latest prediction technologies for the benefit of people.    ]]> https://biospectrumindia.com/news/97/19954/jubilant-opens-new-chemistry-innovation-research-centre-in-greater-noida.html https://biospectrumindia.com/news/97/19954/jubilant-opens-new-chemistry-innovation-research-centre-in-greater-noida.html Fri, 12 Nov 2021 09:20:00 +0530 Bengaluru-based contract research organisation (CRO) Jubilant Biosys has announced the expansion of its facilities to support its discovery chemistry and in-vitro ADME (absorption, distribution, metabolism, and excretion) Service offerings.   Jubilant Biosys provides services for Turning Point Therapeutics for multiple small molecule oncology research programmes. Turning Point is a precision oncology company developing next-generation therapies that target genetic drivers of cancer.   Services for Turning Point Therapeutics will be conducted out of the newly built state-of-the-art Chemistry Innovation Research Center (CIRC) in Greater Noida.   The CIRC has an initial capacity of 500 full-time equivalents (FTEs) enabling higher operational performance for discovery chemistry services and also rapid turn-around of in-vitro ADME data for client projects. ]]> https://biospectrumindia.com/news/97/19941/lifecell-diagnostics-unveils-lsdcheck-testing-for-newborns.html https://biospectrumindia.com/news/97/19941/lifecell-diagnostics-unveils-lsdcheck-testing-for-newborns.html Wed, 10 Nov 2021 17:30:00 +0530 LifeCell Diagnostics, based in Chennai, has announced the inclusion of a new and advanced Lysosomal Screening Disorder (LSD) screening ‘LSDCheck’ to their newborn screening test menu.    Lysosomal storage disorders are a group of approximately 50 rare inherited metabolic conditions that manifest in some ways and vary in severity from moderate to severe. It is crucial to diagnose and manage these conditions as soon as possible before irreversible damage is caused.    LifeCell's LSDCheck is a test that uses standardised CE-IVD approved kits that utilize the powerful analytical technique, LCMSMS (Liquid Chromatography with Tandem Mass Spectrometry) based enzyme detection to screen six LSD conditions. Hence, LSDCheck comes with the ultimate promise of early diagnosis, as well as access to prompt management and treatment. LSDCheck’ is India’s first CE-IVD approved LCMSMS-based Testing Kit for LSD in Newborns.        ]]> https://biospectrumindia.com/news/97/19933/medtronic-launches-cryoballoon-catheter-for-treatment-of-atrial-fibrillation-in-india.html https://biospectrumindia.com/news/97/19933/medtronic-launches-cryoballoon-catheter-for-treatment-of-atrial-fibrillation-in-india.html Tue, 09 Nov 2021 00:00:00 +0530 India Medtronic has announced the launch of Arctic Front™ Cardiac Cryoablation Catheter System, the first and only cryoballoon catheter approved by the Central Drugs Standard Control Organisation (CDSCO) for treatment of atrial fibrillation (AF) in India. Dr. Balbir Singh, chairman of Cardiology, Pan Max Hospital Saket, Delhi, successfully performed the first procedure in India using the Arctic Front Cardiac Cryoablation Catheter System. Cryoballoon catheter ablation, a minimally invasive procedure, is one of the therapeutic modalities to manage AF. “AF is a progressive disease, meaning over time patients can experience more frequent, and longer episodes. Cryoballoon ablation is a safe and effective treatment before or after medication therapy to control atrial fibrillation,” said Dr. Singh. “By treating patients with the most advanced, clinically relevant technology, we are better equipped to successfully manage their atrial fibrillation, thereby improving their overall quality-of-life.” The Medtronic cryoballoon catheter was developed specifically to achieve pulmonary vein isolation. This innovative technique has been used to treat more than 1,000,000 patients in more than 80 countries with robust safety and effectiveness evidence in more than 1200 peer-reviewed articles. ]]> https://biospectrumindia.com/news/97/19923/suburban-diagnostics-launches-centre-of-excellence-in-haematology.html https://biospectrumindia.com/news/97/19923/suburban-diagnostics-launches-centre-of-excellence-in-haematology.html Mon, 08 Nov 2021 17:50:00 +0530 Suburban Diagnostics has launched its Centre of Excellence (COE) in haematology through a webinar on hemoglobinopathies. The COE is a shared facility that provides leadership, best practices, research support and training in the diagnosis of several common and uncommon haematological disorders.    The Centre of Excellence in haematology offers a wide range of more than 200 tests in general haematology, immunohematology, anaemia, coagulation disorders, acute leukaemia, immunodeficiency, myelodysplastic syndromes, myeloproliferative neoplasms, chronic lymphoproliferative disorders and multiple myeloma, to name a few.    COE abides by international standards and guidelines set by the CLSI for Hematology, Coagulation, and Flow Cytometry; the International Society for Laboratory Hematology (ISLH); the International Society for Thrombosis & Hemostasis (ISTH) and the WHO for Immunophenotyping of Leukemia/Lymphoma.  ]]> https://biospectrumindia.com/news/97/19918/genes2me-unveils-40-mins-extraction-free-rt-pcr-testing-kit.html https://biospectrumindia.com/news/97/19918/genes2me-unveils-40-mins-extraction-free-rt-pcr-testing-kit.html Mon, 08 Nov 2021 12:10:00 +0530 Gurugram-based startup Genes2Me has recently launched its brand new product RT- Direct Multiplex RT-PCR kit for COVID-19.   The kit is based on the gold standard RT-PCR method with coverage of three target genes specific to SARS-COV-2 along with IC, which is much advanced than all others having 1 or 2 target genes.   This greatly increases the sensitivity of the RTPCR test to detect samples with different mutations/variants as this kit targets three different Sars-cov-2 target regions.   Validated at the Indian Council of Medical Research (ICMR) approved Centre with 100 per cent sensitivity and specificity, the newly launched kit can deliver results in just 40 minutes.   RT-Direct test protocol does not require any manual extraction step or automated instrument, making it faster and easier to deliver results. It will also increase the throughput of any testing lab by threefold compared to the normal RT-PCR test protocol time of 120-150 minutes. The company has also received DCGI approval for this kit.   The kit is now easily available in India from the second week of November 2021 and for the international market, it will be available after a global launch at Medica, event on November 15 at Messe Dusseldorf, Germany.   ]]> https://biospectrumindia.com/news/97/19890/holborn-wells-speedbio-india-jv-to-invest-1-m-for-ivd-manufacturing.html https://biospectrumindia.com/news/97/19890/holborn-wells-speedbio-india-jv-to-invest-1-m-for-ivd-manufacturing.html Mon, 01 Nov 2021 16:05:00 +0530 Holborn Wells, a UK-based healthcare company that recently established an IVD business unit in India has concluded a joint venture with SpeedBio to establish an IVD manufacturing unit in India.   SpeedBio is one of the leading IVD promoters in the region with a team of former executives from leading diagnostics and healthcare companies such as Siemens and CORE Diagnostics.   As per a joint statement by Sudhanshu Srivastava, CEO, Holborn Wells India and Santosh Pandey, CEO, SpeedBio India, "The new venture is in line with Government’s ‘Made in India’ initiative which will see the nation emerge as a major player in the provision of quality IVD products in a global supply chain. We believe that through the convergence of this supply chain and availability of resources we have at our disposal, we can rapidly expand to emerging markets and provide high-quality IVD products at reduced price points as a result of considered innovation."    Both parties are expected to invest a total of $1 million over the coming months to establish the Holborn SpeedBio brand as a leading IVD provider for the market.   The newly formed joint venture intends to launch and manufacture a portfolio of over 150 IVD products to market within the next year. ]]> https://biospectrumindia.com/news/97/19885/iit-d-aiims-establish-coe-for-disability-assistive-technology.html https://biospectrumindia.com/news/97/19885/iit-d-aiims-establish-coe-for-disability-assistive-technology.html Sat, 30 Oct 2021 00:00:00 +0530 The Indian Institute of Technology, Delhi (IIT-D) and AIIMS New Delhi, have jointly set up ‘Centre for Advanced Research and Excellence in Disability & Assistive Technology (CARE-DAT)’, a Centre of Excellence (CoE) created under the aegis of the Indian Council of Medical Research (ICMR). The Center was recently inaugurated by Prof V. Ramgopal Rao, Director, IIT Delhi and Dr Randeep Guleria, Director, AIIMS, New Delhi in the presence of senior functionaries from both sides. The mandate of the Centre is to encourage comprehensive research on an identified problem with the aim of generating new knowledge and improving the holistic understanding of neurological diseases such as stroke and provide assistive technology solutions for rehabilitation of patients. It is established with the vision - to design novel technological solutions, therapeutic protocols & clinical validation for the solutions in Neuro-assistive technology and thereby providing commercial-ready technology under the “Make in India” initiative of the Government of India. ]]> https://biospectrumindia.com/news/97/19882/yashoda-hospitals-secunderabad-launches-biplane-neuro-cath-lab.html https://biospectrumindia.com/news/97/19882/yashoda-hospitals-secunderabad-launches-biplane-neuro-cath-lab.html Fri, 29 Oct 2021 17:25:00 +0530 Yashoda Hospitals Secunderabad has launched a world-class state-of-the-art technology called 'Bi-Plane Neuro Angio Procedure Suite' with DTAS (Direct to Angio Suite) technology on the occasion of World Stroke Day. The Governor of Telangana, Dr Tamilsai Soundarajan, inaugurated the Biplane Neuro Cath Lab.   Dr Suresh Giragani, Senior Neuro & Interventional Radiologist, Yashoda Hospitals Hyderabad said, “Yashoda Hospitals is at the forefront of brain stroke treatment by launching ‘Stroke Care on Wheels’ special ambulances to provide treatment to brain stroke patients as quickly as possible. These special ambulances are aimed at reducing the time taken from home to the hospital. Yashoda Hospitals is the first in the state to offer the latest technology called 'Bi-Plane Neuro Angio Procedure Suite' which works with DTAS (Direct to Angio Suite) technology at Yashoda Hospitals which already have highly advanced medical procedures for brain stroke treatment. With this 'Bi-Plane Neuroangio Procedure Suite,' the scanning tests for brain stroke patients, their results, subsequent treatment decisions, and treatments (Thrombolysis and Thrombectomy) are all done in one room, on the same machine, so that the patient does not have to spend precious time during the golden hour. Thrombolysis and Thrombectomy treatment will be done swiftly. " Dr Anand Balasubramaniam, Senior Neurosurgeon, Dr Komal Kumar, Senior Neurologist & others participated in the programme along with many Neurologists and Neurosurgeons. ]]> https://biospectrumindia.com/news/97/19874/pathkind-diagnostics-opens-pathology-lab-in-nagpur.html https://biospectrumindia.com/news/97/19874/pathkind-diagnostics-opens-pathology-lab-in-nagpur.html Fri, 29 Oct 2021 13:25:00 +0530 Pathkind Diagnostics has made a foray in Maharashtra with a state-of-the-art pathology lab in Congress Nagar and Nagpur. The move is in line with the company’s aggressive expansion plans in Maharashtra and other western and central states of India. The new lab was inaugurated by Nitin Gadkari, Minister of Road Transport and Highways of India (Govt. of India) and Sanjeev Vashishta, MD & CEO, Pathkind Diagnostics. Pathkind Diagnostics has opened large-format labs in Nagpur, Raipur, Jabalpur and very soon more labs will be launched in Mumbai, Pune, Aurangabad, Goa, Bhopal and Indore to be able to provide superior quality diagnostics services to the people residing in western and central parts of India at their doorsteps. Pathkind has opened almost 200 collection centres in that geography. ]]> https://biospectrumindia.com/news/97/19853/advamed-launches-code-of-ethics-for-medtech-sector.html https://biospectrumindia.com/news/97/19853/advamed-launches-code-of-ethics-for-medtech-sector.html Wed, 27 Oct 2021 15:05:00 +0530 The Advanced Medical Technology Association (AdvaMed) has launched the AdvaMed Code of Ethics on interactions with healthcare professionals in India. It provides medical technology and diagnostics makers with compliance principles and guidance that addresses key legal risk areas that govern business relationships and activities. The code is intended to help companies make reasonable and appropriate decisions that align with the code’s cornerstone values of innovation, education, integrity, respect, responsibility and transparency. The AdvaMed code aims to bridge the gap and drive cognizance of the unique requirements of the medtech sector concerning training and clinical research. The code has considered provisions of the UCPMP, MCI guidelines, local anti-corruption laws in India, the UK, and the US, along with the specific requirements of medical device companies. "We urge all med-tech companies – including small, medium, and large size firms and all the representatives on the forefront of these businesses to proactively adopt the code. The code will not only standardise interactions with healthcare professions during their business but also help maintain a healthy MedTech innovation ecosystem for the benefit of the industry as a whole,” Abby Pratt, Senior VP, Global Strategy & Analysis, AdvaMed, said. The AdvaMed India Code was developed in response to a recommendation from the AdvaMed India Executive Committee to promote greater consistency across the MedTech industry in India. ]]> https://biospectrumindia.com/news/97/19847/transasia-launches-indias-first-high-sensitivity-hepatitis-c-testing-kit.html https://biospectrumindia.com/news/97/19847/transasia-launches-indias-first-high-sensitivity-hepatitis-c-testing-kit.html Tue, 26 Oct 2021 17:55:00 +0530 Transasia Bio-Medicals, based in Mumbai, has announced the launch of a high sensitivity testing kit for the hepatitis C virus. Based on the latest method, the ErbaLisa HCV Gen 4 Ag+Ab kit, is India’s first and only indigenously developed 4th gen ELISA kit and has been evaluated by the National Institute of Biologicals (NIB).   ErbaLisa HCV Gen4 Ag+Ab kit is intended for the detection of HCV core antigen (viral protein) and anti-HCV antibodies, simultaneously, in human serum and plasma. It has a sensitivity of 100 per cent and a specificity of 99.67 per cent.   The simultaneous detection of antigen and antibodies with ErbaLisa HCV Gen4 Ag+Ab will greatly aid in screening HCV more accurately, as the window period for HCV detection will be reduced to less than 28 days.   The ErbaLisa HCV Gen4 Ag+Ab kit is fully adaptable to reputed automated ELISA processors. The assay can be run in 150 mins only and is pre-programmed on Transasia’s Elan 30s, a fully automated ELISA system and Lisa XL, a fully automated, six plate microprocessor. ]]> https://biospectrumindia.com/news/97/19843/healthium-medtech-introduces-surgical-wound-dressing-trushield-nxt.html https://biospectrumindia.com/news/97/19843/healthium-medtech-introduces-surgical-wound-dressing-trushield-nxt.html Tue, 26 Oct 2021 16:05:00 +0530 Bengaluru-based Healthium Medtech has launched TRUSHIELD NXT surgical wound dressing, adding to its portfolio of patented products in the wound care and infection prevention segments.   In addition to wound care, Healthium’s current product portfolio focuses on advanced surgery, urology and arthroscopy products covering 52,000 stock-keeping units. The announcement comes after Healthium’s acquired CareNow Medical last month.    TRUSHIELD NXT combines the advantages of a 3D hydrocellular substrate and patented infection prevention technology to offer a complete wound care system that provides 360-degree wound protection.   It provides exudate and moisture management while remaining waterproof. Its patented technology continuously inhibits pathogen growth with a unique non-leaching, non-depleting kill mechanism. It has patents in the US, Europe and India.       ]]> https://biospectrumindia.com/news/97/19839/iitpl-aims-to-establish-cathlabs-in-every-718-district-in-india-by-2030.html https://biospectrumindia.com/news/97/19839/iitpl-aims-to-establish-cathlabs-in-every-718-district-in-india-by-2030.html Tue, 26 Oct 2021 15:30:00 +0530 Bengaluru-based, Innovation Imaging Technologies Pvt Ltd (IITPL), recently inaugurated a state-of-the-art manufacturing facility for cathlabs. IITPL aims to establish cathlabs in every 718 district in India by 2030.   IITPL boasts of having the smallest footprint for a cathlabs, which consumes lesser space as well as saves long-term recurring costs of running the facility. It has optimised harmful X-ray radiation, with 30 per cent less input dose, thereby resulting in much lesser scatter radiation, hence safer. Furthermore, CATH LAB has a world-class industrial design and has won Design Awards internationally as well.   Present on the occasion were Nitin Gadkari, Minister for Road Transport and Highways, Government of India, Dr K Sudhakar, Minister of Medical Education and Health, Government of Karnataka, Dr C N Ashwath Narayan, Minister of Science and Technology, Higher Education and IT, BT, Government of Karnataka, Dr Jitendra Sharma, MD and CEO, AMTZ, Dr CN Manjunath, Director, Sri Jayadeva Institute of Cardiovascular Sciences and Research and Gaurav Agarwal, MD, IITPL, and other senior members of the organisation were also present.  ]]> https://biospectrumindia.com/news/97/19803/lumiradx-bags-cdsco-approval-for-covid-19-antigen-test.html https://biospectrumindia.com/news/97/19803/lumiradx-bags-cdsco-approval-for-covid-19-antigen-test.html Thu, 21 Oct 2021 09:00:00 +0530 LumiraDx, a next-generation point of care diagnostics testing company based in the UK, has received emergency use approval by the Central Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test for use in India.   The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.    In clinical studies, LumiraDx SARS-CoV-2 Antigen test demonstrated a 97.6 per cent positive agreement and 96.6 per cent negative agreement with the PCR test for patients within the first twelve days of symptom, making it one of the fastest, and most sensitive antigen point of care tests currently commercially available.    The LumiraDx SARS-CoV-2 Antigen test is a microfluidic test that runs on the LumiraDx point of care platform which scales down and integrates techniques used in laboratory analysers to provide lab-comparable diagnostic tests on a single point of care instrument.   The platform consists of a small, portable instrument; microfluidic test strip; simple, standardised workflow; and seamless, secure digital connectivity to the cloud and hospital IT systems.    ]]> https://biospectrumindia.com/news/97/19793/trivitron-diagon-vanguard-launch-coagulation-range-in-india.html https://biospectrumindia.com/news/97/19793/trivitron-diagon-vanguard-launch-coagulation-range-in-india.html Wed, 20 Oct 2021 11:05:00 +0530 Chennai-based Trivitron Healthcare has announced the launch of a new line of coagulation analyser products manufactured by Diagon. Trivitron in partnership with Diagon-Vanguard Diagnostics India has announced the introduction of these products for the Indian diagnostics market following the signing of a collaboration agreement between the companies. The new products include the COAG Line automated, semi-automated and POC systems manufactured by Diagon Hungary for reducing bleeding risk in extensive surgeries, checking the efficacy of haemostatic therapies and anti-coagulant drugs.Rajesh Patel, CEO (IVD Business), Trivitron Healthcare said, “With this launch of the product line from Diagon, we are looking to broaden the scope and scale of efficacies in patient and clinical management. The range of products will complement Trivitron’s focus on supporting patient management by offering precision in clinical diagnostic fields, such as cardiology, infectious diseases, pathology, biochemistry, as well as inflammatory and autoimmune diseases." ]]> https://biospectrumindia.com/news/97/19769/lifecell-with-sohum-innovation-labs-to-aid-in-newborn-hearing-screening.html https://biospectrumindia.com/news/97/19769/lifecell-with-sohum-innovation-labs-to-aid-in-newborn-hearing-screening.html Thu, 14 Oct 2021 13:45:00 +0530 LifeCell International has partnered with Bengaluru-based Sohum Innovation Labs to introduce an affordable Newborn Hearing Screening programme across the country. Complementing LifeCell’s RightStart Newborn Screening, the most advanced and comprehensive newborn care program, the hearing screening will benefit neonates even from remote areas across the country. Commenting on this development, Ishaan Khanna, CEO and& Executive Director, LifeCell International, said, “With Sohum on board, we have been able to add affordable hearing screening to our suite of diagnostic services that we were aiming to offer for a long time now. We also take pride in associating with an out-and-out Indian brand like Sohum Labs, through whom we are now able to serve the needs of newborns beyond urban markets."Nitin Sisodia, Founder & CEO, Sohum Innovation Labs, said, “When it comes to hearing screening devices in India, we firmly believe that we have set the gold standard." ]]> https://biospectrumindia.com/news/97/19752/upes-dehradun-develops-oxy-all-emergency-ventilator.html https://biospectrumindia.com/news/97/19752/upes-dehradun-develops-oxy-all-emergency-ventilator.html Tue, 12 Oct 2021 00:00:00 +0530 Final year students of B Tech Mechatronics from University of Petroleum and Energy Studies (UPES), Dehradun, have developed a cost-effective rapidly manufacturable and deployable emergency ventilator named OXY-ALL emergency ventilator.   The OXY-ALL Ventilator is a non-invasive positive pressure ventilator. It is compact and can be used in an emergency when there is no other option available as per the patient requirement.   The OXY-ALL Ventilator can be used for respiratory distress, obstructive sleep apnea, low-mild asthma, pulmonary oedema, low-mild pneumonia (SARS-CoV-2) virus that causes COVID-19.    It is a simple device that pumps oxygen when the patient is unable to breathe naturally. Artificial Manual Breathing Unit (AMBU) bags are used to pump oxygen directly to the nose and mouth of the patient. The AMBU has to be pressed either manually by the medical professional or can be pressed using an automation mechanism.    The OXY-ALL Ventilator was manufactured for only Rs 4500. The students of UPES are still working on improving the design and efficiency of the ventilator.   ]]> https://biospectrumindia.com/news/97/19745/molbio-diagnostics-receives-dcgi-nod-for-scrub-typhus-test.html https://biospectrumindia.com/news/97/19745/molbio-diagnostics-receives-dcgi-nod-for-scrub-typhus-test.html Mon, 11 Oct 2021 14:50:00 +0530 Goa-based Molbio Diagnostics has received approval from the Drug Controller General of India (DCGI) for its Truenat Scrub T test for Scrub Typhus, an infectious disease that can spread to humans through the bite of an infected chigger (larval mites).    Scrub Typhus affects approximately one million people in India every year. As per the PLOS report July 2021, the highest densities of cases were from Tamil Nadu (37.6% of cases), Himachal Pradesh (11%), Karnataka (8.8%), and Uttrakhand (8.5%).    Real-Time PCR is the most accurate and sensitive method of diagnosis of infection with Scrub Typhus. With Truenat testing at point of care, the disease can be detected at an early stage efficiently and can be controlled effectively.    “Truenat is a platform that has the approval to test 30+ diseases, the latest being Scrub Typhus. The single platform, Truenat, can test for all diseases with just a different chip. This is the perfect solution for quality healthcare,” Dr Chandrasekhar Nair, Director & CTO, Molbio Diagnostics added. ]]> https://biospectrumindia.com/news/97/19736/era-of-magnesium-for-orthopaedics-and-traumatology-begins-in-india.html https://biospectrumindia.com/news/97/19736/era-of-magnesium-for-orthopaedics-and-traumatology-begins-in-india.html Fri, 08 Oct 2021 00:00:00 +0530 The Central Drugs Standard Control Organisation (CDSCO) has granted German firm Syntellix the license to bring five different product families of its revolutionary bioabsorbable magnesium-based implants to market. In one fell swoop, this increases global market access and the amount of potential patients who can be treated with the company's MAGNEZIX® implants by an additional 1.38 billion to now 3.8 billion people.  The game-changer market of India, with its exceptionally good doctors and in many cases ultra-modern hospitals, plays a decisive role in the global substitution of conventional implant technologies in favour of the MAGNEZIX® platform technology. In addition, India is ideally suited for collecting further clinical data and conducting clinical trials and will also contribute significantly to the development of new, additional Syntellix products. ]]> https://biospectrumindia.com/news/97/19712/isic-inducts-mazor-x-stealth-edition-for-spine-surgeries.html https://biospectrumindia.com/news/97/19712/isic-inducts-mazor-x-stealth-edition-for-spine-surgeries.html Wed, 06 Oct 2021 17:15:00 +0530 The Indian Spinal Injuries Centre (ISIC), a super speciality institute, has integrated O-Arm, a 3D imaging system, with MAZOR X Stealth Edition, an advanced minimally-invasive robotics procedure, for spinal, orthopaedic and neurological conditions. The combination of equipment will add another cutting-edge technological upgrade for enhanced surgical precision and improve patient’s health and makes ISIC the most advanced facility in India for spinal, orthopaedic and neurological surgeries. Doctors at the Indian Spinal Injuries Centre (ISIC), New Delhi have successfully operated on two young girls, suffering from spinal deformity, using the newly inducted integrated system. The surgery combining robotics and O-Arm not only helped in improving the accuracy of inserting screws during the surgeries, but it also lowered their risk of paralysis as well as exposure to radiation, blood loss and postoperative pain. “The integrated model of health service delivery is in line with the global best practices and already in use in multiple sites across the US, Europe including the UK, Spain, Italy, Germany, Singapore, and Australia. We have operated on two teenaged girls with different types of the spinal deformity using the integrated system and have received excellent results,” says Dr HS Chhabra, Medical Director & Chief of Spine, Indian Spinal Injuries Centre, New Delhi. ]]> https://biospectrumindia.com/news/97/19701/wipro-ge-healthcare-inaugurates-first-digital-pet-mr-in-india.html https://biospectrumindia.com/news/97/19701/wipro-ge-healthcare-inaugurates-first-digital-pet-mr-in-india.html Tue, 05 Oct 2021 10:10:00 +0530 Wipro GE Healthcare has inaugurated India’s first Digital PET MR (positron emission tomography and magnetic resonance imaging). at the State Cancer Institute GMC, Guwahati, Assam. GE’s SIGNA PET/MR 2.0 is the fourth PET MR scanner in India and the first digital one.   The PET/MR was launched by M Venkaiah Naidu, Vice President of India and in the presence of Dr Himanta Biswa Sarma, Chief Minister of Assam and Keshab Mahanta – Minister Health & Family Welfare. The ability of the device to conduct two examinations simultaneously will lead to better patient outcomes.   Dr Shravan Subramanyam, MD, Wipro GE Healthcare said, “The device is packed with features and holds merit in both clinical and research applications. While MR is the best procedure for imaging soft tissue as well as functional and morphological details, PET enables clinicians to visualise cellular activity and metabolism.”   The SIGNA PET/MR 2.0 is powered by simultaneous image acquisition from GE's latest 3.0 Tesla MR technology and PET technology. When these two powerful tools are combined, clinicians will be able to see early cellular changes that can be accurately mapped onto MR images.  ]]> https://biospectrumindia.com/news/97/19679/roche-launches-cobas-pure-to-offer-more-than-230-tests-.html https://biospectrumindia.com/news/97/19679/roche-launches-cobas-pure-to-offer-more-than-230-tests-.html Thu, 30 Sep 2021 17:35:00 +0530 Roche Diagnostics India has launched cobas pure integrated solutions analyser. The new compact analyser combines clinical chemistry, immunoassay and Ion Concentration Measurement (ISE) diagnostic testing on a single platform helping labs simplify daily operations with limited space and resources. Cobas pure analyser offers the longest onboard stability of reagents allowing labs to expand their test menu. With a footprint of just two square metres, cobas pure provides clinical labs with access to more than 230 diagnostic tests across a wide range of disease areas including infectious diseases, oncology and cardiology.Narendra Varde, MD, Roche Diagnostic India, and Neighboring Markets said, “Cobas pure offers diverse critical and complex tests for patients. This consolidation of the test menu would enable labs to speedily perform hundreds of different tests using just a single test tube of the blood samples from patients. Through cobas pure, the consolidated test menu can reach beyond metros into a large number of cities where testing menu may be presently limited.” ]]> https://biospectrumindia.com/news/97/19666/medgenome-brings-easy-to-do-genetic-screening-in-india.html https://biospectrumindia.com/news/97/19666/medgenome-brings-easy-to-do-genetic-screening-in-india.html Wed, 29 Sep 2021 16:00:00 +0530 Bengaluru-based MedGenome Labs launched its direct-to-consumer category under the brand name Genessense for consumers in India. Under Genessense, MedGenome will offer specialised, evidence-based genetic screening tests that can be ordered online through the Genessense website or via e-commerce platforms in future.   The company that operates one of the biggest genomic testing labs with highly specialised tests in South Asia will initially offer two tests - namely Kardiogen and Curegen under the umbrella of personal genomics.   Kardiogen will be India’s first Polygenic Risk Score based predictive test for Coronary Artery Disease (CAD) with a proven specificity of 90 per cent for the Indian population.   Kardiogen will help one assess the risk of developing Coronary Artery Diseases (CAD) or heart attacks based on their genetic makeup while Curegen is a genome-based drug response test that will outline an individual's reaction to different drugs or medications. The test will help consumers in avoiding adverse drug reactions and improving response to medications. ]]> https://biospectrumindia.com/news/97/19658/neuroequilibriums-diagnostic-equipment-bags-european-ce-certification.html https://biospectrumindia.com/news/97/19658/neuroequilibriums-diagnostic-equipment-bags-european-ce-certification.html Wed, 29 Sep 2021 09:00:00 +0530 Indian medtech startup, NeuroEquilibrium, has secured European CE Mark regulatory approvals for its innovative diagnostic products. NeuroEquilibrium plans to expand its Advanced Dizziness and Balance Lab Services to 1,000 hospitals globally by 2023.    "The patented and innovative technology of NeuroEquilibrium got a real shot in the arm with the grant of the sixth patent in India and second patent in the US. It is a trend reversal, Indian companies looked for imported products and solutions, but now Indian innovators are going global with unique and path-breaking MedTech Products and solutions," said Rajneesh Bhandari, Founder, NeuroEquilibrium who is an IIT alumnus and a serial entrepreneur.   Recently, NeuroEquilibrium has supplied its Vertigo and Dizziness lab to prestigious institutions like AIIMS Delhi, AIIMS Raipur, and ISRO, which will help the common man suffering from dizziness and balance disorders.  ]]> https://biospectrumindia.com/news/97/19636/fujifilm-unveils-new-cad-eye-function-for-colon-polyp-detection-.html https://biospectrumindia.com/news/97/19636/fujifilm-unveils-new-cad-eye-function-for-colon-polyp-detection-.html Mon, 27 Sep 2021 12:15:00 +0530 Fujifilm India has launched a new software version of CAD EYE, a function that supports real-time detection of colonic polyps during colonoscopy utilising AI technology.   The updated function will be essential for colon polyp detection and characterisation, which will be achieved by utilising a type of Artificial Intelligence (AI) called deep learning. The launch was announced at the India Live Endoscopy Forum 2021.   The new detection and characterisation functionality of CAD EYE together with the polyp detection function will be available with software EW10-EC02 and the compatible expansion unit EX-1 in combination with Fujifilm’s ELUXEO systems and colonoscopes.   CAD EYE was originally developed to support real-time detection of colonic polyps utilising AI technology. When a suspicious polyp is detected within the endoscopic image, a Detection Box indicates the area where the suspicious polyp has been detected, accompanied by a sound signal.   The new CAD EYE Detection and Characterisation will assist clinicians by generating a suggested histological prediction by displaying whether the suspicious polyp(s) in the image are hyperplastic or neoplastic.           ]]> https://biospectrumindia.com/news/97/19591/insightec-bags-cdsco-approval-for-neurosurgery-platform-exablate-4000.html https://biospectrumindia.com/news/97/19591/insightec-bags-cdsco-approval-for-neurosurgery-platform-exablate-4000.html Mon, 20 Sep 2021 11:40:00 +0530 Israel and US-based Insightec has received market approval from the Central Drugs Standard Control Organization (CDSCO) for its incision-less neurosurgery platform, the Exablate 4000.   The Exablate 4000 (Exablate Neuro) platform uses MR-guided focussed ultrasound to precisely ablate a small target deep within the brain without incisions. The approval will enable the treatment of patients in India living with Essential Tremor, Tremor-dominant Parkinson's Disease and neuropathic pain.    "This approval adds to the growing recognition of the value of Focused Ultrasound for global healthcare systems," commented Maurice R Ferré MD, Insightec CEO and Chairman of the Board of Directors. "More importantly, expanded access to our technology is helping to transform the lives of people living with debilitating medical conditions."   "This technology offers appropriate patients immediate tremor control with a less invasive procedure that requires no incisions or anaesthesia with minimal complications," said Prof Paresh Doshi, Director of Neurosurgery, Jaslok Hospital and Research Centre and Group Advisor Functional Neurosurgery, Apollo Group of Hospitals, President of The Neuromodulation Society of India and Past President of the Indian Society for Stereotactic and Functional Neurosurgery. "Global clinical studies have demonstrated the procedure as approved is safe and helps patients to regain daily function." ]]> https://biospectrumindia.com/news/97/19576/co-diagnostics-jv-cosara-receives-cdsco-clearance-for-chikungunya-and-dengue-tests.html https://biospectrumindia.com/news/97/19576/co-diagnostics-jv-cosara-receives-cdsco-clearance-for-chikungunya-and-dengue-tests.html Fri, 17 Sep 2021 12:10:00 +0530 US-based Co-Diagnostics has announced that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization (CDSCO) in India to manufacture and sell its Saragene dengue and chikungunya RT-PCR tests as in vitro diagnostics (IVD).   The Saragene test kits approved by the CDSCO use the company's patented CoPrimer technology for the qualitative detection of these mosquito-borne viruses.   Mohal Sarabhai, Director, CoSara remarked, "We are pleased to be able to add two more products to our menu of diagnostics that can all be manufactured in India in agreement with the 'Make in India' initiative, as well as exported to help serve the needs of this region of the world which is highly burdened by the effects of these two diseases."   Dwight Egan, CEO, Co-Diagnostics, commented, "The first step in effective treatment of infectious diseases is an accurate diagnosis. Our highly specific CoPrimer technology is ideally suited to distinguish between similar diseases like dengue and chikungunya, and we believe that these tests have the potential to improve the lives of infected patients through more accessible and accurate diagnoses leading to better treatment."   CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C, human papillomavirus (HPV), and two COVID-19 assays, all to be manufactured and sold as IVDs in the Indian market. ]]> https://biospectrumindia.com/news/97/19572/medtronic-launches-robotic-assisted-surgery-platform-hugo-ras-system-in-india.html https://biospectrumindia.com/news/97/19572/medtronic-launches-robotic-assisted-surgery-platform-hugo-ras-system-in-india.html Thu, 16 Sep 2021 18:30:00 +0530 India Medtronic, a wholly-owned subsidiary of Medtronic, showcased its new robotic-assisted surgery platform, Hugo RAS system, at its state-of-the-art Surgical Robotics Experience Center (SREC), which was inaugurated in Gurugram.   The centre was inaugurated by Dr BK Rao, Chairman NABH, Chairman ASSOCHAM National Health Committee and Former Chairman- Board of Management at Sir Ganga Ram Hospital, Delhi in the presence of Chief Guest, Amitabh Kant, CEO, NITI Aayog.    Committed to delivering solutions that help surgeons and operating room staff achieve procedural and clinical proficiency, the SREC will focus on standardised training for surgeries with the Hugo RAS system.   The SREC is the company's first in the Asia Pacific and one of ten world-class facilities around the globe today where clinicians can experience and train on the Hugo RAS system.   The Hugo RAS system — Medtronic's solution to historic cost and utilisation barriers that have kept surgical robotics out of reach for many hospitals — is a modular, multi-quadrant platform designed for a broad range of soft-tissue procedures.   With the Hugo RAS system, Medtronic is building on its decades-long commitment to bring the benefits of minimally invasive surgery (MIS) to more patients around the world. With MIS, patients experience fewer complications, shorter hospital stays, and faster return to normal activities.      ]]> https://biospectrumindia.com/news/97/19563/entod-pharma-unveils-new-division-for-ophthalmic-surgical-needs.html https://biospectrumindia.com/news/97/19563/entod-pharma-unveils-new-division-for-ophthalmic-surgical-needs.html Wed, 15 Sep 2021 18:20:00 +0530 Mumbai headquartered ENTOD Pharmaceuticals has launched their super-speciality ophthalmic surgical division, 'HyTek' which caters to hi-tech solutions for ophthalmic surgical needs.   ENTOD's HyTek division will especially focus on the products which are required during ophthalmic surgical procedures like cataracts, refractive surgeries etc.   "The launch of the new division is expected to contribute an additional 5% growth in revenue initially and we’re expecting more with expansion,” said Executive Director of ENTOD Pharmaceuticals, Nikkhil K. Masurkar.    The HyTek division has been launched in Mumbai and subsequent extension plans are in progress for other metro and sub-metro cities. Through products manufactured at their state-of-the-art WHO GMP and US FDA approved manufacturing plants, ENTOD aims to provide innovative ophthalmic medicines in countries where there is an acute shortage of such formulations.    Masurkar further said, "ENTOD is a speciality pharmaceutical company however, our main focus has always been ophthalmology. We have huge expectations with the launch of this new division. It will allow us to strengthen ENTOD's collaboration with the large ophthalmic medical fraternity of India and around the world." ]]> https://biospectrumindia.com/news/97/19537/fujifilm-launches-project-to-verify-effectiveness-of-ai-based-diagnostics.html https://biospectrumindia.com/news/97/19537/fujifilm-launches-project-to-verify-effectiveness-of-ai-based-diagnostics.html Fri, 10 Sep 2021 13:15:00 +0530 Fujifilm Corporation has launched a project for verifying the effectiveness of its AI technology that assists diagnostic imaging in India as a new initiative in the company’s health screening service business for emerging countries.   This project will be conducted at the NURA, a health screening centre that Fujifilm opened in India in February this year. It has been selected as one of the 'Asia Digital Transformation Promotion Projects' by the Japanese Ministry of Economy, Trade and Industry in recognition of its potential in contributing to solving social issues in the fast-growing emerging countries in Asia.   In February this year, Fujifilm commenced its health screening service business in emerging countries and opened NURA, its first health screening centre focusing on cancer screening in Bengaluru. The centre has provided screening to people of all age groups, ranging from those in their 20s to 80s, including residents around Bengaluru and workers of nearby companies / medical facilities. Its ability to offer speedy and high-quality services have received high acclaim.   The latest project launched this time to be completed by January 2022, examines chest CT scan data of some 2,000 NURA visitors to verify that medical diagnosis based on the diagnostic imaging support function using AI technology can effectively prevent doctors from overlooking legions or improve the speed of interpreting images.  ]]> https://biospectrumindia.com/news/97/19526/truenat-test-kit-gets-dcgi-approval-for-nipah-diagnosis.html https://biospectrumindia.com/news/97/19526/truenat-test-kit-gets-dcgi-approval-for-nipah-diagnosis.html Wed, 08 Sep 2021 18:55:00 +0530 Truenat, an innovative point of care Real-Time PCR platform manufactured by Goa-based Molbio Diagnostics, has received Emergency Use Authorization by the Drugs Controller General of India (DCGI) for their Nipah test.   This is the first kit in India to receive regulatory approval to conduct tests for Nipah. Truenat is an indigenous portable, battery-operated and IoT-enabled point of care RT-PCR platform. Leveraging the large footprint of Truenat machines deployed across the country for diagnosis of infectious diseases such as TB, COVID-19, Hepatitis, etc., testing for Nipah Virus can now be performed rapidly, on demand and closer to the affected people, resulting in early and fast diagnosis for effective management of the disease and containment of the spread of the virus.  “The R&D work on the Truenat test for Nipah virus was first started in 2018 in collaboration with the National Institute of Virology, Pune (ICMR) to enable the detection of the infectious virus during outbreak situations. The ability to quickly deploy the platform to the point of need and the rapid testing capability makes it a powerful tool in the diagnosis and containment of the Nipah Virus. This collaboration with NIV allows us to react quickly in times of need such as emergencies,” said Dr Chandrasekhar Nair, Director & CTO, Molbio Diagnostics.   ]]> https://biospectrumindia.com/news/97/19498/trivitron-healthcare-unveils-portable-ultrasound-system-sonorad-k40.html https://biospectrumindia.com/news/97/19498/trivitron-healthcare-unveils-portable-ultrasound-system-sonorad-k40.html Fri, 03 Sep 2021 13:00:00 +0530 Trivitron Healthcare has recently launched a portable ultrasound system- SonoRad K40. The advanced and innovative portable Color Doppler ultrasound system is equipped with advanced technology and powered by RF ultrasonic metadata platform, a light, intelligent, and powerful tool to deliver a precise diagnosis.    The device is compact, fashionable, and it also fulfils the medical practice in the field of gastroenterology, obstetrics and gynaecology, cardiology, and point-of-care, and is also the best fit for routine scanning. The machine is portable and the colour mode offers accurate and efficient diagnosis and is used for a wide range of applications to assist medical practitioners for routine screening. The device offers a wide range of cardio-vascular applications for increased diagnostic confidence. It produces 2D, 3D images, Doppler performance, strain imaging, tissues Doppler imaging, and pulse wave technology in cardiology diagnosis.   The device offers a smart touch user interface that utilises the touch panel technology for easy operation and also allows rotation of 3D rendering images and comments. Multiprocessors allow simultaneous mode changes and support advanced system functionality.   The ultra-compact design allows it to be carried around with ease with a mobile cart that is also equipped with multiple probe connections. The device can also be connected with Wi-Fi, Bluetooth, and V cloud to streamline workflow.    The keyboard has an 8-inch capacity touch panel. It contains ergonomic hard keys for general ultrasound operations and contains 6 TGC slides, functionality at any depth. The display screen is 15.6 inches with high resolution, LED technology, with pixel resolution. It also has a big angel tilting capability.   ]]> https://biospectrumindia.com/news/97/19505/iit-d-opens-rapid-antigen-testing-facility-for-covid-19-.html https://biospectrumindia.com/news/97/19505/iit-d-opens-rapid-antigen-testing-facility-for-covid-19-.html Fri, 03 Sep 2021 13:00:00 +0530 A Rapid Antigen Testing (RAT) facility for COVID-19 was inaugurated at the Indian Institute of Technology, Delhi (IIT-D) recently by the Institute’s Director Prof V. Ramgopal Rao. The facility will be operated by JITM Skills, which will use the RAT kit developed by IIT-D. The test report will be available in 5-10 minutes. IIT-D beneficiaries will have to pay Rs. 50 for this test. The RAT kit, which has been developed by Prof. Harpal Singh from the Center for Biomedical Engineering, IIT-D is found to have a Sensitivity- 90%, Specificity- 100%, and Accuracy- 98.99% as certified by the Indian Council of Medical Research (ICMR). These are among the best available values for any such test kits in the world. There is already a RT-PCR sample collection facility on the campus for COVID-19 test, which uses the testing kit based on the technology developed by IIT-D researchers. ]]> https://biospectrumindia.com/news/97/19477/medtronic-establishes-surgical-skills-lab-in-srinagar.html https://biospectrumindia.com/news/97/19477/medtronic-establishes-surgical-skills-lab-in-srinagar.html Tue, 31 Aug 2021 12:00:00 +0530 Sher-I-Kashmir Institute Of Medical Sciences (SKIMS) and India Medtronic Private Limited, a wholly owned subsidiary of Irish firm Medtronic, have announced their partnership for a new Surgical Skill Lab at SKIMS. The lab was e-inaugurated by Chief Secretary UT, J&K, Dr. Arun Kumar Mehta (IAS) in the presence of Director SKIMS/EOSG, Dr. A.G Ahangar, Prashant Krishnan, Sr. Director, Surgical and ENT Therapies, Medtronic India and other key dignitaries. Expanding on its commitment to address capacity and awareness barriers, the Surgical Skill Lab will help in the training and development of young surgeons in the Union Territory of Jammu and Kashmir. The comprehensive surgical skills lab will feature endotrainers, laparoscopic suturing stations, airway management systems to help budding surgeons deepen their expertise in the surgical field. The lab aims to improve the skills of budding surgeons and provide an overall appreciation and understanding of minimally invasive surgery which in turn helps reduce burden on healthcare infrastructure with improved patient outcomes, reduced hospital stay, overall reduction in cost of hospitalization and faster recovery. ]]> https://biospectrumindia.com/news/97/19448/siemens-healthineers-unveils-molecular-diagnostic-kits-facility-in-vadodara-.html https://biospectrumindia.com/news/97/19448/siemens-healthineers-unveils-molecular-diagnostic-kits-facility-in-vadodara-.html Fri, 27 Aug 2021 18:20:00 +0530 Siemens Healthineers has announced local manufacturing of molecular testing kits, including COVID-19 testing (IMDX SARS-CoV2 Multiplex RTPCR) as well as other molecular testing kits at its state-of-the-art facility at Vadodara, Gujarat.   The facility was inaugurated jointly by Krishnan Seshan, Executive Director (Finance and Administration) of Siemens Healthcare and Arpan Malhotra, Head of Diagnostics, Siemens Healthineers, India.   "The kits are designed and developed by Siemens Healthineers along with researchers from Indian universities and research centers", said Arpan Malhotra.   The IMDX SARS-CoV2 Multiplex RTPCR kits will be produced in compliance with the guidelines prescribed by the Indian statutory bodies and conform to the highest global standards.    The existing manufacturing facility licensed as per Medical Device Rules, 2017 (MDR 2017), comprises of two product lines namely Urine Analysis strips and AUTOPAK Biochemistry Reagents.   As a part of the skill development initiative, the facility also serves as a Centre of Excellence for training in Laboratory Diagnostics, Point-of-Care Testing and Diagnostic Imaging, across the South Asia region. ]]> https://biospectrumindia.com/news/97/19444/manipal-hospitals-ushers-in-new-era-in-cancer-treatment.html https://biospectrumindia.com/news/97/19444/manipal-hospitals-ushers-in-new-era-in-cancer-treatment.html Thu, 26 Aug 2021 17:25:00 +0530 Manipal Hospitals has launched an advanced Radixact System with the Synchrony Automatic, Real-time Motion Synchronization technology, for the precise treatment of cancer patients.   Manipal Hospitals has obtained the requisite license from AERB for Radixact X9 Tomotherapy with Synchrony tumour tracking technology.   The Radixact system, with its new generation of tomotherapy with Synchrony technology, serves cancer patient needs, by far superior clinical results in head and neck, breast, GI and prostate cancers, which consolidate for more than 85 per cent of occurrence.   The system delivers 360 degrees rotational delivery for the whole body and CT based daily IGRT treatment with Iterative reconstruction. The combined technologies enable the delivery of radiation using a variety of methods — from image-guided intensity-modulated radiation therapy (IG-IMRT) to stereotactic body radiation therapy (SBRT) — to treat almost any tumour, even those that move with breathing, precision, accuracy and unprecedented flexibility.   Dr Vadhiraja B M, HOD & Consultant – Radiotherapy, Manipal Hospitals, Old Airport Road stated, “Synchrony for the Radixact System will provide clinicians with the technology they need to effectively and efficiently treat cancer patients requiring radiation therapy, in whom the tumour moves while breathing.”     ]]> https://biospectrumindia.com/news/97/19406/jehangir-hospital-launches-upgraded-centre-for-endoscopy-in-pune.html https://biospectrumindia.com/news/97/19406/jehangir-hospital-launches-upgraded-centre-for-endoscopy-in-pune.html Thu, 19 Aug 2021 13:00:00 +0530 Jehangir Hospital, Pune-based institution, has announced the launch of an upgraded endoscopy centre for early diagnosis of gastro-intestinal (GI) cancers, empowered by EUS, or Endosonography. With the advent of superior imaging technology in GI endoscopy, Jehangir Hospital added the latest instruments to position itself among the few institutions offering advanced GI care diagnosis. The upgraded Centre for Endoscopy at Jehangir Hospital includes the latest Exera 3 Video Endoscopy system with 190 series endoscopes which enable distinct advantages like dual focus, brighter and higher contrast Narrow Band Imaging and Improved image quality. These factors are invaluable in early diagnosis of GI cancers and classification of colonic and gastric polyps without biopsies. It also helps in diagnosing cancers at a very early stage, which can be usually cured without surgery. The new scopes also feature an integrated water jet channel helping the endoscopists to have a clearer view during haemostasis in actively bleeding patients or during complex therapeutic procedures.   Image caption- L to R: Dr. (Col) SS Gill - Medical Director; Cowas Jehangir - Trustee; Vinod Sawantwadkar - CEO; Dr. Sanjay Salunkhe; Dr. Parimal Lawate; Vayu Garware - MD, Garware; Dr. Lalit Shimpi; Mayuri Garware; Dr. Shilpa  Edathara ]]> https://biospectrumindia.com/news/97/19400/sai-life-sciences-opens-new-discovery-biology-facility-in-hyderabad.html https://biospectrumindia.com/news/97/19400/sai-life-sciences-opens-new-discovery-biology-facility-in-hyderabad.html Wed, 18 Aug 2021 17:35:00 +0530 Sai Life Sciences, a full-service contract research, development and manufacturing organisation (CRO-CDMO), has announced the opening of a new biology facility at its integrated R&D campus in Hyderabad.   The new state-of-the-art facility houses expanded in vitro and in vivo biology services, DMPK, toxicology and a vivarium. The facility augments both, its capabilities and capacity, to deploy cutting-edge platforms and technologies for accelerating integrated drug discovery programmes.   The new facility culminates the company's journey of unifying its discovery, early and late phase development and clinical supply capabilities in a single 13-acre campus housing over 1000 scientists, delivering integrated value at scale.   Krishna Kanumuri, CEO and MD, Sai Life Sciences, said, "The new facility marks the culmination of a journey we began two years ago, of creating differentiated value for our discovery clients through an integrated delivery model across Boston and Hyderabad. By bringing the best of talent, technology, complementary services and efficiency we are confident of bringing unique value to our clients and are keen to take on integrated discovery mandates, at scale." ]]> https://biospectrumindia.com/news/97/19399/wipro-ge-healthcare-unveils-first-ge-sonosim-simulation-coe-lab-in-navi-mumbai.html https://biospectrumindia.com/news/97/19399/wipro-ge-healthcare-unveils-first-ge-sonosim-simulation-coe-lab-in-navi-mumbai.html Wed, 18 Aug 2021 16:55:00 +0530 Wipro GE Healthcare launched its first-ever GE-SonoSim Simulation Centre Of Excellence (CoE) Lab in the South Asia Region at MGM Institute of Health Sciences, Navi Mumbai. SonoSimprovides scalable technology will train medical professionals and students in ultrasonography, using real patient cases spanning a broad spectrum of normal and pathologic conditions. The collaboration focuses on providing enhanced education services to medical professionals who aspire to learn ultrasonography from women’s health and cardiology to point of care and primary care. The SonoSimUltrasound Training Solution is a portable and comprehensive laptop-based ultrasound training platform that offers a curriculum of 60-plus cloud-based courses, image acquisition and interpretation training using the SonoSimulator and performance tracking respectively. The platform allows cases to be obtained from real patients for an on-demand, hands-on authentic scanning experience for ultrasound learning.Dr Shravan Subramanyam, Managing Director, Wipro GE Healthcare and President & CEO, GE Healthcare South Asia said, ‘’As ultrasound continues to grow across medical fields, clinicians must be properly trained on the systems to tend to their patients effectively and efficiently, particularly in critical situations.’’ ]]> https://biospectrumindia.com/news/97/19391/chennai-based-doc-develops-indias-first-3-d-printed-heart-valve.html https://biospectrumindia.com/news/97/19391/chennai-based-doc-develops-indias-first-3-d-printed-heart-valve.html Tue, 17 Aug 2021 16:50:00 +0530 Chennai-based Dr Sanjay Cherian has designed and developed India’s first 3D printed heart valve. A working prototype of the new 3D printed heart valve was recently displayed. The new 3D printed heart valve overcomes most of the disadvantages/complications associated with the currently available artificial heart valves that are in use today.The scientific innovation was undertaken in collaboration with the Centre for Automation and School of Mechanical Engineering, Vellore Institute of Technology (VIT), Chennai. “An added advantage of this 3D printed heart valve is that its design was developed using specialised computer-aided design software and modelling techniques, based on the MRI scan images of the human heart, as a result of which, we are now able to customise & 3D print heart valves that will fit exactly to the dimensions of the patient’s heart,” said Dr Sanjay Cherian.Dr Cherian added, "We are now in the process of patenting this 3D printed heart valve and testing it to confirm its bio-compatibility, efficacy and durability." ]]> https://biospectrumindia.com/news/97/19373/biher-to-set-up-state-of-the-art-diagnostics-research-centre-.html https://biospectrumindia.com/news/97/19373/biher-to-set-up-state-of-the-art-diagnostics-research-centre-.html Fri, 13 Aug 2021 12:00:00 +0530 Bharath Institute of Higher Education and Research (BIHER), based in Chennai, has successfully inked a “Mutual Understanding and Confidential Disclosure Agreement” (CCDA) with The Brigham and Women’s Hospital, (BWH) an affiliate of Harvard Medical School to set up world class cutting edge diagnostic research center. Expected to be setup with an overlap of $5 million, this will be the cutting edge facility rivalling the best in world in point of care diagnostics and mobile/tech enabled diagnostic devices. The CCDA signed between BIHER and BWH paves way for a formal engagement towards the joint development of a state of art research facility in medical, point of care, mobile based diagnostics. The applications of such a center are numerous: starting from detection of male infertility, ovulation, cancer and even viral loads which are critical as the current world is overwhelmed by COVID-19 pandemic. “This will bring together the two disciplines of engineering and medicine to conduct research and development in the field of biomedical application of 3D printing and medical device development,” said Dr. Suresh, Pro VC Research, from Bharath Institute of Higher Education and Research. ]]> https://biospectrumindia.com/news/97/19352/apollo-proton-cancer-centre-unveils-indias-first-robotic-oncology-unit.html https://biospectrumindia.com/news/97/19352/apollo-proton-cancer-centre-unveils-indias-first-robotic-oncology-unit.html Thu, 12 Aug 2021 12:35:00 +0530 Apollo Proton Cancer Centre (APCC) has launched a state-of-the-art dedicated robot-assisted cancer surgery unit. The robot-assisted cancer surgery unit will offer patients with comprehensive cancer care under one roof. The unit is equipped with the advanced fourth-generation ‘Da Vinci Surgical System-Xi’  and a dedicated team of clinicians. APCC offers specialised 360-degree care with the most advanced robotics system for complex surgeries. The robotic arms with EndoWrists have a 360+270 degree manoeuvrability which is unmatched by the human hand. The advancement improves recovery from major operations, reduces instances of infections, increases the precision of surgery and reduces the patient’s length of stay at the facility.  The robot helps replicate the surgeon’s hand movements while minimising hand tremors. The surgery is thus conducted with enhanced precision, dexterity, and control even during the most complex procedures. The technology provides the surgeon with a 10x magnified, high definition, the 3D image of the body's intricate anatomy. The controls in the console allow the surgeon to manipulate special surgical instruments that are smaller, as well as more flexible and manoeuvrable than the human hand. The surgeon is thus in complete control of the surgical procedure.Dr Prathap C Reddy, Chairman Apollo Hospitals, said, “The robot-assisted surgery has its advantage compared to the open or laparoscopic surgeries." ]]> https://biospectrumindia.com/news/97/19338/iit-d-aiims-co-develop-telerobotic-ultrasound-system.html https://biospectrumindia.com/news/97/19338/iit-d-aiims-co-develop-telerobotic-ultrasound-system.html Tue, 10 Aug 2021 17:00:00 +0530 A research collaboration between the Indian Institute of Technology Delhi (IIT-D) and the All India Institute of Medical Sciences (AIIMS), New Delhi has jointly developed a Telerobotic Ultrasound System. The system allows remote ultrasound access through a robotic arm. In the routine ultrasound setting, the doctor (Radiologist) stands in close contact with the patient for the entire scan duration. However, cross-sectional imaging is preferred instead in the current pandemic scenario with stringent social distancing requirements – a more expensive and less dynamic technique. Ultrasonography is a non-invasive, non-ionizing, cost-effective, rapid, bedside, and readily available modality with immense use in point-of-care and follow-up examinations. Dr. Chandrashekhara, AIIMS, New Delhi said, “This system will promote healthcare and make our system more prepared for further pandemics. Besides its role in the pandemic, it will allow a better outreach of ultrasound imaging to remote rural areas of India.  The control architecture had been developed to teleoperate the ultrasound probe attached to the robotic arm while ensuring the patient’s safety and the quality of ultrasound images. ]]> https://biospectrumindia.com/news/97/19329/mylab-hemex-health-ink-tech-partnership-for-poc-diagnostics-.html https://biospectrumindia.com/news/97/19329/mylab-hemex-health-ink-tech-partnership-for-poc-diagnostics-.html Mon, 09 Aug 2021 19:20:00 +0530 Pune-based startup Mylab Discovery Solutions has joined forces with the US-based Hemex Health, a medical diagnostic device company focused on creating life-changing global health products, to develop next-generation diagnostic solutions for the Point-of-Care (POC) testing of coronavirus and other diseases.   Under the technology partnership, Mylab will develop test assays and Hemex will provide its Gazelle POC testing platform and expertise.   The portable diagnostic device and tests assays will help in testing at any location, in a wide range of environmental conditions, and without the need to transport the sample, enabling quick results for the patients.   Together, the companies will develop Fluorescence Immunoassay (FIA) and Electrophoresis-based diagnostic solutions. These tests are more sensitive than the normal rapid antigen tests and have fewer false negatives. The diagnostic solution will be jointly introduced in the international markets including the US, Europe and Asia.   Commenting on the partnership, Hasmukh Rawal, MD, Mylab Discovery Solutions, said, “Together with Mylab’s accurate FIA test kits, we can make testing available anywhere – from a small village without electricity to an international airport. We believe this partnership will help India and the world prevent subsequent waves of coronavirus”.   The companies expect the first product from this technology partnership to be launched by November 2021.   ]]> https://biospectrumindia.com/news/97/19310/trivitron-launches-sonorad-v60-ultrasound-with-modern-intelligent-system.html https://biospectrumindia.com/news/97/19310/trivitron-launches-sonorad-v60-ultrasound-with-modern-intelligent-system.html Fri, 06 Aug 2021 11:10:00 +0530 Trivitron has recently launched SonoRad V60 Ultrasound devoted to delivering excellent imaging systems and exceptional image quality. SonoRad V60 is equipped with modern intelligent system and smart solution design to deliver high-quality care to patients. Trivitron SonoRad V60 imaging ultrasound machines are equipped with comprehensive image processing tools which lead to superior and consistent image quality. The product also offers VLucid platform, built with sophisticated image processing technologies with advanced intellectual tools and offer an efficient workflow for a wide range of applications.The device is equipped with innovative colour flow technology that improves blood flow visualisation and offers 3D-like flow impression. The increased processing of the colour doppler provides more diagnostic confidence with improved blood flow detection and enhanced colour performance. The vascular anatomy visualisation and flow within the blood vessels are also increased. SonoRad V60 is provided with a high-performance hardware architecture that offers excellent penetration using 25MHz high-resolution system capability. It helps add more than 30 per cent wideband frequencies that offer a better diagnosis as it improves the resolution. ]]> https://biospectrumindia.com/news/97/19285/healthium-acquires-abgel-to-strengthen-portfolio-in-surgical-and-post-surgical-care.html https://biospectrumindia.com/news/97/19285/healthium-acquires-abgel-to-strengthen-portfolio-in-surgical-and-post-surgical-care.html Tue, 03 Aug 2021 10:30:00 +0530 Healthium, a global player in medical devices, has acquired AbGel gelatin sponge business from Mumbai-based Shri SGK Labs, adding to its product portfolio focused on surgical and post-surgical care.   Earlier this financial year, the company had acquired VitalCare Group in the UK to grow its urology portfolio and expand its market in Europe and the US.   Bengaluru-based Healthium aims to further expand the market access of this portfolio using its wide network of hospitals across India.   AbGel is an absorbable gelatin sponge, manufactured from highly purified neutral gelatin with haemostatic capabilities and is designed to control blood oozing in instances of haemorrhage from multiple small vessels, and is completely absorbed in four to five weeks with no residue or encapsulation. It is non-toxic, non-allergic, non-immunogenic and non-pyrogenic.    AbGel is beneficial in effectively managing this across a wide variety of specialities including abdominal surgery, neurosurgery, gynaecological surgery, ENT surgery, dental surgery and oncosurgery.    Speaking on the acquisition, Anish Bafna, CEO and MD, Healthium Medtech, said, “Hemostasis during surgical procedures is an area of concern for surgeons. We are excited to add a brand like AbGel that is a recognised brand in the gelatin sponge category and has been contributing to safer surgeries for over four decades. This acquisition strengthens our presence in the category and our commitment to drive value for our customers.”        ]]> https://biospectrumindia.com/news/97/19270/fujifilm-india-yashoda-hospital-set-up-coe-for-pulmonologists-in-hyderabad.html https://biospectrumindia.com/news/97/19270/fujifilm-india-yashoda-hospital-set-up-coe-for-pulmonologists-in-hyderabad.html Fri, 30 Jul 2021 14:40:00 +0530 Fujifilm India recently inaugurated its state-of-the-art Center of Excellence in collaboration with Yashoda Hospital in Hyderabad. The inaugural event focussed on highlighting Fujifilm’s association with Yashoda Hospital to create a first-of-its-kind training platform for pulmonology speciality in India. With this, the company is aiming at educating and offering training to clinicians in endoscopy and serve society with better healthcare and diagnosis.    At the centre, Fujifilm will offer adequate training to doctors and enable them to detect early growth in the lungs, sample the tissue/node, targeted biopsy and treat them timely resulting in a reduced spread of the disease.   They will additionally be able to diagnose mediastinal nodes and conduct ultrasound-guided fine needle aspiration cytology (FNAC) to rule out the confusion between diagnosis of sarcoidosis and lung tuberculosis with the help of endobronchial ultrasound (EBUS) system.    Koji Wada, MD, Fujifilm India said, “With our collaboration with Yashoda Hospital, Hyderabad, we have taken a step ahead to offer comprehensive facilities and advanced technology that will help in the timely detection of the disease. Our centre will enhance knowledge, skills, procedures, and create a more satisfactory experience for the patients."   The centre will provide a plethora of course options to clinicians ranging from Basic Bronchoscopy Simulation Certification to EBUS Simulation Certification. Other offered courses are, Advanced Bronchoscopy Simulation Certification, Pediatric Bronchoscopy Simulation Certification and Navigation Bronchoscopy Simulation Certification.    ]]> https://biospectrumindia.com/news/97/19263/clinirx-bags-cro-partner-accreditation-from-medidata-rave-edc.html https://biospectrumindia.com/news/97/19263/clinirx-bags-cro-partner-accreditation-from-medidata-rave-edc.html Fri, 30 Jul 2021 11:10:00 +0530 CliniRx has achieved accreditation as a CRO partner for Medidata Rave EDC, joining Medidata's industry-leading partner programme to further advance its technical and operational performance. CliniRx can now offer the full suite of Rave EDC and clinical data management (CDM) services to sponsors. Part of the Medidata Clinical Cloud, Rave EDC (electronic data capture) is an advanced and robust system for capturing, managing and reporting clinical research data.   CliniRx is a full-service global CRO (contract research organization), conducting multinational clinical trials for pharma, biotech, and medical devices companies. CliniRx's staff have undergone rigorous accreditation processes by Medidata and are fully trained to take on a variety of complex clinical data management projects. Through this partnership, CliniRx has filled the gaps on the supply side of the market with Medidata's industry-leading solution.   "Attaining the Medidata Rave EDC accreditation demonstrates our dedication to bringing high-end solutions with optimal efficiencies to our customers for clinical trials across all study phases and therapeutic areas," said Shiv Issar, Head, CliniRx.    "We can guide sponsors through every aspect of the database build to ensure best data management practices are employed. We are confident that in aligning with industry leaders like Medidata, we can deliver quality data that our customers trust. We view this accreditation and partnership milestone as a continuing investment in our technologies that help us to bring the highest level of value to our customers," Issar added.   "CliniRx's dedication and expertise enabled them to achieve Medidata Rave EDC accreditation within a short timeline," said Edwin Ng, Senior Vice President, General Manager, APAC, at Medidata. "Their customers can now benefit from Medidata's scalable unified platform, which adapts as needed across the global ecosystem. We are excited to evolve our partnership with the CliniRx team as they further enhance the value they bring to their customers."   Medidata is a wholly-owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalised medicine with the first end-to-end scientific and business platform, from research to commercialisation. ]]> https://biospectrumindia.com/news/97/19229/spicehealth-launches-first-mobile-testing-lab-in-guwahati-.html https://biospectrumindia.com/news/97/19229/spicehealth-launches-first-mobile-testing-lab-in-guwahati-.html Mon, 26 Jul 2021 12:05:00 +0530 SpiceHealth has launched its first mobile testing laboratory in Guwahati to conduct Real-Time Polymerase Chain Reaction (RT-PCR) and Rapid Antigen tests.   The company’s mobile lab will be stationed at the Indira Gandhi Athletic Stadium whereas the sample collection set-up will be at Lokpriya Gopinath Bordoloi International Airport.    The company has partnered with National Health Mission, Assam to set up the facility in Guwahati and will conduct testing at the airport and nearby districts.   SpiceHealth operates 23 labs and collection centres spread across ten cities in India. The company operates seven vaccination centres in five states.   Avani Singh, CEO, SpiceHealth said, “As part of our commitment towards ramping up Covid testing across the country to control the spread of the pandemic, SpiceHealth has launched its first mobile RT-PCR and Rapid Antigen testing laboratory in Guwahati. With the recent launch of our mass vaccination exercise and presence of mobile testing laboratories across India’s worst-affected regions, SpiceHealth is steadily inching towards its pan-India presence ensuring public healthcare driven by innovation and affordability.”     ]]> https://biospectrumindia.com/news/97/19215/medtronic-launches-percept-pc-deep-brain-stimulation-system-in-india.html https://biospectrumindia.com/news/97/19215/medtronic-launches-percept-pc-deep-brain-stimulation-system-in-india.html Fri, 23 Jul 2021 11:35:00 +0530 India Medtronic has launched the Percept PC Deep Brain Stimulation (DBS) system. The system enabled with BrainSense technology is designed to capture brain signals while simultaneously delivering therapeutic stimulation, inside and outside the clinic. Ergonomically designed, the Percept PC device offers enhanced comfort and is indicated for patients with Parkinson’s disease, tremor, dystonia, and epilepsy.   DBS therapy for movement disorders has gained acceptance and widespread clinical use in recent years.   DBS is an individualised therapy delivered from a small pacemaker-like device, placed under the skin of the chest or abdomen, to send electrical signals through very thin wires (leads) to a targeted area in the brain related to the symptoms of a neurological disorder.   “With Percept PC, physicians can now track patient brain signals and correlate these with patient-recorded actions or experiences such as symptoms, side effects, or medication intake. This allows for more personalised, data-driven neurostimulation treatment. Medtronic is working towards devising meaningful innovations that harness the power of data to improve overall care and efficiency,” said Rahul Arora, head of Neurosciences Therapy, Medtronic India. ]]> https://biospectrumindia.com/news/97/19186/redcliffe-life-diagnostics-launches-four-new-labs.html https://biospectrumindia.com/news/97/19186/redcliffe-life-diagnostics-launches-four-new-labs.html Mon, 19 Jul 2021 15:15:00 +0530 Redcliffe Life Diagnostics, a unit of Redcliffe Lifetech US and India, recently launched four new labs in Patna, Indore, Raipur and Noida. The four new labs are part of the larger expansion at Redcliffe Pathology portfolio. Additionally, three new labs are planned to go operational every month.    Dheeraj Jain, Founder, Redcliffe Life Diagnostics said, "With this expansion drive, Redcliffe Life Diagnostic aims to raise awareness about its services and established a widespread awareness for preventive healthcare in the country. The company is working with the belief that proper diagnosis can be a major tool to narrow the healthcare gap between rural and urban India. We started home collection last year and are now launching labs in various cities in the next 12 months to offer last-mile service delivery.”   ]]> https://biospectrumindia.com/news/97/19165/us-firm-cue-health-receives-approval-in-india-for-point-of-care-covid-19-test.html https://biospectrumindia.com/news/97/19165/us-firm-cue-health-receives-approval-in-india-for-point-of-care-covid-19-test.html Wed, 14 Jul 2021 20:00:00 +0530 Cue Health Inc., a healthcare technology company in the US, has announced it has received regulatory approval from The Central Drugs Standard Control Organisation (CDSCO) for the Cue COVID-19 Test for professional point-of-care use in India. Internationally, Cue has also received the CE mark in the European Union (EU), as well as Interim Order authorization from Health Canada. Cue's easy-to-use, portable COVID-19 test provides highly accurate, lab-quality results – including detection of emerging variants – directly to connected mobile smart devices in about 20 minutes, and Cue's natively digital platform allows for end-to-end integrated reporting of test results. Cue expects to enable end-to-end care journeys from diagnostic tests to physician consultation via telemedicine through intervention. The Cue Health Monitoring System is designed to deliver a broad menu of tests through one system. Cue plans to develop a suite of offerings to address respiratory health, sexual health, cardiac and metabolic health, women's health, men's health, and chronic disease management by connecting diagnostics with telemedicine. ]]> https://biospectrumindia.com/news/97/19157/siemens-healthineers-installs-biomatrix-3t-mr-system-at-rgcirc-.html https://biospectrumindia.com/news/97/19157/siemens-healthineers-installs-biomatrix-3t-mr-system-at-rgcirc-.html Wed, 14 Jul 2021 11:50:00 +0530 Rajiv Gandhi Cancer Institute and Research Centre (RGCIRC) has installed BioMatrix 3T MR System from Siemens Healthineers named MAGNETOM Vida. This is the first BioMatrix System installed in Delhi and NCR region and is most suited for cancer imaging. BioMatrix technology will help to overcome imaging challenges by automatically adjusting to patient biovariability. “We are confident that the recent Installation of MAGNETOM Vida will certainly set a new benchmark in oncology imaging and this would help us deliver individualised and personalised care to all our patients with the help of BioMatrix technology. We had some challenges with scanning patients with limited breath-hold capability. New revolutionary free breathings abdomen examination has brought in a new paradigm shift in abdomen screening with high-resolution dynamic abdominal imaging under free-breathing with one continuous, push-button exam. New and Unique 64 channel Head Neck coil can now help us in improving our clinical results and speed by multifold," said Dr Arvind K Chaturvedi, Chair Radiology and Interventional Oncology, RGCIRC.“MAGNETOM Vida effectively combines a unique Biomatrix technology which adapts automatically to bio-variability that enables personalised examinations and helps expand precision medicine. Coupled with an AI-based Dot engine it provides precise automated planning. New advanced platform and turbo packages help in performing scans up to 50 per cent faster compared to any conventional scanners,” said Subodh Divgi, Head of MRI business, Siemens Healthineers, India. ]]> https://biospectrumindia.com/news/97/19152/neuberg-diagnostics-opens-lab-in-telangana.html https://biospectrumindia.com/news/97/19152/neuberg-diagnostics-opens-lab-in-telangana.html Tue, 13 Jul 2021 17:05:00 +0530 Chennai headquartered Neuberg Diagnostics has opened a pathology lab in Khammam, Telangana. The new lab was inaugurated by Puvvada Ajay Kumar, Minister of Transport, Government of Telangana, Errabelli Dayakar Rao, Minister of panchayat Raj & Rural Development, Telangana.    The group had closed FY 21 with gross revenue of Rs 800 crores. As a part of the expansion plan in FY22, Neuberg will be launching 30 new labs and more than 500 collection centres in domestic and international markets.   It will also be putting up technology incubation centres in the US and Europe to access the latest technologies and make developing countries ready for precision diagnostics in the evolving personalised medicine arena.   A Ganesan, Group Vice Chairman, Neuberg Diagnostics said, “Apart from inorganic growth, we are also setting up greenfield labs and mobile COVID testing units to increase the reach of quality testing in small towns in India. In terms of international expansion, we are looking to expand rapidly in the US and also planning to open diagnostics facilities in East Africa and West Asia. We will be commissioning a new testing facility in Dubai which will act as a hub in West Asia. We are also planning to have our presence in Sri Lanka, Nepal, Bangladesh and Germany in this financial year."     Currently, Neuberg Diagnostics has 109 labs in India and 15 labs overseas (the US, South Africa, and Dubai). With 14 approved labs for covid testing in India, the group can process more than 65000 tests per day. Additionally, the group is also doing COVID tests from three of its labs in South Africa and one in the US.   ]]> https://biospectrumindia.com/news/97/19140/abbott-introduces-panbio-covid-19-antigen-self-test-in-india.html https://biospectrumindia.com/news/97/19140/abbott-introduces-panbio-covid-19-antigen-self-test-in-india.html Mon, 12 Jul 2021 15:40:00 +0530 Abbott has launched Panbio COVID-19 Antigen Self-Test for the detection of the SARS-CoV-2 virus in adults and children with or without symptoms. Self-test kits are offered in packages of one, four, 10 and 20 tests. With results in just 15 minutes, the Panbio COVID-19 Antigen Self-Test enables people who test positive to immediately isolate so that they do not infect others, rather than waiting days for results. The test is to be used along with Abbott’s NAVICA mobile app, available in the Google Play and Apple app store. The app offers a simple and streamlined process of self-registration, automatic reading of results and easy reporting as per ICMR guidelines. Panbio Self-Tests will be available via retail pharmacies and through e-commerce platforms, as well as through organisations and institutions.The Panbio professional test demonstrated 95.7 per cent sensitivity and 97.6 per cent specificity when benchmarked against RT-PCR tests, indicating high reliability. Panbio has CE Mark for asymptomatic use and supervised nasal swab collection and is on the World Health Organization (WHO) Emergency Use Listing.Also available is Abbott’s ID NOW system, a molecular point-of-care test the size of a toaster that's designed to deliver results in less than 15 minutes. ID NOW is being widely being used at airports, emergency departments, diagnostics laboratories and in a wide variety of other point-of-care settings.  ]]> https://biospectrumindia.com/news/97/19125/virtual-workshop-on-cgmps-in-indian-medical-devices-held.html https://biospectrumindia.com/news/97/19125/virtual-workshop-on-cgmps-in-indian-medical-devices-held.html Fri, 09 Jul 2021 16:15:00 +0530 The fourth of a series of six virtual workshops on current Good Manufacturing Practices to support the Indian pharmaceutical / Medical Devices industry’s vision of providing world-class quality medical products was inaugurated by Dr Renu Swarup, Secretary, Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India.    The initiative is the result of an active collaboration between the Union Ministry of Health & Family Welfare (MoHFW), Department of Biotechnology (DBT), Ministry of Science and Technology, the World Health Organization (WHO), JSS Academy of Higher Education & Research at Mysuru (JSS AHER), AMTZ and the Indian Pharmaceutical Alliance (IPA).   Dr Swarup said, “This initiative of providing the requirements of Global standards meets the critical need of enabling further up-gradation of in vitro diagnostics and medical devices sector for achieving global standards of quality. This will have a far-reaching positive impact. It reiterates our commitment to quality medical products.”    Welcoming the capacity-strengthening workshops, Dr VG Somani, Drug Controller General of India, said, “We are committed to the highest regulatory standards to ensure quality, safety and efficacy of medical products. This workshop conducted by a team from WHO PQ IVD Assessment team would support Indian medical devices units to upgrade their quality culture to global standards.”    “The virtual workshop for medical devices units is a key step in that direction, and we are delighted to partner in this path-breaking programme,” said Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance.    National and international experts, including from WHO (HQ, Regional Office for South-East Asia, Country Office for India) and leading industry voices came together to design a need-based workshop programme.    Dr Jitendra Sharma, Managing Director & CEO, Andhra Pradesh Med Tech Zone (AMTZ) said that the workshop would propel the Indian medical devices industries to higher global standards.   Shirish Belapure, Senior Technical Advisor, at Indian Pharmaceutical Alliance, said, “IPA Quality forum has one prime objective of upgrading the quality of Indian pharmaceuticals and medical devices industries and this workshop is supporting the realisation of the same.”   Dr Anup Anvikar, Director, National Institute of Biologicals (NIB), Veena Kohli, President, Association of Diagnostics Manufacturers of India (ADMI) and Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) also graced the occasion.   ]]> https://biospectrumindia.com/news/97/19107/metropolis-healthcare-haystackanalytics-launch-nextgen-tb.html https://biospectrumindia.com/news/97/19107/metropolis-healthcare-haystackanalytics-launch-nextgen-tb.html Wed, 07 Jul 2021 15:35:00 +0530 Metropolis Healthcare has launched NEXTGEN TB, whole-genome sequencing of tuberculosis utilising the Next Generation Sequencing (NGS) platform for rapid identification of drug resistance in TB patients and providing genotypic level information on drug-resistant genes for up to 18 Anti - TB antibiotics.   Partnering with HaystackAnalytics (start-up incubated at SINE, IIT Bombay), Metropolis Healthcare plans to offer this test in Sri Lanka, Mauritius, the UAE, Kenya, Zambia, Ghana, Tanzania as well as three other African countries to help their fight against tuberculosis.   The 18 drugs covered are Streptomycin, Isoniazid, Rifampicin, Ethambutol, Pyrazinamide, Kanamycin, Amikacin, Capreomycin, Ofloxacin, Moxifloxacin, Gatifloxacin, Ethionamide, Para-amino salicylic acid, Linezolid, Clofazimine, Bedaquiline, Pretomanid, and Delaminid.   NEXGEN TB has a better turnaround time with much faster and reliable results. Additionally, any novel drug resistance genetic mutations can be identified by whole-genome sequencing using NGS.   Ameera Shah, Promoter and MD, Metropolis Healthcare, “It’s an honour to partner with homegrown start-up, HaystackAnalytics to help launch NEXTGEN TB, as its need has become essential to this world. With TB being around long enough for everyone to know how lethal it could be, it is a sheer moment of pride to be able to launch such a test as we hope this could help us cope through the silent pandemic which has been smouldering against us for so many years.”   Dr Niranjan Patil (MD, Microbiology), Scientific Business head- Infectious diseases, Microbiology & Molecular biology- Head & Biosafety officer, Metropolis Healthcare said, “Whole-genome sequencing-based tests such as Nextgen TB not only identifies the TB species involved & in one go it helps reduce the time for performing anti TB drug susceptibility from weeks to just seven to 10 days thus saving crucial time for initiation of evidence-based treatment regimens as well as complementing the TB culture-based tests. It also helps to identify any novel mutations responsible for TB drug resistance which is an added advantage." ]]> https://biospectrumindia.com/news/97/19098/pathstore-france-unveils-rt-pcr-testing-service-in-india-at-rs-299.html https://biospectrumindia.com/news/97/19098/pathstore-france-unveils-rt-pcr-testing-service-in-india-at-rs-299.html Tue, 06 Jul 2021 15:15:00 +0530 PathStore France has launched COVID-19 RT-PCR testing campaign ‘Abki Baar RT-PCR’. The company is all set to bring about a revolutionary market correction within the diagnostic industry. The company is offering the test at Rs 299.   PathStore’s deployment of its highly affordable ‘gold standard’ RT-PCR testing will be a key part of the state’s response in ensuring tourism, industrial and retail sectors functioning. The company has projected overall savings of over $2 to $5 billion a year to the exchequer if the testing rates are brought down nationally.   Talking about the overall campaign, Anubhav Anusha, Global CEO, GeneStore said, “The PathStore COVID-19 test will be a major shot in the arm to the Indian and global testing strategies in the fightback against COVID-19. At present, India is conducting 15 to 20 lakh tests per day, which on average costs the Indian economy close to Rs 3000 crores a month. With the price point of Rs 299, it is estimated that the Indian consumer will save over Rs 1500 crores per month, which translates into a sufficient fund to procure approximately an additional one crore vaccines monthly or at least double the scale of testing.”      The company has established three testing laboratory, which is capable of handling one lakh samples a day, and will be led by an army of 500 medical representatives trained by Mayo Clinic, USA.   The company has also launched an Allied Medical Services Training Academy to address the issue of India’s manpower crisis for COVID 19 RT PCR sample collection and is currently training over 1000 individuals as a part of its nationwide human resources deployment to fight the pandemic.   Earlier in 2020, PathStore’s parent company GeneStore France in Joint Venture with SpiceHealth launched the RT-PCR mobile laboratories with Rs 499 testing service. GeneStore has exited the Joint Venture partnership with SpiceHealth in January 2021. ]]> https://biospectrumindia.com/news/97/19083/eqt-private-equity-and-goldman-sachs-to-buy-parexel-for-8-5-b.html https://biospectrumindia.com/news/97/19083/eqt-private-equity-and-goldman-sachs-to-buy-parexel-for-8-5-b.html Fri, 02 Jul 2021 16:00:00 +0530 Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance patient health, has announced the execution of a definitive merger agreement under which it will be acquired by EQT IX fund (EQT Private Equity) and the Private Equity business within Goldman Sachs Asset Management (Goldman Sachs) from Pamplona Capital Management LP for $8.5 billion. “Over the past 18 months Parexel has continued its strong growth trajectory delivering on its patients-first focus and accelerating new therapies to patients in need around the world,” said Parexel CEO Jamie Macdonald. “With the market for outsourced clinical research services anticipated to grow at a conservative CAGR of 8 to 9 percent, our focus remains on advancing and innovating Parexel to meet our customers’ needs across the evolving clinical development landscape. EQT and Goldman Sachs support this vision and are committed to investing in Parexel and our people to capitalize on this exciting market opportunity and make a difference for patients.” The transaction is subject to customary conditions, including receipt of applicable regulatory approvals. Evercore acted as the financial advisor to Parexel, and Kirkland & Ellis LLP provided legal counsel in connection with the transaction. Goldman Sachs and Jefferies LLC acted as financial advisors to EQT Private Equity and Goldman Sachs Asset Management, and Simpson Thacher & Bartlett LLP provided legal counsel in connection with the transaction. ]]> https://biospectrumindia.com/news/97/19077/max-super-speciality-hospital-vaishali-installs-da-vinci-xi.html https://biospectrumindia.com/news/97/19077/max-super-speciality-hospital-vaishali-installs-da-vinci-xi.html Fri, 02 Jul 2021 13:25:00 +0530 Max Super Speciality Hospital, Vaishali announced the installation of the latest in robot-assisted surgery technology, Da Vinci Xi, by US-based Intuitive. By using this technology, Dr Anant Kumar (Chairman, Urology, Robotics & Renal Transplant, MSSH Vaishali) and Dr Vimal Dassi (Associate Director – Urology, Robotics, Kidney Transplant and Uro-Oncology) at MSSH Vaishali successfully performed the first-ever robotic kidney transplant in Uttar Pradesh.   The procedure was carried out on the 27-year-old female recipient, a resident of Noida, Uttar Pradesh, with minimal muscle cuts, reducing pain and blood loss as the incision was only 6 to 7 cms compared to 20-25 cm long incisions in the normal transplants. The Da Vinci surgical system was used in the procedure, allowing the tremor-free movement of the instruments. As a result, there was no damage to the graft kidney, ensuring swift recovery.    Dr Kumar, said, "We are happy to bring robotic surgery in kidney transplants in UP for the first time. We hope that this is a good start to robotic surgeries in the state, and this will go a long way in availing new age surgical technology for people in this part of the country without having to travel to nearby metros like Delhi”.   Commenting on this installation, Dr Gaurav Aggarwal, Senior Vice President – Operations; Max Hospital Vaishali, said, "The installation will help to get better clinical outcomes in kidney surgeries, urological reconstructive surgeries, gallbladder removal, prostate removal, bariatric surgery, abdominal wall reconstruction, fibroids removal, urinary incontinence, thoracic surgery, ENT surgery as well."   Dr Vivek Bindal, Associate Director & Head – Institute of Minimal Access, Bariatric & Robotic Surgery, MSSH, Vaishali said, " In another ventral hernia case, a 44-year-old patient could travel back home in 48 hrs, as the abdominal wall reconstruction for this patient was done with just 8 mm incisions by using da Vinci Xi technology.”   These benefits go a long way in enabling the surgeon and care teams in providing life-enhancing care for patients. For example, in the recent prostate cancer surgery performed by Dr Puneet Ahluwalia (Principal Consultant – Surgical (Uro)Oncology, Max Institute of Cancer Care, Vaishali), the 52-year-old patient could get discharged and get back to his everyday life within 24 hours.    Mandeep Singh Kumar, VP&GM- Intuitive India, said, "It gives us great pleasure to expand our association with Max healthcare, this being our fourth installation at Max group of hospitals. The installation of the da Vinci system at the Max Vaishali centre serves as a testament to the growing trust our customers have in the ingenuity of our technology." ]]> https://biospectrumindia.com/news/97/19076/jawaharlal-nehru-centres-researchers-develop-oxyjani-.html https://biospectrumindia.com/news/97/19076/jawaharlal-nehru-centres-researchers-develop-oxyjani-.html Fri, 02 Jul 2021 10:45:00 +0530 Indian researchers have designed a robust, mobile group oxygen concentrator that can be used in rural settings and also be rapidly deployed in emergencies in any location. A team from Jawaharlal Nehru Centre for Advanced Scientific Research, an autonomous institute under the Department of Science & Technology, Government of India, developed a new solution with the name ‘OxyJani’ for addressing these novel challenges in adsorption science and engineering.    OxyJani is based on the principles of Pressure Swing Adsorption (PSA) technology. The team replaced lithium zeolites (LiX) which is usually used in oxygen concentrators, with sodium zeolites which does not generate toxic solid waste and can be manufactured in India.    Although the science behind it is well understood, developing an engineering solution that can work with sodium in a portable device and fill this specific market gap when there are severe sourcing problems posed engineering challenges. Obstacles had to be overcome at each stage of the cycle, from working with the available zeolites to effective ways of dehumidifying and designing the right adsorption-pressure cycle.   The concentrator is modular and capable of delivering a range of solutions, conversion of medical air to medical oxygen, and is an entirely off-grid solution including all modules that can facilitate deployment in rural areas. Moreover, the waste from the 13X zeolite plant can be potentially a good agricultural input material.   In this multi-group initiative, Dr SV Diwakar, Dr Meher Prakash, Professor Santosh Ansumali from JNCASR, and collaborators, Professor Arvind Rajendran from the University of Alberta and Arun Kumar (Eiwave Digitech) executed the OxyJani developmental efforts with the help of Ritwik Das (MS student). Technical advice was provided by Prof M Eswaramoorthy, Prof Tapas Maji, and Prof Sridhar Rajaraman. Professor G. U. Kulkarni, President, JNCASR and Professor Amitabha Bandyophyay of IIT Kanpur mentored developmental efforts. The financial assistance for the prototype was provided through JNCASR and the Nidhi Prayaas scheme of IIT Kanpur. The zeolite material was obtained through a generous donation from Honeywell UOP, Italy.    This new class of technology called “group concentrators” has the robustness of large PSA plants, portability similar to the personal concentrators, and is affordable too. The device is in the range of 30-40 lpm, which is potentially useful for ICU uses too.  ]]> https://biospectrumindia.com/news/97/19072/molbio-diagnostics-opens-new-manufacturing-unit-in-goa.html https://biospectrumindia.com/news/97/19072/molbio-diagnostics-opens-new-manufacturing-unit-in-goa.html Thu, 01 Jul 2021 17:00:00 +0530 Molbio Diagnostics has launched a new manufacturing unit for its innovative molecular diagnostic platform - Truenat Real-Time PCR, spread across 1,35,000 Sq.ft, in Verna, Goa. The new manufacturing unit was launched in the backdrop of increasing demand for point-of-care molecular testing, in India and across the world, to meet the critical need for reliable technologies that can enable early and accurate diagnosis. The new facility will increase the existing production capacity to 3.5 lakh units per day, thus strengthening indigenous production capacity and ensuring the uninterrupted availability of Truenat test kits. On the occasion of the launch, Sriram Natarajan, Director & CEO of Molbio Diagnostics, said, “The demand for high-quality, point-of-care molecular diagnostic systems is higher than ever today. With this new plant, the production of Truenat kits has increased five times, from 70,000 tests per day to 3.5 lakh tests per day. The technology of Truenat will have serious implications for point of care testing in India, and the world.” “The new facility of Molbio was conceptualised when there was a big demand for COVID tests. We developed this plant in 9 months, incorporating some of the most cutting-edge technologies in automation and manufacturing here. We hope to grow this further in the coming days” said Sangeeta Sriram, Director and Plant Incharge, Molbio Diagnostics. ]]> https://biospectrumindia.com/news/97/19069/lifecell-launches-diagnostic-services.html https://biospectrumindia.com/news/97/19069/lifecell-launches-diagnostic-services.html Thu, 01 Jul 2021 15:50:00 +0530 LifeCell has ventured into a new diagnostic testing service with the launch of immuno transplant comprehensive testing. The new service comprises an array of diagnostic tests that cater to pre-and post-transplantation needs.    The comprehensive array of tests include biopsy packages, NGS-based HLA typing, infectious disease testing, and other advanced biochemical tests. The packages have been customised to suit the prerequisites for pre-and post-transplantation processes.                                                                                                     LifeCell has widened the state-of-the-art technology and testing expertise to the solid organ, bone marrow and cord blood transplant segment by offering key tests including the novel next-generation sequencing (NGS)-based HLA typing, flow cytometer, and Luminex-based allied tests. Notably, the success rate of a transplant is much dependent on the close match between the human leukocyte antigens (HLA) markers of the donor and the recipient in case of an organ, bone marrow, or cord blood transplant.   Ishaan Khanna, CEO, LifeCell International, said, “We have been offering the safe transplantation programme to our community cord blood banking members and this has equipped us with the relevant expertise to venture into the Immuno transplantation testing segment." ]]> https://biospectrumindia.com/news/97/19049/sgei-hssc-join-hands-to-upskill-gi-technicians-in-endoscopy-area.html https://biospectrumindia.com/news/97/19049/sgei-hssc-join-hands-to-upskill-gi-technicians-in-endoscopy-area.html Tue, 29 Jun 2021 16:00:00 +0530 Society of Gastrointestinal Endoscopy of India (SGEI) has signed a Memorandum of Agreement (MoA) with Healthcare Sector Skill Council (HSSC) to upskill the GI Technician in Endoscopy area. Gastrointestinal Endoscopy Technician Training (GETT) is India’s first on the job training course for GI technicians. As part of the MoA, SGEI will provide training and skill enhancement for participants through a certification program and build a pool of skilled endoscopy technicians for the country. The upskilling program is backed by leading industry players- Boston Scientific India Private Limited and Olympus Medical Systems. Endoscopy technicians, also known as Gastroenterology (GI) technicians or GI endoscopy technicians, primarily assist physicians with various endoscopic procedures. This upskilling initiative is an on-the-job skill enhancement programme. GETT is a well-established training program and was already certified by SGEI, and World Endoscopy Organization (WEO). The course is organized as an interrupted contact program, involving 4 modules.  The 4 modules will involve an aggregate of 72-hours of training. During the course, participants will receive didactic lectures, self-read material, opportunity to assist in procedures at the centres where they are primarily attached, and learn from doctors, and senior endoscopy technician peers. Additionally, participants will be exposed to different industry led innovations and learn from industry leaders in the field. Participants will also have opportunities to get accustomed to cutting-edge technology and equipment available in the industry. The first edition of GETT was conducted in six major cities such as Delhi, Hyderabad, Bangalore, Kochi, Chennai and Kolkata. The upcoming edition will further expand the reach to six more cities in the country. The new additions are Mumbai, Pune, Ahmedabad, Jaipur, Lucknow, and Vishakhapatnam. ]]> https://biospectrumindia.com/news/97/19030/india-achieves-milestone-of-40-cr-covid-19-sample-testing-till-june-25.html https://biospectrumindia.com/news/97/19030/india-achieves-milestone-of-40-cr-covid-19-sample-testing-till-june-25.html Mon, 28 Jun 2021 11:50:00 +0530 Indian Council of Medical Research [ICMR] has achieved the milestone of conducting 40 crores testing on June 25, 2021. With average testing of more than 18 lakhs per day in the month of June, India has tested 40,18,11,892 samples across the country till the above-mentioned date.   As on June 1, 2021, India had tested 35 crores COVID-19 samples. It reached 40 crores mark on June 25, 2021. This has been enabled by rapidly increasing testing infrastructure and capacity across the country. ICMR has been enhancing COVID-19 testing capability across the country by expanding and diversifying testing capacity by leveraging technology and facilitating innovation in affordable diagnostic kits.    Prof (Dr) Balram Bhargava, Director General, ICMR said, “We have effectively responded to the evolving epidemic through focussed and collaborative efforts of the Centre, State/UTs government. The exponential increase in testing has led to early identification, prompt isolation and effective treatment of COVID-19 cases. These have eventually resulted in a sustained low fatality rate. This testing milestone is testimony to the fact that India has been successful in implementing the strategy of 5T approach “Test, Track, Trace, Treat and use of Technology” efficiently, which will enable us to contain the spread of the pandemic.’’    The total number of diagnostic laboratories has reached 2675. Of which dedicated government laboratories are 1676 and private laboratories number stands at 999. ICMR has also approved India’s first self-use Rapid Antigen Test (RAT) for COVID-19 and is encouraging self-test kits to reduce queues in laboratories, reduce costs, dissipate the burden on existing manpower for a sample collection from homes, and provide results without delay.        ]]> https://biospectrumindia.com/news/97/19023/rapid-antigen-test-for-covid-19-by-iit-d-enters-market-at-rs-50.html https://biospectrumindia.com/news/97/19023/rapid-antigen-test-for-covid-19-by-iit-d-enters-market-at-rs-50.html Fri, 25 Jun 2021 18:15:00 +0530 The Rapid Antigen Test kit has been developed by the Indian Institute of Technology (IIT) Delhi researchers led by Dr Harpal Singh, professor at the Institute’s Centre for Biomedical Engineering. Minister of State for Education Sanjay Dhotre has launched a Rapid Antigen Test kit for COVID-19 developed by IIT Delhi.    Dhotre said, “I am confident that this technology will revolutionize the Covid test availability in the country. I am glad to know that the kit has been developed entirely using the internal resources at IIT Delhi.”    Speaking on this occasion, Prof V Ramgopal Rao, Director, IIT Delhi said, “IIT Delhi had in July 2020 launched a Rs 399 RT PCR kit, which helped bring the RT-PCR test costs to the current level. Using the technologies developed in the Institute, over 8 Million PPE kits have been supplied so far. With the launch of this antigen-based rapid test kit, we hope to make the diagnostics easy and affordable for the rural areas.” "The invention is directed towards an in vitro diagnostic kit for qualitative detection of SARS-CoV-2 coronavirus antigens in nasopharyngeal swab, using the rapid immune chromatographic method. The identification is based on the monoclonal antibodies specific for the Coronavirus antigen. A SARS-CoV-2 positive specimen produces a distinct color band in the test region, formed by the specific antibody antigen colored conjugate complex. Absence of this colored band in the test region suggests a negative result", he added. IIT Delhi has filed patent application for the developed technology and awarded license to two companies in the country for its commercial rollout. New Delhi-based Dia Sure Immunodiagnostic, is now entering the market with this kit, fixing the cost at Rs. 50/ per test.   ]]> https://biospectrumindia.com/news/97/19012/veeda-clinical-research-receives-growth-capital-worth-16m-from-sabre-partners.html https://biospectrumindia.com/news/97/19012/veeda-clinical-research-receives-growth-capital-worth-16m-from-sabre-partners.html Thu, 24 Jun 2021 13:00:00 +0530 Veeda Clinical Research, a full-service clinical research organisation (CRO) based in Ahmedabad, raised $16 million in a round led by private equity fund, Sabre Partners. This round also saw participation from distinguished HNIs such as Pranab Mody (of JB Chemicals), Havells India family office, Nikhil Vora (Founder of Sixth Sense Ventures ; amongst the first investors in companies such as Paytm, Fogg deodorant, etc.), Arjun Bhartia (of Jubilant), amongst others. Rajiv Maliwal, Founder and Managing Partner, Sabre Partners, said: “We are excited to partner with Veeda as an equity investor. The CRO industry is witnessing rapid growth resulting from a confluence of economic and regulatory tailwinds. We believe Veeda is well positioned to capitalise this opportunity as one of the largest independent full service clinical research organizations, by revenue in India, as of March 31, 2021. They offered broad range of services with experienced scientific talent and management team, and we look forward to working with them.” Ajay Tandon, Managing Director, Veeda said, “We are delighted that Sabre Partners and the other distinguished investors have chosen to partner with us in realising our vision of being the preferred research partner offering broad range of drug development, pre-clinical and clinical research services to our global innovator, generic and biopharma clients. We will continue to invest in developing our delivery capabilities, to be increasingly relevant to our clients objectives.” Veeda has an experience in conducting complex clinical studies.  In November 2018, a consortium of private equity investors led by CX Partners Fund 2 acquired a majority stake in Veeda. ]]> https://biospectrumindia.com/news/97/19001/wipro-ge-healthcare-starts-manufacturing-of-versana-ultrasound-range-in-india.html https://biospectrumindia.com/news/97/19001/wipro-ge-healthcare-starts-manufacturing-of-versana-ultrasound-range-in-india.html Wed, 23 Jun 2021 11:55:00 +0530 Wipro GE Healthcare has enhanced its local capability to manufacture a wide range of Versana products in India. This is part of the company’s strategy to expand localisation and strengthen the supplier ecosystem. The Versana Ultrasound range is part of the company’s affordable product portfolio and will be manufactured at its state-of-the-art facility in Kadugodi, Bengaluru. Shravan Subramanyam, MD, Wipro GE Healthcare, South Asia said, “With this new local manufacturing we will cut down our imports of the Versana range by half. With local manufacturing, we can fast-track the availability of these critical care equipment. The price benefit will also be passed on to our customers.”“By end of 2021, the plan is to locally manufacture seven ultrasound products catering to OB/GYN, radiology, cardiology, anaesthesia, emergency, and critical care segments,” he added. Currently, a Versana ultrasound device can be built in India with a 1.5-hour turnaround time owing to the agile supply chain ecosystem, thus enhancing responsiveness to customers requirements. “For healthcare professionals, ultrasound plays a critical role in drawing patient data and visualisation, helping them make more informed decisions that may lead to better clinical outcomes for patients. Our ultrasound machines under the brand names Versana, LOGIQ and Vivid with their innovative technologies has seen growing demand in India especially in the value segment. These product lines will now be manufactured in the country,” adds Ashit Shah, Business Head, Ultrasound, Wipro GE Healthcare, South Asia. ]]> https://biospectrumindia.com/news/97/18988/j-mitra-launches-covid-19-ag-microlisa-elisa-test-kit.html https://biospectrumindia.com/news/97/18988/j-mitra-launches-covid-19-ag-microlisa-elisa-test-kit.html Tue, 22 Jun 2021 11:40:00 +0530 J Mitra and Company has launched the COVID-19 Ag Microlisa Elisa Test kit (Elisa Antigen Test (EAT)) for the Indian market. The test kit will provide better time efficiencies by reducing the turnaround time between testing and results to just two hours.   The principle of the test kit is Sandwich Elisa and any open Elisa kit Reader available in the market can read the results. Open-system will result in efficient testing even in the remotest corners of the country.    The COVID-19 Ag Microlisa Elisa Test kit has been designed for the in-vitro qualitative detection of COVID-19 nucleocapsid antigen in nasal and oropharyngeal swabs and sample diluent.   The Elisa Antigen COVID-19 test offers high sensitivity and specificity, and accuracy equivalent to RT-PCR tests. The combination of low cost, speed, and accuracy makes the Elisa Antigen Covid-19 Test kit a powerful solution for the diagnostic labs to fast-pace India's comprehensive monitoring and detection process. All necessary approvals from ICMR and DCGI have been received.   Lalit Mahajan, Chairman, J Mitra & Co said, “The Elisa Antigen Test is our 10th R&D based product in the fight against COVID-19. We are committed to the masses and will strive to help in the eradication of the disease.”   Mahajan added, “The Elisa Antigen test will help in management and mitigation of risks through quicker and reliable results - positive patients can be quickly isolated. For the masses, this test will minimise uncertainty and confusion due to prolonged delays in test results – to decide whether it is safe to interact or isolate and quarantine. We hope to majorly transform the testing and detection scenario with this path-breaking product.” ]]> https://biospectrumindia.com/news/97/18961/csir-tata-md-partner-to-make-covid-19-detection-more-accessible.html https://biospectrumindia.com/news/97/18961/csir-tata-md-partner-to-make-covid-19-detection-more-accessible.html Fri, 18 Jun 2021 16:00:00 +0530 The Centre for Scientific and Industrial Research (CSIR) and Tata MD, the new healthcare venture from the Tata Group, have announced a significant partnership to ramp up the COVID-19 testing capacity across Tier II and III towns as well as rural areas across India. CSIR and Tata MD are developing this capacity to manage any future surge in the COVID-19 testing requirements.The initiative will utilise CSIR’s network of labs across India and help increase India’s testing capacity in smaller locations in the country. CSIR and Tata MD will jointly develop the testing capacity and the RT-PCR CRISPR test will be done using the Tata MD CHECK SARS-CoV-2 test kits that are powered by FELUDA technology from CSIR-IGIB.“Apart from vaccination, rapid testing and isolation of SARS-CoV-2 positive persons has emerged as the best strategy in combating Covid-19. This initiative in partnership with Tata MD, to deploy the RT-PCR CRISPR test across multiple CSIR labs spread across the country is an important step. This will augment the national capacity to test for COVID and detect it locally,” said Dr Shekhar C Mande, Director General, CSIR.Tata MD is also deploying a proprietary three-room design mobile testing lab that can conduct end-to-end, on-site COVID-19 testing to increase the testing capacity in the state.The partnership between CSIR and TATA-MD is aimed at expanding the testing capacity further over the next few months by deploying the TATA-MD CHECK testing via the vast network of 37 CSIR labs spread across the country from CSIR-IIIM in Jammu in North to CSIR-NIIST in Thiruvananthapuram in South and CSIR-CSMCRI, Bhavnagar in West to CSIR-NEIST Jorhat in North-East.The first CSIR lab to go live with Tata MD is located at CSIR-Indian Institute of Petroleum (IIP), Dehradun, Uttarakhand.  ]]> https://biospectrumindia.com/news/97/18936/india-medtronic-launches-worlds-smallest-pacemaker-to-treat-heart-block.html https://biospectrumindia.com/news/97/18936/india-medtronic-launches-worlds-smallest-pacemaker-to-treat-heart-block.html Wed, 16 Jun 2021 12:25:00 +0530 India Medtronic, a wholly-owned subsidiary of Medtronic, announced the launch of Micra AV - a miniaturised, fully self-contained pacemaker that delivers advanced pacing technology to atrioventricular (AV) block patients via a minimally invasive approach. The device is the first pacemaker that can sense atrial activity without a lead or device in the upper chamber of the heart.   Identical in size and shape to the original Micra Transcatheter Pacing System (TPS), Micra AV is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Micra AV has several additional internal atrial sensing algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing “AV synchronous” pacing therapy to patients with AV block.   “With Micra AV, patients suffering from complete heart block have the option for a leadless device that is delivered through a minimally invasive procedure and is cosmetically invisible to the patient,” said Abhishek Bhargava, Director, Cardiac Rhythm Management, Cardiac Ablation & Diagnostics at Medtronic India.    Micra AV received United States Food and Drug Administration approval based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra’s internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony. The study’s primary safety objective was also met, with no pauses or episodes of pacing-induced tachycardia reported during algorithm mediated AV synchronous pacing.   ]]> https://biospectrumindia.com/news/97/18932/thermo-fisher-expands-sars-cov-2-testing-portfolio-in-india-with-accula-system.html https://biospectrumindia.com/news/97/18932/thermo-fisher-expands-sars-cov-2-testing-portfolio-in-india-with-accula-system.html Tue, 15 Jun 2021 21:00:00 +0530   Thermo Fisher Scientific has announced a introduction of the new and innovative SARS-CoV-2 Test that delivers gold-standard reverse transcription polymerase chain reaction (RT-PCR) detection of SARS-CoV-2 in a point-of-care format.  The Accula SARS-CoV-2 Test has received Emergency Use Authorization (EUA) from the United States (U.S.) Food and Drug Administration (FDA) for the detection of SARS-CoV-2 in Clinical Laboratory Improvement Amendments (CLIA)–waived environments.   “Since the start of the pandemic, Thermo Fisher has acted quickly to provide support to the scientists and healthcare professionals at the frontlines of combating COVID-19,” said Amit Chopra, managing director, India and South Asia, Thermo Fisher Scientific. “This new testing platform combines the accuracy of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays. The Accula SARS-CoV-2 Test is a natural extension of our existing offerings and will help meet the continuing demands for rapid and reliable COVID-19 testing in India.”    RT-PCR testing is streamlined from start to finish using a fully integrated, single-use microfluidic test cassette and the reusable, palm-sized Accula Dock. The test uses nasal swab samples and provides reliable, qualitative results in approximately 30 minutes. The Accula SARS-CoV-2 Test is enabled by proprietary PCR technology that allows for reduced absolute temperatures and reduced temperature differentials—resulting in rapid exponential amplification while reducing overall thermocycling times.    “The rapid Accula point-of-care test will open new avenues of personal and public testing without compromising on accuracy,” added Amit. “The introduction of the test in India is a demonstration of the impact our solutions have on human health during the pandemic, and far beyond." In January 2021, Thermo Fisher acquired Mesa Biotech Inc., which developed the Accula SARS-CoV-2 Test to provide accurate and faster results at the point of care.   ]]> https://biospectrumindia.com/news/97/18922/abbott-india-launches-device-to-treat-congenital-heart-defects-in-premature-babies.html https://biospectrumindia.com/news/97/18922/abbott-india-launches-device-to-treat-congenital-heart-defects-in-premature-babies.html Tue, 15 Jun 2021 12:00:00 +0530 Abbott, the global healthcare company, has launched its Amplatzer Piccolo™ Occluder in India, the world's first medical device that can be implanted in the tiniest babies (weighing as little as 700 gms) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. One of the most common congenital heart defects occurring in premature babies, PDA is a potentially life-threatening opening between two blood vessels leading from the heart. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medicine and are at high risk to undergo corrective surgery. "Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts," said Payal Agrawal, general manager for Abbott's structural heart business in India and the Subcontinent. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. It is designed to allow the physician to insert it through the aortic or pulmonary artery, as well as to retrieve and redeploy the device for optimal placement. Because the device is deployed in a minimally invasive procedure, many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the procedure. "This product is a potentially life-saving advance that will help us treat these delicate infants who might otherwise not be able to survive," said Dr. Edwin Francis, Senior Consultant, Head of Paediatric Cardiology Department, Lisie Hospital, Ernakulum. He further added, “This is an excellent pre-loaded device, which means it doesn’t need much preparation, and has a softer profile that is easy to deploy. It has more variety in terms of size and is therefore suitable for babies of different ages and weight.” ]]> https://biospectrumindia.com/news/97/18916/smt-announces-everoct-study-results-in-catheterization-and-cardiovascular-intervention.html https://biospectrumindia.com/news/97/18916/smt-announces-everoct-study-results-in-catheterization-and-cardiovascular-intervention.html Mon, 14 Jun 2021 17:45:00 +0530 Sahajanand Medical Technologies (SMT) announced the publication of EverOCT study in Catheterization and Cardiovascular Intervention (CCI) journal evaluating three and six months results of its EVERolimus-eluting Coronary Stent, Tetrilimus by OCT analysis.  The study assesses the immediate results and healing pattern in two different time frames. EverOCT was a prospective, multi-centre, single-arm, and investigator-initiated study performed at seven Indian sites between January 2017 and September 2018. OCT evaluations were done on 57 patients who underwent Tetrilimus stent implantation. Follow-up OCT was scheduled at three months for the first 16 patients and at six months for 41 patients. Primary outcomes included degree of strut coverage, malapposition and thickness of neointimal hyperplasia (NIH) over covered struts.Presently there is no available data about the healing pattern of everolimus coated ultra-thin struts (60 μm). This is the only study that documents the OCT healing parameters of ultra-thin strut stents larger than 3.00 mm. Tetrilimus has the ultra-thin strut thickness (60 μm) for the entire size matrix (2.0 to 4.5 mm diameter).EverOCT study was aimed to evaluate healing response at strut-level and cross-section level of the new everolimus-eluting ultra-thin stent (60 μm) with a biodegradable polymer, using serial OCT analysis at three and six months after implantation.61 Tetrilimus stents were implanted to treat 59 lesions in 57 patients. Paired (baseline and follow-up) OCT data were available for 12 patients and 30 patients at three and six months, respectively. At three months, rapid early healing was indicated by 95.48 per cent covered struts per lesion with very low (0.11 ± 0.06 mm) NIH. At six months, NIH accumulation was greater (0.21 ± 0.07 mm) as compared to three months. 99.77 per cent of struts per lesion were covered at 6 months.Data regarding >3.00 mm diameter stents were unique as the comparative data showed that there was no significant difference in coverage of stents, eccentricity index and NIH thickness over the struts as compared to ≤3.00 mm diameter stents. Tetrilimus portrays uniform expansion and concentric apposition over the vessel wall. ]]> https://biospectrumindia.com/news/97/18884/meril-bags-icmr-approval-for-self-use-covid-19-test-covifind.html https://biospectrumindia.com/news/97/18884/meril-bags-icmr-approval-for-self-use-covid-19-test-covifind.html Thu, 10 Jun 2021 00:00:00 +0530 Gujarat-based global medtech company Meril has received the Indian Council of Medical Research (ICMR) approval for its self-use Rapid Antigen Test for COVID-19, CoviFind. The CoviFind test delivers results swiftly, providing accurate results in just 15 minutes. Additionally, the test does not have any specific storage or refrigeration requirements, thus driving ease and convenience in distribution.   The test is priced at Rs 250 and will be made available as an affordable single-pack, with additional purchase options including a pack of 3, 5 and 25 tests. Each test kit is equipped with testing materials including a test device, one sterile nasal swab and a pre-filled buffer tube with a cap.    The nasal swab offers a less invasive testing option and enables quick and convenient specimen collection while reducing discomfort, improving testing compliance. Nasal swabs only have to be inserted 2 to 4 centimetres (cms) into a patient’s nose, as compared to the alternative nasopharyngeal swab that needs to be inserted 8 to 10 cms into the nasopharynx for adults.     The self-use test is to be used alongside the company’s official home testing mobile application, ‘CoviFind App,’ which will be available to download from the Google Play Store and Apple App Store once the product hits the market.    Meril will also run a dedicated website for direct orders of the test kit by individuals and institutions. A special 25-test kit option is available for institutions, corporations, schools and other large orders.    Sanjeev Bhatt, Sr Vice President, Corporate Strategy, Meril, said, “Meril’s CoviFind test will facilitate early detection, isolation, treatment and contact tracing. This will limit the spread of infections, contributing to the nation’s ongoing efforts to quell the second wave of the pandemic."  ]]> https://biospectrumindia.com/news/97/18870/roche-launches-lab-based-elecsys-sars-cov-2-antigen-test.html https://biospectrumindia.com/news/97/18870/roche-launches-lab-based-elecsys-sars-cov-2-antigen-test.html Tue, 08 Jun 2021 18:10:00 +0530 Roche has launched a SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections.   The laboratory-based Elecsys SARS-CoV-2 Antigen test had earlier received CE mark has recently obtained the import license from CDSCO. The automated lab-based antigen test could be useful in diagnosing symptomatic patients and exposed asymptomatic individuals. In addition, it will facilitate frequent screening of individuals in high-risk settings.   Roche’s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx.   The Elecsys SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This test can help provide faster reporting and could also be used in setups wherein the PCR testing is either limited or not available, thus reducing turnaround time for samples.   In symptomatic individuals, a positive result with the Elecsys SARS-CoV-2 Antigen test indicates an active SARS-CoV-2 infection with a likelihood of 94.5 per cent. A negative result may require to be confirmed with a PCR test or repeated (antigen test) after one to two days if other clinical indications point to a SARS-CoV-2 infection.    The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available in India and allow for these test to be run alongside other COVID-19 and other infectious diseases markers available from Roche, which run on the cobas e systems. This test, running on the electrochemiluminescence technology, ensures high accuracy and precision in testing. These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser.   ]]> https://biospectrumindia.com/news/97/18862/fujifilm-india-max-healthcare-conclude-radio-diagnostics-fellowship-training-in-breast-cancer.html https://biospectrumindia.com/news/97/18862/fujifilm-india-max-healthcare-conclude-radio-diagnostics-fellowship-training-in-breast-cancer.html Tue, 08 Jun 2021 14:10:00 +0530 Fujifilm India along with Max Super Speciality Hospital, Saket announced their second fellowship (completion) as part of an ongoing programme to train doctors in breast imaging and advance diagnostics. The brands organised a felicitation ceremony to celebrate the success of their association and congratulated Dr Aishwarya B Sridhar for completing her certification course in radio diagnostics and proficiently completing her training. Guided and trained by a team of professionals including Dr Bharat Aggarwal, Director - Radiology Services, Max Super Speciality Hospital, Saket and Dr Harit Chaturvedi, Chairman - Max Institute of Cancer Care, Dr Aishwarya B Sridhar is the second radiologist to complete the fellowship programme. Last year, Dr Pragya Garg, MD was the first to complete and receive recognition under this fellowship.   Fujifilm and Max Healthcare hospital as part of their association are running this fellowship programme to train doctors in breast mammography, breast MR, and breast ultrasound techniques for a six-month duration. Through this, they aim to train two radiologists each year towards the early detection of breast cancer.Chander Shekhar Sibal, Senior Vice President & Head of Medical Division, Fujifilm India said, “We are delighted to announce the second fellowship certificate in radio-diagnostics to another doctor this year. Our association with Max Healthcare has given us a platform to train doctors about screening facilities that can help in early detection and save the lives of many. With this achievement, we pledge to continue to raise awareness about the benefits of mammography screening for early detection of breast cancer among women.” ]]> https://biospectrumindia.com/news/97/18832/mylab-initiates-shipment-of-covid-19-self-test-kit-coviself.html https://biospectrumindia.com/news/97/18832/mylab-initiates-shipment-of-covid-19-self-test-kit-coviself.html Thu, 03 Jun 2021 17:20:00 +0530 Pune-based Mylab Discovery Solutions recently announced the commercial launch of its COVID-19 self-test kit, CoviSelf. It has received approval from the Indian Council for Medical Research (ICMR) and can be self-administered by citizens at home. This indigenous test kit will be distributed to 95% of the PIN codes in the county and will be available over-the-counter at pharmacies and drugstores across India. Individuals can also order it online through India’s homegrown e-commerce marketplace, Flipkart. To ensure safe deliveries, Flipkart also offers contactless payments for consumers and will leverage its safe and sanitized supply chain. The company will roll out 1 million self-test kits starting today and based on consumer demand, it will make 7 million units available per week. The product should be available in retail within 2-3 days. The company plans to make the products available on the Government e-marketplace (GEM).   Priced at Rs 250, CoviSelf can be used by individuals with or without symptoms and immediate contacts of confirmed cases as per the ICMR guidelines. Designed as the mid-nasal swab test, it can detect positive results in just 15 mins. Each unit contains a testing kit, instructions to use (IFU) leaflet and a bag to safely dispose of after testing.   ]]> https://biospectrumindia.com/news/97/18818/redcliffe-lifetech-introduces-mucormycosis-multiplex-rt-pcr-test.html https://biospectrumindia.com/news/97/18818/redcliffe-lifetech-introduces-mucormycosis-multiplex-rt-pcr-test.html Wed, 02 Jun 2021 14:35:00 +0530 Noidda-based Redcliffe Lifetech has introduced a non-invasive (Serum/Fluid) RT-PCR Test to detect the DNA of mucorales species. As a part of the diagnostic process, BAL samples will be used to directly detect the infection, with sample-to-result collection in less than 24 hours. Redcliffe Lifetech through its innovative molecular diagnostic service will collect various samples for conducting RT-PCR Test such as Bronchoalveolar lavage (BAL) samples, Biopsy samples, paraffin-embedded, serum samples to detect the potential health disorder or diseases in people. The diagnosis of Mucormycosis will target Pan-Mucormycetes, Rhizopus spp., Mucor spp., Lichtheimis spp., Cunninghamella spp., Rhizomucor spp., Internal Control (IC). Dheeraj Jain, Managing Director, Redcliffe Lifetech said, “We endeavour to assist the Government of India and the general public in combating this deadly infection with the most advanced approach. With the help of our technology, we can assist them in a timely diagnosis of Mucormycosis. This will undoubtedly aid in the diagnosis and treatment of patients.” The company is pricing the test at Rs 7,000. ]]> https://biospectrumindia.com/news/97/18807/roche-diabetes-care-appoints-omar-sherief-mohammadashead-india-middle-east-africa.html https://biospectrumindia.com/news/97/18807/roche-diabetes-care-appoints-omar-sherief-mohammadashead-india-middle-east-africa.html Tue, 01 Jun 2021 14:15:00 +0530 Roche has appointed Omar Sherief Mohammad as Head India, Middle East & Africa (IMEA) within the Roche Diabetes Care (RDC) Global Commercial Organisation, based in Mumbai. Before this appointment, Omar has been General Manager RDC India since September 2019. Mohammad will play a key role in the shaping and executing of the overall commercial Go-To-Market Strategy, responsible for setting the strategic direction for IMEA, in alignment with the Global Commercial Organisation as well as the overall RDC strategy. In this newly created role, he will have direct oversight of IMEA and the RDC General Managers/Country Heads of these markets will directly report to him. Omar will also be General Manager in India. Mohammad said, “I strongly feel that there is a need for improving access to care to support the underprivileged section of the community by creating a holistic ecosystem for screening, awareness and education programs. I look forward to leading my teams across the IMEA region towards dedicating efforts to bend the curve of diabetes in terms of prevalence and adding value by bringing true relief for people with diabetes.” As head of IMEA, Mohammad will steer the countries under his charge to amplify this patient-centric approach and collaborate with various stakeholders to address the burden of diabetes in the region. Mohammad has two decades of experience in the pharmaceutical sector, primarily in diabetes care, in India, global marketing in Denmark and emerging Asian markets. Before joining Roche, Omar was the VP and GM of Novo Nordisk, Vietnam and other Southeast Asia emerging markets. ]]> https://biospectrumindia.com/news/97/18805/trivitron-healthcare-launches-hplc-based-diagnostic-solutions.html https://biospectrumindia.com/news/97/18805/trivitron-healthcare-launches-hplc-based-diagnostic-solutions.html Tue, 01 Jun 2021 12:20:00 +0530 Trivitron Healthcare has launched two new innovation-driven products for HbA1c and Hb variant detection. The new product includes NANO H5 & NANO H110 which are high-performance liquid chromatography analysers for HbA1c detection in less than three minutes. These HPLC-based HbA1c analysers will be used for monitoring diabetes, thalassemia and haemoglobin variants. NANO H5, is a compact, automated HPLC analyser that uses ion exchange liquid chromatography for the quantitative determination of the glycated haemoglobin (HbA1c) in human whole blood with a processing time of 130 seconds that will expedite the laboratory TAT. The fully automated analyser which promises to process five samples at a time will take Trivitron Healthcare to reach the pinnacle of precision within a designated time frame in the global diagnostic market. NANO H110 is a compact, automated HPLC analyser that has a dual test mode for HbA1c test and Hb Variant detection. It has some advanced facilities such as a barcode scanner and cap piercing with a high sample loading capacity of 110 samples at a time which make it suitable for laboratories with medium to large workloads. Rajesh Patel, CEO (IVD Business), Trivitron Healthcare on this occasion said, “Keeping in mind the increasing concern for the management of diabetes and the growing demand for accurate measurement of HbA1c level, today we are delighted to announce the launch of HPLC-based HbA1c analyzers - NANO H5 & NANO H110, that are compact and designed for precision.” ]]> https://biospectrumindia.com/news/97/18748/healthium-medtech-steps-up-production-of-essential-medical-devices.html https://biospectrumindia.com/news/97/18748/healthium-medtech-steps-up-production-of-essential-medical-devices.html Wed, 26 May 2021 17:00:00 +0530 Healthium Medtech, based in Bengaluru, has announced that it has strengthened its operations to fast track delivery of essential medical devices as the country fights the ongoing battle against COVID-19. Healthium has scaled its production, extended its supply chain and fast-tracked the deliveries of essential medical devices and consumables to support healthcare frontline workers. To ensure adequate supply of medical devices for healthcare practitioners, the company is running its plants during lockdown with due permissions and pre-cautionary measures. The company has also expanded supply chain by 40 per cent to fast track critical deliveries. Considering the surge in demand for gloves at hospitals across the country, the company has utilised multiple production lines, and also stepped up production of first of its kind anti-microbial gloves TRUSHIELD, that protects both surgeons and patients against microbes. A significant production of gloves have been earmarked for government hospitals. The company has also provisioned for up to two months of stock of critical products codes for emergency surgeries like cardio-vascular surgeries and OB-GYN led surgeries, which continue despite the pandemic.   ]]> https://biospectrumindia.com/news/97/18708/drdos-dipas-develops-covid-19-antibody-detection-kit.html https://biospectrumindia.com/news/97/18708/drdos-dipas-develops-covid-19-antibody-detection-kit.html Fri, 21 May 2021 17:55:00 +0530 Defence Institute of Physiology and Allied Sciences (DIPAS), a laboratory of Defence Research and Development Organisation (DRDO), has developed an antibody detection-based kit 'DIPCOVAN', the DIPAS-VDx COVID-19 IgG Antibody Microwell ELISA for sero-surveillance. The DIPCOVAN kit can detect both spikes as well as nucleocapsid (S&N) proteins of the SARS-CoV-2 virus with a high sensitivity of 97 per cent and specificity of 99 per cent. The kit has been developed in association with Vanguard Diagnostics Pvt Ltd, a development and manufacturing diagnostics company based in New Delhi. The DIPCOVAN kit was developed indigenously by the scientists, followed by extensive validation on more than 1,000 patient samples at various COVID designated hospitals in Delhi. Three batches of the product were validated during the last year. The antibody detection kit is approved by the Indian Council of Medical Research (ICMR) in April 2021. The product received regulatory approval from the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, to manufacture for sale and distribution. DIPCOVAN is intended for the qualitative detection of IgG antibodies in human serum or plasma, targeting SARS-CoV-2 related antigens. It offers a significantly faster turn-around time as it requires just 75 minutes to conduct the test without any cross-reactivity with other diseases. The kit has a shelf life of 18 months. Industry partner Vanguard Diagnostics will commercially launch the product during the first week of June 2021. Readily available stock at the time of launch will be 100 kits (approx. 10,000 tests) with a production capacity of 500 kits/month after the launch. It is expected to be available at about Rs 75 per test.   ]]> https://biospectrumindia.com/news/97/18701/indica-labs-ibex-to-deliver-ai-powered-clinical-workflows-for-digital-pathology.html https://biospectrumindia.com/news/97/18701/indica-labs-ibex-to-deliver-ai-powered-clinical-workflows-for-digital-pathology.html Fri, 21 May 2021 12:15:00 +0530 Indica Labs, an industry leader in quantitative digital pathology and image management solutions, and Ibex Medical Analytics, a pioneer in artificial intelligence (AI)-based cancer diagnostics, announced an agreement to integrate the Galen AI-based cancer diagnostics platform into the HALO AP digital pathology workflow platform. The HALO AP platform was developed by Indica Labs to address the needs of digital anatomic pathology labs. The platform can be fully integrated within existing LIS or HIS solutions or can operate as a standalone case and image management system for anatomic pathology. Furthermore, HALO AP supports a full range of tissue-based assays and workflows, including synoptic reporting, tumour boards, secondary consults, quantitative analysis, and AI-assisted workflows. HALO AP is used by some of the largest anatomic pathology laboratories in the world, including NeoGenomics and the National Cancer Institute (NCI). Ibex’s Galen platform uses strong AI algorithms that support pathologists in improving the quality of cancer diagnosis and providing productivity-enhancing insights that help reduce turnaround times. ]]> https://biospectrumindia.com/news/97/18687/neoscan-solutions-launches-mri-scanner-for-babies.html https://biospectrumindia.com/news/97/18687/neoscan-solutions-launches-mri-scanner-for-babies.html Thu, 20 May 2021 17:30:00 +0530 Neoscan Solutions has invented an MRI scanner for babies. The smaller and lighter MRI scanner can be placed directly in the children's ward of the hospital. Key to the much smaller design is the use of digitizers and AWGs by Spectrum Instrumentation that offer sub-nanosecond, coherence precision to generate the scanner signals and capture the results. Neoscan will be shortly installing its first devices in German hospitals where it can be seen in operation by prospective customers as it takes images of babies. The certification process with a CE mark is expected to be completed before the end of 2021. Says Stefan Roell, Founder, Neoscan Solutions in Germany, "We have designed an MRI scanner specifically for newborns and infants which means that the hole in the middle is only 30cm in diameter, not 60cm. As a result, the scanner is much smaller (170cm x 150cm x 110cm) and can go through standard doorways. With a weight of only 2000 kg, it can be located on standard floors and, needing only ten square metres, it can be installed in a spare room directly on the children's ward. Carrying a sleeping baby only a few meters to the MRI is a big advantage, saving a long journey through the building and the need for sedatives to keep the baby motionless for the scan." "As a start-up, we could not afford to create specialised hardware and so we used this route of high quality, standard cards providing a platform to run our software on," added Dr Roell. Firstly, to shrink the size, the team had to develop a dry magnet that would create the standard 1.5 Tesla field inside the hole, but without requiring liquid helium. This is done by an inner, cylindrical magnet generating 2.5T and then an outer cylindrical magnet that counteracts theinner field to provide strong, active magnet shielding so that there is no stray magnetic field left beyond about 1m from the device's cover.The second innovation was in control electronics. Current MRI scanners typically require three big racks of specially developed electronics, that have been custom designed and built by the MRI manufacturer. Neoscan Solutions chose a different approach. The team used a PC that runs the software that Neoscan has created plus high-end measurement PC cards from Spectrum Instrumentation. The signals for the MRI are generated by the M4i.6620-x8 and M2p.6546-x4 AWGs (Arbitrary Waveform Generators) and then analysed using an M2p.5968-x4 digitizer. The system used Spectrum's SCAPPsoftware drivers that enable a Graphics Processor with 5000 cores to perform the parallel processing, instead of using only 8 or 16 cores of a normal CPU. ]]> https://biospectrumindia.com/news/97/18683/mylab-unveils-indias-first-self-use-covid-19-test.html https://biospectrumindia.com/news/97/18683/mylab-unveils-indias-first-self-use-covid-19-test.html Thu, 20 May 2021 13:25:00 +0530 Pune based Mylab Discovery Solutions – the company that gave India its first RTPCR test a year ago, has announced that it has received ICMR’s approval for India’s first self-use Rapid test for COVID-19. The test is developed in India and is named as CoviSelf. The self-use test can be used by symptomatic individuals and immediate contacts of confirmed cases as per the guidelines of the Indian Council of Medical Research (ICMR). Users of this test will not need sample collection by a healthcare professional. This will ease pressure on already overburdened testing labs and reduce delays in testing, which is more than 72 hours in some parts of the country. Each kit will be provided with all testing materials, instructions to use (IFU) leaflet and a biohazard bag to safely dispose after testing. The test is designed to be done using nasal swab (not the deep nasopharyngeal swab) to reduce the discomfort. CoviSelf will provide results in 15 min and people who test positive should immediately isolate so that they do not infect others and quickly contact a healthcare provider. Those who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. Hasmukh Rawal, Managing Director of Mylab Discovery Solutions said that “This is the biggest crisis our country has ever faced. Time and again, we have tried to observe carefully what our country needs and developed solutions with social benefit at the core. With CoviSelf, we are sharing the power of testing early with the citizens. It will save thousands of lives. For India, we will make millions of kits available at fraction of the cost of such kits in the US.“. Mylab will price this test at Rs 250 and it will be available in an affordable pack of one. The company will start shipping out tests within a few days. Mylab current production capacity is 70 lakh tests per week and plans to increase its capacity to 1 Crore tests per week within 14 days. ]]> https://biospectrumindia.com/news/97/18669/fujifilm-teams-up-with-qure-ai-for-intelligent-x-ray-solutions.html https://biospectrumindia.com/news/97/18669/fujifilm-teams-up-with-qure-ai-for-intelligent-x-ray-solutions.html Wed, 19 May 2021 00:00:00 +0530 Fujifilm India has announced that FUJIFILM Corporation has introduced X-ray solutions augmented with qXR, Qure.ai’s computed aided radiology software application designed with deep-learning Artificial Intelligence (AI) technology. According to Mumbai based Qure.ai, the AI will analyze X-ray images to detect abnormal findings within seconds. Fujifilm’s portable X-ray FDR Xair system are equipped with a new image processing box called Expansion Unit EX-Mobile enabling to connect with qXR software. It will assist clinicians and technicians by flagging abnormal findings at the point-of-care. Qure’s peer-reviewed and proven chest X-ray interpretation technology, qXR can detect suspected abnormalities indicative of COVID-19, tuberculosis, lung cancer, misplaced catheters and multiple other radiological findings allowing for further review and confirmatory testing. The technology has been extensively trained on a global dataset and can be used for both adult as well as pediatric images. Another significant advancement is that the combination of EX-Mobile with Fujifilm’s portable X-ray FDR Xair system will bring the benefit of Qure’s AI technology not only to hospitals, but also regions which are geographically distant from the cities and emergency critical care. Furthermore, it will respond to the rapidly increasing global demand for support for effective lung procedures at medical sites, especially during the disease outbreaks. ]]> https://biospectrumindia.com/news/97/18644/anderson-diagnostics-supports-indigenous-development-of-tatamd-check-covid-19-test.html https://biospectrumindia.com/news/97/18644/anderson-diagnostics-supports-indigenous-development-of-tatamd-check-covid-19-test.html Sat, 15 May 2021 01:05:00 +0530 Anderson Diagnostics, located in Chennai, has collaborated with TataMD to help produce COVID test kits. The partnership is expected to scale test kit production and optimise COVID tests. This, in turn, will help bring down the infection rate. Anderson Diagnostics announced its partnership with Tata Medical and Diagnostics to support the indigenous development of TataMD Check, a COVID diagnostic kit that is completely developed in India. It is a novel COVID test kit developed based on ICMR guidelines and approved by DGCA. The kit is based on the Feluda CRISPR technology and has already conducted more than 10000 tests. Dr. Srinivasaraman, Director, Anderson Diagnostics and Labs, said, “Our collaboration with the Tata MD has helped us clinically support the pandemic by transforming COVID testing.”  Girish Krishnamurthy, MD & CEO, Tata Medical and Diagnostics, said, "We are happy to work with the smart and productive team at Anderson Diagnostics. The partnership has strengthened our capacity to produce a technology-based product like TataMD CHECK. The collaboration will drive innovation in the diagnostic space of the pandemic, which will scale the testing capacity in remote areas.” ]]> https://biospectrumindia.com/news/97/18623/univlabs-brings-indias-first-indigenous-4k-endoscope-tower.html https://biospectrumindia.com/news/97/18623/univlabs-brings-indias-first-indigenous-4k-endoscope-tower.html Wed, 12 May 2021 18:15:00 +0530 UnivLabs Technologies Pvt Ltd is India’s first company to indigenously design and manufacture a full-fledged 4K endoscope tower, whose performance is at par with the tower that India imports from global giants and it has been developed at a cost that is 1/3rd less than the cost of the imported machines. All the individual components of the tower like the body cavity illuminator, Co2 insufflator, hysteroscopy pump, laparoscopy pump have been conceived and manufactured by the company in India and the most advanced 4K camera has been developed under an MoU with a Japanese imaging company.  Gurugram based UnivLabs along with its technologically superior products has introduced the ‘Pay per use’ model wherein hospitals can own the endoscope tower with an initial investment of one-third of the total cost thus reducing early ownership cost. UnivLabs has also innovated the industry’s first & unique service delivery system ‘one button service request’ (OBSR) model for proactive service and maintenance. With an affordable product and unique service delivery model UnivLabs has an aggressive goal to install 5000 4K endoscope towers in the next three years to give a major boost to the adaptation of minimally invasive surgeries across India.  Sunil Singh, Founder and CEO, UnivLabs, says "Considering the scale of our country and population, we shall localise the design and manufacture of most of the medical devices. Our stress should not be only to build innovative devices but all devices for which India depends on imports, truly flagging up the ‘Make in India’ vision.”    ]]> https://biospectrumindia.com/news/97/18607/ss-innovations-receivesatma-nirbhar-bharat-award.html https://biospectrumindia.com/news/97/18607/ss-innovations-receivesatma-nirbhar-bharat-award.html Tue, 11 May 2021 12:15:00 +0530 SS Innovations, the creators of South Asia's First Surgical Robotic System has won the prestigious Atma-NirBhar Bharat Award on the occasion of ‘National Atmanirbhar Bharat E-Summit’ for exemplary work towards achieving atmanirbharta. This achievement is truly a mark of self reliance for the company and the nation. SS Innovations is involved in the design and development of an advanced cost-effective surgical robotic system known as MANTRA, which will benefit many more patients around the world. The MANTRA system was recently utilised for the first in a human pilot study at Rajiv Gandhi Cancer Institute, where the surgeons successfully completed 18 complex urology, gynaecology and general surgery procedures in less than a month. On receiving this award, Dr Sudhir Srivastava, Founder, and Chairman, SS Innovations said, “We are extremely honoured to have received this Atma-NirBhar Bharat Award. Our vision is to create a technologically advanced system that will be cost-effective, easy to use, and can be applied to all surgical specialties. I am very proud that we could do this type of project which is very unique for our country and will be recognised globally.   ]]> https://biospectrumindia.com/news/97/18604/lifecell-introduces-first-of-its-kind-diagnostic-test-for-better-newborn-health.html https://biospectrumindia.com/news/97/18604/lifecell-introduces-first-of-its-kind-diagnostic-test-for-better-newborn-health.html Tue, 11 May 2021 00:00:00 +0530 With an aim to provide the best possible healthcare to every child born in India, LifeCell, India’s leading diagnostic solutions provider, has introduced the first-of-its-kind diagnostic test called Omega Score. The OmegaScore-Prenatal and OmegaScore-Newborn test has been specially designed for Indian pregnant women as well as mothers respectively to determine the concentration of a critical omega-3 fatty acid, DHA, also known as docosahexaenoic acid. This fatty acid has been proven to be essential for the overall health and cognitive development of a child. DHA is particularly vital for the development of the brain and retina of the fetus during the third trimester till 18 months of the baby’s life. However, according to suggested reports, DHA intake in Indian pregnant women in the third trimester is the lowest when compared to pregnant women in other developing countries. LifeCell’s Omega Score, thus, provides a convenient way to carry out an in-depth analysis to quantify DHA levels that give the baby the necessary health boost essential for their rapidly developing brain. OmegaScore-Prenatal is a self-collection blood test whereas OmegasScore-Newborn is a self-collection breast milk test to make the testing experience comfortable and uncomplicated for pregnant women as well as breastfeeding mothers. ]]> https://biospectrumindia.com/news/97/18590/drdo-designs-ai-based-algorithm-to-detect-covid-19-in-chest-x-rays.html https://biospectrumindia.com/news/97/18590/drdo-designs-ai-based-algorithm-to-detect-covid-19-in-chest-x-rays.html Fri, 07 May 2021 17:00:00 +0530 DRDO (Defence Research & Development Organisation) Centre for Artificial Intelligence and Robotics, with the support of 5C Network & HCG Academics has developed “ATMAN AI”, an Artificial Intelligence algorithm that can detect the presence of COVID-19 disease in Chest X Rays.  The ATMAN AI is an artificial intelligence tool for Chest X-ray screening as triaging tool in Covid-19 diagnosis which is a method for rapid identification and assessment of lung involvement. This will be utilized by 5C Network, India’s largest digital network of Radiologists, with support of HCG Academics across India. Triaging COVID suspect patients using Xray is fast, cost effective and efficient. It can be a very useful tool especially in smaller towns in our country owing to lack of easy access to CT scans. This will also reduce the existing burden on radiologists and make CT machines which are being used for COVID be used for other diseases and illness owing to overload for CT scans. The novel feature namely “Believable AI” along with existing ResNet models have improved the accuracy of the software and being a machine learning tool, the accuracy will improve continually. Chest X-Rays of RT-PCR positive hospitalized patients in various stages of disease involvement were retrospectively analyzed using Artificial Intelligence [Deep Learning & Convolutional Neural Network] models by an indigenously developed deep learning application by CAIR-DRDO for COVID -19 screening using digital chest X-Rays. The algorithm showed an accuracy of 96.73%. With the ongoing second wave of infections, this application can help with a more directed and focused approach. 5C Network, which is connected to over 1,000 hospitals across India, will now make ATMAN available to state-run and private hospitals. ]]> https://biospectrumindia.com/news/97/18581/clevergene-opens-cutting-edge-covid-19-rt-pcr-testing-facility-in-bengaluru.html https://biospectrumindia.com/news/97/18581/clevergene-opens-cutting-edge-covid-19-rt-pcr-testing-facility-in-bengaluru.html Fri, 07 May 2021 00:00:00 +0530 The Gene Lab- Clinical Diagnostic Lab by Clevergene has opened a cutting-edge COVID-19 RT-PCR testing facility in Bengaluru. The ICMR approved lab is deploying automated RNA extraction and high-throughput RT-PCR to deliver up to 3000 tests in a single day.  Patients can walk-in directly to The Gene Lab’s sample collection facility at Indiranagar alongside the option of booking a home collection via www.thegenelab.com. The company has presently amplified its home collection network across the city of Bengaluru to address the burgeoning demand in wake of the lethal second wave of the mutated virus. In spite of the colossal surge in daily cases, the company has managed to achieve a 24 hours turn round time for over 95% of the samples received in their lab. Commenting on the testing facility’s launch, Tony Jose, Co-Founder & CEO, Clevergene, said,  “We have launched a fully-equipped COVID-19 RT-PCR testing facility in Bengaluru to accelerate the testing capacity in the country. By deploying automated RNA extraction and high-throughput RT-PCR to deliver more than 3000 tests on a daily basis, we are confident that we can intensify the identification and isolation process of prospective careers. We want to assure all the citizens of the country that as the leading emissaries of the scientific community, we are warranting the best of technology and genomic innovation to curtail the spread of this virus and sooner or later humanity will emerge triumphant in this war against the virus.” ]]> https://biospectrumindia.com/news/97/18578/voxtur-bio-to-setup-pan-india-ivd-kit-distribution-network.html https://biospectrumindia.com/news/97/18578/voxtur-bio-to-setup-pan-india-ivd-kit-distribution-network.html Thu, 06 May 2021 14:10:00 +0530 Voxtur Bio Ltd, a Mumbai-based In-vitro diagnostics (IVD) company, has rolled out a pan-India plan to expand its IVD kit distribution network. As a part of the strategy, the company will onboard more than 100 marketing professionals across key metros and cities in India to strengthen its order procurement and supply capability. To ramp up its manufacturing strength, the company has set up a 40,000 sq. ft. state-of-the-art manufacturing facility in Vasai on the outskirts of Mumbai with a production capacity of 12 million tests per month. As the IVD market in India is growing at a rapid pace, Voxtur Bio aims to capture the larger market share with its affordable world-class IVD test kits and reagants. In line with the government’s Make In India mission, the company is bolstering its manufacturing and distribution wherewithal to reduce dependence on imports from countries like China. “The IVD market is growing at a faster clip because of the growth of lifestyle ailments and heightened awareness of minimally invasive and non-invasive diagnostic techniques. However, the supply from multinational companies and imports is catering to the IVD demand of only the metro and tier 1 cities while a vast part of the market still remains underserved and underleveraged. With our enhanced manufacturing bandwidth and distribution network, we aim to meet the growing demand with our affordable world-class IVD solutions. Domestically manufactured IVD solutions go a long way in reducing the healthcare cost of the country,” said Dr Veeraal Gandhi, Chairman and Managing Director, Voxtur Bio Ltd. ]]> https://biospectrumindia.com/news/97/18558/neuberg-diagnostics-commences-clinical-operations-in-us.html https://biospectrumindia.com/news/97/18558/neuberg-diagnostics-commences-clinical-operations-in-us.html Tue, 04 May 2021 00:00:00 +0530 Neuberg Diagnostics, headquartered in Chennai, has announced the start of its clinical laboratory operations in North Carolina, US. The laboratory in North Carolina, known as Neuberg Centre for Genomic Medicine (NCGM, Inc) will focus on genomic and molecular testing based on new generation sequencing techniques. It also runs an extensive network of labs in India, South Africa, and the UAE as well. NCGM has introduced COVID-19 molecular testing to detect active SARS CoV-2 virus infections that is of immediate public health priority in North America, along with genome scale testing, such as exome sequencing, which is applicable across a variety of rare genetic disease testing (inherited diseases) from newborn screening to oncology to paediatric care setting. Dr GSK Velu, Chairman & Managing Director, Neuberg Diagnostics, said, “NCGM, USA will act as the laboratory and hub, aiding our operations in North America. Through leveraging our collaborative efforts across our organisation in India, South Africa, and the UAE, and with our external partners, we aim to develop and provide the best-in-class affordable tests. As they are deployed, the accessibility and affordability of the tests will reduce disparity and benefit individuals across the board.” Dr Sandip Shah, Executive Director, Neuberg Diagnostics, said, “NCGM, USA sequencing services will be supported by in-house bioinformatics team and cutting-edge technologies which has been developed in-house, and along with reputed partners. It will also support genetic research by leveraging our own extensive infrastructure in India, South Africa, and the UAE.” Dr Andy Bhattacharjee, CEO, NCGM, US, said, “The setup has comprehensive genomic testing facility allowing large-scale clinical and research projects. With capacity to conduct more than 400 variety of tests, the centre will conduct large-scale clinical diagnostics and genomics projects with greater sample volumes at an unprecedented depth and coverage of the genome.” ]]> https://biospectrumindia.com/news/97/18534/j-mitra-unveils-indias-first-covid-19-neutralizing-ab-test.html https://biospectrumindia.com/news/97/18534/j-mitra-unveils-indias-first-covid-19-neutralizing-ab-test.html Thu, 29 Apr 2021 13:05:00 +0530 J Mitra & Company, based in New Delhi, has launched India’s first Covid-19 Neutralizing Antibody Microlisa Elisa Test its ongoing fight against the corona pandemic. The test kit has cleared all government parameters and received all necessary approvals, including Drug Controller General of India (DCGI) & successful product validation. Virus neutralization remains the gold standard for determining antibody efficacy. Covid-19 Neutralizing Antibody Microlisa Elisa Test is the first commercial laboratory test to detect neutralizing antibodies against SARS-CoV-2, the virus that causes Covid-19.  The test kit will help highlight the efficacy of the vaccines on the human body and the development of the antibodies to fight the virus and help identify potential plasma donors. The test kit has high sensitivity (> 95%) and Specificity (100%). The test identifies individuals who have had recent or prior infection with SARS-CoV-2. Detection of neutralizing antibodies helps us identify its significance for patients as we continue the fight against COVID-19. Focusing on the performance of the test, Jatin Mahajan, Managing Director, shared, "The test kit has high sensitivity (> 95%) and Specificity (100%). It has a shelf life of 12-months; is easy to use; and provides high throughput of 92 tests in 75 minutes.”  ]]> https://biospectrumindia.com/news/97/18506/iiser-bhopal-designs-affordable-oxygen-concentrator-.html https://biospectrumindia.com/news/97/18506/iiser-bhopal-designs-affordable-oxygen-concentrator-.html Mon, 26 Apr 2021 12:00:00 +0530 Indian Institute of Science Education and Research (IISER) Bhopal Innovators have developed a one-of-its-kind oxygen concentrator - Oxycon, to bring a solution to tackle the oxygen shortage crisis amid the second wave of COVID-19.  Appreciating the innovators’ efforts Prof. Siva Umapathy, Director, IISER Bhopal, said, “The device Oxycon has been developed using the open-source technology and material that has helped us to develop the device at low cost, and therefore once approved, it can be used anywhere from small villages to big cities due to its affordability.” The developed device is portable, customizable, and easy to deploy. It has a compressor that takes ambient air and passes it through columns having material named zeolite under an optimized pressure. Two such columns are used in alternate cycles and electronically controlled valves are used for this purpose to make it automatic and provide a continuous oxygen supply. The material, zeolite, absorbs nitrogen from the air and throws it back to the atmosphere, hence the concentration of oxygen increases in the air at the outlet. The valve controls are achieved using a programmed microcontroller based circuit. Speaking about further improving and commercializing the innovation, Dr. Mitradip Bhattacharjee, Assistant Professor, Department of Electrical Engineering and Computer Science, IISER Bhopal, said, “This system prototype has already been developed and compared with the commercial systems currently available at the market and we have received positive outcomes. We are actively looking for industrial collaborations to further improve and manufacture the system at a larger scale and to deploy it after necessary testing and approvals.” ]]> https://biospectrumindia.com/news/97/18492/c-camp-opens-online-marketplace-platform-to-ramp-up-covid-19-diagnosis.html https://biospectrumindia.com/news/97/18492/c-camp-opens-online-marketplace-platform-to-ramp-up-covid-19-diagnosis.html Fri, 23 Apr 2021 10:00:00 +0530 Anchored by Centre for Cellular and Molecular Platforms (C-CAMP) on behalf of Bangalore Life Sciences Cluster and supported by Rockefeller Foundation, Indigenization of Diagnostics program or CCAMP-InDx in conjunction with National Biomedical Resources Consortium (N-BRIC), has enabled mass-scale availability of indigenously developed, ICMR/DCGI-approved COVID-19 diagnostic kits for Govt and private diagnostic labs facing any shortfall due to the current Tsunami of cases across India. These kits are now directly accessible through the CCAMP-InDx deployed Marketplace platform designed pro-bono by TCS, that aims to connect kit buyers immediately with manufacturers. The CCAMP-InDx Marketplace (web portal developed and supported by TCS) is up and running and companies that are on the portal can register their products, create "wants" and negotiate with suppliers. At this point in time 200+ products are registered on the portal. CCAMP now invites individual diagnostic labs, diagnostic lab chains, hospitals or pharma companies to join the portal. As the country reels under this vicious Second Wave, CCAMP-InDx and N-BRIC can lead the fight back with resources for a vastly improved availability of diagnostic kits and enhanced connectivity between public healthcare system and Indian kit developers. The Indx-Market Place is now open for immediate business. Both gold standard RT-PCR and antigen/antibody for serological surveys are available under these programs while the Marketplace is now open for access by all potential kit buyers.   ]]> https://biospectrumindia.com/news/97/18475/iit-kgp-commercialises-covid-19-diagnostic-device-covirap.html https://biospectrumindia.com/news/97/18475/iit-kgp-commercialises-covid-19-diagnostic-device-covirap.html Wed, 21 Apr 2021 10:00:00 +0530 IIT Kharagpur (Kgp) has successfully commercialized its flagship healthcare product – COVIRAP – the novel diagnostic technology for infectious diseases including COVID-19 and beyond. The product developed by lead researchers Professor Suman Chakraborty, Dr. Arindam Mondal and their research group has been licensed for commercialization to the Rapid Diagnostic Group of Companies, India and Bramerton Holdings LLC, USA. Bramerton Holdings has signed a record deal for securing global rights for commercially disseminating the COVIRAP technology developed at IIT Kharagpur in various geographical locations outside the territory of the Indian subcontinent. Rapid Diagnostic has also initiated adapting the COVIRAP technology platform for COVID-19 and tuberculosis, in collaboration with IIT Kharagpur. The research team has now developed a more advanced version of COVIRAP using a step-wise isothermal nucleic acid testing technology for the rapid diagnostics of pathogenic infections including SARS-CoV-2 in individuals. The COVID-19 diagnostic test can be conducted directly from human swab samples in the portable device developed by the team, without requiring any separate facility for RNA extraction. The results can be made available within 45 minutes of obtaining the patient sample. The kit has also been also supplemented with a free smartphone app to facilitate unambiguous results interpretation and automated dissemination to the patients. Commercialization and use in the USA and Europe under the Emergency Use Authorization (EUA) process are currently underway. Both the Rapid Diagnostic Group in India and Bramerton Holdings in the USA, in association with IIT Kharagpur, have already identified the key resources towards establishing the reagent supply chain, kit and device manufacturing in entirety under a ‘Make in India’ initiative with complete import substitution. ]]> https://biospectrumindia.com/news/97/18472/exalta-develops-portable-ventilator-with-inbuilt-oxygen-concentrator.html https://biospectrumindia.com/news/97/18472/exalta-develops-portable-ventilator-with-inbuilt-oxygen-concentrator.html Tue, 20 Apr 2021 17:40:00 +0530 New Delhi-based Exalta has developed a portable mini ventilator with an inbuilt oxygen concentrator. A water-based pure oxygen concentrator, the mini ventilator provides 1-8 litres of oxygen per minute. All that one needs to do is put water inside the ventilator and rest it’ll process on its own. It creates pure oxygen through the water like other oxygen concentrators found in the market based on normal pressure swing adsorption (PSA). They consist of a pressure exhaust mechanism that draws oxygen from normal air with a zeolite process. Zeolite is the process that purifies the air and removes other gases into a compressor. An effective way to process oxygen through water, consumption of this air for 15 minutes, shows an increase in oxygen level, flow rate, perfusion index (PI) level, and other functions in the body. It also helps in treating health problems like Alzheimer's, diabetes, toxicity, among others. Speaking about the launch Ashutosh Verma, Founder Exalta India, said, “This product works as an oxygen concentrator, compressed oxygen, and mini ventilator which is 100 per cent made in India with no foreign components used. It’s portable, handy, and easy to carry. In the last three days, we have got more than 200 orders and also, we have started manufacturing oxygen concentrators for hospitals and nursing homes. The machines use pressure swing adsorption (PSA) technology and come in three variants viz 50 ltrs, 100 ltrs, and 200 ltrs per minute.” ]]> https://biospectrumindia.com/news/97/18461/drdo-designs-spo2-based-supplemental-oxygen-delivery-system.html https://biospectrumindia.com/news/97/18461/drdo-designs-spo2-based-supplemental-oxygen-delivery-system.html Mon, 19 Apr 2021 17:00:00 +0530 Defence Research and Development Organisation (DRDO) has developed SpO2 (Blood Oxygen Saturation) supplemental Oxygen Delivery System for soldiers posted at extreme high-altitude areas. Developed by Defence Bio-Engineering & Electro Medical Laboratory (DEBEL), Bengaluru of DRDO, the system delivers supplemental oxygen based on the SpO2 levels and prevents the person from sinking in to a state of Hypoxia, which is fatal in most cases, if sets in. This automatic system can also prove to be a boon during the current Covid-19 situation. The system reads SpO2 levels of the subject from a wrist-worn pulse oximeter module through wireless interface and controls a proportional solenoid valve to regulate the oxygen supply to the subject. The oxygen is delivered from a lightweight portable oxygen cylinder through nasal nares. The system is a boon in the current pandemic as it can be used in the household for moderate Covid patients for Oxygen flow therapy with flow controlled at 2/5/7/10 lpm flow. With its availability and simple to use facility by a common person, the system shall greatly reduce the workload and exposure time of doctors and paramedics to monitor the SpO2 levels of the patient. ]]> https://biospectrumindia.com/news/97/18456/indo-swiss-collaboration-results-in-novel-sweat-based-diagnostic-technology.html https://biospectrumindia.com/news/97/18456/indo-swiss-collaboration-results-in-novel-sweat-based-diagnostic-technology.html Mon, 19 Apr 2021 09:00:00 +0530 A study carried out by a team of researchers led by an alumnus of the Indian Institute of Technology (IIT) Hyderabad, Dr Brince Paul, has resulted in the development of a new device that can generate sweat at resting and detect markers and transmit through a mobile phone. This sweat based non-invasive point of health diagnosis technology would be an alternative to blood based invasive diagnosis. As a postdoctoral researcher, Dr Paul conducted this study in the Écolepoly technique fédérale de Lausanne (EPFL), Switzerland. Making such a non-invasive tool available could accelerate medical research to progress in this field. For example the direct chloride level in sweat is useful for screening cystic fibrosis. Similarly, potassium level correlated with plasma for ambulatory monitoring and sweat quality control, pH as an indicator of metabolic alkalosis, glucose for screening pre-diabetic conditions or monitoring tool for diabetes, and lactate for assessing metabolic efficiency etc., are some of them. Researchers are presently in the process of accommodating more markers from the sweat and other fluids (surface needle based) to make it useful for real time daily usage purposes including exercise condition (which includes ions, metabolites such as glucose and lactate, and different proteins). “The actual clinical device innovation can be realised when we collaborate effectively with engineers, clinicians, product designers, and along with an industry partner towards a common solution by allowing them to stand their own experts platform”, said Dr Paul. ]]> https://biospectrumindia.com/news/97/18382/medtronic-unveils-engineering-and-innovation-centre-in-hyderabad.html https://biospectrumindia.com/news/97/18382/medtronic-unveils-engineering-and-innovation-centre-in-hyderabad.html Wed, 07 Apr 2021 13:00:00 +0530 Medtronic plc has announced the inauguration of its newly expanded state-of-the-art Medtronic Engineering and Innovation Center (MEIC) in Hyderabad. The research and development facility was inaugurated by KT Rama Rao, Minister for Municipal Administration & Urban Development, Industries & Commerce, and Information Technology and his team of officials from the Government of Telangana. The 150,000 square feet center employs engineers currently in the areas of software development and testing, test automation, mechanical design, analysis and hardware. With this expansion, MEIC aims to leverage the sizeable pool of diverse and skilled talent in India to continue its pioneering work in the medical technology space and add further to Medtronic’s 150+ patents and 400+ IP disclosures globally that MEIC has been a part of. Speaking at the inauguration function, Madan Krishnan, vice president and managing director, India Medtronic Pvt Ltd., said, “Hyderabad is positioned to become India’s hub for technology companies across the world. We see enormous potential in energizing the medical devices innovation ecosystem in the country. The R&D team in India is a key contributor to Medtronic’s global product development. The opening of the new site is an important milestone for us as it serves as a critical component in strengthening our global R&D organization and will also drive innovation and growth.” ]]> https://biospectrumindia.com/news/97/18365/revised-ppo-to-boost-domestic-medical-device-manufacturing-in-line-with-make-in-india-.html https://biospectrumindia.com/news/97/18365/revised-ppo-to-boost-domestic-medical-device-manufacturing-in-line-with-make-in-india-.html Mon, 05 Apr 2021 12:50:00 +0530 The revised notice issued by The Department of Pharmaceuticals (DoP) on the Public Procurement Order (PPO) on March 25, 2021, where they have incorporated 19 medical devices in the revised guidelines of the PPO will boost domestic medical device manufacturing by strengthening ‘Make in India’ and is estimated to reduce imports bill by approx Rs 4000 crore. This comes as a great relief to the 85 per cent import dependence forced upon India and an ever-increasing import bill of over Rs 42000 crore. Rajiv Nath, Forum Coordinator, AiMeD said, “This is a real boost to Make in India. This single strategic action will help boost domestic manufacturing imports bill reduction by nearly 10 per cent so approximately Rs 4000 Crore impact is foreseen.” While MNCs/overseas global investors are very welcome to Make in India, the reality is that very few have made efforts to put up greenfield projects in the last 10 years and the ones that have done so and other Indian entrepreneurs who have bravely invested and competed with imports in an ecosystem that’s favoured imports and made India over 85 per cent imports dependent need to be applauded.  The day has arrived to remove the digressive policies of encouraging and relying heavily on imports to meet India's needs for medical devices,” stated Mala Vazirani, Executive Director, Transasia and Jt Coordinator AiMeD, Legal Affairs.  “Covid-19 has shown the spirit of Indian entrepreneurs to Make in India rather than import into India. When imports got disrupted, specific devices detailed with quantified production shortages and a focused Inter-Ministry Group coordinating with domestic manufacturers via AiMeD had addressed production bottlenecks and challenges so that not only capacity got utilised but also ramped up rapidly. This spirit needs to be fanned not doused by seeking roll back of these initiatives” stated Rajiv Chibber, Vice President, SMT and Jt Coordinator Govt Affairs, AiMeD.  Such supporting policies are needed and need to be expanded to other medical devices so that Indian Medical Devices Industry can make quality healthcare accessible and affordable for the common masses,” concluded Nath. ]]> https://biospectrumindia.com/news/97/18344/mtai-voices-concern-on-public-procurement-policies-leading-to-chaos-confusion.html https://biospectrumindia.com/news/97/18344/mtai-voices-concern-on-public-procurement-policies-leading-to-chaos-confusion.html Tue, 30 Mar 2021 15:25:00 +0530 MTaI feels disappointment that despite the assurance of the Ministry of Commerce that no PPOs will come without proper analysis of local market capacity, they are still seeing such a notice, which on first reading, seems to be made without doing a proper due-diligence on. A blanket declaration is made that 19 HSN codes will be procured from only class I local suppliers, overlooking the fact that these codes are not monolithic. Each of these codes may comprise of many categories several of which may not even be manufactured in India. MTaI has also observed that the list of manufacturers that are indicated in the order, fails to mention some of the globally renowned manufacturers who already have a strong manufacturing foot-print in India as well as a significant share of the market. MTaI prima facie feel that this will be a regressive step, as this could further push down FDI investment which has just picked up pace primarily due the undespairingly spirit of the global investors. The global companies contribute most of the investment which comes into manufacturing in India. Another important reality that needs to keep in mind is that many medical devices have a high value but are produced in low volumes. It may therefore not be economically viable to manufacture all devices in a single geographical area. That is why even countries where medical device manufacturing is highly developed have significant percentage of import dependence. MTaI would also like to underline the fact that central government hospitals also cater to the under privileged. And changing the quality of inputs that they have been getting without a high-quality due diligence puts all their clients to avoidable risk.   ]]> https://biospectrumindia.com/news/97/18313/saifee-hospital-updates-clinical-specialty-equipment-for-kidney-stone-treatment.html https://biospectrumindia.com/news/97/18313/saifee-hospital-updates-clinical-specialty-equipment-for-kidney-stone-treatment.html Wed, 24 Mar 2021 13:50:00 +0530 Saifee Hospital, a renowned multi-specialty healthcare facility in Mumbai, updated its clinical specialty equipment with the installation of Thulium fiber laser (TFL), a revolutionary technology in kidney stone treatment.  The hospital earlier offered the more commonly used Holmium: YAG laser. The recent upgrade is seen as a game changer in the field, offering a more efficient, flexible, and safer means to administer laser treatment.   TFL is now widely seen as a vast improvement on Holmium: YAG laser because of its higher efficiency that offers multiple additional benefits. These include a four-fold higher absorption of coefficient in water, lower energy consumption, smaller operating laser fibres, and higher maximal pulse repetition rate. In layman’s terms, it makes the TFL 1.5–4 times faster in breaking the kidney stones. This makes it particularly beneficial in ureteroscopy. Commenting on the installation  Dr Hiren S Sodha, Senior Consultant Urologist, Saifee Hospital, Mumbai  said, “Thulium fiber laser is widely seen as a ground-breaking development in the field of kidney stone treatment which allows for far more effective medical care. The highly precise action of the laser also reduces patient morbidity. As a laser tech, it is safer and highly efficient and is unlikely to need long hospitalisation. Hence, it can indirectly help save treatment cost.” ]]> https://biospectrumindia.com/news/97/18304/olympuss-ai-diagnostic-support-system-comes-up-in-aig-hyd.html https://biospectrumindia.com/news/97/18304/olympuss-ai-diagnostic-support-system-comes-up-in-aig-hyd.html Tue, 23 Mar 2021 13:15:00 +0530 Olympus Corporation recently conducted a virtual seminar on Endoscopic AI Diagnosis Education in India. With the aim to make people’s lives healthier, safer and more fulfilling as a global MedTech firm, the company has established an AI diagnostic support system at the Asian Institute of Gastroenterology (AIG) based in Hyderabad and also initiated a research and training project for the doctors and specialists at the major medical institution. Olympus aims to assist in the development of physicians and promote the use of endoscopic diagnostics. There is a severe shortage of doctors who can conduct precision diagnostics with endoscopes, which are essential for early detection and treatment of cancer. Through the project, prominent doctors have trained AIG doctors to be equipped with the techniques needed to detect diseases and differential diagnosis via colonoscope, as well as prepared them to pass on the knowledge and instruct the next generation of endoscopists in India. Olympus Corporation has been conducting the endoscopic education since October 2020 with support from the Japanese Ministry of Internal Affairs and Communications to train doctors in India and neighbouring countries and to contribute to the popularisation and development of endoscope diagnostics using the latest AI technology. Present at the seminar, Dr Goutham Reddy Katukuri, Consultant – Gastroenterology of AIG Hospitals said, “Visual diagnosis of colorectal polyps may improve the cost-effectiveness of colonoscopy and reduce complications of polypectomy. A more precise diagnosis can be expected in the coloscopic inspection using AI diagnostic support system, and the difference in the diagnosis among observers may be corrected.” Speaking about this co-operation, Satoshi Hemmi, Ministry of Internal Affairs and Communications, Japan,  commented, “The aim is to contribute to the introduction and dissemination of Japan’s endoscopic AI diagnostic support system to India and neighbouring countries in response to the social issue of increasing cancer prevalence in India.” ]]> https://biospectrumindia.com/news/97/18300/bloom-ivf-launches-baufici-genetics-lab-on-world-down-syndrome-day.html https://biospectrumindia.com/news/97/18300/bloom-ivf-launches-baufici-genetics-lab-on-world-down-syndrome-day.html Mon, 22 Mar 2021 18:50:00 +0530 On World Down Syndrome Day, Bloom IVF clinics in India has launched BAUFICI Genetics Laboratory with advanced state-of-the-art facilities to support successful IVF treatments.  All latest genetic tests including NIPT are now available at BAUFICI Genetics to detect abnormalities at different levels of pregnancy.  Every year on March 21, World Down Syndrome Day is observed to create awareness about Down syndrome. It is a condition in which a child is born with an extra 21st chromosome. Many genetic abnormalities including chromosomal abnormalities such as Down syndrome can be detected with genetic testing during pregnancy. Other disorders that can be detected include cystic fibrosis, muscular dystrophy, haemophilia, polycystic kidney disease, sickle cell disease, and thalassaemia. “The fear that engulfs every expectant parent these days, is the outcome of pregnancy: whether the baby will be healthy or have any defects, unfortunately, if the genetic problem is detected late, then it would lead to the birth of a physically and/or cognitively challenged child,” said Dr Hrishikesh Pai Gynaecologist and Infertility Specialist, Bloom IVF, Fortis Hospital GK-2 New Delhi & Lilavati Hospital Mumbai. “The next-generation sequencing is designed to employ massively parallel strategies to produce large amounts of DNA sequencing, from multiple samples at very high-throughput and at a high degree of sequence coverage. NGS also is more effective in assessing mosaicism in embryos, following PGTa,” said Dr Nandita Palshetkar, Gynaecologist & Infertility Specialist, Bloom IVF, Fortis Hospital GK-2 New Delhi & Lilavati Hospital Mumbai.    ]]> https://biospectrumindia.com/news/97/18294/tatamd-anderson-diagnostics-collaborate-to-scale-up-covid-19-kit-production-.html https://biospectrumindia.com/news/97/18294/tatamd-anderson-diagnostics-collaborate-to-scale-up-covid-19-kit-production-.html Mon, 22 Mar 2021 13:50:00 +0530 Tata Medical and Diagnostics (TataMD) has announced that it has entered into a wide-ranging clinical collaboration with Chennai-based Anderson Diagnostics & Labs (ADL), to standardise the indigenously - developed TataMD CHECK in a bid to slow down the rate of new infections.  The collaboration with clinical experts of ADL has helped ensure that the ‘Made-in-India’ TataMD CHECK diagnostic kit can be scaled rapidly with ADL having already successfully conducted over 10,000 COVID tests using this new, DGCA approved ICMR guidelines, novel diagnostic solution based on Feluda CRISPR Platform. “Our clinical partnership with Tata MD will help support the transformation of COVID testing to arrest the emergence of a second wave in India and around the world,” said Dr Srinivasaraman, Director, Anderson Diagnostics and Labs. “TataMD CHECK’s ability to perform using inexpensive lab equipment like standard thermocyclers will be a boost for small labs in tier II/III towns and villages to start COVID testing locally,” said Dr Anand Krishnamoorthy, Managing Director, Anderson Diagnostics. “Working with the exceptional team at Anderson Diagnostics has demonstrated the impact that a new technology-based product like TataMD CHECK can have on strengthening our COVID testing capacity and access to testing in remote areas. Tata’s clinical collaboration with Anderson Diagnostics will only drive advances in the diagnostic space of COVID-19 as the pandemic continues,” said Girish Krishnamurthy, MD & CEO, Tata Medical and Diagnostics. Strong strategic partnerships allow each partner to bring in their strengths, creating a synergy that augments the efforts in the battle against COVID. The partnership between Tata MD and Anderson Diagnostics and Labs will act as an enabler to optimise the delivery of the COVID tests, advance diagnosis for emerging pandemic and diseases, create more value for the people and allow easier access to the tests. Together with its partners, TataMD will drive change in healthcare through the latest technology and provide COVID-19 testing wherever and whenever needed. ]]> https://biospectrumindia.com/news/97/18283/resmed-brings-ectosenses-onesleeptest-for-sleep-apnea-diagnosis-in-india-.html https://biospectrumindia.com/news/97/18283/resmed-brings-ectosenses-onesleeptest-for-sleep-apnea-diagnosis-in-india-.html Fri, 19 Mar 2021 16:15:00 +0530 ResMed, a global leader in digital health, is now distributing the onesleeptest by Ectosense in India to help patients and physicians diagnose millions of Indians who suffer from undiagnosed sleep apnea. onesleeptest by Ectosense is a disposable, multi-night use test based on peripheral arterial tonometry technology with a built-in NightOwl sensor (driven by Photoplethysmography-PPG technology) to measure key indicators such as heart rate, oxygen desaturation and body movements to determine sleep quality. The onesleeptest device accurately tracks and delivers results by a certified sleep specialist within 3-5 working days, making it an ideal solution to test sleep quality from the comfort and safety of your home during the pandemic. ResMed is launching a three-part ‘onesleeptest’ service in conjunction with World Sleep Day (March 19), includes the home sleep test, along with sleep scoring by a leading sleep physician in India and sleep coach consultancy to support patients’ journey from diagnosis to therapy.  “Home sleep tests are reliable, comfortable and are even recommended by the American Society of Sleep Medicine,” said Seema Arora, Marketing Manager, Asia & LatAm – ANZ, ResMed. “We believe home sleep tests are essential to helping diagnose more people who suffer from sleep apnea, especially at a time when social distancing and contactless diagnosis is encouraged.” ResMed has partnered with Indian stand-up comedian, writer, presenter, and actor Jeeveshu Ahluwalia, who himself is a sleep apnea patient with type 2 diabetes and obesity to underline the need for testing and importance of sleep quality.   onesleeptest allows a patient to assess their results via email by a certified sleep specialist at ResMed, along with suitable therapies and treatments. ]]> https://biospectrumindia.com/news/97/18280/roche-unveils-test-for-sars-cov-2-mutations.html https://biospectrumindia.com/news/97/18280/roche-unveils-test-for-sars-cov-2-mutations.html Thu, 18 Mar 2021 19:05:00 +0530 Roche has announced the launch of the cobas® SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research use only laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for healthcare systems in making appropriate measures to combat COVID-19. “Viruses naturally evolve over time. While most mutations do not have a clinical impact, some variants need to be tracked carefully as they seem to spread more easily and quickly,” said Thomas Schinecker, CEO, Roche Diagnostics. “Continued surveillance is essential for public health. Our latest solution provides laboratories a fast and efficient way to investigate these variants found in infected individuals and the potential impact on existing therapies, vaccines and tests.” The cobas SARS-CoV-2 Variant Set 1 Test runs on the widely available, high-volume cobas® 6800/8800 Systems. Pre-optimised assay design, ready-to-use test cassettes and predefined software parameters enable laboratories to reduce testing complexity and increase walkaway time. It is important to note that Roche has confirmed its existing diagnostic tests to detect SARS-CoV-2 are not affected by known mutations and remain accurate and effective in detecting active infections. The company is conducting assessments on a regular basis and will continue to monitor as new variants arise. ]]> https://biospectrumindia.com/news/97/18279/iit-kanpur-launches-inspirational-book-the-ventilator-project-.html https://biospectrumindia.com/news/97/18279/iit-kanpur-launches-inspirational-book-the-ventilator-project-.html Thu, 18 Mar 2021 18:50:00 +0530 ‘The Ventilator Project’, a story of how a world-class ventilator was designed and built at IIT Kanpur was released at a function by Dr K Radhakrishnan, Chairperson, BoG, IIT Kanpur and Former Chairperson, ISRO.  Ramesh Pokhriyal ‘Nishank’, Minister of Education, Government of India sent his wishes and congratulated the IIT Kanpur team and the task-force on their efforts to the nation and to the authors on their documentation of the incredible story of Atmanirbhar Bharat. The book is a gripping testament to the sheer will and collaborative efforts of Nikhil Kurele and Harshit Rathore who came together to build a world-class ventilator in just 90 days when the COVID-19 pandemic struck India. Their story is now captured in the thrilling pages of the book ‘The Ventilator Project - How the IIT Kanpur Consortium Built a World-class Product during India’s COVID-19 Lockdown’ by authors Srikant Sastri and Amitabha Bandyopadhyay. Dr Radhakrishnan, said, “The Ventilator Project is not only a case-study for entrepreneurs or the start-up eco-system of India but also for our premier educational institutions and the critical role they will have to play in the Atmanirbhar movement whilst strengthening our economy.” Prof Abhay Karandikar, Director, Indian Institute of Technology Kanpur, who penned the foreword for the book, said, “The Ventilator Project is one example that puts IIT Kanpur and India on the map of global innovation in both manufacturing and business.” ‘The Ventilator Project - How the IIT Kanpur Consortium Built a World-class Product during India’s COVID-19 Lockdown’ is available on e-commerce sites and at all leading bookstores. ]]> https://biospectrumindia.com/news/97/18272/samsung-medison-and-intel-partner-to-improve-anesthesia-delivery.html https://biospectrumindia.com/news/97/18272/samsung-medison-and-intel-partner-to-improve-anesthesia-delivery.html Wed, 17 Mar 2021 05:25:00 +0530 Samsung Medison and Intel are collaborating on NerveTrack™, a real-time nerve tracking ultrasound feature that helps anesthesiologists identify nerves in a patient’s arm to help administer anesthesia quickly and accurately. Leveraging the Intel Distribution of OpenVINO toolkit for computer vision and annotation, Samsung Medison’s NerveTrack™ can potentially reduce scanning time by up to 30 percent. Ultrasound-guided regional anesthesia (UGRA) is becoming standard practice for needle-based interventions, including vascular access and peripheral nerve block. However, even with UGRA, it can be difficult for anesthesiologists to correctly identify nerves, which can be as small as 2 millimeters in diameter, or to see the needle tip properly. NerveTrack can automatically identify nerves in real time for anesthesiologists — reducing the possibility of complications while improving workflows. NerveTrack was developed based on Intel’s OpenVINO toolkit. It uses inference to detect and identify the location of a nerve area in real time during an ultrasound scan, improving the treatment workflow for anesthesiologists. To train Samsung’s proprietary real-time algorithm that automatically detects nerves in ultrasound images, a significant amount of clinical ultrasound data was required. And with Intel’s OpenVINO CVAT (Computer Vision Annotation Tool), the total volume of training data increased up to 7 times, leading to improved accuracy of more than 20 percent. ]]> https://biospectrumindia.com/news/97/18258/experts-recommend-harmonising-medtech-industry-regulations-standards-.html https://biospectrumindia.com/news/97/18258/experts-recommend-harmonising-medtech-industry-regulations-standards-.html Mon, 15 Mar 2021 18:55:00 +0530 Health and Pharmaceutical Manufacturing & Medical Devices Committee, PHDCCI in association with Department of Pharmaceuticals, Ministry of Chemicals & Fertilisers, Govt of India recently organised the fourth series of Self Sufficiency in Medical Technology on Optimum Regulations, Quality Standards, Controls for MedTech on March 12, 2021. The webinar was graced with the presence of Dr N Subramanian, Chair, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals, Dr Sameer Gupta, Co-Chair, Health Committee, PHDCCI & Dr Harvinder Popli, Director, Delhi Pharmaceutical Science & Research University. The session was moderated by Vivek Seigell, Assistant Secretary-General, PHDCCI. Anil Zainulbhai, Chairperson, Quality Council of India said QCI looks forward to collaborating and working together with CDSCO and BIS for further standardisation for the MedTech industry. He further mentioned QCI is currently focusing on moving faster towards improving standards and making testing capacity cheaper for the MSMEs sector in India. Dr Subramanian said that defects or disturbances in the functions of medical devices may expose patients to serious risks which is particularly true for devices that transfer energy or pharmaceuticals to patients; hence the safety standards must be high for all medical devices and the devices shall be safe, reliable and well suited for their intended purposes. Dr Gupta said that the emphasis should be on quality and ease of getting regulatory approvals. He mentioned that MedTech has shown very tremendous growth in the last few years and urged that all safety standards must be very high for all medical devices as it deals with patient life. Sumit Kumar, Scientist-C- Medical Equipment & Hospital Planning Department, Bureau of Indian Standards mentioned that BIS is in close association with other standards developing organisations to make one nation one standard. Manish Airan, AVP- Quality & Regulatory, Transasia Bio-medicals Limited said that better co-ordination and co-operation is expected among all the three bodies, CDSCO, BIS and QCI. This will help to reduce redundancy, ease the adherence and the effective implementation of regulations to all the medical device manufacturers. He further mentioned that public procurement agencies including GEM, need to be educated on the Indian standards so that the need of CE and US FDA to be eliminated.” Dr Rajiv Chhibber, Vice President, External Affairs, Sahajanand Medical Technologies Pvt Ltd, said, “The need is to be looking at harmonising Indian standards and international standards for ease of doing business, focus on developing domestic prowess in key areas like laboratory infrastructure, innovation, R&D and manufacturing. Dr Popli in her closing remarks mentioned that the state government should also set up a funding scheme to support the industry.    ]]> https://biospectrumindia.com/news/97/18247/spicehealth-launches-rt-pcr-tests-at-rs-499.html https://biospectrumindia.com/news/97/18247/spicehealth-launches-rt-pcr-tests-at-rs-499.html Fri, 12 Mar 2021 00:00:00 +0530 SpiceHealth has announced the launch of the country’s cheapest Real-Time Polymerase Chain Reaction (RT-PCR) tests for general public at just Rs 499. SpiceHealth has also tied up with SpiceJet to offer a special price of Rs 299, which is one-third of the prevailing market rate, for its passengers who wish to get the crucial COVID-19 test done and thus contributing to making flying even more safe and convenient. In the first phase, the company will make its testing facility available for the general public in two of the most affected cities in India - Mumbai and Delhi. SpiceHealth will also allow sample collection from the comfort of their home at a nominal charge. Customers will also have the option to book online appointment and get themselves tested at the nearest SpiceHealth mobile lab. SpiceHealth’s mobile labs are accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) and Indian Council of Medical Research (ICMR).  Avani Singh, CEO, SpiceHealth said, “We are proud to extend our quick, seamless and smooth testing facility to the public at large in Mumbai and Delhi, to start with, and we strongly believe that testing remains as important as ever in our fight against this pandemic as that’s the only way to quickly identify, isolate and treat those infected.” ]]> https://biospectrumindia.com/news/97/18243/fortis-escorts-heart-institute-recommends-calcium-scoring-test-to-predetermine-heart-attack-susceptibility-.html https://biospectrumindia.com/news/97/18243/fortis-escorts-heart-institute-recommends-calcium-scoring-test-to-predetermine-heart-attack-susceptibility-.html Wed, 10 Mar 2021 19:30:00 +0530 Doctors at Fortis Escorts Heart Institute are emphasising the importance of the ‘Calcium Scoring Test’ – a simple test which detects the risk of future heart attacks. Through the test, the amount of calcium in the coronary artery is determined via a specialised CT imaging – confirming the total area being occupied in the coronary artery by the calcium deposits and their density. The test enables a direct visualisation of the amount of calcium deposits in coronary arteries. A zero score means no calcium is seen, suggesting a low probability of heart attack during next decades. Higher the score, higher is the risk of a heart disease. A score of 100-300 means moderate risk, and a score higher than 400 may be an indicator of blockage in the coronary artery.  Dr Ashok Seth, Chairman - Fortis Escorts Heart Institute said, “Calcium scoring is a newer method to predict the risk of heart attack in future and the purpose of detecting calcium in arteries is to customise the lifestyle and reduce this risk.” Dr Peeyush Jain, Director, Non- Interventional Cardiology and HOD - Preventive Health Check, Fortis Escorts Heart Institute, said, “It is painless, safe and carries low risk of side effects. Calcium scoring is a new method to fine-tune the risk and to devise methods to prevent further progression of blockages of arteries.” Dr Mona Bhatia, Director & HOD - Radiology, Fortis Escorts Heart Institute, said, “Calcium Scoring is now incorporated in the guidelines globally to enhance the risk assessment and treatment. This scan is useful for the patient who is thought to have an uncertain risk for heart disease. It also motivates a lot of people with moderate heart disease risk to make lifestyle changes for the better.”   ]]> https://biospectrumindia.com/news/97/18213/fujifilm-india-unveils-battery-powered-portable-x-ray-device.html https://biospectrumindia.com/news/97/18213/fujifilm-india-unveils-battery-powered-portable-x-ray-device.html Thu, 04 Mar 2021 17:55:00 +0530 Fujifilm India Private Limited has announced the launch of Fujifilm’s first portable X-ray device that can easily be used in environments where space and resources are limited, providing quick and easy access to diagnostic imaging through its lightweight, battery-powered PORTABLE X-RAY UNIT FDR Xair XD2000. Fujifilm has created this new style of ultralight, compact, portable, and battery powered X-ray device to be both functional and ergonomic with a modern and stylish appearance for usage in the various medical treatment settings ranging from patients’ homes, in elder-care facilities, in emergencies care setups, at natural disaster sites, military field hospitals, sports medical facilities, coal mines, veterinary applications etc, to serve patients with extremely reduced mobility, thereby giving more freedom in X-Ray imaging by giving access to otherwise difficult scenarios. FDR Xair can be used in combination with Fujifilm FDR D-EVO II Flat Panel Detector for a portable, high image quality, low dose X-ray examination. The aforementioned detector coupled with the virtual grid, an image processing software that corrects for the effects of scatter radiation that otherwise reduce image contrast and clarity, thereby creating high-quality images and reducing the radiation dose to which patients are exposed too. Commenting on the announcement Haruto Iwata, Managing Director, Fujifilm India said, “With the option of conducting diagnosis and screening of tuberculosis at any given location, our new mobile FDR Xair system will provide the much-needed screening solution at any given point of time anywhere.” Chander Shekhar Sibal, Senior Vice President, Fujifilm India said, “With our new FDR Xair, patients will benefit from community imaging and the radiology services in hospitals will also experience a corresponding reduction in workload.”   ]]> https://biospectrumindia.com/news/97/18209/indigital-technologies-launches-kribado-hand-held-screening-device.html https://biospectrumindia.com/news/97/18209/indigital-technologies-launches-kribado-hand-held-screening-device.html Thu, 04 Mar 2021 15:40:00 +0530 Indigital Technologies LLP, a leading research-based technology company that is inspired by pharmaceuticals and driven by healthcare has launched Kribado, a hand-held screening device. Kribado is the next generation behaviour setting and risk stratification device for healthcare companies and healthcare practitioners (HCP). Kribado will assist healthcare practitioners in treating care seekers by implementing a pre-admission level. It is a non-invasive screening device that right-away analyses the patient's condition and provides a risk score while the patient is in the waiting room. By using this screening machine, clinics and hospitals can triage the patients to the relevant procedures or treatments by early identification of risk as well as the degree of risk. Speaking about the launch of Kribado, Hiren Dhuvad, Chief Executive Officer, Indigital Technologies LLP, said, “The system is designed to eliminate the chances of data collection errors by structuring each screen, making sure it is easy to use with a consistent flow of data. Our platform is internationally adopted and simple to use. We are changing how doctors treat patients by providing seamless technology solutions for clinics and hospitals to make the experience connected, more efficient and cost effective.” Kribado operates using AI and risk calculating algorithms trained on perfect human data. The device has a small touch-screen connected to an embedded printer. While it alerts the care providers to potential behavioural risk factors of all patients in waiting areas, it also gives each company an accurate overview of their phase IV studies, surveys and in-clinic camps. ]]> https://biospectrumindia.com/news/97/18187/fujifilm-india-unveils-mobile-digital-radiology-system.html https://biospectrumindia.com/news/97/18187/fujifilm-india-unveils-mobile-digital-radiology-system.html Mon, 01 Mar 2021 18:20:00 +0530 Fujifilm India Private Limited has announced the launch of its mobile digital radiology system – FDR nano. Offering high-resolution imaging with low X-ray doses in healthcare settings, this new digital radiology technology enables a noise reduction circuits that in turn, improves the granularity of low-density regions, and achieves high image quality. The lightweight and compact FDR Nano has achieved approximately 80 per cent reduction in its total weight as compared to traditional mobile X-rays. The high-performance built-in Li-on battery enables 12 hours of continuous use at 20 shots per hour and radiology can be performed even when the battery is empty by simply using the ac power cord. By combining it with Fujifilm’s FDR D-EVO II DR cassette, high-quality X-ray images can be acquired even at a low dose. FDR Nano offers intergrade platform for AI within and outside result options, thereby revolutionising the radiology workflow. It offers a broader platform beyond X-ray department eg ORs and ERs where quick decisions are the essence for saving the life of critical patients. Commenting on the announcement Haruto Iwata, Managing Director, Fujifilm India said, “With our new technology, we aim to provide the much-needed ease to the healthcare professionals, with the option of various movements such as intuitive arm handling and free spin and slide, virtual grid software which will decrease the image contrast resulting in high-resolution images, noise cancellation circuit, and energy saving. This revolutionary machinery will help in reducing the burden on medical practitioners.”  Commenting on the launch Chander Shekhar Sibal, Senior Vice President, Fujifilm India said, “With our new FDR nano, patients will benefit from imaging, and the radiology services in hospitals and doctors will also experience a corresponding reduction in workload.”     ]]> https://biospectrumindia.com/news/97/18179/spicehealth-signs-mou-with-uttarakhand-govt-to-intensify-covid-19-testing.html https://biospectrumindia.com/news/97/18179/spicehealth-signs-mou-with-uttarakhand-govt-to-intensify-covid-19-testing.html Fri, 26 Feb 2021 19:10:00 +0530 SpiceHealth has signed a memorandum of understanding (MoU) with the Government of Uttarakhand to conduct real-time polymerase chain reaction (RT-PCR) and rapid antigen tests for pilgrims visiting the state for the Kumbh Mela festival. SpiceHealth’s mobile lab, accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) and Indian Council of Medical Research (ICMR), has been set-up in Haridwar. In addition to the mobile lab, SpiceHealth has also set up testing facilities at five locations on the state border where pilgrims visiting Uttarakhand for Kumbh will undergo rapid antigen tests. The testing facilities will be functional from February 26, 2021. Avani Singh, CEO, SpiceHealth said, “Ensuring the safety of the attendees of the mela is of utmost importance, and we at SpiceHealth are proud to assist the Uttarakhand Government in testing and serving those travelling to the holy city of Haridwar.” In view of the current pandemic, authorities at the Kumbh Mela have introduced strict guidelines and made passes mandatory for all pilgrims. Passes will be issued only after the submission of a negative RT-PCR test report, medical certificate and identification proof. ]]> https://biospectrumindia.com/news/97/18171/aster-labs-launches-qr-codes-for-covid-19-reports-for-dubai.html https://biospectrumindia.com/news/97/18171/aster-labs-launches-qr-codes-for-covid-19-reports-for-dubai.html Thu, 25 Feb 2021 14:45:00 +0530 Aster Labs, the diagnostics arm of Aster DM Healthcare, a leading healthcare service provider in the country, has announced the launch of QR codes in all its COVID-19 reports to aid authorities in scanning and verifying the reports online. This announcement has been made keeping in line with the new guidelines released by Dubai’s Health Authority that mandates travellers entering Dubai to have QR codes on their COVID-19 reports. This will further help the authorities in efficient COVID-19 testing and reporting. Along with QR codes, the reports provided by Aster labs will also share information on the date, time of sample collection, sample reporting and will enable access to the original test report stored in the company’s secure LIMS server. KR Jayaprakash, Chief Operating Officer, Aster Labs, said: “We are happy to comply with the new QR code guidelines released by Dubai’s Health Authority. These guidelines will not only promote quality testing and reporting of Covid results but will also ensure the authenticity of the report of the passengers travelling from Bengaluru to Dubai. All the passengers travelling via Bengaluru will be able to take these tests and will be provided with QR-coded test reports. With our digitally enabled workflow, we have been able to meet these new guidelines with zero downtime and are ready to provide all the necessary assistance to the customers travelling to Dubai.” ]]> https://biospectrumindia.com/news/97/18167/medtronic-helps-reduce-infections-associated-with-cardiac-implants.html https://biospectrumindia.com/news/97/18167/medtronic-helps-reduce-infections-associated-with-cardiac-implants.html Thu, 25 Feb 2021 00:00:00 +0530 India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc has announced the launch of the TYRX™ Absorbable Antibacterial Envelope (TYRX Envelope) - an absorbable, single-use, antibacterial envelope designed to stabilise a cardiac implantable electronic device (CIED) or implanted neurostimulator while releasing antimicrobial agents over a minimum of seven days. Constructed from a multifilament, knitted absorbable mesh, the TYRX Envelope holds the CIED device and is fully absorbed by the body approximately nine weeks after implantation. It can be used with any implantable defibrillator, pacemaker, or neurostimulator. “We strive to offer products and services of the highest quality that deliver clinical and economic value to patients and physicians. TYRX is one such value-based offering aimed at lowering infection risk and reducing readmission rates with the long-term goal of creating better outcomes,” said Abhishek Bhargava, Director, Cardiac Rhythm Management, Cardiac Ablation & Diagnostics, Medtronic India.  Results from the landmark Worldwide Randomised Antibiotic Envelope Infection Prevention Trial (WRAP-IT) demonstrated the TYRX Envelope reduced the risk of major infection by 40 per cent in patients with CIEDs, and reduced pocket infections by 61 per cent, when used as an adjunctive therapy in addition to standard-of-care infection prevention strategies for patients at higher risk of infection. The study enrolled approximately 7,000 patients, from 181 centres in 25 countries in Asia, Europe, North America, and South America. The study population included patients receiving an initial cardiac resynchronisation therapy defibrillator (CRT-D); and patients receiving a replacement, system revision or generator upgrade of an existing pacemaker, cardiac resynchronisation therapy-pacemaker (CRT-P), implantable cardioverter defibrillator (ICD) or CRT-D. The TYRX Envelope was cleared by the FDA in 2013 and received CE Mark in 2014.   ]]> https://biospectrumindia.com/news/97/18143/veeda-somru-bioscience-jointly-set-up-bioanalytical-lab-in-ahmedabad.html https://biospectrumindia.com/news/97/18143/veeda-somru-bioscience-jointly-set-up-bioanalytical-lab-in-ahmedabad.html Mon, 22 Feb 2021 11:40:00 +0530 Ingenuity BioSciences Pvt Ltd – Veeda Clinical Research, one of India’s leading and largest independent CRO companies, and Somru BioScience Inc, a leading Canadian-based biotechnology company based in Charlottetown, Prince Edward Island, have announced the establishment of an innovation-centric bioanalytical laboratory in Ahmedabad, India. Veeda and Somru announced the launch of their premier global centre of excellence lab under the flagship of Ingenuity BioSciences Pvt Ltd. This collaborative joint venture aims to capture the growing market needs of the global biosimilars market projected to grow from $28 billion in 2020 to $103 billion in 2026, with a CAGR of 24.2 per cent. Somru BioScience and Veeda Clinical Research will have an equal partnership in the new joint venture. “The joint venture will bring Somru’s global standard, integrated bioassay capabilities to service the rapidly growing biosimilars industry in the region and, combined with Veeda’s strong clinical research credentials, will provide complete clinical development solutions to our clients," said Ajay Tandon, Managing Director, Veeda Clinical Research. Ingenuity BioSciences will be established as a premier and agile bioanalytical laboratory. Somru BioScience’s proprietary automation platform and cloud based Aegryris™ bioanalytical and productivity software suite will be a potential game-changer in the innovation-based drug discovery industry. “This relationship will allow us to leverage our extensive experience as a biosimilar solution provider in this fast-emerging Asian market,” said Mohammed Moin, CEO, Somru BioScience Inc.  Ingenuity BioSciences will be led by Mohammed Moin and Dr Ravi Krovidi, CEO, Ingenuity BioSciences Pvt Ltd. “The biosimilarisation wave is gaining significant traction, with several important monoclonal antibodies going off patent. We are very excited to partner with Somru team,” said Dr Krovidi. ]]> https://biospectrumindia.com/news/97/18124/find-india-health-fund-to-support-testing-efforts-for-covid-19-tb-in-mumbai-.html https://biospectrumindia.com/news/97/18124/find-india-health-fund-to-support-testing-efforts-for-covid-19-tb-in-mumbai-.html Thu, 18 Feb 2021 00:00:00 +0530 The Foundation for Innovative New Diagnostics (FIND) and the India Health Fund (IHF), a Tata Trusts initiative, announced that they are deploying five Truenat™ machines – an innovative, multi-disease diagnostic platform developed by Goa-based Molbio Diagnostics – at select MCGM-run hospitals in Mumbai, to support testing efforts led by the Municipal Corporation of Greater Mumbai (MCGM) for, both, COVID-19 and tuberculosis (TB). Truenat is a chip-based, molecular diagnostic platform, developed in India in collaboration with FIND and with support from IHF, among others. It delivers test results in under 60 minutes. It uses reverse transcription polymerase chain reaction (RT-PCR) to test for multiple diseases including TB, and the Indian Council of Medical Research (ICMR) validated an assay for COVID-19 before the end of May 2020. Each of the select MCGM sites are now being equipped with the Truenat platform, requisite laboratory staff, test cartridges and consumables. The testing facilities will be in the same premises or in close vicinity of the rapid antigen testing site(s), which will minimise sample collection and transportation challenges, reduce waiting times for patients, and limit the chances to spread COVID-19.  Madhav Joshi, CEO, India Health Fund, said, “Innovations are enabling the strengthening of the healthcare response and to that effect we are supplementing the MCGM’s sustained efforts in the screening, diagnosis of TB and Covid-19.” Sanjay Sarin, Head, FIND India, said, “This collaboration with IHF and MCGM will save lives by enabling timely testing and streamlining patient processes, which will help limit the spread of disease.”   ]]> https://biospectrumindia.com/news/97/18122/apollo-anatomiz3d-to-establish-hospital-3d-printing-labs-in-india-.html https://biospectrumindia.com/news/97/18122/apollo-anatomiz3d-to-establish-hospital-3d-printing-labs-in-india-.html Wed, 17 Feb 2021 17:25:00 +0530 The Apollo Hospitals Group and Anatomiz3D Medtech Pvt Ltd have announced a collaboration for the design and printing of complex implants. Apollo Hospitals and Anatomiz3D would take the lead in a pioneering initiative to establish Hospital 3D-printing labs in India for 3D-printed implants that would enable doctors to visualise and print implants for complicated cases. The first of these would be launched at Apollo Health City, Jubilee Hills, Hyderabad. Dr Prathap C Reddy, Chairman, Apollo Hospitals Group said, “3D-printing technology is transforming the medical environment providing a fast, accurate and economical solution to take medical care to the next level! As healthcare evolves, 3D-printing will play an important part of this future transformation.” The Hospital's 3D-printing labs would provide medical 3D printing services for better healthcare, through the creation of anatomical models for pre-surgical planning and education, patient-specific cutting and drilling guides, and customised implants and implant moulds. Sangita Reddy, Joint Managing Director, Apollo Hospitals Group said, “3D-printing has many applications in healthcare and the in-house 3D-printing labs at the hospitals will enable better patient care and treatment planning. This is just the beginning and as the technology continues to develop, we will see the unlocking of the full potential of 3D-printing in healthcare.” Firoza Kothari, Co-founder, CTO, Anatomiz3D said, “Our strategic collaboration with Apollo Hospitals, a progressive organisation and one of the pioneers in adopting new technologies early on that are beneficial to its patients, is a strong step towards such large scale translation. Together, Apollo Hospitals and Anatomiz3D aim to make customised medical devices easily accessible to patients, for an enhanced quality of life.”   ]]> https://biospectrumindia.com/news/97/18110/thermo-fishers-new-bengaluru-facility-to-produce-covid-19-diagnostic-solutions-for-india.html https://biospectrumindia.com/news/97/18110/thermo-fishers-new-bengaluru-facility-to-produce-covid-19-diagnostic-solutions-for-india.html Tue, 16 Feb 2021 17:25:00 +0530 A new state-of-the-art Thermo Fisher Scientific manufacturing facility in Bengaluru will produce COVID-19 testing kits and diagnostic solutions that are made in India for use in India. CoviPath COVID-19 RT-PCR Kit, which contains the assays and controls for Thermo Fisher’s gold standard RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in individuals suspected of COVID-19. The CoviPath COVID-19 RT-PCR Kit has been approved under MDR 2017 rules for in vitro diagnostic use by the Indian Council for Medical Research (ICMR) and Drug Control General of India (DCGI) in all authorised laboratories. Testing with the kit can be done on Applied Biosystems real-time PCR instruments with FAM dye, VIC dye, and JUN dye or any RT-PCR platform with three dye channels in molecular biology laboratories approved for testing. Samples are collected from nasopharyngeal swab, nasopharyngeal aspirate and bronchoalveolar lavage (BAL) specimens. “The new facility is equipped with the capacity to manufacture up to 10 million tests every month. This facility will be instrumental in ensuring access to affordable testing kits while maintaining global quality standards,” said Amit Chopra, Managing Director, India and South Asia, Thermo Fisher Scientific. The CoviPath COVID-19 RT-PCR Kit is designed to detect viral targets with low mutations and offers more than 99.5 per cent sensitivity and 99.5 per cent  specificity. The kit is packaged in a user- friendly and convenient pack size of 200 reactions. “Thermo Fisher’s local production facility will augment accessibility of testing kits across the country.“, said Kapil Sood, Senior Director, Life Sciences Solutions, Thermo Fisher Scientific, India. The Applied Biosystems CoviPath COVID-19 RT-PCR Kit is for use in India only. ]]> https://biospectrumindia.com/news/97/18088/spicehealth-brings-three-mobile-covid-19-testing-labs-in-mumbai.html https://biospectrumindia.com/news/97/18088/spicehealth-brings-three-mobile-covid-19-testing-labs-in-mumbai.html Thu, 11 Feb 2021 17:10:00 +0530 SpiceHealth, in association with the Municipal Corporation of Greater Mumbai (MCGM), has launched three mobile testing laboratories in Mumbai. The mobile labs, which are accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) and Indian Council of Medical Research (ICMR), have been set-up at Bandra Kurla Complex, National Sports Club of India, Worli and NESCO, Goregaon. SpiceHealth’s mobile testing laboratory at Bandra Kurla Complex was inaugurated virtually by Uddhav Thackeray, Chief Minister, Maharashtra, Aditya Thackeray, Tourism and Environment Minister, Maharashtra, in the presence of Ajay Singh, CMD, SpiceJet and Avani Singh, CEO, SpiceHealth and other senior government officials. Avani Singh said, “I am confident that SpiceHealth will help scale up Covid testing in Mumbai and we hope to contribute to the State Government’s efforts in fighting this pandemic.” SpiceHealth, at present, has five mobile labs at government-designated locations in Delhi and Haryana, a testing facility at Manesar in addition to the genome sequencing facility at the Delhi airport. The company is conducting around 20, 000 RT-PCR tests per day. ]]> https://biospectrumindia.com/news/97/18081/orthos-sars-cov-2-antigen-test-now-available-in-india.html https://biospectrumindia.com/news/97/18081/orthos-sars-cov-2-antigen-test-now-available-in-india.html Wed, 10 Feb 2021 18:00:00 +0530 Ortho Clinical Diagnostics now offers the VITROS® SARS-CoV-2 antigen test on their VITROS® 3600, VITROS® 5600/ VITROS® XT7600 systems, designed to detect active infection, can be a vital additional supplement to current testing scenarios. With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour and immediately help hospitals and reference labs address testing backlogs, supply shortages, and delayed results. Thus, providing fast and accurate results. Ortho’s COVID-19 antigen test was the first high-volume test to receive Food and Drug Administration (FDA) emergency use authorisation (EUA) in the US. In India, CDSCO also has given approval for emergency use. “Even as vaccine inoculation programmes roll out, mass-scale testing remains an essential tool in fighting COVID-19. Ortho’s accurate, high-volume COVID-19 antigen test can play a pivotal role in the global response to this virus,” said Chris Smith, Chairman & CEO, Ortho Clinical Diagnostics. ]]> https://biospectrumindia.com/news/97/18070/siemens-healthineers-drives-cardiovascular-interventions-with-robotic-assistance-in-india.html https://biospectrumindia.com/news/97/18070/siemens-healthineers-drives-cardiovascular-interventions-with-robotic-assistance-in-india.html Tue, 09 Feb 2021 14:35:00 +0530 Siemens Healthineers has now added in its portfolio Corindus CorPath GRX, the only FDA cleared and CE certified robotic system, for coronary and peripheral vascular interventions in India. With state-of-art technology, the company has opened a new field for advanced therapies business, tapping into adjacent growth markets with great potential for the future. The robotic cardiovascular interventions can aid significantly in this case, by contributing to cardiovascular medical conditions like heart diseases, where the ideal treatment include complex procedures in the coronary arteries by specialised medical professionals. The smart procedural automation can enable performing complex interventional cases in shorter time, with precision, and with better clinical outcomes. Adoption of robotics in surgical intervention will provide an enormous impetus to the Indian healthcare sector. Possibilities of remote treatment in the near future (currently under approval) could address the key geographical challenges of limited availability of specialists and corresponding clinical facilities for minimally invasive procedures in many regions.  With Corindus technology, Siemens Healthineers is well-positioned to be the leading player in the field of robotic vascular interventions. “The interplay of protection, precision and standardisation through robotic-assisted interventions will allow the cardiologists to perform complex procedures faster and better.  This will allow specialists to improve procedural quality and expand precision medicine; thereby improving clinical outcomes for the patient,” said Sanjay David, Head, Advanced Therapies, Siemens Healthineers, India. ]]> https://biospectrumindia.com/news/97/18048/fujifilm-dr-kuttys-healthcare-launch-novel-screening-centre-in-bengaluru.html https://biospectrumindia.com/news/97/18048/fujifilm-dr-kuttys-healthcare-launch-novel-screening-centre-in-bengaluru.html Thu, 04 Feb 2021 16:35:00 +0530 Fujifilm in collaboration with Dr Kutty's Healthcare, an institution with deep roots in healthcare space, announced the launch of ‘NURA’ – their first health-screening centre in the country, in Bengaluru. The centre is built on three elements - trust, automation between doctors & machines - for reducing time and delivering quality and introducing the culture of screening. Equipped with the best of artificial intelligence (AI) enabled imaging and expert healthcare, NURA centre can correctly test 10 common cancers, including oral cancer, breast cancer, cervical cancer, lung cancer, stomach cancer, colon cancer, prostate cancer, oesophageal cancer, laryngeal cancer and early signs of leukaemia along with other lifestyle diseases. Bringing together Fujifilm’s cutting-edge technology and Dr Kutty’s healthcare expertise, NURA is a step forward towards inculcating a culture of early screening and securing the lives of people while providing and accessible and high-quality healthcare expertise. Masaharu Morita, Regional Group Manager, All Europe, Middle East and Africa at Fujifilm Corporation - Japan, said, “With NURA, our vision is to introduce the culture of periodic health screening in India, as we believe that early detection and treatment are very important to improve the survival rate of cancer patients.” Dr Mohamed Kasim President, Dr Kutty’s Healthcare (DKH), said, “With the launch of this examination centre, we aim to create awareness and an environment of opting for regular medical screening and taking preemptive healthcare measures.” In addition to 10 cancer tests, the centre will provide total medical examination services such as early detection of risks of metabolic syndrome and locomotive syndrome, for the examination of lifestyle-related diseases such as chronic obstructive pulmonary disease and myocardial infarction. ]]> https://biospectrumindia.com/news/97/18025/roche-obtains-ce-mark-for-sars-cov-2-rapid-antigen-test-nasal.html https://biospectrumindia.com/news/97/18025/roche-obtains-ce-mark-for-sars-cov-2-rapid-antigen-test-nasal.html Tue, 02 Feb 2021 12:20:00 +0530 Roche has announced that it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test will be available in countries accepting the CE mark by mid-February, 2021. In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure. This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities. Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements. “Rapid testing continues to play an important role in the fight against COVID-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools.” said Thomas Schinecker, CEO, Roche Diagnostics. “The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with a more comfortable testing experience.” The launch is a partnership with SD Biosensor Inc, with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September 2020. SD Biosensor, is currently preparing to submit an Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA).   ]]> https://biospectrumindia.com/news/97/18024/philips-introduces-portable-kit-to-remotely-monitor-larger-patient-populations-.html https://biospectrumindia.com/news/97/18024/philips-introduces-portable-kit-to-remotely-monitor-larger-patient-populations-.html Tue, 02 Feb 2021 11:45:00 +0530 Royal Philips, a global leader in health technology, has introduced the Philips Medical Tablet, an end-to-end, easy-to-implement, portable monitoring kit designed to help clinicians remotely monitor larger patient populations during emergency situations, like the COVID-19 pandemic. The Medical Tablet integrates with Philips advanced IntelliVue XDS software to enable remote access of patient monitoring information, allowing clinicians to care for patients outside of the hospital setting. This solution is not tied to a central monitoring station and can therefore be operated through WiFi connection, making it easy to deploy and integrate into existing clinical structures and workflows. The Philips Medical Tablet using XDS software can connect to multiple IntelliVue monitors in the same network, allowing clinicians to remotely monitor multiple patients to reduce contact as well as lessen bedside monitoring disturbances and interruptions. Peter Ziese, General Manager, Monitoring Analytics, Philips said, “The Philips Medical Tablet with IntelliVue XDS software gives clinicians critical patient data like vital signs and clinical decision support applications right at their fingertips, empowering them to make informed care decisions no matter where they are.” Outside of emergency-use situations, the Philips Medical Tablet with IntelliVue XDS software can be used as an extended screen, working as a companion to the IntelliVue monitor to display meaningful patient information through clinical decision support tools. It can also act as a clinical workspace, combining patient monitoring views and the hospital’s IT applications, allowing clinicians to simultaneously interact across multiple systems for enhanced patient care. The Philips Medical Tablet, integrated with the IntelliVue XDS software joins a growing portfolio of solutions aimed at addressing the challenges and changes in patient care brought upon by COVID-19.   ]]> https://biospectrumindia.com/news/97/18017/who-releases-essential-diagnostics-list-for-2021.html https://biospectrumindia.com/news/97/18017/who-releases-essential-diagnostics-list-for-2021.html Mon, 01 Feb 2021 00:00:00 +0530 To address the lack of access to tests and testing services in multiple countries, WHO since 2018 has published a yearly essential diagnostics list (EDL), a basket of recommended in vitro diagnostics that should be available at point-of-care and in laboratories in all countries to increase timely and life-saving diagnoses. The latest edition, published, includes WHO-recommended COVID-19 tests (PCR and Antigen), expands the suite of tests for vaccine-preventable and infectious diseases and non-communicable diseases (such as cancer and diabetes), and introduces a section on endocrinology, which is important for reproductive and women’s health.  Dr Tedros Adhanom Ghebreyesus, Director-General, WHO said, ‘All countries should pay particular attention to the diagnostics space and use the essential list to promote better health, keep their populations safe, and serve the vulnerable.’ Dr Mariângela Simão, Assistant-Director General, Access to Medicines and Health Products WHO, said, “In all countries, the use of appropriate diagnostic tests can help inform evidence-based treatment and responsible use of medicines, resulting in improved allocation of resources and better health outcomes.” The recommendations in the list are based on robust evidence and take into account country suitability. The process is overseen by the Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD), a group of specialists from around the world with long standing experience in the field of IVDs and their implementation, their use, regulation and evaluation.  The EDL is not prescriptive – it is intended as a policy tool for countries to create their own national lists based on their local context and needs. WHO will shortly also publish a step-by-step guide to aid countries wishing to develop a national list. ]]> https://biospectrumindia.com/news/97/18018/philips-offers-new-solution-for-detecting-abdominal-aortic-aneurysms.html https://biospectrumindia.com/news/97/18018/philips-offers-new-solution-for-detecting-abdominal-aortic-aneurysms.html Fri, 29 Jan 2021 00:00:00 +0530 Royal Philips, a global leader in health technology, has introduced the Philips Abdominal Aortic Aneurysm (AAA) Model, providing physicians a more patient-friendly solution compared to the current standard of care for managing AAA patients. Based on 3D ultrasound, Philips AAA Model delivers clinicians accurate diagnostic information without exposing patients to high doses of radiation and nephrotoxic contrast agents.An abdominal aortic aneurysm (AAA) is an aneurysm that forms in the lower part of the aorta. Typically, AAAs are identified incidentally during abdominal imaging exams but, in some cases, remain undetected until rupture. A ruptured AAA has an 80% mortality rate, emphasizing the importance of routine surveillance. Philips AAA Model integrates innovative software and leading Philips 3D ultrasound technologies into a single solution to help increase diagnostic confidence and an improved patient experience. The software automatically segments and quantifies the size of the aneurysm sac for surveillance of known native (untreated), and post-EVAR (treated) AAAs. The current standard of care for AAAs includes 2D ultrasound and computed tomography angiography (CTA). Each of these modalities has its drawbacks, including inter-operator variability with 2D ultrasound and patient exposure to high levels of radiation and nephrotoxic contrast agents with CTA. ]]> https://biospectrumindia.com/news/97/18010/sai-life-sciences-plans-to-double-headcount-enhance-capabilities-in-uk.html https://biospectrumindia.com/news/97/18010/sai-life-sciences-plans-to-double-headcount-enhance-capabilities-in-uk.html Thu, 28 Jan 2021 19:00:00 +0530 Hyderabad based Sai Life Sciences, one of India's fastest growing Contract Research, Development & Manufacturing Organisations (CRDMOs), has announced plans to double its headcount and expand its suite of technical capabilities at its Manchester site, a centre of excellence for API process and analytical development serving an expanding list of global clients. Making the announcement, Krishna Kanumuri, CEO & Managing Director, Sai Life Sciences, said, "We are truly heartened by our customers' response to our Manchester site. The site serves as a vital bridge to our pilot and manufacturing facilities in India, enabling seamless integration with the rest of our service offerings across the US and India, spanning the drug discovery, development, and commercialisation continuum. This expansion will further enhance our ability to add value to the NCE pipelines of our customers.” The Sai Life Sciences' Manchester site became fully operational in August 2020, onboarded 24 members of staff and has since delivered multiple projects involving complex chemistry. With a growing interest from customers across the UK, Europe and the US, the present expansion involves an increase in capacity from 20 to 75 fume cupboards and an increase in headcount from 24 to 50+ scientists. Located in the heart of the Alderley Park life-sciences ecosystem, Sai Life Sciences' Manchester site creates opportunities for the UK and EU based pharma companies and biotechs to have easier face-to-face collaboration with its scientists, and to provide easier collaboration with US-based clients due to reduced time zone differences.  Sai Life Sciences is currently amid an organisation-wide transformation. It is investing $150 million during 2019-23, as part of the Sai Nxt initiative, across three core areas – people & culture, processes & automation, infrastructure & scientific capabilities. ]]> https://biospectrumindia.com/news/97/17981/roche-diagnostics-launches-elecsys-anti-sars-cov-2s-test-in-india.html https://biospectrumindia.com/news/97/17981/roche-diagnostics-launches-elecsys-anti-sars-cov-2s-test-in-india.html Fri, 22 Jan 2021 16:20:00 +0530 Roche Diagnostics India has announced the launch of its antibody test SARS-CoV-2 test-Elecsys Anti-SARS-CoV-2 S. The test is CE IVD approved and has received ICMR and CDSCO approval in India. It is an in vitro test, that quantifies antibodies against the receptor-binding domain (RBD) of spike (S) protein SARS-CoV-2 in human serum and plasma, and determines the body’s immune response to the virus. The Elecsys Anti-SARS-CoV-2 S targets antibodies, which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. Narendra Varde, Managing Director, Roche Diagnostics India, said, “The newest antibody solution, Elecsys Anti-SARS-CoV-2 S, will not only give a ‘positive’ or ‘negative’ result, but also will provide a numerical result to indicate the concentration of SARS-CoV-2 specific antibodies in the blood, further supporting the healthcare systems and patients as we jointly fight COVID-19.” Dr Sandeep Sewlikar, Head of Medical & Scientific Affairs, Roche Diagnostics India, pointed out the need for an antibody test for India by stating: “The test has both a high clinical specificity of 99.98% (N=5991) and sensitivity of 98.8% (N=1423), 14 days or later after diagnosis with PCR. The result is provided in the form of an antibody concentration (U/mL).  The Elecsys Anti-SARS-CoV-2 S immunoassay runs on Roche’s widely available cobas e analysers, and these fully automated systems can provide SARS-Cov-2 test results in approximately 18 minutes for one test, with a test throughput of up to 300 tests/hour, depending on the analyser. ]]> https://biospectrumindia.com/news/97/17973/barco-unveils-nio-fusion-12mp-for-future-ready-diagnostic-imaging-in-india.html https://biospectrumindia.com/news/97/17973/barco-unveils-nio-fusion-12mp-for-future-ready-diagnostic-imaging-in-india.html Thu, 21 Jan 2021 16:10:00 +0530 Barco, a global leader in visualisation technology, has released a new 12MP healthcare diagnostic display system for picture archiving and communication systems (PACS) and breast imaging.  The Nio Fusion has a 12MP screen resolution, which makes it suitable for multiple PACS images and breast imaging modalities including breast tomosynthesis. A Keyboard-Video-Mouse (KVM) function makes it possible to attach a second workstation to the display and switch between two computers at the touch of a button, simplifying scheduling and the management of the workstation fleet. Rachel Coxon, Vice President Healthcare, Barco APAC said, “The Nio Fusion 12MP delivers diagnostic flexibility for both PACS and breast imaging, addressing today's radiology and mammography landscape at cost-effective pricing.”  The Nio Fusion 12MP is calibrated to meet the Digital Imaging and Communications in Medicine (DICOM) standard for grey-scales, and Barco’s SteadyColorTM technology guarantees consistent, calibrated colours over time. The luminance of the Nio Fusion 12MP is well above industry standard, which is further enhanced by Uniform Luminance Technology to make sure that all areas of the screen maintain the same brightness. Rajiv Bhalla, Managing Director, Barco India said, “Heavy workload & ergonomic stress levels coupled with the increasing complexity of cases, requires high resolution, accurate, calibrated colours and image quality to help reveal more details. The Nio Fusion 12MP addresses all these diagnostic workstation challenges effectively and at the same time is cost-effective with documented clinical advantages and a superior warrantied lifetime of up to 40K hours.” Nio Fusion 12MP is driven by a powerful Barco MXRT display controller, offering radiologists a set of workflow support tools, such as SpotViewTM and RapidFrameTM that also greatly increase diagnostic accuracy. ]]> https://biospectrumindia.com/news/97/17963/experts-explore-possibilities-and-future-plans-for-indias-medtech-.html https://biospectrumindia.com/news/97/17963/experts-explore-possibilities-and-future-plans-for-indias-medtech-.html Wed, 20 Jan 2021 00:30:00 +0530 Health committee, PHDCCI in association with Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt of India organised the second series of Self Sufficiency in Medical Technology on ‘Innovation & Incentivisation of Indigenous MedTech Manufacturing’ on January 15 2021. The Guest of Honour of the session was Dr S Eswara Reddy, Joint Drugs Controller General of India, CDSCO, complemented the MedTech industry for doing an excellent job in the last decade, yet accessibility needs to improve significantly. Dr Reddy said that the government provides many schemes to promote innovation and pooling of the R&D funds which are offered by the various ministries could significantly give an impetus to the medtech ecosystem. The webinar was graced with the presence of Pradeep Multani, Sr Vice President, PHDCCI, Dr N Subramanian, Chair, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals, Dr Sameer Gupta, Co-Chair, Health Committee, PHDCCI & Director, Cardiac Cath Lab, Metro Group of Hospitals and Prof (Dr) Harvinder Popli, Co-Chair, Health Committee, PHDCCI & Director, SPS, Delhi Pharmaceutical Sciences and Research University, Govt of NCT of Delhi. Multani hailed the PLI and Promotion of Medical Devices Parks scheme and said that these initiatives have the potential to contribute significantly to achieving higher objectives of affordable healthcare in the country and globally on a sustained basis. Dr Sharma said that we should not discriminate research by nature of institutions as government or private and we must have national R&D fund which does not discriminate between government and private institutions. Dr Subramanian mentioned that the industry should have the approach to produce minimal invasive and preventive healthcare. Dr Popli talked about standards and compliances in the manufacturing, lack of trained manpower & told to have right framework for the same. The session was moderated by Vivek Seigell, Assistant Secretary General, PHDCCI.  ]]> https://biospectrumindia.com/news/97/17959/ss-innovations-launches-south-asias-first-medical-robotics-surgery-system.html https://biospectrumindia.com/news/97/17959/ss-innovations-launches-south-asias-first-medical-robotics-surgery-system.html Tue, 19 Jan 2021 17:45:00 +0530 Leading with a vision to offer minimally invasive robotic surgery solutions, Dr Sudhir P Srivastava and his team have recently launched SSI MANTRA (Multi-Arm Novel Tele Robotic Assistance) Surgical Robotic System, with a live demonstration, in New Delhi, on January 19, 2021. The event marked the presence of national media at the launch alongside attendance from dignitaries like Amitabh Kant, CEO Niti Ayog via web-conferencing. “Robotics shall be the future of surgery, and my vision is to create a technologically advanced system that will be cost-effective, easy to use, and can be applied to all surgical specialties. Thus, benefitting most patients around the world. Compared to conventional surgery, robotic surgery results in smaller incisions, that reduces pain, scarring and leads to quicker recovery,” said Dr Srivastava, one of the early pioneers in minimally invasive and robotic cardiac surgery. He has performed over 1,400 robotic cardiac surgical procedures in the expanse of his career as a surgeon. It is his goal to build an affordable surgical robotic system that is easier for surgeons to use and provides easier access for patients around the world. The MANTRA system was recently utilized for the first human pilot study at Rajiv Gandhi Cancer Institute, where the surgeons successfully completed 18 complex Urology, Gynaecology, and General Surgery procedures in less than a month.  The SSI Mantra surgical robotic system can be utilized for all major surgical specialties including Urology, General Surgery, Gynaecology, Thoracic, Cardiac, and Head & Neck Surgery.  The SSI Mantra System shall additionally have automated enabling technologies for coronary bypass and valve operations. ]]> https://biospectrumindia.com/news/97/17956/neuberg-diagnostics-receives-icmr-nod-to-conduct-nationwide-covid-19-tests.html https://biospectrumindia.com/news/97/17956/neuberg-diagnostics-receives-icmr-nod-to-conduct-nationwide-covid-19-tests.html Mon, 18 Jan 2021 18:50:00 +0530 Neuberg Diagnostics, India’s fourth largest diagnostics lab chain, has received approval from the Indian Council of Medical Research (ICMR) for conducting COVID-19 tests in Noida, UP (Delhi NCR), Visakhapatnam, Andhra Pradesh; Salem, Tamil Nadu and Kozhikode, Kerala. All these labs have the capacity to process close to 7000 RT-PCR (Reverse Transcription Polymerase Chain Reaction) test samples every day. Besides these cities, as per ICMR guidelines, Neuberg has been conducting tests in its 10 labs in cities consisting - Chennai, Trichy, Kochi, Hyderabad, Bengaluru, Pune, Ahmedabad, Surat, Indore & Udaipur. In tandem with airport authorities, Neuberg has also setup RT-PCR test counters at Ahmedabad and soon going to set up counters in Lucknow and Mangalore airports. The test will be available for all international arrivals as well as to domestic travellers arriving and departing from the airport. The hard copy of the test result will be given within 6-8 hours to all the passengers undergoing COVID-19 test. Aishwarya Vasudevan, Group Chief Operating Officer, Neuberg Diagnostics said, “As part of its corporate social responsibility, in this hour of a national public health emergency, we have been conducting free-of-cost as well as subsidised tests for deserving patients in all cities.” Apart from this Neuberg also has presence in South Africa with three approved Covid molecular testing labs in Durban, Johannesburg, and Cape Town.     ]]> https://biospectrumindia.com/news/97/17951/india-brings-first-indigenous-flow-diverter-stent.html https://biospectrumindia.com/news/97/17951/india-brings-first-indigenous-flow-diverter-stent.html Mon, 18 Jan 2021 13:25:00 +0530 Indians will soon have access to the country’s first indigenous flow diverter stent for diverting blood flow away from localised ballooning of arteries in the brain and a device that promotes better healing of the hole in the heart. In order to address the challenges, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an autonomous institute of the Department of Science & Technology (DST), Govt of India, under the Technical Research Centre (TRC), has entered into Technology Transfer Agreements with Pune-based Biorad Medisys for two biomedical implant devices--- an Atrial Septal Defect Occluder and an Intracranial Flow Diverter Stents developed by the institute in collaboration with National Aerospace Laboratories, Bangalore (CSIR-NAL) using superelastic NiTiNOL alloys. The Technology Transfer Agreements agreements were signed by Dr K Jayakumar, Director, SCTIMST, and Jitendra Hedge, Managing Director, Biorad Medisys, in the presence of Dr Jitendra J Jadhav, Director, CSIR- NAL, through an online meeting last week. The novel ASD occlude developed by SCTIMST promotes better healing of the hole in the heart and also has softer edge for minimising the damage to adjacent tissue. The delivery system has a novel release mechanism to enable smooth release of the device. The device is protected through two Indian patent applications, one international patent application, and design registration. The device is also provided with radio-opaque markers for radiographic visibility. The associated delivery system allows accurate positioning of the device across the aneurysm. These features have been protected through two Indian patent applications, one international patent application, and design registration. The cost of the Chitra Flow Diverter stent is expected to be priced significantly lower than the currently imported ones. ]]> https://biospectrumindia.com/news/97/17937/csir-igib-spicehealth-intensifies-screening-for-new-mutant-strains-of-covid-19.html https://biospectrumindia.com/news/97/17937/csir-igib-spicehealth-intensifies-screening-for-new-mutant-strains-of-covid-19.html Thu, 14 Jan 2021 16:45:00 +0530 In a move that would ensure early action in containing new mutant variants of COVID-19 detected in the UK and other countries, SpiceHealth has tied-up with CSIR-Institute of Genomics and Integrative Biology (CSIR-IGIB) to set up a portable testing laboratory for genome sequencing at Delhi’s Indira Gandhi International airport for all positive samples from international travellers. Under this programme, all positive samples from international travellers arriving at Delhi’s IGI airport would be sequenced at the airport sequencing laboratory, to ensure early action in containing new mutant variants that have increased transmissibility. CSIR’s experience using portable sequencers suggests that it is possible to identify variants within 48 hours of a person arriving in India and testing positive. Sequencing at the airport could thus save as much as five days of potential transmission, reducing the spread of the imported variant strains. Avani Singh, CEO, SpiceHealth, said, “The new mutant strains of Coronavirus need immediate and effective attention. Our collaboration with CSIR-IGIB is a significant step towards early detection of new mutant variants.” Dr Shekhar C Mande, DG, CSIR, said, “I compliment SpiceHealth for being instrumental in introducing the dry swab direct RT-PCR testing developed by CSIR-CCMB, at SpiceHeath’s mobile labs.” Dr Anurag Agrawal, Director, CSIR-IGIB, said, “We plan to use it to help in better monitoring and managing the SARS CoV2 pandemic, but this is just a beginning towards its many potential clinical and public health applications.” In its bid to offer strong resistance against COVID-19, the Company tied up with CSIR-CCMB for conducting the game changing dry swab RT-PCR tests at SpiceHealth’s mobile testing laboratories. ]]> https://biospectrumindia.com/news/97/17930/ncbs-dbt-instem-develop-inexpensive-testing-method-for-covid-19.html https://biospectrumindia.com/news/97/17930/ncbs-dbt-instem-develop-inexpensive-testing-method-for-covid-19.html Wed, 13 Jan 2021 12:40:00 +0530 Efficient detection of the virus that causes COVID-19 has been a question on the minds of many researchers worldwide since early 2020. NCBS researcher Dr Arati Ramesh, along with Dr Akash Gulyani from the University of Hyderabad, sought to tackle the pressing need for a rapid, accurate, and inexpensive testing method. A team of students from NCBS and DBT-inStem joined their efforts to create PHANTOM (PHAsed NASBA-Translation Optical Method). PHANTOM provides a direct and ultrasensitive test that is both a powerful and an easily accessible strategy to detect a COVID-19 infection.  This diagnostic tool was developed using RNA biosensors to detect SARS-CoV-2 RNA, based on ‘toehold switches’, sensors which can be designed to detect any sequence of interest. The target RNA, in this case, a portion of the SARS-CoV-2 RNA, binds to the sensor and activates it. This activation then triggers production of a reporter protein that causes a change in colour (lacZ) or luminescence (Nano-lantern). “This ease of detection was one of the big motivations behind developing this assay,” says Dr Ramesh.  “The power of the test is that it is sensitive and specific but there is no need for sophisticated equipment or trained personnel to interpret the results unlike the RT-PCR test which is considered the gold standard for SARS-CoV-2 detection,” says Dr Gulyani. Prof Satyajit Mayor, Centre Director, NCBS says, “Given its use as a platform technology that can be used in a resource-poor environment, it has attracted great interest from a number of organisations at the very start of the pandemic: CSR funds from PNB Housing, IQVIA, and a generous grant from APPI have supported this effort that we deemed a priority.”   ]]> https://biospectrumindia.com/news/97/17923/bosch-develops-non-invasive-portable-haemoglobin-monitor-.html https://biospectrumindia.com/news/97/17923/bosch-develops-non-invasive-portable-haemoglobin-monitor-.html Mon, 11 Jan 2021 18:20:00 +0530 Bosch has developed a portable haemoglobin monitor solution (HMS) especially for regions where routine access to medical care tends to be difficult. This HMS allows a large number of people to be screened for anaemia rapidly, safely, using a non-invasive approach. The solution has been named a CES Innovation Award Honouree in the ‘Health and Wellness’ category. “This should offer people better diagnosis options even in resource constrained conditions. The use of artificial intelligence is revolutionising anaemia management, specifically in point-of-care setups and closer to the patient”, explains Dattatri Salagame, President and Managing Director, Robert Bosch Engineering and Business Solutions Private Limited (RBEI). The intelligent solution by Bosch is designed for use directly at the point-of-care and is completely pain-free with no need for a blood test, as the value is determined by a finger scanner using multi-wavelength spectrophotometry on the surface of the skin. The system uses an optical sensor to precisely and reliably measure the photoplethysmogram (PPG) signals. The device provides a reliable result within 30 seconds even for low haemoglobin concentrations.  A laboratory analysis is not necessary and there is no risk of infection from contaminated needles. Participants receive their test results quickly at the point of care. The device is battery operated, does not need subsequent calibration, and is extremely easy to use. It is intended for use in outlying and remote regions by healthcare professionals. Location-based reporting ensures easy clinical traceability. Market release in India is expected by mid-2021. ]]> https://biospectrumindia.com/news/97/17895/regulator-approves-indigenous-non-invasive-ventilator-for-covid-19-patients.html https://biospectrumindia.com/news/97/17895/regulator-approves-indigenous-non-invasive-ventilator-for-covid-19-patients.html Wed, 06 Jan 2021 14:50:00 +0530 CSIR-NAL (National Aerospace Laboratories) scientists, along with medical professionals from CSIR-IGIB (Institute of Genomics and Integrative Biology) came forward to address the shortages of ventilators in the beginning of the COVID-19 pandemic and indigenously designed and developed the non-invasive bilevel positive airway pressure ventilator–SwasthVayu, with additional features to treat COVID-19 patients. The performance of the device has been evaluated by the expert committee constituted by Director General of Health Services, Ministry of Health & Family Welfare, Government of India. The expert committee, after careful evaluation, has concluded that SwasthVayu may be used on COVID-19 patients who require oxygen supplementation up to 35 per cent.  SwasthVayu developed by CSIR-NAL is a microcontroller based precise closed-loop adaptive control system with a built-in biocompatible ‘3D printed manifold and coupler’ with HEPA filter (Highly Efficient Particulate Air Filter).  These unique features help to alleviate the fear of the virus spread. It has features like CPAP, Bi-Timed, Spontaneous / AUTO modes with provision to connect oxygen concentrator or enrichment unit externally. The ventilator has gone through stringent tests for electrical safety, performance and bio-compatibility at NABL accredited agency. The SwasthVayu has successfully conducted clinical trials at Command Hospital, Bengaluru and Mysore Medical College & Research Institute, Mysuru on 50 COVID-19 patients.  CSIR-NAL has commercialised this technology with six private companies and one of these companies (which is in the MSME category) has set up the production facilities for almost 300 units per week. CSIR-NAL recently bagged an order for supply of 1200 SwasthVayu machines to Delhi Government. ]]> https://biospectrumindia.com/news/97/17889/imaginarium-ge-to-accelerate-adoption-of-metal-3d-printing-technology-in-india.html https://biospectrumindia.com/news/97/17889/imaginarium-ge-to-accelerate-adoption-of-metal-3d-printing-technology-in-india.html Tue, 05 Jan 2021 17:35:00 +0530 GE Additive has selected Imaginarium to join its global sales partner network as an official sales partner in India. Imaginarium will resell GE Additive’s portfolio of metal additive manufacturing machines and metal powders which includes Direct Metal Laser Melting (DMLM) and Electron Beam Melting (EBM) technologies. The products are aimed at manufacturers across a wide range of industries, including the aerospace and defence, medical and dental, automotive, tool & die and jewellery. Imaginarium will engage with potential customers to demonstrate the different applications in industry-grade prototyping and production. This will help to educate and build awareness and prospective companies’ confidence to apply in additive manufacturing across their business. GE Additive will leverage Imaginarium’s network in the Indian market to drive adoption of its state-of-the-art metal additive manufacturing machines. Some of the key benefits of metal-based additive manufacturing technology from GE Additive include: ●        Dental: On-demand manufacturing of crowns, bridges ●        Medical: Customised implants and optimised supply chain   Czek Haan Tan, General Manager – Sales & Services APAC, GE Additive said, “Companies across India are starting to make good progress in their adoption of Industry 4.0, and with that comes increased interest in additive technologies, including metal 3D printing.” Kamlesh Parekh, CEO, Imaginarium India Pvt Ltd, said, “Metal additive manufacturing technology has the potential to disrupt the industry by catalysing innovation and enabling the production of indigenous, made-in-India, made-for-the-world products.” ]]> https://biospectrumindia.com/news/97/17242/biospectrum-ranking-issue-for-medtech-diagnostics-coming-soon.html https://biospectrumindia.com/news/97/17242/biospectrum-ranking-issue-for-medtech-diagnostics-coming-soon.html Mon, 04 Jan 2021 00:00:00 +0530 Amidst the pandemic, one more financial year concluded with lots of figures, calculations, positives and negatives, all related to finance and money, telling us where exactly the organisation stands today compared to the previous years. Everybody is interested in knowing the organisation’s performance – independent as well as compared to others in the sector. To highlight the achievements of the medtech/diagnostics sector in India, BioSpectrum is planning the ranking special issue in February 2021. Companies will be ranked on the basis of their revenues and other achievements that took place in the last financial year FY19-20.   The last date for application is 8 January. Click below to fill the form- https://www.biospectrumindia.com/ranking-survey-medtech ]]> https://biospectrumindia.com/news/97/17835/fluidigms-saliva-based-rt-pcr-kit-receives-approval-in-india-.html https://biospectrumindia.com/news/97/17835/fluidigms-saliva-based-rt-pcr-kit-receives-approval-in-india-.html Thu, 24 Dec 2020 17:15:00 +0530 With the increased reliance on saliva based testing, US based Fluidigm has revealed that its Advanta Dx SARS-COV-2 RT-PCR kit, which is a saliva based diagnostic test has been authorized for use in India. This kit facilitates SARS-CoV-2 detection from saliva samples easing the sample collection process & eliminating the need for Viral RNA extraction process. The kit is compatible with Fluidigm’s high-throughput Biomark HD platform. Fluidigm claims that with certain configurations, the Biomark HD system can run a maximum of 6000 samples and controls per day. This FDA-EUA approved kit has also now received DCGI-CDSCO license for use in India by ICMR approved testing labs as per their guidelines. This test kit from Fluidigm is sold and marketed by Premas Lifesciences Pvt Ltd, New Delhi in India. Praveen Gupta, MD, Premas Lifesciences says, “Fluidigm’s much-needed non-invasive saliva-based test comes at a critical time in the pandemic, and we are pleased to be able to facilitate availability of the Advanta assay in India.” In a recent announcement, Chris Linthwaite, President & CEO, Fluidigm said, “We are now in discussions with potential customers, which include private testing labs as well as academic institutions and government medical centres. We are honored for the opportunity to advance the availability of non-invasive saliva-based COVID-19 testing in India at this critical time.” ]]> https://biospectrumindia.com/news/97/17831/experts-emphasize-on-harmonising-international-regulations-for-medical-devices.html https://biospectrumindia.com/news/97/17831/experts-emphasize-on-harmonising-international-regulations-for-medical-devices.html Wed, 23 Dec 2020 17:10:00 +0530 India has come a long way by showing its capabilities & its manufactures have come a long way by showing their capacity, the capability to sustain all the odds & deliver the services. The government support through PLI Schemes has been a boon and that’s what the government wants, deliberated Dr VG Somani, Drugs Controller General of India, CDSCO in Webinar series on Self Sufficiency (Atmanirbhar Bharat) in Medical Technology in Series I Webinar on Development of National Medical Technology Roadmap organised by PHD Chamber of Commerce and Industry (PHDCCI) on December 22, 2020. Dr VG Somani mentioned that there is a need to look at quality, affordability, and access, and service delivery while developing medical products from a pricing and regulatory perspective. We need to keep on monitoring it so that it becomes a reliable solution for the consumer at large. Talking about the regulations, “babysteps to be taken for harmonizing the international regulatory standards for medical devices is the way forward”. We need to consider that it doesn’t disrupt the actual manufacturing, market, and consumer cycle. We should have quality throughout the life cycle of the product as best as possible with the world", he said. Dr Jitender Sharma, MD & CEO, AMTZ said that there is a need to control the import and export HS codes; PLI Scheme for next 3 years; consolidation of R&D funding on medical technologies; free fall of prices for social maximisation and set minimum prices of products for leveraging the business.   Pradeep Multani, Sr Vice President, PHDCCI while giving an industry perspective, talked about the increase in the market size share and domestic players which are operating in the consumables segment and catering to local consumption with limited exports. Rajiv Nath, Forum Coordinator, AiMED stated that Covid exposed India’s soft under belly of excessive import dependence of medical devices & the need for country to go into lockdown to prepare ammunition to fight Covid and build manufacturing & healthcare delivery infrastructure on war footing with close coordinated unprecedented Inter Ministry support. ]]> https://biospectrumindia.com/news/97/17812/philips-acquires-biotelemetry-for-2-8b.html https://biospectrumindia.com/news/97/17812/philips-acquires-biotelemetry-for-2-8b.html Fri, 18 Dec 2020 19:25:00 +0530 Royal Philips and BioTelemetry Inc, a leading US-based provider of remote cardiac diagnostics and monitoring, have announced that they have entered into a definitive merger agreement. Pursuant to the agreement, Philips will commence a tender offer to acquire all of the issued and outstanding shares of BioTelemetry for $72.00 per share, to be paid in cash upon completion. This represents a 16.5 per cent premium to BioTelemetry’s closing price on December 17, 2020. The implied enterprise value is $2.8 billion inclusive of BioTelemetry’s cash and debt. The board of directors of BioTelemetry has approved the transaction and recommends the offer to its shareholders. The transaction is expected to be completed in the first quarter of 2021. The acquisition of BioTelemetry is a strong fit with Philips’ cardiac care portfolio, and its strategy to transform the delivery of care along the health continuum with integrated solutions. The combination of Philips’ leading patient monitoring position in the hospital with BioTelemetry’s leading cardiac diagnostics and monitoring position outside the hospital, will result in a global leader in patient care management solutions for the hospital and the home for cardiac and other patients. Philips’ current portfolio includes real-time patient monitoring, therapeutic devices, tele-health and informatics. Moreover, Philips has an advanced and secure cloud-based Philips HealthSuite digital platform optimised for the delivery of healthcare across care settings. Every year, Philips’ integrated solutions monitor around 300 million patients in hospitals, as well as around 10 million sleep and respiratory care patients in their own homes. Frans van Houten, CEO, Royal Philips said, “ Leveraging our collective expertise, we will be in an optimal position to improve patient care across care settings for multiple diseases and medical conditions.” Joseph H Capper, President, CEO, BioTelemetry said, “Combined with Philips’ current patient care management portfolio, innovation strength and global scale, we are perfectly equipped to address the rising demand for tele-health and remote monitoring solutions.” BioTelemetry primarily focuses on the diagnosis and monitoring of heart rhythm disorders, representing 85% of its sales. BioTelemetry’s clinically validated offering includes wearable heart monitors (eg a mobile cardiac outpatient telemetry patch and extended Holter monitor) that detect and transmit abnormal heart rhythms wirelessly, AI-based data analytics and services.   ]]> https://biospectrumindia.com/news/97/17786/cipla-launches-rapid-antigen-test-kits-for-covid-19.html https://biospectrumindia.com/news/97/17786/cipla-launches-rapid-antigen-test-kits-for-covid-19.html Wed, 16 Dec 2020 13:15:00 +0530 Cipla has announced its partnership with the Premier Medical Corporation Private Limited for commercialisation of the rapid antigen test kits for COVID-19 in India. The company will commence supply from this week. This is Cipla’s second launch in the diagnostics space after Elifast: SARS CoV-2 IgG ELISA Test Kit. In this collaboration, Cipla will be responsible for the marketing and distribution of the Rapid Antigen Detection Test for the qualitative detection of SARS-CoV-2 antigen that will be manufactured by Premier Medical Corporation Private Limited. The test is a rapid point-of-care nasopharyngeal swab test that directly detects the presence or absence of coronavirus antigen in the patient’s body, generating results within 15-20 minutes. Only authorised labs are permitted by ICMR to conduct the rapid antigen testing. The test will be marketed under the brand name ‘CIPtest’. CIPtest is a reliable high-performing kit that has been validated and approved by ICMR. It is found to have specificity and sensitivity of 98.09% and upto 75% respectively. The test is not only rapid with a quick turn-around time, but also enables easy interpretation of results without the need of any additional instrument. Cipla’s expansive distribution network will help in ensuring supply of kits across the country. ]]> https://biospectrumindia.com/news/97/17774/sakra-world-hospital-introduces-worlds-first-active-robotic-knee-replacement-system.html https://biospectrumindia.com/news/97/17774/sakra-world-hospital-introduces-worlds-first-active-robotic-knee-replacement-system.html Tue, 15 Dec 2020 00:00:00 +0530 Sakra World Hospital, based in Bengaluru, now boasts of the country's one of its kind healthcare breakthrough ̶ advanced robotic knee replacement technology that is set to empower the orthopaedic surgeons to plan the knee replacement days before they enter the operation theatre to actually conduct the procedure. CUVIS Joint, the world's first fully active robotic knee replacement system which is now making knee replacement surgeries more accurate, transparent and hassle-free in Sakra World Hospital and comes as a bliss for those suffering from severe arthritis. Manufactured by Curexo, a South Korean firm and marketed and sold by Meril Healthcare in India and known for its unique and autonomous nature of functioning, CUVIS Joint was launched by BS Yediyurappa, Chief Minister, Karnataka and Dr Shivaraj Kumar, popular Kannada film actor. Dr Chandrasekhar P, Senior Consultant & Head – Department of Orthopaedics, Sakra World Hospital with an experience of conducting 5,000 successful knee replacement surgeries and one of the key global opinion leaders behind the development of CUVIS fully active robotic system said, "This robotic software allows three stage planning: pre-operative plan, plan during the procedure and post-operative plan which shows if the surgery has been done as per the plan and whether the same anatomy has been depicted and perfectly performed." Takashi Maki, Managing Director – Sakra World Hospital shared, “With CUVIS Joint, we hope to offer optimum clinical outcome and garner maximum patient satisfaction." The fully active nature of CUVIS Joint helps in conducting joint replacement surgeries in an exceptional manner requiring least human intervention. In addition to the maximum precision, accuracy and flexibility on offer, it has features for maximum safety as well. It takes help of CT-Scan images to develop patient-specific 3D bone models and does the virtual simulation of joint replacement surgeries personalised for each patient. With sub-millimeter dimensional accuracy, it helps to get the optimal post-surgery outcomes for joint replacement. The benefits that this avant-garde robotic technology brings in include lesser tissue trauma and associated blood loss, faster recovery, early hospital discharge and best possible implant positioning with maximum cutting accuracy. Manish Deshmukh, Head of Marketing and Technical at Meril Healthcare Pvt Ltd says, “We, at Meril, are really looking forward to adding this new dimension of technological advancement in the field of joint replacement and achieving newer heights with our impeccable association with Sakra World Hospital and Dr Chandrashekar P.” ]]> https://biospectrumindia.com/news/97/17780/azooka-labs-reveals-first-range-of-novel-covid-19-diagnostics-products.html https://biospectrumindia.com/news/97/17780/azooka-labs-reveals-first-range-of-novel-covid-19-diagnostics-products.html Tue, 15 Dec 2020 00:00:00 +0530 Bengaluru based startup Azooka Labs, a leading safe fluorophore company with specialisation in Molecular Biology products, reveals its first range of novel COVID-19 diagnostics products. RNA Wrapr is a molecular transport medium for COVID-19 sample collection, developed as part of the COVID-19 response team from Indian Institute of Science. RNA Wrapr inactivates the virus immediately only preserving DNA/RNA content required for RT-PCR tests. The sample tubes can be stored up to 7 days in room temperature and transported without dry ice or gel packs. RNA Wrapr is safe to handle even during unexpected accidental spillage or handling errors. Developing countries can collect samples in centres without BSL2 or BSL3 certifications. Azooka's RNA Wrapr is priced at Rs 99 in India, aligned with the price of one litre of petrol, to help the diagnostic centres upgrade from VTM to MTM. Azooka plans to enter the APAC market through partners with $9 and $6 pricing plans per test. "Azooka has actively been a part of the fight against COVID by developing PCR and RT PCR kits with support from Dept of Biotechnology and Elevate Karnataka even before the pandemic hit us" quoted Alex D Paul, CEO, Azooka Labs. He further added, "MTM has ensured safety and security of COVID-19 samples to be stored at Room Temperature for up to seven days". "Azooka is the only startup from India working to replace Carcinogenic and Mutagenic SYBR dyes widely used in RUO and Diagnostics reagents. Safety and cost savings needed for COVID crisis management today are the highlights of Azooka's MTM" said Dr C V Natraj, former SVP, Corporate Research, Unilever plc. "Azooka is striving to provide a safer molecular grade transport medium that is at sub Rs 100. We are appealing to a segment of users, who care about the safety of their frontline healthcare workers,” stated Dr Fatima Benazir, Co-founder & CSO, Azooka Labs. ]]> https://biospectrumindia.com/news/97/17773/higenomb-gets-icmr-ce-ivd-approval-for-its-covid-range-of-products.html https://biospectrumindia.com/news/97/17773/higenomb-gets-icmr-ce-ivd-approval-for-its-covid-range-of-products.html Mon, 14 Dec 2020 17:20:00 +0530 HiGenoMB®, the Molecular Biology Division of HiMedia Laboratories Pvt Ltd the leading Indian BioSciences manufacturer proudly announces that it has received the prestigious ICMR and CE/IVD approval for its COVID Range of Products. HiMedia Laboratories has also successfully launched the InstaNX® Mag Series of Automated DNA/RNA Extraction Platforms viz InstaNX®Mag32 capable of processing 32 samples & InstaNX®Mag96, the high throughput version capable of processing 96 samples. Hi-PCR® Coronavirus (COVID-19) Multiplex Probe PCR Kits (MBPCR243) is a RT-PCR Kit capable of detecting 4 different genes- N gene, E gene, RdRp gene and RPPH1 (Endogenous Internal Control) in the same assay. HiPurA® Viral RNA Purification Kit (MB615) - Manual Spin Column based kit has been the front runner amongst the COVID products for HiGenoMB®. HiMedia ensured timely and continuous supply of Manual Viral RNA Extraction Kits across the country during the initial stages of the pandemic making it the most sought after Indian manufacturer capable of meeting the demands of the COVID Diagnostic market. HiPurA® Viral RNA Purification Kit – Magnetic Bead Based (MB615M) was approved from ICMR-approved site NIV (Pune) along with its use with HiMedia’s Automated DNA/RNA Instrument- InstaNX Mag96. Dr Rajas Warke, Director, HiMedia’s Molecular Biology Division says ”During the initial days into the COVID-19 pandemic with very few signs being observed globally, we re-directed the R&D team towards development of COVID-19 molecular diagnostic products. The ICMR validation thus makes HiMedia synonymous with being a Complete Solution Provider for COVID Molecular Detection and being the Only Indian manufacturer in this capability.” “HiGenoMB® and team HiMedia, is proud to have introduced effective COVID products under the most challenging working conditions. Despite HiMedia’s research scientists also being affected by COVID-19, the rest of the team immediately stepped up the momentum to deliver COVID-19 related products successfully to our nation.” added Dr Kavita Khadke, Director, HiMedia’s Molecular Biology. ]]> https://biospectrumindia.com/news/97/17762/optralabs-receives-icmr-approval-for-covid-19-recovery-test-kits.html https://biospectrumindia.com/news/97/17762/optralabs-receives-icmr-approval-for-covid-19-recovery-test-kits.html Fri, 11 Dec 2020 17:25:00 +0530 Pune-based OptraLABS has announced that it has received approval from ICMR towards its COVID-19 rapid test kits named ‘Optra-Shield’. Based on studies conducted at the National Institute of Virology (NIV) Pune, ‘Optra-Shield' test kits showed 99% specificity & 95% sensitivity to detect immunity post-COVID-19 infection. These kits detect IgG antibodies which are developed a post-COVID-19 infection as a fighting mechanism of the body immune system. Once these antibodies are developed, the person becomes non-contagious and considered safe to intermingle with others. Optra-Shield comes with a mobile-based self-assessment app and at-home rapid test kit (like a glucose testing or pregnancy testing type of simple device). It comes with a lancet (a finger pricker) to obtain a drop of blood on the strip which in few minutes shows your immunity levels against COVID-19. Abhi Gholap, Founder and CEO, OptraLABS said, “These kits are particularly useful to test the effect of COVID-19 vaccine. We are not only manufacturing these in India but also made sure that our kits cost-effective. We are making Optra-Shield available at Rs 350 in India." Dr Achal Pashine, a well-known scientist and Ex-Director, Bristol Myers Squibb, GSK, and Roche said, “This kit can be utilised by the governmental health agencies to monitor the administration and efficacy of their immunisation programme. This could be monitored by user-submitted data after the vaccine recipient uses the COVID-Shield test at home post-vaccination after a prescribed time.” ]]> https://biospectrumindia.com/news/97/17759/ccmb-apollo-hospitals-collaborate-to-develop-cost-effective-covid-19-test.html https://biospectrumindia.com/news/97/17759/ccmb-apollo-hospitals-collaborate-to-develop-cost-effective-covid-19-test.html Fri, 11 Dec 2020 13:55:00 +0530 CSIR-Centre for Cellular & Molecular Biology (CCMB) in Hyderabad and the Apollo Hospitals Enterprise have announced a collaboration for joint manufacturing and commercialisation of an innovative dry swab test, Direct Amplification rapid RT-PCR (DArRT-PCR) - for SARS-CoV-2 detection. The test has been developed by CSIR-CCMB and the collaboration with Apollo Hospitals will focus on scaling up manufacturing and commercialisation of the tests jointly. The rapid, safe, and cost-effective DArRT-PCR tests will be available nationally through the Apollo Hospitals network. The DArRT-PCR allows for rapid, safer, and more cost-effective SARS-COV-2 testing. The sample collection centres can send dry nasal or oropharyngeal swabs to testing centres with no need for the imported and expensive Viral Transport Medium. The biological sample can be directly isolated from the patient swabs, and testing using a one-step protocol. The current gold-standard method, on the contrary, requires many expensive reagents and steps that add to the expertise, money, and time required for the tests. The DArRT-PCR test reduces the time and human effort by 40-50% in the current setting of testing. Dr Rakesh Mishra, Director, CSIR-CCMB applauded this collaboration and said, “Cheaper, rapid, and easy to use tests as these are the need of the hour. With Apollo and its vast network of hospitals and health services, we are positive about impacting many lives towards better health.” Dr Sangita Reddy, Joint Managing Director, Apollo Hospitals Group said, “We are glad to collaborate with CSIR-CCMB in this path-breaking initiative of a more rapid, easy to use, and accurate testing option and work to make it available nationwide. These tests will give a boost to the efforts to mitigate the effect of COVID-19 and will play a major role in controlling the pandemic.” ]]> https://biospectrumindia.com/news/97/17749/healthium-medtech-launches-first-indigenous-meniscal-repair-device.html https://biospectrumindia.com/news/97/17749/healthium-medtech-launches-first-indigenous-meniscal-repair-device.html Fri, 11 Dec 2020 00:00:00 +0530 Healthium Medtech, based in Bengaluru, has announced the launch of 'Surestitch™ – the first 'Made in India' meniscal repair device. Manufactured by Healthium as part of its arthroscopy range Sironix, Surestitch™ has an original product design with design patents applied in India and the US. Speaking on the launch, Anish Bafna, CEO, Healthium Group, said, “We are immensely proud to launch Surestitch™ - the first meniscal repair device designed and manufactured in India by an Indian Company. In a market dominated by foreign technology and brands, we have created an original design using Indian technology and inputs from Indian surgeons. This is our fourth innovation in a year as we continue to launch high quality precision based medical devices that drive simplicity of use for surgeons and bring patient safety to the fore." Speaking on the occasion Anoop Penupolu, Vice President – Sironix Arthroscopy Solutions, Healthium MedTech said, “Meniscal repair is a fast growing category and more and more surgeons are looking to preserve the meniscus today than in the past. We are looking at providing a simple and effective solution for meniscal repair, which if untreated could accelerate the onset of osteoarthritis. Surestitch™ has been designed to address surgeon need gaps and help the medical fraternity treat meniscus tear more effectively. This is a very important product for us which will help us complete the portfolio and gain share in this fast-growing category " Surestitch™ follows a simple 3 step process to repair the meniscus tear called – PTF (Pierce The Needle, Turn the Safety Knob and Fire the Implant). The device comes with a 17 gauge stiffer needle that ensures effortless piercing and a built in adjustable depth control sheet to prevent over insertion. Its safety knob prevents misfiring and the audible and visual confirmation ensures sequential implant selection. The device has an audible click feature that ensures implant deployment feedback and its ergonomic design enables single handed use. ]]> https://biospectrumindia.com/news/97/17742/clevergene-inks-mou-with-csir-to-sequence-sars-cov-2-genome-.html https://biospectrumindia.com/news/97/17742/clevergene-inks-mou-with-csir-to-sequence-sars-cov-2-genome-.html Wed, 09 Dec 2020 17:20:00 +0530 Bengaluru based Clevergene has entered into a Memorandum of Understanding (MoU) with the Council of Scientific and Industrial Research- Central Food Technological Research Institute (CSIR-CFTRI) in Mysuru to sequence the SARS-CoV-2 genome and derive valuable insights into virus genome changes (mutations), evolution, epidemiology, and provide an understanding of the spatial and temporal information on infection dynamics of the SARS-CoV-2 virus. As the COVID-19 pandemic continues to afflict the human population across the globe and many countries are experiencing the second wave of infections, there is a pressing need for India to enhance its pandemic fighting abilities and efforts. The SARS-CoV-2 virus, which is causing the COVID-19 pandemic, continues to mutate into different strains, making it difficult for the scientific and medical community to control or eradicate it. In such a scenario, the cutting-edge science of Genomics is coming to the rescue of mankind. There are major ongoing genomic projects in almost all countries, to understand the mutations, virulence, susceptibility and infection patterns of the SARS-CoV-2 virus. Using the power of Genomics, at Clevergene’s Next Generation Sequencing laboratory in Bengaluru, scientists at the CFTRI COVID Testing Lab, and team Clevergene, aim to work together towards unraveling better diagnostics and contributing to India’s efforts of genomic surveillance. CSIR-CFTRI has established a COVID-19 testing centre in Mysuru where it is testing an average of 1,000 samples daily. CFTRI is also working on the development of novel dipstick and aptamer-based diagnostics in collaboration with the industry. Under the MoU, the development of novel diagnostics and vaccines for COVID-19 are also envisaged. The MoU was exchanged between Dr B Manohar, Chief Scientist and Adviser – M&A and Tony Jose, Co Founder and CEO – Clevergene in the presence of senior CFTRI staff members.   ]]> https://biospectrumindia.com/news/97/17728/human-trial-for-real-time-breath-test-for-covid-19-detection-begins-in-delhi.html https://biospectrumindia.com/news/97/17728/human-trial-for-real-time-breath-test-for-covid-19-detection-begins-in-delhi.html Tue, 08 Dec 2020 13:10:00 +0530 US based companies, Canary Health Technologies and SmartShape Design, have collaborated to create ASU Detect CV19, an ultra-rapid, highly accurate breath test device for the detection of COVID-19.  The hand-held digital test requires minimal training and can be performed at the point of care, without the need of a laboratory.  Using exhaled volatile organic compounds found in human breath as biomarkers of the virus, ASU Detect CV19 is designed to detect the virus in people that are exhibiting symptoms or asymptomatic. While current available tests measure the viral load in a person to determine if they are infected, Canary's breath test detects the metabolic response almost immediately after infection and deliver results in less than three minutes. The current ASU Detect CV19 clinical trial taking place in Delhi, is the first and largest clinical trial using a real-time breath test for the detection of an infectious disease with cloud-based artificial intelligence for pattern recognition as the analytical tool. Trials in the US are being planned and due to begin before the end of 2020. If the trial is successful, Canary will seek to move quickly to apply for fast-track regulatory approval while continuing to trial the test in real-world settings such as airports, resorts and other high traffic areas. Raj Reddy, CEO, Canary Health Technologies’ believes Canary's breath diagnostic platform will be the future of COVID-19 detection as well as many other diseases. "Our cutting-edge technology enables easy, rapid testing every few days in order to optimise safety in workplaces and other settings. Our unique strength will be our ability to detect COVID-19 in under three minutes before the onset of symptoms which will be critical in reducing transmission and ultimately putting an end to this pandemic," says Reddy. Canary was able to develop this novel test for COVID-19 at top speed because the platform was already in advanced development to detect early stage lung cancer. Supporting Canary with industrial design and manufacturing has been both personally and professionally rewarding for Mike Maczuzak, CEO & Founder, SmartShape. "Everyone has been affected by this global pandemic and to know our team will have contributed to solving it – that really fuels my passion for healthcare innovation," says Maczuzak. ]]> https://biospectrumindia.com/news/97/17700/doctorc-forays-into-home-covid-19-testing-in-bengaluru.html https://biospectrumindia.com/news/97/17700/doctorc-forays-into-home-covid-19-testing-in-bengaluru.html Wed, 02 Dec 2020 18:40:00 +0530 DoctorC has expanded their diagnostic services existent in Bengaluru, by entering into Covid home services as a response to the second wave of the COVID-19 pandemic.   Starting from May 2020, the company has provided COVID-19 RT PCR tests in Hyderabad and Chennai. As the pandemic spreads and fear of a second wave shadows India, DoctorC is expanding the services to Bengaluru, Ahmedabad, Cochin, south Tamil Nadu and Kolkata as well. This initiative has been taken to serve and provide easy access to maximum people across the country. The right mix of partnered labs, hospitals & paramedics has collectively created a smooth & safe experience for their customers. Standing robust, DoctorC has dispensed hassle-free, affordable, and reliable home services during COVID-19. As an essential service provider, the company works only with National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited labs to ensure the premium quality of healthcare. In addition to this, DoctorC also takes appropriate safety measures to ensure that there is no unwanted spread of infection. Working closely with lab partners like Neuberg Diagnostics and Aarthi Scans, DoctorC aspires to assist customers across the country to get tests easily and in an hassle-free manner. Speaking about this announcement, Neehar Cheerabudi, CEO & Co-Founder, DoctorC said, “Our ultimate goal at DoctorC is to make testing easily available to maximum people. We aim to provide smooth testing along with uninterrupted services to the people of this country. Combating with the COVID-19 spread has become of paramount importance for our country as it is for the entire world. We will continue to serve our nation to the best of our capacity all the while ensuring the safety and affordability of our customers.” ]]> https://biospectrumindia.com/news/97/17692/sancheti-hospital-redefines-robotic-spine-surgery.html https://biospectrumindia.com/news/97/17692/sancheti-hospital-redefines-robotic-spine-surgery.html Tue, 01 Dec 2020 17:25:00 +0530 Sancheti Institute of Orthopaedics and Rehabilitation from Pune has launched redefined robotic spine surgery called 'O-arm spine navigation'.  The O-arm technique gives accurate real-time scans which help experts to take on-table decisions. A handful of doctors in the world use this technique, and it is introduced in Pune for the first time.  Doctors mentioned that when conventional techniques carry the small possibility of a patient getting paralysed post-operation or of acquiring an infection during operation, this redefined robotic spine surgeries can deliver superior outcomes.  Dr Parag Sancheti, Orthopaedic Surgeon and Chairman of Sancheti Institute of Orthopaedics and Rehabilitation, said, "O-arm is taking spine surgeries to another level by providing intraoperative 3D imaging. Before a procedure, a full 360-degree scan can be performed in just a few seconds. Then it can demonstrate the proposed position of screws or rods in the spine before they are even applied, and then it confirms its position once placed. As a result of this technology, the effectiveness of the surgery improves, there are fewer complications and the patient and surgical team are exposed to less radiation."  Dr Ajay Kothari, Orthopaedic Spine Surgeon, Sancheti Institute of Orthopaedics and Rehabilitation, said, "With the O-arm technique, we can monitor all the developments in real-time. There is no need for a CT scan or MRI post-operation as we can see it on the operation table in real-time. This was not possible before. The accuracy in placement of screws or rods is made possible because of the O-arm technique, thereby reducing the risk of errors. Also, patient safety is maximum with this technique. There is almost no risk of paralysis for the patient. Also, it helps surgeons in achieving precision during the surgery."  How O-arm is taking spine surgery to another level: it gives real-time scan image it helps in precision and accuracy in placing spinal instruments like screws and rods it increases the safety of patients it ensures maximum resection of spinal tumours ]]> https://biospectrumindia.com/news/97/17690/tcs-deploys-blockchain-based-solution-to-scale-up-covid-19-testing.html https://biospectrumindia.com/news/97/17690/tcs-deploys-blockchain-based-solution-to-scale-up-covid-19-testing.html Tue, 01 Dec 2020 17:00:00 +0530 Tata Consultancy Services, a leading global IT services, consulting and business solutions organisation, announced that it has deployed a blockchain-based digital supply chain platform that powers an ambitious new project launched by the Government of India’s Centre for Cellular and Molecular Platforms (C-CAMP) to scale up indigenous COVID-19 diagnostic test-kit production capacity to a million test kits a day.  C-CAMP’s newly launched project, funded by the Rockefeller Foundation, is called Indigenisation of Diagnostics (InDx), and aims to build a robust, scalable supply-chain ecosystem of Indian MSMEs capable of producing large quantities of reagents and other components needed for RT-qPCR-based and other diagnostic test kits for COVID-19. The project entails eliminating supply-chain bottlenecks, and handholding MSMEs to help them bridge capability gaps, meet necessary quality standards and expand capacities to be able to indigenously produce a million test kits a day.   As C-CAMP’s technology partner, TCS has developed and deployed a dynamic digital supply-chain platform to manage the MSME ecosystem, powered by the TCS Data Marketplace solution. The solution enables organisations to embrace new ecosystem-based business models, giving them the ability to democratise data and monetise it to create value. It facilitates standardised, controlled data exchanges across ecosystem participants with the necessary security and privacy protection, using blockchain at the back-end to ensure the immutability of audit logs.   This capability has been harnessed in the InDx project to build a supply-chain platform that aggregates test kit supply data of Tier 2 and 3 manufacturers of kits, enzymes, primers and antibodies, and provides ready visibility to Tier 1 suppliers as well as to C-CAMP on supplier-specific quality levels, capacities and inventories across the ecosystem, enabling the latter to respond to the demand for those test kits from the Government as testing programs are ramped up across the country.  “The TCS Data Marketplace solution is the lynchpin that anchors InDx’s supplier ecosystem of micro, small and medium enterprises, democratising supplier data, enhancing supply-chain visibility, and driving superior outcomes for all stakeholders,” said Dinanath Kholkar, Global Head – Analytics and Insights, TCS. ]]> https://biospectrumindia.com/news/97/17675/icmr-approves-dry-swab-direct-rt-pcr-method-for-covid-19-testing-.html https://biospectrumindia.com/news/97/17675/icmr-approves-dry-swab-direct-rt-pcr-method-for-covid-19-testing-.html Mon, 30 Nov 2020 12:30:00 +0530 The simple and fast method of Dry Swab-Direct RT-PCR, developed by CSIRs constituent lab Centre for Cellular and Molecular Biology (CCMB) Hyderabad for scaling up of SARS-CoV-2 detection has now been approved by ICMR based on their independent validation. This method developed by CSIR-CCMB is a simple variation of the existing gold standard RT-PCR method and can easily scale up the testing by 2 to 3 fold with no new investment of resources.  After evaluating this method and finding an overall concordance of 96.9 per cent, ICMR has now issued an advisory for the use of CSIR-CCMB dry swab method, considering its lesser cost and quick turn-around time. More specifically, the Dry Swab-Direct RT-PCR method involves collecting and transporting the nasal swab in dry state (as opposed to using the viral transport medium VTM) which makes the transportation and handling of the samples easy and less prone to spillage and spread of infection. Secondly, the step of RNA isolation from the sample is omitted and involves only simple processing of the sample followed by direct RT-PCR using the kit recommended by ICMR. Omitting the step of RNA isolation offers a huge benefit over the conventional method, as the RNA isolation is a major bottleneck in terms of time, cost and trained manpower. Given this, with the same resources and no additional cost more samples can be tested and can be easily scaled up at least 2-3 times immediately. Significantly, the modified method of CSIR-CCMB has also been independently corroborated by multiple premier institutes and hospitals such as Centre for DNA Fingerprinting and Diagnostics (CDFD), IISER-Berhapmur, CSIR-NEERI, GMCH-Nagpur, Genepath based in Pune, IGGMSH and MAFSU, Nagpur and also Apollo Hospitals, Hyderabad. Further, this modified method has been published in peer reviewed journal by CSIR-CCMB and by other scientific groups in several prestigious scientific journals across the world.   ]]> https://biospectrumindia.com/news/97/17660/-cosara-receives-cdsco-approval-for-covid-19-2-gene-multiplex-test.html https://biospectrumindia.com/news/97/17660/-cosara-receives-cdsco-approval-for-covid-19-2-gene-multiplex-test.html Thu, 26 Nov 2020 12:45:00 +0530 Co-Diagnostics Inc, a US based molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, has announced that CoSara Diagnostics Pvt Ltd (CoSara), its joint venture for manufacturing and sales in Vadodara, has received clearance by the Central Drugs Standard Control Organisation (CDSCO) to manufacture and sell its Saragene™ COVID-19 2-gene multiplex RT-PCR test as an in vitro diagnostic (IVD), intended for the qualitative detection of the SARS-CoV-2 virus. The Saragene test kit approved by the CDSCO uses the Company's patented CoPrimer™ technology and is based on a test originally designed by Co-Diagnostics, who also recently announced receipt of a CE marking for its Logix Smart™ SARS-CoV-2 (genes RdRp/E) multiplex test. Both the CoSara and Co-Diagnostics test target two gene markers of the SARS-CoV-2 genome, RdRp and E-gene, to identify the presence of the virus, and were designed to meet the needs of those markets where government or regulatory bodies recommend a multi-target coronavirus diagnostic. Dwight Egan, CEO, Co-Diagnostics, commented, "Tests built on our CoPrimer technology have several advantages over other platforms, including the enhanced multiplex capabilities. We believe that the highly specific nature of the new Saragene test which follows World Health Organization guidance will help CoSara be able to play an even more active role in the battle against this pandemic." Mohal Sarabhai, Director, CoSara remarked, "Our honourable Prime Minister has endorsed the hike in number of available RT-PCR tests to keep the COVID-19 positivity rate under 5 per cent. With this clearance in place, CoSara is geared up for this challenge by providing affordable, high quality, 'Made in India' 2-gene multiplex COVID-19 RT-PCR tests across the country." CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) to be manufactured and sold as IVDs in the Indian market. ]]> https://biospectrumindia.com/news/97/17650/omron-invests-65-million-into-alivecor-for-remote-cardiovascular-condition-management.html https://biospectrumindia.com/news/97/17650/omron-invests-65-million-into-alivecor-for-remote-cardiovascular-condition-management.html Tue, 24 Nov 2020 18:20:00 +0530 Omron Healthcare Co, Ltd announced on November 24 additional investment into AliveCor by its parent company, Omron Corporation, as part of $65 million series E funding for the leader in AI-based personal electrocardiogram (ECG) technology. Omron led this round of investment, reinforcing the cross-company collaboration that began in 2017. The companies continue to build on their global alliance to accelerate development of solutions for cardiovascular disease management and remote patient monitoring utilising ECG technology. "Omron is committed to developing life-saving cardiovascular health technologies in pursuit of our 'Going for Zero' vision to eliminate heart attacks and strokes. That is why we seek like-minded partners, like AliveCor, to advance our initiatives and work together to save lives," said Isao Ogino, President and CEO, Omron Healthcare. "Our alliance with AliveCor will help enhance our current technology portfolio and provide hypertensive patients and healthcare professionals with data that can save lives--a complete picture of patients' cardiovascular health that can be achieved with personal remote monitoring technology used at home,” said Ogino. Omron's expanded investment into AliveCor builds upon the companies' ongoing collaboration. Omron expanded its blood pressure monitor portfolio with the launch of ‘Complete’ (TM) the first blood pressure monitor with ECG capability in a single device and the first FDA-cleared technology developed in collaboration with AliveCor in 2019. Currently available in the US at OmronHealthcare.com and participating retailers, expanded distribution of Complete (TM) is expected in other regions globally during the company's fourth quarter. ]]> https://biospectrumindia.com/news/97/17646/healthium-launches-indias-1st-knotless-tissue-closure-device-.html https://biospectrumindia.com/news/97/17646/healthium-launches-indias-1st-knotless-tissue-closure-device-.html Tue, 24 Nov 2020 14:55:00 +0530 Bengaluru based Healthium Medtech, one of the largest medical device companies in India, has announced the launch of its latest innovation Trubarb – a knotless tissue closure device designed to redefine the suturing experience for surgeons. The device comes with barbs and an effective triangular end stopper that eliminates the need for knotting when compared to a regular suture and eliminates the difficulties of looping when compared to other knotless sutures. It has been designed to shorten suturing time, decrease morbidity and ischemic necrosis that arise due to knotting and simplify the overall suturing experience for surgeons. Sutures are amongst the most used products during surgeries, however, the only significant advances on sutures have been sterilization in 1870ies and synthetic absorbable sutures in 1960ies. By eliminating the need for knotting which is considered a necessary evil in suturing as it reduces the tensile strength of the suture by thinning it, creating a weak spot and building uneven tension across the wound, and by eliminating the unmet needs of wound dehiscence, knot slippage, ischemic necrosis due to knotting and increase in blood loss and morbidity especially in Laparascopic surgeries, Trubarb is looking to redefine the wound closure experience for surgeons.  The device has multiple applications and can be used for procedures such as gynaecological, general surgery procedures, urology, oncology and plastic & cosmetic surgeries. ]]> https://biospectrumindia.com/news/97/17643/ge-healthcare-uses-ai-to-assess-ett-placement-for-covid-19-patients.html https://biospectrumindia.com/news/97/17643/ge-healthcare-uses-ai-to-assess-ett-placement-for-covid-19-patients.html Tue, 24 Nov 2020 11:50:00 +0530 GE Healthcare has announced a new artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements, a necessary and important step when ventilating critically ill COVID-19 patients. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control. Research shows that up to 25 percent of patients intubated outside of the operating room have misplaced ETTs on chest x-rays, which can lead to severe complications for patients, including hyperinflation, pneumothorax, cardiac arrest and death. Up to 45% of ICU patients, including severe COVID-19 cases, receive ETT intubation for ventilation. While proper ETT placement can be difficult, Critical Care Suite 2.0 uses AI to automatically detect ETTs in chest x-ray images and provides an accurate and automated measurement of ETT positioning to clinicians within seconds of image acquisition, right on the monitor of the x-ray system. In 94% of cases, the ET Tube tip-to-Carina distance calculation is accurate to within 1.0 cm. GE Healthcare’s algorithms are a fast and reliable way to ensure AI results are generated within seconds of image acquisition, without any dependency on connectivity or transfer speeds to produce the AI results. Results are then sent to the radiologist while the device sends the original diagnostic image, ensuring no additional processing delay. The AI suite also includes several quality-focused AI algorithms to analyze and flag protocol and field of view errors, as well as auto, rotate the images on-device. ]]> https://biospectrumindia.com/news/97/17634/academia-industry-partnership-crucial-for-optimising-productivity-of-medical-devices.html https://biospectrumindia.com/news/97/17634/academia-industry-partnership-crucial-for-optimising-productivity-of-medical-devices.html Fri, 20 Nov 2020 16:05:00 +0530 Bringing to the discussion about the current trends; challenges and opportunities in ‘MedTech Industry’; optimising productivity through collaboration and the role of ‘Make in India’ initiative in making India self-reliant, ‘India Med Tech E-Summit 2020 was organised by HEAL Health Connect Solutions in association with ESI MedTech Solutions and the knowledge partner HEAL Foundation on November 19, 2020. Speaking on the reduced dependency on imports and making India self-sufficient through ‘Make in India’ initiative during ‘India Med Tech E-Summit 2020’ — the 11th Episode of HEAL-Thy Samvaad, Parag Varshney, Director, International Institute for Human Development, India said, “Academia-industry partnership will help reduce the dependency on imports and make India self-sufficient through ‘Make in India’ initiative.” Moderating the ‘India Med Tech E-Summit 2020’, Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd., Forum Co-ordinator, AiMeD said, “Academia and industry collaboration is good for incremental innovation in the field of manufacturing devices and competitive advantages, but to make a completely new product, it would be prudent to reach out to the foreign manufacturers and do technical collaboration and licensing with them.” Chairman of the organising committee ‘India Med Tech E-Summit 2020’, Dr P Siva Kumar, Managing Director, ESI MedTech Solutions said, “Make in India should be the focus; trends and opportunities in medical technology and reducing the challenges and opportunities in medical devices.” While speaking on the current state of technology and infrastructure in India, Dr Taslim Arif Saiyed, CEO & Director, The Centre for Cellular & Molecular Platforms (C-CAMP), said, “We are largely involved in innovation and it is absolutely mind boggling to see there is innovation in medical technology. We need to scale up the opportunity and bring high quality products.” Dr Nilesh Shah, President and Chief of Science & Innovation, Metropolis Healthcare Ltd, said, “For meeting the current demands and future requirements, we need to have small to medium innovations.” “Digital technology has the potential to unleash the problems of medical technology and a great help in bringing innovation. Clouds, e-Hospitals, AI Machine Learning and Telemedicine are some of the living examples of digital technology in healthcare delivery,” said Amit Mohan, Chief Operating Officer, LCS Digital & Inside Sales, GE Healthcare, (South Asia).  ]]> https://biospectrumindia.com/news/97/17629/apollo-hospitals-to-roll-out-10000-crispr-cas-9-tests-in-ncr-for-covid-19-detection.html https://biospectrumindia.com/news/97/17629/apollo-hospitals-to-roll-out-10000-crispr-cas-9-tests-in-ncr-for-covid-19-detection.html Thu, 19 Nov 2020 18:10:00 +0530 Apollo Hospitals Group and Tata Medical and Diagnostics (TataMD), the new healthcare venture of the Tata group, has announced a collaboration to introduce TataMD Check, the world’s first CRISPR Cas-9 based diagnostic test, to help increase testing for COVID-19 across the country. Apollo Hospitals, along with its subsidiary, Apollo Diagnostics will offer the TataMD Check testing in the National Capital Region (NCR) from the first week of December 2020 and shortly thereafter, it will be rolled out across all major centres, namely Kolkata, Mumbai, Hyderabad, Bangalore, Chennai, Ahmedabad and Pune, followed by a second phase into other cities. This significant tie-up with Apollo Hospitals kicks off the efforts of TataMD Check to align with healthcare institutions including hospitals, diagnostic chains and other healthcare facilities. During the next few weeks, Apollo Hospitals group will ensure the availability of TataMD Check testing in eight hospitals in phase one and the location-wise quantities will be ramped up based on the demand and need for expanding this to other centres. Tata MD will help train the key diagnostic clinicians and staff at Apollo Hospitals and Apollo Diagnostics on new technology and effective testing protocols in the next few weeks. Commenting on this initiative, Dr Sangita Reddy, Joint Managing Director, Apollo Hospitals (AHEL) and Managing Director, Apollo Health and Lifestyle Limited (AHLL) said, “The addition of Tata MD Check as part of the testing arsenal will be a boost to the ongoing efforts that the country has been waging against this pandemic. We at Apollo are happy to partner with the Tata Group in what is potentially a revolutionary advancement in the Covid Testing Landscape.” “We believe that the association with Apollo Hospitals will catalyse the rapid adoption of TataMD Check as the efficient and preferred testing option as we begin to resume our lives again,” added Girish Krishnamurthy, CEO & MD, Tata Medical and Diagnostics. TataMD Check test kits are being manufactured at a quality-controlled production facility near Chennai, Tamil Nadu. ]]> https://biospectrumindia.com/news/97/17625/abbott-launches-heart-valve-repair-device-to-treat-mitral-regurgitation.html https://biospectrumindia.com/news/97/17625/abbott-launches-heart-valve-repair-device-to-treat-mitral-regurgitation.html Thu, 19 Nov 2020 15:55:00 +0530 Abbott has launched its clip delivery system, a minimally invasive heart valve repair device to treat mitral regurgitation in India. This product puts new technology into the hands of physicians by giving them a life-saving treatment option that may be used for people suffering from mitral regurgitation due to a heart defect or as a result of heart failure. This clip device repairs leaky mitral valves without open-heart surgery and is delivered to the heart through a vein in the leg. The device clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood (known as mitral regurgitation, or MR), restoring the heart's ability to pump oxygenated blood more efficiently. To date, this product has helped treat more than 100,000 people worldwide suffering from MR and is supported by the industry’s most extensive body of clinical evidence, including the results of the landmark COAPT Trial published in The New England Journal of Medicine in September 2018. In addition, the device’s safety and efficacy is also supported by 3 randomized clinical trials, over 30,000 people enrolled in clinical studies and 1000+ publications. With more than 16 years of clinical experience, Abbott’s mitral clip system is the first and only transcatheter mitral valve therapy with proven safety and survival, and durability of clinical outcomes. Dr. Sai Satish, internationally renowned Senior Interventional Cardiologist from Apollo Hospitals, India, and practicing interventional cardiologist and Director Structural Heart (International) Gottsegen Institute of Cardiology, Budapest, Hungary, said "Not all patients with a leaky mitral valve are suitable for open-heart surgery due to advanced age or other co-morbidities. Till now there was little we could do for them. This procedure is a non-surgical treatment option for these patients which has been proven to dramatically reduce symptoms and improve not just their quality of life, but also survival.” Dr. Ravinder Singh Rao, MD, DM, FACC, Director, TAVI and Structural Heart Disease Program, Consultant Interventional Structural Cardiologist, Eternal Hospital, Jaipur said, “Mitral regurgitation with poor left ventricular function carries a poor prognosis. Medicines alone cannot cure this mechanical problem, and only help the heart tolerate it better. Open heart surgeries have risks for some patients.” According to a study by The Lancet, cardiovascular diseases caused 28 percent of deaths in 2016, which was double the numbers reported in 1990 when it caused 15 percent of deaths in the country – from 1.3 million in 1990 to 2.8 million in 2016 in India. ]]> https://biospectrumindia.com/news/97/17624/medgenome-shows-novel-variations-in-common-genetic-disorders-in-india.html https://biospectrumindia.com/news/97/17624/medgenome-shows-novel-variations-in-common-genetic-disorders-in-india.html Thu, 19 Nov 2020 15:40:00 +0530 In a recent research study, Bengaluru based MedGenome Labs, the leaders in genetic testing in India, in partnership with Sir Ganga Ram Hospital, New Delhi, conducted a pilot study to determine the carrier frequency and to look for any novel mutations seen in the Indian population for common genetic disorders. The study was conducted over a period of 22 months with a sample size of 200 unrelated individuals, in the North Indian population. After pre-test genetic counseling, the 200 individuals were screened for pathogenic variants in shortlisted 88 genes using Next Generation Sequencing (NGS) technology. These variants were classified as per the guidelines of American College of Medical Genetics. The study was facilitated by MedGenome Laboratories Bangalore, who carried out the molecular analysis, using NGS and the data was re-analyzed at Sir Ganga Ram Hospital, New Delhi. Out of the 200 participants, 52 (26%) were found to be carriers of one or more rare genetic disorders, 12 individuals (6%) were identified to be carriers for congenital deafness and the 9 individuals (4.5%) were observed to be carriers for cystic fibrosis. Three individuals were detected to be carriers for Pompe disease. This study showed a higher carrier frequency for these disorders which was contrary to the generally held view about their low prevalence in Asian Indians. Another interesting finding was that the disease-causing variants observed for disorders such as deafness, cystic fibrosis, Pompe disease, Canavan disease, primary hyperoxaluria, junctional epidermolysis bullosa, galactosemia, medium chain acyl CoA deficiency etc. were different from what is seen in the Western population. Thus, this pilot study highlights the importance of having a Genetic Variant Database for the Indian population. ]]> https://biospectrumindia.com/news/97/17615/roche-pharma-launches-pan-tumor-liquid-biopsy-test-in-india.html https://biospectrumindia.com/news/97/17615/roche-pharma-launches-pan-tumor-liquid-biopsy-test-in-india.html Wed, 18 Nov 2020 14:05:00 +0530 Roche Products (India) Pvt. Ltd. (Roche Pharma India) has announced the launch of FoundationOneLiquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy test for patients with solid tumors in India. US FDA approved the FoundationOneLiquid CDx, comprehensive genomic profiling (CGP) test on August 26. This is the first test that can analyze more than 300 genes and multiple genomic signatures to optimize patient care. Cancer is a disease of the genome. Most tumours harbour a constellation of genomic alterations that may dictate their clinical behaviour and treatment response. Blood-based biomarker testing options like FoundationOneLiquid CDx can help expand access to genomic insights in patients with advanced cancer as compared to a tissue biopsy, which may not be an option for many patients due to reasons such as tumour location and patient’s health status. FoundationOneLiquid CDx is a single non-invasive test based on Next Generation Sequencing technology that gives access to genomic information of over 300 genes. Additionally, the report also provides information about the biomarker signatures microsatellite instability (MSI), and blood tumor mutational burden (bTMB) to support informed decision making for targeted and immunotherapies. It is becoming increasingly important to provide personalised treatment options to the patients as it has an unprecedented scope in changing the paradigm of cancer care in the future. FoundationOneLiquid CDx is mainly prescribed in the metastatic cancers i.e. at stage IV of the disease. The test samples collected from the patients in India are sent to Foundation Medicine Inc.’s lab in Cambridge, MA, US where the test is performed. The patients are required to discuss with their treating physicians on their eligibility for this test. ]]> https://biospectrumindia.com/news/97/17600/lifecell-opens-diagnostic-lab-for-mother-child-screening-in-bengaluru-.html https://biospectrumindia.com/news/97/17600/lifecell-opens-diagnostic-lab-for-mother-child-screening-in-bengaluru-.html Mon, 16 Nov 2020 11:50:00 +0530 In an effort to reduce turnaround times for tests related to pregnancy health checks including COVID-19 testing, LifeCell has announced the launch of its brand new modern Diagnostic Laboratory in Bengaluru dedicated to the complete protection of mother and child. As an exclusive lab for mother & child, this new facility will also offer tests for assessment of pregnancy health inviting genetics testing and RT-PCR testing apart from other routine diagnostic tests. Committed to provide the safest screening test available to its community (mother and child), the new laboratory has already received accreditations from the Indian Council of Medical Research (ICMR) & National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditations for COVID-19 RT-PCR testing. LifeCell will now offer RT-PCR testing through Chennai, Nellore (third party collaboration), and Bengaluru laboratories to accommodate the growing demand. Till date, nearly two lakh samples have already been tested. This new addition to the world-class diagnostic capabilities will further support LifeCell’s commitment towards servicing COVID testing requirements through RT-PCR, and antibody tests, along with allied tests for parameters such as IL-6 and D-Dimer protein fragment, used for monitoring patients. Commenting on this development, Mayur Abhaya, Managing Director, LifeCell, said, “It is our paramount commitment to set up pan-India satellite labs to become more accessible to our customers and offer them exceptional services in such unprecedented times. We further plan to launch at least two more satellite labs in the next six months.”  The pricing of COVID-19 tests will remain as per state government-stipulated guidelines. The documentary requirements will be in adherence to the norms set by ICMR and will include a government-approved photo ID, and ICMR Specimen Referral Form for COVID-19. LifeCell will also continue to offer doorstep sample collection facilities to provide a convenient testing experience to the patients and their families.  ]]> https://biospectrumindia.com/news/97/17562/tata-group-unveils-first-crispr-cas-9-based-diagnostic-tool-for-covid-19.html https://biospectrumindia.com/news/97/17562/tata-group-unveils-first-crispr-cas-9-based-diagnostic-tool-for-covid-19.html Mon, 09 Nov 2020 13:10:00 +0530 Tata Medical and Diagnostics Ltd (TataMD), the healthcare venture from Tata Group, has announced the commercial launch of TataMD CHECK, a novel diagnostic testing for COVID-19. TataMD CHECK is powered by FELUDA, a CRISPR Cas-9 technology that was developed in India by CSIR- IGIB for COVID testing. It is the world’s first CRISPR Cas-9 based diagnostic tool to be launched globally. Within a short span of 100 days from licensing the technology to its commercial launch, intense collaboration between the CSIR-IGIB team, other reputed scientific research bodies and the Tata MD R&D team helped develop, a compelling end-to-end diagnostic solution that will set the new standard in testing. TataMD CHECK has been approved by Indian Council of Medical Research and Drug Controller General of India (DCGI) and will be available through diagnostic centres and hospitals across India shortly. Advantages of TataMD Check testing are: Simplicity: It is a paper strip-based test with an image-based visual result read out. It requires standard laboratory equipment and small batches of tests can be conducted. Quick Results: Fast reaction time of 45-50 minutes in the laboratory and the total testing time from RNA-extracted sample in the lab to result is 75 minutes only. Scalability: Ability to provide high quality, quick results using standard equipment and minimally trained staff allows for rapid adoption and scale with potential to reach remote locations of the country. Digital backbone: Continuous quality control using sensors and AI-based result reporting tool will help patients and authorities with the evidence of test, traceability of the sample and results accessible anywhere on cloud storage. Commenting on the launch, Girish Krishnamurthy, CEO, Tata Medical and Diagnostics said, “With TataMD CHECK, we are committed to significantly enhance the testing experience of the consumers as well as work with laboratories and hospitals to ensure wider availability and easier access to testing.” TataMD Check test kits will be manufactured at a quality-controlled production facility near Chennai, Tamil Nadu. The production plant presently has a capacity of producing one million kits in a month. ]]> https://biospectrumindia.com/news/97/17553/eepc-india-nid-collaborate-to-elevate-medical-devices-industry-.html https://biospectrumindia.com/news/97/17553/eepc-india-nid-collaborate-to-elevate-medical-devices-industry-.html Fri, 06 Nov 2020 17:50:00 +0530 EEPC India, the apex body of the engineering export organizations, and the National Institute of Design (NID) have joined together to promote and upgrade the designs and technology for the medical devices industry, enabling it to meet the emerging needs of the country's health sector, particularly in the aftermath of COVID-19 pandemic. With a view to taking the innovative and superior designs to the implementation level, the MSME Ministry has approved seven incubation ideas for the health sector under a special government scheme, DK Singh, Additional Secretary and Development Commissioner (MSME) said. He was addressing a webinar at the launch of the EEPC India-NID Design Series. It has been titled as: Post COVID-19- Design Intervention for Medical Device Industry.  He said the first design series had been proposed for the medical sector. ''During this pandemic situation of COVID-19, the country is trying to tackle the situation to overcome this difficult phase. We are able to produce over two lakh PPE kits in a day to fight COVID-19. Medical devices have been one of the key import-dominant sectors in our country. Dependence on complex medical devices for critical care is technology centric and calls for a consistent focus on innovation and design,’' Singh said. In his welcome address, Mahesh Desai, Chairman, EEPC India said his council is bringing together policymakers, researchers, designers and industry on a common platform to discuss the possibilities of design in the country in the wake of new and unexpected needs of healthcare facilities due to the outbreak of COVID-19. Praveen Nahar, Director, NID, said even in simple products like physiotherapy machines or ECG machines, design plays a very important role in bringing innovation and competitiveness. There are many examples of simple and contextual design improvements in such products that have transformed the way of doing business for Indian MSMEs.   ]]> https://biospectrumindia.com/news/97/17551/medgenome-launches-test-to-help-clinicians-on-immunotherapy-for-cancer-patients.html https://biospectrumindia.com/news/97/17551/medgenome-launches-test-to-help-clinicians-on-immunotherapy-for-cancer-patients.html Fri, 06 Nov 2020 17:15:00 +0530 MedGenome Labs, India’s leading genomics-driven research and diagnostics company launched Tumour Mutation Burden (TMB) test to help clinicians take informed decision on immuno-therapy for their cancer patients. Immuno-therapy is a concept in cancer treatment, where the approach is to use body's immune system to kill the cancer cells. A crucial aspect of success of tumour mutation burden test is that the body's immune system should differentiate cancer cells and normal cells. The mechanism by which the body's immune system can differentiate between cancer cells and normal cells is based on the expression of ‘neo-antigens’. Neo-antigens are altered self-proteins which result from a change in the self-protein due to a mutation. Thus, the key factors leading to expression of neo-antigens on the cell surface is presence of mutation in the cancer cell exome. TMB is defined as the total number of nonsynonymous mutations in the tumour exome. Tumour cells are genetically unstable and harbor high levels of somatic mutations which may result in the expression of neoantigens. The presentation of tumor-specific neoantigens on major histocompatibility complex molecules is essential for the recognition of tumours by the T-cells of the immune system. This induces a  T-cell response towards patient-specific neoantigens. These tumours may be eligible to successful immune-mediated destruction if their T-cell-dependent immune responses against tumour cells could be overreached. Dr VL Ramprasad, CEO, MedGenome Labs said “The test will help clinicians identify how many mutations occur in a given length of DNA to understand whether immunotherapy would work.” Food and Drug Administration granted accelerated approval to pembrolizumab for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumours, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.   ]]> https://biospectrumindia.com/news/97/17550/aster-labs-unveils-digital-pathology-solution.html https://biospectrumindia.com/news/97/17550/aster-labs-unveils-digital-pathology-solution.html Fri, 06 Nov 2020 16:50:00 +0530 Aster Labs, the diagnostics arm of Aster DM Healthcare, has introduced US FDA approved digital pathology solution by Philips Intellisite Pathology Solutions for primary diagnosis at its state-of-the-art reference lab located at Queens Road in Bangalore and at Aster Medcity in Kochi. With the inclusion of this cutting-edge technology, Aster Labs is looking to completely digitize its histopathology workflow and will be taking a step towards building a networked pathology system in the country.   The decision to implement digital pathology solutions at its centers is an important milestone for the brand as it further strengthens its commitment towards making world-class diagnostics accessible to every Indian.    As the incidences of chronic and complex diseases such as cancer have been on the rise in recent years, the need and demand to revamp the pathology industry in the country is now being realized more than ever before. Technology, both in the field of scanning and IT, has now finally met the necessary standards for digital pathology, in terms of software maturity and network, computing, and storage capability. Digital pathology, thus, now has the potential to provide solutions to the immediate implications of our patient care as well as the digital workflow. It can efficiently eliminate issues with handling material and could detect abnormalities as they occur.    Along with the implementation of digital pathology solutions across all its centers, Aster Labs also plans to build a value-based pool of talent of general histopathologists and aims to become a CoE (Centre of Excellence) for subspecialty FTR (First Time Right) reporting and other advanced subspecialties like transplant pathology, dermatopathology, neuropathology, and renal pathology, etc.   Sharing his views, K.R. Jayaprakash, Chief Operating Officer, Aster Labs, said: “This advanced technology platform, will not only improve our Turn Around Time (TAT) and bring in efficiency in the reporting system but will also aid our histopathologist in accessing the traditional cases like Appendix and Hysterectomy, etc. irrespective of their location. The best advantage of this technology is that several people can review the slides at the same time, in separate geographies, and through a combination of expert opinions, the team can arrive at the best conclusion that would benefit the patient and will assist them with accurate diagnosis. This will also ease the concern of collateral implications which is often faced by the patents due to human errors. ”  ]]> https://biospectrumindia.com/news/97/17531/medgenome-introduces-tumor-mutation-burden-test.html https://biospectrumindia.com/news/97/17531/medgenome-introduces-tumor-mutation-burden-test.html Wed, 04 Nov 2020 15:55:00 +0530 MedGenome Labs has recently launched Tumor Mutation Burden (TMB) test to help clinicians make an informed decision on immuno-therapy for their cancer patients. Immuno-therapy is a concept in cancer treatment, where the approach is to use body's immune system to kill the cancer cells. A crucial aspect of success of tumor mutation burden test is that the body's immune system should differentiate cancer cells and normal cells. The mechanism by which the body's immune system can differentiate between cancer cells and normal cells is based on the expression of ‘neo-antigens’. Neo-antigens are altered self-proteins which result from a change in the self-protein due to a mutation. TMB is defined as the total number of nonsynonymous mutations in the tumor exome. Tumor cells are genetically unstable and harbor high levels of somatic mutations which may result in the expression of neoantigens. The presentation of tumor-specific neoantigens on major histocompatibility complex molecules is essential for the recognition of tumors by the T-cells of the immune system. This induces a  T-cell response towards patient-specific neoantigens. These tumors may be eligible to successful immune-mediated destruction if their T-cell-dependent immune responses against tumor cells could be overreached. Food and Drug Administration granted accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Dr. V L Ramprasad, CEO, MedGenome Labs, Bengaluru said “This is a revolutionary step in the field of cancer and will change the way immunotherapy is prescribed in cancer. The test will help clinicians identify how many mutations occur in a given length of DNA to understand whether immunotherapy would work. Tumor Mutation Burden test by MedGenome provides quantification in terms of TMB score as well as accurate information on actionable gene mutations. Extensive validation for TMB panel was performed in-house on different cancer types from Indian population and international reference standards.” ]]> https://biospectrumindia.com/news/97/17493/genbody-partners-with-vishat-diagnostic-to-distribute-antigen-test-kits-in-india.html https://biospectrumindia.com/news/97/17493/genbody-partners-with-vishat-diagnostic-to-distribute-antigen-test-kits-in-india.html Thu, 29 Oct 2020 01:05:00 +0530 Genbody Inc., based in South Korea, has recently received approval from ICMR (Indian Council of Medical Research) and Drugs Controller General of India (DCGI) to supply its high accuracy antigen test kits in India, named as ‘Genbody Covid-19 AG’. The medical diagnostic firm has partnered with Mumbai-based Vishat Diagnostic to distribute the test kits in India. To counter high rates of false negatives with antigen tests, the company has designed this kit to optimize for accurate results. The test yields specificity of 98.0% and sensitivity of 90% and an accuracy of 94.0% making it one of the most accurate antigen tests in India. It also successfully validated the stringent ICMR criteria for antigen tests approval. Genbody Covid-19 AG produces results within 15 minutes after the hospital takes a sample from the patient's nasal or throat with a swab. The kit is a point of care test, performed within or outside conventional laboratory settings. Samples should be collected via the nasopharyngeal route and tested within one hour of sample collection. Vishat Diagnostic, MD Pratik Chitalia said, “We are happy to associate with the global diagnostic firm Genbody to supply high accuracy antigen test kits in India. Along with RT-PCR testing, this will strengthen our product offering to fight the pandemic with full force. ”     ]]> https://biospectrumindia.com/news/97/17488/cipla-commercializes-igg-elisa-test-for-covid-19-detection.html https://biospectrumindia.com/news/97/17488/cipla-commercializes-igg-elisa-test-for-covid-19-detection.html Wed, 28 Oct 2020 17:50:00 +0530 Mumbai-based Cipla Limited has announced the commercialisation of antibody detection kits for COVID-19 in India. In partnership with KARWA Ltd under the technology transfer from the Indian Council of Medical Research (ICMR). As part of this collaborative effort, Cipla will be responsible for the marketing and distribution of the SARS CoV-2-IgG antibody detection ELISA that will be manufactured by KARWA Ltd. ICMR has provided the requisite technological know-how and process for developing the test kits to the approved manufacturers. The product will be marketed under the brand name ‘ELIFast’. Cipla’s expansive distribution network will help in ensuring the seamless supply of kits across the country. Supply will be undertaken through the channels approved by ICMR, to ensure equitable access. IgG Antibody tests identify the immune status of the individuals to the COVID-19 infection. ICMR has recommended these tests for conducting sero-surveillance. Sero-surveillance may help in determining the burden of COVID-19 at the community level and monitor the trends in the transmission of SARS-CoV-2 infection. ELIfast has been validated and approved by ICMR and the National Institute of Virology (NIV), Pune. It is found to have specificity and sensitivity of 99.33 per cent and 92 per cent respectively. The kit is user friendly with a simple protocol with ready-to-use reagents and is compatible with common ELISA equipment. ]]> https://biospectrumindia.com/news/97/17483/tata-elxsi-opens-medical-device-engineering-centre.html https://biospectrumindia.com/news/97/17483/tata-elxsi-opens-medical-device-engineering-centre.html Wed, 28 Oct 2020 14:35:00 +0530 Tata Elxsi, based in Bengaluru, has announced the opening of a Global Engineering Centre (GEC) with Aesculap AG, a subsidiary of German firm B Braun, one of the world´s leading manufacturers of medical devices and pharmaceutical products and services. Tata Elxsi has been selected as the global engineering services partner by Aesculap. The GEC is part of a strategic multi-year engagement in the field of engineering services. The GEC serves as a platform of talent and expertise for product design & engineering, regulatory support and clinical evaluation services. This centre will be essential to accelerate innovation, drive the transformation and growth for Aesculap‘s medical business. Martin Schaeuble, Vice President Abdominal and Cardio-Thoracic Surgery, Aesculap commented on this announcement” Tata Elxsi has proven to be the right partner, bringing the right mix of technical expertise and programme management skills. Together with Tata Elxsi we are in the position to continue our innovation activities as well as adherence across Aesculap’s product portfolio." "We are elated to be selected as a strategic partner of Aesculap. It is an absolute honour for us to be part of this journey in supporting Aesculap through our Global Engineering Centre, bringing together integrated competencies in R&D and innovation, digital technologies, deep domain understanding of medical devices and ever-evolving regulatory standards. This further consolidates our position in the Medical Devices and Healthcare market in Europe, and strengthens our relationship with Aesculap and the B Braun group," said Nitin Pai, Chief Strategy Officer and CMO, Tata Elxsi. Tata Elxsi, global engineering services, Global Engineering Centre, Aesculap AG, B Braun, medical device engineering, ]]> https://biospectrumindia.com/news/97/17477/philips-unveils-breakthrough-ultrasound-3300-system-in-india.html https://biospectrumindia.com/news/97/17477/philips-unveils-breakthrough-ultrasound-3300-system-in-india.html Tue, 27 Oct 2020 15:05:00 +0530 Royal Philips has launched the Ultrasound 3300, a new innovative ultrasound series tailored for Obstetrics and Gynaecology (OBGYN), General Imaging and Cardiovascular Imaging procedures. Through this breakthrough technology, Philips offers clinicians and doctors in India a powerful combination of performance and workflow optimisation for quick and efficient diagnosis with low operating costs. The Ultrasound 3300, series is a versatile system and delivers exceptional image quality across a variety of clinical applications such as OBGYN, Cardiology and General Imaging. The system is ergonomically designed to ensure high patient throughput and enhanced user and patient comfort. Commenting of the launch of the product, Chhitiz Kumar, Business Leader, Precision Diagnosis and Connected Care, Philips Indian Subcontinent said, “The Ultrasound 3300 is the perfect system for start-up clinicians looking to set-up their first OBGYN centre or even as a second system in a well-established centre, to help manage their workloads. Engineered at the Philips Innovation Campus in Bengaluru, this system is also a testament to Philips’ focus on India as a strong and growing Ultrasound market.” The Ultrasound 3300, system delivers path-breaking features including Automatic Follicle Counting on 2D probes, which reduces cost for customers and improves throughput in clinic set-ups. Small private and public hospitals as well as private obstetrics and gynaecology clinics which are often challenged by a lack of funds, high waiting times, and space constraints will benefit from the capabilities of the Ultrasound 3300. The affordable system also comes equipped with Nuchal Translucency (NT) Assist feature, which automatically measures the thickness of the nuchal translucency during first trimester scans. This feature also helps in streamlining the workflow while helping to increase reliability of the measurement. The Ultrasound 3300, offers the Auto Ejection Fraction feature, increasing the diagnostic confidence for cardiologists. It also comes equipped with the largest-in-class 21.5-inch LED Monitor which provides enhanced image resolution and folds down for easy transportation. The state-of-the-art system also consists of advanced applications like contrast imaging and needle enhancement features. The new generation algorithm of the machine reduces speckle noise while enabling physicians to get natural and smooth images.   ]]> https://biospectrumindia.com/news/97/17476/indus-health-plus-brings-genomic-test-for-covid-19.html https://biospectrumindia.com/news/97/17476/indus-health-plus-brings-genomic-test-for-covid-19.html Tue, 27 Oct 2020 14:25:00 +0530 Indus Health Plus has launched COVIDNAwise, a revolutionary genomics test to know the predisposition of COVID-19. The test will inform genetic risks about 18 parameters under three categories – Susceptibility and Severity of COVID-19, Nutrition & COVID-19, and Co-morbidities of COVID-19. Scientists are coming up with new findings every few days elucidating the role of host genetic factors in response to this infection. Although there is still a lot to understand yet, there exist studies that show an association between different genetic polymorphisms and the risk of various COVID-19 related parameters. Based on this latest available knowledge, Indus Health Plus came up with this COVIDNAwise test. Amol Naikawadi, Joint Managing Director, Indus Health Plus, Pune said, “In times of COVID, it is critical that people understand the value of prevention and follow the proper guidelines as everyone is at risk of getting infected. However, the impact of infection may have a different response in individuals based on their genetic makeup or formation. Therefore, with our expertise in the field of genetics, we are unfolding a unique platform of prevention, COVIDNAwise in an endeavour to create a healthy future for people.” COVIDNAwise test will help in decoding the genetic makeup and informing an individual about their genetic susceptibility and genetic risk for severe complications associated with COVID-19 like respiratory failure etc. (severity) of COVID-19. Besides, it will enable the understanding of the genetic risk of deficiency of various nutrients that are immunity boosters and catalysers for good metabolism to fight the infection. Apart from that, it will also accentuate the comorbidities like diabetes, obesity, hypertension, etc. that can aggravate the severity of COVID-19 infection. COVIDNAwise is a saliva-based user-friendly genetic test that can be done from the comfort of home. Indus Health Plus has a strong network across the country that provides door – to – door sample collection service for consumers. The package is available pan India, at an affordable price and includes a saliva sample kit, reports, and counselling by a genetic counsellor. The test reports are comprehensive and consumer-friendly. Testing and reporting involve cutting edge technology and international standards.   ]]> https://biospectrumindia.com/news/97/17471/calicut-centre-for-surgery-partners-with-niramai-to-provide-contact-less-breast-cancer-screening.html https://biospectrumindia.com/news/97/17471/calicut-centre-for-surgery-partners-with-niramai-to-provide-contact-less-breast-cancer-screening.html Mon, 26 Oct 2020 18:40:00 +0530 Dr Ambadi’s Calicut Centre for Surgery (CCS) located at Metromed Hospital, Kerela has recently partnered with Bangalore-based NIRAMAI Health Analytix, India’s foremost AI-based breast cancer screening company, to offer contactless,  privacy-sensitive, breast cancer screening services to customers.   Niramai’s innovative solution called ‘Thermalytix’, is an automated breast health screening and diagnostic tool, which combines thermal imaging with artificial intelligence. The solution is non-contact, radiation-free, accurate, automated, and works on women of all age groups. Given that it is portable and low-cost than other methods, the solution makes cancer screening more accessible and affordable to all.    With this collaboration, women can also avail of home-screening services which will bring this novel non-touch breast cancer screening solution to the door-step of homes reducing the need to go to a hospital during the pandemic. Only female technicians will provide this service following all covid safety precautions and women can avail of this service with a prior appointment.   The test will be conducted in complete privacy without any physical contact. NIRAMAI Thermalytix test is appropriate for women of 18 years and above. It is privacy-aware, non-invasive, radiation-free, and can detect the minutest of lumps or other abnormalities.     ]]> https://biospectrumindia.com/news/97/17448/tuv-rheinland-opens-biomaterial-emc-testing-labs-at-amtz.html https://biospectrumindia.com/news/97/17448/tuv-rheinland-opens-biomaterial-emc-testing-labs-at-amtz.html Fri, 23 Oct 2020 12:35:00 +0530 TUV Rheinland has recently announced the opening of its Biomaterial and EMC (Electro Magnetic Compatibility) Testing Laboratories located at Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam, Andhra Pradesh. These newly opened laboratories, housed within the TUV Rheinland Medical Device Centre of Excellence have been accredited in accordance with International Standard ISO/IEC 17025:2017 for Medical, Non-Medical Devices and EMC Testing Services by the National Accreditation Board for Testing and Calibration Laboratories (NABL). The EMC Testing Laboratory has also been accredited by the American Association for Laboratory Accreditation (A2LA). At the Medical Device Centre of Excellence, TUV Rheinland offers customers an extensive list of services which includes Regulatory Compliance, Product Performance, Engineering Analysis and Reliability Services for various active and non-active medical devices such as Medical Ventilators, Face mask, X-ray Systems, Infant Care Devices, Health Monitoring Devices and Medical Implants.  TUV Rheinland's state-of-the-art Biomaterial Testing Laboratory is equipped to analyse and test the nature of biomaterial along with physiochemical, histopathological, and mechanical strength evaluation -both post and pre-implantation, sterility and other related tests. TUV Rheinland's Medical Device Centre of Excellence offers a fully equipped EMC testing facility as a one-stop-solution for all immunity tests as per medical and non-medical product categories. The laboratory has a wide range of environmental test facilities such as Combined Shock and Vibration as well as Thermal Shock Chambers to support manufacturers with their product validations. The A2LA accreditation for EMC Services helps to perform tests locally and is a full-service-solution for entry into international markets.    ]]> https://biospectrumindia.com/news/97/17449/icmr-achieves-milestone-of-conducting-10-cr-covid-19-tests.html https://biospectrumindia.com/news/97/17449/icmr-achieves-milestone-of-conducting-10-cr-covid-19-tests.html Fri, 23 Oct 2020 12:30:00 +0530 Indian Council of Medical Research [ICMR], the apex body at the forefront of formulating COVID-19 testing strategy in India has achieved the milestone of conducting 10 crore tests on October 22, 2020. With average testing of more than 10 lakh per day in the last 17 days. Till date 74000 tests per million population have been conducted. India has conducted the last five crore sample testing in only 45 days. As on September 8, 2020 India had tested five crore COVID-19 samples, and in less than 50 days it has reached 10 crore mark on October 22, 2020. This has been enabled by rapidly increasing testing infrastructure and capacity across the country. ICMR has been enhancing COVID-19 testing capability across the country by expanding and diversifying testing capacity by leveraging technology and facilitating innovation in affordable diagnostic kits. Prof (Dr) Balram Bhargava, Director General, ICMR said, “We have effectively responded to the evolving epidemic through focused and collaborative efforts of the Centre, State/UTs government. Exponential increase in testing has led to early identification, prompt isolation & effective treatment of COVID-19 cases along with effective contact tracing. These have eventually resulted in a sustained low fatality rate. This testing milestone is testimony to the fact that India has been successful in implementing strategy of 5T approach “Test, Track, Trace, Treat and use of Technology” efficiently, which will enable us to contain the spread of the pandemic.’’ Ramping up of testing facility across India was at the core of increased testing per day. Through our ardent efforts, it was ensured that a specific testing platform is made available addressing general testing (RT-PCR), High-throughput testing (COBAS), testing at remotest places and PHCs (TrueNAT, CBNAAT),in containment areas (rapid antigen testing) and for large number & migrant population testing (pooled sample testing). The total number of diagnostic laboratory has reached 1989. Of which dedicated government laboratories are 1122 and private laboratories number stands at 867.   ]]> https://biospectrumindia.com/news/97/17446/dr-dangs-lab-launches-bacteriophage-sensitivity-testing-in-india.html https://biospectrumindia.com/news/97/17446/dr-dangs-lab-launches-bacteriophage-sensitivity-testing-in-india.html Fri, 23 Oct 2020 00:00:00 +0530 Dr Dangs Lab and Vitalis Phage Therapy, India’s first phage therapy initiative, have recently joined hands to bring diagnostic bacteriophage sensitivity testing to India. This pioneering initiative will enable people suffering from bacterial infections to get bacteriophage susceptibility testing done locally in India, making it easier for them to access phage therapy offered by the Eliava Phage Therapy Center, associated with the 97-year-old Eliava Institute of Bacteriophages, Microbiology and Virology in Tbilisi, Georgia. Thousands of individuals worldwide have benefited from phage therapy over the past few years and over the last couple of years, Vitalis Phage Therapy has enabled dozens of patients from India with conditions such as chronic UTI, kidney infections, prostatitis, respiratory infections to benefit from phage therapy from the Eliava Phage Therapy Center. Bacteriophages, or simply phages, are viruses that are natural predators of bacteria. They are the most abundant organisms in the Earth’s biosphere and are present in every environment where bacteria are present – even inside the human body. Though phage therapy was first developed over a hundred years ago, the last century has mainly witnessed treatments for infections with antibiotics. Phage therapy is an alternative approach to treat bacterial infections & it can be used to treat antibiotic-resistant infections. Antibiotic resistance or antimicrobial resistance (AMR) due to rampant misuse of antibiotics, will eventually evolve to be a major threat to humanity. This novel initiative will increase accessibility to phage therapy as an extremely effective alternative for treatment of antibiotic-resistant infections. “We are very excited to provide Bacteriophage Susceptibility Testing at Dr. Dangs Lab for patients seeking phage treatment through Vitalis Phage Therapy. In line with the lab’s motto of, “Creating Value over Volumes” we are immensely hopeful of the power of Phage sensitivity testing and subsequent therapy to help the huge number of people suffering from unresolved bacterial infections.The cost of phage susceptibility testing will be Rs 850 & the services, for sample collection will be offered in all major cities pan India ”, says Dr. Arjun Dang, CEO, Dr. Dangs Lab, New Delhi. In order to administer phage therapy, it is necessary to first test the patient’s samples from the infected site to establish the sensitivity of the pathogenic bacteria to the phages, to know which phages will be effective in treating the infection. “In our experience of enabling phage treatment for patients, we realised that samples sent from India to Georgia for phage sensitivity testing would take up to 2 weeks to reach. This made phage therapy out of reach for patients suffering from acute infections, and we at Vitalis Phage Therapy were committed to help patients overcome this hurdle. With testing now available locally at Dr. Dangs Lab, patients will be able to get their culture and phage susceptibility report in a matter of days, making the diagnostic process quicker and more timely for their treatment”, says Pranav Johri, Founder of Vitalis Phage Therapy, the official partner of the Eliava Phage Therapy Center and Eliava Institute in India. “Local testing of clinical bacterial isolates on susceptibility to therapeutic bacteriophage preparations within a local diagnostic laboratory as opposed to sending the isolates to Georgia will significantly speed up the process of phage selection and subsequent phage treatment. Providing this activity locally thus will help medical staff accelerate their treatment of a patient battling bacterial infections,” writes Dr. Mzia Kutateladze, Director of the Eliava Institute.           ]]> https://biospectrumindia.com/news/97/17444/wipro-ge-healthcare-installs-ct-in-a-box-in-mumbai.html https://biospectrumindia.com/news/97/17444/wipro-ge-healthcare-installs-ct-in-a-box-in-mumbai.html Thu, 22 Oct 2020 17:00:00 +0530 Maharashtra has been one of the badly affected states in the country due to the ongoing COVID-19 pandemic with Mumbai being the epicentre. Leading the charge in the fight against the pandemic is Mumbai Metropolitan Region Development Authority (MMRDA) which has established the biggest COVID-19 centre at the Bandra-Kurla Complex (BKC) grounds. To augment the ongoing efforts, a consortium of three companies - PNB Housing Finance Ltd, Larsen & Toubro, SNC-Lavalin, as part of their Corporate Social Responsibility (CSR) efforts have joined hands to provide this ‘CT in a Box’ to this facility which is now handed over to Brihanmumbai Municipal Corporation (BMC). The ‘CT in a Box’ is a unique solution by Wipro GE Healthcare to diagnose and manage COVID-19 patients. This joint CSR effort was facilitated by NGO partner, United Way of Bengaluru. 'CT in a Box’ is Wipro GE Healthcare's turnkey innovative solution providing accelerated access to CT diagnostic solutions in situations requiring increased/isolated CT scans like the COVID-19 pandemic. This AERB (Atomic Energy Regulatory Board) approved solution has two parts: 1) A CT machine to diagnose and treat COVID-19 suspected patients; and 2) an insulated box which houses it. This box is specially designed and fabricated with safety features and aids in faster decontamination. The cabin further has separate entry and exit points for staff and patients ensuring almost no physical contact, minimising secondary infection. This ‘CT in a Box’ houses Wipro GE Healthcare’s RevolutionTM ACTs Ex, the country’s first ‘Made in India’ CT machine. With just 16 seconds for lung screening, advanced low dose protocols and emergency patient scan mode, this CT is well positioned to serve healthcare professionals and patients with fast and immediate results. The ‘CT in a Box’ is customizable with other GE Healthcare CTs as well. Shravan Subramanyam, Managing Director, Wipro GE Healthcare, South Asia said, “In line with the Prime Minister’s vision of an Atmanirbhar Bharat, Wipro GE Healthcare is proud to bring to the nation this state-of-the-art clinical solution for COVID-19 management.”     ]]> https://biospectrumindia.com/news/97/17433/iit-kgp-develops-ultra-low-cost-portable-device-for-covid-19-testing.html https://biospectrumindia.com/news/97/17433/iit-kgp-develops-ultra-low-cost-portable-device-for-covid-19-testing.html Wed, 21 Oct 2020 14:15:00 +0530 ‘COVIRAP,’ the diagnostic machine developed by IIT Kharagpur (Kgp) researchers, has been successfully validated for its efficacy in COVID-19 detection by the Indian Council of Medical Research (ICMR). Various commercial units have already approached the Institute for technology licensing to enable a rapid reach of this innovation to the common people. This new testing method implements a highly reliable and accurate molecular diagnostic procedure that can be conducted in an ultra-low-cost portable device unit developed by the IIT Kharagpur research team. The test results are rendered via a custom-made mobile application for dissemination without requiring manual interpretation. Dr Ramesh Pokhriyal Nishank, Minister of Education, GoI, said, “This innovation has made high-quality and accurate COVID testing affordable for the common people with a testing cost of around Rs 500/- which can further be reduced through government intervention. As informed by IIT Kharagpur, this machine can be developed at a cost of less than Rs 10,000/- with minimal infrastructural requirement making the technology affordable to common people. Elaborating on the validation process of ‘COVIRAP’ Diagnostic Test, Dr Mamta Chawla Sarkar, International Virologist who oversaw the patient trials on behalf of ICMR-National Institute of Cholera and Enteric Diseases (NICED) said, “A detailed scrutiny of the testing results has clearly shown that this assay holds the capability of detecting extremely low levels of viral loads that any other method based on similar principles of testing, even those from the most celebrated research groups across the world, could not come up with so far.” The novel diagnostic platform, developed by a team of researchers lead by Prof Suman Chakraborty, Professor, Department of Mechanical Engineering, IIT Kharagpur, and Dr Arindam Mondal, Assistant Professor, School of Bio-Science, IIT Kharagpur, has been subjected to rigorous testing protocols as per ICMR guidelines, at ICMR-NICED, an Institute authorised by ICMR. The tests conducted there have revealed that the results from this new assay are of standards comparable to the celebrated RT-PCR tests, with a remarkably high level of specificity and sensitivity, the two common parameters used as indicators of efficacy of any diagnostic test. ]]> https://biospectrumindia.com/news/97/17423/high-tech-cancer-treatment-solutions-ensure-effective-treatment.html https://biospectrumindia.com/news/97/17423/high-tech-cancer-treatment-solutions-ensure-effective-treatment.html Tue, 20 Oct 2020 14:55:00 +0530 Across the globe, cancer treatment techniques and tools have significantly improved over the past few years and India is also expanding its uptake of high-tech solutions for cancer treatment to ensure that people can access effective treatment, within the country, at affordable rates. October is the month dedicated to Breast Cancer Awareness. According to the Ministry of Health and Family Welfare, the incidence of breast cancer is 25.8 per 100,000 women and is expected to rise to 35 per 100,000 women in 2026. The very first step to successful cancer prognosis is to get it diagnosed before it is widely spread and life-threatening. With hospitals and technicians adopting early detection technologies, these are some of the flexible and affordable solutions that can enable efficient diagnosis and enable better treatment -   Mammography displays, which offer medical grade visualisation, allow flexible positioning of multiple images on the screen and are designed to facilitate optimal use of picture archive and communications systems (PACS) and efficient breast imaging. Mammography displays such as Barco’s Coronis Uniti Diagnostic Display offer high image quality, productivity features, and ergonomics to address specific challenges in modern radiology. Coronis Uniti’s USP lies in the fact that it supports 2-D and 3-D imaging, offering features to optimise reading experience. It features optical glass technology to reduce reflections and enhances image sharpness for greater viewing comfort. It can be turned into a virtual lightbox to compare film-based priors – using a handy film clip – with current digital exams, ensuring early and precise diagnosis. Breast Ultrasound Solutions detect additional early-stage, invasive breast cancers when combined with mammography. BreastNav, a breast ultrasound solution by Esaote, is designed on a model-adaptive algorithm and represents the real shape and morphology of the patient’s breast, on a virtual model. BreastNav environment can integrate other advanced technologies like microV, microE, ElaXto and QElaXto 2D to offer a complete analysis of breast lesions and provide 3D localization rendering. Digital breast tomosynthesis help doctors to easily detect breast cancers. Offered by GE Healthcare, the Seno Iris is a data-intensive technology that pushes the boundaries of viewing tools, enhancing the ability of doctors and technicians to efficiently and accurately diagnose patients. Seno Iris can help doctors in quickly and optimally exploring precise, detailed 3D images.   ]]> https://biospectrumindia.com/news/97/17413/rockefeller-foundation-awards-5-5m-grants-to-scale-upindias-covid-19testing.html https://biospectrumindia.com/news/97/17413/rockefeller-foundation-awards-5-5m-grants-to-scale-upindias-covid-19testing.html Mon, 19 Oct 2020 18:25:00 +0530 The Rockefeller Foundation has announced two new grants to The Centre for Cellular and Molecular Platforms and PATH. The grants, totalling $5.5 million, will support the domestic manufacturing of critical testing materials and the deployment of scalable testing programmes, essential to mitigating COVID-19. Additionally, the grants will advance efforts to leverage data and technology to strengthen pandemic surveillance and response.  “Expanding access to COVID-19 testing, especially among high-risk populations, is critical to safeguarding the health of Indians,” said Prof K VijayRaghavan, Principal Scientific Advisor to the Government of India. The Foundation’s new grants include:  The Centre for Cellular and Molecular Platforms (C-CAMP) is receiving funding to scale up the local manufacturing of reagents and testing solutions in India, providing the country with the elements needed to domestically produce reverse transcription polymerase chain reaction (RT-PCR) testing kits.  “RT-PCR tests remain the gold standard for confirming active COVID-19 infections,” said Dr Taslimarif Saiyed, CEO, Director C-CAMP. “By helping scale up domestic test production, this grant will strengthen India’s diagnostic capacities and improve its ability to mitigate the virus.” PATH has received a grant to expand Covid-19 testing capacity in Uttar Pradesh, Maharashtra and Punjab. With this funding, PATH will support state governments to develop and deploy optimised testing strategies that can be replicated and scaled up rapidly, seek to make COVID-19 screening and diagnostic tools available at an affordable cost, create an ecosystem of faster diagnosis of COVID-19 in key geographies, and establish pandemic surveillance models.   “The evolving nature of Covid-19 has highlighted the need for rapidly deployable testing strategies,” said Neeraj Jain, Country Director, PATH India. “By using this partnership to establish working models, we can help ensure more people have access to testing and provide public health officials with the information they need to keep their communities safe.”  “Scaling up COVID-19 testing provides crucial data insights that can help inform India’s response and direct targeted interventions to those most in need,” said Dr Naveen Rao, Senior Vice President, Health, The Rockefeller Foundation. ]]> https://biospectrumindia.com/news/97/17387/abbott-introduces-next-gen-heart-rhythm-management-devices-in-india.html https://biospectrumindia.com/news/97/17387/abbott-introduces-next-gen-heart-rhythm-management-devices-in-india.html Wed, 14 Oct 2020 00:00:00 +0530 Abbott has announced the launch of its new implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices, bringing the most advanced heart rhythm management capabilities along with a new set of benefits to people in India with abnormal heart rhythms and heart failure. The devices offer new opportunities for patient engagement and remote monitoring through smartphone connectivity and connected applications. Additional benefits include a patient preferred design, improved battery longevity and MRI compatibility. India was the only country outside the European Union where a "New Technology Assessment," which includes physician feedback surveys, for this new portfolio of high voltage (HV) and CRT-D devices took place. The first implant in India was conducted earlier in the year by Dr. Balbir Singh, Chairman & Head of Cardiology, Max Group of Hospitals, New Delhi.  "There is seamless connectivity between the device and the programmer. In fact, the first transmission made with the patient’s phone was completed within a few seconds," Dr. Balbir Singh said. "It’s really fast." In addition to enhanced remote monitoring capabilities, this CRT-D system includes multiple point pacing and optimization features to help more patients respond to CRT therapy. Also, the ICD device includes Abbott's tailored therapy suite to help physicians more intuitively program their patient's devices. By incorporating these features into the new systems, Abbott continues to prioritize therapy built around a patient's specific programming needs to ensure they respond to treatment in the most effective way. Abbott has designed these devices with a secure lifecycle approach, which includes using the latest cybersecurity controls and partnering with industry cybersecurity experts to provide input into the design and testing of these controls.  This approach provides the ability to more seamlessly update the device as cybersecurity threats evolve in the future. The design does not compromise on battery longevity or high voltage output. ]]> https://biospectrumindia.com/news/97/17370/thermo-fisher-expands-covid-19-test-portfolio-with-new-ab-tests.html https://biospectrumindia.com/news/97/17370/thermo-fisher-expands-covid-19-test-portfolio-with-new-ab-tests.html Mon, 12 Oct 2020 01:05:00 +0530 Thermo Fisher Scientific Inc. has introduced two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. These new tests for detecting COVID-19 antibodies expand the company's leading response to the pandemic, which ranges from molecular diagnostic tests and sample collection products, to personal protective equipment, to support of therapy and vaccine development and manufacturing. OmniPATH COVID-19 Total Antibody ELISA test The OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with the Mayo Clinic and WuXi Diagnostics as previously announced, has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG). EliA SARS-CoV-2-Sp1 IgG test The EliA SARS-CoV-2-Sp1 IgG test is commercially available in accordance with the FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)". The EUA is currently under review by the FDA. The EliA test is designed for automated processing of up to 60 results per hour on the Thermo Scientific Phadia 250 instrument. The EliA test is quantitative within markets that accept the CE mark and semi-quantitative in the U.S. Individual IgM and IgA EliA tests are also available now for research use only. Both of these new antibody tests are designed to meet the need for open ELISA and automated workflows. This flexibility enables laboratories to run the tests at customizable speed and throughput while using automated instruments already in place, minimizing initial costs and reducing the time needed to begin testing ]]> https://biospectrumindia.com/news/97/17237/biospectrum-ranking-issue-for-bioservices-coming-soon.html https://biospectrumindia.com/news/97/17237/biospectrum-ranking-issue-for-bioservices-coming-soon.html Fri, 09 Oct 2020 00:00:00 +0530 Amidst the pandemic, one more financial year concluded with lots of figures, calculations, positives and negatives, all related to finance and money, telling us where exactly the organisation stands today compared to the previous years. Everybody is interested in knowing the organisation’s performance – independent as well as compared to others in the sector. To highlight the achievements of the Bioservices sector in India, BioSpectrum is planning the ranking special issue in December 2020. Companies will be ranked on the basis of their revenues and other achievements that took place in the last financial year FY19-20.   The last date for application is 20 October. Click below to fill the form- https://www.biospectrumindia.com/ranking-survey-bioservices ]]> https://biospectrumindia.com/news/97/17353/medtronic-unveils-indias-first-pacemaker-that-syncs-with-smartphones.html https://biospectrumindia.com/news/97/17353/medtronic-unveils-indias-first-pacemaker-that-syncs-with-smartphones.html Thu, 08 Oct 2020 00:00:00 +0530 India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc, has announced the launch of the Azure™ pacemaker with BlueSync™ technology – India’s first and only pacemaker that can communicate directly with patients’ smartphones and tablets. The latest addition to Medtronic’s Cardiac Rhythm & Heart Failure portfolio in India, Azure is designed to accurately detect and reduce the likelihood of atrial fibrillation. It offers improved longevity (up to 13.7 years), so patients potentially need fewer device replacements and allows patients to have MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines. Azure features Medtronic-exclusive BlueSync technology, which enables automatic, secure wireless communication via Bluetooth Low Energy and remote monitoring via the Medtronic CareLink™ Network, providing more timely alerts of clinically relevant patient events that can be reviewed by a clinician at any time. Security controls implemented and validated on BlueSync enabled devices include access restrictions to protect integrity of device functionality and end-to end encryption to protect patient data. Atrial fibrillation (AF) is an irregular, rapid heart rate that may cause symptoms like heart palpitations, fatigue, and shortness of breath. AF occurs when the upper chambers of the heart (atria) beat out of rhythm. As a result, blood is not pumped efficiently to the rest of the body, causing an unusually fast heart rate, quivering, or thumping sensations in the heart. “The launch of Azure, our most advanced pacemaker, is testament to our commitment toward re-imagining innovation and delivering improved outcomes while reducing the burden on healthcare systems. The pacemaker communicates directly and securely with the MyCareLink Heart™ mobile app - an important advancement in the ongoing quest to constantly monitor patient condition remotely. Remote monitoring of heart conditions allows patients to receive expert medical advice from their physician while at home or traveling instead of making multiple trips to the hospital. It is a boon for heart patients and caregivers, especially in situations such as the COVID-19 pandemic, providing peace of mind and freedom,” said Madan Krishnan, Vice President, India Medtronic Pvt Ltd and Minimally Invasive Therapies Group APAC. ]]> https://biospectrumindia.com/news/97/17318/syngene-joins-global-consortium-to-accelerate-research-in-covid-19-testing.html https://biospectrumindia.com/news/97/17318/syngene-joins-global-consortium-to-accelerate-research-in-covid-19-testing.html Fri, 02 Oct 2020 00:00:00 +0530 Syngene International Limited has announced that it has joined a global consortium of 19 organizations from the healthcare industry, led by Bristol Myers Squibb, to help inform, improve and accelerate various aspects of COVID-19 testing, ranging from research to clinical diagnostic applications. The consortium brings together a diverse group of companies with synergistic areas of expertise, including precision medicine, diagnostics, occupational health, pharmaceuticals and clinical testing laboratories, to help provide clarity and potential solutions to COVID-19 testing challenges. To advance the goals of the consortium, members may: Share relevant expertise, materials and experiences to accelerate understanding of COVID-19. Analyze available scientific and health data, materials and information to develop, improve and deploy current assays and new approaches for the COVID-19 testing paradigm. Contribute knowledge gained from the collaborative research by publishing work that will inform the scientific community and general public of the consortium’s findings. Mahesh Bhalgat, COO Syngene, said, “Bristol Myers Squibb and Syngene have been research partners for fifteen years. We fully support the aims of the consortium and look forward to sharing our experience and expertise from the last six months including conducting testing of our staff, producing proteins, antibodies and oligonucleotides for diagnostic kits, and operating one of the largest RT-PCR testing private laboratories in Karnataka. The world of medical science is benefitting enormously by sharing information about this coronavirus and we welcome the opportunity to contribute.” Since the outbreak of the coronavirus pandemic, Syngene has been actively contributing its scientific expertise and resources in the fight against the virus. It has developed high-quality, mammalian-derived viral proteins such as S1, RBD, and N protein meant for diagnostic testing and assays. Its S1 protein was recently approved by ICMR for use in the ELISA testing kit being manufactured by HiMedia. The Company has also developed proprietary tool antibodies (monoclonal and polyclonal) with high affinity and specificity, for use in viral antigen detection and other such tests. It has collaborated with the Centre for Cellular & Molecular Biology (CCMB) to deliver a high throughput Next Generation Sequencing (NGS) based genomic screening assay that can test 5,000-10,000 samples simultaneously. It has also tied-up with Mylab Discovery Services for manufacture and supply of oligonucleotides (primers and probes) for use in their diagnostic kit. Syngene’s RT-PCR testing centre has conducted more than 50000 tests and has tied up with over 50 organisations for testing their employees. ]]> https://biospectrumindia.com/news/97/17312/icmr-approves-trivitrons-biocard-pro-covid-19-rapid-ag-test.html https://biospectrumindia.com/news/97/17312/icmr-approves-trivitrons-biocard-pro-covid-19-rapid-ag-test.html Thu, 01 Oct 2020 00:00:00 +0530 The Indian Council of Medical Research (ICMR) has granted its approval to Chennai based Trivitron Healthcare to commercially launch their flagship product COVID-19 Rapid Testing Antigen (ag) Kit. This Covid-19 testing kits will be branded as ‘Biocard Pro COVID-19 Rapid Antigen’ and is claimed to provide accurate results in just 7~10 minutes. Individuals suspected to have been infected with the novel coronavirus (nCoV) can make use of the Biocard Pro COVID-19 Rapid Antigen kit to confirm their infection status. Biocard Pro COVID-19 Rapid Antigen kit is a chromatographic immunoassay for the qualitative detection of COVID-19 specific antigen present in human nasopharyngeal. Using a nasal swab to get a fluid sample, antigen tests can produce results in minutes. As these tests are faster and less expensive than other popularly done PCR tests, antigen tests may be more practical to use for large numbers of people. Technical Specification of Biocard Pro COVID-19 Rapid Ag test kit: Method: Immuno chromatography Sample type: Nasopharyngeal Swab Assay Time: 7 to 10 minutes Storage: 4 to 30◦C Shelf-life: 24 months Rajesh Patel, Chief Executive Officer – IVD India, Trivitron Healthcare, on this occasion said - The main focus is to contribute in the global fight against COVID-19 through world class products and expertise in medical technology. Our Rapid antigen test is quicker than the available RT‑PCR based tests, as it takes approximately 7-10 minutes, compared to about five hours being taken by the RT-PCR based testing methods. Also, confirmation through antigen based tests does not require a sophisticated laboratory, which is a key requirement for RT-PCR tests. Biocard Pro COVID-19 Rapid Antigen kit will be manufactured at Trivitron’s Chennai manufacturing facility at the rate of around 4.5-5 million tests per month. The company plans to distribute these kits to various government entities and private laboratories through various marketing channels.  ]]> https://biospectrumindia.com/news/97/17300/terumo-india-introduces-phygital-model-to-advance-medical-skills.html https://biospectrumindia.com/news/97/17300/terumo-india-introduces-phygital-model-to-advance-medical-skills.html Wed, 30 Sep 2020 01:05:00 +0530 Terumo India, the Indian arm of Terumo Corporation, a global leader in medical technology headquartered in Japan, has announced the launch of eTISL, a ‘phygital’ version of its highly successful initiative, Terumo India Skill Lab (TISL). Designed as a hybrid of physical and digital interfaces, eTISL aims to accelerate medical education for cardiovascular healthcare professionals (HCPs) in India.  Coinciding with Terumo Corporation entering its hundredth year since inception, eTISL builds on the successful journey of the Terumo India Skill Lab and is a fitting tribute to an organization whose starting point and unchanging corporate mission has been ‘Contributing to Society through Healthcare.’   Over the past two years, TISL has delivered high quality programmes to over 7000 healthcare professionals (HCPs) through 175 faculty, on diverse topics pertaining to cardiovascular health. Now, the shift to a ‘phygital’ model will allow the initiative to exponentially increase its reach and impact. The eTISL project is designed to include live events, digital colloquium and patient resources covering various topics such as safer cardiovascular procedures, bifurcation, multiple vessel disease, complex PCI, trans-radial intervention, complex CTO and perfusion technology. ]]> https://biospectrumindia.com/news/97/17284/iisc-develops-rapid-covid-19-rt-pcr-kit.html https://biospectrumindia.com/news/97/17284/iisc-develops-rapid-covid-19-rt-pcr-kit.html Mon, 28 Sep 2020 00:00:00 +0530 Equine Biotech, a social entrepreneurial initiative by Prof. Utpal Tatu, Department of Biochemistry, Indian Institute of Science (IISc), Bengaluru has engineered and developed a sensitive, rapid, and affordable COVID-19 diagnostic kit that is approved by Indian Council of Medical Research (ICMR). Prof. Utpal Tatu’s Lab at IISc, with over 23 years of experience in studying infectious diseases, has a social entrepreneurial initiative called Equine Biotech. This start-up, recognised by the Government of Karnataka and Government of India, is involved in developing diagnostics for emerging infectious diseases such as COVID-19. The company has now developed a COVID-19 RT-PCR diagnositic kit called “GlobalTM diagnostic kit” for accurate and affordable diagnosis. Equine Biotech is looking to licence the above kit for large scale manufacturing and sale. The agreement would involve tech transfer and support in manufacturing of kits. "We are looking at Med-Tech companies with experience in distribution and marketing of diagnostic kits", said Prof Tatu. ]]> https://biospectrumindia.com/news/97/17269/indian-healthcare-leaders-congregate-at-first-ever-hybrid-global-conference.html https://biospectrumindia.com/news/97/17269/indian-healthcare-leaders-congregate-at-first-ever-hybrid-global-conference.html Fri, 25 Sep 2020 01:05:00 +0530 The Asia Pacific Medical Technology Association (APACMed) in Singapore brought to fruition the first-ever hybrid virtual forum – Redefining Healthcare Agility, which welcomed more than 130 world class leaders from over 30 countries to share insights on how they are transforming the healthcare industry. The forum involved a plethora of interactive engagements, including live discussions, interviews and demonstrations. The APACMed Annual MedTech Forum brings more than 1,000 delegates together every year, making it one of the largest yearly forums in Asia Pacific. Owing to the pandemic, the 6th edition of the conference included on-site attendance of up to 50 people, along with virtual attendance of over 1000 delegates, thus becoming the first ever hybrid conference with a global reach to be hosted in the medical technology arena. The conference witnessed the participation of global and regional leaders, serving as the perfect setting for discussing collaboration and innovation opportunities in Asia. The Regional Insights Session kicked off with the release of the much awaited APACMed- McKinsey Business Sentiment Survey, which gives insights from senior MedTech leaders surveyed from a range of different product sectors, business scales and geographies on the current market trends and overall business sentiment. Few of the key trends which emerged from the survey included Continued momentum exists for local manufacturing in Asia including India, with 60% of the leaders believing the trend of localization of manufacturing capability will increase going forward Leaders indicate digitalization, local product innovation, and market access as the most important growth drivers with key capability gaps in digitalization and locally relevant product innovation. Digital transformation has been a favourite topic, but without much improvement over the years. Revenue growth expectation was high at the beginning of the year, with an expected CAGR of 12%, which after COVID-19 has dramatically reduced to about 7%. In India 60% companies surveyed found product innovation or cutting-edge premium products to be their real strength. Nearly 100% found serving premium markets to be their real strengths, and 60% realized providing HCP training to expand market as their real strength Within the regional insights track as part of focus country this year, India have been featured through an exclusive Healthcare Leaders session under the title “Leapfrogging Towards Healthcare 4.0” , where the panel comprised of leaders from entire healthcare value chain including Hospitals, MedTech & Diagnostics, and discussions revolved around how digital transformation is driving access and affordability in healthcare, especially from a post COVID scenario. The panelists included – Manoj Madhavan, Managing Director, Boston Scientific India Badhri Iyengar, Cluster Managing Director - (SAARC & ASEAN); Smith & Nephew Anish Bafna, Chief Executive Officer & Managing Director, Healthium Pavan Choudary, Chief Executive Officer & Managing Director, Vygon India Himanshu Baid, Managing Director, Poly Medicure K. Hari Prasad M.D, Group President – Hospitals, Apollo Hospitals Enterprise Dr Om Manchanda, Managing Director, Dr Lal PathLabs Dr Chirag Adatia, Partner, McKinsey & Company (Moderator) ]]> https://biospectrumindia.com/news/97/17262/alivecor-enters-india-with-unique-ecg-device.html https://biospectrumindia.com/news/97/17262/alivecor-enters-india-with-unique-ecg-device.html Thu, 24 Sep 2020 02:10:00 +0530 AliveCor, the global leader in US FDA-cleared personal electrocardiogram (ECG) technology, has announced its entry in the Indian market with the revolutionary launch of the most clinically-validated personal ECG device, KardiaMobile 6L. Owing to the accessibility challenges to quality healthcare in the country and COVID related infection fears, the portable and technology-enabled ECG device will help deliver affordable and convenient heart care to over 260 million heart patients and those at risk, without visiting a hospital. KardiaMobile 6L is the only personal ECG device in the world that can detect the three most common arrhythmias or irregular heartbeat—atrial fibrillation (AFib), bradycardia, and tachycardia, which require regular monitoring and a healthy lifestyle. US based AliveCor’s innovative technology gives patients the ability to record a medical-grade ECG in just 30 seconds, with no hospital visits and complete peace of mind. The device is small enough to fit in a pocket, allowing users to check in on their heart anytime, anywhere right from their smartphone. In a country like India where over 70% of the population owns a smartphone, this technology comes as a big boost to make heart care accessible, affordable and convenient. AliveCor’s entry into India comes at an opportune time when the public is cautioned to stay at home and the condition of most patients suffering from heart abnormalities has been worsening. While infection scare at hospitals is hampering regular check-ups, KardiaMobile 6L gives consumers the ability to keep track of their heart health from the comfort of home. The pocket-sized, portable device enables clinicians to manage patients remotely. Considering the ongoing health crisis, use of KardiaMobile 6L reassures optimal clinical control and caters to the need for efficient tools for safe out-of-hospital management. For patients with pre-existing conditions or those who feel a symptom, it provides convenience to track heart health on-the-go without hospital visits. AliveCor’s KardiaMobile 6L is priced at Rs 14000 and KardiaMobile is priced at Rs 8500.  ]]> https://biospectrumindia.com/news/97/17260/hcg-strand-ls-broaden-patient-access-to-genomic-testing.html https://biospectrumindia.com/news/97/17260/hcg-strand-ls-broaden-patient-access-to-genomic-testing.html Thu, 24 Sep 2020 00:00:00 +0530 Bengaluru based HealthCare Global Enterprises Limited (HCG Cancer Hospital Bengaluru) and Strand Life Sciences has recently launched comprehensive genomic profiling (CGP), an approach to detect multiple actionable cancer biomarkers at ‘one go’ to optimize treatment for better clinical outcomes. HCG has joined hands with Strand to develop StrandAdvantage500, a simple and comprehensive Next Generation Sequencing (NGS) based assay that analyses cancer-relevant genetic alterations from DNA and RNA derived from a patient’s tumor in one integrated workflow. Speaking about the launch, Dr. B.S. Ajaikumar, Chairman and CEO, HCG Enterprises Ltd., said, “Cancer cases in India are on the rise, and the goal is to offer affordable as well as right cancer care.   We have witnessed instances where patients do not respond to certain drugs due to their heterogeneous genetic makeup. Partnering with Strand and Illumina, we have been diligently profiling our patients to understand their genomic makeup and manage them accordingly. However, with CGP based tumor profiling, we will have consolidated cancer-relevant biomarker detection to understand more actionable genetic alterations upfront.” Comprehensive genomic profiling with StrandAdvantage500 will overcome the challenge of iterative testing with limited biopsy samples and enable us to consolidate the detection of biomarkers into a single assay, thus saving precious biopsy samples, reducing the need of rebiopsy and provides faster and comprehensive results. This innovative approach will help in managing the disease better and design treatment with best possible clinical outcomes. ]]> https://biospectrumindia.com/news/97/17250/kerala-to-house-first-medical-devices-park.html https://biospectrumindia.com/news/97/17250/kerala-to-house-first-medical-devices-park.html Tue, 22 Sep 2020 01:05:00 +0530 Kerala will soon house one of the first medical device parks in the country, focusing on the high-risk medical device sector to provide full range of services for the medical devices industry like R&D support, testing, and evaluation.  MedSpark, the medical devices park envisaged as a joint initiative of Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), an autonomous institute of the Department of Science and Technology (DST), Govt. of India, and the Kerala State Industrial Development Corporation Ltd (KSIDC), the industrial and investment promotion agency of the Government of Kerala is going to be established in the Life Science Park, Thonnakkal, Thiruvananthapuram. This medical device park will stand out with its emphasis on the high-risk medical device sector involving medical implants and extracorporeal devices, in which SCTIMST scores with its knowledge. Currently, Kerala has a number of medical device companies with an annual turnover in excess of Rs. 750 crores, most of them operating with technologies transferred from SCTIMST.  When completed, the MedSpark will have: A Medical Device Testing & Evaluation Centre accredited to international agencies An R&D Resource Centre for facilitating R&D in medical device domain, the services of which would be shared by the entities within the Park A centralised Knowledge Centre for skill up-gradation with facilities for conducting training and providing support on regulatory issues, clinical trials, etc. A Technology Business Incubation Centre for promoting start-ups and early-stage companies A set of Modular Manufacturing Units for lease by the industries coming to the park or land modules for setting up manufacturing units The business model for the MedSpark is self-sustaining in which its operational expenses will be generated from its revenue streams. Funding from the state and central governments (both Kerala State and Central) through various schemes will meet the capital expenditure and deficit in income against expenses during the initial stages It is expected that the project would provide direct employment to 1200 people. Besides, employment generation up to 4000 – 5000 jobs through the supporting industries like OEM suppliers, service providers, and marketing/post marketing support activities ]]> https://biospectrumindia.com/news/97/17244/medall-diagnostics-steps-into-bengaluru-for-covid-19-testing.html https://biospectrumindia.com/news/97/17244/medall-diagnostics-steps-into-bengaluru-for-covid-19-testing.html Mon, 21 Sep 2020 17:15:00 +0530 Chennai based Medall Diagnostics has recently announced the receipt of approval from ICMR for conducting the COVID-19 tests at its Bengaluru facility.   Medall lab, with NABL accreditation, has the capacity to conduct 1500 tests per day in Bengaluru. Currently, this facility is available at its Sadashivnagar and Jayanagar centers. In the interest of the safety of patients, Medall will also be offering a home collection facility of samples.  Arjun Ananth, CEO, Medall Healthcare Private Limited said, “As the virus continues to spread globally, State Governments have put in place various measures to control the further spread of the pandemic. With 2 lakh cases and rising by the day, the approval from ICMR for COVID-19 testing in Bengaluru has come in at the right time reinforcing our commitment to offering qualitative diagnostic and healthcare services.”   Medall offers COVID Monitoring tests including D-Dimer, Ferritin, IL-6 and Screening tests including RT-PCR, Antibody and Antigen and HRCT chest with CT severity score and CORADS staging. As per the guidelines issued by ICMR for Covid-19 testing in private laboratories, Medall will provide the test adhering to the sample collection and testing guidelines set by ICMR.  ]]> https://biospectrumindia.com/news/97/17228/sctimst-inks-mou-with-tynor-orthotic-to-boost-orthotic-devices.html https://biospectrumindia.com/news/97/17228/sctimst-inks-mou-with-tynor-orthotic-to-boost-orthotic-devices.html Fri, 18 Sep 2020 00:00:00 +0530 Development of orthotic devices may soon receive a boost with a Kerala based scientific institution collaborating with a Mohali based private manufacturer for co-development of such devices catering to clinical conditions such as osteoarthritis and diabetic foot ulcer. Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala (SCTIMST), an Institute of National Importance under the Department of Science and Technology, Government of India, has signed an MoU with Tynor Orthotics Private Limited (Tynor), Mohali, to set up an Orthotics and Rehabilitation R&D vertical to promote indigenous device development in this sector towards the goal of ‘Aatmanirbhar Bharat’, a high priority target of the Govt of India. Tynor, a manufacturer and exporter of high quality and affordable orthopedic appliances and fracture aids in India, will collaborate with SCTIMST for the co-development of Orthotic devices and to promote joint research programs in Orthotics and Rehab. Tynor has funded SCTIMST for Research and Development of two off-loading devices in patients with diabetic foot ulcers and osteoarthritis. The project is planned for one year with Tynor contributing Rs 27 lakhs to the program. The main objective of this Institute-Industry collaboration is to develop a cluster of orthoses for catering to clinical conditions such as osteoarthritis and diabetic foot ulcer.  SCTIMST has done considerable amount of R&D work in biomedical devices over the last 30 or more years and has established itself as a pioneer in this field. This collaboration with an Industry leader for co-development of ortho-rehab devices in the country is a commendable step. Tynor has planned to set up India’s first R&D Center in Orthopedic Appliances, Fracture Aids, Walking Aids, Compression Garments, and Footcare Products. This center has been named TORNADO (Tynor Ortho Research N Appliance Development Organization) and aims to bring about technology and innovation-based disruption at the scale of a tornado. This will be a novel center in which a Cross-Functional Team consisting of experts from Engineering, Orthopedics, Biomedical Sciences, Design shall be brought together to brainstorm and develop products as per the requirements of the Indian patient. Industry-academia collaboration is the key to achieve this feat. ]]> https://biospectrumindia.com/news/97/17225/ricovr-iit-m-receive-recognition-for-covid-19-diagnostic-device.html https://biospectrumindia.com/news/97/17225/ricovr-iit-m-receive-recognition-for-covid-19-diagnostic-device.html Thu, 17 Sep 2020 01:05:00 +0530 RICOVR Healthcare Inc., an US-based rapid diagnostics platform company and IIT Madras have developed a revolutionary point-of-care COVID-19 antigen test that can provide results in five minutes using saliva. This project won the prestigious ‘Ignition Grants’ Award from the U.S. India Science and Technology Endowment Fund (USISTEF). USISTEF, a joint fund established by the U.S. and India to promote innovation through science and technology, announced the results recently after a rigorous binational review process of over 400 proposals, The Ricovr-IIT Madras team was selected for its out-of-the-box, innovative idea to address the COVID-19 challenge. RICOVR Healthcare’s patented biosensor platform uses a small drop of saliva to provide high-quality, cost-effective results in approximately five minutes. IIT Madras is collaborating with RICOVR to bring this novel COVID-19 antigen test to the market. The innovative approach of detection and simple use of saliva will help bring a cost-effective, accurate, and user-friendly device to global markets in need of more immediate diagnostic tools. The RICOVR and IIT Madras collaboration is intended to support a successful joint U.S.-India entrepreneurial initiative devoted to battle COVID-19. It focuses on developing and implementing new technologies and systems to satisfy unmet rapid and reliable testing needs. RICOVR Healthcare is one step closer to bringing the Point-of-care Fiber-optic Biosensor (P-FAB) Device from the lab to the market. The USISTEF had called for proposals under the category of ‘COVID-19 Ignition Grants’ in April 2020. The intent was to support promising joint U.S.-India entrepreneurial initiatives that address the development and implementation of new technologies, tools, and systems to address COVID-19 related challenges, including monitoring, diagnosis, health and safety, public outreach, information, and communications. ]]> https://biospectrumindia.com/news/97/17213/wadhwani-institute-makes-ai-tool-to-screen-cough-based-covid-19.html https://biospectrumindia.com/news/97/17213/wadhwani-institute-makes-ai-tool-to-screen-cough-based-covid-19.html Wed, 16 Sep 2020 00:00:00 +0530 The Wadhwani Institute for Artificial Intelligence in Mumbai has announced that it has secured a US patent for its AI based tool "Cough against Covid". The tool can effectively screen for COVID-19 based on cough sounds. In what could be a real breakthrough for more efficient, effective COVID-19 testing, the AI tool can even identify asymptomatic individuals – those who have the infection but without a cough or any obvious symptoms. The results are instantaneous and the tool works on a basic smartphone. It does not require an app, special device or trained personnel. Commenting on this breakthrough, Dr. Rahul Panicker, Chief Research and Innovation Officer, Wadhwani Institute for Artificial Intelligence, said, "Testing for COVID-19 has been a major challenge since the start of the pandemic. This prompted us to think about how we could use AI to develop a non-invasive COVID-19 testing tool that was affordable and accessible to a large population. After months of hard work, we are proud to present our patented Cough against Covid AI tool that can identify both symptomatic and asymptomatic individuals. We believe it will help health care and civic authorities speed up testing and also focus their resources better, by filtering out patients with Covid-19 - like symptoms but without the infection. We will continue to work towards making it accessible to those who need it most. We also plan to share our research widely so that people around the world can benefit from the tool." Having achieved a balance between high sensitivity and low specificity, Wadhwani’s AI tool can be used as a COVID-19 triaging tool. It is expected that the tool can increase the testing capacity of a healthcare system by 43% without additional supplies, trained personnel, or physical infrastructure (at assumed disease prevalence of 5%).  ]]> https://biospectrumindia.com/news/97/17207/smt-unveils-hydra-tavr-device-in-central-europe.html https://biospectrumindia.com/news/97/17207/smt-unveils-hydra-tavr-device-in-central-europe.html Tue, 15 Sep 2020 00:00:00 +0530 SMT (Sahajanand Medical Technology Pvt Ltd), a global medical device company based in Mumbai, has launched the Hydra TAVR device in Central Europe. Internationally renowned interventional cardiologists Prof. Marek Grygier and Prof. Maciej Lesiak deployed HYDRA successfully at Poland’s Szpital Kliniczny Przemienienia Pańskiego centre. Transcatheter Aortic Valve Replacement (TAVR) is an established treatment modality for patients who are at a high risk or unwilling to undergo open heart valve replacement surgery. The Hydra aortic valve is a self-expandable nitinol based supra annular aortic system with a mechanism for recapturing of the valve during deployment. This technology allows for precise placement of the valve and also ensures orthotopic deployment. Speaking about the successful launch, Marek Kurysz, Country Head of SMT Poland said, “This is a significant step forward for SMT in Central Europe. Structural Heart is really a team effort, thanks to Prof. Grygier and Prof. Lesiak for their trust, Prof. Lars Sondergaard, Dr. Ole DeBacker for their first class proctoring and the TAVI Research Centre (TRC) in Surat for their world class clinical back end support." ]]> https://biospectrumindia.com/news/97/17182/cyient-agappe-take-diagnostic-capabilities-to-rural-india.html https://biospectrumindia.com/news/97/17182/cyient-agappe-take-diagnostic-capabilities-to-rural-india.html Thu, 10 Sep 2020 00:00:00 +0530 Cyient, a global engineering and digital technology solutions company, has announced that it has entered into a manufacturing partnership with Cochin based Agappe to bring to market Count X. The Mispa Count X is an indigenously designed and developed three-part hematology analyzer by Agappe, that will make India self-reliant in hematology and enable the setup of well-equipped labs in remote and rural locations across India. Cyient will manufacture certain key components of Mispa Count X at its ISO 13485-certified, state-of-art manufacturing facilities in India. Rajendra Velagapudi, Senior Vice President and CEO, Cyient DLM, commented, “We are proud to support the vision of an Atmanirbhar Bharat (self-reliant India) in the healthcare sector. It is a matter of immense pride that with Agappe’s new hematology product, even rural India and other remote locations of the country will have access to the best of diagnostic capabilities.” Hyderabad based Cyient’s world-class facilities, project management, sourcing, supply chain management, production processes, buoyed by investments in the latest technologies as well as expertise in the delivery of quality products, make it a preferred manufacturing partner for aerospace, defense, medical, and industrial customers globally. Dr. Satheesh Kumar CS, Senior Vice President, Agappe, said, “This partnership will enable Agappe to deliver high-quality, affordable, 100% made-in-India products by taking advantage of Cyient’s ultra-modern manufacturing facilities to manufacture some of the key components of Mispa Count X so as to reduce time-to-market and lower operating costs. We are eager to get started with full-scale production in our manufacturing facility at Cochin and fulfill customer orders on time.” ]]> https://biospectrumindia.com/news/97/17180/nathealth-apacmed-partner-for-harnessing-med-tech-in-india.html https://biospectrumindia.com/news/97/17180/nathealth-apacmed-partner-for-harnessing-med-tech-in-india.html Wed, 09 Sep 2020 17:25:00 +0530 NATHEALTH- Healthcare Federation of India, renowned as the credible voice of the health sector of India and the Asia Pacific Medical Technology Association (APACMed), the regional association of medical technology in the Asia Pacific recently signed a Memorandum of Understanding (MoU) to harness the role of the medical technology industry in India, in relation to AB-PMJAY and to ensure that it optimally engages with relevant policymakers, helping shape policies leading to achieving Universal Health Coverage (UHC) in India. The goal of this strategic partnership is to enable a seamless pathway that streamlines all innovations ensuring that it scales and increases the concerted efforts by both organizations. Both NATHEALTH and APACMed would work through a joint working group in formulating a work plan in relation to Universal Healthcare in India, that would synergize and complement the efforts of the government to maximize patient health outcomes through quality care relative to expenditures. In India, the government schemes such as Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) and Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana have helped India take bold steps towards UHC. The MoU and partnership between NATHEALTH and APACMeD will work to increase access to innovative medical technologies, which will lead to high quality and affordable healthcare delivery and complement the efforts of the Government’s UHC agenda. ]]> https://biospectrumindia.com/news/97/17174/medtronic-unveils-curved-jaw-cordless-ultrasonic-dissection-system-in-india.html https://biospectrumindia.com/news/97/17174/medtronic-unveils-curved-jaw-cordless-ultrasonic-dissection-system-in-india.html Wed, 09 Sep 2020 11:10:00 +0530 India Medtronic Private Limited, a wholly-owned subsidiary of Medtronic plc, has announced the launch of the Sonicision™ curved jaw cordless ultrasonic dissection system, which is a next-generation ultrasonic dissection device that delivers the combined benefits of enhanced precision to surgeons with convenience and safety in the operating room.   Sonicision Curved Jaw Cordless Ultrasonic Dissection System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open and endoscopic procedures. Access to the optimal device that is safe and allows for good precision and visibility for reaching tight spaces in the patient’s body is critical for surgeons while conducting these procedures in the operating room.   The new sonicision curved jaw system is a cordless device that improves movement, mobility, and safety in OR. The device has a single button with dual-mode energy control which allows access to a minimum and maximum energy modes so the surgeon’s eyes can stay on the surgical field and the tapered curved jaw provides access in tight spaces. All the features have been incorporated to empower surgeons to improve focus on the patient and the surgery at hand. ]]> https://biospectrumindia.com/news/97/17175/siro-clinpharma-and-azidus-to-expand-services-and-market-share.html https://biospectrumindia.com/news/97/17175/siro-clinpharma-and-azidus-to-expand-services-and-market-share.html Wed, 09 Sep 2020 00:00:00 +0530 SIRO Clinpharm Private Limited, India’s earliest clinical research organization partners with Chennai based Azidus, a full-service clinical research organization, to strategically expand combined services offerings and avail access to an expanded client base for technical requisites of pharmaceutical and biotechnology industries. Thane based SIRO focuses on patient studies and support trials from Phase II to Phase IV, while Azidus is focused on healthy volunteer studies, bringing synergies to the collaboration. This partnership will help SIRO to expand its product range and get exclusive access to a larger pool of clients in potential geographies of Asia and Latin America, where Azidus has a strong base.  Commenting on the partnership, Akshay Daftary, Director in SIRO Clinpharm and in-charge of Global Business Development Activities and Client Management said, “The synergies of the service offerings of SIRO with Azidus are driven by a common belief in quality; the strategic alliance will serve a strong growth driver for both organizations. This is a complementary alliance which will give the clients single-window end-to-end solutions, with accrued cost benefits. This collaboration resonates strongly with the project growth initiative that we follow as SIRO’s vision. The alliance would definitely boost SIRO’s presence across geographies like Brazil in Latin America and the USA.” Arjun Arumugam Olaganathan, Director, Azidus, said, “This strategic partnership with SIRO will help both organizations grow and expand their offerings. I see the potential of deeper market penetration and wider service contribution for the two organizations positively affecting their market values through this partnership. Both companies come with deep experience and a vision for excellence, which will also drive better service experience for clients”.  ]]> https://biospectrumindia.com/news/97/17183/icmr-approves-himedia-syngene-covid-19-antibody-test-kit.html https://biospectrumindia.com/news/97/17183/icmr-approves-himedia-syngene-covid-19-antibody-test-kit.html Wed, 09 Sep 2020 00:00:00 +0530 HiMedia Laboratories, a bioscience company with expertise in media manufacturing and diagnostics, and Syngene International, an integrated research and development services company, have collaborated to manufacture ELISafe 19TM, an IgG based ELISA test kit for COVID-19 now approved by the Indian Council of Medical Research (ICMR). The ELISafe 19TM antibody test kit has a sensitivity of 100% and specificity of 99%. Commenting on the news, Dr. Vishal G. Warke, Director R&D, Cell Culture and Immunology, HiMedia Laboratories, said, “We appreciate the prompt response of the ICMR in reviewing and approving the ELISafe 19TM kit. The kit is a result of a unique combination of skills: Syngene’s expertise in viral research and HiMedia’s ability to manufacture and commercialise the product. The kit is made in India for the benefit of Indian hospitals and patients and it will play a significant role in testing for SARS-CoV-2 antibodies facilitating tracking of the progression of infection and immunity to future infection.” Dr. Mahesh Bhalgat, Chief Operating Officer, Syngene International Ltd. added, “Since the declaration of the COVID-19 pandemic, there has been an urgent need for simple and specific testing tools that not only detect the presence of the coronavirus but also contribute to the surveillance of the immune response to the virus. The ELISafe 19TM testing kit fills this gap. This type of serological detection of SARS-CoV-2 antibodies will generate invaluable data and provide the basis for epidemiological studies of immunity in the community: a significant advance in the management of this highly infectious disease in India.” The use of an IgG antibody test offers the opportunity to study and understand the percentage of population exposed to SARS-CoV-2 infection. The ELISafe19TM kit is intended for qualitative detection of IgG SARS-CoV-2 antibodies using the standard ELISA method on human serum/plasma samples. The kit will also help to identify the IgG immune status of COVID-19 recovered patients so that their plasma can be used for therapeutics. Syngene developed the IgG based ELISA at its research facility in Bengaluru and partnered with HiMedia to manufacture and commercialise the product. HiMedia is seeking approval from the Central Drugs Standard Control Organisation (CDSCO) and will launch the kits once approval is in place. ]]> https://biospectrumindia.com/news/97/17170/dep-uses-meshworks-technology-to-extend-life-of-hip-implants.html https://biospectrumindia.com/news/97/17170/dep-uses-meshworks-technology-to-extend-life-of-hip-implants.html Tue, 08 Sep 2020 00:00:00 +0530 Total Hip Replacement (THR) requires a complex design that is strong enough to withstand long durations of load. Bone implant designs must be precise and durable in order to withstand significant load and pressure over time.  Detroit Engineered Products (DEP) effectively tackled this challenge by developing 3D CAD models for implants and building an effective fatigue evaluation model to assess the life cycle of various implants.  Through its proprietary CAE platform, MeshWorks, DEP utilized unique morphing and meshing tools in order to further understand non-standard hip implant geometries. This enabled DEP to carry out hypothetical test scenarios and estimate the fatigue life of implants, which resulted in significant benefits in extending the overall life of the implants.    Radha Krishnan, Founder & President, Detroit Engineered Products, said, “DEP’s MeshWorks technology provides a unique platform that allow users to generate multiple, customizable designs based on customer variations. It helps in reducing the design time vis-à-vis traditional methods of implant design. It also brings down the design costs for companies and serves as a comparative tool for different competitive products. Our sole aim is to bring a transformation in the product development industry and introduce organizations to new age technologies.”    With its in-house design team and CAE platform, DEP’s implant designs provide the critical ability to obtain fatigue life cycles of implants and run multiple different tests upfront in the design process to help combat uncertainty once the implant is created and implemented. Additionally, DEP’s implant designs are durable in order to withstand sufficient durations of load and provide an added level of certainty, during the design stages, for the life cycles of each implant designed.   ]]> https://biospectrumindia.com/news/97/17149/india-to-double-testing-capacity-with-new-diagnostic-project.html https://biospectrumindia.com/news/97/17149/india-to-double-testing-capacity-with-new-diagnostic-project.html Thu, 03 Sep 2020 00:00:00 +0530 A major project has been launched to indigenously manufacture, in bulk quantities and at much lower costs, all reagents needed for RT-qPCR-based and other molecular methods of diagnostics of Covid-19. The Rockefeller Foundation has provided financial support for the project executed by the Bangalore Life Science Cluster, which would improve access to Covid-19 diagnostics across the country.  The newly launched project called Indigenisation of Diagnostics (InDx), anchored at Centre for Cellular and Molecular Platforms (CCAMP), aims to build a robust supply-chain network of Indian MSMEs capable of producing reagents that go into a testing kit as well as manufacture testing kits. The project involves identifying bottlenecks in the supply-chain network, short-falls in quality levels and gaps in the ability of these MSMEs to scale-up. The project would hand-hold MSMEs in meeting both quality and quantity such that the network would be able to put together a million indigenous kits a day. The project employs a dynamic digital supply-chain platform developed pro-bono by Tata Consultancy Services (TCS). In addition, the project envisages providing support to maintain a sustainable business plan for the consortium with the help of experts in the field.    Prof K VijayRaghavan, the Principal Scientific Advisor to the Govt of India, who is overseeing India's efforts of indigenisation of biomedical products, said "this is a multipurpose project addressing not only the Covid-19 crisis, but aimed at helping MSMEs to expand their business opportunities and to improve the overall healthcare system by developing more high quality, but low cost molecular diagnostics. Important collaboration with The Rockefeller Foundation will enable our MSMEs to meet global standards”.    "The generous support by The Rockefeller Foundation and enthusiastic response by MSMEs to participate in the proposed supply-chain network has given the confidence that we would be able to meet the target of 1 million kits per day within the next few months", says Dr Taslimarif Saiyed, CEO of CCAMP, who heads the project at Bangalore LifeScience Cluster.  Prof Satyajit Mayor, Director of NCBS, Bangalore, an advisor to the project says "This initiative may help innovations in our ability to meet global quality and thereby our MSMEs may not only be able to serve the Indian market and be able to export to the other needy countries at very competitive prices. We hope to expand the project to include other new molecular diagnostic methods such as Lateral Flow Assays or LAMP-based assays for COVID19 testing, newly developed saliva-based sampling tests, which are point of care tests and also scalable to test at scale".  Strengthening India's ability to develop fully indigenous diagnostic kits is expected to improve the entire healthcare system as affordable molecular diagnostics may soon be available for other diseases, particularly cancer and rare tropical diseases" says Prof LS Shashidhara, Dean (Research) at Ashoka University, who is also an advisor to the project. ]]> https://biospectrumindia.com/news/97/17130/oncquest-acquires-quest-diagnostics-indian-facilities-.html https://biospectrumindia.com/news/97/17130/oncquest-acquires-quest-diagnostics-indian-facilities-.html Tue, 01 Sep 2020 15:15:00 +0530 Oncquest Laboratories, India’s leading and fastest-growing chain of super-specialized laboratories has recently announced the acquisition of world-renowned Quest Diagnostic’s Indian facilities, from Strand Life Sciences. The acquisition adds a significant muscle power to Oncquest and will propel it into an aggressive growth trajectory. The erstwhile Quest diagnostic’s Gurugram facility was built with the best global standards in the year 2008 and is one of the largest Lab facilities in Asia. Quest exited India and sold off its entire India facilities to Strand Life Sciences in the year 2018, from whom it has been now acquired by Oncquest. The facility, located at A-17, Info City, Sector-34 Gurugram, will be the new Oncquest’ s National Reference Laboratory. The facility is NABL & CAP-accredited and can take care of all the segments of pathology testing. Speaking on the occasion, Aditya Burman, Promoter & MD, Oncquest Labs said, “This acquisition is just the right trigger we needed to catapult our growth plans. We do look forward to many more such synergistic acquisitions to help us ramp-up our operations in India. We are known for providing solutions to “difficult diagnosis” and with this, we hope to consolidate our position further. We are very excited about the possibilities. We look forward to filling the gaps and offer customized solutions at all levels of healthcare platform”. ]]> https://biospectrumindia.com/news/97/17122/mapmygenome-introduces-collection-kit-for-covid-19-testing-.html https://biospectrumindia.com/news/97/17122/mapmygenome-introduces-collection-kit-for-covid-19-testing-.html Mon, 31 Aug 2020 14:35:00 +0530 Mapmygenome has recently announced the launch of a new product Covisafe™, a collection kit for COVID diagnostic testing. CSIR-Centre for cellular and molecular biology validated and certified the kit to be as per ICMR protocols. The kit developed by the Hyderabad based company consists of a nasopharyngeal/oropharyngeal swab which, post sampling, is placed in a stabilizing solution containing RNAShield™, a proprietary US FDA approved reagent from US-based Zymo Research. The solution effectively inactivates the virus without compromising the integrity of DNA/RNA. The reagent does not interfere with the downstream process and need not be removed from the sample, before or during RNA extraction. Mapmygenome is committed to providing COVID-19 reagents and collection kits that DO NOT USE bovine or swine derived ingredients.  Advantages of Covisafe kit: Since the virus is rendered ineffective right after sampling, there is minimal risk to the healthcare providers and staff after the sample is collected. Samples collected in the Covisafe kit can be transported safely at ambient temperatures and do not require cold-chain transport. The viral samples remain stable for prolonged periods of time and can be kept for up to 30 days at temperatures below 25°C. Samples collected in these kits are not vulnerable to degradation during multiple freeze-thaw cycles, unlike VTM samples.  The Covisafe kit can be used directly in the lab (no preprocessing needed to remove the stabilizer reagent) and is compatible with RNA extraction kits from standard providers such as Roche, Qiagen, ThermoFisher, etc.   ]]> https://biospectrumindia.com/news/97/17118/divoc-launches-first-telemedicine-diagnosis-lab-in-india.html https://biospectrumindia.com/news/97/17118/divoc-launches-first-telemedicine-diagnosis-lab-in-india.html Fri, 28 Aug 2020 17:10:00 +0530 DIVOC health has launched its first, one-of-a-kind, technologically advanced DIVOC laboratories in New Delhi to create the most advanced digital diagnostic laboratory network. Through the new-age labs of the future, it facilitates patients to have a lab at the comfort of their homes. It has also introduced at-home, instant diagnostics which would allow phlebotomists to conduct testing and deliver results right away. The lab has collaborated with United Kingdom laboratories to bring 21st-century innovations into diagnostics. With faster results i.e within 20 minutes at home, DIVOC is also empowering and enabling the overall telemedicine segment in India.  This innovation will enable a new generation of medicine where the operations can extend into peoples’ homes and the diagnostic continuum can empower a truly connected, omnipresent vision of health. DIVOC laboratories offer more than 500 tests including Clinical Chemistry, Clinical Microbiology, Hematology, Serology, Clinical Microscopy, Cytopathology, and Molecular Biology.  DIVOC Laboratories offer more than 500 tests including Clinical Chemistry, Clinical Microbiology, Hematology, Serology, Clinical Microscopy, Cytopathology and Molecular Biology DIVOC Laboratories has set up a state of the art facility in Okhla, New Delhi which can enable a variety of testing. Facilitating people with telemedicine, the lab of the future will provide Instant Home Kit, Drug Delivery and also, work with existing aggregators to provide Doctors. To bring the latest innovations, advanced concepts and technology for the benefit of clinics and patients, the Divoc labs focus on validation, knowledge management, new technology evaluation, new assay development, R&D and contract research. ]]> https://biospectrumindia.com/news/97/17105/oscar-medicare-develops-first-indigenous-rapid-ab-test-for-covid-19-detection.html https://biospectrumindia.com/news/97/17105/oscar-medicare-develops-first-indigenous-rapid-ab-test-for-covid-19-detection.html Wed, 26 Aug 2020 00:00:00 +0530 New Delhi based Oscar Medicare, manufacturer of various in-vitro diagnostic kits, has developed a rapid test for detection of Corona virus antibody (Ab) using recombinant proteins developed indigenously in collaboration with Dhiti Life Sciences in New Delhi. The recombinant protein of corona virus was developed by the scientific team under guidance of Dr. Abhinav Shrestha, a young scientist and Ph.D from National Institute of Immunology-Delhi. The developmental work of recombinant protein of COVID-19 was initiated in the month of April looking urgent need of active raw material to bypass the dependency on foreign suppliers and country to support the vision of the Govt. of India “Aatma Nirbhar Bharat’. Being a DSIR approved biotechnology lab, it was easy for the team of Dhiti Life Science to approach Dept of Biotechnology (DBT), BIRAC and other Govt agencies including THSTI for support in the development of 100% Indian test. Dhiti Life Sciences has received BIRAC grant under their COVID-19 call for the project titled as “Development of Lateral flow test for the detection of anti-corona virus SARS-COV-2 specific IgG & IgM from human sera”. Under the same project above antigen and hence fully indigenous lateral flow device has been developed in collaboration with Oscar Medicare. ‘OSCAR CORONA ANTIBODY DETECTION TEST” is a rapid test kit which is quite simple to use and perform the even at bed side of the patient or at home. A small drop of finger pricked whole blood or Serum / plasma is sufficient to perform the tests and visual results can be obtained within 5 to 20 minutes. It is a qualitative rapid in-vitro diagnostic test which provides the information that whether suspected person has been exposed or not to COVID-19. The test is quite simple to perform in any general healthcare facilities without needs of specialized laboratory technologist and additional equipment. The kit is very stable at room temperature and its storage and transportation will not be an issue as per Indian climate. The product has been validated and approved by ICMR lab-National Institute of Virology-Pune. As per ICMR report, OSCAR CORONA Antibody detection test has sensitivity of more than 97.66 % and specificity of 99%.   Among the few manufacturer of rapid tests kits in Delhi NCR, Oscar is the first company to develop and validate the product with recombinant proteins of 100% Indian origin. ]]> https://biospectrumindia.com/news/97/17091/bit-designing-aptamer-based-diagnostic-kit-for-covid-19-detection.html https://biospectrumindia.com/news/97/17091/bit-designing-aptamer-based-diagnostic-kit-for-covid-19-detection.html Mon, 24 Aug 2020 00:00:00 +0530 With support from the Science and Engineering Research Board (SERB), a statutory body under the Department of Science and Technology (DST), Birla Institute of Technology (BIT), Mesra, Ranchi, has initiated a research with the detection of a target protein using bioinformatics tool against which the diagnostic kit has to be developed. This study has taken the special domain of spike protein in consideration for the development of the diagnostic kit. The researchers are developing an aptamer-based diagnostic kit for detection of SARS-Co-V2 infection. Their study will first ensure the detection of corona virus infection while subsequently, the kit will also differentiate the various types of corona virus infection (SARS Co-V1, MERS) including COVID 19 infection. The general corona virus infection may be detected on the basis of conserved domain present in all three corona virus infection (SARS Co-V1, MERS & COVID 19) while the differential kit will be developed on the basis of combination of conserved and non-conserved domain present in SARS-CoV2 virus, SARS-CoV2 virus & MERS virus respectively. Armed with state-of-art expertise in molecular biology and drug delivery domain, Dr. Abhimanyu Dev, Assistant Professor at Birla Institute of Technology, Mesra (BIT Mesra) Ranchi, has teamed up with Dr. Venkatesan Jayaprakash, Associate Professor of the same Institute to carry out this research. The development of the diagnostic kit will be done at Birla Institute of Technology, Mesra lab while testing of kit will be conducted at Institute of Life Sciences (ILS), Bhubaneswar under supervision of Dr. Rajeeb Kumar Swain, Scientist E, ILS Bhubaneswar. The aptamer-based technology is a relatively new technique. It can detect a number of infections in precise & efficient manner. Besides, it makes detection of COVID 19 infection less costly and the devices can be stored in less stringent conditions, making it more effective over conventional antibody-based detection techniques, especially for the rural and remotely located population. The detection of other corona virus infection (SARS-Co-V1 & MERS) will also be an added advantage of our research. This kit also has the advantage of detecting corona virus infection in very less time as it will be a rapid diagnostic kit for detection based on the change in colour. Further, the kit will be less costly in comparison to antibody-based detection technique due to low production cost and requirement of the less stringent storage facility. ]]> https://biospectrumindia.com/news/97/17073/transasia-unveils-indigenous-erbalisa-covid-19-elisa-test-kits-.html https://biospectrumindia.com/news/97/17073/transasia-unveils-indigenous-erbalisa-covid-19-elisa-test-kits-.html Thu, 20 Aug 2020 00:00:00 +0530 Mumbai based Transasia Bio-Medicals Ltd., India’s leading IVD company has launched “Made in India” ErbaLisa COVID-19 IgG ELISA-based antibody test kits for detection of COVID-19. Designed and developed in India, the ErbaLisa COVID-19 IgG ELISA kits are a perfect solution to fight the current scenario of the pandemic in the country. The kits have been validated for a proven sensitivity and specificity of >99% and are suitable for use on all widely available semi and fully automated ELISA systems.  “For the last 40 years, Transasia has been meeting the needs for quality, diagnostic solutions that are accessible and affordable. Very early on, we identified that Manufacturing in India is the only way forward to reduce the dependency on imports and make India truly ATMA NIRBHAR. Our ErbaLisa COVID-19 IgG ELISA kits are a result of dedicated efforts of our R&D team in India. We are proud to remain committed to ATMA NIRBHAR BHARAT by manufacturing these kits in India”, said Suresh Vazirani, Chairman and Managing Director, Transasia-Erba group.   “We are thankful to ICMR and NARI for acknowledging our efforts in developing the COVID-19 testing kits. This approval has come at the right time, as India ramps up its testing capacity and inches towards normalcy. Manufacturing these kits in India, will help us further offer affordable kits that are accessible to the citizens of India and contribute to the government’s strategy of test, treat and track”, added Ravi Kaushik, CEO, Transasia Bio-Medicals Ltd. ErbaLisa COVID-19 IgG kit has been evaluated and approved by National AIDS Research Institute (NARI), Pune, and is included in the ICMR’s list of validated COVID-19 IgG antibody tests. The kits have also approved by CE IVD. The kit offers the following advantages: Sample required for test – Blood Serum/Plasma Assay time – 90 min Simplified protocol with In-Well Sample Dilution Ready to use reagents Semi-quantitative result > 99% sensitivity and specificity Adaptable to automation “The government has put in a lot of efforts to slow down the surge in the spread of the infection in India. As a company that is truly Indian by heart, we are proud to contribute to the fight against COVID-19. This kit is made in India for the people of India and is dedicated to all COVID heroes who have been relentlessly, ensuring the health of the nation, often putting their own health at risk,” concluded Anil Jotwani, Sr. President, Sales & Marketing, Transasia Bio-Medicals Ltd. Transasia’s R&D team based in Mumbai, has been working round-the-clock to develop the kit and evaluate it on a large number of population belonging to different demographics in India. The high sensitivity and specificity offered by the MADE IN INDIA ErbaLisa COVID-19 IgG kits can help policy makers plan and implement appropriate public health interventions for prevention and control of the disease. These ready-to-use kits can test up to 96 samples and give results in a couple of hours. ]]> https://biospectrumindia.com/news/97/17053/iit-delhi-to-develop-home-based-covid-19-testing-kit.html https://biospectrumindia.com/news/97/17053/iit-delhi-to-develop-home-based-covid-19-testing-kit.html Tue, 18 Aug 2020 00:00:00 +0530 US based Wells Fargo International Solutions Private Limited through their philanthropic partner, United Way of Bengaluru (UWBe), has joined hands with IIT Delhi in this fight against coronavirus. IIT Delhi and Wells Fargo recently signed a Memorandum of Understanding (MoU) for the development of a peptide-based ELISA test for the detection of COVID-19 antibodies.   ELISA, short for serological enzyme-linked immunosorbent assay, determines whether a person possesses antibodies for COVID-19 in the blood. The test results can help the medical fraternity fight the disease in many ways; a significant way would be the identification of individuals with antibodies who can donate their blood as part of an experimental treatment of infected patients.   This project- a collaboration between IIT Delhi and National Chemical Laboratory (NCL), Pune - has the potential of making a meaningful difference to this situation by enabling affordable, home-based testing.    This research will utilise the microplate-based enzyme immune-assay technique. The choice of antigen will be a peptide that has been computationally identified. Structural analysis of the available complex will be performed to design a novel peptide that has a complementary property with spike protein of COVID-19.   A set of peptides will be designed using a combination approach to test their binding. From the sequences of the variable regions of the Heavy and Light chain including the novel designed peptide, cloning of the mAb fragment (CV-Fab) will be performed. CV-Fab will be produced from which ELISA based testing kits will created. ]]> https://biospectrumindia.com/news/97/17014/iit-g-rr-animal-healthcare-develop-indigenous-covid-19-diagnostic-kits.html https://biospectrumindia.com/news/97/17014/iit-g-rr-animal-healthcare-develop-indigenous-covid-19-diagnostic-kits.html Tue, 11 Aug 2020 06:50:00 +0530 Indian Institute of Technology Guwahati and Hyderabad based RR Animal Healthcare Ltd. have been successful in jointly developing and delivering large quantities of affordable COVID-19 related diagnostic kits. With this initiative, IIT Guwahati has become the first institute in the country to demonstrate an efficient model to develop import-substitute COVID-19 kits from lab-scale to prototype level, field/hospital testing and commercialising thereby saving valuable foreign exchange for the country, timely delivery and customising as per the needs of the user. These kits, being developed presently at the Center of Nanotechnology, IIT Guwahati, are now supplied regularly in large quantities to the National Health Mission, Assam and several hospitals across the country. The launch of these indigenously developed COVID-19 kits, by Minister of Finance, Health and Family Welfare, Assam Himanta Biswa Sarma, was held on 18 June 2020. These included initially the ICMR approved “SPILD” Viral Transport Media (VTM) Kits. Over the past several months, with the lockdown being implemented across the country and with very less air connectivity, acquiring large quantities of COVID-19 kits became very difficult. To overcome this crisis, the National Health Mission, Assam had approached Prof. T. G. Sitharam, Director, IIT Guwahati, with a request to develop Viral Transport Media (VTM) kits, RNA extraction kits and RT-PCR kits and help the state government in their efforts to overcome this shortage. IIT Guwahati immediately took up this challenge and strategised to develop these kits in-house to meet the growing requirement of these kits during this time of COVID-19 pandemic. More than 2.5 Lakhs VTM kits developed at IIT Guwahati have already been supplied to NHM, Assam. Several testing laboratories across the country have also started procuring these import substitute kits due to their high quality, affordable price and timely delivery schedules. The performance of the indigenously developed RNA extraction kits have also been highly satisfactory as per the Guwahati Medical College and Hospital (GMCH) and the Institute has started supplying these RNA extraction kits in large quantities to the state government. Similarly, the indigenously developed RT-PCR kits are being validated presently and the production, as well as supply, of these kits is likely to commence soon. These affordable and sterile “SPILD” Viral Transport Media (VTM) kits, RT-PCR kits and RNA isolation kits have been developed at the Center for Nanotechnology, IIT Guwahati, jointly with RR Animal Healthcare Ltd. with inputs from GMCH by the research teams led by Prof. Parameswar Krishnan Iyer, Prof. Siddhartha Sankar Ghosh from IIT Guwahati and Dr. Labanyamoy Kole and Dr. Debashish Dutta of RR Animal Healthcare. ]]> https://biospectrumindia.com/news/97/17009/trivitron-brings-full-suite-of-indigenous-covid-19-testing-products.html https://biospectrumindia.com/news/97/17009/trivitron-brings-full-suite-of-indigenous-covid-19-testing-products.html Mon, 10 Aug 2020 13:05:00 +0530 Chennai based company Trivitron Healthcare is pleased to announce the launch of a full suite of indigenously developed COVID-19 Testing products, as the organization’s contribution towards Atmanirbhar (self-reliant) Bharat. Trivitron Healthcare offers a comprehensive range of ICMR approved COVID-19 solutions including RT-PCR Tests (COVIDsure&COVIDsure Pro), RNA Extraction kits (RNAsure), Viral Transport Media (ViSure), Total Antibody ELISA Test (COVIDscreen Plus) and ELISA IgG (COVID Kavach IgG) testing kits for Covid-19. Realizing the enormous need of testing kits in the domestic market, to address this, the organization has indigenously designed & developed, and had started large scale manufacturing for COVID-19 RT‑PCR test kits, RNA Extraction kits, Viral Transport Media, ELISA Antibody Tests, and will soon be launching Rapid POC Tests as well, for the Indian market. Trivitron is committed to manufacturer cost-effective and globally-accepted high-quality kits, and other COVID-19 solutions. “We have been focused on making world-class Made-in-India medical technology solutions for domestic and global markets. The current situation of COVID-19 pandemic demanded innovation in developing indigenous and economical testing kits for the Indian market and we have responded to this. We have a complete range of COVID testing portfolio which will enable scaling up of current testing needs of the Indian & International Healthcare Ecosystem.’’ said, Dr. GSK Velu, Chairman and Managing Director, Trivitron Healthcare. ]]> https://biospectrumindia.com/news/97/16989/kidod-drdo-develop-rapid-testing-machine-for-covid-19-.html https://biospectrumindia.com/news/97/16989/kidod-drdo-develop-rapid-testing-machine-for-covid-19-.html Fri, 07 Aug 2020 00:00:00 +0530 Israel based Kidod Sience & Technologies Ltd. has recently developed a non-invasive detection device (size of a desktop computer) for COVID-19 testing, which does not need an expert or any qualified personnel. The device can detect the virus by Saliva sample only, using the Ion-Mobility Spectrometry (IMS) technique. This testing is done in association with DRDO India.  COVID-19 has the highest spikes so it can attach to the upper respiratory cells at a higher rate than any other viruses. This Virion test has 95% accuracy rate and Result in 50 seconds. In order to renew international flights without endangering the passengers and destination inhabitants, Virion test can screen a huge number of passengers with accuracy and within a reasonable price too. This can be done within one minute, it’s very fast – less than 50 seconds. The procedure is very simple and the testing rate is up to 70 per hour. Where in with Virion Test Covid-19 virus can be detected in 50 seconds with a device having Ion-Mobility Spectrometry (IMS) technique. It can detect at the early stage of cells destroying by the virus with a sensitivity of as low as 150 picograms. IMS technique used to separate and identify trace number of ionized molecules in the gas phase based on their mobility in a carrier buffer gas. ]]> https://biospectrumindia.com/news/97/16981/siemens-healthineers-obtains-first-fda-eua-authorization-for-cov2g-ab-test.html https://biospectrumindia.com/news/97/16981/siemens-healthineers-obtains-first-fda-eua-authorization-for-cov2g-ab-test.html Wed, 05 Aug 2020 15:15:00 +0530 German fim Siemens Healthineers has announced that it has received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody (Ab) test. This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 %. The COV2G antibody test offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein, specifically S1RBD—a key protein on the surface of the SARS-CoV-2 virus—within their focus. The COV2G antibody test is available on an expansive installed base of analyzers installed in the U.S. and in countries that accept the CE mark worldwide. SARS-CoV-2 Total antibody assay [COV2T] is currently being used by several reputed clinical laboratories and institutions on the company's reliable high throughput automated chemiluminescence analyzers including Atellica Solution, ADVIA Centaur and Dimension EXL series for sero-surveillance. SARS-CoV-2 Total antibody assay [COV2T] that detects both IgM and longer-lasting IgG antibodies is available in India since June 2020. ]]> https://biospectrumindia.com/news/97/16924/roche-launches-cobas-8800-in-india-for-sars-cov-2-testing-.html https://biospectrumindia.com/news/97/16924/roche-launches-cobas-8800-in-india-for-sars-cov-2-testing-.html Tue, 28 Jul 2020 11:00:00 +0530 Roche Diagnostics India has announced the launch of its first Cobas 8800 instrument at National Institute of Cholera and Enteric Diseases, Kolkata also known as ICMR-NICED. Cobas 6800 was launched at National Institute for Research in Reproductive Health, Mumbai also known as ICMR- NIRRH to aid with SARS CoV-2 diagnostic testing. Operating on the real-time reverse transcription polymerase chain reaction (RT-PCR) platform, SARS-CoV-2 diagnostic tests on the instrument detects the genetic signature (RNA) of the virus in a simple test performed by a healthcare provider using nasopharyngeal and oropharyngeal swab samples. Dr. Shravan Subramanyam, Managing Director India and Neighbouring markets, Roche Diagnostics India said, “Diagnostic testing is an important element of India’s battle against COVID-19, as we see a steady rise in infections across almost all parts of the country. High-volume and high-quality diagnostic tests are important to provide appropriate clinical support in time and implement social measures that can further avoid the infected spread the virus. The cobas 6800/8800 addresses almost all of the challenges faced by the labs in pandemic times – reduced turnaround time, maintaining testing efficiency and improved productivity of lab personnel on account of automation. Roche Diagnostics India is committed to providing technologies to help healthcare providers and patients in India.” ]]> https://biospectrumindia.com/news/97/16914/iit-kgp-creates-portable-rapid-diagnostic-device-for-covid-19-detection-.html https://biospectrumindia.com/news/97/16914/iit-kgp-creates-portable-rapid-diagnostic-device-for-covid-19-detection-.html Mon, 27 Jul 2020 10:00:00 +0530 In a unique effort, researchers at IIT Kharagpur (Kgp) have innovated a novel portable rapid diagnostic device to detect COVID-19 infection. This first-of-its-kind device will bring the testing for COVID-19 out from the walls of expensive laboratories and RT-PCR machines and enable testing at affordable costs for the under-served community across the world. This entire test can be conducted in an ultra-low-cost portable enclosure as an alternative to specialized laboratory equipment. The same portable unit can be used for a large number of tests, on mere replacement of the paper cartridge after each test. The device has been proven to produce no false result with remarkable accuracy and sensitivity compatible to standard RT-PCR tests. This test has an unprecedented low cost of less than Rs 400 per test, taking all components of expenses and business model into account. A video in English about the Novel Technology of IIT Kharagpur's first-of-its-kind portable rapid diagnostic device for COVID-19 can be found by clicking on this link - https://fromsmash.com/IIT-KGP-COVID-Testing-Novel-Technology. The Equipment developed by IIT Kharagpur Researchers will cost about Rs 2,000 if a pilot facility is used. Use of a large-scale commercial facility will further reduce with increase in the production scale. This compares very favourably with the RT PCR machine costing Rs 15 Lakh. Further, Dr. Arindam Mondal, Assistant Professor, School of Bio Science, IIT Kharagpur, added, “The unique portable device developed by the IIT Kharagpur researchers has not only been validated for the diagnostics of COVID-19, but also been designed to be capable of detecting any other kind of RNA virus by following the same generic procedure. The impact of this, therefore, is long lasting, empowered by the capability of detecting unforeseen viral pandemics in the coming years that may potentially endanger human lives time and again.”  The project received financial support from the Institute in late April as Prof. V K Tewari, Director, IIT Kharagpur, decided to set up a fund to support COVID-19 related research and product development. “This unique innovation is aligned with the Institutional vision to develop high-end healthcare technologies that can be afforded by the ailing common people all around the globe at virtually no cost, and is likely to make significant breakthrough in global viral pandemic management”, opined Director Prof. V K Tewari. The Ministry of Human Resources Development, Govt. of India has also been reaching out to all technical institutions regarding ongoing research work to help address India's increasing need to augment testing facilities. The results from this new technology have been strictly validated by following all established laboratory controls against the benchmarked results obtained from RT-PCR machine, using synthetic viral RNA. The synthetic RNA is exactly the same replicate of the viral RNA extracted from infected patients, as per accepted scientific benchmarking procedure, and is used for validating laboratory tests to avoid undue contamination and danger due to spreading of infection while handling sensitive body-fluid samples. IIT Kharagpur is ready for commercialization of the product. Any corporate or start-up can approach the Institute for technology licensing and commercial scale of production. The Institute is open to tie-ups, including a mode where the government intervenes with regards to meeting our low-cost healthcare objective for the under-served community as a policy measure to protect the interest of public health amidst the pandemic situation, instead of merely developing a strong profit-oriented model. ]]> https://biospectrumindia.com/news/97/16884/sanghi-medical-centre-starts-antibody-testing-for-covid-19.html https://biospectrumindia.com/news/97/16884/sanghi-medical-centre-starts-antibody-testing-for-covid-19.html Thu, 23 Jul 2020 07:15:00 +0530 Sanghi Medical Centre, a reputed, world-class, multi-specialty NABL-accredited pathlabhas joined the league of private labs in Delhi offering antibody testing for Covid-19 (IgG). The simple blood test is used to assess if a person has been exposed to the novel coronavirus infection or not, using highly sofiscicated immune assay analyzer. The brand has over 10 labs across India and has been delivering top notch healthcare services since over 35 years With Sanghi Medical Centre, a person can be assured of highly accurate and fast results. The labworks with trained personnel, offering optimum safety for all those who get the test done. It has an extensive array of offerings, alongside an unwavering adherence to the stringent global standards. The lab has to its credit the prestigious National Accreditation Board for Testing and Calibration of Laboratories (NABL) accreditation for its Pathology Laboratory, the top accreditation for any laboratory in India. Speaking about this, Dr Vikram Sanghi, CEO, Sanghi Medical Centre, said, “The antibody test is different, RT-PCR  from a Covid-19 diagnostic test and helps in determining whether an individual has developed possible immunity against the disease. It will also help in learning more about the infection and recovery rate, among other things. What is more is that the test can also tell us whether a person can donate plasma or not in case they have the required antibodies. Since inception, we have been committed to ensuring that our customers get the best lab and diagnostic services, and with us they can assured of the best health outcomes.” A RT-PCR coronavirus test looks for signs of active virus. However, it only indicates whether a person has the virus in the body at the time of testing. An antibody test, on the other hand, shows whether a person has had the virus at some point in the past – it could be gone or he/she may be still be contagious. The test will also enable in the identification of antibodies being produced to combat Covid-19. The antibody test offered by Sanghi Medical Centre is done by the CMIA or chemiluminescence method which has a specificity & sensitivity of >99%. If the test is positive, it means the person has developed antibody and possible immunity to the disease. The lab’s accurate offering is a good way of understanding the further course of action in the fight against Covid-19 and can be done wherever the individual is: at home, in the pathlab or even in the car. Sanghi Medical ensures optimum safety, being an accredited pathlab and the results can be collected in a day’s time. The price per test is INR 1450. ]]> https://biospectrumindia.com/news/97/16876/diacarta-receives-icmr-approval-for-quantivirus-sars-cov-2-test.html https://biospectrumindia.com/news/97/16876/diacarta-receives-icmr-approval-for-quantivirus-sars-cov-2-test.html Tue, 21 Jul 2020 07:15:00 +0530 US based company DiaCarta, a precision molecular diagnostics company with a unique, patented XNA technology platform for the development of novel liquid biopsy tests, has announced that its QuantiVirus™ SARS-CoV-2 RT-PCR test kit has been successfully evaluated by the Indian Council of Medical Research (ICMR). The evaluation showed 100% sensitivity and 100% specificity without any interference with other respiratory viruses and has been cleared for sale in the Indian market. “With an urgent global need for the availability of highly sensitive and specific tests to minimize the risk of false-negative results and mitigate the ongoing transmission of the deadly virus, we are pleased that our test has met the stringent requirements of the regulatory agencies in Mexico and India and has received regulatory approvals,” said Dr. Ramanathan Vairavan, Senior Vice President at DiaCarta. He further said that “with increasing incidence of COVID-19 around the globe, there is a need for cost efficient tests that are easy to perform on commonly available qPCR platforms. At DiaCarta, we are committed to work with governmental and private institutions to increase test availability and arrest the spread of the coronavirus. In addition, the DiaCarta CLIA certified laboratory in the San Francisco Bay Area has been actively engaged to provide COVID-19 testing to support America’s Back to Work and Back to School initiatives.” ]]> https://biospectrumindia.com/news/97/16868/jncasr-spinoff-launches-molecular-probes-for-covid-19-test-kits.html https://biospectrumindia.com/news/97/16868/jncasr-spinoff-launches-molecular-probes-for-covid-19-test-kits.html Mon, 20 Jul 2020 08:00:00 +0530 VNIR Biotechnologies Private Limited, a spinoff by Bengaluru based Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) an autonomous institute of the Department of Science & Technology, Government of India has launched indigenous fluorescence probes and Polymerase chain reaction (PCR) mix for Reverse transcription polymerase chain reaction (RT-PCR) detection which are molecular probes used in COVID-19 test kits. VNIR Biotechnologies Private Limited is incubated at Bangalore Bio-innovation Centre (BBC) of Government of Karnataka. Prof. T. Govindaraju and Dr. Meher Prakash, co-founders of VNIR have developed the Florescence probes and PCR mix for RTPCR detection. These molecular probes are used in COVID-19 test kits. A typical, PCR based test kit has three critical components (oligos, enzymes, molecular probes). The first two are partly available in India and partly imported while molecular probes used in COVID 19 tests, however are only imported. The molecular probes are used to track the amplification in PCR. Their immediate application is for COVID-19 testing, but they are general-purpose molecular tools for molecular diagnostic tests of several diseases. VNIR has innovated synthesis protocols for a suite of molecular probes, which will be useful for PCR based COVID-19 testing. VNIR will be filing for the protection of its process innovation. ]]> https://biospectrumindia.com/news/97/16867/aimed-wadhwani-foundation-support-msmes-in-the-medtech-sector.html https://biospectrumindia.com/news/97/16867/aimed-wadhwani-foundation-support-msmes-in-the-medtech-sector.html Fri, 17 Jul 2020 16:00:00 +0530 Association of Indian Medical Device Industry (AiMeD) has entered into a strategic partnership with Bengaluru based Wadhwani Foundation, a global non-profit organization to help the MSMEs address the various challenges faced by them at this critical time of Covid-19 pandemic to create an Aatma Nirbhar Bharat. Through this partnership, Wadhwani Foundation in coordination with AiMeD will provide soft assistance to AiMeD’s Progressive MSME Members to enable them to survive and grow amidst the current crisis through the Sahayata Program. The Sahayata Program aims to provide a growth path for small businesses by addressing their strategic, operational and talent needs. AiMeD and Wadhwani Foundation will jointly select  around 200 of its Progressive MSME partners to engage with through the Sahayata program, over the next few months. Under this outcome-oriented program, the MSMEs will receive personalized, actionable content in the form of videos, readings, articles, playbooks and infographics curated by the Wadhwani Foundation, one-on-one mentorship from experts and access to consultants and advisors for further guidance on finding solutions to MSME’s key business challenges. MSMEs will have bespoke engagement models based on their business requirements. The main objectives of the Sahayata Program are: To ignite growth of Progressive MSMEs in the MedTech sector and generate employment To inculcate the habit of operational, strategic and technological excellence among MSMEs in MedTechso that they can expand their competitive advantage To provide and train MSMEs on best practices in supply chain, manufacturing, Go-To-Market, etc. Help build a sustainable eco system as an identified growth driver under the AtmaNirbhar Program launched by Govt of India Help build both soft and hard infrastructure to accelerate  and sustain growth This is the first of its kind initiative in the Indian MedTechMSME ecosystem and aims to provide the targeted expertise to the MSMEs across varied areas. The Sahayata Program coupled with the various stimulus measures announced by the government will help the MedTech sector to grow during the current difficult times. ]]> https://biospectrumindia.com/news/97/16861/iit-d-launches-most-affordable-covid-19-detection-kit.html https://biospectrumindia.com/news/97/16861/iit-d-launches-most-affordable-covid-19-detection-kit.html Fri, 17 Jul 2020 06:10:00 +0530 Union Human Resource Development Minister, Ramesh Pokhriyal 'Nishank’ e-launched the world’s most affordable RT-PCR based COVID-19 diagnostic kit Corosure developed by IIT Delhi and approved by the ICMR and DCGI in New Delhi. Pokhriyal informed that the diagnostic kit developed by IIT Delhi, which will be now available for use by the authorised testing labs with this launch, will significantly bring down the cost of COVID-19 RT-PCR testing. The base price of the RT-PCR assay is Rs 399. Even after adding the RNA isolation and laboratory charges, the cost per test will be considerably cheaper compared to currently available kits in the market. The Minister further informed that IIT Delhi has given license to 10 companies to manufacture COVID-19 diagnostic kit using the technology developed by its researchers. In April 2020, IIT Delhi became the first academic institution to obtain the ICMR’s approval for a real-time PCR-based diagnostic assay. It was also the first probe-free assay for COVID-19 approved by the ICMR. The assay was validated at the government’s medical research body with a sensitivity and specificity of 100%.   ]]> https://biospectrumindia.com/news/97/16839/marico-selects-world-class-ventilator-and-respiratory-solutions.html https://biospectrumindia.com/news/97/16839/marico-selects-world-class-ventilator-and-respiratory-solutions.html Wed, 15 Jul 2020 06:10:00 +0530 Marico Innovation Foundation (MIF), announced the conclusion of the #Innovate2BeatCOVID Grand Challenge with the selection of India’s top 3 innovative ‘Ventilators and Other Respiratory Solutions’, offering INR 85 lakhs in grants. This announcement comes on the heels of the last announcement, wherein INR 160 lakhs were disbursed as grants to 3 innovative ‘Personal Protective Equipment (PPE)’ category solutions. Committed to the cause of nation-building through innovation, Marico Innovation Foundation brought together a formidable group of interventionalists, pulmonologists, public health officials and healthcare industry leaders to identify effective and scalable solutions in response to the global pandemic.  Speaking on the initiative, Mr. Harsh Mariwala, Founder of Marico Innovation Foundation & Chairman of Marico Ltd said, “Through this challenge, we bring forth unique solutions that cater to the entire spectrum of current ventilator requirements all at a fraction of the cost of international counterparts. They are built by India with best in class features and technology with global applications. The devices are disruptive, accessible and affordable - which is exactly the need of the hour.” Marico Innovation Foundation will boost the efforts of the selected innovators by providing access to business opportunities, mentorship and guidance on business operations so that they can reach the right pockets of India. From the winning solutions identified, some devices are clinically validated and some are in the process of getting ISO certified in order to meet all the regulatory requirements. The innovations selected are geared to support the entire spectrum of patients and hospitals both from short term ventilation (during transit and home care) to in-patient wards where periodic ventilation is required and finally solutions for critical support in ICUs – and all this at competitive price points that match global standards. The solutions selected will help the Indian healthcare community stay prepared to tackle the rapidly rising number of COVID- 19 cases as we become the 3rd most-affected nation in the world. Padma Vibhushan Dr. Raghunath Mashelkar, Hon’ Chairperson of Governing Council of Marico Innovation Foundation and Jury chair for the Grand Challenge shared on the occasion, ”At Marico Innovation Foundation, we have always considered innovation to be the keystone of progress, and what better way to use our wealth of experience working with innovations, than in the time of a crisis.” He added, “Our collaboration with eminent industry experts, healthcare leaders along with A.T.E. Chandra Foundation has accelerated the process of finding the right innovations for the pandemic challenges. I am confident that these innovators are primed to make a difference and empower our frontline workers at different levels.”  The winners under ‘Ventilators and Other Respiratory Solutions’ category include: Shreeyash Electro Medicals has designed an indigenous ventilator with advanced features at par with most high-end, expensive imported ventilators and is available to hospitals at an attractive price that is ~20% of existing market prices to help fight the pandemic. It is suitable for both adult and paediatric ICUs across the globe and can be used in both invasive and non-invasive modes. Among other advanced technical features, one that stands out is the capability of the device to be set to an ‘automatic ventilation’ mode ensuring continued safe ventilation of an unattended patient. The device allows doctors to control for a wide range of both the volume of delivered air and the pressure that a patient may need, a feature commonly found only in high-end, expensive ventilators. They have successfully completed clinical validation and received endorsement by intensivists for use in ICU settings. They have also completed an approved registration of this ventilator with the Central Drugs Standard Control Organisation (CDSCO), India’s national regulatory body for medical devices. They are currently undergoing testing for safety and essential performance of medical electrical equipment as per standard IEC 60601-1 by an NABL-accredited laboratory. KPIT Technologies’ solution is ergonomically designed and focuses on user-friendliness to create a completely automatic air compression mechanism that substantially reduces cost compared to traditional critical care ventilators. With these features, along with its unique cylindrical shape, KPIT’s ventilator is portable and compatible for different settings including remote medical facilities, ambulances and home-care. The 13 kgs lightweight, yet mechanically sturdy device will be priced at ~30% of similar devices in the market. KPIT has secured calibration certification for its various features from an NABL-accredited laboratory. KPIT has also completed an approved registration of its ventilator with the Central Drugs Standard Control Organisation (CDSCO). It is currently undergoing testing for safety and essential performance of medical electrical equipment as per standard IEC 60601-1 by an NABL-accredited laboratory. KPIT is also undergoing clinical validation and is already seeing buyer interest for bulk-orders for their frugal innovation. Nocca Robotics, has developed an ICU ventilator that can be used for invasive requirements. This is a turbine-based ventilator that eliminates the requirement of any compressed medical air to operate, an infrastructure that might be not available in many healthcare settings in India. The ventilator also comes with an in-built battery and claims to run the device for long hours in the event of a power cut-off. This device stands apart for being at par with most high-end, expensive imported ventilators, but is competitively priced at ~30% of its closest competitors’ rate. The winning solutions has successfully completed its clinical validation and is recommended to be used in ICU by intensivists after being tested on patients suffering from critical lung infection. The ventilator has been tested for safety and essential performance of medical electrical equipment by an NABL-accredited laboratory as per standard IEC 60601-1. The ventilator has also undergone endurance testing for more than 24 days at a hospital in Pune.  Mr. Amit Chandra, Vice-Chairperson, Marico Innovation Foundation, and Chairman Bain Capital India Office said, ““Our hope with these wonderful innovations is to see Indian entrepreneurs provide solutions that will address important healthcare needs - be it disruptive cost, comfort, or suffering of patient and frontline workers.” Marico Innovation Foundation has always been committed to fostering innovation and solving societal and humanistic challenges faced by our nation. As such the foundation has worked with over 100 innovations over the last two decades in order to make a positive, measurable, and sustainable impact on the world we inhabit. During the pandemic too, the foundation rallied together to call forth innovators and was able to identify 6 ingenious and unique solutions that respond to the most pressing challenges faced by our healthcare and frontline communities. The foundation continues to work closely with these innovators to swiftly scale them up. The efforts include helping build operational efficiencies, connections with relevant buyers, and B2B business opportunities.   ]]> https://biospectrumindia.com/news/97/16835/adamas-university-ess-to-develop-automated-diagnostic-tool-for-covid-19.html https://biospectrumindia.com/news/97/16835/adamas-university-ess-to-develop-automated-diagnostic-tool-for-covid-19.html Tue, 14 Jul 2020 07:15:00 +0530 Kolkata based Adamas University has signed a project based Memorandum of Understanding, with Elmax Systems & Solutions ( ISO 9001:2015 Certified company and enlisted with MSME. Govt. of India) in Kolkata to develop a cloud based automated diagnostic tool to detect coronavirus disease using radiographs. This is the first ever attempt by any Indian University towards a cloud based AI enabled faster & low-cost solution to the problem based on Multiple Hypothesis Inference Criterion. The novelty is in a single point multi-hypothesis based faster detection of COVID-19 from Radiography images & other medical vital conditions with severity score tag for early detection of nCOVID-19 patients and necessary measures.  The Automated Detection Tool developed by Adamas University and ESS aims to offer a valuable second opinion to the doctors and assist them in the screening process. This type of mechanism will provide results to the doctors quickly and in an efficient and accurate manner.  Mr. Debashis Chakrabarti, CEO of ESS and alumni of IIT-Kharagpur said that, “In this software, we have developed an Artificial Intelligence based Technique for detecting COVID-19 on Chest Radiographs(X-Ray or CT Scans) ,other medical vitals like temperature , saturation percentage of Oxygen and even pathological data from Blood Routine Examination like Leukocyte, Lymphocyte & Neutrophil.”  The technique would also act as an aid to the conventional RT-PCR based method to isolate the contracted individuals.  The project will see utilization of the techniques of data science and machine learning on radiograph images along with other parameters to successfully detect the COVID-19. ]]> https://biospectrumindia.com/news/97/16814/who-endorses-truenat-assays-to-detect-rifampicin-resistance.html https://biospectrumindia.com/news/97/16814/who-endorses-truenat-assays-to-detect-rifampicin-resistance.html Fri, 10 Jul 2020 08:45:00 +0530 The Foundation for Innovative New Diagnostics (FIND), Molbio Diagnostics and the Indian Council of Medical Research (ICMR) have announced that the World Health Organization (WHO) has now endorsed three of their rapid molecular Truenat™ assays for initial diagnosis of tuberculosis (TB) and subsequent detection ofrifampicin resistance in adults and children with signs and symptoms of pulmonary TB. Both Truenat MTB and Truenat MTB Plus detect Mycobacterium tuberculosis bacteria for TB diagnosis, while Truenat MTB-RIF Dx identifies resistance to rifampicin, the most commonly used first-line treatment. All three tests are run on the portable, battery-operated Truenat device and provide results in less than an hour. Truenat was developed by Bigtec Labs, the R&D subsidiary of Molbio Diagnostics. ICMR conducted multicentre validation of Truenat MTB and Truenat MTB-RIF Dx assays followed by a feasibility study under the national programme and found them to be on par with the internationally recognized Xpert®MTB/RIFmolecular assay (Cepheid, Sunnyvale, USA) in terms of sensitivity and specificity, and detection of rifampicin resistance. Truenat assays have now been incorporated into the India National TB Elimination Programme (NTEP) after recommendation from ICMR. ]]> https://biospectrumindia.com/news/97/16805/mylab-steps-up-to-automate-molecular-diagnostics.html https://biospectrumindia.com/news/97/16805/mylab-steps-up-to-automate-molecular-diagnostics.html Tue, 07 Jul 2020 13:00:00 +0530 Pune-based molecular diagnostics company, Mylab Discovery Solutions has launched ‘Compact XL’ - India’s first fully-automated Sample-to-PCR-ready system for molecular diagnostics. The machine is designed to automate lab operations from sample handling to RT-PCR ready tube preparation, and do these operations in one single compact benchtop machine. Compact XL is a cartridge-based machine and can test multiple samples concurrently. Compact XL can be used for a wide range of RNA/DNA-based tests including Covid-19 RT-PCR tests. The machine can take a variety of sample types such as plasma, tissue, sputum and swab. Speaking about the benefits of this 100% indigenously developed machine, Hasmukh Rawal, MD, Mylab Discovery Solutions said, “To make India self reliant in advanced diagnostics, Compact XL is our most ambitious project to date. Compact XL will replace the need of 700 sq ft of clean room lab with a 4x3 benchtop machine and reduce the need of 3-4 expert technicians to just one, thus saving operational costs for labs. From patients’ perspective, automated processes will eliminate errors and improve accuracy, for example, the robotic movements in machine are precise to the tune of hundred-thousandths of a ml when handling liquids” Adar Poonawalla, CEO of the Serum Institute of India (SII), who unveiled the machine, said that “Scientific and technological breakthroughs are driving our fight against Covid-19. This revolutionary product, with multiple patents already filed, will be a giant leap in making testing accessible. It will eliminate traditional barriers to the adoption of molecular diagnostics at labs and address any potential demand-supply gaps of highly skilled technicians for testing.” Abhijeet Pawar, Chairman, AP Globale, said that “An important lesson Covid has taught us to be self reliant. Our focus is to drive social change through innovation. The work at Mylab goes a long way in making diagnostics affordable and making India Atmnirbhar in testing. Compact XL is the next step in the same direction.” The Compact XL is one of its own kind platforms, with each component developed and designed in India. It has flexibility to test multiple parameters and can multiple samples at the same time. It will enable many small labs to expand their offering portfolio of advanced tests. Automated barcode reading, auto-fed protocol, self sanitization and LIMS connectivity makes Compact XL, as a complete walk-away system with low maintenance. Compact XL will be available for pre-ordering starting 13 July 2020. ]]> https://biospectrumindia.com/news/97/16786/transasia-steps-up-availability-of-elisa-test-kits.html https://biospectrumindia.com/news/97/16786/transasia-steps-up-availability-of-elisa-test-kits.html Mon, 06 Jul 2020 05:30:00 +0530 Mumbai based Transasia Bio-Medicals Ltd., has announced wide availability of its recently launched ELISA antibody test kits through its countrywide network of over 50,000 diagnostic labs. Named the ErbaLisa COVID-19 IgG, the ELISA test kits are 98percent accurate and come at 20 percent the cost of RT-PCR tests. The ICMR, in its advisory dated June 23, has allowed private laboratories and hospitals to conduct serological tests across the general population with a view to easing the country out of the three- month lockdown. The directive takes the authorized labs for COVID-19 testing from the current 500 to over 80,000 labs spread across the country. With the government’s directive for serosurveillanceand identification of asymptomatic individuals, the states have been asked to step up their testing capacity and make testing available to all symptomatic patients. Several states like Maharashtra, Delhi, Haryana, Uttar Pradesh and Jharkhand have ramped up their testing with mega door-to-door serological surveys, and with the new ICMR directive, more states are likely to follow suit. “With the country slowly trying to emerge from the lockdown and resume functionality, there is a need to scale up testing by at least five times in the next three months. ICMR’s mantra of Test, Track and Treat is very relevant in India to flatten the curve. ELISA test is a promising tool for sero surveillance and to know where the disease stands in the curve. It is with this thought that AntibodyELISA tests are being widely conducted in the US and Europe,” said Mr. Suresh Vazirani, Chairman and Managing Director, Transasia-Erba Group. Validated by ICMR and NIV, Transasia’s US-developed ErbaLisa COVID-19 IgG ELISA kit has more than 98% sensitivity and specificity, and is several times more affordable and accessible than RT-PCR. “Most labs in India are already equipped with ELISA automation and technicians are well trained for conducting ELISA tests, thus making it the ‘most conducive environment’ for testing. Compared to RT- PCR, the gold standard of testing, ELISA costs 80 percent lesser and allows for volume testing in a short time. The approved Rapid Ag tests, on the other hand, have a sensitivity of 50 percent, making it less reliable and requiring re-testing of large populations,” said Mr Ravi Kaushik, CEO, Transasia Bio-Medicals Ltd. “Transasia is well equipped to meet government’s current requirement of mass testing. Transasia’s US subsidiary, Calbiotech has a capacity to manufacture 25 lakhs tests per month. Further, our new COVID-19 dedicated manufacturing facility at AMTZ will localize ELISA antibody kits’ manufacturing that will increase the capacity by four times,” added Mr Kaushik. Several majorly affected countries in the world are already using Transasia’s ELISA antibody test kits for past two months. “Being a global IVD player, Transasia has been at the epicenter of managing this crisis in the US, Europe, Latin American and Far-East countries. Depending upon the level of sero-prevalence of infection, governments and policy makers can plan and implement for prevention and control of the disease, with periodic sero-surveys used to guide the policy makers,” said Mr. Vazirani. Through the last three months, since the occurrence of the first positive case in India, ICMR has been adopting a calibrated approach. In an effort to ramp up the testing capacity, the body recently released a comprehensive list of categories of people who should be tested as part of the sero survey, including high-risk or vulnerable populations like healthcare workers, frontline workers, immune-compromised individuals, individuals in containment zones, security staff, prisoners) to know who has been infected in the past and has now recovered. “In view of the surge of returning migrant labourers, States/UTs need to focus on more effective surveillance, contact tracing, adequate testing and timely treatment of all. This is especially true for 70 percent of the population who reside in 5,650 talukas in India. Through the recently launched iLAB, a state-of-the-art mobile lab, Transasia has partnered with the Government for conducting 400 ELISA tests per day in these remote areas,” cited Mr. Vazirani. “All through the lockdown, our manufacturing facilities continued to work to meet the demands of the Indian and global healthcare customers. Our sales and service frontline warriors, attended to close to 30,000 Doctors and lab technicians, to ensure uninterrupted services. With all these initiatives, Transasia remains committed to a Healthy and Atmanirbhar Bharat,” said Mr. Vazirani. ]]> https://biospectrumindia.com/news/97/16781/mtai-urges-govt-to-release-stalled-imports-of-medical-devices.html https://biospectrumindia.com/news/97/16781/mtai-urges-govt-to-release-stalled-imports-of-medical-devices.html Fri, 03 Jul 2020 09:10:00 +0530 Medical Technology Association of India (MTaI) has said that the government should release all consignments of medical devices at the earliest to meet the shortage of equipment for treatment of critical COVID-19 patients. MTaI represents global medical technology companies with a large footprint in manufacturing, and R&D in India. Many consignments of essential medical devices imported by these companies are held up at various Indian ports since 22nd June 2020. Consignments of critical medical devices including respiratory management devices like C-PAP machines, High-Flow Nasal Oxygen (HFNO) which are extensively used for COVID19 treatment are also stuck at the customs. Other critical medical device consignments like infrared thermometers, pulse oxymeters, video-laryngoscopes are also facing issues in getting customs clearances. Mr. Pavan Choudary, MTaI Chairman and Director General said “Only a sample check is carried out in cases where the importer is compliant with all customs norms. However, from the fourth week of June customs authorities have stalled all imports of medical devices saying that a thorough check is to be conducted. This is delaying the supply of critical equipment to hospitals. Many hospitals have been relentlessly following up with our member companies for the supplies.” “The non-availability of these products not only impacts the hospitals ability to treat current patients but also cripples any effort to expand capacity. As India is witnessing a daily surge in the COVID19 infection cases, the availability of medical device supplies becomes even more important. The government should release these essential medical device consignments after conducting the checks at the earliest,” he added. MTaI has already sent a representation to Department of Pharmaceuticals, Department for Promotion of Industry and Internal Trade, Central Board of Indirect Taxes and Customs, Customs Office of Chennai and Mumbai in this context.   ]]> https://biospectrumindia.com/news/97/16789/apollo-proton-cancer-centre-receives-jci-accreditation.html https://biospectrumindia.com/news/97/16789/apollo-proton-cancer-centre-receives-jci-accreditation.html Fri, 03 Jul 2020 00:00:00 +0530 Apollo Proton Cancer Centre (APCC), the first Proton Therapy Centre in South Asia and The Middle East, has announced its accreditation by Joint Commission International (JCI), the recognized global leader in health care accreditation. This makes APCC, India’s first dedicated advanced cancer centre to receive this international accreditation, and the 8 th hospital in the Apollo Hospitals Group to join the portfolio of JCI accredited hospitals. Since its commencement in June 2019, APCC has been the preferred cancer centre across the globe for Proton Therapy and Cancer Care Management. JCI accreditation is a prestigious achievement and benchmark in the healthcare industry for following the best global practices and offering exceptional patient care and safety. Dr. Prathap C Reddy, Chairman, Apollo Hospitals said, “More than 25 years ago, we noted the growing prevalence of cancer in India, the lack of Oncology centres in the country and this was the genesis of Apollo embarking on advanced cancer care. From the very beginning, we brought in the most advanced technologies in cancer care and even the recent launch of South Asia and the Middle East’s first Proton Therapy at Apollo Proton Cancer Centre, reiterates our commitment to investing in the best available care for our patients.  I am pleased that Apollo Proton Cancer Centre (APCC) has been accorded a special honour, it is now the first advanced cancer centre in India to be accredited by JCI. This recognition of our quality standards will further strengthen our resolve to keep raising the bar in Oncology!” The Joint Commission International accreditation is the gold standard given to organizations that practice and follow the highest International Standards in order to provide world-class patient care and safety. A team of expert JCI physicians, nurses, and health care administrators evaluated more than a thousand measurable elements and assessed the level of performance inrelation to established standards and efforts for continuous improvements. This accreditation is proof of the meticulous standards of hospital management and cancer treatment established in the centre, enabling improved and advanced care for patients. The Apollo Proton Cancer Centre introduced Proton Therapy for the first time in India with the expertise of a Multi-Disciplinary Cancer Management Teams and an organ-specific practice. It is also the first and only Proton Centre in South Asia and the Middle East. To date, over 200 patients from across the globe have benefitted from Proton Therapy, within its first year of operation. The core clinical values of the Oncology team enabled with technology makes the treatment successful. A team of well-experienced doctors, management personnel, nurses and care professionals ensure that patients feel safe, comfortable and receive the epitome of oncology care during their journey of cancer treatment. The accreditation has motivated the team to push themselves to bring all the efforts together and forge better healthcare standards.  “Joint Commission International (JCI) commends Apollo Proton Cancer Centre for its commitment to meeting international quality and patient safety standards by earning JCI accreditation during the global pandemic,” says Paula Wilson, president and CEO, JCI. “This achievement was possible by utilizing JCI’s virtual survey process, where surveys are conducted through the use of technology. This exemplifies how our virtual survey process supports physical distancing and other safety concerns while maintaining the same rigor as a JCI on-site survey.” The Apollo Proton Cancer Centre aspires to be the best in cancer treatment with a multi-faceted team, providing a top-notch, safe experience for patients. APCC completed the audit and received the accreditation despite the difficult times of COVID-19 to bring the healthcare of international standards within the reach of every individual. This achievement by the team is a matter of great pride not only to Apollo Group, but also to the nation by being the first advanced cancer hospital in India to be accredited by JCI. ]]> https://biospectrumindia.com/news/97/16796/srl-diagnostics-launches-immunity-check-package.html https://biospectrumindia.com/news/97/16796/srl-diagnostics-launches-immunity-check-package.html Fri, 03 Jul 2020 00:00:00 +0530 In an ongoing endeavor to encourage people to shift their approach towards healthcare from the curative to preventive, SRL Diagnostics, one of India's leading diagnostics chain, has launched Immunity Check Package, which will enable people to understand and assess their co-existing disease(s) and Immunity to live a healthy & happy life.SRL Diagnostics, under its preventive sub-brand SRL Care, is offering a panel of tests indicating the status of the three key components of the human immunity: Humoral, Cellular and Innate. The package includes tests like liver function test, general health & infection, iron, serum, IgE, glucose, Coronary Risk Profile, Creatinine, Sodium, Potassium and Chloride. It is well known that there is no single test that can determine one's immunity status, and therefore a panel of tests will enable people to understand their immune status and health risk. Sharing details about the Immunity Check Packages, Vikram Ahluwalia, Marketing Director, SRL Diagnostics, said, SRL Diagnostics has always focused on educating customers to lead a healthy lifestyle and has been at the fore-front of promoting preventive healthcare. Keeping in mind the current situation, people need to assess their immunity level better. It is a well-known fact that a healthy immune system can reduce the risks of infections or diseases. It is of utmost importance to adopt healthy habits, such as having a balanced diet, exercising and getting enough sleep to build a strong & healthy immune system.Alongside SRL has also introduced Smart+ Health Report, which provides an overview of one's health status, explanation of important parameters, and an alert on deviation from normal reference range in an attractive, pictorial and an easy to comprehend language. The added benefit to the Smart + Health report is the diet advice basis one's test report and consolidated guidance on further management of abnormal test parameters.  Sharing views on the technological advancement by SRL Diagnostics, Ahluwalia, added, It is important to use technology in terms of improving quality of care and work efficiency at an affordable cost, the COVID-19 pandemic has affirmed our move to be digitally ready. Our online appointment via the app has been useful in reducing patients' waiting times and hence minimizing crowd in the public waiting area, and thus allowing us to safely implement social distancing.SRL Diagnostics has always been at the fore-front of promoting preventive healthcare. As a leader in the category, the brand understands that the absence of a disease is always going to be of higher value to the society than achieving excellence in treating it. In July 2018, SRL Diagnostics launched its customized preventive health check platform under the brand name SRL Care. ]]> https://biospectrumindia.com/news/97/16764/nbri-sets-up-advanced-virology-lab-for-covid-19-testing.html https://biospectrumindia.com/news/97/16764/nbri-sets-up-advanced-virology-lab-for-covid-19-testing.html Wed, 01 Jul 2020 06:15:00 +0530 The National Botanical Research Institute (NBRI), Lucknow, has established an “Advanced Virology Lab” for testing COVID-19. The facility has been developed based on the guidelines of the Indian Council Medical Research (ICMR), the World Health Organisation (WHO), and the Ministry of Health and Family Welfare. It is a Bio Safety Level (BSL) 3 level facility. “Biosafety levels are assigned to a facility depending on the pathogen it deals with.  According to ICMR guidelines, BSL2 level facility is recommended for COVID-19 but this is an advanced version,” said Dr Samir Sawant, Senior Principal Scientist, NBRI. This advanced version has a “Negative Pressure”, which means it has a suction facility that can suck any aerosol and pass it through filters. It can filter virus or bacteria to make it a safe COVID-19 testing facility. It reduces the possibilities of infections at culturing facilities.  Prof. S K Barik, Director, NBRI, said that the facility will add to the testing capacity of Uttar Pradesh (UP). At present, UP is testing about 20,000 samples per day.  “To follow the protocol, we will start testing 100 samples a day in the first week and later we will scale it up to 500 samples a day,” said Dr Sawant. “As requested by the higher authorities of the Government of Uttar Pradesh and the Director General of the Council of Scientific and Industrial Research (DG-CSIR), NBRI took up the initiative for developing the testing facility in the wake of coronavirus pandemic as a service to the people of Uttar Pradesh,” Prof Barik  said. Prof. Barik also informed that a team of scientists and researchers from the Central Institute of Medicinal and Aromatic Plants (CIMAP), Lucknow, will also join the NBRI team for the testing of COVID samples. ]]> https://biospectrumindia.com/news/97/16754/roche-diagnostics-india-emphasises-on-severe-inflammatory-response.html https://biospectrumindia.com/news/97/16754/roche-diagnostics-india-emphasises-on-severe-inflammatory-response.html Tue, 30 Jun 2020 07:15:00 +0530 Roche Diagnostics India has highlighted its commitment to enabling access to reliable diagnostic solutions in India. Given the growing need to manage respiratory failure, Roche’s Elecsys IL-6 test measures levels of the biomarker interleukin 6 (IL-6) in human body and can be used to help identify patients who could be at high risk of development of severe respiratory illness. The test can support physicians, in combination with other examinations and vital signs, to decide early on about treatment management for severe respiratory illness. The levels of IL-6 also helps identify patients who might be at high risk of disease progression. Dr. Sandeep Sewlikar, Medical and Scientific Affairs Head, Roche Diagnostics India, said, “Roche Diagnostics India has been proactively working on addressing the country’s diagnostics need across a whole range of diseases and conditions. Responding to the need to address patient management relating to increasing cases of respiratory distress, I believe that our IL-6 biomarker plays the role of early indicator for acute inflammation in the management of critically ill patients.” Hospitals and laboratories can run the Elecsys IL-6 test on Roche’s cobas e analysers which are available in around 500 cities across India. These fully automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser. Dr. V Ramasubramanian, Infectious Diseases Specialist, Apollo Hospitals Chennai said, “Despite a high recovery and a low mortality rate, the number of cases in India is on a steady rise. With an already burdened public healthcare system, it is imperative to evaluate solutions that can facilitate timely treatment to critically ill patients. The IL-6 levels can help in tracking patients with a high risk of forthcoming respiratory failure. An IL-6 testing strategy will help facilitate early detection and timely treatment initiation.”   ]]> https://biospectrumindia.com/news/97/16749/icmr-invites-eoi-for-validating-rapid-ag-tests.html https://biospectrumindia.com/news/97/16749/icmr-invites-eoi-for-validating-rapid-ag-tests.html Mon, 29 Jun 2020 08:05:00 +0530 Since the entire public health machinery is focused to test, track and treat COVID-19 patients, it is imperative to explore the existing antigen-based assays as point-of-care tests for early detection of SARS-CoV-2. The Indian Council for Medical Research (ICMR) is inviting applications or Expression of Interest (EoI) for validation of rapid antigen (Ag) detection tests for COVID-19 from all manufacturers who have developed such test. So far, ICMR has validated and approved only one rapid antigen detection assay from SD Biosensor. ICMR has identified the following sites for validation of the rapid point-of-care antigen detection tests for COVID-19: All India Institute of Medical Sciences, Delhi SMS Medical College, Jaipur King George Medical University, Lucknow Kasturba Hospital for Infectious Diseases, Mumbai Post Graduate Institute of Medical Education & Research, Chandigarh Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry National Institute of Virology, Kerala Unit, Alappuzha ]]> https://biospectrumindia.com/news/97/16731/jncasr-sets-up-covid-19-diagnostic-training-centre.html https://biospectrumindia.com/news/97/16731/jncasr-sets-up-covid-19-diagnostic-training-centre.html Thu, 25 Jun 2020 08:00:00 +0530 Bengaluru based Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), an autonomous research institute under the Department of Science & Technology, Govt of India, has established a state-of-the-art COVID Diagnostic Training Centre at its Jakkur campus to help build capacity for the national fight against COVID 19 pandemic. Molecular diagnostic techniques, such as the real-time PCR, play a crucial role in the diagnosis and tracking of epidemics, including COVID-19. Unfortunately, India lacks personnel skilled in and adept at performing a real-time PCR in clinical diagnostics. Appreciating the crucial and unmet needs of the nation, JNCASR has embarked upon a campaign by establishing a state-of-the-art diagnostic training facility to train personnel in a real-time PCR for COVID-19. The primary objective of the program is to train multiple batches of trainees, 6-10 trainees per batch, in real-time PCR. The program envisages training people in multiple and sequential batches over the coming months through crash course spanning over a week. The first batch has undergone training from June 16 to 22, 2020, at COVID Training Facility, JNCASR. The comprehensive crash-course spanning over a week comprisesboth classroom lectures and laboratory experiments. The course is designed to impart theoretical knowledge as well as hands-on training.  The practical laboratory sessions have taught the participants the processing of infectious samples, nucleic acid extraction and preservation, real-time PCR and other molecular techniques, data analysis, and, importantly, standard operating protocols (SOP) of a clinical diagnostic facility.  Only simulated samples, not containing an infectious virus, have been used for training. Following the course, the trainees will be well-positioned to join a clinical diagnostic facility and handle samples in a clinical setup and perform a real-time PCR for not only COVID but any infectious organism. “Scientific robust training on handling and processing of infectious samples, use of real-time PCR and other molecular diagnostics, data analysis, and the standard operating protocols (SOP) of a clinical diagnostic facility are not only extraordinarily important in the time of COVID-19, but will continue to ensure the preparedness of the nation in the future to speedily address similar threats,” said Prof Ashutosh Sharma, Secretary, DST. The program is open for young candidates with a graduate or post-graduate degree in medical laboratory testing (MLT degree) offered by any medical institute in India. Personnel currently engaged in clinical service, and diagnostic laboratories are especially encouraged to apply for the training. Registered personnel are offered a suitable remuneration in addition to free boarding and lodging by the institute.  ]]> https://biospectrumindia.com/news/97/16730/govt-allocates-rs-2000-cr-to-supply-indigenous-ventilators.html https://biospectrumindia.com/news/97/16730/govt-allocates-rs-2000-cr-to-supply-indigenous-ventilators.html Thu, 25 Jun 2020 04:05:00 +0530 PM CARES Fund Trust has allocated Rs. 2000 crore for supply of 50000 ‘Made-in-India’ ventilators to government run COVID hospitals in all States/UTs. Further, a sum of Rs. 1000 crore has been allocated for the welfare of migrant labourers. Out of the 50000 ventilators, 30000 ventilators are being manufactured by M/s Bharat Electronics Limited.  The remaining 20000 ventilators are being manufactured by AgVa Healthcare (10000), AMTZ Basic (5650), AMTZ High End (4000) and Allied Medical (350). So far 2923 ventilators have been manufactured, out of which 1340 ventilators have already been delivered to the States/UTs.  The prominent recipients include Maharashtra (275), Delhi (275), Gujarat (175), Bihar (100), Karnataka (90), Rajasthan (75). By the end of June 2020, additional 14,000 ventilators will be delivered to all States/UTs. Further a sum of Rs. 1000 crore has already been released to States/UTs for welfare of the migrant labourers.  The distribution of the fund is based on the formula of 50% weightage for the population as per 2011 census, 40% weightage for number of positive COVID-19 cases and 10 % for equal distribution among all the States/UTs.  This assistance is to be used for arranging accommodation, food, medical treatment and transportation of the migrants. The main recipients of the grant are Maharashtra (181 cr), Uttar Pradesh (103 cr), Tamil Nadu (83 cr), Gujarat (66 cr), Delhi (55 cr), West Bengal (53 cr), Bihar (51 cr), Madhya Pradesh (50 cr), Rajasthan (50 cr) and Karnataka (34 cr). ]]> https://biospectrumindia.com/news/97/16716/abbott-to-supply-above-1m-tests-of-igg-ab-tests-to-india.html https://biospectrumindia.com/news/97/16716/abbott-to-supply-above-1m-tests-of-igg-ab-tests-to-india.html Tue, 23 Jun 2020 08:00:00 +0530 Abbott has announced that it has begun supply of its laboratory-based serology blood test for the detection of the antibody, IgG (Immunoglobulin G), that identifies if a person has had the novel coronavirus (COVID-19). Abbott has the capacity to provide millions of tests to India and is already in the process of delivering antibody tests to leading government and private hospitals and labs in Maharashtra, Delhi, West Bengal, Uttar Pradesh, Jammu & Kashmir and Gujarat. "Abbott is pleased to contribute to ICMR’s COVID-19 antibody testing strategy to use IgG CLIA antibody tests. Abbott’s recently launched SARS-CoV-2 IgG test can be used to understand the spread of transmission in high risk populations such as healthcare workers, immune-compromised individuals, frontline workers, or those in containment zones. These tests also provide valuable information to the public health officials about the spread in asymptomatic cases, helping us assess the impact of our public health efforts now and guide our COVID-19 response moving forward,” said Narendra Varde, General Manager and Country Head at Abbott’s diagnostics business in India. Mumbai’s Hinduja hospital was one of the first hospitals to evaluate the test in India. Dr. Tester F. Asha Vaid, Chief of Labs (Admn), Director Lab Research at Hinduja Hospital and Medical Research Centre, Mumbai, said, “This test is useful to clinicians and the community – our initial testing has yielded specific results for patients who were RT-PCR positive for COVID-19.” Abbott's SARS-CoV-2 IgG test specifically identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered. The test is used on the ARCHITECT® i1000SR and i2000SR laboratory instruments, which are installed in hospitals or laboratories throughout India and can run up to 100-200 tests per hour to help with reliable antibody testing during the pandemic.  Independent researchers found the test to have 99.9% specificity and 100% sensitivity for patients tested 17 days or more after symptoms began. ]]> https://biospectrumindia.com/news/97/16703/iit-g-develops-affordable-covid-19-test-kits.html https://biospectrumindia.com/news/97/16703/iit-g-develops-affordable-covid-19-test-kits.html Mon, 22 Jun 2020 06:10:00 +0530 Accurate testing is important to get out of the clutches of novel coronavirus. Stepping up efforts in this regard, the Indian Institute of Technology (IIT) Guwahati, in association with RR Animal Healthcare Ltd and Guwahati Medical College and Hospital (GMCH), has developed low-cost diagnostic kits. These are Viral Transport Media (VTM) kits, RT-PCR kits, and RNA isolation kits. The VTM kits are the first-stop source used to collect nasal and oral swab specimens from an individual source to a laboratory safely for culture and testing. During this period, the virus, if present, in the sample specimens should remain intact until the testing procedure is completed. The kit consists of a comprehensive solution specially formulated for the collection and transport of SARS-CoV-2. “To bring down the cost of kits, we have used material that are available in the local market and they are as per the World Health Organisation (WHO) recommendation. We have handed over two batches of these kits to the National Health Mission, Assam, and GMCH. We are making them in bulk to make it available to larger population,” said Prof. Parameswar Krishnan Iyer, lead researcher, IIT Guwahati.    Image caption- (From L to R) Laxmi Raman Adil, PhD student (IIT Guwahati), Dr. Pankaj Choudhury (RR Animal Health Care), Prof. ParameswarIyer and Prof. Siddhartha Ghosh (IIT Guwahati), Dr. Anil Bidkar (RR Animal Health care) ]]> https://biospectrumindia.com/news/97/16695/india-launches-mobile-covid-19-testing-lab.html https://biospectrumindia.com/news/97/16695/india-launches-mobile-covid-19-testing-lab.html Fri, 19 Jun 2020 09:05:00 +0530 The Minister for Science & Technology, Earth Sciences and Health & Family Welfare Dr Harsh Vardhan inaugurated and flagged off India’s first I-Lab (Infectious disease diagnostic lab) for Covid testing in rural and inaccessible areas of India, recently. This mobile testing facility will be deployed through the DBT testing hubs to remote regions of the country for Covid testing. There are now over 20 hubs in the country with 100 testing laboratories and these have tested more than 2,60,000 samples. The Department of Biotechnology (DBT), Ministry of Science & Technology along with Andhra Pradesh Med-tech Zone (AMTZ) has initiated the DBT-AMTZ COMManD [COVID Medtech Manufacturing Development] Consortia to address the shortage of critical healthcare technologies in India and move progressively towards a stage of self-sufficiency. Under this Consortia, India’s first I- lab (infectious disease diagnostic lab) has been built at AMTZ in record time of 8 days from the date of receipt of Automotive Chassis, from Bharat Benz. This is a mobile diagnostic unit with biosafety facility. The I- lab is a BSL-2 facility with on-site ELISA, RT-PCR, Bio chemistry analysers. It can run 50 RT-PCR reactions and about 200 ELISA in a day.Double set of Machines can help increase the capacity to about 500 per day in 8 hours shift. It can be deployed in remote areas and can be lifted from Automotive Chassis and can be put on goods train for sending to any location in the country.The BSL -2 Lab is as per NABL specifications and is being attached to DBT’s certified Testing centres. ]]> https://biospectrumindia.com/news/97/16684/j-mitra-unveils-covid-19-elisa-test-kit.html https://biospectrumindia.com/news/97/16684/j-mitra-unveils-covid-19-elisa-test-kit.html Thu, 18 Jun 2020 05:05:00 +0530 New Delhi based J Mitra & Co. Pvt Ltd, India’s leading global MNC in the In-Vitro Diagnostics (IVD) industry has launched its state-of-the-art Covid-19 Test Kit in the Indian market. Based on the Double Sandwich Elisa technology, the test kit is known as COVID-19 [IgM, IgG, IgA] MICROLISA. It is a serology-based total antibody (IgM, IgG, IgA) detection assay. This factor makes the J Mitra Corona Test kit superior and more accurate than other similar tests available in the market. It is a detection assay for the indirect diagnosis of past exposure to COVID-19. All the Covid-19 antibodies are detected without a differentiation in antibodies, and this is the reason contributing to the superior performance of this test. Elisa tests are highly sensitive and specific, and detect the COVID-19 antibodies in patient blood samples. 96-tests can be performed in one single go (using an instrument) and the test results are available within 90 minutes. The COVID-19 [IgM, IgG, IgA] MICROLISA Elisa test kit has cleared all government parameters and received all necessary approvals, including Indian Council of Medical Research (ICMR) and Drug Controller General of India (DCGI). Speaking on the latest offering from the J Mitra stable, Lalit Mahajan, chairman said, “we have deployed extensive indigenous R&D for the development of this unique product. There has been substantial contribution in its development by International Centre for Genetic Engineering & Biotechnology (ICGEB) headed by Dr Navin Khanna. This is the first time that a total antibody detection assay kit for covid-19 has been developed in the Indian market. Using a combination of IgM, IgG and IgA antibody test increases the sensitivity, efficiency and efficacy of the test parameters, providing a more accurate diagnosis as compared to other test kits in the market.” Talking about the accuracy of the J Mitra covid-19 test kit, Lalit Mahajan further added, “The IgG antibody takes approximately 14 days to form after an infection, while IgM antibodies are the first antibody that the body forms after approximately 7 days when it fights a new infection. The presence of IgA antibodies in patient sample also gets detected simultaneously, in this test kit. IgA is considered a major effector in the defence mechanism against viruses and induces efficient IgA antibodies response. Its simultaneous detection along with IgM/IgG antibodies improves sensitivity of the test kit. because of this, the J Mitra covid-19 test is a more potent diagnostic kit, providing an opportunity to fight the disease during the pre-symptomatic phase and thus mitigating further risk.” Speaking on the production aspects, Jatin Mahajan, managing director said, “We are ready to meet the demand arising from all parts of the country. We have an immediate production capacity of 5 lakh test kits daily (or 1 crore test kits per month), but we have a dynamic production plant that can be augmented to double the production capacity in 3 days.” “The pricing of the kit is being worked out. We are a socially conscious company with a 50-year legacy of service to the nation –we will price it very competitive to ensure that it is available for the masses through all relevant government channels.” “This is a completely indigenous kit – an ‘atmanirbhar’ initiative with R&D done inhouse, and sourcing done from Indian manufacturers and suppliers. In keeping with the Government’s make in India initiative, we have created the most robust supply chain ecosystem for material sourcing as well as for supplying to various government agencies as per the demands”, he further added. ]]> https://biospectrumindia.com/news/97/16691/ortho-launches-two-covid-19-antibody-tests-.html https://biospectrumindia.com/news/97/16691/ortho-launches-two-covid-19-antibody-tests-.html Thu, 18 Jun 2020 00:00:00 +0530 With 6,287,771 confirmed cases worldwide and 379,941 deaths due to the novel coronavirus scourge —2,16,919 cases /5,815 deaths in India — healthcare professionals, researchers and government officials in the country and across the globe are racing against the clock to find solutions to better manage Covid-19 and save more lives and families…ICMR has asked states to conduct antibody tests on large scale. Study results show that even with 97% specificity, there is a chance of getting 30 false positive results out of 1,000 and with 99.6%, 4 false positive results out of 1,000. Only with 100% specificity can one be fully confident that the antibody positive test result is a true positive, such as with the one developed and launched recently by Ortho Clinical Diagnostics.   Why 100% specificity is vital Unlike many commercially available antibody test kits, Ortho’s high-throughput, automated VITROS® Anti-SARS-CoV-2 antibody tests are highly reliable and have demonstrated 100% specificity in assay validation studies. The tests can help to identify with high accuracy a previously infected patient who can donate antibody-containing plasma to treat severe COVID-19 patients. This is important because any inaccurate test result could lead to a plasma therapy without antibodies to SARS-CoV-2, the active ingredients in the convalescent plasma therapy. Both VITROS® Anti-SARS-CoV-2 antibody tests target the S1 subunit of the Spike (S) protein of SARS-CoV-2. The virus uses the S1 protein to bind to the angiotensin-converting enzyme 2 (ACE2) receptor to facilitate viral entry and infection.  Antibodies that can bind to S1 and block S1-ACE2 interaction can inhibit viral infection, which are called neutralizing antibodies.  The VITROS® Anti-SARS-CoV-2 antibody tests can detect neutralizing antibodies that bind to the S1 protein.  Ortho’s 100% specificity-compliant antibody assay for Covid-19 testing — the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total and IgG Reagent Packs and Calibrators — have now been included in the updated list of approved Rapid/ CLIA/ ELISA kits the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, GoI. (*No other company has 100% specificity).   New CDC guidelines The recent guidelines from the Centre for Disease Control and Prevention (CDC) for Covid-19 antibody testing emphasizes on the serological methods/antibody testing towards monitoring and responding to the Covid-19 pandemic. Antibodies most commonly become detectable 1-3 weeks after symptom onset, at which time evidence suggests that infectiousness is, possibly, greatly decreased and that some degree of immunity from future infection has developed. Serologic assays for SARS-CoV-2 with very high specificity, now available, can play an important role in understanding the virus’s epidemiology in the general population and identifying groups at higher risk for infection.   Recommended testing strategies The utility of laboratory tests depends on the sensitivity and specificity of the assays. Also, the predictive values of a test should be considered because these values affect the overall outcome of testing. o   Positive predictive value is the probability that individuals with positive test results are truly antibody-positive. o   Negative predictive value is the probability that individuals with negative test results are truly antibody-negative. o   Positive and negative predictive values are determined by the percentage of truly antibody-positive individuals in the tested population (prevalence, pre-test probability) and the sensitivity and specificity of the test.  Example explains best In a high-prevalence setting, the positive predictive value increases — meaning it is more likely that persons who test positive are truly antibody-positive — compared to a situation where the test is performed in a population with low-prevalence. When a test is used in a low-prevalence population, the positive predictive value drops because there are more false-positive results, since the pre-test probability is low. And so on. In the current pandemic, maximizing specificity, and thus positive predictive value, in a serologic algorithm is preferred in most instances, since the overall prevalence of antibodies in most populations is, possibly, low. Choosing a test with a very high specificity, perhaps 99.5% or greater, will yield a high positive predictive value in populations tested with prevalence >5%. Ortho Clinical Diagnostics’ VITROS® Anti-SARS-CoV-2 antibody test offers 100% specificity, providing high confidence to positive test results. These kits  have received EUA from U.S.FDA and are CE marked too. High throughput o   The VITROS®  analyzers ( i.e. instruments ) from Ortho can run up to 150 of these critical tests/hour.  o   The COVID-19 antibody tests can be run on all Ortho’s flagship laboratory analyzers, the VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. It will soon also be available on the VITROS® ECi/ECiQ Immunodiagnostic Systems.  Accuracy o   Ortho’s testing demonstrated high clinical performance — critical to ensuring confidence in the results these tests deliver.  The VITROS® Systems that have already been installed in hospitals and laboratories in India and the neighboring SAARC countries are self-contained and do not require any external water source to run, offering labs placement flexibility.  Production plans o   A limited quantity of test kits will be available in India in the coming days. o   Ortho will be in full production mode in the coming weeks. o   It plans to manufacture several million SARS-CoV-2 antibody tests over the next month. ]]> https://biospectrumindia.com/news/97/16669/philips-ships-out-first-make-in-india-affiniti-ultrasound-series-for-domestic-market.html https://biospectrumindia.com/news/97/16669/philips-ships-out-first-make-in-india-affiniti-ultrasound-series-for-domestic-market.html Mon, 15 Jun 2020 00:00:00 +0530 Royal Philips, a global leader in health technology, has announced the shipment of its first ‘Make in India’ Affiniti Ultrasound machine from its Healthcare Innovation Center (HIC) in Pune. A premium-quality ultrasound system, Affiniti series is India’s most esteemed series from Philips Ultrasound with over 1700 installations across the country. Affiniti series of ultrasound systems offer doctors a powerful combination of performance and workflow for quick and efficient diagnosis with low operating cost. The Affiniti series is renowned for its exceptional image quality across applications such as radiology, obstetrics & gynecology as well as cardiology, thereby, making it a truly shared service system. The new system features anatomically intelligent ultrasound that provides automatic anatomy recognition and quantification and PureWave transducer technology, which delivers better image quality. Designed keeping in mind the challenges of healthcare professionals, Affiniti creates an easier and more intuitive workflow to enhance detailed Radiology and OB/GYN exams. The production of the state-of-the-art Affiniti system locally ensures that the customers in India can benefit from standardized delivery timelines and affordability while being rest assured that the international quality protocols are met. Commenting on the milestone, Daniel Mazon, Vice Chairman and Managing Director, Philips Indian Subcontinent said “Aligned with the government’s focus on manufacturing in India, we are proud to announce the shipment of the first ‘Make in India’ Affiniti Ultrasound machine. Philips has been fully committed to providing top of the line solutions to India throughout our 90 years of presence in the country and this milestone is a testament to the special relationship that we share with India.” Sharing his experience of using Affiniti Ultrasound system, Dr Nitin Chaubal (MD, DMRD), Director -Thane Ultrasound Center, Thane commented “We have eight (8) Affiniti machines in our center, they are the most robust machines taking care of a large turnover of patients with various diagnostic problems. Our entire team is happy with these user-friendly machines capable of performing any type of scans covering the entire gamut of applications. We have had practically zero breakdowns over the years and the diagnostic yield has been unparalleled. I am extremely proud and happy to understand that Affiniti will now be manufactured in India.” Healthcare Innovation Centre (HIC) Pune is one of the global Philips’ facilities devoted to multi-modality healthcare manufacturing showcasing best in class lean, innovation, and operational excellence. It is specifically designed with innovation and manufacturing flexibility in mind so that it can quickly adapt to the ever-changing market needs and deliver quality healthcare products that meet international standards, across the globe. The Quality Management system at the HIC factory is certified to meet several medical device compliances including Europe, FDA, etc. Since its inception, Philips HIC has launched six global products and has successfully delivered 3000+ systems to customers in more than 100 different countries worldwide. ]]> https://biospectrumindia.com/news/97/16650/ccmb-develops-economical-diagnostic-test-for-covid-19.html https://biospectrumindia.com/news/97/16650/ccmb-develops-economical-diagnostic-test-for-covid-19.html Fri, 12 Jun 2020 10:10:00 +0530 The Indian Council of Medical Research (ICMR) has recommended only reverse transcription polymerase chain reaction (RT-qPCR) test for novel coronavirus testing. Researchers at the Centre for Cellular and Molecular Biology (CCMB) have developed a new low-cost and low-tech required test for SARS-CoV-2 testing. This test is known as reverse transcription nested PCR (RT-nPCR) test. This test does not require real-time quantitative RT-qPCR. The RT-nPCR developed by the CCMB research team has shown  comparable performance to the standard RT-qPCR test. The nested PCR (RT-nPCR) approach does not depend on RT-qPCR but uses standard RT-PCR as part of an endpoint assay. In the course of comparing the results of both tests, researchers found that the standard RT-qPCR test can have low detection efficiency (less than 50%) in a real testing scenario, which may be due to low viral representation in many samples. This finding brought home the importance of monitoring detection efficiency directly in test environments. “We developed and tested an RT-nPCR protocol comprising a multiplex primary RT-PCR for amplification of four SARS-CoV-2 amplicons and a control human amplicon followed by a secondary nested PCR for individual amplicons. We also examined the use of RT-nPCR in pooled testing and in direct amplification without RNA isolation,” said Dr Rakesh Mishra, Director, CCMB. The RNA isolated from nasopharyngeal swab samples that had been previously tested using one of the two RT-qPCR tests was examined using RT-nPCR and the results were compared. It was found that taking both standard RT-qPCR tests together, the RT-nPCR test was able to identify 90% of the detected samples as positive by RT-qPCR. It also detected 13% samples as positive among samples that were negative by the standard RT-qPCR test (likely false negatives). Based on the experimentally measured false negative rate by RT-nPCR tests from this study, it was estimated that as many as 50% of positive samples may escape detection in single pass testing by RT-qPCR in an actual testing scenario. “This new test is awaiting approval from ICMR. We might ask ICMR to use this test in those places where there are no RT-qPCR machines,” remarked Dr Mishra. ]]> https://biospectrumindia.com/news/97/16635/perkinelmer-india-receives-cdsco-approval-for-covid-19-test.html https://biospectrumindia.com/news/97/16635/perkinelmer-india-receives-cdsco-approval-for-covid-19-test.html Thu, 11 Jun 2020 06:10:00 +0530 PerkinElmer, Inc., a global leader committed to innovating for a healthier world, has announced that PerkinElmer India has received commercial approval by the Central Drugs Standard Control Organization (CDSCO) for the PerkinElmer New Coronavirus Nucleic Acid Detection Kit. This test is intended to help meet the heightened needs for COVID-19 testing in India.PerkinElmer’s RT-PCR test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). It is also marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is now available in over 30 countries worldwide.“COVID-19 continues to have a significant impact in India and it is imperative that testing facilities have the kits on hand to identify cases without delay. Receiving CDSCO approval for our RT-PCR test will bolster the solutions available to testing facilities across India and help toward improving health outcomes,” said Shripad Joshi, Director, India and South Asia, PerkinElmer. ]]> https://biospectrumindia.com/news/97/16625/air-venti-a-platform-to-access-ventilators-bipaps-.html https://biospectrumindia.com/news/97/16625/air-venti-a-platform-to-access-ventilators-bipaps-.html Mon, 08 Jun 2020 00:00:00 +0530 The COVID-19 pandemic has highlighted the acute shortage of VENTILATORS/BIPAPS for "Respiratory Intensive Care Unit" for the acutely ill patients. Valuable time is lost and the patient's lives are unnecessarily endangered. Even for patients willing to pay for the costs, many times relatives are left to fend for themselves running between many hospitals. This adds to severe mental trauma to close family and relatives. The consortium of Octaware Technologies Limited (Aggregator Platform), Transpact Enterprise Limited (MedTech), Centrium Healthcare, and RIDA Foundation (NGO) offer a Tech-enabled aggregator platform to address this challenge as follows: Problem: Mumbai has approx. 5000 ICU Beds, but the number of ICU beds with Ventilator is only 600. With COVID-19 impacting respiratory system of patients, the number of deaths is increasing daily due to a shortage of Ventilators in ICU. Current Gap: Smaller hospitals in Mumbai do have ICU units (Avg. 5-10 beds) but with only 1 or 2 Ventilators. Solution: A platform like "Uber for Ventilators" with Ventilator owner (Car owner), Hospital ICU unit (Driver), and patients (Passenger) offering online access to ICU Beds with Ventilators. Mobile/Web App: A mobile application "Air-Venti" for patients to search for available ICU beds with/without Ventilator and book. A backend mobile tracker application for Hospitals to update the allocation of ICU beds and patient discharge. At a later stage, integration of the IoT Ventilator machine for the real-time update of machine availability. Working Model: Individual sponsorer/Investor in Mumbai will invest Rs. 2 lacs and own the Ventilator or BiPAPs. These Ventilators will be deployed to the Hospitals to be managed by Intensivist and Respiratory Physicians. Mobile App "Air-Venti" available on App store will generate and direct the patients flow to the Hospitals registered on Air-Venti that includes VOD network Hospitals, private hospitals with ICU beds and government hospitals. A portion of the profit generated out of the billed amount will be shared with the Ventilator Owner.   In case of a medical emergency with the Ventilator owner, he can request to block for himself, and a Ventilator from the cloud (pool of Ventilators) or Standby Ventilator will be blocked on the first preference. Break-Even in approx. 12 months. Post- Pandemic, opportunity to sell in depreciated cost, or donate to charitable hospitals in India. The Ventilator can also be contributed as Endowment (Waqf)/CSR with 80(G) benefits. Needy patients will be provided discounted fees for using these donated Ventilators. The contributors (Endowment) can still be beneficiaries of the Ventilator in case of his emergency needs.   Benefits of Owning Ventilator: Peace of mind for nears and dears Large pool to access when in need of Ventilator in ICU Or use Standby Ventilator Or Take Ventilator offline for personal quarantine use at home Opportunity to generate income Help society during this crisis time.   Current Status: Availability of 50 Portable Ventilators and 100 BiPAPS with Manufacturer. A network of 10 Hospitals in the Mumbai suburb to allocate 50 ICU beds Respiratory Physicians and Intensivist on board to manage ICU Units, if required by Hospitals Mobile App already developed and being uploaded on play store.     The legalstructure in place to kick start the Future Plan: The platform will be enhanced to incorporate the accessibility of other medical devices such as dialysis machines for Kidney patients, Vestibulators for autistic children Next Step:  A team of 50 individuals willing to own Ventilators/BiPAPs and add on the VOD network in Phase 1. (50 Ventilators and 100 BiPAPs) Plan to scale to 500 Ventilators and 1500 BiPAPs within 3 months of going live in Phase 2. ]]> https://biospectrumindia.com/news/97/16617/smt-receives-ce-mark-approval-for-hydra-tavr-device.html https://biospectrumindia.com/news/97/16617/smt-receives-ce-mark-approval-for-hydra-tavr-device.html Sat, 06 Jun 2020 00:00:00 +0530 SMT (Sahajanand Medical Technology Pvt Ltd), the leading medical device company of India, focussed on innovative patient care in cardiovascular segment, has announced that Hydra TAVR device received European CE Mark approval for the treatment of patients diagnosed with aortic stenosis. This regulatory approval paves the path for SMT to tap into a fast growing $3.8 billion global market. Hydra aortic valve is a self-expandable nitinol based supra annular aortic system with a mechanism for recapturing of the valve during deployment. This unique property of the device helps in precise placement of the valve and ensures orthotopic deployment. Hydra is available in three sizes; 22mm, 26mm & 30mm and is selected depending upon the diameter of the native annulus from 18mm to 27mm. Clinical data from the Genesis trial conducted in India and presented at the India Valves Conference 2019 held in Chennai, confirm the system’s ability to eliminate significant aortic regurgitation. In another CE clinical study conducted in Europe, the system also demonstrated a strong safety profile on 110 patients enrolled till February 2020. The benefits of the Hydra Aortic Valve System are enabled by its frame design and repositionable and retrievable delivery system. The non-flared inflow section of the frame and supra-annular valve leaflet design ensures better aortic valvular area in smaller annuli and in valve-in-valve settings. The frame features 3 tentacles or antenna for better anchorage and larger cells (10mm) which give better access for the future coronary interventional procedures if required. The delivery cable is highly flexible and 18 French compatible, and the device can be recaptured, repositioned and retrieved even after 85%-90% of deployment of the valve thereby eliminating to almost zero complications of deployment of TAVR device. The precise orthotopic supra-annular placement, positioning and deployment is facilitated by this unique property of re-capturability of Hydra. SMT has established a regional headquarter in Ireland to better serve its customers in Europe and Middle East. In addition to R&D and manufacturing center in Ireland, SMT has established direct presence and local offices in most of the large markets in Europe. SMT launched Supraflex Cruz DES last year in Europe and got critical success. Now with Hydra, SMT will be able to better serve its customers and patients across Europe. ]]> https://biospectrumindia.com/news/97/16611/csir-cmeri-develops-new-indigenous-ventilator.html https://biospectrumindia.com/news/97/16611/csir-cmeri-develops-new-indigenous-ventilator.html Fri, 05 Jun 2020 10:05:00 +0530 Researchers at Durgapur-based Central Mechanical Engineering Research Institute (CMERI) have indigenously developed a ventilator amid rising cases of COVID-19. The new ventilator was unveiled in the presence of Prof. (Dr) Harish Hirani, Director, CSIR-CMERI, and Dr Arunangshu Ganguly, Chairman and Managing Director, Health World Hospitals Pvt Ltd, Durgapur. “The bellow design, controllers and embedded electronics of this ventilator have all been customised to ensure price efficacy as well as meeting the requirements of the relevant industries. The ventilator has undergone multiple technical and design changes after adopting critical feedbacks from healthcare professionals of the Health World Hospital and Vivekananda Hospital, Durgapur. This ventilator costs around Rs. 80,000-90,000. The ventilator will be further upgraded to meet the requirements of various other patient’s parameters”, said Prof. Hirani. “The efficacy of a ventilator for a patient is also correlated to the effective response of the attending healthcare personnel. Steadily, the approach of this Institute will be to harness artificial intelligence capabilities to automate the functioning of mechanical ventilators, so that the ventilators automatically respond to the fluctuating variables of a patient”, added Prof. Hirani. “CSIR-CMERI, in coordination with critical care experts of the Health World Hospitals, have studied and incrementally developed this ventilator”, explained Dr Arunangshu Ganguly. CSIR-CMERI, along with healthcare professionals, can revolutionize the ventilator development capability of the country. This will help in massive substitution of import dollars by strengthening the medical care manufacturing landscape of the country, believe scientists at the institution. “Since the individual parts of the ventilator can be independently developed by different industries, mass-development of this ventilator will help a broad spectrum of industries. The significantly reduced cost of the ventilators will help the economically marginalised sections of the society the most as well as help further fortify the Government-aided healthcare schemes. This will also help in upgrading the tertiary healthcare infrastructure. We are in conversation with several industries for quick commercialisation of this newly developed ventilator to ensure availability of these ventilators in makeshift hospitals, basic hospitals, and other healthcare facilities”, said Prof. Hirani. ]]> https://biospectrumindia.com/news/97/16602/iit-d-receives-funding-from-microsoft-for-covid-19-projects.html https://biospectrumindia.com/news/97/16602/iit-d-receives-funding-from-microsoft-for-covid-19-projects.html Thu, 04 Jun 2020 08:00:00 +0530 Research to tackle the COVID-19 situation continues at Indian Institute of Technology (IIT) Delhi, with focus on the early detection of the disease. Aiding this endeavour, Microsoft India has come forth to support two such projects of the institute. One of them pertains to ICMR approved probe-free real-time PCR-based COVID-19 detection assay developed at the Kusuma School of Biological Sciences (KSBS), IIT Delhi. This probe-free technology will be more affordable and easily scalable. The other project is a collaboration between IIT Delhi and National Chemical Laboratory, Pune, and aims to develop an ELISA based diagnostic serological assay against COVID-19. If successful, it will create an economical, commercial process for manufacturing the antigens used in ELISA and home-based diagnostic kits to offer an effective, quick, robust and affordable diagnostic solution to COVID-19 outbreak. “The funds from Microsoft India will be utilized for establishing a fast-PCR protocol for our ICMR-approved assay” said Prof. Vivekanandan Perumal (KSBS, IIT Delhi), Principal Investigator of the RT-PCR-based COVID-19 detection assay project. Further, Prof. Manoj B Menon (KSBS, IIT Delhi), the co-investigator of the project added, “We will also be optimising other COVID-19 RT-PCR assays currently being developed in our laboratory." ]]> https://biospectrumindia.com/news/97/16604/iit-mandi-develops-novel-hygiene-products-against-covid-19.html https://biospectrumindia.com/news/97/16604/iit-mandi-develops-novel-hygiene-products-against-covid-19.html Thu, 04 Jun 2020 00:00:00 +0530 Researchers at the Indian Institute of Technology Mandi have developed an Ultraviolet-C (UV-C) light-based portable disinfection box at a cost of ₹35,000 to disinfect metallic, plastic and cardboard products like wallets, keys, spectacles, bags, courier packages and parcels, among others, to minimise the risk of COVID-19. Minimising the risk is the key because this virus can live on these surfaces for up to 3 days.  Research has shown that UV-C light can achieve a high level of inactivation of a near-relative of COVID-19’s virus. Thus, reducing the risks of contagion among healthy people. In the workplace, it can be an excellent tool for disinfecting transit of goods. The structure of the box is based on a UV-C opaque covered frame. It consists of a cuboid container made of a wooden board (furniture grade) with a two-layer aluminium foil coating to prevent UV-C light leakage. Ten UV-C lamps with designated ratings are used to provide UV-C light exposure to object surfaces. These lamps are connected with automatic timer control that regulates the dose of UV-C light as per requirement for the specific object. Dr. Himanshu Pathak and Dr. Sunny Zafar, Assistant Professors, School of Engineering, IIT Mandi, identified the capability of UV-C light for the disinfecting objects against contamination of the novel COVID-19 virus. “The developed prototype is capable of disinfecting non-living objects like courier packets, travel bags, currency, wallets, wrist watches, mobile phones, laptops, books, stationery among others”, said Dr. Himanshu Pathak. “We are using ozone-free UV-C lamps (with 254 nm wavelength), as per the ISO: 15858:2016 standard for UV-C devices -safety information with almost no exposure to human operators.”, elaborates Dr. Sunny Zafar. Highlighting the benefits of the Disinfection Box in the COVID-19 perspective, the researchers said, “The developed prototype can disinfect all kinds of metal, plastic and cardboard-based products from the bacteria and SARS-CoV-2 virus within one-minute exposure of UV-C light, by eliminating up to 99%.” The research team providing expertise in this innovation include: Dr. Himanshu Pathak, Assistant Professor, School of Engineering, IIT Mandi Dr. Sunny Zafar, Assistant Professor, School of Engineering, IIT Mandi Dr. Hitesh Shrimali, Associate Professor, School of Computing & Electrical Engineering, IIT Mandi Dr. Prosenjit Mondal, Associate Professor, School of Basic Sciences, IIT Mandi Dr. Amit Prasad, Assistant Professor, School of Basic Sciences, IIT Mandi The prototype has been tested in an in-house lab facility at IIT Mandi against the bacteria 'Escherichia coli' and 'Staphylococcus aureus'. The prototype shows 99% efficacy to kill both bacteria within 40 seconds of UV-C light exposure. Furthermore, on testing the researchers found that UV-C lamps did not heat up the disinfected product.   Foot-operated Hand Sanitiser Dispenser Mr. Navish Sharma, Technical Assistant, Civil, IIT Mandi, along with his team members, Mr. Tilak Raj and Mr. Hans Raj, have developed a low-cost foot-operated hand sanitiser dispenser for sanitising hands without touching contaminated surfaces of the sanitiser bottle. In this dispenser, a spring reinforced foot pedal is installed which is connected to a pipe with a holder in which the sanitiser bottle will be placed. On pressing the foot pedal the sanitiser holder will lift and the bottle head will be pressed by a glass cap. This innovation costs less than ₹1,400 and is being installed in the various parts of the IIT Mandi campus. ]]> https://biospectrumindia.com/news/97/16599/clinimed-highlights-covid-19-impact-on-clinical-research-industry.html https://biospectrumindia.com/news/97/16599/clinimed-highlights-covid-19-impact-on-clinical-research-industry.html Wed, 03 Jun 2020 12:00:00 +0530 Clinimed LifeSciences Pvt. Ltd., Kolkata is gladly organizing a Webinar on “Strategies to Conduct Clinical Trials effectively in Covid-19 era” in association with Indian Society for Clinical Research (ISCR) and Peerless Hospital, Kolkata as knowledge partners, on 6 June 2020. The objective of this insightful webinar is to promote discussion among all stakeholders of clinical trials in the country on the effect Covid19 Pandemic will have on future clinical trials and clinical research industry. Our Distinguished Panelists are: Dr. V. G. Somani, Drug Controller General of India (DCGI) Mr. Anirban Roy Chowdhury, Codirector- Clinical Portfolio Management (CDSA, THSTI, DBT), Govt. of India & Executive Council Member, ISCR Ms. Suneela Thatte, Vice President & Head, R&D, IQVIA India, Executive Committee Member of ISCR. Dr. Roli Mathur, Head of ICMR Bioethics Unit Dr. Alben Sigamani, Group Head, Dept. of Clinical Research, Narayana Health Dr. Sanish Davis, R&D Director, Johnson & Johnson India; General Secretary, Indian Society for Clinical Research (ISCR) Dr. Soma Mukhopadhaya, Director of CliniMed LifeSciences; CEO of Netaji Subhas Chandra Bose Cancer Hospital, Kolkata Our Moderator is:   Dr. Subhrojyoti Bhowmick, MD Clinical Director, Research &Academics, Peerless Hospital, Kolkata NABH assessor for hospitals and ethics committee accreditation. Takeaways from this Webinar: In this webinar, attendees will learn about: Understanding the impact of today’s environment on clinical trials (data, sites, milestones) and their patients What regulatory changes were brought into effect during the pandemic that will change the future of clinical research How innovations in technology were used to support clinical research during the pandemic in order to keep trials on track and make future trials more efficient Role of SMOs/ CROs/ Sponsors/ ISCR/ Institution in managing clinical trials in COVID-19 Pandemic CliniMed LifeSciences Pvt. Ltd., a start-up contract research organization (CRO) based on Kolkata, West Bengal, providing clinical research services at a global level and ensures that a trial moves faster through the value chain and results in shorter timeliness to get to the market.  ]]> https://biospectrumindia.com/news/97/16595/syngene-ties-up-with-himedia-for-covid-19-elisa-test-kits.html https://biospectrumindia.com/news/97/16595/syngene-ties-up-with-himedia-for-covid-19-elisa-test-kits.html Wed, 03 Jun 2020 08:00:00 +0530 Syngene International Ltd., an integrated research and development services company, has entered into collaboration with HiMedia Laboratories, a bioscience company with expertise in media manufacturing and diagnostics for over 45 years, to manufacture and distribute its ELISA kits. HiMedia will manufacture the kits at its facility in Mumbai and distribute it across India. Syngene has indigenously developed an anti-COV-2 IgG ELISA (Enzyme-Linked Immunosorbent Assay) at its research facility in Bengaluru. This advanced highly reliable test identifies the presence of SARS-COV-2 antibodies in blood samples and confirms if a patient has been exposed to the coronavirus. It has a capacity to test samples together in a single run and generates results within 3 hours. Commenting on the collaboration, Dr Mahesh Bhalgat, Chief Operating Officer, Syngene International Ltd., said, “At a time when the number of COVID-19 cases is increasing at an alarming rate across the country, there is an urgent need to make available reliable testing kits using advanced technology to test patients and identify positive cases. To fill this gap, Syngene, with its expertise across diverse scientific domains, has developed an ELISA kit that allows higher throughput and generates faster results. We are happy to tie-up with HiMedia who will make the kits available at a large scale to significantly increase serological testing in India.” Dr. Vishal G. Warke, Director R&D, Cell Culture and Immunology, HiMedia Laboratories added, “We are happy to partner with Syngene in manufacturing and distributing their ELISA kits. This partnership brings together our mutual expertise in research and manufacturing and will further strengthen our fight against the COVID-19 pandemic.” As part of the collaboration, Syngene will initiate tech-transfer of the kits to HiMedia for developing the prototypes for submission to CDSCO for approval. HiMedia will launch the kits in two weeks after receiving the approval and market it under its brand name ELISafe 19. ]]> https://biospectrumindia.com/news/97/16581/rt-pcr-kits-by-igenetics-biogenomics-get-icmr-niv-approval.html https://biospectrumindia.com/news/97/16581/rt-pcr-kits-by-igenetics-biogenomics-get-icmr-niv-approval.html Mon, 01 Jun 2020 00:00:00 +0530 Adding to the arsenal of indigenous testing kits in India’s fight against COVID-19, Mumbai-based speciality diagnostic major iGenetic Diagnostics and Thane-based Biogenomics have jointly developed RT-PCR testing kits with 100 per cent concordance to true positives and true negatives and have received approval from the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The RT-PCR kit, considered to be gold standard for diagnosis of COVID-19, has been jointly developed by iGenetic & Biogenomics and Biogenomics is working on manufacturing and distribution across the country. The kits are expected to be available in the market within a few weeks. “India has already began testing 1 lakh people a day and our kits will offer a boost to the efforts of ramping up the testing capability further. The RT-PCR test kits have been approved after satisfying the stringent guidelines of ICMR and NIV that squeeze the chances of a false positive or a false negative to zero. These kits are better than global kits in terms of quality, adaptability, and price. Having a dependable kit developed in the country is crucial in these days of restricted movement, when global kits may not be easily available, to cater to the increasing demand, need to scale up production, and can be custom-made to suit the mutation of the virus in the Indian setting. We partnered with Biogenomics due to their extensive experience and expertise in manufacturing and marketing of biotechnology products, We have already received overwhelming interest and are exploring areas for ramping up,” said Arunima Patel, Founder & CEO, iGenetic Diagnostics. The availability of the kits will boost testing capabilities in the Bangalore which has 2283 of confirmed cases of coronavirus that has claimed 44 lives. iGenetic Diagnostics is a pioneer in developing in-house testing for various complex infections, including PCR tests for community-acquired pneumonia, TB, septicaemia, meningitis, and various CNS infections while Biogenomics is a young, rapidly-growing biopharmaceutical firm in Chennai with independent, high-quality research and manufacturing capabilities adhering to Current Good Manufacturing Practice (cGMP) regulations. As a partner to iGenetic, it will conduct further validation and testing of such kits in-house, and Biogenomics will exclusively obtain all licenses towards manufacturing and marketing this kit and manufacture, distribute, market, sell, recover dues, and conduct all commercial activities of the diagnostic kit. “We are proud to be able to join forces with iGenetic in this fight against a raging pandemic. As research-minded professionals, we recognise the value of iGenetic contribution and its importance. The production of the kits is going on with full steam ahead and these will be available for use in next few weeks,” said Dr Archana Krishnan, founder director of BioGenomics. iGenetic will continue to perform validations and/or testing of various batches of the kit as may be necessary and as per regulations or market requirements and will also support BioGenomics in any additional development work including but not limited to validations, testing of live samples and such other activities. “We have done extensive validation in-house while developing the kit – the design and development is an intricate process that requires significant expertise and resources. iGenetic successfully harnessed its expertise and deep knowledge base to design this test in-house with the highest degree of concordance. We are a leading name in the field of clinically relevant differential diagnosis and has been catering to patients across India for the last several years. All our laboratory facilities are NABL-approved and are spread out across the country in Maharashtra, Karnataka, Andhra Pradesh, Telangana, Delhi/NCR, Kerala, Tamil Nadu, Madhya Pradesh and Rajasthan,” added Patel. ]]> https://biospectrumindia.com/news/97/16566/govt-hospitals-should-ensure-elective-surgeries-are-resumed-in-earnest-mtai.html https://biospectrumindia.com/news/97/16566/govt-hospitals-should-ensure-elective-surgeries-are-resumed-in-earnest-mtai.html Fri, 29 May 2020 12:05:00 +0530 Medical Technology Association of India has sought the government’s intervention to ensure elective surgical procedures are resumed in earnest to pre COVID-19 level. This will enable hospitals to re-start their normal operations. The hospitals had to shut down their OPDs due to various government restrictions to control the spread of COVID19 pandemic, which severely impacted their revenue flow. Elective surgeries are planned procedures and were mutually postponed by hospitals and patients due to fear of COVID infection. Cases that were postponed included removal of malignant tumours, critical endovascular and peripheral vascular surgeries, chemotherapy, dialysis, hip replacement surgery, and cataract among others. With restrictions being eased out, hospitals have started making provisions for elective surgeries but patients are still reluctant to turn up for procedures due to fear of contracting the infection. Elective surgeries account for approximately 50% of revenues for hospitals in normal business conditions. Reduced revenues have curtailed hospitals’ ability to pay for supplies of pharmaceuticals, diagnostics and medical devices, thereby severely disrupting entire healthcare value chain. More than 5 lakh planned surgeries in India have been re-scheduled since the imposition of lockdown. The fall in revenue of hospitals is creating an unprecedented financial crisis for medical device sector due to delays in payment. Medical device companies are already dealing with an increase in operational expenses and limited availability of transportation and workers. This is further compounded by additional costs in complying with safety and hygiene standard operating procedures. Sanjay Bhutani, Director, Medical Technology Association of India said, “The healthcare sector is in dire need of support to resume services to the optimal level. One quick measure in the current circumstances is resumption of elective procedures at the earliest. Hospitals need to work in tandem with the government to start elective surgeries without compromising their capabilities to handle COVID-19 cases. Creation of a clear communication module is equally important in order to allay any fears in the minds of patients.” Governments of many countries including the US, Australia, Japan, Canada and Singapore have allowed elective surgeries after balancing the community's needs against the risk of infection of COVID19. The measures that they have put in place include: Adequate provisions to handle and treat COVID-19 cases in isolation. Adequate supply of PPEs, medications, ICU beds, and availability of human resources Prioritization of surgeries based on severity of illness. Regular screening of nonCOVID-19 patients and staff attending to them. Strict sanitation policies in both COVID-19 and nonCOVID-19 treatment areas. In addition to the above, hospitals in India should also devise a module to communicate all the safety and screening measures they have taken to patients to give them the required confidence to appear for treatment.   ]]> https://biospectrumindia.com/news/97/16553/iit-mandi-develops-low-cost-portable-ventilators.html https://biospectrumindia.com/news/97/16553/iit-mandi-develops-low-cost-portable-ventilators.html Fri, 29 May 2020 07:35:00 +0530 Indian Institute of Technology Mandi researchers have developed two low-cost portable ventilators. The developed prototypes are easy to use and can be taken to remote locations in case of a medical emergency. Wi-Fi Operated Smart Ventilator Dr. Arpan Gupta, Associate Professor, School of Engineering, IIT Mandi, along with research scholars, Lokendra Singh and Sourabh Dogra, have developed a smart ventilator costing only Rs 4,000. The developed prototype is a mechanised Artificial Manual Breathing Unit (AMBU) bag with options to control breath rate and volume of air going into the patient's lungs. The unique feature of the developed product is, apart from manual operation, it can be controlled by a mobile application over wifi as well. For the same, the smartphone application, ‘IIT Mandi Ventilator’ has been developed at IIT Mandi. This mobile application can start-stop the ventilator and change the Breath/ Minute (BPM) rate. The designed prototype uses a slider-crank mechanism to pump air and is easy to manufacture, assemble and operate. Speaking about the ventilator, Dr. Arpan Gupta said, “Designed especially for COVID-19 pandemic, this low-cost ventilator can be operated manually as well as using a smartphone app connected over Wifi. It can offer some protection to our medical staff, who can operate the ventilator remotely.” There is also an emergency switch on the ventilator and the mobile application that stops the ventilator and alarms in case of any malfunction. The ventilator can be directly operated with an AC supply or from an external battery. The present ventilator is for non-critical patients who need some help in respiration. The prototype was developed in consultation with a medical team consisting of Dr. Chander Singh, Medical Officer, IIT Mandi and Dr. Manjul Sharma and Dr. Jasdeep from Jagriti Hospital, Mandi. Low-cost Mechanical Ventilator Dr. Rajeev Kumar, Associate Professor, School of Engineering, IIT Mandi, along with his research team have developed a mechanical ventilator by using a low-cost self-inflating bag operated by an electric motor costing under Rs. 25,000.  The research team has used the motor generally used in an electric ventilator along with the Artificial Manual Breathing Unit (AMBU) bag or self-inflation bag to achieve the goal. In this ventilator, a single rack and pinion mechanism has been used in which the self-inflatable bag is compressed from one side that would blow the oxygen into the patient's lungs either through invasive or noninvasive mode. The developed ventilator has an interface between the ventilator to the patient and the ventilator to the operator. Speaking about the innovation, Dr. Rajeev Kumar said, "In this time of COVID-19 pandemic, this low-cost ventilator will be very useful especially for the rural patients because of its portability." Along with this, the ventilator is portable and has user-specified Breath/Minute (BPM), tidal volume and exhale-inhale time ratio facility. It also has a display of settings and status and alarms for high airway pressure. Such features are usually found in the ventilators which are much costlier than the developed prototype.     ]]> https://biospectrumindia.com/news/97/16561/nathealth-conducts-covid-private-sector-lab-survey-.html https://biospectrumindia.com/news/97/16561/nathealth-conducts-covid-private-sector-lab-survey-.html Thu, 28 May 2020 17:35:00 +0530 NATHEALTH has conducted a recent survey among 50 private laboratories across 13 Indian states to explore ways to enhance testing in private sector labs. Findings indicate that with the current testing scenario, while the public sector is running at nearly full capacity, the private sector is being utilized only at 25-30 %.  The surveyed labs are currently working only single shifts, doing cumulative 5,000 tests per day with 17 labs doing less than 100 tests per day and 6 labs not doing any testing at all. A mere 30% utilization of private labs also indicate demand flow as a challenge to enhance testing. The current testing regime prioritizes demand flow to public labs with only excess demand flowing to private labs. The current testing capacity in India stands at 150,000-170,000 tests per day with the public sector capacity at ~110,000 tests per day and private sector capacity at ~60,000 tests per day. Currently India is conducting 100,000 tests per day. A large portion of this is driven by public sector which conducts around 75,000 – 80,000 tests, while private sector conducts 15,000 – 20,000 tests per day. Private labs with support from central and state governments could quickly ramp up testing up to 4-6 times with double shifts. Lab operators also mentioned significant on the ground operational issues. 56% of the survey respondents face logistics challenges which can be solved by sample flow between districts & states to ensure better utilization. 54% face difficulties with guidelines and procedures that may be solved by standardization of forms and simplified approval processes for sample collection. 24% face pricing and commercial solution for which lies in expedited payments to tide over immediate liquidity challenges and consolidated procurement of consumables/ kits. The respondents to the survey highlighted that support is needed across Central and State Governments to ramp up testing. There is a potential to increase the testing capacity by 6 times through better utilization and 2-shift operations in private labs. Improving existing capacity utilization to 80% will increase testing to 14,000 tests per day assuming 1 shift operation. Additionally, increasing shifts to 2 will increase testing by 30,000 tests per day. We need to act now with cases expecting to peak further by mid-June 2020.  The survey also indicates three key themes that require intervention to ramp up testing and reduce COVID19 infections: Coordinated Operations support Consider consolidated procurement to manage costs Standardize one data entry format across Center / State Streamline sample collection approval Single window resolution of operational issues Demand flow Demand flow currently directed predominantly to public labs. Consider private labs as active parts of the testing regime rather than just overflow capacity Resolve inter district/ inter-state logistics and testing to enhance utilization Explore private labs for antibody tests in future Liquidity and standardized Pricing Guidelines On time payments for government directed testing to support cash-flow; Standardize NHA prices across states for testing for government directed tests   ]]> https://biospectrumindia.com/news/97/16554/smt-acquires-vascular-concepts-.html https://biospectrumindia.com/news/97/16554/smt-acquires-vascular-concepts-.html Thu, 28 May 2020 13:45:00 +0530 SMT (Sahajanand Medical Technologies Pvt Ltd) announces its entry into the structural heart segment with an acquisition of medical device firm Vascular Concepts. The acquisition got completed recently.   Even after acquisition, Vascular Concept will retain its distinct brand and independence. Swaminathan Jayaraman, CEO of Vascular Concepts will continue to manage the operation of the company. Vascular Concepts Group comprises of two entities, based in India and Thailand. This medical device firm has more than 200 employees, two manufacturing setups and two research and development centres and has a diversified product portfolio which includes coronary stents, cardiac closure devices, peripheral stents, unique balloon catheters like PTMC balloons and TAVI. Vascular Concepts has developed and launched the Hydra transcatheter aortic valve system, which received Indian regulatory approval in 2020. It is used for the treatment of high-risk patients suffering from severe and symptomatic aortic valve stenosis. The Hydra TAVI system is a self-expanding supra-annular transcatheter aortic valve, which presents unique design features and similar event rates compared to contemporary devices in separate clinical studies conducted in India and Europe. The TAVI market is growing at about 20% worldwide, Europe and the US being the main markets to date. Speaking about the combined operational strength and new entry; Dhirajlal Kotadia, Chairman of Sahajanand Group, said, “Structural heart segment is a fast-growing segment in cardiovascular industry. We strongly believe that SMT will play a major role within this segment and provide solutions to benefit patients and its wide customer base. Acquisition of Vascular Concepts Group reflects our commitment to become a leader in TAVI and structural heart technologies. TAVI is an innovative solution and will help carry forward our motto of – ‘Pledged to save millions’.” Commenting on the acquisition, Swaminathan Jayaraman CEO & MD of Vascular Concepts Group added that, “We are excited to join hands with SMT, who have a strong leadership in interventional cardiology and has demonstrated aggressive growth in this business. This association will create tremendous market opportunities for both companies to grow in Structural Heart Disease. Vascular Concepts is committed to driving further innovation in the field of Structural Heart which can be commercialized together with SMT.”    With an addition of aortic valve to its product categories, SMT advances in its mission to provide cardiac care to the healthcare community and patients.       ]]> https://biospectrumindia.com/news/97/16540/csir-reliance-team-up-for-covid-19-detection-test.html https://biospectrumindia.com/news/97/16540/csir-reliance-team-up-for-covid-19-detection-test.html Wed, 27 May 2020 10:10:00 +0530 As part of COVID-19 mitigation mission of Country, CSIR has strategized its R&D to develop, integrate, scale-up, and deploy necessary technological interventions for combating Coronavirus pandemic in the country. Considering the multifarious problems created by coronavirus, which require interventions, the CSIR under the guidance of its Director General, Dr. Shekhar Mande has formed five verticals to coordinate various research activities into Digital and Molecular Surveillance, Drugs & Vaccines, Rapid and Economical Diagnostics, Hospital Assistive Devices & PPEs, and Supply Chain and Logistics.  Since testing is vital component in COIVD-19 mitigation, CSIR-IIIM, Jammu a constituent laboratory of CSIR has partnered with Reliance Industries Limited (RIL) to develop and scale-up a new Reverse Transcriptase-Loop Mediated Isothermal Amplification (RT-LAMP) based COVID-19 diagnostic kit for which a formal MOU has also been signed between CSIR-IIIM, Jammu and RIL. COVID-19 RT-LAMP test is a nucleic acid based test carried out from nasal/throat swab sample from patients. The test recipe has been developed and successfully demonstrated using synthetic templates. It is rapid (45-60 min), cost effective and accurate test.  It has been tested with a small number of patients samples and validating the kit on more number of patient samples is planned and will be done together with RIL. The advantage of this test is that the RT-LAMP based COVID-19 kit components are easily available and these can be completely manufactured in India.  While the, the current COVID-19 testing is done by real-time PCR their components are mostly imported. Further these tests are expensive; require highly trained manpower, costly instruments and a relatively high-end lab and cannot be deployed at remote locations in quarantine centers, airports and railway stations, etc. On the other hand, the RT-LAMP test can be done in a single tube with minimal expertise in a very basic lab setup like mobile units / kiosks for testing at Airports, Railway Stations, Bus Stands and other public places. The end detection of the test is a simple colored reaction, which is easily visible in UV light, and now is being modified such that it can be detected in regular light. After testing the accuracy of the kit, on a much larger number of patients, CSIR-IIIM and RIL will jointly approach ICMR for approval. RIL plans to rapidly scale up the tests for the larger population and use it for easy, rapid and widespread diagnosis for COVID-19 detection for the larger interest of society. With the formal launch of the RT-LAMP based diagnostic test, the COVID-19 testing will not only be more rapid, cheap, easy and accessible but also would go a long way quickly isolating the infected individuals and mitigating the spread of virus.  Dr. Ram Vishwakarma, Director and Dr. Sumit Gandhi, Principal Scientist from CSIR-IIIM and Dr. Santanu Dasgupta, Senior Vice President, R&D and Dr. Manish Shukla, General Manager R&D from RIL side are monitoring this project. ]]> https://biospectrumindia.com/news/97/16533/tcl-segun-to-launch-ir-thermometers.html https://biospectrumindia.com/news/97/16533/tcl-segun-to-launch-ir-thermometers.html Tue, 26 May 2020 13:25:00 +0530 Delhi based Segun Life, a homegrown brand in wearables and healthcare devices working towards various COVID-19 Helplines and non-profit initiatives, has partnered with TCL to launch infrared thermometer to aid COVID-19 in India. The thermometer comes with HD LCD display with vibration alert and accurate ergonomic measurements. The thermometer is non-touch 3-in-1 digitally equipped for different levels of temperature. It can measure temperature in the room for food, objects and liquids also. The device comes with no-touch digital sensors to measure temperature from a distance to avoid contact risk. It is provided with a switch option between Celsius and Fahrenheit. The non-touch 3-in-1 digital infrared LED changes its colour basis temperature between High, Normal and Low. It changes backlight colour while detecting fever to red. The thermometer is equipped with high accuracy ergonomic and automatic power-off features. The detection time is 1 second. The LED comes in three colours white, Green and Red. On the launch, David Huang, Senior Vice President, TCL says, “We are delighted to partner with Segun Life at this hour where there are massive requirements for these sensor thermometers. Through this strategic partnership, we are looking forward to serving customers with the best innovation at an affordable price bracket.” CP Khandelwal, CEO - PR innovations (Managing Business SegunLife) says, “To serve people with the best innovations, we have partnered with TCL to make sure people should get the best quality products at a promising price bracket. The newly launched IR thermometer is equipped with the latest features of the LCD screen and high accuracy measurement. Consumers have always accepted our products, and like earlier, we are hoping for the same kind of response from them.”   ]]> https://biospectrumindia.com/news/97/16531/sterling-accuris-receives-icmr-approval-for-covid-19-testing-in-delhi-lab.html https://biospectrumindia.com/news/97/16531/sterling-accuris-receives-icmr-approval-for-covid-19-testing-in-delhi-lab.html Tue, 26 May 2020 08:05:00 +0530 Being one of the fastest-growing pathology laboratory chains in India and having the widest network of labs in Gujarat, Rajasthan and MP, Sterling Accuris Diagnostics has received the prestigious approval from the regulatory body ICMR for its lab in Delhi to do COVID-19 testing.  The lab in Delhi had only recently received National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation. With this approval Sterling Accuris Diagnostics - Delhi will be able to cater to the patients from NCR and other underserved regions in North India for Covid-19 testing. The lab already performs variety of tests ranging from routine CBC to high end Molecular tests.  Speaking on the achievement, Dr. Prashant Nag, Centre Head & Sr. Pathology Consultant, Sterling Accuris Diagnostics said, “With this authorisation, Sterling Accuris Diagnostics Delhi is well poised to join the league of pathology labs; capable, competent and credible to facilitate COVID -19, Swine Flu and other molecular-based tests. More importantly, we have highly qualified frontline and technical team, coupled with state-of-the-art equipment.” Rajiv Sharma, Group CEO & MD, commented, “Our Delhi based pathology Lab has become the fifth lab in our group to get NABL accreditation for maintaining highest quality standards and procedures for testing. With this approval from ICMR, we plan to expand our operations in Delhi to accommodate the growing need for high end pathology tests including COVID -19 testing. Ankush Gupta, COO and Director, Sterling Accuris Diagnostics said, “At present, the Indian Pathology industry is observing a huge transition with the need for more NABL accredited labs for conducting extensive specialised testing like COVID -19, abiding the ICMR guidelines and protocols. Being a core believer of high-quality pathology services, we are extremely delighted to have received the prestigious NABL accreditation and ICMR approval for our lab. This will reinforce the trust and confidence of our customers.” ]]> https://biospectrumindia.com/news/97/16528/india-invites-rs-70000-cr-investment-in-medical-devices-sector-aimed.html https://biospectrumindia.com/news/97/16528/india-invites-rs-70000-cr-investment-in-medical-devices-sector-aimed.html Tue, 26 May 2020 07:15:00 +0530 A webinar on ‘Medical Devices and API sector: Challenges & Emerging Opportunities’ was held on 22nd May, 2020 for business and trade collaboration between India and Japan in the post COVID-19 scenario. The webinar was organized by the Embassy of India, Tokyo in partnership with the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India at the initiative of Ambassador HE Sanjay Verma & AiMeD (Association of Indian Medical Devices Industry) Sanjay Kumar Verma, Ambassador of India to Japan shared his thoughts on the golden opportunity for India and Japan to further boost their relationship in the context of the ongoing COVID-19 crisis. Dr. P. D. Vaghela, Secretary, Pharmaceuticals presented the sectoral view and the investment opportunities in the pharmaceutical and medical device industry in India. He also presented various initiatives taken by the Government of India to promote trade and business in the country. Navdeep Rinwa, Joint Secretary, Pharmaceuticals explained the Department’s schemes to promote manufacturing of bulk drugs and medical devices viz. Production Linked Incentive schemes and Promotion of Bulk Drug/Medical Devices Parks and requested the delegates to avail benefits of the schemes. Pharmaceutical Traders Association and Japan Federation of Medical Devices Associations deliberated on the Post COVID-19 challenges & opportunities for Pharmaceutical & Medical Device sectors and its impact on the global supply chain and suggested that cooperation between the two countries can contribute to stabilize the supply-chain of especially APIs and Medical Devices. Representative of JETRO Chennai also shared insights on challenges and emerging opportunities in API sector and Medical Devices. Mona K C Khandhar, Minister (Economic & Commerce), EoI, Tokyo mentioned about the resilience and strength of the Indian economy and detailed on the stimulus & reform packages announced by the Government of India to address the COVID-19 crisis and to improve the investment environment. The advantages of Indian economy, FDI ecosystem & Japan specific facilitation were also mentioned. Representatives of Japanese subsidiaries Nipro India Corp and Eisai Pharmaceuticals India Pvt Ltd shared a detailed presentation and their experience about ‘Make in India’ program. Representatives of major Indian Pharmaceutical and Medical Device Associations presented the future growth opportunities and way forward for Pharmaceutical and Medical Device industry in India. Overwhelmed by the interest expressed by Japan’s Medical Device Industry, Rajiv Nath Forum Coordinator, AiMeD on behalf of Indian Medical Devices industry invited Japanese investors in the field of Medical Device (including Medical Electronics & IVD) who are interested to set up Manufacturing base in India via Technical Collaboration with Japanese MSME Joint Venture with Japanese SME 100% Direct Investment by Large Company Licensing of Technology / Patent by MSME “We invite Japanese expert manufacturers to teach us & partner with Indian and be a part of India’s upcoming big story in global Medical Devices sector. Let us replicate the success of Automobile & IT industry”, said Mr. Nath.  India imported 544 Billion Yen (38800 Cr ₹) of Medical Devices in 2019 & exported178 Billion Yen (12700 Cr ₹) of Medical Devices with market size at Retail & Institutional sales level of over 1500 Billion Yen (1,05, 000 Cr₹). India has Potential for over 1000 Billion Yen (70,000 Cr ₹) investment in Medical Devices over next 5 years. India is targeting 1200 Technical Collaborations with Indian Investors for 600+ Billion Yen, 200 Joint Venture by Overseas Foreign Investors for 200+ Billion Yen and 50 MNC’s for 200+ Billion Yen. Last month , the Indian Med Devices Industry had requested Indian Ambassador to invite Japanese Inc to shift Factories from China to India for enabling actual Make in India instead of spending over 200 million $ to assist them to shift elsewhere and suggested that  Indian Govt. can possibly offer to subsidize by 100 Million $ this shifting. “The Dark Cloud of COVID has one Silver Lining - Make in India of Medical Devices has become a valued entity as the few factories that are there, not only took up the challenges to meet the demands of the buyers in scenario of disrupted supplies, of the 85% import dependent market but are being looked at globally as possible 2nd factory to the World after China”, said Mr. Nath. In his presentation Mr Nath explained the potential Japanese Collaborators that the business environment in India is changing to bring in a new era to boost Manufacturing of Medical Devices with the following measures having been taken in last 2-3 years : a) Correction of Inverted Duties for 78 Devices on January 19th, 2016 & 5% Cess added on to Basic Duty on 01.03.2020. b) Launch of ICMED Quality Assurance Certification by QCI c) Medical Device Regulatory Framework, separately from Pharma being implemented in phases by MoH&FW. d) Central Govt. and State Govt. are creating Medical Device Parks with Common Manufacturing Facility to create a conducive cost-effective Manufacturing Environment e) A Preferential Market Access Policy to protect investments and support Indigenous Manufacturing under Make in India Public Procurement Order. f) India Invest providing facilitation services to investors as Make in India enablers Representatives of State Governments of Gujarat, Telangana, Himachal Pradesh and Goa offered finer details of the investment opportunities in their respective States including package for incentives and taxation benefits, ease of doing business initiatives, land availability, infrastructural facilities, regulatory framework and invited Japanese companies for investing in their respective States. Representatives of Andhra Pradesh MedTech Zone, SMT Technologies, Allengers, Transasia, Trivitron, Hindustan Syringes & Medical Devices Ltd and Wockhardt, Sun Pharma, Panacea Biotec in Pharma Sector and other large number of Japanese companies also participated in the webinar as part of G2B and B2B networking.     ]]> https://biospectrumindia.com/news/97/16523/icmr-validates-truenat-test-for-covid-19-diagnosis.html https://biospectrumindia.com/news/97/16523/icmr-validates-truenat-test-for-covid-19-diagnosis.html Mon, 25 May 2020 09:05:00 +0530 The Indian Council of Medical Research (ICMR) had earlier validated the indigenous TrueNat assay for Tuberculosis. The test is WHO pre-qualified and is included as a reliable and accurate method for quick screening of TB patients. The TrueNat assay has also been validated by ICMR-NIV as a point of care test for Nipah virus disease. In April 2020, the indigenous manufacturer developed TrueNat assay for screening of SARSCoV-2, causing COVID-19. ICMR undertook successful validation of the E gene screening assay, following which TrueNat based testing has been initiated by the states for SARS-CoV2 detection. From April 2020 till date, more than 1.3 lakh screening tests have been conducted by states. However, the rate limiting step has been the lack of TrueNat confirmatory assay. All the TrueNat positive samples had to be confirmed by RT-PCR based tests either located in the same or different laboratory. Recently, the indigenous manufacturer has also developed a RdRp gene based confirmatory assay of TrueNat which has been successfully validated again by ICMR and has been found to have high sensitivity and specificity. Both the validations have been stringently conducted by DHR/ICMR Virus Research & Diagnostic Laboratory (VRDL) at Bangalore Medical College & Research Institute, Bengaluru. ICMR has now recommended the TrueNat COVID-19 test as a two-step test: step one i.e. E gene screening assay for all COVID-19 suspect samples to be followed by step two for the RdRp based confirmatory test in all E gene positives. This fully indigenous diagnostic platform offers a reliable and affordable option to augment the SARS-CoV-2 testing capacity in India. The platform comprises of a TrueNat machine, inbuilt RNA extraction system, RT-PCR chips, collection swabs and viral lysis medium (VLM). Single assay has a turnaround time of 35-50 minutes for 1-4 samples with a total of 12-48 samples being tested per day, depending upon the type of machine. The biosafety and 2 | P a g e biosecurity requirements are minimal in view of the sample being collected in viral lysis medium (VLM), which inactivates the virus. The test can be used at the level of district hospital/ Primary health centers also. ]]> https://biospectrumindia.com/news/97/16513/medgenome-strengthens-presence-in-infectious-disease-testing.html https://biospectrumindia.com/news/97/16513/medgenome-strengthens-presence-in-infectious-disease-testing.html Fri, 22 May 2020 06:10:00 +0530 MedGenome Labs Ltd collaborates with Dr Iravatham’s clinical laboratory at Hyderabad to enhance the Tuberculosis diagnostics offering and gets ICMR approval for RT-PCR testing for COVID-19 with its current partner XCyton Diagnostics One of the biggest problems that Indian has faced in the field of Healthcare is in the area of infectious diseases. Before COVID-19 was recognised as a global pandemic, India was at the centre of the discussion on reducing global tuberculosis burden. With an immensely high prevalence of tuberculosis in India, the world is looking towards India to control the same. Indian government has set a deadline of ending TB by 2025. While India is one of the highest contributor to the global TB burden, the same nation, on the other hand, is looked upon as a proactive decision maker as far as controlling COVID-19 spread is concerned. However, There are reports that show how the COVID-19 lockdown is taking us back to 2013 as far as our fight against TB is concerned. The lockdown may aggravate the existing TB burden as more TB patients may go undiagnosed and hence untreated. With both these public health issues in focus, MedGenome Labs, India’s biggest genetic diagnostics lab collaborates with Dr. Iravatham’s clinical laboratory in Hyderabad, a niche testing lab in the field of Tuberculosis diagnostics strengthening its presence in infectious diseases testing. MedGenome’s partner Xcyton Diagnostics is also awarded the ICMR approval to undertake COVID-19 testing at its lab in Bengaluru. Citing their strengths, Dr. Vedam Ramprasad, CEO, MedGenome Labs, said “Our collaboration with Dr. Iravatham’s lab is a milestone in TB testing ecosystem and we are committed to take more steps to integrate SPIT SEQ, our proprietary whole genome sequencing based test for diagnosis and drug resistance detection directly from sputum samples, into TB testing ecosystem”. The partnership with Iravatham’s lab will help integrate MedGenome’s flagship innovation SPIT-SEQ, with various tests offered by Dr. Iravatham for Tuberculosis and also set up a state of the art BSL2/3 infectious testing lab in Hyderabad “With India in the limelight as far as global TB burden is concerned, diagnosis and drug resistance detection take the centre stage. Offering a complete range of tests, right from smear microscopy to a sequencing-based test, will help shorten the time to diagnose, and lead to timely intervention.”, said, Dr Chitra Iravatham, Dr Iravatham& Clinical Laboratory (DICL) Dr BV Ravikumar, Founder and Managing Director, XCyton Diagnostics Ltd said, “We are equipped to undertake a minimum of 1000 tests per day, with an ability to scale up the capacity manifolds in a matter of a few days. We are strongly looking at making an impact and help India fight COVID-19”. MedGenome is the current market leader in this industry to have studied genetic disposition in multiple therapy areas like Cancer, Reproductive Health, TB, Rare Diseases amongst others in the country. Currently, the tests by MedGenome are recommended by over 1600 hospital networks and clinics in India. ]]> https://biospectrumindia.com/news/97/16498/cpc-diagnostics-launches-covid-19-clia-ab-tests-in-india.html https://biospectrumindia.com/news/97/16498/cpc-diagnostics-launches-covid-19-clia-ab-tests-in-india.html Thu, 21 May 2020 09:05:00 +0530 CPC Diagnostics , Chennai, a portfolio company of Everstone backed healthcare platform Everlife Holdings Pte. Ltd, has launched SARS COV-2 IgM and SARS COV-2 IgG tests in India. Both are CE-approved antibody tests and are the first of their kind to get approved by the Indian Council of Medical Research (ICMR). The Chemiluminescence immunoassay (CLIA) based tests, developed by Shenzhen-based YHLO Biotech Co. Ltd, run on the fullyautomated analysers iFlash 1800/3000, offering sensitivity of 97.3% and 86.1% for IgG and IgM with specificity of 96.3% and 99.2% respectively. The IgM assay is capable of detecting the disease as early as the 7th day after infection. The iFlash system minimizes human error, while being able to handle large volumes. Depending on the analyser model, a lab can report up to 1000 to 2000 results per day on a single instrument, with the flexibility for facilities to add further modules to ramp up output substantially. CPC is also planning to launch another antibody testing solution that is ELISA-based, which is under the process of ICMR approval. The ELISA tests developed by EUROIMMUN AG in Germany can be programmed on any automated ELISA processor or ELISA reader in addition to the dedicated EUROIMMUN analysers. These tests offer high sensitivity of 93.8% and 100% for IgG and IgA with specificity of 99.3% and 90.5% respectively. ]]> https://biospectrumindia.com/news/97/16501/the-growing-concern-of-inflammatory-bowel-disease-in-india.html https://biospectrumindia.com/news/97/16501/the-growing-concern-of-inflammatory-bowel-disease-in-india.html Wed, 20 May 2020 00:00:00 +0530 Wellness 365, a community representing leading Indian medical professionals and practitioners, today announced that India today has an estimated 1.5 million patients affected by the Inflammatory Bowel Disease (IBD), putting the country second only to USA with 1.6 million patients. Also, these number are rising at a high single digit rate, as Indians have a greater than average risk of getting this disease.  To educate people and help them receive appropriate medical intervention, the platform today launched a month-long campaign #ManageYourIBD, in association with leading Indian gastroenterologists from the key metro cities. The campaign was launched in support of the May 19, 2020, the World IBD Day. This will complement the global movement with hashtag #MakeIBDwork.  Inflammatory Bowel Disease is an intestinal disorder which involves prolonged inflammation of the digestive tract and if left untreated can lead to irreversible damage of the intestines involving conditions like intestinal obstruction, intestinal perforation, and a higher risk of colorectal cancer. IBD is not cured by regular medication and requires the involvement of a specialist often requiring long-term management. Broadly there are two types of IBD’s - Ulcerative Colitis (UC) and Crohn’s Disease (CD).  Explaining the symptoms, Dr. Rudrajit Sinha, Gastro-Intestinal Surgeon, Advanced Laparoscopy & Robotics, The Calcutta Medical Research Institute, Kolkata, says, “An IBD patient suffers from persistent abdominal cramps with irregular bowel habits and occasional passage of mucus and blood in stools. The disease is often associated with unexpected weight loss and the patient is resistant to usual treatments for stomach ailments.”  The diagnosis for IBD’s can be challenging, explains Dr. Ajay Choksi, Consultant and Head , Dept. of Gastroenterology, Nanavati Hospital, Mumbai “Many self-limited illnesses like bacterial infections and protozoal illnesses can mimic IBD on gross endoscopic and histologic findings but do not last beyond a month. Very often it may be impossible to differentiate between tuberculosis and Crohn’s disease which is when therapeutic trials and follow ups may be required for a precise diagnosis. Timely and early diagnosis increases the probability of inducing easy and durable remission of the disease. Vast majority of the patients can be successfully managed with medications.”  Elaborating on the risks and the available treatment options, Dr. Ajay Bhalla, Director & Head Gastroenterology, Fortis Hospital, Noida, says “Medical management remains the key modality in the treatment of inflammatory bowel diseases. In case of ulcerative colitis, need for surgical intervention is low at about 6% for Indian patients while the worldwide average being about 10-12%. Medical management with drugs like 5-ASAs, steroids and azathioprines and use of biologics gives effective outcomes.”  “However, in case of Crohn’s disease, the patient can end up with conditions like intestinal crystallization or recurrent obstruction, where surgery may be required. It is seen worldwide and in India too that about one third of patients with Crohn’s disease require surgery at some point of time.  Rest of the patients are successfully managed with medical management through drugs like steroids and azathioprines and now the use of biologics which would change the whole course of treatment. As the use of biologics becomes more common in India, I guess the requirement of surgery will go down further.”, he added.  Delving into the impact of the disease, if it is left untreated, Dr. Amarender Puri, Vice Chairman, Institute of Digestive and Hepatobiliary Sciences, Medanta, Gurugram, “There is a definite risk of colorectal cancer if IBD is left untreated. The risk is in direct proportion to the duration of the disease. It is negligible during the first 8-10 years but steadily increases thereafter. Currently the risk is thought to be about 10% among those with the disease for 25-30 years. This risk is particularly much more among patients who have been irregular with their treatment vis a vis those who are fully compliant. Additionally, untreated disease leads to long standing anaemia and protein loss from the body.”  Interestingly, factors like the socioeconomic and demographic classification play a role in the incidence of the disease, explains Dr. Piyush Ranjan, Sr. Consultant, Institute of Liver Gastroenterology & Pancreatico Biliary Sciences, Sir Ganga Ram Hospital, Delhi, “In general, IBD is more common among urban population and the higher socioeconomic groups. Both males and females have an equal chance of having ulcerative colitis. However, in case of Crohn’s disease, females have a slightly higher preponderance. “  Lack of awareness makes things worse: Lack of awareness remains a key barrier in helping people get the correct diagnosis and receive the right treatment. Ignorance often leads to the patient being treated for common problems like upset stomach, and even tuberculosis, while the issue is completely different. The debilitating effects of not diagnosing early is a life-threatening hazard which is also financially and emotionally draining for the family. Heightened awareness and early diagnosis can go a long way in helping people with the IBD conditions. ]]> https://biospectrumindia.com/news/97/16485/bbc-launches-covid-19-detection-kit.html https://biospectrumindia.com/news/97/16485/bbc-launches-covid-19-detection-kit.html Tue, 19 May 2020 12:00:00 +0530 Deputy Chief Minister of Karnataka and Minister of IT, BT and S&T, Dr C N Ashwathnarayan visited Bangalore Bioinnovation Centre (BBC) on 14th May 2020 and chaired the meeting regarding projects of COVID-19 diagnostics and therapeutics going on within the facility. He also launched automated RNA isolation and isothermal amplification kit for COVID-19 developed jointly by BBC and SN Lifesciences incubated at BBC. He mentioned “BBC has emerged as pioneer and top most institution of innovation and product development”. Dr C N Ashwathnarayan asked the IT/BT department to set up a committee to ensure co-ordination between the government and private firms that are engaged in research work to come up with solutions to control the spread of Covid-19 as well as a cure for it. He interacted with the young entrepreneurs and remarked "I am glad that all start-ups in BBC are working to find a solution to the pandemic. Some are at clinical trial stage while a few have already applied for with the competent authorities for conducting tests’’. "This is a great sign for Bengaluru, Karnataka and India. A quick solution will help ensure a balance between life and livelihood," he added. Managing Director - BBC, Dr Jitendra Kumar, informed that at least five more such products are ready for launch. ]]> https://biospectrumindia.com/news/97/16481/aatma-nirbharta-in-medtech-need-more-measures-mtai.html https://biospectrumindia.com/news/97/16481/aatma-nirbharta-in-medtech-need-more-measures-mtai.html Mon, 18 May 2020 13:15:00 +0530 The government has expressed its intention to create a surplus capacity in healthcare infrastructure. The plan to increase public expenditure on healthcare and ramp up health and wellness centres in remote areas will certainly help the needy in availing health services, especially since India’s spend on healthcare is only 1.3 percent of its GDP and needs severe bolstering. There is a need to carve out a concrete plan on building healthcare infrastructure at tertiary levels both in the government & private sectors, create more diagnostic centres and increase procurement of antibiotics, medical devices etc.  The entire healthcare continuum from providers to medical device suppliers have been hit by cash crunch due to increase in import duty, rupee devaluation against dollar, increased transport cost in the COVID situation due to surge prices, reduced cash flow due to non-payment of dues  and decrease in revenue due to stoppage of elective procedures. We urge the government to provide some relief and help the healthcare sector sustain in these testing times. Medical Technology Association of India (MTaI) believes that spending on healthcare can increase GDP by increasing productivity with reduced loss of man-days due to sickness. Also healthcare investment can increase employment opportunities in service provider segment like hospitals with increased number of clinicians/paramedics/ nurses. The employment opportunities in the industries supporting it like medical technology and pharmaceuticals will also be increased with more spend on manufacturing, supply chain and R&D. It is clearly established that countries with higher spend on healthcare have better per capita income with higher productivity. Pavan Choudary, MTaI Chairman and Director General said, "In our opinion, Aatma Nirbharta (self- reliance) in medical technology sector would be achieved, when we can make competitive products in India, when People of India can be treated in India without having to travel abroad & spending precious foreign exchange, when the tertiary care facilities will expand in the government sector too, when R&D flourishes to handle our problems as well as respond to global opportunities, when every Indian healthcare workers gets trained as well as his best global counterpart.” MTaI requests the Government to: Commit a definitive package on developing healthcare infrastructure and procurement and to increase fiscal spend to 2% of GDP in 2020-21 and 3% by 2021-22. Announce special fiscal package to release all pending payments to maintain cash flow to the providers and suppliers. Increase patient affordability by reducing customs duty, health cess and GST on medical devices which cannot be made in India in the short and medium term, with a view to handle the Covid crisis. Restart the elective surgeries in all zones, with special initiative for transportation of patients and ensuring stringent safety guidelines. Bring down aviation fuel cost, so that cost of logistics in shipping devices across the country is reduced.     ]]> https://biospectrumindia.com/news/97/16454/govt-dedicates-cobas-6800-machine-for-covid-19-testing.html https://biospectrumindia.com/news/97/16454/govt-dedicates-cobas-6800-machine-for-covid-19-testing.html Thu, 14 May 2020 16:40:00 +0530 Dr. Harsh Vardhan, Union Minister of Health & Family Welfare visited the National Centre for Disease Control (NCDC) and dedicated the COBAS 6800 testing machine to the nation. This is the first such testing machine that has been procured by the Government for testing of COVID-19 cases and is installed at the National Centre for Disease Control. The Union Health Minister also visited the Control Room and the Testing Laboratories, and reviewed the current status of COVID-19 testing with Dr S K Singh, Director (NCDC) and senior officials. Highlighting the achievements in ramping up the testing capability, Dr. Harsh Vardhan said, “We have now developed a capacity to conduct 1,00,000 tests per day. Today marks an important milestone as we have tested nearly 20 lakh tests for COVID-19 mark at more than 500 laboratories including 359 Government laboratories and 145 private laboratories in the country”. He further added, “NCDC has been now equipped with the COBAS 6800, a fully automated, high end machine for performing real time PCR testing COVID-19 in the service of nation. COBAS 6800 will provide quality, high-volume testing with a high throughput of test around 1200 samples in 24 hours. It will largely increase the testing capacity with reduction in pendency.” Highlighting its other features, Dr. Harsh Vardhan said that COBAS 6800 is a sophisticated machine enabled with robotics that minimizes the chance of contamination as well as the risk of infection to the health care workers since it can be operated remotely with limited human intervention. As the machine requires a minimum BSL2+ containment level for testing, it cannot be placed at just any facility. COBAS 6800 can also detect other pathogens like Viral Hepatitis B & C, HIV, MTb (both rifampicin and isoniazide resistance), Papilloma, CMV, Chlamydia, Neiserreia etc. The Union Health Minister emphasised on the quality and sturdiness of the community surveillance and contact tracing. ]]> https://biospectrumindia.com/news/97/16447/csir-nal-develops-non-invasive-ventilator.html https://biospectrumindia.com/news/97/16447/csir-nal-develops-non-invasive-ventilator.html Thu, 14 May 2020 09:05:00 +0530 CSIR - National Aerospace Laboratories (NAL) Bangalore, a constituent of lab of CSIR has developed a Non Invasive BiPAP Ventilator in a record time of 36 days to treat COVID-19 patients. BiPAP Non-Invasive ventilator is a microcontroller-based precise closed-loop adaptive control system with a built-in biocompatible “3D printed manifold & coupler” with HEPA filter (Highly Efficient Particulate Air Filter). These unique features help to alleviate the fear of the virus spread. It has features like Spontaneous, CPAP, Timed, AUTO BIPAP modes with provision to connect Oxygen concentrator or Enrichment unit externally.  The system has been certified for safety and performance by NABL accredited agencies. The system has undergone stringent biomedical tests and beta clinical trials at NAL Health Centre. The major advantage of this machine is that it is simple to use without any specialized nursing, cost effective, compact and configured with majority of indigenous components. This is ideal for treating COVID -19 patients in Wards, Make shift Hospitals, dispensaries and home in current Indian COVID 19 scenario.CSIR-NAL is in process of taking it forward with the regulatory authorities for the approval and expected to get shortly. CSIR-NAL has already initiated dialogue with major public/private industries as a partner for mass production.     ]]> https://biospectrumindia.com/news/97/16425/genei-labs-makes-versatile-covid-19-test-kit.html https://biospectrumindia.com/news/97/16425/genei-labs-makes-versatile-covid-19-test-kit.html Wed, 13 May 2020 08:25:00 +0530 Genei Laboratories Pvt Ltd, a Bengaluru based Bio-Tech company is gearing up for mass production of testing kits in collaboration with AMTZ, Vishakhapatnam. The technology is developed by Indian Institute of Technology (IIT)-Delhi and has been approved by the Indian Council of Medical Research (ICMR) for its Probe-less RT-PCR- based diagnostic assay. The testing method, developed by researchers at IIT Delhi’s Kusuma School of Biological Sciences has received ICMR’s validation for a sensitivity and specificity of 100%. This is the first probe-free assay developed for Covid19 and it can be extremely useful for high throughput screening with high specificity. Since fluorescent probes are not required for this assay, the kit will be manufactured locally with indigenous reagents and manufactured at Genei Laboratories, a company known for making molecular biology reagents since 1989 in India. The absence of vaccine to COVID19 means we have to ramp up our testing capacities as well as increase the capacity of the existing health infrastructure. Studies project that India alone would need 47.4 Crore test kits by end of July and this is only possible if the manufactuting and testing is decentralized at the state or the district level. Genei Laboratories has taken a step to address this issue as the technology used in the kit doesn’t require additional calibration for different probes. Hence, all the readily available qPCR machines can be directly used for testing. This is an effort to further democratize India’s fight against COVID19 allowing several research labs, diagnsotics and even colleges having qPCR machines to be roped in for screening in large scale and reliable manner costing much lesser than what is being charged currently. The large scale assembly and manufacturing of the kits is carried out at a cGMP facility exclusively set up for COVID-19 testing kits at Andhra Pradesh MedTech Zone, Vishakhapatnam. “AMTZ which is an eco-system to translate innovative products into business production units, is the ideal location to bring the science of IIT Delhi, the production engineering of Genei and the Infrastructural bandwidth of AMTZ” says Dr. Jitendar Sharma, MD & CEO-AMTZ. The researchers at IIT Delhi hope that this kit may be able to service large sections of the population. “We are delighted to enter into a partnership with IIT Delhi for further development and commercialization of this unique detection assay for COVID-19. Using their unique technology and our expertise in reagent and kit-making, we will ensure an accurate, affordable, Make-in-India kit for the diagnosis of Sars-CoV2," said Dr. S Chandrashekaran, MD, Genei Laboratories. Further, Genei Laboratories expects to manufacture the most affordable real time PCR testing Kits for COVID19 in India. The final kit will have two variants and is expected to be rolled out of AMTZ campus by June 1st week of 2020.   ]]> https://biospectrumindia.com/news/97/16418/niv-develops-covid-kavach-elisa-detection-test.html https://biospectrumindia.com/news/97/16418/niv-develops-covid-kavach-elisa-detection-test.html Mon, 11 May 2020 17:00:00 +0530 Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) at Pune has developed and validated the indigenous IgG ELISA test “COVID KAVACH ELISA” for antibody detection for COVID-19. The test was validated at two sites in Mumbai and has been found to have high sensitivity and specificity. In addition, the test will have the advantage of testing 90 samples together in a single run of 2.5 hours. Moreover, ELISA based testing is easily possible even at district level as the ELISA kit has inactivated virus. There are also minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test. The test has an advantage of having much higher sensitivity and specificity as compared to the several rapid test kits which have recently flooded the Indian market. Speaking on the occasion, Dr. Harsh Vardhan said, “The robust indigenous IgG ELISA test for antibody detection developed by ICMR-NIV, Pune will play a critical role in surveillance of proportion of population exposed to SARS-CoV-2 Coronavirus infection.” ICMR has partnered with Zydus Cadila for mass scale production of the ELISA test kits. After development at ICMR-NIV, Pune, technology has been transferred for mass scale production to Zydus Cadila, which is an innovation driven global healthcare company. Zydus has proactively taken up the challenge to expedite the approvals and commercial production of the ELISA test kits so that they can be made available for use at the earliest. The test is named as “COVID KAVACH ELISA”. This is a perfect example of “Make in India” in record time. ]]> https://biospectrumindia.com/news/97/16404/mylab-increases-production-capacity-to-2-lakh-tests-per-day-.html https://biospectrumindia.com/news/97/16404/mylab-increases-production-capacity-to-2-lakh-tests-per-day-.html Mon, 11 May 2020 08:00:00 +0530 Pune-based Mylab Discovery Solutions has completed expansion of its production capacity to manufacture COVID-19 RT-PCR tests. As per the production plan, Mylab is scaling-up manufacturing to 2 lakh tests per day. Adar Poonawalla, CEO, Serum Institute of India said, "It overwhelms me to see our efforts with Mylab in making India self-reliant in combating COVID-19 fructified. As our production capacity increases from 20,000 tests per day to 2 lakh COVID-19 tests per day, we will now be able tomeet India's growing demand for testing completely.” “This is an important milestone for the Make in India initiative as it sets a precedent of health institutions coming together to work towards the interest of public health. It further helps our government reduce its dependency on foreign counterparts with an assurance of quality andreliability." he further added Until now Mylab has already manufactured 6.5 lakh tests and has supplied tests to 140 sites including labs and hospitals in over 20 states of India. With the support of India Post (The Department of Posts), the company has been able todeliver test kits across different parts of the country including Armed Forces Medical College in Pune, District Mineral Foundation, of Odisha, and R & R Army Hospital of Delhi. The company has also received approval from Indian Council of Medical Research (ICMR) for its RNA extraction kit, Maverick, to further streamline the RT-PCR testing process. Hasmukh Rawal, Managing Director, Mylab Discovery Solutions said, “We aim to make India self-reliant with high-quality testing. As we ramp-up our production, our focus on quality is more than ever. Supplied with endogenous internal control for housekeeping gene, our kits can ensure that we can detect samples which were not collected, transported or processed correctly and remove false negatives.” ]]> https://biospectrumindia.com/news/97/16400/roche-diagnostics-india-unveils-elecsys-antisarscov2-assay.html https://biospectrumindia.com/news/97/16400/roche-diagnostics-india-unveils-elecsys-antisarscov2-assay.html Fri, 08 May 2020 13:00:00 +0530 Roche Diagnostics India has announced that it is readying to bring their serology-based SARS-CoV-2 test - Elecsys Anti-SARS-CoV-2 – having received the Import License issued by the Central Drug Standard Control Organization (CDSCO), due to the emergency health situation in public interest. It is significant to note that the test received CE IVD certification iiiand USFDA emergency use authorization (EUA) iva few days ago. Elecsys Anti‑SARS‑CoV‑2 is an immunoassay for the in vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‑CoV‑2) in human serum and plasma. The test is intended as an aid in the determination of the immune reaction to SARS‑CoV‑2. The test runs on all cobas e analysers, and these fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for a single test, with a test throughput of up to 300 tests/hour, depending on the analyzer. Elecsys Anti‑SARS‑CoV‑2 test may also be used together with molecular tests, like Roche’s cobas SARSCoV-2 PCR test, to aid in the diagnosis of suspected COVID-19 patients. ]]> https://biospectrumindia.com/news/97/16394/igib-inks-mou-with-tata-sons-for-covid-19-detection-assay.html https://biospectrumindia.com/news/97/16394/igib-inks-mou-with-tata-sons-for-covid-19-detection-assay.html Fri, 08 May 2020 09:00:00 +0530 New Delhi based CSIR- Institute of Genomics and Integrative Biology (CSIR-IGIB) and Mumbai based TATA Sons have signed a MoU for licensing of knowhow for FNCAS9 Editor Linked Uniform Detection Assay (FELUDA) for rapid diagnosis of COVID-19 The license shall include transfer of the knowledge for scaling up the KNOWHOW in the form of a kit that can be deployed for COVID-19 testing on ground as early as end of May. A completely indigenous scientific invention, FELUDA for COVID-19 has been designed for mitigating the ongoing COVID-19 situation and cater to mass testing. Its main advantages are its affordability, relative ease of use and non-dependency on expensive Q-PCR machines. CSIR IGIB and TATA Sons will now work together to bring it for widespread use at the earliest. Dr Anurag Agrawal, Director-IGIB highlighted that the technology was conceived and developed at CSIR IGIB under sickle cell mission and utilizes an indigenously developed cutting edge CRISPR Cas9 technology to specifically recognize COVID-19 sequence in a sample. A combination of CRISPR biology and paper-strip chemistry leads to a visible signal readout on a paper strip that can be rapidly assessed for establishing the presence of viral infection in a sample. ]]> https://biospectrumindia.com/news/97/16385/adamas-university-biogenick-life-to-develop-covid-19-detection-kit.html https://biospectrumindia.com/news/97/16385/adamas-university-biogenick-life-to-develop-covid-19-detection-kit.html Thu, 07 May 2020 09:00:00 +0530 Kokata based Adamas University has signed a Memorandum of Understanding with Ecura Labs Private Limited (Registered Trademark “Biogenick Life™”). Adamas University and Ecura Labs will be jointly working to develop a cheap and rapid detection kit for the screening of COVID-19 infection. This detection kit will be convenient, rapid, highly sensitive, and extremely suitable for large-scale screening of COVID-19 as compared with the current existing kits in the market. The results can be obtained within 15 minutes using this kit. This kit will also help to reduce the exposure risk of health care workers and facilitate early diagnosis and exclusion of suspicious cases. The MoU was signed by Arup Kumar Sil, Registrar, and Dr. Amalesh Mukhopadhaya, Chairman of Centre for Research and Innovation, from Adamas University and Abhijnan Basu, Director, and Dr. Animikh Ray, Chief Scientific Officer from Ecura Labs Private Ltd. The School of Life Science & Biotechnology at Adamas University will work actively with a team of researchers from Ecura Labs to develop the COVID-19 kit. Dr. Rudra Prasad Saha, Associate Dean, School of Life Science & Biotechnology, and Dr. Anwesha Chatterjee, Assistant Professor, Department of Biotechnology from Adamas University will participate in the joint development of the rapid detection kit. On this development Prof. Samit Ray, Chancellor, Adamas University said, “It is a moment of pride for us. Our professors and whole team is doing a wonderful job. Adamas University is among those top-notch universities which has taken every possible measure to support the current situation. Apart from contributing in the relief funds, Adamas has offered its land for isolation centers where 1000 patients are quarantined. They are also provided necessary essentials like food and water free of cost. All these initiatives are a part of our property #AdamasCares which is completely focused on taking best possible measures to support the nation during this pandemic. We pray that we all quickly overcome the situation and get back to our normal life. Ecura Labs is a private limited company based out of Kolkata, West Bengal (India) which works primarily in the space of AI-based digital health application for disease prognosis assessment & management.   ]]> https://biospectrumindia.com/news/97/16365/abbott-brings-covid-19-antibody-test-to-india.html https://biospectrumindia.com/news/97/16365/abbott-brings-covid-19-antibody-test-to-india.html Tue, 05 May 2020 06:10:00 +0530 Abbott has announced that it has received CE Mark to the IVD Directive (98/79/EC) for its laboratory-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19).  Antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines. Narendra Varde, General Manager and Country Head at Abbott’s diagnostics business in India said, “Abbott has been singularly focused on bringing COVID-19 tests to market as quickly as possible to help address this pandemic. We are proud to be providing our antibody tests in the coming weeks as they will help understand who has had the virus, leading to greater confidence as we get to living life.” Antibody tests to expand testing While molecular testing detects whether someone has the virus, antibody tests determine if someone was infected. Abbott's SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain up to months and possibly years after a person has recovered. The test demonstrated specificity and sensitivity to detect IgG antibodies of greater than 99 percent 14 days or more after symptoms started. Abbott's IgG antibody test will initially be available on its Abbott's IgG antibody test will initially be available on its ARCHITECT® i1000SR and i2000SR laboratory instruments. ARCHITECT is one of the most widely used laboratory systems in the world and it's been used for decades. These instruments are in use in laboratories throughout India and can run up to 100-200 tests per hour. Abbott is significantly scaling up its European manufacturing for antibody testing and will expand testing to its Alinity™ i system. The company will also be expanding its laboratory antibody testing to the detection of the antibody, IgM, in the near future.       ]]> https://biospectrumindia.com/news/97/16329/iit-d-gets-icmr-nod-for-covid-19-assay.html https://biospectrumindia.com/news/97/16329/iit-d-gets-icmr-nod-for-covid-19-assay.html Tue, 28 Apr 2020 08:00:00 +0530 Researchers at the Indian Institute of Technology (IIT) Delhi Kusuma School of Biological Sciences (KSBS) have developed a detection assay for COVID-19 which has now been approved by ICMR. The assay has been validated at ICMR with a sensitivity and specificity of 100%. This makes IITD the first academic institute to have obtained ICMR approval for a real-time PCR-based diagnostic assay. Using comparative sequence analyses, the IIT Delhi team identified unique regions (short stretches of RNA sequences) in the COVID-19 /SARS COV-2 genome. These regions are not present in other human corona viruses providing an opportunity to specifically detect COVID-19. This method uses primers targeting unique regions of COVID-19 that were designed and tested using real time PCR. These primers specifically bind to regions conserved in over 400 fully sequenced COVID-19 genomes. This highly sensitive assay was developed by extensive optimization using synthetic DNA constructs followed by in vitro generated RNA fragments. This is the first probe-free assay for COVID-19 approved by ICMR and it will be useful for specific and affordable high throughput testing. This assay can be easily scaled up as it does not require fluorescent probes. The team is targeting large scale deployment of the kit at affordable prices with suitable industrial partners as soon as possible. ]]> https://biospectrumindia.com/news/97/16324/shetala-agencies-brings-seek-thermal-devices-to-india.html https://biospectrumindia.com/news/97/16324/shetala-agencies-brings-seek-thermal-devices-to-india.html Mon, 27 Apr 2020 16:35:00 +0530 Shetala Agencies, technology product distribution agencies in India, is bringing the entire range of Seek Thermal cameras and devices to India. Seek Thermal, based in Santa Barbara of California, USA provides thermal imaging products, including Seek Scan - a new temperature screening system specifically designed and calibrated for skin temperature measurement during COVID-19 in public and private areas, where large groups of people congregate. Seek Scan is an automated and affordable temperature screening device that automatically detects a face, identifies the most reliable facial features for measurement and displays an alert if someone is warmer than the customizable target temperature. This technology could provide critical help to scan and test people across India and help optimize the initial testing process in areas such as airports etc. Ananth Seshan, Director, Shetala Agencies said, “We are very happy to bring Seek-Scan and other products of Seek Thermal to India. Seek-Scan is a simple, affordable, thermal imaging system designed to automate body temperature screening using skin temperature as a proxy. Seek-Scan can be very useful in this situation as the world is facing the global pandemic COVID-19 as it helps in social distancing to avoid the spread of the virus at the time of temperature screening at various places. It is very easy-to-install and easy-to-use, the system can be up and running in minutes with no special equipment or training.” The other products produced by Seek Thermal are Seek Reveal, Seek Shot and Seek Compact. Seek Reveal is a durable, handheld thermal camera that combines high-resolution thermal imaging, a long-lasting rechargeable battery, and a large color display in one durable device. Seek Shot is the most advanced thermal imaging camera for building/construction professionals. It helps in capturing a photo and analyzing it immediately with on-device measurement tools. Seek Compact is a series of powerful thermal imaging cameras designed for smartphones. It transforms a smartphone or tablet into a professional thermal imaging tool.   ]]> https://biospectrumindia.com/news/97/16319/medall-diagnostics-gets-approval-for-covid-19-test.html https://biospectrumindia.com/news/97/16319/medall-diagnostics-gets-approval-for-covid-19-test.html Mon, 27 Apr 2020 11:45:00 +0530 Medall Diagnostics, a leading integrated diagnostic services provider has announced the receipt of approval from the Indian Council of Medical Research (ICMR) for conducting COVID-19 tests. Speaking on the approval received last evening, Arjun Ananth, CEO, Medall, said “There is an urgent need to bring in more and more private laboratories for testing the samples. Reliable testing to screen for the disease is becoming increasingly apparent. As a quality focused, integrated diagnostic service provider, Medall is uniquely placed to meet the growing demand for reliable and quick testing of Coronavirus samples using the standard, state-of-the-art Real Time Polymerise Chain Reaction (RTPCR) testing methodology. We also look forward to working closely with the Government of Tamilnadu to enhance its testing capacity further”. With a new 15,000 square feet central reference lab at Guindy in Chennai, equipped with state-of-the-art equipment, Medall has the capacity to process close to 1000 samples every day, positioning it as amongst the largest COVID-19 testing providers in the state. ]]> https://biospectrumindia.com/news/97/16327/secureye-reveals-non-contact-biometric-device-for-corporates.html https://biospectrumindia.com/news/97/16327/secureye-reveals-non-contact-biometric-device-for-corporates.html Mon, 27 Apr 2020 00:00:00 +0530 In a bid to promote a secure verification routine, New Delhi based Secureye has launched the Temperature Detection & Face Recognition machine in India. Secureye, a leading brand of security products with a history of 25 glorious years, has always been at the forefront of developing valuable products. With the global pandemic affecting people across the world, the demand for “contactless” systems have risen. To enable corporate houses with contactless attendance of employees along with thermal (fever) detection, Secureye has stepped up to offer this new device.The notable features of Temperature Detection & Face Recognition machine are Temperature Detection, Abnormal Temperature Automatic Alarm, Wearing Mask Identification, Abnormal Temperature Warning, and Binocular Live Detection. The minimum unit from temperature detection is 0.1o C. In case of any anomalies in the body temperature, the device flashes a warning sign and also blows an alarm to alert the concerned authorities. As the fear of COVID-19 is expected to haunt us for months, this feature will help offices stay alert since abnormal body temperature is a significant indication of the virus.Mr. Manish Agarwal, Director, Secureye said “Safety and security become utmost important during the times of crisis. With technology capabilities, it is possible to ensure a secure environment at the workplace, and Secureye’s new Temperature Detection & Face Recognition machine is an ace device for this purpose. We are always looking at the new developments to offer devices that can solve the real problems at the ground level, and hence we have launched Temperature Detection & Face Recognition machine.”The device supports 200W Pixel HD color camera, 100W infrared cameras and can perform body temperature detection from up to 0.5 meters. It has a display screen of 12.7CM electronic capacity touch screen with a screen resolution of 854 x 480. For knowledge transfer or communication, the device relies on TCP/IP, WiFi, USB Pen Drive. The device comes with an in-built rechargeable lithium battery with a USB port. It works on LINUX OS and it has the storage capacity 3000 user IDs, 20,000 face IDs, 1,000,000 user records. The device comes with a dynamic facial recognition feature that takes less than 2 seconds to complete verification. It also supports Door sensors function, U disk Port, Wiegand 26/34 input port, and Wiegand WG26/34 Output. ]]> https://biospectrumindia.com/news/97/16297/mylab-ramps-up-production-of-covid-19-diagnostic-kits.html https://biospectrumindia.com/news/97/16297/mylab-ramps-up-production-of-covid-19-diagnostic-kits.html Fri, 24 Apr 2020 09:00:00 +0530 The Technology Development Board (TDB), a statutory body of the Department of Science and Technology (DST), has approved financial support to MyLab Discovery Solutions, Pune, for ramping up production of COVID-19 diagnostic kits they have developed. The company has submitted an application in response to its invitation for proposals for technologically innovative solutions towards fighting COVID-19. Mylab Discovery Solutions is the first indigenous company to develop real-time PCR based molecular diagnostic kit that screens and detects COVID 19 from samples of people who display flu-like symptoms.  With support from TDB, they will ramp up the production of the kits through automation of the facility from current manual process, thereby increasing its current capacity from 30000 tests per day to one lakh test per day. The company is expected to complete the automation within the next few months. This kit has been approved by ICMR and CDSCO. The kit will be deployed in a very short time, considering the national emergency. TDB invited applications from Indian companies and enterprises to strengthen the nation’s core capacities in surveillance, infection prevention, control, laboratory support, and in particular, the preparedness in terms of isolation and ventilator management of critically ill patients for containing, preventing the spread of COVID-9 on March 20, 2020. TDB’s mandate is to provide financial assistance to private limited companies for the commercialization of Indigenous technologies. MyLab was one of the companies responding to the invitation. ]]> https://biospectrumindia.com/news/97/16301/oncocyte-collaborates-with-core-diagnostics.html https://biospectrumindia.com/news/97/16301/oncocyte-collaborates-with-core-diagnostics.html Thu, 23 Apr 2020 18:25:00 +0530 Oncocyte Corporation, a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum has announced that it has entered a distribution agreement with CORE Diagnostics, expanding the commercial availability of DetermaRx™ to India, the Middle East and Africa. DetermaRx™ is Oncocyte’s treatment stratification test that identifies patients at high risk for lung cancer recurrence, who may benefit from adjuvant chemotherapy post-surgery. Under the terms of the agreement, tissue samples needed for the test will be run in the United States by Oncocyte, while CORE Diagnostics will generate test orders and provide customer service to patients. Ron Andrews, Chief Executive Officer of Oncocyte said, “As we think about expanding beyond the U.S., one of our strategies is to partner with labs focused on delivering high value, proprietary diagnostics into an existing oncology channel to generate demand and brand awareness. CORE Diagnostics does exactly that. We believe CORE’s oncology salesforce of 100 people and customer base of 5000 ordering physicians in 12 different countries will be critical as we work to increase awareness and availability of our tests among physicians and patients globally. We are thrilled to embark on this collaboration with such a respected and growing brand in this important market and are looking forward to tens of thousands more patients having access to our tests, potentially saving lives in the process. As we continue to grow, we intend to extend this distribution model to other geographies including South America and other parts of Asia as well.” Zoya Brar, Chief Executive Officer and Founder of CORE Diagnostics added, “The market for molecular testing in India and the Middle East is quite large. We focus on partnering with labs that offer proprietary diagnostics fulfilling an unmet need at a patient friendly price for our population, and we believe DetermaRx perfectly fits these characteristics. We look forward to making this test and potentially other diagnostic tests from Oncocyte available across these countries in the future.” Padma Sundar, Senior Vice President, Marketing and Market Access at Oncocyte said, “We’re thrilled with the progress made thus far to expand the availability of DetermaRx, both in the U.S. and beyond. I’m incredibly proud of our team’s rapid pivot to virtual operations as the COVID-19 situation began to progress and am confident that the quick expansion in DetermaRx test adoption sites was driven by this foresight. Our online peer-to-peer physician engagement initiatives have reached over 1500 potential participants. Additionally, we’ve seen success with virtual onboarding of sites using sophisticated physician office-friendly software for easy test ordering, processing and delivery of test reports, as well as prompt customer service. We intend to take these same steps to ensure similar expansion outside of the U.S. and are looking forward to continued progress.” DetermaRx was launched in the United States through an Early Access Program (EAP) in late January 2020 with two sites. Since then it has continued to gain traction, rapidly expanding to eighteen sites in just the first three months of launch.  ]]> https://biospectrumindia.com/news/97/16292/aiims-delhi-to-deploy-robots-for-containing-covid-19-spread.html https://biospectrumindia.com/news/97/16292/aiims-delhi-to-deploy-robots-for-containing-covid-19-spread.html Thu, 23 Apr 2020 07:00:00 +0530 Being tried for precautionary measures, these robots will help AIIMS to promote physical distancing between health workers and coronavirus infected patients. As India’s healthcare system grapples with increasing cases of COVID-19, robotics brand Milagrow has announced its efforts with AIIMS, Delhi to help contain the spread of the pandemic amongst doctors and healthcare workers. Under this effort its advanced AI-powered robots – Milagrow iMap 9 and Humanoid ELF will be tested in the advanced COVID-19 ward at AIIMS, Delhi.  Manufactured in India, the Milagrow iMap 9 is a floor disinfecting robot that can navigate and sanitize the floors without any human intervention. It can destroy COVID spores on floor surfaces using sodium hypochlorite solution, as recommended by ICMR. The robot moves around autonomously without falling, avoiding obstruction while planning its own path, guided by LIDAR and advanced SLAM technology. Milagrow’s patented Real Time Terrain Recognition Technology (RT2RT) scans at 3600, 6 times per second to make a floor map in real time with an accuracy of upto 8mm over a 16m distance. This enables the iMap 9 to perform successfully in the first attempt, whereas other robots can take twice or thrice the time. Additionally, the robot can do zoning, virtual blocking of avoidable areas and sequential cleaning of zones based on specific needs.  The Milagrow Humanoid ELF enables doctors to monitor and interact with contagious COVID-19 patients remotely with no person-to-person contact, thereby significantly reducing the transmission risk. Bored patients in isolation wards can also interact with their relatives from time to time through this robot. The Humanoid ELF can navigate around the ward independently and record the activities in high definition video and audio. Offering 8 hours of battery life, it can travel about 2.9 km per hour, is 92 cms tall, has more than sixty sensors, one 3D and one HD camera, and a 10.1" display screen. The advanced humanoid features eyes with Emotion, Open API for further development and customization. Both the Milagrow iMap 9 and Humanoid ELF come with the auto charging feature.  Confirming the development, Randeep Guleria, Director of AIIMS, said, “Milagrow Floor Robot iMap9.0 & Milagrow Humanoid will be tried at AIIMS Hospital New Delhi”.  Sharing his insights, Rajeev Karwal, Founder Chairman of Milagrow, added, “Milagrow Robots is very happy to support AIIMS in its effort to fight the Corona pandemic and will work closely to develop more products based on the feedback of actual conditions. Countries like The United States, China, and Italy have already successfully implemented AI-based robots at health facilities to minimize human intervention in treating COVID-19 patients, and India can replicate the same to provide some relief to its frontline healthcare workers in their battle against coronavirus. As the outbreak continues to rise alarmingly, our state-of-the-art robots will help check the virus spread and protect the doctors, nurses and caregivers from getting infected.”   ]]> https://biospectrumindia.com/news/97/16279/kv-reddy-develops-covid-19-specific-ventilator.html https://biospectrumindia.com/news/97/16279/kv-reddy-develops-covid-19-specific-ventilator.html Wed, 22 Apr 2020 11:00:00 +0530 Konda Vishweshwar Reddy, Engineer, Inventor, Entrepreneur and former Member of Parliament has announced a global breakthrough with the development of ICo-Vent Ventilator. The ICo-Vent is an Indian, "rapidly manufacturable COVID-19 specific ventilator" that will address the shortage of ventilators in the world and will speedily make available, lifesaving ventilators for treating the thousands of critically-ill COVID-19 patients who require mechanical ventilation. Speaking on the successful demonstration and launch of the ICo-Vent, abbreviated for Indian COVID Ventilator, he said, “The successful development of this ventilator is testament to the capabilities of Indian engineering to solve global challenges. An original design that is conceptually new, the components used for manufacture of the ICo-Vent COVID-19 specific ventilator are freely available in most countries including India. The precision of the ventilator does not depend on sophisticated and expensive sensors and regulators. Today, the world needs a million ventilators and with current manufacturers unable to keep up with the supply, we are sure that the ICo-Vent, the first rapidly manufacturable COVID-19 specific ventilator will help to bridge the shortfall. It is the need of the hour and my focus is to ensure this invention benefits humanity.” The unprecedented COVID-19 episode exposed the inadequacies of healthcare systems worldwide. Being a virus that affects the respiratory system resulting in ARDS (Acute Respiratory Distress Syndrome), governments and healthcare systems the world over suddenly found that they needed a lot more ventilators than they had to tackle the COVID situation, but not every ventilator works on COVID-19 positive patients. This led to a global race to design and build ventilators. However, not all ventilators, Mechanized AMBU bags, CPAP machine, BIPAP machines can work for COVID-19 positive patients in critical care. The UK, Canada and other governments have come out with a set of specifications defining "the minimum clinically accepted criteria for a rapidly manufacturable ventilator to address the COVID-19 situation." The Indian government is also in the process of coming out with a similar set of specifications. The ICo-Vent, meets these specifications. A patent for the technology and function has already been applied for. The ICo-Vent addresses the shortcoming of the conventional ventilators used in ICUs for critically ill patients. Most of the other ventilators especially those based on mechanized ambu bags provide no clinical benefits for use on COVID-19 patients, on the other hand, they can potentially cause ventilator induced lung injury and also put healthcare professionals under great risk as their operation can lead to the release of a huge viral load into the ICU atmosphere. Many healthcare workers in other countries have succumbed to this viral load. The ICo-Vent specially designed for COVID-19 and ARDS patients also allows the Intensive Care specialist or the pulmonologist to order a precise volume of air and oxygen at a precise inspiration pressure and a precise expiration pressure considering the compliance or the elasticity of the lung. Konda Vishweshwar Reddy is an engineer, inventor and innovator, social entrepreneur and a public representative. A former Member of Parliament (2014-19) from the Chevella Constituency of Telangana, he is an alumnus of The Hyderabad Public School, Begumpet and an Electrical Engineer from NJIT, USA. He has served as a former CEO & MD of Wipro HCIT Ltd. & General Electric MSIT (GE). He is currently the Managing Director of Stephan Design & Engineering Ltd. and AVV Turbines Limited.    ]]> https://biospectrumindia.com/news/97/16261/sctimst-develops-rapid-detection-kit-for-covid-19.html https://biospectrumindia.com/news/97/16261/sctimst-develops-rapid-detection-kit-for-covid-19.html Mon, 20 Apr 2020 04:00:00 +0530 Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum, an Institute of National Importance, of the Department of Science and Technology (DST), has developed a diagnostic test kit that can confirm COVID19 in 2 hours at low cost. The confirmatory diagnostic test, which detects the N Gene of SARS-COV2 using reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP), will be one of the world’s first few if not the first of its kinds in the world. The test kit, funded by the DST called Chitra GeneLAMP-N, is highly specific for SARS-CoV-2 N-gene and can detect two regions of the gene, which will ensure that the test does not fail even if one region of the viral gene undergoes mutation during its current spread. The tests performed at NIV Alappuzha (authorized by ICMR) show that Chitra GeneLAMP- N has 100% accuracy and match with test results using RT-PCR. This has been intimated to ICMR, the authority to approve it, for COVID-19 testing in India, following which License needs to be obtained from CDSCO for manufacture. Current PCR kits in India enable detection of E gene for screening and RdRp gene for confirmation. Chitra GeneLAMP-N gene testing will allow confirmation in one test without the need for a screening test and at much lower costs. The detection time is 10 minutes, and the sample to result time (from RNA extraction in swab to RT-LAMP detection time) will be less than 2 hours. A total of 30 samples can be tested in a single batch in a single machine allowing a large number of samples to be tested each day.  ]]> https://biospectrumindia.com/news/97/16250/thsti-functioning-as-diagnostic-facility-for-covid-19.html https://biospectrumindia.com/news/97/16250/thsti-functioning-as-diagnostic-facility-for-covid-19.html Fri, 17 Apr 2020 06:10:00 +0530 The bioassay laboratory of Department of Biotechnology’s Faridabad-based Translational Health Science and Technology Institute (THSTI) will now function as an extension of diagnostic facility of ESIC Medical College and Hospital, Faridabad for COVID-19 testing. It will be the first and only COVID-19 testing facility in the Faridabad region. A Memorandum of Understanding (MoU) signed between the two institutes also provides for the team at the bioassay laboratory to train manpower and build capacity at the ESI hospital for COVID-19 testing. While THSTI is funded by Department of Biotechnology in the Union Ministry of Science and Technology, ESIC Medical College and Hospital, Faridabad is a premier medical institution under the Union Ministry of Labour and Employment. DBT- THSTI’s bioassay laboratory was established under the DBT-funded Translational Research Program of THSTI. It was set up for clinical development of vaccines and biologicals. It is intended to meet the global standards in Good Clinical Laboratory Practice (GCLP) and will be applying for accreditation by National Accreditation Board for testing and calibration Laboratories (NABL) for vaccine development and testing. This MoU was signed following the Indian Council of Medical Research (ICMR) decision to undertake an expansion process wherein it engaged government laboratories, which were not under ICMR, to also initiate testing facilities. This includes laboratories of DBT, Council of Scientific and Industrial Research, Defence Research and Development Organisation, and government funded medical colleges, among others. ]]> https://biospectrumindia.com/news/97/16249/redcliffe-life-sciences-tackles-covid-19-with-bsip.html https://biospectrumindia.com/news/97/16249/redcliffe-life-sciences-tackles-covid-19-with-bsip.html Thu, 16 Apr 2020 18:40:00 +0530 Redcliffe Life Sciences, molecular diagnostics company, has partnered with the Birbal Sahni Institute of Palaeoscience (BSIP), Lucknow in a bid to contribute to the ongoing diagnostics and discoveries around COVID-19. While BSIP, which is accredited by the Department of Science and Technology (DST) has been appointed as the sample analyzing center (SAC), Redcliffe will provide infectious diagnostic testing services for COVID-19. The partnership is in line with Redcliffe’s efforts towards helping in the research around the recent health pandemic and discussions to offer support with some equipped institutions that have BSL2 facilities. The diagnostic company recently got approval for this unique PPP model from BSIP. Speaking about this, Ashish Dubey, Co-Founder, Redcliffe Life Sciences, said, “We are happy to be associated with the Department of Science & Technology, Government of India affiliated Birbal Sahni Institute of Palaeoscience (BSIP) for a contribution towards the research around the novel coronavirus. With our combined capabilities, we hope to become a game-changer in the efforts towards tackling the pandemic and assist the governmental efforts in this direction. There are not many testing labs in Uttar Pradesh and given the need for testing in a large set of population, we are keeping ourselves ready with the infrastructure.” Dr. Vandana Prasad, Director, BSIP and Dr. Niraj Rai, in-charge of ancient DNA lab at BSIP Lucknow said, “As part of the association, BSIP will provide up and running infrastructure BSL2 and above, as per the ICMR guidelines. The institution will also design the assays and protocols to test the presence and absence of COVID 19 using RT-PCR as per the ICMR guidelines. Redcliffe, on its part, will help conduct a prescribed diagnostic test within a set turn-around time (calculated from the sample receipt) and issue a formal test report using their manpower who are trained at handling infectious samples.” The Redcliffe team along with Dr. Niraj Rai and his team at BSIP are working on a mass-screening assay to diagnose a large population using a mass array technology. Redcliffe will also provide special pricing for tests generated by BSIP or follow the ICMR guidelines when testing for any other such government institutions. The company will provide sample collection kits (wherever necessary) apart from manpower, logistics, and the necessary reagents/kits to BSIP. It will further help in waste management and disposal of the biological material as per ICMR guidelines.   ]]> https://biospectrumindia.com/news/97/16242/icmr-approves-13-antibody-based-rapid-tests.html https://biospectrumindia.com/news/97/16242/icmr-approves-13-antibody-based-rapid-tests.html Thu, 16 Apr 2020 12:00:00 +0530 Till date, 16 antibody based rapid tests for COVID-19 have been validated at the ICMR- National Institute of Virology (NIV) Pune, and the following were found to be satisfactory- 1. SARS-CoV-2 Antibody test (Lateral flow method): Guangzhou Wondfo Biotech, Mylan Laboratories Limited (CE-IVD) 2. COVID-19 IgM IgG Rapid Test: BioMedomics (CE-IVD) 3. COVID-19 IgM/IgG Antibody Rapid Test: ZHUHAI LIVZON DIAGNOSTICS (CEIVD) 4. New Coronavirus (COVID-19) IgG/IgM Rapid Test: Voxtur Bio Ltd, India 5. COVID-19 IgM/IgG Antibody Detection card Test: VANGUARD Diagnostics, India 6. Makesure COVID-19 Rapid test: HLL Lifecare Limited, India 7. YHLO SARS-CoV-2 IgM and IgG detection kit (additional equipment required): CPC Diagnostics 8. ACCUCARE IgM/IgG Lateral Flow Assay kit: LAB-CARE Diagnostics (India Pvt. Ltd) 9. One Step Corona Virus ( COVID-19 ) IgM/IgG Antibody Test: ALPINE BIOMEDICALS 10. Abchek COVID-19 IgM/IgG Antibody Rapid Test: NuLifecare 11. Standard Q Covid -19 IgM/IgG Duo test – One Step Rapid Antibody test: SD Biosensors 12. Immuno Quick Rapid Test for Detection of Novel Coronavirus ( COVID-19 ) IgM/IgG Antibodies: ImmunoScience India Pvt.Ltd 13. COVID 19 IgM/IgG Rapid Test Kit: Medsource Ozone Biomedicals   ]]> https://biospectrumindia.com/news/97/16217/cyient-receives-certification-for-asic-design-and-supply.html https://biospectrumindia.com/news/97/16217/cyient-receives-certification-for-asic-design-and-supply.html Tue, 14 Apr 2020 12:00:00 +0530 Cyient, a global engineering and technology solutions company, today announced that AnSem, a Cyient company, has received the ISO 13485:2016 certification for design and supply of integrated circuits to the MedTech market. ISO 13485:2016 is an international quality management standard essential for the medical device industry to ensure the safety and traceability of medical products. AnSem is Cyient’s center of excellence for custom turnkey mixed-signal ASICs and is managing its complete life cycle—from design requirements to high-volume production until end-of-life.  The recognition reaffirms the company’s long-standing track record in developing advanced ASIC circuit design for class III implants, medical patches, hearing aids, medical imaging, and nurse call localization and alarm systems. From design requirements to high-volume production until end-of-life, Cyient provides custom turnkey mixed-signal ASICs and manages its complete life cycle.  This certification also applies to the supply of custom ASIC components. Cyient provides a one-stop-solution to its MedTech OEM customers with a smooth path from prototype approval to high-volume production and continuous support during the lifetime of the medical product.   As a specialist in analog mixed-signal custom ASIC solutions, Cyient has deep expertise in wireless energy transfer, sensor signal acquisition, wireless communication, high-speed interconnect, and embedded power management. Speaking on the achievement, Suman Narayan, Sr. Vice President and Head of the MedTech & Healthcare and Semiconductor business units, said, “We are excited to receive the ISO 13485 certification. Cyient has 20 years of OEM and electronic box-build experience in medical devices, and this certification expands our product development and digital solutions offering for the development and supply of custom ASIC for our MedTech customers.” Stefan Gogaert, General Manager, AnSem, commented, “The ISO 13485 certification demonstrates our commitment to providing high-quality ASIC design and supply to our medical customers, enabling them to meet regulatory requirements and device certification and CE marking/FDA approval.” ]]> https://biospectrumindia.com/news/97/16191/redcliffe-life-sciences-to-tackle-covid-19-spread-through-genome-sequencing.html https://biospectrumindia.com/news/97/16191/redcliffe-life-sciences-to-tackle-covid-19-spread-through-genome-sequencing.html Fri, 10 Apr 2020 13:25:00 +0530 In a bid to contribute towards the ongoing research and development around COVID-19, Redcliffe Lifesciences has submitted a proposal to the Ministry of Health, Government of India and the Indian Council for Medical Research (ICMR). The diagnostic company who is also into therapeutics drug discovery and infectious disease testing aims to undertake Genome Sequencing of COVID-19 for routine surveillance and outbreak response. The company aims to utilize its revolutionary technology for this purpose and provide a major boost to governmental efforts in tackling the pandemic.  The biggest challenge during any outbreak for scientists is to predict the pattern or evolution and disease spread, especially with RNA viruses such as the COVID19, which have very high genetic variability. This makes it difficult to understand the transmission pattern, number of active strains and their geographical locations, or if a person is affected with multiple strains. Whole-genome sequencing (WGS) is a globally accepted practice and can prove to be a gamechanger in this regard by providing the highest possible resolution information about an organism’s genome. It has the potential to transform infectious disease management and help combat the disease in a better manner.  Speaking about this, Ashish Dubey, Co-Founder, Redcliffe Life Sciences, said, “It is our endeavor and mission to assist in the efforts being made by the Government of India and other authorities in combating this pandemic. By providing our scientific input and using our technology, we believe that we can assist them evaluate most of the available information. Our aim is three-fold: understand the various strains of COVID-19 if any, found in the Indian public; evaluate the spread patterns of these mutations in different geographic areas, and predict the response of drugs on each such viral strain. We are positive about the opportunity offered by whole genome sequencing in taking quick treatment decisions for combating COVID-19.” Redcliffe’s assay approach is helpful in targeting the entire coronavirus genome and can cover more than 99% of the viral genome and its variants. They have a proprietary computational pipeline that can automatically analyze the sequences and identify various viral strains based on patient samples. The enhanced understanding of the genetic makeup of this virus can eventually help in saving lives given the urgency and in forming strategies for public and clinical healthcare. It will also lead to the creation of therapies and vaccines to combat the virus. ]]> https://biospectrumindia.com/news/97/16184/ncl-bel-to-produce-medical-devices-for-tackling-pandemic.html https://biospectrumindia.com/news/97/16184/ncl-bel-to-produce-medical-devices-for-tackling-pandemic.html Fri, 10 Apr 2020 08:00:00 +0530 CSIR’s constituent Lab, CSIR-National Chemical Laboratory (NCL) Pune, has been leading the way in promoting innovation and entrepreneurship through its Venture Centre for the past decade and new innovations from there are helping in fight against the Corona outbreak.  Two of the recent innovations that can help in the mitigation of the Corona outbreak are featured: Digital IR Thermometer: CSIR-NCL’s Venture Centre’s incubatee BMEK headed by Pratik Kulkarni has developed hand held digital IR thermometer which is an important component of measures to mitigate Coronavirus outbreak. Mobile phone or power banks can be used as a power source. The design of IR thermometers is available open source where in the complete know-how with mass manufacturing ready hardware and software design will be available to manufacturers across India for free. This is an effort to enable a large number of manufacturers to manufacture the thermometers and cater to their local demands.  Now it is being scaled up in partnership with BEL (Bharat Electronics Ltd, Pune). About 100 prototype units will be made for pilot distribution and testing at TUV Rheinland India Pvt Ltd Bangalore. Oxygen enrichment unit (OEU): One of the critical needs of COVID-19 patients is the need to meet the oxygen requirements due to their lungs being compromised. Oxygen enrichment unit (OEUs) to increase the oxygen concentration from the ambient air of 21-22% to 38-40% have been developed by CSIR-NCL and Genrich Membranes, a start-up innovation venture founded by Dr. Ulhas Kharul, Head of Polymer Science & Engineering Divsion at NCL. OEU is hollow fiber membrane bundles for separation and filtration of ambient air to produce enriched oxygen for patients in home and hospital settings. The prototype units are ready at Pune and will be sent to TUV Rheinland India Pvt Ltd Bangalore for testing/validation. About 10 OEU machines will be assembled by NCL, BEL in Pune and after the trials, scale up will be done. ]]> https://biospectrumindia.com/news/97/16159/dayananda-sagar-university-designs-face-shields-for-medical-professionals.html https://biospectrumindia.com/news/97/16159/dayananda-sagar-university-designs-face-shields-for-medical-professionals.html Wed, 08 Apr 2020 12:00:00 +0530 With the onset of COVID-19 and its uncontrollable spread, we need quick solutions to all possible hurdles to effectively fight the pandemic. While the demand for masks escalate rapidly, countries across the globe grapple to meet the requirement. Also, ensuring safety and protection of healthcare professionals is a priority.  Management of the Dayananda Sagar University posed this challenge to the academicians in the University to come out with quickly implementable solutions, making use of the available resources. Experts at the AUTODESK Design and Innovation Centre, Innovation Labs at DSU have come up with a Face Shield which is an important part of the Personal Protective Equipment needed by the healthcare professionals. It involves two components (a) Support with quick attach-detach attachment points to rest on the forehead of user and (b) Transparent film which protects the face of the user from viral load. Based on the design, several units have been 3-D printed by the DSU team and released to Doctors for evaluation. After some iterations involving evaluation, design and manufacture, it is proposed to transfer the technology for mass-production to achieve cost affordability by common users. Typical pictures are shown below. The Face shield has been manufactured using FDM (Fused Deposition Modelling), a 3D printing process that uses a filament of a thermoplastic material. It uses Polylactic Acid (PLA) as a filament material and 120 Micron Overhead Projector Film as a shield which is swappable for fitting new film after use. The product is developed by Mr. Vinayaka K, Manager, Autodesk Design and Innovation Centre, DSU; Dr. Suryanarayana, Professor - Aerospace Engineering, DSU and Ajay P, Student - Automobile Engineering, DSCE. The first product was launched on 28th March and utility started on 31st March. “The Face Shield has been primarily developed for the medical professionals who face the greatest risk and are more vulnerable to catching the respiratory infections akin to the coronavirus. The aim is to give them extra coverage and protection. As there are lot of people who are in close proximity with the patients, the requirement of such safeguards is large. We already have multiple orders for the product and are continuously searching out for ways to enable mass production amidst limited access to resources and technology.” says Vinayaka K , Dayananda Sagar University. He added “We are willing to take approval from Indian Council of Medical Research (ICMR), Bangalore.”  ]]> https://biospectrumindia.com/news/97/16160/healthium-medtech-geared-for-un-interrupted-production-of-essential-medical-devices-.html https://biospectrumindia.com/news/97/16160/healthium-medtech-geared-for-un-interrupted-production-of-essential-medical-devices-.html Wed, 08 Apr 2020 12:00:00 +0530 Healthium Medtech, one of the largest medical device companies in India is geared up to ensure un-interrupted production of essential medical devices amidst the nationwide lockdown due to the COVID-19 pandemic. Continued production is essential given that the devices produced by the company including gloves, surgical suture needles, haemostats, meshes and other surgical products are commonly used in Operation Theatres(OTs) during emergency surgeries as well as child birth, both of which continue despite the current pandemic. Healthium has stepped up safety measures to protect its employees and workers at the facilities across the country by ensuring stringent hygiene, social distancing and working within a sterile environment. Healthium Medtech has also procured the necessary permissions and is acting in close adherence to government norms to ensure the manufacturing plants continue steady production to supply medical consumables and equipment including gloves to the healthcare industry. It has also opened its warehouses in order to transport stocks to the dealers and hospitals to keep the supply chain moving. Healthium Medtech in its continuous efforts to support communities, has distributed masks, sanitizers, gloves and also introduced awareness & education programmes to communities around their manufacturing facilities – Kunigal & Peenya to fight against COVID-19 The Healthium Group has also contributed INR 82lakhs to the Prime Minister’s National relief Fund and surgical products worth INR 20Lakhs have been accepted by Chhattisgarh Institute of Medical Science (CIMS), Bilaspur for the needy patients. These will be delivered soon. “We are committed to support our community and stand with our people in the battle against the pandemic. Safety & security of our people is the top priority during the current situation and we are ensuring adequate measures are being taken to ensure the same. The medical community has risen to support the fight against the pandemic and it is our endeavour to supply essential medical devices so that patient care remains unhindered. Our employees and the worker teams have come together to support this larger cause and I am immensely thankful for their support.” said Anish Bafna, Chief Executive Officer, Healthium Group. ]]> https://biospectrumindia.com/news/97/16155/icmr-approves-covid-19-testing-kits-by-molbio-diagnostics-.html https://biospectrumindia.com/news/97/16155/icmr-approves-covid-19-testing-kits-by-molbio-diagnostics-.html Wed, 08 Apr 2020 11:10:00 +0530 Molbio Diagnostics Pvt. Ltd, supported by India Health Fund, through the Centre for Health Research and Innovations (CHRI), has recently obtained approval from Indian Council of Medical Research (ICMR) for its testing kit -- the Truenat Beta CoV test to be used by patients to test for COVID-19. This kit will be used as a screening test for COVID-19, with test results available within an hour. This will enable same day testing, reporting, and initiation of patient isolation if required – thereby reducing the risk of infection spreading while waiting for results. The cost of each test is under INR 1350. Truenat Beta CoV test is the second Made-In-India diagnostic solution that has been approved for use by ICMR in a short span of time. Support from India Health Fund, since 2019, has enabled Molbio Diagnostics Pvt. Ltd and CHRI to demonstrate the effectiveness of Truelab in diagnosing TB and Rifampicin resistance at the district hospitals and community health centres in Uttar Pradesh, where it has been initially deployed. This platform has the potential to perform molecular diagnostics for infectious diseases at the point-of-care through its Truelab Real Time Quantitative micro PCR System.  The ability to screen for COVID-19 is an additional feature added to the Truelab Real Time Quantitative micro PCR System developed by Molbio Diagnostics. Dr. Chandrashekhar Nair, Chief Technical Officer at Molbio Diagnostics Pvt. Ltd, pointed out, “The need of the hour is to augment access to molecular diagnostics in a fast-track mode with required financial support which will help in better preparedness to tackle in controlling pandemics like COVID-19 and outbreaks in future”. Madhav Joshi, Chief Executive Officer, India Health Fund said, “India Health Fund’s Quest for Innovations 2020 is an opportunity for all entrepreneurs, innovators, & scientists to come forward with their ideas and solutions, and partner with India Health Fund to accelerate the development & deployment of their tools and technologies.” India Health Fund is an organisation seeded by Tata Trusts to identify and support breakthrough innovations which will help accelerate the elimination of infectious diseases in India. It has so far focused on supporting innovations which leverage technology, artificial intelligence, molecular diagnostics and product design to improve the diagnosis, treatment & prevention of TB and malaria – like Truelab from Molbio Diagnostics.     ]]> https://biospectrumindia.com/news/97/16124/neuberg-offers-covid-19-self-assessment-test.html https://biospectrumindia.com/news/97/16124/neuberg-offers-covid-19-self-assessment-test.html Fri, 03 Apr 2020 15:50:00 +0530 Neuberg Diagnostics Private Limited, a StartUp in the PathLab chain segment has announced a COVID-19 self-assessment test on its website, wherein one just needs to answer a few questions to know whether she / he needs to get in touch with a doctor.  This self-health assessment scan has been developed as per the guidelines laid down by WHO (World Health Organisation) & MOHFW (Ministry of Health & Family Welfare), Government of India, to help individuals assess their risk of contracting COVID-19. Speaking on the occasion, Aishwarya Vasudevan, Chief Operating Officer, Neuberg Diagnostics Private Limited said, “Given the present scenario, where the entire world is combating a fast-spreading deadly virus, a tool like this will help people at large to understand their risk and will help reduce the panic amongst them considering a fever or cough may be just a seasonal flu or fever.”   “We urge people to take the COVID-19 self-assessment test on our website, this will help remove any doubts and to ensure safety for themselves and their near & dear ones. At the same time, it must be noted that this tool is not a replacement of an expert medical advice and it is always advisable to consult a doctor in case of any symptoms,” she added. Basis the self-assessment, one may decide if she / he needs to get in touch with a doctor.   ]]> https://biospectrumindia.com/news/97/16105/medgenome-raises-funding-worth-55m-.html https://biospectrumindia.com/news/97/16105/medgenome-raises-funding-worth-55m-.html Fri, 03 Apr 2020 08:05:00 +0530 MedGenome, the leading genetic diagnostics, research and data company focused on expanding access for populations in South Asia and other emerging markets has announced an investment of USD 55m led by LeapFrog Investments, a leading specialist investor in emerging markets. Existing investors Sofina and Sequoia also participated in the round. Sam Santhosh, the CEO and Founder of MedGenome said, “Genomics and personalized medicine are the future of healthcare, but emerging markets remain significantly under-penetrated. As the largest player in India in applied genomics, we are well-positioned to fill this gap”. The subcontinent contributes around 20% of the world's population, while the DNA sequences of its people make up only around 0.2% of global genetic databases. MedGenome has already built the largest database of South Asian genetic variants through its leadership in genetic diagnostics in India, research partnerships and work as a co-founding member with GenomeAsia 100K. The company has completed over 200,000 genomic tests to date and obtains samples from more than 550 hospitals and 6,000 clinicians across India. This investment will expand the clinical genomic testing market by expanding access in Tier-II and Tier-III towns and cities across India and accelerate the company’s drug discovery programs. Sam added, “Genetics is having a transformational impact on families through early disease risk detection, inherited disease prevention, health care personalization, and new therapy development. MedGenome strives to deliver these benefits to India and Emerging Markets, where the burden of many inherited and complex diseases is even higher than in western markets.  We are excited about partnering with the LeapFrog team, who share our focus on profit with purpose, and look forward to leveraging their network and expertise to accelerate achievement of our goals." The MedGenome transaction was led by Dr. Felix Olale, Global Co-Lead for healthcare investments at LeapFrog. Dr. Olale said, “We are very excited to partner with MedGenome to increase access to affordable and high-quality genetic testing for emerging consumers in Asia and Africa. Genomic sequencing will anchor the future of medicine and we must include other underrepresented genomes not only because it drives access, but also because it improves the accuracy for everyone. As the leading player in its field, we believe that our investment will enable MedGenome to rapidly consolidate its position in Asia and become a significant player in the global market for drug discovery and precision medicine. Our investment will also drive the development of new drug discovery platforms that will have an enormous impact on cancer and cardiovascular disease”. The investment in MedGenome will seek to capitalise on the favourable dynamics in both the domestic and international markets for genetic diagnostics. The Indian genetic diagnostics market is expected to expand at 42% CAGR over the next five years. Globally, the market is expected to grow from USD 13bn in 2019 to USD 28.5bn by 2026 driven by improving penetration, affordability and increasing consumer awareness.     ]]> https://biospectrumindia.com/news/97/16109/sai-life-sciences-joins-psci.html https://biospectrumindia.com/news/97/16109/sai-life-sciences-joins-psci.html Thu, 02 Apr 2020 15:10:00 +0530 Hyderabad based Sai Life Sciences, Contract Development & Manufacturing Organizations (CDMOs) has announced its induction into the Pharmaceutical Supply Chain Initiative (PSCI) membership as an 'Associate Member'. Welcoming Sai Life Sciences into its fold, a PSCI spokesperson said, "PSCI and its members are delighted to welcome Sai Life Sciences into membership, PSCI's first member with its main headquarters in India. We are pleased at their enthusiasm in embedding PSCI's Principles for Responsible Supply Chain Management into their practices, and see their addition to our membership as another heartening sign that responsible practices are gaining influence in a country that's important to many of our members' supply chains." The PSCI is a non-profit business membership organization with a vision to establish and promote responsible practices that continuously improve pharmaceutical supply chains. All PSCI members are expected to support and incorporate the organization's core principles that encompass five areas of responsible business practices namely, ethics, labor, health and safety, environment, and management systems, into their supply agreements. Krishna Kanumuri, CEO & Managing Director said, "We at Sai Life Sciences are truly honoured to be inducted into the PSCI membership and join its esteemed league of companies. This step is a strong reaffirmation of our commitment to implement and champion responsible supply chain practices." Sai Life Sciences has adopted Sustainability as an integral part of its business and decision-making framework, shifting from a 'compliance-oriented' approach to a more proactive one. It has undertaken several initiatives including setting up an online learning management system, adopting green chemistry principles in process development, building all new facilities as 'Green Buildings', sourcing renewable energy, improving employee health & safety through industrial hygiene programs and conducting community development programs on education and health care. The company's Sustainable Development Goals (SDGs) focus on minimizing its environmental footprint, strengthening diversity & inclusion, giving back to society and improving its supply chain.   ]]> https://biospectrumindia.com/news/97/16099/mylab-collaborates-with-adar-poonawalla-abhijit-pawar-.html https://biospectrumindia.com/news/97/16099/mylab-collaborates-with-adar-poonawalla-abhijit-pawar-.html Thu, 02 Apr 2020 10:50:00 +0530 In order to scale up the operations and escalate faster delivery of testing kits for the novel coronavirus (Covid-19), Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd has partnered with Serum India’s CEO Adar Poonawalla and Abhijit Pawar, Chairman of APG. Funds invested will be used for scaling production of COVID-19 testing kits and expansion of molecular diagnostic solutions. Abhijit Pawar, Chairman AP Globale, MD - Sakal Media Group said, “We are honoured to stand by our Prime Minister and our government, while supporting them during these trying times. This partnership will ensure we do our bit to help in this time of crisis.” Talking about the partnership, Adar Poonawalla, CEO, Serum Institute India’s said, “In the next few weeks we will be ramping up the production of the Covid-19 testing kits taking from 1.5 lakh tests/week to 20 lakh tests/week. The shortage of testing kits will come to an end in a month or two." Hasmukh Rawal, MD, Mylab Discovery Solutions said, “This partnership can Impact Billions of people across the world, especially India.” Sujit Jain, Director, Mylab Discovery solutions Pvt ltd, MD Netsurf said, “This will help Mylabs create a world class organization, which will help India become a leader in molecular diagnostics." “Global innovation is the need of the hour to curb this pandemic that has affected millions across the world. The need for the maintenance and manufacturing of medical and healthcare equipment at the pace required to keep the numbers at bay has never been more important. Mylabs and their team have shown exceptionally innovative capabilities when they were able to develop a time-saving testing kit within 6-weeks of its outbreak. Keeping in mind their resilient approach and quick response, I am certain that the company has a variety of similar innovation-driven projects which will help bring drastic improvements in the healthcare sector. The investment towards Mylab will enable them to build their infrastructure and expand their capabilities further",  added Adar Poonawalla Mylab is the first Indian company to get commercial approval for its testing kits named as Mylab PathoDetect COVID-19 Qualitative PCR kit. The testing kit is approved by Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and ICMR evaluation.   ]]> https://biospectrumindia.com/news/97/16076/max-healthcare-innovates-to-multiply-the-capacity-of-ventilators.html https://biospectrumindia.com/news/97/16076/max-healthcare-innovates-to-multiply-the-capacity-of-ventilators.html Tue, 31 Mar 2020 12:45:00 +0530 With health experts warning that several countries do not have enough ventilators for a worst-case scenario, doctors and bio-medical engineers have been trying to figure out how to innovate and modify their medical equipment to serve a large number of patients with limited resources. A team of Bio-Medical Engineers from Max Healthcare has come up with an innovative solution to cope with the likely high demand for ventilators during the expected surge in COVID-19 patients. This innovation could increase the capacity of existing ventilators four-fold, thus helping serve a large number of patients.  Speaking on this innovation, Yudhvir Singh, Head- Bio Medical Engineering, Max Healthcare, said, “in 2012, I had read about the possibility of using a single ventilator for supporting 4 patients. During this emerging medical crisis, I received a message from the chairman of our organization, asking employees to come up with innovative solutions for treatment and capacity management. Which led me to think if we can modify the ventilators in the hospital to support more than one patient, it would possibly make an immense contribution in the battle against the pandemic. My team and I then designed a simple but ingenious device, which can be safely attached to the ventilators, splitting the airflow into four distinct streams for 4 patients. We even produced this device in-house using the 3D printing facilities at Max Healthcare”. Since, the country is under a lockdown, it was not possible to get the device fabricated anywhere. But, as the saying, necessity is the mother of innovation, Mr Yudhvir’s team decided to use 3D printing available at Max Hospital Saket to fabricate the device. They used ABS- Acrylonitrile Butadiene Styrene, a lightweight plastic, which is already approved for use in medical devices. To ensure that the patients on the ventilator are protected from infecting each other, Mr Singh and his team installed the usual HME filters as well as bacterial and viral filters, which were available in the hospital. The critical care experts at Max Healthcare extensively tested the device and determined that it worked very well on all functional and patient safety parameters. Speaking on this further, Abhay Soi, Chairman, Max Healthcare, said, “In times of a pandemic when critical resources are scarce, this device can play an invaluable role in saving lives. I am grateful to Yudhvir and his entire team to have come up with this innovation in a matter of days. Currently, we have 254 adult ventilators pan Max Hospitals and now we can serve more patients in case of a dire emergency”. The device is to be used only in case of dire shortage of ventilators.   ]]> https://biospectrumindia.com/news/97/16068/practo-partners-with-thyrocare-for-conducting-covid-19-tests.html https://biospectrumindia.com/news/97/16068/practo-partners-with-thyrocare-for-conducting-covid-19-tests.html Tue, 31 Mar 2020 09:00:00 +0530 Practo, India’s leading digital healthcare platform, has announced that Covid-19 testing is now available for booking on its platform. The company has partnered with Thyrocare to conduct Covid-19 detection tests, which has been authorised by the Government of India and The Indian Council of Medical Research (ICMR). Starting today, the test is available for Mumbai residents, and will soon be expanded to the rest of the country.  A valid doctor’s prescription, duly filled Test Requisition Form signed by the physician, and a photo ID card has to be presented at the time of testing. The test will be available at Rs 4500/- and can be booked at https://www.practo.com/covid-test and https://covid.thyrocare.com/. Certified phlebotomists from I2H will collect the samples from the patients’ homes directly. They will be taking all necessary precautions mentioned in the ICMR guidelines while taking the swabs. The Swab that is taken during the test will be collected in a viral transport medium (VTM) and will be transported in a cold chain to the Thyrocare laboratory which has been selected for COVID-19 testing. The report will be made available to the patients on the Practo website within 24-48 hours of the sample collection.  Dr Alexander Kuruvilla, Chief Health Strategy Officer, Practo, said, “Widespread testing is critical to track the scale and prevent the transmission of Covid-19. To ensure that anyone who experiences the symptoms of the infection can get tested, the government is constantly working on expanding the list of labs and centers. We’ve partnered with Thyrocare to ensure that access to these tests is not an issue. We will continue to work closely with the authorities to identify more such areas where Practo can solve for accessibility – be it for doctor consultations, testing or medicine delivery. We stand firmly committed to our vision of making quality healthcare accessible to all Indians, esp. in difficult times such as these.” Dr. A. Velumani, Chairman and Managing Director of Thyrocare Technologies Ltd said, “Thyrocare wishes to keep it affordable, reach to the bottom of the pyramid and produce significant impact in the nation’s fight against COVID.” ]]> https://biospectrumindia.com/news/97/16084/medtronic-contributes-to-increase-global-ventilator-production.html https://biospectrumindia.com/news/97/16084/medtronic-contributes-to-increase-global-ventilator-production.html Tue, 31 Mar 2020 00:30:00 +0530 Medtronic, the global leader in medical technology, today announced it is publicly sharing the design specifications for the Puritan Bennett™ 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help doctors and patients dealing with COVID-19. This decision is consistent with the recent FDA Guidance and in accordance with the public health and medical response of governmental agencies globally.  Introduced in 2010, the PB 560 is sold in 35 countries around the world. This ventilator’s ability to be used in a range of care settings, as well as its technology and design, make it a solid ventilation solution for manufacturers, inventors, start-ups, and academic institutions seeking to quickly ramp up ventilator design and production. PB 560 product and service manuals, design requirement documents, manufacturing documents, and schematics are now available at Medtronic.com/openventilator. The PB 560 design specifications are available today, software code and other information will follow shortly. The PB 560 ventilator is a compact, lightweight, and portable ventilator that provides airway support for both adults and children. It can be used in clinical settings and at home and provides mobile respiratory support. “Medtronic recognizes the acute need for ventilators as life-saving devices in the management of COVID-19 infections. We know this global crisis needs a global response. Over the past few weeks, we have ramped up production of our Puritan Bennett™ 980 ventilators. But we also know we can do more, and we are,” said Bob White, executive vice president and president of the Minimally Invasive Therapies Group at Medtronic. “By openly sharing the PB 560 design information, we hope to increase global production of ventilator solutions for the fight against COVID-19.” Ventilators play a critical role in the management of patients with severe respiratory illness, such as COVID-19, who require assistance because they cannot breathe effectively. By placing a patient on a ventilator, the patient’s lungs are permitted to rest and recover while the ventilator performs the functions of supplying oxygen and simulating the actions of breathing. Without ventilation support, some patients with severe respiratory disease might not survive.   ]]> https://biospectrumindia.com/news/97/16064/iit-hyderabad-calls-for-adopting-alternatives-to-ventilators-.html https://biospectrumindia.com/news/97/16064/iit-hyderabad-calls-for-adopting-alternatives-to-ventilators-.html Mon, 30 Mar 2020 16:10:00 +0530 Indian Institute of Technology Hyderabad Director Prof. B.S. Murty has called upon on the Government of India to consider adopting ‘bag valve mask’ as an alternative to meet any surge in demand for ventilators, both in India and other countries, to treat COVID-19 patients While the conventional ventilators are expensive, hard to produce, and not portable, Prof. B.S. Murty, Director, IIT Hyderabad and Prof. V. Eswaran, Department of Mechanical and Aerospace Engineering, IIT Hyderabad, highlight that ‘bag valve masks’ are small devices, which are used to deliver breathing support in emergency situations that are inexpensive, easy to produce, and portable - which therefore have every quality that is required in this crisis. They are most common of these devices is the bag valve mask, often called by the propriety name of ‘Ambu Bag,’ that is used for resuscitation in emergency situations. The COVID-19 virus has varied effect on the people it infects. Some barely show symptoms, while they still pass on the virus to others who may be more seriously affected. Of the 15 per cent of COVID-19 affected patients who may need hospitalization, around one-third, (5 per cent) would likely develop respiratory difficulties for which ventilators for assisted breathing will become necessary. The Professors note that while ‘bag valve mask’ are currently hand-powered and therefore not suitable for continuous use as a ventilator, it would be easy to design a similar device powered by an electrical source, which could be a car battery, apart from the conventional power supply. It could be made portable, and therefore adopted in villages and other areas without a power supply and be inexpensive enough to manufacture in bulk. Elaborating on the advantages of this system, Prof. B.S. Murty & Prof. V. Eswaran, Department said, “Our estimate of the cost is that it can be manufactured for less than Rs 5000, or one-hundredth the cost of a conventional machine. The cost of manufacturing 6 million of these devices will be probably less than that of the inadequate number of 60,000 conventional machines mentioned above. The cost is so low that it can be considered a single-use device that will be given over to single patient, and never used again. It needs to be manufactured, however, on an industrial scale, in millions, within a short time of a few months. There have been several designs proposed within India itself, with IIT Hyderabad having at least one proposed design.” The Professors also added that this idea was not new. In the past few weeks, many countries have come up with this idea of manufacture of low-cost ventilators and have even started competitions where the winning design would be declared open-source, which are not patented, and can be given free for anyone to adopt. Several designs are already available for 3-D printing, and so can be manufactured on a small scale on a 3-D printer. However, Prof. B.S. Murty and Prof. V. Eswaran also cautioned that while this was reassuring, there were some caveats involved: These designs are untested, and uncertified Even if inexpensive, the designed devices should be capable of continuous and faultless 24x7 operation for at least one month – which requires very high performance both of the design and the manufactured components While 3-D printing could be part of the manufacturing solution, conventional manufacturing may be much more effective for making the millions of devices in the most rapid and cost-effective way Further, Prof. B.S. Murty and Prof. V. Eswaran said, “We are proposing that the Government of India (through the Department of Science and Technology/Defence Research and Development Organisation, or some other nodal organization) constitute a highly empowered taskforce, which will carry out the tasks needed to start the production of these low-cost ventilators, within a maximum time-frame of two months. The production rate thereafter would need to be of several lakh units per week, so the preparation has to be done at a war-footing, under the direct scrutiny of the highest levels of Government.” A Ventilator is a device designed to force breathable air into the lungs of patients who are unable to breathe for themselves. Modern ventilators are very expensive and sophisticated devices, which are generally found only in the ICUs (intensive care units) of large hospitals. The most sophisticated computer-controlled ventilators cost around Rs. 40 lakh while more modest foreign-made ones cost around Rs. 15 lakh with Indian-made ventilators costing around Rs. 6 lakh. It is estimated that there are around 40,000 ventilators in India at present, mostly in the private hospitals. The Indian industry has a maximum manufacturing capacity of approximately 6,000 units per month, but even the Indian-made devices use a lot of foreign-made parts whose availability would now be uncertain, when every country would be maximizing their own ventilator production. The Professors said that assuming a low 6 per cent infection rate, in case COVID-19 advancement in India continues, in the Indian population of 1.3 Billion, that would mean that around 80 million people would get affected. Of these 80 million, at least 5 per cent (4 million patients) would require ventilators. Each of these 4 million patients would need the ventilators for around 21 days, thereby blocking that machine for at least that amount of time. Further, the machines are not portable and are found only in high-end hospitals in large cities, so patients from villages would need to be transported to these cities, which would be a logistics problem of unimaginable complexity. It is quite clear that even a mild 6 per cent Stage-3 would overwhelm the country’s capacity to a devastating degree. Even if the Indian Industry was at peak production, it could manufacture only another 60,000 machines in the next 10 months, at a cost of Rs. 3,600 crore. Prof. B.S. Murty and Prof. V. Eswaran conclude, “Therefore, the total number of ventilators would barely be 1 lakh devices - at a time when millions of machines may be needed. We cannot depend of the conventional ventilators for a solution to this crisis.” ]]> https://biospectrumindia.com/news/97/16054/global-3d-labs-develops-novel-medical-aids-for-covid-19-battle.html https://biospectrumindia.com/news/97/16054/global-3d-labs-develops-novel-medical-aids-for-covid-19-battle.html Mon, 30 Mar 2020 09:00:00 +0530 Bengaluru based company Global 3D Labs is putting its technology to best use in this fight against COVID-19. With only 40,000 ventilators at the disposal for a population of 1.3 billion people, there will definitely be a shortage of these machines if the impact of coronavirus blows out of proportion. Global 3D Labs has come out with a 3D printed 4-way ventilator splitter that can support 4 patients on a single ventilator. Although this model is being tried and tested to check if a single machine can support a requirement for 4, these splitters can be one of the viable options to look forward to, if and when the need arises. Alongside, the company has also developed 3D printed N-95 masks to reduce the dependency on surgical masks. These masks are capable of filtering out 95% of small particles from the air, a final resort to completely eradicate the need for the use-and-throw face masks. The company is also providing face shields for people working on close quarters with the infected patients. A total of 1200 shields have been printed and delivered to the ones in need. The printing is still going on at the maximum production capacity. ]]> https://biospectrumindia.com/news/97/16052/abbotts-new-covid-19-test-brings-fastest-results.html https://biospectrumindia.com/news/97/16052/abbotts-new-covid-19-test-brings-fastest-results.html Mon, 30 Mar 2020 08:00:00 +0530 Abbott has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments. Abbott will be making ID NOW COVID-19 tests available to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have the greatest impact.  The arrival of the Abbott ID NOW COVID-19 test comes a week after the company launched its Abbott m2000™ RealTime SARS-CoV-2 EUA test, which runs on the m2000™ RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about 5 million tests per month. ]]> https://biospectrumindia.com/news/97/16049/covid-19-testing-starts-at-core-diagnostics-gurugram-lab.html https://biospectrumindia.com/news/97/16049/covid-19-testing-starts-at-core-diagnostics-gurugram-lab.html Fri, 27 Mar 2020 17:00:00 +0530 CORE Diagnostics, NABL-accredited Gurugram-based high end clinical laboratory, has received approval from Indian Council of Medical Research (ICMR) to start testing COVID-19 samples. As COVID-19 outbreak grows across the globe as well as India, the urgent need for widespread testing has also intensified. To ensure zero contamination of the samples, CORE Diagnostics has setup a separate facility within its high-end Gurugram lab to perform the confirmatory polymerase chain reaction based (PCR) COVID-19 test with all strains that are approved by the Government of India (GoI). There will be dedicated technicians and pathologists for COVID-19 testing with a turnaround-time of same day for the results. Apart from this, separate staff will be assigned duties of accepting, cleaning and sanitizing the samples, submission in lab, extraction, report preparation etc. CORE Diagnostics has capabilities to collect samples in accordance with the government protocols. Elaborating on the current situation and the COVID-19 lab, Zoya Brar, CEO and Founder said, “Private testing will definitely prove to be crucial to fight the deadly epidemic by widening the testing capabilities of the nation. CORE Diagnostics follows strict processes and will ensure government protocols are followed in handling samples and testing. We will be using ICMR-approved testing kits to perform the confirmatory PCR-based test and generate the reports same day. We are also in touch with different state governments to setup labs in existing government hospitals, if required.  Beyond this, we are in daily touch with the Stanford University School of Medicine COVID Response Team to stay abreast on daily developments.” ]]> https://biospectrumindia.com/news/97/16041/thyrocare-receives-icmr-approval-for-covid-19-test.html https://biospectrumindia.com/news/97/16041/thyrocare-receives-icmr-approval-for-covid-19-test.html Fri, 27 Mar 2020 11:45:00 +0530 Focusing on preventive health care, Thyrocare becomes the first Indian diagnostic private laboratory to provide COVID testing in Mumbai. In the initial phase, it has started the test in Mumbai. Once Lock Down is lifted, they will make their services available for metros and other cities too.  The company will also be exploring the B2B model by partnering with local hospitals in Mumbai, Navi Mumbai, Thane, Pune and Nashik. Dr. A. Velumani, Chairman and Managing Director of Thyrocare Technologies Ltd said, “Thyrocare wishes to keep it affordable, reach to the bottom of the pyramid and produce significant impact in the nation’s fight against COVID. Partnering with local hospitals is the best way to disseminate this solution countrywide” Some of the key points to notice: COVID testing as now available only in Mumbai, Navi Mumbai and Thane. From 1 April 2020 it would be in Pune and Nashik. Once Lock Down is lifted it would be available in all air connected cities   Sample is Throat or Nasal Swab and not Blood. It is priced as of now at Rs.4500 and it would go down after Lockdown Swab collection needs training and care and personnel are trained for home service It takes 6 hours to report once the sample reaches the laboratory.   ]]> https://biospectrumindia.com/news/97/16043/suse-extends-help-to-medical-device-manufacturers.html https://biospectrumindia.com/news/97/16043/suse-extends-help-to-medical-device-manufacturers.html Fri, 27 Mar 2020 11:10:00 +0530 SUSE®, the world’s largest independent open source software company, has made a commitment to help all organizations that are producing medical devices to fight COVID-19. To that end, SUSE is offering free services such as support and maintenance for its operating system and container technologies to be embedded in and run those medical devices. These SUSE solutions are available immediately to help speed time to market for device manufacturers. Within India, SUSE has operations in Bengaluru, Mumbai and New Delhi. “The current global pandemic requires more from us than simply trying to survive as companies and individuals,” said SUSE CEO Melissa Di Donato. “We are determined to help others as much as we can, doing what we do best. We have cutting-edge open source technology and know-how that can help others in the fight to save lives, and we will share it immediately and without charge. Our customers, partners and communities know of and share our commitment to making a difference – and that extends to our neighbors and fellow human beings around the world.” SUSE Linux Enterprise is an operating system that can be built into, and help run, various kinds of devices, hardware and appliances. SUSE Embedded Linux features an optimized system footprint for specific products, including medical devices. Container technologies from SUSE include SUSE CaaS Platform, which allows companies to use Kubernetes to more easily deploy and manage container-based applications and services, and SUSE Cloud Application Platform, which brings an advanced cloud native developer experience to Kubernetes so companies can get applications to the cloud and devices to market faster. These technologies bring security and reliability to any device they run on or manage. SUSE customers in the pharmaceutical and research space, along with national laboratories all over the world, are already using supercomputers running SUSE Linux Enterprise to find solutions to issues posed by COVID-19, including prevention, treatment and cures.   ]]> https://biospectrumindia.com/news/97/16032/mylab-ships-first-test-kits-batch-to-govt-private-labs.html https://biospectrumindia.com/news/97/16032/mylab-ships-first-test-kits-batch-to-govt-private-labs.html Thu, 26 Mar 2020 12:00:00 +0530 Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd, developed first Made in India Covid-19 testing kit, has announced that it is ready with the first batch of test kits and will start supplying to the government and private labs. In the first batch, Mylab Discovery Solutions will supply testing kits to conduct 15,000 tests. The kit is the first one to receive commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is developed in a record time of six weeks. Given the low testing rate in the country, India’s very own testing kit will help in fighting back the global pandemic Covid-19. Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to 7+ hours taken by current protocols. “At present, Mylab can produce kits to test for 20,000 samples per day. However, in case of an adverse situation, the company can ramp-up its capacity to ship kits to conduct 50,000 tests per day.”, said, Rahul Patil, Executive Director and Operations Head, Mylab Discovery Solutions. Mylab test kits cost nearly one-third to one-fourth of the cost of the price cap provided by ICMR. But private and government labs approved by ICMR can conduct the tests for Covid-19. As of 25th March, ICMR has approved more than 100 government labs and 29 private labs across the country for testing. “We are continuously working with all the testing labs to predict the demand and schedule the supplies of the testing kits.We are letting them know of supply schedules ahead of time”, said Sujit Jain, Advisor and Mentor on Corporate Strategy, Mylab Discovery Solutions. The Mylab manufacturing facility, approved by FDA/CDSCO is compliant with MDR 2017 regulation for Manufacturing Medical Device of Class A,B,C and D and ISO 13485: 2016 certification   ]]> https://biospectrumindia.com/news/97/16027/iqvia-contributes-towards-covid-19-vaccine-development.html https://biospectrumindia.com/news/97/16027/iqvia-contributes-towards-covid-19-vaccine-development.html Thu, 26 Mar 2020 07:10:00 +0530 Q2 Solutions, a leading clinical trial laboratory services organization resulting from an IQVIA and Quest Diagnostics joint venture, has announced its collaboration with the University of Texas Medical Branch (UTMB) to develop a novel assay for COVID-19 (SARS-CoV-2) tests, an essential tool for rapid development of a Coronavirus vaccine. Once a viable assay is developed, Q2 Solutions labs will produce it for use in clinical trials to determine the effectiveness of a COVID-19 vaccine. An assay is an analysis done to determine the biological or pharmacological potency of a drug. Compared with the conventional plaque-based neutralizing assay, UTMB’s novel reporter COVID-19-based test may provide several potential advantages, including increased sensitivity and dramatic increase in assay throughput because the assay time is shifted from multiple days to a single day. “We have successfully produced a reporter virus system engineered with either luciferase or fluorescent tags to enable quantitative determination of vaccine effectiveness,” said Pei-Yong Shi, professor of Human Genetics at UTMB. “This test will enable Q2 Solutions to test sera from individuals participating in vaccine clinical trials to see whether the vaccine has induced antibodies that block infection of the virus and thereby answer critical questions in the vaccine development process.” Current COVID-19 diagnostic tests available through governments and commercial laboratories determine whether a person is infected by the virus. The UTMB research focuses on prevention through vaccine development by creating technology that helps determine the effectiveness of a vaccine candidate protecting a person from COVID-19. The planned approach is to develop a high-throughput method to measure neutralizing antibody concentrations, the gold standard method for determining vaccine effectiveness. “We are pleased to support UTMB in this important research to develop the COVID-19 assay that, once available, may help accelerate vaccine development,” said Kevin Jones, vice president and general manager, Bioanalytical, ADME, and Vaccine Laboratories for Q2 Solutions. “We are excited to take the assay developed from this research collaboration to production in our labs and enable vaccine developers to use it for large-scale human clinical trial testing to drive toward an effective COVID-19 vaccine.” ]]> https://biospectrumindia.com/news/97/16023/four-neuberg-labs-get-icmr-approval-for-covid-19-testing-.html https://biospectrumindia.com/news/97/16023/four-neuberg-labs-get-icmr-approval-for-covid-19-testing-.html Wed, 25 Mar 2020 15:50:00 +0530 Neuberg Diagnostics Private Limited, a StartUp in the PathLab chain segment has announced the commencement of COVID testing in its Neuberg Ehrlich Laboratory, Chennai post the approval from ICMR. Neuberg is the only Lab Chain in India, whose 4 facilities have been approved by ICMR and will offer COVID – 19 RT PCR tests through its laboratory in Ahmedabad (Neuberg Supratech), Bangalore (Neuberg Anand), Chennai (Neuberg Ehrlich) and Pune (Neuberg AG). Commenting on the development, Dr. GSK Velu, Chairman & Managing Director, Neuberg Diagnostics Private Limited said “COVID-19 has been declared a global emergency by the World Health Organization, as the outbreak continues to spread beyond China. India is currently between Stage 2 and Stage 3 of the disease spread. The Government of India is taking the right measures to curtail its spread. Neuberg is happy to support its efforts towards testing of a symptomatic individual currently and later asymptomatic individuals, as it may be required to augment the travel ban, identify individuals with the infection, isolate them so that the virus can be curtailed.” “We have also set up a special support fund for the weaker sections of the society. Through this we will offer free of cost testing to people with a BPL ration card and appropriate doctor prescriptions,” added Velu. Neuberg will be scaling up its capacity up to 2000 to 2500 tests per day as per ICMR guidelines by next week. Dr. Saranya Narayan, Technical Director & Chief Microbiologist, Neuberg Diagnostics Private Limited said, “Neuberg Ehrlich Laboratory, Chennai has started collecting COVID samples from the lab as well as home from 8 am to 4 pm. The mandatory requirement is the Identity and Address proof, Requisition/Prescription from Physician with their Medical registration number. Neuberg will provide reports within 24 hours in Ahmedabad, Bangalore, Chennai and Pune and within 48 hours from other cities subject to uninterrupted courier movements.” “Reporting and sample acceptance will be strictly in accordance with the ICMR guidelines and will follow ICMR prescribed MRP of INR 4500,” she added. Home pick will also be done through PPE equipped phlebotomists in these four cities. The COVID-19 testing in Neuberg’s labs will follow guidelines by ICMR and other competent government agencies. COVID–19 samples from hospitals, nursing homes, and other healthcare providers can be tested in the labs.  As per the guidelines issued by ICMR for COVID-19 testing in private laboratories, Neuberg will provide the test to an individual only when prescribed by a qualified physician, while also adhering to the sample collection and testing guidelines set by ICMR. All COVID-19 positive samples will be transported to ICMR-NIV (National Institute of Virology), Pune under suitable Biosafety and Biosecurity precautions as laid down by ICMR.   ]]> https://biospectrumindia.com/news/97/16015/16-private-labs-now-testing-covid-19.html https://biospectrumindia.com/news/97/16015/16-private-labs-now-testing-covid-19.html Tue, 24 Mar 2020 14:10:00 +0530 On March 23, Indian Council of Medical Research (ICMR) has given green signal for conducting COVID- 19 tests to 16 private labs in seven states.   A total of 20,864 samples from 19,974 individuals have been tested for SARS-CoV2 as on March 24, 2020 10:00 AM IST. A total of 482 individuals have been confirmed positive among suspected cases and contacts of known positive cases.   List of private labs  Delhi (3) Lal Path Labs, Block -E, Sector 18, Rohini, Delhi Dr Dangs Lab, C-2/1, Safadarjung Development Area, New Delhi Laboratory Services, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi Gujarat (2) Unipath Specialty laboratory limited, 102, Sanoma Plaza, Opposite Parimal Garden, Besides JMC House, Ellisbridge, Ahmedabad Supratech Micropath Laboratory & Research Institute Pvt Ltd, Kedar, Ahmedabad Haryana (2) Strand Life Sciences, A-17, Sector 34, Gurugram SRL Limited, GP26, Sector 18, Gurugram Karnataka (1) Neuberg Anand Reference Laboratory, Anand Tower, #54, Bowring Hospital Road, Bengaluru Maharashtra (5) Thyrocare Technologies Limited, D37/1, TTC MIDC, Turbhe, Navi Mumbai Suburban Diagnostics (India) Pvt. Ltd., 306, 307/T, 3rd Floor, Sunshine Bld., Andheri (W), Mumbai Metropolis Healthcare Ltd, Unit No. 409-416, 4th Floor, Commercial Building-1, Kohinoor Mall, Mumbai Sir H.N. Reliance Foundation Hospital and Research Centre, Molecular Medicine, Reliance Life Sciences Pvt. Ltd., R-282, TTC Industrial Area, Rabale, Navi Mumbai SRL Limited, Prime Square Building, Plot No 1, Gaiwadi Industrial Estate, SV Road, Goregaon, Mumbai Tamil Nadu (2) Dept. of Clinical Virology, CMC, Vellore Department of Laboratory Services, Apollo Hospitals Enterprise Ltd, Chennai Telangana (1) Laboratory Services, Apollo Hospitals, 6th Floor, Health Street Building, Jubilee Hills, Hyderabad   ]]> https://biospectrumindia.com/news/97/16010/cdsco-approves-covid-19-pcr-kit-by-mylab.html https://biospectrumindia.com/news/97/16010/cdsco-approves-covid-19-pcr-kit-by-mylab.html Tue, 24 Mar 2020 02:05:00 +0530 As India fights back the epidemic COVID-19 (aka Coronavirus), limited testing facilities and expensive testing kits has become the biggest concern for the authorities. In order to combat this challenge, the Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd which specializes in molecular diagnostic kits has developed the first made in India test kits for COVID-19 in a record time of six weeks. The kit is the first one to receive commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit. Further, Mylab is the only Indian company to have achieved 100% sensitivity and 100% specificity in the ICMR evaluation. Hasmukh Rawal, Managing Director, Mylab Discovery Solutions, said, “With emphasis on ‘Make in India’ and support from local and central government,  the COVID- 19 kit, has been made as per WHO/CDC guidelines. It was developed and evaluated in a record time”. He further added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable. Mylab has an experience of several years in manufacturing of RTPCR kits and manufactures a range of  kits at the facility approved by Indian FDA/CDSCO and compliant with MDR 2017 regulation for manufacturing medical devices of Class C and D, the most stringent and regulated products by the government, Mylabcurrently manufactures ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits. Apart from this, Mylab has received clearance from Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit, in the same facility. The Mylab COVID-19 kit has been evaluated at Indian Council of Medical Research (ICMR).  “We have been trying hard to make cutting edge technology available to our country at a reasonable and affordable price. Since this test is based on the sensitive PCR technology, even early stage infection can be detected, with highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too”, said Mr. Shailendra Kawade, Executive Director at Mylab. Currently India ranks lowest in terms of testing done per million population. The number is as low as 6.8. Countries like South Korea and Singapore have been able to contain the growing number of Coronavirus cases by doing more and more testing. So far the Indian government is sourcing millions of testing kits from Germany to facilitate testing to diagnose Coronavirus patients PAN India. However, the dependency on foreign kits has been troublesome and supply is getting blocked due to grounded airlines. This can change with the approval for made in India kits.  Mylab promised that it can manufacture up to 1 lakh tests in a week which can be further scaled up if needed. Further, the company claims that its test kits can test about 100 patients with one kit. An average lab with automated PCR can test more than 1000 patients a day.  With local sourcing of test kits it will be a major breakthrough for India as the testing kit by Mylab would cost nearly one fourth of the current procurement cost. Moreover, Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to 7+ hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions in the same time on one machine.  The Mylab manufacturing facility, approved by FDA/CDSCO is compliant with MDR 2017 regulation for Manufacturing Medical Device of Class A,B,C and D and ISO 13485: 2016 certification   ]]> https://biospectrumindia.com/news/97/16008/aimed-welcomes-promotion-of-domestic-manufacturing-of-medical-devices-in-country.html https://biospectrumindia.com/news/97/16008/aimed-welcomes-promotion-of-domestic-manufacturing-of-medical-devices-in-country.html Mon, 23 Mar 2020 15:20:00 +0530 The Union Cabinet chaired by the Prime Minister, Narendra Modi has approved the following schemes recently for promotion of the Domestic Manufacturing of Medical Devices in country: The scheme on Promotion of Medical Device Parks for financing Common Infrastructure Facilities in 04 Medical Device Parks with financial implications of Rs. 400 crore. The Production Linked Incentive (PLI) Scheme for promoting domestic manufacturing of medical devices with financial implications of Rs. 3,420 crore. Applauding the Govt. and thanking the Prime Minister during a video conference Rajiv Nath, Forum Coordinator, AIMED on behalf of the Indian Medical Device Industry said “We congratulate the Government wholeheartedly for approving the much needed schemes for promotion of the Domestic Manufacturing of Medical Devices in country and thanked the Prime Minister for recognition of the need to have self-sufficiency in India in Medical Devices.” He appraised the Prime Minister of the steps being taken by DoP & NPPA & DoCA in addressing the accessibility to raw material issues which were holding back manufacturers from fully utilising their production capacities as well as the need for local administration at various states to recognise the need for medical devices to be treated as an essential product and no steps to be taken to hamper movement of men and materials to produce or sell them but instead to facilitate the import of raw materials and components by cargo airfreight if passenger flights were restricted as well as by continuing courier services. “We are more than hopeful that these schemes announced would help boost local manufacturing and will accelerate medical devices manufacturing as a 'Make in India' enabler, make quality healthcare accessible and affordable for common masses, enable placing India among the top five medical devices manufacturing hubs worldwide and help end the 80-90 per cent import dependence forced upon us and an ever increasing import bill of over Rs 38,837 crore”, he opined Such a visionary move by the Govt. will help address Indian National Healthcare security concerns – the inadequacy of which is being exposed in ongoing crisis to address the Coronavirus pandemic preparedness but the domestic industry was rising to the challenge to meet the health care needs of the country whether masks, gloves, sanitizers, injection syringes or ventilators and oxygen lines.  He stated, we further await policy announcement on the below vital issues of Indian Medical Devices Industry: must ensure consumers are not hurt by shortages by monitoring of prices at import or at ex-factory level and of the MRP and proactive steps taken to regulate prices but not overly so that it leads to further shortages and become non remunerative for manufacturers and traders.  Need to Regulate all Medical Devices under a Patients’ Safety Medical Devices Law separate from Drugs to protect patients and aid responsible manufacturing.  Restriction on Import of Pre-owned Medical Equipment While we thank the Govt of deploying 5% Cess on some imported devices to encourage employment and Make in India of Medical Devices, to address 70-90% import dependency we seek a predictive nominal tariff protection policy as done for mobile phones to ensure a vibrant domestic industry & competitiveness and price stability driven by competing domestic players Need to incentivize Quality in Healthcare Products in public healthcare procurements by preferential pricing for Q1 e.g. ICMED (QCI’s Indian Certification for Medical Devices) instead of L1 (lowest price) to ensure patients access acceptable quality.  The Prime Minister was highly concerned about the highly contagious coronavirus infection which had extended its imprint to 283 cases in India on Saturday and had sought cooperation from Pharma Associations – IPA, IDMA, BDMA etc, AIOCD and Medical Devices Association AiMeD during the all India VDO Conference. With the rapidly growing number of positive infected coronavirus cases in India, one of the major challenges the country is needlessly facing are avoidable shortage of safety masks made worse by anxious civilians hoarding medical supplies though these are not prescribed for healthy individuals and need to educate them. Public is panicking and hoarding up masks and other equipment, leaving limited supplies for health care professionals who need the gear the most. We are creating an avoidable supply chain diversion from supplies to Healthcare workers who are at greater coronavirus risk. Who will protect those who protect us?”, Rajiv Nath said. We are ramping up capacity utilization with assistance of Govt. to address raw material bottlenecks of alcohol, non-woven material and assure availability but appeal to consumers not to buy needlessly and hoard products”, added Mr. Nath. Another critical issue is with demand rising more than 10 times by this individual consumers rush , the country is not only witnessing surge in prices of medical masks and hand sanitiser but the domestic market is now flooded with sub-standard and low-quality products as some retailers and unorganised mask manufacturers are cashing in on the virus terror. Mr. Shinde President of AiOCD affirmed to the Prime Minister that together with AiMeD Association of Indian Medical Devices Industry we have pledged to not charge beyond MRP and assure the government to work against profiteering and black marketing and hoarding.  “The government has thankfully quickly taken some much needed drastic and bold steps to curb the unethical behavior in the market, but lot needs to done by all of us – Manufacturers, Traders & Consumers to address the challenge of avoiding shortage of masks for the healthcare professionals and of Sanitizer to the Consumers and ensure availability at reasonable prices and quality products to jointly fight Coronavirus.” Concluded Mr. Nath. ]]> https://biospectrumindia.com/news/97/16000/cosara-receives-license-for-covid-19-diagnostic.html https://biospectrumindia.com/news/97/16000/cosara-receives-license-for-covid-19-diagnostic.html Mon, 23 Mar 2020 09:05:00 +0530 US based Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced on 19 March that Ahmedabad based CoSara Diagnostics Pvt Ltd, its joint venture for manufacturing in India, has received a license from the Central Drugs Standards Control Organisation (CDSCO) to manufacture RT-PCR COVID-19 test kits. The kits are expected to be sold in the Indian market, as well as for export to the surrounding regions. CoSara has aligned itself with the “Make in India” initiative introduced in 2014 to transform India into a global design and manufacturing hub, and senior officials from the health department expedited the approval process for the license.  The COVID-19 test kits approved by the CDSCO were those originally designed by Co-Diagnostics, the first U.S. company to receive a CE marking for a COVID-19 diagnostic. “The high-quality tests built on our patented CoPrimer™ technology will have a positive impact on what is projected to be the largest healthcare market in the world,” said Dwight Egan, CEO of Co-Diagnostics. “Co-Diagnostics is honored that our joint venture has achieved such a significant milestone.” Mohal Sarabhai, Director of CoSara, remarked “Presently there are 52 government-approved testing facilities and delivering the kits to those is the first target,” in addition to pursuing 60 accredited private labs to conduct COVID-19 tests. “Overall, our target market will be private as well as government labs.” ]]> https://biospectrumindia.com/news/97/15984/icmr-enables-more-diagnostic-labs-for-covid-19-testing.html https://biospectrumindia.com/news/97/15984/icmr-enables-more-diagnostic-labs-for-covid-19-testing.html Thu, 19 Mar 2020 10:10:00 +0530 Indian Council of Medical Research (ICMR), the apex health research body of India has activated more laboratories to test for COVID-19 and revised the testing criteria for the same. The Council has equipped 72 of its laboratories to test for the pandemic disease. In addition to these labs 49 more laboratories under organizations like Council of Scientific & Industrial Research (CSIR), Department of Biotechnology (DBT), and Defence Research, Development Organisation (DRDO) would be equipped to test for COVID19 by end of this week. ICMR will also be setting up two testing locations (NCR and Bhubaneswar) for high throughput diagnostic systems for exponentially increasing rapid diagnosing of COVID-19. These systems can test up to 1400 samples in a day. ICMR is having a dialogue with high-quality private labs that includes labs accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) to understand the modalities of increasing access to the test in the endeavour to prepare for future. ICMR has also revised the testing criteria for COVID-19 under which an individual should home quarantine themselves for 14 days if they qualify for the following conditions: 1. Direct close physical contact of laboratory confirmed positive case 2. History of travel in last 14 days to high risk COVID-19 affected countries ]]> https://biospectrumindia.com/news/97/15938/ottobock-brings-bionic-prosthetics-for-indian-amputees.html https://biospectrumindia.com/news/97/15938/ottobock-brings-bionic-prosthetics-for-indian-amputees.html Thu, 12 Mar 2020 00:00:00 +0530 Orthopaedic surgeon Dr. Aditya Khemka along with Ottobock, a global leader in prosthetics recently introduced the Osseointegration technology as a disruptive, innovative procedure to help amputees in India return to an active social and economic life. India records a large number of individuals with various disabilities with a roughly 0.62 amputees per thousand population. Osseointegration is a radical procedure where a skeletal connection with prosthetics is achieved through a titanium implant in the bone of the amputee. This creates an interface that connects directly onto a prosthetic limb. The resulting bionic leg – in which bone and muscle growth around the upper part of the rod and a system of hydraulics, and microprocessors drive the lower limb – allows amputees to control the limb more intuitively, almost naturally.  Ottobock was chosen for its robust 100-year history of med-tech expertise in the global amputation treatment and rehabilitation space. Pioneering the technology for wearable human bionics, the healthcare multinational is committed to improving the lives of its consumers by helping them gain mobility freedom while preventing potential complications. Ottobock offers a range of custom made prosthetic with advanced technology that includes microchip fitted prosthetics and a mobile application to monitor movements. They have around 30 centres around the country. Currently, all their prosthetics are produced in Germany. Mr. Bernard O’Keeffe, Managing Director & Regional President, Asia Pacific, Ottobock added, “Otto Bock is achieving new frontiers in amputation care. In India, we have always tried to use our global experience to find locally suitable solutions while leveraging cutting-edge technology. If after osseointegration, an inexperienced or unskilled healthcare professional fits the prosthetic components, it can lead to an adverse impact on the implant and the outcomes can be damaging for the patient. We, therefore, ensure that we draw from 100 years of our company’s experience and use globally established protocols to fit osseointegration patients with prostheses.” He also shared his future plans for ottobock's production of prosthetics in India, following a collaboration with Government of India to open up a production facility in Kanpur. Speaking on the life-changing potential of the surgical innovation, Dr Aditya Khemka, Orthopaedic Surgeon with super-specialisation in Osseointegration, who also chaired the event, commented, “Osseointegration is a new dimension to the process in which amputation reconstruction is done. The most important and hence a ‘bottleneck’ part of the prosthesis is the socket. The socket is custom made and skill dependent whereas components like knee and foot are prefabricated and standardised. So if the socket is not right, even with the best of components, the prosthesis will not deliver a complete outcome. Osseointegration deletes socket issues leaving no scope for skin break-downs or discomfort. It offers many other benefits like quick removal and wearing of the prosthesis, better ‘feel’ of the ground below due to direct bone contact, etc. The outcome is always improved energy transfer and control of the prosthetic leg restoring mobility in the patient. Presently only 6 surgeons all around the world are trained to perform osseointegration and around 800 people globally have benefitted from it. It costs around more than 6-7 lakhs depending on the individual amputee and the complications. In India, Dr Aditya operates out of Hinduja hospital in Mumbai, the only centre in India where it can be performed currently. He shared that as this process becomes more common and more doctors are trained to perform it countrywide, the costs can be brought down to what it usually costs for traditional prosthetics. ]]> https://biospectrumindia.com/news/97/15935/motilal-oswal-private-equity-to-invest-240-crore-in-molbio-diagnostics-.html https://biospectrumindia.com/news/97/15935/motilal-oswal-private-equity-to-invest-240-crore-in-molbio-diagnostics-.html Wed, 11 Mar 2020 12:45:00 +0530 India Business Excellence Fund-III, a fund managed and advised by Motilal Oswal Private Equity have agreed to invest upto INR 2,400 million in Goa based research driven diagnostic company, Molbio Diagnostics Private Limited. MOPE Investment Advisors Private Limited (MOPE) is a subsidiary of Motilal Oswal Financial Services Limited (MOFSL), a diversified financial services group with businesses in securities, asset management, private equity and investment banking Molbio (along with its subsidiary Bigtec labs) has developed and commercialized Truenat, the world’s first commercial Point-of-Care (PoC) molecular diagnostics platform using PCR (polymerase chain reaction) technology. Truenat can diagnose 22 infectious diseases (like TB, H1N1, Dengue, HIV, Hepatitis etc.) and has a pipeline of additional 43 diseases (such as Coronavirus, MERS, etc.). This indigenous technology was approved by ICMR in 2018, after 3 years of validation study across various sites in India. Internationally, the World Health Organization (WHO), after conducting a multi-country study, has released a rapid communication in January 2020 endorsing Truenat as initial diagnostic test of MTB and MTB-RIF in view of its high accuracy. Established in 2000, Molbio and Bigtec have spent 18 years on R&D, collaborated with reputed institutions in India and across the globe e.g. CSIR, ICMR, BIRAC, Grand Challenges Canada, BMGF, FIND to develop and deploy molecular diagnostics in resource limited settings. The Truenat assay is rapid (results within 60 minutes) and affordable. The equipment is battery operated and can be used in peripheral centers without extensive infrastructure.     Molbio is working closely with central and state governments across India for supporting the national mission of TB eradication by 2025 and efficient diagnosis of H1N1, Dengue, Hepatitis B & C and other infectious diseases. As per the National Strategic Plan for TB Elimination of India, Government plans to establish over 8,000 molecular laboratories and diagnose over 1.5 crore patients’ annually using molecular tests by 2025. A phase wise roll out with 1,512 Truenat machines has already been initiated. Vishal Tulsyan, Managing Director and CEO of MOPE commented, “We are very proud of partnering with an innovation led company that is likely to change diagnostic paradigm and have real impact on saving millions of life. Molbio has successfully innovated world’s first point of care molecular diagnostic platform and is a true testament to ‘Make in India’ for the world. Molbio’s business model of close ended diagnostic platform with multiple test assays have strong potential across the globe both in public and private sector. Through this partnership, we intend to help Molbio scale up their operations and achieve its vision of becoming a leading and well-respected medical equipment company from India.” Sriram Natarajan, Director and CEO of Molbio said, “Today, India has the highest TB burden across the globe and nearly 1,400 people die of TB every day. TruenatTM will help in decentralizing and democratizing access to high quality diagnostics to millions of patients suffering from TB and other infectious diseases even at peripheral and remote settings. Partnering with MOPE will accelerate Molbio’s growth plans and help the company in scaling its business. The funds would be utilized for fulfilling large committed orders, expansion of manufacturing facility and for other working capital and general corporate purposes.” Chandrasekhar Nair, Co-founder Bigtec, Director and CTO of Molbio said, “Truenat is patented across 100+ countries and has been a result of persistent effort of the dedicated Bigtec team with support from different Indian and global institutions. Truenat enables the transition from presumptive to efficient, real time and precise diagnosis of multiple diseases at reasonable price. Partnership with MOPE will enable us to increase the test menu, build scale and reach to primary healthcare centers and smaller diagnostics labs, which can now deliver high end molecular diagnostic test.” At present, Truenat devices are installed in over 500+ private labs and 350+ primary health centers in India and across the world in 27 countries. WHO endorsement will further enable the product to be commercialized across 150 + countries.   ]]> https://biospectrumindia.com/news/97/15934/kiran-medical-systems-achieves-significant-milestone-in-radiation-protection.html https://biospectrumindia.com/news/97/15934/kiran-medical-systems-achieves-significant-milestone-in-radiation-protection.html Wed, 11 Mar 2020 12:15:00 +0530 Trivitron Healthcare’s Imaging Division, Kiran Medical Systems has achieved a significant milestone in Radiation Protection. The company has announced that all components that can come in contact with the skin, the Fabric, Thread and Edge Binding Fabric used in Kiran’s Radiation Protection Products have been tested and proven to be compliant with International Biocompatibility Quality standards ISO10993-1:2018, ISO 10993-5:2009 (E) & ISO 10993-10:2010(E). Kiran Radiation Protection Aprons are non-sensitizer, non-cytotoxic and non-irritant. Speaking on the occasion, Satyaki Banerjee, CEO-Medical Imaging, Trivitron Healthcare, said, “Kiran being a Global Leader in Radiation Protection is committed to continuous innovation and deliver the absolute best to its customers across the globe with products that set the benchmark standard in terms of scientific differentiation and compliance with International Regulatory norms. Our radiation protection products have evolved over the years with Satin Touch Fabric with Nanotech coating, multi-layer microparticle core materials, magnetic closure systems and now biocompatibility are some of the world’s first that Kiran developed for its customers.” Biocompatibility is a term referring to the tendency of a material being compatible with the living tissue. Any material is said to be biocompatible if it does not trigger a toxic or an immunological response. Cytotoxicity assays are used to assess the effect of the device or its extract on cells grown in vitro. The elution method uses culture medium supplemented with serum as an extracting vehicle and is considered equivalent to the use of both polar and non-polar vehicles. The extracts are transferred onto a layer of cells and incubated for 24 hours. Following incubation, the cells are examined microscopically (qualitative) for their morphology, any malformation or degeneration, and cell lysis. In the quantitative assay, the neutral red (NR) uptake assay procedure is followed, based on the ability of viable cells to uptake neutral red dye. Sensitization (Type IV hypersensitivity reaction) and Skin irritation are key toxicity endpoints to assess the biocompatibility of medical devices. Guinea pig maximization test is the sensitive method to determine the sensitization potential of medical devices, both in terms of induction and elicitation. An assessment is made to know the Skin irritation potential of the material under test to produce dermal irritation in rabbits following topical application. Kiran Satin Touch Fabric was tested successfully for cytotoxicity, skin irritation, and skin sensitization as per ISO’s biocompatibility standard guidelines which provide the framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Kiran Satin Touch fabric is infused with Zinc Pirithione (ZNP) which possesses anti-microbial properties. Radiation protection aprons, accessories and protective gears crafted from Satin Touch offer best fit, comfort and feel and is available in a variety of colour shades. Trivitron’s Kiran portfolio of radiology products include a comprehensive range of Radiation Protection Products, Ultisys range of Mobile & Fixed Digital Radiography systems, Infinity and Elite series surgical C-Arm systems featuring Flat Panel Detector technology, Felicia Digital Mammography, SonoRad V9 & V10 Color Doppler systems, Contrast Media, Anti-scatter X-ray grids and a wide range of Imaging Accessories & Consumables.   ]]> https://biospectrumindia.com/news/97/15917/indian-medical-devices-sector-to-reach-50b-by-2025.html https://biospectrumindia.com/news/97/15917/indian-medical-devices-sector-to-reach-50b-by-2025.html Fri, 06 Mar 2020 11:30:00 +0530 India Pharma and India Medical Device 2020 took place in Gujarat recently. It was jointly organized by FICCI with the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt of India. D V Sadananda Gowda, Minister of Chemicals and Fertilizers; Vijay Rupani, Chief Minister, Gujarat; Mansukh Mandaviya, Minister of State (I/C) for Shipping and Chemicals & Fertilizers; Dr P D Vaghela, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers; M K Das, Principal Secretary, Industries & Mines Department, Government of Gujarat; Pankaj R Patel, Past President, FICCI & Chairman, Zydus Cadila; Badhri Iyengar, Chairman, FICCI Medical Device Forum along with policy makers, national and international leaders from medical technology industries, academic and research fraternity were part of this conference. D V Sadananda Gowda said that the Indian pharmaceuticals and medical devices sector has the potential to become the world leader and government will provide all necessary support. Indian medical devices sector can reach $50B by 2025, he added. India today is a major hub for medical devices and diagnostics. There has to be certain interventions by the government as far as polices are concerned. Affordability of the medicines is one of the prime concerns of the society. “In developing countries where a large section of population is poor and out of pocket expenses are very high, affordability of the medicines is one of the prime concerns of the society,” he added. He emphasized that government is making all efforts to boost the Indian pharma and medical devices sector and added, “In countries where R&D are taken care of, where academia and industry collaborate in order to build a strong R&D eco-system. In India, we need to follow this. Government has initiated various steps for strengthening the Indian pharma and medical devices sector.” Speaking on the COVID-19, he said that it is challenging times and we should all stand together at this time. Govt has and is taking all necessary steps in this direction. There is no shortage of medicines. We have sufficient medicines and sufficient APIs so that for another three months to ensure there is no shortage in producing medicines. Vijay Rupani while highlighting the state’s contribution to the national GDP said that Gujarat is one of the few states in the country to provide all necessary support to strengthen the pharma and medical devices companies. He said that the state government is planning to come up with two dedicated parks, one for bulk drugs manufacturing and other for medical devices. “In India, pharma and medical devices sector is growing rapidly. Gujarat has become a hub in manufacturing sector, agriculture and social sector. Now, Gujarat is ready to take the lead in pharmaceuticals and medical devices sector,” added Rupani. Mansukh Mandaviya said, “When the world is in recession, Indian pharma sector is growing at 10 percent and Indian medical devices sector is growing at 20-25 percent. India has lot of opportunities and this is not only encashed by Indian companies, but also global players are also investing in these sectors.” He further added that government is working on bringing new policy to strengthen the Indian API market. Dr P D Vaghela said, “Government will be setting up a ‘Pharma Bureau’, which will help facilitate both foreign as well as domestic investment in the Pharmaceutical and Medical devices industry in India. Pharma Bureau will act as a policy think tank to support the Government as well as the Industry.” M K Das highlighted the growth of Gujarat’s economy and enumerated various policy initiatives which enabled the state to attract 51% of the country’s FDI. Pankaj R Patel, Past President, FICCI & Chairman, Zydus Cadila while highlighting the current challenges of the sector said that this is a wake-up call for the sector. Badhri Iyengar said, "India contributes to 1.2 percent of the global medical device market and about 6 percent of the total healthcare market globally." FICCI-EY report ‘Reshaping India into a life sciences innovation hub’ was also released during the event. Key highlights of the report: 1. India has come a long way in becoming a hub for manufacturing and supply of generic drugs and is today touted as the pharmacy of the world.2. The country is still at a nascent stage in terms of its activities in commercially oriented R&D and innovation. Despite being the third largest seller of medicines in the world, India has been able to produce only a handful of novel commercially viable drug molecules.3. The report examines what it will take to replicate this success to novel products and medical devices: i. Establishing top-down governance structure:Creating a Centre of Excellence (CoE), where stakeholders are able to provide thought leadership and direction to innovators to create commercially viable projects ii. Enabling access to quality infrastructure and talent:Geographical proximity between universities supplying high skilled talent and R&D hubs of industriesEnhancing industry-academia collaborationImproving the education level of the workforces based on industry needs Building sustainable clinical trial infrastructureConstructing dedicated zones or mega drug parks iii. Creating sound and effective IP, legal and regulatory framework:Establish transparent and predictable IP laws and policiesFacilitate knowledge transfer iv. Ensuring availability of financing for research and purchase of medicine:Adopt healthcare financing policies to increase availability and usage of pharmaceutical innovationRisk sharing models are needed to incentivize PE/VC funds for making investments in high-risk life sciences R&D for long-termInnovative financing models (e.g., debt-type instruments) need to be institutionalized by partnering with central banking organizations in the country v. Streamline and fast-track regulatory approval process: To boost the innovation in emerging areas such biosimilars and biologics, initiatives such as decreasing the number of authorities involved or specifying a maximum time-limit for approvals and simplifying the documentation and submission requirement, can help facilitate growth ]]> https://biospectrumindia.com/news/97/15919/mahajan-imaging-inks-collaboration-with-syntheticmr.html https://biospectrumindia.com/news/97/15919/mahajan-imaging-inks-collaboration-with-syntheticmr.html Fri, 06 Mar 2020 10:00:00 +0530 New Delhi based Mahajan Imaging is one of India's most renowned diagnostic imaging centers, and the collaboration agreement is expected to strengthen Swedish firm SyntheticMR's marketing efforts in India. Mahajan Imaging are already utilizing SyntheticMR's solution integrated on GE scanners, sold as MAGiC, to speed up the MR workflow. Now they are adding the latest FDA-cleared quantitative imaging solution, SyMRI, to many of their clinical protocols. "This provides a great tool for challenging clinical cases, for example screening premature children or in the follow-up of patients with neurodegenerative diseases such as dementia and Alzheimer's," says Dr Sriram Rajan, Head of MR research at CARING, the R&D division of Mahajan Imaging.  "CARING has also been actively working on establishing new use-cases of MAGIC outside the brain. We have a presentation on using MAGIC for Quantitative Cartilage Mapping at the European Congress of Radiology in July," added Dr. Rajan. "We see great potential in quantitative MRI on the Indian market," says Ulrik Harrysson, CEO at SyntheticMR. "Working together with Mahajan Imaging will further support our sales and marketing efforts in India." ]]> https://biospectrumindia.com/news/97/15882/nppa-grants-non-applicability-of-dpco-2013-to-meril-life-sciences-for-meres100-brs-.html https://biospectrumindia.com/news/97/15882/nppa-grants-non-applicability-of-dpco-2013-to-meril-life-sciences-for-meres100-brs-.html Mon, 02 Mar 2020 10:40:00 +0530 In February 2017, all stents were subject to price regulation as per the provisions of Drug Price Control Order (DPCO) 2013. However, Para 32 of DPCO 2013, allows innovative products exemption from applicability of all DPCO 2013 provisions for a period of 5 years from the commencement of commercial production in India. To qualify, the product must be a new drug, as well as patented under the Indian Patent Act (1970). Since its innovative product MeRes100TM BRS - Sirolimus Eluting Bioabsorbable Vascular Scaffold System fulfils these criteria, Meril Life Sciences applied to NPPA for non-applicability of DPCO 2013 on May 28, 2018, and the exemption has been granted on February 25th 2020. Sanjeev Bhatt, Vice President-Corporate Strategy, Meril Life Sciences said, “The positive decision by NPPA confirming non-applicability of DPCO 2013 under Para 32 for MeRes100 BRS, made post an exhaustive multi-stakeholder review, demonstrates the commitment of the Indian Government to encourage not only ‘Make in India’, but also ‘Research in India’. An extensively researched innovation, MeRes100 BRS is backed by 3-year efficacy and safety clinical trial data, has received 8 patents worldwide, CE mark approval and a DCGI granted 122E new drug approval that attests to its efficacy and safety for the indicated use. We are committed to introducing MeRes100 BRS in India and the world responsibly by undertaking a range of measures to ensure effective access and right use, including conducting a 2000-patient large scale randomized study, building 1000-patient Indian and global patient registries and ongoing education of interventional cardiologists.” MeRes100 BRS addresses a specific unmet clinical need and there is rigorous research to back its benefits. The rate of coronary heart disease in young Indian men is almost twice as high as that in their western counterparts and there is evidence that CVD begins to affect Indians at least a decade earlier than it affects Europeans. Implanting metallic stents permanently in younger patients is undesirable, as there is a risk of adverse events occurring year on year. Moreover, multiple studies have proven that thinner stents promote faster healing (endothelialization) and are associated with reduced risk of clinical events such as stent thrombosis, restenosis and revascularization i.e., repeat procedures. By defining this clear unmet clinical need – on the one hand to provide a bioresorbable scaffold, and on the other to ensure thin struts to reduce risk, Meril leveraged its expertise in innovation and R&D to develop MeRes100 BRS – the world’s first thin-strut BRS. There is extensive evidence to show the therapeutic advantages MeRes100 BRS offers, based on which MeRes100 BRS has obtained DCGI 122E new drug approval and CE (European conformity) marking approval. Across MeRes-1 (a trial conducted in India) and MeRes-1 Extend (a trial conducted in Brazil, Europe and Asia), MeRes100 BRS has shown long-term positive safety and sustained efficacy outcomes for patients with coronary artery disease in treatment of de-novo coronary artery lesions. Both trials have validated the intended benefits by demonstrating virtually complete strut coverage, zero scaffold thrombosis and very low major adverse cardiac event (MACE) rates of 1.87% in MeRes-1 at three years and 1.61% in MeRes-1 Extend at two years. Given the innovative nature of this technology, Meril Life Sciences decided to go beyond the regulatory requirement of 1-year follow-up data to produce longer-term data on the safety of MeRes100 BRS. Now, with even 3-year follow-ups confirming the initial findings of zero stent thrombosis and extremely low MACE, Meril Life Sciences is ready to launch this technology shortly. In parallel to commercial launch, the following actions will be taken: Establishment of a 1000 patient registry in India and 1000 patient registry globally. This will enable acute and long-term surveillance, safety and efficacy assessments and assessment of performance in a real-world clinical setting. Conducting randomized long-term clinical trials in India and globally across US, China and other sites to further establish the efficacy and safety of BRS. This will include a 2000 patient randomized controlled trial comparing BRS to best in class metallic DES technology. Supporting the use of MeRes100 BRS through ongoing doctor education, including training of HCPs in profiling and selection of the right patients to ensure use as per indication, as well as implantation and imaging protocols that are crucial for successful implantation of BRS. Ensuring sequential hospital roll-out, which will facilitate development and cascade of clinical best practices across centers of excellence to other hospitals, ultimately to ensure the best possible outcomes for patients.     . ]]> https://biospectrumindia.com/news/97/15880/expanding-the-scope-of-heart-care-with-advanced-imaging-tools.html https://biospectrumindia.com/news/97/15880/expanding-the-scope-of-heart-care-with-advanced-imaging-tools.html Mon, 02 Mar 2020 10:05:00 +0530 Turning a corner in interventional cardiology, advanced tools have opened new frontiers in heart care. Even as India is home to the highest burden of cardiovascular diseases (CVDs) with changing lifestyles leading to a dramatic shift in the CVD patient profiles, doctors are now looking at newer tools to address the burgeoningburden. Leading experts from the various fields of interventional cardiology came under one roof to discuss the most advanced percutaneous cardio vascular interventions at the 11 th India Live national conference in New Delhi from Feb 28 to March 1 with focus on &Interventional Cardiology: From Clinic to Cutting Edge”. Emphasizing on the biggest challenges faced by cardiologists today, and the role played by latest imaging techniques, Dr. Nils P Johnson: Associate Professor of Cardiology, University of Texas, Houston. USA said, “Lifestyles are changing and as doctors, we come across complex Cardiovascular diseases (CVDs) manifestations every day. Hence, latest modalities become particularly important in dealing with these complexities to ensure better patient outcomes. For instance, we have technologies like Fractional Flow Reserve (FFR) that help us decide in advance if the artery needs a stent or not. Such tools are provided bysome of the leading names in healthcare. In India, we must ensure our patients have access to these technologies.” Today, heart failure is the leading cause of mortality amongst all heart diseases in India. With 23 per cent patients succumbing within one year of their diagnosis, experts underline the need to look at technological interventions from around the globe to address this burden. “One in four deaths in India are now because of CVDs with ischemic heart disease and stroke responsible for over 80% of this burden. Cutting-edge technologies provided by global leaders like Abbott are offering imaging techniques that are specifically designed to offer physicians the greatest practical advantages when performing percutaneous coronary intervention (PCI). Doctors rely on these tools to give them precise results.” “It is encouraging to see how technology is transforming the way we treat patients. We have tools like Optical Coherence Technology (OCT) that help us assess the extent, nature and exact location of the blockage. Apart from helping us choose the right stent, OCT also helps in the post-implantation process to ensure that the stent is placed properly and expanded well. We need such advanced tools for better patient outcomes,” shared Dr. Krishna Sudhir, Divisional Vice President Medical Affairs at Abbott. Turning the focus to improved diagnosis with technologies such as Optical Coherence Tomography (OCT), Dr. Shirish (M.S.) Hiremath, Consultant Cardiologist & Director – Cath Lab, Ruby Hall Clinic, Pune mentioned, “Advanced tools like OCT are allowing us to visualize the minutest details inside the vessel and get the exact assessment of the blockage. Even today, most of the world uses angiography which gives us only a two- dimensional view of the coronary artery. We need new technology to help optimize the treatment, and that is what new technology is providing. We can get a 3D view of the blocked artery with OCT. It also helps us decide the kind of stent we should choose.” Whether it’s the validation a doctor needs in choosing the stent or post-procedure risk assessment, advanced technologies like FFR and OCT are helping doctors make precise decisions, resulting patient outcomes. “I treat a lot of complex heart disease patients using advanced technologies like Fractional Flow Reserve FFR and OCT. These latest tools are becoming important in achieving precision PCI and are now an inherent part of my routine clinical practice. FFR is a guiding tool used world over for assessing whether the artery needs to be stented or not. It gives a score which helps physicians decide the treatment strategy. It is the first line of assessment in highly developed countries like the USA and Japan having the highest level of evidence and it’s part of international guidelines ESC,” concluded Dr Nils P Johnson: Associate Professor of Cardiology. University of Texas, Houston. USA. ]]> https://biospectrumindia.com/news/97/15869/vimta-labs-sets-up-coe-for-bioassays.html https://biospectrumindia.com/news/97/15869/vimta-labs-sets-up-coe-for-bioassays.html Fri, 28 Feb 2020 10:10:00 +0530 Hyderabad based Contract Research and Testing Organization, Vimta Labs has conducted Confluence - 2020, a knowledge sharing session to sensitize pharma industry about upcoming regulatory and scientific developments. The theme of the event was development of large molecule drugs also called as biologics. Scientists and researchers from various parts of the globe have interacted with the participants about the developments in their respective areas of research. Welcoming the participants to the event, Suresh Kumar, President of Vimta Labs said, “The last decade has seen a substantial shift in the focus of pharma industry from small molecules to large molecules. Biologics is changing the way doctors treat diseases and health conditions that have eluded us over the years & are now helping us improve the Quality of Life. This change is more pronounced in the case of cancer, autoimmune and infectious diseases.” He also announced that, “With the increasing emphasis on large molecule drugs, we have established a dedicated state-of-the-art facility for biologics development. We are proud to announce that Vimta has set up a Centre of Excellence for Bioassays.” ]]> https://biospectrumindia.com/news/97/15859/members-are-ready-to-brace-up-for-any-shortages-in-medical-equipment-mtai.html https://biospectrumindia.com/news/97/15859/members-are-ready-to-brace-up-for-any-shortages-in-medical-equipment-mtai.html Thu, 27 Feb 2020 10:55:00 +0530 Medical Technology Association of India (MTaI), which represents research-based medical technology companies with a large footprint in manufacturing and training in India, recently said that its member companies are ready to brace up for any shortages in medical devices and equipment arising out of scarcity of raw materials from China. With the shortages of raw materials from China, there may soon be a scarcity of commonly used medical devices like digital thermometers, infrared thermometers, nebulizers, blood pressure monitors and glucometers manufactured in India as reported by the Press. The supply lines may not sustain as the geographies affected are spreading. The wide spectrum of medical devices and equipment that MTaI members have, remained unaffected as these companies do not depend on imports from China. Pavan Choudary, Chairman, MTaI and Managing Director, Vygon India said, “MTaI members will try and offset any supply gaps arising out of the import shortages from China. MTaI member companies’ products conform to the highest quality standards and are imported primarily from USA, Europe and Japan or manufactured under strict quality control in India”. Medical Technology Association of India (MTaI) is an association of research-based medical technology companies who have made remarkable investments in Manufacturing, R&D and Health Care Workers Training in India. ]]> https://biospectrumindia.com/news/97/15835/thyrocare-brings-blood-based-cancer-screening-profile.html https://biospectrumindia.com/news/97/15835/thyrocare-brings-blood-based-cancer-screening-profile.html Mon, 24 Feb 2020 13:20:00 +0530 Thyrocare, a leading provider of wellness tests, has announced the launch of Cancer Screening Profile. This consists of ‘Easycheck360™’, a cancer screening test for the early detection of 16 types of cancers that is processed by Datar Cancer Genetics (Datar), and Thyrocare’s popular wellness profile ‘Aarogyam’, which is available for Rs. 8999. Cancer screening through blood is a breakthrough, patented and pioneering test by Datar which is clinically proven in the world’s largest study with over 44,000 patients. The research data has been published and acknowledged by the International Journal of Cancer and other leading cancer journals. Datar’s cancer detection technology is based on the discovery of the new systemic hallmark of cancer i.e. Circulating Tumor Cells and their clusters (C-ETACs) which are extensively present in cancer patients much before any clinical evidence can manifest and virtually undetectable in asymptomatic individuals. Two clinical trials registered in India have shown a sensitivity of 90%, specificity of 97% and overall accuracy of 94% to detect C-ETACs. The test requires just 10 ML of blood and the results are provided within 10 days. Thyrocare’s Aarogyam is an array of well accepted, cost effective wellness packages. It offers high quality investigations for many metabolic disorders, which have evolved over the last 20 years with a collective experience of testing 15 crore customers and 750 crore investigations. Thyrocare services and networks are present in 3000 locations across 10 countries. Dr. Velumani, CEO of Thyrocare, said, “Cancer, the growing and most devastating disease, has no reliable screening tests for early diagnosis so far. Easycheck360™ launched by Datar Cancer Genetics has the potential to fill in the void and can impact early cancer diagnosis immensely. Cancer Screening Profile is a logical combination of Easycheck360™ and Aarogyam that anybody over 35 years should consider annually.” Mr. Rajan Datar, Managing Director of Datar Cancer Genetics, said, “Easycheck360™ is a breakthrough test for the detection of most solid organ cancers such as breast, ovary, lung, colon and liver cancers. Our technology is very sensitive and specific to detect Circulating Tumor Cell clusters in the blood, which is by far the most powerful evidence of malignant activity in the body.” ]]> https://biospectrumindia.com/news/97/15832/iqvia-launches-avacare-clinical-research-network.html https://biospectrumindia.com/news/97/15832/iqvia-launches-avacare-clinical-research-network.html Mon, 24 Feb 2020 09:25:00 +0530 IQVIA, a leader in human data science, has announced the launch of Avacare Clinical Research Network™, a technology-based global site network that opens opportunities for more clinical trials at experienced clinical and research sites. Avacare’s unique analytical tools help sites in Avacare’s network match patients to clinical trials faster and more effectively. Previously known as Qcare, Avacare has now expanded to include sites in the U.S. and India, with coverage across 19 therapeutic areas. Through existing physician relationships connected to approximately 6.5 million patients globally, Avacare provides innovative treatment options that drive healthcare forward. Avacare uses innovative clinical technology with advanced analytics to deliver artificial intelligence-powered patient referrals and data-driven enrollment trends. By utilizing proprietary algorithms and privacy-protected health records across sites, Avacare precisely identifies the best patients to opt-in for each trial and supports the investigators in engaging patients for those trials. “We believe combining clinical research and patient care produces better patient outcomes, reduces cost of care, and advances research that will benefit patients,” said Cynthia Verst, president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. “This is another example of IQVIA’s commitment to human data science, where our Avacare network enables practices to efficiently match trial participants to clinical trials, advancing medical innovation.” ]]> https://biospectrumindia.com/news/97/15828/26th-edition-of-medical-fair-india-to-be-held-in-mumbai.html https://biospectrumindia.com/news/97/15828/26th-edition-of-medical-fair-india-to-be-held-in-mumbai.html Fri, 21 Feb 2020 13:50:00 +0530 The 26th edition of Medical Fair India 2020 to be held from 05-07 March at Bombay Convention and Exhibition Centre in Mumbai. The exhibition and conference for healthcare, which acts as a platform where connections are made and business relationships are nurtured. A part of the "MEDICAlliance" family of trade fairs, it is organised by Messe Düsseldorf India in cooperation with MEDICA.   It is being held in the backdrop when Indian healthcare industry has witnessed a remarkable growth over the last two decades. The foreign investments have made the medical devices market a fast moving sector contributing to the GDP. The Indian healthcare sector is diversifying and opportunities are emerging in every segment. Together with MEDICAlliance and in association with Association of Healthcare Providers, India (AHPI), Association of Indian Manufacturers of Medical Devices (AIMED), Association of Diagnostic Manufacturers of India (ADMI), Quality & Accreditation Institute (QAI), Practicing Pathologists Society, The Association of Practicing Pathologists (APP), Maharashtra Association Of Practising Pathologist & Microbiologists (MAPPM) and this edition promises to bring together all the stakeholders from all facets of Medical and Healthcare Industry. Veena Kohli, President, Association of Diagnostics Manufacturers of India continues to lead the Clinlab conference. The conference will cover topics on In- Vitro Diagnostic, Laboratory medicine, Point of Care Testing, Molecular Medical Diagnostics and Clinical Chemistry. “Medical Fair India is well known for its ability to detect trends and respond to new innovations. Therefore, each edition is unique as it explores new sub-segments and opportunities for diversification” said Thomas Schlitt, Managing Director, Messe Düsseldorf India. Additionally, the future for Health (FTR4H) conference this year at Medical Fair India will focus on how Digital Transformation reconstructs Healthcare. NASSCOM – Center of Excellence – IoT & AI joins this year as its Digital Transformation Partner and jointly with FTR4H will organize the Startup Awards. This year attraction include participation from Startups to showcase their solution in the Healthcare domain. The VOH 5th International Healthcare Conference at Medical Fair India is an important date on the national healthcare calendar. This year, the theme is ‘SYNERGY, IDEA, COLLABORATION: UNLOCKING THE POTENTIAL OF INDIAN HEALTHCARE’. The overarching objective is to mobilize key stakeholders from both public and private sectors – along with their strengths and innovations – on a common platform that can highlight best-ways forward for everyone who holds a stake in the space. rehaindia, powered by REHACARE will continue to feature alongside Medical Fair India. This segment will be dedicated to the rehabilitation sector in India. The three-day event will attract all the categories of stakeholders in this segment. With this move we provide access to our exhibitors to a very big market and our visitors to interesting solutions for all their questions relating to disability. The “Smart Hospitals” platform is created as a new entity this year. The objective is to help the Small and Mid-sized Hospital Owners to rethink their business models, create new opportunities by evolving newer smart ways of delivering healthcare. The intent was to bridge an existing gap as medical conferences hardly ever touch the business side of healthcare. Managers diving in from non-healthcare domain have not understood as to how healthcare should be practiced and delivered. It is high time doctors and doctor managers take charge of this business side.  ]]> https://biospectrumindia.com/news/97/15824/five-companies-get-land-allotted-at-hyderabad-medtech-park.html https://biospectrumindia.com/news/97/15824/five-companies-get-land-allotted-at-hyderabad-medtech-park.html Fri, 21 Feb 2020 11:25:00 +0530 KT Rama Rao, Minister for Industries, Commerce and IT, Govt of Telangana has handed over allotment letters to 5 MedTech companies who are setting up their units at Medical Devices Park in Hyderabad. The companies include Jagore Life Sciences Pvt Ltd, Majik Medical Solutions Pvt Ltd, Arni Medica Pvt Ltd, Trident Technologies and Pulse Pharmaceuticals. The foundation stone for this park was laid down in 2017,at Sangareddy district. "Within a span of 2 years, over 20 companies are expected to set up their manufacturing units and R&D centres in the Medical Devices Park", said Rama Rao.  ]]> https://biospectrumindia.com/news/97/15825/strengthening-medical-equipment-manufacturing.html https://biospectrumindia.com/news/97/15825/strengthening-medical-equipment-manufacturing.html Thu, 20 Feb 2020 21:00:00 +0530 The healthcare machine tool and manufacturing sector comprise of industries making products, equipment, devices, accessories, tools, and surgical instruments offering diagnostic, therapeutic, and related services for the needs of laboratories, hospitals, doctors, medical staff, and patients. Medical technology is evolving rapidly with the development of advanced equipment which includes            features and innovations like high precision, accuracy, reliability, biocompatibility, lightweight, and more. Performance of machinery is critical and uncompromising in the healthcare industry. Currently, India imports approximately eighty percent of the medical equipment used for critical care, imaging, and high-end surgeries apart from surgical tools and other medical devices. These types of equipment when manufactured indigenously include distinct advantages that are primarily economic also enhancing the affordability of the machines. For bridging the gap quickly apart from focussing on building pieces of equipment indigenously for local needs, it is also essential to network and collaborate with reputed global companies to bring advancements in technology to the Indian market. The market size of the medical devices industry in India is estimated to be over five billion dollars and adds about four to five percent to the ninety-six billion dollars Indian health care industry. With the medical devices market projected to reach fifty billion dollars by 2025, the medical industry, which comprises of some seven hundred and fifty to eight hundred medical device manufacturers, is expected to procure more machines. Carrying forward the ‘Make in India’ plan, the Indian government has facilitated to establish multiple medical device parks across several states of the country to support medical technology innovation and manufacturing. These medical device parks will be placed across Andhra Pradesh, Telangana, Kerala, Uttarakhand, and Tamil Nadu to provide world-class treatment at affordable prices. “Demands from the medical sector will increase with the establishment of medical device parks in Andhra Pradesh, Telangana, Tamil Nadu, and Kerala. Furthermore, demand for machine tools will also arise from the various medical hubs in Maharashtra, Gujarat, Karnataka, Andhra Pradesh, Telangana, and Tamil Nadu” says IMTMA Director-General, V. Anbu, highlighting the rise in expected business. The scheme proposes to provide Rs twenty-five crore or seventy per cent of the project cost of setting up CFCs, whichever is less, for the creation of common facilities in any upcoming park. For the establishment of the medical parks, Andhra Pradesh Medtech Zone for the creation of CFCs has recently received a go-ahead for researching superconducting magnetic coil. IMTEX FORMING 2020 & Tooltech 2020 held at the Bangalore International Exhibition Centre (BIEC), Bengaluru, in the last week of January 2020, organized by Indian Machine Tool Manufacturers’ Association (IMTMA) served as a platform for visitors to see technologies ‘live’ and explore its usage, features and functioning and configure the right solutions for the medical industry. It featured exhibitors displaying new machines, products and technologies related to metal forming processes, near net shape manufacturing, die and mold, fixturing, joining, and welding, sheet metal working, CAD / CAM and application software which were of interest for the healthcare sector. Developments in the area of Metal Additive Manufacturing stood as the highlight for the medical sector exhibition. Speaking about the opportunities in medical equipment manufacturing, IMTMA President, Indradev Babu said that government initiatives to strengthen medical devices sector by reducing dependence on imports and provide a single-window mechanism to focus on making India a global hub for production in medical devices interest subsidy for MSMEs, and other have given right directions for machine tool industry to work accordingly. The government’s move to consider the manufacturing of medical equipment as distinct from medicines from a regulatory perspective has helped greatly in manufacturing. We are certain that IMTEX FORMING will satisfy several needs of the medical sector in India. ]]> https://biospectrumindia.com/news/97/15818/telangana-govt-accelerates-indigenous-medtech-innovations.html https://biospectrumindia.com/news/97/15818/telangana-govt-accelerates-indigenous-medtech-innovations.html Thu, 20 Feb 2020 14:50:00 +0530 In order to provide a platform which can enable aspiring entrepreneurs to test their innovative ideas in the field of medical technologies, The Government of Telangana and MedTechConnect, a platform founded by Cyient and Xynteo's India2022 coalition have joined hands together to launch a new initiative called Project Tej. As part of BioAsia 2020, Asia's largest Biotechnology and Life-sciences forum, Telangana State's Research and Innovation Circle of Hyderabad (RICH) and MedTechConnect have signed a Memorandum of Understanding (MoU) in an endeavour to accelerate and support the indigenous innovations in medical technologies. The primary focus of Project Tej is to: Launch testbeds for large scale clinical validation, usability assessment, and business model evaluation in real-world clinical settings for late-stage medical technologies Provide structured mentoring from the industry on design, manufacturing, and commercial access Facilitate market access to validated technologies in public and private healthcare channels. Through Project Tej, medical technology innovators and device manufacturers can validate the usability of their devices in public health settings and gain access to public health channels. Project Tej testbeds will complement Telangana state's infrastructure projects, which include the Telangana MedTech Park and ensure that Telangana becomes a favorable destination for MedTech investments. "Telangana state is now synonymous with innovation and technology. With this initiative, we want to use the expertise available in the state to ensure ground-breaking medical technologies can deliver quality healthcare for all," says Ajit Rangnekar, Director General, RICH. ]]> https://biospectrumindia.com/news/97/15797/syngene-opens-rd-centre-in-hyderabad.html https://biospectrumindia.com/news/97/15797/syngene-opens-rd-centre-in-hyderabad.html Mon, 17 Feb 2020 17:25:00 +0530 Syngene International Limited, global contract research organization has announced the commissioning of the first phase of its new R&D centre in Hyderabad. The centre, located in Genome Valley, is spread across 52000 sq. ft. with an initial strength of around 150 scientists. This is the Company’s first operational research centre outside Bengaluru. When fully commissioned by the end of this year at an investment of Rs. 167 Cr, it will cover a total of 94000 sq. ft. and house around 270 scientists. The centre was inaugurated by K.T Rama Rao, Minister for Industries, IT, MA & UD, Government of Telangana, in the presence of Jayesh Ranjan, IAS, Principle Secretary, Industries and Commerce, Government of Telangana and Shakthi Nagappan, Director (Life Sciences & Pharma) and Chief Executive Officer, Hyderabad Pharma City, together with senior leaders from Syngene. Speaking on the occasion, K.T Rama Rao said, “We are happy that Syngene International Limited has selected Telangana for setting up their new R&D center. This is a testimony to one of the accomplishments of BioAsia which has been able to showcase the immense potential, opportunity, and support the state offers. We have been focusing on the Life Sciences sector and the Genome Valley was conceptualised to provide all the necessary infrastructure and support systems for life science R&D activities. Syngene’s presence is surely a boost for the state’s vision to be a biotech hub.” Kiran Mazumdar Shaw, Managing Director, Syngene International Ltd. said, “We are delighted to set up our new R&D centre in Genome Valley, Telangana, recognised as a leading global biotech hub. I congratulate the Government of Telangana on their vision and pioneering efforts to create an environment that fosters the growth and development of the biotechnology industry." Jonathan Hunt, Chief Executive Officer, Syngene International said, “The inauguration of this site in Genome Valley today marks an important step for the company. With increasing demand for our research services, we needed to find a location that offered the right environment to drive scientific innovation and seamless delivery. This means not just having the ability to build, equip and maintain world class laboratories, we also need to be able to attract top scientists in chemistry, biology, biometrics and other disciplines. Genome Valley has all the requisite infrastructure and a comprehensive science eco-system to allow us to deliver cutting edge, innovative scientific research outside Bangalore for the first time.” Genome Valley is India’s first purpose-built cluster for life sciences R&D activities spread across 600 sq km. Syngene’s new R&D centre is located in MN Park at the heart of the Genome Valley. The new R&D centre is fully digitised based on an internet-based, innovative, analytical laboratory solution that enables anytime, anywhere, monitoring; remote and secure access; and minimizes system downtime by monitoring the operational status of the systems. The centre also has other digitisation and automation features including electronic laboratory notebooks and analytical intelligence. The building benefits from environment-friendly measures such as energy conservation through the use of solar power and limited plastic use. The safety features of the centre include laboratories built with fire-rated walls and panels, a dedicated flame proof area for storage of hazardous materials away from the laboratories and dedicated water lines for fire hydrant and sprinkler systems. Initially, the Company will offer Discovery Chemistry services from Hyderabad. In the next phase, other research services will move to this centre providing research to the world’s leading pharmaceutical companies. Syngene currently operates through multiple facilities in Bengaluru spread across an area of 1.5 million sq ft. comprising state-of-the art research and manufacturing facilities. These facilities have successfully cleared multiple global regulatory inspections including the USFDA, EMA and PMDA. ]]> https://biospectrumindia.com/news/97/15791/lt-expects-50-of-all-surgeries-to-be-robot-assisted-by-2025.html https://biospectrumindia.com/news/97/15791/lt-expects-50-of-all-surgeries-to-be-robot-assisted-by-2025.html Mon, 17 Feb 2020 00:00:00 +0530 L&T Technology Services Limited, India’s leading pure-play engineering services company, expects almost 50% of all surgeries to be robot assisted by 2025, as AI makes robots precise enough to facilitate complex surgeries. LTTS organized an ‘Experience Walk-through’ as part of a Symposium on Advancement in Robot-assisted surgery to enable participants to get hands-on experience with cutting-edge products and solutions in the medical and medical equipment field. The event was graced by prominent dignitaries and speakers in the field of Robotics, Clinical Robotics, Medicine & Healthcare and Medical Equipment from IIT Madras, IIT Delhi, IISc Bangalore, PSG Institute of Medical Science and Research, Coimbatore, PSG College of Technology, Navtat Solutions and Simulated Surgical Systems.The Chief Guest was University of Illinois President, Dr. Timothy Killeen - a distinguished scientist in geophysics and space science, an experienced educator, and a member of the National Academy of Engineering. The symposium was dedicated to discussing the possibilities and advancements in the field of Medical Robotics. Robotics is a state-of-the-art technology that offers superior vision, improved flexibility and great accuracy surpassing humans while performing complex tasks. Robotic assistance in surgery, rehabilitation efforts and therapeutic practices have made humans realize the need for research and technological progress in the field.Experts in the field including Professor Kesh Kesavadas, Director of Health Care Engineering Systems Center at University of Illinois and the inventor of RoSS Robotic Surgery Simulator, the world’s first stand-alone training system for da Vinci surgical system, and Dr. Ramalingam, Professor of Urology, PSG Institute of Medical Science and Research, Coimbatore, expect the percentage of robot-assisted surgeries to jump to 50% by 2025 from around 10% today. Mr Abhishek Sinha, Chief Operating Officer and Member of the Board at L&T Technology Services said, “Technological disruption is transforming the development process across markets, promoting new levels of efficiency and creativity in manufacture of healthcare products. It is also essential to connect with the leading lights of the academia to further the cause of healthcare to all. LTTS is proud to be a part of the technological shift that is transforming the medical and healthcare landscape.” “Training surgeons to become proficient in the use of robots is a major challenge in India. Innovative low-cost training systems such as the Endo-Training kit and new VR/AR based training simulators such as RoSS promises to address the needs of the fast-growing clinical robotic sector,” said Professor Kesh Kesavadas of the University of Illinois. A few products showcased at the symposium include:  Robotic-Endo Training Kit: A compact, cost-effective surgical robot, for affordable and advanced laparoscopic and endoscopic surgical training, developed in association with KAIST, PSG and assisted by the Global Innovation & Technology Alliance (GITA) Chemistry Analyzer: A fully automated clinical chemistry analyzer, with intelligent multitasking software 3-Part Cell Counter: India’s first indigenously built and cost-effective blood cell counter, developed in association with Agappe Diagnostics Ltd Chest X-Ray: An AI-based image analysis and pneumonia detection solution to help radiologists identify the symptoms and detect the disease in its initial phase ]]> https://biospectrumindia.com/news/97/15789/redefining-cancer-diagnostics-with-digital-pet-ct-scanner.html https://biospectrumindia.com/news/97/15789/redefining-cancer-diagnostics-with-digital-pet-ct-scanner.html Fri, 14 Feb 2020 15:00:00 +0530 HCG – the specialist in cancer care introduces the first Digital PET CT scanner in Karnataka, for high precision diagnosis in cancer and therefore better treatment planning.  Biograph VISION- 600, by Siemens is the first UDR detector with 3.2-mm LSO crystals[a] and helps in visualizing smaller lesions. It improves accuracy, performance, and reproducibility to see a whole new world of precision in PET/CT imaging. The blend of resolution and effective sensitivity assists in evaluating the impact of the treatment in prior. Addressing the press, Dr. KG Kallur, Director - Molecular Imaging, HCG said, “In cancer care, the need of the hour is precision and accuracy and a PET CT scan is crucial for accurate diagnosis of cancer.  With the adaption of Digital PET CT, HCG will now have the advantage to report cancerous lesions or tumors more accurate and fast, eventually plan the treatment better and achieve the desired clinical outcome for a patient. This is possible because of the enhanced imaging technique provided by VISION-600 Digital PETCT, combined with the expertise of the Molecular imaging department, focused to offer superior service to patients for early diagnosis of cancer.” He further added, “In this unit of HCG, we do about 30 to 50 PET CT Scans in a day and the demand is surging with increased awareness on early cancer diagnosis. The waiting time of patients will reduce along with the hazardous risks of radiation for our medical technicians as the amount of isotope usage for the scan, will be reduced by 50% in Digital PET Scan. ” Dr. B.S Ajaikumar, Chairman & CEO, HCG Enterprises Ltd said, “In cancer care, early diagnosis has proven to be the key and treating it the right way the first time with proper staging results in achieving better outcomes. We at HCG, are happy to announce the introduction of Digital PET CT, which transforms diagnosis and therapy to a much higher level. We are able to achieve precision and make disease staging even at the millimeter level and deliver appropriate treatment. This is the highest technology possible globally for image diagnosis. HCG has always invested in the best of technology and expertise for our patients for improved outcomes, testified by Harvard Business Review and the World Bank. This is another milestone for us in achieving our goals towards precision medicine and outcomes on par with global standards.  “We are proud to partner with HCG, who is a renowned cancer care provider in India. With exceptional features such as the market’s fastest time-of-flight and highest effective sensitivity, Biograph Vision™ helps reduce scan time and injected dose, reducing patient exposure to radiation. We look forward to our journey together in transforming care delivery by setting benchmarks for precision in PET/CT imaging.” said, Mr. Vivek Kanade, Executive Director, Siemens Healthineers, India. Advantages of Analog VS Digital PET CT  Analogue PET CT Digital PET CT Slow processing Faster processing and crystal technology Time taken: 15- 20 mins Time taken: 5 mins Precision levels are low Precision levels are very high, crisp and improved image quality Isotope levels are high Isotope levels are reduced by 50-70% ]]> https://biospectrumindia.com/news/97/15769/medical-devices-to-be-treated-as-drugs-from-april-1.html https://biospectrumindia.com/news/97/15769/medical-devices-to-be-treated-as-drugs-from-april-1.html Wed, 12 Feb 2020 14:10:00 +0530 As per the recent notification of Ministry of Health & Family Welfare, all medical devices sold in the country will be treated as drugs and would be regulated under the Drugs and Cosmetics Act of 1940. Currently, only 23 medical devices are regulated under the Drugs and Cosmetics Act The list of such equipment—in all, 37 in number—includes disposable syringes, needles, cardiac stents, catheters, heart valves, X-ray and ultrasound machines. The centre's move to regulate the medical device industry comes as a measure to ensure quality and "safety" for patients, and will come into effect from April 1. The health ministry said the decision was taken after consultation with the Drugs Technical Advisory Board (DTAB), the apex decision making body on technical matters related to drugs. In a separate notification, the health ministry made some amendments to the Medical Devices Rules, 2017. This will be called Medical Devices (Amendment) Rules, 2020 and would also come in force from April 1. It says, “The medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO). Such registration is voluntary for a period of 18 months, after which it will be mandatory. The manufacturer of a medical device shall upload the information relating to that medical device for registration on the “Online System for Medical Devices” established by the CDSCO. Importers too will be required to do the same.” "Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints," the health ministry notification read. It can also cancel the license of a manufacturer if it finds lapses. Further, it gives timelines for registration and regulation of devices. For low and moderate risk devices if is 30 months from date of commencement of the rules, while for moderate high risk and high risk devices it is a period of 42 months within which it would be brought under the new regulations. Rajiv Nath, Forum Coordinator, AiMeD said, “While we manufacturers are ok to be regulated under a Risk Proportionate Medical Devices Rules 2017 we are highly uncomfortable to be regulated under the very rigid and prescriptive Drugs Act as any non-conformity can be treated as a criminal offence by any Drug Inspector at his discretion and hauled before a court and there are no risk proportionate penalties. We have been seeking an assurance from MoH&FW that this is a temporary measure until the NITIAayog drafted Bill to regulate Devices separately from Drugs becomes a separate Law but no meeting has been called by MoH&FW to address these apprehensions.” Pavan Choudary, Chairman and Director General, Medical Technology Association of India (MTaI) said, “We welcome the government’s decision to regulate all devices, which has also been a long standing ask of the industry. These regulations, that are a continuation of the Medical Devices Rules 2017, which were launched after meticulous deliberations for 2 years, are in line with the government’s vision to provide equitable access to quality healthcare. We are also happy that the Health Ministry is recruiting competent resources to cater to the additional workload that these new regulations will bring.” Abby Pratt, Vice President, AdvaMed said, "AdvaMed and its member companies appreciate Indian government’s decision to regulate all medical devices under the guidelines issued by the Ministry of Health as per the Medical Devices Rules 2017 and strengthen regulations to improve safety and quality of products available in India. We believe this decision to make norms more stringent and the MoH’s investment in capacity building by recruitment of specialised auditors will benefit the medical devices industry and the patients at large. We congratulate the Ministry of Health and Family Welfare for its efforts to support Prime Minister Narendra Modi’s ‘Make in India’ initiative by globally harmonising India’s regulatory structure, which will enable domestic manufacturers of medical devices and IVDs to make in India for the world. It will prove pivotal in enabling a more predictable pathway for globally recognised technology to enter India and lessen the gap between India’s access to research-based medical devices and diagnostics.” ]]> https://biospectrumindia.com/news/97/15755/cordis-to-launch-railway-sheathless-access-system-in-india.html https://biospectrumindia.com/news/97/15755/cordis-to-launch-railway-sheathless-access-system-in-india.html Wed, 12 Feb 2020 10:00:00 +0530 Cordis, a Cardinal Health company will begin marketing the technologically advanced Railway Sheathless Access System in India this year. Cordis’ Railway System is indicated for use in radial artery procedures requiring percutaneous introduction of intravascular devices. A percutaneous procedure is a method that allows doctors to insert a medical device into a patient's blood vessel by using a needle, a guidewire, an introducer sheath and a catheter. The catheter is used to deliver medication or implant a stent into the blood vessel. The innovative Railway System is designed to enable direct access to the radial artery in the wrist with a guiding catheter without the use of an introducer sheath. This reduces the size of the arterial puncture site by up to 2F compared to a conventional sheath system. The Railway System received the European CE Mark approval in March 2017 and U.S. Food & Drug Administration clearance in April 2018. The Railway System will be available in India later this year. Cardiovascular disease (CVD) is now the leading cause of death in India with one in four people dying because of CVD. Ischemic heart disease and stroke are responsible for more than 80% of CVD deaths in India. The use of percutaneous coronary intervention to treat CVD in India has sharply increased with transradial access for cardiac catheterization and intervention growing steadily over the last 10 years. Transradial cardiac catheterization is a procedure used to treat and diagnose certain heart conditions. This endovascular procedure can access the body’s arterial system from the radial artery in the wrist. Dr Kintur Sanghvi, Associate Medical Director of Interventional Cardiology and Endovascular Medicine at Deborah Heart & Lung Center in Browns Mills, New Jersey, the inventor of the Railway System said, “In our experience the Cordis Railway sheathless access system minimizes the radial artery trauma and disruption, by reducing artery puncture size up to 2F (33%) while allowing larger bore guide catheter use during transradial coronary procedures. In our study the Railway system reduced the incidence of spasms, radial trauma and improved the transradial access success rate for complex coronary procedures. This resulted in reduced vascular complications, leading to early ambulation and discharge from the hospital”. Clara Tan, Cardinal Health’s Managing Director, Emerging Asia said, “Cardinal Health is a leader in the cardiovascular and endovascular spaces. Our goal is to bring the best medical devices to India. We hope that by introducing the Railway system in India we will be able to help improve patient outcomes and provide Indian doctors with better treatment options for people suffering from heart disease”. The Railway System will help to overcome some of the current limitations of transradial access and enable physicians to treat more complex lesions via radial access and expand availability of this minimally invasive, patient friendly transradial approach for more patients.    ]]> https://biospectrumindia.com/news/97/15734/metropolis-unveils-pneumonia-panel-across-india.html https://biospectrumindia.com/news/97/15734/metropolis-unveils-pneumonia-panel-across-india.html Thu, 06 Feb 2020 13:00:00 +0530 With objective to provide quick and accurate tests of pneumonia, Metropolis Healthcare Ltd has announced the launch of its Pneumonia Panel across its labs in India. Lower respiratory tract infections are caused by a variety microorganism such as bacterial, viral fungal organisms. These infections cause high morbidity and mortality in hospitalised patients. Early, rapid and accurate identification of these organisms is crucial towards selection of the appropriate antimicrobial treatment and patient management; however, existing traditional detection methods are slow. Besides, the molecular tests are often either unavailable or are not routinely ordered on the specimens. The Pneumonia Panel of Metropolis Healthcare Ltd will help address these issues. Dr Niranjan Patil, Head, Microbiology, Metropolis Healthcare Ltd said, “Pneumonia patients are frequently over-treated with antibiotics because it is difficult to quickly identify the pathogen responsible for their symptoms. In order to plug this gap, at Metropolis, we have launched Pneumonia Panel. It is equipped to deliver accurate pathogen identification in about two hours.” He added, “Our panel will enable the physicians to put patients on appropriate therapy quickly.” Pneumonia Panel will have potential impact on modifications to antimicrobial therapy for respiratory pathogens in sputum, endotracheal aspirates, broncholoalveolar lavage (BAL), miniBAL specimens. The Pneumonia Panel looks for 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical bacteria), 7 antibiotic resistance genetic markers and 9 viruses that cause pneumonia and other lower respiratory tract infections. For 15 of the 18 bacteria, the Pneumonia Panel provides semi-quantitative results, which may help determine whether an organism is a colonizer or a pathogen. Antimicrobial therapy may be modified basis the results of the panel. As it identifies various genetic markers associated with drug resistance, it greatly helps to modify treatment plans at the earliest and provide clinicians with vital information to deal with difficult to treat drug-resistant bacteria. As compared to conventional methods, use of the lower respiratory Pneumonia Panel might lead to increased rates of antimicrobial therapy optimization with low risk for inappropriate therapy at very faster turnaround times.   ]]> https://biospectrumindia.com/news/97/15729/cancer-detection-now-possible-with-a-simple-blood-test.html https://biospectrumindia.com/news/97/15729/cancer-detection-now-possible-with-a-simple-blood-test.html Thu, 06 Feb 2020 10:30:00 +0530 A new study by scientists from India, USA, and UK has presented clinical evidence for an innovative test that can detect clusters of cancer cells in the blood of asymptomatic individuals as a non-invasive screening and diagnostic test. The test could make cancer screening easier, efficient and affordable, and can potentially be a breakthrough in cancer detection and diagnosis. The test will soon be available commercially. Commenting on the study, principal author Dr. Dadasaheb Akolkar, who is the Research Director at Datar Cancer Genetics, said, "This is the first study of its kind to investigate the prevalence of circulating tumor emboli or C-ETACs (Circulating Ensembles of Tumor Associated Cells), in a population size cohort of over 16,000 participants, to establish a definitive new systemic hallmark of cancer. The technique we have used is a breakthrough innovation. When clusters of cells break off from an early stage tumor and enter the bloodstream we can efficiently and accurately isolate a few hundred malignant cells from more than 100 million cells, from just 10 ml of blood. While almost all the cancer samples had these cell clusters, they were seen in very few of the samples which were apparently without cancer." Speaking on the breakthrough study and technique, Mr. Rajan Datar, Chairman and Managing Director, Datar Cancer Genetics, said, "Cancer is rapidly becoming a civilizational challenge. Importantly, cancer deaths are mainly due to late detection. We believe that this innovative blood based test is a breakthrough in cancer screening and will impact outcomes by easy, patient-friendly detection and diagnosis in apparently healthy people who may have a silent malignancy in their bodies! It has the potential to eliminate the need for invasive biopsies and the risks associated with it. In the near future, a simple, inexpensive blood test that could be all that is required to reliably detect and diagnose cancer, even before any symptoms are seen." The study involved 16,134 participants, including 5,509 patients with cancer (TrueBlood study) and 10,625 individuals with no symptoms (RESOLUTE study) and the test has shown an accuracy of more than 94%. The C-ETACs were seen in 89.8% of cancer cases and in only 3% of apparently healthy, asymptomatic individuals who had no abnormal findings in presently used screening tests. The study was the largest of its kind in the world. Datar Cancer Genetics also presented further data at several leading international conferences including AACR, ASCO and ESMO Early detection of cancer is crucial but challenging, because of the lack of efficient and reliable screening methods. Most of the commercially available cancer-screening tests are invasive and expensive. Also, currently available cancer screening techniques such as mammograms and low-dose CT scans (LDCT) carry radiation risks, colonoscopies are invasive, blood based markers are non-specific and tissue biopsies for diagnosis have the same risks as general surgical procedures. ]]> https://biospectrumindia.com/news/97/15718/with-an-additional-5-health-cess-in-play-patients-take-the-hit.html https://biospectrumindia.com/news/97/15718/with-an-additional-5-health-cess-in-play-patients-take-the-hit.html Wed, 05 Feb 2020 06:00:00 +0530 The Union Finance Minister, Nirmala Sitharaman, in the 2020-21 Budget statement announced an additional 5 percent health cess on imports of medical devices. In the current scenario, India imports over 70 percent of its medical devices with a fourth of them from the US. Medical device imports rose by 24 percent in 2018-19. Although the intention to impose a 5% health cess was to boost the growth of domestic industry and generate resource for health services, the global research-based industry representatives expressed their disappointment on the same. Till date, the customs duty was 7.5 % + educational cess. With an additional 5% health cess, the new customs duty becomes 12.5 % + educational cess. Deliberating on the increased cost, industry experts believe that the budget failed to project India as a robust and stable market to help it rise to the top. It becomes crucial to understand how a major chunk of expenditure for initiatives such as improving health infrastructure would come out of levy of duty (in form of Health Cess @ of 5% ad valorem) on import of critical medical devices. Additionally, a Social Welfare Surcharge @ 10% on import of certain medical equipment has been proposed. However, the proposed mechanism will only increase the costs for the consumers- patients, thereby going against the moto of healthcare affordability. For a country that relies heavily on imports to meet its domestic needs, an additional tax will not only dent the influx of advanced medical equipment coming to Indian shores but will also have patients bear the brunt. In 2019, the National Health Accounts (NHA) released a report citing, “patients bear a big chunk of health expenses — as high as 61 percent of the total health expenditure — by themselves.” According to the WHO’s health financing profile for 2017, more than 65% of healthcare spend was paid out of pocket (by the patients) in comparison to the world’s average of 18.2%. Highlighting on the impact of the proposed health cess, Abby Pratt, Vice President, AdvaMed, stated, “Global manufacturers of medical devices and diagnostics, represented by the Advanced Medical Technology Association (AdvaMed), are focused on ensuring access to medical technology innovations that save and improve patients’ lives. We are concerned about consideration of policies, such as a new health cess on imported medical devices in India, that could have unintended, adverse consequences, including limiting patient access to appropriate medical technology treatments and cures available in other countries, and ultimately increased – not decreased – health care costs. AdvaMed is committed to working with policymakers and other health care stakeholders in India and elsewhere to pursue solutions to health policy challenges that put patients first, and that help increase -- not decrease -- access to appropriate, affordable treatment and care. We believe a stable and predictable market environment is key to driving future investments in R&D, manufacturing, and other services to grow the medical technology industry in India and meet the current and future needs of all of India’s people”. The proposed health cess might hamper progressive healthcare policies, with patients bearing the additional cost. In light of the same, Meenakshi Nevatia, Managing Director, Stryker India Pvt, stated, “Stryker welcomes the government's steps towards making healthcare more accessible to Indians and efforts being taken to strengthen the sector. We appreciate the increase in investments in healthcare particularly in Tier 2 and Tier 3 towns where the need is greatest. However, we feel the budget proposal to impose a health cess on the imported medical devices is a worrisome move and is contrary to government’s vision to provide affordable healthcare to Indian patients which depends largely on imported technologies. The removal of duty exemption on critical implants will hugely impact the ability of medical device companies to continue bringing innovative medical implants to India. The move may only hurt the sector which is reeling under price capping on premium devices. Moreover, such steps could impact the investments being made in research and innovation by the global medical devices companies in India”. ]]> https://biospectrumindia.com/news/97/15708/fujifilm-india-expands-footprint-in-bengaluru.html https://biospectrumindia.com/news/97/15708/fujifilm-india-expands-footprint-in-bengaluru.html Tue, 04 Feb 2020 06:50:00 +0530 Fujifilm India Private Limited, a global pioneer in imaging technologies, has announced the opening of its new office in Bengaluru, India. This new set-up will help the company further expand its presence in southern India, better serve its existing customers, and also provide an exciting and fun working environment to its workforce. The new office, located on Infantry Road, comes equipped with best-in-class amenities and service capabilities. Multi-coloured workstations along with Wi-Fi meeting rooms with HDCOM facility, collapsible training rooms. It will also offer endoscopy and DSC camera service centers to serve its ever-increasing customer base in the region. With this, we will able to provide better customer service to our customers in the Bangalore region. With the new workplace, Fujifilm plans to increase the workforce by 30% in the city across functions like Electronic Imaging Division, Instax, Industrial Products and Medical Systems. The Bengaluru team will work closely with the Gurugram head office and other offices in India and around the world to drive value from collaborative innovation. Speaking at the launch of the new Bengaluru set-up, Mr. Haruto Iwata, Managing Director, Fujifilm India Pvt. Ltd., said, “India is the most important market for us in the Asia-Pacific region, and we see huge potential in the country from a market, innovation, and talent point. Our new office is reflection of our commitment and trust in the promise that the country holds. Our vision has always been to provide an open, fair and clear workplace culture that allows individuals to ascertain their objectives sincerely, make rational decisions, and continuously take on challenges with courage. With this new set-up, we are offering a collaborative and efficient workspace that reflects our style of business, boost productivity and helping themselves and firm grow.” Speaking at the launch Mr Navneet Kumar Ahluwalia, Head - Human Resources & Administration, Fujifilm India said, “At Fujifilm India, we ensure that we are equally committed towards our customers and workforce. The new space in Bangalore is an ergonomically designed workspace, with an open and collaborative work environment, and a capacity for different teams to work together, driving synergies and contributing to business outcomes. We are focused on offering a dynamic workplace with immense growth potential to all our employees.” Sharing his views on the new office, Mr Sanjeev Kohli, Project coordinator and Senior Manager, Admin at Fujifilm India said, “The setup of the new office was completed in around 70 days. We have designed this new office keeping in mind the vibrant colours define the setting of a workplace and influence an employee’s mood and the entire office environment. With the Endoscopy and Camera Service centre established in our Bangalore office we want to provide full support to our customers in and around the city of Bangalore” Fujifilm India is currently serving its customers across the country with five offices located in Mumbai, Kolkata, Chennai, Bengaluru and with its head office in Gurugram. The energetic, contemporary and distinctive culture of the new office reflects Fujifilm’s vision and efforts of empowering the local management to bring the best of products and services for our consumers and focus on India as well as a new growth area. ]]> https://biospectrumindia.com/news/97/15704/quest-diagnostics-picks-siemens-for-immunoassay-testing-.html https://biospectrumindia.com/news/97/15704/quest-diagnostics-picks-siemens-for-immunoassay-testing-.html Tue, 04 Feb 2020 06:00:00 +0530 Siemens Healthineers has announced that it was selected by Quest Diagnostics, provider of diagnostic information services, to be its preferred supplier for immunoassay testing. As part of the multi-year agreement, which builds on an existing partnership, upon successful execution of sequenced phases, the partnership foresees Quest Diagnostics deploying up to 120 Atellica Solution immunoassay analyzers across 19 esoteric and core laboratories throughout the U.S. Additionally, a highly automated Quest lab in Clifton, New Jersey will feature Atellica Solution immunoassay analyzers connected to an Inpeco FlexLabTM automation system for a high-throughput, multidisciplinary testing solution designed to substantially increase productivity, reduce turnaround time, decrease unwanted variations, and lower operational costs. The new flagship lab is expected to be completed in 2021. Deepak Nath, President of Laboratory Diagnostics at Siemens Healthineers said, “Siemens Healthineers offers a comprehensive and quality in vitro diagnostics portfolio that is proving to be attractive to leading laboratory providers across the globe. Our leadership in workflow and automation is resonating with laboratories worldwide and driving adoption of the Atellica Solution. The breadth and depth of our testing solutions—a highly scalable and flexible offering with the Atellica Solution, and a broad immunoassay test menu with proven assay performance, will provide the clinical outcomes Quest Diagnostics requires.” Jim Davis, Executive Vice President, General Diagnostics of Quest Diagnostics said, “Our strategic relationship with Siemens Healthineers led to the development of a flexible solution that will improve our existing workflow and help us achieve greater cost savings. We look forward to implementing this solution throughout our laboratory network.” The Atellica Solution offers a flexible solution and quality clinical capabilities required to serve Quest’s providers and patients. Leveraging the features and broad assay menu the Atellica Solution offers, Quest will be able to increase its immunoassay testing volume and improve turnaround time concurrently. ]]> https://biospectrumindia.com/news/97/15700/dr-trust-launches-hi-tech-weighing-scale-.html https://biospectrumindia.com/news/97/15700/dr-trust-launches-hi-tech-weighing-scale-.html Fri, 31 Jan 2020 17:20:00 +0530 Dr Trust, home health-tech devices has announced the launch of a hi-tech weighing scale which not just gives users a measure of weight but also assesses them on 18 vital health parameters to determine how fit they really are. Drawing on the immense potential of Internet of Things (IoT) and telemedicine, the Dr Trust Bluetooth Body Scale allows users to send readings to their doctors in real time. The device provides an end-to-end monitoring solution from home settings by enabling users to sync the data on 18 critical fitness parameters with Dr Trust Scale Connect App as well as Apple Health and Google Fit. While allowing users to examine the progress on their weight loss efforts, the Dr Trust Bluetooth Body Scale gives a true picture of fitness levels by accurately evaluating crucial factors like body mass index, basal metabolism rate (BMR), body age, bone mass, visceral fat, muscle mass, body fat percentage, skeletal muscle and much more. Maintaining that the importance of these indicators cannot be overemphasised, Saurabh Goyal, Executive Director of Nureca Pvt Ltd, which owns the Dr Trust brand, said that while a high BMI can be an indicator of high body fatness, excess visceral fat can also have potentially dangerous consequences by inviting the risk of Type 2 diabetes and heart disease. “Stored in the abdominal cavity close to vital organs like pancreas and liver, visceral fat influences the functioning of hormones. On the other hand, an accurate assessment of BMR, the number of calories the body needs to perform the most basic life-sustaining functions, can help gain, lose or maintain weight, as the case may be. By knowing how many calories you burn, you can know how many to consume,” he said. Goyal said the capability of the device to keep track of low bone mass can help users prevent debilitating conditions like osteoporosis by including bone-strengthening nutrients in their diet. “Yet another useful feature of Dr Trust Bluetooth Body Scale is its ability to determine your body age, a measure of how old you are biologically based on health and fitness levels. So, for a person aged 30 whose body age turns out to be 40, this revelation can act as a big motivation to work towards improving overall fitness levels,” he added. The device not just enables users to map recent data against previous readings to track fitness levels, it can also sync the data of eight users with date and time. "Portable, rechargeable and easy to use, the Dr Trust Bluetooth Body Scale can be an ideal companion for gym goers,” said Goyal. Powered by the patented Accu Gauge technology, the USFDA, CE and ISO-approved Dr Trust Bluetooth Body Scale with 10 registered design patents has four high-precision gauge sensors which bring down deviation in weight measurement to 50 grams as against the market range of 100-200g. It delivers a two-decimal point precision in readings, thus providing the most accurate results.     ]]> https://biospectrumindia.com/news/97/15698/a-winning-situation-from-us-india-trade-deal.html https://biospectrumindia.com/news/97/15698/a-winning-situation-from-us-india-trade-deal.html Fri, 31 Jan 2020 14:00:00 +0530 Amid the ongoing positive developments in the India-US trade deal, speculations to replace the practice of blanket price caps for high-end medical devices and opt for Trade Margin Rationalisation have surfaced online. If media reports are to be believed, there has been substantial progress on the trade negotiations with a win-win situation for both the countries. This comes as a relief for healthcare professionals who have always vouched for the quality and innovation of medical devices as both suffered a backlash due to price control. With focus on innovation resulting in better clinical outcomes, through this deal, the government is enabling an innovation-friendly and sustainable environment to ensure access to affordable and quality healthcare. Many healthcare experts are of the opinion that Trade Margin Rationalisation lays the roadmap to create a robust healthcare ecosystem ensuring patient safety and promoting innovation. Many believe that this is a step in the right direction and will lead to the revolution in the medical devices industry (safeguarding safety is more of a regulatory function performed by the Health Ministry before a product reaches the market). The trade deal once finalised will be a huge contributor towards reforms in the medical devices industry by ending downstream mark-ups and other unethical business practices. By using landing price as the base for trade margins there will be more transparency in the pricing of the technology and would usher in more market stability through enhanced predictability, making India a more attractive and stable market once a clear and consistent pricing mechanism is brought in by the government. It help both Indian and global manufacturers get level-playing field thus, resulting in the overall growth of the economy. Considering the on-going developments, ‘Indo-US trade deal’ will also help resolve the pre-existing glitches and differences over price capping. Rationalising the trade margin of medical devices will not only allow to bring in affordability but also accessibility to latest technology and paving way for premium devices into the Indian market which had been blocked “The recent development in the India-US trade deal would act as a catalyst for foreign direct investment in India. It will also create an enabling environment for global medical device and diagnostics industry to promote their innovative and technologically advanced products in India, undoubtedly with focus on patient safety. This deal brings us closer to an innovation equilibrium between the current and future needs of Indian citizens. It will help to overcome challenges in providing access to innovation, quality and affordable healthcare in the country based on current discoveries, an opportunity to increase investment in research and development. To sustain this equilibrium, let’s ensure to preserve the incentives to innovate. Continuous deliberation between experts from medical device industry and government on price control, led to the recognition of the term – Trade Margin Rationalization (TMR) which is nothing but the difference between maximum retail price and the price at which the manufacturers sell the drugs to stockiest /distributors,” said Dr. Gajendra Singh, Public Health Expert. The significance of trade relations between both the countries can be adjudged from the fact that the US was the second-largest trading partner for India in goods in 2018 and the single largest export destination for Indian exporters. The bilateral trade between both the countries reached $142.1 billion by 2018 when the US had the trade deficit of $24.2 billion with respect to India. As per the National Trade Estimate Report on Foreign Trade Barriers 2019, India’s tariff rates on other members of the WTO remain the highest of any major economy. Dr. Amir Ullah Khan, Development Economist, stated, “With the ongoing US-India trade deal and the combined efforts of PM Modi and Trump, a balanced policy approach seems to be the only solution for the two nations, with focus on quality treatment and patient safety. The government of India should adopt a holistic TMR approach toward improving the overall health infrastructure and not just follow a narrow approach when calculating margins. Considering the difference between manufacturing cost and the retail price, the price capping mechanisms have been regularly hitting the pharmaceutical and medical devices industry. A country that meets 80% of its demand for medical devices through imports cannot suddenly disregard the innovative capabilities of the imported technology over cost.” The nuances of medical device industry— innovation, transparency, quality, the clinical and technical support of the manufacturers, accounting for massive investments cannot be outrightly ignored. Only a robust and balanced TMR will address the hardships of end-users, address the commercial and industrial concerns of hospitals and providers, be remunerative to vendors and help the government in its quest for universal healthcare for all at affordable prices. TMR is undoubtedly a win-win solution. ]]> https://biospectrumindia.com/news/97/15667/edan-launches-intelligent-diagnostic-solutions.html https://biospectrumindia.com/news/97/15667/edan-launches-intelligent-diagnostic-solutions.html Wed, 29 Jan 2020 11:15:00 +0530 New Delhi based EDAN Instruments unveiled its next-generation diagnostic ultrasound system Acclarix LX9 at Arab Health 2020, the largest healthcare exhibition in the Middle East, making EDAN a headliner among the exhibitors in the Imaging & Diagnostic sector. Aiming at satisfying the clients' needs in every perspective, EDAN keeps elevating its products from the aspect of ergonomics, human-machine interface, and practicability. "Acclarix LX9 is ushering EDAN's ultrasound imaging into the age of intelligent diagnosis. With the new added advanced features like eOB, eLV, eFollicle, eVolFlow, and eNT, LX9 provides a smart workflow solution, which optimizes the workload of sonographers across multiple departments, including obstetrics, gynecology, cardiology, and general surgery, etc.," said Alice Bai, EDAN's ultrasound clinical application manager. Apart from the workflow, LX9's image quality also shimmers. The brand new EIS+ platform presents rich details on a 21.5-inch high-resolution LCD screen for sonographers to take a better look at patients. LX9's slim body and 180-degree rotatable integrated user interface attracted a crowd in front of EDAN's booth S1.L19. EDAN's CTG monitor F15 was equally desired at Arab Health this year. As EDAN's revolutionary generation products in obstetrics, F15 brings EDAN's obstetrics products into a whole new level, visual-wise and technology-wise. The device supports triplet monitoring, and its wireless TOCO transducer can provide maternal heart rate (MHR) simply by plugging on a cover on top. Its "Transfer" function and the 15-minute resume breakpoint function enable the device can be used smoothly during interhospital transfer. ]]> https://biospectrumindia.com/news/97/15664/trivitron-launches-advanced-critical-care-solutions.html https://biospectrumindia.com/news/97/15664/trivitron-launches-advanced-critical-care-solutions.html Wed, 29 Jan 2020 06:00:00 +0530 Trivitron Healthcare launches 10 new innovation-driven products in Advanced Imaging modalities and Critical Care & Life Support segment, at Arab Health 2020 conference in Dubai. The new products launched include Elite – Flat Panel Digital C-arm with motorized movements, SonoRad V10 – Color Doppler Ultrasound System, Breast Imaging solutions, Ventilators, Dialysis systems & consumables, Modular OT solutions, Monitors, ECG, Syringe pumps and Anesthesia systems. Kiran Medical Systems, the radiology division of Trivitron Healthcare, has been a frontrunner in research and development of advanced imaging modalities and with the launch of Elite –Flat Panel Digital C-arm with motorized movements & SonoRad V10 Ultrasound, the imaging portfolio of Kiran is furthermore enhanced suiting different global imaging market needs. With recent developments in the field of Artificial Intelligence and Digitization in healthcare, Trivitron launches Digital OR integration with seamless connectivity with all Imaging data and Modalities to the surgeons in the OR with all modalities under one roof. With the launch of Trivtron’s State of the art Dialysis machines & Ventilators, with lowest life cycle and running cost brings unique value proposition and comprehensive package thereby only company providing complete Solutions in Critical care life support systems. Trivitron is committed to quality healthcare delivery in the countries in the Middle East and Africa through its subsidiaries Trivitron Healthcare Middle East and Trivitron Healthcare Africa. In addition to the entire Kiran imaging portfolio, the subsidiaries provide end to end turnkey solutions by bringing in world-class OT, ICU, Renal Care products. Trivitron’s Kiran Elite C-Arm features high-resolution digital image acquisition with 1K X 1K Flat Panel Detector and 16-bit image processing. With World-Class 5 kW, 40 kHz X-Ray Generator with ABS for optimized dose, Elite delivers superior images with the higher grayscale resolution to view remarkably minute details and improves the workflow in a significant way with completely motorized & smooth movements that aid in accurate positioning. With a Touch Panel User interface on the C-Arm, choosing the parameters becomes comfortable and efficient. Elite offers Clinical features like DSA - Digital Subtraction Angiography for Vascular applications and Road Mapping that allow surgeons to find the path to reach the target location in branches during the surgery. The Model comes with User-friendly Workstation and a storage capacity of more than 100,000 images and offers extra power for complex cases and active cooling to prevent overheating during long procedures. Elite has wide clinical applications in Cardiovascular, Interventional Radiology, Orthopedics and Urology. With a focus on offering comprehensive imaging solutions to customers, Trivitron’s Kiran has launched its 2nd model in Ultrasound -SonoRad V10 Whole Body Color Doppler, an ergonomically designed Color Doppler with Dual Image Display – on the 19” HD LED Monitor with larger image area, as well as the 10.1 touch panel which makes the workflow easier. It features intelligent software for efficient and precise measurements in OB. Quantitative Elastography, Panoramic Imaging, 4D features like Depth View & Virtual HD, 210 O Wide-angle TV Probe etc deliver Superior Clinical Value. SonoRad V10 supports a wide range of Clinical applications like Obstetrics/ Gynecology, Radiology, Cardiology etc with high performance. Kiran’s portfolio of radiology products includes the Felicia Digital Mammography, Ultisys range of Mobile & Fixed Radiography systems with the option of digital image acquisition chain, Infinity and Elite series surgical C-Arm systems available in 3.5kW and 5.0kW generator power options, Premium Digital Radiography solution, a comprehensive range of Radiation Protection Products, Anti-scatter X-ray grids and a wide range of Imaging Accessories & Consumables. The manufacturing facilities of Kiran comply with the most stringent quality standards and are registered with US-FDA, SGS-UK, Health Canada and PMDA-Japan amongst others. Speaking on the occasion Mr Satyaki Banerjee, CEO- Medical Imaging Division, Trivitron Healthcare commented, “Kiran is committed to the field of Medical Imaging and has been offering Research Oriented World Class products for 4 decades. The Launch of Elite – Motorized Digital C-arm and SonoRad V10 Color Doppler are in line with our plan to offer incremental as well as a breakthrough innovation in Advanced Imaging modalities that will significantly impact care-delivery. Kiran is also focusing in a major way to create Products and applications with the Power of Artificial Intelligence and Deep Learning. We foresee a paradigm shift in the way overall patient care will be delivered and in 2020 Kiran is preparing itself for exciting launches in Radiology and Imaging with these advanced technologies” Commenting on this development Dr GSK Velu, Chairman and Managing Director, Trivitron Group of Companies said, “Trivitron Healthcare is driven by innovations in Med-Tech to make Healthcare Affordable and  Accessible to everyone across the Globe. We consider quality healthcare a fundamental right of people and envisage making top-notch, cutting edge healthcare technology available for people of all classes. With the launch of new advanced imaging and critical care & OT products, we are one more step closer to our plan to offer a full suite of Radiology, Imaging & Critical Care Products in the next couple of years. With the global distribution strength of Trivitron Healthcare Group, I am confident that these new launches will truly bring a difference in Healthcare delivery across the World” ]]> https://biospectrumindia.com/news/97/15647/siemens-healthineers-launches-acuson-redwood-ultrasound-system-.html https://biospectrumindia.com/news/97/15647/siemens-healthineers-launches-acuson-redwood-ultrasound-system-.html Mon, 27 Jan 2020 12:15:00 +0530 At the 73rd Annual Conference of Indian Radiological & Imaging Association (IRIA) 2020, Gandhinagar, Siemens Healthineers launched the ACUSON Redwood Ultrasound System. The system is built on the company’s new platform architecture and features advanced applications for greater clinical confidence, AI-powered tools for smart workflows and has shared services cardiology features used by different hospital departments. These features, along with a portable and lightweight design, offer clinicians an affordable and efficient high-performing imaging solution. Vivek Kanade, Executive Director, Siemens Healthineers India said, “We are seeing an increased demand for premium medical imaging services being driven by the growing healthcare needs of a population with varied requirements, particularly in regard to chronic diseases,” says Vivek Kanade, Executive Director, Siemens Healthineers India. We worked together with inputs from users to transform care delivery with the ACUSON Redwood and meet these challenges. This system is designed to deliver premium image quality, exceptional performance, and greater workflow efficiency.” As per the company statement, “The ACUSON Redwood’s advanced applications, including Contrast Enhanced Ultrasound (CEUS) and Shear wave Elastography, are available for the first time from the company in this segment and support precise lesion detection and characterization as well as potentially reduces the need for invasive procedures. A full portfolio of high-performance transducers including compact micro-pin less technology and single crystal transducers support superb image quality. With our coherent image formation (CIF) technology, the ACUSON Redwood maintains B-mode image quality performance even in complex modes and the system’s UltraArt Universal Image Processing provides several image choices right on the touch screen avoiding manual adjustment of multiple image parameters. With a suite of AI-powered tools, the ACUSON Redwood delivers smart workflows for greater efficiency. Designed to go beyond the radiology department and bring precision imaging to more patients, lightweight and portable with 13 transducers, the ACUSON Redwood is easy to move and delivers premium imaging capabilities to the various clinical departments within an organization, such as radiology, cardiology and OB/Gyn.” “The ACUSON Redwood is a comprehensive shared services cardiac solution. In this environment it is crucial to address the needs of a broad range of cardiac assessments which is why the system includes applications such as syngo Velocity Vector Imaging (VVI) technology, an advanced 2D quantitative tool for assessment of global and regional myocardial motion and mechanics, stress echo with a complete wall motion scoring analysis package and Left Ventricular Opacification (LVO) mode to enable cardiac contrast agent imaging.” With the ACUSON Redwood, Siemens Healthineers enhances its portfolio of systems built on the new architecture platform, joining the flagship ACUSON Sequoia, and the high-performance ACUSON Juniper. The ACUSON Redwood has 510K clearance from the U.S. Food and Drug Administration (FDA) and European CE mark.   ]]> https://biospectrumindia.com/news/97/15643/lifecell-launches-genome-scope-for-newborn-genetic-testing.html https://biospectrumindia.com/news/97/15643/lifecell-launches-genome-scope-for-newborn-genetic-testing.html Mon, 27 Jan 2020 11:10:00 +0530 LifeCell International, India's premier stem cell bank and Diagnostics Company, has announced the introduction of 'Genome-Scope' - a premier Genetic Diagnostic Test for newborns which assesses for thousands of early childhood-onset disorders. Notably, LifeCell offers this service within a turnaround time of just 10 days, which is twice as fast compared to nearest offering - a vital time reduction for those who seek urgent diagnosis such as babies in the NICU.   With over 7000 rare disorders identified so far, it's vastly difficult for doctors to diagnose the same with traditional diagnostic techniques. A recent study showcased that it takes more than 7 physicians & 4 years to diagnose such rare disorders. Misdiagnosis, hidden symptoms & lack of awareness, are the core reasons for the long diagnostic journey of children with genetic disorders.  With >80% of them being genetic in nature, the recent emergence of low-cost genome sequencing it's now possible to detect relevant causative mutations of almost all of these conditions within a single test, thus far exceeding the routine newborn screening tests currently being offered which cover at most 50 conditions.  LifeCell has introduced this test under the brand 'Genome-Scope'. This breakthrough test uses advanced next-gen DNA sequencing technology to assess over 4000 genes related to early childhood-onset disorders, to provide results with >95% accuracy within just 10 days. Thus, it has the potential to not only expedite the diagnostic journey but also, to save lives. While not all conditions detected may have treatment, the parents may seek such information as it may help prepare for the care of the baby and also in future family planning.  Genome-Scope is also available for well-born kids to identify predisposition to genetic conditions that if detected late could cause irreparable harm. It also provides information on how & which medications the child would respond to, thus providing an impetus to the practice of personalised medicine. Genome-Scope will serve as a particularly important tool for those parents with a family history of a genetic disease or those who have previously lost a child to one. However there is also data suggesting that 80% of babies with genetic diseases are born to parents with no family history or symptoms implying the importance of this test to all families. The test is conducted through a simple process on the cord blood obtained from the baby right after birth for the extraction & preservation of umbilical cord blood stem cells. Alternatively the test could also be done with blood samples obtained from the child after birth through heel prick. The test results are shared with the physician within 10 business days for their reference. Lifecell's in-house certified genetic counsellors would assist the clients in pre and post test counselling. The raw data is also stored with LifeCell for future re-analysis in case there are any changes in the clinical status of the baby.  ]]> https://biospectrumindia.com/news/97/15629/fujifilm-showcases-latest-collection-at-iria-conference.html https://biospectrumindia.com/news/97/15629/fujifilm-showcases-latest-collection-at-iria-conference.html Thu, 23 Jan 2020 18:00:00 +0530 Fujifilm India Private Limited, one of the leaders in Healthcare industry, have displayed its latest medical systems at the 73rd National Conference of the Indian Radiological and Imaging Association (IRIA). The three-day long conference is scheduled from 23rd – 26th January 2020 at MMCC, Gandhinagar, Ahmedabad, India. As part of the event, Fujifilm will be displaying its latest medical devices like FDR - Smart F, FDR - D-EVO II, FDR - SE Lite, FCR - Prima T, Full Field Digital Mammography (FFDM) - Amulet Innovality and Synapse PACS. In DR systems, the company is displaying the FDR Smart F – Fujifilm’s latest high quality, cost effective digital X-ray system that can be easily installed in limited spaces and is easy to use. This product was especially designed for emerging countries like India. Whereas in the FDR D-EVO series, the company will be showcasing FDR - D-EVO II detector that allows smart image processing and dose efficiency for the patients. Fujifilm will also preview the FDR SE Lite retrofit DR detector at the annual meeting. The detector is geared towards bringing DR technology to specialty and small medical practices. In CR systems, Fujifilm will be displaying the Prima TM – an affordable High-speed image processing tabletop FCR (Fuji Computed Radiography) with mammography compatibility. The machine supports a space saving design and provides superior image quality of 50 Micron resolutions. In Medical Informatics, the company will showcase the SYNAPSE-PACS, RIS and Mobility Solution to provide improved workflow, efficiency and quality of reporting in radiology departments. Since 1999, Synapse® has been transforming healthcare organizations with continuous innovation in diagnostic image management, advanced visualization, enterprise imaging workflow and shared informatics architecture. In the Ultrasound space, Fujifilm will display the SonoSite X-Porte FC-I – an ultrasound machine with breakthrough extreme definition imaging for pinpoint precision. It comes with educational resources such as step-by-step tutorials viewable simultaneously with live scans. Also on display will be the newly launched Visionary DX – BMD, Newtom – CBCT and X-Air (Hand-held Portable X-ray system). Commenting on the association with IRIA 2020, Haruto Iwata, Managing Director, Fujifilm India Pvt. Ltd. said, “Today’s healthcare enterprises are entirely focused on improving the quality of healthcare and we at Fujifilm are principally committed at bringing advanced imaging strategies keeping in mind the industry needs. With increasing digitalization and use of AI in healthcare, we aim to provide our users high value care with the cutting edge technologies. As trailblazers in healthcare sector, we are proud to showcase our wide range of medical systems at the 73rd National Conference of the Indian Radiological and Imaging Association. We have designed these technologies to offer comfortable, efficient procedures and help clinicians deliver the best possible patient outcomes.” “At Fujifilm, our key focus areas are Early Detection of Breast Cancer, End T.B Program, Early Detection of lung cancer and colon cancer through state-of-the-art products likes Full Field Digital Mammography, FCR & FDR Systems, Endoscopy Systems. We are even focused on digitization Tele radiology and AI for faster and quality diagnosis of Breast Cancer, Tuberculosis and Lung Cancer. With such associations, we will continue to innovate and provide high quality medical solutions that contribute to better healthcare facilities and services in India.” added Chandrasekhar Sibal, Senior Vice President - Medical Division, Fujifilm India Pvt. Ltd The company will also announce the launch of two books at the conference i.e. Full Field Digital Mammography - CEDM written by Dr Rashmi Sudhir from Indo American Cancer Hospital, Hyderabad and FDR - "Digital Radiography the Power of Imaging" (A book on case done by our users on our DR systems). The books highlight the emerging technology in diagnosis and management of breast cancer. It further highlights unique technologies by Fujifilm that offer solutions to support these diagnosis at an early stage.     Photo Caption- Left to right: Chandrasekhar Sibal, Senior Vice President - Medical Division, Fujifilm India Pvt. Ltd, Haruto Iwata, Managing Director, Fujifilm India Pvt. Ltd, Dr Rashmi Sudhir from Indo American Cancer Hospital, Hyderabad and Fujifilm delegate. ]]> https://biospectrumindia.com/news/97/15580/who-endorses-indian-molecular-assay-for-initial-tb-detection.html https://biospectrumindia.com/news/97/15580/who-endorses-indian-molecular-assay-for-initial-tb-detection.html Mon, 20 Jan 2020 06:30:00 +0530 In a significant development, WHO Global TB Programme has included an Indian Molecular assay TrueNat as initial test for TB and MDR-TB in view of its high diagnostic accuracy, in the rapid communication document on Molecular assays released by WHO’s Global TB Programme. The TrueNat TB test is a new molecular test that diagnosis TB as well as testing for resistance to the drug rifampicin in about 90 minutes. It is a matter of pride for Indian Council of Medical Research (ICMR), Department of Health Research (DHR) New Delhi as this was a long journey for promoting “Indigenous diagnostic technologies for diagnosis of TB and MDR/XDR–TB” developed by Indian scientists. In an effort that was supported by DHR, Ministry of Health and Family welfare, Govt. of India and DBT, various indigenous technologies developed by Indian scientists/companies for detection of MDR/XDR TB were reviewed. Most promising kits were selected by the ‘Expert Group’ and were subjected to a double blind validation in comparison to standard tests at 4 national reference laboratories of the country.  After a stringent review and a series of validation and subsequent feasibility studies and continuous follow-up, the ‘TrueNat M.TB & Rif’ assay was found to be at par with the internationally recognized molecular assay Gene Xpert in terms of sensitivity and specificity and detection of rifampicin resistance. This was taken up by National TB Elimination Programme after recommendations from ICMR. In a major effort as part of WHO pre-qualification process, ICMR funded Indian centres of the FIND-coordinated multi-central, prospective field evaluation study in four countries (India, Ethiopia, Peru, Papua-New Guinea). Based on the interim analysis of the data, WHO included TrueNat as test to diagnose TB (i.e. replacing sputum smear microscopy) and to sequentially detect rifampicin resistance in view of its high diagnostic accuracy. The study has completed enrolment at all sites and the final analysis would be undertaken soon by FIND, Geneva. The TrueNat assay kit is highly cost effective as compared to GeneXpert and can be used in peripheral centers without an AC lab and runs on battery which can be solar powered. The assay has been developed by Goa based Molbio Diagnostics. “Endorsement of the TrueNat by WHO would enable other low and middle income countries to procure TrueNat for TB and Rifampicin resistance thus supporting TB elimination in developing countries” said Dr. Balram Bhargava, Secretary DHR and DG ICMR.   ]]> https://biospectrumindia.com/news/97/15576/invo-bioscience-signs-jv-agreement-with-medesole-healthcare.html https://biospectrumindia.com/news/97/15576/invo-bioscience-signs-jv-agreement-with-medesole-healthcare.html Fri, 17 Jan 2020 10:00:00 +0530 US based INVO Bioscience, Inc., a medical device company focused on treating infertility with its FDA-cleared INVOcell® product, and Qatar based Medesole, a leading supplier of healthcare products in India and the Middle East, have announced the signing of a joint venture to operate dedicated INVOcell clinics in India.   INVOcell, also known as IVC, is the world's only in vivo Intravaginal Culture System, offering patients diagnosed with infertility an effective solution through a simplified, more natural and less costly process than traditional in-vitro fertilization (IVF). The new joint venture (JV) will operate under the name Medesole INVO Bioscience Private Limited. Under terms of the agreement, INVO Bioscience and Medesole will each own 50% of the joint venture. INVO Bioscience will provide the device, training and general technology support to the joint venture, while Medesole will be responsible for the operations of the INVOcell clinics in India. Both partners will equally invest in start-up and capital expenditures and share in the revenue and profits of the joint venture. The joint venture, Medesole INVO Bioscience Private Limited, has set an initial objective of opening three INVOcell clinics over the next 12 months, with additional clinics planned in subsequent years. Based on the initial first year plan, INVO Bioscience anticipates it will invest approximately $150,000 to $200,000 in the JV. Subsequent investments will be based on JV performance and mutual agreements between INVO Bioscience and Medesole. ]]> https://biospectrumindia.com/news/97/15549/ojas-eye-hospital-uses-zeiss-artevo-800.html https://biospectrumindia.com/news/97/15549/ojas-eye-hospital-uses-zeiss-artevo-800.html Wed, 15 Jan 2020 10:10:00 +0530 Zeiss Artevo 8000 is the first and only digital microscope on hand in the market so far. The view is excellent and less taxing compared to optical microscopes. This is the future technology for microscopes and might phase out optical ones. Today, there is no other microscope that possesses similar technology for competition or comparison, so a lot of refinement with the latest choices is expected. This is why Ojas Eye Hospital in Mumbai switched to this kind of technology to further improve their services.The first ever Mumbai's three-dimensional eye surgery and second in the state of Maharashtra was performed on the 11th of January, by Dr. Niteen Dedhia at the renowned Ojas eye hospital, Bandra using state-of-the-art Zeiss Artevo 800, after its installation on 6th January. With this state-of-the-art tool, even the smallest part of the eye is viewed and magnified stereoscopically on the 55-inch high definition 4K screen, offering greater precision as well as accuracy for most excellent visual outcomes. This modern digital microscope is of extremely high power; therefore, a high-intensity light isn't needed compared to other optical microscopes used by other eye clinics. Zeiss Artevo 800 is like a pilot in a digital cockpit allowing real-time data in the doctor's view for utmost detail. This state-of-the-art equipment has 3D technology that allows the radiant digital picture to carry out various surgeries, including cataract surgery, retinal surgery, corneal surgery, Glaucoma surgery through special glasses. This device boasts of superb resolution and remarkable depth of field even with the low light intensity that avoids drying up the eye during surgery. This is possible with a 25% higher resolution of the optics and 25% better light transmission. It makes use of a 2 by 3 chip 4K camera that provides a fantastic stereoscopic vision when working deep inside the eye, like in retinal surgeries. It also enabled cloud connectivity with the Zeiss IOL Master 700 for error fast and error-free lens alignment. It also allows real-time measurement of these pressures during eye surgery. Eye Specialists in Mumbai praised the reliability of this device as it is easy to use compared to the traditional microscope. Also, the incessant strain on the neck and eyes looking into eyepieces is eliminated. With the addition of optical and digital microscopes, this hybrid technology has opened a whole new dimension to ophthalmic surgery. It is the future, and Ojas is proud to be a pioneer in acquiring it. According to Dr. Dedhia, "The integration of this new equipment helps us to make the process of eye surgery faster and successful. The fact that it is high-tech, we are in the position of providing the best service our patients deserve".   ]]> https://biospectrumindia.com/news/97/15543/roche-illumina-to-broaden-ngs-adoption-in-cancer-care.html https://biospectrumindia.com/news/97/15543/roche-illumina-to-broaden-ngs-adoption-in-cancer-care.html Tue, 14 Jan 2020 11:30:00 +0530 Roche has entered into a 15-year, non-exclusive partnership with Illumina to broaden the adoption of distributable next-generation sequencing (NGS) based testing in oncology. As the understanding of the genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring. This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic (IVD) tests on Illumina’s NextSeq™ 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay TruSight Oncology 500 (TSO 500) with new companion diagnostic (CDx) claims. The financial terms of the deal were not disclosed. Under the IVD terms of the agreement, Roche will develop, manufacture and commercialise AVENIO IVD tests for both tissue and blood for use on Illumina’s NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Roche and Illumina will develop and pursue CDx claims on TSO 500 for both existing and pipeline Roche oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process and will continue to manufacture, supply and commercialise TSO 500. Roche will support the development of the claims and regulatory filings. “As a leader in diagnostic innovation that helps save and improve lives, Roche is pleased to enter into a collaboration agreement with Illumina to leverage our combined expertise in clinical oncology and next-generation sequencing,” said Thomas Schinecker, CEO of Roche Diagnostics. “This collaboration is uniquely positioned to improve medical value and clinical decision making globally by combining the unique capabilities of the Roche Group including Foundation Medicine with Illumina and will provide more patients with access to NGS to characterise their disease and identify the right treatment for them. This builds upon our strategy of accelerating clinical research, streamlining workflows and expanding assay menus to broaden access to genomic data and lower barriers to routine use.” ]]> https://biospectrumindia.com/news/97/15501/fda-approves-less-invasive-surgical-approach-for-abbotts-heart-pump.html https://biospectrumindia.com/news/97/15501/fda-approves-less-invasive-surgical-approach-for-abbotts-heart-pump.html Wed, 08 Jan 2020 16:00:00 +0530 Abbott has announced U.S. Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery. The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3™ Left Ventricular Assist Device (LVAD), the industry's leading heart pump. Approximately 615,000 people in the U.S. are living with heart failure and nearly 40% are considered to have reached an advanced stage where traditional therapies no longer work. Heart pumps are small, implantable mechanical devices that pump blood through the body in people whose heart is too weak to do so on its own. People living with a heart pump may be waiting for a heart transplant or may not be candidates for a transplant and will live with the device for the rest of their life. Historically, heart pumps have been implanted via open heart surgery. With approval for an alternative surgical technique, Abbott's HeartMate 3 heart pump can now be implanted via lateral thoracotomy – a surgical approach where an incision is made between a patient's ribs to access the heart. Physicians believe that for many patients this technique has advantages over open heart surgery because it can result in less bleeding and a shorter recovery time for patients. "This is a significant advancement for patients who can now receive a life-saving LVAD through an alternative procedure that can yield shorter hospital stays and a faster recovery," said heart transplant surgeon Igor Gosev, M.D., University of Rochester Medical Center in Rochester, New York. "Heart failure is a crippling and costly disease so being able to offer patients the HeartMate 3 heart pump with this less-invasive approach gives them the opportunity to return to a better quality of life more quickly." The approval is based on two studies – the ELEVATE study: a multi-center, voluntary, observational registry collecting post-marketing data, and the LAT Feasibility study: a single arm, prospective, multicenter study. Results of the two trials found that bleeding (requiring surgery), infection and arrhythmias were lower in the group implanted via the less-invasive surgical approach than those who underwent open heart surgery. "We continue to focus on advancing our heart failure devices and techniques to make life better for the patients we serve," said Robert L. Kormos, M.D., medical director for mechanical circulatory support at Abbott. "The first approved LVAD—HeartMate I—was approved more than 25 years ago. Since that time, the technology has evolved immensely. Today's HeartMate 3 device, including its design and size, allows physicians to successfully implant it without having to perform open heart surgery and offers survival rates, as demonstrated in the MOMENTUM 3 clinical trial, at two-years that are comparable to heart transplants." The HeartMate 3 received approval from the FDA in 2017 for patients with advanced heart failure whose hearts are unable to circulate blood through the body, and are waiting for a transplant, known as bridge to transplant. In 2018, HeartMate 3 was approved as a destination therapy for those individuals who are in need of a new heart but are not eligible for a transplant. ]]> https://biospectrumindia.com/news/97/15423/siemens-healthineers-ships-first-made-in-india-ct-scanner.html https://biospectrumindia.com/news/97/15423/siemens-healthineers-ships-first-made-in-india-ct-scanner.html Fri, 27 Dec 2019 10:05:00 +0530 Siemens Healthineers has shipped its first “Made in India” CT scanner from its new state-of-the-art medical imaging factory in Bengaluru, inaugurated on September 19, 2019. The Somatom go.platform with the Somatom go.Now and Somatom go.Up scanners offers unique automated workflows that help users achieve profound clinical results. Manufacturing of the scanners has already started at the recently inaugurated Siemens Healthineers manufacturing facility in Bengaluru. The factory achieved a key milestone as it recently shipped the first ‘Made in India’ CT scanner (Somatom go.Up), expanding the manufacturing reach in India. “With 350+ Somatom go. platform installations across the country, this manufacturing facility further strengthens our commitment to India. Somatom go. platform CT scanners will help our customers expand their radiological portfolio, become more competitive and achieve consistent, user-independent quality”, said Suraj Chandrasekharan, Head of Diagnostic Imaging, Siemens Healthineers, India. The Somatom go. platform has an innovative way of fulfilling its customers’ desire for efficient workflows and a high level of flexibility: It can be controlled via wireless tablet, a technology which paves the way for an entirely new mobile workflow. Users can control all routine and advanced examinations using just the tablet. The standardized work steps are designed so that the users can run the scan with just a few inputs. Automated post-processing makes it even easier to operate the scanners. The standardization also gives radiologists additional assurance with regards to the diagnostic quality of the images. Vivek Kanade, Executive Director, Siemens Healthineers India said, “Co-created in collaboration with the users to address their needs, the Somatom go. platform offers high quality standards and addresses the ever-increasing needs of workflow efficiency, clinical and financial requirements; enabling them to improve patient experience.” Technological advances are driving transformation in the healthcare industry. As a part of the long-term strategy for India, Siemens Healthineers has integrated manufacturing, technology and innovation functions at Bengaluru with the state-of-the-art Technology and Innovation Centre to better leverage synergies while developing offerings aligned to the future needs of our customers. The ISO13485 (2016) certified manufacturing facility at Bengaluru caters products across Advanced Therapies, Computed Tomography and X-ray systems; aiming to offer unique combinations of technology, software and clinical applications, to enable healthcare professionals to deliver high value care. ]]> https://biospectrumindia.com/news/97/15408/jaslok-hospital-unveils-second-state-of-the-art-cardiac-cath-lab.html https://biospectrumindia.com/news/97/15408/jaslok-hospital-unveils-second-state-of-the-art-cardiac-cath-lab.html Tue, 24 Dec 2019 10:50:00 +0530 Jaslok Hospital & Research Center, a leading super multi-specialty hospital in Mumbai and amongst the most reputed hospitals in India, has launched a state-of-the-art Cardiac Catheterization Lab equipped with the latest upgraded version of the Philips Azurion, an image-guided therapy platform. This makes this Cath Lab facility the most advanced one, across all hospitals in the city. This is the second Cath Lab to be added in the hospital and will help to cater to the increasing number of patients with heart-related issues in the city. This facility will provide assistance in various heart-related procedures like Angioplasty, Angiography, Rota ablation, intravascular ultrasound, TAVI & other structural heart diseases, Pacemaker, amongst many other procedures. The facility will also help Doctors work with greater confidence and avoid complications, as they will have a image-guided visualization of the patient’s heart, automatically segmented according to the type of procedure recommended.    Speaking at the launch, Mr. Jitendra Haryan, CEO, Jaslok Hospital said, “We have seen a steady increase in the number of cardiovascular cases that the hospital receives and thus adding another advanced Cath Lab will benefit us in treating more number of patients. There is a growing demand for image-guided therapy and increasingly complex procedures, so hospitals are looking for ways to treat more patients in less time without compromising quality of care. Our state-of-the-art Cath Lab will not only increase the  number of procedures done at Jaslok, but doctors would also be able to perform more elective or planned procedures on patients.” Adding to this, Dr. A B Mehta, Head of Cardiology, Jaslok Hospital said, “Cath Lab facility will directly benefit patient outcomes and experience, because it enables clinicians to provide superior care in the interventional lab and provides high productivity at a lower cost of procedure. Specialized facility significantly reduces the patient preparation time (by 12%), expedites procedure time (by 17%) and post procedure lab time (by 28%) while also reduce the scope of delay in providing the planned treatment as per schedule. The facility is specifically designed to provide both high performance for real-time multitasking and an outstanding user experience where interventional team members can work parallelly at flexible work spots without interrupting each other.” The uniqueness of the lab is that it has Live Image Guidance (LIG) to perform the minimal invasive surgery with precision. Apart from LIG the machine also has features such as Intuitive user interface, Physiology Co-registration, Seamless integration into the PCI workflow, Analysis and Device Detection to name a few. It will also provide deeper anatomical understanding to plan and perform TAVR/TAVI, mitral valve replacement and LAAC procedures. Immersive user experience and fully automated tasks simplify planning, measurement, device selection and choice of optimal X-ray viewing angle. As per industry reports, globally there is a steady rise in the number of coronary disease patients and the same trend is visible in India too. Close to 1.7 Million patients die every year due to heart diseases and by 2030, the figure is expected to increase to 23 Million. Adding further from industry statistics, the Cath Lab market globally is estimated to be about 2.5 billion dollars and in India, the market is estimated to be about 1,000 crores. But the demand for Cath labs is eminent with the rising number of cardio vascular patients across the country. Another key highlight of the event was the felicitation of 5 BEST drivers who went beyond their call of duty to save lives of patrons in the city. BEST association conducts CPR trainings for the drivers and support staff as part of their community outreach initiative. These 5 drivers who had received CPR training could identify the commuter under stress as a case of heart attack, and immediately performed CPR on them. This stabilized the patient till they could reach the hospital and thus saved their lives. Dr. A B Metha, Head of Cardiology, Jaslok Hospital was also felicitated for his outstanding contribution in the field of cardiology and nearly half a century service at Jaslok Hospital.  ]]> https://biospectrumindia.com/news/97/15397/ricovr-inks-partnership-with-iit-m-for-poc-testing.html https://biospectrumindia.com/news/97/15397/ricovr-inks-partnership-with-iit-m-for-poc-testing.html Mon, 23 Dec 2019 10:05:00 +0530 Ricovr Inc., a New Jersey based innovative oral diagnostics medical device company, has announced its partnership with renowned engineering organization, the Indian Institute of Technology Madras (IIT-M), India.Ricovr is currently working on building a cutting-edge medical device for point-of-care (PoC) testing using saliva. This collaboration with IIT Madras will help Ricovr advance its Research and Development efforts by bringing together some of the most talented and experienced professionals in the biosensor industry. Ricovr is in the midst of creating a revolutionary product that uses patent-pending nanoscale technology. Their products will benefit businesses, law enforcement officials, and the medical community by providing timely screening and monitoring. Highlighting the impact of this collaboration, Dr. Himanshu Bhatia, Founder and Chief Executive Officer, Ricovr Inc., said, “Ricovr is on its way to being one of the top medical device innovators. Our collaborative efforts with IIT Madras position us to be able to deliver world-class scientific advancements in an exciting emerging space. This partnership will help us attain our goal of developing and commercializing point-of-care medical devices for diverse markets.”This collaboration is taking place during a time of tremendous momentum for Ricovr, which recently expanded its senior leadership team. Ricovr plans to release additional details about its point-of-care diagnostics device in coming months. ]]> https://biospectrumindia.com/news/97/15384/apollo-hospitals-bengaluru-launches-first-robot-assisted-cardiac-surgery-unit-in-india.html https://biospectrumindia.com/news/97/15384/apollo-hospitals-bengaluru-launches-first-robot-assisted-cardiac-surgery-unit-in-india.html Fri, 20 Dec 2019 11:00:00 +0530 Apollo Hospitals Bengaluru, one of the most advanced multi-speciality tertiary care hospitals in the city and part of the Apollo Hospitals Group has announced the launch of the first dedicated Robot-Assisted Cardiac Surgery Unit in India. A milestone in the history of cardiovascular surgery in the country, the Robot-Assisted Cardiac Surgery Unit will offer patients with complex cardiac disease treatment with robotic assisted minimally invasive cardiac surgery. The Robot-Assisted Cardiac Surgery Unit will be equipped with the advanced fourth-generation versatile ‘da Vinci Xi’ robotic surgical system and a dedicated team, led by Dr. Sathyaki P Nambala, Sr. Consultant, Cardio-thoracic and Vascular Surgeon and HoD, Robotic Cardiac Surgery Unit. The advanced fourth-generation versatile ‘da Vinci Xi’ robotic surgical system costs around Rs 25 crore. The team at Apollo will be soon using the system for a bypass surgery. In addition, Apollo plans to open a second dedicated unit of robotic assisted cardiac surgery unit in Mumbai in January 2020. The innovative technology of the da Vinci Xi allows complex cardiovascular surgeries to be performed through smaller incisions and precise motion control, as compared to conventional open heart surgery, which involves opening up the chest by splitting the breastplate. The robot is docked near the operation table while the cardiac surgeon sits on a console from where commands are given to operate the smooth and dexterous robotic arms with a precision that would be impossible without the robot. A high-definition camera provides a clear, 3D view of the chest to the surgeon on a console screen. The da Vinci Surgical System is a robotic surgical system made by the American company Intuitive Surgical. Present in Switzerland, US, Germany, Mexico, Japan, Korea and Taiwan, Intuitive established a direct presence in India in 2018 at Bengaluru. The first da Vinci robotic assisted surgery took place in India nearly two decades ago in a Delhi hospital in 2002.    ]]> https://biospectrumindia.com/news/97/15377/lynx-lawrence-mayo-associates-with-plazma-technologies-to-bring-robotics-solutions-to-india.html https://biospectrumindia.com/news/97/15377/lynx-lawrence-mayo-associates-with-plazma-technologies-to-bring-robotics-solutions-to-india.html Thu, 19 Dec 2019 15:40:00 +0530 Lynx – Lawrence & Mayo recently announced their association with Plazma Technologies, the market leader in superior Robotics Solutions in India. Lynx has been awarded all India Marketing Right by signing an MoU for the Plazma product range. The association is set to fulfill the growing need for robotics automation in the Indian industry. Robotic solutions have revolutionized every major sector in India with the sales of industrial robots reaching a record high of 4,771 units in 2018, a 39% increase compared to the previous year. Ranking eleventh in the world in annual robotic installments, Indian businesses are looking for effective robotics solutions to increase productivity, cut manufacturing costs, and multiply revenue.  Speaking about the Joint Venture, Glenford D’souza, Senior General Manager, Lynx - Lawrence & Mayo said, “We are excited to bring advanced Robotic solutions to Indian industries looking to scale by leveraging the best of technology solutions. And we could not have asked for a better partner than Plazma Technologies for the same. We look forward to a long term, mutually fruitful association that is set to help bring robotics into mainstream industrial process.” With inventive solutions like the RoboPlazma System which allows double side work zone, to adopt multiple job processing capabilities, Plazma Technologies aims to offer greater flexibility of operation. The system is capable of eliminating material handling time and 3D complex job processing with higher efficiency and utilization. Additionally, Plazma Technologies’ Zbot is new generation robotic solution manufactured using the highest quality components from Bosch Rexroth - Servo drives, Motors, Controllers and motion elements to ensure high reliability for serving small, medium and large industries. The Zbot design is patented worldwide and is manufactured under the Make in India initiative. Made through the partnership with Bosch, Germany Zbot can be used for Plasma cutting, Laser cutting, Vision inspection, Welding, Grinding, Pick and Place, Marking, Painting material handling. A reliable and safe solution for all included applications, the Zbot solutions allows a company to eliminate material handling time and increase throughput. Speaking about the association with Lynx - Lawrence and Mayo, Hughen Thomas, Co-Founder and Chairman, Plazma Technologies Pvt. Ltd., said “The culture of Innovations has now come to the Indian shop floor. Adopting advanced technologies is inevitable. The challenge is, how the Indian industry will learn from global challenges and adapt to efficiency. And this is a need that India must recognize. An aggressive investment climate has been created, however, it cannot be sustained unless deep structural reforms take place. The Indian industry needs to ensure that these reforms are sustainable. For this, it has to upgrade its manufacturing and manpower skills. As the global environment gets more competitive than ever before, an adaptive and flexible technological advancement is the need of the hour.” The association between Lynx – Lawrence & Mayo and Plazma Technologies will address the issue of increasing competition and how companies can evolve their businesses through robotic solutions. The solution-based range of robotic products will be facilitated and deployed by Lynx – Lawrence & Mayo and managed by Plazma Technologies including the latest RoboPlazma and Zbot solutions.   ]]> https://biospectrumindia.com/news/97/15370/labcorp-and-covance-virtually-connects-sponsors-with-patients-with-an-expanded-suite-of-decentralized-trial-solutions.html https://biospectrumindia.com/news/97/15370/labcorp-and-covance-virtually-connects-sponsors-with-patients-with-an-expanded-suite-of-decentralized-trial-solutions.html Thu, 19 Dec 2019 11:05:00 +0530 LabCorp, a leading global life sciences company that isdeeply integrated in guiding patient care, unveiled its latest solution for decentralized clinical trials from Covance to help transform the conduct of hybrid and virtual trials. Covance’s cohesive hybrid and virtual clinical trials solution integrates unique capabilities from across Covance and LabCorp, redefining the patient experience to increase participation. It provides a patient-centric ecosystem of conveniently located resources such as LabCorp’s U.S.-based Patient Service Centers (PSC), including LabCorp at Walgreens locations, global partnerships with reputable retail pharmacies, as well as home health phlebotomy and nursing service providers, all connected by a best-in-class technology platform. This decentralized clinical trials offering is underpinned by highly diverse, global data that enables fasteridentification of potential candidates for a trial. The solution seamlessly integrates Covance centrallaboratories, LabCorp specialty diagnostic laboratories, direct-to-patient market access call centers, anda suite of technology solutions to bring the trial closer to the patient, and streamline trial execution.“Covance has long since established itself as a leader in the virtual clinical trial space, with years ofexperience in decentralized trials,” said Bill Hanlon, Ph.D., president, Enterprise Solutions, Covance. “Ourlatest solution includes customized recruitment strategies, a global ecosystem of decentralized andpatient-centric site visit alternatives, and novel ways to visualize trial data. We believe this solution willdisrupt current approaches to expand patient access to studies, provide an improved patientexperience, and accelerate timelines for clinical development.” The Covance decentralized trials offering is powered by a suite of integrated, modular, and highly configurable technology solutions that can be customized to deliver any conforming study protocol. The technology platform supports end-to-end delivery of hybrid and virtual clinical trials by enabling data interoperability and seamless data collection. The platform also can integrate connected devices, wearables and other mobile health, also known as mHealth, technologies to capture primary and secondary endpoint data across multiple indications and connect patients, investigators and decentralized sites. “We have re-imagined decentralized trials with our broad and unique collection of assets, including real-world data, access to a large patient population, a U.S.-based Patient Service Center network, and global logistics and supply chain expertise,” said Bola Oyegunwa, Ph.D., head of Virtual and Hybrid Trials,Covance. “The unique combination of Covance capabilities and data streams, augmented by proprietary LabCorp infrastructure and data assets, plus our widening network of relationships that optimize clinical trials, delivers a more convenient patient experience, overcoming traditional recruitment barriers. This unique combination gives us the ability to partner with clients in a way that works for them to bring their products to market faster, ranging from full-service clinical engagements to functional serviceprovider relationships.” ]]> https://biospectrumindia.com/news/97/15367/medgenome-receives-cap-accreditation.html https://biospectrumindia.com/news/97/15367/medgenome-receives-cap-accreditation.html Thu, 19 Dec 2019 07:30:00 +0530 The accreditation committee of the ‘College of American Pathologist’-CAP has awarded an accreditation to MedGenome Labs Private Limited yet again based on results of a recent on-site inspection as part of their accreditation program. MedGenome is the country’s leading genetic testing laboratory that offers unique genomic solutions in rare diseases, neurology, oncology, infectious diseases, ophthalmology, cardiology and other rare diseases. Dr VL Ramprasad, Lab Director and COO at MedGenome Labs was congratulated for the excellence of the services being provided. He said, “CAP accreditation is the foremost benchmark for running a medical service such as genetic diagnostics. The certification is an encouragement for the team to continue the hard work and innovate to access more and more genetic data that can help us save lives.” This accreditation program is globally recognized as maintaining the highest standards for laboratory quality and having the most up-to-date guidelines regarding diagnostic testing for diseases like cancer. The CAP checklist covers clinical pathology, anatomic pathology, cytopathology, molecular pathology, along with other disciplines plus the overall management and operation of the medical laboratory. With this accreditation, MedGenome Labs are now one of more than 8,000 CAP accredited facilities worldwide, however the only laboratory in India with CAP accreditation for whole genome sequencing. Mr. Sam Santhosh Chairman & Founder-MedGenome Labs said, “We are a firm believer in law and compliance especially when one works in the healthcare sector. This accreditation is yet another proof of the excellence we hold and accuracy we offer”. CAP accreditation process is designed to ensure the highest standard of care for all laboratory patients, inspector examine the laboratory records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management. ]]> https://biospectrumindia.com/news/97/15355/roche-launches-cobas-zika-blood-screening-test-.html https://biospectrumindia.com/news/97/15355/roche-launches-cobas-zika-blood-screening-test-.html Tue, 17 Dec 2019 14:40:00 +0530 Roche has announced the CE-IVD launch of the cobas® Zika test for use on the cobas® 6800/8800 Systems. The cobas Zika test detects Zika virus RNA in samples of human plasma and is intended for use in screening blood donations. Building onto Roche's comprehensive menu of donor screening assays, this launch represents an important milestone in the effort to protect the blood supply from Zika virus globally. Recent news from French authorities reporting three cases of Zika infection apparently acquired locally highlights ongoing Zika activity and the need for blood bank preparedness solutions for tropical diseases. The Zika virus is mainly spread through the bite of infected mosquitoes. However, it is suspected that infected donor blood used for transfusions could serve as an additional transmission route for the Zika virus. "Together with cobas® CHIKV/DENV to screen for chikungunya and dengue viruses, the cobas  Zika test provides a solution for preserving blood safety in regions with local outbreaks of these tropical diseases or from donors who may have been exposed while traveling to outbreak areas," said Mario Torres, Head of Roche Molecular Diagnostics. "Launching the cobas Zika test in markets accepting the CE mark expands the emergency preparedness solution for our customers and helps minimize the risk of transmission through infected blood and plasma donations." Roche worked closely with the U.S. Food and Drug Administration to develop and launch the cobas Zika test in response to a public health crisis and ensure the safety of blood in the U.S. and its territories in 2017. Since then, the cobas Zika test has been used to screen millions of blood donations from the U.S. and Puerto Rico, helping to identify and remove more than 350 potentially infectious donations from the blood supply. Every year, there are more than 117 million blood donations worldwide. One blood donation has the potential to save as many as three lives, making a safe supply of blood and blood products extremely important for any patient that needs a transfusion. Since 2014, the cobas 6800/8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of donor screening, infectious disease, sexual health, transplant, respiratory and antimicrobial stewardship. ]]> https://biospectrumindia.com/news/97/15343/lt-develops-cost-effective-robotic-endo-training-kit.html https://biospectrumindia.com/news/97/15343/lt-develops-cost-effective-robotic-endo-training-kit.html Tue, 17 Dec 2019 10:30:00 +0530 L&T Technology Services Limited, India’s leading pure-play engineering services company, was felicitated for its Robotic Endo-training Kit at the 8th Foundation Day of Global Innovation & Technology Alliance (GITA) on Thursday, 28th November 2019 at Hotel Le Meridien, New Delhi. Hon’ble Minister of Science & Technology, Health and Family Welfare and Earth Sciences Dr. Harsh Vardhan was the Chief Guest, Prof. K. Vijay Raghavan, Principal Scientific Advisor (PSA) to the Government of India and Prof. Ashutosh Sharma, Secretary, Department of Science & Technology, were the Guests of Honour. LTTS was recognized for developing the world’s first cost-effective Robotic Endo-training Kit, in association with GITA and Department of Science and Technology (DST). The research and development for the kit has been a joint effort between India and the Republic of Korea. LTTS’ Robotic Endo-training Kit is a futuristic surgical training robot that gives a high-definition observation of the patient’s anatomy and the instruments - Master Tool Manipulator, Patient Side Manipulator, Endoscopic Camera Arm, Liver VR Feed - have a seven-degree range of movements to improve the precision of surgical techniques. This kit is made at a low cost and hence it can be used by many hospitals or even in smaller clinics to train on inanimate material. Dr. Ramalingam, one of the country’s foremost Laparoscopic Urologists, has been a guide and mentor from the inception of the project, and was instrumental in making it a success. Muralidhara Hosahalli, Global Head of Medical & Life Sciences at L&T Technology Services said, “LTTS’ Robotic Endo-training Kit is a state-of-the-art technology that offers superior vision, improved flexibility, greater accuracy and ergonomic support to surgeons. Through this association with GITA and the Department of Science and Technology we have been able to contribute towards the massive technological shift that is transforming the Indian healthcare industry. Evolving technology is the need of the hour and LTTS’ Robotic Endo-trainer kit helps surgeons to get trained in carrying out most of the complex operations with great precision, flexibility and power as compared to conventional methods.” Ratika Jain, CEO, GITA said, “One of our objectives is to analyze and promote evolving technologies available globally in partnership with global corporates who are leaders in technology. The strategic collaboration with L&T Technology Services on the Robotic Endo-Trainer is part of our vision to strengthen India’s innovation ecosystem. We believe such collaborations are the basis for a more sustainable, technologically advanced and economic development and thank LTTS for lending their rich domain expertise in engineering medical devices.” ]]> https://biospectrumindia.com/news/97/15333/boston-scientific-receives-fda-clearance-for-duodenoscope-exalt-model-d.html https://biospectrumindia.com/news/97/15333/boston-scientific-receives-fda-clearance-for-duodenoscope-exalt-model-d.html Mon, 16 Dec 2019 10:55:00 +0530 Boston Scientific Corporation has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALT™ Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device. This groundbreaking device has been developed as an alternative to reusable duodenoscopes, eliminating the need for duodenoscope reprocessing and repairs, and allowing physicians to use a new, sterile device for every procedure. The EXALT Model D Duodenoscope builds on the familiar design of standard reusable duodenoscopes so that physicians experience a minimal learning curve when adopting this technology. Every year, more than 1.5 million ERCPs are performed worldwide using duodenoscopes to diagnose and treat various pancreatic and biliary conditions. Reusable duodenoscopes are put through a rigorous disinfection process between uses in different patients and the vast majority of procedures with these devices are carried out safely and effectively; however, there have been a small number of cases in which infections have been transmitted between patients via contaminated devices, despite adherence to established protocols. As a result, the FDA has been working with duodenoscope manufacturers, medical societies, physicians and other stakeholders to address this concern. The FDA recently issued a recommendation that healthcare providers transition to duodenoscopes with disposable components or fully disposable devices, when they are available, and held an advisory committee meeting to discuss this process and other issues related to reducing infection transmission by reusable duodenoscopes. Art Butcher, senior vice president and president, Endoscopy, Boston Scientific said, "The EXALT Model D Duodenoscope was developed to support clinicians in their mission to deliver the highest quality patient care. As a leading industry partner committed to advancing the care of pancreaticobiliary diseases for over 30 years, helping to ensure the integrity of ERCP is inherent in our mission to advance science for life and transform patient lives. This device, which was granted Breakthrough Device Designation by the FDA, builds on our legacy of delivering meaningful innovation that improves clinical outcomes." Boston Scientific voluntarily conducted a consecutive case series of the EXALT Model D Duodenoscope and found that expert endoscopists were able to complete ERCPs across a wide range of complexity using the single-use duodenoscope.   ]]> https://biospectrumindia.com/news/97/15317/hcg-first-to-completely-digitise-histopathology-diagnosis.html https://biospectrumindia.com/news/97/15317/hcg-first-to-completely-digitise-histopathology-diagnosis.html Thu, 12 Dec 2019 16:55:00 +0530 Health Care Global Enterprise Ltd. (HCG) a global leader in Cancer Care becomes the first hospital in the country to completely digitise histopathology workflow for primary diagnosis at the HCG-Strand Laboratory at KR Road, Bengaluru. The hospital had introduced a US FDA approved digital pathology solution from Philips Intellisite Pathology Solutions and now the laboratory at HCG has successfully transformed to a 100% digital lab for Histopathology and Computational Pathology. The lab is also now accredited by College of American Pathologists (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL), India, for its Digital Pathology facility in the fields of Histopathology, Cytopathology, Frozen section facility as well as the Artificial Intelligence based Breast Algorithm. Digital diagnosis is now the default diagnosis of the lab for surgical pathology and 100% of FFPE slides (formalin-fixed paraffin-embedded) are digitally scanned into high-resolution digital images. These are then viewed, analysed, annotated and shared with other pathologists in the network in real time. Majority of the pathologists in the laboratory are now working digitally. 100% digital Histopathology labs helps patients by providing more accurate results and ease of access to expert opinions. It significantly improves the turnaround time for reports as well as cost saving in terms of glass logistics of slides and blocks.  Digitization also means there is no longer worry about the risk of losing or damaging specimens in the transit. Speaking on the occasion, Dr. B S Ajaikumar, Chairman & CEO, HCG said, “With the 100% digitalisation of Histopathology services, HCG has moved further in revolutionising cancer treatment, making it possible to focus on improved outcomes for patients. These digital images are powerful tools for pathologists, helping them to analyse samples and prepare histopathology reports more accurately and efficiently.  This technology marks a step forward in cancer treatment through precision, speed, efficiency and ease of use with immense potential to provide significant clinical benefits to both the physicians and patients”. Dr. Veena R, Consultant Pathologist, Head of Histopathology, Strand Life Sciences, Bangalore said, “With increasing incidence of cancer cases, pathologists have to manage the increasing workload more efficiently and this is possible through streamlining the workflow, sharpening diagnostic skills and facilitating partnership. Digital pathology helps in improving the efficiency of pathologists and quality of cancer diagnosis by enhancing collaboration across care teams and improving time to diagnosis. A pathologist takes almost one hour to report a case of Radical Prostatectomy while on digital slides it can be reported in 30min more accurately. In the era of precision medicine, where treatment options are tailor made for each patient, pathologists adapting to latest technological advancements, such as digital pathology is a welcome sign. Corporate hospitals abroad have successfully transformed to 100% digitization, and now India is following. While digital pathology improves workflow in Histopathology, Computational Pathology is helping the pathologists to use digital images in more varied and efficient ways. Smart image recognition algorithms, in future, will help the pathologists to focus on the things that matter most”. ]]> https://biospectrumindia.com/news/97/15287/philips-inks-50m-deal-with-inspira-health.html https://biospectrumindia.com/news/97/15287/philips-inks-50m-deal-with-inspira-health.html Mon, 09 Dec 2019 12:20:00 +0530 Royal Philips, a global leader in health technology, and Inspira Health (Inspira), have announced a strategic 5-year partnership agreement worth $50 million to standardize patient monitoring and drive innovation in diagnostic imaging solutions in order to enhance patient care and improve clinical workflow performance. The agreement will make Philips solutions available to more than a dozen Inspira health facilities, helping the charitable non-profit fulfill its commitment to provide access to the highest quality medical services. The contract also includes training and services that will maximize Inspira’s operational efficiency. Long-term strategic partnerships (LSPs) are a growing trend used within hospitals and health systems to better manage the cost and complexity of their technology investments over a defined period, while expanding quality access to advanced medical care in order to improve patient outcomes. Philips is a leader in LSPs and will provide Inspira with the latest in diagnostic imaging solutions, patient care monitoring systems, and minimally invasive solutions such as the Philips Azurion image-guided therapy platform. Driven by benefits for patients and care providers, minimally invasive therapies such as the catheter-based treatment of certain tumors, aneurysms, obstructed blood vessels, heart rhythm disorders and defective heart valves continue to grow fast. These therapies are also more cost-effective and support Inspira’s vision of providing quality care for its communities, with a focus on cancer and cardiac care. Long-term strategic partnerships also provide forward-thinking organizations like Inspira with a predictable and stable financial model, while helping to take the guesswork out of technology adoption. It will allow Inspira to standardize its diagnostic imaging and patient monitoring technologies across the network, making data more integrated and allowing clinicians to get access to the right patient data, which will facilitate better diagnosis and treatment. ]]> https://biospectrumindia.com/news/97/15279/nathealth-highlights-challenges-in-diagnostics-sector.html https://biospectrumindia.com/news/97/15279/nathealth-highlights-challenges-in-diagnostics-sector.html Mon, 09 Dec 2019 07:15:00 +0530 NATHEALTH Diagnostic Study was recently released by Dr Vinod Paul, Member (Health), NITI Aayog during the 6th Annual Summit of the Federation. The report highlights the challenges and opportunities in the Lab Diagnostic segment which is an important pivot to India’s response to the twin challenges of communicable and non-communicable diseases. The Indian Diagnostic industry plays a critical role in the achievement of the vision of Universal Health Coverage (UHC) as well as the Sustainable Development Goals (SDGs). The industry, however, suffers from a limited focus on quality standards and cost pressures driven by high custom duty and the Goods and Services Tax(GST)structure, reveals a Diagnostic Study, released by Healthcare Federation of India-NATHEALTH. The report highlights, “Going forward, the government and industry should come together and efforts should be made towards laying down minimum quality requirements, easing of custom duty and extending input tax credits for GST.” “The lab diagnostics industry plays a significant role in the care continuum. The growing importance of evidence-based medicine has provided a fillip to the industry. Along with its core objective of diagnosis, the industry offers additional benefits, be it employment generation, availability of specialised tests, improved access, and technological advancements, among others,” the study points out. Commenting on the findings of the Study, Dr Sudarshan Ballal, President, NATHEALTH said, “A robust diagnostic ecosystem is critical for the success of schemes like Ayushman Bharat to establish minimum quality requirements, easing of custom duty and extension of input tax credits for the Goods and Services Tax (GST). Such policy measures would support the diagnostic segment to ensure that the benefits of quality diagnostics and wellness can be delivered to the country as a whole.” The Indian medical diagnostics industry today employs around 0.8 million people with almost 3–4 direct jobs and 3–6 indirect jobs created per new diagnostics establishment, says the Study. According to the study, the Indian laboratory diagnostics industry, estimated at USD 6 billion, is growing at a healthy rate of 13–14% per annum. With more than 1 lakh labs in India, the industry is highly fragmented and the largest of the organised players have a market share of less than 5%. The industry plays a significant role in the care continuum, be it for diagnosis, prevention, monitoring or treatment. Today, 70% of medical decisions are based on laboratory results. The industry today is governed by forces of supply and demand, with service quality driving market success. The value chain in the industry today has three core components – clinical, retail and logistics. Concerning the clinical component, the industry has matured and today offers a comprehensive array of tests at affordable prices. The industry operates at one of the lowest price points in the world. Even at these low rates, the Indian medical diagnostics industry has been able to provide people living in remote areas access to modern diagnostics facilities. The prices have remained flat or at best increased by 5–10% in the last 5 years, while the consumer price index (CPI) price inflation has grown by around 30%. The retail component is highlighted by the doorstep presence of the industry, same-day delivery of lab reports, high customer satisfaction and other advances made in making the whole experience a relatively pleasant one. The last component, logistics, is highlighted in the processes deployed by labs to collect samples from collection centres and transfer them to the central lab for processing.  These three components have transformed the industry into a service industry, with retail and logistics component accounting for more than 50% of the costs. This has enabled access to modern diagnostics in more than 50% of the aspirational districts of the country. Siddhartha Bhattacharya, Secretary General, NATHEALTH commented, “The Study has assessed India’s Laboratory Diagnostic Industry and highlights the role played by the Industry in improving Indian Healthcare in terms of Accessibility, Affordability, and Accountability. The industry has created social capital in the form of nearly 8 lakh jobs and skilling opportunities. We, at NATHEALTH, are committed to partner with the government to achieve the SDG 2030.” The launch of Ayushman Bharat is a significant step towards achieving the goal of UHC. The lab diagnostics industry would need to play a key role in the realisation of this goal. “Wellness centres are an important pillar for Ayushman Bharat, with the government aiming to set up 1.5 lakh such centres across the country. NITI Aayog has called for making these centres operational by 2022–23 to ensure sufficient coverage and lower the burden on secondary and tertiary care. The diagnostics industry will play a critical role in making this a reality while working closely with the government,” the study emphasises. Given the right impetus, the industry can play an important role in the health and economic well-being of the country by: Creating Job opportunities  Increasing access to diagnostics Becoming a diagnostics centre of excellence in the region  Providing entrepreneurship opportunities Advanced personalised test menu Increase trained and highly skilled manpower  Ensuring the success of Ayushman Bharat   ]]> https://biospectrumindia.com/news/97/15270/roche-set-to-market-mrsa-bacteria-diagnosis-test.html https://biospectrumindia.com/news/97/15270/roche-set-to-market-mrsa-bacteria-diagnosis-test.html Fri, 06 Dec 2019 11:05:00 +0530 The U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed. “Diagnostics that are able to provide accurate results more quickly can offer health care providers an advantage when trying to prevent and contain the spread of resistant bacteria,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s authorization adds a new tool in the fight to prevent and control MRSA in high-risk settings. The FDA remains committed to supporting efforts to address antimicrobial resistance in order to better protect patients against this ongoing public health challenge.” MRSA is a type of bacteria that can lead to serious illness, and even death, if a patient develops an infection. According to the Centers for Disease Control and Prevention (CDC), approximately 5% of U.S. hospital patients carry the MRSA bacteria, although many of those that carry the bacteria do not develop infections. MRSA has been defined as a serious antimicrobial resistant threat by the CDC. It is resistant to many common antibiotics, which means that if infections develop they can be very challenging to treat and control. The use of active screening to detect MRSA colonization and enable implementation of infection control measures has played an important role in reducing the rates of MRSA infection. The CDC estimates that there were more than 323,000 MRSA cases in hospitalized patients in the U.S. and more than 10,000 deaths in 2017.   The cobas vivoDx MRSA test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as little as 5 hours compared to 24-48 hours for conventional culture. Diagnostic tests that can more quickly and easily detect MRSA could benefit patient care and may help healthcare providers prevent the spread of MRSA. The FDA reviewed data from performance studies in which the cobas vivoDx MRSA test correctly identified MRSA in approximately 90% of samples where MRSA was present and correctly identified no MRSA in 98.6% of samples that did not have MRSA present. The cobas vivoDx MRSA test authorized today is intended to aid in the prevention and control of MRSA infections in healthcare settings and can be used to identify patients needing enhanced precautions for infection control such as isolation and additional decolonization efforts. The FDA reviewed the cobas vivoDx MRSA test through the de novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for tests of this type, including requirements relating to labeling and design verification and validation to address certain risks, such as false positives.  When met, the special controls, along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device. The FDA granted marketing authorization of the cobas vivoDx MRSA test to Roche Molecular Systems Inc. ]]> https://biospectrumindia.com/news/97/15260/mtai-all-set-for-3rd-edition-of-mtai-medtekon-.html https://biospectrumindia.com/news/97/15260/mtai-all-set-for-3rd-edition-of-mtai-medtekon-.html Thu, 05 Dec 2019 07:00:00 +0530 Medical Technology Association of India (MTaI) is organizing its flagship event ‘MTaI MedTekon 2019’ on 20th December 2019 to deliberate upon ‘Fostering & Fortifying Ayushman Bharat’s Foundations’. Dr. Harsh Vardhan, Minister of Health & Family Welfare has been invited to inaugurate the MTaI MedTekon 2019 in New Delhi. The convention will have participation from key ministries, public and private sector think tanks, hospital groups, healthcare investors, patient groups, insurance industry, medical technology and pharmaceutical industry among others. Ayushman Bharat was launched last year as the Centre’s flagship health program to provide access to affordable healthcare for the un-served and under-served. The scheme covers 50 crore people from low-income households. Beneficiaries could avail treatment for specific medical conditions in hospitals that have enrolled in the program. More than 47 lakh people availed treatment in the first year of the scheme. The Ayushman Bharat program rests on four pillars - Providers, Insurance Industry, Investors and the MedTech/Pharma Industry – and the program’s success will depend on involving each stakeholder in implementation. Badhri Iyengar, MTaI Director said, “We are organizing MedTekon 2019 at a crucial time. Ayushman Bharat has just completed the first year of its implementation and the learning and experiences need to be studied to understand the areas which require reinforcements. MedTekon 2019 will have participation from all key stakeholders of the healthcare space and will deliberate on how each of them can play its role most effectively.” Diwaker Rana, MTaI Director said, “The first MedTekon talked about demystifying the MedTech sector, the second MedTekon discussed MedTech’s role in vitalizing Ayushman Bharat. This year’s MedTekon will facilitate a deeper conversation on Ayushman Bharat to strengthen the four pillars of the scheme.” About MedTekon 2019 A successful universal healthcare program will require a robust and well co-ordinated system to serve India’s un-served and the under-served. MTaI MedTekon 2019 will bring together the vital pillars on which Ayushman Bharat rests- the Providers, Payers, Investors & the Medical Technology (MedTech) Industry to deliberate on the way forward to be even more effective and far reaching and achieve its underlining commitment, which is to “leave no one behind”. MTaI, which believes in greater patient access and represents a wide spectrum of medical devices & equipment, has taken this opportunity to call upon stakeholders for a 360° discussion and deliberation on ‘Fostering & Fortifying Ayushman Bharat’s Foundations’. The sessions will be delivered by esteemed panellists, which will include policy decision makers from the Government, leaders from MedTech Industry, Patient Groups, Hospitals, Healthcare Investors, and Insurance Company representatives.   ]]> https://biospectrumindia.com/news/97/15247/novel-mri-guided-ultrasound-treatment-destroys-prostate-cancer.html https://biospectrumindia.com/news/97/15247/novel-mri-guided-ultrasound-treatment-destroys-prostate-cancer.html Mon, 02 Dec 2019 17:40:00 +0530 A novel MRI-guided procedure that uses therapeutic ultrasound effectively treats prostate cancer with minimal side effects, according to a new study presented at the annual meeting of the Radiological Society of North America (RSNA) recently. Researchers said the incision-free technique could also be used to treat benign enlargement of the prostate gland. Prostate cancer is the second-leading cause of cancer death in men after lung cancer. Treating disease in the small gland that surrounds the urethra just outside the bladder is challenging. Surgery and radiation are not always effective and can result in incontinence, impotence and bowel dysfunction. Other currently available techniques lack sophisticated imaging guidance and temperature monitoring. In recent years, a minimally invasive method called MRI-guided transurethral ultrasound ablation (TULSA) has emerged as a promising treatment option. TULSA works by delivering precise doses of sound waves to diseased prostate tissue while sparing the healthy nerve tissue surrounding the prostate. TULSA relies on a rod-shaped device that is inserted into the urethra. The novel device has 10 ultrasound-generating elements that can cover the entire prostate gland. One or more of the elements are used to send out sound waves that heat and destroy the target prostate tissue. The elements are controlled automatically by a software algorithm that can adjust the shape, direction and strength of the therapeutic ultrasound beam. The entire procedure takes place in an MRI scanner so that doctors can closely monitor treatment and assess the degree and location of heating. "Unlike with other ultrasound systems on the market, you can monitor the ultrasound ablation process in real time and get immediate MRI feedback of the thermal dose and efficacy," said study co-author Steven S. Raman, M.D., professor of radiology and urology, and director of Prostate MR Imaging and Interventions and Prostate MR Imaging Research at the University of California at Los Angeles (UCLA). "It's an outpatient procedure with minimal recovery time." In the new multicenter study, researchers reported on the 12-month outcomes from the TULSA-PRO® ablation clinical trial (TACT). The trial enrolled 115 men, median age 65, with localized low or intermediate risk, gland-confined prostate cancer. Clinicians delivered TULSA treatment to the entire gland. Treatment time averaged 51 minutes.  Prostate volume in the study group decreased on average from 39 cubic centimeters pre-treatment to 3.8 cubic centimeters a year after treatment. Overall, clinically significant cancer was eliminated in 80% of the study participants. Seventy-two out of 111 men, or 65%, had no evidence of any cancer at biopsy after one year. Blood levels of prostate-specific antigen (PSA), a marker of prostate cancer, fell by a median of 95%. There were low rates of severe toxicity and no bowel complications. "We saw very good results in the patients, with a dramatic reduction of over 90 percent in prostate volume and low rates of impotence with almost no incontinence," Dr. Raman said. Approved for clinical use in Europe, TULSA has just received FDA 510(k) clearance for prostate tissue ablation in the United States. Assuming follow-up studies support the preliminary results, the technique could develop into an important tool for treating both prostate cancer and benign prostatic hyperplasia, or enlargement of the prostate. "There are two very unique things about this system," Dr. Raman said. "First, you can control with much more finesse where you're going to treat, preserving continence and sexual function. Second, you can do this for both diffuse and localized prostate cancer and benign diseases, including benign hyperplasia." TULSA also has the benefit of allowing further treatment if needed, Dr. Raman said. If it fails, then the procedure can be repeated, and more aggressive invasive approaches like surgery and radiation therapy can still be used. Alternatively, TULSA may enable noninvasive treatment for localized radiation failure. The study also supports the use of MRI for post-treatment monitoring of patients who undergo TULSA. MRI at one year after treatment had a negative predictive value of 93 to 96% for detecting residual cancer, meaning it was very accurate for ruling out disease recurrence in patients. ]]> https://biospectrumindia.com/news/97/15246/medtronic-introduces-mazor-x-stealth-edition-in-india.html https://biospectrumindia.com/news/97/15246/medtronic-introduces-mazor-x-stealth-edition-in-india.html Mon, 02 Dec 2019 15:35:00 +0530 India Medtronic Private Limited has announced the launch of the Mazor X Stealth Edition™ that offers a fully-integrated procedural solution for surgical planning, workflow, execution and confirmation of spine surgeries. Surgeons at Indian Spinal Injuries Centre, New Delhi, have successfully performed the first minimally invasive spine surgery in India using the Mazor X Stealth Edition Robotic-Assisted Spine Surgery System. The global surgical robotics market has a vast potential, and it is expected to grow to US$9.3 billion by 2025 from US$4.9 billion back in 2016 with a CAGR of 11.4%1. In India, with a rapidly growing senior population, the spine surgery rate is expected to rise. The Surgical Robotics Market in India is predicted to witness a remarkable increase from US$129.9 million in 2016 to US$372.5 million in 2025, growing at a CAGR of 19.2%. Dr. H.S. Chhabra, medical director, Indian Spinal Injuries Centre, New Delhi said “Minimally-invasive spinal procedures with their smaller incisions can pose a challenge to surgeons due to the limited view of the patient's anatomy. The combination of robotics and navigation provides an opportunity for not only procedural benefits but also the potential for clinical efficiency and improvement in patient outcomes. We can now perform the same spinal surgery with precision as planned along with the ability to confirm through navigation that the implant is going in the location as it was intended to.” Madan Krishnan, Vice President and Managing Director, India Medtronic Pvt Ltd. said, “We believe technology has the power to improve lives. That's why we are continually innovating novel products and procedural solutions in the area of minimally invasive therapies; to improve the quality of life for all patients. We are bringing a myriad of new technologies to India to improve access to the best treatment options for patients. This year being the 40th year for Medtronic in India, we are happy to demonstrate our commitment to transforming healthcare in India with renewed vigour by launching the Mazor X Stealth Edition Robotic-assisted Spine Surgery System." Co-developed between Medtronic and the recently acquired Mazor Robotics, the Mazor X Stealth Edition seamlessly incorporates Stealth™ software technology into the Mazor X™ robotic-assisted surgery platform. It uses cutting-edge software to plan the surgical procedure, then uses a robotic arm to guide implants and instruments through the steps of the surgical process with precision, while simultaneously using real-time imaging feedback to ensure the plan is being carried out as desired. The Mazor X Stealth Edition operates on three principals: first, the surgeon can plan and visualize the surgery beforehand to study multiple levels and the entire process; second, the robotic guidance system will be an extension of the doctor during the process and is intended to enable execution with precision; and third, the doctor can visualize progress in real-time.   ]]> https://biospectrumindia.com/news/97/15225/centres-public-procurement-directive-to-states-may-end-up-restricting-competition-mtai.html https://biospectrumindia.com/news/97/15225/centres-public-procurement-directive-to-states-may-end-up-restricting-competition-mtai.html Thu, 28 Nov 2019 17:40:00 +0530 The Central Government’s directive to states to prefer indigenously manufactured medical devices for public procurement may end up restricting competition rather than creating a level-playing field. The timing of the directive, issued this month, is surprising as the industry is actively discussing the means to streamline public procurement of medical devices without disturbing the demand-supply equation. It is noteworthy that more than 70% of the demand for medical devices is being met by global companies with a large footprint of investment in manufacturing, R&D and training of healthcare workers in India. These companies operate in multiple countries and therefore adhere to international standards such as USFDA or CE that are recognised in India as well as all other nations. The recent directive seems to have ignored these facts in asking states to prefer Indian drug regulatory certification for public procurement. In a way, the directive limits the export potential of Indian companies by allowing them to conform to Indian certification alone, because USFDA and CE are considered as the standard for procurement in the global arena. In 2018, the Central Government had issued draft guidelines for public procurement, stipulating that medical devices should have a minimum local content of 25-50 per cent to qualify for public procurement. At that time, MTaI had said a uniform requirement of 25-50 per cent local content without  considering the missing ecosystem for manufacturing sophisticated medical devices and equipment will create a risk of 'garage manufacturing' with low cost low quality Chinese knocked-down kits based assembly. At present, India has got adequate manufacturing capabilities for products like syringes, cannulae, stop cocks, dressings, hospital furniture, etc. but lacks the desired ecosystem for devices like heart lung machines, pacemakers, complex catheters etc. The government has shown interest in developing this ecosystem and is engaging with stakeholders to understand the nurture and nudge it requires.  “The definition of local content in public procurement tenders need to be reworked. Keeping the wide spectrum of products in the medical device sector in mind as well as staying mindful of the fact that no large company makes its entire range in one destination, a company that’s making any part of this wide range of products in significant volume should be considered as domestic manufacturer. The range which a company chooses will naturally depend on the ecosystem available. Also, at present India does not have adequate manufacturing capacity of manufacturing Class C & D devices, therefore these should be exempted from PPO” says Pavan Choudary, MTaI Chairman and Director General. Choudary adds that the DoP (Department of Pharmaceuticals) is taking an inclusive approach to understand the concerns of all stakeholders in the industry but measures such as the recent directive on public procurement seems to ignore the concerns of global companies, which are the largest stakeholder at present. The DoP had recently called for a stakeholders meeting to discuss regulation of tariffs on medical devices as well as to take suggestions to increase FDI and promote manufacturing in India. FDI in medical devices had dipped to $66 million in 2018 from $439 million in 2016. “It is reassuring to see that the government is taking an inclusive approach to understand the concerns of the industry. MTaI has been engaging with the Department of Pharmaceuticals and the Invest India team closely to work on several corrective measures which will help bring FDI back on track and promote investments in the medical device sector. The government needs to evaluate which group brings investments and which only bring promises. This is a capital intensive and technology intensive sector which is why for the growth of this sector, the participation of western countries and countries like Japan and Korea is vital,” says Choudary.   ]]> https://biospectrumindia.com/news/97/15221/qiagen-diasorin-gets-fda-approval-for-latent-tb-test.html https://biospectrumindia.com/news/97/15221/qiagen-diasorin-gets-fda-approval-for-latent-tb-test.html Thu, 28 Nov 2019 16:00:00 +0530 QIAGEN and DiaSorin have announced the U.S. launch of an automated workflow for QuantiFERON-TB Plus (QFT-Plus), the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms. The U.S. Food and Drug Administration (FDA) approved the LIAISON QuantiFERON-TB Plus Test, developed by QIAGEN and DiaSorin to offer streamlined laboratory automation for latent TB screening, supporting the conversion from tuberculin skin tests to modern blood-based QuantiFERON technology. The highly automated workflow on LIAISON platforms provides QuantiFERON customers a powerful, highly flexible automation option for all throughput ranges. Embedding QuantiFERON assays in the broad assay menu of DiaSorin’s LIAISON analyzers also gives current LIAISON customers an attractive new assay option with significant growth potential. The workflow pairs QIAGEN’s standard QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT, containing the core QuantiFERON technology) with DiaSorin’s newly launched LIAISON QuantiFERON-TB Plus detection assay. More than 8,000 LIAISON systems have been placed worldwide, primarily in hospital laboratories. ]]> https://biospectrumindia.com/news/97/15218/nephroplus-to-expand-services-in-se-w-asia.html https://biospectrumindia.com/news/97/15218/nephroplus-to-expand-services-in-se-w-asia.html Thu, 28 Nov 2019 12:50:00 +0530 Setting sights on expanding their services in dialysis care, NephroPlus, India’s largest dialysis center network is foraying into International markets beginning with West Asia and South East Asia. The center which is focused at redefining dialysis treatment, received an investment of $45 million (Rs 323 crore) from Investcorp, a Bahrain based, Global alternative asset management company. With a footprint of a notable dialysis network in the country with over 200 centers, NephroPlus has been providing cost effect treatments to over 14,000 dialysis patients. With the latest investment, the company is looking at expanding beyond their current presence in 20 states of India. The funds will further be for acquisitions and partnerships commencing with Indonesia, Philippines, Vietnam, Saudi Arabia and Bahrain. A contract with Vietnam is currently underway and will be effective within the next two- three months. The focus for the Indian market will continue to develop through the dialysis programmes currently on track at 180 hospitals and will subsequently continue through select acquisitions and expansion of centers; joint ventures and new operation and maintenance contracts will also be set in motion. Speaking about the big-ticket announcement, Vikram Vuppala, Founder & CEO, NephroPlus, said, “My partner Kamal Shah and I are excited on this newest development, our partnership with Investcorp will help transform the healthcare industries in India and overseas. With our current growth rate through our existing services, we are now aiming at a rapid growth through this investment”. Further commenting on the company’s hindsight of future developments in Indian and International markets, Vuppala says, “Through acquisitions and joint ventures, we are hoping to set-up 75-100 centers in the 5 International markets within the next three years. In India, we are aiming to grow momentum by expanding to 40 centers every year through our high quality but cost-effective models”. ]]> https://biospectrumindia.com/news/97/15217/medtronics-dcb-gets-fda-nod-to-treat-arteriovenous-fistula-lesions.html https://biospectrumindia.com/news/97/15217/medtronics-dcb-gets-fda-nod-to-treat-arteriovenous-fistula-lesions.html Thu, 28 Nov 2019 11:00:00 +0530 Medtronic plc has announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT™ AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis. AV fistulae are created and used to enable hemodialysis for patients with ESRD. Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three maintenance procedures per year, which can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system. Pivotal randomized trial results from the IN.PACT AV Access trial have shown IN.PACT AV DCB can extend the time between reinterventions by maintaining AV access site patency, therefore maximizing a patient’s uninterrupted access to lifesaving dialysis care. “In many cases, AV fistula are considered lifelines for patients with ESRD as they are the primary access point for life-saving dialysis treatment. When these access sites fail, patients experience delays in their dialysis treatment and require multiple reinterventions to keep the site functioning,” said Vincent Gallo, M.D., interventional radiologist at Holy Name Medical Center in Teaneck, New Jersey and an investigator for the IN.PACT AV Access trial. “With this approval physicians now have access to a safe and extremely effective therapy to slow the progression of restenosis, which results in fewer reinterventions and disruptions in care for these patients.” IN.PACT AV DCB, leveraging technology from Medtronic’s IN.PACT™ Admiral™ platform, increases blood flow and reduces thickening of the vessel wall by delivering the proven anti-proliferative drug paclitaxel. This drug penetrates deep into the vessel wall to prevent restenosis and has the potential to extend time between reinterventions. In 2016, the CE Mark indication for IN.PACT Admiral DCB was expanded for the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease undergoing dialysis. “The FDA approval of IN.PACT AV DCB marks a significant step forward for paclitaxel-coated devices. Importantly, it allows us to expand our proven IN.PACT DCB platform beyond the superficial femoral artery,” said Mark Pacyna, vice president and general manager of the Peripheral Vascular business in the Medtronic Cardiac & Vascular Group. “We are excited to bring this technology to physicians in the U.S. and to help improve the lives of patients living with ESRD.” ]]> https://biospectrumindia.com/news/97/15215/iit-m-aids-aindra-systems-in-developing-cervical-cancer-screening-device.html https://biospectrumindia.com/news/97/15215/iit-m-aids-aindra-systems-in-developing-cervical-cancer-screening-device.html Wed, 27 Nov 2019 13:45:00 +0530 Indian Institute of Technology Mandi (IIT M) researchers have contributed in developing an Artificial Intelligence-powered point-of-care device to screen for cervical cancer by analysing microscopy images with high accuracy. This project has been taken up in collaboration with Aindra Systems Pvt. Ltd., Bengaluru. The research was undertaken by a team led by Dr. Anil Sao and Dr. Arnav Bhavsar, Associate Professors, School of Computing and Electrical Engineering, IIT Mandi with their research scholars Ms. Srishti Gautam and Ms. Krati Gupta. The team, along with the industry collaborators, has developed AI-based algorithms that enables the device to undertake automatic screening for cervical cancer. Cervical Cancer is among deadliest forms of cancer.  Early detection and treatment are vital for those diagnosed with cervical cancer.  The gold standard in screening for cervical cancer is the ‘Pap smear test,’ in which, cells extracted from the cervix are examined by specialists using a microscope. While the Pap smear test has undoubtedly helped in early detection of cervical cancer, it involves subjective analysis and is associated with risks of false diagnoses; various research studies have shown the accuracy of the Pap smear test to range between 60 per cent and 85 per cent.  Pap smear test has been the standard examination for testing for Cervical Cancer. However, the patients need to travel to the hospital for this test and this could be a problem, particularly in geographically distant areas or in regions without basic diagnostic infrastructure, there could be delays in interpreting results.  Speaking about the practical advantages of the device created during this Research, Dr. Arnav Bhavsar said, “The difference between a conventional system and Aindra’s point-of-care system is that, the latter is portable and can be taken to the potential patients. In the conventional system, the people have to visit the pathology laboratory to get themselves screened.” Mr. Adarsh Natrajan, Mr. Harinarayanan and Mr. Nirmal Jith from Aindra Systems Pvt. Ltd. collaborated on the design and the development of the device. They have applied for an international patent for the device and algorithm in 2016 and their research results have been published in many international journals and conference proceedings in the past two years.  The device prototypes are currently undergoing clinical testing at Kidwai Memorial Hospital, Bengaluru, Manipal Hospital, Karnataka and Raja Rajeswari Medical College and Hospital, Bengaluru.  The accuracy of the developed prototypes has been consistently around 88 per cent. The IIT Mandi team first analysed Pap smear images provided by the industrial partner, Aindra, and characterized them into ‘normal’ and ‘potentially cancerous.’ They developed a computer program that could differentiate between the two. “We could demonstrate performance improvements over some of the contemporary methods, with relatively simpler, and arguably more efficient methods”, said Dr. Bhavsar. The developed algorithm is based on the recent deep learning paradigm of artificial intelligence. The advantage of this type of program is that it can be used in situations where in one can encounter a large amount and variability in data. Speaking on the relevance and importance of this algorithm and device, Dr. Anil Sao said, “Given the shortage of pathologists in India, these algorithms will help in automating the process of screening Pap -Smear images. Thus, there will be a significant reduction in time spent by the pathologist, thereby reducing cost and improving the screening accuracy.” The classification of cervical cells as normal or abnormal depends on segmentation/differentiation of the nucleus of the cell.  The researchers have also developed an efficient pre-processing technique to detect cells in images, which were then subjected to the Convolution Neural Network algorithm, for accurate classification of cancer cells. Work related to this development is described in papers in the Workshop on Computational Pathology 2018, and in Proceedings of Society of Photo-optical Instrumentation Engineers (SPIE) 2018. ]]> https://biospectrumindia.com/news/97/15186/lupin-launches-smart-device-adhero-in-india-.html https://biospectrumindia.com/news/97/15186/lupin-launches-smart-device-adhero-in-india-.html Mon, 25 Nov 2019 09:00:00 +0530 Pharma major Lupin Limited (Lupin) announced the launch of “ADHERO,” a new connected smart device for metered-dose inhalers. This first-of-its-kind device is designed to help patients with chronic respiratory diseases track their MDI usage and facilitate improved adherence to therapy. Inhalers are the preferred treatment option for managing the rising incidence of Chronic respiratory diseases like Asthma and COPD in India. However, it is estimated that nearly 45 percent patients do not adhere to therapy (in terms of filling / refilling prescriptions or maintaining prescribed medication schedule), which adversely impacts clinical outcomes and patient quality of life. The new device, ADHERO, is designed to improve patient adherence to therapy. Lupin has collaborated with Aptar Pharma, a leading provider of drug delivery devices, components and services in bringing this first in class device to market. ADHERO is a bluetooth-enabled, reusable smart device which attaches to the top of a MDI. With built-in sensors, the device tracks the patient’s daily medication usage and consumption patterns. Patients can access this information by connecting their ADHERO device to the “MyAdhero” app on their smartphones. The app is also equipped to send reminders, provide contextual health alerts based on factors like Air Quality Index (AQI) at the patient’s current location and enable visual analytics. Physicians too can access patient-related information and medication tracking data through the patient dashboard portal as well as through the app. Speaking on the launch, Rajeev Sibal, President India Region Formulations, Lupin Limited, said, “Lupin lays great emphasis on three aspects of Respiratory Medicine, namely Disease Awareness, Diagnosis and Adherence. The launch of ADHERO will be a great help to patients using metered dose inhalers, as well as, for Doctors to track adherence and compliance to therapy, thereby improving clinical outcomes and quality of life of patients.” ]]> https://biospectrumindia.com/news/97/15180/srl-dr-avinash-phadke-labs-unveils-antibiotic-resistance-status-of-mumbai.html https://biospectrumindia.com/news/97/15180/srl-dr-avinash-phadke-labs-unveils-antibiotic-resistance-status-of-mumbai.html Fri, 22 Nov 2019 12:40:00 +0530 SRL Dr Avinash Phadke Labs, one of the city's oldest and reputed chain of pathology labs, unveiled ‘Mumbai’s Antimicrobial Resistance Report, 2019’ highlighting the patterns observed in bacterial infections and antibiotic resistance affecting Mumbaikars.  The objective of the report is to contribute to the reduction of Antimicrobial Resistance (AMR) that is impacting people world over. AMR differs regionally and it is important for all stakeholders to be aware of the trends impacting the city, so that precautionary and corrective measures can be taken to limit the spread of antibiotic resistance. The report is based on the study of 40500 selected samples received over 9 months (January to September 2019) from Mumbai. Top findings of the report are as follows: ●       Top bacterial organisms affecting Mumbaikars: Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Acinetobacter baumannii, Salmonella typhi ●       Top infections caused by these organisms are: Urinary Tract Infections (UTIs), Soft tissue/wound infections, Respiratory Tract Infections, Typhoid and Sepsis. ●       Antibiotics Mumbaikars are most resistant to:  Penicillin, Cephalosporin (up to2nd generation) and Fluoroquinolones (up to 2nd generation) The report also highlights antibiotics that could be possibly used in drug-resistant bacteria cases. Commenting on the cause, Dr. Ajay Phadke, Centre Head, SRL Dr Avinash Phadke Labs, said, “Antimicrobial resistance has become a global concern and the onus of reducing its spread lies on each one of us.  Efforts need to be made right from infection control to judicious use of antibiotics.  A shift in the way diagnosis of bacterial infections is ordered and antibiotics are administered is critical. Even the general public needs to be made aware about the ill effects of irrational and rampant antibiotic usage. On a broader level, regional monitoring of AMR and improvement of local antimicrobial stewardship is required. Technology backed platforms can be used to integrate information on antimicrobials and resistance from different localities so that clinicians are aided in offering better patient care and fighting AMR through a connected approach.” Key Insights       Most organisms identified are spread through water & food contamination. Transmission can occur via infectious persons or environmental surfaces. ●       Antimicrobial resistance bacterial strains are hospital-acquired as well as community-acquired community. These drug-resistant strains are circulating among humans, animals & environment in healthcare as well as non-healthcare settings, emphasizing on the need for infection control in both settings. ●       Increasing antibiotic pressure with age and exposure: Fluoroquinolones (Up to the 2nd Gen): The resistance increases across age groups. Adults have more resistance than children. This could be due to irrational use of antibiotics. ●       Older antibiotics such as Aminoglycosides were prescribed less due to prior resistance. This could explain a rise in their sensitivity. Judicious use of Aminoglycosides can be considered.  Key Takeaways   For Clinicians ●       The use of Minimum Inhibitory Concentrations (MIC) is essential. This helps clinicians to choose the right antibiotic with the optimal dose ●       Pseudomonas strains are resistant to most antibiotics. Strict infection control practices are crucial in all OPD & IPD settings. ●       Given the unpredictable resistance patterns of different bacteria, the use of a culture/PCR based assay should be encouraged in all hospital settings. This will help in modifying empirical treatment based on susceptibility obtained. Many PCR assays now provide drug resistance along with identification. ●       About a third of clinically suspected samples showed bacterial growth. This emphasizes the importance of sending samples before initiation of antibiotic. A PCR based method can still detect organisms after the first few doses of antibiotics ●       The primary data indicates a need of laboratory surveillance for Antimicrobial Resistance (AMR). Building on local epidemiology data is important to rationalise antibiotic usage.   For General Public ●       Maintaining hand hygiene is critical for reducing the spread of organisms and thus prevention of AMR. ●       Maintaining better water quality and sanitation can significantly help the cause ●       Fever is not necessarily a sign of a bacterial infection. They can be viral infections which recover without antibiotics. Always seek advice/ prescription of a qualified medical professional before taking antibiotics. ●       Antibiotics prescribed to you should only be taken by you. The same antibiotics shouldn’t be taken by your friends or family without consulting a qualified medical professional. ●       Do not insist on antibiotics if your doctor says you don’t need them. ●       Adhere to the antibiotic dosage prescribed by your doctor. Do not modify its quantity or consumption duration on your own. ●       Always ensure that the medicines you are buying directly from pharmacies, without a prescription, are not antibiotics ]]> https://biospectrumindia.com/news/97/15166/transasia-launches-indias-first-six-plate-elisa-processor-.html https://biospectrumindia.com/news/97/15166/transasia-launches-indias-first-six-plate-elisa-processor-.html Thu, 21 Nov 2019 06:00:00 +0530 The Transasia-Erba group has unveiled Lisa XL, India’s first six plate ELISA processor at the 15th Asia-Pacific Federation for Clinical Biochemistry and Laboratory Medicine Congress (APFCB) being held in Jaipur currently. The device was formally unveiled by Prof. Praveen Sharma, Chairman, Organizing Committee, APFCB Congress, in the presence of Ravi Kaushik, CEO, Transasia Bio-Medicals, Anil Jotwani, Sr. President, Transasia Bio-Medicals and Louis Villar, Commercial Manager, South-East Asia, Erba Group. Designed at Transasia-Erba’s European subsidiary, Lisa XL can perform upto 576 tests at one go, making it a preferred choice for laboratories & blood banks with high workload. Transasia also displayed its entire suite of products in Biochemistry, Urinalysis and Hematology at the conference. The new  instrument is already registered with the Government e-Marketing (GeM) a government digital e-market platform to sell Lisa XL. Commenting on the new equipment, Anil Jotwani, Sr. President, Transasia Bio-Medicals, said, “Today blood banks have to ensure stringent screening with quality instruments and reagent kits. Considering the high volume of testing in India, there is a need to equip blood banks here with the latest technology that enable faster diagnosis without compromising on quality. Also shorter turnaround time also leads to lower cost per test which is important considering pricing is a major factor in India. Microplate processors in India are 1, 2 or 4 plates. By introducing a six plate processor, the first in the country, we are targeting large blood banks.  The new Lisa XL is part of our commitment to making healthcare affordable in India through delivery of world-class diagnostics at competitive prices.” A complete walk-away system, Lisa XL offers a host of features to maximize the efficiency of ELISA processing. Dual probes with powerful robotic engineering allow simultaneous and sequential dispensing of samples in less than 14 minutes and reagents in less than 5 minutes in 96 wells. Lisa XL is in fact the only analyzer in India which processes serum and whole blood simultaneously. For greater accuracy, each microplate has a dedicated temperature controlled incubator with orbital shaking at variable speed, making it the only microplate processor in India with this feature. Further, multiple aspiration and Super Sweep Mode ensures superior washing with minimal residual volume. The new Lisa XL will be highly beneficial in high workload settings for the accurate detection of transfusion transmitted infections like HIV, Hepatitis B, Hepatitis C, Malaria and Syphilis among others which are transmitted through blood. Not just the TTIs, Lisa XL is beneficial to evaluate a wide range of other biochemical markers for Diabetes, Steroid, Inflammatory, Autoimmune disorders, Bone Metabolism, Tumour, Cardiac and anemia markers which can be performed by ELISA in high workload settings. The Erba-Transasia group has been at the forefront of bringing the latest technology from its European subsidiaries and customizing it to meet the needs of the emerging markets. With 15 global subsidiaries the group is fast moving towards its goal of becoming one of the top four companies of the world, offering Total Diagnostic Solutions. It has recently expanded its operations base in Vietnam. Mr. Louis Villar, Commercial Manager, South-East Asia, Erba Group, was a part of the event. Speaking about Erba’s plan for the South East Asian market he added, “We are very excited to be able to serve our customers across South East Asia and support our channel partners from within Vietnam. We have a dedicated team ready to support our customers with application and service expertise as well as sales and marketing.” ]]> https://biospectrumindia.com/news/97/15159/philips-lumify-handheld-ultrasound-supports-life-saving-technology-.html https://biospectrumindia.com/news/97/15159/philips-lumify-handheld-ultrasound-supports-life-saving-technology-.html Wed, 20 Nov 2019 11:10:00 +0530 Physicians from the University of New Mexico (UNM) and local emergency responders recently treated a cardiac arrest patient with the first ever out-of-hospital portable life-support system available in the United States.  The machine performs a function called extracorporeal membrane oxygenation, or ECMO. ECMO machines mimic a functioning heart and lungs, circulating oxygenated blood for patients who have suffered a cardiac arrest.  Until now, ECMO machines have only been available at certain hospitals. But the UNM Department of Emergency Medicine, Divisions of Prehospital Care and Adult Critical Care, in partnership with Albuquerque Fire and Rescue (AFR), deployed the first mobile ECMO program in the U.S.  The machine, which is set up in the back of a specialized ambulance, allows physicians to perform an ECMO procedure in the field. Delivering this level of advanced care in a pre-hospital setting could improve chances of survival by up to 30 percent.  Philips Lumify ultrasound technology is an important component of the mobile ECMO unit. Members of the ECMO team use Lumify for real-time visual guidance when inserting tubes in veins and arteries in a process called ECMO cannulation. “Lumify has excellent image quality and is easy to use – it was instrumental in our first pre-hospital ECMO cannulation,” said Dr. Darren Braude.  Braude, who is the EMS Division Chief and a Professor of Emergency Medicine and Anesthesiology at UNM Health Sciences Center, says that this new, portable ECMO technology offers life support during a crucial, 60-minute window following a heart attack. The AFR-UNM Prehospital ECMO unit is one of many examples that show how point-of-care ultrasound is central to innovation in pre-hospital emergency medicine. While handheld ultrasound has become standard for emergency care within a hospital, moving the technology to a pre-hospital setting reduces the time required to diagnose patients and helps caregivers make crucial decisions about treatment.   ]]> https://biospectrumindia.com/news/97/15116/hcg-opens-speech-and-swallow-lab-for-head-neck-cancer-patients.html https://biospectrumindia.com/news/97/15116/hcg-opens-speech-and-swallow-lab-for-head-neck-cancer-patients.html Fri, 15 Nov 2019 10:00:00 +0530 Bengaluru based HCG, the specialist in cancer care, has officially started a speech & swallow lab, which is an integrated approach for the cancer patients for Head & Neck cancer. A total of Rs 1.3 crore has been invested in establishing this facility. HCG had initiated the lab 2 years back with basic facilities but have now upgraded certain advance features over the last 2 months which is fully functional. The lab comprises of technologies such as Studio kitchen, Taste analysis, Voice and swallow analytics. There is also presence techniques such as of Fiber optic Endoscopic evaluation of swallow (FEES), Video Fluoroscopic Swallow study (VFSS), Digital Cervical Auscultation, PRAAT software for acoustic analysis, Raven Pro software for visual feedback, Narrow Band Imaging – Olympus, Office Video Laryngoscopy, Assistive Swallow devices, Augmentative and alternative communication devices, Diet modifiers / Thickeners, and Low dose laser for mucositis “We plan to start an international journal of speech and swallow. Currently our focus is to advance research in this area. We have 8 projects running in the department focusing on speech and swallow. We will be initiating a collaborative rehab program through the National Cancer Grid that will provide assistance to 140 cancer centers across India aimed to improve the quality of life of these patients. We will shortly be releasing HCG protocols aimed to benchmark national guidelines to direct forced rehab speech and swallow therapy for patients. A international fellowship in speech and swallow rehab is currently underway, using existing fellowship as a yardstick”, said Dr. BS Ajaikumar, Chairman & CEO, HCG enterprises Ltd ]]> https://biospectrumindia.com/news/97/15114/philips-launches-first-clinical-product-for-aiding-cognitive-assessment-.html https://biospectrumindia.com/news/97/15114/philips-launches-first-clinical-product-for-aiding-cognitive-assessment-.html Thu, 14 Nov 2019 14:35:00 +0530 Royal Philips, a global leader in health technology has announced the U.S. debut of its new cognitive assessment platform IntelliSpace Cognition. Leveraging the power of artificial intelligence (AI) and Philips’ cloud-based HealthSuite Digital Platform, IntelliSpace Cognition provides healthcare professionals with a powerful aid for assessing cognitive impairment.    IntelliSpace Cognition automates and enhances well-established neuropsychological tests, offering new insights for clinicians treating patients with debilitating neurological conditions. It provides direct access to detailed information about a patient’s cognition while also providing quantitative longitudinal data to aid in assessing disease progression and treatment efficacy.  “While dealing with the rising tide of neurological disease remains a great challenge, our solution will facilitate robust and reliable cognitive assessment with greater efficiency and scale than traditional methods,” said Jeroen Tas, Chief Innovation & Strategy Officer at Philips. “Combining this with imaging-based diagnostics we aim to offer care providers more meaningful insights into the health of their patients and potentially open up new possibilities for treatment in the future.”  The number of neuropsychologists able to perform an assessment is limited and coupled with a rise in the number of patients suffering from neurological conditions, there is a need for new innovative solutions. A rapid and reliable method for neurologists to better assess cognition and select those that would benefit from seeing a neuropsychologist would alleviate pressure on this part of the healthcare system. Results from a study conducted by Philips support interest in new solutions to address these issues. Ninety-two percent of neurologists indicated that the IntelliSpace Cognition concept would be appealing to use within their practice. Philips has invested in collecting insights from both neurologists and neuropsychologists in order to design IntelliSpace Cognition in an iterative manner and ensure it fits into the majority of existing workflows. IntelliSpace Cognition was developed under a quality management system for medical devices and has undergone rigorous usability testing and a monitored clinical trial has been performed to validate the digital cognitive tests and collect normative data from healthy individuals that reflect the U.S. population. The Philips study found that 80% of neurologists said they would feel confident using IntelliSpace Cognition because Philips has collected normative data to provide peer comparisons to a healthy group. In the typical workflow, illustrated in this video, a patient performs various tests on a tablet under minimal supervision of an assistant with audio prompts to guide in tasks such as drawing a clock, joining numbered dots or remembering a sequence of numbers. The results of the tests are then communicated to IntelliSpace Cognition’s cloud-based computing platform, where advanced validated algorithms perform analytics to present the clinician with the results. IntelliSpace Cognition is just one part of an expanding neurology IT portfolio of Philips which includes, neuroimaging, high density EEG and now digital cognitive assessment.  IntelliSpace Cognition will initially be commercially available only in the U.S.  ]]> https://biospectrumindia.com/news/97/15070/practo-focuses-on-prompt-medical-attention-towards-aqi-severity.html https://biospectrumindia.com/news/97/15070/practo-focuses-on-prompt-medical-attention-towards-aqi-severity.html Fri, 08 Nov 2019 10:00:00 +0530 Post Diwali, the air quality index (AQI) in Delhi breached the “severe plus” mark according to the Centre-run System of Air Quality Forecasting and Research (SAFAR). At a time when the city is crippled with the catastrophic levels of pollution, residents across the city are facing various health concerns ranging from mild fever, cough and cold to severe discomfort, infections. According to a new survey by LocalCircles with over 17,000 respondents from Delhi, 44% Delhi residents said they were having health problems related to pollution, but have not visited a doctor or hospital. Practo insights reveal a 19% increase in online doctor consultations since last week. Most of the patient queries revolved around chest pain, dry cough, hair loss, body aches and fever, skin rashes, to name a few. A large number of queries came in from people in the 21-30 age group bracket. Our insights indicate that there’s an increased need for medical assistance in the capital, but, travel or other barriers with respect to getting in touch with doctors seamlessly, may deter the patients from consulting a qualified doctor. It has also been observed that patients tend to delay their first medical interaction until the condition becomes critical. Practo's initiative is aimed at making Delhiites more proactive about their health and ensuring that no symptom goes undiagnosed. Operating on the principal of early diagnosis that can lead to better health outcomes, Delhiites can use this service 24/7 to get in touch with a qualified doctor instantly, anytime of the day, rather than self-medicating or ignoring it all together. The service will be available for free till 15th November 2019 on Practo app and website. Dr Alexander Kuruvilla, Chief Healthcare Strategy Officer, Practo, said, “The hazardous air quality across the capital has led to a surge in pulmonary, respiratory and dermat diseases. We have made quality doctors available for patients in Delhi over the last week to help people get timely medical assistance. Our team of doctors have indicated that symptoms of these health issues caused by pollution can vary from mild sickness, to severe discomfort, and that it may get difficult for patients to understand whether some of these diseases’ early signs even qualify a doctor visit. Keeping this in mind, we’ve made online consultations with quality doctors available for free for all Delhiites; this would help ensure that patients get a qualified medical opinion and correct line of treatment, without any travel or extra cost. It appears to be one of the worst ever spells of air pollution in Delhi this year, and we are committed to helping Delhiites get in touch with qualified physicians, in a convenient manner.” Dr Prashant Saxena, HOD, Pulmonology and Sleep Medicine, Max Smart Super Speciality Hospital, Saket, said, “There is no doubt that poor air quality poses a great threat to survival. We have seen a rise in the cases both in OPD and emergency due to respiratory ailments. Compromised air quality, both indoors and outdoors, has a direct impact on the health of children, expecting mothers, and senior citizens. There is also an increase in cardiac problems like heart attacks and chest pain etc. Associated allergic problems like nasal discharge/sneezing, headache, eye burning, sore throat etc. have also been observed, especially in children. Moreover, maternal exposure can cause fatal growth retardation, fatal deaths and retarded growth of child post-delivery. Keeping a mask handy, washing eyes frequently with clean water and avoiding outdoor travel during peak hours within the city can help limit exposure to toxic air.” Practo's vision is to make quality healthcare accessible and affordable for a billion Indians, and this initiative is a step in that direction. Over 20 crore patients, or approx. 1 in 7 Indians have received high quality care through the Practo platform in 2019 alone. Working with a team of 1 lakh + doctors, Practo is committed to increasing access to quality healthcare in the country. ]]> https://biospectrumindia.com/news/97/15062/srl-diagnostics-launches-comprehensive-pollution-test-packages-.html https://biospectrumindia.com/news/97/15062/srl-diagnostics-launches-comprehensive-pollution-test-packages-.html Thu, 07 Nov 2019 07:00:00 +0530 Analyzing the rising levels of pollution in Delhi-NCR, SRL Diagnostics has launched Pollution Test Packages to check one’s body’s readiness against the profound threat of pollution. The 4 packages, Pollution Care Basic, Pollution Care Basic+, Pollution Care Advance, and Pollution Care Advance+ have been made available across Delhi-NCR. According to WHO, air pollution can cause diseases like ischemic heart disease, stroke, chronic obstructive pulmonary disease, and acute lower respiratory infections in children. The most obvious advice is to avoid stepping out or indulging in outdoor activities. However, it is also very important to understand how prepared our bodies are to face pollution. Through these tests, one can get a fair idea on the functioning of organs like lung, heart, etc., which have the maximum exposure and are affected the most due to pollution.  The results will indicate how well they will be able to cope up with the alarming pollution levels. The tests are ideal for Individuals with low immunity, allergies, and respiratory disorders and will guide them if they need any further precautions or treatment. Speaking about the need to launch these packages, Arindam Haldar, CEO, SRL Diagnostics said, “We, at SRL Diagnostics, have always been the forerunners in educating our customers to lead a healthy lifestyle. As the air quality in Delhi-NCR has plunged to hazardous levels again and is forecasted to remain severe in the days ahead, a lot of people have started facing severe health issues. It is critical to get yourself tested to find out how prepared are your organs at this time when pollution is at its peak in Delhi-NCR.”  The pollution care BASIC package will include tests like Glucose fasting, CBC, ESR, Vitamin D, Pulmonary function tests, ECG, Serum IgE, etc., whereas the ADVANCE package will include all the BASIC package tests with addition of Creatinine serum, lipid profile, hs-CRP tests and an advanced allergy screening test-Phadiatop.     ]]> https://biospectrumindia.com/news/97/15061/c-camp-to-build-national-rapid-protoyping-facility-for-medtech-startups.html https://biospectrumindia.com/news/97/15061/c-camp-to-build-national-rapid-protoyping-facility-for-medtech-startups.html Wed, 06 Nov 2019 14:55:00 +0530 Bengaluru based Centre for Cellular and Molecular Platforms (C-CAMP) with support from National BioPharma Mission (NBM), BIRAC and DBT, announces a first-of-its-kind national medtech rapid prototyping facility with a focus on Microfluidics technologies. The facility is envisaged to provide design and prototyping support to medtech startups in developing low-cost, rapid and point-of-care Microfluidic Device solutions with applicability in healthcare, both human and animal health. Through this Rapid Prototyping facility, C-CAMP will throw open its doors to researchers from across academia, industry and startups for fabricating plastic microfluidic devices from design to pilot scale bolstered also by basic testing capabilities. The prototyping facility will comprise of a Class 10000 clean room with capabilities for prototyping as well as pilot scale. It is expected that the facility will be launched formally in 2020. ]]> https://biospectrumindia.com/news/97/15058/transasia-erba-group-to-enter-rs-300cr-molecular-diagnostics-space-in-india-.html https://biospectrumindia.com/news/97/15058/transasia-erba-group-to-enter-rs-300cr-molecular-diagnostics-space-in-india-.html Wed, 06 Nov 2019 12:00:00 +0530 Transasia Bio-Medicals Ltd., India’s leading IVD Company has announced that it will soon be foraying into the Rs. 300 crore Indian molecular diagnostics space. It unveiled the MX 16, a fully automated nucleic acid extractor, at the 50th Union World Conference on Lung Health and TB in Hyderabad. The MX 16 has been developed by Erba Molecular, a UK subsidiary of the Transasia-Erba group. The new system will offer an easy-to-use and lower priced molecular TB test in India, with the goal of replacing traditional smear microscopy. The system will be particularly beneficial to India, which has the highest burden of TB and drug-resistant TB: one in four TB patient globally are in India. Also, 89% of affected individuals in India are in the productive age group 15-69, which makes it a critical national health issue to be addressed. Though TB incidence in India has been declining at 1.7% annually since 2016, it is estimated that it needs to fall by 10% annually to reach the Government’s 2025 goal of ending TB in the country. Currently a significant number of TB patients remain undiagnosed for long and out of those diagnosed, only 65% of cases in India are treated. According to the Tuberculosis India Report 2019, there has been a 16% increase in cases compared to 2017, further raising the need for early, simple and accurate diagnostics, which is a crucial element of any successful strategy to address TB in India. To this effect, Molecular testing has been included in first ever Essential Diagnostics List announced in 2018 by the WHO, further stressing the need for timely diagnosis of TB. Announcing the foray, Suresh Vazirani, Chairman & Managing Director, Transasia-Erba International group said, “Erba Molecular in UK is among a handful of companies in the world having state-of-the-art, proprietary molecular diagnostic technology. The unveiling of MX 16 and our upcoming entry into the molecular diagnostics segment in India, is part of our commitment to bringing the best in IVD globally to benefit the Indian public. We have also been careful to ensure the forthcoming MX 16 system offers better sensitivity compared to others in the space, with a target price which is significantly lower, to ensure access to early, accurate TB diagnosis. With 21.5 lakh cases reported in 2018 and many more that remain undiagnosed, I personally think it is the right time for us to introduce our molecular range and we look forward to partnering with the health ministry for a TB- free India.”  In his comments, Dr. Laurence Tisi, President, Erba Molecular, said, “Our technology makes molecular diagnostics less complex and replaces the age-old smear microscopy method for TB detection. With 75% reduction in processing time and the ability to run 16 samples concurrently, MX 16 allows for faster Turnaround Time (TAT). It is fully automated, with a protocol incorporating a unique kill step that enhances lab worker safety during sample preparation. The new solution from Erba will help deliver easy and faster diagnosis, a big benefit in densely populated countries like India.” He further added “We are also planning to bring in Nex-Gen sequencing and other advanced technologies which extracts genetic information from patients and helps to plan treatment needs. The presence of large patient pools suffering from infectious diseases like TB and HIV has created an immense unmet need for superior diagnostic technologies. With current tests prone to delivering false results because of lack of sensitivity, we are working on a comprehensive suite of molecular testing products for other infectious diseases and cancer markers which will use the same MX 16 platform.” Vazirani further added, “Emerging markets like India are the main focus of Transasia-Erba group as they face a higher burden of TB and the challenge of drug resistance. MX 16 being a flexible Molecular platform, we plan to add more menus in the future to make it a comprehensive molecular solution. Our ambitious goal is to offer TB test automation at under US$10. The initial response has been highly promising. The team at Transasia-Erba group is truly proud of developing a solution that directs the power of molecular testing to the increasingly important battle of a TB-free future.” ]]> https://biospectrumindia.com/news/97/15039/find-signs-mou-with-thsti-social-alpha.html https://biospectrumindia.com/news/97/15039/find-signs-mou-with-thsti-social-alpha.html Tue, 05 Nov 2019 11:00:00 +0530 In order to address the diagnostic needs that are critical to enabling universal health coverage (UHC) in India and beyond, the Foundation for Innovative New Diagnostics (FIND) announced that memoranda of understanding (MoUs) have been signed with Social Alpha and the Translational Health Science and Technology Institute (THSTI). The 5-year collaboration with Social Alpha will focus on initiation and scale up of innovative business models and financing mechanisms, including exploration of funding opportunities and mentoring of potential innovators in the development and delivery of market-appropriate diagnostic technologies. THSTI will work with FIND, also over a period of 5 years, to develop point-of-care tests for tuberculosis and hepatitis C, and tools that can identify causes of fever (including malaria) to reduce antibiotic overuse, alongside development of key training programmes. Both agreements were signed during an event held at the 50th Union World Conference on Lung Health in Hyderabad, India, titled In India for the World – accelerating diagnostic R&D and innovation to achieve universal health coverage.  Dr K S Sachdeva, Deputy Director General, Central TB Division, MoHFW; Prof Gagandeep Kang, Executive Director, THSTI; Prof N K Ganguly, Visiting Professor of Eminence, THSTI; Dr Jayeeta Chowdhury, Programme Director at India Health Fund, Social Alpha; Dr Ramanan Laxminarayan, Chair, GARDP Board of Directors; Renuka Gadde, Vice President Global Health, Becton Dickinson; Dr Harish Iyer, India Country Lead, R&D and Senior Scientific Advisor, Bill & Melinda Gates Foundation; Cat Oyler, Vice President Global Public Health, Tuberculosis, Johnson & Johnson; Dr Catharina Boehme, Chief Executive Officer, FIND; Dr Rangarajan Sampath, Chief Scientific Officer, FIND; and Dr Sanjay Sarin, Head of FIND India, among others were part of this event. Speaking at the occasion, Dr Sanjay Sarin, Head of FIND India, said, “We are pleased to partner with Social Alpha and THSTI to spur new diagnostic innovation, which is critical for achieving UHC. With these new partnerships, we aim to leverage the R&D ecosystem in India to accelerate the development and delivery of new diagnostics relevant to the Indian and global context, and strengthen local capacity for diagnostic development.” Manoj Kumar, Founder and CEO, Social Alpha, said, “There is an urgent need to develop innovative technologies to serve the community, and through this collaboration, Social Alpha will work with FIND to develop innovative financing models to drive diagnostic development and delivery in India.” Dr Gagandeep Kang said, “We are excited to partner with FIND and leverage the expertise of the two organizations to drive development of much needed point-of-care diagnostic technologies in areas of mutual interest, and work towards establishing a training programme on diagnostics innovation, development, evaluation and access.” The MoUs are significant in light of the ambitious “Ayushman Bharat” initiative.   ]]> https://biospectrumindia.com/news/97/15040/cook-medical-india-opens-new-facility-in-chennai.html https://biospectrumindia.com/news/97/15040/cook-medical-india-opens-new-facility-in-chennai.html Tue, 05 Nov 2019 07:00:00 +0530 Cook Medical India celebrated its new office opening recently. The company has shifted to a modern, 20,000-square foot office at Kochar Jade in Guindy, Chennai. It is located at the city’s major business district with easy access to land and air freight stations. India is an important part of Cook Medical’s business in the Asia-Pacific region. Cook Medical, which is headquartered in the USA, provides high quality medical devices across the globe. The investment to transform its local facilities into a modern integrated office and warehouse stresses the importance and significance India holds for the future business of Cook Medical. “Our new office in Chennai was designed to be a modernised, best-in-class space to serve both our customers and employees,” said Pete Yonkman, President, Cook Group and Cook Medical during the opening office ceremony. “India is an exciting area for Cook Medical, not only have we had a continuous presence here since 1996, but we have also consistently increased our workforce over the years. This new facility will further enhance our ability to serve patients in India while cementing our commitment to local communities.” The modern, eco-friendly office hosts training facilities with the latest equipment in video conferencing technology and presentation aids that support collaborative learning. This, combined with a state-of-the-art warehouse, promises to provide customer support for faster despatch of products across India. “This new facility will allow us to support our customers better,” said Vijayan Govindaraman, General Manager, Cook India. “We believe that we should always provide solutions, rather than just sell products. The new logistics centre will ensure prompt delivery to our customers.” Maximizing the space and environment was a large part of this office’s design concept. Cook Medical India has made use of natural lighting throughout the new space to reduce its carbon footprint. Govindaraman adds, “The open office encourages employees to collaborate for common outcomes and the exclusive warehouse assures good distribution practices for effective and efficient management of inbound and outbound logistics. Most importantly, it allows us to prioritize the health and wellbeing of our employees.” ]]> https://biospectrumindia.com/news/97/15035/health-minister-lauds-robotic-surgery-facility-at-safdarjung.html https://biospectrumindia.com/news/97/15035/health-minister-lauds-robotic-surgery-facility-at-safdarjung.html Mon, 04 Nov 2019 12:25:00 +0530 The robotic surgery facility in the Safdarjung Hospital (SJH) New Delhi was dedicated to the nation by the Union Minister of Health and Family Welfare Dr Harsh Vardhan. Safdarjang Hospital is one of the biggest tertiary care referral centre of India, under Ministry of Health and Family Welfare catering to all poor patients of uro-oncological cancers like prostate, kidney, bladder cancers and kidney failures, from different parts of country. It is also the first Central Government hospital in India to start this latest Robot Surgery facility for all poor patients for free. Robotic surgery has the advantage of providing minimally invasive surgery, reducing significantly the morbidity & mortality of critically ill, cancer and kidney failure patients. The Robotic system provides 7 degrees of freedom, 3-D vision, 10 times magnification and better dissection with more precision. The operating time also decreases resulting in improvement in turnover of patients and decrease in waiting list of patients for surgery significantly. Already 25 surgeries have been done using robotic system including prostate, kidney, bladder cancers and advanced reconstructive surgeries by Dr Anup Kumar, Head of Department (HOD), Urology and Renal Transplant, SJH and VMMC. SJH has dedicated 21 modular operation theatres, including 24x7 two dedicated renal transplant OTs and a dedicated Robotic OT for Kidney Failure and Urology cancers, for poor patients of India. Dr. Harsh Vardhan said that the Department of Urology and Renal Transplant of SJH has already started the First International LIVE 3-D Laparoscopic Surgeries Web Cast, showing complex uro-oncology and reconstructive surgeries, twice in a month. This has been integrated with the E-Health online education programme of Ministry of Health and Family Welfare which is now connected with 52 Medical colleges across India. This is the first such program in Urology in India. The department is going to start international LIVE webcast of robotic surgeries from the second week of November, 2019. A National Robotic training centre has also been set up for training of young doctors. Union Health Minister congratulated the entire team of SJH headed by Dr Sunil Gupta, Medical Superintendent, SJH for providing this facility free of cost for poor patients. He further said that this is in line with Hon’ble Prime Minister Shri Narendra Modi’s vision of making World class infrastructure and World class expertise accessible to poor Indian population. ]]> https://biospectrumindia.com/news/97/15011/medtronic-launches-new-technology-for-dbs-therapy.html https://biospectrumindia.com/news/97/15011/medtronic-launches-new-technology-for-dbs-therapy.html Thu, 31 Oct 2019 10:55:00 +0530 Medtronic has announced the launch of its advanced Patient Programmer technology for Deep Brain Stimulation (DBS) therapy at the Samsung Developers Conference in the US, held from 29-30 Oct 2019. The new programmer – which received USFDA approval on July 3, 2019 – leverages a user-friendly, custom-configured Samsung mobile device which allows patients to manage their therapy more simply and discreetly. To date, more than 150,000 patients have been implanted with Medtronic DBS devices for management of Parkinson’s symptoms and other conditions. Sandeep Thakkar, D.O., neurologist and movement disorder specialist at Hoag’s Pickup Family Neurosciences Institute said, “It is important for patients to have access to advanced technology for user-friendly therapy management at home. The new Medtronic DBS Activa™ Patient Programmer device is an innovative tool that combines familiar consumer technology with medical devices, which facilitates better control for patients in an easier, more accessible way.“ The Patient Programmer leverages Samsung Knox security technology to help protect the device and patient. The Patient Programmer consists of two components — a programmer handset and a communicator, designed to help patients get the most from their DBS therapy. The programmer utilizes a Samsung smartphone, with a customized, intuitive user interface, on a large 5-inch color touchscreen. The network-connected smartphone and system design lays the foundation for patient data to be shared directly with clinical staff. Clinicians can also define settings and coordinate directly with their patients to adjust DBS therapy settings between clinic visits. The communicator is a separate device that synchronizes with the implanted device and provides a secure connection to the programmer handset. When patients want to adjust physician-prescribed therapy settings, turn therapy on or off, or check the neurostimulator’s battery, they simply hold the communicator over the implanted device and make desired changes using the programmer. Taher Behbehani, head of the Mobile B2B Division, Samsung Electronics America said, “Medtronic’s DBS therapy managed via Samsung devices offers users a blend of safety and control of their data, while also offering elegance and simplicity of use. It’s through our open yet secure mobility platform that we can offer this level of customization on our market-leading devices, and why the world’s leading companies like Medtronic choose to work with us.” Mike Daly, vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic said, “Medtronic has been the leader in DBS therapy for over 25 years. This launch continues to serve as further evidence of our dedication to our DBS patients allowing them to experience an altogether smarter therapeutic journey. The new Patient Programmer builds out an end-to-end solution between patient and healthcare provider with the DBS Clinician Programmer and Activa Programming Application. With this device, patients gain confidence, as they are able to discreetly manage their DBS therapy no matter where they are.” Managed on Samsung Galaxy Tab S2 tablet interface, the Clinician Programmer and Activa Programming Application provides a familiar clinical programming experience, streamlined workflows and actionable information to support neurologists and neurosurgeons in their treatment of patients. Medtronic has partnered with Samsung since 2013 to enhance multiple therapies by integrating Samsung’s user friendly, secure mobile devices into the solution. ]]> https://biospectrumindia.com/news/97/14999/oncostem-completes-validation-study-in-european-cohort.html https://biospectrumindia.com/news/97/14999/oncostem-completes-validation-study-in-european-cohort.html Mon, 28 Oct 2019 14:00:00 +0530 OncoStem Diagnostics, an oncology focused company that enables personalised cancer treatment, has successfully completed its first ever single center, blinded validation study in Europe. The study, conducted in association with Vall d'Hebron Institute of Oncology (VHIO), Spain, involved retrospective validation on a set of 290 patient samples with an accuracy of 96%. The result of this study was on par with the accuracy seen in the previous studies conducted by OncoStem diagnostics. OncoStem’s CanAssist Breast is a prognostic test for early-stage hormone receptor positive breast cancer patients. It makes customized treatment possible by analysing the patients tumor in depth and providing a patient specific report. CanAssist Breast categorizes patients based on the biology of the tumor as either ‘low or high’ risk for cancer recurrence. This clear distinction of patients based on risk of cancer recurrence allows doctors to devise treatment plans that are in tune with the prognosis, maintaining a balance between the benefits and side effects of chemotherapy treatment. Patients who are at low risk of relapse can potentially avoid chemotherapy and its associated side-effects while patients who are at high risk of relapse would benefit from the addition of chemotherapy to their treatment regimen. The retrospective study performed in collaboration with VHIO, Spain was conducted on samples of breast cancer patients ranging in age from 28 to 92 years. The mean age at diagnosis was found to be 61 years and the predominant tumour size was T1 (less than 2cm tumour), in line with previously reported data on Caucasian cohorts. In India, mean age at diagnosis is about 48 years and T2 (2-5 cm tumour) tends to be the predominant tumour size. Despite these differences in the patient profile, the accuracy of CanAssist Breast risk classification in the Caucasian population was found to be the same as what was seen in OncoStem’s Indian studies (96% NPV). This suggests that CanAssist Breast test can be used across all age groups and across a broad range of clinical presentations of early-stage breast cancer. Speaking about the validation, Dr Manjiri Bakre, CEO and Founder, OncoStem Diagnostics said “We are very encouraged by the results of this study as it demonstrates that CanAssist Breast has universal applicability. This validation has taken us a step closer towards our goal to globally validate CanAssist Breast and provide patients with a world class product.” OncoStem Diagnostics presented the validation study data at the recently concluded annual ESMO (European Society for Medical Oncology) Congress 2019 in Europe. ]]> https://biospectrumindia.com/news/97/14987/nathealth-collaborates-with-roche-diagnostics-india.html https://biospectrumindia.com/news/97/14987/nathealth-collaborates-with-roche-diagnostics-india.html Thu, 24 Oct 2019 14:50:00 +0530 In a first for the Indian healthcare industry, NATHEALTH has released its roadmap to enable healthcare access amongst people and patients, with a special focus on diagnostics and preventive medicine. Signing a Memorandum of Understanding (MoU) with Roche Diagnostics India, NATHealth revealed its plans to drive awareness, access and acceptance of digitalization for quality screening, diagnosis and monitoring solutions to reach people across India. Dr. Sudarshan Ballal, President, NATHEALTH said, “The current healthcare scenario in India is unique. We have a fair balance of opportunities and challenges. To explore the full extent of the opportunities before us, there is a need for meaningful partnerships that can establish and sustain a robust healthcare ecosystem that focuses on people / patient understanding and technology in equal measure. I am pleased to announce that we have joined hands with Roche Diagnostic India to provide momentum to our efforts to push policy making that ensures greater access to medical technology and building awareness on the role advanced screening and diagnostic solutions play in reducing the disease burden of the system and the common man. We will be leveraging Roche’s diagnostics capabilities and relationships in India to achieve this objective.”  According to Dr Shravan Subramanyam, Managing Director of Roche Diagnostics India, “It is important that our approach to healthcare development in India addresses some of our immediate needs, while building a foundation of innovation that will help us keep pace with advancing age and evolving disease patterns. I believe that developments in healthcare technology helps us know the condition better and faster, while enabling reach in far flung locations. Our association with NATHEALTH is an affirmation of our focus on establishing the role up-to-date diagnostics solutions can play in enabling quality healthcare, covering medical value and economic benefit.” “We look forward to working closely with Roche Diagnostics India in building awareness on innovations in cancer diagnosis and treatments. Our combined efforts will be aimed at empowering people and patients with the knowledge of diagnostics solutions available, while enabling access to such global technologies in India,” Dr Ballal added.  Over the past six years, NATHEALTH has been focusing on bigger partnerships with public and private healthcare stakeholders, towards supporting the ‘Healthcare for all’ initiatives of the Government. Currently, the Federation is focusing on collaborations to strengthen the five critical pillars of Indian Healthcare namely Ayushman Bharat, Aarogya Bharat (Health as an economic Driver), Preventive Health, Quality & Skilling, Digital Health and Innovation & Entrepreneurship.  ]]> https://biospectrumindia.com/news/97/14972/nureca-joins-hands-with-croma.html https://biospectrumindia.com/news/97/14972/nureca-joins-hands-with-croma.html Wed, 23 Oct 2019 10:00:00 +0530 Nureca becomes the first company to sell healthcare and wellness products from its Dr Trust and Dr Physio brands at Croma stores across India. In a first for the Indian market, Nureca Pvt Ltd has joined hands with Croma, India’s first Omni-channel electronics retailer from the Tata Group, to emerge as the very first company to sell healthcare and wellness products through Croma stores. As part of this tie-up, Nureca will sell products from its Dr Trust and Dr Physio brands at 30 Croma stores across the country. India’s healthcare and wellness landscape is beset by multiple challenges. The country has a vast population, which includes a large number of senior citizens, who now have fewer family members to take care of their medical needs owing to the rising trend towards nuclear families. Furthermore, owing to work-life imbalance and other contributing factors, the incidence of lifestyle disorders and related health issues among working people is on the rise. Home healthcare and wellness technologies can play a crucial role for the geriatric population in preventive healthcare by enabling them to regularly monitor vital health parameters while enabling working people who cannot take out the time to visit clinics on a frequent basis to avail the same facilities at home itself, and that too at affordable prices. Saurabh Goyal, Director, Nureca Pvt Ltd said, “Nowadays, there is a renewed focus on healthcare to be able to better cope with the pressures of fast-paced modern living. Consequently, home healthcare and wellness devices have become more of a necessity rather than a luxury. However, the limited availability of healthcare and wellness devices and the lack of awareness about these products has been a major impediment. Nureca seeks to bridge this gap by making these devices available through the tie-up with Croma.” “Dr Trust’s product range comprises trustworthy medical devices and health monitors, which are backed by pioneering technology. Dr Physio, on the other hand, offers some of the most imaginative and restorative wellbeing and personal healthcare products. While both these brands have a strong presence across e-commerce platforms, the tie-up with Croma will ensure the availability of high-quality yet affordable healthcare and wellness technologies among people who want to physically explore a product before purchasing it”, he added Venu Copal, Head of Buying, Croma, added “We are quite excited to bring forth to our customers the latest in the world of healthcare. When it comes to gadgets, our experience says that customers always prefer to touch-feel-try the product before they buy it. These gadgets being in the healthcare space, is going to make physical validation even more indispensable. As an emerging category in today’s day and age, it’s a great a new addition to our existing portfolio of 9000+ products.”  Under this tie-up with Croma, Nureca will introduce products from these brands at Croma’s ‘Gadgets of Desire’ stores in a phased manner. Apart from meeting Indian standards and regulations like ISO, Dr Trust and Dr Physio products are USFDA and CE approved, which is an endorsement of Nureca’s adherence to the highest quality standards. “The tie-up between Nureca and Croma Retail is an indicator of the upward trajectory and immense potential of this market segment in India. It will go a long way in drawing attention to the need for affordable home healthcare in India and making handy healthcare devices readily available,” said Saurabh Goyal. “Our brands/products, backed by pioneering technology at affordable price points, are designed to help Indian customers keep a check on their health and meet their wellness needs. The Indian market is still at a nascent stage and we want to raise it to a level where customers ask for products which are high on quality and features. As a decisive step in this direction, we have introduced many pioneering features at very affordable price points to give Indian customers access to products which are on a par with global standards,” he added. The medical devices market size, valued at US $4.9 billion in 2017, is expected to go up to US $11 billion by 2022 on account of the rising geriatric population and declining cost of medical services. Besides, technological enhancement and development of medical electronics has made it possible to provide high-quality healthcare at home at affordable prices. It can help patients save 10-25% of the medical treatment costs. The Indian home healthcare market is estimated to reach US $6.21 billion by 2020. Registering a CAGR of 8.8% since 2016 when it was pegged at $220.76 billion, the global home healthcare market is projected to reach $364.69 billion by 2022. The fastest CAGR growth in home healthcare market is expected to come from the Asia-Pacific market, which is expected to grow at 9% from 2016 to 2024. It is projected that in India, where home healthcare adoption is still at a nascent stage, this market will grow from around $4.46 billion in 2018 to $6.21 billion by 2020.    ]]> https://biospectrumindia.com/news/97/14957/veeda-receives-cro-of-the-year-2019-award-by-frost-sullivan.html https://biospectrumindia.com/news/97/14957/veeda-receives-cro-of-the-year-2019-award-by-frost-sullivan.html Mon, 21 Oct 2019 13:10:00 +0530 India Veeda Clinical Research, India’s leading independent CRO, has been awarded as the Indian Clinical Research Organization of the Year 2019 by Frost & Sullivan at India Best Practices Awards held on 16th October 2019 at Hyatt Regency, Mumbai, India. The recipients of the annual Frost & Sullivan India Best Practices Awards were identified based on in-depth research conducted by Frost & Sullivan's analysts. The nominated companies were then evaluated on a variety of actual market performance indicators which include revenue growth; market share and growth in market share; leadership in product innovation; marketing strategy and business development strategy. Over the past several years, Veeda has differentiated itself by delivering innovative, flexible, high-quality, customer-driven solutions to become the leading CRO in India and has a track record for conducting specialized, complex, clinical trial projects. While accepting the award, Mr. Ajay Tandon, Executive Director of Veeda said, "I sincerely thank Frost & Sullivan for nominating us for this award which recognizes the quality of our systems, processes, and people and our continuous effort in nurturing a quality-centric culture. I dedicate this award to our Founders, who from inception, have made quality and ethics the centrepiece of our practices; to our Employees who bring our values to fruition each day; and to our Clients who continuously support and recognize us with repeat opportunities to service them." ]]> https://biospectrumindia.com/news/97/14953/cdsco-notifies-regulation-of-medical-devices-from-december.html https://biospectrumindia.com/news/97/14953/cdsco-notifies-regulation-of-medical-devices-from-december.html Mon, 21 Oct 2019 12:35:00 +0530 Central Drugs Standard Control Organization (CDSCO) has published a gazette notification on recently with the proposal defining all medical devices as drugs and seeking public comments within one month. In a draft notification issued on Friday, the Union Ministry of Health and Family Welfare said, “It plans to define all medical devices, which were earlier not under the purview of the apex drug controller, as drugs under the Drugs and Cosmetics Act from December 1.” As per the notification, Once the final notification is in place, all medical devices including software, equipments, accessories and contraceptives will be regulated under Drugs and Cosmetics Act and firms will have to seek an approval from the the Drugs Controller General of India to manufacture, import and sell any medical devices in the country. Pavan Choudary Director General and Chairman, Medical Technology association of India (MTaI) said, “The Health Ministry's proposal to regulate all medical devices will allow Indian patient the access to quality medical devices also and put a check on garage manufacturing. CDSCO under the Ministry of Health & Family welfare has the most experience and over time have built the expertise to regulate this intricate medical device sector. Bringing all medical devices under regulation has been a long-pending demand from the industry and it is encouraging to see the government taking cognizance of industry concerns." He also added, “The domestic industry would also benefit from this regulatory pathway, as compliance with global standards will open up access to global markets for more domestic manufacturers-and not just the big ones. This Global harmonization (for which a liberal adjustment time is being given), will go a long way in encouraging foreign investments -facilitating Make in India. It will also boost FDI which had recently fallen drastically in this sector.”         ]]> https://biospectrumindia.com/news/97/14942/india-brings-unique-3d-technology-for-spine-surgery.html https://biospectrumindia.com/news/97/14942/india-brings-unique-3d-technology-for-spine-surgery.html Fri, 18 Oct 2019 11:50:00 +0530 On the occasion of World Spine Day, BR Life SSNMC Hospital and Brains Neuro Spine Centre, a leading multi super specialty hospital in the city has launched the Intraoperative 3D Reconstruction Medical Technology for Spine Surgery today. BR Life SSNMC Hospital, located in Raja Rajeshwari Nagar, Bengaluru, has introduced this first-of-its-kind technology in India with an aim to help neurosurgeons in obtaining the sharp image of the spine which can be converted into a 3D image within few minutes. This technology is a boon which will give the surgeons a 360-degree image of the spine orientation with Minimally Invasive Spine Surgery at BR Life SSNMC Hospital was also launched today. BR Life SSNMC Hospital associated with Brains Neuro Spine Center, founded by one of foremost Neurosurgeon, Dr Venkataramana NK has launched - Brains Neuroscience Center of Excellence to provide state-of-the art facility and treatment for all neuroscience and spine related problems. Back muscles support the spine and its strength is critical to prevent back pain. Back muscles bear nearly 60% of the body strain and when they are weak, there is an abnormal stress transference on the bone and discs, leading to tissue damage, back ache and in several cases, spinal injuries. The incidence of spine injuries is on the rise in most of the developing countries. India witnesses more than 2,00,000 cases of spinal injuries a year. Of these, 30,000 relate to spinal cord injury and paralysis of various degrees. Major causes include road accidents (approximately 50%), work place accidents including fall from heights (45%) and sports injuries. Talking about the launch of this new technology, Dr. Venkataramana, Chief Neurosurgeon at BR Life SSNMC – Brains Neuroscience Center of Excellence said, “C-arms technology which we are using currently for spine surgery is an intraoperative X-Ray and imaging technology. In this technology, if the patient is obese or there is any metal interfering, then the image is not shown clearly and can lead to difficulty during the surgery. 3D Reconstruction Medical Technology provides high resolution pictures with sharp images that can be kept and referred to throughout the surgery for reference. With increasing spine problems and surgeries among the young crowd in Bangalore, this technology will benefit the neuro and spine surgeons to analyze the problem and conduct the surgeries with ease and precision.” Commenting on introducing the new technology in BR Life SSNMC Hospital, Col Hemraj Singh Parmar, Group CEO, BR Life said, “At BR Life, we have always taken the initiative to introduce new treatment methods and advanced medical technologies in our hospitals. We aim to provide the best in class treatment to all our patients to ensure that they are well on their path of recovery from all kinds of clinical problems. We are sure that this new technology will benefit the patients in treating them quickly and accurately.” ]]> https://biospectrumindia.com/news/97/14917/lifenet-health-brings-unique-wound-therapy-to-india-.html https://biospectrumindia.com/news/97/14917/lifenet-health-brings-unique-wound-therapy-to-india-.html Wed, 16 Oct 2019 11:05:00 +0530 LifeNet Health's Dermacell AWM®, the world's most-advanced acellular dermal matrix (ADM) for wound treatment, is the first human ADM available in India. This introduction provides access to proven therapy for millions of patients in India suffering from chronic wounds. Each year, as many as 100,000 patients in India face amputation due to a chronic wound. With more than 65 million people with diabetes and 7.5 million new cases diagnosed each year, the incidence of severe wounds and amputation is steadily increasing in India. Dermacell AWM has been shown to effectively treat challenging wounds, thereby reducing the threat of amputation and its debilitating impacts such as decreased quality of life and increased mortality. "We are proud to offer Dermacell AWM as the first therapy of its kind in India," said Rony Thomas, President and CEO of LifeNet Health, a global leader in regenerative medicine. "It's a truly unique clinical solution to help patients overcome severe wounds and avoid the devastating effects of amputation." Dermacell AWM has been utilized as an effective treatment in the U.S., the European Union and Latin America prior to its availability in India. It is supported by multiple studies that show it can bring serious wounds to complete resolution with fewer applications than conventional care or other graft materials.  Dermacell AWM is backed by the technologies and relentless commitment to quality that have made LifeNet Health a global leader in regenerative medicine. LifeNet Health's rigorous screening and production processes ensure the safety and effectiveness of each graft, and patented Matracell® decellularization technology. The result is a wound-treatment solution that offers unsurpassed efficacy with unrivaled safety. LifeNet Health will feature Dermacell AWM at the VSICON Annual Conference Oct. 17-20 in Hyderabad, India.  ]]> https://biospectrumindia.com/news/97/14913/fujifilm-max-healthcare-to-train-doctors-in-advance-diagnostics.html https://biospectrumindia.com/news/97/14913/fujifilm-max-healthcare-to-train-doctors-in-advance-diagnostics.html Tue, 15 Oct 2019 17:20:00 +0530 Max Super Speciality Hospital has announced a partnership with Fujifilm India. Witnessing the scarcity of radiologists and limited experts in breast cancer diagnostics across Asia and in India, the two brands have come together to train doctors in early detection of cancer. Fujifilm will be sponsoring an advanced fellowship in Breast imaging with Max Healthcare Hospital under the guidance of Dr. Bharat Aggarwal, Director - Radiology Services, Max Super Speciality Hospital, Saket and Dr. Harit Chaturvedi, Chairman - Max Institute of Cancer Care. The doctors will be trained in Breast Mammography, Breast MR, and Breast Ultrasound techniques for six months through the Max-Fujifilm Collaboration fellowship program. The program will train two select Radiologists per year towards early detection of Breast Cancer. Commenting on the association, Haruto Iwata, MD, Fujifilm India said, “According to health ministry of India breast cancer ranks as the number one cancer among Indian females with rate as high as 25.8 per 100,000 women and mortality of 12.7 per 100,000 women. We at Fujifilm understand the importance of early detection and are committed at improving the survival rates with advance treatments. Our revolutionary AMULET INNOVALITY is one such product that has made early detection of breast cancer a reality for women all over the world.” “Our association with Max Super Speciality Hospital is a significant and collective step to fight against cancer. With the increasing prevalence of breast cancer in the female populace, it is imperative for healthcare providers to deliver the best and precise early detection screening facilities that can help save lives. We are making continuous attempts to create awareness among women on breast cancer and promoting campaigns such as the Pink Ribbon to encourage the early discovery of breast cancer,” he added. Commenting on the same, Dr Harit Chaturvedi stated, “According to a recent WHO data, it impacts over 2.1 million women each year, and also leads to the highest number of cancer-related deaths among women. There are various factors that might increase the risk of breast cancer in women such as obesity, late or no children, lack of breast feeding, alcohol and smoking. Therefore, women not only need be wary of the key symptoms of the disease such as breast lump, nipple discharge, skin changes over breast, pain in the breast etc. but also closely monitor their regular habits and lifestyle. The most effective tool to win the cancer war in general and breast cancer in particular is awareness and early detection. We recommend annual screening of healthy women above 40 years of age, besides being aware of the symptoms and acting on them. The deployment of this advanced technology in partnership with Fujifilm – Amulet Innovality with 50micronresolution, would play a critical role in screening the healthy population and detecting cancer early and help clinicians deliver more tailored and effective treatment.” Dr Bharat Aggarwal says, “A radiologic exam is an integral part of the diagnosis procedure in the oncology space as it uses radiation or other imaging procedures to find signs of cancer. With increasing occurrence of breast cancer in women, it is imperative to not only raise awareness on the subject but also various modern technologies that have been introduced in the industry to ensure enhanced patient care. The primary goal for our collaboration with Fujifilm is to provide complete and innovative medical attention to breast cancer patients. The new cutting-edge Amulet Innovality with 50micronresolution will play a key role in our battle against breast cancer.” Chander Shekhar Sibal, Executive Vice President & Head of Medical Division at Fujifilm India said, “This partnership is a milestone in the history of healthcare in India, providing highest standards of healthcare at the most affordable cost and optimizing healthcare facilities for the wellbeing of the patients. Early diagnosis has been the biggest draw of our machines and also the fact that they have been designed in a way to ensure that there is minimal pain and discomfort. I am very proud and pleased to share that as of now we have more than 3,500 happy users of our digital mammography across the globe, among them 40 installations are in India. We at Fujifilm believe that such associations and exchange of technology is a critical step forward towards building a vibrant and healthy nation.” This partnership aims at training radiologists for early and effective detection of breast cancer and thereby reduce the breast cancer mortality drastically.   ]]> https://biospectrumindia.com/news/97/14907/siemens-healthineers-uses-new-platform-to-build-effective-ultrasound.html https://biospectrumindia.com/news/97/14907/siemens-healthineers-uses-new-platform-to-build-effective-ultrasound.html Tue, 15 Oct 2019 12:15:00 +0530 Siemens Healthineers has launched the ACUSON Redwood, a new ultrasound system built on the company’s new platform architecture and features advanced applications for greater clinical confidence, AI-powered tools for smart workflows and has shared services cardiology features used by different hospital departments. These features, along with a portable and lightweight design, offer clinicians an affordable and efficient high-performing imaging solution. The ACUSON Redwood’s advanced applications, including Contrast Enhanced Ultrasound (CEUS) and Shear wave Elastography, are available for the first time from the company in this segment and support precise lesion detection and characterization as well as potentially reduces the need for invasive procedures. With a suite of AI-powered tools, the ACUSON Redwood delivers smart workflows for greater efficiency. Designed to go beyond the radiology department and bring precision imaging to more patients, lightweight and portable with 13 transducers, the ACUSON Redwood is easy to move and delivers premium imaging capabilities to the various clinical departments within an organization, such as radiology, cardiology and OB/Gyn. With the ACUSON Redwood, Siemens Healthineers enhances its portfolio of systems built on the new architecture platform, joining the flagship ACUSON Sequoia, and the high-performance ACUSON Juniper. The ACUSON Redwood has 510K clearance from the U.S. Food and Drug Administration (FDA) and European CE mark. ]]> https://biospectrumindia.com/news/97/14887/trs-collaborates-with-bahrains-skype-telemedicine.html https://biospectrumindia.com/news/97/14887/trs-collaborates-with-bahrains-skype-telemedicine.html Fri, 11 Oct 2019 12:40:00 +0530 Bengaluru based Teleradiology Solutions (TRS) have collaborated with Bahrain’s Skype Telemedicine for Remote Radiology Services in Bahrain and Gulf region. More than 200,000 radiologic images across modalities are being processed by Teleradiology Solutions’ International panel of expert radiologists, including UK - FRCR and American Board-certified radiologists, as part of an exclusive long-term agreement with Bahrain-based Skype Telemedicine. The agreement covers remote radiology interpretation services to Bahraini hospitals as well as healthcare facilities from across the Arabian Gulf. Services offered under the TRS – Skype Telemedicine partnership include Teleradiology Services, Nighthawk and Subspecialty Radiology reporting. The services will be delivered using RADSpa®, a teleradiology workflow platform developed and patented by TRS. The RADSpa platform is deployed in 24 countries and has processed more than 20 million studies and billions of images. RADSpa is FDA approved and CE certified. Dr Abdul Rahman Ghareeb, the CEO & Founder, Skype Telemedicine Solutions, said: “TRS is a global leader in teleradiology and we are delighted to join forces with them. This collaboration enables the sharing of their clinical and technical expertise with our expanding client network of hospitals across Bahrain and the wider region. With Teleradiology Solutions as our partners, we are addressing the general shortage of healthcare workers across the region, especially subspecialty radiologists. Hospitals and health systems in the Arabian Gulf region will benefit via access to a robust network of highly qualified U.S.-board certified radiologists and patented teleradiology workflows that are reinforced by a strong local partner presence.”  Dr Arjun Kalyanpur, CEO Teleradiology Solutions said, “There are several new hospital and other clinic projects in the Gulf region. However, there are an insufficient number of trained radiologists. This creates a backlog of radiologic images that need to be interpreted. TRS’s large international panel of radiologists, our ability to deliver 24x7 quality imaging diagnostic services and experience of nearly two decades places us in a strong position to help healthcare partners worldwide develop world-class imaging services. Our partnership with Skype Telemedicine Solutions is improving healthcare utilization, quality and access, while lowering costs.” Teleradiology Solutions has reported scans for over five million patients since inception in 2002, and currently caters to the requirements of 150 hospitals and healthcare centers in more than 20 countries, including the United States, Singapore, Nigeria, Tanzania, Uganda, Maldives and India.    ]]> https://biospectrumindia.com/news/97/14878/supraflex-des-shows-lower-outcomes-against-abbotts-xience-stent.html https://biospectrumindia.com/news/97/14878/supraflex-des-shows-lower-outcomes-against-abbotts-xience-stent.html Thu, 10 Oct 2019 15:30:00 +0530 The ultra-thin Supraflex drug-eluting stent (DES) from SMT maintained numerically lower outcomes at two years of follow-up in a randomized trial against Abbott’s Xience stent, according to results presented at Transcatheter Cardiovascular Therapeutics (TCT) 2019 in San Francisco. Patients who got Supraflex stent in the Talent trial had target lesion failure occur among 6.9% at 720 days (vs 7.9% of Xience recipients), according to a presentation by Dr. Azfar Zaman, Freeman hospital in UK. Dr Patrick Serruys a globally renowned cardiology researcher was the chair for the TALENT trial. The findings of the TALENT trial were presented at the Transcatheter Cardiovascular Therapeutics 2019 (TCT), the largest global conference of cardiologists currently concluded in San Francisco, USA. This study was conducted in 7 countries - United Kingdom, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria - across 23 renowned centres with a sample size of 1435 patients. Xience is regarded as global standard in safety and efficacy for drug eluting stents. Presenting the findings of TALENT trial, Dr A Zaman, UK said, “Safety and efficacy of Supraflex SES with ultra-thin struts and biodegradable polymer were compared with Xience EES in all comers-population. Supraflex was found to be non-inferior to the Xience for DOCE (device-oriented end points) at 24 months in an all comer-population.” Padma Shri Dr Upendra Kaul, one of the leading cardiologists from India was the co-chair of the TALENT Study. Commenting on the study, Dr Kaul said, "There remained a perception that stents produced outside of India were superior to homegrown devices. There were demands from Indian manufacturers to prove that their devices are comparable to those made elsewhere in robust clinical trials.” Prof. R. de Winter, MD, Academisch Medisch Centrum, Amsterdam, The Netherlands; and A. Zaman, MD, Cardiac Catheter Laboratories, Royal Freeman, Newcastle, UK, were the Principal Investigators for the TALENT trial. The individual components of this endpoint suggest that this difference was mainly driven by MI: Target vessel MI: 3.0% vs 3.8% (P=0.382) Cardiac death: 1.3% vs 1.6% (P=0.659) Clinically driven target lesion revascularization: 4.9% vs 5.3% (P=0.718) Over the entire 2-year study period, stent thrombosis rates were similar between Supraflex and Xience groups. However, late and very late instances were more likely with Xience (0.5% vs 1.0%). Supraflex is available in 75 countries across the world and has advanced features like biodegradable polymer and ultrathin strut* (60μm) thickness compared to 81 μm strut thickness and biostable polymer coating of Xience. The TALENT clinical study result matches with the published meta-analysis, highlighting benefits of lower strut thickness.  Piyush Savalia CMO, SMT said, “The result of Talent 2 year data has proved that Supraflex Stent with the best in class features - Ultra thin strut thickness across all diameters, proprietary biodegradable polymers matrix and sirolimus drug is not only as safe as the best in class stent but is numerically better in efficacy in almost all parameters at 2 years. The results from the all comers trial gives confidence to the physicians across the globe and will help in wider adaption.”   TALENT Randomised Clinical Trial (RCT) Medical fraternity views RCT as the highest level of evidence for assessing the quality of a medical product. The TALENT (Thin strut sirolimus-eluting stent in all-comers population vs everolimus eluting stent) trial, involving 1,435 patients, was carried out 1:1 comparing ultra-thin drug eluting stent Supraflex with Xience family of stents from Abbott. The study was conducted at 23 world-renowned centres across seven European countries, including UK, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria. A Randomised Clinical Trial (RCT) ensures that all the bias is removed and there is a fair comparison of two (or more) products. The TALENT RCT study was conducted in real world patient population with very minimal exclusion criteria. The Real world RCT therefore provides evidence that the clinicians would experience in their everyday practice. ]]> https://biospectrumindia.com/news/97/14835/shivani-scientific-wins-historical-case-of-icsi-machines-classification-for-ivf.html https://biospectrumindia.com/news/97/14835/shivani-scientific-wins-historical-case-of-icsi-machines-classification-for-ivf.html Fri, 04 Oct 2019 14:25:00 +0530 Shivani Scientific Industries Pvt. Ltd., a Mumbai based IVF and ICSI technology provider, has won a litigation that now allows classification of ICSI machines, used in IVF and, as medical equipment. The verdict will help reduce the IGST(Integrated Goods and Service Tax) levied on the machines, and the resultant benefits can be passed over to patients, making the IVF and Male infertility treatment cheaper and affordable. The Indian IVF services market is projected to reach $775.9 million by 2022 at a CAGR of 16.6 percent from 2016 to 2022. This is due to the rising infertility rate among Indians. According to statistics, about 10-14 percent of the Indian population is suffering from infertility. Nearly 27.5 million couples are fighting with infertility in the hope of conceiving a child. IVF and other artificial/ assisted pregnancy procedures in India, although in high demand, are also expensive and the sector is loosely regulated. Despite the growth potential, the cost and the inadequate number of clinics, are major challenges that are impacting the sector. The landmark verdict of the litigation fought and won by Shivani Scientific Industries, is helping bridge this challenge. The ICSI Machines, largely used for treating male infertility, consists of Micromanipulator along with Microscope. These, when imported, attracted a higher import duty than other medical devices, and a GST of 18%, as it had been inaccurately classified under the HSN Chapter heading 9011. Considering the wide spread use of these specialised equipment in the field of IVF and Assisted Reproduction   Techniques, M/s. Shivani Scientific Industries contested this classification in a legal battle that prevailed, they pushed forward to get Customs authorities to grant CTH Classification for these equipment them under chapter 9018, along with other medical devices, which enjoy relatively cheaper import duties and a lower GST of 12%. After a persistent legal battle, Shivani Scientific Industries was able to prove the modern usage and significance of Micromanipulator with Microscope, active components of the ICSI machine, as vital medical devices in treatment related to male infertility and was granted a favourable verdict. The order to this effect was passed in March 2019, and has now been received by Shivani Scientific Industries through CESTAT, West Zone, Mumbai. This matter was pursued at various appellate forums for last 5 years and the issue has come to rest when final order was received from CESTAT, Mumbai. The same was accepted and not challenged by the Committee of Commissioner in the Supreme Court. Speaking about the win, Ashish Modi, Director, Shivani Scientific Industries, said, “With growing rate of male infertility in India, there is a rising demand for making appropriate treatment procedures more affordable. The ICSI (Intra Cytoplasmic Sperm Injection), which is performed using ICSI machine, is one of the most impactful treatment for male infertility. There are about 200 ICSI machines that are imported in India every year, mainly from Japan, and they cost around INR 20 Lakhs. The landmark verdict, that followed a 5 year legal battle, would help reduce this cost and make the machine available to hospitals and clinics cheaper by INR 1.0 Lakh. This benefit, when passed on to the patients, can help reduce the cost of the treatment and the overall procedure can now become affordable.” Shivani Scientific Industries have been pioneers in the field of IVF technology, with strong focus on innovation, research, development, and training since 1994. As an industry leader, Shivani Scientific Industries has been leading the way for other players to follow, making its mark as an industry thought leader and proponent of progressive policies in the field. The litigation, which demanded large amount of resources in terms of professional expertise, financial support and dedicated human hours, is one of Shivani Scientific’s many initiatives that showcase its commitment to remain vigilant and drive the growth of the overall industry in India.  The litigation was one of the many pioneering efforts led by Shivani Scientific and it managed this win with the help of their trusted team of professional advisors, senior counsels and its employees. ]]> https://biospectrumindia.com/news/97/14794/abnormal-serum-triglyceride-higher-in-men-than-in-women-srl-diagnostics.html https://biospectrumindia.com/news/97/14794/abnormal-serum-triglyceride-higher-in-men-than-in-women-srl-diagnostics.html Mon, 30 Sep 2019 14:40:00 +0530 SRL Diagnostics has released an analysis of data that it generated from comprehensive coronary risk profile testing, done over the last three years. The analysis was based on 2,487,202 samples of serum triglyceride tests performed at SRL Diagnostics labs across India and revealed that abnormal serum triglyceride was found to be higher in men (65%) than in women (35%). Also, abnormal serum triglyceride was highest in North Zone (54%) compared to all other zones. This analysis was done keeping in view that Cardiovascular diseases (CVD) are increasing globally as well as in India, where the numbers in rural parts of the country are fast catching up with urban, due to oxidative stress arising due to hyperlipidemia, hypertension, diabetes, environmental stress etc. Hypertriglyceridemia is a condition in which triglyceride levels are high. Most often, there are no symptoms of having elevated triglycerides. It is often caused or exacerbated by uncontrolled diabetes, obesity, and sedentary habits.  Elevated triglycerides may contribute to hardening of the arteries and inflammation in the pancreas. This increases the risk of stroke, heart attack, other heart diseases and pancreatitis. Commenting on the research, Dr. B.R. Das, Advisor and Mentor – Research & Development, SRL Diagnostics said, “The burden of cardiovascular disease in India has been rising gradually over the past few decades. Men are at the higher risk of cardiovascular disease due to abnormally high serum triglycerides. Hypertriglyceridemia is not good for health as it increases the risk for coronary artery disease (CAD). Hypertriglyceridemia increases the risk for coronary artery disease (CAD) and hence makes one more prone to associated morbidity. It goes in close association with pre-diabetes most of the times, and is associated with metabolic syndrome - a group of conditions that occur together, viz. increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels. Alongside, obesity and high blood sugar can potentially increase the risk of heart diseases.” CVD is mainly triggered due to the development of fat laden blockages within blood vessels and includes coronary heart disease (heart attacks), cerebrovascular diseases (stroke), raised blood pressure (hypertension), peripheral artery diseases and heart failure.   ]]> https://biospectrumindia.com/news/97/14774/medgenome-unveils-first-diagnostic-lab-for-autoimmune-diseases.html https://biospectrumindia.com/news/97/14774/medgenome-unveils-first-diagnostic-lab-for-autoimmune-diseases.html Thu, 26 Sep 2019 15:05:00 +0530 MedGenome Labs along with Care Hospital Kochi launch IMMUCARE, country’s first exclusive “Autoimmune Disease related Tests and Research based advanced markers Diagnostic Laboratory”. India is home to over 100 autoimmune diseases and is one of the top 10 reasons of death in women and children. Epidemiological data provides an evidence towards steady rise in autoimmune diseases in the past decade which would be responsible for over 14 million cases by 2020 in the country. “Our immune system is a natural layer of protection in our body. However, due to certain genetic defects, our immune system becomes defective leading to what is known as primary immunodeficiency disorders (PID). One consequence of such disorders is susceptibility to infections”, said Dr Padmanabha Shenoy. IMMUCARE would be the only center in our country dedicated to research, diagnostics and analysis of autoimmune diseases. The markers and tests of Autoimmune diseases will be primarily grouped under following specializations: Neurology, Gastroenterology, Hepatology, Nephrology, Rheumatology, Dermatology, Infertility and Allergy. This joint venture aims at providing clinicians accurate, precise and timely diagnosis which will further help reduce adverse effect of autoimmune and associated ailments. “Autoimmune diseases cause substantial chronic morbidity; have a major impact on quality of life, health care utilization, and economic costs; and are associated with increased mortality. There is a huge unmet need for diagnosis as well as research on autoimmune disorders in India. Being a market leader in genetic testing, we have now collaborated with the most reputed Rheumatologist Dr Padmanabha Shenoy to provide our clinicians the best of diagnostics strengths and insights in the domain”, says Sam Santhosh, CEO & Founder MedGenome Labs. Experts opine that genetics along with external factors such as environment, lifestyle and past infections contribute to autoimmune diseases. While the condition may be curable depending on the diseases, for most people controlling the diseases should be the primary goal. Autoimmune diseases lead to chronic illness and has a major impact on the quality of life, healthcare utilization, and economic costs. “This kind of diagnosis is supported with high end technology along with strong expertise of experienced clinicians, pathologists and scientists to address this need in India. At IMMUCARE, all the tests to diagnose and treat autoimmune diseases will be available under one roof”, added Dr Shenoy. IMMUCARE will cater to developing innovative, ground-breaking tests, products and tools to enhance patient care, and transform information into knowledge and insights. The center of excellence has a strong focus on research in autoimmune diseases. “State of the art-technology to perform cell-based analyses, automated ELISA antigen-antibody tests, Immunofixation, blot-based assays, Advanced molecular based systems, genetic tests and Electrophoresis combined with a well experienced and committed team of professionals makes IMMUCARE unique.  IMMUCARE is committed to work with the clinicians for providing them to setup advanced markers for the field of Autoimmunity in our country for the benefit of patients. To support us on this venture, we have a team of medical advisors who are the experts in their respective domains,” says Dr. Aparna Jairam, IMMUCARE Labs. IMMUCARE would be assessing samples from all over the country and will serve clinicians including- Rheumatologists, General Physicians, Pediatricians, Gastroenterologists, Gynecologists, Andrologists, Neurologists, Nephrologists, Psychiatrists, Oncologists, Ophthalmologists, Dermatologists and all faculties in medicine. While located at Kochi the center has a pan India network for quick collection and transportation of samples for timely delivery of reports for patients. ]]> https://biospectrumindia.com/news/97/14728/siemens-healthineers-gets-fda-nod-for-artis-icono-angiography-line.html https://biospectrumindia.com/news/97/14728/siemens-healthineers-gets-fda-nod-for-artis-icono-angiography-line.html Fri, 20 Sep 2019 16:00:00 +0530 The U.S. Food and Drug Administration (FDA) has cleared the ARTIS icono, a high-precision family of angiography systems from Siemens Healthineers that permit a wide range of minimally invasive procedures to be performed in a single interventional suite. The ARTIS icono biplane system is engineered for optimal utilization in neuroradiology and abdominal imaging, while the ARTIS icono floor is a floor-mounted, single-plane system for vascular, interventional cardiology, surgical, and oncology procedures. Both systems in the ARTIS icono family expand the reach of precision medicine. At its core, the ARTIS icono platform delivers the new OPTIQ image chain, which fundamentally redesigns image processing for 2D imaging. OPTIQ increases image quality across a wide range of C-arm angles and patient weights, regulating acquisition parameters to automatically achieve optimal image contrast at patient radiation doses that conform to the As Low As Reasonably Achievable (ALARA) guiding principal for radiation safety. The platform also improves the Siemens Healthineers roadmap function, which creates subtracted angiography images for easier navigation of the patient’s vascular system during subsequent fluoroscopy, allowing dose reduction during the fluoro mode. Additionally, the ARTIS icono platform significantly enhances ease of use through Case Flows, which provide personalized workflow plans to optimize imaging parameters and system positions, in addition to displaying layouts for the entire procedure. Case Flows adapt to user needs, providing flexibility when executing certain sequences. Users can therefore standardize procedures across multiple ARTIS icono labs for improved outcomes and more consistent documentation. “The ARTIS icono family of angiography systems will have nothing short of a revolutionary impact on our customers and on the delivery of healthcare in general, by setting new standards for image quality and optimized workflow in minimally invasive procedures,” says Lara Barghout, Senior Vice President and Head of Advanced Therapies, Siemens Healthineers North America. “And as more hospitals introduce comprehensive stroke services to treat more patients who are eligible for thrombectomies, the ARTIS icono biplane raises the bar in consistent 3D image quality for whole-brain imaging.” ]]> https://biospectrumindia.com/news/97/14717/siemens-healthineers-invests-rs-200m-in-medical-imaging-manufacturing-facility.html https://biospectrumindia.com/news/97/14717/siemens-healthineers-invests-rs-200m-in-medical-imaging-manufacturing-facility.html Fri, 20 Sep 2019 09:00:00 +0530 Technological advances are transforming the healthcare industry globally. As a part of its strategy for India, Siemens Healthineers will integrate manufacturing, technology and innovation functions at Bengaluru. Accordingly, the company has setup a new manufacturing facility that is collocated with its R&D center to better leverage synergies while developing offerings aligned to the future needs of its customers. The Rs 200 million investment in the new manufacturing facility builds on the Rs 25 billion invested in the R&D Center so far, exemplifies company’s enduring commitment to Indi Explaining the strategic significance of the manufacturing facility at the inauguration ceremony on September 19, 2019 in Bengaluru, André Hartung, Executive Vice President Computed Tomography and incoming President Diagnostic Imaging, Siemens Healthineers said, “Collocating a manufacturing facility with our R&D center in Bengaluru marks a significant step in strengthening our presence in India, which is one of our important markets. It also reflects our enduring commitment to India, where we have been enabling better healthcare outcomes for over 90 years, manufacturing medical devices for 60 years, and advancing software excellence for over 25 years.” Gerd Hoefner, Managing Director and President, Siemens Healthcare Pvt. Ltd. added, “As Siemens Healthineers is leading the digitalization of healthcare, the collocation of the manufacturing with R&D center is especially important as it will enable us to deliver value to customers faster. Over the years, the R&D center at Bengaluru, has grown into a digital hub for the company accounting for over half of all the software engineering talent within Siemens Healthineers. It is also the largest such center within the company globally.” Talking about the products that will be made at the new facility, André Hartung said, “The facility will make computed tomography (CT) systems based on our trendsetting Somatom go. platform that we co-created with 500 customers in eleven countries. The new platform combines numerous software-led innovations with our novel detector technologies for radically enhanced workflow efficiency, expanded clinical applicability, improved patient experience, and meeting the financial requirements of healthcare providers.” Talking about the Cios Fit,  Peter Seitz, Executive Vice President Surgery, Siemens Healthineers stated, “Cios Fit, our latest C-arm was created to address the tough demands of India with high patient loads and the need to perform multiple procedures. It offers clear images on a touchscreen monitor, it is simple to use, and has fewer moving parts for higher reliability. We are very proud that the Cios Fit is designed, developed, and manufactured in India for the world.” Operations will start immediately in this new ISO13485 (2016) certified state-of-the-art facility, which is spread across 5000 square meters. ]]> https://biospectrumindia.com/news/97/14689/instaecg-by-tricog-delivers-more-accuracy.html https://biospectrumindia.com/news/97/14689/instaecg-by-tricog-delivers-more-accuracy.html Tue, 17 Sep 2019 15:05:00 +0530 InstaECG was launched by Tricog in 2015 and has so far analysed ECGs (electrocardiogram) for over 23.7 lakh people. It has identified 75000+ critical cardiac cases and 30,540 instances of heart attacks. Tricog’s Insta ECG is proven to be more accurate than a standard ECG machine and takes only 6 to 10 minutes to deliver results. This reduced time frame is crucial as every minute makes a difference in the ‘golden hour’ of emergency cardiac care. The Tricog solution was developed to serve as a bridge between the emergence of symptoms, and the delivery of timely diagnosis and treatment. The idea was to combine the expertise of cardiac physicians with state-of-art IoT technology and advanced AI algorithms, to analyse and deliver results that were both human- and machine-error free. InstaECG enables transmission of ECG data over standard mobile and WiFi networks to the Tricog ECG Cloud. The proprietary algorithms (in the cloud) and the in-house team of cardiac specialists interpret the ECG data and share an analysis report with medical professionals through SMS, Email and Mobile App notifications. Commenting on Tricog’s impact in the Indian market, Dr Charit Bhograj, CEO and Founder, Tricog said, “With InstaECG, Tricog aims to save more lives by providing a system for fast and accurate diagnosis of ECGs, powered by AI and supported by remote cardiac specialists. Our goal is to help fill an important need-gap in India’s emergency cardiac care, especially in ‘health dark’, remote parts of the country.” Since 2015, Tricog has expanded its network to nearly 2000+ ECG diagnosis points in clinics, hospitals and diagnostic centres across India. The data collected from these centres have helped create a virtual store of over 2 million ECGs that cover over 200 cardiac conditions. This ensures that remote centres always have the right diagnosis. In July 2019, Tricog won first place in the ‘Top Innovator’ category at the ET Startup Awards 2019. According to jurors at the event, Tricog had the edge over others in this category because of its ‘advanced technology which can be scaled and marketed to healthcare institutions and doctors.’ Tricog has also won the NASSCOM Artificial Intelligence Game Changer Award 2018 & AI for Good, conducted by the Centre of Excellence – Data Science & Artificial Intelligence (CoE DSAI) in association with the Government of Karnataka. Other awards and accolades include the Accenture Healthtech Innovation Challenge (Regional Finalist 2018), Draper Venture Network for the Most Innovative DVN Company 2018, Fast Company World Changing Ideas Award, 2017 and the EO Entrepreneur of the Year 2015. ]]> https://biospectrumindia.com/news/97/14682/amtz-expands-biomedical-ties-with-australia.html https://biospectrumindia.com/news/97/14682/amtz-expands-biomedical-ties-with-australia.html Tue, 17 Sep 2019 12:05:00 +0530 The University of Wollongong or UOW (NSW, Australia) has signed a strategic collaboration in Visakhapatnam (Vizag), India, bringing its expertise in 3D bioprinting techniques to India’s first integrated medical devices manufacturing zone. AMTZ (Andhra Pradesh Medtech Zone) is India’s first integrated medical devices manufacturing zone being created to provide a one-stop solution covering common scientific, manufacturing and commercial facilities for medical device manufacturers and innovators. Several research and training initiatives will be established under the Memorandum of Understanding (MOU), signed on Tuesday 10 September, 2019. Among the collaborative research initiatives being pursued by AMTZ and UOW is a project to develop a scan and printing package to produce 3D printed ears. This will be coupled with innovative programs to support widespread deployment of the technology in India and Australia. Joint training initiatives will primarily focus on 3D biofabrication. TRICEP - UOWs Translational Research Initiative for Cellular Engineering and Printing - will provide critical input into both research and training initiatives. TRICEP houses world-leading research infrastructure to develop innovative technologies in 3D bioprinting, including printer manufacturing, biomaterials, and bioinks. ]]> https://biospectrumindia.com/news/97/14678/ge-healthcare-receives-fda-approval-for-ai-algorithm-on-x-ray.html https://biospectrumindia.com/news/97/14678/ge-healthcare-receives-fda-approval-for-ai-algorithm-on-x-ray.html Mon, 16 Sep 2019 15:00:00 +0530 GE Healthcare has announced the Food and Drug Administration’s 510(k) clearance of Critical Care Suite, an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF), using GE Healthcare’s Edison platform, the AI algorithms help to reduce the turn-around time it can take for radiologists to review a suspected pneumothorax, a type of collapsed lung. A prioritized “STAT” X-ray can sit waiting for up to eight hours for a radiologist’s review. However, when a patient is scanned on a device with Critical Care Suite, the system automatically analyzes the images by simultaneously searching for a pneumothorax. If a pneumothorax is suspected, an alert – along with the original chest X-ray – is sent directly to the radiologist for review via picture archiving and communication systems (PACS). The technologist also receives a subsequent on-device notification2 to give awareness of the prioritized cases. Quality-focused AI algorithms simultaneously analyze and flag protocol and field of view errors as well as auto rotate the images on-device. Critical Care Suite and the quality algorithms were developed using GE Healthcare’s Edison platform – which helps deploy AI algorithms quickly and securely – and deployed on the company’s Optima XR240amx system. Additionally, embedding Critical Care Suite on-device offers several benefits to radiologists and technologists. For critical findings, GE Healthcare’s algorithms are a fast and reliable way to ensure AI results are generated within seconds of image acquisition, without any dependency on connectivity or transfer speeds to produce the AI results. These results are then sent to the radiologist at the same time that the device sends the original diagnostic image, ensuring no additional processing delay. Also, automatically running quality checks on-device integrates them into the technologist’s standard workflow and enables technologist actions – such as rejections or reprocessing – to occur at the patient’s bedside and before the images are sent to PACS. ]]> https://biospectrumindia.com/news/97/14654/remido-deivce-shows-promising-results-for-diagnosing-diabetic-retinopathy.html https://biospectrumindia.com/news/97/14654/remido-deivce-shows-promising-results-for-diagnosing-diabetic-retinopathy.html Wed, 11 Sep 2019 14:55:00 +0530 Diabetic Retinopathy (DR), is asymptomatic and affects nearly 20% of the 70 million diabetic patients in India. Timely and accessible DR screening can enable early detection, preventing needless blindness. Nearly 70% of the population, especially those in rural areas lack access to specialists, given the very low specialist to population ratio of 1:100000 in some areas.  A landmark study published in the August issue of JAMA Ophthalmology (Journal of the American Medical Association), reports the feasibility of using a smartphone-based retinal camera with the world's first, in-built automated, offline Artificial Intelligence (AI) algorithm, the MEDIOS-AI, designed by Bangalore-based Remidio Innovative Solutions, to implement sensitive and scalable screening models for DR.   A team from Aditya Jyot Foundation for Twinkling Little Eyes, Mumbai, led by Dr. Natarajan, President of the All India Ophthalmology Society, has till date screened more than 1300 patients with diabetes mellitus in civic dispensaries in Mumbai for DR and validated the diagnostic accuracy of MEDIOS-AI to detect Referable DR, a condition requiring immediate specialist consult. The AI instantly provides a report in less than 10 seconds, on the smartphone.  Florian Savoy (VP, Data Sciences & AI) and Bhargav Sosale (VP, Software Design), the architects of Remidio’s smartphone-based AI solution, suggest that the novel, offline AI platform is "extendable to Glaucoma, AMD and other sight-threatening chronic diseases".  The images were captured on Remidio’s smartphone-based, non-mydriatic, portable camera, the NM-FOP 10 and subjected to automated analysis by MEDIOS-AI, with simultaneous grading by vitreoretinal specialists. MEDIOS-AI relied on 2 convolutional neural networks, based on the MobileNet architecture - one assessing the image quality, and the other separating healthy images from images with referable DR (RDR). The clinical sensitivity and specificity of the MEDIOS-AI algorithm were found to be 100% and 88.4% for RDR, 85.2% and 92.0% for any DR respectively, exceeding US FDA’s superiority endpoints of an RDR sensitivity of 85% and specificity of 82.5%.  Dr. T.Y. Alvin Liu, MD, Assistant Professor of Ophthalmology at Johns Hopkins Bloomberg School of Public Health, in an invited commentary, calls the study "paradigm-shifting”.  Dr. Natarajan, MD opines, “The study paves the way in implementing large scale models for screening for DR, even in locations with no internet infrastructure. This is a step ahead of the approach taken by Google and other AI companies that need their AI models to run on external servers, necessitating internet access.”  Dr. Anand Sivaraman, CEO, Remidio, believes that "technologies like Remidio NMFOP & Medios Offline AI, are necessary to move screening closer to the nearly 400 million patients at risk of blindness globally, due to chronic, asymptomatic conditions like Diabetic Retinopathy". ]]> https://biospectrumindia.com/news/97/14625/abbott-unveils-worlds-first-triluminate-pivotal-trial-.html https://biospectrumindia.com/news/97/14625/abbott-unveils-worlds-first-triluminate-pivotal-trial-.html Mon, 09 Sep 2019 09:00:00 +0530 Abbott has announced the launch of the company's TRILUMINATE Pivotal trial to evaluate the safety and effectiveness of the company's TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). This is the first pivotal Investigational Device Exemption (IDE) trial in the U.S. to evaluate a catheter-based, non-surgical treatment for patients with severe TR – a condition in which the valve doesn't close properly, allowing blood to flow backward into the heart, which forces the heart to work harder. In severe cases, this condition can potentially lead to heart failure if left untreated. The first enrollments in the TRILUMINATE IDE study occurred at Abbott Northwestern hospital in Minneapolis, Minn., led by Paul Sorajja, M.D., and his cardiac team. Dr. Sorajja also serves as the trial co-primary investigator. "Patients with symptomatic tricuspid regurgitation are often at an increased risk for conventional surgery. As a result, many are not referred for intervention," said David Adams, M.D., Chairman of the Department of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai and the Cardiac Surgeon-in-Chief of the Mount Sinai Health System and co-primary investigator in the trial. "The opportunity to assess how we can better treat these patients with a minimally invasive approach is critical and we’re excited about the potential for this therapy in improving the quality of life for these patients." The TRILUMINATE Pivotal study is a prospective, multi-center, randomized, controlled global study of approximately 700 patients expected to enroll in the United States, Canada, and Europe. Patients will be randomized to receive either the TriClip device or medical therapy and followed for a total of five years. The study will also have a single arm for the treatment of subjects with more complex tricuspid valve disease. Alongside the TRILUMINATE study, Abbott's TriClip device was accepted for national reimbursement consideration through a process known as "Parallel Review" by the FDA and the Centers for Medicare and Medicaid Services (CMS). The Parallel Review program is a collaborative effort that is intended to reduce the time between FDA approval and Medicare coverage decisions through CMS's National Coverage Determination (NCD) process. The launch of the TRILUMINATE Pivotal IDE study follows a smaller, single-arm TRILUMINATE trial that was conducted in Europe and the U.S. to evaluate the safety and performance of the TriClip repair system. Results from that study, presented during a late-breaking session at EuroPCR 2019, found that after 30 days, 86.6 percent of patients who received the TriClip device saw a reduction in TR severity of at least one grade. In addition to a strong safety profile for the procedures in patients considered to be at high risk for surgery, a significant proportion of patients also saw an improvement in their heart failure symptoms as assessed using the New York Heart Association (NYHA) functional classification and Kansas City Cardiomyopathy Questionnaire (KCCQ) score. Abbott's transcatheter tricuspid valve repair system is an investigational device only. The TriClip valve repair system is built on the foundation of Abbott's MitraClip system, which has been commercially available in the U.S. since 2013 and in Europe since 2008. With more than 15 years of clinical experience and over 80,000 patients treated worldwide, the MitraClip system is the first and only transcatheter mitral valve therapy with proven safety and survival, and durable clinical outcomes. ]]> https://biospectrumindia.com/news/97/14633/robotic-surgery-advancing-assistance.html https://biospectrumindia.com/news/97/14633/robotic-surgery-advancing-assistance.html Sat, 07 Sep 2019 16:50:00 +0530 The extent to which robotic surgery has been embraced by the surgical fraternity has been unparalleled. Robotic surgery, or robot-assisted surgery, allows doctors to perform many types of complex procedures with more precision, flexibility and control than is possible with conventional techniques. The first documented use of a robot-assisted surgery occurred in 1985 for a delicate neurosurgical biopsy, a non-laparoscopic surgery. Later on in 2000, the Da Vinci Surgery System broke new ground by becoming the first robotic surgery system approved by the FDA for general laparoscopic surgery. The Da Vinci Surgical System is a robotic surgical system made by the American company Intuitive Surgical. Intuitive was founded in 1995 to create a future where minimally invasive care that would enable surgeons, their OR teams and healthcare systems to help take care of their patients. Launched in 1999, the Da Vinci surgical system is a surgical platform designed to enable complex surgery using a minimally invasive approach. Da Vinci systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. There are several models of the Da Vinci surgical system, including the Da Vinci Xi® System, the company’s flagship offering and the more recently launched Da Vinci® X that features cost-conscious options but with the same arm architecture as the Da Vinci Xi®. The Da Vinci SP® system is a single-port access system for control in narrow surgical spaces. With 24 years of driving minimally invasive innovation, Intuitive has completed around 6,000,000 minimally invasive surgeries in the areas of urology, gynecology, colorectal, cardiac, thoracic and general surgery with the help of more than 40,000 da Vinci surgeons globally and approximately 5800 employees worldwide. Present in Switzerland, US, Germany, Mexico, Japan, Korea and Taiwan, Intuitive established a direct presence in India in 2018 at Bengaluru. Although, the first da Vinci robotic assisted surgery took place in India nearly two decades ago in a Delhi hospital in 2002.    Currently, Intuitive has two training centres in India- Amrita Institute of Medical Sciences and Research Centre, Kochi and M.S. Ramaiah Medical College, Bengaluru. “We aim to provide best-in-class training and support for surgeons here in India throughout their careers, from initial exposure to and learning how to use the technology, to progressing through more advanced training. Of particular importance to us here in India but also Intuitive more broadly is not merely introducing the technology, our robotic-assisted surgical system, but assuring that we can support our customers in establishing strong robotics programs through everything that supports the technology: training, customer service and support”, shares Mandeep Singh Kumar, Vice President and General Manager, India. In the first half of 2019, the growth of Da Vinci procedure was recorded at 17 per cent in comparison to the first half of 2018. The base installation of Da Vinci has grown by 13 per cent this year. The company has also received FDA approval for Da Vinci SP for transoral surgery indication (Available in US & Korea); and Ion endoluminal system to enable minimally invasive biopsy in the peripheral lung (Available in US). The global surgical robots market is projected to register a healthy CAGR of 14.1% in the forecast period of 2019 to 2026. The future of robots-assisted surgery is nearly as promising as the humans are inventing the better ways of accomplishing the delicate medical procedures. The rising ageing population, rising case of acute and chronic diseases and better benefits to patients and surgeons will gradually become the main drivers for global surgical robots market.   ]]> https://biospectrumindia.com/news/97/14627/neuberg-bets-big-on-superior-diagnostic-experience.html https://biospectrumindia.com/news/97/14627/neuberg-bets-big-on-superior-diagnostic-experience.html Fri, 06 Sep 2019 16:00:00 +0530 Neuberg Diagnostics Private Limited, the fastest growing healthcare start-up in India which ranks among the top 4 diagnostic service providers in the country, has announced the launch of Anywhere Anytime services - a first in the diagnostics lab chain space. The full-fledged sample collection and ECG services will be offered in Chennai, Bangalore, Cochin and Hyderabad. As part of the offering, samples can now be collected from any location that is convenient for an individual, subject to the place maintaining basic standards of hygiene and privacy. As a launch offer, the Anywhere Anytime services will be offered free of cost. The service would be catered to by Neuberg’s own, in-house trained phlebotomists. The core thought behind Neuberg launching Anywhere Anytime is to make the diagnostics tests (blood, urine and ECG) accessible and affordable to the public 24x7. The company also announced the merging of Healyst Laboratory with Neuberg Ehrlich, by virtue of which Healyst will now be part of Neuberg Ehrlich Laboratory Private Limited. Dr. P. Srinivasan and Dr. Saranya Narayan have been inducted into Neuberg Ehrlich Laboratory’s leadership team. Dr. Srinivasan will take over as Technical Director, while Dr. Saranya will assume the role of Technical Director & Chief Microbiologist. Confirming the developments, Mr. A. Ganesan, Director – Finance, Neuberg Diagnostics Private Limited said, “Neuberg has always aimed to lead the movement towards early and accurate diagnosis; and to deliver deep insights by making state-of-the-art technology and new generation diagnostics accessible and affordable to people…thus enabling better quality of life. The launch of Anywhere Anytime services and the coming in of Dr. Srinivasan and Dr. Saranya, who are proven experts in the diagnostics space, are in line with this endeavour. Today is undoubtedly a red-letter day in the history of Neuberg, where we have the Co-Founder of Metropolis; Co-Founders of Lister Laboratory and Healyst Laboratory; and the Ehrlich founding family coming together to offer the best in class Reference Path Lab services in Tamil Nadu and Pondicherry.” Commenting on his and Dr. Saranya’s appointment, Dr. Srinivasan says, “Neuberg has tremendous potential in the diagnostics space today. Dr. Saranya and I are honoured and overwhelmed to be part of this dynamic organisation promoted by none other than Dr. G. S. K. Velu, a name that needs no introduction in the healthcare industry. We look forward to closely working with the entire team in realising Neuberg Diagnostics’ vision and mission. Our primary focus will be to grow Neuberg Ehrlich to a strong position in the region and to model the desired changes for further growth and expansion.” “While convenience is an important factor that drives the diagnostics space, equally important is the accuracy and speed of obtaining a report on the tests provided. People are growing more aware of the importance of their own health and wellbeing and are increasingly expecting and demanding more personalised healthcare. Neuberg firmly believes that a service like Anytime Anywhere can bring about a transformation in India’s healthcare segment by putting power in the hands of individuals, and saving them valuable time and money,” adds Dr. Saranya. Quality is the foundation on which Neuberg Ehrlich is built. With a CAP and NABL certification, one can be assured of world class standards and globally accepted reports. The laboratory processes are subject to periodic audits from external and internal assessors. The stringent control on processes through well documented SOPs enhances laboratory functions, staff confidence and results in enhanced customer confidence and satisfaction. Neuberg Ehrlich Laboratory’s capabilities include Biochemistry, Microbiology, Hematology, Histopatology, Molecular Biology, Genomics, Personalised Medicine, Metabolomics, Proteomics and New Born Screening (NBS). Neuberg Ehrlich Laboratory, a Regional Reference Lab, presently has 10 clinical labs in Tamil Nadu, which are located in Chennai (3), Trichy (2), Salem (3), Hosur (1) and Karaikudi (1). 10 more labs will soon be coming up in the cities of Tanjore, Madurai, Coimbatore, Tirunelveli and Nagercoil. Also presently 50 collection points are operational and 50 more will be made operational within 3 months. Neuberg Ehrlich Laboratory is one of the approved private diagnostics centers for H1N1 testing by the Government of Tamil Nadu. Neuberg Ehrlich Laboratory is also running an NABL accredited New Born Screening Laboratory at ICH, Egmore Chennai on PPP model. ]]> https://biospectrumindia.com/news/97/14582/transasia-erba-group-sets-a-new-benchmark-.html https://biospectrumindia.com/news/97/14582/transasia-erba-group-sets-a-new-benchmark-.html Tue, 03 Sep 2019 10:55:00 +0530 Transasia Bio-Medicals Ltd. has announced that it has successfully sold over 1,000 units of the recently launched Erba hematology range of analyzers in India, thereby retaining its No. 1 position in the Indian hematology market. Transasia is India’s leading In-vitro Diagnostic Industry and a part of the global Transasia-Erba group. A result of in-depth research and development at the group’s European centre, the Erba hematology range was launched in India just four and half months ago to mark Transasia’s 40th anniversary. The 3-Part (H 360) and 5- Part (H 560 and ELite 580) fully automated hematology analyzers, reagents and controls include a number of features to help institutions, clinicians and laboratory technologists offer accurate diagnosis. When asked what he felt about this remarkable feat, Mr. Suresh Vazirani, Chairman & Managing Director said, “All along the 40 years of our journey, we have been committed to offering the highest level of quality and service to Doctors and their patients. India’s greatest need is the easy access to affordable healthcare. And that is the lacunae that we have been striving to fill by pooling in our best technologies from our global subsidiaries and making them available at affordable prices for Indian hospitals and labs.” “Our Erba range of hematology analyzers is comparable to the best in the world and is widely used in the European market. I am grateful to our customers for their overwhelming response and our success is an outcome of the trust they bestow in us”, he further added. Erba H 360 is a 3-Part Differential Hematology analyzer and is suitable for obtaining a complete blood count (CBC) with a three part differential white blood cell (WBC) count. On the other hand, the 5-Part Differential analyzers, H 560 and Elite 580 measure cell morphology and detect small cell populations to diagnose rare blood conditions. All the three instruments are designed to be user-friendly and convenient. They aid in the screening of hemoglobinopathies like Thalassemia, sickle cell anemia and other hemoglobinopathies that are prevalent in India.   With more than 65,000 installations and the largest sales and service team in the Indian IVD Industry, Transasia has been living upto its aim of quality, accessible and affordable diagnostic solutions. Globally, the Transasia-Erba group with 14 subsidiaries across USA and Europe, is serving more than millions in over 100 countries and is dedicated to offering affordable solutions for the emerging markets. ]]> https://biospectrumindia.com/news/97/14562/portea-medical-launches-incontrol-for-diabetes.html https://biospectrumindia.com/news/97/14562/portea-medical-launches-incontrol-for-diabetes.html Thu, 29 Aug 2019 10:20:00 +0530 Portea Medical, consumer healthcare brand, recently launched InControl, a one-of-its-kind complete diabetes care program for patients with Type 2 Diabetes. The Portea InControl program puts in place a comprehensive diabetes care plan, provides necessary equipment for monitoring and offers one-on-one health coaching. In India, about 50.9 million people suffer from diabetes, and this figure is likely to go up to 80 million by 2025, making it the 'Diabetes Capital' of the world. This combined with increasing financial and professional stress on the patients makes most of them neglect their health even after being diagnosed with the condition. The major reasons for this neglect include lack of time, lack of credible information sources, poor access to Diabetologists and overall ignorance about the long term impact of the disease. Portea InControl aims to address all these barriers. With an annual subscription, a patient will get a free glucometer, unlimited supply of test strips, and above all, the right health coaching through a certified counsellor for a period of one year. Speaking about this, Meena Ganesh, Co-Founder and CEO, Portea, said, “As India’s largest home healthcare company, we are responsible for leading the chronic disease management in the country. Given our six-year experience in this domain, we understand that right monitoring and self-disciplined lifestyle can bring about improvements in people with Type 2 diabetes. Portea InControl program is unique program that will bring together Diabetologists and nutrition counsellors to a tech platform where they can remotely monitor patients’ conditions and work with patients to bring about positive health outcomes. We are targeting to help at least 50,000 patients in the first year of launch.” The InControl program stems from Portea’s belief that management of diabetes does not require a herculean effort but rather a regular, step by step approach, towards self-discipline. By combining two important parameters -- regular monitoring and health coaching – the program aims to help people in complying with their treatment regimen and manage their condition better. It will also help in detecting early signs of co-morbid conditions. The subscription to InControl costs INR 1999 for an year, which includes OneTouch Verio Flex Glucometer; Free test strips for the entire year and personalized health coaching.   ]]> https://biospectrumindia.com/news/97/14531/philips-unveils-philips-2019-future-health-index-report.html https://biospectrumindia.com/news/97/14531/philips-unveils-philips-2019-future-health-index-report.html Mon, 26 Aug 2019 12:50:00 +0530 Philips, a global leader in health technology has unveiled the India findings of its 15-country Future Health Index (FHI) 2019 report: ‘Transforming healthcare experiences: Exploring the impact of digital health technology on healthcare professionals and patients’. The study reveals that India is a forerunner in the adoption of digital health technology with 76% of healthcare professionals in the country already using digital health records (DHRs) in their practice. Interestingly, India meets the 15-country average when it comes to the usage of AI within healthcare at 46%. Commenting on the launch, Rohit Sathe, President – Philips Healthcare, Indian Subcontinent said, "Philips’ Future Health Index 2019 report confirms that digital health technology is a pivotal pillar in delivering value-based care across the healthcare continuum in India. Tools including telehealth and adaptive intelligence (AI) solutions can help lower the barriers between hospitals and patients, thereby improving access to care and enhancing overall patient satisfaction, particularity in tier II & III cities in India.  We hope that the insights from this report will assist key stakeholders in designing and implementing robust and sustainable health systems in the country.” KEY FINDINGS OF INDIA FUTURE HEALTH INDEX 2019 More healthcare professionals are using digital health technology in India For some of the key technologies examined, India is on par with the 15-country average – particularly digital health record (DHR) adoption and use of AI technologies 80% of healthcare professionals in India have shared patient information with other professionals inside their health facility, which is equal to the number of healthcare professionals who share patient information electronically across the 15-country average 76% of Indian healthcare professionals and healthcare professionals in the 15-country average are using digital health records (DHRs) in their hospital/ practice 46% in India use AI technologies within their healthcare practice and even more would be comfortable, regardless of whether they are currently using it, for: staffing and patient scheduling, 76% vs. 64% of healthcare professionals in the 15-country average patient monitoring, 74% vs. 63% of healthcare professionals in the 15-country average recommending treatment plans, 63% vs. 47% of healthcare professionals in the 15-country average diagnosis, 67% vs. 47% of healthcare professionals in the 15-country average Individuals in India are likely not worried that AI will substitute the human aspects of their healthcare experience, as only one in five (19%) associate AI with less human interaction compared to one-in-three (31%) individuals living within the 15-country average.   When Indian healthcare professionals are supported by digital technology, their experience improves A majority of Indian healthcare professionals who use DHRs in their practice report that DHRs have a positive impact on quality of care (90%), healthcare professional satisfaction (89%), and patient outcomes (70%) when compared to the 15-country average of 69%, 64% and 59% respectively 64% of Indian healthcare professionals agree that patients having access to their own health data (including test results, prescriptions, scans etc.) has positively impacted their patients’ experience. 87% of Indians with access to their digital health record say they want their healthcare professionals to have access as well Encouraging broader use of telehealth is needed in India to revolutionize healthcare About two-thirds (67%) of Indians feel comfortable or neutral about seeking medical advice from their doctor through a health application on their phone, suggesting a high willingness and openness to further adopt telehealth and unlock its benefits. About half (49%) of Indians say they know nothing at all about the benefits of digital health technology or mobile health apps in healthcare. Providing education and information around the benefits of these technologies will be key in taking Indians along this technological healthcare journey. The report reflects independent research, commissioned by Philips in 15 countries, in which India was included. It is based on the assessment of care delivery against the Quadruple Aim (better patient outcomes, improved patient experience, improved staff satisfaction, and a lower cost of care) with a focus to build sustainable healthcare systems. ]]> https://biospectrumindia.com/news/97/14510/blk-super-specialty-hospital-introduces-south-asias-most-advanced-mri.html https://biospectrumindia.com/news/97/14510/blk-super-specialty-hospital-introduces-south-asias-most-advanced-mri.html Fri, 23 Aug 2019 09:00:00 +0530 New Delhi based BLK Super Specialty Hospital has introduced South Asia’s First Signa Artist Wide Bore 96 Channel Digital MRI system. This most advanced technology delivers a new level of clinical performance with additional research-focused capabilities, especially for Neurology, Cardiology, Orthopaedics and Oncology.  The state of the art new MRI system with wide bore helps ease anxiety concerns with tight spaces and reduces claustrophobia.  This machine can scan any body part going head or feet first. This works wonder in reducing patient anxiety. Feet first scanning is available for all body parts and that helps in making the procedure less claustrophobic for many patients. Dr. Prem Kumar Ganesan– Director & HOD, Radiology and Imaging, BLK Super Speciality Hospital said, “From the patients perspective this advanced machine significantly reduces scan time. A brain scan with Magic sequence can be done in five minutes which would have otherwise taken at least 20 minutes. “As a standard biomarker in oncology diffusion imaging plays a critical role in cancer detection and staging, the whole body diffusion can be done in 20 minutes which is a major achievement also SIGNA Artist uses intelligent quantitative solutions to automatically detect and correct distortion, artefacts and motion.”  “The spatial and temporal resolution of Signa Artist is amazing providing much clearer and sharper images there by increasing the confidence of the radiologist in making correct and accurate  diagnosis” added Dr Prem Ganesan. Announcing the launch, Dr. Sanjay Mehta, Head, Medical Services, BLK Super Specialty Hospital said, “Over the years, we have been adopting new components of people, process and technology in our model to emerge in the new healthcare ecosystem. The need of the hour is to provide high-quality clinical outcomes to match the growing demand for quality healthcare in the country. We are adopting new technologies which are purely for clinical use. Newer X-rays, MRI, Robots, Radiation or Minimal invasive surgeries etc are technologies which enhance clinical outcomes. With the launch of the most advanced MRI system, the Hospital reinforces its commitment to provide the best-in-class services to the people.” The New System offers multiple startling advances in imaging with Tractography and advanced Functional Imaging.   Another unique feature is the reduction of noise inside the MRI machine.  The quieter machine and the new in bore experience which  allows the patients to choose  music and videos of their choice to be viewed during scan makes the overall patient experience much more enjoyable and allows the  technicians to smoothly  and  efficiently complete the scan.   ]]> https://biospectrumindia.com/news/97/14470/iit-chennai-to-organize-cahotech-2019.html https://biospectrumindia.com/news/97/14470/iit-chennai-to-organize-cahotech-2019.html Tue, 20 Aug 2019 10:00:00 +0530 Technology has started to play an important part in our lives and healthcare is no exception. Technology is disrupting the healthcare delivery very rapidly and CAHOTECH has become the platform for healthcare providers to learn about the recent advances and also to make them ready for futuristic trends in the field of IT, medical equipment, machinery, processes. CAHOTECH also aims to develop a healthy and positive relationship between technology developers, innovators and stakeholders in healthcare delivery. The market for medical technology in India is small, but rapidly expanding. It is nascent and highly fragmented with limited indigenous manufacturing - imports constitute over 75% of the estimated US$2.75 billion market. A transforming medical technology landscape, improving healthcare delivery and financing mechanisms, and changing patient profile are driving growth in the medical technology industry. This event looks at solutions to make modern healthcare accessible, available and affordable to all. CAHO which is the Consortium of Accredited Healthcare Organizations aims to promote patient safety and quality by training and creating resources. It also believes that appropriate, cost effective technology can help the hospitals to bring about safer and high quality healthcare delivery.  CAHO believes that nurturing and mentoring innovation can bring about a change in the healthcare delivery system. CAHOTECH was thus started as one-day event at Bangalore to bring the technology partners and healthcare industry to a common platform. This has grown in size to include start-ups, hospital innovations and bridging the gap. This year CAHOTECH 2019 which is the fourth conference has gone international and has speakers bringing in global perspective and will be held at IIT Madras Research Park in Chennai from September 27-28, 2019. More than 1,000 healthcare professionals from across the country will be attending the event this year to keep themselves up-to-date with latest technology and products. A major highlight of the event will be the presence of equity investors and venture capitalists who will be assessing participating start-ups for funding opportunities in healthcare technology space. Start-ups will also get to explore opportunities for incubation and engaging with hospitals for beta testing of products. Dr. Vijay Agarwal, President CAHO said, “The international healthcare technology conference organized by CAHO is the definitive event for health and technology innovation, investment and best practices. It showcases the latest technology based solutions to enable maximum efficiency at hospitals. It is the only platform of its kind that brings together healthcare organizations and technology companies under one roof to share and utilize their experience and adopt more efficient practices by healthcare organizations. The objective is to help introduce newer and better technology solutions to hospitals.” Dr. Lallu Joseph, Secretary General, CAHO said, “The solutions to the problems are best identified and solved by the hospital teams themselves. This conference also brings such hospital innovations to be presented to other hospitals to adopt these solutions and also innovate and find simple solutions for their inherent problems.” According to J Adel, Organizing Secretary, CAHOTECH 2019, “Technology these days plays a critical role in increasing operational efficiency and profitability of healthcare providers. It is a driving force behind quality healthcare, helping increase provider capabilities and enabling them to offer better patient care. The focus of CAHOTECH 2019 will be on technological innovations in the areas of process efficiency and optimum utilisation, enhancing clinical and patient care and empowering patients. This year, we are also bringing health-tech start-ups and investors on the same platform. The aim is to capture good technology at early stages and empower the innovators to scale up and grow.” Added Sameer Mehta, Organizing Chairman, CAHOTECH 2019: “The event this year will be on even a grander scale than before. An important aspect will be sharing of experiences and key learnings regarding technological innovations already functional at some of our member hospitals. There will also be assessment of newer technologies and showcasing of promising start-ups. CAHOTECH 2019 will also facilitate business discussions through a separate arm of vendors showcasing their latest technology and products.” Over two days, CAHOTECH 2019 will see presentations and discussions on different areas of healthcare, analysing real-life case studies and the change in efficiency that technology can bring. The conference will be focused on showcasing future healthcare technologies for clinicians, hospital managers and administrators, biomedical engineers, scientists, researchers and other stakeholders interested in promoting change through innovation and advancement in healthcare. Several workshops and masterclasses will be held on strategic planning of IT infrastructure, cyber-security, point-of-care medical devices, use of technology in medical education and healthcare engineering and maintenance.   ]]> https://biospectrumindia.com/news/97/14468/accutest-biologics-gets-global-honour-.html https://biospectrumindia.com/news/97/14468/accutest-biologics-gets-global-honour-.html Mon, 19 Aug 2019 14:35:00 +0530 India’s clinical contract research industry, with the current market size of USD 500mn is poised to double over five years and achieve Billion dollar market club. As a leading Indian Contract Research Organisation (CRO) Accutest Biologics Private Limited (ABPL) is all set to leverage the growing global demand for Biologics and Biosimilar drugs. The leading CRO for Biochemical characterization and Bioanalytical services, in support of preclinical and clinical development of Biologics and Biosimilars, ABPL has recently received a global honour with the OECD-Good Laboratory Practice (GLP) certification for the next three years. National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) had conducted a detailed pre-inspection of the test facility located at Navi Mumbai and this year in May, India’s only standalone test laboratory of ABPL received the GLP certification. The recent Organisation for Economic Co-operation and Development (OECD)-Good Laboratory Practice (GLP) certification for Bioanalytical services, Biochemical characterization and the In vitro bioassays conducted in its Navi Mumbai facility would act as a powerful catalyst for global pharma companies from the US, Europe, and other emerging markets to get ABPL services. Dr. Satish Sawant - Founder and CEO, ABPL said, “The Navi Mumbai facility is capable of conducting toxicity studies, mutagenicity studies, analytical and clinical testing. This significant milestone enables us to advance as the global service provider living up to the biopharmaceutical industry expectations and maintaining high-quality deliverables.” Rising demand for low cost medicines, growth of R&D sourcing, a large number of biologics going off-patent, growing biologics & biosimilar market and removal of regulatory bottlenecks for clinical trials are main growth drivers for the sector. As per industry estimates, biologics worth $100 billion in sales will go off-patent by 2020 and entail huge pipeline for bio-similar drugs. Asia pacific is expected to capture one-third of bio-similar sales in next 5-6 years. Dr. Mallikarjun Dixit, Test Facility Management at ABPL said, “The certification places ABPL in the select league of CROs that have been awarded such a global honour. It is a matter of pride and privilege for ABPL not only to serve the biopharma industry with established credibility and also to get recognized in all the OECD member countries for mutual acceptance of the data.” Industry expects the India CRO market to reach around $1 billion by 2023 from $500 Million in 2017, with a CAGR of 12.00%. India is emerging as a top destination for CRO because of the Acceptance of International guidelines and intellectual property rights, Presence of diverse types of climatic conditions thus allowing stability studies to be performed with ease in one destination, Highly experienced, educated and accessible human resource, Presence of diverse ethnic pool thus enabling diverse sample for clinical trials and Low operational cost due to cheap human resource. The CRO services market is valued at $36 Billion in 2017 and projected to reach to $56 Billion by 2023, at a CAGR of 7.6%.   ]]> https://biospectrumindia.com/news/97/14467/accutest-biologics-receives-global-honour.html https://biospectrumindia.com/news/97/14467/accutest-biologics-receives-global-honour.html Mon, 19 Aug 2019 13:40:00 +0530 India’s clinical contract research industry, with current market size of USD 500mn, is poised to double over five years and achieve Billion dollar market club. As a leading Indian Contract Research Organisation (CRO) Accutest Biologics Private Limited (ABPL) is all set to leverage the growing global demand for Biologics and Biosimilar drugs. The leading CRO for Biochemical characterization and Bioanalytical services, in support of preclinical and clinical development of Biologics and Biosimilars, ABPL has recently received a global honour with the OECD-Good Laboratory Practice (GLP) certification for the next three years. National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) had conducted a detailed pre-inspection of the test facility located at Navi Mumbai and this year in May, India’s only standalone test laboratory of ABPL received the GLP certification. The recent Organisation for Economic Co-operation and Development (OECD)-Good Laboratory Practice (GLP) certification for Bioanalytical services, Biochemical characterization and the In vitro bioassays conducted in its Navi Mumbai facility would act as a powerful catalyst for global pharma companies from the US, Europe, and other emerging markets to get ABPL services. Dr. Satish Sawant Founder and CEO, ABPL said, “The Navi Mumbai facility is capable of conducting toxicity studies, mutagenicity studies, analytical and clinical testing. This significant milestone enables us to advance as the global service provider living up to the biopharmaceutical industry expectations and maintaining high-quality deliverables.” Rising demand for low cost medicines, growth of R&D sourcing, a large number of biologics going off-patent, growing biologics & biosimilar market and removal of regulatory bottlenecks for clinical trials are main growth drivers for the sector. As per industry estimates, biologics worth $100 billion in sales will go off-patent by 2020 and entail huge pipeline for bio-similar drugs. Asia pacific is expected to capture one-third of bio-similar sales in next 5-6 years. “The certification places ABPL in the select league of CROs that have been awarded such a global honour. It is a matter of pride and privilege for ABPL not only to serve the biopharma industry with established credibility and also to get recognized in all the OECD member countries for mutual acceptance of the data,” said Dr. Mallikarjun Dixit, Test Facility Management at ABPL. Industry expects the India CRO market to reach around $1 billion by 2023 from $500 Million in 2017, with a CAGR of 12.00%. India is emerging as a top destination for CRO because of the Acceptance of International guidelines and intellectual property rights, Presence of diverse types of climatic conditions thus allowing stability studies to be performed with ease in one destination, Highly experienced, educated and accessible human resource, Presence of diverse ethnic pool thus enabling diverse sample for clinical trials and Low operational cost due to cheap human resource. The CRO services market is valued at $36 Billion in 2017 and projected to reach to $56 Billion by 2023, at a CAGR of 7.6%. ]]> https://biospectrumindia.com/news/97/14453/mte-successful-for-early-detection-of-breast-cancer-in-india.html https://biospectrumindia.com/news/97/14453/mte-successful-for-early-detection-of-breast-cancer-in-india.html Wed, 14 Aug 2019 16:55:00 +0530 Delhi hosted Dr Frank Hoffmann, who pioneered the internationally accepted Discovering Hands concept and ‘Tactile Breast Examination’ (TBE) technique.  In his presence, the CK Birla Hospital for Women, Gurugram and the NAB India Centre for Blind Women revealed that his method’s application saw a high level of sensitivity in the early detection of breast cancer among women screened in Delhi NCR over the last three months. A validation study was started by the CK Birla Hospital for Women and NAB India Centre for Blind Women in March 2019, with support from the Bayer Crops Science Group in India in collaboration with Discovering Hands, Germany. Tactile Breast Examination is a unique breast screening technique that uses the highly developed sensory skills of visually impaired women for manual breast health screening. Commenting on the findings emerging from the study, Dr Mandeep Malhotra, Director, Surgical Oncology & The Breast Centre, CK Birla Hospital for Women said, “The country is witnessing a steady rise in incidence of breast Cancer (~11.54%,  Globocan 2012) and also mortality due to the disease (~13.82%, Globocan 2012). In urban areas, one in 22 women are likely to suffer from breast cancer during their lifetime. Of these, 50% may not survive within five years of diagnosis. Inadequate screening and advanced stage of presentation are the contributors to the rising death toll.  Early detection by effective screening protocols is the possible solution.” According to American Cancer Society Guidelines, the standard screening process of mammography, should start at the age of 45. Breast cancer in Indian women is a decade younger in comparison to western women with peak incidence at 40– 50 years and Indian women have inherently higher breast density. Both the facts suggest limited application of screening mammography in Indian settings. The manual breast screening methods in the form of Self Breast Examination (SBE) and Clinical Breast Examination (CBE) are also sparingly used. SBE is limited by the lack of proper knowledge and confidence and CBE by the lack of sufficient time and resources. In the process of finding a possible solution for early detection, we evaluated the enhanced touch (Tactile Sensation) of a visually impaired (Blind) women, called as Medical Tactile Examiner (MTE), who have been trained to conduct Breast Examination (Discovering hands concept). In the last 4 months, more than 500 random women from Gurgaon other parts of Delhi NCR have undergone TBE; along with Ultrasound Breast for less than 40 yrs and Mammogram for more than 40 yrs of age. The initial trends suggest very high level of sensitivity for detecting breast lesions. Changes were detected in 30% women, 40% of which were confirmed by radiology and 20% had cancerous or precancerous changes. Majority of them were still at stage I and stage II.  Overall 3.5 % of women were detected with lesions that could have affected them adversely, i.e. the Blind women have been able to improve survival of 17 women in last 4 months. The examination by MTE also involves recording of risk factors for breast cancer including family history, teaching women how to do SBE, encouraging them to undergo timely radiology. Less than 2%, women, were into any kind of active breast screening while post TBE, majority of them started doing Self Breast Examination and have committed to timely MTE/CBE and radiology. Apart from detecting 17 women with lesions having adverse pathology, extrapolating 1 in 22 lifetime risk in 500 women, the blind women by their skills have improved survival of another 23 unfortunate women who will develop breast cancer in future. The above trends describe the immense potential of Visually impaired women who after adequate training can make a huge difference in tackling the rising menace of breast cancer, thus saving precious lives of us enabled people. Dr. Frank Hoffmann, eminent Gynaecologist from Germany has developed a methodology known as TBE that uses a standard system based on a patented orientation stripes and high sensory touch of visually impaired women. His social enterprise “Discovering Hands (DH)” trains these women over 9 months to conduct safe, repeatable, and accurate clinical breast examinations without any radiation or side effects. During the examination lasting 30-40 minutes, trained examiners can detect abnormalities which are 50% smaller (6-8 mm) and up to 30% more than doctors in the standard examination. DH has examined more than 1 lac women in Europe. He intends to bring similar success to India and around the globe. One of the study results that he presented says that TBE is equivalent to CBE check-up, hence is a strong option for women to exercise breast screening check-up. Dr. Frank Hoffmann’s (of Erlangen University) study results say; TBE check-ups are equivalent to CBE or even better. As a doctor who has been established for over 25 years, he found that the CBE is often carried out under unfavourable conditions and could therefore be improved.  His idea to turn the disability of blind and visually impaired people into a life-saving talent led to the founding of his social enterprise Discovering Hands. Speaking on the occasion, Avanti Birla, Founder, CK Birla Hospital for Women, said, “The CK Birla Group is deeply committed to creating sustainable positive impact. Over the last 150 years, the Group has allocated significant resources to philanthropic initiatives. Going forward, a large part of the Group’s impact activities will be focused on Women and Healthcare, in line with our commitment to promoting Diversity not just in our workplace but also in communities around us. HFW Foundation, a charitable institution, is an expression of this commitment. The CK Birla Hospital for Women is working on various initiatives including breast ancer. The HFW Foundation will be supporting this cause.” Akshat Seth, Chief Operating Officer, CK Birla Hospital for Women added, “One of the first initiatives of the HFW Foundation will be on building awareness for Breast health and improving access to Breast screening. With a breast cancer prevalence rate of 1 in 22 in urban areas, the focus of the Foundation will be on early detection, through TBE, to improve the chances of survival and organ preservation. Initially, the Foundation will work with communities in and around Delhi NCR and then in other parts of the country as well.” Shalini Khanna, Secy. & Director of National Association of Blind women has been working towards skilling blind women on life skills and employability for over 20 years. She was instrumental in getting Discovering Hands project to India with support from Bayer Crop Science. NAB got the trainers trained in Germany and has trained 14 visually impaired girls as Medical Tactile Examiners (MTEs) till now in pilot phase. The trained MTEs are currently running camps at various corporates, through local Rotary clubs and at various Resident Welfare Associations. They are also working as Interns at various hospitals. The high inherent sensory touch and focus that visually impaired women possess, is a huge factor to identify smallest of the abnormalities in breast. She aspires Discovering Hands should be able to substantially improve the early detection check from its current level and reaches out to more women in different cities in India, thus empowering more blind women of the country to be able to be independent in their lives with a new vocation of a kind.   ]]> https://biospectrumindia.com/news/97/14450/bd-medical-pharma-systems-set-with-technovation-season-9.html https://biospectrumindia.com/news/97/14450/bd-medical-pharma-systems-set-with-technovation-season-9.html Wed, 14 Aug 2019 16:45:00 +0530 BD Medical-Pharmaceutical Systems is all set to organise its annual flagship event ‘Technovation’ Season 9 on the emerging trends and innovative technologies for the pharmaceutical industry. With this year’s theme 'Together Towards a Healthier Tomorrow', Technovation will be conducted across three cities – Mumbai (August 20), Ahmedabad (August 21) and Hyderabad (August 22). The programme will witness participation from leading pharmaceutical and biotechnology companies across these cities. The event will further BD’s efforts to strengthen partnerships with pharmaceutical companies and bring relevant solutions to create a positive impact on the lives of patients. This edition will bring together global experts to talk about innovation in packaging for complex biologics through evolving self-administration devices, technical services, evolving quality landscape to support customer needs and regulatory services and support from BD. It will also focus on the regulatory aspects including the discussions on FDA and European regulations. Commenting on the upcoming event, Pavan Mocherla, Managing Director-BD India & South Asia said, “With Technovation, we aim to create a platform to bring key pharma stakeholders together for knowledge sharing and discussions to advance patient outcomes by ensuring compliance, ease of use and adherence to treatment. This season will have focussed discussions on self-administered devices and the impact of such technologies on the lives of patients suffering from chronic diseases. Such initiatives not only help us engage closely with our customers but also help us equip each other with the best know-how to create a healthier tomorrow.” The upcoming event will also focus on the regulatory aspects and will include the discussions on the FDA and European regulations and how technical and quality services play a critical role in delivering a positive impact on patient outcomes. ]]> https://biospectrumindia.com/news/97/14407/medgenome-unveils-novel-dna-test-for-all-dr-mutations-in-tb.html https://biospectrumindia.com/news/97/14407/medgenome-unveils-novel-dna-test-for-all-dr-mutations-in-tb.html Thu, 08 Aug 2019 15:55:00 +0530 MedGenome Labs, leader in clinical data driven genetic diagnostics and drug discovery research in India, has developed ‘SPIT SEQ’,  the first Whole Genome Sequencing based test that can provide a detailed analysis of every single mutation present in any tuberculosis (TB) bacteria causing drug resistance (DR) directly from the sputum. This break-through will enable a doctor to quickly and accurately prescribe the most effective drug to a tuberculosis patient without a trial and error process, followed currently that takes a month. This test has been validated with over 100 samples where it recorded with 100% sensitivity and 98.04 % specificity when compared with Line Probe Assay (LPA). 50 out of those samples were in association with P.D. Hinduja Hospital and Medical Research Centre, Mumbai. A manuscript is under review for publication.  “SPIT SEQ is a massive breakthrough that can help millions. This particular test not only brings accurate results but also saves a lot of time where TB treatment is concerned. In lines with India’s objective to counter TB effectively and quickly, we aim to benefit the last person living with TB today. The test is prices at Rs 7500 currently but we hope bring down the price later on. We have collaborated with the National Tuberculosis Institute and we will be studing 500-1000 cases for the next 1 year using SPIT SEQ.”, said Dr VL Ramprasad, COO, MedGenome Labs. With the flagship test for tuberculosis ‘SPIT SEQ’, MedGenome Labs is entering into infectious disease genetics and collaborating with XCyton Diagnostics, Bangalore. This collaboration will boost integration of various genetic tests under infectious diseases available with XCyton through the network established by MedGenome Labs. These tests include eye infections, brain and blood infections. MedGenome will be the exclusive sales partner for all XCyton tests in India. “Infectious diseases remain a major challenge, leading to significant healthcare expenditure, for India. This partnership can act as a synergy in India’s quest against infectious diseases. MedGenome’s reach across India’s geography will prove to be pivotal in the success of integrating genetic testing in healthcare service segment while we at XCyton continue to be focused on research and development of current as well as new tests.” said Dr B V Ravikumar, Founder and Managing Director, XCyton Diagnostics Ltd. XCyton Diagnostics's invention Syndrome Evaluation System (SES) allows for the immediate identification of multiple organisms inclusive of Bacteria, Viruses, Fungi and Parasites. This SES tool was launched back in 2012 and has since then catered to 17000 patients. "Although SES was initially intended to meet the diagnostic needs of clinicians, it became apparent after introduction into clinical practice that it is a powerful management tool  that can save lives, reduce morbidity and hospitalization costs”, said Dr V Ravi, Senior Professor and Head, Dept. of Neurovirology, NIMHANS. ]]> https://biospectrumindia.com/news/97/14404/innaccel-launches-vapcare-device-for-ventilated-patients.html https://biospectrumindia.com/news/97/14404/innaccel-launches-vapcare-device-for-ventilated-patients.html Thu, 08 Aug 2019 14:20:00 +0530 InnAccel, India’s first product innovation platform with a diverse portfolio of globally patented medical technologies has launched VAPCARE, the world’s first automated, and intelligent secretion clearance and oral hygiene management system for ventilated patients. VAPCare is the first device of its kind in the world, and automates today’s manual process of secretion clearance and oral cleansing performed by nurses. Secretion management and oral hygiene care is critical for reducing the risk of Ventilator-Associated Pneumonia (VAP), a type of lung infection that effects ICU patients on mechanical ventilators, and directly leads to over 250,000 deaths annually in India alone. Manual suctioning of secretions is time-consuming, and the shortage of well-trained nurses means that this protocol is not always followed. By automating this critical infection prevention processes, VAPCare improves protocol compliance and consistency, and is expected to drastically reduce VAP cases and VAP related deaths. VAPCare has been developed by Coeo Labs, the critical care division of InnAccel Technologies. Speaking on the first-of-its-kind product, Nitesh Jangir, Lead Engineer, Coeo Labs, said, “People admitted to ICUs often contract VAP, an infection caused by the bacteria that collect in the lungs of a patient who has been on a ventilator for more than 48 hours. VAPCare addresses this issue by completely automating oral hygiene management. Through its patented technology platform, VAPCare intelligently clears secretions from 3 areas, and allows the doctor to customise the protocol depending on each patient’s clinical needs.” “VAP is quite common among patients in critical care settings. Unfortunately, consistency of secretion management and oral hygiene protocols is often poor. In fact, this is a leading cause of VAP, resulting in 600K cases in India every year. We wanted to address this problem with VAPCare, which automatically removes saliva before it reaches the lungs and also pushes anti-microbial liquid into oral cavities. It increases ICU efficiency and eliminations multiple risk factors that are associated with the manual-suctioning process,” commented, A Vijayarajan, CTO, InnAccel Technologies. VAPCare was developed with support from BIRAC (Government of India), has been approved by the U.S. FDA, and has received a number of innovation awards in India and abroad. These include the Go Austria Winner 2017, the Silver Award in Mass Challenge Boston 2016, and a Top 16 Healthcare Technology Winner from the American College of Cardiology in 2015. VAPCare has undergone extensive technical and clinical evaluation. A 30-patient clinical evaluation was recently completed with excellent results. The device not only improved patient safety by bringing down cases of mucosal injury, but also increased the effectiveness of secretion clearance. Most importantly, no incidents of VAP were reported. The device has been evaluated by some of India’s top medical facilities including AIIMS, Delhi; NH, Bangalore and NIMS, Hyderabad. “VAPCare has a strong physiological basis to help decrease the incidence of VAP. We observed no VAP in the initial cases, and are excited to evaluate the technology further”, stated Dr. Vimal Bhardwaj, NH Bangalore.   ]]> https://biospectrumindia.com/news/97/14390/ansal-university-medanta-to-address-recent-trends-in-cardio-tech.html https://biospectrumindia.com/news/97/14390/ansal-university-medanta-to-address-recent-trends-in-cardio-tech.html Wed, 07 Aug 2019 11:20:00 +0530 Ansal University hosted Cardiovascular Technology Conference in collaboration with Medanta-Medicity at hospital premises, Gurugram. The event focused on cardiovascular-related concerns such as imaging (i.e. CT angiography, ECG/TMT, and echocardiography), intervention, arrhythmias and pacing, prevention, and improving the trained workforce to save lives. The conference served as a unique platform for cardiac technologists and novice researchers from various institutions to share and exchange new clinical studies and advancements dealing with cardiac diseases. Prof Monica Chaudhry, Director, School of Health Sciences, Ansal University said “We are much enthusiastic and joyous to see Medanta willing to contribute to the cause. We are delighted to build this association. The university believe passion is not all a student requires to strive for their ambitions. It has to gel with the right opportunities and facilities, only then it could serve as a ladder to success. And we, at AU, choose to be that ladder, offering them every stair they require to climb and build their success from. We let our students imbibe and experience real-life medical situations as we provide them with cardiovascular equipped labs. It further helps them in becoming familiar with the profession they are about to step in.” Ansal University widened its approach and provided the students with hands-on practical experience along with the exposure to cardiovascular equipment.  Giving a laboratory experience to students will promote a higher success rate of the cardiovascular concerns, as the professionals entering the industry will be familiar with the equipment already. The awareness about cardiac care is gradually increasing with time, and Ansal University aimed to promote the sector better through endeavours such as the conference. The university also offers courses in health sciences to construct a better future for the aspiring students. Dr Naresh Trehan, Chairman and MD, Medanta said, “There are nearly 50 crore people who require healthcare. The sector remains in demand and will eventually affect the future. The industry of healthcare is swarming with opportunities, it carries a lot of scope, but everything ultimately comes down to amenities and what they plan to accomplish with them. Cardiovascular technology is flourishing eventually, and it further enables us to create clinical practitioners, brightening the future that stands ahead of the medical industry. Medanta supports Ansal University in their venture and will do the needful to encourage growth, education and success in the sector.” Speaking on the occasion Dr Ravi R Kasliwal, Chairman - Clinical & Preventive Cardiology of Medanta said, “Associating with Ansal University, we plan to introduce modern-day techniques and digital education for students to absorb and hone their skillsets from, which further helps them in providing quality care to patients. The varied approach would empower learning and heighten the productivity of the sector and the overall performance of the students. We aim to discover viable ways to mend patient care and meritoriously contribute to the ever-changing medical industry. The collaboration primarily enables us to cultivate an assemblage of skilled clinical practitioners who further address the intensified demand of the cardiology assistance and medical sector.” The conference concluded as a huge success, contributing its bit to the sector of medical sciences. ]]> https://biospectrumindia.com/news/97/14379/meril-life-sciences-receives-ce-mark-for-bioresorbable-scaffold.html https://biospectrumindia.com/news/97/14379/meril-life-sciences-receives-ce-mark-for-bioresorbable-scaffold.html Tue, 06 Aug 2019 12:45:00 +0530 Meril Life Sciences announced that MeRes100 BRS, its indigenously designed and manufactured scaffold, became the first thin-strut bioresorbable scaffold to receive CE marking. Meril’s MeRes100 has received both DCGI  and CE (European Conformity) marketing approval. Backed by rigorous research and encouraging clinical trial data, MeRes100 is planned to be launched in various countries, including European countries, later this year. Cardiovascular diseases (CVDs) such as coronary artery disease are the biggest cause of mortality in India and there is evidence that CVD begins to affect Indians at least a decade earlier than it affects Europeans. Stents are widely accepted as a primary intervention for treating coronary artery disease and associated lesions or blockages due to fat deposition and plaque formation. Metallic drug eluting stents (DES) have a metallic platform with drug coating. The role of a DES is to provide temporary scaffolding to the blockage or lesion site and also to deliver a drug to facilitate healing. After healing is complete, the metallic stent remains in the body as a permanent implant. Such metallic DES are associated with incremental risk of clinical or adverse events: on an average, 2-3% of patients with metallic DES implants may require a repeat intervention year on year. MeRes100 was designed as a solution to bridge this gap between the temporary treatment horizon for opening a blockage and the undesirably permanent nature of a metallic DES implant. Across clinical trials, MeRes-1 (the first in-human study conducted in India) and MeRes-1 Extend (conducted in Brazil, Europe and Asia), MeRes100 BRS has shown long-term positive safety and sustained efficacy outcomes for patients with coronary artery disease in treatment of de-novo coronary artery lesions. Its proprietary hybrid-cell design has optimal strut thickness and improved crossing profile for better deliverability. The scaffold strut thickness is 100 microns, which leads to faster endothelialization and healing, resulting in lower risk of scaffold thrombosis. Both trials have also validated this benefit, by demonstrating zero scaffold thrombosis and very low major adverse cardiac event (MACE) rate of 1.87% with MeRes100 BRS in MeRes-1 Study at three years and 1.61% MACE in MeRes-1 Extend Study at two years.  The data was recently presented by Co-principal Investigator of MeRes-1 Study, Dr. Praveen Chandra, Chairman of Interventional Cardiology at Medanta – The Medicity, Gurgaon, India, who commented, “The cumulative major adverse cardiac event (MACE) rate, which includes cardiac death, heart attack, and Ischemia-driven TLR/ repeat procedures, is better at 3 years for MeRes100 as compared to previous generation BRS technology.” “First generation bioresorbable scaffolds have not shown the most favourable results at long term horizons. The next generation bioresorbable scaffold with reduced strut thickness, improved profile for better deliverability, faster degradation and possibly lower scaffold thrombosis is a revolutionary advance in interventional cardiology” said Principal Investigator for the MeRes-1 trial Dr. Ashok Seth, Chairman of Fortis Escorts Heart Institute in New Delhi, India. Sanjeev Bhatt, Vice President-Corporate Strategy, Meril Life Sciences said, “Intensive research and development efforts exerted by 150 scientists, chemists, engineers and researchers at Meril’s research facilities in Vapi, Gujarat over five years have culminated to multiple regulatory approvals and over seven patents. This is the first time three-year data of a next generation thin strut BRS has been presented in the world with consistency in safety and efficacy (0% stent thrombosis and low MACE rate of 1.87%) – a truly proud moment for Meril Life Sciences. We have certainly created a device with excellent characteristics, which promises to be effective as well as safe when implanted for the treatment of coronary artery disease.” Long-term three-year follow-up data of the MeRes-1 study, published in EuroIntervention, which includes a combination of clinical follow-ups as well as angiographic and intravascular imaging demonstrated the high efficacy of MeRes100 at two years with low late lumen loss (0.24±0.34mm), virtually complete strut coverage (99.24%) and sustained mean flow area with very low percentage volume obstruction (7.5%). Strut coverage indicates the extent of healing; it is a key measure of efficacy and MeRes100 was designed with a thinner strut and highly biocompatible material to ensure high strut coverage, which also indicates lowered risk of adverse cardiac events and also reduced probability of repeat procedures.   ]]> https://biospectrumindia.com/news/97/14355/trivitron-inks-strategic-alliance-with-c-camp.html https://biospectrumindia.com/news/97/14355/trivitron-inks-strategic-alliance-with-c-camp.html Fri, 02 Aug 2019 09:00:00 +0530 Trivitron Healthcare Private Limited, a leading medical device company providing affordable healthcare solutions to the healthcare industry, has entered into a strategic partnership by signing a Memorandum of Association (MoU) with the Centre for Cellular And Molecular Platforms (C-CAMP), an initiative of the Department of Biotechnology, Ministry of Science and Technology and Earth Sciences, Govt. of India. This partnership is a strategic step for both Trivitron and C-CAMP towards co-development of world-class healthcare technologies completely indigenously under “Joint Intellectual Properties” (i.e. product and process patents and know-how) aegis. The MoU was signed in the presence of Dr. Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India & Chairperson, Biotechnology Industry Research Assistance Council (BIRAC); Dr. Taslimarif Saiyed, CEO & Director, C-CAMP; and Dr. G. S. K. Velu, Chairman & Managing Director, Trivitron Healthcare Private Limited. C-CAMP has developed and tested an indigenous multiplex fluorescent microfluidic-analyser, covered under two patents; a base-patent for microfluidics flow analyser, which is filed and granted in several geographies, and a follow-on patent covering multiplex functionality. C-CAMP will demonstrate proof of concept and will participate in the co-development of a biological fluid analyser for clinical diagnostics. By the MoU, Trivitron which has a history of developing and installing diagnostic devices, including imaging devices globally is expected to facilitate these C-CAMP developed technologies in reaching a wider market segment commercially. Confirming the development, Dr. Taslimarif Saiyed, CEO & Director, C-CAMP said, “The MoU between C-CAMP and Trivitron would mark a new beginning in the healthcare space with emergence of ground breaking technologies from India developed completely indigenously. This effort would be the first step from India in this direction. Our technology will be in line with international healthcare technological trends and there will be joint work on arriving at product specifications and requirements for commercially and clinically viable devices. The tie up will not only facilitate the technology but also manufacturing of associated devices taking into consideration the desired cost-effectiveness and requirements for commercial viability.” Speaking on the occasion, Dr. G. S. K. Velu said, “We are delighted to be partnering with C-CAMP. They are today among India’s most exciting and unique life sciences innovation hubs that brings together academia, industry and the startup ecosystem on one platform. India is today witnessing massive development in the healthcare space, opening avenues for new advancements and innovations. As a medical technology company providing affordable healthcare solutions, Trivitron constantly pursues technological innovations to offer superior, and yet cost-effective clinical benefits. The alliance with C-CAMP is in line with this endeavour and we are confident that C-CAMP’s culture of innovation and excellence will enable us to provide technologically more advanced devices for enhanced diagnosis and treatments.” Trivitron will also work along with C-Camp to co-develop other relevant technologies and devices in the fields of point-of-care testing, microfluidics, and multiplex detection, which are within the domain of expertise and of strategic interest to Trivitron & C-Camp. ]]> https://biospectrumindia.com/news/97/14327/stryker-launches-breakthrough-technology-to-support-breast-cancer-patients.html https://biospectrumindia.com/news/97/14327/stryker-launches-breakthrough-technology-to-support-breast-cancer-patients.html Tue, 30 Jul 2019 14:35:00 +0530 Global medical device company, Stryker announced the launch of its state-of-the art Fluorescence Imaging (FI) technology, Spy-Phi, for better outcomes and safety of patients suffering from breast cancer. The only of its’s kind technology in the world uses near-infrared fluorescence imaging during cancer surgery that allows real time, clinically significant and actionable information to improve quality of care and lower overall healthcare burden. During breast cancer surgery, surgeons inject a safe and affordable ICG dye in patients. Using Spy-Phi imaging technology, they can view blood flow in vessels, micro-vessels, tissue perfusion and critical anatomical structures intraoperatively. The relevant tissues light up in fluorescent green color. The reliability and multiple applications of the imaging are a significant differentiation compared to currently used technologies like Blue dye. The technology can be used in various procedures, but is especially helpful in mapping of lymphatics, identification of lymph nodes and confirming adequate tissue perfusion for safe breast reconstruction. Once the lymph node is identified, it is removed and then sent for frozen section in the lab to stage the cancer which helps to decide the further line of treatment. Renowned breast cancer expert Dr David Weintritt from GW School of Medicine and Health Sciences, US, visited India to hold clinical workshops on the role of Fluorescence Imaging in breast cancer surgery and reconstruction. “Rising prevalence of cancer and complexity of surgeries we perform is making infrared fluorescence imaging increasingly critical as it is beneficial in detecting pathways of cancer spread more precisely and in preventing complications in breast cancer surgeries. Fluorescence Imaging uses near infrared technology and indocyanine green (ICG) dye that rapidly visualizes lymph nodes that can otherwise be challenging for surgeons to navigate. It has the potential to help save and improve lives of many patients suffering from breast cancer. Further, because the information is obtained real time during the surgery, we can now prevent several complications proactively and reduce the overall cost of healthcare,” stated Dr. Weintritt. Excited about the launch, Ms. Meenakshi Nevatia, Managing Director, Stryker India, shared, “Spy-Phi is a unique and highly advanced fluorescence imaging technology that can be used in plastics, microsurgical, reconstructive and gastrointestinal procedures. We’re proud to bring Spy-Phi to India and are looking forward to the incredible impact this technology can have in making healthcare better.” ]]> https://biospectrumindia.com/reports-white-papers/97/14324/medical-drones-market-size-to-exceed-399m-by-2025.html https://biospectrumindia.com/reports-white-papers/97/14324/medical-drones-market-size-to-exceed-399m-by-2025.html Tue, 30 Jul 2019 13:45:00 +0530 Technological advancements in medical drones will improve its efficiency that should increase its preference during emergency cases. Key industry players heavily invest in R&D activities to develop innovative medical drones. For instance, companies are developing drones with diagnostic imaging capabilities that will have role in assessing health in remote locations with the usage of telemedicine technology. Additionally, medical drones aid aged people and therefore, due to convenience offered by the technologically advanced medical drones, its adoption will remain high. Aforementioned factors will drive the industry growth. Growing public acceptance towards medical drones in developing economies will surge its demand, thereby propelling business growth. Government implements certain programs and initiatives to increase the awareness level regarding availability of superior quality medical drones amongst healthcare professionals in underdeveloped economies. Government promotes usage of medical drones due several associated benefits. Thus, increasing government initiatives will escalate acceptance and adoption of medical drones thereby, fostering the industry growth. However, complications associated with medical drones may hamper industry growth to some extent. Drugs/pharmaceutical transfer segment is anticipated to foresee around 25% growth in near future. Substantial growth is attributed to numerous capabilities of medical drone to deliver medications in remote locations at a faster pace. These drones help in delivering drugs during severe circumstances such as disasters or medical emergencies. There have been instances of medical drones saving lives of many people during natural calamities by providing necessary drugs. For instance, medical drones successfully delivered small packages of pharmaceutical drugs during earthquake, that helped people to get access to important medications. Thus, crucial role of medical drones during emergency cases will positively influence the segmental growth. Emergency medical services segment was valued more than USD 40 million in 2018 and it will continue to grow in coming years. Lack of access to medicines during critical cases is one of the leading cause of deaths in underdeveloped regions. Medical drones efficiently deliver medications in rural facilities as they can sense and avoid obstacles. Emergency medical services help people suffering from grave conditions, and medical drones facilitate the overall process. This scenario proves beneficial for the business growth as it augments demand for medical drones in emergency cases. UK medical drone market is anticipated to witness more than 25% growth during the forecast period. Extensive research is being conducted on delivering blood or medicines in remote areas of Wales.  Furthermore, improving regulatory scenario for medical drones will prove beneficial for the industry growth. Above mentioned factors coupled with increasing number of emergency cases in certain areas of UK will foster the medical drones market in the country during the analysis timeframe. Notable industry players operational in medical drones market are DHL, DJI, Embention, Flirtey, Matternet, Vayu and Zipline. These key industry players implement several strategies such as new product launches, partnerships and distributional channel expansion in new locations that will help them to sustain and capture higher market share. For instance, in March 2019, UPS partnered with Matternet for delivering medical samples by the usage of drone. This strategy will help the company to upsurge medical delivery, improve patient experience thereby, gaining lucrative market share.   ]]> https://biospectrumindia.com/news/97/14293/medtronic-launches-the-venaseal-closure-system-in-india-.html https://biospectrumindia.com/news/97/14293/medtronic-launches-the-venaseal-closure-system-in-india-.html Mon, 29 Jul 2019 09:00:00 +0530 India Medtronic Private Limited, wholly owned subsidiary of Medtronic plc has announced the launch of the VenaSeal™ Closure System, which is a minimally invasive procedure that uses a proprietary medical adhesive to close the diseased vein in patients with chronic venous disease (CVD) – a condition affecting more than 190 million people globally.  Healthy leg veins have valves that keep blood flowing to the heart. Venous reflux disease, also known as CVD, develops when the valves stop working properly and allow blood to flow backward (i.e., reflux) and pool in the lower leg veins. If CVD is left untreated, symptoms can worsen over time.  “Medtronic is committed to developing smart product and procedural solutions in the area of minimally invasive innovation to improve the quality of life for all patients,” said Madan Krishnan, vice president and managing director, India Medtronic Pvt Ltd. “VenaSeal is an innovative approach to vein closure and is designed to minimize patient discomfort and reduce recovery time. Thousands of patients around the world have benefited from this therapy and we are pleased to now offer this advanced technology in India.”  VenaSeal uses a medical adhesive to close the diseased vein, with high closure rates across three clinical trials. Using ultrasound, the physician guides a catheter through a small access site in the leg and into the diseased area of the vein. Once in place, the physician administers the VenaSeal adhesive at various points in a segmental fashion, and with manual compression, closes the vein. Blood is re-routed through other healthy veins in the leg.  This unique approach eliminates the risk of burning or nerve injury that is sometimes associated with thermal-based procedures. The procedure is administered without the use of tumescent anesthesia (multiple injections of a dilute local anesthetic), minimizing the need for multiple needle sticks. In the VeClose trial, patients reported minimal to no pain or bruising, post procedure. ]]> https://biospectrumindia.com/news/97/14274/medtronic-requests-approval-of-non-adjunctive-labeling-from-fda.html https://biospectrumindia.com/news/97/14274/medtronic-requests-approval-of-non-adjunctive-labeling-from-fda.html Wed, 24 Jul 2019 12:20:00 +0530 Medtronic plc, the global leader in medical technology, services and solutions, has announced its Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) requesting approval for non-adjunctive labeling for its Guardian™ Sensor 3, as part of the MiniMed™ 670G system. If the FDA approves a sensor with non-adjunctive labeling, it means that a sensor is accurate enough to be used to calculate an insulin dose for meals and to correct high glucose levels. Since Medicare requires a non-adjunctive label for sensor reimbursement, if approved, this labeling could broaden patient access by allowing for Medicare coverage of the world’s first and still the only commercially available hybrid closed loop system. The MiniMed 670G system is being used by more than 180,000 people today, and the associated data on nearly 8 million patient days shows an average Time in Range of 71% across all age groups, which mirrors the pivotal trial data published in the Journal of the American Medical Association (JAMA). Importantly, the clinical data meets the goals outlined in the Time in Range consensus guidelines recently published at the American Diabetes Association meeting. Overnight, when many individuals with diabetes worry about lows, MiniMed 670G system data shows Time in Range of 78% in a real-world environment, with less than 0.5% in the low ranges <54 mg/dL. The SmartGuard™ technology in the MiniMed 670G system automates and personalizes the delivery of basal insulin 24 hours a day and is the only commercially available technology in the world that proactively drives increased Time in Range by consistently guiding to the target of 120 mg/dL throughout the day-the lowest range offered in an automated insulin pump system.  The company’s submission for non-adjunctive coverage follows the launch of the enhanced Guardian™ Link 3 transmitter earlier this year, which improved the patient experience on the system by reducing the number of system alarms by 60%5, and allowing patients to spend an additional 2.2 hours per day utilizing the SmartGuard technology in Auto Mode, which automatically regulates basal insulin throughout the day and night.  ]]> https://biospectrumindia.com/news/97/14272/medtronic-partners-with-viz-ai-.html https://biospectrumindia.com/news/97/14272/medtronic-partners-with-viz-ai-.html Wed, 24 Jul 2019 11:55:00 +0530 Medtronic plc, a global leader in medical technology, and Viz.ai, the emerging leader in applied artificial intelligence (AI) in stroke care, have partnered to accelerate the adoption of Viz.ai’s new technology, which helps synchronize stroke care and decrease time to treatment, potentially improving outcomes for patients. Viz.ai’s technology uses artificial intelligence to identify suspected large vessel occlusion (LVO) strokes and automatically notify specialists. The Viz.ai software connects to hospital computed tomography (CT) scanners and alerts stroke specialists within minutes that a suspected LVO stroke has been identified, sending the radiological images directly to their smart phones where they can be viewed.Viz.ai enables a physician to provide the patient with the treatment they need as quickly as possible. “Medtronic is an innovative company focused on therapies that extend life and restore health,” said Dr. Chris Mansi, neurosurgeon, co-founder and CEO of Viz.ai. “As the largest medical device company in the world, Medtronic is an ideal partner to help physicians access Viz.ai’s cutting-edge technology to ensure as many patients get the care they need as quickly as possible.” “Viz.ai allows clinicians to receive an alert for suspected Large Vessel Occlusions and the corresponding visual data” said Dr. Elad Levy, chairman in the Department of Neurosurgery with the University at Buffalo's Jacobs School of Medicine and Biomedical Sciences and medical director of Neuroendovascular Services at Gates Vascular Institute. “The combination of AI powered alerts, mobile image viewing, and HIPAA compliant communication facilitates synchronization of stroke care with great potential to impactfully reduce door-to-needle time and help an increased number of patients.” Every two minutes someone in the U.S. has an LVO, but only an estimated 15 percent receive a potentially lifesaving mechanical thrombectomy, a minimally-invasive procedure that removes blood clots. A Viz.ai study in two centers showed that in 95.5 percent of true positive cases, its technology alerted the stroke specialist earlier than the standard of care, saving an average of 52 minutes. “Viz.ai is fast emerging as the leader in artificial intelligence in stroke care. We are excited about this partnership because Viz.ai’s technology has the potential to significantly reduce the time it takes for patients suspected of LVO stroke to receive the care they need,” said Stacey Pugh, vice president and general manager of Medtronic’s Neurovascularbusiness, which is part of the Restorative Therapies Group at Medtronic. “Viz.ai’s software coupled with our network is going to increase access to needed therapies. It greatly complements our existing portfolio.” Medtronic currently offers the Solitaire™ Platinum revascularization device, a unique stent that retrieves clots from occluded blood vessels in the brain for patients experiencing acute ischemic stroke (AIS) due to an LVO. Through this agreement, Medtronic will distribute Viz.ai’s existing LVO detection and triage software services, which are currently permitted for marketing in the U.S. It was the first clinical decision support software designed to analyze CT results that may notify providers of a potential stroke in their patients cleared by the U.S. Food and Drug Administration (FDA). The technology is available in over 200 hospitals, with the goal of making Viz.ai available to every stroke center in the country. Dr. Levy has no financial ties, nor has he received any compensation from Viz.ai.  ]]> https://biospectrumindia.com/news/97/14261/trivitron-healthcare-launches-fully-automated-clinical-chemistry-analyzer.html https://biospectrumindia.com/news/97/14261/trivitron-healthcare-launches-fully-automated-clinical-chemistry-analyzer.html Wed, 24 Jul 2019 09:00:00 +0530 Trivitron Healthcare, the ace Indian health technology organization, takes another leap in providing cost-effective diagnostic solutions with the launch of super-efficient clinical chemistry analyzer - ‘Nanolab 200’ and 5 part differential hematology analyzer with retic - ‘Cellenium 5D Retic’. With an aim to provide ‘Affordable Diagnostic Solutions for Today and Tomorrow’, Trivitron is committed to provide best in class diagnostic products . Nanolab 200 is a fully automated, compact benchtop clinical chemistry analyzer with a throughput of 200 tests per hour. The system includes multi-functional sample and reagent probe with collision protection and liquid level detection technology. Trivitron’s Nanolab 200 has a Teflon coated mixing arm with variable speed control options. Also, the system comes equipped with an inbuilt laundry customized for minimal water consumption making it most suitable technology. Trivitron Healthcare’s another offering, Cellenium 5D retic, is an advanced 5 part differential hematology analyzer with reticulocyte count technology and has a throughput of 60 samples per hour. The highly sophisticated instrument offers a wide range of hematological analysis including reticulocyte count and various other hematological research parameters. Cellenium 5D retic guarantees accurate and reliable differential count results, as it comes with a double WBC counting mode and laser light multi-dimensional classification system with resistant RBC mode. Additionally, the system is designed to facilitate ease of operation as it includes large touch screen display unit. Speaking on this occasion, Mr. Nitin Sawant, President – IVD, states - “Trivitron Healthcare has been pioneer in providing advanced healthcare technologies at affordable costs. Each of Trivitron’s product offerings are at par with international regulations. Nanolab 200 and Cellenium 5D Retic are highly efficient, user friendly and compact in design which makes them ideal technologies for  laboratories.” Trivitron’s diagnostics portfolio include a wide range of products - Newborn Screening Solutions, Clinical Chemistry, Hematology, Point of Care, Rapid cards, Immunology, Clinical Electrophoresis, Histopathology, Liquid based Cytology, Digital Pathology, Molecular Diagnostics and Analytical Instruments. ]]> https://biospectrumindia.com/news/97/14247/strand-life-sciences-joins-the-global-diagnostics-network.html https://biospectrumindia.com/news/97/14247/strand-life-sciences-joins-the-global-diagnostics-network.html Mon, 22 Jul 2019 13:55:00 +0530 Strand Life Sciences, India, has joined the Global Diagnostics Network (GDN), a strategic working group of major diagnostic laboratories collaborating to generate enhanced diagnostics insights to improve the delivery of global healthcare. The GDN, launched in October 2018 by U.S.-based Quest Diagnostics, consists of the following companies: Al Borg Medical Laboratories, Dasa, GC Labs, Healius, KingMed Diagnostics, and SYNLAB.  LSI Medience also joined the GDN. GDN initiatives will benefit patients, healthcare providers, pharmaceutical innovators, government agencies, non-governmental organizations (NGOs), and academic institutions. Starting priority areas of focus include the standardized delivery and development of high quality companion diagnostics for pharmaceutical companies, and the creation of an emerging pathogen preparedness network toexpedite infectious disease research and response. Additional initiatives will be rolled out based on regional and global priorities.    In India, Strand Life Sciences is focused on Oncology, Mother and Child, and technology enabled Wellness segments. “We are very pleased to join the GDN and learn from the rich experience of our fellow members as well as contribute through our special capabilities in genetics, bioinformatics and oncology” said Harish Natarajan, Chief Operating Officer and President, Clinical Diagnostics at Strand Life Sciences.   “We welcome Strand Life Sciences as a new GDN member, and are eager to continue acceleration of the network’s programs that will reach patients in every part of the world,” said Mark Machulcz, General Manager, Global Markets at Quest Diagnostics. “The GDN continues to make great strides in increasing access to diagnostic technology and innovation, and in building the largest global launch platform for rapid deployment of companion diagnostics.” Collectively, this worldwide community of nine leading healthcare companies has a presence in countries with two-thirds of the world’s population, and over 90% of the global pharmaceutical market.  ]]> https://biospectrumindia.com/news/97/14199/fortis-hospital-in-mulund-installs-most-advanced-robotic-surgery-technology.html https://biospectrumindia.com/news/97/14199/fortis-hospital-in-mulund-installs-most-advanced-robotic-surgery-technology.html Tue, 16 Jul 2019 11:45:00 +0530 Fortis Hospital, Mulund, one of the leading healthcare solution provider of Maharashtra, has installed Da Vinci Xi Robotic Surgical system, the most advanced Robotic surgery technology in the world, here today. The four-armed surgical robotic system will be used for the specialties of Urology, Oncology, Gynaecology, Head & Neck and Gastrointestinal surgery. The surgical system was inaugurated in presence of Dr S Narayani, Zonal Director, Fortis Hospital, Mulund; Dr Anil Heroor, Senior Consultant, Surgical Oncology & Head of the Department, Colorectal Surgery; Fortis Hospital, Mulund and Dr Pankaj Maheshwari Chief of Urology, Fortis Hospital, Mulund. The new Da Vinci Xi System acts as an extension of the doctor’s hands, allowing him or her to perform a surgery with pinpoint accuracy and very little damage to surrounding tissues. It will integrate skilled surgeons with advanced technology to aid in conducting complex surgical procedures. Designed for performing high precision surgeries, the surgical system will be operated by a specialized team of trained surgeons. Speaking about the utility of the system, Dr Anil Heroor, Senior Consultant, Surgical Oncology & HOD-Colorectal Surgery, Fortis Hospital, Mulund, said, “Use of this robotic surgical system will dramatically increase precision, visualization and dexterity with which the surgical procedures will be conducted; greatly benefitting the physicians and the patients. For patients, this will mean smaller incisions, shorter recovery time, and reduced incidences of hospitalization and its cost implications.” The advantages to the patient are manifold, this includes drastically reduced hospital stay, faster recovery, reduced risk of incision site infection, minimal blood loss, will enable preservation of healthy tissues, and significantly less scarring. The biggest advantage is these procedures are nearly pain-free with a drastic reduction in analgesic need.  The program may also enable many procedures to be carried out on single day hospitalization. Speaking further on patient advantages, Dr Pankaj Maheshwari Chief of Urology, Fortis Hospital, Mulund, said, “Patients who will undergo robotic surgery to correct their urological issues, mainly urological cancers and reconstructive procedures, will benefit immensely; the surgery will leave lesser scars, rapid return to continence and easier recovery of sexual function. Dr S. Narayani, Zonal Director, Fortis Hospital, Mulund, said, “The robotic system is one of the finest creations enabling complex surgery with high levels of patient safety. I am pleased to have this technology in Fortis Hospital, Mulund to take surgical care to another level.” ]]> https://biospectrumindia.com/news/97/14192/first-ever-medical-device-hackathon-for-geriatric-care.html https://biospectrumindia.com/news/97/14192/first-ever-medical-device-hackathon-for-geriatric-care.html Tue, 16 Jul 2019 09:00:00 +0530 The first of its kind Medical Device Hackathon “ReImagineHealth 2019” supported by MedTech and Geriatric Healthcare Technology Business Incubator, Centre for Product Design and Manufacturing, Indian Institute of Science (IISC), K-Tech, Government of Karnataka, various companies, hospitals, policy bodies, entrepreneurs, legal and regulatory organizations and NGOs in Bangalore. Fourteen teams consisting of 64 participants took part in the hackathon with each team having at least one person from the field of finance, engineering and medical along with mentors who have experience in these fields. Team Novae, who presented their product the ‘Sonic Walker’- a walker that helps detect obstacles and alert the user; Team Decubators who presented better and cheaper ways to prevent pressure ulcers in non-ambulatory patients and Team iDams who presented Eye(i) Drops Dispensing Aid and Monitoring Systems emerged as winners of the hackathon. “The focus of this hackathon is on geriatric healthcare and new innovations that would help improve the quality of life for senior citizens. Through this hackathon we intend to place selected participant in the technology business incubator which we have in association with the Government of Karnataka. Winners will therefore be able to take their products and services to the next level. The main objective is to stimulate and cultivate systemic innovation in the development of products for the Elderly Care and MedTech (Diagnostics, Monitoring and Rehabilitation)” said Prof. Amaresh Chakrabati – Chair, IISc Press Senior Professor and Chairman.  ReImagineHealth 2019 aims at providing technologically advanced and socially sustainable to the needs of the senior citizens so that they can continue to be independent, agile and enjoy their life to the fullest. “Through ReImagineHealth 2019, we have been able to radically change the field of geriatric healthcare with the use of new innovative technology to increase life expectancy amongst senior citizens with illnesses and ailments such as Dementia, Alzheimer’s, general debility and loss of memory. The goal is to attempt to give senior citizens a normal life. We have two hackathon series that we run with our partners, one is ReImagineHealth and the other is ReImagineWaste i.e. reutilizing waste in a different way and improve quality of life” he added. “The Technology Business Incubator at Centre for Product Design and Manufacturing is the Government of Karnataka’s initiative to encourage and support innovative technologies that drive affordable product solutions for geriatric care. The kind of response that ReImagineHealth Hackathon 2019 witnessed was overwhelming, especially from youngsters, in fact, one of the members of a winning team was a student of Class -9. This only shows the immense talent that is available to be tapped and nurtured.” said Dr. S Balasubramanya, Sr. Consultant (Biotech), KITS, Karnataka Dept. of IT, BT & S&T. ReImagineHealth is structured so as to address focal areas such as visual, aural, oral and dental, bowel and urinary issues along with their impact on mobility that hinder a senior citizen from having an active social life. ]]> https://biospectrumindia.com/news/97/14190/isic-becomes-first-hospital-outside-us-to-successfully-use-advanced-spine-robotics-system.html https://biospectrumindia.com/news/97/14190/isic-becomes-first-hospital-outside-us-to-successfully-use-advanced-spine-robotics-system.html Mon, 15 Jul 2019 16:00:00 +0530 The latest robotic system reduces implant inaccuracies, revision surgeries, radiation exposure, length of stay and infection, and combines advanced software, robotic technology, navigation and instrumentation along with artificial intelligence and sophisticated 3D analytics. Achieving a major milestone, the Indian Spinal Injuries Centre (ISIC), New Delhi has become the first hospital outside the US to add a highly advanced robotics system to its spine surgery capabilities. The hospital has already performed more than 5 successful precision surgeries using the recently acquired advanced Spine Robotics System. "Indian Spinal Injuries Centre is the first facility in the world after US to introduce the advanced Spine Robotic system. Surgeries conducted through advanced robotics reduce implant inaccuracies, revision surgeries, radiation exposure, length of stay and infection. Such high improvements in so many parameters simultaneously can drive significant clinical efficiency and reduce the burden on healthcare system in the medium to long run. It gives us immense pleasure to announce its induction in our system as this will help the doctors of ISIC serve the patients of spine injuries better and in a cost-effective manner,” says Dr. H S Chhabra, Medical Director Cum Chief of Spine Services, Indian Spinal Injuries Centre (ISIC), New Delhi. A team of spine surgeons led by Dr. H S Chhabra, Medical Director Cum Chief of Spine Services, Indian Spinal Injuries Centre (ISIC) successfully operated on Preeti Pandey, a 33-year old woman suffering from Post Tubercular Kyphotic Deformity. Preeti complained of severe progressive weakness of both lower limbs, inability to control bowel and bladder involvement and deformity of back. She was diagnosed with cervico-thoracic kyphosis due to the spinal tuberculosis where two procedures – robotic posterior stabilization, vertebra column resection, deformity correction and mesh cage insertion – were performed to correct her deformity and stabilize her movement.  She experienced minimum post-operative pain and started walking within a day. In another case, doctors performed a spinal fusion procedure on Satish Kumar, a 50-year man working in the Indian embassy at Beijing, China, who had developed low back pain radiating to the legs as well as heaviness in both the legs and was unable to walk more than 100 metres. He was diagnosed with spondylolisthesis, a spinal disorder in which a bone (vertebra) slips forward over the bone below it. The robotic minimal invasive Transforaminal Lumbar Inter body Fusion (TLIF) was performed with minimal incision and bleeding. Satish is significantly better after surgery and could walk up to 3 kilometers without any leg pain and with minimal post-operative pain within 3 days of surgery. Robotics is a recent advancement in spine surgery, a specialized approach to a complex procedure that allows planning a surgery and facilitates highly accurate and predictable execution of the plan. This robotic system combines advanced software, robotic technology, navigation, and instrumentation. The advanced software has deep artificial intelligence and sophisticated 3D analytics component. The latest generation robotics also has an infra-red camera that continuously tracks and navigates the movement of instruments and implants in relation to the patient anatomy and surgical plans. On the hardware front, the system uses a customized robotic arm that can perform extremely difficult maneuvering to enable complex procedures with high degree of precision. “Spine is one of the most important parts of the human body and performing a surgery on it is extremely delicate as even a minor error can cause severe, long-term consequences on the person which could be devastating. Hence, spine surgeons have to be extra careful about the methods they choose and are more than likely to opt for a technology that enhances their precision and ensures a better outcome. Those who are suffering from neck or back conditions can immensely benefit from the advanced technology that allows surgeons to perform less invasive surgical procedures with smaller incisions, less operative bleeding, faster recovery time and shorter hospital stays – it allows them to plan and create a blueprint for each surgical case. Serious medical complications such as complex cases of scoliosis and kyphosis, degenerative disc diseases, herniated discs, and spondylolisthesis can be successfully treated while those who are seeking a spinal fusion or revision surgery from failed prior surgery may also seek robot-guided assistance for the process,” says Dr. Chhabra. The technology allows surgeons to use images from a computerized tomography scan (CT scan) taken before surgery to create a blueprint for each case. These images are loaded into a computerized 3D planning system. In the operating room, surgeons do the physical surgery while the system guides his or her instruments based on pre-operative planning of spinal implant placement. During the surgery, the robot is placed near the patient either by attaching it to the bed or directly anchoring it to the spine of the patient.   ]]> https://biospectrumindia.com/news/97/14187/a-section-of-domestic-manufacturers-are-seeking-policy-intervention-based-on-flawed-data-interpretation-mtai.html https://biospectrumindia.com/news/97/14187/a-section-of-domestic-manufacturers-are-seeking-policy-intervention-based-on-flawed-data-interpretation-mtai.html Mon, 15 Jul 2019 15:00:00 +0530 Medical Technology Association of India (MTaI) has released a statement saying that the growth in imports of medical devices is being purposely exaggerated by a section of the domestic manufacturers to suit their agenda of seeking a hike in customs duty. This section of domestic manufacturers is presenting imports value of 2018-19 as being 25% higher than the previous year. The numbers are being presented in rupee terms, which is an erroneous measure as the value of rupee has depreciated sharply and therefore it does not present the correct picture. During the fiscal 2018-19, there was a sharp decline in INR to the extent of about 15% at its peak and if a full year’s average is considered, the rupee depreciated by 8.5% in fiscal 2018-19 over previous fiscal. Therefore, data in rupee terms is not comparable because of the effect of depreciating currency. One has to study the figures in US Dollar to deduce a logical conclusion. Let’s take a simple example: Suppose the imports have increased 10% from INR 1000 in 2017-18 to INR 1100 in 2018-19. During this period, actual data show that INR had depreciated from Rs. 65.31 a US Dollar to Rs. 70.82 a US Dollar. If one considers the imports in US$ terms based on the value of INR to a US Dollar, imports growth is 1.44% only. A look at the import data from Export-Import Data Bank on Department of Commerce’s website makes things amply clear. Imports under chapter 90 that contains all medical devices, grew 19.82% in 2018-19 from a year earlier when expressed in rupee terms. However, the corresponding growth in US$ terms was only 10.45%. Pavan Choudary, MTaI Chairman & Director General and Vygon India Managing Director said, “Besides repeatedly publicizing hazy data that can skew the narrative, fictitious figures are being presented as facts.” The section of domestic manufacturers claim that before implementation of GST, imports of medical devices attracted 18.5% taxes (including 7.5% customs duty, 6% countervailing duty and 4% special additional duties) and that after GST only 0-7.5% taxes are being paid by importers. Sanjay Bhutani, MTaI Director and Bausch and Lomb MD said, “The fact is after the GST regime, importers have to pay respective customs duty which is around 7.5%-10% in addition to 12% of GST. So in effect, importers are paying more taxes after GST regime than before. It is true that the input tax credit is applicable against GST component on inputs, but the same is available for locally manufactured goods as well. In total, GST regime does not benefit importers in any way over domestic players. In fact, post-GST import duties on many implantable devices have gone up to 10% due to increase in custom duties.” Considering these facts, the demand of a section of domestic manufacturers to increase customs duties on imported medical devices based on inexact interpretation of government data is specious. Pavan Choudary adds, “The saving grace is that such unrefined interpretations are not succeeding in distorting policy formulation. In fact, we are glad that the current government has for the first time constituted a National Medical Device Promotion Council to boost manufacturing, attract investments and promote exports. We hope this body will peer deep in to facts and come up with an irrefutable diagnosis and well considered prescriptions to catalyse make in India in patient and country interests.”   Higher custom duties would prove counterproductive by impacting the cost of medical devices which will ultimately pass on to the patient, which goes against the efforts of the government to provide affordable healthcare for all through pathbreaking policies like AB-PMJAY. Additionally, since the custom duty regime on most of the medical devices in several neighbouring countries are lower than in India, the difference in duties created could lead to the smuggling of the low-bulk-high-value devices. The result will not only be a loss of revenue for the government but the patients will also be beset with products which are not backed by adequate legal & service guarantees.   Probir Das, Director, MTaI said, “We must carefully note that China, even in segments like consumables where it has near self-sufficiency, has reduced their custom duties from 4 per cent to 3.3 per cent in 2017 for several products to avoid the problem of smuggling and to inject competition in the sector. Indian basic custom duty rate at 7.5% is clearly too high in the Asia-Pacific milieu and should be revised downward.”   The facts on the ground point to an advantageous situation for domestic manufacturers, whether local or global. The excise duty that was applicable on domestic manufactured goods got subsumed in GST. The GST imposition also gets balanced with the provision of input tax credit by the buyers of these goods. Badhri Iyengar, Director of MTaI and Managing Director of Smith & Nephew, India said, “The government should actually look at reducing import duties on medical devices especially spare parts and implantable devices.” The release also says, “This is more important now than ever before as the bottom lines of several companies importing medical devices have taken a hit of 14-19% because of multiple factors as enumerated below. The landing cost has increased between 10-15% due to INR devaluation. Inflationary trend as indicated by WPI of 4-5% has increased operational cost. Companies cannot increase the MRP of medical devices by more than 10% in a year. Therefore the companies have to absorb any increase in costs, affecting their bottom line. Kaustav Banerjee, Director, MTaI & MD Zimmer Biomet, India, said, “The GST Council should also reduce GST rate on medical devices from 12% to 5% besides notifying hospital services under Zero GST rate. This would reduce healthcare cost to patients as companies will supply the devices at lower cost and hospitals will be able to claim input tax credit.” At present hospitals are exempt from GST, which prevents imposition of GST on their services but at the same time prevents them from claiming input tax credit.   ]]> https://biospectrumindia.com/news/97/14159/roche-india-diagnostics-unveils-new-automated-solution.html https://biospectrumindia.com/news/97/14159/roche-india-diagnostics-unveils-new-automated-solution.html Wed, 10 Jul 2019 12:50:00 +0530 Roche Diagnostics India has announced the launch of its latest diagnostic technology - cobas® pro integrated solutions - which brings to India’s IVD labs an opportunity to establish several ‘first-of-its-kind’ features. This solution includes time-saving and efficiency-building features like automated maintenance and calibration and an on-the-fly reagent loading mechanism. Dr Shravan Subramanyam, Managing Director - Roche Diagnostics India, said, “Innovation to suit evolving lab and patient needs are at the heart of everything we do in Roche. I am excited about today’s launch of cobas pro in India because it addresses almost all of the challenges of today’s labs – reduced turnaround time, maintaining testing efficiency in limited space settings, less fatigue and improved productivity of lab personnel on account of automation and a single window into the industry’s largest test portfolio. With cobas pro integrated solutions, Roche Diagnostics India is equipped to partner with labs across the country to meet with their needs of tomorrow. That it can seamlessly integrate into Roche and other lab automation systems makes it attractive to lab management. It gives IVD labs an opportunity to experience the merits of digitalisation and automation, with the added benefit of Roche’s support in upskilling their technicians. I am excited that some of the sustainability matrices of cobas pro integrated solutions are most relevant to India’s needs. For instance, with cobas pro a lab uses one-third the amount of water required for a test in comparison to other analysers.” Dr. Benjamin Lilienfeld, International Business Leader, SWA Systems, Roche Diagnostics International said, “The cobas pro integrated solutions is Roche Diagnostics’ response to the needs of diagnostic labs and patients. The result is a revolutionary solution that offers greater automation, flexibility and a simplified workflow to support better clinical outcomes for patients. cobas pro represents Roche’s new generation of Serum Work Area solutions that endeavours to improve the speed and reliability of treatment decisions for patients and their families. They are designed to reduce the time between diagnosis and therapy management, and to instill greater confidence in clinical decision making. In tangible terms, cobas pro reduces daily maintenance time to 8 mins only, whilst it has a proven reduction ofup to 90 hours’ hands-on time for calibration every year (as compared to cobas 6000), significantly improving productivity of lab professionals. The ready-to-use reagents requiring no preparation time is another advantage for lab technicians to allocate their instrument and services time efficiently. We are delighted that our instruments are able to bring healthcare innovation to India.” cobas pro is available for diagnostic labs across India. ]]> https://biospectrumindia.com/news/97/14152/accutest-biologics-receives-oecd-glp-certification.html https://biospectrumindia.com/news/97/14152/accutest-biologics-receives-oecd-glp-certification.html Wed, 10 Jul 2019 09:00:00 +0530 Mumbai based Accutest Biologics Private Limited (ABPL), a leading CRO for high-quality Biochemical characterization and Bioanalytical services supporting preclinical and clinical development of Biologics and Biosimilars, has received the prestigious OECD-Good Laboratory Practice (GLP) certification. The said approval is the first in India for any independent laboratory without an animal house. The GLP Certification is in recognition of the high-quality, regulatorily compliant services rendered by Accutest in validating the processes and documentation systems followed at the test facility. "The certification places Accutest in a select league of CROs that have been awarded such a global honour. It is a matter of pride and privilege for Accutest not only to serve the biopharma industry with established credibility but also to get recognized in all the OECD member countries for mutual acceptance of data," commented Dr. Satish Sawant, Founder of Accutest.  "ABPL has been in existence for more than 5 years and conducted various studies for submissions across USFDA, EMA, DCGI and ANVISA. This approval will enable us to advance rapidly as a global service provider servicing the biopharmaceutical industry while maintaining high-quality deliverables," said Dr. Mallikarjun Dixit, President R&D and Test Facility Management at ABPL. ABPL is a subsidiary of Accutest Research Laboratories Pvt. Ltd., a well-established player in the Clinical CRO Industry for over two decades having dominant presence in Bio Availability and Bio Equivalence space with more than 100 International Accreditations. It is a state-of-the-art facility offering a one-stop solution for analytical and bioanalytical services from early-stage characterization to the late-stage clinical evaluation of biologics. Bioanalytical services include Pharmacokinetics, Pharmacodynamics and Immunogenicity assessment of Biologics, biotherapeutics, biosimilars, vaccines and non-biological complex drugs using high-end assay formats ELISA, MSD and GYROS. ABPL also provides in vitro activity/potency and bioassays services for evaluating the biological activity besides toxicokinetics and related services. ]]> https://biospectrumindia.com/news/97/14115/find-signs-14-5m-grant-with-unitaid-for-rapid-tb-diagnosis.html https://biospectrumindia.com/news/97/14115/find-signs-14-5m-grant-with-unitaid-for-rapid-tb-diagnosis.html Fri, 05 Jul 2019 10:35:00 +0530 The Foundation for Innovative New Diagnostics (FIND) has announced that a new $14.5 million grant has been signed with Unitaid to evaluate the use of next-generation sequencing (NGS) for diagnosis of drug-resistant tuberculosis (DR-TB) in low- and middle-income countries (LMICs). The grant agreement was signed by FIND CEO Catharina Boehme and Unitaid Executive Director Lelio Marmora, at the Global Health Campus in Geneva, Switzerland. The project – dubbed Seq&Treat (bringing next-generation TB care to underserved communities) – will start in October 2019. With implementation across Brazil, China, Georgia, India and South Africa over a period of 3 years, it will enable the introduction and global adoption of commercial, targeted NGS solutions for affordable, scalable and rapid TB drug susceptibility testing (DST). The Seq&Treat project seeks to generate clinical evidence to support World Health Organization (WHO) global guidance for the use of targeted NGS for DR-TB diagnosis, establish a WHO global clinical knowledgebase, evaluate proof-of-principle delivery models for integrating targeted NGS into existing diagnostic work streams, and facilitate inclusion of recommended NGS solutions into global procurement mechanisms and adoption by LMICs. “The implementation of sequencing for patient care in LMICs has been limited due to perceptions of high cost, technical and workflow complexity, and lack of infrastructure on both supply and demand sides,” said Catharina Boehme, CEO of FIND. “This significant investment from Unitaid will enable us to challenge these ideas by demonstrating sustainable and scalable sequencing models in high-burden TB countries.” “New technologies offer a phenomenal pathway to test and treat more people for tuberculosis, including drug-resistant TB, while strengthening health systems,” said Lelio Marmora, Executive Director of Unitaid. Seq&Treat will enable rapid diagnosis and comprehensive treatment guidance in the short term, as well as catalyze an eventual decrease in the transmission of DR-TB, and reductions in DR-TB incidence and prevalence. ]]> https://biospectrumindia.com/news/97/14108/transasia-bio-medicals-unveils-blood-donation-app-saviour.html https://biospectrumindia.com/news/97/14108/transasia-bio-medicals-unveils-blood-donation-app-saviour.html Thu, 04 Jul 2019 14:40:00 +0530 Transasia Bio-Medicals Ltd., India’s leading In-vitro Diagnostic Company, unveiled ‘SAVIOUR’, a location-based blood donation app that is available free to everyone. It is the first in India to be on both Google Play and App Store. The new app is likely to empower those who have the resources to acquire blood but lose out on timely help due to inadequate blood bank infrastructure. It connects patients to the nearest donors, and notifies the patient in real-time on the number of donors who accept the request. Additionally, it sends out notifications to the registered donors on the need for blood-based on their type. Reminders sent by the app, ensure that the donors do not forget about their commitment. Once a donation has been made, a donor is advised to not donate blood in the recovery period. At this time, the app goes into a precautionary dormant state, in order to ensure complete safety of the donor. Moreover, the app makes it very convenient for donors; they just need to check-in at the nearest hospital through the app, a step that helps save time and ensurecredibility. Donors are incentivized with personal goodwill points, based on the number of donations and lives saved. In his comments, Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals Ltd., said, “Blood donation saves millions of lives. The new app is another by Transasia in line with our mission since inception, to make healthcare affordable and address the limited access to quality medical infrastructure for the masses. As the name rightly connotes, ‘SAVIOUR’ has been developed with a vision to empower both donors and patients and to save them from unethical practices which have led to corruption and exploitation of the needy. We will invest heavily in the promotion of the new app to facilitate its widespread use and save as many lives as possible. I would like to thank my team for their efforts in developing this app and ensuring it addresses most gaps with existing alternatives. I urge the healthy youth of our nation to register onthe app as donors and share the light of their life.” According to WHO estimates, blood donation by 1% of the population is the minimum needed to meet a country’s basic blood requirements. In 2016-17, India’s blood collection fell 15% over the previous year, or 1.9 million units short of the 1% benchmark. The WHO norm, however, is based on global averages and does not take into account India-specific factors and disease burden. As per Industry reports, in 2016-17, over 6.57 lakh units of blood and its products were discarded. 50% ofthe wasted units was Plasma which has a longer shelf life as compared to whole blood and red blood cells that have to beused within 35 days. ]]> https://biospectrumindia.com/news/97/14057/promedica-aeh-form-alliance-to-conduct-clinical-trials-in-india.html https://biospectrumindia.com/news/97/14057/promedica-aeh-form-alliance-to-conduct-clinical-trials-in-india.html Tue, 02 Jul 2019 09:00:00 +0530 Promedica International (PMI) and Dr. Agarwal’s Eye Hospitals (AEH) have formed a new partnership to conduct clinical trials in India, which they announced at the OCTANe Ophthalmology Technology Summit. PMI and AEH emphasized that this alliance will enable them to collaboratively enroll and manage clinical studies in an expanded patient population, while conforming with global and FDA qualification standards and regulations. PMI, as a professional contract research organization based in the US, will lead in the design of studies that meet or exceed global Good Clinical Practice and medical quality standards. AEH, which is an international ophthalmic healthcare system, will provide clinical expertise and facility access in India. With its extensive background in clinical research, PMI offers services that include project management, study management and monitoring, data management, statistical services, clinical quality assurance, medical writing and global regulatory support. “For PMI, this partnership will initially augment our resources for enrollment and management of FDA clinical trials. At the same time, AEH gains the opportunity to significantly improve their quality and volume of clinical research with timely execution of studies,” said Shannon Stoddard, President/CEO of PMI. “Over the longer term, we believe this collaboration will enable both parties to build a global organization for conducting ophthalmic studies, and foster the development of proprietary models for multiple disease states,” said Ms. Stoddard. “AEH and PMI are a winning combination because we share complementary goals and a vision of how to best deliver on the promise of clinical research,” said Dr. Ashvin Agarwal, Executive Director, Chief of Clinical Services at AEH. “Dr. Agarwal’s Eye Hospitals welcomes the opportunity to work with PMI because of their success and the brand they have built performing their clinical study services on a global level.”   ]]> https://biospectrumindia.com/news/97/14069/iria-organises-indias-largest-conference-on-ultrasound.html https://biospectrumindia.com/news/97/14069/iria-organises-indias-largest-conference-on-ultrasound.html Mon, 01 Jul 2019 18:00:00 +0530 The ‘Indian Radiological & Imaging Association’ (IRIA), today announced the inauguration of SONO SUMMIT 2019, India’s largest International Ultrasound Conference at Chennai Trade Centre, Nandambakkam, Chennai. The conference was inaugurated by Hon’ble Member of Parliament Dr. Santanu Sen and National President of Indian Medical Association in the esteemed presence of Guest of Honour, Dr. Ulrike M Hamper, Director, John Hopkins University, USA, Dr. Hemant Patel, President, IRIA, Dr. Rajeev Singh, Secretary-General, IRIA and senior officials from healthcare sector to debate, discuss and explore several avenues in Radiology. The first-of-its-kind summit will host the talks of international faculties including Dr. Priyanka Jha from University of California San Francisco; Dr. Anil Ahuja, Professor of Diagnostic Radiology & Organ Imaging, Department of Imaging & Interventional Radiology, The Chinese University of Hong Kong; Dr. Ravi Devidas Kadasne, Specialist: Radiologist & Radiology, NMC Specialty Hospital, Al Ain and Dr. Girish Gandikota, Professor, Radiology & Rheumatology, Associate Program Director, Residency Program, Division of Musculoskeletal Radiology and many others. The main focus of SONO SUMMIT 2019 would be Sonography, aims at bringing together radiologists from across globe on one single platform, with an objective to take Sonography to the next level by increasing awareness, practical demonstration and productive sessions which provides a clear picture about the current trend and latest technologies in the sector. The summit will be guided by world’s renowned faculties in ultrasound which will not only enrich the delegates with their vast knowledge and experience but also provide the participants the best exposure and expertise. Commenting on the inaugural ceremony, Dr. Hemant Patel, President, IRIA, said, “We are proud to host this India’s largest ultrasound conference “SONO Summit 2019” in Chennai as India today exhibits exponential growth in healthcare sector and a summit such as this provides an opportunity to exchange ideas and knowledge, debate issues of real importance to the development of Sonography”. Dr. Rajeev Singh, Secretary General, IRIA, said, “This summit is specially designed by IRIA aims at giving impetus to the existing ultrasound practitioners especially the beginners by conducting workshops, live demos and interactive sessions etc. This summit is a part of an overall strategy of IRIA to increase awareness about the importance of Sonography, further strengthen and encourage new entities” This is India’s largest gathering of Ultrasound professionals, with an estimated 1300 professionals attending the conference during the four days. The summit will witness the participation of around 100 international delegates from across the globe. ]]> https://biospectrumindia.com/news/97/14015/essity-integrates-bsn-medical-india.html https://biospectrumindia.com/news/97/14015/essity-integrates-bsn-medical-india.html Thu, 27 Jun 2019 09:00:00 +0530 Global health and hygiene company, Essity, announced the final step in integrating BSN medical India into the Essity organization. Following the global acquisition of BSN medical in April 2017, the business in India continues its journey as Essity India, with a sharp focus on the medical and healthcare solutions market. Emerging markets, including India, accounted for 35% of Essity’s global net sales in 2018. Essity India, aims to further strengthen its market position across three key portfolios: orthopedics, wound care and compression therapy. Orthopedics: Solutions for fracture management, physiotherapy, orthopedic soft goods and braces Wound care: Solutions for acute and advanced wound care like surgical tapes, retention bandages, surgical/post-operation dressings, adhesive bandages/plasters Compression therapy: Phlebology and lymphology solutions like compression bandages, compression stockings, pneumatic compression pumps, etc. The three portfolios include heritage brands such as Delta-Cast, Actimove, Leukoplast, Cutimed and JOBST. Speaking on this final step in the integration and launch of Essity India, Neeraj Raghuvanshi, Managing Director, Essity India said, “We are pleased to bring the global heritage of Essity to India. Our goal for the next two years is to strengthen the existing business and attain strong growth for the company. With our integrated therapy solutions, backed by cutting edge technology, we hope to positively contribute to the healthcare needs of Indian patients.” In India, Essity will also work towards its global commitment to six key United Nations Sustainable Development Goals (UN SDGs), namely - Good health and well-being, Gender equality, Clean water and sanitation, Responsible consumption and production, Climate action and Life on land. Carl-Magnus Stensson, Vice President Sales & Marketing, Asia Pacific - Health and Medical Solutions, Essity said, “Through our business operations, domain expertise and partnerships with others who share the same challenges and opportunities, we continuously work towards creating synergies that contribute to the achievement of the UN SDGs.” “Sustainability is at the core of everything we do, and we hope to continue developing solutions through a sustainable approach. In India, our state-of-the-art manufacturing facilities in Goa, cater to the supply requirements of close to 60 countries, spanning across Asia-Pacific, Latin America and Africa. With the current expansion of our global legacy brands such as Leukoplast, Gypsona, Leukocrepe and the growing medical and healthcare needs of India, the country will continue to be a key regional business hub for Essity,” Stensson added. Recently, Essity was recognized in The Sustainability Yearbook 2019 for the Household Product industry and received the Gold Class and Industry Mover distinction for excellent sustainability performance, by RobecoSAM’s ranking. RobecoSAM is an investment specialist focused exclusively on Sustainability Investing and annually assesses the world’s largest companies for the Dow Jones Sustainability Index (DJSI), one of the world’s sustainability indices. The company’s India headquarters are located in Mumbai with an employee base of more than 200 people.     ]]> https://biospectrumindia.com/news/97/13991/usfda-to-increase-transparency-in-medical-device-reporting.html https://biospectrumindia.com/news/97/13991/usfda-to-increase-transparency-in-medical-device-reporting.html Mon, 24 Jun 2019 12:55:00 +0530 In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products. FDA has formally ended the Alternative Summary Reporting (ASR) Program. Under this program, manufacturers of certain devices could request an exemption from the requirement to file individual medical device reports for certain events that were well-known and well-established risks associated with a particular device and to instead submit quarterly summary reports of such events. Since the program’s inception in 1997, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to health care professionals and patients. The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks. Since 2017,  steps have been taken to gradually sunset the ASR Program and to streamline medical device reporting as FDA implemented the Voluntary Malfunction Summary Reporting (VMSR) Program. The VMSR Program reflects a pilot program conducted in response to changes made in the Food and Drug Administration Amendments Act of 2007 and goals agreed to as part of the Medical Device User Fee Amendments of 2017 (MDUFA IV) process. The FDA implemented the VMSR Program after conducting the pilot study that demonstrated the value of the program to public health. ]]> https://biospectrumindia.com/news/97/13988/parexel-launches-enhanced-integrated-outsourcing-delivery-model-for-fsp-.html https://biospectrumindia.com/news/97/13988/parexel-launches-enhanced-integrated-outsourcing-delivery-model-for-fsp-.html Mon, 24 Jun 2019 12:00:00 +0530 Parexel, a leading provider of solutions to accelerate the development and delivery of innovative new therapies to market to improve world health, from Clinical through to Commercialization has launched an enhanced integrated outsourcing delivery model for Functional Service Provider (FSP) services at the DIA 2019 Global Annual Meeting in San Diego. Parexel FSP reflects the company’s strategic focus on offering patient-focused customer solutions tailored to the changing needs of its biopharma customers, from full service to functional to a hybrid approach. Customers have access to multifunctional expertise and resources through a single point-of-contact while maintaining business continuity and productivity to drive efficiency, reduce complexity and accelerate time to market. “With functional services and related blended models representing a significant proportion of total clinical development spend today, biopharma companies need flexible and hybrid approaches to their outsourcing needs,” says Peyton Howell, Executive Vice President and Chief Commercial & Strategy Officer. “Parexel is an FSP ideal partner, with a proven track record in connecting and delivering targeted needs with increased expertise across functional services and an ability to integrate seamlessly with our customers’ teams.” Parexel is a pioneer in the development and delivery of a wide range of FSP, full service and flexible clinical development services, with more than 1,400 projects delivered. “Parexel is able to further leverage our ExecuPharm and TMAC (The Medical Affairs Company) subsidiaries — well-respected companies providing functional outsourcing in the biopharma space — with our broader FSP offering to provide a comprehensive FSP and hybrid capability unmatched in our industry,” notes Ms. Howell. “For example, our ExecuPharm subsidiary provides biopharma customers with qualified professionals across functional areas, including clinical monitoring and study management. TMAC provides strategic and tactical solutions, including contract field based medical teams, medical science liaisons, medical information and medical affairs consulting.” Parexel FSP consists of more than 5,000 specialized and dedicated employees across the globe with an industry-leading track record of achieving a 95 percent success rate in delivering repeat business. The company’s internal training and recruitment functions ensure FSP teams are trained quickly and integrate and align with the customer to deliver seamless support that drives business continuity. Both Parexel and its ExecuPharm subsidiary have been recognized by biopharma customers for their FSP services, with ExecuPharm winning multiple innovation and excellence awards during the past year and Parexel also being recognized with an innovation award for its FSP offering. Parexel’s customizable functional service solutions include Global Clinical Operations, Global Data Operations, Pharmacovigilance, Medical Affairs, Medical Writing, and Regulatory Support. Solutions leverage the company’s access to emerging markets and off-shore locations to drive cost efficiencies and a global resourcing pool and dedicated talent acquisition team for rapid resources ramp-up. Parexel leaders will be at Booth #1419 to discuss the Parexel FSP model and a range of other topics impacting clinical development today, including “Emerging Technologies in Clinical Research,” “Precision Medicines in Clinical Trials,” “Real World Data to Real World Evidence,” “Personalized Healthcare and Clinical Outcomes” and more. Parexel is focused on supporting the development of innovative new therapies to improve patient health.  ]]> https://biospectrumindia.com/news/97/13956/shimmer-with-clearsky-to-improve-analysis-of-wearable-sensor-data-.html https://biospectrumindia.com/news/97/13956/shimmer-with-clearsky-to-improve-analysis-of-wearable-sensor-data-.html Thu, 20 Jun 2019 15:05:00 +0530 Shimmer Research, a global leader in wearable technology for research applications, and ClearSky Medical Diagnostics, a leader in analyzing wearable data for medical applications announced they are partnering to bring a new level of analytic capabilities to the use of wearable sensors in clinical research. This partnership will employ Shimmer’s Verisense™ wearable sensors platform, which has been designed specifically for use in clinical research, with ClearSky algorithms and machine learning to transform wearables data into actionable insights for central nervous system (CNS) diseases.  Verisense is a comprehensive and flexible solution for reliably capturing accurate and complete biometric data. Worn on the wrist, the Verisense Inertial Measurement Unit (IMU) sensor can monitor activity and sleep seamlessly. But Verisense can be used for any IMU application with up to seven sensors worn on different parts of a participant’s body, making it invaluable for studying complex musculoskeletal or neurological conditions, such as dystonia or epilepsy.  ClearSky Medical Diagnostics specializes in developing technologies for the diagnosis and monitoring of Parkinson’s disease, Alzheimer’s disease and other neurodegenerative conditions. Its clinically-validated medical devices have been used in medical centers worldwide and in clinical trials to demonstrate the efficacy of new drugs. For example, ClearSky’s LID-Monitor can distinguish Levodopa-induced dyskinesia from Parkinson’s tremors, allowing doctors to optimize Levodopa dosage. This approach significantly improves patients’ quality of life and also saves time and money due to the reduction in consultations required. ClearSky’s technical team has more than 15 years’ experience analyzing clinical trial data and has developed a range of machine learning technologies to meet current and future clinical needs.  “The Verisense platform is truly a breakthrough for conducting clinical research,” said Dr. Stephen Smith, co-founder of ClearSky Medical Diagnostics. “It can provide the continuous raw data from wearables needed for sophisticated algorithms, yet places almost no burden on the participant or the clinical site. It has multiple layers of redundancy and quality checking to ensure that high-quality data are collected without interruption.”  “Literally thousands of researchers have been using Shimmer sensors for more than 10 years to develop algorithms to understand the data from wearable sensors,” said Gill. “By capturing continuous raw data, the Verisense platform allows us to leverage tens of thousands of person-years of research. We anticipate collaborating with many leading researchers and are excited that ClearSky shares our vision.” ]]> https://biospectrumindia.com/news/97/13933/abbott-launches-hba1c-test-to-aid-in-diagnosis-of-diabetes-.html https://biospectrumindia.com/news/97/13933/abbott-launches-hba1c-test-to-aid-in-diagnosis-of-diabetes-.html Tue, 18 Jun 2019 15:25:00 +0530 Abbott has announced that its Afinion™ HbA1c Dx assay is now available for use on the Afinion 2 Analyzer, as well as the Afinion AS100 Analyzer. The Afinion HbA1c Dx assay is the first and only rapid point-of-care test cleared by the U.S. Food and Drug Administration (FDA) to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients' risk of developing the condition. The Afinion HbA1c Dx meets FDA's stringent requirements for performance testing for diagnostic use claims. The test delivers accurate and precise, glycated hemoglobin (HbA1c) results in only three minutes, enabling clinicians to diagnose patients and help them formulate individualized care plans during a single doctor's office visit. The Afinion HbA1c Dx assay (approved for monitoring and diagnosis) complements the Afinion HbA1c assay (approved for monitoring only), the number one point-of-care HbA1c test in the U.S. for monitoring long-term glycemic control in diabetes. Elizabeth Balthrop, divisional vice president, Cardiometabolic and Informatics, Rapid Diagnostics, Abbott said, "As diagnostics continue to move to point-of-care settings such as physician office labs, the Afinion HbA1c Dx rapid assay shows how Abbott is once again setting new standards for innovation in the diagnosis and monitoring of diabetes. In addition to giving physicians the certainty of diagnosis they need to make informed decisions during a patient visit, the HbA1c Dx assay gives people living with diabetes near real-time results, so that in consultation with their doctor they can make adjustments to their lifestyle and better manage their condition." Richard Kahn, Ph.D., former chief scientific and medical officer of the American Diabetes Association said, "Rapid, reliable diabetes screening at the point of care enables healthcare providers to immediately link patients to comprehensive care that can help prevent the serious consequences of the disease. In addition, point-of-care diagnosis can enhance clinical efficiencies for busy practices and, at a population level, help stem the massive economic and societal impacts of diabetes in the U.S." The Afinion HbA1c Dx assay is FDA-cleared as a moderate complexity test for quantitative determination of HbA1c in human whole blood, used to aid in the diagnosis of diabetes and assessment of patients' risk of developing the disease. It is also cleared for use in monitoring long-term glycemic control. The assay received FDA clearance for use on the Afinion AS100 Analyzer in May 2018. The Afinion 2 Analyzer is a state-of-the-art multi-assay platform that streamlines and simplifies the delivery of actionable, accurate measurements of HbA1c and ACR (albumin-to-creatinine ratio) results at the point of care. The system arms healthcare professionals with the information needed to make fast and accurate medical decisions. The Afinion 2 platform, which offers all-in-one connectivity to LIS/HIS (laboratory and hospital information systems) and a sleeker, quieter experience for clinicians and patients, was launched in May 2018 for patient management of diabetes through whole blood HbA1c testing and ACR testing in urine.   ]]> https://biospectrumindia.com/news/97/13869/abbott-launches-advanced-mapping-catheter-in-india.html https://biospectrumindia.com/news/97/13869/abbott-launches-advanced-mapping-catheter-in-india.html Tue, 11 Jun 2019 17:05:00 +0530 Abbott has announced the launch of its HD grid mapping catheter, which is sensor enabled in India. This product received USFDA clearance last year in May. The catheter employs a new design that allows physicians to see things differently, capturing and analyzing data in a novel manner to create highly detailed maps of the heart that better differentiate healthy from unhealthy tissue. The new mapping catheter builds upon Abbott’s innovative products designed to improve how physicians perform cardiac ablation procedures, including cardiac mapping systems and treatment catheters. Arrhythmias are abnormal heart rhythms caused by improperly conducted electrical signals in the heart. Abnormal heart rhythms, which include conditions such as atrial fibrillation, make the heart beat too fast, too slow or out of sync. In each case, the heart may pump blood less effectively which can cause a range of symptoms that disrupt a patient's quality of life. In some cases, cardiac arrhythmias can damage the heart or cause blood clots, strokes or cardiac arrest. For people battling complex arrhythmias, physicians may use cardiac ablation therapy to create lesions on the heart to disrupt the electrical pathways causing the erratic heart beats. To ensure the best outcomes for their patients, physicians first need to identify which areas of the heart contain those pathways. Mapping catheters are critical to providing this insight — delivering an inside view of the heart so physicians can navigate cardiac anatomy to deliver more precise ablation therapy. The new catheter from Abbott is designed to capture information — such as the direction and speed of cardiac signals — often missed with traditional mapping catheters. It offers physicians a unique grid configuration that captures this critical information and enables the creation of high-density maps of cardiac tissue to support optimal treatment for patients. With this grid mapping catheter, for the first-time physicians can see electrical signals that they may have missed using standard mapping catheters. Dr Eric T.S. Lim, Consultant Electrophysiology and General Cardiology at the National Heart center, Singapore, on a visit to India said, "It is very important to better understand and redefine arrhythmia mechanisms with higher resolution cardiac mapping. This catheter represents an important step in the development of next generation mapping catheters. With a flexible and soft design using high density, closely spaced grid configuration and magnetic sensor technology, the catheter helps capture signals previous catheters may have missed to support the creation of highly detailed 3D maps of the heart.” Dr Balbir Singh, Chairman Interventional Cardiology and Chairman Electrophysiology & Pacing, Medanta, the Medicity Hospital, Gurgaon adds, "Innovation within the field of electrophysiology continues to evolve toward improving our ability to visualize arrhythmias in much greater detail, and we are confident that patient outcomes will improve as a result." Dr. Ulhas M. Pandurangi, Chief - Cardiac Electrophysiology and Pacing, The Madras Medical Mission, Chennai says, "Innovation within the field of electrophysiology is essential. Unique mapping technology offers the opportunity to discover issues not otherwise visible. This leads to more accurate mapping of the heart, thereby enabling more effective therapy." Launch of this product has further expanded Abbott's comprehensive portfolio of mapping and treatment catheters. Combined, the portfolio has helped improve how physicians approach the treatment of complex arrhythmias and atrial fibrillation and introduced a new level of innovation into the electrophysiology market. This catheter has been used in 20 countries since its European launch, and in the US since its USFDA approval last year.     ]]> https://biospectrumindia.com/news/97/13863/jubilant-gets-ce-mark-for-its-medical-device-and-consumable-accessories.html https://biospectrumindia.com/news/97/13863/jubilant-gets-ce-mark-for-its-medical-device-and-consumable-accessories.html Tue, 11 Jun 2019 12:25:00 +0530 Jubilant DraxImage Inc. ("DraxImage"), a wholly owned subsidiary of Jubilant Pharma Limited, is pleased to announce the receipt of the CE Mark certificate for its state-of-the-art RUBY Rubidium Elution System (RbES) and the proprietary RUBY consumable accessories dedicated for use with their RUBY-FILL®(Rubidium Rb82 Generator). This certificate allows the device to be distributed into the European Economic Area (EEA).   The RUBY-FILL® Generator and the RUBY Rubidium Elution System provide the latest technology in Positron Emission Tomography (PET) Myocardial Imaging. RUBY-FILL® is a closed system used to produce personalized patient doses of rubidium (Rb82) chloride injection for intravenous use. Rb82 chloride injection is a radioactive diagnostic agent indicated for PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. Jubilant Pharma Senior Vice-President of Medical and Chief Medical Officer Dr. Norman LaFrancestated, "Jubilant DraxImage is extremely excited about the CE Mark certificate, which will provide expanded access of this next-generation PET product into the EEA. With its advanced weight-based dosing accuracy and infusion options, RUBY-FILL will enhance the way patients with known or suspected coronary artery disease are both diagnosed and managed."  "This approval is another landmark event for Jubilant DraxImage, supporting its ongoing commitment to the global expansion and utility of nuclear medicine and PET imaging. Our goal is to grow SPECT and PET imaging globally by providing products that enable physicians to deliver high-quality diagnostic studies as part of our mission of Improving Lives Through Nuclear Medicine," stated Pramod Yadav, CEO Jubilant Pharma LTD. ]]> https://biospectrumindia.com/news/97/13832/merils-myval-transcatheter-heart-valve-receives-ce-approval.html https://biospectrumindia.com/news/97/13832/merils-myval-transcatheter-heart-valve-receives-ce-approval.html Mon, 10 Jun 2019 09:00:00 +0530 Recently, MyvalTM received the coveted CE approval. Meril now becomes the first Indian company to market and distribute its indigenously designed and patented TAVR technology, MyvalTM -THV system, to European Union and other countries. The CE certification is a conformity mark indicating the product to be compliant with the European Union (EU) health standards. The CE certification would enable MyvalTM -THV to reach over 60 countries in Europe and outside of India which accept CE mark document for their own regulatory approvals. TAVR is an established treatment modality for patients who are at a risk or unwilling to undergo open heart valve replacement surgery. TAVR is a minimally invasive procedure that repairs the aortic heart valve without removing the old, damaged valve. Instead, it places a replacement valve through a catheter or tube inserted through the femoral artery (the large artery in the groin). The TAVR procedure is also beneficial for treating patients with previous failed bioprosthetic valve, hence preventing an additional surgical intervention.  The MyvalTM THV System has a Hybrid honey comb design, on crimping it has a distinct alternating dark-light banding pattern visible under fluoroscopy. This unique pattern helps in precise placement of the valve and ensures orthotopic deployment. MyvalTM THV gets crimped on a Navigator delivery system which comes with a dual-stopper system ensuring valve crimping is precise and snug. The MyvalTM System includes Mammoth balloon dilatation catheter, 9F low profile, for valvuloplasty. The kit also includes atraumatic and lubricious coated Python introducer sheath, 14F low Profile which allows for percutaneous access of the crimped MyvalTM THV. Meril Life Sciences got CE and Central Drugs Standard Control Organization (CDSCO) approval for MyvalTM technology basis the results of MyVal-1 Study. One-year clinical outcomes from the MyVal-1 study demonstrated 100% acute procedural success and no device-related mortality as reported at EuroPCR 2019 (21-24 May). The data were presented in a Late-breaking trial session at EuroPCR’2019 Conference at Paris by the trial’s Principal investigator, Dr Ashok Seth, Chairman of Fortis Escorts Heart Institute, New Delhi, India. Dr Seth explained that in addition to the procedural success and zero device-related mortality rate, there were also no new pacemaker implantations, no strokes and no paravalvular leaks observed in the trial patients. Furthermore, Echo parameters were maintained at 12-month follow-up and there was a significant improvement in Quality of Life of the patients as demonstrated by tests including NYHA functional class. Sanjeev Bhatt, Vice President Corporate Strategy, Meril Life Sciences said, "We are excited by these results. Since its inception, Meril has played a leading role in developing and introducing innovative medical technologies. Our MyvalTM Transcatheter Heart Valve technology is an assertion of this fundamental belief and after being granted the CE mark, we get set to launch it across Europe. It’s a proud moment not just for us but for India to be able to make this indigenous innovation available globally." Meril is a global medical device company operating in more than 100 countries with a diverse operational canvas from Vascular Interventional devices to Orthopedics, In-vitro diagnostics and Endo-Surgery.   ]]> https://biospectrumindia.com/news/97/13786/path-quansys-bio-develop-new-diagnostic-tool-for-malaria.html https://biospectrumindia.com/news/97/13786/path-quansys-bio-develop-new-diagnostic-tool-for-malaria.html Mon, 03 Jun 2019 12:50:00 +0530 PATH and Quansys Biosciences, Inc. have announced the launch of a new diagnostic tool designed to help researchers develop more sensitive and reliable malaria rapid diagnostic tests (RDTs) and to support public health surveillance. The Q-Plex™ Human Malaria Array (5-Plex) is a quantitative immunoassay that simultaneously measures multiple malaria antigens. Many current RDTs function by detecting the histidine rich protein 2 (HRP2) to identify P. falciparum malaria and the Plasmodium lactate dehydrogenase (pLDH) antigen to diagnose P. vivax malaria and all other human malaria species. As RDTs improve in quality, there is a need to understand how these antigens behave in a malaria exposed population so that the performance of these RDTs and their potential to support malaria elimination can be fully assessed. With a single sample, the Q-Plex™ Human Malaria Array can measure HRP2 and pLDH at low concentrations, as well as quantify P. vivax- and P. falciparum-specific LDH epitopes to distinguish between malaria species and C-reactive protein (CRP) as an indicator of inflammation. Researchers can use the Q-Plex™ Human Malaria Array (5-Plex) as a reference test to evaluate RDTs in the development pipeline that detect malaria infections with low parasite concentrations and address the challenge of diagnosing P. falciparum malaria parasite strains that do not produce HRP2 and therefore are not detected by RDTs designed to identify the antigen. ]]> https://biospectrumindia.com/news/97/13769/bayer-to-develop-ngs-based-companion-diagnostics-in-oncology.html https://biospectrumindia.com/news/97/13769/bayer-to-develop-ngs-based-companion-diagnostics-in-oncology.html Fri, 31 May 2019 10:50:00 +0530 Bayer AG and Foundation Medicine, Inc. have announced a global collaboration for the development and commercialization of NGS-based companion diagnostics. This agreement allows for collaboration across multiple oncology drug candidates and approved therapies developed by Bayer and covers Foundation Medicine’s full portfolio of tests, including FoundationOne®CDx. The first project will be to develop a companion diagnostic for larotrectinib, the first and only TRK inhibitor approved in the U.S. for patients with TRK fusion cancer across all solid tumors. NGS-based companion diagnostic tests aim to unlock molecular information from each patient’s tumor genome to guide treatment decisions for cancer therapies. FoundationOne®CDx is the first FDA-approved broad companion diagnostic for all solid tumors.  ]]> https://biospectrumindia.com/news/97/13768/apollo-hospital-brings-new-level-of-precision-to-pet-ct-imaging.html https://biospectrumindia.com/news/97/13768/apollo-hospital-brings-new-level-of-precision-to-pet-ct-imaging.html Fri, 31 May 2019 10:40:00 +0530 With nearly a million new cancer cases diagnosed per annum in India, staging disease more accurately and defining treatment strategies better is the need of the hour. With the introduction of Biograph Vision™ in India, addressing cancer progression with personalized medicine will help deliver the right treatment to the right patient and at the right time. PET/CT is indispensable as a diagnostic and prognostic tool in the assessment of patient response to cancer therapy and cancer recurrence. The Biograph Vision™ from Siemens Healthineers enables a better understanding of disease progression and treatment resistance, to define treatments that can be precisely tailored for patients. “Biograph Vision™ is designed for improved accuracy, performance, and reproducibility to deliver a whole new world of precision in PET/CT imaging. With the market’s fastest time-of-flight and highest effective sensitivity, Biograph Vision™ helps reduce scan time and injected dose, reducing patient exposure to radiation. With the introduction of Biograph Vision™ Siemens Healthineers is helping Apollo Proton Cancer Centre in Chennai to enhance the quality of patient care and expand precison medicine.” said, Mr. Vivek Kanade, Executive Director, Siemens Healthineers, India. Dr. Prathap C Reddy, Chairman, Apollo Hospitals Group said, “Our patient centric ethos has always motivated us to invest in the best available for our patients and Apollo has been at the forefront of introducing cutting edge technologies in India and the region. Apollo Proton Cancer Centre in Chennai has ushered new hope for over 3.5 billion people, who earlier would have had to travel to the western world to access Proton Therapy, the world’s most advanced radiation therapy.  Increasingly Proton Therapy is becoming the standard of care for several cancers and its unique edge of minimal side effects is transforming quality of cancer survivorship.” Speaking about the benefits, Ms. Suneeta Reddy, Managing Director, Apollo Hospitals added, “The DNA of Apollo Hospitals is clinical excellence and achieving clinical outcomes on par with the world’s best centres. Each of our investments including the Siemens Healthineers’ Biograph Vision™ at our new Apollo Proton Cancer Centre underscores this spirit and commitment to provide an international standard of care for our patients. “ Unique advances in Biograph Vision™ offer an opportunity to manage dose reduction, reduce scan time, and more accurately detect small lesions.  Finally, it leads to increased accuracy of diagnosis, improves system performance, and helps clinicians understand disease progress by improving reproducibility in quantification, benefitting patients with precision medicine. Innovation in Digital PET/CT with Ultra Dynamic Range (UDR) detector technology brings clinicians vast improvements in system sensitivity due to the improvement of Time-of-Flight technology, volumetric resolution by using small (3.2 mm x 3.2 mm) LSO crystals and qualitative accuracy. With the market’s fastest time-of-flight at 214 ps and the highest effective sensitivity at 100 cps/kBq, Biograph Vision™ helps to reduce scan time by a factor of 3.9 to improve patient throughput as well as reduce patient radiation exposure and tracer cost. Improved patient comfort and positioning as well as advanced applications in radiation therapy planning is enabled through the system’s 78 cm bore. Biograph Vision™ is also designed to reduce unnecessary exposure to CT radiation, provide greater patient comfort and decreased examination time, thereby sparing patients from harmful side effects. ]]> https://biospectrumindia.com/news/97/13760/cepheid-gets-fda-nod-for-xpert-ct-ng-test.html https://biospectrumindia.com/news/97/13760/cepheid-gets-fda-nod-for-xpert-ct-ng-test.html Thu, 30 May 2019 14:00:00 +0530 Cepheid announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for testing throat and rectal specimens with its Xpert® CT/NG test. The test provides fast and accurate molecular detection of chlamydia and gonorrhea, making same-day consultation and treatment possible.  Xpert CT/NG test is an automated in vitro diagnostic test for qualitative detection and differentiation of DNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae. In addition to the new extragenital specimens, Xpert CT/NG is indicated for use with urine, vaginal, and endocervical specimens from symptomatic and asymptomatic patients. "Xpert CT/NG is the most sophisticated test in its class, yet it can be performed on-demand by virtually any laboratory to maximize the medical impact of the results.  Adding throat and rectal sample types addresses a critical unmet need allowing for more complete patient screening," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.  "Considering the increasing rates of chlamydial and gonorrheal infection, this is particularly important for public health screening programs, to capture patients who previously would have gone undiagnosed if only genital specimens were tested.It is not uncommon for patients to have an infection only in their throat or rectum, which may be asymptomatic. Same day consultation and treatment is critical for patient management so patients are not lost to follow up." The Xpert CT/NG test is performed on the Cepheid GeneXpert® Systems.  The test's capability to detect DNA from organisms in both genital and extragenital specimens allows for improved screening and detection in patients to ensure infections can be treated in the same day.  ]]> https://biospectrumindia.com/news/97/13723/qco-to-raise-cost-without-covering-all-aspects-of-patient-safety-mtai.html https://biospectrumindia.com/news/97/13723/qco-to-raise-cost-without-covering-all-aspects-of-patient-safety-mtai.html Tue, 28 May 2019 09:00:00 +0530 Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies having a large footprint in manufacturing, R&D and training in India, has said QCO Orders for medical device regulation do not fit in government’s broader plan to ensure patient safety or lower cost of healthcare.   Bureau of Indian Standards (BIS) through Department of pharmaceuticals (DoP) is in the process of finalising a quality control mechanism for medical devices. It had issued a draft Quality Control Orders (QCO) for six categories of devices including blood glucose monitoring system, surgical blades, gloves, and clinical electric thermometer, seeking stakeholder views. MTaI has submitted its inputs to the government.   “The proposed Quality Control Orders has a limited scope as it does not adequately address all aspects of quality, safety and performance and only covers the product safety standard of medical devices. Conforming to the order would mean increase in compliance cost for companies that are already adhering to essential checklist requirements of CDSCO or USFDA/CE norms as well as for domestic companies looking to export, since products must first conform with BIS standards, then qualify for global ISO/IES standards and then go for CE/ USFDA for eligibility for global markets” said MTaI   The Central Drugs Standard Control Organisation (CDSCO), which is the present regulatory authority for medical devices, certifies a device for usage after a rigorous process of evaluation which includes conformity with standards, real time clinical data on efficacy, safety and performance of the device.   CDSCO has already embarked on regulating all medical devices under Drugs & Cosmetic Act as well as under the provisions of newly introduced Medical Device Rules 2017, in a phase-wise manner.  A separate vertical consisting of medical device specialists is also being set up for this purpose. “There is duplication in what CDSCO and the Quality Control Orders seek to do which will lead to multiplicity of authorities as well as increase red tape for medical devices. While our demand for having a separate Act for regulation of medical device remain, we feel CDSCO should continue taking the lead in regulating the sector as it has the maximum expertise and experience in governing the medical device universe,” MTaI statement added.   At present only 37 medical devices are regulated. CDSCO has proposed a regulatory road map, which aims at bringing all categories of medical devices under regulation over a span of 4-5 years. As per the roadmap, all devices needs to be registered with CDSCO in the first phase of 12-18 months and then detailed due diligence of the devices will be carried out in the next 2-3 years. The proposal has already been approved by the Drug Technical Advisory Board (DTAB) which is the highest statutory decision-making body on technical matters related to Drugs in the country.     ]]> https://biospectrumindia.com/news/97/13715/fda-approves-diagnostic-tests-for-chlamydia-and-gonorrhoea.html https://biospectrumindia.com/news/97/13715/fda-approves-diagnostic-tests-for-chlamydia-and-gonorrhoea.html Fri, 24 May 2019 16:00:00 +0530 The U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted infections, respectively, chlamydia and gonorrhea, through diagnostic testing of extragenital specimens. The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum. These tests were previously only cleared for testing urine, vaginal and endocervical samples. The FDA granted clearance of Aptima Combo 2 Assay to Hologic, Inc. The FDA granted clearance of the Xpert CT/NG to Cepheid. In its evaluation of the devices, the FDA reviewed clinical data collected through a cross-sectional study coordinated by the Antibacterial Resistance Leadership Group, which is funded and supported by the National Institute of Allergy and Infectious Diseases. The study was a collaborative, multi-site clinical study of more than 2,500 patients that evaluated the diagnostic accuracy of multiple commercially available nucleic acid amplification tests for detection of Neisseria gonorrhoeae and Chlamydia trachomatis from throat and rectal sites. The results of this study, along with other information reviewed by the FDA, demonstrated that the Aptima Combo 2 Assay and the Xpert CT/NG for extragenital specimens are safe and effective for extragenital testing for chlamydia and gonorrhea. ]]> https://biospectrumindia.com/news/97/13680/medtronic-launches-telescope-guide-extension-catheter-.html https://biospectrumindia.com/news/97/13680/medtronic-launches-telescope-guide-extension-catheter-.html Mon, 20 May 2019 16:20:00 +0530 Medtronic plc, a global leader in percutaneous coronary intervention (PCI) innovation, today announced its entrance into the guide extension catheter market with the global launch of the Telescope(TM) Guide Extension Catheter, a newly designed catheter used to provide additional backup support and access to distal lesions. Guide extension catheters help deliver coronary stents, balloons and other interventional devices during angioplasty procedures that help to restore blood flow through the coronary and peripheral arteries. Developed alongside interventional cardiologists, many of whom are increasingly challenged with complex cases - such as patients with tortuous anatomies, calcified vessels, and distal lesions - the Telescope guide extension catheter provides operators with superior deliverability1 and is designed to enable smooth delivery of interventional devices in more challenging cases. "It is not an exaggeration to say that guide extension technologies have greatly impacted the ability to deliver devices to the distal coronary vasculature, especially for cases where traditional guide support may be limited," said Ajay Kirtane, M.D., S.M., director of the NewYork-Presbyterian Hospital/Columbia University Cardiac Catheterization Laboratories. "In this light, the Telescope - a guide extension catheter with specific design optimizations aiming to stably deliver devices through tortuous anatomy - is a welcome addition to the interventional toolbox." The Telescope guide extension catheter combines a solid, round pushwire with a coil-reinforced hydrophilic-coated distal segment to help physicians reach challenging lesions with improved pushability and deliverability.2 Telescope also features a flexible TruFlex(TM) soft polymer tip, which is designed to responsively bend and deflect during use. In addition, once Telescope is in position near the target lesion, SmoothPass technology helps to smoothly channel stents, balloons, and other interventional devices into place. "Before bringing this important technology to market, we collaborated with more than 700 interventional cardiologists to ensure Telescope was addressing unmet needs in complex PCI," said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. "We will continue to make investments in cutting edge interventional technologies, clinical evidence expansion, and robust physician training programs, which we believe will make a meaningful difference for physicians and their patients." In addition to the Telescope guide extension catheter, Medtronic's market-leading coronary portfolio includes the latest-generation Resolute Onyx(TM) Drug-Eluting Stent (DES), the Euphora(TM) line of pre- and post-dilatation balloon catheters, and a full suite of catheters including the DxTerity(TM) TRA Diagnostic Catheter and market-leading Launcher® Guide Catheter, all of which are commercially available in the U.S., as well as throughout Europe. ]]> https://biospectrumindia.com/news/97/13670/ge-healthcare-indi-molecular-to-develop-diagnostic-tool-for-immunotherapy-patients.html https://biospectrumindia.com/news/97/13670/ge-healthcare-indi-molecular-to-develop-diagnostic-tool-for-immunotherapy-patients.html Mon, 20 May 2019 10:40:00 +0530 GE Healthcare and Indi Molecular, Inc, a  California-based biotechnology company, have announced plans to develop immune cell-targeted Positron-Emission Tomography (PET) tracer candidates, based on Indi Molecular’s proprietary Protein Catalyzed Capture (PCC) technology. These tracer candidates, if successful, could help identify molecular markers of cytotoxic T-cells, and potentially help in the selection and monitoring of immunotherapy patients. “This collaboration is a credit to the strength of both our respective Research & Development teams,” said Albert A. Luderer, Ph.D., Indi Molecular CEO and co-founder. “We believe that our protein catalysed capture technology platform is ideally suited to deliver predictable, small molecule-like biological behaviour that possesses unique, ultra-high target affinity and specificity required for targets such as immune cells.”    GE Healthcare is a leading medtech and diagnostics innovator supporting an ecosystem striving for precision health. Within precision diagnostics, the company is building a portfolio of PET tracers targeting biomarkers for immunotherapies.    “Our developed PET tracers are already being used globally to support clinical trials of therapeutics,” said Julia Casey, General Manager of Molecular Imaging at GE Healthcare. “With Indi Molecular as one of our collaborators we can now begin to develop novel PET tracers for a variety of biomarkers of interest in the immuno-oncology space. These tracers could potentially play a critical role in supporting the development of immunotherapies, treatments that have shown great promise in how we manage oncology patients today.”   ]]> https://biospectrumindia.com/news/97/13667/apollo-hospitals-scripts-new-era-in-cardiac-care.html https://biospectrumindia.com/news/97/13667/apollo-hospitals-scripts-new-era-in-cardiac-care.html Mon, 20 May 2019 09:00:00 +0530 Apollo Hospitals Enterprise Ltd. (AHEL), Asia’s largest and most trusted multi-specialty chain of hospitals, recently showcased the group’s prowess in cardiac care in the largest cohort of cases treated with advanced cardiac interventional methods. These include three key innovations – MitraClip, TAVI (Trans-catheter Aortic Valve Implantation) or TAVR (Trans-catheter Aortic Valve Replacement) and MICS CABG or MICAS (Minimally Invasive Coronary Artery Bypass Surgery). Specialists in structural and interventional cardiology at Apollo Hopsitals have successfully performed 6 MitraClip procedures out of the 9 performed in India, over 85 TAVI/TAVRs with excellent clinical outcomes and a nation-leading 1250+ MICS CABGs with superior outcomes at par with international standards, at only 1/2 or 1/3rd the cost compared to global price matrix. Emphasizing Apollo Hospitals’ pioneering position in bringing the cutting edge of medical technology to India, Dr Prathap C Reddy, Founder and Chairman, Apollo Hospitals Group said, "Globally, an estimated 17 million people die of cardiovascular disease every year. Today, we have the power of technology and we must harness this to empower us in the battle against this epidemic of heart disease. In line with our mission to bring healthcare of International standards within the reach of every individual, we have also been a pioneer in the field of cardiac care, and it is our constant endeavor to get the latest technology to benefit our patients. We are indeed proud to showcase our achievements in bringing futuristic cardiac care with state of the art medical technology to the country. Over the years Apollo Hospitals has established itself as home to the largest cardiac practice in India, and I am no doubt that today we are not just the largest, but the most advanced!” Ms. Sangita Reddy, Joint Managing Director, Apollo Hospitals Group said, “The need of the hour is to have a robust scientific approach to identify the challenges in India in dealing with the patients affected with cardiac disease. This allows us to work towards a future where cardiovascular care is population-based, weighing cost and outcomes, but individually tailored and thoroughly coordinated around patients. Today, the role of technology in healthcare is as inseparable as a shadow to a body. Our services are designed to give more control, choices, and knowledge to patients. Technology can enable better access to medical care, lower costs of healthcare delivery and enhance the clinical outcome. We firmly believe that adoption of technological innovations is the fundamental enabler for future care delivery focused on pinpointing initiatives to enhance clinical and patient experience. With our prowess in harnessing cutting edge technology, we at Apollo Hospitals are committed to deliver best in cardiac care to our patients in India and around the globe” Elaborating on the modern techniques in interventional cardiology, Dr. Sai Satish, Senior Interventional Cardiologist, Apollo Hospitals said, “Apollo Hospitals is constantly striving to bring the latest advanced therapies for patients in India. These include the newer structural interventions including MitraClip and TAVI/TAVR which allow many patients with severe cardiac risks who cannot undergo surgery to benefit from minimally invasive therapies. The newer advancements in technology gives us the tools to add years to life - and life to years - of a patient. No one is never too old, thanks to technology.” Dr. Sengottuvelu G., Senior Consultant and Interventional Cardiologist said, “Apollo Hospitals is constantly striving to bring the latest advanced therapies for patients in India and is uniquely placed as the academic TAVR centre of excellence with many milestone achievements. Transcatheter Aortic Valve Replacement (TAVR), also known as Transcatheter Aortic Valve Implantation (TAVI) is the most cutting edge procedure being conducted at Apollo Hospitals, and allows a cardiologist to replace a malfunctioning valve in a patient’s heart in a minimally invasive procedure without cutting open the chest. It is a promising alternative to open heart surgery giving elderly patients a second chance at life.” Dr. Srinivas Kumar A, Cardiologist, Apollo Hospitals, Hyderabad and Director of National Interventional Council said, “In 2018, Apollo Hospitals performed the largest number of coronary interventions with 19681 patients treated which at 4.49% was the highest of all the coronary interventions performed in India. Today, the Apollo group of hospitals are leading the nation in undertaking highest number of Coronary Interventions in India; With 29 Cathlab facilities and 300+ Cardiovascular clinicians, Apollo Hospital is well-positioned to enhance their service offering across the country.” Dr. Sathyaki P Nambala, Senior Consultant, Cardio-Thoracic and Vascular Surgery said, “MCIS requires advanced training and besides Apollo Hospitals, there are only a handful of centers all over the world that are capable of performing MICS safely. Apollo Hospitals, Bengaluru sees surgeons visiting us from all over the globe for training in MICS. Going forward, we aim to train more surgeons to make this treatment option available for the patients everywhere. The aim is to augment our existing MICS program with Robotics technology to make Apollo Hospitals as an international destination for the advance cardiac care. Apollo Hospitals has been committed to treating the cardiac patients through innovative, modern state-of-the-art medical techniques with a renowned team of specialists. Today, it is an undoubted leader in three key innovations – MitraClip, TAVI (Trans-catheter Aortic Valve Implantation) or TAVR (Trans-catheter Aortic Valve Replacement) and MICS (Minimally Invasive Cardiac Surgery). MitraClip comes as a godsend to patients with Heart Failure due to Mitral regurgitation. Mitral regurgitation is a major component, worsening outcomes in heart failure patients and contributing to the extremely high mortality of 50% in 5 years. This revolutionary new device has been proven to drastically improve outcomes in these patients. The MitraClip has come as a blessing to heart failure patients and simply repairs the mitral valve by clipping its leaflets together. The procedure is performed in a Cardiac Cath Lab via a vein in the leg. The recovery is dramatic with the patients feeling better the very next day. The Apollo Hospitals Group is among a select few centers in India accredited to perform the MitraClip procedure for heart failure patients with a high success rate due to the skill and expertise of the doctors performing the treatment with stringent quality control. Led by Dr. Sai Satish, Senior Interventional Cardiologist, Apollo Hospitals is the leading center in India performing 6 of the 9 MitraClip procedures performed in India Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Aortic Valve Replacement (TAVR) allows a cardiologist to replace a malfunctioning valve in a patient’s heart in a minimally invasive procedure without cutting open the chest. It is performed for a common heart valve disease called aortic stenosis that leads to significant mortality and morbidity in the elderly population. Until recently, the diseased valve could only be replaced by open heart surgery which was difficult in old age. TAVI has emerged as a promising alternative for open heart surgery giving elderly patients a second chance at life. TAVI repairs the valve without removing the old, damaged valve. A fully collapsible replacement valve is taken to the valve site through a catheter.  Once the new valve is expanded, it pushes the old valve leaflets out of the way and the tissue in the replacement valve takes over the job of regulating blood flow. TAVR / TAVI team is led by Dr. Sengottuvelu G., Senior Consultant and Interventional Cardiologist. MICS (Minimally Invasive Cardiac Surgery) CABG is changing everything about coronary bypass. Gone are the days of prolonged hospitalization and even longer recovery. Even following a triple vessel bypass, hospital stay is a mere 2 days as unlike conventional heart surgery, recovery is rapid, with faster mobilization and rehabilitation.  80% of patients receive no blood transfusion. Post-surgery, patients are walking within 24 hours of operation. Pain management is simple. Those who have undergone MICS CABG seem mentally stronger and more confident during their recovery immediately after the procedure. MICS is the most advanced method of bypassing blocked blood vessels in your heart without splitting or cutting through the breastbone (sternotomy). The outcomes have been exceptionally good and better than the best hospitals in the world. The procedure ideal in diabetics and older patients who have poor resistance to infection and poor fitness for traditional surgery. Apollo Hospitals is one of the few centers across the world capable of performing MICS safely with a highly skilled team led by Dr. Sathyaki P Nambala, Senior Consultant, Cardio-Thoracic and Vascular Surgery. Additionally, Apollo Hospitals has also been at forefront in adopting AI (Artificial intelligence) in the area of disease diagnosis and prevention. The Apollo Hospitals partnership with Microsoft’s AI Network for AI-powered Cardiovascular Disease Risk Score API in India is a successful example in early diagnosis and prevention of cardiac disease. The death rate due to cardiovascular diseases (CVD) rose by around 34% in India between 1990 and 2016 and continues to rise as the leading cause of death. The World Health Organization has set the goal of reducing the risk of premature mortality (30 to 69 years of age) due to NCDs, including cardiac disorders, by 25% by 2025.  Structural and Interventional Cardiology is passing into a new era of medical science in India. Future advances in medical technology with a wider use of structural heart therapies including TAVR, LAAC (left atrial appendage closure) and TMV (transcatheter mitral valve) repair and replacement, including repair of surgically inserted valves through MICS will help achieve the reduction in death due to CVD. Apollo Hospitals’ team with extensive experience in Structural and Interventional Cardiology will work to deliver high rates of success at part with international standards. ]]> https://biospectrumindia.com/news/97/13664/taiwan-looking-for-association-in-indian-market.html https://biospectrumindia.com/news/97/13664/taiwan-looking-for-association-in-indian-market.html Fri, 17 May 2019 11:15:00 +0530 The second edition of Taiwan Expo 2019 in New Delhi organised by Bureau of Foreign Trade (MOEA) and Taiwan External Trade Development Council (TAITRA) witnessed potential healthcare companies from Taiwan looking for association in Indian market. The Expo witnessed Taiwan-India Medical Cooperation Forum providing Indian companies an opportunity to learn about Taiwan’s current healthcare development, its diverse strength in the field of medical equipment, economic, trade etc. and the areas in which the two countries can co-operate in the future. The "Taiwan Healthcare Pavilion" themed as "Medical Science and Technology" and focuses on Taiwan’s high-quality services, such as medical services, materials, biotech, and Smart Healthcare equipment. TSENG JU, Deputy Minister, Hsinchu Science Park Bureau spoke about Taiwan’s competitive Medical & ICT industry and how the expo aims to foster more cooperation and exchanges between Taiwan and India. Taiwan External Trade Development Council (TAITRA), is looking at starters, venture partnership and strategic partnership for long term and help foster growth between both the countries.  The world-famous high-tech industrial park, Hsinchu Science Park from Taiwan, lead 8 potential Taiwan companies to India for the Taiwan-India Medical Cooperation Forum. India is the base for Taiwanese companies to venture into profitable industries and consumer markets worldwide, and it is also the foothold for TAITRA to lead Taiwanese entrepreneurs to explore the global market. As a multi-faceted exhibition aimed at marketing Taiwan, Taiwan Expo is the perfect platform to introduce Taiwan to India, and strengthen the exchange for both sides. Speaking on the occasion, TSENG JU, Deputy Minister, Hsinchu Science Park Bureau, said, “Taiwan medical with its well-known high-tech precision equipment, professional medical team and services had been well recognized by the world. The key objective of Taiwan-India Medical Cooperation Forum is to help promote cooperation and exchange between both the countries and to assist manufacturers to expand in these markets. Looking at India from a Taiwanese perspective, I see a vibrant country that is full of possibilities. In recent years, bilateral trade between Taiwan and India has grown immensely and we want to strengthen this relationship more, especially in medical industry.” He further added by stating, “I would like to invite the Indian companies to explore the immense potential, infrastructure and technology Taiwan brings. This will help in creating new links with India and generate mutual progress and prosperity together. We aim to collaborate with like minded companies and build a solid relationship between both the countries.”  In 2018, Taiwan and India’s total bilateral trade volume reached US$7 billion, a 5-year high and an 11% increase from 2017. Bilateral trade investments are also on the rise. Such growth illustrates the successful combination of Taiwan’s New Southbound Policy and Act East Policy from India, the benefits of synergy, and the increasingly strong interaction between the two countries’ people and businesses. Leading healthcare companies of Taiwan Medicode Technology Co., Ltd, Surgery Pro & Implant Pro Combo System, Alexandave Ind. Co., Ltd, National Cheng Kung University Hospital, Changhua Christian Medical Foundation, Changhua Christian Hospital, Imedtac Co., Ltd, LITE-MED INC, Markstein Sichtech Medical Corp also attended the expo. ]]> https://biospectrumindia.com/news/97/13660/indias-state-forensic-labs-to-expand-its-infrastructure.html https://biospectrumindia.com/news/97/13660/indias-state-forensic-labs-to-expand-its-infrastructure.html Thu, 16 May 2019 17:15:00 +0530 Led by Delhi and Maharashtra, India’s forensic laboratories have managed to reduce pendency of DNA testing cases by a 50% national average. While Delhi has eliminated most of its case backlog, Maharashtra is upgrading facilities across regions like Aurangabad and Amravati as a response to the ever-increasing demand for DNA testing from law enforcement agencies and courts. In the north, Delhi was facing a pendency of 9,000 DNA testing samples in 2017 but with concrete steps to upgrade infrastructure and manpower, the state FSL has managed to eliminate most of its backlog in over a year. Similarly, in the western region, Maharashtra has been working on reducing a backlog that stood at 1,700 DNA cases in 2017 – a majority of which are related to sexual offences against women & children. The state receives 4,500 cases of DNA analysis in a year with demand increasing by nearly 20% annually and is expected to extend DNA testing facilities from presently five to all its eight forensic labs this year. Dr Rajiv Giroti, Dy. Director CFSL, Hyderabad said, “There’s been a huge impetus witnessed in forensic infrastructure across India’s FSLs over the last one year, with rising demand for DNA testing in criminal investigation. This has led to substantial reduction in backlog of cases to nearly 50%. Delhi and Maharashtra have performed exceptionally well! They are seen to steadily and speedily work on expansion of district level facilities, stepping up workforce with more experts and technical staff with high-throughput equipment to expedite investigations and provide breakthroughs”. As per recent reports, DNA testing infrastructure is being upgraded across all state forensic science laboratories. Larger states like Maharashtra and Tamil Nadu are expanding facilities across districts to increase coverage and reduce the load on existing labs. In the south, Tamil Nadu is seen to expand a good number of regional level labs. Up north, Himachal Pradesh, has stepped up infrastructure with their two range forensic labs, and in the east, Guwahati too is expected to set up its FSL within next 6 months. The central forensic science laboratories (CFSL) capability in India is also on an expansion mode. Pune is soon to rebuild and upgrade its CFSL in next 8-10 months. This would be in addition to its existing FSL facility in the region. Tim Schellberg, Founder & President, Gordon Thomas Honeywell—GA notes, “It is good to see that India is building its forensic infrastructure to tackle the increasing demand for DNA testing. However, we must remember that 20,000 DNA profiles is not near enough in a country of a billion people with half a million reported violent crimes every year. There is an immediate need to scaling that up by 10 times. I hope India continues the momentum in adopting the world’s best crime fighting technology to build safer communities. Dr Rajiv Giroti, Dy. Director CFSL, Hyderabad added, “With close to 28 state forensic labs having DNA testing facilities in the country today, we still have a long way to go in terms of making this technology accessible with a better lab-to-population ratio. India has a rich talent pool available in this field with reputed academic institutes in forensic biology, fully equipped to train them. By creating the right job opportunities therefore, we will be able to bridge the supply-demand gap”. Shortage of well-equipped, hi-tech laboratories and inadequate staff strength at forensic labs has long been responsible for the delay in forensic examination of suspects leading to rise in the backlog of court cases. According to Directorate of Forensic Science Services (DFSS), more than 12,000 DNA samples from sexual assault cases were awaiting examination in three of the six CFSLs across India till December 2017. Last year however, saw a reversal of trend on back of a series of initiatives being announced to enhance the country’s forensic infrastructure. The biggest step was taken by the Union Ministry of Women & Child Welfare to upgrade the Chandigarh CFSL with state-of-the-art 'Sakhi Suraksha' lab to expedite investigation and prosecution of violent crimes against women. As per recent estimates, the number of DNA profiles developed from crime scene evidence has doubled over a year from 10,000 cases tested in 2017 to nearly 20,000 this year1. This increase in DNA casework can be attributed to an upward trend in reporting of rape & sexual violence cases owing to public awareness and activism along with steps taken by the government to upgrade police and forensic infrastructure. Forensic DNA has emerged as the most reliable crime fighting technology the world over. Many countries are effectively using forensic labs and protocols to collect, test and compare DNA at crime scenes with that of suspects with promising results. Where law machinery world over is increasingly relying on DNA forensics to solve crime, the pace in India has been slow. Lack of scientific methods in investigations and absence of a proper policy framework in the country continue to hamper justice. ]]> https://biospectrumindia.com/news/97/13641/roche-launches-detection-test-for-antibiotic-resistance-in-tb.html https://biospectrumindia.com/news/97/13641/roche-launches-detection-test-for-antibiotic-resistance-in-tb.html Wed, 15 May 2019 14:50:00 +0530 Roche has announced the CE-IVD launch of the cobas® MTB-RIF/INH test to detect resistance to antibiotics within tuberculosis DNA. This assay is part of the mycobacteria test menu that includes the cobas® MTB and cobas® MAI tests for use on the cobas® 6800/8800 Systems. This continues the expansion of the testing menu on the cobas 6800/8800 Systems, supporting true consolidation and efficient testing. Tuberculosis is the leading cause of infectious disease deaths worldwide.1,2 The rising challenge of drug resistance compounds the tuberculosis global health crisis. The high sensitivity of the cobas MTB test enables increased detection of tuberculosis in challenging smear-negative samples. A complete mycobacteria test menu provides the flexibility to detect a combination of tuberculosis, drug resistant tuberculosis and nontuberculous mycobacteria infections from a single patient sample. This provides important information for patient care decisions. “With the addition of cobas MTB-RIF/INH to the mycobacteria test menu, we are able to equip laboratories with flexible, sensitive solutions to best help them diagnose tuberculosis, which is difficult to detect,” said Michael Heuer, CEO Roche Diagnostics. “This menu approach not only aids healthcare providers in addressing the global health challenge that tuberculosis presents, but also provides clinicians the valuable information they need to properly diagnose these respiratory infections to speed treatment and reduce the spread of infection.” The fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands. ]]> https://biospectrumindia.com/news/97/13630/iqvia-launches-dedicated-solutions-for-medtech-diagnostic-industry.html https://biospectrumindia.com/news/97/13630/iqvia-launches-dedicated-solutions-for-medtech-diagnostic-industry.html Tue, 14 May 2019 14:25:00 +0530 IQVIA has announced the launch of IQVIA MedTech and its dedicated industry focused solutions and services for the medical device and in vitro diagnostics market, and for companies with combination products. IQVIA MedTech empowers companies to orchestrate operations across their entire product lifecycle, from conceptto-market, providing quality control, regulatory, safety and compliance solutions along the way. “We have served more than 800 MedTech clients in more than 70 countries by delivering an extensive suite of products, services and domain expertise for this space and for our customers’ needs,” said Bhavik Patel, senior vice president, IQVIA MedTech. “From helping our clients develop and execute clinical trials to entering new markets to managing regulatory processes, IQVIA MedTech supports a company’s individual needs worldwide.” With access to cutting-edge technology and deep domain expertise, IQVIA MedTech breaks down silos across the product lifecycle and provides information at a geographic scale to drive expansion into global markets. Using innovative technology and tailored-consulting services, dedicated IQVIA MedTech account teams help companies address global implications of client compliance programs and develop strategies to keep pace within constantly evolving environments. IQVIA MedTech’s comprehensive suite of Clinical to Commercial solutions including Integrated Global Compliance involving Regulatory Intelligence (RID), Regulatory Information Management (RIM) and Enterprise Quality Management (QMS) and Commercial Compliance provide for comprehensive regulatory and compliance needs. Additionally, MedTech products, managed services, and consulting offerings can help companies automate and address vigilance and safety processes. IQVIA MedTech offers a unique single-source alternative to disparate providers, yet integrates well with existing systems and processes. ]]> https://biospectrumindia.com/news/97/13616/alivecor-gets-fda-nod-for-its-six-lead-personal-ecg-device.html https://biospectrumindia.com/news/97/13616/alivecor-gets-fda-nod-for-its-six-lead-personal-ecg-device.html Mon, 13 May 2019 15:35:00 +0530 AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), announced its third FDA clearance in three months, making KardiaMobile 6L the world's first available six-lead personal ECG device. This highly anticipated clearance gives patients and their physicians an even more detailed view into patients' hearts, including visibility into certain arrhythmias that are leading indicators of cardiovascular disease. "KardiaMobile 6L is the most clinically valuable personal ECG ever created, and another significant step in AliveCor's march to making heart care more convenient, more accessible, and less expensive than ever before" said AliveCor CEO Ira Bahr. The KardiaMobile six-lead device is consistent in design with AliveCor's existing KardiaMobile.  But, in addition to the two electrodes on the top of the device, there is one additional electrode on the bottom. The user places her thumbs on each of the two top electrodes, and places the bottom electrode on her left knee or ankle. This formation, known in cardiology as the Einthoven Triangle, allows cardiologists to view electrical activity in the heart from six perspectives or "leads." A six-lead ECG provides physicians with a far superior view of the heart than a single lead ECG, giving them ability to detect a far broader range of arrhythmias and other heart conditions, all without the hassle of gels or wires. ]]> https://biospectrumindia.com/news/97/13555/abbott-launches-heart-monitor-for-better-arrhythmia-detection-.html https://biospectrumindia.com/news/97/13555/abbott-launches-heart-monitor-for-better-arrhythmia-detection-.html Tue, 07 May 2019 11:25:00 +0530 Abbott has announced the launch of a new, smarter heart monitor for better arrhythmia detection—positive news for people at risk for irregular heartbeats. Now with CE Mark in Europe and U.S. Food and Drug Administration (FDA) clearance, the next-generation Confirm Rx™ insertable cardiac monitor (ICM), a paperclip-sized implantable device, combines smartphone connectivity and continuous, remote monitoring to track unpredictable heart rhythm problems for fast and accurate diagnosis. An arrhythmia is an abnormal heart rhythm that can lead to symptoms such as the feeling that the heart is racing, dizziness, shortness of breath or fainting. Living with an irregular heartbeat can lead to constant questions for people battling symptoms. For the 33.5 million people living with atrial fibrillation (AFib)—the most common arrhythmia—many do not even know they have the condition. Abbott's Confirm Rx ICM is helping advance how physicians remotely monitor arrhythmias in people most at risk. Inserted just under the skin in the chest above the heart during a quick, minimally invasive outpatient procedure, the Confirm Rx ICM device is the only ICM on the market that syncs to a smartphone via Bluetooth® and transmits information to the physician to help identify irregular heartbeats quickly. Abbott's mobile app eliminates the need for an additional transmitter and is user-friendly health technology translated in nearly 40 languages. Avi Fischer, M.D., medical director of Abbott's Cardiac Rhythm Management therapies said, "Through new advances like Abbott's next generation of Confirm Rx ICM, physicians can act more proactively and efficiently in their treatment approach, and patients can stay engaged and connected.” Wearables used to track cardiac arrhythmias have limitations when it comes to making a clinical diagnosis. Many require recharging at night, which can lead to missing irregular heartbeats that may occur sporadically and infrequently. Others require some level of interaction by the person to record symptoms, which may not be top of mind when feeling light headed, dizzy or experiencing a rapid heart rate. Sean Beinart, M.D., a cardiologist with Adventist Healthcare in Rockville, Md said, "The rise in health monitoring has undoubtedly increased awareness of arrhythmias such as AFib, but many of these devices still aren't leading to an improved diagnosis or solving the key clinical challenges for people at risk. Like a guardian for heart health, Confirm Rx ICM can relay important data about a person's heart rhythm through their smartphone and alert their care team to a potentially dangerous heart event. With Abbott's new technology, I can better identify risk—making it actionable for me and life-changing for my patient." Unlike other monitoring technology that can lead to gaps in arrhythmia detection, Confirm Rx ICM provides continuous 24/7 monitoring. The new detection technology in Confirm Rx ICM reduces false detection by 97 percent and avoids alerting physicians of irregular heartbeats that may not actually signal a cardiac arrhythmia. The next-generation version of Abbott's Confirm Rx ICM incorporates new SharpSense™ technology, which was designed with physician feedback and insights from the people who have benefited from the Confirm Rx ICM since it was first commercialized in 2017.   ]]> https://biospectrumindia.com/news/97/13547/who-prequalifies-abbotts-breakthrough-hiv-test.html https://biospectrumindia.com/news/97/13547/who-prequalifies-abbotts-breakthrough-hiv-test.html Mon, 06 May 2019 15:45:00 +0530 Abbott has announced that m-PIMA™ HIV-1/2 VL, the world's first point-of-care viral load diagnostic test, has received the World Health Organization's Prequalification approval (WHO PQ). The test received CE Mark in December 2018. "m-PIMA HIV-1/2 VL is the only truly portable molecular point-of-care test designed specifically for use in resource-limited settings such as in sub-Saharan Africa," said Damian Halloran, vice president, Infectious Disease – Emerging Markets, Rapid Diagnostics, Abbott. "With WHO PQ, global funders and ministries of health can now confidently expand access to viral load testing, reaching more people who need the test, with the most compact and efficient point-of-care HIV diagnostic platform available anywhere in the world today." To provide the most effective HIV treatment and care, the WHO recommends that everyone receiving antiretroviral therapy (ART) undergoes a viral load test at 6 months and 12 months, and annually thereafter, if the individual is stable on ART. Viral load testing is the gold standard for monitoring ART treatment failure. Unfortunately, very few people in resource-limited settings, such as select countries in sub-Saharan Africa, Asia and Latin America, have access to the necessary level of care. Abbott's m-PIMA HIV-1/2 VL is a quantitative nucleic acid amplification test for viral load measurement of HIV type 1 groups M/N and O, and HIV-2 in plasma samples. The platform is portable so it can be brought into the most remote locations. It's easy to use, deployable at the point of care and designed to measure viral load in under 70 minutes, while the patient is still present. This allows people to receive results during the same visit and enables immediate treatment decisions, thereby reducing the number of people lost to follow-up. The test's quick turnaround time is particularly valuable for monitoring the viral load of HIV-positive pregnant women and in cases of suspected HIV treatment failure. The m-PIMA HIV-1/2 VL is part of Abbott's comprehensive portfolio of diagnostic solutions for HIV screening, monitoring and viral load management. From the core lab to the point of care, Abbott provides critical tools to help healthcare providers make informed treatment decisions for people living with HIV. ]]> https://biospectrumindia.com/news/97/13517/siro-clinpharm-undergoes-a-brand-refresh.html https://biospectrumindia.com/news/97/13517/siro-clinpharm-undergoes-a-brand-refresh.html Thu, 02 May 2019 13:10:00 +0530 Siro Clinpharm has announced a refresh of its core brand elements. Reflecting the growth and evolution of Siro as India’s leading CRO (Clinical research organisation), the brand elevates the focus on dependability, progressiveness, being scientific, and best in industry. This brand refresh syncs with the next phase of Siro’s evolution. In this phase, Siro will focus on doubling the India team to 500 resources in three years, establish a strong operational presence in the US and invest heavily in technology and automation. The new bold and vibrant logo in purple and lime green embodies the characteristics of the company’s committed team of employees. The colour is mainly used to convey credibility and evoke associations of quality, strength and steady determination. The logo employs an eye which symbolises an eye for detail, and an eye for humanity, resulting in the endeavour to achieve the highest standards in quality. Akshay Daftary, Director, Siro Clinpharm said “We are excited for the brand refresh the company has undergone. Our refreshed logo and streamlined brand architecture convey the continuing evolution and growth of our business, and proudly display the characteristics we want to communicate to our stakeholders about our brands. ]]> https://biospectrumindia.com/news/97/13512/callhealth-livehealth-to-accelerate-healthcare-diagnostics-in-india.html https://biospectrumindia.com/news/97/13512/callhealth-livehealth-to-accelerate-healthcare-diagnostics-in-india.html Thu, 02 May 2019 10:30:00 +0530 CallHealth, the world’s first and truly integrated healthcare platform for “Everything about health”, has announced its tie-up with LiveHealth, a SaaS based end-to-end collaborative report management solutions enterprise that automates the entire lifecycle of customer’s diagnostic assessment journey- from sample on-boarding, lab instrument interfacing to intuitive report delivery. CallHealth, in its journey towards reaching 1 Billion+ Smartphone users and over 400 million households in India plans to integrate with over 5,500 Diagnostic Labs and Imaging Centres by FY 2020. The partnership with LiveHealth platform will help to:  A. Significantly reduce the report delivery time, even in rural markets, from Diagnostic and Imaging Lab Partners, enabling CallHealth’s expansion in 1000+ cities and towns in India. Currently, LiveHealth has 2200+ installations in India in different cities. In the initial phase of growth, CallHealth will prioritize the onboarding of lab partners with LiveHealth in new markets that it chooses to operate.  B. Leverage CallHealth’s Artificial Intelligence and Machine Learning capability to drive insights and share actionable Smart Reports to its customers. The Actionable Insights to consumers and clinicians will be derived by leveraging CallHealth’s clinical protocol capabilities and LiveHealth's AI driven insights from the proprietary data dictionary. C. Achieve Scale at a faster pace. With natural synergies in place, CallHealth and LiveHealth can expand their presence in new markets and offer enhanced service models such as Platform as a Service (PaaS). CallHealth and LiveHealth will explore a joint solutioning model wherein CallHealth and LiveHealth will provide a comprehensive cloud-based Laboratory Information Management System for customers, clinicians and qualified medical professionals. Commenting on the benefits of the partnership for the health ecosystem as a whole and customers in particular, Mr. Hari Thalapalli, CEO, CallHealth said, “The tie-up with LiveHealth will not only help create deep integration within the provider ecosystem, it will also change the speed and manner in which customers can access, interpret and use their diagnostic report results. This partnership will thus enable faster sample collection, instrument interfacing and barcoding, comprehensively manage the customer’s health information and ensure reports provide real-time intuitive health insights that are instantly accessible to the customer.” Stating the importance of this association, Mr. Abhimanyu Bhosle, CEO & Co-Founder, LiveHealth said, “LiveHealth thrives to deliver the best connected, simpler & safer experience through our products. And to do this, we work with healthcare providers in the most consolidated manner, to know more about how records are generated, where technology can deliver its best, and how patient experience can be improved. Tie-up with CallHealth, India’s leading enterprise in the space it operates in, will ensure LiveHealth puts its protocols for use of a wider range of customers.” ]]> https://biospectrumindia.com/news/97/13510/exclusive-vertical-in-cdsco-will-check-garage-manufacturing-mtai.html https://biospectrumindia.com/news/97/13510/exclusive-vertical-in-cdsco-will-check-garage-manufacturing-mtai.html Thu, 02 May 2019 09:00:00 +0530 Medical Technology Association of India (MTaI) has released a statement saying that creation of a separate vertical in Central Drugs Standard Control Organisation (CDSCO) exclusively to govern medical devices will check ‘garage manufacturing’. Kaustav Banerjee, Director, MTaI said, “Capacity building is always a good initiative and has been long overdue. Regulators should build capacity and capability to prevent inferior products from entering the market which was happening through a large number of unregistered garage manufacturing in India, particularly in orthopedic industry. Global innovators are not just operating in India but in several developed countries across the globe and they follow global regulation and are accountable; these globally accepted standards of quality are also complied by several domestic manufacturers, which make exports from India acceptable in global markets. A separate vertical in CDSCO, as proposed by DTAB, will curb the menace of unregulated garage manufacturing.” Pavan Choudary, MTaI Chairman and Director General said, “The proposal of DTAB to have a separate vertical in terms of manpower and infrastructure in CDSCO for medical devices is welcome. It is reflective of the understanding that new categories of skill-set are required to regulate this sector. The fact that this vertical will be under the CDSCO, sensitively uses the umbrella of the body which has the maximum expertise and experience in governing the medical device universe. As new devices are coming under regulation in line with government’s objective of ensuring patient safety, it will be great if the recruitment begins soon so that this additional workload is efficiently handled.” The Drugs Technical Advisory Board (DTAB) has proposed creation of a vertical in CDSCO specifically for medical devices to enable the latter regulate all medical devices sold in the country in phases. As per the proposal, CDSCO will hire 754 officers for the vertical. ]]> https://biospectrumindia.com/news/97/13488/isic-to-set-up-a-world-class-med-tech-laboratory-in-india.html https://biospectrumindia.com/news/97/13488/isic-to-set-up-a-world-class-med-tech-laboratory-in-india.html Mon, 29 Apr 2019 10:30:00 +0530 The Indian Spinal Injuries Centre (ISIC) in collaboration with the Indian Institute of Technology (IIT), Delhi, the Hamburg University of Technology (TUHH) and the University of Toledo recently organized a three day conference on Clinical Orthopedics & Spine Biomechanics in New Delhi. In a bid to augment the development of world-class medical technology in India and ensure indigenous implants meet the global standards, ISIC will set up a world-class laboratory to test their quality. Dr. H S Chhabra, Medical Director of Indian Spinal Injuries Centre, New Delhi at the said, “Implants developed in India often do not match up to the international standards. There is no comprehensive implant testing laboratory in India now. The implants developed in India do not go through the rigorous quality checks and we are largely dependent on imports for quality implants most of which are designed for Caucasian population and may not suit the Indian body types. We will collaborate with premier institutions such as IITs to develop this laboratory and ensure products complying with international standard. I thank the faculty members and engineers from India and abroad to help us set up this first-of-its kind laboratory in India.” Medical fraternity converged at the inauguration of the three-day event emphasized on the importance of artificial intelligence (AI) and technological advancement for customized products and better services, and hoped that the increasing importance of healthcare in election campaigns and overall political discourse will provide the necessary impetus. Dr. A K Mukherjee, Director General of Indian Spinal Injuries Centre said, “The sustainable development goals (SDGs) have a social aspect and healthcare is at the heart of social development. If we look around the world, health has become an important issue in the election – elections in the US, the UK, Turkey, Japan and India have seen focus on healthcare programs. This creates a great momentum for the development of the healthcare services and bringing more people with disability to the mainstream.” “Artificial intelligence has become the new electricity. Our healthcare development is centered around technical development. Along with AI, technological development will play a very critical role in evolving evidence-based understanding. We got a National Healthcare Policy after 14 years and the NITI Aayog is developing a program on healthcare that is AI-based to a great extent. Biotech is another area that holds a lot of promise but developing its experimental side will need a lot of investment – by 2030, an estimated $ 6 trillion will be used for healthcare programs, mainly due to the rapid spread of non-communicable diseases,” adds Dr. Mukherjee. Dr. H P S Ahluwalia, Chairman of Indian Spinal Injuries Centre said, “A lot has changed in past 40 - 50 years in India – I have never heard of AI in healthcare. I am very happy to see so many youngsters here today and would like them to contribute to this pioneering research.” Hailing the efforts if ISIC in setting up a biomechanics laboratory at the premises, Dr. Patrick Kluger, an eminent spine surgeon from Germany says, “Biomechanics laboratories and clinics remain disconnected, mostly. It is important that both biomechanics and clinics are available in one place for a better implementation of the new developments.” Workshops as parallel sessions with demonstrations on various orthopedic and spinal problems was also the part of the conference. ]]> https://biospectrumindia.com/news/97/13444/axio-biosolutions-attains-world-class-position.html https://biospectrumindia.com/news/97/13444/axio-biosolutions-attains-world-class-position.html Wed, 24 Apr 2019 11:30:00 +0530 India’s leading innovative medtech company, Axio Biosolutions, recently expanded its state-of-the-art manufacturing facility at Gujarat Pharma Techno Park in Ahmedabad, India to over a million units annually and has become the largest chitosan medical sponge manufacturer globally. As the first-ever Indian company to design and launch a novel haemostat for moderate to severe bleeding, Axio Biosolutions has been consistently disrupting the wound care management industry. Its manufacturing facility is ISO 13485 certified and GMP approved, with an ISO 7, Class 10000 cleanroom. Now, with the cutting-edge factory that is 75 per cent automated, boosting the annual capacity to over a million units, the company is all set to conquer new frontiers. Commenting on the latest development, Gourav Maheshwari, Director – Finance & Operations, said, “Our products are proudly made in India for the global market. With this expansion along with USFDA clearance for our products we are closer to realising our aspirations to become a global medtech company from India. We have created more than 100 jobs for local community with a significant contribution of women staff, we believe this facility will set a benchmark for medtech manufacturing in India.“ Axio Biosolutions is a medtech company with focus on biomaterials. The company offers a complete range of innovative products spanning pre-hospital, intra-operative and post-operative clinical needs. Its first product range Axiostat is a USFDA and CE approved product that stops bleeding instantly. Earlier this year, the company launched MaxioCel, a next-generation, chitosan-based advanced wound care dressing that provides comfort and faster healing to patients suffering from chronic wounds. Axio Biosolutions recently announced its top-notch Scientific Advisory Board, comprising Dr Shiladitya Sengupta, Assistant Professor of Medicine at Harvard Medical School, as Chairman and Dr S V Mahadevan, Professor of Emergency Medicine at Stanford University, as member. Last year, the company raised $7.4 million in a Series B funding round led by Ratan Tata’s UC- RNT, along with existing investors Accel Partners and IDG Ventures India. Headquartered in Cambridge, Axio Biosolutions has its corporate office in Bengaluru. The company has strong R&D with multiple patents to its credit.   ]]> https://biospectrumindia.com/news/97/13445/lowering-diabetes-and-heart-risks-for-people-with-kidney-diseases-credence-trial-results.html https://biospectrumindia.com/news/97/13445/lowering-diabetes-and-heart-risks-for-people-with-kidney-diseases-credence-trial-results.html Wed, 24 Apr 2019 11:30:00 +0530 According to the CREDENCE trial which was recently published in the New England Journal of Medicine, a new treatment for people with diabetes and kidney disease reduced kidney failure rates by a third. The CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial is assess the effects of the SGLT2 inhibitor canagliflozin on renal outcomes in patients with type 2 diabetes and albuminuric chronic kidney disease, presented at the International Society of Nephrology (ISN), showed positive impact of the drug canagliflozin on lowering diabetes and cardio-vascular risk for people with kidney disease. The results also showed heart failure was reduced by over 30%, and major cardiovascular events by about 20%. The drug canagliflozin was developed to lower glucose levels for people with diabetes but today has been shown to protect against kidney failure. It also significantly reduced the risk of cardiovascular complications including heart failure, which are common among people with kidney disease. Around 70 million people in India have diabetes and up to 40% will go onto develop kidney disease.   Lead author Professor Vlado Perkovic, of The George Institute for Global Health, said there was an urgent need for this new treatment given the surging rates of diabetes. “Diabetes is the leading cause of kidney failure worldwide but for almost two decades there have been no new treatments to protect kidney function. This definitive trial result is a major medical breakthrough as people with diabetes and kidney disease are at extremely high risk of kidney failure, heart attack, stroke and death. We now have a very effective way to reduce this risk using a once daily pill.” Researchers say the results, which were presented at the ISN World Congress of Nephrology in Melbourne, can be implemented immediately as the drug is already available. The study recruited 4,401 patients with diabetes and kidney disease from 34 countries. Half were given canagliflozin on top of best available current care for kidney disease – using either angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). The control group received best available care according to current guidelines, and a placebo. Key Findings The number of people developing kidney failure or dying from either renal failure or cardiovascular disease was reduced by 30%. Hospitalisation for heart failure was reduced by 39%. The risk of major cardiovascular outcomes - (heart attack, stroke and cardiovascular death) was reduced by 20% There was no increased risk of major side effects. Professor Vivekanand Jha, Executive Director of The George Institute India and President of the International Society of Nephrology, said: “What the trial has shown is that this drug not only protects people with diabetes from developing kidney failure, but it also protects them from heart disease, heart failure and other cardiovascular complications. Importantly, it helps people who already have reduced kidney function and are at particularly high risk. With five million people predicted to have kidney failure by 2035 this is a major breakthrough.” The researchers found the drug canagliflozin, a sodium glucose transporter 2 (SGLT2) inhibitor, was less effective at lowering blood sugar in people with reduced kidney function but still led to less kidney failure, heart failure and cardiovascular events such as heart attacks, strokes and death from cardiovascular disease. Professor Perkovic said the results were impressive. “The substantial benefit on kidney failure despite limited effects on blood glucose suggest that these drugs work in a number of different ways beyond their effects on blood sugar. This is an area of intense ongoing research.” The randomised study was funded by Janssen, which manufactures canagliflozin, and led by an independent, academic- led Steering Committee. ]]> https://biospectrumindia.com/news/97/13420/bd-celebrates-70-years-of-advancing-specimen-collection-.html https://biospectrumindia.com/news/97/13420/bd-celebrates-70-years-of-advancing-specimen-collection-.html Mon, 22 Apr 2019 15:00:00 +0530 Dialogue 2019 Leadership Summit organized by BD Life Sciences – Preanalytical Systems in India marked the success of 70 years of BD Vacutainer® worldwide. Considered as the gold standard in sample collection, the summit was attended by leading names from the industry: Dr. A Velumani, founder and CMD, Thyrocare, Om Manchanda, CEO, Dr LalPath Labs, Dr. Nandakumar Jairam, CEO, Columbia Asia Hospitals, Dr. Vandana Jain, Head, Head - Accreditation of Medical Testing Laboratories, Dr Navin Dang, Founder, Dr. Dang Labs, Sanjeev Vashishta, CEO, Pathkind, Dr. Shubnum Singh, Diretor, Max Group of Hospitals & Healthcare Sector Skill Council Chairperson, Dr. Sanjay Arora, Managing Director, Suburban Diagnostics and Girish Mehta, CEO, Eurofins. The discussions held at the event brought forth impactful insights garnered from like-minded, visionaries with a focus on quality and patient outcomes for advancing the world of health. A fragmented diagnostic sector in India demands accurate and reliable pathology laboratory results to enable doctors in providing evidence-based patient care and quality treatment. In this pursuit of excellence and quality, all the attendees expressed a well-rounded perspective of offering their best in serving the patients. They also acknowledged that the complicated industry requires strong cohesion between public and private partners to advance the world of health, together. Speaking about the legacy of BD Vacutainer® Pavan Mocherla, Managing Director, BD–India & South Asia, said “With our work in market development, innovation and commitment towards advancing healthcare and improving patient outcomes, we aim to maintain the gold standard created by BD Vacutainer®. What might appear to be a simple plastic/glass tube, is an epitome of dedicated science, with years of expertise and experience packed into it. However, our work does not end there. Training of healthcare workers to manage sample collection optimally is invaluable for accurate diagnosis and treatment outcomes; hence, BD has been committed to capability building. Looking back at the 70 years of innovation and the road ahead excites me about the opportunity we have to shape the ever-evolving diagnostics industry in India.” Seventy years ago, BD Vacutainer® products helped transform the collection process, making it safer and more comfortable for patients and clinicians. Today, every second, 82 patients have specimens collected with BD Vacutainer® products and continues to increase sample integrity and set a whole new standard in diagnostic accuracy. Every day, people entrust their health to their doctors’ treatment decisions—decisions that are informed by a diagnostic result 70 percent of the time. But reliable results would not be possible without proper, safe specimen collection and management by healthcare professionals and the products they choose. The real challenge with specimen happens in the complex critical care settings (ICU & Emergency). BD continues to work with clinicians to increase reliability, accuracy, and integrity with their new specimen management solutions.   Legacy of 70 years:   Joseph Kleiner changed the course of specimen collection by inventing and patenting (1949) a revolutionary way to collect blood - the new “Evacutainer”—which would come to be known as the BD Vacutainer® blood collection tube BD launched the complimentary range of multi sample straight needles (1968), BD Vacutainer® urine collection tubes (1971) and BD Microtainer® blood collection tubes for capillary collection (1977) At the height of the HIV epidemic, BD continued to advance safety by launching the BD Hemogard™ safety-engineered cap (1988) and the BD Vacutainer® Eclipse™ safety needle (1999) to prevent human contact with blood and Needle stick injuries. BD is now focusing on improving outcomes through the launch of the first mechanical separator technology in BD Vacutainer® Barricor™ plasma blood collection tubes (2016) & the PAXgene® Blood ccfDNA Tube CE IVD (2016) for Prenatal and liquid biopsy testing.   ]]> https://biospectrumindia.com/news/97/13383/thermo-fisher-nx-prenatal-to-develop-pregnancy-outcome-assay.html https://biospectrumindia.com/news/97/13383/thermo-fisher-nx-prenatal-to-develop-pregnancy-outcome-assay.html Sun, 21 Apr 2019 09:00:00 +0530 Thermo Fisher Scientific, the world leader in serving science, and NX Prenatal Inc., a recognized leader in the detection, monitoring and management of pregnancy-related complications using novel exosome-based methods, have entered into a collaboration to develop clinical mass spectrometry-based proteomics assays to monitor fetal health in utero and assess the risk of adverse outcomes, including preterm birth and preeclampsia.  This new collaboration recognizes the challenges faced by medical professionals who have few tools available for noninvasive risk stratification for adverse pregnancy outcomes. By combining NX Prenatal’s NeXosome platform with Thermo Fisher’s leading liquid chromatography-mass spectrometry (LC-MS) instrumentation, the workflows can address the reliability, accuracy and precision of the analytical solutions currently available to clinical scientists. The unique NeXosome technology is used to enrich maternal blood samples for microparticles, such as exosomes, which play key roles in maintaining certain balances between the mother and fetus during pregnancy. Aberrations in these balances have been shown to correlate with the likelihood of adverse pregnancy outcomes. Merging the NeXosome platform with Thermo Fisher LC-MS technology has the potential to generate fast, efficient and accurate data for the analysis of exosome-derived proteomic biomarkers, which may lead to increased information about maternal and fetal health during pregnancy. Ultimately, the analysis has the potential to support obstetrical care decisions in conjunction with traditional clinical assessments.  ]]> https://biospectrumindia.com/news/97/13370/exhaustive-analysis-needed-before-notifying-more-medical-devices-mtai.html https://biospectrumindia.com/news/97/13370/exhaustive-analysis-needed-before-notifying-more-medical-devices-mtai.html Tue, 16 Apr 2019 09:00:00 +0530 Medical Technology Association of India (MTaI) has announced that while the overall decision of the DTAB to bring more devices under regulation is a welcome step its implementation needs exhaustive consideration. Pavan Choudary, Chairman, MTaI said, “First, an exhaustive analysis of the un-notified part of the device universe is required. Some of these products could be critical & life-saving, but sold in tiny quantities. CDSCO could look at revising downwards the registration fees so that the market stays attractive to these small but vital operators. Also, a game plan should be ready to make up for their likely departure for reasons of viability. To handle the additional workload, CDSCO should assess whether the manpower mandated by DTAB is available to regulate the new devices expeditiously.” “Medical devices are generically different from drugs and therefore cannot be treated as drugs in the long run. The government should expedite the deliberations on institutionalizing a suitable and exclusive legal framework for medical devices so that areas of quality, adverse events, compensation, prices, healthcare training, Health Technology Assessment, et. al. are comprehensively addressed”, he added. The association said the decision to bring more devices under regulation is welcome as it would strengthen patient safety, but the government should also prioritize creation of separate law for medical devices.     ]]> https://biospectrumindia.com/news/97/13332/lifecell-introduces-genetic-testing-for-cord-blood-samples.html https://biospectrumindia.com/news/97/13332/lifecell-introduces-genetic-testing-for-cord-blood-samples.html Thu, 11 Apr 2019 09:00:00 +0530 LifeCell International, India's first and largest community stem cell bank, has announced its next milestone - initiation of genetic testing on all cord blood samples before they are released for use. This will make LifeCell the world's first cord blood bank to add a significant layer of safety to ensure that cord blood stem cells released for transplants do not carry genetic abnormalities and are safe (conditions apply) for use in patients. Human Umbilical Cord blood is one of the preferred sources of stem cells. Its advantages are ease of collection at birth, rapid availability in case of need (not dependent on donor variables), can be preserved for decades, and can be combined with other sources of hematopoietic stem cells to hasten engraftment and improve overall benefit.  As India's largest stem cell community stem cell bank, LifeCell currently has an inventory of more than 32,000 units, which is growing by double digits each year. Access to such an inventory provides the community of families (those who have preserved their babies stem cells with LifeCell) more than 96% probability of finding matching stem cells for their loved ones - in case the need of hematopoietic transplantation arises. LifeCell has introduced these genomic profiling tests using cutting-edge next-generation sequencing (NGS) techniques. These newly introduced genomic tests will screen for approximately 7,000 inherited diseases and markers of childhood cancers. By screening specifically for genes known to be responsible for inherited diseases and cancer panels screening for childhood cancers, the results will be specific and robust in protecting patient safety. Dr Purvish Parikh, Professor of Medical Oncology and Group Oncology Director, Shalby Cancer and Research Institute, Shalby Group of Hospitals says, "Introduction of these tests would provide doctors and families of patients additional assurance regarding the quality of the cryopreserved cord blood stem cell that can be utilized for hematopoietic transplant. If the cord blood unit to be used is free from the risk of carrying cancers or inherited diseases, it is a big advantage." Ishaan Khanna, CEO, BioBank & Diagnostics Divisions, LifeCell International said, "LifeCell has always been leading the industry with new initiatives and this is one another in the interest of patient safety. These additional tests being introduced by LifeCell as part of its release criteria are entirely voluntary as they're not yet mandated by regulatory agencies. However, they are in line with the advancements in the field of genomics and are anticipated to soon become a part of the standard recommendations". LifeCell, established in 2004, is India's leading provider of preventive healthcare services for mother and baby wellness and healthcare solutions such as stem cell banking and diagnostic services. With facilities at Chennai and Gurugram and a network spanning over 200 cities in India and abroad, over 3,75,000 parents have trusted LifeCell for its services. LifeCell's umbilical cord blood stem cell banking, a community-based approach towards stem cell access, is a global first initiative that aims to provide families in India better future access to stem cells than even currently possible in advanced countries such as the US. As a comprehensive provider of preventive and diagnostic healthcare services, LifeCell presents a complete panel of pre and post-natal diagnostic tests including maternal infectious diseases test, prenatal screening and newborn screening. Through these services, LifeCell aims to provide complete wellness for the mother and baby ensuring healthy pregnancy and healthy newborns. ]]> https://biospectrumindia.com/news/97/13292/myriad-astrazeneca-and-merck-expand-companion-diagnostic-partnership.html https://biospectrumindia.com/news/97/13292/myriad-astrazeneca-and-merck-expand-companion-diagnostic-partnership.html Fri, 05 Apr 2019 12:00:00 +0530 Myriad Genetics, a leader in personalized medicine has announced that it has expanded its companion diagnostic collaboration with AstraZeneca and Merck (known as MSD outside the US and Canada).   Under the expanded collaboration, the companies will use BRACAnalysis CDx® to identify germline BRCA mutations in men who have metastatic castrate-resistant prostate (mCRPC) cancer and are enrolled in the Phase III PROfound study. If the study is successful, Myriad intends to file a supplementary premarket approval application with U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as a companion diagnostic to Lynparza® (olaparib) for its use in this patient population.              Nicole Lambert, president, Myriad Oncology said, "Our companion diagnostic collaboration with AstraZeneca and Merck has led to significant advancements in precision treatment for patients with ovarian, breast cancer. However, there is a significant unmet medical need in men with metastatic castration-resistant prostate cancer and BRCA1/2 mutations, which is an area where the utility of PARP inhibitors is being explored.  We look forward to this exciting opportunity to potentially expand the use of BRACAnalysis CDx in this setting." The collaboration between Myriad and AstraZeneca on Lynparza began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.  On February 2019 the Japanese Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify patients with germline BRCA mutated (BRCAm) advanced ovarian cancer who are eligible for first-line maintenance therapy with Lynparza. On December 2018 FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with germline BRCAm advanced ovarian cancer in complete or partial response to first-line platinum-based chemotherapy and who are eligible for first-line maintenance treatment with Lynparza.  On March 2018 The Japanese Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify patients with germline BRCAm metastatic breast cancer who have been previously treated with chemotherapy and are eligible for treatment with Lynparza. On January 2018 FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with germline BRCAm metastatic breast cancer who have been previously treated with chemotherapy and are eligible treatment with Lynparza.  On August 2017 FDA approved BRACAnalysis CDx as a complementary diagnostic to identify patients with recurrent platinum-sensitive germline BRCAm ovarian cancer who are eligible for maintenance treatment with Lynparza.  On Dec. 2014 FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with advanced germline BRCAm ovarian cancer who have been treated with 3 or more lines of chemotherapy and are eligible for treatment with Lynparza.                                           ]]> https://biospectrumindia.com/news/97/13274/cyient-and-india2022-coalition-launch-medtechconnect-.html https://biospectrumindia.com/news/97/13274/cyient-and-india2022-coalition-launch-medtechconnect-.html Thu, 04 Apr 2019 09:00:00 +0530 This week saw the second annual gathering of leading business leaders, policy makers, academics and artists at the Xynteo Exchange/India2022 hosted at the Nehru Centre, Mumbai. The event saw inaugural address  by the Honourable Governor of Maharashtra, Shri C Vidyasagar Rao and keynote speech delivered by Dr Rajiv Kumar, Vice Chairman NITI Aayog. India2022 is a purpose-driven global business coalition committed to creating a new model of growth in India by 2022, the 75th year of India’s independence. The event showcased a number of initiatives that are addressing systemic transformation in energy, waste, healthcare and mining. A series of workshops involving some of the brightest minds from a wide range of specialisms and sectors worked on accelerating current India2022 projects. Combined, these aim to achieve a vision for a more sustainable and inclusive growth in India. Cyient and the India2022 coalition announced the launch of a new ecosystem platform, MedTechConnect. This innovative platform will bring together all medtech stakeholders to address India’s ‘last-mile challenge’ in healthcare, with the aim of touching millions of lives by 2022 and beyond. Currently, a large segment of India’s population does not have access to basic healthcare services, and nearly 80% of its medical technologies are imported. To combat this, MedTechConnect will work collaboratively with stakeholders to deliver disruptive medical technologies and catalyse innovative business models. India is home to a thriving technology ecosystem, yet more than 80% of its medical technologies are imported. A large segment of the country’s population still does not have access to basic healthcare services. The mission of MedTechConnect platform is to bridge this gap by delivering disruptive medical technologies that create a step-change in healthcare delivery to every corner of the country, while catalyzing innovative business models to minimize the cost and maximize the reach of these technologies. ]]> https://biospectrumindia.com/news/97/13261/veeda-clinical-research-achieves-iso-270012013-certification.html https://biospectrumindia.com/news/97/13261/veeda-clinical-research-achieves-iso-270012013-certification.html Wed, 03 Apr 2019 12:00:00 +0530 India's leading independent CRO, Veeda Clinical Research Pvt. Ltd. has announced that Bureau Veritas has awarded the ISO 27001:2013 Certification to Veeda Clinical Research thereby certifying the compliance of the company's Information Security Management System (ISMS) with the required international standards. The certified ISMS is enterprise wide covering Clinical, Bioanalytical, Biopharmaceutical, Medical Affair and Pharmacovigilance operations, Information and Communication Technology systems, processes and applications, Human Resources, Assets and Access management. On this important milestone, Mr. Apurva Shah, Founder and Director of Veeda Clinical Research, remarked, "Veeda consistently strives for Excellence in Quality and endeavours to become the partner of choice for our Sponsors and our Stakeholders. We continuously review and strengthen our policies, systems, processes and culture to be best-in-class and set industry benchmarks. The ISO 27001:2013 certification is yet another external validation of our commitment to Quality and a reassurance to our clients of our trustworthiness." "Veeda Clinical Research is committed to upholding the highest standards of information security to protect our sponsors' most sensitive information on which they run their business. By achieving the ISO 27001:2013 certification, Veeda has shown its commitment with all the necessary controls in place to ensure that data security and confidentiality is maintained," stated Dr. Venu Madhav - COO at Veeda Clinical Research. Mr. Rajesh Limbachia, Head-ICT at Veeda Clinical Research, added, "We have invested in the ISO 27001:2013 certification to provide additional transparency to our customers as it demonstrates our clear commitment to information security management and assures our sponsors that we have the requisite security controls in place to handle their data." Veeda Clinical Research was founded on the principles of Quality and achieving the ISO 27001:2013 certification further reaffirms Veeda's commitment to the quality of its systems and processes and provides the essential foundation for compliance with the European General Data Protection Regulation for protecting data privacy. ]]> https://biospectrumindia.com/news/97/13251/sri-sathya-sai-institute-of-higher-medical-sciences-gets-hematology-analyzer-from-transasia.html https://biospectrumindia.com/news/97/13251/sri-sathya-sai-institute-of-higher-medical-sciences-gets-hematology-analyzer-from-transasia.html Tue, 02 Apr 2019 12:35:00 +0530 Transasia Bio-Medicals Ltd., India’s Leading In-vitro Diagnostic Company has donated its newly launched hematology analyzer, H 360 to Sri Sathya Sai Institute of Higher Medical Sciences, Bangalore. This is in support of the institute’s most urgent need for essential instruments, for more precise diagnosis, faster treatment and improved outcomes. The H 360, is a three part differential fully automated hematology analyzer, developed at Transasia’s European subsidiary - Erba Europe. With its ability to detect CBC and WBC Differential with high precision and accuracy, H 360 will be useful in screening of anemia & its causes, indicating the presence of hemoglobinopathies, helping in detection of cytopenia, septicemia or leukemia and platelet related pathologies & disorders. Transasia has been closely associated with the institute for the last 25 years. Time and again, it has supported the institute with various dedicated initiatives such as blood donation drives, health check-up camps, providing the required equipment and contributing to fund-raising activities. Speaking on the occasion, Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals Ltd. said, “I am immensely proud of Transasia’s continuing association with the Sri Sathya Sai Institute of Higher Medical Sciences in aid of a very noble cause. The impact of the good work done by the institute has benefited not only the poor patients in Bangalore but also those from the nearby areas. At Transasia, we believe in operating with a higher purpose, with an unwavering focus on ensuring equitable and affordable access to diagnostic facilities. In the more than two decade long association with the institute, Transasia has provided its instruments to the institute. This latest version of theinstrument will be able to offer four more extra parameters for in-depth analysis." Dr. Sundaresh D C., Director, Sri Sathya Sai Institute of Higher Medical Sciences, added, “We are thankful to Mr. Vazirani and Transasia for supporting us with the analyzer. Transasia has a long-standing legacy of offering quality and affordable diagnostic solutions and I am sure that the additional parameters being offered by this new analyzer will provide more diagnostic value and aid in early and accurate diagnosis.” Alongwith the H 360, Transasia also announced the launch of two more 5 Part Differential Fully Automated Hematology analyzers, H 560 and Elite 580. Together this entire new range, with a host of features will help institutions, clinicians and laboratory technologists offer accurate diagnosis. The launch of these analyzers has come at an apt time, as Transasia celebrates its 40 th anniversary. ]]> https://biospectrumindia.com/news/97/13236/transasia-bio-medicals-gets-recognition-as-best-brand-2019.html https://biospectrumindia.com/news/97/13236/transasia-bio-medicals-gets-recognition-as-best-brand-2019.html Mon, 01 Apr 2019 12:05:00 +0530 Transasia Bio-Medicals Ltd., India’s Leading In-vitro Diagnostic Company, has been recognized as the ‘Best Brand 2019’ by The Economic Times, at a glittering ceremony held in Mumbai on 29th March, 2019. Organized by The Economic Times, world’s second most widely read business newspaper; the ‘Best Brand Award 2019’ is a recognition of the top 25 brands in the country from across different verticals. An extensive survey was conducted by The Economic Times and their knowledge partner Nielsen, across 15 industries in 12 tier I and II cities, spanning a sample size of 7500+ to identify the top brands. Transasia was the only In-vitro Diagnostic Company in the healthcare segment to win the award.    On receiving the award, Mr. Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals, stated, “This recognition comes at a time when we are celebrating our 40 years of dedicated service to doctors and patients in meeting their needs for quality and affordable diagnosis. Today, Transasia is not only a leader in its segment in India but also recognized as a global provider of quality diagnostic solutions. I am glad that we continue to live our legacy of Making in India for the world. I thank The Economic Times for this honor. We see it as an incentive to continually improve the brand by giving utmost satisfaction to our customers across the globe.” He further added, “I would also like to wholeheartedly thank my customers, business partners and patrons for their trust and support. We are committed to reaching out to meet the diagnostic needs of the emerging markets as we strive to build a healthier, happier world!” The Economic Times had earlier also bestowed Transasia with ‘The Best Healthcare Brand award’ in 2016. Early this year, Transasia was also honored by Medgate Today magazine as the ‘Best Company in  Medical Devices.’  ]]> https://biospectrumindia.com/news/97/13196/philips-india-expands-portfolio-in-ultrasound.html https://biospectrumindia.com/news/97/13196/philips-india-expands-portfolio-in-ultrasound.html Wed, 27 Mar 2019 11:15:00 +0530 Enhancing clinical performance and patient experience, Royal Philips, a global leader in health technology announced the launch of the EPIQ Elite ultrasound system, a new premium ultrasound that combines the latest advances in transducer innovation. EPIQ Elite offers a range of diagnostic ultrasound solutions tailored to the needs of specific medical specialties, including Philips’ first solution for vascular assessment and diagnosis. In addition, EPIQ Elite for Obstetrics & Gynecology delivers extraordinary image quality and lifelike 3D scans to provide advanced fetal assessment during all stages of pregnancy. The ultrasound features an exceptionally high level of clinical performance, workflow and advanced intelligence optimized for the most demanding clinical situations. Commenting on this innovative technology, Dr. Nidhi Bhatnagar, HOD, Radiology, Mata Chanan Devi Hospital, said, “The features in EPIQ Elite like FlexVue and MircoFlow imaging will give excellent results to the end users.” Adding to her, Dr. TSH Bedi, Director, Bedi Ultrasound, commented “The New Epiq Elite has a High Resolution HD Max screen which will bring excellent resolution. The new probes XL14-3,mC7-2,eL18-4 will take ultrasound to the next level of clarity. The C (Coronal) axis on real-time scan is amazing; there is no drop of frame rate & resolution.” Through this technology, Philips expects to equip clinicians with detailed information thereby resulting in diagnosis that is more confident. The advanced system combines new display technology (24inch HD Max monitor – 40% brighter than OLED technology) and innovative transducers (XL14-3, V9-2, L12-3 Ergo and mC7-2), enabling accurate outcomes as well as enhancing overall patient’s experience. Harnessing the power of advanced technologies with tailored clinical tools, the Elite delivers ultimate ultrasound solutions across clinical applications, especially for liver, breast, small parts and vascular assessments With imaging playing an important role within the care delivery spectrum, Philips’ latest integrated solutions across MRI, CT and ultrasound are built to enable radiologists in India to transform overall patient experience through faster and more accurate diagnosis. This new portfolio helps in obstetrics and gynecology by providing lifelike 3D scans which offer improved detection of birth defects and potential complications during all stages of pregnancy. The ergonomic, lightweight V9-2 transducer is the first high-frequency PureWave transducer focused on getting fine detailed images as early as possible to help clinicians easily perform confident assessments of fetal health. The xMATRIX linear transducer by Philips helps to produce 3D images of patient’s vasculature, which allows clinicians to see into a vessel to evaluate plaque location and composition as well as flow data to assess stenotic conditions. The system also allows clinicians to acquire two planes simultaneously, which the company said improves accuracy and can reduce exam time by 20%. Philips is a leader in ultrasound solutions with a large global installed base and strong record of accomplishment of industry-first innovations. The company’s ultrasound portfolio supports the effective and efficient delivery of care across a broad range of clinical specialties including radiology, cardiology, point-of-care and OB/GYN. ]]> https://biospectrumindia.com/news/97/13195/veeda-clinical-research-successfully-completes-third-inspection-by-npra-.html https://biospectrumindia.com/news/97/13195/veeda-clinical-research-successfully-completes-third-inspection-by-npra-.html Wed, 27 Mar 2019 10:55:00 +0530 Veeda Clinical Research Pvt. Ltd., a leading independent CRO has announced that its clinical (Shivalik, Ahmedabad) and Bioanalytical facilities (Insignia, Ahmedabad) have successfully completed the third inspection by NPRA (Malaysian Regulatory Agency). This was a routine study inspection by the NPRA to verify the compliance of the facilities and the studies with the principles of Good Clinical Practices and applicable Good Laboratory Principles. The inspection outcome confirmed Veeda's commitment to the highest Quality standards and compliance with the defined SOPs and regulatory guidelines. Veeda Clinical Research has successfully cleared 60 regulatory audits in the last 14 years including 19 USFDA Inspections of its facilities and clinical trial sites in last 24 months. With its focus on sustaining a strong Quality Culture that underscores its Quality Policy and robust Quality Management System, Veeda continues to steadfastly pursue its mission – 'To Strive for Excellence in Quality and endeavour to become the partner of choice for our Sponsors and our Stakeholders'.  ]]> https://biospectrumindia.com/news/97/13184/implandata-gets-ce-mark-for-next-generation-eyemate-system.html https://biospectrumindia.com/news/97/13184/implandata-gets-ce-mark-for-next-generation-eyemate-system.html Mon, 25 Mar 2019 16:30:00 +0530 Ophthalmic medical device company Implandata Ophthalmic Products GmbH (Implandata) successfully attained CE mark for its next generation EYEMATE-IO 1.1 implantable micro-sensor, which will be launched in April 2019. The CE-certified product enables eye surgeons to place the permanent implantable eye pressure sensor in conjunction with cataract surgery through significantly smaller incisions. The micro-sensor performs continual monitoring of eye pressure in glaucoma patients, providing highly critical information for guided glaucoma therapy. Intraocular pressure (IOP) monitoring is a considerable challenge for glaucoma patients and their ophthalmologists. Current IOP measurement methods require in-office procedures to be performed by trained medical staff. However, these measurements are obtained just a few times a year, although it is known that the eye pressure is highly dynamic and influenced by many parameters and, thus, changing throughout the day. Implandata is currently preparing for an initial market launch of its products at EYEMATE clinical ‘Centers of Excellence’ in Germany and Switzerland in 2019, followed by further internationalization in 2020 and the subsequent years. ]]> https://biospectrumindia.com/news/97/13172/fujifilm-india-yashoda-super-speciality-hospital-to-end-tb-together.html https://biospectrumindia.com/news/97/13172/fujifilm-india-yashoda-super-speciality-hospital-to-end-tb-together.html Mon, 25 Mar 2019 10:10:00 +0530 Fujifilm India in partnership with Yashoda Super Speciality Hospital, Kaushambi, Ghaziabad, organized an awareness program ‘TOGETHER END TB’ to help eradicate tuberculosis in India. The event was held in New Delhi recently to mark the World TB day. According to WHO’s Global TB report, Tuberculosis is the 10th leading cause of death worldwide, and since 2011 it has been the leading cause of death from a single infectious agent, ranking above HIV/AIDS and claiming over 4000 lives a day. India has the highest number of TB cases in the world at 27% of the 10 million people who developed the disease in 2017 globally. The situation in India is primarily due to the patients suffering from undetected tuberculosis for too long; late detection of disease which increases their risk of transmitting the disease to others. While the burden of the disease is declining slowly worldwide, the progress in controlling disease and mitigating its consequences is extremely imperative in India. To expedite the cause, continuous and conscious efforts need to be taken for early diagnosis and treatment. Commenting on the occasion, Haruto Iwata, Managing Director, Fujifilm India Pvt. Ltd. said, “Our association with Yashoda Super Speciality Hospital is in line with our endeavour to fight against Tuberculosis in India. The correct education and awareness from Hospitals and doctors is a crucial first step and can significantly contribute to the government’s vision of completely eradicating the disease from the country by 2025.” Understanding this need, Fujifilm India looks to contribute towards the wellbeing of the people who are suffering from the disease and yet are unaware of its repercussions. The main objective of the program TOGETHER END TB is also to emphasize that incomplete or delayed treatment can lead to serious complications or fatalities. Further throwing light on the importance of early diagnosis of TB, Upasana Arora Director Yashoda Super Speciality Hospital said “The longer the disease is left undetected, the higher the chance that the patient will end up transmitting the infection in the community. With our joint efforts with Fujifilm, we look at addressing the issue in order to achieve the goal of ‘End TB’ in India.” The program also encourages patients in India to complete their treatment cycle as ignorance or complacency can lead to MDR TB, which is even more dangerous and often not treatable. Explaining the objective of the program,  Chander Shekhar Sibal, Senior Vice President, Head of Medical Division, Fujifilm India Pvt. Ltd. said, “In India, every year around 2.8 million people develop this disease with nearly 40% of them being infectious. Today’s program is our effort along with Yashoda Super Speciality Hospital to raise consciousness and promote advanced diagnosis and treatment of tuberculosis among patients.” Dr. Sunil Dagar General Manager - Operations & Quality talking about the roadmap to deal with the problem said, “Mapping the disease will help in predicting, preventing and treating a number of cases in the community. The collaboration will open up new possibilities and help in generating awareness among the masses.” Fujifilm India in association with Yashoda Super Speciality Hospital, distributed 1000 coupons for free chest X- Rays and TB check-ups. The installation of the Fujifilm’s Digital Radiography System ‘FDR Smart f’ at the hospital will help in efficient workflow and excellent image quality for the better diagnosis of Tuberculosis.   ]]> https://biospectrumindia.com/news/97/13126/bd-set-to-market-its-venovo-venous-stent-.html https://biospectrumindia.com/news/97/13126/bd-set-to-market-its-venovo-venous-stent-.html Mon, 18 Mar 2019 13:05:00 +0530 BD (Becton, Dickinson and Company), a leading global medical technology company, announced the U.S. Food and Drug Administration has granted premarket approval for the Venovo™ venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin. The Venovo™ venous stent is a flexible nitinol stent specifically designed to reopen blocked iliac and femoral veins in order to maintain adequate blood flow. The Venovo™ venous stent is designed with a balance of radial strength, compression resistance and flexibility needed for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. Additionally, the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths. Iliofemoral venous occlusive disease occurs when there is impaired blood flow in the iliofemoral vein caused by acute or chronic deep-vein thrombosis, post-thrombotic syndrome, iliofemoral vein compression including May-Thurner Syndrome or a combination of these diseases. Symptoms include swelling of the legs, pain when standing, skin discoloration and ulcers.  One-year results from the prospective, multicenter single-arm VERNACULAR trial involving 170 subjects demonstrated the safety and effectiveness of the Venovo™ venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction. The clinical findings showed a weighted primary patency rate of 88.3 percent, with a 96.9 percent patency rate in non-thrombotic lesions and an 81.3 percent patency rate in post-thrombotic lesions at 12 months, exceeding the performance goal of 74 percent. In addition, patients treated with the Venovo™ venous stent reported a statistically significant reduction in pain symptoms and improvement in quality of life (assessed by CIVIQ-20) at 12 months from baseline. The Venovo™ venous stent was also deployed successfully to the target lesion and showed adequate coverage in all cases, and there were no fractures seen at 12 months. The Venovo™ venous stent is commercially available in the U.S., Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore and Taiwan. ]]> https://biospectrumindia.com/news/97/13125/alcon-acquires-powervision-to-make-intraocular-lens-implants.html https://biospectrumindia.com/news/97/13125/alcon-acquires-powervision-to-make-intraocular-lens-implants.html Mon, 18 Mar 2019 12:10:00 +0530 Alcon, the global leader in eye care and a division of Novartis has acquired PowerVision, Inc., a privately-held, US-based medical device development company focused on creating fluid-based intraocular lens implants. The acquisition furthers Alcon's commitment to bring this innovative, accommodating lens to cataract patients throughout the world. Commercial availability of PowerVision's IOL technology will be determined following significant additional development and clinical trials of the intraocular lens. PowerVision's unique lens design utilizes the eye's natural accommodating response to transport fluid in the intraocular lens which is implanted in the eye's capsular bag. While most presbyopia-correcting intraocular lenses use a multifocal design that distributes light between different focal points, PowerVision's groundbreaking fluid-based design creates a continuously variable monofocal lens, utilizing the natural contraction of the eye's muscles. This technology allows the patient to actively focus on objects, just as the natural crystalline lens does in a youthful eye, providing patients with a natural, continuous range of vision. While basic, monofocal IOLs are most commonly used for cataract surgery, AT-IOLs, including those that correct presbyopia, are improving patient outcomes and fulfilling desire among patients for spectacle independence. Alcon leads the industry in global IOL share and estimates double-digit growth in AT-IOLs, largely driven by new innovations. Under the terms of the agreement, Alcon paid USD 285 million to PowerVision at closing with additional payments based on specified regulatory and commercial milestones starting in 2023.  ]]> https://biospectrumindia.com/news/97/13117/philips-india-reinforces-commitment-to-sleep-health.html https://biospectrumindia.com/news/97/13117/philips-india-reinforces-commitment-to-sleep-health.html Fri, 15 Mar 2019 15:00:00 +0530 Strengthening its commitment to ‘Sleep Health’, Royal Philips, a global leader in health technology has released India findings from its annual global sleep survey titled, “The Global Pursuit of Better Sleep Health.” As a leading innovator in sleep and respiratory care, Philips aims to use these insights to further enhance conversation about an important yet often forgotten pillar of health and wellbeing: sleep health. The survey, executed by KJT Group on behalf of Philips, interviewed 11,006 respondents in Australia, Brazil, Canada, China, France, Germany, India, Japan, Netherlands, Singapore, South Korea, and the United States to capture attitudes, perceptions, and behaviors around sleep. Key findings from India include: Despite 55% of Indian adults agreeing that they sleep well, 73% still wants to improve the quality of their sleep Indicating rise in awareness level on ‘Sleep-Health’, 38% of Indian adults say that their sleep has improved in the past 5 years, the highest number of all countries. While 34% Indian adults are inclined to know more sleep and treatments to improve sleep, 24% have already used online forum/social media to better educate themselves about ‘Sleep Health’. When it comes to improving sleep, 31% Indian adults meditate, higher than the global average of 26%. Interestingly, the findings also point out to an appetite of using sleep improvement tech/wearables with 16% Indian adults inclined to use the devices as wearable technology allows consumers simple ways to monitor and improve their sleep quality. Indicating ignorance about sleep disorders, the survey also highlighted that nearly half of the sufferers perceive snoring to be natural, hereditary, or caused by age which is a major reason to not take it seriously. Philips has established over 500 sleep labs across the country and trained over 400 sleep technicians. It is developing clinically-proven solutions that help people take control of their sleep health. It is also meeting the growing and evolving needs of consumers and healthcare professionals, through the expansion of its SmartSleep suite of solutions and surpassing of ten million DreamWear masks and cushions sold worldwide. ]]> https://biospectrumindia.com/news/97/13105/axio-biosolutions-announces-world-class-scientific-advisory-board.html https://biospectrumindia.com/news/97/13105/axio-biosolutions-announces-world-class-scientific-advisory-board.html Thu, 14 Mar 2019 20:00:00 +0530 India’s leading innovative med-tech company, Axio Biosolutions, is all set to step up its US launch plans with the announcement of its top-notch Scientific Advisory Board. As the first-ever Indian company to get USFDA clearance for a haemostat, Axio is well poised to disrupt the wound care industry globally. The Bengaluru-based enterprise has appointed Dr Shiladitya Sengupta, Assistant Professor of Medicine at Harvard Medical School, as Chairman, and Dr S V Mahadevan, Professor of Emergency Medicine at Stanford University, as member of its Scientific Advisory Board. The appointments are a testament to Axio’s unwavering commitment to bring the latest scientific and technological innovation into the wound care and surgical market. An alumnus of the All India Institute of Medical Sciences, where he received the Geeta Mital Gold Medal, Dr Sengupta serves as Assistant Professor of Health Sciences and Technology at MIT, and principal investigator at the Dana- Farber Cancer Institute, Boston. After completing his PhD at Trinity College, University of Cambridge (where he was a Nehru Scholar as well as a British Chevening Scholar) and a fellowship in Biological Engineering from MIT, Dr Sengupta joined the Harvard faculty. The co-founder of Akamara Therapeutics (hitherto Invictus Oncology), Vyome Biosciences, Mitra Biotech and Cerulean Pharma Inc. (served on the Scientific Advisory Board), Dr Sengupta, has also co-chaired the Center for Regenerative Medicine at the Brigham and Women’s Hospital in Boston. He has been the recipient of several prestigious awards, including the TR35 Innovator Award by MIT Technology Review magazine; the Era of Hope Scholar Award and the Innovator Collaborative Award from the US Department of Defense; the Coulter Foundation Career Award; and the Shakuntala Amir Chand Award from the Indian Council for Medical Research. Axio’s other notable appointment, Dr S V Mahadevan, Professor of Emergency Medicine at Stanford University, Palo Alto, California, brings critical expertise of over 23 years in emergency medicine to the Scientific Advisory Board. The founding chair of the Department of Emergency Medicine at Stanford (2015-17) and founding Director of Stanford Emergency Medicine International (2000-2015), Dr Mahadevan currently serves as both the Director of Global Affairs and Strategy for Stanford Medicine as well as the Director of South Asia Outreach, Center for Asian Health Research and Education (CARE). Dr Mahadevan has received numerous esteemed teaching awards throughout his illustrious career, and is the lead editor of the textbook, An Introduction to Clinical Emergency Medicine, which won the 2006 American Medical Writer’s Association Award in the Physician’s Category. Currently, he is a teaching physician at Stanford Health Care. ]]> https://biospectrumindia.com/news/97/13082/organization-de-scalene-launches-cryogenic-device-to-treat-piles.html https://biospectrumindia.com/news/97/13082/organization-de-scalene-launches-cryogenic-device-to-treat-piles.html Wed, 13 Mar 2019 10:45:00 +0530 Dr. Rajah Vijay Kumar, Group Chairman of Organization de Scalene, recently announced the launch of Cryocure, an affordable medical device to treat piles without surgery, in the presence of the Chief Guest, Dr. T.S. Prabhakar, Director of Health and Family Welfare Services. Cryocure is made of unbreakable medical plastic. The device must be frozen for two hours before use. Once removed, the cold Cryocure is dipped in coconut oil or Vaseline for lubrication before inserting into the anus at a temperature of -18 degrees C. The Cryogenic effect causes blood vessels of the hemorrhoids to constrict thus making them shrink. With regular use pain, itching, burning and blood loss gradually disappears. This treatment can be done in the comfort of your home. “Hemorrhoids is the most misused disease across the world. In India mostly quacks are treating Piles and Fistula. Many lives have been lost and deaths caused due to unqualified treatment of hemorrhoids. With Cryocure, we have a cost-effective cure at home”, said Dr. Prabhakar. Dr. Rajah explained, “Hemorrhoids if untreated can lead to a bigger problem and also pose serious medical risks. Cryocure is a simple tube-like device filled with special Cryogenic memory agent. It is priced reasonably so it is affordable and can cure hemorrhoids without any surgical procedure or side effects. It is also safe for usage among pregnant women, diabetic and heart patients. Hemorrhoids are a common occurrence during pregnancy with nearly 40% pregnant women on the planet suffering from it. For all these reasons, it has received widespread acceptance in North Indian cities''.    The device was initially launched at a small scale in Delhi, Punjab and Haryana few months back. After gathering a positive response in the north, Cryocure has now been launched in Karnataka. The device is priced at Rs 6900 and is currently available at a few chemist stores in Karnataka. Orgreen Health Care is the distributor for the device in Karnataka currently.   ]]> https://biospectrumindia.com/news/97/13036/opto-circuits-expects-to-grow-at-25-during-the-current-year.html https://biospectrumindia.com/news/97/13036/opto-circuits-expects-to-grow-at-25-during-the-current-year.html Fri, 08 Mar 2019 14:20:00 +0530 Opto Circuits India, the leading global medical devices and technology group with a diversified product portfolio, dealing in products like vital signs monitoring, emergency cardiac care, vascular treatments and sensing technologies expects to grow at 25% during the current year. The company has already achieved last year revenues in the first three Quarters [April to Dec 2018]of the year and expected to deliver good fourth quarter performance. This would result in 25% growth in revenues and profitability of the company during the current year. The company has undergone various market related challenges across the geographies and is fairly able to come out of majority of them and had started fresh life last year with a profit of Rs. 35 crore and revenues of Rs. 225 core. Going forward the company is expecting good growth from both domestic and international business. The company’s subsidiaries also seeing good flow of orders. The Indian medical device market is growing steadily and it is valued at US $4.8 billion. With the company’s focus on driving organic growth in India and with the Indian medical device industry though in its nascent stages shows great potential for the company. Other factors like strong private healthcare system, growing middle class with increasing income levels, change in the disease profiles (lifestyle diseases), greater penetration of health insurance, Government focus on healthcare infrastructure development and arising awareness of personal health care the company sees a great scope for its growth in India. Currently the company along with its subsidiaries are engaged in the design, development, manufacture, marketing and distribution of a range of medical products that are used by primary, secondary and tertiary healthcare establishments as well as in public access facilities such as schools, fire stations, policy offices in over 150 countries. The company specializes in vital signs monitoring, emergency cardiac care, vascular treatments and sensing technologies. The US FDA listed and CE marked products are manufactured in India, Malaysia, Germany and the United States. The company’s biggest competitive advantages is the propriety technology developed by the  in house teams which gives the company the control over features and intellectual property costs of devices and helps minimize their dependence on third party technologies. The focus on research and development activities has enabled the company to develop devices which are technologically superior to other devices available in the market. Commenting on the development, Mr. Vinod Ramnani, Chairman, Opto Circuits India said, “As India's economic, healthcare, and social landscapes evolve, its medical device market emerges as a promising opportunity for manufacturers like us. Also, with medical tourism and luxury healthcare markets are among India's fastest growing industries, which create significant demand for specialized, high-tech medical equipment. We have streamlined all our businesses and on the path of delivering healthy growth for the next two to three years.” ]]> https://biospectrumindia.com/news/97/13022/medical-electronics-market-to-exceed-169-b-till-2025.html https://biospectrumindia.com/news/97/13022/medical-electronics-market-to-exceed-169-b-till-2025.html Thu, 07 Mar 2019 11:50:00 +0530 The Medical Electronics Market is set to grow from its current market value of more than $73.3 billion to over $169 billion by 2025; as reported in the latest study by Global Market Insights, Inc. Availability of medical equipment and devices on lease will escalate its demand among healthcare professionals thereby positively influencing the industry growth. Most of the medical electronics available in market are expensive due to integration of advanced technology. Hospitals, diagnostic centers and individual medical practitioners are reluctant to buy them due the huge investment required, and it takes good amount of time to recover the cost. The direct purchase cost of technologically advanced medical devices is high, and the cost of entire healthcare setup can rise steeply. Rising adoption of technologically advanced medical electronic devices in emerging economies such as India and China will significantly boost the industry growth during the analysis period. Although the medical electronic devices are expensive, several government initiatives and favorable FDI policies will trigger the adoption of these devices among the healthcare professionals. However, stringent regulations enforced on the companies involved in manufacturing of medical electronic devices will restrain the industry growth in the forthcoming years. Respiratory care devices segment was valued over USD 6 billion in 2018 and is expected to have considerable revenue size during the forecast timeframe. Growth can be attributed to the increasing prevalence of respiratory diseases such as COPD and asthma. According to Global Asthma Network, asthma kills around 1000 people every day globally that surges the demand for respiratory care devices thereby propelling segmental growth in foreseeable future. Clinics segment will experience 13.2% growth during the forecast timeframe. Considerable segmental growth will be as a result of high adoption rate for medical electronic equipment due to the advent of innovative and cost-effective devices. For instance, ultrasound equipment typically designed for hospitals are now being deployed at clinics. The portable ultrasound machine cost less than full sized equipment. Cost containment pressure from regulatory authorities is driving innovation aimed at introducing cost effective devices with improved performance that will boost the segment growth. China medical electronics market witnessed 13.4% growth during the analysis period and is anticipated to grow exponentially over forecast timeframe. Growing geriatric population is expected to drive the growth. According to China News Service, by the end of 2017, there were around 241 million people in the age group of 60 years and above. Majority of the elderly population base suffers from chronic ailments that raise the demand for medical electronics accelerating the industry growth.      Germany medical electronics market accounted for 27.6% revenue share of Europe market. Technological integrations by the local players operational in medical electronics market have ensured country share. Additionally, the regulations raise entry barriers for the new industry player to establish themselves in Germany that is beneficial for the local players for earning sustainable profits. Key industry players operational in medical electronics industry include Allengers Medical,Boston Scientific, Carestream Health, FUJIFILM Medical Systems, GE Healthcare, Hitachi High Technologies, Corporation Maxim Integrated, Medtronic, Olympus Corp., Philips Healthcare and others. These players implement several strategic initiatives such as collaborations, new product launch, mergers and acquisitions to acquire potential market share. ]]> https://biospectrumindia.com/news/97/13001/dr-lal-pathlabs-collaborates-with-ordi-to-sensitize-india-on-rare-diseases.html https://biospectrumindia.com/news/97/13001/dr-lal-pathlabs-collaborates-with-ordi-to-sensitize-india-on-rare-diseases.html Tue, 05 Mar 2019 15:55:00 +0530 Observing Rare Disease Awareness day on 28th February 2019, Dr. Lal PathLabs Ltd. has associated with Organization of Rare Disease India (ORDI) for a campaign “RARE NEEDS CARE”. Dr. Lal PathLabs has been working towards the cause and combating rare diseases of neurology through its NeuroPro division. Commenting on the association, (Hony) Brig Dr Arvind Lal, Chairman & Managing Director, Dr. Lal PathLabs Ltd. said, “We are honoured to collaborate with ORDI. Through this event we aim to make people aware about the challenges patients face due to rare diseases. We are participating in the event as associate sponsors to spread awareness about these rare diseases and help these patients get a correct & timely diagnosis.” In India, 70 million people suffer from rare diseases which means 1 out of 20 children is diagnosed with rare disease. Racefor7 is an event organised by Organization of Rare Disease India (ORDI) to empower patients and their families with access to national and international resources. To raise awareness for the 7,000 documented rare diseases, the event consists of a 7,000 m walk. This year the event is speard across 9 cities viz Mumbai Bengaluru, Kolkata, Chennai Mysuru, Coimbatore, Kochi, New Delhi and Thiruvananthapuram. ]]> https://biospectrumindia.com/news/97/12990/bayer-launches-next-gen-ct-injector-medrad-centargo.html https://biospectrumindia.com/news/97/12990/bayer-launches-next-gen-ct-injector-medrad-centargo.html Mon, 04 Mar 2019 17:55:00 +0530 Bayer recently revealed its new MEDRAD™ Centargo CT injection system at this year’s European Congress of Radiology (ECR) 2019, taking place from February 27 – March 3 in Vienna. The latest addition to Bayer’s range of imaging products, which is expected to receive CE certification this summer, has been developed with the aim of meeting one of the most pressing needs of radiology departments today: doing more with less.  “With a continuously increasing number of patients and sometimes quite complex CT procedures, what we need are product innovations that simplify our workflow and allow us to focus on the quality of the image and most importantly the patient,” said Dr. Casper Mihl, Head of the CT Department and Abdominal and Cardiovascular Radiologist at Maastricht University Medical Center. Key features of MEDRAD Centargo include a daily set-up process that can be completed in less than 2 minutes and a snap-in patient line that is ready for the next patient in less than 20 seconds. Furthermore, the piston-based technology of Centargo has been designed to provide quality fluid delivery, even during the most demanding protocols.  The integrated barcode reader reduces manual data entry and provides easy traceability and access to contrast and injection details. “We have been working in partnership with radiologists to create a new CT injector that meets the demands faced by modern radiology departments,” said Prof. Dr. Olaf Weber, Head of Radiology Research and Development at Bayer. “Centargo offers innovative technology and design that increase efficiency and improve workflow through less manual work and touch time, allowing Radiology teams to spend more time where it matters most – with their patients.” ]]> https://biospectrumindia.com/news/97/12980/genes2me-driving-innovation-with-genetic-testing-and-health-checkup.html https://biospectrumindia.com/news/97/12980/genes2me-driving-innovation-with-genetic-testing-and-health-checkup.html Mon, 04 Mar 2019 10:45:00 +0530 In the crowded preventive health segment space, there are thousands of labs offering routine full body checkups. These packages claim to provide a 'preventive' health picture for all individuals. However, these checkups are merely a state of one's current parameters. In other words, a normal full body checkup report only provides information on some of the health parameters about today’s health and does not provide any insight about upcoming health issues which one could prevent while being healthy. This is one of the most important aspect for people doing a preventive health test in first place.  Genes2Me, a diagnostic company with a focus on genetic testing, is trying to change this one size fits all approach to the preventive healthcare segment. For the first time in the world, Gurugram based Genes2Me lab is approaching preventive healthcare in a truly personalized manner. Genes2Me has coupled a full body checkup with a genetic test to provide insight about one's present and future health. These tests can tell an individual they could be at a much higher risk for developing deadly disorders later in their lifetime. The company aims to offer this information about one's health today so that they can take appropriate steps to secure a healthy future. Keeping innovation at the forefront, Genes2Me has applied advanced genetic testing technologies into all areas of diagnostic testing in order to bring a change in the preventive healthcare market. Through its tests such as Genes2Fit, they provide a personalized genetic report which provides information about factors such as fitness and exercise, diet patterns, vitamin requirements, food reactions, and metabolism. The lab also provides a valuable matching diet tailor-made to an individual's genetic makeup. Genes2Me expert genetic counselors guide the customers through their report and provide an in-depth review of their genetic report. Genes2Health, one of the advanced tests, profiles an individual's risk to a multitude of lifestyle-related disorder such as certain cancers, diabetes, cardiac disorders, and arthritis. Genes2Fit and Genes2Health tests are also coupled with a routine full body checkup. Thus, by linking the present medical picture of an individual to his future health profile, Genes2me aims to provide an effective futuristic clinical solution. One of the tests, Med4Me, provides information about an individual's tolerance to certain medicines. This test can inform you about adverse reactions and the effectiveness of prescribed medicines. Armed with this information, an individual can bring out lifestyle changes which could reduce their risk of diseases and adverse reactions. With the inclusion of genetics in routine diagnosis and genetic counseling, Genes2Me offers an advanced and technologically driven solution at very cost-effective pricing. Neeraj Gupta, CEO, Genes2Me, emphasizes, "In India's regressive health delivery system, in which major health expenses on diagnostic testing are met by out-of-pocket spending, Genes2Me empowers individuals through comprehensive health data which is cost effective and clinically valuable. This approach has been designed to address a healthy today and nurture a healthier tomorrow." Genes2Me's services empower an individual to take better control by providing a complete and futuristic perspective of their health. Its efficient and effective diagnostic solutions are a step towards the next level of diagnostics by harnessing the power of genetic testing. Genes2Me tests are truly preventive and personalized solutions for one's wellbeing. ]]> https://biospectrumindia.com/news/97/12952/merck-launches-fertility-technologies-in-india-.html https://biospectrumindia.com/news/97/12952/merck-launches-fertility-technologies-in-india-.html Wed, 27 Feb 2019 19:35:00 +0530 Merck has launched its fertility technology in India recently. The business launched two devices, namely Geri® and Gavi®, as well as Gems®, a complete culture medium suite. This will be made available in partnership with Genea Biomedx, to IVF clinics and hospitals. This new technology provides an environment that helps to reduce external stresses on the embryos of patients undergoing fertility treatment. Individually-controlled chambers allow the embryos of each patient to grow separately and real-time cameras attached to each chamber reduces the frequency of opening and closing the chambers in Geri®. Not only does this allow observation of the progress of embryo growth without removing the embryo from the chamber, it also reduces the impact on the embryo of factors such as changes in gas concentration and temperature. Anandram Narasimhan, General Manager –India Cluster, Merck Biopharma said, “Merck has a market-leading portfolio of drugs and offers an array of clinic optimization services. Fertility lab procedures involve various steps and variables which can impact the overall success rate of IVF treatment. The introduction of cutting-edge fertility technology complements our portfolio and promises to decrease manual labor, increases precision and thus optimizes IVF outcomes for patients in India. Studies say nearly 27.5 million* Indian couples are actively seeking solution for infertility and with this technology are in position to offer them better access to world class treatment.” Gavi® is the automated vitrification instrument, developed with the aim to achieve a consistent and standardized vitrification process. Geri® is a benchtop incubator with individually controlled incubation chambers per patient to minimize disruptive events to the early-stage embryo. It also incorporates a time-lapse camera to capture images of embryos as they develop. Gems® is the latest generation of Genea Biomedx’s culture media suite for high-quality embryo cultivation. Gavi®, Geri® and Gems® are created by Genea Biomedx, a company that creates and manufactures practical, accessible and precise fertility technologies that help standardize and automate fertility treatment.     ]]> https://biospectrumindia.com/news/97/12942/find-joins-carb-x-in-fight-against-amr.html https://biospectrumindia.com/news/97/12942/find-joins-carb-x-in-fight-against-amr.html Tue, 26 Feb 2019 21:30:00 +0530 The Foundation for Innovative New Diagnostics (FIND) and the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) have announced that FIND is joining the CARB-X Global Accelerator Network. The CARB-X Global Accelerator Network now includes 10 organizations, providing business, scientific, and technical expertise and services to CARB-X-funded companies to support their antibacterial research projects. FIND will play a leading role in supporting CARB-X diagnostic investments around the world, and in supporting new applicants for CARB-X funding for the development of diagnostics. FIND will also be positioned to help companies assess how diagnostic solutions could be used in resource-poor settings. Joining the network enhances FIND’s unique view of the global antimicrobial resistance (AMR) diagnostics pipeline, allowing FIND’s own diagnostic development investments to be strategically aligned with global unmet needs. ]]> https://biospectrumindia.com/news/97/12940/transasia-receives-accolades-from-medgate-today-.html https://biospectrumindia.com/news/97/12940/transasia-receives-accolades-from-medgate-today-.html Tue, 26 Feb 2019 21:10:00 +0530 Transasia Bio-Medicals Ltd., India’s Leading IVD Company, recently announced that it has been adjudged the ‘Best Company in Medical Devices’ by Medgate Today, an international healthcare magazine, with a strong presence in Asia and Middle East.      Transasia was selected the winner, from among other leading names in the industry, based on a primary research by the magazine. The award is a recognition given to companies with outstanding services and contribution to the healthcare sector. This is the second consecutive year that Transasia has been receiving the award in the same category. The award was presented at a grand ceremony on 22nd February, 2019 and attended by some of the most well-known names of the industry. On receiving the award, Suresh Vazirani, Chairman & Managing Director, Transasia, said “I am thankful to the jury members for recognizing Transasia as the Best Medical Device Company for the second year in a row. We are doubly delighted as this prestigious award comes our way, as we celebrate our 40th anniversary. For the last four decades, Transasia has been committed to offering laboratory testing instruments of the highest quality to meet the needs of the country for affordable diagnostics. We pride ourselves in offering the strongest service network in the country, from the largest city to the smallest town. We are thankful to the medical fraternity who trust us in offering their patients early and accurate diagnosis.” The award ceremony was preceded by the Voice of Healthcare (VOH) Conference 2019 held at Pragati Maidan in New Delhi. The fourth edition of this international conference focused on ‘Viable Healthcare for All’ against the backdrop of disruptions and constraints of healthcare delivery system. This conference assumed strategic significance as participants from the healthcare and medical technology segment shared their practical approach while dealing with various issues. During the panel discussion on ‘Affordable Access to Medical Devices’, Mrs. Mala Vazirani, Executive Director, Transasia Bio-Medicals Ltd. highlighted the impact of technology on healthcare. “Technological innovation is critical to expanding the reach of medical services, lowering costs of deployment and improving patient outcomes,” she said. Transasia has been meeting India’s needs for essential diagnosis through affordable and innovative, Made in India products and solutions. Today, it boasts of over 65,000 installations in 35,000 labs across India and reaching out to millions in more than 100 countries worldwide. Through its R&D centres in India and abroad, Transasia has developed world-class technology for a wide range of products and solutions in Clinical Chemistry, Hematology, Immunology, Diabetes Management, Urinalysis, Coagulation, Critical Care and Microbiology. Into its 9th edition, the Medgate Today awards, evaluates hospitals, companies & healthcare professionals on their outstanding performance in the healthcare and life sciences sector. It recognizes doctors & Hospitals that have demonstrated best practices in a variety of regional and global markets.   ]]> https://biospectrumindia.com/news/97/12913/ahpi-aimed-collaborate-to-promote-indian-medical-devices-industry.html https://biospectrumindia.com/news/97/12913/ahpi-aimed-collaborate-to-promote-indian-medical-devices-industry.html Mon, 25 Feb 2019 10:05:00 +0530 Association of Healthcare Providers of India (AHPI) and Association of Indian Medical Device Industry (AiMeD) recently signed a memorandum of understanding (MoU) to support Make in India of Medical Devices to transform India into a global medical devices manufacturing hub and simultaneously promote the India Certification of Medical Devices Scheme (ICMED) country’s first indigenously developed international class quality assurance system for India manufactured medical devices.  The MoU was signed by Mr. Rajiv Nath, Forum Coordinator, AiMeD and Dr. Girdhar Gyani, Director General, AHPI.  As per the MoU, AHPI and AIMED will work together to jointly promote Indian Medical Devices Industry and specially promote ICMED (from Quality Council of India) certified products in over 10000 member Indian hospitals aimed at enhancing patient safety, increasing consumer protection along with providing much needed product credentials to manufacturers to instill confidence among buyers. The scheme is also intended to significantly eliminate trading of sub-standard products or devices where supply chains are unknown, a widespread and injurious occurrence in the Indian market.  The move is likely to have a huge positive impact on 'Make in India' program while giving a big shot to manufacturing of medical devices within the country, promote Medical Devices manufactured in India as high quality products, promote “Buy Indian” initiatives and bring esteem to the Indian Industry & Nation thereby building Brand India.  Both AHPI and AIMED recognize specifically the need for setting up of an independent, multi stakeholder governing structure for the Scheme(s). AHPI shall operate the Scheme(s) by setting up independent multi-stakeholder steering committee(s) and any other committees necessary for the purpose in consultation with AiMeD. AiMeD shall provide the technical documents developed by by QCI for ICMED quality management system certification and ICMED Plus product certification to AHPI for enabling 1 Step Beyond Endorsement and shall provide all technical support to AHPI in managing and promoting the Scheme(s). Under the joint mechanism, both associations will soon roll out activities to achieve the objectives of this MoU. ]]> https://biospectrumindia.com/news/97/12910/medical-fair-india-2019-starts-with-over-250-indian-exhibitors.html https://biospectrumindia.com/news/97/12910/medical-fair-india-2019-starts-with-over-250-indian-exhibitors.html Fri, 22 Feb 2019 19:20:00 +0530 The 25th Medical Fair India was inaugurated by Devender Singh, Advisor to Minister Ashwini Kumar Choubey  at the Pragati Maidan Exhibition Center in New Delhi with a total of 600 exhibitors and more than 250 Indian exhibitors this year. Medical Fair India 2018 in Mumbai, 16 – 18 March saw 12,350 trade visitors and this year it is expected to cross 15,000 trade visitors. New additions to this year’s Fair are Digital Healthcare by Future for Health, Reha India (powered by REHACARE) with ranges for rehabilitation and nursing care, VoH & CliniLab conference , a 2-day conference dealing with various cross-sector topics related to the implementation of a modern healthcare system and Technology Mela by Kalam Institute of Health care technology where 75 innovative technologies from 20 academic institutions will be displayed for commercialization. Alongside this new area other focal segments on display at MEDICAL FAIR INDIA 2019 included: medical products and devices, laboratory technology and diagnostics, clinic and health centre furniture, and the health IT segments now so on trend the world over as well as mobile health solutions.  Rajiv Nath, Forum Coordinator, AiMeD said, “India is one of the fastest growing country in Medical & Healthcare Sector. Medical Fair India provides plenty of opportunity for interacting with people of different trade and business at a single place to set up profitable business relationships and keep abreast with accessible technologies.” Addressing International Conference at MFI 2019, Rajiv Nath, “Medical Fair India is getting bigger and better with every edition. With MFI 2019, we seek  Medical Devices Law to regulate quality and ensure patient safety, revision of DPCo to enable rationalised price controls to protect consumers by capping trade margins over import landed, tariff at 15-20% to be in line with mobile phone so that make in Indian can prosper along with other regulatory framework, favourable policies and ecosystem support.  We invite colleagues and fellow exhibitors of this global village to invest in India by technical collaborations, Joint Ventures and own factories to explore this incredible market place.” “We hope that Medical Fair India can become the preferred Healthcare Exhibition for Indian Medical Devices Industry and rise to the levels of Arab Health, Dubai and Medica, Germany, one day”, he added.  Ashwini Kumar Choubey, Minister of State for Health and Family Welfare in a message to MFI 2019 said, “The objective of the Fair is to see some of the key experts from the medical fraternity delivering inspiring talks and are also going to be conferred with awards for their valuable contribution to the healthcare field. I am confident that such recognition will not only give enough encouragement but will give new impetus in the overall growth of the healthcare sector while being mutually beneficial for the healthcare professionals who will congregate on the occasion.” Rajiv Nath also highlighted key recommendations to place India among the Top 5 Medical Devices manufacturing hubs worldwide and end the 70-90% import dependence forced upon us and an import bill of over Rs 31, 000 crore: Medical Devices Law to regulate quality and ensure patient safety Revision of DPCO to enable rationalised price controls to protect consumers by capping Trade Margins over import landed and Ex -factory price Tariff at 15-20% to be in line with mobile phone so Make in Indian and Made in India will prosper.     ]]> https://biospectrumindia.com/news/97/12909/trutest-labs-holds-preventive-health-check-up-camp-in-mumbai.html https://biospectrumindia.com/news/97/12909/trutest-labs-holds-preventive-health-check-up-camp-in-mumbai.html Fri, 22 Feb 2019 18:55:00 +0530 In a bid to ensure that every person in Mumbai get access to quality preventive health checkup, a critical step for timely response to diseases, TRUTEST Laboratories, a unit of iGenetic Diagnostics is organizing a mega camp from February 23 to 25 across Mumbai. The camp, being organized to mark the 5th anniversary of the diagnostic major, brings unprecedented opportunity for all sections of people of Mumbai to undergo a holistic health check up consisting of 55 key tests at an unforeseeable price of Rs 500 only, nearly six -time lesser than the original price of  tests.  The tests include Complete Blood Count, Glucose Fasting, TSH, Lipid Profile, Liver Profile, Kidney Profile, ESR, and Calcium and so on. Furthermore, they are offering 20% discount on individual test and health packages, making it a win-win situation for the ones visiting the camp. “We at iGenetic have always looks after for encouraging prevention and have striven to bring in the best quality diagnostics solutions in most affordable way so that every section of society can get benefitted. As we are completing the 5 years of our remarkable journey, iGenetic has decided to celebrate this milestone than to take the benefits of preventive checkups to everyone of our society,” said by Ms Arunima Patel, MD, iGenetic Diagnostics. ]]> https://biospectrumindia.com/news/97/12894/lucid-diagnostics-mapmygenome-partner-for-cancer-screening.html https://biospectrumindia.com/news/97/12894/lucid-diagnostics-mapmygenome-partner-for-cancer-screening.html Fri, 22 Feb 2019 09:00:00 +0530 Lucid Diagnostics, a premier diagnostics company and Mapmygenome, a molecular diagnostics company have announced their alliance to advance cutting-edge, personalized and preventive medicine by combining genomics and pathology lab services. Lucid will offer DNA Onco Screen to customers and physicians for prevention and early detection of cancers. “Genetics is an important part of clinical diagnostics and we are pleased to offer these packages with Mapmygenome,” said Dr Sunitha Lingareddy, Managing Director, Lucid Diagnostics. “We are quite excited about this partnership,” said Anu Acharya, CEO, Mapmygenome. “Combining clinical parameters with genomics makes it very compelling for physicians and consumers to get a comprehensive screen.” DNA Onco Screen assesses genetic predisposition to various cancers, physiological traits known to trigger cancer, and lifestyle traits linked to cancer risk. Key clinical markers associated with cancer are also tested. Also offered are advanced packages for men and women, with a complete assessment by the doctor. All packages include genetic counselling to help understand individuals’ risk of cancer, inheritance patterns, and lifestyle changes essential to prevent cancer. These packages are the most effective, efficient, and comprehensive cancer screening tests available in the country. Lucid provides a comprehensive suite of healthcare services and health check-up packages to aid accurate as well as timely diagnosis. Lucid Lab has been accredited with both NABL and CAP to achieve highest standards of excellence and positively impact patient care. Lucid has been awarded Best Diagnostics in the year 2018 by both Times Healthcare and Pharma Leaders at both State and National level. Now Lucid is striving to become a Centre of Excellence in Advanced Imaging as well as research by collaborating with institutes like LVP; Companies like Aizant, Admirus, Juventa, Sristek, and Indian Immunologicals Ltd. Currently, we are running 69 Centers in the states of Telangana, Andhra Pradesh, Karnataka and shortly expanding to have Pan India as well as International presence. Mapmygenome is a molecular diagnostics company that enables people to be proactive about their health. They offer personalized health solutions based on genetic tests that help people get to know themselves. By combining genetic health profiles, health history, and genetic counseling, Mapmygenome provides actionable steps for healthier lives. Services offered include personal genomics, clinical sequencing, Indian genome databases, infectious disease kits and services, research services, and genetic counselling. Founded in 2013, Mapmygenome started as India’s pioneering Personal Genomics Company with a vision to “Touch 100 million lives and save a million lives by 2030.”   ]]> https://biospectrumindia.com/news/97/12890/quest-diagnostics-teams-up-with-houston-healthcare-for-enhancement-of-diagnostic-services.html https://biospectrumindia.com/news/97/12890/quest-diagnostics-teams-up-with-houston-healthcare-for-enhancement-of-diagnostic-services.html Thu, 21 Feb 2019 12:45:00 +0530 Quest Diagnostics, the world's leading provider of diagnostic information services, and Houston Healthcare are teaming up to enhance the quality and value of diagnostic services to patients and their doctors through a new partnership agreement under which Quest will provide full laboratory management services for Houston Medical Center and Perry Hospital.  "We are pleased to partner with Houston Healthcare, a premier healthcare system in central Georgia," said Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics. "In today's pressurized health care environment, health systems like Houston Healthcare are turning to Quest for help executing in their lab strategy. Each relationship begins and ends with how can we help, so they can focus on what they do best, providing quality care to their patients." Under the agreement Quest will provide management expertise, laboratory equipment, supplies and procurement processes for both hospitals, in addition to providing reference testing for both hospitals. "We are pleased to partner with Quest Diagnostics to benefit from their innovative technologies, scale, and commitment to quality," said Charles Briscoe, Chief Operating Officer and Acting CEO of Houston Healthcare. "With the ongoing challenges and opportunities in healthcare, this new relationship allows us to remain focused on improving patient care and outcomes, while teaming up with a leader in the field who has access to the most sophisticated diagnostic equipment available."   ]]> https://biospectrumindia.com/news/97/12889/labcorp-expands-therapeutic-drug-monitoring-portfolio-for-precision-medicine.html https://biospectrumindia.com/news/97/12889/labcorp-expands-therapeutic-drug-monitoring-portfolio-for-precision-medicine.html Thu, 21 Feb 2019 12:25:00 +0530 LabCorp®, a leading global life sciences company that is deeply integrated in guiding patient care, announced a new assay in its therapeutic drug monitoring (TDM) DoseASSURE™ portfolio. The new Certolizumab Concentration and Anti-Certolizumab Antibody DoseASSURE CTZ assay, helps physicians monitor individual drug response for patients who are on Certolizumab, a biologic drug used to treat certain inflammatory diseases, such as rheumatoid arthritis and Crohn’s disease. Biologic drugs are complex, protein-based therapies that can be used to treat certain inflammatory diseases and are among the fastest growing class of drugs available today. However, the expense of these medications and the variability in patient response can present numerous challenges. LabCorp’s DoseASSURE portfolio helps address these challenges by providing quantitative, patient-specific measurement which can guide patient therapy. With the launch of the DoseASSURE CTZ, LabCorp now has the most comprehensive biologics TDM menu in the industry, targeting the largest number of biologic drugs. “Biologic drugs can be life-changing, but individual patient response to biologics can vary greatly,” said David P. King, LabCorp’s chairman and CEO. “LabCorp’s DoseASSURE portfolio helps to deliver on the promise of precision medicine by enabling more effective and more individualized treatment plans that can improve clinical outcomes at reduced costs.” Studies demonstrate the use of TDM can improve efficacy and prolong successful response to biologic treatment. Accordingly, appropriate use of TDM can diminish the need for disease-related surgery and hospitalization by reducing the risk of treatment failure. ]]> https://biospectrumindia.com/news/97/12888/polymed-wins-india-devices-company-of-the-year-award.html https://biospectrumindia.com/news/97/12888/polymed-wins-india-devices-company-of-the-year-award.html Thu, 21 Feb 2019 11:55:00 +0530 Poly Medicure Limited (Polymed), a leading Indian Medical device company, received prestigious ‘India Medical Devices Company of the Year'. The Awards were conferred by Department of Pharmaceuticals, Government of India during the 4th International Conference on Pharmaceutical & Medical Device sector here today. ‘Company of the Year’ Award was received by the Managing Director of Polymed Mr Himanshu Baid from the Union Minister for Chemicals & Fertilizers and Statistics & Programme Implementation, Shri DV Sadananda Gowda. Every year, the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals and Fertilizers presents the awards to the companies for their excellent contribution to the sector. Polymed, the Rs 500+ crore company, earns 70 per cent of its revenue from exports to over 100 countries. As a manufacturer of medical devices and disposables, the company produces more than 125 different types of products. The product range includes infusion therapy, central venous catheter, blood management system, surgery and wound drainage, anaesthesia, urology, gastroenterology and dialysis. The awards, which included categories like India Pharma Leadership, India Pharma Innovation of the year, and Indian Pharma Corporate Social Responsibility of the Year Award, underscoredvaluable contributions of Indian Pharma and Medical Device sector to the nation. ]]> https://biospectrumindia.com/news/97/12878/shimmer-launches-verisense-wearable-sensor-platform-for-clinical-trials.html https://biospectrumindia.com/news/97/12878/shimmer-launches-verisense-wearable-sensor-platform-for-clinical-trials.html Thu, 21 Feb 2019 09:00:00 +0530 Shimmer, a global leader in wearable technology for research applications, has announced the launch of Verisense, its next-generation wearable sensor platform designed from the ground up to meet the needs of clinical trial sponsors, sites and participants. This new technology will be unveiled at the SCOPE Summit for Clinical Ops Executives.  “There is a growing demand from pharmaceutical companies, regulators and payers to factor real-world data (RWD) into healthcare decision making. They want to ensure that new therapies, especially those for chronic conditions, deliver objective improvements to participants’ health and quality of life. That requires access to real-world participant data and has spurred the rapid growth in wearable technologies to measure objective quality of life indicators, such as activity levels and sleep patterns,” said Geoff Gill, president of Shimmer Americas.       The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, stated on Dec. 6, 2018 that leveraging RWD to improve regulatory decisions is a key strategic priority for the FDA. He also unveiled the FDA’s new strategic framework to advance use of real-world evidence (RWE) to support development of drugs and biologics. “RWD and RWE can be especially useful for postmarket monitoring of the safety of products during their use in real world settings,” said Dr. Gottlieb. He added that FDA has “new drug applications under review [in the oncology setting] where RWD and RWE are helping to inform our ongoing evaluation as one component of the total complement of information that we’re evaluating.” “But an effective clinical trial solution has to meet very specific requirements, such as providing access to raw participant data and purpose-built management tools, while placing the minimum burden on sponsors, sites and participants. This can’t be done by simply repurposing consumer wearable devices or other current devices. We started by systematically understanding the needs of sponsors, sites, and participants, then designed Verisense from the ground up to meet those needs,” added Mr. Gill. “The initial feedback from customers has been overwhelmingly positive. Starting in March, customers are planning to use Verisense in trials for Alzheimer’s disease, Parkinson’s disease, cancer-related fatigue, and stroke.”  Verisense is a comprehensive and flexible solution for reliably capturing accurate and complete biometric data. Verisense is launching with the Verisense IMU sensor, a general-purpose Inertial Measurement Unit (IMU). Worn on the wrist, it can monitor activity and sleep seamlessly. In addition, it can be used for any IMU application with up to seven sensors worn on different parts of a participant’s body, making it invaluable for studying complex musculoskeletal or neurological conditions, such as dystonia or epilepsy. Furthermore, researchers can draw on a wealth of published data and established metrics from more than a decade of research using Shimmer devices.  The Verisense platform provides complete clinical trial sponsor support. Sponsors gain access to all the raw participant data; they are uploaded to a secure site and can be transferred to an electronic data capture system automatically to ensure data integrity. Built-in algorithms provide validated metrics. A monitoring dashboard shows the status of all the sites at a glance, and provides the ability to drill down to every sensor in the study. From the site perspective, Verisense requires just a five-minute setup to initiate data collection and participant follow up if the system alerts them to a critical issue.  The Verisense platform places the minimum burden on participants. After putting the base station near their bed, or in another location that they visit every day, all they need to do is wear the sensor. It can even be worn in the shower or bath. The Verisense battery lasts for up to six months and the data transfer is completely automatic. The Verisense sensor can be inserted into a wide variety of cradles, ensuring that it meets all style and functional requirements. ]]> https://biospectrumindia.com/news/97/12883/transasia-installs-diagnostic-instrument-at-mpmmcc-varanasi.html https://biospectrumindia.com/news/97/12883/transasia-installs-diagnostic-instrument-at-mpmmcc-varanasi.html Thu, 21 Feb 2019 09:00:00 +0530 Prime Minister Narendra Modi recently formally inaugurated the Mahamana Pandit Madanmohan Malaviya Cancer centre (MPMMCC) at Varanasi. The hospital has been set up to cater to the population of Uttar Pradesh and Bihar. Narendra Modi was taken through a guided tour of MPMMCC, led by Dr. R. A. Badwe, Director- Tata Memorial centre (TMC), Mumbai, Dr. Satyajit Pradhan, Deputy Director- MPMMCC; Dr. Pankaj Chaturvedi, Dy. Director - Cancer Epidemiology, TMC. The biochemistry laboratory was established and started under the guidance of Dr. Sangeeta Desai, Prof. and Head, Pathology- Tata Memorial Hospital (TMH), Dr. Nitin Inamdar, In-charge, Dept of Biochemistry, TMH by Dr. Geeta Rathnakumar, Lab Manager, Dept. of Biochemistry, TMH and Dr. Pratibha Gavel, Asst. Prof. Biochemistry, HBCH and MPMMC. While on his round of the facility, the Prime Minister also visited the biochemistry laboratory and inaugurated XL-1000, Transasia’s, Made in India, Fully Automated, Clinical Chemistry analyzer.   One of the most trusted in the clinical chemistry segment, XL-1000 is designed for high workload. With a capacity to conduct 1000 biochemical tests / hr, it is most suited for specialized institutes that have a requirement for testing of large number of samples. Infact, it is the first of its kind in Uttar Pradesh. XL-1000 is a result of Transasia’s in-house R&D efforts and indigenous manufacturing capabilities. With close to 200 installations across the globe and exported to more than 100 countries, it is considered the best in its category for the convenience it offers: quality, speed, accuracy and affordability.       The MPMMCC under the aegis of the reputed Tata Memorial Centre, Mumbai has been built at a cost of Rs. 580 crores. Situated within the BHU campus, this 350- bedded ‘patient centric care’ facility, is expected to cater to the healthcare needs of about 40 lakhs patients from the city and nearby areas. The full fledged biochemistry laboratory at the hospital has been set up with joint efforts of Dr. Geeta Rathnakumar and Dr. Pratibha Gavel.    Reacting on the need to set-up a cancer institute in Varanasi, Dr. Satyajit Pradhan said, “Over the years, there has and continues to be an incremental rise in the incidence of cancer in Uttar Pradesh and Bihar. Infact, Varanasi is one of the hot zones, with a growing number of patients suffering from cancers of gall bladder, kidney, head and neck among others. Studies have revealed that the untreated wastes and domestic sewage that is let out in the Ganges, most likely contain environmental pollutants that are acting as carcinogens. Besides this people from the neighbouring villages and towns are addicted to tobacco and gutka, further leading to them succumbing to this deadly disease.” He further added, “Interestingly the process for patient registration started even before the inauguration of the centre. In addition to the localities we are also expecting a lot of people belonging to the low socio-economic background from remote locations far and wide. While choosing the medical equipment for our facility, our main criteria was to select a company who could help us offer an analyzer of international quality standards, providing results in the most cost effective and timely manner. Being a Make in India product, we found Transasia’s XL-1000 along with environmentally friendly, economical consumables, to be the best suited for our centre. To add to that, its wide range of parameters that help in early and accurate diagnosis of cancer, its technical specifications, speed of reporting were all the criteria that we were looking for in an analyzer. We are most satisfied with Transasia’s long-standing repute of providing the best after-sales and technical service support.” Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals said, “We are feeling a sense of great pride that our Make in India product XL-1000 has been inaugurated at  MPMMCC, the second biggest cancer institute in India, through the hands of the visionary of Make in India campaign. This cancer institute is a great initiative and I am sure it will be a big contributor to the Ayushman Bharat Scheme. XL-1000 is a fully automated analyzer with no manual intervention right from blood collection to report issuance, thereby ensuring accuracy and speed of reporting. A lot of patients, who will be coming to  MPMMCC from remote locations, can now go back with the results on the same day itself. Importantly, it offers a complete testing profile for the Heart, Liver and Renal Function Tests that are critical to early cancer diagnosis and evaluating the disease progression. Moreover, being locally manufactured equipment, we are able to ensure that we can offer cost-effective treatment to the patients, and contribute to the Ayushman Bharat Scheme.” He further went on to say, “In the recently announced interim budget, the Government expressed its intent to set-up a National Artificial Intelligence portal to highlight the increasing role of technology in healthcare. XL-1000 infact offers integrated AI sensors and remote diagnosis technology that reduce the downtime and ensure uninterrupted service. Our dedicated team of six sales and service personnel in Varanasi is committed to offering technical and training support at all times.” ]]> https://biospectrumindia.com/news/97/12862/jj-announces-agreement-to-acquire-auris-health.html https://biospectrumindia.com/news/97/12862/jj-announces-agreement-to-acquire-auris-health.html Tue, 19 Feb 2019 12:30:00 +0530 Johnson & Johnson has announced that Ethicon, Inc., entered into a definitive agreement to acquire Auris Health, Inc. for approximately $3.4 billion in cash.  Auris Health is a privately held developer of robotic technologies, initially focused in lung cancer, with an FDA-cleared platform currently used in bronchoscopic diagnostic and therapeutic procedures. Additional contingent payments of up to $2.35 billion, in the aggregate, may be payable upon reaching certain predetermined milestones. This acquisition will accelerate Johnson & Johnson’s entry into robotics with potential for growth and expansion into other interventional applications. Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson said, “In this new era of health care, we’re aiming to simplify surgery, drive efficiency, reduce complications and improve outcomes for patients, ultimately making surgery safer. We believe the combination of best-in-class robotics, advanced instrumentation and unparalleled end-to-end connectivity will make a meaningful difference in patient outcomes.” With this acquisition, Frederic Moll, CEO and Founder of Auris Health and a visionary in the field of surgical robotics, will be joining Johnson & Johnson upon completion of this transaction. “We’re thrilled to be joining Johnson & Johnson to help push the boundaries of what is possible in medical robotics and improve the lives of patients across the globe. Together, we will be able to dramatically accelerate our collective product innovation to develop new interventional solutions that redefine optimal patient outcomes. This combination is a testament to the incredible work of the Auris Health team and the innovation engine behind the Monarch Platform, which represents a huge step forward in endoluminal technology. We look forward to continuing to shape the future of intervention with the added expertise and resources of the world’s largest healthcare organization”, said Dr. Moll “We are very committed to our partnership with Verily on the development of the Verb Surgical Platform. Collectively, these technologies, together with our market-leading medical implants and solutions, create the foundation of a comprehensive digital ecosystem to help support the surgeon and patient before, during and after surgery,” said Ms. McEvoy. The closing is subject to antitrust clearance and other customary closing conditions. The transaction is expected to close by the end of the second quarter of 2019.     ]]> https://biospectrumindia.com/news/97/12849/kiran-medical-systems-ventures-into-color-doppler-segment.html https://biospectrumindia.com/news/97/12849/kiran-medical-systems-ventures-into-color-doppler-segment.html Mon, 18 Feb 2019 15:30:00 +0530 Kiran Medical Systems, the radiology division of Trivitron Healthcare, has ventured into Color Doppler Ultrasound with the launch of Kiran SonoRad V9 Color Doppler in India. SonoRad V9 is a Superior Color Doppler Ultrasound which can be used for wide range of clinical applications. The unique features of SonoRad V9 will further provide maximum value at an affordable cost and is ideal for Nursing Homes, Diagnostic Centres and Large & Mid-Size Hospitals.                                                                                                     Speaking on the occasion, Mr. Satyaki Banerjee, CEO, Kiran Medical Systems, said," The launch of SonoRad V9 Color Doppler Ultrasound is a strategic move and is in line with Kiran’s vision to be a one stop solution in Radiology & Imaging. Kiran brand has always been synonymous with quality and reliability in Radiology and with SonoRad V9, we have an opportunity to make a mark in Sonography segment as well.”   SonoRad V9  comes with strong technical features like 38 cm depth penetration, 4D,  Real Skin Imaging Tomographic Ultrasound Imaging, Panoramic Imaging, Real time Doppler auto-trace, Anatomical M-mode with special 3 cursors,  advanced ergonomics with omni-directional mechanic arm and 19” LED Monitor with 170 degree wide view. It supports wide variety of probes to suit major applications like Obstretics/Gynaecology, Radiology with high performance. SonoRad V9 supports cardiology features like TDI as well and CW/PW/HPRF is available with supporting probe.  SonoRad V9 will be a right choice for multi-dimensional and whole body Color Doppler with high performance to cost ratio.   Mr. M Brahadeesh, President - Imaging, Trivitron said,”Trivitron Healthcare Group has been involved in Ultrasound business for more than 2 decades through strategic partnership with Hitachi-Aloka.  We have an excellent team with rich experience in the modality, strong customer connect & dealer network across the country. Kiran SonoRad V9 will be complimentary to Hitachi's Ultrasound range and will increase our customer penetration in Tier II & Tier III locations as well”   Commenting on this development Dr. GSK Velu, Chairman and Managing Director, Trivitron Group of Companies said, “With the Launch of Kiran’s Sonorad V9 Color Doppler, we are one more step closer towards achieving our Vision of making Healthcare affordable and and accessible to everyone. Kiran will continue to be the flag bearer from India for innovation & quality in Radiology & Imaging Modality”.   Kiran’s portfolio of radiology products includes the Ultisys range of Mobile & Fixed Radiography systems with the option of digital image acquisition chain, Infinity and Elite series surgical C-Arm systems available in 3.5 kW and 5.0 kW generator power options, a comprehensive range of Radiation Protection Products, Anti-scatter X-ray grids and a wide range of Imaging Accessories. ]]> https://biospectrumindia.com/news/97/12850/kiran-medical-systems-ventures-into-color-doppler-segment.html https://biospectrumindia.com/news/97/12850/kiran-medical-systems-ventures-into-color-doppler-segment.html Mon, 18 Feb 2019 15:30:00 +0530 Kiran Medical Systems, the radiology division of Trivitron Healthcare, has ventured into Color Doppler Ultrasound with the launch of Kiran SonoRad V9 Color Doppler in India. SonoRad V9 is a Superior Color Doppler Ultrasound which can be used for wide range of clinical applications. The unique features of SonoRad V9 will further provide maximum value at an affordable cost and is ideal for Nursing Homes, Diagnostic Centres and Large & Mid-Size Hospitals.      Speaking on the occasion, Mr. Satyaki Banerjee, CEO, Kiran Medical Systems, said," The launch of SonoRad V9 Color Doppler Ultrasound is a strategic move and is in line with Kiran’s vision to be a one stop solution in Radiology & Imaging. Kiran brand has always been synonymous with quality and reliability in Radiology and with SonoRad V9, we have an opportunity to make a mark in Sonography segment as well.” SonoRad V9  comes with strong technical features like 38 cm depth penetration, 4D,  Real Skin Imaging Tomographic Ultrasound Imaging, Panoramic Imaging, Real time Doppler auto-trace, Anatomical M-mode with special 3 cursors,  advanced ergonomics with omni-directional mechanic arm and 19” LED Monitor with 170 degree wide view. It supports wide variety of probes to suit major applications like Obstretics/Gynaecology, Radiology with high performance. SonoRad V9 supports cardiology features like TDI as well and CW/PW/HPRF is available with supporting probe.  SonoRad V9 will be a right choice for multi-dimensional and whole body Color Doppler with high performance to cost ratio.  M Brahadeesh, President - Imaging, Trivitron said,”Trivitron Healthcare Group has been involved in Ultrasound business for more than 2 decades through strategic partnership with Hitachi-Aloka.  We have an excellent team with rich experience in the modality, strong customer connect & dealer network across the country. Kiran SonoRad V9 will be complimentary to Hitachi's Ultrasound range and will increase our customer penetration in Tier II & Tier III locations as well” Commenting on this development Dr. GSK Velu, Chairman and Managing Director, Trivitron Group of Companies said, “With the Launch of Kiran’s Sonorad V9 Color Doppler, we are one more step closer towards achieving our Vision of making Healthcare affordable and and accessible to everyone. Kiran will continue to be the flag bearer from India for innovation & quality in Radiology & Imaging Modality”. Kiran’s portfolio of radiology products includes the Ultisys range of Mobile & Fixed Radiography systems with the option of digital image acquisition chain, Infinity and Elite series surgical C-Arm systems available in 3.5 kW and 5.0 kW generator power options, a comprehensive range of Radiation Protection Products, Anti-scatter X-ray grids and a wide range of Imaging Accessories. ]]> https://biospectrumindia.com/news/97/12847/make-in-india-for-clinical-research-needed-iscr.html https://biospectrumindia.com/news/97/12847/make-in-india-for-clinical-research-needed-iscr.html Mon, 18 Feb 2019 13:00:00 +0530 12th Annual ISCR Conference was recently held in Delhi. The theme of the conference was Clinical Research Advancing the Frontiers of Health. The Conference, being attended by 500+ clinical research professionals, focused on various clinical trial reforms that will build the future research enterprise as well as on emerging research opportunities in India. Dr Chirag Trivedi, President, Indian Society for Clinical Research (ISCR) said, ”The changing profile of diseases affecting the Indian population, the continuing high prevalence of endemic diseases and the emergence of lifestyle diseases all point to an urgent need for greater investment in research and innovation to address India‘s increasing disease burden and the incremental costs associated with it. Stakeholders need to work together to build and strengthen the clinical research ecosystem in the country and create an environment that encourages more research. At the same time, there is a need for more education and awareness about clinical research and its benefits not just to participating patients, but also to society at large.” Recent data indicates that the number of clinical trials being done in India as a percentage of global trials continues to fall. From 1.5% a couple of years ago, the percentage of clinical trials in India is now 1.2% which is inadequate for a country that has the second highest population and the highest disease burden in the world. Dr Sanjay Mittal, Senior Director – Clinical Cardiology & Head of Research, Medanta – The Medicity said, “Clinical research in India is governed by robust local and global regulations which makes India amongst the most stringent clinical research regulatory environments in the world. In such an environment we need to encourage, not deter, not-for-profit organisations, institutions and biopharma companies from doing more research in India. The most impacted by the current environment are patients who will not have access to the latest and most effective treatment for various medical conditions. For us investigators too, participating in clinical research exposes us to the latest trends and treatment protocols which, in turn, benefits our practice and patients.” A clinical trial patient at the media briefing shared his experience of participating in a clinical trial and the rigour of the process, while highlighting how the trial benefited his condition. Through two days of panel discussions, the ISCR Annual Conference examined and discussed varied perspectives about clinical research from patients, investigators, regulators and academia. Emerging trends in clinical research, as also career opportunities in clinical research will be discussed during the panels. Parallel to the main track, a separate track focused on Data Management, Medical Writing and Biostatistics is being held. Dr Trivedi said that it was imperative that more is done to highlight the robust regulatory environment in India to stakeholders across the world so as to encourage more investment in clinical research in India. A conducive clinical research ecosystem will encourage more research and development and will give an impetus to the Government of India’s ‘Make in India’ initiative. "We are as committed to the DCGI’s commitment to making safe, efficacious, affordable and quality medicinal products for our people. If we can have a Make in India for other goods and services, why cannot we have a Make in India for clinical research too?” concluded Dr Trivedi. The choice of a country for clinical trials is based on a number of factors including the epidemiology and disease prevalence; access to qualified and GCP-trained investigators; the availability of good infrastructure as well as the future commercial plans for the new medicine. The choice of patients in a study is based on the inclusion-exclusion criteria in the protocol which determines which patients are eligible to participate in a study based on their disease profile and health indicators. In the larger context of India’s unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, more clinical research is needed to develop new and effective medicines and vaccines to tackle the country’s mammoth disease burden and unmet medical needs. India has 18% of the world’s population and 20% of the global disease burden and yet, 1.2% of global trials take place in India.      ]]> https://biospectrumindia.com/news/97/12827/erba-group-showcases-latest-technologies-at-medlab-2019.html https://biospectrumindia.com/news/97/12827/erba-group-showcases-latest-technologies-at-medlab-2019.html Thu, 14 Feb 2019 13:10:00 +0530 At the recently concluded MEDLAB expo, the ERBA Group, a leading global In-vitro Diagnostic Company, launched their latest hematology analyzers, H 360 and H 560. Designed for improving lab efficiency, these systems are paving the way for better healthcare outcomes in over 100 emerging market countries. These latest additions are targeted at small to medium laboratories and complement the larger automatic Elite 580 hematology analyzer launched at MEDLAB 2018. The newly launched, H 360 3-part differential analyzer can run up to 60 samples/hr and requires only 9 microlitres of blood. The H 560 5-part differential analyzer also runs 60 samples/hr and requires only 15 microlitres, which is highly beneficial in pediatric cases. In both systems, interpretation of results is aided using an advanced 3D scattergram. ERBA also displayed the latest version of its powerful Laura XL platform, which is a fully automated urine chemistry and sediment analyzer. Using digital microscopy and AI technology, it auto-recognizes 16 urine sediment elements. Moreover, the photometric urine strip reader aids in precise determination of 10 analytes using ERBA’s standardized test strips DekaPHAN®.  The ERBA group also hosted an education session by Dr. Mir Majid Mossalaeie, Vice President of Iranian Association of Clinical Laboratory Doctors on the effectiveness of AMH ELISA test kits, which helps childless couples conceive though better estimation of ovarian age.  Dr. Mossalaeie commented on the high quality of ERBA’s AMH kit which is made by its US subsidiary, Calbiotech Inc., along with 200 other immunoassay products. Further, the ERBA team of experts provided first-hand experience to the delegates on the new systems with more than 10 demonstrations being conducted each day! The Director-General of Dubai Health Authority, His Excellency Humaid Al Quatami, visited the booth and was highly impressed by the wide range of technologies being offered by the group. During the exhibition, customer interactions were complemented by a series of informational presentations conducted by industry experts and ERBA team members. Insightful discussions on the benefits of fast reporting for better treatment outcomes, validation methods for clinical chemistry systems, and the advantages of AMH ELISA testing were held in addition to presentations on Laura XL, H 360 and 560 and Calbiotech’s high quality ELISA test range. Speaking about ERBA’s participation, Nikhil Vazirani, CEO, ERBA Group, said, “We are glad to be associated with MEDLAB as it offers an opportunity to interact with customers from across the world. ERBA operates in a dynamic global economy and MEDLAB gives us a great opportunity to help understand changing customer needs and how we should adapt our technologies to offer seamless services. We are committed to focusing our products and solutions on the emerging markets and impacting a billion lives globally.” An annual event, MEDLAB has been successfully operating in the MENA region for over 17 years. Home to hundreds of medical laboratory manufacturers from across 46 countries worldwide, it attracts decision makers at all levels of development, manufacture or marketing of medical devices. Held between 4-7 February 2019 at Dubai World Trade Centre, the event attracted more than 25,000 visitors from 130 countries! ]]> https://biospectrumindia.com/news/97/12814/mohfw-highlights-guidelines-regarding-re-use-of-medical-devices.html https://biospectrumindia.com/news/97/12814/mohfw-highlights-guidelines-regarding-re-use-of-medical-devices.html Wed, 13 Feb 2019 10:50:00 +0530 According to a recent announcement by the Minister of State (Health and Family Welfare), Ashwini Kumar Choubey, the Government of India has enacted the Clinical Establishments (Registration and Regulation) Act, 2010 and notified Clinical Establishments (Central Government) Rules, 2012 for registration of Clinical Establishments with a view to prescribing the Minimum Standards of facilities and services provided by them. Under the said Act, the National Council for clinical establishments has approved Minimum Standards for different levels of Hospitals. These minimum standards inter-alia provide that the hospitals should have adequate drugs, medical devices and consumables commensurate to the scope of services and number of beds. These standards further provide that the quality of drugs, medical devices and consumables shall be ensured. The Hospitals are also required to follow standard precautions like practicing hand hygiene, use of personal infection equipment etc. and infection control practices including compliance to Bio-Medical Waste Management Rules to reduce high risk of healthcare associated infection.  Currently, the Act has been adopted by 11 States namely, Sikkim, Mizoram, Arunachal Pradesh, Himachal Pradesh, U.P, Bihar, Jharkhand, Rajasthan, Uttarakhand, Assam and Haryana and all Union Territories except Delhi. The implementation and enforcement of the said Act fall within the ambit of the States/Union territories. As per Constitutional provisions, ‘Health’ is a State subject and such issues would generally be addressed to the State/Union Territory concerned for taking appropriate action as per the provisions of Act and Rules applicable in the concerned State/UT. Data regarding the complaints received by States and action taken by the State to reimburse the affected patients is not maintained centrally. Further, Central Government has published Medical Devices Rules 2017 effective from 01.01.2018. As per the said rules, Medical Device intended to be used for single use should be labeled appropriately. ]]> https://biospectrumindia.com/news/97/12800/mapmygenome-total-brain-to-offer-trial-usage-of-brain-optimisation-platform-to-all-its-users.html https://biospectrumindia.com/news/97/12800/mapmygenome-total-brain-to-offer-trial-usage-of-brain-optimisation-platform-to-all-its-users.html Tue, 12 Feb 2019 11:20:00 +0530 Total Brain, the world’s first holistic brain optimisation platform has announced that it is partnering with Mapmygenome, a molecular diagnostics company, to offer 3-month trials of its digital service to all Mapmygenome users. Mapmygenome’s product Genomepatri assesses inherited and acquired genomic health risks for 100+ conditions. The results provide valuable insight into genomic predisposition to several health conditions, traits, lifestyle tendencies, drug efficacy, and more, helping pre-empt disease. The partnership will enable Mapmygenome users to complement their genetic health profile with brain health insights by assessing their 12 brain capacities and screening for risk of mental conditions. Users will also have access to brain training to improve areas of weakness and optimise areas of strength. At the end of the trial period, Mapmygenome users will have the option to continue using the Total Brain service for a monthly fee. Powered by a scientifically validated digital brain assessment and by the largest standardised neuroscientific database in the world, Total Brain helps individuals assess, rank, screen and train their 12 brain capacities, covering the areas of emotion, feeling, cognition and self-control. Mapmygenome offers personalized health solutions based on genetic tests that help people get to know more about themselves. By combining a genetic health profile and health history with genetic counseling, Mapmygenome provides actionable steps for individuals and their physicians towards a healthier life. “We are excited to partner with Total Brain to offer our users deeper insight into their brains, and the opportunity to train their brains for healthier outcomes. Total Brain’s offering is the perfect complement to our Genomepatri report and is very much in line with our focus on preventative healthcare through healthy habits,” Mapmygenome CEO, Anu Acharya said. “Core brain capacities and mental conditions are not objectively measured or monitored, leading to a variety of issues for people at home and at work.” CEO of Total Brain Louis Gagnon said. “We are pleased to offer a free trial of our platform to Mapmygenome users, enabling them to proactively monitor their brain health and train healthy brain habits.” Total Brain is adding to its B2B channel partnerships by engaging B2C channel partners in targeted consumer markets and this agreement represents the second consumer channel partnership for Total Brain. The trial offer will be available to Mapmygenome users beginning in Q1 2019.   ]]> https://biospectrumindia.com/news/97/12783/medical-fair-india-2019-to-attract-industry-experts.html https://biospectrumindia.com/news/97/12783/medical-fair-india-2019-to-attract-industry-experts.html Mon, 11 Feb 2019 09:00:00 +0530 From 21 – 23 February 2019 the Indian health industry elite will meet at the 25th MEDICAL FAIR INDIA at the Pragati Maidon Exhibition Center in New Delhi. In excess of 15,000 trade visitors are expected and more than 600 exhibitors have registered for participation in the leading trade fair and platform for healthcare on the most populous subcontinent.  A new feature this year is rehaindia (powered by REHACARE) with ranges for rehabilitation and nursing care.  Alongside this new area other focal segments on display at MEDICAL FAIR INDIA 2019 include: medical products and devices, laboratory technology and diagnostics, clinic and health centre furniture, and the health IT segments now so on trend the world over as well as mobile health solutions. Forming an integral part of the programme of attractive side events accompanying this event are CLIN LAB INDIA, a conference with exhibition on lab medicine trends conceived of and organised by Scherago (USA) in cooperation with the Messe Düsseldorf Group, and the FTR4H Conference (Future for Health) held for the third time now. The latter addresses all the issues associated with the digital transformation of healthcare. Another highlight among MEDICAL FAIR INDIA’s side events is Voice of Healthcare, a 2-day conference dealing with various cross-sector topics related to the implementation of a modern healthcare system. This meeting is about trends in technology (like improved care thanks to new processes and technologies such as Artificial Intelligence, for example), aspects of international cooperation through joint ventures with manufacturers and institutions or other countries as well as about best practices for start-up companies and company management.   ]]> https://biospectrumindia.com/news/97/12772/molecular-diagnostics-can-help-improve-treatment-outcomes-experts.html https://biospectrumindia.com/news/97/12772/molecular-diagnostics-can-help-improve-treatment-outcomes-experts.html Fri, 08 Feb 2019 12:25:00 +0530 At the 25th Annual National Conference of Indian Society of Critical Care Medicine, CRITICARE 2019, experts voiced the need for introducing advanced molecular diagnostics in patient care to promote early and timely diagnosis. Gaining spotlight on the three-day event, expert scientist Dr. Aparna Kotekar, Head of Molecular Department at iGenetic Diagnostics, brought into focus how molecular testing can help detect over a hundred different pathogens within 8 hours from blood and various other samples including sputum, pus, synovial fluid etc. Conventional diagnostic approaches using microbiology culture has a much longer turnaround time which can range from two to five days and viruses cannot be cultured in most labs.  Molecular testing is much faster and in addition to bacteria and fungi, it can also identify most of the viruses that are prevalent in critical care settings. “In an ICU scenario, a patient is prescribed broad-spectrum antibiotics and drugs to prevent various viral, bacterial or fungal infections. In case of an infection, the patient condition deteriorates rapidly. A two- to five-day delay in identifying the pathogen through culture method is a crucial loss of time. Meanwhile, the patient’s condition is maintained through continuously feeding of broad-spectrum drugs. Also, bacteria are difficult to detect if antibiotic treatment had already started. Virus detection requires special infrastructure which are not offered by conventional labs. Overuse of drugs can develop resistance to drugs. In comparison, molecular testing is a superior diagnostic approach. Sensitivity is as high as 80%, detection rate is 50% compared to 20% in microbiology,viral detection is possible, and antibiotic drug resistance can be tested on the same molecular platform, within the same turnaround time, using the same patient sample," explained Dr. Aparna Kotekar, Head of Molecular Department at iGenetic Diagnostics. The importance of molecular diagnostics was deliberated upon with experts from the medical fraternity including Dr. Subramanian Swaminathan, Senior Consultant for Infectious Diseases, Dr. Subba Reddy, Critical Care Specialist, and Dr. Sachin Jadhav, Senior Consultant Hematologists. The expert panel concluded that molecular diagnostics is an essential tool for improving patient care. “Both patients and the hospital would benefit from molecular diagnostic. Patients can benefit from targeted treatment, better clinical outcomes, lower cost of treatment and length of hospital stay, and prevents antibiotics usage," said Ms Arunima Patel, Founder and MD, iGenetic Diagnostics. Critcare 2019 was held at the Renaissance Mumbai Convention Center Hotel, Mumbai from 1st to 3rd February 2019. The convention showcased the latest innovations in critical care and had a range of scientific workshops.. the event was attended by over 2500 doctors from across the country ]]> https://biospectrumindia.com/news/97/12762/diabetomics-launches-rapid-poc-test-for-preeclampsia-assessment.html https://biospectrumindia.com/news/97/12762/diabetomics-launches-rapid-poc-test-for-preeclampsia-assessment.html Thu, 07 Feb 2019 16:10:00 +0530 Preeclampsia, characterized as a hypertensive disorder, is an undesirable complication in pregnancy and can affect both the mother and the baby. It is a complex disease a: nd affects multiple organs and systems in the pregnant woman. If not detected early or not managed in time, severe preeclampsia can result in maternal and infant mortality. Preeclampsia generally occurs after the 20th week of gestation and can sometimes occur even a couple of weeks after child birth.  In woman with certain high risk conditions, it is known to occur very early on, in the pregnancy.  Preeclampsia is a global burden. Incidence rates vary from as low as 2% in the developed countries to as high as 18% in parts of Africa. In Latin America, preeclampsia is the #1 cause of maternal mortality. Ten million women develop preeclampsia each year around the world. Worldwide about 76,000 pregnant women die each year from preeclampsia and related hypertensive disorders. The number of babies who die from these disorders is thought to be on the order of 500,000 per annum. In developing countries, a woman is seven times as likely to develop preeclampsia than a woman in a developed country. 10-25% of these cases will result in maternal death.  In India, Preeclampsia is reported to be between 8-10% of the 28 Million pregnancies each year.    About 3.5 Million babies are born prematurely in India every year. 45-50% of preterm births are due to unknown causes, 15-20% of these preterm births are due to medically induced or elective pre-term deliveries.  For early detection and timely management of Preeclampsia, antenatal clinics with all facilities capable of dealing with high risk pregnancies, along with trained manpower is an important requirement.    DiabetOmics,  a global medical diagnostic company headquartered in Portland, USA,   understanding the need for early and reliable assessment of preeclampsia,  has launched a new, first-of-its kind, rapid, point-of-care,  test -  Lumella. Lumella provides an accurate and reliable estimate of Glycosylated Fibronectin (GlyFN) - a protein biomarker that is elevated in pregnant women with a high risk for developing Preeclampsia. Lumella is a proprietary test developed by DiabetOmics through extensive research. It uses a simple test strip (similar to home pregnancy test kit) and a hand-held quantitative reader. The test can be done with a finger prick blood sample and can be done in the physician’s clinic. Test results are available in 10 minutes and therefore the assessment can be completed within the same visit of the pregnant woman to consult with her Obstetrician. The test being simple and easy to use,  enables its adoption in any setting – remote,  rural or urban.   The Lumella test system,  has recently received regulatory approval in India,  said Dr Srinivas Nagalla,  Founder & CEO of DiabetOmics Inc.,  On the launch occasion,  Varaprasad Reddy,  Chairman of DiabetOmics,  unveiled their first product,  Lumella test for Preeclampsia.  The first Lumella test systems were handed over  to  (1)  Dr. Ramesh Kancherla,  Chairman & Managing Director of Rainbow Hospitals, Hyderabad,   (2) Dr. Swapna Yendru,  Director of Swapna Healthcare,  Hyderabad,   and (3) Dr. Sridhar,  Managing Director of an Obgyn Hospital in Kakinada.   Dr. Shanthakumari,  Immediate Past Chairperson of Indian College of Obstetricians and Gynaecologists (ICOG) presided over the function and outlined the magnitude of Preeclampsia in India.  Dr. Pratibha,   Retd Professor and HOD of Dept of Obgyn, Osmania Medical College, Hyderabad,  briefed about the situation in a public health setting.  ]]> https://biospectrumindia.com/news/97/12747/bd-launches-bd-nano-second-gen-pen-needle-technology.html https://biospectrumindia.com/news/97/12747/bd-launches-bd-nano-second-gen-pen-needle-technology.html Thu, 07 Feb 2019 13:00:00 +0530 BD (Becton, Dickinson and Company), a leading global medical technology company, announced the U.S. Food and Drug Administration 510(k) clearance of its second generation BD Nano™ pen needle, designed for more reliable subcutaneous injection depth. BD Nano™ 2nd gen pen needles offer people who inject diabetes medications a more reliable subcutaneous delivery of their medication, designed to help people better manage their diabetes.  Proper injection technique is critical to insulin's consistent absorption and there are several factors that can inhibit predictable insulin uptake, including accidental intramuscular injections, which can be caused by greater than required injection force. BD Nano 2nd gen pen needles help mitigate the risks resulting from user injection force variability through its contoured needle base and compensate for variable injection forces by first concentrating, then distributing pressure closely around the injection site (to support more reliable 4 mm target injection depth compared to other 4mm pen needles). The new design has demonstrated more reliable subcutaneous injection depth resulting in up to an 8-fold reduction in calculated intramuscular injection risk. Additionally, the new ergonomic design of BD Nano 2nd gen makes it easier to use, from attachment to disposal, compared to other pen needles, and results in a more comfortable injection experience. This latest advancement to the BD Nano portfolio includes all the benefits its predecessor pen needle has, including BD's 32G x 4 mm pen needle with 5-bevel PentaPoint™ comfort, which has been clinically shown to enter the skin more easily than other 3-bevel needles, providing a smoother and more comfortable injection, and extra thin wall EasyFlow™ technology that increases the medication flow rate, making injections easier. FDA 510(k) clearance will enable BD Nano 2nd gen pen needles to be commercially available in mid-2019.     ]]> https://biospectrumindia.com/news/97/12729/omnivision-develops-innovative-smart-dental-mirror-.html https://biospectrumindia.com/news/97/12729/omnivision-develops-innovative-smart-dental-mirror-.html Tue, 05 Feb 2019 15:25:00 +0530 OmniVision Technologies, Inc., a leading developer of advanced digital imaging solutions, along with SMARTmirror, a developer of innovative dental products, has announced from MD&M West in Anaheim the world's first Wi-Fi-enabled smart dental mirror, which sends images and video in real time to a connected tablet. This uniquely enables dental professionals and patients to see inside the patient's mouth during exams and procedures. The sapphire mirror is similar in size and weight to a standard dental mirror, which is made possible by OmniVision's tiny OVM6946 CameraCubeChip™ wafer-level camera module. Some patients mistrust dentists and fear that they will suggest unnecessary and painful treatments. As a result, dentists face resistance to treatments that they believe are necessary for a patient's health. The SMARTmirror is designed to alleviate these concerns and improve the communication between dentists and patients. Its sapphire mirror provides 12x magnification and won't scratch or fog up like a standard mirror, and the 36 integrated LEDs with adjustable intensity offer brighter illumination when needed. The OVM6946 camera module is built on OmniVision's OmniBSI+™ pixel architecture and can capture 400 x 400 resolution video at 30 frames per second (fps), providing a 120-degree diagonal field of view and a focusing range from 3mm to infinity. The module measures 1.05 x 1.05 x 2.27mm, which makes it small enough to embed seamlessly within the 4mm thick SMARTmirror. The OVM6946 has also been integrated into a number of single-use medical devices for endoscopy, an application where small size is equally important. The SMARTmirror is currently in pilot testing with 200 dentists, and well over 2,000 inspections and procedures have been performed using the device. It is expected to be available in mass production in Q2 2019. ]]> https://biospectrumindia.com/news/97/12727/clinical-research-advancing-health-frontiers-iscr.html https://biospectrumindia.com/news/97/12727/clinical-research-advancing-health-frontiers-iscr.html Tue, 05 Feb 2019 14:30:00 +0530 The Indian Society for Clinical Research (ISCR) with its 12th annual conference aims to bring the clinical research community together to learn, connect, and explore opportunities to drive excellence in clinical research. Based on the theme Clinical Research Advancing the Frontiers of Health, the two-day conference is expected to be attended by over 500 delegates from medical institutions, ethics committees, biopharmaceutical industry, government, patient organizations and clinical research organizations. Prof V. K Paul, Member, NITI Aayog, Government of India, will deliver the Prof Ranjit Roy Chaudhury Oration on the inaugural day. “Over the last few years, a lot has evolved and continues to evolve in the regulatory environment for clinical research in India. The focus of this year’s Conference will be on how we bring all these reforms cohesively together to build the future research enterprise in the country and address research opportunities emerging in the new environment,” said Dr. Chirag Trivedi, President, ISCR. “Given the growing rate of India’s disease burden, it is essential for us to expand clinical research to facilitate emergence of a solution to the existing health challenges of our country.” Currently India has approximately 20% of the world’s disease burden and yet does less than 1.3% of global clinical research. The Conference on February 15th and 16th will feature two parallel tracks focusing on clinical operations and data management/biostatistics/medical writing. Prior to the annual conference, five pre-conference workshops have been scheduled on February 14th on Clinical Trial Disclosure and Data Transparency, Preparation of Scientific Research Publications,  Pharmacovigilance Obligations for MAHs in India, Inspection Readiness and Career Opportunities in Clinical Research. ]]> https://biospectrumindia.com/news/97/12684/core-diagnostics-organises-meet-on-precision-medicine.html https://biospectrumindia.com/news/97/12684/core-diagnostics-organises-meet-on-precision-medicine.html Thu, 31 Jan 2019 16:40:00 +0530 CORE Diagnostics, a healthcare startup and the go-to institution for high-end clinical diagnostics recently organized a healthcare meet on “Precision medicine: Progress and Promise” at The Oberoi, New Delhi. Precision medicine (PM) is an advanced, data-driven approach that helps select the best treatment option, customized for each patient. The event was inaugurated by keynote speaker Jay Flatley who serves as the Executive Chairman of the Board of Directors, Illumina; a global leader in genomic sequencing and array-based technologies for application in the life sciences, oncology, reproductive health and other emerging segments. Flatley commented, “Precision medicine harnesses patient-specific data to create therapeutic options exclusively tailored to individual patients.” Among other diseases, various forms of cancer, when managed with this approach, improve the chance of survival with fewer adverse side effects, reduced exposure to harmful radiations, and increase the overall effectiveness of care. His keynote focused on the evolution of genomics over the past two decades, where the cost of sequencing the whole genome of a person went from over several billion dollars, to less than $1000, with a hundred-dollar target well within the near term horizon. A large-scale population study with an Indian cohort is the much needed next step in understanding disease patterns that are specific to people of Indian origin – such as propensity to diabetes, metabolic disorders, cardiovascular disease, several types of cancer. Flatley described several such large-scale genomics studies across the globe - in the UK, US, China, and underscored the importance of such studies in India. Zoya Brar, Founder & MD, CORE Diagnostics, added, “India has made excellent progress in the past five years in creating awareness about molecular diagnostics and precision medicine. Our aim is to make genomic sequencing accessible to a much broader population base. We are excited about Illumina’s interest in India.” Nearly 75 attendees representing pharma executives, top healthcare leaders, senior physicians participated in the event. The Q&A session with Flatley focused on central issues in the science of genomics, its practical applications in making better therapeutic decisions, as well as affordability. ]]> https://biospectrumindia.com/news/97/12675/accuron-technologies-spins-out-medtech-business.html https://biospectrumindia.com/news/97/12675/accuron-technologies-spins-out-medtech-business.html Thu, 31 Jan 2019 11:10:00 +0530 Accuron Technologies Limited announced that it will spin out its MedTech business. The Accuron MedTech Group (Accuron MedTech), Southeast Asia’s largest medical device business, will be established as a leading vertically integrated urology business.  As a result of the spin-out, Accuron MedTech will be directly owned by Temasek. The move will allow Accuron MedTech’s management team to better focus on global MedTech growth and investment opportunities. It is anticipated that the process will be completed by March 2019.  Philip Yeo, Chairman of Accuron Technologies Limited, said: “Accuron MedTech has been managed as an independent division of Accuron Technologies for some time now. The spin out will enable Accuron MedTech to be more agile in managing its operations, putting it on a stronger platform for sustained growth and technology commercialisation. The move will also allow Accuron Technologies Limited to focus its resources to pursue opportunities in the growing Aerospace and Industrial businesses.”  Over the past 3 years, Accuron MedTech has grown its revenue by more than 30% through the launch of new products such as the Delta III, the first SmartLitho for stone treatment, and more than 10 M&A transactions.   ]]> https://biospectrumindia.com/news/97/12655/zimmer-biomet-receives-fda-clearance-for-rosa.html https://biospectrumindia.com/news/97/12655/zimmer-biomet-receives-fda-clearance-for-rosa.html Tue, 29 Jan 2019 17:00:00 +0530 Zimmer Biomet, a global leader in musculoskeletal healthcare has announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Knee System for robotically-assisted total knee replacement surgeries. Christopher J. Cannova, M.D., Washington Joint Institute at OrthoBethesda said, "Complementing the skill and expertise of the surgeon with ROSA Knee's robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency. ROSA Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion." ROSA Knee leverages Zimmer Biomet's ROSA Robotics platform, which includes ROSA Brain for neurosurgical procedures. Ivan Tornos, Group President, Orthopedics said, "We are excited for the launch of ROSA Knee, which brings together Zimmer Biomet's robotics technology with our industry-leading Knee implants to help surgeons personalize surgical procedures for their patients. Zimmer Biomet is committed to leading the industry in bringing differentiated and holistic solutions to market that address the needs of our customers and improve patient outcomes." ROSA Knee features 3D pre-operative planning tools and real-time, intraoperative data on soft-tissue and bone anatomy designed to improve bone cut accuracy and range of motion gap analysis to potentially improve flexion and restoration of natural joint movement. ]]> https://biospectrumindia.com/news/97/12651/kroger-health-pts-diagnostics-to-spot-and-treat-diabetes-heart-disease.html https://biospectrumindia.com/news/97/12651/kroger-health-pts-diagnostics-to-spot-and-treat-diabetes-heart-disease.html Tue, 29 Jan 2019 13:25:00 +0530 PTS Diagnostics and Kroger Health, The Kroger Co.'s nationwide arm of health and wellness facilities, services and programs, announced today the full rollout of CardioChek Plus analyzers for point-of-care blood testing to help identify individuals at-risk of heart attack, stroke and diabetes. CardioChek Plus analyzers provide accurate, on-site results in as little as 90 seconds using the same technology as clinical laboratories.  Its speed and portability combined with the reach and influence of Kroger Health pharmacies and clinics will increase the number of potential patients who are able to receive preventative health screenings and begin clinical protocols. The CardioChek Plus system accurately tests lipid profile and glucose simultaneously with one fingerstick, eliminating the need for additional testing or machinery, and enabling a more seamless process for the customer. It is one of the fastest, most cost-efficient, and user-friendly analyzers in the world. The system measures total cholesterol, HDL cholesterol, triglycerides and glucose, and provides real-time readings and ratios that are immediately documented by trained associates onsite. Because of its handheld, portable design, the CardioCheck Plus analyzers are easy to transport, store and operate. Implementing the switch to The CardioChek Plus in all Kroger Health locations is another meaningful move towards eliminating preventable disease through early identification, targeting disease progression. Additionally, the speed and portability of The CardioChek Plus combined with the reach and influence of Kroger Health pharmacies and clinics increases the number of patients able to receive preventive screenings and begin clinical protocols. Kroger Health includes more than 22,000 healthcare associates across over 2,100 pharmacies and clinics. Their trained professionals provide services, treatment and coaching in multiple areas, from nutrition counseling and weight loss programs, to diabetes prevention and immunization services. The CardioChek Plus rollout coincides with Kroger Health's broader health and wellness initiatives, including the "Wellness Your Way" campaign, designed to provide personalized solutions for healthcare to the more than 60 million Americans who visit the Kroger family of companies – including Kroger, Ralph's, Fry's, and Fred Meyer - each year.    The CardioChek Plus is FDA – cleared, CLIA – waived and meets National Cholesterol Education Program (NCEP) guidelines for accuracy and precision. The final rollout of analyzers will be complete by February 2019. ]]> https://biospectrumindia.com/news/97/12644/medicure-invests-10m-sensible-medical-to-market-reds.html https://biospectrumindia.com/news/97/12644/medicure-invests-10m-sensible-medical-to-market-reds.html Tue, 29 Jan 2019 10:40:00 +0530 Medicure Inc., a cardiovascular pharmaceutical company, is pleased to announce it has entered into an agreement with Sensible Medical Innovations Inc. (Sensible) to become the exclusive marketing partner for the ReDS™ point of care system (ReDS) in the United States. ReDS is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. The lung fluid measurements are used in guiding treatment and monitoring a heart failure patient's condition and may lead to a significant decrease in readmissions and hospital costs.  Clinical studies have shown an 87% reduction in heart failure readmission rates for patients using the ReDS system at home for three months post-discharge versus those who were treated with usual care alone. ReDS is already marketed to U.S. hospitals by Sensible and Medicure expects to begin marketing ReDS immediately using its existing commercial organization.  Under the terms of the agreement, Medicure will receive a percentage of total U.S. sales revenue of the device and must meet minimum annual sales quotas.   In addition, Medicure has invested US$10.0 million in Sensible for a 7.71% equity stake on a fully diluted basis. In connection with the investment, Medicure's President and CEO, Dr. Albert D. Friesen, has been appointed to the Board of Directors of Sensible.     ]]> https://biospectrumindia.com/news/97/12629/trivitron-launches-flat-panel-digital-c-arm-digital-mammography-system-.html https://biospectrumindia.com/news/97/12629/trivitron-launches-flat-panel-digital-c-arm-digital-mammography-system-.html Mon, 28 Jan 2019 15:35:00 +0530 Kiran Medical Systems, the radiology division of Trivitron Healthcare, introduced its innovation driven Elite – Flat Panel Digital C-arm & Felicia – Digital Mammography system during the Arab Health Convention in Dubai.  The Elite Digital C-arm offers a World-Class Surgical Imaging experience for high precision image Guided Procedures. Elite Digital features high resolution digital image acquisition with 1K X 1K Flat Panel Detector and 16 bit image processing.  With World-Class 5 kW, 40 KHz X-Ray Generator with ABS for optimized dose, Elite Digital delivers superior imaging with higher grayscale resolution that makes various anatomical structures visible with greater accuracy. Elite Digital features DSA - Digital Subtraction Angiography that is used in Vascular Procedures and Road Mapping feature that allow surgeons to find the path to reach the target location in branches during the surgery. The Equipment offers extra power for complex cases and active cooling to prevent overheating during long procedures.  With User friendly Workstation and a Storage capacity of more than 100,000 images, Elite Digital offers wide Intra-Operative Imaging Applications.  Felicia – Digital Mammography system is a result of Kiran’s commitment to fight Breast Cancer through the power of advanced technology. Felicia is designed in such a way that the overall mammogram experience is less painful for patients, easier for caregivers and delivering high quality clinical images at low radiation dose. Felicia features an advanced Cesium Iodide scintillator detector with 77 micron pixel pitch that helps in delineating the smallest of calcifications that is pivotal for early detection of breast cancer.  Felicia’s Flex Paddle Technology accommodates the natural contour of the breast and allows image capture with reduced patient discomfort.  The equipment includes an Acquisition Workstation and Review Workstation with dual 5 MP high resolution monitors for Advanced Reports management and precise diagnosis.  Kiran’s portfolio of radiology products includes the Ultisys range of Mobile & Fixed Radiography systems with the option of digital image acquisition chain, Infinity and Elite series surgical C-Arm systems available in 3.5kW and 5.0kW generator power options, a comprehensive range of Radiation Protection Products, Anti-scatter X-ray grids and a wide range of Imaging Accessories.  The manufacturing facilities of Kiran comply with the most stringent quality standards and are registered with US-FDA, SGS-UK, Health Canada and PMDA-Japan amongst others.  Kiran’s ranges of radiology equipment are made cost-effective for the Indian market by adhering to the company’s inherent philosophy of ‘Make in India’. With approximately 50-65% of the entire raw materials / components designed and manufactured from scratch in India, there is a significant cost reduction in the development of the equipment subsequently enabling the brand to make the products available at affordable prices.  With Kiran’s newly launched Flat Panel Digital C-arm & Digital Mammography systems, mid-size hospitals and diagnostic centers could avail such high-end technology enhancing healthcare delivery and reach to the remotest geographies.   ]]> https://biospectrumindia.com/news/97/12624/fda-okays-zimmer-biomets-rosa-knee-system-.html https://biospectrumindia.com/news/97/12624/fda-okays-zimmer-biomets-rosa-knee-system-.html Mon, 28 Jan 2019 12:30:00 +0530 Zimmer Biomet Holdings, Inc. a global leader in musculoskeletal healthcare, has announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Knee System for robotically-assisted total knee replacement surgeries. ROSA Knee features 3D pre-operative planning tools and real-time, intraoperative data on soft-tissue and bone anatomy designed to improve bone cut accuracy and range of motion gap analysis to potentially improve flexion and restoration of natural joint movement. "Complementing the skill and expertise of the surgeon with ROSA Knee's robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency," said Christopher J. Cannova, M.D., Washington Joint Institute at OrthoBethesda. "ROSA Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion." ROSA Knee leverages Zimmer Biomet's ROSA Robotics platform, which includes ROSA Brain for neurosurgical procedures.   ]]> https://biospectrumindia.com/news/97/12621/amtz-signs-mou-with-euro-alliance.html https://biospectrumindia.com/news/97/12621/amtz-signs-mou-with-euro-alliance.html Mon, 28 Jan 2019 11:30:00 +0530 An agreement has been recently signed between Andhra Med Tech Zone and Euro Alliance SA, to drive collaboration between innovation-driven Switzerland and the world’s fastest growing large economy, India. The agreement was signed in the presence of Dr Poonam Malakondiah, Special Chief Secretary of the department of health, Government of Andhra Pradesh as part of the three-day World Economic Forum Summit being held at Davos from January 22 to January 25, 2019. As per the agreement, medical devices manufacturing in Andhra Pradesh will get a major boost and also support manufacturers at AMTZ to reach Swiss market. ]]> https://biospectrumindia.com/news/97/12562/core-diagnostics-launches-nephrocore-targeting-kidney-diseases.html https://biospectrumindia.com/news/97/12562/core-diagnostics-launches-nephrocore-targeting-kidney-diseases.html Tue, 22 Jan 2019 18:20:00 +0530 CORE Diagnostics, a next-generation startup and go-to-expert for high-end clinical diagnostics, well known for it’s oncology (cancer-related) diagnostics, announced the launch of it’s division for advanced diagnostic services in nephrology called “nephroCORE”. These services will ensure best clinical intervention to improve outcomes in several chronic and generic kidney diseases including kidney transplants.   CORE’s new addition of nephrology related diagnostic tests comprises of advanced nephro-pathology services, molecular testing for rare and inherited (genetic) kidney diseases, screening for pre and post-transplant infectious diseases, monitoring drug levels, and Transplant Immunology. Very few laboratories in India provide such services and expertise.  On the occasion of the launch, Zoya Brar, Founder & MD, CORE Diagnostics said “We want to bring back the focus on the unmet need to diagnose and treat kidney disease earlier in order to slow the progression of the disease. Unsuccessful or inadequate clinical intervention can impose a heavy financial burden on patients. Kidney disease is considered a silent disease; most cases are diagnosed in later stages. We are confident that with the newest addition of nephrology diagnostic services, we will improve the healthcare outcomes and quality of lives of the patients we serve.” Within a span of one month, CORE has already reported over 200 cases of native and transplant kidney biopsies from across India and a few international territories. “Kidney biopsies are the gold-standard for the diagnosis of medical and transplant kidney disorders. At CORE, we run the rarest of high-end diagnostic markers on renal biopsy samples that help us come up with a definitive diagnosis along with prognostic information for the treating physician,” commented Dr. Rajan Duggal, Vice President nephro CORE.  Dr. Duggal has around ten years of experience in renal pathology. Prior to working at CORE, he was at PGIMER Chandigarh, Medanta Medicity, and Fortis Hospitals and has seen over 10,000 kidney biopsies to date.   ]]> https://biospectrumindia.com/news/97/12556/royal-philips-unveils-advanced-imaging-solutions-in-india.html https://biospectrumindia.com/news/97/12556/royal-philips-unveils-advanced-imaging-solutions-in-india.html Tue, 22 Jan 2019 10:40:00 +0530 Royal Philips, a global leader in health technology, recently unveiled its latest Imaging Systems range with solutions including the Next MR Wave (Ingenia Ambition, Ingenia Elition), Epiq Elite Ultrasound System, DigitalDiagnost C90 ( Digital X-ray), Intellispace Discovery, Compressed SENSE and Philips IQon (CT) at IRIA 2019, the annual conference of Indian Radiological and Imaging Association, in Chandigarh. Designed to connect people, data, and technology, these state-of-the-art innovations offer benefits including improved outcomes, enhanced patient experience, increased staff satisfaction and lowered cost of care delivery. These solutions will equip clinicians with detailed information thereby resulting in diagnosis that is more confident. Bringing much-needed advances to the demanding application areas of imaging systems, Philips’ Ingenia Ambition 1.5T MR is the latest advance in the MRI portfolio. Another innovation of the Ingenia range, Philips Ingenia Elition offers cutting-edge MR imaging techniques, while setting new standards for clinical research in 3.0T imaging based on superior gradient and RF designs. Philips also announced a new and exciting MR clinical application-Compressed SENSE, which is a unique break through acceleration technique speeding up not only sequences but also the entire scan. ]]> https://biospectrumindia.com/news/97/12543/acceptance-of-eifu-for-medical-device-a-welcome-move-mtai.html https://biospectrumindia.com/news/97/12543/acceptance-of-eifu-for-medical-device-a-welcome-move-mtai.html Mon, 21 Jan 2019 11:15:00 +0530 Medical Technology Association of India, which represents leading research-based medical technology companies with significant investments in India has welcomed the Ministry of Health & Family Welfare Gazette notification on acceptance of eIFU (electronic Instructions for Use) for Medical Device and Equipment and said that the regulation is line with governments push for digitalization to reduce the use of Paper. Ministry of Health & Family Welfare on January 15, 2019 published Gazette notification on acceptance of eIFU for Medical Device and Equipment. “The acceptance of eIFUfor  Medical Device and Equipment puts India’s regulatory specifications in line with the practices of some of the advanced countries like Singapore, USA and countries of Europe and will improve users access to more detailed and up-to-date information,” said Mr. Pavan Choudary, Chairman and Director General, MTaI. MTaI further said that the inclusive approach of CDSCO and Health Ministry in considering suggestions encourages the industry. “Many products cannot be supplied with Paper IFU as the product is transferred to the loaner kit in the supply chain and sterilized before being supplied to the doctor, the acceptance of eIFU will remove such issues.” Mr. Pavan Choudary added. MTaI had made several representations to the CDSCO for the acceptance of eIFU for Medical Device and Equipment. About Medical Technology Association of India (MTaI)Medical Technology Association of India (MTaI – pronounced as Em-tai) is a not-for-profit organization duly registered under sub-section (2) of section 7 of the Companies Act, 2013 and Rule 8 of the Companies (Incorporation) Rules, 2014. MTaI is an association of research-based medical technology companies who have made remarkable investments in Manufacturing, R&D and Health Care Workers Training in India. MTaI represents a wide spectrum of the medical device industry with global experience in innovation and manufacturing. All the time stressing on the three hallmarks of healthcare - Quality, Consistency and Patient Safety, MTaI wants to be a responsible voice of the industry. The association is committed to improving access to affordable and quality healthcare for patients. MTaI looks to partner with the Government of India in setting a roadmap for the growth of medical devices sector by bringing in even bigger investments in this sector, through 'Make in India’ and through technology upgradation and dissemination in the provider space.  ]]> https://biospectrumindia.com/news/97/12537/siemens-healthineers-introduces-latest-digital-solutions-at-iria-2019.html https://biospectrumindia.com/news/97/12537/siemens-healthineers-introduces-latest-digital-solutions-at-iria-2019.html Fri, 18 Jan 2019 17:20:00 +0530 ACUSON Sequoia inaugurated by Dr. M.S.Sandhu, Professor and Head – Department of Radio Diagnosis & Imaging, PGIMER   At the 72nd Annual Conference, IRIA, Chandigarh, India, Siemens Healthineers presents a series of new products and latest technology update at the event. Innovation with MRI, X-ray machine and Ultrasound portfolio, Cutting edge technology with CT scanners, and the powerful AI-based system were showcased at the IRIA 2019 exposition, Chandigarh, India. The products, ACUSON Sequoia and MAGNETOM Lumina were also unvieled at the IRIA; by Dr. M.S.Sandhu, Professor and Head – Department of Radio Diagnosis & Imaging, PGIMER, Chandigarh. Magnetom Lumina is the latest addition to the new portfolio of BioMatrix scanners from Siemens Healthineers and features a 70-cm bore. BioMatrix provides our customers with a comprehensive set of innovative MR technologies – technologies that automatically adapt to the patient’s anatomical and physiological characteristics. Biomatrix Technology is the key to making MRI even more consistent and more robust, reducing unwarranted variations in imaging results; and achieving standardized, reproducible results. The new Acuson Sequoia was developed in response to one of the most prevalent challenges in ultrasound imaging today: imaging of different sized patients with consistency and clarity. With its new Deep Abdominal Transducer (DAX) - a new high-powered architecture with innovative updates to elastography and contrast-enhanced ultrasound; the new Acuson Sequoia produces penetration up to 40cm. The BioAcoustic technology of Acuson Sequoia helps to improve the visualization and assessment of lesions. The view time of contrast agents is also significantly longer, allowing clinicians more time to scan for additional incidental lesions during their examinations and with up to twice the sensitivity. Syngo Virtual Cockpit by Siemens Healthineers, is a software solution that can be used for CT and PET/CT scanners, MRI and MRI PET systems. Medical staff can use this software solution to connect remotely to scanner workplaces to assist personnel at a different location, especially where more sophisticated examinations are required. For radiological examinations, experienced colleagues can “tune in” quickly and in real time via audio or video functions, and connect to other locations seamlessly; saving on time and cost. By ensuring best possible support from experts in any location; high quality and uniformed imaging can be achieved across all the locations desired. It would also help in reducing the number of undesired variations in scan quality, which in turn enables to deliver more accurate and precise radiological diagnosis. Siemens Healthineers has a long history of AI-enriched solutions with over 40 deployments embedded in the imaging modalities and syngo.via AV solutions. AI-Rad Companion is a new dedicated software platform that brings artificial intelligence (AI) to medical imaging. The AI-Rad Companion assists radiologist in reading and reporting. It’s first application, AI-Rad Companion Chest CT, automatically performs measurements, prepares results for reports, highlights and characterizes anatomies and abnormalities and in addition to that even creates references with risk scores and reference values. The results may eliminate the step of manual image post-processing on an advanced visualization device and therefore increase the accuracy in interpretation and reporting. “We are focused on how digitalisation is helping empower our customers in their journey towards delivering high-value care. Our products and solutions are addressing some of the core challenges faced by our customers; improving patient experience, managing chronic diseases and optimizing clinical operations.“ said, Vivek Kanade, Executive Director, Siemens Healthineers, India. ]]> https://biospectrumindia.com/news/97/12522/nih-fitbit-launch-byod-project.html https://biospectrumindia.com/news/97/12522/nih-fitbit-launch-byod-project.html Thu, 17 Jan 2019 12:30:00 +0530 Global wearables brand, Fitbit and the National Institutes of Health (NIH) has launched the Fitbit Bring-Your-Own-Device (BYOD) project, the first digital health technology initiative for the All of Us Research Program. Fitbit users currently enrolled in the program can now choose to sync their Fitbit accounts to help researchers unlock deeper insights into the relationships between health indicators such as physical activity, heart rate, sleep and health outcomes. By consenting to sync their data with All of Us, Fitbit users have the opportunity to contribute to one of the world’s largest precision medicine studies and help build one of the most diverse data sets for scientific research. Fitbit is the first wearable to be included in the program. Launched nationally in May 2018, All of Us seeks to enroll one million or more participants, with the goal of improving the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics. Participants will be invited to share different types of health information over time through surveys, electronic health records, physical measurements, biosamples and digital health technologies. Data will be made accessible to researchers for a wide range of health studies, with strict safeguards in place to protect participant privacy. Eric Dishman, director of the All of Us Research Program said, “Collecting real-world, real-time data through digital technologies will become a fundamental part of the program. This information in combination with many other data types will give us an unprecedented ability to better understand the impact of lifestyle and environment on health outcomes and, ultimately, develop better strategies for keeping people healthy in a very precise, individualized way.” As a national leader in research using digital health technologies, Scripps Research is spearheading the program’s digital health effort. In 2017, Scripps Research selected Fitbit as the first wearable for use in the groundbreaking All of Us program, based on the popularity and credibility of its use in peer-validated clinical research. Adam Pellegrini, general manager, Fitbit Health Solutions said, “This is a tremendous opportunity for Fitbit users who choose to participate, to further contribute to one of the world’s largest research efforts by providing information that can help pave the way to a healthier future for all of us. Every day we learn more about the potential for wearable data to inform personalized healthcare and through All of Us, the research community will gain an even better understanding of the role wearable data can play in helping to prevent and treat disease.” A second All of Us research initiative using Fitbit devices will launch in 2019 that involves providing up to 10,000 Fitbit devices to a diverse set of participants randomly invited to take part. The study, which will be conducted by Scripps Research Translational Institute, will generate a unique data set for exploring the relationship between health indicators such as physical activity, heart rate and sleep in conjunction with other critical health outcomes that will be captured as part of All of Us. ]]> https://biospectrumindia.com/news/97/12523/nih-fitbit-launch-byod-project.html https://biospectrumindia.com/news/97/12523/nih-fitbit-launch-byod-project.html Thu, 17 Jan 2019 12:30:00 +0530 Global wearables brand, Fitbit and the National Institutes of Health (NIH) has launched the Fitbit Bring-Your-Own-Device (BYOD) project, the first digital health technology initiative for the All of Us Research Program. Fitbit users currently enrolled in the program can now choose to sync their Fitbit accounts to help researchers unlock deeper insights into the relationships between health indicators such as physical activity, heart rate, sleep and health outcomes. By consenting to sync their data with All of Us, Fitbit users have the opportunity to contribute to one of the world’s largest precision medicine studies and help build one of the most diverse data sets for scientific research. Fitbit is the first wearable to be included in the program. Launched nationally in May 2018, All of Us seeks to enroll one million or more participants, with the goal of improving the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics. Participants will be invited to share different types of health information over time through surveys, electronic health records, physical measurements, biosamples and digital health technologies. Data will be made accessible to researchers for a wide range of health studies, with strict safeguards in place to protect participant privacy. Eric Dishman, director of the All of Us Research Program said, “Collecting real-world, real-time data through digital technologies will become a fundamental part of the program. This information in combination with many other data types will give us an unprecedented ability to better understand the impact of lifestyle and environment on health outcomes and, ultimately, develop better strategies for keeping people healthy in a very precise, individualized way.” As a national leader in research using digital health technologies, Scripps Research is spearheading the program’s digital health effort. In 2017, Scripps Research selected Fitbit as the first wearable for use in the groundbreaking All of Us program, based on the popularity and credibility of its use in peer-validated clinical research. Adam Pellegrini, general manager, Fitbit Health Solutions said, “This is a tremendous opportunity for Fitbit users who choose to participate, to further contribute to one of the world’s largest research efforts by providing information that can help pave the way to a healthier future for all of us. Every day we learn more about the potential for wearable data to inform personalized healthcare and through All of Us, the research community will gain an even better understanding of the role wearable data can play in helping to prevent and treat disease.” A second All of Us research initiative using Fitbit devices will launch in 2019 that involves providing up to 10,000 Fitbit devices to a diverse set of participants randomly invited to take part. The study, which will be conducted by Scripps Research Translational Institute, will generate a unique data set for exploring the relationship between health indicators such as physical activity, heart rate and sleep in conjunction with other critical health outcomes that will be captured as part of All of Us. ]]> https://biospectrumindia.com/news/97/12496/fda-approves-amplatzer-piccolo-occluder-by-abbott.html https://biospectrumindia.com/news/97/12496/fda-approves-amplatzer-piccolo-occluder-by-abbott.html Tue, 15 Jan 2019 12:55:00 +0530 Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved the Amplatzer Piccolo™ Occluder, the world's first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery. One of the most common congenital heart defects occurring in premature babies, PDA is a potentially life-threatening opening between two blood vessels leading from the heart. This channel, which is present in normally developing fetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus' body. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs. PDA accounts for up to 10 percent of all congenital heart disease. Approximately 60,000 premature babies in the U.S. are born each year with a very low birth weight, and nearly 12,000 (one out of five) of these have a hemodynamically significant PDA –a PDA that is large and causes symptoms – which will require urgent treatment for the baby to survive. Evan Zahn, M.D., director of the Congenital Heart Program at Cedars-Sinai's Smidt Heart Institute, and principal investigator for the study that led to FDA approval said, "This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive.” The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. It is designed to allow the physician to insert it through the aortic or pulmonary artery, as well as to retrieve and redeploy the device for optimal placement. Because the device is deployed in a minimally invasive procedure, many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the procedure. The Felkner twins were treated as part of the U.S. pivotal trial, ADO II AS, which helped to support the FDA approval of the device. The trial evaluated the Amplatzer Piccolo Occluder and enrolled 50 patients with a PDA who were older than three days at eight centers across the U.S. The safety and efficacy of the device is further supported by additional experience with the device under a continued access protocol involving 150 more patients. Michael Dale, vice president for Abbott's structural heart business said, "Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts. Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve." The Amplatzer Piccolo device builds on more than 20 years of clinical success for Abbott's family of Amplatzer Occluder therapies, including the Amplatzer™ Duct Occluder II product, already approved for use in the U.S., Europe and countries around the world to treat PDA in larger size pediatric patients.   ]]> https://biospectrumindia.com/news/97/12480/abbott-in-support-of-malaria-elimination-in-odisha.html https://biospectrumindia.com/news/97/12480/abbott-in-support-of-malaria-elimination-in-odisha.html Fri, 11 Jan 2019 16:20:00 +0530 Abbott has announced that it is supporting a partnership between the government of the eastern Indian state of Odisha and Malaria No More, providing technology, expertise and funding support to advance efforts to end malaria in the state.  The partnership builds on Odisha's success in significantly driving down malaria cases and deaths in the last year. With a population of nearly 42 million people, Odisha accounted for about 40 percent of India's malaria burden and one-third of Southeast Asia's malaria burden in 2016. In support of India's 2015 commitment to be malaria-free by 2030, the government of Odisha has prioritized malaria control and elimination. In collaboration with Malaria No More and the government of Odisha, Abbott is supplying 1 million rapid diagnostic tests (RDTs) and technical expertise to strengthen Odisha's malaria detection and surveillance system. In addition, Abbott is providing US$750,000 (INR 52 million) over three years to Malaria No More to back its work with the Odisha government to define and support a comprehensive state malaria elimination strategy that can be used as a model for other states to follow. ]]> https://biospectrumindia.com/news/97/12428/inclusion-of-medical-device-industry-in-dtab-subcommittee-is-a-step-in-right-direction-mtai.html https://biospectrumindia.com/news/97/12428/inclusion-of-medical-device-industry-in-dtab-subcommittee-is-a-step-in-right-direction-mtai.html Mon, 07 Jan 2019 15:30:00 +0530 Medical Technology Association of India (MTaI), which represents research-based medical technology companies having a large footprint in manufacturing and training in India believes that the formulation of DTAB sub-committee to examine proposal for inclusion of compensation in the policy framework on medical devices is a step in the right direction. Pavan Choudary, Chairman and Director General, MTaI said, “The inclusion of Medical Device industry in the subcommittee is a positive step towards having a well-rounded decision on the proposal for inclusion of compensation in the Medical Device Rules. We will work with the expert panel to form a suitable framework on compensation, keeping in mind the interest of the stakeholders.” Drugs Technical Advisory Board (DTAB) which is a panel under the Union Health Ministry has decided to set up a sub-committee to assess the issues related to proposal for amendment of MDR 2017 to include provisions for compensation in case of injury or death due to malfunctioning of medical devices or if the devices are found unsafe or non-compliant with the conditions of licence. The committee is headed by Dr. B.D. Athani, Principal Consultant in Directorate General of Health Services (DGHS) and has representatives of the government, AIIMS and Safdarjung Hospitals, Medical devices industry, and consumers. ]]> https://biospectrumindia.com/news/97/12427/resmed-india-conducts-educational-training-on-non-invasive-ventilation.html https://biospectrumindia.com/news/97/12427/resmed-india-conducts-educational-training-on-non-invasive-ventilation.html Mon, 07 Jan 2019 15:20:00 +0530 ResMed India recently conducted one-day workshop on the application of Non- invasive ventilation in hospital and homecare environment in New Delhi. More than 30 young and aspiring chest Physicians/ pulmonologists attended this workshop. Resmed is involved in the development, manufacturing, and marketing of innovative medical products for the treatment and management of respiratory disorders with a focus on sleep-disordered breathing. ResMed Academy is the clinical arm of ResMed in India that conducts educational workshops for medical experts throughout the year in the fields of NIV and Sleep for education and patient benefit. This workshop covered both theoretical and hands-on learning on the application of Non-invasive ventilation across a variety of patients in various types of respiratory failure including Hypoxemic failure, Chronic care, NIV Guidelines etc. Non- invasive ventilation is the airway support system through an interface such as full face mask which gives positive end-expiratory pressure and improves ventilation – and is very effective in managing various forms of respiratory failure, especially COPD. COPD is a collective term used to describe progressive lung emphysema, chronic bronchitis, refractory asthma and bronchiectasis leading to breathlessness. It is one of the leading causes of deaths in India, especially during winters. Patients benefit from NIV as it provides pressure support and which assists patient’s breathing to enable more volume to enter into their lungs in a shorter period of time. This decreases their work of breathing (WOB) which lowers their respiratory rate and allows more time to exhale. The workshop was headed by Dr. Animesh Arya, Senior Pulmonologist & Sleep Specialist, Action Balaji followed by Dr Bharat Gopal, Dr PP Bose and Dr Arunesh Kumar from Maharaj Agrasen, National Heart Institute and Paras Hospital respectively, who are experts in the field of Non- Invasive ventilation.  Dr Arya spoke about the indications and Goals of NIV whereas Dr Gopal discussed its role in Hypoxemic respiratory failure. In order to spur this application, for the patient benefit or end users, training was followed by experiential learning on NIV application, monitoring and troubleshooting by Dr. Ashwini Mandanna, Clinical Specialist, ResMed India A non-conventional ventilator which people normally believe can be usually used with the mask, maintaining patient’s awake fullness, ability to communicate and eat and drink. This offers the major advantage, avoiding sedation, and patient comfort, ambulation movement), patient recovery, decreased cost to the patient, early discharge On the occasion, Dr.  Animesh Arya said, “NIV has become a first standard of care in various patients of chest diseases with respiratory failure and higher levels of carbon dioxide in blood with early recover. The workshop specifically touched the newer concepts in delivery of NIV to wide range of patients”. “I congratulate, ResMed Academy for conducting such educational workshop that sensitizes and improves the knowledge of upcoming doctors, hence increasing the adoption of NIV.  I look forward to more such initiatives by Resmed”, he added. Dr Bharat Gopal praised ResMed Academy’s effort and said, “Such workshop is important for early usage of technology after proper intensive training, leading to an excellent outcome to patients suffering from flu/ H1N1, and avoidance of ventilation and associated complications”. He also emphasized, on conducting more of such training programs/ workshops in tier 2 and tier 3 cities to spread the awareness. Dr. Arunesh Kumar said, “such workshops are excellent platforms to share experiences and clinical awareness not only to the Medical fraternity but to the supporting staff such as critical care nurses and respiratory technicians”. “I am glad ResMed Academy has taken such initiative of giving hands-on learning experience to all levels of medical support staff” he added A survey claimed 12 lac plus deaths in 2017-18 through both outdoor and indoor pollution. The most common causes and risk factors for COPD are smoking, second-hand smoke, fumes, chemical and dust in construction sites.   ]]> https://biospectrumindia.com/news/97/12422/icmr-nimr-conducts-research-on-malaria-elimination.html https://biospectrumindia.com/news/97/12422/icmr-nimr-conducts-research-on-malaria-elimination.html Mon, 07 Jan 2019 11:00:00 +0530 ICMR-National Institute of Malaria Research (NIMR), New Delhi; National Vector Borne Disease Control Programme (NVBDCP) and Medicines for Malaria Venture, Geneva recently carried out a project ‘Comprehensive Case Management Programme (CCMP)’ in four districts of Odisha. CCMP demonstrated that universal access to malaria diagnosis and treatment, follow-up of patients with enhanced surveillance can dramatically reduce the number of malaria cases. A research paper out of the data of this project 'Improved access to early diagnosis and complete treatment of malaria in Odisha, India has also been published. Dr Balram Bhargava, Secretary, Department of Health Research and Director General, ICMR said that the work of Sir Ronald Ross on malaria transmission was carried out in India. He stated that India is committed to malaria elimination by year 2030. Already there has been significant progress in bringing down the caseload. ICMR has been carrying out research that has been relevant to the elimination of various diseases from the country and CCMP is an example of such research. CCMP is a sustainable model for improving access to malaria control tools in hard-to reach areas, and other states could take a cue from this, and intensify efforts towards malaria elimination, he added. ]]> https://biospectrumindia.com/news/97/12408/india-pharma-2019-india-medical-device-2019-to-be-held-in-bengaluru-.html https://biospectrumindia.com/news/97/12408/india-pharma-2019-india-medical-device-2019-to-be-held-in-bengaluru-.html Thu, 03 Jan 2019 16:25:00 +0530 The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, along with Federation of Indian Chambers of Commerce & Industry (FICCI), is organising the 4th International Conference on Pharmaceutical & Medical Device sector on 18th – 19th February, 2019 in Bengaluru.  The theme for India Pharma 2019 is ‘Enabling Quality Affordable Healthcare’ and that of India Medical Device 2019 is ‘Med-Tech India: Gearing up for Ayushman Bharat’. V. Sadananda Gowda, Union Minister for Chemicals & Fertilizers and Statistics & Programme Implementation while addressing the media during the Curtain Raiser Press Conference for India Pharma 2019 & India Medical Device 2019 said, “Endevour of the Government is to provide affordable quality healthcare for all and boost indigenous pharma sector through ‘Make in India’. In this direction, Cabinet has given approval for 100 % FDI under automatic route for manufacturing of medical devices." He will inaugurate the two-day event, which is India’s biggest Global Conference on Pharma Industry and Medical Devices, and address the distinguished gathering in the presence of Mansukh L. Mandaviya, Minister of State for Chemicals & Fertilizers and Road Transport & Highways, Shipping. “The flagship event would bring key stakeholders of the pharma and medical devices sectors under one roof and provide an opportunity to discuss Government policy and challenges facing the Industry. Government is striving to make the processes in the sector as transparent and easy as possible.” Mansukh Mandaviya informed the gathering that, “the 4th edition of the event will have brainstorming sessions on  various aspects of Pharmaceuticals and Medical Device sector and in its 4th edition the event will help in resolving the bottlenecks of growth in the sectors.” Talking on the rationale of holding the annual conference, J.P. Prakash, Secretary (Pharmaceuticals) said that, “the event is held annually to get new and innovative ideas from all stakeholders in the conference. This helps the department to prepare the annual action plan for the Pharma and Medical Device Sectors. During the Conference, the annual action taken report on the issues raised at the last edition of the event, along with new areas of concern, will be discussed.” In the main event in Bengaluru, over 150 CEOs of the global pharma and medical device industry are expected to participate. International Drug Regulators from 15 countries have been invited to the event for interaction with Indian Drug Regulators and Industry Regulatory Officers. Ambassadors  & Commercial Counsellors of more than 50 countries have been invited for close interaction with Government of India and participating Industry. Thematic sessions will be held on areas of Artificial Intelligence in Pharma, Import Export issues, Biologicals, Biopharmaceuticals and New Chemical Entities (NCEs) for the Pharmaceutical Sector. For the Medical Devices Sector, thematic sessions will be held on Diagnostics Ecosystem, Ease of Doing Business and Health Technology Assessment (HTA) Framework. Technical workshop by World Health Organization will help in addressing key challenges before the industry and will also provide tremendous business linkages to the participating companies. The annual India Pharma & Medical Device Awards will be conferred by Department of Pharmaceuticals for various categories including India Pharma Leader Award, Innovation of Year Award, Bulk Drug Company of the Year Award and Medical Device Company of the Year Award. Other dignitaries present on the occasion today included Navdeep Rinwa, JS (Pharmaceuticals), Rajneesh Tingal;  Shubhra Singh, Chairperson, NPPA; Dr. S. Eswara Reddy, DCGI; and Dilip Chenoy, SG, FICCI. ]]> https://biospectrumindia.com/news/97/12407/eris-life-sciences-join-hands-with-medtronic-.html https://biospectrumindia.com/news/97/12407/eris-life-sciences-join-hands-with-medtronic-.html Thu, 03 Jan 2019 16:15:00 +0530 Pharma company Eris Lifesciences and medical technology company Medtronic Pvt. Ltd has announced their collaboration for a diabetes monitoring initiative in India. The two companies will utilize their respective strengths in helping patients monitor their diabetes better.  Medtronic will bring to India its latest US FDA approved Guardian™ Connect device for real-time evaluation of glucose variability in diabetes patients.  Eris through its national reach will provide the device at clinics and healthcare delivery units under its patient care initiative. Guardian Connect is the world’s first Smart Continuous Glucose Monitoring System connected with smartphone displays for real-time data viewing of glucose levels, without a separate hardware monitor.  Guardian Connect is a cutting edge device that stands out with built-in mechanisms for sending out alerts predicting high and low blood sugars 10-60 minutes in advance. These alerts pop up on the user’s smartphone (or Apple Watch) as notifications, just like regular text messages that pop up at regular intervals on mobile phones. The device also includes features like remote monitoring alerts via text messages and a web app that can be accessed from any internet-connected device. For example, in juvenile diabetes, a parent could view their child’s CGM data and receive alerts for low and high measurements in real-time. Commenting on the development, Amit Bakshi, Chairman and Managing Director, Eris Lifesciences said, “For better patient outcomes in diabetes, we believe that a holistic approach of medicine, diet and continuous monitoring is important. Technology has emerged as a great enabler in healthcare. While technology is transforming healthcare delivery, on the patient and physician end there is a need to create more awareness of how to use technology and how technology can make managing diabetes easier. Through this initiative, we aim to make patients and physicians adopt newer technologies for better health.” Describing the benefits of the collaboration, Madan Krishnan, Managing Director & Vice President, India Medtronic Pvt. Ltd., said, “Medtronic’s innovations in the space of Continuous Glucose Monitoring and Insulin Pumps has transformed diabetes management. Guardian Connect is a technological breakthrough that will change the diabetes treatment landscape. It empowers the patient to take control in real-time and the physician to be fully-equipped with data and evidence. In a large country like India, with high incidence of diabetes, we are happy to align with a partner who understands the challenges of diabetes management and has the reach to take our solutions across the country.” Although India has one of the highest incidence of diabetes, diagnosis and monitoring remain a challenge. Monitoring sugar levels is a critical element of managing diabetes. From the earlier blood glucose monitors (prick and test blood) to the new-age continuous monitoring device like Guardian Connect which has a small transmitter, mobile app and disposable sensor, monitoring glucose level has become very convenient and painless.   ]]> https://biospectrumindia.com/news/97/12371/edwards-sapien-3-ultra-transcatheter-heart-valve-gets-fda-nod.html https://biospectrumindia.com/news/97/12371/edwards-sapien-3-ultra-transcatheter-heart-valve-gets-fda-nod.html Fri, 28 Dec 2018 15:45:00 +0530 Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery. "The advanced SAPIEN 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our best-in-class performance of SAPIEN 3 to further advance and improve patient care," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "We look forward to introducing the SAPIEN 3 Ultra system to U.S. patients." The SAPIEN 3 Ultra system builds on Edwards' decades of engineering and experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves.   ]]> https://biospectrumindia.com/news/97/12362/siemens-healthineers-introduces-a-mobile-c-arm-cios-fit.html https://biospectrumindia.com/news/97/12362/siemens-healthineers-introduces-a-mobile-c-arm-cios-fit.html Thu, 27 Dec 2018 16:45:00 +0530 Cios Fit-a multidisciplinary mobile C-arm ready for demanding environments, was introduced at the 63rd Annual Indian Orthopaedic Association Conference (IAOCON), Coimbatore, on November 28th, 2018; setting a benchmark in mobile C-arms. It was inaugurated by Dr.S Rajasekaran, Chairperson of AOSpine (International community of Spine Surgeons, headquartered in Switzerland). Cios Fit is designed to help in improving quality of care, achieve efficient workflows, and profit from high uptime; thereby reducing avoidable costs. It is built for the tough job in the Operation Room (OR) where the equipment needs to deliver high quality imaging, be simplified in its usage and robust to last for long; while ensuring price point is not exceeded. With Cios Fit-powerful imaging technology, the surgeons are able to maintain consistency with crystal clear images of anatomical structures, implants, screws and devices resulting in accurate treatment and thus improving patient experience. ]]> https://biospectrumindia.com/news/97/12355/lybrate-launches-goodmd.html https://biospectrumindia.com/news/97/12355/lybrate-launches-goodmd.html Thu, 27 Dec 2018 11:40:00 +0530 India’s first online doctor consultation, Lybrate has launched GoodMD which is an exclusive social networking platform for doctors, where they can destress themselves in the midst of their busy and tiresome lives, as also voice their opinions on multitude of issues related to healthcare, including regulatory and administrative, without the inhibition of being judged. GoodMD was launched realizing the lack of a relevant online space for healthcare practitioners where they can exchange opinions with fellow doctors and bust their stress. Given the burnout level of doctors getting high, GoodMD is a gateway for them to relax and express themselves freely. The platform provides an outlet to their pent-up thoughts, find solidarity from peers to what and how they feel, share their clinical expertise with fellow colleagues, check out what their peer group has posted and stay updated on pharma, patientcare, business-related and other developments in the healthcare industry via Medshorts, which keeps them posted about healthcare-related news in just 360-characters. GoodMD is a first-of-its-kind professional-cum-personal social networking platform for doctors which is only meant for them. Guided by the approach of inclusiveness, the platform aims to bring together doctors from across specialties, including AYUSH, and multiple backgrounds to help them forge a healthy professional bond. The platform has shown doctors joining hands like never before and vociferously express their thoughts on issues whether it was Prime Minister Narendra Modi’s remarks on Indian doctors in London or celebrating a doctor’s achievement or exemplary work a fellow doctor has performed. The platform has allowed doctors to engage in fruitful discussions on critical issues such as NMC Bill or Bridge Course, promoting diversity of thoughts, which is essential to strengthen the medical community.    Saurabh Arora, Founder and CEO, Lybrate said, “With Lybrate, we have built a huge network of doctors. We saw that doctors can connect with their family and friends on Facebook, they can connect with all kinds of professionals on LinkedIn, but they had no online platform to ‘engage’ with their peer group only. GoodMD provides doctors a platform to not just connect with each other and relax, but also allow them to express their thoughts on certain issues exactly in the way they feel about them.” “On some issues, the fraternity has consensus on the platform, while on some doctors do not shy away from sharing their discontent or disagreement with their fellow colleagues. This kind of action was missing when it came to doctors on a social media platform. GoodMD has filled that void for doctors,” he added. Over 70,000 doctors from across specialties are currently on GoodMD and the aim is to bring all the doctors in the country on the platform.   ]]> https://biospectrumindia.com/news/97/12334/industry-stalwarts-attend-various-transasias-conferences-organized-throughout-the-year-.html https://biospectrumindia.com/news/97/12334/industry-stalwarts-attend-various-transasias-conferences-organized-throughout-the-year-.html Sat, 22 Dec 2018 09:05:00 +0530 It’s that time of the year, when the industry and academia blend together to be part of a carnival of national and state level conferences and seminars, to contemplate on the future clinical advancements. Year on year, Transasia Bio-Medicals Ltd, India’s leading IVD Company, has been an active contributor; by bringing together its subject experts as well exhibiting its latest systems, all in an effort to pave the way for better healthcare outcomes. Held between 24th - 27th October at Goa, the 45th National Conference of Association of Clinical Biochemists of India (ACBICON) hosted faculty from across the world, who shared their expertise on varied topics of interest such as cancer genomics, micro RNAs as novel biomarkers and tools for personalized cancer diagnostics, amongst others. Around the same time, the 43rd Annual Conference of Indian Society of Blood Transfusion and Immunohematology (TRANSCON 2018) a dedicated platform for transfusion medicine specialists, was held from the 26-28th October at Vizag. As a principal partner at both events, Transasia welcomed some of the leading names from the IVD industry for insightful discussions at its booth. Additionally, at ACBICON it also exhibited some of its best clinical chemistry solutions, offering a throughput from 200 - 1000 tests/ hr. On the other hand, at TRANSCON, it showcased its complete range of blood banking solutions, right from its ELISA panels to fully automated processors for efficient workflow management. Among the very few companies who offer ELISA panels for Transfusion Transmitted Infections (TTI), Transasia’s portfolio is targeted to all the five important infections (HIV, HCV, HbsAg, Syphilis and Malaria). Besides this, it also offers ELISA panel and rapid test kits for dengue and malaria. Moreover, Transasia also announced its soon to be launched rapid test kit for Syphilis. Both the events received an overwhelming response from over 300 delegates from across India. Moving on to November, at the 7th National Conference of Indian Society of Transfusion Medicine- TRANSMEDCON held between 23rd- 25th November at Kochi, Transasia made its presence felt and how! A unique engagement activity at the Transasia stall - a Kathakali dancer as a selfie-point, turned out to be quite a crowd-puller! Here too, Transasia showcased Elan 30s - a fully automated ELISA processor. Among the over 100 visitors at the booth, some of the leading names included Dr. Joy Mammen from CMC Vellore, Dr. Anitha Balakrishnan from IMA Kollam and Brig. (Dr.) P.S. Dhot from SMC, Ghaziabad. From south to the north, the Transasia team was next seen at Bareilly for APCON 2018 between 28th November- 2nd December catering to the over 100 pathologists, who visited the Transasia booth. Transasia exhibited its state-of-the-art products in biochemistry, coagulation, urinalysis and hematology, besides introducing its latest, touchscreen ESR analyzer, Ves30 touch. This was then followed by the 2nd Annual Conference of Vidarbha Association of Pathologists & Microbiologists (VAPCON) held between 8th- 9th December at Nagpur. In addition to exhibiting its products at the booth, Transasia also organized scientific session on Clinical utility of advanced hematology parameters by Dr. Roshini Shekhar of Manipal Hospitals. The 5th Annual Conference of The Association of Practising Pathologists (APP) - PATHCON & LAB EXPO 2018 was held on 15th-16th December at New Delhi. Transasia clearly stood out from the rest with its extensive spread of semi and fully automated analyzers in all areas of diagnosis. Additionally, it also arranged scientific sessions by industry stalwarts such as Dr. (Col.) Jyoti Kotwal and Dr. Jasmita Das from SGRH, New Delhi; Dr. Swati Pai from Manipal Hospital, Bengaluru and Dr. (Col.) S. Venkatesan from AFMC, Pune. Transasia’s holistic efforts won it the ‘The Best Participation Award’. The end of the season was marked by another whole-hearted participation in the GAPM conclave 2018, organized by the Gujarat Association of Pathologist & Microbiologists on 15th – 16th December at Ahmedabad. Here too, Transasia exhibited all its advanced technologies to the over 650 visitors who made it a grand success!   ]]> https://biospectrumindia.com/news/97/12331/3hcare-in-expands-with-offline-path-lab.html https://biospectrumindia.com/news/97/12331/3hcare-in-expands-with-offline-path-lab.html Fri, 21 Dec 2018 17:00:00 +0530 As a part of an aggressive plan to expand its offline footprints throughout India, leading online healthcare portal 3hcare.in, recently launched its first diagnostic lab. The online portal has started off with Kosi and is planning to gradually ramp up in other locations in Haryana and western UP soon.  The pathology labs will operate under the name ‘3Hcare Labs’ which assures same day delivery of reports and free home sample collection to all the neighboring customers. The lab is undergoing ISO certification and will soon be receiving NABL accreditation.   With tier 3 & tier 4 cities devoid of even the basic healthcare services like diagnostics, are in demand for critical attention. With advancements in the technology, basic pathology labs do not necessarily require the presence of specialized doctors but in fact, through its command centers reporting of test results can be done with ease and the patient can be directed for the right treatment.   Due to the absence of qualitative certification and entry barriers, local diagnostics in tier 3 &4 cities are thriving. In such a scenario, 3hcare labs (which is well established as 3hcare.in is the online segment) has a greater scope for penetration and a stronghold in these villages and towns in the offline segment as well.   There is a change in the pattern of disease, now more and more lifestyle-related ailments like diabetes, hypertension, cholesterol, and cardiovascular disease are on the rise which is not only confined to tier 1 city. Around 30-35% of the total cases are reported from tier 3 & 4 cities, which needs to be managed through regular tests. To cater to quality services, 3Hcare Labs offers better and consumer-friendly services like home sample collection and timely reports.   The online portal that has been pioneering in providing the best diagnostics services at the doorsteps also provides plan my surgery feature to get timing and availability of treatment or surgery from the best-accredited hospitals across India. ]]> https://biospectrumindia.com/news/97/12325/cancer-institute-wia-launches-indias-first-molecular-lab-for-cervical-cancer-screening.html https://biospectrumindia.com/news/97/12325/cancer-institute-wia-launches-indias-first-molecular-lab-for-cervical-cancer-screening.html Fri, 21 Dec 2018 10:15:00 +0530 Roche Diagnostics India has announced the launch of its HPV (Human Papilloma Virus) DNA screening solution at ‘Cancer Institute (WIA)’ making it India’s first Molecular Laboratory for Cervical Cancer Screening. Persistent infection with high-risk HPV has been established to be the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. It can take 10 to 15 years or longer for cervical cancer to develop, so regular screening to know a woman’s individual risk and finding disease early, before cancer develops, is an important prevention strategy. The molecular lab launch event which discussed at length the need for screening of cervical cancer saw the presence of dignitaries namely Dr. J Radhakrishnan, Principal Secretary (Health and Family Welfare), Government of Tamil Nadu, Dr. V Shanta, Chairperson, Cancer Institute (WIA), S N Pandey, Managing Director, Chennai Petroleum Corporation Limited and Dr. Shravan Subramanyam, Managing Director, Roche Diagnostics India. India accounts for 20 percent of world-wide prevalence for Cervical Cancer, and has an incidence and mortality rate higher than most regions, including South East Asia. More than 1.2 lakh cervical cancer cases are detected in India annually, making it the second leading cause of cancer after breast cancer. Chennai stands fourth among the top registries in India with the highest incidence of cervical cancer in women, according to a report from the ICO HPV Information Centre. According to National Cancer Registry Programme and World Health Organisation, Chennai has reported more of age-adjusted prevalence of the disease. Dr. V Shantha said, “Cervical cancer is preventable, hence, adopting a comprehensive approach that includes vaccination, effective screening, early diagnosis and treatment has the potential to reduce the existing mortality relating to this cancer. In India, the absence of organised screening programs have contributed to this situation. We in Tamil Nadu, however, have implemented a State-wide cancer registry and the Government of TN has been running a state-wide screening program.” Speaking at the event, Dr Shravan Subramanyan said, “Roche Diagnostics with its molecular HPV DNA testing has been globally partnering with prestigious Government and private health institutions to enable prevention and early diagnosis of cervical cancer. In India and especially in Tamil Nadu, where the incidence of this completely preventable cancer is high, with the Cancer Institute’s progressive molecular testing lab, we can start making a difference to women’s lives. That this facility is going to be available to women across the State, especially for women in vulnerable communities makes it fulfilling. I am confident that our discussions with the forward-thinking TN State Government will help us implement HPV DNA-based cervical cancer screening across the State to help prevent cervical cancer and save valuable lives.” Currently, the most commonly used method of screening employed in the developed world is cytology based Pap smears, which has contributed considerably to reducing incidence of, and mortality from, cervical cancer. Another screening method is HPV DNA testing, which has higher sensitivity vis-à-vis cytological screening, and can detect more precancerous lesions than cytology. Hence, it can be implemented with longer intervals between screenings and can potentially help in reducing cervical cancer incidence, and averting more deaths from the disease.   ]]> https://biospectrumindia.com/news/97/12316/mtai-welcomes-governments-decision-to-create-nmdpc.html https://biospectrumindia.com/news/97/12316/mtai-welcomes-governments-decision-to-create-nmdpc.html Thu, 20 Dec 2018 09:55:00 +0530 Medical Technology Association of India supports central government’s decision to set up a National Medical Devices Promotion Council (NMDPC) and  boost the Medical Device Industry in India. Suresh Prabhu, The Union Minister of Commerce and Industry and Civil Aviation at the 4th WHO Global Forum on Medical Devices has pointed out that the National Medical Devices Promotion Council (NMDPC), headed by the Secretary, DIPP, would achieve the much needed convergence as medical devices were previously being covered under various Ministries and departments. This will facilitate formulating better regulatory system in the medical devices sector. Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) said, “Within the overall health ecosystem, medical devices has remained a sector where focused attention is much required. Medical devices are different from other healthcare industries as they develop and grow based on a dynamic innovation and manufacturing ecosystem. Such a system is often born with the help of global legacy technology companies and also allows indigenous entrepreneurs and physicians to create and bring to market local medical technology. We welcome the government’s decision to create a National Medical Devices Promotion Council (NMDPC) to boost the Medical Device Industry and MTaI will help in strengthening this ecosystem.” The Medical Devices Industry (MDI) plays a critical role in the healthcare ecosystem. The manufacturing and trade in MDI is growing steadily in India. Currently with sufficient manufacturing capacity for low cost low risk devices such as surgical gloves; blood bags; extension lines, stop cocks, some IV access products and syringes, India is yet to see extensive growth spikes in high tech medical devices. To ensure patient safety, the industry is investing and focusing on constant technological innovation and upgradation. While the medical devices industry has been growing in double digits it is predominantly import-driven for medical devices with imports accounting for over 70% of the domestic market and around 80% for critical-care devices. The setting up of NMDPC will address the issue of expansion of domestic manufacturing for critical-care devices. The NMDPC order mentions about the robust Preferential Market Access (PMA) policy discouraging unfair trade-practices in imports. “Robust tracking mechanisms from the government to streamline all trade practices have always been welcomed by all MTAI member companies. Our member companies strictly abide by stringent Drugs & Cosmetics Act and Tax (transfer pricing) laws,” added Pavan Choudary. MTAI is looking forward to industry consultation as mentioned in the NMDPC order to set up a robust and dynamic preferential market access policy post industry feedback, trade interventions, emulating global best practices consulting multinational legacy companies.  “There is a requirement to bring in regulations which would incentivize global companies to invest in Indian companies through equity or sweat equity. This will not only attract more global companies to invest in India but also as a result lead to increase in FDI.” said Pavan Choudary. "The last instance being when the current government brought FDI in medical technology on the automatic route on our recommendation and the FDI inflow sky rocketed from $63 million annually to $440 million annually in a span of less than two years”, he added. Global companies support the Make-in-India program and expect a fair opportunity to contribute to the Indian patients with their global products and have proved their worth time and again.   ]]> https://biospectrumindia.com/news/97/12308/jaslok-hospital-and-research-centre-installs-cryogatt-system-for-ivf.html https://biospectrumindia.com/news/97/12308/jaslok-hospital-and-research-centre-installs-cryogatt-system-for-ivf.html Wed, 19 Dec 2018 11:05:00 +0530 Jaslok Hospital and Research Centre takes first of its kind initiative by installing Asia's first Cryogatt System for IVF (In-Vitro Fertilization). Cryogatt has developed Globally-Unique patented RFID systems which operate at accepted safe levels for delicate biomedical samples. During IVF, there is usually a surplus of embryos and this technique will help in storing and tracking the embryos. With the help of the Cryogatt System in terms of Safety measures; Radio Frequency Safety Net help detect the embryos, Sperm and eggs. Fertility clinics can now safely, quickly and accurately identify and audit. Dr Firuza Parikh, IVF Specialist at Jaslok Hospital and Research Centre was quoted saying, "We are thrilled to have always been amongst the first centres in the world to harness new technology to provide the highest quality care for our patients. For the people who have a blocked tube, IVF provides the best opportunity of having a child using their own eggs. Couples with male infertility problem might have a much higher chance of conceiving with IVF than conceiving naturally. People who suffer from PCOS (Polycystic Ovary Syndrome), where there is a hormone imbalance leading to irregular menstrual cycles. IVF has been proven very successful in patients with PCOS, who will not conceive with ovulation induction. Many other problems like these can be taken care of with the help of IVF and it can help people have a family of their own.” George Alex Chief Marketing Officer and Chief Operational Officer at Jaslok Hospital and Research Centre said, “IVF helps patients who are unable to conceive. Medicines and procedures required for IVF rarely are associated with problems or complications. While many couples who are unable to bear children opt for IVF, doctors, nurses, technicians and staff of Jaslok Hospital will be there with you every step of the way, providing you with the comfort, support and expertise you need. Dr Firuza Parikh, further added saying, "Embryos, sperm and ova can be indefinitely stored at -196 degrees Centigrade. The samples are traditionally placed in vials that are either bar coded or labelled manually. One has to be very careful that there is no mix up of biological samples. Sometimes the labels can become unstuck on defreezing. Also the correctly labelled straw has to be identified and removed from the other samples in less than 15 seconds. Any longer exposure can damage the biological material." IVF also helps patients to avoid passing on certain genetic conditions, and allows hopeful parents to plan having children after establishing a career or achieving other milestones. The launch resulted in safeguarding the samples using fast, faultless RFID solutions.     ]]> https://biospectrumindia.com/news/97/12300/3d-printing-to-prepare-businesses-for-industry-4-0.html https://biospectrumindia.com/news/97/12300/3d-printing-to-prepare-businesses-for-industry-4-0.html Wed, 19 Dec 2018 09:00:00 +0530 Stratasys India, a subsidiary of Stratasys, organized the 2nd edition of Stratasys India User Forum 2018 in Bengaluru recently. This 3D printing forum is an annual industry congregation hosted by Stratasys to promote the adoption of 3D printing technology across the region. The forum strives to provide a platform for key industry players and end-users to exchange insights on the latest 3D printing trends, applications, and best practices. On this occasion, Stratasys announced a collaboration with NTTF (Nettur Technical Training Foundation) to launch India’s first additive manufacturing certification course. This training program is designed to help students to learn new technologies in 3D printing and make them future industry ready. Themed ‘Shaping what is Next’, the event witnessed coming together of Stratasys leaders, industry bests and end-users, to share knowledge on the latest 3D printing trends. 3D printing demonstrations in manufacturing, automotive, aerospace & defence, healthcare, and education were showcased during the event. These are some of the key sectors likely to see the highest 3D printing adoption according to solution users and industry speakers at the forum. Commenting on the occasion, Rajiv Bajaj, Managing Director, India & SEA, Stratasys said “3D printing has immense growth potential in India, but the uptake has to be faster. We notice there is a lack of awareness on the diverse applications of 3D Printing. Companies usually hold back on innovation ignorant of cost-benefit ratio, which if taken into consideration can help businesses deliver solutions faster, cheaper, better and easier. Stratasys India User Forum strives to bridge this gap and provide a platform for industry leaders to exchange knowledge and discuss the ever-changing dynamics of the industry.” On the healthcare track, the speakers presented interesting case studies that highlighted the uses of 3D printing  in the field of healthcare. Ravi Shankar, Managing Director, Accreate Additive Labs shared his views on how bioprinting is soon to become a trend leading towards the area of 4D printing. Chetan Pakhare, Research Assistant, IIT Bombay- Biomedical Engineering and Technology (Incubation) Centre spoke on the potential 3D printing is offering to develop innovative and customised medical devices. Dr. Sanjeev Kumar, Senior Scientist, Biomedical Instrumentation Unit, Assistant Professor, Academy of Scientific and Innovative Research (AcSIR), CSIR-Central Scientific Instruments Organisation (CSIR-CSIO) focused his opinion on the applications and advantages of 3D printing in the healthcare sector. ]]> https://biospectrumindia.com/news/97/12301/lumenis-india-tmh-organise-workshop-for-otolaryngologists.html https://biospectrumindia.com/news/97/12301/lumenis-india-tmh-organise-workshop-for-otolaryngologists.html Wed, 19 Dec 2018 09:00:00 +0530 Lumenis Ltd, world’s largest energy-based medical device company for surgical, aesthetic and ophthalmic applications, recently organized a two-day laser workshop for head & neck oncologists at India’s best cancer treatment and research Centre, The Tata Memorial Hospital in Mumbai. The event was specially designed to provide training for oncologist surgeons practicing in the field of head & neck oncology. Various eminent doctors conducted knowledge enhancement sessions using breakthrough laser technologies namely AcuPulse DUO, used widely in trans-oral laser microsurgery. AcuPulse DUO CO2 laser microsurgery is most beneficial in delicate and precision surgical procedures. Unlike open surgery, CO2 lasers can remove cancer with fewer disturbances to structures, nerves, and tissue. Due to the minimally invasive operative method, CO2 lasers are increasingly becoming a first line treatment of early stage airway cancers, especially in the larynx. Professor Vinidh Paleri, Consultant Head & Neck Surgeon, The Royal Marsden NHS Foundation Trust, UK said “ We’ re are very thankful to Lumenis for bringing all doctors together on the same platform and help keeping the doctors abreast with the latest technology. The AcuPulse DUO is a versatile technology which enable us to address surgical challenges and broad range of clinical indications with precision”. Professor Prathamesh S. Pai, Consultant Surgeon, Convener- Head Neck Disease Management Group, Department of Head Neck Surgical Oncology, Tata Memorial Centre, Mumbai, said, “Lumenis has always been a front runner when it comes to imparting knowledge sharing session to the medical fraternity. Such regular workshops keep doctors abreast with the latest and path-breaking technology available in medical filed”. On the occasion, Bijal Shah, Country Manager, Lumenis India, said, “As a leader in energy based medical device market, we are proud to be associated with India’s leading specialist cancer & research center, Tata Memorial Hospital to conduct such scientific sessions, enhancing doctor’s knowledge and abreast them with latest laser advancements available in market. The live demonstrations and hands on sessions organized with Lumenis technologies like AcuPulse DUO makes it more experiential and promotes real-time learning for doctors”. Along with the hands on training using laser techniques the workshop includes theoretical session like basics of laser technology, application of lasers in Head & Neck cancers, Speech & Swallowing and Narrow Band Imaging. The other distinguished faculty of the workshop were Dr Rakesh Shrivastava, Prof. Alok Thakkar, Dr Pankaj Chaturvedi , Dr Sudhir Nair, Dr Deepa Nair, Dr Gouri Deshmukh , Dr Anuja Deshmukh among others. ]]> https://biospectrumindia.com/news/97/12273/venture-center-invests-in-healthcare-startup-dee-dee-labs.html https://biospectrumindia.com/news/97/12273/venture-center-invests-in-healthcare-startup-dee-dee-labs.html Mon, 17 Dec 2018 09:00:00 +0530 Technology startup incubator Venture Center has invested an undisclosed amount of seed funding in healthcare startup Dee Dee Labs, which aims to restore anatomical function lost by amputation, under the NIDHI-SSS (National Initiative for Developing and Harnessing Innovations-Seed Support System), an umbrella programme of the DST (Department of Science & Technology) of Government of India. Speaking on the development, Pratik Bhalerao, co-founder Dee Dee Labs, said “The funds will mainly be used to strengthen our R&D effort for product development and pilot testing of the prototype. This will help us to reach to a stage where we can show the alpha version of the product and apply for the subsequent funding opportunities.” Dee Dee Labs, based at Venture Center, is a R&D startup company working in the healthcare domain. They are working on a non-invasive multigrasp myoelectric prosthetic arm for transradial amputee population in India and the Indian subcontinent.  Their bionic arm technology platform is designed to restore anatomical function, lost by amputation, by using intelligent hardware and algorithms that can respond in a human-like way. “DeeDee Labs has the potential to serve an unmet need for affordable and empowering upper limb prosthetics. While doing so, the company is developing a platform that can be applied to many other applications in assistive technology products,” said Dr. Premnath, Director, Venture Center who is very optimistic of large market growth in these sectors in the coming years. ]]> https://biospectrumindia.com/news/97/12269/dipp-initiates-national-medical-devices-promotion-council.html https://biospectrumindia.com/news/97/12269/dipp-initiates-national-medical-devices-promotion-council.html Fri, 14 Dec 2018 17:00:00 +0530 Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) applauded and thanked DIPP (Dept of Industry Policy and Promotion) for the great initiative of the creation of the much needed National Medical Devices Promotion Council which will provide an impetus and boost Indian Medical Devices manufacturing industry and support the Make in India impetus for Medical Devices in India.  Suresh Prabhu, Minister of Commerce and Industry has officially announced the establishment of the National Medical Devices Promotion Council at World Health Organisation's global conference on medical devices in Visakhapatnam. He also announced establishing a Medical Devices Design Centre and assured as exports picks up we will also establish a Medical Devices Exports Promotion Council.   It’s been more than Thirteen years since a direction was given to the Indian health authorities to have a comprehensive framework for medical devices. Such concerns recently got amplified on a global scale following an investigation into medical devices by media entities. The reportage revealed the opaqueness around this industry.  Nath said “We are also most grateful to AMTZ- Andhra Pradesh MedTech Zone and Andhra Pradesh Govt. led by the leadership of Shri Chandra Babu Naidu for offering to host the prestigious WHO Global Conference on Medical Devices.”  The Prime objectives of the National Medical Devices Promotion Council are:  Act as a facilitating and promotion & developmental body for the Indian Medical Devices Industry Hold periodic seminars, workshops  to deliberate on various parameters for inclusion in the industrial and trade policies in medical devices Identify redundant processes and render technical assistance to the agencies/departments concerned inorder to simplify the approval processes involved in medical device industry promotion and development Enable entry of emerging interventions and support certifications for manufacturers to reach levels of global trade norms and lead India to an export driven market in the sector Support dissemination and documentation of international norms and standards for medical devices, by capturing the best practices in the global market and facilitate domestic manufacturers to rise to international level of understanding of regulatory and non regulatory needs of the industry Drive a robust and dynamic Preferential Market Access  (PMA) policy, by identifying the strengths of the Indian manufacturers and discouraging unfair trade practices in import; while ensuring pro-active monitoring of public procurement notices across Indian to ensure compliance with PMA guidelines of DIPP/DoP Undertake validation of Limited Liability Partnerships (LLPs) and other such entities within MDI sector, which add value to the industry strength in manufacturing to gain foothold for new entrants Make recommendations to government based on industry feedback and global practices on policy and process interventions to strengthen the medical technology sector including trade interventions for related markets Nath further pointed out that the way Pharmaceutical Export Promotion Council of India (Pharmexcil) was successful in promoting the Indian Pharmaceutical Industry, we are similarly hopeful that Medical Devices Development Council will help realise our vision for India to be among the Top 5 Medical Devices manufacturing hubs worldwide as the Council will spearhead the policy needs to accelerate the manufacturing of medical devices in India and end the 70-90% import dependence forced upon us and an import bill of over Rs 31, 000 crore. The Indian market at retail and institutional level is estimated to be at over Rs. 70000 Cr (10 Billion $).  “We are glad Govt. is taking serious steps to make India a global robust hub for medical devices manufacturing and fulfilling Govt’s ambitious mission of making quality healthcare affordable for common masses” concluded Mr. Rajiv Nath. ]]> https://biospectrumindia.com/news/97/12253/hinduja-healthcare-surgical-receives-accreditation-for-tavi.html https://biospectrumindia.com/news/97/12253/hinduja-healthcare-surgical-receives-accreditation-for-tavi.html Thu, 13 Dec 2018 10:25:00 +0530 Hinduja Healthcare Surgical (HHS) becomes one of the first hospitals in Mumbai/Maharashtra to get accreditation for conducting Transcatheter Aortic Valve Implantation (TAVI), a highly specialized lifesaving cardiac procedure. TAVI is a minimally invasive procedure for treating abnormal narrowing of aortic valve known as aortic stenosis. TAVI is a US FDA approved procedure. TAVI is an alternative for the surgery that is normally done for valve replacement and is done for people at high surgical risk due to age and other complications. In this procedure, a new valve is fixed with the help of a specialised catheter. This is done without removing the old, damaged valve and without opening the patient’s chest. Surgical valve replacement of elderly patients is a high risk process as it requires open heart surgery which is not recommended due to factors like age, other ailments, previous bypass surgeries etc. Dr. Haresh Mehta, Consultant Cardiology, Hinduja Healthcare Surgical, Khar, recently operated on an 87 years old patient at the hospital adopting the TAVI procedure. It is the latest revolutionary technology in treating heart valve defects and is better in terms of safety and efficacy.  “Aortic stenosis (abnormal narrowing of aortic valve) increases the stress and strain on the heart muscle, resulting in anxiety which in turn can lead to various symptoms like chest discomfort, shortness of breath, fatigue, lightheadedness, unconsciousness, and even sudden death. If not treated, 50% of these patients can face higher risks or mortality within one to two years from the onset of symptoms”, explained Dr. Haresh Mehta “The prevalence of aortic stenosis has a considerable impact on the elderly people in India. About 4.5 lakh patients, remain untreated in India due to treatment gap. TAVI accreditation is an accomplishment to reduce these gaps and provide best services with efficient technology. This procedure is a minimally invasive procedure and is a saviour to the patients with severe symptoms of aortic stenosis”, added Dr. Mehta. ]]> https://biospectrumindia.com/news/97/12238/5th-international-congress-of-indian-cartilage-society-concluded-at-jaipur.html https://biospectrumindia.com/news/97/12238/5th-international-congress-of-indian-cartilage-society-concluded-at-jaipur.html Tue, 11 Dec 2018 11:35:00 +0530 The 5th International Congress of Indian Cartilage Society (ICS) was recently held in the Rajasthan capital Jaipur where specialists discussed on measures to ensure the health and longevity of human body’s natural joints for a long time with the help of cartilage regeneration and restoration.  The main theme of this year’s conclave was: “Regeneration is better than replacement.”  Inaugurating the conference, Dr. Ryder said, New techniques of cartilage regeneration and restoration have now triggered the hope that knee and other joints which become defective and worn out because of osteoarthritis and other causes may not be required to get replaced. Instead, natural joints should be repaired and rejuvenated through these new medical techniques.” Besides Dr. Ryder, renowned international experts like Dr. Jaikak Valvaski and Prof. Raji have participated in this conference. These experts also deliberated on new techniques like articular cartilage implantation, stem cells therapy and scaffold. Dr Raju Vaishya, President of Indian Cartilage Society (ICS) said, “The problem of arthritis among the youths has become extremely alarming now because it is leading to their knee replacement.” He informed that the medical science is now blessed with new techniques in orthopedics and it is now becoming possible to save the human body’s natural joints, which have become defective, by regenerating their tissues instead of replacing them with artificial joints. “Cartilage regeneration techniques developed in recent times help in forming natural cartilage; and because of this the need for replacement of a joint is either completely eliminated or it can be delayed. In particular, such types of techniques will be beneficial for those youths whose knee or other joints have become defective because of injuries to cartilage or due to arthritis”, he pointed out. Dr. Ajay Agarwal, who is based in the US, discussed about measures to preserve hip joints in youths. In this conference, stem cell therapy also came up for deliberations.   Dr. Saurav Mathur, Organising Secretary of the conference said, “Cartilage is an extremely important cellular component of the human body. It is a strong tissue but is softer and more elastin as compared to the bones. Cartilage is formed of special cells which are called chondrolysis, and these cells produce in large quantities collagen fiber, proteoglycan, and extracellular matrix compounds made of elastic fibers.” Dr. Deepak Goyal, former President of ICS, informed that the tissues of cartilage have the potential to repair themselves, but this potential is extremely limited because it does not contain blood cells and blood is required for the healing process.  Dr. Nishith Shah, who is also a former President of ICS said, “These days several new techniques are being used for regeneration of cartilage, and researchers are trying to develop new methods for production of cartilage which can help people get rid of severe pain from osteoarthritis and enable them to live a longer life with their natural joints.” In this two-day conclave, around 200 cartilage specialists from India and foreign countries like US, Britain, Poland, Hungary, Iraq, Iran and Afghanistan have participated. Internationally acclaimed cartilage scientist Dr Bruce Ryder of US inaugurated the conclave.     ]]> https://biospectrumindia.com/news/97/12222/meril-launches-first-indigenously-developed-tavr-therapy.html https://biospectrumindia.com/news/97/12222/meril-launches-first-indigenously-developed-tavr-therapy.html Mon, 10 Dec 2018 10:00:00 +0530 Meril Life Sciences has introduced the first ever indigenously designed and manufactured Transcatheter Aortic Heart Valve (TAVR) - Myval. With this launch, Meril, a global medical devices company becomes the First Indian Company to make Transcatheter Aortic Heart Valve Replacement (TAVR) Therapy commercially available on the world stage. Transcatheter Aortic Valve Replacement (TAVR) is an established treatment modality for patients who are at a high risk or unwilling to undergo open heart valve replacement surgery. TAVR is aminimally invasive procedure in which the Doctor places a replacement valve into the patient’s native diseased valve via a catheter inserted through the femoral artery (large artery in groin). This is an alternative way to replace diseased valves without undergoing traditional open heart procedure (which some patients may not tolerate well). Commenting on the approval, Sanjeev Bhatt (Vice President-Corporate Strategy, Meril Life Sciences) said, “Meril has always been dedicated towards design and development of novel, clinically relevant, state-of-the-art and best-in-class devices to alleviate human suffering and improve quality of life. The launch of indigenously developed Myval Transcatheter Heart Valve technology is an assertion of this fundamental belief. For us, it is a proud moment to be the first Indian company to commercially make this therapy available in the country. Through the commercialization of this technology, Meril will soon bring the next generation treatment modality to thousands of patients across the country and globally. Making India proud of this achievement.” Commenting on the approval Dr. P K Minocha (Director, Research & Development, Meril Life Sciences) said,“Since its inception, Meril has played a leading role in developing and introducing innovative medical technologies. The Myval-TAVR technology has been developed after 6 years of extensive research and is backed by robust bench testing, pre-clinical and clinical data. We are committed to take this technology to over 100 countries and benefit thousands of patients across the globe." Dr. Ashok Seth, Chairman of Fortis Escorts Heart Institute, New Delhi and Head, Cardiology Council of Fortis Group of Hospitals said: As the Principal Investigator of the clinical trial of MyvalTranscatheter Aortic Heart Valve, it is heartening to note that the device has been proven to be safe and effective as required by the regulatory standards of India.  The development of this valve, which is implanted non-surgically through a catheter is also a great achievement for the ‘Made in India’ initiative that such an important R&D has happened from India in a field which till now has been dominated by only American devices.  The regulatory approval of the indigenous Myval provides genuine hope for thousands of patients with Aortic Stenosis in India and Asia, who were considered risky for surgery and can now undergo safer Transcatheter Aortic Valve Replacement through non-surgical catheter-based treatment. Dr.Samin K. Sharma (Chairman – Eternal Hospital, Jaipur, Rajasthan; Director, Clinical and Interventional Cardiology and President, Mount Sinai Heart Network, New York, USA) said: We have been performing TAVR procedures in USA for over 8 years and it’s heartening to know that Myval-TAVR is a Made in India technology, now going to be available for treatment of Indian population. As the Chairman of MyVal-1 pivotal clinical study in India, I feel excited with possibility of treating patients with aortic stenosis who are not able to have surgery or for whom surgery might be a risky decision. The Myval TAVRtechnology has been designed and developed by Meril Life Sciences, headquarteredin Vapi, Gujarat,India and has recently received approval for use by Central Drugs Standard Control Organization (CDSCO). The approval was received on the basis of successful results from a clinical trial done in India.All patients are doing well post procedure and during follow-up. This novel Myval technology is associated with Zero new pacemaker implantation rates post procedure (which is an important benefit for the patient already treated for valve replacement). Pacemaker is an additional device that may be placed post TAVR procedure. TAVR is increasingly becoming a preferred alternative for surgical valve replacement. Faster recovery time and associated clinical benefits for the patients are some of the reasons for this innovative technology’s growing adoption worldwide. ]]> https://biospectrumindia.com/news/97/12208/new-delhi-to-conduct-evidence2policy-lecture-on-cervical-cancer-.html https://biospectrumindia.com/news/97/12208/new-delhi-to-conduct-evidence2policy-lecture-on-cervical-cancer-.html Thu, 06 Dec 2018 19:10:00 +0530 The George Institute for Global Health announced its first ever Annual ‘Evidence2Policy’ lecture, which would be delivered by Prof. Ian Jacobs, Vice-Chancellor, University of New South Wales (UNSW), The lecture - “The evidence base and case for action in screening and prevention for ovarian and cervical cancers” will focus on his three decade long research in the gap between evidence and global action in cervical cancer screening and is expected to provide insights for the healthcare policies in India. Professor Jacob’s expertise in the field of Women’s Cancers and his initiatives for early detection and screening of ovarian and cervical cancers could provide insights on preventing the progression of these cancers among women. This event will also be a great starting point for UNSW Sydney and The George Institute to work together with partners in India on this topic. Evidence2policy lecture will be held on 10th December, 2018 at India Habitat Centre (New Delhi), 1 PM onwards. The Australian High Commissioner to India, Harinder Kaur Sidhu will be the Chief Guest for the occasion. Prof. Jacobs’ lecture would be followed by a panel discussion on “Women’s cancers: A Public Health Agenda”. The panel will be chaired by Dr. Preetha Rajaraman, Health Attaché and Regional representative, South Asia, US Embassy, New Delhi and the following experts in the field of Oncology and Gynecology will participate in the discussion - Sanjay Gupta - Scientist, National Institute of Cancer Prevention and Research, Neerja Bhatla, Professor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences Krithiga Shridhar, Research Scientist, Public Health Foundation of India Jyotsna Govil, Vice Chairman, Indian Cancer Society Roopa Hariprasad, Scientist, National Institute of Cancer Prevention and Research The panel is expected to discuss the screening efforts for the common cancers as part of the national programme, how women are disproportionally affected by cancers that are common to both men and women, linkages between screening initiatives and treatment options, training and capacity building of health workers in cancer screening – the learnings from the NICPR ECHO program and the potential to scale it up. Professor Jacobs expressed his delight in participating in the event and said that the role of higher education providers is to collaborate to find solutions to the problems that people face across the globe. “As Australia’s global university, UNSW is committed to improving and transforming lives through excellence in research, outstanding education and a commitment to advancing a just society.” ]]> https://biospectrumindia.com/news/97/12207/revolutionary-treatment-for-parkinsons-enters-india.html https://biospectrumindia.com/news/97/12207/revolutionary-treatment-for-parkinsons-enters-india.html Thu, 06 Dec 2018 19:00:00 +0530 Nanavati Super Speciality Hospital in association with Kings College, London launched a revolutionary treatment that will change the way Parkinson’s has been treated in India. Apomorphine Pen & Pump, the treatment that will radically change the life of a Parkinson’s patient will now be available in India. The treatment was launched in Mumbai recently by the Health Minister of Maharashtra, Dr. Deepak Sawant and Paresh Rawal, Actor and Member of Parliament. Parkinson’s disease is one of the common neurodegenerative diseases affecting the people over the age of 55 years. Parkinson’s is characterized by slowness, stiffness and tremors are a special neurodegenerative disorder with very few therapeutic options available. In India, the prevalence of this disease advances between the age of 70-79. It is caused by dopamine deficiency which is a chemical neuro transmitter in the brain mainly in the centers controlling the mobility. Apomorphine is a highly selective Dopamine receptor stimulator, which promotes the release of dopamine in the brain from the nerve cells that is otherwise absent. Dr. RajendraPatankar, COO, Nanavati Super Speciality Hospitalsaid, “Apomorphine is a revolutionary breakthrough to treat the Parkinson’s patients. Associating with the prestigious King’s College, London has been an honor for us. As a healthcare provider, we would like to commit ourselves to improve the healthcare in India and bring in such great advancements in the field on medicine to India.”  The pen and pump treatment is an effective alternative for those who do not want to undergo Deep Brain Stimulation (DBS). According to Dr. Neeta Shah, Consultant Parkinson’s Disease and Movement Disorders Specialist, Nanavati Super Specialty Hospital, said, “Parkinson’s disease in advance stage is a challenge to treat. Patient suffers from progression in symptoms and side effects of increasing dosages of standard medications. We need some novel way to treat this. This treatment will be a boon for such patients.” Speaking about the launch, Dr. Vinod Metta, Movement Disorders Specialist from London, UK, who is leading one of biggest set of patients on Apomorphine in United Kingdom, told that Apomorphine pens work dramatically with giving benefits to patients within couple of minutes and are very similar to usage that of Insulin Pens. ]]> https://biospectrumindia.com/news/97/12190/mtai-supports-cdsco-proposal-on-surgical-gowns-drapes.html https://biospectrumindia.com/news/97/12190/mtai-supports-cdsco-proposal-on-surgical-gowns-drapes.html Wed, 05 Dec 2018 14:10:00 +0530 The Central Drugs Standard Control Organization last week proposed to include surgical gowns and drapes under Drugs and Cosmetics Act, 1940 which will bring these products under the regulatory framework of the government. At present, 23 medical devices such as cardiac stents, orthopedic implants, intra-ocular lenses etc. are regulated under the said Act. CDSCO has sought stakeholders’ views on the proposal by 15th January. Medical Technology Association of India (MTaI) has welcomed the CDSCO proposal for inclusion of surgical gowns and drapes as medical devices and said it will ensure uniformity of quality in these product categories. Pavan Choudary, Chairman & Director General, MTaI said, “The inclusion of surgical gowns and drapes would ensure uniformity in the quality of products available in the market. Gowns and drapes come into direct contact of patients as well as healthcare professionals during the entire healthcare cycle, from diagnostic procedures to post-operative care. Hence, it is extremely important to ensure that only products of the highest quality are used.” “MTaI and its member companies look forward to work with CDSCO to streamline the transition to the new requirements as and when the proposal is implemented,” he added. MTaI further said that the Association will work with its member companies to ensure compliance of the regulations.     ]]> https://biospectrumindia.com/news/97/12148/researchers-develop-bandage-to-heal-damaged-tissue-of-heart.html https://biospectrumindia.com/news/97/12148/researchers-develop-bandage-to-heal-damaged-tissue-of-heart.html Thu, 29 Nov 2018 20:00:00 +0530 A new type of implantable bandage could help mend broken hearts. Each bandage is a thin film that oozes a cocktail of molecules to heal tissue damaged during a heart attack. In experiments with rats and pigs, these patches helped minimize scarring and preserve the heart’s ability to pump blood, researchers report online November 28 in Science Advances. Such devices could someday curb heart attack survivors’ risk of heart failure. The base of each heart-healing film is a polymer sheet studded with tiny needles — similar to other microneedle patches that deliver vaccines but designed to stick to a patient’s heart rather than her skin. The surface of the polymer opposite the array of microneedles is coated in a gel containing cardiac stromal cells. These cells secrete molecules, such as proteins and tiny pieces of genetic material known as microRNAs, that support the growth of heart muscle cells. “We’re treating [the patch cells] as little pharmacies,” says study coauthor Ke Cheng, a biological engineer at North Carolina State University in Raleigh. When a patch is attached to the heart, the microneedles funnel curative molecules from the cardiac stromal cells directly into the damaged tissue. In rats, Cheng’s team tested how well the microneedle patches promoted healthy tissue growth and mitigated scarring. Three weeks after researchers induced rats to have heart attacks, the animals with microneedle patches had roughly 40 percent healthy tissue in the regions of their hearts affected by the heart attack, whereas as untreated rats had only about 10 percent. For the pigs, the researchers tracked heart health by measuring how much blood was pumped from the animal’s left ventricle to the rest of its body with each heartbeat. Four hours after a heart attack, each heartbeat released about 56 to 57 percent of all the blood in the left ventricle, in both treated and untreated pigs. But 48 hours after the attack, the results began to diverge: Hearts treated with microneedle patches pumped about 60 percent of the left ventricle’s volume, while untreated hearts pumped about 50 percent.  The new microneedle design “is a very interesting and exciting” idea, but researchers need to investigate how animals implanted with these patches fare over longer periods, says Tamer Mohamed, a cardiovascular researcher at the University of Louisville in Kentucky not involved in the work. Before these microneedle patches are used to treat humans, Cheng’s team plans to swap out the polymer used in this study for a material that gradually dissolves inside the body. The researchers are also exploring less invasive ways to implant patches than open-heart surgery, Cheng says. ]]> https://biospectrumindia.com/news/97/12138/sachin-sarcoma-society-hosts-support-meet-at-core-diagnostics.html https://biospectrumindia.com/news/97/12138/sachin-sarcoma-society-hosts-support-meet-at-core-diagnostics.html Wed, 28 Nov 2018 14:10:00 +0530 With its vision to remove the fear of Sarcoma, Sachin Sarcoma Society organized their quarterly support group meeting to create awareness about a rare type of cancer called Sarcoma. The event took place in collaboration with CORE Diagnostics, a next-generation laboratory with advanced diagnostics capabilities. “The goal of the meeting was to motivate, inspire and boost the morale of other Sarcoma patients undergoing treatment and also to understand the challenges faced by them”, said the President of the Sachin Sarcoma Society, Rashi Kapoor. The event was also attended by pathologists, scientists and others from CORE Diagnostics that are often the bearers of a sarcoma diagnosis for such patients. Sarcoma usually develops from certain soft tissues, like bone or muscle and can be found in any part of the body. Lakshay Nagpal, a Parosteal Osteosarcoma survivor, was diagnosed with a tumor in his right thigh in November 2016. Narrating his story of survival, Lakshay said, “Cancer symptoms showed up six months after the pain started. He immediately took the biopsy tests that confirmed the disease. Fortunately, a timely correct diagnosis saved him from chemotherapy and radiation. After the surgery, he resumed his normal life and can walk freely without support. The Sachin Sarcoma Society hosts a number of sessions for Sarcoma patients of all age groups and their families. Through the event there were many brave souls aged between 15-80 years—patients as well as caregivers—that shared their stories with brutal honesty. Speaking on this occasion, Zoya Brar, Founder & CEO, CORE Diagnostics said, "Both the Sachin Sarcoma Society and CORE share a common mission. Our organizations are focused on things others don’t – helping bringing awareness and diagnosis to hitherto lesser known types of diseases. With this mission, we are taking one step further to sensitize the masses about Sarcoma, a rare type of cancer. Most often misdiagnosed, or diagnosed too late, Sarcoma patients are often subjected to a reality much worse than most other cancer patients. Therefore it is an urgent need to spread awareness on sarcoma. We are touched that the Sachin Sarcoma Society agreed to make us part of their mission. Most importantly, meeting such brave fighters has strengthened our resolve to continue our work on brining the most advance testing to Indian patients.”   ]]> https://biospectrumindia.com/news/97/12134/aimed-responds-to-the-recent-industry-investigation.html https://biospectrumindia.com/news/97/12134/aimed-responds-to-the-recent-industry-investigation.html Wed, 28 Nov 2018 11:25:00 +0530 Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) responded on the recent  investigation into the Indian medical devices industry which has revealed a number of serious problems, including companies lobbying and bribing doctors, and patients being duped into unnecessary operations. It has revealed some glaring loopholes in the regulatory framework that governs the medical devices industry. Global majors Medtronic and Stryker, Abbott and Bayer, all operating in a regulatory regime where there is no oversight for medical devices — either for their quality, clinical testing, pricing or performance. It has been found that from coronary stents and pacemakers to breast and knee implants, from pelvic meshes to intrauterine devices — almost every medical device is advertised, sold, surgically implanted in a regulatory system that, effectively, doesn’t exist. India’s medical device industry is estimated to be worth $5.2 billion – the fourth largest in Asia. The market at retail and institutional level is estimated to be over Rs. 10000 Cr. The number of cases of a medical device implant going wrong in a patient have increased from 40 in 2014 to 556 in 2018. Rajiv Nath responded - "It was a big shocker. Even though we were expecting bad news but when I went through the story, even I was shocked by what has been happening internationally and also in India." This year the government did introduce a separate medical device rulebook but it is still under the existing drug act which is a misfit, Nath said, adding that two years back we were promised that a separate act will be coming out but we have not seen any consultation with stakeholders on the draft that was created by the ministry of health. Did u know it’s challenging for a new start up / entrepreneur to get his medical devices used by a surgeon in India as Surgeons if unsure of quality in absence of a Quality Certification or Regulatory Approval will not even try it - understandably so. Only 23 out of over 5000 categories of devices are regulated and that also incorrectly as a Drug. Government needs to regulate all kinds of devices at one go with a defined transition period. If Govt is reluctant that it’s going to harm industry especially MSME and manufacturing may suffer then Govt needs to consider a phased in calibrated approach of initially incentivising Voluntary QA ICMED certification by QCI to enable capacity building of MSME and then in next phase pass Quality Control order under BIS Act to make certain provisions in the Medical Devices Rules mandatory for all medical devices manufacturers and imports . As ICMED is voluntary it needs to be incentivized by giving preference in public health care procurement instead of seeking USFDA & CE Regulatory approvals  which are beyond reach of a start up or most entrepreneurs. Finally we do need a separate law for medical Devices and need to initiate that ASAP as the legislative process is lengthy. Right now Govt. even does not know who makes what and how many manufacturers are there in India. Ayushman Bharat will take care of the needy 1/3 of Indian population with nil or near nil income What about the middle class ? For them to afford healthcare at reasonable costs we need regulations of Healthcare & Medical Devices and caps on Trade Markups and a strong ethical marketing watchdog. No? As an Association that encourages responsible manufactures we have consistently lobbied and requested GoI Dept for above with initial supportive response and then a confused stalemate as the Govt. conferred with the ones who are not interested in such regulations. Does India need a calibrated approach to regulations to clean up the market and address the problem of over 1000-2000% mark up being charged on medical devices? With elections coming, healthcare and affordable access is going to be a major issue and public will not be happy if the governments at Centre or at states continue to ignore the issue that’s looting the common man and harming the ethical manufacturers and forcing them to market their products unethically. Government listens to us and  is supportive initially but consults importers who don’t want loss of their share and end up confusing government into an  inaction stalemate. ]]> https://biospectrumindia.com/news/97/12132/roche-launches-first-ivd-pan-trk-assay-for-cancer.html https://biospectrumindia.com/news/97/12132/roche-launches-first-ivd-pan-trk-assay-for-cancer.html Wed, 28 Nov 2018 10:40:00 +0530 Roche has announced the global launch of the VENTANA pan-TRK (EPR17341) Assay, the first automated in vitro diagnostic (IVD) immunohistochemistry (IHC) assay to detect tropomyosin receptor kinase (TRK) proteins in cancer. With the launch, laboratories are now able to identify wild-type and chimeric fusion proteins through detection of the TRK C-terminal region. This assay can be used to perform analytic studies, including prevalence in solid tumors. While wild-type protein expression is generally low in both prevalence and intensity level, it can be substantial in some neuroendocrine tumor tissues. TRK-fusion proteins have been identified in a wide range of commonly occurring tumors, including lung, thyroid and sarcoma, at a low frequency. In some rare tumors, including infantile fibrosarcoma, secretory and juvenile breast cancer and mammary analogue secretory cancers of the salivary glands, TRK fusion proteins are likely to be the defining genetic feature. The VENTANA pan-TRK (EPR17341) Assay is available for use on Roche's BenchMark series of IHC/ISH automated staining instruments. ]]> https://biospectrumindia.com/news/97/12129/fortis-hospital-collaborates-with-philips-for-echocardiography-training.html https://biospectrumindia.com/news/97/12129/fortis-hospital-collaborates-with-philips-for-echocardiography-training.html Tue, 27 Nov 2018 17:55:00 +0530 Fortis Hospital, Bengaluru in collaboration with Philips India has launched an echocardiography training centre, focused to help doctors learn more about echocardiography. It is the second most widely used test for investigating heart diseases. With increasing incidents of heart diseases in India, echocardiography as an easily available and affordable test needs to be better utilized in various patient scenarios. Physicians are in need of trainings to better manage their patients and to also upgrade their skills in the latest methods of TBC. This specialized learning and training centre co-supported by Philips India has a training programme in echocardiography which is related to non-invasive cardiology which is an area predominantly focusing on the various investigations done for patients who have suspected or known cardiac diseases. Dr. Satish Govind, Chief of Non-Invasive Cardiology, Fortis hospitals, Bengaluru said, “This unique training centre at Fortis hospitals, Bengaluru is fully equipped with facilities that will cater to doctors, both, nationally and internationally. The centre named as ELITE (echo learning and training education centre) will focus on basic echo for the beginners or the not so-skilled practitioners and advanced echo for professionals who may want to upgrade their skills with the latest technology and learn additional echocardiography related specialized procedures.” “Reputed and experienced faculty who will personally supervise the training, will further enhance the experience of the attendees. Training in small groups with actual equipment, as also simulators and laptop aids will be done year-round, with plans to incorporate live video teaching from overseas international faculty later in the year. The well-designed interactive training modules will be short and intense with emphasis on practical aspects, which ultimately should lead to better patient care”, he added. Commenting on the partnership, a Philips India’s spokesperson commented, “Philips has been revolutionizing pathways to address health issues through innovative products and solutions. The launch of echocardiography training centre in partnership with Fortis Hospitals, will be a milestone in imparting clinical education in diagnoses of cardiovascular diseases in India. This state-of-the art centre further drives us to work towards our mission of delivering on personalized and accessible cardiovascular care.”       ]]> https://biospectrumindia.com/news/97/12080/3d-images-from-worlds-first-full-body-scanner.html https://biospectrumindia.com/news/97/12080/3d-images-from-worlds-first-full-body-scanner.html Wed, 21 Nov 2018 15:50:00 +0530 Images from the world's first full-body 3D medical scanner named EXPLORER have been released. This scanner is developed by scientists from UC Davis, the scanner combined positron emission tomography (PET) and X-ray computed tomography (CT) to capture the entire body at once. Scientists Simon Cherry and Ramsey Badawai believe the technology will have "countless applications" from improving diagnostics through to drug research and tracking disease progression. The first images of human scans from the EXPLORER are to be presented at a meeting of the Radiological Society of North America on 24 November in Chicago. "While I had imagined what the images would look like for years, nothing prepared me for the incredible detail we could see on that first scan," said Mr Cherry, distinguished professor in the UC Davis department of biomedical engineering. EXPLORER will have a profound impact on clinical research and patient care because it produces higher-quality diagnostic PET scans than have ever been possible, they said. It also scans up to 40 times faster than current PET scans and can produce a diagnostic scan of the whole body in as little as 20-30 seconds, according to the researchers. "While there is still a lot of careful analysis to do, I think we already know that EXPLORER is delivering roughly what we had promised." Mr Badawi, chief of nuclear medicine at UC Davis Health and vice-chair for research in the department of radiology, said he was dumbfounded when he saw the first images. The level of detail was astonishing, especially once we got the reconstruction method a bit more optimised," he said. "We could see features that you just don't see on regular PET scans. And the dynamic sequence showing the radiotracer moving around the body in three dimensions over time was, frankly, mind-blowing." "There is no other device that can obtain data like this in humans, so this is truly novel added.I don't think it will be long before we see at a number of EXPLORER systems around the world,” Mr Badawi added. ]]> https://biospectrumindia.com/news/97/12073/mtai-demands-one-time-hike-in-prices-of-medical-devices.html https://biospectrumindia.com/news/97/12073/mtai-demands-one-time-hike-in-prices-of-medical-devices.html Tue, 20 Nov 2018 16:35:00 +0530 Medical Technology Association of India (MTaI) released a statement saying that the government should allow a one-time increase of upto 18% in MRPs of medical devices, including stents and orthopedic knee implants, as rupee depreciation and inflation have raised their cost to companies. Rupee has depreciated 13.13% against the US dollar and 12.33% against Euro in last one year. Wholesale price inflation has hovered between 4% and 5% during this period. The current regulatory framework in India mandates price ceiling for scheduled devices like stents and orthopedic knee implants and allows only upto 10% increase in Maximum Retail Prices (MRPs) of regulated non-scheduled devices like catheters, heart valves, etc.   The government had fixed price ceiling for stents and knee implants in 2017 based on landed cost of these devices in India. The rupee depreciation has increased the landed cost by around 14%. Pavan Choudary, Chairman and Director General, MTaI said, “The dual effect of weakening of currency and inflationary trends is creating an extra-ordinary situation and the medical device companies are finding it increasingly difficult to sustain the supply of medical devices in the present situation. Long-term cross subsidization to keep the supplies is not healthy for the growing medtech sector. The present situation calls for an increase in our net realized prices.” Para 19 of Drug Price Control Order (DPCO) 2013 allows the government to revise the prices of drugs under extra-ordinary circumstances. “The government should allow a 14-18% increase in the ceiling price of all notified medical devices (including stents and knee implants) this year and not stick to the 10% ceiling on MRPs as per the DPCO 2013 given the unprecedented depreciation of the rupee and other inflationary trends”, he added   He also said, “MTaI believes unreasonably high trade margins are a major contributor to the increased MRP of medical devices. This is supported by 4 independent government reports namely, CCI- Policy Note on Affordable Healthcare (October 2018); NITI-Aayog’s Concept Note on Medical Devices (July 2018); NPPA’s report on overcharging by hospitals (February 2018) and Report of the Committee of High Trade Margin in the Sale of Drugs, 2016 (DOP Report). MTaI strongly recommends Trade Margin Rationalization from first point of sale, which is the price to the distributor, as recommended by DOP Report and as suggested by NITI Aayog’s concept note, as this could bring in affordability. It would also ensure the continued availability of medical devices and investments in capacity building in this sector, which is crucial for the success of Ayushman Bharat (PMJAY). The trade margin rationalization should replace any suboptimal regulatory instruments such as price control.”   ]]> https://biospectrumindia.com/news/97/12044/meril-life-sciences-first-to-get-approval-for-tavr-technology.html https://biospectrumindia.com/news/97/12044/meril-life-sciences-first-to-get-approval-for-tavr-technology.html Fri, 16 Nov 2018 15:30:00 +0530 Meril Life Sciences, an indigenous global medical devices company, has received approval for commercialization of Myval-TAVR technology from the Central Drugs Standard Control Organization (CDSCO). The device is the First Indigenously developed and manufactured Transcatheter Aortic Heart Valve Replacement (TAVR) technology and with this launch, Meril will become the First Indian Company in the world and the Third in India to make this technology commercially available.    Headquartered in Vapi, Gujarat, India, the company received approval for the Myval TAVR technology on the basis of successful results from clinical study done in India. All patients are doing well post procedure and during follow-up. This novel Myval technology is associated with Zero new pacemaker implantation rates post procedure (which is an important benefit for the patient already treated for valve replacement). Pacemaker is an additional device that may be placed post TAVR procedure. Commenting on the approval, Sanjeev Bhatt (Vice President-Corporate Strategy, Meril Life Sciences) said, “Meril has always been dedicated towards design and development of novel, clinically relevant, state-of-the-art and best-in-class devices to alleviate human suffering and improve quality of life. The launch of indigenously developed Myval Transcatheter Heart Valve technology is an assertion of this fundamental belief. For us, it is a proud moment to be the first Indian company to commercially make this therapy available in the country. Through the commercialization of this technology, Meril will soon bring the next generation treatment modality to thousands of patients across the country and globally. Making India proud of this achievement.”   Commenting on the approval Dr. P K Minocha (Director, Research & Development, Meril Life Sciences) said, “Since its inception, Meril has played a leading role in developing and introducing innovative medical technologies. The Myval-TAVR technology has been developed after 6 years of extensive research and is backed by robust bench testing, pre-clinical and clinical data. We are committed to take this technology to over 100 countries and benefit thousands of patients across the globe."   Transcatheter Aortic Valve Replacement (TAVR) is an established treatment modality for patients who are at a high risk or unwilling to undergo open heart valve replacement surgery. TAVR is a minimally invasive procedure in which the doctor places a replacement valve into the patient’s native diseased valve via a catheter inserted through the femoral artery (large artery in groin). This is an alternative way to replace diseased valves without undergoing traditional open heart procedure (which some patients may not tolerate well). ]]> https://biospectrumindia.com/news/97/12042/oncostem-diagnostics-receives-accreditation-from-cap-.html https://biospectrumindia.com/news/97/12042/oncostem-diagnostics-receives-accreditation-from-cap-.html Fri, 16 Nov 2018 14:40:00 +0530 OncoStem Diagnostics, an Oncology focused company that enables personalised breast cancer treatment has been awarded accreditation from the College of American Pathologists (CAP) for its laboratory in Bangalore. CAP accreditation is awarded to laboratories that meet the highest standards of quality, accuracy and consistency. The College of American Pathologists (CAP) is a leading US based organization of board-certified pathologists that serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. CAP's accredition program is widely considered the leader in laboratory quality assurance. . Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care. On the occasion, Dr Manjiri Bakre, CEO & Founder, OncoStem Diagnostics said  “We are pleased to receive this accreditation for the superior quality of laboratory services that we provide.  CAP accreditation validates our continued efforts to provide accurate results and prompt service to our patients under stringent quality processes. This recognition by CAP augments our focus on the vision to help early stage cancer patients towards optimal treatment planning through reliable and accurate results” OncoStem’s CanAssist Breast is a proteomic based test that assesses the expression of metastasis-related biomarkers to predict the probability of recurrence of invasive breast carcinoma in early stage ER+/Her2- breast cancer patients. It categorizes the risk of cancer recurrence clearly as either ‘low or high’ with no grey area in between.This clear distinction of patients based on risk of cancer recurrence allows doctors to devise treatment plans that are in tune with the prognosis, maintaining a balance between the benefits and side effects. It makes customized treatment possible by either avoiding or shortening chemotherapy treatment cycles in low-risk patients and by identifying high risk patients who would benefit from the addition of chemotherapy. ]]> https://biospectrumindia.com/news/97/12023/translumina-first-to-present-10-year-safety-data-of-des.html https://biospectrumindia.com/news/97/12023/translumina-first-to-present-10-year-safety-data-of-des.html Wed, 14 Nov 2018 15:45:00 +0530 Proving to be a major boost for the Indian medical device manufacturing industry, which is majorly dominated by US multinationals, a leading Indian producer Translumina Therapeutics LLP achieves a special feat of becoming the first company in the world to demonstrate a 10-year patient safety and efficacy data of its drug eluting stent (DES) Yukon Choice PC. This is for the first time that a decade long research data has been presented for the efficacy and safety of DES since its launch in 2001, as no other research has published data of more than 5 years. The research findings of a randomized control trial called ISAR-TEST 4 were presented by leading cardiac expert from Germany, Dr. Sebastian Kufner at the prestigious 2018 American Heart Association Scientific Sessions at Chicago, Illinois, United States, today in the presence of leading cardiologists from all over the world. “It was a privilege for me to present the first long-term data of Yukon Choice PC DES of 10 years efficacy and safety. This will not only prove the efficacy and safety of DES for long term, but also gives boost for the long-term success of the procedure of angioplasty after the launch of DES”, said Dr Sebastian Kufner, Associate Professor of Cardiology, German Heart Centre, Munich, Germany. The data demonstrated that at 10 years, both Indian made ‘Yukon Choice PC’ and much used USFDA approved ‘Xience’ stents showed significantly better results than the Cypher stent regarding major adverse cardiac events, with a risk reduction of 18% and 21% and mortality risk reduction of 18% and 22%, respectively. There were no significant differences between Yukon Choice PC and Xience stents regarding these outcomes. However, Yukon Choice PC showed the lowest rate of definite or probable stent thrombosis with a significant risk reduction than the ‘Cypher’ stent (50% reduction) and even a numerically lower rate as than the ‘Xience’ stent (29% reduction). The significance of this data has been further acknowledged by one of the most respected journals of cardiology, ‘Circulation’ that published it in its exclusive ahead-of-print online edition simultaneously.  Gurmit Singh Chugh, Managing Director, Translumina Therapeutics, who was present during the data presentation, was very excited with results and its presentation at this prestigious forum. He stated “We are excited with this first long term data which is a new milestone and a benchmark for efficacy and safety of DES Worldwide. Yukon Choice PC showing the lowest Stent thrombosis rates compared to Xience and Cypher at 10 years creates a strong testimony that this technology is truly next generation in terms of safety. Prof Adnan Kastrati, Principal Investigator of ISAR Test 4 and the Director of Cardiac Cath Lab at German Heart Centre, Munich stated “The 10-year results achieved in this trial with new-generation DES provide a strong argument against still existing concerns about the long-term safety of DES”. He elaborated that Yukon Choice PC uses a unique technology consisting in the combination of special surface modification and low polymeric load for controlled and optimal release kinetics of an anti-proliferative drug. The excellent results are a confirmation of the great and durable performance of this device. Yukon Choice PC stents are manufactured at the Dehradun facility of Translumina Therapeutics, which holds around 15 per cent share of the Rs 1,500 crore stents market in India.  The trial ISAR-TEST 4 compared Yukon Choice PC against Xience (manufactured by Abbott Vascular, USA) in 2603 patients in Germany for a follow-up period of 10 years. It is interesting to note that National Pharmaceutical Pricing Authority (NPPA) had put an upper ceiling of MRP in Feb 2017 by slashing the MRP of DES by over 70%. This move proved to be extremely beneficial for domestic manufacturers to make their high end technologies available to the hospitals at a time when multinational players were withdrawing their DES citing unaffordability. Translumina Therapeutics emerged a stronger player post price ceiling as it offered high quality and proven DES at the ceiling prices. “I wish to dedicate this success to our Prime Minister Shri Narendra Modi who created a belief about the possibility of manufacturing high-end medical devices in India. He has provided an encouraging and conducive ecosystem for the manufacturing of complex technologies in India,” said Punita Sharma, Co-Founder, Translumina Therapeutics. The DES market in the World was dominated by US multinationals for more than 15 years since the launch of DES. Most of the pivotal randomized trials of DES had a maximum follow-up for up to 5 years. With more young patients getting CAD, cardiologists from all over the world were anxious to get some insights on the long-term performance of the new generation DES in terms of efficacy and safety. “The long-term data from the ISAR-TEST 4 trial shall not only increase the confidence of Cardiologists on these new generation DES but shall also reassure patients who have received these DES for the treatment of coronary artery disease. I am pleased that one of these technologies is coming from India which shall create immense positivity and high acceptance for Indian manufactured DES world over” said Dr. Robert Byrne, Deputy Director of Cardiology at German Heart Center and Senior Author of the presented study. ]]> https://biospectrumindia.com/news/97/12011/core-diagnostics-partners-with-guardant-health-amea-.html https://biospectrumindia.com/news/97/12011/core-diagnostics-partners-with-guardant-health-amea-.html Tue, 13 Nov 2018 15:50:00 +0530 CORE Diagnostics, a next-generation startup and go-to-experts for high-end clinical diagnostics, has joined forces with Guardant Health AMEA, a leading precision oncology company to bring their comprehensive liquid biopsy, Guardant360 to India. Guardant360 detects cell-free circulating tumor DNA (ctDNA) in blood specimens of advanced solid-tumor cancer patients and evaluates 73 genes. It tests four major classes of alterations relevant for treatment selection: point mutations, indels (insertions/deletions), copy number amplifications, and fusions/rearrangements. Guardant Health’s proprietary Digital Sequencing method optimizes next generation sequencing (NGS) for accurate tumor variant detection at the low allele fractions present in cell-free DNA. High-efficiency capture enables single molecule detection, optimizing sensitivity, while unique digital barcoding and custom bioinformatics analysis optimizes specificity. Since its launch in 2014, Guardant360 has become the world's market-leading comprehensive liquid biopsy test and has been used by more than 5,000 oncologists globally, over 70,000 patients and upwards of 50 biopharmaceutical companies. It is the most widely published test with over 80 peer-reviewed publications, more than 20 clinical outcomes studies and boasts a short turn-around time of 7 days from the date of specimen receipt. On the announcement of the partnership, the Founder and CEO of CORE Diagnostics, Zoya Brar, said, “We are excited to partner with Guardant Health AMEA to bring their innovative test to India. Both the companies share a common vision to transform cancer care in India through innovation. With this partnership, we will be empowering the healthcare ecosystem with advanced diagnostic capabilities and bring hope for cancer patients in their advanced stages with just a simple blood test. The concept of liquid biopsies is relatively new and serves as an alternative option for patients who are unable to undergo invasive tumor tissue biopsies. We are thrilled to launch Guardant360 in the market soon and hope to enable more oncologists to tailor cancer treatment for advanced stage cancer patients.” “Guardant360 can help avoid costs, complications and delays of invasive biopsies through a simple blood draw. This test is meant for advanced cancers and is changing the way cancer is tracked and treated. We are thrilled to be able to offer this solution to the Indian market and ensure that hurdle of repeated tissue biopsies does not keep the physicians from having the most up-to-date information when making treatment decisions. For patients with advanced solid tumor cancers it means the ability to gather precise genomic picture of the tumor from both your primary tumor as well as metastatic sites without the risks of a tissue biopsy. Through our partnership with CORE Diagnostics we hope to transform the way cancer is treated in India by enabling physicians to offer new treatment options with our breakthrough blood test,” Divya Mehta, Head of Corporate Development, Asia, Middle East and Africa, Guardant Health AMEA. ]]> https://biospectrumindia.com/news/97/12010/vanta-bioscience-completes-expansion-into-clinical-research.html https://biospectrumindia.com/news/97/12010/vanta-bioscience-completes-expansion-into-clinical-research.html Tue, 13 Nov 2018 15:45:00 +0530 The Board of Vanta Bioscience Limited has announced completion of the process of its expansion into Clinical Research Business.  Vanta Bio Science Limited incorporated a wholly owned subsidiary under the name "Vanta Clinical Research Limited" on 12th September 2018. This subsidiary will carry out the business of clinical research.  This was announced in a Board Meeting here. S. Venkat Rao, CEO and whole time Director of Vanta Bioscience Limited shared that this is in continuation to earlier announcement to capitalise the new business opportunity in the field of Clinical Research services. This Subsidiary will carry out the business of Clinical research i.e.  bio-equivalence, bio-analytical studies, clinical trials, pharmacovigilance, medical writing etc.  Going forward, Vanta Clinical Research Limited is expected to be Company’s biggest money spinner and is expected to add Rs. 250 crores to Company’s top line by year 2024-25, through organic and inorganic means. The Company has already appointed Promotor Director to head this subsidiary.  He has more than three decades of experience in Clinical Research having set up similar facilities for some of the industry majors. The new subsidiary is likely to start contributing to top line during the last quarter of current financial year. The Board of Directors was also apprised that Company’s growth plan also included proposing to set up a full-fledged Analytical Services as a separate vertical within the Company. The Analytical Services are also expected contribute significantly to the revenues of the Company in near future. ]]> https://biospectrumindia.com/news/97/12008/smt-succeeds-in-bagging-one-more-tender-in-italy.html https://biospectrumindia.com/news/97/12008/smt-succeeds-in-bagging-one-more-tender-in-italy.html Tue, 13 Nov 2018 10:40:00 +0530 India’s leading medical device firm Sahajanand Medical Technologies (SMT) has bagged second tender through its Italian partner Eukon in Sicily region, Italy. After the scrupulous assessment of the product quality, SMT’s Supraflex stent was amongst the top 4 out of the 20 products to win the tender. The tender is to supply more than 7000 stents to 15 public hospitals in Sicily region over the next two years from the beginning of 2019. This is the second successive tender won by SMT in Italy; first tender was bagged for the Emilia Romagna region to deliver approximately 10,000 of its ‘Supraflex’ stents. SMT has successfully commercialized the Emilia tender. By qualifying for the Sicily tender SMT has successfully demonstrated its ability to compete with the best in the world for its drug-eluting coronary stents. “We have designed a strong growth plan and we are thoroughly living it!” said Gennaro Broya de Lucia, EUKON Sales Manager. "The combination of a great product like Supraflex along with an experienced and dedicated sales team has been the main driver for this market acceptance” he added. “Supraflex has proved to be a great product” he further continued, “We have seen good product appreciation from our customers and the market response has been incredible. SMT is a great partner with a responsive and structured marketing, sales and quality control team. We are proud to have partnered with SMT” Gaurav Goel, Head of Western Europe Operations, SMT explains, “Italy is one of the most rapidly growing market and we see it as an important territory to strengthen our presence in Europe. We are glad to know that the medical fraternity in appreciates our product quality. Our aim is to provide holistic 360° service to our customers starting from first contact to post sales along with continuous clinical evidence generation” Supraflex, a cardiac drug eluting stent designed and manufactured in India not only proved to be at par in safety as compared to Abbott’s Xience but also 61% better in efficacy  in an investigators-driven multicenter European randomized controlled study called 'TALENT'. The findings of the TALENT trial were presented at the 'late breaking trial session' at Transcatheter Cardiovascular Therapeutics 2018 (TCT), the largest global conference of cardiologist in San Diego, USA by a globally renowned cardiology researcher, Prof. Patrick Serruys. Supraflex has advanced features like biodegradable polymer and ultrathin strut (60µm) thickness. It is available in 65 countries across the world and is the largest selling drug eluting stent of SMT (Sahajanand Medical Technologies), India’s largest stent manufacturer. ]]> https://biospectrumindia.com/news/97/11997/aiims-researchers-design-sensitive-test-for-pulmonary-pleural-tb.html https://biospectrumindia.com/news/97/11997/aiims-researchers-design-sensitive-test-for-pulmonary-pleural-tb.html Sun, 11 Nov 2018 14:20:00 +0530 A team of researchers from the Department of Biotechnology at the All India Institutes of Medical Sciences (AIIMS), New Delhi has developed a highly sensitive diagnostic test for pulmonary and pleural tuberculosis (TB). The diagnostic test makes use of a DNA aptamer (a small single-stranded DNA molecule that binds to a specific target molecule) that shows high binding affinity to a TB antigen. The laboratory-based aptamer test for diagnosing pulmonary TB takes about five hours to turn in the results while the portable, rapid test takes just 30 minutes. Also, the portable test is cheaper and can be used for screening pulmonary TB and active case finding in high-risk groups. The research team has applied for a patent for the aptamer reagent and has licensed it to AptaBharat Innovation Pvt. Ltd, a start-up at the Translational Health Science and Technology Institute (THSTI), Faridabad. The team soon plans to validate the tests on well characterised panel of specimens and field evaluation. ]]> https://biospectrumindia.com/news/97/11974/veeda-clinical-research-has-succesfully-completed-fifth-who-inspection.html https://biospectrumindia.com/news/97/11974/veeda-clinical-research-has-succesfully-completed-fifth-who-inspection.html Mon, 05 Nov 2018 16:10:00 +0530 Veeda Clinical Research Pvt. Ltd., a leading independent CRO has announcend that its Shivalik, Insignia and Vedant (except bio analytical) facility has successfully completed fifth inspection by WHO (World Health Organization) without any critical observations. After successful inspection by NPRA (Malaysian Regulatory Agency), Veeda CRO faced another inspection in the same month by WHO. This inspection was the fifth WHO inspection at Veeda. WHO Inspectors did thorough inspection of all three Veeda facilities, wherein they reviewed various BE studies submitted as part of pre-qualification of BE-studies applications program. The Inspection team also covered various other study related activities as well as different facilities. Veeda CRO have successfully faced 50 regulatory audits in last 13 years wherein 18 USFDA Inspections were conducted successfully in last 24 months which demonstrates our commitment levels towards Quality and Regulatory Compliance. With an enhanced focus on 'Right First Time' approach, Veeda CR looks forward to a brighter future in Clinical Research Arena. These inspections are another testimony to Veeda CR's continuous quality review and improvement measures institutionalized into the work culture, the company has said in a release. ]]> https://biospectrumindia.com/news/97/11961/hmd-procures-2018-good-design-award-in-japan.html https://biospectrumindia.com/news/97/11961/hmd-procures-2018-good-design-award-in-japan.html Fri, 02 Nov 2018 15:20:00 +0530 Hindustan Syringes & Medical Devices Ltd (HMD), one of the largest manufacturers of Disposable Syringes in the World and the largest for Auto Disable syringes has been awarded the prestigious ‘2018 Good Design Award’ for HMD’s Safety IV Cannula - Cathy Sipclipearning recognition in the category of Medical Care Products at the Good Design Award 2018 hosted by the Japan Institute of Design Promotion in Japan. Japanese Good Design Award 2018 is an additional feather in the cap to the MDSAP (Medical Device Single Audit Plan)quality assurance certification from UL (Underwriters Laboratories, USA) and ICMED (Indian Certification for Medical Devices) certification HMD received from QCI (Quality Council of India). ICMED Certification process allowed us to build competencies and confidence needed to strive for MDSAP and winning the Indian Design Award from DIPP helped us in winning the prestigious Japanese Good Design (G-Mark) Award - explained Mr. Rajiv Nath, Jt. Managing Director of Hindustan Syringes & Medical Devices. HMD’s  Safety IV Cannula - Cathy SiPClip, the most revolutionary technology and patented design greatly minimizes the chances of accidental needle stick injury among health workers and nursing staff  when they attach  IV Catheter and remove the blood infected needle from a patient which results in numerous unfortunate infections and even deaths, particularly in developing countries like India. The auto protection technology of Safety I V Cannula Cathy SipClip is designed to provide Involuntary Activated Safety due to presence of a protection device SipClip which encapsulates the tip of the used needle, when introducer needle is extracted from the Catheter. Mr. Rajiv Nath, a strong advocate for preventive measure of Blood borne infections like Needle stick injury by SIP (Sharps Injury Prevention) and of Injection Safety is seeking a National Swach Injection Abhiyan. He has urged the Govt. to accelerate a switch to “Auto Disable Syringes” to limit HIV and Hepatitis Epidemic. There are villages with over half the population infected with Hepatitis or HIV due to reuse of Syringes by quacks. In order to prevent reuse of syringes and contain the spread of infection, it is advisable and recommended to use AD syringes specifically designed to prevent reuse. This reuse prevention has been strongly advocated by WHO. Similarly next highest risk is an accidental injury from a Needle Stick and unsafe blood exposure. Andhra Pradesh government has already taken a lead in this regard and has declared the State of Andhra Pradesh as Safety Injection Use State. “HMD will continue pursuing excellence in user-friendly intuitive innovative design and contribute towards our ongoing commitment of aiding access to affordable and safe healthcare for common people in India and other developing Countries” Added Mr. Rajiv Nath. The Good Design Award was founded in 1957 as the Good Design Product Selection System (or G Mark System), by the Ministry of International Trade and Industry (the current Ministry of Economy, Trade and Industry). It is the only system in Japan to comprehensively evaluate and recommend design and the G-Mark carries substantial International Prestige. ]]> https://biospectrumindia.com/news/97/11942/telerad-tech-launches-ai-product-for-early-stage-breast-cancer-detection.html https://biospectrumindia.com/news/97/11942/telerad-tech-launches-ai-product-for-early-stage-breast-cancer-detection.html Tue, 30 Oct 2018 17:35:00 +0530 Telerad Tech, a global healthcare technology company headquartered in Bengaluru, has announced the launch of a new AI-Powered product – MammoAssist to detect early-stage breast cancer as a Make in India Initiative. MammoAssist analyzes a mammogram and processes the imaging data to recognize radiologic features of early stage breast cancer and categorizes it for BIRADS Scoring with a full-fledged structured template. This template is then made available to a radiologist who corroborates/validates the mammography findings and issues the official report. As per the Ministry of Health and Family Welfare (MoHFW), breast cancer ranks as number one cancer among Indian females with an incidence of 25.8 per 100,000 women with 50% survival rate. The primary reason of mortality is late detection. In urban areas, 1 in 22 women is likely to develop breast cancer during their lifetimes as compared to rural areas where 1 in 60 women is likely to develop the disease. Governments in India and globally are under huge pressure to improve this situation in a cost-effective manner. MammoAssist is a cost-effective solution to the above growing problem as it acts as a catalyst for radiologist to review mammograms in minimal time. It can reduce the costs of mass screening programs.  “In breast cancer, early detection is of paramount importance in terms of improving patient outcome and reducing healthcare costs. Today, in India, most breast cancer cases are unfortunately diagnosed at a late stage, in part due to the shortage of radiologists required for interpretation of mammograms for the early detection of breast cancer. The availability of an Artificial Intelligence solution such as MammoAssist has the potential to be a game changer in terms of assisting radiologists and facilitating early detection of breast cancer,” explains Dr. Arjun Kalyanpur, Founder & Chief Radiologist of Teleradiology Solutions & Telerad Tech. “MammoAssist can play a significant role in breast cancer screening programs to eliminate negative cases with high degree of accuracy and categorizing benign and malignant cases with fully structured report with BIRADS Score in multiple languages. Our studies have shown that MammoAssist can improve the efficiency and productivity of a radiologist by more than 50%. We are highly committed to improve the patient care through artificial intelligence and deep learning in the clinical environment and are targeting to release more than 40 algorithms for radiology diagnosis by 2019” says Prashant Akhawat, COO of Telerad Tech. MammoAssist can help in early stage breast cancer detection and generate a detailed report with all significant radiologic findings such as Microcalcification, Macrocalcification, Clustered Calcification, Lesions & Lymph Node, Architectural Distortion, Bilateral Asymmetry, Breast Parenchymal Composition, Size, Shape, Location and Density analysis with BI-RADS (Breast Imaging Reporting and Data System) score. It enhances the ability of a radiologist to report cases with high accuracy and efficiency and provides a standard interface to communicate with healthcare systems like RIS-PACS, EMRs through industry standard API and protocols. MammoAssist can generate reports in multiple languages including English, Spanish, German, French, Italian, Polish, and Portuguese.    MammoAssist powers Telerad Tech’s Next Generation AI Enabled RIS-PACS Platform RADSpa. RADSpa is deployed in more than 25 countries and has been used to process more than 20 million studies. RADSpa is FDA approved and CE certified. ]]> https://biospectrumindia.com/news/97/11921/medgenome-takes-over-centre-for-genetic-health-care-.html https://biospectrumindia.com/news/97/11921/medgenome-takes-over-centre-for-genetic-health-care-.html Sun, 28 Oct 2018 12:50:00 +0530 MedGenome, India's premier genomics based research and diagnostics company, has announced that as part of its growth plans, it has taken over the management and operations of the Centre For Genetic Health Care (CGHC) in Mumbai. It will henceforth be called MedGenome- Centre For Genetic Health Care (CGHC). CGHC, a leading genetic centre, accredited by NABL and CAP and offering cytogenetic and FISH tests in pediatrics, prenatal, reproductive genetics and haematological oncology segments, has been at the forefront for providing Genetic counselling services. With this take over, it will be able to provide patients with a wide range of molecular tests across all the specialties like Reproductive, Neurology, Nephrology, Oncology, Cardiology, ENT, Endocrinology, Ophthalmology, rare diseases etc.  This will empower clinicians with validated and actionable clinical information to make effective treatment decisions for their patients. This will also bring a lot of synergy providing a unique opportunity for doctors and patient to leverage each other strengths. MedGenome-CGHC will now have cross functional team comprising of experienced medical geneticists, scientists and bioinformatics etc, who can leverage knowledge and depth on patient scenarios with large amount of curated content for enhanced reporting. The centre will boast of a larger pool of genetic counselors with enhanced depth and experience across multiple therapy areas, latest techniques for testing such as Next generation sequencing (NGS) technology and access to internationally accredited laboratory with the College of American Pathologists (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL). Speaking about the centre Dr. Hema Purandarey, Founder, CGHC said, “Genetics plays an important role in clinical practice right from prevention of genetic disorders by screening, diagnosis and management. About 60% of pregnancy losses, 2-3% of all neonate and 50% of childhood deafness, blindness, mental retardation and 1 to 10% of all malignancies are directly due to genetic factors. We are glad to associate with MedGenome to offer the most advanced molecular genetic tests that help screen, diagnose and manage such genetic disorders.” Unfortunately, many have the misconception that genetic diseases affect only a small portion of a population hence isn’t regarded as a problem. However, the reality is that, India with its high population, diverse cultural, religious and social backgrounds coupled with high birth rates and practice of consanguineous marriages in certain regions carries a heavy burden of genetic disorders. Almost 500,000 cases of children are born with genetic disorders every year and various studies suggest that chromosomal abnormalities occur with a frequency of 1 in 166 births in India. There is also a high incidence rate of Down syndrome (trisomy of chromosome number 21) with 1 in 800 births. These statistics are alarming. Genetic screening coupled with genetic counselling is hence the need of the hour that can identify at risk cases to make informed decisions about further testing. Genetic Disorders can present in any stage of life – fetal to adulthood and most of them are preventable. “We are keen on expanding our reach and serving more patients. With CGHC now being managed and operated by MedGenome, it will add many clinical tests especially in the prenatal segment (Karyotyping, FISH tests etc) to our growing test list and we would be able to offer more comprehensive solutions to the clinicians. Genetic testing today has eased the process of diagnosing the disease for the clinicians, thus reducing the trial and error methods. This has indeed augmented the quality of life and care. With increase in awareness and government intervention, genetic tests can be made accessible and affordable to maximize the benefit for all”, said Dr. VL Ramprasad, COO, MedGenome. ]]> https://biospectrumindia.com/news/97/11905/siemens-healthineers-to-develop-phone-based-urine-test-kits.html https://biospectrumindia.com/news/97/11905/siemens-healthineers-to-develop-phone-based-urine-test-kits.html Wed, 24 Oct 2018 13:00:00 +0530 Siemens Healthineers has teamed up with Israeli start-up Healthy.io to allow patients to test their urine at home by using a smartphone camera that scans a dipstick and sends the results to their doctor. The alliance is the latest partnership between medtech firms and technology companies aimed at helping patients monitor their own health, as well as lowering the costs of managing chronic diseases. Urine testing is the world’s second-most frequently conducted diagnostic test. Regular testing is needed to monitor kidney function in patients with chronic kidney disease, as well as to detect potential signs of diabetes. Under the global partnership, Healthy.io will use urinalysis tests from Siemens Healthineers in dipkits that are sent to patients at home. Patients urinate on the dipstick and scan it using their smartphone camera, which uses computer vision and machine learning to ensure the results can be read. The results are then sent via an app to the patient’s medical record for a doctor to assess. The home test kits could help doctors manage the health of diabetes patients and pregnant women that may be reluctant to travel to clinics. A number of technology companies including Apple, Samsung Electronics and Google are working on health-related applications for wearable devices and smartphones. ]]> https://biospectrumindia.com/news/97/11886/veeda-clinical-research-completes-second-audit-by-npra.html https://biospectrumindia.com/news/97/11886/veeda-clinical-research-completes-second-audit-by-npra.html Sat, 20 Oct 2018 15:05:00 +0530 Veeda Clinical Research Pvt. Ltd., a leading independent CRO has announced that its clinical (Shivalik, Ahmedabad) and Bio analytical facilities (Insignia, Ahmedabad) successfully completed second audit by NPRA (Malaysian Regulatory agency) without any major or critical observations. This Inspection was a routine study Inspection performed by the NPRA Inspectors with the purpose to verify the compliance of the facility and study conduct to the principles of Good Clinical Practices. The audit outcome confirmed that the activities in Veeda CRO are in compliance with the SOPs and regulatory guidelines. Veeda CRO have successfully faced 50 regulatory audits in last 13 years wherein 18 USFDA Inspections were conducted successfully in last 24 months which demonstrates our commitment levels towards Quality and Regulatory Compliance. With an enhanced focus on 'Right First Time' approach, Veeda CR looks forward to a brighter future in Clinical Research Arena. These inspections are another testimony to Veeda CR's continuous quality review and improvement measures institutionalized into the work culture.   ]]> https://biospectrumindia.com/news/97/11883/trivitronslabsystems-diagnostics-expands-its-portfolio-in-newborn-screening.html https://biospectrumindia.com/news/97/11883/trivitronslabsystems-diagnostics-expands-its-portfolio-in-newborn-screening.html Fri, 19 Oct 2018 15:30:00 +0530 Trivitron’sLabsystems Diagnostics Oy, a leading brand that develops and manufactures high-quality diagnostic tests for clinical laboratories and physicians, has now expanded its portfolio on advancing newborn screening (NBS) by launching six new high-quality NBS products at ISNS 2018, Slovakia (from October 14 to October 17, 2018). With this introduction, the brand continues its journey to become world’s leading service provider in the field of Newborn Screening.   Speaking on new launches, Mr. Sameer Saral, Chief Operating Officer – Labsystems Diagnostics -A Trivitron Enterprise said, “As one of the largest provider for Newborn Screening Products in the world, we are happy to introduce new high-quality NBS products under our ambit on a regular basis. The NBS procedures has evolved from a simple blood screening test to a more comprehensive and expanded screening system which is capable of detecting over 50 different conditions.”   The new NBS Products are: 1. Neomass AAAC Plus kit– Expanded newborn screening panel for quantitative determination of 15 Amino acids, free Carnitines, 12 Acylcarnitines, Argininosuccinic acid (ASA) and Succinylacetone (SUAC) under the same extraction method and single injection/single run step without using any toxic compounds, on Tandem MS.   2. CAH MASS Second Tier test kit– First to have an assay which measures 17-Hydroxyprogesterone, Androstenedione, Cortisol, 11-Deoxycortisol and 21-Deoxycortisol in dried blood spots samples. CAH-Mass LC-MS/MS quantitative kit is a second tier test for detecting congenital adrenal hyperplasia, and can be used as a confirmatory diagnostic test for CAH.   3. SCID-SMA Multiplex PCR kit - Intended for the rapid and simultaneous detection of severe combined immunodeficiency (SCID) syndrome and Spinal muscular atrophy (SMA) in newborns by using DNA samples either from whole blood or dried blood spots, after DNA extraction.   4. NS496 Plus DBS Puncher - The NS496 Plus DBS puncher with Air humidification system and clean punch mechanism designed to automate laboratory sample preparation and is used to punch dried blood spots samples into a 96 wells microtitre plates for subsequent analysis.   5. Neonatal T4 FEIA kit – Fluorescence-based NBS kit indented for the screening of congenital hypothyroidism (CH) by the quantitative determination of total Thyroxine (T4) from dried blood spots, providing further flexibility to detect congenital hypothyroidism.    6. Neonatal GALT Kit – Fluorescence-based NBS kit indented for the screening of Classic Galactosemia by the quantitative determination of galactose-1-phosphate uridyl transferase (GALT) from dried blood spots providing additional information to detect classic galactosemia. ]]> https://biospectrumindia.com/news/97/11874/trivitron-launches-high-quality-products-in-newborn-screening-panel.html https://biospectrumindia.com/news/97/11874/trivitron-launches-high-quality-products-in-newborn-screening-panel.html Wed, 17 Oct 2018 16:40:00 +0530 Trivitron’s Labsystems Diagnostics Oy, a leading brand that develops and manufactures high quality diagnostic tests for clinical laboratories and physicians, has now expanded its portfolio on advancing newborn screening (NBS) by launching six new high quality NBS products at ISNS 2018, Slovakia (from October 14 to October 17, 2018). With this introduction, the brand continues its journey to become world’s leading service provider in the field of Newborn Screening. Speaking on new launches, Sameer Saral, Chief Operating Officer – Labsystems Diagnostics (A Trivitron Enterprise) said, “As one of the largest provider for Newborn Screening Products in the world, we are happy to introduce new high quality NBS products under our ambit on a regular basis. The NBS procedures has evolved from a simple blood screening test to a more comprehensive and expanded screening system which is capable of detecting over 50 different conditions. The new NBS Products: Neomass AAAC Plus kit– Expanded newborn screening panel for quantitative determination of 15 Amino acids, free Carnitines, 12 Acylcarnitines, Argininosuccinic acid (ASA) and Succinylacetone (SUAC) under the same extraction method and single injection/single run step without using any toxic compounds, on Tandem MS. CAH MASS Second Tier test kit– First to have an assay which measures 17-Hydroxyprogesterone, Androstenedione, Cortisol, 11-Deoxycortisol and 21-Deoxycortisol in dried blood spots samples. CAH-Mass LC-MS/MS quantitative kit is a second tier test for detecting congenital adrenal hyperplasia, and can be used as a confirmatory diagnostic test for CAH. SCID-SMA Multiplex PCR kit - Intended for the rapid and simultaneous detection of severe combined immunodeficiency (SCID) syndrome and Spinal muscular atrophy (SMA) in newborns by using DNA samples either from whole blood or dried blood spots, after DNA extraction. NS496 Plus DBS Puncher - The NS496 Plus DBS puncher with Air humidification system and clean punch mechanism designed to automate laboratory sample preparation and is used to punch dried blood spots samples into a 96 wells microtitre plates for subsequent analysis. Neonatal T4 FEIA kit – Fluorescence based NBS kit indented for screening of congenital hypothyroidism (CH) by the quantitative determination of total Thyroxine (T4) from dried blood spots, providing further flexibility to detect congenital hypothyroidism. Neonatal GALT Kit – Fluorescence based NBS kit indented for screening of Classic Galactosemia by the quantitative determination of galactose-1-phosphate uridyl transferase (GALT) from dried blood spots providing additional information to detect classic galactosemia. ]]> https://biospectrumindia.com/news/97/11854/india-korea-ink-mou-to-promote-medical-devices-sector.html https://biospectrumindia.com/news/97/11854/india-korea-ink-mou-to-promote-medical-devices-sector.html Mon, 15 Oct 2018 12:50:00 +0530 In a bid to further provide an impetus and boost Indian & Korean Medical Device Industry, The Association of Indian Medical Device Industry (AiMeD) has inked a memorandum of understanding (MoU) with BUSAN TECHNOPARK from Republic of Korea to jointly work to promote medical devices industry in both the countries. The agreement was signed by Rajiv Nath, Forum Coordinator, AiMeD and Soo-Hoo Shin Chief of Healthcare Technique Division from BUSAN TECHNOPARK. The objective of the MoU signed between the two Countries is to promote the development of business relation between India and Republic of Korea, promoting bilateral trade, investment in both countries and the development and exchange of technology. Additionally, to encourage and promote participation from both the countries at various business platforms created by Indian Medical Devices Industry Association and BUSAN TECHNOPARK.  Through this cooperation AiMeD and Busan Technopark will provide assistance for visiting delegations, comprising of officials and businessman, on both side with a view to promote their business missions and facilitate business collaborations..AiMeD will also offer business-to-business match making with regard to promotion of technology and investment tie-ups to companies based in Republic of Korea. Similarly, Busan Technopark will assist AiMeD Members in their business endeavours. “The medical devices sector is being seen as the next big thing after IT and Defence sectors and India has the potential to emerge as a major manufacturer and exporter on the lines of pharma products. The government has undertaken several measures to promote its ambitious ‘Make in India’ mission in Medical Devices. The MoU between AiMeD and BUSAN TECHNOPARK is in line with realising these national objectives,” Nath said.   ]]> https://biospectrumindia.com/news/97/11853/concept-medical-raises-60m-for-innovative-sirolimus-coated-balloon.html https://biospectrumindia.com/news/97/11853/concept-medical-raises-60m-for-innovative-sirolimus-coated-balloon.html Mon, 15 Oct 2018 11:20:00 +0530 Concept Medical Inc. raises $60 million for Investigational Device Exemption (IDE) for the world's first sirolimus-coated balloon. Sirolimus balloon catheter is a drug-coated balloon, which is a replacement of the stent. If a stent cannot be placed in a human body or doesn't have a good outcome, then sirolimus balloon is used. Concept Medical Inc. (CMI) has approached the FDA for an Investigational Device Exemption (IDE) for their Sirolimus-Coated Balloon (DCB). To support this process, they have raised $60mn (for an undisclosed valuation) from cardiologist and serial entrepreneur Dr. Kiran Patel. An IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data. The funds will also be utilized to augment clinical data and clinical registries to qualify for reimbursement in the European markets, where the Company has commercially launched the product. CMI, headquartered in Florida, has a manufacturing subsidiary in India, by the name, Envision Scientific Pvt. Ltd. (ESPL), where all their products are made. A portion of the funds will also be utilized to bolster the manufacturing operations to meet the increasing demand for their products globally. Their global distribution and marketing network are operated from offices in India, Singapore, Netherlands and Brazil. ESPL also has an India-focused, marketing and distribution business. The Companies (CMI and ESPL), which were established about 10 years ago, have developed innovative and disruptive platform technologies in drug-delivery systems to address the unmet medical needs in interventional cardiology. They have 96 patents granted (another 40 under process) around the world in major markets like USA, China, Japan, Europe, India, Australia and others. They have, since, successfully commercialized globally, their first product, "Abluminus-DES coronary stent", using their proprietary drug delivery and coating systems. "MagicTouch-DEB" (sirolimus-coated balloon with application in coronary and peripheral artery disease), is commercially sold in many European countries including the UK and other countries like South Africa, Mexico, Malaysia, Indonesia, Singapore, MENA region. Extended applications of "MagicTouch-DEB" in Renal transplant, Erectile dysfunction, and AVF/AVG for Renal dialysis patients are under on-going clinical trials. CMI raised the funds from the family office of 'Dr. Kiran and Pallavi Patel'. With the fresh infusion of funds, both CMI and ESPL aim to bolster their operations in the existing and new markets. ]]> https://biospectrumindia.com/news/97/11848/medgenome-launches-genetic-test-for-chronic-lymphocytic-leukemia.html https://biospectrumindia.com/news/97/11848/medgenome-launches-genetic-test-for-chronic-lymphocytic-leukemia.html Fri, 12 Oct 2018 18:20:00 +0530 An estimated one million cases of chronic lymphocytic leukemia (CLL) are diagnosed in India every year. Chronic lymphocytic leukemia is a common type of leukemia (Blood Cancer) found in adults.  Often, CLL is accidentally discovered, with 60% patients being asymptomatic at time of presentation, where “watchful waiting” has been the standard of care aiming to minimize toxicity for the minority of patients whose disease may never evoke clinical symptoms. However, treatment is initiated when the patients progress to intermediate and high-risk symptoms that happens in nearly 50% of CLL patients. Clinical signs include- increasing number of white blood cells, anaemia or symptoms of weight loss, chronic weakness, fever, or night sweats. In these cases, chronic lymphocytic leukaemia may take an aggressive course and for this reason treatment is sought out taking into consideration several clinical and pathological and genetic testing for the personalized management of the disease. To enable prediction of the clinical course of the CLL, MedGenome, India’s premier genomics based research and diagnostics company, has announced the launch of the IGHV gene mutation testing. Current guidelines for CLL management involves comprehensive molecular work-up that includes some genetic tests performed on the patients’ blood or bone marrow sample, that enables oncologists to assess the prognosis of the disease subtype and further management of the disease by personalized therapy. Four important biomarker testing includes somatic hyper mutations (SHM) of the immunoglobulin heavy chain variable region genes (IGHV), and somatic mutations of genes such as TP53, NOTCH1, and SF3B1. Based on the SHM value, the disease is classified Mutated CLL (M-CLL) and Unmutated CLL (U-CLL). The status of SHM has clear influence on the median survival of CLL patients. Presence of SHM of the IGHV region is strongly predictive of a good prognosis, while lack of SHM predicts a poorer prognosis. Patients with an unmutated IGHV gene usually have a more aggressive disease and shorter overall survival. Patients with a mutated IGHV gene usually have a less aggressive disease, with longer overall survival. “As the therapeutic landscape for chronic lymphocytic leukaemia (CLL) continues to expand, biological predictors of response to therapy are becoming increasingly important. One such predictive biomarker is the mutational status of the variable region of the immunoglobulin heavy chain (IGHV) gene, which is a powerful predictor of duration of response. Through IGHV gene mutation testing, better understanding of the patient’s risk of disease progression at diagnosis can guide counselling and follow-up intervals, and could potentially influence the decision to treat high-risk patients on early intervention protocols.” said Dr VL Ramprasad, COO, MedGenome. ]]> https://biospectrumindia.com/news/97/11810/lifecell-launches-transformational-newborn-screening-program.html https://biospectrumindia.com/news/97/11810/lifecell-launches-transformational-newborn-screening-program.html Tue, 09 Oct 2018 16:45:00 +0530 LifeCell International, India’s premier stem cell bank and mother & baby diagnostics company today announced the launch of “RightStart” - the world’s first Integrated DNA testing for Newborn Screening to detect over 50 medical conditions. This technology has been proven to be more accurate than current screening methods and has also been found to drastically reduce the false-positive reporting thereby avoiding unnecessary follow-up tests and anxiety of the parents. In current process of newborn screening, a few drops of blood are obtained through heel prick from the baby’s heel, usually 48 hours after childbirth, and is analysed by profiling a specific set of metabolites present in the blood. If an abnormal metabolic profile is found further testing is recommended for confirmation. The confirmatory test would need an additional sample to be taken once again from the child. Since most routine screening labs do not have DNA testing capabilities, the child is referred to specialised labs leading to further delays in diagnosis & treatment apart from causing further agony for the parents. The DNA based test is considered a gold standard and is most reliable for confirmation as it does not get impacted by interferences such as medications, nutrition, temperature, or preterm status. LifeCell’s “RightStart” Newborn screening, which adopts an integrated DNA testing approach, does not require an additional sample since a portion of the sample collected initially can be used. Also, no additional costs would need to be incurred by the parents. “RightStart” provides more accurate results and also saves time & effort enabling a speedy diagnosis to initiate treatment. More importantly, the parents are alerted to the risk only if the DNA tests are positive thereby reducing parental anxiety. Ishaan Khanna, CEO of Diagnostic & BioBank Divisions, LifeCell International said “As a leader, we always bring the first and best to the country and “RightStart” is another milestone achievement. For the first time, over 50 conditions can be tested with ‘RightStart’s integrated DNA testing in the country with a faster throughput and higher accuracy of test results”. Citing an example of a condition called Congenital Adrenal Hyperplasia (CAH) it was observed that less than 10% of alarms raised with current screening technologies are finally confirmed as being truly being affected by the condition with DNA testing. Hence with DNA testing, the predictive power increases to 100%1, thereby eliminating any false alarms. Commenting on the launch of RightStart Dr Vrajesh Udani, Consultant in Child Neurology and Epilepsy, Hinduja Hospital & Saifee Hospital, Mumbai said “RightStart is an initiative by LifeCell where a positive report on newborn screening is automatically subjected to a confirmatory test. This will eliminate false positives, which is very welcome. False positive reports in newborn screening cause unwanted concerns and sometimes unwarranted treatments. I’m happy RightStart will help to reduce such false alarms” Dr Uday Pai, Paediatrician & Neonatologist, Former President, Indian Academy of Paediatrics (IAP) added, “Launch of RightStart is a welcome initiative by LifeCell and I’m sure this will surely help in better accuracy of results with integrated DNA testing and also drastically reduce the parental anxiety and delays arising due to false positives” With LifeCell launching the new RightStart Newborn Screening program the laboratory facility at Chennai has been upgraded with complete capabilities to perform these specialized DNA testing in-house. LifeCell anticipates a substantial increase in the adoption of the RightStart Newborn Screening and is collaborating with PerkinElmer, a global market leader in newborn screening. LifeCell will use PerkinElmer’s fully automated and high throughput analyser - the Genetic Screening Processor® (GSP) instrument, a first by a commercial lab in India. Also as another first-in-India, LifeCell will incorporate PerkinElmer’s next generation NeoBase™ 2 non-derivatized MS MS kit, which can screen for all the common amino acid, organic acid and fatty acid oxidation, as well as purine and peroxisomal metabolic disorders – more than any other commercial kit available in the market today. Further LifeCell had tied up with Dr Mary Seeterlin, who has a decade of experience in newborn screening program at the Department of Public Health in Michigan and is the co-author of several guidelines and publications on the subject, as a consultant to the program. “LifeCell’s mission is to improve outcomes for newborns in India, giving them the best start at birth. Towards that goal, we’ve made a major step forward by bringing in the world’s best partners, equipment, consumables, advisors, and testing programs. This centre-for-excellence will help bring together the power of metabolomics and genomics platforms to provide a holistic approach towards screening of rare disorders” said Mayur Abhaya, Managing Director, LifeCell International. India is the world’s largest birthing country with over 25 million births a year and is, unfortunately, having the highest number of infant mortality ratio too. A large number of these deaths can be prevented by screening newborns at birth for a variety of inborn genetic and metabolic disorders, even before the symptoms start showing up so that they can be managed at an early stage to reduce or even eliminate the burden of disease”. Globally millions of babies are screened through nationwide programs in over 60 countries every year. However, in India, the adoption of newborn screening has been weak largely due to low awareness and also due to the lack of reliability of the test results. ]]> https://biospectrumindia.com/news/97/11806/wipro-ge-healthcare-strengthens-its-commitment-to-india.html https://biospectrumindia.com/news/97/11806/wipro-ge-healthcare-strengthens-its-commitment-to-india.html Mon, 08 Oct 2018 14:05:00 +0530 Wipro GE Healthcare (WGE), India’s leading medical technology company has announced a series of partnerships to strengthen its commitment to healthcare in India. MoU with Society for Applied Microwave Electronics Engineering and Research (SAMEER) for the development of an Indigenous 1.5T MRI system GE Healthcare and SAMEER (an R&D unit under Department of Electronics and Information Technology (DeitY), Govt of India) will collaborate on research, design and development of a MRI Platform to include whole-body MRI, portable MRI and digital, to increase access to MRI technology in India. GE Healthcare has provided a magnet (one of the most critical components) around which a prototype is being designed. GE Healthcare will also provide SAMEER training on MRI technology and support the benchmarking of various subsystems, including gradient & radiofrequency amplifiers, coils, spectrometer and imaging software. The two partners will also collaborate to develop AI and machine learning based solutions. Commenting on the partnership, Kieran Murphy, President and CEO, GE Healthcare said, “GE Healthcare has decades of know-how on MRI technology which is one of the most advanced and complex form of medical imaging. We are delighted to share this expertise, and partner with SAMEER in this exciting journey that will significantly enhance India’s capability and competitiveness in the field of medical technology. This program is strongly aligned with the Government’s vision to boost research and ‘Make in India’, and will support Ayushman Bharat through availability of cutting-edge, yet affordable MRI technology.” This program is part of Scan Era - a national mission program launched by Department of Electronics and Information Technology (DeitY), Govt of India for indigenous development of MRI. The program is funded by the Government of India under the Hon. Prime Minister’s ‘Digital India’ initiative and SAMEER has received a first-round funding of $6.5 million to build the first prototype. Kickstarts MR localization in India to meet local demand GE Healthcare, a pioneer in medical technology started manufacturing in India in 1990. Today, many high-end subsystems such as X-ray tubes, high voltage generators, MR Amplifiers, power supplies and coils are manufactured in GE Healthcare’s three plants in India. India is also a CoE for MR electronics and high voltage generators for X-ray tubes. Leveraging these capabilities, GEHC will start to assemble, and test fully finished MR cabinets fitted with power supplies and gradient amplifiers which are made in India. Skilling partnership with Healthcare Sector Skills Council (HSSC) Skilling is a critical part of any sustainable healthcare system. Availability of skilled resources will also be critical to the success of the Ayushman Bharat program. This partnership will empower women by training 5000 community health workers and will be accelerating our ongoing skill creation initiative by training 3000 underprivileged young people in 2019. It will also help strengthen the HSSC partner network through use of GE Healthcare’s digital learning technologies. ]]> https://biospectrumindia.com/news/97/11805/strand-acquires-india-diagnostics-biz-from-quest.html https://biospectrumindia.com/news/97/11805/strand-acquires-india-diagnostics-biz-from-quest.html Mon, 08 Oct 2018 13:20:00 +0530 Strand Life Sciences, a Bangalore-based specialized research and  diagnostics company has announced an agreement to acquire the India medical diagnostics business of Quest Diagnostics, the world's leading provider of diagnostic information services.  “This acquisition is an important addition to our network of 24 diagnostic labs across India, especially as we continue to expand our work in oncology, genomics, and precision medicine. It adds strong North India presence and marquee clientele that includes leading hospital chains, corporates and pharmaceutical clients to our portfolio, making us India’s leading specialized diagnostics company”, said Dr. Ramesh Hariharan, Chief Executive Officer, Strand Life Sciences. Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics, commented: “We have built a diagnostic laboratory in India with a reputation for quality over the past 10 years. As our business model has evolved, we believe Strand Life Sciences is well positioned to continue the important work of empowering the people of India to improve their health with diagnostic insights.” The two companies will work together to manage the transition, and aim to close the sale by the end of first quarter 2019. Terms of this transaction were not disclosed. ]]> https://biospectrumindia.com/news/97/11802/fujifilm-introduces-new-endoscopy-product.html https://biospectrumindia.com/news/97/11802/fujifilm-introduces-new-endoscopy-product.html Sun, 07 Oct 2018 13:00:00 +0530 Fujifilm India Private Limited, one of the leaders in diagnostic imaging and information systems for healthcare facilities, has announced its launch of ELUXEO 7000 Series - a range of novel image-enhanced endoscopy products which have Blue Light Imaging (BLI) / Linked Color Imaging (LCI) technology to help aid early detection of all types of Gastro cancers. The move will help the company to strengthen its foothold in the medical business in India. Stomach cancer is the second-most common cancer among men and third-most among females in Asia. The symptoms and sign of the stomach cancer are often reported late when the disease is already in advanced stages, and 5-year survival rate is less than 30% in developed countries and around 20% in developing countries. Taking cognizance of this, Fujifilm India Pvt. Ltd. today introduced ELUXEO 7000 Series to increase the survival rates by early detection of gastrointestinal (GI) cancer. Commenting on the occasion, Haruto Iwata, Managing Director, Fujifilm India Pvt. Ltd. said, “At Fujifilm, our endeavour is to offer peace of mind to patients and ease their burden during difficult times by aiding in the early detection and treatment of disease. We have considerable experience in promoting screening for breast cancer through our Full Field Digital Mammography, lung cancer through our X-ray, and remote diagnosis through our PACS (Picture Archiving and Communication System) connecting various modalities and medical institutions. With the launch of our new state-of-the-art ELUXEO 7000 Series, we want to help detect GI cancer well in advance, thereby enabling patients to take preventive actions early.” “Our knowledge of the medical field stands out in our technology. Its value born from listening to the needs of healthcare professionals. We deliver confidence through our insistence of high quality which is imbibed in all our products. With the introduction of the new endoscopy business with ELUXEO 7000 Series, we feel extremely proud as it further strengthens our contribution to the quality healthcare for the Indian community through our innovative technologies. We are expecting to add 10% revenue in the overall medical business through the Endoscopy segment. We will continue to provide our clinically proven products and technologies to provide total healthcare solution to help medical professionals perform more effectively and efficiently for the improved medical service for the patients,” Mr. Iwata added. Chander Shekhar Sibal, Executive Vice President, Medical Division- Fujifilm India added, “Early detection is the key to success in any kind of cancer. If it is detected early at first or second stage then patient can be treated with more chances of positive results. Early detection increases the life span of the patient. If cancer is detected at third or fourth stage then the treatment becomes more difficult with less chances of survival. In India the major problem is late detection of cancer. More than 50 per cent of the patients die within one year of detection in India. The ELUXEO 7000 is targeted for biopsy and early alarm by helping obtain high resolution images to detect cancers at very early stage. We have a range of systems to detect cancers at early stage.” ]]> https://biospectrumindia.com/news/97/11799/lifecell-launches-transformational-newborn-screening-program.html https://biospectrumindia.com/news/97/11799/lifecell-launches-transformational-newborn-screening-program.html Fri, 05 Oct 2018 15:40:00 +0530 LifeCell International, India’s premier stem cell bank and mother & baby diagnostics company has announced the launch of “RightStart” - the world’s first Integrated DNA testing for Newborn Screening to detect over 50 medical conditions. This technology has been proven to be more accurate than current screening methods and has also been found to drastically reduce the false-positive reporting thereby avoiding unnecessary follow-up tests and anxiety of the parents. In current process of newborn screening, a few drops of blood are obtained through heel prick from the baby’s heel, usually 48 hours after childbirth, and is analysed by profiling a specific set of metabolites present in the blood. If an abnormal metabolic profile is found further testing is recommended for confirmation. The confirmatory test would need an additional sample to be taken once again from the child.  Since most routine screening labs do not have DNA testing capabilities, the child is referred to specialised labs leading to further delays in diagnosis & treatment apart from causing further agony for the parents. The DNA based test, is considered a gold standard and is most reliable for confirmation as it does not get impacted by interferences such as medications, nutrition, temperature, or preterm status.  LifeCell’s “RightStart” Newborn screening, which adopts an integrated DNA testing approach, does not require an additional sample since a portion of the sample collected initially can be used. Also no additional costs would need to be incurred by the parents. “RightStart” provides more accurate results and also saves time & effort enabling a speedy diagnosis to initiate treatment. More importantly, the parents are alerted to the risk only if the DNA tests are positive thereby reducing parental anxiety. LifeCell anticipates substantial increase in adoption of the RightStart Newborn Screening and is collaborating with PerkinElmer, a global market leader in newborn screening.  LifeCell will use PerkinElmer’s fully automated and high throughput analyser - the Genetic Screening Processor (GSP) instrument, a first by a commercial lab in India. Also as another first-in-India, LifeCell will incorporate PerkinElmer’s next generation NeoBase 2 non-derivatized MS MS kit, which can screen for all the common amino acid, organic acid and fatty acid oxidation, as well as purine and peroxisomal metabolic disorders – more than any other commercial kit available in the market today.      ]]> https://biospectrumindia.com/news/97/11783/i-genetic-launches-trutest-labs-for-specialty-testing-.html https://biospectrumindia.com/news/97/11783/i-genetic-launches-trutest-labs-for-specialty-testing-.html Wed, 03 Oct 2018 11:20:00 +0530 Infusing technology, expertise and experience of specialty testing into everyday diagnostics, major pathology chain, iGenetic Diagnostics has launched TruTest Laboratories, with the aim to share its world of high-end molecular diagnostics, which drive faster and accurate testing solutions, with the masses. TruTest Laboratories powered by iGenetic Diagnostics is operational pan-India with its centres located in Mumbai, Delhi, Bengaluru, Hyderabad, Indore, Nagpur, and Kochi. With a wide menu of pathology testing options, TruTest Laboratories will offer tests ranging from routine biochemistry to cutting-edge molecular pathology.      “With the launch of TruTest Laboratories, we have made a specialized platform to capture the growing requirements of everyday testing in India, with the objective of serving the masses with even better and dedicated focus. TruTest Laboratories is powered by i-Genetic Diagnostics high-end capabilities and state-of-the-art pathology labs, with pathology centres equipped with next generation sequencing, molecular diagnostics, cytogenetics, and more. The growing threat of various communicable and non-communicable diseases has made it mandatory for people to go for regular health check-ups. Many diseases are asymptomatic initially and show symptoms at later stages, while many infections share common or similar symptoms. Regular testing has become the need of the hour for early diagnoses and treatment. TruTest Laboratories will be playing an important role in plugging the huge gap of testing needs and avenues to obtain fast and accurate testing results.” With the launch of TruTest Laboratories, people can avail inaugural specialized packages that cater to everyday testing needs and at the same time fall lighter on pockets. At present, the new diagnostic lab has launched with TruTest 360 health check-up, Monsoon package, Women Wellness Health Check-up package, Senior citizen health package for men, and Senior citizen health package for women. In addition to the clinically relevant differential diagnosis panels, TruTest Laboratories will provide a range of individual laboratory tests. “There is growing consciousness for health in the country, and we believe in empowering people to choose the specific tests.  TruTest Laboratories is offering a menu of over 1400 tests which takes care of all necessary testing needs. We are also providing home collection services in select cities. We aim to be one of the most powerful tools in the hands of our medical community as well as become a responsible health partner for the society.” With this launch of TruTest Laboratories, iGenetic has further strategically reinforced its brand as the one that provides best in class diagnostic services and as a contender to reckon with in the closely competitive medical testing industry. ]]> https://biospectrumindia.com/news/97/11762/mtai-points-out-ill-information-on-needles-syringes-pricing.html https://biospectrumindia.com/news/97/11762/mtai-points-out-ill-information-on-needles-syringes-pricing.html Thu, 27 Sep 2018 13:45:00 +0530 We have studied the stories in media recently and found them ill-informed and wrong at multiple places especially the mention of our member companies Becton Dickinson, and B Braun Medical. The story states that the two companies have not followed an NPPA (National Pharmaceutical Pricing Authority) advisory to reduce high margins on needles and syringes. We want to put on record that there has been no advisory from NPPA on reducing high margins on needles and syringes so far. Therefore the question of not following the advisory does not arise. There was a voluntary decision by AISNMA last year to cap the margins on syringes and needles. AISNMA (All India Syringes & Needle Manufacturers Association) represented only a small section of the industry and many domestic and overseas manufacturers were not engaged in these deliberations. Therefore, their voluntary decision was not binding on all players in the industry. To reiterate, as the voluntary decision was taken by a limited group of the industry, specific companies can’t be blamed for not following a decision for which they were not consulted. To maintain propriety and correct legal protocol, several companies of the medical device industry had approached AISNMA under appropriate associational umbrellas to discuss the regulation of syringes and needles. However, AISNMA had refused to have a discussion on the same. MTaI and its member companies have been champions of trade margin rationalization for needles and syringes for all manufacturers. It is heartwarming to know that AISNMA is following our footsteps now. On all other medical devices also, MTaI has championed the advocacy on trade margin rationalization with the government. MTaI believe that trade margins should be fixed at Price to Trade for overseas manufacturers to create a level playing field vis-à-vis domestic manufacturers. This is in line with recommendations of Department of Pharmaceuticals’ report on Trade Margin Rationalisation, which is an informed, even-handed and practical report. In summary, we would like to say that AISNMA might have written to the government on the subject now, but MTaI and its members have been in touch with the government for more than a year asking for compulsory trade margin rationalisation.   Pavan Choudary, Director General, Medical Technology Association of India (MTaI) ]]> https://biospectrumindia.com/news/97/11757/abbotts-troponin-test-gets-ce-mark-to-predict-heart-attack-in-advance.html https://biospectrumindia.com/news/97/11757/abbotts-troponin-test-gets-ce-mark-to-predict-heart-attack-in-advance.html Thu, 27 Sep 2018 10:50:00 +0530 Cardiovascular diseases are the leading cause of death globally. Yet unlike other conditions, heart disease can be prevented if identified early and managed through lifestyle changes and medication as needed.  To help people take control of their heart health, Abbott announced that its High Sensitive Troponin-I blood test is the first troponin test with CE Mark that can more accurately predict the chances of having a heart attack or other cardiac event potentially months to years in advance in people who otherwise appear healthy. This life-changing technology has the potential to transform how doctors identify those at risk for developing heart disease because the diagnostic test uses a biomarker specific to the heart. European guidelines currently recommend that doctors look at indirect heart health factors, such as a person's cholesterol levels, blood pressure as well as if they have diabetes or are a smoker, to determine risk for developing heart disease.  A substantial body of research has shown that measuring a person's troponin levels using Abbott's High Sensitive Troponin-I test provides better predictive information for determining a person's chances of developing future heart disease when added to the current standard of care. ]]> https://biospectrumindia.com/news/97/11745/indian-syringes-needle-maker-seek-price-cap-inclusion-in-nlem.html https://biospectrumindia.com/news/97/11745/indian-syringes-needle-maker-seek-price-cap-inclusion-in-nlem.html Tue, 25 Sep 2018 16:05:00 +0530 Pharma Industry usually shies from Regulations however in an unusual move the Syringes & Needle manufacturers have written to Chairman of NLEM (National List of Essential Medicine) Committee  to include all types of syringes & needles in NLEM (National List of Essential Medicines), at the earliest so that they could come under Price capping of MRP. In a letter to Prof. Balram Bhargava, Secretary, Department of Health Research & DG, ICMR Indian Council of Medical Research AISNMA (All India Syringes & Needle Manufacturers Association) raised serious concerns regarding the various news reports of exorbitant price being charged to the hapless Patients and the pleas of Patient groups to address this exploitation. Indian Syringes & Needle Manufacturers have urged the government to impose a price cap to stop the exploitation of patients by hospitals. The price limit on needle and syringe would curb unethical practices in the medical field and overcharge of these products by hospitals.  “We want a level-playing field. Hospitals need not sell at the MRP and are free to sell under the Max Retail Price but Doctors have been blaming us (manufacturers) for labelling products with high MRP. With Price Caps or Cap on Trade Margins ,our endeavour is to make the hospitals focus on making the procurement decision on the quality of the Medical Devices and their buying price for cost minimization rather than current skewed market where hospitals focus on Margins to be made on Higher MRPs and tend to seek profit maximisation . This has taken away the motivation of hospitals to be Cost competitive and patients feel exploited leading to a Trust deficit” said Mr. Rajiv Nath, President, All India Syringes and Needles Manufacturers Association (AiSNMA)  For the purpose of self-regulation and as responsible manufacturing, the Domestic Syringe Manufacturers had earlier set a path breaking self regulatory precedent by deciding to voluntarily cap trade margins to maximum 75% over their discounted net Ex-Factory prices (including GST) and to implement this latest by Republic Day, 26thJanuary, 2018 as a contribution to Citizens of India, for the benefit of Patients. This covers all categories of Syringes & Needles – Disposable / Auto Disable / Reuse Prevention / Needle Stick Prevention / Insulin Pen Needle, etc. But four companies - Lifelong Meditech along with MNC Manufacturers / Importers - Becton Dickinson, B Braun Medical and Nipro Medical were opposed to this self regulatory advisory.  "To stop Patient exploitation being carried out by some Manufacturers / Importers through unethical marketing, it is of utmost importance for the Govt. to include all types of syringes & needles in NLEM (National List of Essential Medicines). Though, Medical Devices are Engineering Products, they are being regulated as Drugs under the Drugs & Cosmetics Act, 1940 and Syringes and Needles are possibly more important than implants, as being used on almost all hospitalized Patients. Syringes and needles are among the most commonly used device which account for huge bills. There is also a higher risk of reuse and misuse of syringes & needles leading to burden of disease when Syringes & Needles carry excessively high MRP and become unaffordable." said Mr Vimal Khemka, Secretary of AiSNMA.  “Since the Product range is very large due to different variety and sizes, instead of an absolute Price Cap which may be impractical, we, at AISNMA, collectively seek capping of Trade Margin to Maximum 75% on Ex-Factory prices for domestic manufacturer and on CIF value (landed cost) for Overseas Manufacturers on all types of syringes and needles, as this is more transparent and traceable in GST regime, being the 1st point of imposition of GST”, added Mr. Nath This will give a level playing field for all the domestic Manufacturers as well as with Overseas Manufacturers, and will cut down, more than 1000% mark up being currently charged at present, by some of the manufacturers / importers and having a huge price disparity of 3 times the MRP for the same Products and specifications. “This landmark initiative if carried forward speedily by NLEM committee will help benefit the common people at large and simultaneously boost domestic manufacturing, reduce motivation to Reuse Syringes, increase the market size and correct market dynamics to a cost based competitive procurement by Hospitals. We urge the Government for carrying forward the process from NLEM listing to being declared a Scheduled Formulation to Price capping via Trade Margin Capping.This will ensure towards making these essential products available across the country at affordable prices.” Added Mr. Nath.   ]]> https://biospectrumindia.com/news/97/11738/made-in-india-supraflex-stent-clinically-at-par-with-global-standards.html https://biospectrumindia.com/news/97/11738/made-in-india-supraflex-stent-clinically-at-par-with-global-standards.html Mon, 24 Sep 2018 14:30:00 +0530 Supraflex, a cardiac drug eluting stent designed and manufactured in India has been confirmed to be at par with Abbott’s Xience through an investigators-driven study called 'TALENT'. Dr Patrick Serruys a globally renowned cardiology researcher was the chair for the TALENT trial. The findings of the TALENT trial were presented at the 'late breaking trial session' at Transcatheter Cardiovascular Therapeutics 2018 (TCT), the largest global conference of cardiologist currently underway in San Diego, USA. This study was conducted in 7 countries - United Kingdom, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria - across 23 renowned centres with a sample size of 1435 patients. Xience is regarded as global standard in safety and efficacy for drug eluting stents. Over 5,00,000 stents are used in India every year. A cardiac stent is a device used to unblock clogged arteries. Drug eluting stents are coated with medicines that help lower recurrence chances of an artery narrowing after corrective surgery. Presenting the findings of TALENT trial, Dr Patrick Serruys, said, “Safety and efficacy of Supraflex SES with ultra thin struts and biodegradable polymer were compared with Xience EES in all comers-population. Supraflex was found to be non-inferior to the Xience for DOCE (device oriented end points) at 12 months in an all comer-population* with a lower rate of CI-TLR** in the per protocol analysis.” Padma Shri Dr Upendra Kaul, one of the leading cardiologist from India was the co-chair of the TALENT Study. Commenting on the study, Dr Kaul said, "There remained a perception that stents produced outside of India were superior to homegrown devices. There were demands from Indian manufacturers to prove that their devices are comparable to those made elsewhere in robust clinical trials. TALENT is the first such trial to yield positive results and stands out with a far better efficacy compared to the competitors.” Prof. R. de Winter, MD, Academisch Medisch Centrum, Amsterdam, The Netherlands; and A. Zaman, MD, Cardiac Catheter Laboratories, Royal Freeman, Newcastle, UK, were the Principal Investigators for the TALENT trial. The TALENT trial included mean patient age of 65 years, and about three-quarters were men, with about 40% of patients presenting with stable angina and 60% with Acute Coronary Syndromes (ACS). The rate of a device-oriented composite endpoint of cardiac death, target-vessel MI, and clinically indicated TLR at 12 months was 4.9% with Supraflex and 5.3% with Xience, a difference that met criteria for non-inferiority (P< 0.001).  In a per protocol analysis Supraflex had better efficacy as compared to Xience. The rate of clinically driven re procedure rate was 1.2% vs 3.1% which was also statistically significant. The lower the re procedure rate the better it is.   Supraflex is available in 65 countries across the world and is the largest selling drug eluting stent of SMT (Sahajanand Medical Technologies), India’s largest stent manufacturer. Supraflex has advanced features like biodegradable polymer and ultrathin strut* (60µm) thickness compared to 81 µm strut thickness and biostable polymer coating of Xience. The TALENT clinical study results matches with the published meta-analysis, highlighting benefits of lower strut thickness.  Mr Ganesh Sabat CEO, SMT said, “The result of the TALENT study is significant for the coronary stent industry. The success of this study resonates well with make in India. We are proud to establish India name in such a complicated and high end life-saving technology industry. We now have strong credentials to achieve our dream of becoming a leading global player in coronary stent industry.” ]]> https://biospectrumindia.com/news/97/11724/neuberg-diagnostics-launches-new-facility-in-chennai.html https://biospectrumindia.com/news/97/11724/neuberg-diagnostics-launches-new-facility-in-chennai.html Fri, 21 Sep 2018 14:45:00 +0530 Neuberg Diagnostics has recently launched advanced laboratory facility including molecular diagnostics and genomics testing at its Chennai division, Neuberg Ehrlich. The facility up gradation marks the 80th anniversary of Ehrlich lab, which was recently renamed Neuberg Ehrlich after it became part of the Neuberg Diagnostics group. The new facility was launched by VK Singh, Minister of State for External Affairs and Overseas India Affairs, and C Vijaya Baskar, Minister of Health and Family Welfare, Tamil Nadu. In a public-private partnership with the Tamil Nadu government, Neuberg Ehrlich has set up a newborn screening lab at the Institute of Child Health and Hospital for Children, Egmore, to screen babies for congenital hypothyroidism and congenital adrenal hyperplasia. The new laboratory inauguration also saw the launch of Neuberg Anand Academy of Laboratory Medicine aimed at fostering research and for providing fellowship programme on super-speciality pathology techniques. ]]> https://biospectrumindia.com/news/97/11701/lumenis-organises-workshop-for-mastering-laser-treatments-in-aesthetics.html https://biospectrumindia.com/news/97/11701/lumenis-organises-workshop-for-mastering-laser-treatments-in-aesthetics.html Tue, 18 Sep 2018 17:30:00 +0530 Lumenis Ltd, world’s largest energy-based medical device company for surgical, aesthetic and ophthalmic applications organized the ‘GuruKool’ exclusive scientific program and workshop at Hotel Conrad, Bengaluru. The one day event was specially designed to provide training to doctors practicing in the field of Aesthetics. Various eminent dermatologists and cosmetologists conducted knowledge enhancement sessions using breakthrough technologies like ResurFX, Lightsheer, AcuPulse and Ultrapulse, used for treating skin resurfacing, laser hair reduction as well as burn scars. Dr. Ganesh Pai, Medical Director, DERMA-CARE, Skin and Cosmetology Centre, Mangalore, said “It was a great knowledge sharing experience, we appreciate the initiative taken by Lumenis by organizing the classes on the Pioneering technology introduced in the field of aesthetics”. Dr. Padmavathi Surapaneni, Sr. Dermatologist, and Cosmetologist, Pragna skin laser clinics, Hyderabad said “We are thankful to Lumenis for conducting this convention on aesthetics, as it will keep us abreast on latest laser technology available in the Indian market. The gold standard Lightsheer technology which is a path-breaking technology is the new generation of Laser Hair Reduction system.” Dr. Sonia Feroz, Aesthetic Dermatologist & Director at Serene Skin & Laser Centre, Trivandrum said, “The aesthetics industry is witnessing a perpetual evolution with state of the art technologies from Lumenis making treatments of a range of aesthetic indications easier and efficient”. On the occasion, Mr Pradeep Singh, Director Aesthetic, Lumenis India, said “With GuruKool, we endeavor to create a knowledge sharing platform aimed to keep doctors abreast of latest advancements in the field of aesthetics. The demonstrations and hands on sessions organized on Lumenis technologies like ResurFX, Lightsheer, UltraPulse and AcuPulse makes this convention more experiential and promotes real-time learning. Such scientific sessions and workshops enable doctors to enhance their laser procedure techniques and perform procedures in a more convenient and controlled way”. “We as the pioneers in medical device market looks to facilitate with such interactive session in future too”. Mr Singh added. The one day user convention also saw panel discussions on the changing trends in modern aesthetics. The other top most doctors who attended the GuruKool session were Dr SC Rajendran, Dr Shireen Furtado, Dr Pallavi Reddy, Dr Vindhya Pai, Dr Rahul Pillai among others etc. As a global leader in the development and commercialization of innovative aesthetic energy based technologies, Lumenis has invented Intense Pulsed Light (IPL) for skin treatments, LightSheer – diode laser for hair removal and the UltraPulse – the most powerful CO2 laser in aesthetic medicine, among many others. Lumenis has redefined medical treatments and set numerous technological and clinical gold standards. ]]> https://biospectrumindia.com/news/97/11672/uk-india-collaborate-to-curb-amr.html https://biospectrumindia.com/news/97/11672/uk-india-collaborate-to-curb-amr.html Fri, 14 Sep 2018 14:35:00 +0530 A £3 million interdisciplinary research project will address the growing threat of drug-resistant infections in India. The project will develop innovative diagnostics to curb antimicrobial resistance (AMR), one of the biggest threats to global public health. The DOSA programme - Diagnostics for One Health and User Driven Solutions for AMR - brings together nine leading academic institutions, five from India and four from the UK. The three-year DOSA programme will begin with a meeting of the project group on 24-25 September at the Indian Institute of Technology Delhi (IIT-D). The project is jointly funded by UK Research and Innovation/Economic and Social Research Council, the Newton Fund, and Government of India's Department of Biotechnology. Indian partners include the Indian Institute of Technology Delhi; the Centre for Cellular and Molecular Platforms Bengaluru; ICAR-Central Institute of Fisheries Technology, Cochin, Kerala; ICAR-National Dairy Research Institute, Karnal, Haryana; Silchar Medical College and Assam University, Silchar, Assam. UK partners include the Universities of Edinburgh, Bradford and Southampton and University of the Arts London. ]]> https://biospectrumindia.com/news/97/11663/changes-in-chinese-regulations-stimulate-market-for-cro.html https://biospectrumindia.com/news/97/11663/changes-in-chinese-regulations-stimulate-market-for-cro.html Wed, 12 Sep 2018 12:15:00 +0530 A recent circular issued by the Chinese State Drug Administration (SDA), has opened up a large market for Contract Research Organizations (CROs) across the world. The circular (referred to as No. 52 of 2018) allows Chinese pharmaceutical companies to use clinical trial data from studies conducted outside China for their drug submissions to the SDA. Global CROs have long been keen to enter the growing Chinese market for pharmaceutical drug testing. Sharing his views on the development, Dr. Satish Sawant, the Founder and CEO of Accutest Research Laboratories, Mumbai said, "In the current market context, it is critical for pharma companies in China to accelerate their speed-to-market. This is a challenging problem given the high cost of clinical studies in China and the shortage of high-quality CROs. Accutest has successfully partnered with leading pharma companies in China to achieve these goals. With this announcement, we will finally be able to collaborate with Chinese pharma players for their pivotal study submissions to the SDA." This announcement is especially beneficial for CROs like Accutest which have an early mover advantage in the Chinese market. Dr. Sawant outlined Accutest's work experience in China, "Over the past 5-6 years, Accutest has conducted more than 250 Bioequivalence (BE) clinical trials for Chinese clients, including 150+ pre-BE studies for the SDA." "Accutest has also supported Chinese clients by conducting BE studies for global submissions for regulators like the US Food & Drug Administration, the World Health Organization and the European Medicines Agency. With more than 30 active clients in China, we are definitely a preferred choice as a strong and reliable CRO for SDA submission studies."He stated further. ]]> https://biospectrumindia.com/news/97/11659/molecular-assessment-to-improve-detection-of-chronic-endometritis.html https://biospectrumindia.com/news/97/11659/molecular-assessment-to-improve-detection-of-chronic-endometritis.html Tue, 11 Sep 2018 14:35:00 +0530 Chronic Endometritis (CE) is a persistent inflammation of the endometrial lining, caused by infection of the uterine cavity, mainly by bacterial pathogens. Because it is usually asymptomatic, and current classical diagnosis methods (histology, hysteroscopy and microbial culture) are unsatisfactory, CE is often overlooked, although it affects approximately 30% of infertile women, and its prevalence in patients with RIF and Recurrent Pregnancy Loss (RPL) could reach up to 60%. A recent study carried out by Igenomix, a company that provides  advanced services in reproductive genetics has demonstrated that molecular assessment of CE is feasible, is a faster cheaper method for the diagnosis of CE as compared with the classical methods and should be considered as a way of improving detection of this often-undiagnosed endometrial pathology. “ALICE (Analysis of Infectious Chronic Endometritis), detects the most frequent bacteria that cause CE. This expands the service offered by Igenomix, to evaluate the endometrium factor at the microbiological level, with the aim of improving the clinical management of patients with this silent disease.” Says Dr. Rajni Khajuria, Ph.D, Laboratory Manager Of IGENOMIX India. ALICE can be beneficial for any patient wishing to conceive, by assessing the microbiological environment that the embryo will encounter at implantation. ALICE may also be beneficial for patients with a history of RPL and/or RIF, because CE has been linked to these events. “ALICE uses the latest Next Generation Sequencing technology to provide microbiome information in endometrial tissue by analyzing the levels of specific bacteria that cause CE. The technology is based on DNA extraction followed by amplification and barcoded sequencing of the bacterial 16S ribosomal RNA gene.” further adds Dr. Rajni. This bacterial gene, conserved in all bacteria, presents nine variable regions with species-specific DNA sequence. This enables the taxonomic assignment and relative quantification of CE bacteria present in a sample. Furthermore, the ALICE report will focus on the detection and abundance of those specific bacteria that cause CE. These bacteria are: Enterococcus spp., Enterobacteriaceae spp., Streptococcus spp., Staphylococcus spp., Mycoplasma spp, and Ureaplasma spp. In addition, other pathogens associated with sexually transmitted infections (STI), such as Chlamydia trachomatis and Neisseria gonorrhoeae will also be reported. “The ALICE report will recommend antibiotic therapy for the pathogens that are detected.” Says Dr. Rajni. ]]> https://biospectrumindia.com/news/97/11651/microsoft-srl-to-use-ai-for-cancer-detection.html https://biospectrumindia.com/news/97/11651/microsoft-srl-to-use-ai-for-cancer-detection.html Tue, 11 Sep 2018 10:25:00 +0530 Tech giant Microsoft has collaborated with SRL Diagnostics to train its artificial intelligence (AI) system in detecting cancer. Microsoft plans to teach its AI system to find the traits of cancerous cells that trained pathologists do manually by looking at a slice of the patient’s tissue on a glass slide. SRL’s bank of more than one million such slides from past diagnosis will be used as the training material for the AI system. Microsoft has already deployed its AI system for early detection of blindness in people suffering from diabetes and assessing cardiovascular health of patients. According to Microsoft, this cancer-detecting solution will not replace the need of an oncologist, but the goal is for the AI system to speed up, make more accurate and give valid pointers to the doctor to make the right diagnosis. This will reduce the cost of treatment, better utilise the time of trained specialists to reach more patients and make healthcare in general more patient-centric. ]]> https://biospectrumindia.com/news/97/11639/promega-biotech-and-core-diagnostics-enter-into-technology-collaboration.html https://biospectrumindia.com/news/97/11639/promega-biotech-and-core-diagnostics-enter-into-technology-collaboration.html Fri, 07 Sep 2018 14:45:00 +0530 Promega Biotech India Private Ltd., a 100% subsidiary of Promega Corporation USA, a leader in providing innovative solutions and technical support to the life sciences industry, has entered into a technology collaboration with CORE Diagnostics. The collaboration allows CORE Diagnostics to leverage Automated Nucleic Acid Purification with Promega Integrated Quantitation systems. The Maxwell® Automated Nucleic Acid Purification Instrument offers benchtop automation with worry-free, walk-away purification of DNA and RNA from a variety of different sample types. The collaboration agreement focuses on the implementation of the Promega Microsatellite Instability (MSI) technology for Immuno-Oncology. The patent-protected MSI technology is considered the gold standard molecular assay for detecting DNA mismatch-repair deficiency. “We are very pleased that CORE diagnostics and Promega have entered into a collaboration," said Dr. Rajnish Bharti, General Manager at Promega India. “Following our recent discussions with a number of labs, it is clear that they view the Promega MSI assay as an important tool for determining DNA mismatch repair deficiency that is a more straightforward measurement relative to next-generation sequencing. We strongly believe that Promega technologies will be adding substantial value to CORE Diagnostics.” Zoya Brar, Founder and Managing Director, CORE Diagnostics, added, “In modern medical science, the role of state-of –the-art diagnostic tools such as nucleic acid purification is of utmost importance and plays a critical role in selecting the most effective clinical intervention. We are constantly innovating in all aspects of service delivery in underserved high-end diagnostics market. We are excited to partner with a global leader in the field of biochemistry, genomics and molecular biology which will help us adapt and be able to scale our capabilities to automating the current sample processing and expand our network to make the high-end techniques available to Indian healthcare market in the best possible way.” Gurgaon-based CORE Diagnostics brings latest cutting edge testing techniques in areas of definitive diagnosis and Molecular Diagnostics, Flow Cytometry, Immunohistochemistry, Histopathology, Cytogenetics and Cytopathology for the patients in India. These tests bring targeted, customized treatment one step closer to reality and can help the health practitioners provide the most actionable information to address the various treatment needs of patients in India to get better outcomes.   ]]> https://biospectrumindia.com/news/97/11581/medgenome-brings-relief-to-a-family-through-genetic-testing-.html https://biospectrumindia.com/news/97/11581/medgenome-brings-relief-to-a-family-through-genetic-testing-.html Thu, 30 Aug 2018 19:20:00 +0530 Genetic testing helped a couple to know about their unborn child’s health, who were anxious regarding the health of their unborn child with respect to hearing loss, which gave them hope and allayed their anxiety. A couple hailing from Vijayawada, Andhra Pradesh was a happy family until they discovered that their first born suffered from hearing and speech loss. The couple experienced a lot of emotional trauma and were worried for their next child. They opted for genetic counselling to understand if their second child will have the same issues as their first child. They consulted Dr Sunitha Tella, Head of the Clinical Genetics and Fetal Medicine Department, at the Institute of Genetics and Hospital for Genetic Diseases, Hyderabad who suggested the family to undergo genetic testing at MedGenome Labs, Bangalore. In India, over a million babies are born each year with genetic disorders and 20-30 % of infant mortality is due to these disorders. “In this case, the first born child had cognitive disorders hence it was natural for us to recommend genetic testing to understand if the hearing impairment was due to genetic factors basis which we could take appropriate screening measures when they plan their second child”, said Dr Sunitha Tella. The blood samples of the parents and their first child was sent to MedGenome Labs, Bangalore for the genetic analysis. The report revealed their first born had two mutations (variants) in the GJB2 gene, which is associated with hearing loss, while the parents were found to be carrying one mutation each, making them “carriers” of the disease. Meaning, their child may have 25% chance of being affected with hearing impairment. Carriers are those individuals who carry one defective copy of a gene (due to a mutation) but aren’t affected with the disease. However, these carriers are at a high risk of having a child who is affected, especially when they are married to another carrier for the same gene. This was the case in their first child, who inherited two defective copies of the GJB2 Gene, one from each parent. “During Saroja’s next pregnancy, the fetus was tested for these two variants. Fortunately, it was found that the fetus was only harboring one of the two mutations found in the first child. This meant that the child would be a carrier of the disease and wouldn’t suffer from hearing loss,” said Dr Sunitha Tella. Couples should undergo pre- conception counselling (i.e before planning for the next pregnancy) with a Genetic Counsellor; especially when there is positive family history for a disorder. Such counselling sessions help the couple better understand the risk to the child as well as help recommend a suitable prenatal genetic test. “Genetic testing is becoming an integral part of clinical practice in India as it can aid in prevention, treatment/management and prediction of a disease thereby bringing down the burden of healthcare. Clinicians across the world today understand the importance of genetic testing and include it as part of the routine tests when necessary,” said Dr V L Ramprasad, COO, MedGenome Labs, Bangalore. Some common genetic disorders in India are beta-thalassemia, muscular dystrophy, cystic fibrosis, sickle cell anaemia, congenital adrenal hyperplasia, spinal muscular atrophy, growth hormone deficiency, haemophilia, mucopolysacchridosis, G6PD deficiency, and non-syndromic hearing loss etc. Awareness and early detection is the only way to prevent these disorders from being passed down to next generations.   ]]> https://biospectrumindia.com/news/97/11546/ibsc-inks-pact-with-aami.html https://biospectrumindia.com/news/97/11546/ibsc-inks-pact-with-aami.html Mon, 27 Aug 2018 10:30:00 +0530 The Indian Biomedical Skill Consortium (IBSC) has recently signed a Memorandum of Understanding (MoU) with the Association for the Advancement of Medical Instrumentation (AAMI) paving the way for biomedical professionals to gain recognition. AAMI has certified over 7,000 biomedical engineering professionals in over 100 countries. The MoU was signed by Dr. Jitendar Sharma, MD & CEO, AP MedTech Zone (AMTZ), and Dr. Brad Schoener, vice-president (Innovation), AAMI, in the presence of Dr. Renu Swaroop, Secretary, Department of Biotechnology, Sunita Sanghi, Director General, National Skill Development Agency, Shyam Sunder Bang, Chairman, NABCB (Quality Council of India) and others. IBSC is an initiative of AMTZ coming up near Visakhapatnam in collaboration with the NABCB - Quality Council of India and Association of Indian Medical Devices Industry (AiMeD). ]]> https://biospectrumindia.com/news/97/11529/bd-medical-pharma-systems-to-bring-technovation-season-8-.html https://biospectrumindia.com/news/97/11529/bd-medical-pharma-systems-to-bring-technovation-season-8-.html Wed, 22 Aug 2018 14:00:00 +0530 BD Medical-Pharmaceutical Systems is set to organise its annual flagship event Technovation Season 8 on global trends and innovative technologies for the pharmaceutical industry. With Smart Partnerships…Great Solutions as this year’s theme, the event will be conducted across three cities – Mumbai (August 28), Ahmedabad (August 29) and Hyderabad (August 30). Over the years, BD has partnered with pharmaceutical companies to customize and develop differentiated delivery systems that help maximize the potential of their drugs with healthcare providers and patients. Technovation Season 8 will bring global experts to deliberate upon topics including Getting Future Ready through Innovation, Administration Challenges, and Clinic to Home Care: Self Administration Devices, besides Supply Chain Efficiencies and Regulatory Dynamics. Commenting on the upcoming event, Pavan Mocherla, Managing Director-BD India & South Asia said, “Drug delivery systems are critical to the success of pharmaceutical companies helping them differentiate their offering in clinical and therapeutic areas. Drug manufacturers look at developing injectable drug delivery systems to enhance patient comfort, dose compliance and ultimately improve health outcomes. Technovation in its 8th season, will bring key pharma stakeholders together to interact with peers and SMEs in the field of drug delivery systems and further strengthen customers’ knowledge in this domain. We believe such customer engagement initiatives will help BD prudently respond to evolving customer needs and provide them great value.” With more than 50 years of experience in the prefillables market, BD Medical-Pharmaceutical Systems has had the necessary resources to support drugs throughout its life cycle, from development to launch and beyond. Raymond Chow, Vice President, BD Medical-Pharmaceutical Systems, Greater Asia adds, “Being a global leader in prefillable parenteral drug-delivery systems comes with a responsibility. With our deep knowledge, Innovative technology, product development expertise, we are able to leverage the extensive worldwide resources of BD to meet our ever evolving customers’ needs. I am glad that Technovation Season 8 will offer shared learning opportunities for professionals from across the industry to address today’s challenges and be future ready.” BD Medical-Pharmaceutical Systems has been conducting Technovation since 2010 to increase awareness of new delivery technologies and solutions through discussions and sharing best practices from within the pharmaceutical industry. ]]> https://biospectrumindia.com/news/97/11521/mtai-to-organise-mtai-medtekon-2018-on-20th-september.html https://biospectrumindia.com/news/97/11521/mtai-to-organise-mtai-medtekon-2018-on-20th-september.html Tue, 21 Aug 2018 14:40:00 +0530 Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant investments in India, is organising ‘MTaI MedTekon 2018’ to bring together healthcare experts for devising a mechanism to ensure Pradhan Mantri Jan Arogya Abhiyan addresses all stakeholders adequately. Pradhan Mantri Jan Arogya Abhiyan (PRAJAA), which was called Ayushman Bharat - National Health Protection Scheme (AB-NHPS) earlier, will provide health insurance worth Rs. 5 lakh per family. It will cover 50 crore people, or nearly 40% of India’s population. The scheme is scheduled for a formal launch on September 25. MTaI MedTekon 2018 will be organised on 20th September 2018 with representation from the government, NITI Aayog, hospitals, pharmaceuticals industry, medical device manufacturers, doctors, et. al. to deliberate on the role medical technology sector can play in conjunction with other stakeholders for successful implementation of the scheme. MTaI will share the key findings and recommendations of the summit with the government for consideration. “India has one of the lowest health insurance penetration in the world. As a result, a significant portion of the population is out of the purview of formal healthcare services. In this scenario, PRAJAA is a ground-breaking scheme that will make healthcare affordable without adding any financial burden to the user,” MTaI Chairman and Director General Mr. Pavan Choudary said. Mr. Badhri Iyengar, Chairman of MTaI MedTekon 2018 said, “From the industry’s perspective, the size of healthcare industry is expected to reach $372 billion by 2022-23 from $160 billion in 2017. How we can club this growth with healthcare services through smooth implementation of NHPS is a subject that requires further discussion.” “We seek to address this subject in detail at MTaI MedTekon 2018 with participation from the government, NITI Aayog, and all segments of healthcare value chain. Foreign healthcare delegates will share key learnings of public health schemes in other countries,” added Mr. Diwaker Rana, Co-chairman of MTaI MedTekon 2018. ]]> https://biospectrumindia.com/news/97/11505/trivitrons-kiran-launches-complete-portfolio-of-advanced-radiology-solutions.html https://biospectrumindia.com/news/97/11505/trivitrons-kiran-launches-complete-portfolio-of-advanced-radiology-solutions.html Fri, 17 Aug 2018 12:20:00 +0530 Kiran Medical Systems, the Radiology Division of Trivitron Healthcare launches complete portfolio of Advanced Digital X-Ray systems, DSA C-Arm, Modular Smart OT Solutions and Satin Touch Radiation Protection Products at Traumacon 2018, Mumbai. The Radiation Protection portfolio of Kiran now features the antimicrobial Satin Touch fabric with the choice of 3 core materials - Leadlite, Ultralite and Zerolead. Kiran Medical Systems is a leading radiology focused medical equipment manufacturer with a comprehensive range of innovation driven radiology equipment including Digital Radiography Systems, C-Arms, X-ray Equipment, Imaging Accessories and Radiation Protection Products. Kiran's manufacturing facility is registered with USFDA. The products conform to norms of CE as per the European Council's Medical Device Directive (MDD) 93/42/EC and Personal Protective Equipment (PPE) Regulation EU 2016/425. Kiran Radiation Protection Products conforms to European Standards EN 61331-1 2014, EN 61331-3 2014, ASTM 2547. Kiran products are exported to 165 countries across the globe. Kiran’s range of radiology equipment is made cost-effective to the Indian market by adhering to the company’s inherent ‘Make in India’ philosophy. With 50-65% of the entire raw materials designed and manufactured from scratch in India, there is a significant cost reduction in the development of the equipment subsequently enabling the brand to make the products available at affordable prices. This also helps in leveraging local technological competence and entrepreneurial mindset to the global market thereby promoting Indian products and solutions designed to increase efficiency at reduced costs at an international level. ]]> https://biospectrumindia.com/news/97/11495/advamed-responds-to-knee-implant-price-capping-extension.html https://biospectrumindia.com/news/97/11495/advamed-responds-to-knee-implant-price-capping-extension.html Thu, 16 Aug 2018 11:40:00 +0530 "AdvaMed and its members would like to express their concern on the National Pharmaceutical Pricing Authority’s notification released today that extends the applicability of the ceiling prices fixed for orthopaedic knee implants for another year. We hoped for a better outcome that values Quality, Safety and Clinical results and expected an informed decision taken after considering the consultations and deliberations held over the course of time. As per the NPPA notification dated 22 July 2014, DPCO 2013 Para 19, should be applicable for only one year. Post that, DPCO para 21 states, increase of annual MRP within 10% should be allowed. In the last one year, since the knee price cap, rupee has depreciated over 10%, while local inflation has pushed up operating costs upwards of 6%. The industry had put this up to request to the authority requesting for a 10% minimum increase in prices, which for non-scheduled formulations (knee implants fall under this category) is provisioned for, under DPCO. This request was a valid request and should have been considered, given the increasing cost pressures on a falling rupee, which for the next 1 year could take a toll on all companies. Further, some other essential knee implant component’s costs like bone cement, cost of depreciation value of instruments and other value-added services provided by the knee implant companies, which were erroneously omitted last year, should have been included in the revision order. Instruments are not regulated medical devices and do not come under the purview of the NPPA as they are not covered under DPCO 2013. Instruments cannot be covered in the knee implant price cap, as this act is not applicable to non-notified instruments. Having said that, we would continue to constructively engage with NPPA and the government in general to support industry in its fair ask. It is key to seek measures to collaborate with different stakeholders and find mutually acceptable solutions such as ‘Trade Margin Rationalization.’ Rationalizing trade margins on the basis the first point of the sale i.e. the distributor rather than on the landed cost of devices would address the issue of excessive markups while bringing greater discipline and transparency to the channels. At the same time, margin controls would permit manufacturers of medical devices to continue to innovate and compete on the basis of clinical merit and value of the technology. We would like to reiterate that it is critical to evaluate the long-term negative impact of such decisions on patient outcomes, the consequent increase in adverse events, and the subsequent rise in the future healthcare costs. Also, there is a dire need to encourage research-based global medical device companies to invest in the Indian market for patients to benefit from the latest technologies. For the industry, it will enable us to create a healthy ecosystem where these high-quality technology companies will have a positive impact on the revolutionary NHPS scheme." ]]> https://biospectrumindia.com/news/97/11492/s3v-vascular-technologies-launches-nextgen-hydrophilic-coated-ptca-balloon-catheter.html https://biospectrumindia.com/news/97/11492/s3v-vascular-technologies-launches-nextgen-hydrophilic-coated-ptca-balloon-catheter.html Thu, 16 Aug 2018 11:00:00 +0530 Bangalore-based S3V Vascular Technologies Private Limited, a medical devices manufacturing company launched Nextgen PTCA (Percutaneous Transluminal Coronary Angioplasty) Balloon Catheters into the domestic market.  PTCA in layman’s language is a minimally invasive procedure to open up blocked coronary arteries, allowing blood to circulate unobstructed to the heart muscle.  Talking about the S3V, medical devices market, Dr. Bindu Dey, Secretary, Technology Development Board, Ministry of Science & Technology, Government of India said, "We were good on pharma, diagnostics, but on devices front, we lag way behind. 75 percent of medical devices used in treatment of cardiovascular treatment are imported." She further said, "By the year 2025, the medical device market would grow to USD 50 billion and that Indian companies must take advantage of it."  The newly introduced device “Nextgen PTCA Balloon Catheters”, according to Mr. Badari Narayan, Managing Director is the futuristic product with a future full of promises.  "Currently, these medical devices are imported at high cost. We will be shortly launching these products phase wise after obtaining necessary regulatory approvals," informed Badari Narayan.  The advantages of this are manifold such as improved trackability, pushability, low profile and higher burst pressure. It will assist to succeed even in complex anatomies due to enhanced lubricity.  The new PTCA Balloon Catheter manufacturing facility set up at Hootgalli Industrial Area, Mysore-Karnataka was just inaugurated by Padmashri Dr. C.N.Manjunath, Director, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Bangalore.  Dr. Bindu Dey, Secretary, Technology Development Board, Ministry of Science & Technology, Government of India inaugurated The Hydrophilic Coating Division. This Division is capable of coating products of lengths up to 200cm. Dr. Bindu Dey and Sri T. Suneel Kumar, IPS, Commissioner of Police, Bangalore launched the Nextgen PTCA Balloon Catheters.  The state-of-the-art integrated manufacturing facility will develop futuristic medical devices and is being set up with an Investment of Rs 70 Crore.  S3V Vascular Technologies is founded by a group of enticing and thought-provoking alumni of the Indian School of Business, Hyderabad who were classmates of the founding batch of PGPMAX (Post Graduate Program in Management for Senior Executives), program of ISB which was started in the year 2010.  Disclosing more on the present medical device industry in India, Mr. Badari Narayan opined, "India has a huge potential for advanced medical device products in the country. At present, about 90 percent medical devices are being imported from other countries. The Indian medical devices market is huge. It is expected to be US $ 8.6 billion in next two years. And industry experts say it has even greater potential to grow to US $ 59 billion by the year 2025. The market is expected to grow 15 to 20 per cent annually, which is much higher than the global industry of 5 to 7 percent."  India with 1.3 billion population, will reach a situation by the year 2025, one million cardiovascular procedures will be done every year. The Cardiovascular disease burden, which is already high, is going to be even higher. If local entrepreneurs are encouraged by the state and central governments, India can become a leading player in the world with its existing talent pool and low manufacturing costs.  There are two major challenges to MAKE IN INDIA for class III medical devices. The first challenge is to manufacture high-quality Medical Devices at affordable prices to attract outsource of manufacturing to India. The solution for this is to set up integrated manufacturing plants. The second challenge is the regulatory brand perspective wherein MAKE IN INDIA products need to compete with globally manufactured USFDA approved products. The solution for this is that even MAKE IN INDIA products should have the highest regulatory approvals like USFDA approval or CE certification  Technology Development Board (TDB), Ministry of Science & Technology, Government of India entered into an agreement with S3V Vascular Technologies Pvt. Ltd. Under this agreement, TDB has provided financial assistance to S3V Vascular Technologies to set up an Integrated PTCA Balloon Catheter manufacturing plant and for USFDA (510 K) approval of Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter. This was done under Make in India program and to make project for Medical Devices a success.  Subsequently, S3V has entered into a non-exclusive global License and Supply Agreement with DSM Biomedical, a global solutions provider in biomedical science and regenerative medicine, for integration of their hydrophilic coating. The material master file of this coating is available with all regulatory bodies including the USFDA. Many medical devices using these coatings have received FDA approval and CE marking. The Technology Transfer from DSM Biomedical is currently being implemented.  Royal DSM is a purpose-led global science-based company in Nutrition, Health and Sustainable Living. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company is listed on Euronext Amsterdam.  S3V will be using this technology for coating Angioplasty Catheters i.e. PTCA Balloon Catheters, PTCA Guide Catheters, Intracranial Micro-catheters, Introducer Sheaths, CVC Catheters and Guide Wires, informed Badari Narayan.  Adding further, Badari Narayan said, “We are in the stage of commercialization of Current Generation Drug Eluting Stent (DES).  We have initiated CE certification for the Innovative Nextgen Nickel Cobalt Free Drug Eluting Stent which will be the first of its kind in the world.”  CE Certification is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.  "We will soon initiate animal trials for resorbable Metallic Vascular Scaffold," informed Badari Narayan.   The other products on the anvil to launch include Arterial Sheath, Coated CVC Catheters and Urology Catheters, added Badari Narayan. ]]> https://biospectrumindia.com/news/97/11487/mit-media-labs-brings-a-mind-reading-device.html https://biospectrumindia.com/news/97/11487/mit-media-labs-brings-a-mind-reading-device.html Tue, 14 Aug 2018 15:25:00 +0530 MIT Media Labs has recently launched the first ever compact headset that reads signals sent from the brain to the mouth and the jaw MIT Media Lab has devised a headset which can read one's thoughts, and process answers for questions and replies to its wearer without the need for speaking out loud. As per a report by CNET, when we think about something, our brain sends a signal to our mouth and jaw, and AlterEgo captures these signals. MIT Media Labs states that the communication between AlterEgo and the person wearing it, happens through bone-conduction headphones. The technology transmits sound vibrations through the face bones without travelling through the ear canal. Thus, AlterEgo could easily communicate with the individual while he is actually talking to someone else. In its trials that involved 15 people, AlterEgo had an accurate transcription rate of 92 percent. Arnav Kapur, the graduate student who led AlterEgo's development, describes it as an "intelligence-augmentation device." ]]> https://biospectrumindia.com/news/97/11477/brains-introduces-novel-cutting-edge-machine-for-spine-surgery-.html https://biospectrumindia.com/news/97/11477/brains-introduces-novel-cutting-edge-machine-for-spine-surgery-.html Mon, 13 Aug 2018 17:20:00 +0530 Moving ahead with the growing pace of technology, Bengaluru based Brains Hospital has recently acquired the cutting-edge mobile fluroscopy machine - Ziehm Hybrid RFD 3D HE Intra-operative Imaging System. Brains is the first hospital in India to house this world’s best high-end equipment used for spine surgery that gives 100 percent accuracy& 3D Imaging. What’s so special about this machine? Surgery of the spine and nerves have to be under taken with utmost meticulousness and accuracy. Even a slight variation can lead to serious consequences as well as disability. So, this highly mobile apparatus, offers surgeons three dimensional imaging with exceptional clarity, helping them achieve pin-point precision with never-before confidence and speed. At Brains, surgeons pair the Ziehm with another first-in-India technology, the Stryker navigation system NAV3i , a computer-assisted, navigation guidance suite that gives real-timefeedback about the position, direction and progress of surgeryaided by in-built pre-programmed and planned safety checks. Thus BRAINS has established the first of its kind Hybrid operation theatre for the spine surgery. Deployed together, these two systems have helped doctors achieve perfection in spinal surgery and reduce the chances of errors to near zero. Dr. Venkataramana NK, Founder & Chief Neurosurgeon, Brains Hospital said: “These technologies enable our surgeons to operate with extremely small incisions with minimal invasiveness and muscle dissection without disturbing the joints, ligaments and other supportive elements.They also greatly enhance the possibility of using minimally invasive surgery for fixing unstable spines percutaneously, using key holes.” “Pushing our capabilities in spinal surgery even further we have inducted sophisticated neuro-spinal endoscopy systems and technologies like the Foramenoscopy, that helps us perform state-of-the-art spinal surgeries with world-class precision and excellent outcomes,” he further added. ]]> https://biospectrumindia.com/news/97/11454/wish-foundation-to-add-health-centres-by-october.html https://biospectrumindia.com/news/97/11454/wish-foundation-to-add-health-centres-by-october.html Thu, 09 Aug 2018 17:10:00 +0530 Wadhwani Initiative for Sustainable Healthcare (WISH Foundation), set up by IGate Co-founder Sunil Wadhwani, is planning to add 100 technology-enabled health and wellness centres in the country by October, its founder donor said. The foundation is looking to open these centres in partnership with various state governments and agencies such as United States Agency for International Development (USAID). "We will be opening 100 technology enabled health and wellness centres by October in Uttar Pradesh, Madhya Pradesh and Rajasthan," said WISH Foundation Founder Donor Sunil Wadhwani. This will be in addition to 10 such centres at present, he added. These centres provide diagnostics, tele-consultation and dispensing of medicines to the patients, Wadhwani said. In addition, WISH is already running 300 primary health clinics providing free healthcare to the people, he added. WISH seeks to implement healthcare models through partnerships with state governments, international agencies and the private sector, Wadhwani said. On his personal contribution to the WISH Foundation, Wadhwani said, "Over last four and half years, my family foundation has spent around Rs 50 crore in the programmes of WISH Foundation, and going forward it will be much higher." The focus of WISH Foundation is primary healthcare as it is the foundation of all healthcare, he added. ]]> https://biospectrumindia.com/news/97/11417/aster-cmi-performs-one-of-a-kind-liver-transplant-in-india.html https://biospectrumindia.com/news/97/11417/aster-cmi-performs-one-of-a-kind-liver-transplant-in-india.html Thu, 02 Aug 2018 17:55:00 +0530 53-year-old Mr. Ashwath ST became the first person in Asia to receive a liver transplant using specialised technology to preserve and revitalise the donated organ. Mr Ashwath had been suffering from end stage liver disease and had been waiting for a transplant for several months. His wife saidOur entire family had been evaluated but there were no suitable matching donors. Our only hope was getting an organ from a deceased donor. However, he was very sick and had multiple admissions for infection and bleeding. The family had almost lost hope when they got a call that there may be a suitable donor. However, an assessment of the liver revealed that it may contain 50% fat. Luckily for Mr Ashwath, a new way of preserving livers was available in India in the form of the OrganOx Metra (normothermic machine perfusion). In doing so, he became the first recipient of a preserved liver using this new technology in Asia. The transplant was carried out at Aster CMI Hospital, Bengaluru. The procedure took almost 18 hours. First the organ was retrieved from the donor. This was then prepared and placed on the machine. The machine monitored several parameters related to the liver on a real time basis which allowed the transplant surgeons to assess the liver function before transplant. The procedure was witnessed by several of the country’s leading transplant surgeons. Mr Ashwath’s operation started after the organ had been assessed and function confirmed. The transplanted liver worked almost immediately after the procedure. Mr Ashwath had a smooth recovery and was discharged home in less than two weeks. The OrganOx metra device brought to India by Duraent Lifesciences, a Hyderabad based healthcare technology company, speaking on the occasion, Mr. Subhit Kumar, CEO Duraent Lifesciences, said, “We are proud to have delivered this technology to India in association with our European partners at OrganOx Metra. The device has many features apt for the challenges facing the Indian liver transplant ecosystem like time-critical access to donor livers and maintaining organ quality. It is our aim to ensure that every patient and hospital in India will have access to our technology soon. I congratulate the Integrated Liver Care team at Aster CMI on the first successful implementation in India.” There are insufficient numbers of deceased donations available to meet waiting list demands. In India, many patients die before they could benefit from a life-saving transplant. Some organs cannot be utilised because donations occur in small cities and the organs cannot be reliably and safely transported to transplant centers in time. Equally some donated livers may come from older donors or may have fat (fatty liver) which may not function well after the retrieval. The solution may come from the way in which organs are preserved before transplantation. For the past 50 years, the accepted way to preserve organs after donation is to put them in a specialised fluid in an ice box. This is very different from the way organs function in the body. A new machine, OrganOx Metra has created a system that allows blood to circulate through the liver. When the organ is in a device that mimics the body, doctors can see it taking in blood and letting out bile, and can better tell how it might work in a patient. Using this technology, it is possible to transport organs from different regions while maintaining function. OrganOx Metra technology has only been available in Europe and the US so far, and this is the first time it has been used in Asia. Dr Sonal Asthana, Senior Hepatobiliary and Transplant Surgeon said, “This technology will change the way we preserve organs and allow us to revive the organs before transplantation to ensure better function. Also organs which are donated in far off parts of the country can now be transported to transplant centers and utilised safely.” Dr Rajiv Lochan said, “Current preservation methods do not allow functional assessment of organs before transplantation. In Mr Ashwath’s case it was also important to reduce the storage time to a minimum. The new technology allows for both these functions to occur and better use of donated liver grafts for transplantation. In addition, these livers can be treated to make them better while on the machine.” Liver transplants are complicated procedures and India faces nearly 20-30% of donor rejection rates due to poor quality of preservation and lack of timely access. The current liver donor numbers required annually in India is as high as 9-10 thousand, with donor numbers significantly lower. Duraent seeks to address this disparity and elevate India to a position of global leadership for liver transplants. ]]> https://biospectrumindia.com/news/97/11413/google-glass-helps-autistic-children-to-socialize-with-others.html https://biospectrumindia.com/news/97/11413/google-glass-helps-autistic-children-to-socialize-with-others.html Thu, 02 Aug 2018 17:05:00 +0530 A new smartphone app that pairs with a Google Glass headset uses facial recognition software to give the wearer real-time updates on which emotions people are expressing. In a pilot trial, 14 children with autism spectrum disorder used this program at home for an average of just over 10 weeks. After treatment, the kids showed improved social skills, including increased eye contact and ability to decode facial expressions.   Dennis Wall, a biomedical data scientist specializing in pediatrics at Stanford University, and colleagues built the new Google Glass program to offer children with autism at-home, on-demand behavioral therapy.   The headset’s camera records the faces of people in the child’s field of view and feeds that information to a smartphone app. The app, trained on hundreds of thousands of face photos, is designed to recognize eight core expressions: happiness, sadness, anger, disgust, surprise, fear, contempt and calm.   When the app recognizes an expression of one of these feelings, it sends the information to the Google Glass wearer either by naming the emotion through the headset speaker or by displaying an emoticon on a small screen in the corner of the right spectacle frame.   In the pilot trial, children ages 3 to 17 with autism used this Google Glass program around their families for at least three 20-minute sessions per week. Before and after treatment, parents completed questionnaires that rated their children’s social skills.   On this Social Responsiveness Scale, scores below 60 fall within the “normal” range, whereas scores 60 to 65, 65 to 75, and above 75 indicate mild, moderate and severe autism, respectively. Over the course of treatment, the children’s average score dropped from 80.07 to 72.93.   Wall and his team are currently working on one such experiment with 74 children ages 6 to 12.  If the Google Glass therapy performs well in future clinical trials and is cleared for widespread use, it could be a powerful learning aid for many children with autism which affects an estimated 1 in 59 children in the United States, according to the U.S. Centers for Disease Control and Prevention.   ]]> https://biospectrumindia.com/news/97/11408/iit-k-to-develop-unique-medical-implants.html https://biospectrumindia.com/news/97/11408/iit-k-to-develop-unique-medical-implants.html Thu, 02 Aug 2018 10:25:00 +0530 The Indian Institute of Technology (IIT), Kharagpur has set up a Bioelectronics Innovation Laboratory to develop battery-free implantable medical devices for treatment of brain, nerve, muscle or spinal cord disorders that are untreatable by using standard medical practices. The team aims to implant coin sized electronic chips with wireless energy supply for rehabilitation and prostheses applications. Unlike the standard pace-makers that require a surgery every 5 to 10 years due to limited battery-life, this solution will depend on wireless power transfer and intelligent communication schemes. The novel bioelectronic devices will be able to sense bio-signals, process information to make intelligent decisions, and control diseased organs by electrical methods. Grants have been received from IIT Kharagpur, under MHRD Imprint program and SFTIG Indo-Canadian Fellowship grant. It is in the process of setting up collaborations with several hospitals and institutes in India and abroad. ]]> https://biospectrumindia.com/news/97/11395/digital-mammography-equipment-introduced-in-karnataka.html https://biospectrumindia.com/news/97/11395/digital-mammography-equipment-introduced-in-karnataka.html Tue, 31 Jul 2018 13:25:00 +0530 Breast cancer is one of the most common cancers affecting Indian women and early diagnosis of the disease is imperative for better survival rate. Bearing this important thought in mind Trivitron Healthcare in association with Bangalore Baptist Hospital have introduced the 3D Tomosynthesis and Stereotactic guided Vacuum assisted Biopsy system which will be the most advanced digital mammography equipment in Karnataka. 3D Tomosynthesis is an advanced technology which takes less than 4 seconds to scan any abnormality in the breast. Studies have shown that the chances for successful treatment are nearly 100 per cent if breast cancer is detected early. 3D Tomosynthesis removes overlapping, increases lesion visibility, helps to localize structures, reduces repeat studies, helps to detect cancer and improves the quality of patient care with painless mammogram procedures. The accuracy of breast cancer detection through the usage of 3D Tomosynthesis has been incrementally high at 40 percent better detection when compared to 2D mammogram. Complimenting on the inauguration, Mr. R Sampath Raj, the Honourable Mayor of Bangalore said, ‘My hearty congratulations to Bangalore Baptist Hospital for bringing first of its kind advanced 3D Digital Mammography technology to Bangalore. Across the world, breast cancer is the No.1 cause of cancer death in women. Early detection of breast cancer is the key to save lives. My humble request to all women above 40 years is to get their annual mammogram screening done as this will help them to detect breast cancer at an early stage.’ Addressing his thoughts about the innovation, Dr. Naveen Thomas Director, Baptist Hospital said, ‘Bangalore Baptist Hospital is committed to fight breast cancer with world-class technologies and we now have the first of its kind advanced digital mammography equipment in Karnataka with 3D Tomosynthesis technology and stereotactic guided vacuum assisted biopsy. The advanced 3D Tomosynthesis technology removes the overlapping structures and increases the lesion visibility allowing the clinicians to pick up cancer at a very early stage.  The stereotactic guided vacuum assisted biopsy system helps in localizing and removing the lesion completely resulting in therapeutic treatment as well. The entire procedure is painless and improves the overall patient care. We now have a world-class comprehensive breast care centre in Bangalore that will benefit the people of Karnataka.’ Commenting on this initiative, Mr. M Brahadeesh, President – Imaging, Trivitron Healthcare said, ‘Trivitron is committed to reduce the breast cancer deaths in India by improving mammography penetration in both urban and rural locations. Selenia Dimensions with 3D Tomosynthesis which is installed at Baptist Hospital, Bangalore is the most advanced 3D Digital Mammography equipment available in Karnataka as of now. The time taken for a Tomosynthesis scan will be less than 4 Seconds. We are proud to be associated with Baptist Hospital and are certain that this advanced mammography technology will save many lives in the coming years. ]]> https://biospectrumindia.com/news/97/11378/trivitron-healthcare-baptist-hospital-unveil-unique-digital-mammography-equipment-in-karnataka.html https://biospectrumindia.com/news/97/11378/trivitron-healthcare-baptist-hospital-unveil-unique-digital-mammography-equipment-in-karnataka.html Fri, 27 Jul 2018 16:30:00 +0530 Breast cancer is one of the most common cancers affecting Indian women and early diagnosis of the disease is imperative for better survival rate. Bearing this important thought in mind Trivitron Healthcare in association with Bangalore Baptist Hospital have introduced the 3D Tomosynthesis and Stereotactic guided Vacuum assisted Biopsy system which will be the most advanced digital mammography equipment in Karnataka. 3D Tomosynthesis is an advanced technology which takes less than 4 seconds to scan any abnormality in the breast. Studies have shown that the chances for successful treatment are nearly 100 per cent if breast cancer is detected early. 3D Tomosynthesis removes overlapping, increases lesion visibility, helps to localize structures, reduces repeat studies, helps to detect cancer and improves the quality of patient care with painless mammogram procedures. The accuracy of breast cancer detection through the usage of 3D Tomosynthesis has been incrementally high at 40 percent better detection when compared to 2D mammogram. Complimenting on the inauguration, Mr. R Sampath Raj, the Honourable Mayor of Bangalore said, ‘My hearty congratulations to Bangalore Baptist Hospital for bringing first of its kind advanced 3D Digital Mammography technology to Bangalore. Across the world, breast cancer is the No.1 cause of cancer death in women. Early detection of breast cancer is the key to save lives. My humble request to all women above 40 years is to get their annual mammogram screening done as this will help them to detect breast cancer at an early stage.’ Addressing his thoughts about the innovation, Dr. Naveen Thomas Director, Baptist Hospital said, ‘Bangalore Baptist Hospital is committed to fight breast cancer with world-class technologies and we now have the first of its kind advanced digital mammography equipment in Karnataka with 3D Tomosynthesis technology and stereotactic guided vacuum assisted biopsy. The advanced 3D Tomosynthesis technology removes the overlapping structures and increases the lesion visibility allowing the clinicians to pick up cancer at a very early stage.  The stereotactic guided vacuum assisted biopsy system helps in localizing and removing the lesion completely resulting in therapeutic treatment as well. The entire procedure is painless and improves the overall patient care. We now have a world-class comprehensive breast care centre in Bangalore that will benefit the people of Karnataka.’ Commenting on this initiative, Mr. M Brahadeesh, President - Imaging, Trivitron Healthcare said, ‘Trivitron is committed to reduce the breast cancer deaths in India by improving mammography penetration in both urban and rural locations. Selenia Dimensions with 3D Tomosynthesis which is installed at Baptist Hospital, Bangalore is the most advanced 3D Digital Mammography equipment available in Karnataka as of now. The time taken for a Tomosynthesis scan will be less than 4 Seconds. We are proud to be associated with Baptist Hospital and are certain that this advanced mammography technology will save many lives in the coming years.’ ]]> https://biospectrumindia.com/news/97/11353/iit-d-engineers-design-low-cost-prosthetic-knee-joint.html https://biospectrumindia.com/news/97/11353/iit-d-engineers-design-low-cost-prosthetic-knee-joint.html Tue, 24 Jul 2018 15:05:00 +0530 Researchers at the Indian Institute of Technology, Delhi (IIT-D) have designed and fabricated a low-cost, and light-weight polymeric polycentric prosthetic knee joint with energy-efficient gait option. The researchers took seven years to come up with this knee joint design. It has been tested clinically at Department of Physical Medicine and Rehabilitation, Government Medical College, Thiruvananthapuram. According to the researchers, the result showed that the patient using the new prosthetic walked closer to natural gait pattern compared to the conventional ones. The energy expenditure was also reduced. The prosthetic is made up mainly of polymeric material through injection molding technique and is polycentric in design consisting of an upper part, a lower part with pylon adaptor, a middle bar, a side bar and connecting bolts. It weighs a mere 350 grams. ]]> https://biospectrumindia.com/news/97/11338/bill-gates-introduces-dementia-diagnostics-accelerator.html https://biospectrumindia.com/news/97/11338/bill-gates-introduces-dementia-diagnostics-accelerator.html Fri, 20 Jul 2018 16:25:00 +0530 Bill Gates has announced the introduction of the Diagnostics Accelerator, a project of the Alzheimer’s Drug Discovery Foundation (ADDF), to further ideas for earlier and better diagnosis of Alzheimer’s disease. Gate is leading the funding with a $30million investment. The project is set up as a venture capital fund, bringing together biotech companies, academics, charities and other partners. One of the main bottlenecks in Alzheimer’s drug development has been a lack of validated biomarkers to diagnose patients noninvasively, monitor progression or reveal subgroups that may benefit from specific therapies in clinical trials. Currently, the only way to definitively diagnose the disease is through an autopsy; tests of cognitive decline need to rule out other possible causes. Positron emission tomography scans can be used to detect amyloid plaque deposits in the brain, but the technology is not widely available and carries high radiation exposure. ]]> https://biospectrumindia.com/news/97/11328/researchers-design-the-worlds-first-3d-color-x-rays.html https://biospectrumindia.com/news/97/11328/researchers-design-the-worlds-first-3d-color-x-rays.html Thu, 19 Jul 2018 15:15:00 +0530 Scientists in New Zealand have designed an x-ray scanner capable of capturing human bodies in full color and three dimensions, which could give doctors a clearer picture for diagnosing cancer and other diseases, minimizing the need for invasive surgeries. The new scanner has its origins in a tool that contributed to research into the universe’s fundamental particles and functions much like a camera. It counts subatomic particles as they meet pixels when its electronic shutter is open. That allows it to generate high-resolution images of soft tissues, including minute disease markers. “We can make out details of various tissues, like bones, fats, water and cartilage, all functioning together inside the human system,” said Anthony Butler, a radiologist at Otago University in New Zealand, who developed the scanner with his father, Phil Butler, a physicist. Whereas traditional scanners send x-rays through the body and show only two colors, white where bone tissue has absorbed the beams, and black where soft tissues have not, the new machine is sensitive enough to detect specific types of tissue (such as bone, cartilage, fat, and water) by analyzing individual light particles. The new scanner matches individual X-ray photon wavelengths to specific materials, such as calcium. It then assigns a corresponding color to the scanned objects. The tool then translates the data into a three-dimensional image. The tissue data are then used to construct a full color reconstruction of the body. The scanning technology was adapted from a tool that physicists used at CERN, the European particle physics laboratory near Geneva, Switzerland, to detect particles moving through the Large Hadron Collider. ]]> https://biospectrumindia.com/news/97/11309/jiva-unveils-diagnostic-protocols-for-ayurveda.html https://biospectrumindia.com/news/97/11309/jiva-unveils-diagnostic-protocols-for-ayurveda.html Tue, 17 Jul 2018 10:35:00 +0530 Jiva Ayurveda has launched first-of-its-kind diagnostic protocols for Ayurveda, with the aim to create a definite structure for this ancient healing tradition and turn it into globally accepted medical science. The launch ceremony was organized recently in New Delhi in the presence of Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH, Govt. of India. The newly developed protocols called Ayunique are the result of a huge data analytics project that was initiated by Jiva Ayurveda six years ago. Using Big Data analytics and machine-learning techniques, the 5,000-year-old knowledge of Ayurveda and personalized treatment records of lakhs of patients at Jiva have been consolidated to offer the most advanced decision-support system for Ayurveda doctors. This will assist them in making root-cause based diagnosis in a structured, standardized and data-driven manner while allowing for the personalization of treatment. Said Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH, Govt. of India: “On behalf of the Government, I congratulate Jiva Ayurveda for coming out with diagnostic protocols for Ayurveda, which is truly a unique achievement. Most practitioners of traditional systems of medicine are not able to communicate effectively with modern science. This science belongs to all humanity and we should not hesitate to deploy it for the advancement and validation of Indian healing systems. Jiva is a prime example of entrepreneurship which is using science to further the cause and acceptability of Ayurveda. AYUSH systems of medicine need a digital platform and IT-based solutions, and the diagnostic protocols by Jiva are a welcome step in this direction.” Said Dr. Partap Chauhan, Director, Jiva Ayurveda: “Ayurveda is fundamentally a personalized system of medicine that aptly addresses the world’s challenge of moving away from a symptomatic-only approach to medicine. The Jiva Ayunique protocols are like the operating system for Ayurveda practice that structure the practice of Ayurveda and creates a wealth of data. They will truly enable a scientific approach in providing a more precise, personalized Ayurveda and establishing it as a globally accepted treatment science.” Added Rishi Pal Chauhan, President, Jiva Group: “Ayurveda practitioners around the world are referred to as health and wellness coaches because Ayurveda is not recognized as medical science. Jiva Ayunique is a concrete step towards changing this status quo. The dream of ‘health for all’ can only be achieved if Ayurveda is made widely available throughout the world. However, for that to happen, acceptance of the science behind Ayurveda is a must.” Jiva Ayunique Protocols have already been validated on more than 25,000 patients. Jiva is also collaborating with number of universities and institutes worldwide to undertake further research studies based on these. The Jiva Health App was also launched. It provides authentic and actionable Ayurvedic health and wellness information through a personalized feed. The content is curated by the world-renowned Ayurvedacharya Dr. Partap Chauhan. At the core of the app is a recommendation-engine powered by artificial intelligence, which, based on user’s consumption patterns and preferences, serves them with a personalized stream of content. Users can take number of Ayurvedic tests and health assessments. The app allows patients to connect with Jiva doctors for personalized consultation and treatment. They can also track their treatment history and access their records. The App is available on Google Play Store and Apple Store. ]]> https://biospectrumindia.com/news/97/11308/mtai-guides-medtech-experts-on-mdr-that-could-impact-packaging.html https://biospectrumindia.com/news/97/11308/mtai-guides-medtech-experts-on-mdr-that-could-impact-packaging.html Tue, 17 Jul 2018 10:20:00 +0530 Medical Technology Association of India (MTaI), an association of research-based medical technology companies who have made significant investments in India in R&D and manufacturing, today organized ‘MTaI Medical Packaging Seminar’ to educate medical device professionals in the country on new Medical Device Rules introduced in Europe, which could impact exports to that continent. According to the regulatory experts at the seminar, medical device regulations are changing steadfastly around the world and many of these new guidelines will impact packaging. They stated that these new changes are enabled to develop packaging that will help end-users in ensuring the safe use of sterile medical devices.  Thierry Wagner, Director- Regulatory Affairs, E. I. DuPont de Nemours (Luxembourg) detailed the features and the current implementation issues of EU’s new Medical Device Regulations (MDR) adopted in April 2017. He also mentioned new directives and regulations evolving in the Association of Southeast Asian Nations (ASEAN), India, and the Eurasian Economic Union (EAEU).  “In light of the current technological advancements, healthcare trends and the need for better patient protection, new state-of-the-art laws have emerged. These new regulations with their advanced features will take a device life-cycle approach, from design to clinical evaluations, certification, distribution including the required post-market clinical follow-up systems,” he said.  Chairman & Director General of MTaI, Pavan Choudary said, “Medical Device packaging is vital for product safety, performance, pertinent information disclosure and even sustainability. A small defect can mean a life-threatening event. Packaging is a highly technical and scientific field, which demands professionals to stay abreast of ever-changing regulations, innovations in material and in testing requirements.  With this seminar we make our first large scale knowledge sharing contribution to Make in India”. While addressing the audience, Dr V. G. Somani, Joint Drug Controller of India, said, "India has gone on to implement Medical Device Rules in line with international standards, so as to promote Ease of doing business in India and step towards the goal of Make in India”.  Kevin Grum, Global Technical Services Leader, EI Dupont Nemours (USA) said, “Often packaging is an afterthought in the life of a medical device. We are here to change the mindset and deliver the message of how packaging design can add value to the product and even save patient lives.”  The seminar was inaugurated by Diwaker Rana, Chairman, Skill Building Committee, MTaI, who said, “Aligning ourselves with PM’s overall vision of Ayushman Bharat, MTaI persists in its dedication towards skill-building of healthcare professionals and the manufacturing personnel in the country by providing such state of the art training”.  MTaI Medical Packaging Seminar, organized in association with its member company DuPont, is the first of several programmes that MTaI has planned under the aegis of Skill Building Committee. The seminar was focused on Sterile Medical Packaging Regulatory and Standards Review requirements after the new EU MDR, as well as Packaging Engineering and Design, Peel Strength & Microbial Barrier, etc. ]]> https://biospectrumindia.com/news/97/11297/navitas-titled-as-a-leader-in-idc-marketscape.html https://biospectrumindia.com/news/97/11297/navitas-titled-as-a-leader-in-idc-marketscape.html Fri, 13 Jul 2018 11:40:00 +0530 TAKE Solutions announced that its dedicated life sciences company, Navitas has been recognized as a ‘Leader’ in the IDC MarketScape: Worldwide Life Science R&D BPO Services 2018 Vendor Assessment. Leadership in this study is based on the breadth of life science R&D business process outsourcing services offered, geographical footprint and global delivery capabilities, industry-specific expertise, and diligent vetting of customer references to examine vendor capabilities. Navitas Life Sciences was one of nine life science R&D IT BPO vendors selected to participate in this study based on the IDC MarketScape’s stringent research and due diligence process. IDC MarketScape’s vendor assessment: “Navitas Life Sciences has extensive experience working with pharmaceutical and biotechnology companies of all sizes and across multiple geographies. Navitas Life Sciences is strongly differentiated from its more traditional market competitors by its broad portfolio of clients, ranging from small and midsize organizations to large global pharmaceutical companies. Deep, task-level client experience over a wide variety of specific BPO services also separates Navitas Life Sciences from its peers in this IDC MarketScape. Relative to other vendors discussed in this study and based on feedback from multiple customer references, Navitas Life Sciences received high marks for its technical skills and capabilities, deep bench and proactive approach to project work, and ability to contribute as a strategic partner when needed.”   Ram Yeleswarapu, President, Navitas Life Sciences said, “We are honored that our domain centricity in Life Sciences was recognized in the form of a listing as ‘Leader’ in the prestigious IDC MarketScape 2018 Assessment”. Speaking on the latest technological innovations, he also added,” Artificial Intelligence (AI) will significantly transform or impact the life sciences space. This along with robotics and cognitive technologies is important for better outcomes, safety, and compliance and lower costs. The use of AI will provide anticipated savings of nearly US$ 150 billion by the mid-2020s for the United States’ healthcare economy.” Alan Louie, Research Director of IDC Health Insights' Life Science R&D Strategy and Technology research, noted, "While still somewhat smaller than its traditional IT outsourcing counterpart, BPO in the life sciences remains an important contributor to industry success. The scope of life science R&D BPO continues to expand as more and more processes are operationalized and preferred IT partners are tasked with implementing and maintaining new processes and procedures. As a result, leading IT service providers are increasingly working as partners with their industry sponsors to deliver operational excellence while contributing to ongoing industry transformation that will ultimately automate well-defined, highly repetitive tasks. While IDC continues to expect that IT outsourcing overall will continue to grow by double digits over the next 5–10 years, we also believe that BPO spending has stabilized and should remain relatively constant over the near term." ]]> https://biospectrumindia.com/news/97/11293/cepheid-to-establish-manufacturing-footprint-for-xpert-mtb-rif-tests-in-india.html https://biospectrumindia.com/news/97/11293/cepheid-to-establish-manufacturing-footprint-for-xpert-mtb-rif-tests-in-india.html Fri, 13 Jul 2018 10:25:00 +0530 US-based leading molecular diagnostics company, Cepheid Inc. (a wholly owned subsidiary of Danaher) unveiled its newest configuration in the GeneXpert® family of systems, the GeneXpert® Edge, in the country today. The company also announced its ‘Make in India’ initiative by announcing plans to establish their manufacturing footprint in the country for Xpert® MTB/RIF test cartridges which run on the GeneXpert® System. More than 1,200 Cepheid’s GeneXpert Systems have been installed in the last 2 years at various Revised National Tuberculosis Control Program (RNTCP) sites in the country and more than 2.5 million cartridges were supplied last year at various centres of Central TB Division (CTD). The GeneXpert® Edge is expected to be available in India later this year. The GeneXpert® Edge is a portable, easy-to-use system, developed specifically for near-patient testing, to help support a one visit test-and-treat approach. With almost 17,000 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics system. Its modular configuration makes it the most scalable platform available, delivering the ability to process from one to eighty tests simultaneously — enabling accurate, fast, and cost-effective test results in both lower volume point-of-care settings and higher volume reference laboratories. Unveiling the GeneXpert Edge, Mr. Peter Farrell, Executive Vice President, Worldwide Commercial Operations, Cepheid said, “The published data point out that Tuberculosis leads to over 400,000 deaths in India every year due to delayed diagnosis and inadequate treatment and there are above 2.5 million new cases of TB every year. Cepheid recognises the need for technological advancement and is committed to contributing significantly to India’s goal of TB eradication. Our ‘Make in India’ plans are a testimony to our commitment towards supporting the Indian Government’s vision of TB eradication by 2025. With this announcement, we aim to establish a manufacturing footprint for Xpert® MTB/RIF test cartridges, thus bringing our global expertise in TB diagnostics to India. Today, we also unveil our latest system innovation, the GeneXpert Edge, which further demonstrates our resolve to participate in India’s fight against TB. We are hopeful that this portable, easy-to-use testing system will help eliminate delays in TB diagnostics by providing definitive results within hours and facilitating fast and easy last-mile delivery even in the remote villages of India.” Mr. Jai Shankar Krishnan, President and CEO, India and Southeast Asia, Danaher said, “Cepheid brings cutting-edge technology and innovation to the molecular diagnostics platform. The launch of the GeneXpert® Edge underscores our commitment to localization and to the eradication of TB in our country. Today Danaher has a strong manufacturing footprint in India. Cepheid’s “Make in India” initiative reflects our continued desire to invest and address local market needs. I am delighted to reinforce Danaher’s and Cepheid’s commitment to India.” Cepheid’s Xpert MTB/RIF test can simultaneously detect tuberculosis (MTB) and rifampicin-resistance mutations, which are markers for MDR-TB strains in under two hours. Xpert MTB/RIF tests have excellent negative predictive value, which allows clinicians to manage TB-negative patients more effectively to prevent unnecessary and costly respiratory isolations. With unprecedented sensitivity for detecting MTB, even in smear negative, culture positive specimens Xpert MTB/RIF provides on-demand results enabling physicians to treat their patients rapidly and effectively. Another version of Cepheid’s test cartridges - Xpert® MTB/RIF Ultra - raises the standard for TB diagnosis by producing test results in less than 80 minutes. It ensures fast active-case finding in HIV-positive patients. It leads to a lower number of culture confirmations due to the high negative predictive value. Xpert® MTB/RIF Ultra has enhanced sensitivity over smear microscopy of MTB-complex in pulmonary samples. The test is CE-IVD approved and is currently in the process of being registered with the regulatory authorities in India Cepheid’s GeneXpert system can run 27 CE-IVD approved tests, including tests addressing the global epidemics, HIV and HCV, on the same platform.    Cepheid has been an active participant in the global fight against TB and is bolstering that commitment by being a part of the ‘Make in India’ initiative. Cepheid is committed to enhancing its presence in India by localising many of its functions, and bringing products customised to the needs of the Indian market. It works closely with the key departments of the government like the Central TB Division, and important stakeholders like the World Health Organization, The Union, FIND, CHAI, stakeholders from private sector and corporations to bring best-in-class products and solutions to India. ]]> https://biospectrumindia.com/news/97/11286/new-wearable-patch-to-detect-heart-ailments.html https://biospectrumindia.com/news/97/11286/new-wearable-patch-to-detect-heart-ailments.html Wed, 11 Jul 2018 15:40:00 +0530 Researchers have found a wearable patch that acts like a sensor can effectively improve the diagnosis rate for heart rhythm disorder without interfering with routine activities. The US Food and Drug Administration (FDA) approved wearable patch acts like a sensor and perform active electrocardiography (ECG) screening to detect irregular heart rhythm condition as well as recent heart attacks. The device resulted in more people receiving critical preventive therapies, which might have gone undiagnosed, said the researchers while emphasising the use of digital medicine technologies to identify undiagnosed Afib disorder in at-risk populations. Atrial fibrillation (Afib) disorder is characterised by increased or irregular heart rhythm that increases the risk of stroke, heart failure and other cardiovascular diseases. "Our study shows an almost threefold improvement in the rate of diagnosis of AFib in those actively monitored compared to usual care," said Steven Steinhubl, Director of digital medicine at Scripps Translational Science Institute (STSI) in California, US. The study was done on 5,214 individuals for one year, with one third of the group being assigned to the monitored cohort and the rest being observational controls. The participants self-applied the wearable sensor patch for two weeks and returned it for analysis. The team found that six per cent of the group developed Afib and nearly three per cent among the controls developed the disease. "This study demonstrates the utility of a digital approach not only to diagnosing asymptomatic AFib, but to the clinical research field as a whole," Steinhubl explained. ]]> https://biospectrumindia.com/news/97/11243/electronic-skin-patches-to-reach-over-10bn-per-year-by-2023.html https://biospectrumindia.com/news/97/11243/electronic-skin-patches-to-reach-over-10bn-per-year-by-2023.html Wed, 04 Jul 2018 15:00:00 +0530 IDTechEx Research's latest market research report Electronic Skin Patches 2018-2028 covers the entire product ecosystem for smart skin patches. With coverage across 26 application areas, >85 companies, 95 different product case studies, historic market data and market forecasts to 2028, it is the most comprehensive study compiled for this emerging product area. It reveals significant opportunity, with a forecast for total annual revenues in electronic skin patches to reach over $10bn per year by 2023 and approaching $15bn per year by 2028. But the case for skin patches must be understood relative to the capabilities of other wearable devices. After all, why bother with a potentially messy, uncomfortable adhesive when a strap or clip onto clothing could be more practical? Firstly, skin patches offer much greater choice in terms of device positioning; as long as there is an area for the patch to be attached, they can be placed there. This is particularly relevant when the sensor requires position close to a certain part of the body (e.g. on the upper chest for sensing the heart, around the head for monitoring concussions, etc.). Secondly, a patch allows for a more consistent means for contact between the device and the body. This may be required for the use of an invasive component such as a microneedle, or in offering a more consistent electrical interface for stable sensor readings. These advantages are particularly relevant in the two largest application sectors for electronic skin patches today: cardiovascular monitoring and diabetes management. The report looks at both of these sections in detail, characterizing the features of the electronic skin patch products being used, the major players, competitive product options and market outlook. In cardiovascular monitoring, mobile cardiac telemetry (MCT) devices sit alongside Holter monitors and cardiac event monitors, each of which can be deployed as a skin patch. They allow for different levels of ambulatory monitoring, enabling at-risk patients to avoid the risks associated with remaining as an inpatient but providing a higher quality of data that can be achieved by other devices such as a smartwatch. In diabetes management, challenges in the markets around traditional self-monitoring of blood glucose via test strips are driving innovation. Leading players have developed continuous glucose monitoring devices (CGM) which can give a longer term picture of blood glucose levels, and are even achieving approval to work directly with insulin pumps, moving towards "closed-loop" systems. Both CGM devices and insulin pumps can be deployed using different types of skin patch, and are covered in detail in the report.   Electronic Skin Patches 2018-2028 covers both sections in detail, including details on product types, technology and a comparison of strategies from players in the space. The report includes a mixture of primary and secondary research, combining executive interviews, extensive conference visits and site visits with companies alongside supporting information from literature and other sources.   IDTechEx's experienced analyst team brings decades of experience and coverage of key parallel or supporting industry and technology sectors to assemble the most comprehensive report on the commercialization of electronic skin patches. ]]> https://biospectrumindia.com/news/97/11221/neuberg-diagnostics-partners-with-premaitha-health.html https://biospectrumindia.com/news/97/11221/neuberg-diagnostics-partners-with-premaitha-health.html Mon, 02 Jul 2018 11:35:00 +0530 Neuberg Diagnostics has partnered with UK’s Premaitha Health for transfer of DNA analysis technology for non-invasive prenatal testing to detect genetic conditions in unborn babies. According to Neuberg, the IONA test (developed by Premaitha) is accurate in detecting risks that an unborn child carries for genetic disorders like Down’s syndrome, Edward’s syndrome and Patau’s syndrome. The test developed by the UK-based molecular diagnostics company uses next generation sequencing technology to estimate the risk of a foetus having genetic disorders. The test is conducted by analysing foetal DNA collected from a sample of maternal blood and has a higher detection rate than current available tests. Testing of the high-tech technology will be carried out at Neuberg’s laboratory in Ahmedabad. ]]> https://biospectrumindia.com/news/97/11211/kiht-birac-ink-pact-for-promoting-medical-technologies.html https://biospectrumindia.com/news/97/11211/kiht-birac-ink-pact-for-promoting-medical-technologies.html Fri, 29 Jun 2018 12:10:00 +0530 BioCubaFarma, Biotechnology Industry Research Assistance Council (BIRAC) and Kalam Institute of Health Technology (KIHT) have signed a Letter of Intent (LoI) to focus on exchange of technologies, products,  innovations, transfer of technologies and commercialization of innovative healthcare products of interest to both the countries. BioCubaFarma is the Cuban organization of biotechnology and pharmaceutical industries which manages the country’s efforts towards manufacturing medicines, diagnostics and medical equipment. With this collaboration, KIHT has made its mark again in international collaboration related to healthcare technologies by being part of the Indian delegation which visited Cuba during June 21 to 23, 2018.  Delegation also comprised of industry experts who demonstrated India’s strength in medical technology from developing efficacious vaccines, to indigenously manufactured kidney dialysis machine with remote monitoring.  ]]> https://biospectrumindia.com/news/97/11183/a-new-mobile-app-offers-all-clinical-services-.html https://biospectrumindia.com/news/97/11183/a-new-mobile-app-offers-all-clinical-services-.html Tue, 26 Jun 2018 12:50:00 +0530 The new ClinicAll App helps to make patients and hospitals independent of stationary bedside terminals. Now, clinic services can be accessed directly from any mobile device.   One of the main advantages of the ClinicAll App is integration. Several software providers have already developed clinic-specific functions but it's not feasible for users to install yet another separate app on their device for each new function.   This is where the ClinicAll App comes into play because it integrates all these functions by use of appropriate interfaces into one single app.   If you are a patient in a hospital, open the ClinicAll App on your device and login and you're ready to use TV, Internet, or retrieve all hospital information: Treatment data, your next lunch meal. You can also control room lighting and your bed.   Doctors and staff inform you via push messages about upcoming activities, dates or rounds. Nurse call is also accessible. Any communication is as easy and simple as possible.   The ClinicAll App runs on iOS and Android devices. A central server provides full access control for all users. There is no need anymore for stationary computer terminals at every patient's bedside radically decreasing cost and effort for installation. ]]> https://biospectrumindia.com/news/97/11181/transasia-organizes-a-knowledge-sharing-platform.html https://biospectrumindia.com/news/97/11181/transasia-organizes-a-knowledge-sharing-platform.html Mon, 25 Jun 2018 17:15:00 +0530 Transasia Bio-Medicals Ltd., India’s leading In-vitro Diagnostic Company recently organized a scientific seminar in East Delhi on the latest advancements in biochemistry and hematology for laboratories. Titled Transasia Scientific Seminar (TSS) Ace, this pioneering academic initiative aims at encouraging the exchange of technical know-how among doctors. The seminar focused on biochemistry and hematology - two of the most critical areas for in-vitro diagnostics. The session on ‘Effective Use of Database Systems by doctors’ by Dr. (Col.) Arun Harith (Sr. Consultant & Head of Department-Biochemistry, Medanta Medicity, New Delhi) highlighted the growing need of database for  improving test outcomes. On the other hand, Dr. (Col.) Jyoti Kotwal (Chairperson & Prof.- Dept. of Hematology, Sir Gangaram Hospital, New Delhi) spoke on ‘Clinical Utility of Advanced Hematology Parameters.’ She emphasized on how the latest automation in hematology helps in enumeration of the different parameters such as IPF, Ret He, Immature Granulocytes, NRBC, etc. and how these parameters help in early diagnosis of diseases.  The sessions were chaired by Dr. Meera Sikka (Head of Dept.- Pathology University College of Medical Sciences.) Transasia offers the entire range of semi and fully automated analyzers and reagents in Biochemistry and Hematology. The latest in clinical chemistry is a fully automated, random access clinical chemistry analyzer,  XL 1000 with a throughput of 1040 tests/ hr. It offers a host of key features such as sample clot detection, permanent hard glass cuvettes and four channel direct ISE measurement, among others, making it an ideal choice for high volume labs. The seminar received an overwhelming response with full-house participation. The over 70 attendees comprised pathologists, physicians and clinicians from reputed Government institutions such as Delhi Cancer institute, IHBAS, Swami Dayanand Hospital, Rajiv Gandhi Super Specialty Hospital, Hegdewar Hospital, LBS Hospital and private institutes such as MAX Healthcare, Kailash Healthcare Ltd., Yashoda Super Specialty Hospital, Dr. Lal PathLabs, Metropolis, SRL Diagnostics, etc. Speaking on the occasion a spokesperson for Transasia Bio-Medicals Ltd. said, “There is an alarming burden on the society from both communicable and non communicable diseases in India. 70% of the treatment decisions are based on lab results. Yet, less than 30% of the Indian population has ever got their blood test done. The major chunk of the 70% population is in the smaller towns. At Transasia, we are committed to reaching out to the pathologists and clinicians in every nook and corner of the country, so that they are well equipped to cater to this population.TSS Ace is a unique platform that empowers the pathologists with the technological advances and encourages exchange of scientific updates, backed by expertise and experience." Over the years, TSS Ace has grown in popularity and has become Transasia’s identity. It has been well accepted as a successful forum and benefits more than 800 pathologists and clinicians annually.  ]]> https://biospectrumindia.com/news/97/11171/medtronic-receives-fda-approval-for-its-new-diabetes-system.html https://biospectrumindia.com/news/97/11171/medtronic-receives-fda-approval-for-its-new-diabetes-system.html Mon, 25 Jun 2018 10:20:00 +0530 Medtronic plc, the global leader in medical technology, recently announced that the U.S. Food and Drug Administration (FDA) has approved the use of the MiniMe 670G system in patients with type 1 diabetes seven years of age and older. This newest system by Medtronic features the company's most advanced SmartGuard technology and most accurate CGM - the Guardian Sensor 3 - which work together to automate the delivery of a personalized amount of basal insulin every five minutes based on sensor glucose values. The system constantly self-adjusts to help avoid highs and lows, allowing patients to spend more Time in Range (the percentage of time spent in the optimal glycemic range of 70-180 mg/dL). FDA approval was based on positive results from a pediatric clinical trial, which demonstrated the safety of the MiniMed 670G system in this younger patient population. In the pediatric clinical trial, there was an increase in Time in Range (70-180mg/dL) for sensor glucose values and a reduction in time spent in both hypoglycemia and hyperglycemia, which is compelling in light of the well-known challenges associated with maintaining stable glucose levels throughout the day and night in this younger age group. ]]> https://biospectrumindia.com/news/97/11167/transasia-appi-bring-in-the-latest-clinical-diagnostic-trends.html https://biospectrumindia.com/news/97/11167/transasia-appi-bring-in-the-latest-clinical-diagnostic-trends.html Fri, 22 Jun 2018 16:10:00 +0530 Transasia Bio-Medicals Ltd., India’s leading in-vitro diagnostic company, recently participated in the 5th annual conference by the Association of Practicing Pathologists of India (APPI) held between 16-17 June, 2018 at The Lalit, Mumbai. Transasia offered participants an opportunity to interact with the industry experts while introducing its latest technologies. The four exclusively organized workshops by Transasia, on Biochemistry, Hematology, Coagulation and Immunology, focused on the latest advancements complete with discussions on first-hand experiences of the participants. Dr. Rumma Manchanda, Prof. & Dir. of Pathology, KEM Hospital, Pune led the session on ‘Approach to bleeding patients and QC in coagulation in standalone labs.’ Dr. Saravanan, Prof. & Head of Dept. – Biochemistry, Stanley Medical College, Chennai, conducted a refresher module on the ‘Basic Principles of Clinical Chemistry.’ Dr. K. Gayathri, Consultant Pathologist, Lifeline Tapadia Diagnostic Centre, Hyderabad, spoke on ‘CBC on 3 Part/ 5 Part analyzer in standalone laboratories’ while Dr. Gita Nataraj, Prof. –Dept. of Microbiology, KEM Hospital, Mumbai  shared a status update on Dengue fever. On behalf of Transasia, Dr. Ameeta Joshi, Prof.- Dept. of Microbiology, JJ Hospitals, Mumbai conducted the plenary session addressing the ‘Challenges and solutions in diagnosis of Tuberculosis’. The session laid emphasis on the newer technologies, particularly in Molecular diagnostics, for TB detection. Transasia has been taking concerted efforts in this direction with its soon to be launched comprehensive portfolio for molecular testing for diseases such as HIV, TB, respiratory diseases, dengue, malaria, etc. Besides this, Transasia also introduced its new technologies in Clinical Chemistry and Immunology. XL 1000 is the latest, random access clinical chemistry analyzer with a throughput of 1040 tests/ hr. Its other key features as sample clot detection, permanent hard glass cuvettes, four channel direct ISE measurement, 3 reagent capability, simultaneous placement of up to 150 samples, among others, make it an ideal choice for high volume laboratories. ErbaQik rapid test kits for dengue and malaria were introduced by Transasia at the apt time, considering the need to contain the infections during monsoon. With a unique dual colour advantage, it is the only bi-colour detection immuno-chromatographic device. Unmatched sensitivity of > 92% and specificity of 100% for all parameters of dengue and malaria, makes it the most reliable in India today.   Additionally, Transasia also showcased its best offerings in Clinical Chemistry, Urinalysis, Coagulation and Hematology. Over 500 practicing pathologists form India and across the globe participated during the two day event making it a huge success. ]]> https://biospectrumindia.com/news/97/11131/kiht-signs-research-agreement-with-jbi.html https://biospectrumindia.com/news/97/11131/kiht-signs-research-agreement-with-jbi.html Mon, 18 Jun 2018 11:05:00 +0530 The Kalam Institute of Health Technology (KIHT), a Department of Biotechnology funded institute in the domain of medical technology policy, has recently signed an agreement with Joanna Briggs Institute (JBI), University of Adelaide, Australia. KIHT would focus on medical devices and diagnostic and associate with other JBI centres in this domain of research. All the studies done in this space would be submitted to JBI and KIHT would like to involve in supporting and leading JBI in medical devices and diagnostic space globally. AP MedTech Zone (AMTZ) will now host the JBI along with cluster of 250 manufacturing units for common facilities such as electro-magnetic interference testing, biomaterials testing, gamma irradiation, rapid prototyping centre, Indian Biomedical Skill Consortium, WHO pre-qualified cell, Directorate of Radiation and Medical Devices Promotion Council. AMTZ, now under construction in an area of 270 acres at Nadupuru in Pedagantyada mandal, is expected to roll out the first device manufactured in the zone under ‘Make in India’ initiative sometime in October. Common scientific facilities, biomaterial testing lab, 3D design, prototyping, rapid tooling facility, gamma irradiation, X-ray/CT scan tube manufacturing and other facilities will come up at the zone. ]]> https://biospectrumindia.com/news/97/11122/transasia-bio-medicals-receives-icmed-13485-certification.html https://biospectrumindia.com/news/97/11122/transasia-bio-medicals-receives-icmed-13485-certification.html Thu, 14 Jun 2018 17:15:00 +0530 Transasia Bio-Medicals Ltd., India’s leading In-vitro Diagnostic Company, has been recently certified by ICMED 13485 - Indian Certification for Medical Devices (ICMED) Certification Scheme. This is in addition to the latest ISO 9001:2015 certification. The company has been audited and registered by UL India Private Limited. ICMED is the country’s first indigenous quality assurance system for India manufactured medical devices. It is an initiative of Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). ICMED is aimed at enhancing patient safety, by providing the product credentials to manufacturers and is intended to significantly eliminate trading of sub-standard products or devices. Transasia received the ICMED 13485 certification for its manufacturing facilities at Mumbai, Daman and Baddi. All the three facilities were successfully audited for quality compliance for the design, development, manufacture, installation and service of IVD analyzers and reagents used in diagnosis. “We are glad that alongwith all existing national and international quality certifications we are now also certified by India’s very own QA system. We are committed to always deliver innovative products of the highest quality and consistent efficiency. The ICMED 13485 alongwith the latest ISO 9001:2015 certification is an assurance of our focus on continuous improvement of our systems and processes, leading to greater customer satisfaction.” said Transasia’s Chairman & Managing Director, Suresh Vazirani. He further added, “The Indian medical device industry has long needed its own quality assessment system. I am grateful to AIMED, QCI and NABCB for their joint efforts in making ICMED 13485 a reality. It a boon for IVD manufacturers like us, as it will bring down the substantial time and monetary investment to obtain globally accepted quality certifications. It will also give a boost to the ‘make in India’ focus on this industry. From the customer’s perspective, it will help in assuring standardized products.” For over three decades, Transasia has been delivering the highest quality of IVD instruments and reagents, not just in India but also globally. Infact it was the first company to attain the CE certification and enter the European market, way back in the 1990s. Over the years, Transasia has been successfully certified as compliant and adherent to all international regulatory norms, and has well established documentation and procedures.   ]]> https://biospectrumindia.com/news/97/11116/roche-encourages-use-of-nat-pcr-tested-blood.html https://biospectrumindia.com/news/97/11116/roche-encourages-use-of-nat-pcr-tested-blood.html Thu, 14 Jun 2018 11:25:00 +0530 India, with its unique situation of blood shortage for transfusion combined with reports of transfusion transmitted infections (TTIs) could be a challenge for patients to recover. It is important that patients are reassured in terms of quality of blood to be transfused. India with its large population is vulnerable and due to growing implementation of Nucleic acid testing (NAT) worldwide remains under positive pressure to adopt such cutting-edge technologies in transfusion services nationwide. It must be pointed out that NAT Polymerase Chain Reaction (PCR) testing enables early detection of infection in donated blood which enhances blood safety. Additionally, voluntary donors have been found to have lower incidence of TTIs than replacement donors. On the ‘World Blood Donor Day’ it is important to iterate that there is an urgent need for more voluntary blood donors and adoption of better screening standards such as NAT PCR. The population prevalence of Hepatitis B (HBV), Hepatitis C (HCV) and HIV in the country is about 4%, 1% and 0.26%. Only 70% of HIV infected individuals are aware about their ailment and early detection could prevent high risk behaviour thereby saving millions of lives. The introduction of NAT will significantly reduce many such infections and transfusion transmitted infections (TTIs) associated morbidity and mortality. In addition, it also positively impacts patient and Government expenditure on treatment and hospitalisation due to TTIs. In India, blood screening for HBV, HIV and HCV by serological tests for HBsAg and antibodies to HIV 1/2 and HCV is mandatory. The serononreactive blood donations are still at risk of transmitting TTIs and thus, need for a sensitive screening test arises to decrease this residual risk which has been reduced significantly over the last two to three decades in countries where NAT has been implemented. The awareness around NAT PCR is increasing in India, however, only about 9% donated blood gets screened by NAT out of 11.6 mn blood donations. Currently, NAT is not mandatory in our country for screening of TTIs. NAT PCR directly detects the genetic material (RNA & DNA) of the virus namely HIV, Hepatitis B and Hepatitis C. NAT is the most sensitive technique for detection of infections in donated blood that is currently available across the world. According to medical experts on advanced blood screening methods, NAT PCR is advisable since the window period - a time between when a patient is infected and when they show up as positive by the routine mandatory antigen/ antibody tests - is shortened. Considering the window period of detection is shorter for NAT PCR, TTIs could be reduced in recipients of NAT-tested blood. Dr. Sandeep Sewlikar, ‎Head - Medical and Scientific Affairs - ‎Roche Diagnostics India, said, “We ardently believe that safety is the basic requisite for any blood transfusion. Safe blood transfusion reassures patients psychologically in terms of quality of treatment being provided. At Roche, we have always been passionate and persistent in our efforts to introduce latest cutting-edge blood screening technologies to the Indian market. We are certain that adoption of NAT PCR testing will reduce prevalence of TTIs by detecting window period donations.” ]]> https://biospectrumindia.com/news/97/11114/amtz-receives-international-organization-award.html https://biospectrumindia.com/news/97/11114/amtz-receives-international-organization-award.html Wed, 13 Jun 2018 15:10:00 +0530 The American College of Clinical Engineering (ACCE) in collaboration with the Healthcare Technology Foundation (HTF) has conferred the “International Organization Award” to India's first medical device park Andhra Pradesh Med Tech Zone (AMTZ) during the 28th ACCE annual meeting held in California.  AP Med Tech Zone is credited to be the first Indian organization to have been nominated ever for this award and it created history by winning the 2018- ACCE international award. The award was received by Dr. Jitendra Sharma, MD and CEO, AMTZ.  ACCE – HTF International Organization Award is given to an organization outside the United States and Canada that has demonstrated significant improvements in Clinical Engineering. This award is sponsored by the Healthcare Technology Foundation on behalf of ACCE.  Founded in 1990, the ACCE is an internationally recognized professional society for clinical engineers with memberships across the globe. ACCE was established with a special focus on promoting the profession of clinical engineering in the international arena.  India is import dependent to the extent of 80% amounting to Rs. 25,000 crore per annum in medical technology sector. AMTZ has been making rapid progress by creating an innovative industrial park for manufacturing of medical devices with a holistic ecosystem for promotion of the medical technology products in India.  The initiative of AMTZ is applauded by the industry in India and medical technology experts all over the world. The AMTZ value proposition includes research and development support, avenues for technology transfer, world class infrastructure, regulatory support and access to local as well as global demand.  The zone provides manufacturers with capital intensive state-of-art scientific facilities at a very low cost, thus reducing the cost of manufacturing which will help in reducing the overall cost of healthcare delivery not just in India but globally.  The recognition by ACCE has added another feather to the cap of AMTZ which in a short span of two years has paved the path of creating various institutions like Kalam Institute of Health Technology supported by Department of Bio-technology (DBT), WHO Pre-qualification center, Directorate of Radiation Safety under Atomic Energy Regulatory Board (AERB), Indian Biomedical Skill Consortium in partnership with Quality Council of India (QCI), and Medi Valley Incubation Council under Atal Innovation Mission (AIM), NITI Aayog.   ]]> https://biospectrumindia.com/news/97/11113/innovative-automated-robotic-device-for-faster-blood-testing.html https://biospectrumindia.com/news/97/11113/innovative-automated-robotic-device-for-faster-blood-testing.html Wed, 13 Jun 2018 14:40:00 +0530 Researchers from Rutgers University, New Brunswick, US have created an automated blood drawing and testing device that provides rapid results, potentially improving the workflow in hospitals and other health-related institutions to allow health care practitioners to spend more time treating patients.   Diagnostic blood testing is the most commonly performed clinical procedure in the world, and it influences most of the medical decisions made in hospitals and laboratories.   However, the success rate of manually drawing blood samples depends on clinicians' skill and patient physiology, and nearly all test results come from centralised labs that handle large numbers of samples and use labour-intensive analytical techniques.   The research team created a device that includes an image-guided robot for drawing blood from veins, a sample-handling module and a centrifuge-based blood analyser.   Their device provides highly accurate results from a white blood cell test, using a blood-like fluid spiked with fluorescent microbeads. The testing used artificial arms with plastic tubes that served as blood vessels.   The device could provide rapid test results at bedsides or in ambulances, emergency rooms, clinics and doctors' offices.    "With our relatively simple chip design and analysis techniques, the device can be extended to incorporate a broader panel of tests in the future," said Max Balter, who led the study. ]]> https://biospectrumindia.com/news/97/11099/medgenomes-oncopept-wins-best-overall-genomic-solution-award.html https://biospectrumindia.com/news/97/11099/medgenomes-oncopept-wins-best-overall-genomic-solution-award.html Mon, 11 Jun 2018 17:05:00 +0530 MedGenome's OncoPept platform of advanced genomics-based solutions designed to accelerate cancer immune-oncology research, was named the winner of the 2018 MedTech Breakthrough Awards for 'Best Overall Genomics Solution.' OncoPept platform is used by researchers to help identify biomarkers aimed at delivering personalized therapies including more durable, improved and responsive cancer immunotherapy treatments. It offers a personalized cancer therapy approach leveraging a novel T cell receptor binding algorithm to predict personalized cancer vaccine candidates, and provides a high-throughput multi-dimensional view of the tumor microenvironment using NGS (Next Generation Sequencing) based solutions. "We thank the MedTech Breakthrough Awards for recognizing our research solutions that benefit a global community of patients dealing with various types of cancer.  As a leading genomics-based research company, it is our mission to improve health worldwide by developing deep insights into diseases, ultimately leading to treatments and – eventually – cures," said Dr. Amitabha Chaudhuri, VP, Research and Development at MedGenome. "The genomics market is incredibly competitive, and we are thrilled to recognize industry innovator, MedGenome, for their breakthrough OncoPept cancer immunotherapy biomarker platform," said James Johnson, Managing Director at MedTech Breakthrough. "MedGenome's solutions are delivering a truly personalized cancer therapy approach, and we are excited to recognize their platform as our 'Best Overall Genomics Solution' award winner in the 2018 MedTech Breakthrough Awards program." The MedTech Breakthrough Awards recognize the top companies, people, platforms and products in the health, fitness and medical technology industries today. The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the creativity, hard work and success of health and medical technology companies, services and products. With over 3,000 global nominations this year for the MedTech Breakthrough Awards, the competition was incredibly fierce. Notable winners from other categories include GE, WebMD, FitBit, Philips, 23andMe, Humana, Abbott, Apple and an impressive list of top companies and startups in the MedTech industry.   ]]> https://biospectrumindia.com/news/97/11083/cytecare-brains-hospitals-unveil-neuro-oncology-centre.html https://biospectrumindia.com/news/97/11083/cytecare-brains-hospitals-unveil-neuro-oncology-centre.html Thu, 07 Jun 2018 19:45:00 +0530 On the occasion of ‘World Brain Tumour Day’, Cytecare Cancer Hospital and Brains Neuro Spine Centre announced the launch of Bengaluru’s very own world-class ‘Neuro-Oncology Centre’ at Cytecare Cancer Hospital, Bengaluru. The Cytecare Brains Neuro Oncology Centre, under the able guidance of world famous neurosurgeon, Dr. N K Venkataramana, will have a team of highly experienced super specialists who will create the first-of-its-kind Neuro Oncology Centre in Bengaluru. The Neuropathology team, led by Dr. S K Shankar, will provide advanced pathological diagnosis coupled with immunohistochemistry to chart the appropriate course of treatment as well as prognostication. Their involvement on the tumour board case discussions will be pivotal to enhancing the treatment outcomes and quality of care. Brain tumours affect people of all ages, with 15-20% of brain tumours occurring in children, while the incident rate for adults stands at 8.2/lakh. When it comes to children afflicted by cancer, brain tumour is second only to blood cancer. Brain tumours can be benign or malignant, and can affect any portion of the brain, skull, spinal cord and vertebrae. Despite rising awareness and advances in technology, the outcome of malignant brain tumours remain dismal with an average survival rate of only 14 months.  The Neuro-Oncology centre at Cytecare, Bengaluru, will provide comprehensive services encompassing public awareness, early detection, state of the art imaging, brain monitoring and neurosurgery, supported by exclusive brain tumour research programs and the most modern technology for Radiosurgery, Neuro pathology, Radiation oncology and Chemotherapy.  Speaking on the collaboration with Brains, Dr. Selwyn Colaco, COO, Cytecare Cancer Hospital, said, “The Neuro-Oncology Centre at Cytecare Cancer Hospital is a one of a kind facility that promises to push the frontiers of gold standard Neuro-Oncology care in India. This collaboration brings together Cytecare’s specialised comprehensive Oncology care with Brains’ extensive expertise in Neurology care. I wish all the doctors associated with this facility the very best in their endeavors.” Speaking on the occasion, Dr. NK Venkataramana, Founder & Chief Neurosurgeon, BRAINS said, “Malignant Brain tumors are a critical health risk in both adult and pediatric population. Apart from providing world class treatment for all types of Brain tumors, we will also focus on prevention and innovative treatment methodologies through cutting edge research. However, identification of risk factors and creating awareness remains the fundamental goal in our pursuit of excellence.” ]]> https://biospectrumindia.com/news/97/11078/metropolis-launches-diagnostic-test-for-preeclampsia.html https://biospectrumindia.com/news/97/11078/metropolis-launches-diagnostic-test-for-preeclampsia.html Wed, 06 Jun 2018 23:25:00 +0530 Metropolis Healthcare has launched sFlt-1/PlGF ratio, a new tool for the diagnosis of preeclampsia by discriminating between preeclamptic pregnancies and other forms of pregnancy-related hypertensive disorders. Its uniqueness lies in the fact that it has been conceptualized as a simple blood test to deliver clear, reliable results with a specificity of 95 per cent and a sensitivity of 82 per cent to help identify patients at risk for potentially life threatening complications. It is believed that preeclampsia may be caused by an imbalance of angiogenic factors. It has been demonstrated that high serum levels of sFlt-1, an anti-angiogenic protein (inhibits growth of new blood vessels) and low levels of PlGF, a pro-angiogenic protein (promotes growth of new blood vessels) predict subsequent development of preeclampsia. Indians have been aware of preeclampsia over several decades. The need for developing high-accuracy diagnostic pathways have prompted doctors to start monitoring blood pressure from early pregnancy periods to ensure the close monitoring of high-risk pregnancies. ]]> https://biospectrumindia.com/news/97/11045/nipt-more-effective-in-detecting-chromosomal-disorders-in-unborns.html https://biospectrumindia.com/news/97/11045/nipt-more-effective-in-detecting-chromosomal-disorders-in-unborns.html Thu, 31 May 2018 14:50:00 +0530 A nationwide study across 10 hospitals has found that NIPT (non-invasive prenatal screening test), is much more effective, accurate and safe for detecting chromosomal abnormalities in the unborn baby, compared to conventional biochemical tests such as the double marker (first trimester) and quadruple marker tests (second trimester), as well as ultrasound studies.  The study, initiated by genomics-driven research and diagnostics firm MedGenome, had Dr. I.C Verma, Director of the Institute of Medical Genetics and Genomics at Sir Ganga Ram Hospital, New Delhi as the Principal investigator. The study, published in the Journal of Obstetrics and Gynecology of India, showed that a chromosomal abnormality detected by Non-invasive Prenatal Screening Test (NIPT) was much more likely to be true and present in the foetus, compared to conventional screening tests, authenticating NIPT to be a much more accurate testing method. India carries a heavy burden of genetic disorders. Studies suggest that chromosomal abnormalities occur with a frequency of 1 in 166 births in India, while Down syndrome (trisomy of chromosome number 21) has a high incidence rate of 1 in 800 births, resulting in the birth of 32,500 babies with Down syndrome every year in India, the highest number in the world. Early and accurate screening with NIPT can help families know about the genetic health of their baby and enable them to seek further help if necessary. Dr. IC Verma of Sir Gangaram Hospital said: “This is India’s first-ever systematic study on the non-invasive prenatal screening test (NIPT). While the efficacy of NIPT has been well proven in the more developed markets, the results of this unique study in India clearly indicate that even for Indian women, NIPT is highly accurate when compared to conventional screening tests. It is also remarkable to note that pregnancies considered intermediate to high risk through conventional screening methods were found to be low risk with NIPT. This means that a large number (96.2%) of women could potentially avoid invasive procedures such as amniocentesis and chorionic villus sampling which cause emotional anxiety and come with a risk of miscarriage (1 in 1000 for amniocentesis and 1 in 200 for chorionic villus sampling).” Stressing the importance of non-invasive screening procedures, Dr. Priya Kadam, Program Director – NIPT, MedGenome, said: “NIPT can be offered to all pregnant women and is not gestation age specific. NIPT is a great alternative for pregnancies that have received an intermediate to high risk report on conventional screening tests. The high accuracy, safety and low false positive rate, make NIPT a very worthwhile option for any pregnant woman and the test can be performed from as early as the 9th week of a pregnancy. With greater awareness and wider adoption, NIPT can significantly help reduce India’s burden of genetic disorders.” It also reduces the frequency of invasive prenatal diagnostic tests that were necessary earlier in cases where conventional screening tests showed a positive result. The study was conducted to analyze the performance of NIPT in Indian pregnant women, especially for diagnosis of abnormalities of chromosome numbers 21, 18, 13, and triploidy. NIPT screening was performed on 516 pregnancies, who had tested intermediate to high risk on conventional screening tests (Double marker, Quadruple marker test along with ultrasound studies) in the first and second trimester. The results were confirmed through invasive testing or clinical examination after birth. Over 96.2% of pregnancies were reported low risk and 3.8% tested high risk on NIPT for the conditions tested. With a small blood sample drawn from the mother’s arm, the NIPT screening test analyses DNA of the unborn baby circulating in the pregnant mother’s blood to detect chromosomal abnormalities. It has a detection rate of over 99% and a very low false positive rate of under 0.3%. In clinical settings where NIPT is implemented, a significant reduction of 50-70% in invasive procedures is observed among pregnant women, saving much pain and distress and avoidance the loss of normal babies through invasive procedures. Some of the hospitals which participated in the study include Sir Ganga Ram Hospital (Delhi); All India Institute of Medical Sciences (Delhi); Indraprastha Apollo Hospital (Delhi);Postgraduate Institute and Medical Research Center (PGI) (Chandigarh); Rainbow Hospital (Hyderabad); Amrita Institute of Medical Sciences (Kochi); Sri Ramchandra Medical College (Chennai); Jawaharlal Nehru Institute of Post Graduate Medical Education & Research (Pondicherry); CIMAR Fertility Center (Kochi); Manipal Hospital (Bengaluru), etc. NIPT is a revolutionary technology which has changed the practice of diagnosis of diseases in the unborn baby all over the world. Initially it was validated for diagnosis of abnormalities of chromosome numbers 21, 18, 13 in singleton pregnancies but has now been extended to pregnancies with twins and even IVF pregnancies with ovum donation. The scope of the test continues to be expanded and currently includes clinically relevant microdeletion syndromes such as 22q11.2 and some single gene disorders. It is also enabling prenatal diagnosis of other genetic disorders from the mother’s blood. Once fully adopted prenatal diagnosis can be provided to pregnant women in rural areas who otherwise had to travel to tertiary care centers for prenatal diagnosis, as it only involves collection of blood from the pregnant woman’s arm. ]]> https://biospectrumindia.com/news/97/11033/lifecell-launches-pentastic-pre-natal-test.html https://biospectrumindia.com/news/97/11033/lifecell-launches-pentastic-pre-natal-test.html Wed, 30 May 2018 15:20:00 +0530 LifeCell, India’s premier mother and baby diagnostics company and stem cell bank, has launched Pentastic, an ultrasound and biochemistry based blood test undertaken in the first trimester of pregnancy between 11 to 13 weeks 6 days to screen for genetic abnormalities, structural malformations in the fetus and serious high blood pressure in pregnancy. This would lead to substantial improvements in health outcomes whilst providing a higher level of reassurance for expectant parents. The screening will be performed on a platform accredited by Fetal Medical Foundation (FMF), the flagship international organisation for fetal diagnostics. Another significant advantage of the Pentastic test is that it helps in detecting Pre-eclampsia, (developing <37 weeks) in the first trimester. This is a medical condition that increases the risk both for mother and the baby during pregnancy. Some symptoms of pre-eclampsia may include high blood pressure and protein in the urine, occurring after week 20 of pregnancy. Conventional biochemical screening and even advanced DNA-based tests such as Non-invasive prenatal testing (NIPT) do not help in identifying this condition. Importantly, early detection facilitates early treatment which is important for the safety and psychology of the parents. ]]> https://biospectrumindia.com/news/97/11030/veeda-clinical-research-wins-recognition-by-assocham.html https://biospectrumindia.com/news/97/11030/veeda-clinical-research-wins-recognition-by-assocham.html Wed, 30 May 2018 11:40:00 +0530 Veeda Clinical Research, an Independent Indian CRO, has been recently honored with Best Clinical Research 2018 by the Associated Chambers of Commerce and Industry of India (ASSOCHAM) Pharma Excellence Awards held at New Delhi. Due to inventive thinking and inimitable ways, Veeda CRO has managed to attain phenomenal results. The award goes to the clinical research organization that best demonstrates an ongoing commitment to improve clinical research services in India. This award is a testimony to Veeda's commitment in supporting all stakeholders - sponsors, investigators, and patients, through highly ethical, transparent and best-in-class services. Veeda is committed to providing its clients with top level performance and execution that enhances its competitiveness in today's rapidly changing and fast growing segments of the pharmaceutical and healthcare industry. Receiving this award is a clear reflection of Veeda's success, driven by its deep scientific knowledge and service-oriented approach. The recognition corroborates the value Veeda continues to add to its clients. ]]> https://biospectrumindia.com/news/97/11023/dxterity-diagnostics-receives-ce-mark-for-the-redi-dx-test.html https://biospectrumindia.com/news/97/11023/dxterity-diagnostics-receives-ce-mark-for-the-redi-dx-test.html Tue, 29 May 2018 12:30:00 +0530 DxTerity Diagnostics has declared conformity with the requirements of the European In Vitro Diagnostic Directive (98/79/EC) and has applied the CE mark to the REDI-Dx® Radiation Biodosimetry Test for the quantitative estimation of the absorbed ionizing radiation dose after a nuclear event.   A radiological event, from the use of a nuclear weapon or improvised nuclear device, could potentially expose thousands of individuals to high or moderate levels of radiation that would require immediate medical intervention. REDI-Dx measures the biological response to radiation and provides individualized estimates of absorbed radiation from a peripheral blood sample. Physicians can use the estimate, in conjunction with radiation dispersal monitoring and clinical signs and symptoms, to prioritize the highly and moderately exposed individuals from the concerned public for medical treatment.   According to Bob Terbrueggen, CEO and Founder of DxTerity, "REDI-Dx fulfills a critical unmet need for responding to a mass scale nuclear event. It is the first CE-IVD assay for radiation biodosimetry and is designed to integrate into existing clinical testing infrastructure and read-out on the installed base of ABI 3500 Dx CE instruments."   The dicentric chromosome assay is the current "gold standard" in Europe and Asia; however, the limited testing capacity, lack of standardization, and 72-hour time to result limits its practicality. REDI-Dx overcomes these limitations with ambient sample shipping, 6-hour assay processing time, and a standardized CE-IVD kit for high throughput testing.   REDI-Dx is the result of a multi-year collaboration between DxTerity, Duke University, the University of Arizona, and Thermo Fisher Scientific; as well as patients and researchers from City of Hope Cancer Center and University of California Los Angeles. ]]> https://biospectrumindia.com/news/97/11021/mtai-welcomes-govts-plan-to-regulate-critical-care-medical-devices.html https://biospectrumindia.com/news/97/11021/mtai-welcomes-govts-plan-to-regulate-critical-care-medical-devices.html Mon, 28 May 2018 16:45:00 +0530 Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant manufacturing investments in India, has welcomed government’s plans to regulate manufacture, import and sale of critical medical devices such as pacemakers, CT scanners, X-ray machines, etc in the country.“The association believes such a decision will ensure that only high quality products will be used in the healthcare of the patients and will discourage the production and usage of sub-standard products. This has to be quickly and elaborately communicated to all the manufacturers and importers to ensure timely compliance.” “Currently many departments of the government impinge on the medical electronic device sector. This creates problem of jurisdiction as well as inter-departmental delay in decision making. For e.g. X-Ray machine suppliers need to comply with the regulations as per the Ministry of Health and Family Welfare (MoHFW), as well as the Atomic Energy Regulatory Board (AERB) at several steps, ranging from importing to operating by users. We believe implementation of these new regulations to the aforementioned medical devices, will not only erase overlapping, but will also result in less red-tape thereby helping in ease of doing business in the country.” MTaI added.It was reported in certain sections of media that on May 16th, a proposal by The Drugs Technical Advisory Board was approved to include implantable medical devices and high-end medical equipment under the purview of the Drugs and Cosmetics Act, 1940.  ]]> https://biospectrumindia.com/news/97/11018/bariatric-surgery-devices-market-to-reach-2-16b-by-2023.html https://biospectrumindia.com/news/97/11018/bariatric-surgery-devices-market-to-reach-2-16b-by-2023.html Mon, 28 May 2018 12:30:00 +0530 According to a new market research report "Bariatric Surgery Devices Market by Type (Minimally Invasive (Stapling, Suturing), Non-Invasive), Procedure (Sleeve Gastrectomy, Gastric Bypass, Revision Surgery, Adjustable Gastric Banding, Mini Gastric Bypass) - Global Forecast to 2023", published by MarketsandMarkets™, the market is expected to reach USD 2.16 Billion by 2023 from an estimated USD 1.64 Billion in 2018, at a CAGR of 5.7%.  By type, the minimally invasive surgical devices are expected to account for the largest share of the market in 2018 On the basis of type, the Bariatric Surgery Devices Market is broadly segmented into minimally invasive surgical devices and non-invasive surgical devices. The minimally invasive surgical devices segment is further subdivided into stapling devices, energy/vessel sealing devices, suturing devices, and accessories. In 2018, the minimally invasive surgical devices segment is expected to account for the largest share of this market. The high growth in this segment can be attributed to the rising obesity rates and the increasing preference for minimally invasive procedures.  By procedure, the sleeve gastrectomy segment is expected to command the largest share of the market in 2018 On the basis of procedure, the market has been segmented into sleeve gastrectomy, gastric bypass, revision bariatric surgery, non-invasive bariatric surgery, adjustable gastric banding, mini-gastric bypass, and biliopancreatic diversion with duodenal switch. The sleeve gastrectomy segment is expected to command the largest share of the market in 2018. The large share of this segment can be attributed to the advantages of sleeve gastrectomy safety, effectiveness, and affordability and limited complications as compared to other bariatric procedures. North America to dominate the market in 2018  North America is expected to account for the largest share of the Bariatric Surgery Devices Market in 2018, followed by Europe. The large share of this segment can be attributed to the rapidly growing obese population and rise in the number of bariatric surgeries. ]]> https://biospectrumindia.com/news/97/11010/medlife-launches-diagnostic-lab-in-bengaluru.html https://biospectrumindia.com/news/97/11010/medlife-launches-diagnostic-lab-in-bengaluru.html Fri, 25 May 2018 10:05:00 +0530 Medlife, a fastest growing healthcare company and largest omni-channel pharmacy, has launched its first diagnostic lab in Bangalore, as part of an aggressive plan to expand its offline footprint in India. The company has started off with Bangalore and will gradually ramp up to other metro cities in the country. As the largest e-pharmacy in India, covering over 80% of the country’s pin-code, Medlife offers customers both medicines, diagnostics and other healthcare facilities through its online portal, mobile application and customer care centres. With scalable technology and deep analytics, Medlife, in a short span, has successfully created a strong distribution network and unparalleled delivery model that has made healthcare simple, accessible and affordable to people across India. It was, thus, time to leverage these capabilities and deep learning and create a world-class offline business that provides its customers with a seamless healthcare experience. The company expects revenue of INR 200 million by the end of this financial year from the diagnostic vertical.  Medlife has already invested INR 6 Million and is planning to invest another 43 Million within the next year, to set up 6 satellite labs in addition to the centralized lab launched in Bangalore. The lab is undergoing ISO certification and will receive it’s NABH and NABL certification by FY 19-20. The diagnostic lab will operate under the name ‘Medlife Labs’. Medlife Labs also promises same day report delivery and free home sample collection to all their customers. Speaking about the company’s long-term plans, Tushar Kumar, CEO, Medlife said, “Our focus is to build a world–class infrastructure for healthcare. We, at Medlife, have constantly endeavoured to ensure quality healthcare services with affordable rates reach the maximum number of people in India.  Through our innovative tech-enabled platform, we’re building customer touchpoints across online and offline platforms that can seamlessly integrate to provide a high-quality healthcare experience for our end-users. The launch of lab services is in line with this commitment and endeavour” “Around 70 per cent of treatment decisions in India are based on lab results. Needless to say then, diagnostic services constitute one of the most critical components of medical care in India. It also helps in building a preventive care ecosystem and better diagnosis of health problems. Thus, creating substantial impact on the continuum of care,” added Kumar. The diagnostic laboratories industry in India is poised for strong growth because of rising demand for healthcare but lack of regulation remains a major concern, considering the risks it poses to patients. The diagnostic laboratories sector in India is highly fragmented with standalone centres accounting for ~ 70% of the market and organized ones having ~ 30% shares. India has around 100,000 diagnostic laboratories, which include pathology laboratories and radiology centres. Since its inception as an e-pharmacy company in 2014, Medlife has diversified into 24X7 e-consultation, laboratory services, and app-based healthcare-related services. In a short span of just over two years post-launch, Medlife went on to create a customer base of one million unique customers. The company recently launched it’s own line of generic drugs in line with the Government of India’s recent efforts to encourage the use of affordable generic drugs in India. Apart from diagnostic labs, Medlife will also be launching offline stores across 50 cities this financial year. Backed by promoters with credible experience in pharmaceutical and healthcare e-commerce businesses, Medlife is known for its best-in-class quality, 100% regulatory compliance and zero-delivery error. With a planned internal investment of $30 million to scale up operations, the company expects to earn a revenue of Rs 900-1000 crores by financial year 2019. ]]> https://biospectrumindia.com/news/97/11004/hairline-international-launches-designer-hair-restoration.html https://biospectrumindia.com/news/97/11004/hairline-international-launches-designer-hair-restoration.html Thu, 24 May 2018 11:05:00 +0530 Hairline International Hair and Skin Clinic has launched a therapy for patients of advanced hair loss called Designer Hair Restoration. Patients diagnosed with hair loss grade 5, 6 and 7 often face numerous challenges in getting a head full of hair. With Designer Hair Restoration, there is now new hope for such patients. The process involves the use of multiple techniques of hair transplant, scalp micro-pigmentation (SMP) and customized hair units to give a patient a natural look. Speaking on Designer Hair Restoration, Dr. Dinesh Gowda, Dermatosurgeon,  Hairline International Hair and Skin Clinic says, “With this process we begin with the frontal region where we do a hair transplant. The resultant growth takes around 3-9 months to be seen. During this time, to give it a little more density, we utilize SMP. This is done over 2-3 sessions with a gap of a 15 days to a month between each session. At this time, the shading and colour is matched to the transplanted hair. At the end of this time period, the transplanted hair will have grown to a level where a customized hair piece of the same colour and density is created and applied to the back of the head. The merger of all three of these elements ensures of full head of hair”. Speaking on the reasons for introducing Designer Hair Restoration, Dr. Bani Anand, Founder and Managing Director, Hairline International says, “For men with greater grades of baldness, the donor area can be of serious limitation. This makes hair transplant a problem. While the option of body hair transplant does exist, it does not yield optimum results and can be very painful. In such cases, the combined use of hair transplant, SMP and a customized hair piece is a viable option and a complete one”. ]]> https://biospectrumindia.com/news/97/10951/researchers-discover-genetic-mutation-causing-rare-colorectal-disorder-in-same-family.html https://biospectrumindia.com/news/97/10951/researchers-discover-genetic-mutation-causing-rare-colorectal-disorder-in-same-family.html Wed, 16 May 2018 12:55:00 +0530 Researchers at the Bengaluru-based genomic diagnostics and research firm MedGenome Labs have discovered a never-before-seen genetic mutation responsible for six members of a Gujarati family suffering from Familial Adenomatous Polyposis (FAP), a rare precancerous inherited condition accounting for 1-3% of cases of colorectal cancer. The mutation was also found in four other members of the family, leaving them highly susceptible to developing FAP later in life. The first-of-its-kind genetic study, conducted in collaboration with Kailash Cancer Hospital & Research Centre (KCHRC) in Goraj, Gujarat, involved a 52-year-old patient, Paresh (name changed), and his immediate and extended family of 25 people. When the patient approached KCHRC with health issues including weight loss and changes in bowel movement, doctors conducted a colonoscopy which confirmed the presence of multiple polyps (an abnormal growth that could become cancerous) in his colon, an indication of FAP. On further investigation, it was found that five of Paresh’s family members, aged 35-60 years, were afflicted with FAP. The presence of benign polyps, between 100 to 1,000 in number, appears in the colon and rectum of patients in their teenage years. If left untreated, the polyps gradually turn malignant giving rise to aggressive and often fatal colorectal cancer by the age of 40-50 years.  Since FAP is an inherited condition, MedGenome Labs together with KCHRC collected clinical data and blood samples from twenty five members of Paresh’s immediate and extended family ranging in ages 6-60 years. Genetic analysis of their blood samples revealed a never-before-reported mutation in the Adenomatous polyposis coli (APC) gene, not only in all six FAP-diagnosed family members, but also in four young individuals (ages 6-23 years) who have not yet been diagnosed with FAP. This observation has important clinical repercussions, as the four young individuals have a strong predisposition to developing polyps in later years and must therefore be kept under observation. They have thus far been counselled by MedGenome genetic counsellors and regular colonoscopies for early detection of polyps have been recommended. ]]> https://biospectrumindia.com/news/97/10949/medgenome-researchers-discover-rare-genetic-mutation.html https://biospectrumindia.com/news/97/10949/medgenome-researchers-discover-rare-genetic-mutation.html Wed, 16 May 2018 11:30:00 +0530 Researchers at the Bengaluru-based genomic diagnostics and research firm MedGenome Labs have discovered a never-before-seen genetic mutation responsible for six members of a Gujarati family suffering from Familial Adenomatous Polyposis (FAP), a rare precancerous inherited condition accounting for 1-3 per cent of cases of colorectal cancer. The mutation was also found in four other members of the family, leaving them highly susceptible to developing FAP later in life. The first-of-its-kind genetic study, conducted in collaboration with Kailash Cancer Hospital & Research Centre (KCHRC) in Goraj, Gujarat, involved a 52-year-old patient, Paresh (name changed), and his immediate and extended family of 25 people. When the patient approached KCHRC with health issues including weight loss and changes in bowel movement, doctors conducted a colonoscopy which confirmed the presence of multiple polyps (an abnormal growth that could become cancerous) in his colon, an indication of FAP. On further investigation, it was found that five of Paresh’s family members, aged 35-60 years, were afflicted with FAP. The presence of benign polyps, between 100 to 1,000 in number, appear in the colon and rectum of patients in their teenage years. If left untreated, the polyps gradually turn malignant giving rise to aggressive and often fatal colorectal cancer by the age of 40-50 years. Since FAP is an inherited condition, MedGenome Labs together with KCHRC collected clinical data and blood samples from twenty five members of Paresh’s immediate and extended family ranging in ages 6-60 years. Genetic analysis of their blood samples revealed a never-before-reported mutation in the Adenomatous polyposis coli (APC) gene, not only in all six FAP-diagnosed family members, but also in four young individuals (ages 6-23 years) who have not yet been diagnosed with FAP. This observation has important clinical repercussions, as the four young individuals have a strong predisposition to developing polyps in later years and must therefore be kept under observation. They have thus far been counselled by MedGenome genetic counsellors and regular colonoscopies for early detection of polyps have been recommended. Dr. Arati Khanna Gupta, VP – R&D with MedGenome Labs, Bengaluru said, “Once family members had consented to share their clinical histories and blood samples, we at MedGenome used high throughput Next Generation Sequencing (NGS) methods to look for the FAP causative mutant gene. Our analyses revealed the presence of a never-before-identified mutation in the APC gene in ten of the twenty five family members, six of whom had FAP. Mutations in the APC gene are commonly found in cases of FAP, causing the APC gene product to malfunction. Under normal conditions, APC is a tumour-suppressor gene which prevents uncontrolled growth of cells; a hallmark of cancerous tumours. This is the first-ever genetic study on FAP conducted in India on a large family. It underscores the power of genetic analysis in identifying individuals in the affected family at the risk of developing colorectal cancer, and saving lives through early detection and timely treatment.” Added Dr. Rakshit Shah, Surgical Oncologist, Kailash Cancer Hospital & Research Centre (KCHRC), Vadodara, who attended to Paresh and his family: “This genetic study is a breakthrough. Detection of this genetic mutation in a patient will enable us to identify individuals most vulnerable to FAP and colorectal cancer, and take preventive measures beforehand, helping bring down its incidence. Screening is the most effect way to prevent colorectal cancer. Every individual in a family or community affected by colorectal cancer should undergo genetic analysis – if they have APC gene mutation, it is likely they will develop the disease once they reach their 40’s.” This approach involving genetic analysis, is vital not only in the early diagnosis and subsequent treatment of FAP, but could also be leveraged to play a role in cancer prevention.  ]]> https://biospectrumindia.com/news/97/10941/mp-launches-portable-breast-cancer-indicating-device.html https://biospectrumindia.com/news/97/10941/mp-launches-portable-breast-cancer-indicating-device.html Tue, 15 May 2018 12:20:00 +0530 BJP MP from Hamirpur, Anurag Thakur has launched portable breast cancer indicating device and will provide machines in the Mobile Medical Units (MMU) started by him to ensure timely treatment in case of a positive result. The MMUs named Asptal – Sansad Mobile Swasthya (SMS) Seva is operational in Hamirpur district since May 1 and within a span of first eight days, the mobile hospital had 1,610 registrations and has attended 1,607 patients. This device will become an added feature of the mobile hospital that at present is conducting close to 40 tests, absolutely free of cost. Each of the Asptal has a female health worker who will be carrying out the test on patients.  MP said that introducing this device as a part of Asptal is an effort aimed in this direction. “We have dedicated women health workers as a part of our mobile hospital – Asptal who will perform this test on women, in a safe environment. I chose the occasion of Mother’s day to introduce this machine as I thought there could not be a better gift than this to all the mothers, sisters and daughters.”   ]]> https://biospectrumindia.com/news/97/10919/chinas-lepu-medical-technologis-set-to-enter-in-indian-market.html https://biospectrumindia.com/news/97/10919/chinas-lepu-medical-technologis-set-to-enter-in-indian-market.html Fri, 11 May 2018 12:15:00 +0530 China-based Lepu Medical Technology (Beijing) Co. Ltd said it is all set to make its foray into Indian medical devices and equipment market through its subsidiary, Lepucare (India) Vascular Solutions Pvt. Ltd. According to company, it is the fifth overseas subsidiary of the Chinese manufacturer, globally. Established in 1999, Lepu Medical specialises in developing, manufacturing and distribution of high-tech medical devices, equipment, mobile medical services and pharmaceuticals.  Lepu Medical vice president, Aaron Lin said India had grown into one of the prime markets for medical devices and equipment adding the demand here will far outstrip that of the current leading markets in America and Europe.  The company has presence with products in all major medical specialities including cardiovascular, neurovascular and peripheral vascular interventions, structural heart diseases, surgical cardiology, cardiac rhythm management, anesthesia and critical care, in vitro diagnostics and general surgery, the release said.  "Lepu is beginning its India operation from this month and has hired senior and experienced professionals to establish and make a mark in the market. Lepu will set up a fully functional operation organisation with 95per cent Indian employees," company said.  Their Indian office will be located in New Delhi and branch offices would be opened in other cities also, depending on the requirement.  The products being launched will be made available across the length and breadth of the country. ]]> https://biospectrumindia.com/features/97/10911/over-10-lakh-indians-diagnosed-with-liver-cirrhosis-each-year.html https://biospectrumindia.com/features/97/10911/over-10-lakh-indians-diagnosed-with-liver-cirrhosis-each-year.html Thu, 10 May 2018 14:35:00 +0530 “About 10 lakh people are diagnosed with liver cirrhosis every year in India says World Health Organization (WHO) report. While new approaches, such as stem cell therapy are being researched, currently liver transplant is the only treatment available for severe liver cirrhosis,” said Dr Dheeraj Karanth C, Medical Gastroenterologist, Vikram Hospital.   Speaking to reporters he said that sedentary lifestyles, intake of more than the permitted quantity of alcohol, having fat-filled diets, and not maintaining regular immunizations for Hepatitis B are some of the reasons for increasing liver diseases in India.   Dr Karanth further said the importance of institutes and companies taking up organ donation efforts, and to promote information about control of alcohol consumption, taking Hepatitis B vaccinations etc. According to him, technology to ensure faster diagnosis could help make transplants cheaper, and thus, efforts should make in that direction.   ‘Alambana,’ a scheme created by the Karnataka government, is one which allows people and organizations to make monetary donations to patients requiring organ transplants, which usually cost up to Rs 25 lakh. Speaking about this, Dr Somesh Mittal, CEO, Vikram Hospital said, it is a transparent scheme where the donors will know whom they are donating to. In addition, the government is also making efforts to provide free tablets, including immunosuppression drugs.   In an effort to reduce the disparity between the number of organ donors and receivers, Dr Mittal said that more than 30 doctors of Vikram Hospital have already pledged to donate their organs and hope to get other doctors of the hospital to sign up for organ donation.   While there are around 1000 patients on the waiting list for liver transplants in India, only 70 people pledged their organs between 2016 and 2017, according to Dr C. Vikram Belliappa, Consultant Surgical Gastroenterologist, quoting the recent Jivan Sarthakathai research paper. “This gap is wider than it seems, since the number of people who are on waiting lists for transplants are only those that can afford it; there are many cases that go unrecognized, “he added.   Since liver diseases are “silent killers” that are not diagnosed till much later, there is a need to go for regular health checkups, and to take regularized Hepatitis B vaccinations. ]]> https://biospectrumindia.com/news/97/10910/fitbit-launches-fitbit-versa-in-india.html https://biospectrumindia.com/news/97/10910/fitbit-launches-fitbit-versa-in-india.html Thu, 10 May 2018 13:30:00 +0530 Fitbit today announced the launch of its latest smartwatch, Versa, in India. The Fitbit Versa will be available for purchase online and offline starting May 13. The list of offline retailers includes Reliance Digital, Croma and Helios among others, while the product will be available online exclusively via Amazon India. The key features of the Fitbit Versa is female health tracking. The smartwatch in conjunction with the Fitbit app allows women to track their menstrual cycle and symptoms, making it easier to manage the same going ahead with the device getting more accurate as it gathers more fitness data. The standard edition is priced at Rs 19,999 and the Special Edition carries a price tag of Rs 21,999. Along with the Versa, Fitbit also launched a product for children called Fitbit Ace. The philosophy behind the product is to get the kids to lead a fitter lifestyle right for an early age. It prompts them to get up and move after certain time intervals, and encourages them to stay active all day, and rewards them with congratulatory messages and achievement badges for meeting their fitness goals. ]]> https://biospectrumindia.com/news/97/10905/to-make-country-filaria-free-centre-to-start-triple-drug-therapy.html https://biospectrumindia.com/news/97/10905/to-make-country-filaria-free-centre-to-start-triple-drug-therapy.html Wed, 09 May 2018 18:10:00 +0530 The Union government has approved the roll-out of the WHO-recommended new triple-drug therapy (TDT) in four select districts, including one in Maharashtra, to eliminate lymphatic filariasis (LF) from the country.   TDT, which uses Ivermectin, Diethylcarbamazine Citrate (DEC) and Albendazole, will also be rolled out in one district each in Uttar Pradesh, Bihar and Jharkhand. The studies carried out in other countries have shown that TDT is more effective than the existing two-drug therapy in permanently eliminating the micro-filariae infection. Thus, it becomes all the more important for a country like India, which bears approximately 40% of the global LF burden. In India, 650 million are people at the risk of contracting the disease across 256 districts in 21 states and Union Territories.   A senior health official from the Union health ministry said, “The Indian Council of Medical Research (ICMR) has recommended a phased introduction of TDT, following study trials by the Vector Control Research Centre (VCRC), Puducherry, which showed the safety and efficacy of the new drug therapy. It will soon be rolled out.”   Veteran epidemiologist Kapa D Ramaiah said, “Global and Indian clinical trials have shown that a single dose of triple-drug therapy cleared more than 95% microfilaria load in infected people. With such an excellent effect, annual mass TDT can eliminate LF from endemic communities in two to three years. This will enable India to effectively meet the target set by WHO to eliminate LF by 2020.”   The Maharashtra chief minister’s (CM) office sent a letter to the National Vector Borne Disease Control Programme (NVBDCP) expressing interest in rolling out TDT in the state’s endemic districts. This means that Maharashtra could well become the first Indian state to adopt the therapy and achieve the elimination of LF by 2020.   The biggest challenges on the ground include alarmingly low awareness and negligible attention given to eliminating LF in public and political discourse, experts said. ]]> https://biospectrumindia.com/news/97/10904/mri-glove-provides-clear-images-of-hand-anatomy.html https://biospectrumindia.com/news/97/10904/mri-glove-provides-clear-images-of-hand-anatomy.html Wed, 09 May 2018 17:05:00 +0530 Researchers from NYU School of Medicine have developed a glove-shaped magnetic resonance imaging (MRI) detector that can capture high-quality images of moving joints, which is published in Nature Biomedical Engineering. The study authors say their MRI glove prototype promises to become useful in the future diagnosis of repetitive strain injuries like carpal tunnel syndrome in office workers, athletes, and musicians. Because the invention shows how different tissue types impinge on each other as they move, the authors say it could also enable the construction of a more versatile atlas of hand anatomy, guide surgery with hand images in more realistic positions, or aid in the design of better prosthetics.  "Our results represent the first demonstration of an MRI technology that is both flexible and sensitive enough to capture the complexity of soft-tissue mechanics in the hand," says lead author Bei Zhang, PhD, research scientist at the Center for Advanced Imaging Innovation and Research (CAI2R), within the Department of Radiology at NYU Langone Health. MRI works by immersing tissues in a magnetic field such that any hydrogen atoms present align to create an average magnetic force in one direction in each tissue slice. These "little magnets" can then be tipped out of equilibrium by waves of electromagnetic force (radio waves). Once tipped, they spin like tops and also emit radio signals, which reveal their positions and can be rebuilt into images. Also fundamental to MRI is the ability of radiofrequency coils to convert radio waves into a detectable electric current. Unfortunately, this means that the captured ("spinning top") radio waves produce little currents inside receiver coils, which in turn create their own magnetic fields and prevent nearby coils from capturing clean signals. As all current MRI scanners measure signals that create currents in receiver coils (detectors), such coils have always been designed as "low impedance" structures that let the current flow easily. The leap made by the study authors was to design a "high impedance" structure that blocks current, and then measures how hard the force in magnetic waves "pushes" (the voltage) as it attempts to establish a current in the coil. With no electric current created by the MR signal, the new receiver coils no longer create magnetic fields that interfere with neighboring receivers, thus removing the need for rigid structures. The researchers found that their system, with the new coils stitched into a cotton glove, generated "exquisite" images of freely moving muscles, tendons and ligaments in a hand as it played piano and grabbed objects. The new study found that, in visualizing fingers as they flexed, the new coils revealed how the black bands moved in concert with the bones, which could help to catalogue differences that come with injury. ]]> https://biospectrumindia.com/news/97/10893/genetic-carrier-testing-is-the-key-to-reducing-occurrence-of-thalassemia-.html https://biospectrumindia.com/news/97/10893/genetic-carrier-testing-is-the-key-to-reducing-occurrence-of-thalassemia-.html Tue, 08 May 2018 12:10:00 +0530 On the eve of World Thalassemia Day, the scientific team at the Bengaluru-based genomic diagnostics and research firm, MedGenome Labs, stressed that ALL couples getting married should undergo carrier testing and genetic counselling routinely, and this is even more critical in the case of Thalassemia. Even as medical science strives to find a cure for thalassemia, making genetic carrier testing more prevalent among would-be parents can drastically reduce the occurrence of this inherited disease in the population. Thalassemia is an inherited (genetic) blood disorder in which the body makes a reduced quantity of haemoglobin. It is one of the leading causes of severe haemolytic anaemia amongst infants which is associated with excessive number of red blood cells being destroyed by the body, requiring lifelong multiple blood transfusions to stay alive. Thalassemia affects both males and females uniformly and is prevalent across all states in India. Marriages between close members of a family or between members of close-knit local communities is responsible for at least 3-17% of thalassemia occurrences in India. Dr. Sheetal Sharda, Clinical Geneticist with MedGenome Labs said, “Would-be parents, who are carriers of the disease, are at a greater risk of having a child with Thalassemia Major, especially if they are married to another person who is also a carrier. A couple with Thalassemia trait, have 1 in 4 chances of having a child with Thalassemia Major even if they don’t show any symptoms themselves or have no family history.” In the current Indian context, advanced genetic testing for carrier screening of parents, combined with genetic counseling, is the best way to reduce the occurrence of thalassemia in India. Genetic analysis can help the couple take informed reproductive decisions for their future married life. There is an urgent need to launch a national campaign to popularize genetic testing of ALL individuals and not only those with a family history, to reduce the healthcare burden on our society due to untreatable genetic disorders”, she added. Thalassemia is an inherited (genetic) blood disorder in which the body makes a reduced quantity of haemoglobin. It is one of the leading causes of severe haemolytic anaemia amongst infants which is associated with excessive number of red blood cells being destroyed by the body, requiring lifelong multiple blood transfusions to stay alive. Thalassemia affects both males and females uniformly and is prevalent across all states in India. Marriages between close members of a family or between members of close-knit local communities is responsible for at least 3-17% of thalassemia occurrences in India. There is no cure for thalassemia currently. Treatments include blood transfusions, iron chelation therapy (removal of excess iron from the body) and bone marrow transplant. Blood transfusions at intervals of 2-3 weeks are prescribed to patients affected with Thalassemia Major. This can be emotionally and financially draining for the family. The best solution is to prevent it from happening and all it takes is a screening test of the couple when they are planning for a family. The screening test is fairly simple and is now accessible for people across the country.   ]]> https://biospectrumindia.com/news/97/10862/van-that-detects-presence-of-tb-bacteria-is-on-the-move.html https://biospectrumindia.com/news/97/10862/van-that-detects-presence-of-tb-bacteria-is-on-the-move.html Wed, 02 May 2018 12:45:00 +0530 Collector S. Suresh Kumar of Nagapattinam has inaugurated a mobile van fitted with equipment for conducting CB-NAAT, a molecular test that detects presence of TB bacteria. The van will conduct tests for resistance to the drug rifampicin in rural and urban parts of the district till May 5. Alongside conducting tests, the health department staff will also create awareness about the ailment that affects all parts of the body, the lungs, in particular. The health department has been urging the people to get them tested for chronic deep cough and weakness of the body. The department has also been cautioning people suffering from such symptom to cover their mouths with cloth while coughing and sneezing to prevent spread of bacteria through air. The focus of the department is to convey to the public that the disease, if detected early, can be treated and cured over a continuous period of six to seven months and that the ailment was neither inherited nor a curse. Medicines were given to TB patients free of cost through primary health centers. For consumption of nutritious food, the department was also crediting ₹500 a month into the bank account of every TB patient. The initiative was aligned to the nation-wide campaign launched by the Central Government earlier this year to eradicate the ailment by 2025. ]]> https://biospectrumindia.com/news/97/10860/iit-roorkee-develops-mobile-app-to-track-heart-patients-health.html https://biospectrumindia.com/news/97/10860/iit-roorkee-develops-mobile-app-to-track-heart-patients-health.html Wed, 02 May 2018 11:40:00 +0530 Students at IIT Roorkee have developed a mobile application ‘Dhadkan’ for monitoring the health of people suffering from heart ailments and provide them with medical assistance in case of emergency. The app, developed by Computational Biology group at IIT-Roorkee, can automatically send notification to both the doctor and the patient; in case of any drastic changes in patient's health data indicating the possibility of an imminent heart attack. "Named 'Dhadkan', this mobile application will be of tremendous benefit to India which has about 10 million patients at risk of heart failure. The app is available for free and no charges are involved to avail the benefits," Deepak Sharma, Assistant Professor, Department of Biotechnology, who led the group, said. The mobile application has been designed in collaboration with experts from AIIMS. The app collects patient's data (at any desired interval) including blood pressure, heart rate, and weight, and transmits it to the authorised care-giver (a doctor, nurse or paramedic) who is linked to the patient during initial registration. "It also provides for two-way communication between doctors and patients. In addition, patients can send ECG report(s) to the doctor (if needed). The app not only eliminates the need for manual monitoring of each patient by the doctor but also helps them in proactively recommending precautionary action during the treatment period," he said. ]]> https://biospectrumindia.com/news/97/10838/indian-analytical-instrument-industry-to-reach-2-4b-eur-by-2020.html https://biospectrumindia.com/news/97/10838/indian-analytical-instrument-industry-to-reach-2-4b-eur-by-2020.html Thu, 26 Apr 2018 12:25:00 +0530 Messe Muenchen India organized a regional edition of analytica Anacon India and India Lab Expo, the market leading trade fairs for laboratory technology, analysis, biotechnology and diagnostics. This is the maiden edition which is currently being held in Mumbai from April 25-26, 2018 at the Bombay Exhibition Centre, Goregaon. The expo attracted over 4000 visitors and showcased over 100 national and international exhibitors from Germany, USA, China, Japan and Korea. The exhibition had a grandeur opening with the presence of eminent industry players like Mr. Satya Chandra Sekhar, Vice President and Head, Reliance Life Sciences, Dr. Reba Chhabra, Deputy Director Quality Control and Head, National Institute of Biologicals, Ministry of Health and Family Welfare, Government of India, Mr. Sampath Srisailam, Senior Group Leader, Syngene International Limited, Dr. Dibyendu Saha, Senior Science, Standards Liaison - Global Biologics, United States Pharmacopeia and Mr. Vijay Nag Thota, Deputy General Manager – Biologics Regulatory & Product Strategies, Hetero Drugs and Mr. Bhupinder Singh, CEO, Messe Muenchen India. The Analytical instrument industry is majorly import driven with 83% share in 2016, expected to come down to 74% by 2020 having CAGR 22% between 2012-2020 with major importing nations like China, USA and Europe, as per a recent report by Euro Asia Consulting. Indian Analytical instrument consumption is seen in key application sectors such as Pharmaceutical, Biotechnology, Testing, Inspection & Certification industry and Government & Academia. Growth of analytical instruments market largely depends on the performance and R & D spending of industries such as Pharmaceutical, Biotechnology, Chemical and Oil & Gas etc. Life sciences, Food & Beverage are also emerging as prominent sectors which are expected to fuel the market for analytical instruments in the coming years. Mr. Bhupinder Singh, CEO of Messe Muenchen India said, “Analytical Instruments industry can be made into a robust eco-system by creating competitive positioning through driving sectors’ growth, R & D, local manufacturing focus and government policies. Demand for customized instrumentation from end-user segments such as the pharmaceutical and biotechnology sectors is primarily driving the analytical instruments market in India.” India remains heavily import dependent (70-80%) to meet Analytical instruments demand, wherein high end equipment are imported, while local manufacturing is limited to basic to medium technology equipment. Analytical instrument industry is evolving with trends such as smart technology adoption, miniaturization, portable instruments and customization; customization being highly demanding by end users. Indian analytical instruments industry is emerging (2 Billion EUR) and has potential opportunities mainly driven by shifting customer focus, foreign player’s footprint and emerging application sectors. India’s pharmaceutical sector has reformed into a global R&D hub. India’s pharma industry exhibits strong manufacturing and export competencies allowing it to be one of the most competitive regions globally. The growth in Life Sciences, Pharmaceutical Research, Biotechnology, Chemical, Oil & Gas, Food & Beverage industry is fueling the consumption of analytical instrument in India. Indian analytical instrument industry is expected to reach 2.4 billion EUR by 2020 having CAGR of 17% which currently stands at 4% of global market. The Mumbai Edition of analytica Anacon India and India Lab Expo saw participation from leading companies such as Airtech Corporation, Anatek Services, Chromline Equipment, Genet Bio Co., Hally Instruments, Jiangsu Skyray Solutions Co., Ltd., Japan Analytical Instruments Manufacturers' Association, S. V. Scientific, United States Pharmacopeia, Art Lab Equipments, Simson Pharma, Waters India Pvt. Ltd. – TA, Instruments Division and Sarstedt AG & Co. KG., Agilent Technologies India Pvt. Ltd., Biolinx Lab Systems Pvt. Ltd., Glassco Laboratories Equipments Pvt. Ltd., Kevi Labtrech, India., Shimadzu Analytical (India) Pvt. Ltd., Simson Pharma, India., Toshvin Analytical Pvt. Ltd., Unichrome Associates, India. “The analytical industry is one of the smallest segments in India but is one of the most crucial industries. There is a huge opportunity for entrepreneurs to ‘Make in India’. Focus of Food & Drug Administration and Medicine & Healthcare Products Regulatory to improve safety standards. There is a necessity for entrepreneurs, government and organizations to brainstorm and invest in creating the appropriate environment.” further added by Mr. Bhupinder Singh. Analytical instruments demand to be majorly driven by technological advancement of machines, government funding, FDI in pharma along with stringent regulations resulting in steady growth. 100% FDI under the automatic route in Greenfield pharma and Pharma 2020 vision aims to make India as a global hub for end to end drug discovery. The event also had a series of conference programs focusing on in-depth discussions on the development, challenges and implementation of quality standards pertaining to bio-pharma process. Renowned speakers from Reliance Life Sciences; National Institute of Biologicals, Ministry of Health and Family Welfare, Government of India; Syngene International Limited; Global Biologics, United States Pharmacopeia; Hetero Drugs delivered key insights. The flagship edition of the trade fair will continue to take place in Hyderabad and is scheduled for September 6-8, 2018 at HITEX, Hyderabad. ]]> https://biospectrumindia.com/news/97/10824/srl-to-expand-its-diagnostic-centres-in-kolkata.html https://biospectrumindia.com/news/97/10824/srl-to-expand-its-diagnostic-centres-in-kolkata.html Tue, 24 Apr 2018 16:00:00 +0530 SRL Diagnostics will nearly double its pathology centre network in Kolkata over the next three months. The company is in the process of opening new centres across Kolkata including Kankurgachi, Kasba and Ranikuthi. The first centre in Kolkata will come up on Maniktala main road. With the launch of these flagship centres, SRL Diagnostics would have eight company-owned pathology centres in the city. The expansion in Kolkata is part of the company’s plans to improve its focus on patient care and will also involve new centres opening up across the country in the near future, the company release stated. The newly launched spacious pathology centres serve a comprehensive menu of more than 3500 tests, performed under the supervision of highly experienced pathologists, the release added. Presently, SRL carries out around 1.25 lakh tests a day across a network of 376 laboratories and a footprint spanning more than 6300 collection points. The company also has large labs in the UAE, Sri Lanka and Nepal, and about 70 collection points in various countries outside India. The company hopes to provide customised healthcare options to the residents of Kolkata.   ]]> https://biospectrumindia.com/news/97/10818/phenomenex-introduces-biozen-series-for-biotherapeutics.html https://biospectrumindia.com/news/97/10818/phenomenex-introduces-biozen-series-for-biotherapeutics.html Mon, 23 Apr 2018 12:50:00 +0530 Phenomenex Inc., a global leader in the research and manufacture of advanced technologies for the separation sciences, introduces bioZen, a new series of LC solutions for bioseparations in pharmaceutical, biopharmaceutical and academic research. The series encompasses both proven and entirely new media spanning two particle platforms; core-shell and thermally modified fully porous along with new biocompatible titanium hardware. The initial bioZen product line features seven chemistries for the UHPLC and HPLC characterization of biotherapeutics such as monoclonal antibodies, antibody-drug conjugates and biosimilars. The offering includes specific LC chemistries for the analysis of aggregates and total mAb, intact mass and fragments, peptide mapping and quantitation, and glycan mapping. As an added benefit, all bioZen media, particle sizes and phases are available in Phenomenex’s new biocompatible titanium hardware, which minimizes secondary reactions, carryover and other recovery issues to provide better overall reproducibility than stainless steel hardware. It also minimizes the amount of time typically spent on column priming and does not interfere with protein or peptide integrity. The bioZen thermally modified fully porous media is produced with Phenomenex’s proprietary post-synthetic thermal treatment process, which improves particle mechanical strength and inertness, providing significantly better peak shape and fewer unwanted secondary interactions than traditional LC media. The thermally modified media pairs well with high-efficiency bioZen Core-Shell Technology media which delivers increased resolution and sensitivity inshorter retention time windows. Both particle platforms undergo stringent QC testing to ensure consistent high quality, while all individual bioZen columns have QC protocols for specific biologic applications to confirm product performance and reproducibility.   ]]> https://biospectrumindia.com/news/97/10811/liver-function-abnormalities-more-in-north-indian-men.html https://biospectrumindia.com/news/97/10811/liver-function-abnormalities-more-in-north-indian-men.html Fri, 20 Apr 2018 15:30:00 +0530 On the occasion of World Liver day, SRL Diagnostics – a leading diagnostic chain in India – revealed that Northern states may have a higher number of undetected liver-related diseases than other parts of India. The analysis of the test results was gleaned from the four main parameters: SGPT, SGOT, ALP and Bilirubin, along with total protein and albumin.  The data is based on more than 4.24 lakh tests done at SRL Labs across India, between the year 2015 and 2017 as part of health checkups for liver function. Alanine aminotransferase (ALT or SGPT), Aspartate aminotransferase (AST or SGOT), alkaline phosphatase (ALP) and Serum Bilirubin are the major biomarkers, which are used in the diagnosis of liver dysfunction. The function of these enzymes is to help speed up (catalyze) the routine and vital chemical reactions in the liver. When liver tissue is damaged, the enzymes come out in blood. Bilirubin is a product of liver’s normal process of breaking down old red blood cells. A healthy liver can normally get rid of bilirubin, but an unhealthy one throws it back to blood. Of all the sample data analyzed, 23.38% individuals showed higher-than-normal SGPT levels while 18.72% individuals showed higher-than-normal SGOT levels, while 16.84% individuals showed higher-than-normal ALP levels. In a gender-wise analysis, men had higher abnormal SGPT and SGOT levels (28.59% and 20.99% respectively) compared to women (15.97% and 15.47% respectively). Similarly, Bilirubin levels were also higher in men (21.82%) compared to 13.45% in women. Though women reflected slightly higher ALP levels (17.18%) compared to men (16.59%). It was also observed that while younger age groups had more liver enzyme abnormalities, older groups had more of albumin and total protein abnormalities. Commenting on the same, Dr B.R Das, Advisor and Mentor - R&D, SRL Diagnostics said, “Liver abnormalities are increasing in India, because of rising obesity, alcohol abuse and liver infections. Also, liver disease is no longer restricted to age, as people below the age of 40 are also witnessing incidence of liver diseases. However, the symptoms of liver disease usually do not appear till the disease is well advanced. So, early diagnosis is the key to a better state of liver.” As per WHO (World Health Organisation), liver disease has been the most common cause of death in various countries, with India standing at number 10 in the overall ranking. There has been a paradigm shift in the dynamics of liver cirrhosis, with about 10 lakh new patients being diagnosed with it every year in India contributing markedly to the global burden of morbidity, mortality and increased death rate year-on-year. “Liver is a highly resilient organ. Hence it takes a lot of abuse before throwing up symptoms. Thus, it is imperative that regular health check-up tests are done to catch any anomaly at a relatively early stage, which will allow for easier treatment and increased chances of managing the disease with medication and lifestyle changes. This is especially true for people who live a sedentary lifestyle and do not adhere to a balanced diet regime. Preventive attitude towards health can save a person a lot of trouble in the treatment process,” adds Dr Das. ]]> https://biospectrumindia.com/news/97/10798/hitachi-to-experiment-worlds-first-urine-test-to-spot-cancer.html https://biospectrumindia.com/news/97/10798/hitachi-to-experiment-worlds-first-urine-test-to-spot-cancer.html Wed, 18 Apr 2018 12:05:00 +0530 A Japanese firm is trying to carry out the world's first experiment to test for cancer using urine samples, which would greatly facilitate screening for the deadly disease. Engineering and IT conglomerate Hitachi developed the basic technology to detect breast or colon cancer from urine samples two years ago. It will now begin testing the method using some 250 urine samples, to see if samples at room temperature are suitable for analysis. Research published earlier this year demonstrated that a new blood test has shown promise towards detecting eight different kinds of tumours before they spread elsewhere in the body. The Hitachi technology centres around detecting waste materials inside urine samples that act as a "biomarker" a naturally occurring substance by which a particular disease can be identified, the company said in a statement. The experiment will start this month until through September in cooperation with Nagoya University in central Japan.   ]]> https://biospectrumindia.com/news/97/10760/first-ai-device-for-diabetic-retinopathy-gets-usfda-approval-.html https://biospectrumindia.com/news/97/10760/first-ai-device-for-diabetic-retinopathy-gets-usfda-approval-.html Thu, 12 Apr 2018 11:30:00 +0530 The US Food and Drug Administration (FDA) permitted the marketing of the first medical device to use Artificial Intelligence (AI) to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.  Diabetic retinopathy, the most common cause of vision loss for people living with diabetes, occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye, Xinhua reported.  The device, called IDx-DR, is a software programme that uses an AI algorithm to analyse images of the eye taken with a retinal camera called the Topcon NW400, according to FDA. A doctor uploads the digital images of the patient's retinas to a Cloud server on which IDx-DR software is installed. If the images are of sufficient quality, the software provides the doctor with one of two results, either "more than mild diabetic retinopathy detected: refer to an eye care professional" or "negative for more than mild diabetic retinopathy: re-screen in 12 months." IDx-DR is the first device authorised for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care. The FDA evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites. In the study, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 per cent of the time and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5 per cent of the time. ]]> https://biospectrumindia.com/news/97/10744/health-ministry-bans-rapid-malaria-diagnostic-tests.html https://biospectrumindia.com/news/97/10744/health-ministry-bans-rapid-malaria-diagnostic-tests.html Tue, 10 Apr 2018 10:15:00 +0530 The Union Health Ministry has banned the use of ‘antibody detecting rapid diagnostic tests’ for routine malaria diagnosis due to concerns over the practicality of the approach. The antibody detection for malaria is carried out through an indirect fluorescent antibody test in patients infected with Plasmodium, which is the known causative organism of the disease. The prohibition is based on the observation that serological testing is not practical for routine diagnosis of the acute form of the disease because of the time required to develop the antibody. The testing is attributed to the persistence of antibodies even after clearance of an active infection and evidence suggests that serology only measures past exposure but does not identify existing infection. While the antibody detecting rapid diagnostic tests are preferred for their low cost and free availability, they are reported to have led to a high false positive rate in endemic areas. The ban will not impact the diagnosis of malaria sufferers as the most common tests used in diagnosis are antigen detecting rapid diagnostic tests and blood smear examination. ]]> https://biospectrumindia.com/news/97/10743/smt-successfully-wins-tenders-at-five-brazilian-hospitals-.html https://biospectrumindia.com/news/97/10743/smt-successfully-wins-tenders-at-five-brazilian-hospitals-.html Tue, 10 Apr 2018 10:00:00 +0530 SMT (Sahajanand Medical Technologies Pvt. Ltd.), India’s largest manufacturer of cardiovascular medical stents has succeeded in bagging prestigious tenders amongst Brazilian hospitals for the distribution of stents. The Indian stent manufacturer won tenders at five hospitals including the Army General Hospital, after rigorous examinations and regulatory processes. The alliance will accelerate SMT’s goal towards providing affordable and quality stents for the millions of people suffering from heart disease worldwide. Accepted widely in over 60 countries, the latest achievement comes as a landmark win. Powered by an excellent product portfolio with credible long term evidence and a stellar track record of innovation, SMT is well positioned to accept the challenges posed by the market needs of Brazil. Tenders won at the five hospitals include, the Army General Hospital, University Hospital Santa Maria, Porto Alegre, Health Secretary for State of Brasilia DF (Government Hospital in Brasilia), the University Hospital Antonio Pedro, Rio de Janeiro and the Hospital of Ministry of Education, Curitiba, Parana, Brazil. Speaking about the remarkable feat, Rahul Garud, Senior Business Manager – Brazil, International Sales, SMT, said, “It is a matter of great pride that SMT products have been accepted in all the five hospitals. Getting substantial orders from the Army General hospital and Health Secretary for State of Brasilia DF ( Government Hospital in Capital of Brazil)  after a transparent and very thorough process of evaluation gives great confidence on the quality of SMT products which are backed by Supra family of clinical data published in various index International Journals. SMT has been in Brazil for more than a decade and is now gaining acceptance at the highest level.” Mr. Ganesh Sabat, CEO, SMT said; “We continue to uphold our pledge towards saving millions, this win is a step in that direction and we are delighted with the outcome in delivering the thinnest struts of SMT stents in the South American region. We at SMT believe in long term results which have been proven in its efficacy and safety measures, used across the globe. Focused on providing patients with the best cardiac care, we continue to work on the advancement on state of the art innovations and improving our portfolio catering to our patients’ healthcare needs”. ]]> https://biospectrumindia.com/news/97/10726/mtai-suggests-gradual-rollout-of-public-procurement-guidelines.html https://biospectrumindia.com/news/97/10726/mtai-suggests-gradual-rollout-of-public-procurement-guidelines.html Thu, 05 Apr 2018 12:35:00 +0530 Medical Technology Association of India (MTaI) today said the Department of Pharmaceuticals (DoP) should prepare a road map for implementation of its guidelines on public procurement in a phased manner to enable optimum patient access to advance medical devices. “Given that India’s medical devices regulatory regime is fairly new and its implementation is nascent, any preferential provisions for public procurement applied to all segments of devices will only limit patient access and forbid several kinds of medical technology that is not locally being produced. In view of the above, we strongly urge the Department of Pharmaceuticals to carve out a road map for a phased implementation of local content requirements in order to boost local manufacturing rather than imposing local content requirements where adequate ground work for promoting localization has not taken place,” MTaI said in the press release. The DoP had issued Draft Guidelines for Implementation of Public Procurement (Preference to Make in India) Order 2017 last month. It had asked for response from stakeholders before finalizing the guidelines. In its response, MTaI has raised concerns on the implementation of preferential market access policy in the medical devices sector. “Make in India for medical devices is a long-drawn approach that will require calibrated steps for enhancement of local capacity of medical devices ranging from less advanced technology to most sophisticated ones. This journey also needs to be meticulously made organic with identification of sub-segments where enough incentives and local resource pool lie and can be garnered with the country-specific capabilities, failing which disruptions in availability and accessibility of life-saving medical devices will only hamper patient access and jeopardize patient safety. MTaI would like to extend all support in working with the government to create a road map for realizing the goal for Make in India in medical devices.”   At present, India has adequate manufacturing capabilities for products like syringes, cannulae, stop cocks, extension lines, blood bags, dressings, hospital furniture, and suction machines, but lacks the desired ecosystem for devices requiring complex research, design and engineering support, it added.   “If the government feels the dire need to implement such preferential policy, it should exempt devices that are used in critical health conditions where quality and safety cannot be compromised,” the association said. “The government should also mandate requirement of 3-year market presence and verification of financial standing of bidders in order to ensure their credibility. In this, global standards of certification / quality management and product standards such as USFDA approval / CE mark / CDSCO standards should be adhered to,” it added. It is important to note that huge costs are incurred by innovation-based companies in ensuring safety and efficacy of medical devices and therefore these costs should be considered for calculating the percentage of local content, MTaI said. “The costs are being incurred on activities like R&D, cold chain management, and maintenance in India, which generate local employment and hence should be included in calculation of local content,” the association added. MTaI said the government should also exempt all procurements by premium research institutes, teaching institutes, tertiary hospitals of Central or State Government such as AIIMS, SGPGI, PGIMER, Sree Chitra, Army Research and Referral, Railways and Defense Departments from the purview of the order. “Since the basic objective of these research Institutes and hospitals is to train the clinicians on use of medical devices, new technologies and do research on new therapies, preferential procurement provisions for such institutions will limit their reach to most latest and cutting edge technology for want of local content,” MTaI said. ]]> https://biospectrumindia.com/news/97/10707/medgenome-concludes-the-study-on-non-invasive-prenatal-testing.html https://biospectrumindia.com/news/97/10707/medgenome-concludes-the-study-on-non-invasive-prenatal-testing.html Mon, 02 Apr 2018 15:10:00 +0530 Genomics based diagnostics and research company, MedGenome along with ten other research collaborators conducted India’s first systematic study on Non-invasive prenatal screening test (NIPT). The study was conducted to analyse the performance of NIPT in Indian population at MedGenome’s CAP certified Bangalore Laboratory. The main objective was to evaluate the performance of NIPT for trisomies 21,18,13, X & Y chromosome abnormalities and triploidy in a cohort of pregnant women with intermediate to high risk on conventional screening. With a small blood sample taken from the mother’s arm, the NIPT screening test analyses cell free DNA of the fetus to detect chromosomal abnormalities. The screening test is safe and non-invasive. With a detection rate of over 99% and a false positive rate of less than 0.03 % the screening test is highly accurate. In situations where NIPT has been implemented, a significant reduction of 50-70% in invasive procedures has been observed. In the study, NIPT screening was performed on 516 pregnancies, who had tested intermediate to high risk on conventional screening test (Double marker, Quadruple marker test) in the first and second trimester. The results were confirmed through invasive testing or clinical examination post birth. Over 98% were reported low risk and 2% tested high risk on NIPT for the conditions tested. The test showed that an abnormality detected by NIPT was much more likely to be actually present and therefore authenticating that NIPT test was much more likely to truly detect abnormalities as compared to conventional screening (Double Marker test, Quadruple marker test) It is remarkable to note that those considered intermediate to high risk pregnancies through conventional screening were found to be low risk with NIPT. Meaning, a large number (98.2%) of the women could potentially avoid invasive procedures such as amniocentesis which cause emotional anxiety and come with a small risk of miscarriage. Dr. Priya Kadam, Program Director- NIPT, MedGenome, emphasizing the importance of non-invasive screening process said, “NIPT is not gestation age specific and can be offered to all pregnant women to be assured of their baby’s health. Also, due to high accuracy, safety and low false positive rate NIPT is a viable option for any pregnant woman and can be performed from as early as the 9th week of a pregnancy.” She further added, “NIPT is a revolutionary test and with increased awareness and adoption  this test can help significantly reduce our country’s genetic disorder burden. Currently, NIPT may be used in cases with high-risk results on conventional screening to avoid unnecessary invasive tests. Further reduction in cost and greater awareness would provide the benefits of this. The leading hospitals and institutes participated in the study were: Sir Ganga Ram Hospital, New Delhi, Rainbow Hospital, Hyderabad, Amrita Institute of Medical Sciences and Research Center, Kochi, Sri Ramchandra Medical College, Chennai, All India Institute of Medical Sciences, New Delhi, Post graduate institute and Medical Research Center, Chandigarh, Jawaharlal Nehru Institute of Post graduate Medical Education and Research, Pondicherry, CIMAR Fertility Center, Kochi, Manipal Hospital, Bengaluru, Indraprastha Apollo Hospital, New Delhi.   ]]> https://biospectrumindia.com/news/97/10690/tpg-manipal-buys-fortis-healthcare-chain.html https://biospectrumindia.com/news/97/10690/tpg-manipal-buys-fortis-healthcare-chain.html Thu, 29 Mar 2018 15:55:00 +0530 The Fortis Healthcare board has approved the transaction in which its healthcare division will be merged with Manipal Hospitals. Apart from it, it will also sell a majority stake in its SRL Diagnostics to the same group. Following this transaction, Ranjan Pai will become the largest investor with a 37.9% stake and TPG will follow with 20%. The promoters of Fortis Healthcare, Malvinder Singh and Shivinder Singh will have a 0.3% stake, down from about 0.8%. Each Fortis Healthcare shareholder will get shares in Manipal Hospitals in the ratio of 10.83 for every 100 held.  The Singh brothers welcomed the move, reports The Economic Times. “The demerger of Fortis’ hospital business into Manipal Hospitals, promoted by Dr Ranjan Pai and backed by TPG, will unlock significant value for all stakeholders and will further accelerate and expand access to high quality healthcare services in India,” they said in a release. “We are happy and confident that the combination will be value accretive for all stakeholders.”  In the second part of the transaction, Manipal Hospital will buy a 50.9% stake in SRL Diagnostics from Fortis Healthcare and other private equity investors at a total equity valuation of Rs 3,600 crore. This includes Manipal Hospitals buying a 20% stake from Fortis Healthcare and an additional 30.9% stake from private equity investors.  As part of the transaction, Pai and TPG will invest Rs 3,900 crore in Manipal Hospitals. The funds will be used to finance the acquisition of the SRL stake. In addition, it will support the proposed acquisition of hospital assets owned by the Singapore-listed RHT Health Trust and the growth of the hospitals and diagnostics businesses.  The Fortis brand will also be transferred to the merged company, said a person familiar with the deal. Manipal Hospitals will be a publicly traded company and Fortis Healthcare will be an investment holding company. ]]> https://biospectrumindia.com/news/97/10689/apollo-hospitals-signs-agreement-with-accuray-inc-.html https://biospectrumindia.com/news/97/10689/apollo-hospitals-signs-agreement-with-accuray-inc-.html Thu, 29 Mar 2018 15:10:00 +0530 Personalized, precise, radiation treatments will soon be available to more cancer patients in India. Accuray Incorporated has announced that the company has signed an agreement with the Apollo Hospitals Group in Chennai and New Delhi, India, for the acquisition of two Radixact Systems, radiation therapy devices that have been proven to deliver highly accurate treatments for a broad range of tumors anywhere in the body. The installation of these systems, one replacing a conventional linear accelerator and the other in a new vault, will expand access to state-of-the-art cancer treatment technology for the people of India. The orders were entered into backlog during Accuray Incorporated's Q3 fiscal quarter, which ends March 31, 2018. Apollo Hospitals was established in 1983 and has since emerged as Asia's foremost integrated healthcare services provider. This patient-centric organization's mission is to bring the highest standards of healthcare to every patient. Dr. Prathap C. Reddy, Chairman, Apollo Hospitals Group said, "Cancer care requires passionate commitment, cutting edge expertise along with unswerving dedication to keep raising the bar and at Apollo we have embraced this ethos, as our singular goal is to make cancer conquerable!" Dr. Reddy added, "For over twenty–five years, Apollo Cancer Centres have been serving patients from over 140 countries. Our fine teams of Oncologists persevere relentlessly to offer patients the global best in cancer care and a contemporary product such as the Radixact System will help our patients by minimizing the impact on their quality of life." "We are honored to be partnering with Apollo Hospitals to improve the lives of people with cancer. Our employees are focused on a common goal – to put patients first by providing them with the best possible care," said Lionel Hadjadjeba, M.D., Senior Vice President, and Chief Commercial Officer at Accuray. "The Radixact System can be used to treat virtually any tumor type including breast, head and neck, lung and prostate cancers, during every stage of the treatment journey, from primary cases, to recurrent and metastatic diseases. This gives the Apollo Hospitals clinical team tremendous flexibility and enables them to tailor treatments to the specific needs of each patient." ]]> https://biospectrumindia.com/news/97/10680/lumenis-brings-technology-for-skin-pigmentation-.html https://biospectrumindia.com/news/97/10680/lumenis-brings-technology-for-skin-pigmentation-.html Wed, 28 Mar 2018 14:00:00 +0530 Change in the lifestyle and changing latest trends have increased the demand for tattoo removals and skin rejuvenation especially among youngsters in the recent times. To address this challenge, Lumenis India have launched a technology ‘Naturalase QS’ for the first time in India. Naturalase QS’ is new advanced highest energy Q-switched system in the world and is used for skin pigmentation & tattoo removal.  ‘Naturalase QS’ can successfully treat skin rejuvenation, tattoo removal (all colors), pigmented lesions, vascular lesions and hair removal with more energy and a better beam giving more accurate and better results. The technology has been launched for the first time in India which is currently installed in Dr P.N Behl Skin Institute & School of Dermatology Hospital in New Delhi. While the other laser treatments uses small spot sizes with high energy, which results in scarring and skin pigmentation changes, Naturalase QS offered deep penetration of the laser beam into the skin yet provide better protection to the top layer of the skin. Dharmendra Mistry, Lumenis India & South Asia Country Head said “With the launch of Naturalase QS in India, there is an opportunity for those who regret their ink. People who wish to join armed forces due to strict job codes faces lot of problems to get removal of tattoos. Resultant to that many government & army hospitals could not easily address the tattoo removal cases. We are happy to announce the new innovative effective technology for the first time in India which will benefit all our stakeholders. Naturalase QS uses high energy levels, short pulse durations and wide treatments, which is more effective, quicker, safe and most comfortable treatments with better results and higher customer satisfaction, The high energy, nano quick laser pulse reaches deep into the skin where it shatters the natural or ink pigments into particles small enough to be cleared by the body’s lymphatic system” Dr Vikas Kapoor, Skin Institute & School of Dermatology, Senior Consultant said “Skin Institute is the first in the country to acquire Naturalase (Q-Switch laser). It is safe, effective, long lasting treatment for all skin problems. Naturalase is the latest technology to treat uneven skin tone, hyperpigmentation, freckles, tattoos and birth marks. This revolutionary service is a boon to dermatology. Naturalase is a powerful high energy Q-Switch laser. Confident of the results, The Skin Institute assures and offers the best at affordable prices.” Dr Poonam Sharma, Skin Institute & School of Dermatology, Senior Consultant said “Naturalase QS is an effective treatment for tattoos removal, Nevus of OTA & laser toning. There is 10-15% improvement in skin tone and visible lightening of pigmentation with each sitting. There is less downtime with the laser which adds to the patient satisfaction.” Naturalase QS technology is also known as giant pulse formation, which is a technique in which a laser is made to produce a pulsed beam. Naturalase QS offers four different wavelengths to effectively deal with a wide range of tattoo colors, on a wide range of skin types. Its four wavelengths- 1064nm, 532nm, 650nm & 585nm- target nine of the most frequently used tattoo colors ranging from light orange to dark black.   ]]> https://biospectrumindia.com/news/97/10676/axio-biosolutions-launches-indias-first-bleeding-control-awareness-campaign.html https://biospectrumindia.com/news/97/10676/axio-biosolutions-launches-indias-first-bleeding-control-awareness-campaign.html Wed, 28 Mar 2018 11:25:00 +0530 In order to create awareness and provide training on bleeding control on the lines of ‘Stop the Bleed Day’ organised in the US every year on the last day of March, med-tech company Axio Biosolutions is declaring ‘Stop the Bleed Day’ on 31st March 2018. As part of this initiative, Axio Biosolutions is partnering with major hospitals across India, including AIIMS in Delhi, Zydus Hospital in Ahmedabad, Apollo Gleneagles Hospitals in Kolkata, Kamineni Hospital in Hyderabad, and Manipal Hospital and Columbia Asia in Bengaluru. The plan is to provide an extensive, week-long training (24th–30th March 2018) to doctors, nurses and paramedic staff in using Axiostat, the company’s flagship product which is being used by Indian armed forces to stop bleeding in battlefields. 20 per cent of global deaths due to road accidents occur in India. A vehicular accident is reported every two minutes on Indian roads, and a death every eight minutes. The disheartening fact is that most of these deaths could have been prevented. Unfortunately, there is a general lack of awareness in India about controlling life-threatening bleeding - something that could save millions of lives every year. Commenting on the campaign, Leo Mavely, CEO, Axio Biosolutions, said, “The most common cause of preventable death following injury is uncontrolled bleeding. The longer someone bleeds, the higher the chance that they will succumb to their injuries. Our aim is not only to train hospital and paramedic staff on how to stop uncontrollable bleeding, but also the by-standers because accidents can happen at any time. ‘Stop the Bleed Day’ is our earnest attempt to spread awareness and save maximum lives. For, every life is precious!” Axiostat – advanced haemostatic dressing will be used free of cost to treat patients with bleeding in trauma cases on 30th & 31st March, 2018 in the partner hospitals. Even the waiting rooms of the trauma/emergency departments will be equipped to teach the public ways to control bleeding with gauze and tourniquets in case of an accident.      ]]> https://biospectrumindia.com/news/97/10658/thermo-fishers-mr-proadm-to-address-sepsis-treatment.html https://biospectrumindia.com/news/97/10658/thermo-fishers-mr-proadm-to-address-sepsis-treatment.html Mon, 26 Mar 2018 15:40:00 +0530 A new analysis of 1089 patients with sepsis and septic shock across 33 German Intensive Care Units was recently published in Critical Care by SepNet Critical Care Trials Group in collaboration with Thermo Fisher. The biomarker, mid-regional proadrenomedullin (MR-proADM), was found to add significant clinical value in identifying the likelihood of further disease progression, the earlier escalation of therapy in patients at risk of treatment failure, and the subsequent de-escalation of treatment and early discharge of low risk patients. Increased levels of Adrenomedullin (ADM) are generated in disease conditions in order to stabilize the microcirculation and protect against vascular permeability. However, the reliable measurement of ADM is complicated by its short half-life and rapid degradation. The stable fragment of the peptide, MR-proADM, allows the accurate quantification of incremental changes over the course of therapy. Recent evidence highlights the use of MR-proADM as a highly sensitive biomarker to assess disease severity in patients with sepsis with concentrations rapidly induced in the initial stages of sepsis development following burns and neurological disorders, as well as in response to invasive fungal infections in septic shock patients.   ]]> https://biospectrumindia.com/news/97/10654/aster-dm-showcases-healthcare-future-at-kerala-digital-summit-2018.html https://biospectrumindia.com/news/97/10654/aster-dm-showcases-healthcare-future-at-kerala-digital-summit-2018.html Mon, 26 Mar 2018 14:15:00 +0530 Aster DM Healthcare, with a presence in India, the Middle East and Far East, offered visitors to the Kerala Digital Summit 2018 held at Kochi , Kerala , India on the 22nd and 23rd of March 2018 , a vision of the future of healthcare. Visitors to Aster DM Healthcare’s booth at the summit have taken on a journey through a ‘Time Tunnel’ into a future of healthcare that is augmented and enriched by technology. The booth showcased the digital evolution that is set to transform the healthcare industry with telemedicine and remote monitoring that is beginning to make its presence felt today to the future with wearable technology, nanotechnology and more! Dr. Azad Moopen, Chairman and Managing Director, Aster DM Healthcare said, “At Aster DM Healthcare, it has always been our endeavor to build a future-ready healthcare system that is agile and prepared to embrace the change that technology brings to medicine. Our hospitals have always lead in adopting path breaking technological innovations for the benefit of the patients. From Hospital Information Systems reshaping the way healthcare is delivered to the Da Vinci Robotic Surgical System allowing minimally invasive surgery with 3D vision, Aster has been at the forefront when it comes to bringing advances in healthcare to the clinic. We are glad for this opportunity to showcase our vision for the future of healthcare at the Kerala Digital Summit.” The healthcare industry drives rapid innovation in advancement in patient care which will transform the way medical care will be provided in the near future. This is also reflected in development of business solutions which can encourage investment in and ensure the long-term growth of the healthcare industry. Dr. Harish Pillai, CEO - Aster Hospitals and Clinics, India. said, “Science and engineering will play a vital role in changing the face of healthcare. As society transits to a digital age, this will impact and change the way patients interact with healthcare institutions, and how they access the best of healthcare by the click of a button through connected healthcare and social care solutions. Our booth at the Kerala Digital Summit, ‘Time Tunnel’ showcases the cutting-edge initiatives that herald the Digital Evolution in Healthcare industry and gives visitors, including medical professionals, entrepreneurs, academicians and other stakeholders from across the globe, a chance to ‘live’ the future of healthcare!” Aster DM Healthcare booth was built in the form of Time Tunnel that uses futuristic design taking visitors through the future of healthcare. They first experience Telemedicine and Virtual Clinic in the year 2020 with a live display of a Patient Cart and a Virtual Reality Experience Zone that showcases Telemedicine. They then experience a Virtual Clinic with Aster Infinite, an app that integrates appointments, prescription, remote monitoring using telemetry devices and promotes wellness. They then move on to 2025, a VR (virtual reality) experience zone that showcases how wearable technology will change the healthcare experience. The zone also highlights technologies like Scan Devices and Mirrors, 3D printing and organ tissue development where exciting developments are taking place today. Zone 2030 showcases technology that has the potential to disrupt and redefine the healthcare industry in the next decade. This includes Nanotechnology, Cognitive Computing and Robotic Surgery using Hololens. Visitors can experience Nanotechnology through an exciting VR engagement where they can experience the use of nanotechnology in cancer by using a laser gun to shoot cancer cells in the blood stream.   ]]> https://biospectrumindia.com/news/97/10655/mtai-suggests-measures-to-ensure-medtech-growth.html https://biospectrumindia.com/news/97/10655/mtai-suggests-measures-to-ensure-medtech-growth.html Mon, 26 Mar 2018 14:15:00 +0530 Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant investments in Manufacturing in India, states that broad-brush criteria for public procurement will cause proliferation of manufacturing of low quality products in India while high quality components retain their axis abroad.At present, India has got adequate manufacturing capabilities for products like syringes, cannulae, stop cocks, extension lines, blood bags, dressings, hospital furniture, and suction machines, but lacks the desired ecosystem for devices like heart lung machines, pacemakers, complex catheters, etc.“Unlike several other sectors, medical devices are comprised of thousands of very varied products in engineering and design complexity. A uniform 25-50% local content ask, preceding any meaningful scaling up of the missing sophisticated component ecosystem will create a risk of ‘garage manufacturing’ with low cost – low quality Chinese knocked-down kits based assembly.” MTaI Director Mr. Probir Dassaid at a press conference.“This is compounded by the fact that India’s medical devices regulatory regime is new, the rules and their implementation is nascent, and the country’s materio-vigilance programme will take time to scale up. Any preferential provisions for public procurement at this stage must only be limited to products where India has existing manufacturing capacity. The capacity should be validated by credible third parties like PWC & KPMG,” he added.MTaI Chairman and Director General Mr. Pavan Choudary said MTaI members applaud the government’s Ayushman Bharat initiative and are committed to support all initiatives that ensure growth of the sector.“But somewhere there is an over-simplification of a complex problem. Measures like price capping and preferential market access without taking into account the complexity of the sector are going to create obstacles in realization of ‘Make in India’ goal,” Mr. Choudary said. “This year the FDI in medical devices was clearly pipped to cross USD 1 billion, thanks to this government’s move of bringing it on the automatic route. However, it has dipped to just USD 184 million. Why did the FDI lose it trajectory of growth is what the government should ask,” He added. (See attached enclosure)Mr. Das said, “It has clearly been evidenced that the arbitrary price control mechanism has created uncertainty among global MedTech majors about India. This weakening sentiment is certainly counterproductive to Make in India. Also, the growth of the high quality, organised private hospital segment in India was on the back of the availability of globally the best/innovative products. If the same products exit India, there will certainly be a shrinkage of the organised private sector healthcare. This will have a detrimental effect on the market size, and thus on Make in India.”MTaI Director Mr. Sanjay Bhutani said that trade margins should be rationalised on the basis of price to trade in case of imported products and price to distributor in case of locally manufactured products. “Different medical devices have different market adoption investment requirements (e.g. a hypodermic syringe may not have the same physician training investment needs as a trans-catheter heart valve). Therefore, different marketers require different levels of profitability that is both fair and logical. Hence, TMR should be based on Price to Trade, which takes into account investments in training, localisation R&D, government taxes and surcharges.”“If TMR is based on landed cost in case of imports none of these intermediate costs would be accounted for and the whole ecosystem would lose money, which is detrimental for the overall health of the sector. Similarly ex-factory cost as a starting point for domestic manufacturers is prone to huge manipulation as observed by the CDSCO. If the government still chooses to base margins on cost, it should consider landed cost for imported products and standard cost for locally manufactured products to create a level-playing field for all players,” Mr. Bhutani added.Landed cost for importer and standard cost for local manufacturer are equitable as all sales & marketing expenses, general overheads, inventory cost, training, demo, interest cost, taxes, etc. are incurred post landed cost and standard cost.In summary, MTaI suggests the following to achieve the objective of quality healthcare delivery in the country and simultaneously encourage Make in India for medical devices: MTaI strongly believes that the visionary and powerful programme of ‘Ayushman Bharat’ should focus on the longest pending area of Indian healthcare -- Healthcare Access through a Healthcare Financing Model. When compounded with value-based care and pricing, this will create a strong tailwind for Make in India, not price controls. MTaI supports recommendations of The Committee on High Trade Margins, which is under the consideration of the Department of Pharmaceuticals. The report has asked for Trade Margin Rationalisation (TMR) from the level of Price to Trade or Distributor. Once implemented, this will significantly reduce MRPs and yet keep innovative, high quality products available for all sections of Indian patients.  a. TMR should be based on Price to Trade / Distributor, which takes into account investments in training, localisation R&D, government taxes and surcharges, etc. b. If TMR is based on landed cost in case of imports or manufacturing cost in case of local manufacturing, none of these intermediate costs would be accounted for and the whole ecosystem would lose money, which is detrimental for the overall health of the sector. c. Ex-factory cost as a starting point for domestic manufacturers is prone to huge manipulation as observed by the CDSCO. Instead of ex-factory cost, standard cost should be taken into account which makes it equitable with landed cost. d. If margins are based on cost, it should consider landed cost for imported products and standard cost for locally manufactured products to create a level-playing field for all players. e. Any preferential provisions for public procurement at this stage must only be limited to products where India has existing manufacturing capacity. The capacity should be validated by credible third parties like PWC & KPMG. ]]> https://biospectrumindia.com/news/97/10652/metropolis-to-expand-with-800-centres-and-10-labs-.html https://biospectrumindia.com/news/97/10652/metropolis-to-expand-with-800-centres-and-10-labs-.html Mon, 26 Mar 2018 12:45:00 +0530 Metropolis Healthcare Limited operates a chain of diagnostic centers and hospital laboratories in India, the United Arab Emirates, Sri Lanka, South Africa, Kenya, Mauritius, and Ghana. The company is planning to add 800 collection centres and around 10 laboratories by the end of next fiscal, said Ameera Shah, Metropolis Healthcare Promoter and Managing Director. The company currently has 150 labs with 1,800 collection centres and processes over 4,500 varieties of tests. As part of the company's growth strategy, it would expand its geographical presence in North and Eastern parts of the country while growing depth in South and West, she added. During the last year, the company has set up labs in Ludhiana, Khanna, Ghaziabad, Dhanbad. We have also added labs in Kolkata, Patna and Delhi, she added. About the southern and western regions of the country, Shah said: "We are very clear leaders in West and South. Here we have to build much more depth. We are going deeper and nearer to the patients." "In Africa we will keep growing, we are looking to enter one or more countries there." Shah said on expansion of company. The interest is now on building dominance and market leadership in the places that the company is present, she added. Shah said: "Expansion will be done through internal accruals. We are also planning to invest around Rs 60 crore over the next two to three years in technology." The company had entered a public-private partnership three months ago with National Aids Control Organisation (NACO) for a three-year project to organise collection of blood and testing for HIV at 560 locations across India. Metropolis Healthcare conducts more than 30 million tests a year catering to over 20,000 laboratories, hospitals, nursing homes and 2 lakh consultants. It offers comprehensive testing in the areas of genetics biochemistry, molecular oncology, anatomic pathology, microbiology, haematology, immunochemistry, among others.   ]]> https://biospectrumindia.com/news/97/10648/revolutionary-drug-test-uses-fingerprint-detection.html https://biospectrumindia.com/news/97/10648/revolutionary-drug-test-uses-fingerprint-detection.html Fri, 23 Mar 2018 16:05:00 +0530 A fingerprint test published in AACC's Clinical Chemistry journal can tell whether someone has taken heroin or cocaine, and accurately distinguishes between drug users versus individuals who were exposed to drug residue in the environment. This breakthrough study brings fingerprint drug testing one step closer to clinical adoption, which could revolutionize drug testing by making it both simpler and nearly impossible to cheat.  Traditional drug tests have many limitations, though. Blood tests, for example, are invasive and require trained staff to collect samples, urine test samples are extremely easy to adulterate, and saliva tests—though noninvasive and more tamper-resistant have a short window of detection. A team of researchers led by Melanie Bailey, PhD, of the University Of Surrey, U.K. developed a test that overcomes these issues by using a fingerprint to detect cocaine use. With this latest study, Bailey's team has improved on their 2017 test by developing a new fingerprint test protocol for both cocaine and heroin that uses the gold standard drug testing method, liquid chromatography-mass spectrometry (LC-MS), and that is minimally impacted by environmental contamination.  To develop this method, Bailey's team collected fingerprints before and after handwashing from 50 non-drug users and from 25 individuals who testified to taking either cocaine (13) or heroin (12) in the past 24 hours. The researchers took corresponding saliva samples for comparison. Additionally, to make sure the method accounted for environmental contamination, the researchers collected a third set of fingerprints from the non-drug users after they shook hands with the drug users. After analyzing the fingerprints with LC-MS for both heroin and the heroin metabolite 6monoacetylmorphine, the researchers found that this protocol identified 100% of heroin users even after handwashing and only gave a false positive for one non-drug user who shook hands with a drug user. The researchers also used LC-MS to test for cocaine and its metabolite benzoylecgonine, which identified 85% of cocaine users after handwashing and produced no false positives for the non-drug users who came in contact with drug users. Significantly, for both heroin and cocaine the fingerprint test correctly identified more drug users than saliva testing. The test could help bring about a huge change in drug testing and diagnostic sector and ultimately leads major contribution in healthcare industry. ]]> https://biospectrumindia.com/news/97/10645/roche-launches-immunoassay-for-zika-virus-detection.html https://biospectrumindia.com/news/97/10645/roche-launches-immunoassay-for-zika-virus-detection.html Fri, 23 Mar 2018 14:25:00 +0530 Roche has launched the first fully automated Zika IgG immunoassay to help detect Zika virus infection. The diagnostic test is called the Elecsys Zika IgG immunoassay and will be available in CE Mark countries. As diagnostic testing enables healthcare professionals to assess the immune status of patients, Roche’s immunoassay will be of particular importance to expectant mothers, their partners and travellers in order to detect evidence of a recent Zika virus infection. This new assay is part of a significant advancement from Roche for Zika virus screening. In 2017, the US Food and Drug Administration (FDA) granted IVD status to the cobas Zika test, for use with the cobas 6800/8800 systems, for the screening of blood and plasma donations in the US. The rapid development of assays, including cobas Zika NAT and Zika IgG antibodies, was part of the company-wide response to the World Health Organisation’s declaration of a public health emergency during the Zika epidemic in 2016. ]]> https://biospectrumindia.com/news/97/10641/fortis-hospital-launches-cancer-care-institute.html https://biospectrumindia.com/news/97/10641/fortis-hospital-launches-cancer-care-institute.html Thu, 22 Mar 2018 15:20:00 +0530 Fortis Hospital Shalimar Bagh, Delhi has added a dedicated cancer care wing to its current array of specialties. The institute brings together experienced cancer care specialists backed with the latest technology under one roof. It aims to reduce the impact of cancer burden in the state by allowing for early screening and detection, thereby reducing late - stage diagnosis and mortality. Fortis Cancer Institute, Shalimar Bagh has a comprehensive cancer care program that follows a trans-disciplinary and multi-modality approach in the field of Oncology/Cancer. It offers Medical, surgical and radiation oncology services along with bone marrow transplant treatment. The Nuclear Medicine and Interventional Radiology for Diagnostic and Therapeutics services provides multidisciplinary approach in cancer management.  The center is equipped with cutting-edge Radiation Therapy technology (VERSA HD) with world-class Monaco Treatment Planning System capable of delivering therapies such as SRS, SBRT and SRT VMAT. Along with these, other radiation therapies such as 3D CRT, IMRT, IGRT are also available. In addition, the institute is equipped with Discovery GE HD PET-CT, which provides crucial information regarding the stage of cancer and planning of radiotherapy. Medical Oncology, Chemotherapy Day Care, Head & Neck, Breast & Thoracic Oncology, Brain and spine Tumour Surgery, Endoscopic & Laparoscopic GI Cancer Surgery, Genito Urinary Onco Surgery, Haemato Oncology and Bone Marrow Transplant, Gynae Oncology, Radiation Oncology, Nuclear Medicine - PET CT Scan and Interventional & Therapeutics Radio diagnosis are some of the services provided in the institute. Dr. Surender Dabas, Director, Surgical Oncologist said, “Head and neck cancers are a significant problem in our country constituting approximately one-third of all cancer cases in contrast to 4–5% in the developed world. In India, majority of cancers present as locally advanced Stage III/IV disease. While most efforts usually focus on therapy and outcomes, the need for early detection cannot be overlooked. The high incidence of head and neck cancer in India is a consequence of widespread use of tobacco.” Dr. Sunil Kumar Gupta, Director, Medical Oncology said, “Cancer occurs whenever a fault or a mutation happens in a gene. The improved understanding of various genes responsible for causing certain cancers has triggered the discovery and development of targeted therapies. The various translational and targeted approaches for cancer management are being explored in the form of monoclonal antibodies, EGFR inhibitors, anti-angiogenesis, proteasome inhibitors, tyrosine kinase inhibitors, farnesyl transferase inhibitors, gene therapy and immunotherapy etc. The improved understanding of cancer genetics is also helping in predicting the response of therapies in certain cancer types.” Dr. Pradeep Jain, Director, GI Oncology said, “Gastrointestinal cancers are on the rise in India. They are deep seated and advanced in stage by the time they develop symptoms. To catch them early we have to be vigilant for symptoms and get investigated by the specialists at the earliest. They are curable and we provide you the opportunity. In Fortis hospital we treat these cancers by adopting a minimally invasive technique which has a high cure rate, early recovery and good quality of life.” Mahipal Singh Bhanot, Facility Director said, “At Fortis we offer holistic care be it diagnostics, interventional or surgical procedures. The Fortis Cancer Institute offers a complete array of medical oncology, surgical oncology and radiation oncology services. The aim behind opening the institute is to offer the patients a platform for early diagnosis and treatment. The institute has experienced cancer experts with latest technology and offers complete range of cancer treatments.” Cancer is one of the leading causes of morbidity and mortality worldwide. It is estimated that every year 14.1 million people are diagnosed with cancer translating to 8.2 million deaths. 57% (8 million) of new cancer cases, 65% (5.3 million) of the cancer deaths and 48% (15.6 million) of the 5-year prevalent cancer cases occurred in the less developed regions. India had 1.01 million new cancer cases and 0.68 million cancer deaths in the year 2012. The number of new cases is expected to rise by about 70% over the next 2 decades and it is the second leading cause of death globally. Globally, nearly 1 in 6 deaths is due to cancer. Around one third of deaths from cancer are due to the 5 leading behavioral and dietary risks: high body mass index, low fruit and vegetable intake, lack of physical activity, tobacco use, and alcohol use.   ]]> https://biospectrumindia.com/news/97/10630/samsung-initiates-smart-healthcare-project-in-andhra-pradesh-.html https://biospectrumindia.com/news/97/10630/samsung-initiates-smart-healthcare-project-in-andhra-pradesh-.html Wed, 21 Mar 2018 12:55:00 +0530 Samsung India has initiated Samsung Smart Healthcare program at King George Hospital in Visakhapatnam to provide affordable and quality healthcare to financially and socially backward patients. As part of the program, Samsung has provided advanced and innovative healthcare equipment such as digital ultrasound and digital x-ray manufactured by the company free to select government hospitals across the country. The Samsung Smart Healthcare facility in Visakhapatnam was inaugurated by G. Srijana, IAS and Joint Collector, Vizag. Samsung Smart Healthcare is Samsung India's flagship citizenship initiative in the healthcare space. Samsung Smart Healthcare program aims to support the Government's efforts to benefit communities with limited access to quality healthcare. With innovative products such as digital ultrasound, digital x-ray and accessories that facilitate healthcare intervention and multiple medical examinations, since 2015, Samsung has collaborated with 16 government hospitals across to country for the Samsung Smart Healthcare program. Until now, Over 3.5 lakh patients from economically and socially weaker sections of society have benefitted from the Samsung Smart Healthcare program. Doctors, technicians and radiologists are also trained to handle state-of-the-art diagnostic equipment and software. ]]> https://biospectrumindia.com/news/97/10603/igenomix-launches-synchrony-to-make-ivf-successful.html https://biospectrumindia.com/news/97/10603/igenomix-launches-synchrony-to-make-ivf-successful.html Thu, 15 Mar 2018 18:25:00 +0530 At present IVF no doubt has proven to be successful, as due to this fertility treatment hundreds of thousands of children are born yearly world over. It reinstates hope, optimism and patience in an infertile couple who are facing challenges conceiving, hopping doctors and fertility experts to know the root cause of infertility. IVF provides a sense of security because they know they have a last resort which they can bank upon! But at times the dream of becoming a parent through this treatment might not always work. For all those aspiring mothers who feel empty, lonely and incomplete and are having a harrowing experience with failed IVF cycle, your biological clock is ticking at a faster pace now; and hard luck with IVF is boosting your anxiety levels. According to the estimate of World Health Organization (WHO) about 8-10% of couples experience some form of infertility. A growing problem in India since the last decade, infertility is a complex and upsetting experience and people undergoing IVF often face more stress worrying about the success rate. Igenomix brings a new solution, a new genetic technique “Synchrony”. This path breaking new product, brings the advantage of Endometrial Receptivity Analysis (ERA) and Preimplantation Genetic Screening (PGS) together to help IVF specialists achieve a successful pregnancy for their patients. “The success of IVF depends on a lot of factors such as the age of the woman, the quality of the embryo, status of the uterus etc. But the two principal factors to consider for maximizing the chances of implantation during an IVF treatment are a chromosomally normal embryo and a receptive endometrium. If both the embryo and the endometrium are synchronized, the IVF clinician can transfer the right embryo at the right time. Combining IGENOMIX ERA and PGS allows covering the two key factors to achieve your goal, a healthy baby at home.” Says Dr. Rajni Khajuria, Lab Director at Igenomix. Analyzing and detecting the window of implantation is really important so as to prevent implantation failures. Due to lack of accurate methods of assessment, endometrial receptivity (ER) is not usually investigated in an infertile patient or even before in-vitro fertilization (IVF). Endometrial tissue is a receptive lining in the uterus which is integral to the successful pregnancy. Since long, endometrial tissue was checked through ultrasound. ERA is the latest discovery to assess the endometrial receptivity. ERA is a state-of-the-art diagnostic method, developed and patented by Igenomix in2009. The development of this diagnostic technique is based over the 10-year of research. ERA determines whether the woman is receptive on the day, when the biopsy is performed. If the result is positive then that is the window of implantation for that particular patient. Even after a successful implantation there are many cases where the pregnancy endsup in a miscarriage in the first trimester. This mostly occurs due to chromosomalabnormalities in the embryo. Over 50% of spontaneous miscarriages are caused bychromosomal abnormalities. IGENOMIX’s PGS with the added advantage of MitoScore enables pregnancy rate by 70-80% by a single embryo transfer. PGS uses the latest next generation sequencing(NGS) technology to screen the embryos for chromosomal abnormalities of all 24chromosomes, hence increasing the chances of conception by 60% through IVF. So time to overcome your stress and advance your chances of IVF success and pregnancy. Take an optimistic step forward towards motherhood with Synchrony! ]]> https://biospectrumindia.com/news/97/10578/csir-igib-to-commercialise-its-genetic-tests.html https://biospectrumindia.com/news/97/10578/csir-igib-to-commercialise-its-genetic-tests.html Sat, 10 Mar 2018 17:20:00 +0530 The Council of Scientific and Industrial Research’s Delhi-based Institute of Genomics & Integrative Biology (CSIR-IGIB) has decided to commercialise a set of 27 genetics tests it has developed over the years. The institute has entered into an agreement with Dr Lal PathLabs, which has a large network of diagnostic centres across the country, for licensing the genetic tests. These tests are expected to be launched in phases over the year. With its rich expertise in the area of genomics and a wide network of clinical partners across the country, IGIB has also embarked on a unique outreach programme. Called GOMED (Genomics and other Omics technologies for Enabling Medical Decision), the programme provides a platform for clinicians to tap into the rich and varied expertise of CSIR-IGIB in disease genomics to solve clinical problems. The project is funded through the Fast-Track Translation (FTT) Research Programme of CSIR. ]]> https://biospectrumindia.com/news/97/10550/amtz-and-tuv-partner-for-one-stop-shop-solutions-of-medical-devices.html https://biospectrumindia.com/news/97/10550/amtz-and-tuv-partner-for-one-stop-shop-solutions-of-medical-devices.html Tue, 06 Mar 2018 17:45:00 +0530 Andhra Pradesh MedTech Zone (AMTZ) is selected by TUV Rheinland India to pursue its Make in India programme by investing in production facility within the complex. During the recent CII Partnership summit, Andhra Pradesh chief minister Chandrababu Naidu, honored TUV Rheinland India with the concessionaire agreements of both EMI/EMC & Electrical Safety and Bio-material scientific projects. The company had signed an agreement and entered into a partnership with AMTZ last year to set-up a comprehensive state-of-the art facility providing one-stop shop solutions for a wide variety of medical devices. The facility will have a 5 meter measurement table with 5 tonnes capacity Electro-Magnetic Interference (EMI/EMC), Electrical Safety & Biomaterial scientific facilities. It will also include one 10m Semi Anechoic chamber with a measurement range upto 40GHz, two 3m semi Anechoic chamber with a measurement range upto 40GHz, precision acoustics facility for measuring sound pressure and sound power from medical devices and many other testing facilities within the zone.  AMTZ will house modern 250-300 independent manufacturing units, each over a built-in ready to use area at a very cost effective long-term lease. In addition the park will have in-house high investment scientific facilities, including state-of-the-art testing laboratories, which would help manufacturers significantly reduce the cost manufacturing thereby creating world class diagnosis with quality products accessible to the common man at affordable prices.  complete medical equipment ecosystem under one roof of AMTZ would reduce the overall product developmental lifecycle, logistics charges and turnaround time to market thereby reduction in cost for total healthcare. ]]> https://biospectrumindia.com/news/97/10548/mtai-disapproves-self-regulation-proposal-of-aisnma.html https://biospectrumindia.com/news/97/10548/mtai-disapproves-self-regulation-proposal-of-aisnma.html Tue, 06 Mar 2018 15:45:00 +0530 Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant investments in India, is not in favour of self-regulation of syringe prices as proposed by All India Syringes and Needles Manufacturers Association (AISNMA) as it is not a viable solution for enabling patient access to advance medical technology products. The association believes such a decision should be implemented by all stakeholders after proper consultations. MTaI said the methodology recommended in the Report of The Committee of High Trade Margins in the Sale of Drugs, which is being evaluated by the Department of Pharmaceuticals, is the best way to regulate the trade margins. According to the report, trade margin is the difference between Price to Trade (the price at which the manufacturer or marketing company sells the drug to the distributor or stockiest) and the MRP. The report adds that “the government should consider capping the overall trade margins, thus, giving a level playing field to every trade channel. Industry should have the liberty to decide intra-trade channel percentage,” the report adds. “Our members companies support rationalization of trade margin as recommended in this report. Moreover, there is no direction from NPPA to rationalize trade margins on syringes by 75% as averred by some," MTaI said in a press release. “In the absence of government’s directive, any self-regulation will not be industry wide and would bring new tilts and distortions”, MTaI added. The association said its member companies offer a diverse portfolio (imported and locally produced) of medical devices and not one single product like syringe or needles. “Following different self-regulation mechanisms for different set of products would become a gigantic task,” it stated.  MTaI also asked for consideration of manufacturing standards of its members vis-à-vis domestic companies. “Any regulation should not just hinge on the pricing of a particular category while ignoring considerable divergence on good manufacturing standards”, it said. The association said that its member companies are committed to enhancing patient access to quality products and seek the undiluted implementation of the DOP report on trade margins. ]]> https://biospectrumindia.com/news/97/10528/hdfc-invests-in-medgenome-to-complete-series-c-funding-of-40m.html https://biospectrumindia.com/news/97/10528/hdfc-invests-in-medgenome-to-complete-series-c-funding-of-40m.html Mon, 05 Mar 2018 13:10:00 +0530 MedGenome Labs Ltd., the leading genetic diagnostics company in India, announced investment by HDFC Ltd., HDFC Life and HDFC Asset Management to complete its Series C funding of $ 40 million. MedGenome will utilize this capital to expand the clinical genomic testing market by penetrating all the Tier II and Tier III cities and democratize the critical genetic tests like noninvasive pre-natal screening (NIPT) and new born genetic testing.  The company plans to establish more genetic centers in hospitals across the country to support clinicians and to enable patients to take informed decisions. MedGenome has completed over 100,000 genomic tests and supported clinicians in diagnosing more than 40% unresolved cases. About 6% of the children born in India have inherited pediatric diseases which is double the worldwide occurrence rate. "We believe understanding genetic information can have a big impact on Indian healthcare industry through early detection of disease risk and development of new medicines. We are very happy to see an Indian company take a lead in a deep technology area like genomics and have decided to support MedGenome in its endeavor to make genetic tests affordable and accessible widely." said Mr. Deepak Parekh, Chairman, HDFC Group. "MedGenome’s goal is to significantly reduce the burden of inherited diseases in India and assist clinicians in implementing precision medicine. We are excited about partnering with HDFC to increase adoption of genomics across India." said Sam Santhosh, Founder and Chairman of MedGenome. MedGenome operates the largest CAP-accredited Next Generation Sequencing (NGS) lab in South Asia. MedGenome's diagnostics tests include many breakthroughs for genetic diagnostics including the first proprietary liquid biopsy (OncoTrack) for monitoring cancer treatment, non-invasive prenatal screening test (NIPT) for pregnant women, carrier screening for couples planning for children, and whole exome sequencing for cost-effective identification of rare mutations.    ]]> https://biospectrumindia.com/news/97/10525/diabetomics-launches-manufacturing-facility-in-hyderabad.html https://biospectrumindia.com/news/97/10525/diabetomics-launches-manufacturing-facility-in-hyderabad.html Mon, 05 Mar 2018 10:25:00 +0530 DiabetOmics, a global medical diagnostics company that is developing the world’s first patented non-invasive, saliva-based diabetes monitoring test has opened its first manufacturing facility in Hyderabad. Hon’ble Minster for IT, Municipal Administration & Urban Development, Industries & Commerce, Public Enterprises, Shri. K.T.Rama Rao inaugurated this facility recently. DiabetOmics will utilize this facility to commercialize their highly accurate, easy-to-use, bluetooth-enabled and non-invasive diabetes point of care (POC) tests and maternal health tests in India and around the world. Ventureast invested about 4 million in DiabetOmics in 2015. This new facility, which is situated in a three acre plot in Muppireddipally will directly employ about 100-120 people. The overall capacity of the plant will be to produce 8-10 million test strips a year and 10,000 to 15,000 assembled readers to begin with. The company has completed construction of their world-class manufacturing plant and the technology transfer from USA. The commercial production is expected to begin in the next quarter this year and will target the Indian and European markets. The global burden of diabetics is over 375 million, with India (72 million) and China (109 million) as major epicenters for diabetes. Dr. Srinivasa Nagalla, CEO of DiabetOmics Inc., said “We are pleased to bring these innovative diagnostic tests to the market beginning later part of this year which will be a huge paradigm shift for the patients around the world particularly for emerging countries like India where the affordability of quality care is a major burden for many low income families”. In addition to saliva-based diabetes tests, the company is currently developing point-of-care tests for rapid screening of Type I diabetes and early detection of diabetic kidney and eye complications. Across the world, it has been identified that Preeclampsia is the second leading cause of maternal death and gestational diabetes which is a common prenatal complication affecting 16 percent pregnancies. Mr. Venkatadri Bobba, Director- DiabetOmics & General Partner, Ventureast said, “DiabetOmics has come a long way from the discovery of the Salivary Glycoproteins as the best biomarkers for Glycemic Index to product and Bluetooth-enabled readers. The new plant will be in full compliance with global regulatory requirements and will showcase high quality and low cost manufacturing capabilities of our highly qualified & well trained staff and the ecosystem enabled by the State of Telangana. Most importantly, it is gratifying to note that many patients and their families could benefit from our innovations beginning later part of this year.” Dr. Varaprasad Reddy, Founder Shantha Biotech and Chairman Diabetomics India said, “We are excited that our manufacturing facility has been built, technology transferred, within months of getting the CE Mark (European approvals) and start supplying the products to the needy patients in just about 2 years from the date of laying foundation stone in Feb 2016. We are happy to bring this innovative non-invasive testing which is free of pain and patient friendly to the market.” ]]> https://biospectrumindia.com/news/97/10502/medanta-collaborates-with-masimo.html https://biospectrumindia.com/news/97/10502/medanta-collaborates-with-masimo.html Wed, 28 Feb 2018 12:35:00 +0530 In association with US-based medical technology firm, Masimo Corporation, Medanta hospital has announced a first-of-its-kind critical patient monitoring and recovery technology (Radius-7) in South Asia. Radius-7 is a wearable, tether-less Pulse CO-Oximeter® that works in conjunction with a bedside monitor to provide continuous non-invasive monitoring, while allowing patients freedom of movement. On a constant, dynamic, real-time basis this wearable tool helps ensure patient stability, besides aiding faster recovery through minimum time in bed. The technology additionally allows supplemental remote monitoring and clinical notification system that enables monitoring patient data remotely, as well as relaying alarm notifications to clinicians, wherever they may be. The technology significantly reduces false alarms and increases true alarm detection, allowing clinicians to focus on the patients and alarms that need most attention. Announcing the adoption of Radius 7, Dr. Naresh Trehan, Chairman and Managing Director, Medanta said: ‘’Medanta abides by the best possible patient recovery ecosystem benchmarked to global standards. State-of-the-art technology is an essential aspect of this value. Adoption of Radius-7 illustrates our deep commitment to patient-centric clinical excellence.’’ Jon Coleman, President, Worldwide Sales, (Professional Services and Medical Affairs), Masimo Corporation, added “We are very proud to be associated with Medanta which is one of the most admired healthcare delivery brands internationally. Masimo’s technologies have had tremendous impact on patient care globally and we want to be part of India’s efforts to make healthcare safer, better and more accessible.” Studies have shown that patient mobility is a key factor in accelerating recovery. Radius-7 is lightweight and can be attached to the patient’s arm, allowing untethered monitoring for a patient in as well as out of bed. It reduces the need for physical nursing assistance since there is no need to disconnect from or re-connect to a bedside monitor. The device continuously and non-invasively monitors vital parameters. Data is then sent to a server which communicates with a central system stationed in the ward where clinicians/nurses can view the vital parameters of the patient. In the event of any breach of vital parameter thresholds, the assigned nurse receives a notification on the pager. There is an escalation protocol if the primary nurse does not respond within a stipulated time. This ensures that no events are missed.   ]]> https://biospectrumindia.com/news/97/10478/medtech-zone-signs-25-mous-worth-rs-5090-cr.html https://biospectrumindia.com/news/97/10478/medtech-zone-signs-25-mous-worth-rs-5090-cr.html Mon, 26 Feb 2018 13:20:00 +0530 At the recently held Medical Equipment session during the CII Partnership summit,  Andhra MedTech Zone (AMTZ) signed a total of 25 MoUs worth Rs 5,090 crore with an employment opportunity of 4,750 jobs pertaining to the health sector. AMTZ will soon have a 3D printing facility for fitting implants and affordable glucometers for every household and will also be the first hub in the country to manufacture CT scan machines within a year. According to AMTZ CEO Jitender Sharma, reduction of basic customs duty on medical devices that enables import of spare parts at a cheaper cost, non-requirement of FDI approval and encouraging market access policy of the government have given a boost to medical device manufacturers. At AMTZ, 18 high-end labs and 200 factories are coming up including a factory that would produce affordable glucometers.  ]]> https://biospectrumindia.com/news/97/10445/aeras-announces-potential-phase-ii-tb-vaccine-trial.html https://biospectrumindia.com/news/97/10445/aeras-announces-potential-phase-ii-tb-vaccine-trial.html Wed, 21 Feb 2018 13:00:00 +0530 A nonprofit organization dedicated to developing vaccines against tuberculosis (TB), Aeras has announced results from an innovative clinical trial that provides encouraging new evidence that TB vaccines could prevent sustained infections in high-risk adolescents.  In a prevention-of-infection phase 2 trial conducted in South Africa, revaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduced sustained TB infections in adolescents.  An experimental vaccine candidate, H4:IC31, also reduced sustained infections, although not at statistically significant levels. However, the trend observed for H4:IC31 is the first time a subunit vaccine has shown any indication of ability to protect against TB infection or disease in humans. The study evaluated H4:IC31 vaccination and BCG revaccination for safety, immunogenicity and the ability to prevent initial and sustained TB infections among healthy adolescents in the Western Cape Province of South Africa. H4:IC31 is an investigative subunit vaccine candidate being developed jointly by Aeras and Sanofi Pasteur, the vaccines business of Sanofi, and the Statens Serum Institut.  The clinical trial was conducted at SATVI and at the Emavundleni Research Centre (part of the Desmond Tutu HIV Centre). It was funded by Sanofi Pasteur, the United Kingdom’s Department for International Development, The Bill & Melinda Gates Foundation and Aeras. The study was approved by the Medicines Control Council of South Africa and the relevant local independent ethics committees. ]]> https://biospectrumindia.com/news/97/10415/transasia-wins-india-medical-devices-export-company-of-the-year.html https://biospectrumindia.com/news/97/10415/transasia-wins-india-medical-devices-export-company-of-the-year.html Thu, 15 Feb 2018 16:10:00 +0530 Transasia Bio-Medicals Ltd., India’s Leading In-vitro Diagnostic Company, has been conferred the ‘India Medical Devices Export Company of the Year’ award by the Ministry of Chemicals & Fertilizers, Government of India. Mr. Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals Ltd. received the award through the hands of Shri Ananth Kumar, Hon’ble Minister (Chemicals & Fertilizers), Government of India, at the 3rd International Exhibition & Conference on Pharmaceutical & Medical Devices Industry – India Pharma 2018 & India Medical Device 2018 held today at the Bangalore International Exhibition Centre, Bengaluru. Shri Suresh Prabhu, Union Minister of Commerce and Industry, Shri Jagat Prakash Nadda, Hon’ble Union Minister for Health & Family Welfare and other well known dignitaries graced the conference. On receiving the award, Mr. Vazirani remarked, “I am honored to receive this prestigious award and grateful to the Ministry of Chemicals & Fertilizers, Government of India for conferring it on us. I am proud that Transasia is contributing to the growth of the economy through its exports to over 110 countries. With a vision of creating a ‘Healthier and Happier World’, Transasia has been successfully combining world-class technologies from our global subsidiaries with efficient, low cost manufacturing in India to meet the diagnostic needs of India and the other emerging markets.” He further added, “On this note, I would like to thank the Government of India for recognizing medtech as a sunrise sector in its Make in India initiative. India’s products are being recognized worldwide for their quality, reliability and affordability. The recent reforms are giving an impetus to the growth of this sector. Further boosts are welcome.” The award for the ‘India Medical Devices Export Company of the year’ category along with other categories was instituted by the Govt. of India in order to encourage indigenous manufacturing of medical devices.   To this effect, Transasia is the first Indian In-vitro Diagnostic Company to manufacture and export state-of-the-art blood analyzers and reagents, way back in 1990s. Transasia's main focus remains on the emerging countries in Asia, Africa, the Middle East, Latin America and Eastern Europe. In Asia, besides India it caters to the diagnostic needs of countries such as Thailand, Indonesia, Philippines and Vietnam. With over 14 overseas acquisitions in countries as varied as the Czech Republic, Germany, U.K, France, Italy, Russia, Turkey, and the US, Transasia serves millions. The exhibition brought together key decision makers from the realms of the industry, academia, regulators and government to gauge opportunities and estimate the potential of indigenous manufacturing for medical devices in India and thereby create an ecosystem to enable path breaking initiatives and innovations. ]]> https://biospectrumindia.com/news/97/10389/pluss-collaborates-with-drger-for-promoting-its-innovative-device.html https://biospectrumindia.com/news/97/10389/pluss-collaborates-with-drger-for-promoting-its-innovative-device.html Tue, 13 Feb 2018 11:25:00 +0530 Gurugram based Pluss Advanced Technologies, winner of the National Technology Day Innovation Award for its patent pending device MiraCradle to treat Birth Asphyxia, has collaborated with Dräger, a Germany based global leader in the fields of medical and safety technology. The World Health Organization (WHO) estimates that over 650,000 babies worldwide die from birth asphyxia each year. Those who survive the condition often suffer serious and irreparable damage that can result in lifelong physical and mental disabilities. Developed in collaboration with CMC Vellore, MiraCradle - Neonate Cooler is the world's first affordable, non- electronic, portable device based on savE Phase Change Materials (PCMs) which helps in cooling the baby and maintains the core body temperature precisely between 33-34 degrees for a period of 72 hours. Pluss and Dräger are joining hands to leverage upon each other's strengths and to help bring this technology to as many lower and middle income group countries as possible. The immediate focus is to be able to make this available in the countries of Asia and Africa and later also South America. ]]> https://biospectrumindia.com/news/97/10287/trivitron-healthcare-ventures-out-for-services-in-africa.html https://biospectrumindia.com/news/97/10287/trivitron-healthcare-ventures-out-for-services-in-africa.html Wed, 31 Jan 2018 10:00:00 +0530 Leading medical device company Trivitron Healthcare has announced a joint venture with Investment Funds for Health in Africa (IFHA) to provide medical devices and instruments in the continent. The joint venture firm Trivitron Healthcare Africa BV will provide medical devices and instruments with reliable after-sales service support across the continent, thereby improving access and affordability of medical equipment. Apart from distributing and supporting products manufactured by Trivitron in its USFDA (US Food and Drug Administration), CE certified factories in India, Finland and Turkey, the JV firm will also distribute and support products from other multinational corporations. In the first phase, the joint venture firm will be headquartered in Dubai with a direct presence and sales and service infrastructure in four major hubs -- Nairobi, Johannesburg, Lagos and Algiers. The initial offering by the firm will include a complete range of products and after-sales service support in laboratory medicine, medical imaging, critical care, operating room and renal care. ]]> https://biospectrumindia.com/news/97/10273/safeheal-starts-ce-mark-clinical-study-to-replace-ostomy.html https://biospectrumindia.com/news/97/10273/safeheal-starts-ce-mark-clinical-study-to-replace-ostomy.html Mon, 29 Jan 2018 17:40:00 +0530 SafeHeal, a leading innovator in the field of digestive surgery and developer of the Colovac device, announces that it has enrolled the first five patients in its CE mark study. The Colovac device is a unique endoluminal bypass sheath placed in the colon following rectal resection, aimed at significantly improving the recovery of patients after colorectal surgery without the need for an ostomy.  This prospective, single-arm, 15-patient study, was approved at the end of 2017 by the French health authority ANSM. It aims to evaluate the safety and efficacy of Colovac for the protection of colorectal anastomosis in adult patients initially scheduled to receive a diverting ostomy as per standard of care, following colorectal surgery. In the study, patients receive a Colovac device in lieu of the ostomy. The study is currently enrolling more patients at two hospitals in France (Strasbourg and Paris). Based on this early experience, the trial confirms the good usability of the device, its placement and retrieval, in line with preclinical experiments. Colovac was well tolerated by patients.  ]]> https://biospectrumindia.com/news/97/10249/philips-india-launches-innovative-imaging-solutions.html https://biospectrumindia.com/news/97/10249/philips-india-launches-innovative-imaging-solutions.html Wed, 24 Jan 2018 14:40:00 +0530 Philips India Ltd, a leading health technology company, announces the launch of its new range of next generation imaging solutions namely Access CT 32 Slice, Ingenia Prodiva 1.5T MRI and Dura Diagnost F30 Digital X-ray. With an aim to provide reliable imaging solutions, these customised products are supported by artificial intelligence (AI)-driven software and help better diagnosis and improved patient experience. Through these advanced technological innovations, Philips reiterates its commitment to providing best value healthcare products which are accessible and ensures accurate diagnosis and enhanced patient experience. Empowered with a user-friendly interface, Philips’ imaging solutions are also easy to operate and take lesser preparation time for patients, these solutions provide high image quality, streamline workflow and reduce variability thus providing better diagnostic outcomes for radiologists. Built on Philips’ advanced technologies, all these Imaging System solutions have their own unique features. Access CT offers flexibility, exceptional image quality, and diagnostic accuracy with lower total cost of ownership. Ingenia Prodiva MR is built on proven dStream digital broadband technology, present in over 2000 installations worldwide which can accelerate patient throughput with a simplified Breeze Workflow. It has an intuitive user interface enhanced by guided and standardized examination procedures helps perform routine MRI exams from day one. DuraDiagnost F30 Digital X-ray provides ease-of entry into the world of digital radiography with a price to performance ratio that’s hard to beat; it helps simplify the path to clinical decision-making, improves outcomes for patients, and reduces the imaging department burden. Rohit Sathe, President Philips Healthcare, India said “Philips has always been focussing on the emerging workflow and diagnostic needs of radiologists in India, by developing meaningful innovations in imaging.The new offerings in MRI, CT and Digital X-ray are developed to help radiologists diagnose faster, more accurately with added benefit of lower ownership costs and better patient experience. I am sure that these solutions will effectively meet the expectations of the radiologists and imaging departments". As healthcare organizations continue to move toward value-based care, there is a growing need for intelligent solutions to help address the biggest challenges radiologists face in improving outcomes, simplifying data and insights gathering, lowering the cost of healthcare delivery, and enhancing patient and staff satisfaction.  The range of Philips Imaging System solutions will be showcased at Asian Oceanian Congress of Radiology and Annual Conference of the Indian Radiology and Imaging Association (IRIA) to be held from 25th-28th January, 2018 in Mumbai. ]]> https://biospectrumindia.com/news/97/10246/applied-dna-to-establish-unit-in-india.html https://biospectrumindia.com/news/97/10246/applied-dna-to-establish-unit-in-india.html Wed, 24 Jan 2018 11:15:00 +0530 US based Applied DNA Sciences, Inc. has announced the establishment of a Central DNA Testing Laboratory in Ahmedabad, India providing full forensic authentication services. Officially opening on February 15, 2018, the Central Laboratory is strategically located in the state of Gujarat, an economic hub for the development and advancement of cotton, other textiles, fertilizers, petrochemicals and pharmaceuticals. Dr. Ila Lansky, a forensic scientist with over 11 years of forensic DNA experience, will direct the Central DNA Testing Laboratory. She currently oversees all aspects of forensic analysis, testing, authentication and reporting for all samples submitted, following the standard operating procedures established by Applied DNA’s New York forensic laboratories. Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics and therapeutics. The Company makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. ]]> https://biospectrumindia.com/news/97/10236/kiht-to-launch-medical-technology-e-auction.html https://biospectrumindia.com/news/97/10236/kiht-to-launch-medical-technology-e-auction.html Tue, 23 Jan 2018 15:15:00 +0530 India’s flagship institute dedicated to medical devices, Kalam Institute of Health Technology (KIHT) is all set to launch its ambitious e-auction programme.  Set up under the Andhra Pradesh MedTech Zone (AMTZ) project initiative, KIHT aims at providing critical component knowledge to relevant institutions for focused research and development. According to KIHT, several prototypes, developed by researchers at IITs, universities and engineering colleges, are lying in these institutions. Unless they reach the prospective manufacturers, huge amounts invested for their research and development will not benefit the indigenous industry and the public at large. The e-auction programme will help resolve this issue. The institute has a separate cell for facilitating technology transfer and scientific cooperation. It intends to connect with knowledge networks such as national and international organisations, industry associations, business councils, regulatory agencies and trade departments.KIHT is headed by a governing board comprising Association of Indian Medical Device Industry (AiMED), Stanford-India Biodesign (SIB) Programme, Biotechnology Industry Research Assistance Council (BIRAC) and other member institutions.  Indian medical device manufacturers have been pushing for constructive measures to promote the domestic industry and reduce import dependency which would get reflected in healthcare cost.  ]]> https://biospectrumindia.com/news/97/10227/grunenthals-surgical-sealant-receives-ce-certification-.html https://biospectrumindia.com/news/97/10227/grunenthals-surgical-sealant-receives-ce-certification-.html Fri, 19 Jan 2018 17:30:00 +0530 The Grunenthal Group is science-based pharmaceutical company specialized in pain, gout and inflammation. Grunenthal announced that Adhesys Medical GmbH, a wholly-owned subsidiary of the Grunenthal Group, has received CE-Certification for MAR-CUTIS (Flix®). Flix® is a topical skin adhesive for surgical use and the first product from Grunenthal's innovative pipeline of surgical sealants.  Grunenthal acquired Adhesys Medical GmbH and its US affiliate, a medical device start-up, in April 2017 and holds the worldwide development and commercialization rights for an innovative pipeline of surgical sealants and the underlying technology platform. The polyurethane-based technology is unique, as it comes with an unmet combination of features such as bonding strength, fast sealing and flexibility. The products based on this technology may therefore serve a wide variety of surgical procedures, including sealing in wet environments and allow Grunenthal to tap into the global surgical sealants market. With devices and technologies like surgical sealants, the company broadens their portfolio beyond the development of new chemical entities (NCEs) in focus areas of high unmet medical need that is pain and inflammation. ]]> https://biospectrumindia.com/news/97/10221/11th-annual-iscr-conference-collaborative-clinical-research-for-better-patient-outcomes-.html https://biospectrumindia.com/news/97/10221/11th-annual-iscr-conference-collaborative-clinical-research-for-better-patient-outcomes-.html Thu, 18 Jan 2018 20:25:00 +0530 Collaborative Clinical Research for Better Patient Outcomes is the theme of the 11th Annual Conference of the Indian Society for Clinical Research (ISCR) being held in Bangalore on the 19th and 20th of January, 2018. The two-day event, preceded by pre-conference workshops, will see over 800 clinical research professionals from across India and other countries deliberate on the collaborative role of clinical research stakeholders in a strengthened and improved clinical research regulatory environment. “The challenges of the last few years set back the progress of clinical research in India which has impacted patients the most as it has delayed their access to newer and more advanced treatment,” said Dr. Chirag Trivedi, President, ISCR. “With more balanced and rational regulations in place, it is important for all stakeholders of clinical research to now discuss and evolve strategies to grow the clinical research environment in the country, while ensuring patient safety as well as high quality clinical research for better patient outcomes.” With the second highest population in the world and a large disease burden (at 20%), less than 1.4% of global clinical research happens in India. “We need to make newer and better treatment options available locally and to patients globally. For this, India must proactively participate in conducting clinical research (“Research in and for India”) and assume a leadership role globally so that we can offer newer treatment options for our patients in India and across the world (“Made for the World”),” added Dr. Trivedi.  “The 11th Annual Conference is being held at a very critical time for the Indian clinical research industry,” said Dr. Ramesh Jagannathan, Chair, Organising Committee, 11th ISCR Conference. “We have a significant task ahead of us in terms of not just strengthening the overall infrastructure for and governance of clinical research in the country, but also in empowering patients who are at the core of any clinical research activity. Patients First is an important ethos of ISCR and our 11th Annual Conference is also a renewal of our pledge to quality, patient safety and data integrity.” Preceding the Conference are two days of workshops on various aspects of clinical research including evidence based medicine, pharmacovigilance, risk-based monitoring, clinical pharmacology and careers in clinical research. The 2017 “India: Health of the Nation's States — The India State-Level Disease Burden Initiative”  report states that  the contribution of most major non-communicable disease categories to the total disease burden has increased in all Indian states since 1990. These include cardiovascular diseases, diabetes, chronic respiratory diseases, mental health and neurological disorders, musculoskeletal disorders, cancers, and chronic kidney disease. Diarrhoeal diseases, lower respiratory infections, iron-deficiency anaemia, neonatal disorders, and tuberculosis continue to be major public health problems in many poorer states of North India. “Clinical research is essential not only for developing medicines for emerging health concerns (such as antibiotic resistant pathogens, H1N1, Ebola virus, etc.)  but also for entrenched, tropical diseases (such as diseases such as malaria, leishmaniasis, etc.) and lifestyle diseases such as diabetes and hypertension. Given our large unmet health needs and limited resources, we need to make newer and better treatment options available to our population in a quick, economical and dependable manner,” said Dr. Denis Xavier, Chair Scientific Committee, 11th National Conference and Vice Dean, St John’s Medical College. With the overarching theme of “Collaborative Clinical Research for better Patient Outcomes”, the topics for the Conference have been deliberately chosen to be of relevance to sponsor, academia and investigator-initiated research and cover various aspects of clinical research conduct involving multiple stakeholders. Given India’s potential to emerge as a big player in data-driven clinical research services, two Conference tracks have been planned focusing on Clinical Operations as well as Clinical Data Management/ Biostatistics/ Medical Writing. “The great advances in medicine that have occurred over the last 60 years have largely been the result of clinical research,” said Dr. Prem Pais, Former Dean, St John’s Medical College and an Investigator in several studies. “Clinical research has not only identified new and effective treatments but has also identified harmful treatments that has saved many lives. As an example, 60 years ago 30 per cent of people who suffered a heart attack died in the first month. Today about 8 per cent do.” Dr. Pais spoke of the need to create more awareness about clinical research so that patients are aware of their rights and the value that clinical trials can offer. Dr. Trivedi said that it was imperative that the new and improved regulatory environment in India was communicated to the world at large so that more clinical research is conducted in India. A conducive clinical research ecosystem will encourage more research and development and will give an impetus to the Government of India’s ‘Make in India’ initiative. “As compared to 2016, close to a two and a half to three-fold increase has been observed in the number of global clinical trials approved by the DCGI in 2017 which indicates that the recent regulatory changes have had a positive impact but we still need to do more,” he said. He spoke of two major challenges that need to be addressed – the proposed mandatory accreditation of Ethics Committees which if implemented from January 2018 could cause huge operational challenges since majority of the Ethics Committees have not yet applied form accreditation and the need to continue advocacy efforts to create more awareness amongst various important stakeholders about the good that clinical research has done for our Indian patients in fighting their unmet medical needs. “We are as committed to the DCGI’s commitment to making safe, efficacious, affordable and quality medicinal products for our people,” concluded Dr. Trivedi. ]]> https://biospectrumindia.com/news/97/10201/check-cap-gets-ce-mark-approval-for-c-scan.html https://biospectrumindia.com/news/97/10201/check-cap-gets-ce-mark-approval-for-c-scan.html Tue, 16 Jan 2018 12:30:00 +0530 Check-Cap is a clinical-stage medical diagnostics company developing C-Scan, the first capsule-based system for preparation-free colorectal cancer screening. The company declared it has received CE Mark approval for the C-Scan system. The C-Scan system offers an alternative to current colon cancer screening methods that require laxative preparation and invasive endoscopic procedures. This novel platform consists of a fully autonomous system that utilizes an ingestible, ultra-low dose X-ray capsule combined with a state of the art wireless tracking system, enabling generation of structural information on the lumen of the colon. This information is used to create 2D and 3D maps of the colon, allowing physicians to identify pre-cancerous polyps and other abnormalities. C-Scan is designed to improve the patient experience and increase the number of adults screened by eliminating procedural requirements frequently cited as barriers to adherence to screening guidelines such as bowel preparation, fasting, and sedation. ]]> https://biospectrumindia.com/news/97/10190/local-makers-of-medical-devices-seek-increase-in-custom-duty.html https://biospectrumindia.com/news/97/10190/local-makers-of-medical-devices-seek-increase-in-custom-duty.html Fri, 12 Jan 2018 17:45:00 +0530 According to Association of Indian Medical Device Industry (AiMeD), the government needs to increase the basic customs duty on medical devices in the range of 5-15 per cent to promote domestic manufacturing. The current slab is 0-7.5 per cent, according to AiMeD Forum Coordinator Rajiv Nath, It should be 20 per cent to maintain the investment climate where import dependency is 90 per cent.  The industry body urged the government to introspect as to why, even after three years of the 'Make in India' campaign, the medical device manufacturing is still struggling.  On its expectations from the Union Budget (2018-19), AiMeD said the medical devices sector expects, "extension of inverted duty tariff rationalisation to medical electronics & diagnostics". It also urged the government to expedite buy Indian policy drafted by Department of Pharmaceuticals which is pending with Ministry of Health & Family Welfare. AiMeD also asked the Department of Pharmaceuticals to accelerate trade margin capping proposal in the range of 50- 100 per cent, depending on the cost of the devices. ]]> https://biospectrumindia.com/news/97/10178/fda-has-granted-investigational-device-exemption-approval-ide-to-bioprotect-.html https://biospectrumindia.com/news/97/10178/fda-has-granted-investigational-device-exemption-approval-ide-to-bioprotect-.html Wed, 10 Jan 2018 17:20:00 +0530 BioProtect, the technology leader in biodegradable balloon spacers protecting normal tissue during radiation therapy, announced the launch of its clinical trial following Investigational Device Exemption (IDE) approval granted by the FDA in November 2017.   The trial is a prospective, randomized study to demonstrate the safety and efficacy of the ProSpace biodegradable spacer to protect the rectum and lower GI tract during radiation therapy for prostate cancer compared to patients without any spacers. ProSpace is approved for sale in Europe under CE regulations. The company believes it could be used to spare the rectum in hundreds of thousands of patients who are undergoing prostate cancer radiotherapy every year. The potential global market for the ProSpace is estimated to exceed $1.2 Billion annually. ]]> https://biospectrumindia.com/news/97/10176/iscr-conference-2018-collaborative-clinical-research-for-better-patient-outcomes.html https://biospectrumindia.com/news/97/10176/iscr-conference-2018-collaborative-clinical-research-for-better-patient-outcomes.html Wed, 10 Jan 2018 15:05:00 +0530 Collaborative Clinical Research for Better Patient Outcomes will be the theme of the 11th Annual Conference of the Indian Society for Clinical Research (ISCR) which will be held at JW Marriott, Bangalore, from January 19th to 20th. The two-day event is focused on bringing together different stakeholders across the clinical research continuum on a common platform to deliberate on the future that the clinical research fraternity in India needs to take in an improved regulatory environment.   Stakeholders will meet and deliberate on opportunities to learn, partner and collaborate while strengthening the ethical conduct of clinical research and creating better outcomes for patients. Around 400-500 clinical research professionals are expected to attend the event. Leading up to the annual conference, five pre-conference workshops have been scheduled for the clinical researcher fraternity and medical and pharma students on January 17th and 18th. These workshops will focus on principles of evidence based medicine and its applicability in India, career opportunities in clinical research and associated fields, pharmacovigilance (PV) audits and inspections, role of clinical pharmacology in drug discovery and development and risk based monitoring in clinical trials. ]]> https://biospectrumindia.com/news/97/10174/fluke-biomedical-launched-vt650-and-vt900-gas-flow-analyzers.html https://biospectrumindia.com/news/97/10174/fluke-biomedical-launched-vt650-and-vt900-gas-flow-analyzers.html Wed, 10 Jan 2018 12:50:00 +0530 Fluke Biomedical introduces the VT650 and VT900 Gas Flow Analyzers, which include one-channel, full-range air flow functionality that streamlines testing.  The VT650 and VT900 offer the highest accuracy and reliability on the market for gas flow and respiratory medical equipment testing, including all types of ventilators, flow meters, pressure gauges, and anesthesia and other machines.  The VT650 features a full-range ±300 liter-per-minute (lpm) airflow channel with built-in oxygen, temperature, and humidity measurements. Designed and tested to world-renowned Molbloc-L calibration specifications, it ensures traceability to global regulatory standards and is great for basic needs ventilator and gas-flow testing.  The VT900 has all the ease-of-use and features of the VT650, plus an external TTL trigger input and special ultra-low flow and ultra-low-pressure ports for high accuracy in critical low volume and pressure testing such as for anesthesia machines and flow meters.  The analyzers' large onboard memory allows storage of customized test profiles and testing of multiple medical devices back-to-back without having to transfer data between tests. This data is simply recorded and stored, which saves time. When testing is completed, saved data can be transferred via the USB port to a PC and test results uploaded to CMMS systems for easy documenting and reporting. ]]> https://biospectrumindia.com/news/97/10170/fda-accepted-nevros-senza-ii-for-chronic-pain-treatment-.html https://biospectrumindia.com/news/97/10170/fda-accepted-nevros-senza-ii-for-chronic-pain-treatment-.html Tue, 09 Jan 2018 18:10:00 +0530 Nevro Corp., a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain. The company announced that it has received FDA approval for its next-generation Senza II Spinal Cord Stimulation (SCS) System delivering HF10 therapy. Nevro’s Senza High-Frequency Spinal Cord Stimulation System delivers similar electrical pulses but at a higher rate than currently available devices. Data from previous European clinical studies suggest that Nevro’s proprietary high-frequency waveform may be effective in treating low back pain and other challenging types of chronic pain that often do not respond to conventional spinal cord stimulation. Data also show that Nevro’s technology can deliver pain relief without paresthesia and relive from unpleasant side effects. The Senza II system offers the superior outcomes and clinical advantages of HF10 therapy through a smaller and more refined footprint while maintaining the performance and durability of the current Implantable Pulse Generator (IPG). Superior, Non-Opioid Therapy Now Delivered in a Smaller and More Refined IPG. ]]> https://biospectrumindia.com/news/97/10155/cerebrotech-visor-receives-fda-nod.html https://biospectrumindia.com/news/97/10155/cerebrotech-visor-receives-fda-nod.html Fri, 05 Jan 2018 12:40:00 +0530 Clearance of a simple, easy-to-use device that can provide accurate information about cerebral fluids in 30 seconds is an important development  Cerebrotech Medical Systems is a venture capital-backed company dedicated to designing neurotechnology solutions to improve the care of brain-injured patients worldwide.      For the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor the company has received clearance from the Food and Drug Administration, The clearance includes a broad indication for use as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The company is continuing its clinical studies to further validate the device for identifying specific brain pathologies including stroke, trauma, swelling and others.  The Visor is a noninvasive bioimpedance spectroscopy device that detects changes and distribution of cerebral fluids using its proprietary technology called Volumetric Impedance Phase-shift Spectroscopy (VIPS™). Many neurologic conditions create a difference in fluid volumes between the brain's right and left hemispheres. The device detects that fluid asymmetry as a change in the ratio of bioimpedance measurements on each of the two sides. The company has developed a proprietary machine learning system to optimize its algorithms to recognize ]]> https://biospectrumindia.com/news/97/10144/hycor-biomedical-applies-ce-mark-for-noveos.html https://biospectrumindia.com/news/97/10144/hycor-biomedical-applies-ce-mark-for-noveos.html Thu, 04 Jan 2018 13:05:00 +0530 Hycor Biomedical, a leading manufacturer of in vitro diagnostic products for allergy and autoimmune testing. The company announced that it has applied the CE mark to its allergy testing system, NOVEOS™ along with an initial menu of Total IgE and over one hundred Specific IgE allergen reagents. In NOVEOS only 4µL of patient sample volume is required which can be especially important in pediatric and geriatric sampling.  It had great capacity for up to 8 hours of continuous testing. This eliminates the need to continuously replenish materials throughout a typical work day.  It allows maximum walk away time for laboratory technicians by allowing up to 75 tests per specific allergen and up to 140 allergens on the system at any time.  As the allergen industry moves to more highly enriched or standardized extracts, the NOVEOS system has incorporated these materials to provide more consistent and accurate results.  Hycor will be seeking 510(k) clearance from the Food and Drug Administration in the United States in the future. ]]> https://biospectrumindia.com/news/97/10121/thyrocare-launches-affordable-tb-diagnostic-facility.html https://biospectrumindia.com/news/97/10121/thyrocare-launches-affordable-tb-diagnostic-facility.html Mon, 01 Jan 2018 11:00:00 +0530 Mumbai based diagnostics services provider Thyrocare has recently launched FocusTB, its affordable brand focusing on tuberculosis (TB) diagnostics. Access to sophisticated diagnostics and high quality treatment comes as a costly affair for most TB patients. This leads to inconsistencies in proper follow-up of this disease, in turn leading to uneven patient care and under-diagnosis. Focus TB is a brand focused on affordable and quality TB diagnostics powered by Thyrocare Technologies Limited, which is India’s first and most advanced totally automated laboratory having its strong presence in more than 2000 cities/towns in India and internationally. Many laboratories and hospital brands in India, Middle East and South East Asian countries, use Thyrocare to complete their menu and deliver quality at an affordable cost. FocusTB services are available throughout India through Thyrocare’s Pan Asian network with more than 30,000 sample collection points. Drug resistant strains of TB pose a significant public health hazard and must be addressed by India’s healthcare sector sooner than later. Thyrocare is bringing highly advanced technologies like PCR to bear against this adversary for the first time in India. ]]> https://biospectrumindia.com/news/97/10084/indian-market-hooked-by-local-stent-companies.html https://biospectrumindia.com/news/97/10084/indian-market-hooked-by-local-stent-companies.html Thu, 21 Dec 2017 16:40:00 +0530 As multinational stent makers ponder their prospects in India after price controls introduced this year, their local rivals, which had been struggling to make a mark, have popped up on the radar of private equity investors. Leading domestic stent manufacturers Sahajanand Medical Technologies (SMT) and Translumina Therapeutics are among those in the fray to rise funding.  "We have been approached by quite a few PE players and have got a lot of interest from global investors after the price control," said Ganesh P Sabat, chief executive officer of SMT, based in Surat, declining to disclose more details. The company rose close to Rs 170 crore from Samara Capital last year and is looking for additional funding. New Delhi-based Translumina Therapeutics plans to double production capacity by March and acquire new technology overseas. "We are in preliminary talks with several funds to raise money. Our plan is to start manufacturing in Iran, Russia, Saudi Arabia and a few other countries where there are local incentives available," said Gurmit Singh Chugh, managing director of Translumina.  Domestic stent makers have strong relation with hospitals and doing well with the sales specifically in smaller town. This is the reason why PE player are interested for funding and investing in local stent market. The National Pharmaceutical Pricing Authority reduced prices of cardiac stents by over 75% in February. This lower down of pricing made global manufacturers like Abbott Boston disappointed. The regulator also concealed distributor margins, which analysts said almost levelled the prices of domestic and MNC stents. The pricing regulation put the viability of distributor business models under significant pressure. This stress has been relatively less for distributors of domestic manufacturers as volume growth and an expanded portfolio have partially offset margin losses on account of price curbs. ]]> https://biospectrumindia.com/news/97/10085/indian-market-hooked-by-local-stent-companies.html https://biospectrumindia.com/news/97/10085/indian-market-hooked-by-local-stent-companies.html Thu, 21 Dec 2017 16:40:00 +0530 As multinational stent makers ponder their prospects in India after price controls introduced this year, their local rivals, which had been struggling to make a mark, have popped up on the radar of private equity investors. Leading domestic stent manufacturers Sahajanand Medical Technologies (SMT) and Translumina Therapeutics are among those in the fray to rise funding.  "We have been approached by quite a few PE players and have got a lot of interest from global investors after the price control," said Ganesh P Sabat, chief executive officer of SMT, based in Surat, declining to disclose more details. The company rose close to Rs 170 crore from Samara Capital last year and is looking for additional funding. New Delhi-based Translumina Therapeutics plans to double production capacity by March and acquire new technology overseas. "We are in preliminary talks with several funds to raise money. Our plan is to start manufacturing in Iran, Russia, Saudi Arabia and a few other countries where there are local incentives available," said Gurmit Singh Chugh, managing director of Translumina.  Domestic stent makers have strong relation with hospitals and doing well with the sales specifically in smaller town. This is the reason why PE player are interested for funding and investing in local stent market. The National Pharmaceutical Pricing Authority reduced prices of cardiac stents by over 75% in February. This lower down of pricing made global manufacturers like Abbott Boston disappointed. The regulator also concealed distributor margins, which analysts said almost levelled the prices of domestic and MNC stents. The pricing regulation put the viability of distributor business models under significant pressure. This stress has been relatively less for distributors of domestic manufacturers as volume growth and an expanded portfolio have partially offset margin losses on account of price curbs. ]]> https://biospectrumindia.com/news/97/10071/cytecare-launches-tele-consultation-program-in-bangladesh.html https://biospectrumindia.com/news/97/10071/cytecare-launches-tele-consultation-program-in-bangladesh.html Wed, 20 Dec 2017 12:45:00 +0530 Cytecare Hospital has recently launched its Tele-Consultation program in Bangladesh. With the goal of transforming the tertiary and quaternary healthcare system to be more accessible and affordable, Cytecare along with Expert Chikitsa is taking its fight against cancer to Bangladesh. As per WHO guidelines, Bangladesh should have 160 treatment centers in order to cater to its population. However, it has only 16. In addition to the launch of the Tele-Consultation program, Dr. Vikram Kekatpure and Dr. Anthony Pais, of Cytecare Cancer Hospital also engaged in various medical education initiatives, such as organizing a seminar on 'Functional Rehabilitation following Oral resection' at City Dental College, Dhaka; a Continuing Medical Education (CME) program on 'Changing paradigm of head and neck cancer management' which was attended by over 40 doctors; doctor and hospital visits with the intention of building a stronger doctor referral network; and a corporate health talk on 'Tobacco and Health Effects'. Suresh Ramu, CEO, Cytecare Cancer Hospitals, stated that there is a tremendous need for cancer awareness and supporting patients in Bangladesh with the right diagnosis and treatment advice. The dedicated information centers will offer video consultation for the patients and allow them to interact with top specialists of Cytecare Cancer Hospitals. It is important to make cancer treatment affordable and accessible for the common man. ]]> https://biospectrumindia.com/news/97/10070/prescient-surgical-got-fda-510k-clearance-for-its-novel-cleancision-system.html https://biospectrumindia.com/news/97/10070/prescient-surgical-got-fda-510k-clearance-for-its-novel-cleancision-system.html Wed, 20 Dec 2017 12:00:00 +0530 Prescient Surgical, Inc. located in San Carlos, Calif. is a medical device innovator that makes advanced tools and technologies to fight and defend against the sources of surgical site infection. The company announced that the U.S. Food and Drug Administration (FDA) have cleared the CleanCision Wound Retraction and Protection System (CleanCision System) for commercialization in the United States.  Developed by surgeons and infection control experts, CleanCision is the first in a new class of advanced technology. It is designed to fight and defend against the most pervasive sources of surgical infection. Utilizing active cleansing technology, CleanCision combines wound protection and irrigation in simple and effective retraction system that actively, consistently, and continuously clears harmful bacteria that may invade the incision during surgery.  When the threat of wound contamination is at its highest, CleanCision has been shown to reverse and reduce these pervasive sources of infection, clearing harmful bacteria throughout surgery. CleanCision can put more control over the root causes of infection into the hands of surgical teams where traditional methods fail to do so. Easily deployed to retract and protect the wound site, CleanCision provides access to the surgical site and uses a sterile irrigant solution, selected by the surgeon, to clear contamination invading the surgical incision. The wound edge is continuously and consistently irrigated while suction removes contaminants throughout the surgery. CleanCision is cleared for use in abdominal surgery and may aid in the prevention of wound edge contamination.  Hospitals can acquire CleanCision through the company's Early Access Program, developed to help surgical teams implement and measure the impact of the device as part of their infection reduction programs. ]]> https://biospectrumindia.com/news/97/10056/siemens-healthineers-to-acquire-fast-track-diagnostics.html https://biospectrumindia.com/news/97/10056/siemens-healthineers-to-acquire-fast-track-diagnostics.html Tue, 19 Dec 2017 11:50:00 +0530 German firm Siemens Healthineers has entered an agreement to acquire Luxembourg-based molecular diagnostic tests supplier Fast Track Diagnostics (FTD). Siemens intends to bolster its precision medicine portfolio, improve patient outcomes and decrease the time spent in the lab for identifying infections. With a total of 48,000 employees, Siemens Healthineers develops products and services for diagnosis, therapeutic imaging, and molecular medicine. The acquisition includes FTD sites in Luxembourg, Malta, and India, along with around 80 employees. After the transaction is completed, the firm is set to continue operating as Fast Track Diagnostics. FTD’s test can detect more than 140 viruses, bacteria, parasites and fungi that cause various infections such as respiratory, gastroenteritis, meningitis, hepatitis, immunosuppressed infections, tropical diseases, sexually transmitted disorders, and early childhood conditions. ]]> https://biospectrumindia.com/news/97/9993/fda-approves-paris-innovative-eflow-technology-to-treat-copd.html https://biospectrumindia.com/news/97/9993/fda-approves-paris-innovative-eflow-technology-to-treat-copd.html Thu, 07 Dec 2017 18:05:00 +0530 PARI Pharma announces the approval of its first innovative eFlow closed system nebulizer Magnair together with Sunovion's Lonhala (glycopyrrolate) Inhalation Solution. MAGNAIR, designed, optimized, and developed by PARI Pharma, is intended only for use with LONHALA (glycopyrrolate) Inhalation Solution vials in patients with COPD. The drug/device combination product received FDA approval on December 5th, 2017 under a New Drug Application (NDA). MAGNAIR is the first product to be commercialized using PARI Pharma's innovative eFlow closed system nebulizer technology which does not have a traditional open medication reservoir in which patients manually transfer the liquid drug product from a vial. MAGNAIR features a proprietary blow-fill-seal ampule which is inserted into the cap of MAGNAIR and pierced open once the cap of the MAGNAIR handset is closed, without the need for a manual filling step. This feature is designed to reduce risk of spilling of the medication when the vial is emptied. As with all eFlow Technology nebulizers, MAGNAIR allows the patient to breathe naturally without any special breathing technique. The patient inhales and exhales as they normally do at rest.  "With the approval of LONHALA MAGNAIR for COPD, we are bringing a new advancement in nebulizers that are designed to be efficient, silent and fast to people with COPD. It is great to see our technology addressing an unmet medical need for a nebulized LAMA," states Dr. Martin Knoch, President of PARI Pharma. "MAGNAIR is a great example of the flexibility of development and optimization using the eFlow Technology platform," added Geoff Hunziker, President of PARI Pharma's US sister company eFlow LLC.  "Sunovion is pleased that the FDA has approved LONHALA MAGNAIR as the first nebulized long-acting muscarinic antagonist treatment option for people in the U.S. living with COPD," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion. According to him, LONHALA MAGNAIR is an important advancement for patients who may prefer nebulized medications and a therapy that fits into their everyday lives. LONHALA MAGNAIR is approved for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ]]> https://biospectrumindia.com/news/97/9979/healthscape-summit-india-completes-its-5th-edition.html https://biospectrumindia.com/news/97/9979/healthscape-summit-india-completes-its-5th-edition.html Wed, 06 Dec 2017 14:15:00 +0530 As part of the Healthscape Series, the 5th Edition of Healthscape Summit India 2017 was held on 30th Nov- 1st Dec, 2017, at the Lalit Ashok, Bengaluru. Healthscape Summit – India, is an initiative by IDE Consulting Services, a global real estate solutions company. The summit offers one of a kind solution-oriented platform to overcome the challenges faced by the healthcare industry. Healthscape Summit facilitates Face-to-Face meetings, strategically modelled networking activities and information exchange amongst the most elite assemblage of Hospital Owners, Healthcare Architects, Design Consultants, industry experts and service providers making it the most sought after business summit by the healthcare fraternity of India. Owing to a collective effort in bridging the care disparity between rural and urban medical services, healthcare today has become one of India's largest revenue and employment generation sector. Ganesh Babu, Director of IDE, said “it is encouraging to witness an increase in government expenditure and the immediate future for the medical device industry is promising. India has increasingly become a leading destination for tertiary and quaternary care services with tremendous capital investments for advanced diagnostic facilities that caters to a large portion of inbound medical travellers from across the globe”. “Every single buyer and supplier attending the Healthscape Summit is pre-qualified to ensure that the meetings are productive. Buyers are qualified based on their upcoming or on-going projects and suppliers are qualified based on their ability and track record of catering to the Indian healthcare market”, he explained. The session opened on 30th November with the inaugural talk by Dr. Nandakumar Jairam, CEO, Chairman & GMD, Columbia Asia hospitals. He pointed out that the healthcare industry should be putting its focus on the patient as a person and adding more value to the services being offered. After the inaugural session, a panel discussion followed highlighting the technological advancements taking place in the healthcare field. The panel members included Dr. Vivek Desai, Founder Director, Hosmac; Dr. Sanjeev K Singh, Medical Superintendent, AIMS; Mr. Jagannath MS, CFO & Director, Columbia Asia; Dr. Pankaj Gupta, Operating Partner, 3737 North Capital LLP; Mr. Nandkishor Dhomne, VP-IT & CIO, Manipal Hospitals. The discussion focused on the importance, influence and challenges pertaining to technology in healthcare. It also centred upon the comprehensive process of identifying and implementing the optimal technology solution for meeting the desired end state. The moderator for the session, Dr. Vivek Desai mentioned, “the field of healthcare is changing big time now. The future is shaping up in front of our eyes mainly through digital technologies such as artificial intelligence, cognitive computing, 3D printing, robotics, nanotechnology etc”. On the second day, another panel discussion was conducted on building a perfect healthcare system. It was moderated by Dr. Vijay Raghavan, Associate Director, PwC India. The panel members included Dr. Mudit Saxena, Group CEO, Care Hospitals; Mr. Rohit M A, MD, Cloudnine Hospitals; Mr. Prashant Jhaveri, Chief Business Officer, Medi Assist; Mr. Suresh Ramu, CEO, Cytecare Hospital and Dr. Shubnum Singh, Director, Max Healthcare Institute.  “There is a huge disparity in terms of the availability of clinical facilities. According to the World Health Organization (WHO) and the ministry of health, India has seven doctors per 10,000 people. We need to achieve a modest doctor-to-population ratio in our country. As a result many more doctors and healthcare professionals are required in the years to come”, shared Mudit Saxena, Group CEO, Care Hospitals. ]]> https://biospectrumindia.com/news/97/9978/merck-in-collaboration-with-genea-biomedx-got-fda-510k-permission-for-benchtop-embryo-incubator-geri-.html https://biospectrumindia.com/news/97/9978/merck-in-collaboration-with-genea-biomedx-got-fda-510k-permission-for-benchtop-embryo-incubator-geri-.html Wed, 06 Dec 2017 13:00:00 +0530 Leading healthcare science and technology company, Merck, announced the FDA 510(K) clearance of the benchtop embryo incubator Geri. This innovative technology, designed to improve processes in fertility laboratories, will be commercially available to IVF clinics in the U.S. in the first half of 2018. Merck will help to advance assisted reproductive treatment (ART) technologies by offering new, relevant solutions to patients and their healthcare professionals. "Geri is one of the flagship products of our fertility technologies portfolio and has been successfully used in clinics across Australia, Europe and Asia for the last two years," said Rehan Verjee, Chief Marketing and Strategy Officer at Merck's biopharma business. "Offering Geri in the U.S. will allow us to further our aspiration of becoming an integrated fertility treatment partner, continuously aiming to improve treatment outcomes." stated Rehan Verjee  An incubator is critical for embryo development while it is being cultured outside of the uterus. Getting as close as possible to in-vivo incubation conditions is essential to ensure the most favorable environment for embryonic development, given that exposure to non-optimal conditions outside of an incubator may affect the viability and quality of embryos. Geri was designed by embryologists who know the lab processes and what optimizes successful embryo growth. Geri has six individual chambers, each independently controlled, facilitating the care of the embryos of six patients at the same time. It is equipped with high-definition cameras to take a picture of the embryos every 5 minutes and provide continuous imaging. With the help of these images, supervising embryologist can observe embryos as they develop without removing them from their optimum environment. This minimizes lid openings and potential disruptions that can cause stress to embryos.  "Genea Biomedx is an IVF medical device company uniquely positioned within a clinical fertility business allowing it direct access to world leading IVF laboratories. This enabled us to develop Geri in collaboration with the embryologists that use it day in, day out," said Dr. Tammie Roy, General Manager at Genea Biomedx. "We are looking forward to working with EMD Serono to bring our innovative technology to clinics across the U.S."  With the exception of Australia, Geri is distributed by Merck through its Fertility Technologies unit, in accordance with a global distribution agreement executed with Genea Biomedx in May 2015.   ]]> https://biospectrumindia.com/news/97/9974/lia-diagnostics-got-fda-approval-for-the-first-and-only-flushable-biodegradable-pregnancy-test.html https://biospectrumindia.com/news/97/9974/lia-diagnostics-got-fda-approval-for-the-first-and-only-flushable-biodegradable-pregnancy-test.html Wed, 06 Dec 2017 11:10:00 +0530 Lia Diagnostics, Inc. announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter use of the Lia Pregnancy Test, the first and only FDA-cleared, flushable, biodegradable pregnancy test. Lia features a proprietary coating technology, combined with nonwoven and paper techniques, that eliminates the need for plastic, creating a new category of water-dispersible, eco-friendly diagnostics. Lia is more than 99% accurate when used on the day of your expected period.It is the result of years of research that combines the desire for discretion with sustainable materials and novel engineering into a pregnancy test that doesn't harm the earth. Lia Diagnostics develops and commercializes water-dispersible, biodegradable diagnostic kits and products. Founded by women based in Philadelphia, the company prides itself on modernizing and humanizing reproductive health and wellness products. The company designs single-use diagnostics with the consumer and their unmet needs in mind, ensuring each product is both consumer and environmentally friendly. ]]> https://biospectrumindia.com/news/97/9968/tiny-robots-enhance-the-chances-of-surgical-interventions.html https://biospectrumindia.com/news/97/9968/tiny-robots-enhance-the-chances-of-surgical-interventions.html Tue, 05 Dec 2017 17:05:00 +0530 Maker of novel robotic solutions, Medical Microinstruments S.r.l. (MMI) discloses its robotic platform specifically designed for open microsurgery. The platform allows the surgeon to control two tiny articulated microinstruments that simplify reconstruction procedures after traumatic injuries as well as after tumor removal in soft tissue and bones, and offers the potential for improved surgical success rates and patient outcomes.  MMI's instruments are equipped with the smallest articulated wrist having a 3-millimeter outer diameter and tips just 150 micron in width. The wrist is the key to performing robotic microsurgery in real clinical settings and allows easy manipulation of small sutures, from 9-0 to 12-0 in size. "Thanks to the use of advanced materials and novel microfabrication processes, we have designed the smallest articulated wrist to provide microsurgeons unique instrument dexterity and robotic precision," said Massimiliano Simi, Co-founder and VP R&D.  The surgeon operates the microinstruments while sitting at the surgical bedside and looking through the operating microscope. MMI's robotic platform captures surgeon's hand movements and a scaled-down motion is imposed on the microinstruments.  "We have developed this groundbreaking technology together with microsurgeons from the product's conception and the positive feedback and response that we've received along the way has really been overwhelming and led us to believe that we are on the right track in developing a robot by and for microsurgeons," said Hannah Teichmann, Co-founder and VP Clinical.  Prof. Marco Innocenti, Chief of Plastic and Reconstructive Microsurgery at Careggi University Hospital in Florence and MMI's Clinical Advisor, who has presented preclinical work with MMI's robot at 9th Congress of World Society for Reconstructive Microsurgery in Seoul, including 0.35mm arterial robotic anastomosis. According to him, the MMI robotic platform will push the frontier of microsurgery forward and beyond the capabilities of the human hand, thus allowing more surgeons to perform more complex procedures but also enabling supermicrosurgery, such as lymph reconstruction, for the more expert ones. In a surgery conducted by surgical robots, the incision is small, the loss of blood is very minimal, and the patient has quick recovery, shorter hospital stays and a faster return to normal life. MMI's President and Co-founder, Giuseppe Maria Prisco, estimates the potential annual market opportunity to be in the order of $2.5 billion. ]]> https://biospectrumindia.com/news/97/9941/ricoh-meg-measurement-system-has-received-510k-approval-from-usfda.html https://biospectrumindia.com/news/97/9941/ricoh-meg-measurement-system-has-received-510k-approval-from-usfda.html Fri, 01 Dec 2017 14:30:00 +0530 Ricoh, headquartered in Tokyo, made an announcement that the RICOH MEG Measurement System has received 510(k) clearance from the U.S. Food and Drug Administration RICOH MEG, Ricoh's magnetoencephalography system, is a noninvasive way to detect faint signals within the brain. It provides deeper measurement (hippocampus and hypothalamus), clearer signal using coaxial gradiometer sensors and greater patient comfort for better data acquisition. "Ricoh is committed to helping advance research and treatment for neurological disorders and MEG is another tool to help healthcare professionals and researchers measure brain activity," said Scott Abelson, Business Development Director, Medical Imaging, Ricoh USA, Inc. Ricoh entered the medical device industry when it acquired a portion of a Yokogawa Electric business in 2016. Ricoh is empowering digital workplaces using innovative technologies and services enabling individuals to work smarter. ]]> https://biospectrumindia.com/news/97/9921/apollo-hospitals-offer-new-diagnostic-services.html https://biospectrumindia.com/news/97/9921/apollo-hospitals-offer-new-diagnostic-services.html Wed, 29 Nov 2017 14:55:00 +0530 India’s largest integrated healthcare provider, Apollo Hospitals Group, has recently partnered with Colombo-based Credence Genomics. As part of this association, Apollo has announced the launch of a portfolio of cutting edge diagnostics services for infectious diseases. The new line of tests is based on a specialized DNA diagnostics platform offering faster and more precise diagnosis. Through this partnership, Credence Genomics’ flagship products, the Rapid Infection Detection (RID), Bactfast and Fungifast, will now be readily available to benefit patients and assist the medical fraternity in India by offering fast and precise diagnosis for infectious diseases. The diagnostic products Credence RID, Bactfast and Fungifast are diagnostic tests which can diagnose any infectious disease caused by a bacteria or fungi with over 90 per cent accuracy. Credence Genomics is a Sri Lankan establishment pioneering in the development of leading-edge innovations on specialized DNA diagnostics based on the next generation sequencing platform with intensive research infrastructure and capabilities. Credence Genomics will be setting up a state-of-the-art DNA research diagnostics facility in Chennai. The facility will be managed by a team of leading scientists from all across India and will be fully operational by mid-December. ]]> https://biospectrumindia.com/news/97/9892/expansion-of-philips-healthcare-at-home.html https://biospectrumindia.com/news/97/9892/expansion-of-philips-healthcare-at-home.html Mon, 27 Nov 2017 13:25:00 +0530 Philips India Ltd, a high quality health service provider, has announced the expansion of its Healthcare@home services beyond Respiratory and Critical care, providing high-quality and extensive range of health care facilities at home.  The new customised services will be supported by cutting-edge healthcare devices, patient monitoring systems and developed in consultation with India’s leading doctors and hospitals. The new service will be provided across NCR, Mumbai, Hyderabad and Bengaluru, with further plans to reach out to 5 more cities by year end. Philips is a leading player in health systems and connected devices. Over the last few months it has successfully introduced ICU@home across 4 cities in India. It helps to bring a hospital like ICU set up at home, making things easier for both the patient and care givers. These ICU@home set ups are powered by technologically advanced devices, manned by ICU trained nurses and under constant remote supervision of a doctor. Philips is now expanding its service offerings to serve a wider patient base in both short term (non-chronic) and long term (chronic) care segments. The new care areas, which will be provided by its expert care givers in comfort of patient’s home, include palliative care for short and long term treatment, post-operative care, elderly care and drug infusion therapies. It will minimize the need for hospitalization for various diseases, wound therapy, Doctor on call, and various rehab services. Most of these services will be backed by its connected care platform, making remote monitoring possible and driving availability of hospital like care at home.  Richa Singh, Business Leader Philips Healthcare@home, India said “India by 2050, is expected to have 1 in 5 people over 50 years of age. The opportunity is immense and Philips is uniquely positioned to help transform care delivery, backed by its expert care team of doctors, paramedics and technically advanced connected care devices”.  Philips has always focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment, and home care. With Philips’ Healthcare@home services, a patient undergoes treatment in the comfort of his home, reducing stress and disruption for the family of multiple hospital visits and long commutes. The treatment at home is much more cost effective and also helps in speedier recovery with minimised risk of secondary infections.       ]]> https://biospectrumindia.com/news/97/9886/achievement-of-biotech-company-treat-burns-with-pineapples.html https://biospectrumindia.com/news/97/9886/achievement-of-biotech-company-treat-burns-with-pineapples.html Fri, 24 Nov 2017 16:50:00 +0530 Nasdaq-listed, Israel-headquartered biotechnology company MediWound Ltd. is attempting to revolutionize the way doctors treat second and third-degree burns. To do so, it is using a patented technology first discovered by a German military doctor during the Second World War, which involves the topical application of pineapple plant enzymes to burn wounds.  Founded in 2001 in Yavne, 18 miles south of Tel Aviv, MediWound develops, manufactures and commercializes treatments for severe burns and chronic wounds. The company’s flagship product is a pineapple enzyme-based treatment used for the removal of dead tissue from burn wounds called NexoBrid. The gel preparation kit is compiled of two vials, one containing enzymes from powdered pineapple tree trunks, the other containing a water-based gel. The two are designed to be combined just before application on the skin. The gel is effective in removing only the dead tissue, possibly minimizing the need for surgical procedures.  MediWound CEO Gal Cohen narrates that, German military doctor called Jerry Klein who was stationed in North Africa in World War Two. In US He met an American doctor, and the two began collaborating in the research of the medicinal properties of pineapple enzymes when applied to burns.  The research evolved throughout the 1960s and 1970s, but the two were unable to isolate and control the levels of enzymes well enough to assure a consistent, marketable medication can be produced. Israeli plastic surgeon Lior Rosenberg took on Mr. Klein’s research after meeting him at a conference in Switzerland in the 1980s. For over two decades Mr. Rosenberg researched and experimented with pineapple enzyme-based treatments and in 2001 he founded MediWound. “It took us 12 years from the moment we founded the company to receive marketing approval,” Gal Cohen, Mediwound CEO said. NexoBrid was approved for marketing in Europe in 2012 and Israel in 2013.  NexoBrid is intended as a replacement for surgical procedures. There are no other non-surgical treatments that achieve what NexoBrid does, Mr. Cohen said. Since the 1970s, doctors learned that the only way to treat severe burns is to surgically remove the dead tissue. “We are trying to change a medical paradigm, and that is a great challenge,” Mr. Cohen added.  NexoBrid had its moment in the spotlight in October 2015, when more than 150 people suffered severe burns following a fire at a Bucharest, Romania nightclub. MediWound sent two doctors and a supply of NexoBrid kits to aid local doctors. “The aid Mediwound sent Romania was practical proof of NexoBrid’s ability to serve as a central treatment for multi-casualty events,” said Mr. Cohen, who added that NexoBrid was used to treat over 50 burn victims in just three days.  More than half of the burn centers in European hospitals now use NexoBrid, Mr. Cohen said.In January, Mediwound announced its expansion into Latin America through an exclusive agreement with Avalon Pharmaceutical S.A.  MediWound will announc an agreement with Taiwanese biotech company Holy Stone Healthcare, Co., Ltd. for the distribution of NexoBrid in Taiwan. The companies plan to commercialize NexoBrid in Taiwan after getting regulatory approvals, expected to be granted within two years.  “This agreement is part of our strategy to expand the use of NexoBrid to international markets by collaborating with local companies that take the responsibility for and possess the expertise in local regulatory, market access and marketing efforts,” said Gal Cohen.  “Evidenced-based clinical studies and growing experience reported by numerous experts treating patients in routine and mass casualty events demonstrate that NexoBrid will play a major role in the future of burn care,” said Albert Wu, Chief Executive Officer of Holy Stone.  In addition to Europe and South America, NexoBrid is also marketed in Japan, South Korea, and India.  MediWound still awaits FDA approval. The company expects to begin a U.S. Phase III clinical trial and a pediatric Phase III study next year. All of NexoBrid U.S. research and registration process is funded by federal agency Biomedical Advanced Research and Development Authority (BARDA). In July, BARDA increased the funding for MediWound by $32 million, for a total of $56 million.  Mr. Cohen suggests that the main challenges NexoBrid is facing are the slow pace in which treatment protocols get changed, and the bureaucracy involved in obtaining insurance coverage for the drug. Still, he said, there is no surgical capacity to treat burn victims from multiple casualty incidents, not in Israel or anywhere else in the world, which should ultimately spell success for MediWound.  Oppenheimer & Co Inc.’s biotech analyst Akiva Felt agrees and said “NexoBrid is well positioned to gain a substantial share of the burn treatment market, due to its many advantages and its impressive clinical effectiveness”.       ]]> https://biospectrumindia.com/news/97/9877/biocon-launches-krabeva-to-treat-cancer-.html https://biospectrumindia.com/news/97/9877/biocon-launches-krabeva-to-treat-cancer-.html Thu, 23 Nov 2017 16:15:00 +0530 Biocon Ltd, Asia's premier biopharmaceuticals company, has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India. KRABEVA, a monoclonal antibody (mAb) developed by Biocon, will help expand access to a world class, high quality biosimilar Bevacizumab for cancer patients in India. It is the world’s first and only Bevacizumab with a unique ‘Qual-Check’ mechanism, which will ensure that patients get a quality-ascertained product right up to infusion.  Bevacizumab is indicated as a first-line treatment of patients with metastatic colorectal cancer (mCRC).It is accepted as a standard treatment option in combination with chemotherapy for patients with non-small-cell lung cancer (NSLC), metastatic renal cell carcinoma and recurrent ovarian cancer. Dr Arun Chandavarkar, CEO & Joint Managing Director, Biocon said: “With KRABEVA we intend to provide a high quality, world-class biosimilar Bevacizumab as an affordable therapy option for patients of various types of cancer. We believe KRABEVA will be an important addition to our Oncology portfolio of novel biologics as well as biosimilars, which are making a significant impact in the realm of cancer care in India.” KRABEVA is the second key oncologic biosimilar product from Biocon’s global biosimilars portfolio to be launched in India, in order to address the unmet patient need for affordable biological therapies. It is being offered to patients at an MRP of Rs 24,000 for 100 mg / 4 ml vials and Rs 39,990 for 400 mg / 16 ml vials, making it a high quality affordable alternative to the innovator brand. KRABEVA is being launched post successful completion of Phase III clinical trials and approval of Biocon’s Marketing Authorization Application by the Drug Controller General of India (DCGI). Most biologic products require a specific storage condition to maintain the safety, purity and potency of the drug. An efficient and seamless cold chain prevents denaturation of antibodies due to heat. KRABEVA is being introduced with an innovative temperature-sensitive packaging that includes thermo-chromic stickers, which change colour irreversibly if the cold chain temperature is not maintained. This first-of-its-kind ‘Qual Check’ feature ensures quality check of the product up to the point of administration to the patient. This will provide greater confidence to pharmacists, nurses and caregivers about the quality of the product they are dispensing and will enable better patient safety.   Biocon’s biosimilar Bevacizumab has been developed for global markets with a clear focus to meet strict quality and regulatory requirements and provide access to a high quality biosimilar to patients. The Phase III clinical study involving 146 patients of mCRC, has been conducted after obtaining regulatory approvals in India. The extrapolation to other indications has been approved by the DCGI.  The global Phase III trial in non-small-cell lung cancer (NSLC) patients is being conducted at more than 100 sites across multiple countries using an EU and US sourced reference product. Prior to this, a three-way Phase I PK study in healthy volunteers was conducted in Europe.  Bevacizumab is a monoclonal antibody (mAb) targeting Vascular Endothelial Growth Factor- A (VEGF-A), a   cell protein that induces growth of blood vessels that feed tumors.  By blocking this protein, Bevacizumab cuts the supply of food and oxygen to the tumor, thus starving it.  Bevacizumab is prescribed in the treatment of several cancers including metastatic colorectal cancer, ovarian cancer, advanced non-small-cell lung cancer, recurrent glioblastoma, cervical cancer and renal cancer.  The launch of KRABEVA, biosimilar Bevacizumab, comes at a time when the incidence of cancer is projected to reach alarming numbers, with over 17.3 lakh new cases of cancer and over 8.8 lakh cancer deaths projected in India by 2020 as per the Indian Council of Medical Research (ICMR).  An estimated 64,000 cases of colorectal cancer were diagnosed and 49,000 deaths recorded due to the disease in India, according to GLOBOCAN’s 2012 estimates of the worldwide incidence and mortality from cancers. There were an estimated 1.14 lakh new lung cancer cases in India in 2016 and the number is projected to grow to 1.40 lakh by 2020, according to ICMR. Similarly, new cervical cancer cases are expected to rise from an estimated 1 lakh in 2016 to about 1.04 lakh by 2020.  Global sales of the innovator product in 2016 were pegged at USD 6.9 billion. The market size for Bevacizumab, both innovator product and biosimilar, in India is estimated at Rs. 177 Crore (USD 27 million), according to IPSOS June MAT 2017 data.     ]]> https://biospectrumindia.com/news/97/9872/samsung-india-teams-up-with-up-govt-for-healthcare.html https://biospectrumindia.com/news/97/9872/samsung-india-teams-up-with-up-govt-for-healthcare.html Thu, 23 Nov 2017 11:40:00 +0530 A Memorandum of Understanding (MoU) has been signed between Samsung India and the Department of Medical Health & Family Welfare, Government of Uttar Pradesh in the presence of Siddharth Nath Singh, Minister of Medical and Health, Government of Uttar Pradesh, recently. Prashant Trivedi, Principal Secretary, Department of Medical Health & Family Welfare, Government of Uttar Pradesh, V. Hekali Zhimomi, Secretary, Medical Health & Family Welfare Department, Dr. Padmakar Singh, Director General, Medical & Health Services, Government of Uttar Pradesh and other dignitaries were also present for the signing. This collaboration will lead to addition of 20 new Samsung Smart Healthcare centres across the state and provide affordable and quality healthcare to patients from the economically and socially weaker sections of society. As part of its Smart Healthcare programme, Samsung will provide advanced and innovative healthcare equipment such as ultrasound and digital radiology (x-ray) machines manufactured by the company along with a Samsung LED TV, Samsung air conditioner and refrigerator to selected government hospitals across the state. Samsung Smart Healthcare programme aims to support the Government’s efforts to benefit communities with limited access to quality healthcare. With innovative products such as ultrasound, digital radiology and accessories that facilitate healthcare intervention and multiple medical examinations, since 2015, Samsung has collaborated with 18 government hospitals across to country for the Samsung Smart Healthcare programme. ]]> https://biospectrumindia.com/news/97/9860/clinimacs-prodigy-system-a-breakthrough-approach-for-cancer-patient.html https://biospectrumindia.com/news/97/9860/clinimacs-prodigy-system-a-breakthrough-approach-for-cancer-patient.html Tue, 21 Nov 2017 17:25:00 +0530 As per the analysis, doctor says that 70% of blood cancer patients were left with no donors. For many patients with blood cancers like leukaemia’s, lymphomas & Thalassemia; Bone marrow transplantation is a life-saving therapy. Medical oncologist follows the standard blood-generating stem cells protocols that are obtained from a donor, a sibling, with a 100 % perfect match to the patient in order to minimize the chance of rejection and other complications.  It has observed that, not all patients will have a perfectly matched sibling, hence treatment get delayed due to wait for exact match. Dr Pradeep Mahajan, Regenerative medicine researcher, StemRx introduces CliniMacs prodigy System giving hopes for cancer patient for bone marrow transplant with un-matched donor.  For the first time in India a cell manufacturing system that will cater to the requirements of clinical Haemato-Oncologist to address the patients’ needs for malignant and non-malignant transplants. More than 5000 patient benefited through CliniMACS Prodigy System all across the world. This will help those with cancer and genetic diseases to easily avail transplantation. Opting for an alternate transplant donor will be easy with this technique, benefitting many patient suffering from leukaemia or other cancers.  During the medical conference organised at Seven Hills Hospital, Mumbai; Dr Pradeep Mahajan, Regenerative medicine researcher, StemRx introduce “CliniMACS Prodigy System” said “It was not possible to opt for a transplant unless the perfect blood cells match, however with the inclusion of this new technique half matched transplant is also possible. It can eliminate long waiting periods for BMT donor & save many lives. It is a certified GMP-grade cell manufacturing system that involves reprogramming of DNA immune system cells called T cells so that they attack the tumour in the body.” At the launch, renowned doctors and medical specialists discussed on various clinical advantages related to CliniMACS Prodigy system. Dr. Sunil Bhatt, Head of Department Paediatric Haematology, Oncology and Bone Marrow Transplant at Narayana Health City, Bangalore said, “Initially it was mandatory that blood cells from siblings needs to be matched for transplant. This led to only 25 to 30% chances of finding a perfect match and 70% of patients were left with no donors. However, with this new technique alternate donor transplant from blood relatives that match half is also possible. This increases the option of finding a treatment for Cancer patients.”  Dr. Meenakshi Sing, Scientific Officer, ‎Department of Transfusion Medicine Tata Memorial Hospital, said, “The role of natural killer cells in stem cell transplant has a positive impact on cancer, acute leukaemia, solid or liquid tumour patients as cells induce removal of residual leukaemia cells in cancer patients.”  Dr Minal Poojary, Blood Bank Officer, Tata Memorial Hospital, said, “There are various types of transplant with various risks and advantages. As per the condition of the patient the collected cells are modified. The processing of these cells is as per indication from the doctor and the patient’s needs.”  Dr Pradeep Mahajan said “Extracting stem cells from the bone marrow is a painful & risky for the donors who can sometimes require blood transfusions. The two step method uses stem cells harvested from the blood of siblings.  Using the stem cells from blood is not only easier for donor, but also gives doctors the ability to control the exact number of immune cells called T cells, which fight the cancer. “ “Patient suffering from cancer has to undergo chemotherapy, that helps keep those cell from becoming over reactive followed by cancer fighting T cells. CAR- T cell immunotherapy shows strong promise for treating various cancers and infectious diseases,” Added Dr Mahajan. “The procedure will be carried under the guidance of expert medical oncologist & clinician said Dr Mahajan. ]]> https://biospectrumindia.com/news/97/9856/maha-govt-centre-to-join-hands-for-developing-apis-device-parks-at-mihan-nagpur.html https://biospectrumindia.com/news/97/9856/maha-govt-centre-to-join-hands-for-developing-apis-device-parks-at-mihan-nagpur.html Tue, 21 Nov 2017 13:45:00 +0530 Maharashtra Chief Minister Devendra Fadnavis and Union Minister for Road Transport, Highways and Shipping Nitin Gadkari are scheduled to discuss an action plan in Mumbai shortly for developing bulk drugs and medical devices park at Multi-Model International Cargo Hub and Airport at Nagpur (MIHAN) through a collaborative approach. As a part of its policy of ease of doing business, center is planning to develop multi-product Special Economic Zone (SEZ) at MIHAN.Both the ministers are scheduled to discuss modalities and explore areas of investment for setting up common facilities of manufacturing and testing in consultation with pharma industry, according to an official associated with the development. This comes close on the heels of Maharashtra Food and Drug Administration (FDA) holding talks with pharmaceutical companies in Nashik, Aurangabad, Mumbai, Pune and Thane to explore investment opportunities for developing pharma hub at Multi-Model International Cargo Hub and Airport at Nagpur (MIHAN) multi-product Special Economic Zone. According to officials, 1000 acres of land in MIHAN SEZ is likely to be developed for API production, which will boost exports and deemed exports. Meanwhile, a technical feasibility study is also underway for setting up of medical device park at MIHAN which will also be equipped with common facilities for testing and manufacturing competencies on par with Andhra Pradesh Med Tech Zone (AMTZ) at Visakhapatnam in Andhra Pradesh. The MIHAN management is also in the process of earmarking the land, land rate and formulating policies on the same for developing medical device park. Currently, medical device manufacturing by few players have also started at MIHAN. These ongoing developments which are also in the interest of domestic industry is supplemented by the coming up of institutions like All India Institute of Medical Sciences (AIIMS) in an area of 150 acres in the coming years and Indo UK Medicity in an area of 152 acres at MIHAN. This will pave the way for development of pharma and life sciences cluster in the country.  The Indo-UK medicity currently being run in coordination with King’s College London for treating foreign patients is aimed at giving boost to medical tourism which will bring in foreign investments. Setting up of a medical device park at MIHAN, Nagpur has been deliberated comprehensively between MIHAN management team and medical device associations.  Seeing the potential in terms of investment and business prospects, the Maharashtra Airport Development Company Ltd (MADC) is inviting pharmaceutical companies to set up their units in MIHAN project. The project will have a dedicated zone along with certain benefits for the pharmaceutical companies setting up their units in the project. The multi product Special Economic Zone in MIHAN is sought to be developed for both API and formulations. These units will have the benefits of duty free import or domestic procurement of goods for development, operation and maintenance of SEZ units; 100 per cent income tax exemption on export income for SEZ units for the first 5 years, 50 per cent for the next 5 years thereafter and 50 per cent of the ploughed back export profit for the next 5 years; external commercial borrowing (ECB) by SEZ units up to US$ 500 million in a year without any maturity restriction through recognized banking channels; exemption from central sales tax; exemption from service tax; single window clearance for central and state level approvals; exemption from state sales tax and other levies as extended by the state government and 100 per cent FDI is being allowed. ]]> https://biospectrumindia.com/news/97/9838/india-and-canada-jointly-venture-out-in-medical-electronics.html https://biospectrumindia.com/news/97/9838/india-and-canada-jointly-venture-out-in-medical-electronics.html Fri, 17 Nov 2017 15:10:00 +0530 Global Innovation & Technology Alliance, GITA, of India and Global Affairs Canada, have awarded funding to Unique Broadband Systems Ltd, UBS, of Toronto, Ontario, Canada and Kaynes Technology of Mysore, India for the co-development and co-marketing of High Power RF Amplifiers for Low Field Magnetic Resonance Imaging, MRI, Applications. The project falls under the Program category of Affordable Healthcare, Electronic System Design and Manufacturing (ESDM). Working together, the Governments of Canada and India aim to foster and support collaborative industrial R&D projects with high potential for commercialization. The Canadian International Innovation Program (CIIP) is delivered in partnership with the National Research Council of Canada’s Industrial Research Assistance Program in India. Regarding this project, UBS will design the high power RF circuitry and signal processing electronics, while Kaynes will provide the packaging and manufacturing expertise required for the creation of high performance, high reliability amplifiers, which will be used in both new and legacy MRI scanner installations. The project is expected to commence in November, 2017 and be completed by early to mid-2019. ]]> https://biospectrumindia.com/news/97/9798/amtz-and-admi-strike-a-strategic-partnership.html https://biospectrumindia.com/news/97/9798/amtz-and-admi-strike-a-strategic-partnership.html Mon, 13 Nov 2017 11:45:00 +0530 Andhra Pradesh MedTech Zone (AMTZ) has signed a Memorandum of Understanding (MoU) with the Association of Diagnostic Manufacturers of India (ADMI) for improving access to technological, investment opportunities, and help build strategic, long-term partnership between ADMI and AMTZ. The MoU was signed by Dr. Jitendar Sharma, CEO, AMTZ and Dr. D. K. Joshi, President, ADMI, during the recent quarterly meeting of members of ADMI at Mumbai. As per the MoU, AMTZ and ADMI will work together to identify and add Harmonized System (HS) codes for IVD products. This will enable easier classification of IVD products and reduce complexity during their trade. AMTZ with its one-stop solution across infrastructure, scientific facilities, regulatory help desk and preferential market access is enabling the entire ecosystem for medical devices while ADMI with its focus and expertise in IVD devices will partner to promote the standards of the IVD industry in India. ADMI which represents companies from the Indian IVD industry will be setting up an office at AMTZ. It will also be contributing towards the proposed National Medical Device Promotion Council (NMDPC) to promote industry and assist with trade barriers. Kalam Institute of Health Technology (KIHT) which is currently hosted by AMTZ will partner with ADMI to enable technology transfer, focused research and development in the IVD sector. AMTZ has been allotted 270 acres to become a hub for ultra modern medical equipment manufacturing. The project is envisaged to attract at least 200 units with an estimated investment of Rs.25,000 crore to Rs.30,000 crore and job opportunities for 25,000 people.   ]]> https://biospectrumindia.com/news/97/9775/health-ministry-to-release-indigenous-tb-test.html https://biospectrumindia.com/news/97/9775/health-ministry-to-release-indigenous-tb-test.html Tue, 07 Nov 2017 11:10:00 +0530 An indigenously developed diagnostic test called Truenat test for effective case detection of Tuberculosis (TB) will soon be rolled out by the Union Health Ministry. Multi-centric studies have been carried out to validate this point-of-care (POC) molecular diagnostic test. It has also been found to be comparable with internationally approved molecular diagnostic tests, as stated by the country’s apex research body—Indian Council of Medical Research (ICMR). The Tuberculosis Research Consortium (ITRC), formed by the ICMR, convened its second International Scientific Advisory Group (ISAG) meeting this week in New Delhi. While a Cartridge-based Nucleic Acid Amplification test (CBNAAT) has been successfully rolled-out as a tool to detect drug resistance, it remains expensive and largely inaccessible as a front-line TB test. India has relied heavily on smear microscopy technology (the traditional, manual Sputum smear diagnosis of TB) for decades, and case detection continues to be a major gap in the cascade of care. ISAG suggested that all patients testing positive for TB by POC test, may also be tested by another nationally endorsed rapid test for diagnosing drug resistance TB. The committee also recommended a cost-effectiveness analysis and optimization of the POC test for rifampicin (commonly used antibiotic to treat TB) resistance. ]]> https://biospectrumindia.com/news/97/9769/us-researchers-develop-an-effective-heart-device-.html https://biospectrumindia.com/news/97/9769/us-researchers-develop-an-effective-heart-device-.html Fri, 03 Nov 2017 15:20:00 +0530 The Harpoon Mitral Valve Repair System (H-MVRS) is an image-guided device based on technology developed at the University of Maryland School of Medicine (UMSOM). A new study has found that the pioneering device to repair heart valves is safe and effective, and can reduce the invasiveness and side effects of conventional mitral valve surgery.  The device allows the surgeons to precisely and effectively reduce the degree of mitral regurgitation without using an open-heart procedure.  Surgeons insert the device into the beating heart through a tiny opening in the ribcage and, using echocardiographic imaging, guide it to the surface of the defective mitral flaps. When the surgeon determines the optimal placement for an artificial cord, the device is actuated and a specially designed needle makes a tiny hole and sends the cord material through the flap.  The device was previously tested in Poland. U.S. testing of the device may begin in 2018. The faculty at UMSOM has increasingly engaged in entrepreneurial and technology transfer activity, with significant increase in the number of U.S. and foreign patents issued, technology inventions licensed and start-up companies formed. ]]> https://biospectrumindia.com/news/97/9761/medequip-launches-new-sleep-apnea-therapy-devices.html https://biospectrumindia.com/news/97/9761/medequip-launches-new-sleep-apnea-therapy-devices.html Thu, 02 Nov 2017 12:30:00 +0530 Medequip Healthcare Solutions, a Bengaluru based importer and manufacturer of healthcare products launches Hypnus Oxymed CPAP and BiPAP devices for sleep apnea therapy. “The focus of Medequip is to reduce the healthcare cost in the next 5-10 years, make it affordable and accessible to all. Domestic manufacture of customized indigenous medical devices will allow us to reduce end user costs.” states Ankur Garg, Co-founder, Medequip Healthcare Solutions. Sleep apnea is one of the most prevalent sleep disorders. It is most often caused by an obstruction in the respiratory tract, preventing air from entering the lungs. People with untreated sleep apnea choke during their sleep and even wake up due to this, which disrupts the sleeping pattern. The disruption in supply of air deprives the brain and the rest of the body of enough oxygen leading to very serious consequences, including high blood pressure, heart disease, diabetes and obesity. Delivering a steady flow of air into the airway is an effective solution. “We are committed to raising sleep apnea awareness, so that people who suffer will seek treatment. Our mission is to provide quality homecare products that will improve our customers’ quality of life” said Suhas Shubhakaran, Co-founder of Medequip. He further added "We are ready with a plan to set up a manufacturing facility in Bangalore in 2018, supporting the Make in India initiative”. Hypnus Oxymed automatically adjusts supply pressure to guarantee natural breathing. It monitors the users breathing to ensure effective exhalation and inhalation using an intelligent algorithm. The efficient humidification technology brings an increase in relative humidity making every breath warm, humid & comfortable. It also captures and records the patients sleeping data precisely for around 2 years. ]]> https://biospectrumindia.com/news/97/9738/lumenis-india-launches-moses-holmium-laser-technology-for-urology-.html https://biospectrumindia.com/news/97/9738/lumenis-india-launches-moses-holmium-laser-technology-for-urology-.html Mon, 30 Oct 2017 11:25:00 +0530 Energy based medical device company, Lumenis Ltd recently launched the path breaking  Moses holmium technology for Urology applications in India. Millions of people around the globe and in India are suffering from different kind of stone related problems in their lifetime. Having stones in Urinary system is a common problem. Kidney stones, Ureteric stones and Bladder stones are the three most common types of stone formations that take place. This technology is designed to significantly reduce retropulsion during lithotripsy, enabling significantly minimised stone migration and a more efficient procedure. Moses technology includes a proprietary combination of holmium laser system and fibers that optimize holmium energy transmission allowing the surgeon more control regardless of the working distance between the fiber and the stone. All this, allows surgeons to treat stones in difficult to reach locations, and enables smooth initial fiber insertion through a fully deflected scope. Dr. Khurshid Ghani, Associate Professor of Urology, University of Michigan, said: “I am very excited to be one of the first physicians worldwide to evaluate the new Moses Technology. In the first few cases I performed I noticed better control of the stone and less dependency on the distance of the fiber from the stone.” Dharmendra Mistry, Country Head, Lumenis India said “We are extremely proud to announce the launch of our new Moses Holmium technology here in India. It is a great privilege & honour to introduce this ground-breaking innovation, the result of decades of Holmium experience and generations of commitment to better technology for better patient care. With the advent of this new Moses Holmium technology it will be boon for the patients and the doctors for more easier and painless treatments. Bringing the new device is part of our expansion strategy as there has been a record number of patients suffering from urinary stones in India. Lumenis being the world’s largest energy-based medical device company we are dedicated to bring new innovations in the healthcare segment. Our aim is to provide superior and advanced technology to our doctors for better patient care”. Rashid Mokhdoomi, Senior Director Marketing, Lumenis India & South Asia, said “We are very excited to bring new Moses Holmium technology in India. This technology will enable doctors to perform procedures in a more convenient and controlled way”. “We endeavour to improve the outcomes for stone patients by delivering innovative, market-leading products and solutions”, he added.  The clinical experience confirms that Moses unique capabilities provide surgeons with better control during holmium lithotripsy procedures, including stone dusting and stone fragmentation. The data obtained shows a significant reduction in stone retropulsion that leads to a reduction in stone migration and more efficient lithotripsy procedures.     ]]> https://biospectrumindia.com/news/97/9736/esaote-launches-new-ultrasound-platform.html https://biospectrumindia.com/news/97/9736/esaote-launches-new-ultrasound-platform.html Fri, 27 Oct 2017 12:45:00 +0530 Esaote, an Italian medical diagnostic developer, has launched its new MyLab 9 ultrasound platform designed to deliver quality images, smart workflow and improved performance. The device includes upgradability, options for long-term maintenance, remote serviceability and compatibility for a transducer. The new ultrasound includes a touch-tool technology, easyMode, which eliminates complex technical operations and enables users to focus on patient examination. MyLab 9 comes with the firm’s i-motion technology that ensures high image quality and frame rate, along with fast boot-up and standby modes. The device features ergonomic Italian design, easy user interface, touchscreen, and different visualisation tools. It also supports various diagnostic imaging environments for enhanced productivity. The MyLab 9 eXP provides advanced diagnostic capabilities and clinical efficacy to respond effectively to the most demanding healthcare needs, expanding the access to innovative technologies for more customers. ]]> https://biospectrumindia.com/news/97/9691/imgenex-to-develop-diagnostic-kit-for-thalassemia.html https://biospectrumindia.com/news/97/9691/imgenex-to-develop-diagnostic-kit-for-thalassemia.html Thu, 19 Oct 2017 20:25:00 +0530 IMGENEX India Pvt. Ltd. is developing the first indigenous diagnostic kit for detection of mutations in common Indian beta thalassemia in collaboration with the National Institute of Immunohematology. It would be available soon through ICMR. The Bhubaneshwar based biotechnology company was founded by Dr. Sujay Singh in the year 2004. IMGENEX India has built a state-of-the-art R&D facility at the Infocity complex. Speaking to BioSpectrum, Dr Sujay Singh, CEO of the company said “At present, we are building a 14,000 sqft GMP facility in Bhubaneswar, Odisha for production of recombinant therapeutic antibodies and proteins using single use bioreactors.” Over the years IMGENEX India has received several grants from the Department of Biotechnology (DBT) that includes SBIRI grant to develop drugs for osteoporosis using nanotechnology based drug delivery. It is still in the early development phase. “In addition to this, Phase I and II grants from BIRAC have helped us to develop a high-expression mammalian expression system in CHO cells that is capable of producing 3-4 g per liter biosimilar Trastuzumab/Herceptin. We have shown the similarity of our antibody with innovator drug from Roche by biophysical characterization and functional studies. Our biosimilar trastuzumab will be ready for pre-clinical study at the end of 2017. Other biosimilars in the pipeline includes humira, avastin, embrel and stellara,” added Dr Singh. IMGENEX India is also developing and validating serological diagnostic reagents and kits for plant viruses affecting horticultural crops with ICAR-Indian Agricultural Research Institute under a CRS scheme. The main goal of IMGENEX India is to provide affordable healthcare to less privileged patients. It had received the Bio-Spectrum Asia-Pacific Emerging Company of the Year Award in 2011 by Bio-Spectrum Asia, Singapore and Emerging Company of the Year 2015 in Bio-industry sector in India by Bangalore Bio for its innovative work and high potential impact in the Biotech sector.   ]]> https://biospectrumindia.com/news/97/9662/mobile-health-app-medwatch-launched-by-indian-air-force.html https://biospectrumindia.com/news/97/9662/mobile-health-app-medwatch-launched-by-indian-air-force.html Fri, 13 Oct 2017 15:15:00 +0530 The Indian Air Force has launched an innovative mobile health App named ‘MedWatch’ on the ocaasion of its 85th anniversary. This is in synchrony with the Prime Minister’s vision of ‘Digital India’. The concept and content of the App is by the Directorate General of Medical Services (Air) and it has been developed in-house with zero financial outlay by the Directorate of Information Technology (DIT).  ‘MedWatch’, available on the IAF's AFCEL network, comprises a host of features that will provide authentic health information to all IAF personnel. A Reminder Tool to enable timely immunization for the children of all Air Warriors is an important component of the App. This will directly enable 'Mission Indradhanush' of the Govt of India.  ‘MedWatch’ is the first mobile health app in the three Armed Services and it was launched by Air Chief Marshal BS Dhanoa during the Air Force Commanders' Conference at New Delhi on 11 Oct 17.  ]]> https://biospectrumindia.com/news/97/9658/lumenis-introduces-first-ever-m22-opt-technology.html https://biospectrumindia.com/news/97/9658/lumenis-introduces-first-ever-m22-opt-technology.html Fri, 13 Oct 2017 10:40:00 +0530 Lumenis Ltd, the world’s largest energy-based medical device company for surgical, aesthetic and ophthalmic applications has launched its first ever Lumenis M22 OPT technology with Center for Sight in North India, in New Delhi. With an increasing use of gadgets like mobiles phones, laptops and computers workaholic people are more prone to dry eye syndrome. Studies show that humans generally blink about 22 times a minute. But when we concentrate on a computer screen or a smart phone or even while driving, the rate goes down to five or seven blinks per minute. If this tear film does not spread sufficiently across the eye, it can lead to dryness and irritation. “With the launch of Optimum Pulse Technology (OPT) for Dry Eye disease, Lumenis helps address this growing disease with our path breaking technology. Meibomian Gland dysfunction (MGD) is one of the leading causes of Dry Eye disease (DED), affecting millions worldwide. Optimal pulse technology from Lumenis has emerged as the most effective alternative for patients with MGD. OPT leads to significant improvement in ocular surface quality, gland function and dry eye symptoms” said Mr. Rashid Mokhdoomi, Senior Director, Marketing India and South Asia, Lumenis “We have also developed a Practice Enhancement Programs for Clinics; as we foresee rapid increase in demand for Dry Eye treatment with OPT technology. We continue to invest in our training and education platforms to ensure increasing number of patients benefit from the latest OPT technology” added Mr. Mokhdoomi. Dr. Mahipal S Sachdev, Chairman and Medical Director, Centre for Sight said “Technology has opened a new pathway for treating the patients who has to face a lot of problems related to the dry eye. Since, we always believed in bringing new technology to consumers, the new M22 OPT is infact a path breaking technology to the traditional used therapies”. The Lumenis M22 OPT is an excellent technology for treating eyelid inflammation. OPT is selectively absorbed in the hemoglobin of abnormal blood vessels, and destroys them by thrombosis. A major source of inflammation threatening the eyelids is then removed. It treats the root cause of the problem, provides immediate relief, a safe and comfortable, fast “lunch time” treatment and improves the skin appearance too. Experts say dry eye affects millions of adults. The risk increases with advancing age. ]]> https://biospectrumindia.com/news/97/9636/four-nations-joined-hands-to-launch-global-pathology-laboratory-consortium-.html https://biospectrumindia.com/news/97/9636/four-nations-joined-hands-to-launch-global-pathology-laboratory-consortium-.html Tue, 10 Oct 2017 12:20:00 +0530 With an aim of aggregating the fragmented diagnostic sector of the country, four nations joined forces to launch India’s first global Pathology Laboratory Consortium- Neuberg Diagnostics recently in Bangalore. It is founded by the renowned healthcare entrepreneur, Dr. G.S.K.Velu, the international alliance brings together leading laboratories from India, Sri Lanka, South Africa and UAE under one umbrella, making it one among the top laboratory chains of the country from the day one of its inception, both in footprints and revenue.  The conglomerate which has a combined diagnostic expertise of over two centuries is an alliance of laboratories like Anand Diagnostic Laboratory, Supratech Micropath, Ehrlich lab, Global labs and Minerva Labs, which have already made their presence in their respective countries and states such as Karnataka, Gujarat, Tamil Nadu, South Africa & UAE. The global brand was launched in the presence of Anupriya Patel, Minister of State in the Ministry of Health and Family Welfare, Dr Rajitha Senaratne, Minister of Health, Nutrition & indigenous Medicine, Sri Lanka, Dr Awatif Juma al Bahar, Medical director of Dubai Health Authority, UAE and Prof. Salim S Abdool Karim, Director of CAPRISA & Pro vice-chancellor, University of KwaZulu-Natal in Durban, South Africa along with the senior management officials of the brand.  Neuberg will have 3 world class global reference laboratories located in Bangalore, Ahmedabad, and Durban (South Africa) carrying out advanced range of testing using new generation In vitro diagnostics techniques along with total lab automation & big data analytics tools supported by robust world-class laboratory information system. These laboratories will have collective annual revenue of INR 400 crs with the formation of the new entity. Neuberg Diagnostics will operate under one corporate team headed by Dr. G.S.K.Velu as the Chairman, Anand K will assume the role of Chief Executive Officer while Dr. Sujay Prasad will be the Medical Director and Dr Sandip Shah will be the Executive Director. The Technical Board will comprise of pathologists like Dr Jayaram, Dr. Bhagyam Nair, Dr Lorna Madurai, and Dr Bhavini Shah among others. With full throttle growth expected to take up Indian diagnostics in the near term, the new generation consortium will pool in cutting-edge advanced diagnostics technology and actively perform 5000 plus variety of pathological tests, promoting prevention and early diagnosis, thereby empowering the Indian healthcare consumer. In conjunction with providing comprehensive laboratory services, covering all areas of laboratory medicine, Neuberg will combine conventional pathology testing, new generation laboratory techniques and basic Radiology & imaging techniques for enhanced patient outcomes. Dr. G.S.K.Velu, Chairman of Neuberg Diagnostics said, “The aim of the partnership is to develop a new shared services model for the provision of pathology services in the Middle East, Africa including west and South India. Neuberg Diagnostics is built on the vision to provide modern, innovative and sustainable services that deliver world-class lab facilities with the focus on high-end technology and services like Genomics and Proteomics to doctors and patients alike.” Anand.K, CEO of Neuberg Diagnostics said, “An association with the pathology experts will lead to the implementation of best practices, adoption of new technology and convert research into innovation, benefiting the medical community and ultimately improving patient care.” Speaking about the new venture, Anupriya Patel said, “Indian healthcare delivery is growing by leaps and bounds. A global consortium is therefore set to be a major platform to introduce new generation pathology services to the sector, thereby increasing the quality and affordability of the country’s healthcare services.” Dr. Hemantha Beneragama said, “This global alliance with the top pathology laboratories will help in strengthening our relationships with the neighboring nations.  Leveraging the expertise of world-class pathology brands, we look forward to leveling the existing gaps in our healthcare system.”       ]]> https://biospectrumindia.com/news/97/9564/carl-zeiss-launches-new-fundus-imaging-system.html https://biospectrumindia.com/news/97/9564/carl-zeiss-launches-new-fundus-imaging-system.html Thu, 21 Sep 2017 10:45:00 +0530 German firm Carl Zeiss Meditec has launched its next-generation ultra-widefield (HD UWF) fundus imaging system, CLARUS 500, in the US for high-definition (HD) retinal imaging. The new system features true colour imaging clarity from the macula to far periphery, allowing detection of ocular diseases. Colour accuracy is considered crucial for the diagnosis of ocular diseases as minute colour differences in optic disc, nevi and lesions might result in the alteration of disease diagnosis and management. Focal change assessment in rim tissue, nerve pallor, dry age-related macular degeneration RPE pigment changes and drusen is known to require precise colouration and resolution. The CLARUS 500 system is said to combine ultra-widefield view across the whole retina with high-quality conventional fundus photography that is used for optic nerve and macula imaging. CLARUS 500 technology enables easy review and comparison of images, while its annotation and caliper measurement tools facilitate in-depth eye health analysis. ]]> https://biospectrumindia.com/news/97/9560/indias-fast-ageing-population-is-prone-to-alzheimers.html https://biospectrumindia.com/news/97/9560/indias-fast-ageing-population-is-prone-to-alzheimers.html Wed, 20 Sep 2017 17:05:00 +0530 According to the India Ageing Report 2017, the elderly population in India is growing at 3 per cent annually, a faster rate of growth than other age categories. This shift in population age structure means that the burden of Alzheimer’s in India is set to increase given that the disease primarily occurs in patients over the age of 65 years. “Alzheimer’s carries with it significant economic and social costs. As our country and the global population ages, the burden of Alzheimer’s disease will continue to increase and put additional pressures on the limited resources available to tackle the situation. Women are expected to bear the worst of the impact in India, as elderly women in the country experience higher life expectancies than their male counterparts, while also encountering neglect as they age. A 2016 Lancet study on healthy life expectancy revealed that while women in India have a higher overall life expectancy than men, women also spend more years in ill health and disability than men,” said Dr Chirag Trivedi, President of ISCR. “We need to intensify clinical research efforts to look for a cure for Alzheimer’s.” There has been no US FDA approved drug for Alzheimer’s since 2003 and although there are several trials currently underway, a cure is still many years away. Every year, September 21 is marked around the globe as World Alzheimer’s Day. Alzheimer’s disease is a progressive, neurodegenerative disease that affects cognitive functioning, and in its worst forms, can severely interfere with day-to-day living. It is the most common form of dementia in the elderly and accounts for 60 to 80 percent of dementia cases. There is no cure for Alzheimer’s and currently available therapies cannot stop memory loss, however, getting treatment in time can slow down the progression of the disease. Alzheimer’s is not a normal part of ageing, therefore, it is important to be aware of the warning signs and initiate treatment at the earliest possible as the condition keeps deteriorating with time. Census data indicates that about 71 per cent of India’s elderly reside in rural regions, with the exceptions of Goa and Mizoram. States ranking lower on the economic ladder, such as Odisha, Bihar and Uttar Pradesh have a larger percentage of the rural elderly. These areas are hard to reach, with poor road and logistical access. As a result, the ageing population in these areas lack sufficient access to quality care. “Most of our elderly live in areas which are hard to reach, making access to care and monitoring extremely complicated. We also lack specific and detailed data pertaining to these populations, which would otherwise help us devise ways to care for them and make their daily lives and the lives of their family members easier. Research logically emerges as the only way to confront these challenges we face – the more we know, the more we can do,” added Dr. Trivedi ]]> https://biospectrumindia.com/news/97/9541/mtai-medtech-summit-2017-demystifying-the-medtech-sector.html https://biospectrumindia.com/news/97/9541/mtai-medtech-summit-2017-demystifying-the-medtech-sector.html Fri, 15 Sep 2017 18:35:00 +0530 The Medical Technology Association of India (MTaI) held its maiden MedTech Summit today in New Delhi. The first-of-its kind Summit brought together the unique and much needed interface of policy makers, Industry, doctors with the patients. Key departments and ministries such as the Ministry of Commerce and Industry, Department of Health and Family Welfare, and the NITI Aayog were represented at the Summit. The medical technology industry was represented by top MedTech companies including inter alia Abbott Vascular, Alcon, Bard, Bausch & Lomb, Boston Scientific, Johnson & Johnson, KARL STORZ, Medtronic, Olympus, Terumo, and Vygon India.  The MedTech Summit put forward some key asks and recommendations for the consideration of the policy makers that would pave the way for a more enabling environment for the industry. Pavan Choudary, Director General said, “The healthcare sector rests on four pillars – Hospitals, Pharmaceutical industry, Health Insurance industry and the MedTech industry. The last of these is the least understood of all yet most significant for enhancing quality of healthcare, and has direct implications for patient outcomes. This implores the need for more nuanced approaches in policymaking for the sector. The sector needs to be uncovered and it is the patient who should do the unveiling, which is what the aim of this Summit is.”  In view of recent policy changes in the medical technology space, the industry stressed on the need for the sub-sectoring and sub-categorization of medical devices on the basis of the engineering complexity, for policy and decision clarity.   Import substitution as a focus of policies needs to be replaced with greater efforts directed towards ensuring global competitiveness through export promotion and meeting global quality standards. The recently presented NITI Aayog action agenda recognizes the significance of global companies’ presence for the domestic industry to compete with and grow.  Make in India, a noble initiative, should however be implemented in a phased manner. It must focus on the devices that have the potential to be made locally in the short run, instead of the advanced technologies that require a more enhanced ecosystem and know-how that may take years to develop in the country.  This means that policies must factor in the existing gaps in the domestic manufacturing industry, and promote ease of doing business by way of reduced inter-organizational delays, enhanced startup industrial finance, simplified regulations such as single-window clearance, and greater investment in infrastructure. Another key recommendation put forth at the Summit was to expand the bed capacity in the country. This is particularly crucial given the rising burden of diseases in the country today and the lack of access to quality healthcare. Many pockets of the country remain underserved, and are calling out for real-time scaling up of solutions to address this demand. The expansion of the healthcare delivery system will automatically provide an impetus for the medical devices market to grow.  Further, for long term advantage, infrastructural development and fiscal incentives are needed to keep the wheels of innovation and R&D rolling. This will simultaneously help achieve the twin objectives of greater patient access as well as the availability of latest and high-quality technology.  Dr. Shekhar Agarwal, Chief Surgeon, Delhi Institute of Trauma & Orthopaedics, Sant Parmanand Hospital said, “A patient may compromise on the surgeon’s fee and the quality of hospital room, but seldom on the quality of the medical device. Multinational companies have made significant training and capacity building efforts among healthcare workers in the country in the last few decades. Detracting from the progress made in the MedTech space will only set us back by decades.” Urvashi Prasad, Public Policy Specialist, Office of Vice Chairman, NITI Aayog said, “There is a need to look at medical devices holistically, and not through narrow prisms of singular initiatives and policies.” Dr. Dinesh Jain, Vice President – Clinical Data Analytics, Max Hospital said, “It is imperative for hospitals to be transparent in order for the healthcare sector to be more outcome-oriented.” Diwaker Rana, Chairman, MTaI MedTech Summit, “At the Summit today, the patients’ perspective reaffirmed how important medical technology and the quality of medical device are for transforming lives, and the physicians’ perspective reiterated the importance of training in the adoption of medical technology for better outcomes.”    ]]> https://biospectrumindia.com/news/97/9539/researchers-create-microdevice-to-track-pills-in-body.html https://biospectrumindia.com/news/97/9539/researchers-create-microdevice-to-track-pills-in-body.html Fri, 15 Sep 2017 17:25:00 +0530 Researchers at the California Institute of Technology (Caltech) in the US have developed the prototype of a miniature device that can be inserted and tracked in smart pills to diagnose and treat diseases. Based on magnetic resonance imaging (MRI) principles, the new addressable transmitters operated as magnetic spins (ATOMS) are silicon chip devices that allow accurate identification within the body. Integrated with sensors, resonators and wireless transmission technology that simulate magnetic resonance properties of atoms, the microdevices can be located using magnetic fields. The devices are intended to monitor the gastrointestinal tract, blood or brain through the measurement of various factors such as pH, temperature, pressure and sugar concentrations that are relayed to doctors. It is expected that the devices can also be instructed to release drugs within the body. ]]> https://biospectrumindia.com/news/97/9512/cytecare-conducts-workshop-on-clinical-research-writing.html https://biospectrumindia.com/news/97/9512/cytecare-conducts-workshop-on-clinical-research-writing.html Fri, 08 Sep 2017 17:50:00 +0530 To give impetus to young cancer researchers, Cytecare Cancer Hospitals in association with Australia & Asia Pacific Clinical Oncology Research Development  (ACORD) hosted a workshop on ‘Clinical Research Writing’ at Cytecare Cancer Hospital. The objective of this one day workshop hosted is to help early career researchers turn their ideas for clinical cancer research into persuasive 1-page concept outlines. Concept outlines are an ideal starting point for writing study protocols, letters of intent to industry or grant applications to funding bodies. Speaking about the workshop Dr. Vikram Kekatpure Senior Consultant Head & Neck Surgical Oncology said, "Future therapy and progress in oncology will depend on quality clinical research. Cytecare has partnered with ACORD which facilitates clinical research and development in Asia Pacific, the workshop intent to develop young and future oncologist as clinician scientist for betterment oncology care in our country". The workshop had sessions by seasoned oncologists like Dr. Hari Menon & Dr. Prasad Narayanan of Cytecare Cancer Hospitals and  Dr. Andrew Martin from NHMRC Clinical Trials Center, University of Sydney, Australia & Dr. Gary Clark from  Colorado, USA.  Participants were notified to be prepared with an idea for a clinical research study which was discussed during the course of the workshop, faculty members helped participants leave with a persuasive one-page concept outline. The workshop program included short presentations, written exercises and group discussion. The participants were encouraged to submit their completed concept outlines as part of an application to attend the next 7-day ACORD Protocol Development Workshop scheduled for September 2018, in Queensland, Australia. ]]> https://biospectrumindia.com/news/97/9502/myriad-launches-hereditary-cancer-detection-tool.html https://biospectrumindia.com/news/97/9502/myriad-launches-hereditary-cancer-detection-tool.html Thu, 07 Sep 2017 11:50:00 +0530 US-based molecular diagnostics firm Myriad Genetics has introduced a new medical tool, riskScore, to support its myRisk test developed for hereditary cancer. riskScore is an algorithm designed to combine genetic markers with a patient’s family and clinical history to quantify the risk of breast cancer development. The tool will combine data from more than 80 genetic markers called single nucleotide polymorphisms (SNPs) throughout the genome with a family and personal history algorithm called Tyrer-Cuzick model. The Myriad myRisk Hereditary Cancer test is a 28-gene panel that can identify the risk of breast, ovarian, gastric, colorectal, pancreatic, melanoma, prostate and endometrial cancers. In addition to a risk assessment, the simple and easy-to-use test delivers specific medical management recommendations to patients who test either positive or negative according to the guidelines of select professional medical societies. ]]> https://biospectrumindia.com/news/97/9464/perkinelmer-conducts-seminar-on-medical-genomics.html https://biospectrumindia.com/news/97/9464/perkinelmer-conducts-seminar-on-medical-genomics.html Thu, 31 Aug 2017 13:00:00 +0530 PerkinElmer Health Sciences Pvt Ltd (PEHS), a screening and diagnostic laboratory of PerkinElmer, Inc. has  kicked off a series of seminars for neurologists, paediatricians and gynaecologists in Delhi, Mumbai, Hyderabad, Chennai and Mangalore, India. These events serve as an ideal platform for discussing PerkinElmer’s recently launched affordable gene panels, whole exome sequencing (WES) and whole genome sequencing (WGS) services using next generation sequencing and other complementary assays to address the broad range of genetic disorders. At the first conference, which took place in Delhi, Dr. Madhuri Hegde, Vice President and Chief Scientific Officer, PerkinElmer Diagnostic Laboratory Services, delivered a talk, ‘Simplifying Genomics: Transforming Complexity into  Meaning’  to a group of  clinicians.  Starting her presentation, Dr. Hegde said, “A growing interest in personalized medicine calls for genome sequencing in clinical diagnostics, but major challenges must be addressed before its full potential can be realized. This talk on a medical genetic testing algorithm will help clinicians select the most appropriate molecular diagnostic tool for each scenario.”  Dr. Hegde also serves on the board of ACMG Foundation for Genetics and Genomic Medicine and is an Adjunct Professor of Genetics and Paediatrics at Emory University and Georgia Institute of Technology. Dr. IC Verma, a pioneer in field of Genetic Medicine joined the session in Delhi and commented: “This is a most exciting time in genetics. As a result of the new genomic sequencing technologies we can arrive at a diagnosis in many more patients than before. Finding the variation in genes is leading to development of new treatments for the genetic disorders. The medical professionals must take advantage of the genomic tests being offered in India at an affordable rate. The genetic tests enable screening of couples for being carriers of genetic disorders, genetic counseling and prenatal diagnosis to prevent disease and the possibility of new treatments.” Dr. Verma is a renowned medical geneticist. He received genetics training in the UK, USA & Switzerland. He is a Fellow of the Royal College of Physicians, London, the American Academy of Pediatrics, and the National Academy of Medical Sciences, New Delhi. He has received a number of national awards - Ranbaxy Science Award, ICMR, NAMS and BC Roy Medical Council award. He is a Member and Vice-chairman of the Ethics Committee of the International Human Genome Organization (HUGO) and serves as an adviser in genetics to the WHO in Geneva, and to Roche Genetics in Basel. “The launch of our genetics service is all about providing quality and specialised service to clinicians in India.  Dr. Hegde brings our customers high confidence in PerkinElmer’s quality sample analysis and reporting,” said Jayashree Thacker, President, PerkinElmer India.  “We have been observing a high demand of sequencing services for rare inherited disease. Combining these offerings with our current portfolio will help address the evolving needs of our customers.” PerkinElmer now offers its customers a global genomic lab testing platform that performs screening and diagnostic testing, specializing in newborn screening and high throughput next generation sequencing for rare inherited diseases ]]> https://biospectrumindia.com/news/97/9454/hairline-international-launches-hair-dna-testing.html https://biospectrumindia.com/news/97/9454/hairline-international-launches-hair-dna-testing.html Tue, 29 Aug 2017 18:05:00 +0530 Our hair can tell us a lot about our bodies and our predisposition to ailments. With a focus on offering assessment as well as customized treatment options for hair fall, hair loss and predictive capabilities as well, Hairline International Hair and Skin Clinic launches Hair DNA testing which takes an in-depth look at genetic markers for hair loss, assesses a predisposition to the development of hypertension and cardiovascular conditions, and aids in the creation of tailor-made treatment and diet plans. In this simple cheek swab test, genetic markers for hair follicular stress, inflammation and growth factors are analysed. Speaking on the launch of Hair DNA testing, Dr. Bani Anand, Founder and Managing Director, Hairline International Hair and Skin Clinic says, “At Hairline International, we have always worked towards holistic approaches to hair and skin ailments. Hair DNA testing, besides being complementary to the Skin DNA testing we offer, helps determine one’s propensity for lifestyle based ailments and this can go a long way in helping a patient make the right changes”. Explaining in detail on the working of Hair DNA testing at Hairline, Dr. Premalatha V, Dermatosurgeon, Hairline International Hair and Skin Clinic said, “At Hairline, we offer 5 different Hair DNA Testing panels. Each of these panels has a specific outcome that works towards assessing: Genetic tendencies towards balding As Predictor of baldness Customization of treatment for hair fall Drug responsiveness to commonly used medication like Finasteride and Minoxidil Health markers to determine tendency towards cardiovascular ailments, hypertension, obesity and diabetes. This panel is a part of Nutrigenomics – a science that can help customize and alter lifestyle and nutrition patterns based on an individual’s genetic make-up”. Explaining Nutrigenomics, Ms Mansi Belani, Fitness Nutritionist, Hairline International Hair and Skin Clinic says, “Nutrigenetic test is a genetic analysis that aims to understand an individual’s genetic makeup can influence the way his body responds to food and the nutrients he gets from it. It looks into how these genetic differences can affect health. Nutrigenomics goes down to the DNA level of individual to better understand what nutrition the body specifically needs and what may be lacking. It also predicts what metabolic diseases and allergies one may prone to. The in-depth research that is being conducted in the field will now make way for gene-specific diets, ensuring that your diet too can be DNA-based”. Elaborating on the benefits of Hair DNA testing, Dr Premalatha further explains that the test helps an individual in two primary ways Customization of treatment for hairfall Nutrition based treatment that is specific to an individual “Hair DNA panels are ideal for those looking to take preventive care, especially if they find they are predisposed to hair loss, hair fall and even cardiovascular diseases and hypertension. Besides that, two of the most important drugs used in the treatment of hair loss are Minoxidil and Finasteride, both of which are FDA approved. There are however possibilities of patients being resistant to the drugs and this test helps determine that, allowing for the medical professional to utilize adjuvant therapies rather than have unnecessary exposure to these medicines” adds Dr Premalatha. ]]> https://biospectrumindia.com/news/97/9440/cipla-launches-nicotex-nicotine-patch.html https://biospectrumindia.com/news/97/9440/cipla-launches-nicotex-nicotine-patch.html Thu, 24 Aug 2017 16:15:00 +0530 Cipla Health Limited, a leading healthcare company has announced the launch of Nicotex Nicotine Patches. Nicotex Nicotine Patch is a skin / transdermal patch that works on the proven principle of Nicotine Replacement Therapy (NRT) and helps you quit smoking in 12 weeks.  “Our goal, at Cipla Health has always been to provide highly innovative healthcare solutions that truly improve the lives of our consumers. Through Nicotex, we have helped thousands of people to quit smoking and with the launch of Nicotex Patch, a new and innovative solution for smokers, we plan to expand this consumer base further, said Anantha Nayak, Chief Executive Officer, Cipla Health Limited. Over 900,000 people in India die every year due to tobacco related diseases. One of the key challenge in this regard is the difficulty associated with quitting smoking. As per the recent Choose Life study, 40% smokers have made more than 4 attempts and 90% smokers have made more than 2 attempts to quit smoking and yet failed.  “Nicotex is the No. 1 doctor recommended brand in India and with Nicotex Patch, I believe we will only strengthen our association with doctors going ahead”, Anantha further added. One of the most important features of Nicotex Patch is that the user needs to apply only one patch a day without having to worry about it for the rest of the day. Through its 24 hour smart release system, Nicotex Patch releases a measured dose of nicotine throughout the day, thereby reducing the urge to smoke and in turn help people give up the habit of smoking. Nicotex Patch comes in 3 strengths; 21 mg, 14 mg and 7 mg. For those smoking more than 20 cigarettes, they need to start with the 21mg patch. For those smoking less than 20 cigarettes, they need to start with 14mg patch. The patch uses a step-down dosing therapy approach that will help smokers to keep their cravings and withdrawal symptoms in check. The product will be available with leading chemists and key ecommerce partners across all major cities in India.   ]]> https://biospectrumindia.com/news/97/9439/siemens-receives-ce-mark-for-magnetic-resonance-scanner.html https://biospectrumindia.com/news/97/9439/siemens-receives-ce-mark-for-magnetic-resonance-scanner.html Thu, 24 Aug 2017 11:55:00 +0530 Siemens Healthineers has received CE-Mark for its ultra-high-field 7T magnetic resonance (MR) scanner Magnetom Terra, making it available for neurological and musculoskeletal clinical examinations in Europe. In addition to detailed insights of the musculoskeletal system, Magnetom Terra’s high spatial and spectral resolution enables imaging of metabolic processes in the brain, as well as visualisation of neurological diseases such as Alzheimer's, epilepsy, and multiple sclerosis (MS). It is expected that the high-resolution of the scanner will provide clear pictures of brain lesions, including better white and gray matter differentiation in epilepsy and improved visibility in gray matter in multiple sclerosis. Use of the new MR scanner will enable anatomical imaging of small pathologies and sub-cortical brain activation, while it will also aid the assessment of anatomy, function and metabolism of body tissue. The scanner uses an actively shielded whole-body magnet that is manufactured at Siemens Magnet Technology in Oxford, UK, and is 50 per cent lighter than previous magnets. ]]> https://biospectrumindia.com/news/97/9419/immatics-initiates-its-cellular-therapy-for-cancer-patients.html https://biospectrumindia.com/news/97/9419/immatics-initiates-its-cellular-therapy-for-cancer-patients.html Mon, 21 Aug 2017 13:45:00 +0530 Immatics, a leading company in the field of cancer immunotherapy, announced that it has initiated enrolment of patients into a phase I trial of its first adoptive cellular therapy (ACT) IMA101, using its proprietary ACTolog approach. The IMA101 phase I trial is the first industry-sponsored trial using products consisting of autologous cytotoxic T lymphocytes targeting defined tumor antigens using Immatics’ novel and proprietary target warehouse. This single-center study is now open for enrollment at The University of Texas MD Anderson Cancer Center in Houston, Texas. IMA101 is a personalized, multi-targeted investigational immunotherapy for the treatment of multiple solid tumors, including but not limited to ovarian cancer, gastric cancer, esophageal cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer. This study will include up to 20 patients with relapsed and/or refractory solid cancers, for which no established treatment is available. The ACTolog approach is based on the principle of expanding specific endogenous T-cells, a therapy pioneered by Cassian Yee, M.D., Professor at MD Anderson. ACTolog combines several innovative features: The target antigens have been validated as being naturally presented in various solid tumors by Immatics’ proprietary XPRESIDENT target discovery platform. The ACTolog approach generates multiple cell therapy products, each directed against a different tumor target. This approach is designed to be effective in the event of tumor escape variants, compared to targeting just one single antigen. The selection and manufacture of each patient’s ACTolog cell therapy product is actively tailored by measuring the relative presence of eight pre-selected and well-characterized patient tumor-specific antigens. The primary objective of the IMA101 study is to evaluate the safety and tolerability of the ACTolog approach in patients with target-positive solid cancers. Secondary objectives are the evaluation of feasibility, the persistence of T-cells in vivo, and assessment of anti-tumor activity and biomarkers. Apostolia Tsimberidou, M.D., Ph.D., Professor at the Department of Investigational Cancer Therapeutics at MD Anderson is the Principal Investigator for the IMA101 phase I trial. Dr. Harpreet Singh, Immatics’ Chief Scientific Officer and CEO of Immatics US, commented: “Entering clinical development with our first adoptive cell therapy program is a significant step for Immatics, and highlights the ability of the XPRESIDENT platform to identify novel and true tumor antigens directly from a patient’s tumor. We are very excited to be combining our unique target discovery capabilities with the world-leading expertise of key investigators from the MD Anderson Cancer Center. We believe that attacking multiple cancer targets simultaneously using our tailored approach may lead to promising new treatment options for cancer patients with significant unmet medical need.” ]]> https://biospectrumindia.com/news/97/9392/ins-india-launches-new-online-courses-on-infusion-therapy-for-nurses.html https://biospectrumindia.com/news/97/9392/ins-india-launches-new-online-courses-on-infusion-therapy-for-nurses.html Wed, 16 Aug 2017 15:45:00 +0530 On its 6th National conference, Infusion Nurses Society (INS), India is all set to launch one of its own kind online courses on Infusion therapy for nurses. Utilizing the reach and ease of digital platform, the course will enable INS members to access the various infusion therapy modules and speaker presentations from previous conferences through INS website http://www.insindia.org.  The first course would be on the Peripheral IV Cannulation. “Infusion Therapy is a comprehensive method of quality care to all patients. Online courses will educate the nurses in the scientific method of delivering and maintaining infusion with the aim of cure and prevention of Infection,” says Clare D’Mello, Assistant Nursing Superintendent, Saifee Hospital. Nine out of ten patients admitted in hospitals receive infusion therapy during the course of their stay for therapeutic or diagnostic purposes. Improper infusion practices may lead to complications, causing an increase in mortality, morbidity, duration of hospital stay and healthcare costs. In a complex healthcare environment, with varied patient needs, ensuring the quality of infusion calls for best nursing practices, explains Havovi Fouzdar, GM-Nursing, KDA Hospital, “To ensure a patient-centered plan of care, a nurse strives to meet the infusion needs of their patients. In doing so, they need to strictly adhere to the best practices and the comprehensive INS standards help the infusion nurses to provide excellent infusion care across all practice settings.” Along with online infusion therapy courses for the nurses, INS India is now launching an online course for its 3000 members on peripheral IV cannulation and an annual Mastermind Quiz, where all region’s hospitals will compete for the rotating trophy. The MasterMind Quiz is in collaboration with BD India. The qualifying round was online on INS website open to all registered nurses across the country. The top scorers will represent their region and hospital for the final round on Day 1 of the conference. “The thinking behind such initiatives is to engage healthcare professionals to intensify the best safety and quality practices in infusion management across the country. INS India is grateful to partners like BD-India and 3M in this drive that are helping us to ensure sustained efforts towards ensuring best infusion practices and will go a long way to deliver quality patient care in India,” says Col Binu Sharma, President, INS India. In the past, INS India launched an android app for the nurses and standards to help healthcare professionals, institute gold standard and evidence based protocols into patient care practices, by minimizing medication errors, treatment related complications and healthcare associated infections. The revised standards will be instrumental in ensuring safety for patients and healthcare professionals. With such online courses and Android apps, INS India wants to empower nurses with digital tools in infusion standards for better patient care. ]]> https://biospectrumindia.com/news/97/9384/clarius-launches-wireless-ultrasound-scanners.html https://biospectrumindia.com/news/97/9384/clarius-launches-wireless-ultrasound-scanners.html Mon, 14 Aug 2017 12:10:00 +0530 Canada-based healthcare technology firm Clarius Mobile Health has launched the latest Clarius App 3.1 Eclipse wireless handheld ultrasound scanner with advanced features and options. Available on the App Store and Google Play, Clarius Ultrasound Scanners are developed as a visual stethoscope for clinicians and allow quick scans, as well as guide short procedures. The Clarius C3 multipurpose ultrasound scanner can be used to image abdomen and lungs, and additionally includes a virtual phased array for quick scan of the heart, while the Clarius L7 is designed to guide procedures and image superficial structures. The new Clarius Eclipse comes with increased capabilities for annotations to automatically monitor heart rate during cardiac scanning and for easy measurement of bladder volume. Clarius Scanners are built with a magnesium case to withstand challenging environments and are made water submersible to allow easy cleaning and disinfection. ]]> https://biospectrumindia.com/news/97/9379/cytecare-introduces-3-d-imaging-technology-for-breast-cancer-screening.html https://biospectrumindia.com/news/97/9379/cytecare-introduces-3-d-imaging-technology-for-breast-cancer-screening.html Fri, 11 Aug 2017 11:30:00 +0530 Breast Cancer has been ranked as the number one cancer among Indian women with age adjusted rate as high as 25.8 per 100,000 women, as per the latest statistics published in the Asia Pacific Journal of Clinical Oncology. Bengaluru has ranked third with age adjusted incidence rate of carcinoma of the breast found as high as 34.4 per 100,000 women. Projections for India suggest the number of breast cancer cases will likely go as high as 1,797,900 by 2020. Though there has been an increase in health check-ups among women recently, we can still see that screening is low on priority even in major cities. Cytecare hospital is the first hospital in the city to introduce Digital Breast Tomosynthesis (popularly known as 3D-Mammography) for women. Mammography continues to be the only screening test proven to decrease mortality from breast cancer. However, 2D mammography is less accurate in women with dense breasts for whom cancer may be masked by overlapping breast tissue. When a 2D mammogram detects an area of concern, radiologists further investigate with a diagnostic mammogram, ultrasound or biopsy. Looking at the same breast tissue in 3D, the radiologist may now be able to see that the abnormality on 2D mammogram in fact represents normal breast tissue. This avoids further investigation in large number of patients undergoing routine screening. 3D mammography or Tomosynthesis is a special kind of mammogram that uses several low dose x-rays obtained at different angles to create multiple images or “sequential slices” that step through the breast tissue and allows radiologists to see more clearly. The breast is positioned and compressed in the same way as for a 2D mammogram but the x-ray tube moves in a circular arc around the breast. It takes less than 10 seconds for the scan. The information from the x-rays is sent to a computer, which produces a focused 3-D digital image of the breast. Talking about Digital Breast Tomosynthesis Dr. Mukta Mahajan, Consultant radiologist, Breast Imaging and Intervention said, "The most important aspect as a Breast Radiologist at Cytecare Hospital is to spread awareness about personal risk-based screening and extent evaluation of breast cancer prior to planning treatment. There is no organised national or regional breast cancer screening program in India. Naturally, majority of those involved in women's health are not aware of the available technology and expertise in the field of breast cancer diagnosis. Needless to say, women undergoing screening have little understanding of the tests or the results thereof. In contrast to the western world, breast cancer incidence is much higher in premenopausal age group (<50 years) in India. As compared to both screen-film and Computed Mammograms (older but most widely used technologies), 2D and 3D Digital Mammography has significantly higher accuracy in cancer detection in younger women and in women with dense glandular breasts. This will have large impact on decreasing the number of women undergoing unnecessary recalls or biopsies. It is most important to avoid anxiety in women opting for screening tests. 3D mammography serves as an excellent problem solving tool and reduces misdiagnoses. Contrary to common practice, ultrasound alone has significant limitations as a screening tool and must always be combined with a 2D or 3D Digital Mammogram. The x-ray dose of 3D mammography is comparable to that of a 2D mammogram. Therefore the cumulative dose of the combined screening is still below the FDA-regulated limit and found to be safe and effective for patient use. I think this technology has greater relevance for Indian women.  Incorporating this aspect Cytecare hospital's breast imaging services are complete with Digital Breast Tomosynthesis (DBT or 3D Mammogram), Full Field Digital Mammogram (FFDM), Stereotactic and Vacuum Assisted Breast Biopsy (VABB). ” 3D mammography has shown to reduce percentage of missed cancers by 15%. More recent studies show about 30% increased 3D mammography sensitivity and specificity compared to 2D Mammography with a recalls reduction in screening by approximately 40%. ]]> https://biospectrumindia.com/news/97/9376/fda-clears-aums-diagnostic-cardiovascular-device.html https://biospectrumindia.com/news/97/9376/fda-clears-aums-diagnostic-cardiovascular-device.html Thu, 10 Aug 2017 17:05:00 +0530 The US Food and Drug Administration (FDA) has cleared AUM Cardiovascular’s acoustic and electrocardiogram (ECG) device called CADence to aid detection of physiological and pathological heart murmurs. CADence is a non-invasive, radiation-free handheld and reusable device designed to record sounds emitted by a patient’s heart. It has been used in a total of 1,807 patients to date. The device employs an algorithm and features specific software that crunches the acoustic data presented in the report to enable a physician to analyse the patient's cardiovascular health. The firm is currently working towards obtaining clearance from the FDA to commercialise CADence for CAD detection, with plans to launch additional algorithms that can crunch the acoustic data to detect stenosis, which is characterised by clogged arteries with plaque. ]]> https://biospectrumindia.com/news/97/9375/b-r-shetty-group-to-set-up-healthcare-centre-in-ap.html https://biospectrumindia.com/news/97/9375/b-r-shetty-group-to-set-up-healthcare-centre-in-ap.html Thu, 10 Aug 2017 16:55:00 +0530 Abu Dhabi-based B R Shetty group will set up a quantum and analytics healthcare centre as a part of the proposed integrated BRS Medicity in Andhra Pradesh's capital city Amaravati. Chief Minister N Chandrababu Naidu laid the foundation stone for the BRS Medicity, a 1.8 billion USD project, in the capital region. The quantum and analytics healthcare centre is being set up with an investment of Rs 330 crore. It will consist of a research centre, quantum computing secure hardware zone and data centre, according to a release issued by the AP Capital Region Development Authority. The Medicity will have a Rs 1,150 crore medical university for 800 students, Rs 1,500 crore super-speciality hospital with 1,500 beds, Rs 500 crore medical devices manufacturing facility, knowledge process outsourcing centre that will employ 4,000 people, stem cell research centre, naturopathy and a yoga centre. The BR Shetty group will also set up an International Baccalaureate School that could have could have an intake of 2,890 students and provide 500 jobs. ]]> https://biospectrumindia.com/news/97/9355/hairline-international-launches-robotic-hair-transplant-system.html https://biospectrumindia.com/news/97/9355/hairline-international-launches-robotic-hair-transplant-system.html Fri, 04 Aug 2017 12:05:00 +0530 Hairline International Hair and Skin Clinic has launched a novel means of  Hair Transplant at their clinic. Known as the Human Assisted Rapid Robotic Hair Transplant (HARRTS),  now a Robot will maximize hair transplant results manifold when compared to conventional methods of FUT, FUE and the combination technique. It also reduces the time frame in which a transplant takes place. Explaining the functioning of the Robotic Hair Transplant system, Dr. Dinesh G Gowda, Dermatosurgeon, Hairline International Hair and Skin Clinic says, “While the dermatosurgeon is the one who inputs required fields in terms of depth for extraction and implantation, number of follicles to be extracted as well as the area of implantation, it is the robot that accurately carries out the entire procedure". “The Robot consists of a hand piece that is uniquely designed for speed, safety and accuracy. Placed close to the hand piece is the Cold Bio-Fluid Storage canister which ensures that the grafts have good survival rate in the cold storage safety punch. Each of the punches are uniquely designed for accurate depth control and the silicone covering over the step prevents rotational skin abrasion that is common. The implanter is the first of its kind in the world that implants grafts with and without a slit creation thereby avoiding any unnecessary incisions into the skin, oozing or the flooding of grafts, pop outs etc ensuring that the implantation time is reduced by half when compared to other methods of transplant”, adds Dr. Gowda. Speaking on introducing Robotic Hair Transplant at Hairline International, Dr. Bani Anand, Founder and Managing Director, Hairline International Hair and Skin Clinic says, “We have seen that patients want procedures that are quick, minimally painful and non invasive which yield the best results. Robotic Hair Transplant ensures high levels of accuracy and results. In fact, considering the reduced number of personnel required to complete the procedure, the patient is much more at ease as well. The system also comes with an integrated cloud data management system which makes programing of depth for extraction and implantation easy and accurate”. Robotic Hair Transplant ensures that the infection rate and bleeding is minimal as the procedure is extremely accurate in terms of depth and breadth of extraction or implantation of the hair. In fact, depth control can be pre-fixed using a calibrated computerized approach. The procedure ensures that there is minimal exposure of hair follicles to an external environment reducing dessication and depth the follicles and thus enhancing the results of a hair transplant. ]]> https://biospectrumindia.com/news/97/9279/an-innovative-newborn-hearing-screening-device-launched-by-the-government-.html https://biospectrumindia.com/news/97/9279/an-innovative-newborn-hearing-screening-device-launched-by-the-government-.html Wed, 19 Jul 2017 11:55:00 +0530 The indigenously developed newborn hearing screening device “SOHUM” has been launched by the Y.S. Chowdary, Minister of State for Science and Technology & Earth Sciences in New Delhi recently. SOHUM has been developed by startup Sohum Innovation Labs India Pvt. Ltd. under Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India supported (SIB). SIB is a flagship program of the DBT aimed to develop innovative and affordable medical devices as per unmet clinical needs of India and to train the next generation of medical technology innovators in India, it is a valuable contribution to the Make in India campaign of the Government. This Program is implemented jointly at AIIMS and IIT Delhi in collaboration with International partners. Biotech Consortium India Limited manages techno-legal activities of the Program.  This low cost and unique device uses brainstem auditory evoked response which is the gold standard in auditory testing to check for hearing response in a newborn. As of now, this technology is prohibitively expensive and inaccessible to many. It aims to cater to nearly 26 million babies born every year in India.  SOHUM measures auditory brain waves via three electrodes placed on the baby’s head. When stimulated, they detect electrical responses generated by the brain’s auditory system. If there is no response, the child cannot hear. The battery-operated device is non-invasive, which means babies do not need to be sedated, which is the current, and risky, testing in process at present. Another key advantage over other testing systems is the patented, in-built algorithm that filters out ambient noise from the test signal. This is important because health clinics can be incredibly crowded and noisy. Currently, five clinical centers are running the hearing screening program as the device has been installed in all five of them. The aim is to screen two percent of hospital-born babies in the first year, before scaling up. The project has ambitious plans to help every baby born in India be screened.  ]]> https://biospectrumindia.com/news/97/9277/indias-first-robotic-kidney-cancer-surgery-successfully-conducted-by-saifee-hospital.html https://biospectrumindia.com/news/97/9277/indias-first-robotic-kidney-cancer-surgery-successfully-conducted-by-saifee-hospital.html Wed, 19 Jul 2017 11:30:00 +0530 Saifee Hospital has successfully conducted a robotic kidney cancer surgery on a patient who had previously undergone a kidney transplant.  Robotic surgery ensures minimum blood loss, minimum pain and minimum hospital stay (three days), which were the factors played a role in preventing infection, in this immunocompromised patient. This robotically assisted system allows the surgeon a three-dimensional view of organs such as kidney and prostate by magnifying the image to twelve times the size visible to the naked eye. Furthermore, due to 360-degree movement of robotic arms, robotic surgery is the most precise, minimally invasive and necessary approach for a critical surgery of this kind. This is the standard procedure that is followed worldwide, in the case of such uro-oncological conditions.  Dr Anup Ramani Uro-Oncological Robotic Surgeon, Director of Minimally Invasive Surgery at Saifee Hospital said, “Over the last 10 years, robotic surgery has grown to become the pinnacle of precision for surgical treatments related to kidney cancer or prostate cancer across the world. Open surgery has phased out because robotic surgery significantly reduces blood loss, pain and invasiveness as compared to open surgery. This ensures faster recovery and better long term results. Since, the patient had a rare uro-oncological condition, in which the transplanted kidney was in close proximity to the cancerous kidney, the robotically assisted surgery allowed me to remove the cancerous kidney with as much precision. There was no blood loss and the patient was discharged within three days of surgery.”  Dr. Hemal Shah, Head of Department of Nephrology and Consultant at Saifee Hospital said, “Over five years ago, the patient had undergone a kidney transplant surgery. In early June this year, after the patient reported an abdominal pain, a CT scan was advised by the doctor. The reports revealed a cancerous tumour in the patient’s failed kidneys. In order to treat this condition, we needed to ensure a complete removal of the cancer with minimum chances of infection. Due to its well-equipped infrastructure, the Saifee Hospital was able to perform the surgery in a precise, efficient and affordable manner.”  ]]> https://biospectrumindia.com/news/97/9266/credihealth-develops-new-system-for-organ-transplants.html https://biospectrumindia.com/news/97/9266/credihealth-develops-new-system-for-organ-transplants.html Mon, 17 Jul 2017 16:15:00 +0530 Aiming to ease the process of finding the right organ donors in India, a medical assistance start-up has developed an algorithm-based system to facilitate donor exchanges for organ transplants. The Gurugram-based company Credihealth assists patients looking for organ swapping services to connect with the right doctor and hospital, and facilitate the exchange of relevant information pertaining to the procedure and cost. In India, there are three different systems for living organ donation. In "living near-related donors" category, only immediate blood relations are usually accepted as donors. The second category is that of "living non-near relative donors" while “Swap donors" constitute the third category. In the third case, where the living near-relative donor is incompatible with the recipient, provision for swapping of donors between two such pairs exists, when the donor of the first pair matches with the second recipient and donor of second pair matches with the first recipient. To facilitate organ swap services, Credihealth would collate a list of legal donor-recipient pairs across hospitals that do not have matching blood groups and connect eligible pairs for transplants based on an algorithm. These donor-recipient pairs will be directed to the hospital of their choice and the hospital will carry out the necessary due diligence for the transplant procedure. ]]> https://biospectrumindia.com/news/97/9262/bio-agile-wins-award-for-clinical-research.html https://biospectrumindia.com/news/97/9262/bio-agile-wins-award-for-clinical-research.html Mon, 17 Jul 2017 13:20:00 +0530 Bio Agile Therapeutics Pvt. Ltd was honoured as the Emerging Clinical Research Organisation of the year 2017 hosted by “Times Television Network - Times Influence National Marketing Excellence Awards (For Excellence in Healthcare)”. Managing Director Ms. Divya Chandradhar received the award held in The Taj Lands’ End, Mumbai on 7th July 2017. The award demonstrates company’s commitment and expertise in providing better clinical research services in India. Bio Agile Therapeutics caters research services to Pharmaceuticals, Nutraceuticals, Herbs, Cosmetics, and Medical Devices industries. The company has been structured to provide quality services to its sponsors. Bio Agile Therapeutics Pvt. Ltd. is a ISO 9001:2015 Certified Company, a privately-owned well established full-service CRO (Contract Research Organization) headquartered in Bangalore, India. It provides end-to-end clinical trial support for Phase II-IV clinical trials. ]]> https://biospectrumindia.com/news/97/9204/seimens-expands-diagnostics-facility-in-us.html https://biospectrumindia.com/news/97/9204/seimens-expands-diagnostics-facility-in-us.html Wed, 05 Jul 2017 17:05:00 +0530 Siemens’ medical technology division Siemens Healthineers has started work on a new $300 million manufacturing and research and development (R&D) facility for laboratory diagnostics at Walpole, Massachusetts, in the US. Expected to create approximately 700 new jobs over the coming ten years, the new facility is intended to enhance customer experience by strengthening healthcare operations. The firm is currently reported to provide more than ten billion laboratory diagnostic tests every year and plans to further bolster its footprint. The company invests more than $1billion annually for R&D in the US and the latest investment is anticipated to expand its capabilities to provide simple solutions for lab professionals, enabling them to spend less time on operations and contribute to better outcomes. Siemens Healthineers develops products and services across diagnostic, therapeutic imaging, laboratory diagnostics and molecular medicine segments. The firm currently operates more than 60 manufacturing sites in the US. ]]> https://biospectrumindia.com/news/97/9128/new-hematology-devices-launched-by-abbott.html https://biospectrumindia.com/news/97/9128/new-hematology-devices-launched-by-abbott.html Tue, 20 Jun 2017 17:35:00 +0530 Abbott has launched two new haematology instruments, Sekisui CP3000 coagulation system and Alinity hq analyser, to aid high-volume laboratories in addressing productivity needs. Designed to test bleeding and clotting function, the Sekisui CP3000 coagulation system is a fully automated analyser that requires small sample volumes and features broad assay menu with rapid result turnaround time. The system allows automated, standardised sample management and identifies unsuitable samples at the beginning of the test. It is compatible with the firm’s informatics solutions suite that aid in enhancing the efficiency of high test volume laboratories and also with Accelerator a3600 automation track developed to offer additional flexibility to the laboratories. The Sekisui CP3000 coagulation system is available in Europe, the Middle East and Asia-Pacific. The Alinity hq analyser automates the performance of diagnostic haematologic tests that analyse blood composition for various factors such as the identification and quantification of various blood cell types. The analyser is a part of the firm’s Alinity portfolio and is said to report on 29 different parameters within minutes. It combines advanced optical technology with algorithms to handle both normal and pathological samples. ]]> https://biospectrumindia.com/news/97/9104/testing-facilities-being-set-up-in-amtz.html https://biospectrumindia.com/news/97/9104/testing-facilities-being-set-up-in-amtz.html Fri, 16 Jun 2017 17:40:00 +0530 TUV Rheinland India, a global leader in testing, training, inspection, consulting and certification of medical devices, has joined hands with Andhra Pradesh MedTech Zone (AMTZ) to set up testing facilities in the country’s first medical technology manufacturing park on the public private partnership mode. The subsidiary of TUV Rheinland Group, Germany, will invest about Rs 85 crores over a period of four-five years in the recently established medtech park at Visakhapatnam to help it achieve its objective of reducing medical device imports, production cost and partner with industry to deliver quality medical devices to local market, and eventually increase the export of world class medical devices to the international market. The contract was signed by Thomas Fuhrmann, Managing Director of TUV Rheinland India and Dr Jitendar Kumar Sharma, Director and CEO of AMTZ. While agreement signing kick-starts a series of technical works, a formal exchange of this agreement is shortly scheduled at a high-level event. As AMTZ is investing on infrastructure and test equipment, it is evident that TUV Rheinland will have a very special price for the medical device manufacturers within the zone. Also, as these world class test facilities are within the zone, medical device manufacturers can use the labs that are available in next door. TUV Rheinland is the only certification body in India that boasts of an accredited welding institute offering welding courses to the industry in order to enhance the technical skills of its employees. The company has ambitious plans for setting up of laboratories in other parts of India as well in the near future. ]]> https://biospectrumindia.com/news/97/9103/bio-rad-gets-fda-approval-for-syphilis-assay.html https://biospectrumindia.com/news/97/9103/bio-rad-gets-fda-approval-for-syphilis-assay.html Fri, 16 Jun 2017 17:15:00 +0530 Clinical diagnostic products developer Bio-Rad Laboratories has obtained the US Food and Drug Administration (FDA) clearance for its BioPlex 2200 Syphilis Total and RPR assay designed to diagnose syphilis infection. To enable effective monitoring of treatment, the BioPlex 2200 Syphilis features fully automated Treponemal/non-Treponemal dual assay that simultaneously detects Treponema pallidum (T. Pallidum) and reagin antibodies, as well as the level of antibody measured as RPR titer. When compared to existing manual RPR card tests, the automation of examination is claimed to allow labour savings, objective result reporting, and improved workflow to laboratories. The system facilitates quick process or multiplex of several individual tests that are usually processed separately. The multiplex feature of the system aids in conserving patient sample volume and simplifies the workflow. The addition of the BioPlex 2200 Syphilis Total and RPR assay broadens the company’s expanding BioPlex 2200 System infectious disease menu while offering laboratories a simplified approach to syphilis testing. It is adaptable to any testing algorithm used by a laboratory. ]]> https://biospectrumindia.com/news/97/9085/new-launches-in-india-by-zebra-technologies.html https://biospectrumindia.com/news/97/9085/new-launches-in-india-by-zebra-technologies.html Wed, 14 Jun 2017 16:15:00 +0530 Boosting its healthcare portfolio with two new mobile handheld solutions to improve clinical mobility workflows and patient care, US-based Zebra Technologies Corporation, the manufacturer and seller of marking, tracking and computer printing technologies, will soon launch its DS8100-HC series scanners and TC51-HC mobile computer for healthcare professionals in India. The DS8100-HC series scanners and the TC51-HC mobile computer come with the capability to easily capture problematic barcodes found in pharmacies, labs and at the point of care to help improve workflows, productivity and efficiency of healthcare professionals. The devices also ensure better patient safety. The DS8100-HC series imager are available in both corded as well as cordless versions. The device features a purpose-built housing using special plastics that prevent the spread of bacteria and allow for safe wipe-downs with a wide selection of strong disinfectants used in hospitals. The TC51-HC mobile computer is Android-enabled and can perform multiple tasks like calling/texting, receiving calls via PBX, accessing patient records, scanning barcodes and increasing medication administration accuracy. Zebra has also joined hands with GE Healthcare to bring Bluetooth Low Energy wireless asset tracking technology to hospitals. GE Healthcare’s Encompass is a cost-effective real-time location systems solution that helps hospitals manage mobile asset inventory, reduce overall cost of ownership and achieve better capital allocation. ]]> https://biospectrumindia.com/news/97/9019/drug-trial-for-multiple-sclerosis.html https://biospectrumindia.com/news/97/9019/drug-trial-for-multiple-sclerosis.html Tue, 06 Jun 2017 11:10:00 +0530 Clinical trials for a medicine to treat multiple sclerosis has been approved. It is the most common auto immune disorder affecting the central nervous system. Despite stringent regulations recently introduced by the Drug Controller General of India (DCGI) that had halted clinical trials in the country for a while, a new step has been taken in this direction. Postgraduate Institute of Medical Education and Research (PGIMER) in Chandigarh is one of seven such institutes in India which has been selected for the trials to be conducted in 32 countries. Besides the PGIMER, the other centres for clinical trial in India are AIIMS, New Delhi; Amrita Institute of Medical Sciences and Research, Kerala; Max Super Specialty Hospital, New Delhi; Sanjay Gandhi Post Graduate Institute of Medical Science, Lucknow; M S Ramaiah Medical College and Hospital, Bangalore; and Jaslok Hospital and Research Centre, Mumbai. The trial will be conducted among 900 patients worldwide, out of which 120 will be from India. The drug ofatumumab for which the trial will start soon is expected to offer lesser side effects and will be more effective than the existing drug teriflunomide in patients who suffer from relapsing multiple sclerosis. The new drug will be tested for its efficacy and side effects as compared to teriflunomide. It is known that ofatumumab is a chemotherapy medicine approved by the US Food and Drug Administration. The ethical committee has given the approval for the trial to begin and patients would soon be coming in. ]]> https://biospectrumindia.com/news/97/9003/diagnostic-genetic-tests-for-hereditary-cancers.html https://biospectrumindia.com/news/97/9003/diagnostic-genetic-tests-for-hereditary-cancers.html Mon, 05 Jun 2017 14:50:00 +0530 Phosphorus, a genomic health company offering diagnostic genetic tests and clinical software, have released advanced tests for hereditary cancers. The tests include a high-risk panel for common cancers, a comprehensive panel spanning multiple cancer types, and fully-customizable panels by specialty area covering up to 114 total genes associated with inherited cancers. Genetic testing is a powerful tool for identification of individuals who are at increased risk for developing cancer. It is important for assessing cancer risk, improving cancer survival rates, and planning management of high-risk patients, including steps such as increased surveillance and targeted medication. Phosphorus's expert-curated panels, powerful data analytics, and rigorous variant interpretations have been designed and developed to ensure the most accurate results for patients. The tests are powered by next-generation sequencing technology, including comprehensive detection of copy number variants. The newly-launched genetic tests are organized into three panels-Common/High-Risk Panel for examining the most actionable and widely-recognized genes across cancer types to provide clear prophylactic and treatment options, Pan Cancer Panel for examining a broad range of genes across cancer types to give broader insight into cancer risk, and Disease-specific panels including breast, colorectal, brain/nervous system, leukemia, pancreatic, ovarian/uterine, renal, thyroid, melanoma, prostate, and pediatric cancers. ]]> https://biospectrumindia.com/news/97/8922/pranab-mukherjee-unwraps-aster-emergency-app-in-new-delhi.html https://biospectrumindia.com/news/97/8922/pranab-mukherjee-unwraps-aster-emergency-app-in-new-delhi.html Fri, 26 May 2017 11:20:00 +0530 The Aster Emergency App was recently launched at New Delhi by Dr. Azad Moopen, Founder Chairman & Managing Director, Aster MD Healthcare.  Aster Emergency App provides a real-time interface between the patient in emergency and  a GPS-enabled Aster Responder. This novel and unique concept will provide basic life support to its users. It is a user-friendly application that navigates the user to get access to basic life support help, in case of a medical emergency. The app is the link between the patient, the responder, the ambulance and ultimately the hospital. Prior to the App’s launch on May 25, 2017, a delegation led by Dr Moopen and accompanied by Ministers and MPs, briefed Pranab Mukherjee, President, Govt. of India regarding the app. The President appreciated the initiative and gave his blessings. Dr. Moopen said, “This is a new approach using technology to handle healthcare. Every single day there are innumerable emergency calls/situations that arise in India. It might take an ambulance more than half an hour to reach the patient which is a critical period." "With this App, it is possible to provide Basic Life Support guidance during the Golden Hour immediately. My wish is that this App should be functional successfully in the entire country. We look forward to launching this App across India in association with interested healthcare organizations, NGOs and Government Agencies. This is a neutral, not for profit initiative to save lives and we are ready to share the technology and support anyone interested to take this up.”, he added   ]]> https://biospectrumindia.com/news/97/8861/new-hope-in-a-ground-breaking-clinical-trial.html https://biospectrumindia.com/news/97/8861/new-hope-in-a-ground-breaking-clinical-trial.html Fri, 19 May 2017 16:50:00 +0530 Researchers at the University of Southampton and the University of Leicester are trialing a drug that could boost the body's immune system to fight off mesothelioma, which can be caused by asbestos. The trial will be one of many to be conducted at the University of Southampton's Centre for Cancer Immunology, which will be the UK's first and only center dedicated to cancer immunology research. Current treatment methods include chemotherapy, radiotherapy or surgery and are mainly aimed at keeping the cancer under control. The phase III randomized controlled trial, which is funded by Cancer Research UK and supported by Bristol Myers Squibb, will test whether nivolumab, a drug already used to successfully treat advanced melanoma and advanced kidney cancer, can be used to target mesothelioma. The trial has been launched ahead of International Clinical Trials Day, which is marked on 20 May each year. The trial, which is being run in collaboration with the clinical lead Professor Dean Fennell at the University of Leicester, plans to recruit 304 patients, who have relapsed mesothelioma, across 20 UK-wide sites including Southampton and Leicester. ]]> https://biospectrumindia.com/news/97/8850/a-clinical-trial-of-type-2-diabetes-drug-saves-life-of-bristol-man-.html https://biospectrumindia.com/news/97/8850/a-clinical-trial-of-type-2-diabetes-drug-saves-life-of-bristol-man-.html Wed, 17 May 2017 18:55:00 +0530 When blood tests during the trial revealed some worrying signs, Mel Reynolds took part in the long-term research into drug liraglutide which was used for treating Type 2 diabetes. “As I was on the diabetes trial, at the hospital they used to take my blood and blood pressure and weight every three months, whereas down the doctors it was once a year”, said Mr. Reynolds to Bristol Post. “When they analysed my blood they discovered I had cancer and I’d had no symptoms whatsoever. “They said if I wasn’t on the diabetes trial I wouldn’t be here now because it would have been too late.” Mr Reynolds’ wife Jane, 55, said she was initially “dead against” her husband taking part in the trial at Southmead Hospital. She said: “I just didn’t know what he was putting into his body. They said it was safe and had already gone through all these other trials but you still wonder if it is, so I was worried. “I always push him to do anything that’s going now. “We owe more than you’ll ever know. I recommend taking part in research trials to everybody.” The research was carried out to ensure the drug, which was already used by the NHS, would not cause risks to people with cardiovascular conditions as well as diabetes. Clinical research trials are funded by the National Institute of Health Research (NIHR) with the help of the Clinical Research Network (CRN) and are used to ensure NHS treatments are evidence-based. Three months into the trial, the regular blood tests showed that Mr Reynolds’ amalayse and lipase were elevated, suggesting there was a problem.Mr Reynolds underwent surgery at the Bristol Royal Infirmary two weeks later – he has now been cancer free for five years. The couple are sharing their story ahead of International Clinical Trials Day on Saturday (May 20), which aims to raise awareness about the trials and recognizes research professionals for their contributions. NIHR national director for patients and the public, Simon Denegri, said: "At the NIHR we think of patients and the public as an essential part of the research team. ]]> https://biospectrumindia.com/news/97/8839/agilent-technologies-announces-expanded-use-for-pd-l1-ihc-28-8-pharmdx-diagnostic-in-europe.html https://biospectrumindia.com/news/97/8839/agilent-technologies-announces-expanded-use-for-pd-l1-ihc-28-8-pharmdx-diagnostic-in-europe.html Mon, 15 May 2017 15:10:00 +0530 Agilent Technologies Inc. recently announced the expanded use of Agilent´s Dako PD-L1 IHC 28-8 pharmDx test for squamous cell carcinoma of the head and neck (SCCHN), the most prevalent type of head and neck cancer.Europe is the first region to launch a PD-L1 CE-IVD test for SCCHN globally. The CE marking demonstrates that the product meets all relevant European Medical Device Directives. The PD-L1 IHC 28-8 pharmDx test has broad utility, as it has already been previously CE marked for tumor cell PD-L1 expression for non-squamous, non-small-cell lung cancer (ns-NSCLC) and melanoma.With this latest indication, pathologists in Europe now have access to a clinically validated test to determine tumor PD-L1 status PD-L1, in patients with SCCHN. There are currently few treatment options for SCCHN, but this new test can identify which patients could most likely benefit from treatment with Opdivo (nivolumab), an immunotherapy developed by Bristol-Myers Squibb. Opdivo as monotherapy is indicated for the treatment of squamous cell cancer of the head and neck in adults progressing on, or after platinum-based therapyImmunotherapies are designed to help an individual´s immune system detect and kill cancer cells. Because individual patients often respond differently to the same treatment, scientists have been focusing emphasis on personalized medicine, which is where Agilent´s Dako brand of diagnostics comes into play, providing important information about the status of key biomarkers in individual cancer patients.Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group said, “It is encouraging to see new indications validated both analytically and clinically, for the PD-L1 28-8 assay,”  “We recently saw the first approval for the PD-L1 IHC 28-8 pharmDx test, in head and neck cancer in Japan, and are now pleased that the CE marked indication has been extended to Europe. Head and neck cancer has few treatment options, and tumor PD-L1 testing can identify patients with this devastating disease who are most likely to benefit from Opdivo therapy", he addedPD-L1 IHC 28-8 pharmDx is the first and only diagnostic assay approved to assess the survival benefit with Opdivo in patients with SCCHN and was developed in collaboration with Bristol-Myers Squibb. ]]> https://biospectrumindia.com/news/97/8785/a-clinical-study-agreement-between-regeneron-and-inovio.html https://biospectrumindia.com/news/97/8785/a-clinical-study-agreement-between-regeneron-and-inovio.html Mon, 08 May 2017 17:40:00 +0530 Regeneron Pharmaceuticals, Inc. and Inovio Pharmaceuticals, Inc. announced a clinical study agreement for a Phase 1b/2a immuno-oncology trial. The study will be conducted by Inovio in patients with newly-diagnosed glioblastoma multiforme (GBM) and will evaluate Regeneron's PD-1 inhibitor, REGN2810, in combination with Inovio's INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12. The open-label trial, which is expected to begin later this year, is designed to evaluate the safety and efficacy of the combination therapy in approximately 50 patients. The study will be conducted at 30 U.S. sites and the primary endpoints are safety and tolerability. The study will also evaluate immunological impact, progression-free survival and overall survival. GBM is a devastating disease for both patients and caregivers. It is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last ten years. Under the terms of the agreement, the trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon study design, and Regeneron will supply REGN2810 (a PD-1 checkpoint inhibitor). Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, in collaboration with Sanofi, is developing REGN2810 both alone and in combination with other therapies for the treatment of various cancers. ]]> https://biospectrumindia.com/news/97/8749/amtz-to-host-first-help-desk-on-new-medical-devices-rules.html https://biospectrumindia.com/news/97/8749/amtz-to-host-first-help-desk-on-new-medical-devices-rules.html Wed, 03 May 2017 12:14:38 +0530 The Andhra Pradesh MedTech Zone (AMTZ) has been chosen to host Government of India’s first dedicated ‘help desk of medical devices rules, 2017’ to facilitate free flow of information to medical device manufacturers and help improve manufacturing potential of the sector. The help desk will function as a single point of contact for medical devices manufacturers to access information regarding the changes in Medical Devices Rules. It will facilitate information on regulation of medical device with classification system; licensing authorities and functions of notified body; manufacture of medical devices for sale and distribution; import and labelling of medical devices; and clinical investigation of medical device and clinical performance evaluation of IVD’s. The AMTZ desk would also provide information to manufacturers on import or manufacture of medical device which do not have predicative device; duties of medical device officer, medical device testing officer and notified body; registration of laboratory for carrying out test for evaluation; and sale of medical devices, etc. Making a humble start, AMTZ is growing from strength to strength to carve out its own path to help India emerge as a global hub for medical device manufacturing. Owing to the good response AMTZ has received, the Association of Indian Medical Device Industry (AiMED) has lauded the first ultra- modern medical equipment manufacturing zone of India for commencing booking of plots. AMTZ also received applauds at Indian Medical Device Conference – 2017, one of the largest events for the Indian pharmaceutical market, where AMTZ occupied the centre stage. ]]> https://biospectrumindia.com/news/97/8744/skinceuticals-announces-partnership-with-resurge-international-.html https://biospectrumindia.com/news/97/8744/skinceuticals-announces-partnership-with-resurge-international-.html Tue, 02 May 2017 16:46:46 +0530 SkinCeuticals is born from science, rooted in the belief that knowledge is power, and committed to doctors in the field of skin health and aesthetics. Through its new partnership with ReSurge International, the brand announces an initiative for Pioneering Women in Reconstructive Surgery, to technically train, professionally mentor, and develop in leadership first generation female surgeons in order to increase access to reconstructive surgical care in under-served parts of the world. For people in developing countries who suffer from burn injuries or congenital conditions, a change in their appearance can change their lives enabling them to fully participate in their communities, attend school, and provide for their families. For these people, reconstructive plastic surgery is transformative at many levels yet 5 billion people worldwide lack access to safe, timely surgical care. SkinCeuticals believes that equality of medical training is essential to meeting this need. Today, there are only three female surgeons for every 1 million people in low income countries, often due to a lack of equal access to significant technical training or obstacles to gaining acceptance in their field. SkinCeuticals and ReSurge International aim to correct this imbalance.  Through visiting educator programs, leadership training, mentorship support, and funding of supplies, Pioneering Women in Reconstructive Surgery will help female surgeons grow their knowledge and as a result, provide networks of reconstructive surgical care within their communities. The first year of the partnership will focus on five up-and-coming female surgeons – Dr. Faith Chengetayi Muchemwa of Zimbabwe, Dr. Celma Marina Teles Issufo of Mozambique, Dr. Shilu Shrestha of Nepal, Dr. Lorena Escudero Castro of Ecuador, and Dr. Farzana Bilquis Ibrahim. ]]> https://biospectrumindia.com/news/97/8725/hospital-successfully-performs-robotic-surgery-to-treat-patients-with-rare-medical-condition.html https://biospectrumindia.com/news/97/8725/hospital-successfully-performs-robotic-surgery-to-treat-patients-with-rare-medical-condition.html Mon, 01 May 2017 11:55:00 +0530 A rare medical condition, Celiac Artery Compression Syndrome which is characterised by acute abdominal pain has been successfully treated by robotic surgery at a hospital in Ahmedabad. Surgery is currently the only treatment option and involves releasing the ligament that causes the compression. However, reaching the celiac artery through conventional surgery is not easy because it is located deep under the crus of the diaphragm. Apurva Vyas, Gastro intestinal surgeon, Sterling Hospital said, "Using a four-armed surgical robot, I was able to reach the root of the celiac artery where human fingers could not. He used the da Vinci surgical robot for the procedure. "The three-dimensional high definition view magnified the artery multi-fold to help me achieve precision that prevented collateral damage to healthy tissue, arteries and nerves. I was happy to see the patient recover quickly. He was back home on the third day post surgery.” he added Celiac artery compression can be loosely compared to a heart attack-like situation of the digestive system. The patient suffers severe pain as soon as he starts eating and is hardly able to eat enough for the body's needs.   ]]> https://biospectrumindia.com/news/97/8721/apollo-hospital-implants-worlds-smallest-pacemaker.html https://biospectrumindia.com/news/97/8721/apollo-hospital-implants-worlds-smallest-pacemaker.html Fri, 28 Apr 2017 16:32:55 +0530 Apollo BGS Hospital, Mysuru, became the first hospital in the State to implant the world’s smallest pacemaker into a 68-year-old patient with bradycardia. The implant was performed by Dr. Arun Srinivas, Head of Cardiology Department & Interventional Cardiologist, Apollo BGS Hospital, along with Dr. H.P. Guruprasad, Dr. P. Jayakumar and Dr. Adithya Udupa. The 68-year-old patient had a reaction from a previous implanted regular pacemaker, due to which it had to be removed. Since his veins were blocked, which are normally used for regular pacemaker leads, his only lifesaving option was the new Leadless pacemaker, which was implanted through the leg. It attaches directly to the walls of the heart and gives electrical signals for maintaining a normal heart rate. This new pacemaker is entirely MRI compatible, which can adjust the heart rate according to the patient’s activity and needs of the body. The Leadless Pacemaker also incorporates a retrieval feature to enable retrieval of the device when possible; however, the device is designed to be left in the body and the miniaturised leadless pacemaker is designed with a unique feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction. ]]> https://biospectrumindia.com/news/97/8718/united-therapeutics-partners-with-3-d-printer-to-make-human-organs.html https://biospectrumindia.com/news/97/8718/united-therapeutics-partners-with-3-d-printer-to-make-human-organs.html Fri, 28 Apr 2017 16:22:59 +0530 3D Systems has announced a bioprinting agreement with United Therapeutics which will see the two companies develop solid-organ scaffolds for human transplants with 3D printing. Combining their respective expertise in 3D printing and regenerative medicine and organ manufacturing, the collaboration will remain for a number of years. The agreement will pit 3D Systems personnel alongside professionals from a United Therapeutics subsidiary, Lung Biotechnology PBC. Since the collaboration will primarily focus on the development of 3D printing systems for solid-organ lung scaffolds, Lung Biotechnology PBC is seen as best placed to work with 3D Systems. The printing system will target collagen, and other building block proteins, as scaffold raw materials. Lung Biotechnology PBC will cellularize the scaffolds with patient-specific biological material, including re-differentiated stem cells. 3D Systems is a company with a wealth of experience in the medical sector. Its precision healthcare capabilities include simulation, virtual surgical planning, and the printing of medical and dental devices. The collaboration and joint development will add another technology alternative to United Therapeutics’ pursuit of an unlimited supply of organs for human transplantation. ]]> https://biospectrumindia.com/news/97/8702/transasia-bio-medicals-acquires-calbiotech-group-of-us.html https://biospectrumindia.com/news/97/8702/transasia-bio-medicals-acquires-calbiotech-group-of-us.html Thu, 27 Apr 2017 17:21:32 +0530 Strengthening its foray into immunoassay, Transasia Bio-Medicals Ltd., India’s leading in-vitro diagnostic company, has recently acquired Calbiotech Group of Companies in the US through its German subsidiary Erba Mannheim. With this new addition, the Transasia-Erba Group is all set to strengthen its foray in ELISA and CLIA assays for human and animal research, including specific assays for autoimmune disorders, cancer and infectious diseases. The California-based Calbiotech Group is a global leader in immunoassay development and manufacturing. Whereas, Transasia Bio-Medicals Ltd offers a comprehensive product portfolio spanning all specialties of diagnostics including biochemistry, hematology, immunoassay and blood banking, urinalysis, diabetes, critical care, coagulation, microbiology and molecular diagnostics.  Along with its subsidiaries in Germany, France, Czech Republic, Russia, Turkey, the UK and USA, Transasia now reaches out to millions in over 104 countries. ]]> https://biospectrumindia.com/news/97/8697/new-genetic-testing-for-lung-cancer.html https://biospectrumindia.com/news/97/8697/new-genetic-testing-for-lung-cancer.html Thu, 27 Apr 2017 16:47:36 +0530 The new test has been created by Gary A. Pestano, Ph.D., and colleagues from Biodesix, Inc., a molecular diagnostic company based in Boulder, CO. Lung cancer is one of the most common cancers in the United States out of which non-small cell lung cancer (NSCLC) accounts for around 80-85 percent of lung cancers. The most common subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Patients with NSCLC may possess certain gene mutations. At present, the type of treatment provided for NSCLC is usually determined using a lung biopsy, which involves removing a sample of tissue or fluid from the lungs for analysis. According to the researchers, the new test utilizes a technique called Droplet Digital PCR, or ddPCR, which is a highly sensitive gene mutation detection method that is based on the partitioning of DNA into droplets. The technique is able to identify specific DNA mutations and RNA variants from tumors that are circulating in the blood. The team used the test to analyze more than 1,600 blood samples taken from patients with early-stage NSCLC. The results of the test were available within 72 hours.   ]]> https://biospectrumindia.com/news/97/8690/ncbs-tifr-aims-to-garner-funds-to-bolster-lifesciences-research.html https://biospectrumindia.com/news/97/8690/ncbs-tifr-aims-to-garner-funds-to-bolster-lifesciences-research.html Thu, 27 Apr 2017 16:07:30 +0530 NCBS-TIFR which houses the Bangalore Life Science Cluster for advancing modern biological research, has created an Endowment Fund. The Centre intends to garner Rs. 25 crore for this endowment fund to commemorate its silver jubilee this year. Biocon chief Kiran Mazumdar-Shaw has provided Rs. 5 crore as endowment funding support. Three premiere institutions including NCBS-TIFR, the Institute for Stem Cell Biology and Regenerative Medicine (inStem) and the Centre for Cellular and Molecular Platforms (C-CAMP) are together creating opportunities at the cluster for a range of research activities from basic biology to application-oriented biotechnology. Most of the world's top research institutes further their work through a mixed portfolio of conventional and unrestricted support. Endowment funds at organizations worldwide provide significant support to their activities. NCBS-TIFR aims to eventually build, by the year 2020, a significant corpus to provide flexible support for research in a dynamic environment. Dr Mazumdar-Shaw's donation towards the Endowment Fund at NCBS-TIFR is one in perpetuity. The fund will remain intact as a core investment, with only the interest being used for various activities, the foremost being the advancement of promising but bold research projects. In particular, the fund will support early stage research and innovation deemed too risky for conventional funding mechanisms, national and international collaborations and outreach of research for societal impact. ]]> https://biospectrumindia.com/news/97/8687/gujarat-fdca-to-launch-first-mobile-drug-testing-lab-in-india.html https://biospectrumindia.com/news/97/8687/gujarat-fdca-to-launch-first-mobile-drug-testing-lab-in-india.html Thu, 27 Apr 2017 15:58:36 +0530 The Gujarat Food and Drug Control Administration (FDCA) is all set to launch India's mobile testing lab equipped with high-tech devices in the state by the end of June.One of the best features of this high tech testing lab is its safety feature which allows it to give on the spot results of the drugs tested without causing any damage to the original samples. The mobile drug testing lab is equipped with a near infrared spectrophotometer, x ray fluorescence spectrometer, an ion mobility spectrometer and a Raman spectrophotometer. The total cost of the project comes to about Rs one crore.The mobile lab will enable state drug regulatory officials to check production of spurious or substandard drugs across the state. For the organization, patient safety is the main goal and a commitment towards providing best healthcare services to patients by adopting better ways to strengthen the drug regulatory system in the state. Depending on the success of the project, FDCA may acquire and deploy more such mobile vans in the state. ]]> https://biospectrumindia.com/news/97/8663/illumina-launches-trusight-tumor-170-.html https://biospectrumindia.com/news/97/8663/illumina-launches-trusight-tumor-170-.html Wed, 09 Nov 2016 12:37:46 +0530 Illumina, Inc. has announced the launch of TruSight Tumor 170, a 170 gene next-generation sequencing solution to support the transformation of the tumor-profiling paradigm from a series of single-gene tests to a multi-analyte approach, providing a more thorough picture of a tumor's genomic landscape. TruSight Tumor 170 offers an integrated DNA and RNA enrichment-based workflow, targeting cancer-related genetic aberrations, including small variants, gene amplifications, gene fusions, and splice variants. With optimized bioinformatics tools and automation options, laboratories can implement the assay on an in-house, research use only NextSeq instrument. Designed to support limited nucleic acid input from formalin-fixed, paraffin-embedded (FFPE) samples, TruSight Tumor 170 facilitates efficient evaluation of biomarkers. "Having broader gene content allows us to improve cancer research by assessing more genes and to identify structural alterations that are important targets for developing therapies," said pathologist Anthony Magliocco. "We hope these capabilities will improve clinical cancer research by streamlining the testing of solid tumors. Due to the flexibility of the enrichment methodology upon which TruSight Tumor 170 is based, this technology has the potential to serve as a platform for many applications beyond solid tumor profiling." "This new assay is poised to help realize the potential of precision oncology," said John Leite, PhD, Vice President of Oncology at Illumina. "By integrating DNA and RNA into one protocol, clinical researchers are able to accelerate comprehensive analysis of cancer-related variants and maximize the data obtainable from precious specimens. Looking forward, we aim to deploy the underlying assay method at the heart of TruSight Tumor 170 as a universal standard for optimized tissue assessment across a variety of applications with both fixed and customizable panels." "We're committed to delivering the tools that enable a shared vision of personalized oncology," said Francis deSouza, President and CEO of Illumina. "We believe the introduction of TruSight Tumor 170 will enable research insights that will positively impact cancer patients in the future."   TruSight Tumor 170 offers broader investigational power: • Enrichment-based assay that evaluates DNA and RNA in one integrated protocol • 170 unique genes informed by partnering pharmaceutical companies, academic community leaders, and industry guidance • Integrated workflow requires only 40ng of DNA and RNA from FFPE samples, allowing more comprehensive testing while preserving precious samples • Underlying assay method to serve as a standard for optimized tissue assessment across a variety of applications     ]]> https://biospectrumindia.com/news/97/8661/siemens-healthineers-acquires-conworx-technology-gmbh-.html https://biospectrumindia.com/news/97/8661/siemens-healthineers-acquires-conworx-technology-gmbh-.html Wed, 09 Nov 2016 12:36:37 +0530 Siemens Healthineers has announced the company is expanding its informatics capabilities for point-of-care testing with the acquisition of Conworx Technology GmbH, the Berlin-based developer of point-of-care device interfaces and data management solutions. The addition of the Conworx suite-including UniPOC and POCcelerator-complements the Siemens Healthineers award-winning RAPIDComm Data Management System and will elevate the informatics offerings for the point-of-care market by delivering open connectivity for more than 100 different instruments from all major manufacturers. This acquisition is another proof point of the Siemens Healthineers strategic direction to enable healthcare providers around the world to meet their current and evolving challenges and to excel in their respective environments. Through products and solutions designed to increase efficiency and to reduce costs, Siemens Healthineers is setting new trends in healthcare together with its customers-working under the motto "Engineering Success. Pioneering Healthcare. Together." As the trend of consolidation and industrialization in healthcare continues and regulatory requirements for point-of-care testing intensify, the need for sophisticated informatics to communicate instrument and patient data at the point of care becomes increasingly important. Siemens Healthineers and Conworx will deliver open connectivity offerings that will enable seamless data integration from any manufacturer's point-of-care analyzer-managed by a single informatics solution to streamline operations and access to data, and improve risk management. "As hospitals consolidate and acquire physician offices, there is a huge need by emerging healthcare networks for seamless integration of hundreds of decentralized devices that are spread across dozens of sites," said Peter Koerte, President, Point of Care Diagnostics, Siemens Healthineers. "It is clear to us that to satisfy our customers' needs, we must deliver solutions that ensure superb connectivity, no matter which analyzer is being connected. We are determined to continue Conworx's practice of working closely with every vendor to ensure that all connected analyzers are working to the best of their ability."   Now a wholly-owned subsidiary of Siemens Healthcare GmbH, Conworx's team of 75 employees will merge with the Siemens Healthineers team to become Siemens Healthineers Point of Care Informatics. This new team of interface development, application development and data management specialists will be led by Roman Rosenkranz, the current CEO of Conworx Technology GmbH. "By joining with Siemens Healthineers, we will get access to a global organization to even better support our joint customer base," said Roman Rosenkranz, CEO of Conworx Technology GmbH. "Together we will be able to develop leading informatics products that help our customers to manage their growing point-of-care networks now and in the future." Conworx Technology GmbH was established in 1999. The deal was closed by Siemens Healthcare GmbH in late October 2016.   ]]> https://biospectrumindia.com/news/97/8659/thermo-fisher-scientific-and-hamilton-storage-partner-to-simplify-sample-storage.html https://biospectrumindia.com/news/97/8659/thermo-fisher-scientific-and-hamilton-storage-partner-to-simplify-sample-storage.html Wed, 09 Nov 2016 11:03:46 +0530 For researchers seeking to streamline their sample storage processes, Thermo Fisher Scientific and Hamilton Storage have partnered to offer the fully automated Thermo Scientific Decapper 500 and 550 Series tube capping systems. For the first time, users can cap and decap both Thermo Scientific Matrix and Nunc automation tubes without owning multiple pieces of equipment. Historically, users have stored biological samples in multiple tube types, requiring them to buy multiple decappers. The new decapper system does the work of multiple systems and features Quick Switch technology that seamlessly transitions between different tube and rack types. The Decapper 500 and 550 systems are perfect for use in medium- to high-throughput biotech, pharmaceutical and clinical laboratories doing compound storage, high-throughput screening, biobanking and genomic storage. The Decapper 550 provides additional functionality with its built-in barcode reader. The decappers can also cap and decap partial racks of tubes. "To address customer demand for more flexible and functional decapping equipment, Thermo Fisher partnered with Hamilton Storage, an industry leader in cryogenic sample storage systems," said Chris Tsourides, senior business director, Thermo Fisher Scientific. "These two new decappers show what's possible when two industry innovators join forces. Together, we're delivering significant time and cost savings to scientists all over the world." "We constantly seek new ways to streamline customer efficiencies, and with Thermo Fisher as a partner, our commitment is further strengthened," adds Matt Hamilton, president of Hamilton Storage. "This means that our mutual customers will benefit from a robust, time-saving and integrated-friendly workflow solution." The Decapper 500 and 550 systems fill a gap between low-throughput, manual eight-channel handheld decappers and high throughput, entire-rack decappers for automated work stations. With the new decappers, Thermo Fisher now offers end-to-end solutions for customers' sample storage workflows, including 2D barcoded storage tubes, barcode readers, sealers and cappers. ]]> https://biospectrumindia.com/features/97/8655/digital-health-the-dawn-of-a-new-era-in-healthcare.html https://biospectrumindia.com/features/97/8655/digital-health-the-dawn-of-a-new-era-in-healthcare.html Mon, 07 Nov 2016 16:14:16 +0530 Technolgy has revolutionized almost all the sectors, healthcare being no different. This convergence of technology and healthcare has open up a whole new world of possibilities which promise to improve the quality and efficiency of various healthcare services. Technology for transforming healthcareScientists, healthcare providers, technology giants across the globe have come up with new and exciting ways to apply digital technology in healthcare to make lives easy and better. With new technology advancements, healthcare and treatment is becoming cheaper and more accessible. "The healthcare industry is realizing the potential of digital technologies, with the usage of tools ranging from smartphones and tablet computers to remote sensors and monitoring devices to deliver care, information, and support to patients where and when they need it. These technologies play a key role in closing communication gaps between providers and patients and building new care models that enable patients to get care in the most convenient, cost-effective ways. Leading healthcare organizations have started using smartphone technology and remote monitoring devices to detect changes in patients' conditions and offer real-time feedback. Technology Enabled Care (TEC) - telecare, telehealth, telemedicine, mHealth, digital health and eHealth services have and will drive the healthcare domain in the future," said a spokesperson from Cisco. According to Mr Dinesh Chindarkar, co-founder, MediaMedic Communications, "Smart phones have presented thousands of health apps that enable users to track their health minute by minute. All types of diseases have some or the other value added apps and have become a part of our lives. With increasing smartphone penetration and usage it is further going to boom. Telemedicine is one more area that helps doctors connect with their patients no matter where they are. In the rural sector this has larger implications. With an increasing use of internet and smart phone, patients now find it easy to access to various doctor specialities without wasting precious time." People are more aware of their health today. Health-related information is more easily available. Earlier, ways to measure health parameters were only available with a doctor or at a hospital, but now information is available on mobile phone. In addition, hospital visits take time and can be inconvenient. Cost of healthcare is also rising. It is becoming increasingly important to detect early and take preventive care.   "Devices are needed to measure parameters and process applications that help keep track health on an ongoing basis. But patients are reluctant to enter data either because it is cumbersome or they find it a chore to do - on an ongoing basis. Thus there is a need for an integrated system where things are measured on their own without patients' having to bother entering data all the time. Weight is just one of the parameters; calories, glucose levels are some of the other indicators that need to be tracked," said Mr Dalip Singh Negi, VP - Engineering, Portea Medical. Innovations in the health technologyThe innovations in the health technology has grown leaps and bounds in the recent times. Wearable devices such as smart watches, health patches to monitor patient's vitals, glucose monitoring system to high tech innovations such as state-of-the-art prosthetic limbs have all hit the market. Further, remote patient monitoring through mobile health technology promises to deliver quality outcomes at lesser costs and reduced time. Augmented and Virtual reality are simplifying & revolutionizing healthcare in a big way. "Technologies include those that are directly accessible on a mobile device such as BP monitors and those solutions that enable mobile healthcare delivery. The next level of innovation will be around using sensors in mobiles to measure parameters. Mobiles with high magnifying cameras can be used in conjunction with an app to perform optical tests. Next level is to move away from external devices and use a good camera and mobile to do any tests which is non- intrusive," said Mr Negi. With the usage of mobile devices, wearables and electronic records healthcare providers have access to information in real time which improves the health care provision. With the help of technology, it is easier to collect and integrate data from these devices resulting in quick and better services. "The coming years are expected to witness greater deployment of tools such as telemedicine, teleradiology, Hospital Information Systems (HIS)/ Hospital Management Information Systems (HMIS), online or Electronic Medical Records (EMR), etc," said Cisco. Adoption of new technology in healthcareHealthcare has been a little traditional as an industry but technology adoption is picking up steadily. Technology has trickled down to building intelligent infrastructure for the healthcare service provider, with open interfaces, and helps them improve network security, reliability, simplicity and innovation at an unprecedented scale. "Various healthcare players have effectively used technology - look at the hospital segment who has changed the way healthcare is delivered. Recent time-bound organ transplant cases in India could have never been thought about without technology. Newer devices, lateral thinking and the young Indian digital natives will further revolutionize technology adoption in the time to come," said Mr Chindarkar. According to a recent report by Nasscom, the Indian healthcare IT market is valued at $1billion and is predicted to grow about 1.5 times by 2020."Internet of Things (IoT) and Big Data analytics will continue to drive adoption of digital technology in the healthcare sector, as increasing penetration of wearable gadgets, the customer's proactive approach towards health, and vast data generation helps enterprises to study and explore new market opportunities. For this sector, the next few years will be critical in order to integrate data from legacy systems and new-generation IoT devices into a connected platform to enhance functionality and minimize errors that will deliver a seamless experience to clinicians and patients," said Cisco. However, there are a few barriers which stops digitization, points Mr Negi. He said, "Innovation is still being driven by the US and the costing is based on this and devices are getting manufactured in developed markets, adjusting costs to the local environment is still a factor. Also, in India, bandwidth is a huge issue. Reliability and costs are prohibitive. The reliability of power is also a question which brings up the difficulties in handling remote healthcare monitoring." He further added, "Health consciousness is still not prevalent among the general population - Usage of devices is low. Doctors are not comfortable dispending treatment or advice without meeting patients and vice - versa with patients still preferring the conventional method of in-person meetings." There is also a lack of regulation and standardization. Moreover, innovation is needed on the hardware side. How telecomm is enabling digital healthTelecommunication and connectivity is the pre requisite for any group interworking. Any work flow beyond hospital needs telecommunication. Also, in India doctor, patient ratio is very poor, here telemedicine comes to the rescue. "Today, the technology is getting converted to three separate areas, i.e collection of basic data, transmission of the data and analysis of the data. Earlier, these three were integrated in any biomedical equipment. Now, the whole equipment chain is separating it out and this is happening so that you can have larger coverage area, lower cost and can also have the combination of multiple parameters rolled into one because you can always deploy multiple type of data collection. The one area in which telecomm plays a big role, it's called machine to machine communication where, you have sensors, health, biometric, sensors and then you are collecting all that information in a centralized place where you are analyzing it and separating out. This new workflow will have a very big impact," said Mr Vipin Tyagi, executive director, C-DOT. He further added, "We also are talking about high-end super speciality hospitals, where sophistication has to be as par the standard of the western both in terms of connectivity of the equipment for diagnosis and also for entertainment of patients. The hospitals need high speed broadband (true broadband) for faster image transfer and also for video conferencing etc. Completely connected ecosystem is required in these kind of sophisticated hospitals." Role of 'Digital India' in digitizing healthcareHealthcare in our country had multiple pain points. The structural opacity and lack of access to information led to a situation where the consumer was misled by multiple intermediaries. "With GOI's "Digital India" initiative, we believe healthcare industry will overall benefit through better access to quality information, real time connectivity with healthcare providers and greater transparency," said Dr Sanjiv Agarwal, MD & founder, Diabetacare. Echoing similar views, Mr Chindarkar said, "Smart cities, thousands of ASHA workers working at the grass root level, telemedicine initiatives to connect villages to nearby districts providing better expertise, consumer education in native languages through messaging services, call center support all will help shape a better healthcare picture with the Digital India initiative. Especially in a country where the doctor to patient ratio is poor, this will help bridge that gap and provide affordable yet precise health solution." There are many fundamental ways in which technology can solve a many of the problems which plagues the healthcare industry in India, says Dr Agarwal.He added, "Through ePharmacy, eDiagnostics, eInsurance etc, consumers in different parts of the country can access medication at their doorstep through a well tracked system. This has helped strengthen the authenticity in the supply chain, ensure better access and provide convenience to the patient. This has also helped address the deep rooted issues like middlemen taking commission to procure medicines (often fake and without a bill) etc." He further added, "Online models for healthcare, be it access to doctors, pharmacy or diagnostics ensure all the information is available at the patient's fingertips. Hence a consumer can compare prices, learn about more cost effective options and make sure they are not taken for a ride. They can also seek second opinion from doctors, get reviews or discuss their problems with people facing similar medical challenges through various online forums." However, Mr Negi feels the larger impact will be known in the coming years as it is still early days. In the Box:Start-up wave in the digital health space:Below is the list of start-ups that are leveraging the power of technology to improve the healthcare scenario in the country:Cardiac Design Labs have developed MIRCaM, an ambulatory cardiac monitoring and diagnosing system which is capable of real-time, intelligent, and full disclosure monitoring, analysis and diagnosis of a wide range of cardiac conditions like arrhythmia, myocardial ischemia and infarction.Cooey is an end to end health monitoring IoT platform that intends to collect (device), store, analyze and provide insights of vital signs for patients. HealthZwealtH Technologies provide innovative product in order to efficiently manage health profile. They help organize personal health records with robust safety and security measures.Preva systems leverage identity, location, mobility and ambiance information from sensors to provide real time analytics to enterprises. They have come up with a solution to support independent living for elders.Bangalore-based GetActive introduces fitness and sleep tracker band, a simple and accurate wearable device to track your steps, sleep, calories burnt and the distance travelled.DUCERE TECHNOLOGIES' Lechal is the world's first haptic footwear. Offering hands-free navigation and fitness tracking, this smart footwear is uniquely interactive and intuitive.NetMeds Marketplace Ltd. (netmeds.com) is an online pharmacy In the Box: Initiatives towards digital health:In 2015, the government rolled New Health Policy (NHP). The policy increased the healthcare expenditure and proposed to enact a national health rights act to make healthcare a fundamental right.e-Health was one of the initiatives launched with the Digital India campaign. It aims to provide effective, economical and timely healthcare services to all individuals, and especially to those people who have little access to healthcare services. This service will be linked to Aadhaar numbers, which will make getting lab reports and OPD appointments easier. An eHospital App has also been launched with an Online Registration System (ORS). This initiative allows us to skip the hassles of registration and other formalities required at hospitals.Ministry of Health and Family Welfare has released a concept note discussing establishment of the National eHealth Authority (NeHA) for India.   ]]> https://biospectrumindia.com/news/97/8658/gst-may-not-benefit-patients-health-care-consumers.html https://biospectrumindia.com/news/97/8658/gst-may-not-benefit-patients-health-care-consumers.html Mon, 07 Nov 2016 16:13:34 +0530 All this huge expectation on GST being a boon for consumers is an overly hyped expectation as products other than consumer durables are usually sold on MRP including taxes & not on transaction value, so last seller (whether retailers or hospitals )who will gain on lower cost of procurement will be the gainers - We doubt if many(or any)will pass on this cost savings benefit to consumers as an MRP, less a discount! So impact for consumers may be Nil. Currently on most medical devices it's 6% Excise and 2% CST - approx 8 % .So a 5% GST on transaction value and 1% GST on MRP would keep it overall similar for those manufacturers whose MRP is a nominal 3 times the Ex factory price . If someone is charging MRP at 10 times (or higher )then he will be severely impacted and he will be motivated to reduce his MRP to avoid paying high GST cess. The 1% Cess on MRP (at 10 times ) will then be equivalent to 10% GST - so impact will be approximately 15% against 8%. CII and FICCI medical devices forum ( read MNC importers) are lobbying for 0% GST.This is not desired as then we Domestic manufacturers can't claim modvat on our inputs and would need to increase our Ex- Factory prices to maintain our margins . For Imports price need not increase . So that's why Zero duty or too low duty where a manufacturer is unable to write off the modvat / GST paid on your inputs viz. raw materials/ consumables/ capital goods / services, becomes counter productive , as then these get added as costs and leads to inflation on ex factory price which is not the case with imports . For Medical Devices we expect GST to be at 5 or 12 % .Nil GST will make Indian products non competitive against imports . Higher GST will lead to higher competitiveness of Indian manufacturers against imports upto a certain point , beyond 18 % GST it will curb consumption or there will be risk of grey market in service industry - professionals/ Healthcare services etc . We would recommend keep all services at a nominal GST of 12% for general services or lower of 5 % for Healthcare. A corporate subcontracting out services can set of GST paid on services but not an Individual Consumer. If government has to motivate consumers to be honest tax payers best it is to keep it reasonably low. For Medical Devices and other FMCG it may be a good idea to put a 1% GST cess on MRP ( not transaction value) on all medical devices and consumer goods to control artificial inflation- this will penalize manufacturers and importers putting a high MRP on their products and reward those putting a low, reasonable MRP . This will be a deterrent to using High MRP as an inducement to retailers and hospitals to push their products - which is already leading to rapid artificial inflation in the country as competitiveness has got skewed- it's no more about more value for same (or lower price) , it's become who offers a higher margin to the trade - consumer be damned ! Ethics ? These are forcefully being kept aside as you either play the game or be jostled out of the retail shelf space . Also why too many slabs - 0%, 5%, 12%, 18%, 28 and 28+Cess (?) Why not keep it simple as in most countries so one is motivated to be honest ? Three or max four slabs were good enough. Now it will lead to political and lobbying forces in play (and pay) for moving from one slab to another ! Govt has mooted putting a Cess on GST on luxury goods. GST cess should not be linked to luxury goods , it should be linked to trade margins - so if they are high or excessive you pay higher cess!   ]]> https://biospectrumindia.com/interviews/97/8651/the-medical-device-industry-is-driven-by-innovation-and-new-technologies.html https://biospectrumindia.com/interviews/97/8651/the-medical-device-industry-is-driven-by-innovation-and-new-technologies.html Fri, 04 Nov 2016 11:47:00 +0530 Started in 1997, Poly Medicure Ltd is a leading Medtech company which produces more than 100 different types of medical devices. The firm has six manufacturing facilities including in India China and Egypt. It exports products to more than 90 Countries.Mr. Himanshu Baid, MD, Poly Medicure tells us more about the company, innovation put to practice, Medtech landscape in India etc. Edited Excerpts: 1) Please introduce PolyMedicure? What are your areas of focus as far as product services are concerned? We, Poly Medicure Limited (POLYMED) are one of the leading manufacturer and exporter of medical devices with dominant position in disposable medical devices market with focus on innovation, safety and quality and have a vision to provide highest quality of healthcare available to all. We manufacture and supply, in India and internationally, a diverse portfolio of over 100 varieties of disposable medical devices, including veterinary disposable devices. We currently have six (6) manufacturing facilities across India, China and Egypt. In India, we have four manufacturing facilities, two of which are situated at Faridabad, Haryana, and one each in Jaipur, Rajasthan and Haridwar, Uttarakhand. One in China - wholly owned subsidiary and one joint venture in Egypt. We have over 400,000 square feet of manufacturing area with 100,000+ square feet of clean room area and state-of-the-art facilities with capacity to expand rapidly. Our employees contribute significantly to our business operations. We have 1500+ employees, including over 150 engineers. We believe that our focus on innovation, safety and quality, product range and competitive pricing have enabled us to develop strong brand recognition in the Indian market and internationally.   2) Can you elaborate on your product pipeline and innovations put into practice? We have a diversified product portfolio with over 100 varieties of disposable medical devices in product verticals of infusion therapy, central venous access catheters, anesthesia, blood management and blood collection, urology, surgery and wound drainage, gastroenterology and dialysis and certain veterinary disposable devices. We have also developed a number of safety medical devices across product lines. With our existing product offering of safety medical devices in various product lines and our increasing focus on developing such products in the future, we believe we are well-positioned to benefit from increasing private and public investment in healthcare and growing demand for quality healthcare. The company has successfully implemented a QMS (Quality Management System) which has been accredited by DNV, Norway with ISO 9001:2008, ISO-13485: 2003 and CE - 0434 from DNV, Norway thus making the entire product range compliant with International Quality Standards. Based on the efforts of our research and development division, we have successfully been granted 144 product and process patents globally and have also filed for grant of an additional 394 patents in India and worldwide. 3) What are the current market trends in the medical device industry?The medical device industry is driven by innovation and new technologies. The advents of engineering innovations have led to the recent development of low cost products that are at par with existing products on quality. Availability of advanced and sophisticated medical technology is creating new markets / applications, increasing the dependence by doctors on advanced medical devices, and is leading to rapid obsolescence of existing medical technology thereby creating demand for replacement/up-gradation of products. 4) Though, India medical device industry has gained some momentum in the recent past, nothing concrete has come out of it. Your comment?Some of the key challenges facing by Indian Medical device industry includes: Unfavorable duty structure, Inadequate domestic demand for certain segments/product categories, Absence of indigenous 'quality certification' authority, Inadequate ecosystem support and ease of doing business.The recent steps taken by the Government of India to support the medical devices industry includes:• Separate Medical Device Bill- a long outstanding demand from the industry. The government recently published the draft medical devices rules for comments from stakeholders and expected to be tabled on Parliament in the 2016 winter section. • Appointing a nodal body for medical devices and improving inter-department coordination • National Medical Devices Policy - which will offer benefits to local manufacturers directly subsidize various local businesses and offer preferential tax treatment• Development of clusters to support growth and innovations and Medical Devices parks• Medical Devices covered under "Make in India"• Correction in inverted duty structure to help local manufacturing We hope with these initiatives is policy framework and ecosystem supports from government, Indian medical device industry will pick up the growth momentum and expected to be US$ 25-30 billion industry by 2025. 5) What products make up the largest faction of the company output?Infusion therapy is our key product vertical, which contributed to approximately 67% of our net revenue from operations in fiscal 2016. Our diversified product portfolio enables to cross-sell our products, thereby increasing our market share across product verticals. 6) What are your future plans? • Through our new investment of Rs. 60 crore in the green field project at IMT Faridabad in Haryana, which is geared up to commission in third quarter of 2017 with all statutory approvals, we will significantly broaden our existing manufacturing facilities to tap on new market opportunities. This will enhance our journey to capitalize on the growth opportunities in the medical devices sector and also to expand our product offerings by introducing a slew of products • Our new Research and Development center in Faridabad is ready to be operational by Quarter 3 of the fiscal 2016. This will double our current infrastructure for tooling and design. Added 15-20 qualified dedicated research staff and state-of-art software's will help us in creation of new generation of medical devices • We are introducing new products in Gastrology, Oncology, Nephrology and Respiratory care. Scheduled to add more diethylhexyl-phlthalate (DEHP) & polyvinyl chloride (PVC) free range of products in the portfolio which will provide better patient care and safety. • Our Domestic Sales & Marketing future plans includes vast brand awareness and product training campaigns by our existing 190+ sales team by conducting medical education programs in key hospitals in the Country. We are also planning to double our sales team strength in next 3 years to reach out 10000+ hospitals across India. • International market strategy includes: Increase the basket of products with existing customers, Organizing Training Program for Global Distributors, Participation in various conferences and exhibitions, appointment of representatives in key markets. • We are in the process of implementing SAP based ERP solution which will increase our productivity, significant cost savings and more consistent operations • We believe that enhancing our manufacturing capabilities and further diversifying our product portfolio will enable us to capitalize on expected growth opportunities in this sector and increase our market share in the domestic and international markets. • We intend to continue our initiatives on Innovation & greater manufacturing excellence create better awareness of products, pass benefits of cost savings to stakeholders community including patients.   ]]> https://biospectrumindia.com/interviews/97/8653/it-is-revolutionizing-the-healthcare-industry-slowly-but-steadily.html https://biospectrumindia.com/interviews/97/8653/it-is-revolutionizing-the-healthcare-industry-slowly-but-steadily.html Fri, 04 Nov 2016 11:46:00 +0530 1. Though IT has revolutionized almost all of the major sectors, Healthcare remains rather the poor user of IT, why? According to the sixth edition of consulting firm Deloitte Touche Tohmatsu India Pvt. Ltd's 2016 predictions, the overall Indian healthcare market that is worth $100 billion is expected to grow at a 23% CAGR (compound annual growth rate) to reach $280 billion by 2020. The researchers at Deloitte believe that this growth will be accelerated by digital adoption. The healthcare industry worldwide has been experiencing a transformation which is being shaped by information technology's key role. In India too, while the adoption has been slow, IT is increasingly making inroads into the industry. Digital evolution is changing the way doctors and patients interact, the way medical records are maintained and improving collaborative data exchange. IT is revolutionizing the healthcare industry slowly but steadily. 2. What are the challenges that the healthcare administrators face, and how IT services can help in solving these?The healthcare industry is being dramatically impacted by the ongoing digital revolution. From the trillions of bytes of information created by electronic health records, to the patient's desire to have ready access to that information, healthcare is rapidly moving towards a digital-first environment where personalized medicine and the empowered patient is the norm. There are certain drivers in the industry that need specific IT solutions. Mentioned below are the drivers along with the challenges faced and solutions that BMC Software offers in each: The Patient as CustomerPatients are demanding better access to their healthcare information. As a result, providers are deploying online portals that allow patients to manage appointments, securely access health records, and correspond with clinicians. Additionally, mobile apps provide ready access to a wealth of information, from hospital directions, to patient support groups, to the menu in the hospital cafeteria. The challenges faced in this is making provision development and production environments faster and also deploying digital services and applications to patients faster. BMC Software's Release Lifecycle Management provides agile application release automation that deploys application changes faster, at lower cost, and with fewer errors. Additionally, Cloud Lifecycle Management orchestrates the agile delivery and ongoing management of secure and compliant IT services across private and public clouds, as well as legacy data center infrastructures. Medical Records and Big DataBy 2020 the healthcare industry is projected to generate almost 25,000 petabytes of data.   As providers and insurers retrieve, analyze, and share information, efficiently managing big data will be critical, ultimately leading to better healthcare practices and improved patient outcomes. In this scenario, effectively managing Hadoop big data environments and simplifying batch processing becomes a challenge. BMC Software's Control-M for Hadoop simplifies and automates Hadoop application processing for faster batch-job implementation and more accurate analytics. Cost-Effective Service DeliveryHealthcare IT organizations are expected to contain costs while delivering services 24x7x365. In spite of the disruptive changes taking place, healthcare IT organizations are still expected to contain costs while delivering services that are reliable, scalable, and highly available. Optimizing resource usage without compromising care is critical. Data Management Solutions for DB2® on z/OS® enable "zero outage" availability, support new unstructured data and reduce DB2 operating costs by redefining the way organizations perform DB2 database management. Security and ComplianceAlmost half of all security breaches in 2014 occurred in healthcare. With the increasing digitization of patient and clinical information, IT departments must remain vigilant to ensure systems are in compliance with security standards and policies. It is absolutely essential that companies have compliance with mandates and prevents unauthorized access to patient data. BladeLogic Server Automation helps IT rapidly remediate known vulnerabilities, and automate compliance checks for regulatory requirements. 3. How does of BMC Software's services boost hospitals' in-house operational efficiency?BMC's Remedy Solution is one of the best tools to assist self-service, accelerate tracking and increase transparency which boosts overall efficiency of hospitals. A couple of examples can be quoted. While a customer is in the hospital, Remedy MyIT can assist the customer to locate where a particular department, ward, cafeteria or section of the hospital is. These kind of self-service tools help customers find things without any hassle and help hospitals to manage customers without appointing additional manpower. Also, we all know Incident Management can help increase operational efficiency of a hospital to a great extent. We noticed with some of our customers that people typically didn't get enough information when their tickets were created. As a result, there were a lot of email exchanges between the ticket originator and the tech support agent to capture all the relevant details. In addition, as there was no way to track tickets, sometimes they languished in the system for months. There was also no way to identify ownership of incidents and the support staff could not keep people up to date on ticket status. BMC Software's Remedyforce has eliminated all these problems. Today, when an originator creates a ticket, Remedyforce ensures that all the necessary information is filled in. It then tracks all incidents and incident owners through the entire resolution lifecycle. This helps the support staff know how long every ticket spends in the queue, who owns it and they can be kept up to date on the status. 4. How do you see role of M2M communications in the healthcare sector? Is of BMC Software leveraging this technology?M2M Communication is helping hospitals capture events through a machine which can be transmitted through a network to an application and translated into actionable steps. BMC Software's Truesight solution can monitor the availability and communication of machines which are IP (Internet Protocol) and SNMP (Simple Network Management Protocol) enabled. This helps hospitals in M2M communication which can be a great boon in the industry to get real solutions to critical problems. 5. What are the most important trends you are witnessing in the healthcare systems and how is BMC Software adjusting to them?As mentioned earlier, Healthcare industry is gradually moving towards treating patients as customers who are ever demanding and need access to their data at any given time and place. Healthcare providers are compelled to make information more accessible and interactive so that patients can take immediate action by making appointments, downloading health records or coordinating with clinicians. This involves deploying digital services and applications to patients faster. BMC Software is helping organizations deploy application changes faster with minimum error and lower costs. 6. Hospitals generate a huge amount of (patient) data, and with the help of IT, it can be analyzed to give much more insights. Do you offer healthcare analytics related services? Are healthcare administrators utilizing it? Is there any need for such services in India? We do offer services to manage data that is collected every day so that it can help insurers and doctors derive meaningful conclusions. This data in turn helps in better healthcare practices which improves outcomes for patients. We offer accurate analytics that help healthcare practitioners manage big data. Big Data and Analytics is changing the way diseases are diagnosed, monitored and treated. Healthcare administrations have started utlilizing analytics on a regular basis. We do see a need in India but the industry has not yet developed to adopt to this need. The need in India will arise only after hospitals are completely IT enabled and transformed digitally. 7. How do you think the digitization of the healthcare system will change the role of existing healthcare professionals?Digitization is definitely changing the way healthcare professionals function. Electronic Health Record (EHR) system is one of the ways which is revolutionizing their role. EHR is making information readily available and accessible to the patient as well as the physician community. Through centralized data bases, doctors can access a list of the patient's condition without having to rely on the patient's memory alone. This helps reduce preventable errors and accidental procedures. This is also helping the healthcare community to connect and find better solution to critical cases. 8. Moving on to the future, what kind of IT services will come up for the healthcare industry, and how are your future plans aligned with those?In India, we still do not treat our patients as customers. We see this as a big game changer in the Indian healthcare industry. While private players have started adopting to some of the digital services, a push from the government is required to help the healthcare industry in to the next phase of digitization. We see India moving towards this change and BMC Software as a company is poised to address this change in the industry. We have already invested in healthcare solutions and are well equipped to serve the digital transformation in the healthcare industry in India.   ]]> https://biospectrumindia.com/news/97/8648/agilent-partners-with-purehoney-technologies.html https://biospectrumindia.com/news/97/8648/agilent-partners-with-purehoney-technologies.html Thu, 03 Nov 2016 11:37:33 +0530 Agilent Technologies Inc. and PureHoney Technologies has announced a co-marketing agreement to develop new applications on the Agilent RapidFire 365 High-throughput Mass Spectrometry System. Agilent acquired the RapidFire technology when it purchased BIOCIUS Life Sciences in 2011. PureHoney Technologies is a contract research organization founded in 2014 by the original developers of RapidFire MS instrumentation. Agilent and PureHoney will work together to develop new applications for the Agilent RapidFire/MS System, and will independently create new workflows for pharma and biopharma research, as well as forensic toxicology and metabolomics analysis. "Our partnership with PureHoney Technologies will enable both companies to synergistically enhance application offerings, providing scientists with a greater range of capabilities to enhance the depth and speed of pharmaceutical research," said Monty Benefiel, Agilent vice president and general manager of the company's Mass Spectrometry Division. "Originally developed as a tool for label-free high-throughput screening over a decade ago, RapidFire/MS is now routinely used in applications ranging from ADME-Tox, proteomics, metabolomics, clinical research to in vivo functional assays," said Can Özbal, PureHoney Technologies president and CEO. "We are thrilled to be partnering with Agilent to develop the next generation of applications on this versatile platform."   The Agilent RapidFire/MS system includes drug-screening technology that provides results 10 to 100 times faster than conventional screening methods. With more than 50 peer-reviewed journal articles, RapidFire/MS is widely accepted as the benchmark platform in high-throughput mass spectrometry. This ultra-high-throughput analysis dramatically increases productivity, providing faster results.   ]]> https://biospectrumindia.com/news/97/8645/medtronic-gets-fda-approval-for-new-recaptureable-tavr-system-.html https://biospectrumindia.com/news/97/8645/medtronic-gets-fda-approval-for-new-recaptureable-tavr-system-.html Thu, 27 Oct 2016 10:31:30 +0530 Medtronic plc has announced the US Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM) Evolut(TM) R 34 mm valve-the largest sized transcatheter aortic valve replacement (TAVR) system available in the US. The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 25-30 percent of the eligible global TAVR patient population. Previously, some of these patients were unable to receive a TAVR due to the larger size of their native diseased aortic valve. The Evolut R 34mm valve is delivered through the EnVeo(TM) R Delivery Catheter System, which features an InLine Sheath. The system delivers the lowest, true delivery profile currently on the market (16 Fr equivalent, approximately 1/5 inch), which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. The Evolut R System, with its self-expanding nitinol frame, is designed to fit within the native aortic valve, using its supra-annular valve position to help achieve excellent hemodynamic performance. "Heart teams can now use the Evolut R platform to treat the broadest annulus range in the U.S. market. The approval of the 34mm valve expands the patient population that can now receive this minimally invasive treatment alternative to open heart surgery," said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic's Cardiac and Vascular Group. "We look forward to working with physicians and heart teams across the U.S. to provide this valve to the many patients who need it."The CoreValve Evolut R 34 mm valve is only approved in the United States and not approved in Europe and other countries. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.   ]]> https://biospectrumindia.com/news/97/8641/philips-india-launches-initiatives-for-prevention-of-breast-cancer.html https://biospectrumindia.com/news/97/8641/philips-india-launches-initiatives-for-prevention-of-breast-cancer.html Wed, 26 Oct 2016 13:38:37 +0530 To mark Breast Cancer Week, Philips India announced the Husband Initiated Movement against Breast Cancer (HIM) campaign to raise awareness on prevention of breast cancer by educating husbands about the need to secure their wives' health. Having reached out to over one crore people, the campaign is running in its 4th year with an aim to popularise breast self-examination and promote the benefits of early detection, by motivating husbands to encourage their wives to undergo breast self -examination. With approximately 1.4 million women being diagnosed with breast cancer and one of every two women dying from it, early detection can significantly improve survival rates. The HIM campaign, implemented across India, has a multi-pronged approach with the aim of reaching out to women across different socio economic strata. In its endeavour to build awareness around breast cancer and motivate men to encourage their wives to undergo breast self -examination, Philips has joined hands with leading oncologists, opinion leaders, survivors and care providers. The initiative also provides for preventive screening and medical help through the Asha Jyoti and Mamo van projects in select states including Punjab and Kerala. The Asha Jyoti project running for the past 3 years has screened approximately 10,000 women for Breast Cancer. In addition, Philips community centres in urban slums will also spread awareness through special sessions by doctors and Street plays. The campaign will also address the role of food and lifestyle in preventing cancer. Mr V Raja, Head of Healthcare, Philips India said that "Breast cancer is the second most common cancer among women. An increasing numbers of patients are in the 25 to 40 years of age, which is a disturbing trend. For a woman family concerns take precedence and her own health becomes the last priority. That is why we decided to involve husbands in this awareness initiative. It is our aim to reach the maximum number of women across various strata of society."   Philips has also initiated an online petition on Change.org encouraging husbands to pledge their support to their wives for breast cancer prevention. The petition can be accessed here.   ]]> https://biospectrumindia.com/interviews/97/8639/chinas-sluggish-economy-forces-us-to-augment-our-nexus-in-india-hiaso-masuda.html https://biospectrumindia.com/interviews/97/8639/chinas-sluggish-economy-forces-us-to-augment-our-nexus-in-india-hiaso-masuda.html Wed, 26 Oct 2016 12:49:16 +0530 In India, medical technology sector is scaling up to new heights and the core reason behind this steep inclination is health awareness among the denizens of the country. Indians have now become more focused on taking preventive measures to dodge illness rather than sticking to old orthodox methods. The market for home healthcare in India is projected to reach $6.2 billion by 2020 at a CAGR of 18 per cent from $3.2 billion in 2016. Many companies have forayed into the medical technology sector with their devices that can come real handy in monitoring the daily health of an individual. Walking on the similar line, Omron Healthcare has been one of the prominent players in this sector. The company that houses almost 38,000 employees globally and 2,000 employees in India, is now planning to spread its sheet across the length and breadth of the country. In an exclusive conversation with BioSpectrum's Nitin Konde, Hisao Masuda, MD, Omron Healthcare India elaborates further on the brand's expansion plans and its strategies to tackle its counterparts. Q. How home healthcare devices segment has evolved over the years in Asia?Overall, people are still following the same orthodox method of going to pharmaceutical shop when they fall sick so, still there is a big scope of spreading a simple message of "Prevention is better than cure" among them. But, I feel that young generation is changing gears and they are the one who are more keen about shifting towards preventive measures to cope up with the health related problems. Q. Since the company supplies its healthcare units in many hospitals, how the use of healthcare devices has eased the work of medical practitioners?Devices have helped the medical practitioners in many ways especially, when it comes to monitoring the progress of the patient. Our main motive is to equip the people with gadgets that can help them in diagnosing, monitoring and to keep a regular check on their health so that they don't need to visit doctors. For example, individual's blood pressure tells the exact condition of his body and if a person keeps a close check on that every day, then he doesn't need to worry about many other aspects. Many health related issues can be avoided by following a simple cycle of checking the blood pressure on daily basis. Q. How the company is planning to spread its wings across the country?Currently, our presence in India is limited to the metro cities and our recent expansion plan will focus on further penetrating the Indian market by venturing around 26 Tier II and III cities such as Agra, Delhi NCR, Bhopal , Indore etc. In order to expand our nexus, we need to revamp our distribution channel by enrolling more distributors in it. Presently, we have 16 distributors across the nation and hence, we would like to increase our arsenal by adding around 10 more distributors in that list. Apart from that, there are many gaps in our canal such as maintaining a healthy supply chain, smooth distribution of products, requirement of local warehouse facility etc., we need to pin down these issues to have a hassle free distribution tunnel. We have also planned to tie-up with some micro financing institutes to bring down the cost of our products because in India people do look for an affordable range and we will going to provide them that. Q. Globally, the healthcare devices segment is growing exponentially, how it is mapping up in Asian corridors, especially in India and China, since the company is focusing more on these two countries? On practical grounds, China has lost its sheen, mainly because of its current lethargic economic situation. The business is going down in the Mainland China and there are companies who plugged out of the market due to this sluggish economy. This also forced us to shift our radar to India which is now on our prime focus list. The company is expecting a revenue growth of 30 per cent in India by the end of this fiscal. It is mainly because we see a big fruitful market of home healthcare segment here, which is currently hovering around US $3.2 billion, and we want to capitalize of each and every opportunity that comes our way.   Q. Internationally, company has also ventured into the wearable segment so, when it is planning to launch its wearable devices in India?Recently, we do launched a wearable device called 'Mira' for the US market but, we have not yet decided to unveil it in India. Currently, Indian market is flooded by such kind of devices and many companies are putting their stakes on this segment so, there is not much of a demand. Right now, we are focusing more on the home healthcare devices in India and we would like to stick to that as of now. Q. What are the challenges you faced while installing your business in India?We faced many challenges in India especially with the tax system which is very complicated. Initially, when we floated our business, we found it hard to understand the entire tax structure. During the dispatch of goods, we need to pay separate state tax for every state and then CST followed by few others. Secondly, in India, nebulizer and Blood Pressure Monitor (BPM) are not considered as medical devices, they are termed as measurement devices. This is a big road block for us because many players are buying these devices from China in bulk, since they are available on cheap rates, and dumping them in India, putting the quality on stake. To raise this particular issue, we are communicating with Central Drugs Standard Control Organization (CDSCO) to set up a regulation on this part and soon some fruitful result will come out. However, home healthcare is one of the fastest growing markets and India is second only to China in both scale and future expectations. In India, there is limited awareness about diseases such as hypertension, asthma etc. At the same time, major chunk of the population is unaware of devices that can help in reducing high risks involved with these diseases. So our first and foremost task is to spread awareness about the preventive health measures as much as we could.   ]]> https://biospectrumindia.com/news/97/8637/ecron-acunova-completes-integration-of-syneed-medidata-.html https://biospectrumindia.com/news/97/8637/ecron-acunova-completes-integration-of-syneed-medidata-.html Tue, 25 Oct 2016 10:37:38 +0530 Syneed Medidata GmbH, with a strong focus on Non-Interventional Studies (NIS), Data Management and Statistics/SAS-Programming has successfully integrated into the full service CRO Ecron Acunova GmbH. The former Headquarters of Syneed Medidata in Konstanz, Germany remains in existence. Full service post marketing studies have been offered by Ecron Acunova teams since the company's early days for a variety of indications. Over the years, Ecron Acunova has established an in-house, dedicated team to handle all kind of requirements for this type of studies. With the addition of the group from Konstanz this team becomes much stronger. At Ecron Acunova we have a deep understanding of the different requirements between interventional studies and "real-life" NIS studies. Birgit Mund, Head of Business Development, Europe, says: "Despite the fact that EA has a long-standing reputation in conducting Phase II-IV studies, we have also seen the need for a deep understanding of the post-marketing environment and we are proud of conducting those studies by applying tailor-made solutions for classical Non-Interventional Studies, Registries, Authority Imposed PASS, Voluntary PASS, PAES, Market Surveys and Patient & Site Screenings". In NIS projects it is important to optimize the data collection and handling from the very beginning. Ecron Acunova has developed an own, fully validated EDC platform specifically for NIS studies, allowing for a very pragmatic approach when it comes to data handling activities. Our EDC system REDCAS sets aside functions often not needed for NIS such as data import, queries and randomization and focuses instead on simplicity of set up and functional aspects. The ease of use of REDCAS also helps to keep up motivation on the users' side. Anders Malm, Managing Director, says: "At Ecron Acunova we now have an even stronger team to offer to our clients when it comes to all types of late stage projects. Our experienced study teams handle local as well as international studies in the most effective way. In addition, qualified services in Data Management, SAS-Programming, Medical Writing etc. are offered from various locations in order to have the best possible solutions for our customers".       ]]> https://biospectrumindia.com/news/97/8633/prevention-is-the-need-of-an-hour.html https://biospectrumindia.com/news/97/8633/prevention-is-the-need-of-an-hour.html Mon, 24 Oct 2016 11:49:08 +0530 Omron Healthcare, globally known for home healthcare devices, celebrated its 83 anniversary. Incepted in 1933, the brand is one the international leaders in home healthcare segment. As a part of the celebration ceremony conducted in New Delhi, the company introduced some of its popular products such as blood pressure monitoring device, nebulizer, Body Composition Monitor etc., the products which have gained popularity in the Indian market. Company has already chalked out expansion plans for India and it will be soon deploying huge amount of investment to map its presence in Tier II and III cities of the country. While shedding some light on the current market scenario of India, Hiaso Masuda, MD, Omron Healthcare India stated, "Currently, the Indian healthcare market is flooded by Chinese products and it is mainly because these units are low in cost, but quality wise, they are not up to the mark. We at Omron, don't compromise on that aspect and since it is an 83 year old brand, we have make inroads into the global market by our hard-work, dedication and delivering best quality products so, we cannot afford to lose that trust which our customers have shown on us over the years." Echoing the same voice, Prakash Tiwari, Product and Marketing Manager, Omron India, opined, "Our company's aim is to make people aware about preventive health measures and their importance. In a country like India, where people try to avoid health related issues, unless it becomes a bigger problem, prevention is the need of an hour. Our home healthcare devices have been designed to cater the daily healthcare needs of the people and this will help them to live a healthy life."   ]]> https://biospectrumindia.com/news/97/8631/thermo-fisher-scientific-launches-new-incubators.html https://biospectrumindia.com/news/97/8631/thermo-fisher-scientific-launches-new-incubators.html Fri, 21 Oct 2016 10:34:32 +0530 Thermo Fisher Scientific has announced the launch of new refrigerant-free high-performance incubators. The new Thermo Scientific Heratherm refrigerated incubators provide a consistent temperature environment for incubation applications from 5 to 70 degrees centigrade, with enhanced accuracy in the range of 15 to 25 degrees. The instrument's easy-to-use interface can store up to 10 temperature protocols set by the user, with up to 10 steps in each, and includes an advanced timer function, an automatic temperature alarm and adjustable over-temperature protection. The Heratherm refrigerated incubators employ Peltier technology, which circumvents the need for a refrigerant by using a thermoelectric element to cool or heat in one module, as needed. This element leverages the Peltier effect, where an electric voltage is converted into heat difference. "With traditional incubators, laboratory staff would have to worry about regulations and the safety of the refrigerant, especially when handling or disposing of the cooling agent," said Konrad Knauss, global product manager, Thermo Fisher Scientific. "The Heratherm system removes those concerns by circumventing the need for the use of a refrigerant as the heating or cooling element." In addition to using insulation that is free of chlorofluorocarbons (CFCs) and hydrofluorocarbons (HFCs) - chemicals that are either phased out or are being phased out by the EPA to reduce the overall risk to human health and the environment - Heratherm refrigerated incubators consume very little energy. In fact, tests against predecessor compressor-cooled models show up to 84 percent energy savings, making this system an ideal solution for many labs.   The accurate Heratherm incubator comes in two sizes: a 178-liter benchtop model and a 381-liter floor model for use in a variety of applications, including microbiology/fungi/yeast studies, reagent and antibody storage, and shelf life testing.     ]]> https://biospectrumindia.com/news/97/8630/medtech-industry-disappointed-with-latest-regulations.html https://biospectrumindia.com/news/97/8630/medtech-industry-disappointed-with-latest-regulations.html Fri, 21 Oct 2016 10:32:39 +0530 Indian medical device industry is absolutely disappointed with the second draft of the medical devices regulations, which were notified by the Union health ministry on Wednesday, which apart from other irritants, will pave the way to legalize pseudo manufacturing while enabling importers and traders to pass off as manufacturers. The latest regulations are being seen by the domestic industry as yet another blow to domestic manufacturing and a fatal blow to 'Make in India' efforts in medical device sector. "We are utterly disappointed, shocked! Why are we working at cross purposes," reacted Mr Rajiv Nath, Forum Coordinator of AiMeD, the voice of domestic medical device industry. "The latest draft regulations are an assault on 'Make in India' program. The proposed regulations will legalize pseudo manufacturing, result in closure of domestic manufacturing and drive jobs out of India," Mr Nath added. Domestic medical device industry is now quite worried about the future viability of domestic manufacturing unless some of the self-inflicting clauses are not reversed or corrected. "Manufacturing in India is on the downslide and no bigger example is there than medical devices where already simple devices earlier made in India like thermometers and stethoscopes and hot water bottles have got outsourced to China. GoI is not only losing an opportunity to drive manufacturing back into India and attract investment but by distorting the definition of 'manufacturer' to be include someone who gets the medical device made by another company on his behalf will now legalize pseudo manufacturing," say Mr Nath. "Why put up factories and be subject to Indian Inspector Raj and Red Tape? Get these made on your behalf in your Indian or American Brand in China or Taiwan and still be called a manufacturer! That Chinese factory will not be inspected! This is neither going to help 'Make in India' nor the end consumers," adds Mr Nath. Medical device industry points out it is rare for an industry to seek regulations but it does not want regulations of the Inspector Raj or traditional kind. The Industry is seeking Voluntary Compliance backed by 3rd party Certification from QCI eg ICMED, (to gain Respect for India and trust for Indian Medical Devices) as an alternative method of Compliance to the Rules and waiver of Quality Management Systems Audit by CDSCO. This voluntary compliance route which is being considered by progressive State Government and was recommended by DIPP for ensuring 'Ease of Doing Business' has now been ignored. ]]> https://biospectrumindia.com/news/97/8625/ibm-quest-diagnostics-launch-watson-powered-genomic-sequencing-service-.html https://biospectrumindia.com/news/97/8625/ibm-quest-diagnostics-launch-watson-powered-genomic-sequencing-service-.html Thu, 20 Oct 2016 11:34:55 +0530 IBM Watson Health and Quest Diagnostics has announced the launch of IBM Watson Genomics from Quest Diagnostics, a new service that helps advance precision medicine by combining cognitive computing with genomic tumor sequencing. Memorial Sloan Kettering Cancer Center (MSK) will supplement Watson's corpus of scientific data with OncoKB, a precision oncology knowledge base to help inform precision treatment options for cancer patients. The launch marks the first time that Watson for Genomics has been made widely available to patients and physicians across the country. Quest Diagnostics, a leader in genomic sequencing and oncology diagnostics that serves half the nation's physicians and hospitals, extends these advanced capabilities to thousands of the country's community oncologists, who provide an estimated 70 percent of cancer care in the United States. The Broad Institute of MIT and Harvard will provide additional genome sequencing capabilities as part of the collaboration. The new service involves laboratory sequencing and analysis of a tumor's genomic makeup to help reveal mutations that can be associated with targeted therapies and clinical trials. Watson then compares those mutations against relevant medical literature, clinical studies, pharmacopeia and carefully annotated rules created by leading oncologists, including those from MSK. Watson for Genomics ingests approximately 10,000 scientific articles and 100 new clinical trials every month. "The beauty of Watson is that it can be used to dramatically scale access to knowledge and scientific insight, whether a patient is being treated in an urban academic medical center or a rural community clinic," said John Kelly III, PhD, senior vice president, IBM Research and Cognitive Solutions. "Through this collaboration with the cancer community's leading clinical and pathology experts, thousands of more patients can potentially benefit from the world's growing body of knowledge about this disease." Bolstering the corpus of data Watson uses, MSK will provide OncoKB, a database of clinical evidence that will help Watson uncover treatment options that could target the specific genetic abnormalities that are causing the growth of the cancer. Comparison of literature that may take medical experts weeks to prepare can now be completed in significantly less time.   "Precision medicine is changing the way we treat cancer and giving new hope to people living with the disease," said Jay G. Wohlgemuth, M.D., chief medical officer and senior vice president of research, development and medical, Quest Diagnostics. "However, access to genomic sequencing and tumor analysis required to determine appropriate precision medicine treatments for a patient can be a challenge. This service combines Quest's state-of-the-art tumor analysis and national access with the cognitive computing of IBM's Watson and the deep cancer treatment expertise of MSK. This is a powerful combination that we believe it will leap frog conventional genomic services as a better approach for identifying targeted oncology treatments."     ]]> https://biospectrumindia.com/news/97/8624/robotic-surgery-vattikuti-fellowship-for-7-indian-surgeons-.html https://biospectrumindia.com/news/97/8624/robotic-surgery-vattikuti-fellowship-for-7-indian-surgeons-.html Wed, 19 Oct 2016 12:07:51 +0530 Detroit headquartered Vattikuti Foundation, a non-profit focused on promoting Robotic Surgery in the India, Europe and United States, has awarded year-long fellowships to seven Indian surgeons to specialize in Robotic Surgery in the areas of Urology, Gynecology and Head and Neck surgery. The fellowships, sponsored by Vattikuti Foundation, will help the seven selected surgeons gain expertise in this emerging field as they will go through extensive training under the mentorship of eminent Robotic Surgeons in these three areas. During their fellowship, the chosen surgeons would be trained in simulation-based dry laboratory for bedside patient assistance, patient positioning and port placement skills as well as in porcine laboratories (pig labs) for practical training. It is a highly structured program developed in collaboration with the Intuitive Surgical Inc. and other partner Vattikuti Institutions. The idea behind the fellowship is to grow the pool of trained robotic surgeons in India and prepare a competent robotic surgeon at the end of the program. Vattikuti Foundation and the host institutions - New Delhi NCR's Medanta Vattikuti Institute, Escorts Fortis Institute, Rajiv Gandhi Cancer Institute; Apollo Hospital, Chennai; Amrita Institute of Medical Sciences, Kochi and Manipal Hospital, Bengaluru -- selected the seven candidates from a pool of over a hundred applicants with post graduate qualifications in surgery and a super specialization in urology, gynaecology or ENT. Vattikuti Foundation already has Uro-oncology fellows working at the Rajiv Gandhi Cancer Institute, Delhi and Kokilaben Dhirubhai Ambani Hospital, Mumbai. In all, Vattikuti Foundation, which has been promoting Robotic Surgery in the US since 1997 right from the inception of robotic surgery, has committed to 100 fellowships in India by 2020. "At the end of this rigorous training process, we expect these bright surgeons with impeccable qualifications to become accomplished Robotic Surgeons capable of handling procedures independently," says Dr. Mahendra Bhandari, CEO, Vattikuti Foundation. "The training will help Vattikuti Fellows imbibe a robust knowledge to stay at the cutting edge of technology in medicine," adds Dr. Bhandari who also serves as Director Robotic Research and Education, Vattikuti Urology Institute, Henry Ford Hospital, Detroit. The seven selected Vattikuti Fellows will begin their training in robotic surgery by working with their mentors at New Delhi's Medanta Vattikuti Institute, Escorts Fortis Institute, and Rajiv Gandhi Cancer Institute; Apollo Hospitals, Chennai; Amrita Institute of Medical Sciences, Kochi and Manipal Hospital, Bengaluru starting October 2016. Vattikuti Fellows The fellows specializing in Urology-Dr. Kalpesh Parmar, Dr. Sachin Arakere, and Dr. K. R. Seetharam Bhat will be mentored by Medanta Vattikuti Institute's Dr. N.P Gupta, Escorts Fortis Institute's Dr. Rajesh Ahlawat and at Apollo Hospital Chennai's Dr. Sivaraman Ananthkrishnan. Dr. Gaurav Desai and Dr. Sushil Kumar will specialize in Gynecological Oncology under the mentorship of Amrita Institute of Medical Sciences' Dr. Anupama Rajanbabu and Manipal Hospital's Dr. SP Somashekhar. In the field of Head and Neck Oncology Dr. Karan Gupta will be mentored by Rajiv Gandhi Cancer Institute's Dr. Surendra Dabas. Vattikuti Foundation runs a medical student engagement program where identified Vattikuti Scholars (with a post graduate degree in surgery and a super specialization) are exposed to webinars and invitation to participate in bi-annual Robotic Surgeons Council meets. Vattikuti Foundation Innovation Program Under the Vattikuti Foundation Innovation program, surgeons working at the Vattikuti Urology Institute at Henry Ford Hospital in Detroit developed several procedures such as Vattikuti Institute Radical Prostatectomy (VIP), Robotic Radical Cystectomy, Robotic Partial Nephrectomy, Robotic surgery for children and Vattikuti technique of robotic kidney transplant surgery. These techniques were developed at the Vattikuti Urology Institute, Henry Ford Hospital in collaboration with institutions in India and across the globe and have gone on to become the Gold standard for robotic urologic surgery. American surgeon Dr. Mani Menon, Director of Vattikuti Urology Institute, Henry Ford Hospital has played a stellar role in leading the development of new applications of robotic surgery. Since then the Foundation has been working with surgeons around the world to pioneer various Robotic procedures including one for kidney transplant, developed together by Indian surgeons from Hospitals in Delhi and Ahmedabad. Robotic Surgery in India: New Milestones In the last 5 years, multi-disciplinary Robotic Surgery has established its value in India with documented superior patient outcomes and efficacy. The Vattikuti Foundation has helped expand Robotic Surgery to over three dozen hospitals in a dozen Indian cities in just five years, while the number of trained robotic surgeons has crossed 200. Indian surgeons have been adapting to this new-age tool with great enthusiasm and skill. At the forthcoming Robotic Surgeons' conference organised by the Foundation to be hosted by Kokilaben Dhirubhai Ambani Hospital, Mumbai in November 2016 nearly 150 Robotic Surgeons are expected to participate and share their experiences and techniques. Robotic Surgery Benefits Robotic surgery scores over conventional surgery as it minimizes blood loss, drastically reduces the post-operative recovery time, and brings precision in executing the procedure, thus saving healthy tissue from damage. The faster healing and lower pain-levels translate to shorter hospital stays and quick return to work. It is estimated that of the 20 million surgeries performed worldwide annually less than 100,000 surgeries are performed using a Surgical Robot. Surgical Robots combine the best of science, engineering and medicine. With 4 arms, it can reach organs and areas where human fingers can't. The 3-dimensional view that can be magnified multifold, helps the surgeons achieve precision that prevents collateral damage to healthy tissue. The single most important benefit of robotic surgery is quick recovery. If the patient is back home on the third day post surgery, instead of say a ten-day recovery period that's usual in conventional surgeries, a daily wage earner can get back to productive work much earlier, while the hospital can increase the efficiency of operations. There is little to no pain, as Robotic arms enter the body via tiny incisions, healing is quicker for the patient, scarring is minimal and savings on pain management are significant. As the incidence of tongue and mouth cancers are very high in India, Head and Neck surgery for cancer at the base of the tongue can best be undertaken using the Robot, with least pain and scarring to the patient. ]]> https://biospectrumindia.com/news/97/8622/agilent-technologies-presents-early-career-professor-award-to-dr-roeland-verhaak.html https://biospectrumindia.com/news/97/8622/agilent-technologies-presents-early-career-professor-award-to-dr-roeland-verhaak.html Wed, 19 Oct 2016 10:57:40 +0530 Agilent Technologies Inc. has named Dr. Roeland G.W. Verhaak, as the winner of the company's prestigious Early Career Professor Award. Dr. Verhaak has been selected for his contributions to the implementation of transcriptomics, genomics, and big-data analysis to the classification and diagnosis of various cancer types, including acute myeloid leukemia and glioblastoma. His approach and results spearheaded the implementation of the molecular analysis of cancer. Dr. Verhaak recently joined The Jackson Laboratory (JAX) as professor and associate director of computational biology. "Dr. Verhaak is recognized internationally for the development and implementation of workflows for the analysis of big-data from transcriptomics to next generation sequencing approaches. His data-driven, unbiased analyses of cancer genomics and profound understanding of cancer biology are improving our ability to identify clinically relevant subtypes of cancer," said Jack Wenstrand, Agilent's director of university relations and external research. "Agilent is pleased to recognize Dr. Verhaak with this award and to support his important research at JAX." "We're so pleased that Dr. Verhaak has received this prestigious award in recognition of his outstanding work in advancing human health," said Dr Charles Lee, scientific director and professor at JAX Genomic Medicine. The annual Agilent Early Career Professor Award was established in 2008. Through this award, Agilent seeks to recognize the achievements of academic researchers in the early stages of their careers and to establish strong collaborative relationships with them early in their professional lives. This award underscores Agilent's commitment to furthering research through the company's products and services, financial support, and collaborative engagement by Agilent scientists and engineers. ]]> https://biospectrumindia.com/news/97/8620/quintilesims-named-cro-of-the-year-by-fs.html https://biospectrumindia.com/news/97/8620/quintilesims-named-cro-of-the-year-by-fs.html Wed, 19 Oct 2016 10:56:52 +0530 QuintilesIMS was named Asia Pacific Contract Research Organization (CRO) Company of the Year by Frost & Sullivan, a leading business research and consulting firm. The evaluation used in Frost & Sullivan's selection was conducted before Quintiles and IMS Health merged earlier this month. "The QuintilesIMS merger is another milestone in Quintiles' history of leadership and innovation," said Rhenu Bhuller, Partner, Transformational Health, Frost & Sullivan. "Biopharma and medtech companies are eager for innovative solutions to the complex challenges they face - especially for evidence supporting outcomes- and value-based care. QuintilesIMS is well-aligned to provide those solutions." The Frost & Sullivan Company of the Year Award evaluates CROs on visionary innovation and performance as well as customer impact. QuintilesIMS ranked highly in these categories, in particular for pioneering new and complex areas such as regenerative and personalized medicine. With this most recent honor, Quintiles, now QuintilesIMS, has won the F&S CRO Company of the Year award eight times in 10 years. QuintilesIMS Asia Pacific President Anand Tharmaratnam said: "This award belongs to our dedicated employees, and I believe Asia Pac will be a global leader in 21st century healthcare innovation. I'm excited about the new solutions QuintilesIMS can offer by connecting clinical to commercial to real-world patient outcomes. We are eager to lead Asia Pac's transformation to become a center for healthcare innovation."     ]]> https://biospectrumindia.com/news/97/8621/-agilent-technologies-unleashes-its-intuvo-9000-a-user-friendly-gc-system-.html https://biospectrumindia.com/news/97/8621/-agilent-technologies-unleashes-its-intuvo-9000-a-user-friendly-gc-system-.html Tue, 18 Oct 2016 13:05:25 +0530 Agilent Technologies has added one more sword of state in its arsenal. Recently, the company has divulged its new Gas Chromatography (GC) system called 'Intuvo 9000' GC solution, offering users new innovative technology that will help laboratories meet operational, scientific and financial goals. The company had conducted a global customer survey before carving its new GC. The feedback it received during the survey was analyzed to make sure that its newly designed machine overcome the challenges faced by its customer in it earlier version. Former edition of GC system had a major complain that it is very complex and highly skilled operators are required to carry out its operations. In 'Intuvo 9000', company has eliminated the aforementioned issue hence, making it an uncomplicated field to play on. However, company claims that with Intuvo Flow Technology Smart ID Keys, the Intuvo 9000 system self-identifies installed components and self-configures methods. Operations such as mid-column backflush are made routine by eliminating complex setup and extra calculators. Elaborating further on the GC, Eric Phillips, GC/MS Marketing Manager, Agilent Technologies, Wilmington, USA said, "We travelled to our global offices with questions and then again revisited them with more question, the entire exercise was conducted with a view of designing a device which is not only user friendly but also abolishes all other road blocks of the process." "We began this innovative journey by listening carefully to our customers around the world," stated Juan Aybar, Agilent Business Manager, Chromatography and Mass Spectrometry Business in EMEAI. "The Agilent Intuvo 9000 GC system provides unprecedented ease-of-use for the GC analyst, at the time lab managers/ owners will experience an impressive boost in productivity and financial outcomes that are now taken to level never seen before in the GC market." Bharat Bhardwaj, Country Manager, Agilent Technologies opined, " Agilent has been the market leader in GC for the past 50 years. With this heritage, coupled with an extensive network of industry partnerships and market experts, the brand was uniquely positioned to take another leap forward by putting this transformational technology in the hands of our customers." ]]> https://biospectrumindia.com/news/97/8619/tata-trusts-ge-healthcare-partner-to-skill-10000-youth-for-jobs-in-the-healthcare-sector.html https://biospectrumindia.com/news/97/8619/tata-trusts-ge-healthcare-partner-to-skill-10000-youth-for-jobs-in-the-healthcare-sector.html Tue, 18 Oct 2016 11:27:21 +0530 Tata Trusts and GE Healthcare has announced a partnership to train 10,000 youth in various technical areas of healthcare over a three-year period. The partnership will focus on bridging the skills gap in healthcare technical or operating staff. The announcement was made in the presence of Mr. Ratan Tata, Chairman of Tata Trusts, Terri Bresenham, President & CEO, Sustainable Healthcare Solutions, GE Healthcare and Banmali Agrawala, President and CEO, GE South Asia. GE Healthcare Education Institute (GE HCI) will design, develop and execute these courses through a mix of both classroom training and interactive training exercises. The courses will help people graduate as X-ray, Radiography, Medical equipment, Anesthesia, Operation Theatre and Cardiac Care technicians, as well as Diabetic Education counsellors. The candidates will also undergo continuous assessment and internships during the course of this program. The successful candidates, upon clearing the Healthcare Sector Skills Council (HSSC) exam shall be granted a certification from HSSC. In the next three years, 10,000 candidates will receive loan scholarships from Tata Trusts upon qualifying for the course. GE will also fund certain candidates on the basis of their eligibility. It is estimated that the current requirement for allied healthcare professionals (AHP) in India is nearly 6.5 million as against a supply of less than 300,000. As per National Skill Development Corporation, by 2018 the healthcare technician demand-supply gap in India will be 445,000 (84% shortfall). Speaking on the occasion, Mr. R, Venkataramanan, Managing Trustee, Tata Trusts said, "At Tata Trusts, making a sustainable difference to lives is the core essence of philanthropy. Tata Trusts aim to drive improvement in healthcare delivery by enabling availability of skilled and motivated healthcare personnel. We believe that this partnership with GE Healthcare will allow many bright young minds, especially women, to come forward and bridge this gap." Training and capacity building forms an integral part of Tata Trusts' interventions, given that skilled human resources within the health sector are extremely crucial and in limited supply in India. To develop and strengthen human resources, with a focus on improving the capacities and skills of organisations, Tata Trusts has enabled the setting up of virtual classrooms at Industrial Training Institutes (ITIs) across rural India, thus empowering the remotest areas with a robust technology platform to equip, educate and train their youth.   Tata Trusts' Skills and Entrepreneurship Development initiatives focus on skilling and entrepreneurship development of youth through interventions across the spectrum. The initiatives focus majorly on underprivileged youth such as school dropouts and women, with a view to skill, re-skill, and upskill them. Over the next five years, Tata Trusts will look to train 500,000 youth and promote 5,000 micro and small enterprises. Sharing her perspective, Ms. Terri Bresenham, President & CEO, Sustainable Healthcare Solutions, GE Healthcare said "We are truly privileged to have the Tata Trusts as our partner for this initiative. The partnership will leverage on the leadership that Tata Trusts have in the areas of skilling and livelihood and GE Healthcare's expertise in designing and running technical courses in Healthcare. What makes this initiative even more special is the opportunity it provides to transform individuals and families by providing livelihood opportunities to the students, particularly women. This aligns with our commitment to bring more women leaders in the healthcare space through our #WomenInGlobalHealth initiative." Globally, GE Healthcare has committed USD 1 billion in healthcare education over the next four years to train more than 2 million professionals in the healthcare technology space. In India, GE Healthcare Education Institute runs its healthcare skill building and skill enhancement program - "Yogya Bharat for an Aarogya Bharat" which aims to improve access to quality healthcare throughout the country by developing skilled healthcare resources. GE HCI provides accredited skill building courses for 12th standard pass students and skill enhancement programs for existing healthcare professionals. Over 5500 people have been trained till date. The Institute today has 10 centers across India and delivers 39 different courses through six skilling partners. In order to enhance reach of its programs, GEHCI recently started offering these courses online through its portal: https://hci.gehealthcare.com   ]]> https://biospectrumindia.com/news/97/8615/medtech-sector-urges-govt-to-expedite-regulatory-reforms-for-the-sector.html https://biospectrumindia.com/news/97/8615/medtech-sector-urges-govt-to-expedite-regulatory-reforms-for-the-sector.html Mon, 17 Oct 2016 11:06:59 +0530 AiMeD, the apex body of Indian medical device manufacturers, has urged the Ministry of Health and Family Welfare for speedy implementation of the decision taken three months ago by the Prime Minister's Office to initiate wide ranging regulatory reforms for medical device sector in order to boost domestic manufacturing and investment in the sector as well as to ensure enhanced healthcare security for common Indian citizens. PMO has specifically deliberated on the need to bring a new legislation for medical device industry as well other regulatory reforms including the need to delink medical device sector from the pharmaceutical industry. Currently, the medical devices sector is governed by the Drugs and Cosmetics Act, 1940, the same Act which also governs pharmaceutical sector in the country, an absurd legacy which has been impeding the growth of and investment in medical device sector. However, despite three months of having elapsed since the PMO's decision to speed up regulatory reforms, there appears to be little movement on its directives. "We are extremely thankful to the Prime Minister's office for recognizing the need to speed up regulatory reforms for the medical device industry. Early implementation of PMO's directives is in the interest of the country, enhanced healthcare security for millions of Indians and for boosting domestic manufacturing and investment in medical device sector," said Mr Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Manufacturers (AiMeD). Reforms are also needed to lower the huge burden of import dependency in this critical sector, added Mr Nath.   To boost domestic manufacturing and investment, increase productivity and to minimize import dependency in this critical healthcare sector, the medical device industry has been specifically urging:(i) A separate Medical Device Regulatory Act and separate Rules rather than ongoing amendment to D&C Act, 1940.(ii) A separate department for Medical Devices to act as facilitator and regulator for medical devices.(iii) Strict ethical marketing regime code and disincentivization of such importers who are passing over as manufacturers by just labeling imported products."AiMeD urges MOH&FW for early implement decisions taken three months ago at the PMO on bringing in Regulatory Reforms and table the Bill on regulating all medical devices on ASAP basis. This is not only in the interest of patient safety but also to give clarity to confused apprehensive investors who are today reluctant to invest in this huge sector. We cannot move from move from 70% import dependency to self sufficiency and unleash the huge export potential appropriate regulatory reforms are undertaken urgently," pointed out Mr Nath. It may be noted that nowhere in the world, the pharmaceutical and medical device sector are governed by the same set of legislations as has been historically done in India. By strange quirk of wisdom, the Indian medical device sector which has very different R&D, technologies, investment, production and taxation requirements from pharmaceutical sector has continued to be governed by Drugs and Cosmetics Act, 1940! While this situation led to significant growth of the Indian pharma sector, it has had exactly opposite and detrimental impact on medical device sector - leading to its near demise in recent past but for some determined and brave efforts made by some members of AiMeD to keep the sector floating. This paradoxical situation also contributed to making India overwhelmingly import dependent and scaring away domestic and foreign investment. Currently country's overall import dependency in medical devices is around 70% while in electronic medical devices it is over 90%. To rectify the situation, AIMED has been seeking a new regulatory regime including changes in drug rules covering regulatory quality management framework. To rectify the situation, AiMeD has been persistently seeking a new regulatory regime including changes in drug rules covering regulatory quality management framework but it's been a struggle for the last decade as there has been little enlightened thinking in the interest of boosting domestic manufacturing and reducing huge import dependency. But with new government in place and with its firm commitment on 'Make in India' vision, the medical device industry has been hopeful of speedy reforms unleashing the potential of this sector which will not only lower the cost of healthcare but also generate huge quality employment. The problem for domestic manufacturers has been aggravated by pseudo manufacturers who are basically importers and are passing off themselves as manufacturer by simply labeling imported products. AiMeD wants a clearer definition and clear distinction between manufacturers and traders. "It may sound little strange that our industry is demanding regulations but this is not regulations of the Inspector Raj or traditional Pharma kind. We are seeking 'Voluntary Demonstration of Compliance via 3rd Party Certification' e.g. ICMED Certification to gain Respect for India and trust for Indian Medical Devices and Risk Proportionate Penal controls for this engineering industry," said Mr Nath. Medical device industry is now hoping that MoH&FW will speedily push the PMO's agenda of enhanced Patient Safety and Make in India and adhere to defined timelines for tabling the Bill to regulate quality of Medical Devices by this winter session itself.   ]]> https://biospectrumindia.com/news/97/8597/3m-launches-worlds-first-tablet-based-mobile-intraoral-scanner-.html https://biospectrumindia.com/news/97/8597/3m-launches-worlds-first-tablet-based-mobile-intraoral-scanner-.html Wed, 12 Oct 2016 11:11:50 +0530 Mobile tablets, commonplace in many aspects of clinical practice in health care settings, have arrived in the dental industry with the introduction of the 3M Mobile True Definition Scanner, a one-of-a-kind tablet-based intraoral scanner that fits in your hand. The compact, ergonomic design is similar to rechargeable tablets that patients and clinicians use in their daily lives, allowing clinicians to move freely between operatories without power cords or carts. Flexible mounting options help to minimize workspace clutter, offering more space for the clinician and assistant to maneuver in small spaces. Informed discussion and visual patient communication is made easy with a system that can be placed directly into the hands or lap of a patient, where they can experience a cutting-edge digital visualization of their oral anatomy, and ultimately, a better understanding of proposed treatments. With easy setup - users can unbox and scan in less than an hour - the 3M Mobile True Definition Scanner can seamlessly integrate into the practice. "The 3M Mobile True Definition Scanner takes the patient experience to another level," said Karen Burquest, digital oral care global business director at 3M Oral Care. "This scanner offers clinicians the flexibility to place the tablet in the patient's hands so they can experience unprecedented access, while the clinician educates them about the treatment process. Because the tablet is compact and operates on battery, clinicians can easily hand carry the scanner between operatories. This scanner will impact the landscape of digital dentistry." Developed with the tradition of 3M science in mind, this new scanner is designed to deliver convenience for practitioners, as well as a memorable visual experience for the patient. "At 3M Oral Care, we are committed to inventing new products and processes that will positively impact a patients' oral health for years to come," concluded Burquest. Restorations created from scans are proven to be accurate - and more consistently accurate - than other leading intraoral scanners, with a 99.7 percent fit rate.1 This paired with the smallest wand on the market means scanning with this system is not only comfortable for clinician and patient alike, it delivers precision clinicians can trust. With a low-price entry into digital impressioning at just $16,995, this new mobile scanner fits the size, mobility, practice requirements and budget needs of practitioners. The decision to adopt digital scanning just got a little easier.   ]]> https://biospectrumindia.com/news/97/8601/agilent-introduces-new-innovative-laboratory-solutions-.html https://biospectrumindia.com/news/97/8601/agilent-introduces-new-innovative-laboratory-solutions-.html Wed, 12 Oct 2016 11:10:38 +0530 Agilent Technologies Inc. will showcase its latest innovations at analytica China 2016, the leading Chinese exhibition for laboratory technology, analysis, biotechnology and diagnostics, in Shanghai, Oct. 10-12, 2016. These innovations are industry-leading and are designed to meet the specific needs of the markets Agilent serves, including China. "We innovate with a purpose-our solutions are designed to improve the science and the economics of the laboratory," said Patrick Kaltenbach, president of Agilent's Life Sciences and Applied Markets Group. "For example, our instruments are built with the industry's top technology, yet designed for ease of use and efficiency, and our software unifies the lab with multi-technique, and multi-vendor capabilities. With every innovation, Agilent's goal is to deliver the trusted answers and insights customers need to realize superior outcomes." Featured Agilent innovation excels customers' operational excellence: The recently introduced Agilent Intuvo 9000 GC System will be a feature at analytica China 2016. This innovative solution makes sophisticated gas chromatography (GC) technology easy to use with click-and-run connections that eliminate ferrules, Guard-Chip technology that extends column life, and a trim-free column that eliminates retention time shifts due to column trimming maintenance. The Intuvo 9000 is ideal for high-throughput contract laboratories, and for labs dealing with difficult sample matrices, in fields such as food, environment, chemical and forensics testing. Customers throughout the world, including China, anticipated these types of operational advancements, and Agilent delivered. With a 50-year history in GC, Agilent is the market leader; and China is the home of the company's largest GC production line. Additional Agilent solutions on display that deliver operational excellence include: • The Agilent 4210 Microwave Plasma-Atomic Emission (MP-AES) Spectrometer, which enables remote elemental analysis. This flexibility opens up new possibilities for applications such as on-site process stream monitoring, as well as river-water and source-water monitoring-one of the key focus areas of China's 13th Five-Year Plan. • The latest version of Agilent OpenLAB Chromatography Data System (CDS) Software, which makes complex data analysis simpler, and enables laboratories to manage their entire workflow on a single screen. With advances such as Peak Explorer, additional insights into data sets are revealed that help customers reach critical decisions faster. • Agilent AdvanceBio Size Exclusion Chromatography (SEC) Columns, which deliver excellent peak shape to help biopharma companies achieve reproducible results when analyzing monoclonal antibodies.   Another highlight of analytica China 2016 will be next-generation sequencing. Agilent solutions presented will include sample quality control and automated library preparation. NGS has revolutionized variant analysis by providing single-molecule sensitivity, enabling the detection of rare alleles and those of low frequency, even within highly heterogeneous samples. Innovations that enhance laboratory efficiency: Agilent will also demonstrate solutions that improve laboratory efficiency through high performance, reliability and robustness: • The Agilent 1260 Infinity II Liquid Chromatography (LC) System, which provides easy column handling and superior sample logistics to ensure fast turnaround times and high instrument utilization. • The Agilent 5110 Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) System that incorporates unique Dichroic Spectral Combiner (DSC) technology, enabling axial and radial view analysis at the same time. • The second-generation Agilent 8900 Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) System with controlled-reaction chemistry that delivers the lowest detection limits for previously difficult elements such as sulfur, silicon and phosphorus. This system also includes a fast detector that sets a new benchmark for single nanoparticle applications. • The Agilent 7010B Triple Quadrupole Gas Chromatography/Mass Spectrometry System that enhances efficiency with the inclusion of Agilent's patented JetClean self-cleaning ion source. JetClean significantly reduces-or even eliminates-the need for source cleaning. • Agilent will also showcase a new application kit that enables food-testing laboratories to quickly screen for 189 veterinary drugs regulated by the Chinese Ministry of Agriculture. Additionally, Agilent continues to provide diversified services that improve the digital experience for customers. Recent enhancements include a new China online store that will enable easier purchasing, as well as new online services and learning functionality via WeChat and App. Representatives from the Agilent CrossLab Group will participate in analytica China 2016 to discuss the full range of Agilent's laboratory solutions, including Laboratory Business Intelligence, Laboratory Equipment Management, RFID for Inventory Management and more. "Today, we are even more focused on our customers," said Mark Doak, president of Agilent CrossLab Group. "We're partnering with customers to better understand their laboratory and workflow needs, develop and design customized solutions, and deliver differentiated consumables, services and consultative support. We believe these investments in China will enable our customers to achieve better economic, operational and scientific outcomes."   ]]> https://biospectrumindia.com/news/97/8595/regulatory-aspects-of-analytical-instrumentation-is-the-focus-of-analytica-anacon-india2016.html https://biospectrumindia.com/news/97/8595/regulatory-aspects-of-analytical-instrumentation-is-the-focus-of-analytica-anacon-india2016.html Fri, 07 Oct 2016 17:46:47 +0530 'Regulatory aspects of Pharmaceutical Laboratories', 'Biopharmaceuticals and Bioanalysis', 'Food Safety' or 'Clinical Diagnosis' are the main topics of the 2016 edition of the analytica Anacon India and India Lab Expo conference. The speakers, eminent scientists and industry representatives, come from both - India and overseas. The program is rounded out by tutorials in all four sessions where practical application tips are passed on the audience. Among this year's speakers are (in alphabetical order):Dr. Laxmikant Gandikota (Biological Evans), Dr. Ashes Ganguly (Indian Analytical Instruments Association),Prof. Dr. Myeong Hee Moon (Yonsei University),Prof. Dr. Michael Hilderbrand (University of Jena), Prof. Dr. Dietmar Knopp (Technical University of Munich), Prof. Dr. Rainer Lehmann (University of Tuebingen), Dr. Eike Reich (CAMAG), Dr. Pia Rosendahl (ISAS), Prof. Dr. Michael Rychlik (Technical University of Munich), Prof. Oliver Schmitz (University of Duisburg-Essen), Arjan Timmerman (Waters Corporation)and Dr. S. P. Vasireddi (Vimta Labs). Bhupinder Singh, CEO of Messe München India, says: "The conference will bring together leaders of this field to share a comprehensive overview of this rapidly expanding industry with the prime objective of knowledge transfer. Over 250 delegates will participate at the conference who will have the opportunity to interact with well-known scientists around the world. Participants can be sure of picking up important concepts, which will be very useful in the days to come." The organizers expect more than 350 exhibitors and 8,500 visitorsto analytica Anacon India and India Lab Expo. Both trade fairs have been growing in stature as one of the most influential pit-stops in the Indian Annual Trade Fair calendar. The two events bring together companies with similar product lines and business interests, apart from bringing the buyer and seller community on one common platform. The conference and various further forums will transmit additional momentum and background information on the various topics being deliberated at the trade fairs.   ]]> https://biospectrumindia.com/news/97/8596/voxtur-bio-enters-in-vitro-diagnostic-test-kits-market.html https://biospectrumindia.com/news/97/8596/voxtur-bio-enters-in-vitro-diagnostic-test-kits-market.html Fri, 07 Oct 2016 16:52:23 +0530 Mumbai-based Voxtur Bio Ltd has entered the fast-growing domestic diagnostic market by launching a wide range of in-vitro diagnostic kits and reagents. Voxture Bio, set up by young entrepreneur Viral Gandhi, was commercially commissioned in April this year and has already launched nearly 100 products in different categories of the in-vitro kit manufacturing sector dominated by just a handful of players in India. Voxtur's product portfolio covers the range of rapid testing kits for infectious diseases like HIV, HCV, HBsAg and Syphilis, along with rapid tests for seasonal diseases like Malaria, Dengue, Typhoid and Leptospira. In addition to the initial product portfolio, it has now focused on the OTC segment with hCG pregnancy testing kits, both under normal device format and mid-stream format. It also launched the entire range of Blood Grouping agglutination Sera, along with all the flocculation tests for Rheumatology. Khushroo A. Pastakia, CEO & Executive Director, Voxtur Bio Ltd, said that currently the firm is working on the ELISA range for all the prominent infectious diseases and has also set up a huge infrastructure for manufacturing of blood collection tubes. "In the initial phase, the company ventured into Hematology and Immunology, two of the four major segments of clinical diagnostics. The product portfolio under our stable includes Rapid Test kits, ELISA Test kits, Blood Grouping sera and other Flocculation tests to begin with. Later on, the company will be venturing into the other two remaining segments: biochemistry and microbiology, apart from highly automated clinical laboratory analysers in the clinical chemistry and haematology arena," Khushroo said. The company has put in place an active marketing plan for the domestic market and will be deploying its sales team of 100 members, positioned in simple two-tier structure. "We will be setting up our distribution channel by partnering with various stockists across India. There are around 300 small and big cities in India, amongst which we have shortlisted 100 big ones that need to be targeted during the first year, with an increase in count year after year. Gradually we may opt for a C&F/super-stockiest sort of business model for each state," he added. Sensing the potential in the market and the gap in supply, Viral Gandhi, the Chairman and the Managing Director of the company, started the work on the project a couple of years back. "One challenge was to source the right pool of talent which is technically sound, skilled and qualified, followed by shortlisting of the "top of line" products that can move in the IVD market, with ease and deliver the desired results," said Viral. ]]> https://biospectrumindia.com/news/97/8594/parexel-launches-tracking-service-for-medicinal-products-.html https://biospectrumindia.com/news/97/8594/parexel-launches-tracking-service-for-medicinal-products-.html Fri, 07 Oct 2016 11:08:00 +0530 PAREXEL International Corporation has announced the launch of its Active Tracking service. The service follows Good Distribution Practice (GDP) requirements by providing biopharmaceutical companies with near real-time temperature and location monitoring of investigational medicinal products (IMPs) from central distribution centers to clinical trial sites. An increasing number of medicinal products require a temperature-controlled supply chain to maintain product integrity during transport, including approximately 75 percent of biological drugs, 10 to 15 percent of small molecule therapies, 100 percent of vaccines, and a large percent of biologic samples and diagnostic tools. Temperature deviations and shipment delays can impact patient safety, create patient retention issues, and cause additional manufacturing and shipment costs. Supported by PAREXEL's Clinical Trial Supply & Logistics global depot and service network, PAREXEL's Active Tracking service utilizes supply chain monitoring technology to detect incidents, such as shipment delays, shipment diversions, and temperature deviations. When combined with PAREXEL ClinPhone RTSM interactive response technology (IRT), temperature and location data is automatically sent in near real-time to clinical trial sites for assessment. This integration enables greater automated preventive or remedial actions, such as release, quarantine, and automatic re-order of temperature-controlled products, simplifying temperature management for sites and sponsors. "In the past, an investigational site had to wait until it received a shipment and downloaded the data from the temperature logger to find out if a drug's temperature had been compromised," said Sanjay Vyas, Corporate Vice President, Clinical Trial Supplies & Logistics, PAREXEL. "With PAREXEL's Active Tracking service, we can monitor IMPs from packaging at our depots through transit to clinical trial sites, in near real-time. This innovation in clinical supply chain management allows us to quickly respond to any temperature complications, which can reduce safety risks for patients as well as manufacturing and shipment costs for clients."   ]]> https://biospectrumindia.com/news/97/8593/foldscope-fame-manu-prakash-receives-macarthur-genius-grant.html https://biospectrumindia.com/news/97/8593/foldscope-fame-manu-prakash-receives-macarthur-genius-grant.html Thu, 06 Oct 2016 11:43:00 +0530   Assistant professor of bioengineering at Stanford Manu Prakash received the MacArthur "Genius Grant" on Sept. 21 as one of 23 recipients. The grant is awarded annually to residents or citizens of the United States who have shown "extraordinary originality and dedication in their creative pursuits and a marked capacity for self-direction," according to the MacArthur Foundation. It consists of a total of $625,000 paid over five years, and the recipients of the grant have no particular obligations other than to continue their activities. Individuals are nominated for the award. Manu Prakash is a physical biologist applying his expertise in soft-matter physics to illuminate often easy to observe but hard to explain phenomena in biological and physical contexts and to invent solutions to difficult problems in global health, science education, and ecological surveillance. His many lines of research are driven by curiosity about the diversity of life forms on our planet and how they work, empathy for problems in resource-poor settings, and a deep interest in democratizing the experience and joy of science globally. Prakash's projects range from explorations of how shorebirds drink to how a few drops of food coloring can demonstrate highly complex behavior such as chemotaxis, akin to active living matter. His early training and research focused on ideas of physical computation, with a goal of building new computational engines capable of manipulating not just bits of information but also physical matter. One such demonstration involved building a computer out of tiny air bubbles traveling in microfluidic channels. In recent work, Prakash demonstrated a practical implementation of this "water computer," or microfluidic processor, with potential applications in diagnostics and environmental monitoring.   More recently, Prakash has channeled his ingenuity to invent several devices that empower frugal science: these are low-cost, widely accessible, and appropriate for use in low-resource and field settings. Foldscope, a lightweight optical microscope that costs less than a dollar to produce, is assembled from an origami-based folding design from a single sheet of paper with integrated lenses and electronics. With submicron resolution, Foldscope has already been widely embraced in educational contexts. Prakash has enlisted thousands of volunteers-from medical experts to citizen scientists-to field test Foldscope as he works to refine it for use in public health and biomedical settings. Another recent project is a low-cost, sticker-like microfluidic chip that can collect thousands of nanoliter-volume droplets of saliva from mosquito bites that can be screened for pathogens. The chip would enable rapid, scalable, and low-cost collection of surveillance data that is critical for predicting and controlling mosquito-borne disease outbreaks. With remarkable breadth and imagination, Prakash defies traditional disciplinary boundaries in his coupling of basic research and fabrication of high-capability scientific instruments for widespread use in the field and classroom. Manu Prakash received a B.Tech. (2002) from the Indian Institute of Technology Kanpur and a Ph.D. (2008) from the Massachusetts Institute of Technology. He was a junior fellow of the Harvard Society of Fellows (2008­-2011) prior to joining the faculty of Stanford University, where he is currently an assistant professor in the Department of Bioengineering, a member of the Biophysics Program in the School of Medicine and the Center for Innovation in Global Health, Faculty Fellow of Stanford ChEM-H, and an affiliate member of the Woods Institute for the Environment. He holds numerous patents and his research has been published in such scientific journals as PLoS One, Journal of Experimental Biology, Science, and Nature, among others. ]]> https://biospectrumindia.com/news/97/8519/uptake-medical-is-now-part-of-broncus-medical.html https://biospectrumindia.com/news/97/8519/uptake-medical-is-now-part-of-broncus-medical.html Thu, 06 Oct 2016 11:08:32 +0530 Broncus Holding Company (BHC), announced that it has acquired the assets of privately held Uptake Medical Corp, the manufacturer of vapor technology for the bronchoscopic ablation of emphysema and lung cancer. Vapor ablation has been shown to result in clinically meaningful improvement in lung function and quality of life in a recent randomized controlled trial published in the Lancet RM (July 2016). The acquisition positions BHC as the leader in providing the complete solution for the two most devastating lung diseases. BHC's Chairman Michael Zhao explains: "Our plan is to deliver a solution through combination of the technologies from our two companies, Broncus Medical Inc. and Uptake Medical Technology Inc. Broncus Medical Inc. will focus on the complete treatment for Lung cancer and Uptake MedicalTtechnology will focus on the complete treatment for emphysema. Together these two companies represent complete answers for the number one and two leading causes of pulmonary disease." "We are very excited to be able to offer an impeccable solution to bronchoscopic-based lung cancer treatment through the integration of Uptake's vapor technology and our products, LungPoint and Archimedes", said Henky Wibowo, President of, Broncus Medical Inc., San Jose, CA. "We are elated to have the additional resources and infrastructures that Broncus provides to rapidly extend our commercialization coverage in the EU and Asia. Additionally, Broncus' products will complement and extend the InterVapor system and further simplify the procedure for treating emphysema patients." said Robert Barry, President of Uptake Medical Technology, Seattle, WA.   ]]> https://biospectrumindia.com/news/97/8590/quintiles-is-now-quintilesims.html https://biospectrumindia.com/news/97/8590/quintiles-is-now-quintilesims.html Wed, 05 Oct 2016 12:07:22 +0530 Quintiles IMS Holdings, Inc. announced that it has successfully completed its merger of equals transaction between IMS Health Holdings, Inc. (and Quintiles Transnational Holdings Inc. The merger of IMS Health, a leading global information and technology services company, and Quintiles, the world's largest provider of product development and integrated healthcare services, creates a leading information and tech-enabled healthcare service provider with global scale and reach, and a full suite of end-to-end clinical and commercial offerings. IMS Health merged into Quintiles with Quintiles as the surviving company renamed Quintiles IMS Holdings, Inc. and known as QuintilesIMS. Shares of IMS Health were halted from trading today on the NYSE and will no longer be traded. Under the terms of the merger agreement, at the effective time of the merger, each share of IMS Health was automatically converted into 0.3840 of a share of Quintiles stock.   ]]> https://biospectrumindia.com/news/97/8589/siemens-stride-coagulation-analyzer-receives-fda-clearance-.html https://biospectrumindia.com/news/97/8589/siemens-stride-coagulation-analyzer-receives-fda-clearance-.html Wed, 05 Oct 2016 12:07:01 +0530 Siemens Healthineers announced FDA 510(k) clearance for a hand-held portable coagulation analyzer. The Xprecia Stride Coagulation Analyzer delivers fast, reliable Prothrombin Time International Normalized Ratio (PT/INR) testing for point-of-care monitoring and management of oral anticoagulation therapy with warfarin, a vitamin K antagonist. Millions of PT/INR tests are administered world-wide each year as part of therapy monitoring for patients with a host of conditions, including atrial fibrillation, heart valve replacement surgery, deep vein thrombosis and congenital heart defects, among others. The Xprecia Stride Coagulation Analyzer was specifically designed to meet the growing demand for fast and reliable PT/INR results in physician offices and walk-in clinics to help healthcare professionals make informed decisions about patient care. Winner of multiple international design awards such as the Red Dot Award: Product Design for 2015 and the iFDesign Award, the analyzer includes a number of innovations and features not found on most other point-of-care analyzers. No bigger than a smartphone and weighing just 10.5 oz, the Xprecia Stride Coagulation Analyzer can be held at virtually any angle and brought directly to the patient's finger for efficient and comfortable blood sample application. "Among the many challenges of point of care testing, accuracy and safety have become paramount to both the user and patient. With the Xprecia Stride analyzer, Siemens Healthineers delivers on the promise to bring a safe and lab-accurate test directly to the patient," said Michael Sampson, Senior Vice President, Point of Care, Siemens Healthineers, North America. "The Xprecia Stride analyzer is designed to be safe, efficient and ergonomically friendly. By adding the Xprecia Stride analyzer to our existing product portfolio in the U.S., we now have the ability to cover the full range of hemostasis testing from the hospital lab to the physician's office." Today's busy healthcare professional is challenged by a complex work environment and heavy patient workflow. The Xprecia Stride analyzer was designed to address these concerns through an intuitive user interface and features such as an integrated barcode scanner to simplify data capture and improve patient workflow. To further enhance usability, the Xprecia Stride features simple icons and animation in a color display more commonly found in mobile devices than medical instruments.   The Xprecia Stride analyzer uses fresh capillary (fingerstick) whole blood and results are expressed as INR. It utilizes the same Dade® Innovin® reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability. Studies have shown the performance to be equivalent to a reference laboratory hemostasis system,1 with results available within minutes. Safety features include a first-of-its kind test strip eject button that allows the user to eject a used test strip and easily dispose of it without touching it, minimizing potential biohazard exposure. When taken together, all of these innovations ultimately enable better patient care as point-of-care PT/INR testing becomes critical to healthcare providers managing the growing number of patients that require anticoagulation therapy.   ]]> https://biospectrumindia.com/news/97/8592/medgenome-inks-deal-to-sequence-genome-of-1-lakh-asians.html https://biospectrumindia.com/news/97/8592/medgenome-inks-deal-to-sequence-genome-of-1-lakh-asians.html Tue, 04 Oct 2016 17:26:00 +0530 MedGenome Labs has inked a pact with with South Korean biotech firm Macrogen Inc. and Singapore-based Nanyang Technological University (NTU) to sequence the whole genome of 1,00,000 people in Asia. Through the deal the institutions aim to build an open genome data base accessible to researchers of public institutions and pharmaceutical companies. The sequencing will cover populations of 14 Asian countries in South Asia, South-East Asia and East Asia. MedGenome offers genomics-based diagnostic solutions to hospitals and doctors as well as genomic research services to pharmaceutical and biotech companies and academic research institutions in India. The company offers more than 100 tests currently across oncology, cardiology, ophthalmology, neurology and nephrology. The company also developed India's first non-invasive prenatal test this year. As per the terms, Medgenome will invest $10 million as part of its commitment in a project estimated to cost upwards of $120 million. Macrogen and NTU will contribute $10 million each. The consortium is in the process of raising the remaining funds through contributions from academic institutions, hospitals and pharmaceutical companies. The project is proposed to be accomplished in stages. The first stage of the project called 'GenomeAsia100K' aims to sequence 10,000 Asian individuals for ethnic stratification, followed by sequencing an additional 90,000 individuals and combined with clinical and phenotype information to allow deeper analysis of diseased and healthy individuals, Medgenome said. Mr Sam Santhosh, chief executive officer at MedGenome, said, "The current genomic data available is largely of Caucasians, though Asia represent 40 percent of the world's population - they are significantly underrepresented in current genomic studies and reference genome databases. The unique genetic diversity prevalent in South and East Asia provides a valuable source of clinical insights to enable cures for all of mankind in rare and inherited diseases, as well as complex diseases such as cancer, diabetes and neurological disorders." Medgenome plans to use the a latest next generation gene sequencing machine procured from California-based Illumina Inc. at an estimated cost of $12 million, extensively in the project. "The latest machine will help to sequence human genome at cost of $1000," Mr Santhosh said. ]]> https://biospectrumindia.com/news/97/8584/agilent-burning-rock-partner-on-molecular-diagnostics-.html https://biospectrumindia.com/news/97/8584/agilent-burning-rock-partner-on-molecular-diagnostics-.html Mon, 03 Oct 2016 11:18:44 +0530 Agilent Technologies Inc and Burning Rock have signed an agreement under which Burning Rock will develop cancer diagnostics in China based on the Agilent SureSelect target enrichment system. Agilent is the leading provider of target enrichment for next-generation DNA sequencing. Target enrichment saves researchers time and resources by enabling them to focus on regions of interest rather than looking at the entire genome. Burning Rock is a fast-growing company focused on developing cancer diagnostics based on DNA sequencing. "As the leader in molecular cancer diagnosis in China, Burning Rock is very pleased to partner with Agilent, a global leader in diagnostics and genomics," said Yusheng Han, the founder and chief executive officer of Burning Rock. "Collaboration between our two companies will provide additional high-quality molecular diagnostic solutions based on next-generation sequencing, including non-invasive testing, relapse monitoring, early-stage diagnosis and cancer susceptibility." Fast and accurate cancer diagnoses are becoming increasingly important in China, with its extensive population and growing focus on advancing human health. "We are excited to partner with Burning Rock to accelerate accurate diagnosis of cancer for patients in China," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "We believe that target enrichment and next-generation sequencing have a vital role to play in personalizing medicine and ultimately delivering treatments tailored to the individual. This is especially so for complex diseases such as cancer."   Burning Rock plans to register its molecular diagnostic kit with the China Food and Drug Administration. The company believes the kit could become the first CFDA-approved capture sequencing-based cancer diagnostic assay in the Chinese market.   ]]> https://biospectrumindia.com/news/97/8582/fda-nod-for-medtronics-trailblazer-angled-peripheral-support-catheter.html https://biospectrumindia.com/news/97/8582/fda-nod-for-medtronics-trailblazer-angled-peripheral-support-catheter.html Fri, 30 Sep 2016 11:47:56 +0530 Medtronic plc announced that the U.S. Food and Drug Administration (FDA) has cleared the TrailBlazer(TM) angled support catheter for use in the peripheral vascular system. Support catheters such as the Trailblazer are often used in endovascular procedures treating complex peripheral artery disease (PAD). FDA clearance was received on September 23, 2016. The new TrailBlazer angled support catheter is designed to support a guide wire during access to the peripheral arteries, and to enable delivery of solutions and diagnostic agents. The catheter features a braided stainless steel shaft for robust pushability and a 25 and 30 degree angled tapered tip to access and cross complex lesions. To enhance physician visibility, each of the .014", .018" and .035" guidewire compatible devices is designed with three radiopaque marker bands and a radiopaque shaft. Additionally, both the .014" and .018" TrailBlazer angled support catheter can fit coaxially through the .035" support catheter for increased reach and pushability. "Medtronic is committed to providing physicians with meaningful innovations and therapy choices to enhance their peripheral treatment algorithm," said Mark Pacyna, vice president and general manager of the Peripheral business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "Working with physicians, we have extended the Medtronic TrailBlazer support catheter portfolio to offer a broad suite of angled options for treatment of complex lesions both above and below the knee."     ]]> https://biospectrumindia.com/news/97/8581/sandoz-invites-young-entrepreneurs-to-enter-sandoz-hack-.html https://biospectrumindia.com/news/97/8581/sandoz-invites-young-entrepreneurs-to-enter-sandoz-hack-.html Thu, 29 Sep 2016 15:45:14 +0530 Sandoz, the Novartis generic and biosimilar pharmaceutical division, announces the launch of Sandoz HACk - Healthcare Access Challenge - a global competition to generate innovative ideas and solutions to help tackle some of the world's most pressing healthcare access problems. The competition is open for entries until November 30, 2016. "There are numerous challenges that impact healthcare in a country like India and we need to collaborate with all stakeholders to improve health access," said Jawed Zia, Country President, Novartis India. "The launch of Sandoz HACk is one of the ways we want to identify and then foster creative ideas from countries like India." Despite the significant advances made in modern medicine, more than two billion people worldwide cannot access the medicines they need and more than 400 million lack access to essential health services.1 The combined efforts of stakeholders across both public and private sectors, including the pharmaceutical industry, not-for-profit organizations and governments have made significant advances in tackling healthcare access challenges worldwide. But these large scale systemic initiatives need to be supported by community-led change, driven by innovative small scale solutions that can make a big difference. Therefore, Sandoz HACk has been launched, inviting people to generate novel solutions to tackle key healthcare access challenges in local communities. Mobile technology is radically altering how care is delivered and received worldwide and the influence of mobile in healthcare is likely to continue evolving in the future. In its inaugural year, Sandoz HACk encourages today's generation of entrepreneurs and creative thinkers to enter ideas that harness mobile health technologies - M-Health - to help solve relevant local healthcare access challenges. Sandoz HACk is open for entries from 18-35 year olds around the world. Following a robust judging process, the six finalist entries will be published on OpenIDEO - a global community of leading organizations and individuals working together to design solutions to the world's biggest challenges. Entrants' ideas will be refined and evolved in partnership with this online community before being presented to a panel of judges. Three winners will be chosen and awarded seed funding and mentorship to help bring their ideas to life.   For details, please visit: www.sandoz.com/makingaccesshappen and www.facebook.com/sandozglobal       ]]> https://biospectrumindia.com/news/97/8579/the-pfizer-iit-delhi-innovation-and-ip-program-announces-first-round-of-grant-awardees-.html https://biospectrumindia.com/news/97/8579/the-pfizer-iit-delhi-innovation-and-ip-program-announces-first-round-of-grant-awardees-.html Thu, 29 Sep 2016 15:44:58 +0530 The Pfizer IIT-Delhi Innovation and IP Program', an incubation accelerator initiative co-created by Pfizer and the Foundation for Innovation and Technology Transfer (FITT) at the Indian Institute of Technology, Delhi (IIT-Delhi), has announced the first round of grant awardees. The projects selected under this platform aim to address India's enormous need for healthcare innovations that are not only unique in tackling the current healthcare challenges but also cost effective, scalable and easy to deploy. The innovators/start-ups will develop prototypes, which when scaled up, aims to improve the quality of lives of millions of people across the country. Through these innovations, the start-ups would focus on providing solutions to air pollution, stroke-led disability and infectious diseases. The innovations are: I. Healthcare Innovation from Idea to IP (Resident Incubation Program)a) Early stage diagnosis & antibiotic susceptibility test of typhoid in 7 hours by Saurabh Singhb) Wearable nasal air purification device with minimal air flow resistance by Debayan Saha II. Healthcare Innovation only at IP stagec) Bioactive nanofiber for bone regeneration by Dr. Shilpa Dev, Virtisbiolabsd) Multiboard- an upper extremity workstation for rural India by Dr. Harpreet Sachdeva, AIIMSe) Green manufacturing of pharmaceutical intermediates using novel enzyme by Dr. Raj Kumar, Cellzyme Biotech Resident incubation awardee Debayan Saha says, "We believe our solution is a breakthrough that is both current and forward-looking, aimed at serving large populations in the long run and will equip India to reduce burden of diseases that impede its economic development. We think discovering cures are significant scientific achievements for public health, however it is even more effective to prevent disease in the first place. It is important for innovations like ours to be encouraged and rewarded. The Pfizer IIT Delhi Innovation and IP program has really pushed us into a promising environment that aims to provide healthcare solutions to millions in the country." Eager to address a major health challenge in India, Saurabh Singh, Co-founder of Valetude Primus Healthcare Pvt Ltd. and the second innovator to receive the Pfizer IIT Delhi grant says, "Bacterial infections continue to be a major cause of deaths globally, particularly in resource-poor settings. In the absence of rapid and affordable diagnostic solutions, patients are mostly administered a broad spectrum of antibiotics leading to antibiotic resistance and poor recovery. At present, typhoid diagnosis takes up to three days, but our portable and cost-effective innovation will help expedite diagnosis to seven hours and ensure treatment." "We are excited to announce and give the first set of grants to the selected innovators under our flagship project - Pfizer IIT Delhi Innovation and IP Program," said S. Sridhar, Executive Director, Pfizer India, "With the winners of our program identified, the stage is set for advancements in healthcare that are born and brought up in India for the benefit of our people. Given this promising start, we want to maintain the momentum and work closely with FITT at IIT Delhi to help the innovators integrate and thrive in this new era of entrepreneurship and innovation in India. In doing so, this program falls right into the basket of the Government's Start Up India Stand up India campaign that creates a vibrant innovation ecosystem in the country and enhances the creation of intellectual property." "Looking at the phenomenal response from the industry, we cannot wait to get started with the next phase of the Program. We look forward to more and more innovators seeking inspiration reach out to us" Sridhar added. Pfizer is set to launch the second phase of the Program in October 2016, wherein another set of healthcare innovations with be identified for resident incubation and IP support.   Dr. Anil Wali, Managing Director, Foundation of Innovation and Technology Transfer, IIT Delhi said, "We were greatly encouraged by the diversity of applications received for the Pfizer IIT Delhi Innovation and IP Program from across the country. Over the years we have noticed an upward trend in technology-based healthcare innovations that range from - health apps, to wearables that prevent illness, to intelligent diagnostics that predict or diagnose a disease. The five selected projects are great examples of indigenous healthcare innovations and demonstrate tremendous potential. Their teams are outstanding with the right caliber to understand the on-ground health challenges in India and have used their understanding to focus on solving very specific problems." During the Program, the two shortlisted innovators seeking comprehensive support to translate their healthcare ideas into patents, will be provided two years of residential incubation at IIT Delhi, capital boost of up to Rs. 50 lacs for each innovator, high-profile mentoring support from IIT Delhi's faculty, access to infrastructure and prototyping laboratories, IP search and filing services, guidance from Pfizer's global experts, and access to venture capitalists and other industry linkages. The three selected innovators under the IP filing support who already have a ready proof of concept and are seeking to obtain a patent, will be provided with access to IP attorneys and services and cover the patent fee under the Program, upto 3 lacs each.   ]]> https://biospectrumindia.com/news/97/8574/perkinelmer-announces-new-organizational-structure-.html https://biospectrumindia.com/news/97/8574/perkinelmer-announces-new-organizational-structure-.html Wed, 28 Sep 2016 11:59:49 +0530 PerkinElmer, Inc. has announced organizational changes effective October 3, 2016 to better position PerkinElmer to grow in attractive end markets and expand share with the Company's core product offerings through an improved customer focus, more value-add collaboration and breakthrough innovations. PerkinElmer's Diagnostics business, focused on reproductive health, emerging market diagnostic solutions and applied genomics, will become a standalone business segment to better meet the needs of clinically-oriented customers in regulated markets. Prahlad Singh, who has been named Senior Vice President and President, Diagnostics effective October 3, 2016, will lead this business. PerkinElmer's Environmental Health and Life Science Solutions businesses will combine to form Discovery & Analytical Solutions. This combination will advance PerkinElmer's success in serving and innovating for its applications-oriented customers in the food, environmental, industrial, and life sciences markets. Jim Corbett has been named Executive Vice President and President, Discovery & Analytical Solutions effective October 3, 2016. "We are excited about taking the next step in our strategic evolution to drive increasing profitable growth and advance our mission of innovating for a healthier world," said Robert Friel, chairman and chief executive officer of PerkinElmer. "These organizational changes will accelerate our application and technology development efforts for the benefit of PerkinElmer's customers as we expand our capabilities to provide more integrated solutions that address critical needs around the globe."   ]]> https://biospectrumindia.com/news/97/8575/mapmygenome-selected-as-a-2016-red-herring-top-100-asia-winner.html https://biospectrumindia.com/news/97/8575/mapmygenome-selected-as-a-2016-red-herring-top-100-asia-winner.html Tue, 27 Sep 2016 16:27:38 +0530 Mapmygenome India has been named in the Red Herring Top 100 Asia award winners. This list is in recognition of the leading private companies from the region, celebrating these startups' innovations and technologies across their respective industries. "In 2016, selecting the top achievers was difficult as always," said Alex Vieux, publisher and CEO of Red Herring. "The variety, depth, disruption and traction we saw from the early stage companies to those with significant scale made 2016 a great vintage to judge. The Asia winners are representative of the amazing ecosystem that never ceases to astound, with new and experienced entrepreneurs continuing to push the barriers of innovation. As one of the winners, Mapmygenome should be proud of its accomplishment." Anu Acharya, CEO of Mapmygenome said, "Red Herring Top 100 Asia is a unique platform aspired by all startups. For Mapmygenome, it is time to celebrate this milestone and to focus on further innovation and excellence." Red Herring's editorial staff evaluated companies on both quantitative and qualitative criteria, such as financial performance, technological innovation and intellectual property, DNA of the founders, business model, customer footprint, and market penetration. This assessment of potential is complemented by a review of the track record and standing of startups relative to their sector peers, allowing Red Herring to see past the "buzz" and make the list a valuable instrument of discovery and advocacy for the most promising new business models in Asia.   ]]> https://biospectrumindia.com/news/97/8572/parexel-to-buy-execupharm.html https://biospectrumindia.com/news/97/8572/parexel-to-buy-execupharm.html Tue, 27 Sep 2016 11:47:20 +0530 PAREXEL International Corporation announced that the Company has entered into a definitive agreement to acquire ExecuPharm, Inc. ("ExecuPharm"), a leading, global functional service provider (FSP) serving the biopharmaceutical industry. The acquisition is expected to close in the next three weeks. Terms of the transaction were not disclosed. Established in 1995, ExecuPharm provides clients with qualified professionals across functional areas, such as clinical monitoring or study management, along with associated operational activities including onboarding, training, line management, performance management and policy administration. The company is headquartered in King of Prussia, PA, and it works with many of the top 20 and mid-sized and small biopharmaceutical companies. ExecuPharm's strong client relationships have led to 85 percent growth in the company in the past three years. "Functional services represent an established and growing model within the biopharmaceutical industry. Clients are increasingly using a combination of programmatic and functional outsourcing models," said Josef von Rickenbach, Chairman and CEO, PAREXEL. "With ExecuPharm, PAREXEL will expand and strengthen our existing functional services offering and capabilities to meet the growing market demand while allowing our clients to fulfill all of their clinical development outsourcing needs through a single company." Functional service providers offer biopharmaceutical clients stand-alone outsourced services, such as clinical monitoring, data management, biostatistics, site monitoring, study management, medical writing, pharmacovigilance and other related functions. Customers may outsource functions tactically, on a particular trial, or strategically to constitute or supplement an entire department. "We are excited to become a part of PAREXEL and offer our clients an expanded global presence, increased therapeutic expertise, broad product development knowledge, and high quality service. By providing clients the ability to outsource only certain functions, we provide clients flexibility in their drug development programs," added Maria Larson, Founder and Chief Executive Officer, ExecuPharm.   ]]> https://biospectrumindia.com/news/97/8571/medtronics-stealthstation-cranial-software-receives-fda-clearance-.html https://biospectrumindia.com/news/97/8571/medtronics-stealthstation-cranial-software-receives-fda-clearance-.html Tue, 27 Sep 2016 11:08:09 +0530 Medtronic plc announced that the U.S. Food and Drug Administration (FDA) clearance of StealthStation Cranial Software as an aid for deep brain stimulation (DBS) lead placement. The software is fully integrated with Medtronic's latest O-arm Imaging System, providing clinicians with a complete procedural solution for the planning and placement of DBS leads. The announcement was made at the Congress of Neurological Surgeons (CNS) in San Diego. With Medtronic's DBS Therapy, a small, pacemaker-like device called a neurostimulator is implanted under the skin of the chest and sends electronic signals to an area in the brain that controls movement. Thin wires - called leads - are implanted in the brain and are connected to the neurostimulator by an extension to enable the signals to reach the source of symptoms. The new StealthStation application, which integrates pre-operative planning, intraoperative imaging and technologies to help guide surgeons during cranial procedures, is designed to improve procedural workflow and allow for DBS lead placement with a high level of accuracy. "The new StealthStation software works seamlessly with O-arm to give me a single solution for pre-operative planning and real-time 3D imaging of the brain in the OR, and that streamlines my workflow for DBS lead placement," said Dr. Jonathan Carlson, MD, PhD, a neurosurgeon at Providence Spokane Neuroscience Institute in Spokane, Wash. "Now I have the essential information I need in one place, giving me - and my patients - even more confidence in the procedure." In the past 25 years, the StealthStation system has been used in more than 2.25 million procedures. The O-arm system has been used to help more than 200,000 patients over the past decade. Medtronic DBS neurostimulators have been implanted in over 140,000 patients around the world. Medtronic's full-body MR Conditional Activa® DBS neurostimulators help to reduce some of the movement symptoms of certain neurological disorders including Parkinson's disease and essential tremor. "We alleviate pain, restore health and extend life by providing informed and integrated neurosurgical procedures to our customers and their patients," said Scott Hutton, vice president and general manager of the Neurosurgery business in Medtronic's Restorative Therapies Group. "And as we transform the way the world treats patients with neurologic disorders, we'll utilize the breadth of our broad Brain Therapies portfolio in new and different ways to bring fully-integrated solutions like this to our customers."   ]]> https://biospectrumindia.com/news/97/8570/ge-healthcare-starts-bengaluru-accelerator-for-startups.html https://biospectrumindia.com/news/97/8570/ge-healthcare-starts-bengaluru-accelerator-for-startups.html Tue, 27 Sep 2016 11:07:31 +0530 5.8 billion. That's the number of people who need access to good quality healthcare. Partnering with Unitus Fund, Acumen, Aavishkar-Intellecap Group, and Villgro, GE Healthcare has started healthtech-focused startup accelerator five.eight. It is the first healthcare accelerator by the $18 billion GE Healthcare division. The programme will focus on startups post Series A funding. The team is looking to fund up to $5 million per startup from GE Healthcare, for the accelerator programme. "The idea of playing with the words five.eight is to focus on the world population that does not get access to quality healthcare and treatment procedures," says Terri Bresenham, President and CEO, GE Healthcare's Sustainable Healthcare Solutions. The portfolio companies of the impact funds - Aavishkar-Intellecap Group, Villgro, Unitus Seed Fund, and Acumen - will be among the initial applicants of the five.eight programme. Tricog, a Bengaluru-based healthtech startup that focuses on improving the heart attack survival rate is the first startup to be a part of the programme.John Flannery, President and CEO, GE Healthcare says, "We are looking at companies that have a proven model and market strategy. Being in India, we will have a partial focus towards Indian startups even if it is a global accelerator."   The team added that these startups will gain access to clinical mentors from GE Healthcare as well as to funding and strategic partnerships. They added that the assessment of the applications will be on the basis of market assessment of needs and the ability of the solution to meet the need. Terri added that while GE Healthcare has a strong focus on devices, the startups need not necessarily be restricted to them. She adds:If you look at Tricog, it has a mix of different solutions it provides. The idea is to find startups that are unique, different, and have a keen understanding of the problems that need to be solved; hence, the focus on commercially viable solutions. We believe that the solutions provided by these startups can change and impact lives across the globe.' GE Healthcare says they are very bullish of the five.eight accelerator. The team claims that it is a first step they are taking to explore the booming startup and healthcare market in India. On acquisitions, John added that they aren't looking at acquiring companies but are more strongly focused on strategic partnerships. "With our expertise and the innovations that the startups bring, we believe that global healthcare can see a complete evolution," says John.   ]]> https://biospectrumindia.com/news/97/8566/technology-graces-healthcare-at-1st-medical-electronics-innovation-summit.html https://biospectrumindia.com/news/97/8566/technology-graces-healthcare-at-1st-medical-electronics-innovation-summit.html Mon, 26 Sep 2016 13:00:00 +0530 The Ministry of Electronics and Information Technology launched the first edition of the Medical Electronics Innovation Summit 2016 at IIT Powai in Mumbai. The Summit was inaugurated by Ravi Shankar Prasad, Minister of Electronics and Information Technology, P. P. Chaudhary, Minister of State, Ministry of Electronics and Information Technology along with Sri Kamineni Srinivas, Minister for Health, Andhra Pradesh. "According to an estimate, the demand for medical electronics devices was around USD 1 Bn in 2012 and is expected to reach USD 6.5 Bn by 2020. Our global share is only 2% and in the coming years, there will be greater demand for medical electronics in the country in coming years", said Ravi Shankar Prasad. The key highlight of the Summit was signing of an MOU Signing between SAMEER (Society for Applied, Electronics Engineering & Research) and the Government of Andhra Pradesh, on conducting joint and comprehensive assessment of health technologies as identified starting with Dual Energy Linear Accelerator for cancer care development. With India's medical electronics market growing to $11.7 billion by 2017, the Summit witnessed a panel discussion on the scope of Foreign Direct Investment (FDI) in the healthcare sector, especially with opening up of 100% FDI for manufacturing of Medical devices in India last year. "Government provides medical electronics devices the same financial incentives for medical electronics devices which it provides for development of IT and telecom equipment. As a result, incentives like Modified SIPS, Electronic Manufacturing Clusters, EDF are available for the units investing in medical electronics devices", said Union Minister Prasad.   The integrated healthcare model is an initiative by the Government of India to bring together all the aspects of the healthcare sector to improve the methodology of the system. Top professors, researchers and experts from various key institute and colleagues spoke about the process innovation in healthcare services developing a sustainable model for accessible and affordable service through innovation. The day ended with power topic on Capacity Building and Infrastructure Management for technology driven medical electronics in India. "A major step taken by our Government was to allow 100% FDI through automatic route for manufacture of medical devices as early as January 2015. As a result of the incentives being offered by Government, several domestic and multinational companies have started their manufacturing activities in the country. These include GE, Philips, Wipro GE, Trivitron among others. We have received 7 proposals involving Rs 754 cr under MSIPS for medical electronics. However, when compared this investment with overall investment attracted under electronics manufacturing in other sectors like mobile manufacturing, LED, consumer electronics etc, this sector require more efforts", said Ravi Shankar Prasad . MeitY, SAMEER and CDAC have also taken steps which will stimulate innovation in this sector. CDAC Trivandrum had developed a programmable digital hearing aid which could be offered at nearly one-tenth of market price (USD 100 as against USD 1000 in market) in 2012. Similarly, SAMEER Mumbai had developed a Linear Accelerator for radiation treatment of cancer patients. A Microwave Disinfectant has also been developed by SAMEER Mumabi. "Medical electronics industry is undergoing transformation with the advent of Internet of Things. Wearables are emerging one of the fastest growing medical device segment. To support this effort, MeitY has, along with Nasscom, set up a Centre of Excellence at Bengaluru to provide an ecosystem of support for start-ups. One of the biggest concerns in medical electronics industry is the threat of cyber security. This area has been attracting the attention of global industry and turned out to be an opportunity for start-ups", said Union Minister. The Conference also presented 5 start-up companies from the healthcare sector pitching in their idea for it's Start Up Pitch Deck to a 3-member jury panel which comprising of Aditya Nataraja, Manager, IIT Patna Incubation Center, Prof. Milind Atre, SINE, IIT Bombay and Neel Bhatia, Director - Innovation and IP Ecosystem Development, Intel Technology India. ]]> https://biospectrumindia.com/news/97/8559/syngene-buys-strands-systems-biology-and-pharma-services-.html https://biospectrumindia.com/news/97/8559/syngene-buys-strands-systems-biology-and-pharma-services-.html Fri, 23 Sep 2016 11:24:00 +0530 Syngene International  has announced that they have completed a deal through which Syngene has purchased assets of Strand Life Sciences related to systems biology, Heptox and pharma bioinformatics services. This includes target dossier business and rights to NGS data analytics and Sarchitect platforms, supported by a strong scientific team. Financial details of the deal were not disclosed. Commenting on this development, Jonathan Hunt, Chief Executive Officer, Syngene International said, "Given the vast volumes of genetic material sequence data that is being generated globally, there is an increasing focus on biological information management and data analytics in drug discovery and development. Syngene is constantly looking for new opportunities to expand its service offerings and plans to expand into areas such as NGS, translational R&D, predictive toxicology and pre-emptive target validation services, all of which require strong bioinformatics capabilities. We believe Strand's bioinformatics platforms not only complement our existing integrated service platforms but will also meet our customers growing needs for bioinformatics and data analytic support." Chairman and Managing Director of Strand Life Sciences, Dr. Vijay Chandru, added "Strand is glad that the deal with Syngene gives it access to technologies from Strand to form part of its integrated discovery service offerings. This transaction is alsoPutting Science to Work key step for Strand to focus its energies on personalized medicine through clinical applications of all its genomics technologies." This deal gives Syngene access to Strand's patented Virtual Liver model and the NGS analytics platform. The Virtual Liver model is able to predict the toxic effect of different drugs or chemicals on the liver (both rat and human) using information from laboratory-based experiments prior to actual testing on live animals or humans. Strand NGS is an integrated platform that provides analysis, management and visualization tools for next-generation sequencing data.   ]]> https://biospectrumindia.com/news/97/8562/agilent-technologies-launches-new-panel-for-fast-fish-testing-on-dako-omnis-in-lung-cancer.html https://biospectrumindia.com/news/97/8562/agilent-technologies-launches-new-panel-for-fast-fish-testing-on-dako-omnis-in-lung-cancer.html Fri, 23 Sep 2016 10:03:01 +0530 Agilent Technologies announced the EU launch of a new CE-IVD labeled IQFISH lung cancer panel for automated analysis on Dako Omnis. The new panel enables routine pathology laboratories to easily integrate fast, high-quality FISH into their IHC workflow. This allows labs to simultaneously stain IHC and FISH slides and enable multiple FISH slides to be processed in just four hours, a process that often takes two days or more with traditional FISH. The new panel, comprising of ALK, ROS1, RET and MET IQFISH probes, was designed using the groundbreaking, oligonucleotide-based SureFISH technology utilizing formamide-free IQFISH fast hybridization buffer. Also read: Australia changes drug approval norms to speed up approval process "We are excited about the upcoming probe launches for Dako Omnis," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "Agilent is committed to improving the speed and accuracy of patient-sample processing and the quality of test performance. We know that these factors greatly affect treatment decisions and patient outcome." The lung cancer panel is the second IQFISH launch for Dako Omnis following its introduction of HER2 IQFISH pharmDx in 2015. ]]> https://biospectrumindia.com/news/97/8554/thermo-fisher-launches-new-automated-sample-purification-system.html https://biospectrumindia.com/news/97/8554/thermo-fisher-launches-new-automated-sample-purification-system.html Wed, 21 Sep 2016 11:14:37 +0530 The Thermo Scientific KingFisher Presto sample purification system will debut at MipTec 2016, the International Life Science Exhibition, within booth C40 in Basel, Switzerland. The Thermo Scientific KingFisher Presto system is designed to be part of an automated workflow using a liquid handler with a gripper or robot arm to purify samples with volumes from 50µL to 5mL. The instrument's small footprint allows for easy connection to several liquid handling instruments in either a side-by-side or on-deck configuration, allowing flexible selection of platform and use for a wide variety of applications. Stackable, polypropylene KingFisher plates and tip combs are designed to be placed by a robotic arm and suitable for many biological applications, including projects that require a sterile environment. "Built for high-throughput, highly automated labs requiring a robust, easy to use solution, the KingFisher Presto system provides reliable purification of DNA, RNA and proteins," said Ray Mercier, vice president and general manager of liquid handling consumables at Thermo Fisher Scientific. "An extension of trusted KingFisher technology, the system uses magnetic particle technology to integrate seamlessly into a variety of workflows, which greatly reduces hands-on time - saving lab resources and money." The KingFisher Presto automated sample purification system allows users to choose between 24- and 96- head magnets, depending on the volume and throughput requirements.Thermo Scientific BindIT software accompanies the KingFisher Presto system for protocol development, allowing users to create and modify their protocols and import Invitrogen and Applied Biosystems nucleic acid and protein purification kits.   ]]> https://biospectrumindia.com/news/97/8552/practo-hosts-loop-in-new-delhi.html https://biospectrumindia.com/news/97/8552/practo-hosts-loop-in-new-delhi.html Tue, 20 Sep 2016 11:17:39 +0530 Practo, a leading healthcare platform hosted India's largest annual conglomeration of thought leaders in healthcare, Loop to get valuable insights on 'Advancing Healthcare through Technology'. Technology is yet to be leveraged by the healthcare sector to unleash its full potential to work towards a healthier world. Issues such as healthcare infrastructure, high disease burden, affordability and lack of awareness still plague the nation and technology can play a crucial role in effectively solving these issues. Loop was an effort towards facilitating conversations among visionary healthcare professionals, CXO's, doctors and tech entrepreneurs. Some of the key discussions at Loop revolved around 'creating a successful tele-health network', 'bridging the gap between payers and providers', medical regulations to name a few. "I am really pleased to bring Loop to New Delhi, it's amazing to see how healthcare providers across the nation are embracing technology and together we are unfolding a new chapter in healthcare by addressing some of the most crucial issues that we face today. I believe that Practo in collaboration with other healthcare stakeholders including hospitals, pharma and insurance will be able to solve the healthcare problem and give patients a chance to a healthier and longer life."- Shashank ND, Founder & CEO, Practo.   ]]> https://biospectrumindia.com/news/97/8517/philips-healthcare-introduces-dream-series-products.html https://biospectrumindia.com/news/97/8517/philips-healthcare-introduces-dream-series-products.html Thu, 15 Sep 2016 11:23:17 +0530 Philips India has recently introduced a range of Dream series products to improve care for obstructive sleep apnea (OSA) patients. The Dream Family offers innovative, comprehensive sleep therapy technology with sleek, patient-driven design, and personalized tools to keep patients engaged and using therapy. Designed to increase patient adoption, long term use and enhanced efficiencies that could attend to patient's needs, the Dream Family helps patients get the sleep they need. The Dream Family includes the Dream Station Auto CPAP device and DreamWear mask. Dream Station Auto CPAP: DreamStation positive airway pressure (PAP) sleep therapy devices are designed to be as comfortable and easy to experience as sleep is intended to be. Connecting patients and care teams, DreamStation devices empower users to embrace their care with confidence, and enable care teams to practice efficient and effective patient management. DreamStation offers exceptional comfort, intelligent monitoring, motivation and feedback, and seamless connectivity to the care team for proven clinical care and effortless patient management. The Respironics DreamStation Auto CPAP comes in two models with SD card and without SD Card. DreamWear: It is an under the nose nasal mask. DreamWear's unique design offers many of the benefits of nasal and pillows masks to allow patients to have the best of both mask types. Allowing more freedom of movement and more comfort than their prescribed mask, DreamWear patients feel like they are not wearing a mask at all. The top of head connection of the device allows patient the freedom to move. The Under the nose nasal cushion prevents red marks, discomfort or irritation in the nostrils or on the nose bridge. The cushion comes in four sizes Small, medium, large and medium wide. The Fit Pack includes all 4 cushion sizes (S, M, L, MW) and 1 medium sized frame. ]]> https://biospectrumindia.com/news/97/8509/agilent-technologies-lowers-the-cost-of-multi-element-analysis.html https://biospectrumindia.com/news/97/8509/agilent-technologies-lowers-the-cost-of-multi-element-analysis.html Wed, 14 Sep 2016 12:44:30 +0530 Agilent Technologies Inc. (NYSE: A) today introduced a new spectrometer that will enable laboratories to run more samples and generate more revenue. The new Agilent 4210 microwave plasma-atomic emission spectrometer runs on air rather than flammable gas – a feature unique to Agilent MP-AES systems – making it both safer and less expensive to operate. This is especially important to laboratories in the food, agriculture, petrochemical, environmental and mining industries. The 4210 features an advanced valve system, an inert torch, a humidifier, a temperature-controlled spray chamber, a multimode sample-introduction system, and enhanced diagnostics software – all of which extend the instrument's analytical performance, sample throughput and ease of use. IIn addition, new automation software enables remote elemental analysis. This flexibility opens up new possibilities for applications such as on-site process stream monitoring and environmental monitoring. "We used the MP-AES to integrate into our automated river water monitoring technology, which formerly used colorimetric and electrochemistry analyzers,â€? said Michael Wang, general manager of Etran Technologies. “With the MP-AES system integrated into our technology, we can quickly analyze all the elements we want with excellent repeatability, accuracy and detection limits. The low cost of operation and inherent safety of the MP-AES also makes it ideally suited to this remote river water application.â€? “Laboratories that have the new 4210 MP-AES will have access to the lowest cost elemental analysis possible, giving them a competitive advantage over labs that don't have it,â€? said Philip Binns, Agilent vice president of spectroscopy products. ]]> https://biospectrumindia.com/news/97/8512/aimed-welcomes-govts-move-to-introduce-ethical-marketing-code-.html https://biospectrumindia.com/news/97/8512/aimed-welcomes-govts-move-to-introduce-ethical-marketing-code-.html Mon, 12 Sep 2016 12:20:51 +0530 The Government's move to put in place a separate, strict and mandatory 'Ethical Marketing Code' for medical device companies has been welcomed by the Association of Indian Medical Device Manufacturers (AiMeD). AiMed has stated that the proposed 'Code' will help curb many unethical practices currently being practiced by deep pocketed players to the detriment of Indian patients and Indian medical device manufacturers. The proposed code, at the discussion stage currently, seeks to put a total curb on many malpractices/ inducements such as foreign trips in garb of sponsoring for purportedly attending conferences for enhanced Training or expensive gifts being offered by some medical device companies to medical practitioners, their families and hospitals to influence prescriptions and orders in their favour. The pay-off in lieu of 'orders' not only distorts the market by vitiating fair competition but also hikes up the price of devices, ultimately to be paid by patients, common Indian citizens. Also read: Sun Pharma inks distribution pact with Japanese firm Mitsubishi pharma "We whole-heartedly advocate and support a strict and distinct 'Ethical Marketing Code' with penal provisions for medical device industry as it will help curb many unethical marketing practices being indulged in by powerful deep-pocketed players at the detriment of common Indian citizens and Indian medical device manufacturers," said Mr Rajiv Nath, Forum Coordinator, AiMeD.   The Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers, Govt of India - the nodal department for pharma and medical device industry - already has a 'Voluntary Code' for the Pharma Sector which is now being upgraded to 'Mandatory Code' or 'Strict Compliance Code' with punitive provisions. Till date this code was also applicable to medical device sector but like pharma sector, it also had little deterrence as it was a code without teeth. The Department is contemplating similar strict Code for medical device industry too. Currently, the Department is in the process of soliciting views of various stakeholders to draw a separate and exclusive code for medical device sector. Under the proposed code, no freebies, no extravagant hospitality, no pecuniary benefits under garb of Training etc. are to be offered to hospitals or healthcare professionals. Additionally to plug the legal loophole to protect consumers its prescribed every medical device's unit pack of sale to carry the MRP so that there are no excuses that the device is not an OTC (Over the Counter) product and hospital supply and hence not a consumer product .A media report about violations of the proposed code will be treated suo moto as a complaint against violator.   ]]> https://biospectrumindia.com/news/97/8505/aimed-proposes-complete-ban-on-import-of-pre-owned-and-refurbished-medical-equipments-.html https://biospectrumindia.com/news/97/8505/aimed-proposes-complete-ban-on-import-of-pre-owned-and-refurbished-medical-equipments-.html Thu, 08 Sep 2016 11:40:43 +0530 The Association of Indian Medical Device Manufacturers (AiMeD) has strongly opposed the idea of permitting the import of any kind of pre-owned and refurbished medical equipment on the grounds of serious health safety issue for Indian people as is being lobbied by a segment of importers from the platform of CII. In addition, it has cited disruptive and adverse impact on domestic manufacturing of medical devices which only now has beginning to gain pace. An 'Inter-Ministerial Committee of Government of India for Restricting Import of Refurbished Medical Equipment including Radiology Products & Flexible Medical Video Endoscopes' has recently solicited various stakeholders' view on the matter. Giving a detailed reasoning and analysis of ground realities, AiMeD has built a strong case against any leniency for permitting import of refurbished and pre-owned medical equipment. Also read: Allergan acquires gene therapy start-up   "We are for total ban on import of used, second-hand or re-furbished medical equipment as there are real and serious health issues for Indian patients. In addition, any leniency will have a serious setback for 'Make in India' program in medical device sector which is only beginning to pick-up," said Mr Rajiv Nath, Forum Coordinator, AiMeD. "Can we really leave our people at the mercy of sub-standard, obsolete and unreliable equipments which have been discarded in other countries? Are Indian lives so cheap? Why should we expose them to unsafe radiation? "Wondered Mr Nath. Detailing the health issues related to sub-standard and doubtful second hand medical equipment including radiology equipment and flexible medical video endoscopes, Mr Nath said that such equipments of doubtful efficacy and quality is leading to incomplete and wrong diagnosis, causing either inadequate or wrong treatment plus undesired medication whereby the deserving patient loose one last hope/chance for proper recovery owing to time constraints or even financial constraints and in some cases even get exposed to unsafe radiation . Imports of Products such as used Flexible Medical Video Endoscopy Systems along with Camera Imaging Systems affect Domestic Flexible Medical Video Endoscope Manufacturers and similarly the Radiology Equipment Manufacturers are equally distressed. "Import of second-hand and pre-owned equipments will seriously destabilize 'Make in India' program in high end medical equipment sector which is only now beginning to pick up," pointed out Dr Velu, Chairman of Trivitron . "We don't even allow import of pre owned cars so why allow import of pre owned medical equipment?"   ]]> https://biospectrumindia.com/news/97/8500/fortis-healthcare-and-wayforward-collaborate-on-emotional-wellness-programme.html https://biospectrumindia.com/news/97/8500/fortis-healthcare-and-wayforward-collaborate-on-emotional-wellness-programme.html Thu, 08 Sep 2016 10:00:43 +0530 Fortis Healthcare, India's leading Healthcare provider, and wayForward, a digital, mental and emotional health company based in USA, launched an app-based wellness programme in India. The programme uses techniques of Cognitive Behaviour Therapy (CBT) and Mindfulness to potentially help millions solve problems caused by stress, anxiety and other emotional or mental health issues in the comfort of their own homes, without the fear of stigma, through its unique "coach in your pocket" concept. The event was also marked by experts who spoke about stress and its impact on individuals and organizations in the present times. Dr. Samir Parikh, Director, Mental Health and Behavioural Science at Fortis Healthcare said, "Mental and emotional health issues are more common than we imagine and impact almost every family, placing a significant burden on individuals and society. Clinical experience and research data show that stress is ruining relationships and hurting our overall health and wellbeing. I believe this programme would make a positive impact on the wellbeing of individuals, hence benefitting organizations and societies at large." Launching the program, Mr Bhavdeep Singh, CEO, Fortis Healthcare said, "Many people today find themselves unable to manage daily stress in professional lives. They also find it hard to consult a mental health specialist as they feel embarrassed about it. Despite advancements on many fronts in India, there is a low level of awareness regarding stress and mental health. In such a scenario, this HR conclave by Fortis Healthcare and wayForward is a welcome initiative to bring various stakeholders together. This digital health programme is a very innovative and much-needed solution for our increasingly stressed society." Dr. Navya Singh, Founder, wayForward and researcher at Columbia University, New York explained, "Our mission is simple - to ensure that everyone has access to mental and emotional health support at all times. To accomplish this goal, we have created a solution based on scientifically proven techniques, which is available to users through their smartphones. Our research with users of the wayForward app in the US has shown that more than 80% cases showed improvement in just 3 weeks. The study also highlighted that problems, such as overeating, sleep disturbances and lifestyle diseases, can be consequences of mental and emotional health issues." The Asia-Pacific edition of Staying@work survey (2013-14) conducted by Towers Watson for Indian employees, revealed almost 1 in every 3 Indian employers had instituted stress or resilience management programmes in 2013 and an almost equal number planned to follow suit in 2014. With stress being ranked as #1 lifestyle risk factor in India, this number was expected to grow.   ]]> https://biospectrumindia.com/news/97/8501/cochlear-launches-first-off-the-ear-hearing-device-.html https://biospectrumindia.com/news/97/8501/cochlear-launches-first-off-the-ear-hearing-device-.html Wed, 07 Sep 2016 12:17:08 +0530 Cochlear Limited eleased its newest innovation - Kanso - a sound processor combining the most advanced sound processing technology with a discreet design. Ms Vandana Pisharody, Regional Director, South Asia at Cochlear welcomed the launch of Kanso explaining it is a remarkable step forward in offering solutions that address an important unmet need for customers living with hearing loss. "Our recipients are at the heart of everything we do and this innovation is in direct response to us listening to our customers. We identified the need in the market place for a solution that provides the advanced technology of a Cochlear sound processor combined with a discreet design. Kanso offers our customers all that and much more," explained Ms Pisharody. Also read: Global regenerative medicine market to grow by 13% Kanso is the smallest and lightest off-the-ear sound processor on the market providing the wearer with both discretion as well as enhanced comfort. The new technology is simple, discreet and smart as it has the ability to automatically adjust to different hearing environments providing a seamless experience from visiting a restaurant, to going to the movies. Kanso includes state-of-the-art Cochlear True Wireless technology, which helps people use the phone, hear over distance and in noisy situations. The True Wireless range of accessories allows the wearer to stream conversation, phone calls, music and television programs directly to their sound processor. "We are thrilled to be able to offer this new technology to the millions of people around the world living with disabling hearing loss," said Mr Jan Janssen, Senior Vice President of Design and Development, Cochlear. "Kanso features Cochlear's industry-leading technology, including dual microphones, SmartSound iQ with SCAN and True Wireless technology which all enable the wearer to hear better in difficult listening situations. Kanso provides wearers with best-in-class hearing performance in the real world." In Kanso clinical trials, 88% of people rated their overall hearing performance with Kanso to be the same or better than with their behind-the-ear sound processor.4 Most participants rated Kanso better than their own behind-the-ear sound processor on measures of comfort, look and feel and ease of use, with 93% of users rating listening to music with Kanso to be the same or better as with their behind-the-ear processor. Hearing loss is often not thought of as a debilitating health issue. However in adulthood it is associated with greater unemployment, increased risk of poor health, depression and increased risk of other conditions including dementia. Increasingly, evidence is showing cochlear implantation for adults as an effective intervention for a much wider group of candidates than had previously been thought.  The latest sound processor technology is called Kanso - a Japanese word for 'simplicity' - in recognition of the products sleek, discreet design that can be hidden under the wearers' hair. Kanso will be available in India from 01 September 2016. ]]> https://biospectrumindia.com/features/97/8499/hot-start-ups-pioneers-in-genome-editing.html https://biospectrumindia.com/features/97/8499/hot-start-ups-pioneers-in-genome-editing.html Tue, 06 Sep 2016 17:26:27 +0530 Genome editing encompasses an array of recently developed technologies with a wide application in the Life Sciences industry, and has the potential to be used as therapeutics in future. These techniques give researchers tools to precisely alter gene function to study their role, or alternatively create disease models for drug discovery and pharmacological studies. Dr Rohan Kamat (33) and Dr Srikanth Budnar (36) incorporated Bangalore-based Viravecs Labs in 2014 with the sole aim of being pioneers in genome editing in India. Dr Rohan and Dr Srikanth obtained their PhDs from ACTREC-TMC (The Advanced Centre for Treatment, Research and Education in Cancer - Tata Memorial Centre), the research arm of popularly known Tata Memorial Hospital in Mumbai. Post his PhD, Dr Rohan spent 3 years as a DST-Cognitive Science Initiative (CSI) post-doctoral research fellow at NCBS (National Centre for Biological Sciences) in Bangalore.   Being in Bangalore's biocluster, and exposed to all facets of the Biotech industry, the idea to start-off Viravecs Labs was seeded within the founders at Bangalore's C-CAMP (Centre for Cellular And Molecular Platforms), a centre for cutting-edge research and innovation in Life Sciences, where the start-up is currently being incubated. Dr Srikanth pursued a brief post-doctoral research at Mumbai's TIFR (Tata Institute of Fundamental Research) before joining the IMB (Institute of Molecular Bioscience) at the University of Queensland, Australia, for further research in molecular cell biology. During his research, Dr Srikanth harnessed the power of molecular tools, including viral vectors and Crispr-Cas9, to genetically alter various cell lines to study and understand gene functions. Dr Rohan adds that he and Dr Srikanth continually felt the importance of translational research. "Both of us share complete knowledge to develop transgenic mammalian model systems using various emerging technologies. During our PhD years, collaborations for these skills helped the participating groups, and the commercial value of the same was also obvious to us. The thought of using our knowledge and skills to make our independent careers pushed us to think of this entrepreneurial journey. The thought was further kindled by many factors including mentoring by the right people; being in close proximity to C-CAMP; the Biotechnology Industry Research Assistance Council's (BIRAC) Biotech Ignition Grant (BIG) scheme provided seed funding for novel, commercial ideas; and more so ever, the now-or never attitude," explains Dr Rohan. Plan of Action Once the founders set their eyes on their entrepreneurial journey, the plan of action was a little different for the duo. "We planned to go ahead only if we were awarded the grant under the BIG scheme. We were totally banking on the scheme for seed fund as we by ourselves were not in the capacity to start-off, especially Biotech being a highly capital-intensive industry. So we focused on writing for the grant and gave our best shot, and it worked! When we were awarded the grant, we went ahead and set-up our company on papers and presently we operate from C-CAMP," says Dr Srikanth. R&D takes a center stage at Viravecs, wherein platform technologies are developed to create clean model systems for Life Sciences research, with no off-target effects typically caused by collateral damage to genome while using the conventional methods. As an offset of these platform technologies, Viravecs also provide various genome-editing tools as per the needs of the clientele. "Highly customizable, low turnaround time, and low costs are some of the main features of the products and services offered by Viravecs," Dr Rohan comments. No Cakewalk Establishing a brand new lab was an experience of sorts, points Dr Rohan. "We came to our allotted bench space at C-CAMP with nothing in hand; and when we started we realized the challenge of taking care of numerous trivial and non-trivial things to have a fully functional lab. Also, this was the time when we had to be extremely judicious and efficient in using the funds at hand. "Every Rupee counts for a start-up lab like ours, unlike in well-established academic or industry lab, where revenue generation and expenditure is quite regularized. Each and every micro tips' cost was now visible. Stepping out of academic labs, where pretty much everything is taken for granted, all of that changed," he reveals. Although the founders were well aware of their product's market potential, convincing their clients was not easy "It is difficult to convince especially for a technology that is new, even for labs in the West; and when the technologies for these novel technologies come from a start-up, it is further challenging. However, we are hopeful about the Indian Life Sciences market, which we feel would give us good opportunities to prove our capabilities..." Dr Srikanth says. It also took a fair amount of time and effort for the founders to understand and execute the paperwork and administrative responsibilities. "Coming from a completely academic background, understanding the required legal procedures to start and sustain a commercial lab was also challenging," Dr Rohan recalls. Personal Savings Viravecs received tremendous help from C-CAMP; BIG partner Kalinga Institute of Industrial Technology - Technology Business Incubator (KIIT-TBI); and the start-up's fellow incubatees like Bugworks and Sea6 Energy. The seed funding for Viravecs Labs came from BIG scheme offered by BIRAC-Department of Biotechnology (DBT). In terms of investments, all the ancillary cost involved were spent by the founders from their personal savings. "Since we are at an early stage, the seed fund from BIRAC has been sufficient for running the research. As we progress through this year, we are hopeful to generate revenues through our technologies, and generate a decent turnover in the next 5 years to attract investments," Dr Rohan opines. Viravecs is currently working on 3 collaborations in the academics including InStem (Institute for Stem Cell Biology and Regenerative Medicine) and IISc (Indian Institute of Science) in Bangalore, and TIFR at Mumbai. It is also in talks with a major biotech company in Bangalore for 2 projects. It is also working with Aten Porus Lifesciences to develop novel processes and formulations to deliver genome editing tools in vivo. Its other collaboration is with Shilps Sciences in using micro fluidics platforms to enhance the robustness of genome editing tools. Exit Strategy According to the founder, the start-up's growth plans will completely depend on the funds it raises henceforth. Dr Rohan says, "We plan to generate ample revenues through our platform technologies. We are also in the process of writing for grants to develop versatile genome editing technologies for small animals. To achieve these targets we plan to expand our research team, and also have a team for marketing. It is too early to talk about our exit strategy, but we feel that we can share our technologies with bigger companies for better reach of our products and services." Viravecs aims to get in the market by mid-2017. "Alternatively, if we find a suitable partner to take our project to the market a little sooner, we will happy to be associated with them," Dr Srikanth expresses. Shorter Times The current schemes which fund start-ups, particularly the BIG Scheme from BIRAC, are providing amazing opportunities for researchers. However, these schemes provide funding for a shorter time of 18 months, which is good enough to test concepts and develop technologies. "But this time frame is too short to develop the technology into a commercial product and become self-sustainable," voices Dr Rohan. "The transition from early start-up to self-sustained company is difficult especially for Biotech ventures where it takes lot of time and revenues to make a successful product. The next level funding is quite difficult to obtain, and private funding is also fairly difficult at such early stages. It will be very helpful if the Government funding agencies come up with some competitive funding schemes for start-ups which have developed technologies that can mature into successful commercial products." Academia-Industry In the West, Academic-Industry partnerships are well defined and mature into fruitful collaborations. To help academic discoveries translate into commercial products, the Universities and Institutes have close tie-ups with industry, and numerous support systems are in place to achieve this without hurdles. "India has taken an interesting way to bridge the gap between discovery and translational science by setting up research incubators, especially for Biotech start-ups where the need for established infrastructure is immense," says Dr Srikanth. "The various funding agencies have come up with competitive seed funding for researchers with ideas and plans that has the potential to develop into a successful business. Though the process has started, sensitization of the academia is of utmost importance to translate any part of their research which has commercial potential. Vice versa, the companies can also have tie-ups with academia to develop reagents and technologies that can aid discoveries in sciences." Killers & Lessons According to Dr Rohan, the death of a start-up maybe and generally is a multi-factorial process. "The most important thing that can be a killer is the difference of opinion between the partners in the game. It is highly important to trust each other, define responsibilities, stick to them and ultimately deliver as a team. The moment the team starts becoming 'me versus them', the marriage called start-up begins to fail," he adds. "The second factor," Dr Srikanth comments, "that would kill a start-up is the lack of funding opportunities. As of now in India, there are very few schemes which patch up the gap between seed fund and series 'A' funding. The seed fund helps establish the set-up and get going with the PoC. Then there is a need to get the PoC to a sellable level for which funding is scant. A lot of start-ups fail at this level in spite of having potential to survive." Though it's the beginning of the journey for the founders, they have a lot to share about their entrepreneurial journey. "For one, we have learnt the most important thing in this journey is the network. We keep on exchanging notes with people of all sorts, from junior research fellows on the campus to the senior founders of established companies. There is always something to gain from everyone; and by default there is much to contribute as well. Networking helps connect two or more people whom we may know and are useful to each other; we may gain nothing from connecting them but we know some day they will help us too," Dr Rohan says. "Secondly," Dr Srikanth shares, "the entrepreneurial journey is a crash course in money and people management, particularly since we are never taught that in Science. Suddenly the cost of every unit of everything we use is visible and we start valuing it more. Optimum output from your colleagues is desired, all the while making sure that they are happy working with the start-up." A major advice that Dr Rohan offers to upcoming Life Sciences entrepreneurs is to have backup funds. "...With no backup funds, it is very difficult to do business development, and collaborations among others. As a start-up there is an intense need for entrepreneurs to invest capital for day-to-day functioning of the company. If backup funds are difficult, give the start-up idea a second thought!" Dr Rohan advices. Essential Qualities for Successful Entrepreneurship:  Collaboration Networking Open mindedness Patience ]]> https://biospectrumindia.com/features/97/8495/hot-start-ups-monitoring-the-critical-rhythm-.html https://biospectrumindia.com/features/97/8495/hot-start-ups-monitoring-the-critical-rhythm-.html Tue, 06 Sep 2016 13:21:22 +0530 India has 8 to 20 million heart rhythm disorder patients and about 50 million worldwide. Cardiac monitoring is widely used to identify heart diseases and in monitoring cardiac activity before and after surgery and other cardiac procedures. It is also used to assess the effects of therapeutic drugs on cardiac activity. Monitra's products detect heart rhythm disorders at real-time for pre-emptive treatments. Also read: Smart polymers market growth forecast at 19.98% CAGR to 2020 "We are developing wearable devices that make monitoring experience seamless, discreet and comfortable for patients that they can perform their regular daily activities while collecting rich clinical data for physicians. We are enabling our devices to connect over mobile networks to provide healthcare access at homes and also tackle last mile connectivity in rural areas," says Mr Ravi Bhogu, Founder, Monitra Healthcare. "India, unlike the West, is still largely an out-of-pocket driven market and hence making devices affordable is very important. We are toying with innovative product design and business models to make our devices cost-effective in India." Mr Ravi has lead R&D, marketing, sales and clinical support teams across India, the United States, China and Australia at Johnson & Johnson (J&J) and Global Cardiac Monitors prior to founding his venture.   He holds a Bachelor's degree in Electronics & Telecommunications Engineering from the University of Mumbai, an MS degree in Electrical Engineering from the University of Houston, USA, and an MBA degree from Johnson School, Cornell University, USA. Co-founder and wife of Mr Ravi, Ms Aparna Bhogu has expertise in distributed IT systems. She has a Master's in Information Systems Management from Carnegie Mellon University, USA. Mr Ravi's brother Mr Sashank Bhogu is another co-founder who has experience in database systems, user acceptance testing and software production environments. He has an Engineering degree in Information Technology from Mumbai University. "A fabulous team, good go-to-market plan and resources are most critical for a start-up. On the team front, I was lucky to find two critical product development resources within my family itself," he expresses happily. During his MBA at Cornell in 2008, Mr Ravi explored the idea of starting cardiac monitoring services in India. His research at that time told him that the market was not ready for quick adoption of such technologies because mobile networks, a key enabler, were not so strong in the Indian market. However, when his ninety-year-old grandfather suffered a cardiac event, it almost took days for doctors to confirm the episode. "This event was the tipping point, and I decided to take the plunge," Mr Ravi reveals. Finding the right team with composite skills is most important for a start-up. Monitra's software and database requirements were taken care by both the co-founders. "It took us some time to find a person with good embedded engineering skills and mixed signal experience. India has a shortage of skilled embedded engineers while the demand is fast rising with advent of Internet of Things (IOT)," Mr Ravi adds. It is important for entrepreneurs to get plugged into the entrepreneurial eco-system to gain access to right resources such as regulatory compliances, technology licensing and management, IP management, fund-raising and networking. "I would like to acknowledge the fantastic support lent by IKP Knowledge Park in Hyderabad during the early stages. They have built a fantastic eco-system for biotech entrepreneurs," Mr Ravi appreciates. The founder initially raised money from family and through his own savings to get the venture started. "My grandfather," he reveals, "was the first to put in the seed amount. Since then, we have been focusing on raising money through innovation grants in the biotech and healthcare sector to fund our R&D. We plan to raise equity rounds as we have the minimum viable product in place now." Monitra has a prescription-based business model. It has identified cardiac electro-physiologists, cardiologists and MD physicians as its primary target user segments. The start-up's goal now is to run pilots in smaller geographies, in a state or two to establish minimum viable business model that can be easily scaled in other parts of India. "Simultaneously, we will work on getting regulatory approvals like CE and then 510k. This will get us access to global markets," Mr Ravi says. "Our goals over the next two years will be industrial design, clinical validation and running pilots to test the product and our assumptions in commercial model." The company is exploring collaboration with DuPont for developing breathable materials for its devices in the Indian marketplace, and have jointly applied for United States India Science and Technology Endowment Fund. "On the commercial side," the founder says, "we are looking to establish partnerships with med-device and pharmaceutical companies who stand to benefit from early diagnosis of heart rhythm disorder ailments." Life Sciences and Healthcare start-ups involve long gestation cycles and good amount of investment upfront. Mr Ravi has a simple suggestion to the Government. "We request for exemption from income tax for start-ups in our industry for at least first ten years of operation so that profits can be plowed back into growing the business. The Government stands to benefit far more from successfully scaled start-ups in terms of taxes, employment and accessible medical care," he opines. The healthcare infrastructure in the urban towns are built mostly by the private sector while rural places are covered by public sector. There is significant demand for healthcare in rural India but there is a limited capacity of skilled healthcare professionals. "Technology and innovation can be huge enabler to solve this supply demand dichotomy and ensuring last mile reach," explains Mr Ravi. "However, public sector procurement mechanisms such as tenders, solely rely only on established companies with prior track record. This stands as a big deterrent for technology and innovation in the rural healthcare space. Government needs to not only establish mechanisms to quickly adopt good technologies but also encourage them for the benefit of rural India." In the Indian context, simple-to-use Point-of-Care diagnostic devices that use technology to assist screening communicable and as well as non-communicable diseases are seen as emerging. With the advent of smartphones and consumer exposure to excellent design in consumer electronics, patients are now expecting the same level of product design and ease-of-use in their medical devices. "Technology is enabling access to healthcare at home rather than having to go to a doctor's clinic," he comments. For the emerging entrepreneurs, Mr Ravi explains, "Visit start-up events and talk to as many entrepreneurs in your field to learn from their experiences. Find your own path. Most importantly, get your family behind your decision as they are the ones who will be your support system during your low moments, and a root during your triumphs. Healthcare industry is complex with big established players. The rate of disruption is not as fast as in the consumer industry. It is important to note that it is a regulated market and there are established norms to follow. It is important to know what can and cannot be disrupted. Quality is very important in this industry and should focus on it right from the beginning. It can result in significant delays and cost overruns." Mr Ravi recalls that his mother always wanted to start her own business. However, owing to responsibilities and taking care of her two kids, she couldn't pursue her dream. "I'm so glad that at least I have been able to fulfil her dream to a certain extent," Mr Ravi joyfully signs-off. Monitra's Milestones:  Received BIG from BIRAC in May 2015 Completion of functional prototype of Smart MCT with wires. This version will be able to acquire biopotential signals, digitize, filter unwanted signals, compress data and transmit over wireless networks to the respective web servers and database systems with report generation capability. The next prototype in progress is said to be without wires and closer to the actual product Two provisional patents filed Vendors for sourcing materials, industrial design, prototyping and manufacturing identified   ]]> https://biospectrumindia.com/interviews/97/8504/indias-diagnostics-queen.html https://biospectrumindia.com/interviews/97/8504/indias-diagnostics-queen.html Tue, 06 Sep 2016 13:20:00 +0530 Despite the hard struggles in a male-dominated society, women have fought bravely and stood their grounds against all odds. Ms Ameera Shah, the MD and promoter of Mumbai-based Metropolis Healthcare, isn't an exception either. Though she took over her father's business, the journey wasn't a cake walk. She was often mistaken for a secretary, and had to overcome gender discrimination and belittling from junior male colleagues. In her exclusive interview to BioSpectrum, she shares her insights on Indian diagnostics scene, the company's next market expansion plans, and ultimately her own entrepreneurial struggles and immeasurable efforts in building her own diagnostics kingdom. Excerpts:Q: What trends are shaping up the Indian diagnostics space? Ameera Shah: The most important trend today that we observe is the heightened awareness of the new age customer. They take their health in their own hands, take preventive measures and want to lead a healthy lifestyle. For today's customer, health is about wellness rather than the absence of illness which is an extremely wonderful trend.   On the technical side, there was a time when doctors from India sent blood samples abroad for hormone and thyroid testing. Scope of diagnosis was extremely limited in India. My father, Dr Sushil Shah, saw an opportunity and brought many new tests and technologies to India for the first time. Q: Tell us about your major growth drivers in India and other countries. AS: Cutting-edge technology, innovative work equipments, expansive logistics network and rigorous processes are the keys to Metropolis' growth in the country. These allow us to deliver precision and accuracy in every single test. Additionally, Metropolis has expanded into new service lines such as clinical trials, hospital lab management, home health services, preventive health check-ups, and corporate and wellness solutions. Q: What are the challenges in building a diagnostics business in India? AS: There are multiple challenges when you start expanding. In India, the dynamics of each city is different. What works in Surat may not work for Patna or Cochin. While entering each new market whether through a green field or an acquisition, it is important to study the market in depth and cut strategies accordingly. In India, each state and each city is penetrated like a new market. Some of the broad challenges in India can be summarized as lack of trained talent, cost of infrastructure, cost and volume dilemma and pricing challenge. Q: What factors do you consider while entering a new market? AS: Entering new markets, as it may seem, is not really easy. In case of a diagnostic business, we have to look after the following parameters including local competition, brand recognition and recall, economic markets, political and policy scenario, and legal jurisdictions. Q: Which markets would you be expanding to in the next couple of years? AS: We want to extensively expand in the North Indian region and Africa specifically. Moreover, we are delving deeper into the geographic regions in all countries where we are already present. We see potential in our growth in the African continent where we are gradually expanding since the last five years. Q: Which areas in diagnostics are still untapped or needs more attention? AS: While corporate players have ensured standardization of processes, it is important that government takes measures to bring in regulation to the diagnostic sector. A change in the regulatory scenario can transform the landscape of the industry. Accreditation need to be made mandatory so as to ensure labs maintain basic protocol. This will ensure more accurate reports, right diagnosis and disease management and in-turn better healthcare costs for the masses. Q: Any M&As on the cards? AS: Our current plans are to expand geographically within regions we are already present in. We will make any announcements for mergers or acquisitions whenever they are in the pipeline. Q: Are there any advantages in being a woman in this industry? AS: There are no advantages in this industry for women. From my personal experience, I would like to highlight that the diagnostic industry isn't the easiest to enter especially for a woman. There are a lot of preconceived notions attached to women. My first challenge was to change Metropolis from a sole proprietorship to a company. Being a woman entrepreneur, I had to face multiple instances of gender discrimination, which meant from being mistaken for a secretary to constantly being undermined by my junior male colleagues. This industry is dominated largely by men and for me to make a mark I have struggled my way through. Many may think it's a family business and would have been easy for me, which is definitely not the case. I have taken a lot of time and put in immeasurable effort to bring Metropolis to these heights. Q: Message to all the Indian women entrepreneurs? AS: In India, from the very beginning women are taught that their greatest asset is gold or jewelry. I strongly believe that for any woman, not just a woman entrepreneur, her greatest asset is her confidence - confidence to make her choices; be it personal or professional life. I will urge all women to embrace their right to confidence. While the society might take time to transform completely, women can start introducing gradual changes in their lives. This will lead up to the process of self discovery. The gender battles that women generally face in the workplace and the ones that a women entrepreneur will face are different. For a woman businessperson, because you are in charge of building the organization and the culture, the situation is unquestionably different. But for a woman entrepreneur, you have to go out and sell your story because you are building your own brand. Q: How do you manage work-life balance? AS: While it's not easy to take time out of the daily grind, I try to remove some time for myself every week. I regularly play tennis and work out at least thrice a week. I love the outdoors and so try to get in some sailing, camping and trekking whenever possible. Any down time I get is divided between activities that boost my physical and mental health, and spending with my loved one. Q: What next for Metropolis? AS: Metropolis is amongst the top 1 percent labs in the world in terms of quality and accuracy of reports. We want to gain more market share in North India and hence going more aggressive in the north. We have been in an expenditure phase for the past two to three years where we have been investing in our people, infrastructure, distribution, network and sales. Now I am hopeful about experiencing the results of the work we've been doing. Q: When do you think Metropolis will be ready for its IPO debut? AS: It might be ready in the long run, however, not right now.   ]]> https://biospectrumindia.com/features/97/8421/global-antibody-production-market-to-reach-13-28-bn-by-2021.html https://biospectrumindia.com/features/97/8421/global-antibody-production-market-to-reach-13-28-bn-by-2021.html Fri, 26 Aug 2016 17:58:25 +0530 The improved approval rate of therapeutic antibodies by regulatory authorities, patent expiry of blockbuster monoclonal antibodies, increasing adoption of targeted immunotherapy, and increased R&D expenditure of pharmaceutical and biotechnology companies are driving the overall antibody production market. The increasing prevalence of infectious diseases and rising demand for protein therapeutics are expected to provide growth opportunities for players operating in this market. Based on end users, the market is segmented into pharmaceutical and biotechnology companies, research institutes, and diagnostic laboratories. See Also: India's medical devices market will hit $17.6 bn by 2020 The pharmaceutical and biotechnology companies segment is expected account for the largest share of the antibody production market and is estimated to register the highest CAGR.   The large number of drug development procedures to meet the shortened industry timelines is driving significant investments by companies towards research and development activities; this is a key market driver for this end-user segment. The prominent players in the antibody production market include GE Healthcare (US), Thermo Fisher Scientific (US), Sartorius (Germany), Merck KGaA (Germany), Pall (US), Sigma-Aldrich (Germany), Eppendorf AG (Germany), Cellab (Germany), INTEGRA Biosciences (Switzerland), and FiberCell Systems (US).   ]]> https://biospectrumindia.com/features/97/7700/biosimulation-market-size-to-reach-3-77-bn-by-2024.html https://biospectrumindia.com/features/97/7700/biosimulation-market-size-to-reach-3-77-bn-by-2024.html Wed, 24 Aug 2016 15:00:24 +0530 The unprecedented global shift in the adoption of unhealthy lifestyles is resulting in the high prevalence of chronic diseases, such as cancer and diabetes, is expected to drive the biosimulation market during the forecast period. In addition, the rising geriatric population base highly susceptible to acquire the aforementioned chronic diseases result in enhanced demand for highly efficacious pharmacological drugs. This high requirement of efficacious drugs can be effectively met at a faster rate through the incorporation of the in silico approach, thus creating a high potential for biosimulation market growth opportunities in the future. Furthermore, increasing drug resistance, high drug failure rate, and availability of limited drugs to treat several diseases such as AIDS, pneumonia, tuberculosis, and others indicate the indisputable requirement for the incorporation of biosimulation in the drug discovery and development process. See Also: An exclusive look inside KIIT's hottest tech biz incubator   The widespread application of the in silico approach to developing efficacious drugs would generate drugs of greater potency in the market within a shorter span. The increasing demand can be attributed primarily to the significant cost reduction in the clinical trials and drug development & discovery process. This is due to the fact that the in silico software can predict adverse reactions, toxicity, and efficacy of the drugs in the early stages of the drug development, thereby reducing the probability of drug failure at the later stages and consequentially, control the overall expenditure. These above-mentioned factors serve as key reasons responsible for the heightened market demand. In 2015, North America dominated the overall biosimulation market at over 50%. The presence of regulatory authorities, consistently inclined towards ensuring patient safety, is a crucial factor presumed to be responsible for the dominant market share of this region. Moreover, the presence of highly skilled professionals also serves as a significant growth driver. The numerous collaborations amongst the leading players that are being undertaken to promote the incorporation of biosimulation systems are expected to be responsible for bolstering the growth in this region.   ]]> https://biospectrumindia.com/news/97/8215/fda-allows-marketing-of-first-of-kind-computerized-cognitive-tests-.html https://biospectrumindia.com/news/97/8215/fda-allows-marketing-of-first-of-kind-computerized-cognitive-tests-.html Tue, 23 Aug 2016 14:12:46 +0530 The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury. The device is manufactured by ImPACT Applications, located in Pittsburgh, Pennsylvania, USA. ImPACT and ImPACT Pediatric are not intended to diagnose concussions or determine appropriate treatments. Instead the devices are meant to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury.   The results are compared to an age-matched control database or to a patient's pre-injury baseline scores, if available. See Also: Sanofi receives FDA approval for Adlyxin "These devices provide a useful new tool to aid in the evaluation of patients experiencing possible signs of a concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game," said Dr Carlos Peña, director of the division of neurological and physical medicine devices at the FDA's Center for Devices and Radiological Health. ImPACT software runs on a desktop or laptop and is intended for those ages 12 to 59, while the ImPACT Pediatric runs on an iPad and is designed for children ages 5 to 11. Only licensed health care professionals should perform the test analysis and interpret the results. Traumatic brain injuries account for more than 2 million emergency room visits in the United States each year, according to the US Centers for Disease Control and Prevention, and contribute to the deaths of more than 50,000 Americans. A significant percentage of these injuries are considered to be mild. A concussion is considered to be a mild traumatic brain injury. The manufacturer submitted over 250 peer-reviewed articles, of which half were independently conducted clinical research studies. The research publications analyzed the scientific value of the ImPACT devices including the devices' validity, reliability and ability to detect evidence of cognitive dysfunction that might be associated with a concussive head injury. The FDA concluded that these studies provide valid scientific evidence to support the safety and effectiveness of the ImPACT and ImPACT Pediatric devices. The FDA reviewed the ImPACT device through its de novo classification process, a regulatory pathway for novel, low- to moderate-risk medical devices that are first-of-a-kind, for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices. ]]> https://biospectrumindia.com/news/97/8400/vyome-biosciences-closes-14-million-series-c-financing.html https://biospectrumindia.com/news/97/8400/vyome-biosciences-closes-14-million-series-c-financing.html Tue, 23 Aug 2016 13:12:10 +0530 Vyome Biosciences, a clinical-stage specialty biopharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes announced today that it has closed $14 million Series C financing round. This financing round was led by Perceptive Advisors, a leading New York-based life sciences fund and, Romulus Capital, a Boston-based venture capital firm, along with participation from existing investors including Kalaari Capital, Sabre Partners and Aarin Capital. "We are very excited to announce the closure of our Series C financing. The support from leading global and leading life investors and the continued support from our largest existing shareholders validates our Company's strategy, science and development programs. The Company will utilize these funds predominantly to advance the clinical development of its lead product, VB 1953 and will allow us to completion of important milestones of clinical results. In addition, the Company will continue to advance the development of other proprietary products pipeline in the preclinical stage", said Venkateswarlu Nelabhotla (N. Venkat), Co-Founder & CEO, Vyome Biosciences. "Vyome is well positioned as a clinical stage company with a rich pipeline to becoming a leader in antimicrobial resistance and treatment of skin infections with the new funding round. This influx of funding also validates our hypothesis that innovation-driven R&D can attract top global investors", remarked Dr. Shiladitya Sengupta, Co-Founder of Vyome and an assistant professor of medicine at Harvard Medical School. According to the American Academy of Dermatology, Acne represents the most common skin disease, affecting 85% of teenagers and affects 40-50 million people in the US. Approximately 40% of acne patients are suffering from antibiotic resistance. Physicians around the world have cited a large unmet need for new, improved topical therapy options, vis-à-vis the current available topical products. Vyome's VB 1953 targets this potential USD 2 Billion market of antibiotic resistant acne. VB 1953 had its IND (Investigational New Drug) application accepted by the US FDA recently, and the company will soon be initiating clinical studies in USA. Apart from lead program VB 1953, Vyome also has a deep pipeline of preclinical New Chemical Entities (NCEs), unique in their ability to resist the development of resistance based on its patented Dual Action Rational Therapeutics (DARTs) technology. In addition, Vyome has clinically proven antifungal products based on its breakthrough technology platform Molecular Replacement Therapy (MRT), for which Vyome is currently pursuing commercialization discussions globally. ]]> https://biospectrumindia.com/features/97/1074/global-bioinformatics-market-to-touch-30-87-bn-by-2020-.html https://biospectrumindia.com/features/97/1074/global-bioinformatics-market-to-touch-30-87-bn-by-2020-.html Fri, 19 Aug 2016 16:13:36 +0530 The global Bioinformatics market is expected to grow at a CAGR of 15.5% between 2014 and 2020. The market was worth $10.04 bn in 2013 and is projected to reach $30.87 bn by the end of 2020. The drug development segment is anticipated to lead all application segments. North America is expected to maintain its dominance in the global Bioinformatics market with a revenue worth $11,927.9 mn by 2020. Asia-Pacific is expected to witness the highest growth with a CAGR of 18.7% throughout the forecast period. See Also: Can predictive genomics take-off in India? The implementation of expansion strategies to enhance market share will increase the intensity of competitive rivalry on the global level for the existing market players, reports market research firm, Transparency Market Research (TMR) in a new study. To maintain their position in the global Bioinformatics market, the large number of market players operating in the global Bioinformatics market are investing in research and development projects. They are also looking forward towards technological advances for increasing application in biosciences and integrated information technology. The top three market players in the global Bioinformatics are Affymetrix, Accelrys, and CLC bio. They together comprise approximately 34.6% of the overall global Bioinformatics market in 2014. The prevalence of high entry barriers is estimated to increase the rivalry between the numerous existing companies in the global Bioinformatics market, making it highly fragmented. The existing companies are focusing on the implementation of acquisition strategies and collaborations in order to enhance their product portfolio and expand their market reach. The expansion of biotechnology applications in fields of forensic research and disease diagnosis is drawing the attention of various healthcare organizations and professionals. According to the TMR report, biotechnology with technological and process advancements tends to create high-wage job opportunities in developing and developed countries due to which governments are focusing on the growth of the biotechnology industry. For instance, The Biotechnology Industry Organization of the United States of America promotes collaborations between industry participants, academic organizations, and state governments of the country in order to develop bioscience groups. In this regard, the state governments are also increasing the implementation of strategies and programs to create job opportunities in the field of bioscience. Many companies have implemented reimbursement policies funded by the governments to train employees in order to fulfill the requirement of skilled employees working in the field of Bioinformatics services. Thus, the initiatives taken by governments to support research and development projects and creation of jobs in the biotechnology sector are anticipated to boost the global demand for Bioinformatics services. For better and accurate results, it is imperative that the Bioinformatics techniques are operated by skilled personnel. The need for heavy investment in installation and tools upgradation training tends to impede the growth of the industry. Due to this, there is a lack of skilled manpower in the Bioinformatics sector who can adapt to sophisticated and high-end biotechnology process and techniques. The scarcity of skilled workers is hindering the growth process of large clinical laboratories as they struggle to automate their processes. On the other hand, the small and medium laboratories have amplified their efforts to abridge and boost their operations with the available resources. Research and development activities also demand highly skilled personnel, but the lack of it is obstructing the growth process making it difficult for organizations and market players to benefit from their research investments. However, the expansion in web-based services for research and development is likely to cut down the cost of R&D processes. The web-based Bioinformatics segment is projected to witness substantial growth in the upcoming years in the global Bioinformatics market. ]]> https://biospectrumindia.com/news/97/8333/infosys-narayana-health-to-launch-robotic-surgery-institute-.html https://biospectrumindia.com/news/97/8333/infosys-narayana-health-to-launch-robotic-surgery-institute-.html Fri, 19 Aug 2016 11:10:05 +0530 Supported by Infosys Foundation, Narayana Health has launched an Institute of Robotic Surgery at its flagship unit at Narayana Health City, Bengaluru. The Foundation has donated the da Vinci Robotic Surgical System which will be used primarily for prostate, kidney, gynecological, colorectal and select head and neck cancer surgeries. Through this collaboration, the Foundation intends to encourage and enable rapid adoption of robotics in healthcare, and provide access to affordable, minimally invasive surgeries to a large number of people of the country. The creation of the Infosys Institute of Robotic Surgery is also aimed at training and providing research opportunities for use of robots in complex surgeries and to indigenize the production of such technology in India. Also read: Siemens, INSIGHTEC partner for Neuro technology Speaking on the importance of robotic surgery, Mrs. Sudha Murty, Chairperson - Infosys Foundation said, "The need to adopt and continually update treatment protocols that reduce errors is crucial for a country like India, which sees high patient volumes and a wide spectrum of complex diseases. Robotic surgery, with its high degree of precision and faster recovery time, has the potential to address this efficiently. Our partnership with Narayana Health, incontestably a pioneer in delivering world-class healthcare, is aimed at encouraging rapid adoption of robotics in healthcare in India. Through this endowment, we also intend to provide impetus for further research in this area, and enable the masses to reap the benefits of affordable and high-quality treatment."   ]]> https://biospectrumindia.com/features/97/8362/genotyping-market-projected-to-reach-37-1-bn-by-2024.html https://biospectrumindia.com/features/97/8362/genotyping-market-projected-to-reach-37-1-bn-by-2024.html Thu, 18 Aug 2016 17:46:39 +0530 The global genotyping market is expected to reach $ 37.1 billion by 2024 according to a new report by business consulting firm, Grand View Research. The increasing demand for genotyping tests to evaluate drug efficacy and safety is one of the major drivers for the genotyping market. Genotyping tests are widely used in selecting a highly responsive, patient population subset against a specific drug candidate before initiating clinical trials. The rising need for affordable genotyping services coupled with the high demand for personalized medicines is also expected to propel the market growth. Major pharmaceutical companies are collaborating with diagnostic manufacturers for the development of novel biomarker-based therapeutics. Also read: Venous Thromboembolism therapeutics market set to hit $3.7 bn by 2025   Significant opportunities for the growth of this market are anticipated due to the above-mentioned collaborative initiatives. The increasing awareness for prenatal genetic testing pertaining to early detection of chromosomal abnormalities in the high-risk population, the introduction of technological advancements, and the increasing R&D funding are the other factors accentuating the market growth over the forecast period. ]]> https://biospectrumindia.com/news/97/8348/siemens-insightec-partner-for-neuro-technology.html https://biospectrumindia.com/news/97/8348/siemens-insightec-partner-for-neuro-technology.html Thu, 18 Aug 2016 11:57:45 +0530 INSIGHTEC,has announces the signing of a strategic agreement with the global leader in Magnetic Resonance Imaging, Siemens Healthineers. The strategic collaboration will involve the development of compatibility between Exablate Neuro and Siemens leading 1.5T and 3T clinical MRI systems, MAGNETOM Aera and Skyra. With this agreement, Siemens Healthineers follows its strategy of broadening and complementing its diagnostic imaging portfolio with advanced therapy solutions. Both parties will work towards providing access to Exablate Neuro for installed base, as well as new product installation customers. Also read: How innovating emerging markets is set to disrupt the global surgical care industry? Exablate Neuro is the world's first and only CE and FDA-approved device for the non-invasive application of MR guided focused ultrasound to treat essential tremor and other conditions. Clinical research, development and regulatory approvals are ongoing for additional neurosurgical applications and markets. "Our agreement with Siemens Healthineers will allow us to significantly expand Exablate Neuro's market presence. Siemens has embraced our technology andtogether we will bring our therapy to significantly more patients and providers," said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.   "INSIGHTEC is committed to continue investing in research and development of MRgFUS technology. The strategic collaboration with Siemens Heathineers will allow more patients and researchers globally to benefit from the unique MRgFUS technology," he concluded. Dr Christoph Zindel, Senior Vice President and General Manager of SIEMENS Healthineers' Magnetic Resonance business further highlights the importance of the agreement: "This strategic partnership of two leading organizations is exciting and further underlines Siemens Healthineers' strategy of enabling better patient outcomes by broadening its diagnostic imaging portfolio into advanced therapies in the area of neurological and other disorders. Together with INSIGHTEC and its innovative technology, we will jointly drive healthcare further together with our strong research and clinical customer network worldwide." Exablate Neuro uses focused ultrasound waves to precisely target and accurately ablate tissue deep within the brain with no incisions, and while minimizing damage to adjacent healthy tissue. Siemens MR imaging plans to provide patient-specific treatment planning and continuous temperature monitoring for assessing treatment outcome in real-time during Exablate Neuro procedures.   ]]> https://biospectrumindia.com/news/97/8488/how-innovating-emerging-markets-is-set-to-disrupt-the-global-surgical-care-industry.html https://biospectrumindia.com/news/97/8488/how-innovating-emerging-markets-is-set-to-disrupt-the-global-surgical-care-industry.html Wed, 17 Aug 2016 11:53:00 +0530 The growth of emerging markets is poised to transform the delivery of surgical care around the world by 2030, according to a new report. The emphasis will be on affordable technology for early diagnosis; portable modular equipment for minimally invasive and robotic surgery; and smart systems incorporating low-cost sensors and mobile technology to track clinical outcomes and improve team-based surgery. The report summarises the findings of a workshop held in Boston earlier this year by product design and development firm Cambridge Consultants. It offers unique insight into the future of emerging markets surgical care - as seen through the eyes of industry leaders. And it looks at how these new approaches to healthcare will extend beyond emerging markets to disrupt and transform how affordable quality surgical care is delivered globally. Also Read: Kokilaben Dhirubhai Ambani Hospital announces series of major investments in comprehensive cancer treatment "More than 85% of the world's population lives in emerging markets, yet many of these people have no access to affordable quality healthcare, particularly complex treatment like surgery," said Rahul Sathe, head of surgical innovation for emerging markets at Cambridge Consultants. "Inadequate hospital infrastructure, a scarcity of qualified clinicians and fragmented healthcare ecosystems prevent successful surgical care. The surgical device industry has unprecedented growth opportunity to address the unmet needs of very large patient populations."   The report spells out the huge opportunities for technology disruption in emerging markets. Infrastructure and regulations are still being formed, and industry legacy is not particularly strong - offering a lower barrier to innovation compared with developed markets. The primary role of technology will be twofold, says the report. It can extend the 'hospital ecosystem' across the continuum of care from early diagnosis and surgical intervention to postoperative monitoring. It can also ensure products and solutions are robust, usable and affordable - and unlock access to care.The workshop delegates predict that patient expectations and hospital ecosystems in emerging markets will dramatically evolve and, in some cases, leapfrog developed markets. Even today, some hospitals in India have better outcomes for cardiac surgery than top hospitals in the US or UK. And top-tier hospitals in China are now being designed to be eco-friendly, sensor-rich and cloud-connected. "Emerging markets will play a significant role in transforming our industry," said workshop delegate Agustin Zabulanes, Latin America marketing manager at Boston Scientific. "Local emerging market companies may provide stiff competition to multinational companies - but they may also prove to be powerful partners in global surgical care. Success will require industry players to evolve the way they do business, organise for innovation and use enabling technology." The report says 'reverse innovation' offers developed markets the opportunity to benefit from emerging markets by learning new approaches to achieving healthcare affordability and efficiency - with lasting transformation coming from integrating new business models and innovation models. "As organisations evolve and succeed, innovating for emerging markets will enable industry to disrupt and transform how surgical care is delivered globally," said Sathe.   ]]> https://biospectrumindia.com/news/97/7692/cuddle-for-imports-hurdles-for-exports-.html https://biospectrumindia.com/news/97/7692/cuddle-for-imports-hurdles-for-exports-.html Wed, 17 Aug 2016 11:52:33 +0530 At a time when every country on this planet is pushing and facilitating their exports and encouraging domestic industry, Ministry of Health and Family Welfare's strange reluctance to issue 'Free Sale Certificate' to domestically manufactured medical devices for the purpose of exports despite competent certifications being held by bonafide exporters and recommendations by Ministry of Commerce and DGFT has created a major roadblock for the Indian exports and domestic medical device industry. MoH&FW's stance and attitude is even more perplexing and inexplicable when imports are being given a free run even as PM Modi is un relentlessly pursuing the 'Make in India' dream to encourage domestic manufacturing and increasing India's exports of hi-value products. "It is very unfortunate that our own MoH&FW has become India's biggest non-tariff barrier for Indian exports while laying zero non-tariff barrier for market access by importers and foreign manufacturers," lamented Mr Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Manufacturers. "Lack of availability of Free Sales Certification has resulted in lost opportunity and lost of face as manufacturers are losing their face after evoking the interest and expectations of the overseas distributors wishing to procure Indian medical devices. This is embarrassing .The myopic stance of MoH&FW is all the more perplexing at a time when PM Modi in unrelentlessely pursuing 'Make in India' dream and trying to galvanize Indian exports of high value products," added Rajiv Nath. Also read: Cipla announces changes in management team   It may be known that to export medical devices manufacturers need to take registration with foreign countries and seek approval from their regulatory authorities for permitting import of medical devices into that Country. The regulatory authorities usually ask for a 'Free Sales Certificate' from the country of origin. The intent being that if a product is freely sold within the country of origin and safe for the people of that country, then it would also be acceptable for the importing country. Typically, medical devices regulatory authorities desire this Free Sales Certificate to be issued by Ministry of Health or the Regulatory Authority of the exporting country. However, due to legacy regulatory and policy overhang, to which AiMeD has been constantly been drawing attention to, medical devices are categorized as drugs and the Free Sale Certificate in India is issued only for the 15 medical devices notified as Drugs by the State Drug Authorities with a validity of two Years. But for the rest of thousands of medical devices which are not yet covered in Regulations , the Free Sales Certificate is currently issued by DGFT (Directorate General of Foreign Trade) as in the case of consumer goods and engineering items. Many countries especially China, South & Central America are not satisfied with the certification issued by DGFT and insist on certification by MoH if it's a medical device. In the absence of such certification, they do not permit registration to enable the Indian Manufacturers to enter and sell in their domestic market. A proposal to overcome this issue (considering absence of independent Medical Device Regulation) was made to MoH&FW / CDSCO to endorse the Certificate of DGFT which may satisfy the importing countries registration approving authorities on the basis of submission of an IS/ISO: 13485 certification by the manufacturer. In a meeting taken by the Jt Secy, MOH on 05.12.2015, it was mooted by AiMeD to MoH&FW to create an online registration for all manufacturers of medical devices (even if not regulated) which will enable Government of India to have a registry of all Indian manufacturers of medical devices whether regulated or not to enable MoH to have a dialogue with the manufacturers which is necessary for capacity building considering the inevitable regulatory framework, sooner or later. Based on the registration in database and on request of the manufacturers and exporters the Free Sales Certificate of DGFT could be endorsed by MoH at least for those manufacturers who have an IS / ISO 13485 Certification. But till date, MoH &FW/DGHS/CDSCO haves shown remarkable reluctance to endorse this simple and workable idea. India exports $1.2 Billion of Medical Devices and Imports $3.5 billion of medical devices.   ]]> https://biospectrumindia.com/news/97/7996/medtronic-launch-new-insulin-pump-in-the-us.html https://biospectrumindia.com/news/97/7996/medtronic-launch-new-insulin-pump-in-the-us.html Fri, 12 Aug 2016 10:59:33 +0530 Medtronic plc announced the US commercial launch of its MiniMed 630G system with SmartGuard technology FDA approved for the treatment of people with diabetes mellitus sixteen years of age and older. The MiniMed 630G features a new insulin pump hardware platform and new user-friendly design that combines personalized diabetes management with industry-leading clinical performance. The MiniMed 630G system is the newest member of the MiniMed family-the most prescribed integrated insulin delivery system brand in the world. Also read: Medtronic strengthens commitment to Asia Pacific The MiniMed 630G system exclusively uses the CONTOURNEXT LINK 2.4 blood glucose meter from Ascensia Diabetes Care to provide blood glucose test results that have been shown to be highly accurate. The meter automatically transmits blood glucose results to calculate boluses using the Bolus Wizard calculator and to calibrate the CGM sensor, which helps prevent manual entry errors. It also allows patients to discreetly give themselves a bolus of insulin remotely from the meter, providing added convenience to help patients manage their diabetes effectively. "This latest innovation demonstrates Medtronic's vision to transform diabetes care to enable greater freedom and better health through a commitment to continually improving both outcomes and user experience," said Alejandro Galindo, president of the Intensive Insulin Management business at Medtronic.   The MiniMed 630G system combines its proprietary SmartGuard technology featured in the MiniMed 530G system with a brand new user-friendly design. The new pump platform fully integrates continuous glucose monitoring (CGM) and SmartGuard technology, which is designed to trigger an alarm when the CGM sensor glucose level reaches a preset low threshold and suspends insulin delivery if the user is unresponsive to the alarm. SmartGuard technology is the only feature available in the U.S. that takes action against lows, and is the only system proven to reduce the frequency of nighttime low episodes3 by a third.       ]]> https://biospectrumindia.com/features/97/7882/atrial-fibrillation-market-to-peak-in-2022-before-rapid-decline-to-4-9-bn-by-2025.html https://biospectrumindia.com/features/97/7882/atrial-fibrillation-market-to-peak-in-2022-before-rapid-decline-to-4-9-bn-by-2025.html Thu, 11 Aug 2016 15:26:02 +0530 The atrial fibrillation market will expand from approximately $8 billion in 2015 to hit its peak of $11.8 billion in 2022, after which the impact of patent expiries will see the market value fall rapidly to $4.9 billion by 2025, according to research and consulting firm GlobalData. The company's latest report states that the market, which covers the eight major markets (8MM) of the US, France, Germany, Italy, Spain, UK, Japan, and Canada, will decline after 2022 due to the entry of the first generics of the new oral anticoagulants (NOACs), starting with Boehringer Ingelheim's anticipated loss of US, Japanese, and Canadian patent protection for Pradaxa in 2018. Dr Jesus Cuaron, GlobaData's Senior Analyst covering Cardiovascular and Metabolic Disorders, explains: "Since the launch of the first NOACs in 2010, this drug class has experienced substantial uptake, accounting for $6.8 billion, approximately 85% of all atrial fibrillation sales revenue across the 8MM in 2015. This uptake will continue to increase, and will be the main driver of growth in the atrial fibrillation space through 2022. "This growth will be driven further by the launch of a fourth NOAC, Daiichi-Sankyo's Savaysa, which was first approved in Japan for stoke prevention in patients with atrial fibrillation in 2014. The continued uptake of such NOACs, along with the approval and launch of the first NOAC reversal agents for use in the event of uncontrolled bleeding, will contribute to initial market growth." Also read: India's medical devices market will hit $17.6 bn by 2020: GlobalData  However, GlobalData believes that a number of major barriers will hinder the growth of the atrial fibrillation space, including the generic erosion of multiple NOACs across the 8MM by 2023, and the large, costly, and comprehensive clinical trials required to support regulatory approval of novel antiarrhythmic drugs. Dr Cuaron concludes: "These factors will deter drug developers seeking to enter the atrial fibrillation market, and the wide availability of generic antiarrhythmic drugs, which will make it difficult for any novel rhythm control agents to gain reimbursement and wider uptake." ]]> https://biospectrumindia.com/features/97/7869/china-india-to-drive-global-central-vascular-access-devices-market-to-2-3-bn-by-2022.html https://biospectrumindia.com/features/97/7869/china-india-to-drive-global-central-vascular-access-devices-market-to-2-3-bn-by-2022.html Thu, 11 Aug 2016 15:24:06 +0530 The central vascular access devices market is set to experience relatively modest growth from around $1.9 billion in 2015 to just over $2.3 billion by 2022, representing a Compound Annual Growth Rate (CAGR) of 2.6%, according to research and consulting firm GlobalData. The company's latest report states that this growth, which will occur across the 10 major markets (10MM) of US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India, will be driven by a number of factors such as increases in the number of people in the treatment pool across the majority of the 10MM, high growth in central catheter placement, and healthcare providers in areas such as China and India seeking to match treatment regimens in leading markets. Also Read: India's pharma market to skyrocket from $20 bn in 2015 to $55 bn by 2020 Vascular access device is a broad term given to a range of instruments used to aid medical therapies. These instruments most commonly come in the form of thin and flexible catheters that are designed to intravenously deliver medication, nutrition, and fluids, and withdraw blood samples for further testing from large veins. Mr Amen Sanghera, MSc, GlobalData's Analyst covering Medical Devices, states that: "China and India will be responsible for a substantial proportion of the vascular access devices market growth over the forecast period, with CAGRs of 4.4% and 2.2% respectively. The European market, however, will see slow growth, with all five European countries registering CAGRs of less than 1%.   "Developing nations are growing in financial power and population size, and these two countries are destined to become financial superpowers in the future, which would enable them to provide healthcare that rivals that of the western world." In addition to growing financial power, the developing world will also see its vascular access devices space driven by an increase in major cancers. Indeed, as the developing world adopts Western lifestyles, they are also starting to inherit the caveats of that lifestyle, which include high-calorie diets, high tobacco consumption, and physical inactivity. This has resulted in the prevalence of lung and colon cancer in some countries, with incidences of lung cancer in China surpassing that of the US. Mr Sangera concludes: "Although China and India will increase their respective shares of the central vascular access devices market over the forecast period, the US will continue to dominate, with its share slipping slightly from 40.7% in 2015 to 39.0% by 2022. Indeed, increasing health burdens in the region will ensure steady growth to 2022."   ]]> https://biospectrumindia.com/news/97/7860/illumina-flowjo-to-develop-software-solution-for-single-cell-genomics-.html https://biospectrumindia.com/news/97/7860/illumina-flowjo-to-develop-software-solution-for-single-cell-genomics-.html Thu, 11 Aug 2016 12:13:55 +0530 Illumina, Inc. and FlowJo, LLC, has announced a partnership to develop and co-market analysis software for single cell next-generation sequencing (NGS) data. Under the agreement FlowJo, LLC, the producer of FlowJo, market-leading software for single cell analysis, will develop a new software application. It will provide additional secondary and tertiary analysis and visualization of datasets with an intuitive approach built on 19 years of experience working with cell biologists and immunologists in single cell phenotyping. The application will seamlessly integrate with Illumina's Single Cell RNA BaseSpace app, and provide a solution accelerating discovery. Also read: Illumina files patent infringement suit against Genoma SA "We are excited to partner with Illumina on this project to bring new tools for analyzing and visualizing NGS data to cell biology," said Dr Michael Stadnisky, CEO of FlowJo, LLC. "The new offering will enhance the power of single cell biology research by empowering robust exploration of data from Illumina next-generation sequencing runs." "FlowJo, LLC is recognized for delivering reliable, high-quality and easy-to-use software solutions that allow cell biologists to study phenotype in individual cells by flow cytometry," said Rob Brainin, Vice President and General Manager, Applied Genomics at Illumina. "We look forward to enabling our customers to bring these trusted FlowJo analytical capabilities to their next-generation sequencing data."   The software will complement the end-to-end commercial solution for high-throughput sequencing of single cells that Illumina announced it is co-developing in partnership with Bio-Rad Laboratories, Inc. The companies expect the software to be available in Q1 2017.   ]]> https://biospectrumindia.com/news/97/7693/bactiguard-holding-ab-to-provide-catheters-to-india.html https://biospectrumindia.com/news/97/7693/bactiguard-holding-ab-to-provide-catheters-to-india.html Wed, 10 Aug 2016 14:14:26 +0530 Bactiguard has received a new order from India of some 60 000 Foley catheters for infection prevention. The initial order from India, which was received in December 2015, consisted of some 50 000 Foley catheters for infection prevention (BIP Foleys). The new order consists of some 60 000 BIP Foleys and will generate direct sales revenues of approximately 2 million SEK at product delivery. Also read: Govt. push for indigenous medical devices "Sales and marketing activities in India are ongoing with a high level of intensity. There is a major need for infection prevention, as the level of multi resistant bacteria is high. Our products are now reaching hospitals and patients, where they are put to good use. As deliveries to dealers and hospitals are increasing, our distributor needs to restock its inventory, which is encouraging", says Cecilia Edström, Vice President Sales & New Business.     ]]> https://biospectrumindia.com/news/97/7621/medtronic-receives-ce-mark-for-suretune2-for-dbs-therapy.html https://biospectrumindia.com/news/97/7621/medtronic-receives-ce-mark-for-suretune2-for-dbs-therapy.html Wed, 10 Aug 2016 12:01:02 +0530 Medtronic has announced it has received CE (Conformité Européenne) Mark for SureTune2 software, which provides patient-specific visualization to help physicians make decisions on how to program - or tune - their patient's deep brain stimulation (DBS) therapy. SureTune2 is currently not approved in the United States. DBS therapy applies mild electrical stimulation to precise targets in the brain in order to modulate specific symptom control. The brain targets are stimulated through lead(s) inserted into the brain and connected to an implantable neurostimulator through extensions running under the skin. A medical professional uses an external programmer to set and adjust stimulation settings. Also read: FDA approves Medtronic's deep brain stimulation Today DBS patient programming can be an interactive process, which can be time- consuming for the hospital and the patient. SureTune2 is designed for Medtronic DBS therapy and other DBS therapy delivery systems to help physicians more efficiently select the optimal stimulation settings on their programmer by visualizing patient-specific information in one comprehensive view including anatomy, physiology, and calculated stimulation field. Users can segment structures using a greyscale threshold within a region of interest, or by outlining shapes of interest from a patient image. "Medtronic is committed to providing advanced technology to the multidisciplinary teams who are helping DBS patients, and I'm convinced that SureTune will provide them with easy-to-use tools to aid in optimizing therapy outcomes," said Dr Lothar Krinke, vice president and general manager of the Brain Modulation business in Medtronic's Restorative Therapies Group. "SureTune is a key aspect of Medtronic's commitment to providing integrated solutions for improving accuracy and confidence from surgery to post-operative DBS patient management."   ]]> https://biospectrumindia.com/news/97/8420/indian-govt-relaxes-clinical-trial-norms.html https://biospectrumindia.com/news/97/8420/indian-govt-relaxes-clinical-trial-norms.html Tue, 09 Aug 2016 15:29:00 +0530 In a bid to woo global researchers and improve the clinical trial landscape in the country, the Indian government has decided to relax rules and ease clinical trial procedures in India. The apex body to control clinical trials and drug quality issues, the Drug Controller General of India (DCGI), has amended some critical clauses, a move, that is expected to boost clinical trials in India. Under the new norm, a clinical researcher will be allowed to perform as many trials as approved by the ethics committee, instead of the previous cap of three trials. Restrictions on number of minimum beds at the clinical trial site have also been removed. Earlier, the clinical trial site was mandated to have at least 50 beds. The drug makers also need not take 'no objection certificate' from the DCGI in case of addition or deletion of new clinical trial site or investigator. The new rules were notified by the Central Drugs Standard Control Organisation (CDSCO) of India under Ministry of Health and family Welfare recently. Also read: Mylan completes acquisition of Meda Dr G N Singh, Drug Controller General of India (DCGI), said that the decisions were taken over two meetings held with all stakeholders recently. "The idea is to create conducive environment for the pharma sector to enter swiftly into drug discovery and research phase," he added. "It has been decided to revise the condition that no clinical trial shall be conducted at a hospital having less than 50 beds. It has further been decided that an Ethics Committee shall examine and decide whether the clinical trial site is suitable for trial or not, irrespective of the number of beds," said Dr Singh.   Dr Singh further highlighted that the relaxed norms will help India register its presence in the international market as it will give Indian scientists and doctors the much needed liberty. With relaxed norms we will give more research opportunities to our scientists, he said. According to the Central Drugs Standard Control Organisation (CDSCO), around 65 trials were approved in 2008, whereas it jumped to 391 in 2009, and 500 in 2010. However, following the Supreme Court's intervention, the approvals dropped drastically from 2011 onwards, reported a leading daily. ]]> https://biospectrumindia.com/news/97/7373/siemens-launches-mid-volume-coagulation-analyzer-.html https://biospectrumindia.com/news/97/7373/siemens-launches-mid-volume-coagulation-analyzer-.html Tue, 09 Aug 2016 11:57:13 +0530 Siemens Healthineers Laboratory Diagnostics business launched the Sysmex CS-2500 System-a mid-volume, fully-automated coagulation analyzer with smartly-designed PSI technology-in major markets including the US. Together with Lab Alliance of Central New York, the first US customer to install the high-volume Sysmex CS-5100 System, the company celebrated the availability of its new Sysmex CS Hemostasis System portfo-lio in the US. The launch of the new Sysmex CS-2500 System will enable mid-volume laboratories to leverage globally-proven PSI technology, while providing regional reference laboratories and integrated delivery networks (IDNs) with the ability to standardize testing results across multiple Sysmex CS and CA hemostasis systems. "Labs today are challenged to increase their output without sacrificing the accuracy or reliability of their results. The Sysmex CS Systems are the answer to this demand," said Franz Walt, President, Laboratory Diagnostics, Siemens Healthineers. "The increased op-erational efficiency and uninterrupted workflow delivered by the Sysmex CS-5100 and CS-2500 Systems provide our customers with the confidence, consistency and increased capacity they need to deliver timely and accurate hemostasis test results." Also read: Siemens' new high-volume coagulation analyzer In most markets, the Sysmex CS-2500 System features simultaneous multiwavelength scanning and proven PSI technologies including primary-tube sample-volume checks, clog detection, assay-based preanalytical sample-quality checks for hemolysis, icterus and lipemia (HIL) interference; automated mixing studies; automated platelet aggrega-tion; and clot waveform analysis (CWA)-enabling labs to raise the quality of test re-sults, achieve cost-effective method consolidation, simplify operations, and increase diag-nostic confidence.   The new system enhances efficiency via a wide optical spectrum, which allows clotting, chromogenic, immunologic and aggregation testing capabilities on a single platform. With an onboard capacity of up to 3,000 tests and up to 40 reagents, the Sysmex CS-2500 System delivers extended walkaway time to streamline workflow. Anne Chamberlain, Hematology Manager at Laboratory Alliance of Central New York, remarked, "The Sysmex CS Systems and the services offered by Siemens Healthineers are the perfect fit for our laboratory and laboratory networks similar to ours. The intuitive system software, readily accessible patient analysis data and result traceability simplifies our operations. This enables our lab to deliver quality test results, which positively impacts patient care for our clients." To help labs ensure consistency and improve productivity, the systems use the same rea-gents, controls and calibrators as other coagulation analyzers offered by Siemens Healthi-neers.   ]]> https://biospectrumindia.com/news/97/7350/govt-push-for-indigenous-medical-devices-.html https://biospectrumindia.com/news/97/7350/govt-push-for-indigenous-medical-devices-.html Tue, 09 Aug 2016 11:56:51 +0530 AIMED has warmly welcomed the advisory issued by the Ministry of Health and Family Welfare, Government of India, to all State Governments and Central Health Agencies to include and encourage domestic standards for procurement of medical devices in tender specifications by various health agencies. On behalf of Ministry, Additional Secretary Shri K B Agarwal recently issued an advisory to all State governments and Central Health Agencies to include CDSCO approved medical devices for being considered for procurement of medical device and desist from insistence of USFDA approvals. Also read: Indian Certification of Medical Devices Scheme launched The advisory is being seen by the industry as a much needed move to usher in price parity and create a level playing field between domestically produced medical devices and imports while catalyzing Prime Minister Narendra Modi's vision of 'Make in India', galvanizing domestic manufacturing, reduce humungous import dependency and bring down overall healthcare cost for common citizens. "We are hugely delighted and absolutely thankful to the Ministry of Health and Family Welfare and Shri Agarwal for this much needed and timely advisory. Medical device sector is one of the corner stone of PM Modi's 'Make in India' Vision. This advisory will help create a level playing field between domestically produced medical devices and imports. If implemented in right spirit by all states, this will catalyze domestic manufacturing and boost up demand for India manufactured goods while bringing down overall healthcare cost," said Mr Rajiv Nath, Forum Coordinator, AIMED. It may be known that due to legacy reasons and blind imitations, tenders by Central and State health agencies have typically insisted on USFDA certifications to qualify for the same, thus creating a big disadvantage for domestic manufacturers. The tenders often do not even consider alternative options such as ISO 13485 Certification. This resulted in as the ministry's advisory states "denial of fair chance to the domestic manufacturers to compete in such procurements." The advisory also states that "such practice not only impedes competition, but also affects the 'Make in India' effort.   The insistence of USFDA Certification by reputed Central and State government health institutions had seriously undermined the credibility of our own Regulators. No other country in the world insists on only one certification source and that also USA FDA exclusively. All major countries have their own domestic or alternate international certification e.g. Canada has CDMAS, Australia has TGA and Europe has CE. India too have very competent manufacturers with CDSCO mfg license or European Certification of CE Mark or with credible ISO 13485 certification and the recently introduced ICMED 13485 certification by QCI . But strangely most public health and even Defence ministry tendering had insisted on USFDA certifications as being mandatory. "Insistence on the 'Exclusionary USFDA Certification' requirement for technical bid is a grossly discriminatory practice as it only favours large US companies in domestic public healthcare procurement process. This insistence is a pure absurdity and has resulted in exclusion of Indian manufacturers from even having access to our own Indian market and even disallowed manufacturers from other countries from bidding and thereby hiking up the healthcare costs," says Mr Nath. The ministry's advisory has recommended that "the States/UTs may (i) advise all concerned to ensure that in all proposals relating to procurement, CDSCO approved medical devices should invariably be indicated as a category in the tender documents for procurement, and (ii) the technical specifications designed by the Ministry of Health and Family Welfare and NHSRC may as far as possible be used for all procurements in future to ensure uniformity." AIMED had for long been drawing attention of the government and other stakeholder to this lacunae which had put domestic manufacturers at a big disadvantage. It is happy to note that its long efforts have borne fruit.     ]]> https://biospectrumindia.com/news/97/7029/iscr-welcomes-cdsco-restrictions-on-investigators-sites.html https://biospectrumindia.com/news/97/7029/iscr-welcomes-cdsco-restrictions-on-investigators-sites.html Mon, 08 Aug 2016 12:51:40 +0530 Welcoming the recent announcements by the DCGI with regard to the cap on the number of trials per investigator and number of beds per site, the Indian Society for Clinical Research (ISCR) has said that it is a welcome move that will enhance the overall quality of clinical research being done in India. ISCR also acknowledged the collaborative approach by the regulators in making the changes in response to stakeholder feedback. On August 2, 2016, CDSCO released two circulars by the DCGI regarding the conduct of clinical trials in India. As per the revised rules, the cap on the number of trials an investigator can undertake at any point in time has been removed and the Ethics Committees have ben empowered to decide on how many trials an investigator can undertake after examining the risk and complexity involved in the trials being conducted. The cap on a minimum number of 50 beds for a clinical trial site has also been revised with the Ethics Committees now being vested with the responsibility of examining and deciding whether a clinical trial site is suitable for a trial or not, irrespective of the number of beds.   "The earlier restrictions impacted a sponsor's ability to choose the best qualified investigators and sites for a study. Every investigator and site is unique in terms of their capacity, capability and infrastructure and, therefore, their ability to do quality clinical research. The new announcements vest this decision with the Ethics Committees who are best positioned to deliberate on this and take a well calculated decision. This is something we at ISCR have been making submissions on behalf of all the clinical research stakeholders we represent and we are pleased that the regulators have responded positively to stakeholder feedback," said Ms Suneela Thatte, President, ISCR. "Ultimately what this translates into is qualitatively better clinical trials as decisions will be guided by which investigator or site is best suited for a particular trial and not by any arbitrary limits." ISCR also acknowledged the efforts and contribution of late Prof Ranjit Roy Chaudhury, who headed the Expert Committee constituted by the Ministry of Health & Family Welfare in February 2013 to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. One of the recommendations in a report by the Executive Committee submitted to the government was that any clinical trial of a new or existing drug or medical device should be carried out at a centre where facilities for carrying out such trials exist, and the investigators carrying out the trial are competent and have experience in the successful conduct of such trials. The Committee also recommended that the decision regarding the number of clinical trials a Principal Investigators can undertake should be taken by the Principal Investigators and the Institute Ethics Committee. Acknowledging the contribution of late Prof Chaudhury, Suneela Thatte said, "Late Prof Chaudhury's recommendations paved the way for many of the regulatory reforms we have seen in India and we would like to place on record once again his immense contribution to the development of clinical research in India."   ]]> https://biospectrumindia.com/news/97/6859/quintiles-davita-clinical-research-announce-strategic-alliance-.html https://biospectrumindia.com/news/97/6859/quintiles-davita-clinical-research-announce-strategic-alliance-.html Fri, 05 Aug 2016 16:14:14 +0530 Quintiles, and DaVita Clinical Research, a wholly-owned subsidiary of DaVita HealthCare Partners Inc., a leader in kidney care, has announced a global strategic alliance. The alliance combines DaVita's clinical care and expansive footprint of research sites with Quintiles' operational delivery and therapeutic expertise in clinical trials. "Through this alliance with DaVita Clinical Research, we will have the power to provide biopharmaceutical customers with nephrology expertise and global delivery capabilities to truly advance clinical research," said Jeanne Hecht, senior vice president and global head, Site and Patient Networks at Quintiles. "Our aim is to align our processes to reduce cycle times and accelerate clinical trial execution. Moreover, we will be able to alleviate the burden on patients participating in renal disease trials by incorporating clinical research into clinical care." DaVita Clinical Research brings to this alliance data-driven trial feasibility expertise, trial sites in Europe and Latin America, its deep clinical knowledge of renal patients as well as an established research infrastructure with DaVita dialysis facilities and 30 years' experience conducting clinical trials across therapeutic areas. Through this strategic alliance, the two companies align to provide capabilities and solutions for overcoming these challenges to deliver end-to-end support for renal disease clinical trials. By leveraging Quintiles' protocol modeling and feasibility, in combination with DaVita's extensive patient understanding, biopharmaceutical customers will be able to take advantage of the combined assets of both companies to progress their clinical programs. "This alliance allows novel approaches to clinical development and clinical trial execution specifically in site identification, participant enrollment and study design," said Amy Young, vice president and general manager of DaVita Clinical Research. "We are excited about the opportunities this affords our organizations to provide innovative solutions to the biopharmaceutical industry and the participants we serve."   ]]> https://biospectrumindia.com/news/97/7785/iscr-welcomes-cdsco-circular-on-investigators-sites.html https://biospectrumindia.com/news/97/7785/iscr-welcomes-cdsco-circular-on-investigators-sites.html Fri, 05 Aug 2016 11:00:40 +0530 Welcoming the recent announcements by the DCGI with regard to the cap on the number of trials per investigator and number of beds per site, the Indian Society for Clinical Research (ISCR) has said that it is a welcome move that will enhance the overall quality of clinical research being done in India. ISCR also acknowledged the collaborative approach by the regulators in making the changes in response to stakeholder feedback. On August 2, 2016, CDSCO released two circulars by the DCGI regarding the conduct of clinical trials. As per the revised rules, the cap on the number of trials an investigator can undertake at any point in time has been removed and the Ethics Committees have ben empowered to decide on how many trials an investigator can undertake after examining the risk and complexity involved in the trials being conducted. The cap on a minimum number of 50 beds for a clinical trial site has also been revised with the Ethics Committees now being vested with the responsibility of examining and deciding whether a clinical trial site is suitable for a trial or not, irrespective of the number of beds. "The earlier restrictions impacted a sponsor's ability to choose the best qualified investigators and sites for a study. Every investigator and site is unique in terms of their capacity, capability and infrastructure and, therefore, their ability to do quality clinical research. The new announcements vest this decision with the Ethics Committees who are best positioned to deliberate on this and take a well calculated decision. This is something we at ISCR have been making submissions on on behalf of all the clinical research stakeholders we represent and we are pleased that the regulators have responded positively to stakeholder feedback," said Suneela Thatte, President, ISCR. "Ultimately what this translates into is qualitatively better clinical trials as decisions will be guided by which investigator or site is best suited for a particular trial and not by any arbitrary limits." ISCR also acknowledged the efforts and contribution of late Prof. Ranjit Roy Chaudhury, who headed the Expert Committee constituted by the Ministry of Health & Family Welfare in February 2013 to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. One of the recommendations in a report by the Executive Committee submitted to the government was that any clinical trial of a new or existing drug or medical device should be carried out at a centre where facilities for carrying out such trials exist, and the investigators carrying out the trial are competent and have experience in the successful conduct of such trials. The Committee also recommended that the decision regarding the number of clinical trials a Principal Investigators can undertake should be taken by the Principal Investigators and the Institute Ethics Committee. Acknowledging the contribution of late Prof. Chaudhury, Suneela Thatte said, "Late Prof Chaudhury's recommendations paved the way for many of the regulatory reforms we have seen in India and we would like to place on record once again his immense contribution to the development of clinical research in India."   ]]> https://biospectrumindia.com/interviews/97/8409/the-sound-of-hearing.html https://biospectrumindia.com/interviews/97/8409/the-sound-of-hearing.html Thu, 04 Aug 2016 18:09:46 +0530 In 2009, IITians Mr Patel and Mr Anurag Sharma together co-founded Quadio Devices in Pune. Hearing loss in India is largely unaddressed and the existing hearing health facilities are scarce and unaffordable for many. Quadio aims to bridge this gap by empowering people by providing accessible and affordable hearing care solutions, from hearing aids to portable diagnostics. Recently, the company launched its indigenously developed India's first hearing app, Q+, a smartphone app which converts a contemporary smartphone into hearing aids by harnessing the phone's processing power, microphone and wired headsets for delivering sound to the user. BioSpectrum caught up with Quadio's CEO Mr Neeraj Dotel, who shares the company's vision and strategy in making hearing solutions affordable to the common man and Quadio's innovations in the pipeline. Edited excerpts:Q: Tell us about Quadio's recent innovations. A: Initially, we started making hearing aids but then we soon realized that the real challenge was accessibility. The company then started developing Net Dispensing, a solution built around internet and mobile technologies with a goal to improve the accessibility, affordability and adoption of hearing solutions.   We recently launched India's first hearing app, Q+, which comes with an inbuilt hearing test and automatic sound enhancement based on the user's hearing loss. Quadio's hearing solutions -- hearing aids and apps -- for individuals are do-it-yourself (DIY), programmable, personalizable and rechargeable, thus making them easy-to-use and low on maintenance. For hearing health solutions, Quadio dovetails internet and mobile technologies to connect its highly qualified pool of audiologists to the last mile point-of-care, thereby pushing the boundaries of telemedicine and hearing care. Q: What trends are impacting the global hearing solutions space? A: Globally, there is an increased awareness about the numerous medical, social and psychological consequences of untreated hearing loss. In India, however, the awareness remains extremely low. Earlier this was presumed to be an age-related impairment, but hearing loss is beginning to affect young adults due to lifestyle changes, such as excessive use of headphones for long periods on personal devices, and increased noise pollution. According to a 2015 report by World Health Organization (WHO), over 1.1 billion young adults are at risk of hearing loss. In terms of trends, consumers are rapidly moving towards pre-programmed and customizable devices that give greater control on hearing experiences. Increasingly people are buying hearing solutions over the internet in the US and Europe, since there are various affordable options available at the click of a button. Q: What is your business model? A: Quadio's business model centers on traditional hearing aids, services, and mobile and internet-based solutions. Q: What's the market size for hearing solutions in India? A: The market for hearing aid products is over Rs 350 crore and growing at 15 to 20 percent per year. However, the market size has nothing to do with market potential. WHO data states that only 1.4 percent of affected people actually use hearing devices in India as opposed to 20 to 30 percent in developed countries. Quadio aims to massively increase penetration of low-cost assisted hearing in India. Q: What's your market share in the country? A: Our growth has taken off after introducing net dispensing (telemedicine) and the Q+ app. Both of these will disrupt the hearing industry as it will be no longer necessary to rely on brick-and-mortar infrastructure to find and provide service to customers. In the coming three years we aim to be amongst the top hearing care providers in the country. Q: What are the top growth drivers for Quadio? A: Our biggest growth driver is the Q+ hearing app which can be downloaded by anyone who needs hearing care. People who need advanced diagnostics opt for our net dispensing solutions (telemedicine) that provides easy accessibility to professional hearing care from anywhere in the country through our partners like hospitals, ENT surgeons, NGOs and social organizations. Net dispensing is a proprietary solution that converts any point of care to a virtual hearing clinic. Q: What are the mammoth challenges in the Indian market? A: The biggest challenge is awareness and access to affordable hearing care. This is followed by lack of adoption for assisted hearing due to social stigma. Most people aren't aware that hearing starts degrading with age, with lifestyle preferences along with work hazards adding to it on a regular basis. Educating everybody about this is really important as hearing loss leads to depression, dementia, cognitive decline, physical injuries, Alzheimer's disease and even mortality. India also doesn't have enough number of practicing audiologists. The country has only 2000 for a population of 1.2 billion. The few practicing audiologists that we have are mostly situated in the tier 1 and 2 cities, leaving the large rural population without much options. Besides this, a good pair of hearing devices cost upwards of Rs 40,000 for each ear, thus putting it out of reach for the common man. Q: What's unique about Q+ app, though we have other apps in the same space? A: Q+ app has the following features that differentiate it from the other apps available in the market:  Inbuilt hearing tests calibrated for precision per ANSI standards Intelligently-adjusted sound per hearing test results High-quality sound enhancement by using the same algorithms as hearing aids Wide bandwidth - up to 8250 Hz - for improved comprehension and clarity of sound Automatic adjustment of amplification to reduce feedback (whistling sound) Versatile controls for customizing listening experiences Environmental noise reduction Most free apps only amplify sounds while Q+ app is designed to reduce feedback and background noise. It also provides a wider sound bandwidth. Q: How do you address a price-sensitive market like India? A: By giving a hearing aid that is free on a smart phone! Our Q+ app can work very well for an individual who suffers from mild to severe hearing loss. The Lite version of this app is free for download and the Pro version will be available for a one-time fee of Rs 500. The app is compatible on both iOS 8 and above, and Android 5 and above platforms, and hence will drastically lower the price points for hearing mechanisms in India. Our traditional hearing aids provide significant value for money in terms of features, customizability, and user control and are priced direct-to-customer. Q: What are the differences between Indian market and others when it comes to launching a new product? A: The stark differences are very visible in reach, awareness and affordability when introducing a new product. India is still a developing nation, and hence a considerable effort is required for any launch. Customization in regional languages is also a pre-requisite for the Indian market. Q: What partnerships are you looking out for? A: We are ready to partner with anyone looking to offer hearing care services with little or no upfront investment. We have partnered with hospitals, ENT surgeons, NGOs and eye care specialists to reach a large swathe of the population that needs hearing services. Q: About your clientele? A: Our clientele are customers who require hearing care at affordable prices. We also engage with health care providers who we operate with on revenue share to provide net dispensing and remote fitting of hearing aids. We are also working with heavy industries with loud factories to provide counselling around noise management as well as services for diagnostics and rehabilitation for employees. Q: Are you be open to M&As? A: We are not looking for M&As. However, any company we tie-up with has to be passionate about accessibility and affordability of hearing care. Q: To which cities or countries are you planning to expand? A: India is a huge market and we wish to increase the percentage of hearing solutions from 1 percent to 5 percent in the near future. The BRIC countries also have low penetration and Quadio plans to add value to these markets by providing them with high-quality Quadio hearing care services. The Q+ hearing app is a game changer in global markets, and we are seeing a lot of downloads in the US and Europe. We will be addressing those markets as well at the appropriate time. Q: How much do you invest in your R&D annually? A: We wouldn't like to share exact figures but would let you know that we invest heavily in R&D. Q: Where are your products designed and manufactured? A: Pune. Q: What'd be your revenue target for the next couple of years? A: We plan to be a Rs 3 crore company this year, and then continue to grow in multiples of that in the coming years. Q: What next for Quadio? A: We have some very interesting research and cool products that are not just for hearing impaired individuals but for anybody looking to have superior hearing experiences. ]]> https://biospectrumindia.com/news/97/6190/the-worlds-first-smart-insulin-pens-with-automatic-wireless-data-transfer-.html https://biospectrumindia.com/news/97/6190/the-worlds-first-smart-insulin-pens-with-automatic-wireless-data-transfer-.html Thu, 04 Aug 2016 16:56:00 +0530 Emperra GmbH based in Germany is launching the world's first Bluetooth insulin pen on the market and therefore expanding its ESYSTA product system's function. The new ESYSTA BT pen is equipped with a Bluetooth interface and transfers the injected insulin doses directly to the patient's digital blood glucose diary. The smart insulin pens automatically connected via the 868 MHz interface (similar to the ISM band) are already being successfully used in medicine in combination with a wireless transmission blood glucose meter as an integrated diabetes management system, ESYSTA. Both the hardware components and software solutions (ESYSTA portal, ESYSTA app) have been certified as CE-compliant medical products. Patients and doctors can achieve a new quality of medical care for Type 1 and Type 2 diabetics using the patented ESYSTA solution. On the basis of the available scientific data and reimbursement by statutory health insurance companies on the complex German healthcare market, Emperra is striving to use this smart insulin pen based ESYSTA telemonitoring solution with an FDA filing process for the US market. FDA clearance is expected in 2016. "The smart insulin pen and corresponding software appeal to patients and doctors who prefer state-of-the-art technical solutions and who have recognised that the digitalisation of diabetes management is a simple and reliable solution," summarises Dr. Christian Krey, CEO of Emperra GmbH. With the help of innovative sophisticated software solutions compliant with medical products and the highest integrated data security standards ISO/IEC 27001, several teams of doctors can even solve complex issues with patients whose levels are hard to adjust telemedically for the first time worldwide using unadulterated insulin data from insulin pens.   The mobile CE-compliant ESYSTA app for iOS and Android plays the treatment recommendations back, among other things using innovative traffic light algorithms.       ]]> https://biospectrumindia.com/news/97/8212/alere-inc-to-strengthen-its-footprint-in-apac.html https://biospectrumindia.com/news/97/8212/alere-inc-to-strengthen-its-footprint-in-apac.html Thu, 04 Aug 2016 12:13:57 +0530 Alere Medical Pvt. Ltd, the Indian subsidiary for the world's noted Point-Of-Care(POC) Diagnostics Company Alere Inc. announced the launch of its integrated facility in India for manufacturing POC diagnostic products. The Company intends to accelerate its export strategy in India, as part of an Asia-Pacific expansion plan, in order to meet the growing demand for rapid diagnostics in APAC Region. "Alere believes in Prime Minister Narendra Modi's vision of "Make in India," and is committed to improving access to affordable rapid diagnostics in India and throughout the Asia Pacific region through this new world-class manufacturing facility. The new factory will produce rapid tests for infectious diseases including Malaria, Dengue and HIV and export them across Asia Pacific, a region heavily impacted by these diseases," said Mr. Namal Nawana, CEO & President, Alere Inc. In sync with the 'Make In India' campaign, Alere's Indian subsidiary Alere Medical Pvt. Ltd has invested Rs 150 crores to set up a manufacturing facility in the country. The Manesar facility will initially produce more than 150 million rapid diagnostic tests per year and will have the capacity to expand to 300 Mn test over time. The facility is spread across 180,000 sq. ft. and will immediately generate 300 new jobs. Mr. Nawana further added, "Alere's new facility will support the goals of our 'Make in India' initiative, which seeks to transform India into a global manufacturing hub. Efforts to foster and expand India's medical device sector are important not only to our economic growth, but also to improve the health of the people of India.The new state-of-the-art facility will not only help us meet the needs of the burgeoning domestic market but also help us cater to the APAC market." Alere Inc aims to achieve their target of Rs. 1,000 crore over the next 3 years equipped with portfolio innovative POCT diagnostic products that will focus on improving health outcomes. The company will continue to focus on cardio metabolic diseases, infectious diseases and toxicology (Drugs of Abuse) solutions in India by providing affordable, sensitive, specific, user-friendly, devices for disease control & management.   ]]> https://biospectrumindia.com/news/97/8389/fujifilm-presents-latest-digital-radiography-innovations-at-ahra-2016-.html https://biospectrumindia.com/news/97/8389/fujifilm-presents-latest-digital-radiography-innovations-at-ahra-2016-.html Tue, 02 Aug 2016 11:27:00 +0530 FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging products and medical informatics solutions, will have a major presence at the American Healthcare Radiology Administrators (AHRA) annual meeting held July 31-August 3, 2016, at The Gaylord Opryland Resort & Convention Center in Nashville, TN. In addition to showcasing its comprehensive portfolio of digital radiography products and women's imaging solutions, Fujifilm will sponsor the keynote presentation on Tuesday, August 2nd as well as lead an educational symposium on DR and the impact of the Consolidated Appropriations Act of 2016 on Wednesday, August 3rd. "Our participation at AHRA 2016 will extend well beyond the walls of our booth, offering radiology professionals valuable information, insights and experience that they can take back to their facilities to improve department processes and patient outcomes," said Rob Fabrizio, director of strategic marketing, Digital Radiography and Women's Health, FUJIFILM Medical Systems U.S.A., Inc. Select highlights from Fujifilm's comprehensive DR portfolio include: FDR D-EVO GL - Begins shipping in the United States this month is the world's first long length DR detector. It is designed to acquire long-length radiography for scoliosis and/or long leg exams with a simple, low dose, fast, single exposure. Featuring a huge 17x49" field of view, the FDR D-EVO GL saves time, enhances efficiency, image quality and dose for upright long-length radiography exams. It simplifies long length exams reducing chances for patient movement artifacts with faster setup and less chance for anatomy cut off due to a wider field of view compared to conventional multi-exposure DR. Compared to CR, the detector uses less dose and eliminates CR reader processing steps. The wait for a single exposure long length DR is over and the benefits far exceed conventional solutions available.   Virtual Grid - Also releasing this month is Fujifilm's second generation grid simulation image processing. Virtual Grid intelligently interprets and corrects the effects of scatter radiation, adapting contrast to improve image quality for exams acquired without a grid. Virtual Grid brings valuable benefits to imaging, enhancing patient comfort; eliminating bulky grids, simplifying technologist productivity; making the detector lighter and faster to position, and lowering dose as much as 50% compared to exams performed with a grid. Virtual Grid can be used with both DR and CR, all anatomy, including long length images. Focus on Education Fujifilm's ongoing commitment to education will be evident at AHRA 2016. Fujifilm will sponsor the general session keynote speaker, Scott Steinberg, as he delivers his presentation, "Leading with Innovation: How to Future-Proof Yourself, Fearlessly Innovate, and Succeed in the New Normal." A celebrated speaker, author, futurist and strategic innovation consultant, Steinberg has earned a reputation for helping professionals and organizations cultivate competitive advantages. Fujifilm will deliver an educational symposium titled "Navigating the New Consolidated Appropriations Act of 2016: Challenging Problems...DR Solutions." Led by Rob Fabrizio the session will cover the business and reimbursement impact of the new legislation on radiology departments. The session will also explore the benefits of a CR-to-DR transition including a variety of improvements to the domains of care as well as a facility's bottom line. Attendees will have an opportunity to ask questions and will receive 1 ASRT approved credit.   ]]> https://biospectrumindia.com/news/97/5603/gsk-google-to-establish-bioelectronic-medicines-firm.html https://biospectrumindia.com/news/97/5603/gsk-google-to-establish-bioelectronic-medicines-firm.html Tue, 02 Aug 2016 11:26:52 +0530 GSK announced an agreement with Verily Life Sciences LLC (formerly Google Life Sciences), an Alphabet company, to form Galvani Bioelectronics to enable the research, development and commercialisation of bioelectronic medicines. GSK will hold a 55% equity interest in the new jointly owned company and Verily will hold 45%. Galvani Bioelectronics will be headquartered in the UK, with the parent companies contributing existing intellectual property rights[1] and an investment of up to £540 million over seven years, subject to successful completion of various discovery and development milestones. Bioelectronic medicine is a relatively new scientific field that aims to tackle a wide range of chronic diseases using miniaturised, implantable devices that can modify electrical signals that pass along nerves in the body, including irregular or altered impulses that occur in many illnesses. GSK has been active in this field since 2012 and believes certain chronic conditions such as arthritis, diabetes and asthma could potentially be treated using these devices. The agreement to establish Galvani Bioelectronics represents an important next step in GSK's bioelectronics research. The new company will bring together GSK's world class drug discovery and development expertise and deep understanding of disease biology with Verily's world leading technical expertise in the miniaturisation of low power electronics, device development, data analytics and software development for clinical applications. Initial work will centre on establishing clinical proofs of principle in inflammatory, metabolic and endocrine disorders, including type 2 diabetes, where substantial evidence already exists in animal models; and developing associated miniaturised, precision devices. Moncef Slaoui, GSK's Chairman of Global Vaccines, who was instrumental in establishing GSK's investments in the field of bioelectronics, will chair the board of the new company. He said:   "Many of the processes of the human body are controlled by electrical signals firing between the nervous system and the body's organs, which may become distorted in many chronic diseases. Bioelectronic medicine's vision is to employ the latest advances in biology and technology to interpret this electrical conversation and to correct the irregular patterns found in disease states, using miniaturised devices attached to individual nerves. If successful, this approach offers the potential for a new therapeutic modality alongside traditional medicines and vaccines. "This agreement with Verily to establish Galvani Bioelectronics signals a crucial step forward in GSK's bioelectronics journey, bringing together health and tech to realise a shared vision of miniaturised, precision electrical therapies. Together, we can rapidly accelerate the pace of progress in this exciting field, to develop innovative medicines that truly speak the electrical language of the body." Brian Otis, Verily's Chief Technology Officer, said: "This is an ambitious collaboration allowing GSK and Verily to combine forces and have a huge impact on an emerging field. Bioelectronic medicine is a new area of therapeutic exploration, and we know that success will require the confluence of deep disease biology expertise and new highly miniaturised technologies. "This partnership provides an opportunity to further Verily's mission by deploying our focused expertise in low power, miniaturised therapeutics and our data analytics engine to potentially address many disease areas with greater precision with the goal of improving outcomes." Galvani Bioelectronics will be headquartered within GSK's global R&D centre at Stevenage in the UK, with a second research hub at Verily's facilities in South San Francisco. It will initially employ around 30 expert scientists, engineers and clinicians, and will fund and integrate a broad range of collaborations with both parent companies, academia and other R&D companies. GSK and Verily believe this collaborative way of working will rapidly accelerate the development of bioelectronic medicines. Kris Famm, GSK's Vice President of Bioelectronics R&D, has been appointed President of the new company. Famm has pioneered work in both large and small molecule drug discovery and worked for a decade developing and delivering R&D strategy with a recurring focus on emerging technologies. He has co-designed and led GSK's exploration of bioelectronics. A seven-member board, chaired by Moncef Slaoui, will also be appointed and will include Andrew Conrad, CEO of Verily. The new company will be fully consolidated in GSK's financial statements. This agreement is subject to customary closing conditions (including requisite antitrust approvals) and is expected to close before the end of 2016.   ]]> https://biospectrumindia.com/news/97/7009/world-hepatitis-day-india-lagging-behind-in-hepatitis-research.html https://biospectrumindia.com/news/97/7009/world-hepatitis-day-india-lagging-behind-in-hepatitis-research.html Thu, 28 Jul 2016 12:42:09 +0530 World Hepatitis Day is observed on July 28 to raise global awareness of viral hepatitis (an inflammation of the liver caused by a virus), and to call for access to treatment, better prevention programs and government action. There are five different hepatitis viruses - Hepatitis A, B, C, D and E. This year, the theme for World Hepatitis Day is 'ELIMINATION' with ambitious targets by WHO member states and a goal to eliminate hepatitis as a public health threat by 2030. One of the five core intervention areas of the global elimination strategy is treatment including new, well-tolerated medicines and treatment regimens for people with chronic hepatitis virus infection. According to the Indian Society for Clinical Research, attainment of this goal requires scaling-up clinical research in hepatitis extensively, particularly in India which carries a high burden of hepatitis B and C. "Of the five different types of hepatitis, there is no cure for three of the types. Hepatitis C alone affects an estimated 12 million people in India, most of whom do not know that they have the disease. When you take into account the other types, the combined burden of viral hepatitis in India is high. Moreover, all types of hepatitis are contagious and some of them can be potentially life-threatening. Yet, despite the alarming statistics, we as a country have not undertaken enough clinical research in this area. We need treatment regimens that are short and therapies that are effective, affordable and well-tolerated," said Suneela Thatte, President, ISCR. India has 17 percent of the global population and 20 percent of the global disease burden but less than 1.4 percent of all global clinical trials are done in India.   "India was never a country that had a very high percentage of trials relative to the trials being done in the rest of the world nor is it our objective to be the number one country in the region or globally for doing trials. What is important is that the trials being done in India are significant enough to address our growing burden disease and the unique healthcare requirements of our country. People living with viral hepatitis have a right to safe, affordable and effective care and treatment," added Ms. Thatte.     ]]> https://biospectrumindia.com/news/97/8486/ge-acquires-biosafe-group-sa-.html https://biospectrumindia.com/news/97/8486/ge-acquires-biosafe-group-sa-.html Wed, 27 Jul 2016 11:33:25 +0530 GE Healthcare has acquired Biosafe Group SA, a supplier of integrated cell bioprocessing systems for the rapidly growing cell therapy and regenerative medicine industry for an undisclosed sum. The acquisition of Biosafe expands GE Healthcare's end-to-end ecosystem of products, solutions and services for our cell therapy customers, and expands GE's technology reach to a number of new cell and therapy types. Biosafe, headquartered in the Lake Geneva region in Switzerland, with a global presence, has a 20 year track-record in automated cell processing and is a recognized leader in the field with reliable applications in bioprocessing, regenerative medicine and stem cell banking. Its proprietary products offer significant advantages over conventional processing tools, with closed fluid pathways, built-in traceability and single-use consumables. The strong strategic fit and complementary business models of GE Healthcare's Life Sciences business and Biosafe combined with expanded capabilities in product development and commercial reach, will offer significant customer and ultimately patient benefits. Kieran Murphy, CEO Life Sciences, GE Healthcare said: "GE is building a world-class set of tools, technologies and services for cell and gene therapy and Biosafe's expertise and innovative systems will strongly enhance our customer offering. GE and Biosafe share a vision of an integrated approach to helping customers optimize every stage of their process to reduce production risks dramatically and increase access to these remarkable new medicines."   Claude Fell, Founder and Chairman, Biosafe Group SA, said: "Together with GE we will have the combination of biological, engineering and industrial capabilities to help accelerate the fields of cell therapy and cellular immunotherapy into the mainstream, benefitting patients globally, and bringing the vision of personalized medicine to reality." Olivier Waridel, Biosafe CEO, who will continue to lead Biosafe within the new integrated GEHC structure, added: "Joining GE Healthcare will give Biosafe an outstanding opportunity to couple its unique cell processing technology with GE Healthcare's strong, global infrastructure, leading to improved capabilities for our customers and enhanced market penetration."     ]]> https://biospectrumindia.com/news/97/8254/positive-bioscience-launched-positive-atgc.html https://biospectrumindia.com/news/97/8254/positive-bioscience-launched-positive-atgc.html Fri, 22 Jul 2016 10:23:33 +0530 Positive Bioscience launched Positive - Academy for Training in Genomics and Clinical application (ATGC), an initiative to help oncologists gain competency at using genomics in their practice. The initiative will be rolled out across the country in association with ICON and MOS (Molecular Oncology Society). Positive ATGC willconduct regular workshops in Delhi, Hyderabad, Bangalore, and Mumbai. Participants of the workshop will be awarded a certificate, which will be accepted as CME. The workshops will also be available online. PositiveATGC workshops have been designed to enhance the education of clinical oncology professionals on the topics of cancer genomics, cancer risk assessment, and application of precision medicine in clinical practice.The workshops will include topics on technology and equipment, understanding and applying genomic report to clinical practice,as well as concept of pathways and its utility in clinical practice. Positive ATGC will also conduct six-month training programs on genomics for doctors. The training will be certified by a leading Medical University.Positive Academy for ATGC aims to reach out to over 200+ doctors by 2017.The Academy will publish periodic newsletters for updating Oncologists with the latest developments in genomic technology. Dr Purvish M. Parikh, President of Molecular Oncology Society and Director of Precision Oncology at Asian Cancer Institute said,  " The only way to optimise cure and treatment in cancer is by selecting the right drug at the very first instance. This requires proper understanding of the tumor as well as normal metabolism of the patient. These key aspects are identified only by in-depth genetic testing. Hence they have become the norm today's age of personalized medicine and precision oncology. In fact, we are quickly moving away from classifying cancer tumors based on organ of origin (e.g. breast or lung cancer) and now relooking at them based on driver mutations (changes in genetics that are causing the cell to become cancerous). For instance tumors that are caused by mutations in the "alk" gene will be called alkomas." Samarth Jain, Founder & CEO, Positive Biosciences said,  "With the vast increase in knowledge stemming from genetics research and the development of new technologies in genomics, Genetics education and training of oncologists is critical for building capacities to understand, interpret, and appropriately apply such information. As the advancement of genetic technologies accelerates, so must the education and training efforts. This initiative is our contribution to enabling the integration of genomics into clinical practice, so that patients in India can benefit.       ]]> https://biospectrumindia.com/news/97/7748/medtronic-gets-fda-nod-for-cement-augmented-pedicle-screws.html https://biospectrumindia.com/news/97/7748/medtronic-gets-fda-nod-for-cement-augmented-pedicle-screws.html Thu, 21 Jul 2016 10:37:27 +0530 Medtronic plc has announced the US Food and Drug Administration (FDA) 510(k) clearance of the CD Horizon Fenestrated Screw Set, which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. This marks the first US clearance for cement-augmented pedicle screws. The CD Horizon Fenestrated Screws are used with Medtronic's HV-R Fenestrated Screw Cement, a polymethylmethacrylate (PMMA) cement, and are intended for use at spinal levels where the structural integrity of the spine is not severely compromised. Medtronic's CD Horizon Fenestrated Screw Set features cannulated pedicle screws designed with six holes (fenestrations) located near the end of the screw, allowing controlled cement injection into the targeted vertebral body after having placed all of the screws. This self-curing PMMA cement provides immediate screw fixation in the patient's spine and significantly increases the screw pull-out strength compared to standard screws. The cement is injected through a continuous tract in the adapter and into the screw cannula. This continuous tract delivery system is designed to have a completely secure channel that can be visually verified outside the patient to help reduce the likelihood of cement leakage at the adapter/screw interface while being compatible for minimally invasive surgery (MIS) and open procedures. "Palliative care is important for people with cancer, and Medtronic's cement-augmented screws are a meaningful innovation that are designed to restore the integrity of the spinal column in patients with debilitating spinal tumors," said Doug King, senior vice president and president of Medtronic's Spinal division, which is part of the Restorative Therapies Group at Medtronic. "The availability of our CD Horizon Fenestrated Screw Set represents an important advance for surgeons and provides them with another option for a complex procedure." The CD Horizon Fenestrated Screw Set will be available this fall.   ]]> https://biospectrumindia.com/news/97/6675/ims-health-partners-with-cloudera-enterprise.html https://biospectrumindia.com/news/97/6675/ims-health-partners-with-cloudera-enterprise.html Wed, 20 Jul 2016 12:58:00 +0530 IMS Health has partnered with Cloudera Enterprise to support its Big Data Factory, a cloud-based platform that transforms data into intelligence for life sciences and healthcare clients as they navigate dynamic markets, drive operational excellence and demonstrate the value of medicines. "As IMS Health continues to innovate with Big Data, Cloudera will advance our efforts to build and provision breakthrough data processing and data warehousing solutions," said Karl Guenault, chief information officer and vice president of Operations, IMS Health. "We're excited to apply Hadoop and other open source technologies for integrating, processing and interpreting more extensive and granular data - helping our customers drive healthcare performance." The combined solution will support: Next-generation data processing. Cloudera's latest open source technology platforms support machine learning - which uses cognitive systems to automate quality control, data bridging and modeling, and other repetitive tasks-to drive evidence-based decisions for clients. Using the Hadoop cluster technology, IMS Health can extract, store and analyze vast quantities of unstructured data for generating new, more comprehensive insights for customers. Accelerated time to insight. The IMS Health Big Data Factory will harness Hadoop's parallel processing technology to streamline data acquisition and management, delivering powerful insights with higher efficiency. Scalable data management. The Hadoop distributed file system (HDFS) eliminates data transfer bottlenecks, storage capacity delays and time spent adding new servers to augment traditional data clusters - enabling IMS Health to improve the speed and scalability of Big Data management. "The insight that IMS Health will gain through the platform can ultimately be measured in better patient outcomes, and Cloudera is thrilled to work with them on this endeavor," said Shawn Dolley, Cloudera Industry Leader for Health and Life Sciences. "As the leading provider of open source Hadoop solutions, Cloudera and IMS Health are uniquely positioned to support the growing needs of healthcare organizations looking to optimize their data utilization and provide better care." ]]> https://biospectrumindia.com/news/97/7744/agilent-launches-new-triple-quadrupole-gc-ms-instruments.html https://biospectrumindia.com/news/97/7744/agilent-launches-new-triple-quadrupole-gc-ms-instruments.html Wed, 20 Jul 2016 09:58:32 +0530 Agilent Technologies enhanced its line of scientific instruments with two new models of the company's 7000 Series Triple Quadrupole Gas Chromatography/Mass Spectrometry systems. Agilent is showcasing the new quadrupole GC/MS/MS instruments-along with a new analyzer for pesticides and environmental pollutants-at the North American Chemical Residue Workshop, a four-day gathering for scientists interested in developing better analytical methods, which starts today in St. Pete Beach, Florida. "Increasingly, laboratories that test the safety of our food and water are turning to triple quadrupole GC/MS systems because their selectivity makes them better able to handle complex matrices than standard single quadrupole systems," said Monty Benefiel, vice president and general manager of Agilent's Mass Spectrometry Division. "Both of our new instruments-the 7000D and 7010B-include enhancements that not only improve analytical performance but make them easier to use than any previous triple quad GC/MS system." Benefiel noted that Agilent's extensive single quad GC/MS installed customer base, who want to run samples on their triple quad, can open existing single quad GC/MS methods with a single mouse click using Agilent MassHunter software. "Nobody else makes it that easy to distribute your total workload among all of your available Agilent GC/MS systems, adding greater capacity to their laboratory," he said. "This capability also streamlines the transition from SIM on the single quad to MS/MS on the triple quad." The 7010B includes Agilent's exclusive high-efficiency ion source, which enhances the instrument's sensitivity by a factor of 10. Both models are also available with Agilent's patented JetClean self-cleaning ion source. Using a carefully controlled hydrogen flow, the JetClean source readily removes matrix deposits, which can build up over time and compromise instrument performance.   Agilent's fourth-generation Pesticides and Environmental Pollutants Analyzer based on the 7010B provides laboratories with a turnkey solution for detecting, identifying and quantifying pesticides in food and environmental matrices. It also takes advantage of new dMRM capability in MassHunter Acquisition and a new pesticide database that includes matrix optimized transitions to confidently detect contaminants in food and water samples.     ]]> https://biospectrumindia.com/news/97/1071/roche-india-appoints-new-md.html https://biospectrumindia.com/news/97/1071/roche-india-appoints-new-md.html Tue, 19 Jul 2016 14:46:45 +0530 Roche Diagnostics India, a company in the in-vitro diagnostics (IVD) industry, announced the appointment of Dr Shravan Subramanyam as the managing director, for its operations in India and the neighboring markets, comprising Bangladesh, Nepal, Sri Lanka and Bhutan. Mr Guido Sander, who was earlier the MD of Roche Diagnostics India, has shifted base to Singapore, to head high growth markets for Roche Diagnostics' APAC business. His portfolio, which includes India, now also covers Vietnam, Myanmar, Pakistan and Indonesia. Mr Sander said, "I am pleased to welcome Dr Shravan to Roche. His wide experience covering pharmaceuticals and diagnostics, in countries which are at different stages of healthcare evolution will be valuable for the growth plans of the Roche Diagnostics India and neighboring markets business....." A physician from Madras Medical College, Dr Shravan completed his Masters' degree in health administration at Cornell University, where he served on the alumni board.   He has a passion for diagnostics, and is particularly keen on exploring personalized healthcare, with the goal of providing the right treatment for the right group of patients. Dr Subramanyam commented, "I am excited to be a part of the brand Roche... I look forward to being a part of this journey...." ]]> https://biospectrumindia.com/news/97/8411/boston-scientific-announces-launch-of-integrated-facility-in-india.html https://biospectrumindia.com/news/97/8411/boston-scientific-announces-launch-of-integrated-facility-in-india.html Mon, 18 Jul 2016 11:52:41 +0530 Boston Scientific India officially opened a 100,000 sq. ft. research and development, training and commercial center that will enable it to develop and sell minimally invasive technologies fit for India and the greater Asian market, and train physicians in using them effectively. The new facility marks a strategic investment by Boston Scientific. The Research and Development (R&D) Center will focus on creating market-appropriate products based on unmet clinical needs in emerging markets, and will also serve as a global product engineering center. The state-of-the-art Institute for Advancing Science (IAS), a physician training facility equipped with world-class simulators for hands-on training on innovative technologies, is the newest addition to the growing global network of Boston Scientific IAS facilities. As a key country in the company's emerging market strategy, India's improving economic conditions and healthcare access show potential for the growth of the local healthcare industry and need for medical devices. By establishing a consolidated presence in the region, Boston Scientific will extend its reach in India, offering solutions to physicians and patients combatting conditions in areas such as cardiovascular disease, cardiac arrhythmias, gastrointestinal and urologic disorders, and chronic pain. The launch was attended Shri. Faggan Singh Kulaste, Minister of State for Health and Family Welfare, Capt. Abhimanyu Honorable Finance Minister, Government of Haryana, and Mr. John M. McCaslin, Minister Counselor for Commercial Affairs, United States Embassy, New Delhi. Also present at the launch were several of the country's top physicians, representatives from the health sector, partner organizations, academia and members of industry associations such as The National Association of Software and Services Companies, U.S. India Business Council, American Chamber of Commerce, the Federation of Indian Chambers of Commerce and Industry, NATHEALTH, MTaI and the Confederation of Indian Industry. Health Minister Shri. Kulaste said, "The need for innovation in medical technology is a high priority in many countries worldwide, and the government will support all efforts in research and innovation so that affordable and quality care is accessible to more and more patients in India."   "India is an important market and it holds great potential for the global medical devices industry," said Prabal Chakraborty, Vice President and Managing Director for Boston Scientific in India. "The Indian ecosystem has all the right ingredients for innovation, namely a best-in-class technical talent pool in the areas of STEM (Science, Technology, Engineering and Math), world-renowned physicians who bring an understanding of clinical unmet needs, and top-notch academic institutions. We plan to tap into the high caliber talent pool and the innovation ecosystem to deliver cutting-edge medical device innovation. The launch of this facility underscores our commitment to India, and we are confident that our R&D activities will address many of the current health challenges of the country and the world." At the opening ceremony, Health Minister Shri. Kulaste flagged off the Boston Scientific Navigation Express, an innovation mobile van that will travel through 11 states, 53 cities, and 206 hospitals in six months to educate physicians, hospital administrators, and medical technicians on the new range of medical devices available today to enhance diagnosis and treatment efficacy in order to improve patient outcomes.   ]]> https://biospectrumindia.com/features/97/7619/have-the-revised-guidelines-improved-the-clinical-research-environment-in-india.html https://biospectrumindia.com/features/97/7619/have-the-revised-guidelines-improved-the-clinical-research-environment-in-india.html Fri, 15 Jul 2016 15:08:00 +0530 The Indian Clinical Research Industry went through a trying phase in 2013 and 2014. However, 2015 saw steps taken by the Indian regulators to mitigate the challenges posed by regulatory uncertainty and address stakeholder concerns through amendments in regulations, new orders and further guidance on existing ones. Have these new guidelines improved the clinical research scenario? How does the future look for Indian clinical research industry? Read on to find out... Have the revised guidelines improved the environment?The most significant of these changes were revisions to the compensation guidelines and audio visual recording during clinical trials which were major barriers for sponsors conducting clinical trials in India. "The compensation guidelines are now more balanced and rational; we are beginning to see more predictable approval timelines with the expansion of the Subject Expert Committees and the expected roll-out of the accreditation process is projected to have a significant impact on the quality of research," Dr Rajashree Devarakonda, Vice President, India and Asia Pacific, Voisin Consulting Life Sciences (VCLS). She added, "This is a major improvement from the previous guideline and now this brings India back to almost the same level playground as other global counter parts. In addition, CDSCO has launched a new online clinical trial submission system as part of efforts to increase accountability, transparency and efficiency in processing clinical trial applications." However, it will take time to see the real impact of these changes although there is already begun a reduction in approval timelines. "The environment is certainly more positive but rebuilding trust and confidence is a long and slow process. What has been extremely encouraging is the inclusive approach adopted by the Indian regulators whereby stakeholder feedback has been actively sought and acted upon in many cases. We now have a regulatory system that is balanced, aligned with global trends and one that addresses our uniqueness as a country and society. This is a significant development," Ms Suneela Thatte, President, ISCR (Indian Society for Clinical Research).   India: Numero Uno, Again?While Indian Clinical research industry was going through a turbulent phase, South Korea (and many other Asian countries) has emerged as the preferred destination for clinical trials. Would India be Numero uno again? "I would, at the outset, like to clarify that India was never a country that had a very high percentage of trials relative to trials being done in the rest of the world nor is it our objective to be the number one country in the region or globally for doing trials. What is important is that the trials being done in India are significant enough to address our growing burden disease and the unique healthcare requirements of our country." points Ms Thatte. She further added that the Government of India sponsored Working Group on Disease Burden for the 12th Five Year Plan refers to the "triple burden of disease" that developing countries like ours are facing arising from Communicable Diseases (like TB, Leprosy, vector borne diseases, water-borne diseases, zoonotic diseases and vaccine preventable diseases), Emerging Non-Communicable Diseases related to Lifestyles (like cancer, cardiovascular diseases) and Emerging Infectious Diseases (like Ebola virus, SARS, H1N1). Therefore clinical research in our country is a health imperative and important to the progress of the health of our people and the economy. "Positive changes around regulatory framework and policies are happening. Changes to compensation issue and audiovisual recording, improved review time of clinical trial application, improved monitoring etc. has slowly started attracting sponsors back from other countries back to India," said Dr Devarakonda. Attraction of India in terms of its large patient pool, low cost of doing business, availability of expert researchers, and, huge market opportunities still remains. It is very much a possibility for India to regain its position as compared to other Asian countries.   "However, regulatory approvals and extended timelines in clinical trials need a coherent set of stand-alone rules and safe drugs adhering to Good Clinical Practices, the compulsion of conducting clinical trials to improve therapeutics should be effectively communicated to the public, patients, media and policy makers, new regulatory personnel to be recruited and trained on an ongoing basis to meet the growing requirements of clinical trial applications. In summary, capabilities building for development of new drug that can help the country tackle public health challenges," said Dr Devarakonda. Enabling more trials in IndiaIndia has the highest burden of disease in the world, the second largest patient population and yet less than 1.4% of global clinical trials are done in India. What do we need to do to address our triple burden of disease and ensure better, cheaper and more accessible medicines for our population? "We need a robust, regulatory framework that ensures that clinical research is conducted in a fair and transparent manner, safeguarding the interests of patients while keeping in line with the basic tenets of science. India needs to take a more proactive role in conducting Clinical Research for India. A more conducive regulatory framework for the conduct of clinical research in the country will enable this and encourage local innovation, ensuring that Make in India is a reality for the drug development and clinical research sector in India" stated Ms Thatte. "However, India should undertake operational research on diseases and should establish good surveillance systems and develop validated data banks which in turn will enable more number of clinical trials/research. The data gaps need to be addressed with high priority given to operational research and adequate resources being allocated," said Dr Devarakonda. She continued, "The necessity of conducting clinical trials for better therapeutics should be effectively communicated to the public, patients, media, policy makers, more and more participation in clinical trials so that number of these medications could be made available to Indian population not only during clinical trials but also in some cases post trial before even products gets commercialized when proven beneficial with reduced risks."   Future outlookThe future for clinical research in India certainly looks more encouraging today than it did 2-3 years ago. One of our greatest challenges is to instill confidence and trust amongst global stakeholders about the evolving and more scientific regulatory environment in India and the fact that there is now a more conducive environment for clinical research in the country. "Few global companies have already started testing the water as definitely India offers a substantial cost advantage relative to developed and emerging economies, the urban healthcare infrastructure in terms of beds/ physicians/ nurses will be comparable with the global average. India offers an abundant and growing pool of skilled, talented and experienced medical professionals, several government-funded pharmaceutical and medical institutions with state-of-the-art facilities, which can serve as ideal centers for multi-centered clinical trials," said Dr Devarakonda. It is the collective responsibility of all stakeholders across the clinical research to restore confidence in a clinical research process that stands not only for quality and innovation, but also safety and ethics, while also highlighting the need for clinical research in the country. "We hope that we will eventually reach a state where we are recognized for the high quality of clinical research done in the country, there is more acceptance and realization across the public at large about the role and relevance of clinical research in India and that it contributes to the greater good of everyone, patients are acknowledged for their selfless contribution to bringing new drugs and new treatment to market and we will, in particular, discover new drugs and treatment to treat illnesses that are endemic in our country," said Ms Thatte. It is the hope of Indian Clinical trial fraternity that new and reformed regulations once amended further will be able to bring back Indian clinical research industry to the highest global ethical standards very soon.   some of the positive developments: Revamping of Regulatory Review and Approval ProcessGovernance over Clinical Research Conduct at SitesMonitoring of Clinical trialsMonitoring of Ethics committees, ethics committees registration, establishment of Subject matter experts committees for review of clinical trial applicationScientific discussion with sponsors before Clinical Trial application so that critical aspects of the study could be discussed and concerns addressedLimiting the number of trials performed by Principle investigators at the same time Limiting recruitment of too many patients at one site within a set period of time, Improved review of clinical trial applications by reducing the timeline to almost 6-7 monthsCompensation to only events related to clinical trial drug and audiovisual recording for selected clinical trials   ]]> https://biospectrumindia.com/features/97/7437/trauma-fixation-market-set-for-marginal-growth-.html https://biospectrumindia.com/features/97/7437/trauma-fixation-market-set-for-marginal-growth-.html Wed, 13 Jul 2016 16:29:21 +0530 The global trauma fixation market, which includes internal and external fixation devices to treat and manage bone fractures and covers 39 markets, is set to experience a minor increase from approximately $6.4 billion in 2015 to $7.4 billion by 2022, at a Compound Annual Growth Rate (CAGR) of 2.2%, according to research and consulting firm GlobalData. The company's latest report states that global reimbursement and regulatory limitations, as well as the preference for locally manufactured implants in emerging markets, are demanding obstacles which are curbing potential growth. Ms Jennifer Ryan, GlobalData's Analyst covering Medical Devices, explains: "Medical device regulation has slowly developed into a more rigorous and taxing process, especially for companies attempting the premarket approval path, which requires heavy development and financial commitment to prove the efficacy and safety of a new product." Proving the efficacy of orthopedic devices has also been a challenge facing companies trying to bring new products to market. The US 510(k) regulatory process requires that manufacturers demonstrate a device is substantially equivalent to a predicate device before approval is given by the Food and Drug Administration (FDA).   For orthopedic devices, this is a lengthy process, as it can take years before device success or failure is evident. The trauma fixation segment, where much of the innovation revolves around materials research and biodegradation, faces particular difficulty. Ms Ryan continues: "Developed nations have seen decreasing orthopedic reimbursement rates in recent years, driven by a desire to maintain low healthcare costs in the face of the rising number of fraction fixation procedures. In turn, this has forced manufacturers to lower implant prices in order to stay competitive. "Emerging markets are also suffering from the effects of poor reimbursement as inadequate insurance coverage and the high costs of surgery are keeping patients from using fixation devices. Improved reimbursement and healthcare access in these countries will permit market growth as patients are able to adopt more robust treatment methods." Although these barriers serve to slow market growth, the global demand for trauma fixation devices remains due to the growing elderly population, the rising number of motor vehicle accidents as emerging markets urbanize, and increasing prevalence of fracture risk factors such as obesity and osteoporosis.   ]]> https://biospectrumindia.com/features/97/7268/technology-advancements-digital-pathology.html https://biospectrumindia.com/features/97/7268/technology-advancements-digital-pathology.html Wed, 13 Jul 2016 12:42:56 +0530 Healthcare is perhaps the only sector which remains impervious to technology advancements, though things are changing at a pretty fast speed.Digital pathology involves the scanning of whole histopathology or cytopathology glass slides into digital images interpretable on a computer screen, along with data management, translates to additional functionalities such as web accessibility, annotations, automated image analysis, and a host of breakthrough applications in the practice of pathology, and health care systems as a whole. Digital Pathology vs conventional pathologyTraditional pathology workflows have innate delays built into the processes. Transferring unique glass slides runs the risk of loss, and when collaborating with others requires time, which delays diagnostics. "Digitizing images that are normally viewed through a microscope can help improve the operational efficiency of a lab. Direct access to files can make diagnosis - in particular consults - simpler, more efficient and safer. It lowers barriers for internal and external consults, and can be done more quickly since colleagues can view the same case at the same time. This all can help increase the quality and speed of the lab. Furthermore, a digital workflow is the prerequisite and first important step to unlock the huge potential of future digital analysis in pathology," said Mr Hans Driessen, Marketing & Communications Manager, Philips Digital Pathology Solutions. Virtual slides can be transmitted from remote locations for review by pathologists and for second opinions. This is even more beneficial in cancer diagnosis. The conventional method involves transportation of the slides to avail the opinion of the experts and this has a direct impact on the time taken for diagnosis. "Digital pathology has made it easy to obtain second opinions from the experts, across geographies, without transporting slides. This facilitates faster reporting. The only prerequisites are the scanned digital images and a good internet speed! This innovation brings several advantages to all the different stakeholders associated with an anatomic pathology lab. Pathologists can provide faster consultation and diagnosis, while clinicians see a faster turnaround time for referrals. The histotechnologists benefit due to the improvement in efficiency on account of reduced glass slide movement," said Dr Sandeep Sewlikar, Head - Medical & Scientific Affairs, Roche Diagnostics India.   Digital pathology also plays a key role in education, by providing an interactive learning environment. Virtual slides are single (although complex) giant images, they can be placed on a server with a URL and thus can be used in Web-based education. "Imagine changing the teaching methods from the conventional methods of reading each slide under a microscope, one student at a time, Vs the use of a digital image with zoom, pan, annotate, crop feature in a classroom on a projector wall. The same concept can be easily extended to tele-pathology, and hence increase the reach of a pathology lab and closer to areas which lack full fledged Pathology labs and qualified Pathologists," said Mr Prasanth Perugupalli co-founder and CEO at Spectral Insights. Adoption in the developing vs developed worldThe adoption of this technology is at a rather slow pace. The reason for the delayed adoption is primarily linked to the need for investment, as the high-end, whole slide imaging (WSI) scanners are expensive. Since the image sizes are also huge (ranging from a few MB to several GB) the image storage servers also contribute to further increasing the overall investment cost. "Western world had adopted digital pathology for several years now, driven initially by insurance mandates as well as lack of skilled manpower. As the advantages of digital pathology started to become more and more evident, there has been a tremendous push towards digitization becoming a de-facto standard," said Dr Sewlikar. He added, "However, there are still no standards for digital pathology in lines of digital radiology. Also, the systems made to address the primary drivers as stated above have been very expensive due to heavy reliance on robotics and automation." The new generation WSI scanners are fast and specifically intended to facilitate complete digitization within the lab. This has encouraged faster adoption. The advent of high computer processing power, improved storage capability at reduced costs, high data transfer speed due to improvement in internet services are all facilitators to early adoption. In the developing world, the problems and challenges are different. "The emphasis is on lowering the test costs while providing accurate analysis. The systems built for western world have not been successful in finding markets in the developing world because of high pricing as well as stringent environmental requirements for cleanliness, conditioned labs, etc. Also, the servicing of such equipment is a concern," stated Mr Perugupalli. Due to these constraints, and also the historical lack of mid-high tier computing and networking capabilities at Pathology labs and hospitals, Digital Pathology has remained at a nascent state for several years now. "The opportunity is for the developing world to take a big stride in healthcare by embracing digital pathology to bridge the gaps in coverage and quality between the few central labs in large cities and the rest of the labs elsewhere across the country," said Mr Perugupalli. Digitization involves a mindset change, that demands moving from microscopes to monitors for diagnosis and this is also one of the reasons for delayed adoption. "Studies have shown that the attitude of the pathologist towards the digital workflow is important. For more than a hundred years pathologists have been working with the conventional microscope, so the most difficult part is to learn to trust the digital image," said Mr Driessen. He continued, "The digital transition of the pathology workflow is much more than a technical experience, and change management is key to be successful. Education and user-training, together with the digital pathology vendor, can help. Though the old way was good, the new way knows no boundaries. While working with the digital workflow, it will show pathologist what this innovation means to their profession." Digital Pathology makes tele-pathology a reality, and fills holes in the basic infrastructure prevalent in the developing world. It raises quality of services, while raising productivity of the specialists. These factors, coupled with innovative business models are expected to make digital pathology wide-spread in the developing world. However, to achieve this goal, systems need to be designed keeping the local conditions in mind, and a one-size-fits-all solution has less likelihood to be successful. Limitations of WSIThe biggest limitation to widespread adoption of WSI has been cost. High end microscope with automated scanning stage is needed, and also large amount of storage and image processing software is required to perform WSI. "WSI can be used to review histologic sections, cytology slides, and/or hematology slides to render diagnosis. Validation of WSI is crucial to ensure that diagnostic performance based on digitized slides is at least equivalent to that of glass slides and light microscopy. Currently, there are limited standard guidelines regarding validation of WSI for diagnostic use," said Dr Sewlikar. Mr Driessen added, "Until now, there has been little public guidance provided to the industry with respect to the regulatory route in the United States. Through close collaboration among all the benefactor members of the Digital Pathology Association (DPA) including Leica Biosystems, Omnyx, Philips and Roche, the industry was able to work with the FDA to gain valuable clarity and guidance."New systems are being proposed around the world to bring digital pathology and WSI to neighborhood labs, while making compromises on some aspects that are specific to demographics.  Digital Pathology for Personalized MedicineThe use of digital pathology has the potential to enhance the pathologist's contribution in the successful development of personalized targeted therapy. One of the components of personalized medicine for cancer patients includes the standardization of biomarkers for identification of a molecular target, and the application of an effective therapy against it. "In Digital Pathology, there are inbuilt quantitative companion diagnostic algorithms that help in selection of patients for targeted therapy. For clinical laboratory applications, the confidence levels for reporting is further enhanced if these algorithms are backed by regulatory approvals like the FDA," said Dr Sewlikar. Personalized treatment options demand a more confident diagnosis. Collaborative involvement to obtain and integrate relevant information from different disciplines is necessary to achieve this goal. "Developing an effective treatment plan requires access to related patient information from multiple sources (EMR, LIS, PACS). The development of specific algorithms for automated interpretation of advanced stains will facilitate the objective analysis of images. By developing advanced algorithms and data management systems, we can help researchers translate the 'Big Data' promise into knowledge," said Mr Driessen. With digital images, the ability to run many Software tests as you can on the same images provides the potential to flag any abnormalities that weren't prescribed for testing at the current time. This has the potential to discover and alert conditions that may be at nascent stages and yet to cause a noticeable physiological change to the patient. "Based on digital images obtained from a number of specimens, new predictive insights can be drawn that have a bearing on demographics, socio-economic and environmental conditions, leading to actionable outcomes from personal as well as public health level," said Mr Perugupalli. Although Digital Pathology was primarily intended for second opinions and consultations, the biggest benefit it provides is in terms of improved workflow management in the anatomic Pathology lab. While embarking on a journey of digitization, it is important to identify an industry partner who can provide the requisite high speed scanners and also support entire journey from IT integration to efficient image & workflow management. Ultimately this digital pathology workflow will help to increase service levels to physicians, reduce cost and improve care. Some of the products available in the market:Philips IntelliSite Pathology SolutionAperio Digital Pathology Slide Scanners by Leica BiosystemsOmnyx IDP Solution by GE healthcareRoche Digital Pathology Solutions ]]> https://biospectrumindia.com/interviews/97/8403/india-is-recognized-as-one-of-the-global-manufacturing-destinations.html https://biospectrumindia.com/interviews/97/8403/india-is-recognized-as-one-of-the-global-manufacturing-destinations.html Wed, 13 Jul 2016 12:42:39 +0530 Datwyler Sealing Solutions develops, designs and manufactures solutions for injectable packaging and drug delivery systems. This 100 year old organization has a global manufacturing footprint on three continents, and sales in over 100 countries.Datwyler Sealing Solutions has been present in India since 2010 and the firm is rapidly expanding its footprint in India.In an interview with us Mr. Rahul Dev, Vice President, Datwyler India tells us more about its operations in India. Edited excerpts: 1. Please introduce Datwyler Healthcare. What is the focus of your work and what are some of your core priorities?The Datwyler Group is listed in the Swiss Stock Exchange and has celebrated its 100-year-anniversary at the end of 2015. Within the health care division, Datwyler develops, designs and manufactures high-quality solutions for injectable packaging and drug delivery systems which enables customers to create a safer medical environment. We are a leading partner to global pharmaceutical companies and the global number two for closure solutions for injectable medicines, as we produce 15 billion components for health care products each year.In the Indian market, we are presently focusing on high-end rubber formulations for products like plunger stoppers, Lyo, serum stoppers and customized rubber stoppers. Our latest investment in India through the commencement of the FirstLine facility in Satara (Maharashtra) underlines this focus. 2. Could you please provide us with an overview of the structure of the Datwyler operations?The Datwyler Group is a focused industrial supplier with leading positions in global and regional market segments. With its technological leadership and customised solutions, the Group delivers added value to customers in the markets served. Datwyler concentrates on markets that offer opportunities to create more value and sustain profitable growth. The Sealing Solutions division is a leading supplier of custom sealing solutions to global market segments, such as the health care, automotive, civil engineering and consumer goods industries. We have a global manufacturing footprint on three continents and sell our products in over 100 countries. Globally, the division has a workforce of more than 5,500 employees. 3. What was the rationale behind setting up an office in India? India's pharmaceutical and biotech markets are evolving rapidly and within the last years, they were able to gain traction from global manufacturers, suppliers and customers. The country is also being recognized as one of the global manufacturing destinations. Our new facility in Satara makes a great business case for us as we look at catering to global markets. Datwyler Sealing Solutions is one of the leading producers of closure solutions for injectable and vial medicines. The company's products are supplied to the world's leading pharmaceutical and biotechnology companies to support their efforts towards safe and effective drug delivery for a healthier world. 4. Please tell us about Datwyler Healthcare's operations in India. Datwyler Sealing Solutions has been present in India since 2010. With our operations, we are dedicated to guaranteeing the highest levels of quality and safety, and continue to make investments aimed at meeting global regulatory requirements. Recently, we have announced the construction of our most advanced manufacturing facility: FirstLine. The new facility at the Datwyler India site in Satara, Maharashtra is part of the company's commitment to India and the Asian markets. Spread over an area of 24,000 m², the facility will be integrated in the existing premise and will start to operate in 2017. The plant has been delivering commercial supplies to customers worldwide since 2013. The site also offers additional 24,000 m² for future growth. The most complex rubber components produced at the FirstLine site belong to the Omniflex family of vial and syringe components. They prevent any interaction with the drugs due to their total fluoropolymer coating. These components are exclusively manufactured at the Datwyler FirstLine sites.   5. What products make up the largest faction of the company output?In the health care segment, the largest faction of the company´s output is generated by the following three products: Stoppers for blood collection devices, stoppers for vials and plungers for prefill syringes. 6. The packaging industry is in continuous evolution and to remain competitive you have to constantly create technological innovation. How do you achieve such competitiveness given this industry characteristic?Datwyler has invested a significant amount of money into R&D in the past and will continue to do so in the future. We also place great importance on direct contact to our customers in order to understand their requirements and develop our products in line with their needs. Our dedicated teams provide our customers with expert knowledge in materials, surface treatments, and simulation for innovative sealing solutions. Furthermore, Datwyler always aims for new innovations and a future-oriented working approach. 8. What is your international expansion strategy?Presently Datwyler is expanding in India. The company has also purchased ten additional acres adjacent to the plant for future growth. 9. How has Datwyler evolved from its founding in 1915 to its current role? Major changes have taken place in the industry in general, and particularly in the packaging component industry that we are operating in. First, there is an increasing globalization of the industry. Our customers are becoming more global and are expecting us as their supplier to cater to their ever changing needs, large or little. Datwyler has long understood this concept, which is why, for instance, the company diversified into rubber for pharmaceutical application approximately 50 years ago. As a result of these developments, Datwyler has become a global player itself. Considerable and constant investments are made to improve our global manufacturing footprint and keep the company's leading position in the market.   ]]> https://biospectrumindia.com/features/97/7204/global-biosurgery-market-to-reach-7-6-bn-by-2022.html https://biospectrumindia.com/features/97/7204/global-biosurgery-market-to-reach-7-6-bn-by-2022.html Tue, 12 Jul 2016 16:31:52 +0530 The global biosurgery market, which covers hemostats, tissue sealants, tissue adhesives, and surgical adhesion barriers, is set to rise from $6 billion in 2015 to $7.6 billion by 2022, representing a steady compound annual growth rate of 3.6%, according to research and consulting firm GlobalData. The company's latest report states that drivers of this growth, which will occur across 15 major markets, include aging populations in many countries, rising disease rates that necessitate a greater number of surgical interventions, and improving healthcare infrastructures in emerging countries that allow for more advanced therapies to be adopted. Mr Shashank Settipalli, GlobalData's Analyst covering Medical Devices, explains: "Emerging markets, particularly large ones such as India and China, have significant untapped potential in expanding the worldwide surgical devices market. As incomes and living standards in these nations continue to rise, a greater segment of the world's population demands better healthcare. "This trend entails greater volumes of procedures being performed in nearly every specialty because more people can afford surgeries that were previously prohibitively expensive, increasing the need for surgical tools and accessories." Another driver is the need to curtail the impact of excessive blood loss, which is second only to head injury as the leading cause of death in trauma cases.   In this way, devices such as hemostats, surgical sealant, and tissue adhesives can play an indispensable role in the operative phase of trauma management, and will become more widely used as need increases. Mr Settipalli continues: "As well as increased use of this kind of equipment, higher-cost materials will also see greater uptake. Fibrin biosurgery products, for example, have become adept hemostats, internal surgical sealants, and external tissue adhesives, and their uptake will drive the overall biosurgery market. "Clinicians have known about fibrin's capability as an effective hemostat and sealant for over a century, but major regulatory authorities, such as the FDA, have approved market entry relatively recently. As the number of clinical trials demonstrating fibrin's effectiveness in a wider variety of fields expands, regulatory approval increases for greater indication coverage and companies gain access to a larger base of customers."   ]]> https://biospectrumindia.com/interviews/97/7143/there-is-an-increasing-demand-for-biopharmaceuticals-worldwide.html https://biospectrumindia.com/interviews/97/7143/there-is-an-increasing-demand-for-biopharmaceuticals-worldwide.html Tue, 12 Jul 2016 12:51:26 +0530 In May this year, JHL Biotech (JHL), opened the world's first KUBio biopharmaceutical manufacturing facility in Wuhan, China. GE Healthcare's KUBio is a fully functional off-the-shelf bioprocessing facility specifically designed to meet cGMP requirements while optimizing manufacturing flexibility and productivity. The facility is pre-fabricated and delivered with a complete ready-to-use production line, based on GE Healthcare's Ready-to-Process single-use technologies.In an email interaction with us, Mr Jan Mäkelä, General Manager for the BioProcess business at GE Healthcare's Life Sciences business, tells us more about this innovative facility. Edited Excerpts: 1. Please throw some light on KUBio manufacturing solution. What is KUBioTM's core technology and what are its benefits?Mr Jan Mäkelä: GE Healthcare's KUBio is a prefabricated modular facility based on single-use technologies for monoclonal antibody production. The facility is installed with the FlexFactory platform, which comprises of bioprocessing equipment from the early stages of cell expansion all the way through to the downstream chromatography steps. This includes technologies such as mixers, bioreactors, filtration and chromatography systems which are integrated through a single automation platform (such as WonderWare or DeltaV).Using standardized equipment and an optimized layout also provides the bio manufacturer with a facility that can be replicated at multiple sites, for easy tech-transfer and scale-up.KUBio's key benefit is rapid construction, and corresponding reduction in risk. In comparison to the 2-3 years of design and construction which is typical for conventional stick-built bio manufacturing facilities, KUBio is ready-to-run in 14 to 18 months, translating to a faster time to market. This timeline includes every phase of the build including design, construction and full fit-out with bioprocessing equipment. Every stage of the project is supported by GE technical expertise, including facility design, procuring and production of process equipment, installation, qualification, staff training, technical support and project management. Financial guidance is also part of the offering. 2. What are some of the most pervasive operating challenges afflicting biopharma manufacturing today? How does KUBioTM's technologies fill the needs of the current bioprocessing manufacturing?Mr Jan Mäkelä: There is an increasing demand for biopharmaceuticals worldwide. Seven of the top 10 selling medicines by revenue are in a new class of drug called biologics, sales of which, over the past six years, have grown at 10% per annum to $170 billion, primarily because of the expansion of new treatments for cancer and demand for insulin. Biopharmaceutical manufacturers are looking for ways to expand their capacity and enter markets that have previously been difficult to access due to location. KUBio was launched to address these needs. The speed and flexibility of single-use components is now well-recognized across the industry - and GE Healthcare's know-how in the sector and global footprint makes us ideally-placed to harness this potential and package it for rapid deployment wherever a customer requires.3.Can you share with us list of your clients that have utilized KUBioTM's? How has been the reception/feedback by these companies?Mr Jan Mäkelä: This is the world's first KUBio, so JHL Biotech are the only owners of one these facilities at present. GE is now building another KUBio (purchaser has not yet been publicly announced) and is discussing project opportunities in such countries as Brazil, Mexico, South Korea and Saudi Arabia, among other places. 4. What are the major markets for KUBioTM's in Asia and what is the demand in these countries? Mr Jan Mäkelä: Currently in China, there is a huge unmet need for affordable biologics. China accounts for 20 percent of worldwide cancer incidence, the second-highest rate in the world. In 2015, around 4.3 million new cancer cases were reported in the country. Biologics hold significant promise in their ability to treat cancer, and are especially strong for targeted therapy in specific areas. Today, biologics account only for 4 percent of the medicines prescribed in China (vs. 22 percent in the US). In a drive to encourage biological medicine and medical device innovation in the region, a number of action plans have been issued by the region, pledging significant funding on the development of new therapeutics and placing a focus on biosimilars. For example China's State Council's 10-year action plan "Made in China 2025" recognizes biological medicines and medical devices as one of its key industrial focus areas. The market is growing rapidly in China and, reaching approximately $350 million in 2019, up from $44 million in 2009.KUBio offers global biopharmaceutical manufacturers the ability to reproduce world-class quality, standardized facilities, anywhere in the world. There is interest coming from both the developed and developing world. 5. What are the current trends in biopharmaceutical manufacturing industry and how is GE Healthcare positioned to address the changes? Mr Jan Mäkelä: The industry movement towards developing and producing more targeted (personalized) treatments for specific patient groups, has led to a need for more flexible facilities to allow manufacturers to quickly switch from manufacturing one product to another one. FlexFactory uses predominantly disposable, single-use technologies, eliminating cleaning validation steps reducing the risk of cross-contamination, and providing significant time and cost savings.   6.How is Asia positioned as a hub for biologics manufacturing? Which countries do you think have potential for biologics manufacturing and why? Mr Jan Mäkelä: Due to a large and aging population, coupled with the rising cancer rates and low penetration of biologic medicines, there is a huge demand for biologics in China. A highly skilled workforce as well as the introduction of a number of government funding initiatives to drive biopharmaceutical development provide significant opportunity in the region. 7.Are Asian markets going to influence biopharmaceutical development around the world? How strong is the biopharmaceutical industry in Asia?Mr Jan Mäkelä: The Chinese government has invested heavily in specific initiatives to drive the development of new therapeutics. MNDIP (Major New Drug Innovation Program) was the first initiative to change China from a manufacturing center for drugs to a center of innovation for new drugs. Started in 2009, this initiative has attracted $4.5 billion from 2009 - 2012. JHL Biotech, owner of the first KUBio, announced earlier this year that it has received authorization from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to begin clinical trial for JHL1101, a rituximab biosimilar to treat rheumatoid arthritis. JHL is the first company from the Greater China region to receive European approval for clinical trial of a monoclonal antibody biosimilar. Whether this is the beginning of a larger trend is too early to say. ]]> https://biospectrumindia.com/features/97/3398/inferior-vena-cava-filters-market-growth-limited-by-safety-concerns.html https://biospectrumindia.com/features/97/3398/inferior-vena-cava-filters-market-growth-limited-by-safety-concerns.html Mon, 11 Jul 2016 15:41:48 +0530 The global market for inferior vena cava filters, including permanent and retrievable filters, is set to grow from $279.1 million in 2015 to $294.9 million by 2022, representing a low compound annual growth rate of 0.8%, as concerns over device safety limit market expansion, according to research and consulting firm GlobalData. The company's latest report states that such minimal growth, which will occur across 15 major countries, will come as a result of recent clinical data highlighting complications associated with both permanent and retrievable filters. Mr Premdharan Meyyan, GlobalData's Analyst covering Medical Devices, says these trial results have impacted the market considerably, resulting in ongoing litigation and concerns over the current generation of devices. Major complications include vena cava penetration, filter embolization, filter migration, filter fracture, and filter tilt. Mr Meyyan explains: "There is a need to critically assess the impact that this emerging clinical evidence will have on this market in the future. Retrievable filters are now widely preferred over permanent filters, though filter retrieval rates in clinical practice are surprisingly low due to patients being lost to follow-up. "In order to combat the concerns associated with the use of inferior vena cava filters, companies are sponsoring initiatives that remind patients to get their filters removed in the proper time window in order to improve retrieval rates. Moreover, emerging players will need to design devices incorporating features that significantly reduce filter complication rates.   GlobalData states that the key players in the inferior vena cava filters market include ALN, Argon Medical Devices, B. Braun, Boston Scientific, C.R. Bard, Cook Medical, Cordis, and Volcano. Mr Meyyan continues: "C R Bard and Cook Medical are the dominant players in the current market landscape, though both brands are significantly affected by the ongoing litigation in the US, coupled with device safety risks that have come to light. "Emerging players that are expected to grow in market share include Argon Medical Devices and Volcano, which have entered the market more recently with updated device designs. For example, Volcano's Crux incorporates an expanded polytetrafluoroethylene (ePTFE) web to capture thrombi, which serves as a key point of difference from existing devices." ]]> https://biospectrumindia.com/news/97/6471/sartorius-stedim-biooutsource-introduces-new-released-n-glycan-assay.html https://biospectrumindia.com/news/97/6471/sartorius-stedim-biooutsource-introduces-new-released-n-glycan-assay.html Fri, 08 Jul 2016 11:38:06 +0530 Sartorius Stedim Biotech (SSB) announced the launched of a new Released N-Glycan Assay for the in-depth profiling of IgG glycosylation. This new physico-chemical assay, developed by SSB's subsidiary BioOutsource and offered in combination with its unique Antibody Dependent Cell Cytotoxicity (ADCC) assay platform, combines data on the molecular structure with a key therapeutic mechanism of action. This will generate comprehensive, highly accurate biosimilar comparability data, driving shorter drug development timelines. The new N-Glycan Assay is one of a range of orthogonal methods, including analysis by CD16a (FcγRIIIa) and SPR binding, as well as ADCC functional assays that BioOutsource offers to provide a detailed testing package to generate evidence suitable for regulatory submissions. BioOutsource's new assay involves enzymatically-removing glycans from the antibody, functionally derivatizing them and separating the glycans by UHPLC. The glycans are then identified by on-line electrospray ionization mass spectrometry (ESI-MS), enabling confident assignment and precise quantification of the different structures. Dr Daniel Galbraith, Chief Scientific Officer at Sartorius Stedim BioOutsource, explained, "The structural classification and monosaccharide composition of carbohydrates attached to the constant region of therapeutic biosimilar antibodies is key to their binding. An accurate understanding of these glycans ensures effective selection of biosimilars that have the optimum ADCC activity to destroy tumor cells." Dr Galbraith continued, "Our new Released N-Glycan Assay coupled with our ADCC assays will help deliver this understanding by providing robust biosimilar characterization data suitable for the regulators, thus enabling efficient drug development and more rapid entry into clinical programs."   ]]> https://biospectrumindia.com/news/97/8076/icon-to-acquire-clinical-research-management.html https://biospectrumindia.com/news/97/8076/icon-to-acquire-clinical-research-management.html Mon, 04 Jul 2016 12:29:22 +0530 ICON has announced that it has agreed, subject to certain customary closing conditions (including applicable regulatory approvals), to acquire Clinical Research Management, Inc. (ClinicalRM). The acquisition will enhance ICON's ability to access the market for government sponsored research and further enhances ICON's capabilities in the areas of Vaccines and Infectious Disease. ClinicalRM provide full service and functional research solutions to a broad range of US government agencies. Their extensive expertise extends across basic and applied research, infectious diseases, vaccines development and testing and the response to bio-threats. They have worked in collaboration with government and commercial customers to respond to the threat of global viral epidemics. Commenting on the acquisition, ICON's Chief Executive Officer, Ciaran Murray said, "The market for government sponsored research is significant with over fifteen hundred active clinical studies being funded by the National Institutes of Health or other federal agencies. ClinicalRM has strong relationships and a deep understanding of what is required to partner successfully with government sponsors. They will provide ICON a platform to further penetrate this market segment as part of our strategy to grow and diversify our customer base. ClinicalRM's experience in responding to the challenges of global viruses will further enhance ICON's capabilities in the areas of Vaccines and Infectious disease, benefiting our customers and patients globally." Victoria Tifft, Chief Executive Officer of ClinicalRM added, "We are delighted to be joining ICON. By combining ClinicalRM's expertise in government sponsored research with ICON's breadth of services and global footprint we will be able to bring additional services and thought leadership to our customers. We are also excited about the potential the combination has to further innovate drug development in the area of Vaccines and Infectious diseases, important areas of focus for both government and commercial customers."   ]]> https://biospectrumindia.com/news/97/8291/sartorius-stedim-biooutsource-appoints-technical-sales-specialist-in-india.html https://biospectrumindia.com/news/97/8291/sartorius-stedim-biooutsource-appoints-technical-sales-specialist-in-india.html Thu, 30 Jun 2016 11:51:24 +0530 Sartorius Stedim Biotech (SSB), announced that its subsidiary BioOutsource has appointed Mr Ravin Mehta as Technical Sales Specialist to enable customers to have access to Cellca and BioOutsource's early stage development services for biosimilar drug candidates. Prior to joining BioOutsource, Mr Ravin spent over 10 years in biosimilar product development, where he gained experience in cGMP manufacturing as an upstream bioprocess scientist with two of India's major biopharmaceutical companies. He also attained skills in management by supporting biologics development services for WuXi AppTec, one of Asia's largest biopharma firms. His technical expertise is underpinned by a degree in biotechnology from Saurashtra University and an MBA in marketing from The Maharaja Sayajirao University of Baroda. Mr Ravin Mehta, Technical Sales Specialist at BioOutsource commented: "I am excited to be utilising my knowledge and experience of the Indian biosimilar industry to bring Cellca and BioOutsource's leading portfolio to biopharma firms here." Mr Mitch Scanlan, Director of Sales and Marketing at BioOutsource concluded: "India is a growing market for vaccine and biosimilar production and we are expanding our technical team to meet the need for accessing our unique services here. We're delighted to have recruited a biosimilar expert like Ravin because he can explain how our analytical expertise can help scientists enter clinical programmes more rapidly and provide a competitive edge with their biologics' development."   ]]> https://biospectrumindia.com/news/97/6803/grand-challenges-explorations-india-first-call-for-proposals.html https://biospectrumindia.com/news/97/6803/grand-challenges-explorations-india-first-call-for-proposals.html Wed, 29 Jun 2016 17:23:22 +0530 The Biotechnology Industry Research Assistance Council (BIRAC), the Department of Biotechnology (DBT), Government of India in collaboration with the Bill & Melinda Gates Foundation and IKP Knowledge Park (IKP), a science park and start-up incubator announced the first call for proposals under the Grand Challenges Explorations India (GCE-India) programme. "The GCE-India programme aims to address challenges that are faced by the Indian healthcare system by encouraging innovative solutions to tackle the same. We are looking for ideas that have the potential to change how people look access healthcare in India. GCE-India looks to foster entrepreneurship in India. Our goal is the search for drug delivery systems, diagnostics, and technology enabled service models and medical devices that can potentially be made accessible to all," said Prof K VijayRaghavan, Secretary, DBT. The programme is seeking ideas in the following areas: contraceptive discovery platforms; new therapies for childhood cryptosporidium infection; preservation of stool samples for room-temperature transport and remote-analysis; global burden of antimicrobial resistance; point-of-care nucleic acid diagnostics below $2 per test; and self-testing for cervical cancer and malaria diagnostics. The awardee will be eligible for an award of INR 50 Lakh for 18 months, and a prize of INR 10 Lakh for successful completion of milestones. Successful projects will also have the opportunity to apply for follow-on funds from BIRAC through the Biotechnology Industry Partnership Programme (BIPP), Small Business Innovation Research Initiative (SBIRI) and/or the GCE Phase II program of the DBT, BIRAC and Bill & Melinda Gates Foundation.   '"GCE-India is looking to empower potentially life-changing ideas and enable scale-up. Our network of highly qualified individuals will work with innovators to help refine strategy and provide technical consulting. Through this programme, we aim to identify nurture and empower revolutionary ideas that address global health challenges" said Dr Deepanwita Chattopadhyay, Chairman & CEO at IKP Knowledge Park. Apart from the funding, BIRAC and IKP Knowledge Park will closely work with the chosen candidates; provide them technical and business strategy advice, as also access to synergistic networks within the nation and outside; factors that would be critical to making an innovation a medical and commercial success. "GCE-India is the platform which will enable idea generation and help translate research into action. If India is to stand shoulder to shoulder with the larger economies, it is important that it becomes self-sufficient. Therefore, we expect that healthcare innovation from within the nation will be able to address the needs of the country better; GCE-India is a search to identify healthcare innovations in India that will enable standardized healthcare for all irrespective of where they seek it," said Dr Steven Buchsbaum, Deputy Director, Discovery & Translational Sciences, Bill & Melinda Gates Foundation. This Call for Proposals is open to everyone, from any discipline from India. The applicants may be researchers and faculty in colleges/ universities/government laboratories/ institutions to startups and SMEs as well as non-profit organizations. The program is accepting proposals until 11:59 PM, June 30, 2016 (IST). For information on eligibility, application process and selection criteria, please visit www.gce-india.org.   ]]> https://biospectrumindia.com/news/97/3768/sartorius-acquires-cell-screening-specialist-intellicyt-.html https://biospectrumindia.com/news/97/3768/sartorius-acquires-cell-screening-specialist-intellicyt-.html Wed, 29 Jun 2016 10:39:58 +0530 Sartorius, a leading international pharmaceutical and laboratory equipment provider, today announced the acquisition of US based IntelliCyt Corporation, an award-winning innovator and manufacturer of novel cell screening platforms used in drug discovery. Through the acquisition, Sartorius expands its current lab portfolio into bio analytics, thus substantially strengthening its offering for biopharma customers and academia. Sartorius purchased IntelliCyt for $90 million in cash, which includes approx. $5 million in future tax savings. The company focuses on pharma, biotech and academic customers, and achieved strong double-digit annual growth during the past few years. Based in Albuquerque, New Mexico, USA, IntelliCyt currently employs 55 people and is expected to generate sales revenues of more than $18 million in 2016 (2015: $13.4 million) and to break even on underlying EBITDA by year-end 2017. "Novel cell screening methods are crucial to enable scientific progress in the fast-expanding research areas of immuno-oncology, antibody discovery and immune targets. IntelliCyt has developed a powerful platform that integrates instruments, reagents and software seamlessly across the workflow. This is a great addition to our laboratory products portfolio", said Mr Joachim Kreuzburg, CEO of Sartorius. Welcoming the transaction, Dr R. Terry Dunlay, the founder, President and CEO of IntelliCyt, said, "By coupling the global market presence and strong infrastructure of Sartorius with IntelliCyt's enabling cell analysis platform, we will be better able to deliver value to our customers, further penetrate our core markets, and grow the business to the next level."     ]]> https://biospectrumindia.com/news/97/8114/medtronic-acquires-heartware-international-for-1-1-bn.html https://biospectrumindia.com/news/97/8114/medtronic-acquires-heartware-international-for-1-1-bn.html Tue, 28 Jun 2016 11:18:03 +0530 Medtronic and HeartWare International,announced that the companies have entered into a definitive merger agreement under which Medtronic will acquire HeartWare in a transaction valued at approximately $1.1 billion. Under the terms of the agreement, Medtronic will commence a tender offer for all outstanding shares of HeartWare common stock for $58.00 per share, in cash. The boards of directors of both Medtronic and HeartWare have unanimously approved the transaction. The acquisition is expected to close during Medtronic's second fiscal quarter ending Oct. 28, 2016, subject to the satisfaction of customary closing conditions. Medtronic's acquisition of HeartWare will expand Medtronic's portfolio of diagnostic tools, therapies and services for patients suffering from heart failure, aligning with Medtronic's Mission of alleviating pain, restoring health and extending life, and is in line with the Company's strategy to surround the physician with innovative products while focusing on patients and disease states. HeartWare's flagship product, the HVAD System, features the world's smallest full-support ventricular assist device (VAD) and is designed to reduce surgical invasiveness, improve patient recovery times and enhance patient outcomes. In addition, HeartWare has multiple technologies in development designed to offer progressively less-invasive mechanical circulatory support options for patients with end-stage heart failure. Medtronic estimates that the global VAD market is approximately $800 million currently and worldwide is expected to grow in the mid-to-high single digits for CY16-17, and accelerate to high-single/low-double digits beyond CY17. "The addition of HeartWare's innovative portfolio adds to our expanding portfolio of diagnostics, therapeutics and services that address heart failure patients," said Mr Mike Coyle, executive vice president and president of the Cardiac and Vascular Group at Medtronic. "The team at HeartWare has established excellent relationships with its hospital customers and built a strong position and reputation in the marketplace. This transaction, once closed, will be a further, important step toward Medtronic offering a complete suite of solutions to address patient needs across the heart failure care continuum."'   "Medtronic is the worldwide leader in cardiovascular device technologies. Its expansive expertise in the development of implantable systems and battery technologies, patient monitoring, manufacturing, global regulatory policy and commercialization should help accelerate the development and introduction of our innovative pipeline products, and will expand access to our therapies and offerings to the sizeable heart failure population," said Mr Doug Godshall, president and chief executive officer, HeartWare. "Combining the unique capabilities of the HeartWare team, which has been entirely focused on mechanical support technologies, with the broad strength of the Medtronic organization provides a unique opportunity to enhance growth in the mechanical circulatory support market. All of our stakeholders, including customers, employees, shareholders, and most importantly, patients, will benefit meaningfully from this complementary combination." "HeartWare's HVAD System enhances the portfolio of our Cardiac & Vascular Group, a team with a proven track record of executing and a demonstrated ability to scale early stage concepts into large, sustainable end markets," said Mr Omar Ishrak, chairman and chief executive officer of Medtronic. "In addition, from a financial perspective, we are pleased to reach an agreement that meets our acquisition criteria of adding minimal to no net EPS dilution in the near-term, while at the same time creating strong, long-term expected returns for our shareholders." This transaction is expected to meet Medtronic's long-term financial metrics for acquisitions. Medtronic's financial advisor for the transaction is J.P. Morgan Securities LLC, with Ropes & Gray LLP acting as legal advisor. HeartWare's financial advisor is Perella Weinberg Partners LP, with Shearman & Sterling LLP acting as legal advisor.   ]]> https://biospectrumindia.com/news/97/8241/indian-e-pharma-obstructed-with-muddled-regulatory-norms.html https://biospectrumindia.com/news/97/8241/indian-e-pharma-obstructed-with-muddled-regulatory-norms.html Wed, 22 Jun 2016 12:54:37 +0530 Online pharmacies emerging in India have met with major concerns regarding the misuse of technology, safety concerns on electronic prescriptions and opposition from offline chemists faced by the industry. The Indian Internet Pharmacy Association (IIPA), is leading the Indian e-pharma players to bring to notice and resolve the roadblocks raised by the regulatory bodies. While the IIPA members strive hard to follow regulations and operate legally, it has taken up as its mission to clarify that it is not the non-adherence of regulations, but the lack of a proper regulatory framework that has become a stumbling block e-pharma startups. The pharmaceutical business falls under the Drug and Cosmetics Act, 1940. The IPA members have requested the sub-committee created by the 48th Drug Consultative Committee formed in July last year, by Drugs Controller General of India (DCGI), to formulate guidelines on the use of technology in pharma. The committee was expected to submit the report within three months (by October last year), but has not come up with even the draft report yet. The Maharashtra Food and Drug Administration (FDA) filed an FIR against Mchemist Global Pvt Ltd and has also asked to maintain a strict vigil on all activities conducted by the epharma companies. There are regular probes and raids at office spaces, where employees are frisked and threatened. Mumbai-based Pharmeasy, Delhi-based M-chemist and Mera Medicare in Gujarat had recently faced police investigations and FIRs. The industry has been losing about 50-60 percent business because of being stringent with prescriptions and renewing requests. India's pharmaceuticals industry is expected to account for about 3.1-3.6 percent of the global pharma industry by value, and currently accounts for 10 percent by volume. (Source: Make in India Statistics) The $18-billion pharma retail market is set to grow to $55 billion by 2020 and is fast coming under the spotlight due to its growth potential in the coming years. Online e-pharma startups in India have already raised $92.6 million in funding so far. Currently, India has about 45-50 e-pharma startups, major players being 1mg.com, Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com (PM Health & Life Care), SaveOnMedicals and Savemymeds. ]]> https://biospectrumindia.com/news/97/3794/research-support-byod-approach-in-clinical-trials-.html https://biospectrumindia.com/news/97/3794/research-support-byod-approach-in-clinical-trials-.html Mon, 20 Jun 2016 11:05:56 +0530 ICON has announced research showing many pharmaceutical and clinical research organisations (CROs) support the use of a 'Bring Your Own Device' (BYOD) approach in clinical studies, enabling patients to use their own mobile devices to collect patient-reported outcomes (PRO) data. The research highlights how commonly-cited concerns around the use of patients' own devices are not as much of a deterrent to adoption as is often thought. There are two main areas of concern in using a BYOD approach for PRO data collection in clinical studies. The first relates to equivalence and how different device sizes and operating systems might affect the measurement properties of a PRO instrument. The second relates to the technical and practical aspects of using a patient's own device, including data capacity, upgrades to operating systems and a change of device mid-study, which could negatively impact PRO data collection. ICON's research, completed in association with Medidata and mProve Health, measured attitudes towards these perceived concerns and provides industry with further information to devise future strategies for BYOD adoption. The survey measured attitudes from 79 respondents from biopharma, CROs, ePRO providers, patient advocates and research institutions. The survey results found that biopharma and CRO professionals appear to be significantly less deterred by challenges of equivalence and the practical and technical challenges associated with BYOD in clinical studies. Survey highlights include: • Only 44% of respondents thought that equivalence should be demonstrated on all possible devices used in a BYOD study. • The majority of respondents agreed that demonstration of equivalence on a single device specification was acceptable as long devices with smaller screen sizes or screen resolutions could be prevented. Only 30% of respondents disagreed with this approach. • Over 75% responded that they were "not at all concerned" or only "a little concerned" about issues such as a PRO app being deleted, inadequate storage space for PRO data, or the trial participant becoming distracted by other apps on their device during PRO completion. • Over half (53%) were not concerned that people may be able to turn off notifications, such as diary reminders, and 74% were not worried about trial participants changing their phones mid-study. "As a CRO that is at the forefront of innovating the clinical trial process, we wanted to research industry perceptions towards BYOD, an approach that has the potential to greatly enhance patient engagement and compliance," commented Mr Willie Muehlhausen, ICON's Vice President eCOA and Head of Innovation. "We are encouraged by the research findings which show support from biopharma and CROs for the adoption of BYOD models. We will continue to investigate this important area and work with industry partners and regulatory authorities to provide evidence and guidance to make BYOD a fully endorsed approach."   ]]> https://biospectrumindia.com/features/97/8406/exclusive-does-india-need-a-precision-medicine-initiative.html https://biospectrumindia.com/features/97/8406/exclusive-does-india-need-a-precision-medicine-initiative.html Wed, 15 Jun 2016 12:39:58 +0530 During his State of the Union address in January 2015 at the White House in Washington DC, American President Mr Barack Obama announced the launch of the most ambitious Healthcare initiative called the Precision Medicine Initiative (PMI), a mission to usher the US into a new era of medicine where patients will enjoy individualized and tailor-made treatments for various ailments. Mr Obama said, "Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood type - that was an important discovery. What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring out the right dose of medicine was as simple as taking our temperature?" Too Early For India? Precision medicine is an emerging approach of medicine which looks at the root cause of an illness, rather than addressing the symptoms alone. Precision medicine may not be very well known as Personalized Medicine. But they are one and the same. It takes into account individual variability in genes, environment, and lifestyle for each person. The need and its potential in the Indian Healthcare scenario is high, considering that the system is under great pressure due to sheer numbers. Precision Medicine in the country is considered to be at an early adoption stage. A diverse country like India, with over 4000 population groups, and a significant percentage of consanguineous marriages presents a high-risk and prevalence of inherited genetic disorders that require attention for early diagnosis, right treatment, and management. India has a heavy burden of inherited diseases driven by the unique genetic characteristics in the population. With 1.4 billion people, the absolute number of patients suffering from diseases in which genetics play a role is significantly large.   It is reported that Indians witness a loss of around $23 billion from their annual income in treating or getting tested for non-communicable diseases. The global Genomics industry is predicted to grow at around 18% in the next 10 years, and India is expected to be a major stakeholder. Revenue growth in molecular diagnostics in 2013 was reported to be around 15%. Clinical diagnostics in one of the fastest growing fields which may cross $2 billion by 2018. Preventive healthcare is growing at the rate of 25%, which will boost Healthcare revenues and the country's Precision Medicine scenario. "Genetic testing is slowly getting acceptance among our clinicians. The challenges are about creating the awareness for wide-spread adoption. It is not at all too early for the country to embrace precision medicine. This is primarily because India is an emerging market for genomics. A rising middle-class, state-of-art healthcare facilities and expert physicians are driving the growth of the industry in India.... I expect the industry to attain double digit growth," says Mr Sam Santhosh, Chairman & Global CEO, MedGenome. Dr Saleem Mohammed, CEO & Founder, Xcode Life Sciences, agrees that India has a strong need for Precision Medicine which will significantly reduce its Healthcare burden. "It is estimated that only around 40% of the medicines we take are effective and appropriate for us. Today, we practice trial-and-error medicine which does not consider in detail the person-to-person variability, which is a key source of variation for the effectiveness of drugs. You can imagine being dosed and prescribed by taking into account various factors such as age, gender, genetics, medical conditions and usage of other drugs. That is the promise of personalized medicine, and India needs to take leadership in this domain," he adds. In India, Precision Medicine is being practiced in several specialties like oncology, cardiology, psychiatry and diabetology. It is already being embraced in India to a reasonable extent, especially in cancer. "Each individual is an island, and so now that the molecular complexity of disease has been deciphered, the role of genetics, environment and epigenetics are clearly telling us that that we all need to receive treatment designed for our physiology and body type," remarks Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen. Indian Healthcare institutions are fast adopting technologies that can make them on par with the best in the world. The need to modernize, and be on par with global standards can be seen amongst large hospitals and private medical institutions. Explains Dr Kalyanasundaram Subramanian, CSO, Strand Life Sciences, "There are several targeted therapies that work only on patients who have a specific genotype or genomic variation. So, patients are tested before the therapy is prescribed. Cancer is probably the disease in which precision medicine is most advanced. However, there are several other diseases - cardiac, ophthalmic, and certain types of diabetes, where knowing the genetic background of the disease can help with disease management. Here the field is not as advanced." Like most technologies, India is expected to be a follower-market in Precision Medicine. Doctors would like approval from USFDA or the American Medical Association (AMA) for it to become mainstream in their practice. But the challenge is that the West is going to fund studies in Caucasian population and not the Indian. In fact, most drugs are designed and manufactured for Caucasian population. Unless India accelerates research in this space, validation in the Indian context will always be questionable. "Precision medicine is badly needed to move towards personalized medicine and personalized diagnostics, which has a huge potential to reduce the burden of national healthcare costs," points Dr Amit Kumar, CEO & CSO, BioAxis DNA Research Centre. "At several instances, this results in patients selling assets or borrowing money to pay incurring medical expenses. Precision medicine is the best available tool and remedy for combating this huge economic burden." Cost of these tests are a concern still, given India is largely a self-paid economy. But as technologies improve, the cost of sequencing is seen to reduce. Precision Medicine offers a possible answer by reducing the costs of hospice stay, and reducing the overall financial, physical and psychological costs of the try-and-test approach of medicine. "The infrastructure needed for precision medicine is taking shape in India. There are certain issues to be addressed for it to gain the needed momentum," opines Mr Samarth, CEO & Founder, Positive Bioscience. "The key is also the analysis of genomics data, which as we automate will provide higher efficiency in the entire data analysis process, thereby making tests more affordable. We do need more baseline genomics data of Indian origin which will help us in refining our analysis on clinical cases in the country," comments Mr Sam. Targeted therapies like Imatinib have been around for 40 years. This has changed the prognosis of Chronic Myeloid Leukemia (CML) in children. "People used to think that the role of genetics ended with hereditary disease. Today we know that every response our body makes has a genetic fingerprint to it. We can now predict response to different therapies, and thus avoid trial-and-error medicine which is both costly, time-consuming, and puts an unnecessary drug and hospitalization burden on the patient," comments Dr Sooraj Ratnakumar, Founder & Scientist, Swagene. The US and EU markets do have a head start in Personalized Medicine in terms of accessibility to resources and raw materials, government funding, and regulations. "There is also greater awareness among the people there about the benefits of personalized medicine. In India, we have an excellent gene pool of biotech and IT professionals. With government interest, we can easily build India as the hub of personalized medicine," expresses Ms Anu Acharya, CEO, Mapmygenome. President, CEO & Founder of Genotypic Technology Mr Raja Mugasimangalam says that Precision Medicine is too early for India at the moment. "Precision medicine is an emerging field and sufficient success should be shown by the western world for India to embrace it. It is in its early phase, and there is not sufficient government support in the form of research grants in this space," he adds. Overly Hyped? The way Precision Medicine can help transform Healthcare, especially treatment and management of deadly non-communicable diseases is tremendous, and stalwarts opine that it is not an overly hyped concept. "The field of precision medicine is still in a nascent stage in India, and much needs to be done to create awareness. So the concept cannot be called as overly hyped, but rather passionately acclaimed in the medical and scientific fraternity. Any development in the science and medical space that revolutionizes how medicine will be practiced in the future naturally generates a buzz around it. Yes, the concept is quite novel at this point of time but its scope is tremendous. While we may lack the bandwidth to carry out all the exceptional research at this point in time, slowly it will happen. And once it happens, the impact will be more than just overwhelming. However, there are certain roadblocks that we cannot ignore. But limitations and challenge begets innovation and development," opines Mr Samarth. "I see precision medicine as a new hope rather than a hype," Dr Amit states. "Some of our clients say that research insights of the genomics data-related to lifestyle, diet, and clinical methods have been very useful in making a decision faster based on a patient's personalized genetic information." More than hype, Precision Medicine is said to be more of plain, pure common sense. For thousands of years, humans have known that there is inter-individual variability when it comes to things ingested, be it medicine or food. Why then patients pop an over-the-counter pill? Or even wonder whether it will work on them or not? In a recent study by Johns Hopkins University (USA), medical error was suspected to be the third leading cause of death in the US. Many of them are related to improper drugs and improper drug dosages. "It's sort of like 'death by medicine'. Can you imagine what the statistics are in India? asks Dr Saleem. "Today, we don't question why the outcome was negative for a patient. We assume that the medical establishment did the best they can in good faith. With increasing prevalence of clinical decision support systems, and insurance insisting on good practices, you will see things improve. Common sense dictates that precision medicine is the only way medicine should be practiced and not by trial-and-error." Dr Binay Panda, Chief Officer & Head, Ganit Labs, also states that the problem in India is that Precision Medicine is hyped by people who understand little about it. "Look around and you will find folks who talk about precision medicine, who understand little about it or have very little practical and scientific experience on developing precision medicine tests. We need rigorous scientific minds to talk about the utility of precision medicine, like in the west, and not those who use the term as a buzz word or a part of marketing supplements only," clarifies Dr Binay. India's Research Scene The research scene for Precision Medicine in India is largely in the beginning stage. Some studies are being carried out in various translational research centres across the country. There are several Government laboratories such as IGIB (Institute of Genomics & Integrative Biology), CCMB (Centre for Cellular and Molecular Biology), hospitals such as CMC Vellore, LV Prasad Eye Institute and other organizations, where research is being conducted. "However, it would be fair to say that the research is fragmented and individual researcher-driven, and not yet translated to patient care in a big way," points Dr Kalyanasundaram. Research is also being carried out at Sir Gangaram Hospital (Delhi), Madras Diabetes Research Foundation (MDRF) (Chennai), Indian Council of Medical Research (ICMR), Institute of Bioinformatics (IOB) (Bangalore), and Government institutions such as National Institute of Biomedical Genomics (NIBMG) and Center for Genome Research. Large Government hospitals like Tata Memorial Hospital, National Institute of Mental Health and Neurosciences (NIMHANS), and All India Institute of Medical Sciences (AIIMS) are also involved in the identification of new disease genes and biomarkers by applying Genomics. Dr Mallik Sundaram, Co-founder, President & CEO, Mitra Biotech, says, "The western markets have embraced it quickly because healthcare is more organized there with the payers being the government or insurance companies, thereby translating the benefits of decreased healthcare costs while improving treatment success rates using precision medicine. In countries like India with fragmented healthcare, and the patient frequently being the payer, while the benefits remain the same, but acknowledging and translating them is more piecemeal." India, like many other developing countries, is following success stories of the West. "Success in precision medicine depends on several factors including availability of tests on precision medicine, system on which medical payment is made -- out-of-pocket versus insurance-based versus government-sponsored -- overall positive atmosphere in the country towards embracing new tests, previous success stories, availability of skilled manpower and the presence of the right environment. On all these accounts, we in India, have miles to go. However, we have excellence in pockets, which include brilliant people who are capable of doing all that. The trick is to encourage those few to develop tests for the Indian population," Dr Binay explains. Paradoxical Elements The use of Precision Medicine is a little tricky and paradoxical, say experts. "It has lot of social impact. But someone has to draw a line to the extent one should use it. One single mutation is responsible for more than one medical condition and vice versa; it may also create confusions and misleading interpretations. Precision medicine may be only a corroborative aspect until we have more confidence, and accurate outcomes getting reported across the globe," Dr Amit reveals. Dr Kalyanasundaram says that the challenge is in marrying personalization of medicine with reduced drug costs to an individual patient. "Currently, most of the best genome-based medicines are expensive and out-of-reach for the average Indian. The other worrying aspect is that none of these medicines are available in India. Imagine the plight of a patient who realizes that there are medicines that may work for him but is unable to access it," he observes. Also, the discussion of paradoxes of Precision Medicine often revolves around the cost, i.e., spending more and more to identify therapies that applies to fewer and fewer. Mr Samarth adds, "This paradox can be compared to the cost of any IT initiative in the eighties era using mainframe computers, and specially created buildings for housing them versus, even higher computational processing being available today in a mobile system; or 3D printing to give a more recent example. As there is a change in approach and increase in use of the technologies, there will be a reduction in costs." What Is Needed? In Precision Medicine, for successful commercialization, many things have to come together. "There has to be a way of leveraging all the information and insights that is generated in other populations from around the world. The Indian government should be setting up large genomic studies in various disease populations. Indian scientific establishments needs to view this as a challenge, and work with physicians to understand the diseases that are most likely to have benefits quickly, and work towards problems in those areas. Indian funding agencies should be funding large translational projects with a clear clinical aim. There should be clear frameworks that allow industry to access these insights to convert them to products," urges Dr Kalyanasundaram. Both Mr Sam and Mr Samarth agree that increasing the awareness levels of Precision Medicine among the general population, clinicians and doctors is much needed. "In our country, the depth and width of the healthcare system is very large, often unorganized, and under tremendous pressure. To bring in a new approach to the practice of medicine will need full participation and education of patients, drug developing pharma companies in pharmacogenomics, change in the practices and process of hospitals and clinics, good regulatory framework and the support of the government in building the research infrastructure. Further in order to translate the bench research to bedside care, it is important for research academics and medical market players join hands," suggests Mr Samarth. Collaboration of genetic testing laboratories, hospitals, and medical doctors may be the starting point, says Dr Amit. "We require huge genetic, clinical and lifestyle data from India, and this can only be reached if governmental programs backup such kind of association and research. With the fast decreasing cost of DNA sequencing of a person's genome, a model shall be framed which should have genetic medicine and precision therapy as one of the most important inclusion. Government may think of including genetic tests under the insurance coverage, starting with critical illnesses. If we have enough country data, it may offer a lot of very important medical insights." According to Dr Binay, India needs 4 Ps to make Precision Medicine succeed. "They are people, processes, protocols and pricing. People meaning encouraging and aiding brilliant minds to be involved in developing new and innovative tests; processes meaning developing the right clinical and scientific processes or SOPs; protocols meaning coming up with the right regulatory...," he lists. Dr Saleem believes that the medical community should actively collaborate with genetic service providers to validate concepts in the Indian population. "We operate in a highly cost-sensitive environment. A key barrier to adoption is cost of the test.... In the long-term, genetics should become a major part of the medical curriculum. Genetics should get its due importance given that we live in an era where we are talking about actively editing genes to cure major diseases," he notes. Mr Sam recommends public-private partnerships (PPP) between academic institutes and the industry to promote genomic research in the country. "Partnerships with private enterprises that have already taken the leap into genomics research and are providing solutions to address health care needs in India.... In addition to this, initiatives like setting up of electronic medical records, and population level genome sequencing will go a long way in helping commercial success. It will also be useful to chart out a comprehensive plan to identify key disease areas in India with underlying genetic reasons that have high unmet medical need and to allocate government funds to promote education, research and innovation in these areas," he stresses. Should India Ape The US? India may follow something similar to PMI launched by Mr Obama, but on a pilot scale. "The government can play a key role by allocating research funding to this area. Precision medicine is going to have a tremendous impact on our nation's healthcare and will improve health outcomes while minimizing the costs. But someone has to make the investment in accelerating the creation of know-how, and the knowledge base that is specific to India. Given the significance of health for a nation's economic and social development, I would say that prioritizing of government grant funding to this area will be highly useful. The US again has taken leadership in this so far with the precision medicine under the Obamacare," voices Mr Samarth. In an interview with BioSpectrum, Dr Mandar Kulkarni, CTO, Cancer Genetics India, states, "I think this is a big challenge even in the US, where most diagnostic testing is paid through insurance reimbursements, which are driven by FDA-approvals." He further expresses, "Currently, the FDA is reviewing the guidelines and ensuring that the testing is not wasteful. On the other hand, a major advantage for such testing in the US is the availability of well-curated databases that define the effect of mutations on the disease-state in terms of prognosis, clinical outcome and treatment options. Unless we adopt the tests and begin this exercise, we will not be able to identify epidemiological and etiological differences that contribute to cancer in India." Though India's limited studies in this area show that while the Indian genome has many similarities to the Caucasian, there are significant differences as well. "So it is absolutely essential that a similar and large PMI be launched in India given the genomic diversity here," justifies Dr Kalyanasundaram. Mr Sam also agrees that a initiative like PMI will be useful to India's Healthcare. "If a similar program is initiated, it has to be designed keeping in mind the state of the economy, and the public health issues of the Indian population, and the diseases or disorders plaguing our society. The GenomeAsia 100K consortium is one such initiative in the region," he urges. Starting anything new is good, but India needs to revive and encourage what it already has, and have a long-term vision for Personalized Medicine. "Science does not bear fruit overnight," Dr Binay adds. "One needs to be patient and encourage funding the right talent in this direction. First and foremost, we need to encourage young minds to pursue science and be more meritocratic in our institutions." Dr Amit emphasizes that both ICMR (Indian Council of Medical Research) and CSIR (Council of Scientific and Industrial Research) need to play a very important role in framing the insights related to pharmacogenomics, genetic variation-related drug studies, and population-wise human SNP validation, if India wants a meaningful outcomes from such a diverse population. Dr Raja says that India doesn't have to ape the West. One might consider a PMI in India as an overly zealous move for a country where malnutrition and poverty collectively kills more people than diseases. "At the right time we can definitely think of taking a step towards PMI for our own country just like America. India is already the diabetes capital of the world and is slowly inching in vying the top spot for heart ailments and cancer too. I think we all have come to appreciate the fact that all these diseases are genetic-driven by a combination of several mutations in different genes. Precision medicine guided by genomics not only allows us to diagnose and prevent these diseases but also treat and manage them effectively," elaborates Mr Samarth. Regulatory Woes Genomic information is critical since it not only affects an individual but potentially their family as well. There are legal, technical, social, and political hurdles which needs to be addressed. Dr Kalyanasundaram stresses, "It needs to be clear who owns this information, what are the limitations under which researchers get access to it, and how can this information be used and misused. These issues are all critical and need to be addressed by the law." However, the current regulatory frameworks are inadequate in terms of providing guidelines for Precision Medicine initiatives. Information is required on how to bring in a population level-approach for Genomics research. Also, policy revisions to support the industry from import duties on reagents are a need of the hour. "Intellectual property rights and patent policies are not very well defined in the area of precision medicine and predictive genomics. This could be a challenge to further innovation. Also, reimbursement from insurance companies is another key factor that will determine the growth of this industry. In the western world, insurers have started accepting genomic tests in their formulary as it is expected to reduce the cost of down-the-line treatment. In India the option is to bring the test at affordable prices and foster innovation to reduce the cost of genomic diagnosis," Mr Sam expresses. Precision Medicine is dependent on the DNA Study of an Individual, and India does not have a DNA usage policy yet. "We are hoping for the best since this important master molecule has caught the attention of our PM Narendra Modi, and he has announced to put all the efforts towards the DNA Bill of India. Again, draft of this Bill also needs to be concreted by including insights from industry experts, academicians, research organizations, laboratories and judiciaries," justifies Dr Amit. Dr Binay strongly supports in having strong ethical guidelines to practice Precision Medicine. Degree Of Impact Just imagine a patient taking a simple blood or saliva test at a laboratory, and in the next meeting his or her physician is very well prepared with the patient's genetic horoscope including the information on chemical compounds, or combination of drugs useful or harmful to him, based on the tried-and-tested genetic test report. "We will be able to minimize side effects with very beautiful and faster accurate therapies that too at affordable costs if precision medicine boosts up in India..... If used responsibly, it can do wonders and contribute towards every individual's good health," notes Dr Amit. Precision Medicine can also transform the national economy, especially in a population whose average lifespan is increasing. Mr Sam explains, "From an individual's perspective, it has the potential to make genetic diagnosis of diseases more efficient and cost-effective, by reducing genetic testing to a single analysis, which informs individuals throughout their life. Since it uses state-of-the-art genomic technologies, rich medical record data, tissue and blood banks, and clinical knowledge that will allow clinicians and payers to tailor treatments to individuals, it can greatly reduce costs of ineffective therapies incurred through the current trial-and-error clinical paradigm." The impact can be great, where patients get the right medications, have better outcomes and lower side effects, feels Dr Kalyanasundaram. "This would lead to healthier populations with better overall health economics. To make this possible, lots of information needs to be collected, analyzed and translated. Medicines that can exploit the genetic differences need to be present. So the task is formidable but the payoffs are potentially enormous." Precision Medicine will also allow reduced morbidity, specifically in oncology cases, help in preventing high burden of genetic diseases, and managing high-risk cases with increased surveillance. It will also have a major impact on the economy by reducing productivity losses, and decreasing costs of treating disease, thereby reducing overall costs on Indian Healthcare. "The internet will further accelerate adoption of precision medicine by empowering patients and doctors who are already demanding more to fight India's unique challenges with diabetes, heart disease and tobacco use," said Dr Sooraj. In 2012, Futures Group predicted a new perspective to Healthcare by 2050, where gaps between medical practice, healthcare, and personal health will be bridged. Another prediction is the predominance of preventive healthcare, where individuals take charge of their health by harnessing the power of technology. Genomic tests - single nucleotide polymorphism and whole genome sequencing - will be the key catalysts to this change. "We have seen the beginning of this change. Wellness was once a fancy word. Today, it is part of every hospital's business strategy to engage a new generation of customers, who are actively pursuing wellness using social apps for various reasons - right from fitness and diet to finding the best doctor," opines Ms Anu. In India, diseases have a profound physical, psychological and social impact. Most of healthcare costs are paid not out of insurance, but out of pockets. The impact of illness in one person in the family has a domino effect on the family and the community. "The cost of treatment, for diseases like cancer, cardiac diseases, diabetes, asthma, and the impact of the side effects of medication taken has often seen families, even amongst middle-class and higher middle-class, needing to take loans, or family members having to leave jobs," Mr Samarth states. "Just the simple factor of reducing treatment time and side effects will have a significant impact on the socio-economic situation of an individual." So, diseases that were previously a death sentence will be manageable, or even curable, because we will be able to individualize therapy for each patient. ]]> https://biospectrumindia.com/news/97/7317/ge-launches-biacore-molecular-interaction-analysis-platform.html https://biospectrumindia.com/news/97/7317/ge-launches-biacore-molecular-interaction-analysis-platform.html Tue, 14 Jun 2016 11:02:57 +0530 GE Healthcare's Life Sciences business launched the first of a next generation of Biacore systems harnessing Surface Plasmon Resonance (SPR) technology. Biacore 8K marks the start of a new generation of Biacore systems maintaining the high data quality expected from Biacore at high throughput. New design features efficiently address current industry challenges such as understanding complex targets in drug discovery. Label-free SPR analysis is a vital tool in the scientist's analytical toolbox, providing a dynamic understanding of how molecules interact and enabling a thorough understanding of drug/target interactions. This new platform further enables the use of SPR throughout drug discovery, development, and manufacturing. Biacore 8K specifically supports small molecule and biotherapeutic screening and characterization with the quality of affinity and kinetics data scientists expect, increasing operational efficiency. "As users push the boundaries of SPR, we are working closely with them to deliver the type and speed of analysis that they are looking for," commented Ms Cindy Collins, CEO/GM, Protein Purification & Analysis and Cell Therapy for GE Healthcare's Life Sciences business. "We are also seeing an increase in the use of label-free SPR-based analysis in the immuno-assay area, replacing traditional ELISA-based methods and some cell-based assays. Supporting early-stage complex biotherapeutics development is also in demand, as well as process development and quality assurance." Biacore 8K is the first of a new generation platform specifically developed to deliver enhanced productivity and performance up to eight times faster1, simply. Completely redesigned hardware and software takes label-free SPR-based analysis well into the future, delivering high-quality data that supports better and faster decision-making across all areas of drug discovery2, including small molecule and biotherapeutic screening and characterization.   ]]> https://biospectrumindia.com/news/97/6921/parexel-announces-services-agreement-with-pfizer-.html https://biospectrumindia.com/news/97/6921/parexel-announces-services-agreement-with-pfizer-.html Fri, 10 Jun 2016 15:38:13 +0530 PAREXEL a leading global biopharmaceutical services provider, today announced that it has signed a services agreement with Pfizer Inc. Under the terms of this agreement, PAREXEL will continue to provide global clinical research and development services to Pfizer in support of clinical development programs across its portfolio. Terms of the agreement were not disclosed. "PAREXEL will continue to leverage its proven clinical processes and expertise to help Pfizer conduct clinical trials and accomplish its drug development goals," said Mr Josef von Rickenbach, chairman and chief executive officer, PAREXEL International. "Our team is focused on applying dynamic and innovative operational models to help Pfizer develop drugs to improve health and treat diseases for patients around the world." As an innovator in creating strategic partnerships in the biopharmaceutical services industry, PAREXEL uses a spectrum of relationship models to meet the diverse requirements of clients. This includes large companies as well as emerging companies through its BioPharm unit.     ]]> https://biospectrumindia.com/news/97/7430/frontier-mediville-to-pioneer-in-manufacturing-mechanical-artificial-hearts-in-india.html https://biospectrumindia.com/news/97/7430/frontier-mediville-to-pioneer-in-manufacturing-mechanical-artificial-hearts-in-india.html Fri, 10 Jun 2016 10:51:16 +0530 Chennai: On May 23, 2016, Dr K M Cherian of Chennai-based Frontier Mediville signed an MoU with SPUTNIK, Russian Federation for the manufacture of a mechanical artificial heart. It is to be noted that SPUTNIK, the Russian organization, was responsible for launching the 1st Space Shuttle on Oct 1957, which took the Americans by surprise and now the company has further excited the World by creating mechanical artificial hearts. The MoU was signed with Mr Sergey Sannikov in the presence of Padma Bhushan Dr A Sivathanu Pillai, Father of Brahmos Missiles. According to the memorandum, it will be possible to produce the mechanical artificial heart within the cost of INR 30 lakhs, which will be very cheap and affordable to many in the world compared to the others. At the press briefing, Dr Cherian, said, "There are more than one lakh patients who had artificial hearts last year in North America alone. The latest artificial heart cost Rs 90.5 lakhs including implantation and it goes beyond 1.25 crores. It is essential for the hospital to have a standby heart in case if the implanted one fails. So the actual cost for the hospital /patient is around 2.5 crores. As you can imagine how many of our 1.2 billion population can afford it? The artificial hearts are made in US by Heart Mate, Thoratec Corporation, California, USA and in Germany by Berlin Heart GmbH. Both are equally effective but expensive." SPUTNIK is very keen to manufacture this mechanical artificial heart in Mediville as the company believes that Mediville has the entire infrastructure, especially a large facility for pre clinical studies which are going on as per CPCSEA approval projects which have approved projects by CPCSEA. Thus with the technology available as well as the facilities, Russians believe that these artificial hearts could be made very cheap and will be available for supply to all over the world. The Memorandum is for a Joint Venture, and if it materializes, India will be the 1st Asian country and 3rd country in the world to produce its own artificial heart and of course the standing of Tamil Nadu as a MECCA in the field of Medical Care will be enhanced. ]]> https://biospectrumindia.com/news/97/7022/india-should-benefit-more-from-clinical-trials.html https://biospectrumindia.com/news/97/7022/india-should-benefit-more-from-clinical-trials.html Thu, 09 Jun 2016 11:58:41 +0530 India has some of the highest brain power in the world and should benefit more from conducting larger number of clinical trials of new drugs under development, said Dutch expert Prof Meir Perez Pugatch while presenting the global trends on BioPharma at the Ministerial meeting of the International Council of Biotech Associations (ICBA) meeting during the BIO International conference in San Francisco. Presenting a global study on BioPharma competitiveness, Prof Pugatch said clinical trials accounted for nearly 70 per cent of the global research and development (R&D) spends of pharmaceutical companies. And clinical trials are a fundamental and crucial component of the BioPharma innovation system globally. According to the global data prepared by the Pugatch Consilium, of the nearly 150,000 clinical trials currently going in the world, India is conducting just 2,835 trials. Compared to the population size of India, this is miniscule, he said. In a lively discussion on this issue, ABLE team narrated the sequence of events since 2012 that slowed down the clinical trial approval process and shared the new guidelines on Clinical Trials that will be announced by the government, removing some of the barriers induced by court directives in the past few years. USA leads the world with ongoing 92,787 clinical trials, followed by Canada (15,268), Germany (14,302), UK (11,899), China (7,602), South Korea (7,109) Australia (5,135), Brazil( 4,952), Japan (3,950), Rusia (3,336), South Africa (2,175) and Singapore (1,587) among the major clinical trial destinations.   (Source: ABLE)   ]]> https://biospectrumindia.com/news/97/7434/personalized-medicine-for-children-with-blood-cancer-launched-by-swagene.html https://biospectrumindia.com/news/97/7434/personalized-medicine-for-children-with-blood-cancer-launched-by-swagene.html Wed, 08 Jun 2016 12:12:02 +0530 Swagene, a specialty molecular lab in Chennai, is said to be the first and only centre in India to launch some of these advanced biomarkers in India to benefit children suffering from leukemia. Blood cancer, or leukemias, are complicated because of the large number of 'driver' genetic mutations seen in the disease. These mutations affect the disease in terms of severity, survival, and risk of relapse. Apart from detecting the disease and determining its course, identifying the mutation in the patient is crucial to also provide targeted treatment protocols. "When a patient is accurately stratified, giving him/her targeted treatment can vastly improve success rates. For the first time in India, Swagene is launching such a diagnostic panel that can help many children, who are commonly affected by leukemia", explained Dr Vani, Swagene's co-founder. Swagene is said to the first and only lab in India that offers IKAROS (IKZF1) and ERG deletion tests for leukemia patients. Being sub-microscopic mutations, these can be detected only by molecular diagnosis and not by conventional methods. The lab being a specialized molecular diagnostic centre founded by a scientist and a doctor, is also able to quickly report test results with detailed interpretation. It is expected that these two tests, which can also be ordered as a panel, will vastly improve the oncologist's and hematologist's armamentarium in fighting cancer successfully. The mutations or biomarkers can be either favourable (good) or poor (bad) depending on how they affect the cancer. These bad markers, such as IKAROS or IKZF1 mutations, are important in identifying patients at risk of treatment failure and giving them stronger or modified therapy to prevent relapse. A lot of scientific evidence show that tailoring the treatment to suit these patients using currently available drugs is greatly beneficial in improving survival.   Dr Vani further said, "In this case, there is also a silver lining. There is a good marker (ERG mutation), that is a hero because it has the power to overcome the villain IKZF1. If the hero mutation is present even in the presence of the other the patient will fare a lot better." So patients that carry both are still classified under favourable prognosis. This is particularly helpful in deciding which patients may need bone marrow transplantation, the mainstay of leukemia therapy. This is very stressful for the patient because not only does identifying a matching donor take a long time, but it is also too expensive even for the insured classes. Swagene has won numerous awards from CII, FICCI and DST, as well as institutes like IIT Kharagpur, IIM Ahmedabad and BITS Pilani.   ]]> https://biospectrumindia.com/news/97/3469/dexterous-robots-with-3-d-vision-to-assist-in-surgeries-in-over-100-hospitals-by-2020-.html https://biospectrumindia.com/news/97/3469/dexterous-robots-with-3-d-vision-to-assist-in-surgeries-in-over-100-hospitals-by-2020-.html Tue, 07 Jun 2016 17:44:03 +0530 Robotic Surgery is set for rapid growth as more and more hospitals embrace new-age, computer-assisted, surgical robots. By 2020, more than 100 hospitals across 25 Indian cities, are expected to get dexterous robots with 3-D vision to assist in surgeries Robotic surgeries provide succor to patients suffering from prostrate, gynecological, head & neck, lung and colorectal cancer as the chances of errors are minimized, procedures don't cause scarring and recovery is faster. Currently there are just 190 robotic surgeons in India across 30 hospitals. The plan is to expand the pool of accomplished robotic surgeons to 500 by 2020 and cover 100 hospitals. A comprehensive plan, formulated by Vattikuti Foundation, addressing three critical components--surgeon training, geographic reach and complete packages, which benefit the economically weaker sections--was announced here, today, by its founder Raj Vattikuti, a US based IT entrepreneur and philanthropist. Among others present at the event who highlighted the benefits of robotic surgery were Dr Arun Prasad, Senior Consultant Surgeon, Minimal Access Surgery, Apollo Hospital, Dr Praveen Bhatia, Senior Consultant, Minimal Access & Bariatric Surgery Centre, Sir Ganga Ram Hospital, Dr Rajesh Ahlawat, Chairman, Urology and Renal Transplantation, Fortis Escorts' Hospital and Dr Sudhir Rawal, Rajiv Gandhi Cancer Institute & Research Centre, Director Surgical Oncology & Chief of Uro - Gynae Surgical Oncology. The plan is tailor-made for India, as the number of cancer cases has risen alarmingly but only 36 per cent of the reported cases got treated. Moreover, nearly 76 per cent of cancer patients hailed from non-urban areas, where access to cancer detection and treatment is a distant dream. The need therefore is to expand the pool of trained surgeons to non metro cities. "We will grow the pool of accomplished Robotic surgeons to 500 besides motivating young surgeons to adopt robotic surgery. As its contribution, Vattikuti Foundation, will offer 100 paid fellowships to super specialist surgeons, over the next 5 years, to become Robotic surgeons," says Raj Vattikuti, who has been evangelizing Robotic Surgery in India since 2010 through The Vattikuti Foundation. "Even though 4,000 robot-assisted surgeries were performed in 2015, representing a five-fold increase in 5 years, India has not even scratched its potential, as the benefit can be passed to the masses beyond metro locations," adds Raj Vattikuti. Vattikuti Technologies, which makes available da Vinci Surgical Robots, from Intuitive Surgical Inc. in India, will work with Government Cancer hospitals, Corporate Healthcare chains, and Trusts, to acquire the most appropriate Surgical Robots. Vattikuti Technologies shall enhance access to Robotic surgery, covering specialized cancer centers, large government hospitals and small hospitals in Tier-2 and Tier-3 cities. In the North, the Foundation will be targeting Bhopal, Delhi NCR, Jabaplur, Lucknow, Ludhiana, Varanasi and Srinagar. "Vattikuti Technologies and Intuitive Surgical shall work together to offer hospitals special price points as they achieve 450 procedure mark over three years. This move will ensure availability of cancer surgery closer home for patients at prices that make robotic surgery affordable to the masses," says Gopal Chakravarthy, CEO, Vattikuti Technologies. Adoption of Robotic Surgery by government hospitals will ensure treatment to people who can't afford private healthcare but deserve the latest medical attention. The government hospitals typically adopt a dual pricing system--charge only those who can afford. Robotic Surgery in India: The Journey So Far In the last 5 years, multi-disciplinary Robotic Surgery has established its value in India with documented superior patient outcomes and efficacy. The Vattikuti Foundation has helped expand Robotic Surgery to 30 hospitals in a dozen Indian cities, in just five years, while the number of trained robotic surgeons has grown to 190. Vattikuti Foundation began promoting Robotic Surgery in the US in 1997 and has since played a stellar role in spreading it across the USA, Europe and India. Under the Vattikuti Foundation program, surgeons working at the Vattikuti Urology Center at Henry Ford Hospital in Detroit developed procedures for Prostate Cancer surgery which has become the Gold standard--Robotic Prostatectomy--in the US. Since then the Foundation has been working with surgeons around the world to pioneer various Robotic procedures including one for kidney transplant, developed co-operatively by Indian surgeons from Hospitals in Delhi and Ahmedabad. Indian surgeons have been adapting to this new-age tool with great enthusiasm and skill. At the recent Robotic Surgeons' conference hosted by the Foundation, over 120 Robotic Surgeons participated and shared their experience and techniques. Robotic Surgery Benefits Robotic surgery scores over conventional surgery, as it minimizes blood loss, drastically reduces the post-operative recovery time, and brings precision in executing the procedure, thus saving healthy tissue from damage. The quick healing and lower pain-levels translate to shorter hospital stays and quick return to work. Surgical Robots combine the best of science, engineering and medicine. With 4 arms, it can reach organs and areas where human fingers can't. The 3-dimensional view, that can be magnified multifold, helps the surgeons achieve precision that prevents collateral damage to healthy tissue. The single most important benefit of robotic surgery is quick recovery. If the patient is back home on third day, instead of say ten days' recovery period of conventional surgery, a daily wage earner can get back to productive work much earlier, while the hospital can increase the efficiency of operations. There is little to no pain, as Robotic arms enter the body via tiny incisions, healing is quicker for the patient, scarring is minimal and savings on pain management are significant. As the incidence of tongue and mouth cancers are very high in India, Head and Neck surgery for cancer at the base of the tongue can best be undertaken using the Robot, with least pain and scarring to the patient. ]]> https://biospectrumindia.com/features/97/8113/significant-shifts-in-skill-sets-for-top-it-roles-in-life-sciences.html https://biospectrumindia.com/features/97/8113/significant-shifts-in-skill-sets-for-top-it-roles-in-life-sciences.html Tue, 07 Jun 2016 12:53:19 +0530 More than 80 percent of leading life sciences companies have created new digital and innovation leadership roles to capitalize on the information technology transformation in healthcare, with nearly half hiring new chief information officers during the past three years, according to new research by the IMS Institute for Healthcare Informatics. The rise of mobile, cloud, predictive analytics and other digital innovations offers new opportunities for advancing patient care as companies launch innovative products at a more rapid pace and in more therapy areas. These dynamics, along with spending and operational constraints, require life sciences CIOs to expand specialized IT knowledge and skills within their organizations, and to play a more strategic role in driving commercial success through digital transformation. The study, New Strategic Information and Technology Roles in Life Sciences Companies, includes a proprietary Information and Technology Transformation Scoring framework (ITTS) to assess progress among the top 50 global life sciences companies. ITTS tracks five areas of technology conversion: Innovation/Disruption, Organizational Transformation, Big Data/Analytics, Infrastructure, and Future of Work.   The study was produced independently in collaboration with Egon Zehnder, a leading global executive search and talent management firm. "While most life sciences companies have centralized their IT functions to drive operational gains, they have been slow to achieve the breakthrough transformation that's possible by capitalizing on today's technologies," said Mr Murray Aitken, IMS Health senior vice president and executive director of the IMS Institute for Healthcare Informatics. "Of the companies we assessed using our ITTS framework, just 15 percent are fully capturing the value of the digital revolution." "Tech and digital innovations are becoming a core part of the value proposition for life sciences. And yet, unlike many other industries, the skills required to fully deliver on those innovations are not native within this sector. There is a unique opportunity for CIOs to fill the missing skill gap and become core enablers of their respective companies' strategies," said Mr Alain Serhan, co-leader of Egon Zehnder's global Digital Health Initiative.Highlights of the study include: • Technology transformation is underway within all life sciences companies, across varying strategic and operational areas, and at different rates. Large companies outperform their medium-sized competitors on average across all elements of the ITTS assessment. Of the companies surveyed, 15 percent are considered market leaders, demonstrating significant progress on both strategic and operational dimensions. On average, 85 percent of companies with centralized IT functions have achieved a higher level of technology transformation-as have companies that use cloud-based technologies for more than 25 percent of their software needs. • While IT departments are embracing analytic tools that reduce complexity, advanced predictive and prescriptive capabilities remain underused. Within sales and marketing functions, 80 percent of companies assessed now have systems in place that leverage visualization tools, and more than half have a multichannel marketing strategy in place for their North America and Europe operations. However, fewer than 10 percent of life sciences companies deploy systems that apply both predictive and prescriptive capabilities to guide decisions. • As leadership in new IT functional areas is recognized as increasingly critical to success, CEOs are hiring new CIOs and establishing digital and innovation roles. Nearly half of the life sciences companies assessed have CIOs who have been in place less than three years, and 70 percent in place fewer than five years. In small companies, more than 40 percent of all CIOs were hired within the past year. Companies with CIOs having a tenure of less than five years outperform on the ITTS framework overall, especially in the key areas of Innovation/Disruption and Big Data/Analytics. More than two-thirds of today's CIOs were hired from outside the company, with external hires ranging from 82 percent for small companies to 52 percent for larger organizations. Despite the critical role of the CIO in business transformation, less than one in four are part of their company's executive team. Within large life sciences companies, just one in seven CIOs serves on the executive team. • CIOs remain in the best position to lead technological innovation, but require new digital competencies. The CIO role has narrowed in scope in most life sciences companies as responsibility for areas such as R&D bioinformatics, genomics and Real-World Evidence have moved to other parts of the organization. And, more than 80 percent of companies have established new digital data and innovation positions that challenge the traditional CIO role. With new "digital" competencies viewed as key for success, assessments by CEOs of CIO candidates focus on a combination of both core and digital competencies. The core competencies of strategic orientation, results orientation, team leadership and collaboration/ influence remain essential. In pursuit of future digital leaders, CEOs also are seeking candidates with strengths in consumer centricity, digital fluency, data orientation, adaptability and change leadership. ]]> https://biospectrumindia.com/news/97/4048/datwyler-to-open-its-most-advanced-firstline-production-site-in-india.html https://biospectrumindia.com/news/97/4048/datwyler-to-open-its-most-advanced-firstline-production-site-in-india.html Mon, 06 Jun 2016 12:31:17 +0530 Datwyler, a leading supplier of customized sealing solutions to manufacturers and companies which operate in the health care and automotive industry, as well as the market segments civil engineering and consumer goods, has announced the construction of its most advanced manufacturing facility - FirstLine - at the Datwyler India site in Satara, Maharashtra. The FirstLine facility will be integrated in the existing premise, and will be fully operational in 2017. An additional area of 24,000 m2 is available for future growth. The most complex rubber components produced at the FirstLine site belong to the Omniflex family of vial and syringe components, which prevent any interaction with the drugs due to their total fluoropolymer coating. These components are exclusively manufactured at the FirstLine sites. The Omniflex coating process is a Datwyler proprietary process. Omniflex is an inert, flexible, fluorinated polymer coating for pharmaceutical rubber closures, which covers the entire product surface. The chemical inertness of the fluorinated polymer coating provides a very high degree of compatibility with pharmaceutical or biotechnology products. Datwyler India will supply the products made in the FirstLine production facility in Satara to the company's customers worldwide. Mr Rahul Dev, Vice President, Datwyler India said, "Datwyler's latest investment in India through the commencement of the FirstLine facility in Satara is part of the company's commitment to India and the Asian markets. Present in India since 2010, Datwyler is dedicated to guaranteeing the highest levels of quality and safety, and continues to make investments aimed at meeting global regulatory requirements. The plant currently employs 290 people. It will employ 350 people by the time the production starts in 2017." Mr Dev further added, "India's pharmaceutical and biotech markets are evolving rapidly and have been able to gain traction from global manufacturers, suppliers and customers. The country is also getting recognised as one of the global manufacturing destinations. Our new FirstLine facility in Satara makes a great business case for us as we look at catering to global markets. Datwyler is one of the leading producers of closure solutions for injectable and vial medicines. The company's products are supplied to the world's leading pharmaceutical and biotechnology companies to support their efforts towards save and effective drug delivery for a healthier world."   The health care unit of the Datwyler Sealing Solutions division designs, develops and manufactures solutions for injectable packaging and drug delivery systems to facilitate customers to create a safer medical environment. In addition to the Omniflex series, vial stoppers of different sizes as well as plunger stoppers will be produced in this FirstLine facility.   ]]> https://biospectrumindia.com/interviews/97/8292/betting-big-in-indias-bioseparation-space-.html https://biospectrumindia.com/interviews/97/8292/betting-big-in-indias-bioseparation-space-.html Mon, 06 Jun 2016 12:31:03 +0530 The company's president Mr Anthony J MacDonald, who was formerly with Pall Corporation, recently visited India in setting up and overseeing the company's establishment in Bangalore. Spectrum Labs makes products and services to the Biopharmaceutical and Pharmaceutical industry. It majorly manufactures filtration, purification and separation-related products. He exclusively spoke to BioSpectrum's Raj Gunashekar offering a glimpse into Spectrum's India expansion strategies, further investments, plans on M&As, and the market outlook. The company, a private firm, was founded in 1970, and is headquartered in Los Angeles, California, USA. It has 3 manufacturing sites in the US, along with an engineering site, and 2 logistics sites, totaling up to 6 campuses in the US alone.   Spectrum Labs also has a satellite office and a logistics center at Netherlands in Europe, which started in 1999. In 2012, it ventured into China, and the same year extended its European office further. In January 2016, India witnessed the entry of Spectrum Labs into the country in Bangalore city. "Our intention in India is to help customers, and grow with them in the Biotech and Biopharma space. We directly want to service our customers. The type of products we make involve a lot of interactions with them, and we want a crystal clear understanding of their requirements and provide the necessary services," voiced Mr Anthony MacDonald, President, Spectrum Labs. Currently, the bioseparation industry is seeing a major trend, which is, going from the traditional fed-batch fermentation process to perfusion fermentation, a continuous process. Mr MacDonald added that India has multiple growth driving factors for the company.   "Firstly, a lot of companies are expanding vaccine manufacturing in a big way here in India. Then there is Biosimilars entering the Indian market in a big way. They are going to be our growth drivers in India," he commented. When asked about the company's strategies in handling competition from small and medium enterprises (SMEs), Mr MacDonald shared, "We make our separation technology in a competitive manner, which is best in the US and Europe. We compete well with the SMEs and take on the challenge. When we bump into them, we always see what their advantages are and play on those. We ensure customers see the value of our products and services." He feels that running a business in India will bring in its own unique challenges. "We are getting familiar on how to do the business in India. There are a lot of regulatory challenges. We have an experienced director here in India who is now guiding us. Indian market is different from other markets. When we opened our China office in 2012, it was quite a learning curve. We use that as a blueprint in conducting business in India. We apply that concept and work with the local consulting group. People say Chinese market is hard. Yes, it is! But India has more pages of regulations to work with. Indian market is not necessarily difficult but you just need to know how to, and be familiar with the market," he explained. The company's President also revealed that Spectrum Labs will expand further within India in a stronger way.   He opined, "We are profit-driven. We want to get to a profitable stage in India. Once we are there and can maintain a good sustainability, we are going to add other sites in India. But for now, first we want to build the business in Bangalore. Once we are up and running here, we will invest in other sites. We are working on that right now. Our next destination could be metros like Chennai, Hyderabad, or Mumbai." Spectrum's R&D happens predominantly in the US. It invests a significant 2% to 5% of its revenues into its R&D annually. "As we expand further, our R&D will happen at various centers. Our technology is evolutionary, and we are working along with our customers. Our R&D product development comes from the field, and from our technology sales force, and also from the in-house engineering teams," Mr MacDonald expressed. Most of the company's revenues is generated from the US markets. He highlighted, "But the revenue percentage will decline as we grow further. For example, 12 years ago, our revenues from North America was 80%. Today, it is down to 60%. The rest of the world contributes 40%.   "Right now our Asian revenue stands at 15%. But, in the next few years, Asia will represent over 30%. "We also believe that our distribution revenues will be 40% in the US, and 60% from the rest of the world. In the next 5 years or so, out of this 60%, Asia and Europe will contribute to 30% each." The company has a plethora of reasons in choosing Bangalore as an entry point to the Indian market. "Bangalore is the home to the IT industry. As we grow and invest in business, IT is going to play a bigger part in it. Companies who are competing with us are also based in Bangalore. It's a home to our type of industry, and the weather is simply perfect," Mr MacDonald justified. As of now, the company is very bullish about the Indian market. "We invest a lot of time and money in membrane technology and its applications. We are looking forward to work with Indian customers in the Biotech, Biopharmaceutical and Pharmaceutical industries to help them grow. Our market is the separations industry, which is a multi-billion dollar market. We are a segment of the separations industry, and the Indian market is a subset of that. The market will grow with the Biopharmaceutical space. It is in fact going to hit a solid double-digit in India," he held. Will the company take M&A route in India? "Yes," Mr MacDonald stated. "We are open to M&As. We cannot share anything about it at the moment. But we do have plans for M&As in India." ]]> https://biospectrumindia.com/news/97/8129/ppd-appoints-veteran-bioanalytical-leader-as-immunochemistry-head-.html https://biospectrumindia.com/news/97/8129/ppd-appoints-veteran-bioanalytical-leader-as-immunochemistry-head-.html Thu, 02 Jun 2016 11:27:47 +0530 Pharmaceutical Product Development (PPD) has announced that Bruce Stouffer has joined PPD as executive director of immunochemistry in the PPD Laboratories' bioanalytical lab. "Bruce brings extensive experience and strong leadership skills to our talented immunochemistry team," said Dr David Johnston, executive vice president of global laboratory services for PPD. "As a recognized industry leader, Bruce is an exceptional asset for our clients' research programs." Mr Stouffer previously served as director of analytical and bioanalytical development for Bristol-Myers Squibb, where he managed a group of scientists with responsibilities including contract operations, quality control, and small and large molecule bioanalytical project management. Previously, Stouffer was responsible for the bioanalytical sciences late-phase group, responsible for management of post-Phase II bioanalysis, as well as support for new chemical entity (NCE) filings. Mr Stouffer spent the early part of his research career in biomedical sciences as a technologist and lab supervisor at Roche Biomedical Labs. In 1982, he joined the Squibb Institute for Biomedical Research, developing immunoassays to support numerous small and large molecule programs for Bristol-Myers Squibb.   ]]> https://biospectrumindia.com/news/97/8030/perkinelmer-opens-new-customer-knowledge-center.html https://biospectrumindia.com/news/97/8030/perkinelmer-opens-new-customer-knowledge-center.html Thu, 02 Jun 2016 11:27:26 +0530 PerkinElmer held an opening ceremony for its new Taipei Customer Knowledge Center (CKC) located in Neihu District, Taipei City. President of PerkinElmer's Environmental Health business, Mr Jon DiVincenzo, as well as Vice President and General Manager of Global Sales and Service, Nam-Hoon Kim, hosted more than 70 guests from the environmental, chemicals and semiconductor testing industries and academia, along with PerkinElmer representatives from the Asia-Pacific region. This new Taipei CKC is a relocation and expansion of PerkinElmer's presence in Taiwan, where it has been present for more than 25 years. The facility is located in a convenient and ideal location for offering support and services to customers. It contains PerkinElmer's innovative detection and analytical instruments for providing instrument demonstrations, sample analysis, application testing, method development, education and training in food safety, environmental testing, and industrial applications. "Opening this new Taipei CKC in an area where many of Taiwan's technology industry is situated is a strategic investment that enables us to further connect with our customers and partners," said Mr Nam-Hoon Kim. "We look forward to sharing our products, services and expertise with them and delivering the tools and knowledge to help them facilitate better outcomes in environmental health." PerkinElmer's customers in Taiwan include academic institutions, government agencies, foundations and large corporations -- spanning electronics, semiconductors, petrochemicals, food, materials engineering, chemical industry, pharmaceuticals, inspections, biotechnology, medical, and other industries.     ]]> https://biospectrumindia.com/news/97/3279/innovations-for-the-indian-market.html https://biospectrumindia.com/news/97/3279/innovations-for-the-indian-market.html Thu, 02 Jun 2016 11:26:21 +0530 The innovations included categories under prevention, diagnosis, treatment, healthy living and homecare products. The newly unveiled products were Children's Respiration Monitor, Air Purifier Series 3000, Air Purifier Series 6000, Fetal Heart Rate Monitor, Dream series of sleeping aids, and e-alert System. According to the company's release, both the Fetal Heart Rate Monitor and the Children's Respiration Monitor were developed at Bangalore's PIC. But the e-alert system was developed at Philips Healthcare Innovation Centre (HIC) in Pune, which employees 500 professionals. Both the products is said to be manufactured at HIC.   Philips Healthcare's focus and innovations encompasses the following health spaces: cardiology, oncology, respiratory, fertility, pregnancy and parenting. India maintains a leadership position in cardiovascular diseases (CVDs), diabetes and cancer. "We are addressing diseases in India with locally made products," said Mr Raja Venkataraman, Vice-Chairman and MD, Philips India. The country currently has 60 million CVD patients, 2 million cancer patients, and leads in orthopedic ailments. There are 4.3 million deaths globally due to indoor air pollution. Of this, 1.3 million deaths are associated with India. According to a recent study, 27.5% of under-five infant mortality in India is because of indoor air pollution. India is also home to 22 million COPD (Chronic Obstructive Pulmonary Disease) patients, and about 8 million of them in stage-3 or stage-4 condition. Out of the 8 million, 1.3 to 1.4 million patients hail from metros like Bangalore, Chennai, Delhi, and Hyderabad. Smoking is said to be a major contributing factor for COPD. "We aim to touch 3 billion lives by 2025. That's our vision," explained Mr V Raja. "We have designed products to suit the Indian market. In healthcare, it is ironical that there are no incentives for making in India. The Government keeps increasing the import duty on medical equipments. It doesn't work that way. We need technology, market, cost competitiveness and an ecosystem which will enable making it for the benefit of patients and the industry. In fact, years ago, the Government created a synergistic ecosystem for the software industry by providing lands, incentives, and an overall conducive ecosystem leading to the huge success of that industry. If the same would have been offered to the healthcare sector, a similar success story would have repeated in India." Mr Raja took on his new role at Philips in December 2015. In the personal healthcare area, 50% of the company's portfolio is manufactured in India. "In the next 2 to 3 years, we aim to take it to 75%," added Mr A D A Ratnam, President, Personal Health and Head, Brand, Communications and Digital, Philips India. In September 2014, the Dutch conglomerate Philips NV split into two separate entities -- Philips HealthTech-Lifestyle and Philips Lighting. The latter made a shining IPO debut on May 27, 2016. ]]> https://biospectrumindia.com/news/97/8224/medtronic-strengthens-commitment-to-asia-pacific.html https://biospectrumindia.com/news/97/8224/medtronic-strengthens-commitment-to-asia-pacific.html Wed, 01 Jun 2016 12:04:06 +0530 Medtronic announced the opening of its new Asia Pacific regional headquarters in Singapore. The new facility, which houses the Asia Pacific Service and Repair Centre of Excellence, will strengthen and support Medtronic operations across 80 locations in Asia Pacific. This will further help Medtronic deliver on the growing demand for medical products and services. With the opening, Medtronic International Limited signed a Memorandum of Understanding with SingHealth to develop a Centre of Excellence in the treatment of diabetes across Southeast Asia. "The opening of Medtronic regional headquarters in Singapore marks an important milestone in our growing presence in Asia Pacific. We continue to leverage our regional expertise and partnerships to reach more patients, in more places and through more ways via collaborating with new partners," said Mr Bob White, president, Asia Pacific at Medtronic. "The rising prevalence of diabetes in the region is driving up healthcare costs and adversely impacting the lives of millions of people. There is tremendous opportunity to improve treatments across the diabetes care continuum via meaningful innovation and collaboration. We are excited to work with SingHealth as our strategic partner to explore new approaches in solving challenges associated with diabetes care." The alliance will pair Medtronic expertise in advanced diabetes management solutions with SingHealth's experience in holistic diabetes care in order to:• Establish a Center of Excellence on diabetes to advance treatment and care management in the region• Enhance patient education and access to innovative technology for diabetes management • Deepen regional education and trainings for physicians on the latest technology to manage diabetes• Become a leader in facilitating adoption of new technologies that improve patient outcomes• Lead new initiatives and collaborations to transform diabetes care delivery and management "Some of today's most pertinent healthcare challenges such as rising healthcare costs and a rapidly ageing population call for new approaches and models. With its sizeable presence in Singapore, we welcome Medtronic's contributions in this multi-stakeholder effort to transform healthcare," said Ms. Thien Kwee Eng, assistant managing director, Singapore Economic Development Board (EDB). "We believe this will set a strong precedent for industry to participate actively in co-creating new healthcare solutions out of Singapore, which will benefit healthcare in Singapore and the region."   ]]> https://biospectrumindia.com/news/97/8279/boston-scientific-conducts-awareness-and-screening-camps-.html https://biospectrumindia.com/news/97/8279/boston-scientific-conducts-awareness-and-screening-camps-.html Tue, 31 May 2016 18:02:50 +0530 Over 1000 people received free check-ups and counselling for digestive problems at patient screening camps that were held in nine cities (Delhi, Kolkata, Bengaluru, Kollam, Hyderabad, Manipal, Kota, Ahmedabad and Indore). In these camps, leading medical devices company Boston Scientific India offered free check-ups and counselling for people with any digestive tract problems. Mr Prabal Chakraborty, Vice President and Managing Director, Boston Scientific India said, "Our mission "Advancing science for life" accurately reflects what we do for patients, physicians, and healthcare systems globally. Our intent behind this initiative was to encourage people to come forward and take charge of their digestive health, which is an often ignored and misunderstood area. For example, many individuals do not understand that a heartburn has nothing to do with the heart but is a form of indigestion. Parents are often unable to understand what might be wrong when their kid complains of a stomach ache. Problems in the digestive tract can be very distressful. But increased awareness about the causes and symptoms of common digestive health problems along with advanced medical devices and procedures leads to better prevention, diagnosis and treatment of digestive disorders." 1000 patients attended the awareness and screening camps. The gastrointestinal problems investigated were: Gastroesophageal Reflux Disease (GERD) that results in burning chest pain because of stomach acid backing up into the esophagus; Inflammatory Bowel Diseases (IBD) such as Crohn's Disease and Ulcerative Colitis that cause abdominal pain, diarrhea, rectal bleeding, weight loss and fever; Irritable Bowel Syndrome that causes persistant stomach pain lasting several months; hemorrhoids that cause bleeding while passing stool; and anal fissures that have symptoms similar to those of hemorrhoids. Some patients suspected of gall bladder stones and bile stones were advised to come back for further endoscopic procedures. At the screening camp doctors also shared tips on how to maintain a healthy gastrointestinal tract and explained the need for procedures such as an endoscopy when it came to diagnosis.   ]]> https://biospectrumindia.com/news/97/7017/glenmark-launches-digital-dose-inhaler.html https://biospectrumindia.com/news/97/7017/glenmark-launches-digital-dose-inhaler.html Fri, 27 May 2016 11:53:34 +0530 Glenmark Pharmaceuticals has announced launch of Digihaler - India's first Digital Dose Inhaler (DDI)." This next-gen inhaler provides accurate digital dose counter along with low dose warning indicator to enable Asthma and chronic obstructive pulmonary disease (COPD) patients to track adherence to their therapy. As per WHO estimates 2007, there are 300 million people currently suffering from asthma globally, and it is expected that could increase by further 100 million by 2025. There have been 2,50,000 deaths per year globally and 57,500 deaths per year in India. On the occasion of the launch, Mr Sujesh Vasudevan, president and head of India Formulations & Africa Region, Glenmark Pharmaceuticals, said, "We feel Digital revolution will play a central role in the industry. Especially in Asthma and COPD disease, were patient's non-adherence to treatment regime is age old challenge worldwide, and also one of major reason for inadequate control of asthma and COPD across age groups. Digihaler is "India's First Digital Dose Inhaler (DDI)", aims to address this age old challenge, the device will enable the patients to track the number of doses that have been consumed and prominently placed indicator provides a low dose warning which is beneficial to patients. This will further enable the doctors to determine patient's adherence to the prescribed therapy regime." He added, "Digihaler also addresses the issue of pseudo-adherence & tail-off phenomenon which leads to poor outcome of the therapy. Pseudo-adherence is when patients thinks that he/she taking their medication but in reality is just activating a nearly empty canister. A "tail-off" phenomenon occurs when patients continues to use the inhaler beyond the recommended number of doses and the drug delivery per actuation becomes inconsistent and unpredictable, with the amount of active drug eventually becoming negligible." He added further, "With the launch of Digihaler, Glenmark is committed to provide innovative and world class products at affordable prices, and it further expands and strengthens our product offerings in the respiratory category too"   Digihaler, represents a next-gen inhaler which is "India's First Digital Dose Inhaler" (DDI). The device has DDI enabled with electronic dose metered kit which ensures 'Precise' or 'Accurate' delivery of dosage for 'Assured' benefits. The revolutionary Digital Dose Inhaler - DDI offers several benefits like low dose display forewarning the patient about the impending end of the 'recommended' doses, end dose display, so device can be replaced with a new one' and "Tail-Off" phenomenon.   ]]> https://biospectrumindia.com/news/97/8272/medtronic-qualcomm-collaborate-for-diabetes.html https://biospectrumindia.com/news/97/8272/medtronic-qualcomm-collaborate-for-diabetes.html Thu, 26 May 2016 11:35:36 +0530 Medtronic and Qualcomm through its wholly-owned subsidiary, Qualcomm Life, announced a global, multi-year collaboration to jointly develop future generation continuous glucose monitoring (CGM) systems that aim to improve health outcomes for people with diabetes. By giving insights to doctors and people with type 2 diabetes concerning glucose levels, the companies intend to enable more informed care, especially for those who do not have control of their diabetes today. The collaboration seeks to leverage Medtronic's market-leadership in diabetes management and Qualcomm Life's expertise in developing reference designs for wireless, single-use and small integrated modules to create more affordable, easier-to-use CGM systems, including a new sensor and smaller design that can provide near real-time and retrospective glucose data. The initial focus of the collaboration will be to develop a single-use CGM system designed for broader practice by general practitioners who manage care for the vast majority of the 400 million people worldwide with type 2 diabetes. This collaboration supports Medtronic's strategy to develop comprehensive CGM solutions that not only measure glucose but enable the delivery of actionable insights to both patients and providers.   Leveraging Qualcomm Life's deep wireless expertise and technologies, 2net(TM) Design is a platform for designing the communications components of connected medical devices, including disposable drug delivery devices and disposable diagnostic devices for condition specific connected therapies. "We believe that glucose should be a vital sign of diabetes health. Professional CGM is an increasingly used diagnostic tool that empowers physicians and patients with meaningful glucose data to tackle glucose control. Our solutions go beyond delivering data and provide automated observations and clinical decision support to help create a personalized care plan," said Ms Laura Stoltenberg, vice president and general manager, Non-Intensive Diabetes Therapies at Medtronic. "Our vision is to transform diabetes care so people with diabetes can enjoy greater freedom and better health. We are thrilled to be collaborating with Qualcomm Life - a best-in-class leader in wireless technologies that is ahead of the curve in a rapidly changing connected world - to develop innovative and affordable CGM systems that will fundamentally change type 2 diabetes management." "Qualcomm Life's connected health expertise along with our enabling 2net Connectivity Platform and 2net Design capabilities fit naturally with Medtronic's diabetes leadership in bringing future generation CGM systems to market," said Mr Rick Valencia, president and general manager, Qualcomm Life, Inc. "This collaboration furthers our commitment of enabling new connected care models that liberate vital data and unlock insights to deliver intelligent care wherever the patient may be." .   ]]> https://biospectrumindia.com/features/97/8306/global-contrast-media-injectors-market-to-more-than-double-to-1-8-bn-by-2022.html https://biospectrumindia.com/features/97/8306/global-contrast-media-injectors-market-to-more-than-double-to-1-8-bn-by-2022.html Wed, 25 May 2016 16:16:14 +0530 The company's latest report states that this rise, which will occur across 15 major markets, will mainly be driven by increases in the number of annual computed tomography (CT), magnetic resonance imaging (MRI), and angiography procedures, as well as growth in the utilization of contrast media injectors and increasing disease burdens. Ms Sarah Janer, GlobalData's Analyst covering Medical Devices, explains: "Contrast injectors can only be used alongside imaging devices, so the contrast media injector market relies on the growing demand for MRI and CT scanners. Indeed, as MRI machines are not normally packaged with an injector, hospitals must purchase MRI injectors separately from the suppliers. "CT contrast injectors, on the other hand, are usually packaged with CT scanner sales, so although the market for both types of injectors is growing, CT contrast media injectors experience higher replacement rates than new sales." The CT segment is the largest and fastest growing in the market and will rise at a CAGR of 12.3% during the forecast period, thanks to the rising popularity of CT imaging systems, which have become a standard for diagnostic imaging around the world. Single-head injectors make up the majority of the market's volume due to their low average selling price, which makes them especially attractive in emerging economies and hospitals that are pressed for funding. However, Ms Janer notes: "With the decline of CT injector prices in all sub-sections and geographies, GlobalData expects that dual-head injectors will experience high growth as hospitals seek to upgrade their injectors with more efficient models for lower costs." ]]> https://biospectrumindia.com/news/97/7814/consure-wins-usfda-clearance-for-qora.html https://biospectrumindia.com/news/97/7814/consure-wins-usfda-clearance-for-qora.html Wed, 25 May 2016 14:36:57 +0530 The company announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market three devices under its novel Qora Stool Management Kit (SMK) platform, to help manage faecal incontinence (FI) in non-ambulatory patients. FI is the inability to control bowel movements, leading to the involuntary and untimely release of faeces or flatus. It is an especially embarrassing and distressing condition for nearly 10 million US hospitalized patients and their caretakers. With current management options, patients are more likely to acquire bedsores, dermatitis, nosocomial infections and extend their length of stay in the hospital. Such facility acquired complications impact the CMS reimbursement received by these healthcare facilities, costing nearly 2 billion dollars annually.   Qora paves the way for an entirely new approach in the management of faecal incontinence, representing a $5 billion dollar market opportunity. Designed with the patient and user in mind, the Qora is the most comfortable, cost-effective, simple to use and versatile FI management device. With its patented technology, Consure brings together highly-motivated and capable team members, clinicians and investors focused on improving care for more than 100 million patients worldwide. The Qora SMK suite of devices comprising Qora Aeon, Qora AIM and Qora Arida, is designed to cover the spectrum of clinical needs observed in institutionalized FI patients. Consure's flagship product, Consure 120 SMS, had previously received clearance in 2014. Consure adds to this product line by introducing a short-term product, Qora Arida, and two long-term products, Qora Aeon and Qora AIM, which is MRI-compatible. These three line extensions offer an expanded faecal management portfolio for complex critical care patients and long-term acute or nursing care patients. Additionally, the new clearance allows for expanded use period for these devices, for up to 29 days. Qora uses proprietary technology that enables the device to safely divert liquid to semi-formed stool without interfering with patients' normal physiological function. The innovative design ensures hygienic device placement and dignified patient care. Consure Medical has received wide patent protection for its proprietary technology in key markets and continues to expand its patent portfolio. "We see our FDA clearance and successful product pilots at partner health centres as key milestones in helping manage faecal incontinence in a safer, more hygienic and compassionate manner," said Mr Nishith Chasmawala, CEO, Consure Medical. Backed by strong clinical evidence and supported by a talented team, Consure Medical is ready to scale up the product's commercialization in key geographies and establish Qora SMK as a new standard of care. "With our entirely novel approach to managing faecal incontinence, Qora is the first product that can be used beyond the critical care setting, offering a much needed management option for millions of patients suffering from faecal incontinence outside the ICU. The elegance of our novel technology is in its versatility and simplicity of use. Since Qora can be used with patients who have semi-formed stool or are being managed in step down facilities like LTACs, SNFs, and nursing homes, the market expansion opportunity is tremendous, nearly tripling the current number of addressable patients," Mr Chasmawala added. With the current reimbursement scenario, 20% of all US hospitals are being penalized for completely avoidable clinical complications like pressure ulcers and nosocomial infections. Medical device innovation targeted at improving healthcare quality outcomes, as well as the proactive adoption of such technology, will be instrumental in helping improve quality of healthcare around the world. . ]]> https://biospectrumindia.com/news/97/8347/state-of-innovation-study-finds-double-digit-increases-in-global-innovation-.html https://biospectrumindia.com/news/97/8347/state-of-innovation-study-finds-double-digit-increases-in-global-innovation-.html Tue, 24 May 2016 14:12:46 +0530 The pace of innovation among global corporations, universities, government agencies and research institutions has reached record levels. That's the finding of the 2016 State of Innovation Report: Disruptive, Game-Changing Innovation study, released today by the Intellectual Property & Science business of Thomson Reuters, the world's leading provider of intelligent information for businesses and professionals. Now in its seventh year, the annual study analyzes global intellectual property data, including worldwide patent application activity and scientific literature publications, as a leading indicator of innovation across 12 technology areas. This year's study finds a double-digit year-over-year surge in innovation growth, led by significant increases in the Medical Devices, Home Appliances, Aerospace and Defense, Information Technology, and the Oil & Gas sectors. The study also tracks global scientific literature publications as a window into the scientific and scholarly research that typically precedes discovery and the protection of innovation rights. Total scientific literature production, in contrast to overall patent volume, has posted a year-over-year decline, suggesting a potential slowdown in future innovation growth. Key findings from the report include: •Double-Digit Year-Over-Year Innovation Growth: Total, worldwide patent volume grew at an annualized rate of 13.7 percent in 2015, driving the overall growth rate for patents to over 100 percent since the State of Innovation study was launched in 2009. The total volume of new scientific research has declined 19 percent over the last year and 27 percent since 2009. •Medical Devices, Home Appliances, Aerospace & Defense Lead Growth: The industries showing the largest growth in year-over-year patent volume were Medical Devices (27 percent); Home Appliances (21 percent); Aerospace and Defense (15 percent); Oil & Gas (14 percent); and Information Technology (13 percent). •Biotechnology is Only Sector to Slow: The only sector in the study to log a year-over-year decline in patent volume in 2015 was Biotechnology, which saw a -2 percent move. •Open Innovation Models Thrive: The phenomenon of "open innovation" whereby corporations, universities, government agencies, and research institutions increasingly partner to bring new technologies to market, is evident in the increased comingling of multinational corporations and prolific scientific research institutions. These include, Procter & Gamble, listed alongside the University of Sao Paulo, the U.S. FDA, and Harvard University among top research institutions inthe field of Cosmetics, and Ford, listed alongside the University of Michigan and Polytechnic University of Turin among top researchers in the Automotive sector. "The last year has been marked by a series of epic breakthroughs: the first autonomous cars tested on public highways, the longest-ever human space mission, the first biosimilar drug approval - all of these were made possible by disrupting conventional boundaries and testing the limits of human creativity," said Mr Vin Caraher, president, Intellectual Property & Science, Thomson Reuters. "By consistently benchmarking innovation with concrete metrics on global patent and scientific literature production, we're able to get a clear outlook on future growth areas."   ]]> https://biospectrumindia.com/features/97/8336/hot-start-ups-a-saga-of-the-worlds-fastest-dna-rna-stain-.html https://biospectrumindia.com/features/97/8336/hot-start-ups-a-saga-of-the-worlds-fastest-dna-rna-stain-.html Mon, 23 May 2016 16:29:03 +0530 Both Dr Fathima Benazir (38) and Mr Alex Paul (38) were schoolmates and best childhood buddies. She was a postdoctoral research fellow at Indian Institute of Science (IISc), Bangalore, and was keenly looking out for opportunities abroad. She approached Mr Alex Paul and sent him her portfolio. The Unexpected Spark Intrigued by her profile and research accomplishments, Mr Paul persuaded her to apply her research to solve problems in different areas of Life Sciences. "I always wanted to be a passionate scientist rather than an entrepreneur," says Dr Fathima, Co-founder & CEO, Azooka Life Sciences. After several discussions and advice from her IISc mentors including Prof H S Savithri, Department of Biochemistry; Prof M R N Murthy, Molecular Biophysics Unit; and Dr C V Natraj, Advisor, Society for Innovation and Development (SID) IISc, she teamed up with co-founder Mr Alex and started Azooka Life Sciences in 2015.   The name 'Azooka' is derived from the Spanish word Azúcar, which means sugar in Brazil. Significance Of Nucleic Acid Stain The Bangalore-based start-up is said to be the discoverer of a patent-pending nucleic acid gel stain developed from a plant source used as a food additive. The fluorescent dye named 'tinto rang' is a nucleic acid dye available for applications in Biological Sciences and Genomics. Nucleic acid stains are a vital part of DNA-based disease detection compared blood-based disease diagnostics.   These stains are vital chemicals used in identifying diseases in human, animal and crop diseases. In fact, Nucleic Acid-based Testing (NAT) is a USFDA (United States Food and Drug Administration) approved and globally accepted methodology for non-invasive and rapid disease detection. NAT is said to be a precise and painless molecular testing technique. It is commonly available in the Americas, Europe, Malaysia and Thailand. "However this is not prevalent in India due to the high-cost of the assays and devices used in nucleic acid testing," Mr Paul comments. On an average, the NAT can cost anywhere between Rs 5,000 to Rs 15,000, and can go up to Rs 25,000, given that only expensive hospitals in cities provide the facility. "The conventional methods are inferior compared to NAT. It takes longer time, and the results can be negative because of longer incubation periods. Certainly nucleic acid tests are very specific, faster, accurate and way of the future," Dr Fathima voices.   India's problem is that it has to import nucleic acids stains - mainly from the US or Germany. As a result, there is a payment of 40 to 50 percent import duty including transportation. Most nucleic acid stains are biohazards, toxic, carcinogenic, and mutagenic, and demands careful handling and disposal post experimentation. Nucleic acid stains are used on a daily basis in disease detection and DNA forensics, so disposing carcinogenic and hazardous substances is a major challenge. World's Safest Dye Right now, there are around 30 nucleic acid stains in the world that bind to DNA and RNA. They are widely used in DNA and RNA extraction, visualization and extensively in DNA Forensics, sequencing and genomic studies.   Azooka claims its fluorescent dye as the world's safest and fastest DNA and RNA stain. It was conceived out of Dr Fathima's PhD research, and was launched in March 2016, after 3 long years of hard work and research. "Our nucleic acid stain is purely an Indian product, and our customers can save big on import duties. Our stain is the first nucleic acid stain to be reported in India and APAC," adds Mr Paul. The stain is said to be the safest and fastest DNA stain available in the market. "Our dye is faster than the market leading stains like Ethidium Bromide which takes 10 to 40 minutes to stain. Our dye consumes only 30 seconds," Mr Paul points. The start-up is planning a worldwide product launch by the end of 2016. "Our commercial wing Bhoot Enterprises will fulfil the product manufacturing, distribution, marketing, and sales in India. There are some regulatory and IP challenges in taking our products to market, but we are working under the guidance of SID..." Mr Paul reveals. Comparing NAT and ELISA (Enzyme-Linked Immunosorbent Assay), a test that detects and measures antibodies in the blood, the latter's test timeline can vary anywhere between 3 to 6 months.   Azooka would focus on developing fluorescent dyes that can be used in multicolor labeling experiments such as FISH (Fluorescence in situ hybridization), FACS (fluorescence-activated cell sorting), chromosomal imaging, cell imaging, sequencing and other pharmacogenomics studies. "We are incubated for social impact, and we have a big mission. Our research is cutting-edge, but we didn't find the right market in India because molecular diagnostics is still nascent in the country. SID played an important role and recognized our innovation," she adds. Currently Azooka is seed funded and incubated at SID, IISc. The start-up operates only on research and innovation grants. "We want to purely be an IP- and R&D-based company by creating IPs and values. It is a big mistake to approach VCs immediately after conceiving your ideas. Once you discuss your ideas with VCs and if they are not convinced, you lose your ideas," he cautions. He emphasizes that once venture capitalists (VC) enter a start-up's picture, the focus of research changes. Mr Paul conceptualized most of the company's products, including the market research and the direction the start-up would take in the future. Prior to this, he was the director of product management and marketing at Zoho Corporation.   Chasing Challenges DNA-based diagnoses is not so popular in India unlike it is in the US, Europe or Australia. "Educating the market about what we do is a challenge. Finding the right talent is another daunting task," Mr Paul shares. Since India does not have proper molecular diagnostic system in place, many times HIV-infected blood, for example, were given to kids. In such circumstances, Azooka's dye is said to play a crucial role in detecting such diabolical elements in samples. Funding Dramas   Azooka's initial attempts to win grants proved tougher. "We were told to sell-off our technology and get settled for life. We were already running out of cash, and had a zero bank balance. But we didn't give up. We wanted to bring and build our innovative technology - the country's first nucleic acid stain -- right here in India," Dr Fathima states. While seeking funding, the start-up's final proposal was rejected by the committee since they claimed their technology as 'no novelty' status. "The committee is comprises of teachers and academicians who have very less knowledge about markets and entrepreneurship. Thus winning a grant is a challenge. The right system is not in place, and we had to pay a steep price," Mr Paul stresses. Azooka's products are targeted at blood banks, disease detection kit manufacturers, DNA-based diagnostic labs, DNA Forensics, academic institutions, universities, research labs, and companies in the pharmacogenomics space, seed companies in crop breeding and crop improvement, and medical device vendors.   "We are also looking forward for Patent Cooperation Treaty (PCT) to protect our molecule for 30 months all across the world in 160 countries," Mr Paul comments. At IISc, Azooka has over 20 customers already. "We want to first win the home ground before a global launch. We also want to partner with kit vendors and molecular diagnostics device manufacturers," Dr Fathima opines. The start-up expressed interest in working with Roche Diagnostics, Danaher Corporation, Thermo Fisher Scientific, Qiagen and Bio-Rad among others. Grants Worth Rs 200 Cr The Karnataka's Millennium Biotech Policy is seen as a fantastic initiative by the Government. Start-ups believe that if the policy is executed well, it will further elevate Bangalore to a greater position.   "About Rs 200 crore Government grants went unclaimed last year," reveals Mr Paul. "We need a one-window clearance system for start-ups. Currently there are no channels or ways through which entrepreneurs can know about availability of such fundings or accessing them. There is no proper communication between the Government and entrepreneurs to get those funds for research. There are fundings available in India and we want a place to go and look what is available. We want a portal where all the funding information is available. Applying for such funds are complicated. And most of them are archaic and old. Patenting and regulatory clearances seem expensive." In India, a mid-size DNA lab can cost up to $10 million. "...There is no proper ecosystem in the country in the area of application and the whole conducive ecosystem is missing. So all the great scientists go abroad, and also many companies hesitate to enter India," Mr Paul. In the West, entrepreneurs are seen to bootstrap and create value through their start-ups, or even just start off with uncertainties and slowly execute their strategy. "It is all about impacting billions and not putting billions into your bank account," Mr Paul mentions. Bare Ecosystem   He feels that the country does not even have websites to gain knowledge on trends happening in Biological Sciences. "The whole ecosystem is bare. We are following trends abroad. Personalization of medicine is creating a major trend globally. Gene banking is coming to India through Apollo Hospitals and Narayana Hrudayalaya where genes are going to be stored. We also do not have enough news and publications to know what is happening in our space and what companies are working on," he expresses. He says that in vitro diagnostic device (IVD) and in vivo imaging space is very nascent in India. "I wish a lot of start-ups would venture in to it. We need an ecosystem where reagents are made by ourselves which would bring down costs of research and diagnosis. We need to push the Government to make NAT mandatory. Most Life Sciences companies explore NGS or bigdata and are not product-based by creating IPs. IPs should stay within India rather than other countries trying to take it, like in the case of Turmeric and Neem," Mr Paul suggests. "Indian patent laws are stringent, and this is what is helping the country not lose its IPs and natural resources to other countries," notes Dr Fathima.   Biggest Lessons Mr Paul says that an entrepreneur needs tons of patience and perseverance in the journey. "Unlike IT, there are no alpha or beta versions of products in Life Sciences and medicine. Products need to be specific and stable," he advises. He advises start-ups to try their hands at funding methods like government grants which is valued at around Rs 800 crore. He also says that for Biotech start-ups, Bangalore is the best place to begin. Ahmedabad and Hyderabad are seen favorable for pharma start-ups. "A start-up is a small slice of the problem where an entrepreneur tries to solve it. Start-ups never die. They commit suicide. When people in a start-up stop caring about it, it eventually dies," says Mr Paul, quoting his ex-CEO Mr Sridhar Vembu of Zoho Corp.   As for Mr Paul, association with SID and IISc has a left a lasting impact on his career direction. "In a typical IT start-up, the pinnacle of success is seen as landing a job at Silicon Valley at companies like Microsoft, Google or Facebook or a unicorn start-up with billion dollar evaluations; or having millions of dollars in the bank; or even being featured on the cover page of popular magazines," he says.  He explains, "But my journey led me to meet scientists at IISc, who were solving the world's toughest problems like curing diseases or finding drugs and vaccines in India. A silent fight to make India a better place. They are the really happy people. They are humbled by the problems of the world, and try to help the humanity. Our families had a tough time comprehending what we were doing. "Being an expert in the IT services management, I even got a permanent residency to Australia. But we wanted to create a huge social impact in our homeland. People today will instantly judge you by looks. There is so much prejudice even before you hit the market. And Dr Fathima is a role model. There are women entrepreneurs struggling to make it in this space. But she made it despite challenges!" Being a woman, the journey had been quite uniquely challenging for Dr Fathima. "It takes a lot of courage because it isn't easy for a researcher to make a switch from being a scientist to an entrepreneur. Single-minded focus is also very important. You will encounter failures but every time you have to continue to move on no matter what. It is important to have passionate co-founders; to some extent you have to be selfless. For a Life Sciences start-up, it may at least take 5 years to get the product to the market," she elaborates.   "It has been challenging personally and professionally. Being a woman, the challenges doubled. The first best lesson I have learnt is to believe in myself. Believing in what I did. I believe that attitude will take you from where you are to where you want to go. Don't let your circumstances, family, or society pressurize you to lose that faith in yourself. That's the biggest battle I fought. I isolated myself from shame and insults and believed in what I did. "Once you lose faith in what you are doing then the purpose is lost. Associate with people who believe in you. For us, this is just the beginning of the journey. We have a lot to learn. It's a team work. My parents too gave me the liberty to do what I wanted to do. Never allow anyone to dictate your dreams," ends Dr Fathima gracefully. She is a mother of 2 kids and enjoys cooking and knitting. Wisdom Pills For Start-ups: â–ª Associating with right business partners, marketersâ–ª Expertise in chosen fieldâ–ª Finding good patent lawyersâ–ª Finding passionate team, right advisorsâ–ª Good fund managementâ–ª Regulatory awareness Myths To Debunk: â–ª Impossible to transition from IT to Life Sciencesâ–ª Product development takes 10-20 years ]]> https://biospectrumindia.com/news/97/1564/dbt-launched-indigenously-developed-stool-management-kit.html https://biospectrumindia.com/news/97/1564/dbt-launched-indigenously-developed-stool-management-kit.html Mon, 23 May 2016 11:28:15 +0530 Worldwide hundred million bedridden patients suffer from inadequate bowel management.Impaired bowel control and diarrhoea in bedridden patients pose significant challenges for patients and care providers alike. Patients with faecal incontinence and diarrhoea have 22 times higher odds of developing facility acquired pressure ulcers (FAPU), which increase to 37.5 times higher odds if they are also immobile. Traditional bowel mismanagement cannot even lead to an increased length of stay but also an increase in avoidable healthcare expenditure due to complications such as pressure ulcers and nosocomial infections Till date only few measures are available for management of faecal incontinence and diarrhoea includes absorbent pads and adult diapers. Though these methods are not so expensive, but obviously these methods are time consuming, labour intensive, and lead to costly complications, such as incontinence associated dermatitis (IAD), facility acquired pressure ulcers (FAPU), and spread of nosocomial infections. Indwelling balloon cuf-based faecal management systems have been shown to reduce risk of complications such as infection and skin breakdown. However, since these devices anchor on the pressure-sensitive anorectic junction, they put patients at risk of new complications, involving injury to the rectal mucosa and sphincter dysfunction. Qora is a closed-system stool management kit that hygienically contains liquid to semi-formed stool.It reduces the risk of complications associated with traditional bowel management. The kit minimizes nursing time and effort spent on stool management. It also optimizes safety and comfort for bedridden patients suffering from impaired bowel control.It has proprietary lattice diverter conforms to rectal wall at rest and during peristalsis, diverting faecal exudates while minimizing leakage.With this it has indwelling component designed to function in patients with all kinds of sphincter tone and without inhibiting normal anorectic physiology. Qora is innovative, patient-friendly applicator minimizes exposure to effluents and contaminants during device insertion. Device Components â—¾Hygienic Device Applicator: It comes preloaded with indwelling faecal diverter.â—¾Sampling, Irrigation & Withdrawal Port: For easier patient management during device use.â—¾Collection Bag: Detachable and disposable, hygienically collects stool and prevents odour.   A New Standard of CareIt reduces instances of facility acquired pressure ulcers and spread of nosocomial infections.It reduces burden on nursing staff, ensuring dignifies and compassionate patient care.It ensures better patient care , reduces length of stay and improved bed turnover Closed faecal management systems have been clinically shown to effectively prevent stool contact with skin, reducing chances of developing secondary complications that increase healthcare costs and extend the patient's length of stay. Switching to Qora not only brings down cost of consumables, but also decreases net overall cost burden of faecal containment. The intellectual property for the company's core Qora technology under DBT's ownership has been granted in key markets, including US, EU, Canada, Singapore, Australia, and Japan. As a result of its elegant and versatile design, the Qora technology has the potential to expand globally and benefit more than 100 million faecal incontinent patients each year.   ]]> https://biospectrumindia.com/news/97/7890/iscr-acknowledges-invaluable-role-of-patients-on-international-clinical-trials-day-.html https://biospectrumindia.com/news/97/7890/iscr-acknowledges-invaluable-role-of-patients-on-international-clinical-trials-day-.html Thu, 19 May 2016 16:56:02 +0530 Each year, May 20th is celebrated as International Clinical Trials Day to mark the day the world's first controlled clinical trial was conducted. India has 17 percent of the global population and 20 percent of the global disease burden yet India's share of all clinical studies being done in the world is less than 1.4 percent. Given that many of the regulatory challenges of the last two years have now been addressed through new amendments and orders, there is a need to rebuild the confidence of global and local stakeholders in order to strengthen clinical research in India. As the global community commemorates another International Clinical Trials Day on May 20th, the clinical research fraternity in India opines that regulatory challenges, misconceptions about clinical trials and lack of awareness amongst the general public are the most important factors holding back the progress of clinical research in India. The survey, which was conducted by pharmaceutical company Sanofi amongst attendees of the Annual Conference organised by the Indian Society for Clinical Research (ISCR) earlier this year, further identified the following as critical requirements:   • Improve the image of clinical research in the country by working closely with health authorities, organising patient awareness programs, strengthening collaborations with the media and introducing clinical research as a subject in pharmacy and medical college • Enhance the quality of trials conducted in India by strengthening the regulatory framework; increasing awareness among stakeholders including patients; accrediting investigators, sites and ethics committees; and increasing frequency of regulatory inspections. Many of these areas will be the focus as ISCR commemorates International Clinical Trials Day through various activities that will be held in the week of May 16th. Workshops and seminars with multi-stakeholders, panel discussion and deliberations with the regulators, training sessions and webinars are just some of the activities being conducted by ISCR Councils across the country. In addition, member organisations are hosting their own commemorative activities across locations which will include the screening of a public education film and a patient guide on clinical trials. This year, ISCR has decided to continue its focus on the theme of Patients First, to acknowledge patients who participate in clinical trials and contribute to finding new cures for so many diseases and to reiterate the clinical research fraternity's commitment to patients who wait in hope of better treatment and cure. Ms Suneela Thatte, President, ISCR says, "International Clinical Trials Day gives us an opportunity every year to highlight the invaluable role clinical research plays in helping millions of patients the world over get access to new and novel medical treatments and to thank those who have participated in clinical trials and helped in the discovery of life saving medicines and therapies. All stakeholders need to work together to rebuild confidence and trust amongst the global community in doing clinical research in India now that we have a more conducive regulatory environment in India for the conduct of clinical research." This year, ISCR reached out to create a wider sphere of engagement for patients to mark International Clinical Trials Day. The Society held a logo design contest for patients and asked them to send in entries that represented clinical research and its value to patients. The winner was Meryl Mammen, a 26-year old patient of Pompe Disease, a rare genetic disorder. The logo she has created will be used in all communication material for this year's International Clinical Trials Day. ISCR believes that while the value of clinical research in India is being appreciated more, its full potential has yet to be realized. ]]> https://biospectrumindia.com/news/97/7960/quadio-launches-the-first-ever-revolutionary-hearing-app-for-android-and-ios-in-india.html https://biospectrumindia.com/news/97/7960/quadio-launches-the-first-ever-revolutionary-hearing-app-for-android-and-ios-in-india.html Wed, 18 May 2016 13:15:26 +0530 Quadio Devices has introduced for the first time their path breaking Q+ hearing app in Mumbai on android and iOS platforms. The app promises to be a holistic mobile-based hearing solution complete with all the features of a conventional hearing tool. The Q+ app is a first of its kind free application that is ultra-advanced besides being affordable, accessible, controllable and customizable. Quadio uses the latest internet and mobile technology to push the boundaries of telemedicine and hearing care and merge the worlds of healthcare and technology. The Q+ app harnesses the processing power of your smart phone to enable it to be used as a complete and fully-functional hearing mechanism. It is designed to maximize the listening experience based on the results of a simple interactive hearing test. The app also gives you the ability to control and customize sound quality by intelligently enhancing hearing sounds and speech. With the Q+ app you can easily follow conversations using the phone headset in both quiet and noisy environments, and control the sound quality to customize it to your preference. The inbuilt hearing test in Q+ is calibrated for accuracy as per ANSI standards for audiometry. Sharing his excitement at the app launch, Mr Neeraj Dotel, CEO, Quadio Devices Pvt Ltd said, "Hearing loss is the second largest disability in the country that affects more than 120 million lives with majority sufferers over the age of 60. There are less than 2000 practicing audiologists in India and therefore most people have never actually received treatment until their hearing has degraded severely with age. The Q+ app is a stellar example of the innovative capabilities of Quadio where our customers don't have to shell out big bucks for hearing care and anyone with a smartphone can now have access to high-quality hearing mechanism."   Mr Anurag Sharma, co-founder and CTO Quadio Devices, said: "It gives me extreme pleasure to introduce Q+, a hearing solution app that delivers a complete hearing experience. When we started Quadio in 2009, the objective was to come up with a hearing solution that empowered people to hear what they wanted, how they wanted and wherever they wanted. The flexibility of controls offered by a smartphone app is much more than that offered by conventional hearing aids and, along with the affordability of smartphones, the reach of app store, and the inbuilt test, this gets us closer to achieving our objective. I appreciate the hard work put in by our team in creating a wonderful amalgam of technology, intuitive design and stellar performance into a package that is Q+." One of India's finest ENT specialists, Padma Shri awardee Dr Milind Kirtane, consultant ENT surgeon at Hinduja Hospital said, "I would say it would be ideal that universal new-born hearing screening be made compulsory or obligatory, because early detection and therefore early intervention, can really make a significant difference in the life of a person affected with hearing loss." Quadio was founded by two IIT graduates - Mr Paresh Patel from IIT Kanpur and Mr Anurag Sharma, a silver medalist from IIT Bombay with a vision to deliver innovative hearing solutions to anyone, anytime, anywhere, and empower individuals to hear what they want, how they want and when they want. Their mission is to increase penetration of hearing aids and solutions across the globe thus leading to improved quality of life for the hearing impaired.     ]]> https://biospectrumindia.com/views/97/6544/crisprcas9-a-new-hope-for-drug-discovery.html https://biospectrumindia.com/views/97/6544/crisprcas9-a-new-hope-for-drug-discovery.html Tue, 17 May 2016 12:30:12 +0530 The repurposing of a primitive adaptive immune response in bacteria, known as CRISPR (clustered regularly interspaced short palindromic repeat), has revolutionised gene editing and provides a new and powerful tool to interrogate gene function on a genome-wide level. Indeed, the contribution of this technology to drug discovery looks, from our current vantage point, to be substantial. The application CRISPR-Cas9 technology to whole genome screening is transforming our ability to perform target identification experiments and to understand complex biological processes, such as drug resistance. Thought to be devoid of the caveats associated with siRNA and shRNA reagents, the hope is that novel targets can be uncovered and rigorously validated using CRISPR-Cas9, and that a pipeline of innovative and validated targets will enter drug discovery programs. Indels are crucialCRISPR-Cas9 screens make use of short guide RNAs (sgRNAs) and Cas9 nuclease, two components of the CRISPR machinery in bacteria. The sgRNA, which Cas9 binds to, contains a protospacer adjacent motif (PAM) site and this enables the targeting of Cas9 to the RNA:DNA hybrid. Once bound, the Cas9 nuclease generates DNA double strand breaks precisely 3 base pairs away from the PAM site. These double strand breaks are repaired by non-homologous end joining (NHEJ), which frequently results in small nucleotide insertions and or deletions (indels) that can lead to the interruption of the normal reading frame, thereby disrupting gene function. Pooling resourcesUsing lentiviral transduction to deliver both the Cas9 nuclease and sgRNAs into cells, Horizon Discovery has adapted a pool-based screening protocol to examine the effect on cell survival of knocking out thousands of individual genes. The sgRNAs are designed to direct Cas9 to exons at the start of the open reading frame, such that any out-of-frame indels will result in gene disruption. The screen analysis is based on data from cells collected at the start of the screen (3-5 days after transduction) compared with cells collected at the end of a screen that have been exposed to a drug of interest, for example. The next generation sequencing (NGS) data from the initial time point acts as a comparator for the NGS data collected at the end of the screen, such that sgRNA loss and gain over the time of the screen can be established. We use a dedicated CRISPR-Cas9 screening analysis platform, adapted from the MAGeCK workflow (Li et al., 2014), which enables individual sgRNAs and gene hits to be ranked. Resistance discovery ahead of the clinicMany of the initial screens that Horizon Discovery has undertaken for a number of clients from the Pharmaceutical industry have examined mechanisms of drug sensitivity and resistance. Indeed, for our initial proof of concept studies we, like others, examined mechanisms of resistance to vemurafenib, a drug that targets the BRAFV600E activating mutation. The GeCKOv2 genome wide library, which contains 6 guide RNAs against 19,050 genes (Sanjana et al., 2014), was transduced into BRAFV600E mutant A375 melanoma cells and the cells were treated with vemurafenib. A comparison of the abundance of each guide RNA at the start and end of the screen was used to assess whether drop out or enrichment of guide RNAs had occurred over the course of the screen. 228 guides were shown to be >100-fold enriched, with several sgRNAs targeting the same genes. Using our analysis platform, the highest ranking targeted genes (MED12, NF1, CUL3, NF2, TADA2B and TADA1) were those whose loss is known to confer resistance. These findings repeated previously published data (Shalem et al., 2013, Huang et al., 2012, Whittaker et al., 2013). Interestingly, when the sgRNAs for each of these hits were evaluated individually, it was clear that not all guides performed equally well in the screen. This emphasises that for successful screening, the library composition and complexity are key considerations. Increasing the odds with a haploid approachEngineered from KBM7 fibroblasts, eHAP cells are a fully haploid cell line and are particularly suited to CRISPR-Cas9 screens because there is only one copy of any given gene to edit. We used the eHAP cells to examine the mechanisms of resistance to 6-thioguanine (6-TG), a purine antimetabolite that is used in the treatment of leukaemia. The biology of the DNA mismatch repair (MMR) system and factors that mediate resistance to 6-TG have been extensively studied and as such provide an excellent paradigm to test the power of CRISPR-Cas9 resistance screens in haploid cells. eHAP cells were infected with the whole genome GeCKOv2 library and were exposed to either 500nM 6-TG or vehicle control and maintained in culture to allow sgRNA enrichment and depletion to occur. As expected, NGS analysis revealed that sgRNAs targeting MLH1, MSH2 and MSH6, three genes that encode MMR proteins, were enriched in the screen (Branch et al., 1993; de Wind et al., 1995, Abuin et al., 2000, Buermeyer et al., 1999). To validate these targets as 6-TG resistance factors, MLH1 and MSH6 knockout HAP1 cells were generated using a CRISPR-Cas9 approach. These cells were able to proliferate in the presence of 6-TG unlike the parental cell line. Thus, CRISPR-Cas9 approaches were used to both identify the mechanisms of resistance and to validate them.   The future looks brightCRISPR-Cas9 is a fast moving technology that has been embraced across the board. As discussed above, it has been used to successfully identify mechanisms of drug resistance in whole genome screens, but its applications extend further into animal model generation and genetic therapies. Its use, particularly in humans, is the subject of much debate that looks set to continue for years to come. However, in terms of drug discovery, CRISPR-Cas9 technologies look poised to replace RNAi as a new avenue for more effective drug discovery. Thanks to NGS, we are starting to catalogue the plethora of mutational changes that occur in the genome of any cancer cell. With this knowledge comes potential - novel mutated genes and the proteins that they encode, are candidates for prognostic markers and/or new drug targets. With the ability to rapidly engineer cells (and animal models) using CRISPR-Cas9 technologies, the generation of robust models needed for improved target identification and validation promise to be attainable.   ]]> https://biospectrumindia.com/views/97/3435/crispr-cas9-genome-editingleading-in-engineering-inspiring-design-and-empowering-discovery.html https://biospectrumindia.com/views/97/3435/crispr-cas9-genome-editingleading-in-engineering-inspiring-design-and-empowering-discovery.html Tue, 17 May 2016 12:29:50 +0530 With increasing expansion into research areas of more biological relevance, existing molecular and cellular techniques need to be improved. The area of genome editing is rapidly growing and requires more advanced techniques to maximize its potential applications. Transcriptional activator-like effector nucleases (TALENs) and technology derived from clustered regularly interspaced short palindromic repeats (CRISPRs) allow precise cleavage of DNA at specific loci. However, the effectiveness of these tools is contingent upon the intrinsic properties of the locus of interest, efficient delivery, and the painstaking downstream processes of generating stable cell lines and knockout models to study the phenotypic effects of such genetic modifications. CRISPRs and CRISPR-associated (Cas) proteins are found in many bacteria and most archaea. The CRISPR-Cas systems use sequences derived from plasmids and phages to activate Cas endonucleases to neutralize those plasmids and phages via RNA-guided sequence-specific DNA cleavage, thus blocking their transmission and creating a simple acquired immunity. With their highly flexible but specific targeting, CRISPR-Cas systems can be manipulated and redirected to become powerful tools for genome editing. CRISPR-Cas technology permits targeted gene cleavage and gene editing in a variety of eukaryotic cells, and because the endonuclease cleavage specificity in CRISPR-Cas systems is guided by RNA sequences, editing can be directed to virtually any genomic locus by engineering the guide RNA sequence and delivering it along with the Cas endonuclease to a target cell. Thermo Fisher Scientific provides an easy-to-use, optimized and validated genome editing solution, designed to expedite life science research. The Thermo Fisher Scientific solution spans the entire cell engineering workflow, making genome editing accessible to anyone at any level. And Thermo Fisher will continue to expand its suite of genome editing products, from cell culture and delivery reagents and sample preparation, to genome modification, detection and analysis of known genetic variants. An online CRISPR search and design tool along with CRISPR-Cas9 is available to researchers in four formats: an all-in-one expression vector, Cas9 mRNA, Cas9 protein, and CRISPR libraries services. These gene editing solutions are paired with the optimal cell culture reagents, delivery method, and analysis tools based on required application and cell type.   CRISPR Search & Design tool allows scientists to search a database of >600,000 predesigned CRISPR gRNAs in human and mouse genes or analyze their sequence of interest for de novo gRNA designs using algorithms. The tool is designed to analyze genes of interest, identify gRNA sequences adjacent to protospacer adjacent motif (PAM) sites, and rank order resulting gRNAs based on potential off-target effects. Up to 25 gRNA sequences per gene are provided with recommendations based on potential off-target effects for each CRISPR sequence. Researchers may improve the cleavage efficiency up to 85 percent by pairing Cas9 Nuclease and Transfection Reagent. Cas9 protein and guide RNA (gRNA) form a very stable ribonucleoprotein (RNP) complex that provides the next level of cleavage efficiency over CRISPR-Cas9 vector and mRNA-based systems when paired with Transfection Reagent. The Cas9 RNP complex can act immediately after it enters the cell, since transcription and translation are not required. Moreover, the complex is rapidly cleared from the cell, minimizing the chance for off-target cleavage events when compared to vector-based systems while eliminating time-consuming cloning steps. Transfection reagent for CRISPR-Cas9 protein delivery provides the cleavage efficiency of electroporation with the simplicity and scalability of a reagent. It is an ideal alternative to electroporation as it is gentler on cells and more cost effective overall features and benefits include: Low cell toxicity- fewer cells needed to initiate your experiment Cost savings-including both cost-per-reaction and initial investmentEasy scalability-an ideal delivery solution for high-throughput experiments Advances in genome modulation and editing have the potential to change the way we create energy, produce food, optimize industrial processing, and detect, prevent and cure diseases-improving the human condition and the world around us. Thermo Fisher's trusted products harness the power of science to transform lives. Its instruments, routine tools and services offer high-quality, innovative life science solutions for every lab.   ]]> https://biospectrumindia.com/news/97/6981/mapmygenome-launches-babymap-carrier-newborn-screening-.html https://biospectrumindia.com/news/97/6981/mapmygenome-launches-babymap-carrier-newborn-screening-.html Mon, 16 May 2016 15:27:12 +0530 Recommended for newborns, expecting parents, and people planning a pregnancy, this test screens for 71+ metabolic conditions that can be treated in newborns. Ms Anu Acharya, CEO of Mapmygenome announced this news, adding, "Pregnancy and parenthood are among the most joyful experiences in a person's life. We want to make these experiences healthy and tension-free. Babymap allows parents to make informed choices to ensure their newborns and future children stay healthy." Dr Radha Rama Devi, MD (Peds) at Rainbow Hospital who was instrumental in setting up the first Newborn Screening for preventable causes of mental retardation in India and published the first data on the prevalence of these disorders in the Indian population, said, " Babymap is an excellent idea and will replace the newborn screening tests currently used". Babymap test requires blood samples for genetic testing using the technology platform Next Generation Sequencing for over 31,000 pathogenic single nucleotide variants and minor insertions and deletions. Following analysis, a session with Mapmygenome's genetic counsellors allows parents to learn about their carrier status and future course of action. This test starts at Rs 30,000 for individuals, with attractive pricing options for couples and parents of newborns. Mapmygenome plans to market this test through their healthcare partners.   ]]> https://biospectrumindia.com/views/97/7723/single-use-micro-scale-bioreactor-enables-higher-productivity.html https://biospectrumindia.com/views/97/7723/single-use-micro-scale-bioreactor-enables-higher-productivity.html Fri, 13 May 2016 10:32:50 +0530 Worldwide sales of biologic drugs including monoclonal antibodies (mAbs), fusion proteins and therapeutic enzymes now exceeds $120 billion per year. These therapies cost more than small molecules, in part because they are more expensive to manufacture. A strategy for reducing manufacturing COGs (cost of goods) is to use advanced automated micro and mini bioreactor models to improve upstream cell culture productivity by selecting better clones and enabling more efficient optimisation of media, feed and culture conditions. Traditionally, cell culture development for bioprocessing begins with screening to find clones that express the most protein. This is usually performed in small volumes of 0.1mL to 6mL using a multiwell plate format. Because of the need to conduct large numbers of experiments this has resulted in the development of systems based on 24 well single-use multiwell plate. These have the advantage of being quick and easy to set up and use and because the multiwell plate are pre-sterilised there is no pre-process preparation and as they are single-use there is no post-run cleaning. Some of these multiwell plate systems do provide monitoring and some control of dissolved oxygen (DO) and pH but have the drawback that they do not mimic the sparging or stirring action of a large scale bioreactor as they rely on shaking for mixing. Additionally, they do not provide automated feeding and have a working volume of less than 6mL, which limits the amount of analytical testing possible. Clone selection and early process development to identify the most productive clones and define optimal media or culture conditions is typically performed in shake flasks with two or three top clones carried forward for evaluation in bench top bioreactors. Using shake flasks and bench top bioreactors is very labour intensive and as they are generally made of glass, require time consuming pre and post-process cleaning and sterilisation for every experimental run. Shake flasks provide no active control of pH and DO, relying on the buffering capacity of the media and the gas environment of the incubator. The mixing environment is unlike that in a bioreactor as there is no impeller. Additionally, shake flasks are often manipulated by hand, making it difficult to perform nutrient feeding or sampling without introducing variability. Hence, the use of shake flasks can often result in different cell growth and titre profiles to those seen after scale-up in a bioreactor. Data published in Cytology of a study at Genentech demonstrates that when cultured in shake flasks, Chinese Hamster Ovary (CHO) clones expressing mAbs do not show comparable culture performance with those grown in 2L bench top bioreactors. Using bench top bioreactors does mimic the sparging and stirring action of a large scale bioreactor but they require considerable amounts of time for set-up, operation and post-experimental cleaning and sterilisation. Therefore, the amount of available resource often limits use of bench top bioreactors requiring that researchers have to select only their top clones to test in this way. This can lead to the final choice of clone sometimes performing sub-optimally upon scale-up, adversely affecting yield and titre. If a larger number of runs could be performed during clone selection under conditions which are representative of the scale-up bioreactor environment, then it should be possible to isolate a better performing clone for use in manufacturing and potentially save thousands of dollars in manufacturing COGs.   To meet the need for a single-use bioreactor model that provides comparable mixing, gassing and sampling parameters to be used in place of shake flasks and bench top bioreactors, the advanced micro and mini scale bioreactor systems, ambr15 and ambr250 (Sartorius-Stedim Biotech) have been developed. These integrated systems combine 10-15mL or 100-250mL single-use bioreactor, with an automated liquid handling workstation and dedicated control and analysis software. Critical to the use of these systems as bioreactor models is the geometric similarity to larger bioreactors and that their contents are stirred by an impeller and gases can be supplied by sparging. In addition, the software control systems and integrated single use sensors enable these systems to control the culture conditions in a similar way to large scale systems ensuring scalability. Each workstation maintains aseptic conditions using a HEPPA filtered environment (ambr 15 can be installed in a standard biological safety cabinet and the ambr 250 includes an integrated system) and provides independent parallel control of either 12 or 24 (ambr 250), 24 or 48 (ambr 15) bioreactors. The workstation controls the stir speed, gas supply and temperature and also provides liquid handling automation functions for the bioreactors, each of which can have its own medium, feed, inoculum and sampling strategy. Each bioreactor also incorporates sensors for real-time measurement and bioreactor-specific automated control of DO and pH and set points. A major contract research organisation (CRO) compared the timelines for clone selection and early process development of a mAb expressing (CHO) clone using shake flasks and bench top bioreactors with the automated micro bioreactor. The results showed that with reusable shake flasks and bench top bioreactors, clone selection and early process development took around 22 weeks, whereas using the single-use micro bioreactors and a confirmatory run in a reusable bench top bioreactor this was reduced to six weeks. Single-use micro and mini bioreactor technology can provide an accurate prediction of cell growth and protein titre achieved in bench top bioreactors. Setting up and running reusable shake flasks and bench top bioreactors is manually intensive, while the fully automated single-use micro and mini bioreactor is more convenient, taking much less time to set-up and run, as well as requiring no time consuming post run cleaning and sterilizing. Thus clone selection and early process development can be performed rapidly and efficiently, increasing the number of clones that can be evaluated by up to ten fold. This improves the chances of selecting a clone with optimal growth and protein expression. The automated system makes it easy to implement DoE into the work flow and the geometric similarity of the platforms reduces the risks for scale-up to larger single-use pilot and manufacturing scale stirred bioreactors, reducing time-lines and saving cost. Author   ]]> https://biospectrumindia.com/views/97/8321/exploring-new-frontiers-in-biological-science-using-mass-spectrometry.html https://biospectrumindia.com/views/97/8321/exploring-new-frontiers-in-biological-science-using-mass-spectrometry.html Fri, 13 May 2016 10:32:18 +0530 Innovation is shrinking industrial machines and medical devices to the scale of atoms and molecules. Mass spectrometry is one of the important and versatile tools that will drive the future of bio-science through its potential utility in R&D where pharmaceutical industries increase investment to achieve discovery of novel compounds. This technology will continue to drive high-throughput screening of candidate molecules together with advances in "omics" technologies (genomics, transcriptomics, proteomics, metabolomics) and biomarker identification. Mass Spectrometry is used in industrial and academic fields for both routine and research purposes. Today, there is no single area of experimental science where mass spectroscopy is not being used. It is used to understand the fundamental atomic and molecular processes and, at the same time, those of immediate relevance to events within cells. As a technique, it helps to control processes in chemical and biological industries, diagnose diseases, discover new drugs, protect the environment and explore mysteries of nature. Scientists and biologists face many challenges in functional biology studies that require the observation of proteomes over many time points, precise spatial distribution of proteins and different cellular states. These issues translated into the analytical challenge of performing reproducible and precise quantification of a few selected biological components in the presence of very complex background.One of the major challenges in proteomics is the quantification of low abundance proteins and peptides of biological relevance such as transcription factors or low stoichiometry post translational modified proteins. The quantification of these analytes of interest is complicated by the very large dynamic range observed for cellular protein expression, especially in humans. With the development of new generations of mass spectrometry platforms providing high resolution and multiple detector versatility, new strategies are available to push the limits of quantification. This new technology ensures that scientists don't miss anything in their area of research and provides a strong platform, combining next-generation screening techniques with advanced targeted methods for protein quantitation. It is designed to expand researchers' capabilities in advanced proteomics and metabolomics applications, including targeted, data-independent acquisition (DIA) and top-down analyses with the industry's highest level of sensitivity. This delivers more complete sequence coverage and allows scientists to perform more inclusive analyses. On January 27, 2016, Thermo Fisher Scientific's Orbitrap Fusion Lumos Tribrid Mass Spectrometer received the SelectScience Scientists' Choice Award for Best New Drug Discovery Product of 2015. This award celebrates the new technologies that made the biggest impact in drug discovery and development research in 2015. The awards are unique in this industry as they empower scientists to nominate and vote for their favorite new product, allowing them to have their say about which manufacturers have truly enabled their work.We're seeing firsthand how Orbitrap mass spectrometry is driving the future of bioscience, helping scientists push the limits of quantitation and protein characterization further and faster. It is ideal for laboratories that require more extensive and more profound analytical information from their sample, especially lower limits of detection and better sequence coverage when characterizing proteoforms, which was not possible with other high-resolution mass spectrometry systems. This technology also enables scientists to:• Confidently quantify low-level analytes, low atomic LOQ in nLC analysis and fg in high flow analysis;• Be more selective about which instruments they perform their MS/MS experiments on;• Characterize intact proteins with top down on LC time scale, which means lower detection limits and higher throughput; and• Elucidate structures more thoroughly and easily by using any fragmentation mode, at any stage of MSn analysis, with detection by either analyzer, which maximizes structural information from metabolites, glycans, PTMs, and sequence polymorphisms.       ]]> https://biospectrumindia.com/views/97/8102/triumph-of-high-precision-parallel-bioreactors-over-conventional-systems-in-process-monitoring-and-optimization.html https://biospectrumindia.com/views/97/8102/triumph-of-high-precision-parallel-bioreactors-over-conventional-systems-in-process-monitoring-and-optimization.html Fri, 13 May 2016 10:31:44 +0530 The Biopharma industry is growing steadily at a significant pace and so are their investments in research and development. Investment in biologics like vaccine, biosimilars, novel biopharmaceuticals, cell and gene based therapeutic products are seeing a never before trend. The stakeholders, both scientists and investors are looking forward to shorter timeframes in getting the results and the product of interest launched in the market respectively. As these processes involve cell culture or microbial fermentation, the need for dedicated mini-bioreactor systems for process development and critical parameter optimizations in low volume ranges are certainly creating interest compared to the conventional fermenters and bioreactors. With time being very critical, the single use vessels are also gaining more attention over autoclavable formats among the Biopharma users. From Conventional shake flasks to Parallel Bioreactors: While initial bioprocess development involving microbial or cell culture involves several steps like cell line optimization, clone selection, screening for media and feed components along with other process conditions, conventional Shake flasks are still used for optimizing these early steps. Though widely used, Shake flask formats only allow identifying temperature, ambient gas mix and agitation rates but pose limitation upon reaching scalable levels with respect to the industry standard monitoring and control requirements. Critical process parameters like pH, dissolved oxygen (DO), gas flow rates and feed schedules of media components are beyond the capabilities of shake flask format. Moreover equipment used for screening or optimization in the earlier steps should mimic the physical and mechanical characteristics of production-scale reactors to the greatest degree possible, to ensure consistency throughout development phases. The parallel bioreactor system provides all essential features in a compact and comprehensive design with flexibility to optimize and understand parameters that influence growth kinetics, productivity, product quality and stability. Parallel bioreactors over the Micro / Mini bioreactor systems: Though micro and mini bioreactor systems address the basic needs of media selection and optimizations they still do not support when it comes to scalable proportions and concerns over unconventional formats are not uncommon. Lower volume by itself seems to limit for applications where the processes requirements are not flexible. Feed rates, sampling volumes to mention a few could be mandatory in these critical steps of characterization or optimization. Hence selection of an ideal system for lower volumes is no different from the standard volumes when it comes to the expectations of the process outcome.   Expectations in a parallel bioreactor system: With more manufacturers getting in to this space the expectations also grow high from the user end. Hence the demand for compact, comprehensive and flexible system to adapt to present and future needs is on the cards. While deciding the number of vessels the primary requirement starts with a compact and less space occupying system. But when coming to the process needs features like flexibility for upgrades to enhance or extend the configuration to meet evolving needs, minimum level of scalability in working volumes to establish proof of concepts, possibility for seamless integration to downstream equipment are certainly the priorities. Above all a simple and user friendly Supervisory control and data acquisition (SCADA) software convenient for data acquisition, monitoring and processing becomes mandatory. DASGIP Parallel Bioreactors from Eppendorf: DASGIP parallel bioreactor systems for Microbial or Cell Culture applications from Eppendorf combine the advantages of small working volumes with the full functionality of industrial bioreactors. The modular design allows expanding the system capabilities in 4,8,12 or 16 parallel vessels format controlled by single operating system. The vessels are the industry standard stirred tank reactors with different workings volumes ranging from 60 mL to 3.8 L. The modular system provides the flexibility to configure to the needs of user with respect to number of pumps, gases and their flow rates. The availability of single use vessels of different volumes have provided users the flexibility to choose between autoclavable and single use vessels in both microbial and cell culture applications. DASBOX parallel mini bioreactor system for microbial or cell culture has the option to use a dedicated vessel volume with working volume ranging from 60-250 mL. These systems are also designed to operate in modules of 4, 8, 12 or more vessels. With both autoclavable and single use vessel formats available, the user has the choice to select. Availability of Photosynthetic light module can make it a convenient choice for users working either with plant cells or for Biofuel. Both DASGIP and DASBOX systems can be calibrated in parallel for pumps and sensors making the vessels perform as replicates. Though designed for parallel reactions, these can also be controlled independently for maintaining completely different parameters. DASGIP control software allows parallel monitoring, data capture with online analysis options. Combined with other software options, the system can be integrated with third party equipment like metabolite analyzer, Raman spectrometer etc. The DASware software platform provides larger integration and analysis flexibilities like Design of Experiment (DoE), remote monitoring and controlling, communicating with third party OPC compliant systems and more. Along with the New Brunswick Fermenters and Bioreactors to complement from the Eppendorf Bioprocess portfolio, the scale up process can be continued from parallel process through bench, pilot and production levels.     ]]> https://biospectrumindia.com/news/97/3332/who-address-worsening-urban-air-quality-as-a-priority.html https://biospectrumindia.com/news/97/3332/who-address-worsening-urban-air-quality-as-a-priority.html Thu, 12 May 2016 17:18:21 +0530 Improving air quality must be a top health and development priority in countries of WHO South-East Asia Region as increasing air pollution levels are putting the health of billions of people at risk, said Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia, in a WHO press release. She added, "More and more cities are now measuring air quality levels, which in itself is an indication that governments are recognizing air pollution as a problem. Monitoring air quality is a critical step for taking corrective action. Nine of the 11 countries in the Region have accessible data on air quality in the global report, with India having data from 122 cities." There is an overwhelming evidence of the impact of air pollution on stroke, heart disease, lung cancer, and chronic and acute respiratory diseases. Globally, in 2012 air pollution in urban areas is estimated to have caused 3.7 million deaths with more than one-third reported from the South-East Asia Region. Though awareness is rising, there is an urgent need to address the problem and implement evidence-based interventions.   Transportation, power plants, biomass burning and ambient dust are major contributors to particulate air pollution. "In an urban setting, vehicular emissions are an important consideration, particularly with populations living in close proximity to roads. The problem of air pollution can only be addressed through multi-sectoral cooperation. Increasing use of clean energy such as LPG, renewable power sources like solar and wind, and prioritizing public transportation, walking and cycling amenities in cities are among a number of affordable strategies that can be adopted," opined Dr Poonam. The energy, transport, environmental and health sectors need to intensify their work together to prevent further impact, she held. WHO also said in a press release that it is committed to enhancing the global response to adverse health effects of air pollution with a coordinated set of actions at global, regional, national and city levels to change the trajectory of adverse effects of air pollution on health. ]]> https://biospectrumindia.com/views/97/7284/separating-beyond-question-acquity-qda.html https://biospectrumindia.com/views/97/7284/separating-beyond-question-acquity-qda.html Thu, 12 May 2016 11:31:25 +0530 When Albert Einstein forged the bedrock theory of modern physics 100 years ago, he had no computer, no internet and few homes had telephones. Yet it took one of the most sophisticated science tools ever built, at a cost of hundreds of millions of dollars, to prove an idea the scientist had crafted with little more than paper, a fountain pen, hard work and a mind sharper than most. Recently physicists announced they had detected gravitational waves, hitherto a key unproven element of Einstein's general theory of relativity. It is not always the complicated process work better but simple tools and process are faster and accurate too. Waters also with same philosophy started searching for simple answers for complicated questions. One of the Complicated process in analytical industry was handling of Mass detection technologies. The research is still on, to find the most sensitive Mass spectrometer or detector. Waters thought differently and focussed on simplifying the usage of the Mass detector technology so that it reaches to masses and today we have world's smallest, sensitive enough , very robust, and highly user friendly Mass detector- Acquity QDa. The product is a truly a industry changing technology. The idea was to empower and enable chromatographers with accessible mass data, without the training, without the complexity, without extensive compound-specific optimisation. This is realised through the Acquity QDa detector which is now revolutionising practices within laboratories in India and globally. Within India we have more than 20 companies using the technology in different areas of R&D, Quality Control, Drug Discovery etc. The vision of the Acquity QDa was born through the unmet need of the analytical scientists. Today many prestigious scientists and multi-national companies are thrilled with its impact on quality of data. The QDa has been recognised throughout the industry both India and globally garnering very positive reviews and winning multiple awards for innovation. Acquity QDa was listed as one of the top 15 innovative products of the year. Increased efficiency is coming from dramatic innovation. The result of over 30 patented Waters innovations, this the only mass detector that fits on top of your instrument stack. Using less bench space and less energy than a traditional mass spectrometer, it fits easily within your existing lab set up as part of your regular workflow. Even most cleaning and routine maintenance have been innovated away, maximizing your uptime. This is fundamentally different from any experience one would have had with MS.   In any analytical development we majorly rely on UV/PDA detector as detector of choice and live with the limitations of same. To have more confidence in data, to understand the development process better and to resolve the complex cases of mass balance we need to have orthogonal analytical detectors like Acquity® QDa in our development process. The usage of the detector ensures confidence in the data and hence "Right time- first time". The challenges in UV/PDA based developments can be resolved using this orthogonal detector Acquity QDa Mass Detector, which have been purposefully designed to enable analysts to readily incorporate mass detection within a UV/PDA chromatographic workflow. The simplicity of this Single Quadrapole Mass detector is such that it can be handled easily by the chromatographers who have no MS trainings and are only UV/PDA users. Acquity QDa has the quickest start time, once switched on, the detector is ready to use in less than 25 minutes. Acquity QDa through Empower CDS software can enable scientists to do tasks like peak tracking, identify impurities/peaks, analyze non-chromophoric impurities, understand mass-balance related issues, perform MS finger printing, confirm peak purity data, etc. With recent interest of many organizations in Biologics and Biopharmaceuticals, Acquity QDa has emerged to be quite useful in these areas as well. Acquity QDa enables greater selectivity, faster - high throughput methods, and mass confirmation for greater certainty and productivity in routine "Glycan monitoring". Acquity QDa is being utilized by many organizations to monitor peptides over a wide molecular weight range. The addition of mass detection allowed scientists to monitor and quantify peptides with greater specificity. Acquity QDa expands the sensitivity currently available with optical only workflows. The addition of Acquity QDa to existing workflows allows scientists to selectively detect and monitor co elution species. And perhaps most importantly, Acquity QDa works with both TFA and FA based separations. Recent publications like "HILIC-MS Determination of Genotoxic Impurity of 2-Chloro-N-(2-Chloroethyl)Ethanamine in the Vortioxetine Manufacturing Process" by Zentiva (Sanofi), "Implemenation of a single quad MS detector in high-throughput transdermal research of plant extracts" by University of Ghent and " A novel compact mass detection tool for the open access (OA) environment in drug discovery and early development" by Merck use Acquity QDa technology and hence exhibiting the potential of this simple and powerful tool. ]]> https://biospectrumindia.com/views/97/5079/are-you-ready-for-laboratory-transformation.html https://biospectrumindia.com/views/97/5079/are-you-ready-for-laboratory-transformation.html Thu, 12 May 2016 11:30:43 +0530 Rising populations in emerging economies will lead to increased demand for medical devices, diagnostic equipment and pharmaceuticals in the near future. At the same time, this demand will leverage technological advances. In vitro diagnostics (IVD) is one such industry that is witnessing proliferation of technology in terms of new assays, workflow excellence, turn-around time, etc. IVD plays an integral role in healthcare & disease management. The influence of diagnostic tests on clinical decisions is very high - almost 75% of clinical decisions are based on a diagnostic test. The global in vitro diagnostics market is estimated to reach $75.1 billion by 2020, growing at a CAGR of 5.8%1. The Indian IVD industry, still in the inception stage is valued at more than $500 Million and is expected to surpass $1.5 Billion by 20182. Growth Drivers for IVD Demographic ChangeWith a population of more than 1 billion, India is world's second largest country and therefore a significant market to the healthcare providers. The demographic change has led to growth in tier || and ||| cities creating disposable income ultimately leading to a change in lifestyle patterns and an increase in the lifestyle diseases like cardiovascular diseases, lung disease, cancer, obesity, diabetes, etc. One in four Indians is at a risk of non-communicable lifestyle disease3. Accurate and quick diagnosis of diseases has thus become a crucial factor in providing quality patient care.   Turn-around Time (TAT)The diagnostics labs operate in a dynamic environment. In addition to the accurate diagnosis, reduced turn-around time (TAT), consistent delivery and affordability have become the need of the hour. Turn-around time is the most noteworthy manifestation of laboratory service and a crucial barometer of laboratory performance. As a result, laboratories of all sizes are adapting total automation across pre-analytical, analytical and post-analytical processes integrated with information technology (IT) since information systems are a key differentiator among major healthcare providers. Technological InnovationsThe innovations and discoveries in the IVD market are transforming the healthcare arena. The IVD market includes a variety of advanced and cutting edge technologies to project the disease state, choose the right treatment and monitor the patients response to the treatment. An array of assay caters to wide spectrum of diseases. Automation, a unified solution developed expressly for the changing workload and expanding needs of today's clinical laboratory is playing a key role in the entire diagnostics set up. It provides unlimited potential for lab optimization by combining peak performance, adaptability, and intelligent technology. However, the challenges of implementing lab automation can be formidable. It is a complex undertaking to meet business objectives and clinical requirements while managing logistics, timelines, people and technology to achieve workflow excellence. And the operations must continue uninterrupted during this transition! The work in any laboratory is typically broken in three phases. 1. The pre-analytical phase: this comprises of patient sample identification, test request registration and billing, sample collection, labeling by barcode, separation followed by transport and sample processing.2. The analytical phase: this comprises of properly calibrating the instruments, the quality control process and analysis of samples.3. The post-analytical phase: This includes all the processes that follow the testing of the samples. Namely, the validation of test results, transcription of results into the records, printing and dispatch of the results. Also, the data so generated needs to be stored. The samples also need to be stored for specified period of time for repeats or add-ons. With this background, it is critical for laboratories to optimize the following flow across these three phases.• The Sample flow has to do with the collection of the samples, to sorting, transportation until their disposal and/or they are sent out.• The Data (Information) flow goes from order entry to receiving or accessing, quality control, etc. all the way to validation, reporting and billing.• The Material flow includes inventory tracking; invoicing and payment etc. Removal of non value-added steps such as reducing sample touch points, manual bench sorting aliquoting & transportation, sample rerun, results review is a key to achieving workflow excellence. Automation - the way ahead !Statistics indicate that there has been an approximately 25 percent increase in laboratory tests due to screening and follow up for lipid profile, blood glucose levels, glycosylated haemoglobin, speciality tests for thyroid hormone levels, vitamin levels, infectious serology and basic cancer markers(4,5)The diagnostics and pathological lab test market has the potential to grow at a CAGR of 18.9 percent(4,5) With Automation, labs of all sizes can transform their operations to harness change and drive maximum performance and efficiency. Laboratories can also customize their automation solutions by identifying the sustainable workflows. Labs can consolidate multidiscipline testing into a single, fully automated solution or improve spatial efficiency, tube utilization, or resource allocation. Siemens has helped diagnostic laboratories leverage the benefits of automation and information technology since 1998-making workflow more efficient and flexible while improving turnaround times, reducing errors, and cutting costs. Laboratory Automation allows for a broader diagnostic scope and increased accuracy. Ultimately, laboratories will be able to perform more tests in-house and reduce their dependency on outsourcing services in addition to the decrease in number of duplicative laboratory process and increase in throughput.This will also allow staff to be better utilized beyond bench testing and routine operation including but not limited to patient interaction, finance, marketing services and strategic planning.   ]]> https://biospectrumindia.com/news/97/8160/sun-pharma-leverages-mobile-technology-to-boost-treatment-compliance-amongst-asthma-patients.html https://biospectrumindia.com/news/97/8160/sun-pharma-leverages-mobile-technology-to-boost-treatment-compliance-amongst-asthma-patients.html Tue, 10 May 2016 11:36:07 +0530 As part of its focus to give boost to treatment compliance amongst Asthma patients by minimizing instances of non-adherence and drop-outs in Asthma treatment regime, Sun Pharma is rolling out India's first unique & innovative mobile application that will connect Doctors and Asthma patients. This App has been specifically developed by Sun Pharma for enabling doctors to track treatment progress of their patients and increase compliance to medication for better management of asthma disease. It is estimated that nearly 50 to 70 percent patients in India do not adhere to asthma treatment regimen recommended by a doctor. Up to 50 percent of such non-adherence is on account of the patient's forgetfulness to take medicines on time and due to inadequate understanding of the prescribed treatment regimen. Sun Pharma's RespiTrack aims to address these and other reasons leading to non-adherence thereby improving compliance to Asthma treatment through recurring medication reminders, pre-programmed alerts, Over-the-Air review by the doctor etc. Commenting on its RespiTrack mobile Application, Mr Abhay Gandhi, CEO - India Business, Sun Pharma said, "Unlike other chronic illnesses where non-adherence to treatment regimen could have significant impact on the patient's health, Asthmatics tend to be low on the short-run adversity impact of non-adherence. However, in the long run, the implications of non-adherence to prescribed Asthma treatment can severely impede quality of life of these patients. By leveraging our digital technology capabilities, we believe RespiTrack can address this unmet need by reducing non-adherences incidences to treatment." For an Asthma patient, RespiTrack allows complete monitoring of asthma attacks, symptoms and medications prescribed by the physician. It enables these patients to record time, place, duration & triggers of attacks along with medication details on the mobile App. The patient can easily send this data to the consulting physician through over-the-air mode on a weekly or monthly basis. RespiTrack also offers a review dashboard that gives a snapshot of all parameters to monitor over a period of time.   Through RespiTrack, a doctor can access his patient's details through a personalized tracker module which is directly synced with the patient's App. This module allows doctors to access patient's ailment history, attack patterns, symptoms, medication patterns and reports. A doctor can remotely view patient reports and also connect with them through an integrated messaging app. As per WHO Report, India has an estimated 15-20 million asthmatic patients. Various studies estimate that nearly 40% of Asthma patients use inhalers and the rest prefer oral formulations. Sun Pharma's RespiTrack is available on Google Play Store & Apple Store. A patient needs a Registration Number issued by his/her doctor to use this App.   ]]> https://biospectrumindia.com/news/97/8058/siemens-healthineers-new-brand-for-siemens-healthcare-business.html https://biospectrumindia.com/news/97/8058/siemens-healthineers-new-brand-for-siemens-healthcare-business.html Mon, 09 May 2016 11:16:43 +0530 It is unique and bold and best describes the Healthcare organization and its people - the people accompanying, serving and inspiring customers - the people behind outstanding products and solutions. "We have an exceptional track record of engineering and scientific excellence and are consistently at the forefront of developing innovative clinical solutions that enable providers to offer efficient, high quality patient care. Going forward as Siemens Healthineers, we will leverage this expertise to provide a wider range of customized clinical solutions that support our customers business holistically. We are confident in our capability to become their inspiring partner on our customers' journey to success", explained Mr Bernd Montag, CEO of the company. "Our new brand is a bold signal for our ambition and expresses our identity as a people company - 45,000 employees worldwide who are passionate about empowering healthcare providers to optimally serve their patients." As part of its Vision 2020 strategy Siemens AG announced nearly two years ago that its healthcare business would be separately managed as a company within the company with a new organizational setup. Siemens Healthineers will continue to strengthen its leading portfolio across the medical imaging and laboratory diagnostics business while adding new offerings such as managed services, consulting and digital services as well as further technologies in the growing market for therapeutic and molecular diagnostics. The name of the legal entities will remain unchanged.     ]]> https://biospectrumindia.com/features/97/7884/wipe-health-woos-with-wearables.html https://biospectrumindia.com/features/97/7884/wipe-health-woos-with-wearables.html Fri, 06 May 2016 13:02:30 +0530 Healthcare and fitness are the two segments where wearables are gaining increasing acceptance. Wearables fitness bands are becoming more and more desirable. From general-purpose devices like fitness bands that track steps, calorie intake etc to the more serious diagnostic devices, wearables are slowly getting integrated into the healthcare system. Wearables for wiping worriesWearable technology companies are addressing several different aspects most prominently lifestyle/active monitoring, smart watches that can connect with phone and provide notifications and medical grade monitoring of one's health. "In an emerging economy like ours, remote diagnostics and medicine is a huge need. Wearable technology can help by taking most of the diagnostics out of hospitals and into the patient's phones," says Mr Anshuman Singh, founder, RetiSense, a start-up firm developing Stridalyzer, an injury-preventing running wearable (insole). With innovation and advancements in wearable technology, specifically miniaturization of sensor technology, wireless communication technology, and wearable computational technology has made possible the development of small, light, durable, comfortable, safe and low cost wearable medical devices. "The miniaturization of wearable devices has also enabled clinical monitoring beyond the hospital area, in the home or during outdoor activities," said Ms Shivani Jaiswal, associate manager, IndustryArc, a market research and consulting firm. At present majority of the companies are offering general purpose devices that offer activity tracking. (e.g. step counts, general estimate of physical activity etc). "However, we are starting to see more purpose-built products and services that fit particular scenarios such as specific fitness activities (running, swimming, golf etc.) and health conditions (e.g. diabetes, neurological disorders, chronic diseases) ," mentioned Dr Alick Law, director of marketing and business development, Sensoria. Sensoria designs, develops, and produces body-sensing wearable devices.   Its products include anklet and sensor infused socks that provides step counting, speed, calories, altitude, and distance tracking data as well as tracks cadence, foot landing techniques, and weight distribution on the foot as users walk and run; and fitness bras and t-shirts with heart rate monitor that provides heart rate data. Speaking on the similar lines, Mr Mohammed Hussain Naseem, co-founder and CEO-2mpower Health Management Services said, "Many wearable technology companies have mushroomed in the past one-­-year. Most of them are focusing on low hanging fruits - preventive care through quantification of data. However, many specialized companies are focusing on more urgent issues. They are developing wearable medical technology products for disease management, efficient medical measures and real time response during emergency situations." 2mpower is a technology company focused on preventive health management. GetActive is their current product which promotes physical activity. Wearables: Fancy gadgets or serious health devices?Most of the times wearables are seen as a cool, intelligent fashion accessory but can it evolve beyond that to become an essential part of healthcare? It can be asserts Dr Srinivasan Murali, CEO at SmartCardia, a spin-off from the Embedded Systems Lab (ESL), EPFL. SmartCardia's revolutionary wearable technology enables new fitness, gaming, wellness and medical applications. He said, "While current fitness bands are for gadget lovers and early adopters, we will see a wave of products in the near future that would monitor more concrete health parameters, such as blood pressure, stress levels and would connect the users with specialists." "The question shouldn't be whether they can become a part of the healthcare system, but rather how soon it'll occur. A lot of movement in the industry is already in place to service this exact gap, Mainstream wearable devices through sponsored wellness programs, and pharmaceutical and provider networks will leverage wearables to integrate with the other content and services around key solutions that go beyond prescriptions and pills to drive meaningful behavior change," said Mr Pratik Saraogi, founder and CEO at Oxstren Wearables, a start-up developing fitness accessories. Its product line include smart workout gloves, smart Wristwraps and smart headbands. There are active research projects exploring the potential of these products to improve patients' lives. For example, recently Biogen and PatientsLikeMe's study to quantify physical activity of patients with multiple sclerosis (MS) between doctor appointments finds that wearables improve walking ability in MS patients. "MS impairs the ability to walk for many people, yet we only assess walking ability in the limited time a patient is in the doctor's office. Consumer devices can measure number of steps, distance walked, and sleep quality on a continuous basis in a person's home environment. These data could provide potentially important information to supplement office visit exam," said Dr Richard Rudick, vice-president, value based medicine, Biogen, while releasing the study result.Hopefully we will see more conclusive outcomes in the near future. At present, the major market is for activity trackers. The real value add to the consumer would come when we have wearables that can track medically accurate information, helping in preventing health risks (such as cardiac issues) and allowing personalized medication and treatment. Growing popularity of wearablesThe fact that nearly every month there is a new wearable in the market says something about the growing fascination for these wonder gadgets. Many factors are spurring the growth of these health devices. Consumer awareness of healthy and active lifestyles is one of the major factor why everybody want to wrap their wrist with these health bands. Dr Murali said, "Activity tracking and having a healthy lifestyle is picking up. There is a strong need for health monitoring devices that could help the users monitor regularly their health conditions, such as sugar level or blood pressure." As per Ms Jaiswal, "The growing popularity of wearables are increasing caused by following reasons like health consciousness among people, increase in health consumer behavior among people, greater health trend to move from hospital care to home care and subsequently to personal care and so on." Also, increasing lifestyle diseases that demand continually monitoring of the vital stats also fuel the demand for these wearable. "With heart disease and diabetes remaining two of the major causes of death globally, keeping a healthy and active lifestyle has never been more important. Our UP bands helps people better understand their health and well-being by tracking sleep, activity, and nutrition along with clear tools - through our UP app and Smart Coach system - to help them take action and live better," said a Jawbone Spokesperson. The fact that most of the wearables, especially wrist bands also makes for a very good looking accessory could also be one of the reasons that people are drawn towards it. This is a hype cycle, when people are intrigued and experimenting this new technology. The benefit it provides today to an individual is limited and utility is "good to have." It has no real urgency for adoption, says Mr Naseem. Consumer TractionAn Accenture survey (Accenture Digital Consumer Tech Survey 2014) found that more than half of consumers (52 percent) are interested in buying wearable technologies such as fitness monitors for tracking physical activity and managing their personal health. The survey of more than 6,000 people in six countries - Australia, Canada, India, South Africa, the United Kingdom, and the United States - showed that many are also interested in buying smart watches (46 percent) and Internet-connected eyeglasses (42 percent). Among the six countries, consumers in India were most interested in buying fitness monitors (80 percent), smart watches (76 percent) and Internet-enabled eyeglasses (74 percent). "Wearables are selling as an 18 billion dollar business. We have companies like Garmin, Fitbit and Jawbone doing extremely well. A lot of people now are getting health conscious so people are buying devices. For some people it is becoming a social statement, and people want to show off their bands. But we do see the trend changing, said Mr Chirag Jagtiani, founder and CEO at Fitkat Inc. Fitkat is an activity tracker that tracks your steps, calories, water intake and is also a ct as a pill reminder. The Wearables are being successfully used in home healthcare, remote patient monitoring (RPM), fitness and sports etc among others. "I think adoption has been steadily increasing. Momentum has picked-­-up in countries like US and some parts of Europe. InternetofThing (IoT) is a big opportunity and wearables are an integral part of this revolution. Consumers are intrigued, experimenting and assessing the utility. As companies in wearables space, we need to give more tangible reasons its adoption to consumers," said Mr Naseem. Market research reports are very bullish about the wearables industry and pegged it to be the next billion dollar industry in the years to come. Trends: Present and future Wrists band undoubtedly at present are synonyms with the wearables but moving on to the future we will see different forms of these wearables and the future of this space will involve more than just a wrist band. "Technology is fast changing in the wearables market. The next generation devices would be patches that can stick on different parts of the body and obtain clinical parameters, such as the ECG. We will also see electronic skin tattoos that a user could wear for a week or so using an adhesive, and would hardly notice even the existence of the patch. We will have sweat sensors that could provide many of the data that we usually obtain using blood tests today," said Dr Murali. Wearable blood glucose monitors is another possibility that can surge in the coming future. "The blood glucose monitors are becoming extremely important as persons suffering from diabetes are increasing. Therefore, as the diabetes prevalence rate becomes high across the globe with expensive diagnosis, it is contemplated that wearable blood glucose monitors will be adopted at mass level," said Ms Jaiswal. "We can speak for Jawbone and we can clearly say that the UP platform and hardware continue to grow globally - People love the design and feel of UP, which is a huge competitive advantage for us. People care about it making a difference: we are the only platform delivering Insights and behavior change helping people not just see their data, but understand it, and use it to change their behavior. And stepping into the future, we will see more multi-sensor devices like UP3, that take the sector and these devices to another level - We have over 1000 granted or pending patents and no other company matches our expertize around multi-sensors," said Jawbone's Spokesperson As per Mr Saraogi, primary wearable devices will act as central connectors for all kinds of devices and information. Today the smartphone is a de facto wearable device-a central hub for accessories and data gathering. In time, smart watches and smart glasses will emerge as key primary devices, acting as a central collection portal for different wearables. Allocations of these hubs may serve to gather and host specific data, as in the Medical field, or serve more broadly as integrating hubs, like the Apple Health Kit. He further added, "Secondary wearable devices will be intended to capture specific Action or measurement, data that can then be funneled back into a primary Wearable device for more comprehensive context, analysis and, ultimately, Actionable insight. Examples of secondary wearable devices include shirts, Shoes, helmets, fitness bands, badges and more. These secondary devices will be companion devices to primary wearables-and as secondary devices become more prolific and on point, the quality of data will improve, making the entire Wearable ecosystem more powerful, more impactful and more actionable." The future of technology is wearable and there is no doubt about that. However the form factor will undergo a lot of iteration over the years. "I see the biggest scope of such integrating with textile. Clothes are something we will always wear and be passionate about. So when such technologies start being incorporated into textiles then there will be a dramatic rise in acceptability of such products," said Mr Aanan Khurma, co-founder at Observe Design Inc. Observedesign is a healthcare innovation start-up focused on reducing healthcare associated infections in hospitals with innovative design and technology solutions. Its integrated platform allows healthcare facilities to observe, record and analyse the adherence to infection control protocols in their facilities. Most apparel brands like Ralph Lauren and Under Armour are realizing this opportunity. Ralph Lauren has launched (available for $295) PoloTech Shirt, which works with an iPhone or Apple Watch to put real-time workout data in the palm of your hand. Created exclusively for use with the shirt, the PoloTech App offers live biometrics, adaptive workouts and more. The shirt seamlessly melds modern innovation with an iconic look that is unmistakably Polo. Similarly, Google and Under Armour are also working on connected clothing. This space as we know it going to change dramatically. Market in 2020 Global wearable medical device market is growing at a CAGR (compounded annual growth rate) of 21.3 percent from 2014-2020 and is estimated to reach to $ 41,368M by 2020 says IndustryArc. Industry is positive that Indian wearable industry which is in infancy at present will get mature over the next five years. "In India, the market is just opening up, and by 2020 we will have 3 or 4 big players in the field of wearable health monitoring," said Dr Murali. By 2020, wearables would start getting mainstream adoption. "We will see various devices (e.g. smart watches, smart shoes, smart clothing) being adopted by consumers, and various services (e.g. payments, security, personal identification, healthcare diagnostics, etc) will be offered by all major industries," said Mr Singh. Indian market is lagging by seven years in wearable space as compared to the US. But the main reason for this is the current UTILITY of wearables is minimum on solving burning issues. "It's used more for behavior change, which has high resistance in countries like India. By 2020, as wearables come in mainstream, adoptions will be at a very high pace, similar to mobility," said Mr Naseem. As with most of the trends wearables growth will dependent on the economy. A lot of which depends on how industries, GDP, and how our economy shapes in this defining moment. "As of now, the wearable tech market is limited to the higher income strata of the Indian market, as compared to a 25 percent adoption rate in the US but the combination of the growing awareness, cheaper production, Costs, flash sales, only point out that this can turn into the next frenzy with a CAGR higher than E-Commerce!" concluded Mr Saraogi.     ]]> https://biospectrumindia.com/news/97/7724/iscr-announces-winner-of-clinical-trials-day-patient-logo-contest-.html https://biospectrumindia.com/news/97/7724/iscr-announces-winner-of-clinical-trials-day-patient-logo-contest-.html Fri, 06 May 2016 11:35:57 +0530 Ms Meryl Mammen, a patient of Pompe Disease, has been announced as the winner of the logo design contest announced by the Indian Society for Clinical Research (ISCR) to mark International Clinical Trials Day which falls on May 20th. The logo design contest was built around Patients First, which is ISCR's theme for the day. Ms Meryl Mammen, a 26 year old post graduate in psychology who lives in Ghaziabad, developed the design as a tribute to patients who take a big leap of faith in participating in clinical trials to help bring better medicines to patients worldwide. Meryl's winning logo will be used in all communication and creative collateral for this year's International Clinical Trials Day. Ms Meryl, who suffers from a rare genetic disorder called Pompe Disease, has been through a series of medical consultations and misdiagnoses before her condition was finally diagnosed at the age of 21. She speaks of the many challenges of living with Pompe Disease and says, "I envision a day when there is a cure for Pompe Disease so that patients can have a better quality of life. If not a cure, at least better treatment options to make our lives easier, as what we have access to at present is simply not good enough." ISCR's logo design contest for patients was a creative way of integrating patients into the commemoration of an important day for the clinical research fraternity and to encourage deeper engagement with patients. Ms Suneela Thatte, President, ISCR said, "We congratulate Meryl on this well-deserved win. This contest was a good opportunity for us to show appreciation of the important role that patients play in clinical research and to incorporate the patient's voice in all our communication. It is for patients such as her and thousands of others that we can continue in our mission to find better and more effective treatment therapies for patients."   Explaining her winning logo, Ms Meryl said, "The courage and strength of patients who participate in clinical trials in the hope of saving the lives of thousands of others like them is what inspired my logo. My design is symbolic of the patient taking a leap of faith (represented by the heart) to help cure disease (curing of disease represented by rings) through clinical trials." The rings or circles also represent the positive ripple effect created when patients participate in a clinical trial. And the leap of faith is a leap of faith of patients in the doctor, in the promise of better treatment or cure and in the manner in which the trial is conducted. Patients First is ISCR's theme for International Clinical Trials Day. It is a theme that acknowledges patients who, through their participation in clinical trials, have made new medicines and treatment possible; and a theme which reflects a commitment to patients who are waiting for new treatment and therapies.   ]]> https://biospectrumindia.com/news/97/7064/agilent-introduces-new-atomic-spectroscopy-platform-.html https://biospectrumindia.com/news/97/7064/agilent-introduces-new-atomic-spectroscopy-platform-.html Thu, 05 May 2016 12:00:21 +0530 Agilent Technologies has introduced a new addition to its lineup of inductively coupled plasma-optical emission spectrometers. The Agilent 5110 ICP-OES will enable scientists to perform faster, more precise ICP-OES analysis than ever before in food, environmental and pharmaceutical testing as well as for mining and industrial applications. The new system builds on the company's breakthrough 5100 ICP-OES, which captures axial and radial views of plasma in a single measurement, enabling laboratories to use half as much argon in the process, saving both time and money. The new system is also a dual-view system. Unlike ICP-OES systems from other vendors, the 5110 enables laboratories to increase throughput without compromising on precision. "The Agilent 5100 revolutionized the ICP-OES market, delivering significant value in terms of cost of ownership, performance, and ease of use," said Mr Philip Binns, Agilent's vice president of spectroscopy products. "The new Agilent 5110 extends that revolution with more cutting-edge innovations." The 5110 includes advances, A fully integrated Advanced Valve System with unique hardware and software technologies that enable ultra-high throughput with excellent precision and ease of use, IntelliQuant measurement for rapid sample screening and simple method development and New diagnostic capabilities that maximize instrument uptime and simplify troubleshooting.   "With the introduction of the 5110 ICP-OES we continue to lead the way in elemental analysis innovation," said Mr Binns. "Our atomic spectroscopy portfolio offers the most diverse application coverage for AA, ICP-OES, and ICP-MS, while our unique MP-AES and ICP-QQQ technologies help customers redefine the way they work."   ]]> https://biospectrumindia.com/features/97/7262/exclusive-the-emerging-new-wave-of-theranostics.html https://biospectrumindia.com/features/97/7262/exclusive-the-emerging-new-wave-of-theranostics.html Wed, 04 May 2016 17:33:11 +0530 Imagine a very tiny capsule injected just below the skin of your arm. The capsule has a sensor capable of continuously measuring blood glucose levels and sends the information to your phone. Well, let's spice it up one level above the notch. Say, when the blood glucose level crosses its threshold, visualize the tiny little capsule releasing a dose of insulin in your blood stream. What this does is offer total freedom from regular needle pricks to measure blood sugar levels, and frees patients from the anxiety of taking the right insulin doses at the right time. Science Fiction Or Reality? Nope, this isn't something straight out of a Steven Spielberg's upcoming science fiction movie. This is Theranostics. A combination of diagnosis with therapy geared to revolutionize and disrupt the world of healthcare diagnostics. "The idea of Theranostics is old," says Dr Biplab Bose, an Associate Professor in the Department of Biosciences and Bioengineering at the Indian Institute of Technology (IIT), Guwahati. "However, the term was coined and gained popularity in recent times, thanks to the development of targeted drug-delivery, microfluidics, and nanotechnology. Both in India and abroad, extensive work is going on to use targeted nano-delivery systems for Theranostics. A prime focus on this is to create drug loaded nanoparticles that are suitable for both in-vivo imaging and as well as for targeted drug-delivery." Theranostics is the development and use of molecules for both diagnostics and therapeutic purposes, thereby providing Precision Medicine to patients - first in a clinical setting - for further understanding their diseases at molecular level, and then prescribing specific medicines.   "For example," adds Dr Aman Sharma, the Founder of Pune-based start-up ExoCan Healthcare Technology which focuses on Oncodiagnostics and Therapeutics space. "Fever in different patients has similar symptoms like rise in the body temperature. However, it may occur due to different infections. Hence, detecting the infection, whether bacterial or virus, accurately and then providing specific therapy is addressed by Theranostics." The classic example is the use of Herceptin drug, a monoclonal antibody (mAb), against HER2 receptor, a specific protein expressed in almost 30% of breast cancer patients, to treat grade IV breast cancer patients. Theranostics approach would be to first identify HER2 over-expression in breast cancer patients by a diagnostic test, and then prescribe Herceptin as a drug to those who have this over-expression. In other words, Theranostics deliver customized treatment plan for patients, resulting in the availability of right drug, for the right patient, at the right time. "This combining of therapeutic and diagnostic modalities for personalized treatment of patients enhances drug efficacy and ensure patients safety," comments Dr Arumugam Muruganandam, MD & CSO of Bangalore-based Affigenix Biosolutions. "At present in India, patient-centered care which focuses on integrating two disciplines such as imaging and therapy for targeted drug-delivery at the site of action is in limited practice except in specialty hospitals for cancer and cardiovascular diseases (CVDs)." Indian Theranostics Scene Molecular theranostics is a major field that involves small biochemical moieties and biomacromolecules. India is yet to get its share of modern Theranostics field. There are a few start-up companies in India that are operating in the Theranostics and Personalized Medicine in general. "Theranostics and Personalized Medicine are very nascent sectors in India, as compared to the West, where personalised medical approaches have reached the clinic on a much larger scale," shares Dr Nilay Lakhkar, Founder & CEO, SynThera Biomedical, a start-up focusing on manufacturing and commercialization of biomaterials-based medical devices. The West may be early adopters of the evolving field of Theranostics in to their routine healthcare as it promotes safer and more efficacious pharmacotherapies to patients which is supported by patients, and encouraged by Insurance companies. "Whereas in India, we may gradually implement Theranostics across urban areas as it becomes affordable with appropriate testing systems, and expertise becomes available," remarks Dr Arumugam. Currently in the West, a severe disease like cancer is treated through precision medicine. For example, mutational typing of a cancer is first performed and the right therapy or drug is then prescribed based on the mutation. Nanoparticles made of Iron Oxide and Gold are increasingly adapted for both in vivo diagnosis and treating cancer. Here the diagnosis is performed by using existing clinical imaging techniques such as MRI (iron oxide) and X-ray or CT (Gold), where in following the intravenous injection, the nanoparticles accumulate in the tumor tissue to provide precise contrast thereby differentiating it from normal tissue. Considering the Indian population and its disease burden, Theranostics will eventually enter the Indian healthcare market in a big way in the next couple of years. "In the next 5 or 6 years, we would see some form of Theranostics in clinical use, particularly for solid tumours. I believe oncologists along with radiologists will probably be the first to introduce Theranostics in clinics," Dr Biplab predicts. However, the key question is whether India will be able to develop any such products indigenously? There are several lacking factors, points Dr Biplab. "Factors include lack of access to advanced instruments. India is lacking in the development of real-life microfluidic devices. However, Indian scientists have gained reputation in the field of nano-materials, including nano-drug delivery systems. Unfortunately, Indian pharma companies are slow to pick the thread from laboratories, and have not yet built upon the developments that have happened in our academic labs," he stresses. Also, the patients in India are not much clinically educated. "One of the fundamental issue is cost factor, and the absence of active clinical trials and proper counselling in Government hospitals; and lack of high throughput facilities are among many reasons which retard the development of opportunities in Theranostics in our country," highlights Dr Aman. The key areas of Theranostics have developed rapidly in the last few years including Photo-Immunotherapy (PIT), and nano-particle-based drug-delivery and imaging systems. "We may soon see some successful clinical trials in these two segments," reveals Dr Biplab. In a way, Personalized Medicine, Theranostics and Precision Medicine are all interlinked from the view point of treatment. Dr Arumugam explains, "It is all about the right drug, at the right time, for the right patients. Theranostics mainly refers to treatment strategy that combines therapeutics with diagnostics as one treatment unit. Personalized Medicine imply that drugs are being customized for each individual patient. In Precision Medicine, the dosing regimen is designed for patients based on drugs used, condition to be treated, genetics, environmental and lifestyle factors." Theranostics is important for both Personalized as well Precision Medicine, feels Dr Biplab. "I would say, it is important more for Precision Medicine. Take the example of a drug-delivery system that combines targeted drug-delivery and imaging of drug-delivery. Such drug-delivery system would allow the physician to deliver the drug to specific location as well as confirm it by imaging," he notes. The field of Theranostics is aided by Genomics, Proteomics, Organic or Inorganic Chemistry and Pharmacology. This makes it a broader field of interest, which cannot be catered by one researcher. "In a global perspective, active collaboration is very important for rational and innovative ideas to be seeded for true emergence of Theranostics. In Indian scenario, this is building up with many thematic inter-institutional and industry-academia proposals being funded by DBT, DST, ICMR and the likes. India ranks 3rd, with 1st and 2nd being China and USA, in research outcome in field of Nanotechnology, and a significant percent of publication is related to Nanotheranostics, funded mostly by DST's Nano Mission. India can be a global leader in the field, if collaboration between scientists in the above mentioned field is made stronger and sustained for a significant period of time," elaborates Dr Asifkhan Shanavas, Scientist, Institute of Nano Science and Technology (INST), Department of Science & Technology (DST), Government of India. Theranostics and Personalized Medicine is bridged by Pharmacogenomics, a field that studies the effect of genes on a person's response to drugs. This relatively new field combines Pharmacology and Genomics to develop effective, safe medications and doses that will be tailored to a person's genetic makeup. Personalized Medicine also takes all non-genetic and environmental factors in to account, including gender, age, diet, lifestyle, and even the intestinal microflora. Under this regime, the doctor will advise the patient to first take an in vitro diagnostic test or a single in vivo imaging protocol with the Theranostic agent to identify its efficiency to selectively accumulate and act in the pathological site. "According to the therapeutic outcome," explains Dr Asifkhan, "the physician decides the course of treatment for the patient. Furthermore, information from non-invasive imaging on the accumulation of nanomedicine formulations in potentially endangered healthy tissues such as heart and brain may help in excluding patients from further treatment. Consequently, combination of non-invasive imaging and disease-targeted drug delivery has significant potential for Personalized Nanomedicine-based chemotherapeutic interventions, to achieve delivery of the right drug, to the right location, in the right patient, at the right time." India's Opportunities At Hand Indian population is genetically very diverse. Scientifically, the West-built Theranostics tools may not work well for Indian population. Moreover, the mutations or genomic anomalies present in the Western population may not be harbored by the Indian patients due to different genetic makeup. Dr Aman explains, "Hence, development of indigenous pool of databases for Theranostics in various diseases is what we should start with. Three vital opportunities lie ahead for Theranostics in India. Firstly, disease-specific database (diabetes, heart disease, and cancer can be taken on priority) generation for personalized medicine by genotyping known mutations and validation of existing biomarkers. "Secondly, setting up minimal infrastructure for Theranostics tests in hospital level settings. Lastly, there must be patient counselling centres inside hospitals to make patients aware of their disease type. Economically, we are one of the biggest markets for Theranostics as mentioned earlier due to very divergent genetic makeup of the population. The Government can encourage public-private partnerships to promote Theranostics research in collaboration with pharma and biotechnology giants and improve infrastructure for such opportunities." For advanced diseases like cancer, the greater diversity in Indian population creates a window of opportunities for Theranostics or Precision Medicine. Dr Nilay opines that opportunities do exist for Indian companies to focus on cutting-edge Theranostics products and services with demands being driven by a growing, affluent, and knowledgeable patient pool. "However, the Indian market for Personalised Medicine is still very much a niche market focused on high-net-worth individuals (HNWIs), and upper middle-class consumers, since these therapies are highly expensive, and not yet easily scalable," he justifies. Dr Biplab believes that the first use of Theranostics would probably be in oncology clinics, where physicians would use targeted drug-delivery for solid tumours, and would be able to image or monitor such delivery in real-time. "Cancer is one of the leading causes of death in India, and its burden is increasing. Unlike many other disease, Precision Medicine is crucial in cancer. In near future, we may see several players in cancer Theranostics to enter the Indian market," adds Dr Biplab. India also has vast potential to exploit the Theranostics especially in nano Theranostics for patient care, provided the regulation and funding support system helps in the discovery by academic sector; development by biopharma sector; and adoption by healthcare providers for personalized treatment. "The middle income group population is growing in India, and medical tourism is on the rise, and my guess is that wealthy patients may be more willing to pay for personalized treatments," Dr Arumugam says. The sub-continent has significant population affected by both communicable (infectious disease of bacteria, fungi and virus) and non-communicable (cancer, myocardial infarction etc) diseases. Dr Asifkhan states that a significant percentage of these patients fail to respond to standard treatments due to emergence of drug resistance, which warrants newer effective strategies with rapid molecular diagnosis followed by rationally designed treatment. "Early detection and treatment is also vital to reduce such disease burden. Theranostic approach can have tremendous impact in this line along with appreciable reduction in cost involved due to the selective treatment protocol, i.e., Personalized Medicine," he highlights. Overcoming Obstacles Therapy and diagnosis go hand-in-hand, and both are expensive for a country like India, "Patient affordability is going to be a big challenge," stresses Dr Arumugam. "There is also perceived loss of opportunity by drug manufacturers for particular drug to be used by cherry-picking patients for treatments as it reduces the market potential of the drug. Educating doctors, patients, Insurers and regulators will be a challenge as Theranostics does not provide guaranteed outcome yet." Theranostics is closely related to patients. "Hence we should educate more patients about their disease types and right therapies, and how it can enhance lifesaving chances in case of a deadly disease," recommends Dr Aman. There is a need for the existence of certain private equity bodies, venture capitalists and Government schemes who can invest in high-risk upcoming areas like Theranostics. It also calls for setting up infrastructure to create biobanks, tissue banks, and minimal research setups in hospitals and medical colleges for creating our own indigenous databases. Dr Aman continues, "One of the most important shortcomings is the lack of good research in this area in our country. The Government should setup special grants schemes to promote biological research in Theranostics, and should also make a provision to bring research entities, medical colleges, and hospitals under one umbrella to make the best use of existing knowledge and resources." Just like drug development, work on Theranostics requires clarity on specific clinical requirements, understanding market dynamics, and the limitations of current technologies. "Therefore, successful development of a Theranostics requires active collaboration between academia, clinicians and the industry. In India such collaborations are rare, if not absent," Dr Biplab mentions. Dr Asifkhan also believes that cost will play a major role in translation of new Theranostic agents to clinics. He opines, "The foremost challenge is to develop these agents at lower costs, so that their industrial scalability will not have profound effect on its marketing costs, if they clear clinical trials. "Secondly, time is a crucial player in bringing some of the promising agents into market, as pre-clinical and clinical trial takes years to complete, demanding simple and efficient models such as organ-on-a-chip that provides quicker results on par to human trials. It is also important for Indian researchers to take up innovation as a key element to provide state-of-the-art Theranostic solutions." Strict Competition? Experts believe that the real completion is yet to begin perhaps due to great investments required in any Theranostics programs. One of the reasons is that it requires a huge sample base to start with, and compilation of information to reach statistical end-points. "Subsequently, that information is then put-up into R&D to design effective therapies for patients. The whole process is far more costly than just developing a common drug which would be used by bulk and unsorted population. Though, the field has far reaching implications for mankind, it is yet to take off to reach to its newer heights," says Dr Aman. Dr Arumugam also believes that though Theranostics has good potential it does not have any competitions at the moment. "In India, both doctors and patients may prefer to go with 'one-size-fits-all' approach, and continue with trial-and-error method for treating patients. Potential impact on revenues by the 'slice-and-dice' approach in selecting patients for personalized treatment will prevent wide acceptability by bigger hospital managements and biopharma companies, and may resist to change," he emphasizes. The Future While there are several advancements in molecular Theranostics to quote, the most attracting is in the field of Radiopharmaceuticals. They are successfully being used at Indian premier institutes such as Rajiv Gandhi Cancer Institute & Research Centre (RGCI&RC) among others. Dr Shailaditya Sengupta of Massachusetts Institute of Technology's (MIT) Brigham and Women's Hospital (BWH) developed nanoparticles which first delivers an anticancer drug specifically to tumour tissues, and if the tumour starts dying or regressing, it then starts lighting up the tumour in real-time. This is a major finding to first treat and then have a follow-up on the course of a disease. In longer terms, Theranostics would pave the way for a healthier world around us. Advancement in Nanotechnology, Biosensors, Bioelectronics, Pharmacogenetics, Cancer Immunotherapy, Biomarker Profiling, Companion Diagnostics, and the ability to combine therapeutic and diagnostic capabilities into one single agent (nanomaterials) have already started a ripple effect in healthcare. "The only limiting factor is going to be the affordability for personalized treatment," states Dr Arumugam. In the future, patients who suffer from chronic diseases will have a combination of wearable devices and implantable Theranostics. Dr Biplab observes, "These will monitor our critical health parameters in real-time and intervene at the right time. Considering the speed in development of micro-fabrication and micro-electronics, I believe, such devices will be in our homes within the next 10 years." Five years down the line, breakthroughs in Theranostics R&D may bring down treatment costs, and increase scale-up potential. "A focus on building strategic partnerships with global players in the pharma and diagnostics sectors may be the way forward for Indian companies in this space," suggests Dr Nilay. Through Theranostics, the treatment costs might go up initially, but a faster disease recovery would be ensured. Dr Aman voices, "Theranostics might improve patient survival chances especially in cancer and heart disease patients. In totality, a greater health, emotional, and life security is what the goal of Theranostics is." At the moment, India does not have a statistical data on molecular nature of disease(s) among the Indian population. Nevertheless, combining the three major diseases including diabetes, heart disease, and cancer, Theranostics market should value anywhere between US $300-500 billion in the next 5 years. In the coming years, a better collaboration between the fields of molecular or nano Theranostics and OMICs -- Genomics, Epigenomics, Transcriptomics, Proteomics and Metabolomics -- is expected to realize the dream of personalizing medical interventions, especially for evading disorders such as cancer. ]]> https://biospectrumindia.com/news/97/5048/mega-merger-ims-health-and-quintiles-to-combine.html https://biospectrumindia.com/news/97/5048/mega-merger-ims-health-and-quintiles-to-combine.html Wed, 04 May 2016 12:00:01 +0530 IMS Health Holdings and Quintiles Transnational Holdings has announced that their respective boards of directors approved a definitive merger agreement, pursuant to which the companies will be combined in an all-stock merger of equals transaction. The merged company will be named Quintiles IMS Holdings, Inc. Under the terms of the merger agreement, IMS Health shareholders will receive a fixed exchange ratio of 0.384 shares of Quintiles common stock for each share of IMS Health common stock. Upon completion of the merger, IMS Health shareholders will own approximately 51.4 percent of the shares of the combined company on a fully diluted basis and Quintiles shareholders will own approximately 48.6 percent of the combined company on a fully diluted basis. Quintiles Chief Executive Officer, Mr Tom Pike, said, "This combination addresses life-science companies' most pressing needs: to transform the clinical development of innovative medicines, demonstrate the value of these medicines in the real world, and drive commercial success. We are bringing together two best-in-class leaders. I'm confident that together we will make our clients even more successful." Mr Ari Bousbib, chairman and chief executive officer of IMS Health, stated, "Together our solutions will enable differentiation in the CRO market, advance Real-World Evidence capabilities, and deliver comprehensive commercial solutions for our clients. This powerful combination brings together leading technology and analytics with deep scientific expertise delivered on a global scale by our 50,000 immensely talented professionals in more than 100 markets. Our combined business will accelerate growth, yield greater operating efficiencies and provide more flexibility for future expansion." The combined company expects to maintain dual headquarters in Danbury, CT, and Research Triangle Park, NC. Mr Ari Bousbib, chairman and chief executive officer of IMS Health, will become chairman and chief executive officer of the merged organization. Tom Pike, chief executive officer of Quintiles, will become vice chairman. The company's Board of Directors will be comprised of six directors appointed by the Quintiles Board of Directors and six directors appointed by the IMS Health Board of Directors. The lead director will be Dr Dennis Gillings.   The transaction is subject to customary closing conditions, including regulatory approvals and approval by both IMS Health and Quintiles shareholders and is expected to close in the second half of 2016. Shareholders of IMS Health owning approximately 54 percent of the common stock of IMS Health and shareholders of Quintiles owning approximately 25 percent of the common stock of Quintiles have entered into agreements to vote the portion of their shares over which they have voting power to vote in favor of the transaction. The companies intend to refinance certain debt in connection with the merger. Committed financing has been obtained. IMS Health's legal advisor is Weil, Gotshal & Manges LLP and its financial advisor is Goldman, Sachs & Co. In addition, Morris, Nichols, Arsht & Tunnell LLP served as legal advisor to the independent committee of the IMS Health Board of Directors. Quintiles' legal advisors are Bryan Cave LLP and Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, LLP, and its financial advisor is Barclays. Simpson Thacher & Bartlett LLP served as legal advisor to Quintiles' independent directors.   ]]> https://biospectrumindia.com/news/97/8275/make-in-india-impact-on-biosciences-sector.html https://biospectrumindia.com/news/97/8275/make-in-india-impact-on-biosciences-sector.html Wed, 04 May 2016 12:00:00 +0530 In September 2014, Prime Minister Mr Narendra Modi launched 'Make in India' program, rolling out the red carpet to investors through a string of measures including easier norms and rules aimed at transforming India into a manufacturing hub. BioPharma and Medtech were amongst the 25 sectors that the government has identified that are covered under the Make in India plan. In the recent times, the campaign has created a lot of buzz, and has been a topic of discussion at various business meetings. But has there been any concrete steps to boost this campaign especially in the biopharma and medtech sector? BioSpectrum tries to find out: Impact of Make in India:There are some contradictory response to this. Though, some believe that the campaign has failed to meet any expectations, some say it is a move in the right direction. Speaking for the Medtech sector, Dr GSK Velu, founder and managing director, Trivitron Group of Companies, "There are some significant benefits to this move which will bring down the cost of medical equipment and devices by 30 to 50 per cent and also the uptime of equipment in tier 2/3/4 towns will improve due to easier availability of spare parts. Local production will also lead to additional employment generation, local R&D and local skill development programmes. Moreover, the PM's vision has already attracted some major MNC players are attracted to set up low cost manufacturing units in India to serve emerging market." The campaign has a positive impact on the generic pharmaceutical firms' feels, but for the biotech sector nothing significant, feels Mr N Venkat, co-founder, Vyome Biosciences. He said, "Nothing much is yet visible in the PM's Make in India Campaign for the Biosciences/Medtech Industry and the Players. The policies and investment thesis only talks about the increase in investment but concrete plans should be brought to the fore front. There has been a positive effect, though, for the Generic Pharmaceutical Players."   Any positive outcomes?Definitely, with the Indian government supporting make in India all industries including healthcare are further sharpening their focus in India, said Ms Rekha Ranganathan- Global General Manager, Mobile Surgery & Head, Philips HIC. She added, "We expect even higher contribution from the region in the months to come. HIC, which aims at enhancing access to affordable healthcare in emerging markets, as well as across the globe is a key contributor to Philips globally. There has been a substantial increase in our healthcare footprint. Over the last few years, the facility has successfully launched 5 global products, doubled unit growth and filed multiple patents, making it a very important hub globally." Currently the government is willing to listen to the views of Indian Manufacturers in this segment and implement changes to the tariff structure and regulatory structure in the upcoming budget. "Indian Manufacturers are of the view Government should do away with 100% Customs duty exemption for all product categories as this has not benefited the end patients over the past two decades. As per the recent reports in the media, a Drug Eluting Stent which is being manufactured for Rs 5000 is being imported to India with around Rs 40,000 with nil Customs Duty and the end patient pays around Rs 1.5 lakhs for the same. Hence there is no rationale for Zero Customs duty for any Finished Goods imports and there should be at least 20% customs duty exemption between Finished Goods imports and Raw Materials/ Components import for ultimate manufacturing in the country," Dr Velu. "Nothing significant positive effects have been visible yet for the biotechnology industry, except for the momentum that Indian Pharmaceutical industry already has by being a global supplier of pharma generics. The trickledown effect might be visible some time later," said Mr N Venkat. Though at present, the effect might be negligible, the industry is optimistic that the future hold good promise for the campaign.   Major announcements/ initiatives to promote the sectorsIndian medical devices industry is extremely import dependent almost 70 percent. To boost domestic manufacturing, the government has announced 100 percent FDI in medical devices. Speaking for the Biotech sector Mr N Venkat says that as of yet, there hasn't been any major announcement which complements or supports the campaign for the biotechnology industry's. It may be noted that to realize the vision of PM Modi's vision of 'Make in India', department of chemicals and fertilizers had set up three task force, among which one was on 'Promotion of Domestic Production of High End Medical Devices and Pharmaceutical Manufacturing Equipment'. The Task Force has given recommendations to address concerns and constraints facing the sector and suggested measures that would augment domestic production of medical devices. The Task Force has recommended measures to enhance policy and institutional support; suggested strengthening of infrastructural support; and, recommended fiscal and financial support to the sector. In addition, the Task Force has also recommended measures for creating an institutional set-up for efficacy & safety testing, promoting skill development aligned to the need of the industry, strengthening the R&D Capability of the sector, pricing strategy for the sector and conducive regulatory environment.   Making India a manufacturing hubSo, how do we make India a manufacturing hub as envisioned by our PM, "By giving more significance to Indian companies than giving more importance to foreign companies at large can transform the country into a manufacturing hub, said Dr Velu. In order to establish a region as a manufacturing hub two main pre-requisites must be met talent and supplier base. "There is a very young, yet specialized population when it comes to R&D and engineering in India. We have a large base of this population and we need to invest in training this talent to become leaders in healthcare R&D and businesses. The supplier base in India is still at the infant stage in healthcare and we should focus on investing in increasing the supply base and ensure that we have global standards. Philips focus is to really develop and nurture this local base to further innovate and manufacture out of India," said Ms Ranganathan. Mr N Venkat suggests following measure can be taken to make the campaign a success and make India a biotechnology manufacturing hub viz, Creation of an ecosystem for development and capital availability for biosciences innovation and manufacturing units; Creation of optimal, effective and speedy regulatory system for approvals; Better export incentives for biotechnology industry with respect to technology licensing in addition to products' exports, to motivate novel biotechnology oriented companies to invest in and increase exports and Lucrative incentives for the global biotechnology players to set up their operations in India and collaborate with Indian biotechnology firms for joint product and technology development. Time has finally come to turn discussions to decisions.   ]]> https://biospectrumindia.com/news/97/8194/fda-nod-for-medtronics-single-chamber-icds-.html https://biospectrumindia.com/news/97/8194/fda-nod-for-medtronics-single-chamber-icds-.html Tue, 03 May 2016 11:14:22 +0530 Medtronic has received the US Food and Drug Administration (US FDA) approval for the Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators (ICDs). The Visia AF devices can detect previously undiagnosed and/or asymptomatic atrial fibrillation (AF) and monitor recurrent AF, while treating life-threatening rhythms in the lower chambers of the heart. The Visia AF ICD systems will be commercially available in early summer. AF is a condition that involves an irregular quivering or rapid heart rhythm in the upper chambers (atria) of the heart. Because many patients do not experience symptoms, the condition frequently goes undetected, even with traditional external monitors. When left untreated, patients with AF are five times more likely to have a stroke and three times more likely to develop heart failure. The Visia AF ICDs include a proprietary algorithm that detects AF episodes (without a lead in the atrium) and captures AF frequency and duration, information that helps physicians identify AF and tailor treatment for these patients. More than half of all new ICD implants in the US are single-chamber devices. Built on the proven performance of the Medtronic Evera family of ICDs, the Visia AF ICDs include: SureScan Labeling: Approved for MRI scans on any part of the body without positioning restrictions, as well as for MRI scans in 1.5 Tesla (magnet strength) machines Physio Curve Design: A contoured shape with thin, smooth edges that increases patient comfort by reducing skin pressure by 30 percent Greater Battery Longevity: Industry-leading battery longevity (up to 11 years)Sprint Quattro Leads: Paired with the Sprint Quattro family of leads, the most frequently prescribed lead, with more than 10 years of proven performance with active monitoringSmartShock 2.0: An exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms, delivering a 98 percent inappropriate shock-free rate at one year.   In addition, remote monitoring through the Medtronic CareLink Network is available with the Visia AF ICDs, connecting patients to their clinics from home or away. "Early detection of AF is vital to assist physicians in making treatment decisions that can reduce stroke and heart failure risk," said Dr John Liddicoat, senior vice president, Medtronic, and president of the Cardiac Rhythm and Heart Failure division. "These single chamber defibrillators with AF detection capabilities, utilizing our proven Quattro lead - alongside our overall portfolio of AF detection devices - demonstrate our commitment to providing cardiac patients with the latest technology to improve their health." The Visia AF ICDs received CE Mark in 2015. This FDA approval further expands the Medtronic portfolio of MR-conditional cardiac rhythm and heart failure devices, which includes MR-conditional pacemakers, ICDs, insertable cardiac monitors (ICMs) and cardiac resynchronization therapy defibrillators (CRT-Ds).     ]]> https://biospectrumindia.com/news/97/8252/thermo-fisher-scientific-introduces-new-products-for-biopharma.html https://biospectrumindia.com/news/97/8252/thermo-fisher-scientific-introduces-new-products-for-biopharma.html Mon, 02 May 2016 10:57:00 +0530 Thermo Fisher Scientific highlighted its bioprocessing production capabilities "built for biopharma," at the International Pharmaceutical Expo (INTERPHEX) to support its expanding customer base of global biopharmaceutical manufacturers. New products at the show include innovations in single-use technologies, cell culture, protein purification and mass spectrometry. "Emerging markets for precision medicine, continued growth for biotherapeutics and a renewed focus on cost, increase pressure on customers to identify efficiencies in their production processes," said Mr Cory Stevenson, president of Thermo Fisher's bioproduction business. "Our emphasis on best-in-class products across the workflow helps our customers to accelerate innovation and increase productivity." Thermo Fisher has developed a comprehensive protein analytics platform to support microbial and process quality when accuracy and time-to-results are critical. The Applied Biosystems ProteinSEQ Protein Quantitation System, a breakthrough immuno-PCR platform for residual host-cell protein (HCP) and protein A quantitation, is designed for sensitive and robust protein quantitation with dynamic range, providing four orders of magnitude of greater confidence and quality of data throughout the production process. Glycosylation is one of the key critical quality attributes of monoclonal antibody-based biotherapeutics, affecting a biological drug's safety, efficacy, clearance and immunogenicity. The new Applied Biosystems GlycanAssure Glycan Analysis and Quantitation System is the first solution to combine high-throughput and high-data quality in an integrated platform. This helps save labor, time and analysis cost by using a simple sample preparation, a multi-capillary CE instrument and assay-specific software. To enhance productivity while improving protein quality, Thermo Fisher introduced Gibco GlycanTune, a feeding supplement engineered to provide precision and control in predictively shifting glycan profiles. Based on EfficientFeed technology, the feed also enables a multi-fold increase in titers and maximizes bioreactor utilization.   Thermo Fisher's single-use technologies comprise best-in-class bioreactors, mixers, fermentors and ancillary products that enable efficiency, speed and reproducible results. At the core are both standard and custom-built BioProcess Containers, which are specially engineered films configured to fit customers' unique applications and provide process flexibility. Overcoming Technical and Economic Challenges in the Purification ProcessTo address downstream purification challenges, new Thermo Scientific POROS CaptureSelect AAV8 and POROS CaptureSelect AAV9 Affinity Resins are engineered to address the high selectivity and capacity requirements needed for the purification of adeno-associated virus types 8 and 9, which are often used for gene therapy applications. Also featured at INTERPHEX is a novel approach to protein A capture chromatography. Thermo Scientific POROS MabCapture A Select Resin combines high-throughput purification performance at a lower price to reduce the cost of pre-clinical development and process-scale manufacturing. Finally, regulatory changes and increased competition from biosimilar products continue to pressure biotherapeutic drug manufacturers to streamline their analytical processes. The recently launched Thermo Scientific Vanquish Flex system is a UHPLC instrument with a fully biocompatible flow path, sample pre-compression and a broad range of detectors to suit biotherapeutic analysis from intact proteins to unlabeled free glycans.   ]]> https://biospectrumindia.com/news/97/8251/bd-collaborates-with-sight-diagnostics-to-introduce-parasight-malaria-detection-device-in-india.html https://biospectrumindia.com/news/97/8251/bd-collaborates-with-sight-diagnostics-to-introduce-parasight-malaria-detection-device-in-india.html Mon, 02 May 2016 10:32:31 +0530 BD (Becton, Dickinson and Company) announced a collaboration with Sight Diagnostics Ltd (SightDX), to introduce the 'Parasight' Malaria Detection Platform in India. Through this agreement BD will market the Parasight Platform in the Indian diagnostics market, adding to BD's extensive infectious disease diagnostics portfolio. The collaboration will represent the first malaria diagnostics offering from BD. Varun Khanna, managing director, BD India and South Asia said, "Our collaboration with Sight Diagnostics is aligned with our purpose of advancing the world of health by bringing technology solutions for malaria diagnosis to India. I am confident that this strategic collaboration equips us better than ever before in disease diagnostics and will catalyse BD's role in reducing the global malaria burden." The SightDx Parasight Malaria Detection Platform uses ground-breaking computer vision technology to analyse blood samples for malarial parasites. The technology combines innovative software algorithms, specialized optics, and a new sample preparation method, allowing patient samples to be prepared quickly, easily and reliably. The instrument automatically analyses the sample and provides a diagnostic result within only four minutes. The device also provides information on the species of the infecting malarial parasites and provides information that may be used by clinicians to aid in determining the severity of the illness. The diagnostic information is displayed on the instrument's screen and integrates into the facility's lab information management system. The Parasight Malaria Detection Platform has undergone field testing at a number of Indian and international laboratories, during which it demonstrated a high degree of sensitivity and specificity even at very low levels of infection . Yossi Pollak, CEO of SightDX said, "We are excited that Sight Diagnostics and BD are joining forces in the fight against malaria. Our collaboration with BD provides us with an established and experienced partner in the field of infectious disease, and together we can better serve the Indian healthcare market." The SightDx Parasight Malaria Detection Platform will be BD's first step into the Indian malaria diagnostics market. BD currently markets a wide variety of diagnostic systems in India with numerous offerings in the area of sepsis (blood culture systems), tuberculosis, pathogen identification, and blood cell morphology (flow cytometry systems). Neeraj Raghuvanshi, business director of Diagnostic Systems at BD added, "Working with Sight Diagnostics now gives us the unique opportunity to closely address the clinical needs of improving the quality of malarial diagnosis in India. In partnership with Sight Diagnostics, we would be able to play a definitive role in early and accurate diagnosis of malaria in India which has been long affected by this tropical disease." In 2013, approximately 880,000 cases of malaria were reported in India with over 128 million tests performed . The Parasight Malaria Detection Platform will be marketed in pathology labs and hospitals across India. The technology could also have an application in blood banks, where malaria testing is mandatory on all blood donations. ]]> https://biospectrumindia.com/news/97/6296/bd-biosciences-india-organizes-the-bd-horizon-global-tour.html https://biospectrumindia.com/news/97/6296/bd-biosciences-india-organizes-the-bd-horizon-global-tour.html Fri, 29 Apr 2016 16:03:51 +0530 In continuation of their endeavors towards Flow cytometry training and education, "The BD Horizon Global Tour" was organized by BD Biosciences India. Robert Balderas -VP, Market Development, BD Life Sciences - Biosciences, USA, Aaron Tyznik-Staff Scientist BD Life Sciences - Biosciences, USA and Darren Ellemor - Platform Leader - BD Life Sciences, AP travelled to India as part of the tour. The tour comprised of day long sessions in three cities and was well attended by researchers and students from leading institutions such as Indian Institute of Technology (IIT), All India Institute of Medical Sciences (AIIMS) and National Center for Cell Science (NCCS) to name a few. The Delhi Chapter of the BD Horizon Tour 3.0 was greatly appreciated by customers that included eminent scientists, KOLs, research scholars and scientists from different research institutes across North India. Each of the four segments covered in the program: Design, Analyze, Sort and Discover gave a lot of insights and new information on the subject of multicolour flow cytometry and sorting, which was greatly valued by the audience. Second of the three multi-locational- Horizon Tour events in India was held at National Centre for cell sciences (NCCS), Pune on 20th April, 2016. Researchers and scholars from not only Pune, but also from Mumbai joined. The event started with a welcome note by Dr. Shekhar Mande, (Director, and NCCS) who applauded this initiative of BD and expressed the importance of such programs for research In India. Dr. Lalita Limaye spoke about the long relationship BD and NCCS have had and how BD has always been a part of their institute though the range of flow cytometers at NCCS. She also articulated how BD-NCCS COE had immensely benefited the institute and its researchers since last 5 years. The "HORIZON Tour" talks were led by Dr Robert Balderas, Vice President Market Development, BDB and his team comprising of Aaron Tyznik, Staff Scientist at BD and Darren Ellemor, Platform Leader, APAC. Bob (Robert Balderas) started off with his presentation and explained how to design the best possible panels to answer researcher's experimental questions. Aaron presented how to analyze multiple data sets for maximizing resolution of cell population of interest followed by Darren, who discussed about sorting of highly pure cell population through optimized panel design. Finally Bob went into the details of the future of flow cytometry and the ability to detect up-to 30 and 50 parameters using the new upcoming BD Platforms. The third and the final leg of the BD Horizon India Tour was conducted at the department of biotechnology, Indian Institute of technology-Madras.The show was greatly appreciated by over 180 customers who attended the event. The customers included eminent scientists, KOL's, research scholars and students from different research institutes across Southern India. On Behalf of BD India, Dr.Ranga Partha gave an introduction and an overview of BD and BDB in particular, followed by the technical sessions. The program generated a lot of interest among the student and young researcher's community leading to an overwhelming response. ]]> https://biospectrumindia.com/news/97/6333/bd-introduces-bd-facscelesta-flow-cytometer-.html https://biospectrumindia.com/news/97/6333/bd-introduces-bd-facscelesta-flow-cytometer-.html Fri, 29 Apr 2016 15:46:41 +0530 BD (Becton, Dickinson and Company), a leading global medical technology company, introduced the BD FACSCelesta flow cytometer during the BD Horizons Global Tour 2016. Uniquely designed to leverage the broad BD Horizon Brilliant reagent portfolio, this new system offers simultaneous measurement of up to 14 different single cell characteristics. The BD FACSCelesta is an advanced system for driving scientific insights for a wide range of applications. Available now for research segment use, the BD FACSCelesta is the latest advancement in the award winning BD cell analyzer portfolio. It offers performance that is typically only seen in higher end systems, enabling consistency of results and seamless transfer of applications between BD platforms with 14 parameters in a three-laser benchtop system. For more significant single cell studies and higher quality data, the BD FACSCelesta system opens new avenues of investigation and a deeper level of biological study. When combined with the patented technology of BD Horizon Brilliant polymer dyes, it enables greater resolution of previously unobserved cell populations and is an ideal solution for researchers wanting more fluorophore choices when using multicolor flow cytometry. "Designed from the ground up, the BD FACSCelesta allows researchers to benefit from new innovations in instrument and reagent technology," said Claude Dartiguelongue, worldwide president of BD Biosciences. "This means that researchers can now, with improved brightness and low spectral overlap, optimally identify, characterize, and resolve even dim staining populations of interest." The BD FACSCelesta flow cytometer is available in multiple configurations, delivering the performance required for varied immunology and cell biology applications. The system can help simplify experimental design and analysis for experienced researchers as well as those new to flow cytometry. The four configurations allow the use of 10 or 12 colors. ]]> https://biospectrumindia.com/news/97/8035/abbott-to-acquire-medtech-firm-st-jude-medical-for-25-bn.html https://biospectrumindia.com/news/97/8035/abbott-to-acquire-medtech-firm-st-jude-medical-for-25-bn.html Fri, 29 Apr 2016 11:01:12 +0530 Abbott and St. Jude Medical has announced a definitive agreement for Abbott to acquire St. Jude Medical, creating a premier medical device leader with top positions in high-growth cardiovascular markets, including atrial fibrillation, structural heart and heart failure as well as a leading position in the high-growth neuromodulation market. Under the agreement, St. Jude Medical shareholders will receive $46.75 in cash and 0.8708 shares of Abbott common stock, representing total consideration of approximately $85 per share. At an Abbott stock price of $43.93, this represents a total transaction equity value of $25 billion. The combined company will have an industry-leading pipeline expected to deliver a steady stream of new medical device products across cardiovascular, diabetes, vision and neuromodulation patient care. St. Jude Medical's strong positions in heart failure devices, atrial fibrillation and cardiac rhythm management complement Abbott's leading positions in coronary intervention and transcatheter mitral repair. Together, the company will compete in nearly every area of the cardiovascular market and hold the No. 1 or 2 positions across large and high-growth cardiovascular device markets. This best-in-class combined portfolio will have the depth, breadth and innovation to help patients restore their health, reduce costs for payors and deliver greater value to customers. "Bringing together these two great companies will create a premier medical device business and immediately advance Abbott's strategic and competitive position," said Mr Miles D. White, chairman and chief executive officer, Abbott. "The combined business will have a powerful pipeline ready to deliver next-generation medical technologies and offer improved efficiencies for health care systems around the world."   "This announcement is an exciting next chapter for St. Jude Medical, bringing together two industry leaders with a shared passion for innovation, culture and patients," said Mr Michael T. Rousseau, St. Jude Medical president and chief executive officer. "Our combined scale will expand the global reach, competitiveness and impact of our medical device innovation for physicians and hospitals. This transaction provides our shareholders with immediate value and the opportunity to participate in the significant upside potential of the combined organization. I'd like to thank our 18,000 employees whose hard work and commitment help us deliver leading medical technologies to patients around the world." The acquisition of St. Jude Medical is expected to be accretive to Abbott's adjusted earnings per share in the first full year after closing and increasing thereafter, with approximately 21 cents of accretion in 2017 and 29 cents in 2018. The combination is anticipated to result in annual pre-tax synergies of $500 million by 2020, including both sales and operational benefits. One-time deal-related costs and integration costs will be provided at a future date. St. Jude Medical's net debt of approximately $5.7 billion will be assumed or refinanced by Abbott. Abbott intends to fund the cash portion of this transaction with medium- and long-term debt. The transaction, which has been approved by the boards of directors of St. Jude Medical and Abbott, is subject to the approval of St. Jude Medical shareholders and the satisfaction of customary closing conditions, including specified regulatory approvals. The transaction is expected to close in the fourth quarter of 2016.   ]]> https://biospectrumindia.com/news/97/7656/perkinelmer-gis-open-research-lab-to-advance-precision-oncology-.html https://biospectrumindia.com/news/97/7656/perkinelmer-gis-open-research-lab-to-advance-precision-oncology-.html Thu, 28 Apr 2016 15:46:56 +0530 PerkinElmer and the Genome Institute of Singapore (GIS), a biomedical sciences research institute under Singapore's Agency for Science, Technology and Research (A*STAR), has announced the opening of the PerkinElmer-GIS Centre for Precision Oncology. Leaders from PerkinElmer and GIS attended the official opening ceremony today and discussed objectives for the joint research laboratory. The joint laboratory aims to develop a state-of-the-art high-throughput screening (HTS) platform to predict therapeutic sensitivity in next-generation patient-derived tumor models in real-time, with the ultimate goal of bringing precision oncology research results into the clinic. Specifically, the platform will utilize sequence-informed studies and HTS/HCS focused compound library screens to test the efficacy of different standard of care and pathway-specific inhibitors in 3D tumor micro-spheroid culture models derived either directly from patient primary tumors or patient-derived models (PDX). The collaboration combines PerkinElmer's capabilities in cell-based research imaging technologies with the GIS' expertise in cancer therapeutics and stratified oncology, cancer stem cell biology and adult/embryonic stem cell biology, and regenerative medicine. The resulting research will include high throughput screening to help provide insights related to molecular mutation and aid in the development of biomarkers for patient stratification. "Our collaboration with GIS brings together cutting-edge equipment and services along with insights from some of the world's leading cancer researchers," said Mr Brian Kim, President, Life Sciences & Technology, PerkinElmer. "PerkinElmer's integrated solutions empower researchers to reach greater insights for greater outcomes. Combined with GIS's knowledge and experience, this partnership has the potential to unlock new doors in the future of applying precision medicine to cancer treatment." In the PerkinElmer-GIS Centre for Precision Oncology, GIS provides state-of-the-art patient-derived primary tumor cultures in 3D organoids and tumor microspheroids that mimic tumor architecture and maintain patient-specific genomic, epigenomic, and gene expression signatures. These models can be used for developing next-generation single or combinatorial drug screens and synthetic lethal screens. PerkinElmer complements this effort by providing advanced research technology solutions including: the Operetta High Content Imaging System, Opera Phenix High Content Screening System, the FMT 4000 In Vivo Screening System, the Mantra Quantitative Pathology workstation, and the EnSpire Multimode Plate Reader, in addition to providing technical expertise for advanced high-throughput quantitative imaging and analysis.   Under this collaboration, PerkinElmer and GIS will jointly develop solutions that would integrate genomic sequencing and mutation data, with that of phenotypic data obtained in patient-derived models, as well as patient data in the clinic. These integrated solutions may help further enable translational research in oncology. "This collaboration represents another milestone for GIS which has, over the recent few years, strategically collaborated with industry and clinical partners to spearhead and innovate research techniques in order to prioritize patient care. We are pleased to jointly open a laboratory with PerkinElmer focused on expanding GIS leadership in clinical cancer research and translational medicine," said Professor Ng Huck Hui, executive director, GIS. "On our part, GIS is committed to provide staff, equipment and reagents. We look forward to working closely with PerkinElmer, leveraging our respective strengths, in order to advance precision oncology and bring our research findings directly to patients."   ]]> https://biospectrumindia.com/news/97/8195/nokia-plans-to-acquire-withings-to-accelerate-entry-into-digital-health-.html https://biospectrumindia.com/news/97/8195/nokia-plans-to-acquire-withings-to-accelerate-entry-into-digital-health-.html Thu, 28 Apr 2016 12:41:40 +0530 Nokia has announced plans to acquire Withings S.A., a pioneer and leader in the connected health revolution with a family of award-winning digital health products and services to help people all over the world lead healthier, happier and more productive lives. Withings will be part of our Nokia Technologies business. "We have said consistently that digital health was an area of strategic interest to Nokia, and we are now taking concrete action to tap the opportunity in this large and important market," said Mr Rajeev Suri, president & CEO of Nokia. "With this acquisition, Nokia is strengthening its position in the Internet of Things in a way that leverages the power of our trusted brand, fits with our company purpose of expanding the human possibilities of the connected world, and puts us at the heart of a very large addressable market where we can make a meaningful difference in peoples' lives." World Health Organization figures show cardiovascular disease as today's number one cause of death, with more than a billion adults around the world living with uncontrolled hypertension. Diabetes now affects more than one in twelve adults worldwide, a four-fold increase since 1980. Healthcare is expected to be one of the largest vertical markets in the Internet of Things, with analysts forecasting that mobile health, with a CAGR of 37%, will be the fastest growing health care segment from 2015-2020. "Withings shares our vision for the future of digital health and their products are smart, well designed and already helping people live healthier lives," said Mr Ramzi Haidamus, president of Nokia Technologies. "Combining their award-winning products and talented people with the world-class expertise and innovation of Nokia Technologies uniquely positions us to lead the next wave of innovation in digital health." The combination of innovative products from Withings and the Digital Health business will also ensure the ongoing renewal of Nokia Technologies' world class IPR portfolio.   Withings was founded by Chairman Eric Carreel and CEO Cedric Hutchings in 2008 and is headquartered in France, with approximately 200 employees across its locations in Paris, France, Cambridge, US and Hong Kong. Withings' portfolio of regulated and unregulated products includes activity trackers, weighing scales, thermometers, blood pressure monitors, home and baby monitors and more, and is built on a sophisticated digital health platform, providing insights to empower people to make smarter decisions about the health and wellbeing of themselves and their families. Withings' own products are complemented by an ecosystem of more than a hundred compatible apps. "Since we started Withings, our passion has been in empowering people to track their lifestyle and improve their health and wellbeing," said Mr Cédric Hutchings, CEO of Withings. "We're excited to join Nokia to help bring our vision of connected health to more people around the world." The Nokia brand continues to be recognized, valued and trusted by consumers, built on a heritage of beautifully designed, innovative and reliable technology in the service of people around the world to help real human needs. The planned transaction values Withings at EUR 170 million or ($192.709) and would be settled in cash and is expected to close in early Q3, 2016 subject to regulatory approvals and customary closing conditions.   ]]> https://biospectrumindia.com/news/97/7176/ppd-expands-medical-communications-operations-in-apac.html https://biospectrumindia.com/news/97/7176/ppd-expands-medical-communications-operations-in-apac.html Wed, 27 Apr 2016 11:02:38 +0530 Pharmaceutical Product Development (PPD) has expanded its medical communications services into the Asia-Pacific region, enabling the contract research organization (CRO) to offer its portfolio of multi-lingual contact center services across the globe. By adding to its existing medical communications operations in North America, Latin America and Europe, PPD now is able to extend its services to biopharmaceutical clients in all regions of the world. PPD's Asia-Pacific medical communications operations are managed by teams in Tokyo and Singapore. "Expanding our multi-channel medical communications operations into Asia-Pacific strengthens our ability to provide our clients a single source of global medical information services. That ensures consistency of operations around the world while continuing to deliver high-quality health care services and expertise in an efficient, regulatory-compliant and customer-centric manner," said Ms Vivian Broach, vice president of operations and head of PPD's medical communications operation. "There is strong demand for these services globally, and we have an experienced management team in place to oversee our operations and to create flexible and customized programs that meet our clients' needs at either a global or regional level," she added.     ]]> https://biospectrumindia.com/news/97/8021/dcgi-notification-on-academic-research-will-boost-local-research-iscr.html https://biospectrumindia.com/news/97/8021/dcgi-notification-on-academic-research-will-boost-local-research-iscr.html Wed, 20 Apr 2016 14:08:05 +0530 The Indian Society for Clinical Research (ISCR), the nodal clinical research professional association in India, has said that the recent March 16th Gazette Notification by the Ministry of Health & Family Welfare1 regarding exemption given to academic trials approved by the Ethics Committee for a new indication, new route of administration, new dose or new dosage form of approved drug formulations, would give a much needed boost to institutional research being conducted in India. "Our academic and teaching institutions are engaged in path-breaking research that addresses the unique health challenges of our country," said Dr Shashwati Pramanik, Chair, Regulatory Council, ISCR. "The work they are doing is helping create not just new and better treatment for diseases endemic to our region, but is also making them more affordable and accessible to patients. The recent amendment will significantly reduce start-up timelines due to exemption from DCGI approval while maintaining vigilance through Ethics Committees. Thus, this will give a big fillip to these institutions, encouraging more medical practitioners to get involved in clinical research. A focus on patient safety and Good Clinical Practices must continue to be the guiding principles of such research." Currently, the research being done in India is insufficient to address the country's growing disease burden. India has 16 percent of the world's population, 20 percent of the global disease burden and yet less than 1.4% of global research is being done in India. A greater focus on clinical research is needed in many disease areas where there are unmet medical needs.   Regulatory amendments that encourage research and innovation such as this amendment can pave the way for more breakthrough research. "If we have to tackle India's unmet medical needs, we need to make clinical research work for our country. Academic and investigator-initiated research is an imperative not merely an option in India. We are pleased that the Government has provided certain exemptions to academic research which will further encourage academic research in our country," said Dr C S Pramesh â€?Professor and Chief, Thoracic Surgery, Department of Surgical Oncology at Tata Memorial Hospital. He further added, "Academic research is done to the same stringent local and international guidelines as research done by any sponsor in the country and with equal commitment to patient safety, ethics and quality. We have seen the tremendous benefits that cancer patients at Tata Memorial Hospital have derived from local academic research, both in terms of cost and efficacy and will continue to invest in bringing better and more cost effective treatments to patients."   ]]> https://biospectrumindia.com/news/97/8013/toshiba-gains-fda-approval-for-new-ct-system.html https://biospectrumindia.com/news/97/8013/toshiba-gains-fda-approval-for-new-ct-system.html Wed, 20 Apr 2016 11:03:00 +0530 Providers can now image a wider range of patients with a low cost of ownership as Toshiba America Medical Systems, Inc.'s Aquilion Lightning was FDA cleared with a more powerful 50-kw generator. The Aquilion Lightning meets the business and clinical needs of hospitals looking for a reliable, premium-component, entry-level CT system that maximizes their equipment investment. The Aquilion Lightning is a 16-detector row system designed for routine volumetric scanning. It has a small footprint to allow providers to save on both space and cost, without sacrificing exceptional technology. The system offers the same PUREViSION CT Detector technology that is used in premium Toshiba CT systems and includes AIDR 3D enhanced to help reduce dose and improve patient safety. To simplify complex scans for more consistent imaging, the system comes standard with Adaptive Diagnostic solutions, such as Single Energy Metal Artifact Reduction (SEMARTM) and SURESubtraction. These technologies, along with the industry's thinnest slices, at 0.5 mm, and a 78-cm bore that is the widest in the 16-row detector radiology segment, help optimize workflow and patient comfort.   "Toshiba CT puts customers first by providing top-tier solutions on every scanner, including our entry-level systems with a low cost of ownership," said Mr Dominic Smith, senior director, CT, PET/CT, and MR Business Units, Toshiba. "With numerous features found in our high-end Aquilion scanners, the Aquilion Lightning ensures our customers don't need to compromise quality to meet their business goals."   ]]> https://biospectrumindia.com/news/97/7719/phenomenex-india-celebrates-5-yrs-.html https://biospectrumindia.com/news/97/7719/phenomenex-india-celebrates-5-yrs-.html Mon, 18 Apr 2016 16:00:50 +0530 Phenomenex, founded in 1982 and headquartered in the United States, is a global technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers in pharmaceutical, industrial, clinical research, government and academic labs. With over 700 employees in 16 companies around the world, three manufacturing sites located in the United States, and a network of 60 distributors, the company is able to serve tens of thousands of customers in over 100 countries each year. Phenomenex India, located in Hyderabad, has delighted customers in the local scientific community since 2011. The company houses a specially trained team of technical specialists, operations and marketing support, and a state-of-the-art delivery hub that maintains high stock levels of thousands of products to allow for faster deliveries throughout India. In addition to a collection of award-winning products and technologies, 24/7 live assistance, hands-on training seminars, and a helpful technical support-based website, the team offers a refreshing and personalized customer experience unique to the industry.   As a result, the company has achieved a 98 percent customer satisfaction rate and shown record-breaking growth over the last five years, including a 15 percent growth in 2015 which doubled the industry average. "I am so proud of our team and all of the incredible successes they have earned through hard work and perseverance," Phenomenex's president and CEO Mr Fasha Mahjoor remarks. "I am not surprised in the slightest, as the people who have been an integral part of the company since its beginning are outstanding leaders and team players with palpable camaraderie. This team has truly shown our customers what excellent technology, superior products and unparalleled service and support can be with fanatical attention to detail and a personalized approach to each customer need. The future of Phenomenex India is nothing short of brilliant." ]]> https://biospectrumindia.com/news/97/3135/siemens-thermo-partner-for-molecular-testing-.html https://biospectrumindia.com/news/97/3135/siemens-thermo-partner-for-molecular-testing-.html Mon, 18 Apr 2016 11:54:23 +0530 In a joint effort to provide customers with one of the most advanced solutions for molecular testing, Siemens Healthcare and Thermo Fisher Scientific announce a new strategic relationship that includes the integration of Thermo Fisher Scientific's real-time PCR system into Siemens' VERSANT kPCR Molecular Solution. The combined workflow will offer laboratories Siemens' complete molecular testing solution, which helps ensure leading-edge performance from extraction through detection. Siemens displayed the entire system during the European Congress of Clinical Microbiology and Infectious Disease in Amsterdam, The Netherlands, April 9-12. Thermo Fisher has brought to market easy-to-use, real-time PCR instruments. Designed for mid-throughput, these new systems provide ideal solutions for all users who need a high-performance instrument with features for maximum experiment control. Adding Thermo Fisher's real-time PCR system to the VERSANT kPCR Molecular Solution brings a new level of innovation to the market by providing more flexibility and customization to the molecular laboratory workflow. "Through our molecular diagnostics systems, we offer a total solution for accurate diagnosis and monitoring," says Mr Fernando Beils, Head of Molecular Diagnostics, Siemens Healthcare. "We are excited to strengthen our dedication to molecular laboratory innovations through our partnership with Thermo Fisher Scientific." "This agreement underscores our commitment to work with leading molecular diagnostic organizations that share our vision to develop advanced laboratory solutions," said Mr Drew Burch, Head of Licensing and Commercial Supply for Thermo Fisher Scientific. "We are excited to collaborate with Siemens in support of its VERSANT kPCR Molecular Solution as we work to expand our partnerships in the diagnostics space."       ]]> https://biospectrumindia.com/news/97/8090/lambda-appointed-new-president.html https://biospectrumindia.com/news/97/8090/lambda-appointed-new-president.html Mon, 18 Apr 2016 11:52:56 +0530 Lambda Therapeutic Research announces the joining of Dr Tausif Monif as President - Global Operations. Lambda is a leading Global CRO in the Clinical research domain headquartered in Ahmedabad (India), its global footprint encompasses strategically located offices in Mumbai (India), Poland (Europe), London (UK), USA and Canada (North America) offering End to End Clinical Research and total drug development solutions to Pharmaceutical companies worldwide. Lambda is accreditated by various worldwide Regulatory Authorities like ANVISA-Brazil, EMA, UK-MHRA, POLISH, ANSM (France), TGA-Australia, AGES (Austria), OGYI (Hungary), Turkey MOH,TPS-Canada, USFDA and WHO. Dr Tausif brings with him a rich experience of more than 24 years in the Clinical Research Industry. His joining Lambda will support the company's vision of expanding their Global footprints. He has numerous publications and academic accreditations to his credit and has successfully faced multiple Regulatory Audits across the world in his illustrious career.   "I am pretty confident that his rich experience will help in driving Lambda's growth globally," says Mrs Bindi Chudgar, MD of Lambda Therapeutic Research.   ]]> https://biospectrumindia.com/features/97/8174/hot-start-ups-skilling-the-next-gen-in-biotech-pharma-space.html https://biospectrumindia.com/features/97/8174/hot-start-ups-skilling-the-next-gen-in-biotech-pharma-space.html Thu, 14 Apr 2016 17:39:35 +0530 Hailing from Uttar Pradesh (UP), he says that all his seniors who graduated in Biotechnology actually didn't have any clear-cut idea about their job profiles or the companies in the sector. Everyone told him: 'Bahar (abroad) bahut scope hai, but kahan pata nahi'. This triggered off something within Mr Bhardwaj. He initially planned to start a career counseling portal specifically for Biotech and Pharma students. But it went on to becoming a start-up offering skill development training programs and providing free career counseling. Two years after graduating, he was armed with a couple of years' experience in a Biotech start-up as a corporate relations manager.   It was during his first job at this start-up he was determined to learn all the basic skills needed to build his own start-up in the future. The job offered him extensive learning experience in marketing, operations, financial aspects and overall administration. The young Mr Bhardwaj in 2011 set off on a journey to create his start-up Rapture Biotech, with a vision to offer best-in-class training programs for both academia and corporates in the Biotech and Pharma space. The start-up offers short-term and project training programs for Biotech and Pharma students, while providing skill development trainings for corporate employees. Located in UP, Rapture Biotech's other divisions include Bioteknow and 3S Biosolution.   Bioteknow is a centralized platform where any company or institute can offer their training programs. It also publishes its magazine 'Bioteknow' for Biotech career counseling purposes. 3S Biosolution provides R&D solutions and related services. It supplies, manufactures, and exclusively represents many international brands in India providing bioprocess & R&D solutions, and bioinformatics software for research purposes. The start-up has tie-ups with 40+ international companies for research products sales in India. Its research team is constantly working on developing cheaper research products. It also boasts of 100+ tie-ups with major colleges and universities in India. Similar to other Biotech entrepreneurs, Mr Bhardwaj says that convincing his family about his entrepreneurial decision and arranging for the needed fund to start were two major challenges he faced initially However, through seed funding and his own personal savings he was able to successfully incorporate his dream start-up. "The trends are changing nowadays. Venture capitalists (VC) and clients have started accepting and promoting first generation young entrepreneurs. However, VCs fail to understand start-ups' incubation period, and the technical integration of projects," Mr Bhardwaj comments. The company is expanding its business model through franchise partner program. It has 2 successful franchises in Agra (UP) and Bhopal (MP). It is also coming up with new franchises in Nepal and Andhra Pradesh (AP). Further, the start-up intends to expand internationally to UAE, Sri Lanka and Bangladesh. It currently has an ambitious target of hitting Rs 10 crore in revenues in the next 2 to 3 years. To increase its visibility, the start-up has started offering free career counseling programs, workshops in colleges, and an active social media marketing strategy. From the Government's side, he expects it to enable quick and easy start-up loans, and building Bio-entrepreneurs development centers in the country, and laying emphasis on creating Biotech clusters and Special Economic Zones (SEZs). "In Western countries, the start-up environment is totally different. They promote entrepreneurship at a very early stage in universities itself," Mr Bhardwaj opines. He says that Personal Genomics, Molecular Diagnostics & Instrumentation are happening areas for start-ups. Mr Bhardwaj points that Delhi -NCR Region and Pune are the two start-up hubs because of the presence of major Government laboratories and central government offices enabling favorable technical support and acquiring clients. The entrepreneur highlights patience as the key to be an entrepreneur in the Biotech industry. "Educational background does play a key role in being a bio-entrepreneur. Candidates from abroad universities or IITs do have advantage, especially when it comes to VC funding part," he states, an admirer of Biocon's CMD Dr Kiran Mazumdar. Mr Bhardwaj constantly derives motivation by reading success stories of other entrepreneurs. He enjoys playing mobile games as a way to relax and unwind. "It is better to start now because it is never too early. It is important to self-motivate and believe in oneself. There is no failure in entrepreneurship. It is either a success or a delayed success," Mr Bhardwaj concludes. Entrepreneurial Mistake To Avoid:  Not learning all the sides of a business Hiring wrong people Having smaller margins Start-up Myths To Debunk:  Entrepreneurs are born, not made  In Life Sciences, young entrepreneurs can't sustain business for long Starting a business is easy ]]> https://biospectrumindia.com/news/97/8067/industry-leader-named-to-head-ppds-central-laboratory-.html https://biospectrumindia.com/news/97/8067/industry-leader-named-to-head-ppds-central-laboratory-.html Thu, 14 Apr 2016 11:20:49 +0530 Pharmaceutical Product Development, LLC (PPD) today announced that Mr Hacene Mekerri has joined the global contract research organization (CRO) to serve as vice president of its central laboratory organization. "Hacene has a unique combination of data management and systems expertise, as well as extensive global central laboratory management experience, which make him ideally suited to lead our central laboratory organization," said Dr David Johnston, executive vice president of global laboratory services for PPD. "Hacene's leadership will advance PPD's integration of laboratory and clinical data to meet our customers' research needs." PPD's central laboratory operations are supported by a comprehensive set of data solutions in Preclarus, PPD's award-winning clinical data platform. This capability enables study sites to access clean central lab data in real time, improve inventory management and order tracking, facilitate patient management and safety, and establish complete chain of custody for samples. Mr Mekerri has more than 15 years of management experience in the drug development industry, including with laboratory companies, CROs and pharmaceutical companies. In his most recent posts, he served as managing director for the Asia Pacific region of a large CRO, as well as global director of data management and country head for a global central laboratory focused on late stage clinical trials. His expertise and successful track record have established Mekerri as a recognized industry leader. Mr Mekerri received his bachelor's degree in business management at the Université de Versailles Saint-Quentin-en-Yvelines in France.   ]]> https://biospectrumindia.com/features/97/6059/hot-start-ups-disrupting-indian-cardiac-diagnostics-.html https://biospectrumindia.com/features/97/6059/hot-start-ups-disrupting-indian-cardiac-diagnostics-.html Wed, 13 Apr 2016 17:51:43 +0530 In the Indian clinical landscape, other than large hospitals or specialty centers, the ability to do a proper cardiac diagnosis is mostly absent. "This is the case globally in all emerging markets," reveals Mr Anand Madanagopal, the CEO of CDL. "There is no frontline devices for diagnosing Arrhythmia and Coronary Artery Diseases (CAD) other than Resting Electrocardiogram (ECG) in smaller hospitals." He feels, the 10-second Resting ECG is an inadequate tool to diagnose the above conditions effectively. "Both these conditions require ECG taken during ambulatory mode for comprehensive analysis," he says. With higher number of patients suffering from heart diseases, and the available specialized products in cardiac diagnosis are operable only in tertiary care centers, the reach of precision diagnosis is limited.   Mr Madanagopal points that the whole cardiac care system is tedious and expensive. "Thus, we built a solution that gives the power to cardiologists to do better diagnostics and help take quick decisions based on in-depth, validated information, without the need of being present near the patient, and still be able to run this kind of comprehensive analysis in small and medium hospitals. This will completely change the cardiac diagnostics scenario," he highlights. Currently, no Rhythmanalysis is feasible in smaller hospitals where large number of cardiac patients go in today. Mr Madanagopal emphasizes, "Even when products are available -- like large hospitals -- it is expensive to operate because of the need to run heavy, back-end teams. Post-operative monitoring is also very limited when it comes to smaller hospitals." The start-up has created a first-of-its-kind, advanced cardiac diagnostic products to be used in smaller settings.   "This will enable larger population to be tested in early stages for better management of the disease. Earlier, all diagnostics had to be done strictly at a hospital. Now, technology allows us to perform diagnostics at home," voices Mr Madanagopal. CDL's team consists of 3 founders including Mr Anand Madanagopal the CEO; Mr Praveen L Murthy heads the Hardware and Production; Mr Mosin Badkar as the head of R&D and Engineering; and a fourth team member Mr Ravi B Kaushik, who leads the start-up's Business Development. The team is a mix of experienced professionals including engineers and doctors having vast knowledge in product design and ambulatory ECG analysis. CDL's potential is in instrumentation engineering for clinical application in all the associated areas of R&D. Its key products include MIRCaM 12-Lead multifunction diagnostic platform and its award-winning MIRCaM Diagnostic Patch.   MIRCaM stands for Mobile Intelligent Remote Cardiac Monitoring. The start-up claims that MIRCaM is the only solution in the world to provide comprehensive real-time, 12-Lead ECG diagnostics as cardiac events occur, and from remote locations. Currently, the products are offered as a service on a pay-per-use model. The start-up's area of expertise encompasses R&D, manufacturing, clinical engineering, mathematics and marketing. The plan of action began with the building of prototype and proving its feasibility. This was followed by creating algorithms and building the diagnostics part.   Later, the feasibility of integrating with vendors who already had algorithms were worked upon. This led to the next step of conducting product testing in various hospitals. Lastly, the team built the complete workflow, and launched in to the market. Initially, the start-up met up with challenges unique to its own -- from building the algorithm to understanding the clinical requirements. to getting the right skillsets together. The start-up has invested about US $2,50,000 capital investment, raised through Angel investors and well-wishers. It has already collaborated with leading Universities, silicon manufacturers and healthcare firms. The start-up targets a revenue of Rs 5 crore in the next couple years. All Mr Madanagopal requests the Government to do is to generate an eco-system for testing in Government hospitals, and providing grants for deployment and testing. Mr Madanagopal says that intelligent healthcare will be a prime area for start-ups to look at moving forward. He advocates raising funds from Angel investors from known circles, and as well as customers, as an ideal way to build a Life Sciences start-up. According to him, what kills a start-up? "A bad team will definitely harm any start-up. Irresponsible spending and raising money quickly are other factors," he concludes.   Raining Milestones:  Winner of 'Grand Jury Prize' at StartupIndia Launchpad 2016 by Google Winner of 'Popular Choice and Impact' award at IoTNext 2015 Winner of 'Best IoT Startup 2015' award Winner of 'Walk The Talk' competition at Intel Conference 2015 MIRCaM awarded 'The Most Innovative Product' at IESA Technovation Awards 2014 Major Clients:  Heart & Rhythm Clinic Sri Sri College of Ayurvedic Science and Research Hospital Telerad RxDx Start-up Lessons Learnt:  Being patient Bringing right people on board Good advisory team which is critical, wishes well Talking to the team about vision, journey Handling Start-up Stress:  Engaging with team (apart from mundane work) Ignoring negative energy advise Talking to well-wishers Start-up Myths:  Should be a service-based start-up to generate revenues quickly Should be an aggregator Should have a pedigree Should have a five-year revenue plan Entrepreneurial Mistakes To Avoid:  'Make it all, do it all' attitude Unwisely choosing critical components  Not integrating other vendor components Raising funds early from institutional investors Desirable Qualities In Life Sciences Entrepreneurs:  Ability in understanding medicine and engineering  Bringing all skillsets together Sustaining for longer terms with limited budgets ]]> https://biospectrumindia.com/news/97/6102/freudenberg-gala-launches-high-end-cleaning-trolley.html https://biospectrumindia.com/news/97/6102/freudenberg-gala-launches-high-end-cleaning-trolley.html Wed, 13 Apr 2016 16:46:33 +0530 Freudenberg Gala, a Freudenberg Group company, and a global leader in mechanical cleaning products, has recently launched the high-end Vileda Professional CE 3 Bucket Trolley for cleanroom applications in India. The professional cleaning trolley is designed for major pharmaceutical companies and healthcare providers and hospitals, where controlled environments play a key role in the organization's operations. Controlled environments, such as an intensive care unit in a hospital or production and microbiological areas of a pharmaceutical company, are highly-sanitized due to the nature of the work involved. Any contamination is an expensive proposition for an organization, with significant consequences for people's health, as well as financial implications. Therefore, cleaning in such areas must be consistently meticulous and thorough. The trolley, which is almost equivalent to the price of a small car in India, can be used in all classes of cleanroom such as GMP Classes A, B, C and D, and helps to avoid any cross-contamination. In contrast to trolleys made of brushed stainless steel, the Vileda Professional trolley is electro-polished and therefore avoids contamination by residual matter. This ensures excellent biological control while being easy to clean and fully autoclavable (can work perfectly in pressurized enclosures). The trolley offers ample space for all utensils needed while cleaning effectively. Each trolley can be customized with various buckets, boxes, sieves and bin bags. A MicroControl CE Mop is also provided alongside the trolley which is used to pick up the smallest contaminants of 0.15 microns. The mop is accredited with ISO Class 2 as assessed by the Fraunhofer Institute, Germany. "The product is really evolutionary when it comes to cleaning in controlled environments. The 3 Bucket CE Trolley is a stainless steel trolley, manufactured at Freudenberg Household Products Ox Ab Finland, using the best of processes such as electro-polishing, immersed in an electrolysis tank for 90 hours and requiring limited welding. 90 percent of the trolley is moulded, in contrast to most other trolleys available on the market today," said JMr atin Gala, COO, Freudenberg Gala Household Product Pvt. Ltd.   The trolley is also extremely light, weighing only 7.5 kg, occupies less than half a square meter and is also highly-maneuverable in tight spaces.     ]]> https://biospectrumindia.com/news/97/7660/one-can-play-any-sport-with-cochlear-implants-brett-lee.html https://biospectrumindia.com/news/97/7660/one-can-play-any-sport-with-cochlear-implants-brett-lee.html Tue, 12 Apr 2016 16:48:29 +0530 Australia-based implantable hearing solutions provider Cochlear in 2015 roped in former Australian fast bowler and cricket icon Mr Brett Lee as its global hearing ambassador for its campaign 'Sounds of Cricket', aimed at raising awareness about hearing loss around the world.On April 11, 2016, Mr Lee was in Bangalore addressing the media fellows for this cause. The campaign emphasizes raising awareness of impact of hearing loss at functional, social, emotional and economical levels. Mr Lee had a personal story to tell behind this ambassadorship. "My son had a head injury some time ago, and suffered hearing loss. But it came back naturally," said the ace cricketer. Globally 360 million people suffer from hearing loss ranging from moderate to severe to profound.   About 32 million of these are children under 15 years and 328 million are adults. According to WHO, 60% of hearing loss in children under 15 is preventable. India has 50 lakh patients suffering from severe hearing loss, and 2.35 lakh of them are in Karnataka. Hearing aids is said to only amplify sounds. Cochlear implants, however, stimulate cochlear nerve endings signaling information to the brain. Hearing loss is attributed to infections, birth defects, aging process, head or ear injuries, ototoxic reactions to drugs, and exposure to excessive noise. Can a person with cochlear implants play the game? "Cricket is all about sound.You can play any sport and feel comfortable with cochlear implants. You can get back your normal and productive life. Playing deaf is very difficult, but one can surely play after receiving the implants," voiced Mr Lee. According to Mr Lee, the implant not only enables people to hear but it also builds self-confidence and worthiness in an individual. "There are psychological benefits that goes along with it. Children especially will be able to go to normal schools," he added. He feels that every child in India should mandatorily undergo universal new-born hearing screening. "These screenings regularly happen In Australia and in countries all across the world. India has to implement it soon. This makes early intervention possible and identifying hearing loss at birth," Mr Lee stressed. ENT specialist Dr Shankar Medikeri, who is also the president of Cochlear Implant Group of India (CIG), added similar suggestions. "Hearing evaluations should be mandatorily included in the pediatric vaccination schedule. The tests done for screening are so simple. It would just need equipments worth Rs 2 lakh. Once the tests are done, the results are printed showing whether the individual passed or failed it." Post cochlear implantation, patients are taken through a few months of speech language trainings. Cochlear implants have two parts: One implanted inside the body and the other - a speech processor - worn behind the ear. Implants vary in their features. Price range varies depending on those features. A basic-featured cochlear piece cost Rs 5.5 to 6 lakh. The top-end model having all the features would be about Rs 12 to 12.5 lakh. "Cochlear implantation is cheaper than a kidney transplantation or bypass surgery. It's a one-time, lifetime investment," Dr Medikeri pointed. Large gap exists in receiving cochlear implantations mainly because of cost of the implant, lack of awareness, unavailability of highly specialized medical professionals and surgeons, and feeble initiatives by the State and Central Governments. Initially, NGOs came forward and took initiatives in formulating hearing loss programs. "This was later picked up by various State Governments. Andhra Pradesh led the way followed by Kerala and Tamil Nadu, and also Jharkhand and Madhya Pradesh in the North. Karnataka is still yet to start a program. This should start at primary healthcare centres and done at national level. There are programs happening but are not completely maturing," Dr Medikeri revealed. When BioSpectrum asked if the use of mobile phones cause any damage to the cochlear implants, Chief Audiologist and Speech Language Pathologist Ms Rashmi Deshpande opined, "Mobile phones does not interfere with cochlear implant's functions." Cochlear invests more than AUS $100 million in its R&D annually. "Rather than focusing on the cost, we want the Government to get behind it, and there are individuals who can sponsor or assist in getting implants," Mr Lee highlighted. ]]> https://biospectrumindia.com/news/97/7657/fitastikglobal-healthreach-partner-to-provide-a-comprehensive-corporate-wellness-program.html https://biospectrumindia.com/news/97/7657/fitastikglobal-healthreach-partner-to-provide-a-comprehensive-corporate-wellness-program.html Tue, 12 Apr 2016 12:59:51 +0530 To create a successful wellness program, improve employee participation and increase company productivity, Fitastik, a technology company for healthcare management has tied-up with Global HealthReach, strategic partner of Best Doctors in India, the world's oldest and most reputed second medical opinion provider. The partnership will create a comprehensive corporate health&wellness program as a one stop solution for the entire range of healthcare management services. Users can thus avail easy access to consultation with more than 53000 internationally recognized doctors for second opinion from Best Doctors - InterConsultation for expert opinion & treatment planning advice; Doc-on-Line - online answers from experts, digitization of medical records, health risk assessments, relevant content on better health management and health analytics, among others. Explaining the need for a comprehensive corporate wellness program, Sanjay Lakhotia, Founder and Director, Fitastik, highlighted a recent report that mentions 11-30% average productivity loss stems from employees' concern over personal issues. Talking about the tie-up between Fitastik and Global HealthReach, Mr Sanjay Lakhotia, founder and director, Fitastik said, "Both the companies complement each other in terms of their product offering and target audience. The combined product caters to the need that the customer is increasingly looking for." He further added that the effort is to create a comprehensive health management solution with best in class partnership as medical records give insight into one's health and second medical opinion provides the access to manage one's health issues in moments of crisis. Mr Vikram Anand, founder & CEO, Global HealthReach, said, "Being a comprehensive one stop solution will help customers tremendously, as currently in India, various organizations provide different services and customers need to switch between different providers to avail them. The tie-up also helps both companiesaggressively seize the opportunity in the marketplace."   Rising income and insurance facilities in India along with greater awareness of personal health and hygiene, over the years, has led to a considerable rise in demand for high-quality healthcare facilities and significant increase in expenditure on healthcare. Per capita healthcare expenditure is estimated to have grown at a CAGR of 15.4% during 2008-15 to $88.7 by 2015. The Indian healthcare sector, one of the fastest growing industries is expected to advance at a CAGR of 17% till 2020 to reach $280 Billion. An interesting aspect to be noted is that currently, about 50% of spending on in-patient beds is for lifestyle diseases, increasing the demand for specialized care, preventive healthcare services, and second medical opinion.     ]]> https://biospectrumindia.com/news/97/7554/iscr-invites-patient-participation-in-international-clinical-trials-day-logo-contest-.html https://biospectrumindia.com/news/97/7554/iscr-invites-patient-participation-in-international-clinical-trials-day-logo-contest-.html Tue, 12 Apr 2016 12:45:56 +0530 In an endeavor to reflect the real significance of Patients First, its continuing theme for International Clinical Trials Day, the Indian Society for Clinical Research (ISCR) has announced a logo design contest exclusively for patients. The initiative is a creative way of integrating patients into the commemoration of an important day for the clinical research fraternity and to encourage deeper engagement with patients. Patients are invited to design a logo around the theme Patients First and the winning logo will be used in all communication and creative collateral for International Clinical Trials Day which falls on May 20th. It was on this day in 1747 that Dr James Lind, a Scottish physician, conducted the world's first controlled clinical trial aboard a ship on sailors suffering from scurvy. And like those sailors 268 years ago, several hundreds of thousands of healthy volunteers and patients have since then contributed to the development of new treatments and drugs by participating in clinical trials. The last date for submission of entries is April 25th and more details about the contest are available at info@iscr.org Ms Suneela Thatte, president, ISCR says, "Given the important role that patients plays in clinical research and our mission of enhancing patient outcomes through clinical research, we have decided to continue with Patients First as our theme for International Clinical Trials Day. Through this contest, we want to recognise patients but would also like to solicit their feedback on what clinical research means to them. The logo design contest is one way of incorporating the patient voice in all our communication and thanking them for their contribution to the advancement of medical science through their participation in clinical research."     ]]> https://biospectrumindia.com/news/97/5674/fda-approves-worlds-smallest-pacemaker.html https://biospectrumindia.com/news/97/5674/fda-approves-worlds-smallest-pacemaker.html Thu, 07 Apr 2016 11:54:26 +0530 Medtronic announced it has received US Food and Drug Administration (US FDA) approval of the world's smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart -providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads). Comparable in size to a large vitamin, the Micra TPS is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to such leads and pocket are eliminated-as are any visible signs of the device. The device responds to patients' activity levels by automatically adjusting therapy. Micra TPS is said to be the first and only transcatheter pacing system to be approved for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced imaging diagnostic procedures available. The Micra design incorporates a retrieval feature to enable retrieval when possible; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS was designed with a unique feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction. "Dating back to the development of the first external battery operated pacemaker more than 60 years ago, Medtronic has a long history of collaborating with clinicians to better understand the needs of patients, and then innovating new products to meet those needs," said Dr John Liddicoat, senior vice president, Medtronic, and president of the Cardiac Rhythm and Heart Failure division. "We are thrilled to be the first to introduce a transcatheter pacemaker to patients in the US, and we're looking forward to working with physicians and educating implanters to extend the positive results of our global clinical trial experience to even more patients."   The Micra TPS was awarded CE Mark in April 2015 based on early data from the Medtronic Micra TPS Global Clinical Trial. It is intended for use in patients who need a single-chamber pacemaker. The device was designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink Network; remote monitoring of Micra devices is expected to be available later this year.     ]]> https://biospectrumindia.com/news/97/7275/india-must-be-well-integrated-into-global-diabetes-clinical-research-says-iscr.html https://biospectrumindia.com/news/97/7275/india-must-be-well-integrated-into-global-diabetes-clinical-research-says-iscr.html Wed, 06 Apr 2016 13:08:02 +0530 Recognising the growing prevalence of diabetes particularly in low and middle income countries and its increasing burden on society and the healthcare delivery system, Beat Diabetes is the theme adopted by the WHO for World Health Day which falls on April 7, 2016. It is estimated that by 2030, there will be more than 100 million patients living with diabetes in India. According to WHO's Diabetes Country Profiles, in 2012 there were an estimated 2.2 lakh diabetes related deaths in India. With an increase in life expectancy, obesity and sedentary lifestyles, the prevalence of diabetes will rise dramatically and so will the corresponding number of deaths from diabetes. To effectively combat this chronic disease and its growing burden, there is an urgent need to focus on prevention, early detection and treatment of diabetes. Ms Suneela Thatte, President, ISCR added, "Being labelled as the diabetic capital of the world is not a title for India to be proud of. While there are several treatment options available in the market today to manage diabetes and its associated complications, we need to continue our efforts to find newer and better treatment to treat diabetes and reduce co-morbidities associated with the disease. Diabetes is an enormous public health challenge in India and cuts across all economic strata. We need greater investments in clinical research to find more affordable and accessible treatment options for the increasing number of diabetics in our country. This will reduce the pressure on our overburdened health infrastructure." The WHO estimates that 80 percent of diabetes deaths occur in low and middle income countries. In developed countries, it says, most people with diabetes are above the age of retirement, whereas in developing countries, those most frequently affected are between 35 and 64 years. Further diabetes is a leading cause of blindness, amputation and kidney failure. The ISCR is optimistic that the recent changes by the regulatory authorities in India to create a balanced and scientific environment for the conduct of clinical research in the country will see sponsors increase investments in illnesses that are endemic in the region like diabetes. Beating diabetes requires a collaborative approach which makes people aware of risks, ways to prevent the condition and the need for early diagnosis and treatment.   "While there needs to be increased awareness about diet, physical activity and a healthy lifestyle to combat and prevent diabetes, India needs to be well integrated into the global clinical research efforts underway," added Ms Thatte.     ]]> https://biospectrumindia.com/interviews/97/6147/electronic-wearable-injector-a-reality.html https://biospectrumindia.com/interviews/97/6147/electronic-wearable-injector-a-reality.html Tue, 05 Apr 2016 17:30:00 +0530 West's leadership team comprising Ms Karen Flynn and Mr Warwick Bedwell was recently on a business trip to Hyderabad, India. Ms Flynn is West's SVP & CCO, and oversees the company's new global commercial team that includes marketing, sales and contract manufacturing services, and as well as technical customer support for West's full portfolio of offerings. Mr Bedwell serves as VP & MD for West's Asia-Pacific (APAC) region. Ms Flynn revealed that the company is developing new product offerings in the area of generics, having features that will interest generics companies. "We are inculcating some changes in our commercial strategies to become more oriented to various markets we serve. There is a lot of customer similarities around the world in terms of quality standards and wanting reliable supplies. However, there are uniqueness with respect to customer needs. We align ourselves to the market, and get better understanding of the unique market needs, and bring new products and new services specific to the segments," commented Ms Flynn.   Crucial Indian Market West's key global market segments include biologics, pharmaceuticals and generics. Mr Bedwell added that India is a key market for the company. "India is important for us not just in the APAC region but globally. We have recognized India's advantage. We are here for the last 10 to 15 years. Our plant in Sri City, Chennai, is close to two years old now, and has been highly successful, catering to India and exports," he said. The facility was completed in 2014 with a cost of $15 million to produce seals used in primary packaging of injectable medicines. In terms of volumes, West expects to touch 1.9 billion pieces by 2019-20 at this facility. As a Chief Commercial Officer, Ms Flynn noted that the visibility of needs in India is not as same as in the Western markets. "There is increase in the regulatory enforcements by USFDA. The quality standards are rising here in the local markets. More and more customers are looking to West for primary packaging components that are pre-washed and pre-sterilized," she expressed. Patient Engagement Trends Globally, patients today are increasingly seen to be wanting to manage their health and well-being themselves. "This is enabled through smart devices that can help them to understand what their sugar levels are, for example, along with medication reminders and controlling of medicine intake. This is addressed through our delivery devices which are electronically connected. For this we have partnered with HealthPrize," Ms Flynn stated. This strategic collaboration was announced in September 2015. HealthPrize is a US-based digital health company in patient engagement and medication adherence solutions. The companies intend to integrate HealthPrize's Software-as-a-Service (SaaS) medication adherence and patient-engagement platform with West's injectable drug delivery systems to provide an end-to-end connected health solution for pharmaceutical companies and patients. West's press release pointed that the combined offering will provide voluntary, electronically-connected drug delivery systems that can track when patients take their medications. HealthPrize's system is also said to engage and educate patients to increase medication adherence and medical literacy, rewarding interaction (gaming theory rewarding system), and stick to prescribed treatment plans leading to favorable outcomes. Trend is also catching up in wanting consistent quality products with fewer side effects, treating patients at home and outside of clinical settings, with wearables becoming more important and delivery systems enabling patients to live a normal life. "Efficient use of the medium is a global trend, and producing products that are more efficient. Producing these products encounter higher costs especially in APAC. Products today are made to fit for purpose when it comes to emerging domestic markets," Ms Flynn opined. Mr Bedwell observed that there is more innovation happening with customers in their applications to reduce costs. "There are looking for smaller footprints in manufacturing and flexible manufacturing systems," he remarked. Crystal Zenith In 2015, West came up with its product Daikyo Crystal Zenith (CZ) in collaboration with its Japanese partner Daikyo Seiko. Crystal Zenith is made of Cyclic Olefin Polymer (CoP) containment and delivery system designed as a high-performance alternative to glass. It is said to be more inert than glass, and solves issues dealing with traditional glass as in breakages, delamination, protein aggregation, or certain reactions. At the moment, 22 to 30 companies in India have used Crystal Zenith. Annually, 2% of West's global sales revenues go into its R&D. "All our R&D happens in our centers located in the US, Europe and Singapore," Mr Bedwell told BioSpectrum. First Gen Wearable Injector Ms Flynn mentioned that West is doing a lot of work in the devices space and primary packaging portfolio. "We are getting ready to commercialize an electronic wearable injector this July," she pointed. This is said to be the first generation electronic wearable injector, and its 8 different embodiments are currently under development. The device, according to the company, has been tested on humans and has undergone clinical trials. Globally, today about 2400 drugs are in development at critical stages.West intends to strengthen its understanding in drug products and primary packaging compatibility. "We want to concentrate and focus on the injectable pharma space, and it is a growing market. The market is large. We have more opportunities in this space to expand. We look for technological opportunities and geographical expansion," Ms Flynn shared. In 2014, West Pharma's Pharmaceutical Packaging Systems business recoded revenues of $1 billion. Its Pharmaceutical Delivery Systems business saw $402 million in revenues. (The writer was flown to Hyderabad, India, by West Pharma to meet its leadership team) ]]> https://biospectrumindia.com/news/97/6330/ibm-plans-first-watson-health-european-center-of-excellence-in-italy.html https://biospectrumindia.com/news/97/6330/ibm-plans-first-watson-health-european-center-of-excellence-in-italy.html Tue, 05 Apr 2016 11:39:00 +0530 IBM has announced plans to launch its first Watson Health European Center of Excellence in Milan near the Human Technopole Italy 2040 research campus, supporting the government of Italy's initiative to establish an international hub for the advancement of genomics, big data, aging, and nutrition. The Center is part of a long-term collaboration between IBM and the government of Italy. IBM plans to invest up to $150 million (€135 million) over the next several years and bring together Watson Health data scientists, engineers, researchers and designers to develop a new generation of data-driven healthcare applications and solutions. Further, the formation of the Center is intended to encourage the development of a pan-European ecosystem for healthcare reform, research, and health-tech start-ups. IBM data scientists, engineers and programmers are expected to work in collaboration with organizations across Europe to create a new class of cloud-based connected solutions at the intersection of cognitive computing, life sciences and healthcare. The Center is expected to provide access to resources and technology designed to help accelerate research into new treatment options, promote personalized medicine, and encourage discoveries aimed at improving overall public health management while advancing sustainable health systems. "Italy is important to IBM - not only because of the creativity, skills and talent of the country's workforce, but also because of the Government's efforts to digitize Italy's economy," said Mr Erich Clementi, senior vice president, IBM Europe. "That is why we are excited to announce our new Watson Health European Center of Excellence near Milan, which will support the Italian Government's healthcare reform and research agenda by bringing together Watson developers and IBM Research scientists to apply remarkable cognitive computing capabilities to modern healthcare problems." The plans for the first European Center of Excellence underscore IBM's continued investment in Watson Health, a global business unit founded in 2015. Watson Health brings the advanced cognitive computing capabilities of IBM Watson to doctors and other healthcare professionals.   IBM anticipates that the Center will tap into the Watson Health Cloud and other offerings, which are designed to help enable individualized insights and a more complete picture of the many factors that can affect people's health. The Watson Health cloud platform allows this information to be anonymized, shared, and combined with an aggregated view of other health data to, for example, improve the ability of doctors and medical researchers to identify unexpected new drug targets or enable doctors to personalize treatment options for cancer patients. "Healthcare is undergoing tremendous change, driven by data. The volume and variation of health data is growing exponentially with each passing day and our ability to monitor new measurements of health - such as social data and weather data - are making global health an even more complex equation to solve," said Ms Deborah DiSanzo, general manager for IBM Watson Health. "This new era in health will not be achieved through solitary efforts. It will require the work of countless experts together in an ecosystem where ideas are easily shared to improve and save lives around the world." The Watson Health European Center of Excellence builds on IBM's recent investments in Italy and across Europe, including a new IBM Cloud data center in Milan, hiring young Italian workers while strengthening partnerships with key universities and start-ups, and the opening of the Watson IoT Global Headquarters in Munich, Germany.     ]]> https://biospectrumindia.com/news/97/7582/ppd-named-best-cro-at-vie-awards-.html https://biospectrumindia.com/news/97/7582/ppd-named-best-cro-at-vie-awards-.html Tue, 05 Apr 2016 11:08:21 +0530 Pharmaceutical Product Development (PPD) has announced it was named the Best Contract Research Organization (CRO) at the 9th Vaccine Industry Excellence Awards at the World Vaccine Congress 2016. The ViE awards celebrate the outstanding achievements of leaders who continually set standards of excellence and advocacy in the vaccine industry. "We are honored to receive this award acknowledging PPD's contributions in helping our customers bring life-changing vaccines to patients more quickly and with the highest standards of quality," said Mr Bill Sharbaugh, PPD's chief operating officer. "PPD has more than 25 years of experience in providing a full range of vaccine testing services. This honor recognizes the expertise of our dedicated team members, who are experts and thought leaders in their individual disciplines and involved in establishing best practices for national and international regulatory organizations." PPD's service offerings span the value chain of clinical research, with integrated Phase I-IV services and PPD Laboratories, offering the most comprehensive lab services available in the industry. PPD Laboratories' vaccines sciences lab has worked on 12 vaccines approved by regulators and is a leader in comprehensive development and testing services of vaccines. With state-of-the-art facilities and instrumentation, PPD's vaccine sciences lab helps customers realize the highest scientific standards for their programs, with a focus on cost efficiencies to speed the introduction of life-changing vaccines. The World Vaccine Congress is an annual gathering of the global vaccine industry to discuss commercial and scientific issues involving regulation, strategy, manufacturing, trials, partnering, influenza, cancer, emerging diseases and veterinary vaccines.   ]]> https://biospectrumindia.com/news/97/8123/fujifilm-nm-medical-launches-3d-mammography-machine-.html https://biospectrumindia.com/news/97/8123/fujifilm-nm-medical-launches-3d-mammography-machine-.html Mon, 04 Apr 2016 16:17:55 +0530 Fujifilm India and NM Medical has announced tie up for the installation of Fujifilm's state of the art Amulet Innovality - a highly advanced breast cancer diagnostic machine for early detection of breast cancer in women. The Amulet Innovality provides 50 Micron 3D image quality and advanced tomosynthesis technology that reveals the internal structure of the breast with a precision that enables the detection of those lesions that ordinarily get overlooked in a routine mammography. The installation of the Amulet Innovality at NM Medical Center will give the women access to early detection of Breast Cancer. The Amulet Innovality uses advanced tomosynthesis technology to enable the conversion of digital breast images into a 3-D reconstruction of the breast, in contrast to the flat images produced by traditional 2-D digital mammography. Reconstructed tomographic images reveal the internal structure of the breast, simplifying the detection of lesions that may be overlooked in a routine mammography. Amulet Innovality enables diagnosticians to obtain a clearer view of the breast tissue, facilitating identification of early stage breast cancer and reducing the need for additional tests and biopsies. Commenting on the occasion Mr Yasunobu Nishiyama, managing director, Fujifilm India said, "It is a known fact that late diagnosis results in slimming the chances of survival. It is therefore vital for healthcare providers to step up and provide women the best early detection screening facilities that can help save lives. At Fujifilm, we are continuously innovating, creating new technologies, product and services and the Amulet Innovality is one such product that has made early detection of breast cancer a reality for women all over the world."   "The installation of the Amulet Innovality at NM Medical is another step for us in line with our commitment to raise awareness and promote early detection and treatment of breast cancer in India. We are grateful to our partner, NM Medical for joining hands with us in this endeavor," said Mr Chander Shekhar Sibal, executive vice president and head of Medical Division at Fujifilm India. "We have always endeavored to provide the very best of technology across our centres and 3D Digital Mammography is another step in that direction. It is expected to be a game changer for early detection of breast cancer in Mumbai," said Dr Nilesh Shah, chairman and managing director, NM Medical. Several features of Amulet Innovality offer women a safe and personalised screening experience, making it easier for them to come for breast examinations. This unique system caters to the unique biological makeup of every woman: The Intelligent Automatic Exposure Control (i-AEC) defines the optimum X ray dosage for each breast type, compared to conventional AEC where the sensor position is fixed. A direct conversion flat panel detector with a 50 micron pixel resolution, and other advanced technological features also give this system a distinct edge over others. 50 micron resolution is best resolution and it helps detects cancer at a very early stage.     ]]> https://biospectrumindia.com/news/97/8330/healthcare-sector-to-reach-over-280-bn-by-2025-nathealth-.html https://biospectrumindia.com/news/97/8330/healthcare-sector-to-reach-over-280-bn-by-2025-nathealth-.html Mon, 04 Apr 2016 10:48:22 +0530 NATHEALTH, Healthcare Federation of India, an apex body for the healthcare sector partnered with Deloitte to present imperatives and develop recommendations for actualizing 'Make in India' for the medical devices industry and released 'Code of Ethics' in collaboration with Indian Medical Association (IMA). "The healthcare sector is expected to reach $145 billion by 2018 and over $280 billion by 2025. Though India's healthcare sector has evolved significantly in the last decade, challenges exist in providing access to quality healthcare in the country," said Mr Anjan Bose, secretary general, NATHEALTH. "Lower financing and expenditure on healthcare, inadequate healthcare infrastructure and dual diseases burden are key challenges faced by the sector," added Mr Bose. Medical technology cost in setting up a tertiary care hospital amounts to 30-40 percent. Cost of medical technology/equipment/devices is 20-25 percent of total healthcare cost for a patient. "Given the increasing demand for healthcare and the critical role of medical devices in providing affordable and accessible health, the time is right to align the eco system to view medical devices as a strategic driver. The 'Make in India' initiative is the perfect opportunity to create a step change in Indian healthcare and especially in the medical devices industry," said Ms Charu Sehgal, partner and Life Sciences and Healthcare Leader, Deloitte India.   The medical devices market is estimated to grow organically at 15 percent to $8.6 billion by 2020. Though the current domestic medical devices market represents only 1 percent of the global market, India is among the top 20 in the world and among the top 4 in Asia (after China, Japan, South Korea). The medical devices market has grown at 10 percent in the past decade and is expected to have an organic growth of 15 percent in the medium-term against global industry growth of 4 - 5 percent," informed Mr Sushobhan Dasgupta, president, NATHEALTH. Industry estimates that India's medical devices market has the potential to become $50 billion industry by 2025 when the contribution of India to the incremental medical devices industry growth would become substantial at 31 percent. While export of medical devices has been increasing, 'local innovation' by MNCs and domestic manufacturers is expected to drive growth. Medical devices exports have been growing at a CAGR of 12 percent which indicates a promising domestic manufacturing industry, added Mr Dasgupta. As the demand for medical devices increases, India is expected to contribute significantly to the growth of global medical devices industry. MNCs like General Electric, Philips, Medtronic, Siemens etc. have been increasing their manufacturing footprint and research centers in India both for Indian market as well as for exports. Newer markets are opening up due to India-based innovation. USA, Africa, Middle East, China and South East Asia are a few key export destinations from India. India presents a good opportunity for companies to de-risk their business from dependency on one manufacturing location and tap potentially huge domestic market at the same time.   Given the criticality of medical devices for growth of the healthcare sector and challenges faced in medical devices manufacturing, it is imperative for the stakeholders in the medical devices and the larger healthcare ecosystem to constructively engage with the Government to facilitate 'Make in India' for the medical devices industry, emphasized Mr Bose. The Government can shape the growth of indigenous manufacturing in its role as a policymaker, development agency and buyer of medical devices. NATHEALTH-Deloitte recommends incentivize medical devices manufacturing - Provide CENVAT/Duty credit on raw materials of medical devices, enable concession duty, VAT parity with imported equipment; facilitate FDA or FDA equivalent certifications for ensuring quality. NATHEALTH asks for separate regulations for medical devices and stresses on state specific incentivization for manufacturing. Trust deficit and unethical practices being a major issue of healthcare industry, NATHEALTH has also developed 'Code of Ethics' in collaboration with Indian Medical Association (IMA) which was released at the event. Ms Preetha Reddy, vice chairperson, Apollo Hospitals and the Champion of the Code of Ethics Initiative at NATHEALH said, "Over the last few decades, our country has witnessed a revolution in medicine. There is a much greater understanding of diagnosis and treatment of diseases, medical care has become lot more accessible and affordable, technology is changing the care paradigm, innumerable lives have been saved, and the noteworthy aspect is that at the core of all this positive progress is the resolute commitment to provide superlative patient care. The private sector has worked with the government to bring in quality standards in the country and now the time is right to bring in a change in the way the private healthcare sector is being perceived. This initiative, a voluntary Code of Ethics initiated by NATHEALTH, a model of self-regulation resonates with this valued goal and it speaks of intent for continuous improvement." Dr KK Aggarwal, Honorary secretary general, IMA explained, "The Code is intended to provide guidance to the members with regards to their conduct and interactions with patients/end users, and other stakeholders so as to ensure that their daily activities, efforts and interactions are undertaken in an ethical, honest manner within the parameters of law for the advancement of healthcare and improved patient care in India."   ]]> https://biospectrumindia.com/news/97/7352/portea-medical-acquires-health-mantra.html https://biospectrumindia.com/news/97/7352/portea-medical-acquires-health-mantra.html Fri, 01 Apr 2016 11:35:02 +0530 Portea Medical, a premier home healthcare company has announced that it has acquired home medical equipment service provider, Health Mantra India Private Limited. The acquisition, which was made for an undisclosed consideration of cash and stock, expands Portea's penetration into large home healthcare areas such as sleep medicine, respiratory care, geriatric care and orthopaedics. Health Mantra was started in 2009 in Bengaluru by Mr Ashish Bhutada and Mr Anoop Kodoli. The company has a team of 30+ biomedical engineers, physiotherapists and service staff and a service network across five states - Karnataka, Kerala, Tamil Nadu, Andhra Pradesh/Telangana and Maharashtra. Commenting on the acquisition, Dr Meena Ganesh, MD and CEO of Portea, said, "Portea is deeply committed to providing our patients with convenient and affordable solutions for all their healthcare needs. Medical equipment is often an integral element of effective home healthcare especially in areas such as diabetes, oncology, orthopaedics, geriatric care, sleep and respiratory disorders. Our acquisition of Health Mantra augments Portea's offering and underlines our customer focus. "The Health Mantra team has built a very solid business over the last few years and we are pleased to have the opportunity to tap into their expertise and customer relationships," she added. Mr Ashish Bhutada, co-founder, CEO and managing director of Heath Mantra, said, "Our alignment with Portea provides us a wider canvas to expand our operations across product lines and locations. We are already present across South India and Maharashtra; there is huge untapped demand in these markets as well as elsewhere in the country and we look forward to continuing to serve customers with patient-centric and holistic solutions".   ]]> https://biospectrumindia.com/news/97/8075/medtronic-launches-treatment-for-overactive-bladder-.html https://biospectrumindia.com/news/97/8075/medtronic-launches-treatment-for-overactive-bladder-.html Thu, 31 Mar 2016 12:06:53 +0530 Medtronic has announced the launch of its NURO System that delivers percutaneous tibial neuromodulation (PTNM) for the treatment of overactive bladder (OAB) with symptoms of urinary urgency, urinary frequency, and urge incontinence. PTNM, a minimally invasive, periodic, office-based procedure, provides a measurable reduction in urinary frequency and/or urinary incontinence episodes following treatment without the side effects of medication. The NURO System delivers a gentle electrical pulse to the tibial nerve via an acupuncture-like needle placed in the skin near the ankle that is attached to a neurostimulator. The therapy is administered in physician offices during weekly 30-minute sessions for 12 weeks and thereafter as prescribed by a physician. Patients are free to read or listen to music while therapy is administered. The most common side effects are temporary and include mild pain or skin inflammation at or near the stimulation site. Evidence points to OAB being caused by a miscommunication between the bladder and brain. Medtronic Bladder Control Therapies use neuromodulation, or gentle nerve stimulation, to reset the brain-bladder communication pathway. PTNM is thought to improve bladder function by targeting the tibial nerve, indirectly activating the central nervous system to help alleviate symptoms. In clinical trials PTNM significantly decreased the number of incontinence episodes and voids per day, reduced the number of urgency and urge incontinence episodes and increased voiding volume. With maintenance therapy, PTNM can offer long-term relief. "So many suffer from OAB and the majority are either not treated or not finding relief with other treatments, so Medtronic is pleased to offer another option along the care pathway," said Ms Linnea Burman, vice president and general manager, gastro/urology therapies at Medtronic. "Our hope is that our expanding neuromodulation portfolio can help a broader range of patients get their lives back."       ]]> https://biospectrumindia.com/news/97/7899/smith-nephew-makes-strategic-investment-in-surgical-robotics-with-acquisition-of-blue-belt-technologies.html https://biospectrumindia.com/news/97/7899/smith-nephew-makes-strategic-investment-in-surgical-robotics-with-acquisition-of-blue-belt-technologies.html Tue, 29 Mar 2016 12:36:48 +0530 Smith & Nephew, the global medical technology business, has recently completed the acquisition of Blue Belt Holdings, Inc., securing a leading position in the fast-growing area of orthopaedic robotics-assisted surgery. With this acquisition, Smith & Nephew will introduce Blue Belt Technologies' NAVIO surgical system to India for the first time. The NAVIO surgical system currently provides robotics-assistance in unicondylar or partial knee replacement surgery through CT-free navigation software and a unique hand-held, robotic bone-shaping device. The combination of Blue Belt Technologies with Smith & Nephew's Knee Implant franchise creates a strong combined partial knee portfolio to accelerate growth in the attractive area of partial knee replacement surgery. Commenting on the same, Mr. Badhri Iyengar, Managing Director - India, Smith & Nephew Healthcare said, "We are committed to bring in the best technologies to improve people's lives across the globe. With our recent partnership with Blue Belt Technologies, we aim to offer high degree accuracy in placing implants with the help of Navio technology. With ease of use and attractive economics, Navio will redefine robotics in orthopaedic surgery." Smith & Nephew intends to expand the NAVIO platform into total knee, bi-cruciate retaining knee and revision knee implants, delivering significant further upside. ]]> https://biospectrumindia.com/features/97/8482/hot-start-ups-anatomizing-3d-printing.html https://biospectrumindia.com/features/97/8482/hot-start-ups-anatomizing-3d-printing.html Thu, 24 Mar 2016 16:58:00 +0530 The Fantastic Four Anatomiz3D's founding team consists of a dynamic team in their 20's including, Mr Sohrab Kothari (28), Mr Sagar Shah (28), Mr Samkit Shah (28), and co-founder Ms Firoza Kothari (23). In 2012, the founders together co-founded another start-up - Sahas Softech - which offers a range of rapid prototyping and 3D printing solutions. Equipped with profound experience in 3D printing, CAD, CAM and allied services, the team ventured into their brand new start-up this year. Firoza is a Biotechnology engineer while the rest of them are MBA graduates.   "We were on the look out to start something," says Firoza, "where we can contribute and not just distribute, and with other co-founders already having a broad idea about the operations along with the promise 3D printing holds for the future, we believed that this is a space where we can not only learn and explore, but if we use our strengths well, we could also contribute to this technology and industry." The team first tried to learn the processes and procedures involved along with its detailed scope in the healthcare segment. "We assessed our current strengths and abilities to prioritize our target segment. Once we started gaining more in-depth knowledge, we started reviewing our plans and made alterations to our goals as we got a better insight from the customers, medical community, researchers and current market operators," adds Sagar. World Of 3D Printing Apart from prosthetics, Anatomiz3D has done a lot of focused work in 3D-printed pre-operative surgical and educational models.   Explains Sohrab, "We take the patient's CT or MRI scan and design a 3D model right out of the patient's anatomy. These 3D-printed models assist doctors in planning their entire surgery before even entering the operation theatre. It helps them understand the exact anatomical relationships by replicating the structural conditions." This allows selecting the best surgical plan, and medical teams feel more prepared and confident, saves operating time, reduce blood loss and anesthesia time, and aids faster recovery, leading in the reduction of overall operational costs. The start-up is also exploring sections of 3D-printed custom implants and surgical guides. "We can design a patient-specific implant based on his or her exact anatomy, and print them directly in titanium 3D printers with custom meshes that can allow bone regrowth -- a procedure that is very difficult to achieve with traditional manufacturing. Surgical guides make the surgical procedure easier for doctors as cuts and drills are pre-planned," comments Samkit. One of its product categories also includes custom braces and splints for fracture rehabilitation.   Based on a patient's scan, the start-up is able to design a custom fit orthotic, which is not only light weight but also allows air to pass. "It can be personalized to look however a person needs. So, one can express their individuality while recovering from their trauma. Who said injuries can't be fashionable!" exclaims Firoza. Anaztomiz3D's team feels that the possibilities with the 3D printing technology are endless. "There is a hope that we will one day be able to 3D print organs in a lab out of a patient's cells itself, thereby reducing the need for organ donors, and the possibility of organ rejections after transplantation," points Sagar. New Industry, New Challenges   The 3D bioprinting being a new space in India, the challenges faced by the start-up bore witness to the current market scenario. The start-up says that it is still an uphill task to convince medical practitioners and patients to try their services. "The cost has to be borne by the customers without having a cover for insurance on such products, and is a pressing issue even today as not everyone can afford it despite it having a high chance of improving decision-making and planning - whether before, during and after a surgery or the required procedures," observes Samkit. Since the team was already successfully running their other start-up which already had the required equipments for Anatomiz3D's works, a lot of capital was saved which otherwise would have needed large investments in diverse machines. Firoza states, "A lot of the funds were obtained from Sahas' internal accruals, and by simultaneously sharing office space and resources, we managed to mitigate investments as and when required."   The start-up did approach venture capitalists at some point. "With a couple of inputs from them, we are back to the planning and delivery mode where we are investing our time in understanding the nuances, differentiation and review our set of priorities which we feel requires some alteration. Also, with the amount of momentum we have achieved, we have started receiving offers from interested parties and are trying to find common goals and objectives to be able to optimally penetrate the length and breadth," mentions Samkit. Laser Focus The team admits that the start-up is not bound by any revenue targets. Sohrab validates, "This being an extremely new industry with very few concentrated players, it is of paramount importance for us to educate about all the scope of the work.... We are looking to engage with people from all verticals who are keen to learn the benefits, and at the same time experiment with any new possible ideas."   The West having witnessed a couple of cycles from the dot-com to the internet of things (IoT), their ecosystem is said to have a certain level of maturity, benchmarking, fine-tuning and exit plans churned out, and have had a number of ups and downs to further its ecosystem. "...but the eco-system in India, despite having a back-up or a benchmark based on the Western system, is yet to evolve as far as entrepreneur engagement, planning, and delivery are taken into consideration," shares Sagar. Firoza emphasizes that starting up in the healthcare industry requires utmost attention. "This is not a place where we can compromise on the quality of services we provide. It can result in a life or death situation for a person. Hence, as important as it is to make a flourishing and profitable business, it is also important to keep in mind why we ventured into this industry in the first place. If you provide brilliant quality services with a clean heart and mind, success will follow. It will also bring along with it a wave of respect and appreciation for your work from the industry, and that feeling is beyond replaceable," she concludes. Milestones    First to handle pediatric cardiology cases in India Executed partial amputee prosthetic hand case First in country to provide pre-op models for soft tissue anatomy like cardiovascular, pulmonology & nephrology Entrepreneurial Mistakes To Avoid  Failing to learn actual scenarios More strategizing than getting one's feet dirty  Not laying core foundations (values, philosophy) Pricing Valuation How A Prosthetic Hand Is 3D-Printed  Scanning a patient's hand or POP casted model Modifying the prosthetic based on patient's scan using exact measurements.  3D printing the parts Assembling the parts ]]> https://biospectrumindia.com/features/97/6691/hot-start-ups-the-3d-future-is-here.html https://biospectrumindia.com/features/97/6691/hot-start-ups-the-3d-future-is-here.html Tue, 22 Mar 2016 11:00:24 +0530 Six years ago Mr Deepak Raj (44) experienced an entrepreneurial spark in his heart and desired to explore things on his own. The result was the formation of Osteo3d, a start-up focusing on 3D printing for healthcare, offering customized solutions for healthcare applications by providing medical models for surgical planning and surgical guides using 3D printing technology. A medical model is said to be a 3-dimensional representation of a part of the human body. Thus, a 3D-printed medical model is a physical entity created from a digital medical image using 3D printing technology. This model is used by healthcare professionals for surgical planning and reconstruction.   With this technology, surgical procedures can be conducted offline to validate implants and processes. "This will help in the reduction of the duration of the actual surgical procedure, and result in better efficiency and accuracy," says the start-up. Customized surgical guides are used for special surgical procedures. Here, 3D printing enables the making of specialized surgical guides needed for special procedures. Mr Deepak is also the founder of another start-up based on 3D printing technology - df3d - known as design factory for 3D printing. df3d offers cloud-based platforms for designs and software in the area of 3d printing.   df3d helps starting a retail or online 3D printing business by providing them with end-to-end consultancy, support, software and design platforms to enable businesses. Finding customers and sourcing funds were initially challenging for the young start-up. Mr Deepak managed to self-fund Osteo3d along with a grant from the Department of Biotechnology (DBT). Revenues generated so far from customers is enabling Osteo3d to run its operations. "Running behind investors, forgetting customers and not generating enough revenues will kill a start-up," he points.   Commenting on start-up trends, whether in the West or the East, Mr Deepak says, "There is a lot of hype in our world about start-ups. Today, it is a planet of the Apps, isn't it?" With a rich 22 years of industry experience, he advises all the budding entrepreneurs to focus on executing plans and solutions that customers will be willing to pay for. "Create a business model where customer revenues drive growth. Establish an entity in such a way that you do not have to run behind investors. If they knock on your door, check them out," opines Mr Deepak. Well, does running two start-ups simultaneously doesn't make him stressed? "Ha! What is that? Stress is fun," he replies instantly. In his spare time, Mr Deepak adds that he cherishes photography and exercises his culinary skills.   He holds a Bachelor's degree in Electronics and Communication Engineering from Mangalore University, Karnataka. Mr Deepak lists hard work, being frugal, perseverance and persistence as top indispensable qualities for being an entrepreneur in any industry. He also shares that being an entrepreneur is a lot of hard work and not living a 'fancy life' as propagated mythically. "There is no such thing as being your own boss or being independent while you are an entrepreneur. You have enough stakeholders who are thousand times worse than your ex-boss," notes Mr Deepak. ]]> https://biospectrumindia.com/news/97/8127/thermo-fisher-scientific-offers-euroimmun-anti-zika-virus-test-kits-.html https://biospectrumindia.com/news/97/8127/thermo-fisher-scientific-offers-euroimmun-anti-zika-virus-test-kits-.html Wed, 16 Mar 2016 12:22:03 +0530 Thermo Fisher Scientific Inc., is now offering the first test kits available in the U.S. to enable serological detection of the Zika virus in research applications. The kits, manufactured by EUROIMMUN AG, can differentiate between Zika, dengue and chikungunya viruses. These tests also enable researchers to detect the virus in samples over a much longer period of time than is possible with current direct-detection assays. The EUROIMMUN Anti-Zika Virus ELISA and indirect immunofluorescence (IFA) test formats allow researchers to detect specific antibodies (IgM and IgG) in blood samples. The highly specific viral antigen used in the assays virtually eliminates cross reactivity with other flavivirus antibodies that are known to interact with the Zika virus, enabling reliable differentiation from viruses such as dengue fever. The EUROIMMUN antibody detection test kits can be run on fully automated analyzers, allowing researchers to work with large volumes of samples to better understand the virus. "Since first learning about the Zika outbreak, we've worked closely with our colleagues at EUROIMMUN to mobilize resources and address this urgent need," said Mark Zacur, vice president and general manager of Thermo Fisher's healthcare market channel. "The EUROIMMUN test kits are an important step forward in the ongoing Zika response by facilitating a better understanding of the virus. We are pleased to have been chosen as their exclusive channel for making these tests available to our clinical research customers across the U.S." Hamid Erfanian, chief executive officer of EUROIMMUN US, commented, "We are excited to be partnering with Thermo Fisher to quickly put our tests in the hands of more clinical research customers through their extensive U.S. network." The EUROIMMUN Anti-Zika Virus ELISA and IFA test kits are available immediately through the Fisher HealthCare channel. ]]> https://biospectrumindia.com/news/97/7333/charles-koontz-appointed-president-and-ceo-of-ge-healthcare-it-.html https://biospectrumindia.com/news/97/7333/charles-koontz-appointed-president-and-ceo-of-ge-healthcare-it-.html Wed, 16 Mar 2016 12:02:11 +0530 GE Healthcare has announced the appointment of Mr Charles Koontz as president and CEO of GE Healthcare IT and GE Healthcare chief digital officer, effective March 14. Mr Koontz succeeds Mr Jan De Witte, who is leaving GE. Mr Koontz joins GE from Computer Sciences Corp (CSC) and CSRA, where he was executive vice president of the Federal Civilian Agencies Group. As VP and general manager of the Healthcare group at CSC, Charles focused on transitioning healthcare clients to next generation IT, mobile and cloud technology, and applying real-time analytics to measure clinical and performance outcomes. Prior to this, Mr Koontz led the health practice at Booz Hamilton, where he built a health analytics business working with Fortune 500 healthcare companies and government organizations. His 30-year tenure in technology innovation also includes leadership roles with SAIC, Capgemini and Ernst & Young. He holds a bachelor of science degree in engineering from The Ohio State University.   ]]> https://biospectrumindia.com/news/97/7971/indian-certification-of-medical-devices-scheme-launched.html https://biospectrumindia.com/news/97/7971/indian-certification-of-medical-devices-scheme-launched.html Wed, 16 Mar 2016 12:01:42 +0530 Indian Certification of Medical Devices Scheme (ICMED)" - country's first indigenous quality assurance system for India manufactured medical devices was launched in the presence of top representatives from government, healthcare industry and quality council fraternity. ICMED - the first home developed international class certification scheme for the medical devices in the country - is an initiative of Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). ICMED is aimed at enhancing patient safety, to provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers and users. This Scheme is intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market. For manufacturers, it aims to bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies and eliminate the malpractices of sub-standard or fraudulent certification or quality audits, thereby ensuring substantial savings, enhanced credibility and increased competitiveness. As currently, there is no India-specific official quality assurance system, due to which Indian medical device manufacturer's encountered loss of competitiveness to foreign companies while consumers ended up paying extra premium with no concomitant benefits, ICMED also fills a big regulatory void. "The scheme fills a big regulatory vacuum in quality certification space for medical devices in the country and will enhance the competitiveness and profitability of Indian medical device industry," said Dr V K Subburaj, secretary, Dept of Pharmaceuticals, GoI while launching the scheme.   AIMED has termed it a significant milestone due to multiple benefits it would assure to different stakeholders. "The Scheme is a significant milestone for both consumers as well as manufacturers as it brings quality, accountability and competitiveness in the system," said Mr Rajiv Nath, forum coordinator, AIMED and chairman, Technical Committee, QCI-AIMED Voluntary Initiative on Medical Devices. The Certification Scheme being launched has presently two options for certification, one being 'ICMED 9000 Certification (an ISO 9001 plus additional requirements)' and other being 'ICMED 13485 (An ISO 13485 Plus additional requirements). A third level, which would additionally prescribe medical device specifications developed by NHSRC of the Ministry of Health and Family Welfare is still under development and would be launched later. "QCI is happy to lend a helping hand to the medical device industry in India to showcase its strength in terms of meeting the highest international standards. We have already devised such schemes for ayurvedic products, ready mix concrete plants and yoga professionals and this would be a valuable addition to our portfolio. It would go a long way in contributing to the success of govt's flagship Make in India programme," said Mr Adil Zainulbhai, chairman, QCI. According to Dr Dr M K Bhan, ex secretary to the Government of India, Department of Biotechnology, Ministry of Science and Technology,"For a country like India, the twin challenge is to ensure availability of quality healthcare products at reasonable cost so that overall healthcare cost remains reasonable. In this direction, the launch ICMED is a significant collaborative initiative and will go a long way to ensure realization of these objectives."   It may be added that NABCB has already secured international equivalence for most of its accreditation programmes and it would facilitate international acceptance of Indian medical devices. "NABCB is accrediting certification and inspection bodies and its accreditation programmes are internationally equivalent placing it on par with European and American accreditation bodies. This equivalence would help facilitate acceptance of ICMED certification in overseas market," pointed out Mr Anil Jauhri, CEO, NABCB. The manufacturers would need to approach any one of the certification bodies approved by QCI under the Scheme for obtaining certification. The certification bodies shall be under the oversight of NABCB, which as the national accreditation body, would accredit these certifying bodies as per applicable international standards. Among the dignitaries present during the launch function of ICMED included: Mr Amitabh Kant, CEO, NITI Ayog; Mr C Viswanath, secretary, Department of Consumer Affairs; Mr Wajahat Habibullah, chairman, PSAIIF & the Jury; Mr Samir Behl, regional president, Amway, Europe, Africa and India; Mr Bejon Misra, founder, Consumer Online Foundation and Mr G Gurucharan, special secretary, Department of Consumer Affairs. ICMED Backgrounder:   ICMED is the fructification of a MoU was signed between QCI and AIMED on 30 Oct 2014 to fill the regulatory vacuum in quality certification space for medical devices in the country. The scheme has been developed involving various stakeholders with a Steering Committee chaired by Dr MK Bhan, former secretary, Biotechnology, at the helm, supported by a Technical Committee and a Certification Committee constituted for this purpose. More than twenty government and non-government organizations including Department of Commerce, National Health System Resource Centre (NHSRC), Bureau of Indian Standards (BIS), Central Drug Standard Control Organization (CDSCO), Engineering Export Promotion Council (EEPC), prominent industry bodies like AIMED and Confederation of Indian Industry (CII), Center for Biomedical Engineering, IIT Delhi, Indian Medical Association (IMA), etc. participated in various committees.   ]]> https://biospectrumindia.com/features/97/8071/apac-market-to-offer-huge-opportunities-in-cell-analysis.html https://biospectrumindia.com/features/97/8071/apac-market-to-offer-huge-opportunities-in-cell-analysis.html Tue, 15 Mar 2016 14:53:57 +0530 Cell analysis plays a major role in gene identification, protein identification, transcription analysis and epigenomics at cellular level. It proves to be an ultra-sensitive device to elucidate specific molecular processes and pathways and reveal the nature of cell heterogenecity. Hospitals, academic institutions, government bodies, as well as pharmaceutical and biotechnology firms are increasing their focus on application of cell analysis as a modern emerging tool in research, drug discovery and diagnosis. The cell analysis techniques global market is segmented into molecular approaches, image-based approaches and others. The molecular approaches include the PCR, NGS and Microfluidics, cell isolation & separation techniques performed at cells genomic level, where as the image-based approaches include microscopes, FISH, FRAP, tracking, high content screening (HCS), cytometry techniques etc.   The cell analysis products market is mainly segmented into consumables and instruments. The consumables include reagents, assay plates and microplates whereas the instrument segment comprises of microscopes, flow cytometers, spectrophotometer, quantitative polymerase chain reaction (QPCR), microfluidic devices, cell counters, high content screening (HCS) systems and cell microarrays. The APAC regions tend to be an emerging market with an opportunity for growth, and are likely to be a destination of investment for new investors in the cell analysis market. According to a Research and Markets report, the cell analysis market is expected to grow at a rate of 9.6% by 2020. The major factor influencing the growth is enhanced precision of cell imaging and analysis systems which in turn reduce time and cost of drug discovery process.   In addition, the factors like increasing incidence of cancer, increasing government investments, funds and grants, availability of reagents and cell analysis instruments are driving the growth of the market. However, the major market restraints include high capital investments and shortage of skilled labor for high content screening procedure. The biggest opportunities for this market is the emerging APAC market, high content screening services provided by contract research organizations, automation in cancer research for its early diagnosis and reduction of cost in the cancer treatment. The global cell analysis market is a competitive market and all the active players in this market are involved in innovating new and advanced products to maintain their market shares. The key players in the global cell analysis market include Agilent Technologies (US), Becton Dickinson and Company (US), Bio-Rad Laboratories (US), Danaher Corporation (US), GE Healthcare (UK), Merck KGAA (Germany), Olympus Corporation (Japan), PerkinElmer (US), Promega Corporation (US), Qiagen NV (Netherlands), Sigma-Aldrich Corporation (US) and Thermo Fisher Scientific (US). In order to offer the products with better software, most of the players in the cell analysis market are collaborating with companies and educational institutions. ]]> https://biospectrumindia.com/views/97/7721/digitalization-in-service-enables-better-access-to-healthcare.html https://biospectrumindia.com/views/97/7721/digitalization-in-service-enables-better-access-to-healthcare.html Tue, 15 Mar 2016 10:39:04 +0530 In the current healthcare scenario, after-sales service plays a vital role while buying any medical technology equipment. It is the biggest influencer for a clinician today to decide on his investments. For any diagnostic center or healthcare provider, turning away patients is undesirable and one of the causes of this situation is a 'machine breakdown'. This is especially critical in high end equipments such as CT Scanner, MRI Scanner, Cath lab or automated laboratory equipments. How quickly can the machine be up and running was the concern of the past. How well in advance a clinician would know the problem with his system to avoid a major crisis, is the solution of today and tomorrow. The sheer possibility of getting a pre-alert of a fault is a game-changer. This is digitalization in service. Remote accessRemote access of equipments is becoming a part in today's connected world and is used reactively as well as proactively. In the reactive mode it is used to diagnose and fix problems when the customer reports a problem and before an engineer can reach the customer place. In the proactive mode, the equipment keeps informing deviation in performance as and when it occurs while it is in use at the customer site. High end equipments are equipped with this capability to relay critical deviation in performance parameters or errors to a central server of the medical equipment, which is monitored centrally by technical experts of the company. Sitting in Mumbai, these experts can remotely access, for example, an MRI system in Coimbatore, Hubli or anywhere in India and guide the technologist at the customer site what does the alert mean and what needs to be done. So by remote access a possible major crisis can be prevented. The hospital or diagnostic center definitely will not have to cancel any patient appointments. It is also possible to remotely identify spare part failure under certain circumstances and the same can be ordered by the customer care center so that the engineer can actually arrive at the site with the spare part.   There are situations where the problem in the equipment cannot be rectified remotely. A service engineer may have to be assigned to visit the customer place. In a large organization with several engineers, finding who the right engineer is, whether he is free at that point in time, etc., may potentially take time. Here's the digital solution -- the field service engineers posses a smartphone integrated with the call management system, which communicates in real-time to show his/her availability. This enables efficient dispatch of engineers in merely a click of a button from one central place without having to make multiple telephone calls to find out the availability of engineers. This technology has arrived in India as well. What happens on-site?The field service engineer analyses the problems. He either fixes it or confirms replacement of spare part. If spare part replacement is required, he immediately checks the availability of the part in the local warehouse using the smart phone. He orders the part through the app and also announces to the customer how much time it will take for the spare part to arrive and the machine to be up. In this case, the customer may have to shuffle his patient appointments; however, what he is happy about is the transparency. He knows exactly when the machine will be available for scans and accordingly plans his day and appointments. Just couple of years ago, he and his staff might had to continuously turn away patients, as there was no defined clarity on machine being available. This was a big hit on his revenue and also his reputation, especially among his referrals. Benefits of digitalizationIn summary, digitalisation and connectivity has increased efficiency and transparency significantly, to the way a service complaint from a customer is handled and also has enabled proactive service delivery before a breakdown of the equipment occurs. About 35-40 percent of medical equipments require no downtime, if pre-alerts are received and fixed remotely. Digitally ordering the spare parts and maintaining customer transparency works as wonder, as the patient is justified with his requirement of access to healthcare. Globally this is a common scenario, which is now witnessed in India. Organizations like Siemens have been in the forefront to introduce digitalization in service in India for the last 4-5 years.   ]]> https://biospectrumindia.com/news/97/7562/hmd-bagged-make-in-india-initiative-company-of-the-year-award.html https://biospectrumindia.com/news/97/7562/hmd-bagged-make-in-india-initiative-company-of-the-year-award.html Mon, 14 Mar 2016 12:38:57 +0530 Hindustan Medical Devices (HMD), country's leading manufacturer of medical devices and world's largest manufacturer of AD syringes, was conferred the "Make in India Initiative Company of the Year" award at the 6th MT India Healthcare Awards 2016. The verdict was based on the profile, assessment of HMD's achievements and visions, comprehensive online research, customer reviews and patient satisfaction by research conducted by Medgate Today - India's top and world's foremost magazine in medical and healthcare. The recommendation from the eminent panel of jury was the deciding factor for the winning ticket. "We are honoured and we are humbled and we will continue to work towards making 'Make in India' a resounding success," said Mr Rajiv Nath, joint managing director, HMD, on receiving the award. "India can become a global manufacturing hub for medical devices if nurtured with care and supported with proper regulatory support," added Mr Nath. Mr Nath also happens to be the Forum Coordinator and Secretary of Association of Indian Medical Device Industry (AIMED), the national body of domestic medical device manufacturers. Given India's humungous import dependency and loss of quality jobs within country due to this situation, Mr Nath has been engaging with the Government on bringing around policies to create vibrant eco-system for 'Make in India' of medical devices. These include tariff correction, business viability policies, and appropriate regulatory regime to ensure patient safety while also allowing Indian Medical device manufacturers to prove their credibility.   Other important initiatives include advocating - Buy Indian - the preferential market access policy to fight Chinese Govt subsidized competition especially for those devices covered under FTA, creating UdaiMED - a forum for users, developers, academia and industry to interface with the Government. Mr Nath is now actively pushing for a Medical Device Import Substitution Council - the first of its kind under a proposed Ministry of Life Sciences or of Healthcare Products, so that consumers benefit from lower healthcare cost while domestic manufacturing gets a boost. The 6th MT India Healthcare Awards 2016 partnered with Messe Dusseldorf, Germany was held at Goregaon Exhibition and Convention Center, Goregaon , Mumbai. Representatives of 21 countries participated at the award night.   ]]> https://biospectrumindia.com/news/97/8023/essentra-extends-pharma-packaging-footprint-in-india.html https://biospectrumindia.com/news/97/8023/essentra-extends-pharma-packaging-footprint-in-india.html Mon, 14 Mar 2016 12:38:00 +0530 Essentra has a successful joint venture with ITC in Filter Products, which includes a further two manufacturing facilities and 150 employees. It has been present in India for 16 years, and employs 170 people in Bangalore, and through this acquisition will create an additional 120 local jobs. Headquartered in the UK and listed on the FTSE 250, Essentra has c. 9,000 employees across 33 countries. Mr P T Sreekumar, MD - Asia, Essentra, said: "With its highly complementary product range, Kamsri provides us with an entry point into the attractive pharmaceutical and healthcare industries in India, thereby reinforcing our global packaging capabilities and enhancing the opportunities for our customers. Our Health & Personal Care Packaging business now has a manufacturing presence in North America, Europe and India, and ships our extensive range of innovative products to 75 countries worldwide."   The acquired cartons manufacturing assets which will incorporated into Essentra's existing site which opened in late 2013, and accommodates manufacturing, warehousing and commercial infrastructure over 70,000 sq. ft. Essentra India's GM Mr Narayan, said: "Continued growth in the local market, and its increasing status as a high quality, competitive manufacturing base, make India a key opportunity for the Essentra Group. The end-markets for our specialist components, such as healthcare and industrial products, are sizeable and well-established, with annual growth of up to 20%. Following the acquisition of Kamsri, our immediate focus will be adding their cartons capabilities to our existing tear tapes and securing solutions for packaging; however, we plan to further extend our specialist packaging range over the coming year." ]]> https://biospectrumindia.com/news/97/7923/agilent-technologies-launches-new-platform-for-analyzing-cell-free-dna.html https://biospectrumindia.com/news/97/7923/agilent-technologies-launches-new-platform-for-analyzing-cell-free-dna.html Fri, 11 Mar 2016 14:03:09 +0530 Agilent Technologies has introduced OneSight, a new software platform designed to help researchers visualize and analyze chromosomal aneuploidies in cell-free DNA sequencing data. "The study of cell-free DNA is a very active area of research, and we expect growth in applications such as analysis of liquid biopsies and cell-free fetal DNA," said Mr Herman Verrelst, Agilent vice president and general manager of the company's Genomics Solutions Division and Clinical Applications Division. "With OneSight, researchers will be able to gain a deeper understanding of their sequencing data and apply that to a wide range of applications, from the early detection of cancer to screening for fetal abnormalities." Mr Verrelst noted that OneSight offers genetics laboratories a cost-effective way to perform high-quality, cell-free DNA analysis in-house (which used to require an often-prohibitive investment). The software platform is independent of NGS sequencing technology. With an established NGS infrastructure in place, OneSight effectively allows labs to set up an end-to-end cfDNA analysis pipeline. Through the new platform's unique visualization tools and statistical parameters, scientists can now minimize the impact of recurrent technical variations and assess the presence of confounding biological factors such as segmental aberrations and genome-wide chromosomal instability. The new software was developed with expertise from a company Agilent acquired last year, Cartagenia, known for its software solutions for variant assessment and reporting of clinical genomics data.   ]]> https://biospectrumindia.com/news/97/7781/mitigating-disease-outbreaks-with-smart-mapping-technology.html https://biospectrumindia.com/news/97/7781/mitigating-disease-outbreaks-with-smart-mapping-technology.html Wed, 09 Mar 2016 17:21:36 +0530 With Zika virus declared a 'public health emergency' by the World Health Organization (WHO), doctors and scientists world-over are turning to smart mapping technology to learn more about the disease ravaging the Americas and threatening other tropical and sub-tropical regions across the globe. Only invoked in response to the most dangerous threats, the declaration represents the highest level of alert issued by the health authority. To date, WHO has confirmed cases of Zika virus in more than 20 countries and anticipates as many as four million people will become infected by end of the year. "In recent years, the threats from deadly disease outbreaks have increased in both number and complexity," says Esri Singapore's CEO Mr Thomas Pramotedham. "In 2002 to 2003 we saw SARS sweep throughout Asia, then a decade later MERS emerged to affect the Middle East and Korea while at the same time the world was dealing with the largest and longest Ebola outbreak in history.   "In each case, the combination of transient populations and an increase in international trade has provided the perfect conditions for diseases like Zika to spread across borders at an exponential rate," he said. "For cities such as Singapore, the socio-economic implications of a disease outbreak happening within its shores is potentially disastrous."In fact, during the height of the SARS outbreak in early 2003, local studies have shown tourist arrivals and city hotel occupancy rates plunged to an all-time low. Stock prices fell and revenues at retail shops, restaurants, and tour operators registered a fall of up to 80% in sales. "While many lessons have been learnt in combating SARS and other similar cases, those events have also underscored the importance of deploying state-of-the-art mapping technology as an active disease surveillance system," Mr Pramotedham said. The battle against Ebola Smart mapping technology - also known as geographic information system (GIS) technology - integrates data from multiple systems, presenting the findings in the format of a dynamic map. By linking data through their common geography, users are able to analyze, visualize, and detect patterns and trends that might otherwise be missed by other types of analyses. A great example of using smart mapping technology for disease surveillance and control was during the 2014 to 2015 Ebola outbreak in West Africa. When the UN Mission for Ebola Emergency Response was launched, they set a goal to reverse the upward trend of new cases with what WHO called the 70 70 60 plan. That is, 70 percent safe burials - as bodies remain contagious days after death - and 70 percent of the patients isolated within 60 days. At the heart of the UN Mission's operations was smart mapping technology. Both the Centre for Disease Control and Prevention and WHO, leveraged the platform to: evaluate the spread of the disease; map the locations of site treatment units and specialty labs; and, understand cultural practices around burials, languages spoken, transportation routes and more. With such a plethora of information, health authorities were able to effectively allocate resources and facilities for diagnosis, treatment, and care of infected patients. Facilitating community awareness Apart from using smart maps to monitor and control the spread of the disease, other organisations have also used the technology to keep the community informed. "During the SARS crisis in Hong Kong, citizens were anxious and afraid to go outdoors simply for fear of coming into contact with the disease. Since many are aware that the disease spread through proximity, the importance of location suddenly became very real to citizens. They were curious as to where the infected cases were located, and which areas are free of the disease. As result a web-based smart map was launched," Mr Pramotedham said. The smart map, which features data from authoritative sources such as WHO and various government departments, was developed by Esri Hong Kong and was used by residents and visitors to easily check which buildings in their neighbourhoods had, or were suspected as having, cases of SARS. Another example is use of interactive story maps as a way to educate the general public on the Zika virus. By doing so, the public are able to understand more about this threat, and the measures they can take to avoid becoming infected. "Being able to see authoritative information clearly presented on a map helps alleviate fears and concerns in the community. By having access to such information, they are able to make well-informed decisions that can potentially help users protect themselves and their families," he said. Location matters in Health At the end of the day, place matters in health. Socrates, the father of medicine himself, recognised this in his writings. "Whether its figuring out how you can deliver better health outcomes for the community or investigating how you can protect your constituents from a potential disease outbreak, the value of smart maps have brought a powerful advantage that have made healthcare initiatives more effective and impactful," Mr Pramotedham said. "And though we might never know when the next SARS or Zika virus will hit our shores, the community can take comfort in knowing that through the deployment of advanced technologies such as smart mapping - our health authorities and communities will be better prepared and equipped to respond it," he concluded. ]]> https://biospectrumindia.com/news/97/7412/exco-intouch-oracle-health-partner-for-a-new-edc-epro-system-.html https://biospectrumindia.com/news/97/7412/exco-intouch-oracle-health-partner-for-a-new-edc-epro-system-.html Wed, 09 Mar 2016 11:31:05 +0530 Exco InTouch, the leading provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, announces the standardized integration between two "best of breed" solutions to provide a robust, highly integrated electronic data capture (EDC) and electronic patient reported outcomes (ePRO) solution which provides the market with a resource that streamlines workflow processes in clinical research. The integration of Exco InTouch's patient engagement platform with Oracle Health Sciences' market-leading InForm EDC system will deliver enhanced workflow efficiency and improve data quality during clinical trials. Together, through a seamless standards-based service orientated architecture (SOA) integration, this platform provides a complete data capture solution for both clinical and post-marketing studies. For sponsors, CROs and investigator sites, the result is a significant improvement to patient retention, adherence and the overall quality of study data. This highly innovative solution brings multiple benefits to the market. Site and patient captured clinical data, including that taken directly from medical devices, is seamlessly integrated resulting in much more accurate and timely data reporting for clinicians. Furthermore, this approach introduces the opportunity to leverage smartphone technology, removing the need to provide patients with specialized, expensive devices. Underpinned by patented technology, clients can take advantage of a Bring Your Own Device (BYOD) strategy, which enables patients to use their own mobile devices. This is particularly valuable in late phase trials, where the cost of provisioning devices prohibits the use of electronic data capture. This initiative also drives engagement by providing a tailored suite of communication, informational and reporting services throughout the patient journey. The solution created through this joint initiative is set to support sponsors, clinicians and patients through the collection of more accurate and complete study data, significantly reduced logistical complexity and increase patient compliance to trial protocols. Mr Martin Cook, VP of strategic partnerships, Exco InTouch, said, "We are delighted to have formed this strategic partnership with Oracle and, as a consequence of this initiative, to be able to bring highly beneficial innovation to the market with the capability to optimize work flow efficiency and to improve the quality of data captured, both in clinical research and real world health programs." He added, "We are excited by what this partnership has brought to the market. Combining Oracle's Inform system with Exco InTouch's patient engagement technology puts a new solution into the hands of sponsors, clinicians and patients with efficiency benefits that ultimately improve clinical research outcomes. We very much look forward to rolling out our joint solution." ]]> https://biospectrumindia.com/news/97/3415/shimadzu-launches-new-icpms.html https://biospectrumindia.com/news/97/3415/shimadzu-launches-new-icpms.html Wed, 09 Mar 2016 11:30:00 +0530 Shimadzu, one of the world's fastest growing mass spectrometry companies, announced the introduction of the Shimadzu ICPMS-2030 Inductively Coupled Plasma Mass Spectrometer. The new ICPMS-2030 is designed to respond to the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Q3D guidelines for elemental impurities in pharmaceutical products. The ICH Q3D specifies allowable limits of daily intake of 24 elements of toxicological concern, and requires high sensitive and high precision measurement of such elements. The ICPMS-2030 satisfies these requirements with ppt level high sensitivity, which is achieved by newly developed collision cell and optimized internal structure, offering FDA 21 CFR Part 11 compliance, automated analytical method development function, and unique measurement result evaluation function to provide analytical results with exceptionally high reliability. US pharmacopoeia indicates limits of elemental impurities (USP < 232>) and detection technique by ICP-MS (USP < 233>), which will be in effect in January 2018. In USP < 735>, X-ray Fluorescence Spectrometry is adopted as general analytical method. For those demands, Shimadzu offers total solution for elemental impurities analysis from screening without sample preparation by the EDX-7000/8000, FDA 21 CFR Part 11 compliant Energy Dispersive X-ray Fluorescence Spectrometers, to high-sensitive and precision analysis by the ICPMS-2030. The ICPMS-2030 will be exhibited at PITTCON 2016 from March 6th to 10th in Atlanta, GA, USA. Features:Designed for High Sensitivity and Easy MaintenanceThe optimized internal structure including the newly-developed collision cell enables analysis at sub-ppt level sensitivity by minimized spectral interference and improved transmission efficiency of atomic ions, so that precise quantitation results in elemental impurity analysis become more reliable. The sample injection unit and interface unit where ionized atoms go through can be easily removed for maintenance so that stable analysis for longer period can be ensured.   Simplified Analysis and Higher Data Reliability by Assistant Functions and LabSolutions SoftwareIn ICP-MS analysis, conventionally users needed to be skillful and to spend a long time to find the ions that interfere with spectra, select the optimum mass number of the elements to be measured, and determine the calibration curve sample concentration. Using the "Development Assistant" function, users can simply perform qualitative analysis by selecting the elements to be measured. The software then automatically sets the suitable analysis conditions. When performing routine analysis, "Diagnosis Assistant" automatically checks if there is spectral interference and indicates problems if there are any. Shimadzu FDA 21 CFR Part 11 compliant LabSolutions software provides ensured analytical data management. Reduction of Argon Gas Consumption and Lower Running Cost by the Mini-torch and Eco ModeShimadzu unique mini-torch plasma unit significantly reduces the consumption of argon gas. The Eco mode automatically reduces the argon gas flow during standby. In addition, the use with 99.95 percent purity argon gas is guaranteed. Therefore, analysis can be performed using the relatively lower cost argon gas, instead of 99.999 percent or higher purity argon gas generally used. These features greatly reduce costs in laboratory operations.   ]]> https://biospectrumindia.com/news/97/6128/worlds-first-3d-printed-sneezeometer-to-help-asthma-patients.html https://biospectrumindia.com/news/97/6128/worlds-first-3d-printed-sneezeometer-to-help-asthma-patients.html Tue, 08 Mar 2016 16:37:50 +0530 India has an estimated 15-20 million asthmatics with up to 15% of 5-11 year olds suffering the disease Research undertaken at the University of Surrey, UK, has led to the development of the world's first 'sneezeometer', an airflow sensor or 'spirometer' that is sensitive enough to measure the speed of a sneeze. For use in helping to diagnose a variety of respiratory conditions, the sneezeometer is twice as fast, and more sensitive than any other available device. Spirometers measure lung capacity and are used widely to diagnose a variety of chronic and acute respiratory conditions including asthma, Obstructive Sleep Apnoea and Hypopnoea. However, current devices are expensive, cumbersome and lack the sensitivity required in difficult diagnostic situations, such as neonatal care. An ultra-sensitive spirometer, Surrey's sneezeometer measures the flow rate of air through a patient's lungs.   When the patient breathes through the fist-sized instrument, the sneezeometer is fast and sensitive enough to pick up tiny fluctuations in the breath's flow rate, which may be caused by a disease. Because no such instrument has yet been available, researchers are still exploring the diagnostic capabilities. Dr David Birch, of the University of Surrey's Aerodynamics and Environmental Flow research Group explained, "Breathing disorders are highly prevalent in both the developed and developing world. In India, there has been a 30% rise in respiratory disease since 2010[2], with air pollution being a major factor in this massive rise. The diagnosis and monitoring of respiratory diseases is key to proper treatment and we have now developed a simple, low-cost and non-intrusive diagnostic solution that will make doctors' lives easier across the world. Dr Paul Nathan, the sneezometer's co-inventor added, "We have created a portable, highly sensitive and accurate spirometer that can catch the speed of a sneeze. What's almost as impressive is that we created this innovative device using simple 3D printing technology, with all of the prototypes 'printed' around the internal electronics." "Respiratory diseases are especially prevalent in developing cities such as Delhi and Beijing where air quality is a big concern. Air pollution was recently placed in the top ten health risks faced by human beings globally, with the World Health Organization linking air pollution to seven million premature deaths every year," said Dr Prashant Kumar, from the University of Surrey, "The availability of an inexpensive and portable diagnostic device such as this will assist in such diseases being diagnosed, and treated at earlier stages." The Sneezeometer is currently being trialed at King's College Hospital in London where the device may be used to help diagnose a range of conditions from neonatal settings through to animal diseases. Dr Manasi Nandi, Senior Lecturer in Integrative Pharmacology at King's College London commented, "The ability to measure the sensitivity of airflow detection and pull out other information from single breath is very interesting from both a research and clinical perspective. This is currently not picked out with conventional tests, and we have already been using it to mimic testing of asthma." Dr Birch concluded, "From our expertise in wind-tunnel measurement we have translated fundamental research into an incredibly beneficial technology that will have real impact on the lives of patients with chronic illnesses and will make diagnosis faster, cheaper and more accurate." ]]> https://biospectrumindia.com/news/97/7526/cloudnine-hospital-and-practo-collaborate-on-international-womens-day-.html https://biospectrumindia.com/news/97/7526/cloudnine-hospital-and-practo-collaborate-on-international-womens-day-.html Tue, 08 Mar 2016 14:25:49 +0530 To mark the International Women's Day, Cloudnine Hospital, a leading chain of maternity hospital and Practo have entered into a collaboration to create awareness on women's health issues especially amongst working mothers. Leading experts from Cloudnine Hospital will be answering questions on all health issues on Practo Consult - #WhatWomenWant for free. This counselling will start from 12 noon onwards. Counselling experts from Cloudnine Hospital on the panel include Dr Padmanjali K S, senior member of the Indian Pediatric Association, Karnataka Medical Council, Pediatrician at Clodunine Hospital and Dr Shashikala Hande, Gynaecologist and Obestrician at Cloudnine Hospital.  #WhatWomenWant initiative is about spreading awareness about the importance of women's health while providing an easy way for them to get answers to health queries they have about themselves or about their loved ones as well. Practo Consult is a platform made for women who lead increasingly hectic lives and therefore often ignore their health concerns which then often lead to larger more serious issues. Mr Rohit MA, managing director, Cloudnine Hospital said, "Women all around us are playing multiple social roles and are contributing substantially to the needs of the family. This can be stressful at times and health usually takes a back seat. On this International Women's Day, we are collaborating with Practo to create awareness on women's health issues and their management, by encouraging active online interactive sessions with our expert doctors." Mr Shashank ND - founder and CEO - Practo, said, "Practo is on a mission to help mankind live longer healthier lives across the globe. The right to health is a human right and on this day, we want to enable all women to use that right and ask us their health related questions on Practo Consult. The first step to find a solution is to create awareness, and with Practo Consult, we hope that women from all cities across India will be able to get the right answers, for free, from the best doctors. On this Women's Day we continue our march to help women live healthier, longer lives."   Under this initiative, women in tier 2 and tier 3 cities can now get their health queries answered by experts at Cloudnine for free of cost. With Practo's initiative #WhatWomenWant, Practo Consult invites women around the country to seek the right answers to their health queries, so that they can de-stress, care for themselves and their family members in the best way possible and live healthier, longer lives.     ]]> https://biospectrumindia.com/news/97/7431/siemens-to-sell-its-healthcare-business.html https://biospectrumindia.com/news/97/7431/siemens-to-sell-its-healthcare-business.html Mon, 07 Mar 2016 12:28:58 +0530 The Board of Directors of Siemens Limited has approved the sale and transfer of its Healthcare undertaking, as a going concern on a slump sale basis, for a sale consideration of Rs 30,500 million (Indian Rupees Thirty Thousand Five Hundred million), to Siemens Healthcare Private Limited, a subsidiary of Siemens AG. The transaction is subject to requisite regulatory, statutory and shareholder approvals. The consideration for the proposed transaction, recommended by the Audit committee, is based on the valuation undertaken by two independent valuers - Deloitte Touche Tohmatsu India LLP and KPMG India Private Limited. Citigroup Global Markets India Pvt. Ltd. is acting as the transaction advisor to Siemens Limited. Mr Sunil Mathur, managing director and chief executive officer, Siemens Limited, said, "This transaction, follows Siemens AG's global strategy of managing its Healthcare business under a separately-managed company. Over 85 percent of Siemens Ltd Healthcare revenues are currently derived from products imported from Siemens AG. Significant Management focus, including investments will be needed in finding appropriate products and solutions to meet the growing demands of the Indian market. As there are limited synergies between the Healthcare and other businesses of Siemens Ltd, this transaction will enable Siemens Ltd to increase its focus on, and capital allocation to Power Generation, Transmission and Distribution, Mobility, Industrial Automation and Smart Cities segments while enabling Siemens AG to further strengthen its focus on the Healthcare segment in India, by aligning it with its global strategy and management framework." Key Rationale for the Proposed Transaction Healthcare in India: Changing ScenarioIncreasing Government spending, preference for locally manufactured productsGrowth being driven by Tier II / III cities, where preference is for value productsSiemens Ltd.'s Healthcare undertaking is highly dependent on Siemens AG and its subsidiaries for products and technical know-how Significant long-term investments required for localization of products and solutions   Alignment with Global Strategy and Management FrameworkGlobally, Healthcare a separately managed unitAllows increased flexibility, greater entrepreneurial freedom and faster decision making to grow India Healthcare segment independently Benefits for Siemens Ltd. ShareholdersLimited synergies between Healthcare and other segmentsEnhanced focus, capital allocation and resources to further grow in segments of Power Generation, Transmission & Distribution, Mobility, Industrial Automation and Smart CitiesProposed transaction margin accretive for Siemens Ltd. Board of Directors has also decided to consider the distribution of 50% of the sale consideration as reduced by applicable Capital Gains Tax and Dividend Distribution Tax, as a special dividend, at the first Board meeting after the completion of the Proposed Transaction.     ]]> https://biospectrumindia.com/news/97/7837/mr-suresh-vazirani-felicitated-with-the-maker-in-india-award-2015-by-the-lions-club-international-.html https://biospectrumindia.com/news/97/7837/mr-suresh-vazirani-felicitated-with-the-maker-in-india-award-2015-by-the-lions-club-international-.html Fri, 04 Mar 2016 14:31:00 +0530 The award was presented by Mr Raju V Manwani, International Director of Lions Club International (2013-15) and Chief Promoter along with and Mr Ajay Arora, past president, Mumbai SOL. Other prominent people who received this year's awards are Mr. Devendra Fadnavis, Chief Minister of Maharashtra, Commander Mr Rishabh Kapur and television artists, amongst others. The SOL Lions Gold Awards held every year, are a tribute to individuals from different walks of life who have made an outstanding contribution to the society. Mr Vazirani won the 'Maker in India' Award for his outstanding efforts in design, innovation and sustainability over last 36 years that has helped place India on the global diagnostic industry map. He was awarded in the Special Category encompassing pioneers from fields as diverse as Sports, Bravery, Business, and Medicine among others. As the 'Make in India' wave sweeps the nation, this recognition has come at an apt time and close on the heels of yet another award! Recently Mr Vazirani was also bestowed with the 'Pioneer for the Make in India Concept' Award, 2015 by Dr Harsh Vardhan - Hon'ble Minister of Science and Technology and Earth Sciences, Govt. of India. On receiving the award, Mr Vazirani remarked, "I feel a sense of joy and pride, as Transasia succeeds in catering to the global diagnostic needs in over 100 countries through its high quality and affordable products. I am a proud Indian today and grateful to Lions International for this honor." The Lions Club International is the world's largest service club organization started in 1917 and has 1.37 million members, working globally towards a common goal of 'improving our communities'. From providing instant assistance during sudden disasters to, helping visually challenged people see again or taking over the education of abandoned families, the Lions Club has created a huge impact on society by and large.   ]]> https://biospectrumindia.com/news/97/3667/cognizant-develops-new-digital-healthcare-platform.html https://biospectrumindia.com/news/97/3667/cognizant-develops-new-digital-healthcare-platform.html Thu, 03 Mar 2016 13:00:50 +0530 Cognizant announced the development of a new digital healthcare platform, Cognizant Health TranZform. Developed with technology from Orion Health, this new digital platform will help consumers make more informed decisions about the cost and quality of their care, while simultaneously enabling healthcare providers and payers to drive greater levels of consumer engagement and operational efficiency.  With the healthcare industry shifting from fee-for-service to value-based care, traditional healthcare organizations are increasingly transforming their business models to deliver consumer-centric care. The Health TranZform platform will serve as a cloud-based industry utility, enabling different healthcare stakeholders to easily interact with each other and consumers across the care continuum. By creating a secure platform, data from multiple systems, including payer data from Cognizant's TriZetto payer core administration platforms, data from physician practice management systems and other healthcare ecosystem platforms can be integrated with electronic health records (EHR), to provide an improved customer experience and drive new solutions. "Successfully engaging and empowering the healthcare consumer and delivering value-based care will require broad new digital and business process capabilities that allow for more personalization, self-service and more control over care decisions," said Mr Krish Venkat, president, Healthcare and Life Sciences at Cognizant. "We are working with leading global partners like Orion Health to integrate capabilities into the Cognizant Health TranZform platform that will give health care organizations a cost-effective, seamless way to provide a differentiated, high-value, customer-centric experience." "We are excited to bring the strengths of our technologies together to enable Cognizant Health TranZform to integrate and orchestrate clinical, social, consumer-generated, and financial data across multiple sources and vendors," said Mr Ian McCrae, CEO for Orion Health. "Orion has been working to create a new model for collaboration across healthcare stakeholders and our relationship with Cognizant will create a significant opportunity to expand the breadth of data we derive insights from." "We already use Orion Health as a core part of our integration strategy," said Mr Dave Watson, CEO for Cal Index which is leading one of the largest payer sponsored healthcare integration projects in the US. "We are even more excited now that this new partnership brings Cognizant's products, services, scale, digital expertise and payer heritage to align to our strategy for growth and development." Cognizant is showcasing its Health TranZform platform and other innovative healthcare solutions at the 2016 Healthcare Information and Management Systems Society (HIMSS) Conference and Exhibition at booth number #1416. During HIMSS16, Cognizant and Orion will showcase how Cognizant Health TranZform will leverage Orion's deep clinical heritage and Cognizant's payer heritage and scale, to focus on building solutions that address complex business challenges while enabling a level of cross-ecosystem collaboration that has not previously been possible in healthcare. ]]> https://biospectrumindia.com/news/97/4365/medtech-industry-seeks-immediate-and-complete-roll-back-of-import-duty-increase-.html https://biospectrumindia.com/news/97/4365/medtech-industry-seeks-immediate-and-complete-roll-back-of-import-duty-increase-.html Thu, 03 Mar 2016 13:00:38 +0530 Indian Medical Device and Equipment sector is largely supported by Imports for meeting the healthcare needs of the country. FICCI welcomes Government's recent move to relax import duty on spare and parts used to manufacture and maintain medical devices in India. This was long awaited to give necessary impetus to Indigenous Industry. However, a simultaneous hike in import duty of medical equipment and devices and the resultant cost implications on care provision are likely to affect affordability of medical care in the country. This sector being highly technology - intensive, thrives on innovations which require an ecosystem for development and manufacturing complex medical devices and equipment. The 7 percent increase in duty hike coupled by high foreign exchange related pricing pressures puts med tech industry under stress as it endeavours to deliver affordable, quality medical access to all sections of population. Mr Milan Rao, chairman-FICCI Medical Electronics Forum (MEF) suggests that, "High end and complex equipment and devices such as MRIs, CTs, Cyclotrons, new generation heart valves, grafts, oxygenators, etc. require technology transfer, ecosystem for manufacturing , manpower skills and robust supply chain, all of which are time consuming. Hence, any such duty increases for technologically advanced equipment and devices must be introduced in a phased manner over 3-5 years." India is facing a tremendous opportunity in scaling up Med-Tech sector from US$ 5Bn to $10 billion by 2020. "In order to maintain this growth trajectory and encourage investments in indigenous manufacturing the sector should be incentivized. In light of Make in India's realization and continued affordable healthcare access in country the increase in Customs duties should be reviewed," said Mr Probir Das, chairman FICCI Medical Devices Forum (MDF).     ]]> https://biospectrumindia.com/news/97/8277/how-the-industry-sees-the-union-budget-2016.html https://biospectrumindia.com/news/97/8277/how-the-industry-sees-the-union-budget-2016.html Tue, 01 Mar 2016 11:16:10 +0530 Mr Satish Reddy, chairman, Dr Reddy's Laboratories on Union Budget 2016: "Budget 2016 has been a mixed bag overall. The focus on infrastructure, rural development and social sector spending are important catalysts for boosting the economy's growth rate. On the healthcare front, the budgetary emphasis on the sector was fairly muted. While certain initiatives such as the new health insurance scheme or the National Dialysis Services program are good, perhaps a more holistic, well rounded thrust would have served the sector better in delivering good health to those in need of it. The initial outlay of 1,000 crores to fund higher education is simply not enough, given the huge gap and growing need for students to have access to high quality education. One hopes that the government will build upon this and expand access to higher education to a much larger section of society. The plan to set up the National Board of Skill Development in partnership with industry and academia is definitely a step in the right direction. This move will foster an environment of understanding and collaboration that will ensure skill development is mapped to industry needs, thereby creating more job opportunities in the long run.   The finance minister began his speech by articulating the 9 pillars on which his budget proposals were built, that would have a transformative impact on the economy and people. The social sector, including healthcare was in the top 5. We now look forward to a positive impact on this important aspect of India's growth story." Mr Gautam Khanna, CEO - P. D. Hinduja Hospital and Medical Research Centre Union Budget 2016: "Social sector with healthcare" is one of the 9 pillars of the Union Budget 2016-17. This year's budget has focused at few specific schemes like the National Dialysis Program and the Pradhan Mantri Jan Aushadhi Yojana. 2.2 lakh renal patients are added every year in India and the distribution of health facilities in the country is skewed. The proposed National Dialysis Program would make treatment more accessible. Likewise, 3,000 medical stores will be opened under Pradhan Mantri Jan Aushadhi Yojana to make quality medicine available.But it is important that these schemes are executed and monitored such that the maximum benefit reaches to the patients who need them the most. This year's budget once again left out key areas like overall healthcare spending, National Health Mission, Universal Health Coverage, health infrastructure and primary and secondary healthcare. The new health insurance schemes are a step to make healthcare affordable to the vulnerable sections. Rs. 1804 cr. have been allocated for skill development. We await the details if there are plans to boost skill development in the healthcare sector (trained medical technicians etc.). Another area of concern is the reduction of benefits of deductions for research from 150 to 100 percent from 1st April 2020. This may impact the funding for medical research. Overall, the Union Budget 2016-17 could have done more in terms of greater public spending in healthcare to strengthen public healthcare and build infrastructure and manpower capacity to bridge the current gaps in the sector." Mr Rajiv Nath, forum coordinator AIMED and joint managing director, Hindustan Syringes and Medical Devices(HMD)on Budget 2016: "Finance Minister Shri Arun Jaitley must be applauded for bringing budget's focus on rural community as well as senior citizens. Budget's proposal to set up 3,000 medicine shops in rural areas and announcement of insurance scheme for senior citizens is noteworthy. But then, given India's humungous population with majority of people having very modest income, the biggest challenge that our country faces is to ensure low cost quality healthcare access for majority of citizens.Government needs to realize that medicines are just one component of healthcare cost and very often not its major component! Medical devices can be equally if not more as critical a part of overall healthcare cost as medicines and diagnostics. If the government had focused on giving a major boost to medical device manufacturing in the country and also ensured a robust MRP regime, then it would have served many purpose with one shot - i.e. (a) Lower the overall healthcare cost and (b) lead to sharp reduction on import dependency and growth in exports. The additional critical benefit would have been quality job creation within the country. Anyway, we are still awaiting the fine print and we are just hoping that some of our pre-budget recommendations have been incorporated. These include: (a) Withdrawal of Concessional Duty Notification of Basic Duty and Special Additional Duty of Medical Devices and for reverting of Duty on the items covered under HS 90.27, 30.06 and 38.22 ( mainly diagnostics - equipments & reagents) (b) Imposition of 10 percent Basic Duty on HS 90.27 & HS 30.06 (C) reduction in duty of raw materials to 2.5 percent to produce above devices and diagnostics .In addition, we also need to think of consumers and dept should consider to introduce an Tax Innovation Structure of stalling Artificial Inflation of MRP by imposing a 2 percent CVD on MRP based criteria with Abatement of at least 50 percent (in case 1 percent Excise Duty on MRP is not possible) to have a disincentive to importers from passing on above increase to the Consumers. This will make Indian Medical Devices including Diagnostics competitive and safeguard consumers from exploitation."       ]]> https://biospectrumindia.com/news/97/5038/ibmnew-york-genome-center-to-create-cancer-data-repository-.html https://biospectrumindia.com/news/97/5038/ibmnew-york-genome-center-to-create-cancer-data-repository-.html Mon, 29 Feb 2016 12:48:56 +0530 At White House Precision Medicine Initiative Summit, the New York Genome Center and IBM announced that they are collaborating to create a comprehensive and open repository of genetic data to accelerate cancer research and scale access to precision medicine using cognitive insights from IBM Watson. Analyzing this data alongside the medical community's growing knowledge about cancer could help accelerate the ability of doctors to deliver personalized treatment to individual patients. IBM and New York Genome Center are working together to build the capacity to house the contributed data, train Watson's cognitive computing capabilities for genomic analysis and enable the Center's member institutions and other research collaborators to sequence and analyze DNA and RNA from patients' tumors. In the first phase of the project, the two organizations will examine genetic information from 200 cancer patients to compare how different types of sequencing might impact possible treatment options - examining whole genome and whole exome sequencing as well as clinical panels currently in wide use. Sequencing and clinical data will be fed into Watson to accelerate and focus reviews of massive amounts of medical evidence to help identify existing drugs that may be candidates to target patients' cancer-causing mutations. Clinically relevant insights will be returned to each individual patient's physician to potentially support the physician's treatment decisions. The organizations seek to expand this collaboration with funding from additional partners to further the data repository's growth and adoption. Dr Robert B. Darnell, New York Genome Center's founding director and CEO, said, "Our vision is to create a comprehensive cancer data repository that combines whole genome, exome, targeted panel and phenotypic data in an open platform that will empower researchers and clinicians. We believe that iterative analysis of the data and integration with our growing knowledge of cancer will allow doctors to provide better, personalized treatment."   Whole genome sequencing can play an important role in informing cancer research and treatment. Access to and interpretation of this type of genomic data, however, is currently limited. By combining genetic and clinical information from patients, IBM and New York Genome Center plan to pool resources and talent while also collaborating with a variety of IBM partners and New York Genome Center members, philanthropic partners, and New York State supporters. "Data is quickly becoming one of the most valuable resources in the fight against cancer," said Dr John Kelly III, senior vice president, Cognitive Solutions and IBM Research. "By amassing this contributed data and applying cognitive insights to the challenge of analyzing cancer data, we believe we can soon scale access to precision medicine worldwide." All contributed data will be maintained in a HIPAA enabled repository, in de-identified form. The effort was announced as part of President Obama's Precision Medicine Initiative on 25 Feb 2016 at a White House Summit.     ]]> https://biospectrumindia.com/news/97/8450/eppendorf-india-opens-new-facility-in-chennai.html https://biospectrumindia.com/news/97/8450/eppendorf-india-opens-new-facility-in-chennai.html Fri, 26 Feb 2016 12:17:00 +0530 Manned by a compact, elite team of scientists and engineers, this new facility will work on the skill development of Indian scientific fraternity by conducting world class training programs. The customer experience centre will showcase innovative technologies to new and existing customers. Highlights of the new 46,000 square feet facility include:a. Pipette calibration facility accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL)b. NABL certified workshop for calibration services for temperature, speed and time c. State-of-the-art laboratory and training facility d. 10,000 square feet of warehouse and a private bond store to deliver products even quicker to our customers Mr Thomas Bachmann, chairman and CEO of the Eppendorf Group said, "One of the cornerstones of our business strategy is to strengthen our global market position through targeted investments in both our sales structure and expansion of our training and service portfolio. Entering new product categories such as the Eppendorf Cell Culture Consumables are opening up new application areas and access to new customer groups. The new facility in India will be an important factor in these new product initiatives." Mr Vancheeswaran Sankaranarayanan, managing director and CEO, Eppendorf India said, "During the decade-long presence of Eppendorf in India, we have extended significant support to the life sciences and biotechnology industry in India. Our dominant market position in India demonstrates the superiority of our products and underscores the importance of our training and service workshops extended to the clients' R&D scientists continuously. With continually increasing demand for our premium products and services in India, Eppendorf India will work to increase considerably our customer-focused initiatives with our new Customer Experience & Training Centre."     ]]> https://biospectrumindia.com/news/97/6437/strands-ngs-lab-to-receive-cap-nabl-accreditations.html https://biospectrumindia.com/news/97/6437/strands-ngs-lab-to-receive-cap-nabl-accreditations.html Fri, 26 Feb 2016 12:16:51 +0530 Strand Life Sciences, a global genomic profiling company aimed at empowering personalized cancer care and genetic testing for inherited diseases, announced that its Next-Generation Sequencing (NGS) laboratory, the Strand Center for Genomics & Personalized Medicine, located at Bangalore, has recently received certificates of accreditation from the College of American Pathologists (CAP), and the National Accreditation Board for Testing & Calibration Laboratories (NABL), respectively. The CAP laboratory accreditation program is recognized by the U.S. federal government as equal-to or more-stringent-than the government's own laboratory inspection programs. Similarly, the accreditation by NABL, the sole government-authorized laboratory accreditation body in India, is in accordance with ISO 15189:2012 standards. The accrediting processes by both organizations are designed to ensure that laboratories comply with the highest standards, and adhere to rigorous criteria for quality assurance. During the CAP accreditation process, inspectors examine the laboratory's quality system, quality control protocols and records for the preceding two years.   Both programs pay very close attention to staff qualification, equipment, safety programs, and overall management of clinical laboratories. This recognition by CAP and NABL accredits three of the most popular tests offered by the Strand Center laboratory. First, the StrandAdvantage 48-gene Test, used by medical oncologists to profile cancer patients for somatic mutations and personalize treatment by selecting targeted therapies. Second, the Strand Germline Cancer Test, an 86-gene hereditary cancer test to estimate inherited cancer risk, enabling early detection & prevention. Third, the Strand Rare Diseases Test, covering more than 500 genes and 400 rare inherited diseases, used for confirmation of diagnosis and carrier testing in couples. Dr Vijay Chandru, Executive Chairman, Strand Life Sciences, stated, "We are extremely proud to receive CAP and NABL accreditations. Receiving these accreditations is a major accomplishment, because it reaffirms our commitment to providing the highest quality of diagnostic testing and services to hospitals, physicians, and most importantly patients across the country. It is Strand's goal to bring genomics-based precision medicine to routine clinical practice; hence the accreditations serve as an important milestone in that direction". Dr Chandru added, "We believe Strand's NGS laboratory is the first and only CAP and NABL accredited laboratory in India. As the regional leader in this advanced field of multi-gene testing in genomic medicine, it is important for us to set the highest laboratory standards." "It is imperative that physicians feel confident while sending patient samples for specialized and esoteric testing, such as NGS for cancer and rare inherited disorders. These diagnostic tests require advanced laboratories and expert personnel to analyze and interpret complex genetic information. Laboratories whose quality systems have been accredited by organizations such as CAP and NABL will give physicians much needed confidence to refer precious patient samples" said Dr Nanda Rajaneesh, Consultant Surgical Oncologist, Apollo Spectra Hospitals, Bangalore. Dr Preveen Ramamoorthy, Global Head of Diagnostics, Strand Life Sciences, said, "Our NGS facility in Aurora, Colorado, is a Clinical Laboratory Improvement Amendments (CLIA) accredited laboratory. Now, the accreditation of our India facility by CAP and NABL (ISO 15189) validates our ability to perform high quality clinical NGS testing and perform bioinformatics and clinical interpretation to international quality standards in every facility that we operate. ]]> https://biospectrumindia.com/news/97/8213/philips-to-introduce-cloud-based-data-recovery-service-for-healthcare-.html https://biospectrumindia.com/news/97/8213/philips-to-introduce-cloud-based-data-recovery-service-for-healthcare-.html Fri, 26 Feb 2016 12:16:05 +0530 Royal Philips has announced the introduction of a secure data recovery service, built in collaboration with Amazon Web Services (AWS), that rapidly captures and backs up an entire healthcare organization's data repository in the cloud. Specifically tailored to meet the needs of medical data backup, Philips' new storage service helps healthcare enterprises to further secure patient-critical information against local data loss events, ranging from equipment failure to catastrophic events such as earthquake, fire and flood. With this new storage solution, Philips and AWS continue to strengthen their collaboration to deliver innovative solutions that accelerate the industry's transformation toward a more connected, value-based, patient-centered care model. Philips' new hybrid storage solution combines the company's expertise in medical data management with AWS' petabyte-scale data transport service, AWS Import/Export Snowball, to integrate, manage, encrypt and transfer a hospital's entire data repository to the cloud within days, rather than the weeks or months it would take via a wired network. Using the Philips data recovery service, a hospital organization's IT department simply plugs an AWS Import/Export Snowball device into its network, invokes the appropriate security features, and transfers the required data to the unit. The device is then physically shipped back and the data transferred to Philips' HealthSuite digital platform, an open cloud-based platform that allows the creation of the next generation of connected health and clinical IT innovations. Vendor neutral in terms of the type, format and source of the data, the Philips solution manages security, identity and access, auditing, logging and traceability associated with medical data backup. The goal is to deliver a service that would meet the requirements of the US Health Insurance Portability and Accountability Act (HIPAA) by the second half of 2016. In addition to meeting one-time backup requirements, Philips' HealthSuite data recovery storage service is designed to assist in meeting the ongoing backup needs of healthcare IT departments. One or more of AWS' 50 terabyte data transport devices will remain on-site to provide a local backup, from which all or parts of the data can be quickly recovered. Philips HealthSuite digital platform will provide users with the option of adding powerful data analytics, such as population studies, and sophisticated reporting features. It will also offer them the ability to transfer files to or from the cloud via a secure Philips network connection. "Due to the nature of their data, many healthcare organizations have understandably in the past adopted in-house solutions, but the explosion in the amount of data they now need to secure, together with new regulatory requirements, mean that they need to adopt a different approach," said Mr Dale Wiggins, general manager HealthSuite digital platform, Philips. "By working together with AWS we can offer our customers a next-generation solution enabled by our HealthSuite platform that removes the time and cost barriers of cloud-based healthcare data backup and management." "We're excited to bring the value of the cloud to even more healthcare organizations in collaboration with Philips," said Mr Bill Vass, vice president, AWS Storage Solutions. "By combining the expertise of Philips' HealthSuite with the power of our AWS Import/Export Snowball service, which transfers petabyte-scale data with secure appliances into and out of AWS, healthcare customers will be able to securely and reliably back up their important patient data to the cloud." An early adopter of AWS technologies, Philips previously announced a collaboration with AWS focused on the AWS IoT service to enable an ecosystem for new types of connected and personalized eHealth solutions. Philips will showcase its new HealthSuite recovery data management solution at booth #3416 at the Healthcare Information and Management Systems Society (HIMSS) 2016 Annual Meeting and Exhibition, taking place Feb. 29 - March 4, at the Sands Expo in Las Vegas, NV. ]]> https://biospectrumindia.com/news/97/7021/ika-launches-new-batch-mill.html https://biospectrumindia.com/news/97/7021/ika-launches-new-batch-mill.html Wed, 24 Feb 2016 15:11:10 +0530 IKA Group launches the TUBE MILL control and the TUBE MILL 100 control that represents a unique product innovation - the world's first batch mill with single-use milling vessels. For the first time, this unit will enable serial testing to be carried out under reproducible, contamination-free conditions. The single-use milling vessels reduce the cleaning, time and energy that is devoted to the application process. These vessels also prevent cross contamination of the sample material - a major advantage for quality assurance. The 40 ml and 100 ml capacity milling vessels and hood are made from transparent material, allowing sample milling to be observed during the process itself. With the Tube Mill 100 control larger grinding chambers with a maximum volume of 100 ml (MT 100) can now be used. For sterile applications you can use the sterile disposable grinding chamber MT 40-10 sterile with a stainless steel beater. It reduces soft, medium, hard and brittle materials with a Mohs hardness of up to 5 (manganese or apatite: 5 Mohs). The unit is easy to operate thanks to the user-friendly, multilingual OLED display and timer function. The Tube Mill's versatility is particularly noteworthy. The IKA Tube Mill control can be used to process hard and soft, brittle and dry material. In combination with dry ice, it also allows damp, fatty, elastic and fibrous materials to be milled thoroughly.   The wide speed range of this unit equates to processing times that are less than one minute for most samples. Particular attention was paid to safety in the development of this mill, which only operates if the hood is closed and the milling vessel is connected to the motor and properly secured. If any of these safety features are omitted, an error message is displayed. The milling vessel cannot be opened during the milling process. A labyrinth seal on the motor prevents dust escaping from the milling vessel and getting into the motor. In case of pollution the coupling of the motor can be removed and cleaned very easily. The speed is infinitely adjustable from 5,000 to 25,000 l/min. Again, safety is ensured by a combination of an adjustable safety speed and adjustable safety time function. For instance, these features will prevent samples from overheating. Tests can also be controlled and documented via a USB interface. The latest firmware can be downloaded via the associated interface. In developing the Tube Mill, IKA was able to draw on 105 years of laboratory technology experience, in addition to the more recent experiences involving the award winning UTTD single-use dispersing system.   ]]> https://biospectrumindia.com/news/97/3471/smart-financing-key-to-sustainable-growth-of-the-healthcare-sector-sfs-study.html https://biospectrumindia.com/news/97/3471/smart-financing-key-to-sustainable-growth-of-the-healthcare-sector-sfs-study.html Wed, 24 Feb 2016 11:31:13 +0530 Siemens Financial Services (SFS) commissioned and released a new research report on 'Smart Financing in the Healthcare sector' and reveals how it is set to be a game-changer for Healthcare and related industries. The qualitative research was conducted with healthcare providers across 13 countries which revealed that organizations are facing four common pressures: demographic change; shifting patient expectations; requirement to reform and the rising tide of healthcare technology trends. Digitalization and Smart Financing have been recognised as the ultimate remedy for the increasing pressures in healthcare. Over half of healthcare CFOs surveyed are already using a range of financing techniques, among which asset finance is the most popular. The study highlights that healthcare professionals regard new-generation technology as critical in enabling their organizations to transform. Moreover, more than half of the CFOs interviewed said investment in new-generation technology is 'an urgent priority'. Digitalization and automation are seen as vital cogs to enable the transition, particularly with the move to early detection, value-based reimbursement models and population health management. In this respect, respondents cited three new-generation technology investment priorities: imaging and diagnostics; IT and electronic patient records management; surgery and surgical automation.   The research reveals that smart finance - such as leasing and renting-based packages - is seen as critical to healthcare organizations' ability to manage the changing demands in workflow and also to avert crisis. Flexible financing techniques are becoming an increasingly important part of the healthcare CFO's financial toolkit, as healthcare organizations face global pressure to change despite the constraint of financial resources. "With the healthcare industry facing pressures due to demographic change; shifting patient expectations; requirement to reform and the rising tide of healthcare technology trends and digitalization CFOs of healthcare organizations are prioritizing where valuable funds are directed. Smart financing techniques are increasingly critical in enabling organizations to acquire the new-generation, digitalized technology that is so fundamental in managing pressures to change" said Mr Sunil Kapoor, CEO, Siemens Financial Services (India). Chief Financial Officers in healthcare organizations were interviewed by telephone in a qualitative research study between August and October 2015. The interviewees came from public and private healthcare institutions in the following countries: India, China, Finland, France, Germany, Norway, Poland, Russia, Spain, Sweden, Turkey, UK and USA. Respondents were asked to give their views on the pressures to change faced by their institutions (their nature and severity), the role played by new-generation technology (particularly, but not exclusively, digitalized technology) in enabling effective change, and the use of a range of financing techniques to enable that technology acquisition.     ]]> https://biospectrumindia.com/news/97/8105/indias-medical-devices-market-will-hit-17-6-bn-by-2020-globaldata.html https://biospectrumindia.com/news/97/8105/indias-medical-devices-market-will-hit-17-6-bn-by-2020-globaldata.html Tue, 23 Feb 2016 11:07:50 +0530 The medical devices space in India will see impressive expansion, rising from $10.4 billion in 2014 to reach $17.6 billion by 2020, representing a robust Compound Annual Growth Rate (CAGR) of 9.4 percent, according to research and consulting firm GlobalData. The company's report states that although this market will not see the same level of growth as the pharmaceutical sector, it will still undergo significant changes, driven by mounting patient awareness of advancements in medical technology, and an aging population. Mr Adam Dion, GlobalData's senior industry analyst, says that India's medical device market is one of the fastest-growing, thanks to the country's strong economic growth, improving living standards and large population. Mr Dion comments, "Purchasing power within the country has been rising gradually over the last two decades due to high and consistent economic growth and increasing job opportunities. The influx of people has resulted in more densely-populated cities and, by extension, an increased demand for medical facilities and devices." "In addition to benefiting from increased purchasing power within the region itself, the Indian medical devices arena is also profiting from a booming medical tourism market, which is driven by the comparatively low cost of treatments," he added.   In terms of current opportunities within the medical devices arena, ophthalmic devices take up the largest proportion of market share. In 2014, sales for these devices were valued at approximately $3 billion, having grown at a CAGR of 7.3 percent from $1.98 billion in 2008. Mr Dion further notes that, "Johnson & Johnson Vision Care and Essilor International are the current market leaders in India's ophthalmology devices space, but they face competition from several major players, such as Carl Zeiss, Bausch & Lomb (i.e. Valeant), and Novartis' Alcon subsidiary."   ]]> https://biospectrumindia.com/news/97/8285/focus-on-disruptive-technologies-to-boost-make-in-india.html https://biospectrumindia.com/news/97/8285/focus-on-disruptive-technologies-to-boost-make-in-india.html Fri, 19 Feb 2016 11:30:31 +0530 A new study, 'Make in India: How could we be strategic?' has identified five key technologies as having the maximum potential to stimulate growth in Indian manufacturing: biotechnology, nanotechnology, micro and nanoelectronics, photonics, and advanced materials. These five knowledge intensive technology areas have wide-ranging applications across various industrial sectors with the potential to meet national security priorities, stimulate economic growth as well as meet social development imperatives. The study by the Council on Energy, Environment and Water (CEEW) was released days after the introduction of the National Capital Goods Policy during the Make in India Week programme in Mumbai. The National Capital Goods Policy includes a provision for a Technology Development Fund and other commitments such as increasing skill availability, ensuring mandatory standards and promoting growth and capacity building of Micro, Small and Medium Enterprises (MSMEs). The study identifies how to deploy the fund most effectively. Mr Vaibhav Gupta, junior research associate, CEEW, said, "Our analysis finds that a large share of the total manufacturing output (calculated in terms of gross value addition) can be impacted by the identified technologies: Biotechnology (15 percent), nanotechnology (86 percent), micro and nanoelectronics (100 percent), photonics (19 percent), and advanced materials (40 percent)." However, the existing innovation support system to help translate research efforts across these identified technologies and other areas into commercial products is nascent in India. One key hurdle preventing India from becoming an innovation hub is the abysmal participation of the private sector in R&D, by way of financing. The private sector contributes to less than one-third of the overall R&D spending in the country due to the associated risks in investment and technology failure. Importing components and licensing of intellectual property (from overseas) is the current approach across the strategic sectors. In the long run, this presents the biggest threat to innovation in India. The study recommends that the public sector must don the role of 'risk capital' provider and move away from granting soft-loans for research to a royalty based system that allows for revenues to flow back to the public corpus, should the idea become a commercial success.   As a solution the study also showcases the design of a centralised one-stop technology information portal that provides a range of information - open funding opportunities, status of existing grants, outcomes, partner opportunities, etc. Such an extensive database could help identify emerging areas of research, reduce doubling of effort, target limited resources more strategically, and assess the impact of R&D investments especially in facilitating more links between technology developers and industry. Another key challenge is the inefficient and understaffed Indian Patents Office (IPO). The IPO has an ever increasing backlog of unexamined patents and trademark applications. In 2012 there were 123,255 pending patent applications, which have further increased to 246,495 pending patent applications (in addition to the 532,682 pending trademark applications) in 2015. IPO staff in India experience the highest per capita workload (20 applications a month, as compared with seven in Europe and China, eight in the United States) at the lowest pay. However, 490 patent personnel have been recently recruited to improve the efficiency of the Indian Patent Office. The study suggests that capacity expansion of the IPO (both funding and manpower) and outsourcing 'prior-art' searches to third party service providers will significantly improve the efficiency of the patent filing and approval process. In addition, fast-track IP courts for patent infringements and a patent prosecution highway would accelerate patent prosecution procedures. A fee based revenue model is necessary to enable the IPO to sustain its operations in the long run and operate in autonomy. The third significant factor hampering the pursuit of strategic technologies is the quality and standards associated with domestically manufactured finished-goods and intermediates. Indian industry, to remain competitive and keep costs lower, must have significant backward integration with domestic suppliers of components and raw materials. However, in many cases the physical and chemical properties of intermediates and raw materials do not meet international (or even) national standards. This in turn, adversely impacts the quality of final products. The study finds a pivotal role for an accreditation entity such as (NABL) to certify the bulk of testing laboratories across the country. Currently, only one percent of the laboratories are accredited by NABL. To promote the development of quality products in the five identified areas, mandatory certification of products enabled by these technologies must be enforced. This will set the bar for new entrants and create a larger market for domestically manufactured goods. Dr Arunabha Ghosh, CEO, CEEW, said, "For a competitive manufacturing driven economy, we have to focus on three transitions: from resource vulnerability to securing resources, from acquiring technology from overseas (for domestic use) to developing high technology domestically, and from education and skills to R&D and innovation. A slew of reforms identified in the study are necessary to set the innovation ecosystem in India right. Creating this sustaining eco-system must be made an important objective of the Make in India campaign." .   ]]> https://biospectrumindia.com/news/97/1759/fda-approves-medtronics-deep-brain-stimulation-.html https://biospectrumindia.com/news/97/1759/fda-approves-medtronics-deep-brain-stimulation-.html Fri, 19 Feb 2016 11:29:36 +0530 Medtronic announced the US Food and Drug Administration (US FDA) approval of Medtronic Deep Brain Stimulation (DBS) Therapy for use in people with Parkinson's disease of at least four years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication. In 2002, the FDA initially approved Medtronic DBS Therapy for use in patients with advanced Parkinson's disease. Medtronic DBS has demonstrated improvement in motor complications, quality of life, activities of daily living and reduction in medication usage in individuals with Parkinson's disease. Motor complications caused by the disease and/or as a side effect of levodopa result in great social and psychological disability. Interference with activities of daily living is often severe and the cost of treatment and care increases along with deterioration of quality of life for patients and their caregivers. Thirty-seven percent of people with Parkinson's retire earlier than those without the disease, retiring an average of six years earlier because of the disease. The economic impact of Parkinson's disease is at least $14.4 billion a year in the United States and it is estimated that the prevalence of the disease will more than double in the United States by the year 2040. This recent approval by the FDA was based on data from the EARLYSTIM clinical study, published in the New England Journal of Medicine in 2013, which found that patients treated with Medtronic DBS Therapy and best medical therapy (BMT) reported a mean improvement of 26 percent in their disease-related quality of life at two years, compared to a one percent decline in patients treated with BMT alone. In a study of patients with longer-standing motor complications, DBS patients' quality of life improved 20 percent from baseline to six months compared to no improvement in the patients treated with BMT alone. "Parkinson's disease is progressive, and as a result a patient's quality of life will deteriorate over time. This approval is important because it expands the therapeutic window when patients can benefit from DBS," said Dr Lothar Krinke,vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. "Medtronic's goal is to advance medical care and deliver the best possible patient outcomes. DBS is proven to provide long-term benefits and it can now be used sooner in the care continuum, giving patients with recent onset motor complications another option to maintain or restore quality of life." Impaired motor complications are associated with decreased quality of life, and the impact is similar for patients with recent onset or longer-standing motor complications. In the EARLYSTIM study, 85 percent of patients who received DBS along with BMT had a clinically meaningful improvement compared to only 36 percent in the BMT alone group over 24 months. Thirty percent of patients that remained on BMT alone got worse over 24 months compared to only two percent in the DBS group. The study also found a 61 percent improvement in levodopa-induced complications, including dyskinesias and motor fluctuations, in participants receiving Medtronic DBS therapy at two years, compared to a 13 percent worsening in those only receiving BMT. Additionally, a long-term study of people with advanced Parkinson's disease who received DBS therapy show benefits at 10 years, despite potential surgical and device-related complications.   ]]> https://biospectrumindia.com/news/97/8448/bausch-lomb-enters-partnership-with-bosch-india.html https://biospectrumindia.com/news/97/8448/bausch-lomb-enters-partnership-with-bosch-india.html Thu, 18 Feb 2016 11:18:00 +0530 Bausch + Lomb entered into a partnership with Bosch. This cooperation brings together leading providers of eye care solutions and technology in India and SAARC region, to market technological advanced diagnostic devices in the ophthalmic segment. Bausch + Lomb will market Bosch's innovative digital Fundus camera - a compact retina camera, with special software that can detect conditions such as cataract at an early stage. Post signing the partnership, Mr Sanjay Bhutani, MD, India and SAARC, Bausch + Lomb, said, "Our partnership with Bosch is in line with our strategic expansion plans. With this collaboration, Bausch + Lomb will further strengthen its portfolio in the ophthalmic diagnostic devices market. Being a leader in the eye-care industry, this alliance will enable us to leverage our distribution strength to supplement growing market of eye care solutions." "To collaborate with 'Bausch + Lomb' is a motivating prospect as the company is renowned for its contribution to the eye-care field", said Mr Vijay Ratnaparkhe, MD, Bosch Engineering and Business Solutions. "At Bosch, we look to leverage this partnership as it would help us reach out to a larger population and thereby prevent the incidence of avoidable blindness and vision impairment in the country. Our constant endeavor is to leverage our technology expertise to develop innovative solutions that address the healthcare needs and challenges across countries." Digital Fundus eye camera operates on a rechargeable battery, thus making it lightweight and portable. The findings from the Fundus eye camera can be shared over tele-medicine using the MediBilder software. The automated detection algorithm can detect and mark conditions like diabetic retinopathy or glaucoma. These features allow for comprehensive eye screening at primary level and ensure better point of care services. In addition, the modularity of the device allows wider coverage of diseases apart from that of the retina. "Bausch + Lomb will continue to set new standards in eye-care by providing innovative technologies that help people see better", said Mr Premal Pandya, commercial director - ophthalmology and aesthetics, Bausch + Lomb, India.   "The partnership with Bausch + Lomb ties in well with Bosch's approach, as we look to create newer markets. This also includes sensitizing people about the problem of preventable blindness which has assumed disproportionate statistics in India," commented Mr Dattatri Salagame, VP-strategy, innovations and new business, Robert Bosch Engineering and Business Solutions, India.   ]]> https://biospectrumindia.com/news/97/8192/nice-recommends-medtronics-insulin-pump-systems-.html https://biospectrumindia.com/news/97/8192/nice-recommends-medtronics-insulin-pump-systems-.html Wed, 17 Feb 2016 12:16:41 +0530 The United Kingdom's National Institute for Health and Care Excellence (NICE) has issued positive guidance for the use of Medtronic insulin pump systems integrated with glucose sensors, for managing Type 1 diabetes and the avoidance of potentially life-threatening hypoglycemic episodes. The guidance reviewed two sensor-augmented insulin pump therapy systems and recommends the MiniMed Paradigm Veo system for managing glucose levels in people with Type 1 diabetes who experience 'disabling hypoglycemia' - defined as repeated and unpredictable occurrence of low-blood sugar attacks that result in persistent anxiety about recurrence, and is associated with a significant adverse impact on quality of life. Since the assessment of the MiniMed Paradigm Veo system in the Diagnostics Assessment Programme (DAP), NICE has recognised that in 2015, Medtronic launched a successor system, MiniMed 640G. The MiniMed Paradigm Veo and MiniMed 640G systems, are the only systems said to offer low glucose suspend mode, both incorporate continuous glucose monitoring (CGM) technology, providing users with a more complete picture of their glucose levels. The system alerts users when their sensor glucose levels are falling too low or rising too high, and also mimics the human pancreas' ability to suspend insulin delivery automatically - protecting against the risk of ahypo, even when a person is asleep or unable to react. Commenting on the guidance, Consultant Diabetologist of Harrogate District Hospital and ex-Clinical Lead for the NHS Diabetes National Insulin Pump Network, Dr Peter Hammond, said, "Avoiding episodes of severe or disabling hypoglycemia (hypos) can be one of the biggest challenges associated with managing Type 1 diabetes. Preventing hypoglycemic attacks, which put the lives of patients at risk and lead to costly A&E admissions and hospitalization, is a priority area for the NHS."   "The Medtronic system recommended by NICE incorporates sensor technology, continuously monitoring sugar and shutting-off insulin when needed, to reduce the risk of a hypo. Insulin pump therapy systems combined with continuous glucose sensing and automated suspension of insulin delivery can be a lifesaver for those who have lost the ability to recognise when they are experiencing a hypoglycemic episode, and are also very reassuring for parents of children with Type 1 diabetes who fear night-time hypoglycemia. This guidance is extremely positive; acknowledging the latest technology and confirming the vital role of sensor-augmented insulin pump therapy with automated insulin suspend in the effective treatment of Type 1 diabetes," he added. This diagnostics guidance supports the use of the MiniMed Paradigm Veo system for managing glucose levels in people with Type 1 diabetes if they have episodes of disabling hypoglycemia despite optimal management with continuous subcutaneous (under the skin) insulin infusion and Medtronic arranges to collect, analyse and publish data on the use of the MiniMed Paradigm Veo system and successor technologies with low-glucose suspend function.   ]]> https://biospectrumindia.com/news/97/4896/medical-devices-parks-get-ready-to-race-.html https://biospectrumindia.com/news/97/4896/medical-devices-parks-get-ready-to-race-.html Tue, 16 Feb 2016 16:47:03 +0530 As three states - Andhra Pradesh, Maharashtra and Gujarat - are racing ahead to establish exclusive world class medical device manufacturing parks, Association of Indian Medical Device Industry (AIMED), the apex body of medical device manufactures in the country has recommended eight key policy measures which must be rolled out to ensure the financial viability of these parks as well as to make India a super international hub for medical device manufacturing. AIMED recommendations range from tariff corrections to a new regulatory regime. Specifically AIMED has urged the government both at the Centre and states to ensure the following: (i) A separate Medical Device Regulatory Act and separate Rules with IHPRA - Indian Healthcare Products Regulatory Authority rather than proposed ongoing amendment to D&C Act with compliance audits by 3rd party certification and have a mandatory compliance and regulatory framework built on soon to be launched QCI certification to ensure Patient Safety. (ii)A medical device export promotion and India's first Import substitution council - MEDISEXPC (iii)A dept for Medical Devices, a Separate Ministry for Healthcare products to act as facilitator and regulator and coordinated plan between Central Government and State Governments to aid existing manufacturing clusters and new medical device parks.   (iv) Continued tariff correction to enable business viability. (v) MRP based tax as disincentive for high MRP to ensure consumer protection. (vi)Launch of a voluntary ICMED 13485 certification by QCI for enabling doctors and procurement agencies to have confidence in good quality medical devices. (vii) A 'Buy Indian' preferred market access policy for those manufacturers who have ICMED certification. (viii) A 15 percent preferential pricing online of World Bank and WHO tenders to support domestic manufacturers and counter 17 percent subsidy from China. "These policy rollouts would reduce our humungous import dependency quickly, create vibrant manufacturing eco-system and generate lakhs of high-value jobs within the country, something which we all want," said Mr Rajiv Nath, forum coordinator of AIMED. Mr Nath added that these policies are a must to make India a super global hub for medical device manufacturing and to boost up PM Modi's 'Make in India' vision. It may be known that the country has been struggling to reduce its heavy import dependency in a sector which is a critical component of national healthcare security. Besides, the high import dependency in this sector has been a stress point on country's foreign exchange situation as well as depriving high-value employment creation within the country. Currently, the medical device industry is estimated to be of Rs 30000 crore size with over 70 percent import dependency and nearly 90 percent import dependency in high-end electronic medical devices. The market at retail and institutional sale is expected to grow to over Rs 2,00,000 lakh crore by 2020. Thus if domestic manufacturing is not boosted, it will create multi-dimensional macro-economic and social security problems. Medical device was also among the top five priority sectors as part 'Make in India' roll out program. The government at the Centre has taken some appreciable measures to rekindle domestic manufacturing but certain critical policy and regulatory support are still not in place to translate good intentions into ground reality. Accordign to AIMED, these 8-point recommendations will go a long way to fill the gaps and vitalize the medical device manufacturing. AIMED has also submitted these recommendations to Shri Chandrababu Naidu, Chief Minister of Andhra Pradesh during their recent meeting with him in relation with the exclusive medical device park coming up in the state, with a request to use his good office and good relations with the Centre to work upon these recommendations to PM Modi. "I am all thankful to Shri Chandrababu Naidu for not only taking the lead in setting up country's first medical device park but also for assuring us that he will utilize his good office to ensure the success of medical device manufacturing by taking up industry's concerns at the appropriate platform," said Mr Nath. On behalf of industry, Mr Nath has also expressed his heartfelt thanks to Dr Jitendar Sharma, Advisor to AP Govt on Health & Medical Technology and also the head of Technology Division of NHSRC, Ministry of Health & Family Welfare, GOI for his proactive support for ensuring smooth setting of medical device park in the state having common manufacturing facilities to reduce capital expenditure for their project and offer low cost rentals and revenue support services to enable these units to be Competitive instead of the usual capital subsidy model .     ]]> https://biospectrumindia.com/news/97/8122/cloud-computing-to-drive-paradigm-shift-in-life-sciences.html https://biospectrumindia.com/news/97/8122/cloud-computing-to-drive-paradigm-shift-in-life-sciences.html Mon, 15 Feb 2016 15:16:25 +0530 The centre will provide expertise in cloud computing technologies and specific platforms including advanced Java, Spring, .NET, Python and statistical programming frameworks. Currently the facility employs more than 250 professionals including software engineers from prestigious institutions and scientists with doctoral degrees. This team is now building next-generation software, acting as an extension to Thermo Fisher's global software R&D teams. The software centre of excellence is Thermo Fisher's first such facility globally. According to the company's press release, cloud computing has the potential to significantly change lab workflows, and facilitate access to powerful data analysis techniques.   Mr Mark Field, VP & CTO, Thermo Fisher, who was in India on the occasion, told BioSpectrum, "The plan of erecting the centre has been realized after three years. Cloud computing and Internet of Things (IoT) are causing incredible disruptions across the world. The former has already made a stand in India. I have been in the software industry for 20 years, and India stands at the very forefront in making software and delivering the capabilities to the world. Software is a global phenomenon." Mr Amit Chopra, MD, VP/GM, Thermo Fisher Scientific India, added, "Indian scientists are adopting cloud computing technology, and the adoption rate is going to pick up rapidly. This technology enables scientists to leap forward in pioneering developments and be at the forefront." As a result of using cloud technology, something such as when a powerful genetic analysis software is released, it can immediately be deployed in the cloud, enabling scientific communities around the world to quickly and easily access the new capabilities. Mr Field added, "We have hundreds of users of this technology in India -- from prestigious institutes to commercial organizations -- and they are willing to experiment and play around a little bit before engaging in it fully. Cloud-based computing solutions have already been deployed in the US and Europe on a massive scale. This trend will soon catch up in India, and we are already seeing it coming." Cloud computing in the Life Sciences space is expected to make labs more productive and collaborative. "In the next 5 years, the cloud will become an innovation platform, much like the Internet. In the future, many incredible innovations and impossible things are going to come out of cloud usage," opined Mr Field. Through the cloud, thousands of labs and scientists are expected to get connected and act collaboratively, bringing in amazing capabilities and creating major paradigm shift in the Life Sciences space. "The cloud," Mr Chopra noted, "will change how scientists conduct research. We are providing them the platform to leverage and drive faster research solutions." According to Mr Field, it is way too early to predict the market size for cloud technologies. He said, "As scientific instruments become more and more sophisticated, the amount of data these instruments produce will far exceed the analytical capabilities or labs around the world. And scientists alone will not be able to manage all this data." Mr Chopra explained with an example how the cloud can be the point of origin for futuristic innovations. "Traditional fast-moving consumer goods (FMCG) and retail industries are being transformed by emerging ecommerce companies who have created entirely new business models. This is exactly what we are trying to do in the cloud space. In the next 10 or 15 years, we will see a radically transformed ecosystem in Science. The Internet, for example, transformed online education, opening up online classrooms, with world-class universities offering their programs to hundreds and thousands of students. Now we can envision the possibilities in scientific innovations that cloud computing can provide to Science," he said. ]]> https://biospectrumindia.com/news/97/7895/trivitron-launches-labsystems-diagnostics-ivd-factory-in-chennai.html https://biospectrumindia.com/news/97/7895/trivitron-launches-labsystems-diagnostics-ivd-factory-in-chennai.html Mon, 15 Feb 2016 10:38:41 +0530 Trivitron Group has launched Labsystems Diagnostics IVD Factory, an Indo Finnish joint collaboration; at Trivitron Medical Technology Park which is a 25 acres Medical Technology Park in SIPCOT Industrial Estate Chennai â€?to house multiple factories manufacturing variety of Medical Devices and Equipment under one campus. The Labsystems Diagnostics IVD Factory was inaugurated by Honorable Prime Minister of India, Shri Narendra Modi and PM of Finland, Mr Juha Sipilä and Dr GSK Velu, founder and managing director, Trivitron Group of Companies. Commenting on the occasion, Dr GSK Velu said, "We are extremely fortunate to have with us Shri Narendra Modi Ji, and Hon Prime Minister of India and Mr Juha Sipila Hon Prime Minister of Finland to declare open our new state of the art Manufacturing Facility built with Finnish IVD Technology from Labsystems OY Finland." He added, "Medical Devices industry is one of the biggest beneficiary of our Hon Prime Minster's Make in India initiative with several new initiatives being taken by Govt of India to bring this industry out of over 85 percent dependence on Imports. I am an ardent admirer of our Prime Minister's Make in India initiative and we are thankful to have our Prime Minister bless our inauguration event along with the Finnish Prime Minister to promote "Make in India" initiative in the Medical Devices segment. We will take this as a big encouragement to make more and more investments in own R&D and also Joint Venture Manufacturing initiatives in India." For accessing latest technology and making it available to a larger section on the population, Trivitron has acquired a very reputed Medical Device company named Labsystems Diagnostics OY, World No. 2 in the New Born Screening Technology apart from having core technology expertise in several products in the area of Laboratory Medicine.   The company have now done a "Technology Transfer" from their Finnish Company and created a State of the Art new facility capable of producing Biochemistry/ Hematology/ Point of Care Diagnostics/ Immunoassay, Mass Spectrometry Diagnostics Kits and Quality Control Sera in the Trivitron Medical Technology Park. This is the third manufacturing facility which will soon start commercial production in the Park. The park will manufacture First Ever Made in India New Born Screening System for the Nation and will make this technology accessible and affordable to the 27 Million Babies born in India slowly but steadily. Apart from New Born screening Kits the facility will be manufacturing high tech diagnostics kits first time in South Asia using Mass Spectrometry / Molecular Diagnostics/ New Generation Point of Care diagnostics platforms for various diseases and disorders in Women and Child Health area and Infectious Diseases diagnosis area. The new manufacturing facility will have the capacity to employ over 500+ people.     ]]> https://biospectrumindia.com/news/97/8079/wearables-and-big-data-in-healthcare-.html https://biospectrumindia.com/news/97/8079/wearables-and-big-data-in-healthcare-.html Thu, 04 Feb 2016 13:39:00 +0530 The Society for Clinical Data management announced its 2nd conference in India on the 11th & 12th of December, 2015. The conference was conceived around the idea of creating a platform for professionals from different spheres in the C.R.A.M.S industry to converge and share their expertise. This was also recognized by many attendees as a learning and development platform that gave insights on the currentindustry trends and latest updates in Clinical Research. India is now being identified as a pivotal point in contributions towards Data management. The conference theme was thus identified as "Innovations in CDM- Vision 2020: People, Processes & Technology". One of the session during the conference was 'Wearable Devices, Mobility & The Big Data Challenge' presented by KV Subrahmanyam. During his session he spoke about three user segments for wearable market. "There are currently three top user segments for the global wearable sensors market, security, healthcare, and fitness. Of these, healthcare and fitness are the two segments where wearables are gaining increasing acceptance. Some of the applications of wearables (wrist bands, smart clothing, smart contact lens, smart shoes etc) in this sector include remote patient monitoring, booking doctors appointment, 24*7 tracking/monitoring of senior citizens, constant health monitoring, sending critical alerts to the doctor, etc among others", he said. Wearable devices collect a host of information about the users (or patients as the case maybe). As the wearable devices are gaining more momentum and increasing adoption, these generate a lot of data, or big data. With the help of analytics, this big data can prove to be of greatest value and provide many useful insights such as, better patient recruitment for clinical trial, monitoring patient adherence, identification of undiagnosed patients, better disease pattern analysis, accelerating drug innovation, customised drug development etc. "Though big data provides opportunities, it also brings a great deal of challenges with respect to storage, access and security. The firms trying to leverage the potential of big data, have to overcome these challenges for successful implementation of the data", he added. The conference content was spread over 2 days with more than 200 delegates including about 40 speakers each with an expertise in a different domain, 2 keynote sessions from recognized experts in the clinical data management field, FDA video cast, panel discussion, leadership forum, thought leadership session and a student debate session. There was an equal opportunity for various components of thisindustry to put forward their views on the innovations in technologies that can impact the future of Clinical Data Management.     ]]> https://biospectrumindia.com/news/97/4129/india-is-the-silicon-valley-of-the-east-dr-kiran-mazumdar.html https://biospectrumindia.com/news/97/4129/india-is-the-silicon-valley-of-the-east-dr-kiran-mazumdar.html Wed, 03 Feb 2016 19:06:01 +0530 Bangalore hosted its first-day of the most anticipated three-day investors' event, Invest Karnataka 2016, a global meeting platform aimed at bringing biggest business minds and investors together to accelerate development through technology, innovation, inclusivity and sustainability. In one of the parallel sessions on Biotechnology sector, Dr Kiran Mazumdar, CMD, Biocon, delivered a presentation talking about India as a global innovation hub for the Biotech industry. She spoke about the exclusivity of Karnataka in the Biotech sector. "When I started Biocon, there were very few people who backed it up. It is not only Karnataka's rich human capital, but it has also created a very unique model - for every other State and other parts of the world - a close partnership between the industry, academia and the Government." She pointed that Biotech is an innovative sector which needs risk-takers. "Bangalore can boast itself as the Science and start-up capital because the city is full of first-generation entrepreneurs, which means you have plenty of risk-takers and this is enabling Bangalore to be the start-up capital of the country, not just in the IT sector, but also in Biotech. Innovation in Biotech starts with risk-taking. We need to ensure that innovation is unique, differentiating and path-breaking. This is what we expect start-ups to do, and we have large number of start-ups licensing their proprietary technologies to MNCs at premium values," she said. In India, 50% of all the Biotech companies are located in Karnataka, which has 19,000+ highly-qualified professionals, with 1000-plus R&D centers, and the State's Biotech sector contributing 30% of the national revenues. She took the audience through various eras of Indian Biotech in the last 4 decades. "The 80's was an era of enzymes followed by the vintage era of vaccines in the 90's. We produce largest number of vaccines in the world making India the 'Vaccine Capital' of the world. The year 2000 was the age of Internet belonging to genomics. The 2010's was the birth of biologics and biotech drugs, transforming the way diseases are treated. Low-cost and rich talent pool enabled India to develop world-class biologics addressing affordability and accessibility," she noted. Dr Kiran also laid emphasis on skill development, expertise and excellence. "When it comes to leadership, it's about building skills, expertise and excellence. You have to invest in building skills and scale. Companies started investing very heavily in building expertise. Many companies are setting up or outsourcing research services. This is a bigger investment opportunity," she stated. She voiced that Biotech is the new growth engine for the Indian economy. "Indian Biotech has recorded 20% CAGR in the last 10 years. The country has an ambition to realize Biotech revenues of $100 billion by 2025, which I think is achievable by enabling policies and regulations which will help build skills whether it is Biopharma, BioIT or enzymes," she commented. India is ranked 12th in the Biotech sector globally, and 3rd in APAC after China and Korea. She justified what makes India an innovation hub. "Low-cost of development, large network of academic institutions, availability of scientific and engineering talent, large pool of drug-naïve patients, genetic diversity of patient population enable different opportunities and have different strategies around clinical development," she said. She also said that India can serve as an attractive manufacturing destination. The Indian Government aims to spend $3.7 billion on Biotech between 2012-17, and the country has the 4th largest area under GM crops. India is also credited with having the 2nd highest number of USFDA-approved plants after the US, with manpower costs and the cost of manufacturing less than half compared to the West. Dr Kiran added that India's start-up ecosystem will depend on innovations coming out academic labs. "Institutions will rely on licensing incomes and royalties. Entrepreneurs should do their proof-of-concept and pre-clinical commercialization phase and add value to the innovation. The industry later should come up and commercialize products, enabling funding of the academic institutes and entrepreneurs by paying royalties," she observed. Karnataka was the first State in the country to introduce the Biotech Policy in 2001. "We have sound infrastructure and largest Biotech clusters in India, and sector-specific SEZs focusing on Biotech. We also have a comprehensive Biotech Policy and the Biotech Vision Group, with representations from the Government, industry and the academia," she remarked. She said that Bangalore is the Silicon Valley of the East. "In Biopharma there are huge opportunities for India, investors and organizations. We believe biosimilars market will touch $10 billion by 2020. Developing new drugs in India in Biotech is a $50 billion market, and the CRAMS a $40 billion market in the next four years. India has the potential to be the innovation hub for biosimilars and biologics. Global life sciences companies are looking at India as a CMO destination for many biologics, since India is a large and growing market for biologics," she concluded, quoting a Nobel Prize winner. 'Innovation consists of seeing what everybody has seen and thinking what nobody has thought.' - Dr Albert Szent-Gyorgyi ]]> https://biospectrumindia.com/news/97/8233/iot-healthcare-market-to-grow-at-43-cagr-during-2016-2022.html https://biospectrumindia.com/news/97/8233/iot-healthcare-market-to-grow-at-43-cagr-during-2016-2022.html Tue, 02 Feb 2016 17:13:19 +0530 Infoholic Research, a global ICT market research and consulting organization, recently published a study titled "IoT Healthcare Market- Global Trends and Forecast - 2016-2022". Infoholic Research predicts that the IoT solutions will have a positive impact on healthcare services, and with the government spending the healthcare delivery will improve. The research predicts the IoT healthcare market is expected to grow at CAGR of 43.01 percent for the period of 2016-2022. "IoT healthcare market has huge potential in developing regions. Asia Pacific is one of the largest and a high growth market, and it becomes important how healthcare organizations adopt technologies and applications to improve healthcare outcomes and reduce the overall cost of healthcare," said Mr Biswo Ranjan Bal, research analyst at Infoholic Research. Driving the robust CAGR growth of 43.01 percent is the foreseeable wide adoption of IoT solutions across regions. Most of the world's regions are facing a formidable challenge to manage the rapidly increasing cost of healthcare. Despite an overall focus on cost containment, some markets are projected to experience rapid spending growth as public and private healthcare systems develop. There has been the emergence of self-care where people want to care for their health via devices such as Nike Fuel band, Google Glass, and Fitbit, and with proper integration of technologies, the healthcare system will become incredibly connected in the next few years. Mr Tariq Shaik from Research Operations of Infoholic Research said, "Integration of wellness devices-consumer and regulated medical devices with the existing healthcare ecosystem will change the way healthcare business is done." The IoT healthcare market is divided into technologies and services. The technologies segment is again analyzed by network technologies and applications technologies. The network technologies are further segmented to short range technologies and long-range technologies, which are equally vital top form a connected ecosystem of healthcare. The service market is analyzed by consulting, integration and maintenance. The solution segment contributes to the majority of the market. The IoT Healthcare market is analyzed by providers, payers, bio-pharma and medical devices. The medical devices segment is further segmented to wellness devices-consumer and regulatory medical devices. The wellness devices - consumer holds the key to a major disruption in the healthcare industry. The IoT Healthcare market is divided into North America, Western Europe, Asia-Pacific (excluding Japan), Central Eastern Europe (CEE), Middle East and Africa (MEA) and Latin America. North America has the largest share of the market and these countries are the early adopters of these information systems. Asia-Pacific is one of the high growth markets which has immense potential for the market. The regions are further analyzed by countries in the region which influences major spending on healthcare in the particular region. ]]> https://biospectrumindia.com/news/97/8155/medtronic-acquires-renal-care-firm-bellco.html https://biospectrumindia.com/news/97/8155/medtronic-acquires-renal-care-firm-bellco.html Tue, 02 Feb 2016 11:09:48 +0530 Furthering its commitment to improve outcomes, expand therapy access, and optimize costs and efficiencies in end stage renal disease (ESRD), Medtronic announced it acquired privately-held Bellco, a pioneer in hemodialysis treatment solutions. Bellco's portfolio bolsters Medtronic's legacy renal access business and will be a foundational component of the company's recently formed Renal Care Solutions business. Bellco has created therapies and systems for the treatment of renal failure, multiple organ failure and sepsis. Bellco's full line of dialyzers and chronic and acute dialysis machines perform dialysis for adult, pediatric and neonatal ESRD patients. For more than 40 years, Bellco has offered advanced blood purification treatments for ESRD patients with chronic and acute kidney injury. The company's solutions are available in more than 50 countries. "ESRD patients require dialysis for the remainder of their lives, or until a viable kidney transplant becomes available. We believe Medtronic's Renal Care Solutions can offer better, more accessible and affordable solutions to the growing population of people living with ESRD," said Mr Ven Manda, president of Renal Care Solutions, Medtronic. "The integration of Bellco's portfolio of solutions will help further advance Medtronic's efforts to provide comprehensive care for dialysis patients worldwide." Medtronic acquired Bellco, an Italian-based company, from Charme Capital Partners, manager of the pan-European Charme Funds. Terms of the acquisition were not disclosed. "I believe Medtronic is an excellent opportunity for the Bellco team and ESRD patients worldwide. In four years, we created the ideal conditions to attract a global industry leader that is positioned to support Bellco's long-term growth strategy," said Mr Matteo di Montezemolo, founder and managing partner of the Charme Funds.   ]]> https://biospectrumindia.com/news/97/5504/boston-scientific-accenture-develop-data-driven-digital-health-solution.html https://biospectrumindia.com/news/97/5504/boston-scientific-accenture-develop-data-driven-digital-health-solution.html Mon, 01 Feb 2016 11:06:24 +0530 Boston Scientific Corporation and Accenture have developed a cloud-based, data-driven digital health solution for hospitals that is designed to help improve patient outcomes and reduce costs to treat patients with chronic cardiovascular diseases. The solution, known as ADVANTICS Care Pathway Transformation, is designed to enable providers to make more proactive and informed decisions based on insights into the patient population, ultimately improving the care a patient experiences from hospital stay through post-discharge care and in-home support. The Care Pathway Transformation solution uses the Accenture analytics insights platform, which provides actionable insights into care coordination and patient population health patterns, revealing opportunities to improve the consistency and efficiency of care coordination. The solution will focus on three key measurements: •Pathway Analytics: how a patient moves through the hospital system, how long each step takes and whether a patient can be better served by a more efficient system;•Care Management: how patients are diagnosed, treated and monitored, by whom and how often, as well as their ongoing vital signs and risk analysis; and•Patient Engagement: how patients are educated, monitored and receive communication during their hospitalization and after discharge.The solution has been tailored for insight into patients with heart failure, but the companies plan to expand it to additional disease states. In developing this solution, both companies worked with two of the largest hospitals in Scandinavia, Karolinska University Hospital in Sweden and Tampere Heart Hospital in Finland, to assess the current state of care delivery for heart failure patients and identify opportunities for improvement at each hospital. "Boston Scientific and Accenture designed this digital health platform to help providers standardize care, reduce overall length of stay and lower readmission rates," said Mr Mike Mahoney, president and chief executive officer, Boston Scientific. "The Care Pathway Transformation program is designed to enable healthcare professionals and patients to have more informed relationships, leading to better health outcomes and lower costs for health systems. Together, we are addressing an acute industry need for some of the most costly chronic conditions." Ms Anne O'Riordan, senior managing director at Accenture Life Sciences, said, "Socio-economic changes are driving the market to move to value-based care, and new data-driven care transformation services are a great enabler of delivering high-quality healthcare at the right cost. Working together with Boston Scientific, we are able to bring to market digital capabilities and analytics-driven insights that focus on improving patient and economic outcomes." ]]> https://biospectrumindia.com/features/97/7997/hottest-start-up-soldiers-against-drug-resistance-terror.html https://biospectrumindia.com/features/97/7997/hottest-start-up-soldiers-against-drug-resistance-terror.html Fri, 29 Jan 2016 18:01:00 +0530 Established in 2014, Bugworks is a drug discovery start-up involved in finding novel biopharmaceutical assets in treating antibiotic-resistant bacterial infections, using its proprietary systems biology platform. The start-up is actually a spin-off of Cellworks, a ten-year-old company focused on designing therapeutics using simulations to screen studies and predicting clinical outcomes, thereby increasing success rates and reducing R&D development costs. Cellworks is said to be the first company in India to use systems biology to study drug-disease interactions, and solving key issues in cancer drug discovery. It is an amalgamation of diverse areas such as mathematics, simulation, biochemistry and pharmacology in studying tumors, enabling creation of personalized medicine for cancer. Located in California, USA, and Bangalore, India, it was funded by investments from Artiman Ventures and Sequoia Capital. The genesis of Bugworks began at Cellworks while the team started working on infection portfolio. In 2013, the Cellworks team wanted to focus its attention on a large unmet medical need with high mortality rates. Their quest pointed them towards hospital-acquired infections.   These infections are picked up by people in hospitals through gram-negative bacterial contaminations, which are hard to kill and have greater drug resistance attribute. "Decades have passed by and drug resistant superbugs are becoming superior and smarter with higher mortality rates, with no available treatments to combat them effectively. Not many companies are working in this area, and we thought this would be the perfect stop for us to start," reveals Dr Anand Anandkumar, CEO, Bugworks, who also serves as the external director and chairman of the board of directors of the Cellworks' India operations. He says that patients are being bombarded with antibiotics for a certain period thereby bolstering the resistance rates causing a big void in finding new mechanisms fighting them. "Emerging countries are at the worst. India is a worst offender in the world. Antibiotic abuse happens in agriculture, poultry and medical stores because of their low-cost availability," he adds. Along with him, the company was co-founded by Dr V Bala Subramanian, serving as the president and Dr Santanu Datta as the chief scientific officer (CSO) of Bugworks, both of them hailing from a rich, two-decade-plus research experience at AstraZeneca India. While at AstraZeneca India, the former held major leading roles working on infection research and anti-bacterial drug discovery, the latter worked as a principal research scientist on infectious diseases with a focus on Malaria and Mycobacterium tuberculosis (MTB). Dr Anand continues, "The need is so bad because of the drug resistance in bacteria due to antibiotic abuse and lack of new drugs. The bugs have become used to existing drugs. There are not many drug discovery companies ready to invest in fighting the antibiotic-resistance." The last antibiotic widely used was Colistin, discovered in the 1950s. However, during the 70s, use of Colistin was stopped especially in the US because of its toxicity. "The last mechanism introduced for gram-negative bacteria was way back in the 60's. We have not had new antibiotic class for a long time," says Dr Bala Subramanian. Incubated at C-CAMP (Centre for Cellular and Molecular Platforms), Bugworks is located in Bangalore and Delaware, USA, employing close to 20 top-class professionals with diverse backgrounds. Bugworks' team also developed insilico model of MTB, and used it to identify new combinations for treating multidrug resistant tuberculosis (MDR) and extensively drug resistant tuberculosis (XDR-TB). Dr Bala explains, "The treatment for tuberculosis (TB) is a combination. We wanted to build a combination from all the existing available drugs in a rational manner. There are 18 different TB drugs, and we looked at 4 drug combinations, which led to 2 million combinations. This is where simulation comes to play. We built a computational model to probe all the 18 mechanisms and know the top combinations that can effectively arrest TB growth. We have had a successful collaboration with AstraZeneca in this regard, and now were able to identify 5 new drug combinations." The company has created a dynamic map of the bacteria, capable of exactly knowing where to block to stop its growth. "From that map, we can figure out where to block it with pinpointing accuracy," Dr Santanu voices. Dr Anand states that Bugworks will continue to work on TB but its focus will heavily be on hospital-acquired infections, and he says not much noise or awareness is made in this space. "We are looking for new mechanisms for antibiotics for gram-negatives, and new methods to prevent the formation of biofilms in medical devices," he notes. Biofilms are formed when microorganisms adhere themselves to the surface of objects, including medical devices. "In a way, we have a biopharmaceutical play, and potentially devices play too," says Dr Anand with excitement. In less than two years, Bugworks has bagged 4 grants - 1 international and 3 DBT-sponsored. "It has helped us with the cashflow in the company. We have won grants worth $300,000," he shares. The company, in 2015, was awarded as the 'Emerging Company of the Year' by ABLE (Association of Biotechnology Led Enterprises). At the moment, Bugworks has completed pre Series A round funding. "We will enter the market for Series A in about 12 months from now. The company has raised equity worth $2.3 million through angel investors," Dr Anand remarks. Bugworks is in in talks with large, world-class companies in the biopharmaceutical space for potential collaborations. "We are looking for collaborations with innovation-focused companies. Collaborations, for example, with big pharmas who can take our early proof-of-concept (PoC) and move up further. Our current collaborations are with universities, NCBS (National Centre for Biological Sciences) and a group in New York," opines Dr Anand. Dr Bala says that the company's expansion will purely depend on its partnerships. "It's too early to comment or forecast on our expansion. Firstly we want to take our offerings and make them available to population around the world. The 'where' and the 'how' depends on how we partner. Our products are not designed particularly for the Indian or Chinese markets. It's a global market out there." Dr Anand appreciates the start-up support offered by BIRAC (Biotechnology Industry Research Assistance Council). "We are proud to partner with BIRAC. They have been supportive of early-stage, high-risk and high-innovation companies with unique methodologies. The Government has been supporting very well, especially in the last 5 years. Without the DBT's support initially, Bugworks wouldn't exist today. The support was not just in terms of fundings but also the much-needed infrastructure as well," he expresses. According to Dr Anand, India has got talent on par with talent pool in Boston and Silicon Valley. "In the last few years, the ecosystem is getting stronger, compared to how it was 7 or 8 years ago. The only missing piece is we don't have good PEs, VCs or angels, who have the patience to put their money in this space. We have very few success stories in the country," he points. He emphasizes start-ups to have a strong, extraordinary team. "Everything boils down to the extraordinariness of the team. Up to series A, the funding purely depends on the strength of the team. It is good to have a 3 to 4-membered team from diverse backgrounds. Keep your eyes on the US markets, and having a founder who has good connections in the US is worth it. Entrepreneurs need to understand IPs, the problem they solve, its magnitude, the uniqueness of solution and the funding dynamics," he advices. He also adds that entrepreneurs need to have great patience and appetite for risk. "This is more like a marathon. At an individual level, being open to ideas and inputs coming in from all directions is important. One should be receptive to influences and possess tenaciousness. We have worked with very less or no salary at times. That's part of the risk appetite, or else it doesn't make sense to get into this game," Dr Anand clarifies. When it comes to the core team, Dr Bala says that it is not about the interplay of different skillsets. "We also bring in different emotional quotients, and a mix of optimism and pessimism as well. It is a heterogeneous group where we challenge each other. It's more than technical skillsets. It is also about emotional quotient," he mentions. For Bugworks, it took a year and almost 100 presentations to close its funding round. "Today investors are flocking towards food delivery and ecommerce start-ups. Nevertheless, we have a big opportunity at hand and seems very fulfilling scientifically, emotionally, socially, and financially. It's a social problem that we are solving. That's where it gets exciting," concludes Dr Santanu. ]]> https://biospectrumindia.com/news/97/7871/thermo-scientific-introduces-new-environmental-chambers-.html https://biospectrumindia.com/news/97/7871/thermo-scientific-introduces-new-environmental-chambers-.html Fri, 29 Jan 2016 10:54:37 +0530 Thermo Fisher Scientific introduces a new range of 230-volt environmental chambers, designed to provide highly stable environmental conditions, is now available in Europe, Africa, Latin America and the Asia Pacific region. The newly CE-marked range of Thermo Scientific Environmental Chambers provide temperature control above and below ambient for drug stability testing, shelf-life testing, insect studies or controlled storage. There are two models available in the range: the wide temperature units with humidity (available in 311 L and 821 L) and a heat-only model (available in 821 L) that is tailored for large-scale clinical applications and microbiology. For applications that require close control of a CO2 environment, there's an optional infrared CO2 package available that can be added to the wide temperature model. The interior of the environmental chambers is designed for stability. The horizontal laminar airflow system enables ideal temperature uniformity and fast recovery rates, which provide an optimal growth and testing environment, even with large product loads or heat-generating equipment. The environmental chambers feature a broad temperature range spanning from 0 to 60 degrees Celsius and the relative humidity is easily controlled to meet the needs of different applications. Importantly, the chambers meet certain compliance and regulatory requirements, including international conference on harmonization (ICH) guidelines for drug substance and product storage testing. "Thermo Fisher Scientific has sold environmental chambers for more than 25 years in the U.S., and we are thrilled to now introduce this product to Europe," said Mr Konrad Knauss, global product manager, Thermo Fisher Scientific. "Designed with the end user in mind, this series of environmental chambers is highly flexible and suited to a broad range of application needs, meaning that it fits a laboratory's needs now as well as in the future."   The rugged construction of the chambers promotes a long lifespan and provides a flexible and cost- effective solution for researchers. The chambers connect to standard monitoring systems for easy internal and regulatory product documentation and can be supplemented with accessories and options for many specific applications.   ]]> https://biospectrumindia.com/news/97/6329/lily-roche-partner-for-alzheimers-diagnostic-.html https://biospectrumindia.com/news/97/6329/lily-roche-partner-for-alzheimers-diagnostic-.html Fri, 29 Jan 2016 10:54:11 +0530 Eli Lilly and Company has announced an arrangement to partner with Roche Diagnostics on its ongoing development of a commercially scalable cerebrospinal fluid assay for amyloid-beta 1-42. Together with tau tangles, the presence of amyloid in the brain is a key marker of Alzheimer's disease, a condition with no cure that is estimated to impact more than 7.4 million Americans by 2025. Improving the ability of practicing clinicians to detect evidence of amyloid is an important step in being able to effectively manage the disease. Currently, healthcare providers can find evidence of amyloid in the living brain through two methods: a cerebrospinal fluid (CSF) test and an amyloid brain positron emission tomography (PET) scan. Under this non-exclusive agreement, Lilly is responsible for certain milestone payments upon successful completion of key development objectives. Roche is responsible for the development, registration, and commercialization of the new test. "We are excited to partner with Roche Diagnostics on this important test," said Ms Phyllis Ferrell, vice president of Lilly's Alzheimer's disease platform. "We share the same commitment to providing people with Alzheimer's disease the best care possible, which includes detection as well as diagnosis and education." ]]> https://biospectrumindia.com/news/97/8452/ap-launches-countrys-first-medical-device-park-at-arab-health-2016.html https://biospectrumindia.com/news/97/8452/ap-launches-countrys-first-medical-device-park-at-arab-health-2016.html Thu, 28 Jan 2016 12:46:22 +0530 With an aim to attract global interest and investment for its ambitious and country's first project of its kind, Andhra Pradesh Government launches "India's first dedicated medical device park for attracting investments at the prestigious "Arab Health Exhibition 2016, Dubai". The Exhibition take place from 25-28 January, 2016 at the Dubai International Convention and Exhibition Centre and was inaugurated by Mr Mohammed bin Rashid Al Maktoum the Prime Minister of the United Arab Emirates (UAE) and the Ruler of Dubai. AIMED has been invited for the formal launch ceremony in Dubai as part of the AP Govt Delegation led by Shri KV Satyanarayana the Andhra Pradesh Health Commissioner. Speaking at the occasion Shri Satyanayarana said, "There is a congenial environment prevailing in Andhra including best industrial policy, 24x7 power supply and 10 lac acres of land dedicated to industrial purposes. The recent Central Government announcement of withdrawal of duty concession on import of medical devices and the concession duty on raw materials is very timely for success of our project. This along with the National Medical Devices Policy on anvil will be complemented with our State led incentives to help make AP and India become a medical devices hub in the world." Shri Gopinath Mg Director of AP Medical Infrastructure Corporation said, "Andhra being the biggest market for medical devices and having large number of medical Colleges and super specialty hospitals is on its way to become the biggest medical hub in Asia. To achieve this objective we have planned dedicated infrastructure for medical device manufacturing faculties."   "We are pleased to be associated with the country's first medical device park. Arab Health Exhibition is a great platform to launch this project. It will assure global attention and interest and will go a long way in making this unique project a huge success," said Mr Rajiv Nath, forum coordinator, Association of Indian Medical Device Manufacturers (AIMED) It may be known that AP government has already earmarked 200 acres near Vishakhapatnam to build countries first and among the world's most advanced medical device manufacturing park. In a global first for any manufacturing park, this park will have a dedicated research, development and incubation centre to ensure that country becomes a global leader in chosen niche medical device verticals.   ]]> https://biospectrumindia.com/news/97/7749/medtech-industry-urges-authorities-to-replace-exclusive-fda-requirement.html https://biospectrumindia.com/news/97/7749/medtech-industry-urges-authorities-to-replace-exclusive-fda-requirement.html Thu, 28 Jan 2016 12:31:24 +0530 Domestic medical device industry has urged the Centre and States to do away with the insistence on USFDA approval in tendering process for public healthcare system and to replace it with more democratic options to eliminate discrimination against domestic manufacturers and to catalyze 'Make in India' mission. "Insistence on a Exclusionary USFDA certification requirement is a grossly discriminatory clause as it only favours large US companies in domestic public healthcare procurement process. This insistence is a pure absurdity and has resulted in exclusion of domestic manufacturers and manufacturers from other countries from bidding and hiking up the healthcare costs," said Mr Rajiv Nath. "No other country insists on only one certification and that also USA FDA and all major countries have their own domestic or alternate international certification e.g. Canada has CDMAS , Australia has TGA and Europe has CE. We have very competent manufacturers with European Certification or CE Mark Or it could be ISO 13485 certification from a reputed, competent and accredited Certification Body. USFDA could be an alternate option but why this insistence on only USFDA," added Mr Nath. "This insistence of US FDA Certification by reputed Indian Government Institutions like AIIMS and PGI Chandigarh, seriously undermines the credibility of our own Regulators. It also allows dumping of outdated products in India just because they are USFDA approved and denies the patients access to latest technologies offered by Indian Manufacturers" said Mr Gurmit Singh Chugh, MD, Translumina Therapeutics, manufacturer of Drug Eluting Stents. "I have attained more respect and acceptability of our products in Europe and other developed markets due to our high quality and clinical data but are treated "second grade" in our own country just because we manufacture in India and its not USA FDA approved."   Similar sentiments are expressed by Mr Vijay Paliwal, Managing Director, Janak Healthcare a reputed manufacturer of Hospital Beds ; Mr Rajesh Patel, Head Business Operations, Meril Life, Mr Prakash Teckchandani, Mr A Manickam, Director - International Relations & CSR, Trivitron Group of Companies and host of other domestic industry representatives. It may be known that many of Central and State run hospitals have made USFDA approval as mandatory in its tendering process for supply of medical equipments, despite the fact that there are many other equally competent certification that are used by the industry and countries around the world at large. But insistence for exclusively on USFDA has meant in-built planned bias in favour of large foreign companies as getting a USFDA is a lengthy, cumbersome and costly process and may not be needed by many manufacturers not targeting to access the USA market. Industry had long been advocating more options of certification/approvals including our own IC MED Certification as an equivalent to CE Mark or ISO 13485 so that tendering process becomes more democratic and participatory to enable wider open competition and a lower procurement cost . But a blind insistence on USFDA had resulted in award of contract only to select players till date and by implication discouragement to local manufacturing leading to India's increasing import dependency which is now over 70 percent. Thankfully, Moh&FW has realized this lacunae and the specifications under National Health Mission were corrected last year by NHSRC ( National Health System Resource Centre) to catalyze 'Make in India' mission and to make tendering process more inclusive and democratic. However still Central Govt and State Government and Defence establishments continue to ignore these specifications and guidelines. These are voluntary specifications and as yet have not become mandatory under any Regulation. Mr Nath has further advocated a 'Buy India Policy' in line with what many other countries including USA & China & Malaysia do to encourage domestic manufacturing.   "Many Countries have a Policy to encourage Domestic Manufacturing even USA has a Buy American Policy. Along with 'Make in India' Policy, it will be good if Indian Public Healthcare System has a 15 percent Price preferential 'Buy Indian Policy' or Preferential Market Access Policy in line with this and to counter the 17 percent subsidy of China on Export of Medical Devices," pointed out Mr Nath. The Task Force led by Dept of Pharmaceutical recommends a Preferential Market Access Policy but ironically here Indian Medical Devices manufacturers are still grappling against a Preferential Exclusionary Buy American Policy by Indian Healthcare Institutes.   ]]> https://biospectrumindia.com/news/97/7504/venaxis-announces-transaction-with-strand-.html https://biospectrumindia.com/news/97/7504/venaxis-announces-transaction-with-strand-.html Wed, 27 Jan 2016 16:56:46 +0530 Venaxis is an in vitro diagnostic company which has been focused on the clinical development and commercialization of its APPY1 Test, the company's rapid blood-based test for appendicitis. Strand LS is a privately-held, global genomics and bioinformatics company. Strand LS operates clinical reference labs in the US through its wholly owned subsidiary Strand Genomics (Strand U.S.) and directly in India, providing testing and lab services in India and other world-wide markets. Strand LS has commercialized a next generation sequencing (NGS) based, targeted, multi-gene, pan-cancer diagnostic panel in select international markets and has engaged in initial commercialization activities in the United States. Assuming participation by 100% of the Strand LS shareholders, the effect of the transaction will be that Strand LS shareholders and the employees and directors who are option-holders in Strand LS will own directly and beneficially approximately 68% of the combined enterprise and the current shareholders of Venaxis will own approximately 32%. Due to Indian tax and financial regulations, the transaction is being structured as purchases, by Venaxis, of the Strand LS shares from the Strand LS shareholders, followed by an immediate re-investment of those sale proceeds, by the Strand LS shareholders, into Venaxis Common Stock.   To comply with certain long-term holding period requirements under Indian tax law, the transaction is expected to be completed in two closings. The first closing will occur upon receipt of the necessary approvals from the Venaxis shareholders, receipt of all other required approvals and satisfaction of identified closing conditions. The second closing will occur approximately six months later. At each closing, Venaxis will enter into resale registration rights agreements with the Strand LS shareholders participating in such closing. The boards of each company have unanimously approved the transaction, however this transaction is subject to Venaxis shareholder approval. At the first closing, Venaxis will own a majority of the shares of Strand LS, will change its name to Strand Life Sciences, and will change its NASDAQ trading symbol.   As part of the first closing, following Venaxis shareholder approval, a Venaxis subsidiary will enter into an asset purchase agreement with Strand U.S. in which it will acquire substantially all of the assets and liabilities of Strand U.S. in exchange for cash consideration paid to Strand U.S. Advancing to the execution of the agreements with Strand LS, its shareholders and Strand U.S. represents the outcome of an extensive strategic process initiated by Venaxis in early 2015. Venaxis has also commenced, and expects to continue to attempt to locate a partner or other third-party interested in advancing development and or commercial activities of the Venaxis appendicitis portfolio. Aligning Strand Life Sciences' proven technological expertise in genomic profiling, bioinformatics and data curation with Venaxis' financial resources, NASDAQ public listing and key management personnel provides an opportunity for Strand Life Sciences to continue to commercialize its global business model towards what is believed to be a valuable enterprise for the combined shareholders. Following approval by the Venaxis shareholders and satisfaction of the other closing conditions, at the first closing, Dr. Vijay Chandru, the co-founder and current Executive Chairman of Strand LS, will serve as Executive Chairman of the combined company's Board of Directors, Steve Lundy will become the Chief Executive Officer of the combined company and Jeff McGonegal will continue as CFO. The initial combined board will consist of seven members with four from Strand LS and three from Venaxis. Commenting on the transaction, Dr. Vijay Chandru said, "On behalf of the Strand LS shareholders, we believe that this transaction represents an attractive opportunity for Strand Life Sciences, as an agile innovator in clinical genomics, to combine forces with Venaxis, a public company in the United States with experienced executives and board members to help it rapidly expand market adoption of StrandAdvantageTM and other future product offerings." "We are pleased to announce this transaction and are excited by the significant opportunity we believe it presents for shareholders of Venaxis and Strand LS," said Mr. Steve Lundy, Chief Executive Officer of Venaxis, Inc. "The combined company will benefit from Strand Life Sciences' 15 year successful history of technological expertise in genomic profiling, bioinformatics and data curation. Our initial focus will be to improve patient outcomes through the use of the StrandAdvantage pan-cancer gene panel, which was commercially launched in the United States in 2015. The combined company is expected to be focused on the continued commercialization of StrandAdvantage, as well as the development of additional oncology-related diagnostics." Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as joint financial advisors to Strand LS and Baker & Hostetler LLP is acting as legal counsel for Strand LS. Ballard Spahr LLP is acting as legal counsel to Venaxis. ]]> https://biospectrumindia.com/news/97/7375/perkinelmer-acquires-vanadis-diagnostics-ab-.html https://biospectrumindia.com/news/97/7375/perkinelmer-acquires-vanadis-diagnostics-ab-.html Wed, 27 Jan 2016 11:00:04 +0530 PerkinElmer announced that it has completed the acquisition of Vanadis Diagnostics, AB. Based in Sweden, Vanadis is developing a novel solution for non-invasive prenatal testing (NIPT) based on digital analysis of cell-free DNA. The acquisition is anticipated to build upon PerkinElmer's maternal fetal health offerings, which provide customers a full portfolio of traditional serum screening solutions. The Vanadis platform will enable PerkinElmer to offer a simplified, cost-effective, high-throughput approach to NIPT to help facilitate wider access for pregnant women. "While NIPT is becoming increasingly recognized as valuable to many high-risk expectant parents during the first trimester, test complexity and pricing issues have limited the ability of many biochemistry labs to effectively offer this type of prenatal screening," said Mr Prahlad Singh, president, Diagnostics, PerkinElmer. He added, "High capital investment, advanced molecular skills, and complex data handling for lab staff, along with the difficulty of integrating these systems into the existing screening infrastructure, have been barriers to more widespread adoption of NIPT. Vanadis' simplified NIPT platform, once available, should help overcome these obstacles, giving labs a wider range of prenatal testing capabilities and providing important information to physicians and patients." Adding Vanadis' capabilities to PerkinElmer's extensive diagnostics portfolio is intended to contribute to better health outcomes through improved detection of fetal chromosomal abnormalities. PerkinElmer's diagnostic offerings include: prenatal, neonatal and infectious disease screening, along with molecular diagnostics solutions, through its wide range of instruments, reagents and assay platforms, and software. The Company also provides private cord blood and cord tissue preservation to families through ViaCord LLC. "We founded Vanadis with the mission to make NIPT available to all women, and we developed this technology to fundamentally change the cost structure and workflow for NIPT," said Mr Olle Ericsson, CEO, Vanadis Diagnostics. "We are confident that with its leading position in prenatal screening, PerkinElmer is best situated to bring this system to market and address the under-served segment of average-risk pregnancies."   ]]> https://biospectrumindia.com/news/97/3231/sartorius-launches-new-automated-cell-culture-system-.html https://biospectrumindia.com/news/97/3231/sartorius-launches-new-automated-cell-culture-system-.html Mon, 25 Jan 2016 12:50:29 +0530 Sartorius launched the new SelecT Mk5 automated cell culture system for the routine production of high quality complex cell lines on Booth 1223 at the Society for Laboratory Automation and Screening (SLAS) Conference in San Diego, USA, held from Jan23-27, 2016. On the booth, the Sartorius team detailed how the new SelecT system has been extensively redesigned to upgrade its flask handling and pipetting capabilities, and now comes with an integrated Vi-CELL Cell Viability Analyser and a new Low Volume Reagent Dispensing module. They explained why this makes the SelecT Mk5 system an ideal choice for scientists looking for an established method of continuous, unattended large-scale culturing of reproducible assay-ready multiwell plates, and can also support the maintenance and expansion of cell lines requiring more complex handling, such as stem cells. The Vi-CELL was chosen for the new SelecT because the technology adapts well to the online automated measurement of cell viability and cell number required by SelecT. With the integrated Vi-CELL analyser, scientists can review numerical and image data in real time or while also having access to additional cell culture data provided by the SelecT system. The SelecT can use cell count data to automate media additions based on threshold values or seed new flasks with defined numbers of cells, providing a truly walk away cell culture system with a built-in feedback loop. The SelecT Mk5 system's new Low Volume Reagent Dispensing Option provides chilled storage for up to 6 different reagents and a new pipette adaptor allows 100µl-1ml to be aseptically dispensed into T-flasks. Using this feature, scientists can schedule SelecT to automatically add small quantities of expensive reagents, such as growth factors, and transfection or differentiation reagents, to their cell lines without having to load regents immediately before use. Dr Dave Thomas, SelecT Product Manager commented, "SelecT was introduced to the market 10 years ago, and over the past decade automated cell culture has changed. Scientists are now routinely culturing primary cells or stem cells that require constant monitoring, as well as the increasing use of high cost media components. By transferring the capabilities of our smaller scale cell culture system, the CompacT SelecT, to the larger SelecT platform, the system has evolved from simply supplying assay-ready plates to high throughput screening facilities into a system that can now support the cell culture tasks that our customers can see becoming more important over the next decade.".   Dr Thomas continued, "Following feedback from SelecT users, we have invested considerable resources and almost two years in developing this new system, which we're delighted to be introducing at SLAS. This investment in SelecT ensures the system can continue to support core cell culture facilities and users requiring large scale R&D cell culture capabilities. It also allows low or medium throughput facilities and users of our CompacT SelecT systems to seamlessly scale production to a larger system as their cell culture demands grow. For users wishing to transition R&D cell culture activities into more clinical applications, or for the production or biologics, many of the key design features that allow aseptic processing and cross contamination control are also present in our Cellmate automated cell culture system, that has been used in the manufacture of licensed products for the past 25 years. We look forward to welcoming scientists on Booth 1223 to discuss how the new SelecT Mk5 could help them produce consistent quality cell lines for a wide range of their drug screening applications."   ]]> https://biospectrumindia.com/news/97/7943/jj-to-cut-six-percent-of-medical-device-jobs.html https://biospectrumindia.com/news/97/7943/jj-to-cut-six-percent-of-medical-device-jobs.html Mon, 25 Jan 2016 11:06:31 +0530 Johnson & Johnson (J&J) has announced restructuring actions in its medical devices businesses to better serve the needs of customers and patients in evolving healthcare marketplace. The company is undertaking actions to strengthen its go-to-market model, accelerate the pace of innovation, further prioritize key platforms and geographies, and streamline operations while maintaining high quality standards. The company estimates that the actions announced will result in position eliminations of approximately 4 to 6 percent of the Medical Devices segment's global workforce over the next two years, subject to any consultation procedures in countries where required. Additional information regarding today's announcement can be found in the FAQ posted on www.investor.jnj.com/MDFAQ. Further commentary will be provided during the company's fourth quarter earnings conference call scheduled for January 26, 2016. The actions are expected to result in annualized pre-tax cost savings of $800 million to $1.0 billion, the majority of which is expected to be realized by the end of 2018, including approximately $200 million in 2016. The savings will provide the company with added flexibility and resources to fund investment in new growth opportunities and innovative solutions for customers and patients. In connection with its plans, the company expects to record pre-tax restructuring charges of approximately $2.0 billion to $2.4 billion, which will be treated as special items, of which approximately $600 million will be recorded in the fourth quarter of 2015. The company confirmed the full-year 2015 guidance it provided on October 13, 2015 for sales of $70.0 billion to $71.0 billion and adjusted earnings for the full-year 2015 of $6.15 to $6.20 per share, which excludes special items such as restructuring charges. The company's Consumer Medical Devices businesses, Vision Care and Diabetes Care, are not impacted by these actions.   "As a market leader, we are committed to leveraging our breadth and scale to shape the future of the medical device industry, for the benefit of those we serve," said Mr Gary Pruden, worldwide chairman, J&J Medical Devices. "The bold steps we are taking today are to evolve our offerings, structure and footprint and increase our investment in innovation. These actions recognize the changing needs of the global medical device market and will deliver more value to customers, increasing our competitive advantage and driving growth and profitability for our business."       ]]> https://biospectrumindia.com/news/97/7944/positive-bioscience-launches-rna-sequencing-test-for-cancer-.html https://biospectrumindia.com/news/97/7944/positive-bioscience-launches-rna-sequencing-test-for-cancer-.html Mon, 25 Jan 2016 11:06:16 +0530 Positive Bioscience announced the launch of its next generation product, Positive Select, a RNA sequencing test for Cancer treatment. Positive Select is the latest arsenal in fighting against cancer and is intended to aid Oncologists select the best treatment for cancer patients. Positive Select is based on whole RNA sequencing which is the latest technology available in the world and enhances the utility of comprehensive genomics profile manifold bringing Genomics test closer to clinical practice. With this Positive Bioscience becomes the first company in India to offer whole RNA sequencing test commercially for cancer. "By launching Positive Select, Positive Bioscience is again demonstrating its commitment to innovation and making cutting edge molecular information available to oncology community in India and worldwide," said Mr Samarth Jain, chief executive officer, Positive Bioscience. He added, "Cancer is driven by genomic alterations. Positive Select detects genomic alterations in all 25,000 genes and recommends treatment options with best probability of response as compared to recommendations based on testing of 4-5 genes through conventional testing. We expect that Positive Select will revolutionize molecular diagnostics in a way CT scan revolutionized imaging diagnostics when X Ray was a norm." "In this era of Precision Oncology, RNA sequencing is a recent advancement in diagnostic technology, offering the most comprehensive genetic information on various alterations and the level of expression on thousands of genes in a single step. The information can be used to select the best treatment option with least side effects," said Dr Amit Verma, consultant - molecular oncology and cancer genetics, Max Super Speciality Hospitals Saket, New Delhi. Positive Select is a comprehensive genomic solution for solid tumours(Lung Cancer, breast Cancer, Ovarian Cancer, Prostate Cancer, Sarcoma etc) as well as Haematological cancers(leukaemia, lymphoma, myeloma) designed to provide oncologists with clinically actionable report which can identify the molecular alterations in a patient's tumour and match those alterations with relevant targeted therapies and clinical trials. The test employs RNA sequencing to detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions.   Positive Select test results are provided in an easy-to-interpret report supported by a comprehensive review of published literature. Report provides treatment options with best probability of working in a particular patient based on cancer driving pathways and information on on-going clinical trials. Report also come with expression data of around 25,000 genes and thus is the most advanced test available in the world.   ]]> https://biospectrumindia.com/news/97/4031/syngene-q3-profit-up-31-revenue-up-23.html https://biospectrumindia.com/news/97/4031/syngene-q3-profit-up-31-revenue-up-23.html Fri, 22 Jan 2016 11:38:10 +0530 Biocon's contract research arm Syngene recorded Rs 281 crore revenue for the third quarter ended December 31, 2015 with a year on year growth of 23 percent. For the same period, company recorded Rs 51 crore profit with 31 percent increase over previous corresponding period. Commenting on the performance, Mr. Peter Bains, Executive Director and Chief Executive Officer - Syngene International Limited said, "Our Q3 results for FY16 saw a growth of 23% in revenues on the back of a sustained performance by all of our three business verticals - dedicated centres, discovery services as well as development & manufacturing services. This has helped us deliver revenues of Rs. 779 Cr. in 9MFY16, reflecting a YoY growth of 26%. I am also pleased to inform that we have successfully cleared another USFDA audit, which occurred in Q3 FY16. Our key capital investments are on track. The phase I of our new research centre is nearing completion, and will add significant capacities underpinning future growth. We continue to enhance and expand our service offerings to align with growing client requirements. The growth in Q3 FY16 was broad based across these three verticals, while being especially strong in the chemical development and discovery biology services. During the quarter, the company had one USFDA inspection of clinical development facility, which was successfully cleared with no 483s or major observations. Syngene has now successfully cleared five USFDA audits within the last three years. The phase I of Syngene Research Centre, comprising of 50,000 sq. ft. lab space, is scheduled to be commissioned in Q1 FY17. When fully commissioned, this centre will be a 200,000 sq. ft. versatile, state-ofthe-art research facility and will support integrated discovery programs in chemistry and biology. Other ongoing investments in various additional infrastructure are progressing on track and will be commissioned in the near to mid-term. ]]> https://biospectrumindia.com/news/97/7829/aimed-welcomes-duty-hike-on-imported-medical-devices-and-duty-reduction-on-raw-materials.html https://biospectrumindia.com/news/97/7829/aimed-welcomes-duty-hike-on-imported-medical-devices-and-duty-reduction-on-raw-materials.html Fri, 22 Jan 2016 11:10:53 +0530 The government's decision to hike duty on imported medical devices, re-impose SAD on such imports and reduction of taxes on raw material imports has been wholeheartedly welcomed by Indian medical device manufacturers. Thanking the government for this much desired and much awaited move, Association of Indian Medical Device Manufacturers (AIMED), has stated that the move will catalyze Prime Minister Modi's 'Make in India' mission as it brings to an end grossly discriminatory taxation regime against domestically manufactured goods which had resulted in making the country perilously import dependent in this critical sector and had also caused near decimation of domestic medical device industry. "The move is the first big boost to unshackle India from perilous import dependency in a critical sector. It will catalyze domestic manufacturing of medical devices and will go a long way in ensuring big success of PM Modi's 'Make in India' mission," said Mr Rajiv Nath, forum coordinator of AIMED. Ministry of Finance had communicated that Custom Duties on medical device have been increased from 5 percent (0 percent) to 7.5 percent and SAD of 4 percent have been re-imposed. The ministry has also limited Concessional Duty applicability to only 12 essential Medical Devices as opposed to a large number of Chapter 90 items which were enjoying this benefit. In addition, import duty on raw materials for the manufacture of medical devices has also been reduced. The earlier taxation anomalies had made imports far cheaper than domestically produced goods as taxation burden on domestic manufacturers were far higher. The earlier taxation regime which was heavily biased towards imports had resulted in significant cost differential between domestically manufactured goods and imports, making imports far cheaper. The net impact was serial closure of domestic units and making India dangerously import dependent. India has general import dependency of over 70 percent in medical devices and up to 90 percent in niche and electronic medical device segment.   "Nobody, neither the country, nor our people, nor the government nor the domestic industry was a gainer in earlier regime. It only ensured a secure exploitative market for importers and foreign companies, while making India perilously import dependent in such a critical sector," said Mr Nath. Foreign manufacturers were also not interested in setting up manufacturing units in the country as visualized under PM Modi's 'Make in India' mission as manufacturing here made little sense for them, added Mr Nath. "Now we can look forward to a vibrant domestic medical device manufacturing eco-system," said Mr Nath while adding that government now needed to focus its attention on few other remaining vexing issues if 'Make in India' is to be galvanized. AIMED has specially thanked Shri Hasmukh Adhia, Revenue Secretary; Shri V K Subburaj, Secretary, Dept. of Pharmaceuticals; Shri Amitabh Kant, Secretary, DIPP and Shri Bhanu Pratap Sharma, Secretary, Dept. of Health & Family Welfare for reversing the unfair taxation regime and contributing to 'Make in India' mission with this move. Talking about other vexing issues Mr Nath has drawn attention to flawed MRP regime, which is exploited by unscrupulous importers to artificially inflate price of imported medical devices and distort fair pricing regime in the country while leading to fleecing of unsuspecting and often hapless Indian consumers. He added that to stop artificial hiking of imported medical device Government should introduce an a CVD on MRP based criteria with abatement of at least 50 percent (in case one percent Excise Duty on MRP is not possible) to dis-incentivize Importers from passing on above artificial price hikes to Consumers. The above actions will surely help to make Indian Medical Devices Competitive and I am confident that many of us will pass on cost reduction of this benefit to the Consumers, added Mr Nath.   ]]> https://biospectrumindia.com/news/97/6781/parexel-to-acquire-health-advances-.html https://biospectrumindia.com/news/97/6781/parexel-to-acquire-health-advances-.html Thu, 21 Jan 2016 11:21:41 +0530 PAREXEL International Corporation has announced that the company has entered into a definitive agreement to acquire all outstanding equity securities of Health Advances, an independent life sciences strategy consulting firm. The acquisition is expected to close in February, subject to the satisfaction of closing conditions including expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Financial details of the transaction were not disclosed. Established in 1992, Health Advances employs approximately 120 scientists, clinicians, and business professionals in three main offices - two in the US and one in Europe. It works with more than half of the top 25 biopharmaceutical companies; the leading medical device, diagnostics, and health information technology companies; and healthcare investors and service businesses. Health Advances offers specialized services such as portfolio planning, product positioning, market assessment and forecasting, strategic and business planning, as well as advising on partnering and acquisitions. "Health Advances is a market-leading life sciences consultancy. Its innovative services, strong client relationships, and talented employees will complement our long-standing leadership in drug development, market access, and lifecycle management services for our clients," stated Mr Josef von Rickenbach, chairman and CEO, PAREXEL. "Health Advances will expand and strengthen our capabilities to meet the growing market demand for strategic portfolio- and product-level commercialization consulting. Clients will be able to engage with a single, global provider to fulfill all of their commercialization strategy and execution needs." "We are thrilled to be part of PAREXEL and offer clients a global presence, a larger range of services, and increased expertise in product and portfolio development. Together, we can maximize the value of our clients' product and service portfolios," added Mr Mark Speers and Ms Paula Ness Speers, Co-founders of Health Advances.   ]]> https://biospectrumindia.com/news/97/7452/trivitron-to-introduce-neomass-aaac-kit-at-arab-health-2016.html https://biospectrumindia.com/news/97/7452/trivitron-to-introduce-neomass-aaac-kit-at-arab-health-2016.html Wed, 20 Jan 2016 11:05:04 +0530 Trivitron Healthcare is set to launch its patented NeoMass AAAC Kit (CE Approved) for expanded panel of newborn screening (NBS), during the Arab Health 2016, the Middle East region's largest healthcare industry event, which will run from January 25th to 28th, 2016 at the Dubai International Convention and Exhibition Centre (DICEC). Released through its Finland subsidiary, Labsystems Diagnostics, the kit is the first-of-its-kind in the global market as it can detect up to 50 disorders that a newborn baby might be born with or without any immediate symptoms or visible manifestations--making it the broadest available panel of biomarkers. The launch of NeoMass AAAC Kit will make Trivitron a complete solution provider for NBS with Modular Systems, Automated Systems and Kits for core panel screening and Tandem MS/MS and NeoMass AAAC kit for expanded panel screening. The recently patented methodology makes it possible to detect deficiencies of all the six enzymes involved in the urea cycle metabolic pathway. The urea cycle is a metabolic pathway occurring in the liver and kidney and aberrant functions of the urea cycle enzymes lead to the buildup of ammonia, a product of protein metabolism. If not treated, the outcome is very serious with symptoms ranging from vomiting and increasing lethargy to respiratory distress and even coma and death. Additionally NeoMass AAAC enables an easy and reliable detection of type I tyrosinemia, a serious disease causing dermatologic and neuro developmental problems due to accumulation of tyrosine within the liver and kidney. Dr GSK Velu, chairman and managing director, Trivitron Group of Companies, said, "Trivitron Healthcare's Labsystems Diagnostics is one of the largest provider for newborn screening solutions in the world and our new patented NeoMass AAAC kit is the first kit in the world to detect up to 50 disorders. We, at Trivitron Healthcare, are privileged to announce the international launch of NeoMass AAAC Kit at Arab Healthcare 2016."   ]]> https://biospectrumindia.com/news/97/7873/agilent-extends-agreement-with-perkinelmer.html https://biospectrumindia.com/news/97/7873/agilent-extends-agreement-with-perkinelmer.html Wed, 20 Jan 2016 11:04:42 +0530 Agilent Technologies has announced an extension to its longstanding agreement with PerkinElmer, which supplies chips for Agilent's popular 2100 Bioanalyzer system. Since its introduction in 1999, the 2100 Bioanalyzer system has become an integral part of molecular biology laboratories around the world. It is used in DNA sequencing, gene expression, DNA fragment analysis, quality control for protein-based drugs, and other applications. "This agreement ensures that, for years to come, molecular biologists can continue to depend on the sample quality and high-fidelity data they obtain with the Agilent 2100 Bioanalyzer system," said Dr Knut Wintergerst, marketing and support manager for microfluidics at Agilent.   ]]> https://biospectrumindia.com/news/97/7459/healthcare-it-vc-funding-in-2015-plateaus-at-4-6-billion.html https://biospectrumindia.com/news/97/7459/healthcare-it-vc-funding-in-2015-plateaus-at-4-6-billion.html Tue, 19 Jan 2016 11:16:19 +0530 Mercom Capital Group, a global communications and consulting firm, released its annual report on funding and mergers and acquisition (M&A) activity for the Healthcare Information Technology (IT) / Digital Health sector in 2015. Mercom's comprehensive report covers deals of all sizes across the globe. Venture capital (VC) funding, including private equity and corporate venture capital, in the Health IT sector totaled $4.6 billion in 574 deals in 2015, slightly below 2014's record $4.7 billion in 670 deals - still a big year for the sector. Total corporate funding in Health IT companies including debt and public market financing (including IPOs) came to $7.9 billion this year, up slightly compared to $7.8 billion in 2014. As per the report, since 2010, the sector has received $13.4 billion in VC funding in 2,050 deals and almost $7 billion in debt and public market financing (including IPOs), bringing the total funding for the sector to $20.4 billion. "After an incredible run from 2010-2014, VC funding into Health IT companies leveled off last year. We are beginning to see a slow down in early stage deals, a sign the sector is beginning to mature. We are also seeing funding trends shift from practice-focused to consumer-focused technologies and products," commented Mr Raj Prabhu, CEO and co-founder of Mercom Capital Group. He added, "Apart from innovative technologies and solutions, business and revenue models are becoming more important." VC funding dipped in Q4 2015 with $1.1 billion in 145 deals compared to $1.6 billion in 148 deals in Q3 2015, says report.   Practice-centric companies raised more than $1.5 billion in 171 deals in 2015, down from $2.4 billion in 234 deals last year. Top funded areas included - Data Analytics companies with $294 million, followed by Clinical Decision Support companies with $220 million and Practice Management Solutions companies with $183 million. Consumer-centric companies grossed about $3.1 billion in 403 deals, up from $2.3 billion in 436 deals last year. Mobile Health (mHealth) companies raised the most funding with more than $1.1 billion. Most of the funding within the mHealth category went to mHealth Apps with $750 million and Wearables/Sensors with $277 million. Rating and Comparison Shopping companies received more than $1 billion followed by Telehealth companies with $468 million. The areas with the highest YoY growth in funding were Comparison Shopping with 615 percent, Scheduling and Appointment Booking with 370 percent and Wellness with 126 percent. The top VC funding rounds in 2015 were Chinese company Guahao's raise of $394 million, NantHealth's $200 million round, ZocDoc's $130 million raise, followed by Virgin Pulse's $92 million raise. India's Practo was next with a $90 million round, Collective Health raised $81 million and Health Catalyst brought in $70 million. A total of 909 investors participated in VC funding rounds for Healthcare IT companies in 2015 compared to 732 in 2014. The top VC investors in 2015 were New Enterprise Associates and Rock Health with nine deals each, followed by Merck Global Health Innovation Fund and Venrock with eight deals each. Mobile Health Apps had the most M&A transactions with 22, followed by Practice Management Solutions with 18 transactions, Data Analytics companies with 17, EHR/EMR companies with 16 and Telehealth companies with 11. There were seven Digital Health IPOs this year, raising $2.2 billion. Fitbit raised $841.2 million, followed by Inovalon with $600 million, Press Ganey Associates with $256 million, Evolent Health with $225 million, Teladoc with $180 million, MINDBODY with $100.1 million and Adherium with $25.6 million.   ]]> https://biospectrumindia.com/news/97/7543/aims-kochi-affiliated-as-nodal-centre-for-unesco-bioethics-for-saarc-countries.html https://biospectrumindia.com/news/97/7543/aims-kochi-affiliated-as-nodal-centre-for-unesco-bioethics-for-saarc-countries.html Tue, 19 Jan 2016 10:28:43 +0530 AIMS at Kochi has been appointed as the Nodal Centre for UNESCO Bioethics for SAARC countries. Dr N Dinesh from AIMS has taken charge as the Head, Kerala State, for the UNESCO Bioethics Network. The event to mark the occasion was attended by Justice JB Joshy, Chairperson, Kerala Human Rights Commission; Dr Prem Nair, Medical Director, Amrita Institute of Medical Sciences; Dr P Venkat Rangan, Vice Chancellor, Amrita University; Dr Russell D'Souza, Head, Asia Pacific Division of Chair of UNESCO Bioethics; Prof Dr OP Kalara, Vice Chancellor, Pandit BD Sharma University of Health Sciences, Haryana; and Prof Dr Arun Jamkar, President, Association of Indian Health Science Universities, along with Dr Mary Mathew, Head, National Training UNESCO Bioethics in Haifa and Dr A Marthanda Pillai, Coordinator, National UNESCO IMA Bioethics. The UNESCO Bioethics Network in collaboration with the Amrita Institute of Medical Sciences will study and develop curriculum for teaching, training and research in the field of bioethics (the field of ethical practice in medical and biological research), in order to address the lack of a composite bioethics structure in the SAARC countries. The mandate is to develop an up-to-date syllabus for medical ethics education based on the well-accepted core curriculum of the UNESCO, which would also satisfy the requirements of medical schools in a region.   The network offers opportunities to collaborate in research across countries in answering research questions in ethical issues, including areas that might have cultural and religious variations which could impact the method of teaching of ethics and the practice of ethics in clinical and other areas. It also offers opportunities for research in bioethics and trains senior teachers in bioethics using the UNESCO Ethic Teachers Training Course. The ethics syllabus aims to reduce incidents of ethical misconduct and malpractice by doctors who forgo ethical ways of practicing medicine. It attempts to raise the bar of ethical standards of upcoming medical practitioners and researchers so that they are more compassionate and understanding with patients and patients' families, and treat them with respect, compassion and care. "With over two thousand students currently enrolled in our schools of medicine, dentistry, pharmacy, nursing, and allied health sciences, we can ensure maximum impact with regards to the dissemination of ethical standards of practice and conduct in clinical as well as research areas. This will also help our students achieve worldwide projection", said Dr N Dinesan, the newly appointed Head for the Bioethics network at AIMS. The Indian medical education and health professional training program is the largest in the world with nearly 600 medical colleges and universities. The Indian Bioethics Program of UNESCO Chair has established a robust program with a network of bioethics units in government and private medical colleges. The Indian Medical Association and Medical Council of India are collaborating in the Chair's program of implementing a bioethics curriculum and providing training for teachers of bioethics. The Indian program has developed and piloted a culturally relevant bioethics curriculum based on the UNESCO Core curriculum that is being used in over 200 institutions worldwide. "The focus is on training our own students as well as students in SAARC countries in bioethics, which is an integral yet deeply neglected part of our field. Having an active program will benefit patients and their families in understanding the nature of their illness, and aid in making decisions periodically that address the complexity of the process of providing healthcare. We in SAARC countries are still very top down in our practice of medicine. "We dictate what a patient should or shouldn't do, and that robs the patients of their voice, and goes against the standards of ethical conduct. Having an expert committee designing and implementing strategies for ethical conduct and drawing the line when it comes to medical treatment -- that is, taking into consideration what the family and patient want - will help us set up a more egalitarian healthcare system," said Dr Prem Nair, Medical Director of the Amrita Institute of Medical Sciences. ]]> https://biospectrumindia.com/news/97/7415/clinical-research-stakeholders-welcome-positive-steps-hope-for-better-regulations.html https://biospectrumindia.com/news/97/7415/clinical-research-stakeholders-welcome-positive-steps-hope-for-better-regulations.html Mon, 18 Jan 2016 10:37:55 +0530 Besides welcoming various positive developments, the optimism for a better future for clinical research in India and patient access to more effective medicines was the overwhelming sentiment expressed at the 9th Annual Conference of the Indian Society for Clinical Research (ISCR) held recently at Mumbai. Over 400 clinical research professionals from across the stakeholder spectrum were drawn together to discuss and deliberate on the theme 'Clinical Research in India: Patients First and Research for India' and what more needs to be done to create a more enabling environment for the conduct of clinical research in the country. Ms Suneela Thatte, president, ISCR in her welcome address said, "We have seen a series of developments and order relating to clinical research in the country which has to a great extent helped bring balance in the regulatory environment. The compensation guidelines are more balanced and rational; we are beginning to see more predictable approval timelines with the expansion of the Subject Expert Committees; the expected roll-out of the accreditation process is projected to have a significant impact on the quality of research. We now have a regulatory system that is balanced, aligned with global trends and innovation and addresses our uniqueness as a country and society. This is a significant development, something that we at ISCR hope to build upon in 2016. It now extremely important not to lose sight of quality and compliance as the clinical research industry enters into the growth phase." A message was read on behalf of Dr K L Sharma, joint secretary, Ministry of Health and Family Welfare who could not join the conference, "The government of India understands the importance of clinical research in India and the industry concerns have been addressed substantially...In areas where we need improvement, the Government is willing to engage with industry stakeholders and academic or research institutions to work out solutions. We are committed to leverage the resources in the public and private sector to ensure cutting edge research in drug related areas," he said. The conference sessions touched upon topics such as clinical research operations, investigator initiated research, accreditation and understanding the functioning of US FDA advisory committee meetings as also on how technology is redefining the conduct of clinical trials and the use of electronics for the recording and management of health data. The highlight of the first day was an Industry-Academia Leader's Conclave which had representation from the heads of industry and academic institutions or hospitals in the country discuss the impact of the last few years on clinical research in India and what needs to be done in the next few bring clinical research in India back on track to meet the increasing burden of disease in the country. According to Dr Rajendra Badwe, director, Tata Memorial Hospital, "We need to ensure a permissive regulatory environment that is patient-centric. Improving patient outcomes is our first and foremost objective and we all collectively work towards ensuring that patients have access to latest therapeutic options for their unmet medical needs. In India, the perception that patients are being used as guinea pigs needs to change.""Our patients cannot be disadvantaged and need to get drugs at the earliest. In addition, we need a scientific temperament to be built in our country and an environment and enabling policy that will foster research," mentioned Mr K G Ananthakrishnan, MD, MSD India. Agreeing on the need to highlight the contribution of science to society, Mr Sharad Tyagi, MD, Boehringer Ingelheim, said that some fundamental issues like science and its perceived exploitation still need to be addressed and perceptions about science need to change in our country. "The challenges of the last few years have provided the industry an opportunity to change and innovate in a new regulatory environment. It also brought all stakeholders together on a common platform for the first time which augured well for the industry," opined Mr Naz Haji, senior vice president and CRO Head, Quintiles Research India. Panellists agreed that building trust and confidence in global stakeholders was an important requirement in bringing trials back to India while also highlighting that investigator and patient testimonials about the benefits of clinical research was also important in creating widespread awareness about the contribution of clinical research to better healthcare and patient outcomes. Industry stakeholders needed to take a more proactive role in building a more favourable environment for the conduct of clinical research in India which will enable and encourage local innovation and result in better and faster as well as more affordable and accessible treatment for patients in the country. The highlight of the second day was to understand the purpose of investigator initiated research in navigating the new environment for doing research in India. This session had representation from the heads of industry and academic institutions or hospitals in the country to discuss the changes in regulations and conducting research in times of uncertainty, the challenges faced by various stakeholders in carrying out multinational collaborative research and the value of repurposing drugs for current health needs. The final day concluded with the release of the findings of a research study done at the venue which saw more than a 75 percent participant response. The findings (which will be released to the media shortly) provided important and interesting insights on perceptions about the current external environment in India and what participants needed to be done to help rebuild a more enabling environment for clinical research in India. Close to 60 percent of the participants also renewed their pledge to commit to a more ethical clinical research environment in India in a booth that was sponsored by Sanofi India. The president of ISCR announced that the next ISCR Conference which will be the 10th edition will be held in Mumbai in January, 2017. ]]> https://biospectrumindia.com/news/97/6972/fda-clears-siemens-new-high-volume-coagulation-analyzer-.html https://biospectrumindia.com/news/97/6972/fda-clears-siemens-new-high-volume-coagulation-analyzer-.html Thu, 14 Jan 2016 11:58:42 +0530 Siemens Healthcare announces the FDA 510(k) clearance of the globally proven Sysmex CS-5100 System. This hemostasis system was the first to market with PSI technology globally and is now available to Siemens' US customers. The first analyzer in the Sysmex CS System portfolio of hemostasis solutions in the United States, this system is equipped with simultaneous multi-wavelength Preanalytical Sample Integrity checks, or PSI technology, enabling high-volume laboratories to achieve first-run accuracy. Leveraging globally proven PSI technology, the Sysmex CS-5100 System enables laboratories to automate and standardize sample management and detect unsuitable samples prior to analysis. This enhances the reliability of results while improving efficiency by minimizing the need for manual sample inspections.  "This new technology provides a strong operational advantage to customers, as they no longer need to manually inspect patient samples to ensure the correct volume prior to analysis," said Mr Franz Walt, president, Laboratory Diagnostics, Siemens Healthcare. "Available both as a stand-alone or complete workflow solution with connectivity to automation, the Sysmex CS-5100 System has the flexibility to meet varying testing-volume requirements." The Sysmex CS-5100 System also features third-generation cap-piercing technology, which contributes to reduced sample-processing time and maintains the analyzer's high-throughput capability. Further, greater efficiency is gained via a wide optical spectrum, which allows clotting, chromogenic, immunologic, and aggregation testing capabilities on a single platform. With onboard capacity of up to 3000 tests and up to 40 reagents, the Sysmex CS-5100 System delivers extended walkway time to streamline workflow.   To better ensure consistency of results and simplify testing in multisite labs, test results from the Sysmex CS-5100 System correlate with all other Sysmex CS and CA hemostasis systems. Additionally, the Sysmex CS-5100 System uses the same reagents, controls, and calibrators as other coagulation analyzers offered by Siemens.   ]]> https://biospectrumindia.com/news/97/7020/medtronic-launches-osteocool-rf-ablation-system.html https://biospectrumindia.com/news/97/7020/medtronic-launches-osteocool-rf-ablation-system.html Thu, 14 Jan 2016 11:58:01 +0530 Medtronic announced the US Food and Drug Administration (US FDA) 510(k) clearance and the US launch of the OsteoCool RF Ablation System. For physicians who treat patients with painful spine metastases, the OsteoCool System is the only cooled radiofrequency (RF) ablation technology that offers simultaneous, dual-probe capabilities - providing procedural flexibility and predictable, customized treatment. Cooled RF ablation uses targeted high-frequency energy to destroy cancer cells. "The OsteoCool System expands our Pain Therapies portfolio," said Ms Julie Foster, general manager and vice president of the Pain Therapies business in the Neuromodulation division, which is part of the Restorative Therapies Group at Medtronic. "Our customers treat patients with Kyphon Balloon Kyphoplasty who also have painful spinal metastases. The OsteoCool system gives physicians a way to treat that pain in a single procedure with a familiar, minimally invasive technique." In November, Medtronic received expanded indications for Kyphon Xpede Bone Cement, which now includes clearance for the treatment of microfractures that can be caused by cancer cells breaking down bone (forming osteolytic lesions). Where indicated, the OsteoCool Bone Access Kit can be used for a subsequent, physician-directed procedure such as cementoplasty (i.e., vertebroplasty or kyphoplasty). Medtronic acquired the OsteoCool technology and associated intellectual property from Baylis Medical on December 16, 2015 and partnered with the company to further innovate the system. Terms of the acquisition were not disclosed. The system is temperature controlled and uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure. The 17-gauge, bipolar probes are available in three lengths and may be used through a variety of cannula sizes. Because two OsteoCool RF ablation probes can be used simultaneously, the system supports a variety of ablation scenarios accommodating unique patient and procedural needs. The device is currently pending CE marking.   ]]> https://biospectrumindia.com/news/97/6449/samsung-india-inks-pact-with-haryana-government-.html https://biospectrumindia.com/news/97/6449/samsung-india-inks-pact-with-haryana-government-.html Wed, 13 Jan 2016 11:53:56 +0530 Haryana government and Samsung India has signed a pact to provide citizen hospital with high-tech equipment in Gurgaon worth about Rs 1.25 crore, says reports. Samsung India has come voluntarily to donate modern hi-tech machines to Citizen hospital, Gurgaon, under its Corporate Social Responsibility (CSR). "Given the large volume of patients at our government hospitals, we welcome support from companies such as Samsung in helping hospitals cater to the locals' need for quality health care," said Mr T L Satyapraksh, Gurgaon Deputy Commissioner, in a statement. Samsung has already started healthcare initiatives in Chennai, Mumbai and Bangalore and it plans to start its 5th initiative in Delhi, Samsung India VP Mr Rajiv Mishra informed.   ]]> https://biospectrumindia.com/features/97/7879/latest-bionic-eye-developments-indicate-bright-future-for-ocular-medical-devices.html https://biospectrumindia.com/features/97/7879/latest-bionic-eye-developments-indicate-bright-future-for-ocular-medical-devices.html Tue, 12 Jan 2016 16:09:16 +0530 The recent announcement by the Clinical Ophthalmology Research Group at the University of Oxford that two patients were able to achieve some restoration of vision following implantation of the Alpha IMS device puts maker Retina Implant AG ahead of the pack in the bionic eye space, according to research and consulting firm GlobalData. Mr Shashank Settipalli, GlobalData's Analyst covering Medical Devices, says: "These promising results, in conjunction with a string of positive developments for Retina Implant AG that included the CE mark and reimbursement approval in Germany for the first-generation Alpha IMS device, continue to bolster the company's standing in the burgeoning retinal prosthesis market." The Alpha IMS implant features an array of photosensitive electrodes, which replace the function of damaged or dead cellular photoreceptors. The device is implanted directly in the retina and is powered by a small, subcutaneous battery placed behind the ear. The analyst continues: "Retina Implant AG's technology has distinct advantages over Second Sight, its biggest competitor in the retinitis pigmentosa space, and maker of the Argus II system, which was approved nearly half a decade ago to offer some relief from ocular problems caused by the condition.   "Unlike the Argus II, the Alpha IMS device does not require an external camera or video processing unit. By leveraging these advantages and positive clinical results, Retina Implant AG has ample opportunities to expand its presence in the ocular devices space." Despite recent progress, visual impairment remains one of most debilitating indications under-addressed by the medical devices market. However, as more ocular devices gain regulatory and reimbursement approval in global markets, medical device firms have much to gain in a dynamic medical technology arena, according to GlobalData. Mr Settipalli concludes: "Start-up and mid-size ophthalmic device companies could appeal to investors encouraged by recent developments, whereas the larger multinational firms may seek new growth strategies through acquisitions and strong research and development efforts. "GlobalData anticipates sustained growth in the ocular devices market as novel technologies continue to attract attention for the foreseeable future." ]]> https://biospectrumindia.com/news/97/6422/medtronic-in-pact-admiral-deb-receives-ce-mark-.html https://biospectrumindia.com/news/97/6422/medtronic-in-pact-admiral-deb-receives-ce-mark-.html Tue, 12 Jan 2016 11:35:30 +0530 Medtronic announced that the IN.PACT Admiral drug eluting balloon (DEB) (also known as the IN.PACT Admiral drug-coated balloon (DCB) in non-European markets) has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. IN.PACT Admiral DEB aids in preventing restenosis, by opening the artery and delivering paclitaxel, an anti-proliferative agent, to the vessel wall. A new 40 centimeter catheter shaft will also be made commercially available in Europe under the expanded indication, which is specifically designed for AV access. In the United States, IN.PACT Admiral DEB is approved to treat superficial femoral and popliteal arteries. "IN.PACT Admiral DEB, a best-in-class therapy for the treatment of superficial femoral artery (SFA) disease, is now indicated in Europe for the treatment of AV access, providing a durable primary intervention that aids in extending time to re-intervention while preserving future treatment options," said Mr Brian Verrier, vice president and general manager of the peripheral business, within the Aortic and Peripheral Vascular division at Medtronic. "Improving lives and alleviating pain is a core piece of Medtronic's mission, and through IN.PACT Admiral DEB, we can help physicians treat patients with end-stage renal disease."     ]]> https://biospectrumindia.com/news/97/5394/thermo-fisher-scientific-to-acquire-affymetrix.html https://biospectrumindia.com/news/97/5394/thermo-fisher-scientific-to-acquire-affymetrix.html Tue, 12 Jan 2016 11:35:00 +0530 Thermo Fisher Scientific and Affymetrix announced that their boards of directors have unanimously approved Thermo Fisher's acquisition of Affymetrix for $14.00 per share in cash. The transaction represents a purchase price of approximately $1.3 billion. Affymetrix's technologies enable parallel and multiplex analysis of biological systems at the cellular, protein and genetic level, facilitating the transition of research tools into clinical and applied markets. The company's products are used by customers working in life sciences and translational research, molecular diagnostics, reproductive health and agricultural biotechnology. Based in Santa Clara, California, Affymetrix has approximately 1,100 employees worldwide and maintains sales and distribution operations primarily in the U.S., Europe and Asia. The business, which has annual revenues of approximately $350 million, will be integrated into Thermo Fisher's Life Sciences Solutions Segment. "The acquisition of Affymetrix will strengthen our leadership in biosciences and create new market opportunities for us in genetic analysis," said Mr Marc N Casper, president and chief executive officer of Thermo Fisher Scientific. He added, "In biosciences, the company's antibody portfolio will significantly expand our offering in the fast-growing flow cytometry market, and customers will have greater access to these products through our global scale and commercial reach. In genetic analysis, Affymetrix's technologies are highly complementary and present new opportunities for us in targeted clinical and applied markets. For shareholders, we expect the transaction to create value by generating attractive financial returns, including immediate accretion to our adjusted EPS." Mr Frank Witney, president and chief executive officer of Affymetrix, said, "Joining Thermo Fisher creates significant value for our customers, employees and shareholders. We will be able to build on our strong history of close collaboration with customers in our target markets by leveraging Thermo Fisher's deep relationships, particularly in biopharma, as well as their global scale and leading presence in Asia-Pacific. We are excited about the opportunity to combine our portfolios and strengthen our position in high-growth markets such as single-cell biology, reproductive health and AgBio. Our employees will benefit by being part of an industry-leading company, which brings many opportunities for career growth and development. We look forward to working closely with the Thermo Fisher team to ensure a smooth transition and integration." The transaction, which is expected to be completed by the end of the second quarter of 2016, is subject to the approval of Affymetrix shareholders and the satisfaction of customary closing conditions, including applicable regulatory approvals. Thermo Fisher intends to use cash on hand and short-term debt to finance the transaction.   JP Morgan is acting as financial advisor to Thermo Fisher, and Wachtell, Lipton, Rosen & Katz is serving as legal counsel. Morgan Stanley is acting as financial advisor to Affymetrix, and Davis, Polk & Wardwell LLP is serving as legal counsel.   ]]> https://biospectrumindia.com/news/97/5465/novartis-qualcomm-partner-for-breezhaler-inhaler-device.html https://biospectrumindia.com/news/97/5465/novartis-qualcomm-partner-for-breezhaler-inhaler-device.html Thu, 07 Jan 2016 10:53:33 +0530 Novartis announced a collaboration with Qualcomm through its subsidiary, Qualcomm Life in digital innovation with the Breezhaler inhaler device to treat COPD. Under this collaboration, Qualcomm Life will provide the technology solution for the connectivity of the next generation of the Breezhaler inhaler, a device used for Novartis' portfolio of COPD treatments of Onbrez Breezhaler, Seebri Breezhaler, and Ultibro Breezhaler, the leading LABA/LAMA treatment. This next generation of the Breezhaler inhaler will enable patients to have access to their own data on the use of their inhaler in near real time. The small, disposable and low power module contained within the inhaler device can detect and report usage, the time that the inhaler is used, as well as additional relevant information for patients and physicians. The module then wirelessly sends the data to the patient's smartphone and a Novartis COPD mobile application, which sends the data to the cloud, allowing patients and potentially their healthcare providers to monitor their COPD. The connected device will be ready for use by patients, with no assembly required. "Novartis supports patients being empowered to make it easier for them to manage their chronic conditions," said Mr David Epstein, head Novartis Pharmaceuticals. He added, "By enabling near real time data capture from the patient and the connected Breezhaler device, patients can monitor their own adherence to the medication they take which is vital to their health outcomes." Novartis aims to be the first company in respiratory medicine to offer a completely integrated, connected delivery device to provide a seamless, easy to use and simple experience for patients.   ]]> https://biospectrumindia.com/news/97/7924/cci-order-investigation-against-becton-dickinson-.html https://biospectrumindia.com/news/97/7924/cci-order-investigation-against-becton-dickinson-.html Wed, 06 Jan 2016 11:59:11 +0530 Competition Commission of India (CCI) has ordered an investigation against Becton Dickinson India for alleged anti-competitive practices with respect to healthcare services. Becton Dickinson, an MNC that makes disposable syringe under the brand name 'Emerald', has been accused for selling disposable syringe on higher MRP to hospitals and sell same product with lower price in open market. The Commission has ordered a detailed probe by its investigation arm Director General (DG) after finding "prima facie" case of contravening competition norms. According to the Commission, the informant is primarily aggrieved by the conduct of the opposite parties in charging a higher MRP for disposable syringe manufactured by Becton Dickinson India (OP 1) and brought from an in house pharmacy located within the hospital network of Max Super Speciality Hospital (OP 2). The price was found to be higher compared to MRP (Maximum Retail Price) of the same product in the open market.   "Prima facie, the Commission is of the considered opinion that the conduct of OP 2 in charging higher price, through printing higher MRP on disposable syringe in connivance with OP 1, from the informant amounts to imposition of unfair price," which is in violation of competition norms," CCI said. Ordering the probe, the Commission said that in case the DG finds that the opposite parties have violated competition norms, then the role of the "officials/ persons" who at the time of such contravention were in-charge and responsible for the conduct of the business, should also be investigated. For the complaint filed by one Mr Vivek Sharma, Competition Commission of India (CCI) considered 'provision of healthcare services by super speciality hospitals in Delhi' As per the order dated November 17, CCI is of the view that prima facie there is violation of Section 3 of the Competition Act that pertains to abuse of dominant position. CCI also noted that there is "no force in the arguments advanced by the counsels of OP 2 that DS available in the open market is different from the product sold by OP 2 in terms of packaging and its usefulness at the time of surgery".   ]]> https://biospectrumindia.com/news/97/7938/transasia-felicitated-by-minister-of-st.html https://biospectrumindia.com/news/97/7938/transasia-felicitated-by-minister-of-st.html Wed, 06 Jan 2016 11:58:34 +0530 At the recently held Association of Practising Pathologists (APP) National Pathcon and Lab Expo 2015, Mr Suresh Vazirani, chairman and managing director - Transasia Bio-Medicals was felicitated and commended for Transasia's 'Pioneer of Make in India Concept' initiative. This was bestowed by the Honorable Minister of Science and Technology and Earth Sciences, Government of India. Dr Harsh Vardhan, the Hon'ble Minister of India, acknowledged the role of the APP in the areas of Continuing Medical Education and Quality Assurance. He further appreciated their efforts in organizing CME activities and proficiency testing programmes, thereby helping a large number of medical laboratories in improving their services, ultimately benefitting the common man. The Association of Practising Pathologists founded in the year 2001, started with a 'dream and mission' of achieving high quality in all the diagnostic laboratories. It has been organizing its annual event in the form of PATHCON every year. This was the 2nd National Conference and was held at India Habitat Centre, New Delhi. The conference was attended by over 500 eminent and well-known doctors and practicing pathologists from various parts of Northern India. Transasia Bio-Medicals founded by Mr Vazirani, a true visionary, has led the organization for over three decades to become the largest Indian In-Vitro Diagnostic Company. It has pioneered the 'Make in India' initiative in 1991 with the indigenous manufacture of lab equipments and analyzers. Transasia now has three state-of-the-art manufacturing facilities in India for fully automatic random access analyzers, Elisa readers, HPLC system for HbA1c among other advanced products.     ]]> https://biospectrumindia.com/news/97/3980/bosch-invests-in-emperra-digital-diabetes-care-.html https://biospectrumindia.com/news/97/3980/bosch-invests-in-emperra-digital-diabetes-care-.html Tue, 05 Jan 2016 11:53:36 +0530 Emperra, a German start-up that has created a digital diabetes management solution consisting of smart hardware and software, has completed a Series B financing round of $3.1 million, with Robert Bosch Venture Capital GmbH (RBVC), a corporate venture capital company of the Bosch Group, joining the existing investors Peppermint Venture Partners and Investitionsbank des Landes Brandenburg. The funds will be used for further product development and to accelerate international growth, predominantly in the United States and Europe. With its flagship product ESYSTA, Emperra has debuted the first ever fully integrated digital diabetes management system. In it, key innovations such as smart insulin pens (usable with all major insulin brands), wireless blood glucose meters, and CE-certified software work together seamlessly. The therapy data can be shared among all stakeholders (patient, physicians, nurses, care givers including relatives) and displayed via multiple channels, including a web-based portal, smart TV, and apps. "ESYSTA provided us with compelling evidence of medical benefit in a study involving more than 200 patients," said Dr Dieter Kraft, an investment partner of Robert Bosch Venture Capital GmbH. "It was shown that mean glucose levels (measured as HbA1c) were significant lowered without increasing the potentially life-threatening risk of hypoglycemia". ESYSTA has already received reimbursement status from German health insurers, which means ESYSTA hardware and software is now available on prescription for any patient with diabetes. Initial success in the German market confirms the effectiveness of this fully integrated diabetes care management. "Digital health is poised to transform healthcare. With its data-driven therapy management, Emperra is excellently positioned to contribute to this transformation in the field of diabetes care," said Ms Gitte Bedford, vice president of Robert Bosch Venture Capital.   "Involving high-quality investors such as Bosch demonstrates the potential in our unique approach to diabetes care," said Dr Christian Krey, the CEO of Emperra. "In particular, having Bosch as a strategic investor means we have access to its global expertise in software automation, connected communities, and sensor technologies."     ]]> https://biospectrumindia.com/news/97/3370/syngenes-new-ceo-to-commence-office-in-mar-16.html https://biospectrumindia.com/news/97/3370/syngenes-new-ceo-to-commence-office-in-mar-16.html Mon, 04 Jan 2016 15:41:23 +0530 Mr Hunt will take charge as CEO post the retirement of current CEO Mr Peter Bains in March 2016. Mr Bains, who has worked closely with Syngene as a Director since 2010 and was appointed as the CEO in February, 2015 will continue as a member of the Syngene Board post his retirement. Commenting on the new appointment, Dr Kiran Mazumdar Shaw, Managing Director, Syngene International said, "We are extremely delighted to have Jonathan Hunt join the Syngene executive leadership team. After the resounding success of its IPO earlier during the year, Syngene is now at an exciting phase of its journey of transforming from a CRO to a full-fledged CRAMs player. Jonathan has a rich experience in the global biopharmaceutical industry and a proven track record of leading transformational change and delivering growth. We are sure, under his leadership, Syngene will continue to strengthen its position in the global CRAMs market." In his new role, Mr Hunt will be responsible for strengthening Syngene's relations with its existing global customers as well as forging new relationships. He will also steer the company's investments in developing and strengthening its capabilities and capacities to augment Syngene's service offerings.   Added Mr Peter Bains, CEO, Syngene International, "Syngene, with its differentiated strategy of multi model integrated Discovery, Development and Manufacturing capabilities, its expanding customer base and seasoned management team, is on a strong growth trajectory and very well positioned to continue this momentum. Jonathan's experience in building customer-focused organisations, coupled with his leadership and operational track record, make him the ideal selection for this position and we are delighted to welcome him aboard." Prior to Syngene, Mr Hunt had a long standing association with Astrazeneca where he held various leadership positions including President & Director of Astrazeneca, Austria and President & COO, Astrazeneca India. Earlier in his career he worked with Bayer Schering Pharma in various capacities. He holds a BA (Business Studies & Economics) from the University of Sheffield, UK and an MBA from Durham University, UK. Mr Jonathan said, "I am delighted to be joining Syngene at this exciting point in its journey. Syngene has a compelling business model, a track record of delivering operational excellence to its customers and ambitious plans for continued growth. I look forward to working closely with the Board, senior management team and leading the company to a new phase of growth." ]]> https://biospectrumindia.com/news/97/7421/health-minister-announces-4-new-it-based-initiatives-for-citizen-centric-health-services-.html https://biospectrumindia.com/news/97/7421/health-minister-announces-4-new-it-based-initiatives-for-citizen-centric-health-services-.html Mon, 04 Jan 2016 11:52:20 +0530 Shri J P Nadda, Union Minister for Health and Family Welfare announced four new IT-based initiatives on Good Governance Day, to mark the birth anniversary of Bharat Ratna Shri Madan Mohan Malaviya and birthday of Bharat Ratna Shri Atal Bihari Vajpayee. He was speaking at the launch of the AIIMS OPD Transformation Project which envisages the use of IT to provide ease to patients and citizens while accessing services at AIIMS. This is being supported by the Tata Consultancy services as part of their CSR initiative. Enumerating the first of the initiatives, the Health Minister announced 'Kilkari'. A major IT initiative, Kilkari is an audio-based mobile service that delivers weekly audio messages to families about pregnancy, child birth and child care. Each pregnant woman and infant's mother, registered in Mother and Child Tracking System (MCTS), a web- enabled name-based system to monitor and ensure delivery of full spectrum of services to all pregnant women and children, would receive weekly voice messages relevant to the stage of pregnancy or age of the infant. In the first phase of implementation, such messages would be sent to the pregnant women and infants' mothers in six States in Jharkhand, Odisha, Uttar Pradesh, Uttarakhand, and HPDs of Madhya Pradesh and Rajasthan. They are being developed in Hindi, English and Odiya languages in the first phase, to be later expanded to other languages to cover the entire country and would benefit over 2 crore pregnant women and 2 crore infants, annually. The Health Minister also stated that a new mobile-based application, Mobile Academy, has been developed through which about 9000,000 ASHAs will be trained using mobile services. This will aid in enhancing their inter-personal skills. Once registered, ASHAs can access the 240-minute course via their mobile phones. They can then complete the standardized course at their convenience. Digital bookmarking technology enables ASHAs to complete the course at their own pace. The course is divided into eleven chapters each containing four lessons. There is a quiz at the end of each chapter. ASHAs successfully completing the course by securing more than minimum prescribed marks will receive a Certificate of completion from the Government. As continuation of the Ministry's new IT-based initiatives, Shri Nadda informed about making the Revised National TB Control Programme (RNTCP) more patient-centric. A dedicated toll free number, 1 8 0 0 - 1 1 - 6 6 6 6, with a call centre is being started to provide round the clock support for patient counselling and treatment support services. This call centre will have trained personnel to provide feedback to patients and also link or refer chest symptomatic persons to RNTCP services. Under this initiative, callers can give a missed call or call to get complete support for diagnosis, treatment and support for the completion of treatment on the national toll free number, the Minister informed. This initiative is being started in the States of Punjab, Haryana, Chandigarh and Delhi.   Shri Nadda also announced 'M-Cessation'. This will be an IT-enabled tool to help tobacco users to quit tobacco. Built on a helpline concept, it will register beneficiaries on the basis of a missed call. The counselling would be done through a two-way SMS process, the Minister informed.   ]]> https://biospectrumindia.com/news/97/7135/neogenomics-completes-acquisition-of-clarient.html https://biospectrumindia.com/news/97/7135/neogenomics-completes-acquisition-of-clarient.html Fri, 01 Jan 2016 12:04:14 +0530 NeoGenomics has announced that it has completed the acquisition of Clarient and its wholly-owned subsidiary Clarient Diagnostic Services. Clarient, a provider of comprehensive cancer diagnostic testing to hospitals, physicians and the pharmaceutical industry, was a unit of GE Healthcare's Life Sciences business. The transaction purchase price included $80 million in cash, $110 million in Preferred Stock, and 15 million shares of NeoGenomics common stock. On a fully diluted basis, assuming full conversion of the preferred stock, GE Healthcare now owns approximately 32 percent of NeoGenomics. In addition, the Board of Directors of NeoGenomics will be expanded to include the appointment of a new director from GE Healthcare. NeoGenomics' chairman and CEO, Mr Douglas VanOort, commented, "We are very pleased to welcome each of our new employees to the NeoGenomics family, and to begin to add Clarient's outstanding capabilities to our strong service offering. The support of Clarient's employees and clients for our acquisition has been tremendous, and we appreciate the overwhelming support for the transaction by NeoGenomics shareholders. Clearly, the acquisition of Clarient is a major step forward in achieving our vision to become America's premier cancer testing laboratory."     ]]> https://biospectrumindia.com/news/97/3477/practice-safe-injection-regime.html https://biospectrumindia.com/news/97/3477/practice-safe-injection-regime.html Fri, 01 Jan 2016 12:03:28 +0530 Safe injection practice lowers the burden of disease and overall healthcare cost. HMD has been an active partner in global initiatives for moving towards a safer injection practice regime and has inculcated this as part of its CSR program. Introduction and Identification of Problem:Syringes should be life giver, not life taker. But sadly this has not really been the case as unsafe injections continue to be a major problem threatening patient's life, casting shadows over immunization programs and raising overall healthcare cost for both individuals as well as countries. According to WHO, every year at least 16 billion injections are administered worldwide. The vast majority - around 90 percent - are given in curative care. Immunization accounts for around 5 percent of all injections while the remaining indications include transfusion of blood and blood products, intravenous administration of drugs and fluids and administration of injectable contraceptives. Unsafe injections can result in the transmission of blood-borne pathogens from patient to patient (through reuse of syringes), patient to healthcare worker (through needle-stick injuries) and more rarely, health worker to patient. The community at large is also at risk when used injection equipment is not safely disposed of. Unsafe injection practices have also been the cause of outbreaks of viral hepatitis B and C and HIV in healthcare settings including in high income countries. Unsafe injection practices are also associated with substantial morbidity and mortality. Before safe injection campaign first began in year 2000, it was estimated that up to 1,60,000 human immunodeficiency virus (HIV), 4.7 million hepatitis C and 16 million hepatitis B infections each year are attributable to unsafe injection practices. The problem was complex and fuelled by a mixture of socio-cultural, economic and structural factors.   Even a recent study by Miller & Pisani concluded in 2014 found that in 2010 as many as 33,800 people became infected with HIV, up to 1.7 million were infected with hepatitis B virus and up to 3,15,000 with hepatitis C virus through an unsafe injection! Another study estimated that more than 1.3 million deaths annually and USD535 million in avoidable expenses are estimated to be due to unsafe injection practices. India Specific Problems: Practice of unsafe injections has been quite prevalent in the rural areas, which is home to over 65 percent of our population. One of the largest epidemics of acute hepatitis occurred in February-March 2009 in the Sabarkantha district of Gujarat in India, with 456 cases and 89 deaths. The center of the outbreak was Modasa taluka. All the victims gave history of receiving injections about 2-3 months prior to the development of clinical signs and symptoms from one particular doctor. Gross and continued use of contaminated injection devices led to this explosive outbreak with such high mortality. The particular doctor was caught and found guilty of such practices. A study conducted by CLEN Program Evaluation Network on behalf of Ministry of Health, Government of India and the World Bank (2002-2004), revealed that around 65% of syringes used in the country were not disposed or sterilized, and often reused. Still, the true extent of the practice of unsafe injections has neither been fully documented nor studied across states, mainly due to resource constraints and lesser appreciation of the problem by various governments. Nonetheless, it is safe to conclude that the practice of unsafe injections was widely prevalent in India and continues to be practiced widely in some pockets. Government of India has been aware of the problem but has also been slow to mandate the use of safe injection practice, which in practice means compulsory use of AD syringes for all kinds of injections. It was only in July 2014 that the Union Ministry of Health launched a 'Handbook of Guidelines for Safe Injection Practices' to promote awareness about the benefits and use of AD syringes. Subsequently, the National Health Resource Centre of Ministry of Health conducted an HTA (Health Technology Assessment) which substantiated the need to use Auto Disable Syringes for curative and immunization injections as appropriate technology to prevent noscomial infections. However, the implementation of government's advisory for use of AD syringes for therapeutic injections has been half hearted in India despite periodic reminders. It is hoped that with new advocacy campaign, there will be increased awareness for more responsible health practices which also brings down overall health spending and average days of stay at health centers. This fact has already been substantiated in countries like Uganda, Tanzania, and Nigeria which saw sharp drops after large scale adoption of AD syringes and mandating it for over 90 percent of injections. Global Initiatives towards Safe Injection Practice: Substantial efforts to address unsafe injection practices have been made by WHO in collaboration with the Safe Injection Global Network (SIGN) and UNICEF and other key international health players such as GAVI since 1999. WHO, with the support of SIGN developed and assisted countries in implementing a strategy with three pillars consisting of behaviour change among patients and health-care workers aiming to reduce unnecessary injections and ensure safe injection practices, (ii) increasing the availability of high quality injection devices and (iii) implementing a sound sharps waste management system. In order to implement the second component of the strategy, WHO, UNICEF and UNFPA issued in 1999, a joint policy statement recommending to all countries the exclusive use of auto-disable syringes (ADs), which allow only single use, for all immunization injections by 2003. Gavi, the global vaccine alliance, formed in 2000 with initial USD 750 million pledge from the Bill & Melinda Gates Foundation for the purpose of ensuring equal access to vaccination to children cutting across geographies and income divide, started using and advocating disposable syringes for immunization purposes. The WHO mandate for Auto-Disposal syringe regime is the largest preventive healthcare initiative that has been seen in a long time. Under the new initiative, WHO and partners have urged that all countries should transition by 2020 to the exclusive use, where appropriate, of WHO prequalified (or equivalent) safety engineered injection devices including reuse prevention (RUPs ) syringes and sharps injury protection (SIPs) devices for therapeutic injections in healthcare settings and develop related national policies. HMD's Advocacy and Association with Safe Injection Campaigns: Hindustan Syringes & Medical Device Ltd (HMD) is the only Indian coalition partner of SIGN (Safe Injection Global Network) and for years has been an active campaigner for safe health practices in the interest of both patient as well as health workers. For the latest WHO initiative, HMD was specially invited by the WHO at the launch function at Geneva and has been made a knowledge partner for this initiative in India. We are also committed to the GAVI-Star vaccination alliance for matching funding mechanism, which is an innovative way to increase immunization accessibility and safe injection to underprivileged children. HMD through its CSR Wing, SAFE POINT INDIA remains committed to continue to contribute towards the cause of educating uninformed public on the dangers of receiving unsafe injections and unsafe waste disposal. As pointed out earlier, syringe re-use is the main source of cross-infection in the developing world, infecting innocent people with blood-borne diseases such as HIV and Hepatitis B and C. SAFE POINT INDIA was set up in the year 2006 in New Delhi with the objective of enhancing awareness about the injection safety health & hygiene by running public awareness campaigns targeting both healthcare workers i.e. nursing professionals, doctors and other paramedical staff along with the general public starting from school going children at the impressionable age. Since 2006 SAFE POINT INDIA in Delhi has successfully conducted over 36 Safe Injection Awareness Programs covering hospitals, community centres, schools etc. Apart from this, there is regular participation in Perfect Health Mela at Delhi organised by Heart Care Foundation of India, which is daily visited by about 3,50,000 visitors during the Perfect Health Mela days. There has been regular participation in exhibition in different parts of the country by Safe Point India. Injection Safety Week is organized in November in various cities of India. In one of the Injection Safety Week in Mumbai daily commuter were educated in Chhatterpati Shivaji Railway Station. The surest way to protect against unsafe injections is to use injection devices that have been engineered so they cannot be re-used and doesn't lead to accidental needle stick injuries among health workers.   ]]> https://biospectrumindia.com/reports-white-papers/97/8370/sky-is-the-limit.html https://biospectrumindia.com/reports-white-papers/97/8370/sky-is-the-limit.html Wed, 30 Dec 2015 11:34:49 +0530 3B BlackBio is an R&D based Indo-Spanish joint Venture company and is dedicated to develop innovative products to be used in biotechnology;mainly lifesciences and molecular diagnostics. The firm clocked a total revenue of Rs 1.01 crore in the financial year 2014-15, a slight increase of seven percent from Rs 0.94 crore in the fiscal 2013-14. However, the firm is eyeing a growth of 150 percent in the present fiscal. The firm's future plans include creating awareness of Molecular Diagnostics (MDx) and simultaneous creation of network of molecular diagnostic centres (franchisee based) in secondary towns to make molecular tests affordable to masses,to develop PCR kits for key Oncology parameters, with affordability as main object. ]]> https://biospectrumindia.com/reports-white-papers/97/7259/biohouse-faces-sluggish-market.html https://biospectrumindia.com/reports-white-papers/97/7259/biohouse-faces-sluggish-market.html Wed, 30 Dec 2015 11:23:13 +0530 Rank: 12Segment: BioSupplier-DistributorOrganization: Biohouse Solution CEO: Mr Rupinder Singh Revenue: Rs 9.91 crore   Biohouse Solution is a biotechnology supplier company that serves the healthcare institutions, life science researchers, clinical laboratories, and the pharma and biotech industries. It purposes to provide the best reagents and ingredients for the biotech and pharmaceutical sectors. Its business segments includes cell biology, pharmaceutical, molecular biology, diagnostic healthcare, and cell nutrition.Biohouse is headquartered in Gurgaon and has offices in Chandigarh and Hyderabad. It also has presence in Bangladesh, Pakistan and Sri Lanka through its channel partners. According to Biohouse's CEO Mr Rupinder, the life sciences market has remained sluggish for the last two years. He along with Mr Jimmy Bhambra head Biohouse Solution. Some of its clientele includes Ranbaxy (Daichii India), Biocon, Indswift labs, Swiss Garnier, Alembic, Acme Labs, Chimak health care, Baksons Homeopathy, Dabur, Panacea Biotech, Institute of Genomics and Integrative Biology (IGIB), National Institute of Immunology (NII), All India Institute of Medical Science (AIIMS), Central Drug Research Institute (CDRI), Sanjay Gandhi PostGraduate Institute of Medical Sciences (SGPGIMS), Institute of Microbial Technology (IMTECH), Apollo Hospital, Medicity, and Batra Hospital. The channel partners and their products that have been represented by Biohouse are Adam Equipments for weighing scales, moisture balances, balances and mass measuring equipments; Biohit for liquid handling products; Becton Dickinson Biosciences for antibodies, flow cytometers, tissue culture, and general plasticware; MP Biomedicals for life sciences, fine chemical and diagnostic products; Kerry Biosciences, Sheffield Pharma Ingredients, and AES CHEMIUNEX for microbiology tools; Roche Diagnostics for molecular biology and diagnostics products; Gen Chemical Corporation for manufacturing vaccine adjuvants; and Accelrys for bioinformatics and molecular modeling software. Prior to founding Biohouse Solution, Mr Rupinder was working as the Asian regional director for Kerry Bioscience. He has also worked as business manager for BD Biosciences. For FY 2013-14, the company recorded revenue of Rs 9.91crore. Four years ago, in FY 2009-10, the company reported revenue of Rs 7 crore. ]]> https://biospectrumindia.com/reports-white-papers/97/8494/one-stop-shop-biolinx.html https://biospectrumindia.com/reports-white-papers/97/8494/one-stop-shop-biolinx.html Wed, 30 Dec 2015 11:16:26 +0530 Rank: 11Segment: BioSupplier-DistributorOrganization: Biolinx Labsystems CEO: Mr Mittal Gor Bioscience Revenue: Rs 16 crore   Biolinx Labsystems provides complete lab solutions, positioning itself as a one-stop-shop for sourcing, procuring and consolidation to helps its clients save time, resource, and money. The company specializes in sourcing quality lab products from top manufacturers for complete warranty assurance. It offers direct dispatch from manufacturer's premises or in consideration with its freight forwarding agents. The year 2014-15 was another landmark year for Biolinx in terms of growth. Inspite of overall slowdown in research funding,it grew substantially. It has been awarded as the 'Excellent Performer in Laboratory Equipments'with a Gold Award trophy for overall sales in India, by Thermo Scientific for the last three consecutive years. It was also honored as the 'Key Channel Partner' from Bio-rad Laboratories for outperforming the sales numbers in the segment of life science gadgets and consumables. Pharmalytica 2015 awarded it with a trophy for the category of best marketing activities, thus adding one more feather in the list of achievements. One of its key strategies includes providing timely services and giving customers a peace of mind by taking care of all issues related to instruments. It also creates a customer segmentation model based on factors including requirement, profitability, growth and importance of the business. Biolinx ensures functional departments are structured appropriately to support growth of the business. Venturing into capital niche market products for life science market also serves as one of its strategy. A wide range of products were introduced by the company during the year which includes fermenters, automated glassware washers, flame photometers, multi angle light detection systems (MALS), field flow fractionation Systems (FFF), chlorine di-oxide fumigation systems, liquid-solid biowaste systems, vacuum homogenizer, viscometer, rheometer, refractmeters, density meters, and titrators. Under the leadership of Mr Mittal Biolinx registered almost an average growth of 40 percent per year. Mr Mittal says that currently the market trend is more towards manufacturing of stable biopharmaceuticals and formulation products. The company this year has also set up of an entire R&D facility for Reliance Industries. It has received major orders from Zydus Cadila, Lupin, National Institute of Pharmaceutical Education and Research (NIPER), BV Patel Pharmaceutical Education and Research (PERD), Bhabha Atomic Research Centre (BARC), Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute (KDAH), and National Centre For Cell Science (NCCS). ]]> https://biospectrumindia.com/reports-white-papers/97/7257/securing-the-success-sisco.html https://biospectrumindia.com/reports-white-papers/97/7257/securing-the-success-sisco.html Wed, 30 Dec 2015 11:08:11 +0530 Rank 10Segment: BioSupplier-DistributorOrganization: Sisco Research Laboratories MD: Mr S K Agarwal Revenue: Rs 24.01 crore   Mumbai-based Sisco Research Laboratories' (SRL) total revenue for the FY 2014-15 was Rs 24.01 crore. This was an almost seven percent increase from Rs 22.50 crore in FY2013-14. Sisco is one of the first Indian companies since 1975, specialized in manufacturing biochemicals, bioreagents and organic intermediates under the SRL brand. The company now manufactures and markets more than 5000 products including electrophoresis reagents, enzymes and substrates, critical R&D surfactants and detergents, biochemicals, HPLC and GC-HS solvents and reagents, PCR & DNA products, dehydrated culture media for biopharma production, molecular biology reagents, nanopowders and carbon nanotubes and other general laboratory chemicals. SRL is one of the first companies to launch nanotech products in India in 2009. Its products have spearheaded the emergence of nanosciences in the areas of agriculture, health, environment and materials sciences. In the previous fiscal SRL established itself as one of the most reliable suppliers for dehydrated media in bulk and for lifescience research. The BioLit DNA and Protein Tools line of the company, encompassing of reagents for DNA, RNA and protein research, also saw excellent acceptance and sales performance by the biotech industry. The company introduces many specialized chemical intermediates and organic compounds in FY2014-15 which saw good movement in MNC pharmaceutical companies. The firms' nanotech product line saw almost 100 research papers published with SRL products in their citations, establishing furthermore, the significance of its product line in the global Nanoscience space. In 2014-15, SRL plants were GMP certified by Food and Drug Authority, Govt. of Maharashtra enabling better customer-specific regulatory requirements. In addition, Mr SK Agarwal was awarded the Indian Achiever's Award for industry development in the field of Corporate Social Responsibility (CSR) and Sustainable Development, Feb 2014, for his outstanding and long contribution to the industry. The other key strategy initiatives by the company in the past fiscal included strategic expansion of its BioLit DNA and Protein Tools to include TAQ Polymerases, protein ladders and DNA ladders, new marketing initiatives to attract customers in the government and industrial sectors for bulk and research quantities; Road shows across India and Asia; and participation in global laboratory expo's and conferences. The firms' new range of graphene and aminated nanopowders, biological ingredients for microbiology research, chemical intermediates and rare fine chemicals for quality control, price-revisions to attract purchasers, brand awareness and promotion measures has led to its consistent growth during the FY 2014-15. ]]> https://biospectrumindia.com/reports-white-papers/97/3516/rd-steps-for-new-membranes.html https://biospectrumindia.com/reports-white-papers/97/3516/rd-steps-for-new-membranes.html Wed, 30 Dec 2015 11:02:30 +0530 Rank: 9Segment: BioSupplier-DistributorOrganization: Permionics Membranes MD: Mr Satyajai Mayor Bioscience Revenue: Rs 25 crore   Permionics is the first and only company in India to indigenously manufacture Reverse-Osmosis (RO), Ultra-Filtration (UF), and Nano-Filtration (NF) membranes for various process specific applications. It custom-designs and engineers complete membrane-based systems from pilot to commercial scale to suit the specific requirements of petrochemical, biotech, biochemical, pharmaceutical, food & beverage, dairy, chemical and other sectors. Permionics is also a pioneer in manufacturing of Reverse-Osmosis, Ultra-Filtration, Nano-Filtration Membranes and Technology for the application of Water Treatment, Effluent Recycling, Sewage Recycling and Special Process Applications. Today, Permionics has the most extensive range of membranes to suit any process parameters with having more than 2500 installations since last 30 years in India, the UK, Syria, Jordan, Ethiopia, Kuwait, Vietnam, Pakistan and Dubai. Permionics is exploring R&D initiatives for developing new membranes as well as applications for solvent recovery, chemical and biochemical processes, and water and waste segments. Its key strategies includes integration of membrane technology in the upstream of the processes to foster product recovery and reuse, which finally reduces the load on the downstream effluent. Permionics had, since early 1980s, installed membrane systems for product recovery from MLs and purification of solvents. This made it possible to constantly develop and install applications for the biotech and pharmaceutical sectors as well as the main stream biotech applications such as fermentation broth clarification, concentration. The wide range of membranes with the various cut offs is unique and helps the company to handle wide types of applications for MF, UF, NF and RO processes. The company witnessed the development of new membranes during the year. It also expanded product recovery areas, both for biotech, and pharma. Better facilities for characterization of existing as well as upcoming membranes were developed during the year. Permionics was conceived and pioneered by Mr S P Mayor, a hydraulic engineer from Imperial College, London, with a bachelor's degree from Oxford University. A 5 years' experience in building hydroelectric power stations for The English Electric Company led Mr Mayor towards developing a passionate interest in water - its availability and conservation - and thereby a concern about the rapid desecration and depletion of waterresources. The progressive demonstration of cellulose acetate membranes for desalination of sea water by Dr S Sourirajan (University of Ottawa) synergized with Mr Mayor's ideology and evolved a quest in him to develop the Cellulose Acetate Reverse Osmosis membrane indigenously. ]]> https://biospectrumindia.com/reports-white-papers/97/3515/escalating-the-growth.html https://biospectrumindia.com/reports-white-papers/97/3515/escalating-the-growth.html Wed, 30 Dec 2015 10:53:45 +0530 Rank: 8Segment: BioSupplier-DistributorOrganization: Esco Biotech President: Mr Sameer Maheshwari Revenue: Rs 25.69 crore   Esco Biotech Pvt Ltd is a leading supplier of high quality laboratory equipment to Biotech and Pharmaceutical sector with emphasis on after sales service support. The firm with focused dedication, thousands of installations and trusted relationships with leading life sciences and healthcare Companies, research organizations and educational institutes has emerged as a preferred supplier of world class laboratory instruments and clean room equipment. For the FY2014-15, Esco's revenue stood at Rs 25.69 crore as opposed to Rs 22.24 crore in the FY13-14. The company attributes its growth to the new biosciences hubs coming up which function as a significant research and production center and also growth in exports of generic drugs. Esco's product range includes Laminar air flow cabinets, biological safety cabinets, CO2 incubators, deep freezers, laboratory fume hoods, hospital pharmacy Isolators, cytotoxic cabinets, shakers, centrifuges, PCR thermal cycler, shaking micro incubators, multi room CO2 incubator, multizone ART workstation, modular clean room construction components etc. The company has the largest installed base of imported biological safety cabinets in India with over 4,000 cabinets installed all over the country in different pharma companies, biotech companies, research institutes, universities and educational institutes. Last fiscal, the company added many products to its portfolio. It launched laboratory shakers, laboratory centrifuges, constant climate chambers, ventilated balance enclosures, Containment Barrier Isolators (CBI), Aseptic Containment Isolators (ACTI), Weighing and Dispensing Containment Isolators (WDCI), General Processing Platform Isolators (GPPI), Dynamic Pass boxes and Dynamic Floor Label Hatches, BelloSafe-Iso System with Integrated Shaker, CO2 incubator and isolator.The other performance highlights of the company in the last fiscal include establishment of Esco pharma, medical, animal science and fume hood division. Esco Biotech distributes its products in more than 100 countries and has a direct presence in 10 of the key global markets. With the most extensive product line in the industry, Esco claims it has passed more tests, in more languages, for more certifications, throughout more countries than any biological safety cabinet manufacturer worldwide. Esco remains dedicated to delivering innovative solutions for the clinical, life science, research and industrial laboratory community. Esco directs a highly efficient research, product development, manufacturing and customer service program. In addition, Esco aims to establish and strengthen its Corporate Social Responsibility (CSR) as part of its commitment to serve its customers and the community, as well as to preserve the environment. ]]> https://biospectrumindia.com/reports-white-papers/97/3442/successful-saksham.html https://biospectrumindia.com/reports-white-papers/97/3442/successful-saksham.html Wed, 30 Dec 2015 10:37:13 +0530 Rank: 7Segment: BioSupplier-DistributorOrganization: Saksham Technologies Chief - Customer Support: Mr Sameer MaheshwariBioscience Revenue: Rs 30.04 crore   Saksham Technologies' total revenue for the fiscal 2014-15 was Rs 30.04 crore. This is an increase of over 13 percent from Rs 26 crore in the fiscal 2013-14. This year the firm is targeting a growth of 30 percent. As per the company, new biosciences hub coming up will function as significant research and production center. The growth in exports of generic drugs have also helped Saksham in its progress. With over two decades of focused dedication, thousands of installations and trusted relationships with leading life sciences and healthcare companies, research organizations and educational institutes, Saksham Technologies has grown up to become a preferred supplier of world class laboratory equipment for various scientific applications. Since its inception in 1992, the firm has been workingclosely with its customers to understand their needs and requirements to suggest appropriate solutions for respective applications. The company's reputation for problem solving has been earned through timely support on service and application engineering with in-house capabilities for critical jobs of refrigeration, clean air, high pressureand vacuum engineering. It has also developed an expertise on validation services for various equipment with comprehensive documentation capabilities. With headquarters in Mumbai, Saksham Technologies has branched out to all parts of the country with regional offices in Bangalore and Delhi. The company has had a busy year and partnered with many national and international organizations. Saksham signed Memorandum of Understanding (MoU) with Airinspace, France, to promote their Air Decontamination Units; with Cesco Bioengineering, Taiwan, to promote their Bioreactors; with GT Scien, Korea, to promote their Clean Air Systems; with Labor Security System, Italy, to promote their Solvent Storage Cabinets; with PlasLabs, USA to promote their Glove Boxes and Isolators; with Pre-Sens, Germany, to promote their Sensor Probes, Transmitters and Complete Systems. In addition, the company also signed MoU with Planer, the UK, to promote their Cryogenic Freezers; with RI Lifesciences to promote their Micromanipulators; UVITec, the UK, to promote their Fluorescent Gel and Chemiluminescence Systems; with Edstrom, USA, to promote their Animal Watering Systems and Bottle Filling Stations for Animals and with ClorDiSys, USA to promote their Chlorine Dioxide Gas Generators. As per Saksham, the company shall continue to strive for excellence in customer satisfaction and contribute significantly towards the success of plans and activities of their customers. ]]> https://biospectrumindia.com/reports-white-papers/97/3438/focus-on-value-added-services.html https://biospectrumindia.com/reports-white-papers/97/3438/focus-on-value-added-services.html Wed, 30 Dec 2015 10:31:27 +0530 Rank: 6Segment: BioSupplier-DistributorOrganization: BI Biotech India MD: Vinaya K Dubey Revenue: Rs 34.32 crore   Established in 1984, New Delhi-based BI Biotech India is a major distributor in biological research reagents, analytical equipments, plasticware and glassware. It is primarily involved in distribution of biological research reagents and equipment from major manufacturing companies from USA, Europe and China. The organization has continually endeavored to achieve its objectives to provide high-quality and innovative products to scientists and researchers at competitive price in a timely fashion. The organization has gained recognition by entrusting three fundamentals: Value, Service and Support. It is keen to make research easier for its customers by searching worldwide, and offering one of the world's most comprehensive lines of laboratory tools for life sciences. Bibiotech stands has positioned itself as a preferred supplier in the life sciences market segment. It has earned credibility and established itself into the life science research market, with a key focus on providing customers with value added services.Its key business strategies encompasses utilizing market orientation strategies, organizing more number of road shows, and reaching out to customers through e-mailers. Mr Vinaya attributes the company's growth to its relentless customer services offered to its clients. However, Government's instability and the fluctuations in Dollar and Indian prices led to a few setbacks for the company. Bibiotech introduced its cost effective do-it-yourself ELISA Kit. It also introduced molecular range of products in its portfolio. It has also started offering freight free shipments for products. In the next couple of years, it focuses on extending its sales network, enhancing services, and establishing itself as an important source, for not only its key products, but also for newly developed product alternatives. Its partners include renowned names in the industry including Bellco, Bachem, Cedarlane, Tiangen Biotech, Santa Cruz Biotechnology, R&D Systems, Novus, Tocris, BostonBiochem, and AnaSpec. ]]> https://biospectrumindia.com/reports-white-papers/97/3428/the-growth-story-continues.html https://biospectrumindia.com/reports-white-papers/97/3428/the-growth-story-continues.html Wed, 30 Dec 2015 10:19:03 +0530 Rank: 4Segment: BioSupplier-DistributorOrganization: Towa Optics India MD: Mr Rakesh Batra Bioscience Revenue: Rs 92.86 crore   In FY2014-15, New Delhi-based Towa Optics did Rs 92.86 crore of business as opposed to Rs 83.85 crore in the FY2013-14. The firm registered a growth of around 10 percent from the previous fiscal. Towa Optics (India) Pvt Ltd is the authorized distributor of many leading international companies such as Nikon Corporation, Japan; Andor, the UK; Bitplane, Switzerland; Linkam, the UK; and Laboratory Imaging, Czech for their products like Nikon biological & industrial microscopes, Andor EMCCD & SCMOS cameras, Spinning Disc Confocal, Imaris Imaging Software, Linkam Heating & Freezing stages, and Lucia Karyotyping/Fish/Cytogenetics system. Towa has graphed a dramatic growth in sales in the past few years. The firm aspires not only to meet needs of the customer but also provide customers with new value that exceeds their expectations. In one of the major deals in the last fiscal, Towa has set up an imaging facility at NCBS, Bangalore, for Nikon super resolution microscope. Mr Rakesh Batra, managing director, joined the company in 1975.Under his dynamic leadership Towa diversified and entered into trading activities. Towa became exclusive distributors of Nikon Corporation, Japan, for the latters biological microscopes in India. Initially it was not easy to sell Nikon microscopes, as it was known only for cameras. In a short time due to his aggressive promotion and defined sales strategy, Nikon microscopes became popular and currently occupy more than 28 percent market share. Looking at the positive response from the market Towa expanded their activities and ventured into biomedical and biotechnology research market. The firm says its plans for FY 2015-16 will be to continue with quality equipment and dedicated customer service that enables them to propel and be ready for the next phase of growth. On the revenue side, Towa is targeting a growth of 10 percent in the current financial year too. Towa aims to provide high-quality instruments and equipment and dedicated services to its customers. By adding a consistent, comprehensive, value-oriented philosophy, the company is working to establish a business model within each stage of the process to enhance profitability as well as to make Towa more resilient to today's harsh and fast changing business environment. These efforts will make it more market responsive as a company. It will be its endeavour to become a 'total solutions provider' to the scientific community. Keeping pace with the scientific development in India and worldwide, Towa focuses on being a customer oriented company by adhering to its principles of sincerity, customer services, business ethics and integrity ]]> https://biospectrumindia.com/reports-white-papers/97/8043/pushing-the-boundaries.html https://biospectrumindia.com/reports-white-papers/97/8043/pushing-the-boundaries.html Wed, 30 Dec 2015 10:11:00 +0530 Rank: 3Segment: BioSupplier-DistributorOrganization: Premas Lifescience Executive Director: Mr Praveen Gupta Revenue: Rs 104 crore   In the FY2014-15, Premas Lifescience registered a good year on year (YOY) growth of 61 percent, and sold almost Rs 104 crore worth of products and services as against Rs 66 crore in the FY13-14. Premas is the supplier of Illumina range of products. Recently, it was also appointed India's sole distributor for Hamilton Robotics. Another highlight for the company in the past fiscal was that it has received the best distributor award from Illumina for two years in a row. While the firm's Illumina business continues to draw the highest share of the revenue, it also recorded a significant increase in its non Illumina business last year. As per the company, the key drivers of growth were higher pull through sale of reagents from its existing customers and adoption of the next generation sequencing (NGS) technology by applied markets, mainly clinical.Increased number of service providers adopting its technologies contributed significant growth to its business.The firm sold more than 25 new platforms in the last year and it is hoping to see even higher reagent pull this year. Premas was also successful in bagging some large contracts of multi-sample genome re-sequencing projects from leading research institutes. The other striking feature of its success last year was that 50 percent of its business came from private accounts.   The firm's diverse product portfolio encompassing an array of high-end genomics equipment and associated services has generated waves in the genetic diagnosis and research markets. Apart from lifesciences, Premas' venture into agro, food testing and forensic testing sectors. Both the verticals at Premas Biotech i.e. the Premas life sciences business and the contract manufacturing and research services areshowing significant growth and it is planning to continue and expand to other markets with newer products and services. Premas has an advanced manufacturing facility (1500 litre fermentation) at Manesar wherein it manufactures a lot of recombinant proteins for many global life science, diagnostic, pharma and agriculture bio players. The firm has cloned and expressed more than 500 proteins and developed CHO cell lines and expression vectors in last seven years. Based on this, it has successfully completed many custom projects for large global players. Premas, upon requests from its partners, is also exploring option of extending its brand out of India and replicating the same business model in other regions. It plans to develop and manufacture Dx panels in India which can be for domestic consumption as well as for exports. The firm wishes to move up the value chain and offer analysis and analytics solutions to the global life sciences and MDx market. ]]> https://biospectrumindia.com/reports-white-papers/97/7622/registers-mild-growth.html https://biospectrumindia.com/reports-white-papers/97/7622/registers-mild-growth.html Wed, 30 Dec 2015 10:05:59 +0530 Rank: 2Segment: BioSupplier-DistributorOrganization: Imperial Life Sciences Director - Sales & Marketing: Mr Neeraj GuptaRevenue: Rs 219 crore    Imperial Life Sciences (ILS) has succeeded in retaining its business growth despite the adverse conditions in the market segments of its operation. As against Rs 212 crore registered during the FY2013-14, Imperial recorded Rs 219 crore in the current fiscal year. The distributor company, known as complete solution provider in the instrumentation, reagents, and molecular diagnostics, has been utilizing every strategy to make its mark felt. It is known for its in-house services on Affymetrix and Agena Platforms along with bioinformatics. Besides this, it has the entire range of products for genomics, proteomics, cell culture, drug discovery and bio-production labs. The basic plan in Imperial's current marketing strategy is to overcome the challenges of funding crunch in India. Company has managed to balance the sale by collaborating with some of the leading private companies in India especially on providing the services on Pacific Biosciences platforms. ILS executed a project in agri-genomics sector for total 10,000 samples which was a milestone to achieve.Among the major announcements during 2014-15, the company has also started its in-house projects as a service provider especially on Microarrays and Mass Array technologies at cost-effective pricing. The company also stepped into molecular diagnostic market and is growing the business in this segment at a good pace. It offers cutting edge solutions in molecular diagnostics backed by highly accurate and sensitive technologies for the non-invasive prenatal testing, prenatal and postnatal whole genome chromosomal microarray analysis, multiplexed genetic screening tests for lung and colon cancer, genotyping based genetic tests for beta thalassemia, cystic fibrosis and blood group typing and custom project based service. During the year, ILS also launched products and services including Massarray from Agena, and nCounter analysis system from NanoString. Among the major deals, Imperial started a separate division for advanced molecular diagostics, service lab for Microarray and Massarray technology users apart from partnering with Agena Biosciences and NanoStrring technologies, leaders in Massarray and ncounter analysis technologies respectively. As per the company's spokesperson, the biggest hindrance for the overall growth of the business was decreased funding from government bodies but Imperial took a proactive approach in order to meet the gap by majorly focusing on partnering with other private players in the markets. For future, company intends to get listed among topmost companies in the supplier industry for customer delight and all major business segments. ]]> https://biospectrumindia.com/reports-white-papers/97/3423/dss-holds-its-ground.html https://biospectrumindia.com/reports-white-papers/97/3423/dss-holds-its-ground.html Wed, 30 Dec 2015 10:00:32 +0530 Rank: 1Segment: BioSupplier-DistributorOrganization: DSS Imagetech CEO: Mr Arvinder Singh Dhingra Bioscience Revenue: Rs 221 crore    DSS Imagetech is no longer known only for microscopy but the company has now gradually expanded its product range besides venturing into manufacturing of high-end molecular biology reagents. The company registered an impressive 12 percent growth with revenues jumping to Rs 221 crore in FY 2014-15 as compared to Rs 198 crore in the FY 2013-14. DSS enjoys a unique position as the most informed supplier of microscopes and digital imaging solutions in the country. On May 13, 2011, DSS entered into collaboration with Sakura Finetek for its Micro-Imaging Division. Sakura is the original manufacturer of the tissue processors, embedder, rotary microtome, and centrifuge that have become industry standards over the years in histopathology market. It has set up long standing collaborations with world leaders in the scientific field like Olympus, Abbott Molecular, Dako - Agilent among others. Not only has DSS been able to establish relationships with world renowned international corporations, but it has also been able to sustain these relationships over time. Among key strategies, the company has put in place an organizational restructuring to capitalize on the synergy between foreign-make microscopes (Olympus Microscopes Japan) and locally manufactured microscopes (Olympus Opto Systems India). Among the major collaborations in 2014-15 is the company's tie up with Abberior Instruments (founded by Nobel Laureate - Dr Stefan Hell) for STED Super Resolution Microscopy. Also, the Magnus MLX Plus (Theia) Series Microscope was launched by Olympus Opto Systems India besides Olympus Endo-Sono (EU-ME2) launched by Olympus (Endoscopes) Japan. DSS Imagetech has also formed a joint venture namely DSS Takara Bio India along with the Japanese company, Takara Bio Inc. The new spin off company is looking at strengthening its manufacturing capability to offer competitive research reagent and kits suited for the local market needs. DSS Takara Bio's major thrust has been to establish the manufacturing facility of molecular biology reagents. The company launched the product line in August, 2012 and plans to offer the diagnostic kits at a never seen before lowest price in India. DSS also started the TAQ DNA Polymerase production at DSS Takara Bio India manufacturing site. The company now manufactures and exports products to Japan; and thereafter they are distributed across the world. Going a step further, DSS R&D Center was formed in 2013 to contribute more to the field of biotechnology. DSS R&D center has signed a deal with Department of Biotechnology for a joint project to develop a cost-effective sexually transmitted disease (CT/NG) detection kit. Apart from this DSS R&D center is working on various projects to develop in house products under the DSS brand name. ]]> https://biospectrumindia.com/reports-white-papers/97/7967/set-to-expand-foothold-in-india.html https://biospectrumindia.com/reports-white-papers/97/7967/set-to-expand-foothold-in-india.html Tue, 29 Dec 2015 11:40:43 +0530 Rank: 7Organization: Cole Parmer India Pvt Ltd MD-APAC: Mr Rakesh Aggarwal Revenue: Rs 62 crore   Cole-Parmer, with over 60 years of experience and an extensive portfolio of fluid handling and analysis products that meets numerous applications and customized needs of its customers, is aggressively concentrating on expanding its presence in India and bringing new products and solutions to the customers while partnering in its innovations. The company has been meticulously focusing on India and Asia Pacific and enhancing its product portfolio. It recorded Rs 62 crore in revenue during the year 2014-15 compared to Rs 47 crore grossed in the last fiscal year. Cole-Parmer has been in India for more than 15 years, with a direct presence in the last nine years and has established a strong presence in the pharma and biopharma markets. For biopharma product development, Cole-Parmer is proficient in providing custom solutions and scale-up assistance from research and development to pilot and finally to manufacturing. With multitude of unique products encompassing fluid handling, electrochemistry, life science, laboratory products and consumables complimented well with exceptional service, makes Cole-Parmer a preferred partner in delivering solutions to the scientific and engineering community. Cole-Parmer recently acquired Swiss-engineered Ismatec pumps, renowned for its clock-like precision and manufactured according to strict ISO 9001:2008 standards. This has further expanded Cole-Parmer's robust line of fluid handling and analysis products. Prior to that, the company also acquired Environmental Express, a leading developer, manufacturer, and distributor of environmental laboratory equipment and consumables. These acquisitions are a key step toward further strengthening the company's portfolio and expanding its horizons with a strong worldwide presence. Carrying on the strong foundation, the company aims at continuous growth in its current business segment and therefore is regularly investing in expanding its foothold in India. Among the recent initiatives, the company opened a new corporate office in Mumbai and direct offices in major metro cities. It also has set up a new warehouse in Bhiwandi with state-of-the-art infrastructure and is also expanding its resources, with an aim to provide faster responses and overall enhanced customer experience. Apart from the range from Ismatec and Environmental Express, amongst the new entrants are Digi-Sense's test and measurement products, new portable meter series from Oakton, a new line of laboratory filtration range and safety consumables to name a few. In the bioprocess manufacturing space, Cole-Parmer is the most trusted choice for their Masterflex Peristaltic Pumps and fully validated pharma tubing. Other key application areas, in which end-to-end customized solutions are most looked for are aseptic fluid transfer, including a wide range of single-use products such as bioprocess bags and liners, manifolds, and EZ Top container closures. ]]> https://biospectrumindia.com/reports-white-papers/97/7957/plunging-growth.html https://biospectrumindia.com/reports-white-papers/97/7957/plunging-growth.html Tue, 29 Dec 2015 11:35:33 +0530 Rank: 6Organization: Eppendorf India Ltd CEO: Mr V Sankaranarayanan Bioscience Revenue: Rs 109.75 crore   Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for liquid handling, sample handling, and cell handling in laboratories worldwide. Its product range includes pipettes and automated pipetting systems, dispensers, centrifuges, mixers, spectrometers, and DNA amplification equipment as well as ultra-low temperature freezers, fermenters, bioreactors, CO2 incubators, shakers, and cell manipulation systems. Consumables such as pipette tips, test tubes, microliter plates, and disposable bioreactors complement the range of highest-quality premium products. The firms' products are most broadly used in academic and commercial research laboratories, e.g., in companies from the pharmaceutical and biotechnological as well as the chemical and food industries. They are also aimed at clinical and environmental analysis laboratories, forensics, and at industrial laboratories performing process analysis, production, and quality assurance. Eppendorf was founded in Hamburg, Germany in 1945 and has about 2,850 employees worldwide. The company has subsidiaries in 25 countries and is represented in all other markets by distributors. Eppendorf India, the Indian arm of Eppendorf AG was established in 2003 to cater and be closer to the customers of the sub-continent and continue being an expert partner in life sciences laboratories. The company is headquartered in Chennai. In the last fiscal, the company launched Conical Tube 15 mL and 50 mL. The new Eppendorf Conical Tubes 15 mL and 50 mL broaden the volume range of Eppendorf Tubes. With the introduction of the two screw cap tubes, Eppendorf Tubes now cover the entire volume range from 0.5 mL to 50 mL. In addition, Eppendorf India has received expanded NABL Accreditation for calibration services for volume, temperature, speed and time. The company can now can perform NABL calibration onsite for various laboratory instruments such as centrifuges, incubators (CO2 and BOD), incubator shakers, freezers (Cryo, ULT, -45 °C, -20 °C), Thermomixer or dry bath, water bath, autoclave, etc. Eppendorf launched official Eppendorf App with a broad range of functionalities, including an Eppendorf product catalog, a news section and a BioNews archive. Moreover the app provides a number of helpful lab tools such as lab timers or calculators and conversion tools for typical routine applications in the laboratory. For customers who want to purchase products, the app offers a direct link to our Eppendorf eShops without leaving the app. The app is available free of charge in the Apple's App Store for the iPad and iPhone and also for the users of Android ]]> https://biospectrumindia.com/reports-white-papers/97/3017/products-promote-efficiency.html https://biospectrumindia.com/reports-white-papers/97/3017/products-promote-efficiency.html Tue, 29 Dec 2015 11:28:16 +0530 Rank: 5Organization: West Pharmaceutical ServicesCountry manager & Director India: Mr Alagu SubramaniamBioscience Revenue: Rs 200 crore   West Pharmaceutical Services is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. The company is headquartered in Exton, Pennsylvania, USA, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2014 sales of $1.42 billion reflect the daily use of approximately 110 million of its components and devices,which are designed to improve the delivery of healthcare to patients around the world. In 2014-15, the company recorded estimated revenue of Rs 200 crore compared to Rs 186 crore last year. Working by the side of its customers from concept to patient, West creates products that promote efficiency, reliability and safety of the world's pharmaceutical drug supply. In July 2014,West dedicated its manufacturing plant in the Sri City Special Economic Zone (SEZ) in Southern India, where the company intends to expand its growing primary packaging for injectable medicines business. In October 2014, it announced plans for a new facility in Waterford, Ireland, designed to meet growing demand for its proprietary insulin packaging systems and advanced finishing operations for high-value closure systems.Recently, the groundbreaking event took place at Waterford. Additionally, capacity was also added to its Kinston, North Carolina (USA) and Scottsdale, Arizona (USA) facilities in 2014. West supports customers with advanced production technologies, expertise in global regulatory compliance and an ever-growing knowledge base of drug product testing, development and delivery. It also supports patients with high-quality products that are intended to address the challenges they face today-at-home administration of medicine, safety, dosing accuracy and the importance of being adherent with medicines. The company, however, remains tight-lipped about divulging its future plans publicly. In February 2015, West announced the availability of a new sterile drug vial seal, the Flip-Off PlusRU seal. Part of West's Flip-Off seal product family, these new and ready-to-use seals help pharmaceutical and biopharmaceutical manufacturers protect the safety and integrity of their drug products while meeting regulatory requirements for increased drug cleanliness and safety. Dr Donald E Morel Jr, chairman of the board and CEO, announced his intention to retire after leading the company for 12 years. His successor, Mr Eric Green began as the new CEO on April 15, 2015. The company expects sales in 2015 will be led by high value products designed for biologic drugs, rising sales of proprietary drug delivery devices, and requirements for on-going programs using Daikyo Crystal Zenith containers and the SmartDose electronic wearable injector. Vaccines and therapeutics are important segments for West, and contract research for its future growth. ]]> https://biospectrumindia.com/news/97/7978/samsung-strengthens-wearable-device-portfolio-.html https://biospectrumindia.com/news/97/7978/samsung-strengthens-wearable-device-portfolio-.html Tue, 29 Dec 2015 11:28:00 +0530 Samsung Electronics is set to launch all-in-one advanced system logic chip, Bio-Processor, for the health-oriented wearables market. The Samsung Bio-Processor is designed to allow accelerated development of innovative wearable products for consumers who are increasingly monitoring their health and fitness on a daily basis. "With improvements in smart, fitness devices and an increase in consumer health consciousness, more and more people are looking for ways to monitor various personal bio-data, or fitness data, to constantly manage their health" said Mr Ben K Hur, vice president, marketing, System LSI business at Samsung Electronics. "Samsung's Bio-Processor, which can process five different biometric signals, is the most versatile health and fitness monitoring chip available on the market today and is expected to open up many new health-based service options for our customers." While heart rate monitoring alone may have been compelling in the past, the ability to measure a variety of fitness data is expected in today's wearable products. To meet such demands, Samsung has designed its Bio-Processor to integrate five AFEs including bioelectrical impedance analysis (BIA), photoplethysmogram (PPG), electrocardiogram (ECG), skin temperature, and galvanic skin response (GSR) into a single chip solution that measures body fat, and skeletal muscle mass, heart rate, heart rhythm, skin temperature and stress level, respectively.  ]]> https://biospectrumindia.com/reports-white-papers/97/7962/shimadzu-maintains-its-rd-edge.html https://biospectrumindia.com/reports-white-papers/97/7962/shimadzu-maintains-its-rd-edge.html Tue, 29 Dec 2015 11:23:22 +0530 Rank: 4Organization: Shimadzu Analytical (India) Pvt LtdMD: Mr Yoshiyuki Fujino Bioscience Revenue: Rs 251.7 crore   Based on the corporate philosophy "Contributing to Society through Science and Technology" that represents the pioneering spirit inherited from its founder, Shimadzu Corporation has continued to progress hand-in-hand with science, building itself into a leader in technology, since its foundation in Kyoto, Japan in 1875. Perhaps only analytical company with a glorious past of over 100 years, Shimadzu is celebrating its 140th anniversary. In India, Shimadzu registered the revenue of Rs 251.7 crore during FY2014-15 as compared to Rs 229.2 crore in FY2013-14. The performance of the company has been going stronger slowly but steadily. From Analytical balances to the most high-end Mass Spectrometers, Shimadzu has been developing a wide range of analytical and life science instrumentation that consistently meet the needs of scientists helping them to face their analytical challenges with confidence. The performance during the last one year has been noteworthy. Shimdzu got great success in Indian Clinical CRO market with its LCMSMS systems. It registered major wins for newly launched GCMS - TQ systems in food and pharma markets. Besides that it has strengthened presence in diagnostics market with new born screening solutions using LCMSMS and GCMS platforms. It has expanded into the food safety market with total testing solutions, right from basic instrumentation to high end solutions using LCMSMS and GCMS with continuously advancing technologies. It has also enhanced the position in regulatory pharma segment with lab solutions software for enhanced regulatory compliance. More importantly, company has gained market share in emerging UHPLC solutions as well. During the year, Shimadzu has launched LCMS-8060, the latest in Ultra-Fast Mass Spectrometry line, that has been designed to deliver the highest sensitivity and fast analysis speed as compared to any other LCMS in the market today. With the launch of Shimadzu LCMS-8060, it has been able to offer widest range of applications to the industry and academia. As a result of a series of fast developing and innovative technologies, Shimadzu has introduced four models of mass spectrometers within a span of five years. Principally what has been driving Shimadzu is the capability to identify new applications and develop simpler solutions catering to these applications. In the recent past, food analysis was a novel challenge but it has nailed it and now its current focus is on offering suave solutions for the biopharmaceutical industry. In the recent few years, there has been tremendous increase in commercialization of antibody drug conjugates, and this segment constitutes major portion of blockbuster drugs. Big business potential is foreseen for this sector for the next few years to come and Shimadzu is all set to offer solutions to face the complex challenges of characterization and quantitation. ]]> https://biospectrumindia.com/news/97/7974/waters-products-named-top-innovations-for-2015-.html https://biospectrumindia.com/news/97/7974/waters-products-named-top-innovations-for-2015-.html Tue, 29 Dec 2015 11:17:56 +0530 Waters Corporation has announced that its Full Spectrum Molecular Imaging System and its REIMS Research System with iKnife Sampling placed first and second among top innovations of 2015 as judged by The Analytical Scientist magazine. "On behalf of all Waters employees, I want to thank The Analytical Scientist magazine for these awards," said Mr Art Caputo, president, Waters Division. "As proud as we are of this recognition, our focus continues to be on helping scientists reach their research goals, whether it's ensuring the safety of our food supplies or bringing life-saving medicines to patients." An independent panel of judges awarded top honors to the two new mass spectrometry-based systems, both of which were introduced in 2015. The Waters Full Spectrum Molecular Imaging System is said to be the first such system to combine three technologies: matrix assisted laser desorption ionization (MALDI) imaging, desorption electrospray ionization (DESI) imaging and ion mobility, the Full Spectrum Molecular Imaging System delivers multi-layered, information-rich data from a single sample. Rapid Evaporative Ionization Mass Spectrometry (REIMS) Research System with iKnife Sampling combines direct-from-sample ionization with high performance time-of-flight mass spectrometry and powerful, intuitive analytics, the Rapid Evaporative Ionization Mass Spectrometry (REIMS) Research System with iKnife Sampling provides food, microbiology and tissue researchers with near-instantaneous data acquisition.   Removing the need for sample preparation and chromatographic separation, the system has the potential to make a huge impact on the time and money required to analyze large numbers of samples by mass spectrometry. When combined with multivariate statistical analysis, research scientists can quickly and easily differentiate samples from one another and confidently identify the differentiating features, allowing greater insight into chemical and biological systems.     ]]> https://biospectrumindia.com/reports-white-papers/97/7958/agilent-remains-focused.html https://biospectrumindia.com/reports-white-papers/97/7958/agilent-remains-focused.html Tue, 29 Dec 2015 11:17:27 +0530 Rank: 3Organization: Agilent Technologies President and Country GM: Mr Parmeet S AhujaBioscience revenue: Rs 463 crore   In FY 2014-15, Agilent India's life sciences business is estimated at Rs 463 crore with a growth of over 10 percent as compared to FY2013-14 when it recorded Rs 423 crore (15 percent growth). Slowdown can be been broadly attributed to the overall market scenario and lack of funds in government and research institutes. Despite the prevailing conditions due to which customers across markets have been very cautious in purchase, Agilent has been able to retain its growth to some extent. One of the biggest contributor to the Agilent's Life Sciences and Chemical Analysis (LSCA) business in India has been the pharma sector. It has been also growing significantly in food testing where it has done exceedingly well in last few years. The other areas that it has been focusing on are material and environmental sciences. In parallel, it has also been reaching out to colleges and universities and the focus is on the direct channels so that there is quality. The company delivers 100-150 platforms every year. Its percentage of contribution to new clients has been growing. About 60 percent of Agilent India's revenue comes from the LSCA group and 25 percent of the revenue comes from the life sciences group in India. Overall, Agilent India contributes to one percent of total revenue of Agilent. The company intends to expand big time into other areas of the Indian market, such as environmental and material science. The acquisition of Dako, one-of-the-leading global suppliers of cancer diagnostics tools, providing antibodies, reagents, scientific instruments and software to customers, has helped the Agilent accelerate growth in several rapidly expanding areas of diagnostics, as well as strengthen its existing offerings. The completion of acquisition of Varian by the company has broadened its applications and solutions offerings in life sciences. It also expanded Agilent's product portfolio into atomic and molecular spectroscopy; establishes a leading position in NMR, imaging and vacuum technologies; and strengthens its consumables portfolio. Agilent has introduced many new products including the next generation Agilent 7100 Capillary Electrophoresis (CE) system. This is claimed to provide at least 10 times more sensitivity than any other commercial CE instrument. Its industry-benchmarked 1200 series HPLC and 7890 GC have been its biggest revenue generators. Agilent's Rapid Resolution LC (RRLC), a fast LC, has been a big success in the pharma segment. In November, 2014, Agilent introduced the 1290 Infinity II LC System, its new flagship instrument in the powerful 1200 Infinity Series LC portfolio. The system enables operators, scientists and laboratory managers to reach new levels of laboratory efficiency with the instrument's exceptional analytical quality, ease of use and ability to seamlessly integrate into any laboratory. ]]> https://biospectrumindia.com/reports-white-papers/97/7961/a-year-of-unprecedented-growth.html https://biospectrumindia.com/reports-white-papers/97/7961/a-year-of-unprecedented-growth.html Tue, 29 Dec 2015 11:10:11 +0530 Rank: 2Organization: Waters India Pvt Ltd President: Mr KV Venugopalan Revenue: Rs 722.66 crore   Waters clocked a turnover of whooping Rs 722.66 crore in the financial year 2014-15, an increase of about 28 percent in its revenue from the previous fiscal's Rs 564.38 crore. The company says the LC instrumentation business contributed to the major chunk of its business in India, while mass spectrometry uptake also jumped in sales. On a global basis biopharma sector showed a strong growth across product-lines sold to biopharma market. In one of the major deals in the last fiscal, Waters Corporation and Tecan Group entered into an agreement to combine Tecan's Freedom EVO liquid handling platform with Waters ACQUITY TQD liquid chromatograph/ mass spectrometer (LC/MS/MS) to automate sample preparation. Waters will combine the technologies from both companies into a single, fully-supported analytical system solution that helps laboratories increase assay throughput and efficiency, improve profitability, and drive down overall assay costs. During the last fiscal year, the firm unveiled a wide range of innovative products catering to the major disciplines of lifesciences. The firm's latest offerings include Xevo G2-XS QTof and Xevo TQ-S micro Mass Spectrometers, taking Benchtop Quantitative and Qualitative MS Applications to New Levels. It also added the SYNAPT G2-Si to its mass spectrometer product line. In the chromatography segment, the firm introduced the ACQUITY QDa Detector, bringing push-button mass detection to chromatography. The other products launched included UPLC System for nano- to micro scale separations - the ACQUITY UPLC M-Class System, CORTECS 2.7 Micron Columns Featuring Solid-Core Particle Technology, New ACQUITY Arc System, designed as a bridge between HPLC and UPLC Methods- single LC platform leads the way to enhanced productivity by replicating, improving or adjusting established LC methods and eDATA 2.0 proficiency testing portal for environmental laboratories - streamlined reporting and empowering new tools to help quality assurance managers monitor and improve laboratory performance. Besides launching new products, the company also updated its existing product line, for example, it updated Alliance HPLC Designs without impacting established validated methods. On its future plans, the firm said thatWaters is the leader in the field of liquid chromatographyand mass spectrometry and its focus continues to be in analytical technologies along with associated informatics solutions and chemistry products. Among the markets, its focus is on life sciences, clinical, food and environmental.However, in India Waters' main focus continues to be in the life sciences market. The company's innovative and dynamic range of product pipeline also bagged many awards such as the prestigious Pittcon Editors' Gold Award for the new Waters ACQUITY UPC(2) System as the best new product at Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, amongst many others. ]]> https://biospectrumindia.com/reports-white-papers/97/8323/brand-thermo-fisher-scientific-glitters-bright.html https://biospectrumindia.com/reports-white-papers/97/8323/brand-thermo-fisher-scientific-glitters-bright.html Mon, 28 Dec 2015 17:45:00 +0530 Rank: 1Organization: Thermo Fisher Scientific India Pvt LtdMD, VP/GM: Amit Chopra Bioscience Revenue: Rs 875 crore Thermo Fisher Scientific in India has made deep inroads into the Indian bioscience sector's research and development area. Registering a massive growth, the company garnered Rs 875 crore as annual turnover in 2014-15 as compared to Rs 661 crore in 2013-14. Thermo Fisher Scientific offers an unmatched portfolio of solutions for the life science research and bioprocessing industry including advanced analytical instrumentation, software, life science reagents and media, lab equipment and consumables and service support. Through the company's premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - Thermo Fisher offers an unmatched combination of innovative technologies, purchasing convenience and comprehensive support The company's innovative analytical instruments, lab equipment and specialty diagnostics also provide an option in getting accurate results for customers in research, clinical and applied markets. The major USP of the company is the most comprehensive offering of products and services to allow customers in a range of industries to increase productivity and efficiency. The customized support for researchers such as customized genes, assays, cell lines, kits, user training and onsite support combined with innovative instrumentation have helped company grow its presence in India. For providing access to the centers-of-excellence, the company has spread application labs and demonstration centers all across the country. This includes analytical demonstration center in Mumbai, the training center at Nasik, the chromatography center-of-excellence for APAC in Ahmedabad, life science application development centers in Delhi and Bengaluru, and a forensics lab in Delhi. It also opened a customer experience center for cell biology and genomics in Bangalore. It is also planning to add another analytical center in Delhi soon.As per the company, it invests more than $700 million in R&D annually. The parent company has strengthened bioproduction offering by acquiring Advanced Scientifics (ASI), a global provider of single-use technologies for customized bioprocessing solutions, for $300 million in cash.   Thermo Fisher Scientific also launched industry's only end-to-end, next-generation sequencing (NGS) genotyping solution for expanded microbial analysis. The new Ion 16S Metagenomics Kit provides a streamlined method for identifying bacteria from mixed culture samples. During the month of October 2015, Thermo Fisher Scientific launched the Ion S5 systems to provide a single solution for the widest range of targeted sequencing applications. The two NGS systems are designed to deliver a comprehensive solution that simplifies targeted sequencing. ]]> https://biospectrumindia.com/news/97/4686/biomrieux-illumina-launch-biomrieux-episeq.html https://biospectrumindia.com/news/97/4686/biomrieux-illumina-launch-biomrieux-episeq.html Wed, 23 Dec 2015 12:29:36 +0530 bioMérieux and Illumina announce the launch of bioMérieux EpiSeq, an innovative next-generation sequencing (NGS) service dedicated to the epidemiological monitoring and control of healthcare-associated infections. The bioMérieux EpiSeq service is the first result of the collaboration agreement signed by bioMérieux and Illumina in November 2014 bringing together the companies' respective leadership positions in microbiology and NGS to jointly develop applications for microbiology sequencing. By giving hospitals an improved understanding of the genetic markers of virulence and resistance, the service can help them understand how bacteria are transmitted, while enabling better containment of an epidemic, limiting the spread of infectious agents and improving surveillance approaches. "We are proud to partner with bioMérieux to bring this first-of-its-kind offering to market. NGS can be used to better characterize and understand infection-causing bacteria on a whole genome basis. With the growth of antibiotic resistant strains, this unique offering couldn't be more timely or important to the future of public health," said Mr Jay Flatley, CEO of Illumina. Hospitals facing a suspected epidemic or health crisis will be able to send bacterial isolates to a service laboratory designated by bioMérieux and equipped with an Illumina MiSeq sequencer. The genomic data is stored in a secure cloud platform and analyzed using the database and software developed by bioMérieux. Results showing the genomic profile of the infectious agents and the genetic variations identified by sequencing will be sent by bioMérieux to healthcare professionals in a customized, easy-to-interpret report. The bioMérieux EpiSeq service will first be launched in Europe followed by North America and Asia. The menu will initially consist of Staphylococcus aureus and will subsequently be expanded to include the other bacterial species most commonly responsible for healthcare-associated infections.   "In line with our pioneering spirit, we are very pleased to be the first company to offer our customers an innovative sequencing solution in bacterial epidemiology. The bioMérieux EpiSeq service addresses major public health challenges, combatting infectious diseases and resistance to antibiotics," said Mr Jean-Luc Belingard, chairman of bioMérieux. "The launch of bioMérieux EpiSeq marks a new and productive step in our partnership with Illumina for the application of NGS to bacterial genomes. This new offer represents a valuable innovation and opens up new prospects that can bring this revolutionary technology to tomorrow's healthcare."     ]]> https://biospectrumindia.com/features/97/8296/indias-trillion-dollar-opportunities-in-ict-iot.html https://biospectrumindia.com/features/97/8296/indias-trillion-dollar-opportunities-in-ict-iot.html Mon, 21 Dec 2015 10:34:20 +0530 In recent years, Internet of Things (IoT) has emerged as a buzzword, with both service providers and businesses, exploring possibilities connected devices can bring to the services they render and the way they conduct their businesses. IoT solutions are impacting the healthcare in a significant manner. Today, enterprises are realizing that the adoption of IoT in their operations will not only lead to increased productivity and process efficiencies, but also a reduction of costs. As a society, we are becoming more connected and the pace at which new technology is impacting our everyday lives is increasing at lightning speeds. IoT, M2M, ICT Over the next decade, the IoT and M2M (machine-to-machine) are expected to bring billions of data-generating devices online, and connect a vast stream of data with people, processes and other devices. There are some niche applications such as sensors record, ambulatory medical record (AMR) modem, and asset tracking.   "In the pharma and healthcare industries," says Mr Sai Pratyush, Additional VP, Managed Services, Tata Teleservices, "we see the increasing use of IoT in the form of people connecting to various healthcare devices. Also the use of wireless technology will allow healthcare workers and patients to rapidly access information. M2M communication connected wirelessly via sensors that transfer data automatically will improve efficiencies." The healthcare industry has long been overburdened by slow #mce_temp_url#moving innovation due to the complexity of the medical ecosystem that's changing aggressively, and IoT and M2M solutions are playing a catalyst role in this change and revolutionizing the pharma sector. "It will also be helpful in providing better medication-management and will be the fastest growing segment in the whole IoT market," predicts Mr Pratyush. Technology is playing a significant role in improving the quality of healthcare, cost efficiency, precision performance, proactive and on-time care, real-time communication and most importantly, saving lives. Tata Teleservices is working with partners to develop scalable ICT (Information and Communication Technologies) and IoT solutions across the healthcare value chain which includes hospitals, vendor ecosystem, doctors and individuals. The following are few areas which will see innovation, and will benefit both the industry as well as patients: • Outpatient monitoring• Wearables • Remote monitoring or rural healthcare• mHealth • Location based services ICT Trends In Indian Healthcare ICT and IoT solutions are impacting the healthcare in a significant manner. There is the wearables space which is enabling and pushing ordinary people to maintain a healthy lifestyle, and then, there are those simple innovations which are enabling the healthcare industry to provide better quality of care to its patients. Outpatient monitoring and telemedicine applications are introducing the healthcare industry to newer ways of interaction with patients and enabling them to not only monitor patients on a continuous basis but also respond more quickly to situations that need their attention. "As an example, a monitoring device is given to the patient at the time of discharge for a limited time frame, which helps the doctor to continue to monitor the patient and suggest corrective actions during the patient's recovery," states Mr Pratyush. As per a Deloitte Report, telemedicine is witnessing fast adoption in India. In 2012, the telemedicine market in India was worth $7.5 million, and it is expected to rise 20% annually to $18.7 million by 2017. Telemedicine can provide low-cost consultation and diagnostic facilities to the remotest areas via high-speed Internet and telecommunications, thus, bridging the rural-urban divide. In addition, India's extensive mobile technology infrastructure and better connectivity infrastructure is expected to drive mobile health (mHealth) adoption further. He points, "Several people in our country do not have ready access to decent healthcare. There are many challenges to set up a full-fledged hospital at remote and rural locations. However, IoT-based wireless solutions are now making it possible for doctors based in cities to monitor patients located in remote villages. Now, villagers need not travel long distances to get a simple diagnosis done." Mr Pratyush feels that solutions need not involve complex ICT infrastructure. "SMS-based solutions are enabling doctors and hospitals to send reminders and alerts to their patients on medication or health checkups. "This management of medication through SMS platform ensures doctors and hospitals provide best possible care to their patients," he adds. Challenges To Disruption Despite being an IT-enabled services behemoth, the use of ICT in the healthcare sector is limited in India. The major users of ICT include big pharmaceutical companies, corporate hospitals and other private health sector institutions, while the public healthcare sector is lagging way behind in IT utilization. But the good news is that the situation is changing. Mr Pratyush mentions, "Though ICT solutions have had a positive impact on the healthcare sector, there are some challenges that need to be overcome in order to provide affordable, high-quality healthcare solutions, and innovations to hospitals and their vendor ecosystem, doctors, and eventually the citizens of this country." The Government is now cognizant that technology can help overcome challenges arising due to geographical size, high-population density, lack of healthcare infrastructure, inaccessibility in rural India, poor nutritional conditions, and low literacy, among others. Furthermore, the National Health Policy endorsed by the Parliament of India encourages the introduction of electronic communication media in health sector. The Government of India also brought in the National Rural Health Mission for delivering the best-in-class healthcare facilities to the rural population. The Ministry of Health and Family Welfare and the Ministry of Communication and Information Technology are jointly creating a national health information infrastructure for easy capture and dissemination of health information. Like all new disruptive technologies, IoT deployments face numerous challenges. "With connected IoT devices, reliable bidirectional signaling is essential for collecting and routing data between devices. You need to be 100% sure that that stream of data is going to arrive at its destination every time," emphasizes Mr Pratyush. Security is another important factor in IoT connectivity. "What good is a smart home if anyone can unlock your doors, or for that matter anyone can access your health records?" asks Mr Pratyush. "Solutions need to ensure that when sending or receiving a stream of data, the IoT device or server has proper authorization to send or receive that stream of data, and most importantly, you need end-to-end encryption between devices and servers." Huge and uninterrupted power consumption is also seen to pose challenges. "Billions of IoT devices which are required to transmit data between one another will require uninterrupted power either through the grid or battery bank," he stresses. Currently most solutions deployed in the country are based on proprietary technologies which make it difficult for customers to scale or opt out in case the solutions are not working for them. Tata Teleservices is working with partners to create innovative ICT solutions for the healthcare Industry. These solutions address the basic needs of providing telecom infrastructure as well as more complex IoT solutions such as LBS (Location-based services) or healthcare-related applications. Trillion-Dollar Opportunity As far as the IoT market opportunity is concerned, while findings of market research companies may vary, they are unanimous in their conclusion that this is a trillion-dollar opportunity in terms of revenue potential. A recent study by a global networking major predicted that there will be 25 billion devices connected to the internet by 2015, and 50 billion by 2020, thus highlighting its prominence in the coming decade. Mr Pratyush explains, "We have seen IoT and M2M deployments primarily in the utilities and transportation space, but that is changing slowly. As the devices, sensors and application ecosystems grow, we are seeing investments being made across BFSI (Banking, Financial Services and Insurance), retail, healthcare and even the home and building management space. The Government of India is also playing a significant role in adopting 'smart IoT technologies'. The 'Smart Cities' program as well as 'Digital India' is leading entrepreneurs to make substantial investments in this space." Globally, IoT has seen deployments across transport, utilities, retail, logistics, home automation and security. "The West is definitely a few steps ahead in terms of use cases and scale of deployments, but it would be incorrect to say that we are 'very' far behind," he opines. "The next few years will be critical for India, and I believe we have a good opportunity to bridge the gap. The Government's 'Digital India' program and 'Smart Cities' initiatives will further the cause of IoT substantially." The Cloud Adoption Though cloud computing is still a concept that exists only in theory for the Indian healthcare industry, the healthcare vertical has made it to the potential list of every Cloud vendor and service provider. Mr Pratyush says, "It is not surprising, given the general opinion that healthcare industry is rapidly automating itself, and soon enough, will be leapfrogging towards the Cloud." Research agencies like Zinnov have derived that the healthcare industry currently spends only about 2% of their total budgets on IT. This figure is set to grow to 15 to 20% in 2015, and upto 40% in 2020, purely towards adoption of Cloud services. This will mean that the Cloud opportunity within the healthcare segment could touch $600 million in 2020. At a CAGR growth rate pegged at 25%, healthcare is definitely one of the most promising segments as far as Cloud adoption is concerned. Healthcare A Key Vertical Tata Teleservices has been developing IoT solutions for its customers across a host of use cases and industries which includes the healthcare industry. "Our solutions encompass not only the telecom infrastructure but the devices and application as well in select verticals. Healthcare is a key vertical, and we are working with partners to create solutions which will be beneficial for our customers," concludes Mr Pratyush. It is also working with Government agencies to bring about standardization in the IoT space in India. Tata Docomo and its representatives are playing a leading role in the working groups, setup by the Telecommunication Engineering Center (TEC) in the areas of utilities, LBS, security & surveillance, and more recently, smart cities. ]]> https://biospectrumindia.com/news/97/6204/siemens-healthcare-launches-new-pet-ct-system.html https://biospectrumindia.com/news/97/6204/siemens-healthcare-launches-new-pet-ct-system.html Fri, 18 Dec 2015 11:05:57 +0530 Siemens Healthcare has launched the new versatile and cost-effective Biograph HorizonPET/CT system, which offers premium performance at an attractive total cost of ownership. The system provides clinicians with the capabilities required to serve a broad range of patients and expand into new service areas. It enables the use of all commercially available PET tracers, giving users the ability to address more indications in the specialist fields of oncology, neurology and cardiology. The Biograph Horizon utilises 4mm LSO crystals to provide rapid scintillation with a high-light output, providing excellent image quality using the lowest achievable dose to aid clinicians with visualizing small lesions. This in turn ensures a timely diagnosis which contributes to effective care pathways, helping to reduce patient side effects related to ineffective therapies. The system also offers built-in capabilities that automate routine tasks to increase productivity and streamline workflows. The Quanti•QC runs quality control procedures overnight to save precious clinic time, while scans can be performed in under five minutes, and reconstruction runs alongside acquisition for image delivery just 30 seconds after the scan. Mr Steve Holmes, sales director at Siemens Healthcare said, "At a time when there is a demand to drive down cost while enhancing productivity, Siemens is well placed to support with technology capable of improving care pathways and maximizing investments. The Biograph Horizon provides a cost-effective PET/CT imaging solution that does not compromise on quality. As our smallest PET/CT system, it offers low power requirements and a small footprint to ensure reduced operating and maintenance costs, with the flexibility to meet expanding clinical needs." The Biograph Horizon utilises the syngo.via Molecular Imaging Workplace image processing solution to expand clinical possibilities and help clinicians measure and report with confidence. It offers automated tools to instantly visualize diagnostic information, automate pre-fetching, pre-processing, and display and comparison of previous findings. The ALPHA technology provides automatic registration with organ-based recognition capabilities and EQ/PET feature provides precise calculation of changes in tumour uptake.       ]]> https://biospectrumindia.com/news/97/7513/carestream-launches-new-retrofit-system-.html https://biospectrumindia.com/news/97/7513/carestream-launches-new-retrofit-system-.html Fri, 18 Dec 2015 11:04:53 +0530 Carestream Health announced an affordable new retrofit system that allows small to mid-size hospitals, urgent care centers, orthopedic offices and clinics to upgrade existing rooms or mobile X-ray systems from film or CR to fully featured digital radiography (DR). The CARESTREAM PRO Retrofit System is currently available for order in most countries and will begin shipping in November. "This flexible retrofit system enables value-based healthcare providers to convert existing X-ray systems to a DR system at a very reasonable cost," said Mr Chandan Naphade, general manager - XRS business at Carestream Health. He added, "Facilities across the India can achieve higher image quality and gain rapid image access, which can help enhance patient care and boost productivity." The PRO Retrofit System offers gadolinium detectors for general radiography imaging or cesium iodide detectors for dose-sensitive applications. Users have a choice of wireless or tethered 35 x 43 cm (14 x 17 inch) cassette-size detectors that will fit into an existing bucky or a 43 x 43 cm (17 x 17 inch) fixed* detector. Beam-detect mode eliminates the need for a cable connection to the generator, so image capture begins when the detector senses the X-ray exposure. Wireless detectors enable a highly productive workflow with wireless transmission of images to the capture console, immediate image viewing and manipulation, and the ability to forward images from the console to printers or a PACS. An X-ray exam can be transmitted to a computer or laptop using the detector's access point, or the detector can be connected to a system control unit that provides a continuous signal to one or more detectors. Other options include a Carestream desktop or laptop console. The PRO Retrofit system also includes pre-loaded Carestream VXvue image management software and an Image Suite mini-PACS module that offers Web-based patient scheduling, image review and reporting and flexible archiving solutions.   ]]> https://biospectrumindia.com/interviews/97/5180/indian-market-has-a-promising-future-ika.html https://biospectrumindia.com/interviews/97/5180/indian-market-has-a-promising-future-ika.html Thu, 17 Dec 2015 14:01:08 +0530 It first ventured to India in 2008, and has eight locations on four continents across the globe. Mr Erhard Eble, the VP of IKA Group was recently in India and spoke exclusively with BioSpectrum's Raj Gunashekar. He talks about the company's experience in India thus far, the factors that have contributed to its growth, future plans, and the company's strategies for continued success in a challenging market like India. Edited excerpts:Q: What trends do you see in the lab and processing equipments market in India? A: The market in India today is very good and it has tremendous potential opportunity, and we are seeing many more international companies setting up subsidiaries here in India. We have learned that customers in this market require high quality lab and processing equipment and the trend we are seeing at IKA points to success similar to that which we have experienced in major markets such as India.   Q: What were your challenges while entering the Indian market? A: India is geographically a very big country and reaching as many potential customers as possible is very challenging and takes time. So, we established regional sales locations to deliver information faster to customers and have our own on-site service engineers providing the fastest service possible. While our products are the best in their class, the biggest challenge is in expanding that coverage without sacrificing the quality of our service. Q: How do you tackle a price-conscious market like India? A: Customers are price-conscious everywhere. We are a global manufacturer that produces products in India, Malaysia, Brazil, the US and China, and of course, Germany, in order to offer our products worldwide. Our products are produced using only the highest quality materials, to the exacting standards of German engineering. That is why we can say 'made by IKA' with pride, especially with customer service and support that is second to none. Q: Do you see any differences between the German market and the Indian? A: The German market is mature and highly saturated, and IKA has very loyal customers in Germany and throughout Europe because of a long history built on quality and service. But, this is not yet the case in India. If you provide quality and excellent customer service, you will develop a reputation for it and becoming easier over time, to win-over the market. Q: Do you face competition from smaller players in India? A: The competition in India is similar to other world markets. We do have local competitors. We believe, the key to success is to have local offices to provide as much customer support as possible. Q: How did IKA perform financially in the last couple of years? A: Our business is good in Europe and the US, and we have experienced very good growth in China. India is now becoming a significant player and a large contributor to our growth. Sales in China have been stronger, but only because we started there earlier. Q: What has driven IKA's growth here in India? A: The chemical and pharmaceutical industries greatly contributed to our growth. Q: How much of your revenues go into your R&D? A: Our R&D happens in the head office in Staufen, Germany. Several million Euros go into it. Q: Any M&As planned in India? A: M&As are not our strategy. We are a family-owned business as old as history, and our strategy has always been to be innovative in developing new products which fit our customers' needs. We have always developed our own products, and IKA is continually bringing new products to market, and upgrading existing products with new features and functions thereby increasing the suite of products we offer. Q: Tell us about the company's plans in India. A: Our training is done here in Bangalore, where we invite customers, distributors, partners and our service engineers. So, we would like to be present on-site for our customers more. That's our key. We also have close relationships with universities in India, working on the needs of customers. Accordingly, we customize all our products to their needs. This helps us to identify new trends and address market demands. Q: Further expansion to other continents? A: We haven't planned to immediately expand to other continents but we would be open to it, if that market shows to be too-good-to-ignore. We are not too overly conservative at IKA, and we have always kept an eye on the horizon. When we ventured into the US 30 years ago, we did it with a pioneering spirit that succeeded. We are now looking forward to grow, still further in India, because its market is young, dynamic, and has a very promising future. ]]> https://biospectrumindia.com/news/97/4694/illumina-partners-with-novogene-for-ngs-diagnostics.html https://biospectrumindia.com/news/97/4694/illumina-partners-with-novogene-for-ngs-diagnostics.html Thu, 17 Dec 2015 11:10:00 +0530 Novogene and Illumina has announced that they have entered into an agreement to jointly develop advanced clinical applications in the fields of reproductive health and oncology based on next-generation sequencing (NGS) technology. The collaboration signals the increasing importance of genomic applications to improve healthcare in China. In recent years, NGS technology has evolved rapidly and is regarded as an essential factor for enabling precision medicine. The collaboration between Novogene and Illumina will focus on providing the most advanced and integrated sequencing solutions to the clinical market. In particular, the two companies will work together to develop a user-friendly diagnostic system for clinical prenatal DNA and oncology testing in the Chinese market. The collaboration will bring together technology from Illumina sequencers with Novogene's advanced clinical application development capabilities. As part of the agreement, Novogene will provide its nucleic acid extraction, library preparation, and data analysis software, while Illumina will provide NGS instrument components and related reagents. "As a global provider of high-quality genomic services and leading edge bioinformatics solutions, Novogene is pleased to partner with Illumina to advance the application of NGS technology in precision medicine," said Dr Ruiqiang Li, Novogene founder and chief executive officer. "Illumina is very excited to collaborate with Novogene to increase access to genetic sequencing solutions in the fields of reproductive health and oncology testing in China," said Mr Tim Orpin, general manager of the Asia Pacific Region for Illumina. "We are committed to partnering with Chinese companies who share our vision of improving human health by unlocking the power of the genome."   ]]> https://biospectrumindia.com/news/97/4684/trivitron-healthcare-launches-and-patents-newborn-screening-kit-.html https://biospectrumindia.com/news/97/4684/trivitron-healthcare-launches-and-patents-newborn-screening-kit-.html Thu, 17 Dec 2015 11:09:43 +0530 Trivitron Healthcare has launched and patented NeoMass AAAC Kit (CE Approved) for expanded panel of Newborn Screening in India. This is the first kit in the global market that can detect up to 50 disorders that a newborn baby might be born with or without any immediate symptoms or visible manifestations, making it the broadest available panel of biomarkers. The launch of NeoMass AAAC kit makes Trivitron a complete solution provider for NBS with modular systems, automated systems and kits for core panel screening and tandem MS/MS and NeoMass AAAC kit for expanded panel screening. Trivitron aims to create awareness among the target audience about Newborn screening and its alarming need to make it mandatory in India too like other countries. The testing process involves pricking the heel of a newborn baby to collect a few drops of blood on a filter paper within 72 hours of birth and test for detection of life threatening disorders. The launch of NeoMass AAAC kit would lead to screening of inborn metabolic disorders based on a technology called tandem mass spectrometry which allows fast and accurate determination of metabolic disorders. The newly patented NeoMass AAAC kit uses tandem mass spectrometry technology. Dr GSK Velu, chairman and managing director of Trivitron Group of Companies said, "Trivitron Healthcare is one of the largest provider for Newborn screening solutions in the world and our new patented NeoMass AAAC kit is the first kit in the world to detect up to 50 disorder. Trivitron Healthcare is always at the forefront of developing affordable technologies for Indian market." The recently patented methodology makes it possible to detect deficiencies of all the six enzymes involved in the urea cycle metabolic pathway. The urea cycle is a metabolic pathway occurring in the liver and kidney and aberrant functions of the urea cycle enzymes lead to the buildup of ammonia, a product of protein metabolism. If not treated the outcome is very serious with symptoms ranging from vomiting and increasing lethargy to respiratory distress and even coma and death. Additionally, NeoMass AAAC enables an easy and reliable detection of type I tyrosinemia, a serious disease causing dermatologic and neuro developmental problems due to accumulation of tyrosine within the liver and kidney.   ]]> https://biospectrumindia.com/news/97/6962/biomatiques-partners-with-singapore-based-infinity-optics-.html https://biospectrumindia.com/news/97/6962/biomatiques-partners-with-singapore-based-infinity-optics-.html Wed, 16 Dec 2015 13:10:35 +0530 Biomatiques Identification Solutions has partnered with Singapore based Infinity Optics Solutions (IO) to integrate Biometric Extended Depth-of-Field image capture (BEDoF) in the Iris Recognition Technology for the Indian market. The production of this upgraded technology is expected to start from March 2016. The partnership between Biomatiques and Infinity Optics is set to revolutionize the Iris Recognition Technology industry in India by bringing more dynamic user experience to the category of Iris Biometric, and in doing so deliver practical and convenience to the use of Iris Recognition Technology as the biometric of choice. Iris recognition uses random textures that are visible in the eye, using the eye to confirm someone's identity. Unlike voice, fingerprints and facial structure, iris patterns are far more random and unique. An algorithm is created to map the random pattern and then generate unique biometric template for human identification which is unique for every individual. The probability of duplication for voice recognition is 1 in 500, facial recognition - 1 in 1000, fingerprint - 1 in 10,000, Apple touch ID - 1 in 50,000 while in iris recognition, it is 1 in 15,00,000. Mr Tamaal Roy, CEO, Biomatiques said, "It really makes us proud of the fact that we are partnering with Infinity Optics who are the leaders in the market. It is definitely a benefit for us as it has helped us to upgrade the quality of our lenses which will eventually improve the end user experience." IO Solutions' unique and proprietary designs boast a Massive Depth-of-Field vision of up to 5 times. Along with IO Solutions' proprietary lens software, the technology delivers the highest quality image possible. Conventional technology utilizes an auto-focus mechanism and multiple lens construction which is not cost effective. The InfinityLens+ proprietary technology controls the optical aberrations beyond conventional ways of lens design. Mr Alfred Chan, CEO Infinity Optics, added, " We specialize in single lens 'extended depth of field' , something which will replace the conventional method which you so often see in hardware applications where the eye has to move towards or away from the device into a very restrictive and narrow sweet spot. Our solution is designed to allow users to look into the iris recognition device from a normal distance and still obtain a great image for biometric authentication."       ]]> https://biospectrumindia.com/news/97/7910/medtronic-announces-new-high-tech-facility-in-galway.html https://biospectrumindia.com/news/97/7910/medtronic-announces-new-high-tech-facility-in-galway.html Tue, 15 Dec 2015 11:03:28 +0530 Medtronic has announced a new manufacturing facility in Galway, Ireland that will manufacture the market-leading IN.PACT Admiral drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD). PAD is a build-up of plaque in arteries throughout the body leading to reduced blood flow to the limbs, organs, and the brain. Patients with PAD are at higher risk for stroke and heart attack. The decision to locate the new manufacturing facility in Galway is based on the existing high-tech capability and expertise at the site in drug-device combination products for Medtronic's coronary business. Highly skilled professionals from other parts of the Medtronic organization, approximately 100, who specialize in the areas of quality and manufacturing engineering, supply chain and production management, will be stationed in the new facility. The announcement was made in Galway with a site-visit from Minister Mr Richard Bruton TD, and Mr Michael Lohan, manager of Medical Technologies Division, IDA Ireland. Mr Tony Semedo, senior vice president and president of the Aortic and Peripheral Vascular business at Medtronic, stated that the investment showed Ireland's importance to Medtronic's overall growth strategy. He added, "Since launching the IN.PACT Admiral DCB in the US market, it has quickly become the fastest adopted DCB technology. In fact, our global market leadership in DCB is driving the need to open the new facility here in Galway to provide more patients access to this highly efficacious and safe treatment option for peripheral arterial disease. Our Galway operations and staff have very specific expertise in this area, which is the platform for this announcement. Once fully operational, this facility will be the only DCB manufacturing area of its kind in Medtronic worldwide. Our organization is on an expansionary path, with a notable amount of this growth to be fuelled by products coming out of Ireland." Medtronic continues to see additional synergies since the acquisition of Covidien. With the IN.PACT Admiral DCB US launch the week following the acquisition, Medtronic was able to leverage the combined sales force to get this product to market faster.   The facility will have 20,000 square feet of space with 8,000 square feet dedicated to manufacturing and will cost approximately €13 million (or approx $14.32 million). It has been specifically designed to meet the needs of the manufacturing process associated with the IN.PACT Admiral drug-coated balloon (DCB), which is used for the interventional treatment of peripheral artery disease (PAD) in the upper leg. This is a serious and common cardiovascular condition that affects more than 202 million people worldwide. IN.PACT Admiral drug-coated balloon (DCB) is designed to reopen superficial femoral and popliteal arteries that have been narrowed or blocked by plaque. The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, and the paclitaxel drug is intended to prevent artery narrowing by minimizing scar tissue formation.     ]]> https://biospectrumindia.com/news/97/5865/medtronic-samsung-to-develop-solutions-for-neuromodulation-patients-.html https://biospectrumindia.com/news/97/5865/medtronic-samsung-to-develop-solutions-for-neuromodulation-patients-.html Mon, 14 Dec 2015 11:59:04 +0530 Medtronic and Samsung Electronics has announced a broad-based strategic alliance to accelerate the development of digital health solutions for the millions of people suffering from chronic pain, movement disorders, incontinence, and other conditions who could benefit from neuromodulation therapy. The alliance will leverage Samsung's deep understanding of consumer technology and mobility to develop advanced tools, based on the Android operating system, aimed at improving how patients and physicians interact with and receive data from Medtronic's clinically-proven neuromodulation systems. By integrating neuromodulation therapies with Samsung technology, Medtronic seeks to deliver real-time health data to physicians and patients so they can more effectively manage the therapy, track symptoms and wirelessly monitor data received from Medtronic devices. "Medtronic is committed to solving healthcare challenges, and through this alliance we intend to create efficiencies by developing digital solutions that connect patients and healthcare providers in real time," said Mr Tom Tefft, senior vice president and president of Neuromodulation, which is part of the Restorative Therapies Group at Medtronic. "Medtronic has a track record of developing meaningful patient innovations, and this collaboration is the first step to providing more personalized patient care and arming patients and physicians with the best consumer-relevant technologies." In the future, this alliance between Medtronic and Samsung is intended to focus on enabling patients implanted with neuromodulation therapies to use consumer electronics, such as smartphones, wearables or tablets, to securely and wirelessly transmit real-time data from their device to their physicians. Connecting patients and physicians in this manner could provide many potential benefits, including allowing physicians to more quickly make informed, data-driven treatment decisions. "Samsung is applying its deep understanding of how people use technology to bring new innovations to healthcare," said Mr Dave Rhew, chief medical officer and head of healthcare and fitness for Samsung Electronics America. "These future solutions will help better manage the health of patients by providing them with advanced, easy-to-use tools that securely deliver real-time data to their physicians."   In June 2015, Medtronic and Samsung announced a similar collaboration to enable solutions to improve diabetes management for the millions of people at risk and currently living with the disease. The first project focuses on delivering more discreet and convenient access to personal diabetes data by developing mobile applications optimized for Samsung mobile devices that will enable the viewing of insulin pump and continuous glucose monitoring (CGM) sensor information.   ]]> https://biospectrumindia.com/news/97/6960/government-takes-steps-to-delink-medical-devices-from-pharmaceutical-regulations.html https://biospectrumindia.com/news/97/6960/government-takes-steps-to-delink-medical-devices-from-pharmaceutical-regulations.html Mon, 14 Dec 2015 10:53:46 +0530 Responding to the long standing demand of medical device industry to delink it from pharmaceutical sector, the government has taken initial but firm steps towards this finality. The intention to achieve this objective has been spelled out after a meeting of senior officials of MoH and FW, Govt of India and CDSCO with Industry Representatives including AIMED. The ministry will shortly be soliciting public opinion/comments through CDSCO website and issue a notification for change in Drug Rules through the Law Ministry for enabling this de-linkage. It may be noted that the irrational traditional linking of medical device sector with pharmaceutical through common statute and regulatory regime has been a big stumbling block in unlocking the full potential of this critical sector and had contributed to India's humungous import dependency, while scaring away investment. Nowhere in the world are pharmaceutical and medical device sector governed by the same set of legislations as has been historically happening in India. "Indian Medical Devices have for long been incorrectly and incompletely regulated. This has been confusing overseas and Indian investors who were scared to invest with a pharmaceutical type GMP demands being imposed by regulators in an arbitrary and prescriptive manner by unsure inspectors on an engineering industry. The government has taken the first correct strategic steps in the appropriate direction to address the ambiguity" said Mr Rajiv Nath, forum coordinator for AIMED. "Make in India of medical devices is now a possibility if Government also makes it viable and profitable to invest by also simultaneously addressing the adverse inverted duty structure." Mr Nath has pointed out that the next steps to realize the dream of robust domestic medical device industry which is aligned to PM Modi's vision of 'Make in India', it is hoped that country will soon adopt a risk proportionate regulatory framework whereby medical devices of low Patient Safety risk like wheel chairs have a lower regulatory requirement and moderately risky devices like Needles have a higher regulatory requirements and high risk devices like orthopedic implants and cardiac stents have even higher regulatory compliance requirements. This should be followed by unbundling of regulations and regulatory controls whereby the regulators need to delegate the task of compliance audit of manufacturers to Third Party Competent and Accredited Conformity Assessment and Certification Bodies.   "It's impossible for an individual regulatory inspector to have domain knowledge expertise of wide and diverse range of ever changing innovative technologies deployed in producing medical devices from material sciences to biochemistry to metallurgy to atomic sciences to radiology to microbiology to nanotechnology and now wearable digital mobile phone based applications," pointed out Mr Nath. Currently India is import dependent for 70 percent of its devices and lack of an internationally equivalent regulatory framework has been a major factor as investors stood on sidelines watching this market grow unsure of government intent and discouraged by the initial move of 22 medical devices being regulated as drugs by CDSCO and State Drug Controllers. It may also be known that a amendment bill for making required changes in the Drugs & Cosmetic Act, 1940 to enable medical devices to be regulated has been already been tabled in the Parliament and is in the long queue of many Legislations awaited for bringing reforms! "Even that is a half hearted measure whereby our concerns of total delinking with Drugs regulations have not been fully taken into account. There needs to be a separate Law Book - separate Rule Book and separate Regulatory Authority or a revamped CDSCO as an Indian Healthcare Products Regulatory Authority (IHPRA) or regulators may continue to see medical devices from prism of drug regulations if they pick up a common Laws and Rule Book," said Mr Nath . In traditional mode of regulations worldwide earlier, Govt. was the Regulator and prescribed requirements for Manufacturing and directly checked Compliance through Inspectors and directly punished errant Manufacturers thereby creating conflict of interest. As Regulators worldwide are getting increasingly stretched for resources and the required Technical Expertise the various Components of a Regulatory Framework are getting unbundled and India needs to imbibe similar Best Practices and bring in further regulatory reforms for Medical Devices explained a regulatory expert. "Regulations in India need to be layered to separate Role of Legislature from those of a Regulator and those of a supervising Accreditation Body to assist the Regulator, from those of Third Party Conformity Assessment Bodies who will Audit the Manufacturer in line with our honorable Prime Ministers Key Policy principle :Minimum Govt. - Maximum Governance. European Commission and USFDA have already gone this way, In India PNGRB has set an example and FSSAI has all the progressive provisions in its regulations. Such regulatory framework for medical devices will also create higher international acceptance for Indian Products" said Mr Jauhri , CEO of National Accreditation Board for Certification Bodies, Quality Council of India. "In India there has been no onus on manufacturers to demonstrate Compliance. There is a need to provide this layer whereby Manufacturers voluntarily use accredited 3rd Party Conformity Assessment Bodies to verify & certify their Compliance level to regulations," said Mr Jauhri.     ]]> https://biospectrumindia.com/features/97/7574/hottest-new-start-up-consure-medical-.html https://biospectrumindia.com/features/97/7574/hottest-new-start-up-consure-medical-.html Fri, 11 Dec 2015 21:03:41 +0530 Though his first start-up failed in 2004, Mr Nishith Chasmawala's relentless entrepreneurial pursuit today is helping millions of patients worldwide through his new start-up, Consure Medical, which develops novel critical care products. Its first product is a novel device to manage fecal incontinence. The genesis of the New Delhi-based start-up was at the Standord-India Biodesign Fellowship, a program designed to train next-gen medical technology innovators in India. It was at this program both the founders, Mr Nishith Chasmawala and Mr Amit Sharma met together, who are now Consure's CEO and Director of Products respectively. Novel Portfolio Consure Medical was started in 2012. Both the founders were veterans of the medical device industry and have launched novel class II and III devices in the US, EU and Japan.   The start-up is developing and commercializing a novel portfolio of critical care devices that work across a continuum of care settings. Its first product - Qora SMK - provides a novel means to manage fecal incontinence in non-ambulatory patients. Worldwide more than 100 million patients are incontinent each year, and rely on either an absorbent pad (adult diaper) or a fecal drainage device. The use of pads manifests dermatitis, maceration, increases the length of stay, and has direct impact on healthcare costs. Though drainage devices contain fecal exudate in a bag, and hence avoid complications of pads, they have a very narrow indication of use and manifests complications like necrosis and sphincter dysfunction. With the Qora technology, Consure reimagined management of fecal incontinence by developing a novel drainage catheter that can be used with varying stool consistencies or rectal tone on patients across a continuum of care facilities.   More importantly, this technology can be used by a minimally trained person at costs that are comparable or lower than the cost of using a diaper. The patented Qora SMK has been cleared by the USFDA (US Food & Drug Administration), making Consure one of the few medical device companies in India that has its core patents granted in key geographies and regulatory clearances in place. Similar to the latent need of incontinence, Consure today has 4 products in its development pipeline, and is targeting commercial launch of these additional products by the fourth-quarter in 2016. Before starting Consure, Mr Nishith was in charge of the core-technology development team at Kyphon (USA), which was acquired by Medtronic in 2007 for $4.2 billion. He had a great passion to wanting to directly impact the healthcare ecosystem in India, and was exploring ways to come back to India. Mr Amit, prior to joining him, was a founder of a design and development start-up. He was looking out for a more refined focus to create a lasting impact.   Purely from a design perspective, he saw an inherent conflict of interest in a consulting model because, at the cost of amazing product design, clients always gravitated towards a 'fit' within their existing portfolio and business model. He wanted to start a medical device company that was not encumbered by legacy products and addressed latent clinical needs by imbibing brilliant design methodology and user experience. Mr Nishith holds a BS in Plastics Engineering from UMASS Lowell (University of Massachusetts), USA; Mr Amit holds a BS in Mechanical Engineering from Indraprastha University, and a MS in Design from Indian Institute of Technology (IIT) Delhi. Mapping Trends While exploring entrepreneurial opportunities, the founders repeatedly saw three macro trends that increased their curiosity and led to a deeper analysis. "We saw that medical devices are designed, developed and commercialized in silos and nobody had any qualms about it... Due to increased awareness, accountability via regulations, budgetary constraints and smart policies being implemented via Affordable Care Act (Obama Care), we saw that care facilities were getting more cost-conscious when making purchasing decisions," explains Mr Nishith.   Clinical safety, efficacy and regulatory clearances were obligatory requirements for medical device companies. To be commercially successful, companies needed to demonstrate a clear health-economic value proposition of their technologies versus existing standards of care. He continues, "We saw a unique opportunity in developing products for the clinical setting with the least amount of resources and then try to stretch its feasibility all the way up to ICU or trauma care. Again, breaking the silo model to focus on continuum of care and reduce costs." Mr Nishith notes that to overcome legacy health challenges, innovators in India are leading a silent transformation in delivery of health services and access to affordable healthcare. "These models, though at a nascent stage, are a beacon of the shifting healthcare paradigm that other economies can emulate. By virtue of being in India, and with a deep focus on the Indian healthcare market, we saw a unique opportunity to disrupt distribution models to eradicate corruption, expand access to healthcare and alleviate overall health economic costs," observes Mr Nishith. "Mind-mapping of these macro trends and identifying latent clinical needs in different care settings was the genesis of Consure Medical." Lessons From The Past   The founders had learnt a lot from their previous start-ups. "For 2 years Consure was in stealth mode and relied solely on grants and subsidies from government and corporates. During this time, the company focused on one product, completed its development, contract manufacturing and First in Human (FIH) safety study before approaching any investors. Besides capital, the main challenges were lack of local subject matter expertise and lack of a medical device ecosystem," says Mr Nishith. During initial stages, both the founders bootstrapped the company forgoing salary for almost 2 years, and relied on grants and friends in the industry to get to a significant clinical milestone. The Series A investment was led by India Innovation Fund, Indian Angel Network, India Venture Partners and Mr Shrikumar Suryanarayan (Chairman and Co-founder, Sea6 Energy, & former President of R&D at Biocon). Immediately post Series A, the company also secured two international grants enabling the company to extend its runway and aim for a bigger milestone.   Mr Nishith comments, "We are very fortunate to have supportive and patient investors with a long-term focus. Our investors have perfected the art of staying involved and helping out in a very non-intrusive manner. We believe there is always more capital that is chasing fewer good deals in general. Healthcare is considered to a very robust industry from an investment perspective, which augurs well for entrepreneurs that want to create value and make lasting impact to healthcare." Consure has achieved major regulatory and intellectual property milestones in half the timeline of a typical Silicon Valley medtech start-up with about one-tenth the financing over the last three years. IPO-Ready By 2019 At the moment, Consure is targeting intensevists, critical care nurses and CEOs of hospitals. "We make sophisticated devices that are very consumer-centric in design, but still require a prescription for use. We are also in conversations with large distributors and strategic partners to expand commercialization in different geographies," points Mr Nishith. Being an advanced development stage and early commercial stage company, it is executing a customized commercial strategy in India, USA and Japan.   "We have our hands full with India, the US and Japan. Outside of these markets, we will expand along with a strategic partner or a distributor. We are working with index sites and key opinion leaders in India and the US," Mr Nishith reveals. The start-up hopes to be IPO-ready by 2019. He says that New Delhi is a favorable destination for medical devices start-ups. "Gurgaon has the highest concentration of large medical device companies. It also has lots of big hospitals in and around Delhi. There is reasonably strong manufacturing base in Faridabad, Gurgaon, Chandigarh and Baddi in Himachal Pradesh," he states. "Personally for a global medical device company like ours - I like the airport and flight options of Delhi. Probably the best in the country with Mumbai being the second in terms of connectivity." Mr Nishith feels that most medical device entrepreneurs are not interested in entrepreneurship. "They are extremely motivated to solve a clinical problem or commercialize a novel technology, which is usually related to a deep emotional attachment. Often times, being an intrapreneur or collaborating with another company has higher odds of commercial success, than starting up on your own," he ends. ]]> https://biospectrumindia.com/news/97/5995/medtronic-gets-fda-approval-for-the-full-body-mri-system.html https://biospectrumindia.com/news/97/5995/medtronic-gets-fda-approval-for-the-full-body-mri-system.html Thu, 10 Dec 2015 12:01:47 +0530 Medtronic has announced that systems within its Activa portfolio of Deep Brain Stimulation (DBS) neurostimulators have received FDA approval for full-body Magnetic Resonance Imaging (MRI) under specific conditions of use. Medtronic's MR Conditional DBS systems are the only approved for full-body MRI scans. This approval expands access to MRIs, making it safe for patients receiving Medtronic DBS Therapy to also receive this important diagnostic standard of care. Additionally, this approval applies to individuals receiving new Medtronic DBS systems and to an estimated 43,000 people in the US already receiving Medtronic DBS Therapy as long as updated MRI guidelines are followed. With full-body scanning capability, increased MRI RF power limits allow for improved image quality, faster scan times, or larger scan coverage for better diagnostic capabilities. Additionally, when programmed to appropriate stimulation settings and certain other conditions have been met, Medtronic DBS systems allow patients to continue receiving therapy during scans. "The use of MRI as a diagnostic tool has grown significantly, and Medtronic is proud to offer the only DBS systems that allow patients access to full-body MRIs," said Dr Lothar Krinke, vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. "Continuous innovation sets Medtronic apart, and we are allowing greater access to MRIs for those receiving DBS therapy as well as other implanted Medtronic systems such as pacemakers, ICDs and spinal cord stimulators." To ensure devices are safe, Medtronic performed rigorous testing, including developing proprietary test and measurement systems, in conjunction with advanced electromagnetic modeling tools.   Activa DBS systems were tested and evaluated across 10 million simulated patient scans spanning over 38,000 unique implant conditions to demonstrate patient safety. In all, Medtronic has 14 years of MRI research and testing experience.   ]]> https://biospectrumindia.com/news/97/4222/ekano-concept-tailored-to-meet-medtech-needs-in-india.html https://biospectrumindia.com/news/97/4222/ekano-concept-tailored-to-meet-medtech-needs-in-india.html Wed, 09 Dec 2015 14:10:16 +0530 The Ekano concept, created by product design and development firm Cambridge Consultants, is aimed at laparoscopic surgeons in mid-tier and rural hospitals in countries such as India and China. It was developed in Cambridge Consultants' in-house simulated operating theatre, driven by insights gained from in-depth research in Indian hospitals. A team of the company's product development and human factors engineers visited mid-tier and rural hospitals to observe surgical procedures and interview surgeons, nurses and hospital executives to identify unmet needs and innovation opportunities. "We collaborated with surgeons and hospitals in India to drive product feature decisions, with the aim of preserving clinical functionality, improving usability and reducing the cost of ownership," said Rahul Sathe, head of surgical innovation for emerging markets at Cambridge Consultants. "With the cost expected to be around a quarter of existing systems, Ekano can be owned by a surgeon rather than bought by a hospital - complementing the existing business model in India of surgeon consultants owning their own practices and rotating around hospitals on a daily basis." Surgery in emerging markets is strikingly different. In India, for example, mid-tier and rural hospitals are overcrowded and understaffed, and struggle with limited infrastructure - electrical power can go down several times a week. On a daily basis, surgeons use equipment that ranges from brand new to 30 years old - but there's a lack of adequate after-sales training or maintenance support. Surgeons must invest their own money to train on new devices, and then train their nurses and technicians. Hospitals and surgeons seek new products that are easy to learn, use and maintain - and that will enable them to treat more patients, more efficiently, with high-quality, affordable care. Laparoscopy systems enable surgeons to perform minimally invasive surgery via small incisions in the abdomen- reducing patient risk, complications and recovery time. But the sophisticated equipment designed for developed markets is expensive - state-of-the-art systems with 3D cameras and advanced tissue imaging can cost more than £100,000. Such systems are optimised for complex procedures in advanced operating theatres - and so require hospitals to have reliable power, gas lines and integrated electronic medical record (EMR) systems. Surgeons and their staff undergo several years of specialised training to use the equipment. And dedicated technicians are required to service, maintain and replace components. The Ekano console is self-contained and portable - and can be mounted on an IV pole to take up less space in the operating theatre. Size and cost are reduced by incorporating only the product features that are necessary for it to be clinically functional. For example, surgical planning, outcomes tracking and EMR systems are rare in mid-tier hospitals in emerging markets. So, rather than using a complex electronic data management system that takes up significant space, Ekano creates a WiFi hotspot to provide a local EMR for the surgical team. Surgeons can then upload preoperative images via their phone to enable surgical planning with their team - and share data via WhatsApp and other mobile platforms to collaborate with colleagues on challenging cases. Ekano also takes a different approach to visualising anatomy. Rather than using expensive three-chip camera sensors, the camera system consists of a single-chip sensor that uses optical filtering and image processing to provide an optically comparable image at significantly lower cost. Ekano also replaces the traditional large, expensive xenon light sources that need frequent maintenance with a small, compact, LED array to achieve bright yet portable illumination. "We envision the Ekano system using surgical tools with interchangeable tool tips to maximise functionality - in line with the focus in emerging markets on both economic and environmental considerations," said Sathe. "Many surgeons and hospitals in emerging markets prefer not to use disposable surgical products - instead, giving purchasing priority to reusable systems and components. Designing surgical products that can be reused safely - via design for sterilisation and prevention of misuse - is crucial to reduce unnecessary waste and cost. "Needs-driven innovation is key to unlocking business opportunities and advancing surgical care in emerging markets. Countries like India and China offer unprecedented scope for the surgical device industry to deliver quality, affordable care to underserved patients. The Ekano concept demonstrates how the combination of portability, durability, usability and low cost of ownership can disrupt how surgical care is delivered to underserved patient populations." ]]> https://biospectrumindia.com/news/97/6918/another-medical-device-park-to-come-up-in-nagpur-.html https://biospectrumindia.com/news/97/6918/another-medical-device-park-to-come-up-in-nagpur-.html Tue, 08 Dec 2015 14:40:21 +0530 The government is absolutely serious about setting up of country's second exclusive medical device industrial park at Mihan SEZ, Nagpur. The same was conveyed in person to Mr Rajiv Nath, Forum Coordinator, AIMED by Shri Nitin Gadkari, Union Minister for Surface Transport after consulting with Mr Hansraj Gangaram Ahir, Union Minister of State for Chemicals and Fertilizers, Govt of India. Mr Nath and other representatives of AIMED met Shri Nitin Gadkari to discuss the possibility of setting up of country's second proposed exclusive medical device park. After being assured of huge import substitution potential of Rs 23000 crores of imports and even greater potential of exports and preliminary viability, Mr Gadkari asked AIMED to work out the details and other modalities of this project on priority basis. Mr Gadkari assured all support to make the project a super success and also requested AIMED to submit a note of what's needed as a national policy to boost domestic manufacturing of medical devices . It may be known that the country's first proposed medical device park is coming up at Andhra Pradesh, also a result of the initiative of AIMED. Mr Nath has suggested allocation of 200 acres within Mihan SEZ or adjoining it and customizing the facilities to attract a cluster of industries around a common manufacturing facilitation centre with ETO and Gamma Radiation sterilization facility , a high technology machining centre and common tool room , common testing facilities to attract core medical devices possibly other than electronics as the one coming up at Andhra is already being designed to provide special competitive advantage and facilities to electronic medical device manufacturing. "We are extremely happy with this development and the wholesome desire of the government to set up country's second proposed exclusive medical device park. Mr Gadkari's initiave and encouragement is commendable and we all believe that Nagpur is an excellent location for this park to come up as it has all ingredients to make it a world class, internationally competitive manufacturing centre," said Mr Rajiv Nath, Forum Coordinator, AIMED which has advantage for immediate readiness . An AIMED delegation would soon be visiting Mihan SEZ, Nagpur to take first hand stock of location and draw plans for early implementation of government's plan.         ]]> https://biospectrumindia.com/news/97/6961/arterys-ge-partners-for-cardiac-medical-imaging-platform.html https://biospectrumindia.com/news/97/6961/arterys-ge-partners-for-cardiac-medical-imaging-platform.html Tue, 08 Dec 2015 12:05:55 +0530 Arterys, a privately-held medical imaging company providing a SaaS analytics platform that integrates cloud computation and machine learning, has announced the launch of the Arterys System, a revolutionary intelligence platform designed to significantly enhance standard medical imaging. Its first application is in the cardiovascular space, enabling clinical visualization and accurate quantification of blood flow inside the human body. The seven-dimensional data (three in space, one in time, three in velocity direction) input quickly and easily to improve diagnoses in cardiac medicine. The Arterys system was launched at the 101st Scientific Assembly and Annual Meeting of the Radiological Society of North America in Chicago, Illinois, as part of GE Healthcare's ViosWorks, a new comprehensive cardiac solution that reduces magnetic resonance imaging (MRI) assessment to a fraction of the time of conventional cardiac scans. ViosWorks will provide 3D cardiac anatomy, function, and flow in one free-breathing, 10-minute scan with cloud-based, real-time processing of images at resolutions previously unattainable. "We are excited to collaborate with Arterys and introduce this innovative cardiac MR solution that can capture seven-dimensional viewing capabilities of the heart," said Mr Ioannis Panagiotelis, chief marketing officer, Global MR at GE Healthcare. He added, "With cardiovascular disease as the leading cause of death in the world, we believe that this cloud-enabled technology will help us to provide value not only for clinicians by delivering advanced visualization and quantification of cardiovascular function, but also help simplify cardiovascular examinations and address significant patient needs in cardiovascular disease." In November 2015, Arterys and GE Healthcare entered into a partnership to include the Arterys system in new GE Healthcare MRI machines. Financial terms of the agreement were not disclosed.   "We are extremely pleased to announce our partnership with GE Healthcare in conjunction with the launch of our first cardiac care solution, the first self-learning system of its kind to visualize and quantify blood flow leveraging a standard MRI machine," said Dr Fabien Beckers, founder and CEO of Arterys. "This pivotal milestone for the company is directly in line with our vision to transform medical imaging by bringing automatic quantitative data and deep learning to healthcare applications through a GPU smart cloud platform that can be applied to many areas of medical imaging including neurology and oncology." In addition to the launch of the Arterys System, the company completed a $7 million Series A financing led by Emergent Medical Partners, including participation from Norwich Ventures, AME Cloud Ventures, Morado Ventures and Asset Management Ventures.     ]]> https://biospectrumindia.com/news/97/6595/philips-debuts-new-radiology-solutions-at-rsna-2015-.html https://biospectrumindia.com/news/97/6595/philips-debuts-new-radiology-solutions-at-rsna-2015-.html Mon, 07 Dec 2015 11:31:45 +0530 Royal Philips has announced the launch of Radiology Solutions, a fully integrated, consultative approach to enhance radiology practice management. Radiology Solutions comprises customized, data-driven practice management approaches that combine imaging systems, services, informatics and analytics to help radiology practices improve care delivery and reduce costs. Making its debut at the 2015 Radiological Society of North America Annual Meeting (RSNA) in Chicago, Philips' Radiology Solutions will provide radiology practices the critical data insights needed to transform care practices to be more efficient and effective, shaping enhanced operational performance across the entire healthcare network. "The healthcare industry, and radiology in particular, is sitting on vast amounts of operational data - such as imaging procedure settings and utilization - that is not being used to its full potential," said Mr Robert Cascella, CEO, Imaging Business Groups, Philips. "The future of imaging depends on the seamless integration between data and insights across multiple imaging modalities and medical systems, allowing for greater optimization. Closely collaborating with hospitals, like UW Medicine, we've created a solution that unifies data and unlocks actionable information to help influence and improve radiology practice management." Philips' Radiology Solutions offers a comprehensive and scalable data-driven practice management platform that leverages its integrated suite of digital health technology capabilities and breadth of experience in healthcare. Developed in close collaboration with hospitals, including UW Medicine, and powered by the technology of Philips' HealthSuite digital platform, this solution uses data intelligence to spotlight what radiologists need to transform their practices to improve patient care and workflows.   The solution can be tailored for radiology practices of all sizes and used with Philips imaging and informatics products as well as third party imaging systems, PACS (Picture Archiving and Communications System) and RIS (Radiology Information System) systems. "We know that optimizing access, quality, cost effectiveness and impact in a radiology practice brings tremendous value to the patient, the family and the entire health system. Rapid, continuous, optimization in a scalable way requires that large volumes of data are acquired and made visual in a way not previously possible," said Dr Norman Beauchamp, professor and chair of the Department of Radiology at UW Medicine. "That's why we were eager to collaborate with Philips on the development of a platform that takes an integrated approach across, and beyond, a radiology practice. Now we're able to use actionable insights from data to drive improvements, ultimately benefiting patients with higher-quality care." Philips developed Radiology Solutions' data-driven practice management approach with critical input from hospitals to help practices adapt to continuous change and provide ongoing directional support for departmental decision making. Based on the data collected and analyzed from individual assessments, Philips develops a configured integrated solution for practice management which brings together all relevant data inputs for real-time analysis of operations. Philips' Radiology Solutions helps to improve departmental outcomes based on a hospital's or health systems' defined targets in operational and financial performance, and the patient experience. For example, UW Medicine has already identified targeted reductions in radiology exams durations of more than 20 percent. Philips' Radiology Solutions drives automation in the identification of radiology follow-up recommendations and provides the insight to see which patients comply with medical recommendations. Since deploying Philips' Radiology Solutions, UW Medicine uncovered data analysis showing patient compliance to follow-up recommendations were below targets. This data-driven insight allows UW Medicine to identify ways to help its radiologists improve and increase its patient follow-up recommendations compliance.   ]]> https://biospectrumindia.com/news/97/7413/toshiba-ziehm-imaging-partner-for-mobile-c-arm-technology.html https://biospectrumindia.com/news/97/7413/toshiba-ziehm-imaging-partner-for-mobile-c-arm-technology.html Fri, 04 Dec 2015 12:29:25 +0530 Toshiba America Medical Systems is now making mobile C-arms available to its customers in the United States through a new partnership with Ziehm Imaging. This strategic relationship offers customers a broader range of vascular and surgical imaging technologies, with access to innovative mobile C-arms from Ziehm Imaging, while Ziehm Imaging's customers benefit from industry-leading fixed C-arm systems of Toshiba's Infinix product line. Mobile C-arm technology allows for portable and cost-effective solutions for interventional and surgical imaging. Ziehm Imaging, a leader in mobile C-arm technology, offers the flexibility, efficiency and advanced safety features to help Toshiba customers provide the right imaging and treatment for their patient's needs. Additionally, Toshiba's Infinix line will give Ziehm Imaging customers the image quality, flexible system mechanics and patient safety features that are necessary for more complex cases. Product offerings in cardiac, neuro and even combined angiographic and CT imaging will give Ziehm Imaging's customers the right capabilities for a variety of situations. "By listening to customers, we know when mobile C-arm technology will be a good solution for their case mix and when a fixed C-arm solution is the right technology for their procedures," said Mr Satrajit Misra, vice president, Marketing and Strategic Development, Toshiba America Medical Systems. "This agreement means we can now offer a complete solution to U.S. customers so they can deliver the best possible care to patients with no compromise." "We are excited to strategically align ourselves with Toshiba America Medical Systems, to be able to offer US customers best-in-class solutions for both mobile C-arm and fixed imaging solutions for inpatient and outpatient environments," said Mr Johnny Drake, vice president of Sales in the US for Ziehm Imaging.   ]]> https://biospectrumindia.com/news/97/4213/ge-unveils-ge-health-cloud-and-apps.html https://biospectrumindia.com/news/97/4213/ge-unveils-ge-health-cloud-and-apps.html Thu, 03 Dec 2015 14:54:45 +0530 The GE Health Cloud was unveiled at the 101st annual Radiological Society of North America (RSNA) meeting in Chicago. Designed exclusively for the healthcare industry, the new cloud ecosystem and its applications will connect radiologists and clinicians to speed, efficiency and collaboration across care pathways and multidisciplinary teams - both inside and outside the hospital setting. "Our ultimate goal is to help improve patient care and drive superior clinical, financial and operational outcomes alongside healthcare providers," said Mr Jeff Immelt, chairman and CEO of GE. "As the digital industrial leader, we are betting big on the GE Health Cloud. By connecting clinicians with the insights needed, when and where they need them, clinicians can take action to improve healthcare outcomes and delivery around the globe." The new cloud will connect to more than 500,000 GE imaging machines, shifting image post-processing from on-site machines to the cloud. From the cloud, 3-D images can then be viewed on multiple devices - inside and outside the hospital setting. The GE Health Cloud and apps will give clinicians on-demand, flexible computing power that can scale up or down. "Healthcare devices are generating enormous amounts of data, and that data is expected to increase 50-fold by 20204," said Mr John Flannery, president and CEO for GE Healthcare. "The GE Health Cloud can help unlock the value of this data, quickly and seamlessly for better patient care. The GE Health Cloud will help clinicians turn data into insights, and insights into tangible actions for decision-makers to drive better outcomes." By opening its cloud for third party app development, GE intends to attract independent software vendors (ISVs) to develop their apps in the new cloud ecosystem. The new health cloud follows GE's September Minds + Machines announcement of the company's transformation to becoming the world's leading digital industrial company. There, Immelt pointed to new data that revealed a potential 20 percent increase in performance through new software and products powered by Predix, GE's cloud platform. The GE Health Cloud is the first industry-specific cloud to be built on the Predix platform. GE Healthcare announced four new radiology apps at RSNA that will run in the new cloud - all targeted at advanced imaging and clinical collaboration. "Our new apps will bring incredible computing and mobility power to radiologists and clinicians," said Mr Jan De Witte, president and CEO of GE Healthcare IT. "By enhancing radiologists' speed and confidence through the apps, we can help improve their ability to collaborate with referring clinicians inside and outside the hospital." The new apps announced include: •Centricity Cloud Advanced Visualization -This app will manage image post-processing and allow radiologists and clinicians to view advanced 3-D images anytime, anywhere. •Centricity Multi-Disciplinary Team Virtual Meeting- This app will help multidisciplinary teams do collaborative care planning, ultimately helping radiologists and pathologists reduce the time they spend preparing for meetings by up to 20 percent. •Centricity Case Exchange - This latest edition of Centricity Case Exchange will allow affiliated and non-affiliated systems to share images and reports and quickly confer on patient cases and treatment plans. •Centricity Image Access Portal - This app will provide affiliated and non-affiliated physicians with longitudinal patient imaging data, potentially improving turnaround times for patient reports. The GE Health Cloud will use key interoperability standards, including FHIR, HL7 and DICOM - and will have full attestations for HIPAA privacy compliance, and security including HITECH and HITRUST, and SOC2 certification.   ]]> https://biospectrumindia.com/news/97/7164/medtronic-selects-henry-schein-as-distributor-for-diabetes-products.html https://biospectrumindia.com/news/97/7164/medtronic-selects-henry-schein-as-distributor-for-diabetes-products.html Thu, 03 Dec 2015 11:08:54 +0530 Medtronic has selected Henry Schein Medical, the US Medical business of Henry Schein as an exclusive distributor of selected diabetes products to primary care physicians (PCPs) in the US. The exclusive distribution agreement broadens access to Medtronic solutions for people with type 2 diabetes under the care of primary care physicians who oversee their diabetes management. Henry Schein Medical is a leading provider of health care products and services to office-based medical practitioners in the US. Combining Medtronic's expertise in diabetes and Henry Schein's access and reach into PCP offices will help better serve the 27.9 million Americans with type 2 diabetes. Products included in the agreement are the iPro2 Professional Continuous Glucose Monitoring (CGM) system and the i-Port Advance injection port. "Medtronic is committed to advancing the care of people with type 2 diabetes. Solutions such as the iPro2 Professional CGM enable physicians to easily gather valuable insights to make educated therapy decisions and improve patient coaching, which can lead to better control for people with type 2 diabetes1," said Ms Laura Stoltenberg, vice president and general manager, Non-Intensive Diabetes Therapies at Medtronic. "Together with Henry Schein and its dedicated sales team, we can broaden access to CGM for primary care physicians and their patients with type 2 diabetes." The iPro2 Professional CGM provides physicians with valuable insights into how their patients' diet, medication, and daily activities affect glucose levels throughout an entire three-day period.   iPro2 Professional CGM records a patient's glucose levels 24 hours a day for up to three days (a total of 864 glucose readings), and provides user-friendly reports to the physician. Medtronic recently introduced enhanced analytical capability for the iPro2 system. This new functionality, named Pattern Snapshot, helps healthcare professionals, including PCPs, quickly uncover the most important issues to guide and educate their patients on improved glycemic control. "Henry Schein's customers rely on us for the products and services needed to enhance their practice and deliver high-quality patient care," said Mr Dave McKinley, president, Henry Schein Medical. "As exclusive distributor of Medtronic's iPro2 Professional CGM system, along with the i-Port Advance, Henry Schein is pleased to offer our primary care physician customers a complete set of solutions to better care for their patients with type 2 diabetes."     ]]> https://biospectrumindia.com/news/97/1153/fda-clears-siemens-ct-scanners-for-low-dose-lung-cancer-screening-.html https://biospectrumindia.com/news/97/1153/fda-clears-siemens-ct-scanners-for-low-dose-lung-cancer-screening-.html Wed, 02 Dec 2015 11:46:51 +0530 The United States Food and Drug Administration (US FDA) has cleared Siemens Healthcare's SOMATOM computed tomography (CT) systems for low-dose lung cancer screening. From the SOMATOM Scope 16-slice CT system to the ultra-premium SOMATOM Force, Siemens now makes low-dose lung cancer screening broadly available to its customers. "Lung cancer screening represents one of the most significant opportunities to improve population health through earlier detection and improved follow-up opportunities for high-risk patients," said Mr David Pacitti, president of Siemens Healthcare North America. "That's why Siemens pursued the most expansive indication for lung cancer screening, bringing this valuable tool to all varieties of our current SOMATOM CT scanners." The indication for low-dose lung cancer screening is available for the following CT systems: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Perspective, SOMATOM Scope, and the SOMATOM Emotion. Siemens' portfolio of CT systems offers solutions for low-dose lung imaging from screening to detection to diagnosis. With its FAST (Fully Assisting Scanner Technologies) features, Siemens optimizes CT acquisition by reducing user variability. With FAST Planning, technologists can set an optimum range for scan settings that avoids cut-offs or excessive radiation. Its CARE (Combined Applications to Reduce Exposure) feature delivers a consistent, reproducible approach to optimizing radiation dose in scan parameters that supports efficient clinical workflow. Features in the SOMATOM portfolio also aid the radiologist in reporting dose and sharing findings within the interdisciplinary lung cancer team.   Siemens has also launched a unique mobile imaging solution for lung cancer screening - especially for people living in rural areas. The Mobile SOMATOM Scope CT is a self-powered mobile CT with on-board diesel generator that is ready to scan within minutes of parking. No Commercial Driver's License is required to drive the vehicle, reducing complexity in logistics. Equipped with a high-speed wireless connection, the Mobile SOMATOM Scope CT is ready for fast and easy image transfer.     ]]> https://biospectrumindia.com/news/97/7590/toshiba-introduces-new-ultrasound-system.html https://biospectrumindia.com/news/97/7590/toshiba-introduces-new-ultrasound-system.html Wed, 02 Dec 2015 11:46:30 +0530 Toshiba America Medical Systems introduces the newest addition to its ultrasound portfolio. The Xario 100 is a small, versatile and easy-to-use ultrasound system that is ideal for any clinical setting in small hospitals, clinics, private offices and imaging centers. The Xario 100 features a 19-inch LCD monitor with advanced imaging technologies that come from Toshiba's high-end ultrasound units, including Advanced Dynamic Flow (ADF) and Differential Tissue Harmonics (D-THI). It's designed to increase efficiency with a fully customizable console and Toshiba's iStyle Productivity Suite, an adaptable user interface providing workflow automation tools for faster exams. "Toshiba's Xario 100 puts customers first by combining optimal image quality with easy operation, allowing clinicians to make diagnoses quickly and with confidence," said Ms Maria Piazza, director, Ultrasound Business Unit, Toshiba. She added, "The system's outstanding mobility and consistent high performance across a wide range of clinical applications make it a versatile ultrasound solution for this changing healthcare environment. Amid today's financial pressures, Toshiba is making it possible for healthcare facilities of all sizes to provide quality care to their patients." Toshiba will showcase the Xario 100 ultrasound system at this year's Radiological Society of North America (RSNA) annual meeting in Chicago, November 29 - December 4, 2015 (Booth #7336, North Hall).   ]]> https://biospectrumindia.com/news/97/7282/perkinelmer-launches-vectra-3-system-.html https://biospectrumindia.com/news/97/7282/perkinelmer-launches-vectra-3-system-.html Tue, 01 Dec 2015 12:20:19 +0530 PerkinElmer has announced the launch of its Vectra 3 automated, high-throughput quantitative pathology imaging system. This solution's new seven color multiplexing and visualization capabilities are designed to enable pathologists and oncologists conducting research to gain a deeper level of understanding of disease mechanisms related to new cancer immunotherapy approaches. The Vectra 3 system visualizes, analyses, quantifies and phenotypes immune cells in situ in formalin-fixed paraffin-embedded (FFPE) tissue sections, a process that can help provide researchers critical insight into the role of immune cells within solid tumors and the tumor microenvironment. It incorporates 10x whole slide imaging and the Phenochart whole slide viewer, allowing researchers to annotate and navigate slides with interactive interfaces to better identify regions of interest for detailed multispectral acquisition. Unlike alternative instrumentation, limited by the number of colors that can be imaged on one slide, the Vectra 3 system can separate up to seven colors. This multiplexing capability enables identification and quantification of multiple biomarkers and reveals spatial context within a digital workflow to assist researchers with better, faster decisions. "With its ability to resolve multiple biomarkers in a single tissue section, this new system provides an innovative approach to help researchers more deeply analyze cancer mechanisms and potentially develop breakthrough immunotherapies for better health outcomes," said Mr Brian Kim, president, lifesciences and technology, PerkinElmer. "The information may eventually allow for improved stratification of patients for clinical research, further unlocking the potential of precision medicine." The Vectra 3 system is part of PerkinElmer's Phenoptics workflow solutions for quantitative pathology research applications. Phenoptics solutions help researchers fully characterize immune cells and tumor cells in situ within tissue, enabling visualization and analysis of complex cell interactions in ways that are difficult to achieve with other methods. Combined with PerkinElmer's inForm image analysis software, which automatically identifies and quantifies cell populations in tissue, the Vectra 3 system provides researchers the power of multiplexed biomarker imaging and quantitative analysis within a familiar digital workflow. PerkinElmer's Phenoptics portfolio also includes the Mantraquantitative pathology workstation, Opal research kits, and inForm software.   ]]> https://biospectrumindia.com/news/97/7797/becton-dickinson-accused-for-indulging-in-unfair-practices-by-cci-.html https://biospectrumindia.com/news/97/7797/becton-dickinson-accused-for-indulging-in-unfair-practices-by-cci-.html Mon, 30 Nov 2015 11:24:24 +0530 Competition Commission India (CCI) has ordered an investigation against Becton Dickinson India for alleged anti-competitive practices with respect to healthcare services. Becton Dickinson, an MNC that makes disposable syringe under the brand name 'Emerald', has been accused for selling disposable syringe on higher MRP to hospitals and sell same product with lower price in open market. According to Mr Bejon Mishra , a consumer activist from the organisation, Partnership for Safe Medicine said, "Such kind of collusion between manufacturers and importers and hospitals of variable and arbitrary price fixation to fleece consumers indicates the need for government to step in to protect consumers with a price capping mechanism or a taxation by importer or manufacturer linked the MRP as these innocent gullible consumers have no idea about prices of competing medical devices and rely solely on the printed price or their faith in the hospital or doctor." The Commission has ordered a detailed probe by its investigation arm Director General (DG) after finding "prima facie" case of contravening competition norms. According to the Commission, the informant is primarily aggrieved by the conduct of the opposite parties in charging a higher MRP for disposable syringe manufactured by Becton Dickinson India (OP 1) and brought from an in house pharmacy located within the hospital network of Max Super Speciality Hospital (OP 2).   The price was found to be higher compared to MRP (Maximum Retail Price) of the same product in the open market. "Prima facie, the Commission is of the considered opinion that the conduct of OP 2 in charging higher price, through printing higher MRP on disposable syringe in connivance with OP 1, from the informant amounts to imposition of unfair price," which is in violation of competition norms," CCI said. Ordering the probe, the Commission said that in case the DG finds that the opposite parties have violated competition norms, then the role of the "officials/ persons" who at the time of such contravention were in-charge and responsible for the conduct of the business, should also be investigated. As per the order dated November 17, CCI is of the view that prima facie there is violation of Section 3 of the Competition Act that pertains to abuse of dominant position. CCI also noted that there is "no force in the arguments advanced by the counsels of OP 2 that DS available in the open market is different from the product sold by OP 2 in terms of packaging and its usefulness at the time of surgery".       ]]> https://biospectrumindia.com/news/97/7283/siemens-receives-fda-clearance-for-multitom-rax-robotic-x-ray-system-.html https://biospectrumindia.com/news/97/7283/siemens-receives-fda-clearance-for-multitom-rax-robotic-x-ray-system-.html Mon, 30 Nov 2015 11:23:53 +0530 Siemens Healthcare has announced that the US Food and Drug Administration (US FDA) has cleared the Multitom Rax (Robotic Advanced X-ray). It is a universal diagnostic imaging system that enables a wide range of examinations in multiple clinical areas from emergency medicine and interventional to pain management and orthopedics, and from conventional 2D radiography to fluoroscopy examinations and angiography applications - all in one room using one X-ray system. The world's first Twin Robotic X-ray system, the Multitom Rax boasts a unique design that enables, for the first time, the acquisition of 3D natural weight-bearing images. "With the Multitom Rax, Siemens is proud to introduce the world's first Twin Robotic X-ray system," said Mr Martin Silverman, VP of X-ray Products at Siemens Healthcare North America. "This universal X-ray system delivers unprecedented versatility for health care facilities. Now, clinicians can perform a multitude of imaging exams in one room without moving the patient. With the Multitom Rax, we're opening a new chapter in X-ray technology." The unique open design of the Multitom Rax Twin Robotic X-ray system features a height-adjustable patient table and two independent, ceiling-mounted robotic arms for the X-ray tube head and the flat-panel detector for almost unlimited positioning freedom anywhere in the room. Both robotic arms can be moved into position automatically or manually with servo motor support to make fine adjustments. While one robotic arm moves the X-ray tube, the other arm carries the 17" x 17" flat panel detector, which can acquire static, dynamic, and Real 3D sequences. The operator is always in control of the system's movement and able to position both robotic arms precisely and safely around the patient. The Multitom Rax Twin Robotic X-ray system enables, for the first time, the acquisition of 3D images under the patient's natural weight-bearing condition - whether they are seated, lying down, or standing. Images acquired in the natural standing position are essential because the knees, pelvis and spinal column appear differently when the patient's body weight is applied compared to when the patient is lying down.   The Multitom Rax's 3D-ready image capabilities can offer better diagnostic and planning certainty than images that do not reflect a natural weight-bearing condition. Conventional 2D X-rays do not always reveal fine hairline fractures in the bone. In cases of a suspected bone fracture, the patient historically has required a computed tomography (CT) 3D image to confirm the diagnosis. With the Multitom Rax Twin Robotic X-ray system, a 3D image can be acquired on the same system, so the patient does not have to wait for a future appointment or be transferred to a CT system. Built-in features like Comprehensive CARE (Combined Applications to Reduce Exposure) and more precise positioning of the system aid in reducing patient radiation dose.     ]]> https://biospectrumindia.com/news/97/7287/leman-instruments-sas-signs-agreement-with-gravity-engineering-systems-.html https://biospectrumindia.com/news/97/7287/leman-instruments-sas-signs-agreement-with-gravity-engineering-systems-.html Mon, 30 Nov 2015 11:23:29 +0530 The European Gas Generator Manufacturer has signed an agreement with Gravity Engineering Systems. Gravity will represent Leman in India and market the products and also provide required service and spares for the same in south India and Maharashtra which is the major industry focus territory. Speaking about the partnership and products Mr Krishna, director, operations, Gravity Engineering said, "We are very happy to announce our partnership, this agreement between us will bring a very good change in the Gas Generator Industry and we are going change the way users think, we are focused on the quality and timely service both Online Support(Using Computer) and physical service support, we provide the best in class gas generators with the most advanced features that will enable the user to have hassle free work lab environment and the users can be rest assured of the safety and purity of the gas as we have a highly specialized quality control system which makes our generators much more powerful and efficient in all aspects." The company's GC Station the single unit GC Gas Generator which is a combination of all three gasses for GC with inbuilt compressors is its specialty. The firm have already been successful in testing the instrument in most of the well known and well equipped laboratories and claim that its generator is as small as the size of a CPU for a computer. As per the company, the USP of their products is its foot print, touch screen facility and remote control functionality using Ethernet port.   ]]> https://biospectrumindia.com/features/97/7711/3d-bio-printing-market-worth-1-82-bn-by-2022.html https://biospectrumindia.com/features/97/7711/3d-bio-printing-market-worth-1-82-bn-by-2022.html Fri, 27 Nov 2015 15:04:42 +0530 The global 3D bio-printing market size was valued at USD 487.0 million in 2014 and is expected to witness significant growth and attention from healthcare researchers over the forecast period due to, the rising incidences of chronic illnesses leading to organ and tissue transplants coupled with increasing life span of individuals and limited number of organ donors. According to market research and consulting firm Grand View Research, advancement in technology and incorporation of IT within the healthcare industry, rising geriatric population base and improving R&D efforts for the sector are likely to serve as high impact rendering drivers for this market. As of 2015, numerous universities and research institutes have begun analyzing the prospects of bio-printed implants, organs and tissue reconstructions. For instance, the Heriot-Watt University of Scotland created a 3D bio-printer capable of printing pluripotent stem cell cultures that may be applied for drug testing. Another example portraying the substantial development is the recently accomplished thyroid gland transplantation in mice by 3D Bio, for treating hypothyroidism.   If results are favorable, the company would start testing it for human use in the next two years. Technologies used in the 3D bio-printing industry include magnetic levitation, inkjet based, syringe based, and laser based 3D bio-printing. Magnetic levitation along with syringe based 3D bio-printers held the largest share in 2014 whereas laser technology is expected to witness the fastest growth. Also, syringe based technology is anticipated to gain higher adaptation over the next seven years. The next generation magnetic levitation 3D bio-printers are expected to solve more that 80% of the current failures encountered along with enhanced speed and precision. Magnetic levitation printers find application in toxicity screening, vascular smooth muscle printing, human cell generation and their drug response management. BioAssay is a company dealing with manufacturing of tissue-like structure which makes use of these printers on a large scale to benefit from magnetic levitation technology. Key applications analyzed in the study include dental, medical, biosensors, bioinks, food and animal product bio-printing and consumer/personal product testing. The medical segment is expected to dominate the market with over 30.0% share in 2022 and cover the regeneration of organs, tissues, implants and prosthetics along with medical pill production. Medical pills are the latest development in the 3D bio-printing market and are expected to witness lucrative growth over the forecast period. This growth may be attributed to the increasing need of medicines and the advantage of fast and cost efficient production of biodrugs using 3D bio-printing. According to various industry experts, the pharmaceutical industry is expected to grow multi-folds, thereby increasing the volume of medical pill production. Aprecia Pharmaceuticals received the first ever USFDA approval for 3D printing of their drug Spritam in August 2015. The drug would have therapeutic action in treatment of epileptic patients. North America is anticipated to dominate the global market in terms of revenue over the forecast period. It held over 35.0% of the market share as of 2014 is expected to grow at CAGR of over 10.0%. Presence of a huge geriatric and chronically ill population within the region coupled with refined healthcare infrastructure and reasonably higher patient disposable income levels are the key drivers of this market. Furthermore, extensive research activities currently conducted within the region are expected to be vital growth factor over the forecast period. The Wake Forest University of North Carolina presented their research for development of customized medication at the American Heart Association Scientific Sessions (AHASS) in November 2015. The pills would be designed according to the biological profile of each patient which includes, organ function capacity, weight, gender and race. Asia Pacific is expected to witness lucrative growth owing to their pioneering presence in development of healthcare IT and quick adaption of technological advancements. Furthermore, rising awareness level, increasing foreign investments within the region for the purpose of research and supportive government initiatives is expected to propel this development over the next seven years. Key players operating in the 3D bio-printing industry include Organovo Holding, Cyfuse Biomedical, BioBots, Luxexcel Group BV, TeVido BioDevices, Aspect Biosystems, 3Dynamics Systems, Stratasys, Voxeljet, Oceanz, Materialise NV, Envision TEC, Bio3D Technologies, Solidscape and others. Most of the market players have formed tie-ups with research institutes and universities that work on grafting and organ regeneration technologies. Also, the players are scheduling various exhibitions and seminars in order to raise awareness regarding the industry globally. ]]> https://biospectrumindia.com/interviews/97/7228/india-will-become-a-leader-in-medtech-space-camtech-director.html https://biospectrumindia.com/interviews/97/7228/india-will-become-a-leader-in-medtech-space-camtech-director.html Fri, 27 Nov 2015 10:41:00 +0530 Its program involves clinical summits, hackathons, innovation awards, entrepreneur bootcamps, accelerator programs, co-creation labs and an online platform to support global health innovators continuously and across geographic boundaries. The director of CAMTech, Ms Elizabeth Bailey, spoke exclusively to BioSpectrum's Raj Gunashekar, voicing her thoughts on India's healthcare challenges, accelerating and commercializing innovations, CAMTech's India plans, collaborations, and addressing India's obstacles in the medtech space. Excerpts: Q: What are the current pressing healthcare challenges that you see in India? A: Through our work in India, and specifically since the launch of the CAMTech INDIA program, CAMTech has identified critical health challenges related to reproductive, maternal and child health (RMNCH) in India. The program aims to accelerate the development and adoption of new technologies to address preventable causes of death among women and children in India.   Specific areas that our events and initiatives have focused on include RMNCH challenges like newborn survival, safe births and family planning. In addition to RMNCH, our hackathon in October 2015 focused on innovation in the diagnosis, prevention and treatment of diabetes in India - a significant area of unmet needs. Q: How are these challenges, according to you, different in India compared to other LMIC countries? Any similarities? A: Neonatal mortality in India contributes to about a quarter of the world's total number of infant deaths each year, and 99% of maternal and newborn deaths occur in the developing world more broadly. While there are differences in the Indian ecosystem, we have seen some exciting opportunities for innovation in India to help solve clinical problems on a global scale. Issues of access to quality care, for example, are not unique to India, but in order for innovations to be successfully adopted here, they need to have local buy-in with an understanding of the local context. This is why CAMTech focuses on sourcing local innovation that involves local stakeholders. As we have seen in recent years, diabetes has become one of the leading causes of death in India, which in turn has serious implications on the healthcare system in India. This has motivated CAMTech to organize events that will work with local innovators in India to develop solutions that will help to address the epidemic in this country. Q: How is CAMTech involved in addressing these challenges? A: The process begins by identifying specific clinical challenges from our network of clinical, academic and industry partners. We work to tackle these challenges through medical technology hackathons and funding programs, which act as a way to crowdsource innovation and bring game-changing technological solutions forward. The most promising of these solutions are sourced and developed through CAMTech's ecosystem of incubation resources that help build and foster entrepreneurial capacity. Our program involves clinical summits, hackathons, innovation awards, entrepreneur bootcamps, accelerator programs, co-creation labs and an online platform to support global health innovators continuously and across geographic boundaries. Q: How do you view India's medtech landscape? How does it fare at the moment compared to the West? A: We see so much promise in India's medtech landscape. The passion and talent alone is unprecedented, and the entrepreneurial culture seems to be gaining momentum. What has been most exciting is to see how much innovators can accomplish, even with limited resources, compared to groups in the West. It is much more expensive to do business and launch ventures in the West, and I think India has a real competitive advantage because of the lower cost of doing business. I have no doubt that India will become a leader in the medtech space over the next decade, and it will have a huge impact not only on India but on other emerging and developing countries as well. And we see enormous potential for reverse innovation where new health technologies coming from India can help to reduce costs and improve the quality of care in markets like the US. Q: In India, what are the major challenges that you have experienced in moving an innovation forward? A: The entire CAMTech team and all of our partners in India have been really inspired by the community of health innovators across the country. There is a growing network of clinicians, engineers and entrepreneurs who are passionate about making a difference and improving health in India. The biggest challenge however, seems to be the fragmentation of the medtech innovation ecosystem. There are many people and organizations in India doing meaningful and impactful work, but they are not always able to work cohesively. One of the primary goals of the CAMTech program has been to bring these disparate groups together to work more collaboratively to accelerate the whole process of innovation. There has also been a dearth of resources and support for early-stage health innovators, and we are keenly focused on filling that gap with things like increasing mentorship, funding, technical assistance and partnership opportunities for Indian innovators. Q: Briefly explain what are the key elements needed to successfully accelerate healthcare medtech innovations in India. A: First and foremost, we want to start with real and identified clinical challenges. All too often, technologies are developed in isolation from clinicians, and that is why we have ended up with many technologies that are not used despite being available. CAMTech works closely with our clinical partners to identify challenges and have those drive the technology innovation process. We also believe that successful technologies incorporate business, medicine and technology right from the start. Successful innovations are ones that are not only technically-innovative, but also clinically-impactful and commercially-viable. No one group or discipline should be innovating in isolation, and cross-disciplinary teams are the ones who are most successful and expedite the entire process. In terms of what early-stage innovators need in this space, we often hear that there is not a roadmap or clear place to go to get guidance or needed information or resources. CAMTech and our partners are working to create an ecosystem that can support global health innovators through the entire process of technology development, commercialization and market adoption and scale. Q: Currently how does the healthcare entrepreneurship scene look like in India? A: As I've mentioned, the innovator community in India and their desire to make a difference has inspired us. We do hear from those in our innovator network that it's not necessarily celebrated to become an entrepreneur, and that parental expectations influence many people to take a more traditional professional path. We see that changing, however, but it has been slower outside of internet start-ups and particularly slow in the medtech space. The more that industry, government bodies and academia can do to promote and celebrate entrepreneurship, the more health start-ups we'll see. The passion is definitely there, but they also need a little push to get comfortable with all the risks a start-up presents. Q: Tell us about your key partners and the role they play in helping healthcare innovations. A: CAMTech's broad range of clinical, academic and industry partners play a large role in the success and impact that our organization has in India and throughout the world. Our partners provide ongoing clinical expertise and problem identification, event sponsorship, as well as mentorship, monetary awards and incubation support to global health innovators. Some of our key partners in India include Lattice Innovations, who plays an integral role in the planning and implementation of our events; the Public Health Foundation of India (PHFI) and Lata Medical Research Foundation (LMRF), whose expertise and experience within diverse clinical backgrounds has helped identify high-priority clinical challenges in India; GE Healthcare India, who has served as host for two CAMTech INDIA events, and the Federation of Indian Chambers of Commerce and Industry (FICCI), which provides a unique opportunity for hackathon teams to compete for a monetary reward as well as mentorship after the hackathon. The National Health System Resource Center (NHSRC) also offers exciting opportunities in health technology assessment, piloting, connections with industry partners and facilitating a closer relationship between state governments and early-stage innovators. Q: How is CAMTech India supported? A: CAMTech INDIA is supported by the United States Agency for International Development (USAID/India), the Omidyar Network and the Bacca Foundation, in addition to several large medical device and technology companies such as Medtronic, GE, Merck for Mothers, AB InBev, the Novartis Foundation and others. The organization also draws on the expertise of many local partners. Q: Enlighten us about the current happenings at CAMTech. A: In June 2015, CAMTech launched the CAMTech Innovation Platform, which connects global health innovators worldwide with an extensive network of experts (across public health/medicine, technology and business), with a goal to accelerate the development and commercialization of affordable global health technologies and work to enable the entire continuum - from challenge identification to market adoption and scale-up. And diabetes initiative in October 2015 in Hyderabad was sponsored by Marico Innovation Foundation, Terumo and other industry sponsors, with an exciting group of clinical partners including Narayana Health, L V Prasad Eye Institute, the Public Health Foundation of India (PHFI), Madras Diabetes Research Foundation, Apollo Sugar Clinics and Dr Mohan's Diabetes Specialties Centre. Q: So far, tell us about what CAMTech has achieved in India. A: Since its launch, CAMTech INDIA has completed milestone events in Kolkata and Bangalore, including one hackathon at Vellore Institute of Technology (VIT), one open healthcare hackathon and two RMNCH-focused 'Jugaad-a-thons', (how CAMTech refers to its India hackathons). CAMTech INDIA has also organized several clinical site visits, which serve as immersion opportunities for participants prior to the Jugaad-a-thon. The visits enable participants to gain insights into clinical environments and care pathways for women and children, and to better understand physician and hospital workflow. CAMTech INDIA has also hosted two clinical summits, a series of panel discussions that take place prior to the Jugaad-a-thon and feature a diverse group of stakeholders, such as patients, healthcare workers, government officials and public health experts, who are focused on tackling pressing clinical health challenges. Following both clinical summits, CAMTech has held two Technology Showcase events, featuring interactive presentations of early-stage and newly-marketed technologies focused on a particular area of care. Over 500 participants have attended CAMTech INDIA's events and tackled over 150 clinical challenges. During that time, they have created over 100 innovations designed to address critical health problems in the country. Q: Give us an idea about innovations and products that were enabled and accelerated by CAMTech successfully in India. A: Several innovations have come out of CAMTech INDIA events and initiatives, including:  2014 CAMTech India Jugaadathon First Prize Winner BabySteps: a mobile application that aids in early diagnosis of developmental delays in children  2014 CAMTech India Jugaadathon Second Prize Winner PEL-Dia: a measurement system developed to diagnose a condition called Cephalo Pelvic Disproportion - CPD occurs when the baby's head is too large to pass through the mother's pelvis  2015 CAMTech India Jugaad-a-thon First Place and CAMTech/USAID Grand Prize Winner Trust+: a mobile platform for adolescents and adults that encourages open and effective communication about safe sex and family planning  2015 CAMTech India/USAID First Place Winner Team Slow Forward: an effective video consultation for rural areas with low bandwidth  2015 CAMTech India/USAID Second Place Winner Team Peekaboo: an interactive gaming application that aids in identifying vision impairment for children  2015 GE Healthcare India First Place Award Winner Team O2-Matic: a low-cost method for oxygen production to address unpredictable availability of medical gases in limited resource settings Q: Tell us about how you collaborate with Indian academic universities and healthcare organizations? A: CAMTech's academic, clinical and industry partners in India have provided ongoing expertise, funding and participation in our events and initiatives. We seek to engage both public and private sector groups from a range of institutions that will help broaden our reach in the healthcare landscape and support the end-goal of accelerating medical technologies to tackle clinical challenges and move them toward commercialization and impact. Clinical organizations are at the heart of our program, because we want medical technology innovation to start with the clinical challenge and involve clinical end-users throughout the whole process. We also love working with our academic partners, including both students and faculty. Our first academic partner in India - VIT - has been outstanding in terms of supporting their students to engage in the CAMTech program to help drive healthcare innovation in India. They are a stellar example of what university leadership can enable in an academic setting by enabling their students to pursue their interests in healthcare innovation and empower them to chart their own path. Q: Going forward, what is CAMTech's plans in India? A: CAMTech is working to expand its platform in India to look at process and business model innovation in health, in addition to technology innovation. We are looking forward to strengthening our relationships with government groups and other stakeholders to help engage a diverse community of innovators focused on improving health in India and embracing new approaches to innovation. We are also looking to expand our connections to the corporate sector, with both more multinationals and small start-ups who want to be part of an open innovation platform. Good ideas can come from anywhere, so we want to be as broad and inclusive as we can to drive innovation in pursuit of a healthier India. ]]> https://biospectrumindia.com/news/97/8010/dell-announces-monitor-purpose-built-for-healthcare-.html https://biospectrumindia.com/news/97/8010/dell-announces-monitor-purpose-built-for-healthcare-.html Fri, 27 Nov 2015 10:39:38 +0530 Dell has announced the release of the Dell Medical Review 24 Monitor (MR2416), the company's first monitor purpose-built for the healthcare environment. The monitor will debut at the Radiological Society of North America (RSNA)'s 2015 scientific assembly and annual meeting, beginning November 29 in Chicago. "As the number-one monitor brand in the world, we want to bring our innovation and expertise in display technology to the healthcare field with a selection of medical-grade Dell monitors," said Mr Bert Park, vice-president and GM, Dell Global Software and Peripherals. "The MR2416 is the first in a line of products we will be introducing to enable healthcare customers to improve their efficiency and service quality." Each Dell Medical Review 24 Monitor features an anti-reflective edge-to-edge covered glass on the front, and a smooth, fully sealed design that is IP-32 rated. A light-colored exterior makes fluid stains and contaminants easy to detect. In addition, the monitor can withstand cleaning agents of up to 75 percent concentrated ethyl alcohol solution, making it easy to clean and consistent with infection reduction initiatives. The monitor is calibrated to the Digital Imaging and Communications in Medicine (DICOM) part 14 standard grayscale, allowing healthcare professionals to review accurate, consistent images at the point of care. Intelligent backlight stabilization control ensures this DICOM calibration is maintained throughout the monitor's lifecycle. It features 24 inches of diagonal viewing area with 1920 x 1200 resolution (16:10 aspect ratio), providing compatibility with most image-enabled electronic medical or healthcare record (EMR/EHR) applications. While reviewing or sharing images with patients, healthcare professionals can switch the monitor's orientation between landscape and portrait and adjust height, tilt, pivot or swivel the monitor up to 60 degrees left and right with consistent 178-degree by 178-degree viewability from almost any angle for easy screen sharing. The device has also been designed to meet the IEC 60601-1 standard for medical design and safety requirements. The monitor includes features designed to make daily usage easier for healthcare workers, including an active screw-on cable clip to secure cables within the housing as well as mechanical pop-up Power and OSD buttons on the side of the monitor, designed to be easy to find even with gloves on.   As the latest entry from the world's leading monitor brand for two consecutive years, the Dell Medical Review 24 Monitor is backed by Dell's award-winning support, including a three-year Limited Hardware Warranty and Advanced Exchange Service offer that helps hospitals and doctors' offices minimize downtime. Dell is ISO13485 certified for design, development and support of medical displays. It is available for immediate sale in the United States. Call your Dell Sales representative for a quote today.   ]]> https://biospectrumindia.com/news/97/7515/fujifilm-presents-comprehensive-synapse-portfolio-at-rsna-2015.html https://biospectrumindia.com/news/97/7515/fujifilm-presents-comprehensive-synapse-portfolio-at-rsna-2015.html Thu, 26 Nov 2015 11:20:34 +0530 FUJIFILM Medical Systems will showcase its evolving portfolio of Synapse integrated solutions and unveil next generation upgrades at the 101st annual meeting of the Radiological Society of North America (RSNA) held November 29 - December 4, 2015 at McCormick Place in Chicago. "Fujifilm's Synapse solutions are designed to help transform healthcare organizations as they enhance collaboration and optimize workflows across the enterprise," said Mr Jim Morgan, vice-president of Medical Informatics, FUJIFILM Medical Systems. He added, "Our goal is to provide innovative technologies that increase efficiency, boost productivity, and ultimately, help drive quality care and better patient outcomes." The following will be on exhibit and available for demonstration at RSNA Booth #4165: Synapse VNA from FUJIFILM TeraMedica the current KLAS Category Leader for VNA/Image Archive enables management, distribution, and visualization of DICOM and non-DICOM images and standards based documents from any departmental system. The next generation Synapse VNA version 6.0 will debut at RSNA. Major new features include a completely re-designed demographics quality assurance, user interface and support for VNA role-based dashboards. Synapse PACS, the cornerstone of the Synapse integrated solution line, offers new user interface with fast image display, unique Synapse Commonview sharing capability for outside and cloud study transfers, and integration capabilities with other radiology and EHR vendors to optimize workflow. Synapse 3D provides advanced visualization and analysis tools and fully integrates with Synapse PACS, eliminating the need to access advanced diagnostic tools on a separate workstation. Synapse 3D also offers image overlay tools so radiologists can use volumetric imaging to generate 3D models and quantitative analysis of organs. With synchronized patient lists, Synapse 3D is designed to optimize workflow and enhance diagnostic confidence.   Synapse RIS is a full-featured, workflow management system that is fully integrated with Synapse PACS. It features template scheduling, patient portal, business intelligence analytics and has complete EHR certification for Meaningful Use in radiology. Synapse Cardiovascular is a web-based platform that can fit any facility's IT infrastructure and offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas with Synapse VNA version 6.0. It creates finalized, signed cardiovascular-structured reports quickly and easily, and is equipped with a graphical user interface. Synapse Mobility is a zero footprint enterprise viewer that supports VNA with a full suite of collaboration tools and embedded cloud based image sharing that allows clinicians to access patient information anytime, anywhere, from a variety of platforms or using a mobile application. Synapse Mobility provides advanced 3D viewing tools for radiology visualization.   ]]> https://biospectrumindia.com/news/97/7576/government-sets-its-mind-to-reduce-prices-of-medical-devices.html https://biospectrumindia.com/news/97/7576/government-sets-its-mind-to-reduce-prices-of-medical-devices.html Wed, 25 Nov 2015 14:33:14 +0530 Department of Pharmaceuticals (DoP) and Health Ministry Official's meet medical device importers, manufacturers and representatives of Association of Indian Medical Device Industry (AIMED) to discuss the pricing of cardiac stents, pacemarker and implants. Association of Indian Medical Device Industry (AIMED) urged the DoP to move in quickly to curb this malpractice and put in place a transparent and stringent MRP regime for imported goods so that average Indian consumers are not fleeced and retail price parity between domestically produced medical devices and imported products are made competitive based on a transparent labelling mechanism on display of the Maximum Retail Price inclusive of taxes (MRP), which is mandatory in India. At a meeting called by Secretary DOP where representatives of NHSRC, Ministry Of Health , CDSCO and NPPA were present along AIMED, some domestic Indian manufacturers and few implant importers were there in the meeting1- Dept of Pharmaceuticals(DOP) had earlier requested Implant importers and manufactures to consider to self regulate and bring down their MRP by 40-50 percent.2- The importers expressed their inability to make this change.3- The Govt directed all importers and manufacturers to submit their MRP to NPPA ( National Pharmaceutical Pricing Authority) by 30 November and to ensure all unit packs of medical devices carry the MRP - not only the shelf boxes.4- NPPA will thereafter define the price cap on these Implants to address the huge price disparity and to ensure the devices remain affordable and accessible to the common man.5- The AIMED representatives cautioned the Government of the malpractice prevalent in trade of putting removable stickers with MRP on shelf packs / unit packs and being substituted by traders and the need to ensure preprinted prices on unit packs. According to Mr Rajiv Nath, forum coordinator, AIMED, "The malpractice of arbitrary MRP labeling is widely prevalent and the situation is serious enough to warrant immediate government's intervention to rectify the situation. Government has a duty to protect the Indian patients from undue enrichment by unscrupulous traders and manufacturers whereby retail prices go up when ex factory prices are going down and to ensure that there is level playing field between domestically produced medical goods and imported ones. We are very positive that DoP amd Health Ministry will definitely help the industry and the consumers to come out of this serious issue and we have already got positive signals after meeting with the department which held recently." Explaining how price distortion sets in due to flawed or non-existent MRP guidelines and even a more lax implementation of Indian laws regarding this, Mr Bejon Mishra a consumer activist from the organisation , Partnership for Safe Medicine explained that imported medical devices like many other items are imported in bulk and the duty is also paid on bulk and importers claim these are not consumer goods but for hospital use. The government and customs must ensure that all individually packed units for sale of any medical device - big or small even if X-Ray machine, should have the MRP preprinted on the unit pack , there needs to be an import tax of at least one percent on this MRP and the bill of entry and invoice should have the transaction price per unit as well as the MRP per unit to ensure no malpractices of switching of labels post import. Currently importers pay tax on transaction invoice value and not on basis of the MRP.         ]]> https://biospectrumindia.com/news/97/3661/ge-inks-distribution-pact-with-dilon-diagnostics-.html https://biospectrumindia.com/news/97/3661/ge-inks-distribution-pact-with-dilon-diagnostics-.html Wed, 25 Nov 2015 10:46:18 +0530 DILON Diagnostics and GE Healthcare are pleased to announce that they have signed an agreement for DILON to distribute GE's Discovery NM750b Molecular Breast Imaging system in select geographies across the globe. The signing of this distribution agreement will provide Dilon's experienced distribution network access to GE's Discovery NM750b Molecular Breast Imaging system and is considered an initial step in an ongoing exploration of ways to provide better healthcare solutions for clinicians and their patients. The Discovery NM750b breast imaging system, designed to provide significant enhancement in lesion detectability, offers clinicians an important tool for imaging of a broad range of patients, including those with dense breast who may be at higher risk for breast cancer. The power of functional imaging to see early changes is a key factor in early detection in breast cancer. "We are very pleased to associate with GE Healthcare, a world leader in innovation, in the fight against breast cancer," said Dr Robert G Moussa, DILON Diagnostics chairman and CEO. "This relationship will enable us to expand our product portfolio and offer a complete spectrum of BSGI/MBI solutions to better meet the needs of our customers." "We are excited to make the Discovery NM750b breast imaging system further available and to benefit from DILON's global and solid network of sales representatives," said Mr Nathan Hermony, Nuclear Imaging global business manager for GE Healthcare. "GE believes strongly in this advanced technology and the potential for this type of imaging to improve breast cancer diagnosis. DILON Diagnostics resources will bring further the education and acceptance of Molecular Breast Imaging," he adds.     ]]> https://biospectrumindia.com/news/97/7832/thermo-and-partners-to-develop-an-ngs-oncology-test-.html https://biospectrumindia.com/news/97/7832/thermo-and-partners-to-develop-an-ngs-oncology-test-.html Tue, 24 Nov 2015 11:56:14 +0530 Thermo Fisher Scientific has entered into a long-term agreement with Novartis and Pfizer to develop and commercialize a multi-marker, universal next-generation sequencing (NGS) oncology test. The test will serve as a companion diagnostic (CDx) for non-small cell lung cancer (NSCLC) across multiple drug development programs. With many pharmaceutical companies moving toward targeted therapies instead of "one-size-fits-all" drugs, a practical method for matching cancer patients with specific drug candidates is needed to enable the evolution to precision medicine. NGS enables testing of multiple genes simultaneously from a single sample to help identify their unique genetic profile. This information can then be used to guide the appropriate therapy choice among multiple drug candidates. The streamlined and personalized methodology defined in the development agreement between the companies has the potential to improve safety, effectiveness and health outcome of patients via targeted risk stratification and tailored treatment approaches. The collaboration, focused on a universal testing approach, could also accelerate the development and registration of several new NSCLC drugs and drug indications, with the ultimate goal of providing patients greater access to more targeted treatments and appropriate clinical trials as quickly as possible. "We look forward to this collaboration and the future potential of this technology to further enhance the ability to connect patients to the right clinical trials and treatments for them, even those patients with less common tumor mutation types," said Dr Alessandro Riva, global head oncology development and medical affairs, Novartis Oncology. "It is our hope that we will be able to take advantage of this new technology as part of our growing lung cancer portfolio to offer even better outcomes for patients." "We believe that this collaboration will help us get closer to our goal of ensuring that cancer patients are able to benefit from a targeted therapy associated with their tumor's genetic profile," said Dr Hakan Sakul, executive director and head of diagnostics, worldwide R&D, Pfizer. "The Thermo Fisher Scientific NGS panel is aligned with a number of our clinical development programs, providing us with an opportunity to accelerate the development for each of these potential new therapies for NSCLC patients with targetable genetic alterations."   The NGS-based companion diagnostic test for NSCLC will be developed using Thermo Fisher's Ion PGM Dx System and Oncomine assays. Both the NGS platform and Oncomine reagents leverage the Ion AmpliSeq technology, which enables simultaneous sequencing of hundreds of genes, with high reproducibility and rapid turnaround time. Combined with its uniquely low DNA and RNA sample input requirements from Formalin-Fixed Paraffin-Embedded (FFPE) tissues (as little as 10ng extracted nucleic acid per reaction), the Ion Torrent-based sequencing platform and reagents offer comprehensive sequence analysis of a wider variety of tumor samples, including limited or compromised specimens derived from FFPE tissue or fine needle aspirates. Incorporating oncology markers relevant to a broad range of cancers, the NGS panel will also provide a universal platform to enable potential new clinical indications for existing drugs and development of possible new therapies for other indications in the future. "The potential to generate a paradigm shift through this agreement - from one test for one drug, to one test for multiple NSCLC therapies, represents a significant step forward in realizing the promise of precision medicine," said Mr Mark Stevenson, president of life sciences solutions for Thermo Fisher Scientific. "We look forward to building upon our ongoing collaboration with Novartis and Pfizer to lead the efforts in building potential novel NGS testing approaches to advance the future of cancer care."   ]]> https://biospectrumindia.com/news/97/8258/medgenome-appoints-new-ceo.html https://biospectrumindia.com/news/97/8258/medgenome-appoints-new-ceo.html Fri, 20 Nov 2015 13:51:19 +0530 Mr Girish Mehta has previously served as CEO of Oncquest Laboratories and Piramal Diagnostic. He is an alumnus of IIT Mumbai and IIM Kolkata. ]]> https://biospectrumindia.com/news/97/6810/will-indian-pharma-embrace-batch-to-continuous-processing.html https://biospectrumindia.com/news/97/6810/will-indian-pharma-embrace-batch-to-continuous-processing.html Fri, 20 Nov 2015 11:43:00 +0530 STEERLife, incubated since 2013 and rolled- out as an entity in April 2014, is run by MD & chief knowledge officer, Dr Babu Padmanabhan, and chairman Dr Himadri Sen (former research head at Ranbaxy), and has an ambitious goal of reaching the Unicorn status by 2020. The start-up aims to revolutionize the pharmaceutical industry by changing the way medicines are 'made' and 'taken', i.e., to transition from the conventional batch process manufacturing practice to continuous processing (B2C); and from swallowing-to-sipping medicines. The traditional batch processing involves multiple steps including blending, wet granulation, drying, milling, compression and coating. After each of these steps, the product (semi-batch) is collected, quality checked, and then is put through the next process of operation before ending up as a finished product, thereby making the whole process very cumbersome, inefficient, and time-consuming causing environmental hazards. Currently, the pharmaceutical industry employees batch processing method, which is as old as Industrial Revolution, leading to producing products of inconsistent quality, paving way for pharma facilities and manufacturing plants being written-off or shutdown owing to defects, contaminations, or improper testing.   "The manufacturing process adopted by the pharma industry is similar to that of mixing cement and sand to make concrete blocks. In batch processing, it takes several hours with repeated handling and testing of the batch. However, with continuous process, it reduces to anywhere between 3 to 30 seconds. It is a greener technology," said Dr Padmanabhan, while talking to the media at a press conference in Bangalore on November 19, 2015. Dr Janet Woodcock, director, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (USFDA), commented at an American Association of Pharmaceutical Scientists (AAPS) annual meeting in 2011, "Right now, manufacturing experts from the 1950s would easily recognize the pharmaceutical manufacturing processes of today. It is predicted that manufacturing will change in the next 25 years as current manufacturing practices are abandoned in favor of cleaner, flexible, more efficient continuous manufacturing." Right now there are no specific regulations and guidelines for continuous manufacturing or for prohibiting it. Dr Sen said that the USFDA will force the pharma industry to adopt the continuous manufacturing process. "The USFDA will be a facilitator and will request the industry to change from quality-by-testing (QbT) to quality-by-design (QbD)," he added. Advantages of continuous processing include better quality, energy efficiency, lesser waste management and more greener towards the environment.   STEERLife's technologies include Hot Melt Extrusion (HME), Hot Melt Fragmentation (HMF - patent pending), and Activated Granulation. The company's another patent-pending Effervescence Technology (EVT) looks to transform the traditional swallowing of pills to sipping it. Pharma companies can now extend their patents for 3 additional years through introducing the same USFDA-approved drug in a different dosage format, i.e., as effervescent tablets, which is sipped after dissolving in water. Introduction of drugs in a different dosage form is considered as 'dosage innovation'. Generally, the USFDA expects pharma companies to introduce their same approved drugs for Geriatric (older adults) and Pediatric (children) patients in easily ingestible dosage forms. However, companies abandon that option owing to higher cost of production. Dr Sen revealed that the company first intends to introduce its processing technology to MNCs in the US than to Indian companies.   The company's development center in India is located in Bangalore due to high costs involved in the US. In India, the R&D costs is about one-fifth to that of the US. The technology has been developed at its Bangalore development center. An investment of Rs 7-10 crore (US $1.5-2.0 million) has gone into STEERLife through internal approvals within the company. STEERLife so far has been in talks with 4 Indian MNCs and 1 foreign MNC for implementing its technology. The company also targets other industries including nutraceuticals and beverages for implementing its processing technology. It has filed 3 patents which are at various stages in the application process. It usually takes 1.5-2 years for granting a patent. Mr Dipak Chattaraj, ex-chairman of Ranbaxy USA, serves as STEERLife's advisor, and Mr Indu Bhushan as chief technology officer (CTO). Established in 1993, STEER Group creates advanced materials platform technologies for the plastics, pharma, food & nutraceuticals, biomaterials and biorefining industries. It has 5 global offices, 10 satellite offices and 3 application development centers, and employs over 500 professionals.   ]]> https://biospectrumindia.com/news/97/4897/philips-india-appoints-new-md-.html https://biospectrumindia.com/news/97/4897/philips-india-appoints-new-md-.html Wed, 18 Nov 2015 16:57:56 +0530 In his new role, Mr Raja will be responsible for driving and building the Healthcare and Consumer Lifestyle businesses for Philips in India. Mr Raja takes over from Mr A Krishna Kumar, who moved to a new role effective 1st September, 2015 as Head of the Emerging Businesses Group for Philips globally, and is based in Netherlands. Mr Raja brings a wealth of experience spanning over three decades across diverse industries including Healthcare, Consumer Products and Food, in leadership roles in finance, business development, and procurement. He joins from TE Connectivity, where he was the President of India Operations since 2011. Prior to TE Connectivity, Mr Raja worked with GE for 14 years of which 7 years as Business leader of GE Healthcare South Asia and has a proven track record of delivering strong growth and profitability, and nurturing and growing talent.   Mr Ronald de Jong, Chief Market Leader of Royal Philips said, ".....Based upon the solid foundation that was established under Krishna's leadership, Mr Raja will play a key role in further strengthening our position in the Indian market as the leading company in health and well-being." Commenting on his role at Philips India, Mr Raja said, "I am very excited to work with Philips, the company that has been innovating consistently to cater to the needs of modern day customers while maintaining the technological lead that lies at its core since its inception. It will definitely be an enriching experience to be part of a team that is changing the way India defines healthy living." Mr Raja is a Commerce graduate from Kolkata, Chartered Accountant and Company Secretary. Before GE, Raja has worked for other multinationals including Hindustan Unilever for over 8 years.   ]]> https://biospectrumindia.com/news/97/6563/fda-approves-first-app-based-monitoring-system-for-pacemakers-.html https://biospectrumindia.com/news/97/6563/fda-approves-first-app-based-monitoring-system-for-pacemakers-.html Wed, 18 Nov 2015 12:59:19 +0530 Medtronic has announced the US Food and Drug Administration (US FDA) approval and the US commercial availability of the MyCareLink Smart Monitor, the world's first app-based remote monitoring system for patients with implantable pacemakers. With the MyCareLink Smart Monitor, patients with a Medtronic pacemaker can use their own smartphone or tablet technology, with cellular or Wi-Fi service, to securely transmit data from their pacemakers to their physicians, who can then interpret the data to make treatment decisions. The MyCareLink Smart Monitor is comprised of a handheld portable device reader, prescribed by a physician, and the MyCareLink Smart mobile app, available for free on both Android and Apple platforms. When the MyCareLink Smart Monitor is connected to cellular or Wi-Fi service, patients can initiate a transmission of pacemaker data by securely uploading the information to the Medtronic CareLink Network, the world's leading remote monitoring service for cardiac device patients, currently being used by more than one million patients. In addition to sending information from their pacemakers to their physicians or clinics, patients using the MyCareLink Smart Monitor can Confirm the date of their most recent transmission of pacemaker information; create a personalized profile on the MyCareLink Connect Website to manage their pacemaker information and data transmissions and receive email or text reminders, confirmations and notifications of their data transmissions. By connecting patients and physicians, remote cardiac monitoring provides many clinical and economic benefits. These include faster time to treatment if the physician detects a problem with the pacemaker based on the transmitted data; less time spent at a doctor's office or clinic for regular checks of the pacemaker reduced time spent in the hospital if the physician quickly detects and treats a medical problem and a potential increase in patient survival rates. "The use of smart technology continues to grow among people of all ages, and especially among people over 65 which is the age range of the majority of our pacemaker patients," said Mr Darrell Johnson, vice president and general manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic. "As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare. The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement."       ]]> https://biospectrumindia.com/news/97/3169/fujifilm-medical-systems-announces-new-coo-and-cmo.html https://biospectrumindia.com/news/97/3169/fujifilm-medical-systems-announces-new-coo-and-cmo.html Tue, 17 Nov 2015 11:54:20 +0530 FUJIFILM Medical Systems USA has announced that Dr Johann Fernando and Dr Diku Mandavia will join the executive leadership team. Dr Johann was named chief operating officer and Dr Diku was named chief medical officer effective September 28, 2015. "We are pleased to welcome Johann and Diku to join Fujifilm's executive leadership team," said Mr Masataka Akiyama, president and CEO of FUJIFILM Medical Systems USA. "Their broad experience and proven success in the industry will support our efforts to increase customer focus and innovation, enhance strategic and tactical execution, and accelerate growth." As chief operating officer, Dr Fernando will provide day-to-day leadership and management for Sales, Medical Informatics and Modality Solutions Divisions, Business Operations, and Service to help achieve the company's sales and profitability goals and establish sustainable growth. He also leads the effort to expand our Healthcare IT business and drive collaboration across business units. Trained as a medical imaging physicist, Johann has worked in positions of increased responsibility and leadership with Picker and Marconi Medical Systems, Agilent Technologies, ADAC Labs and Philips Healthcare. Most recently he was vice president and general manager for Accuray. Dr Fernando has an MBA from Case Western Reserve University, and a PhD in Radiology Imaging from the University of Texas Southwestern Medical Center. As chief medical officer for FUJIFILM Medical Systems USA and FUJIFILM SonoSite, Dr Mandavia will provide strategic leadership for the healthcare portfolio efforts by overseeing a growing list of activities related to patient care, medical professional networking, and health systems interaction. He joined FUJIFILM SonoSite, as a medical advisor in 2007, is a Clinical Associate Professor of Emergency Medicine at the University of Southern California, and was an Attending Staff Physician at Cedars-Sinai Medical Center, Los Angeles. He is also a founding member and past chair of the ACEP Ultrasound Section, taught thousands of physicians worldwide, lectured at over 150 national and international conferences, has contributed to over 90 publications, and is co-director of the National Resuscitation Conference. He received his medical degree from Memorial University in Canada, and is a graduate of the Stanford Executive Program.   ]]> https://biospectrumindia.com/news/97/8057/ge-emerson-team-up-to-drive-biopharma-manufacturing-efficiency-.html https://biospectrumindia.com/news/97/8057/ge-emerson-team-up-to-drive-biopharma-manufacturing-efficiency-.html Tue, 17 Nov 2015 11:54:02 +0530 GE Healthcare's Life Sciences business and Emerson Process Management has announced a collaboration aimed at increasing productivity and improving efficiency in the production of biopharmaceuticals such as monoclonal antibodies and vaccines. The two companies will collaborate to integrate Emerson's DeltaV distributed control system with GE Healthcare's enterprise offerings and start-to-finish technologies for the global biomanufacturing industry. The first DeltaV-driven GE Healthcare installation, which is expected to be complete before the end of the year, will be a FlexFactory, GE's integrated manufacturing platform based on single-use technologies. Biopharmaceutical manufacturers are increasingly looking to automate production processes, driven by the industry need to increase efficiency and reduce costs. GE's start-to-finish portfolio of single-use bioprocessing technologies already allows manufacturers to reduce set-up times and increase manufacturing flexibility. Emerson's DeltaV system, which uses predictive technologies to connect people, processes and production, enables remote monitoring and control from multiple locations across a company's network and is already widely used in the pharmaceutical industry. The DeltaV system will be offered as an automation control platform for GE's single-use bioprocessing offerings. Mr Emmanuel Ligner, global commercial manager, BioProcess, GE Healthcare Life Sciences, said, "Healthcare providers and the biopharmaceutical industry are facing enormous pressures. Emerson and GE share a vision that an integrated and automated approach to manufacturing has the potential to help drive improvements in production efficiency of these life-saving medicines. This collaboration with Emerson, combined with our depth and breadth of expertise in start-to-finish technologies for bioprocessing, promises to bring real benefits to our customers and to healthcare providers worldwide."   "We believe that the combination of Emerson's automation technologies and the GE FlexFactory will offer superior process performance, consistency of product, and reduced validation time," said Mr Jerry Brown, senior vice president of industry solutions for Emerson Process Management. "This collaboration will support more predictable processes that eliminate unnecessary work, which translates into a reduced time to market for our customers."   ]]> https://biospectrumindia.com/news/97/8107/icgeb-scientist-wins-infosys-prize-2015-.html https://biospectrumindia.com/news/97/8107/icgeb-scientist-wins-infosys-prize-2015-.html Mon, 16 Nov 2015 18:18:01 +0530 In its 7th year now, the coveted prize this year in Life Sciences was awarded to Dr Amit Sharma (47), group leader, structural and computational biology group, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, for his outstanding contributions in deciphering the molecular structure, at the atomic level, of key proteins involved in the biology of pathogenesis of malarial parasite. Dr Sharma has a PhD from Northwestern University, USA, in Protein Crystallography (1995). He then pursued his post-doctoral work at the Oxford University, UK, between 1996-2000, in the area of structural biology. His work on the deadly malarial parasite has the potential value for vaccine design, and development of therapeutics for malaria. The prize consists of cash worth Rs 65 lakh, a 22 karat gold medallion, and a citation certificate. Previously, winners were given a cash prize of Rs 55 lakh.   Mr Shibulal, president, board of trustees, Infosys Science Foundation, attributed this increase to the current currency exchange rates, while addressing the media on the morning of November 16, 2015, during the official awards announcement at the Infosys Campus, Bangalore. The Infosys Science Foundation, a not-for-profit trust created in 2009, has been awarding top minds in research and science across 6 categories to foster a culture of scientific thinking and 'restore the romance of research'. The categories include Engineering and Computer Science, Humanities, Life Sciences, Mathematical Sciences, Physical Sciences and Social Sciences. The Foundation is funded by a corpus which stands at Rs 130 crore (US $20 million), contributed by Infosys' former board directors and senior management. In 2014, under the Life Sciences category, Prof Shubha Tole, an associate professor and principal investigator, department of biological sciences, Tata Institute of Fundamental Research (TIFR), Mumbai, won the award. For 2013, Dr Rajesh Gokhale, director, CSIR-Institute of Genomics and Integrative Biology (CSIR-IGIB), New Delhi, bagged the prize for the same category. The awarding ceremony will be held on February 13, 2016, in New Delhi, with the winners being felicitated by Hon. Indian President Shri Pranab Mukherjee. For 2015, the organization received as many as 206 nominations in all the 6 categories, compared to 136 in 2009. Here is the break-up of nominations:  Engineering and Computer Science: 44 Humanities: 32 Life Sciences: 40 Mathematical Sciences: 27 Physical Sciences: 40 Social Sciences: 23 He pointed that the number of nominations have gone up in the last 7 years. "The winners' work will take time for the impact to materialize. These are fundamental research which will get applied over a period of time," he added. Once a person is nominated, the nomination is valid for 3 years, said Mr Shibulal. "Nominees' merit, their work in India, and an age limit of 50 years, in exceptional situations up to 55, are the basic criteria, and the final decision is taken by the jury," he said. Nominees are always nominated by peers and has the chance to get nominated again by another peer. However, self-nominations are not considered by the jury. When asked about the impact of research works of previous years' winners, Mr Narayan Murthy said, "It is not fair to judge people in such shorter periods of time. In the long-term, we will see their works having tremendous impact on the whole world." He continued, "We have no doubt at all that advancements in scientific research will indeed make India and the world a better place. It makes more sense why we should focus on science, engineering & technology and social sciences, because that's the only way we can create a better world. We have to keep recognizing more and more people who have done excellent work in scientific research... The difference between the rich and poor is coming down. Access to education, healthcare and nutrition has become easier for the poorer masses through advances in science and technology." The winners of the other 5 categories are:  Engineering and Computer Science Prof Umesh Waghmare, Professor - Theoretical Sciences Unit, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Bangalore, India, is awarded for his innovative use of first-principles theories and modeling in insightful investigations of microscopic mechanisms responsible for specific properties of certain materials such as topological insulators, ferro-electrics, multi-ferroics and graphene.  Humanities Prof Jonardon Ganeri, Global Network Visiting Professor of Philosophy, New York University and Recurrent Visiting Professor, Department of Philosophy, King's College London, UK, is awarded for his outstanding scholarship and originality in interpreting and scrutinizing analytical Indian Philosophy and shedding light on shared ground as well as the dichotomy between Indian and Greek traditions of philosophical reasoning.  Mathematical Sciences Prof Mahan Maharaj, Associate Professor of Mathematics, Ramakrishna Mission Vivekananda University, Belur Math, Howrah, India, is awarded for his contributions to geometric group theory, low-dimensional topology and complex geometry. In particular, he established a central conjecture in the Thurston program to study hyperbolic 3-manifolds and introduced important new tools to study fundamental groups of complex manifolds.  Physical Sciences Prof G Ravindra Kumar, Professor, Department of Nuclear and Atomic Physics (DNAP), Tata Institute of Fundamental Research (TIFR), Mumbai, India, is awarded for his pioneering experimental contributions to the physics of high intensity laser matter interactions. In particular for providing, for the first time, unequivocal evidence of turbulent magnetic fields and the discovery of terahertz frequency acoustic waves, in laser produced hot dense plasmas. These results have significance to testing stellar and astrophysical scenarios.  Social Sciences Dr Srinath Raghavan, an ex-military officer, and Senior Fellow, Centre for Policy Research, New Delhi, India, is awarded for outstanding research that synthesizes military history, international politics, and strategic analysis into powerful and imaginative perspectives on India in global context. The winners of the Infosys Prize 2015 were evaluated by a panel of jurors including Prof Pradeep K Khosla (University of California, San Diego, USA) for Engineering and Computer Science; Prof Amartya Sen (Harvard University, USA) for Humanities; Dr Inder Verma (Salk Institute of Biological Sciences, USA) for Life Sciences; Prof Srinivasa S R Varadhan (New York University, USA) for Mathematical Sciences; Prof Shrinivas Kulkarni (California Institute of Technology, USA) for Physical Sciences; and Prof Kaushik Basu (The World Bank, USA) for Social Sciences. ]]> https://biospectrumindia.com/news/97/6898/quintiles-contributes-open-source-code-to-researchkit-.html https://biospectrumindia.com/news/97/6898/quintiles-contributes-open-source-code-to-researchkit-.html Fri, 13 Nov 2015 17:19:23 +0530 Quintiles has announced its contribution of enhancements to the ResearchKit framework which was designed by Apple to make it easy for researchers to gather data more frequently and more accurately from research participants using iPhone apps. ResearchKit enables participants to easily complete tasks or submit surveys right from an app and delivers a simple way to present participants with an interactive informed consent process. Quintiles contributed enhancements to the ResearchKit framework to provide developers with extensions that support additional capabilities which, in turn, will allow them to create more sophisticated application experiences. Quintiles plans to use these enhancements to develop patient engagement tools for ResearchKit-based apps. As the number one ranked late-phase research organization, Quintiles' technology and digital health experts are actively integrating and further enhancing ResearchKit as a tool for its customers' research studies to deliver a superior patient and caregiver experience. "Quintiles has a deep understanding of patient behavior, having conducted more than 400 direct-to-patient programs since 2008," said Quintiles President of Technology and Solutions Mr Richard Thomas. He added, "We embraced those principles in our development of enhancements to the ResearchKit framework." "We believe Quintiles' contribution of these enhancements is a significant advancement within the clinical research industry," Mr Thomas continued. He added, "They will not only improve the apps Quintiles develops for its own use, but can enhance all apps developed using ResearchKit. Working with the ResearchKit framework gives us a profound understanding of its capabilities and how best to optimize it in the apps we develop for our clinical research customers."   ]]> https://biospectrumindia.com/news/97/4513/world-diabetes-day-clinical-trials-for-new-diabetes-drugs-urgently-needed-in-india.html https://biospectrumindia.com/news/97/4513/world-diabetes-day-clinical-trials-for-new-diabetes-drugs-urgently-needed-in-india.html Fri, 13 Nov 2015 14:01:56 +0530 This year the theme is 'Healthy Living and Diabetes'. India has the second highest number of people with diabetes in the world1 with 66.84 million diabetes cases in the country today. An estimated 1 in 12 adults suffer from this lifestyle disease and many cases remain undiagnosed. The ever-increasing diabetes burden has a cascading impact on our nation's health expenditure and healthcare resources. Adopting better diabetes management practices and developing more efficacious treatment for diabetes and its resultant complications are an important need.   There is also an urgent need for investments in more clinical research to ensure that patients can benefit from newer and better medicines says the Indian Society for Clinical Research (ISCR), an association of clinical research professionals. Diabetes is a chronic disease which often leads to a number of complications. Currently not all of these can be treated efficiently with the drugs available. So as new promising molecules emerge and global clinical research is done for these, India's participation will mean faster access to new drugs for diabetics in the country. "The last two years has seen a drop in clinical research being done in the country which has meant delayed access to newer therapies and treatment for our population," said Ms Suneela Thatte, President, ISCR. "Given that India has the largest disease burden in the world, we hope that the recently amended clinical research regulatory guidelines will see more organisations investing in doing clinical research in the country. We have a moral responsibility to ensure that patients in our country have access to newer and better medicines. Given the high incidence of diabetes in India, clinical research will also help identify which medicines work best for our genetic disposition which is critical to managing our growing diabetes burden."   Dr Manoj Chawla, Consultant Diabetologist and Coordinator, Department of Diabetology, Asian Heart institute & Research Centre, an investigator in a recently concluded diabetes clinical trial said, "Given the growing burden of diabetes in our country, it is extremely important for us to test the efficacy of new medicines on our population which is only possible through clinical research. "It is not just patients but we, as investigators, as well who benefit from clinical research because through participating in research, we learn more about newly developed drugs, their benefits and risks. This enables us to play a strong role as global opinion leaders in the safety and efficacy of new drugs for native populations," he added. A patient in Delhi who participated in a diabetes trial (name withheld to protect patient confidentiality) said, "I was advised to enrol in clinical research by my diabetologist. Being diagnosed with diabetes, I went through a very difficult time and it was tough on my family too. "When I was told about the potential benefits of a new diabetes drug which was not available in the market, I decided to participate in a clinical trial and do not regret it." He further said, "It felt good to be surrounded by people who, just like me are fighting this lifelong disease. The trial helped me understand my condition better and the medication I received helped me manage my diabetes more efficiently." ]]> https://biospectrumindia.com/news/97/6551/philips-mackenzie-health-announce-strategic-partnership-.html https://biospectrumindia.com/news/97/6551/philips-mackenzie-health-announce-strategic-partnership-.html Fri, 13 Nov 2015 12:37:47 +0530 Royal Philips and Mackenzie Health has announced a CAD 300 million (approximately $225.457 million), 18-year large scale alliance that will advance Mackenzie Health's medical technology procurement and maintenance programs for the existing Mackenzie Richmond Hill Hospital and the future Mackenzie Vaughan Hospital, which will be completed in 2019. The collaboration is based on a managed equipment services model through which Mackenzie Health will have access to state-of-the art equipment (including those of other vendors) and services for a multi-year term under a single payment structure. This includes procurement, installation, systems integration, maintenance and timely updates to ensure that the hospitals will be provided with the medical technologies that their departments require for the optimal delivery of care. The collaboration further includes a broad range of services including room design, cloud-based predictive analytics and diagnostic technologies. The largest of its kind in Canada, this managed equipment services agreement aims to transform and improve healthcare for over half a million patients in the area. The new 350-bed 'smart' hospital in Vaughan will be the first new hospital to be built in Southwest York Region in more than 50 years. Mackenzie Vaughan Hospital will embrace connected health technologies or the 'Internet of Healthcare Things' to offer a state-of-the-art emergency department, modern surgical services and operating rooms, access to acute inpatient and intensive care beds, technologically-advanced medical imaging, specialized ambulatory clinics and a flexible design, enabling it to evolve as new thinking and best practices emerge. "To bring our 'smart hospital' vision to life, we are partnering with industry leaders like Philips who are at the forefront of innovation," said Mr Altaf Stationwala, president and CEO of Mackenzie Health. "The new Mackenzie Vaughan Hospital has the potential to transform the lives of residents in our community, who are in need of quality care throughout their healthcare journey. We chose Philips not only for their products, but also for their expertise and solutions. Mackenzie Health is committed to working with our healthcare partners to deliver a state-of-the-art hospital as part of our vision to create a world-class health experience for the people of Southwest York Region and beyond."   As a strategic partner, Mackenzie Health will have early and ongoing access to the latest Philips healthcare technology innovations, including access to Philips expertise in areas such as systems interoperability, diagnostic imaging equipment utilization, radiology practice management, patient-centric design, and alarm management. Moreover, both Philips and Mackenzie Health will look at ways that patient informatics can be presented as actionable data that will enable predictive, preventative, and population health interventions. This will not only help ensure continuity of patient care, it will help to effectively improve clinical outcomes for patients, reduce costs, and make healthcare more sustainable both inside the hospital network and into the communities that Mackenzie Health serves. "Forward-thinking organizations such as Mackenzie Health understand that in order to transform healthcare and deliver the type of care their communities need and deserve, they need public-private partnerships with industry-leaders like Philips that have a proven track record of industry expertise and innovation," said Mr Iain Burns, CEO of Philips Canada. "It takes more than just technology to deliver the right solutions, you need to have a deep understanding of the consumer and the healthcare industry to apply best practices for effective patient-centric care. And with this type of large scale partnership, we are an accountable partner, which will ultimately allow Mackenzie Health to focus on doing what they do best: caring for the people in their fast growing community."     ]]> https://biospectrumindia.com/news/97/6980/quintiles-announces-new-chairman-.html https://biospectrumindia.com/news/97/6980/quintiles-announces-new-chairman-.html Fri, 13 Nov 2015 12:37:20 +0530 Quintiles Founder Dr Dennis Gillings will retire from his position as executive chairman of Quintiles Transnational Holdings at the end of this year, December 31, 2015. Dr Gillings will remain on the board as a director. The Board has appointed Mr Jack M Greenberg to serve as chairman of the board, effective January 1, 2016. Dr Gillings took Quintiles public through its first Initial Public Offering (IPO) in 1994, and then led a leveraged buyout to take the company private again in 2003. Quintiles remained a private company for 10 years until its second IPO in 2013. Dr Gillings served as Quintiles CEO for nearly all of the company's first 30 years of operation until current CEO Mr Tom Pike joined the company in 2012. "Quintiles grew very quickly and consistently from its beginnings in 1982," Dr Gillings said. He added, "It has been a memorable ride to get to our multi-billion dollar status today, and I feel privileged to have led this journey. However, I believe there is so much more to come," he continued. "I wish Tom and our management team great success navigating our next era of opportunities so that patients are able to access fast-moving medical advances more easily, timely and cost effectively. Thank you, employees for making all this possible." Quintiles CEO Mr Tom Pike noted Gillings' continuing importance to Quintiles, "There would be no Quintiles without Dennis Gillings. The vision that Dennis displayed in the early years of Quintiles led to a revolution in the way drug development is conducted. He truly was a pioneer in the emergence of the clinical research organization (CRO) industry." "Dennis recognized that a company such as Quintiles could become a true partner with its biopharmaceutical customers rather than a task manager, and provide a plethora of value-added services from product development and commercialization to advisory, regulatory and real-world, late phase services. We are proud to have him as our founder, and will continue to seek his guidance as he continues his work with the Quintiles Board," added Mr Pike.       ]]> https://biospectrumindia.com/news/97/6886/medtronic-launches-venaseal-closure-system-.html https://biospectrumindia.com/news/97/6886/medtronic-launches-venaseal-closure-system-.html Thu, 12 Nov 2015 10:00:00 +0530 Medtronic has announced the US availability of the VenaSeal closure system, the first and only non-tumescent, non-thermal, non-sclerosant procedure approved for the treatment of symptomatic venous reflux in the US. The VenaSeal closure system was approved through the FDA's Pre-Market Approval (PMA) process, and is a minimally invasive procedure that uses a proprietary medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein, in patients with symptomatic venous reflux. Using ultrasound, the physician guides a catheter through a small access site in the leg and into the diseased area of the vein. Once in place, the physician administers the VenaSeal adhesive at various points in a segmental fashion, and with manual compression, closes the vein. Blood is re-routed through other healthy veins in the leg. This unique approach eliminates the risk of burning or nerve injury that is sometimes associated with thermal-based procedures. The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks. In the VeClose trial, patients reported minimal - to - no pain or bruising, post procedure. "Medtronic today furthers our commitment to providing treatment options for patients with symptomatic venous reflux, a disease that can significantly impact quality of life," said Ms Sandra Lesenfants, vice president and general manager of the endoVenous business in Medtronic's Aortic and Peripheral Vascular division. "Thousands of patients have benefited from this procedure around the world, and we are pleased to now offer this advanced technology as an option to our U.S. physicians and patients." The VenaSeal system is currently available in the USA, New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates and Hong Kong.   ]]> https://biospectrumindia.com/news/97/3664/ge-healthcare-buys-the-camden-group.html https://biospectrumindia.com/news/97/3664/ge-healthcare-buys-the-camden-group.html Wed, 11 Nov 2015 11:36:27 +0530 GE Healthcare has announced that it is expanding its US healthcare consulting business with the acquisition of The Camden Group, a population health and strategic advisory firms. GE Healthcare Camden Group will act as the US business unit of GE Healthcare's global advisory firm, GE Healthcare Partners. GE Healthcare Camden Group will be uniquely equipped to enable US healthcare organizations to navigate the transforming healthcare industry by combining The Camden Group's visionary leadership in healthcare consulting for more than 2,000 healthcare organizations with GE Healthcare's clinical and leadership expertise around the world. Terms of the transaction are not being disclosed. "By teaming up with GE Healthcare Partners, the combined firm is one of the largest healthcare consulting firms in the US," said Mr Daniel J Marino, an executive vice-president of the new GE Healthcare Camden Group. "We are positioned well to assist clients as they navigate through post-healthcare reform and transition into value-based care. As a full-service firm, GE Healthcare Camden Group has the ability to provide a broad array of advisory and implementation services delivering distinct advantages and greater impact to our clients." GE Healthcare Camden Group's trusted advisors will be able to help clients transform operational productivity through unique, integrated solutions that combine expertise with complex modeling and financial analytics for powerful, outcomes-based results. The group has deep domain knowledge in hospital operations, physician practice transformation, transactions, performance improvement and change management. Mr Laurent Dubois, CEO of GE Healthcare Partners, said, "Health systems are seeking to deliver care and manage their organizations as effectively as possible. Bringing The Camden Group and its team of industry-recognized thought leaders and advisors into the GE family expands our breadth to support clients not only in the clinical arena, but across entire health systems." The acquisition builds on GE Healthcare's broader mission to develop analytics-based solutions that deliver transformational, enterprise-wide outcomes for healthcare. Last year, GE Healthcare acquired Finnamore and Foresight Partnership to further expand its consultancy and solutions business globally. Ms Laura Jacobs, an executive vice-president of the new GE Healthcare Camden Group said, "This blending of capabilities, experience, and resources creates a unique offering for the healthcare industry. We are excited to join the GE Healthcare family and provide our clients access to the analytics, change management, and activation resources that will support the organizational and clinical changes required to be successful in healthcare now and into the future."   ]]> https://biospectrumindia.com/features/97/7743/newest-hot-start-up-newndras-revolutionizing-jaipurbelt.html https://biospectrumindia.com/features/97/7743/newest-hot-start-up-newndras-revolutionizing-jaipurbelt.html Tue, 10 Nov 2015 13:45:34 +0530 During his school vacations, he had to work at his village farm. He felt excruciating back pain shooting through his body just after a few minutes of working. He realized that this was the tale of every farmer in the country. He says that doctors' advice of getting good rest after a hard labor was next to impossible for farmers and workers. That kick-started within him to think in different ways and try hundreds of attempts to innovate a device that could solve the issue. The end result? The birth of the 'JaipurBelt' (Belt System for Body Support). "I sent my idea to National Innovations Foundation and got the needed support for prototype development and patent filing. Later I sent the details of the functional prototype to Indian Institute of Science in Bangalore for Kishore Vaigyanik Protsahan Yojana (KVPY) Fellowship. I got through them. That gave me enough confidence of commercializing the device. I knew what had to be done but didn't know how and where," recalls Mr Ganesh, co-founder, Newndra Innovations, which was started in 2014. With headquarters in Jaipur, Newndra is a disruptive and frugal innovation-based company involved in commercializing products that has the potential for the betterment of health and lives of people, who are involved in manual labor work.   The company has developed its unique and award-winning flagship 'JaipurBelt' for spinal and waist-related issues. It received a grant support worth Rs 1 million from the Department of Scientific and Industrial Research (DSIR), Government of India. Newndra also took the semi-finalist spot for Anjani Mashelkar Inclusive Innovation Awards 2014. It was also recently invited to attend the 6th Global Entrepreneurship Summit 2015 in Nairobi, Kenya. Recently, Newndra was selected as one among the top-three for the Indo-US Science & Technology Fund. The company is also one of the top 5 finalists in the IMC (Indian Merchant Chambers) Inclusive Innovation Award 2014. Mr Ganesh, the inventor of the belt, says that the company's product will impact billions across the globe, especially for people engaged in agricultural and manual labor. He explains, "Back and waist pain is highly debilitating and affects all individuals regardless of age, ethnicity or economic status. It is a very common problem for a wide range of professions including laborers, farmers, housewives, and the elderly."   It is estimated that more than 90% of the farmers, laborers, and MSME workers' activities involve frequently bending up and down, and commonly suffer from back and spinal disorders. The problem is equally severe in developing and as well as developed countries. Mr Ganesh points that laborers and farmers drink alcohol to relieve their physical pain, which has a consequential effect on their health, social and economic status. In other cases, they are forced to ingest painkillers or have to wear constrictive elastic belts wrapped around their waists. These belts usually restrict the body movements than providing the actual support. He says that painkillers suppress the pain but cannot be a solution. Surgeries of the spine are complex with severe side-effects and prolonged recovery periods. The JaipurBelt, as supporting means, is useful for many applications including manual lifting, frequent bending up and down, or other situations where high levels of stress are applied to the spine and waist.   The device is said to provide physical support up to 80% through its innovative structure without restricting body movements. The belt is apt for labors in intensive industries like manufacturing, MSMEs, construction, farming, agriculture and even highly-paid professionals. Mr Ganesh holds a Bachelor's degree in Information Technology from Jaipur Engineering College & Research Center, Jaipur, and soon thereafter started working as a system engineer with Tata Consultancy Services (TCS) before he plunged into his entrepreneurial journey. Newndra's core team consists of Mr Ganesh Jangir, along with co-founder Dr Anil Jain, who is the head at Dr P K Sethi Rehabilitation Center (SDMH), medical support and clinical studies, Jaipur, and strategist Dr Aalok Pandya. Mr Ganesh reveals that the company has multiple technologies in queue for commercialization. So far, approximately, Rs 30 lakh has gone in building the start-up.   During the initial days, the company battled challenges of having limited resources. "We had to struggle to make things aligned and get the work done. Generally people don't entertain until you show them business or big orders. Big orders are rare at initial stages. It was also difficult to find the right mentors and partners," voices Mr Ganesh. In the next 3 years, it aims to cross revenues of Rs 2 crore. Its current collaborations are with Dr P K Sethi Rehabilitation and Jaipur Foot Centre; and with California-based MedSpark, a medical device design and product development company, as a R&D partner. At the moment, it is seeking manufacturing and global distributors, and collaborations with Governmental and Non-Governmental organizations. Newndra plans to cover the entire Indian market followed by the US, Africa and Europe. He sees areas like powered exoskeleton, human assistive devices, mobile biosensors, and smart watches as the next happening areas in healthcare. According to him, entrepreneurship in India is becoming a hot trend in tier-I and tier-II cities. He adds that cities like Mumbai, Delhi, Pune, Jaipur, and Ahmedabad are great destinations for start-ups. Mr Ganesh firmly believes that innovation and visibility goes hand-in-hand for a start-up. "We trust in innovation and its impact. We put our efforts to innovate and create better impact on the society in order to increase our visibility. Of course, social media, awards and online presence do help," he notes. Top Ways To Raise Start-up Cash:  BIG grants Bi-National Science and Technology Funds Crowdfunding CSR funds Government grants and funds Impact investors  Organizations like Bill & Melinda Gates Foundation and USAID Life Sciences Start-up Myths:  All of them deal with medicines only Founders or CEOs must be doctors or medical pros Have to sell products only through doctors Entrepreneurial Lessons Learnt:  All fruits do not fall at one's wish Takes persistence and sincere hard work Being ready to struggle and do a lot of hard work Never to test the water depth with both legs Entrepreneurial Mistakes To Avoid:  Unrealistic assumptions Improper validation and testing Ignorance No plan-B Relying on traditional funding methods Publishing innovation/product before filing IPR Primary Target Clients:  Industrial workers (MSME, Workshop, Manufacturing) Elderly and aged people (Alternative to walking sticks, walkers, & scooters) Agriculture and people involved in farming activities Construction laborers Medical patients (Patients with Kyphosis, Spondylosis) Secondary Target Clients:  People with waist and spine injuries Motorcycle riders  Vehicle drivers (Motor rickshaw, transport trucks) Defense soldiers (Often carry heavy gear and equipments) Outdoor sports (Mountaineers, bicycle riders) IT/Office-goers (professional and those who have to sit for long duration) ]]> https://biospectrumindia.com/news/97/7046/indias-first-medical-device-park-to-come-up-in-ap.html https://biospectrumindia.com/news/97/7046/indias-first-medical-device-park-to-come-up-in-ap.html Tue, 10 Nov 2015 10:05:00 +0530 Chief Minister of Andhra Pradesh, Mr Chandrababu Naidu has taken in-principle decision to develop a dedicated 200 acre industrial park for the manufacture of medical devices in his state. The decision was conveyed by Mr Naidu himself following an hour-long tripartite meeting between the CM and his senior officials, senior central government officials with the representatives of Indian medical device industry led by Forum Coordinator of Association of Indian Medical Device Manufacturers (AIMED) and Jt. managing director of Hindustan Syringes and Medical Devices,  Mr Rajiv Nath. The Association was able to impress upon Mr Naidu and the Central government representatives as to why it made tremendous sense to have such a facility. In particular, Mr Nath was able to bring out its criticality for the country as well as its contribution for industrial development and employment generation in the state and huge growth potential. Indian medical device industry is worth over Rs 60,000 crore. And country's humungous import bill for this segment amounts to over Rs 23,000 crore (approximately $4 billion) while export amounts to only over Rs 7000 crore ($1.1 billion). India's import dependency on high-end medical devices is over 80 per cent and 60-70 percent for other devices And this is where the dedicated medical device park would be of great value - reducing humongous import dependency, increasing export while generating wealth and employment within. "I am extremely thankful to Chief Minister Shri Chandrababu Naidu for recognizing the opportunity and taking a quick and firm decision to set up India's first medical device park in his state," said Mr Rajiv Nath. "This will be a wonderful opportunity for the state to increase its industrial footprint, create employment while giving a big boost to import substitution for the country. We are truly excited with the decision," added Mr Nath.   Mr Naidu has also assured AIMED representatives that he will personally address any issue over implementation of the decision and looked forward to early commencement of work and for the needful policy support required. Dedicated areas will soon be identified for the medical device park. The Park will be having a Common Manufacturing Facility Centre to act as a Hub for SME Sector to enable it to flourish as a Cluster. Focus will be on creating an Eco System for High End Medical Device Manufacturing and Import Substitution with an eye for Export Market. Shri Sudesh Pant, Jt. secy Dept of Pharmaceutical and Shri Ravi Capoor, Jt secy Dept of Commerce, Government of India along with Dr Poonam Malakondaiah, Health Secretary AP Govt , Mr Kamineni Srinivas Health Minister of Andhra Pradesh and Dr Jitendar Sharma, Advisor to AP Govt. on Health & Medical Technology (also the head of Technology Division of NHSRC, Ministry of Health & Family Welfare, GOI ) were part of the meeting. Apart from Mr Rajiv Nath, the industry was represented Mr A Manikam, Director of Trivitron, Mr Rakesh Shah of Siora Surgicals representing the orthopedic implants and Mr Krishna Prasad President of Prognosys Medical Systems represented the Electronic Sector and Mr. Suresh Sugavanam VP of UL India, the Testing and Certification Fraternity. Central government officials apprised the meeting that the government was working at the highest level to address the issue of inverted duty structure which is stunting growth of this industry and provide preferential market access to boost domestic manufacturing. It was also informed that a new Draft Policy on Medical Device sector was also being worked upon and shortly a National Policy on Medical Device will be released.   ]]> https://biospectrumindia.com/news/97/4168/indias-first-industry-academia-collaborative-partnership-for-medical-devices-rd-takes-shape.html https://biospectrumindia.com/news/97/4168/indias-first-industry-academia-collaborative-partnership-for-medical-devices-rd-takes-shape.html Fri, 06 Nov 2015 16:18:48 +0530 Association of Indian Medical Device Industry (AIMED) has announced the launch of 'UdaiMed', a new sunrise forum for collaborative interface between User, Developer, Academia, Industry and Medical Device Development in India. The objective of this momentous milestone collaboration for academic-industry in India is to make on-campus research more aligned to medical device industry's needs and catalyze 'Make-in-India' program. To take forward this objective, AIMED and UdaiMed also signed its first MoU with TiMed(Technology Business Incubator), a not-for-profit registered society promoted by SreeChitraTirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram,for encouraging innovation and entrepreneurship in medical technologies through technology business incubation support to innovators, start-ups and industry. SreeChitraTirunal Institute is an Institute of 'National Importance' created by an Act of Indian Parliameunt in 1980 and SCTIMST-TiMed is financially supported by the Department of Science & Technology (DST), Government of India and the Kerala State Industrial Development Corporation (KSIDC). Under the terms of new partnership, Shree Chitra will launch TiMeD a 'Technology Business Incubator' with the broad objective of supporting and facilitating innovation, entrepreneurship, start-ups, new product development specifically aimed at medical devices development and biomaterials domain. TiMed will offer office and laboratory space with several common facilities like internet access, library, canteen, video-conferencing facilities for taking forward this collaboration. According to Mr Rajiv Nath, Forum Coordinator for AIMED and a signatory to the MoU between the two bodies, "The partnership between AIMED led UdaiMed and TiMed is a milestone for industry-academia partnership in the country which will foster world class practical research in India, catalyzing Make-in-India mission, help reduce humungous import dependency in medical devices and bring down overall healthcare cost."   Explaining the need for such an initiative, Mr Nath pointed towards the ground realities of campus R&D in India stating that, "R&D institutions and engineering colleges do product development in isolation while industry has little or no idea of work being done there, and often such research have no relevance for industry. Collaboration between institutions and industry is completely absent even as most development is for peer academia acclaim rather than meeting industry's needs or contributing to country's competitive prowess." As a next step, Dr Jitender Sharma, Head of Healthcare Technology Division of NHSRC, MOH&FW (also party to this initiative)said, "AIMED/UdaiMed could request the Government to auction all Patents which are not yet commercialized so that these can be put to use by Indian manufacturers for the benefit of Indian consumers and medical fraternity". Speaking on behalf of SCTIMST-TIMED, Mr BalramSankaran, CEO, said, "Developing and commercializing medical devices is very challenging but extremely critical for competitive edge of our country. The partnership betweenTiMed and UdaiMed will help nurture a much needed eco-system which can deliver great results. We are extremely delighted with this partnership."   ]]> https://biospectrumindia.com/news/97/4517/bosch-signs-mou-with-iisc.html https://biospectrumindia.com/news/97/4517/bosch-signs-mou-with-iisc.html Thu, 05 Nov 2015 14:25:38 +0530 Bosch India has further enhanced its partnership with the Indian Institute of Science (IISc) by signing a memorandum of understanding (MoU) on October 28, 2015. Through this MoU Bosch and IISc will collaborate to address India centric requirements. The signed MoU's were exchanged between Bosch and IISc in the presence of the Hon'ble President of India, Shri Pranab Mukherjee at the Rashtrapati Bhavan, Delhi on November 04, 2015 Commenting on this development, Dr Steffen Berns, president of Bosch Group in India, said, "Based on this MoU we intend to develop solutions that address key India centric requirements. Innovation has always been a special strength of Bosch. This partnership between industry and academia further enforces our ties with the IISc and underlines our commitment towards local innovations, according to our slogan "Invented for life". We expect to see positive results as we collaborate in research on areas of strategic interest, such as mobility, healthcare, energy and water." Professor Anurag Kumar, Director, IISC said, "Robert Bosch Centre for Cyber Physical Systems at IISc has helped define a trail for industry-academia collaboration. With the MoU sign off we look to engage in deeper research that will improve the quality of life in totality." In May 2011, the Bosch Group had announced investments totalling Rs 300 crores to provide support for universities and research projects in Germany, China, India, and the US over a ten year period, as part of its global initiative 'Bosch InterCampus Program'. The program aims to achieve lasting improvements in research conditions for undergraduates and scientists in the university sphere. Approximately Rs 115 crores (22 mio Euro) were allotted for India to accelerate progress in highly promising fields like environmental protection, energy, and mobility. The Robert Bosch Centre for Cyber Physical Systems was setup at IISc with this grant and is currently in its fourth year.   With the signing of the new MoU, Bosch and IISc will deepen their already existing relationship. Commenting on the signing of the new MoU, Mr Vijay Ratnaparkhe, president, Bosch Engineering and Business Solutions said, "These partnerships symbolize Bosch's innovation focus in India. It will increase our problem solving capabilities, and at the same time the collaboration will result in sharing our learnings for the benefit of society. I believe it is absolutely essential for the growth of innovation in India."   ]]> https://biospectrumindia.com/news/97/7145/allergan-to-acquire-a-medtech-firm-earfold.html https://biospectrumindia.com/news/97/7145/allergan-to-acquire-a-medtech-firm-earfold.html Thu, 05 Nov 2015 14:21:58 +0530 Allergan has announced that it has entered into an agreement under which Allergan will acquire Northwood Medical Innovation, developer of innovative implant technology, earFold, an innovative medical device for the correction of prominent ears, with or without asymmetry, in patients aged 7 years and older. earFold received a CE mark in April 2015, and has been made available by Northwood Medical Innovation Ltd to trained and accredited plastic surgeons, otolaryngologists (Ear, Nose and Throat) and maxillo-facial surgeons, primarily in the UK. Upon closure of the deal with Northwood Medical Innovation Ltd, Allergan intends to commercialise the product widely across Europe, in line with its CE mark, and will continue to explore the regulatory pathways and necessary clinical data requirements to commercialise this medical device in other countries, including the United States of America. "Allergan is constantly searching to partner with or acquire companies with disruptive technologies that offer substantive value to our customers, often opening up new categories or setting new trends within our specialist segments. An example of this is the strategic acquisition of KYTHERA, with KYBELLA (marketed as BELKYRA in Canada) (deoxycholic acid) injection, the only FDA approved non-surgical pharmaceutical treatment for reduction of submental fat, or double chins," said Mr Paul Navarre, president and EVP of International Brands at Allergan. He added, "earFold technology adds another innovative product to our medical aesthetics product portfolio, especially for the plastic surgeons we serve today, and has the potential to expand the number of patients interested in corrective surgery as it provides an alternative treatment that may appeal to those who have been reluctant to undergo traditional surgical procedures. Many of Allergan's plastic surgery customers currently perform otoplasty procedures, emphasizing our commitment to serving the unmet needs and practice of plastic surgery." earFold is a small implantable medical device made from a short strip of nitinol metal alloy, which is specifically designed to retain a preset shape. Following injection of a local anaesthetic, it is carefully inserted under the skin using an introducer, and works by gripping the cartilage of the ear, enhancing or creating the shape of the anti-helical fold - thereby reducing the prominence of the ear. Including the initial consultation, the procedure takes about 15-20 minutes to complete and can be performed within an outpatient setting, reducing the risk associated with a general anaesthetic.   Given the preset nature of the nitinol strip, treatment with earFold can deliver a consistently effective outcome. By contrast, otoplasty or pinnaplasty is a complex surgical procedure that requires a visit to a fully-fitted operating suite, requires a general anesthetic and is associated with significant down-time post treatment. The results from otoplasty surgery can be more difficult to predict in advance of surgery as the adjustments to the ear's shape can only happen during the procedure itself and are therefore left to the surgeon to control. "Following a complex outcome after a standard otoplasty procedure, early in my career, I was motivated to develop an alternative approach to correcting prominent ears," said Mr Norbert Kang, consultant plastic surgeon and creator of the earFold. "In my clinical practice, there are a significant number of patients who are reluctant to undergo surgery and so put up with accepting the social hindrance of prominent ears. The beauty of the earFoldTM treatment system is that it offers an evidenced-based alternative to standard otoplasty surgery that may meet the needs of a wider range of patients, by delivering immediate and predictable results, without the risks associated with general anaesthetic." On completion of this deal, Allergan will establish a standardised training programme for surgeons on the earFold treatment system, in order to bring this valuable treatment option to more patients and ensure effective and safe outcomes   ]]> https://biospectrumindia.com/news/97/3826/attune-expands-senior-leadership-team.html https://biospectrumindia.com/news/97/3826/attune-expands-senior-leadership-team.html Thu, 05 Nov 2015 12:07:13 +0530 Attune Technologies, a Singapore-based healthcare technology company that delivers an integrated cloud-based platform for healthcare delivery organizations, has announced the expansion of its leadership team with the appointment of function heads for marketing and projects & implementation. Mr Harish Sivaraman has joined as SVP for Projects & Implementation and Ms Rajlakshmi Raghavan has been appointed as SVP and Head of Marketing. Both these leaders will report into Mr Arvind Kumar, Founder & CEO of Attune. Mr Harish Sivaraman brings with him over 20 years of experience in Healthcare, BPS and IT Services. Prior to joining Attune Technologies, he was part of Medall Healthcare, a leading healthcare diagnostics chain in India, Merrill Technologies and Lason.   Harish comes with expertise in healthcare ecosystem and has driven large BPS companies to scale. Ms Rajlakshmi brings over 18 years of rich experience in sectors such as advertising, direct marketing, event management, PR, corporate communication and consulting. Prior to Attune Technologies, she was associated with Procter & Gamble, McCann Erickson, Ajuba Solutions, Region Holdings and TalentSprint in progressive marketing roles. She has a keen understanding of diverse markets and carries a wealth of experience from early-stage as well as large companies. ]]> https://biospectrumindia.com/news/97/6243/trivitron-to-distribute-sakuras-histopathology-products-in-india.html https://biospectrumindia.com/news/97/6243/trivitron-to-distribute-sakuras-histopathology-products-in-india.html Wed, 04 Nov 2015 12:00:00 +0530 Chennai-headquartered Trivitron healthcare has been assigned as the exclusive distributor for the entire range of Histopathology products from Sakura Japan in India.  Histopathology is the microscopic examination procedure of biological tissues to observe the appearance of diseased cells and tissues in very fine detail. The main use of histopathology is in clinical medicine where it typically involves the examination of a biopsy by a pathologist and interpretation of diseased tissues in microscopic detail. SMART Automation is the logical next step to enhance laboratory workflow optimizing your laboratory's productivity, while reporting better turnaround times using the same resources. Millions of patients around the world have benefited from better and faster diagnoses offered by Histopathology laboratories that have implemented SMART Automation. SMART Automation results in consistent high-quality operations for all the tissue samples minimizing eliminating errors and reduction in rework. Commenting on the alliance, GSK Velu, chairman and managing director of Trivitron Group of companies said, "Trivitron has been in the forefront of bringing the latest medical devices and medical equipment in a most cost effective fashion to India for past 19 years. We are proud to bring to India, the latest in histopathology automation - SMART automation system in association with Sakura Japan. This technology can revolutionize the way a histopathology laboratory functions by reducing the turnaround time and enabling same day reporting."   ]]> https://biospectrumindia.com/news/97/7088/philips-launches-wearable-device-for-psoriasis.html https://biospectrumindia.com/news/97/7088/philips-launches-wearable-device-for-psoriasis.html Mon, 02 Nov 2015 15:32:18 +0530 Philips has marked World Psoriasis Day with the launch of Philips BlueControl 2.0, the second generation of its innovative wearable medical device1 that uses UV-free blue LED light to control symptoms of mild to moderate cases of plaque psoriasis. After its successful launch in the Netherlands, Germany and the UK end of last year, and France earlier this year, the new generation of this clinically tested, medical device has been developed based on user insights and feedback. Philips BlueControl 2.0 is now also available in Denmark, Sweden, and Finland and will be introduced in the coming months to Poland, Belgium, Austria, Switzerland and Hong Kong. New markets like Israel and Italy will follow in the course of 2016. Blue light addresses plaque symptoms by inducing natural processes in the skin. It helps skin to renew itself properly by slowing the accelerated production of skin cells associated with plaque psoriasis. With its anti-inflammatory properties, blue light controls unregulated inflammation and can alleviate the symptoms of affected skin. Philips BlueControl is a gentle, UV-free phototherapy device that gives patients the clinically proven benefits of blue LED light without interrupting their normal daily routines. The visible light induces natural processes in the skin to significantly reduce symptoms such as redness, scaling and thickness. The product has been developed to be easily integrated into a patient's daily routine and reduces the need for physician' visits. Worn simply by adjusting a strap on affected arms, legs, elbows and knees, the UV-free blue LED light therapy is enabled by 40 high-intensity blue LEDs with tailored light settings. Designed with the patient in mind, the battery-driven device can be used anytime and anywhere. This second generation device features the following improvements: a larger treatment area (approx. 25 percent), a more comfortable fixation strap, a thinner device and a longer battery life (lasting for four treatments in a row). Philips conducted two clinical trials in partnership with the University Hospital of Aachen to investigate the efficacy and safety of Philips BlueControl to reduce the symptoms of psoriasis vulgaris. In the second long-term trial, patients were treated for twelve weeks. 84 percent of patients showed an improvement in plaque symptoms (thickness, redness and scaling) compared to the beginning of the trial. In some cases, complete clearance of the plaque was observed. 83 percent of patients rated the usability and comfort of the device as ideal or excellent.   ]]> https://biospectrumindia.com/news/97/7089/ge-healthcare-collaborates-with-navamedic-.html https://biospectrumindia.com/news/97/7089/ge-healthcare-collaborates-with-navamedic-.html Fri, 30 Oct 2015 11:08:00 +0530 Navamedic ASA has announced that Observe Medical Nordic AB, a wholly owned subsidiary of Navamedic ASA, has entered into a development collaboration with GE Healthcare Systems Sverige AB on its newly launched digital urine measurement system Sippi. Sippi, a new standard in digital urine measurement in hospitals, is currently under development for wireless transmission of data into so called Patient Data Management Systems (PDMS). Measuring a patient's urine output is a vital parameter in critical care medicine. With Sippi and a PDMS system, clinics will have the possibility to follow fluid balance online in real time. Once launched, Sippi with wireless data transmission, will be the first commercially available urine measurement device globally with this feature. The ability to automatically record and transfer the critical ill patients urine output data will be further time saving for healthcare personnel and also secure the patient data integrity and accuracy as the risk for human error is eliminated. GE Healthcare is one of the global market leaders in Patient Data Management Systems. Navamedic, via its subsidiary Observe Medical has now entered into a collaboration with GE Healthcare to establish a wireless link from Sippi to Centricity, GE Healthcare's PDMS system. "As a new player in the ICU segment we are very pleased to announce a collaboration with a major PDMS supplier such as GE Healthcare. We will as a first step together with GE Healthcare in Sweden develop a solution for the Nordic countries which is scalable for other markets to come" , said Mr Tom Rönnlund, CEO of Navamedic.   ]]> https://biospectrumindia.com/news/97/6799/siemens-healthcare-introduces-first-twin-robotic-x-ray-system.html https://biospectrumindia.com/news/97/6799/siemens-healthcare-introduces-first-twin-robotic-x-ray-system.html Thu, 29 Oct 2015 15:28:40 +0530 Siemens Healthcare launches the first Twin Robotic X-Ray system, Multitom Rax (Robotic Advanced X-ray) at the University Hospital Erlangen today. Multitom Rax (Robotic Advanced X-ray) enables a wide variety of examinations in a range of clinical areas to be performed using only a single X-ray system for the first time. In addition to conventional 2D X-rays, the system also makes it possible to perform fluoroscopy examinations, angiography applications and even 3D imaging. The operator is always in full control of the system's movement. By the push of a button, both robotic arms are being positioned fully automatically around the patient, improving both safety and convenience. There is no need to move the patient on the system or to change rooms for further imaging procedures, which makes examinations less painful and less time-consuming. Work processes in hospitals can be improved and economic efficiency increased. "We see the Multitom Rax as a universal device that covers all aspects of X-ray diagnostics. You could call it radiology's answer to the Swiss army knife," says Prof. Michael Lell, senior physician at the Imaging Science Institute of the University Hospital Erlangen. The new system can be used in a wide range of applications, from emergency medicine to orthopedics, angiography or fluoroscopy, and can thus help optimize clinical work processes. The fact that the detector can be freely positioned means that quite different X-ray images, both static and dynamic, can be taken in a single room using a single system. That saves time and avoids unnecessary costs, since specially installed modalities for examinations that are not performed on a daily basis can be uneconomical for hospitals. On the other hand, systems that are in regular use can cause lengthy waiting times, and this is where the new X-ray scanner can help ease the burden. Multitom Rax makes work processes economically efficient, while still being able to offer a wide range of examinations. The two ceiling-mounted arms on Multitom Rax can be moved into position automatically using robotic technology, and they can also be moved manually, servo motor supported, when required - to make fine adjustments, for example. While one arm moves the X-ray tube and the large touchscreen, the other carries the 43 x 43 cm flat panel detector, which can record static, dynamic and real 3D sequences. "The robotic technology ensures a new level of precision and automation, enabling a new level of standardization and throughput", explains Mr Francois Nolte, head of the X-ray Products Business Line at Siemens Healthcare. He added, "The precise positioning of the arms in all three planes makes the examinations so much easier: regardless of whether the patient is standing, sitting or lying down, the robotic arms move with perfect accuracy using robotic technology. Our strategy is based on the principle that the system moves, not the patient, which reduces risk of additional injuries and pain."   With conventional radiography systems, the detector often has to be placed in an external holder. In addition to the extra time required, this also involves the challenge of positioning the tube at exactly 90 degrees. Multitom Rax does this at the push of a button for free exams. This also prevents any risk of having to repeat image processes because the tube was not precisely positioned. The system offers optionally also wireless, portable detectors in two different sizes that can be positioned directly between the wheelchair or mattress and the patient's back, which avoids the need to sit the patient up. The automatic control of the robotic arms ensures that they will always take the shortest and safest route to reach the next programmed position. Pre-programmed safety zones and an automatic stop in response to contact also improve safety. 3D computed tomography (CT) images are often used in situations such as orthopedic examinations involving the implantation of prosthetic joints, for example, to ensure that the artificial joint is best adapted to fit the patient's anatomy. Now, for the first time, Multitom Rax makes it possible to take 3D images under the patient's natural weight bearing condition.  3D images can be made of all areas of the body with the patient seated, lying down or standing. Images taken while the patient is standing are essential because for example knees, pelvis and spinal column appear differently under the influence of the patient's body weight compared to when the patient is lying down. As a result, 3D images acquired by Multitom Rax offer better diagnostic and planning certainty compared to those that do not reflect a natural weight bearing condition. Conventional 2D x-rays, for example, do not always reveal fine hairline fractures in the bone. If a bone fracture is suspected, it has previously been necessary to take a 3D image using a CT system to be sure of the diagnosis. With Multitom Rax, however, a 3D image can be taken at the same system, and so the patient does not have to wait for a further appointment or to be transferred to the CT unit. A free-standing patient table and fully mobile system elements with Multitom Rax provide a more comfortable examination atmosphere. The system is designed for all patient types, from children to the elderly, mobile, immobile and adipose individuals. The fact that the table can be adjusted to a very low 50 centimeter table height means that children can get onto it by themselves. It can also be positioned at the most convenient working height. The hospital staff thus has full access to the patient, with no need for the hospital staff to twist into an anatomically unnatural position. The result is an improvement in both safety for the patient and the examining physician, and in the level of convenience, since it is the system that moves when needed, not the individuals. Additional devices and personnel are often essential for interventional procedures such as fluoroscopic needle localization in particular. The open system design makes it possible to position the tube and detector most appropriately in the room. And the fact that both arms are ceiling-mounted means there is no floor-mounted equipment or cable ducts to get in the way. Care (Combined Applications to Reduce Exposure) applications support treatment standardization using Multitom Rax and aim to keep the radiation dose as low as possible for both patients and hospital staff. Removable scatter grids and a copper filter, combined with the sensitive detector, help to minimize dose. Precisely focusing on the area of the body to be X-rayed and avoiding the need to repeat examinations using X-rays helps protect patients from unnecessary exposure to radiation. In the case of fluoroscopy examinations, such as gastrointestinal or swallow exams, several Care features keep the dose low. A preliminary examination using an especially low radiation dose to fine-tune the tube and detector helps to correctly position even in very challenging exams. For all examinations, in addition, the dose used is automatically reviewed and recorded. As a part of the Max system family from Siemens Healthcare, Multitom Rax stands out by providing the same image impression and thus making it easier to compare X-ray images. The controls and user interfaces on the Max systems are identical, which means the operators have no need to familiarize themselves over again with new equipment. The wireless detectors in the Max family can also be used equally with all the systems in the family, improving the level of flexibility. Multitom Rax is also configured to accommodate future trends in treatment with functions that can be adapted at a later time. And lastly, its closed surfaces are easy to keep clean, which contributes to the long service life of the system     ]]> https://biospectrumindia.com/news/97/7537/ge-launches-breast-cancer-awareness-campaign.html https://biospectrumindia.com/news/97/7537/ge-launches-breast-cancer-awareness-campaign.html Thu, 29 Oct 2015 14:11:57 +0530 On the occasion of Breast Cancer awareness month, GE Healthcare reinforces its mission for a healthier India through its latest initiative #SefBE can save a Life! An informative initiative which aims to spread awareness and underline the importance of self-breast examination as the first step towards detecting cancer. The campaign which is interestingly shot, features women from all walks of life sharing a light moment to say 'While a #Selfie can save that special moment, a #SelfBE could go a long way in saving your life'! GE Healthcare collaborated with top oncologists in the country to spread awareness on the growing incidence of breast cancer in the country.   ]]> https://biospectrumindia.com/news/97/7948/neogenomics-to-acquire-clarient-from-ge.html https://biospectrumindia.com/news/97/7948/neogenomics-to-acquire-clarient-from-ge.html Tue, 27 Oct 2015 12:28:51 +0530 NeoGenomics has announced that it has reached an agreement to acquire Clarient and its wholly-owned subsidiary Clarient Diagnostic Services, a provider of comprehensive cancer diagnostic testing to hospitals, physicians and the pharmaceutical industry (together "Clarient"). Clarient, a unit of GE Healthcare's Life Sciences business, is based in Aliso Viejo, California and Houston, Texas and has approximately 415 employees. The acquisition will allow NeoGenomics to broaden its offering of innovative cancer diagnostic tests to hospitals and physicians across the country, and to accelerate its growth in the fast-growing worldwide market for pharmaceutical clinical trials and research. The complementary product offerings and expanded geographical reach of the combined companies are expected to provide customers with substantial benefits and create a significantly larger and more diversified provider of precision oncology diagnostics. Clarient's pathology services and capabilities in the analysis of solid tumor cancers of the breast, colon and lung are highly complementary to NeoGenomics' industry-leading molecular testing services and extensive expertise in testing for hematologic cancers. Hospital, physician, and pharmaceutical industry clients will benefit from the combined company's ability to offer a wider range of world-class tests, closer geographical access to services, and enhanced service capabilities. The acquisition will allow the combined company to further leverage its existing laboratory facilities and infrastructure to drive productivity and lower operating costs. The transaction purchase price includes $80 million in cash, $110 million in Preferred Stock, and 15 million shares of NeoGenomics Common Stock, subject to customary adjustments for working capital at close. The Preferred Stock will be issued at $7.50 per share and is redeemable at the option of NeoGenomics at any time over its ten year term along with any accrued dividends at the original issue price with certain incentives for early redemption. After three years, GE Healthcare will have the option to convert the Preferred Stock and any accrued dividends to NeoGenomics Common Stock at $7.50 per share if the volume weighted average price of NeoGenomics' Common Stock is above $8.00 per share for thirty consecutive trading days. If still outstanding on the tenth anniversary, the Preferred Stock and any accrued dividends will automatically convert into common stock at $7.50 per share. The transaction is subject to approval by the relevant anti-trust authorities and NeoGenomics' shareholders and is anticipated to close in Quarter 4, 2015. On a fully diluted basis, assuming full conversion of the preferred stock, GE Healthcare will beneficially own approximately 32 percent of NeoGenomics. As part of the transaction, the NeoGenomics Board of Directors will be expanded with the appointment of a new director from GE Healthcare. In addition, NeoGenomics and GE Healthcare have agreed to collaborate on a new bioinformatics initiative that combines their shared interest in precision oncology. NeoGenomics' chairman and CEO, Mr Douglas VanOort, said, "Our vision is to become America's premier cancer testing laboratory, and this acquisition is a major step forward in achieving that vision. We have always respected Clarient's outstanding capabilities, and are very pleased to be able to combine them with our own outstanding service offering. Hospital, physician, and pathology clients will benefit from our ability to offer the "best of the best" products and services available from each company. We are particularly pleased to add Clarient's sizable and fast-growing clinical trial support business to further strengthen our own initiatives in this area."   Ms Cindy Collins, CEO of Clarient Diagnostic Services, said, "We're proud of the highly talented and dedicated people at Clarient, who deliver an outstanding level of service to physicians and to leading players in the pharmaceutical industry, helping guide patient treatment and supporting the discovery and development of new medicines. We believe the business will benefit from the focus that will come from being part of NeoGenomics, while allowing GE Healthcare Life Sciences to focus on its core long-term growth areas in bioprocessing, cell therapy and disease imaging."   ]]> https://biospectrumindia.com/news/97/6060/siemens-healthcare-introduces-the-cios-family-of-mobile-c-arms-.html https://biospectrumindia.com/news/97/6060/siemens-healthcare-introduces-the-cios-family-of-mobile-c-arms-.html Tue, 27 Oct 2015 12:28:19 +0530 At the German Congress of Orthopedics and Traumatology in Berlin Siemens introduced a new version of the Cios Alpha and three additional models of the Cios C-arm family. As imaging systems, mobile C-arms play a key role in the areas of orthopedics and traumatology. "Compact design and greater ease of use are common features of the entire C-arm family, as are a standardized user interface and high level of performance. The maximum possible X-ray time, an elevated heat capacity to prevent overheating, and a high current range offered by the X-ray tube all help ensure consistently high image quality during lengthy operations, such as heart surgeries lasting several hours," said Mr Francois Nolte, head business line X-Ray products, summarizing the features of the Cios series. Like the well-established Cios Alpha before it, the new Cios Fusion from Siemens Healthcare features state-of-the-art flat panel detector technology. In total, its field of vision is about 160 percent larger than the standard image intensifier. The Cios Fusion now makes flat panel detector technology available in the medium price segment. This produces an image that is free of geometrical distortion and offers a higher grayscale resolution, making various anatomical structures clearer to see. With two different detector sizes, either 30 cm x 30 cm or 20 cm x 20 cm, this model can be equipped to meet specific requirements. An additional touchscreen that can be located right at the operating table enables the surgeon to control the C-arm from within the sterile work area. The software packages adopted from the Cios Alpha - like the Live Graphical Overlay to mark anatomical structures in contrast-supported examinations, to crop image series elements and play back at different speeds - all help make vascular surgery easier. Cios Connect is the second new C-arm in the Cios family. It covers a very broad area of application in the medium market segment. This highly reliable system offers low service costs and outstanding value for the money throughout its service life. Special software options for vascular imaging with the Cios Connect enable physicians to display individual images simultaneously in subtracted view and in X-ray view, to optimize the presentation of contrast and bone, and to save them directly to the database for documentation purposes. It also offers pulsed X-rays using the subtraction process to ensure better anatomical penetration. This means that vessels can be better represented in cases of stenosis, (vessel constriction), for example. A removable anti-scatter grid also makes it possible to provide pediatric treatment with especially low radiation doses. For lithotripsy - the destruction of kidney stones, for example - the C-arm provides a direct interface to the Siemens Modularis Variostar urology platform, enabling both devices to be operated by a single manual control. Weighing only 248 kilograms, Cios Connect is an extremely light model that guarantees easy handling for OR employees at the operating table.   The third new family member being introduced by Siemens Healthcare is the Cios Select. This is the entry-level model and is intended to serve as a basic product to improve healthcare services worldwide by providing easier access to surgical imaging. It is designed to be especially user-friendly in operation, and its sturdy construction means that the system does not require expensive maintenance. Color-coding facilitates communication during operations. Each direction that the C-arm can be moved is labeled with a color and the brake levers are marked with the same color. Like the entire Cios family, the C-arm uses the image processing algorithm IDEAL (Intelligent Dose Efficiency Algorithm), which ensures high image quality thanks to continuous contrast and brightness adjustments and automatic dose-performance adjustment - guaranteeing the lowest possible radiation dose for treatment. The Cios Select is the only device in its price segment that also offers a subtraction function that makes it possible to remove overlays, like those caused by bones in vascular images. Beginning in January 2016, an expanded version of the Cios Alpha is planned to complement the three new C-arms. It will come with the revised version of the Cios software. A large preview image on the touchscreen makes it easier for OR staff to select the appropriate image settings. A metal correction function compensates for metal components in the image at the push of a button, to enable surrounding tissue to be represented with greater contrast: for example, in the case of major implants. To mark anatomical structures, the Live Graphical Overlay function can now be used in all operating modes regardless of the field of clinical application, and is no longer reserved for users in vascular surgery.   ]]> https://biospectrumindia.com/features/97/8374/hot-start-up-in-silico-approach-to-drug-discovery.html https://biospectrumindia.com/features/97/8374/hot-start-up-in-silico-approach-to-drug-discovery.html Tue, 27 Oct 2015 10:27:55 +0530 He and his wife Ms Sapana Mehendale together founded RASA in 2010, a Bioinformatics and Chemoinformatics start-up offering solutions and services in Life Sciences. The last four years has been very hectic to Mr Sameer and his team. In fact, when they bagged their major project with Wipro, he and his wife, back then, had to work till a day prior to their wedding. "It was quite exciting," recalls Mr Sameer, a professional Bioinformatician. Mr Sameer has a decade of experience in datamining, scientific workflow development, product development and off-shore services and management. Ms Sapana is a pro in software development and Chemoinformatics.   He says that his father-in-law and businessman Mr Ashok Mehendale was the real inspiration behind starting his company. Alongside, Ms Sapna also had a long-time dream of owning a company in the BioIT space. So far the founders have invested Rs 8.5 lakh in the company through soft loans from friends and family. Both the founders bid good-bye to their burgeoning careers with handsome pay packets to build RASA from scratch. "We started our company with a dream to provide BioIT services as well as work more closely on in-silico approach to drug discovery. But soon we realized that most of the life sciences students and professionals lack required skills and always wondered about their careers. So we brought the idea of skill-based training to enhance their profiles," adds Mr Sameer. "At times we were broke financially and morally. But we helped each other building upon our courage and positive hopes." RASA has few products in the pipeline which will be launched by the end of 2015.   RASA plans to open few more branches in other Indian cities including Ahmedabad, Kolkata and Chennai. In the future, it wishes to partner with companies in the US and Europe. "We believe, very soon, we will be able to grab the attention in the Middle-East, Bangladesh, Sri Lanka and a few African countries," reveals Mr Sameer, who loves reading and singing. Mr Sameer feels that a demographic study for a particular business is absolutely essential for a start-up. "Entrepreneur must be able to identify the present and future prospects of the services or products they are going to offer, and also consider competition from the big players," he advices.   In the last 4 years, RASA has done business worth Rs 30-40 lakh per year. It has a target of achieving Rs 1 crore in the next couple of years. Even in the era of internet and social networking, Mr Sameer says that the best visibility for a start-up is through word-of-mouth. "When you provide good and effective services, the clients are surely going to talk about you to others. And the word spreads. This is very effective because the clients have experienced your services and can vouch for it," he points. He suggests that India needs more governing bodies like the BIRAC for encouraging start-ups. "In the field of life sciences, we have very minimum support from the Government. It is extremely difficult to obtain funds from the Government or venture capitalists in this space. India needs to understand the public-private partnership model to the full extent. Investments in life science sector is limited to education. Industrial investment has to be taken as priority and should have separate budgetary allocation. Looking at the broader prospects of life sciences which enriches human life, it is time for the Government to take a note of it. We hope the new Government will be able to attract investments through the 'Make-in-India' initiative," he explains.   Mr Sameer opines that personalized medicine with genomics- and proteomics-based clinical diagnostics, stem cells, BioIT, NGS are the current happening areas in Life Sciences. He states that Pune and Ahmedabad are hot-beds for Life Science start-ups, only next to Bangalore and Hyderabad. "Pune has a better scientific community mainly because of its iconic research institutes. It also provides skilled manpower. The Gujarat government is spending a lot of money in building the infrastructure for biotech. They are supporting new start-ups by providing them with seed funding," he validates. Current Collaborators:  Dr D Y Patil College, Pune Modern College of Pharmacy, Pune Interdisciplinary Science and Technology Research Academy (ISTRA), Pune Sinhgad College of Engineering (SCOE), Pune   5 Entrepreneurial Mistakes To Avoid:  Improper market research  Unspecific services Inadequate funding Random hiring Ignoring IPs 5 Dumb Myths About Life Sciences Start-ups:  There is a dead end No gain after all the hard work Requires huge funds Entrepreneurial Lessons Learnt:    Easier to manage computers than people Credible entrepreneurs attract right talents Staff loyalty increases when shaped up well 4 Killer Strategies For Raising Billion-Dollar Start-ups:  Focused service  Good funding  Qualified and dedicated staff Passion ]]> https://biospectrumindia.com/news/97/4794/novus-biologicals-launches-variety-of-products-for-studying-hypoxia.html https://biospectrumindia.com/news/97/4794/novus-biologicals-launches-variety-of-products-for-studying-hypoxia.html Mon, 26 Oct 2015 13:14:38 +0530 Novus Biologicals has launched a range of products for studying various parameters associated with hypoxia. Hypoxia is a pathological condition that arises due to diminished supply of oxygen to body tissues. Experimental evidence shows that hypoxia plays a major role in the pathology of various diseases including cancer, myocardial and cerebral ischemia, pulmonary hypertension, kidney disease etc. Various studies have shown that a number of proteins are affected during hypoxic conditions. The new products include primary antibodies against various hypoxia targets such as HIF, EGLN etc., as well as hypoxia positive lysates, recombinant proteins and products for RNAi. The wide range of products provided by Novus Biologicals allows user to study different aspects of hypoxia in a variety of applications such as immunohistochemistry, immunofluorescence, western blotting, ELISA and gene silencing. ]]> https://biospectrumindia.com/news/97/6823/bosch-wins-south-asia-ehealth-summit-award-2015.html https://biospectrumindia.com/news/97/6823/bosch-wins-south-asia-ehealth-summit-award-2015.html Mon, 26 Oct 2015 10:03:28 +0530 Robert Bosch Engineering and Business Solutions (RBEI) has bagged the South Asia eHealth Summit Award 2015 in the category of 'Use of ICT in healthcare delivery (mHealth).' The company developed the Maternal And Paediatric mHealth solution and the paediatric feature of which is currently implemented in Apollo Cradle, Kozhikode. The Maternal and Paediatric mHealth app is a robust suite of applications, which provides assistance to young mothers, by taking care of pre-natal, post-natal and pediatric needs. This application could be linked to the hospital's information management system; it can connect seamlessly to the hospital's IT systems and helps making the necessary appointments, tracks progress and provides clinically relevant recommendations. This application thus provides point of care delivery, which is personalized and relevant to the needs of the mother. South Asia eHealth Summit Award is a dedicated platform to explore the latent potential of innovation in health care sector across 8 countries in South Asia: India, Pakistan, Nepal, Afghanistan, Bangladesh, Bhutan, Maldives and Sri Lanka. There were totally 12 nominations that were received which included entries from other countries in South Asia.   ]]> https://biospectrumindia.com/news/97/6825/toshiba-adds-new-product-to-its-x-ray-portfolio.html https://biospectrumindia.com/news/97/6825/toshiba-adds-new-product-to-its-x-ray-portfolio.html Mon, 26 Oct 2015 10:02:38 +0530 Expanding the clinical capabilities of limited R&F room space with the industry's smallest tilting C-arm multipurpose system available, Toshiba America Medical Systems introduces the newest addition to its X-ray portfolio. The Ultimax-i FPD multipurpose system has a small footprint that installs adjacent to back walls to improve patient access and allow for more complex procedures by providing routine angiography lab capabilities within an existing R&F space. Toshiba's Ultimax-i FPD system is designed to efficiently use the space providers have to safely diagnose and treat all patients, without the need for major renovation. The multipurpose system can accommodate up to 500 lb. with a wide, high-capacity table to comfortably image a range of patients. The system features full-spectrum detection on a flat-panel detector with corner-to-corner, 43 cm x 43 cm coverage for high-resolution imaging. This large, flat-panel detector also helps reduce dose by limiting areas of anatomy receiving unnecessarily repeated radiation exposure, and thus results in safer exams. "At Toshiba, we believe hospitals shouldn't have to endure costly construction to renovate smaller existing R&F rooms or delay a system upgrade to expand their imaging capabilities. With Ultimax-i FPD, healthcare providers don't have to sacrifice on advanced imaging technology, allowing them to deliver better patient care and achieve the Triple Aim of reform," said Mr Bill Newsom, director, X-ray Vascular Business Unit, Toshiba. Toshiba will showcase the Ultimax-i FPD multipurpose system at this year's Radiological Society of North America (RSNA) annual meeting in Chicago, November 29-December 24, 2015.   ]]> https://biospectrumindia.com/news/97/7127/is-the-end-in-sight-for-reading-glasses.html https://biospectrumindia.com/news/97/7127/is-the-end-in-sight-for-reading-glasses.html Fri, 23 Oct 2015 11:00:00 +0530 A University of Leeds researcher is developing a new eye lens, made from the same material found in smartphone and TV screens, which could restore long-sightedness in older people. Mr Devesh Mistry, a postgraduate research student in the School of Physics and Astronomy, University of Leeds, is working with liquid crystal to create a truly adjustable artificial lens. As people age, their lenses lose flexibility and elasticity. This leads to a condition known as presbyopia, common in people over 45 years old, and can require optical aids, such as reading glasses. As we get older, the lens in our eye stiffens, when the muscles in the eye contract they can no longer shape the lens to bring close objects into focus. Using liquid crystals, which we probably know better as the material used in the screens of TVs and smartphones, lenses would adjust and focus automatically, depending on the eye muscles' movement. Using these liquid crystal-based materials, Devesh's research is developing synthetic replacements for the diseased lens in the eye - a new generation of lenses and intra-ocular lens implants to rejuvenate sight. Mr Devesh is currently researching and developing the lens in the lab and aims to have a prototype ready by the end of his doctorate in 2018. Within a decade, the research could see the new lens being implanted into eyes in a quick and straightforward surgical procedure under local anaesthetic. Eye surgeons would make an incision in the cornea and use ultrasound to break down the old lens. The liquid crystal lens would then be inserted, restoring clear vision. The lens could also have application in tackling cataracts - the clouding of natural lenses - which affect many people in later life and which can seriously affect vision. A common treatment is to remove and replace the natural lens.   According to Mr Devesh liquid crystals are a very under-rated phase of matter. Everybody's happy with solids, liquids and gases and the phases of matter, but liquid crystals lie between crystalline solids and liquids. They have an ordered structure like a crystal, but they can also flow like a liquid and respond to stimuli. Mr Devesh is working in collaboration with the Eurolens Research at the University of Manchester and with UltraVision CLPL, a specialist contact lenses manufacturer headed up by two University of Leeds alumni. His research builds upon previous work by the same collaborators, who developed a prototype contact lens with an electrically-controllable focus using liquid crystals. The first commercially-available liquid crystal lenses could be on sale between six and ten years' time. The research is funded by the Engineering and Physical Sciences Research Council (EPSRC) and Ultravision CLPL. (Source: School of Physics and Astronomy,University of Leeds research news page)   ]]> https://biospectrumindia.com/news/97/6829/attune-technologies-to-expand-its-business-overseas.html https://biospectrumindia.com/news/97/6829/attune-technologies-to-expand-its-business-overseas.html Wed, 21 Oct 2015 12:43:22 +0530 Attune Technologies, a start-up that makes cloud-based software for hospitals and labs, will tackle markets outside of India after scoring a $10 million Series B round from Qualcomm Ventures and returning investor Norwest Venture Partners. This is the first investment from Qualcomm Ventures' Strategic Venture Fund in India, which was announced at the end of last month. Along with a $6 million Series A that Attune Technologies raised in May from Norwest and angel funding, this brings the startup's total venture funding so far to $17 million. Founder Mr Arvind Kumar said, "There is still plenty of room to grow in India, where Attune's software currently handles 10 million patient records for 2,500 healthcare centers, but it also plans to launch soon in the Middle East, Southeast Asia, and Africa." Attune was founded to give smaller organizations without IT departments an affordable alternative to traditional hospital management software, which is often costly to deploy and maintain. The company charges a fixed monthly fee for SaaS products tailored to hospitals, diagnostics labs, and clinics. "What the cloud and SaaS does is democratize a lot of software which was only available to large hospitals and labs before that could afford to pay a premium," said Mr Kumar. Besides scaling in India, Attune also plans to offer its products in the United Arab Emirates, Qatar, Oman, Saudi Arabia in the Middle East; Nigeria, Kenya, Ghana, and Mauritius in Africa; and Malaysia, India, and Vietnam in Southeast Asia.   Attune's mobile technology may also help it cement partnerships with companies that offer home healthcare visits, a fast-growing market in India.   ]]> https://biospectrumindia.com/features/97/5195/hot-start-up-the-exclusive-scientist-cum-entrepreneur-.html https://biospectrumindia.com/features/97/5195/hot-start-up-the-exclusive-scientist-cum-entrepreneur-.html Tue, 20 Oct 2015 10:31:56 +0530 While brainstorming ideas for his venture, he saw the need for high quality data analysis services - by scientists and for scientists. He recognized it as an opportunity for revenue generation and 'real value addition' to the scientific community. Convinced about the thrust, he started Shodhaka Life Sciences in 2009. He also believed that a long-term goal of achieving better diagnostics will be possible with novel approach for better biomarker identification. Today, he also serves as a core faculty member and scientist at IBAB (Institute of Bioinformatics and Applied Biotechnology), in Bangalore, where Shodhaka is incubated at the institute's business incubator.   He pursued his post-doctoral research at the prestigious Indian Institute of Science (IISc) and at the University of Virginia, USA. Explains Dr Kshitish, "Initially, after my post-doctoral stint at the US, I wanted to be a part of the rapidly growing Indian organizations and contribute to the growth further." Shodhaka is now focusing on providing the much required, high-quality data analysis services and training for scientists, working in different areas in the Life Sciences. "We have been particularly focusing on data from mass scale techniques such as NGS (Next-Generation Sequencing ) and microarrays. But we have also been active in biocuration and biostatistical analysis of smaller scale data in special domains such as health sciences, and as well as custom-designing biological databases and software. "We are the only team, perhaps in the world, that dedicates a huge amount of time and effort in compiling and studying the bioinformatics resources carefully. Our public portal 'startbioinfo.com' will make a huge difference in Life Sciences and to researchers in the field for bioinformatics analysis," he elucidates.   Dr Kshitish managed to self-fund his company. At times, he also sought the help from some of his friends and fellow scientists. This scientist-cum-entrepreneur says that he had no clue about running a business when he started. "I knew nothing about business and have been handling two responsibilities -- as a faculty and an entrepreneur. In addition, poor networking and marketing caused a little setback. But I am glad that the loyalty and personal spread of appreciation by our clients has been helping us so far," he adds. Dr Kshitish voices that the company now is at crossroads. "We could partner with like-minded scientists and expand in phases, or bring in bigger investments. Bigger investments will help us to prioritize on diagnostics and prognostics over the next five years. Otherwise, we would continue offering services in the areas of data analysis, biocuration, development of databases and software. If we get bigger investments, we would like to be the world's leading data analysis service providers," he reveals.   The company intends to reach potential clients from as many countries as possible, but it is not keen on opening other business branches elsewhere. Apart from IBAB, Shodhaka at the moment has collaborations with Vellore Institute of Technology (VIT) and another start-up. It is also hoping to partner with companies in the area of marketing. "We are also looking for investors who understand research-based companies," states Dr Kshitish. The last financial year was quite positive for Shodhaka. "Seeing the positive balance-sheet in the last financial year is a sign that we are finally making business sense too," he exclaims happily. To help internship applicants at IBAB, who otherwise had to travel long distances for written entrance tests, Dr Kshitish started the Shodhaka Online Test System (SOTS).   "This has turned into an accidental product. Many organizations such as IBAB, Centre for Human Genetics (CHG), Karnataka Biotechnology and Information Technology Services (KBITS) and a multinational biotech company have used the system to short list applicants for their courses or jobs. We have now applied a new algorithm and developed a Job-Suitability-Assessment system (SOTS-JSA) that can assist students in career planning, and help recruiters by creating a useful database to screen suitable candidates for specific jobs," he highlights. According to Dr Kshitish, there are two aspects for thriving innovation. "Allowing employees to grow in their area of interests, and focusing on the objectives of projects without bothering too much about money matters," he says. As an entrepreneur, Dr Kshitish is a fan of Infosys founder Mr N R Narayana Murthy Dr Kshitish's other passions include human resource development and management. ]]> https://biospectrumindia.com/news/97/6469/baxter-gets-fda-clearance-for-dialysis-system-.html https://biospectrumindia.com/news/97/6469/baxter-gets-fda-clearance-for-dialysis-system-.html Mon, 19 Oct 2015 12:35:49 +0530 Baxter International has announced that the United States Food and Drug Administration (US FDA) has granted 510(k) clearance for the AMIA automated peritoneal dialysis (APD) system with the SHARESOURCE web-based remote connectivity platform to provide peritoneal dialysis (PD) for the treatment of end-stage renal disease (ESRD). The AMIA APD system is the only device cleared in the United States that incorporates patient-centric features such as voice guidance, a touchscreen control panel and the SHARESOURCE two-way connectivity platform. SHARESOURCE allows physicians to more readily access their home patients' historical treatment data and deliver individual prescriptions remotely. The system also features advanced, animated graphics and automated step-by-step instructions, which were designed to increase the efficiency of home therapy training and administration for ESRD patients in the United States. There are more than 600,000 prevalent cases of individuals living with ESRD in the United States. People living with ESRD require dialysis treatment or a kidney transplant to stay alive. PD therapy is typically managed by patients in their home, at a time of day that is convenient for them. It works by cleaning the blood of toxins and removing extra fluid through the body's peritoneal cavity. The AMIA APD system was developed in collaboration with DEKA Research and Development Corporation (DEKA) to support home PD therapy patients with more intuitive device operation, while providing two-way, web-based remote connectivity with their physicians through Baxter's SHARESOURCE platform. SHARESOURCE also reduces the manual collection of treatment data and organizes records for easy access by healthcare providers. ''Enabling patients to actively work with their healthcare providers to initiate and confidently manage their dialysis therapy is the ultimate goal in the development of AMIA with SHARESOURCE. Baxter's focus is to understand and support access to the best renal replacement options for all patients, and then bring technology like AMIA and SHARESOURCE to healthcare providers so they can help their patients achieve their best possible outcomes," said Dr Bruce Culleton, vice-president, renal therapeutic area lead, Baxter.       ]]> https://biospectrumindia.com/news/97/7572/siemens-introduces-new-pet-ct-system-.html https://biospectrumindia.com/news/97/7572/siemens-introduces-new-pet-ct-system-.html Mon, 19 Oct 2015 12:34:43 +0530 At the 28th Annual Congress of the European Association of Nuclear Medicine (EANM) in Hamburg, Germany, Siemens Healthcare introduces the new Biograph Horizon. The PET/CT (positron emission tomography/computed tomography) system offers premium performance at an attractive total cost of ownership to support clinicians in addressing more clinical indications. This versatility gives users the capabilities needed to serve a broader patient mix and expand into new service lines, without compromising on quality due to budget constraints. It boosts user productivity, providing facilities with more time to plan treatment schedules, personalize studies, serve additional patients and improve workflow efficiency. Additionally, Siemens' recently released Biograph RT Pro edition, a comprehensive PET/CT solution for radiation therapy (RT) treatment planning, provides physicians with high-quality images that drive the development of tailored therapy approaches. Finally, a new software version for Biograph mMR reduces examination times and improves image quality in MR/PET. Biograph Horizon leverages the standard in PET/CT technology to image patients using all commercially available PET tracers, giving users the ability to address more indications in oncology, neurology and cardiology. To help physicians visualize smaller lesions earlier, the system's 4 mm LSO crystals scintillate faster and have a higher light output, providing better image quality and enabling Time-of-Flight.3 With more precise information, physicians can diagnose disease earlier, contributing to more effective care pathways. This can help reduce costs and patient side effects related to ineffective therapies. Biograph Horizon simplifies staff's daily routine by automating manual tasks and offering protocol-based exams to increase productivity. As the smallest PET/CT system with the lowest power requirements, Biograph Horizon minimizes the initial capital investment, while low operating and maintenance costs help manage the total cost of ownership. Additionally, Siemens Guardian Program predicts downtime ahead of time, so maintenance is scheduled when convenient to minimize the impact on system utilization. Automated technologies, such as gentle system warm-up and automatic standby, help extend the economic life of the system as well as help reduce power consumption.   ]]> https://biospectrumindia.com/news/97/6252/healthcare-it-vc-funding-up-in-q3.html https://biospectrumindia.com/news/97/6252/healthcare-it-vc-funding-up-in-q3.html Mon, 19 Oct 2015 12:34:17 +0530 Mercom Capital Group released its report on funding and mergers and acquisitions (M&A) activity for the Healthcare Information Technology (IT) / Digital Health sector for the third quarter of 2015. The report covers deals of all sizes across the globe. Venture capital (VC) funding, including private equity and corporate venture capital, in the Health IT sector increased 32 percent quarter over quarter (QoQ), coming in at $1.6 billion in 148 deals compared to $1.2 billion in 139 deals in Q2 2015; it was also up 66 percent compared to the same quarter of last year. Debt and public market financing in the sector came to $495 million in nine deals including two IPOs. Total corporate funding raised in the sector including VC, Debt and Public Market Financing raised by publicly traded companies and IPOs for Q3 2015 came to $2.1 billion. VC funding has reached nearly $3.57 billion for 2015 year-to-date (YTD), comparable to the $3.53 billion raised during the same period in 2014. "VC funding into Healthcare IT companies bounced back this quarter after a slow start this year. Rating, Booking and Comparison Shopping companies had their best fundraising quarter since we began tracking the category," said Mr Raj Prabhu, CEO and co-founder of Mercom Capital Group. Healthcare practice-centric companies raised $357 million in 42 deals compared to $473 million in 41 deals in Q2 2015. Consumer-centric companies raised $1.2 billion in 106 deals this quarter compared to $727 million in 98 deals in Q2 2015.   The top VC funded category this quarter was Rating, Booking & Comparison Shopping which brought in $728 million in 15 deals. Mobile Health companies were second with $319 million in 59 deals, with mHealth Apps receiving $206 million and Wearables/Sensors receiving $88 million. Personal Health and Wellness companies accounted for $114 million in 17 deals, followed by Practice Management Companies with $72 million in five deals. Telehealth companies raised $65 million in 14 deals and Data Analytics companies raised $61 million in 14 deals. There were 69 early-stage deals at or below $2 million, including 22 Accelerator/Incubator deals. The top VC deals this quarter included the $394 million raised by Guahao, an online health information portal for patients in China to book appointments with physicians; the $130 million raised by ZocDoc, an online doctor appointment booking platform; the $90 million raised by Practo, developer of a physician search engine to book appointments and rate providers, and of practice management software; the $55.4 million raised by Kareo, a provider of cloud-based medical office software for small medical practices; the $55 million raised by Grand Rounds (previously ConsultingMD), a company that matches patients with specialists and connects them for second opinions on a medical diagnosis, and the $50 million raised by Remedy Partners, a developer of bundled payment programs for government payers, health insurers and self-funded employers. A total of 285 investors including six Accelerators/Incubators participated in Healthcare IT deals this quarter, 20 of which participated in multiple rounds. The investors with the highest number of funding deals this quarter included Lux Capital, Rock Health, Sequoia Capital, Tencent Holdings, and Zaffre Investments with three deals each. Fifteen other investors participated in two deals each. Globally, the US companies raised $934 million in 121 deals. Fourteen other countries: Australia, Belgium, Canada, China, Estonia, Finland, Germany, India, Israel, Japan, Malaysia, the Netherlands, Singapore, and the UK recorded deals amounting to $648 million or about 40 percent of the VC funding this quarter, the largest share of funding for companies outside the US since Mercom began tracking the sector.   There were 57 M&A transactions (11 disclosed) in the Health IT sector this quarter compared to 53 transactions (eight disclosed) in Q2 2015. Practice-focused companies accounted for the greatest number of M&A transactions with 39 of the 57, while consumer-centric companies had 18 transactions. Twenty-nine Health Information Management (HIM) companies were acquired this quarter followed by nine Mobile Health (mHealth) companies. Consumer-focused companies have now been involved in 42 M&A transactions this year led by Mobile Health companies with 24.     ]]> https://biospectrumindia.com/news/97/6448/ask-apollo-apollo-offers-virtual-consultancy-service.html https://biospectrumindia.com/news/97/6448/ask-apollo-apollo-offers-virtual-consultancy-service.html Mon, 19 Oct 2015 10:56:00 +0530 Apollo Hospitals has launched new initiative - Ask Apollo, which promises to connect billions of patients to Asia's most advanced healthcare network via video, voice call and email. Health Minister of Karnataka Mr U T Khader inaugurated Ask Apollo in the presence of eminent personalities including Sangita Reddy, Joint Managing Director, Apollo Hospitals Group, Dr Naresh Parmar, CEO of Karnataka Region, Apollo Hospitals, Ron Gutman, Founder and CEO, HealthTap, Guy Ellena, Consultant, Former Director Health and Education, IFC and Dr K. Ganapathy, President, Apollo Telemedicine Networking Foundation. This initiative by Apollo Hospitals is claimed to be an interactive patient-centric service that gives its patients the option to consult a doctor anywhere and anytime at their convenience. Through Ask Apollo, one can also book an appointment, avail instant consultation by a family doctor, diet and nutrition related advice, consultation with a specialist/board of specialists based on the criticality of the ailment. Commenting on the launch, Sangita Reddy, Joint Managing Director, Apollo Hospitals Group, said, "Through Ask Apollo, we continue Apollo Group's legacy of setting industry benchmarks & contributing to elevate the standard of healthcare to the next level. Apollo Hospitals aims at revolutionizing personal technology with the introduction of Ask Apollo where a patient can even select the doctor of their choice and schedule a time they require consultation. Ask Apollo is a 100% virtual service and hence eliminates all hassles of travelling to the clinic or hospital and waiting in long queues." U T Khader said, "We need to take proactive steps in improving the quality healthcare in India. This initiative by Apollo Hospitals is a step to improve accessibility to healthcare and the services of world-class, credible doctors." ]]> https://biospectrumindia.com/news/97/7206/thermo-fisher-introduces-ion-s5-sequencer-in-india.html https://biospectrumindia.com/news/97/7206/thermo-fisher-introduces-ion-s5-sequencer-in-india.html Fri, 16 Oct 2015 16:54:21 +0530 Thermo Fisher Scientific formally unveiled two next-generation sequencing (NGS) systems designed to deliver a comprehensive solution that simplifies targeted sequencing during Genetic Solution Tour India - Bangalore. Built upon the proven capabilities of Ion Torrent technology, the new Ion S5 and Ion S5 XL benchtop systems provide scientists with rapid, cost-effective and flexible platforms that can be scaled for all research areas, including inherited disorders, infectious agents, microbial identification and translational cancer research. Introducing the new product, Dr Gauri Ganpule, associate director - product management at Ion Torrent Business said, "Ion S5, S is for simplicity and scalability. With this platform our customers will be ready to achieve target sequencing in less than 15 minutes of set up time. That is a big step forward when you compare it with ion PGM or proton. It takes less than 45 minutes from DNA to data. This is huge step forward in the sequencing technology. This is not only simple but fast as well. It has the fastest run time, is the fastest benchtop sequencer in the world. This is also an extremely cost effective platform." The Ion S5 and Ion S5 XL systems combine the ability to sequence gene panels and small genomes, as well as exomes, transcriptomes and even custom assays on a single platform. The platforms are designed with 'plug-and-play,' cartridge-based reagents to make setting up and operating the sequencers simple and efficient. With reduced hands-on time and streamlined workflow, the Ion S5 and Ion S5 XL systems make targeted sequencing more accessible to academic, translational and clinical research labs. The new systems require just 15 minutes of manual set up time per sequencing run and less than 45 minutes of hands-on work from DNA to data when using the Ion Chef System for automated Ion AmpliSeq library construction, template preparation and chip loading. The Ion S5 system is ideal for academic or translational labs in need of an all-in-one sequencer without turnaround time constraints, while the Ion S5 XL system is ideal for clinical research labs requiring faster turnaround or higher sample throughput per day. The system features three new Ion chips; the Ion 520, 530 and 540 chips, which offer outputs of 5M to 80M sequencing reads generated in just 2.5 hours. The Ion S5 and Ion S5 XL systems are For Research Use only. Not for use in diagnostic procedures.   ]]> https://biospectrumindia.com/news/97/8313/dr-kiran-mazumdar-on-whats-trending-in-indias-biotech-.html https://biospectrumindia.com/news/97/8313/dr-kiran-mazumdar-on-whats-trending-in-indias-biotech-.html Fri, 16 Oct 2015 16:09:00 +0530 The three-day BIB 2016 is scheduled for February 9-11, 2016, at Hotel Lalit Ashok, in Bangalore. The theme for this most-anticipated upcoming biotech event has been identified as, ''What's Trending in Biotech India'. In her address, Dr Kiran spoke about the happening trends in the biotech space. "BIB 2016 is going to be very exciting and encouraging because of the trends that we are seeing in the biotech. Trends, not just in our country, but worldwide. In India, it is very clear that biotechnology now is a rapidly growing sector. Through the 'Make-in-India' campaign, India is beginning to focus on biopharmaceuticals, vaccines and medical device areas which are becoming trend setters," she pointed. She believes that India will play an important role in biotechnology.   "There are big opportunities in the start-ups space. Bangalore is certainly becoming very-well recognized world over as a start-up hub," added Dr Kiran. Dr Kiran mentioned Genomics as one of the biggest trends in the biotech space. She commented, "Many companies in the Genomics and BioIT space have started gaining traction. They started in and hesitant way. However, they are making big strides today. Given Bangalore's IT prowess, Genomics and BioIT is going to be a big trend setter that we need to be watching out." Dr Kiran named a few companies which are making strides in the Genomics and BioIT space, including, Mapmygenome, Bigtec Labs, Ganit Labs and Genotypic Technology. The second trend she voiced, pointed to the area of biosimilars.   "India is the pharmacy of the world, and it has a large space in generics. We want to emulate this success in biosimilars as well. What we need to do to be successful in the biosimilars sector is ensure that we grow this ecosystem in terms of scientists and clinicians, and everyone needed including engineers, geneticists, and microbiologists, and create a large ecosystem. Both, biomanufacturing and biosimilars, are big opportunities for India," she opined. She also feels that Vaccines can be another big area for India. "India is already playing a leadership role in vaccines, and will continue to forge ahead," she said. Dr Kiran emphasized about India's opportunities in the Ayurveda space. "Ayurveda should open up more in India. We have not leveraged the treasure trove of Ayurveda in this country. We should look at our own knowledge, and that could be a big trend. We must create that trend from India," she encouraged. Moving towards agri-biotech, she stated, "We are the largest producers of Bt Cotton seeds, but haven't gone beyond that. For many years, our efforts in agri-biotech has been thwarted by narrow-minded and unscientific decisions. Agri-biotech is not just about recombinant technology. It is about understanding molecular markers, enhancing productivity, and design hybrids better, with an aim of addressing food security." She shared the importance of creating a trend in sustainable development through biotech.   "Biotech in waste management has big opportunities. Renewable energies is another area where biotech has a huge role to play. Veterinary Sciences also presents exciting opportunities which leverages biotech, thereby enhancing and improving veterinary sector in a new way," she revealed. She further added, "These are not just opportunities to catch-up with the global trends, but to create new trends from our own nation. Dr Kiran also made references to Gene- and Proteomics-based strategies to study diseases and disease markers, as happening trends in biotech. She concluded by saying, "There are lot of opportunities in diagnostics. Every company today is looking at developing companion diagnostics. Precision medicine is another big trend in the world and it depends a lot on diagnostics. These are the trends we need to catch-up with and trends we need to set." Ms V Manjula, IAS, Principal Secretary, Department of IT, BT and S&C, Government of Karnataka, also addressed the delegates. "The Karnataka's biotech policy has been updated from time-to-time. During BIB 2016, we'll further update the policy in tune with the requirements of the sector," she remarked. The Government of Karnataka has come up with a bioventure fund worth Rs 50 crore in collaboration with VC firms. Karnataka will invest Rs 13 crore, and the rest will be open for VCs investments. The Government of Karnataka is also setting up incubation centers for biotech start-ups in partnership with Central Food Technological Research Institute (CFTRI, Mysore), University of Agricultural Sciences (UAS, Dharwad) and University of Veterinary Sciences at Bidar. ]]> https://biospectrumindia.com/news/97/7114/olea-medical-to-join-toshiba-medical-systems-.html https://biospectrumindia.com/news/97/7114/olea-medical-to-join-toshiba-medical-systems-.html Fri, 16 Oct 2015 12:12:00 +0530 Olea Medical SA ("Olea") has announced that the Toshiba Medical Systems Corporation ("Toshiba") and Olea have completed the acquisition of the outstanding shares of Olea, following approval from the French Ministry of Economy. This acquisition enables Toshiba to accelerate the growth of its MRI business and offer new clinical added value to healthcare providers by leveraging Olea's cutting-edge software technology for advanced post-processing and image analysis as well as its broad relationships with the world's key research institutions and customers. "This partnership means we will benefit from both Toshiba and Olea's strengths to accelerate innovation and enhance our global presence", said Mr Toshio Takiguchi, president and CEO of Toshiba Medical Systems Corporation. He added, "Through the integration of both R&D teams we believe we could bring the innovative solutions and products to play an important role in the development of MRI systems." Mr Fayçal Djeridane, president and CEO of Olea Medical said, "This is great news for Olea's customers and our fabulous team, and we are happy and proud to join the Toshiba family. We are convinced this is the right strategy to pursue our commitment to provide a widely accessible, complete package of simple, safe, fast, and accurate tools for full-body image post processing, in order to help doctors improve the diagnosis and follow-up process for patients' benefit worldwide." Toshiba will also be able to provide the multi-modality solutions by integrating Olea's post-processing software with "Vitrea", a widely known enterprise and scanner-connected workstation by Vital Images, another subsidiary of Toshiba, to improve collaboration among experts, consolidate and standardize workflows and enhance diagnostic confidence.       ]]> https://biospectrumindia.com/news/97/6388/ika-introduces-new-product-.html https://biospectrumindia.com/news/97/6388/ika-introduces-new-product-.html Thu, 15 Oct 2015 09:59:18 +0530 The new A 10 basic batch mill from IKA offers a lot of extras for increased safety and ease of use. The mill operates only when the cover is closed and can only be opened when at a standstill. A quick-stop function further increases safety for the operator. A membrane keyboard makes operation easy, while the digital timer, the counter showing the grinding time and the error code display are additional user-friendly features. The mill is unique in allowing users to reduce the capacity of the grinding chamber for small sample sizes. The redesigned batch mill with integrated cooling water connections grinds hard and brittle, as well as soft and fibrous materials - all up to a volume of 50 ml. Samples become brittle in the grinding chamber, which means that tough, oily and aqueous samples can be processed. The A 10 basic can be operated in intermittent mode. The cover is easy to open and close with the bayonet lock, while cutters and knives can be replaced in just a few simple steps. The A 10.1 stainless steel cutter is includedin delivery. The mill can be used in virtually any industry, especially in food, cosmetics and chemicals, as well as in agriculture and pharmaceuticals.   ]]> https://biospectrumindia.com/news/97/6363/fs-honors-attune-technologies.html https://biospectrumindia.com/news/97/6363/fs-honors-attune-technologies.html Wed, 14 Oct 2015 12:18:33 +0530 The six-year-old organization is a healthcare IT product company that delivers an integrated cloud-based system for healthcare delivery organizations. The award was presented to Mr Arvind Kumar, founder and CEO and Dr Anand Gnannaraj, co-founder and chief medical officer at the 7th Annual India Healthcare Excellence Awards 2015 held on October 9, 2015 in Mumbai. Attune Technologies currently offers cloud-based solutions to over 150 hospitals, laboratories, and clinics in India and worldwide and manages more than 8 million patient records on cloud. The platform provides hospitals, labs, and clinics with integrated services like management of patient data, scheduling and billing, and workflow on the cloud. ]]> https://biospectrumindia.com/news/97/6841/ge-healthcare-signs-sales-distribution-agreement-with-c-rad.html https://biospectrumindia.com/news/97/6841/ge-healthcare-signs-sales-distribution-agreement-with-c-rad.html Wed, 14 Oct 2015 11:42:04 +0530 These systems are used for 4D imaging and virtual simulation in radiation therapy. GE will offer these solutions through its price book, making them available to the GE salesforce and their customers worldwide. A special logistic system - C-RAD Smart Logistics- has been developed and is currently being implemented. This system optimizes the logistic processes and simplifies the supply chain for C-RAD's distributors. With its global footprint, C-RAD will therefore be able to launch distribution hubs in Europe, the US and Asia to provide more rapid deliveries. This model could be attractive for other OEM customers in the MedTech industry. It is expected that C-RAD and Cyrpa products will be included in GE's price book during the fourth quarter. First orders are expected during the first quarter of 2016. C-RAD will be ready to deliver from January 2016 on. The worldwide market for advanced CTs sold into radiation therapy is about 400 units a year. The large majority is delivered with a laser system for virtual simulation. In advanced markets the proportion of CTs that is delivered with 4D imaging is rapidly growing. "This new agreement with GE represents an interesting strategic opportunity for us," said Mr Tim Thurn, CEO of C-RAD. He added, "C-RAD has an appealing product portfolio, and it is our intention to make our distributors' product offerings even more attractive. At the same time C-RAD can benefit from the strong presence of the sales and distribution organizations of OEM distributors." ]]> https://biospectrumindia.com/news/97/7598/camtech-introduces-breakthrough-solutions-for-diabetes-epidemic-in-india.html https://biospectrumindia.com/news/97/7598/camtech-introduces-breakthrough-solutions-for-diabetes-epidemic-in-india.html Tue, 13 Oct 2015 17:58:14 +0530 Committed to the concept of 'Make in India' and sourcing local health innovation, the Consortium for Affordable Medical Technologies (CAMTech) at Massachusetts General Hospital Global Health, introduced path-breaking solutions at the CAMTech Diabetes Innovation Hack-a-thon on October 10-11, 2015, at the Indian School of Business (ISB) in Hyderabad. The event brought together over 200 participants, industry mentors and organizers to develop innovative and affordable health technologies that can improve the prevention, diagnosis and management of diabetes in India. The event included keynote speeches from distinguished leaders from the Indian healthcare industry, who challenged participants to focus on specific, diabetes-related problems, such as access to care, affordable treatment and a lack of awareness and education about diabetes. "Lifestyle modification works, but how do we translate this into a community activity, where 72% of India's population lives in rural areas but [most] qualified consultants practice in urban areas?" asked Dr Nadimity Ganapathi Sastry, director, Dr Mohan's Diabetes Specialty Centre. "There is a lack of awareness and there are problems with access to specialized diabetes care facilities. There is an urgent need to implement the '5 A Test' that will make diabetes care in rural India Available, Accessible, Affordable, Appropriate and Acceptable." From early screening and detection tools to gamification aimed at compliance to novel insulin delivery mechanisms, this year's event saw a total of 40 innovations developed over the weekend.   Participants worked around the clock for 48 hours, pitching over 60 diabetes-related healthcare challenges, forming teams, prototyping solutions, and developing business models before presenting their ideas to a panel of judges. The judging panel included the following experts from public health, engineering and business, reflecting CAMTech's cross-sector approach to innovation: • Mr Ganapathy Venugopal, CEO, Axilor• Dr Vijay Panikar, Arogya World• Ms Elizabeth Bailey, Director, CAMTech• Dr Shylaja Srinivasan, Pediatric Endocrine Fellow, Massachusetts General Hospital• Dr Anthony Vipin Das, Ophthalmologist, L V Prasad Eye Institute "It has been so inspiring to see this diabetes initiative unfold into something that can truly change lives in India," said Ms Elizabeth Bailey, director at CAMTech. "The hack-a-thon transformed ideas into winning solutions, and now we want to make sure those innovations are brought to scale in India." This year's event awarded monetary prizes to winning teams in several categories, including:• $1,000 CAMTech Grand Prize: Team Cheeni Kum - a multi-parameter early screening and detection tool to help diagnose diabetic peripheral neuropathy.• $1,000 Marico Innovation Foundation First Place Prize: Team E Stick - a non-invasive device that uses infrared light to measure blood glucose through the earlobe.• $500 CAMTech First Runner-Up: Team Cool Guys - a reliable, reusable, affordable and user-friendly storage case that keeps insulin pens refrigerated through the use of an organic gel.• $250 CAMTech Second Runner-Up: Team Aankhey - a mobile application that helps doctors and paramedics diagnose and raise awareness about diabetic retinopathy.   In addition to monetary prizes, both the winners and participants will receive several post-hack-a-thon opportunities to continue working on their innovations: • Marico Innovation Foundation (MIF), the CSR arm of Marico Limited and Villgro, India's oldest and foremost social enterprise incubator, will provide funding and hands-on mentorship to help teams convert their prototypes into viable, low-cost innovative solutions.• Through sponsorship from Terumo, CAMTech will offer $1,000 to the team that makes the most progress on their innovation 45 days after the hack-a-thon.• Engagement, mentorship and collaboration with local and global experts from health, business and engineering/technology through the CAMTech Online Innovation Platform. "It's been extremely motivating to see the outcomes out of the MIF- CAMTech Hackathon. We are looking forward to identify and support innovative solutions that will positively impact prevention, detection and management of diabetes that will eventually help the underserved population in India," says Mr Harsh Mariwala, founder, Marico Innovation Foundation. ]]> https://biospectrumindia.com/news/97/7593/philips-collaborates-with-aws-to-expand-digital-health-solutions-in-the-cloud-.html https://biospectrumindia.com/news/97/7593/philips-collaborates-with-aws-to-expand-digital-health-solutions-in-the-cloud-.html Tue, 13 Oct 2015 12:04:22 +0530 Royal Philips has announced that it is strengthening its collaboration with Amazon Web Services (AWS) as part of its strategy to enable an ecosystem for new types of connected and personalized digital health solutions. AWS IoT, a new platform that makes it easy for devices to connect to AWS services, will expand the connectivity, capabilities and services of Philips' HealthSuite digital platform, an open IT infrastructure that supports the secure management of data related to a person's health and lifestyle, as well as large scale clinical data. "The digital health revolution and the power of the Internet of Things offer tremendous opportunities to positively transform how care is delivered," said Mr Jeroen Tas, CEO of Philips Healthcare Informatics, Solutions and Services. He added, "By unleashing data from connected devices and health records, combined with analytics, valuable insights into how we can live and age well can be uncovered. At Philips, we seek to empower consumers to be active participants in their own health. For example, by giving them access to and control over their own health information, making that data more actionable, and by facilitating better collaboration between patients, clinicians and caregivers." Philips is collaborating with world-class technology companies such as AWS, academic medical centers, and patient advocates to achieve global scale and accelerate the realization of connected care across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. To drive this new type of care, Philips developed the HealthSuite digital platform, running on AWS. It securely collects, aggregates and analyzes data from a variety of apps and medical devices and systems such as EMRs. This platform has a secure device cloud that is already managing more than seven million connected devices, sensors and mobile apps - fully embracing the potential of the Internet of Things. With AWS IoT, Philips will enhance its platform with a future proof, secure and scalable IoT environment. The technology will create added value for customers in terms of smarter and more personalized solutions for healthier living and care coordination, and allow products - like medical alert systems and baby monitors - to grow smarter over time.       ]]> https://biospectrumindia.com/news/97/6574/omega-diagnostics-inaugurates-manufacturing-facility-in-pune.html https://biospectrumindia.com/news/97/6574/omega-diagnostics-inaugurates-manufacturing-facility-in-pune.html Tue, 13 Oct 2015 11:38:44 +0530 Omega Diagnostics Group, a Scottish based company has inaugurated their first green-field manufacturing facility at the International Biotech Park, MIDC Phase II, Rajiv Gandhi Infotech Park, Hinjewadi, Pune. With an investment of $0.9 million, the company estimates that it could be employing up to 50 people, including high quality positions in production management and technical/ Quality Control roles in the next 12 months. Omega's facility in Pune will initially concentrate on two rapid diagnostic tests (RDT), Visitect CD4 - licensed from the Burnet Institute ("Burnet") in Melbourne, Australia. Visitect CD4 is used for staging and monitoring HIV patients and Visitect Malaria. These high-quality, cost-effective point-of-care diagnostic tests are aimed to improve access, especially for rural patients, and to reduce patient loss to follow-up in India. Speaking on this occasion, Mr Andrew Shepherd, CEO, Omega Diagnostics Group PLC said, "Having been active in India since 1992, and with the Indian healthcare market growing rapidly over recent years, the move to establish a manufacturing base in India is a logical and exciting step forward for Omega Diagnostics Group PLC. Building on the establishment of our sales and marketing office in 2011 we see the potential for major growth, not just in the Indian domestic market but also the opportunity to export products produced in Pune to our global distribution network which covers over 100 countries." Ms Rooma Kr. Bussi, country director Scottish Development International India, also present at the event said, "India is a significant growth market for Scotland, and we see tremendous potential for Scottish companies to achieve product cutsomisation and efficiencies by manufacturing in the country. Healthcare is a priority sector for India and Scottish companies are capable of offering innovative and cost effective solutions most suited to the Indian market. I am delighted with this investment by Omega and keen to see more Scottish companies supporting the PM's investor focussed 'Make in India' campaign. I am sure Scotland and India can collaborate on a much higher scale to boost the overall economic growth of both countries." Omega Diagnostics currently employ 19 people in India including representatives based in the main metropolitan cities. It has a warehouse for distribution of products across India with sub-distributor network of over a 100 distributors offering technical and customer service support to the Indian market.   ]]> https://biospectrumindia.com/news/97/7067/advances-in-genetic-testing-technologies-to-open-up-new-avenues-in-pediatrics-.html https://biospectrumindia.com/news/97/7067/advances-in-genetic-testing-technologies-to-open-up-new-avenues-in-pediatrics-.html Mon, 12 Oct 2015 16:04:44 +0530 The event was attended by a panel of doctors particularly child neurologists and nephrologists. Dr Rajiv Sinha, pediatric nephrologist, said "It is believed that in the coming decade most of the aspects of medical science will be influenced by the rapid developments we are seeing in the field of genetics. The whole genome sequencing has opened up new avenues and genetic testing for various diseases which were previously prohibitively costly is becoming more affordable." Whole genome sequencing generates large chunks of genomics data from a single genome. With powerful bioinformatics tools and algorithms, the data is analyzed and interpreted to generate insights into underlying genetic reasons for human diseases. Dr Braja Roy and Dr Atanu Jana from the AMRI team felt the need of applying genetics in neonatology and opined on the exciting possibilities that this brings in clinical practice. "We are able to conduct whole genome and exome sequencing much faster now with the latest technology platforms," said Mr Sam Santhosh, CEO, MedGenome "This, along with insightful interpretation platforms helps us to meet the turnaround time requirements from clinicians, who are looking to dig deeper into a specific disease condition." ]]> https://biospectrumindia.com/news/97/6830/c-camp-partners-with-the-us-based-qb3.html https://biospectrumindia.com/news/97/6830/c-camp-partners-with-the-us-based-qb3.html Mon, 12 Oct 2015 14:19:40 +0530 Bangalore based Centre for Cellular and Molecular Platforms (C-CAMP), India's premier technology and innovation hub and The California Institute for Quantitative Biosciences (QB3), a San Fransisco Bay-area based non-profit research and technology commercialization institute, have signed a Letter of Intent to create the US-Indo Life Science Sister Innovation Hub in the presence of Prime Minister Mr Narendra Modi when he visited the Bay Area in September. The Innovation hub is aimed at fostering links between both these exciting innovative hubs and enhancing science based entrepreneurship, research, academia and businesses. Through this innovation hub, both the organizations plan to promote collaborations in scientific research, encourage co-development of innovation led products and push these technologies towards commercialization. Innovation-based start-ups will be nurtured and accelerated through incubation and funding opportunities by leveraging the existing entrepreneurial ecosystem in both countries. Commenting on the Partnership, Dr Taslimarif Saiyed, director and COO, C-CAMP said, 'In the last couple of years, C-CAMP has worked extensively to establish a strong life science innovation and entrepreneurship ecosystem in and around Bangalore which nurtures many start-ups all over India with support from DBT and BIRAC. This partnership with QB3 provides an opportunity for C-CAMP to make stronger ties with the San Francisco Bay area cluster - one of the leading innovation ecosystems in the world. We are hopeful of some ground breaking collaborations and outcomes from this partnership in the coming years.' 'C-CAMP and QB3 both appreciate the key role that life science start-ups can play in improving the quality of life for our countries and globally. But C-CAMP and QB3 operate in cultures with different challenges and health care systems. By partnering, we hope to learn from each other,' said Prof. Regis Kelly, director, QB3.   ]]> https://biospectrumindia.com/news/97/6929/frost-sullivan-honors-shimadzu-.html https://biospectrumindia.com/news/97/6929/frost-sullivan-honors-shimadzu-.html Fri, 09 Oct 2015 11:29:15 +0530 Shimadzu, a global leader in providing analytical solutions, scientific equipment, testing machines, balances and medical equipment, has received the 2015 Frost & Sullivan Asia Pacific Mass Spectrometry (MS) Company of the Year award. The award was bestowed on the Asia Pacific subsidiary of Kyoto-based Shimadzu Corporation, which is celebrating its 140th Anniversary this year. Interestingly, Shimadzu's Koichi Tanaka is also the only person in the world to have won a Nobel Prize in Chemistry for pioneering MS analyses of biological macromolecules in 2002. Shimadzu (Asia Pacific) operates across 18 countries in APAC, ventured into providing MS technology to its customers in the year 2010. It has since emerged strongly as one of the most sought after MS leader in the region. Two key factors were evaluated while deciding on the Company of the Year Award - 'Visionary Innovation and Performance' and 'Customer Impact'. While Visionary Innovation and Performance included criteria like Addressing Unmet Needs, Visionary Scenarios Through Mega Trends, Implementation Best Practices, Blue Ocean Strategy and Financial Performance; Customer Impact considered criteria like Price/Performance Value, Customer Purchase Experience, Customer Ownership Experience, Customer Service Experience and Brand Equity. Ms Rhenu Bhuller, partner and senior vice-president, Asia Pacific Healthcare Practice, Frost & Sullivan, said, "Since 2010 when Shimadzu launched its first triple quadropole mass, the company has continued to push the boundaries in providing advanced solutions. The company's expansive analytical range of high-speed technologies that provide high sensitivity performance as well as excellent data quality enables improvements in analytical throughput and expands the potential range of applications. Keeping the end user in mind, it's user-friendly interfaces also provide for good customer experience leading to more productive analytical workflow. As the requirements of qualitation for applications requiring high sensitivity and speed in the Asia Pacific region grow, Shimadzu's solutions are well placed to meet the needs of the industries within the region." Mr Kiminobu Imura, managing director of the Shimadzu (Asia Pacific) said, "It is a very big honor for us to receive the prestigious 2015 Frost & Sullivan APAC Mass Spectrometry Company of the Year award. I would like to congratulate everyone at Shimadzu (Asia Pacific) for their dedication in working towards the company philosophy of "Contributing to Society through Science and Technology". The recognition by Frost & Sullivan reiterates our commitment towards our customers in line with our company's slogan. 'Excellence in Science' is not just our motto but is a way of life for us at Shimadzu. This award proves that our efforts are certainly helping to make the world a better place."         ]]> https://biospectrumindia.com/news/97/6923/medtronic-launches-new-product-for-lung-cancer.html https://biospectrumindia.com/news/97/6923/medtronic-launches-new-product-for-lung-cancer.html Fri, 09 Oct 2015 11:28:06 +0530 Medtronic unveiled a next-generation version of its superDimension navigation system software. The superDimension navigation system enables a minimally invasive approach to access difficult-to-reach areas of the lung, and can aid in the diagnosis of lung diseases. Using the patient's CT scan, the superDimension planning software generates a 3D virtual bronchial tree and allows physicians to map pathways to reach pulmonary targets during the electromagnetic navigation bronchoscopy procedures (also known as ENB procedures). During a workshop session at the 2015 European Respiratory Society (ERS) Annual Congress a global perspective on lung cancer approach was outlined. It was supported by opinions from both an interventional pulmonologist and a thoracic surgeon. All attendees had the opportunity to experience and test the advanced platform and its extended capabilities. "This minimally invasive device helps physicians prepare for the most appropriate therapy depending on the stage of the cancer. Improving chances to more easily identify patients at an early stage may bring a dramatic change in the societal impact of lung cancer," said Ms Bronwyn Brophy, vice-president early technologies EMEA, Medtronic. "These advanced tools and technologies demonstrate Medtronic's commitment to expanding the specialized lung health products available to pulmonologists and thoracic surgeons. The continuum of care is the healthcare journey a patient takes from diagnosis to recovery. Our goal, across this continuum, is to diagnose earlier, intervene earlier, treat better and help patients recover faster," said Mr Chuck Brynelsen, president early technologies, Medtronic.   ]]> https://biospectrumindia.com/news/97/6994/illumina-introduces-genomics-solutions-to-advance-clinical-research-.html https://biospectrumindia.com/news/97/6994/illumina-introduces-genomics-solutions-to-advance-clinical-research-.html Thu, 08 Oct 2015 11:08:23 +0530 Illumina has announced the launch of new TruSeq library preparation kits and Infinium arrays that enable researchers to explore genetic variation on a more comprehensive scale. The new additions to the application-driven portfolio address a broad range of genetic studies from whole exome to population and disease specific genotyping, leveraging the Illumina industry-leading portfolio of genomic analysis systems. Illumina will highlight these new genomic solutions at the 2015 American Society of Human Genetics (ASHG) meeting on October 6 - 10. "These solutions are designed to meet the needs of researchers exploring diverse populations and diseases, enabling them to cost-effectively navigate a wide continuum of study types ranging from broad discovery to routine analysis," said Mr Francis deSouza, president of Illumina. The following new products are intended for use with Illumina next-generation sequencing (NGS) systems and are complemented by new data analysis applications available on Illumina's BaseSpace cloud computing platform. TruSeq Enrichment Portfolio (TruSeq Exome and TruSeq Rapid Exome Library Prep Kits) One of the most widely used targeted sequencing methods is exome sequencing, allowing efficient identification of coding variants across a broad range of studies in cancer research, Mendelian disease and population genetics. The TruSeq Exome kit is based on a shearing protocol, and the TruSeq Rapid Exome kit is based on an enzyme-mediated (transposase) protocol. The kits are compatible with a variety of sample types, including formalin-fixed, paraffin-embedded (FFPE) samples, and offer automation compatible, seamless workflows from sample to variant calling. TruSeq Custom Amplicon Low Input Designed and optimized for use with FFPE samples, this new product consistently delivers robust performance at 10ng of DNA input. Additional features include a simplified, scalable workflow protocol and 16-sample starter kit. Concurrently, Illumina is releasing an updated version of DesignStudio, its online custom assay design tool. Expert design assistance and full assay optimization support is also available through Illumina Concierge. The following new products are intended for use with Illumina's iScan and HiScan microarray platform. As with TruSeq Custom Amplicon, these products can also be customized utilizing DesignStudio or Illumina Concierge. Infinium DrugDev Consortium Array Effective drug development depends on thorough target validation and the comprehensive understanding of drug safety and efficacy as early as possible in the development process. Developed in collaboration with leaders in translational genomics and computational biology, the DrugDev Consortium Array enables researchers to perform genetic studies leveraging the principle of Mendelian randomization to reproduce key elements of a randomized trial. Key applications include drug target discovery and validation, drug repurposing and drug specificity studies.   Infinium MethylationEPIC BeadChip is the next-generation of the HumanMethylation450 BeadChip kit and leverages new genetic content generated as a result of the National Institutes of Health (NIH) sponsored ENCODE (Encyclopedia of DNA Elements) research program. The new microarray provides unparalleled coverage of CpG islands, GENCODE genes, ENCODE open chromatin, ENCODE transcription factor binding sites and FANTOM5 enhancers. Infinium HD technology enables content selection independent of bias often associated with alternative methylated DNA capture methods. The new microarray is also compatible with FFPE samples, offers a streamlined workflow and achieves 98 percent reproducibility for technical replicates. Infinium ImmunoArray-24 v2.0 BeadChip is a new addition to Illumina's genotyping array portfolio and is designed to detect genetic variation in the human immune system. Applications include the research and analysis of novel and causal variants associated with major autoimmune and inflammatory disorders. Infinium Multi Ethnic Array Family provides a cost-effective, high throughput approach for large scale population research across diverse human populations. These new arrays leverage expertly developed content from groups such as the Consortium on Asthma among African-ancestry Populations in Americas (CAAPPA), Population Architecture using Genomics and Epidemiology (PAGE), and T2D-Genes, as well as large scale studies such as the 1,000 Genomes Project and clinical reference databases such as Online Mendelian Inheritance in Man, and ClinVar. Delivering excellent genomic coverage and high value content at an affordable price, the Multi-Ethnic Array Family provides customers with the power and pricing to effectively carry out studies across the world's populations. Also at ASHG, Illumina will announce an Illumina Accelerator Sequencing Grant competition available to applicants for the incoming Illumina Accelerator genomic startup class.   ]]> https://biospectrumindia.com/news/97/7727/fda-clearance-for-hitachis-ct-system.html https://biospectrumindia.com/news/97/7727/fda-clearance-for-hitachis-ct-system.html Thu, 08 Oct 2015 10:36:16 +0530 Hitachi Medical Systems America has announced FDA clearance to market its Supria 16-slice CT system. The new Supria 16 features a compact design and provides Smart-Dose compliant (XR-29) lower dose patient safety capabilities. Supria 16 combines the latest dose saving technologies in a compact design with enhanced patient access features to comfortably accommodate a wide range of patient sizes, including bariatric patients. Supria 16 can be sited in a scan room as small as 200 sq. ft. "Supria demonstrates Hitachi's continuing commitment to provide superior product value by combining the latest imaging technologies in a design that while compact, still affords the premium patient accommodation features of more expensive systems including a 75cm gantry aperture, standard 1.8 meter scannable range table with 500 lb. weight capacity," said Mr Mark Silverman, director of CT Marketing. "The Supria provides a strong value-based solution for CT providers needing to replace older higher-dose ≤16-slice CT Systems with a new lower-dose Smart Dose compliant (XR-29) system. The dose reduction features included standard with Supria actually surpass the XR-29 Standard," said Mr Sheldon Schaffer, VP and general manager MR/CT.     ]]> https://biospectrumindia.com/news/97/3507/voice-for-bt-2015.html https://biospectrumindia.com/news/97/3507/voice-for-bt-2015.html Wed, 07 Oct 2015 14:20:22 +0530 Since its inception in 2012, the event has been conducted every year in various regions, in India, to provide a platform for Biotechnology students to exhibit their knowledge. The 'voice for BT' program, this year, was held in Shanmugha Arts, Science, Technology and Research Academy (SASTRA) University in Thanjavur, Tamil Nadu, in which undergraduate biotech students from 30 science and engineering colleges participated. The design of the program is such that the top 2 winners from each region gets to participate in the grand finale, scheduled to be conducted in Bangalore. Students expressed their views on various topics including, 'application of agricultural biotechnology in improving food nutrition in crops'; 'the importance of cleaner environment and the role of biotech tools' and 'the importance of waste to energy and the role of 'biotechnology'. India is said to be the 3rd biggest biotech industry in the Asia-Pacific region.   Biotechnology as a subject has grown rapidly and as far as employment is concerned, it has become one of the fastest growing sectors, said Novozymes India in a statement. The employment record shows that biotechnology has a great scope in future, Novozymes India added. The winner of the 'voice for BT' contest was bagged by Mr Sriram K from Rajalakshmi Engineering College. The runners-up were Mr M Venkatesh from Garden City College of Science & Management; and Ms Sneha V from Jain University School of Graduate Studies. The panel of judges included Mr Divakar Rao, advisor, Life sciences sector; Mr Mads Bjornvad, head, R&D, Novozymes India; Dr Rajeev Soni, senior manager, R&D, Novozymes, India; and Dr Moses Christopher, head, application development, Novozymes, India. The winners were awarded with cash prizes and internships at Novozymes R&D facility in Bangalore. ]]> https://biospectrumindia.com/news/97/7012/philips-appoints-chief-medical-officer.html https://biospectrumindia.com/news/97/7012/philips-appoints-chief-medical-officer.html Tue, 06 Oct 2015 17:08:32 +0530 Royal Philips has announced the appointment of Dr Jan Kimpen as the company's Chief Medical Officer, effective January 1, 2016. This function will play an increasingly important role in supporting the company's strategic focus on the HealthTech market and Dr Kimpen will add a wealth of related experience to Philips' senior management team. Dr Kimpen, MD, PhD, professor, joins Philips from the University Medical Center Utrecht (UMC Utrecht) in the Netherlands, where he was Chairman of the Executive Board. He will report to Philips CEO Mr Frans van Houten. "I am delighted that Jan Kimpen is joining us from UMC Utrecht, which is a highly renowned and innovative hospital in the Netherlands," said Mr Frans van Houten. He added, "The healthcare industry is undergoing a huge transformation, and Philips' integrated approach to coordinated care across the health continuum is our answer to addressing the industry's dual challenge of delivering better patient outcomes at lower costs. Integrated solutions are at the core of our strategy and in his role as Chief Medical Officer, Jan Kimpen will work closely with our global network of medical thought leaders to ensure that deep clinical insights and a people-focused approach are at the heart of our propositions." Dr Jan Kimpen (Belgian, 1958) joined UMC Utrecht, one of the largest healthcare organizations in the Netherlands, in 1997 and became President of the Board in 2009. At UMC Utrecht, Dr Kimpen strengthened ties with the world-renowned Netherlands Cancer Institute at the Antoni van Leeuwenhoek Hospital (NKI-AVL) and the Netherlands Pediatric Oncology Center. He has been the driving force behind partnerships with Philips and Eindhoven University of Technology, where he is a member of the strategic advisory board Health. "I very much look forward to joining Philips," said Dr Kimpen. He added, "Given the healthcare industry's complexities and interdependencies, it is my firm belief that innovation in health care cannot be achieved in isolation and that collaboration is therefore key to success. My experience in forging partnerships in the public healthcare sector will provide a strong foundation to expand and deepen Philips' cooperation agreements with the numerous public and private stakeholders in the healthcare industry."     ]]> https://biospectrumindia.com/news/97/7830/roche-launches-the-new-cobas-c-513-analyzer.html https://biospectrumindia.com/news/97/7830/roche-launches-the-new-cobas-c-513-analyzer.html Tue, 06 Oct 2015 14:35:31 +0530 Roche has announced that its new, dedicated high-throughput HbA1c testing solution, the cobas c 513 analyzer, is now available for countries accepting the CE mark. "The increasing number of people with diabetes is challenging healthcare providers and is putting a significant strain on healthcare systems. With the cobas c 513, Roche is meeting the dedicated and growing testing needs of our customers," said Mr Roland Diggelmann, COO, Roche Diagnostics. With the new cobas c 513 analyzer, Roche is replacing its existing dedicated HbA1c analyzer, the COBAS INTEGRA 800 CTS, which has been a successful and well-established solution. The cobas c 513 analyzer further increases laboratory efficiency by doubling the already market-leading throughput of the INTEGRA 800 CTS from 200 to 400 patient results per hour. The cobas c 513 achieves this performance with the same footprint. The cobas c 513 features direct results reporting, thereby minimizing the risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. This saves valuable time and laboratory resources while ensuring high quality of results. Furthermore, the cobas c 513 analyzer provides a higher on-board test capacity. Enabling laboratories to load the analyzer with more tests at a time saves laboratory space, releases lab resources and ensures a smooth workflow. The new analyzer also offers closed tube sampling, which reduces hands-on time, prevents sample contamination and ensures operator safety for laboratory personnel.       ]]> https://biospectrumindia.com/news/97/7942/mhra-signs-mou-with-cdsco.html https://biospectrumindia.com/news/97/7942/mhra-signs-mou-with-cdsco.html Tue, 06 Oct 2015 11:55:15 +0530 The Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MOU) with Central Drugs Standard Control Organisation (CDSCO) in India. This agreement will increase collaboration between the two countries in the area of medicines and medical devices with the aim of further improving public safety in the two countries. This is the first MOU agreed with CDSCO, part of the Ministry of Health and Family Welfare of Republic of India and was signed by Dr Gyanendra Nath Singh, India's Drugs Controller General, and MHRA chairman, Professor Sir Michael Rawlins. It provides a formal agreement between the two organizations, and strengthens relations between the UK and Indian governments. The central understandings of the agreement include promotion of each other's regulatory frameworks, requirements and processes. Significant outcomes will include the facilitation and exchange of information and opportunities for technical cooperation of mutual benefit, helping to ensure the regulators are better equipped to protect the health of their respective publics. MHRA chairman, Professor Sir Michael Rawlins said,"We are committed to protecting the health of UK citizens and that's why we are continuing to formalize our collaborative efforts with key partners like India.We operate in a global environment and agreements such as these serve to further strengthen our ability to promote good practices and we look forward to working even closer with our Indian counterparts." Dr Gyanendra Nath Singh said,"The MoU signed between MHRA and CDSCO is going to create a new platform where patients will be given utmost importance. Quality medicine, affordability and transparency will be the tools for making medicines available to the people of the two nations."   In 2014, MHRA carried out more than 550 inspections in the UK and 125 in non-EU countries, 49 of which were in India. The India Brand Equity Foundation states that the Indian pharma sector accounts for about 2.4 percent of the global pharma industry and is the third largest in terms of volume. Approximately 25 percent of UK medicines are made in India and each batch is tested on importation to ensure it is safe, of good quality and effective and it is important that MHRA assessors continue to inspect Indian sites to ensure Good Manufacturing Practice - a globally recognised regulatory framework. Sir Michael Rawlins added, "It's essential that the commitment to good quality manufacturing comes right down from the top levels of management to those on the factory floor, and throughout the entire industry. Indian firms already accept and understand this, and the MOU is part of a concerted effort to ensure the UK and wider global public continue to have access to quality and safe medicines." The signing of the MOU took place at CDSCO's headquarters in New Delhi and was followed by a series of meetings to discuss next steps.     ]]> https://biospectrumindia.com/news/97/6871/some-facts-about-internet-of-things-in-india.html https://biospectrumindia.com/news/97/6871/some-facts-about-internet-of-things-in-india.html Mon, 05 Oct 2015 12:20:00 +0530 The Indian Government's plans to develop 100 smart cities in the country, for which Rs 7,060 crore has been allocated in the current budget. The Union Govt has also announced a draft IoT policy. The government of India has launched the Digital India Program aimed at transforming India into a digitally empowered and knowledge economy. There is a huge push for setting up digital infrastructure, creating smart cities across the country and using IoT to create solutions for problems faced in manufacturing, agriculture, energy, health and other industries. Also, as per reports earlier this year, the government is planning offering incentives to VC-funded start-ups, which work on Internet of Things technologies, to further boost its 'Make in India' programme. April 9 is celebrated as Internet of Things Day (IoTDay). Bangalore Alpha Labs (BAL) and IoT Bangalore (IoTBLR) launched the city's very first IoT Lab on the occasion of IoTDay last year. The Indus Entrepreneurs (TiE) has signed a MoU with IESA (India Electronics & Semiconductor Association) to promote start-ups and entrepreneurs in fabless semiconductor and electronic products in the IoT or connected devices space. ]]> https://biospectrumindia.com/features/97/6863/transforming-healthcare-through-iot.html https://biospectrumindia.com/features/97/6863/transforming-healthcare-through-iot.html Mon, 05 Oct 2015 12:02:00 +0530 According to a latest report from International Data Corporation (IDC), the worldwide Internet of Things (IoT) market will grow from $655.8 billion in 2014 to $1.7 trillion in 2020 with a compound annual growth rate (CAGR) of 16.9 percent. This technology offers a lot of prospects across different industries. "The healthcare sector is a fast growing IoT market with a host of new tools and technologies. It is expected to improve the quality and efficiency of various healthcare services, but at reduced costs," said Dr Prasant Misra, Senior MTS (Member Technical Staff), Robert Bosch Centre for Cyber Physical Systems, (RBCCPS). Here's a look on how it can do that. Read on... IoT for Healthcare The visible and most widespread application of IoT seems to be in the wearable devices, but there are other numerous uses of this technology in the healthcare sector. IoT can transform healthcare through connecting various equipment, communication systems and software applications that help monitor patient health in real-time. Apart from Remote health monitoring, it can also be of utmost help in assisting elderly in smart homes. Proactive health monitoring by care givers is another application of IoT says Mr Vinay Nathan, CEO and Co-Founder Altizon Systems, a Pune-based IoT start-up. He added, "Today healthcare equipment providers can monitor their equipment across the globe and diagnose device and patient health through embedded sensors. This goes a long way in increasing detecting anomalies and improving quality of life and health outcomes for patients."   Mr Nathan further highlights another important aspect, revolutionizing surgical procedures. He added, "Multiple channels of data from equipment is integrated and routed wirelessly. All the vital data pertaining to the surgery flows to the operating team, the control room as well as to remote observers. This data is used to setup alerting mechanisms, remote consultation during operating procedures and many other applications." The technology also has a widespread applicability for pharmaceutical companies in maintaining clean rooms. "Pharma Companies' need to maintain an absolute clean room without manual intervention at places where certain drugs are kept or getting manufactured. Monitoring of air quality, ambience temperature and pollutant levels through sensors and alerts based on any violations help them the pharma companies, maintain quality levels," said Ms Shalini Kapoor, Chief Architect-Internet of Things Cloud, IBM Analytics, IBM India. Monitoring effectiveness and downtime of IoT-enabled medical devices is another area which is of extreme important in healthcare sector. Ms Kapoor continued, "Imagine a scenario where manufacturer of a medical infusion pump can charge hospitals based on the no. of patients that infusion pump serves. This is possible only if the medical infusion pump is instrumented and is sending data to IoT cloud where it is being analyzed." Transforming Healthcare through IoT: Present scenario The healthcare sector is slowly embracing this new technology. With new technology advancements, healthcare and treatment is becoming cheaper and more accessible. "With IoT, it will be easier to monitor patients 24/7. There are numerous start-ups, who are focusing on developing IoT products and technologies in the healthcare domain. All this started recently and is expected to fly high with significant potential," said Mr M.N. Vidyashankar, President, India Electronics & Semiconductor Association (IESA). The companies are leveraging the power of IoT to provide patient care. Mr Nathan added, "With the usage of mobile devices, wearables and electronic records healthcare providers have access to information in real time which improves the health care provision. With IoT it is easier to collect and integrate data from these devices resulting in quick and better services." Hospital management is another area where this technology is of great help. Mr Nathan enlightened, "Implementing IoT solutions for managing equipment using cloud technology gives real time usage data of the equipment. This equips hospitals to optimally utilize its equipment for providing adequate care when required."He further added, "IoT is providing with the intelligence to capture and analyze data that was not impossible earlier. This data is giving insights into previously incurable conditions and also facilitating high end and personalized services." IoT in Manufacturing Market research reports predicts that close to 50 billion devices will be connected by the year 2020. Everybody want a piece of this space. Investors and tech companies are ramping up the IoT space to leverage the opportunities it presents. "Electronics hardware play a major role in the revenue generation for IoT industry. With this huge scope we see in developing the Hardware side, there also lies a huge opportunity for IoT in the manufacturing side," said Mr Vidyashankar. Mr Nathan adds, "Major equipment manufacturing companies are creating smart connected products that leverage IoT to provide value added services to its customers. These equipment have inbuilt sensors that track and transmit data, which opens up the possibilities of using this data for running analytics on it and building innumerable applications." However, the manufacturing industry does not seem to be in sync with this new trend. "The onus is on hardware manufacturing companies to understand the scope and need for getting equipment connected. Also, the Indian manufacturing industry is not completely aware of the business value of the data that can be captured from equipment and the right to ownership of data," said Mr Nathan. Challenges/Roadblocks IoT holds great potential for industries and society. However, this potential can be realized only by overcoming the challenges being faced by the industry. Lack of common platform being one. Mr Nathan highlights further, "Existence of multiple platforms and protocols with no common standards make integration of different systems a big challenge. The standards vary based on the industry vertical, kind of devices involved, security concerns and used cases. There is a pressing need for standardization across devices and platforms in order to makes things IoT ready. The industry needs to agree upon and establish common standards for connectivity, discovery and device authentication." Robust connectivity is another pressing issue faced in the Indian context. Mr Nathan further adds, the basic requirement for IoT is to connect things starting tiny sensors to remotely located machines. There has to be a major push towards creating the infrastructure for IoT to scale. Dr Misra points out another major roadblock. "The primal problem with IoT solutions is the lack of interoperability at various levels, and more predominately at the device (or 'Things') level. 'Things' or physical modules/ platforms contain the interface to the physical world for measurement of various physical parameters. Due to interoperability constraints, the existing IoT ecosystem does not have provisions for interfacing devices of varying heterogeneity and complexity from multiple manufacturers that use different proprietary middleware technologies," he said. Recommendations/ Push for the prosperity Reports suggests that the market size for IoT in India will be $10-12 billion by 2020. "This figure can be much higher if proactive steps are taken right now," said Dr Misra. "R&D should be encouraged. Start-ups in the IoT sector still lack an ecosystem like in China or Silicon Valley whether it is easy access to quality facilities for development/prototyping or funding," said Mr Abhishek Latthe, CEO, SenseGiz, an IoT start-up He added that the Tax breaks to start-ups can be helpful as IoT needs high initial investment before a company can start generating sufficient revenues. Dr Misra suggests the solution for interoperability highlighted in the previous section. He proposed, "The most effective solution to this problem is the creation of the plug-n-play infrastructure across platforms from multiple vendors, necessary for interoperability and successful deployment of large-scale city wide systems." He added, "It should abstracts the features, capabilities and controls of the sensors and communication layer to allow higher level services to be developed and interacts with sensors/networks in a generalized manner. This should further be backed up with appropriate policies and standardization efforts. The information governance challenges are also significant in the areas of: Interoperability, Data integrity, Access control, Data quality, Security and compliance." Future Forecast Though IoT is not a new technology, it is certainly an evolving one and presents a lot of opportunities in various sectors. "IoT in critical verticals such as transport, wellness, healthcare, home, agriculture, livestock, water supply networks etc, has the power to transform the country at the grassroots level," said Mr Vidyashankar."Going forward, we will see a lot of tailor-made IOT solutions uniquely for India as well as adoption of the IoT products and solutions from the developed countries," said Mr Latthe. This technology in the coming years will be a boon for both industries and consumers alike believes Ms Kapoor, "IoT, Cloud and Analytics coming together will create powerful scenarios which will help consumers and businesses."Start-ups are already showing the way for innovators, and large industry players and academic institutes are teaming up. "A range of business models are emerging, along with scalability solutions for hardware products, and global and local applications of IoT platforms," added Mr Vidyashankar. "Overall these are exciting times for the IoT space and at Altizon we are very bullish on this being the one area, India can emerge as a technology power house," concluded Mr Nathan. The future looks promising for the IoT industry. ]]> https://biospectrumindia.com/news/97/6843/medtronic-completes-acquisition-of-twelve.html https://biospectrumindia.com/news/97/6843/medtronic-completes-acquisition-of-twelve.html Mon, 05 Oct 2015 11:34:54 +0530 Medtronic has announced that it has completed the acquisition of Twelve, a privately-held medical device company based in Redwood City, CA, focused on the development of a transcatheter mitral valve replacement (TMVR) device. "This acquisition supports Medtronic's therapy innovation strategy, as TMVR represents an important growth opportunity for our business. We look forward to welcoming the Twelve team to Medtronic to help deliver an exciting and differentiated therapy to patients," said Mr Sean Salmon, senior vice president and president, coronary and structural heart, Medtronic. The Medtronic TMVR technology is not available for sale in any country.     ]]> https://biospectrumindia.com/news/97/6853/former-abbott-executive-to-lead-siemens-healthcares-north-america-business.html https://biospectrumindia.com/news/97/6853/former-abbott-executive-to-lead-siemens-healthcares-north-america-business.html Mon, 05 Oct 2015 11:34:17 +0530 Siemens Healthcare has appointed Mr David Pacitti as president of Siemens Medical Solutions USA and Head of Siemens Healthcare's North America Regional Organization, effective October 19. Mr Pacitti succeeds Dr Gregory Sorensen, who served as president and CEO of Siemens Healthcare North America from 2011- 2015. Mr Pacitti will be responsible for leading the marketing, sales, service, and support functions for Siemens Healthcare in the US with additional oversight of Canada, across the entire Healthcare portfolio including medical imaging, laboratory diagnostics, therapy solutions, and services. He will be based at the US headquarters. "Mr David Pacitti's leadership experience at Abbott and his deep healthcare industry experience will greatly benefit Siemens as we look to strengthen our vision for the Healthcare business. I am honored to welcome him to Siemens Healthcare," said Dr Bernd Montag, Global CEO of Siemens Healthcare. Mr Pacitti comes to Siemens Healthcare from Abbott Vascular where he served as senior VP of the US Commercial, Sales, Marketing and Operations from 2013-2015. In this position, and as a member of the Senior Executive Staff, he ran Abbott Vascular's business in North America. Prior to this, Mr Pacitti was VP of Abbott's Commercial Operations from 2009-2013. He joined Abbott Vascular after spending 14 years at Guidant Corporation.     ]]> https://biospectrumindia.com/news/97/8373/ms-annie-hai-yuan-lo-joins-quintiles-board-of-directors.html https://biospectrumindia.com/news/97/8373/ms-annie-hai-yuan-lo-joins-quintiles-board-of-directors.html Sat, 03 Oct 2015 10:00:00 +0530 Quintiles Transnational Holdings has announced that Ms Annie Hai-yuan Lo, has been appointed to its Board of Directors, effective immediately. Ms Lo will also serve as a member of the Audit Committee of the Board. Ms Lo has more than 30 years of financial and operational experience at Johnson & Johnson, a global healthcare company, most recently serving as the Chief Financial Officer of the Worldwide Consumer & Personal Care Group from 2001 until her retirement in 2011. Ms Lo serves as a director of Ansell Ltd., an Australian manufacturing company, and TransForce, a Montreal-based transportation and logistics company. Ms Lo received her Bachelor's Degree in Taiwan from National Taiwan University and her Masters of Business Administration from Eastern Michigan University. She is a Certified Management Accountant.   ]]> https://biospectrumindia.com/news/97/7520/waters-partners-honors-ohio-state-university-laboratory.html https://biospectrumindia.com/news/97/7520/waters-partners-honors-ohio-state-university-laboratory.html Fri, 02 Oct 2015 10:00:00 +0530 At a ceremony at The Ohio State University, Waters Corporation officially welcomed the University's Campus Chemical Instrument Center into the Waters Centers of Innovation Program. Headed by Prof. Vicki Wysocki, an Ohio Eminent Scholar and Professor of Chemistry and Biochemistry, the Center is widely renowned for fundamental research into ways of characterizing protein complexes, or assemblies of multiple individual proteins, that living organisms depend on for their survival. Ultimately, the research of the Wysocki Research Group could one day lead to new understanding of conditions, such as high blood pressure, arteriosclerosis, pre-eclampsia, and chronic obstructive pulmonary disease, among others. "We are honored to join the Waters Centers of Innovation Program as a partner and applaud the state-of-the-art instrumentation and technical support that Waters has provided. Having access to the Waters technology has enabled the stellar work of Dr Wysocki as she works to develop improved mass spectrometry approaches to determine structures of protein complexes. This research is helping researchers across the Ohio State campus and elsewhere to achieve breakthroughs and develop solutions that will have global impact," said Ms Caroline Whitacre, vice-president for Research at Ohio State. Mr Eric Fotheringham, director, Waters Centers of Innovation Program said, "Vicki is an exemplary scientist and a highly-respected member of the worldwide mass spectrometry community. She is certainly deserving of this recognition and we are proud to have her participate in our program." In recognition of Prof. Wysocki, Waters sponsored a symposium on September 22,2015 titled Mass Spectrometry in Structural Biology on the campus of The Ohio State University.       ]]> https://biospectrumindia.com/news/97/5896/fujifilm-sonosite-introduces-new-educational-experience-for-customers-.html https://biospectrumindia.com/news/97/5896/fujifilm-sonosite-introduces-new-educational-experience-for-customers-.html Fri, 02 Oct 2015 09:30:00 +0530 FUJIFILM SonoSite announces the introduction of a new educational website designed specifically to enhance education in point-of-care ultrasound. "FUJIFILM SonoSite has always been committed to physician education and we are now expanding with a new global digital resource for customers. The online institute allows our customers to have quick and easy access to information, we're making it easier for them to gain knowledge through a one stop service. Many physicians around the world have limited access to point-of-care ultrasound resources and we aim to close that gap. We believe physician education leads to better patient care which is our ultimate goal," said Dr Diku Mandavia, chief medical officer and senior vice-president, FUJIFILM SonoSite. Following is a summary of offerings: •Modules: Each module provides an overview of a point-of-care ultrasound application, from select references to more comprehensive presentations and videos. •Webinars: Each expert-led webinar will focus on best practices and the most commonly performed procedures and techniques. Visitors are able to register for upcoming webinars or view a recording of a past webinar. •Events and Workshops: Throughout the year, FUJIFILM SonoSite will host and participate in events and workshops around the world. Visitors are now able to browse events by date, specialty and country. •Toolkit: Access to a portfolio of downloadable materials that communicate the benefits of point-of-care ultrasound. Resources include Addressing Central Line Complications, Improving Efficiency Across the Hospital and The Safety Impact of Point-of-Care Ultrasound among other educational booklets. •eLibrary: Holds educational resources including 3D learning videos, pathology videos and images, and articles of significant interest related to point-of-care ultrasound. •Reimbursement Guidance: With the constant changing state of reimbursement coverage and payment information for diagnostic and ultrasound-guided procedures, FUJIFILM SonoSite recognizes the importance of accurate coding and billing and provides a number of guidance documents.     ]]> https://biospectrumindia.com/features/97/7810/hot-start-up-shaping-the-indian-clinical-genomics-landscape.html https://biospectrumindia.com/features/97/7810/hot-start-up-shaping-the-indian-clinical-genomics-landscape.html Thu, 01 Oct 2015 14:59:29 +0530 "I have read a lot of blogs, articles and books on entrepreneurship but nothing prepares you for the journey. It is seductive. It is addictive. It is painful. It grinds you. It shocks you, and it saps you of all your energy. Yet, you go to bed wanting to be back at the first light of the day," wrote Mr Kumar Sankaran recently, the founder and CEO of Leucine Rich Bio, in his company's blog, recounting his entrepreneurial journey in the last one year. The Terrific Trio The start-up focuses on human genome data interpretation, especially for clinical and research use, and developing cutting-edge novel solutions for drug discovery. Mr Prabhath Manjappa joined Mr Sankaran as the co-founder and COO during its inception. Says Mr Sankaran, "Both of us have years of experience in systems biology. We have been discussing genomics and the latest new trends happening in NGS for a long time. We analyzed the markets, and spoke to a variety of experts in the field, figuring out what was exactly needed."   Dr Debojyoti Dhar, who holds a PhD from the Indian Institute of Science (IISc), is another member in the dynamic team, who serves as the company's director, and oversees the business development and innovational aspects. Flagship Technologies The company has developed two different technologies - AGIS and LRB-HGVD. AGIS, stands for Advanced Genome Interpretation Suite, is a flagship clinical data analysis platform for analyzing and interpreting clinically relevant sequence information from human genomes. It uses powerful algorithms to report precise disease causing mutations, says Leucine.   "This platform is for hospitals and sequencing centers around the world," adds Mr Sankaran. The Human Genome Variation Database, also known as LRB-HGVD, is Leucine's in-house database, curated and maintained by it. The database is said to provide functional information, mutation impact on disease, drug response, and variant impact on protein structure and functions. Nascent Market The company now employees 11 members including the trio.   "Overcoming our fears and investing our own money was our first biggest challenge," recalls Mr Sankaran. "But it forced us to innovate in every areas -- from finding our office space to recruiting the right people." He feels that the company's mammoth challenge now is the nascent Clinical Genomics market in India. "Our platform is for international clients. At present the clinical genomics space in India is evolving. Competing at the international level without sufficient back-up will be a battle," reveals Mr Sankaran. He adds that there is a lot happening in the US and Middle-East in the area of Clinical Genomics. "Clinical genomics is a happening area. A lot of people around the world are talking about it. There are numerous conferences happening worldwide. We have the US President Obama and other eminent leaders talking about precision medicine and personalized medicine through genomics. That's a good sign," he explains.   Minimal Awareness Co-founder Mr Manjappa comments that investors' awareness about the industry is very minimal. "It's not a classical industry. It's a new technology which needs to mature. Investors expect a lot of business angle. Venture capitalists look at the market numbers. Since it is a new technology, we don't have clear market numbers at the moment. They'd straight away ask for market size when presented with ideas," he states. Client Base Leucine's clients now are mainly researchers from both academia and research hospitals.   "We are trying to get in more hospitals. We would like to cater to as many of them as possible around the world," Mr Sankaran says. Its key clients include Institute for Stem Cell Biology and Regenerative Medicine (inStem), IISc, Alexandria University (Egypt), Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), and Translational Health Science and Technology Institute (THSTI). Partnerships Five years from now, Leucine envisions to be a company which is a part of genome diagnostic interpretation. "We also want to partner with pharmaceutical and drug discovery companies in clinical genomics. We are also looking forward to partner with institutions, and help in identification of rare diseases or orphan diseases which hardly gets noticed in India. We want to firmly establish clinical genomics in India, and help spread its awareness. We want to contribute to rare diseases, either through internal research or through our products and services," notes Mr Manjappa.   He feels that social media can be leveraged in building a start-up's brand and business. In fact, Leucine's first client actually came through the micro blogging social site, Twitter. "Through social media we get to know what is happening in and around the world. Promotion of your business in LinkedIn is equally important," Mr Sankaran points. Leucine is open for alliance partnering for distributing and promoting its products in other countries like Australia, Europe, Middle East, South East Asia and the Americas. It has partnered with Delhi-based distributor, NextGen Life Sciences, to distribute its products and services in India. "We would like to partner with BIRAC at some point in time, as we have an in house R&D focus on a Malaria project," shares Mr Sankaran. Recently, Leucine also partnered with German-based Diadome, where both the parties will promote each other in the field of medical diagnostics. Mentorship Mr Sankaran adds that some of the incubators are located in the outskirts of the city. "We can't afford so much of travel time and money. There are pros and cons in joining incubators. They are helpful in building start-ups but getting there every day is a lot of trouble. During the initial few months it doesn't matter where you work from. You don't need an air-conditioned office or something grand," he opines. He sees a lot of Indian start-ups cropping up in Pune and Delhi. "Being located close to institutions like IITs or IISc will be an added advantage for receiving good amount of mentorship," he observes. Crowdfunding Opportunities Mr Sankaran comments that in the West, there is more awareness on funding availability. He suggests, "In the West, people need not go in search of funds. In India, more awareness needs to be created about start-up funding opportunities. At the moment, in our country, more investments are happening only in the e-commerce space." He states that the Government needs to have more initiatives towards building good start-ups. "The government doesn't seem to communicate well. They need to advertise the funding opportunities through websites and other media, and ensure there are proper screening procedures for start-ups, and reach the right people at the right time," he opines. He also says that start-ups in India can try the crowdfunding strategy. "Many start-ups have enjoyed success through crowdfunding, but it is still new in India," he remarks. Selling Ideas The founder also emphasizes that if one cannot sell their start-up idea to family members or friends, then it would be a hard ride trying to sell it to customers. "If you do not believe in your start-up, then no-one else will. One cannot keep excusing saying they don't have enough money to start. If you can't sell your idea to your own uncle, then this is going to be very difficult to sell to someone else. In biotechnology, we need more angel investors than venture capitalists. They should be patient and willing to invest, and wait for a few years for the fruits," he highlights. He also speaks about start-up myths that are widely held in Life Sciences. He adds, "People believe that there are no significant amount of ROI, which is not true. For life sciences start-ups, you need not have plenty of initial capital. One does not have to have full-fledged labs right at the beginning. There are enough funds and backing up support from the government." Market Needs For entrepreneurs who are starting up, he advises not to go after too many domains. "Concentrate on what the market needs and wants. You need to come up with innovations that are capable of solving market problems. The more projects you do, the better you become at it. Just go out and talk to people and communicate about your product or the company, and try to sell your products and services. Get some people to use your products. Most of us wait till we have the perfect product to sell. A lot of entrepreneurs try to be marginally better than what is already available in the market. However, their aim should be to make products that are 10 times better than what's available in the market," he elaborates. The Magical P's In the entrepreneurial journey, patience and perseverance are the keys, he admits. "It is not going to happen overnight. It is going to be a long journey and a lot of struggle. Keep innovating. Innovation is the key. And that's the only way you can face the competition better. It is not good to start as a single entrepreneur. Finding a co-founder is important where both can help each other," he suggests. The entrepreneur involves himself in small start-up groups in the city and enthusiastically listens to similar stories from other start-ups. "It's a good way to beat the stress, and you feel that you are not alone in the entrepreneurial journey," he ends. ]]> https://biospectrumindia.com/news/97/7707/siemens-healthcare-joins-cancer-id-.html https://biospectrumindia.com/news/97/7707/siemens-healthcare-joins-cancer-id-.html Thu, 01 Oct 2015 12:40:55 +0530 Siemens Healthcare has joined the CANCER-ID consortium, an initiative of the European Union's Innovative Medicines Initiative (IMI), to explore the potential of blood-based biomarkers to revolutionize the detection and treatment of cancer. This consortium currently includes 33 partners from 13 countries working together to establish standard protocols for the clinical validation of blood-based biomarkers. These biomarkers, including circulating tumor cells (CTCs), are potential indicators for the tumor burden of patients living with cancer, especially for patients for whom biopsies of the tumor are not available. Blood-based tests (also known as "Liquid Biopsies") that could detect and track CTCs would offer the convenience of a simple blood test that allows doctors to reliably monitor a patient's condition. The information provided by these simple tests may improve the range and efficacy of treatment options from which physicians and their patients could choose. "By participating in and contributing to this consortium, we believe we can more quickly expand our knowledge of biology of biomarkers like CTCs. This will accelerate the development of innovative technologies and assays for clinical applications to detect cancer, identify the best treatment options for patients with these life-threatening diseases, and determine the effectiveness of their care," said Mr Trevor Hawkins, senior vice-president Siemens Clinical Laboratory. CANCER-ID brings together experts from academic and clinical research, innovative Small-to-Medium sized Enterprises (SMEs), diagnostic companies such as Siemens Healthcare Diagnostics, and the pharmaceutical industry to establish the clinical utility of liquid biopsies for the detection and treatment of cancer. "Blood-based analysis of tumor derived cells and nucleic acids offer a novel concept of liquid biopsies which can provide real-time information relevant to cancer diagnosis and therapy," said Prof. Klaus Pantel, head of the Department of Tumor Biology at the University Medical Center Hamburg-Eppendorf and one of the academic leads for the consortium. He added, "The CANCER-ID project fills the substantial gap between basic research focused on novel methods for the detection and characterization of circulating tumor cells and nucleic acids and the development of robust validated assays required to bring the liquid biopsy concept into the clinic."   The Innovative Medicines Initiative is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI program, IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU's research and innovation program, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects 'in kind', for example by donating their researchers' time or providing access to research facilities or resources.   ]]> https://biospectrumindia.com/news/97/5545/healthcare-it-market-growing-at-13-4-cagr-to-2020-.html https://biospectrumindia.com/news/97/5545/healthcare-it-market-growing-at-13-4-cagr-to-2020-.html Wed, 30 Sep 2015 11:48:08 +0530 The healthcare industry is undergoing a major transformation due to the challenge of providing more cost-effective personalized care. The push towards predictable outcomes and higher quality of care is leading to convergence of information technologies. Healthcare IT systems are emerging as powerful tools to create and maintain electronic health records (EHRs) for maintaining the workflows in the entire healthcare organization. Majority of the demand for healthcare IT solutions is driven by the growing need to reduce healthcare costs while adhering to the regulatory requirements set by government organizations for ensuring safety, security, and confidentiality of patient information. The growing adoption of health information exchanges (HIEs) and EHR systems and improved quality of care and clinical outcomes are some other factors driving growth of the global healthcare IT market. In addition to the demand for information technology solutions from healthcare providers, the growing need of healthcare insurance providers to efficiently manage an in-depth record of claims and reimbursements is also expected to contribute to the growth of the global healthcare IT market during the forecast years. Developed geographies like North America and Europe are likely to grow at a lower CAGR as compared to the Asia-Pacific market, which is expected to grow at the highest CAGR of 15.4 percent during the forecast period. Growth in the Asia-Pacific region is largely driven by the increasing government initiatives for eHealth, rising medical tourism, and growing demand for quality healthcare in this region. In addition, factors such as increasing per capita incomes in emerging countries such as China and India are driving the growth of the Asia-Pacific healthcare IT market. Segment-wise, the healthcare providers segment is poised to reach $157 billion by 2020, growing at a CAGR of 16.4 percent during the forecast period. The healthcare provider solutions segment is further segmented into clinical solutions and non-clinical solutions. The clinical solutions segment is expected to grow at the highest CAGR of 19.8 percent during the forecast period, owing to the increasing demand for improved patient safety and patient care, stringent regulations regarding healthcare provider solutions, and the need for integrated healthcare systems.       ]]> https://biospectrumindia.com/news/97/6743/medtronic-acquires-lazarus-effect.html https://biospectrumindia.com/news/97/6743/medtronic-acquires-lazarus-effect.html Wed, 30 Sep 2015 10:53:30 +0530 Medtronic has announced that it has acquired Lazarus Effect, a California-based and privately-held medical device company focused on acute ischemic stroke products that facilitate the capture and removal of clots. The acquisition is another example of the company's commitment to its key growth strategy of therapy innovation. The Lazarus Effect acquisition by Medtronic is an all-cash transaction of $100 million at closing. "With this acquisition, Medtronic reinforces its commitment to providing innovative solutions to clinicians and patients fighting stroke," said Mr Brett Wall, president of the Neurovascular division, which is part of the Restorative Therapies Group at Medtronic. He added, "Lazarus Effect's 'mesh cover' technology complements our ischemic stroke portfolio, and further enhances our Neurovascular business's ability to deliver next generation technologies." The Lazarus Cover device is an innovative differentiating technology that is complementary to Medtronic's Solitaire stent retriever platform. This technology is designed to address clinical needs with a novel nitinol "mesh cover" that folds over a stent retriever device during clot retrieval and "candy wraps" the stent with the clot inside. "Medtronic has been a significant supporter of the recent clinical work showing improved outcomes of ischemic stroke patients treated with endovascular therapy. Their support of data driven clinical evidence and the success with their Solitaire stent retriever device make them the clear market leader for treating ischemic stroke. Lazarus Effect is pleased to bring our innovative technologies together with Medtronic's market leading therapies. look forward to working closely with Medtronic to bring this next generation platform forward to the benefit of future patients," said Mr Martin Dieck, co-founder, president and CEO, Lazarus Effect. The Lazarus Cover evice is an adjunctive device used in stent retriever procedures and obtained CE Mark authorization in November 2014 for commercial distribution in the European Union; the US regulatory approval process is pending.   The transaction is expected to meet Medtronic's long-term financial metrics for acquisitions. Medtronic expects the net impact from this transaction to be earnings neutral in fiscal year 2016 as the company intends to offset any dilutive impact of the transaction. Medtronic will report the Lazarus Effect product line as part of its Neurovascular division within the Restorative Therapies Group.     ]]> https://biospectrumindia.com/news/97/6432/reverse-innovation-can-address-affordability.html https://biospectrumindia.com/news/97/6432/reverse-innovation-can-address-affordability.html Tue, 29 Sep 2015 14:39:57 +0530 The keynote address was delivered by Dr Diego Olego, senior VP, Philips technology and R&D management; and Mr Vishal Bali, co-founder and chairman, Medwell Ventures. Mr Bali pointed that healthcare needs has to be on the national agenda. "It is important to put healthcare sector right in the forefront. It is the need for advances in healthcare for the citizens and the nation. Budget-after-budget we have the same conversation about India spending 1 percent of its GDP for healthcare. Eighty percent of India still pays healthcare costs out of pocket. The moment you make healthcare a national agenda, that is when you create more opportunities to deliver healthcare to the last mile." Today, 76 percent of all Fortune 500 companies in the world are in the healthcare business. There are 7,500 healthcare start-ups across the globe, having the biggest forces of disruption in the global healthcare industry.   In the last one year alone, there were about 95 M&As in the medtech space totaling to a value of $20 billion, and the Indian healthcare start-ups has raised $108 million in venture capital funding. Mr Bali also commented that reverse innovation can create affordable healthcare solutions. "Reverse innovation can create maximum innovations with affordable solutions in digital technologies. We are a country of scarce healthcare resources. There is a huge ecosystem in India which is working towards creating affordability. We need to stop thinking in terms of infrastructure and start thinking about services, technologies, and platforms, and convergence of these services and technologies. The phone is the new gateway to the healthcare globally. Affordability cannot come at the cost of quality and precision. Today we see a lot of technology mobility which has not happened in the past." Early diagnosis and discharge of patients at the right time from hospitals are seen as key elements that contribute to healthcare costs. Dr Diego Olego spoke in terms of how companies can go about innovating, and the framework in which they innovate to address the global challenges because of finite resources.   "Billions of people lack access to basic healthcare. Innovation will play an important role here. We are thinking along the health continuum, and we need to look at the continuum holistically to tackle the challenges. Firstly, we need to innovate keeping in mind how it will affect the continuum of healthcare. Secondly, we got to innovate solutions that will attack and solve challenges end-to-end. Lastly, it is about innovating at the intersections. Innovation is no longer an idea which starts in a garage. It has to be placed in an ecosystem and worked together with other stakeholders in the healthcare delivery system," Dr Olego said. Dr Olego believes that data will play a significant role in healthcare. "One of the major challenges we have today is that data is completely fragmented. We need to address the issue of making data flow seamlessly. From our perspective, data becomes crucial towards healthcare delivery across continuum of care," he added. Currently, India has shortage of supplies in healthcare including hospitals, physicians, technologies and paramedical forces. It lacks 6,000 beds in the country according to WHO. "This is not going to fill overnight. We are a country where healthcare is a fastest growing sector. On one hand we have shortages in the healthcare ecosystem, and on the other, we have the greatest opportunities, witnessed by the rapid growth of healthcare in India," Mr Bali remarked.   In the chronic diseases segment, India is amongst the highest in the world. "We are 1.3 billion people and India has a genetic proposition for chronic diseases. We have to start rebuilding healthcare in a new dimension using digital technologies to create an entire opportunity of accessibility and higher affordability, which is what the future healthcare is going to be about," opined Mr Bali. He highlighted that it is time to rethink healthcare for India and not just in terms of infrastructure. "We have dealt with infrastructure for a long time. Healthcare infrastructure creation is getting difficult day-by-day. We need to start looking at healthcare challenges to create better ways in filling the gap. Challenges of affordability and accessibility is there in every country. Our per capita spend on healthcare is less than $100 a year for the vast Indian population," he held. The huge disruptions happening in the healthcare start-ups ecosystem are the forces of change, where, companies are using mobile technologies which answers the challenges, Mr Bali noted. "This is one of the biggest opportunities," he mentioned, "where India can use the great power of connectivity between healthcare and technology providers, and provide better platforms for healthcare delivery in the country. It is time for us to think differently of new models."   In 2014, there were 103 FDA-approved healthcare apps in the market. "Is this going to be an app-led healthcare world? The answer is a 'yes'. These apps meet the gold standard of precision, innovation, and safety, and are now going to be prescribed by clinicians. It is beginning to rule us, and we need to wake up to the reality," Mr Bali stated. "This is a powerful time in our present and future. Never before we have seen so much disruptions happening at the same time." Mr Bali concluded by saying, "It is important to innovate knowing the market opportunities behind the innovation, and try to scale up so that the market opportunities are realized. It is about meeting an unmet need, and the scale of that opportunity, and identifying a market that will go and absorb it." ]]> https://biospectrumindia.com/news/97/6177/strides-plans-to-raise-rs-1500-crore-.html https://biospectrumindia.com/news/97/6177/strides-plans-to-raise-rs-1500-crore-.html Tue, 29 Sep 2015 11:24:39 +0530 In a BSE filing, Strides Arcolab said, "The Board of Directors of the Company have approved the proposal to raise long term funds by way of issue of GDRs/ ADRs/ FCCBs/ QIP or such other equity linked instruments as may be permissible for an amount upto Rs 1,500 crore including a green shoe option." The fund raising is subject to shareholders' approval and such other statutory approvals as may be required including that of Foreign Investment Promotion Board, the company added.   ]]> https://biospectrumindia.com/news/97/5763/russian-firm-semiotik-eyes-indian-market.html https://biospectrumindia.com/news/97/5763/russian-firm-semiotik-eyes-indian-market.html Mon, 28 Sep 2015 12:19:49 +0530 Semiotik, portfolio company of Biofund RVC, made an agreement with Yashraj Biotechnology,a Mumbai-based company, for the supply of research microchip on the base of carbohydrates (glycochip) for assay of glycan-binding proteins. Glycochip Semiotik is a thin slide containing a library of polysaccharides (glycans). It is possible to attach up to 600 glycans to the chip and diagnose about a hundred diseases with its help. In particular, the chip can be used for diagnostics on infectious, autoimmunity and oncological diseases. The study performed by the specialists of Yashraj Biotechnology using glycochip Semiotik containing up to 400 glycans demonstrated that two of seven studied antibodies bound specifically carbohydrate ligands. These data opens the prospect of targeted bioengineering of new antibodies both for diagnostics and therapy of malignant neoplasms. The concept of this unique microchip was designed and developed in Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences by the team of the Laboratory of Carbohydrates in collaboration with New York University, which helps in clinical trials, certification and licensing of the microchip for the markets of Russia, CIS and USA. At present microchips Semiotik are used by several groups from Russia, Switzerland, Spain, Bulgaria and USA.   "At the example of cooperation with Yashraj Biotechnology. we can see the demand for the glycochip platform developed by Semiotik for solution of complex reaserch tasks of the search of diagnostic biomarkers not only in Russia but also abroad," said Mr Egor Beketov, general director of Biofund RVC.     ]]> https://biospectrumindia.com/features/97/8094/home-healthcare-market-worth-349-8-bn-by-2020.html https://biospectrumindia.com/features/97/8094/home-healthcare-market-worth-349-8-bn-by-2020.html Thu, 24 Sep 2015 16:22:00 +0530 According to a new market research report by MarketsandMarkets, the global Home Healthcare Market is expected to reach $ 349.8 billion by 2020 from $ 227.5 billion in 2015, at a CAGR of 9.0% during the forecast period. The growth of this market is mainly driven by factors such as rising geriatric population across the globe, growing need of cost-effective healthcare delivery due to increasing healthcare costs, rising incidences of chronic diseases, and technological advancements in devices. However, changing reimbursement policies, limited insurance coverage and risks to personal safety of home care workers are the factors restraining the growth of this market to a certain extent. The report segments the Home Healthcare Market based on products, services, software, telehealth, and region. Based on products, the market is segmented into testing, screening and monitoring products; therapeutic products; and mobility care products.   The testing, screening, and monitoring products segment is expected to account for the largest share of the home healthcare market, by product, in 2015. The rising emphasis on preventive medicine is expected to boost the growth of the home healthcare testing, monitoring, and screening devices market. The potential to reduce healthcare complications and ensure the portability of devices with high accuracy is expected to create a significant demand for monitoring and testing devices. Moreover, with the rising number of patients suffering from chronic diseases in many countries across the globe, the demand for these products is increasing. The telehealth market is poised to grow at the highest CAGR during the forecast period, owing to the increasing adoption and utilization of telecommunication in providing care.   In 2015, North America is expected to dominate the market, followed by Europe. The converging trends of aging population, technological advancements, and favorable reimbursement policies are driving the Home Healthcare Market in North America. However, Asia is poised to be the fastest-growing region during the forecast period. Factors such as rising geriatric population, increasing adoption of innovative techniques, increasing disposable income levels, expansion of home healthcare companies in this region, rising awareness about home healthcare, and increasing need for affordable healthcare delivery systems will drive the growth of the Asian market. ]]> https://biospectrumindia.com/news/97/6722/ge-healthcare-create-new-business-unit-shs.html https://biospectrumindia.com/news/97/6722/ge-healthcare-create-new-business-unit-shs.html Thu, 24 Sep 2015 12:47:09 +0530 GE Healthcare has announced the creation of a new business unit, Sustainable Healthcare Solutions (SHS), that will develop high-value, low-cost technologies and healthcare delivery solutions across multiple care settings. The new organization will invest $300 million as part of a multi-phase effort to develop a more robust affordable healthcare portfolio for customers. The unit will combine GE Healthcare's operations in India, South Asia, Africa and Southeast Asia. With the vision to improve access to quality and affordable health around the world, SHS will work with governments, clinicians, private operators and NGOs to deliver value-based solutions aimed at improving outcomes for health systems and patients. "Much of the world's population is without adequate healthcare, and innovations that can create better patient outcomes in a sustainable way are urgently needed," said Mr John Flannery, president and CEO of GE Healthcare. "Many emerging economies are looking for experienced partners to help build skills, capacity and effective healthcare solutions for their patients." GE Healthcare has a long track record in developing innovations for emerging markets. For example, its handheld ultrasound device Vscan Access+ and Lullaby+ infant warmer are improving outcomes in remote rural settings in maternal infant care, a major focus area for many emerging markets. The low-cost healthcare equipment sector alone is now estimated to be worth over $8 billion and growing significantly as developing countries continue to invest in effective, long-term healthcare solutions to improve the health of their populations. "SHS will leverage GE's Fastworks methodology to accelerate, test and rapidly commercialize relevant, affordable technologies. By taking this 'start-up' model approach we can rapidly test new ideas, products and services to maximize effectiveness for customers before we scale up," said Ms Terri Bresenham, president and CEO of GE Healthcare's Sustainable Healthcare Solutions unit. "From basic primary care delivery through to more complex, structural healthcare challenges, SHS will aim to combine GE Healthcare's capabilities and scale with the local know-how and expertise of our partners across Africa, Southeast Asia, India and South Asia. "   ]]> https://biospectrumindia.com/news/97/6302/ge-healthcare-biotic-to-work-on-medical-imaging-software.html https://biospectrumindia.com/news/97/6302/ge-healthcare-biotic-to-work-on-medical-imaging-software.html Wed, 23 Sep 2015 11:50:42 +0530 A new collaboration between GE Healthcare Canada and BIOTIC will initiate a Halifax-based research and development (R&D) and technology commercialization program with the aim of bringing software technology advances to medical imaging. The collaboration draws on the recent acquisition of GE Healthcare's 3T magnetic resonance imaging (MRI) technology at the QEII Health Sciences Centre (QEII) and BIOTIC's expertise in medical imaging based technology development, to explore the application of advanced software solutions to better diagnose and treat diseases of the brain, liver and prostate. The goal of this collaboration is to validate and commercialize software-powered medical imaging technology for eventual world-wide use as added solutions and features to GE Healthcare's MRI systems. Each products is being developed as "pushbutton"-- improving efficiency, consistency and accuracy of the MRI results - potentially improving care for patients in Nova Scotia and around the world. "GE Healthcare is keen to invest in collaborations that draw on the best capabilities from Canada's leading health care providers and research organizations to help commercialize products with the potential to advance our understanding and treatment of disease," said Ms Heather Chalmers, general manager for GE Healthcare Canada. "This collaboration with BIOTIC will draw on the considerable expertise in Nova Scotia to improve patient care for the Province and potentially the world." The products being developed include technology focused on providing automated software solutions in the areas of: pre-surgical functional brain mapping, liver disease and prostate cancer.   "BIOTIC has a diverse team of scientists, clinicians and technicians. After receiving a high-field MRI from a QEII Foundation donor, we knew we had the infrastructure, capability and drive to get the attention of a multinational company. Working with the GE Healthcare team in Canada has been great; they are innovative, forward-thinking and we expect to make some dramatic improvements to patient care through our collaboration," said Dr Steven Beyea, scientific lead for BIOTIC. The collaboration is underway, with a timeline to design, develop, test and commercialize the products over the next five years.     ]]> https://biospectrumindia.com/news/97/4258/ppd-earns-awards-for-digital-communications-.html https://biospectrumindia.com/news/97/4258/ppd-earns-awards-for-digital-communications-.html Tue, 22 Sep 2015 14:01:41 +0530 Pharmaceutical Product Development (PPD) has announced the company earned recognition for excellence in multimedia and digital communications that promote the people and technology vital to advancing the development of life-changing medicines. PPD earned five honors in the annual Telly Awards and three in the Digital Health Awards. PPD earned honors in both awards programs for its treatment of Preclarus, the company's award-winning clinical data portfolio solution that delivers real-time data and analysis to power improved clinical trial quality and efficiency. Preclarus gives PPD and client teams transparent, real-time access to all clinical trial operations and patient data to enable faster strategic and tactical decisions about clinical studies. PPD also received recognition for its video, "How Wendy Chioji Beats Cancer," featuring a PPD Hero in the PPD Beach2Battleship Triathlon. PPD Heroes are everyday people who have overcome illness with medical treatments developed in clinical research and who raise awareness about the importance of increasing participation in clinical trials. "We believe in the power of digital and multimedia communications to effectively spotlight technological advances driving success in clinical trials and to amplify the voice of patients who depend on research to improve health outcomes," said Ms Elizabeth Kuronen, vice-president of strategic communications and marketing for PPD. "These awards underscore PPD's commitment to serving our biopharmaceutical clients and elevating the message that clinical trials can help save lives." Founded in 1979, the Telly Awards program honors outstanding local, regional and cable TV commercials and programs, the finest video and film productions, as well as Web commercials, videos and films. The Digital Health Awards honor the world's best digital health resources across a number of categories. Nearly 1,000 submissions were judged for the 17th Digital Health Awards.   ]]> https://biospectrumindia.com/news/97/7292/transasia-acquired-lumora.html https://biospectrumindia.com/news/97/7292/transasia-acquired-lumora.html Tue, 22 Sep 2015 12:04:35 +0530 Mumbai headquartered Transasia Bio- Medicals has announced its acquisition of Lumora, a Cambridge, UK based patented molecular technology company for about Rs 250 crore. This makes Transasia one of the select few global companies with its own patented technology for the Rs 35,000 crore global market for molecular testing. The acquisition will see ERBA-Transasia Group add advanced molecular diagnostics testing to its comprehensive suite of clinical testing products and make them available worldwide for testing of diseases such as HIV, respiratory diseases, dengue, malaria, etc. Global market for molecular tests is estimated to be about Rs 35,000 crore per year. Along with the specific diagnostic technologies, the Transasia Group will have the opportunity to further commercialize Lumora's patented technologies such as BART, RapidMag, and other sample preparation technologies. In addition, Lumora, has a number of ongoing commercial partnerships which will continue following the acquisition. Dr Laurence Tisi, CEO of Lumora, said, "The ERBA-Transasia Group is an excellent home for Lumora's technology. The company has a strong global presence and is well established in a number of key market segments. With the acquisition of Lumora, and its novel technology, the Group is now well placed to expand the utility of the technologies globally." Mr Suresh Vazirani, chairman and managing director of the ERBA-Transasia Group, said, "The acquisition of Lumora enhances and completes our existing portfolio of instruments & test kits, to make ERBA- Transasia a global IVD leader. Lumora has a strong portfolio of molecular technologies which will help us develop molecular testing for emerging country specific diseases such as HIV, TB, malaria, dengue etc."       ]]> https://biospectrumindia.com/features/97/7788/hot-start-up-crafting-bioabsorbable-implants-for-india.html https://biospectrumindia.com/features/97/7788/hot-start-up-crafting-bioabsorbable-implants-for-india.html Mon, 21 Sep 2015 18:05:00 +0530 PLA is a biodegradable biomaterial made from corn, sugarcane or sugar beets, widely manufactured in the United States. The biomaterial instantly attracted Dr Lele's attention due to its unique properties including being able to be absorbable inside the body and retaining the mechanical properties to a certain time period. He then introduced this product to Dr V Premnath, another chief scientist at NCL, who has his PhD from the world-renowned Massachusetts Institute of Technology (MIT). Dr Lele holds his PhD from the University of Delaware, USA. The product was promising and was sufficiently challenging to stir the enthusiasm between the two, and before long, they teamed up together to develop biocompatible maxillofacial volume filling implants. Four years later, in 2010, Mr Piyush Joshi, a polymer engineer from the University of Pune, joined them. His expertise helped them to identify the benchmark properties of the product to-be developed, and its economics.   They soon realized the importance to make bioabsorbable polymers with varied properties. All the efforts by the team were directed towards synthesis of appropriate molecular weight PLA material. The three of them participated in Venture Center's (Pune) 'Lab2Mkt' program which focuses on commercializing early-stage technologies. The idea bagged its initial funding of Rs 7 lakh from proof-of-concept (PoC) initiative. Thus the team were able to raise a small amount to setup initial experiments to synthesize the bioabsorbable polymers, and carry out further market research. With sustained market research, the trio understood that this single product will soon envisage the whole product portfolio using bioabsorbable polymers and their composites. By 2012, they went on to study and identify other products which use similar polymers.   "There were no Indian manufacturers who made biomedical grade PLA, and this was a real setback for the Indian medical device manufacturers. Surgeons had to rely on foreign players. We saw this as an opportunity and decided to use the expertise to develop the bioabsorbable materials and products for India. This was the moment when the idea was taking firm roots to be considered as a platform to create a new venture," says Mr Piyush Joshi, COO and executive director, Orthocrafts Innovations. Over the next two years, the whole team was building the chemistry know-hows of medical grade PLA, and was waiting for the appropriate funding opportunities. Mr Piyush highlights, "The opportunity struck us when BIRAC announced BIG grant funding scheme. We realized that this will be an excellent opportunity to bring our efforts to fruition. Post our participation, BIRAC approved our concept." Post which, Orthocrafts Innovations was incorporated. Dr Ashish Lele (48), and Dr V Premnath (45) serve as the start-up's director and advisor respectively.   So far, a capital of Rs 20 lakh has gone into the company. Mr Piyush believes that materials development for biomedical applications is the company's niche, and will transform medical device industry by slashing the time taken to develop products along with the costs. He adds, "We plan to capture the value in development of biomedical grade polymers which are suitable for implants, and downstream products using the same. We plan to work closely with Indian medical device users to develop newer products. Our ability to tailor materials and making them suitable for product development is the biggest strength." Mr Piyush recalls that the path was not simple during the beginning days. "Lack of ready infrastructure, non-existent dialogue between product users and product developers, lack of access to crucial raw materials, were the most common hurdles," he comments. "One of the great challenges we faced was to identify and execute suitable technology transfer model from NCL. Thanks to the team at NCL innovations for their prodigious efforts and continued support, Orthocrafts today enjoys necessary technology rights for material and product development." In its initial days, the venture also faced issues with putting the required resources such as skilled manpower, equipments and funds. However, the major challenge was in terms of taking the business idea from ideation-stage to the prototype-stage through the existing ecosystem. "There were hurdles in terms of setting up right mechanisms to transfer technology to the start-up, uncertain possibility of scientists participating in a start-up, and scarcity of scale-up funding from ideation-stage to first prototype," remarks Mr Piyush. Orthocrafts is unique in terms of a company structure, where Scientists from CSIR (Council of Scientific & Industrial Research) are allowed to take equity and be a promoter of the company. Orthocrafts is amongst the first few start-ups where CSIR's 'Scientist Entrepreneurship Scheme' has come to fruition. "So far Orthocrafts is successful in setting up a new trend among scientists, who now are thinking of shifting from traditional technology development, and transfer model," Mr Piyush points. It aims to aggressively grab opportunities to work with surgeons and hospitals to cater to their needs. Considering India's growing potential in medical tourism, the start-up will focus on multispecialty hospital chains in tier-1 cities. It also plans to establish connections with surgeons in tier-2 and tier-3 cities to increase its impact. Moving ahead, Orthocrafts intends to develop its portfolio of products by expanding into new biocompatible bioabsorbable materials such as PDLA (Poly D-Lactide) and PCL (Polycaprolactone). It is also looking forward to collaborate with institutes with strong programs on tissue engineering. "We also aim to develop next level of downstream products such as suture anchors and tacks for hernia repair. The company will also focus on building a strong IP portfolio for these materials and products as we go ahead," he shares. Its efforts will also be focused on getting products through pre-clinical and clinical trials to secure necessary approvals such as USFDA and CE mark, accompanied by ISO 13485 and ISO 10993 certifications. Orthocrafts visibility strategy includes an active website as an initial communication channel. Besides this, it also participates in various programs organized for the medical devices fraternity. "We intend to participate in various business plan competitions to improve the company's visibility," Mr Piyush opines. He also says that the Indian government has taken deliberate efforts in fostering entrepreneurial culture. "As a result of this, we see a revolution in the software sector. Indian government is taking giant efforts in replicating similar models in the biotech sector. However such efforts will come to fruition only when the youth of this country are encouraged to participate in new business ideas. Having supporting activities for entrepreneurship at undergraduate level will certainly help create more entrepreneurs in the country," he elaborates. He continues, "Today, only a handful of investment opportunities are available in engineering and the biotech sector in India. Bridging this gap will help flourish these sectors. Easy availability of risk capital at idea-stage will be of most use. I strongly believe that the government has taken steps in various efforts such as BIRAC and MSME. However, accelerated program execution will be a key to success." He notes that in the West, the economy is mainly focused on R&D intensive businesses and products. "India still emphasizes on service-based approach. Western countries have influenced policies, education system and financial markets to support start-ups as they see start-ups as economic growth engines. I would like to acknowledge here that sustained efforts for decades have helped Western countries to develop required entrepreneurial ecosystem," he says. Faster business processes, ease of winding start-ups, availability of risk capital at very early stage, and strong technology pipeline from educational institutes have given unprecedented advantage to Western countries. "Similar model may not be suitable for India considering the vast needs of Indian population," Mr Piyush suggests. "However, India has embarked its footprints on global map through frugal innovations, maximization of resources, business model innovations, and workflow innovations." As a trend in the medical devices industry, he expresses that many people are choosing in-house design and development as a main stream activity. At present, the product development emphasis is mainly on medical electronics and instrumentation. He also reveals that there are many emerging opportunities in making customized products for patients where start-ups can venture into. He considers Pune as an upcoming start-up hub apart from Bangalore and Hyderabad. "Pune has rich history of entrepreneurs, especially big business houses such as Bajaj and Poonawala group among others. Pune also has a strong educational system which provides skilled manpower for start-ups," he validates. The 30-year-old entrepreneur stresses that India is now seeing a steady growth in VCs who are venturing into the Life Sciences space. "However, the approach is more towards safeguarding the investment rather than risk-taking approach. Long gestation period for products increase the risk in Life Sciences-based start-ups," he explains. "For shareholders and investors who are looking at immediate returns, Life Science start-ups would be bad preposition," he mentions. "By the time these companies reach pilot scale, huge investment would have already been made and that increases the ticket size for such investors for far less equity. Also if joining the journey at late stages might lead to reduced returns. I believe that indexes such as GREX index is one of the most innovative way of raising start-up funds." As for Orthocrafts, one of the biggest challenges will be to navigate through the almost non-existent regulatory system in the country. "We also envisage that acceptance of products amongst the medical fraternity will take some time, but we wish to deliver a world-class innovation at the disposal of Indian surgeons. While we face strong competition from current foreign players in the Indian market, we are optimistic that we will be able to penetrate through the market," Mr Piyush says confidently. Mr Piyush counts patience and deliberate sustained efforts in achieving goals as the two most valuable qualities of being an entrepreneur in the field of Life Sciences He advises that for Life Sciences-based start-ups, joining an incubator or an accelerator is the best starting point. "Such premises brings supportive infrastructure at very lower costs. It also provides important connections to like-minded people," Mr Piyush says, for whom Ratan Tata had been a big role model. Entrepreneurs are human too. They undergo insurmountable stress at times. "There are a number of occasions where I feel highly stressed. In such situations I prefer to take a walk while listening to my favourite music by A R Rahman or Yanni. I also find that watching Tendulkar's batting as a great source of relaxation," he states. The entrepreneur also enjoys reading, music, movies, adventure sports, finding new food joints, and loves exploring vacation spots. "Entrepreneurs should not hesitate to take risks, pursue a lot of networking, and choose products carefully. Last, but not the least, always aim high," Mr Piyush ends, who says that he would have ended up being a mechanical engineer developing cars for F1 had he not been an entrepreneur. Quick Bites: Entrepreneurial Mistakes to Avoid:  Choosing inappropriate team, especially co-founders Lack of clarity on regulatory pathway Failure to sign right agreements or contracts with employees, vendors and others Failure to file strategic IPs Entrepreneurial Lessons Learnt:    Highly essential for co-founders to work in coherence in clearly defined roles Choosing products wisely  Not wasting time once the goal is clear Choosing funding partners carefully with due diligence Never hesitating to take risks   ]]> https://biospectrumindia.com/news/97/7977/ims-study-highlights-potential-of-mhealth-.html https://biospectrumindia.com/news/97/7977/ims-study-highlights-potential-of-mhealth-.html Mon, 21 Sep 2015 11:54:14 +0530 The number of mobile health applications available to consumers now surpasses 165,000, as developers incorporate innovative data collection features linked to sensors and wearables, according to a new report released today by the IMS Institute for Healthcare Informatics. While most available apps focus on overall wellness, healthcare systems and professionals are expressing greater interest and excitement in broader app use as barriers to mainstream adoption of mHealth are removed-especially in the area of chronic disease management. The IMS Institute study found that one in ten apps now has the capability to connect to a device or sensor, providing biofeedback and physiological function data from the patient and greatly extending the accuracy and convenience of data collection. Nearly a quarter of consumer apps are now focused on disease and treatment management, while two-thirds target fitness and wellness. The number and variety of mHealth apps present an overwhelming set of options for consumers, resulting in 40 percent of apps having fewer than 5,000 downloads. The study, Patient Adoption of mHealth: Use, Evidence and Remaining Barriers to Mainstream Acceptance, extends the IMS Institute's examination of consumer-focused mobile apps in the health system conducted in 2013. Researchers drew on IMS Health's proprietary AppScript Score database and analysis of 26,864 apps available in the US Apple iTunes and Android app stores-a representative sample of the most widely used mHealth apps by consumers. As part of the study, the IMS Institute also conducted structured interviews with health- and technology-focused thought leaders and executives on the role and status of healthcare apps. "While much progress has been made over the past two years, mHealth apps are still far from being a fully integrated component of healthcare delivery. Healthcare providers are actively addressing the remaining barriers. These include developing and adopting trusted platforms for ongoing apps curation and evaluation, creating practical reimbursement models and ensuring true interoperability within and across healthcare systems," said Mr Murray Aitken, executive director of the IMS Institute for Healthcare Informatics.   The report's key findings include the following: • App connectivity becomes a major focus for developers. In addition to improved user data collection capability, during the past two years the percentage of mHealth apps with the capability to connect to social networks increased from 26 percent to 34 percent, underscoring the importance of social networking in consumer engagement. Less progress has been made in enabling apps to connect and communicate with provider healthcare systems-a fundamental requirement for mHealth to realize its full value in healthcare management. • Overwhelming choice without guidance limits usefulness of healthcare apps. The total number of available mHealth apps is growing rapidly, including a 106 percent increase in the number of health-related Apple iOS apps since 2013. This can present an intimidating number of choices for consumers, leading some to simply select the most popular app and others to try multiple apps in an effort to determine what is best for them. The study found that just 12 percent of mHealth apps account for more than 90 percent of all consumer downloads, with nearly half of all downloads generated by just 36 apps. Physicians also struggle with the number of apps available and the limited mechanisms for assessing accuracy, efficacy and appropriateness for their patients. Platforms for rating, evaluating and, in some cases, certifying apps are becoming available to providers-enabling them to more confidently prescribe apps as part of disease prevention and treatment protocols. Moreover, 30-day retention rates for mHealth apps prescribed by a healthcare professional are 10 percent higher than those self-selected by patients. For prescribed fitness apps, the retention rate is 30 percent higher. • A growing movement is underway to build evidence supporting the value of mHealth apps. The majority of research studies to date focus on app usage rather than their effectiveness in improving patient outcomes or lowering healthcare costs. However, momentum is building for observational studies and randomized clinical trials that will yield evidence to support the value of apps, specifically in the areas of type II diabetes, cardiovascular disease, obesity and mental health. The number of clinical trials using mobile apps has more than doubled in the past two years, rising from 135 to 300. The majority of trials underway are interventional, underscoring the importance of providing rigorous study results to physicians in need of evidence that supports integration of apps in their treatment protocols. Demand has increased for larger clinical trials in an effort to better examine sub-populations of app users. Of the large mHealth app clinical trials that recruit patients, 53 percent are directed at the senior population-a key demographic that requires healthcare management and is targeted for increased app utilization. • Providers agree that the value mHealth apps can deliver is high, but barriers to full adoption remain. Among healthcare providers interviewed by the IMS Institute, most are confident that mHealth can improve overall outcomes, reduce the cost of healthcare and encourage patients to take a more active role in improving their health. Providers emphasized that mHealth data integrated with electronic healthcare records is critical to better clinical decision making and patient communication. With the universal enthusiasm expressed for mHealth, providers urged stakeholders to actively address remaining barriers, including: limited connectivity and integration into workflow systems; a slow paradigm shift in reimbursement processes and delivery of care; data confidentiality, privacy, security and regulatory uncertainties; lack of scientific evidence to measure the efficacy of apps; and the inability to reach the most vulnerable cohorts of patients-mainly the elderly or non-English speaking.     ]]> https://biospectrumindia.com/features/97/7696/hot-start-up-forging-ahead-with-perseverance.html https://biospectrumindia.com/features/97/7696/hot-start-up-forging-ahead-with-perseverance.html Mon, 21 Sep 2015 10:05:22 +0530 While in school, he always dreamt of being an entrepreneur someday. During his first year in college, he sensed that internet-based businesses would be the future. He started learning web development and created websites. In the third-year of his college, he started developing SaaS products as 'Cloud' seemed to be the buzz at that time. But it was an internship at the world's largest vaccine maker, Serum Institute, where it dawned on him that his enterprise would be biotechnology-oriented as he was greatly motivated by Serum's work. "I decided not to sit for placements and started my company right away," recalls Mr Pawan, the 25-year-old founder of Eumentis Informatics, a biotech analytics and consulting start-up incorporated in 2014.   Eumentis is a data analytics start-up providing analytics service and develop data-driven products in the field of Biotechnology, Life Sciences and Agriculture. Mr Pawan is from IIT-Delhi, holding both his Bachelor's and Master's degree in Biochemical Engineering and Biotechnology. So far he has self-funded the company with an investment of Rs 3 lakh, and has received support from Venture Center, Pune. After his degree, he was carrying out his research work at IIT-Delhi, and at International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi. Both he and his batch-mate, Mr Krishna Choudhary, discussed about starting their own data analytics company in Life Sciences.   Simultaneously, the duo were also applying for their respective PhD programs. Mr Pawan targeted Swiss Federal Institute of Technology (Eidgenössische Technische Hochschule Zürich, ETHZ), European Molecular Biology Laboratory (EMBL), and Sanger Institute. But was rejected in all the three places. However, Mr Krishna was offered a place for his PhD at the University of California Davis, USA. He went to pursue the program. Mr Pawan decided to stick to his decision in starting a bioinformatics company. Before establishing Eumentis, Mr Pawan spent a lot of time gathering information about the need for bioinformatics in Indian research, and then planned the services accordingly. He also wasted no time in looking out for clients right away, alongside acquiring data analytics skills. Currently, the company provides all types of bioinformatics services in genomics, proteomics, transcriptomics and systems biology. It also specializes in Next-Generation Sequencing (NGS) and its analytics, and consult researchers and companies on utilizing NGS in their research. Eumentis is developing a diagnostic test for Tuberculosis (TB) which can determine drug resistance to most of the antibiotics using NGS. Later on, it intends to develop tools surrounding clinical applications of NGS. It is looking out for partnerships with biomedical device manufacturing companies to develop the device for its TB diagnostic tool. The company is also working on big data technologies like Apache Spark to carry out large-scale and real-time analytics in healthcare (healthcare IoT data, EMR data, and hospital data). "People generally use very well-defined and straightforward bioinformatics pipelines for all types of analysis. This is not a good practice. We create very specialized pipeline for each project that we get," points Mr Pawan. According to him, the major challenge was to explore the bioinformatics outsourcing scene in India. "I found that," he explains, "very few people accepted the fact that they do not have necessary bioinformatics facility or skills to carry out modern day research. Also researchers are skeptical in outsourcing their bioinformatics work, and are hesitant to even talk about it. Thus, convincing people the need for bioinformatics outsourcing has been a major challenge." At the moment, the company provides bioinformatics services to research institutes. It also intends to continue and expand its clientele, and also cater to biotech companies that need bioinformatics work. "In the future we would like to work with all the big healthcare companies and develop big data analytics tools for them," Mr Pawan adds. Funding for tool development wasn't a cakewalk for Eumentis. "Twice we applied for BIG grant, and once for the GC-TBC grant for our TB diagnostics using NGS. We got rejected all the three times. We are planning to develop the tool on our own by bootstrapping," he reveals. As it forges ahead, Eumentis will strategize on concentrating more on developing big data analytics products for the healthcare and medical industry, and use the machine-learning algorithms to build tools to provide intelligent insights; and also develop NGS-based novel diagnostic and prognostic tests. In a year or two, the company plans to reach revenues to fund the development of its analytics products. "We would definitely expand our work to the US first, and then enter the European markets," highlights Mr Pawan. According to him, the best way to begin a start-up is to develop a kick-ass product which will automatically draw mass attention. "For our service-based business, our main source is word-of-mouth publicity. We also use LinkedIn and other social media to promote our business. Getting published in the print media is also good for start-up visibility," he expresses. He feels that the Government should start more enterprises like the Biotechnology Industry Research Assistance Council (BIRAC) that help start-ups with funding, and also open incubators for Life Science start-ups at nominal charges. "I suppose getting funds for a company in the West is relatively easier and quicker than in India. They have a very old start-up culture because of the Silicon Valley revolution," says Mr Pawan, for whom Steve Jobs has been the biggest role model and influencer. The Tatas, Elon Musk and Rahul Yadav also occupy a certain influential position in his life. Mr Pawan optimistically says that Next-Generation Sequencing is the future. "It is highly booming, and soon it will be used for all kinds of clinical applications. In the future, genome sequencing will become a norm, and the insights obtained from it would be extensively used in preventive healthcare. It is a great tool for R&D. Its adaptation into mainstream research in life sciences would be extremely beneficial for our country," he predicts. He also adds that Life Science data management and analytics, IoT for healthcare monitoring, gene editing, Electronic Health Records (EHR), lab-on-a-chip diagnostics, as some of the areas where new start-ups can venture into. Immediate returns is almost impossible in Life Sciences, he tells, when asked about how he explains to investors who anticipate immediate returns. "I would probably give the examples of all the big biotech companies in India and around the world, and the time it took for them to become successful. As it deals with lives, the product should undergo extensive testing, and the R&D is very complicated and takes a lot of time," he stresses. Mr Pawan also remarks that Pune is an emerging start-up hub in India. "The work being done by Venture Center in Pune is really helping start-ups. They provide a very nurturing environment and provide excellent guidance to start-ups. They have also created a list of biotech startups in Pune, and constantly conduct important workshops and seminars for entrepreneurs. A new biotech park was recently opened in Hinjewadi in Pune which is great place for biotech start-ups," he appreciates. He thinks that the most important qualities in being an entrepreneur in the Life Sciences industry are excellent technical knowledge and perseverance. "The life cycle of life sciences companies are much longer and it is currently difficult in India to get the funding easily when compared to e-commerce start-ups. A lot of time goes into research, which is a vital part for any life sciences company. Having a degree from a good college or university is always beneficial to begin start-ups. Also one can find very good co-founders in those places. Having a good degree and team helps a long way in securing funding," he notes. He reveals that the top ways to raise start-up cash are through angel funding, grants from government or foundations like Bill and Melinda Gates Foundation, B-Plan competitions, incubators or accelerators and bank loans. Speaking about unusual ways of funding start-ups, he comments, "Bootstrapping, crowdsourcing or crowdfunding, and money from friends and family are other ways. We at Eumentis are currently pursuing bootstrapping to run the company. I believe that in the long run, it is the best way to build a long-lasting brand," Mr Pawan opines. Should a start-up join an incubator or accelerator, or just simply begin on its own? "For me it is to grow on its own," he says. "Accelerators are kind of a shortcut that people take to earn money quickly and this makes it impossible to run a sustainable business. When you grow your business, your process foundation built from years of trial and error, becomes rock solid. For me, business is not about earning loads of money. It is about creating value and an entity that is sustainable." Mr Pawan, an entrepreneur, enjoys traveling, hiking, and trekking. He is also an avid nature lover who loves to cook and has varied interests including spirituality, philosophy, psychology, and hardware, and believes in constantly learning something new. To his credit, so far, he has learnt 10 different programming languages. He says he would have gotten a PhD and carried out research all his life had he not been an entrepreneur. As an important piece of advice to budding entrepreneurs, he mentions, "The most important lesson is to never look at peers who earn a lot more money. This depresses and forces one to take unnecessary steps just to earn money in short-term and makes lose focus in the longer run. Secondly, save as much money as possible and avoid spending too much money on hiring or getting unnecessary services. Never start a company with the aim of making tons of money, and never compromise on customer service or quality." ]]> https://biospectrumindia.com/news/97/7469/fda-nod-for-siemens-mammomat-fusion-mammography-system-.html https://biospectrumindia.com/news/97/7469/fda-nod-for-siemens-mammomat-fusion-mammography-system-.html Fri, 18 Sep 2015 11:58:15 +0530 Siemens Healthcare has announced that the US Food and Drug Administration (FDA) recently cleared the Mammomat Fusion - the latest addition to the Siemens family of full-field digital mammography systems that offers premium product features to address the specific needs of volume screening centers and small to medium-sized hospitals. The Mammomat Fusion mammography system features a new generation cesium-iodide detector - an innovative, layered configuration of the photo diodes within the detector that enables more efficient utilization of the radiation dose. The result: high image quality at a patient dose that is at or below the range of other full-field digital mammography systems, with an even lower dose delivered in cases where the patient's breast thickness exceeds 50 mm. And the system's large image matrix of 23x30 cm makes the Mammomat Fusion the right choice for screening various breast sizes. In addition to its new cesium-iodide detector, the Mammomat Fusion mammography system features selected technologies developed for Siemens' premium Mammomat Inspiration platform. The OpDose feature ensures that the radiation dose can be tailored for each patient without compromising image quality. The technologist can select the appropriate parameters in accordance with the patient's breast size and density. The screening process is also simplified for clinical staff thanks to the compact, syngo-based Acquisition Workstation (AWS). Users can load patient data directly from the radiology information system without requiring a second workstation. Clinical personnel also benefit from an intuitive, automated workflow. The system is ready for scanning with just one click, and manual positioning is extremely easy - so technologists can spend more time on the patient. "With the introduction of the competitively priced Mammomat Fusion full-field digital mammography system, Siemens proudly enables more breast centers and smaller hospitals to offer women many of the same cutting-edge technological features previously found only on our premium breast imaging systems," said Mr Martin Silverman, vice-president of X-ray Products at Siemens Healthcare North America.   ]]> https://biospectrumindia.com/news/97/4685/philips-partners-with-radboud-university-.html https://biospectrumindia.com/news/97/4685/philips-partners-with-radboud-university-.html Fri, 18 Sep 2015 11:57:53 +0530 Netherlands-based Radboud university medical center (Radboudumc) has introduced a connected digital health prototype that enables people living with diabetes and their health care providers to make more confident care decisions while managing the complexity of diabetes self-care. In its first phase, the solution both organizations are developing will focus on patients living with diabetes type 1. The system, consisting of a mobile patient app and online community, is the first to collect and connect data from electronic medical records, multiple personal health devices - including wireless glucose meters and activity monitors - and patient self-reported data. Via a smartphone or tablet, the app gives patients continuous access to important parameters such as blood glucose levels, insulin use, and nutrition and provides coaching guidance* at home and on the go. The secure online community is where enrolled patients and healthcare professionals can interact via private messaging or shared posts within a healthcare organization's clinical guidelines. In this way, patients can get feedback from their care team using the combined data and can easily share experiences with fellow patients, clinicians and caregivers. The collaborative prototype development among Philips, Radboudumc and Salesforce is available in pilot release by the end of year, with plans to introduce similar connected care solutions addressing other chronic conditions. "I am excited that we are providing people with diabetes the tools to connect all of their relevant health data and devices. Our system allows sharing of data and experiences in one community, where they can collaborate with fellow patients and their care teams in a secure environment," said Mr Jeroen Tas, CEO Healthcare Informatics Solutions and Services, Philips. He added, "There is a growing need for solutions that enhance self-management and continuity of care for those with chronic conditions such as diabetes to reduce health deterioration, re-admissions and mortality rates. This system has been designed by patients for patients and is enabling fully integrated health management and care delivery in a new, connected, efficient and highly patient-centric way." "We want to encourage and support people to take full command of their disease by providing them with the right decision tools. This fits in our mission towards patient-centered participatory health care at Radboudumc," said Mr Cees Tack, Professor in internal medicine at Radboudumc. He added, "Empowering patients to be true partners in their own health care by giving them access to their data and by facilitating collaboration is the key to driving change across populations," Lucien Engelen, Director REshape Center at Radboudumc added. "By collaborating with Philips, we're creating the digital framework necessary to make data actionable and transform how patients engage with their caregivers and social community." The system is built on the Philips HealthSuite digital platform and its new CareCatalyst. This platform securely connects devices and collects, integrates and analyzes patient data from connected consumer and medical devices, electronic medical records, and personal health data. Via this open digital platform, self-measurement sources and overall functionality can easily be extended as new digital health consumer measurement technologies become available. CareCatalyst is a digital toolkit that makes it easy for health systems, institutions and care providers to utilize the power of the HealthSuite digital platform in dedicated localized solutions. Further delivering on its commitment to support people throughout the full continuum of health, Philips also recently introduced the first in a series of personal health programs that empower consumers to stay healthier and help prevent illness.   ]]> https://biospectrumindia.com/news/97/7451/cole-parmer-introduces-new-oakton-waterproof-ph-450-and-con-450-meters.html https://biospectrumindia.com/news/97/7451/cole-parmer-introduces-new-oakton-waterproof-ph-450-and-con-450-meters.html Fri, 18 Sep 2015 10:18:00 +0530 Cole-Parmer introduces the latest fully-featured GLP complaint pH meter and conductivity meter from Oakton. The Oakton pH 450 and CON 450 Meters are waterproof and rugged enough for even the harshest environments, company claims. The meters provide automatic and manual temperature compensation to ensure accuracy even with fluctuating temperatures. Get more data at a glance-view measurements with temperature and calibration data with % slope or cell constant on a large, backlit display. Select Celsius or Fahrenheit settings to best fit your application. Up to 500 data sets can be stored and easily downloaded with USB or RS-232 cable. A calibration alarm alerts users when it is time to calibrate. The Oakton pH 450 meter also features six-point calibration-choose USA, NIST, DIN, or custom buffers. Convenient auto buffer recognition automatically identifies the correct pH meter buffer for rapid calibration. The Oakton CON 450 meter offers autorange conductivity from 0 to 199.9 mS in five ranges with automatic calibration up to five calibration points. Selectable temperature coefficient is adjustable from 0 to 10% per °C for accurate compensation of almost any solution. ]]> https://biospectrumindia.com/news/97/7778/chiltern-finalizes-the-acquisition-of-theorem-clinical-research.html https://biospectrumindia.com/news/97/7778/chiltern-finalizes-the-acquisition-of-theorem-clinical-research.html Wed, 16 Sep 2015 12:07:23 +0530 Chiltern has completed its acquisition of Theorem Clinical Research, strengthening its position as the largest mid-sized provider of comprehensive clinical development services. Chiltern now comprises 3,700 people across 47 countries, expanding its footprint in Europe, North America and Asia-Pacific. The acquisition enhances Chiltern's Oncology, Biopharma and Source offerings, broadens its therapeutic expertize and establishes new capabilities in medical device and diagnostics, clinical analytics and clinical supplies. "By bringing Chiltern and Theorem together, we have created a unique, mid-sized research partner focused on providing exceptional scientific expertise and personal service. Clients can expect the same high level of service, now with expanded capabilities. Senior leadership will still be involved in running trials," said Dr Jim Esinhart, CEO, Chiltern. "The acquisition of Theorem marks an important milestone for Chiltern. We stayed true to our mission to be a responsive, client-centric mid-sized provider, yet we enhanced our geographic coverage and service offerings in key areas. We are delighted to welcome the dynamic Theorem team to Chiltern and are pleased to announce that Dr John Potthoff, Theorem's president and CEO, has joined our board as a non-executive director," said Mr Nick Thornton, chairman, Chiltern.   ]]> https://biospectrumindia.com/news/97/7344/fujifilm-sonosite-announces-ce-mark-for-iviz-.html https://biospectrumindia.com/news/97/7344/fujifilm-sonosite-announces-ce-mark-for-iviz-.html Wed, 16 Sep 2015 12:04:31 +0530 FUJIFILM SonoSite has announced CE mark for its newest Point-of-Care solution, the iViz. Inspired by clinicians, the iViz is a new platform that augments the value of ultrasound for clinical users from hospital settings to clinics in remote villages with the ability to perform ultrasound when and where it is needed. "FUJIFILM SonoSite delivers a powerful and valuable solution to the market with the launch of iViz. It is a revolutionary tool that reaches new levels of mobility, image performance, and connectivity. Clinicians will now have access to technology that can be used on-the move, in-the-field or on-the ground," said Mr Masayuki Higuchi, president and CEO of FUJIFILM SonoSite. The iViz represents the next generation architecture and platform for Fujifilm's integration of ultrasound with medical IT. The iViz goes beyond traditional ultrasound abilities and provides clinicians with seamless access to patient vitals, online applications and learning resources. It also integrates with hospital IT and EMR systems to obtain patient demographics and submit reports, and connects securely with cloud services for sharing studies with remote providers for near-time assessments. The iViz is lightweight and specifically designed for emerging point-of-care settings where there is need for a highly accessible and mobile solution. It features a high resolution seven-inch display touchscreen, a wide dynamic range over a large viewing angle with high definition vibrant color flow images, Wi-Fi capabilities, Bluetooth connectivity, and interface ports for USB, HDMI, and audio. In addition to high resolution 2D imaging, the system supports M-Mode and Color Velocity Doppler. The iViz is available with a P21v phased array 5MHz transducer, and features proprietary software technologies: SonoHD2 Imaging Technology, and SonoADAPT Tissue Optimization Technology.   ]]> https://biospectrumindia.com/news/97/6396/researchers-decoded-the-tulsi-genome.html https://biospectrumindia.com/news/97/6396/researchers-decoded-the-tulsi-genome.html Tue, 15 Sep 2015 16:40:51 +0530 A multi-institutional team led by Dr Sowdhamini Ramanathan from NCBS, Bangalore, have produced the first draft genome of the sacred herb, Tulsi. This is an important step in understanding and identifying the genes responsible for production of metabolites with medicinal properties. The team included researchers from NCBS, inStem and CCAMP, all members of the Bangalore Life Sciences Cluster. Tulsi (Ocimum tenuiflorum), a ubiquitous herb is used for therapeutic purposes. Known for producing many aromatic compounds, Tulsi is known as 'Queen of Herbs'. The plant synthesises a wide range of bioactive compounds, known for their anti-bacterial, anti-fungal, anti-pyretic and anti-cancer properties. These compounds are metabolites, compounds that are a by-product of plant metabolism, typically used for plant self-defence. These metabolites are very poorly understood because of lack of genomic information. The team of Scientists performed the genome sequencing of O. tenuiflorum subtype Krishna, one of the non-model plants of great medicinal value. Comparative analysis of transciptomes of O. tenuiflorum subtype Krishna and Rama was also performed to detect potential differentially-regulated genes and their involvement in metabolite synthesis. They have identified a large set of genes involved in the production of specialized metabolites of medicinal interest such as apigenin, luteolin, rosmarinic acid pathway, eugenol, and ursolic acid. The availability of the whole genome of O.tenuiflorum and the sequence analysis suggests that small amino acid changes at the functional sites of genes involved in metabolite synthesis pathways confer special medicinal properties to this herb. The paper is published in the journal BMC Plant Biology.   (With inputs from NCBS news)     ]]> https://biospectrumindia.com/news/97/7187/samsung-signed-a-deal-with-healthcare-firm-premier.html https://biospectrumindia.com/news/97/7187/samsung-signed-a-deal-with-healthcare-firm-premier.html Tue, 15 Sep 2015 11:46:46 +0530 Samsung has been awarded a group purchasing agreement for General Radiography, Computed Tomography, and Ultrasound with Premier, Inc., a leading healthcare improvement company, effective October 1, 2015. The new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for Digital Radiography, CT, & Ultrasound products. "Samsung is extremely pleased to form this new relationship with Premier, a world-class organization and recognized leader in healthcare improvement. Samsung is making critical investment to help healthcare providers enhance patient care, improve patient satisfaction and increase workflow efficiency with our entire healthcare portfolio. We understand the need to improve healthcare outcomes while lowering costs. We are excited to be a partner with Premier in transforming the provider and patient experience" said Mr Phil Sullivan, NeuroLogica Division, president and CEO, Samsung. Samsung's full range of imaging solutions are designed to enhance the quality of care and transform the patient experience. The product portfolio includes Digital Radiography (DR), Ultrasound and portable Computed Tomography (CT) systems.   ]]> https://biospectrumindia.com/news/97/6849/gattefoss-india-inaugurates-a-new-technical-centre-of-excellence-in-mumbai.html https://biospectrumindia.com/news/97/6849/gattefoss-india-inaugurates-a-new-technical-centre-of-excellence-in-mumbai.html Tue, 15 Sep 2015 10:42:31 +0530 While celebrating its 10 years of operation in India, Gattefossé group initiated to expand its presence in the country through the establishment of a technical centre of excellence in Mumbai. This new facility reinforces the activity of its affiliate, Gattefossé India, run by Mr Sunil Bambarkar. The new office and technical centre was officially inaugurated on 11th September, 2015 with the presence of Mr Jacques Moyrand, Gattefossé group Chairman, Mr Agit Singh, Chairman, AGC Worldwide Associated Capsule Pvt Ltd. and Mr Yves Perrin, The Consul General of France. The centre brings together a FDA certified laboratory for pharmaceutical applications to facilitate the use of API's in formulations as well as a state-of-the-art personal care laboratory on surface area of 325 m² (3500 sqft). The staff specialists provide an essential technical interface for customers throughout India and beyond using these tools and apparatus. These new premises aim at facilitating the research and formulation work and consolidating the local assistance to customers. Olivier Midler, CEO of Gattefossé group describes its vision for the future "Our growth strategy for the company is based on two main pillars; innovation, by pursuing our significant investments in R&D and product applications, and geographical expansion by developing our business and expertise in new territories. All these efforts is to ensure our customers a responsive and adapted service specific to their markets." When looking ahead Jacques Moyrand, chairman, Gattefossé group, says "I am privileged to do my job with an experienced executive committee wisely headed by Olivier Midler, CEO of the company. My priorities are clearly linked to consolidating further the future of Gattefossé through its geographical expansion, our efforts in R&D and the establishment of additional strategic alliances." Sunil Bambarkar, Managing Director of Gattefossé India explains: "We strongly believe that Gattefossé India with its well-equipped, FDA approved, technical centre can widen its horizon and offer technical support not only to India but also to the region. This centre delivers services pertaining to the use of Gattefossé excipients in pharmaceutical dosage formulations and personal care formulations". ]]> https://biospectrumindia.com/news/97/7082/boston-scientific-receives-ce-mark-for-the-vercise-dbs-system-.html https://biospectrumindia.com/news/97/7082/boston-scientific-receives-ce-mark-for-the-vercise-dbs-system-.html Mon, 14 Sep 2015 12:23:29 +0530 Boston Scientific Corporation has received CE Mark for the Vercise Deep Brain Stimulation (DBS) System for the treatment of tremor, including the most common form of this movement disorder known as essential tremor (ET). The Vercise DBS System is said to be the first system designed to offer precise neural targeting, allowing physicians to customize therapy for patients with ET. It also features a rechargeable battery that can last up to 25 years. ET can be a progressive disorder, typically starting on one side of the body, and then gradually affecting both sides. It is most commonly seen in older adults, however the onset of symptoms may occur at any age. The exact cause for ET is unknown, but it is found to be mostly hereditary, where children of a parent who has ET have a 50 percent chance of inheriting the condition. "With the launch of the Vercise DBS System for the treatment of patients with Parkinson's disease in 2012, for dystonia in 2013, and now for tremor, Boston Scientific continues to demonstrate its commitment to provide more access to DBS therapy to more patients. We believe this advanced technology can play a critical role in improving the lives of patients who suffer from these devastating conditions," said Mr Maulik Nanavaty, president, Neuromodulation, Boston Scientific. The Vercise DBS System has both CE Mark and TGA (Australia Therapeutic Goods Administration) approval for the treatment of Parkinson's disease. It also has CE Mark for intractable primary and secondary dystonia, and is available for sale in Europe, Israel, Australia and select countries in Latin America.   In the US, the Vercise DBS System is investigational and not available for use or sale. The INTREPID clinical trial began enrollment in the US in mid-2013 to evaluate the safety and effectiveness of the Vercise DBS System for the treatment of Parkinson's disease.   ]]> https://biospectrumindia.com/news/97/7078/practo-acquires-insta-health.html https://biospectrumindia.com/news/97/7078/practo-acquires-insta-health.html Mon, 14 Sep 2015 12:07:55 +0530 Practo has announced the acquisition of Insta Health Solutions for $12 million (approx Rs 80 crore). Insta Health is founded by Mr Ramesh Emami, ex-CTO at Wipro Technologies, is a hospital management solution provider. The company will operate as a separate division in all the 15 countries it is present. "This is one of the largest acquisitions in the digital healthcare space in India. We are very excited to have them as a part of our fold. We can make inroads to many more hospitals now, we already have 10,000 hospitals on board. We will be able to provide integration with hospitals for customers to have better experience visiting hospitals," said Mr Shashank ND, founder, Practo, in a statement. "Insta is thrilled to join Practo in our quest to enable digital healthcare worldwide. We chose Practo over some other options as we felt we can together offer superior and comprehensive solutions," said Mr Ramesh Emami, in a statement. This is Practo's third acquisition post FitHo and Genii earlier this year.   ]]> https://biospectrumindia.com/news/97/7079/icon-applies-ibm-watson-clinical-trial-matching-to-oncology-trials-.html https://biospectrumindia.com/news/97/7079/icon-applies-ibm-watson-clinical-trial-matching-to-oncology-trials-.html Mon, 14 Sep 2015 12:06:52 +0530 ICON has announced that it is working with IBM to help reduce the time and costs of drug development, while also offering patients enhanced quality of care by connecting them to relevant clinical trials. ICON will tap Watson's cognitive computing power to help automate the cumbersome process of identifying patients who meet the criteria for a clinical trial, and to analyse protocols to assess trial feasibility and identify optimal trial sites. Initially, ICON is applying Watson Clinical Trial Matching to its breast, lung, colon and rectal cancer trials. The solution enables ICON to advise sponsors how many patients match their trial criteria, where they are located and how they will recruit them. IBM's Watson Health Cloud will facilitate access to de-identified patient data, including 50 million patient records contained in the data set from Explorys, which IBM acquired in April. At the same time, ICON enhances IBM Watson's capabilities by providing expertise into clinical trial protocols and clinical operations. The cost and time involved in clinical trials is considerable. More than $1.3B is spent on patient recruitment by drug developers each year and yet fewer than 5 percent of cancer patients participate in a clinical trial. It also typically takes 6-12 months to start up a global phase III drug trial and another 12 months to enroll the required number of patients. Commenting on the announcement, ICON's chief operating officer, Dr Steve Cutler, said, "Recruiting the required number of patients for clinical trials is a constant challenge for our customers and can represent more than 30 percent of total study costs. By applying IBM Watson to our clinical trials, we have the potential to revolutionise clinical trial feasibility, patient recruitment and study start-up timelines which will help our customers take significant time and cost from their development programmes." He added, "Together with IBM, we are also providing a better and faster way to connect patients with clinical trials that are most relevant to them. Today's announcement is an excellent example of disruptive innovation and represents ICON and IBM's shared vision for using industry-leading technologies and real-word data sets to improve clinical development." "Clinical trials are crucial in the drug and treatment development process, but when it comes to identifying appropriate trial candidates, there are significant data challenges, which can contribute to delays for bringing new therapies to market," said Mr Sean Hogan, vice-president and general manager, IBM Healthcare. He added, "Through cognitive computing and cloud-based data, our goal is to help our clients accelerate the time it takes to complete clinical trials and reach conclusive trial results."       ]]> https://biospectrumindia.com/news/97/6756/leucine-rich-bio-partners-with-german-firm-diadome-.html https://biospectrumindia.com/news/97/6756/leucine-rich-bio-partners-with-german-firm-diadome-.html Sat, 12 Sep 2015 09:45:00 +0530 Leucine Rich Bio and DiaDome have announced that they have entered into a partnership designed to be mutually beneficial in promoting both organizations in the field of medical diagnostics. Leucine Rich Bio is based in Bangalore and its main area of focus is a niche domain of human genome interpretation. The team behind Leucine Rich Bio uses advances in the areas of computer and information science, data management, statistics and systems biology to solve complex problems in genomics. They envision using cutting edge big data approaches along with machine learning algorithms to delve deeper into the understanding of the human genome and to develop novel solutions to drug discovery. Sigrid Passig, CEO and founder, DiaDome, said, "It is the innovative attitude of Leucine Rich Bio's team and the organization's modern approaches to their field what made it stand out for DiaDome. Our network is a platform friendly to new ideas that depart from conventions. That is why we believe the alliance with Leucine Rich Bio makes sense and it gives us great satisfaction to be promoting their products and services using tools available to us as a social network." "It is a pleasure to partner with Diadome. Both our organizations are unique in their offering and we see a huge benefit to propagating our products and services through Diadome's network," said Dr Debojyoti Dhar, director (Business Development and Innovation) at Leucine Rich Bio. In return DiaDome will be promoted by Leucine Rich Bio in their day to day business. Leucine Rich Bio will use their network of contacts to supply DiaDome with new members and encourage their contacts to register and support DiaDome. DiaDome strives to be the go-to tool for today's diagnostic community, where anybody from a laboratory technician to a production specialist to a hospital director can reap the benefits of belonging to a worldwide network of diagnostic experts. With that in mind, Leucine Rich Bio will promote DiaDome within their diagnostic circles. Both organizations are confident that this affinity will result in a mutually rewarding coalition.   ]]> https://biospectrumindia.com/news/97/6631/agilent-technologies-to-acquire-seahorse-bioscience.html https://biospectrumindia.com/news/97/6631/agilent-technologies-to-acquire-seahorse-bioscience.html Fri, 11 Sep 2015 12:08:02 +0530 Agilent Technologies and Seahorse Bioscience have signed a definitive agreement under which Agilent will acquire Seahorse Bioscience, for $235 million in cash. Seahorse Bioscience's technology enables researchers to better understand cell health, function and signaling, and how the cell may be impacted by the introduction of a specific drug, by providing real-time kinetics to unlock essential cellular bioenergetics data. "Seahorse Bioscience's unique technology is the perfect complement to Agilent's market-leading separations and mass spectrometry solutions, in particular for metabolomics research and disease research in pharma," said Mr Patrick Kaltenbach, president of Agilent's Life Sciences and Applied Markets Group. He added, "The combination of these two platforms gives scientists a more comprehensive and faster path to researching the most challenging diseases affecting mankind. Seahorse's team and technology are an ideal fit for Agilent and for our customers, and we look forward to bringing them on board." "We are proud to have enabled the exploration of bioenergetics in living cells by nearly 10,000 scientists worldwide, and to have created a new category of cell-based assay tools," said Mr Jay Teich, chief executive officer, Seahorse Bioscience. He added, "Joining Agilent, a premier, customer-focused supplier of technology to a much broader market, will give many more researchers access to Seahorse tools. And when these two technology-rich companies combine, we expect to offer a series of new products and applications that will benefit our customers." Privately held Seahorse Bioscience, founded in 2001, is headquartered in Billerica, Massachusetts, with manufacturing operations in Chicopee, Massachusetts. Regional offices are in Copenhagen, Denmark, and Shanghai, China. Seahorse Bioscience employs just under 200 people, most of whom are expected to join Agilent.   The acquisition is expected to be completed by Nov. 1, subject to local laws and regulations and customary closing conditions.     ]]> https://biospectrumindia.com/news/97/6556/phenomenex-tecan-to-co-market-automated-sample-preparation-solutions.html https://biospectrumindia.com/news/97/6556/phenomenex-tecan-to-co-market-automated-sample-preparation-solutions.html Thu, 10 Sep 2015 10:46:31 +0530 The two companies will jointly market Phenomenex Strata and Strata-X SPE sorbents adapted to Tecan's Freedom EVO series of robotics workstations. The solution is especially geared to high-throughput customers in pharmaceutical research, clinical and food testing environments using mass spectrometry detection methods. As part of the global agreement, Tecan will provide the instruments and automation support, and Phenomenex will provide the extraction chemistries as well as application and method development through its PhenoLogix group. Solid phase extraction is a widely used sample preparation technique by which compounds in mixtures are separated, prior to chromatographic analysis. Phenomenex Strata and Strata-X SPE sorbents remove unwanted contaminants, including phospholipids, and are offered in a number of unique selectivities to cover a diverse range of analytes. SPE can be a time-consuming manual process that is prone to human errors resulting in additional time and costs for laboratories to confirm or repeat tests. Execution of this process on Tecan automated platforms combined with optimized conditions from PhenoLogix will decrease implementation efforts in the lab, increase throughput while reducing human error and enable sample traceability for regulated environments. "We created this agreement with our high-throughput customers in mind," said Mr Michael McGinley, core products manager for Phenomenex. He added, "We can now bring them complete, automated solutions, simplifying the previously daunting task of adapting a manual method to laboratory automation. The engineers at Tecan have an amazing insight on how to optimally automate liquid handling and the Freedom EVO is a proven platform with an established track record for reliability." "Phenomenex has a large customer base using their SPE products," said Mr James O'Brien, head of Clinical Diagnostics for Tecan. He added, "By co-marketing our robotic workstations with their chemistries, we expect to expand our reach in these high-volume industries. The experts at Phenomenex and PhenoLogix have enhanced our knowledge of chromatography and enabled us to bring to market a product for mid- to high-throughput laboratories that increases the ROI of their high capital investment in mass spectrometry detection systems."   ]]> https://biospectrumindia.com/news/97/7802/ce-mark-approval-for-thermo-fischers-new-mass-spectrometer-.html https://biospectrumindia.com/news/97/7802/ce-mark-approval-for-thermo-fischers-new-mass-spectrometer-.html Wed, 09 Sep 2015 12:19:43 +0530 Thermo Fisher Scientific has announced that it received the in vitro diagnostics device (IVDD) CE mark for its Thermo Scientific Prelude MD HPLC, Endura MD mass spectrometer and ClinQuan MD software. Available for general in vitro diagnostic use in Europe, clinical laboratories now have access to a high-performance liquid chromatograph, mass spectrometer and LC-MS software designed and manufactured for in vitro diagnostic use in analyzing patient samples as components of laboratory-developed tests. The products will be exhibited at the 2nd Annual European Conference on Clinical Mass Spectrometry, MSACL EU 2015 Conference, Booth 12-13, and at the Salzburg Congress Centre, Salzburg, Austria. "We're strongly committed to bringing the advantages of LC-MS to the clinical market," said Mr Bradley Hart, strategic director, life sciences mass spectrometry, clinical markets, for Thermo Fisher. He added, "These three products are part of a larger initiative to make mass spectrometry more useful and accessible to clinicians."   ]]> https://biospectrumindia.com/news/97/7588/ppd-partners-with-cisys-lifesciences-.html https://biospectrumindia.com/news/97/7588/ppd-partners-with-cisys-lifesciences-.html Tue, 08 Sep 2015 11:57:52 +0530 Pharmaceutical Product Development(PPD) and CISYS LifeSciences has announced PPD's implementation of Sequence WebEAS, a new Web-based event adjudication system, through a collaboration between the two companies. Sequence WebEAS is a single, comprehensive system that automates and captures all activities, documents and data required for adjudication. It significantly reduces the administrative effort and cost needed by PPD and its biopharmaceutical clients to collect, manage and prepare dossiers for presentation to event adjudication committees (EAC). The system frees committee members to focus on their reviews by providing simple, easy-to-use dashboards and electronic classification forms. "By implementing Sequence WebEAS, PPD will help clients reduce the effort and cost associated with managing adjudication activities," said Dr Cindy Elko-Simms, vice president of pharmacovigilance for PPD. She added, "This new system will improve the overall quality of the adjudication process by providing a consistent automated approach to event identification and management. In addition, it will help reduce costs associated with overall project management and data reconciliation by having all adjudication activities and documents captured in one system. At the same time, the convenience and accessibility of Sequence WebEAS make it easy to use for adjudication committee members." The use of EACs to adjudicate research endpoints is steadily growing, driven by expanding safety requirements, especially those aimed at more rigorous evaluation of cardiovascular risk. The Sequence WebEAS data import function automates the event identification process to automatically pull in event/patient data from various electronic data capture (EDC) systems. Once into the system, the Sequence WebEAS adjudication workflow process automates document collection, dossier preparation, EAC committee selection and scheduling, and dossier distribution. This process enables the system to improve efficiency of activities and quality by maintaining consistency. "Sequence WebEAS enables PPD to establish an efficient, structured and consistent adjudication process, compiling information from various sources to provide reliable and accurate data to adjudication coordinators and committee personnel," said Mr Jim Saunders, president of CISYS LifeSciences. He added, "The system features role configurable dashboards, intuitive adjudication coordinator and committee member workflow, a robust search engine, powerful edit checks and data validation. The system also has the ability to interface with a variety of EDC platforms and includes many other features that increase compliance and greatly improve process efficiency." Sequence WebEAS enables EAC members to view all documents and data needed to adjudicate an event/patient through an easy-to-use, Web-based interface that captures all committee actions and retains the reviews of electronic forms. These proprietary interfaces for viewing event/patient data and generating electronic classification forms are highly configurable, allowing committee members to organize and present information to meet the specific needs of the indication. The system's built-in flexibility accommodates various EAC models and associated workflows.       ]]> https://biospectrumindia.com/features/97/4878/unleashing-the-power-of-exosomes.html https://biospectrumindia.com/features/97/4878/unleashing-the-power-of-exosomes.html Mon, 07 Sep 2015 17:25:58 +0530 While pursuing his PhD at National Centre for Cell Sciences (NCCS), Dr Aman Sharma (32) worked on brain tumors and his attention drew towards cancer patients who were in great physical, emotional and economical agony. He then visited a cancer hospital in Western Rajasthan and found that the lab was not researching enough on patients with cancer. That visit sparked a fiery flame within Dr Sharma, who then decided to pursue translational research, and ended up receiving the Biotechnology Ignition Grant (BIG) worth Rs 49 lakh from BIRAC (Biotechnology Industry Research Assistance Council) in 2015 to set up his own start-up venture - ExoCan. ExoCan is involved in developing unique Oncotechnology platforms for applications in cancer diagnosis, imaging and chemotherapy. It aims to develop technologies at lower costs with greater accessibility and clinically manage cancers for better survival outcomes. As a plan of action, Dr Sharma secured seed funding and developed the proof-of-concept with active association with R&D institutions in India and abroad, and has so far signed MoUs with two national level research institutions.   Contradictorily, ExoCan faced minimal initial challenges while setting up. "BIRAC's seed funding helped us to face the initial stages, and we were incubated at Pune's Venture Centre. However, the investors we interacted with showed minimal understanding of the healthcare R&D, and it looked like they were never going to take significant risks for disruptive technologies which we are trying to develop," voices Dr Sharma. The company has also applied for 3-4 other government grants which are in the pipeline. It has also been shortlisted for two other grants for the next set of rounds. ExoCan, in the next 18 months, aims to come up with its R&D product which will enter clinics after the necessary regulatory approvals. In the next 4-5 years, Dr Sharma tells that, the company would be a pioneer in developing disruptive Oncotechnologies. Once it has developed 3-4 products, it intends to expand to Europe and the US.   It is now targeting a revenue of Rs 5-10 crore in the next 2-3 years. Dr Sharma feels that the Government can invest more in innovation and technology with a focus on private companies. "Primarily, the Government should create a department in the Ministry which can nurture young entrepreneurs under one roof and form a channel to facilitate the start-up journey," he suggests. He also predicts that there is going to be a dire need for innovations in the oncology sector in next 10 years. "It might be possible that cancers would no longer be killing lives as they currently do. Moreover, the oncology industry would be driven, not by big pharmas, but by small or medium level and value-based entities," opines Dr Sharma, who is a fan of geek Nikola Tesla.   He also says that sectors like Agri-biotech and Nanomedicine as promising areas where new start-ups can venture into. He sees Pune as the next biggest hub for the country's biotech start-ups, and advices that joining an incubator is far better while erecting a start-up. Being in Life Sciences, Dr Sharma points there is a total lack of understanding by capitalists about R&D happenings in start-ups. "VCs want rapid capital recovery, wherein the Life Sciences sector requires longer incubation periods, but with greater returns. The environment of VC-funded Life Science start-up is not ready in India," he adds. Comparing the Western with Indian start-up culture, Dr Sharma says, "In healthcare, Western countries are funding more industry-related R&Ds than academic-oriented research. Also, in the West, many publicly-funded institutions are self-sustainable through the generation of patents, service models, and industry tie-ups. However, in India, majority of the R&D money goes to the publicly-funded R&D establishments, which are not producing on par products and IPs even after decades of their establishments. Thus, there should be more money influx into private sector which is driven by innovation." The entrepreneur's hobbies include meditation, cooking, new age music, poetry and visiting the Himalayas.   To those aspiring entrepreneurs, he adds, "Follow your passions. The only thing which matters is passion for the problem and the perseverance to solve it. This is the reason why we have more grass-root innovations happening in villages in India." At a Glance:Entrepreneurial Lessons Learnt:  Saying 'no' to investors if the money is not worth the time and efforts Protecting IPs aggressively Building up ties with niche experts Being assertive and strongly defending agenda Target Entities:  Cancer hospitals Cancer patients Pathology labs Publicly funded R&D institutions Oncology companies   Visibility Strategy:  Attending conferences, meetings & start-up events Engaging with print media Writing new grants Publishing research articles. Unusual Funding Methods:  Self-capital Approaching relatives Entrepreneurial Mistakes to Avoid:  A weak team No vision Accepting money from any resources Not securing IPs at the earliest Top Start-up Myths:  The belief it can't happen in India Lower survival rates Difficult to innovate Start-up acquisition by bigger players Prolonged product timeline Three Start-up Phases:  Seeding - Requires Government money and avoids VCs pressure ensuring more focus  Growing - Requires efficient manufacturing units on rented or loaned basis, having dedicated marketing chains only for Life Sciences sector, and soft loans from the Government and investors Maturation - Sustainability through monetizing IPs, licensing out only by the company, efficient tech transfer units at zonal level by the Government, and setting up platforms for budding start-ups in showcasing to the outer world   ExoCan's Products:  The portable aspect of the lung cancer device allows faster (~30 minutes to 1 hour) detection, diagnosis and therapy response monitoring in a single test. The device reduces time, cost, and travel for patients, and allows more number of patients to be tested by doctors. This increases efficiency in cancer hospitals in spite of low doctor-to-patient ratio. It also reduces multiple rounds of expensive scanning and pathology reports generation, thereby cutting down on treatment cost and time.  Early cancer screening cum diagnosis kit allows faster cancer screenings and testing for masses at minimal pathology lab settings with rapid result generation. This cost-effective pan cancer diagnosis method allows molecular bioprinting of the cancer(s) in one single test and, therefore saves on cost, time and travel for patients.  The targeted chemotherapy platform allows painless, side effects-free delivery of chemotherapy to patients and thus, reduces physical, mental, and emotional pain for families and patients. For doctors, it allows the usage of multiple drugs in combination to the effective management of cancer.   ]]> https://biospectrumindia.com/news/97/3546/siemens-healthcare-launches-mobile-x-ray-system.html https://biospectrumindia.com/news/97/3546/siemens-healthcare-launches-mobile-x-ray-system.html Mon, 07 Sep 2015 11:41:26 +0530 Siemens Healthcare introduces MULTIMOBIL 10, a high performance, low dose mobile X-ray system, which is manufactured in India and will cater to the potential demand in the entry level mobile X-ray systems. It is a versatile system powered with high frequency technology that can generate high contrast images at a low dose. The unique addition of 'zebra' design where the tube head has a zebra face and the rest of the system have zebra stripes, is an innovative, child friendly design that will allow fast and smooth scanning, especially in case of pediatric imaging. "Siemens is a pioneer in introducing mobile X-ray systems and we are proud to introduce our locally manufactured MULTIMOBIL 10 mobile X-ray system. We have effectively addressed the needs of small and medium healthcare providers by introducing this entry level mobile, analog X-ray system, which is simple to use and delivers high performance at lower dose", said Dr Richard Guest, CEO, Siemens Healthcare, India. Developed with a compact and lightweight design with a counterbalanced swivel-arm system, MULTIMOBIL 10 improves clinical workflow capabilities and allows higher flexibility in patient positioning - from recumbent, sitting or in any position in between. Challenging clinical orientations, such as abdominal and chest imaging even for obese patients are developed with ease. Its operational efficiency enables applications in a variety of clinical disciplines -- for instant bedside imaging, intensive care unit, neonatal intensive care unit, operating room, sports medicine and even in veterinary medicine. The hassle free 'plug and perform' feature of MULTIMOBIL 10 makes it a device that can be used in multiple departments and situations demanded in the medical infrastructure. The system can perform under extreme operating conditions. It delivers a constant imaging power even when the power supply voltage falls to 170 V/180 V or rises to 265 V. The easy to use operator console provides quick access to all functions and operating modes. MULTIMOBIL 10 has been designed with a convenient and safe parking position for the freely rotatable unit's head, especially when the system is being moved. The machine is capable of delivering shortest possible exposure times, virtually eliminating any motion blur.   ]]> https://biospectrumindia.com/news/97/5103/sartorius-ge-healthcare-sign-oem-supply-agreement.html https://biospectrumindia.com/news/97/5103/sartorius-ge-healthcare-sign-oem-supply-agreement.html Fri, 04 Sep 2015 12:09:38 +0530 Sartorius Stedim Biotech (SSB) and GE Healthcare's Life Sciences business has announced they have entered into a worldwide OEM (Original equipment manufacturer) supply agreement for SSB's innovative membrane adsorber purification technology, Sartobind. Under the terms of the agreement, SSB will manufacture membrane adsorber technologies for GE which will be marketed as part of GE's ReadyToProcess product offerings. Membrane adsorber ion-exchange technology is widely used in the industry for the removal of contaminants such as endotoxins and viruses during the production of protein-based drugs, and can offer manufacturers advantages compared to other techniques. Financial terms were not disclosed. Mr Reinhard Vogt, executive vice-president of Marketing, Sales and Services, Sartorius Stedim Biotech said, "This agreement with GE is exciting for the team at SSB and will further establish our innovative purification technologies into new applications, processes and platforms worldwide. We're looking forward to working with GE and to further help the dynamic and fast-moving biopharmaceutical industry meet the challenges of today and tomorrow." Ms Catarina Flyborg, BioProcess Downstream Product Leader at GE Healthcare's Life Sciences business said, "The biopharmaceutical industry worldwide is facing increasing pressure to continually reduce costs, increase efficiency and improve quality. Our vision is that an integrated manufacturing approach where every stage - from choice of cell culture media right through to selecting the best approach to purification - has the potential to improve product yields and reduce time to market. We are excited to be working with Sartorius Stedim Biotech and to be able to expand our toolbox with their innovative technologies." The new products will be marketed by GE under the brand "ReadyToPocess Adsorber".   ]]> https://biospectrumindia.com/news/97/5524/medtronic-acquires-medina-medical.html https://biospectrumindia.com/news/97/5524/medtronic-acquires-medina-medical.html Thu, 03 Sep 2015 10:47:06 +0530 Medtronic has announced it has acquired Medina Medical, a Menlo Park, Calif.-based and privately-held medical device company focused on commercializing state-of-the-art treatments for vascular abnormalities of the brain including cerebral aneurysms. "Medtronic is committed to fighting stroke through the innovative therapies we bring to clinicians and patients. Medina Medical's breakthrough technology makes it a natural fit with our Neurovascular portfolio, further strengthening our hemorrhagic stroke portfolio," said Mr Brett Wall, president of the Neurovascular division, which is part of the Restorative Therapies Group at Medtronic. "The Medina(TM) embolization device features advanced technology to treat cerebral aneurysms that we think can one day disrupt the coil market." The Medina Embolization Device(TM) is an intrasaccular 3D mesh implant that fills the inside of a brain aneurysm. This technology is designed to address clinical needs by featuring an implant with 3D self-expandable mesh that provides a scaffold across the aneurysm neck; conforms to the shape of the aneurysm; and reduces blood flow. "This acquisition offers Medina Medical a unique opportunity to bring together our breakthrough technologies with Medtronic's leading clinical, regulatory, market development, and commercial expertise," said Mr Erik Engelson, CEO of Medina Medical. "We look forward to working closely with Medtronic to provide expanded access and economic efficiencies to our clinical partners in fighting stroke - particularly aneurysms and hemorrhagic stroke." The all-cash transaction included an initial payment of $150 million plus additional payments upon achievement of key milestones. Medtronic had previously invested in Medina Medical and held an ownership stake in the company prior to completion of the acquisition, which will result in a pre-tax gain in the second quarter of fiscal year 2016. Additional terms of the acquisition were not disclosed. The transaction is expected to meet Medtronic's long-term financial metrics for acquisitions. Medtronic will report the Medina Medical product line as part of its Neurovascular division within the Restorative Therapies Group.       ]]> https://biospectrumindia.com/news/97/4560/bpl-medical-technologies-acquires-penlon.html https://biospectrumindia.com/news/97/4560/bpl-medical-technologies-acquires-penlon.html Thu, 03 Sep 2015 10:45:48 +0530 BPL Medical Technologies ("BPL Medical"), has announced the acquisition of Penlon("Penlon"), a UK-based, leading global manufacturer of anaesthesia systems and vaporizers with worldwide distribution networks. Penlon's product range complements BPL Medical's existing portfolio and will help in expanding its presence in the critical care segment. Penlon will continue to be based and operated from the UK under the leadership of the existing management team. The company designs, engineers and manufactures anaesthesia systems, vaporizers and other complementary products. These products are sourced by hospitals, pharmaceutical companies and anaesthesia system manufacturers worldwide. Penlon has a reputation for exceptional product quality and prompt after sales support and services. BPL Medical is one of the largest Indian medical devices companies with over 300 personnel and a large distributor network located across India. In August of 2013 Goldman Sachs invested in BPL Medical to fund the expansion of its medical devices business. This latest acquisition will increase BPL Medical's presence and distribution in other emerging and developed markets. Mr Sunil Khurana, chief executive officer of BPL Medical said, "This acquisition will help us penetrate the large critical care segment in India with Penlon's world-renowned technology-driven anaesthesia machines and vaporizers. BPL Medical will leverage Penlon's R&D capabilities to develop many new products suitable for India and other emerging markets. Additionally, Penlon's global reach will help expand BPL Medical's international presence."   Mr Stephen Moon, Chief Executive Officer of Penlon, said, "This partnership secures a long-term investment which underpins our product strategy to develop world class anaesthesia machines, monitors and next-generation vaporizers over the coming years. We now plan to expand our product development capabilities across the business and will bring forward a number of key projects. We will also benefit from BPL Medical's strength in India which will provide substantial growth in the years to come."   ]]> https://biospectrumindia.com/news/97/7676/medical-devices-industry-calls-upon-government-to-empower-domestic-manufacture.html https://biospectrumindia.com/news/97/7676/medical-devices-industry-calls-upon-government-to-empower-domestic-manufacture.html Wed, 02 Sep 2015 15:59:05 +0530 Industry leaders participating in FICCI Heal 2015 have called upon the government to take strong measures to drive the consumption of medical devices in the country, bring clarity to regulatory policy, correct inverse import duties and provide fiscal incentives to give the domestic manufacture of medical devices a strong impetus for growth and turn India into a global innovation hub for medical technology. Convening the 'Make in India' and its relevance to Healthcare, Mr Varun Khanna, MD, BD India, said, "The 'Make in India' campaign must be aligned with key government initiatives to create a strong impact on public health and provide safe medical care accessible to all. Therefore, it is important for the stakeholders in the medical devices and larger healthcare ecosystem to constructively engage in a dialogue to facilitate 'Make in India' for the country. The government should strengthen entrepreneurship and innovation to fulfil the clinical unmet needs leading to better patient outcomes." Mr Ajay Pitre, co-chair of FICCI Medical Devices Forum & MD of Pitre Business Ventures, said, "The need for quality healthcare services is going to rapidly expand as the Indian economy evolves. A strong domestic medical technology industry is very much possible, considering India's strengths, to help meet the country's needs for medical devices meaningfully and cost effectively. From a net importer, India can transform itself into a provider of cost-effective medical technology solutions to the whole world; provided an enabling ecosystem is put in place by the government." The experts were unanimous that the medical devices industry is poised to grow significantly in the coming years due to the huge unmet need, and it is no longer sustainable to continue with the current 80:20 import-export ratio. They called upon the government to focus on the following initiatives to turn India into a powerhouse of medical devices manufacturing: · Market Expansion - The current market of medical technology in India is an insignificant fraction of the global market. The Government needs to facilitate access and drive consumption by increasing spending in healthcare from current 1% of GDP to at least 3%.   · Regulatory Clarity - The Act separating medical devices from drugs needs to quickly come into force. It should enforce risk-based classification and allow ease of clinical trials. Also, a nodal ministry has to be made responsible for end-to-end facilitation of the medical technology industry. · Fiscal Incentives - To create a global supply chain and manufacturing in India, the Government needs to provide fiscal advantages to investors on the lines of countries like Ireland and China. Said Mr Probir Das, MD, Terumo India, "It is very important for the Government to address the issue of inverse import duties and formation of manufacturing clusters. The import of components is often more expensive in India than the import of finished goods. Zero duty or very low levels of duty on component imports will facilitate local assembly or production of medical devices." Added Mr Sunil Khurana, chairman of FICCI Medical Electronics Forum & CEO of BPL Medical Technologies, "The 'Make in India' campaign coupled with 100% FDI in this sector will provide a huge impetus in growing the medical devices sector in India. Indian medical devices companies must try attract international majors for their participation in the form of funds, technology and manufacturing partnership." He further said, "Local manufacturing will help in development of custom products suited better to our disease pattern and patient demography thereby reducing the overall cost of delivery. Manufacturers would also benefit through government purchases giving preferential treatment for domestic production. Further, we also need to develop our own quality control standards specific to Indian context." ]]> https://biospectrumindia.com/features/97/7722/global-telemedicine-market-bric-nations-expected-high-growth-rate-by-2020.html https://biospectrumindia.com/features/97/7722/global-telemedicine-market-bric-nations-expected-high-growth-rate-by-2020.html Tue, 01 Sep 2015 16:01:14 +0530 The primary concept of telemedicine is to negate the distance factor in providing lifesaving clinical healthcare. Telemedicine can be classified on the basic on technology and services used. Based on services, telemedicine can be divided into remote monitoring, store and forward (real-time) interactive services. Furthermore, based on the application, telemedicine is classified as Telecardiology, Teleconsultation, Teledermatology and Teleradiology. Telesurgery and home telehealth are not very popular in the BRIC region and are in the nascent stage. According to Transparency Market Research (TMR) firm, the BRIC (Brazil, Russia, China and India) countries have a high proportion of population that suffers from diseases like diabetes and asthma.   The BRIC telemedicine market is expected to grow with a CAGR of 15%. Another driving factor for the telemedicine market is the requirement of medical facilities in rural areas. Rural areas lack good medical facilities and hence the concept of telemedicine is very well accepted in the developing areas. The advent of high speed internet and telecommunication in these countries has made telemedicine possible and this is a factor for the continued growth of the market in these regions. The cost associated with telemedicine is often lower as compared to conventional healthcare and hence is a positive factor for the development of the market. Though the cost of telemedicine is often lower, the infrastructure cost to provide telemedicine facility is often high. This high cost, says TMR, acts as a hindrance to the development of the market along with the lack of interest from patients and doctors restraints the growth of the market.   There are still certain legal hassles in telemedicine, which have not yet been solved. The opportunity lies in developing a knowledge sharing platform to enhance the scope for telemedicine market. Also the support of the government in promoting the telemedicine market would be crucial for its development. Increasing the awareness of patients about the advantages of telemedicine is crucial for sustained growth. Some of the key players in the telemedicine market are Aerotel Medical Systems, Apollo Hospitals, IBM Healthcare and Lifesciences, Wipro, Manipal Hospital and others. ]]> https://biospectrumindia.com/news/97/4268/create-an-eco-system-for-inflow-of-higher-fdi.html https://biospectrumindia.com/news/97/4268/create-an-eco-system-for-inflow-of-higher-fdi.html Mon, 31 Aug 2015 12:06:45 +0530 Mr Sudhanshu Pandey, Joint Secretary, Ministry of Commerce, Government of India, has underscored the need for enhancing FDI in the medical device industry. While addressing the delegates at CII's Medical Technology Conference held in Delhi, Mr Pandey said that the medical device segment accounted for less than 0.5 per cent of the total inflow of FDI, which was very inadequate considering the fact that FDI was allowed both in brownfield and greenfield segments. More inflow of FDI could also make India a hub for medical device production not only for catering to domestic use but also exports. Mr Pandey also referred to the skill deficit in the country and suggested introduction of customized courses in poly-technics, ITIs and engineering colleges to create the required number of qualified professionals for the industry. He said, 'Industry to come forward with specific suggestions for skill development so that it could be dovetailed with the activities of Skill Development Councils.' Referring to the role of ancillary industry in the manufacture of medical devices, Mr Pandey said that the import dependence in the segment should be brought down. For that, it was imperative to have a strong drive towards ancillarization. The government is motivating MSMEs to be more active in the field. Support mechanisms are being evolved by the government for this end. Mr Pandey referred to the new legislation that is being brought about to regulate and harmonize the segment, which is presently covered by the Drugs and Cosmetics Act. Since the legislation might take some time, certain short term measures also can be brought to address the immediate problems of the industry such as labeling requirements etc.   He called for transfer of technology to give a leg up to the medical device industry by taking up contract designing, research, leading to manufacturing. Products sourced from India at cheaper prices are sold at higher prices abroad, denying the Indian industry the benefits. Mr Pandey exhorted industry to evolve a pragmatic pricing policy for equipment. Product pricing should be transparent, predictable and economical to make the medical treatment affordable to the common man.   ]]> https://biospectrumindia.com/news/97/7795/south-africas-adcock-plans-to-sell-its-indian-biz.html https://biospectrumindia.com/news/97/7795/south-africas-adcock-plans-to-sell-its-indian-biz.html Mon, 31 Aug 2015 12:00:52 +0530 Adcock Ingram, South Africa's second largest pharma company, has vocalized its plans to sell off its Indian business unit, Cosme Farma. A provider of branded and generic medicines, Adcock has set a starting price of Rs 4.8 billion for potential buyers. It also specializes in over-the-counter products, and has been a major supplier of hospital and critical care products. Cosme was founded in 1910 in Goa, and was acquired by Adcock in 2012 for Rs 480 crore. Cosme was involved in the manufacturing and marketing finished pharmaceutical formulations in India and abroad. It also manufactured products used in treating acne, anemia, osteoporosis, osteoarthritis, psoriasis, fungal infections, and eczema. On August 2015, Adcock released its 2015 year-end results along with its plan to formally sell its Indian unit.   "While all divisions in the South African business did well and showed improved profitability, the rest of Africa and Indian businesses continue to post losses. Downsides included a further impairment of R74.4 million to the Cosme business in India. As a result, the board has resolved to dispose of this investment at the earliest opportunity and a formal sale process will soon be commenced for this purpose," commented Mr Kevin Wakeford, CEO, Adcock Ingram, in a statement. Adcock Ingram's turnover stood at R5.5 billion, up 6.5%. "Significant additional investment would be needed to compete effectively in the Indian market.... It (India) is an absolutely massive pharma market, but dominated by massive players as well, so if you are a small player in that market, it is just going to be a battle," Mr Wakeford told Reuters. The news arrives just in time after Merck, which announced last week, about shutting of its Bangalore GeNei facility. This year, Pfizer confirmed its plans to shut its Thane plant. In 2014, AstraZeneca (AZ) and Piramal shutdown their R&D units in Bangalore and Mumbai respectively. Novartis' generic drug unit, Sandoz too followed the same route in shutting its operations at Turbhe site in Maharashtra. ]]> https://biospectrumindia.com/features/97/6937/global-biometrics-technology-market-to-reach-14-9-bn-by-2024.html https://biospectrumindia.com/features/97/6937/global-biometrics-technology-market-to-reach-14-9-bn-by-2024.html Fri, 28 Aug 2015 14:08:11 +0530 The market for biometrics technology is developing at a rapid pace, but according to a recent report from Tractica, it is in no way homogeneous. Instead, the biometrics market comprises at least 13 biometric modalities, 11 major industry sectors, and 142 individual use cases, not to mention more than 100 technology vendors and systems integrators. Tractica, a market intelligence firm, anticipates that the worldwide biometrics technology market will grow from $2.0 billion in 2015 to $14.9 billion by 2024. During that period, Tractica forecasts that cumulative revenue will total $67.8 billion. "Use cases define biometrics. Technology enables, but does not define this market," says principal analyst Mr Bob Lockhart. "Our research indicates little evidence of point solution selling or customers being seduced by cool technology. Even vendors with unique technology talk first about solving problems."   Mr Lockhart adds that, while all biometric modalities will experience growth during the coming decade, the largest revenue opportunities lie with fingerprint recognition, voice recognition, and iris recognition. Other notable modalities that will have a place in the market include facial recognition, vein recognition, facial thermography, electrocardiogram (ECG) recognition, retina recognition, and DNA recognition. ]]> https://biospectrumindia.com/news/97/6901/tech-firm-xerox-to-buy-rsa-medical-.html https://biospectrumindia.com/news/97/6901/tech-firm-xerox-to-buy-rsa-medical-.html Fri, 28 Aug 2015 12:25:41 +0530 Xerox has announced a definitive agreement to acquire RSA Medical. The acquisition, once closed, will expand Xerox's portfolio of healthcare service offerings to payers and life insurers using predictive analytics to enhance member outreach services aimed at improving overall population health. RSA Medical is a provider of health assessment and risk management for members interacting with health and life insurance companies. Integrating RSA Medical into Xerox's Commercial Healthcare Services business will expand the company's ability to support healthcare payers throughout all stages of member engagement, including application and enrollment, operations and claims management, customer care, and population health management. Ms Kelly Rakowski, senior vice-president, Healthcare Payer Services at Xerox said, "With this acquisition, we will help health plans educate new enrollees about services available to them and close gaps in care when necessary. We will also provide payers with insights into population health trends, and coordinate timely and personal clinical interventions for at-risk individuals and populations." Powered by its proprietary MedGine platform and individualized patient-engagement capabilities, RSA Medical utilizes population-health focused data analytics that enable health plans to support early identification of medical conditions and other risk factors, increasing payers' ability to assist their members in maintaining wellness and managing chronic medical conditions. "Xerox's powerful brand, extensive market coverage and focus on innovation will accelerate the growth of our services," said Mr Rocco Salviola, founder, president and CEO of RSA Medical. He added, "The strong cultural fit and integration of our businesses will benefit clients of both companies by creating opportunities to seamlessly leverage Xerox's full portfolio of commercial healthcare service capabilities throughout the entire member care experience. RSA Medical will continue advocating for members by helping them navigate any and all insurance interactions with the end goal of controlling and preventing the onset of chronic diseases."   The RSA Medical management team and its employees will remain with the company with Salviola leading operations and reporting to Ms Rakowski.The transaction is subject to customary closing conditions and is expected to close in the third quarter of 2015. Terms of the transaction were not disclosed.   ]]> https://biospectrumindia.com/features/97/7756/despite-impressive-advances-prosthetics-to-struggle-to-clear-reimbursement-hurdles.html https://biospectrumindia.com/features/97/7756/despite-impressive-advances-prosthetics-to-struggle-to-clear-reimbursement-hurdles.html Thu, 27 Aug 2015 17:02:45 +0530 The global market value for prosthetics will rise slowly from just over $1 billion in 2014 to approximately $1.21 billion by 2021, with reimbursement difficulties remaining the largest obstacle to growth in this medical device segment, according to research and consulting firm GlobalData. The company's report states that this increase, which will occur across the 10 major markets of the US, France, Germany, Italy, Spain, the UK, Japan, India, China, and Brazil, represents a tepid Compound Annual Growth Rate (CAGR) of 2.6%. However, Ms Jennifer Ryan, GlobalData's analyst covering medical devices, says incredible emerging technological advancements in prostheses that improve user comfort and functionality, including devices wired into the user's nervous system, offer an exciting frontier for market growth during the forecast period, providing reimbursement issues can be resolved. Ms Ryan explains: "Recent trends in prosthetics focus on socket design for improved user comfort, as well as enhanced device functionality with less user energy expenditure. Particular attention has been paid to upper extremity device improvements, due in part to the number of amputees returning from global conflicts. The analyst adds that procedures integrating prostheses into the user's nervous system for optimal device control, including targeted muscle reinnervation and targeted sensory reinnervation, have the potential to drive growth in the prosthetics market.   However, as reimbursement is generally capped for prosthetics, there is limited access to the most innovative devices, with the majority of patients only receiving a simple prosthesis. Ms Ryan continues: "Tightening healthcare budgets, combined with the extremely high cost of the newest technology, creates complications for payers. As a result, both public and private insurers are increasingly emphasizing the requirement for strong clinical evidence before granting reimbursement for newly-approved, advanced prosthetic devices. "However, the combination of an aging global population, growing amputation numbers due to trauma in emerging markets, and diabetic or vascular complications worldwide, as well as an increased awareness of prosthetic users' needs, will continue to drive the market," the analyst concludes. ]]> https://biospectrumindia.com/news/97/6624/siemens-launches-three-new-hematology-systems-.html https://biospectrumindia.com/news/97/6624/siemens-launches-three-new-hematology-systems-.html Thu, 27 Aug 2015 11:37:53 +0530 Siemens Healthcare launches three new scalable hematology systems: the ADVIA 360 System, ADVIA 560 System and ADVIA 560 AL System. These lower capacity systems offer state-of-the-art hematology testing capabilities for small to mid-sized laboratories and can also be used as back-up systems for larger diagnostic setups. "We are proud to expand our family of scalable hematology analyzers with flexible and intuitive options to suit the demographic requirements of different laboratories in India. Siemens' scalable options have been designed to meet the needs of our customers by giving accurate, reliable, easy-to-use and cost-efficient hematology solutions for different testing volumes," said Mr Richard Guest, CEO, Siemens Healthcare, India. The systems offer fast, high quality CBC testing, running up to 60 samples per hour. Engineered for safety and ease-of-operation, the new ADVIA hematology systems help optimize and manage workflow through several convenient features, such as the choice of open- or closed-tube sampling and customizable result printing. Automatic anti-clogging and cleaning procedures are employed to ensure results reliability. Along with automated maintenance, this reduces manual procedures and biohazard exposure. Other features include: the option for manual or automatic calibration procedures, a cap-piercing function for accurate and safer sampling, a multilingual operating menu and bidirectional LIS communication for easy patient data transfer between laboratories and minimized paper-based work lists. With a compact footprint, the ADVIA 360 System allows smaller laboratories to efficiently generate reliable and accurate results while conserving precious benchtop space. This system provides a three-part white cell differential and storage capacity for 10,000 results. An integrated ticket printer streamlines results reporting. The ADVIA 560 System can serve as the primary hematology analyzer in small to mid-sized laboratories and as a backup for the company's ADVIA 2120i System in larger laboratories. It provides a five-part white cell differential and storage capacity of 100,000 results. Also, two scattergrams and two histograms per result help aid interpreting disease-state information. The ADVIA 560 AL System offers automatic sampling with an optional autoloader that simply plugs into the side of the system for even greater workflow efficiency and true "walk-away" capability.       ]]> https://biospectrumindia.com/news/97/6629/ge-healthcare-partners-with-temple-health-.html https://biospectrumindia.com/news/97/6629/ge-healthcare-partners-with-temple-health-.html Thu, 27 Aug 2015 11:36:00 +0530 Temple University Health System (TUHS) and GE Healthcare has announced a pioneering collaboration between a healthcare technology company and an academic medical center that aligns incentives to promote value by providing higher-quality radiologic imaging services more efficiently at a lower cost. The new arrangement targets improvements in specific operational, clinical and financial outcomes, putting TUHS on the cutting edge of delivering high-value imaging services across a health system and making GE Healthcare a pioneer in what could become a preferred business model over the next few years. Under the seven-year agreement, TUHS and GE Healthcare will work together to achieve performance goals enabled by new technology and industry best practices. TUHS will modernize its radiological imaging equipment with state-of-the art technology from GE, while also benefitting from enhancements, including data storage and retrieval, service contract consolidation and consultation to optimize scheduling and workflow efficiency. The arrangement includes financial incentives aligning the parties toward realizing shared objectives, including a targeted $39 million in operational savings over the life of the contract. "Like many health systems throughout the country, Temple University Health System faces clinical, operational and financial demands. GE Healthcare understands these market challenges, and we are dedicated to helping customers deliver the best outcomes in today's environment," said Mr Jeffrey Immelt, chairman and CEO of GE. He added, "GE is honored to work with Temple University Health System in this strategic alliance designed to improve operational and clinical outcomes while reducing costs by $39 million." "This collaboration represents a new chapter in value-based healthcare contracting strategies," said Dr Larry R Kaiser,president/CEO and dean of Temple's healthcare enterprise. He added, "Our collaboration with GE Healthcare provides Temple physicians and patients with access to the latest imaging technology while reducing its costs by millions of dollars, improving patient convenience and safety, enhancing clinical quality, increasing hospital efficiency, and promoting the Triple Aim of better care and better health at lower cost."  The strategic arrangement between TUHS and GE Healthcare applies to the radiology departments at Temple University Hospital's Main, Episcopal and Northeastern campuses; Fox Chase Cancer Center and Jeanes Hospital.     ]]> https://biospectrumindia.com/news/97/6620/medtronic-to-acquire-medtech-start-up-twelve-.html https://biospectrumindia.com/news/97/6620/medtronic-to-acquire-medtech-start-up-twelve-.html Thu, 27 Aug 2015 10:30:00 +0530 In support of the company's therapy innovation strategy, Medtronic has announced that it has signed a definitive agreement to acquire Twelve, a privately-held medical device company based in Redwood City, Calif., focused on the development of a transcatheter mitral valve replacement (TMVR) device. "Upon close, this acquisition will strategically augment our existing capabilities in the transcatheter mitral space, which represents an important growth opportunity for Medtronic," said Mr Sean Salmon, senior vice-president and president, Coronary & Structural Heart, Medtronic. He added, "We have followed the transcatheter mitral valve space closely and firmly believe that Twelve has the most novel technology along with a strong, proven team. The combined strengths of our organizations will significantly accelerate our ability to deliver an exciting and differentiated therapy to patients, physicians and healthcare systems around the world." Mitral regurgitation occurs when the heart's mitral valve fails to close normally, allowing blood to flow backward when the heart contracts. Over time, this will lead to declining heart function and heart failure. The TMVR device under development is being designed to treat patients with mitral valve regurgitation in whom standard restorative surgery is not recommended. The majority of these patients are largely underserved with limited treatment options. Mr Andrew Cleeland, president and CEO, Twelve said, "Twelve's technology is a truly creative solution that brings together valve technology with a unique and highly differentiated dual-stent fixation design. Our acquisition by Medtronic will create a tremendous opportunity to leverage Medtronic's expertise and proven success in the structural heart space to advance the treatment of mitral regurgitation." Medtronic has agreed to pay up to $458 million for Twelve including $408 million at closing and $50 million on achievement of CE Marking. The cash- and debt-free transaction remains subject to customary closing conditions, and is expected to close in October 2015.         ]]> https://biospectrumindia.com/news/97/6319/medtronic-announces-the-launch-of-the-cd-horizon-solera-voyager-spinal-system.html https://biospectrumindia.com/news/97/6319/medtronic-announces-the-launch-of-the-cd-horizon-solera-voyager-spinal-system.html Thu, 27 Aug 2015 10:15:00 +0530 Medtronic has announced the launch of the CD HORIZON SOLERA VOYAGER Spinal System for Minimally Invasive Spine procedures. Available in countries around the world, the new system expands upon the transforaminal lumbar interbody fusion (TLIF) procedure by offering multiple, minimally invasive rod insertion options and enabling a seamless 3D-navigated surgical experience. With the CD HORIZON SOLERA VOYAGER System, surgeons have the flexibility to use either a percutaneous or Wiltse minimally invasive approach for rod insertion depending upon their preference. The system also features a low-profile, extended-tab screw with inner threading, which eases rod insertion and facilitates rod reduction. In addition, the system is part of Medtronic's Surgical Synergy Spinal Platform, the most integrated portfolio of navigated surgical technologies which seeks to minimize the operating room from interruption and constraints and gives surgeons the freedom to focus wholly on their patients. "Medtronic is known for our life-changing innovations and groundbreaking technologies. That legacy, along with our broad portfolio and collaborative partnerships enables us to truly make an impact on patient care. This system represents our commitment to take minimally invasive techniques and 3D-navigated surgery even further and develop solutions with clinical and economic value," said Mr Doug King, president of the Spinal business and senior vice president of Medtronic.   ]]> https://biospectrumindia.com/news/97/6971/merck-confirms-shutting-bangalore-genei-facility.html https://biospectrumindia.com/news/97/6971/merck-confirms-shutting-bangalore-genei-facility.html Wed, 26 Aug 2015 16:12:10 +0530 The company confirmed with BioSpectrum that the production at the facility had been stopped since July 31, 2015, and that the decommissioning activities are in progress. As part of Merck Millipore's (the life sciences tools division of Merck KGaA) strategy, it has been decided to stop supply of GeNei products and close the Merck Bangalore Site 02 - GeNei facility, said the company's spokeswoman. GeNei was involved in the manufacturing of reagents, lab wares and chemicals, and was started by Dr P Babu in the eighties. GeNei was later acquired by Merck in 2009, which was part of Sanmar Group, an Indian conglomerate MNC now valued at US $1 billion, headquartered in Chennai. Sanmar's business sectors include chemicals, engineering, and shipping.   Moving forward, Merck Millipore will continue to focus on its core businesses building on the inherent strengths in genomics, proteomics, cell culture, cell analysis, western blotting, disease research tools, analytical sample preparation and bio chemicals. The site employed 39 full-time employees and 12 contract personnel. The company said that Merck's management has been in detailed dialogue with the impacted employees, supporting their transition, and evaluating possible alternate opportunities. Despite the shutdown, Merck stated that, for it, India has, and will be a priority market, and will continue to be so. In June 2014, Merck Millipore erected its first Solid Dose Formulation Lab in Mumbai, outside Europe. According to Merck's Q2 2015 reports, Indian and Chinese markets have been its main growth drivers, with APAC region recording net sales at 33%, followed by Europe at 31%, and North America at 20%. In January 2014, AstraZeneca announced the shutting down of its iconic Avishkar R&D site in Bangalore. In August 2014, Indian healthcare giant Piramal officially announced its decision to shut its Mumbai R&D unit. Recently, Pfizer's Thane plant was also written-off for shutting down its operations. Sandoz too, vocalized its plans to lockup its Turbhe site in Maharashtra, this year. ]]> https://biospectrumindia.com/features/97/6107/hybrid-clouds-to-witness-highest-growth-by-2020.html https://biospectrumindia.com/features/97/6107/hybrid-clouds-to-witness-highest-growth-by-2020.html Tue, 25 Aug 2015 14:41:42 +0530 Healthcare cloud computing is used to share patient information between healthcare providers and pharmacists. It also plays a vital role in patient billing and reduces capital expenditure which is associated with conventional mode of billing practices. It increases the speed and flexibility of healthcare services such as telemedicine, electronic medical records, and image diagnostic techniques. Mobile devices are gaining popularity in delivering healthcare services. According to ReportLinker, a search engine, various factors such as increasing demand for better healthcare facilities, rising government initiatives and cost effectiveness are driving the global market for healthcare cloud computing.   In addition, rising investments from healthcare IT players and growing popularity of wireless and cloud technology are some of the major drivers for the global healthcare cloud computing market. However, lack of experienced professionals is key restraint for the global healthcare cloud computing market. In addition, lack of security and privacy of patient's information also obstructs the growth of the global healthcare cloud computing market. The US represents the largest market for healthcare cloud computing in North American region. This is due to improved healthcare infrastructure and technological advancements. Asia is expected to experience high growth rate in the next five years in global healthcare cloud computing market.   This is due to improving healthcare infrastructure and increasing government spending on healthcare IT. In addition, several government associations are also supporting in growth of the healthcare cloud computing market in Asia. Various factors such as increasing demand for better healthcare facilities, rising government initiatives and cost effectiveness are driving the global market for healthcare cloud computing. In addition, rising investments from healthcare IT players and growing popularity of wireless and cloud technology are some of the major drivers for the global healthcare cloud computing market. However, lack of experienced professionals is key restraint for the global healthcare cloud computing market.   In addition, lack of security and privacy of patient's information also obstructs the growth of the global healthcare cloud computing market. Increasing usage of portable devices, such as cell-phones and laptops, to access healthcare services is the key trend for the global healthcare cloud computing market. ]]> https://biospectrumindia.com/news/97/5821/illumina-in-diagnostic-deal-with-burning-rock.html https://biospectrumindia.com/news/97/5821/illumina-in-diagnostic-deal-with-burning-rock.html Tue, 25 Aug 2015 13:04:12 +0530 Burning Rock and Illumina has announced they have entered into an agreement whereby Burning Rock will develop advanced clinical applications for molecular diagnostics in oncology based on Illumina's next-generation sequencing (NGS) technology. The collaboration between Burning Rock and Illumina will focus on providing the most advanced and integrated sequencing solutions to the clinical market by combining Illumina sequencing technology with Burning Rock's advanced clinical application development capabilities. In particular, the two companies will work together to develop a user-friendly, oncology molecular diagnostic kit for the Chinese market. As part of the agreement, Burning Rock will provide its nucleic acid extraction, library preparation, and data analysis software, while Illumina will provide NGS instrument components and related reagents. "We have been working to promote the clinical application of genomic technology in China. Oncology molecular diagnosis based on NGS, including non-invasive testing, is being applied in the clinic and we hope to promote it as a standard practice in hospitals. As the leader in oncology molecular diagnosis, Burning Rock is now very pleased to partner with Illumina, the global leader in sequencing and array-based technologies. Cooperation between our two companies will provide additional high-quality molecular diagnostic solutions in the clinical field of oncology," said Mr Yusheng Han, founder and chief executive officer of Burning Rock. "Illumina is very excited to collaborate with Burning Rock to increase access to oncology diagnosis solutions in China. We are committed to partnering with Chinese companies who share our vision of improving human health by unlocking the power of the genome," said Dr Rick Klausner, senior vice-president and chief medical officer of Illumina.   ]]> https://biospectrumindia.com/news/97/7559/now-compare-healthcare-costs-before-availing-any-treatment.html https://biospectrumindia.com/news/97/7559/now-compare-healthcare-costs-before-availing-any-treatment.html Mon, 24 Aug 2015 15:48:36 +0530 It is an innovative platform for patients to connect with doctors, clinics & hospitals in a very effective way. This web-based platform simplifies the health care selection process for the patients. On the other hand it provides a powerful medium to health care service providers to disseminate information about their expertise & reach out to thousands of patients not only in the same city but around the world. It is a win-win approach for both patients and health-care service providers. This web and smart phone based App will help patients to request for appointments 24/7.   Confirmation emails and messages will be sent to their mobile phones. The process will also expand the health care market as thousands of patients who ignore their health due to cumbersome or no appointment system now feel more comfortable to get themselves treated by health-care service provider of their choice. Majority of the patients spend lots of time, money and energy to get this basic information. Since 83% of Indian population is uninsured or under insured, sensitivity towards health care cost is very high. Average patients visit several hospitals, wait in unending queues, undergo pain and mental agony to find cost of surgery.   All this can now be done online by uploading medical records. Patients can compare health-care cost estimates and then take informed decisions. Currently majority of the patients are seeking advice from their colleagues, friends or neighbors to find right hospitals and doctors for them. With this portal, patients will be able to take their own decisions by researching more about health care providers on-line. Power of finding the right health-care provider will shift to the patient directly.   The portal is neutral about any given health-care provider and will not recommend any particular health-care service provider. Health-care providers will be able to increase their reach and visibility to thousands of patients around the globe and attract more medical tourists in the country. One of the weak links currently is access to aggregated and authentic information to the patients outside India and these kind of portals will help bridge the gap. The platform has has 20,000+ doctors and hospitals listed in 230 cities in India. With its gaining popularity, it is expected that this number should double by end of this year. ]]> https://biospectrumindia.com/news/97/7539/govt-to-launch-tele-medicine-services.html https://biospectrumindia.com/news/97/7539/govt-to-launch-tele-medicine-services.html Mon, 24 Aug 2015 12:22:45 +0530 The Ministry of Communications and Information Technology in partnership with the Apollo Hospitals will launch tele-medicine services on August 25. Under the service, people can visit Common Service Centres (CSC) and fix an appointment for seeking expert consultancy with a doctor. The doctors at Apollo Hospitals will be able to provide consultancy to the patients using the video link facilities. People can also order generic drugs online. The Department of Electronics and Information Technology (DeitY) has a network of 1.5 lakh CSCs across the country and Apollo Hospitals will provide the services using the network. The services will be launched in 60,000 CSCs across the country. The Ministry of Health will also extend the benefit of their Jan Aushadhi programme of delivery of generic drugs through the CSC network. "The CSC and Bureau of Pharma PSU of India (BPPI) will sign an MoU for providing these generic drugs to citizens through CSC network," said a Ministry official, in a statement.   ]]> https://biospectrumindia.com/news/97/7548/google-announces-life-sciences-under-alphabet.html https://biospectrumindia.com/news/97/7548/google-announces-life-sciences-under-alphabet.html Mon, 24 Aug 2015 12:22:07 +0530 Google co-founder and Alphabet president Mr Sergey Brin in a blog post has announced Life Sciences as the first new company created under the Alphabet umbrella. "It's a huge undertaking, and I am delighted to announce that the life sciences team is now ready to graduate from our X lab and become a standalone Alphabet company, with Mr Andy Conrad as CEO," Mr Brin wrote in the blog. While the reporting structure will be different, their goal remains the same. They'll continue to work with other life sciences companies to move new technologies from early stage R&D to clinical testing-and, hopefully-transform the way we detect, prevent, and manage disease, he mentioned in the blog. "The team is relatively new but very diverse including software engineers, oncologists, and optics experts. This is the type of company we hope will thrive as part of Alphabet and I can't wait to see what they do next," he added. The company is presently working on developing Smart contact lenses that can monitor the blood sugar levels of diabetics.   ]]> https://biospectrumindia.com/news/97/6447/targeted-genetic-testing-to-reduce-treatment-costs.html https://biospectrumindia.com/news/97/6447/targeted-genetic-testing-to-reduce-treatment-costs.html Thu, 20 Aug 2015 17:04:00 +0530 Genetic testing has so far gained considerable traction in clinical setting for prevention, diagnosis, treatment and management of diseases with an underlying genetic reason. "Genomics can enable the next level of medicine in the clinical setting," said Dr Thomas Mathew, HOD, department of neurology, St Johns Medical Hospital, Bangalore, along the sidelines of a round table meeting organized by MedGenome, a genomics-based diagnostics and research start-up, with the hospital's neuro-specialists. Dr Mathew further added, "Targeted genetic testing in Indian patients has a potential to reduce the overall cost to the patient with more accurate diagnosis and management." The panel of neurologists discussed genomics being an enabler in their clinical practice and on common diseases such as Duchenne Muscular Dystrophy (DMD), Leigh Syndrome, Juvenile Parkinson's disease and Epilepsy. Genomics is also applied in pharmacogenomics to understand the efficacy of a drug in an individual patient; identifying root cause of complex diseases running in families; and more definite diagnosis for common diseases where the underlying genetic causes are known. ]]> https://biospectrumindia.com/news/97/6942/illumina-partners-launch-helix.html https://biospectrumindia.com/news/97/6942/illumina-partners-launch-helix.html Thu, 20 Aug 2015 12:46:34 +0530 Illumina, Warburg Pincus and Sutter Hill Ventures have announced that they have formed a company to empower consumers to discover insights into their own genomes through a vibrant ecosystem of high-quality content partners. The company, called Helix, is based in the San Francisco Bay Area and received financing commitments in excess of $100 million. Mr Jay Flatley, CEO of Illumina, will serve as Chairman of the Board. Helix will enable individuals to acquire an unprecedented amount of genetic information by providing affordable sequencing and database services for consumer samples brought through third party partners, driving the creation of an ecosystem of consumer applications. After being sequenced, individuals will be able to manage their data and explore an open marketplace of on-demand applications, provided by Helix's partners, to gain additional insights into the genomic data that has already been acquired. By converting genetic information to digital data stored in the cloud, Helix enables its partners to develop and deliver premium genomic products to consumers without the burden of developing their own assay, laboratory, or database infrastructure. "Genomics is reaching an inflection point in cost, volumes, and knowledge, creating a significant opportunity to unlock information that is currently not widely accessible to individuals. Helix and its founding investors are committed to creating a neutral platform at the highest quality standard that will work with partners to accelerate consumer adoption of genomics," said Mr Flatley. Helix has also announced two collaborations with major partners. First, the Center for Individualized Medicine at Mayo Clinic is collaborating with Helix to develop applications initially focused on consumer education and health-related queries. As part of the collaboration, Mayo Clinic also made a strategic investment in Helix.   Second, Laboratory Corporation of America Holdings (LabCorp) will develop and offer innovative analysis and interpretation services, initially focused on medically actionable genetic conditions, to consumers through Helix's platform. Helix expects that other partners will develop applications focused on areas such as genealogy, fitness or wellness, and inherited traits to enable insights related to an individual's genetics. To support its partners, Helix will establish one of the world's largest next-generation sequencing labs and a secure and protected database, all designed in accordance with CLIA, CAP, and HIPAA guidelines. Individuals will be able to control how their data is accessed through a robust and granular consent process. The company will also ensure that information is communicated to consumers in a responsible and ethical way. More information will be available at www.helix.com.     ]]> https://biospectrumindia.com/news/97/6930/roche-to-buy-kapa-biosystems.html https://biospectrumindia.com/news/97/6930/roche-to-buy-kapa-biosystems.html Thu, 20 Aug 2015 12:44:55 +0530 Roche has announced that it has signed a definitive agreement to acquire Kapa Biosystems (Kapa) a privately-held company headquartered in Wilmington, Massachusetts, USA. Kapa Biosystems is a provider of genomic tools in the life sciences sector that employs proprietary technologies to optimize enzymes for next-generation sequencing (NGS), as well as polymerase chain reaction (PCR) and real-time PCR applications. Kapa's proprietary protein engineering technology is highly customizable and allows for the generation and screening of large numbers of enzyme variants. Its portfolio of NGS reagents includes enzymes such as novel DNA polymerases, with the potential to improve the performance of the entire sequencing workflow. "This acquisition builds on Roche's commitment to develop a differentiated NGS portfolio that will provide our customers with a complete genetic testing solution," said Mr Roland Diggelmann, COO Roche Diagnostics Division. He added, "Kapa's technology and products complement our current expertise and offerings such as the portfolio of target enrichment products for NGS. We welcome Kapa's employees and are looking forward to strengthening our NGS offerings with this unique technology." Mr Paul McEwan, co-founder and chief scientific officer of Kapa Biosystems, said, "Joining Roche provides us access to their broad product portfolio, global reach and clinical expertise that will accelerate our strategy of offering comprehensive NGS workflow solutions to more laboratories around the world. We are also excited to have the opportunity to further leverage our enzyme engineering capabilities to advance the fields of genomics and sequencing, with the ultimate goal of having a more significant impact on medicine and human health." The transaction is subject to customary closing conditions. Financial terms of the transaction are not disclosed.   ]]> https://biospectrumindia.com/features/97/7827/global-safety-testing-for-biologics-market-to-touch-3-51-bn-in-2020.html https://biospectrumindia.com/features/97/7827/global-safety-testing-for-biologics-market-to-touch-3-51-bn-in-2020.html Wed, 19 Aug 2015 17:03:59 +0530 The global safety testing for biologics market was worth $1.76 billion in 2014 and is projected to reach $3.51 billion in 2020, at a compound annual growth rate of 12.23%. According to market research firm Research and Markets, Pharmaceutical and Biotechnology industries are more concerned over safety of the product, be it in terms of efficacy of the drug, packaging of the product, delivering the product to the customer and others. In all these cases, it is very much important to ensure that the product is safe for the usage. As such, testing place a key role in ensuring the safety of the product. North America leads the global biological safety packaging market with a share of 37.5% in 2014 followed by Europe with 31% of the market share during the same period.   On the other hand, Kits and reagents has a market share of 43% while Instruments has a market share of 20%, based on product type. In emerging countries like India, the government is focusing on increasing the growth of biotechnology industry by investing $5 billion every year for the next 5 years starting from 2015. The growth in the end use industries (Pharmaceutical, Biotechnology) are driving this market. Added to this, factors like new innovations in the Biotechnology industry, new drug developments, increased focus on R&D are increasing the growth of safety testing market. Also, government regulations on the quality of the product are also driving the market. ]]> https://biospectrumindia.com/news/97/6792/unique-mobile-application-on-hiv-aids-launched-by-union-health-ministry.html https://biospectrumindia.com/news/97/6792/unique-mobile-application-on-hiv-aids-launched-by-union-health-ministry.html Wed, 19 Aug 2015 15:35:41 +0530 Mumbai: The Ministry of Health and Family Welfare in collaboration with AIDS Healthcare Foundation, Department of Telecommunications and National AIDS Control Organization announced the launch of a new mobile application on HIV/AIDS today. This mobile application will provide complete information on HIV, increase awareness and risk perception as well as prompt users to access HIV testing from the nearest centre free of cost. Ensuring confidentiality, with bi-lingual facility and easy compatibility, it is expected to reach more than 11 crore people across urban & rural settings. Speaking at the occasion, J.P. Nadda, Union Minister of Health and Family Welfare said that, "Technology and youth are inseparable, however, inadequate access to information and complex messages from various sources can confuse the youth. If we can use technology to guide and educate youth, it can open up endless opportunities to reach the young with authentic information on the services on HIV and AIDS. There is a dire need to motivate, inform and guide them. This mobile application, aptly titled, HIV education and linkage to prevention (HELP), will bridge the gap helping the youth to know their HIV status. It will transmit information personally to each of them which is a step ahead of door to door health services." Navneet S Kang, Additional Secretary and DG, NACO stated that "HIV affects the people most at the productive or young ages. There is a gap between the estimated number of people living with HIV and those who have tested and know their status. It is critical that people know their HIV status early so that a healthy and quality life can be led with the help of treatment. This application will enable the young to assess their risk to HIV and then, take a step forward and get themselves tested. NACO acknowledges the support of AIDS Healthcare Foundation for developing this mobile App for HIV." This new mobile App on HIV will be taken further to the block level by DoT with the help of BSNL & MTNL to cover rural youth across the country. ]]> https://biospectrumindia.com/news/97/6718/fda-approves-siemens-hiv-combo-assay-.html https://biospectrumindia.com/news/97/6718/fda-approves-siemens-hiv-combo-assay-.html Wed, 19 Aug 2015 12:14:34 +0530 This latest addition to the ADVIA Centaur infectious disease menu from Siemens Healthcare Diagnostics, which also includes tests for hepatitis A, B, C; eHIV, syphilis and other infectious disease assays, enables laboratories to further consolidate their testing to enhance efficiencies. The ADVIA Centaur HIV Ag/Ab Combo assay is designed to simultaneously detect the presence of the HIV viral protein (p24 antigen) and the antibodies produced in response to the HIV (HIV-1 or HIV-2) viral infection. The ability to detect both the antigen and the antibody may enable earlier detection of acute infection, allowing both clinical management and behavior modification that may reduce transmission. "Siemens continues to invest in the development of new solutions that allow clinical laboratories to improve both patient care and workflow efficiency," said Mr Franz Walt, CEO, Chemistry, Immunoassay, Automation and Diagnostics IT Business Unit, Siemens Healthcare Diagnostics. He added, "We are proud to offer our U.S. customers a broad range of high performance, fully automated infectious disease tests, which now includes the ADVIA Centaur HIV Ag/Ab combo assay." The ADVIA Centaur HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of both acute and established HIV-1/HIV-2 (including HIV-1 Group O) infection, and has been available for use in Europe since 2010. The third generation HIV test (eHIV) will also remain available on the ADVIA Centaur systems.     ]]> https://biospectrumindia.com/news/97/6549/fda-nod-for-ges-ct-lung-cancer-screening-device.html https://biospectrumindia.com/news/97/6549/fda-nod-for-ges-ct-lung-cancer-screening-device.html Tue, 18 Aug 2015 13:06:42 +0530 GE Healthcare has become the first company with a low dose computed tomography (CT) lung cancer screening option that is cleared by the US FDA (United States Food and Drug Administration) for lung cancer screening. Both the US Preventative Services Task Force (USPSTF) and the Centers for Medicare and Medicaid Services (CMS) recommend the use of low dose CT lung cancer screening for high-risk individuals. Physicians using low dose CT for lung cancer screening will now have access to the benefits from a screening indication, including GE Healthcare's new low-dose screening reference protocols. These new protocols are tailored to the CT system, patient size, and the most current recommendations from a wide range of professional medical and governmental organizations. GE Healthcare CT scanners can be confidently used by physicians within their FDA cleared indications for use, delivering low dose, short scan times, and clear and sharp images for the detection of small lung nodules. These nodules are critical in identifying lung cancer at its earliest stages when it is the most treatable and curable. The landmark National Lung Screening Trial (NLST) was conducted at 33 medical institutions with over 53,000 older, otherwise healthy patients at high-risk due to smoking history. Half of the participants were screened using low dose CT, the other half were screened using chest X-ray. The trial demonstrated that the use of low dose CT screening decisively reduced the mortality rate from lung cancer by 20 percent compared to use of chest X-ray. The NLST also revealed a significant 6.7 percent reduction in the rate of death from any cause using low dose CT screening. "This is the first time in history that any CT device has received FDA clearance for any screening indication," said Mr Henry Hummel, president and CEO of Molecular Imaging and CT at GE Healthcare. He added, "GE Healthcare is thrilled to be the first CT vendor who can help clinicians establish low dose CT lung screening programs in order to continue improving the health of their patients. Healthcare providers are looking for solutions beyond just imaging equipment; we look forward to helping them establish low dose CT lung cancer screening programs that will inevitably save lives through earlier diagnosis and treatment for patients."   ]]> https://biospectrumindia.com/news/97/4434/hyderabad-gears-up-for-camtechs-diabetes-hack-a-thon.html https://biospectrumindia.com/news/97/4434/hyderabad-gears-up-for-camtechs-diabetes-hack-a-thon.html Mon, 17 Aug 2015 17:57:00 +0530 The event is a major platform which calls for all the clinicians, engineers, entrepreneurs, industry experts and end-users to co-create new technologies and business models to transform the prevention, diagnosis and management of diabetes in India. CAMTech works to accelerate medical technology innovation and build entrepreneurial capacity to improve health outcomes in low-and middle-income countries (LMICs). The events kick-off with the 'Diabetes Innovation Clinical Summit: An Ecosystem Approach', a series of panel discussions featuring a diverse group of stakeholders including patients, physicians, nurses, ASHA workers, government and industry representatives and public health experts - focused on tackling pressing clinical health challenges and barriers to diabetes care in India. Prior to the hack-a-thon, CAMTech will host a 'Clinical Summit' and an interactive presentation session called 'Technology Showcase' on the 9th. The day-long Clinical Summit will conclude with the CAMTech Technology Showcase, an interactive presentation of early-stage and newly-marketed diabetes-focused technologies.   The Diabetes Hack-a-thon will take place on 10th & 11th respectively, where teams - through cross-disciplinary collaboration, mentorship and award incentives - will transform ideas into breakthrough innovations that have the potential to shift the paradigm to integrated care management (ICM) and transform diabetic care in India and around the world. India is a home to 65.1 million diabetes patients. By 2035, this value will see a jump to 110 million, according to International Diabetes Federation (IDF) 2014. The total market for diabetes medication in India is valued at Rs 6,000 crore. Globally, India has the second largest diabetes population (67 million) followed by the US at 22.4 million. China occupies the top spot (98.4 million). ]]> https://biospectrumindia.com/news/97/6935/wearable-devices-will-be-crucial-for-healthcare-industry.html https://biospectrumindia.com/news/97/6935/wearable-devices-will-be-crucial-for-healthcare-industry.html Fri, 14 Aug 2015 12:15:55 +0530 New analysis from Frost & Sullivan, Growth Opportunities in the Global Wearable Devices Market, finds that wearable devices will play a large role in the healthcare industry delivering improved healthcare services through real-time, remote patient monitoring and post-surgery rehabilitation. Smart watches and fitness bands are the most popular wearable devices. "Wearable devices will extend beyond fitness tracking to include two-way communication between the user and the healthcare ecosystem," said Frost & Sullivan Information & Communication Technologies Senior Research Analyst Ms Shuba Ramkumar. "Though a number of applications currently address the business-to-consumer market, wearable devices will eventually offer support to healthcare institutions by sharing real-time data collected by the consumer." With embedded sensors continuously collecting data and breaking down context barriers by bringing that data into common social and physical spaces, the implementation of strict privacy and security laws is crucial. Data regulation laws require communication between technology vendors, legal institutions, and governments to determine the future of wearable device data. "In the long-term, energy harvesting and wireless charging technologies will reduce battery issues, helping wearables to capture the interest of consumers. Assuming battery and data accuracy issues are resolved, the real value of wearable devices will accrue as part of the Internet of Things ecosystem, enabling communication of data across devices," said Ms Ramkumar. In terms of the larger picture, pursuing alternative business models will sustain customer interest in wearable devices. Service-based models and enterprise or vertical market partnerships will be especially effective in pushing wearable technology to the mass market, the report said.       ]]> https://biospectrumindia.com/news/97/6635/roche-acquires-geneweave-to-strengthen-offerings-in-microbiology-diagnostics.html https://biospectrumindia.com/news/97/6635/roche-acquires-geneweave-to-strengthen-offerings-in-microbiology-diagnostics.html Fri, 14 Aug 2015 12:15:24 +0530 Roche has announced that it has signed a definitive agreement to acquire GeneWEAVE BioSciences,(GeneWEAVE), a privately held company focused on innovative, clinical microbiology diagnostics solutions based in Los Gatos, CA, USA. Under the terms of the agreement, Roche will pay GeneWEAVE shareholders $190 million upfront and up to $235 million in contingent product related milestones. The transaction is subject to customary closing conditions and, once closed, GeneWEAVE will be integrated into Roche Molecular Diagnostics. The acquisition provides Roche with GeneWEAVE's Smarticles technology, an innovative class of molecular diagnostics that quickly identifies multidrug-resistant organisms (MDROs) and assesses antibiotic susceptibility directly from clinical samples, without the need for traditional enrichment, culture or sample preparation processes. GeneWEAVE's first system in development is the vivoDx-a fully automated, random-access system designed to meet the needs of laboratories addressing MDRO detection and antibiotic therapy guidance. The technology is currently being evaluated in multiple sites across the US. "With GeneWEAVE, we further strengthen our microbiology diagnostics offerings with cutting-edge technology that will aid in the fight against drug-resistant bacteria. This technology has the potential to provide healthcare professionals access to quick and accurate diagnoses that can lead to rapid, informed treatment decisions," said Mr Roland Diggelmann, COO of Roche Diagnostics. He added, "We welcome GeneWEAVE's employees, who will continue to focus on the development and manufacturing of diagnostics solutions based on the Smarticles technology." "We are very excited to continue developing innovative microbiologic diagnostics solutions as part of the Roche Molecular Diagnostics team. Roche is the ideal company to deliver on the promise of our Smarticles technology. We are fully committed to the continued success of GeneWEAVE's employees, products and pipeline," said Mr Steve Tablak, CEO of GeneWEAVE.   ]]> https://biospectrumindia.com/news/97/6223/interpretomics-announces-the-launch-of-hlascape.html https://biospectrumindia.com/news/97/6223/interpretomics-announces-the-launch-of-hlascape.html Fri, 14 Aug 2015 12:14:58 +0530 Bengaluru-based InterpretOmics has announced the launch of 'HLAScape', the country's first Human Leukocyte Antigen (HLA) Typing software solution for organ transplantation and autoimmune disease diagnosis. To commemorate 'Organ Donation day' being celebrated in the country on August 13, InterpretOmics will offer the current version of HLAScape free to academic institutes, public research institutes and public hospitals to make their decision fast and precise for organ transplantation and clinical diagnosis. "Many organ transplants fail due to incorrect HLA typing. HLAScape is a comprehensive software solution for high precision HLA Typing from NGS (Genomics) data for - clinical and transplantation diagnostics. High-resolution HLA Typing is essential in transplantation diagnostics to minimize risk of complexities and improvement of post transplantation graft acceptance", said Dr Asoke Talukder, co-founder and chief scientific officer (CSO), InterpretOmics. He added, "Also, the algorithm accurately identifies the possibility of disease association with the HLA profile of a patient through InterpretOmics curated database called HLABase, which is first in the world." HLAScape can be successfully leveraged to probe HLA associated disease association. It is aimed at precisely identifying all known HLA alleles and also the common HLA alleles across samples. Match profile for donors and patients is constructed based on expressed alleles at HLA markers. "This powerful software developed by InterpretOmics is efficient in identifying all the alleles at high digit resolution, a feature that makes it far superior than any other available software in the market today. Available in On-Premise and Cloud modes, HLAScape ensures accuracy, repeatability and speed of analysis," said Mr Prahalad Achutharao, co-founder and CEO, InterpretOmics.       ]]> https://biospectrumindia.com/news/97/7185/strand-launches-genomic-profiling-service-in-india.html https://biospectrumindia.com/news/97/7185/strand-launches-genomic-profiling-service-in-india.html Thu, 13 Aug 2015 17:05:45 +0530 Strand Life Sciences, a global genomic profiling company that uses next generation sequencing technology to empower personalized cancer care, announced the India launch of StrandAdvantage, a cancer tissue-specific genomic profiling service to provide oncologists with clinically actionable and timely results for first-line therapy decisions. The newly launched service accelerates the analysis of therapeutically actionable cancer genes in solid tumors, and matches them to relevant National Comprehensive Cancer Network (NCCN)-recommended cancer therapies, enabling timely decisions for patient-specific treatments. StrandAdvantage provides oncologists with clinically actionable tissue-specific results for non-small cell lung, breast, and colon carcinomas in a standard-of-care report within 10 working days. Strand's NGS-based genomic profiling service provides a comprehensive view of genomic changes in an easy-to-read report enabling oncologists to make optimized, first-line treatment decisions. The service also provides an extended investigational 'on-demand' report after 15 days for cases that require a complete workup of all major gene variants and pathways known to be impacted by existing targeted therapies.   Mr Scott A Storrer, global CEO and president, said, "StrandAdvantage will provide oncologists with cancer tissue-specific genomic information about their patients' solid tumors and help in guiding first-line therapy decisions. Our genomic profiling service enables the patient to start treatment in days instead of weeks by quickly providing relevant, clinically actionable results. The extended StrandAdvantage report provides an unmatched depth of analysis that includes cancer subtype as well as tissue type." Cancer is a disease affected by multiple variations within genes. Information from single gene tests is often limited and oncologists increasingly want greater depth of information about patients' tumors. StrandAdvantage tests all the relevant genes upfront, thereby helping the oncologist select a targeted therapy for first-line or subsequent treatment. Following the launch of StrandAdvantage, the company announced the appointment of Dr Sudhir Borgonha as SVP and medical director to lead the personalized medicine business in India. Dr Borgonha will be responsible for developing the nascent genomic testing market for oncology and rare diseases.   Dr Borgonha has held senior positions in industry including global medical director at Martindale Pharma and Embrace Innovations, and CEO at Triesta Sciences and Translational Medicine, Inc. Earlier in his career, he worked as a scientist at the Harvard-MIT Clinical Research Centre. He is a graduate of St. John's Medical College, Bangalore and the Sloan School of Management, MIT. ]]> https://biospectrumindia.com/news/97/6248/google-dexcom-to-jointly-work-on-diabetes-management.html https://biospectrumindia.com/news/97/6248/google-dexcom-to-jointly-work-on-diabetes-management.html Wed, 12 Aug 2015 12:00:05 +0530 DexCom, a leader in continuous glucose monitoring (CGM) for people with diabetes, has announced that is has entered into an agreement with the life sciences team at Google to jointly develop a series of next-generation CGM products that are designed to be smaller and less expensive than existing technologies. These new products will incorporate Google's miniaturized electronics platform with DexCom's best-in-class sensor technology. This collaboration also provides an opportunity to better utilize the data generated by these CGM products to significantly improve the outcomes and reduce the costs associated with diabetes care. "This partnership has the potential to change the face of diabetes technology forever," said Mr Kevin Sayer, president and chief executive officer of DexCom. He added, "Working together, we believe we can introduce products that will move us beyond our core Type 1 business to become the standard of care for all people living with diabetes." Mr Andrew Conrad, head of the life sciences team at Google said, "We are committed to developing new technologies that will help move health care from reactive to proactive. This collaboration is another step towards expanding monitoring options and making it easier for people with diabetes to proactively manage their health." Initial products to be developed under the agreement will focus on minimizing both the cost and size of CGM body worn components. The products will be designed to be disposable, and will be intended for use across all diabetes markets. The goal is to empower more people to control their diabetes with real-time and actionable information by developing a low-cost, small, bandage-sized sensor that is connected to the cloud. By addressing these needs, we believe we will have the platform that can replace finger sticks and become the standard of care.   DexCom retains all sales and distribution rights of the products developed under this agreement. DexCom is also obligated to pay an initial upfront payment and milestone payments during development, and revenue-based royalties once these products are launched and have achieved a certain level of revenue.       ]]> https://biospectrumindia.com/news/97/8135/l-day-syngene-shares-soar-superb.html https://biospectrumindia.com/news/97/8135/l-day-syngene-shares-soar-superb.html Tue, 11 Aug 2015 14:11:29 +0530 Shares of Syngene International, a CRO and a subsidiary of biopharmaceutical behemoth Biocon, were listed at Rs 295 today, against its issue price of Rs 250 per share, on the Bombay Stock Exchange (BSE) and National Stock Exchange (NSE). Its shares opened at 18% higher, and hit a high of Rs 315 on BSE, up by 26%. In July 2015, through its Initial Public Offering (IPO), Syngene raised INR 550 crore, and was subscribed more than 32-times. ]]> https://biospectrumindia.com/news/97/7200/cii-submits-recommendations-to-dop.html https://biospectrumindia.com/news/97/7200/cii-submits-recommendations-to-dop.html Tue, 11 Aug 2015 13:12:21 +0530 The Confederation of Indian Industry (CII), has submitted several key recommendations to the Department of Pharmaceuticals (DoP) with regards to the infrastructure support required to boost manufacturing in the medical technology sector in line with the Government's "Make in India" mission. Regarding implementation of the Preferential Market Access (PMA) Policy in medical equipment and device, the industry members recommended promoting the components and ancillary industry without which "Making in India" is not possible in this technology-driven sector. The chairman of CII Medical Technology Department, Mr Himanshu Baid, said "Without the availability of indigenous components, the PMA policy will not yield any results, as already seen in the electronics and IT hardware sector since the last four years. Before the implementation of PMA policy in medical devices and equipment sector, there is a need to properly analyze the components manufacturing capabilities in India." CII has emphasized the importance of recognizing the fact that the manufacturing business case in India is quite challenging. While the labour costs are lower in the country, the capital investment and productivity of the labour are critical limiting factors to the manufacturing business case. Combined with approval delays, this makes the manufacturing environment quite challenging for entrepreneurs. "Access to low-cost capital through soft loans, subsidized land, and assured power and water supply combined with tax incentives and single-window clearance, would certainly build a stronger business case in India," said Mr Pavan Choudary, co-chairman, CII Medical Technology Department.   Some of the recommendations by CII include, Attracting big global medical technology companies to India will help create a base which will then build up the components ecosystem. This, in turn, will enhance local capabilities, enable Indian companies to get access to components and greatly enhance the local manufacturing capability. Establishing medical technology hubs in each zone (north, south, east and west).Manufacturing incentives like tax support and low-cost funding (5% lower rate than the bank lending rates) to spur investments and make the business case attractive. Concessional power tariff in manufacturing hubs. subsidized land prices for setting up medical devices industry in medical technology hubs. Inverted duty structure should be corrected. Customs import duty on raw materials should be lower than finished goods. Four percent Exports Incentives for the sector should be given. According to the industry body, "India is already a large producer of disposables and consumables in India, and export incentives are available for some products. CII has emphasized the need for further capacity building in this segment and focus on quality enhancement for further reduction in imports. The industry needs to get exposed to the learnings of evolving quality standards from countries which have had a head-start in innovations in this space. This will help improve the overall quality standards in India." There are several misconceptions being spread about the medical technology industry amongst stakeholders. Therefore, it is important to build a positive environment which makes a business case and opens doors for investors to start manufacturing in this sector, thus paving the way for the 'Make in India' initiative, said CII.     ]]> https://biospectrumindia.com/news/97/5237/chinese-firm-tencent-invests-in-practo.html https://biospectrumindia.com/news/97/5237/chinese-firm-tencent-invests-in-practo.html Tue, 11 Aug 2015 13:11:52 +0530 Practo has announced that it has received a $90 million investment in a Series C funding round. This round was led by Tencent, with participation from marquee institutional investors including Sofina, Sequoia India, Google Capital, Altimeter Capital, Matrix Partners, Sequoia Capital Global Equities and Yuri Milner. "Our global partners will give us the edge to continue building global healthcare products that our users love. Millions of users trust our platform every month and with our international expansion we aim to take Practo to billions of people globally," said Mr Shashank ND, founder and chief executive officer, Practo. Over the next three to six months Practo will expand product lines and continue to look for potential acquisition of companies to encompass key healthcare segments and provide a seamless experience across medicine, wellness and fitness globally. The company plans to expand its footprints in over 100 Indian cities and 10 countries across South east Asia, Latin America, Middle East and Eastern Europe. "We are excited to partner with Practo as one of our first few investments in India. We look for ambitious, visionary Internet companies that are improving people's lives at a global scale," said Mr Hongwei Chen, senior director of investment and M&A, Tencent.   ]]> https://biospectrumindia.com/news/97/7506/now-an-exclusive-life-sciences-job-portal.html https://biospectrumindia.com/news/97/7506/now-an-exclusive-life-sciences-job-portal.html Fri, 07 Aug 2015 15:32:36 +0530 A new job portal fully dedicated only to Life Sciences professionals will be officially launched and available on August 10, 2015. DNA JOBS, as is called, is a portal whose architecture has been designed to help solve process inefficiency in the recruitment cycle. "This is a centralized platform, and we have mapped the entire life sciences industry into 24 segments, which are further mapped to different companies and employees. Other generic job portals like Naukri, Monster and Times Jobs are into all the industry segments. There are certain existing pain areas for human resource professionals while completing recruiting," commented Mr Ravi Kshirsagar, founder of Inbiosys, a two-year-old start-up which provides project management consulting services to pharmaceutical and biotechnology companies. The job portals is said to be a part of Inbiosys. The portal's algorithm design will try and offer the closest solution to what is being searched by prospective candidates.   It took 7-odd months to develop the portal from conceptualization-to-launch without any external investments backing it up, said the company. According to Mr Kshirsagar, the job portal will considerably reduce the hiring costs and bring down the lead time during hiring process. The portal is expected to cross 30,000 registrations this month. "We are trying to bring research, academia and the industry together in one place," he opined. The idea of launching such a niche job portal stemmed up from his own personal experience, pointed Mr Shirsagar. He remarked, "The launching of the job portal is purely accidental. I started out as a project management consultant, and while I was looking for opportunities I realized it is a major challenge to reach out to the right people in the life sciences industry. Companies, too, are not able to reach out to the right candidates who are hirable." The portal is already tied up with 4 key companies for job postings including Hospira, Stelis Biopharma, Syngene and Theramyt Novobiologics. In the next 30 days after its launch, the portal will have more than 200 job postings, said Mr Kshirsagar. This past July, another similar job portal called BioHiring was launched by a start-up, Clevergene, which again exclusively caters to candidates seeking employment in the pharma, biotech and healthcare space. ]]> https://biospectrumindia.com/news/97/4594/ibm-buys-merge-healthcare-for-1-billion-.html https://biospectrumindia.com/news/97/4594/ibm-buys-merge-healthcare-for-1-billion-.html Fri, 07 Aug 2015 15:08:00 +0530 Tech giant IBM has announced that it would buy medical image company Merge Healthcare for $1 billion to combine with its newly formed health analytics unit. IBM's health analytics unit is powered by famous Watson supercomputer. Through the acquisition, IBM plans to combine data and images from Merge Healthcare's medical imaging management platform with Watson's cloud-based healthcare computing system. Watson has already been working with healthcare leaders such as Memorial Sloan-Kettering and Cleveland Clinic to become a system that LEARNS from analyzing previous situations. The deal will help physicians and researchers collate and analyze data such as patient's medical and family history, data on others with similar symptoms and clinical research, trials and outcomes. "As a proven leader in delivering healthcare solutions for over 20 years, Merge is a tremendous addition to the Watson Health platform," said Mr John Kelly, senior vice president, IBM Research and Solutions Portfolio. Mr Kelly observed, "Healthcare will be one of IBM's biggest growth areas over the next 10 years, which is why we are making a major investment to drive industry transformation and to facilitate a higher quality of care." Watson's powerful cognitive and analytic capabilities, coupled with those from Merge and our other major strategic acquisitions, position IBM to partner with healthcare providers, research institutions, biomedical companies, insurers and other organizations. ]]> https://biospectrumindia.com/news/97/7540/trivitron-launches-two-new-tests-in-the-newborn-screening-panel.html https://biospectrumindia.com/news/97/7540/trivitron-launches-two-new-tests-in-the-newborn-screening-panel.html Fri, 07 Aug 2015 13:53:27 +0530 With an aim to provide newborn babies with corrective diagnosis for birth defects at birth, Chennai headquartered Trivitron Healthcare has added two new products in the Newborn Screening Kit for India. The two new tests are Neonatal IRTand Neonatal Toxoplasma gondii IgM that detect disorders which may harm the newborn in later stages of life. Trivitron is offering a wide range of Newborn screening assays already in the market through the Labsystems diagnostics brand, among those are TSH, PKU, 17OHP, G6PD, Galactose and Toxoplasmi gondii. Together with its fully automated NS2400 platform, Trivitron has launched two new products to complement its newborn screening panel. Trivitron indicates that its Neonatal IRT can detect disorders affecting the lungs, pancreas, intestine and liver. Whereas, Neonatal Toxoplasma gondii IgM can detect neurological and visual disabilities. With the help of these newborn screening tests, it would be possible for parents to take precautions in the early stages of life and prevent the child from life-long disorders. Majority of infants infected in-utero are asymptomatic at birth, particularly if maternal infection occurs during third trimester, with sequel appearing later in life. Congenital toxoplasmosis results in severe generalized or neurological disease in about 20% to 30% of the infants infected in-utero; approximately 10% exhibit visual involvement only and the remainder are asymptomatic at birth. Commenting on the launch of the products, Dr. GSK Velu, Founder and Managing Director of Trivitron Group of companies, said, "Trivitron Healthcare is taking strong steps towards women and child healthcare diagnosis. The thought behind adding two critical tests to the kit is to eradicate detected problems in the newborn at early stages for better lifestyle and to live a carefree life. Trivitron is known for its innovation in medical technology sector and making it available and affordable to larger section of the population across the globe. If untreated during the early stages, problems will start appearing during their teens. Brain and nervous system damage ranges from very mild to severe, and may include seizures and intellectual disability." ]]> https://biospectrumindia.com/news/97/6646/fda-nod-for-samsungs-new-radiography-system-.html https://biospectrumindia.com/news/97/6646/fda-nod-for-samsungs-new-radiography-system-.html Fri, 07 Aug 2015 13:03:16 +0530 NeuroLogica, a subsidiary of Samsung Electronics has announced that the Samsung GC85A Digital Radiography (DR) system has received 510(k) FDA clearance, paving the way for its availability in the US market. The GC85A is the latest expansion of Samsung's growing DR portfolio, which also includes the mobile digital GM60A, the U-arm digital GU60A, and the ceiling digital GC80. Samsung's DR systems combine advanced imaging technology, award-winning design and user-friendly automated workflows to meet the demands of radiology departments. The Samsung GC85A is a ceiling digital X-ray system that offers streamlined workflows, diagnostic confidence and improved total cost of ownership. Other key features include, S-Vue imaging engine that provides dependable and accurate diagnoses in various conditions with reliably clear images, enhanced sharpness and clarity, and adjustable contrast presets, Wireless, lightweight S-Detector with high DQE and a portable grid which displays the patient's body structure clearly and easily without increasing dose. The system also has Smart Control, that enables the operator to precisely position the entire system with one touch of the control panel's buttons. The user can move a motorized, tilting receptor with a remote control from -20 to 90 degrees to various areas such as skulls or hands with no need for a table. "The Samsung GC85A represents NeuroLogica's latest commitment to introducing user and patient-centric innovation to healthcare to provide fast, easy and accurate diagnoses. The system's superior image quality and ease of control will enable users to experience a new level of efficiency with a DR system designed for streamlined operation," said Mr David Webster, vice-president of global sales and chief marketing officer at NeuroLogica.     ]]> https://biospectrumindia.com/features/97/6939/insourcing-it-ops-a-new-trend-in-india.html https://biospectrumindia.com/features/97/6939/insourcing-it-ops-a-new-trend-in-india.html Thu, 06 Aug 2015 17:33:51 +0530 On August 6, 2015, Thermo Fisher Scientific (TFS) inaugurated its first Technology Development Center (TDC) in Bangalore, which will serve as the centre for all of its global IT operations. TFS refused to comment on the investments made in building the center. The TDC will leverage technology platforms like cloud, SAP, J2EE, E1, informatica, testing, web and database. TFS always sought after third-party IT service providers to fulfill its IT needs. It outsourced its IT services to giants including Wipro, Satyam, Deloitte, Cognizant, and Capgemini.   According to Mr Manoj Prasad, VP-IT, TFS India, TDC will be involved in TFS' top 5 projects. The TDC was ran as a pilot since 2012, before being developed as a complete IT operations entity. The newly inaugurated TDC now hosts 180 IT professionals, which is expected to reach a headcount to 250 next year. "There is a big focus on hiring directly from college campuses. We have had great responses from IIT-Madras and IIT-Roorkee. Sixty percent of our hires will be from colleges, and 40 percent from the market with experience," said Mr Amit Chopra, MD, TFS India. Hiring directly from campuses offer companies more leverage on its cost-cutting measures.   By insourcing IT operations, companies gain more control over the development and execution of projects without having to cope with third-parties' time frame. It also offers a peace of mind to companies since data security issues are a major concern when outsourced. TFS is a $17 billion corporation, which has made investments worth $125 million in India in the last 5 years. In the next few years, said the company, it may open similar centers in other Indian cities including Mumbai and Gurgaon. The TDC is expected to double up its capacity in the next 12-24 months, said TFS.   "Availability of skillset, cost, labor and resources in India give us an advantage on cost measures, and enables us to work more efficiently and productively," commented Mr Manoj. On similar lines, in 2014, biopharmaceutical giant AstraZeneca (AZ) insourced its IT operations by opening its Global Technology Centre (GTC) in Chennai worth US $9 million. Till then, IBM served as its IT partner since 2001.   ]]> https://biospectrumindia.com/news/97/6501/illumina-accelerator-invests-in-genomics-startups-.html https://biospectrumindia.com/news/97/6501/illumina-accelerator-invests-in-genomics-startups-.html Thu, 06 Aug 2015 14:04:09 +0530 Illumina has announced that its accelerator, Illumina has selected three new startups for its second funding cycle. Selected from a competitive pool of highly qualified applicants, the new startups from across the globe are spurring genomics innovation in healthcare, agriculture, and the winemaking industry. "We are delighted to invite such a promising group of cutting-edge startups to Illumina Accelerator. Their ability to build innovative solutions to shape the future of genomics inspires us, and we're thrilled to provide them with tools and resources to build a successful future," said Dr Mostafa Ronaghi, senior vice-president and chief technology officer, Illumina. The selected startups for the spring 2015 funding cycle are: • PathoGn, is an infectious disease platform company based in California using genomics and machine learning to build pathogen diagnostics and disease forecasting products for agricultural applications. • Biome Makers, is a microbiome company founded by The Wine Guys, from Castile and Leon, Spain, introducing advanced genomics in the wine sector to transform the quality standards of vinification. • Urology Diagnostics Incorporated is a genomics company from Oregon developing noninvasive urine sequencing diagnostics for screening and monitoring cancer. Each startup will receive seed investment, a subscription to Illumina's NextBio translational genomics database, access to match funding through the $40 million Illumina Accelerator Boost Capital, and Illumina's sequencing systems and reagents. In addition, startups accepted into Illumina Accelerator will gain access to business guidance and fully operational lab space in the San Francisco Bay Area during the six-month funding cycle. "We look forward to building upon the successes of our first graduates-Encoded Genomics, EpiBiome, and Xcell Biosciences, by helping our second group of startups also create significant value, generate terabases of sequencing data, and advance their genomics applications," said Dr Amanda Cashin, who leads Illumina accelerator.   Illumina accelerator strives to catalyze genomics innovation in the broader startup community. Startups are invited to join Illumina accelerator twice a year.     ]]> https://biospectrumindia.com/news/97/5292/fda-approves-worlds-first-3d-printed-pill.html https://biospectrumindia.com/news/97/5292/fda-approves-worlds-first-3d-printed-pill.html Thu, 06 Aug 2015 13:59:00 +0530 Its not just organs anymore, even your pill might be printing! The US FDA has given its nod for the world's first 3D-printed pill produced by Ohio-based pharmaceutical company Aprecia. The drug, Spritam levetiracetam, is a new drug to control seizures brought on by epilepsy. Aprecia said that through its 3D printing platform-ZipDose, it planned to develop other medications for various indications. This technology makes high-dose medications easier to swallow. The company further said in a statemnet that 3D printing allows a high drug load - up to 1,000 mg - to be delivered in a single dose. The 3-D printing process creates a pill that has "a porous formulation that rapidly disintegrates with a sip of liquid." Doctors are already using customized, 3-D printing to create implants for patients with injuries and are exploring a wide range of other applications, such as printing human tissue and even whole organs.   ]]> https://biospectrumindia.com/news/97/4130/abbott-expands-its-cardiac-therapies-business-.html https://biospectrumindia.com/news/97/4130/abbott-expands-its-cardiac-therapies-business-.html Thu, 06 Aug 2015 11:38:43 +0530 Abbott has announced that it has entered into an agreement to purchase Tendyne Holdings, a private medical device company focused on developing minimally invasive mitral valve replacement therapies. Under the terms of the agreement, Abbott will acquire the equity of Tendyne that it does not already own for $225 million upfront, resulting in a total transaction value of $250 million, plus potential future payments tied to regulatory milestones. Tendyne's Bioprosthetic Mitral Valve System is an investigational device and not currently available for sale. The US Food and Drug Administration (US FDA) has provided approval for a feasibility clinical trial to provide data about the device's safety and effectiveness. The trial has begun enrolling patients, and there are plans to begin enrollment next year in a clinical trial to support CE Mark in Europe. In a separate transaction, Abbott has provided capital and secured an option to purchase Cephea Valve Technologies. Cephea Valve Technologies, a private company, is developing a catheter-based mitral valve replacement therapy. Financial terms were not disclosed. As part of its structural heart portfolio, Abbott currently offers MitraClip, a first-of-its-kind mitral valve repair device used to treat certain types of mitral valve disease, the most prevalent heart valve disease.1 It is delivered to the heart via a catheter through the femoral vein, a blood vessel in the thigh. MitraClip is available in the United States, Canada, Europe and countries in Asia and Latin America. More than 25,000 people around the world have been treated with the MitraClip device. The Tendyne and Cephea valve replacement technologies are designed to be implanted in a beating heart, without the need for open heart surgery, similar to MitraClip, thereby offering a new treatment option. Minimally invasive mitral valve repair and replacement is expected to become a multi-billion dollar market over the next 10 years.   "Mitral valve disease is highly complex and requires multiple treatment options in order to tailor the therapy based on each person's anatomy and health situation," said Dr John M Capek, executive vice-president, Ventures, Abbott. He added, "The Tendyne acquisition and our agreement with Cephea broaden our foundation as one of the leaders in treatments for mitral valve disease, with the goal of bringing promising, less invasive valve treatment technologies to people who need them."   ]]> https://biospectrumindia.com/news/97/7474/illumina-to-acquire-genologics.html https://biospectrumindia.com/news/97/7474/illumina-to-acquire-genologics.html Wed, 05 Aug 2015 11:43:49 +0530 Illumina has announced it has signed a definitive agreement to acquire GenoLogics Life Sciences Software, a developer of information management systems (LIMS) for lifesciences organizations. "The acquisition of GenoLogics demonstrates Illumina's commitment to drive the adoption of sequencing in new markets and improve the genomic information workflow. Adding GenoLogics' products to Illumina's portfolio is another example of our continued commitment to bring innovative sample-to-answer solutions to research and clinical labs," said Mr Francis deSouza, president of Illumina. Adopted by over 120 genomic labs worldwide, GenoLogics' Clarity LIMS software enables lab efficiencies and improved sample throughput with increased accuracy, fast turnaround, sample traceability, and preconfigured instrument integrations. GenoLogics has a number of current partnerships with Illumina, including the recently launched Clarity LIMS X, an edition of its laboratory informatics platform that is optimized for use with Illumina SeqLab to address population-scale genomics workflows. "We are excited to join Illumina and carry on the innovative spirit that GenoLogics Life Sciences Software has been known for," said Mr Michael Ball, CEO of GenoLogics. He added, "Illumina and GenoLogics have had a longstanding partnership and this acquisition will enable us to widen our distribution, accelerate our product development, and provide even greater support to the Clarity LIMS community." The impact of this transaction was contemplated in the updated 2015 financial guidance Illumina provided on July 21, 2015. The acquisition is expected to close by the end of August.   ]]> https://biospectrumindia.com/news/97/7191/astrazeneca-partners-with-isis-pharmaceuticals-.html https://biospectrumindia.com/news/97/7191/astrazeneca-partners-with-isis-pharmaceuticals-.html Tue, 04 Aug 2015 11:36:35 +0530 AstraZeneca and Isis Pharmaceuticals has announced a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases. The new collaboration builds on a broad existing relationship between the two companies and supports AstraZeneca's strategic approach in these therapeutic areas using novel RNA-targeted treatments. It also enables Isis Pharmaceuticals to extend use of its antisense technology to diseases of the kidney. Antisense drugs are short, chemically-modified, single-stranded nucleic acids (antisense oligonucleotides) that have the ability to target any gene product of interest. AstraZeneca will pay an upfront fee of $65 million to Isis Pharmaceuticals plus development and regulatory milestones for each programme that AstraZeneca advances to clinical development. Isis Pharmaceuticals is also eligible to earn tiered double-digit royalties on annual net sales for each programme. Dr Mene Pangalos, executive vice-president, Innovative Medicines and Early Development at AstraZeneca, said, "Antisense-based therapies are rapidly gaining momentum in the clinic and becoming an important component of our early stage pipeline. This collaboration combines the world-class antisense drug research capabilities of Isis with our expertise in cardiovascular, metabolic and renal disease drug discovery and development. By working together we aim to uncover targets and pathways that can be manipulated using antisense drug therapy." Dr B Lynne Parshall, COO at Isis Pharmaceuticals, said, "This expansion of our collaboration with AstraZeneca establishes our second strategic relationship. This new collaboration will help broaden the application of our antisense technology to targets in the kidney. AstraZeneca is committed to finding novel best-in-class therapies for some of the largest, most complex and fastest growing disease segments in the developed world. Combining our antisense technology with AstraZeneca's strong knowledge, leadership and commitment in these areas should be very valuable in fully exploiting these opportunities and moving new therapies effectively and efficiently toward the market."   This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.   ]]> https://biospectrumindia.com/news/97/6938/allow-medtech-sector-to-work-with-doctors-cii.html https://biospectrumindia.com/news/97/6938/allow-medtech-sector-to-work-with-doctors-cii.html Tue, 04 Aug 2015 11:19:31 +0530 CII Medical Technology Division (CII-MTD) participated in a meeting organized by the Department of Pharmaceuticals under the chairmanship of Hon'ble Minister of Chemicals & Fertilizers, Mr Anant Kumar to discuss the Universal Code for Pharmaceutical marketing Practices (UCPMP). CII representation, lead by Mr Himanshu Baid, chairman of CII-MTD and Mr Pavan Choudary, co-chair of CII-MTD, focused on the fact that Medical Device Industry is an innovation driven industry and needs to work with medical practitioners as well as paramedical professional in close proximity and therefore, provision of current UCPMP not allowing industry to engage medical practitioner for continued medical education on latest technologies may be detrimental to the medical device industry. "Medical Devices have a short product life cycle (18 to 24 months) and have frequently upgraded versions. Every new product which comes into market requires physicians to undergo sufficient trainings. The proposed code shouldn't constraint Industry's ability to provide no-frills training to Medical Practitioners," said Mr Himanshu Baid. CII-MTD recommended that the code should be appropriate for medical device companies and industry practices, which are significantly different from pharma industry. "The code in its current form needs more discussion and clarity on research grants or other support funds be regulated by this code as well as product donation, which is needed and is not recognized and hence no provision made for allowing this type of donations as long as desired documentation is maintained by companies," said Mr Pavan Choudary. "CII-MTD recommends a distinct marketing practices code for Medical Device Industry, which supports Training, Education and Awareness Programs that improve patient outcome and would be pleased to work with Department of Pharmaceuticals in developing an appropriate "Universal Code for Medical Device Marketing Practices (UCMMP)," said Mr Baid.   ]]> https://biospectrumindia.com/news/97/7296/godrej-appliances-forayed-into-healthcare-space-by-manufacturing-medical-refrigeration-with-transferred-technology.html https://biospectrumindia.com/news/97/7296/godrej-appliances-forayed-into-healthcare-space-by-manufacturing-medical-refrigeration-with-transferred-technology.html Mon, 03 Aug 2015 17:23:28 +0530 By Libin Chacko Kurian Godrej Appliances, one of the leading players in the Home Appliances industry, in partnership with The UK based The Sure Chill Company, has launched the 'Godrej medical refrigerators with Sure Chill technology'. The specialised medical refrigerators have been designed especially to address a key need of providing precise cooling for preserving vaccines used worldwide in immunization programs and for the storage of blood in blood banks. With manufacturing the appliances, the venture claims to support Make in India campaign, as Godrej Appliances becomes the only company which manufacture medical refrigeration in India and will also be exporting to more than 75 countries in near future. The manufacturing facilities in Mumbai and Pune have the capacity to produce 10,000 appliances annually, which will be upgraded to 30,000 soon. The company is in talks with the Nepal government to provide more than 100 such refrigerators for disaster relief in that country. The company have already installed 13 refrigerators for medicinal purposes in West Bengal and is working since September 2014. 50 more refrigerators will be installed in four more states namely, Jharkhand, Uttar Pradesh, Uttarakhand and Meghalaya soon. Godrej appliances have the largest network with more than 500 service centres reaching every district in the country. The company is releasing an investment of 35 crores in three phases for the manufacturing of medical refrigeration, of which first phase is already in process. Sure Chill's technology helps to maintain the optimum temperature range of 2 - 8 degrees Celsius - a necessity for vaccine preservation and blood storage. This refrigerator maintains its temperature even in case of power outages for as long as 8-12 days in ambient temperatures of 43ËšC. In regions without electric supply, the system can be teamed with solar power to deliver the same results, thereby, making it fit for global immunisation needs. Godrej, making its first foray into the healthcare sector, has signed a technology transfer agreement with The Sure Chill Company Ltd. (UK) to develop & manufacture these refrigerators for sale in India and neighbouring markets covering SAARC and MENA countries including Pakistan, Bangladesh, Bhutan, Nepal, Saudi Arabia, UAE among others. The partnership between the two companies brings together Godrej's decades of expertise in refrigeration technology and Sure Chill's in-depth technical expertise in medical refrigeration, to create an innovative product that is expected to help governments across the world in their immunization efforts to save millions of lives. Kamal Nandi, Business Head and EVP, Godrej Appliances, said, "Godrej Appliances has built its expertise in refrigeration over the years. The brand is synonymous with trust and is therefore, best placed to enter a category like medical refrigeration, which delivers critical care. In line with our commitment to a greener planet, we are proud to state that the Godrej medical refrigerators are the world's 1st and only green ILR's currently available." "Leveraging our core capabilities in the cooling space and our deep understanding of Indian conditions, we have been able to increase the holdover time of the vaccine refrigerators by 30%. We have introduced built in voltage stabilizer and spike guard to take care of voltage fluctuations common to developing countries and also ensured superior performance of the vaccine refrigerator by building in an early intelligent warning system. Our 57 years of existence in the cooling industry coupled with an extensive service network in the country positions us to deliver quick and reliable service to this critical healthcare business," he added. Godrej Sure Chill will be available in two model variants, 100 liters- priced between Rs 1.35 lakh to Rs 1.5 lakhs, and 50 liters-priced between Rs. 65,000 to Rs.75,000. These medical refrigerators meet strict specifications laid down by WHO and are listed as PQS prequalified. Though the new product is expensive than that of the existing technology, the overall expense is calculated to go down with low wastage and effective cold chain management. The technologyThe Sure Chill Company has developed a completely new approach to refrigeration that radically improves performance and can operate without constant power for days and weeks. Sure Chill technology is based on the scientific principle that water is at its heaviest at 4°C, which happens also to be the ideal temperature for storing vaccines, fresh food and beverages. The technology harnesses this natural phenomenon to create a constantly chilled environment within the refrigeration unit - whether there is power or not. It is so reliable that it will maintain a completely steady temperature for 10 days or more after power has been interrupted. This is achieved through the movement of dense water at 4°C, generated as the system's ice bank interacts with warmer water circulating within the unit. Once power has been used to generate the ice bank in the first instance, the Sure Chill technology channels the supply of naturally generated 4°C water to the refrigeration compartment without the need for any further power. This process can continue until the ice bank, the ultimate generator of the dense water, finally melts and needs to be refrozen, which can take as little as two hours. In effect, the Sure Chill system creates a natural and internal energy store that is capable of providing a perfect, constantly chilled storage environment in areas where there is an intermittent power supply. And if there is no power at all, as if often the case in regions where vaccines are most needed, then the system can be teamed with solar power with exactly the same results. Vaccines are temperature-sensitive and must be stored at the correct temperature. They are irreversibly damaged by exposure to heat or freezing within the cold chain delivery system and once damaged they are less effective and do not protect fully from disease. Some reports say that this occurs in over 70% of vaccine shipments worldwide. Sure Chill's technology solves this problem by providing constant reliable cooling without the need for continuous power. It is already saving lives. Immunization Programme Immunization is one of the most basic and effective health interventions. Unfortunately, one in five children is still deprived of these basic defenses for the most prevalent diseases, particularly in developing countries. Large populations and fragile infrastructures make these children difficult to reach. Many developing countries have inadequate 'cold chains' - which means that optimal temperature control mechanisms for the transport, storage and handling of vaccines are not in place. According to a research estimate, approximately 151 million vaccines, equivalent to approximately$750 million, are lost annually due to improper refrigeration in developing countries. ]]> https://biospectrumindia.com/features/97/6950/global-orthopedic-braces-supports-market-value-to-approach-3-5-bn-by-2021.html https://biospectrumindia.com/features/97/6950/global-orthopedic-braces-supports-market-value-to-approach-3-5-bn-by-2021.html Mon, 03 Aug 2015 13:19:04 +0530 The global orthopedic braces and supports (orthotics) market will rise in value from $2.56 billion in 2014 to reach just under $3.5 billion by 2021, largely driven by an aging population and patient preference for braces and supports as non-invasive treatment options, says research and consulting firm GlobalData. The company's latest report states that this increase, which will occur across the 10 major markets of the US, France, Germany, Italy, Spain, the UK, Japan, India, China, and Brazil, represents a moderate Compound Annual Growth Rate (CAGR) of 4.6%. The US will continue to dominate the orthotics space, retaining over 50% of the market share throughout the forecast period. According to Ms Jennifer Ryan, GlobalData's analyst covering medical devices, the expanding utilization of braces and supports reflects the growing proportion of the population likely to benefit from their use, namely post-operative patients and the elderly. Ms Ryan says: "Braces are increasingly being adopted worldwide thanks to their dynamic therapeutic approach, especially in fracture treatment and post-operative rehabilitation. While the market is dominated by knee braces, upper extremity braces are expected to grow at the fastest rate during the forecast period, at a CAGR of 5.1%. "However, developing countries with little to no reimbursement for patients requiring expensive custom devices will restrict market growth."   The analyst adds that as the number of indications for which braces are employed expands, manufacturers are taking advantage and broadening their product portfolios to include devices tailored to specific indications. Ms Ryan continues: "While the global orthotics market is fragmented and composed of many smaller players, major companies that have made a name for themselves do hold large shares in this space courtesy of their known and trusted brands. These include DJO, Bauerfeind, Breg, Ossur, and Ottobock. "Smaller manufacturers tend to be most successful in developing markets, where it is cheaper to use local products rather than import branded devices." However, key opinion leaders interviewed by GlobalData noted that there is a lack of brand loyalty in orthotics, as physicians require access to as many different options as possible to meet a diverse range of patient needs, indicating that opportunities remain for new players to enter this therapy area. ]]> https://biospectrumindia.com/news/97/6683/ge-healthcare-launches-wear-your-health-challenge-.html https://biospectrumindia.com/news/97/6683/ge-healthcare-launches-wear-your-health-challenge-.html Mon, 03 Aug 2015 12:12:37 +0530 Ochsner Health System, GE Healthcare and The Idea Village have launched the "Wear Your Health" challenge. This challenge seeks to identify wearable technology concepts and mobile application solutions that can transform healthcare outcomes by addressing behavior management in patients with chronic disease.  The "Wear Your Health" challenge seeks to engage entrepreneurs and innovators across the US, to think about the best ways to address the evolving needs of healthcare, encourage lifestyle modifications, and help impact individual health. "Chronic disease is a particularly serious health and community concern in Louisiana, which is ranked fifth in the nation for the highest rates of diabetes and heart disease, and fourth in the nation for the highest rates of cancer and high blood pressure," said Dr Richard Milani, chief clinical transformation officer at Ochsner Health System. He added, "This challenge aligns with our work underway today through innovationOchsner or iO to identify the behaviors that drive improved wellness and empower patients to take control of their health. The ideas generated through this challenge can provide new solutions to address these issues in our community but also extend these findings to patients across the US." Phase 1 of the challenge, will identify up to 10 winners for a cumulative prize pool of $10,000. The winners of Phase 1 will then be eligible to participate in Phase 2, where 3 finalists will receive additional development funding from a discretionary prize pool of $15,000. The overall winner will be announced at New Orleans Entrepreneur Week, March 11-18, 2016. "In recent years, wearables have been disrupting the healthcare industry. The ability to manage patient behavior through wearables ultimately allows for a more personalized patient experience and treatment plan," said Mr Brad Jergenson, chief marketing officer, USA and Canada at GE Healthcare. He added, "The 'Wear Your Health' challenge is a great opportunity to bring not only prototypes, but ideas, to life. The goal is to drive the future of chronic disease management by empowering patients to lead healthy lifestyles through connectivity and technology, which aligns with GE Healthcare's overall mission to provide quality, accessible, and affordable healthcare to all." More information on the challenge and requirements for submission can be found on innovationochsner.com.     ]]> https://biospectrumindia.com/news/97/6498/ge-healthcare-to-invest-1-billion-in-training-health-professionals.html https://biospectrumindia.com/news/97/6498/ge-healthcare-to-invest-1-billion-in-training-health-professionals.html Mon, 03 Aug 2015 11:42:39 +0530 GE Healthcare has announced a plan to invest more than $1 billion over five years in the development of its educational offerings to reach more than two million healthcare professionals worldwide by 2020, helping them improve healthcare from within through enhanced training programs and solutions for physicians, radiologists, technologists, midwives, nurses, biomedical engineers and beyond. Solutions will be geared to meet local needs and will include new clinical, product application, technical and leadership training and education. "Challenges around localized capacity building, training and innovation are consistent themes for many healthcare systems and Ministries of Health around the world," said Mr John Flannery, president and CEO, GE Healthcare. He added, "We will continue to work closely with local governments, institutions and customers to address some of their most important concerns. In some countries, this will mean training midwives to use new ultrasound or portable diagnostic equipment. In others, it will include supporting multi-hospital networks to enhance their clinical and operational outcomes." As part of this training commitment, GE Healthcare will continue to work with healthcare providers to build strategic programs that may also include technology, finance and consultancy services to help improve healthcare delivery and drive transformational change in the industry. "Our focus is to develop meaningful, relevant education solutions that will help healthcare professionals create long-term value and positive measurable impact. By combining our heritage in medical technology, healthcare IT, software and life sciences, we can provide enhanced learning, insights and best practices that can make a real difference," said Mr Mario Lois, general manager, Global Education Services at GE Healthcare. GE Healthcare will provide on-the-ground, online and remote training mostly as part of a commercial partnership with customers to help optimize health providers' skills for real life clinical situations.   This program builds on GE Healthcare's existing global training initiatives like Skill India Initiative, developed by GE Healthcare, brings together healthcare and education experts to train and educate more than 100,000 new and existing healthcare professionals in India over the next five years. GE Foundation has worked alongside local Ministries of Health for more than a decade through its Developing Health Globally initiative.   ]]> https://biospectrumindia.com/news/97/7301/tataa-biocenter-to-distribute-strand-ngs-in-europe.html https://biospectrumindia.com/news/97/7301/tataa-biocenter-to-distribute-strand-ngs-in-europe.html Fri, 31 Jul 2015 13:45:36 +0530 TATAA Biocenter, organizer of hands-on training in molecular diagnostics and Europe's leading provider of genomic services, has partnered with Strand Life Sciences, which implements bioinformatics in personalized medicine, to advance the analysis of Next Generation Sequencing (NGS) data. As part of the partnership, TATAA Biocenter will distribute and support Strand NGS, Strand's premier analysis tool for NGS data, in Europe. "We always seek collaboration with the best solution providers for our training courses and Strand Life Sciences are top of the class for NGS whole transcriptome profiling," says Ms Kristina Lind, coordinator of TATAA Biocenter's hands-on training program. "Our customers request professional tools for the entire NGS workflow from sample preparation, quality control, library preparation, sequencing and data analysis," says Mr Mikael Kubista, president of TATAA Biocenter. "With Strand NGS our customers obtain the most comprehensive and powerful tool for the analysis of Next Generation Sequencing data". "We have always welcomed collaborations for serving the customer better and for the greater good of science. Tataa Biocenter is an established player in Europe with a wide reach. European customers will now have access to one of the most comprehensive, commercially available, NGS analysis tools" says Mr Scott Storrer, President of Strand Life Science. ]]> https://biospectrumindia.com/news/97/6412/take-solutions-creates-a-new-us-subsidiary.html https://biospectrumindia.com/news/97/6412/take-solutions-creates-a-new-us-subsidiary.html Fri, 31 Jul 2015 10:21:53 +0530 TAKE Solutions Ltd., Chennai headquartered business technology solutions provider, has announced its foray into the big data market for the Life Sciences sector, by setting up 'Intelent' - its new US-based subsidiary, with an initial investment of $3 million. Intelent aims to address the $300 billion healthcare and life sciences market (according to projections by McKinsey) by providing clients offerings in the areas of data integration and advanced analytics. Noting the exponential growth in data volume and variety, and shortening of technology lifecycles, TAKE has set up Intelent to address the challenge of harnessing data from multiple streams to create a competitive advantage for its clients. This investment is expected to help organizations mine their mountain of data to fulfill business and operational needs along with compliance to reduce risk, accelerate timelines and boost returns. Born out of TAKE's strong business domain and technology expertise in strategy and implementation, Intelent will provide organizations a platform for integrating and analyzing data and deriving actionable intelligence. Commenting on the subsidiary in US, Mr. Srinivasan HR, Vice Chairman & Managing Director, TAKE Solutions said, "As domain experts in life sciences, we have understood the specific impact of this trend in business life cycles. There has been a growing importance of mining actionable insights from Big Data for strategic decision making in the life sciences space. This investment goes into areas of analytical data aggregation, mining and visualization. Insights and intelligence derived from fast-moving data sets can help inform strategy decisions, spur innovation, inspire new products, enhance customer relationships and bolster operations." ]]> https://biospectrumindia.com/news/97/3411/siemens-healthcare-reveals-new-diagnostic-products-.html https://biospectrumindia.com/news/97/3411/siemens-healthcare-reveals-new-diagnostic-products-.html Wed, 29 Jul 2015 10:55:16 +0530 Siemens Healthcare Diagnostics reveals its latest in-vitro diagnostic solutions-including the recently FDA-cleared ADVIA Centaur XPT Immunoassay System at the 2015, AACC Annual Meeting and Clinical Lab Expo, Atlanta, July 26-30. In addition to featuring its portfolio of multidisciplinary solutions designed for use in hospital, reference, and physician office laboratories and near patients' bedsides, the booth will highlight how Siemens' customers around the world are achieving their clinical and workflow goals. "Customers need a reliable partner who can help them achieve higher levels of operational efficiency while providing quality results that lead to optimal patient care. The solutions we are showcasing at this year's AACC can help customers successfully achieve their workflow and clinical goals, regardless of the size of their operations or testing demands," said Mr Michael Reitermann, CEO, Siemens Healthcare Diagnostics. One such example, the ADVIA Centaur XPT Immunoassay System, is a high-throughput analyzer that enhances workflow to meet the demands for reliable and rapid immunoassay testing. Recently FDA-cleared, this analyzer is designed to provide simple, continuous operation; accurate, timely results; and powerful, seamless connectivity including to Aptio Automation, the company's flexible, track-based automation system. Aptio Automation's connectivity options include the ADVIA Chemistry XPT System, Siemens' newest high throughput chemistry analyzer, and the Sysmex CS-5100 System, a high-volume hemostasis analyzer. Also the company showcased the Sysmex CS-2100i System, a mid-volume benchtop hemostasis analyzer. Both the Sysmex CS-2100i System and Sysmex CS 5100 System are currently under FDA review and utilize simultaneous multi wavelength detection and first-to-market PSI technology to manage unsuitable coagulation samples (e.g., improperly filled sample tubes) for high-quality accurate results.   Another new hemostasis offering on display-one for point-of-care testing-is the Xprecia Stride Coagulation Analyzer. Winner of the prestigious Red Dot design award, this handheld coagulation system is designed to perform prothrombin time testing (PT/INR). The CLINITEK AUWi PRO Automated Urinalysis System is a true walkaway solution for integrated urinalysis testing. It combines a urine chemistry analyzer (CLINITEK Novus Automated Urine Chemistry Analyzer) with a urine sediment analyzer (Sysmex UF-1000i Automated Urine Particle Analyzer). New infectious disease assays include the ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay, which allows for sensitive and specific detection of HIV p24 antigen and antibodies and may improve detection of early acute infections. The ADVIA Centaur Syphilis assay is used as an aid in the disease's diagnosis. This assay allows for sensitive and specific detection of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, sodium citrate). Another innovative offering making its debut at AACC is Siemens PEPconnect, part of the total Personalized Education Plan (PEP), the industry's first personalized education and performance experience for the healthcare professional.     ]]> https://biospectrumindia.com/news/97/7242/vodafone-powers-diabetacares-wireless-glucometer.html https://biospectrumindia.com/news/97/7242/vodafone-powers-diabetacares-wireless-glucometer.html Tue, 28 Jul 2015 12:20:56 +0530 Vodafone Business Services (VBS), the enterprise arm of Vodafone India, has collaborated with Diabetacare to launch dCare Smart, a device that helps people manage diabetes better. dCare Smart, is a GSM SIM enabled wireless glucometer that empowers people to proactively monitor their blood sugar levels which is powered by Vodafone's Machine to Machine (M2M) embedded cellular technology. The device transmits blood sugar results to a secure Diabetacare server, where they are constantly monitored by Diabetes Specialist Clinicians at the Diabetacare`s Diabetes Management Centre (DMC). In case of any abnormal blood glucose readings, both the patient and kin receive an alert/call with expert advice from the DMC immediately. dCare Smart is powered by Vodafone's Machine to Machine (M2M) embedded cellular technology. It is paired with the back-end clinical servers which connect directly to the electronic medical record system, wherein access is given to patients and their caregivers to keep them informed and better manage the condition. Mr Nick Gliddon, director, Vodafone Business Services said, "Vodafone is renowned globally for being a leader in M2M solutions and is driving the Internet of Things (IoT) by connecting machines, devices and objects to the internet, turning them into 'intelligent' assets that communicate with the world around them globally for more than 20 years. Leveraging our global expertise, we are the first telecom service provider to offer the M2M service platform in the Indian market today. Vodafone's M2M Solution for Diabetacare allows data to be securely uploaded to a central server and is then accessed remotely by multiple parties." Dr Sanjiv Agarwal, founder and MD, Diabetacare said, "We looked at alternatives but, for me, Vodafone's M2M solution is ahead of the game. Beyond the technology, Vodafone was able to demonstrate a real problem-solving attitude. Vodafone's global M2M solutions will help Diabetacare fulfil its plans to ramp up deployments to 100,000 users across multiple locations. Diabetacare is a mainstream proposition and the service is priced to make it affordable. Vodafone's scale and global coverage means the business needs just one supplier, fully managed from a single platform. It means Diabetacare is ready to respond quickly to growth opportunities worldwide."       ]]> https://biospectrumindia.com/features/97/6877/global-bioabsorbable-scaffolds-market-to-rocket-beyond-2-bn-by-2021.html https://biospectrumindia.com/features/97/6877/global-bioabsorbable-scaffolds-market-to-rocket-beyond-2-bn-by-2021.html Mon, 27 Jul 2015 15:29:45 +0530 The global market value for bioabsorbable scaffolds (BAS) will expand rapidly from $143.7 million in 2014 to just under $2.1 billion by 2021, driven primarily by new product approvals and a paradigm shift in the clinical treatment of vascular diseases towards minimally-invasive procedures, according to research and consulting firm GlobalData. Mr Amen Sanghera, GlobalData's analyst covering medical devices, says that while BAS devices have yet to gain regulatory approval in the US, China and Japan, there are already four CE-Marked BAS devices approved in the five European countries (5EU). Mr Sanghera comments: "Abbott Vascular is the primary player in this market with its drug-eluting BAS, Absorb BVS, which is available across the 5EU and in selected Latin-American and Asian countries. The product is expected to gain USFDA approval by 2016. "Abbott Vascular recently gained the CE Mark for a package incorporating both Absorb BVS and the company's state-of-the-art catheter delivery system, the GlideTrack. This package is expected to increase the uptake of the Absorb BVS system, as it addresses clinical concerns surrounding the delivery of its device to occluded coronary vessels." With sufficient improvements, it is anticipated that BAS could begin to challenge drug-eluting stents as the gold standard of coronary and peripheral artery disease stenting, as BAS devices aim to directly confront the current issues with permanent metallic stents, such as late in-stent restenosis, vessel scarring and late stent thrombosis.   Mr Sanghera continues: "Technological trends in the market are aimed at reducing the thickness of BAS and providing better delivery systems, more efficient drug-elution characteristics, and faster resorption times. "As long-term clinical data demonstrating their efficacy become available, the uptake of BAS will gradually increase across the 10MM. The expanding presence of BAS products, along with a reduction in their prices, will drive substantial growth during the forecast period," the analyst concludes.   ]]> https://biospectrumindia.com/news/97/7203/usibc-concludes-medical-device-trade-mission-to-india.html https://biospectrumindia.com/news/97/7203/usibc-concludes-medical-device-trade-mission-to-india.html Mon, 27 Jul 2015 13:54:57 +0530 The US-India Business Council (USIBC) concluded its Medical Device Trade Mission to New Delhi and Gandhinagar. The delegation expressed its commitment to addressing India's most pressing public health challenges, and called for further dialogue with the government on issues related to ease of doing business, disease management, and the implementation of training programs for medical device regulators. The delegation encouraged the government to pass legislation that would provide specific regulations for medical devices, which are currently treated as pharmaceuticals under India's Drug & Cosmetics Act. The industry is also working to engage with the government and stakeholders to partner on solutions for increased access to medical technology for Indian patients. The delegation was chaired by Mr Maulik Nanavaty, senior vice-president and president for Neuromodulation at Boston Scientific, and included participation from Abbott, Medtronic, Zimmer, Johnson & Johnson, Quintiles, General Electric, Varian Medical, and AZB & Partners. "Through this series of fruitful discussions, we have identified opportunities to continue collaborating with the Government of India in support of its priorities to attract investment and talent to the medical device sector. India has made considerable strides in developing innovative industries across a number of sectors and maintains strong potential to do the same in medical devices," said Mr Maulik Nanavaty of Boston Scientific. He added, "With India's first-rate engineering talent, experience in IT innovation, and the Modi government's Make in India focus, it is even more important for the government and industry to work toward creating the proper ecosystem for medical device innovation. This will expedite the ongoing creation of research and development and product innovation that medical device companies offer India, leading to faster growth of medical device manufacturing in the country. The time is opportune to fulfill the government's mandate of Make in India and Innovate in India."   Over the course of the mission, the delegation met with a wide range of public and private sector representatives to convey the global medical device industry's long-term commitment to working with the Indian Government and key stakeholders. Meetings with the Government of India included the Ministry of Health, Department of Industrial Policy and Promotion, Drugs Controller General of India, Ministry of Commerce, Ministry of Finance, Department of Pharmaceuticals, and the Ministry of Chemicals and Fertilizers. "USIBC member companies were encouraged by the openness of the Government of India to engage with industry on best practices and areas of potential collaboration. Discussions included the importance of developing a critical mass of patients with access to healthcare and improving patient awareness of healthcare costs," said Ms Amy Hariani, director and legal policy council at the USIBC. The Indian medical device industry is currently valued at $4.4 billion. According to USIBC, the sector has the potential to grow to $7 billion by 2016, with a growth rate of 10-15 percent annually.   ]]> https://biospectrumindia.com/news/97/6920/medgenome-raises-20-million-from-sequoia-capital.html https://biospectrumindia.com/news/97/6920/medgenome-raises-20-million-from-sequoia-capital.html Fri, 24 Jul 2015 12:31:41 +0530 MedGenome has announced that it has received a $20 million investment from Sequoia Capital in a Series B funding round. With this funding, the company will further invest in building its cutting-edge bioinformatics infrastructure, enhance its sequencing facilities in India and the US, and expand its research and scientific teams. "In the past year, the value chain of drug discovery has increasingly moved towards genomics and next-generation sequencing, with enormous market potential," said Mr Abhay Pandey, managing director at Sequoia Capital. He added, "The value of MedGenome's Indian genetic dataset is unprecedented, and as the genomics space undergoes rapid scale transformation and expansion, MedGenome has firmly established itself as a global market leader in genomics-based research from India and a strong investment for our portfolio." "The convergence of sequencing technologies, computational power and algorithms, and other genomics advancements brings personalized medicine closer than ever to a cost-effective reality and along with it the promise of enormous improvements in drug discovery, diagnostics, and treatment of patients. By tapping the genetic power of India, we are able to further advance these critical patients' needs and, in doing so, significantly improve the health of global populations," said Mr Sam Santhosh, founder and CEO, MedGenome. MedGenome's Series A funding round was led by Emerge Ventures in June 2014. With the conclusion of Series B funding, Abhay Pandey of Sequoia Capital will join the MedGenome board of directors, which already includes Mr Sam Santhosh, Mr Mahesh Pratapneni of Emerge Ventures and Mr Dhiraj Rajaram of Mu Sigma.   ]]> https://biospectrumindia.com/news/97/6957/ge-healthcare-receives-accolades-from-frost-sullivan.html https://biospectrumindia.com/news/97/6957/ge-healthcare-receives-accolades-from-frost-sullivan.html Fri, 24 Jul 2015 12:27:43 +0530 Frost & Sullivan recently conducted an analysis of the cardiovascular image and information management systems (CIIMS) market, and recognizes GE Healthcare with the 2015 North American Frost & Sullivan Market Leadership Award in Cardiology Informatics. As part of this market research effort, the group gathered input from 120 clinical, IT and enterprise-level decision-makers in cardiology informatics. In addition to sharing their perspectives on the future of cardiology informatics, the health organizations evaluated vendors based on its product quality, product differentiation, brand perception and growth strategy. Demonstrating excellence at capturing the highest share in the North American cardiology informatics market, GE Healthcare ascended to the top of the leaderboard with the highest gains in installed base market share, particularly among the mid-to-large hospitals and integrated delivery networks. Frost & Sullivan found that 36 percent of hospitals and integrated delivery networks chose GE Healthcare as their primary vendor of cardiology image management solutions, well ahead of other competitors. "Frost & Sullivan's competitive benchmarking indicates that GE Healthcare has the highest vendor ratings among suppliers of CIIMS solutions," said Frost & Sullivan's principal analyst Mr Nadim Daher. He added, "Of the 77 percent who expressed strong customer satisfaction with GE Healthcare, 33 percent of users rated it 'excellent', and an additional 44 percent rated it 'very good'." Among the imaging modalities used in cardiovascular care, diagnostic and interventional catheterization (Cath) and echocardiography (Echo) were ranked the most popular. According to Frost & Sullivan's research, GE Healthcare is the vendor that is most likely to be considered by customers for both the Cath and Echo components of the CIIMS solution. This top ranking for the two anchor modalities of the cardiovascular service line contributes to GE Healthcare's strong position as a vendor of choice for the entire cardiology enterprise.       ]]> https://biospectrumindia.com/news/97/6696/confidence-building-measures-must-for-clinical-trials-in-india-experts.html https://biospectrumindia.com/news/97/6696/confidence-building-measures-must-for-clinical-trials-in-india-experts.html Fri, 24 Jul 2015 11:39:00 +0530 The Indian Society for Clinical Research (ISCR) has stated that in the recent times, several steps have been taken by the Indian regulators to bring clinical research in India back on track. The robust and streamlined guidelines as well as systems are now in place in the country for conducting clinical research.  However, it is being felt that there is also now need to restore confidence among all stakeholders. Given that India has the highest disease burden in the world, it seems only logical that the country should have a clinical research agenda of her own. On the contrary, despite being home to 17 percent of the population of the world and having a fifth of the world's disease burden, the Indian contribution to global drug trials is less than 1.5 percent. As per the statement of ISCR, there are thousands of patients, desperately waiting for new therapies and drugs to enter the market. In a media roundtable organized at All India Institute of Medical Sciences (AIIMS), the experts deliberated on the latest scenario. They maintained that the clinical research fraternity is not against regulation but there is a need to ensure that there is a strong regulatory framework rooted in the principles of science and research with quality, ethics, patient safety and confidentiality as its guiding principles. "Clinical research has not got the right perspective in the Indian context which has actually deprived our country from some very imperative and relevant research being ignored," said Samir Sethi, President, Indian Rett Syndrome Foundation and parent of a daughter diagnosed with Rett Syndrome. "While we have the requisite expertise, infrastructure and need in the country, however, certain factors have not permitted clinical research to grow as it should have. We hope that as the regulatory environment improves, a new dimension would unfold between the regulators and the patients, pushing clinical research not only by researchers and scientists in the country, but also as a preferred destination from overseas sponsors. Our children have a right to live with dignity and in an environment where there are investments being made in clinical research that could help them lead a better quality of life. We seek the support of the media in highlighting the cause of rare diseases in India and the challenges of patients living with illnesses for which there is no known cure." Prof Y K Gupta, Professor and Head, Department of Pharmacology, AIIMS, & Executive Council Member, ISCR said, "Clinical research is essential not only for developing medicines for emerging health concerns (such as XDR TB, antibiotic resistant pathogens, H1N1, Ebola virus, etc.) but also for finding safer and better medicines for entrenched diseases such as HIV, malaria, diabetes, hypertension etc. India, with its large patient population, unmet health needs, and limited resources, needs to make newer and better treatment options available to its population in a quick, economical and dependable manner. For this, India must take a proactive part in clinical research and assume leadership role globally. We must ensure that clinical research in our country is carried out as per global scientific standards, is moored in sound ethical foundations befitting a liberal democracy but is optimally oriented towards addressing national medical and health needs." "Events of the past have eroded the confidence of various stakeholders in conducting clinical research in India. The science of clinical research will be negatively impacted if we do not stabilize the environment for clinical research in the country soon enough. We have an obligation to ensure that patients have access to the best and most advanced treatment, made possible through clinical research, to alleviate their suffering," said Dr Shamsher Dwivedee, Head and Director, Department of Neurology, Fortis Memorial Research Institute, Gurgaon. "For many patients, time is of essence. I have personally experienced challenges in trying to access a clinical trial for my wife which was the only treatment option available for her," said Vivek Tomar, husband of a patient suffering from lung cancer. "For many patients, participation in a clinical trial can make a difference between life and death. Patients cannot wait and it is important for us to remember this. We need an environment that encourages and fosters clinical research so that patients like my wife can benefit." "There is a need to acknowledge the role of clinical trial patients who are unsung heroes and highlight their experiences and struggles, particularly those suffering from unmet medical needs. We need to build an environment that fosters clinical research, drug discovery and innovation through public education and awareness," said Suneela Thatte, president, ISCR. ]]> https://biospectrumindia.com/news/97/7416/indian-patients-being-denied-right-to-have-newer-medicines-iscr-president.html https://biospectrumindia.com/news/97/7416/indian-patients-being-denied-right-to-have-newer-medicines-iscr-president.html Fri, 24 Jul 2015 11:37:00 +0530 "There are many patients in India who are being denied the right to fair and equitable treatment to clinical trials and newer and more effective medicines that clinical research makes possible," remarked Ms Suneela Thatte, president, ISCR during an interaction with media on July 23, 2015 at All India Institute of Medical Sciences (AIIMS).  "It is ironical that while on one side we have success stories such as an indigenously developed and tested rotavirus vaccine which is now part of the national immunization schedule, on the other hand we have lost innovation opportunities due to the challenges we have had in the recent past. This is a compelling enough reason for us to ensure that over and beyond the regulatory developments, all of us work collectively towards rebuilding confidence and trust in doing clinical research in India so that our patients have access to news and better treatment," she added further.  To create an enabling environment for clinical research by raising awareness about its role and relevance, ISCR has launched a nationwide advocacy programme called NavChetana which operates through three tracks: Education Track which collaboration with educational institutions to sensitise students on clinical research; Professional Alliance Track which involves outreach with professional bodies, associations, NGOs, etc and Media Track which aims to generate mass awareness about clinical research. ]]> https://biospectrumindia.com/news/97/7165/toshiba-names-mr-satrajit-misra-vp-marketing-.html https://biospectrumindia.com/news/97/7165/toshiba-names-mr-satrajit-misra-vp-marketing-.html Thu, 23 Jul 2015 13:00:00 +0530 Toshiba America Medical Systems has announced that Mr Satrajit Misra has been named vice-president, Marketing. Mr Misra will be responsible for overseeing all business units, Corporate and Strategic Communications, Clinical Collaborations and Healthcare Economics with the goals of continuing Toshiba's growth and maintaining its commitment to putting customers first. "Mr Satrajit Misra has consistently demonstrated his leadership skills by driving year-over-year growth for our CT business," said Mr Shuzo Yamamoto, president and CEO, Toshiba America Medical Systems. He added, "He brings to Toshiba expertise in several different modalities as well as successful experience in marketing, sales and system development. Mr Misra has also developed synergetic relationships with colleagues around the world and we are looking forward to his application of this robust skill set to his new role." Mr Misra was most recently the senior director, CT Business Unit at Toshiba, increasing sales and launching new products, like the award-winning Aquilion ONE ViSION.   ]]> https://biospectrumindia.com/news/97/6638/ika-receives-top-100-innovator-award-.html https://biospectrumindia.com/news/97/6638/ika-receives-top-100-innovator-award-.html Wed, 22 Jul 2015 16:00:27 +0530 At the German SME Summit in Essen, IKA-Werke GmbH & Co. KG has been presented with an award recognizing the company as one of the most innovative medium-sized businesses in Germany. "Top 100" mentor Mr Ranga Yogeshwar honored the company with the seal of approval, IKA-Werke is "Top 100 Innovator" for the third time in a row and in 2015, reached second place in the category for companies with over 250 employees. "Good ideas and their rapid implementation are a key competitive factor for us," said Mr René Stiegelmann, president and owner,IKA-Werke. He added, "This is why we invest a great deal of time and money in our innovation management processes. As part of this, we rely on the wealth of ideas that come from all of our employees. I would like to thank them all for helping us achieve the 'Top 100 Innovator' award." The "Top 100" seal of approval is awarded after a two-stage review process developed by professor Dr Nikolaus Franke and his team from the Institute for Entrepreneurship and Innovation at the Vienna University of Economics and Business Administration. Analysts investigate the innovation management processes and their success using over 100 parameters across five categories. The decision on which medium-sized company is awarded the "Top 100" seal of approval is solely made by the analyst panel. The IKA Group is a global market leader for laboratory equipment, analytical and process technology.   ]]> https://biospectrumindia.com/news/97/3539/fda-approves-abbotts-idesign-advanced-wavescan-studio-system-.html https://biospectrumindia.com/news/97/3539/fda-approves-abbotts-idesign-advanced-wavescan-studio-system-.html Wed, 22 Jul 2015 12:01:18 +0530 Abbott has announced the US Food and Drug Administration (US FDA) approval and launch of the iDesign Advanced WaveScan Studio System. The system acts as the "brain" of the LASIK procedure, generating a high-definition scan that measures and maps irregularities of the eye that may impact vision. From these measurements, the iDesign System creates an accurate and personalized LASIK treatment plan based on the unique "blueprint" of each person's eyes. The iDesign System captures more than 1,200 micro readings of the eye, as well as identifying the shape of the cornea, its curvature, how light passes through the eye and pupil diameter under different lighting conditions, all in one, three-second scan that can be used to precisely correct vision. "The iDesign System for LASIK is a leap forward for laser vision correction in the United States, enabling a highly personalized treatment unique to the vision needs of each person," said Mr Leonard Borrmann, head of research and development for Abbott's vision business. He added, "The same technology used to help build NASA's new James Webb Space Telescope, which will allow high-definition views of space, is allowing us to map the human eye with great precision." In a clinical study on 334 eyes treated with the iDesign System, 99 percent of patients experienced little or no difficulty with the clarity of their vision and 97 percent of patients had little or no difficulty with their daily activities after surgery. In addition, patients saw significant improvements in their vision while driving at night and a reduction in glare. The iDesign Advanced WaveScan Studio has been approved in several countries around the world since 2012, including China and the European Union.   ]]> https://biospectrumindia.com/news/97/6499/philips-join-hands-with-a-canadian-medtech-firm.html https://biospectrumindia.com/news/97/6499/philips-join-hands-with-a-canadian-medtech-firm.html Wed, 22 Jul 2015 11:40:20 +0530 Royal Philips and Profound Medical, a Toronto-based medical device company, has announced that they have signed a joint development agreement to support Profound Medical's proprietary TULSA (Transurethral Ultrasound Ablation) technology designed to treat patients with prostate cancer on Philips' Ingenia and Achieva 3T MRI systems. Profound's TULSA technology is emerging as a new minimally invasive, whole gland ablation of the prostate. This single session procedure has the potential for outcomes comparable to the best of current treatment options, but with lower rates of side effects and higher quality of life for patients. "Philips has stepped forward and enthusiastically shares our vision for the technology. With their support, TULSA-PRO will soon be available to clinicians and patients for primary treatment of localized prostate cancer. This new relationship will provide us with access to a large installed base of MRI systems and customers and we look forward to developing this mutually rewarding relationship further," said Mr Steve Plymale, CEO, Profound Medical. As a leader in image-guided therapies Philips is expanding its efforts in the fast growing interventional oncology domain. MRI is emerging in oncology applications, because of its excellent real-time 3D visualization of soft tissue and Philips has a suite of industry-leading solutions for MRI guided procedures. Philips has deep expertise and experience in providing clinical solutions for prostate MR imaging. "With 3T MRI emerging as a technology standard for multi-parametric MRI diagnostic imaging of the prostate, our collaboration with Profound Medical will enable us to offer our customers access to a novel MR guided ultrasound ablation therapy that's critical to prostate care research," said Mr Christopher Busch, general manager MR Therapy, Philips Medical Systems. He added, "We look forward to teaming with Profound Medical to refine the integration of our technologies and drive clinical research and reimbursement efforts with the ultimate objective to improve clinical performance and enhance the patient experience."   Profound Medical will soon release 12 month data from its 30 patient safety and feasibility study with the goal of obtaining a CE mark and commercialization of TULSA-PRO in Europe and Canada in 2016.   ]]> https://biospectrumindia.com/news/97/6518/canon-presents-its-digital-radiography-solutions.html https://biospectrumindia.com/news/97/6518/canon-presents-its-digital-radiography-solutions.html Tue, 21 Jul 2015 12:43:33 +0530 Canon USA and Virtual Imaging has announced that they will showcase their lineup of digital radiography (DR) solutions, including the RadPRO2 radiology solutions at the 2015 American Healthcare Radiology Administrators Exposition (AHRA) at the Sands Expo Convention Center in Las Vegas (Booth # 619), July 20 - 22, 2015. Canon and Virtual Imaging present a variety of digital radiography solutions designed to provide healthcare professionals cost-effective, productivity-enhancing solutions. In addition to exhibiting the newest RadPRO radiology solutions, Canon USA will acknowledge another major milestone, as its parent company, Canon Inc., has reached 30,000 global sales of digital radiology (DR) detectors. "Canon and Virtual Imaging are focused on providing innovative solutions that meet the individual needs of our customers and can help accelerate exams. We look forward to demonstrating at this year's AHRA how our high-quality imaging solutions are cost-effective and can be used to help maintain effective workflows," said Mr Tsuneo Imai, vice-president and general manager, Healthcare Solutions Division, Business Imaging Solutions Group, Canon and president, Virtual Imaging. Attendees will learn how Canon DR capabilities can be shared among rooms with the RadPRO DELINIA 200 Digital X-ray Acquisition Cart, which transports the Canon detectors featuring auto-detection mode. The detectors work with existing installed X-ray generators or mobile system generators. The DELINIA cart, which was designed to help increase productivity, comes equipped with a choice of Canon CXDI-701C/801C/401C Wireless Detectors designed to deliver high-resolution imaging with a low X-ray dose.   In addition, the Company will be displaying RadPRO DR overhead radiology room and mobile solutions. The RadPRO OMNERA 400T Digital Radiographic System incorporates a lightweight, rugged construction with tube-mounted 10-inch touch screen and tight integration with certain Canon CXDI digital detectors, which are sold separately. This manual positioning system provides servo tracking to both the wall stand and table to provide precision positioning quickly and easily. Designed to help healthcare professionals meet the challenges of demanding imaging departments and help create an efficient workflow to increase patient throughput, the RadPRO OMNERA 400T System can be a "workhorse" for hospitals, imaging centers and clinics. Healthcare providers can maximize resources and simplify workflows through the use of a comprehensive RadPRO mobile and portable radiology solution. With its compact and easy-to-maneuver design, the RadPRO 40kW Digital Mobile X-ray System provides the flexibility to bring the radiography room to the patient and allow administrators to maximize office space by reducing the need to have dedicated rooms for specific procedures. The Enhanced Workflow Package helps technologists complete routine tasks from the patient's bedside without having to access a HIS/RIS from a dedicated workstation.     ]]> https://biospectrumindia.com/features/97/4879/no-plans-to-expand-in-other-indian-cities-us-pharmacopeia-.html https://biospectrumindia.com/features/97/4879/no-plans-to-expand-in-other-indian-cities-us-pharmacopeia-.html Tue, 21 Jul 2015 12:42:00 +0530 A part of this investment will be made in India. It aims to execute multiple activities in the country including medical monograph modernization, increasing resources, building manpower, and expanding technology-related activities. In 2005, USP opened its first office and collaborative testing laboratory facility outside of the United States, near Hyderabad. "Since USP India's opening, India's pharmaceutical industry has continued to grow rapidly, resulting in an increased demand for USP standards and services," said Dr K V Surendranath, SVP, International Site Operations, USP-India. The USP India facility works to create standards for medicines ensuring full safety and quality of medicines, and brining international standards in drug manufacturing to India. The not-for-profit organization develops reference standards to ensure the quality of Active Pharmaceutical Ingredients (APIs) and supports government's initiatives to strengthen domestic manufacture of intermediaries and APIs.   $20 mn in 4 years In 2011, USP expanded from 14,000 square feet to more than 100,000 square feet in a new facility. It has spent over US $20 million over the past 4 years to improve its infrastructure and capacities. This allowed the organization to increase its capacity for analytical chemistry and microbiological testing, and as well as to explore new initiatives in bioanalytical chemistry and testing, and synthetic chemistry. Added Dr Surendranath, "The expansion has been integral to the collaborative testing needed to develop reference materials for the United States Pharmacopeia and the National Formulary (USP-NF)." $200 mn investment Currently USP Hyderabad has a head count of 150 employees, and it plans to expand its capacity, and grow its activities based on local requirements and demands from the industry. ".... As the industry grows and drug testing activities increase, we will continue to increase our capacity and facilities accordingly," pointed Mr Surendranath. Furthermore, in the next 5 years, it plans to spend US $200 million to notch-up its operations across the globe. "This investment will be used to revise at least half of USP's drug testing monographs using the latest technology and drug testing procedures," voiced Dr Surendranath. Working with USFDA Manufacturers that market drug products and their ingredients (active and inactive) in the US are expected to comply with USP's quality standards, and the standards are enforced by the US Food and Drug Administration (USFDA). USP's process for developing and updating standards include incorporating inputs from experts in the industry, academia, and the government, and the USFDA. "In addition, scientific experts from USFDA regularly participate in USP's workshops, forums and related meetings," revealed Dr Surendranath. India site's uniqueness According to USP India, the Hyderabad site is largely involved in activities similar to those at USP's US and other sites, such as collaborative studies for development of reference standard, education, and training programs. Some of the activities which are unique to the India site are the synthetic laboratory, industry support programs, and the site serving as a global hub for tests conducted for USP's verification programs. As of now, the organization does not have any plans in expanding further to other Indian cities. USP and its stakeholders  USP works with USP India to improve quality and reference standards for pharmaceutical ingredients It also works with Indian manufacturers on collaborative testing, verification testing, pharmacopeial education, customer support, and sourcing of written and physical standards for drugs The organization educates local companies on reference standards besides supporting existing customers  The Hyderabad facility has been working in collaboration with various labs for developing reference standards in India ]]> https://biospectrumindia.com/news/97/6451/ppd-achieves-ceo-cancer-gold-standard-reaccreditation.html https://biospectrumindia.com/news/97/6451/ppd-achieves-ceo-cancer-gold-standard-reaccreditation.html Tue, 21 Jul 2015 12:05:39 +0530 Pharmaceutical Product Development (PPD) has announced that it has achieved the CEO Cancer Gold Standard reaccreditation from the non-profit CEO Roundtable on Cancer for maintaining a strong commitment to the health of the company employees. The company said it encourages employee participation in health and wellness programs, including cancer prevention and screening, nutrition coaching and fitness classes, to promote healthy lifestyles and empower employees to take an active role in managing their health. "PPD is committed to the fight against cancer," said Mr David Simmons, chairman and chief executive officer of PPD. He added, "As a global contract research organization with deep expertise in oncology, we are dedicated to helping biopharmaceutical clients deliver safe treatments to patients more quickly, cost-effectively and with the highest possible quality. We are pleased the CEO Roundtable on Cancer has recognized our efforts in employee health and wellness, and we applaud their worthy mission." PPD has conducted in excess of 420 hematology and oncology studies in the past five years at more than 23,000 research sites involving greater than 100,000 patients. the company has a global network of more than 8,000 hematology and oncology investigators. The CEO Roundtable on Cancer developed the Gold Standard as an employee wellness framework based on concrete actions for companies to take in five key areas, establishing policies and programs to reduce cancer risk by prohibiting tobacco use and supporting tobacco cessation efforts; promoting physical activity, healthy nutrition and weight management; providing health insurance options that include detecting cancer at its earliest stages, access to quality care and participation in clinical trials; promoting employee awareness of these initiatives; and supporting the needs of cancer survivors in the workplace.   ]]> https://biospectrumindia.com/news/97/6370/transasia-introduces-new-product-.html https://biospectrumindia.com/news/97/6370/transasia-introduces-new-product-.html Mon, 20 Jul 2015 12:29:24 +0530 Transasia Bio-Medicals, an in-vitro diagnostic company has announced the launch of its latest semi-automated coagulation analyzers, the ERBA ECL 105 and ECL 412, equipped to perform the D-dimer assay. The ERBA D-dimer reagents are available in a small pack size of 50 tests only, with no reagent reconstitution. It is ready to use with a stability of four weeks. The affordability and easy availability of the D-dimer assay, ensures that every laboratory can perform this test, on the ECL 105 or ECL 412 semi-automated, coagulation platform.   ]]> https://biospectrumindia.com/views/97/7772/india-lacks-innovation-culture-collaboration-is-the-way-forward-industry.html https://biospectrumindia.com/views/97/7772/india-lacks-innovation-culture-collaboration-is-the-way-forward-industry.html Sun, 19 Jul 2015 09:14:00 +0530 The forum brought India's leading Life Sciences personalities and game changing masterminds to discuss and contemplate the future of Indian Life Sciences industry by the year 2020. The star-studded panel discussion was garnered by eminent faces including Dr K K Narayanan, MD, Metahelix Life Sciences; Dr Rashmi Barbhaiya, CEO & MD, Advinus Therapeutics; Ms Bindhya Cariappa, COO & EVP Emerging Markets, ClinTec International; Dr Goutam Das, COO, Association of Biotechnology Led Enterprises (ABLE); Ms Rooma Bussi, Country Head - India, SDI; and Dr Sharon McKendry, Life Sciences & Chemical Sciences International Sector Head, SDI. The panel discussion was moderated by N Suresh, group editor of BioSpectrum publication. Dr Rashmi began the panel discussion by speaking about the significance of innovation and collaboration in the pharma industry. "Having spent 30 years in the US, I came back for one reason -- the young Indian talents, since there is no past legacy for them. The manner in which young people go about finding innovation is amazing. Many companies from Europe, US and Japan have been in India for a long time. The cost of innovation in their respective countries is high and hence, they lookout for cheaper labor to solve issues," he opined.   The event witnessed 40+ attendance ranging from start-up CEOs to industry veterans, from deans of prestige institutes to research scientists and media fellows. "The biggest challenge the industry is facing now is affordability and accessibility of medicines. The pharma innovation has no choice but to be a global network for innovation. Pharma companies need to look for places where innovations can be done best, faster and cheaper. No one company or country can do it all. To bring affordable and innovative medicines, we have to work together," Dr Rashmi emphasized. Dr Binay Panda, Chief Officer & Head, Ganit Labs, said that innovation does not happen in large companies. "Young people need to know how researchers and scientists in labs do innovation, and then take it to the real world. Innovation starts from the labs. We need more innovation success stories," he pointed. Another panel member, Ms Bindhya Cariappa, expressed that India has great potential to perform well in clinical trials. "We are living in challenging times. We have taken a lot of time to get where we are. They key is what difference are we going to make in people's lives and reach out to those who are involved in the healthcare delivery. When we started clinical trials, it was very new. Trials are the only opportunity for treatment and access of diseases. Regulatory reforms takes time. Today there is change in the technology and we need to push certain things. We have the potential to do extremely well in clinical trials. India promises efficiency through leveraging technology which ensures affordability and quality healthcare," she explained. Dr Ajith Kamath, Head, External R&D Innovation, Pfizer India, pointed the significance of collaborations in a globalized world. "Today, two-thirds of the world are touched by vaccines from India. When we look at the big picture, most of the molecules are made in India. Today, about 60-70% of the molecules in the pipeline are coming out of collaborations and not just from one particular company. Collaboration is the way forward. There are many opportunities to collaborate with Indian companies," he held. Dr Raviraja Seetharam, Deputy Director, Business Development, Stempeutics Research stated, "Globally the biopharma industry recorded revenues of US $180 billion, out of which US $5 billion is from India. There is a lack of talent pool. We need to come together, collaborate and globalize products." Dr Sharon shared insights on collaborative innovation and Scotland's offer to companies who want to set up their bases there. "Currently I'm seeing a lot of entrepreneurship and customer focus in companies, as a lot of new technologies are coming up. In Scotland, we have more than 170 core medical devices companies, 140 pharma service organizations, and top 10 global CRO firms. Scotland is the land of innovation, all the way dating back from discovering penicillin to the cloning of the first animal, Dolly," she highlighted. By 2020, the global population will reach 8 to 9 billion. This implies there is going to be increased demand for food, and the demands are going to stem from the developing world. "We are a country of 1.3 billion people, and will touch 1.4 billion plus by 2025. It is estimated that India may need 450 million tons of food grains. Today, we produce about 250 million tons. By 2020, Bangalore, by population, will be twice the size of Scotland. India is second only to US in terms of arable land. 50% of the landmass in India is ploughed allowing no scope for further expansion. As we move forward, the land is going to diminish further. We have to increase the productivity and technology is going to be the key," stressed Dr K K Narayanan. He believes that Indian agriculture is a prisoner of old and outdated technologies. "We are doing well in terms of opportunities. But we are lagging behind in productivity. This is where the opportunity lies. Today we have a burden and a need. There are skills available to do the adaptive. Things can be tested, and yes, we do have challenges of regulatory and activism, but they can be overcome. In our country, I believe, you can only delay things but can't deny, because farmers in the country ultimately get it one way or the other," he voiced. Dr Goutam emphasized how ABLE is involved with the government and other stakeholders to encourage more start-ups. "The challenge is, we definitely want to encourage smaller start-ups in getting funding rather than depending solely on DBT or BIRAC grants. Private equities always look for quicker profits, maturity and exits. In drug discovery this is not the case. ABLE is talking to SEBI and the government to get into these areas where they can support smaller biotech start-ups by replicating the US model, where they can float shares and get into investments. The number of start-ups have definitely increased. Since 2009, we have launched more than 10 to 12 start-ups in different areas," held Dr Goutam. Speaking about the Biodiversity Bill, he revealed, "One of the other issue is that the government should know how to go about biologics, biosimilars and biobetters. We are pushing the government to streamline the process and make things faster by 180 days. We are also trying to address the Biodiversity Bill. We are working with different government forces to find out what the government's position is with the Bill. The Bill is making it impossible to bring things in or to take them out of the country." Dr Rashmi also mentioned the approval pain that companies go through in the drug discovery process. "When we discover a new molecule, we have to make enough quantity of it to obtain approval, which takes months from the Drug Controller General of India (DCGI), to conduct clinical tests in animals and proceed with clinical trials. Every molecule is under patent, and the stakes are high while developing a molecule when we wait for the approval, which can go up to 18 months, when it takes less than a month in other countries," Dr Rashmi said. Dr Sharon ended by speaking about various funding mechanisms available in Scotland. "In Scotland, there are huge expert communities dealing with funding options. There are seed funding, co-investment funding and suitable funding partners. For companies, who want to come into Scotland, we have mechanisms to support them with grants and help them with their expenditure costs and setting up. There is a whole range of funding mechanisms available." Dr Rashmi feels that India is lagging behind in innovation culture. "It (India) is more of generics oriented. It hasn't introduced many innovative medicines, and hence there are revenue discrepancies in the pharma industry. Due to the success of generics, established companies are averse to investing towards long-time innovation. The pharma innovation has about 10 to 15 years of waiting period," he remarked. ]]> https://biospectrumindia.com/news/97/7126/trivitron-healthcare-launches-two-new-tests-.html https://biospectrumindia.com/news/97/7126/trivitron-healthcare-launches-two-new-tests-.html Fri, 17 Jul 2015 13:06:45 +0530 Trivitron healthcare has added two new products in the Newborn Screening kit. With this launch, they aim to create better future for newborn babies in the country by providing corrective diagnosis at birth. The two new tests are Neonatal IRT and Neonatal Toxoplasma gondii IgM that detect disorders which may harm the newborn in later stages of life. The company already offers Newborn screening assays through the Labsystems diagnostics brand, like TSH, PKU, 17OHP, G6PD, Galactose and Toxoplasmi gondii. Together with its fully automated NS2400 platform, Trivitron has launched two new products to complement its newborn screening panel. Neonatal IRT can detect disorders affecting the lungs, pancreas, intestine and liver. Whereas, Neonatal Toxoplasma gondii IgM can detect neurological and visual disabilities. Dr GSK Velu, founder and MD of Trivitron Group of companies said, "Trivitron Healthcare is taking strong steps towards women and child healthcare diagnosis. The thought behind adding two critical tests to the kit is to eradicate detected problems in the newborn at early stages for better lifestyle and to live a carefree life. Trivitron is known for its innovation in medical technology sector and making it available and affordable to larger section of the population across the globe."     ]]> https://biospectrumindia.com/news/97/4464/medtronic-to-acquire-rf-surgical-systems.html https://biospectrumindia.com/news/97/4464/medtronic-to-acquire-rf-surgical-systems.html Thu, 16 Jul 2015 10:48:32 +0530 Medtronic has announced that it has signed a definitive agreement to acquire RF Surgical Systems Inc, focused on the detection and prevention of retained surgical items (sponge, gauze or towel) for approximately $235 million. Additional terms of the acquisition were not disclosed. The RF Surgical system is designed to be used as an adjunct to manual counting methods to help prevent such surgical sponge-related never events, which are serious, largely preventable, and harmful clinical events. The proprietary detection system uses a low radio frequency (RF) signal to track and detect surgical gauze, sponges and towels (embedded with a RF tag) through blood, dense tissue and bone. The technology aims to reduce patient complications due to surgery, lessen unnecessary procedures, and increase efficiencies within the operating room. "Patients are our priority. Improving patient safety and outcomes is our daily focus, which directly aligns with the RF Surgical technology, a simple and cost-effective solution to avoidable complications in surgical procedures," said Mr Chris Barry, senior vice-president and president of the Surgical Innovations business, Minimally Invasive Therapies Group at Medtronic. "We are pleased to be joining the Medtronic team as their long-standing commitment to patient safety closely aligns with RF Surgical" said Mr John T Buhler, CEO of RF Surgical. He added,  "As we strive to make the RF Surgical technology the global standard of care, we look forward to the innovation opportunity afforded by our combined capabilities." Medtronic will report the RF Surgical business as part of its Surgical Solutions division within the Minimally Invasive Technologies Group. The transaction is expected to meet its long-term financial metrics for acquisitions, and the annualized earnings impact of this acquisition is not expected to be material. The deal is expected to close in August 2015, pending regulatory approvals.   ]]> https://biospectrumindia.com/news/97/5948/astrazeneca-vida-health-team-up-to-develop-new-app.html https://biospectrumindia.com/news/97/5948/astrazeneca-vida-health-team-up-to-develop-new-app.html Wed, 15 Jul 2015 14:00:00 +0530 AstraZeneca has teamed up with Vida health to launch a new app- 'Day-By-Day' for speedy recovery of heart attack patients, to cope up with the stress and trauma associated with such life-threatening experiences. The app is an extension of Vida Health's current cloud-based smartphone app, and is launced through a trial program at Duke University. The app is a HIPAA-compliant smartphone application that will walk patients step-by-step through the recovery process using live digital coaches and educational materials, like videos, articles, and food journals, to help patients implement lifestyle changes and adhere to their new drug regimen. Every year millions of people duffer from heart diseases and the app is expected to offer patients hands-on rehabilitation can by helping patients understand what medications to take when, how to change their eating habits or quit smoking, and how to slowly develop an exercise routine. The app will also help AstraZeneca interact with patients "beyond the pill." Mr John McCarthy, vice president of global commercial excellence at AstraZeneca, added, "The science is the core of our business, but patients today are expecting more. We see that taking advantage of technology alongside the power of science is the best thing for patients. It's about extending the customer experience." ]]> https://biospectrumindia.com/news/97/4644/cole-parmer-holds-industry-connect-event-at-ncr-.html https://biospectrumindia.com/news/97/4644/cole-parmer-holds-industry-connect-event-at-ncr-.html Wed, 15 Jul 2015 10:24:34 +0530 Held on July 03, 2015, the Cole-Parmer seminar titled, 'Solutions from Research to Process' offered an exclusive forum for interaction with key customers in Gurgaon and around from leading pharma companies, testing laboratories and research institutes. The experts and senior leaders from the company had a free discussion with lot many representatives from reputed brands such as Baxter, Bureau Veritas, Daiichi, FRAC, Fresenius, Honeywell, Intertek, Jubilant, Pancea, Sunpharma, Lanco, IPFT, and ISRL attended the event. The company also launched its newly introduced India Catalog 2015-16, during the event that was attended by over 120 persons. While the clients expressed their happiness on being invited for such an interaction, Cole-Parmer management too was appreciative of receiving the positive feedback. There was enthusiastic response to the various technical sessions where experts provided insights into each of the product categories. The highly informative presentations were followed by the question and answer sessions as well. The attendees were also asked to rate the services and their requirements through digital response system. This helped the company in getting the first hand direct information from the clients. The company also had put their key products and hot sellers on the display for the participants to have a look and feel of it. While addressing the clients, Mr Rakesh Aggarwal, managing director-Asia Pacific, Cole-Parmer said, "After we started independent operations in India, we've been rigorously concentrating on setting up of renewed operations to improve customer experience. We're confident that our customers will be benefited in the coming days." Few of the clients who spoke to BioSpectrum were satisfied with the overall services of Cole-Parmer. They, in particular, talked about high end technology, fast response, customized service for various products. "The company which is known for unique innovative technologies, offers us quick services whenever required," said a customer who has been using the products of Cole-Parmer over a decade now. Another client who belonged to top management of a renowned pharma firm in Gurgaon, mentioned, Cole-Parmer offers excellent application expertise and technical support. The quality is unmatchable and we have been hooked to their products since long." Founded in 1955, Cole-Parmer offers a portfolio of industry-leading brands and private-label products in niche applications to fulfill important needs in the research and process areas. The business has deep technical expertise across a range of specialty products in the field of fluid handling, test and measurement, electrochemistry and other laboratory products. As per its top management, the latest event by Cole-Parmer is one of the series of events planned across India. ]]> https://biospectrumindia.com/news/97/4641/biosuppliers-want-govts-attention-to-pending-issues.html https://biospectrumindia.com/news/97/4641/biosuppliers-want-govts-attention-to-pending-issues.html Mon, 13 Jul 2015 10:38:00 +0530 The biosuppliers were eagerly looking at some announcement for hassle free business and rebates over import taxes of research products. Besides that, the funding allocations to research institutes were also expected to go up. But there has been no progress so far on these. Echoing the common view, Dr Vishal G Warke, director R&D, Cell Culture and Immunology, Himedia Laboratories mentioned, "We are still waiting for the Modi government to release the funds for most of the research institutions in India, as the lack of funds and grants from the central government has adversely impacted our sector. Scientists are unable to buy a lot of reagents and products as they are still waiting for the funds to be disbursed." However Dr Warke, like his other counterparts in the industry, hasn't lost hope yet. He optimistically adds further, "On the whole however, the mood is very encouraging and positive with the Modi government and we feel that things should improve dramatically in the next year, in the biotech sector." As per Mr Praveen Gupta, founder and executive director, Premas Life Sciences, "Our crystal ball gazing and interviews with soothsayers in the field predicts a promising next year with respect to growth in the applied markets and service providers business where as academic funding might still remain a challenge." The focus on non-adversarial, corruption-free and predictable policy regime is the core strength of the present government. As per critics, the first year's rule can be given full marks only in foreign policy and economics but a lot remains to be done for health, agriculture, education and science. While the Swach Bharat Abhiyan and Make in India surely are being appreciated as unique programmes but it will take a longtime to witness a visible change on ground. "India's biotechnology industry is on the cusp of entering a new era as the government focuses its efforts in building a research ecosystem that would spur medical innovation. It will take some time and too early to speculate, remarked an expert. This sums up the overall mood. Despite unmet expectations, industry seems to be hopeful of increased momentum over resolving specific issues of more regulatory clarity, business friendly environment and taxes. While the beginning has been good, this government surely has a lot to do and achieve. Perhaps industry will have to hold their horses for some more time. ]]> https://biospectrumindia.com/news/97/8443/bioclusters-an-imported-american-concept.html https://biospectrumindia.com/news/97/8443/bioclusters-an-imported-american-concept.html Fri, 10 Jul 2015 17:09:00 +0530 KBITS (Karnataka Biotechnology and Information Technology Services) organized a workshop titled 'Creation of Mega Biocluster in Karnataka' on July 8, 2014, at the soon-to-be opened Bangalore Bioinnovation Center (BBC) in Bangalore. The workshop brought forward issues dealing with the creation of bioclusters in India, and it also sought to hear and address the plethora of bottlenecks faced by biotech start-ups in running their enterprises. "The key factors for innovation success are three major ingredients: infrastructure, human resources and networking. India is a land of challenges. For most of those challenges, the solution lies in life sciences and information technology. Challenges create opportunities for innovation," said Dr Jagadish Mittur in his speech, who is the Head of Biotechnology Facilitation Cell, KBITS, Department of IT BT and S&T, Government of Karnataka. Speaking about collaboration in Life Sciences, Dr Mittur pointed, "In India we seem to work in silos and compete, rather than collaborate. Networking and collaboration are the keys. There are complexities to solutions lying in life sciences. It is time we collaborate and setup facilities needed to collaborate. Necessity is the mother of all innovations. We need to identify rural and urban challenges, define objectives and check the market requirements and benefits for the society." Currently there are 5 Government of Karnataka (GoK)-enabled upcoming Bioinnovation clusters in the State:   1. Helix Biotech Park in Bangalore (KBITS/IBAB)2. Nutri/ Nutraceutical and Phyto-Pharmaceutical Park (N2P2) at Mysore (CFTRI)3. Agri Biotech Park at Dharwad (UAS-Dharwad)4. Marine Biotech Park at Mangalore (College of Fisheries - KVAFSU)5. Vivarium (Animal House) at Bidar (KVAFSU) It was also noted that international bioclusters are also being considered for possible collaborations and design. They include Chuncheon Bioindustry Foundation (CBF), South Korea and Biovillage, Maryland, USA. Another speaker, Prof H Sharat Chandra, Honorary Director, Centre for Human Genetics (CHG), offered further insights into collaboration. "It is not easy to create mega bioclusters. Biocluster is an American idea. The idea of bioclusters is to bring together people, technology and ideas and ultimately collaborate, where groups of individuals work together to achieve higher goals which neither of them will be able to do it on their own. In India, we need to overcome the cultural issue of not collaborating. People do not collaborate mainly because of IPR, patenting and competition. If we don't, countries elsewhere will collaborate, develop, evolve products, publish and patent," he opined. Before narrowing down the location to Electronic City, other locations including Hebbal, Whitefield and Manyata Tech Park (MTP) were considered for erecting the BBC.   However due to various land-related issues, the current Electronic city location was finalized. "Presence of high-tech equipments and highly qualified personnel will enable successful interaction and collaboration. Bangalore is the VC capital of India. VCs must take risks in encouraging innovation," Prof Chandra stressed. Prof N Yathindra, Director, Institute of Bioinformatics and Applied Biotechnology (IBAB) gave an overview of start-ups incubated at IBAB between 2002-15. Only one start-up was incubated in 2002, 2005 and 2008 respectively. However this number increased to 8 with two start-ups each year in 2006, 2009 2011 and 2013. In 2014-15, 5 start-ups were incubated each year, adding up to 10. The start-ups include:  BioCOS Life Sciences Cellworks Denovo Biolabs Genelife Biologics Geniron Good Herb Therapeutics Indoor Biotechnologies Ixora Biosciences Microtest Innovations MIR Life Sciences Novozymes R&D Omix R&D Lab Pentavalent Privils  Scintilla Bio-Marc  Shodhaka Life Sciences Simbiosys Biowares StringBio ]]> https://biospectrumindia.com/news/97/3861/interpretomics-to-raise-series-a-funding-in-sept.html https://biospectrumindia.com/news/97/3861/interpretomics-to-raise-series-a-funding-in-sept.html Thu, 09 Jul 2015 16:10:00 +0530 The lab measures 600 sq ft in area, and houses equipments manufactured by major suppliers including Agilent, Illumina, Thermo Fisher Scientific and Millipore. "This is a centre of excellence. We are focusing on research, development and delivery model (RDD). Our USP is in carrying out R&D along with the delivery. The centre will cater to research, clinics and as well as organizations in the pharmaceutical, biotech, and bioagri sectors," said Mr Prahalad Achutharao, co-founder & CEO, InterpretOmics. As of now, the company is awaiting approval certifications from DSIR (Department for Scientific & Industrial Research), and NABL (National Accreditation Board for Testing and Calibration Laboratories). The newly inaugurated centre will cater to its growing customer base in sequencing and analysis. The space also houses a bio-banking facility. Mr Achutharao explained that usually sequencing and analysis happens with two different parties, which brings certain conflicts if there were to be any discrepancies.   "We offer both sequencing and analysis and thus create comfort, convenience and credibility to our clientele," he stressed. The company caters to customers across the globe, but have had more of them outside India, from countries including Germany, the US, Middle-East and South-East Asia. "We are working through partners in majority of these countries," Mr Achutharao pointed. InterpretOmics in 2013 raised seed fund worth Rs 10 crore. Come September, it is geared up to raise Series A funding from institutions both in India and abroad. The company's dry-lab, measuring 7000 sq ft, was inaugurated in April 2015 in Bangalore, where all its major analytical products will be developed.     InterpretOmics now employees 35 professionals and looks to achieve a headcount of 40 by the end of July 2015. Its clientele includes 20 leading organizations and research institutes including, Illumina, National Centre for Biological Sciences (NCBS), Biocon, CSIR-Institute of Genomics & Integrative Biology (IGIB), Indian Institute of Chemical Biology (IICB), Tata Institute of Fundamental Research (TIFR), Justus Liebig University (Germany) and Istituto Europeo di Oncologia (Italy) among others. InterpretOmics was started with an initial investment of Rs 5 lakh in 2009. The company was also co-founded by Prof Asoke K Talukder, who is also the chief scientific officer (CSO) of InterpretOmics. ]]> https://biospectrumindia.com/news/97/7240/quest-life-sciences-receives-who-notice-reports.html https://biospectrumindia.com/news/97/7240/quest-life-sciences-receives-who-notice-reports.html Wed, 08 Jul 2015 13:04:28 +0530 According to reports, Quest Life Sciences has received a 'notice of concern', or NoC from the World Health Organisation (WHO) for 'critical' lapses and deviations from standards in its clinical trials of HIV drugs. The WHO's prequalification team had visited the Chennai-based Contract Research Organisation (CRO) Quest's facilities in October 2014 and inspected the clinical trial of Lamivudine, Zidovudine and Nevirapine, a combination of drugs for treating HIV patients. Reportedly, the team observed lack of data integrity in clinical trial records, failures in protection of subject safety, inadequate quality assurance. The team further said that  67 percent of the subject pre-study electrocardiograms (ECGs) were duplicates, with the details of the patients and dates having been changed to make the ECGs appear as if they were from different subjects who had participated in the study. "This means that ECGs may not have been performed or were unreliable and therefore ineligible/unfit subjects could have been used in the study and protocol requirements may not have been met," the WHO said in a statement. The company has said it will conduct the entire clinical study again at its own cost, to ensure the lifting of the NoC.   ]]> https://biospectrumindia.com/news/97/6154/toshiba-inks-pact-with-merge-healthcare-.html https://biospectrumindia.com/news/97/6154/toshiba-inks-pact-with-merge-healthcare-.html Wed, 08 Jul 2015 11:48:19 +0530 Merge Healthcare has announced that it has entered into a strategic partnership with Toshiba Medical Systems. Under this new agreement, Toshiba will be able to offer its customers a full turnkey solution, combining Merge's cardiology PACS and hemodynamic monitoring solutions with its vascular x-ray systems. "At Toshiba, we understand our customers' concerns when it comes to integrating IT solutions with imaging," said Mr Satrajit Misra, vice-president, marketing, Toshiba Medical Systems. He added, "Through this partnership, our customers will get a complete solution for accessing imaging information faster to improve the patient experience and our customers' overall business." Toshiba will leverage Merge's Best in KLAS Merge Hemo, Merge's real-time documentation tool for the cardiac cath lab that facilitates the integration of cath lab documentation into the patient's electronic health record, and Merge Cardio, the company's web-enabled enterprise-level image and information system that provides a single point of entry to the patient's complete cardio record spanning all cardiac modalities. "For more than 15 years, the Toshiba Corporation has been a great partner with Merge and we are pleased to expand our partnership with Toshiba America Medical Systems to support their enterprise imaging initiative for a unified, interoperable cardiology management system. Being an enterprise imaging preferred partner is an honor, and we look forward to helping them achieve their objectives," said Mr Justin Dearborn, chief executive officer at Merge Healthcare.   ]]> https://biospectrumindia.com/interviews/97/6472/how-iit-ms-bioincubator-is-changing-the-face-of-biotech-start-ups-era.html https://biospectrumindia.com/interviews/97/6472/how-iit-ms-bioincubator-is-changing-the-face-of-biotech-start-ups-era.html Wed, 08 Jul 2015 08:30:00 +0530 It is currently funded by Biotechnology Industry Research Assistance Council (BIRAC), and incubates start-ups in the area of biotechnology. In his special interview to BioSpectrum, Prof Guhan Jayaraman, department of biotechnology, Bhupat and Jyoti Mehta School of Biosciences, IIT-Madras, sheds light on how the government, industry and academia can collaborate together in revolutionizing the birth of biotech start-ups era.Q: What is the incubation model that you follow at the centre? Prof Guhan: Start-ups who are interested in being incubated have to apply through the website with a brief proposal. They will be called for a presentation before the Bioincubator Screening Committee consisting of academics, entrepreneurs, scientists from industry and medical institutions. The committee selects them based on five criteria: Technical merit of the proposal, business strategy for commercialization, team expertise, availability of seed-funding or venture capital and compatibility with the infrastructure and space available in the bioincubator. The selected companies are allowed to incubate for an initial period of 2 years which is extendable, depending on progress and financial sustainability of the incubated company and other assessment criteria.   The Bioincubator provides a comprehensive wet-lab facility consisting equipments for microbial or cell culture, bioprocess engineering, molecular biology and analytics. It also provides technical services and, through the IIT-M Incubation Cell, it provides the incubated companies with legal, accounting and other non-technical services. It also connects the incubated companies with a mentor network consisting of academics, biotech entrepreneurs, industry experts and venture capitalists. In addition, the Bioincubator also provides linkages with other institutions, and incubation centres for using specialized facilities which are not available at the IIT-M Bioincubator. Being incubated in an academically-linked ecosystem also provides the start-up companies with a rich resource of faculty mentors, and students are also hired for internships and employment. The IIT-M Bioincubator does not by itself provide seed funding. Q: How can this model be replicated to kick-start biotech start-ups boom in India? Prof Guhan: BIRAC has already identified and funded a dozen such bioincubators across the country, including three in IITs. However, it is not enough to provide funding to the bioincubators and expect immediate success stories. The Government (BIRAC), industry and academia need to be more holistically involved in this process to streamline the functioning of bioincubators, identify promising companies or technologies which require support and minimize chances of failure. There needs to be a thorough understanding of the bioincubation process and factors which will give better chances of commercial success. Finally, bioincubators need to be located in an ecosystem where there is a rich mix of industry-academia interaction and a diverse set of start-up companies. Q: What are the key investments needed to create, say, 2000 biotech start-ups by 2017? Prof Guhan: Long-term venture capital and availability of physical infrastructure are no doubt the key ingredients for biotech start-ups to test ideas and build technologies. However, even more critical is availability of right mentors and right advice at key stages of incubation. Bioincubators (and BIRAC) need to identify such people and enlist their support for mentoring start-up companies. The established biotechnology industries also need to form a support structure (e.g., a consortium or a corpus fund), wherein they can mentor or financially support (in exchange for equity) start-up companies. Lastly, a concerted effort needs to be made in manpower training and development, especially for industrial biotechnology. These should include post-finishing schools in biotechnology and entrepreneur development. Creating a large number of biotech start-ups is not the main requirement, as creating many successful start-ups with innovative technologies. So, identification of such start-ups, providing them long-term venture capital and mentoring them at key stages is more important than providing the investment for a large number of start-ups. Q: In the current situation, how many biotech start-ups can an incubation centre produce in a year, given the challenges in funding and infrastructure? Prof Guhan: Biotech start-ups will require a long time for incubation. A typical incubation centre can incubate 12-15 start-ups at any given time and probably graduate 2 -3 start-ups a year after achieving full maturity. Currently, one does not foresee any bioincubator graduating successful start-ups in the next 3 -5 years. Q: Tell us about the uniqueness of your incubation centre. Prof Guhan: The IIT-M Bioincubator has the unique advantage of being located in the IIT Madras Research Park which is a rich ecosystem consisting of a diverse array of technology companies, many of them being start-ups. Being adjacent to the IIT-M campus, this ecosystem provides a fertile ground for industry-academia interaction. Since different types of technology companies are being incubated at the Research Park, it provides an atmosphere for cross-fertilization of ideas, examples of diverse business models and opportunities for networking with entrepreneurs in different fields. Biotech start-ups have higher chance of success when they are incubated in such an ecosystem, rather than a specialized silo. Therefore, the IIT Madras Research Park model needs to be replicated across the country, by providing a diverse environment where there is rich academia-industry interaction and start-ups co-exist with established companies in different fields. Q: Briefly tell us about the success stories achieved at the centre? Prof Guhan: It is too early to talk about success stories. We have incubated just 4 companies. Q: Do you see a rise in the erection of number of biotech start-ups? Or is it dwindling? Prof Guhan: Three years ago, BIRAC initiated the establishment of a number of bioincubators and start-ups receiving the Biotechnology Ignition Grants (BIG).  Since then there has been an exponential increase in the number of start-ups at the incubation centres. So long the Government continues this healthy policy and industry also joins the act, these numbers will continue to rise. Q: Are you seeing any trends in biotech start-ups climate? Prof Guhan: Most of the biotech start-ups seem to be focused in the healthcare sector, especially diagnostics and medical devices. There are not enough start-ups in the area of industrial biotechnology, but there is a big market here. Q: Where can Indian incubation centres improve on? Prof Guhan: Indian incubators have to learn from the experience of successful incubators around the world, and yet learn to succeed under Indian conditions. The Government, academia and biotech industry need to come together and engage with them and provide them long-term support. Each incubator needs to develop its own niche areas of expertise and yet network strongly with other incubators for sharing infrastructure, ideas and mentors. This is only the beginning. We have a lot to learn and a long way to go, but patience and self-belief are the key ingredients along with substantial long-term investment. There is no fixed template available for success, but broad guidelines can be evolved over a period, which will perhaps improve success rates. There is a need for regular workshops and brainstorming in this area, which is largely missing. The bioincubators need to generously share ideas and infrastructure, as well as develop a strong network of mentors. ]]> https://biospectrumindia.com/news/97/6158/cardiac-devices-market-will-be-worth-26-million-by-2020.html https://biospectrumindia.com/news/97/6158/cardiac-devices-market-will-be-worth-26-million-by-2020.html Tue, 07 Jul 2015 16:31:22 +0530 The global cardiac monitoring and cardiac rhythm management (CRM) devices market is poised to reach $26,646.5 million by 2020 from $21,137.7 million in 2015, at a CAGR (Compounded Annual Growth Rate) of 4.7 percent from 2015 to 2020, according to a new report by MarketsandMarkets. The report highlighted that the ECG devices segment is expected to account for the largest share in 2015 in the Cardiac Monitoring devices segment. The ECG segment will also be the fastest-growing product segment during the forecast period. The defibrillator segment is expected to account for the largest share in 2015 in the CRM devices segment. Defibrillator segment will also be the fastest-growing product segment during the forecast period. The major end users of cardiac monitoring and cardiac rhythm management devices include home/ambulatory settings, hospitals, and other end users (research institutes and laboratories), says the report. Further, it mentioned that the home/ambulatory settings segment is expected to account for largest share in 2015 and will also be the fastest-growing segment during the forecast period. According to the report, Growth of the CM and CRM devices market is propelled by increasing incidences of cardiovascular diseases, technological advancements resulting in launch of products in the mobile cardiac telemetry segment, and emergence of private institutional nursing and home care. However, dearth of skilled healthcare professionals with expertise in electrocardiography and cardiac monitoring, and high cost of adopting advanced products are key factors limiting the growth of this market, it added.   North America is expected to account for the largest share of the CM and CRM Devices Market in 2015, followed by Europe. However, Asia is expected to register the highest growth rate during the forecast period, owing to the emerging markets such as China, and India.   ]]> https://biospectrumindia.com/news/97/6630/rohit-aggarwal-to-oversee-huntsman-india-operations.html https://biospectrumindia.com/news/97/6630/rohit-aggarwal-to-oversee-huntsman-india-operations.html Mon, 06 Jul 2015 15:58:55 +0530 Huntsman India, a global manufacturer ofdifferentiated chemicals has announced the appointment of Mr Rohit Aggarwal as the VP and MD of Huntsman India operations. He will be reporting directly to Mr Paul Hulme, president, Huntsman Textile Effects division. According to the press release, Mr Aggarwal will have corporate oversight over the company's India operations and focus on increasing the company's asset base, external partnerships and investment in India and the subcontinent. Mr Agarwal was previously the CEO, Asia Pacific for Louis Dreyfus. Prior to which he was with Huntsman as a strategoic marketing director in the advanced materials division before moving to textile effects as vice president. He has more than 20 years of experience in the chemical industry. Speaking on the appointment, Mr Paul Hulme said, "I would first like to thank Steve Stilliard for his valuable contribution throughout his stint at Huntsman India. He has displayed commendable leadership and keen sense of business insights in India which has positioned us for growth in India."     ]]> https://biospectrumindia.com/interviews/97/7216/bbc-to-fortify-technological-entrepreneurship.html https://biospectrumindia.com/interviews/97/7216/bbc-to-fortify-technological-entrepreneurship.html Mon, 06 Jul 2015 15:15:56 +0530 BBC, the soon-to-be launched biotech incubator by the combined efforts of Karnataka Biotechnology and Information Technology Services (KBITS) and Institute of Bioinformatics and Applied Biotechnology (IBAB), will be a hot-bed for nurturing and blossoming biotech start-ups in the country.Q: Tell us about the BBC's incubation model? Dr Jitendra: At Bangalore Bioinnovation Centre (BBC), the prospective incubatees are selected through a rigorous process. It is ensured that incubatees who are selected score high on innovation, social impact, team strength, and have a clearly laid out robust business model. These incubatees are provided with subsidized infrastructure/common equipment facility, focused mentorship, seed fund, access to venture fund, logistics for future growth plans/scale up, branding and networking support. BBC also plans to engage in building robust pipeline of technology entrepreneurs through different institutional means such as live business plan competition, and forming teams around IP protected technologies which are lying bare on shelves in research institutions. The centre is promoted by KBITS, which is a nodal centre of department of IT, BT and S&T, govt of Karnataka.   The Centre has received generous funding support from DBT, Govt of India. Structured as Section 8 not-for-profit company, it aims to spur innovation movement in Life Sciences in the State and beyond. Q: What's unique about BBC? Dr Jitendra: Uniqueness of BBC lies in its world class infrastructure, government support, governance structure (fully autonomous section 8 Co), linkages with academic institutions like IBAB and CHG, proximity to bio-cluster, and mentorship by Vision Group in Biotechnology chaired by none other than Dr Kiran Mazumdar-Shaw. Q: How can this model be replicated to kick-start biotech start-up boom in India? Dr Jitendra: Relevant department in every State should create such centres either through their own resources or through PPP mode. However, such centres should either be co-located with academic institutions or should be within an industrial cluster or both.   BBC has the advantage of being located within an upcoming Bangalore Helix Biotech Park. The park already has within its campus reputed academic institutions like IBAB and Centre for Human Genetics (CHG). Bio-Industry cluster building is under process. The model followed by Department of IT, BT and S&T, govt of Karnataka through its nodal Centre, KBITS and through BBC, to support bio-innovation, is a result of recommendations of Karnataka Vision Group in biotechnology under the leadership of Dr Kiran Mazumdar-Shaw, and members who are leaders in their own field. The Millennium Biotech Policy formulated by the govt of Karnataka does capture the vision and is being implemented through KBITS and BBC. Such model or variants according to local needs and resources need to be built and implemented in other states too. BIRAC like institutions and its schemes at State level is also an important requirement for scaling up the start-up movement in biotechnology in India.   Q: What are the key investments needed to achieve this? Dr Jitendra: Biotech start-ups require high gestation periods and are highly capital intensive, coupled with huge risk element, and thus there are high entry barriers. This entry barrier must be lowered through setting up of biotechnology incubators. BIRAC does have a scheme called Biotechnology Incubation Support Scheme (BISS), for supporting bio-incubators across the country but this is limited by participation by a host institution that already has an Incubation centre. There are bio-incubators hosted by many academic institutions, but still there is a need to create BBC like model incubation centres in each State. We need at least 50 such incubation centres, each having a capacity to incubate 40 high potential start-ups. Considering the cost of setting up one incubation centre as Rs 50 crore, we must have dedicated capital resource of Rs 2500 crore to achieve the target.   This number excludes the incubators that are already existing, but I think we must create an incubator support fund of this quantum. We also need to have dedicated funds for seed funding the incubatees through grants/soft loans and equity funds. Q: In the current situation, how many biotech start-ups can an incubation centre produce in a year, given the challenges in funding and infrastructure? Dr Jitendra: Incubation centres such as BBC can support 40 incubatees in its centre at any given point of time. It depends on the rate of new incubatees joining and old incubatees graduating to figure out an annual turnover of incubatees. Q: Briefly tell us about the success stories achieved at BBC? Dr Jitendra: The centre has just become operationally ready so true success stories are yet to come by. However, its host Institution IBAB has a stupendous track record of incubating start-ups for the last 12 years. It has Incubated companies such as Novozymes R&D, Microtest Innovations and Cellworks. Currently, there are many high potential incubatees being incubated at IBAB such as MIR Life Sciences, String, Privils, Denovo Bio, and Shodhaka amongst others. Since the new facility for bio-Incubation - BBC, is operationally ready, all these companies are expected to shift their operations to BBC. Q: Do you see a rise in the erection of number of biotech start-ups in Indian incubation centres? Or is it dwindling? Dr Jitendra: Number of incubation centres and number of start-ups are showing an increasing trend. This is owing to key role played by BIRAC, increase in awareness by different States towards setting up of incubation centre and overall positive outlook towards entrepreneurship. Q: Are you seeing any trends in the biotech start-ups climate? Dr Jitendra: Biotech start-ups boom is clearly discernible. BIRAC has played key role in propelling and fuelling the growth of Indian biotech start-ups and Incubation centres. Number of start-ups, number of incubators, government support and overall outlook toward entrepreneurship is positive side. Q: Where can Indian incubation centres improve on? Dr Jitendra: Incubation centres must cater to the needs of incubatees in terms infrastructure, instrumentation facility, policies for seed funding, and other relevant issues. Currently, there is a tendency to not engage start-ups /entrepreneurs while setting up the facilities, or formulating policies. So their representation must improve to create a real impact. Also, Incubation centres have not been institutionalized properly in the Indian scenario. Most of the incubators in India run on project mode, with no dedicated funds, no autonomy or no career paths for incubation managers. So, the activity runs on the fringes and never is a mainstream activity. ]]> https://biospectrumindia.com/news/97/7210/thermo-fisher-scientific-launches-heracell-vios-incubator-series.html https://biospectrumindia.com/news/97/7210/thermo-fisher-scientific-launches-heracell-vios-incubator-series.html Mon, 06 Jul 2015 13:14:31 +0530 Thermo Fisher Scientific has launched Heracell VIOS incubator series, ideal for academic research and pharmaceutical applications. "Reproducibility and contamination prevention are critical when it comes to sensitive cultures in order to ensure the integrity of your research," said Mr Doug Wernerspach, global business director, Thermo Fisher Scientific. He added, "Our new Heracell VIOS series leverage our long history of CO2 technology leadership with innovations, including our new THRIVE active airflow and proven decontamination that are critical for today's demanding cell culture applications." Incorporating the breakthrough THRIVE active airflow technology, the Heracell VIOS delivers a homogeneous culturing environment with fast recovery for unwanted variation. Designed to protect valuable cultures from contamination, the Heracell VIOS is equipped with ISO class 5 HEPA filters to protect against airborne microbes and particulates, Steri-Run, a fully automatic on-demand overnight 180°C sterilization cycle assures uniform 6-log high-temperature sterilization on all surfaces , Condensation-free chamber with covered, protected humidity reservoir, 100 percent pure copper interiors to provide lasting sustainability and easy maintenance. The incubators also has the intelligent iCAN touchscreen interface provides complete data visibility to monitor all incubator interaction, featuring on-screen menu prompts, error and usage monitoring, downloadable data logging with a standard USB, performance trend graphing and multiple language selection.     ]]> https://biospectrumindia.com/news/97/7175/thermo-fisher-introduces-a-new-microplate-reader.html https://biospectrumindia.com/news/97/7175/thermo-fisher-introduces-a-new-microplate-reader.html Mon, 06 Jul 2015 11:28:25 +0530 Thermo Fisher Scientific has launched a new multimode microplate reader with highly intuitive software delivers automated and versatile functionality to bioscience researchers performing a variety of microplate assays. The Thermo Scientific Varioskan LUX multimode microplate reader with new Thermo Scientific SkanIt Software is designed to simplify data acquisition and analysis and accelerate consistency and reliability in assay results. "The Varioskan LUX with SkanIt software builds upon our long history in pioneering microplate reader technology innovations," said Ms Hanna Grano-Fabritius, business director, Sample Preparation and Analysis, Thermo Fisher Scientific. She added, "With advancements including integrated smart control technology and automatic dynamic range selection, the Varioskan LUX is designed to simplify set-up while optimizing performance to deliver exceptional usability and data reliability." Varioskan LUX is equipped with smart safety controls to help keep research on track. These technologies include automated plate check, built-in shaker speed control, and automatic prime check and position sensors for the built-in dispensers, which are designed to identify and notify the user of potential errors that could compromise research. The Varioskan LUX's SkanIt software monitors and captures measurement data throughout the run to reduce the risk of wasting expensive reagents, samples and time. Varioskan LUX also offers an innovative automatic dynamic range selection feature that eases protocol set-up by eliminating the need for users to manually adjust sensitivity settings for each assay. The instrument automatically selects the optimal reading range based on signal intensity in the well, using settings to obtain maximum sensitivity.     ]]> https://biospectrumindia.com/news/97/3822/ppd-creates-a-pediatric-investigator-network.html https://biospectrumindia.com/news/97/3822/ppd-creates-a-pediatric-investigator-network.html Mon, 06 Jul 2015 11:07:57 +0530 Pharmaceutical Product Development (PPD) has formalized relationships with eight investigator sites as part of a Pediatric Investigator Network (PIN). The company has been established to further enhance its pediatric clinical development capabilities. This network, which includes world-renowned centers of excellence among its members, will provide biopharmaceutical companies with faster trial startup, more predictable patient enrollment and higher-quality data. PPD clients will also benefit from direct access to pediatric thought leaders and principal investigators across the globe. The PPD PIN currently includes Columbia University, New York; LSU Health Shreveport; National Children's Research Centre at Our Lady's Children's Hospital Crumlin, Ireland; National Institute for Health Research/Wellcome Trust Clinical Research Facility at Central Manchester University Hospitals NHS Foundation Trust, United Kingdom; NHS Research Scotland; Seattle Children's Research Institute; Schneider Children's Medical Center of Israel; and University of North Carolina at Chapel Hill Department of Pediatrics. The company plans to continue to expand this network by selecting and partnering with other centers of excellence worldwide that align with particular pediatric populations and research needs. "Drugs intended for use in children require specific evaluation in the age groups where such use is recommended in product labels. In recent years, we have seen an increased development in pediatric patients related both to regulatory imperatives and to increased development activity in rare diseases where children and adolescents constitute at least half of those affected," said Dr Mark Sorrentino, executive medical director and chair of PPD's pediatric practice area. He added, "Our network already has been working effectively with our clients to provide state-of-the-art clinical trial delivery across the globe. Building formal relationships with strategically important centers that have significant pediatric clinical trial expertise, a proven track record of superior quality and the ability to recruit pediatric patients demonstrates our commitment to partnering with our clients to bring life-changing medications to market faster and at less cost."       ]]> https://biospectrumindia.com/news/97/6389/thermo-fisher-presents-kingfisher-duo-prime-system-.html https://biospectrumindia.com/news/97/6389/thermo-fisher-presents-kingfisher-duo-prime-system-.html Fri, 03 Jul 2015 16:30:25 +0530 Thermo Fisher Scientific has launched a new nucleic acid and purification system, the new KingFisher Duo Prime system, builds upon the utility of its existing KingFisher Duo system, to help improve reproducibility and deliver high quality samples with less time and effort than traditional manual methods. With the KingFisher Duo, isolating DNA from 12 blood samples takes as little as 53 minutes and only requires a mere 15 minutes of hands-on time, compared to manual spin-column methods, which take up to 90 minutes of hands-on time. "Thermo Fisher Scientific continues to advance the functionality of its laboratory nucleic acid purification systems with the launch of the Thermo Scientific KingFisher Duo Prime system," said Ms Hanna Grano-Fabritius, business director, Sample Preparation and Analysis, Thermo Fisher Scientific. She added, "With the KingFisher Duo Prime system, researchers can achieve high quality samples while streamlining purification efforts." Thermo Scientific KingFisher systems are designed to isolate DNA, RNA and proteins from a variety of starting materials, including cell-free body fluids, blood, bacteria, cell cultures, tissue and plant samples. Low-to medium-throughput laboratories typically rely on manual processes to purify these samples. Manual purification, however, is a lengthy process involving multiple hands-on steps that can introduce the risk of human error and sample degradation. It has a built-in UV lamp that delivers easy and effective decontamination; and bar-code reader allows users to track samples directly in the internal software, an open platform allows researchers to optimize their workflow. Thermo Scientific KingFisher Pure reagent kits can be used for a complete, easy-to-use solution, while Thermo Scientific BindIt software enables users to make modifications and choose their own reagents. The automated magnetic bead technology, included in all KingFisher systems, is designed to enable reproducibility of each assay run from researcher to researcher and day to day. The new elution strip cap allows users to store their purified samples until they are ready to proceed with downstream analysis.       ]]> https://biospectrumindia.com/news/97/5990/quintiles-quest-diagnostics-jointly-launch-q2-solutions.html https://biospectrumindia.com/news/97/5990/quintiles-quest-diagnostics-jointly-launch-q2-solutions.html Fri, 03 Jul 2015 12:27:56 +0530 Quintiles and Quest Diagnostics on June 03, 2015 announced the launch of Q2 Solutions, their new combined clinical trials laboratory services organization. Q2 Solutions brings together the clinical trials laboratory operations of the two parent organizations to provide biopharmaceutical customers with the diverse capabilities and end-to-end services required in the rapidly evolving biopharmaceutical industry. The launch of Q2 Solutions is the result of the close of the previously announced global clinical trials laboratory services joint-venture transaction. Q2 Solutions is strongly positioned as the second-largest central laboratory services company in the world and provides services to customers across all segments of the biopharmaceutical industry - a group that includes all of the top-20 largest biopharmaceutical companies. If Q2 Solutions had been a standalone business in 2014, the organization would have generated approximately $575 million in annual revenues. Quintiles, the world's largest provider of product development and integrated healthcare services, owns 60 percent and Quest Diagnostics, the world leader in diagnostic information services, owns 40 percent of the two separate legal entities that comprise Q2 Solutions. "Q2 Solutions harnesses the complementary strengths, expertise and scale of two industry leaders," said Tom Pike, chief executive officer, Quintiles. "This new organization is built upon the strong foundation of its parent companies and provides customers with access to an innovative, progressive and responsive partner with the quality focus, global experience, and deep medical expertise integral to drug development." "Clinical laboratory services are central to advances in genomics, precision medicine and drug development. Q2 Solutions is well positioned to generate significant advances in these areas to benefit biopharmaceutical customers and patients," said Steve Rusckowski, president and chief executive officer, Quest Diagnostics. "This transaction is consistent with Quest's five-point strategy, because it allows us to maximize the value of our clinical trials assets in a capital-efficient manner while refocusing on our core diagnostic information services business."       The two parent companies also have entered into a period of exclusive collaboration to explore how to use their data assets to enhance areas such as clinical trial patient recruitment and retention, clinical trial design as well as companion diagnostic development and commercialization. Q2 Solutions' experienced management team comprises proven leaders from both Quintiles and Quest Diagnostics. The company's chief executive officer, Costa Panagos, most recently served as senior vice president and global head of Global Laboratories and Cardiac Safety Services at Quintiles. "Today is a milestone day for Q2 Solutions as well as the broader biopharmaceutical industry that we serve," said Panagos. "Q2 Solutions provides customers with industry-leading scientific expertise, a large global laboratory network, and a relentless focus on superior quality delivery to achieve better patient outcomes. These elements are foundational to Q2 Solutions' promise to help customers improve human health through innovation that transforms science and data into actionable medical insights." ]]> https://biospectrumindia.com/news/97/6039/pfizer-collaborates-with-nihr-clinical-research-.html https://biospectrumindia.com/news/97/6039/pfizer-collaborates-with-nihr-clinical-research-.html Fri, 03 Jul 2015 12:08:44 +0530 A new collaboration between the National Institute for Health Research Clinical Research Network (NIHR CRN) and Pfizer aims to see UK patients among the first to benefit from a new wave of innovative medicines development. For the first time, an entire national research network has been invited to participate in Pfizer's INSPIRE (Investigator Networks, Site Partnerships and Infrastructure for Research Excellence) programme. The NIHR CRN has agreed to form a strategic alliance with Pfizer as part of the company's INSPIRE programme. The collaboration is designed to facilitate research and innovation in the UK, and supports the Government's ambition to make the UK a world leader in life sciences. Through INSPIRE, Pfizer and NIHR CRN will share expert knowledge and experience of medicines research, to help bring more clinical trials to the UK and to help deliver the best results for patients in the NHS. In the UK today, Pfizer has 60 ongoing clinical trials across a range of therapeutic areas including oncology, cardiovascular, inflammation and neuroscience. Dr Freda Lewis-Hall, chief medical officer, Pfizer, said, "Many once-deadly illnesses are now manageable conditions thanks to innovative medicines, but there is still so much more to be done in the fight against disease. Through pioneering collaborations such as INSPIRE, we have the means to make faster progress and achieve more for patients. We are excited to be joining with the Clinical Research Network as part of our drive to bring a new wave of medicines and other treatments to patients in the UK and around the world." Further to this strategic alliance, Pfizer has selected the Greater Manchester Clinical Research Network to be part of the INSPIRE programme as a preferred location for clinical research. The Network will now be the 4th site in the UK to be selected by Pfizer as an INSPIRE site and means that patients in Greater Manchester could be among the first to receive innovative new treatments. Professor Martin Gibson, clinical director of CRN, Greater Manchester, said, "We are delighted to be chosen as an INSPIRE Site and look forward to working closely with Pfizer to enhance our research portfolio and bring new and better treatments to Greater Manchester patients. To be selected as an INSPIRE Site is recognition of Greater Manchester's highly motivated staff and world-class clinical research facilities. We look forward to a productive partnership that will benefit our patients and ensure Greater Manchester continues to be at the forefront of international clinical research."         ]]> https://biospectrumindia.com/news/97/7209/global-gamma-knife-market-to-expand-at-9-cagr-through-2020.html https://biospectrumindia.com/news/97/7209/global-gamma-knife-market-to-expand-at-9-cagr-through-2020.html Thu, 02 Jul 2015 13:59:44 +0530 Future Market Insights forecasts Gamma Knife market to gain traction in Asia Pacific (APAC) during the forecast period. Rising disposable income, greater awareness about available treatment options, and surge in medical tourism are anticipated to provide a boost to the Gamma Knife market in the region. FMI estimates Asia Pacific Gamma Knife market to expand at a CAGR of 10.5 percent during the forecast period 2015-25. The key players in the global Gamma Knife market include Elekta AB, Varian Medical Systems, and Huiheng Medical. FMI opines that owing to the consolidated nature of this market, these key players are focusing on developing new product offerings with advanced features.   The global radiation therapy equipment market was valued at US$ 4.61 bn in 2013. Stereotactic radiation therapy market, which comprises Gamma Knife and Cyber Knife, accounted for 10 percent share of the global radiation therapy equipment market in 2013. Increasing demand for non-invasive surgeries is one of the key factors driving the growth of the global Gamma Knife market. Effectiveness of radiotherapy in treating brain tumor and brain cancer is also anticipated to fuel the Gamma Knife market during the forecast period. Increase in the prevalence of neurological disorders, such as epilepsy, Parkinson's disease, and trigeminal neuralgia has led to increased demand for non-invasive treatment options.   FMI estimates Gamma Knife to emerge as a credible treatment option for neurological disorders during the forecast period. High cost is a key challenge for the Gamma Knife market. Gamma Knife machines cost around $4-5 mn and as such, their adoption remains limited, especially in the developing countries. According to FMI, other factors that can restrain the growth of Gamma Knife market during the forecast period include lack of trained professionals and low awareness among patients about the advantages of Gamma Knife. North America and Europe are the most lucrative regions for Gamma Knife market. These two regions collectively accounted for 57.5 percent share of the Gamma Knife market in 2014.   FMI estimates these two regions to remain dominant throughout the forecast period 2015-2025. The Gamma Knife market in North America was worth $46.3 mn in 2014 and FMI estimates it to expand at a CAGR of 7.5 percent through 2025 and reach a valuation of $102.8 mn. The market share of North America is anticipated to decrease from 29.2 percent to 25 percent during the forecast period. The Gamma Knife market in Europe is anticipated to expand at a CAGR of 7.7 percent during the forecast period. Its market share, which was 28.3 percent in 2014, is anticipated to drop to 24.5 percent by 2025. ]]> https://biospectrumindia.com/news/97/7149/strands-new-ceo-on-the-block.html https://biospectrumindia.com/news/97/7149/strands-new-ceo-on-the-block.html Thu, 02 Jul 2015 13:52:32 +0530 Strand Life Sciences, a global genomic profiling company that uses next generation sequencing technology to empower cancer care, today announced the appointment of Mr Scott A Storrer as chief executive officer. Mr Storrer will also be responsible for the continued development and marketing of Strand's precision medicine products in India. In his expanded role as now president and CEO, he will be responsible for all strategy, business expansion and worldwide operations effective immediately. Dr Chandru, who has served as Strand's chairman and CEO since its founding in 2000, will continue in his role as chairman of the board of directors. "Scott's twenty-plus years of executive experience leading and growing profitable businesses in the healthcare industry across the payer, provider and personalized medicine sectors will help Strand develop a strong presence globally," Dr Chandru said. Mr Storrer will also oversee the continued expansion of Strand Life Sciences' genomics software business. ]]> https://biospectrumindia.com/interviews/97/3496/worldwide-hospitals-are-the-poorest-users-of-it-services-and-india-is-no-exception.html https://biospectrumindia.com/interviews/97/3496/worldwide-hospitals-are-the-poorest-users-of-it-services-and-india-is-no-exception.html Wed, 01 Jul 2015 15:17:00 +0530 What is BioVedas' expertise?Medicine meets Management at every Bio Vedas' creation providing unique efficiencies in project cost, implementation, operations, productivity and profitability. Our team brings about ideation of new business models and innovative revenue models in healthcare delivery. We have developed a software called 'Digiderati', which is a business analytics tool for hospitals. Apart from this, our team has pioneered in establishing stand-alone and franchise-based clinics for diabetes. We are also turnkey consultants for hospitals and clinics. BioVedas also organizes healthcare events and expos. Your company claims to have an expertise in transforming clinical practice into a lucrative healthcare business for your clients. Could you elaborate on how BioVedas mediates this process? Bio Vedas is different from traditional armchair consultancy firms in that we have walked the talk in executing projects, managing clinics from ideation to inauguration and commercial success. Clinical practice is person dependent and many a times becomes personality dependent! De-linking ownership from operations and making clinical practice system dependent is the first key step to making healthcare delivery a lucrative business. How does BioVedas' healthcare business intelligence function? Bio Vedas has enabled the owners of hospitals to have direct access to the right data at the right time, even to those who are not IT savvy. Our team focuses on providing nuggets of wisdom to the hospital stake holders in a layman's language and terminology and thus reducing their dependence on IT and finance for information. Hospitals are the poorest users of IT worldwide and India is no exception. Transaction processing, Billing, Inventory are functions which use IT extensively. Few Hospitals have blanket coverage of IT of all departments. Fewer record their clinical data. Here lies the wealth and cutting edge for hospitals to improve their productivity and efficiency. BioVedas offers guidance in executing most hospital functions that require IT-support. BioVedas also has the experience of setting up paper-less, day care and chronic care clinics in India and other overseas countries. Could you name those countries and elaborate on the implementation? Initially, BioVedas helped in establishing several clinics in Chennai and then later the team worked to setup clinics in cities like Bangalore, Hyderabad, Madurai, Guwahati and Raipur in India and then we expanded overseas by offering guidance in setting up a clinic in Kuala Lumpur, Malaysia. Bio Vedas specializes in charting efficient workflows inside hospitals that saves money, space and turnaround time of patients. All clinics are running in profits and all the clinics cater to a wide audience making healthcare affordable, accessible and appropriate. What is the company's five-year plan?We plan to set-up 100 unique patient-centric chronic care clinics with the least turn-around time and transparency in transactions in every district headquarters. These clinics will be fully IT-enabled and cloud-based computing technology.   How do you perceive the growth of the healthcare market in Tamil Nadu and what kind of technologies are in trend? Innovative funding models of hospitals have made Tamil Nadu hospitals invest in technologies at par with the rest of the world. Innovations in hospital design, architecture, building material, workflow extensive use of IT, use of business analytics and professional management of hospitals will accelerate the growth of the healthcare industry in Tamil Nadu. There is a huge scope for innovative business models structured around meritorious but unsung heroes in medical profession who are at the bottom of the pyramid using unique JV models. Does Chennai have any edge over other cities as a preferred destination for investments in healthcare? If so, why? Chennai, according to me, is the healthcare capital of India. I would say corporatization of the healthcare system was pioneered in Chennai and the city's IT prowess has provided cutting-edge solutions in healthcare delivery market. With a huge NRI population the expectation of the market is world-class and Chennai has to be a step ahead of the rest of India. Availability of talent pool of doctors, paramedical staff and most importantly healthcare management professionals makes Chennai a preferred destination in modern healthcare delivery. ]]> https://biospectrumindia.com/news/97/7311/tech-mahindra-ambitious-towards-healthcare.html https://biospectrumindia.com/news/97/7311/tech-mahindra-ambitious-towards-healthcare.html Wed, 01 Jul 2015 13:57:41 +0530 Circle will provide access to its hospitals, clinicians and experience of running healthcare, allowing Mahindra to develop and adopt new technologies that improve patient care, operational delivery and to reduce costs for all parties. The project will be delivered by nth Dimension, a newly formed wholly owned subsidiary of Tech Mahindra in the UK. Mr Steve Melton, CEO, Circle, said: "This deal is a sign of the times. Healthcare has yet to see the tech-led disruption that we've seen in other sectors, but we think that is about to change. At the same time, there is a big push in UK government policy for transparency and better patient access to data - while the need for healthcare operators to be efficient has never been higher." He also added, "Tech Mahindra are a hugely respected firm with a track record of innovation. Its technology has made organizations across a vast range of sectors more connected, agile and efficient. We're absolutely delighted our partnership with Tech Mahindra will support us to grow our business and improve our competitiveness through the adoption of new technologies."   Mahindra will develop new IT solutions for Circle's hospitals and NHS management contracts - giving its facilities access to state-of-the-art technologies that it has deployed in other sectors such as the telecoms sector, supporting the adoption of mobile healthcare solutions. Both partners have ambitious growth plans for the healthcare sector, focusing in the first instance on the creation of a new state-of-the-art hospital in Birmingham that will allow for a wide range of innovations to be adopted within the design phase. Additionally, Mahindra will support Circle in developing its innovative MSK service across Bedfordshire, providing patients with the ability to book their MRI appointments from their mobile phones and GPs viewing scans and reports from their mobile devices. Mr Rajib Bhattacharya, Vice President, Tech Mahindra said: "....Our plans are to focus on creating and adopting new technologies from around the world into the UK healthcare market which is facing unprecedented pressures on its finances and we felt that Circle were the best partner to work with....." ]]> https://biospectrumindia.com/news/97/4339/family-planningtelemedicine-win-at-camtech-india-jugaad-a-thon.html https://biospectrumindia.com/news/97/4339/family-planningtelemedicine-win-at-camtech-india-jugaad-a-thon.html Wed, 01 Jul 2015 10:39:16 +0530 More than 300 participants, industry mentors, organizers and volunteers came together at the second CAMTech INDIA Jugaad-a-thon to co-create and develop affordable health technologies that address reproductive, maternal, newborn and child health (RMNCH) in India. Organized in partnership with Lattice Innovations and hosted by GE Healthcare India at the John F Welch Technology Center in Bengaluru, the Consortium for Affordable Medical Technologies (CAMTech) at Mass General Hospital's Center for Global health called on innovators from across India, Africa and the US. Through this USAID-sponsored initiative, a diverse group of clinical, engineering and business participants convened around one main goal, improving the lives of women and children in India. "We believe that co-creation is the future of health care innovation, where clinicians sit side-by-side with engineers, entrepreneurs and industry to develop disruptive and impactful solutions. This year's Jugaad-a-thon brought that diversity of stakeholders in India together to show that you can accelerate the whole process of innovation," said Ms Elizabeth Bailey, CAMTech's Director. The Jugaad-a-thon (derived from the Hindi word "jugaad" meaning an innovative fix or work-around), invites some of the world's brightest minds to collaborate over a 48-hour period and develop solutions to identified clinical challenges through an open innovation platform. Prior to the Jugaad-a-thon, CAMTech INDIA held a Clinical Summit with clinicians, healthcare workers, government public health experts and patients from around the world to identify and discuss pressing maternal and child health challenges, as well as best practices in delivering care. The Summit also included a Technology Showcase for early-stage and newly-marketed medical technologies that aim to improve quality and access for RMNCH in India. From low-cost female contraceptives to novel ways to deliver oxygen to remote health centers to gamification of family planning education, this year's event saw 65 innovations developed, a record number from CAMTech's hack-a-thons. "In this year's Jugaad-a-thon, we gave the participants three challenges that represented three of the most pressing needs in the area of maternal and infant care. The record number of quality ideas generated at Jugaad-a-thon clearly validates our belief that the way forward for innovating meaningful and impactful healthcare solutions is by co-creating these solutions with all stake holders of the healthcare eco-system," said Mr Milan Rao, president and CEO, GE Healthcare South Asia. Participants worked around the clock to pitch healthcare problems, form teams, prototype solutions, and develop business models before presenting their ideas to a panel of judges from public health, engineering and business, reflecting CAMTech's cross-sector approach to innovation.   This year's event awarded monetary prizes to winning teams in several categories, including: USAID Grand Challenge Award: Family Planning and Reproductive Health: Team Trust+ won this prize for developing of a mobile platform for adolescents and adults that encourages open and effective communication about safe sex and family planning. CAMTech-USAID Awards: CAMTech and USAID awarded prizes to the top three teams across all categories: Team Slow Forward, an effective video consultation for rural areas with low bandwidth took first place; Team Peekaboo, an interactive gaming application that aids in identifying vision impairment for children, won second place; and Team Shakthi Ki Yukthi, a low-cost female contraceptive tool, took the third prize. GE Healthcare India Awards: GE sponsored three challenges and awarded prizes to the following teams: Nitrobooster, which developed a cost-effective and steady supply of nitrous oxide for surgeries; O2-Matic, a low-cost method for oxygen production to address unpredictable availability of medical gases in limited resource settings; and Aawaazz, an affordable device that screens for hearing impairment in infants in under-served communities. MSD for Mothers (known as Merck in the US and Canada) Awards: These awards were given to MOM (Maternity over Mortality), which aims to reduce the culture time involved in the diagnosis of maternal sepsis, and Team Slow Forward. In addition to this year's winners, Jugaad-a-thon participants will have the opportunity to win a special post-Jugaad-a-thon award from FICCI and Terumo India for the top two innovations that make the most progress 30 days after the event.         ]]> https://biospectrumindia.com/features/97/7560/indias-iconic-biotech-parks-and-incubators.html https://biospectrumindia.com/features/97/7560/indias-iconic-biotech-parks-and-incubators.html Tue, 30 Jun 2015 14:57:41 +0530 The dawn of the new millennium paved the way for revolutionizing information technology, which changed the way humans lived, communicated, and did business. Coupled with that, Biotechnology, in particular, is altering the course of healthcare and the way diseases are diagnosed and treated. It is expected that in the coming years, there will be an increase in biotech parks and incubation centers in India, where budding entrepreneurs and small firms will find the support to thrive. Here is an overview of India's iconic Biotech Parks and Incubators. Biotech Parks  Genome Valley Conceived in 1999, Genome Valley (GV) is located in the Northern periphery of Hyderabad State in Southern India. It comprises of knowledge parks, special economic zones (SEZs), multi-tenanted lab space buildings, incubation facilities, office spaces and support facilities. It has an array of companies in the realm of agri-biotech, CROs, biopharma, vaccine manufacturing, regulatory and testing.   The cluster has over 100 lifescience companies. The multi-tenanted lab space buildings and incubation facilities provide growth to small, medium, and large enterprises, including start-ups. Genome Valley is also known as the 'Vaccine Hub of India', since leading vaccine producers like Biological E, Bharat Biotech and Globion Bio are within the cluster, along with Shantha Biotech and Indian Immunologicals. It has two prominent knowledge parks - Alexandria Knowledge Park and IKP Knowledge Park. IKP Knowledge Park The IKP knowledge park is India's innovative lifescience park facilitating business-driven R&D for more than 10 years now. Spread across 200 acres in genome valley, Hyderabad, in the State of Andhra Pradesh, the park's main objective is to build an environment for innovation and growth of lifesciences. The park boasts of ready-to-use multi-tenanted modular wet laboratory blocks (innovation corridors) with in-built flexibility around common, shared facilities and support services, as well as developed land for customized R&D facilities. All the operations and maintenance of IKP is ISO 9001-2008 certified. The infrastructure services include electricity, telecommunication, refuse disposal, conference facility, meeting rooms, cafeteria and gymnasium. The IKP knowledge park has promoted 65 companies so far, and is currently associated with 47 of them. The park has been receiving support from the State and the Central governments in India. The park has also received partial funding from National Science and Technology Entrepreneurship Development Board (NSTEDB), Department of Science and Technology (DST) to establish the Life Science Incubator, and from the Department of Scientific and Industrial Research (DSIR), Government of India, to establish a Virtual Information Center. The park is supported by the Department of Biotechnology (DBT) for augmenting its lifescience incubator facilities. Biotechnology Industry Research Assistance Council (BIRAC) has supported IKP with an ignition grant. TICEL Bio Park Situated in the Southern Indian State of Tamil Nadu, Chennai-based TICEL Bio Park is a 5-acred landmark lifesciences biotech R&D park, which is a unit of Tamil Nadu Industrial Development Corporation (TIDCO). The park's co-promoters include Indian Bank, Karur Vysya Bank and Indian Overseas Bank. The park's design and technical parameters were provided by Cornell University, USA. The park has varied facilities including a bioresource center which is under consideration. It also has a tenancy area, and training centers. The TICEL Park was set up with a capital of US $12.5 million and has national and international clients. Bio360 - Life Science Park Bio360-Life Science Park is Southern Indian State Kerala's upcoming lifesciences park, focusing on facilitating the Bio-IT and Nano technology sectors in India. The park is located in the village of Veiloor, Thiruvananthapuram, and will be a geographic cluster of biotechnology, nanotechnology and lifesciences industry, research institutions and sci-tech academia. The park offers space for large and integrated Bio-IT companies to set up their organizations, and has ready to occupy built-up modules focusing on human health. The park's unique selling point will be its Incubation Center (IC) and the Technology Development Center (TDC). The incubation center will provide critical infrastructure facilities to start-up Bio-IT companies and assist them in the initial years (incubation period) until they are self-sustainable. According to the park, once the start-up matures, it will move out and venture on its own. The Technology Development Centre (TDC) will facilitate small and medium-sized IT players, inventors and entrepreneurs in the State to start, expand or make their business more competitive in the marketplace. To begin with, a state-of-the-art, new generation biotechnology incubation centre is being promoted by Kerala State Industrial Development Corporation (KSIDC), and Tropical Botanic Garden and Research Institute (TBGRI) in the park. Nationally and internationally-renowned R&D institutions in lifesciences and biotechnology sector including Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Regional Cancer Centre (RCC), Rajiv Gandhi Centre for Biotechnology (RGCB), and National Institute for Interdisciplinary Science and Technology (NIIST) have also come together along with KSIDC and TBGRI. The project cost of the incubation center, excluding the land, is estimated at INR 300 million, which includes INR 180 million for the first phase. The incubation center will offer the technical know-how of nationally and internationally reputed R&D institutions in the lifesciences and bio-technology sector. Golden Jubilee Biotech Park for Women Society The Golden Jubilee Biotech Park for women was established with a mission to provide opportunities for professionally qualified women, to pursue a career of remunerative self-employment through the organization of environment-friendly biotechnological enterprises. The biotech park and its activities are closely related to the objective of building a rural-urban linkage. The park is situated in Siruseri village in Kanchipuram in the Southern Indian State of Tamil Nadu, and surrounded by other villages like Pudupakkam and Mambakkam. The raw materials required by the enterprises within the park are directly sourced from the farmers. Thus, the park provides a platform for utilizing the produce of rural farmers, and converting them into products for the urban market. The M S Swaminathan Research Foundation plays a key role in linking the farmers and their produce with the biotech park through self-help groups. The park has developed lab facilities for providing quality testing and training programs. It has also been successfully conducting short and long-term training programs for college students as a means of providing much needed hands on experience, and to generate revenue streams for the park. The biotech park plans to develop this into an entrepreneurial facility. Women scientists with managerial skills and capable of making small-scale investments, are to independently take up the functioning of the lab. Guwahati Biotech Park Situated in the State of Assam in India, the government of Assam has allotted land measuring 17 acres to Guwahati Biotech Park. Facilities include eight modular laboratories, specialized and support facilities. Interim facilities have been created at Indian Institute of Technology (IIT), Guwahati, in a building rented out to the state government for the incubator. Bangalore Biotech Park Currently, the park is under construction with 25 incubation suites ranging from 200 sq ft to 700 sq ft. Located in the Southern State of Karnataka, there is a plan to build a common instrumentation facility, mammalian and plant tissue culture, dark room, cold room, utilities, animal house, chemical store, cafeteria, meeting rooms, and conference rooms. KINFRA Biotech Park The Biotechnology Incubation Centre (BTIC) by Kerala Industrial Infrastructure Development Corporation (KINFRA) has been set up at Ernakulum, to provide incubation facilities to industries. It is located in the Southern State of Kerala. The labs are equipped with commercial facilities and six units are under construction. A 20 acre land is available for lease to companies. A Project Advisory Committee (PAC) would help the Project Implementation Committee (PIC) in the selection of equipment, infrastructure provided to each lab and for the selection of tenants in BTIC. Bio Pharma-IT Park The facility is being developed at Andharua in Bhubaneswar, in the Eastern State of Odisha, on a land parcel of 64.61 acres. The park area has been demarcated and walled off, and utilities have been provided. The construction of the building for the incubator is yet to begin. Focus is on the training program and on building a good manufacturing practices (GMP) quality facility. Biotechnology Incubation Centre The Centre is located up in the Northern India. A few years ago, a biotechnology park project was sanctioned to the Department of Biotechnology (DBT), government of Himachal Pradesh, Shimla. The government of Himachal Pradesh constituted an executive committee and Society for Promotion of Biotechnology and Biobusiness (SPBB) as a nodal agency for implementing the Biotech Park Project. Establishment of the Biotechnology Park is under way and discussions were held for setting up of infrastructure and for identification of prospective investors. Lucknow Biotech Park (LBP) The Uttar Pradesh-based LBP started operations in 2006. The park has generated employment for about 200 people. To date, 7-8 companies have graduated from the incubator and another nine companies are under incubation. The park has National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation for its analytical facilities and provides service to many agro-industries in the region. The plant tissue culture facility is also certified under DBT-BCIL certification program. The park has an extraction unit, a bioinformatics unit and a bio-fuel unit. The park is also hosting HRD programs for research scholars and a biotech finishing school. Punjab Biotechnology Park Located in Dera Bassi at Chandigarh, in the Northern State of Punjab, it focuses on technology transfer, collaborative research, exchange of scientific manpower and company-to-company business relationship in agricultural and environmental biotechnology and bioprocessing. It has all the basic facilities including water, electricity, with tax exemption office, R&D lab, and sewage treatment facility. Shapoorji Pallonji Biotech Park This park is located at Shamirpet in the Southern State of Hyderabad. The park is a joint venture between the government of Andhra Pradesh and Shapoorji Pallonji Co Pvt Ltd. It is spread over 300 acres. It has a state-of-the-art infrastructure for lifescience research, particularly for biopharmaceuticals, training and manufacturing activities, with all basic facilities of road, power, space, and telecommunications. It has attracted more than 15 corporate clients who are interested in setting up their R&D centers. Jalna Biotech Park Located in the city of Aurangabad, in the Western State of Maharashtra, this park was set up by Wockhardt. It consists of a 107 hectare land. It has manufacturing facilities for active pharmaceutical ingredients, biopharmaceuticals, R&D center, effluent treatment plant, a corporate office, warehouse and a residential and recreational complex. It provides employment to an estimated 2000 people. Proposed Biotech Parks: â–  Biotech Park, Konark, Chandrabhaga, Odisha.â–  Marine Biotech Park, Ganjam, Odishaâ–  Boranda Biotech Park, Jodhpur, Rajasthan. â–  Herbal Pharma Biotech Park, Betma, Indore, Madhya Pradesh.â–  Ansals API Biotech Park, Lucknow, Uttar Pradesh.â–  Pantnagar Biotech Park, Haldi, Uttaranchal.â–  Solan Biotech Park, Himachal Pradesh.â–  Jogindernagar Biotech Park, Shimla, Himachal Pradesh. Incubators Startup Oasis Located in the Northern India, Startup Oasis is a Jaipur City-based incubation center, set-up at the joint initiative of RIICO, Rajasthan's premiere industrial promotion organization, and the Center for Innovation, Incubation and Entrepreneurship (CIIE) at Indian Institute of Management (IIM) Ahmedabad. Venture Center The BioIncubator at Venture Center, located in the West Indian city of Pune, aims to nucleate and nurture technology and knowledge-based enterprises leveraging knowledge in the areas of biotechnology including biopharma, agri-biotech, industrial biotech, and clean technology, biomedical engineering, devices, diagnostics, biomass value addition, renewable fuels, chemicals, materials, bioinformatics, biomedical services and related disciplines. NCL Innovations NCL Innovations was founded in 2007 as a new resource center of the National Chemical Laboratory, located in Pune city, to champion the cause of technology innovations within the organization. Indian Angel Network (IAN) Based in the Northern city of New Delhi, India, IAN in an equity-based business incubator center that gives priority to ventures in the areas of healthcare, gaming and animation cloud computing, retail, mobile VAS, media and entertainment, alternative energy, education and clean technology. It has been established with the support of the National Science & Technology Entrepreneurship Development Board (NSTEDB) and the Department of Science & Technology (DST) of the government of India. GSF M-Accelerator Started in 2012, India-based GSF M-Accelerator is a specialized accelerator program for mobile start-ups. Functioning as a 'super-accelerator' by design, GSF M-Accelerator offers founders four months to make the kind of progress ordinarily accomplished in six to eight months.   ]]> https://biospectrumindia.com/features/97/7927/karnataka-state-asias-hottest-biotech-hub.html https://biospectrumindia.com/features/97/7927/karnataka-state-asias-hottest-biotech-hub.html Tue, 30 Jun 2015 12:51:00 +0530 India as a country ranks as the second most favored biotech destination next to China in the Asian continent. The Southern State of Karnataka in India has always been in the forefront of technological advancements in the global scientific arena. Notably the city of Bangalore, usually dubbed as India's Silicon Valley, has been crowned as the thriving hot bed for Information Technology and Biotechnology sector. Karnataka is a host to almost 60 percent of all biotechnology companies in India, followed by other States including Maharashtra, Andhra Pradesh and Tamil Nadu. Most of these companies have set up their R&D base in Karnataka, thereby attracting billions of dollars' worth investments every year.   Bangalore is also a teeming place for India's best innovative biotech startups. In fact, Karnataka recorded the highest R&D spend in Southern India than any other State. The State also boasts of having strong research base, industry-academia nexus, top universities and institutes tie-ups, highly skilled workforce, robust infrastructure, raining FDIs, industry associations, and the government's supportive policy framework for prominently establishing Biotechnology in the State. Here is an exclusive peek into the State's world-class, state-of-the-art Biotech Parks. Helix Biotech Park in Bangalore With a whopping investment of INR 350 crore, Helix Biotech Park in Bangalore is a joint initiative between the department of IT, BT, S&T and Alexandria Real Estate Equities, USA. The park will be known as Alexandria Knowledge Park.   Spread over 52 acres, the park aims to support biotech units with common infrastructure. The biotech incubator is spread over 10-15 acres in the park. The park will offer incubation facility, lab and commercial space, common instrumentation facility, a business center, commercial and recreational areas, high-end computing facility, pilot plant, medical sample repository, and a gene bank. Agri-Biotech Park in Dharwad In 2010, erecting an agri-biotech park in the District of Dharwad was proposed by Karnataka State with an investment of INR 80 crore, employing about 5000 workforce. Spain's Savaia Biotech and University of Massachusetts, USA, together are involved in the development of the park.   The park will be built in 30 acres of land at the University of Agricultural Sciences-Dharwad (UAS), Karnataka. The park would be a centre for agriculture R&D, gene construction and pest management. Also transgenic plants of various crops is planned to be cultivated at the park. Neutraceutical and Phytopharmaceutical Park (N2P2) in Mysuru The park is planned with an investment of INR 103 crore, employing 5000 people. The park will pioneer in various R&D in the areas of nutrition and phytopharmaceuticals or medicinal plants.   Animal House (Vivarium) in Bidar The Animal House (Vivarium) is upcoming in the District of Bidar in Karnataka, with an investment of INR 40 crore. It is expected to provide employment to over 3000 professionals. Standing on 20 acres of land, the centre will be a hub for conducting R&D in disease diagnosis, vaccine production, bioinformatics, embryo transfer, and stem cell techniques. Marine Biotech Park in Mangalore In 2010, the proposal to set up Marine Biotech Park in the District of Mangalore, Karnataka, was put forth, with an initial investment of INR 60 crore, offering employment to more than 3000 workers and professionals. ]]> https://biospectrumindia.com/news/97/6287/asrt-foundationtoshiba-launch-the-safety-first-grant-program.html https://biospectrumindia.com/news/97/6287/asrt-foundationtoshiba-launch-the-safety-first-grant-program.html Mon, 29 Jun 2015 11:40:31 +0530 To help improve technologist safety in radiology, the American Society of Radiologic Technologists (ASRT) Foundation and Toshiba America Medical Systems, have partnered to launch the Safety FiRsT grant program. The Safety FiRsT program is a new component of Toshiba's focus on putting its customers first by providing 360 degrees of coverage, guidance and expertise, enabling ASRT member institutions to fund creative programs aimed at improving safety for radiological technologists. The ASRT Foundation and Toshiba's Safety FiRsT program will award two ASRT members a grant of up to $7,000 each for the implementation of a radiologic technology safety program or creative idea aimed at improving technologist safety. These facilities will then implement the program and share best practices. "The Safety FiRsT program grants will help facilities to ensure the safety of their technologists and meet their business needs simultaneously," said ASRT Foundation chairman of the Board, Mr Steve J Hardy. He added, "Assistance that helps purchase new equipment for technologists, create new training programs or implement other inventive ideas to improve safety allows the facilities to focus on providing the highest quality care." "Safety goes beyond lowering radiation dose; it is an encompassing concept that requires constant refinement, guidance and expertise. Developing this new grant program allows hospitals to further their pursuit of establishing programs that meet the goals of the Triple Aim by improving individual and population-wide care," said Mr Satrajit Misra, vice-president, Marketing, Toshiba.   The ASRT Foundation and Toshiba Safety FiRsT grants are funded by an educational grant from Toshiba America Medical Systems.   ]]> https://biospectrumindia.com/news/97/7163/take-solutions-gets-us-patent-.html https://biospectrumindia.com/news/97/7163/take-solutions-gets-us-patent-.html Mon, 29 Jun 2015 11:26:05 +0530 TAKE Solutions, was awarded a patent by the United States Patent and Trademark Office (USPTO) for its Method for Optimizing Clinical Data Standardization. This process leverages TAKE Solutions' Clinical Accelerators to reduce the time taken to standardize trial data by over 50 percent (when compared to standardization without the accelerators), thus reducing time to market. At the heart of the patented Clinical Data Standardization Process are TAKE Solutions' Clinical Accelerators, a set of macros that accelerate the Clinical Data Standardization process where raw data from clinical trials is standardized and transformed into CDISC SDTM format. The process includes various pre-defined steps that convert raw data into tabular datasets. This enables regulators to easily understand the data, as well as enables easy analysis of trial data. This process is delivered by Navitas, the Life Sciences arm of TAKE Solutions. The Clinical Data Services team offers its clients the benefit of our deep domain expertise in Clinical Data solutions including, Clinical Data Standardization, Clinical Data Management, Statistical Programming, and Data Standards.     ]]> https://biospectrumindia.com/interviews/97/7113/vcs-keen-to-invest-in-new-ips-and-products.html https://biospectrumindia.com/interviews/97/7113/vcs-keen-to-invest-in-new-ips-and-products.html Sun, 28 Jun 2015 08:49:00 +0530 The Indian pharmaceutical industry is growing at a burgeoning rate and there is a huge movement in terms of import and export. The biotechnology sector on the other hand, is a significant sector enhancing India's global profile, contributing to the growth of the economy. The ever growing pharmaceutical industry is acutely temperature and time sensitive. Cold supply chain acts like a backbone for the pharma industry.  In his exclusive interview to BioSpectrum's Raj Gunashekar, Mr Ranjan Jain, managing director, Elanpro, a cold chain solutions provider, shares that India's cold chain industry is still evolving, disorganized and operating below its capacity. He also talks about some of the most valuable insights on India's cold chain supply chain industry, investment drivers, the future challenges and how major players are geared up to solve them. Q: What key trends are shaping up the cold chain industry? A: The biotech and pharma sector is evolving very fast with India becoming major hub for clinical trials and production of vaccines and injectibles. This activity is being driven by a combination, where the biopharma industry is going more towards biologics, and the global industry's push into emerging markets   More and more brands and pharmacy stores are fast adapting the change and are moving towards having appropriate equipment. One significant change is the consumer shift from domestic refrigerators to pharma refrigerators. Q: How are VC investments in this industry? A: VCs are keen to invest where they see new IP or new products. Indian cold chain industry creates neither; hence the interest level is still low. IP creation in cold chain is both money and time intensive. However, as the market grows bigger, it may witness some growing interest in the near future. Indian commercial refrigeration industry is also highly fragmented with a large number of small and unorganized players who may not actively seek out VCs intervention. Q: Are investments in cold chain risky? A: All businesses are risky, especially which requires capital intensive infrastructure. However, India has a higher than expected demand for customization but still low volumes. Erratic electricity supply also increases the cost of running the machine. India is at a very nascent stage of cold chain storage in the life sciences field with enormous opportunities, and therefore there is virtually zero risk on demand side. Moreover, as Indian consumers are still very price conscious, the usage of high-end products is still not very high. Although, there is a lot of potential in this sector yet a lot of investors are shying away from taking the risk. It is primarily the lack of infrastructure like roads, proper distribution chains and the high cost of setting up a cold storage unit that has kept the investors at a distance. Q: Can you mention a few VCs who have invested much? A: As of now no such investment has happened though we have seen some investment by foreign multinationals in the manufacturing segment. Q: How are biotech and pharma industries driving the Indian cold chain market? A: It is a big responsibility to have a regulatory supervision and to maintain the efficacy of the drug throughout the supply chain. Complex compositions, limited shelf-life, large number of intermediaries and statutory compliances pose as challenges in maintaining the quality of drugs. Strict hygiene, safety and quality measures need to be incorporated to keep the medicines fit for use. Since the stored items are of high value they demand models with automatic defrost that can deliver controlled temperatures from +4 to -20, -40, -80 and -150°C. Q: What are the booming opportunities? A: India's cold chain industry is still evolving, not well organized and operating below its capacity. The contribution of organized players is not very high in the widely fragmented Indian cold chain market. But, India offers great market potential for cold chain logistic solution providers, including refrigerated transport. Besides the regular manufacturing sector, the opportunities are bigger in pharma retail and healthcare equipments. The biggest change which India will witness will be the consumer transition. What is also raising demand for cold chain services is not only an increase in the movement of perishable horticultural and agri produce, but also pharmaceutical, dairy, poultry and meat product exports, as well as the fast-growing quick service restaurants. With the increased needs and understanding, people using domestic refrigerators will move to pharma coolers in local pharmacy shops as well as research labs. Similarly, various R&D Labs are also shifting to high-end, frost-free, low temperature freezers from the outdated direct cool technology. The other significant development is the use of solar power driven freezers which will obliterate the currently used ice lined refrigerator (ILR) that are not only very expensive but still don't solve the problem in far off areas where power supply is an issue. Q: Any challenges that you want to point out? A: The pharma retail industry faces similar challenges as other retail industries do. Although a temperature controlled environment is essential to maintain the efficacy of various drug, a vast consumer base is still relying on domestic refrigerators wherein the temperature varies from (-) 4°C to 10°C. One of the biggest challenges is the servicing of equipments which requires higher attention, detail and more time. Availability of unskilled and untrained service technicians coupled with immense pressure to reduce customer's cost and time has forced users to switch to low-cost service providers, and service providers resort to short cuts to save time. This leads to more failure in the long run. Q: How are companies tackling those challenges innovatively? A: Since it is not a core business, there is very little innovation. Some companies maintain their own service team. Few insist on buying expensive equipment. Q: Where do you see major competition? Who are the competitors? A: Different players cover different segments of cold chain. While companies like Thermo, Sanyo and Haier compete with us on low temp segment, there is very little competition in the solar freezer or pharma cooler and ice flake machines. Q: Who are the top players in the industry? A: While Blue Star, Voltas, Rinac, lead the industry in cold room segments, we lead along with Vestfrost in low temperature and pharma coolers. Q: What are the demands from biotech and pharma companies? A: Developing economies like ours are witnessing an increased demand for generic pharmaceutical products. In this scenario, temperature-sensitive healthcare transportation with the use of temperature tags on products becomes a critical need. The bulk of the demand is for automatic defrosting models of refrigerators and freezers in small sizes. Bulk of the freezers are required in (-) 20°C. Q: Where is this industry lacking compared to the West? A: The cold chain industry in India is still at a very nascent stage thus evolving in India. Due to a large gap in demand-supply conducive to small unorganized service providers, users have developed captive resources. High operational costs, restrictive land use and lack of logistical support are some of the differentiating attributes of cold chain industry in India. I firmly believe that there are 3 major areas of concern: Scale of size needs to be reached to go to the next level Demand for high-end equipment is low Service standards are still below than those in western countries largely due to scant population of equipment and erratic power supply. Q: How prepared are our airports to handle temperature-sensitive medicines? A: The sensitivity for healthcare supplies needs to be developed. It will probably happen if we export anything which requires cold chain. We now have large number of companies which have started specializing in cold chain movement which are led by global giants like TNT. Airports are still not well equipped, but things are changing rapidly. Q: Any thoughts on cold chain regulatory issues? A: We all are hoping for quick implementation of cold chain norms as unfortunately Indian food and retail industry uses better equipment than pharma industry in the absence of any regulations or laws. Q: How has Elanpro performed financially? A: We have grown very well over the 5 years with revenues doubling every second year. Elanpro has now become a respected name in the field of refrigeration equipment for life sciences, and the growth in this segment is expected to be in the range of 25 to 30% YOY basis for next few years. Q: How do you plan to expand? A: We are expanding our sales and distribution reach continuously. We are also evaluating few strategic growth options. We are continuously exploring new technology which can be adopted to suit Indian conditions and applications. Q: How do you see the future of cold chain in India? Any growth numbers/estimation? A: In the immediate future the cold chain business can expect high double digit figure growth for the next few years. We expect the new norms to be adopted by the government which will make it imperative for strict compliance in maintaining cold chain. This will give major boost for cold chain expansion. Furthermore, with focus in India shifting to manufacturing, we are anticipating very large investments in pharma segment, both in manufacturing as well as R&D, which will again enable big impetus for cold chain growth. ]]> https://biospectrumindia.com/news/97/6024/broad-institute-google-to-analyze-genomics-data.html https://biospectrumindia.com/news/97/6024/broad-institute-google-to-analyze-genomics-data.html Fri, 26 Jun 2015 12:28:28 +0530 Broad Institute of MIT and Harvard are teaming up with Google Genomics to develop a computing infrastructure that will help store and process enormous datasets, as well as create tools to analyze such data in biomedical research. As a first step, Broad Institute's Genome Analysis Toolkit, or GATK, will be offered as a service on the Google Cloud Platform, as part of Google Genomics. The goal is to enable any genomic researcher to upload, store, and analyze data in a cloud-based environment that combines the Broad Institute's best-in-class genomic analysis tools with the scale and computing power of Google. GATK is a software package developed at the Broad Institute to analyze high-throughput genomic sequencing data. GATK offers a wide variety of analysis tools, with a primary focus on genetic variant discovery and genotyping as well as a strong emphasis on data quality assurance. Its robust architecture, powerful processing engine, and high-performance computing features make it capable of taking on projects of any size. GATK is already available for download at no cost to academic and non-profit users. In addition, business users can license GATK from the Broad. To date, more than 20,000 users have processed genomic data using GATK. The Google Genomics service will provide researchers with a powerful, additional way to use GATK. Researchers will be able to upload genetic data and run GATK-powered analyses on Google Cloud Platform, and may use GATK to analyze genetic data already available for research via Google Genomics. GATK as a service will make best-practice genomic analysis readily available to researchers who don't have access to the dedicated compute infrastructure and engineering teams required for analyzing genomic data at scale. An initial alpha release of the GATK service will be made available to a limited set of users.   "Large-scale genomic information is accelerating scientific progress in cancer, diabetes, psychiatric disorders, and many other diseases," said Mr Eric Lander, president and director of Broad Institute. He added, "Storing, analyzing, and managing these data is becoming a critical challenge for biomedical researchers. We are excited to work with Google's talented and experienced engineers to develop ways to empower researchers around the world by making it easier to access and use genomic information." "Broad and Google share a culture of collaboration and open access to data. Google Genomics is helping scientists make genomic information more accessible and useful. By making Broad's GATK available through the Google Cloud Platform, we hope to accelerate great science," said Mr David Glazer, director, Google Genomics. In keeping with the Broad's mission to foster openness and innovation, this collaboration will be non-exclusive. Broad and Google will each continue to engage with other community members on genomic projects to empower research worldwide.     ]]> https://biospectrumindia.com/news/97/6019/fda-nod-for-medtronics-corevalve-evolut-r-system-.html https://biospectrumindia.com/news/97/6019/fda-nod-for-medtronics-corevalve-evolut-r-system-.html Fri, 26 Jun 2015 11:44:44 +0530 Medtronic has announced the US Food and Drug Administration (US FDA) approval and the US launch of the new recapturable, self-expanding CoreValve Evolut R System. It is said to be the first-and-only recapturable and repositionable device available in the US, the Evolut R System is approved for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients who are at high or extreme risk for surgery. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. Designed to treat patients with aortic stenosis, a condition where the aortic valve narrows thereby limiting blood flow from the aorta to the rest of the body, the CoreValve Evolut R System is built on the proven foundation and procedural success of the CoreValve System, which has been implanted in more than 75,000 patients in 60 countries. The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R Delivery System, which features an InLine Sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch). A smaller profile size provides a greater opportunity to treat an expanded patient population with smaller vessels (down to 5.0 mm), through the preferred transfemoral access route, which may minimize the risk of major vascular complications in some patients. Based on the knowledge gained through the extensive experience with the CoreValve System, the Evolut R is optimized to increase conformability and sealing at the annulus, while maintaining supra-annular valve positioning for improved blood flow and hemodynamic performance. An extended sealing skirt on the 26mm and 29mm valve sizes is intended to further promote valve sealing at the annulus. "The FDA approval of Evolut R marks a significant milestone for Medtronic and TAVR, and ushers in a new era in transcatheter aortic valves with advanced, recapturable capabilities," said Ms Rhonda Robb, vice-president and general manager, Heart Valve Therapies, Medtronic. She added, "This approval is an outcome of our commitment to building a market-leading innovation pipeline in the transcatheter space, and we look forward to supporting heart teams as they look to next-generation technologies that optimize valve performance for a broad range of patients."   The 23 mm, 26 mm and 29 mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System are available for use in the United States. The device is also available in Europe and other countries that recognize the CE (Conformité Européene) mark.   ]]> https://biospectrumindia.com/news/97/5617/naz-haji-takes-over-as-head-of-quintiles-india.html https://biospectrumindia.com/news/97/5617/naz-haji-takes-over-as-head-of-quintiles-india.html Thu, 25 Jun 2015 13:24:00 +0530 Based out of Quintiles' office in Bangalore, Mr Naz Haji will be responsible for providing vision, strategic business and technology direction, and operational capabilities to support the company's growth across india and Asia. Mr Haji currently holds a dual role as the country CEO for India, and SVP and CIO Asia. He joined Quintiles in 2006 as Vice President, Global IT in Research Triangle Park, North Carolina, leading Global Infrastructure and Operations. During this time, he led the consolidation and globalization of the Global Information Technology function instituting key processes, functions and delivery capability resulting in world-class performance, quality and stability. In 2007, he was promoted to Senior Vice President. Bringing more than 25 years of experience in international business systems, technology, process re-engineering and consulting, Mr Naz Haji has been a key leader within multiple industries, including pharmaceutical, manufacturing, utilities, oil and gas, engineering and aerospace. His experience also spans the globe having worked and lived in North America, Asia, Africa, Europe and the Middle East. Born in Tanzania and raised in Canada, Naz earned his degree in business from York University in Toronto.   ]]> https://biospectrumindia.com/interviews/97/4849/biometrics-are-quite-useful-in-pharma-industry.html https://biospectrumindia.com/interviews/97/4849/biometrics-are-quite-useful-in-pharma-industry.html Thu, 25 Jun 2015 08:54:00 +0530 Q: What is Iris technology? What is its relevance in context of biotech, medical and pharma industry? Iris recognition technology uses random textures that are visible in the eye, using the eye to confirm someone's identity. Unlike voice, fingerprints & facial structure, iris patterns have far more random patterns. IRIS recognition technology holds the highest CAGR due to highest accuracy. A study by Ernst & Young says that the Indian biometric market will grow to $748 million before 2018. Compounded annual growth for biometric market will be somewhere around 27 percent globally and 47 percent for India and that's purely because Indian government has adapted to the biometric modality. The technology is quite useful in an environment where there is continuous use of PPE - Personal Protective Equipment. A PPE would ideally include a mask or a respirator along with a head cap, hazmat suit and gloves. A gloved hand cannot be used on a finger print reader. Similarly, a masked face will not be detected on a face reader. Thus even when an individual is geared in a full PPE, all he needs to do is to scan his iris and get access. Moreover what is important to note here is the fact that even if someone decides to don a PPE and disguise and choose someone else's identity to breach security and get access, it won't work as the iris scanner will only grant access to the actual person and not the counterfeit intruder. Q: What are its benefits vis a vis other biometric solutions available presently? Most of the biometric methods used for security systems are outdated. Voice, fingerprint and facial recognition methods are easy to fake and have very low accuracy rate compared to iris recognition technology. Speaking in terms of the software, accuracy rate of the iris recognition technology is 1:15 lakh, thumb print - 1:10,000, Apple touch pad - 1:50000, which means the chances of error are 1 in 1.5 million.   Now let's look at the current biometric trend. Between finger print and iris technology, the government would prefer the later over the former due to a number of factors. The government had performed a pilot run on finger print technology and the results were dissatisfactory. Since 70 percent of the population in India is labor class and most of them use their fingers to do any form of field or manual work finger print authentication does not really pass the test. More over finger print patterns also tend to change over a period of time. However in comparison, the irises in the eyes remain untouched and hence their patterns remain unchanged throughout life. This area of the eye is non contactable and does not require any special maintenance. So let's say someone who has just finished work has to scan his fingers on a finger print scanner, in such case he will have to touch his bare fingers on the reading pad. Now in an attempt to touch the scanner the person soils the reader, thus making it difficult for next person to scan his finger as the reading pad is already damaged. Now consider iris. Iris readers are non contact and tamper proof and there is no possibility of any foreign material coming in contact with the scanner as the eyes can be scanned from a distance of two meters. Why iris? Because from birth to death the iris patterns in a human eye would remain unchanged. What is interesting is the fact that earlier cost was an issue with this technology, however with the change in times Biomatiques have made this technology available at the cost of finger print technology making it affordable with better security control and identification assurance. Q: How are offerings from your company better than others in competition? Not every player in this segment is able to comprehend the importance of this biometric modality in the way Biomatiques Identification Solutions does. Our technology goes well with "Digital India" programme of GoI. Where internationally there are 12 companies already in the global market, our products were designed after keeping in mind the Indian demography. In India, nearly 70% population belongs to the labour class and the remaining 30 per cent is the office class category. Very few people know about the technology, so to introduce a simple, easy to understand and operate product was the main challenge. Secondly, India is a cost effective nation and the Indian consumer believes in value for money. Thirdly, India has a different topology across. So over every 100 kms, people change, the climatic conditions change, their lifestyle changes, even knowledge and education levels change. Understanding this is very essential. Hence, the way the people will adapt to the product will also change depending on region to region.   In terms of price, Biomatiques offers the technology at a cost effective rate compared to other companies. The actual market price is Rs 9,999/-, however we are offering it at a promotional price of Rs 4,500/-. Other companies on the other hand won't be selling their products for anything less than Rs15,000. Moreover manufacturers from overseas only have their vendors in India who lack knowledge about the product in terms of integration or providing technical support for that matter. While Biomatiques has their own R&D and support team, hence reaching out for integration or technical support is much easier. In short you are getting a product which is three times lesser the price and you also get an end to end solution with local maintenance and support. Q: Which kind of market exists here in India for this technology? The market in India is huge. A household consumer can mount the iris scanner outside his door and have keyless entry or even connect it to his personal computer or android phone and use it as an additional measure of security.It can also be used in offices and schools to capture attendance accurately negating the nuisance of proxy attendance. The technology can also be synced with debit and credit cards. Along with just PIN the card won't work unless iris is verified. Every digital or online payment will be connected to AADHAAR database. The biggest market is the government itself because there are a lot of services offered by the government like EPDS, AEPS and rural employment schemes. Data centers which keep secure data which are at a high risk of security breach, research and science centers where individuals are required to wear gloves and masks and other protective equipment, paint factories where workers have paint on their fingers most of the times are some other places where the technology can be useful. The technology can also be used at border and airport to ensure that only the actual citizens get entry in the country. Q: With such advancement of technology what are growth opportunities as such?   The growth opportunities are tremendous. In India, the AADHAAR will be used as a means of identification every citizen in India. The unique AADHAAR number will be allotted to every individual and thus eradicating the need of KYC documents. Banks, utility centers and even telecom industry will be some of the places where this technology can be implemented. Earlier to get a SIM card or to open a new bank account the process would take ideally anywhere between 48 hours to 2 weeks. Tomorrow, if someone wants any of these, all they have to do is scan their iris on the iris scanner which will be linked to the AADHAAR database. Once verified, it will be simple to issue a new SIM card or a new bank account. Considering the population of India, since this technology is very new, it has a huge market scope across sectors. Q: What is the future of this technology? The pressure on today's C-Level executive's to have secure business systems is ever increasing. With the rapidly changing computing landscape in making passwords and other legacy authentication methods obsolete and why biometrics is gaining traction as the preferred choice of authentication of users and devices for commercial as well as enterprise use-cases.One area where security can be improved is in strong authentication of human & devices, which is interacting with the various high-end security technologies where biometrics authentication find greater applicability today includes Enterprise Mobility Management (EMM) suites, Identity and Access Management (IAM) and Internet of Things. This need comes from security-conscious consumers, employees, and more importantly, institutions such as banks, finance & insurance (BFSI), retailers, and other tradespersons and employers, who are uptight to prevent financial frauds and vulnerabilities, privacy abuses, and theft of corporate / users' personal information, which can be addressed through use of biometrics authentications solutions having security portfolio and products that helps in controlling access to enterprise resources with greater accuracy, efficiency and user-convenience in a distributed environment displacing traditional detection tools. The increasing significance of digital identity has taken the process of authentication to a level where the concerns for strong identification can best be addressed only through the use of biometrics. Although the opportunity for revenue associated with deployment of every biometric modality is becoming evident, the one which looks most promising is the Iris Recognition Technology.   The factors which are catapulting this technology to the forefront of biometrics applications are its ease of use and being independent of environmental conditions. Iris recognition, a biometric, provides one of the most secure methods of authentication and identification thanks to the unique characteristics of the iris.   ]]> https://biospectrumindia.com/news/97/7954/siemens-receives-contract-from-william-osler-health-system-.html https://biospectrumindia.com/news/97/7954/siemens-receives-contract-from-william-osler-health-system-.html Wed, 24 Jun 2015 11:30:49 +0530 William Osler Health System (Osler) has awarded Siemens Canada Healthcare (Siemens Healthcare) a Managed Equipment Service (MES) contract worth approximately $154 million. For a contract life-time of 15 years, Siemens Healthcare will provide Osler's three hospital sites with a comprehensive suite of services that will manage the majority of its medical imaging equipment. The deal is the first MES contract ever awarded to Siemens Healthcare in North America and the largest Siemens Healthcare contract win in Canada to date. The contract includes the procurement, ongoing replacement and maintenance of approximately 190 pieces of diagnostic imaging and diagnostic cardiology equipment in total. Among them are computed tomography scanners, magnetic resonance systems, ultrasound, breast imaging and x-ray equipment, angiography solutions, as well as molecular imaging equipment. Within the scope of the contract, Siemens Healthcare will also offer financing solutions, ongoing education and training for clinical users, onsite technical support, room renovations, professional services and a technology refresh program. "We are delighted that William Osler Health System has chosen Siemens as its partner for the next 15 years. This award demonstrates our commitment to providing customer-centered, sustainable healthcare solutions for our customers in the Canadian market," said Mr Jim Graziadei, senior vice-president, Siemens Healthcare. He added, "Throughout the term of the partnership, we will provide Osler not only with state-of-the-art technologies from all vendors but also with the financial security and technology certainty Canadian hospitals require. This MES partnership will help them proactively manage the pressures of growing healthcare costs and increasing patient expectations of improving clinical outcomes in the long-term." "We are excited to partner with Siemens over the next 15 years and achieve an exciting international and Canadian first with their organization," said Ms Joanne Flewwelling, executive vice-president, Clinical Services and chief nursing executive, William Osler Health System. She added, "One of Osler's key areas of focus is on building partnerships that will have long-term, positive impacts on the community we serve. Our work with Siemens will help position us to be on the leading edge in so many of the services and programs we provide through the sustainable use of innovative medical imaging equipment."         ]]> https://biospectrumindia.com/interviews/97/6837/genomics-market-is-getting-a-major-push.html https://biospectrumindia.com/interviews/97/6837/genomics-market-is-getting-a-major-push.html Wed, 24 Jun 2015 08:23:00 +0530 Q: How has been the performance of Premas Lifescience in the last one year? Which are the factors that contributed to its growth? Last year was another landmark year for us in terms of business growth. Inspite of a major slowdown in research funding and specially capex spending, we could still grow by 61 percent and maintained an annual CAGR of 59 percent over the last 8 years since inception. While the Illumina business continues to draw the highest share of the pot, we are very happy to see a significant increase in our Non Illumina business last year. For our consistent performance, we have received the best distributor award from Illumina for two years in a row now. Key drivers of growth were higher pull through of reagents from our existing customers and adoption of the NGS technology by applied markets, mainly clinical. Increased number of service providers adopting our technologies contributed significant growth to our business. We sold more than 25 new platforms in the last year and are hoping to see an even higher reagent pull through this year. Bagged some large contracts of multi sample genome re-sequencing projects from leading research institutes. One more striking feature of our success last year was that 50 percent of our business came from private accounts. Q: What are the current trends in the Indian genomics and sequencing markets? What are the latest technologies marketed by you in India? Currently, genomics and specially NGS is getting a major push in various applied markets apart from the traditional research space. Sectors such as clinical, food testing, Agbio, pharma, forensic, HLA, reproductive health and public health are gaining traction. While in academic research, resequencing (exome, target reseq) of genomes draws the highest revenue whereas in the clinical and reproductive space, applications such as oncology, cardio, Preimplantation Genetic screening( PGS) for screening aneuploidies in embryos during IVF and NIPT( Non invasive prenatal testing) are seeing the highest surge in Indian market. On one hand NGS based panels are fast catching interest and on the other hand small plex genotyping panels (Fluidigm low to mid plex snp genotyping) which are highly cost effective and offer faster TAT, are getting quite popular too. Another promising area that is building up consensus (quite well established and utilised in western world) right now is single cell genomics. Our current portfolio for genomics mainly includes Illumina's various sequencing platforms (Hiseq, Next Seq and Miseq) and array platforms (Iscan); Fluidigm (Single Cell genomics platform- C1, Polaris, SNP genotyping , Gene Expression and digital pcr platform- EP1 & Biomark HD, Target resquencing library prep platform-Access array; Hamilton's automation; Covaris's technology for shearing of DNA/Chromatin; Epicentre and Biomatrica's room temperature storage of nucleic acids. Q: How big is the market size in India? What are your predictions for the next one year? Difficult to put a figure on the market size as there are no reliable reports or data available. But the thumb figure of NGS and array products put together will be around Rs 150-175 crore. Our crystal ball gazing and interviews with soothsayers in the field predicts a promising next year with respect to growth in the applied markets and service providers business where as academic funding might still remain a challenge. Q: Biosuppliers of late have been talking about the 'Make in India' initiative. Are you planning to enter the field of manufacturing any time soon?   We strongly endorse made in India and make for India and are quite keen to develop some locally relevant genetic panels for both human and non human species. Premas already has a advanced manufacturing facility( 1500 litre fermentation) at Manesar wherein we are manufacturing a lot of recombinant proteins for many Global Life sc, Diagnostic, Pharma and Ag bio players . We have cloned and expressed more than 500 proteins and developed our own CHO cell lines and expression vectors in last 7 years. Based on this we have successfully completed many custom projects for large global players. Q: How did the company perform financially? What was the revenue of FY 2014-15? As stated earlier, we grew by 61 percent year on year (YOY) and sold almost 104 crores worth of products and services as against last year's Rs 66 crore. Q: Where do you see Premas Biotech in the next few years? Both the verticals at Premas Biotech i.e the Premas life sciences business and the contract manufacturing and research services are at showing significant growth and we are planning to continue and expand in newer markets with newer products & services. In next few years apart from consolidating our leadership position in Indian genomics space, we are seriously getting into newer arenas like Cellomics( label free technologies from Acea) and automation( Hamilton) to have a well distributed portfolio. Although we are looking at new frontiers but we will not be compromising our core principle of being only in the differentiated and cutting edge technologies space. In addition to above, PLS upon requests from our partners is also seriously exploring option of extending our brand out of India and replicating the same business model in other regions. We plan to develop and manufacture Dx panels in India which can be both for domestic consumption as well as exported out. We wish to move up the value chain and offer analysis and analytics solutions to the global life sciences and MDx market. ]]> https://biospectrumindia.com/news/97/6649/medtronic-acquires-aptus-endosystems.html https://biospectrumindia.com/news/97/6649/medtronic-acquires-aptus-endosystems.html Tue, 23 Jun 2015 11:05:16 +0530 Medtronic has announced that it has acquired the assets of Aptus Endosystems, a privately held medical device company focused on developing advanced technology for endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Additional terms of the acquisition were not disclosed. Aptus Endosystems' Heli-FX and Heli-FX Thoracic EndoAnchor systems feature an endovascular deployed anchor designed to attach a variety of aortic endografts to the native vessel wall. This off-the-shelf, customized solution minimizes the need for complicated procedures for the select subset of patients who would benefit from supplementary fixation. This may include patients with challenging anatomies, risk factors for a secondary intervention, existing seal complications, as well as in situations where a physician may intraoperatively determine the need for additional security. "We are excited to add this unique complementary, anchor technology to our aortic portfolio. The Heli-FX and Heli-FX Thoracic EndoAnchor systems strongly align with our strategy to invest in treatments that address complex aortic disease with a vision to treat disease of the entire aorta," said Mr Daveen Chopra, vice-president and general manager of the Aortic business, within the Cardiac and Vascular Group at Medtronic. The Heli-FX and Heli-FX Thoracic EndoAnchor systems bear the CE Mark for distribution in the European Union and are cleared by the FDA for distribution in the US. The Heli-FX and Heli-FX Thoracic EndoAnchor systems can be used with a wide variety of commercially available stent grafts, including Medtronic's Endurant and Valiant stent graft systems. As part of the acquisition, Medtronic will also distribute the TourGuide(TM) Steerable Sheath, a device with adjustable tip that enables quick access and delivery of peripheral vascular products to the most challenging anatomy, in the US and Europe. "Medtronic's acquisition of the Aptus technology is validation of our mission to bring a durable solution to patients with challenging anatomies," said Mr James Reinstein, president and CEO of Aptus Endosystems. He added, "Having the Heli-FX available in the broad distribution channels of the market leader, will be very good for our EVAR physicians and their patients."   The company will report the Aptus business as part of its Aortic and Peripheral Vascular division within the Cardiac and Vascular Group.     ]]> https://biospectrumindia.com/interviews/97/7859/we-are-fully-committed-to-grow-our-presence-in-india-and-asia-pacific.html https://biospectrumindia.com/interviews/97/7859/we-are-fully-committed-to-grow-our-presence-in-india-and-asia-pacific.html Tue, 23 Jun 2015 08:41:00 +0530 Cole-Parmer is now a standalone entity and offers a portfolio of industry-leading products in the laboratory market and its Asia-Pacific MD, Mr Aggarwal, in an exclusive interview with BioSpectrum, discusses the company's market dynamics in the region, especially India. Please share with us a bit on the recent changes and their impact on the Cole-Parmer market positioning and revenue potential?Cole-Parmer is now an independent company. This provides a tremendous opportunity to expand the existing strong business through newly directed focus and energy. The company's continued focus remains on strengthening the product portfolio and market channels that will help us service and access our various customer segments more effectively and competitively. With this change, how are your customers in India & APAC region going to benefit?As we have become a "stand-alone" entity once again, it's time to take a leap both in customer experience and record substantial growth not only in India but also in other Asian countries. In order to achieve this in India, we moved to a new corporate office in Mumbai and opened direct offices in Hyderabad, Bangalore, and Delhi. We have also set up a new warehouse in Bhiwandi with state-of-the-art infrastructure. The aim is to provide our customers with improved support and faster responses and this underscores our continued commitment to serve our customers better.Cole-Parmer is growing significantly in India-what is the secret of success in competitive as well as challenging markets?Cole-Parmer has been in India for more than 15 years, with a direct presence in the last eight years. We have a strong presence in the pharma and biopharma markets. Today, a large part of our business comes from biopharma, while the remaining derives from food and processing, chemical, automobiles, and the dyes and pigments industry, besides government-owned research labs.We were among the early entrants in the industry, when we began via a dedicated channel partner in 1996. Then the company was acquired in 2006. We carried forward the strong foundation and further invested in application and after-sales support, which are highly sought after by the Indian customers.We make sure we listen to our customer's needs and deliver the solutions they require. Our customer-centric approach, consistency in delivering quality, and continuous improvement through innovation-combined with the latest, hard-to-find products and value-added services-provide the customer with a safer, more efficient, and more productive work environment. What are your plans with respect to India and entire APAC region?We are looking to continue our expansion in the APAC marketplace and serve customers throughout the region. There are various initiatives we are adopting to propel our growth in APAC in the coming years. We continue to strengthen our commercial presence in these regions.Also, we continue to develop and enhance our product portfolio. Cole-Parmer is known for bringing unique and new products to the market, leading to improved processes and increased productivity. We have introduced many new products recently and will continue to offer the latest technologies to help our customers achieve their goals.We are also establishing partnerships with our key customers and channel partners in India and APAC. These channel partners have a wide reach in the research markets, three-tier cities, and markets we have not yet fully explored. We give our partners complete solutions from Lab-to-Process through our entire width and depth of products and services. Together, we also offer value-added services such as demos at customers' sites, logistics support, and product sampling, to mention a few. We are regularly investing in our channel partners capabilities by giving them extensive training on our products.How is Cole-Parmer gearing up to leverage the emerging opportunities in India and APAC? For biopharma product development, we focus on offering tailor-made solutions to help our customers speed up their product development. We also support them to scale-up from R&D to pilot and finally to bulk manufacturing. We are already in the bioprocess manufacturing space with our Masterflex Peristaltic Pumps and fully validated pharma tubing. We are the trusted choice of our customers for fluid handling solutions. Now, customers partner with us for their critical bioprocess product requirements as well. We offer end-to-end customized solutions for aseptic fluid transfer, including a wide range of single-use products such as bioprocess bags and liners, manifolds, and EZ Top container closures, for example. For other markets, we are working tirelessly to bring our customers, the unique and latest products to help them make their processes more efficient and easier. Customers today look for instruments with smaller footprints and user-friendly interfaces. They want data acquisition, protection, and better analytical tools. Research labs today need to produce results fast. High speed, high quality, and dependable lab equipment provides the best returns in the long run.What have been the recent activities in terms of product launches for you? Any plans for expansion of product lines?Recently Cole-Parmer acquired Environmental Express, a leading developer, manufacturer, and distributor of environmental laboratory equipment and consumables. The acquisition of Environmental Express is a key step towards further strengthening of our portfolio with their strong position in water, wastewater, drinking water and hazardous waste analysis. We are now bringing these products to our customers in India and APAC as well.The Digi-Sense brand, re-introduced last year, is a comprehensive new line of test and measurement products. These new technologies deliver accurate readings while withstanding rigorous use. From environmental testing meters to performance monitoring equipment, many of the Digi-Sense products are precalibrated to save time, cost, and effort. The range of products includes thermometers, infrared devices, humidity meters, anemometers, light meters, manometers, borescopes, and tachometers.We also introduced a new line of laboratory filtration products providing consistent performance and ensuring high quality results-at an economical price. The extensive range features sterile/non-sterile membranes and chromatography and air vent filters to serve the needs of R&D for universities, institutes, and pharmaceuticals, QA and QC labs, and the food and beverage markets. Also, we have expanded our selection of safety offerings. Personal protection equipment available now includes safety glasses, goggles, face shields, gloves, respirators, and much more. Product protection includes clean room wipes and gloves, to name a few.Our next focus is on the food and beverage market, which is expected to be more regulated in the coming years. So, we are investing ahead of the curve to bring some of the latest products in this segment such as shelf life analyzers, protein/nitrogen determination systems, and digestion and distillation systems.What do you think of the current growth of the lab-equipment market? Has there been substantial growth over the years? What's your outlook for this market?We are very excited about opportunities in areas such as pharmaceuticals, industrial, process, food safety and environment. India is one of the leading countries in the world in biotechnology development and manufacturing. We also see that the Indian government is demonstrating more commitment to invest in innovation, science, and technology. We understand there will be significant investments in infrastructure as well as food and testing labs across the country.The market environment is rapidly changing and has become more competitive and challenging. Lab equipment manufacturers and suppliers have to grow faster in order to meet the pressing needs of research and development organizations. The industry is focusing on a consolidated experience for consumers because this is what the customer is looking at today. Unlike basic laboratory equipment, which generally costs hundreds or thousands of dollars, high-end systems often demand far more significant investments. So, with the new promising government in India, better economic conditions, and focus on a consolidated experience for the consumers, the market looks favorable. ]]> https://biospectrumindia.com/news/97/7557/new-technology-to-diagnose-hypertension-in-pregnancy.html https://biospectrumindia.com/news/97/7557/new-technology-to-diagnose-hypertension-in-pregnancy.html Mon, 22 Jun 2015 13:32:20 +0530 The company launched the first-of-its-kind biomarker, PLGF (Placental Growth Factor) to meet the alarming threat of the expecting mothers in recent times. PLGF (Placental Growth Factor) is used for accurate diagnosis and prognosis of 'pre-eclampsia', a major cause of maternal, fetal, neonatal morbidity and mortality. As per the industry findings, it is postulated that the incidence of pre-eclampsia is around 10-12 percent amongst Indian women irrespective of zones, against an incidence of 5-8 percent in developed countries. ]]> https://biospectrumindia.com/news/97/4052/philipswmchealth-ink-pact-to-transform-patient-care.html https://biospectrumindia.com/news/97/4052/philipswmchealth-ink-pact-to-transform-patient-care.html Mon, 22 Jun 2015 12:21:26 +0530 Royal Philips and Westchester Medical Center Health Network (WMCHealth) has announced a multi-year, $500 million partnership to transform and improve healthcare for millions of patients across New York's Hudson Valley. The partnership is based on an enterprise managed services model through which Philips will provide WMCHealth with a comprehensive range of clinical and business consulting services, as well as advanced medical technologies such as imaging systems, patient monitoring, telehealth and clinical informatics solutions. The partnership is part of WMCHealth's transformation to a regional network as the largest provider of integrated health in the Hudson Valley. A 1,500-bed health system headquartered in Valhalla, New York, WMCHealth spans seven hospitals and several campuses and locations, along with nearly 300 healthcare partner organizations. Its flagship, Westchester Medical Center, is the only regional resource for complex medical and surgical interventions, covering 6,000 square miles in eight counties and serving more than three million people. "In order for us to make the large-scale improvements that will truly impact the lives of our patients, we need to think longer term and be able to adapt quickly as technology evolves," said Mr Michael D Israel, president and CEO of WMCHealth. He added, "Our alliance with Philips not only gives us access to the latest in connected digital health technologies, it will allow us to collaborate on pro-active health management and co-create new patient-centered models of care for the Hudson Valley area. Together, we are working to keep the Hudson Valley healthy through a model that supports innovation and transformation in a value-driven environment." The partnership underscores Philips' commitment to provide new solutions for hospitals and health systems driven by a fundamental shift in the US healthcare management towards strategic partnerships for creating long-term patient value, while managing costs, complexity and risk. In similar long-term partnerships with Philips, hospitals have been able to significantly improve radiology volumes and cut MRI waiting times in half. These organizations are seeing a 35 percent reduction in technology spending, while improving clinical quality. "With health systems facing increased pressure and more complex challenges than ever before, and patients starting to take a more active role in their care, we can no longer accept the status quo," said Mr Frans van Houten, CEO of Royal Philips. He added, "Health systems need a dedicated partner that can bring not just technology, but also deep healthcare and consumer expertise, resources and solutions that will help accelerate the transformation of their organization and ecosystem. Our partnership with WMCHealth reinforces our leadership in long-term, strategic collaborations, allowing health systems to expand access to quality care, manage costs and share risk. This allows them to focus on what matters most: delivering better care to the people in their communities."   A joint onsite WMCHealth - Philips team will work to optimize medical technology deployment and IT integration into a unified platform that will enhance WMCHealth's already impressive operational excellence. With an early and ongoing access to the latest Philips innovations in health technology, WMCHealth will be able to maximize the effectiveness of its participation in New York's Delivery System Reform Incentive Payment (DSRIP) program, aimed at restructuring the healthcare delivery system by reinvesting in the Medicaid program, with the primary goal of reducing avoidable hospital use by 25 percent over five years.   ]]> https://biospectrumindia.com/features/97/6840/global-home-healthcare-market-revenue-to-grow-to-355-bn-by-2020.html https://biospectrumindia.com/features/97/6840/global-home-healthcare-market-revenue-to-grow-to-355-bn-by-2020.html Fri, 19 Jun 2015 15:27:30 +0530 The global market for home healthcare is expected to reach $355.3 billion by 2020, growing at an estimated CAGR of 7.8% from 2014 to 2020, according to a new study by Grand View Research. Home healthcare products are generally applied to a broad range of equipment and services designed for exclusive use for home or other non-medical establishments by non-professional caregivers, family members, or the patients themselves.  Home healthcare is rapidly getting adopted as a cost effective alternative to healthcare establishment based therapy and therefore, growing geriatric population base and prevalence of chronic conditions requiring long term care is also expected to have a positive impact on growth. Presence of untapped potential in emerging markets such as India, Brazil and China and increasing health awareness are expected to serve this market as future growth opportunities. ]]> https://biospectrumindia.com/news/97/7641/fortis-launches-new-app.html https://biospectrumindia.com/news/97/7641/fortis-launches-new-app.html Fri, 19 Jun 2015 15:16:29 +0530 Fortis Healthcare launched its new app Fortis 4U, which enables patients to book appointments across Fortis Hospitals in Bangalore. The app will also enable patients to offer their feedbacks to Fortis. According to the company, the downloadable app is available on both Android and Apple for free. ]]> https://biospectrumindia.com/news/97/4029/teletracking-and-ge-healthcare-collaborate.html https://biospectrumindia.com/news/97/4029/teletracking-and-ge-healthcare-collaborate.html Fri, 19 Jun 2015 14:10:53 +0530 GE Healthcare and TeleTracking Technologies announce a new collaboration agreement. The collaboration enables GE to place greater focus on its asset and workforce optimization solutions while leveraging TeleTracking's patient flow solutions and integrated operational platform. The two companies will work together to transition all interested clients currently on GE patient flow solutions to suitable TeleTracking solutions. Additionally, GE and TeleTracking will look to drive improved operational outcomes while reducing the cost burden placed on providers. Over time, the two companies will help health systems drive further operational efficiencies through shared data and analytics. Larger data sets from multiple technology sources including, among others, asset management, hand hygiene compliance monitoring, bed and patient tracking, and staff scheduling will provide hospital leaders with more detailed insights to improve daily operations and patient access. The collaboration also leverages both companies' strengths in real-time location enablement. "TeleTracking and GE Healthcare have long led the development of technologies that improve hospital operations. This alliance supports our strong commitment to integration with all like-minded healthcare IT leaders, for the betterment of patient care," said Mr Michael Gallup, president, TeleTracking. "We look forward to advancing the shared aim of both companies to improve healthcare delivery by improving hospital operations and reducing unsustainable wasteful spending in our industry," said Mr Joe Shrawder, CEO, GE Healthcare Global Services.   ]]> https://biospectrumindia.com/news/97/7564/icon-launches-firecrest-patient-portal-.html https://biospectrumindia.com/news/97/7564/icon-launches-firecrest-patient-portal-.html Thu, 18 Jun 2015 12:29:17 +0530 ICON has announced the launch of the Firecrest Patient Portal. This portal enables patients to view clinical trial information and is specifically designed to enhance the patients understanding of treatment before consenting to participate at an investigator site. The Patient Portal solution is a component of ICON's new informatics hub designed to enhance the engagement of patient populations in the development process and is line with ICH E6 guidance, which recommends patients receive 'ample time' to review consent materials and ask follow-up questions. "The opportunity for education about the trial, before a face-to-face meeting with their doctor, helps patients make truly informed decisions about participation," said Ms Frances Abeton, vice-president, Firecrest at ICON. She added, "Improved patient comprehension of a trial can reflect positively in patients' relationships with investigators and subsequently lead to better recruitment and retention rates. As drug developers begin adopting electronic informed consent platforms improved regulatory-compliant education will be crucial. The Firecrest Patient Portal is a centralised solution for patients, investigators and study staff, making it easier for all involved to interact and stay informed." Patients using the Firecrest Patient Portal can find active trials, complete pre-screening questionnaires and select a convenient study location. As the Patient Portal is integrated with ICON's Firecrest Investigator Portal, investigators can engage directly with patients that have shown interest, schedule visits, and examine live analytics about the materials reviewed by a patient. Patients can read visit-by-visit guides and as the trial progresses, patients can return to the portal to review updates or notifications specific to them. They will also be able to register interest in future clinical trials that will support patient access for upcoming trials. The Firecrest Patient Portal can be customised in any language, adapted to country specific requirements, and branded as required by sponsors.   ]]> https://biospectrumindia.com/news/97/7289/global-glucose-monitoring-system-market-will-be-worth-27-6-billion-in-2020.html https://biospectrumindia.com/news/97/7289/global-glucose-monitoring-system-market-will-be-worth-27-6-billion-in-2020.html Thu, 18 Jun 2015 12:28:26 +0530 The global continuous glucose monitoring system market is expected to reach $27.6 billion in 2020, says a new Research and Markets report. Continuous glucose monitoring System (CGMS) are medical devices which enable the diabetic patients to track their glucose levels. Sensor, transmitter and receiver are the main components of CGMS devices which are available in the price range of $1000 to $1500. According to the report, CGMS market is gradually increasing due to increase in diabetes patients and pouring investment in research and development. Globally, the major market for CGMS devices is North America which is responsible for 80 percent of the contribution in total revenues. The CGMS market has been facing tough competition from Self monitoring of blood glucose (SMBG) device market. North America will continue to be the huge market for CGMS and SMBG devices. However, 80 percent of the total diabetic patients are from emerging economies such as India and China. These are untapped market and the healthcare companies must explore this market for increasing revenues and profit, the report stated.   ]]> https://biospectrumindia.com/news/97/7672/hamilton-robotics-appoints-premas-lifesciences-as-its-distributor.html https://biospectrumindia.com/news/97/7672/hamilton-robotics-appoints-premas-lifesciences-as-its-distributor.html Wed, 17 Jun 2015 14:53:39 +0530 Hamilton Robotics has announced a new partnership in India together with Premas Lifescience, a fast growing distribution company based in New Delhi, India.  Hamilton Robotics is a pioneer in liquid handling equipment and laboratory automation technology. It is known for advancing life science and biotechnology industries through reliability, performance and flexibility. Hamilton is the industry leader in design and manufacturing with patented technologies such as Compression-induced O-Ring Expansion (CO-RE), Total Aspiration and Dispensing Monitoring (TADM) and Anti-Droplet Control (ADC). "We are excited to welcome Premas Lifesciences," says Mr Davide Tonetto, business manager-emerging countries, Hamilton,"We believe the skills and the experience of Premas make them the right partner to access and service the Indian market with our products and our technologies." As per Mr Praveen Gupta, founder and executive director of Premas Life sciences, "We think it's a great addition to our portfolio of cutting edge life sciences solutions for the Indian market.Hamilton is world leaders in automation and we are sure that it will meet the complex and growing needs of the discerning Indian researchers." "Since our inception, we are dedicated to provide quality services to the biotech industry. Our focus has been not only to deliver but serve with care. We want to add value to the system besides contributing to India's growth and reputation," he told BioSpectrum over phone.  Premas will be distributing Hamilton products not only in India but Nepal, Bangladesh and Sri Lanka as well.   Recently at Illumina's distributor event at Phuket, Premas has been rated as Illumina best distributor of the region. This has put Premas in the ELITE category of partners that Illumina has worldwide and will give even higher visibility to Indian needs. This is the second year in the row that Premas have been awarded this coveted honour. In the last 9 years Premas Lifescience has made major inroads in the Indian genomics and Mol Dx market offering some of the most cutting edge technologies from brands like Illumina, Fluidigm and many more.  Premas was founded in 2005 by a group of Techno commercial professionals who had diverse skills and a history of success across sectors like Energy, Biotech and FMCG markets . The organization has two major divisions - Contract Research and Manufacturing (CRAMS) and Life Science Solutions. The Life Science division was incepted for launching a bouquet of cutting edge solutions for the Indian Research and Applied markets.   ]]> https://biospectrumindia.com/news/97/8439/genotypic-tech-msruas-seal-deal-to-research-oral-cancer-at-genomics-level.html https://biospectrumindia.com/news/97/8439/genotypic-tech-msruas-seal-deal-to-research-oral-cancer-at-genomics-level.html Tue, 16 Jun 2015 09:54:31 +0530 The MoU has been signed for 4 years. MSRUAS will be paying Rs 50 lakh to Genotypic Technology under the terms of the deal. The prevalence of oral cancer is said to be common in India. "The age-adjusted rates of oral cancer vary from over 20 per 100,000 populations in India, to 10 per 100,000 in the United States, and less than 2 per 100,000 in the Middle East. In comparison with the US population, where oral cavity cancer represents only about 3 percent of malignancies, it accounts for over 30 percent of all cancers in India," opined Dr Roopa Rao, professor & HOD, department of oral pathology, faculty of dental sciences, MSRUAS. In the current scenario, biomarkers or PCR techniques are extremely important in cancer research which help identify the target organism and vaccine preparation. "Genomics is not a science. It is a tool with immense power and potential, and is being applied in every area today. This collaboration is mainly going to bring in exposure on genomics knowledge to clinicians and its practical applications for patients, since genomics is usually used more for research purposes than for treatments," said Dr Raja Mugasimangalam, president, founder & CEO, Genotypic Technology. All the current intellectual properties (IPs) owned by Genotypic and MSRUAS will be owned by the respective parties.   However, any IPs arising during the R&D collaboration process will be discussed and sorted out later between the two collaborators. According to Genotypic, through this pact, for the first time in India, it is 'hoping' to bring in Illumina's HiSeq X10, which is said to be the most powerful DNA sequencer in the world. The HiSeq X10 has the capability to sequence 1 lakh people a year, each machine costing about $10 million. So far, Korea has 2, Qatar-1 and the US has 5-6 of the X10 machines. Genotypic has also signed other collaborations with All India Institute of Medical Sciences (AIIMS) New Delhi, Christian Medical College (CMC) Vellore, and Manipal University.   In June 2015, the company sequenced the genome of Indian herb Tulsi, in collaboration with Central Institute of Medicinal and Aromatic Plants (CIMAP), Lucknow. Dr Raja added, "This was world's first large genome to be sequenced and assembled in India, purely of Indian work without any external collaborations outside the country. We have also sequenced bitter gourd, a very good anti-diabetic, in association with Indian Institute of Vegetable Research (IIVR)." In the future, the company intends to sequence disease causing bacteria like TB and Indian malarial parasites. "We are also planning to sequence useful insects like bees in India, which has already been done in the Middle East," Dr Raja revealed. Genotypic's business, in the last year, grew by 20 percent with reduction in its profitability mainly due to the Rupee devaluation, and incurring heavy cost investments in infrastructure and machineries. The company in December 2013 spun-off India's first agri-genomics start-up company, QTLomics, and in the following year, Dhiti Omics, another start-up, a provider of molecular diagnostic services. ]]> https://biospectrumindia.com/news/97/6559/intel-ge-care-innovations-to-test-telehealth-with-senior-citizens.html https://biospectrumindia.com/news/97/6559/intel-ge-care-innovations-to-test-telehealth-with-senior-citizens.html Mon, 15 Jun 2015 12:48:07 +0530 Intel-GE Care Innovations, a joint venture between Intel Corporation and GE Healthcare, has announced a partnership with the Front Porch communities and the Front Porch Center for Innovation and Wellbeing to measure the benefits of leveraging remote patient monitoring (RPM) with senior living residents. Residents of Kingsley Manor in Los Angeles and Claremont Manor in Claremont, California, will use Health Harmony, Care Innovations' RPM platform that simplifies RPM by providing intuitive and easy-to-use technology that enables individuals, clinicians, care providers, and family caregivers to collaborate for better care in the home, wherever it may be and within normal daily routines. Initially, Health Harmony will be available to a group of Front Porch residents who may require a higher level of care and monitoring due to poor chronic condition management or following a return to a senior living community after a discharge from a skilled nursing facility. "Health Harmony gives Front Porch a way to extend the care continuum directly to their residents while also supporting the independence they strive to deliver every day," said Mr Sean Slovenski, CEO of Care Innovations. He added, "As the aging population continues to grow, it's important that senior living communities are part of efforts to help people live healthier lives at a more sustainable cost. Front Porch is a forward-looking organization taking a fresh look at how technology can help them with resident well-being, which we know is one of their major priorities." Residents of Kingsley Manor and Claremont Manor who use Health Harmony will conduct daily health sessions to capture vital signs such as blood pressure, weight, oxygen levels, and glucose levels, subjective health assessments, and other information needed for caregivers to manage care plans, promote medication adherence, and remain on top of patients' changing health. Residents also have access to a video chat platform through Health Harmony that enables a caregiver and the resident to virtually connect with one another to discuss conditions and assess a resident's environment. "Front Porch and Care Innovations share a common vision of technology-enabled care to help the aging population live well and remain healthy wherever they call home. Our partnership with Care Innovations opens opportunities for our communities to become more deeply involved in helping residents manage their health with new models of care in a way that meets their specific needs," said Ms Kari Olson, president of the Front Porch Center for Innovation and Wellbeing.   ]]> https://biospectrumindia.com/features/97/6072/stringent-fda-requirements-pose-major-challenges.html https://biospectrumindia.com/features/97/6072/stringent-fda-requirements-pose-major-challenges.html Sun, 14 Jun 2015 08:14:00 +0530 Ingersoll Rand brings expertise to pharma and healthcare industry with sustainable solutions in the areas of HVAC and compressed air systems, tools, security technologies, and mobile or static refrigeration. The HVAC for pharma market is growing at a CAGR of 8 percent, while the pharma HVAC market was around $10 million for chillers and AHU (air handling unit) in 2014. "The government has already unveiled 'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug manufacturing, thereby making this sector highly lucrative for investments and growth," said Mr Sudarshan Ananth, territory VP & business head, HVAC & transport, India Climate Business Unit, Ingersoll Rand. Emerging trends India being the 3rd largest producer of pharma products and responsible for 8 percent of the world's production is a strategic market for HVAC products.   Indian pharmaceutical manufacturing facilities registered with US Food and Drug Administration (FDA) as on March 2014 was the highest at 523 for any country outside the US. "There is a continuous capacity expansion needed to achieve high growth rates. We have seen a surge in the demand for AHU and chillers, with the pharma market now dominated by water-cooled and air-cooled screw chillers, with the former having a higher leverage due to better efficiency," Mr Ananth commented. The Indian pharma industry is growing at a faster rate owing to large demand both in terms of import and export. Pharma Industry is expected to touch $55 billion by 2020 from the $12 billion levels in 2013, and with 60-70% of revenues coming from the exports. "Therefore, usually the last mile connectivity is a problem in pharma industry, as there is a need for refrigerated or conditioned transport for the drugs to the clinics or warehouses. It is imperative that organizations invest on technologies that are environment-friendly and sustainable, so as to address these issues more accurately and make distribution more efficient," Mr Ananth pointed. India and international markets According to Ingersoll, all major drug manufacturers in India use its chillers. "We have a strong presence in all the drug manufacturing states including Telangana, Himachal Pradesh and Maharashtra," he opined. For Ingersoll, India is a key attractive market. "Other markets like Taiwan, Vietnam, Indonesia and Thailand are a growing market for us. We have a strong presence in all these markets. Our strategy of offering products that meets the local needs have helped us to grow well in these markets also," observed Mr Ananth. Hottest hurdles He pointed that there are a variety of healthcare challenges that are a barrier to better healthcare service and pharma solutions in India. "The key challenge faced by the industry today is meeting the stringent FDA requirements on providing the proper environment which need controlled humidity," he revealed. He further technically explained, "Many times, dehumidification is a costly process, and hence efficient heat recovery from the chillers are a big challenge. Controlling the complete system in an integral way from clean room door opening to chilled water management using single controls is a big challenge." Biggest opportunities Healthcare for all is a focus area for both central and state governments in India and other developed nations like the US. The HVAC industry has direct bearing on the growth of pharma and hospital sector. "Hence, with the pharma sector poised to grow, especially with the state government providing appropriate infrastructure for growth, we feel there is a huge opportunity for HVAC players to look at newer playing fields," Mr Ananth emphasized. Controlled air environment is necessary for temperature-controlled transportation of pharma products from source or manufacturing facility to storage or distribution centres, or within the manufacturing facility. He also added that the localization push will necessitate a capacity expansion in the industry and in turn will help growing usage of HVAC. "Identification of new export markets and opportunities for Indian companies in China will also lead to capacity expansion in the industry," expressed Mr Ananth. Energy efficiency seems to be a key cost driver in the pharma and healthcare industry. Thus, HVAC companies are now offering a variety of HVAC technology solutions to increase energy efficiency. Further expansion "We are expanding our business by offering VRF (Variable Refrigerant Flow) products in the hospitality, healthcare and commercial real estate segments, and launching energy efficient residential air conditioners with green refrigerants like R410a," Mr Ananth noted. The company believes that its new wireless controller product is going to be a game-changer in the industry with hassle-free, reliable installations, and best-in-class technologies. ]]> https://biospectrumindia.com/news/97/6180/a-new-smartphone-device-to-detect-skin-cancer-early.html https://biospectrumindia.com/news/97/6180/a-new-smartphone-device-to-detect-skin-cancer-early.html Fri, 12 Jun 2015 12:30:56 +0530 Simon Fraser University PhD alumna Ms Maryam Sadeghi has developed MoleScope, an innovative hand-held tool that uses a smartphone to monitor skin for signs of cancer. Ms Sadeghi, who laid the groundwork for the device during her PhD thesis research, has spent three years transitioning from academic research to her start-up venture, MetaOptima Technology. The company's inaugural product is MoleScope, a device that enables people to monitor their moles and skin health, share images with family and healthcare providers and eventually, connect with skin specialists online. "I love working with people to help them manage their health. This is exactly what I imagined doing as a student and now my vision is being realized through the launch of MoleScope, and my company, MetaOptima Technology," said Ms Sadeghi. MoleScope comprises a mini-microscope that attaches to a smartphone, an app (iOS, Android, or web compatible) and a cloud-based analytical platform called DermEngine. Once people take high-quality, high-resolution images of suspicious moles or skin abnormalities, they can archive images and communicate concerns with others.   Visual changes in skin often signal the possibility of skin cancer. It is estimated that 70 percent of skin cancer is caught by individuals and family members. The company has developed two versions of the product: a consumer version expected to retail at $149; and a more expensive professional version to be presented at the World Congress of Dermatology meeting. MoleScope has received approval from Health Canada, and is FDA-registered as a Class I medical device in the USA, CE mark in the EU and TGA approval in Australia is expected shortly. The company is also initiating an early adopter program with qualified dermatologists. Ms Sadeghi won recognition during the research and development phase of MoleScope winning WaveFront's Wireless Prize package ($40,000) in the BCIC-New Ventures Competition in 2013, plus a prize in the Plug & Play Silicon Valley competition in Vancouver in July 2014.   MoleScope is to be unveiled at world dermatology conference in Vancouver, June 9-13.   ]]> https://biospectrumindia.com/news/97/3444/medical-networking-app-curofy-launched.html https://biospectrumindia.com/news/97/3444/medical-networking-app-curofy-launched.html Thu, 11 Jun 2015 12:21:40 +0530 Curofy, a medical networking app that enables safe and secure communication between doctors is all set to woo the Indian market by empanelling with the doctors across the country. Curofy is that platform which entitles doctors can easily connect with other doctors for collaborative learning and holistic patient treatment . The agenda behind this venture is to build a medical network for the purpose of collaborative learning and network expansion of Indian doctors mushroom and enhance the Medical across India. Curofy with its online medical directory prepopulates profiles of doctors based on the public data, they fill their basic details to enter into the premium network post verification. It's a spam-free and secure environment to communicate with each other, provide referrals, share cases, call other doctors without saving numbers and have access to most recent, speciality-wise developments taking place in the fields of medicine, surgery, nutrition and dentistry, and even provide a platform for collaborative learning. Curofy has recently launched its job module which experienced a 20% application rate of medical jobs in its pilot phase. Speaking about the developments in India, Mr Mudit, Co -Founder, Curofy, says "The Indian healthcare industry is growing at a tremendous pace due to its strengthening coverage, services and increasing expenditure by public as well private players. Therefore, a platform like Curofy will help the industry to be closely knitted and be connected with each other. With the help of this application, the doctors in India can interact with the doctors across the globe and also recommend their patents if required. . "In as little as three months of its launch, over 3500 doctors, including super-specialists from premium hospitals like Medanta, Apollo, Max and Saket City and physicians from 70 cities, are using the app and actively using it amongst themselves" says other Co-founder, Nipun Goyal. ]]> https://biospectrumindia.com/news/97/6700/philips-partners-with-uz-leuven-hospital.html https://biospectrumindia.com/news/97/6700/philips-partners-with-uz-leuven-hospital.html Thu, 11 Jun 2015 11:50:09 +0530 Royal Philips and UZ Leuven, has announced a collaboration to digitize and optimize cancer research through digital pathology. The largest university hospital in Belgium will be the first hospital in the country to deploy the Philips IntelliSite Pathology Solution with the aim, through research, to enable faster and more confident diagnosis of cancer and better treatment for patients. UZ Leuven examines more than 100,000 tissue samples from more than 5,000 cancer patients each year to provide physicians with clinical context and the most detailed information about the individual's case as possible. Similar to the rest of the world, the number of pathologists in Belgium has decreased significantly while pathology continues to grow more complex. There is a need for innovations that help make the pathology process quicker and more efficient, and facilitate the easy sharing of information between pathologists to improve the process of getting second opinions. UZ Leuven selected the digital pathology solution, developed by Philips, to fulfill this need. "Digital pathology will significantly change the way we work. With the decreasing number of pathologists and the complex environment in which we function, it is important to work more efficiently," said Prof. Thomas Tousseyn, pathologist at UZ Leuven. He added, "A digital network among fellow pathologists in different hospitals can accelerate the process of second opinions in the diagnosis of rare tumors and improve the quality of diagnosis. Next to this, a digital network allows backup agreements and pathology images can be easily shared during multidisciplinary oncology consultation. Also, it offers the opportunity to create a digital learning platform to train assistants and organizing post-graduate training courses."  The new solution consists of a high-speed scanner and image management system to view and interpret images. By scanning the tissue slides, the pathologist will have direct access to the digital files, and cases can be better distributed among the available pathologists. Smart software can assist the pathologist in examining the tissue. In addition, knowledge and images are easily shared in real-time between hospitals and research institutes around the world, thereby creating a virtual network. This will enable international cooperation between experts and open up opportunities in big data research to gain a better understanding of the causes and mechanisms of cancer. "Pathologists play a crucial role in the increasing demand for cancer diagnosis and care. Digital pathology is a promising technology that could contribute to the speed and efficiency of the diagnostic process. Our collaboration with the UZ Leuven, the largest pathology center in Belgium, is an important next step in the exploration of this promising new market for the digitization of pathology," said Mr Cees Smit, director of sales at Philips Digital Pathology Solutions Benelux. Philips recently announced a collaboration in the field of digital pathology with another renowned hospital, Mt. Sinai Health System in New York, to build a large digital image repository of cancer tissue samples for research and big data analysis. ]]> https://biospectrumindia.com/news/97/6305/online-consultation-launched-for-cancer-patients.html https://biospectrumindia.com/news/97/6305/online-consultation-launched-for-cancer-patients.html Wed, 10 Jun 2015 14:28:49 +0530 Cancer patients from Karnataka and anywhere else in India can now receive treatment recommendations from expert oncologists at TMC in less than a week through the online interface of the Navya Expert System. Navya Network, a clinical informatics and patient services company, has pioneered an expert decision system for cancer patients. The Navya Expert System empowers patients with evidence and experience-based treatment options in collaboration with experts at TMC. TMC Online offers online consultations for all types of cancers, including lung, oral, gynecologic, colon, blood, and pediatric. ]]> https://biospectrumindia.com/news/97/6405/dop-issues-national-medical-device-policy-2015.html https://biospectrumindia.com/news/97/6405/dop-issues-national-medical-device-policy-2015.html Wed, 10 Jun 2015 13:13:35 +0530 The Department of Pharmaceuticals (DoP) has issued the draft National Medical Device Policy-2015, for strengthening the 'Make in India' drive in medical device sector, by reducing the dependence on imports and setting up a strong base for medical devices especially those having critical implications in terms of affordability and availability for patients. According to the new draft, an autonomous body 'National Medical Device Authority (NMDA) is to be created under DoP. The Authority shall provide a single window mechanism to the industry with an objective of promotion of the industry to make the country not only self-reliant but also a global hub of production and innovation in medical devices. It will be responsible for setting up and managing, through appropriate corporate body/SPV, Medical Device Mega Parks of various specialization in the vicinity of center of excellence. The government on the recommendations of NMDA, subject to availability of Budgetary resources may provide incentives like preference in govt. procurement for indigenously manufactured devices, low cost funding like interest subsidy to MSME, concessional power tariff for upto 5-10 years, provide seed capital, viability gap funding and co-fund start-up projects, incentivize and promote exports in the sector etc for both Greenfield and Brownfield units. Medical device testing centers to be set up preferably in the PPP mode. Also, the medical devices may be included as a separate entry in the list of commodities controlled under the Essential Commodities Act.   ]]> https://biospectrumindia.com/news/97/5613/golden-helix-collaborates-with-indias-medgenome.html https://biospectrumindia.com/news/97/5613/golden-helix-collaborates-with-indias-medgenome.html Tue, 09 Jun 2015 13:42:24 +0530 The integration will provide VarSeq users with the option to access over 2 million annotated cancer variants. OncoMD is a comprehensive knowledge base of cancer-specific genetic alterations captured from peer-reviewed scientific publications by a team of biomedical curators. After filtering variants of interest using VarSeq, customers can quickly prioritize actionable variants using OncoMD and make clinical decisions based on sensitivity of variants to approved drugs and enrollment to open clinical trials. "This is an exciting partnership with Golden Helix to be able to deliver a robust medical informatics solution that enables precision medicine in the global clinical market," said Mr Sam Santhosh, CEO, MedGenome. "Providing VarSeq users with access to OncoMD, allows clinicians to better tailor diagnostic and therapeutic strategies to individual patients", said Mr Andreas Scherer, president & CEO, Golden Helix. "Having key insights to cancer hotspots and known drug sensitivities, essentially moves precision medicine forward."   VarSeq software streamlines the process of annotating and filtering variants obtained from NGS pipelines, allowing both research scientists and clinicians to find variants of interest in a very efficient and straightforward manner. VarSeq simplifies the user interface and provides a scalable architecture featuring repeatable workflows, note taking, reporting, and filter parameter prototyping. ]]> https://biospectrumindia.com/interviews/97/5479/apex-eyes-acquisitions-in-india.html https://biospectrumindia.com/interviews/97/5479/apex-eyes-acquisitions-in-india.html Tue, 09 Jun 2015 13:03:28 +0530 Estimated at $75 million, the company is a major player in the respiratory therapy and pressure area care sectors. Apex Medical India is a wholly owned subsidiary of Apex Medical Corp. The entry also marked the launch of its three main product verticals in India, including respiratory, support surface and autoclaves. "Apex Medical Corp has entered into India with an open mind and for long haul. We will not hold our decisions that restrict the growth for long term. For this, we are open to being part of 'Make in India' campaign in the next phase of our growth, for example, which could be by setting up an assembly plant or even will consider options to grow by acquisitions," said Mr Daniel Lee, CEO, Apex Medical Corp, while speaking exclusively to BioSpectrum. The company in a statement said that it has long term growth plans in the Indian market and expects to grow at a CAGR of 30 percent. Talking about capturing the market share in India, Mr Lee opined, "This is just the entry phase. We aim to gradually grow the business strategically, and hope to achieve a reasonably good market share in India in the next 5 years."   The company views India as a land full of opportunities. "With the current business trends supported by the present stable, growth-oriented government, we are very positive towards this market right from get-go," Mr Lee pointed. Apex also intends to manufacture its products in India at a later stage. Apex has its business in US, Europe, China and India seems to be its next focus target. When asked about its plans to enter other international markets, Mr Lee said that the plans are 'currently being reviewed'. According to the company, compared to other markets, India is looked upon as a unique market and price sensitive. "It definitely brings with it few challenges. For this we have hired the best talents who are the local experts, and experienced enough to deal with such challenges," Mr Lee optimistically commented. Now that the company has made its way into India, it is actively seeking channel partners in the country. "These partners need to be experts in their local areas across India," it said. Mr Lee noted that the company invests 5 percent of its annual revenues into its R&D. "Normally, our revenue growth pattern is able to justify the growth in R&D expenditure by keeping the percentage the same," he remarked. Apex is now bringing into India, products that have achieved economies of scale and have technological excellence. "We are confident to make the products affordable to Indian customers," Mr Lee observed. Speaking about the company's competition strategy in India, Mr Lee concluded by saying, "We do not believe that healthcare industry is saturated in India. In actual fact, it is continuously growing and there is so much to offer to this market. Our products will not only improve patients' well-being, but will also enhance the quality of life. We aim to provide better environment for every patient striving for excellence in healthcare." ]]> https://biospectrumindia.com/news/97/6390/medtronic-inks-diabetes-pact-with-samsung-.html https://biospectrumindia.com/news/97/6390/medtronic-inks-diabetes-pact-with-samsung-.html Mon, 08 Jun 2015 12:09:30 +0530 Medtronic and Samsung Electronics has announced a partnership to improve diabetes management for the millions of people at risk and currently living with the disease. Both the companies are combining their respective strengths to develop a range of future solutions that will enhance the way people with diabetes live their lives, from remotely viewing diabetes data to ultimately integrating mobile and wearable devices into diabetes management systems. The partnership, announced at the American Diabetes Association 75th Scientific Sessions. It will combine Samsung's deep understanding of consumer mobile technology to deliver secure and convenient access to Medtronic's integrated diabetes management systems that provide clinically-proven outcomes. "By addressing more of the social and emotional aspects of living with diabetes and improving lifestyle fit, we believe that more people worldwide will be able to experience better diabetes control that today's advanced therapies provide. Medtronic aims to transform diabetes by providing world-class integrated care, enabled by leading technologies, big data, and informatics. Our partnership with Samsung is a key step in providing convenient and discreet access to diabetes data, so together we can provide people with diabetes greater freedom and better health," said Mr Alejandro Galindo, vice-president and general manager of the Intensive Insulin Management business at Medtronic. "Samsung is committed to applying its deep understanding of how people use technology to bring new innovations to healthcare. Patients are seeking better ways not only to monitor their condition, but also to enjoy a greater quality of life. We are excited to partner with Medtronic to develop diabetes management solutions that produce positive change and greater autonomy for people living with diabetes," said Dr David Rhew, chief medical officer and head of Healthcare and Fitness for Samsung Electronics America. The partnership's first project focuses on delivering more discreet and convenient access to personal diabetes data by developing mobile applications optimized for Samsung mobile devices that will enable the viewing of insulin pump and continuous glucose monitoring (CGM) information. This application will work with Medtronic's MiniMed Connect product, which provides easy access to important diabetes information for people with diabetes as well as remote alerts for their loved ones, and is expected to be available in the United States later this year. In addition, MiniMed Connect provides healthcare providers with more frequent and convenient access to their patients' insulin pump and CGM via mobile connectivity so they can adjust care plans. Through this partnership, the MiniMed Connect will ultimately be available to more people worldwide, since close to 80 percent of mobile phone users utilize the Android operating system globally.       ]]> https://biospectrumindia.com/news/97/6318/ge-healthcare-upgrades-its-mri-system.html https://biospectrumindia.com/news/97/6318/ge-healthcare-upgrades-its-mri-system.html Mon, 08 Jun 2015 11:22:59 +0530 GE Healthcare has introduced a new in-field upgrade program for 1.5T magnetic resonance imaging (MRI) systems in most regions globally. A currently installed GE Healthcare 1.5T LCC magnet may be upgraded to the new SIGNA Explorer Lift so customers can benefit from the modernized patient comfort, workflow efficiency and diagnostic quality of this system. By upgrading, customers can potentially benefit from cost savings in multiple ways up to 50 percent savings in construction cost, up to 50 percent savings in equipment cost in comparison to a new 1.5T system, and up to 30 percent increase in procedures due to potential increased throughput and referrals. "In a time when healthcare systems are being challenged by reduced reimbursements and longer patient wait times. This upgrade program will enable them to add new clinical capabilities and access the increased efficiency of SIGNA Explorer while leveraging their current MRI investment. By extending their MRI capacity and service lines, clinicians may receive more referrals and therefore potentially generate more revenue. This program reinforces our commitment to the GE Continuum by providing clinicians with solutions to avoid obsolescence and remain up-to-date on the latest clinical offerings," said Mr Eric Stahre, president and CEO of GE Healthcare MRI. The SIGNA Explorer represents the latest offering from GE Healthcare, which is designed to help clinicians improve workflow, lower cost of ownership and improve patient comfort all at the same time. This system was designed to use 34 percent less power than previous generation MRI systems and require a smaller footprint for installation. The upgrade to SIGNA Explorer covers an impressive range of productivity-enhancing applications and new features to enhance patient comfort compared to previous generation systems. For example, SilentScan, GE Healthcare's revolutionary quiet technology, takes patient comfort to a new level. SIGNA Explorer and the upgrade also feature MAVRIC SL, which brings the power of MRI to patients with MRI-conditional metal implants by enabling visualization of soft tissue and bone near the implant. This upgrade will start to be made commercially available to the GE Healthcare MRI installed base during the coming months, in the US and other countries where the SIGNA Explorer is available for sale (and has been approved, cleared or registered by the appropriate regulatory authorities).   ]]> https://biospectrumindia.com/interviews/97/6415/biosimilars-to-jolt-biacore-technology-in-india.html https://biospectrumindia.com/interviews/97/6415/biosimilars-to-jolt-biacore-technology-in-india.html Sun, 07 Jun 2015 08:39:00 +0530 Biacore systems lead the way in analyzing biological interactions, widely studied in the pharmaceuticals and biotechnology space. "Whenever two biological entities interact with each other, researchers involved in drug discovery and drug characterization are concerned to study how the entities interact with each other, how strong or weak the bond is, how much of one entity is needed to bind with the other, and why the entities bind together," explained Mr Lalith Kishore, GM, research products, GE Healthcare Lifesciences. Some of the first successes seen in the world of biosimilars were the results of Biacore. "It is an essential component in establishing biosimilarity," said Mr Kishore. Currently in India, there are 80 active users of Biacore technology. Fifty percent of the users are from the academia and the rest half are in the industry. According to GE, its Biacore business this year touched $3.5 million, and in the next year it expects it to reach $5 million.   This year GE's Biacore has announced the release of the new Biacore software - BIAevaluation Software version 3.0. "Any innovator drug can be compared to a biosimilar for a certain amount of kinetic characterization using the Biacore software. This enables early and late comparability. So most of the biosimilar companies are keenly looking at this technology," revealed Mr Kishore. Significant amount of work has gone in developing the software at GE's R&D center in Bangalore. However, the Biacore instruments are manufactured in Sweden. GE claims that it is the only company offering complete solution cycle including hardware, software and consumables in this area. Mr Kishore pointed out that the spur in the biosimilar market will witness a significant growth for Biacore technology in the country.   Experts say that most innovator drugs are developed in and for the US and UK markets. Thus, much demand is expected from biosimilar companies located in the Asian and other emerging markets. "We have about 50 percent of the market share in India. Globally too, we have significant market share with lesser competition to face," commented Mr Kishore. In India, the first Biacore instrument was sold in 1997 at the Indian Institute of Science (IISc), which GE claims to be still functional. "More than genomics or proteomics, a lot is happening in the biosimilars space today. Interactome is the next big thing happening at the moment," he added. Talking about Biacore instruments pricing, Mr Lalith stated. "There are options not to go for the grandest instruments. There are choices available for companies who are just starting off. A few years ago you needed an investment of Rs 1 crore to start with. Today you can start with a budget of just Rs 50 lakh."   The market for Biacore technology is said to be about $7-8 million, which could double in the next 2-3 years. According to Mr Lalith, the only decelerator to this business are the regulatory woes. "If the regulatory rules get more stringent then it is going to affect this business. The USFDA has already established that SPR (Surface Plasmon Resonance) technology has to be used for establishing comparability. The Indian regulatory scene is still taking shape. However, in the next couple of years, we can expect changes in the regulatory system," he expressed. As for Biacore technology, the major growth drivers will come from both vaccines and novel biologics demand. "We are already working on the next 2 versions of the Biacore instruments. There is competition with other players. We are cognizant of what they are doing," opined Mr Kishore. ]]> https://biospectrumindia.com/news/97/6384/ge-healthcare-to-expand-its-it-center-of-excellence.html https://biospectrumindia.com/news/97/6384/ge-healthcare-to-expand-its-it-center-of-excellence.html Fri, 05 Jun 2015 12:50:20 +0530 GE Healthcare has announced that it is to expand its Healthcare IT Center of Excellence in Szeged, Hungary. At an event attended by the vice-rector of the University of Szeged, Professor Lajos Kemény, and deputy Mayor of Szeged, Mr Sándor Nagy, the company outlined its plans to double the number of software engineers employed at the Centre of Excellence from 20 to 40. The expanded team will help advance the development of innovative software solutions for use in healthcare, including those that support the diagnosis of life-threatening diseases such as liver cancer and other disorders. The engineers at Szeged will also play a key role in the development of Predix, a new software platform developed by GE specifically to connect people, data and machines over the Industrial Internet, which offers the potential to help reduce costs and increase efficiency in healthcare. The further investment in the GE Healthcare IT Center of Excellence in Szeged builds on the company's long-standing and high-level collaboration with the medical and academic teams at the University of Szeged and will also forge links with GE IT development teams in a number of locations including Budapest, Hungary and in San Ramon, California, USA. Mr Tamás Vámos, MD, GE Healthcare, Hungary said, "Software has enormous potential to address some of the world's biggest challenges in healthcare. Our investment in the team in Szeged is a great milestone and demonstrates our commitment to innovation and excellence in healthcare IT. In Hungary, we have established outstanding teams of software engineers; today, one in four patients worldwide is diagnosed using imaging software that was developed by our teams here. The expansion of the team in Szeged will enable us to accelerate our work." The collaboration between GE Healthcare and the University of Szeged has already led to the development of a new imaging technology platform for the imaging of liver disease. Showcased at the Radiological Society of North America's 2014 meeting, the industry's annual show which attracts radiologists from all over the world - Hepatic VCAR is post-processing CT analysis software designed to assist clinicians with the segmentation and assessment of liver morphology and liver lesions, as well as their changes over time.   Mr Attila Ferik, director, Software Platform Engineering at GE Healthcare, said, "GE Healthcare's vision is to develop technologies and solutions that help healthcare providers reduce their costs while improving the quality of care for their patients. I'm delighted that we are announcing this expansion to our outstanding team of specialists in Hungary who will be working with our IT development teams worldwide in the development of our industrial internet medical platform. Our collaboration with the respected institution of the University of Szeged has a strong track-record of delivery, which reflects on its outstanding quality of academic expertise. It's fantastic that we're working together for a healthier Hungary and a healthier world."   ]]> https://biospectrumindia.com/news/97/7159/healthifyme-launches-calorie-tracking-via-twitter.html https://biospectrumindia.com/news/97/7159/healthifyme-launches-calorie-tracking-via-twitter.html Fri, 05 Jun 2015 11:46:31 +0530 Now anyone can send a tweet to @HealthifyMe with the hash tag #TweetToTrack and names of the foods/drinks they ate and HealthifyMe will respond back with the calorie and nutrition values for the same. For instance if a tweet "@HealthifyMe 2 idlis, Sambar #TweetToTrack" is sent, HealthifyMe responds back with "211 calories." HealthifyMe was the first one to launch a dedicated Indian calorie tracking app in 2013 on the Android PlayStore and with this innovation, it is extending its ability to twitter, which has over 22 million Indians. Mr Tushar Vashisht, CEO and co-founder of HealthifyMe said, "We are committed to promote healthy living and the motive of this campaign is to extend the power of our calorie tracker to all Indians who have access to twitter. Even those who do not have the HealthifyMe app can now get benefit from our comprehensive Indian foods database. This is one step further in our endeavour to Healthify India" HealthifyMe is owned by Caeruz Ventures and aims to simplify healthy living. At the heart of HealthifyMe's platform is the World's First & largest Indian Calorie Tracker, which allows users to track their food, exercise and weight, easily via their smartphone or computer while continuously analyzing the user's data and provide powerful insights that ensure that users stay within their calorie/nutrition budgets. HealthifyMe uses a combination of cloud-powered software (smartphone application), hardware (wearable activity trackers, weight trackers) and human assistance (nutritionists, trainers and yoga instructors) that helps people eat better, workout more, lose weight and become fit. The company claims that using experts and technology, today over 100,000 users have benefitted from HealthifyMe and met their goals - be it weight loss, eating healthy or staying fit. HealthifyMe is also used in clinical settings such as Apollo and Medanta in Delhi and Manipal Hospital in Bangalore in conjunction with the Endocrinology, Cardiology and Preventive Health Centers. ]]> https://biospectrumindia.com/news/97/5515/inspirata-enters-indian-market.html https://biospectrumindia.com/news/97/5515/inspirata-enters-indian-market.html Fri, 05 Jun 2015 09:30:00 +0530 This facility is an extension of its US operations and will be set up and run at cost of around $3 million. The new facility will be located at Bagmane Tech Park (BTP), according to the company. Inspirata, which originally formed in 2013 as 2DP by its founder Mr. Mark Lloyd, was incorporated in the US September 2014, has already completed groundbreaking work in the oncology field by developing an end-to-end Digital Pathology Workflow Solution that scans glass pathology slides, making the digital images available for high-resolution viewing and sharing anywhere in the world. The company in India is looking to partner with renowned cancer institutions and best-of-breed hardware and software vendors. To begin with Inspirata will hire 50 high-end software product development engineers, scientists and informaticists from the healthcare domain in the next 2 months.   Inspirata's pathology cockpit employs advanced computational image analytics algorithms called 'Companion Diagnostics' that pre-screen and highlight suspicious cells on the digital images of glass pathology slides, helping pathologists to more rapidly diagnose cases. According to market research firm MarketsandMarkets, the global digital pathology market is expected to touch US $437 million by 2018. The Indian development centre will deliver cutting-edge support to all three of its business units including digital pathology workflow solution, companion diagnostics and the cancer Information Data Trust, and also will work on data mining, data analytics and predictive software algorithms. Commenting on the initiative Mr Satish Sanan, CEO, Inspirata, said "The Indian R&D centre will play a very strategic and vital role in our endeavor to help speed up cancer diagnosis, research, teaching and most importantly provide doctors and patients with predictive data that will change the way cancer is diagnosed and treated. Bangalore has the right ecosystem to support our plans and hence our decision to locate one of our key initiatives here." These novel detection and diagnostic algorithms are at the leading edge of cancer research and are expected to transform how cancer patients are treated throughout the world. For example, the turnaround time for cancer detection and diagnosis will be shortened from 12-13 days to 2-3 days. Additionally, patients will have more rapid and affordable access to second opinions and consultations from a worldwide pool of pathologists who specialize in specific forms of cancer. The company's long-term vision is to also develop a Cancer Information Data Trust - an extensive database of cancer signatures cross-referenced to clinical treatment protocols and patient outcomes. This data is the Holy Grail for cancer patients because it can help predict disease progression and recommend therapies based on previous patient responses in similar cases. Statistically speaking, the number of cancer patients is expected to increase by 70 percent over the next two decades. This implies that current pathologists must be better equipped with technologies that facilitate rapid accurate detection, diagnosis, prognosis and treatment options. Research suggests that 14.1 million adults in the world were diagnosed with cancer in 2012 out of which 8.2 million deaths from cancer occurred. In India, out of the 1.8 million people living with cancer in 2012, about 683,000 deaths due to cancer were registered. Mr Mark Lloyd, EVP & founder, Inspirata, said, "Inspirata is borne out of the need to bridge the gap and will revolutionize the practice of pathology worldwide-not through incremental advances, but with transformative, intelligent solutions that leverage computer vision and big data." ]]> https://biospectrumindia.com/news/97/6313/now-test-your-eyesight-through-an-app.html https://biospectrumindia.com/news/97/6313/now-test-your-eyesight-through-an-app.html Thu, 04 Jun 2015 13:12:24 +0530 Researchers at the International Centre for Eye Health at the London School of Hygiene and Tropical Medicine, the University of Strathclyde and the NHS Glasgow Centre for Ophthalmic Research have designed and developed Peek (the Portable Eye Examination Kit), a smartphone-based system for comprehensive eye testing. The study shows that the results from the app tests carried out on 233 people in their own homes and repeated in eye clinics based in Kenya were as reliable as those from standard paper-based charts and illuminated vision boxes in an eye clinic. "With most of the world's blind people living in low-income countries, it is vital we develop new tools to increase early detection and appropriate referral for treatment. In this study, we aimed to develop and validate a smartphone-based visual acuity test for eyesight which would work in challenging circumstances, such as rural Africa, but also provide reliable enough results to use in routine clinical practice in well-established healthcare systems," said lead author Dr Andrew Bastawrous, lecturer in International Eye Health at the London School of Hygiene and Tropical Medicine and co-founder of Peek. He added, "Our ultimate hope is that the accuracy and easy to use features of Peek will lead to more people receiving timely and appropriate treatment and be given the chance to see clearly again." Peek consists of a series of apps and a unique piece of hardware called Peek Retina. This study focused on one of the apps, called Peek Acuity, which determines how clearly an individual sees. It features a "tumbling E" on screen, showing the letter E displayed in 1 of 4 orientations. The patient points in the direction they perceive the arms of the E to be pointing and the tester uses the touch screen to swipe accordingly, translating the gestures from the patient to the phone, as the image gets smaller. Tests (using Peek Acuity at a distance of 2m and a reduced 3m "tumbling E" Snellen chart) were carried out in the participant's home and in the central clinic on two consecutive days.   Average testing time was also measured and found that the familiar and commonly used Snellen test took 82 seconds compared with 77 seconds for Peek Acuity which shows that using Peek is as quick to use as traditional methods. The researchers are conducting other studies to determine the suitability of the tool in different contexts across a range of different handsets and operating systems, including a trial involving teachers testing over 20,000 schoolchildren. The study is published in the journal JAMA Ophthalmology.   ]]> https://biospectrumindia.com/news/97/6558/siemens-introduces-a-new-mri-system-.html https://biospectrumindia.com/news/97/6558/siemens-introduces-a-new-mri-system-.html Thu, 04 Jun 2015 08:29:00 +0530 Siemens Healthcare has introduced the Magnetom Terra 7 Tesla MRI system, designed to translate cutting-edge MRI research results into clinical application. It is said to be the world's first ultra-high field research system ready for future clinical use with planned CE and FDA authorization to market for selected neurological and musculoskeletal MR imaging applications. "I am extremely proud to announce the introduction of our new 7 Tesla scanner Magnetom Terra. It is the first 7 Tesla MRI scanner fully designed and manufactured by Siemens, with a completely new designed 7 Tesla magnet in its core," said Dr Bernd Ohnesorge, CEO, Magnetic Resonance at Siemens Healthcare. He added, "Now, Siemens is the only company to manufacture a complete human ultra-high field MRI system fully in-house." The new 7 Tesla MRI system provides the whole range of cutting-edge 7 Tesla research functionalities, and is based on the latest software platform syngo MR E11, identical to Siemens' latest flagship 3 Tesla MRI systems, to enable consistent usability and protocol exchange. Magnetom Terra's new actively shielded magnet is the lightest 7 Tesla whole body magnet, 50 percent lighter than previous actively shielded 7 Tesla magnet generations. It increases the potential for translating cutting-edge research capabilities into future clinical application for anatomical, functional or metabolic MR imaging. This specially designed 7 Tesla technology makes this possible by offering, up to eight channel parallel transmit technology for selective excitation and higher homogeneity in challenging body regions such as cardiac and abdominal; Up to 64 receive channels for higher coil density in the field of view to achieve higher acceleration factors, higher signal-to-noise ratio and higher spatial resolution, and a better coverage of the body regions of interest. It also offers high gradient strength of up to 80 millitesla per meter (mT/m) and a fast gradient switching rate of up to 200 Tesla per meter per second (T/m/s) for advanced studies with diffusion and functional MR imaging.   "Based on our long-standing experience and the largest innovation network in human ultra-high field MRI, Siemens is committed to further grow the footprint of 7 Tesla MRI in research and clinical application. I am confident that our Magnetom Terra will help explore new territories in MRI research and at the same time it's the world's first 7 Tesla scanner designed for clinical use," said Dr Bernd Ohnesorge.   ]]> https://biospectrumindia.com/news/97/7129/phenomenex-enhances-kinetex-core-shell-family.html https://biospectrumindia.com/news/97/7129/phenomenex-enhances-kinetex-core-shell-family.html Wed, 03 Jun 2015 09:28:00 +0530 Phenomenex, a global leader in the research and manufacture of advanced technologies for the separation sciences, introduces 2.6µm and 1.7µm EVO C18 particle sizes, expanding the company's Kinetex core-shell column family. The Kinetex EVO C18 columns provide a unique C18 selectivity offering excellent peak shape for bases, 100 percent aqueous stability and rugged pH stability from 1 to 12 by incorporating a patented organo-silica grafting process that utilizes uniform stabilizing ethane cross-linking. Kinetex EVO C18 delivers the performance advantages of Core-Shell Technology at low, neutral and high pH ranges, making it an excellent addition to any lab's current reversed phase column portfolio. The new, smaller particle sizes extend the versatility and scalability of this media, which was introduced initially in 5µm particles for HPLC and preparative HPLC work. Overall, Kinetex EVO C18 columns are suitable for virtually every industry that relies on chromatography, including pharmaceutical drug discovery and development, clinical research, forensic toxicology, food safety and quality and environmental analysis. The rugged EVO C18 columns are an extension of the Phenomenex Kinetex core-shell line, which delivers improved results, increased productivity, easy transferability and significant cost savings compared to traditional HPLC/UHPLC media. The new 2.6µm EVO C18 columns offer performance comparable to sub-2µm fully porous particles on both standard LC and UHPLC systems, but at lower backpressures. The new 1.7µm particle size is designed for use with UHPLC systems and delivers on average 20 percent greater efficiencies than fully porous media. Both of these new particle sizes are directly scalable to each other and to the existing 5µm size, making method transfer between UHPLC, HPLC and preparative HPLC techniques straightforward. "Customers have been very enthusiastic about the availability of core-shell performance at virtually any pH range," explained Mr Simon Lomas, strategic marketing manager for Phenomenex. "With these two new particle sizes, researchers can now achieve massive performance gains on their UHPLC and HPLC instruments while being able to take full advantage of high, low and medium pH conditions (pH 1-12) to influence selectivity." ]]> https://biospectrumindia.com/news/97/5912/netmeds-to-go-live-by-next-week-reports.html https://biospectrumindia.com/news/97/5912/netmeds-to-go-live-by-next-week-reports.html Tue, 02 Jun 2015 11:49:15 +0530 The online pharmacy is backed by MAPE Advisory Services and targets a market share of three to four percent by 2020. "We are looking at capturing three to four percent of the market share in five years," Netmeds promoter Mr Pradeep Dadha told PTI. He said, "If we manage this, we should be a $ 1 billion company by 2020." Reportedly, Netmeds will offer over-the-counter and prescription drugs online as well as pilot its 24-hour delivery in Chennai, from next week. "We will begin with 24-hour delivery next week in Chennai. Other cities will have a two to four days delivery schedule. By next year, we will be present in 16 cities and offer same day or next day delivery," said Mr Dadha.     ]]> https://biospectrumindia.com/news/97/5757/philips-launches-a-new-ventilator.html https://biospectrumindia.com/news/97/5757/philips-launches-a-new-ventilator.html Tue, 02 Jun 2015 11:23:15 +0530 Royal Philips has announced the Canadian launch of the Philips Respironics V680 Ventilator for hospital respiratory care, offering both invasive and non-invasive ventilation. The Philips Respironics V680 Ventilator was recently unveiled at the Canadian Society of Respiratory Therapists' Annual Conference in Calgary, Alberta. In consultation with clinicians, the Philips Respironics V680 Ventilator is designed for smoother transition from ventilation to natural breathing, which may help enhance patient care. "For nearly 125 years, Philips has been committed to delivering innovations that improve people's lives. The Philips Respironics V680 Ventilator is yet another example of Philips technology that is designed with the needs of both the patient and clinician in mind," said Mr Iain Burns, president, Philips Canada. He added, "From Healthy Living, Prevention, Diagnosis, to Treatment, Recovery and Home Care, Philips creates solutions that span the health continuum, and it's how we are delivering on our vision to make the world healthier through innovation." The Philips Respironics V680 Ventilator is the first ventilator to combine the Philips gold standard single-limb noninvasive ventilation (NIV) solution with a fully featured, dual-limb system. Designed to deliver advanced life support for critically ill patients in the Intensive Care Unit (ICU), the Philips Respironics V680 Ventilator is also designed to make it fast and easy to switch from invasive to noninvasive ventilation to streamline transitions. Personalized to each patient, the Philips Respironics V680 Ventilator can help deliver the right therapy at the right time. It is the only ventilator to provide continuous measurements of dynamic resistance, compliance, elastance, and plateau pressure in both single and dual-limb invasive and noninvasive modes. NIV has become a standard of care for the management of acute respiratory failure, but there is a risk of leaks around the mask that may interfere with ventilator performance. As a result, patient-ventilator asynchrony, defined as a mismatch between patient's inspiratory time and the ventilator insufflation time, may occur in nearly 25 per cent of intubated patients. These high rates of asynchrony can be associated with a higher incidence of weaning failure and tracheostomy, prolonged mechanical ventilation, fatigue, increased sedation needs and longer hospital stays.   The Philips Respironics V680 Ventilator joins Philips' existing portfolio of patient-centred hospital respiratory care solutions which includes the Philips Respironics V60; the Philips gold standard hospital dedicated noninvasive ventilator. The Ventilator is now available in Canada and several European markets. The US launch is pending 510(k) clearance.   ]]> https://biospectrumindia.com/news/97/5911/medtronics-cryoballoon-approved-in-the-us-europe.html https://biospectrumindia.com/news/97/5911/medtronics-cryoballoon-approved-in-the-us-europe.html Tue, 02 Jun 2015 11:20:51 +0530 Medtronic has announced that the Arctic Front Advance ST Cryoablation Catheter has received the US Food and Drug Administration (US FDA) approval for the treatment of patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation. In Europe, where the Cryoballoon has a broader indication, Arctic Front Advance ST Cryoballoon has received CE (Conformité Européenne) Mark for the treatment of patients with atrial fibrillation. An integral part of the Arctic Front Advance System, the third-generation cryoballoon has a 40 percent shorter tip than the previous generation, designed to help physicians visualize ablation success in real-time with the Achieve Mapping Catheter, as well as allow increased maneuverability for accessing some pulmonary vein anatomies. The Arctic Front Advance ST Cryoballoon is used in a minimally invasive procedure to isolate the pulmonary veins, which are a source of erratic electrical signals that cause atrial fibrillation. The device uses coolant rather than heat (radiofrequency). Cryoballoon technology is associated with shorter procedure times than point-by-point radiofrequency ablation and better treatment outcomes than drug therapies on the market. The Arctic Front Advance System has been shown to improve quality of life for patients and significantly reduce paroxysmal (sporadic) atrial fibrillation symptoms, with patients experiencing reduction in atrial fibrillation episodes, palpitations, fatigue, rapid heartbeat, swelling, and syncope4, and has become a widely adopted treatment for atrial fibrillation. "The next-generation Arctic Front Advance ST Cryoballoon builds upon the successful performance of the Arctic Front Advance System, and its shorter tip was designed in response to physicians' needs in a real-world, clinical setting," said Mr Reggie Groves, vice-president and general manager of the AF Solutions business, part of the Cardiac and Vascular Group at Medtronic. The Arctic Front Advance System is the only cryoballoon system approved in the US for the treatment of paroxysmal atrial fibrillation and in Europe for treatment of atrial fibrillation. It has been used to treat more than 120,000 patients in more than 50 countries worldwide.   ]]> https://biospectrumindia.com/news/97/4692/fujifilm-expands-its-healthcare-it-portfolio-.html https://biospectrumindia.com/news/97/4692/fujifilm-expands-its-healthcare-it-portfolio-.html Mon, 01 Jun 2015 12:01:47 +0530 FUJIFILM Medical Systems has expanded its healthcare IT portfolio, and is taking Vendor Neutral Archive (VNA) into new areas with its latest acquisition TeraMedica. It began by further enhancing the patient imaging record at the 2015 annual meeting of the Society for Imaging Informatics in Medicine (SIIM) on May28-30 in Washington, DC. "Fujifilm recognizes that VNA technology is becoming more important to the market," said Mr Jim Morgan, vice-president of Medical Informatics at FUJIFILM Medical Systems. He added, "Healthcare institutions and market shifts have created larger networks of facilities. Large hospital groups are coming together, disparate PAC systems are more common, and the use of electronic medical records has created central repositories of textual information. But what hospitals also want is to create a single repository for all their imaging data, in addition to other items like lab reports."  In addition to Synapse VNA, following is a summary of Fujifilm offerings, The cornerstone of Fujifilm's integrated solution is Synapse PACS. It enhances communication and optimizes productivity for radiologists in any imaging environment. The next generation of Synapse RIS, a Radiology Information System, will also be shown. Synapse RIS and PACS integrate seamlessly, allowing the radiologist to see scanned documents and history from within the PACS, and allowing the user to see images from within the RIS.   ]]> https://biospectrumindia.com/news/97/6589/siemens-introduces-xprecia-stride-coagulation-analyzer.html https://biospectrumindia.com/news/97/6589/siemens-introduces-xprecia-stride-coagulation-analyzer.html Thu, 28 May 2015 11:52:33 +0530 Siemens Healthcare Diagnostics has announced the launch of a portable coagulation analyzer, the Xprecia Stride Coagulation Analyzer. It delivers fast and reliable Prothrombin time testing (PT/INR) for point-of-care monitoring and management of oral anticoagulation therapy (OAT) with warfarin. The winner of the internationally respected Red Dot Award: Product Design for 2015, the analyzer includes a number of innovations and features. It weighs just 300g, and can be held at any angle and brought directly to the patient's finger for efficient and comfortable blood sample application. "The Xprecia Stride Coagulation Analyzer is among the most radical, user-friendly redesigns of a point-of-care coagulation analyzer since they became widely available more than 20 years ago," said Dr David Stein, CEO, Siemens Diagnostics Point of Care Business Unit. He added, "Our analyzer is designed to be safer, more efficient and more ergonomically friendly than the products available today. The Xprecia Stride Analyzer uses simple icons and animation in a color display more commonly found in smartphones than medical instruments. Receiving the Red Dot award validates this unique product design and reinforces our efforts to bring a highly usable, lab-accurate coagulation analyzer to the point of care." To help increase workflow efficiency and usability, an integrated bar-code scanner simplifies data capture for accurate calibration of new lot numbers prior to testing.   The Xprecia Stride analyzer uses fresh capillary (finger stick) whole blood and results are expressed in PT seconds or as a PT/INR (international normalized ratio). It utilizes the same Dade Innovin reagent used by Siemens central lab analyzers to minimize any potential for variability. Studies have shown the performance to be equivalent to a reference laboratory hemostasis system, with results available within minutes. Other features include easy data transfer to a computer; color display and animated step-by-step instructions to help guide the user during testing. When taken together, all of these innovations become more important as the use of point-of-care PT/INR testing becomes critical to a growing number of procedures and treatments that utilize anticoagulation therapy.   ]]> https://biospectrumindia.com/news/97/7571/philips-mit-collaborate-to-innovate-in-healthtech-space.html https://biospectrumindia.com/news/97/7571/philips-mit-collaborate-to-innovate-in-healthtech-space.html Wed, 27 May 2015 12:57:49 +0530 Royal Philips announced that it has signed a five-year research alliance with the Massachusetts Institute of Technology (MIT) aimed at developing innovative HealthTech solutions to address society's most pressing challenges in healthcare, as well as digital connected lighting systems to address the need to make cities more livable and sustainable. With a total budget of $25 million for the five-year term, this is the largest research alliance undertaken by the company in the region. It is an integral part of a broader Philips strategy to accelerate innovation and business growth. This also includes moving the company's research center to Cambridge, Massachusetts, allowing Philips to collaborate with other leading-edge institutes and partner companies as part of the area's rich innovation ecosystem. The move to Cambridge, within close proximity of the MIT campus, will allow Philips researchers to collaborate readily with MIT faculty and PhD students on jointly defined research programs, as well as participate in open innovation projects. Joint teams will work on advancements in HealthTech, for example to help improve the management of cardiovascular disease (CVDs) and the diagnosis and treatment of various types of cancer, focused on improving patient outcomes, while reducing costs. Through the alliance, Philips will gain access to MIT's experts and clinical partners, allowing the company to better explore applications for population health management through the use of patient-centric, high-resolution imaging, healthcare informatics and data analytics. "The Boston area is rich with innovative talent that is regularly applying new thinking to solving big societal issues and developing disruptive technologies that can address those issues in new ways; it's a culture and vision that is very much in line with that of Philips," said Mr Henk van Houten, global head of Philips Research. He further stated, "By moving to Cambridge and collaborating with MIT, its staff and its partners, Philips can work with some of the best minds in the world on healthcare delivery, looking at ways to better prevent, manage or treat common diseases across the health continuum. In addition, we will explore advancements in connected lighting systems that can improve energy-efficiency, safety, productivity and quality of people's daily lives." MIT associate provost Prof. Karen Gleason. "Working in close proximity, the Institute's researchers and experts at Philips will endeavor to develop new digital and health technologies that address key challenges in wellness and urban living. Through industrial alliances like this one, we also hope to ramp up the speed with which we move new technologies from the lab to impact." ]]> https://biospectrumindia.com/news/97/4173/ge-launches-a-portable-ultrasound-for-developing-nations.html https://biospectrumindia.com/news/97/4173/ge-launches-a-portable-ultrasound-for-developing-nations.html Wed, 27 May 2015 11:50:13 +0530 GE Healthcare has introduced new Vscan Access portable ultrasound system. With a simple touchscreen interface, rugged design and software tools to support clinical decision-making, Vscan Access is designed specifically for primary healthcare workers, such as midwives, general practitioners, paramedics and clinical officers, in low-resource settings to provide information to the user during pregnancy assessments. Vscan Access is currently being showcased for the first time at the 68th session of the World Health Assembly in Geneva, Switzerland.The new system is available in certain countries in Africa and South-east Asia. In 2010, GE made a commitment to the United Nations to develop evidence-based solutions for maternal and child health by 2015. Vscan Access is the latest in a portfolio of accessible ultrasound products to help meet that commitment. "Based on five years of collaborative field research with stakeholders in more than 20 countries, GE Healthcare understands the challenges Ministries of Health face in developing nations, including: physician shortages in high-mortality and low-resource areas, pregnant women not seeking antenatal care (ANC), and lack of access to appropriate diagnostic devices in the primary care setting," said Mr Anders Wold, president and CEO of GE Healthcare's Ultrasound business. He added, "Studies have shown ultrasound can help enable task-shifting to midwives for basic obstetric scanning, mobilize mothers to seek more ANC visits and improve pregnancy management through early detection and referral of pregnancy complications." Features of the Vscan Access designed with the input of and for healthcare providers in developing nations also include a lightweight, portable, damage-and-dust-resistant design, battery-operation with flexible charging options, as well as Bluetooth wireless connectivity so data can be transferred to patients' referral facilities or remote experts easily. Software innovations such as pregnancy education, videos for patients, a multi-lingual user interface, and a reference library of scan images to support novice users of ultrasound, were also developed with the primary care end-user in mind.         ]]> https://biospectrumindia.com/news/97/7052/ema-confirms-recommendation-to-suspend-medicines-over-flawed-studies-by-gvk-biosciences.html https://biospectrumindia.com/news/97/7052/ema-confirms-recommendation-to-suspend-medicines-over-flawed-studies-by-gvk-biosciences.html Tue, 26 May 2015 12:28:46 +0530 The European Medicines Agency (EMA) has confirmed its recommendation to suspend a number of medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. This is the outcome of a re-examination requested by marketing authorization holders for seven of the medicines concerned. EMA's Committee for Medicinal Products for Human Use (CHMP) had adopted its original recommendation in January 2015 following an inspection of GVK Biosciences' site at Hyderabad by the French medicines agency (ANSM) that raised concerns about how GVK Biosciences conducted studies at the site on behalf of marketing authorization holders. The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated.   During the re-examination, the CHMP concluded that concerns about reliability of the clinical studies remain and therefore maintained its recommendation of January 2015 to suspend medicines for which no supporting data from other studies were available. This is with the exception of one medicine included in the re-examination for which concerns about studies were addressed. This medicine is now no longer recommended for suspension. As a result of the CHMP's January 2015 opinion and the re-examination, around 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site remain recommended for suspension. For around 300 other pharmaceutical forms and strengths, sufficient supporting data from other sources had been provided; these medicines will therefore remain on the market in the EU. The updated list of medicines for which the CHMP recommends suspension is available on the EMA website.   The CHMP noted that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad. Some of these medicines may remain on the market in some countries if they are of critical importance for patients because alternatives cannot meet patients' needs. The decision on whether a medicine is critical for patients lies with the national authorities of EU Member States depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data. EMA and national authorities work closely with international partners to ensure that studies underpinning marketing authorizations in the EU are carried out to the highest standards and that the companies involved comply fully with all aspects of Good Clinical Practice (GCP).   The CHMP's recommendation will now be sent to the European Commission for a legally binding decision. This decision will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines. ]]> https://biospectrumindia.com/news/97/6414/quintiles-offers-a-new-solution-to-biopharma-cos.html https://biospectrumindia.com/news/97/6414/quintiles-offers-a-new-solution-to-biopharma-cos.html Tue, 26 May 2015 11:39:41 +0530 To help emerging biopharmaceutical companies in the Asia Pacific region, achieve their growth aspirations, Quintiles has launched a new solution set. It is tailored to meet the needs of emerging companies in the world's most diverse and dynamic healthcare market. "Asia-Pacific is poised to become the world's next biopharma powerhouse, not least because of its growing number of emerging companies with promising pipelines. These companies face formidable challenges as they look to expand into markets or therapeutic areas in which they may have limited or no experience," said Dr Ross Horsburgh, senior vice-president and head of Clinical Development, Asia-Pacific, Quintiles. The Quintiles Asia-Pacific Emerging Biopharma solution includes, dedicated local project leadership based in Asia-Pac with knowledge of local markets, customs and language; Custom-tailored operational models to meet individual customer priorities and use Quintiles' world-class processes and platforms and accelerated patient recruitment through our global network of 25 Prime and >1,200 Partner sites - with seven of those Prime Sites located in Asia-Pacific. The Asia-Pacific solution gives emerging companies access to Quintiles' data-driven insights; its knowledge of local markets; its in-depth therapeutic and scientific expertise; and its global drug development platform. It further adds to Quintiles' solutions for emerging companies, which includes Novella Clinical, a specialty CRO focused on the needs of small to mid-sized oncology companies and medical device and diagnostic companies.     ]]> https://biospectrumindia.com/news/97/6464/regulate-prices-of-cardiac-stents.html https://biospectrumindia.com/news/97/6464/regulate-prices-of-cardiac-stents.html Fri, 22 May 2015 12:15:03 +0530 Maharashtra's Food and Drug Administration (FDA) has said that it has asked the National Pharmaceutical Pricing Authority (NPPA) to regulate high prices of cardiac stents. "It has come to FDA's notice that demand for cardiac stents has increased considerably and also the fact that cardiac stents are being exorbitantly priced," said Mr Harshadeep Kamble, FDA commissioner, in a statement. "There were complaints from the public and also from non-governmental organisations (NGOs) regarding overpricing and overcharging of cardiac stents to needy patients," said the senior IAS official. Following the complaints, the FDA's Vigilance Branch conducted a detailed probe against a major importing company dealing in cardiac stents. The investigation has revealed that the MRP itself is exaggerated and to the tune of more than 300 to 700 percent of the actual cost of importing cardiac stents by the importing company.   "The profit margin earned by the importing company with respect to its distributors on an average is about 120 percent and the average profit margin earned by distributors to the hospital is about 125 percent," said Mr Kamble.   ]]> https://biospectrumindia.com/news/97/6275/transasia-introduces-sysmexs-new-product.html https://biospectrumindia.com/news/97/6275/transasia-introduces-sysmexs-new-product.html Thu, 21 May 2015 12:38:00 +0530 Sysmex Corporation has launched a Sysmex XN series hematology analyzer. The new Sysmex XN series is equipped with a White Precursor Cell (WPC) channel to differentiate abnormal lymphocytes and blasts by using the optical detection system and Fluoroscence flowcytometry. The products are marketed in India, exclusively by Transasia Bio-Medicals. A study (published in December, 2013, in the International Journal of Laboratory Hematology) conducted by the scientists at the National Cancer Center Hospital (Tokyo, Japan) concluded that the HPC count obtained on a Sysmex XN analyzer correlates accurately with the enumerated CD34 cells. Cells expressing the CD34+ and hematopoietic progenitor cells (HPCs) were compared in 76 granulocyte colony-stimulating factor (G-CSF) mobilized blood or apheresis samples taken from 18 healthy donors and 6 patients undergoing autologous PBSCT. CD34+ cells were isolated using MACS magnetic cell separation kits (MiltenyiBiotec - BergischGladbach, Germany). Thus, The Sysmex XN analyzer can carry out an HPC enumeration without the use of monoclonal antibodies, Sensitivity of flagging of blasts is enhanced in the WPC channel of the instrument. It gives a clear demarcation between the blasts and the abnormal lymphocytes, the total number of HPCs in the final products, as well as from pre apheresis PB and intermediate products during apheresis, can be used to predict the final amount of collected CD34+ cells, the detection and number of HPC in the peripheral blood could possibly provide a standard and rapid alternative for predicting the yield of stem cells collected by apheresis.   ]]> https://biospectrumindia.com/news/97/5525/ce-mark-for-abbotts-stent-absorb-gt1.html https://biospectrumindia.com/news/97/5525/ce-mark-for-abbotts-stent-absorb-gt1.html Thu, 21 May 2015 12:11:03 +0530 Abbott has announced that it has received a CE Mark for the latest advancement of its Absorb stent system, Absorb GT1. It combines the world's first fully dissolving stent with a next-generation delivery catheter to help doctors treat people with heart disease. Built upon three generations of delivery catheter innovations, Absorb GT1 refers to the GlideTrack catheter, Abbott's most advanced stent delivery system. It is designed to make it easier for doctors to access and treat diseased vessels in people with coronary artery disease (CAD). The GlideTrack catheter incorporates several design and technology changes that have the potential to improve deliverability and performance. Last year, Abbott had announced positive one-year clinical results from ABSORB II, the world's first prospective, randomized, controlled trial. It compared the safety and effectiveness of the fully dissolving Absorb heart device to the company's market-leading, metallic XIENCE family of drug eluting stents. In one year, overall clinical outcomes for Absorb were comparable to XIENCE. The trial, conducted primarily in Europe, included 501 people with CAD. "Coronary artery disease is the most common disease in developed countries, and the new Absorb GT1 catheter delivery system may improve the ability of doctors to treat more people with CAD by opening up coronary blockages in hard-to-reach areas with this novel, fully dissolving stent," said Dr Charles Simonton, chief medical officer and divisional vice-president, Medical Affairs, Vascular, Abbott. He added, "Abbott is committed to developing scientific and technological innovations that help people regain their health and get back to their lives, and this latest Absorb advancement will allow more people to benefit from this breakthrough medical technology." Absorb is currently available in more than 70 countries worldwide. Absorb is an investigational device in the US and not approved for the commercial use.     ]]> https://biospectrumindia.com/news/97/7683/dadha-pharma-to-launch-online-pharmacy-net-meds-in-chennai.html https://biospectrumindia.com/news/97/7683/dadha-pharma-to-launch-online-pharmacy-net-meds-in-chennai.html Thu, 21 May 2015 10:59:36 +0530 A hundred-year-old pharma distribution company in Chennai has decided to enter the ecommerce space. Dadha & Company, a name that is said to be synonymous with pharmacy distribution throughout the south of India will now reduce its destination barriers by capitalizing on the internet's vast potential to reach out to a larger pool of people. Last week, Bengaluru-based investment bank MAPE Advisory Group, which advises on private equity funds and M&A deals, announced its plans to invest in a yet-to-be launched online pharma chain Net-Meds Marketplace Private Ltd. MAPE Advisory along with Dadha Pharma's founder Pradeep Dadha will initially invest Rs 30 crore inNet-Meds, with a further commitment to increase it to Rs 60 crore.  Headquartered in Chennai, Dadha Pharma Private Limited was founded in 1914 by Mohanchand Dadha's forefathers. Since its inception, the company's profile speaks as a trusted source for pharmaceutical supplies. The company's Senior Director, S Mohanchand Dadha is a third generation entrepreneur with vast industry and financial experience and is a long-standing member of the Board of Directors of Sun Pharmaceutical Industries Ltd. The online pharmacy Netmeds.com, is owned and operated by Netmeds Marketplace, Ltd. a licensed pharmacy. Netmeds is an ecommerce portal where consumers with valid prescriptions can upload their prescriptions, via scan or pic, by email or Whatsapp, and once the prescription is validated by Netmeds pharmacists, consumers can shop for their medicine, both branded and low-cost generic variants, for all chronic conditions like diabetes, high cholesterol, blood pressure, and cardiovascular diseases. The company has collaborated with Indian Post to ship the medicines to the consumers within 2 to 4 days across India. Netmeds plans to launch its website later this month and is putting final touches to its marketing campaign, which it plans to launch simultaneously. It will sell prescription and over-the-counter (OTC) drugs, supplying over 15,000 stock keeping units (SKUs) across India from its warehouse in Chennai. Commenting on the launch, Net-Meds' co-promoter Bruce Schwack explained, "We know that this new modality through NetMeds is going to make it more convenient for people to take care of themselves, and more so, to enable caretakers to conveniently access the medicine their parents and grandparents need, make sure they don't run out, avoid all the hassle of going to the pharmacy, traffic, parking, monsoons, stock issues, and many more difficulties will be eliminated." He further added, ""Also, think of the 2nd- and 3rd-tier cities and the even more agrarian, or rural locales, where some medicines may not be readily available. Now, as long as there is a smart phone and postal service, they will get their medicines through NetMeds online pharmacy service." Net-Meds' launch comes close on the heels with MedPlus launching its online pharmacy service in Chennai. In April 2015, MedPlus, one of India's leading pharmacy retail chain, launched its online service - 'Click, Pick & Save' in Chennai. MedPlus aims to double its market share in Tamil Nadu by expanding its footprint of over 250 stores to around 500, and also aims to combine it with online service to harness the benefits of e-commerce. Recently, in April this year, HealthKartPlus an online pharmacy managed to secure Rs 32 crore in a fresh round of funding. The funding was led by MakeMyTrip founder Deep Kalra along with other investors such as Sequoia Capital, Omidyar Network, Intel Capital and Kae Capital. The funds were raised with a focus to scale up the business and expand its reach to cities like Mumbai, Hyderabad, Chennai, Pune and Chandigarh by the end of 2015. Currently, HealthKartPlus is operational in Delhi-NCR only. Earlier in March, former Igate CEO Phaneesh Murthy floated a new online pharmacy venture, PM Health and Life Care that aims to connect multiple providers of healthcare services to consumers in Bengaluru. The family fund of Phaneesh Murthy has led the seed round of $3.2 million. In the venture, Phaneesh is going to actively play the role as Executive Chairman. The venture plans to raise its first round of capital shortly bringing the total invested amount in the company to about $8- $10 million. In the near future, the company will set out its plan to expand into other metros. It is now evident that the online pharmacy distribution trend in India has been set. With experienced pharmacy retailers adopting ecommerce, a variety of value-added-services are being incorporated by the organized players in the sector to attract a larger market share. There is plenty of room for the newcomers and existing players like Apollo Pharmacy's online distribution to grow. The success of each of these players will be closely watched. ]]> https://biospectrumindia.com/news/97/4307/patients-first-iscrs-theme-on-international-clinical-trials-day.html https://biospectrumindia.com/news/97/4307/patients-first-iscrs-theme-on-international-clinical-trials-day.html Wed, 20 May 2015 13:13:20 +0530 The ISCR has chosen the theme of "Patients First" for this year's International Clinical Trials Day that will be observed on May 20. A series of workshops and seminars would be held to highlight and celebrate the very important role that patients play in clinical trials and how their safety and welfare are a top priority for all clinical research stakeholders. As per Ms Suneela Thatte, president, ISCR, "On the International Clinical Trials Day, we acknowledge the selfless contribution of clinical trial patients in inventing new drugs and treatments. We would also like to dedicate this very important day to patients who are still waiting for new breakthroughs in medical science for a better quality of life. At less than 1.5%, the share of India in global clinical trials is very low, despite the country accounting for 17% of the world's population and 20% of the global disease burden. We will be organizing several workshops and seminars on May 20 to deliberate upon the current environment for clinical trials in India and how clinical research stakeholders can collaborate to ensure an enabling environment for clinical research in the country." Suneela Thatte added: "Over the last few months, several steps have been taken by Indian regulators to bring clinical research in India back on track. We now need to restore confidence among all the stakeholders that robust and streamlined guidelines and systems are in place in the country for conducting clinical research. Thousands of patients are desperately waiting for new therapies and drugs to enter the market, and we, as clinical research professionals, have an enormous responsibility to fulfill this need. We are fully committed to working with everyone across the clinical research spectrum to create an enabling environment which encourages scientific and ethical clinical research so that patients can have better and quicker access to new treatments." New Launches on May 20 by ISCR To create an enabling environment for clinical research by raising awareness about its role and relevance, ISCR has launched a nationwide advocacy program called NavChetana. On May 20, ISCR will be relaunching its publication called "Clinical Trials - A Guide for Participants" under the NavChetana banner. The Guide empowers patients by providing a better understanding of clinical trials so that they can make a responsible and informed decision to participate. It guides patients on questions to ask investigators before making a decision to participate in clinical trials.   ISCR will also be launching an educational film on the occasion, showcasing clinical research testimonials and experiences. In addition, it will be distributing its Code of Conduct for Clinical Research in India. This 12-point, patient-centric code, applicable to all ISCR members, reinforces their commitment to ethical, scientific and regulatory compliance while engaging in any clinical research activity. Said Suneela Thatte: "As a professional organization representing clinical research professionals, ISCR fully supports a more robust and regulated clinical research environment to ensure highest standards of ethics and quality and protect patient rights. We seek media support in acknowledging the role of clinical trial patients who are unsung heroes and highlighting the experience and struggles of today's patients, particularly those suffering from unmet medical needs. We need to build an environment that fosters clinical research, drug discovery and innovation through public education and awareness." International Clinical Trials Day is celebrated on May 20 each year. On this day in 1747, Dr James Lind, a Scottish physician, conducted the world's first controlled clinical trial aboard a ship on sailors suffering from scurvy. The patients were given the same general diet, but supplemented with additional items such as cider, elixir vitriol, vinegar, seawater, nutmeg and (crucially) oranges and lemons. In just six days, those sailors taking citrus fruits became fit for duty. In this manner, Dr Lind discovered the fact that citrus fruits (Vitamin C) in the diet could prevent scurvy. He is now regarded as the father of clinical trials. And like those sailors 268 years ago, several hundreds of thousands of healthy volunteers and patients have since then contributed to the development of new treatments and drugs by participating in clinical trials. ]]> https://biospectrumindia.com/news/97/4378/sartorius-procontrolenterprise-goes-mobile.html https://biospectrumindia.com/news/97/4378/sartorius-procontrolenterprise-goes-mobile.html Wed, 20 May 2015 11:31:32 +0530 SPC@Enterprise, Sartorius Intech's offering, has been moved to the mobile platform. Already available in the market and known for its use in process control and quality assurance, the software platform has now been updated to seamlessly integrate with all mobile devices. They will be used as input and output terminals. The update helps consumers react faster to drops in production efficiency, cutting down resource wastage and production costs. The device works by taking information from across the production line. It offers a detailed analysis of how to improve operational excellence. The new step taken to improve efficiency ensures that the SPC@Enterprise is compatible with Microsoft SQL databases and operating systems. This allows manufacturers to access processes from anywhere through cloud or otherwise. It is also useful to food manufacturers because of its compliance with IFS, BRC and ISO22000. The SPC@Enterprise has also been made compliant with Windows 8/8.1. The third version of the software will work on windows 10 devices. ]]> https://biospectrumindia.com/news/97/7049/india-can-lead-in-big-data-analytics-philips.html https://biospectrumindia.com/news/97/7049/india-can-lead-in-big-data-analytics-philips.html Tue, 19 May 2015 16:50:09 +0530 The symposium was delivered by Mr M R Srinivas Prasad, â€?CEO, Philips Innovation Campus, Bangalore; and Mr J Vijayananda, senior director, analytics healthcare, Philips. Mr Srinivas held that the Indian healthcare is at an inflection point. "Healthcare is one of the biggest challenges in India, both from infrastructure and population or disease management perspective. It (India) has the potential to lead the rest of the world. 8 percent of our GDP comes from IT, and 10 percent from the automobile sector. The US spends most of its GDP towards healthcare," he revealed. He believes that technology adoption has always been driven by challenges. "The Indian healthcare industry is poised at this point," he said. There is an increase in the rise of diseases like cardiovascular diseases (CVDs), diabetes, hypertension, respiratory disorders and obesity in India. "10 percent of Indian population is going to be afflicted by these diseases. That's about 120 million people," Mr Srinivas opined.   Currently, in India, 86 percent of the population pays its treatment costs out-of-pocket, and only 14 percent of them have healthcare insurance. "Hence, we have millions of households going bankrupt due to exorbitant costs involved in treating diseases," he commented. Managing diseases calls for screening and diagnosing them early. "There is a belief that healthcare access in rural areas are much lesser than their urban counterparts. That's not true. Affordability is much higher than availability," pointed Mr Srinivas. There are two critical questions that need to be answered while dealing with predicting diseases and increasing healthcare access in rural areas: How can predictability help without compromising on the treatment quality at lower costs? How can rural population have the same access to healthcare that is available in big metros? Here, Big Data can play a major role in addressing critical bottlenecks including unavailability of infrastructure, paucity of resources like medical professionals, and chronic diseases. Known for having lesser number of hospitals, India has only 500-600 intensivist, Mr Srinivas said. If Big Data is used to predict diseases, then the Data needs to be managed efficiently. By applying suitable advanced algorithms, Big Data can be used to make decision and take necessary action. Another speaker, Mr Vijayananda, said that there are two aspects to Big Data analytics: Big Data and Analytics. "Big data has 4 aspects defined by 4 V's. Volume of the data, velocity in terms of rate at which data is received, veracity and consistency of the data and the variety of data," he educated. The Analytics part deals with derivation of value with the available data including descriptive analytics, diagnostic analytics, operational analytics, predictive analytics and prescriptive analytics. "Using big data, the workflow efficiency in hospitals can be improvised, along with improvement in the efficiency of devices, minimizing patient readmissions, carrying out Cohort Analysis and population management," Mr Vijayananda observed. At the same time, Mr Srinivas remarked, "India can be a leader in big data analytics and lead other countries. When there is paucity of resources, it has to be ensured that the system becomes efficient. There is a lot of thrust on health in the 12th five-year-plan and the current government has also laid much emphasis." Currently, US, China, the UK, India and Japan are said to be thriving markets in Big Data analytics. As a trend, there are lots of start-ups coming up in the Big Data analytics ecosystem. "Awareness now is a lot better than what it was in terms of adopting new technologies," Mr Srinivas highlighted. Big Data and using real-time analytics decision-making has been the biggest advances ever since we started using the computers, he stated. In Big Data, experts believe that the major challenges are unstructured data, shortage of data scientists, interoperability, and data security and privacy. "Big Data is a technology and real-time decision-making will help address problems in terms of making hospitals efficient and enabling clinicians make better decisions with better treatment outcomes," expressed Mr Srinivas. "It is not an easy road. But it is an opportunity for India to take the lead. As we create more awareness, and more people are informed, we will see more revolution, and hence we are witnessing more start-ups in this area. In the last couple of years, the number of start-ups focusing on data science and analytics have increased. And they are serving mostly the developed markets because the market here is still nascent and the government has to provide good support," Mr Srinivas noted. According to Philips, the company is talking to the government and stakeholders since it believes the country needs to harness the potential of Big Data, especially with the onset of CVDs. "In the coming years, 70 percent of the global CVDs is going to be from India. It is already late now, we need to do something," Mr Srinivas urged. ]]> https://biospectrumindia.com/news/97/5528/india-has-less-than-1-5-share-of-global-clinical-trials-iscr.html https://biospectrumindia.com/news/97/5528/india-has-less-than-1-5-share-of-global-clinical-trials-iscr.html Mon, 18 May 2015 13:58:50 +0530 ISCR is an association of clinical research professionals that aims to build awareness of clinical research as a specialty in India. A series of workshops and seminars would be held by ISCR to highlight and celebrate the very important role patients' play in clinical trials and how their safety and welfare are a top priority for all clinical research stakeholders. Said Ms Suneela Thatte, president, ISCR, "On the International Clinical Trials Day, we acknowledge the selfless contribution of clinical trial patients in inventing new drugs and treatments. We would also like to dedicate this very important day to patients who are still waiting for new breakthroughs in medical science for a better quality of life. At less than 1.5%, the share of India in global clinical trials is very low, despite the country accounting for 17% of the world's population, and 20% of the global disease burden. We will be organizing several workshops and seminars on May 20 to deliberate upon the current environment for clinical trials in India and how clinical research stakeholders can collaborate to ensure an enabling environment for clinical research in the country." Over the last few months, several steps have been taken by Indian regulators to bring clinical research in India back on track. "We now need to restore confidence among all the stakeholders that robust and streamlined guidelines and systems are in place in the country for conducting clinical research. Thousands of patients are desperately waiting for new therapies and drugs to enter the market, and we, as clinical research professionals, have an enormous responsibility to fulfill this need. We are fully committed to working with everyone across the clinical research spectrum to create an enabling environment which encourages scientific and ethical clinical research so that patients can have better and quicker access to new treatments," she added.   To create an enabling environment for clinical research by raising awareness about its role and relevance, ISCR has launched a nationwide advocacy program called NavChetana. On May 20, ISCR will be relaunching its publication called "Clinical Trials - A Guide for Participants" under the NavChetana banner. The Guide empowers patients by providing a better understanding of clinical trials so that they can make a responsible and informed decision to participate. It guides patients on questions to ask investigators before making a decision to participate in clinical trials. ISCR will also be launching an educational film on the occasion, showcasing clinical research testimonials and experiences. In addition, it will be distributing its code of conduct for clinical research in India. This 12-point, patient-centric code, applicable to all ISCR members, reinforces their commitment to ethical, scientific and regulatory compliance while engaging in any clinical research activity. Said Ms Suneela Thatte: "As a professional organization representing clinical research professionals, ISCR fully supports a more robust and regulated clinical research environment to ensure highest standards of ethics and quality and protect patient rights. We seek media support in acknowledging the role of clinical trial patients who are unsung heroes and highlighting the experience and struggles of today's patients, particularly those suffering from unmet medical needs. We need to build an environment that fosters clinical research, drug discovery and innovation through public education and awareness." ]]> https://biospectrumindia.com/news/97/6772/medical-device-imports-bill-may-hit-4-billion-by-2018-19.html https://biospectrumindia.com/news/97/6772/medical-device-imports-bill-may-hit-4-billion-by-2018-19.html Mon, 18 May 2015 12:57:41 +0530 Imports of medical devices and equipment in India is expected to grow from $2.3 billion in 2013-14 to $4 billion by 2018-19, according to a study by The Associated Chambers of Commerce and Industry of India (ASSOCHAM). As per the report, Gujarat accounted for the highest share of over 18 percent, in terms of total number of 316 factories operating in the medical and dental instruments and supplies sector across India, according to the sector specific analysis. "Absence of a clear and consistent regulatory framework, lack of adequate incentives and funding for manufacturing devices and absence of medical devices' specific legislation are certain key constraints faced in establishing this industry in India,"said mR D S Rawat, secretary general of ASSOCHAM. In its study, ASSOCHAM has suggested that the Government needs to expedite the process of relaxing FDI policy for cash-starved medical devices sector attract more investments and boost domestic manufacturing.   ]]> https://biospectrumindia.com/news/97/6473/cole-parmer-expands-its-digi-sense-line.html https://biospectrumindia.com/news/97/6473/cole-parmer-expands-its-digi-sense-line.html Sun, 17 May 2015 11:40:00 +0530 Cole-Parmer, a global leader experience in fluid handling, electrochemistry, laboratory equipment and supplies announced the expansion of its precision instruments line, the DigiSense. The new instruments included in the line are for convenient temperature measurement, equipment testing, and inspection. The instruments available in this product line, also called "Be Sense-ible" are a full range of environmental and temperature instruments that include thermocouple meters, thermistor meters, RTD meters and infrared thermometers. Many of these instruments are calibrated and ready to use. The new products are as follows: 1. Digi-Sense Precalibrated Humidity and Temperature Indicator monitors humidity levels and displays temperature and time as well.2. Digi-Sense Precalibrated Pocket Thermometers in large head, pen style, and folding probe types take fast and accurate temperature measurements anywhere. 3. Digi-Sense Precalibrated Pocket-Size Moisture Meter measures the moisture level in wood products and hardened materials. 4. Digi-Sense Precalibrated Digital Contact/Photo Tachometer ensures that the equipment is in optimal operating condition. 5. Digi-Sense Borescope and Video Borescope - ideal for inspecting duct work, wiring, piping, vehicles, and other hard-to-reach areas. ]]> https://biospectrumindia.com/features/97/4387/demand-for-cell-isolation-techniques-to-increase-manifold.html https://biospectrumindia.com/features/97/4387/demand-for-cell-isolation-techniques-to-increase-manifold.html Sun, 17 May 2015 09:30:00 +0530 The Asia-Pacific (APAC) is the fastest growing region in the global cell separation market, due to rapid development of healthcare infrastructure and increasing medical tourism. As per market report published by Transparency Market Research (TMR) in 2012, stem cells research and cancer research comprised approximately 52 percent of the overall cell separation technologies market. Global rise in research activities in the field of stem cells and cancer, due to rapidly increasing prevalence worldwide, and predictable benefits of stem cells in medical industry have flourished the demand for cell separation technologies. "North America is expected to retain its dominance from 2012 to 2019. Rapid adoption of advanced technologies and well-defined regulatory framework are major factors which will drive the North American cell separation technologies market," emphasized Ms Snehal Deshmukh, a senior research analyst at TMR. APAC is a lucrative market for cell separation technologies. However, emerging economies in this region will play a key role in the development of cell separation technologies market.   This is due to growing focus of the respective government on the improvement of biotechnology industry, availability of increased funds towards research activities, offering public-private partnerships to international players to enter into the domestic market, which are seen as attractive factors for global researchers to this region, say analysts in the industry. What's in and what's hot Recently, the trend is shifting towards the use of microfluidics in cell isolation. "Advancement in microfluidic technology has provided robust solutions for isolation of cells which are present in low quantity in the body. Microfluidic chips are easy to use, and provide reliable and efficient isolation of cells even from a small volume of sample," stated MarketsandMarkets (M&M), a market research firm. Citing the potential of microfluidic technology in cell isolation, various research studies are being performed for evaluating the performance of microfluidic chips in isolating other types of cells.   In this regard, in August 2013, Qiushui Chen and his team published a study in Scientific Reporter regarding the efficient usage of microfluidic technology for isolating stem cells. M&M noted that the increasing application of microfluidic technology in cell isolation will help in overcoming the present challenges in this market, which in turn will present significant opportunities for the market growth. Several companies operating in the cell separation technology market are shifting focus from research laboratories to clinical research and translation laboratories, to offer their products such as reagents, instruments and other tools used in cell separation process. In addition, companies are focusing on partnerships, collaborations, new product launches, and acquisitions to attain a leadership position in the market, M&M said. Global rise in the morbidity and mortality rate of chronic diseases such as cancer, diabetes and arthritis has become areas of concern for healthcare professionals, and thus the demand for cellular therapy to treat such diseases is rapidly increasing.   Another research analyst, Ms Shraddha Pashankar from TMR opined that rising demand for cellular therapy will fuel the growth of research activities worldwide, and thereby escalating cell separation technologies market globally. "Furthermore, stem cell research, immunology, neuroscience research and cancer research are major application areas of cell separation technologies," she added. Challenges for new entrants Currently, the isolation of highly purified cells in high quantity from low volume sample is a major challenge faced by researchers and clinicians. For instance, recovering T regulatory cells in high volume from limited volume sample is a cumbersome process due to the lack of specific cell surface markers on these cells. Furthermore, these cells are found in low frequency in peripheral blood which makes the process more burdensome. Analysts at Persistence Market Research (PMR) remarked that complexities related to reagents development will pose another major challenge. Moreover, reluctance amongst researchers in emerging economies to use advanced cell isolation techniques is another burden faced by the cell isolation market, highlighted analysts at M&M. The use of advanced cell isolation techniques is largely dependent on the cost of the instrument and technical know-how. Due to budget constraints and dearth of technical know-how, users in emerging countries are relatively reluctant to adopt new techniques such as automated magnetic cell separators and flow cytometers.   The survival of small players and new entrants in the cell isolation market is another challenge. Huge investments are required to enter into this market. "This particular market demands continuous improvement of existing products and technologies as well as the launch of novel products. Thus, to remain competitive, companies have to invest heavily in R&D which is very difficult for small players and new entrants," observed M&M. Booming Asian markets Relatively untapped Asian market is a major opportunity for cell separation technology market. "Emerging economies are expected to become a focal point for the growth in the cell isolation market. Taking into consideration the growth opportunities in the Asian market, major companies are expanding their presence in this region," commented M&M.   For instance, in August 2013, Beckman Coulter Life Sciences acquired the flow cytometry business assets of ReaMetrix India. Moreover, biopharmaceutical and pharmaceutical companies are increasingly focusing on drug discovery outsourcing. M&M attributes this to the ever-increasing demand for better drugs, drying drug pipelines, and rising R&D costs. "The Asian markets, especially China and India, have a large number of CROs that offer drug discovery services for pharmaceutical and biotechnology companies. As a result, the demand for cell isolation techniques is expected to increase in the Asian region and will present an array of opportunity for the cell isolation market to flourish," it reasoned. Also, public-private organizations are increasingly providing numerous grants and funds to researchers and research institutes for their stem cell-related projects. For instance, BD Biosciences annually provides reagents worth US $1,00,000 to 10 scientists, who pursue innovative ideas in stem cell research. "Taking into consideration rapidly increasing research and development activities worldwide, application area of cell separation technologies is expanding with every innovation entering into the market," held Ms Snehal. On the other hand, PMR stressed that the need for solutions with higher purity yield, lesser turn-around time, and simplicity at cheaper rates will offer wide range of opportunities in this area. Revolutionizing new technologies The cell separation technologies work on technologies such as gradient centrifugation and surface marker separation. Surface marker separation is further segmented as magnetic activated cell sorting (MACS) and fluorescence activated cell sorting (FACS). MACS is the major technology segment, and FACS is expected to grow potentially, due to increased adoption of the technology in cell purity sensitive research area. The growing demand of this technology is due to its ability to separate even small molecules from a given sample. "Furthermore, FACS can be used on a large-scale for isolating desired cells from a large-cell suspension. It is widely used for separating white blood cells from other cells. The wide usage of this technique in the biopharmaceutical and biotech industries is a major reason for the growth of the market," commented M&M. MACS possess various advantages like using it for isolating cells from a small mixture easily and efficiently without disrupting the cells. Such advantages, along with the increasing adoption rate of MACS are major reasons for high growth. According to another market report published by TMR in 2012, MACS technology market comprised approximately 35 percent of the overall cell separation technologies market. "In spite of availability of many technologies, only gradient centrifugation, MACS and FACS technologies are commercially used for cell sorting. Other technologies such as lab on chip, microfluidic, field-flow-fractionation (FFF) and affinity-based cell sorting are in developmental stage for improvement of purity of the yield and reduce turnaround time," explained Ms Shraddha. Cost pressures Most analysts believe that the high cost of cell isolation instruments is a major hurdle. "Various cell isolation instruments such as flow cytometers and magnetic cell separators are equipped with advanced features and functionalities and thus are priced at a premium," explained M&M. The price of a flow cytometer varies from US $35,000 to $100,000. For instance, the price of a CyFlow Cube 6 (Partec) is approximately US $35,000. Stratedigm's SE500 flow cytometer is priced at approximately US $68,000 (source: The Scientist Magazine, May 2011). Biopharmaceutical companies require many such instruments and hence the overall cost of production of biopharmaceuticals increases significantly due to these expensive systems. Another hurdle faced by the cell separation market is the limited funds for embryonic stem cell isolation. M&M remarked, "Limited funding for embryonic stem cells is undermining the market potential of stem cell therapies and research." Countries such as Australia, Belgium, Singapore, Spain, South Korea, Sweden, and the UK have adopted tightly regulated but permissive approaches towards research involving the use of human embryos to generate embryonic stem (ES) cell lines. On the other hand, other countries such as the US and Germany have restricted the funding for stem cell research involving ES cell lines. For instance, in 2007, the California Institute for Regenerative Medicine (CIRM) funded 100 embryonic stem cell research projects. However, this number decreased to 6 in 2012. "Such restrictions on embryonic stem cells funding are likely to restrict research on stem cells, which in turn is expected to restrain the growth of the cell isolation market," pointed M&M. Regulatory woes vs product development The regulations for cell separation are mostly complicated due to legal technicalities. "The safety, performance, and consistent quality of cell separation are necessary facets that need stringent evaluation for international public health," said PMR. The regulations differ from country to country. For instance, in Singapore, the isolation and use of human embryonic stem cells, for therapeutic or research purpose, is only allowed when they are not more than 2 weeks old. In China, stem cell research is not practiced at clinical level due to strict regulations of trials over safety and ethical concern. In India, isolation of embryonic stem cells for clinical research purpose is banned. In Japan, the guidelines for 'Derivation and Utilization of Human Embryonic Stem Cells, 2001', permits the embryonic stem cells to be isolated only from spare IVF embryos, and are younger than 14 days donated with informed consent without any financial compensation beyond necessary cost. "Such regulatory affairs may act as hurdles for companies requiring stem cell isolation for developing their products," pointed M&M's analyst. Competing with Goliaths The cell isolation market is marked by high competition. There are various big firms with strong financial strength, as well as several smaller organizations with similar product offerings. This market is dominated by Thermo Fisher Scientific (TFS) (US), Becton Dickinson (BD) (US), Beckman Coulter (US) and Miltenyi Biotec (Germany) which together constituted more than 85 percent of the market share in 2013. TFS leads the cell isolation products market. In February 2013, it acquired Life Technologies. Life Technologies was the leading supplier of magnetic beads (Dynabeads), an expensive and high-growth opportunity cell isolation product. This acquisition helped the company to become a leader in the cell isolation market by adding various cell isolation products in its portfolio. The acquisition also added magnetic beads, centrifuges, flow cytometers, various cell isolation reagents, enzymes, and media to TFS's product portfolio. BD is the second-largest player in the cell isolation market followed by Beckman Coulter, and Miltenyi Biotec respectively. Key Players:  Beckman Coulter Becton Dickinson (BD) Biosafe GE Healthcare Merck Millipore Miltenyi Biotec pluriSelect STEMCELL Technologies Terumo BCT Thermo Fisher Scientific (Life Technologies) ]]> https://biospectrumindia.com/features/97/6278/west-pharma-bets-big-on-crystal-zenith.html https://biospectrumindia.com/features/97/6278/west-pharma-bets-big-on-crystal-zenith.html Sat, 16 May 2015 08:59:00 +0530 In April, West Pharmaceuticals, a manufacturer of drug administration systems and components, held several seminars across Indian cities to discuss its exclusive product -- Daikyo Crystal Zenith (CZ), which it claims will be the new life cycle solution for drug containment in the pharma industry, seen as an alternative to traditional glass. Crystal Zenith components are made of Cyclic Olefin Polymer (CoP) material, which is said to be more inert than glass. West said that this new containment solution will address issues of breakage, protein aggregation, delamination, and reactions with tungsten or silica, usually associated with glass. R&D impact Glass recalls were maximum in 2011, followed by 2014. Glass recalls have maximum impact on R&D plans affecting companies' competitive advantage. Consequently, the company experiences major revenue loss, impacting patient-access thereby promoting negative corporate image.   West claims that the world's 35 biologics are packaged and delivered with components manufactured by West, and its Japanese partner, Daikyo Seiko. Their partnership has been in existence since 1970. According to the company, the CZ product is manufactured at West's US plant in Scottsdale, Arizona, and Daikyo's plant in Japan. Currently, CZ is unavailable in India. "We are working with customers to get into stability trials and test the product. We see Indian market to be lucrative and rapidly growing in the APAC for this product. Now we are on a level of talking to customers about the alternatives to glass and its benefits," said Mr Kevin D Cancelliere, director of marketing, pharmaceutical delivery systems, West Pharmaceuticals. Targeting expensive drugs Mr Cancelliere said that the company at the moment is targeting expensive drug products that are still in the pipeline. The CZ's target markets include Australia, China, India, Japan, Singapore, and Taiwan. Initially the company seeks to get a handful of customers to start the initial phase of evaluation. "So far, 6 to 8 customers have expressed interest in the product," he revealed. "This product may take at least two more years for its launch," Mr Cancelliere added. Pricing Mr Cancelliere sees a major challenge for CZ in the Indian market - pricing. "The price is going to be a challenge. We are selling products of higher costs but it is a premium offering. The features outweigh the costs. This product is exclusive, and there are no other similar products. It is silicone-free and a first-in-class new polymer," he opined. "In terms of product volume, we want to produce about 2-3 million of it annually," he further said He also hinted that West Pharma will possibly have new acquisitions in the future which would further add to its capabilities. The market West's main line of business include pharmaceutical packaging systems, and pharmaceutical delivery systems, which recorded revenues touching $1 billion and $402 million in 2014 respectively. Globally, sales of self-injection devices touched $181 billion in 2014. Out of which, 44 percent was for self-administration devices ($80 billion) and 56 percent for physician-administered devices ($101 billion). Experts believe that increased regulatory scrutiny, and higher focus on quality risk management calls for containment materials which do not interfere with the drug or hamper its effectiveness. Patent expirations He pointed that the number of biologics are reaching their patent life. "We see tremendous growth in the area of biosimilars. Biosimilars are going to explode, and CZ is going to be a game changer. We are going to have generics come out and have lower cost alternative. Some of the existing biosimilars where glass is used have packaging issues, and CZ will address that," he held. Speaking about the market share, Mr Cancelliere commented, "We have certain projections, and for injectables, globally, we hope to capture 5 percent market share by 2019. A small portion of this will come from APAC, which could be less than a percent." ]]> https://biospectrumindia.com/news/97/6367/theorem-opens-a-new-clinical-supplies-facility-.html https://biospectrumindia.com/news/97/6367/theorem-opens-a-new-clinical-supplies-facility-.html Fri, 15 May 2015 16:10:27 +0530 Theorem Clinical Research will open a new, state-of-the-art clinical supplies facility in Frankfurt, Germany, in June. The current good manufacturing practice (cGMP) compliant facility will triple Theorem's current clinical supplies capacity, with space for 2,700 square meters of ambient (15 to 25°C) and refrigerated (2 to 8°C) space. The opening also positions Theorem's clinical supplies hub near the Frankfurt Airport, a major transportation hub. "We are excited to have the additional manufacturing and warehousing space and, more importantly, an infrastructure to deliver the flexibility our clients rely on," said Mr John Potthoff, president and CEO, Theorem. He added, "The new facility will enhance speed and scalability while preserving the versatility of our supply solutions." The launch of the new facility will strengthen current practices such as its 24/7/365 storage, continuous monitoring and backup and provides space for future service expansion.   ]]> https://biospectrumindia.com/news/97/6488/danaher-to-acquire-pall-corp-for-13-8-bn.html https://biospectrumindia.com/news/97/6488/danaher-to-acquire-pall-corp-for-13-8-bn.html Thu, 14 May 2015 12:01:42 +0530 Danaher Corp announced that it has entered into a definitive merger agreement with Pall Corporation pursuant to which Danaher will acquire all of the outstanding shares of Pall for $127.20 per share in cash, or a total enterprise value of approximately $13.8 billion, including assumed debt and net of acquired cash. The acquisition has been unanimously approved by the board of directors of each company, and the Pall board of directors has unanimously recommended that Pall shareholders approve the transaction. The transaction is expected to be completed around the end of calendar year 2015. Pall is a leading global provider of filtration, separation and purification solutions that remove contaminants or separate substances from a variety of solids, liquids and gases. Decades of work by Pall's filtration engineers and scientists have built a highly-respected brand on which customers rely to solve their most difficult purification problems across the broad spectrum of life sciences and industry.   In its fiscal year ended July 2014, Pall generated consolidated revenues of US $2.8 billion, with US $1.5 billion from its Life Sciences segment and US $1.3 billion from its Industrial segment. The Life Sciences segment serves customers in the fast-growing biopharmaceutical market, as well as food & beverage and medical end markets. Danaher's president and CEO, Mr Thomas P Joyce, Jr., said, "Pall is a highly attractive business, with approximately 75 percent recurring revenues, mid-single digit organic growth and a solid margin profile. Its best-in-class technology, combined with the broadest, most technically-advanced solutions, make it the premier brand in the filtration industry." He further added, "Pall will provide us a leading business with significant runway for expansion and strengthens our life sciences position in the strategically-attractive, high-growth biopharmaceutical market. With the Danaher Business System as a foundation, Pall associates will have the tools to accelerate new product development and improve operational efficiency in the years to come. We look forward to welcoming the Pall team to Danaher." The merger is subject to customary conditions, including approval by Pall's shareholders, receipt of applicable regulatory approvals and the absence of a material adverse effect on Pall. Danaher estimates the Pall acquisition will be approximately US $0.40 accretive to non-GAAP, adjusted diluted net earnings per share in 2016, excluding non-cash amortization, purchase accounting and transaction expenses. ]]> https://biospectrumindia.com/news/97/6371/fujifilm-completes-the-acquisition-of-teramedica.html https://biospectrumindia.com/news/97/6371/fujifilm-completes-the-acquisition-of-teramedica.html Thu, 14 May 2015 11:51:35 +0530 FUJIFILM Medical Systems has announced the completion of its acquisition of TeraMedica, a global healthcare informatics company and a leading provider of vendor neutral enterprise solutions. "As a leader in clinical archiving, TeraMedica is at the forefront of the Vendor Neutral Archive market. It is a company with talented people and unique technology that will strengthen our position in healthcare informatics. Together, we will be able to deliver medical informatics solutions that acquire, analyze, interpret and present patient data in ways that are meaningful for providers in the most challenging environments," said Mr Jim Morgan, vice-president of Medical Informatics, FUJIFILM Medical Systems. TeraMedica has recently received the "VNA/Image Archive KLAS Category Leader" award for 2014 as part of the Best in KLAS Report. The company enables cross-departmental image content sharing of patient data from disparate healthcare IT applications, while always maintaining the integrity of the original data stored while also embracing the latest centralized archiving technologies. "The VNA market is expected to see significant growth in the coming years, and now with the combined strength of FUJIFILM Medical Systems, we have the ability to meet this demand. This transaction will bring together the complementary strengths of Fujifilm's best-in-class software and services with TeraMedica's pioneering VNA, maximizing our operational efficiencies," said Mr Jim Prekop, president and CEO, FUJIFILM TeraMedica.   ]]> https://biospectrumindia.com/news/97/6606/pall-inc-to-be-acquired.html https://biospectrumindia.com/news/97/6606/pall-inc-to-be-acquired.html Wed, 13 May 2015 14:20:19 +0530 According to latest reports from Wall Street and Dow Jones, Pall Corporation, a leading manufacturer of filtration technologies, is said to be up for auction worth US $10 billion. More developments are expected to unfold later this week as talks about the possible takeover progresses. ]]> https://biospectrumindia.com/news/97/6270/harvard-cardiologist-joins-google-x.html https://biospectrumindia.com/news/97/6270/harvard-cardiologist-joins-google-x.html Wed, 13 May 2015 12:45:52 +0530 Google X, the technology giant Google's research arm has appointed Dr Jessica Mega to head its Baseline Study, as per reports. Dr Mega is associated with the Harvard Medical School and Brigham & Women's Hospital. Baseline is one of the important projects undertaken by the lifesciences division of Google X. The project, announced last year, "is designed to understand what it means to be healthy, down to the molecular and cellular level," according to a Google press statement. In its first small pilot phase, the study is collecting genetic and molecular information on 175 people. The researchers aim to employ powerful software algorithms and large amounts of computing power to query enormous and complex data sets to find connections. Google X has teamed up with researchers at Stanford and Duke universities to design and conduct a larger study which will enroll thousands of patients and involve an unprecedented quantity of data. According to Google X, "The study is intended as a contribution to science; it's not intended to generate a new product at Google. It may unlock lots of ideas for future projects, not just at Google but across the health and technology industries."   ]]> https://biospectrumindia.com/features/97/6540/india-coronary-stent-market-to-triple-by-2021.html https://biospectrumindia.com/features/97/6540/india-coronary-stent-market-to-triple-by-2021.html Tue, 12 May 2015 14:00:30 +0530 DES accounts for bulk of sales in India. The bio-absorbable stent ABSORB has garnered a considerable traction despite its high cost compared with the other available DES. The market has grown impressively supported by a rise in coronary angioplasties which has resulted from a surge in cardiovascular diseases (CVDs), augmented healthcare spending as well as an increase in number of interventional cardiologists and cath labs in government and private hospitals, including individual cath lab centres run by interventional cardiologists as well as new corporate hospitals. The demand has surged as central and state governments capped reimbursement rates which enhanced affordability resulting in an increase in volume. The decrease in reimbursement rates has given an edge to Indian, Asian and some of the Europe-based mid-sized MNCs which sell stents at almost half the price of those sold by US companies. "In the US, the stents market has slumped significantly due to negative results from clinical studies suggesting that one-third of stent implants are unnecessary. However, in India these studies have not made an impact as most Indian cardiologists do not seem to have taken these clinical outcomes seriously," said Mr Manoj Jiandani, CEO, Ace Business and Market Research Group (ABMRG), a medtech market intelligence company. The key players operating in the segment are Alvimedica, Abbott Vascular, a division of Abbott Laboratories; Boston Scientific; Biosensors; Biotronik; JW Medical; Medtronic; Meril Life Sciences; MicroPort Scientific Corporation; Sahajanand Medical Technologies; and Translumina Therapeutics. ]]> https://biospectrumindia.com/news/97/6615/toshiba-upgrades-its-aquilion-one-ct-systems.html https://biospectrumindia.com/news/97/6615/toshiba-upgrades-its-aquilion-one-ct-systems.html Tue, 12 May 2015 11:56:16 +0530 Toshiba America Medical Systems' new detector and CT software enhancements for its Aquilion ONE Family of CT systems have received the United States Food and Drug Administration (US FDA) clearance. Toshiba offers an extensive portfolio of software and hardware enhancements that extend the life of imaging systems with the most advanced technology available like PUREViSION CT Detecto, the new and efficient CT detector, which delivers results in 40 percent better light output for better use of X-ray photons; SUREkV which provides automated kV selection, based on patient size; Organ Effective Modulation that delivers safer exams for both patients and providers by limiting the dose to radiosensitive organs and during helical scanning and CT fluoroscopy procedures; Contrast Management which improves workflow and safety by standardizing contrast protocols and automatically tracking the volume of contrast used during an exam. "We understand that quality measures are directly linked to patient safety and satisfaction, and at Toshiba, we continue to develop technology that helps our customers meet their goals," said Mr Satrajit Misra, senior director, CT Business Unit, Toshiba. He added, "Toshiba offers a fully comprehensive and responsive safety program with 360 degrees of coverage, guidance and expertise that go beyond radiation dose and extend to other areas of patient and staff safety."   ]]> https://biospectrumindia.com/news/97/5905/agilent-to-acquire-cartagenia.html https://biospectrumindia.com/news/97/5905/agilent-to-acquire-cartagenia.html Tue, 12 May 2015 10:32:11 +0530 Agilent Technologies and Cartagenia has announced that they have signed a definitive agreement under which Agilent will acquire Cartagenia, a leading provider of software and services for clinical genetics and molecular pathology labs. Uniquely geared to routine clinical labs, Cartagenia's solutions are FDA-registered as exempt Class I Medical Devices in the U.S. and as Class I Medical Devices in Europe. The Cartagenia Bench platform enables technicians, lab directors and clinicians to visualize, assess and report clinical genetics data in the context of patient information. With Cartagenia Bench, labs can build an internal knowledge base, build variant assessment SOPs, automate report drafting, and access a wide range of community-validated, private and premium content resources, whether for oncology or inherited disease. Cartagenia's platform also provides deep support for consortia of collaborating labs. "Cartagenia's approach to enabling the interpretation of clinical genomics data is revolutionary. We look forward to providing Cartagenia's software solutions to our clinical genetics and molecular oncology customers and to providing Cartagenia's existing customers with access to our global service and support network. Together, Agilent and Cartagenia can help remove bottlenecks inherent in analysis, interpretation and reporting clinical data-resulting in faster answers for patients," said Mr Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "Joining forces with Agilent is an excellent strategic fit and provides tremendous opportunity both for our customers-who will benefit from integration with a broad family of solutions and a range of new applications-and for our team, as we'll be able to further accelerate our success and growth through Agilent's global reach and leading footprint in clinical labs," said Mr Herman Verrelst, chief executive officer, Cartagenia.   The acquisition is expected to be completed by May 19, subject to local laws and regulations and customary closing conditions. Cartagenia employs 36 people, all of whom will be offered employment with Agilent. Financial terms of the transaction were not disclosed.   ]]> https://biospectrumindia.com/news/97/5578/s10-health-launches-safecare-in-chennai.html https://biospectrumindia.com/news/97/5578/s10-health-launches-safecare-in-chennai.html Mon, 11 May 2015 15:22:14 +0530 S10 indicates that SafeCare sets into place quality standards and benchmarks for clinics to adhere to, as well as combines patient convenience and ease of access to world-class affordable healthcare.S10's SafeCare experience is delivered both from its mobile app, S10 Health available both on iOS and Google play platforms and also a web interface. Currently, SafeCare connects 15 locations with speciality care in dental, eye, cosmetic, maternity, sports medicine, orthopaedics, internal medicine, and diabetic specialization across Chennai. The company plans to launch the product in phases across India in the next few years.Mr Sridharan Sivan, founder and CEO, S10 Health said, "As India's first independent SafeCare network, S10 Health is committed to empowering the Indian population with access to the best healthcare experience. We are proud to run the first specialty care outpatient quality control standards check in India which enables clinics to be part of the SafeCare network. In the last year, SafeCare has partnered with 15 clinics and grown its base to 145,000 subscribers with 93 percent satisfaction levels. The app serves as the perfect healthcare assistant, thus providing a personalized and convenient way to monitor health at every stage. Not only does SafeCare help with scheduling appointments with the best physicians, but health seekers can also access their medical records online, which is stored on the cloud."Dr Afser Shariff, co-founder and chief medical officer said, "Recent figures indicate that 20 percent of global disease burden exists in India, which creates a need for a superior patient experience. Globally present in both the US and India, S10 Health mobilizes SafeCare for consumers by partnering with physicians through optimal use of technology. Besides the benefit to consumers, speciality and primary care centres will provide optimal care that has been customized to them."Dr Arulmozhi Varman said, "I am pleased to be associated with SafeCare as I strongly believe that this approach is going to be crucial in transforming the healthcare industry in India. It will provide a smooth patient appointments booking and management process and platform. More importantly, S10 Health app will provide access to the right kind of doctor depending on the patient's ailments and requirements." ]]> https://biospectrumindia.com/features/97/7363/clean-ganga-mission-using-new-technologies.html https://biospectrumindia.com/features/97/7363/clean-ganga-mission-using-new-technologies.html Sat, 09 May 2015 08:50:00 +0530 Prime Minister Mr Narendra Modi launched an Integrated Ganga Conservation Mission called "Namami Gange" last year. The mission approaches Ganga Rejuvenation by consolidating existing ongoing efforts and planning for a concrete action plan for the future.A Consortium of seven Indian Institutes of Technology (IITs) has prepared a Ganga River Basin: Environment Management Plan. Reports suggest that Industries directly or indirectly discharging their solid/liquid wastes into RÄ?mgangÄ?, Kali and Ganga must be directed to follow best available practices for managing solid/liquid wastes and attain complete recycling of water and proper disposal of solid wastes/sludge as per norms enforced by regulating agencies. Also, IIT Kanpur has prepared a compendium to provide an overview of different technological options available for treatment of sewage and assessment of their performance. This compendium of sewage treatment technologies have been prepared based on primary and secondary data gathered from operations of sewage treatment plans in the country over the last two decades.According to reports, Union Minister for Water Resources Ms Uma Bharati has said that expertise from premier IITs would be utilized for cleaning the river Ganga, which would be completed in the shortest period."We will be using various technologies for rejuvenation of river Ganga. We will be utilizing the services of IIT experts and explore all possible options," she said on the sidelines of Ganga Manthan.The PM's pet project is also receiving support from foreign shores, the German Government has offered Rs 3 million euros for supporting Ganga Rejuvenation during the Indo-German Government Negotiations held in November 2014. Many countries such as Germany, Australia, Canada, Singapore, and Netherlands have expressed interest in supporting Ganga Rejuvenation through knowledge/technology sharing and providing financial/technical assistance for cleaning up Ganga, capacity building, research and development, sharing of experiences, expertise, and best practices. The National Mission for Cleaning Ganga is in continuous dialogue with relevant organizations of these countries to facilitate a fruitful involvement of foreign countries in Ganga Rejuvenation. Also, Israel has expressed interest in sharing its expertise on water purification and waste water treatment for cleaning the Ganga. Government policy has given a boost for harvesting solar energy. The support to renewable sources, biogas or biofuel need sustained support for research as well as field level dissemination."Harvesting renewable sources (solar, biomass, biogas) and youth power will make our country a developed country. To realize this vision, there has to be a paradigm shift in energy planning with focus on renewable sources of energy," summed up Dr TV Ramachandra, professor, Coordinator of Energy and Wetlands Research Group (EWRG), Convener of Environmental Information System (ENVIS) at the Center for Ecological Sciences (CES), IISc.   ]]> https://biospectrumindia.com/news/97/5661/coming-soon-dna-testing-through-iphone-.html https://biospectrumindia.com/news/97/5661/coming-soon-dna-testing-through-iphone-.html Fri, 08 May 2015 12:19:15 +0530 According to a report in MIT Technology Review, Apple is collaborating with researchers in the US to launch apps that would offer iPhone users the chance to get their DNA tested. Reportdely, the apps are based on ResearchKit, a software platform that the tech giant  introduced earlier. The platform helps hospitals or scientists run medical studies on iPhones by collecting data from the devices' sensors or through surveys. The first five ResearchKit apps, including one called mPower that tracks symptoms of Parkinson's disease, quickly recruited thousands of participants in a few days, demonstrating the reach of Apple's platform. In two initial studies planned, Apple is not going to directly collect or test DNA itself. That will be done by academic partners. The data would be maintained by scientists in a computing cloud, but certain findings could appear directly on consumers' iPhones as well, the report stated. The University of California at San Francisco and Mount Sinai Hospital in New York are working on the first two DNA testing apps, as per the report.  ]]> https://biospectrumindia.com/features/97/8059/indias-tryst-with-green-technologies.html https://biospectrumindia.com/features/97/8059/indias-tryst-with-green-technologies.html Fri, 08 May 2015 11:30:00 +0530 India ranks ninth overall on Ernst and Young LLP's most recent renewables attractiveness Index. Though solar energy has received much attention from the government, here's a look at how the nation has fared in other renewable energies important for environment sustainability. BioFuelThe National Biofuel Policy initiated in 2009 aimed at mainstreaming biofuels and therefore, envisions a central role for it in the energy and transportation sectors of the country."The policy has outlined procedures for next generation fuels from agricultural residue. But the technological advancements have not there been yet. Other future generation fuels such as fuels from microalgae and macro algae (seaweed) have been mentioned but there has been no road-map on how to realize the huge potential of such fuel," said Dr Dheeban Chakravarthi Kannan, fellow, The Energy and Resources Institute (TERI).The goal of the policy is to ensure that a minimum level of biofuels become readily available in the market to meet the demand at any given time."India's target is to have 5 percent biofuel blending in with transportation fuels by now. We are hovering around 0.2-0.4 percent. Basically this is nothing. India has not been able to produce any appreciable quantities of biofuels. This is critical as it relates to substituting the product that makes the biggest pinch on the foreign import bill. The current annual crude oil import bill is about Rs 6,000 billion per year (amounts to 34 percent of the total import bill, by far the biggest share). Yet, we have made no stride in addressing such an important issue," said Dr Kannan. He added, "Bioethanol from sugarcane molasses has got such a low minimum supporting price that the ethanol produced is first diverted towards potable and chemical industry. Only the left over finds its way into the fuel market. As a result the availability has fluctuated from zero to 0.4 million tons/year in the past decade. The situation of biodiesel is even worse, with reported production levels of zero to 0.1 million tons/year and is mostly utilized in unorganized sectors such as farm vehicles. Compare this to our present annual transportation fuel demand of 92 million tons/year and this is projected to increase to 200-250 million tons/year by 2030."The government has been supporting these technologies through its funding agencies such as Ministry of New and Renewable Energy and Department of Biotechnology. Dr Kannan further elaborated, "The government also has provisions for private-public partnership funding. But the funding, in general, has been low. More funds could be allocated for active and extensive research in this area that has critical implications on our national economy and environment." BiogasUnder the National Biogas and Manure Management Program (NBMMP), the government has managed to install about 50 lakh biogas plants in rural and semi-urban areas across the country.However, reports from various studies, including an official government report on the success of the NBMMP mission show that over 50 percent of these plants have fallen to disuse. "Despite a well-intentioned attempt to meet the free energy needs of the rural poor, the biogas program has not really met the cooking needs. Today, biogas cooking fuel contributes to less than 1 percent of the total cooking fuel requirement in the country," said Ms Pooja Vijay Ramamurthi, research engineer, cSTEP. The main challenges have been a lack of incentives to keep the plants running, and lack of operation and maintenance know-how. Mr Suresh NS, senior research engineer, cSTEP further added, "Therefore, we see that there are issues like generation incentives for the plants to be well maintained vs the government, which provides a capital subsidy for the plants and unfortunately does not have a mechanism to ensure the smooth running of the same."The government could learn from the projects like the Bagepalli plants in Karnataka which have shown tremendous success. Initiated in 2005, this project is NGO run and is still running. They have managed to provide 5,500 households in the Kolar district of Karnataka with clean fuel for cooking. The key to their success has been community engagement and a strict monitoring scheme. Community members from a local council, some of whom are trained in project maintenance, and others monitor the status of the plants. If these plants are running smoothly, then the family members are exempted from paying part of the cost of the biogas plant.A few potential ways in which biogas plants can be made more effective include increased local community participation, monitoring of plants, and provision of generation incentives. "As such there are no schemes or guidelines that can influence neither common man nor corporate bodies to include biogas as an integral part of their system. There is also no visibility for such kind of products and projects from governmental bodies," said Mr Zeeshan, Synod Biosciences, a biogas plant manufacturing company. Solar biomassThe development of a solar-biomass hybrid combination is at a nascent stage in the country. "In the past, MNRE has created a few solar-biomass demonstration projects: 15 kW capacity with Thermax and TERI for process cooling and 700 kW peak capacity with Megawatt Solutions for process heating. Presently, the Center for Study of Science Technology and Policy (CSTEP) is setting-up a 3 MW solar-biomass hybrid power plant in Bihar in collaboration with Thermax and European partners," informed Mr Narasimhan SV, advisor, cSTEP.Solar-biomass hybrids are a very good option to provide electricity to communities without electricity access. Organizations like Husk power Systems and Decentralized Energy Systems (DESI) are looking towards this technology. DESI has said that they have installed a solar PV- biomass system where they use the PV system (with storage) to satisfy lighting needs and use the biomass plant to satisfy larger industrial needs (like a rice mill, wheat mill or ice making factory). However, these hybrids haven't found widespread market acceptance. "There are about 1000 MW of grid-connected biomass plants installed in the country, however the Indian Biomass Power Association (IBPA) states that over 60 percent of them are on their way to be shut down. This is mainly due to unrevised (low) tariffs and feedstock constraints," said Ms Ramamurthi.With solar and wind getting all the spotlight, the biomass sector has been relegated to the background. However, in order to provide effective energy supply to the country, biomass resources are extremely crucial. There need to be more proactive steps to promote biomass electricity plants. As large plants find it difficult to get feedstock (5-20 MW), smaller plants need to be encouraged (up to 1 MW). These plants can be used to take care of local rural electricity needs, tied up to telecom towers, or provide irrigation pumping services. As feedstock is an issue, hybrids should be encouraged, with wind and solar. Biomass can be used to complement the variable nature of these resources. Biomass plantations can be encouraged, where certain species are grown exclusively to use as fuel. An important first step would be to conduct a more detailed national assessment before utilizing these lands for biomass. The survey will ideally capture residue availability and identify suitable wastelands for plantations of different species. The possibility of briquetting agro-residues should also be explored. The only assessment made on a nation-wide scale by IISc, is a decade old and doesn't explore plantation potential.A stance similar to the Karnataka Solar Policy 2014 can be adopted, where farmers lease out waste/barren lands to solar companies. Farmers can lease their unutilized barren lands to private companies, who can set up captive feedstock plantations for small-scale biomass plants on a long-term basis.The long disbursal times of capital subsidies make investors not keen to solely rely on them. Hence, incentives which reward generation should be introduced. Models involving rural entrepreneurs, Electricity Supply Companies (ESCOMs), community ownership and collaboration amongst these stakeholders should be promoted. Depending on the model, appropriate soft loans can be granted. Biomass electricity plants are eligible for 80 percent Accelerated Depreciation (AD) in the first year. However, AD benefits for biomass plants aren't effective because biomass electricity producers tend to be small ventures, which don't have large profits. To ensure a level playing field, schemes where AD benefits can be traded should be introduced.Clean Technologies for Clean India MissionHere's how the embracing of these technologies would help in the Clean India Mission If the energy demand is met by renewables, the need for fossil fuels will reduce. Thus, there will be a reduction of emissions to the atmosphere, leading to a sustainable environment. The Indian Institute of Tropical Meteorology's recent report shows that open burning of biomass residues causes significant pollution in India. Using these agricultural residues for electricity generation could lower 25-50 percent of the total CO and NO2 emissions in the country. Cooking in rural India is done by fuel wood in 90 percent of the houses. This is a very polluting resource that causes indoor air pollution, leading to the release of particulate matter and harmful gases. Therefore, replacing this with clean cooking fuel such as biogas will be environmentally sustainable, while at the same time save many lives that are exposed to the harmful effluents. Fuel wood consumption also leads to deforestation which biogas can prevent. A biogas unit is helpful in controlling the release of methane gas into the atmosphere which is the 2nd direct contributor to global warming after carbon dioxide. Incorporating a proper defecation system at the household or community level and its use to generate biogas along with other bio-wastes will play a significant role in the success of the Clean India Mission. A key factor of the Clean Indian Mission is to dispose of waste in a hygienic way. Hence, biomass waste can be used in gasifiers, combustion plants and biogas plants. These are renewable fuels; hence they have a significant role to play in cutting carbon emissions. Next generation biofuels such as lignocellulosic liquid fuels (from non-fodder agri-residue) and algal biofuels have large enough scope (20-50 percent) to substitute a significant proportion of fossil fuels.   ]]> https://biospectrumindia.com/news/97/4588/quest-diagnostics-launches-new-test-for-hematologic-malignancies.html https://biospectrumindia.com/news/97/4588/quest-diagnostics-launches-new-test-for-hematologic-malignancies.html Fri, 08 May 2015 10:56:14 +0530 Quest Diagnostics has announced the launch of LeukoVantage, an evidence-based genomic test service that aids in the diagnosis, prognosis, monitoring, and selection of treatment for myeloid neoplasms, a group of hematologic malignancies that includes acute myeloid leukemia (AML). AML is the most common form of adult acute leukemia, as well as myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPNs). "LeukoVantage is an outgrowth of Quest's commitment to advancing oncology care based on actionable molecular insights. There is growing evidence that several genetic alterations involved in myeloid neoplasms not only provide significant diagnostic and prognostic value, but may also help guide treatment decisions. LeukoVantage builds from the latest science and Quest's deep experience in genomics and hematology to deliver insights that can help the physician potentially diagnose the patient more quickly and reliably and establish an appropriate treatment plan," said Dr Frederick K Racke, medical director, hematology oncology, Quest Diagnostics. LeukoVantage is a lab-developed test that uses next-generation sequencing, polymerase chain reaction (PCR) and other techniques to study DNA from leukocytes (white blood cells) in blood or bone marrow specimens for the presence of mutations in 30 genes most frequently associated with myeloid neoplasms. For MDS, LeukoVantage may detect certain molecular markers to help identify early stages of the disease, complementing conventional diagnostic techniques. MDS is typically diagnosed through a series of tests that include complete blood count (CBC), morphology, and cytogenetic (chromosomal) analysis. For MPN, LeukoVantage may identify molecular markers that can aid the selection of certain targeted therapies, such as JAK2 inhibitors, and establishing a prognosis. LeukoVantage has also been shown to detect gene mutations in greater than 95 percent of newly diagnosed cases of AML. Physicians may use this information to aid in disease diagnosis and subclassification as well as to establish a treatment plan with induction chemotherapy. In addition, LeukoVantage may aid in establishing a prognosis and in monitoring for minimal residual disease and recurring disease. In the case of both AML and MDS, LeukoVantage may also provide information for selecting epigenetic modifying drugs, which may be less toxic than inpatient chemotherapies.   In addition to LeukoVantage, Quest Diagnostics provides an industry-leading menu of hematologic test services, including morphology, flow cytometry, cytogenetics, FISH, and molecular services for blood and bone marrow specimens and other tissues and body fluids as necessary. Because patients with hematological cancers often require multiple services, clinicians may prefer a single provider that can coordinate, perform and interpret all necessary testing services as well as split bone, blood and other samples to simplify test ordering and reporting. "LeukoVantage is an innovative and clinically useful lab test but that is only part of its value. Quest Diagnostics provides a broad suite of accompanying services for diagnosing and managing patients with myeloid neoplasms. Those larger capabilities can be most useful for these and other diseases in which continuous monitoring, supported by lab tests, is vital to promote quality patient care," said Dr Frederic Waldman, medical director, cancer diagnostics, Quest Diagnostics.     ]]> https://biospectrumindia.com/news/97/4591/us-fda-nod-for-opto-circuits-aed.html https://biospectrumindia.com/news/97/4591/us-fda-nod-for-opto-circuits-aed.html Fri, 08 May 2015 10:47:59 +0530 Cardiac Science Corporation, a group company of Opto Circuits (India) has announced that its Powerheart G5 AED with CRPD has received 510(k) market clearance from the US FDA (United Sates Food and Drug Administration), allowing the company to begin selling the AED with CPRD along with its successful Powerheart G3 and G5 product line. "This news is a testament to the commitment shown by our employees who have spent many years of developing, testing and refining the Powerheart G5 so that seasoned and first-time rescuers will have the most reliable, easy-to-use AED in the US marketplace. Our product portfolio is now the envy of the AED industry," said Mr Vinod Ramnani, chairman and managing director, Opto Circuits (India). The Powerheart family of AEDs is designed to enable rescuers to swiftly provide effective, life-saving therapy to aid a person who has suffered sudden cardiac arrest (SCA). The American Heart Association notes that at least 20,000 lives could be saved annually by prompt use of AEDs. Ultimately, with the broad deployment of AEDs among trained responders, as many as 50,000 deaths due to SCA could be prevented each year, a cause Cardiac Science is firmly behind. Cardiac Science has been working to reduce SCA fatalities since it introduced the first fully automated external defibrillator.   The Powerheart G5 with CPRD will be available for purchase in the United States later this year.   ]]> https://biospectrumindia.com/news/97/6952/ppd-recognized-for-excellence-in-clinical-research.html https://biospectrumindia.com/news/97/6952/ppd-recognized-for-excellence-in-clinical-research.html Fri, 08 May 2015 08:40:00 +0530 Pharmaceutical Product Development, LLC (PPD) has announced that it has been recognized for excellence in clinical research by pharmaceutical and biotechnology company executives surveyed for Life Science Leader magazine's 2015 CRO Leadership Awards. PPD earned honors for high quality and reliability, based on survey responses from more than 2,300 industry executives responsible for making or influencing decisions to outsource clinical development programs to contract research organizations (CROs). The company spans the value chain of clinical research with integrated Phase I-IV services and PPD Laboratories, which offers the most comprehensive lab services available in the industry, from pharmaceutical discovery through late stage research. "These awards recognize our talented professionals who are dedicated to providing innovative services that our clients can count on in their efforts to deliver life-changing therapies to patients more quickly and cost-effectively. We share our clients' passion for advancing medical research, and we are committed to collaboration, operational excellence and high-quality service delivery," said Mr Jay Dixon, senior vice-president for global quality and compliance at PPD. The Life Science Leader CRO Leadership Awards are based on surveys and industry research conducted by Nice Insight, the market research division of That's Nice LLC, to help the publication's subscribers assess CROs.   ]]> https://biospectrumindia.com/news/97/4352/canon-life-sciences-appoints-a-new-president-.html https://biospectrumindia.com/news/97/4352/canon-life-sciences-appoints-a-new-president-.html Fri, 08 May 2015 08:39:00 +0530 Canon USA has announced the appointment of Ms Akiko Tanaka as president and CEO of Canon US Life Sciences (CLS), a wholly owned subsidiary of Canon USA.  Ms Tanaka, previously the vice-president and COO of CLS, has also been appointed to the CLS Board of Directors. In this position, Ms Tanaka will oversee the management of business initiatives relating to the development of diagnostic solutions. Dr Ivor Knight, senior vice-president and CTO, will report directly to Ms Tanaka to support these initiatives. Ms Tanaka has also been recently appointed as the president and CEO of the newly established Canon BioMedical (CBMI) which focuses on the development, manufacturing, and marketing operations relating to lifescience and molecular diagnostics businesses. This new company will look for long-term future growth opportunities in previously untapped markets for Canon such as lifescience, healthcare, and medical analysis through the use of existing and emerging Canon technology, as well as strategic partnerships. "I am confident that under the leadership of Ms Tanaka, Canon will succeed in its mission to develop innovative technologies and solutions that assist in improving human health and in advancing science," said Mr Joe Adachi, chairman and CEO, Canon USA. "I am honored to take on this new role and to help align the overall biomedical strategy in the Canon Americas. Both CLS and CBMI will work together to research, develop and bring new technologies to markets all over the world," said Ms Tanaka.   Ms Tanaka has spent 29 years working for Canon and joined Canon USA in April 2012. She began her career at Canon Inc. in 1986 as a system engineer doing software development in R&D and later joined a Strategic Alliance that handled all of Canon's OEM business.     ]]> https://biospectrumindia.com/news/97/8210/taiwans-apex-medical-forays-into-indian-market.html https://biospectrumindia.com/news/97/8210/taiwans-apex-medical-forays-into-indian-market.html Thu, 07 May 2015 13:40:03 +0530 Apex Medical Corporation, a $75 million company and a major player in the respiratory therapy and pressure area care sectors, has made its debut into Indian market with the launch of its three main product verticals - respiratory, support surface and autoclaves primarily as their core offering in India. The company has a long term plan for the Indian market and will proceed in phases in a strategic manner, Apex said. In the next few years, with an aggressive growth plan, Apex in India expects to grow at a CAGR of 30 percent. Founded in the year 1990, Apex Medical is headquartered in Taiwan, the company caters to Europe, United States, Asia and other international markets through an established network of international subsidiaries and partners. Apex invests 5 percent of its annual revenue into R&D.   Speaking at the occasion, Mr Daniel Lee, CEO, Apex Medical, said, "...We look forward to be part of this continuously growing healthcare industry in India. As the Indian market is growing at 7-8 percent with healthcare market growing at 12-15 percent, we expect Apex in India to grow at least by 5 times in the next five years...." Mr Puneet Sahai is the current president of Apex Medical India. ]]> https://biospectrumindia.com/features/97/4247/biotechnological-separation-systems-to-touch-28-bn.html https://biospectrumindia.com/features/97/4247/biotechnological-separation-systems-to-touch-28-bn.html Thu, 07 May 2015 10:03:23 +0530 Macromolecules which include protein, RNA, DNA and nucleic acids undergo separation or are broken into smaller molecules, during production of commercially available biotechnological products. This separation requires various advanced systems like centrifugation, liquid chromatography, electrophoresis, membrane filtration and other methods for biomolecular methods. The other methods involve microarray and lab-on-a-chip, flow cytometry, magnetic separation. The separation systems have immense application in complex compound separation, production of hormones, insulin, vaccines and enzymes used as therapeutic agents against various diseases. They play important role in cell-tissue characterization and in forensic analysis as well.   The global market of biotechnological separation systems is forecasted to be around $28 billion by 2019, growing at an approximate CAGR of 10 percent in the forecasted years. The liquid chromatography market occupies a largest share of all the available techniques and membrane filtration market is the fastest growing segment. Enhancing need for improved large-scale separation and purification methods in biotechnology industry, competition in research and development field and recognition of different separation techniques are the major drivers leading to market growth in developed countries. Increasing investment in this sector contribute to market expansion in India, China and Brazil. The major industry players in separation system market are Affymetrix (US), Applied biosystems Corporation (US), Beckman Coulter Inc (US), Bio-Rad Laboratories (US), Caliper Life Sciences, Dionex, GE Healthcare Life Sciences (US), Invitrogen (US), Life Technologies, Perkin-Elmer (US), Pall Corporation (US), Qiagen GmbH (Germany), Shimadzu Scientific Instruments (Japan), and Whatman International. ]]> https://biospectrumindia.com/news/97/7808/max-neeman-acquired-by-canada-based-jss-research.html https://biospectrumindia.com/news/97/7808/max-neeman-acquired-by-canada-based-jss-research.html Thu, 07 May 2015 10:02:19 +0530 The stringent regulations and perhaps lesser approvals to clinical trials, lead to the sell off of an important Indian clinical research organization (CRO). Or the decision is purely at its higher management's discretion, based on some other reasons. Whatever be the cause, Max Neeman International has been bought over by Montreal-based CRO, JSS Medical Research. On May 04, it announced the conclusion of the acquisition with the head office in New Delhi along with other regional offices located in Ahmedabad, Bangalore, Chennai, and Mumbai. Through a US subsidiary, Max Neeman also has a regional office in North Carolina, USA whose takeover too will be a part of the deal.  BioSpectrum tried to reach Max Neeman's top management for comments on specific details but they couldn't be reached due to their travelling plans. It would be important to know the fate of the employees and the company's overall structure after the acquisition. However, the company's spokesperson confirmed the successful completion of due delligence which was a prerequisite to the deal and conclusion of the acquisition process.  The board of Max India in its earlier meeting on January 27,2015 had approved a corporate restructuring plan to vertically split the company through a demerger, into three separate listed companies. The board also approved divestment of its clinical research business for a consideration of $1.5 Million, subject to successful completion of due diligence and signing of definitive agreements. "Our collaborations with Max Neeman in recent years have enabled us to have first-hand evidence of the quality, integrity, credibility and client centric focus of this organization that is comparable to our philosophy. Under our aegis our clients will be reassured that the work that will be conducted by our colleagues will continue to be of the highest uncompromised standards that have been the basis of the success of JSS Medical Research since its foundation over 20 years ago" mentioned Mr Stella Boukas, chief operating officer of JSS Medical Research. "The Max India group has nurtured Max Neeman to become a world class CRO with strong values and deep customer relationships. As a natural owner of this business, JSS Medical Research will provide a larger network of clients and invest in Max Neeman's growth, enabling the Max India group to focus on its core businesses", said Mr Rahul Khosla, managing director, Max India, the erstwhile parent company of Max Neeman. "This expansion enables us to provide our large pharmaceutical clients with our services to their regional affiliates in India and surrounding regions. For our biotech clients the expansion will provide them with access to patients and high quality research sites that will facilitate the completion of their clinical development programs. This is an important step for JSS Medical Research in its evolution as a niche global CRO and a major achievement for the Canadian and Quebec Health Care Research Industry because it is testimony to the fact that the quality and value of the scientific work done here transcends geographic borders and limits. I am indeed proud of this accomplishment and grateful to all of my staff and partners that have supported our company," said Dr John S Sampalis, CEO of JSS Medical Research. ]]> https://biospectrumindia.com/features/97/6508/global-cell-based-assays-market-to-grow-15-bn-by-2018.html https://biospectrumindia.com/features/97/6508/global-cell-based-assays-market-to-grow-15-bn-by-2018.html Wed, 06 May 2015 15:45:33 +0530 They can be used to study mechanisms of action such as receptor binding, receptor activation, cell signaling, ligand internalization, and subcellular localization.  The cell-based assays market is segmented into reagents and assay kits, instrument, software, services. The global cell-based assays market is expected to grow approximately $15 billion by 2018 at a CAGR of 11 percent. North America reported largest market share, followed by Europe, and Asia is expected to be the fastest growing region for increasing investments in life science research, advancements in technology and drug discovery outsourcing. These cell-based assays are routinely used in drug discovery process, ADME and basic research to establish the potency and stability of a drug substance or product and are important in establishing safety and efficacy profiles for biopharmaceuticals.   Increase in investments by pharmaceutical companies in drug discovery, replacement of in vivo toxicity testing by in vitro testing methods, adoption of cell assay based on high throughput assay (HTS) screening, low cost label-free technology, accurate results, preference over animal model and emergence of new technologies such as microfluidics are some of the major drivers," said Research and Markets, a market research firm. Whereas, intellectual property rights deprived innovation which hampered market growth. Emerging areas such as advancement in stem cell culture, induced pluripotent stem cells, 3D cell based assay, single-cell assay, need of toxicity screening are opportunistic factors, while complexity of HTS assay, assay standardization and validation are threats. Major players in cell-based assay market include BD Bioscience(US), Danaher Corporation (US), DiscoverRx (US), EMD Millipore (Germany), GE Healthcare (UK), Life Technologies Corporation (US), Perkin Elmer (US), Promega Corporation (US), Beckman Coulter Inc. (US), Sigma Aldrich (US), Caliper Lifesciences Inc. (US), Thermo Fisher Scientific Inc. (US), and Xenometrix AG (Switzerland). ]]> https://biospectrumindia.com/news/97/6565/thermo-fisher-presents-ultra-low-temperature-freezer.html https://biospectrumindia.com/news/97/6565/thermo-fisher-presents-ultra-low-temperature-freezer.html Wed, 06 May 2015 14:18:17 +0530 Thermo Fischer Scientific launches TSX ultra-low temperature freezer which features natural refrigerants for lower environmental impact and higher cooling efficiency. Due to its intuitive design, the TSX freezer uses up to 50 percent less energy than conventional refrigerant ultra-low freezers and delivers temperature uniformity that continuously adapts to a laboratory's environment. "Energy efficiency is a feature most lab and biobank managers and sustainability officers look for when making purchasing decisions, but energy savings can come at the expense of sample integrity," said Mr Chris Champlin, vice-president and general manager, Controlled Temperature Technologies at Thermo Fisher Scientific. He added, "The new Thermo Scientific TSX ultra-low temperature freezer delivers unparalleled efficiency, noise reduction, and sample protection. Now, labs and biorepositories can not only reap the benefits of significant energy savings, but also feel confident that their samples are in an environment designed for their protection." Conventional ultra-low temperature freezers use single-speed compressors that continually cycle on and off, resulting in poor temperature recovery following door openings. The TSX ultra-low temperature freezer comes with the unique V-Drive technology. When conditions are stable, the V-Drive is designed to operate at a low speed to reduce energy consumption while maintaining a uniform temperature. When dealing with frequent door openings or when samples are added to the freezer, the control system detects the activity and increases the drive speed to bring temperatures quickly back to the set point. The V-Drive also helps limit sound output to 46 db(A), making the TSX freezer up to 20 times quieter, comparable to a conventional refrigerator. For busy labs and biorepositories, the constant, disruptive noise created by compressors can compromise communications and create a less-than-ideal working environment. What's more, the freezer utilizes water-blown foam insulation, which eliminates the off-gassing typical of urethane-insulated freezers.   Additional product features include a 600-box sample capacity to maximize storage within a 1.06m2 footprint, intuitive touch screen interface for access to vital freezer information, and on-board computer and USB port for data storage and exchange. The TSX ultra-low temperature freezer, will be displayed at the International Society for Biological and Environmental Repositories (ISBER) 2015 Annual Meeting and Exhibits.   ]]> https://biospectrumindia.com/news/97/6520/ibm-watson-collaborates-with-epic-and-mayo-clinic.html https://biospectrumindia.com/news/97/6520/ibm-watson-collaborates-with-epic-and-mayo-clinic.html Wed, 06 May 2015 12:32:36 +0530 IBM Watson Health has announced that it is collaborating with Epic and Mayo Clinic to advance patient health by applying the cognitive computing capabilities of Watson to Electronic Health Records (EHRs). As Watson's capabilities are applied to EHRs, patients and providers benefit from more rapid and thorough analysis of the medical factors that could impact an individual's health and wellness. Epic has more than 350 customers - some of the largest and most-recognized healthcare systems in the world - and they exchanged more than 80 million medical records in the last 12 months, both within and outside the Epic community. Interoperability with Watson will enable these institutions to apply the cognitive capabilities of Watson to these records through secure, cloud-based Watson services, providing greater clinical insight to help personalize healthcare. Together, Watson and Epic software could be used to develop patient treatment protocols, personalize patient management for chronic conditions, and intelligently assist doctors and nurses by providing relevant evidence from the worldwide body of medical knowledge, putting new insight into the hands of clinical staff. Providers will be able to share patient-specific data with Watson in real time, within workflows, allowing Watson to bring forth critical evidence from medical literature and case studies that are most relevant to the patient's care. Epic plans to embed Watson's cognitive computing capabilities into its advanced decision support offerings through the use of open standards, including Health Level -7 (HL7) Fast Healthcare Interoperability Resources (FHIR) Application Programming Interfaces (APIs). Connecting through Epic's open API, the two systems will extend clinician expertise and help caregivers access knowledge more quickly.   "Accessing Watson's virtual brainpower from the Epic platform is energizing from a creative standpoint. We are bringing another level of cognitive computing and augmented intelligence to mainstream healthcare, to improve safety and outcomes for patients globally," said Epic president, Mr Carl Dvorak. "Building on our recent announcement of IBM Watson Health, we are collaborating with Epic and Mayo Clinic in another important validation of the potential of Watson to be used broadly across the healthcare industry," said Mr Mike Rhodin, senior vice-president, IBM Watson. He added, "This is just the first step in our vision to bring more personalized care to individual patients by connecting traditional sources of patient information with the growing pools of dynamic and constantly growing healthcare information." IBM and Mayo Clinic are already working together to pioneer cognitive computing in clinical trials matching for cancer patients. Watson's speed and accuracy allows physicians to enroll patients more quickly in the clinical trials that best meet individual patient needs. Over one million patients are seen at Mayo Clinic each year and more than 1,000 clinical trials are available to match patients to at any given time. "Patients need answers, and Watson helps provide them quickly and more thoroughly. We are excited by Watson's potential to efficiently provide clinical trials information at the point of care," said Dr Steven Alberts, Mayo Clinic oncologist.     ]]> https://biospectrumindia.com/news/97/4139/a-new-sample-prep-guide-from-phenomenex.html https://biospectrumindia.com/news/97/4139/a-new-sample-prep-guide-from-phenomenex.html Wed, 06 May 2015 10:14:59 +0530 Phenomenex has announced the publication of a new sample preparation guide and selection tool to help scientists produce cleaner samples for more efficient chromatographic analysis. It is available online while a print version will be provided on request. The 50-page guide includes useful tools and resources to help select the most appropriate technique for any sample type. It also provides specific product recommendations, general methods and protocols for easy method development. "Phenomenex is rapidly expanding our sample preparation portfolio with new technologies, format options and improvements that makes it easier to effectively prepare samples prior to chromatographic analysis," commented Mr Allen Misa, brand manager for Phenomenex. "We also have an excellent dedicated sample preparation support team to assist users with specific challenges and questions." ]]> https://biospectrumindia.com/news/97/6346/mobile-health-garnered-282-million-in-venture-capital-funding-.html https://biospectrumindia.com/news/97/6346/mobile-health-garnered-282-million-in-venture-capital-funding-.html Mon, 04 May 2015 14:06:00 +0530 Funding into Healthcare Information Technology and Digital Health companies in Q1 2015 totaled $784 million in the first quarter of 2015. As per the data generated through its latest report, the Mercom Global has revealed that the mobile health (mHealth) companies accounted for 36 percent of total funding raised by digital health / health IT companies this quarter and also received the largest share (65 percent) of funding among consumer-focused companies, with $282 million in 56 deals (compared to $284 million in 41 deals in Q4 2014). Though funding fell across all technology groups this quarter, mHealth was the only area where funding levels did not decline significantly compared to the previous quarter. A total of 112 investors participated in mHealth funding rounds in Q1. GE Ventures was only investor that participated in multiple deals. Within mobile health, mHealth App companies captured the largest share bringing in $220 million in 35 deals. Last month, the Food and Drug Administration released the final guidance on mobile medical apps, bringing some much needed clarity and certainty to the mobile health market. The final guidance confirms a light, hands-off approach to regulating mhealth apps. Mobile health companies have received more than $2 billion in over 500 deals since 2010. Mobile health apps, in particular, have received about $900 million in more than 280 deals since 2010.   Care-focused apps led with the most deals followed by fitness/wellness/nutritions apps. The focus of care apps that received funding ranged from diabetes, cancer, parkinsons, cardiac health, chronic disease care and medication tracking among others. Some significant deals this quarter included Advance Health, a provider of a mobile patient data capture application for managed care providers, which raised $40 million from Summit Partners and Noro-Moseley Partners. ClassPass, a mobile membership app offering unlimited fitness and wellness classes across multiple gyms and studios to make working out more accessible also received $40 million from General Catalyst and Thrive Capital. Clinical Ink, a provider of point-of-care mobile data capture application for clinical trials, raised $20 million from MPM Capital, F2 Ventures, FCA Venture Partners and other investors. Glooko, a provider of an FDA-cleared mobile diabetes management app and a metersync device, received $16.5 million from Medtronic, Canaan Partners, The Social + Capital Partnership and Samsung's venture investment arm. Noom, a developer of health and fitness apps, raised $16.15 million from Han-Sing Hi-Tech Fund, TransLink Capital and RRE Ventures. Wearable Sensor companies logged $42 million in nine deals. A range of wearables including patches, bands, neckwear, implantable and disposable sensors were funded this quarter. Some large deals included Orthosensor, a company that develops sensor-based disposable orthopedic implants to help surgeons optimize placement of artificial knees and other clinical decisions, raised $19 million from Bridger Healthcare and Tullis Growth Fund. GlySens, a developer of a fully-implanted sensor-based continuous glucose monitoring system for people with diabetes, raised $12 million. Peerbridge Health, a developer of a wearable wireless vital sign monitoring sensor that provides heart rate and heart rhythm information to consumers, raised $4.89 million. Sproutling, a provider of a wearable health monitor designed for a baby's ankle, raised $4 million from BoxGroup, Forerunner Ventures, FirstMark Capital, First Round Capital, Lemnos Labs, Accelerator Ventures and Napster co-founder Shawn Fanning. Mobile Wireless technology companies with products like a wireless thermometer, a Bluetooth glucometer, wireless ECG and others recorded $21 million in 12 deals. Top deals included Atheer Labs, a provider of gesture-based 3D wearable smart glasses for use as a hands-free platform in operating rooms as well as to access medical records, which raised $8.8 million. Palo Alto Health Sciences, a developer of an FDA-cleared, at-home breathing system that trains individuals diagnosed with panic disorder to control their breathing and respiration, raised $3.9 million. Monica Healthcare, a fetal monitor developer, raised $3 million from Catapult Ventures, The New Hill Growth Fund, East Midlands Business Angels, The University of Nottingham, Wren Capital, Origin Capital, Catamaran Ventures and the London Business Angels, and other investors. ]]> https://biospectrumindia.com/news/97/6752/toshiba-and-nsta-announce-2015-winners-of-exploravision-.html https://biospectrumindia.com/news/97/6752/toshiba-and-nsta-announce-2015-winners-of-exploravision-.html Mon, 04 May 2015 12:56:05 +0530 From a hearing aid powered by the body's thermal energy to an external microbial cleansing device designed to capture pathogens in the blood stream, the young winners of the Toshiba/NSTA (National Science Teachers Association) ExploraVision competition have dreamed up a wide array of innovative technologies that could help build a better future. The program has announced the national winners of the world's largest K-12 science and technology competition, which is designed to build problem-solving, critical thinking and collaboration skills that are central to the Next Generation Science Standards. The Toshiba/NSTA ExploraVision program challenges participants to imagine what technology might be like in 20 years. Students work in teams to propose ideas for innovative future technology based on a challenge of what already exists, simulate real scientific research to outline how they plan to test their idea, and build websites to further illustrate and communicate their concepts. Since its inception in 1992, nearly 350,000 students have participated in the ExploraVision program. This year, 5,041 team projects were entered in the competition representing 15,473 students from across the United States and Canada. "This year marks the 50th anniversary of Toshiba's operations in the United States, and throughout this period, the company has maintained a strong commitment to technological innovation. The ExploraVision program represents this ideal, and continues to be the cornerstone of Toshiba's Corporate Social Responsibility initiative in North America. We are extremely proud to see ExploraVision continue to succeed in its 23rd year, inspiring students to explore and develop a passion for the STEM subjects that are vital for our future," said Mr Masaaki Osumi, Toshiba America's chairman and CEO, and Toshiba's corporate representative for the Americas.   "The caliber of the projects entered in the Toshiba/NSTA ExploraVision competition serve as an inspirational reminder of the ingenuity that comes from igniting students' natural curiosity in science. These students are developing innovative solutions to show how our society can do things better and more efficiently, and we couldn't be more excited to showcase their projects. We congratulate the national winners and commend all of the teachers for engaging and empowering their students to make a real difference in the world around them," said Dr Juliana Texley, president, NSTA. This year, several winning student teams focused on disease prevention and improving treatment for the disabled. Tenth grade students from Salem, Oregon developed The Suture of the Future device, which uses Programmable Bio-Scaffolding (PBS) technology and stem cells to help patients who take blood thinners heal quickly and safely from open wounds. PBS technology accelerates the healing process by precisely scaffolding wounds by binding edges of the cut together with premature stem cells. A team of 10th grade students from Duluth, Georgia, created the External Microbial Cleansing Device (EMCD). The EMCD functions with the aid of magnetic nanobeads attached to artificially engineered human opsonin-mannose-binding lectins (MBLs) that have the capability to capture a wide variety of pathogens in the blood stream. With the availability to deliver enriching nutrients, monitor blood, and develop medical reports, the technology will drastically improve the outcome of those with pathogenic diseases. National winners also focused on making the world more environmentally friendly. Fourth grade students from Land O'Lakes, Florida, created The Green Tablet in an effort to reduce e-waste generated each year from the disposal of electronic devices. Members of the four first place ExploraVision national winning teams will each receive a $10,000 US Series EE Savings Bond (at maturity). Members of second place national winning teams will each receive a $5,000 US Series EE Savings Bond (at maturity).     ]]> https://biospectrumindia.com/news/97/3818/bosch-to-unveil-granulean.html https://biospectrumindia.com/news/97/3818/bosch-to-unveil-granulean.html Mon, 04 May 2015 12:52:11 +0530 Bosch Packaging Technology will introduce the new granulation unit, GranuLean at Achema 2015 to be held in Germany from June 15 to 19, 2015. Developed by the Bosch subsidiary Hüttlin GmbH, it combines the process steps of mixing, granulating and drying for the manufacturing of pharmaceutical granules. "The name GranuLean stands for a lean and compact machine, which can be easily integrated into production rooms and focuses on the basic requirements of pharmaceutical producers. By concentrating on the essential basic functions within fixed dimensions, we have developed an especially efficient granulation solution," said Mr Fritz-Martin Scholz, product manager at Bosch Packaging Technology. The GranuLean for instance saves valuable production room with its 6 meters length and 3.4 meters height. The new development is available for three different batch sizes and is based on Hüttlin's long-standing process technology experience. As opposed to tailor-made granulation lines, the most important functions of GranuLean are installed by default. "The high level of standardization now enables us to fulfill customer demands for a complete and quickly available system at the accustomed high quality," said Mr Scholz.   The granulation unit can be installed quickly and easily. All process and cleaning steps can be controlled via recipes. The operator interface is a 21-inch touchscreen with user-friendly navigation. GranuLean is available for a containment level of up to OEB3 (Operational Exposure Band). The machine remains closed during operation, while inflatable seals on the product containers provide for an optimum draughtproofing. Moreover, the integrated cleaning system ensures an even easier handling.   ]]> https://biospectrumindia.com/news/97/5511/toshibas-new-offering-for-pediatric-patients-.html https://biospectrumindia.com/news/97/5511/toshibas-new-offering-for-pediatric-patients-.html Thu, 30 Apr 2015 14:14:53 +0530 Toshiba has created comprehensive solutions for a variety of pediatric imaging needs across all its modalities:• Superb Micro-Vascular Imaging (SMI) ultrasound technology: Allows clinicians to see smaller vessels, giving way to faster, non-invasive disease diagnosis and expanding the utility of ultrasound, which results in fewer ionizing procedures for safer pediatric care.• Pediatric-friendly MRI: Toshiba's patented PianissimoTM technology significantly reduces the noise in and around the MRI environment, allowing for a safer and more comfortable exam for even the smallest patients. Toshiba's Pediatric SPEEDERTM Coil Suite provides added flexibility for pediatric patients of a wide age range, helping to improve image quality. Additionally, Toshiba's proprietary non-contrast techniques eliminate the need for contrast injections for certain procedures, for a safer and more pediatric-friendly exam.• Interventional radiology: Toshiba's InfinixTM bi-plane and single-plane labs have pediatric specific capabilities designed by pediatric interventionalists to ensure pediatric patients receive the safest exams possible. Spot Fluoroscopy with Last Image Hold, Toshiba's award-winning Dose Tracking System (DTS) and Live Zoom fluoro and acquisition (at up to 2.4 times lower dose than traditional FOV changes) are all designed to minimize X-ray exposure while maintaining image quality.• Safer X-ray exams: Toshiba's RADREXTM-i digital radiographic X-ray RexProtect features set a new standard of safety and lower dose for even the smallest patients.• Low-dose CT exams: Advanced dose reduction technologies-like SUREExposureTMPediatric for "child-size" exams, and AIDR 3D tolower dose while maintaining high image quality-help limit radiation exposure to more sensitive pediatric patients. "Toshiba is committed to ensuring that pediatric patients have the safest imaging experience possible," said Calum Cunningham, vice president, Marketing and Strategic Business Development, Toshiba. "By incorporating technologies that are aimed at reducing radiation exposure, creating safer X-ray exams, making our systems patient-friendly and more, we are improving pediatric safety and enhancing the overall patient experience." Toshiba will be featuring these technologies at this year's Society of Pediatric Radiology (SPR) annual meeting in Bellevue, Wash., April 27-May 1, 2015 (Booth #21). ]]> https://biospectrumindia.com/news/97/6917/medtronics-stent-can-improve-neurological-outcome.html https://biospectrumindia.com/news/97/6917/medtronics-stent-can-improve-neurological-outcome.html Thu, 30 Apr 2015 13:41:00 +0530 In the "New England Journal of Medicine" (NEJM) published online and inthe European Stroke Organization meeting reported on the two global trials show that in the existing drug treatment Canada with Solitaire instrument stand except thrombectomy, can significantly reduce stroke disability. These tests confirmed the same NEJM published in three previous trials of results. Both trials SOLITAIRE TM FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (except thrombectomy as the acute ischemic stroke major vascular treatments SOLITAIRE TM FR, referred to as the "SWIFT PRIME") and Endovascular Revascularization Solitaire with Versus Best Medical Device Therapy in Anterior Circulation Stroke Within 8 Hours (anterior horn loop stroke within 8 hours using Solitaire equipment for intravascular revascularization vs best medical treatment, referred to as "REVASCAT"), to assess acute ischemia stroke (AIS) patients in the conventional medical treatment (including when using the IV-tPA patients qualify) the addition of Solitaire equipment, which is lighter than stroke-related disability in patients with IV-tPA alone or medical therapy. SWIFT PRIME by the Medtronic (Medtronic plc, NYSE: MDT) sponsorship, while REVASCAT was supported by Medtronic provides a non-limiting funding. SWIFT PRIME assessment of 196 patients showed that the addition of Solitaire instruments significantly reduce disability after stroke, increasing stroke within 90 days after the functional independence of the number of cases. The trial showed that patients with Solitaire plus instrument, its functional independence recovery rate was significantly higher than that with IV-tPA (60.2% vs. 35.5%, p = 0.0002).University of California Los Angeles (UCLA) Geffen School of Medicine professor of neurology, director of the UCLA Stroke Center Comprehensive Jeffrey L. Saver, MD, FAHA, FAAN, FANA said: "SWIFT PRIME display, Solitaire device therapy is safe, technically successful It can significantly reduce long-term disability. The therapy marks the beginning of a new era in the treatment of stroke. " Similarly, REVASCAT (206 patients) showed that the onset of symptoms within eight hours, in medical treatment (including the use of IV-tPA in eligible patients, 70% of enrolled subjects) added with Solitaire treatment equipment Patients recover its functional independence higher than medical therapy alone (43.7% vs. 28.2%), the difference was statistically significant. SWIFT PRIME and REVASCAT also confirmed that the same three global test published in the NEJM results: Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial (extended thrombolysis for emergency neurological disorder - time intra-arterial, hereinafter referred to as "EXTEND-IA"), Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (endovascular treatment for small core and proximal obstructive ischemic stroke, hereinafter referred to as "ESCAPE") and Multi center Randomized Clinical trial of Endovascular treatment for Acute ischemic Stroke in the Netherlands (endovascular treatment for acute ischemic stroke - Dutch multicenter randomized clinical trial, hereinafter referred to as "MR CLEAN"). These tests have shown that the time delay before treatment can significantly affect the outcome.Compared with the previous test, SWIFT PRIME workflow (from diagnosis to treatment of the entire treatment period) were significantly improved. The trial in seven countries, 39 centers, show a different health care system in a wide range of applicability, as well as fast, efficient stand except thrombectomy of treatment can reach.   REVASCAT comprehensive stroke centers in four Spanish region of Catalonia carried out, this four centers cover 7.5 million people. From the general population, the group of patients in line with the program, 85% enrolled in this trial. REVASCAT trials, the eligibility criteria broad and achieve a high number of the group, therefore, a positive outcome Solitaire instrument for most stroke patients in Catalonia is universal. Antoni Davalos Germans Trias i Pujol University Hospital, director of the Department of Neuroscience, MD said: "We now have five of the global clinical trials to provide overwhelming evidence base to support the Solitaire stent except thrombectomy based on these results, the stroke community converged. re-evaluate the timing of stroke treatment guidelines together, exploring the new system is up, which will promote specialized centers to treat patients for accessibility. " Solitaire instrument uses an extremely small size of the catheter is inserted through the leg incision stroke involving brain artery.Once placed in place, Solitaire instruments can help immediately to restore blood flow, eliminate blood clots causing stroke. Medtronic rehabilitation Brett Wall neurovascular president of Division Ministry, said: "These results are the global stroke care community gathered together, rethink our offer stroke treatment methods .Solitaire instrument stand except thrombectomy has been verified to improve the procedure For patients of access, we are committed to overcome the stroke of important goals of all parties. We support the revised guidelines, a move that will benefit the patient and the health care system and the wider society. "   ]]> https://biospectrumindia.com/news/97/6031/fda-nod-for-siemens-mammography-platform.html https://biospectrumindia.com/news/97/6031/fda-nod-for-siemens-mammography-platform.html Thu, 30 Apr 2015 13:40:41 +0530 The Food and Drug Administration (FDA) has approved the MAMMOMAT Inspiration with Tomosynthesis Option - the breast tomosynthesis add-on option for Siemens Healthcare's MAMMOMAT Inspiration digital mammography platform. Siemens' breast tomosynthesis algorithm reconstructs multiple 2D images of the breast into an approximation of a 3D image to enable detection of tumors that are hidden by overlapping breast tissue, enabling more accurate diagnosis than standard 2D digital mammography and reducing the number of false-positive findings. In a recent study involving 22 readers with a broad range of reading experience, Siemens demonstrated that all readers improved their accuracy in detecting and diagnosing cancers when reading digital breast tomosynthesis as an adjunct to full-field digital mammography. In tomosynthesis mode, the X-ray tube of the MAMMOMAT Inspiration digital mammography system rotates in a circular motion around the breast to acquire an image every two degrees while moving through an angular range of 50 degrees. The resulting 25 projections are reconstructed as three-dimensional (3D) digital breast tomosynthesis (DBT) images. Conventional analog mammography and full-field digital mammography display only the 3D structure of the breast on a 2D level, hampering physicians' efforts to identify certain types of tumors since anatomical structures in the breast can overlap and obscure lesions. Tomosynthesis acquires several breast projections from different angles and uses raw data to generate a 3D volume set. Using this data set, clinicians can better analyze the type and size of breast lesions as well as microcalcifications compared to other forms of mammography. Breast tomosynthesis increases mammography's sensitivity and specificity, in addition to improving efforts to differentiate and classify breast tumors. "Our clinical data has demonstrated that the addition of Siemens' digital breast tomosynthesis to a patient's traditional 2D digital mammogram increases detection of breast tumors. We know that in clinical practice, this increased diagnostic accuracy also means fewer diagnostic biopsy procedures and fewer anxiety-inducing recalls, which typically contributes to both improved patient outcomes and reduced cost," said Mr Gregory Sorensen,president and CEO of Siemens Healthcare North America. "With the FDA approval of the MAMMOMAT Inspiration with Tomosynthesis Option, Siemens Healthcare reaffirms its longstanding commitment to cutting-edge innovation in women's health."   ]]> https://biospectrumindia.com/news/97/3684/syngene-files-drhp-seeks-approval-for-ipo.html https://biospectrumindia.com/news/97/3684/syngene-files-drhp-seeks-approval-for-ipo.html Wed, 29 Apr 2015 15:45:00 +0530 This is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. Biocon along with its subsidiary Biocon Research Limited (BRL) currently holds an 84.5 percent equity stake in Syngene. Biocon is offering to sell up to 22 million equity shares of face value of Rs 10 each, through Syngene's IPO. The offer includes a reservation of 2 million equity shares for Biocon's public equity shareholders, being individuals and HUFs. The offer would constitute 11 percent of the post offer paid-up equity share capital of the Company.   Syngene has reported revenues of Rs 7,077 million for the previous financial year ended March 31, 2014 and Rs 6,175 million for the nine months period ended Dec 31, 2014. Commenting on the development, Dr Kiran Mazumdar-Shaw, CMD, Biocon, said, ".....Syngene has attracted equity participation from India Value Fund recently, which is reflective of the scale, the value and the quality of the differentiated business model of Syngene." "We are unlocking value from Syngene to fund our R&D programs, which include a rich pipeline of biosimilars and novel biologics. This fund infusion will help accelerate these programs which are at various stages of development currently," she added. Syngene has commenced the process of establishing a new commercial-scale facility in Mangalore to manufacture novel small molecules for innovator companies in pharmaceutical, agrochemical and other industrial sectors. It has also expanded its current small molecule manufacturing facilities in Bangalore to meet the interim manufacturing needs of its clients. Additionally, it is in the process of expanding its large molecule manufacturing capabilities by establishing a new unit in Bangalore. On January 12, 2015, Biocon Research Limited (a wholly owned subsidiary of Biocon) transferred a 10 percent stake in Syngene to IVF Trustee, sole trustee of India Value Fund IV, for a consideration of Rs 3,800 million. The Equity Shares being offered are proposed to be listed on the BSE and the National Stock Exchange of India post necessary consents and approvals being received. ]]> https://biospectrumindia.com/news/97/6428/ge-healthcare-announces-new-ceo-for-south-asia.html https://biospectrumindia.com/news/97/6428/ge-healthcare-announces-new-ceo-for-south-asia.html Wed, 29 Apr 2015 15:41:30 +0530 GE South Asia and Wipro have announced the appointment of Mr Milan Rao to lead GE's Healthcare business as President and CEO, GE Healthcare South Asia and managing director, Wipro GE Healthcare. Mr Milan will build on Wipro GE's expansion plans and continue to strengthen the company's 'In India, for India' proposition of innovating disruptive technology and business solutions to enhance access to high quality, affordable healthcare solutions. Effective May 1, 2015, he replaces Ms Terri Bresenham, who has been leading GE Healthcare's South Asia business since September 2011. Mr Milan will report to Azim Premji, chairman, Wipro and Mr Banmali Agrawala, president and CEO, GE South Asia. Mr Banmali Agrawala, president and CEO, GE South Asia said, "Mr Milan will take GE's mission of a Healthier India forward through development of disruptive technologies and business models in India, for India. Our Healthcare business reinforces our philosophy of creating localized and affordable solutions. I thank Terri for her contribution and am confident that Milan will carry forward GE's legacy of striving to develop solutions that meet the needs of the Indian healthcare sector." "Wipro and GE have enjoyed a strong and enduring partnership lasting over 25 years that has made an indelible mark on India's healthcare industry. I am confident Milan will further strengthen this relationship and give an added impetus to our mission to build a healthier India," said Mr Azim Premji, chairman, Wipro. Mr Milan joined Wipro GE Healthcare in August 2013 as Chief Operating Officer. He has over 20 years of senior management and leadership experience in several industries including Telecom, Financial Services and FMCG.   Speaking about his new role, Mr Milan said, "Wipro GE has achieved several milestones on the promise of delivering affordable and accessible healthcare. I am looking forward to expand our leadership in the market, accelerate innovation and distribution capabilities to continue enhancing customer centricity and technology adoption for quality healthcare diagnosis everywhere. We hope to build on our successes in local innovation, partnership with all Governments and healthcare providers to achieve our vision of a healthier India and also help transform lives world over."    ]]> https://biospectrumindia.com/news/97/6400/govt-approves-materio-vigilance.html https://biospectrumindia.com/news/97/6400/govt-approves-materio-vigilance.html Wed, 29 Apr 2015 13:08:25 +0530 According to the Health Minister Mr JP Nadda, as a part of the program, adverse events associated with medical devices will be reported online to the nodal collaborating center. "As part of the program, adverse events associated with medical devices will be reported online to the nodal collaborating center. Such events will thereafter be analyzed by the technical committee and based on the findings of the committee, further action as considered appropriate will be taken," said the minister in a statement. He further said that inputs other than those received from the program will also be used to ensure the authenticity of such devices.     ]]> https://biospectrumindia.com/news/97/6395/toshiba-adds-new-prodcuts-to-its-portfolio.html https://biospectrumindia.com/news/97/6395/toshiba-adds-new-prodcuts-to-its-portfolio.html Wed, 29 Apr 2015 12:33:34 +0530 Toshiba has announced the launch of a Hardware Development Kit (HDK) and a Software Development Kit (SDK), able to monitor activity levels, take a pulse and check heart rate, that together form a development platform for the TZ1000 series application processor for wearable and IoT devices. Toshiba will start supplying IoT device developers with the HDK and SDK on May 7th, and also conduct a trial campaign that will offer a limited quantity of reference boards and its development environment free of charge. TZ1000 series devices integrate a sensor, a processor, flash memory, and a Bluetooth Low Energy controller in one package and are designed as a single-device solution for measuring, processing, saving and communicating data required for wearable and IoT devices. The development environment includes an HDK embedded with the TZ1000 series TZ1001MBG processor, the SDK that operates on it, software development tool support and documentation. The kits will allow users to evaluate and develop software in an environment closer to final products and to optimize use of the application processor for specific product characteristics compared with previous development environment. The development environment will contribute to reduce design man-hour requirements and product development periods.   Toshiba is also working on the development of a software algorithm to measure weak biological signals, like pulse waves and the heart's electrical activities, and environmental data such as temperature and humidity, and aims to supply a system solution in the TZ1000 series that will further strengthen the line-up.     ]]> https://biospectrumindia.com/news/97/6779/icon-launches-electronic-informed-consent-.html https://biospectrumindia.com/news/97/6779/icon-launches-electronic-informed-consent-.html Wed, 29 Apr 2015 08:27:00 +0530 ICON has announced the launch of Firecrest eConsent, a next-generation electronic informed consent solution that incorporates key recommendations from the FDA's recent draft guidance on informed consent. The e-Consent solution is a component of ICON's new informatics hub designed to enhance the engagement of patient populations in the development process. One of the critical parts to improving this engagement is improving the informed consent process. Addressing the FDA's recommendation for a more patient centric approach for presenting clinical trial information, ICON's Firecrest eConsent employs videos and visual aids to assist in the explanation of complex scientific concepts and medical terms found in trial protocols. These educational techniques were developed based on research by Carnegie Mellon University, and have been systematically tested, to facilitate optimal patient comprehension and information retention. Firecrest eConsent enables patients to access materials via portals or through other online channels provided by the sponsor, giving patients more time to independently review and prepare questions for the physician before subsequently consenting to participate in the trial. Conforming with the FDA's requirement for validating that e-signatures are written by the actual patient, Firecrest eConsent uses a new proprietary method to capture, confirm, encrypt, and store biometrics for each patient's signature. Firecrest eConsent has also been designed to be compatible with sites' existing IT infrastructure, enabling sites to adopt the Firecrest eConsent solution quickly and efficiently. "Electronic informed consent helps address one of the leading causes of regulatory findings - errors in the consent process in current paper-based processes. Firecrest eConsent simplifies and provides transparency in the entire patient consent process. It thoroughly and consistently explains the trial, which instils trust in the patient, and it also offers sponsors a secure and easy-to-implement solution to drive patient enrolment and reduce the opportunities for protocol violations," said Mr Frances Abeton, vice-president, Firecrest.   ]]> https://biospectrumindia.com/news/97/4701/pharmalab-launches-a-new-derouging-system.html https://biospectrumindia.com/news/97/4701/pharmalab-launches-a-new-derouging-system.html Tue, 28 Apr 2015 16:29:56 +0530 Pharmalab has announced the launch of the Borer Deconex Derouging Solution. Rouging is an inversion of the passive layer rich in chromium-oxides to a porous layer rich in iron-oxides. This encourages the formation of iron-oxide and other metal oxides and causes the surface to change colour. This is particularly in the case when the surfaces are exposed to hot, low ion and low oxygen for extended period of time e.g. in the plants that produces purified water (PW), water for injection (WFI), Autoclaves or in tanks. It is typically characterized by reddish brown staining on stainless steel surface in isolated form. The advantages of Borer Deconex Derouging Solution are that it shortens process time therefore, longer duty cycles for production equipment. This is a pH neutral process hence solutions and rinsing water do not require neutralizing. It increases safety at work as high concentration of aggressive acids are not required. It is simple in process control therefore monitoring of derouging solution effectiveness does not require expensive analytical instrument. Also, rapid results leads to short derouging cycle time and improved efficiency. The low concentration leads to a cost effective application. Excellent material compatibility. Longer life cycle for process equipment. Does not contain halogenides hence no chemical attack on surfaces. The solution validates analytical methods, therefore, allow a residue free process. Well established analytical procedures enables a rapid transfer of the derouging process. The Deconex DEROUGE system is especially suited to the derouging of production systems, storage tanks and distribution system of water (PW & WFI), pure steam systems, process vessels e.g. in vaccine production, Autoclaves, and lyophilizers.         ]]> https://biospectrumindia.com/news/97/6712/aimed-ima-sign-a-mou-to-promote-cure-in-india.html https://biospectrumindia.com/news/97/6712/aimed-ima-sign-a-mou-to-promote-cure-in-india.html Tue, 28 Apr 2015 09:44:00 +0530 Association of Indian Medical Device Industry (AIMED) and Indian Medical Association (IMA) have signed a MoU to promote 'Cure in India' initiative for driving medical tourism within India and simultaneously promote 'Buy Indian' which encourages use of India manufactured devices in healthcare sector along with Indian medical expertise. Under the scheme of things, IMA will encourage medical fraternity to go 'One Step beyond Endorsement' for India manufactured medical devices which would be approved by IMA based on stringent internationally accepted quality parameters. As per the MoU, IMA and AIMED will establish joint mechanism to promote Indian medical device industry and under their 'Cure in India' initiative will give users and consumers access to 'IMA preferred Brands of Safe Indian Medical Device' that are affordable. The move is likely to have a huge positive impact on 'Make in India' program while giving a big shot to manufacturing of medical devices within the country and bring esteem to the Indian Industry & Nation thereby building Brand India . "This MoU will give a big push to manufacturing and innovation in Indian medical device industry while promoting Indian healthcare sector as a whole. This initiative will also help reduce country's huge import dependency in medical device sector while encouraging exports," said Mr Rajiv Nath, forum co-ordinator of AIMED. "IMA is of the view that for those consumables and devices which are manufactured in India and approved by appropriate authorities, no reimbursement should be given to foreign devices," said Padma Shri awardee, Dr KK Aggarwal, honorary secretary general ,IMA. Under the joint mechanism, both associations will soon roll out promotional campaigns to achieve the objectives of this MoU.   ]]> https://biospectrumindia.com/news/97/6427/practo-announces-the-acquisition-of-fitho.html https://biospectrumindia.com/news/97/6427/practo-announces-the-acquisition-of-fitho.html Mon, 27 Apr 2015 15:20:25 +0530 Practo has announced acquisition of Fitho Wellness, a digital fitness solution that has over two million users across the globe. The acquisition will help Practo rapidly expand its offerings and move into the preventive healthcare space. It will also bring the company closer to its goal of making it  the single health app consumers need. The founders of Fitho, Mr Dhruv and Ms Prachi Gupta will join Practo, with Mr Dhruv taking on the role of product head for Preventive and Ms Prachi taking on the role of GM - Operations, New Segments. Practo also acquires the proprietary algorithm and recommendation engine which automatically suggests custom diets and exercise regimes to users based on their lifestyle, fitness requirements and food preferences. FitHo's current offering will phase out over the next six months and Practo will launch a completely new preventive product that will leverage some of the technology from FitHo. "This is the first of several acquisitions we are exploring. It is the next step in our mission to make a single health app which offers consumers a more comprehensive solution ranging from preventive to curative healthcare. The FitHo team brings on-board enormous talent and expertise to help us tap into the preventive segment. I am very excited to have them join us and look forward to building new and exciting products for consumers with them," said Mr Shashank ND, founder and CEO, Practo.   "We're really excited to join Practo and integrate our technology and expertise with Practo's offerings. Together we will be able to offer consumers interesting and unique solutions that are more comprehensive than either of us had before. We also find a great cultural fit with Practo where the discussions have been very collaborative about building great products and businesses together. I love the energy and passion that Practo team has for transforming healthcare and look forward to working with Shashank and the team to build some exciting products," said Mr Dhruv Gupta, founder and CEO, FitHo.     ]]> https://biospectrumindia.com/interviews/97/4487/chennai-has-become-a-major-hub-for-the-cro-industry.html https://biospectrumindia.com/interviews/97/4487/chennai-has-become-a-major-hub-for-the-cro-industry.html Mon, 27 Apr 2015 10:39:00 +0530 Could you give a brief outline of Quest's services?Quest Life Sciences is a clinical research organization. We specialize in the conduct of Bioequivalence/Bioavailability studies for the generic pharma industry. Besides we conduct Phase II to Phase IV clinical trials on patients in hospitals. Our major strength is technical support that we provide to the clients from IVIVC guidance to designing the protocol and implementation of the clinical trials. We have conducted nearly 1000 trials so far in a period of last 10 years. Has the company forayed into countries outside India?The biggest advantage of clinical trials in India is the vast pool of subjects, disease profiles and ability to induct volunteers or patients in the shortest possible time. This coupled with a scientific pool of highly qualified and experienced pharmaceutical scientist has made India the centre for clinical trials across the world. In effect every pharmaceutical company in the world has recognized India's capabilities and advantages. So naturally we are gradually expanding our operations all over the world. Currently we have offices or Resident Managers in the US, Moscow and Thailand. Our main target is the regulated market. We now see a huge opportunity even in Rest of the World (RoW) market. Rules are becoming stringent day-by-day. Some countries such as Mexico, Thailand, and Russia have made it mandatory that all the clinical trials and BE studies to be conducted in their respective countries only. Quest has recently acquired Fortis Clinical Research? What was the reason to choose Fortis and could you elaborate on the financial details of the transaction? Quest Life Sciences is indeed very happy to have been able to acquire the entire assets of FCRL. FCRL is one of the established CROs in India and having several regulatory approvals such as USFDA, MHRA UK, ANVISA, and EMEA GERMANY, to name a few.   The promoters of FCRL are Mr Malvinder Singh and Mr Shivinder Singh, former major shareholders of Ranbaxy. When Sun Pharma acquired Ranbaxy, FCRL decided to hive off FCRL as it was run by them as an extension of Ranbaxy. The sale of FCRL assets come at the most opportune time for us when Quest Life Sciences is in the advanced stage of setting up a state-of-the-art CRO facility in Gujarat. Quest Life Sciences was able to save substantial in the acquisition of FCRL assets and put to use each and every capital item. In addition, Quest Life Sciences has taken over the regulatory services of FCRL. We are therefore getting not only the assets but also the goodwill of the FCRL clients. Is the company looking at foreign private equity funds? Quest Life Sciences is in the advanced stage of signing with an international private equity funds investment banker. How would you evaluate the Chennai CRO industry, its growth and how do you plan to carve a niche despite stiff competition in Chennai?Chennai has become one of the major hubs for the CRO industry and has made remarkable growth in the last 5 years. However, Quest Life Sciences has a unique advantage of having served several leading international clients and large Indian Multinationals. The professional team of Quest Life Sciences has by far the best credentials in terms of qualification, experience and with the strong regulatory updates. Quest Life Sciences is the only CRO situated in the Special Economic Zone (SEZ) of Chennai. In Chennai, what kind of drugs is most commonly evaluated in clinical trials and what is Quest's experience in serving the trials?The clinical trial industry broadly covers generic drugs for BA/BE studies. This includes, oncology, dermatology, cardiovascular, ophthalmology and biosimilar studies. Quest Life Sciences is India's US FDA-approved Contract Research Organization and among the top 10 CROs in India, which was established in 2004 in Chennai, India. Quest Life Sciences caters to the technical needs of pharmaceutical industries for the conduct of BA/BE studies, clinical trials, clinical data management, bioequivalence, oncology trials, phase I trials, regulatory submission to the global drug regulatory agencies. (By Anusha Ashwin) ]]> https://biospectrumindia.com/news/97/8304/syngene-likely-to-go-public-this-july.html https://biospectrumindia.com/news/97/8304/syngene-likely-to-go-public-this-july.html Fri, 24 Apr 2015 13:00:49 +0530 "The DRHP (Draft Red Herring Prospectus) is likely to be filed today," a Syngene spokesperson told Business Standard. Incorporated in 1993, Syngene offers integrated discovery and development services to pharma and biotech, agro-chemical as well as other industries. Recently in 2015, Clinigene International, a fully-owned subsidiary of Syngene, involved in drug discovery and development CRO, was incorporated into Syngene. ]]> https://biospectrumindia.com/news/97/6505/social-media-usage-by-pharma-cos-on-the-rise-ogilvy.html https://biospectrumindia.com/news/97/6505/social-media-usage-by-pharma-cos-on-the-rise-ogilvy.html Thu, 23 Apr 2015 14:27:56 +0530 A new report by Ogilvy Healthworld highlights who leads the way in integrated social media marketing The average number of tweets by pharma has gone up by 530 percent since 2013, and twitter followers have increased by nearly 300 percent, said Ogilvy's report. Pharma companies with the biggest communities aren't necessarily the most effective at engaging with their users and generating interest. Followers reward pharma companies who post frequently and engage continuously -- those that keep their networks fresh with regular updates have the highest interaction from the community. The report 'Connecting the Dots: Which Pharma Companies are Succeeding in the Social Media Space?' is the first of its kind to provide insights into which pharma companies are leading the way in integrated social media marketing strategies.   The report reveals a small group of companies are 'connecting the dots' and leading the way in social media. They are providing useful content that is both relevant to their marketing objectives and audience needs. They are engaging with consumers, healthcare professionals and media consistently on all of their networks in a way that encourages followers to contribute to the conversation. The report also draws some conclusions on social media best practice. To succeed, pharma companies need to be brave and prepared to have honest and meaningful conversations about their brands.   This involves developing strategies and mapping out potential scenarios with internal stakeholders to respond as quickly as possible to their followers, Ogilvy said. They should aim to provide content that is relevant to their audience also have a clear set of engagement guidelines to help manage difficult questions. "We know that some pharma companies have been cautious in their approach to social media, but our report clearly demonstrates a dramatic and successful increase in activity," said Ms Rebecca Canvin, social media manager, Ogilvy Healthworld. She further added, "Social media has changed the way pharma companies communicate -- it allows them to build corporate reputation and engage in genuine, meaningful conversations with audiences. For companies who want to stand out from the crowd it's time to be brave, get personal, educate and integrate social media into their wider marketing strategy." The data for the report was gathered by monitoring 10 of the most popular networks for 14 pharma companies across six categories: social presence, social network, community size, activity, engagement and activity. The profile of each company was reviewed for one week per month for three months during 2014 to ensure sufficient data was collected, said the company's release. ]]> https://biospectrumindia.com/news/97/6199/dupont-acquires-taxon-biosciences.html https://biospectrumindia.com/news/97/6199/dupont-acquires-taxon-biosciences.html Thu, 23 Apr 2015 12:31:50 +0530 This acquisition will build on DuPont's in-house capabilities and unparalleled market access in both seed and crop protection to discover and commercialize biological solutions for agriculture customers globally. "In 2014, the businesses in DuPont's agriculture, nutrition and health and industrial biosciences segments sold more than $1 billion in biological solutions across four market sectors. Our in-house, cross-business venture, DuPont Biologicals, draws on our world-class science and deep understanding of food and production agriculture markets to deliver value-added crop biological solutions," said DuPont's EVP Mr James C Borel. "Taxon has built a leading technology platform for the discovery of microbial based products that will further strengthen our capabilities in biologicals," he added. Based in California, Taxon was founded in 2000 by leading microbial geneticists Dr Matt Ashby and Prof Jasper Rine, with the objective of developing a transformational microbial genomics platform to solve critical challenges in agriculture, energy and health sciences. The company holds a broad intellectual property estate in the field of microbial consortia and microbial genomics products which will contribute to the development of new DuPont seed treatment, foliar and soil application products for important row crops, fruits and vegetables. "The acquisition of Taxon will complement and enhance our in-house microbial discovery programs," said Mr Frank DeGennaro, director, DuPont Biologicals. "With this added capability, we expect to accelerate our time from discovery-to-market and we are field testing biological discovery leads identified by Taxon this year." ]]> https://biospectrumindia.com/news/97/4977/agilent-announces-resolution-to-fda-warning-letter-.html https://biospectrumindia.com/news/97/4977/agilent-announces-resolution-to-fda-warning-letter-.html Thu, 23 Apr 2015 11:01:24 +0530 Agilent Technologies has announced that its subsidiary, Dako Denmark A/S, has received a close-out letter from the US Food and Drug Administration (US FDA) with respect to the warning letter issued Aug 21, 2013. The FDA informed Dako Denmark that it has completed its evaluation of Dako's corrective actions and that it appears Dako has addressed the violations contained in the warning letter. The warning letter, issued by the FDA's Center for Devices and Radiological Health, focused on Dako's quality management processes for complaint handling, corrective and preventive actions, statistical techniques and process validation. The letter was the result of an inspection the FDA performed at Dako's facility in Glostrup, Denmark, in March 2013. "We are pleased with this outcome. It underscores our commitment to maintaining a compliant and superior quality management system, and to delivering products that are of the highest quality," said Mr Mike McMullen, president and CEO, Agilent.     ]]> https://biospectrumindia.com/news/97/6462/biotime-partners-with-beckman-research-institute.html https://biospectrumindia.com/news/97/6462/biotime-partners-with-beckman-research-institute.html Thu, 23 Apr 2015 10:59:56 +0530 BioTime has announced a non-exclusive license agreement between BioTime's subsidiary ES Cell International (ESI) and Beckman Research Institute of the City of Hope through which ESI's clinical-grade human embryonic stem (hES) cells will be manufactured and provided to BRICOH's clinical collaborators, including medical research organizations intent on using the hES cells to develop and commercialize therapeutic products to treat human disease. The agreement is a critical part of BioTime's strategy to leverage third party funding and generate future revenues by placing its hES cells in programs developing a wide array of therapeutic applications made possible with pluripotent stem cell technology, products that are currently not being developed by BioTime or its subsidiaries. Successful medical research organizations will need to obtain separate licenses from BioTime in order to advance their products based on ESI's hES cells into clinical trials and commercialization. These licenses may entitle BioTime to receive additional revenues such as milestone payments related to the attainment of clinical trial and commercial milestones and royalties on product sales. BioTime and BioTime subsidiaries will retain the rights to manufacture their own stem cell-based products as well as to license rights to other third parties. ESI, established in 2000 in Singapore, is distinguished as being the first company to derive and manufacture clinical-grade hES cell lines under strict regulatory standards, commonly known as current Good Manufacturing Practices (cGMP). These cell lines have been used by a number of researchers over the last seven years. ESI provides its hES cells as both inexpensive research-grade cells through its ESI BIO division and as cGMP-compliant clinical grade cells for translation into clinical applications, allowing researchers to conduct research with hES cells that can also be used in the clinic. BRICOH has established clinical cell manufacturing facilities to produce clinical grade banks of cGMP grade hES stem cells for its affiliates and collaborators, including academic and other medical research institutions or companies engaged in research and development into cell replacement therapies for the treatment of diseases addressed by the emerging field of regenerative medicine. According to Mr Jeffrey Janus, ESI's CEO and BioTime's VP of Sales and Marketing, "BioTime and ES Cell International take pride in providing ease of access to the highest quality clinical grade human embryonic stem cells to address human disease. Our partnership with BRICOH will further this goal by facilitating the availability of our cells to a wide spectrum of companies and research institutions working to develop many types of therapies. We look forward to working with BRICOH and their collaborators to further this effort."   Users of BioTime's hES cells, including those who acquire ESI hES cells through BRICOH, may need to obtain a license or other permission from Wisconsin Alumni Research Foundation or other third parties to conduct research or to make or sell any products based on the ESI hES cells.   ]]> https://biospectrumindia.com/news/97/6380/toshiba-names-a-new-director-for-the-ultrasound-business.html https://biospectrumindia.com/news/97/6380/toshiba-names-a-new-director-for-the-ultrasound-business.html Thu, 23 Apr 2015 10:58:21 +0530 Toshiba America Medical Systems has announced that Ms Maria Piazza has been named director, Ultrasound Business Unit. In her new role, Ms Piazza is responsible for developing and implementing strategic marketing plans that drive growth and profitability for the business unit. She will also work closely with the Global Business Unit at Toshiba Medical Systems Corporation (TMSC) to communicate the needs and requirements of the US market. "We are confident that Ms Piazza's leadership will continue the momentum of the Ultrasound Business Unit, which has grown significantly in recent years and continues to introduce innovative technologies like the Aplio Platinum Series," said Mr Calum Cunningham, vice-president, Marketing and Strategic Business Development, Toshiba. Prior to joining Toshiba, Ms Piazza has held many senior marketing and business leader positions. She has served in several roles including CMO, Global Advertising and Promotions director, Global Marketing Operations director and MR Global Product Marketing manager, driving strategies for product development and marketing programs across GE Healthcare's Global Businesses and Regions.   ]]> https://biospectrumindia.com/news/97/6417/regulatory-factors-limiting-us-non-vascular-stent-market-growth.html https://biospectrumindia.com/news/97/6417/regulatory-factors-limiting-us-non-vascular-stent-market-growth.html Wed, 22 Apr 2015 16:43:55 +0530 The future growth of the non-vascular stent market by 2021 will be slower in the US than almost every other major market, due in part to an increasingly difficult regulatory process and the medical device excise tax, but primarily as a result of clinical factors and unmet needs still to be addressed, says research and consulting firm GlobalData. The company's report states that the US market for non-vascular stents, which includes enteral, airway, urinal tract, and pancreatic and biliary stents, was valued at $205.5 million in 2013. It is projected to expand at a modest Compound Annual Growth Rate (CAGR) of 3.3 percent to approximately $265.8 million by 2021. By comparison, the average CAGR across the 10 major markets, namely the US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India, will be 4.5 percent, and only Italy will witness slower growth than the US over the forecast period, with a CAGR of 3.2 percent. Ms Priya Radhakrishnan, GlobalData's director of medical devices, says restraints such as pricing pressures and regulatory hurdles will continue to have an impact on this market.   She said: "Despite the regulation there still remains some growth in all the markets, primarily driven by population, rising disease prevalence and expanding indications. Additionally, the growth in the elderly segment continues to keep the CAGR positive. "On the other hand, barriers to more heightened growth in the US, as opposed to the EU, include the slower adoption of newer stent technology, due to increased regulatory scrutiny by the Food and Drug Administration and an expensive product approval cycle." GlobalData's report also states that the medical device excise tax, which is a 2.3 percent US tax on the domestic sales of medical devices paid by the manufacturer, represents a costly and immense burden. Despite this, clinical factors remain the most prominent barriers to US market expansion. Ms Radhakrishnan explained: "Factors such as a preference for minimally invasive solutions and a desire for better clinical outcomes will restrict growth. "Opportunities that need further development include more customized, biodegradable and drug-eluting stents. As the complications are addressed in the next generation of products, we can expect to see further market expansion." ]]> https://biospectrumindia.com/news/97/6758/sgs-life-sciences-mumbai-facility-witnesses-completion.html https://biospectrumindia.com/news/97/6758/sgs-life-sciences-mumbai-facility-witnesses-completion.html Wed, 22 Apr 2015 13:08:22 +0530 An official opening of this state-of-the-art laboratory is planned for May 20, 2015. The expansion has seen the previous 1,393 square meter laboratory space more than double in size to 3,400 square meters, and once validation is completed, the laboratory will act as a dedicated cGMP pharmaceutical testing site. The workforce has increased from 65 to 115, with the potential for up to another 40 employees in the additional facilities. Investment at the laboratory has been focused on increasing stability chamber capacity, and in supporting chromatography equipment, including new UPLC capabilities. The Mumbai facility now has the largest stability testing facility in the SGS Life Science Services' global network, with the expansion driven by the increased demand from both local and international customers.   The Mumbai expansion follows SGS's renovation of its Chennai, India, laboratory in 2014, increasing laboratory space within the facility. The number of employees increased from 60 to 75, with the flexibility to further accomodate up to 90. "India is strategically very important for SGS Life Science Services, and the investments we have made in both Mumbai and Chennai have been based on customer demand for dedicated Full Time Equivalent-based models," commented Mr Paul House, MD, SGS India. "These two facilities, coupled with our facility in Singapore, work very much as a harmonized unit, supporting not only local clients but those across Southeast Asia and beyond."   ]]> https://biospectrumindia.com/news/97/6257/are-mobile-medical-apps-good-for-health-.html https://biospectrumindia.com/news/97/6257/are-mobile-medical-apps-good-for-health-.html Tue, 21 Apr 2015 12:06:41 +0530 Digital data collection provider, Research Now, spoke to 500 healthcare professionals and 1,000 health app users in the UK. The survey asked healthcare professionals whether they currently use smartphone technology in their medical practice; whether they thought it was beneficial and for which types of patients; under what conditions they thought it had the greatest potential; and whether they thought that the National Health Service (NHS) should increase its investment in smartphone technology to monitor patients' health. The health app users were asked which types of apps they use and how they feel about using smartphone technology in relation to their health. Key findings: • 48 percent of healthcare professionals say that they will introduce mobile apps to their practice in the next five years.• 81 percent of healthcare professionals believe that health apps will increase their knowledge of patients' conditions.• 93 percent of users think that health apps help to improve their quality of life.• 65 percent of healthcare professionals believe that health apps will encourage patients to take more responsibility for their health.• 52 percent of UK medical professionals and 78 percent of health app users say that the NHS should increase its investment in developing smartphone technology to monitor patients' health.   Mr Simon Beedell, division director, EMEA Healthcare, Research Now, said, "Right now, only 10 percent of healthcare professionals are using mobile health apps and only 29 percent of health app users use them to monitor their health conditions. But there is a tremendous opportunity for these to transform medical care. Technology is available to allow patients with heart disease to send information about their heart rate straight to their doctors, accessories can allow diabetics to monitor their blood glucose levels and send the results straight to their smartphone, and the elderly can send information on their well-being from a simple app on a tablet or smartphone." Mr Mahiben Maruthappu, senior fellow, NHS England and co-founder of the NHS Innovation Accelerator, said, "Our ambition is to make the NHS a digital pioneer for our patients. The results of this study demonstrate the clear potential both patients and healthcare professionals see in mobile medical apps. By harnessing this technology we could transform the way care is provided." The most recent NHS Five Year Plan, released in 2014, acknowledges that it has 'an arguably larger unexploited opportunity to combine different technologies and changed ways of working in order to transform care delivery.' It also sets out that technology will play a vital role in helping contribute to the £22 billion in efficiency savings needed to sustain the NHS. The National Information Board, which is charged with developing strategic priorities for data and technology in health and care, recently produced a report which pledges that, 'In 2015, all citizens will have online access to their GP records and will be able to view copies of that data through apps and digital platforms of their choice.'   And by 2018, individuals will be able to add to their own records. Healthcare professionals (HCPs) believe that health apps will improve medical care • 81 percent believe that they will increase their knowledge of their patients' conditions.• 65 percent believe that they will encourage patients to take more responsibility for their health.• 45 percent think that they will increase the efficiency of patient treatment.• 33 percent believe that health apps will improve their relationship with their patients. Healthcare professionals see the greatest benefits for helping patients with chronic diseases • 73 percent of health professionals believe that they will help patients with chronic diseases, such as diabetes or heart disease.• 58 percent believe that they will help those who are at rising-risk of developing health issues; 49 percent believe they will help those who are healthy; and 46 percent believe they have the potential to help patients recently discharged from a hospital.   Healthcare professionals and health app users agree that the NHS should invest in health apps • 52 percent of healthcare professionals believe that the NHS should invest more money into developing health apps.• 78 percent of health app users believe that the NHS should invest more money into developing health apps. Most people use the apps as a lifestyle choice, but their use to support healthcare is growing • Most people use health apps to help them lose weight and to track their exercise (55 percent to monitor activity/workouts, 54 percent to motivate them to exercise, 45 percent to record calorie intake, and 34 percent to monitor weight loss).• However, 29 percent use the apps to monitor existing health conditions and 23 percent, to remind them to take medication.• 93 percent of health app users think that health apps help to improve their quality of life, while only 32 percent of health professionals believe that they will improve their patients' lives. Few healthcare professionals are currently using these apps, but they expect to do so in the next five years   • There is a small group of early adopters of smartphone technology in the health care profession; 10 percent already use it in their work with patients. However, 48 percent believe that they will introduce mobile health apps to their practice in the next five years.• Only 19 percent of healthcare professionals do not expect smartphone technology to become part of their work in healthcare.• 38 percent of health professionals use smartphone technology to access medical research and 38 percent expect to in the next five years.• 16 percent of mobile health app users say that they share information collected by apps with their doctors. British Heart Foundation funded Professor John Deanfield said, "Health apps have the potential to empower healthcare professionals and patients alike to identify whether individuals are at risk. It's never too early to do something about your lifetime risk and with this knowledge people can take action to protect themselves against potentially fatal conditions like cardiovascular disease." ]]> https://biospectrumindia.com/news/97/6133/sartorius-stedim-acquires-uk-based-cro.html https://biospectrumindia.com/news/97/6133/sartorius-stedim-acquires-uk-based-cro.html Tue, 21 Apr 2015 12:01:22 +0530 The privately owned company based in Glasgow, UK, has been operating in the biotechnology market since 2007, and in the last twelve months earned revenue of around 9 million euros with approximately 85 employees. The contractual parties agreed not to disclose any further details of the transaction. BioOutsource provides contract testing services to global biopharmaceutical clients in order to monitor the safety and quality of biologic drugs and vaccines. In particular, the company specializes in offering a comprehensive suite of services for the fast growing biosimilar industry. Its assays are used in the early phases of drug characterization and comparability and for lot release testing of novel therapeutics.   Mr Reinhard Vogt, member of SSB's board, commented, "By adding contract testing services, we will be able to support our biopharma clients even better in their drive to fast-track their new drug candidates through the development and clinical test phases and facilitate lot release testing in large scale manufacturing. The highly qualified team at BioOutsource will ideally complement our expertise, and we are looking forward to working with them." This acquisition will develop SSB's service offering throughout the drug development pathway. "We are delighted to have found a strong partner with a broad customer base, international reach and a powerful brand. With Sartorius Stedim Biotech we will be able to scale our business to the next level and invest in new adjacent services," said Mr Gerry MacKay, CEO, BioOutsource. "As a part of this group, we will have the opportunity to work with more international customers particularly in areas like the United States and Asia where there is significant investment in biosimilar development and manufacturing," Mr MacKay ended. ]]> https://biospectrumindia.com/news/97/6274/siemens-introduces-a-new-ultrasound-system.html https://biospectrumindia.com/news/97/6274/siemens-introduces-a-new-ultrasound-system.html Tue, 21 Apr 2015 11:54:08 +0530 The liver malfunction can be diagnosed and treated at a much earlier stage using a simple, non-invasive technique called Liver Elastography introduced by Siemens and is performed using Acoustic Radiation Forced Impulse (ARFI) imaging. ARFI is possible on Siemens' ACUSON S2000 Helx ultrasound system. The assessment provided by this technology combined with high resolution imaging, enables physicians for differentiation in abnormalities such as liver tumors, liver diseases causing cirrhosis or the quantification of fibrosis progression. Liver Elastography provides information about liver, which was earlier obtained via biopsy an invasive procedure, which is both time-consuming and stressful for the patient. This new technology is faster than conventional methods and provides comfort to the patients as well.  ACUSON S2000 system offers outstanding image clarity, semi-automated protocols, and our complete portfolio of strain imaging technologies. With the HELX Evolution, this high-density ultrasound system offers optimized probe design for streamlined workflow, Virtual Touch technologies and a full HD experience, from transducer to display.  "At Siemens, we strive to bring the most disruptive technologies to clinic; that could change the paradigms of diagnosis and management in the most difficult diseases. ACUSON S2000 HELX ultrasound system exemplifies one such innovation. It has introduced a 4th generation ARFI technology which now, with its Quantification capability, is aiding clinicians in early diagnosis of diffused liver disease. We are glad that Jaslok Hospital is utilizing this technology to its maximum," said Mr Kailash Yagnik, CEO-Clinical Products, Siemens Healthcare India. ]]> https://biospectrumindia.com/news/97/6224/thermo-fisher-introduces-new-real-time-qpcr-systems-.html https://biospectrumindia.com/news/97/6224/thermo-fisher-introduces-new-real-time-qpcr-systems-.html Mon, 20 Apr 2015 12:53:31 +0530 Thermo Fisher Scientific has introduced New real-time qPCR systems that fully integrate with cloud computing technology mark a new era in data sharing and global research collaboration. The Applied Biosystems QuantStudio 3 and QuantStudio 5 Real-Time PCR systems, designed to enable multi-institutional work across geographically dispersed teams, will be on display at the 2015 American Association for Cancer Research (AACR) Annual Meeting. The new qPCR systems are the latest addition to the QuantStudio portfolio from Thermo Fisher Scientific. Designed for low-to mid-throughput laboratories conducting real-time PCR experiments, QuantStudio 3 and 5 are the first to connect to the Thermo Fisher Cloud computing platform, allowing applied and clinical researchers to learn, analyze, share, collaborate, and obtain support within a single platform. Researchers worldwide can now collaborate online in real-time, and access their data wherever and whenever necessary. Laboratories can also share experimental conditions and results with their partners, while providing a uniform experience for every user, and helping minimize training and errors. "The QuantStudio 3 and 5 systems have been brought to market by a team with a heritage of developing the most advanced qPCR platforms. By linking technologies to a common computing platform, researchers working to control an outbreak, for example, can leverage laboratories across the world to identify virus strains from various hot zones, perform screening of the strains and monitor strain mutation in real time," said Mr Chris Linthwaite, president, Genetic Sciences at Thermo Fisher Scientific. With the Applied Biosystems QuantStudio 3 and QuantStudio 5 Real-Time PCR systems hosted on AWS, these PCR systems benefit from the inherent security of the AWS Cloud. The AWS Cloud infrastructure is architected for flexibility and security, and provides an extremely scalable, highly reliable platform that enables customers to deploy applications and data quickly and securely. Researchers using the PCR systems can access their work any time they have an Internet connection, without the need for subscription software. The new instruments seamlessly integrate with existing analysis workflows, syncing with next-generation sequencing (NGS), capillary electrophoresis (CE) and qPCR applications to create a customized data ecosystem. Interactive touch screen controls allow scientists to directly manage experiments with intuitive commands.   Applied Biosystems QuantStudio 3 and QuantStudio 5 Real-Time PCR systems are for research use only; not intended for diagnostic purposes.     ]]> https://biospectrumindia.com/news/97/7968/strands-prez-to-oversee-global-operations.html https://biospectrumindia.com/news/97/7968/strands-prez-to-oversee-global-operations.html Fri, 17 Apr 2015 16:13:53 +0530 In this new role, Storrer, who joined Strand in July 2014 as president of North America, will oversee the company's operations worldwide with a focus on strategy and business expansion. In addition, Strand introduced its US management team, which is focused on the national launch of StrandAdvantage. Available now to physicians, StrandAdvantage was designed to accelerate the analysis of therapeutically actionable cancer genes and match them to relevant FDA-approved targeted cancer therapies and open clinical trials without the need for multiple tests. Utilizing proprietary advanced analytics and interpretation expertise, StrandAdvantage provides oncologists with clinically actionable results in days instead of weeks to enable more timely decisions about the best-targeted therapies for patients. "Scott has been an integral member of the team bringing StrandAdvantage to market in the United States," said Dr Vijay Chandru, chairman & CEO, Strand Life Sciences. "The team we have appointed will support his efforts to deliver precision medicine to more oncologists and pathologists."   Mr Storrer is a 20-year healthcare industry veteran. Prior to joining Strand, he was president and CEO of Genomind, a personalized medicine company. Before this, he held several leadership positions with Cardinal Health, where he advanced to group president of Cardinal's $81 billion pharmaceutical segment. Earlier in his career, Mr Storrer was executive vice president, service and information technology with CIGNA Corp. He holds a bachelor's degree in economics and mathematics from DePauw University and an MBA. from Boston University. Mr Storrer added: "The team we are putting in place enables Strand to continue to lead advances in NGS approaches to genomic testing and to offer physicians the most advanced care options through precision medicine." ]]> https://biospectrumindia.com/news/97/7103/quintiles-ties-up-with-hospital-italiano-of-buenos-aires.html https://biospectrumindia.com/news/97/7103/quintiles-ties-up-with-hospital-italiano-of-buenos-aires.html Fri, 17 Apr 2015 10:58:24 +0530 Quintiles has announced a strategic alliance with Hospital Italiano of Buenos Aires as part of the company's Prime Site program. Hospital Italiano is Quintiles' first Prime Site in Latin America, complementing the company's robust network of investigative sites across the globe. A Prime Site is a large clinical institution selected by Quintiles to work together and enhance the institution's infrastructure for conducting clinical trials in order to accelerate the development of new and more effective medicines. Quintiles and a Prime Site work together to create a more efficient clinical trial process by recruiting, enrolling and retaining more patients through the course of a clinical trial. The new agreement with Hospital Italiano is designed to involve more patients in clinical trials than has previously been possible in one location in Latin America, increasing patient access to medications. Ultimately, this agreement will help accelerate the collection of critical data about the safety and efficacy of investigational therapies. "According to the Tufts Center for the Study of Drug Development, timelines are typically extended to nearly double their original duration to meet desired patient enrolment levels across all therapeutic areas - delays that can increase costs, deplete resources and prolong the time it takes for drugs to get to patients in need. Quintiles recognizes these challenges and is dedicated to working together differently across the healthcare system to transform drug development and achieve better patient outcomes," said Mr Jeanne Hecht, senior vice-president of site and patient networks at Quintiles. The new Prime Site at Hospital Italiano has dedicated research facilities, full-time study coordinators, a local College of American Pathologists (CAP)-accredited laboratory and full-service pharmacy. To date, Hospital Italiano has conducted more than 60 trials in 12 different therapy areas with Quintiles comparable to other Quintiles Prime Sites, and delivered the required subjects for a variety of complex trials for the company. Dr Ventura Simonovich, clinical operations coordinator at Hospital Italiano said, "Hospital Italiano is founded upon three core tenets: healthcare, education and research. We believe this agreement between Hospital Italiano and Quintiles reinforces our commitment with the community of preserving lives with passion by pursuing excellence in all three areas."         ]]> https://biospectrumindia.com/features/97/5795/volatile-raw-material-prices-pose-challenges.html https://biospectrumindia.com/features/97/5795/volatile-raw-material-prices-pose-challenges.html Thu, 16 Apr 2015 14:21:10 +0530 APAC's top performers The top performing markets in the APAC region include China, India, Japan, and South Korea. This is because Asian countries are implementing stricter infection control standards to minimize the risk of infections in healthcare facilities. "In addition, rising awareness of hygiene requirements for protection of both patients and healthcare providers are improving in these markets, which have fueled the growth of disposable medical supplies market," said an analyst at Persistence Market Research (PMR). Hot trends   Increasing numbers of minimally invasive surgeries, home care treatments, and self-monitoring activities, increasing demand for wound management supplies, rising number of mergers and acquisitions (M&As) between medical supplies manufacturers, and introduction of higher safety disposable products are the major trends observed in the disposable medical supplies industry. "Also, introduction of nitrile and latex-based gloves and increasing usage of Radiofrequency Identification (RFID) technology in disposable collection supplies are gaining momentum in APAC," PMR added. Growth drivers Increasing prevalence of chronic diseases such as mental disorders, diabetes, cardiovascular diseases (CVDs), chronic obstructive pulmonary disease (COPD) and cancer, are noted as the key driving factors for the disposable medical supplies market. Also, increasing numbers of hospitalization cases, growing aging population, improving healthcare infrastructure and rising disposable incomes are also supporting its growth.   PMR noted, "Moreover, pressures from organizations including Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Centers for Disease Control and Prevention (CDC), on implementing infection prevention standards in healthcare facilities for safety and usage purposes of medical supplies have fueled the growth of this market." Stringent regulations Analysts at PMR observed that stringent regulations for the approval of plastic-based medical supplies, and stricter disposal standards as major regulatory hurdles. Dialysis is said to be the fastest growing segment in this market. This is due to increasing prevalence of end stage renal disorders which requires high frequency of dialysis disposables for their management. "Volatile raw material prices, increasing usage of reusable items, stringent regulatory compliances for usage and disposal of disposable supplies and their environmental concerns are key challenges of the APAC disposable medical supplies market," the research firm commented.Notable innovations in 2014    In August 2014, Becton, Dickinson and Company (BD), manufacturer of medical devices and instruments, launched BD AutoShield Duo - a pen needle with a patented dual front and back-end shields, providing convenience and safety before and after injecting insulin  In August 2014, Eli Lilly, primarily involved in discovery and development of pharmaceutical products, launched Basaglar - an insulin glargine injection indicated to improve glycemic control in adults with type 2 diabetes, and in combination with mealtime insulin in adults, and pediatric patients with type 1 diabetes In October 2014, Ansell, which provides protective solutions to healthcare organizations, launched TouchNTuff 93-250 disposable gloves Key players  3M  Abbott Laboratories Advanced Medical Solutions  Bayer AG Becton, Dickinson and Company  Boston Scientific  BSN medical India C R Bard Hospira  Johnson & Johnson Kimberly-Clark  Medtronic Roche Holding  Schott AG Smiths Group  STERIS  Terumo ]]> https://biospectrumindia.com/news/97/5634/wearables-improve-walking-ability-in-ms-patients.html https://biospectrumindia.com/news/97/5634/wearables-improve-walking-ability-in-ms-patients.html Thu, 16 Apr 2015 11:31:04 +0530 PatientsLikeMe has announced the results of a novel study conducted with Biogen, that showed how people living with multiple sclerosis (MS) can use wearable activity tracking devices to collect and share their mobility data, which could potentially provide relevant information to their clinicians and to other MS patients. "MS impairs the ability to walk for many people, yet we only assess walking ability in the limited time a patient is in the doctor's office. Consumer devices can measure number of steps, distance walked, and sleep quality on a continuous basis in a person's home environment. These data could provide potentially important information to supplement office visit exam," said Dr Richard Rudick, vice-president, Value Based Medicine, Biogen. The study was designed to assess the feasibility of using a consumer wearable device to monitor activity among people with MS in a real-world setting. In it, 248 PatientsLikeMe members were provided with Fitbit One activity trackers. Of those who received them, 213 (82 percent) activated the device with the Fitbit website and authorized PatientsLikeMe to access their data. Two-hundred and three of those who authorized sharing of the data synchronized the device with the service and produced tracking data. Participants synced an average 18.21 days of data over the 21-day study (87 percent adherence). Dr Paul Wicks, vice-president of Innovation at PatientsLikeMe, said that advances in wearable health technology have the potential to shed light on disease characteristics. He added, "PatientsLikeMe is in a unique position to combine self-reported data with objective measurement and help patients and researchers learn more to impact self discovery and research." The three-week study had a lasting impact on its participants, who together took a total of 15 million steps and walked 6,820 miles, the distance from Boston to Beijing. "I got positive reinforcement to do more each day, and that really encouraged me. The Fitbit also allowed me to track what I was eating and how I was sleeping. I made more positive choices as a result," said Ms Annette Smiling, a PatientsLikeMe member and a study participant who had never used a wearable activity tracker before.   After the study period, participants were surveyed to learn more about their study experiences and about their attitudes toward technology and physical activity tracking. Of the 191 participants who responded to the post-study survey, 88 percent reported the device was easy to use and incorporate into their daily routine; 83 percent agreed that they would continue to use the device after the study; and 68 percent believed that the device would be useful to them in managing their MS. This data is being presented at the 67th American Academy of Neurology's (AAN) Annual Meeting in Washington.   ]]> https://biospectrumindia.com/interviews/97/5530/30-of-praj-revenue-comes-from-emerging-businesses.html https://biospectrumindia.com/interviews/97/5530/30-of-praj-revenue-comes-from-emerging-businesses.html Thu, 16 Apr 2015 09:03:00 +0530 A globally leading company with over 600 references in more than 60 countries across 5 continents, Praj has six key businesses. The businesses of ethanol/alcohol and brewery plants are categorized as core businesses and the recently addedverticals of water & wastewater solutions, critical process equipment and systems and solutions for pharmaceutical, biotech and hygienic applications of PrajHiPuritySystems have been categorized into Emerging Businesses.Praj has also launched its business initiatives in the bioconsumables segment. This is based on the biotech expertise and experience and the work done at Praj Matrix,the R&D Center addressing the pharmaceutical, biotech and F&B sector. Praj acquired Praj HiPurity Systems, a company engaged in providing hi purity water and hygienic systems to the pharma industry. Together with Praj Industries, Praj HiPurity Systems provides cutting edge, end-to-end solutions. This includes water treatment solutions & modular systems, wastewater treatment solutions and process engineering and design capability to ensure superior level of service to clients in these sectors. How big is the HiPurity business today? I understand that this group falls in the "Growth Business" trajectory of Praj and this business would account for nearly 30 percent share of the total revenues of Praj.The Emerging businesses form 30 percent of Praj revenues. The contribution of PrajHiPurity to the revenue is significant. In fact, the investments in pharma machinery would probably lead pharma industry growth. Neela Systems has been providing integrated solutions in water treatment and process development. Can you outline its vision, key business strategies, and market reach?Reducing time to market for our clients by bringing to India the prevalent practices of developed markets like EPC (Engineering, Procurement and Construction) while setting up new Pharma facilities in India. More and more clients want faster plant installation with single point responsibility including water and process systems. A few of our multinational clients have NMT 5-6 key agencies delivering an entire facility. While in India, there are an average 300 agencies delivering an entire plant In India. We were in strategic position to deliver such solutions as a single point responsibility for Water and Liquid Processing skids/ systems. There are very few companies around the globe with such skill sets to deliver water and process solutions together. Our previous engagements with the pharma industry has helped us get valuable insights on the actual functioning of a pharmaceutical project, its needs, its drivers, its constraints and thereby helping us design more robust and user friendly solutions. We believe more than half of the clients operating in the Biopharma and Sterile injectables space will look for a single point Integrated solutions for water and liquid process systems. Add to that our capabilities to handle their waste water requirements, we are a in a perfect position to lead this space.What is the current stake of Praj in the subsidiary?Praj holds 80 percent stake in PrajHiPurity Systems. The company recently announced the launch of BioWiz Smart Bioreactor. Could you explain us the innovation behind this product?Biowiz Bioreactor / Fermenter series is designed to cater to the fermentation applications in Biopharma and other related industries. These products have beendesigned with exhaustive insights of actual end users. Handling these bio-reactors are going to be a different experience for the end user with a fresh perspective. Theuser friendliness of the systems will be visible to one and all handling the system and in the end prove to be a great shift from conventional systems. These new generationBioreactors/ Fermenters will be available in a variety of options keeping in mind their application, objectives and resources available. Clients would be able to make a more informed decision while selecting the type of system. Largely the system is designed for delivering 'plug and play'. The system design is a good blend of classical protocols and Information Technology in the most efficient way. Some features have been arrived upon by collective experience of a few hundred years and a year full of man day efforts with 5 disciplines of science and engineering working in cohesion. We sincerely believe a product built with such care and passion will challenge and change the status quo in the industry for re-usable Bioreactor/ Fermenter space.Does this also signal the extension of HiPurity's solutions portfolio into other areas?Yes. It announces the arrival of PHS as a player in this space with the uniqueness enjoyed by a very few organizations across the globe in the EPC space for the Bio-pharmaceutical Industries. PHS by virtue of Biowiz in its portfolio can truly pose as a one stop solution provider for Bio-pharmaceutical Companies. This would be a big shift from its present portfolio catering to Clean utilities and Unit liquid Processes to a truly 'one-stopshop'. PHS has added feathers in the cap by executing some of the prestigious projects in European market currently with CE certification. PHS has planned to introduce/showcase the capabilities at appropriate platform in coming future. What are your other important product pipelines?PHS is also working to develop skids for Tangential flow filtrations (TFF) to cater the Bio pharma requirements. Apart from these, we have a few more products in pipeline in the water treatment phase with the prime objective of eliminating multiple unit processes (7-8) that our clients employ for treating water. We intend to have NMT 5 unit processes to deliver Purified water from any grade of feed water. Handling pathogens in raw water has been a consistent problem and the industry has notyet received any solutions. We are in process of developing an application for the purpose of delivering pathogen free water to the water treatment plant. This will change the fear perception that follows with water treatment and its related challenges (treatment and Validation). You should hear of these product roll-outs shortly.   ]]> https://biospectrumindia.com/news/97/5251/samsung-unveils-new-healthcare-products.html https://biospectrumindia.com/news/97/5251/samsung-unveils-new-healthcare-products.html Wed, 15 Apr 2015 11:11:31 +0530 Samsung Electronics America, a subsidiary of Samsung Electronics has reinforced its commitment to help healthcare providers enhance patient care, improve patient satisfaction and increase workflow efficiency with its lineup of products at the HIMSS Annual Conference and Exhibition. The company is demonstrating its range of products and solutions in specific healthcare scenarios. "Samsung has a continued commitment to the healthcare sector as part of our enterprise focus and we are excited that HIMSS provides an opportunity to show the breadth of our products and solutions to provide better connected care," said Mr Ted Brodheim, vice-president of vertical business at Samsung Electronics America. "We want to demonstrate that Samsung understands the need to improve healthcare outcomes while lowering costs, and we will be their partner in transforming the provider and patient experience." Samsung's leading technology has applications across the spectrum of healthcare settings, from lobbies and patient registration areas to exam rooms and call centers. The booth features Samsung's connected care experience for visitors to learn how its technology solutions work together in real-life scenarios, including Lobby/Patient Registration, Exam Room, Remote Care Management and Smart Patient Room. Also integrated through Samsung's technology showcase is Samsung KNOX - its best-in-class secure enterprise mobile platform. Samsung KNOX provides comprehensive data protection and powerful device management capabilities that are critical when it comes to storing patient information and medical records.   ]]> https://biospectrumindia.com/news/97/5209/medtronic-announces-ce-mark-approval-for-micra-pacemaker.html https://biospectrumindia.com/news/97/5209/medtronic-announces-ce-mark-approval-for-micra-pacemaker.html Wed, 15 Apr 2015 10:40:36 +0530 Medtronic has announced that it has received the CE (Conformité Européenne) Mark for the Micra Transcatheter Pacing System (TPS), the world's smallest pacemaker. At less than one-tenth the size of a traditional pacemaker, the Micra pacing system provides the most advanced pacing technology available while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart. Comparable in size to a large vitamin, the Micra TPS does not require the use of wires, known as "leads," to deliver pacing therapy; rather, it is attached to the heart via small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Once positioned, the Micra TPS is attached to the heart wall and can be repositioned or retrieved, if needed. The device responds to patients' activity levels by automatically adjusting therapy. Despite its miniaturized size, the Micra TPS has an estimated 10-year battery life and is approved for full body MRI scans, providing patients with access to the most advanced imaging diagnostic procedures. The device was awarded CE Mark based on results from the first 60 patients (at three months) in the Medtronic Micra TPS Global Clinical Trial. The trial is ongoing and will continue to evaluate the safety and efficacy of the device through a single-arm, multi-center study that will enroll up to 780 patients at approximately 50 centers in 20 countries. Initial results from the Micra TPS Global Clinical Trial will be revealed for the first time at a late-breaking clinical trials session at the Heart Rhythm Society's 2015 Annual Scientific Sessions in May.   In the US, the Micra TPS is an investigational device and not yet approved for commercial use. "Our cross-functional teams have been working for years to redefine engineering limits and production capabilities by radically reducing the size of medical devices by more than 90 percent while continuing to innovate upon the existing technology. We believe our investment in this research is transforming cardiac care and will provide more and better therapy options to patients," said Dr Brian Urke, vice-president and general manager of the Cardiac Rhythm and Heart Failure's Brady business, which is part of the Cardiac and Vascular Group at Medtronic.       ]]> https://biospectrumindia.com/features/97/8300/we-need-right-people-at-the-right-place-industry.html https://biospectrumindia.com/features/97/8300/we-need-right-people-at-the-right-place-industry.html Tue, 14 Apr 2015 14:17:00 +0530 The event witnessed more than 35 participants from various top organizations and positions including CEOs, budding startup entrepreneurs, investors, policy makers and directors.In the back drop of the recent budget execution by Finance Minister Arun Jaitley in February 2015, the conclave opened wide doors for an engaging and stimulating discussion on the impact of the budget on the industry. Hosted by Mr Narayanan Suresh, group editor, BioSpectrum India & Asia, the forum offered a open setting for participants to express their view point, expectations, concerns and issues impacting the industry. Issues relating to tax payments and incentives, SME growth, innovation insurance, funding, government-industry collaboration, and clinical research dominated the discussion forum. Dr Mahadevappa, director, JSS Rural Development Foundation, opined, "It is a critical time that the government should come forward and exploit the potential. There are opportunities where without spending money farmers can derive benefits." Ecron Acunova's chairman, Mr D A Prasanna pointed that one of the major hurdles to 'Make in India' is the unsynchronized coordination between the Department of Pharmaceuticals, Department of Biotechnology and Department of Health.   "Each department is trying to optimize their own objective instead of coming together and solving issues," he added. He suggested that a group or a forum between the secretaries of Pharmaceuticals, Biotechnology and Healthcare should ensure that issues are taken forward especially in clinical research. "Research has to be conducted in hospitals. Drug approvals take prolonged timeline and then there are issues of drug pricing. The faster we are able to bring together multiple departments, the more positive effects will be seen in bringing new drugs and innovations to the market," he explained. Mr Prasanna was seen to be optimistic about the speed of application processing by regulators. "What is very positive is that the speed of processing applications by the regulators has seen a major improvement, and the changes made by the new government is very encouraging. We welcome this move and will see to it that it continues," he shared. "In terms of schemes and opportunities, they are available in plenty," commented Mr Naveen Kulkarni, CEO and founder, Polyclone Bioservice. He felt that there is a missing link between different departments. "A group, division or a department, especially the state government, can take the lead and say that here is the scheme and this is how we will go about it. From the funding point of view, we have a lot. Execution and implementation takes time. The question is, having the right people at the right place. The government should now start thinking in terms of people," Mr Kulkarni held. Dr B V Ravi Kumar, founder and CMD, XCyton Diagnostics, said that one of the biggest hurdles in research is making it academic centric. "We need to have right people at the right place. At times there are schemes people don't understand or how it works. As a nation the general public is not for innovation. It is only willing to judge innovative companies versus non-innovative companies. I'm not even dreaming about innovation insurance. We should not be pushed through mechanisms that are not well understood," he expressed. Dr Ravi also said that the government doesn't want to know the industry's problems. "Budget only gives you a framework. What is hurting is that there was no mention about what is happening in the science and technology (S&T) area. Budget cuts on S&T will have a devastating effect on the industry. We should first innovate in India and then make it in India," he concluded. Mr R Raghu, VP, Schrödinger, spoke in terms of investing in R&D in India. "In our country, there are many MNC pharma companies selling products and making millions. How much are they investing back in R&D in India? How many are setting up their R&D centres in our country? Sadly, they are vanishing. If this continues, in a few years from now India will not have any R&D happening," he lamented. "If biopharmaceutical MNC companies are selling products in India, and if their turnover is about $100 million, then they should spend at least $5 million towards R&D in India, which should be exempted from all taxes," he recommended. "Secondly, the government including DBT and CSIR are cutting finances in academics. On one hand innovation has to be developed, and on the other we have to spend money to innovate in R&D," said Mr Raghu. In China, R&D spend has increased and they are pumping more, he pointed. "In India, higher education and research has to be developed. When an academic institute is offered funding beyond Rs 5 crore, then it should be in collaboration with the industry, because there are big lacunae between them. It is crucial to bring in the industrial partners," he highlighted. Bangalore-based entrepreneur, Ms Monisha Hajra, founder, ScientiaBio, noted, "We generate more income from Singapore and Malaysia than from India. Most of our clients there hail from the government sector. All it takes is just one email to get the job done. It is easy for service companies to leverage on startup space, but what about diagnostics and project-based companies?" Many participants also emphasized on the funding woes faced while presenting the research proposal to committees. "The timing of the funding is significant. The bottleneck is that we don't have the right people in the right place. We need someone who understands commercialization and scaling up process. If we want innovation to happen, then the timing of the funding is very important. Also there is lack of clarity. Startups need a clarity on how regulations and funding work. This would help them get their funding at the right time. We need to address this if we are going to make the 'Make in India' campaign a stunning success," remarked Ms Ezhil Subbian, CTO, String Bio, another Bangalore-based startup. Mr Pradeep Karatgi, cofounder and director, IDRS Labs, said that getting the right license is an extremely time consuming process. "In Europe and the US, for example, there is always a streamlined process having specific timeline. In India marketing authorization takes 3 to 4 months, and at times even 30 months," he expressed. Mr B N Manohar, MD, Stempeutics, mentioned in terms of tax holidays and PM's support towards stemcells. "The government is willing to work with the industry to form a regulatory frame work. They are moving away from paper-based system to electronic system. In the last one year, I see a positive change in the speed with which things are processed. Whether it is about clinical trial approval or funding, if you have your proposal, they will act much faster. Another positive aspect is the supporting of innovation. Soon they are planning to adopt the Japanese framework. Over all, it is happening and there is a feel-good factor. The government should focus on tax reforms and nurture innovation. The 100 percent FDI for medical devices is commendable," he explained. Mr Manjunath Devaramani, R&D head, Denovo Biolabs, a new startup at IBAB, commented on product pricing and competency. "We have our own challenges. We develop our products and compete with major players inside and outside India. To be competent we need to be competent in quality at lower prices. But we have to pay sales and services taxes and corporate taxes. How do we keep the costs lower when taxes are so high? There must be a system, at least for startups, offering benefits like tax slabs," he said. Mr Bhavik Kumar, cofounder of the four-month old Bangalore startup, Medibox, supported the PM Modi's Swach Bharat, Make in India and Digital India campaigns. "Investments are going to be huge in digital healthcare in accordance with our PM's campaign, and it can run well on it," he revealed. Dr Arumugam Muruganandam, founder, MD & CSO, Affigenix, suggested that the government should operate like VCs when it comes to funding. "The VCs have consulting in every field. The government, on similar lines, has consulted experts in the industry in certain cases while dealing with bigger grants. It has to continue this by operating like VCs, where they approach experts, evaluate and manage the money," he advised. Dr Jagadish Mittur, head, Biotechnology Facilitation Cell (BTFS) at KBITS, emphasized on industry experts working alongside with the government for the betterment of the existing system. "We got to be practical. We have to work on the existing system because it seems to be sloppy. How many people are willing to come and work in the government sector? Scientific professionals can become 'Scientocrats' and academicians can volunteer to work and improve the system. We should not underestimate the competence of people who hail from academics. We must work on aligning the State's biotechnology framework with the national framework," he impressed. He feels that the government is interested in creating more and more innovation clusters to create an environment that is entrepreneurial. "The future is going to be bright for Karnataka. Now, what is missing is the upliftment of agriculture sector. There are many drought stricken districts in Karnataka. And water availability seems to be the biggest problem. The Central government should spend its budget to address the water scarcity. Unless this is addressed, it is going to be very difficult to see any progress in the agri sector, and consequently this is going to affect our country drastically," Dr Mittur added. "The sentiments of the industry and the government needs to be synchronized. The budget allocations aren't very clear," stressed Mr Veerbhadra Yadwad, product manager, environmental and analytical group, Yokogawa India. Dr Binay Panda, chief officer and head, Ganit Labs, voiced that people on research proposal judging committee do not understand commercialization. "We do not even have the right or enough people who can judge a research proposal. Ninety-nine percent of the people who sit on judging committees are purely from academics and do not have any idea or experience about commercialization aspects," he added. "The amount of money we have should be distributed efficiently by improving the existing system. We should work together in helping the government improve the system and getting the money in the hands of people, rather than complain about what the government is not doing," Dr Panda mentioned. Mr Suresh Ramu, cofounder & CEO, Cytespace, commented on the origin of innovation and nurturing it to the fullest. "There is enough talent and risk-taking appetite. One cannot support large organizations and expect innovation. Innovations can also come from smaller companies. They need to be developed and promoted. In a global setting, we cannot bring in regulations and say that foreign drug molecules cannot be authorized to carry out research. We cannot blanket research. On the healthcare side, spending 2 percent of GDP is fantastic, but it is not enough. The government needs to create a framework. Healthcare incentives and import duties needs to be taken care. Increasing import duties will enable local manufacturers to compete," he held. ]]> https://biospectrumindia.com/news/97/5153/ibm-and-partners-to-transform-personal-health-with-watson-and-open-cloud.html https://biospectrumindia.com/news/97/5153/ibm-and-partners-to-transform-personal-health-with-watson-and-open-cloud.html Tue, 14 Apr 2015 11:50:00 +0530 To dramatically advance the quality and effectiveness of personal healthcare, IBM is establishing a Watson Health Cloud that will provide a secure and open platform for physicians, researchers, insurers and companies focused on health and wellness solutions. The HIPAA-enabled Watson Health Cloud will enable secure access to individualized insights and a more complete picture of the many factors that can affect people's health. Extending the company's exclusive Watson cognitive computing platform, IBM is Entering new partnerships with leading companies including Apple, Johnson & Johnson and Medtronic to help optimize consumer and medical devices for data collection, analysis and feedback. It is also acquiring Explorys and Phytel to advance its healthcare analytics capabilities. And also, establishing a dedicated business unit - IBM Watson Health, to be headquartered in the Boston, MA, area. "All this data can be overwhelming for providers and patients alike, but it also presents an unprecedented opportunity to transform the ways in which we manage our health," said Mr John E Kelly III, IBM senior vice-president, solutions portfolio and research. He added, "We need better ways to tap into and analyze all of this information in real-time to benefit patients and to improve wellness globally. Only IBM has the advanced cognitive capabilities of Watson and can pull together the vast ecosystem of partners, practitioners and researchers needed to drive change, as well as to provide the open, secure and scalable platform needed to make it all possible." IBM is collaborating with Apple, Johnson & Johnson and Medtronic to create new health-based offerings that leverage information collected from personal health, medical and fitness devices. The results will be better insights, real-time feedback and recommendations to improve everything from personal health and wellness to acute and chronic care. These relationships are non-exclusive, and IBM anticipates many more companies to leverage the Watson Health Cloud platform. IBM and Apple will expand their partnership with IBM Watson Health Cloud to provide a secure cloud platform and analytics for Apple's HealthKit and ResearchKit. This will support health data entered by customers in iOS apps and also arm medical researchers with a secure, open data storage solution with access to IBM's most sophisticated data analytics capabilities   Johnson & Johnson will help create intelligent coaching systems centered on preoperative and postoperative patient care, including joint replacement and spinal surgery. Solutions will be mobile-based, accessing the Watson Health Cloud and leveraging IBM Watson's cognitive capabilities. It will also look to launch new health apps targeting chronic conditions, which currently cost consumers as much as 80 percent of the $7 trillion global healthcare spend. Medtronic will leverage the Watson Health Cloud insights platform to deliver new highly-personalized care management solutions for people with diabetes. The solutions will receive and analyze patient information and data from various Medtronic devices including insulin pumps and continuous glucose monitors, and use this information to provide dynamic, personalized diabetes management strategies to patients and their providers. To complement its existing capabilities, IBM has reached an agreement to acquire Cleveland-based Explorys and Dallas-based Phytel, two healthcare technology companies that are widely recognized for their leadership in applying Big Data and analytics to help improve the quality of health for individuals and large population groups. The acquisitions bolster IBM's efforts to apply advanced analytics and cognitive computing to help primary care providers, large hospital systems and physician networks improve healthcare quality and effect healthier patient outcomes.       ]]> https://biospectrumindia.com/news/97/6253/shimadzu-partners-with-tokyo-electron-.html https://biospectrumindia.com/news/97/6253/shimadzu-partners-with-tokyo-electron-.html Tue, 14 Apr 2015 10:57:06 +0530 Shimadzu has announced that it has been participating in a Japan-UK industry-academia-government project led by Tokyo Electron, aimed at developing technologies for automatic cell cultivation and inspection processes ("Smart Cell Processing Project"), in which its cell analysis method is utilized. The cell analysis method, developed by the company, allows simultaneous analysis of the 95 components contained in pluripotent stem cell culture solutions in only 17 minutes, using a high-performance liquid chromatograph-mass spectrometer. With this method, Shimadzu is contributing to the establishment of quality control technology for pluripotent stem cells. The development of this method indicates Shimadzu's full entry into the cell analysis business. In its medium-term management plan (for FY 2014 through FY 2016), Shimadzu has identified lifescience innovation as one of its key business strategies, and has been focusing especially on cell (iPS, ES cells, etc.) analysis business. This method has already been commercialized and Shimadzu is now releasing the LC/MS/MS method package Cell Culture Profiling. This product allows simultaneous analysis of a wide range of components contained in culture media, including trace components, such as vitamins and polyamines, and components contained in high concentrations, such as glucose and glutamine, using the same vial.   Tokyo Electron has been promoting the Smart Cell Processing Project, which aims at establishing and standardizing technology for smart cell processing for cultivating high-quality stem cells, applying Tokyo Electron's existing cleaning and processing technologies. This project involves 15 partner companies having various technologies.     ]]> https://biospectrumindia.com/features/97/8242/toilet-revolution-solving-indias-sanitation-problem.html https://biospectrumindia.com/features/97/8242/toilet-revolution-solving-indias-sanitation-problem.html Sun, 12 Apr 2015 09:14:00 +0530 UNICEF reports that close to 600 million people in India defecate in the open. "India leads the world in open defecation. This crisis contributes to disease, childhood malnutrition, loss of economic output and, as highlighted recently, violence against women," said Mr Vinoth Rayar, founder and president, Fresh rooms Lifesciences.The government spends quite a huge amount on rectifying ailments resulting from improper sanitation. With PM's "Swach Bharat Abhiyan" and "Reinvent the Toilet Challenge (RTTC)" jointly conducted by DBT, BIRAC, and Bill & Melinda Gates foundation, India is addressing its neglected public sanitation problem. We take a look at the innovative approaches and technologies that can lead to radical and sustainable improvement in sanitation in India.The ChallengesCreating sanitary infrastructure and public services that work and keep waste out of the environment is a major challenge. Lack of awareness about the importance of a household toilet is also a roadblock. The absence of a toilet necessitates open defecation in rural areas and in outlying and neglected urban areas.Unclean and deserted toilets pose another risk. "Our key learnings and findings based on our 6 plus years' of experience in this sector, reveal the underlying challenges associated with poor, unclean and improperly maintained toilets in the country. Toilets are sufficient in numbers but the number found to be in proper, hygienic and functioning conditions are scarce, subsequently scaling up the demand for constructing new toilets," said Mr Anvar Sadath, CEO, Eram Scientific Solutions (ESS). "One of the major problems and associated costs involved with sanitation or toilet technology is the safe disposal of human waste. In a majority of cases, waste is discharged into large water bodies which subsequently results in the spread of enteric infections, which cause diarrhea, cholera and others resulting causing a huge health burden in developing countries. Although convenient physicochemical methods of disinfection can be applied, these technologies are not in the affordable range for developing or poorer nations," said Dr Sanjay Pal, assistant professor at the School of Biotechnology, Amrita University.Solving the sanitation challenge in the developing world requires radical new innovations that are deployable on a large scale. "The most critical issue that the sanitation sector faces is the lack of systems-based thinking. We need to go beyond simply providing a toilet," opined Mr Rayar.Solving the sanitation problem1. Empowered Septic Tank (EST)Sustainable Biosolutions LLP, a BITS Goa incubated startup has proposed an Empowered Septic Tank (EST). "The objective is to construct an EST. The system is based on Bio-electrolysis of wastewater which will exhibit an activated biogas (H2+ CH4) production combined with a higher retention of ammonium which could be potential fertilizer. The effluent of the EST thus will have a lower load in COD and a lower odor. The prototype will be available within the next two years," said Dr Srikanth Mutnuri, associate professor, BITS Goa campus and technical collaborator for Sustainable Biosolutions.   The project which is funded by DBT, BIRAC and Bill & Mellinda Gates foundation is in collaboration with Ghent University, Belgium and BITS, Goa campus.2. Black Soldier Fly Larvae (BSFL) Indian Institute of Technology Roorkee (IIT-R) in collaboration with Fresh rooms Life Sciences are working on developing a single household container that will cultivate Black Soldier Fly larvae, using human faeces, which can be processed into valuable products. The project will also demonstrate the market potential for these products. This is a proof of concept grant.Mr Rayar elaborated, "Fresh rooms lifesciences in association with IIT-R is developing an eco-friendly sanitation solution that exploits the natural capabilities of the Black Soldier Fly Larvae (BSFL), to efficiently process organic waste and ends, ideally, with safe usable commercial byproducts such as animal feed, biodiesel, and fertilizer. Our fundamental principle in the technology is that we visualize human excreta and wastewaters as not waste, but a valuable commercial resource that can be reused and recycled." He further added, "Our vision is to make human excreta a profitable nutrient-rich raw material from which we are able to industrially collect waste and produce a high protein BSFL meal (a fish meal alternative) on a larger scale." 3. Bacteriophage therapyBacteriophage therapy against bacterial infections is a technology that has been applied and adopted by Russia and Eastern Europe over the past several decades. "This is now being explored with a new perspective to combat the threat of 'superbugs' which are resistant to a wide range of antibiotics. Hence, as a project initiated by two senior faculty members at the Amrita School of Biotechnology, Drs Sanjay Pal and Ajith Madhavan, we took up the idea of solving improper sanitation associated health risks by developing lytic agents /viruses against human enteric pathogens and parasites," said Dr Pal.The project is selected for the DBT-BIRAC-BMGF Grand Challenge Award, the work being carried out is well on its way to establishing the Proof-of- Concept. According to Dr Pal, preliminary results have shown very encouraging results with up to 90 percent reduction in microbial flora from sewage. Strategies to tackle helminth and protozoa pathogens are also being designed. "The impetus for us to pursue this work on affordable and effective solutions to the sanitation needs in India," mentioned Dr Pal.4. Water-free toiletScientists at the Institute of Chemical Technology, Mumbai (ICT) are evaluating the concept of using fine sand-like material and an air blower to create a water-free toilet interface that is free from odour and flies. "In the project, we propose a toilet that requires no water for flushing and is self-cleaning, therefore it can also decrease the spread of diseases. Toilet uses an unique mechanism to convey faecal matter away from the user replacing traditional water based mechanism, The quantity of faecal matter is in the order of 500g and almost 5-10 litres of water is used for flushing greatly increasing the volume of waste to be treated. The toilet mechanism we propose has potential to greatly decrease the amount of waste to be treated further reducing costs. The mechanism is such that the user is always presented with a clean interface, removing another hindrance to the use of the toilets. There is immediate isolation of human waste from flies and other vectors and surface waters, and there is no need of plumbing infrastructure; hence can implement on a mass scale in poorly serviced urban communities," said Dr Parag R Nemade, UGC Assistant Professor in Engineering Science, Department of Chemical Engineering and Department of Oils, Oleo chemicals and Surfactant Technology, ICT, Mumbai. The approximate targeted cost per use is < 20 paise. The concept is the winner of RTTC challenge.5. Ultrasound for sanitationBangalore-based Pradin technologies has come up with a concept of using ultra-sound to reduce water usage in a toilet. It will also test the ability to enhance the settling of faecal particles in a storage tank using ultra-sound."In phase-1 we are focusing on reducing wash water use & accelerating the settling time of waste by the use of ultrasound in the new toilet seat design & the waste settling tank. This is a proof of concept experiment to freeze on the process parameters. . The use of ultrasound is brought to converge in this application maybe for the first time. There will be few iterations before we deem it ready for commercial use. The system has to be finally a self-sustaining one without connections to the grid or the main sewerage lines," said Dr Dinesh Bindiganavale, founder director at Pradin technologies.The project is in the beginning stage of the concept and the researchers believe they will get promising results by end 2015. The project is funded by DBT, BIRAC and Bill &Melinda Gates foundation.6. EToiletsESS has developed an eToilet (Patent Pending). These are built of Stainless Steel or Mild Steel enclosures and have electronic systems for enhancing user experience and for tracking the health status of eToilets. EToilets have automated access control systems, sensor enabled water minimization, and self-washing and floor wash mechanisms. These eToilets have simple user interfaces and has integrated a comprehensive maintenance plan which ensures that the eToilets are clean and hygienic for every user. The eToilet has a facility of pre-flushing before entering, automatic flushing once usage is done, in-built water tanks, sensors for water and electricity conservation, automatic platform cleaning and power back-up with coin operated entry. Keeping in mind individual needs these toilets are programmed to flush 1.5 litres of water after three minutes of usage or 4.5 litres if usage is longer. The performance status of the units can also be monitored via web using GPRS connectivity of the units.Solar powered toilets: In addition to these, ESS has also introduced solar powered, self-cleaning eToilet, with inbuilt solar panel and metallic platform for schools. The model called e-Lite14 eToilet for schools has automated self-cleaning and washing mechanisms and automatic floor wash system, automatic ceiling light, in-built sensors to conserve electricity and water and an overhead water tank. The company has installed 600+ of these toilets in more than 13 states in India covering whole of Kerala, Tamil Nadu, Karnataka, New Delhi, Himachal Pradesh, Nagpur, Haryana, etc."These eToilet has been recognized by over 34 + National and international awards. Eram has also been awarded the World's Most Innovative Companies- India List 2014 by US-based Fast Company's Annual Most Innovative Companies issue," said Mr Sadath.  ESS is also the recipient of RTTC grant. 7. BiodigestorDRDO has developed Biodigester technology for resolving the problems of un-decomposed human waste. The innovation degrades and converts the human waste into usable water and gasses in an eco-friendly manner. The generated gas can be utilized for energy/ cooking and water for irrigation purposes. The process involves the bacteria which feed upon the faecal matter inside the tank, through anaerobic process which finally degrades the matter and releases methane gas that can be used for cooking, along with the treated water. The Bio-digester tank can be manufactured and customised as per the requirement.DRDO has installed these bio-toilets for army in high altitude locations. Under a Memorandum of Understanding (MoU) with Railways, it planned to install these biodigestor in all trains in the years to come. DRDO has contributed this technology to "Swach Bharat Abhiyan".Organizations supporting sanitationSulabh foundation has developed an environmental friendly two-pit, pour-flush compost toilet known as Sulabh Shauchalaya which is affordable and does not require scavengers to clean the pits. The toilet has been implemented in more than 1.2 million houses all over India, according to the company website.Wockhardt foundation has launched "bio toilet programs" and installed these toilets at various places like one in Bharat Nagar (Bandra-East), Mumbai.RICE is a nonprofit research organization which initiate and build relationships with policy makers to advocate policy goals and report research findings related to child health including links with sanitation, nutrition, and maternal health; contribute to the design and execution of research and policy advocacy projects. These evolving technologies thus can play a pivotal role in the area of sanitation and can help overcome the issue of open defecation, which is rampant in India. ]]> https://biospectrumindia.com/news/97/6566/quintiles-wins-best-cro-award-at-world-vaccine-congress-2015.html https://biospectrumindia.com/news/97/6566/quintiles-wins-best-cro-award-at-world-vaccine-congress-2015.html Fri, 10 Apr 2015 15:12:03 +0530 After being named as one of America's best employers by Forbes, Quintiles, for the third time in the last four years has been named the best clinical research organization (CRO) at the Vaccine Industry Excellence (ViE) Awards. Presented at the World Vaccine Congress in Washington DC, the awards recognize the efforts and achievements of companies and individuals in the vaccine industry during the previous year. "We are honored to once again receive this prestigious award reflecting the insight of many from across the biopharmaceutical industry," said Mr Phil Breitfeld, vice president & head, Therapeutic Centers of Excellence, Quintiles. "It is clear to us all that the healthcare industry has a tremendous opportunity to conquer the global burden of disease. We're proud to be working alongside our customers to develop and commercialize vaccines and anti-infective products that contribute to those efforts and can help create a healthier world." The award winner is selected by leaders from biopharmaceutical companies and other industry experts who vote online for their preferred provider prior to the World Vaccine Congress. ]]> https://biospectrumindia.com/news/97/4282/iba-and-toshiba-sign-pact-for-particle-therapy.html https://biospectrumindia.com/news/97/4282/iba-and-toshiba-sign-pact-for-particle-therapy.html Fri, 10 Apr 2015 12:20:23 +0530 IBA (Ion Beam Applications)and Toshiba Corporation has announced the signing of a global collaboration to expand access to advanced particle therapy worldwide. Toshiba Medical Systems Corporation will become the distributor in Japan for ProteusONE, IBA's compact single-room proton therapy solution, and IBA will become the agent for Toshiba's Carbon Therapy Solutions outside Japan. IBA and Toshiba will collaborate on activities such as customer education for ProteusONE and Toshiba's carbon therapy solutions. The collaboration will also enable both organizations to mutually leverage their Operation and Maintenance (O&M) services. Mr Olivier Legrain, chief executive officer of IBA said, "This is an important step for IBA. A closer collaboration with a company of Toshiba's caliber and leadership will accelerate the expansion of proton therapy in Japan and the introduction of Toshiba's carbon therapy across the world. Carbon ion therapy is particularly suitable for treating radio-resistant tumors and allows for dose escalation, which is recommended in a number of clinical applications. Through this new collaboration, IBA will further strengthen its world leading position in proton therapy and will reaffirm its leading position in the delivery of the latest innovative cancer therapies worldwide." Mr Satoshi Tsunakawa, chief executive officer of Healthcare Company, Toshiba Corporation, said, "Proton and carbon therapies are among the most exciting technological advancements in the treatment of cancer. Toshiba looks forward to collaborating with IBA to enhance access to best-in-class technologies for both proton and carbon therapy centers. This collaboration will give both our companies an enhanced set of tools to provide the best cancer treatment technologies."   Proton Therapy is considered an advanced and targeted cancer radiotherapy treatment due to its superior dose distribution and fewer side effects. Carbon ions not only have similar physical characteristics as protons, they have also a higher radiobiological effect compared to photon and proton, which could lead to shorter treatment courses and improved patient outcomes.   ]]> https://biospectrumindia.com/news/97/6780/make-in-india-galore-at-philips-healthcare-.html https://biospectrumindia.com/news/97/6780/make-in-india-galore-at-philips-healthcare-.html Thu, 09 Apr 2015 16:15:49 +0530 Both the products have been developed for India and other global geographies. Other healthcare innovations including Allura Centron, and PrimaryDiagnost, have also been innovated in India and are manufactured at HIC's Pune facility. As part of its global strategy, HIC will function as a healthcare innovation and manufacturing hub for India and international markets. Designed and developed by a team of 25 engineers at HIC, MobileDiagnost Opta is an innovative digital X-ray system that helps radiologists with consistent diagnostic image quality with mobility and ease of use in restricted places like Intensive Care Units (ICU) and Operation Theatres (OT). "We have our manufacturing, R&D and commercial headquarters in India. We have the highest focus on healthcare, and it gets sharper and sharper. It is about addressing challenges that countries and patients face. For us innovation starts with patients. That's the heart of everything we do. We do local manufacturing, simultaneously focusing on global markets reaching multiple geographies," said Ms Rekha Ranganathan, global general manager, mobile surgery & head, Philips Healthcare Innovation Center.   The mobile surgery system BV Vectra mobile C-arm system is intuitive to operate and is dedicated to orthopedic surgical procedures, including trauma, spine and pain management. The system, developed by a team of 45 engineers is perfect for visualizing difficult spinal or comminuted fractures. Philips' healthcare segment occupies 40 percent, followed by its lighting business at 34 percent and consumer lifestyle at 26 percent. HIC is Philips' only such center in emerging markets, said the company in a press statement. The center was inaugurated in 2012. In the last 2-3 years, the center has filed 4 patents, and 36 disclosures.   We are not just manufacturing in India, but we do our R&D and manufacture products for India as well as global markets in more than 90 countries. This is a real testament to 'Make in India' campaign," commented Mr Sameer Garde, president, Philips Healthcare, South Asia. In 2014, Philips invested approximately 8 percent of sales in R&D globally. ]]> https://biospectrumindia.com/news/97/4123/vc-funding-in-healthcare-it-dips-in-q1-report.html https://biospectrumindia.com/news/97/4123/vc-funding-in-healthcare-it-dips-in-q1-report.html Thu, 09 Apr 2015 09:30:00 +0530 Venture capital (VC) funding in the Health IT / Digital Health sector across the globe has dropped by about 35 percent, coming in at $784 million in 142 deals compared to $1.2 billion in 134 deals in Q4 2014, says a report by Mercom Capital Group. Announced debt and public market financings in the sector amounted to $975 million in seven deals in Q1 2015 including one IPO, bringing the total corporate funding raised in the sector for Q1 2015, to almost $1.8 billion. Health IT / Digital Health companies have now raised almost $10 billion in VC funding since 2010, the report stated. "Funding fell across the board with the exception of Mobile Health (mHealth), which was the bright spot this quarter. There was also significant M&A activity in the first quarter for mhealth companies. We have already seen 10 M&A transactions in Q1 compared to 21 in all of last year, which bodes well for exits in Mobile Health," said Mr Raj Prabhu, CEO and co-founder, Mercom Capital Group, in a statement. As per the report, Healthcare practice-centric companies raised $347 million in 44 deals in Q1 2015 compared to $568 million in 43 deals in Q4 2014. Areas that received the most funding under this category were Data Analytics companies with $92 million, Data Warehousing companies with $70 million, Health Insurance Exchange companies with $38 million, EHR/EMR companies with $36 million, and Practice Management Solutions companies with $34 million.   Consumer-centric companies raised $437 million in 98 deals this quarter compared to $643 million in 91 deals in Q4 2014. Mobile Health companies continued to attract the most VC funding bringing in $282 million in 56 deals, most of which went to mHealth Apps with $220 million. Telehealth companies secured $65 million while Rating and Comparison Shopping companies brought in $47 million. In India, Practo, a developer of a physician search engine closed $30 million (Rs 187 crore) in Series B funding from Sequoia Capital and Matrix Partners, during the January-March quarter 2015. Other deals in the country included $300,000 (Rs 1.86 crore) raised by eKincare, an online and offline platform that enables monitoring critical medical information.     ]]> https://biospectrumindia.com/features/97/6233/effective-documentation-through-im.html https://biospectrumindia.com/features/97/6233/effective-documentation-through-im.html Thu, 09 Apr 2015 09:28:00 +0530 Clear and effective documentation is of utmost importance across different sectors, more so in the Pharma and Biotech sector, where poor documentation can cause serious liabilities. Information Mapping (IM) is a documentation methodology which allows organizations to adopt a common writing standard. It ensures that organizations adopt IM as its content standard so that information is documented in a structured and a consistent manner. This methodology was developed by its founder Mr Robert Horn, a cognitive scientist from Harvard and Columbia University and is patent protected. "Our aim is to produce clear and efficient documentation. We standardize the way content is written within companies," said Mr Francis Declercq, CEO, Information Mapping. Ms Swapna Narayanan, managing director, IM India elaborated further, "Information Mapping is a global methodology. It is the standardization of content that is being developed in a company. We reach out to organizations and we train them in this methodology. We also give a piece of software which works with MS word, it allows (along with MS word) writing in a structured way. Using our standard methodology, it is information presented in smaller chunks enabling better comprehension, better readability and better usability of your document." The company also provides the technology as a service. "But we always see it from the customer's context, the need and then come up with a solution," said Ms Swapna.   Pharma and biotech companies have to produce lots of reports based on clinical trials and documentation. There is a need for regulatory compliance which, if not done properly, can have serious consequences, like the firms may end up being barred from producing the drugs because their drug report is not clear. "We had this in the US for a big pharma company, they were stopped from producing drugs for three years just because their documentation was not okay," said Mr Declercq. Globally, all the major pharma and biotech companies like Abbott, Baxter, Bristol-Myers Squib, J&J, Novartis, Pfizer, and Roche are clients and pharma companies from the US contribute about 30 percent to their business. Though internationally it is a very well-known methodology, in India it is relatively unheard of. "Our plan is to convince the major sectors that documenting their process, policies, procedures is working on risk mitigation, cost, and retention of their customer. The country contributes only 2-3 percent of their revenue. But we see it increasing to 10-15 percent in the next two to three years," Mr Francis said signing off.     ]]> https://biospectrumindia.com/reports-white-papers/97/5049/vc-funding-in-digital-health-drops-by-35-percent.html https://biospectrumindia.com/reports-white-papers/97/5049/vc-funding-in-digital-health-drops-by-35-percent.html Wed, 08 Apr 2015 11:17:59 +0530 Mercom Capital Group, llc, a global communications and research firm, released its report on funding and mergers and acquisitions (M&A) activity for the Healthcare Information Technology (IT)/ Digital Health sector for the first quarter of 2015. Mercom's comprehensive report covers deals of all sizes across the globe. Venture capital (VC) funding in the Health IT / Digital Health sector dipped by about 35 percent, coming in at $784 million in 142 deals compared to $1.2 billion in 134 deals in Q4 2014. Announced debt and public market financings in the sector amounted to $975 million in seven deals in Q1 2015 including one IPO, bringing the total corporate funding raised in the sector for Q1 2015, to almost $1.8 billion.Health IT / Digital Health companies have now raised almost $10 billion in VC funding since 2010. "Funding fell across the board with the exception of Mobile Health (mHealth), which was the bright spot this quarter. There was also significant M&A activity in the first quarter for mHealth companies. We have already seen 10 M&A transactions in Q1 compared to 21 in all of last year, which bodes well for exits in Mobile Health." commented Raj Prabhu, CEO and Co-Founder of Mercom Capital Group. Healthcare practice-centric companies raised $347 million in 44 deals in Q1 2015 compared to $568 million in 43 deals in Q4 2014. Areas that received the most funding under this category were Data Analytics companies with $92 million, Data Warehousing companies with $70 million, Health Insurance Exchange companies with $38 million, EHR/EMR companies with $36 million, and Practice Management Solutions companies with $34 million. Consumer-centric companies raised $437 million in 98 deals this quarter compared to $643 million in 91 deals in Q4 2014. Mobile Health companies continued to attract the most VC funding bringing in $282 million in 56 deals, most of which went to mHealth Apps with $220 million. Telehealth companies secured $65 million while Rating and Comparison Shopping companies brought in $47 million.   There were 65 early-stage deals under $2 million, including 16 accelerator/incubator deals in Q1. Seed stage accelerator/incubator deals have slowed with only six deals last quarter and 16 this quarter compared to 35 in Q1 2014. Top VC funding deals in Q1 2015 were the $70 million raise by Health Catalyst, a provider of healthcare data warehousing, the $55 million raised by Ayasdi, a big data analytics company, the $40 million each secured by Advance Health, a provider of a mobile patient data capture application for managed care providers, and ClassPass, a mobile membership app offering fitness and wellness classes across multiple gyms and studios, the $38 million raised by Collective Health, a cloud-based employer self-insurance platform, and the $30 million raised by Practo, developer of a physician search engine to book appointments and rate providers. A total of 288 investors and four accelerators/incubators participated in Healthcare IT deals this quarter. There were 11 investors that participated in multiple rounds. Investors with the most funding deals this quarter included GE Ventures with four, followed by Rock Health and Kaiser Permanente Ventures with three each. Globally, U.S. companies raised $716 million in 123 deals. Eleven other countries: India, Israel, Canada, Australia, Serbia, Spain, Finland, Singapore, Germany, Austria and the UK recorded deals this quarter. In the United States, 38 deals came out of California, followed by New York which recorded 13 deals, Massachusetts and Texas with 12 and eight deals respectively, and Wisconsin with five deals. There were 56 M&A transactions (14 disclosed) in the Health IT sector in Q1 2015 compared to 52 transactions (nine disclosed) in Q4 2014. Practice-focused companies lead M&A activity with 42 of the 56 transactions. Consumer-centric companies had 14 transactions in Q1 2015. Ten Mobile Health companies were acquired this quarter followed by seven Practice Management Solutions companies, five EHR/EMR companies, three Medical Imaging and three Data Analytics companies.   In terms of disclosed transactions, Mobile Health came out on top with $578 million, led by two acquisitions from Under Armour. The largest disclosed M&A transaction was the $475 million acquisition of MyFitnessPal, a nutrition and fitness platform that allows users to track their health goals and provides nutritional information, by Under Armour. This was followed by the $325 million acquisition of Studer Group, a provider of healthcare consulting services and software, by Huron Consulting. Performant Financial Corporation acquired Premier Healthcare Exchange, a provider of advanced cost management solutions for commercial health plans and third party administrators, for $130 million. HealthStream acquired HealthLine Systems, a provider of credentialing and contact center quality management software to the healthcare industry, for $88 million. Under Armour also acquired Endomondo, a developer of a mobile app and website that provides users a fitness community and allows them to track their workouts, for $85 million. Announced debt and public market financing in Health IT rose to $975 million in seven deals this quarter compared to the $299 million in eight deals in Q4 2014. There was one Digital Health IPO in Q1 2015: Invalon, a data analytics solutions company, which raised $600 million. There were a total of 546 companies and investors covered in this comprehensive report. ]]> https://biospectrumindia.com/news/97/7059/dreamed-diabetes-medtronic-collaborate.html https://biospectrumindia.com/news/97/7059/dreamed-diabetes-medtronic-collaborate.html Tue, 07 Apr 2015 11:32:43 +0530 DreaMed Diabetes, developer of diabetes treatment and management solutions, has announced that it has signed an exclusive worldwide development and license agreement with Medtronic. The partnership is for the development and marketing of products incorporating DreaMed's MD-Logic Artificial Pancreas algorithm in Medtronic's insulin pumps. Under the terms of the agreement, DreaMed Diabetes will receive undisclosed royalties from future sales of each device utilizing MD-Logic. Medtronic will be responsible for all development and marketing of such devices. In addition, Medtronic has made a minority investment in DreaMed Diabetes of $2 million. DreaMed Diabetes's CE approved GlucoSitter,which is based on the MD-Logic Artificial Pancreas algorithm, is a fully-automated, artificial-pancreas system for controlling glucose levels. The system links the glucose sensor with the insulin pump through computerized control algorithms. It uses data of glucose levels from a continuous glucose sensor, analyzes them and directs the insulin pump to deliver the correct dose of insulin that should be released to the body in order to maintain balanced blood glucose. In effect, the software continuously monitors glucose levels, and defines precisely when and how to adjust insulin levels. Prof. Moshe Phillip,chairman and chief Scientific Officer of DreaMed Diabetes, and director of the Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, said, "We are very excited that only one year since inception, we have signed a strategic collaboration agreement with Medtronic, the world leading medical device company. This is an extremely gratifying validation of our technology and a major milestone for our Company. We are certain that this partnership, which will incorporate our solution into Medtronic's integrated insulin pump and glucose monitoring system, will improve the health as well as the quality of life of people living with diabetes." Mr Alejandro Galindo, vice-president and general manager of the Intensive Insulin Management business at Medtronic, said, "We believe that a fully automated artificial pancreas will provide greater freedom and better health for many people with diabetes by eliminating some of the burden of glucose management. Collaboration with DreaMed Diabetes and researchers worldwide will allow us to continue to advance more quickly toward a commercially available closed loop system."       ]]> https://biospectrumindia.com/news/97/3152/bactiguard-changes-strategy-for-india.html https://biospectrumindia.com/news/97/3152/bactiguard-changes-strategy-for-india.html Mon, 06 Apr 2015 12:38:52 +0530 India remains an important growth market for Bactiguard. The cooperation with Cadila Pharmaceuticals, which was initiated in 2012 has, however, not provided the regulatory and market related benefits expected at the time, said the company's press statement. Therefore, Bactiguard is evaluating an alternative sales strategy, which paves the way for market launch and initiation of sales in 2015, as planned. Preparations for the launch and clinical studies are well under way. As a result of the above changes in strategy, Bactiguard has decided to make reservations in the interim results for the first quarter of 2015 for doubtful receivables, with a negative effect on results of approximately Million Swedish Kroner (MSEK) 24.   The reason being that the counterparties' willingness to pay is deemed questionable. During the first quarter of 2015, Bactiguard has reviewed and evaluated market conditions in Russia. Given the economic and political developments in the country, Bactiguard has decided to focus its marketing and sales efforts on other growth markets with greater potential, the company said. Consequently, Bactiguard has used its right to terminate the agreement with its Russian distributor. No product deliveries have been made to Russia so far and there are no outstanding commitments to deliver any products. The reservations have no effect on the company's cash position. ]]> https://biospectrumindia.com/news/97/7987/medtronic-to-provide-diabetes-care.html https://biospectrumindia.com/news/97/7987/medtronic-to-provide-diabetes-care.html Mon, 06 Apr 2015 12:38:33 +0530 Medtronic has announced the acquisition of Diabeter, an innovative, independent Netherlands-based diabetes clinic and research center dedicated to providing comprehensive and individualized care for children and young adults with diabetes. This acquisition combines the strengths of Medtronic and Diabeter to create a strong local and international platform for improving outcomes for people with diabetes. Mr Hooman Hakami, executive vice-president and president of the Diabetes Group at Medtronic said, "This acquisition marks Medtronic's first entry into a diabetes integrated care model approach and signifies that Medtronic Diabetes is more than pumps and sensors - we are a holistic diabetes management company focused on making a real difference in outcomes and cost." "Diabeter has been pioneering this type of integrated care in the Netherlands, and we believe this approach can be applied more broadly to serve more patients, in more places around the world," said Dr Henk Veeze, senior international medical director, Diabeter. He added, "We have developed a unique system with improved clinical outcomes, combining outstanding clinical care with devices and information technology." Diabeter will operate as a part of the Diabetes Services and Solutions business unit, which focuses on offering people with diabetes access to therapy, insights and services that will contribute to better clinical and economic value. The transaction is expected to meet Medtronic's long-term financial metrics for acquisitions, and the annualized earnings impact of this acquisition is not expected to be material.   This acquisition supports Medtronic's continued entry into integrated health solutions as part of the company's economic value strategy. It marks Medtronic's first entry into a diabetes integrated care model approach and is consistent with its move into new business models where its technologies and expertise can make a difference in patient care. Terms of the acquisition were not disclosed.   ]]> https://biospectrumindia.com/news/97/3911/baxter-announces-collaboration-with-laboratoire-aguettant.html https://biospectrumindia.com/news/97/3911/baxter-announces-collaboration-with-laboratoire-aguettant.html Mon, 06 Apr 2015 12:37:07 +0530 Baxter International and Laboratoire Aguettant has announced that they have signed an exclusive global licensing and distribution agreement for trace elements, which are essential micronutrients used in parenteral nutrition (PN) therapy. The collaboration allows Baxter to augment its leading PN portfolio, currently available in more than 90 countries, with essential trace elements. "Providing access to a comprehensive range of parenteral nutrition products is critical for patients who rely on IV administration of these nutrients," said Mr Brik Eyre, president of Baxter's Hospital Products business. He added, "This agreement complements Baxter's existing parenteral nutrition portfolio and provides clinicians with options to meet the individual needs of both chronic and critically ill parenteral nutrition patients." The agreement includes NUTRYELT concentrate solution for infusion (a multi-trace element product) for adults, and SELENIUM and ZINC (single-trace element products). NUTRYELT contains nine essential trace elements consistent with the most recent European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines for trace elements. NUTRYELT was approved in France, Germany, Poland and the United Kingdom in 2014, and is pending approval in 15 additional European countries. SELENIUM and ZINC are two of the most commonly used stand-alone trace elements. The companies will work together to pursue even broader global regulatory approvals for these products, including in the United States. Aguettant will retain ownership of the worldwide rights of the trace elements, and will directly market these products in France. "Aguettant and Baxter have previously partnered to provide trace elements in Europe, and during times of product shortages in the United States. This agreement significantly expands the internationalization of Aguettant. It brings together our companies' unique expertise, channels to market and technologies that will allow us to reach more patients with these essential nutritional products," said Mr Eric Rougemond, CEO of Laboratoire Aguettant SAS.     ]]> https://biospectrumindia.com/news/97/7140/baxter-receives-ce-mark-approval-for-dialysis-sysytem.html https://biospectrumindia.com/news/97/7140/baxter-receives-ce-mark-approval-for-dialysis-sysytem.html Sat, 04 Apr 2015 11:00:00 +0530 Baxter has announced the completion of CE marking (market approval) in Europe for HOMECHOICE CLARIA, an automated peritoneal dialysis (APD) system integrated with the SHARESOURCE web-based connectivity platform. The APD system is designed with user-friendly features and secure two-way connectivity so healthcare providers can have increased visibility to monitor their patients' home peritoneal dialysis (PD) treatments and adjust prescriptions as necessary. PD is a therapy option performed primarily at home by end-stage renal disease patients. ''CLARIA builds upon our market-leading HOMECHOICE APD device with new features to make the system more intuitive for patients to operate in their home and while traveling,'' said Dr Bruce Culleton, vice- president, renal therapeutic area lead, Baxter. He added,''Additionally, SHARESOURCE, the system's web-based platform, provides physicians remote access to their home patients' treatment information allowing for more timely and personalized care.'' HOMECHOICE CLARIA with SHARESOURCE is also designed to save clinics time and improve healthcare practice efficiencies by reducing manual input of data and gathering both patient and clinic data into organized patient report dashboards that are easily accessed and viewed by healthcare providers. In addition, the HOMECHOICE CLARIA system features a large, two-line display screen for better visibility, and a universal interface that is available in 41 languages. Baxter plans to initiate the commercial launch of HOMECHOICE CLARIA with SHARESOURCE in select European and Asian countries in the first half of 2015.   ''Every patient with end-stage renal disease deserves access to individualized care. HOMECHOICE CLARIA with SHARESOURCE represents Baxter's continued commitment to advancing renal technology that offers healthcare providers and patients therapy options for end-stage renal disease,'' said Mr Jill Schaaf, president of Baxter's Renal business.   ]]> https://biospectrumindia.com/news/97/7681/perkinelmer-launches-new-products.html https://biospectrumindia.com/news/97/7681/perkinelmer-launches-new-products.html Sat, 04 Apr 2015 09:30:00 +0530 PerkinElmer has announced the launch of its new Quantulus GCT and Tri-Carb 4810TR, 4910TR and 5110TR liquid scintillation counters (LSCs). These modernized benchtop systems, which are among the most sensitive available in the marketplace, measure low levels of radioactivity and perform advanced particle discrimination. They also feature reduced counting times for detecting alpha, beta and gamma radioactivity. "PerkinElmer combines more than 60 years of experience developing liquid scintillation technology with our comprehensive portfolio of reagents, cocktails and assays to support radiometric detection," said Mr Brian Kim, president, Life Sciences and Technology, PerkinElmer. He added, "Our new LSCs help life sciences and environmental researchers make informed decisions about drug pathways, determine contamination levels in the environment, and comply with safety regulations." The Quantulus GCT liquid scintillation counter is a benchtop instrument that identifies and measures very low concentrations of man-made, cosmogenic and other natural radionuclides. It is suited for environmental monitoring and contamination control, which require detection of ultra low-level alpha and beta radioactivity. The Tri-Carb family of LSCs are computer-controlled benchtop instruments that perform particle discrimination with reduced counting times for detecting very small amounts of alpha, beta and gamma radioactivity. These highly sensitive LSCs can meet the requirements of demanding academic, pharmaceutical, including ADME-Tox, environmental, and nuclear power research applications.   ]]> https://biospectrumindia.com/news/97/5221/abbott-introduces-glucose-monitoring-system.html https://biospectrumindia.com/news/97/5221/abbott-introduces-glucose-monitoring-system.html Fri, 03 Apr 2015 10:11:00 +0530 Abbott has launched the professional version of its flash glucose monitoring system. "Abbott has chosen India as the first country globally to launch this technology. The glucose assessment tool will cost Rs 1,999 for 14-days, will empower doctors to help their patients manage their diabetes effectively," said Mr Matthew Bates, R&D director, Abbott Diabetes Care, in a statement. "The glucose monitoring system continuously measures glucose in interstitial fluid through a small filament that is inserted under the skin. It records glucose levels every 15 minutes, capturing up to 1,340 glucose readings over 14 days, thus giving the treating doctor comprehensive data for a complete glucose profile of their patient," explained Mr Bates. After 14 days the doctor uses a flash glucose monitoring reader to scan the sensor and download the glucose results. This data can help doctors to make more informed treatment decisions.         ]]> https://biospectrumindia.com/news/97/4368/ges-revolution-act-its-made-in-india-for-india.html https://biospectrumindia.com/news/97/4368/ges-revolution-act-its-made-in-india-for-india.html Thu, 02 Apr 2015 16:01:13 +0530 The product is the result of investments worth Rs 120 crore (USD 20 million) and the collaborative efforts of about 50 GE and Indian healthcare providers for over 4 years. Mr Kaushik Mukherjee, IAS, chief secretary, Karnataka, and Dr Prathap C Reddy, chairman, Apollo Hospitals, were also present at the launching ceremony, along with Mr John Flannery, president and CEO, GE Healthcare, and Ms Terri Bresenham, president & CEO, GE Healthcare South Asia. Dr Prathap stressed that the industry cannot keep importing devices. "Apart from expecting fast growth, we need to make and innovate in India at all levels," he emphasized. Mr John Flannery spoke in terms of relevance of global healthcare systems in India. "Our sales in India are much higher than we imagined. We have products that bring incredible value to people," he commented. The product is also expected to be launched in other markets, Mr Flannery said.   Revolution ACT will be GE's 26th product launch here in India, and the company, now, has been manufacturing products in the country for 20 years. Till now all the CT machines in India were imported at exorbitant prices. "The single biggest challenge is enabling a comfortable life for people who 'make in India'. It is easy to produce equipments and devices for people who can pay for it. The challenge is to produce and offer something for people at lower costs, rather than worrying about the exports," pointed Mr Mukherjee. The product is said to be 40 percent cheaper than the existing machines and will consume less electricity. "The newly launched CT system will be sold at less than a crore, depending on the configuration needs," added Ms Terri Bresenham, president & CEO, GE Healthcare South Asia.   GE Healthcare has recently formed a new national network - GenWorks Health, endeavouring to address severe healthcare challenges faced by Indian healthcare providers in tier II-IV towns. GenWorks has commenced operations with 150 highly experienced team members. The national network is building presence in 450 tier II-IV towns to take disruptive technologies, training and support closer to healthcare providers in a bid to give these first time users a high quality user experience. "All initiatives to develop relevant technologies would be meaningless if they are not accessible to all, and hence we also invested and built a national network, which will help us take these technologies to the grass root level...," said Ms Terri. ]]> https://biospectrumindia.com/news/97/6495/quintiles-quest-diagnostics-form-jv-.html https://biospectrumindia.com/news/97/6495/quintiles-quest-diagnostics-form-jv-.html Thu, 02 Apr 2015 12:06:52 +0530 Quintiles and Quest Diagnostics announced a definitive agreement to form a global clinical trials laboratory services business. The transaction, which is subject to standard and customary closing conditions, is anticipated to close in the third quarter of 2015. The financial terms of this transaction were not disclosed. The new entity will provide customers with the depth of capabilities and end-to-end clinical trial laboratory services required to succeed in the increasingly complex biopharmaceutical industry. Mr Steve Rusckowski, CEO, Quest Diagnostics added, "For Quest Diagnostics, the joint venture model will enable us to generate growth and value from our clinical trials assets while simultaneously strengthening our focus on our core diagnostic information services business."   The new entity will offer a compelling value proposition to solidify its position as the second-largest central laboratory services company in the world. Mr Tom Pike, CEO, Quintiles, commented, "....We're excited about the opportunities ahead of us and the benefits we can provide customers." Beyond the immediate opportunity in laboratory services support for clinical trials, the two companies expect to benefit from opportunities to collaborate in other areas. These include new ways to enhance patient recruiting and retention for clinical trials; speed the validation, development and commercialization of companion diagnostics; enhance support of real-world late phase studies; and develop new population-health analytics and tools. ]]> https://biospectrumindia.com/news/97/6113/google-ventures-invests-in-telemedicine-firm-spruce.html https://biospectrumindia.com/news/97/6113/google-ventures-invests-in-telemedicine-firm-spruce.html Wed, 01 Apr 2015 11:05:00 +0530 Spruce, a dermatology telemedicine company has announced a $15 million Series A financing and the launch of an expanded product that supports comprehensive, high-quality care for a broad set of dermatological conditions. The $15 million financing is led by Kleiner Perkins Caufield and Byers with participation from Baseline Ventures, Cowboy Ventures, and Google Ventures. "Patients and dermatologists have loved the experience Spruce provides for acne treatment, and we are excited to now enable high-quality care for a wide range of dermatological concerns," said Mr Ray Bradford, CEO of Spruce. With this latest product release, it is possible to consult a board-certified dermatologist on Spruce for a wide range of dermatological conditions, including fine lines and wrinkles, skin discoloration, rosacea, eczema, psoriasis, male hair loss, eyelash thinning, rashes, bug bites and stings, and more. "With Spruce, we're trying to remove access barriers for patients, but we're equally focused on how we can improve upon the care experience itself for both patients and dermatologists," said Mr Bradford. He added, "One of the things dermatologists on Spruce like most is the opportunity for improved adherence and outcomes because patients have detailed instructions with them at all times and can ask follow-up questions. The Spruce software for dermatologists makes it easy for them to treat patients from iPads anytime, anywhere at a high standard of care. It also streamlines their workflows, so their time is spent on personalizing care instead of paperwork and administration."   ]]> https://biospectrumindia.com/news/97/7864/ge-healthcare-launches-yogya-bharat-for-an-aarogya-bharat-.html https://biospectrumindia.com/news/97/7864/ge-healthcare-launches-yogya-bharat-for-an-aarogya-bharat-.html Wed, 01 Apr 2015 10:36:39 +0530 GE Healthcare has launched a mission to accelerate the building of a "Yogya Bharat" or "Skilled India" that will improve access to quality healthcare throughout the country. The company has partnered with leading healthcare and education experts to set up healthcare education and training institutes that will provide accredited skill building programs for 12th Standard pass eligible students and skill enhancement programs for existing healthcare professionals. The first few healthcare education and training institutes with state-of-the-art healthcare infrastructure will commence operations in Mumbai, Greater Noida, Bhatinda, and Bhubaneshwar. Through healthcare education and training institutes across the country, GE Healthcare, along with its partners, aims to train and contribute 100,000 skilled healthcare workforce to strengthen India's healthcare system over the next five years. This workforce will include newly trained, certified employable professionals for allied health care services as well as skill enhanced healthcare professionals who are in the system already. GE Healthcare has developed the curriculum for several courses including imaging, patient safety, advanced medical diagnostics and leadership development. National Skill Development Corporation India, through the Healthcare Sector Skills Council, is playing a key role in defining curriculum for these courses and supporting accreditation. Partners bring in a variety of critical strengths to the program like infrastructure, equipment for hands on training, clinical environment for trainees, academic advisory and technological capabilities, as well as a wealth of expertise in learning development. GE Healthcare aims to set up at least one healthcare education and training institute in each State and has already signed Memorandum of Understanding with several leading institutions both in Government and the private sector. GE Healthcare and its partners pledged their commitment to a Yogya Bharat in the presence of Mr Dilip Chenoy, Managing Director and CEO, National Skills Development Corporation. Congratulating GE Healthcare on the new venture, Mr Dilip Chenoy, MD and CEO, National Skills Development Corporation said, "A skilled workforce is key to the growth of any nation. The need of the hour is to create the ecosystem to maintain a constant supply of trained talent that is ready to join the mainstream and enable expansion of the healthcare infrastructure in the country. We congratulate GE Healthcare for its initiative to train and help develop skilled workforce for a more robust healthcare ecosystem. Not only will this initiative bridge the deep skills gap that exists in the sector but also enhance employability in the country." "The initiative is among the largest skill enhancement programs for GE Healthcare in the world. This is a great example of how we can use our scale and experience to partner with India. GE Healthcare was the first company to manufacture high-end healthcare equipment in India in 1991. As an innovator of affordable, localized solutions, our goal has been to enhance accessibility to quality healthcare for every Indian. We hope that the skilling of 100,000 healthcare professionals will address an important Government priority of bridging the skill deficit," said Mr John L Flannery, president and CEO of GE Healthcare. Talking about the mission, Ms Terri Bresenham, president and CEO, GE Healthcare India said, "This is a landmark initiative in our 25-year history in India. We believe a skilled India is absolutely necessary for a healthier India. As a leader in healthcare, GE Healthcare looks to continue playing a crucial role in the growth of India's healthcare system. We stand committed to partnering with public and private players in the healthcare sector to make this endeavour a success."   The first institute which commenced operations in Mumbai is fully funded and run by GE Healthcare with the first batch of students taking up Radiology Technologist certified program.   ]]> https://biospectrumindia.com/news/97/8360/mr-bhartia-resigns-as-jubilants-md.html https://biospectrumindia.com/news/97/8360/mr-bhartia-resigns-as-jubilants-md.html Tue, 31 Mar 2015 14:39:00 +0530 Jubilant Life Sciences informed BSE that consequent to appointment of Mr Shyam S Bhartia as chairman and managing director of Jubilant Pharma, Singapore, a wholly-owned subsidiary of Jubilant Life Sciences, he has resigned from the position of MD of the company effective from March 25, 2015. In view of the above, Mr Shyam S Bhartia shall be non-executive chairman and director of the company. ]]> https://biospectrumindia.com/news/97/6324/large-scale-stem-cell-expansion-feasible.html https://biospectrumindia.com/news/97/6324/large-scale-stem-cell-expansion-feasible.html Tue, 31 Mar 2015 12:19:22 +0530 A collaboration between Eppendorf and Florida State University has successfully shown the feasibility of large-scale expansion of human mesenchymal stem cells (MSC),  using the company's proprietary Fibra-Cel packed-bed technology. Dr Ma Sha, director of Technical Applications at Eppendorf, provided equipment and funding for reagents to Dr Teng Ma to support the Florida State team's work in the field of stem cell expansion. The team successfully conducted MSC expansion inside a packed-bed 3D matrix using a CelliGen 310 bioreactor at ~2 L scale. The results demonstrate the feasibility of large-scale stem cell expansion using the company's patented Fibra-Cel packed-bed technology which provides uniform mass transfer of nutrients and oxygen to the adhered cells. The finding will be submitted for publication in a peer reviewed scientific journal.     ]]> https://biospectrumindia.com/news/97/6668/fujifilm-holdings-to-acquire-cellular-dynamics-.html https://biospectrumindia.com/news/97/6668/fujifilm-holdings-to-acquire-cellular-dynamics-.html Tue, 31 Mar 2015 11:31:32 +0530 FUJIFILM Holdings and Cellular Dynamics International (CDI) have announced that the two companies have entered into a definitive agreement. Fujifilm will acquire CDI via an all-cash tender offer to be followed by a second step merger. Fujifilm aims to acquire all issued and outstanding shares of CDI's common stock for $16.5 per share or approximately $307 million (on a fully diluted basis). The offer represents a premium of 108 percent to CDI's closing price on March 27. Upon completion of the transaction, CDI will continue to run its operations in Madison, Wisconsin and Novato, California as a consolidated subsidiary of Fujifilm. The announced transaction was unanimously approved by the Boards of Directors of both companies. Under the terms of the agreement, Fujifilm will commence an all-cash tender offer no later than April 6, 2015. The transaction is conditioned on the tender achieving the minimum acceptance threshold, regulatory approvals and other customary conditions. Fujifilm will finance the transaction from the cash on its balance sheet and the completion of the acquisition is not subject to any financing conditions. It is anticipated that the tender offer will close during the second calendar quarter of 2015. CDI's technology platform enables the production of high-quality fully functioning human cells, including induced pluripotent stem cells (iPSCs), on an industrial scale.   Commenting on the transaction, Mr Shigetaka Komori, chairman and CEO of Fujifilm, said, "We are delighted to be able to pursue the business from drug discovery to regenerative medicine with CDI, which develops and manufactures iPS cells. We have optimal scaffolding material, 'recombinant peptides', for cell generation and technologies useful for regenerative medicines such as material science and engineering. Our group company, Japan Tissue Engineering, markets regenerative medicine products in Japan. By welcoming CDI to the Fujifilm Group and by combining the technologies and knowhow of both companies, we will seek synergies and efficiencies to be more competitive in the field of drug discovery and regenerative medicine." "CDI and Fujifilm share a common strategic vision for achieving leadership in the field of regenerative medicine. The combination of CDI's technology with Fujifilm's technologies, know-how, and resources brings us ever closer to realizing the promise of discovering better, safer medicines and developing new cell therapies based on iPSCs," said Mr Robert J Palay, chairman and CEO, CDI. Goldman Sachs is acting as the financial advisor to Fujifilm and Morrison & Foerster is acting as its legal counsel. JP Morgan is acting as financial advisor to CDI and Sidley Austin is acting as the legal counsel.   ]]> https://biospectrumindia.com/news/97/5211/leucine-rich-bio-nextgen-life-sciences-collaborate.html https://biospectrumindia.com/news/97/5211/leucine-rich-bio-nextgen-life-sciences-collaborate.html Tue, 31 Mar 2015 10:35:18 +0530 Leucine Rich Bio (LRB) has announced an alliance partnership with NextGen Life sciences for promoting its products and services. According to the MoU signed between LRB and NextGen Life sciences, NextGen Life Sciences would provide its market depth and field penetration to promote LRB's products and services. Speaking on this occasion, Dr Debojyoti Dhar, director (Business development and Innovation), LRB said, "Getting NextGen Life sciences on board our journey at this stage is very important for LRB and we feel that our two companies can complement each other well and we look forward to a mutually rewarding association". "Our rich experience in the Indian lifesciences market makes us confident that NextGen Life Sciences will successfully integrate LRB products and services in India and will be growing business further together. With the addition of LRB, we are in an even stronger position to help our customers to achieve their goals for innovation and productivity. Our combine offerings will provide cutting edge technologies to accelerate Life Sciences Research and improve human health," said Dr Nagma Abbasi, MD, NextGen Life Sciences. LRB operates in a niche domain of NGS data analysis and is involved in providing 'software as a service' utilizing its proprietary in-house developed Human Genome Analysis, Interpretation and Reporting platform called AGIS (Advanced Genome Interpretation Suite).   LRB plans to launch AGIS for clinics and diagnostics wherein it would cater to the developing field of 'personalized genomics'.   ]]> https://biospectrumindia.com/news/97/5311/strand-mriglobal-collaborate-on-infectious-disease-diagnostics-.html https://biospectrumindia.com/news/97/5311/strand-mriglobal-collaborate-on-infectious-disease-diagnostics-.html Mon, 30 Mar 2015 14:06:33 +0530 Bangalore-based Strand Life Sciences entered into a partnership with US-based MRIGlobal, an independent non-profit organization performing contract research for government and industry. The partnership is said to be an important step in the right direction towards enabling a focussed area of development and validation of tests for infectious disease diagnosis. Strand and MRIGlobal will work towards successfully co-developing complex and high-end diagnostics. At a global level, Strand and MRIGlobal will conduct joint R&D to integrate Strand SmartLab, which delivers NGS-based diagnostic lab and informatics solutions for oncology and other diseases, with MRIGlobal's Mobile Labs, which are deployed in resource-limited environments, to enable rapid disease diagnosis. Mr Kay van der Horst, VP, research, development, engineering & testing operation, MRIGlobal, said, "In the last 10 years, there has been biosecurity threats, natural disasters, and the emergence of H1N1, SARS and Ebola. We emphasize on taking the knowledge and creating diagnostics solutions, and bringing knowledge in to public health response and preparedness along with innovating next-generation diagnostics solutions."   MRIGlobal was established in 1944 and operates in 25 countries. The organization was erected to support the government with R&D, and developing innovative technologies and solutions, particularly in chemical and biological sciences. As part of the vision laid out in the partnership, Strand and MRIGlobal will bring together respective capabilities in biopharmaceutical clinical trials to co-develop companion diagnostics for drugs in cancer and other diseases. Mr Kay continued, "We are also working with Strand in bringing point-of-care diagnostics. If we can diagnose diseases when patients arrive at the point-of-care, then that will have better clinical outcomes." Strand's will lead the genomic biomarker discovery, patient stratification strategy, companion diagnostic test design, bioinformatics data analysis/ interpretation aspects of the project, while MRIGlobal will perform independent validation of assays in their own lab in US, and help secure FDA approval for such co-developed diagnostic tests. Dr Vijay Chandru, chairman & CEO, Strand Life Sciences, added that India faces serious challenges in the health sector. "I wish there was a special category to the health sector, especially in terms of the technological side. Space, defense, and atomic energy have been declared as strategic sectors in the country, and they have certain privileges on how innovation and R&D is pursued in those sectors. We desperately need to bring in health sector in that domain," Dr Chandru suggested. He also stressed that health crises need to be handled as 'mission critical', as we did for the Mars mission. "There is great opportunity in the field of molecular biology and Next-Generation Sequencing (NGS). India has the capabilities of being a great contributor in these fields and stand shoulder-to-shoulder with the pace of the world," he noted. ]]> https://biospectrumindia.com/news/97/5225/icon-collaborates-with-carnegie-mellon-university.html https://biospectrumindia.com/news/97/5225/icon-collaborates-with-carnegie-mellon-university.html Sat, 28 Mar 2015 09:46:00 +0530 ICON has announced that it is sponsoring a series of research projects to find new ways to improve information comprehension and retention by clinical trial participants. The projects are led by Professor Baruch Fischhoff, Carnegie Mellon University (CMU). The research tools will include multimedia solutions from ICON's Firecrest suite of products. "We are looking into ways to help patients make well-informed decisions about whether to participate in clinical trials," said Professor Fischhoff. He added, "Our research will take advantage of advances in behavioural decision research and information technology to design and evaluate approaches for ensuring that patients understand the potential risks and benefits of joining trials." "Successful patient enrolment in clinical trials is dependent on an informed consent process that thoroughly and consistently explains the trial and instils trust in the patient," commented Mr Frances Abeton, VP firecrest, at ICON plc. He added, "The CMU research projects are designed to scientifically test, measure and validate what patients need in order to ensure truly informed consent. We also want to know how the presentation of clinical trial information affects patient understanding, confidence and trust." Following scientific peer review, the results of these studies will be accessible to the public and will influence the development of new ICON innovations, including a range of study management tools from Firecrest. Firecrest tools include investigator training, patient recruitment and retention services, eConsent, mobile data capture and an integrated patient and investigator portal, which greatly improve the compliance, consistency and quality of study-related activities by study personnel.   ]]> https://biospectrumindia.com/news/97/6353/agilent-receives-award-for-outstanding-customer-service.html https://biospectrumindia.com/news/97/6353/agilent-receives-award-for-outstanding-customer-service.html Sat, 28 Mar 2015 09:40:00 +0530 Agilent Technologies has been recognized with a Reviewers' Choice Award for outstanding customer service from SelectScience, an independent, expert-led scientific review. SelectScience reviewers, which include scientists from around the world, judged Agilent's customer service to be the best in the laboratory products industry. "Agilent is honored to be recognized by our customers through SelectScience. It's a validation of our highly trained engineers and the relentless focus we all put on customer service. We believe that this recognition stems from Agilent's ability to be a true partner, always putting our customers first and ensuring that they can focus on producing life-changing results," said Mr Doug McDougall, vice-president and general manager of Global Customer Service Operations, Agilent. "The Reviewers' Choice Awards showcase the power of impartial reviews and enable scientists to make informed purchasing decisions," said SelectScience editor-in-chief Mr Kerry Parker. The Reviewers' Choice Awards are the newest category of SelectScience's annual Scientists' Choice Awards.       ]]> https://biospectrumindia.com/news/97/6095/biomedical-systems-announces-affiliation-with-the-epro-consortium.html https://biospectrumindia.com/news/97/6095/biomedical-systems-announces-affiliation-with-the-epro-consortium.html Thu, 26 Mar 2015 09:57:00 +0530 Biomedical Systems has announced its affiliation with the Electronic Patient-Reported Outcome (ePRO) Consortium, a program run by the Critical Path Institute (C-Path). The company will collaborate with the group's 10 other members to advance the quality, practicality and acceptance of electronic data capture (EDC) methods used in clinical trials for PRO endpoint assessment. "Clinical outcome assessments are becoming more important in clinical trials to determine whether a drug has demonstrated a treatment benefit. By joining the ePRO Consortium, Biomedical Systems will contribute in a non-competitive and neutral environment to improve the quality of data collection methods for clinical outcomes assessments," said Mr Timothy Barrett, chief operating officer at Biomedical Systems. With this new partnership, Biomedical Systems reinforces its dedication to the advancement of ePRO to increase the quality of data for electronic data capture. Its second generation ePRO platform supports home, site and Web-based systems to collect timely, high-quality data for clinical trials worldwide. C-Path is a nonprofit, public-private partnership with the United States Food and Drug Administration (USFDA) and is dedicated to bringing scientists from the FDA, industry and academia together to improve the drug development and regulatory process for medical products.   ]]> https://biospectrumindia.com/news/97/1307/next-gen-transcatheter-aortic-valve-replacements-to-drive-rapid-market-growth.html https://biospectrumindia.com/news/97/1307/next-gen-transcatheter-aortic-valve-replacements-to-drive-rapid-market-growth.html Wed, 25 Mar 2015 12:54:25 +0530 The global market value for transcatheter heart valves will expand at an impressive compound annual growth rate (CAGR) of 19.7 percent, from almost $881 million in 2013 to around $3.02 billion by 2020, according to research and consulting firm GlobalData. The company's report states that this is almost three times the projected value of the tissue heart valves market, which will increase at a much slower CAGR of 3.2 percent to just under $1.08 billion over the same period. GlobalData's forecast only considers aortic valve replacement, as there are not yet any approved Transcatheter Mitral Valve Replacement (TMVR) devices. The approval of TMVR devices will have a significant impact on this forecast, but early adoption rates are expected to be slow due to initial cost. While surgical valves will hold a steady presence in the overall prosthetic valve market, Transcatheter Aortic Valve Replacement (TAVR) is expected to cannibalize a large portion of this market in the coming decade.   As increasing competition drives down device costs, patients will subsequently have better access to minimally invasive treatment. Mr Premdharan Meyyan, GlobalData's analyst covering medical devices, says that while first-generation devices have shown promising clinical outcomes to date, physicians have noted issues such as paravalvular regurgitation and a lack of repositionability. He explained: "Transcatheter valves that are fully repositionable and retrievable address some of the main issues inherent in earlier products. Notable devices include Boston Scientific's Lotus Valve System, Edwards Lifesciences' SAPIEN 3, and Medtronic's CoreValve Evolut R, the latter of which recently displayed a 6.5 percent improvement in all-cause mortality rate compared to open-heart surgery at the two-year mark. "The adoption of these next-generation valves is expected to drive significant market growth, provided that clinical data continues to show positive mortality and morbidity outcomes for patients." The analyst adds that as only high-risk or inoperable aortic valve disease patients are currently eligible for TAVR, more robust, long-term clinical data must be established before the treatment is offered to lower-risk patients. "Until then, physicians will likely opt for the surgical option, as there is a multitude of clinical data proving efficacy. However, we believe it is likely that the indications for TAVR will expand and the technology will begin to dominate the surgical market over the forecast period," Mr Meyyan concluded. ]]> https://biospectrumindia.com/news/97/6041/ges-omnyx-collaborates-with-clarient-diagnostic-.html https://biospectrumindia.com/news/97/6041/ges-omnyx-collaborates-with-clarient-diagnostic-.html Wed, 25 Mar 2015 12:25:42 +0530 GE Healthcare has announced a strategic collaboration between its digital pathology joint venture, Omnyx, and its diagnostic laboratory services company, Clarient Diagnostic Services. Clarient will soon begin to integrate the Omnyx proprietary software platform into its current laboratory. "The clinical reality is that fighting cancer begins with an accurate diagnosis," said Dr Kenneth J Bloom, chief medical officer of Clarient. He added, "Cancer diagnosis and treatment is most effective as it becomes more personalized - and that means the role of the pathologist is crucial. By teaming up with Omnyx, we are helping to ensure that regardless of location or the size of the pathology lab in your hospital, a pathologist has a network that can discuss and help them identify the characteristics of a tumor, and offer more personalized diagnoses and treatments." Omnyx and Clarient will create a central resource of diagnostic technologies, including molecular signatures, bio-markers and precision analytics, so pathologists can help better identify trends and collaborate with one another to compare readings. "As pathologists take on greater workloads, the emerging field of digital pathology allows them to review cases jointly, more quickly and more accurately thanks to collaborative input from peers across the globe. Our Clarient and Omnyx alliance will provide pathologists with state-of-the art testing and diagnostic services to bring digital solutions as a mainstream offering in the healthcare world," said Mr Mamar Gelaye, CEO of Omnyx.         ]]> https://biospectrumindia.com/news/97/6729/make-in-india-boon-for-medtech-sector.html https://biospectrumindia.com/news/97/6729/make-in-india-boon-for-medtech-sector.html Wed, 25 Mar 2015 09:29:00 +0530 Prime Minister Mr Narendra Modi's "Make in India" campaign throws up opportunities for growth of domestic medical devices industry, which is not only underinvested but heavily import-oriented at present, says WHO. "With the current, 'Make in India' campaign, there is a huge opportunity for growth and expansion of the medical device industry. This would highly improve the access of essential medical devices and health care technology to patients in the country," said WHO Representative to India, Ms Nata Menabde, in a statement. She was speaking at an event to formally announce the commencement of National Health Systems Resource Centre (NHSRC), as the WHO collaborating centre for Priority Medical Devices and Health Technology Policy. The division of healthcare technology and innovation at NHSRC has been working in the area of health technologies and related policy interface. Its works includes framing of technical specifications for technologies procured under National Health Mission, best practices for technology life-cycle management and maintenance, secretariat for assessment and uptake of innovations into public health systems among others, according to a statement by NHSRC.     ]]> https://biospectrumindia.com/news/97/6251/transasia-introduces-new-range-of-reagents.html https://biospectrumindia.com/news/97/6251/transasia-introduces-new-range-of-reagents.html Wed, 25 Mar 2015 09:16:00 +0530 Transasia Bio-Medicals has announced the launch of three new products viz ERBA Lipase XL system pack, ERBA Enzymatic Creatinine system pack and ERBA Bilirubin DCA (Total & Direct) system pack. ERBA Lipase XL System Pack is readily adaptable, ready to use liquid stable assay-ideal for most open chemistry analyzers. It is compatible with both serum and plasma samples. The assay provides ten fold reduction in interference from triglycerides in comparison to 1 & 2 triglyceride method and gives results in 10 minutes. Enzymatic creatinine, a new method for estimation is widely accepted as one of the most accurate routine methods currently available. The ERBA enzymatic creatinine system pack offers Improved specificity, Smaller sample volume, High throughput, No interference by glucose, acetoacetate, and cefoxitin and Negative interference by bilirubin, which depends on both creatinine and bilirubin concentrations. ERBA Bilirubin DCA (Total & Direct) system pack offers liquid-stable, ready-to-use reagent, Linearity up to 14.75 mg/dl, Measuring range- 0.064-14.75 mg/dl, No interferences by lipemia, hemoglobin and ascorbic acid and Convenient reagent packing.   ]]> https://biospectrumindia.com/news/97/5812/tfs-unveils-new-ce-ivd-fusion-transcript-kit-for-ngs.html https://biospectrumindia.com/news/97/5812/tfs-unveils-new-ce-ivd-fusion-transcript-kit-for-ngs.html Tue, 24 Mar 2015 13:02:40 +0530 Thermo Fisher Scientific announced the release of the CE-IVD Oncomine Solid Tumour Fusion Transcript kit, a key solution designed to aid clinical decision-making and enable highly accurate and reliable multiplexed sequencing of formalin-fixed, paraffin embedded (FFPE) tumor samples. Marked for in vitro diagnostic use in the European Union, the Oncomine Solid Tumour Fusion Transcript kit for next-generation sequencing (NGS) enables the detection of rearrangements involving the ALK, ROS-1, RET, and NTRK1 genes from as little as 10ng of RNA. "This latest kit enables our clinical customers to detect multiple genetic rearrangements from each tumor sample," said Mr Mike Nolan, VP & GM, oncology, Thermo Fisher Scientific (TFS). "When used with our previously released CE-IVD Oncomine Solid Tumour DNA kit, mutations can be identified simultaneously with fusion transcripts, all in a single streamlined procedure." ]]> https://biospectrumindia.com/news/97/5813/dr-reddys-enters-into-partnership-with-hetero-.html https://biospectrumindia.com/news/97/5813/dr-reddys-enters-into-partnership-with-hetero-.html Tue, 24 Mar 2015 13:00:23 +0530 Dr Reddy's Laboratories announced that it has entered into an agreement with Hyderabad-based Hetero Drugs Limited, under which Dr Reddy's has been licensed to distribute and market Sofosbuvir 400 mg tablets, indicated in the treatment of chronic hepatitis C, under the brand name Resof, in India. According to the World health Organization (WHO), close to 12 million Indians suffer from chronic hepatitis C, a disease that can seriously affect the liver, leading to potentially life-threatening complications, including cancer of the liver. Complications arising out of untreated hepatitis C can precipitate faster in co-morbid conditions, such as Diabetes. With the diagnosis rates for hepatitis C in India being abysmally low, Dr Reddy's will make a significant difference in the diagnosis and treatment of this disease. Clinical studies have indicated that Sofosbuvir 400 mg in combination with other agents achieved very high cure rates, while shortening the duration of treatment to as little as 12 weeks and reducing or completely eliminating the need for interferon injections, depending on the viral genotype.   Resof is a breakthrough medicine and will simplify the traditional and complicated treatment options available today, allowing patients suffering from chronic hepatitis C access to a far more affordable and effective treatment regimen, as compared to existing ones Dr Reddy's co-chairman & CEO, Mr GV Prasad, commented, "The launch of Resof.... will provide significant relief to patients, resulting in potential cure and a high barrier to resistance at an affordable price for those living with hepatitis C."   ]]> https://biospectrumindia.com/news/97/5778/hmd-launches-safety-iv-cannula-with-sip-clip.html https://biospectrumindia.com/news/97/5778/hmd-launches-safety-iv-cannula-with-sip-clip.html Tue, 24 Mar 2015 09:17:00 +0530 Hindustan Syringes and Medical Devices (HMD) launches the next generation Cathy Safety IV Cannula with SIP CLIP, for preventing Needle Stick Injuries. "We are particularly excited about the prospects of our latest offering 'Safety IV Cannula with this Sharps Injury Prevention SIP Clip', which will certainly boost our export profile. We soon will be exporting this product to more than 20 countries by 2017. We have already shipped over 1.5 million IV Cannulas to Scandinavia recently and have received excellent feedback and clinical acceptance," said Mr Rajiv Nath, joint MD, HMD. He added, "For one, this patented design greatly minimizes the chances of needle stick injury to a nurse after she attaches a IV Catheter and removed the blood infected needle from a patient which results in numerous unfortunate infections and even deaths, particularly in developing countries like India. Most of these are not reported. This will greatly enhance health safety of our hospital staff and health workers and they deserve this. Our next generation cannula is designed not only to minimize health risks associated with accidental needle injuries but will also help bring down substantially the overall cost resulting from treatment of diseases like Hepatitis and HIV due to needle stick injuries and resultant nosocomial infections." It may be pointed that needle-stick injuries are common among healthcare staff and workers. Nurses are the largest single victim group, and have high rates of injury. According to WHO, if Safety Cannula are made mandatory in hospitals, then around 80 percent of all hospital staff can be saved from needle stick injuries.   ]]> https://biospectrumindia.com/news/97/4930/boston-scientific-announces-fda-and-ce-mark-approval-for-emblem-s-icd-system.html https://biospectrumindia.com/news/97/4930/boston-scientific-announces-fda-and-ce-mark-approval-for-emblem-s-icd-system.html Fri, 20 Mar 2015 12:25:45 +0530 Boston Scientific has received FDA and CE Mark approval for the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System. The EMBLEM S-ICD System is a treatment option that provides protection for patients at risk of sudden cardiac arrest (SCA), yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators (TV-ICDs). "We are excited to offer the second generation S-ICD System to physicians as a compelling treatment option for the majority of ICD-indicated patients. With the already established robust safety and efficacy clinical data, the EMBLEM S-ICD System is designed to enhance patient comfort, while still providing a less invasive treatment for patients at risk of cardiac arrest," said Dr Kenneth Stein, chief medical officer, rhythm management, Boston Scientific. Unlike traditional ICDs that require placement of at least one lead in or on the heart, the S-ICD System is implanted just under the skin and provides the patient the same protection from cardiac arrest without invading the heart and blood vessels. The new generation EMBLEM S-ICD System is 19 percent thinner and is projected to last 40 percent longer than the previous S-ICD System. These improvements will further improve patient comfort and cosmetic outcomes while reducing the number of times the device will require replacement. The EMBLEM S-ICD System is also enabled for remote patient management through the LATITUDE NXT Patient Management System for increased patient convenience.     ]]> https://biospectrumindia.com/news/97/4932/aiims-launches-an-ivrs-appointment-system.html https://biospectrumindia.com/news/97/4932/aiims-launches-an-ivrs-appointment-system.html Fri, 20 Mar 2015 11:43:40 +0530 AIIMS has launched a Patient Appointment System over Nuance ASR (Automatic Speech Recognition) based IVRS (Interactive Voice Response System). This is to resolve the issue of patients waiting for a lontime to get an appointment as huge patient turnouts make the waiting queues very long, extending the availability of a doctor upto 2 months. This becomes even more difficult for patients who travel from different parts of the country to seek medical care. Using the technology patients can get an appointment with all departments, from their homes. Currently, the solution is envisaged to be available in 14 Indian regional languages and will be extended to other Asian languages to facilitate patients from other countries.   ]]> https://biospectrumindia.com/news/97/4353/fda-approval-for-boston-scientifics-cardiac-device.html https://biospectrumindia.com/news/97/4353/fda-approval-for-boston-scientifics-cardiac-device.html Wed, 18 Mar 2015 12:23:07 +0530 Boston Scientific has received US Food and Drug Administration (US FDA) approval for the WATCHMAN, a left atrial appendage closure device. The WATCHMAN offers a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation,  who are seeking an alternative to long-term warfarin therapy. The device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation, who are at increased risk for stroke and systemic embolism, based on CHADS2 or CHA2DS2-VASc scores; are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device as compared to warfarin. The FDA approval is based on a robust WATCHMAN clinical program which consists of numerous studies with more than 2,400 patients and nearly 6,000 patients along with a number of years of follow-up. The WATCHMAN clinical program provided strong evidence that the device can be implanted safely and reduces the risk of stroke in eligible patients while enabling most patients to discontinue warfarin. Additionally, a meta-analysis of all of the randomized trial data demonstrated that while ischemic stroke reduction favored warfarin, the  device provided patients with a comparable protection against all-cause stroke and statistically superior reductions in hemorrhagic stroke, disabling stroke, and cardiovascular death compared to warfarin over long-term follow-up. "Today marks a defining moment in the company's journey towards establishing left atrial appendage closure therapy in the United States. Boston Scientific is proud to offer this potentially life-changing stroke risk treatment option to high-risk patients with AF who have a reason to seek a non-drug alternative to warfarin. This therapy could free them from the challenges of long-term warfarin therapy," said Mr Joe Fitzgerald, executive vice-president and president, rhythm management, Boston Scientific. He added, "FDA approval of the WATCHMAN device is another example of Boston Scientific delivering on its commitment to bring meaningful innovations to patient care."   The device has been commercially available internationally since 2009 and is the leading device in percutaneous left atrial appendage closure globally. It is registered in 75 countries and more than 10,000 patients have been treated with it.   ]]> https://biospectrumindia.com/features/97/4322/life-science-startups-across-iits-iims-other-incubation-centers.html https://biospectrumindia.com/features/97/4322/life-science-startups-across-iits-iims-other-incubation-centers.html Wed, 18 Mar 2015 09:40:00 +0530 IIT Delhi The Technology Business Incubator (TBI) has been in active operation in the institute since 2000. The TBI is conceived, programmed and implemented by the Foundation for Innovative and Technology Transfer (FITT), which is the Industry interface unit of the institute. Total Current Incubatees: 10 / Life Sciences: 4Total Graduated Incubatees: 30 / Life Sciences: 3Total Companies: 40 / Life Sciences: 7 IIT Mumbai Society for Innovation and Entrepreneurship (SINE) manages a technology business incubator at Indian Institute of Technology (IIT Mumbai). Set up in 2004, the incubator is a platform to support technology startups founded by IIT Mumbai community or are based on IIT Mumbai technologies.   Total Companies: 21 / Life Sciences: 2 IIT Madras IIT Madras Incubation Cell (IITM-IC) aims to coordinate, synergize and leverage the various strands of excellence driving innovation and entrepreneurship in a thriving ecosystem. Over 30 companies incubated. These ventures have been founded by students, faculty, staff and alumni of IITM and external members (R&D partners) across multiple sectors. Total Companies: 46 / Life Sciences: 8 IIT Hyderabad IIT Hyderabad incubator, known as the Centre for Innovation and Entrepreneurship (CIE) at IIT-Hyderabad, provides an ecosystem for technology commercialization and entrepreneurial action. Total Current Incubatees: 16 / Life Sciences: 2Total Graduated Incubatees: 30 / Life Sciences: 0Total Companies: 46 / Life Sciences: 2 IIT Kharagpur Technology Incubation and Entrepreneurship Training Society (TIETS) is a dynamic virtual incubation at IIT Kharagpur (KGP) for entrepreneurship development society. Total Companies: 26 / Life Sciences: 5 IIT Varanasi (BHU) Malaviya Centre for Innovation, Incubation and Entrepreneurship (MCIIE) is a not-for-profit society at IIT (BHU), dedicated to promote innovation and entrepreneurship. Total Current Incubatees: 08 / Life Sciences: 1Total Graduated Incubatees: 0 / Life Sciences: 0 IIT Guwahati Established in 2010, IITG-Technology Incubation Centre (IITG-TIC) goal is to encourage entrepreneurial initiatives amongst the faculty and alumni of the IITG community in particular and other State or Central Government Technical Institutions of the North East. Total Current Incubatees: 6 / Life Sciences: 1 IIT Roopnagar CIBI (Centre for Innovation and Business Incubation) matured out of IIT Roopnagar's small step of setting up an entrepreneurship cell (E-Cell) in 2010. Students and faculty members actively explore the possibilities of setting up ventures based on their own technologies and ideas. CIBI came into existence in 2013. Total Current Incubatees: 2 / Life Sciences: 0 IIT Kanpur SIDBI Innovation & Incubation Centre (SIIC) at IIT Kanpur was set up in collaboration with Small Industries Development Bank of India (SIDBI) to foster innovation, research and entrepreneurial activities in technology related areas. Established in 2000 with the vision of transforming knowledge into wealth, and creating a generation of zealous entrepreneurs. Total Current Incubatees: 24 / Life Sciences: 3 Indian Angel Network IAN in an equity based business incubator center that gives priority to ventures in the areas of healthcare, gaming and animation cloud computing, retail, mobile VAS, media and entertainment, alternative energy, education and clean technology. It has been established with the support of the National Science & Technology Entrepreneurship Development Board and the Department of Science & Technology of the Government of India. Total Companies: 37 / Life Sciences: 2 GSF M-Accelerator Started in 2012, GSF M-Accelerator is a specialized accelerator program for mobile startups. Functioning as a 'super-accelerator' by design, GSF M-Accelerator offers founders four months to make the kind of progress ordinarily accomplished in six to eight months.  Total Companies: 36 / Life Sciences: 1 Startup Oasis Startup Oasis is a Jaipur-based incubation centre set-up at the joint initiative of RIICO, Rajasthan's premiere industrial promotion organization, and the Centre for Innovation, Incubation and Entrepreneurship (CIIE) at IIM Ahmedabad. Total Companies: 43 / Life Sciences: 1 Venture Center (Pune) The BioIncubator at Venture Center aims to nucleate and nurture technology and knowledge-based enterprises leveraging knowledge in the areas of biotechnology (biopharma, agrobiotech, industrial biotech, and clean technology), biomedical engineering/ devices/ diagnostics, biomass value addition/ renewable fuels/chemicals/materials, bioinformatics, bio/medical services and related disciplines. Total Companies: 24 / Life Sciences: 24 NCL Innovations NCL Innovations was founded on 19 February 2007 as a new resource center of the National Chemical Laboratory, Pune to champion the cause of technology innovations within the organization. Total Companies: 5 / Life Sciences: 2 IIM Ahmedabad Aarohan Ventures is an early stage venture fund and incubator focused on building scalable education, healthcare and technology for development solutions. Aarohan supports social enterprises through seed funding, mentoring, grassroot support through partners, investment and strategic advisory by leveraging the IIMA community. Total Companies: 8 / Life Sciences: 2 IIM Calcutta IIM Calcutta Innovation Park (IIP), was set up under the aegis of the Centre for Entrepreneurship and Innovation (CEI) to incubate and accelerate the growth of start-ups in India. Total Companies: 5 / Life Sciences: 2 IIM Bangalore Set up in March 2002 as a focal point for entrepreneurial studies at IIM Bangalore, the Nadathur S Raghavan Centre for Entrepreneurial Learning (NSRCEL) facilitates business growth through academic research by scholars and practical learning for entrepreneurs. Total Current Incubatees: 8 / Life Sciences: 0Total Graduated Incubatees: 32 / Life Sciences: 1Total Companies: 40 / Life Sciences: 1 IIM Lucknow The Entrepreneurship cell of IIM Lucknow consists of students of IIM Lucknow committed to fostering entrepreneurial spirit among the students. It is considered to be a platform in terms of seed-funding, incubation, mentoring, training, knowledge dissemination and best practice research to convert path-breaking business ideas into self-sustaining business ventures. Total Companies: 2  / Life Sciences: 0 ]]> https://biospectrumindia.com/news/97/3989/chhattisgarh-plans-to-set-up-startup-village.html https://biospectrumindia.com/news/97/3989/chhattisgarh-plans-to-set-up-startup-village.html Tue, 17 Mar 2015 10:46:32 +0530 Chhattisgarh government officials recently visited the Kochi-based Startup Village to explore the incubation facility in order to establish a similar startup village in Chhattisgarh. Earlier the government of Andhra Pradesh and Madhya Pradesh expressed their desire in exploring the Startup Village. The Chhattisgarh officials were led by Mr Rajat Kumar, joint secretary to Chhattisgarh CM, who conducted discussions with officials at the incubation centre. ]]> https://biospectrumindia.com/news/97/3896/fda-issues-guidelines-for-reusable-medical-devices.html https://biospectrumindia.com/news/97/3896/fda-issues-guidelines-for-reusable-medical-devices.html Mon, 16 Mar 2015 14:46:00 +0530 The US Food and Drug Administration (US FDA) has announced new actions to enhance the safety of reusable medical devices. The FDA's guidance document, titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling",  includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices. As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer's reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users. The guidance lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions. It also recommends that manufacturers consider reprocessing challenges early in device design. Manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination. "Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low," said Dr William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. He added, "This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective."   The final guidance provides more clarity about testing protocols and data needs to  be submitted to the agency for a pre-market submission.   ]]> https://biospectrumindia.com/news/97/3758/toshiba-adds-new-products-to-its-portfolio.html https://biospectrumindia.com/news/97/3758/toshiba-adds-new-products-to-its-portfolio.html Mon, 16 Mar 2015 12:18:00 +0530 Toshiba America Medical Systems has launched new Aplio Platinum Series CV ultrasound systems. These include the Aplio 500 Platinum CV and Aplio 300 Platinum feature 2D Wall Motion Tracking, spectral and color Doppler, and Toshiba's latest suite of guidance and workflow technologies. According to Dr Edmund K Kerut, West Jefferson Medical Center, "Toshiba's Aplio 500 Platinum CV with Wall Motion Tracking technology delivers the image quality and data we need for quantitative measurements. It has made it easier to perform calculations of LV volumes with ejection fraction and serial follow-up of our chemotherapy patients with added GLS measurements." Also, the company's Infinix 4DCT has received US FDA (United States Food and Drug Administration) clearance with the Aquilion PRIME CT system configuration. The system significantly improves workflow with its SUREGuidance technology, which allows for automatic transition between modalities. In addition, it is capable of saving significant time by allowing clinicians to perform CT and interventional procedures within the same room and verify treatment success following procedures. "The Infinix 4DCT allows clinicians to plan, treat and verify in a single clinical setting, which negates the need to transfer patients between departments, resulting in anticipated decreases of both procedure time and risk of infection. This also contributes to improved patient safety and satisfaction by minimizing the clinicians' time spent away from patients, allowing them to focus on providing quality care," said Mr Bill Newsom, director, X-ray Vascular Business Unit, Toshiba.   Toshiba will showcase the Aplio Platinum Series CV and Infinix 4DCT at this year's American College of Cardiology (ACC) annual meeting.   ]]> https://biospectrumindia.com/news/97/3796/government-to-boost-telemedicine.html https://biospectrumindia.com/news/97/3796/government-to-boost-telemedicine.html Mon, 16 Mar 2015 12:10:59 +0530 To address the problem of scarcity of doctors in rural India, the Union Health Ministry will soon establish a National Medical College Network (NMCN). In NMCN, all the government medical colleges will be interlinked to create a national task force on tele-medicine. In the first phase, 41 government medical institutions will be interlinked to enhance technical education skills and provide outreach services or tertiary care services to peripheral health facilites. "Tele-Medicine centers will be established in these medical colleges which will also facilitate online consultation, expert care and follow up to remote centers whereever tele-medicine facilities exist. People in the rural parts of the country will be highly benefited," said Mr Navneet Kumar Dhamija, deputy commissioner, e-health at the Health Ministry, in a statement. Over 2.5 lakh villages will be benefited through the tele-medicine network.     ]]> https://biospectrumindia.com/news/97/5047/a-satellite-for-cancer-diagnosis.html https://biospectrumindia.com/news/97/5047/a-satellite-for-cancer-diagnosis.html Sat, 14 Mar 2015 10:05:00 +0530 The digital infrared sensor from European Space Agency (ESAs) Proba-V vegetation-scanning satellite is being adapted for several non-space applications. Mounted on a standard medical scanner, the space sensor can help doctors to look deeper into human tissues for detecting skin diseases earlier. Developed for ESA by the Belgian company Xenics, the camera has a unique wide field of view. Proba-V can detect shortwave radiation human eyes cannot detect. "To humans, two green trees could look similar. But with this camera, we might detect that one is growing well and the other is unhealthy," explains ESA's Mr Michael Francois. With support from ESA and the Belgian Space Technology Transfer Programme, the Xenics team created 'Machine Vision', integrating cameras on inspection systems. "The high-speed resolution of our line-scan cameras makes them ideal for detecting hidden defects on fast-moving production lines, such as bottle manufacturing or sorting different types of plastics for recycling, all of which look similar to the human eye," explains Mr Koen van der Zanden from Xenics.       ]]> https://biospectrumindia.com/news/97/6482/biogen-explores-wearables-to-track-patient-activity.html https://biospectrumindia.com/news/97/6482/biogen-explores-wearables-to-track-patient-activity.html Sat, 14 Mar 2015 09:30:00 +0530 Biogen (BIIB) is discovering ways to use fitness trackers to gather data from people who suffer from multiple sclerosis (MS). It recently completed a study of 250 patients in collaboration with PatientsLikeMe. The study reflects both the hope and current shortcomings of digital health at the moment. "Impaired mobility affects more than 90 percent of people with MS, but the quantified assessment of their walking ability tends to be limited to clinical settings. Sensors could give physicians a more accurate assessment of the level of activity of these patients if they were willing to wear activity trackers between appointments," said Ms Naomi Fried, vice-president of medial information and innovation at Biogen in a statement. According to the company, "The initial takeaway from the study is that it needs to use devices with more sophisticated sensors to quantify movement accurately and consistently. Current technology is not built to provide consistent and validated data in MS. We are early in the process, but hope to have progress in the coming months." The data from the study will be presented at the American Academy of Neurology's annual meeting next month.     ]]> https://biospectrumindia.com/news/97/6515/biomedical-systems-launches-next-generation-ecoa-technology.html https://biospectrumindia.com/news/97/6515/biomedical-systems-launches-next-generation-ecoa-technology.html Sat, 14 Mar 2015 09:13:00 +0530 Biomedical Systems launches its second generation clinical outcome assessment software offering three easy-to-use platforms to collect patient data. This new electronic patient recorded outcome (ePRO) technology improves patient and investigator user experience, improves patient compliance and expedites study setup by simplifying site tasks and reducing errors. Biomedical Systems' electronic clinical outcome assessment (eCOA) technology is used for clinical trials in more than 40 countries for multiple therapeutic areas including respiratory, gastrointestinal, dermatology, oncology and women's health. "The eCOA market is growing fast, and launching this technology enhances our ability to offer centralized diagnostic services. In 40 years, Biomedical Systems has built a premier global presence based on centralized diagnostic services and logistics excellence. Our eCOA solutions will extend that prompt, reliable global service we're known for to provide more reliable data while collecting data for primary and secondary endpoints," said Mr Tim Barrett, chief executive officer at Biomedical Systems.     ]]> https://biospectrumindia.com/news/97/5228/now-a-mobile-app-for-medicines.html https://biospectrumindia.com/news/97/5228/now-a-mobile-app-for-medicines.html Fri, 13 Mar 2015 12:21:32 +0530 Government is planning a mobile application that will provide all information related to pricing and availability of medicines as well as addressing consumer grievances, as per reports. "There are also plans to come up with a mobile application, which provides all information related to prices and availability of medicines and at the same time make the consumers aware about spurious medicines," said Fertiliser Minister Mr Ananth Kumar, in a statement. He further mentioned that the government is committed to regulating the prices of medicines that are on the National List of Essential Medicines. The minister inaugurated a web portal 'Pharma Jan Samadhan', a web portal for consumer grievances related to pricing and availability of medicines. "The National Pharma Pricing Authority (NPPA) has been searching for a weapon against black marketing and spurious medicines, and this portal will help them in that endeavor," said Mr Kumar.     ]]> https://biospectrumindia.com/news/97/4244/ventureast-invests-4-mn-in-diabetomics.html https://biospectrumindia.com/news/97/4244/ventureast-invests-4-mn-in-diabetomics.html Fri, 13 Mar 2015 12:20:26 +0530 DiabetOmics is the world's first company to develop a patented non-invasive, saliva-based glucose monitoring test for diabetes patients and an early detection test for gestational diabetes (in pregnant women) and pre-eclampsia (high blood pressure in pregnant women). The investment will be used to advance product development, obtain regulatory approvals in EU, USA and in emerging markets, set up manufacturing facility in India and begin commercialization. The company plans to obtain CE Mark in the second half of 2015, and commence commercialization in India and several other countries in early 2016. Mr Srinivasa Nagalla, president & CEO, DiabetOmics, commented, "India has earned the dubious distinction of being the diabetes capital of the world. Lack of patient compliance with regular glucose monitoring is the primary cause of diabetes-related complications. Our portable, easy-to-use device helps patients and their physicians stay informed of the status of the disease. We are extremely pleased with the investment we have received from Ventureast. We are looking to grow our presence in India to access Indian and SE-Asian markets." Ventureast's Life Fund focuses on investments in cleantech, food & agriculture, and healthcare sectors.   Then fund has previously made cross-border deals in drug discovery, medical devices, diagnostics, biotechnology and healthcare delivery. Mr Venkatadri Bobba, general partner, Ventureast, opined, "An important focus area for us has been investing in companies fostering cutting-edge and breakthrough innovations in healthcare. We believe that DiabetOmics' device is a game-changer and will definitely be successful in India." ]]> https://biospectrumindia.com/news/97/5285/mapmygenome-raises-pre-series-a-funding.html https://biospectrumindia.com/news/97/5285/mapmygenome-raises-pre-series-a-funding.html Fri, 13 Mar 2015 11:41:21 +0530 Mapmygenome have raised a Pre Series A round of funding from multiple sources including several entrepreneurs and angel investors. The list of investors include names like Ms Aarti Grover, MD-CMS Computers, Mr Rajan Anandan, MD-Google India, Mr Arihant Patni, MD-Hive Technologies and Mr Satveer Singh Thakral,CEO-Singapore Angel Network among others. Avendus Wealth Management, a subsidiary of Avendus Capital were the advisors for this round. Ms Anu Acharya, CEO, Mapmygenome, said, that the funding will help in scaling up in India and globally. "This round of funding will help in scaling up our operations in India and globally. We are looking to expand our team (Leadership, Sales and marketing and genetic counseling network) where our focus is on quality of talent education and expertise. We are also looking to invest in some assets and scale up our research." "As India's economy develops, we strongly believe that preventive healthcare will form a rising share of the household budget. Genome mapping is at the frontier of technological innovation in this context, and we are backing this experienced team to scale and make this technology commercially available to people from all walks of life who are pro-active about their health," said Mr Satveer Singh Thakral, CEO Singapore Angel Network.     ]]> https://biospectrumindia.com/news/97/6715/bioline-launches-rna-purification-kits.html https://biospectrumindia.com/news/97/6715/bioline-launches-rna-purification-kits.html Fri, 13 Mar 2015 09:10:00 +0530 Bioline has launched five kits in the high performance ISOLATE II nucleic acid purification range, ISOLATE II miRNA, Plant miRNA, Biofluids RNA, RNA/DNA/Protein, and FFPE RNA/DNA Kits. Bioline ISOLATE II Purification Kits are designed for rapid, phenol-free isolation of highest quality nucleic acids, including miRNA, even from samples that are difficult to process. All five kits offer significantly improved and unbiased recovery of small RNA molecules including miRNA and siRNA, to give highly accurate results. The new kits also efficiently purify high quality large RNA species such as mRNA. Mr Marco Calzavara, president of Bioline said, "With the additional five kits to the ISOLATE II nucleic acid purification range, researchers can achieve the purity and yield necessary for unbiased cDNA synthesis, high performance real-time RT-PCR and highly accurate RNA sequencing. This makes ISOLATE II the perfect starting point for a wide array of downstream applications including miRNA expression profiling and quantification, biomarker discovery, viral screening, pathogen detection, and agribiotech research." The five new ISOLATE II miRNA and RNA Purification Kits are available for a wide range of starting samples and tissue types.   ]]> https://biospectrumindia.com/news/97/6487/phenomenex-announces-winners-of-humanity-in-science-award-.html https://biospectrumindia.com/news/97/6487/phenomenex-announces-winners-of-humanity-in-science-award-.html Thu, 12 Mar 2015 15:30:55 +0530 Phenomenex along with The Analytical Scientist has announced the inaugural winners of the 2015 Humanity in Science Award. The winners are Dr Peter H Seeberger and Dr Andreas Seidel-Morgenstern of the Max-Planck Institutes in Potsdam and Magdeburg, Germany for their groundbreaking work on antimalarial drugs. "It has been such a pleasure for us to discover the incredible contributions to humanity by so many analytical scientists around the world. Scientists are humble people and, often, their work goes without publicity. We are so pleased to bring light to this amazing life-saving work and to honor our deserving winners with the grand prize," said Mr Fasha Mahjoor, president and CEO of Phenomenex. Mr Seeberger and Mr Seidel-Morgenstern's winning essay is titled, "Continuous Flow Production and Purification of Malaria Medications" which allows for cheaper antimalarial medications to be produced. According to the World Health Organization (WHO), around 584,000 people died from malaria in 2013; 90 percent of deaths were in Africa. The most effective drugs to treat malaria are artemisinin combination therapies (ACTs), which are expensive - and prone to counterfeiting. Up to 50 percent of ACTs in Africa and Asia are counterfeit. By coupling flow chemistry with advanced chromatography methods, Mr Seeberger and Mr Seidel-Morgenstern discovered that ACTs can be produced from plant waste material, air, and light. The new process, currently being implemented in a pilot plant in Vietnam, produces an active pharmaceutical ingredient with an HPLC purity of greater than 99.5 percent, which meets the standards set by the FDA and WHO. "We were all overwhelmed by the quality of the entries received for the Humanity in Science Award. The judging process was no easy task - and that's why we invited an international team of thought leaders to assess the entries. I am happy to report, however, that each and every judge was happy with the outcome. We all offer our congratulations to the winners but also to the runners up. I truly hope that this annual award serves its singular purpose - to shine the spotlight on the great work of analytical scientists around the world," said Mr Rich Whitworth, editor, The Analytical Scientist.   The winners will receive $25,000 in prize money and their essay will be published in The Analytical Scientist magazine in 2015 in print and online. "This recognition of our work by an international jury of leading scientists encourages me to continue our work on translating our scientific breakthrough into a production facility. Thereby, those in need of malaria medications will benefit from better access and lower prices while the dangers of fake medications are reduced. This process is just one example of the power of continuous processes that will revolutionize the production of life-saving medications in developing countries," said Dr Seeberger.       ]]> https://biospectrumindia.com/news/97/6747/eppendorf-introduces-two-new-products.html https://biospectrumindia.com/news/97/6747/eppendorf-introduces-two-new-products.html Thu, 12 Mar 2015 14:10:08 +0530 Eppendorf has added new products to its portfolio. Its HeatSealer family offers two new devices for reliable sealing of different plate formats. The customers can choose between a small and extremely user-friendly device, HeatSealer S100, and a slightly bigger version, HeatSealer S200, with flexible programmable sealing parameters. Both models allow for easy, reproducible and effective sealing of plates, thereby efficiently preventing evaporation and contamination. "A reliable assay result can only be achieved with plates that are reproducibly and tightly sealed. This also applies to the storage of samples. Especially for long-term storage, tight sealing is crucial for save storage of your sample until you need it again," said Dr Kay Körner, senior global product manager, PCR, Eppendorf. The company also broaden the volume range of Eppendorf Tubes with the launch of new Conical tubes, 15 mL and 50 mL. With the introduction of the two screw cap tubes 15 mL and 50 mL, Eppendorf Tubes now cover the entire volume range from 0.5 mL to 50 mL. The newly designed screw caps provide not only optimal sealing properties, but with their grooved and multi-surface side-contour they simultaneously ensure a secure, slip-free grip. The optimized handling features further facilitate safe opening and closing of the tubes via convenient one-handed operation.   The Eppendorf Conical Tubes are further characterized by an expanded purity grade, they are not only sterile and pyrogen-free, but they are also free from DNases and RNases as well as human and bacterial DNA. These features make them ideally suited for cell biology applications in a sterile environment as well as for laboratory protocols in the fields of microbiology and molecular biology, which rely on freedom from contaminations with DNA. The highest level of manufacturing precision and robustness ensure smooth performance of these tubes in laboratory instruments such as centrifuges or thermomixers. "With all these high quality product features, the Eppendorf Conical Tubes 15 mL and 50 mL make a significant contribution to reliable and reproducible results in a broad variety of laboratory protocols," said Dr Nils Gerke, global product manager for Consumables at Eppendorf.     ]]> https://biospectrumindia.com/news/97/6738/micron-extends-clinical-trial-imaging-services-outside-japan-.html https://biospectrumindia.com/news/97/6738/micron-extends-clinical-trial-imaging-services-outside-japan-.html Thu, 12 Mar 2015 14:05:00 +0530 Singapore: VirtualScopics, a US-based provider of clinical trial imaging solutions, IXICO plc, European brain health company, and Japanese company, Micron that provides imaging services for clinical trials in Asia jointly announced that they have entered into a collaboration agreement enhancing each company's global clinical trial imaging solution offerings to Pharma and Biopharma companies. This collaboration agreement will now allow Micron to expand its services outside of Japan to the markets of North America and Europe. Micron has established an environment to implement many multicentre imaging clinical trials, especially in Asian countries, such as Japan and Korea. Under this comprehensive collaboration with VirtualScopics and IXICO, Micron will be able to broaden its services to handle multinational, multicentre clinical trials beyond Asia, including Europe and the US and expand its analysis services in the field of oncology and neuroscience. ]]> https://biospectrumindia.com/news/97/6725/8k-miles-buys-cro-software-startup-mindprint-to-foray-into-pharma-biz-.html https://biospectrumindia.com/news/97/6725/8k-miles-buys-cro-software-startup-mindprint-to-foray-into-pharma-biz-.html Thu, 12 Mar 2015 12:52:00 +0530 8K Miles, headquartered in the San Francisco and with Indian operations in Chennai, has entered into an asset purchase agreement with Mindprint Inc., a Canada-based clinical research software startup focused on analytics and operational software for Clinical Research Organizations (CROs) and pharmaceutical sponsors. This agreement includes acquisitions of intellectual property, client contracts and employees. The acquisition has been made through by 8K Miles' US-based subsidiary, 8K Miles Software Services Inc and it involves $1,50,000 in cash and $2,50,000 in stock. The total consideration in cash and stock, for the acquisition is $400,000. The transaction is expected to be completed before 31st March 2015. 8K Miles is India's only BSE listed cloud solutions provider and its cloud computing solutions are offered to large enterprise customers in healthcare, pharmaceutical, financial and insurance verticals whose primary focus is on security and compliance. Mindprint's deep domain knowledge of CRO and pharmaceutical outsourcing operations provides 8K Miles with additional competitive advantage for successfully entering into the CRO market and capitalize on its expertise. Global CROs use Mindprint SaaS analytics and operational software to gain valuable insights into their profitability, resource utilization, study progress and forecasts. Mindprint has announced multiple highly successful client implementations of their SaaS software systems ranging from small to mid-size CROs. Mindprint has partnered with a number of leading CROs and understands the life cycle of a clinical study as well as the business challenges unique to the life sciences industry. With this acquisition, Prasad A Sristi, President of Mindprint Inc. will take on the role as VP, Product Management and Business Development at 8K Miles. ]]> https://biospectrumindia.com/interviews/97/6502/mobility-solutions-is-the-most-inexpensive-way-to-provide-quality-healthcare-.html https://biospectrumindia.com/interviews/97/6502/mobility-solutions-is-the-most-inexpensive-way-to-provide-quality-healthcare-.html Wed, 11 Mar 2015 11:47:00 +0530 Could you please give a brief introduction about American Megatrends India Pvt Ltd and its business in healthcare solutions? American Megatrends India Pvt Ltd (AMI) is a leader in high-tech engineering and computing innovations worldwide. AMI has more than 200 patents awarded globally on innovative engineering solutions and AMI products are shipping in more than half a billion of computers in the world today. AMI are specialty leaders in embedded services, BIOS customization and porting, mobility solutions, IP SAN/NAS Data storage solutions, Infrastructure Asset Management, Telematics Solutions, Knowledge Management System, Healthcare IT solutions, Platform Validation Services and Android Services. At AMI, we promote 'Prevention is better than Cure' and we firmly believe in it. Our healthcare products and services are designed to bring awareness of individual's health to palm of their hands. Our lifestyle products AMI B.O.L.T and AMI VitalsFit are designed to address these requirements by supporting individuals to measure the key health parameters in comfort of their homes. The ability to maintain trends and share the health records instantaneously with quality healthcare providers makes our solution unique and first of its kind. AMI's VitalsFit is the only Indian entrant for the Qualcomm Tricorder XPRIZE, which is quite an accomplishment. How was this planned and achieved? Even before we came to know of this competition, AMI had an internal team working on a solution similar to this to meet the key supply-demand challenges of the current healthcare system. Currently, telemedicine systems are restricted to video conferencing facility between patients and care givers. It does not address the importance of sharing key health parameters with care providers. Also, the healthcare is more oriented towards cure and symptom-based diagnosis than prevention.   In today's scenario many of the individuals do not know that they have a chronic condition, till the condition develops into a disease or organ damage. Many souls have departed us with out knowing what has happened to their health in their primes. We wanted to put a stop to this and find a solution for it. Hence, we felt the need of developing quality healthcare devices that could be a 'lifetime companion' and could be used by any individual to know the status of their health and share it with care givers for affordable, reliable and quality healthcare. We came to know of XPrize competition through Linked-in. Once we knew that Xprize is involved, we got the affirmation that we are on the right track and got ourselves enrolled into the competition. We believe the success we achieved so far is because of the conviction we have as a team that we could do something to better the healthcare system and bring quality care to individuals to live their life to fullest without compromises made. Do you believe that your product can beat 9 other competitors and win the XPRIZE in 2016? As stated earlier, we didn't join the competition to beat the other competitors. Our intention is to change the healthcare system from 'Cure and Symptom' based to 'Prevention'. Involvement with XPrize helps us to accomplish this mission. All the top ten finalists are working hard to bring a positive change to this field. For us, the success is marked by the day when we have positively impacted the healthcare system and increased the life span of and individual at least by a day with healthy and happy life. AMI is working on portable life companion healthcare gadgets. Could you elaborate on how such gadgets can change the trend in future healthcare management? Today, we go see a healthcare professional when we get sick. By the time we consult a healthcare professional, the sickness would have gone worse because of chronic conditions. Chronic conditions like hypertension, blood sugar, cancer and many others don't show any symptoms. They are known as 'Silent Killers' as their presence is not signified by any symptoms until the time the complications have reached to the level of organ failure. To detect the susceptibility to chronic conditions, one should regular monitor their vitals like BP, Blood Sugar, SPO2, Respiration rate and others, to check whether they are within the optimal range. If consistent abnormality is detected, once should immediately consult a qualified caregiver to bring health back on track. Many of the chronic conditions could be avoided by making small changes to lifestyle habits. Our portable gadgets are aimed to be a lifestyle companion that would help individuals to keep track of their health. Our health tracker would help individuals to record their key vitals regularly in the comfort of their homes. With trend data, it could analyze the susceptibility to chronic conditions and let the individuals on the health status to take informed decisions. The goal of our healthcare solutions is to put the control of the health in individual's hands. What would be your GO TO market strategy for the product after complete development? To have a quality healthcare system both individuals and experts should have access to health data with the consent of the individual for better care. Hence, our solution links individuals with caregivers and professionals for preventive, quality and affordable healthcare. We are partnering with several healthcare providers across the globe to have our product available as a packaged healthcare solution with caregiver's integrated services. Many of our products would be white-labeled with caregivers' brand and their integrated services. What is your take about mobility solutions in healthcare and how do you perceive its future especially in India? India has close to 800 million living in rural areas compared to only 400 million in urban. The doctor to patient ratio is way skewed and availability of specialists and quality care providers are limited. Interestingly, mobile penetration in India is very high and it is across the country. Slowly smartphone penetration is also increasing. With Government initiatives of fiber-connectivity across villages is going to help India digitally connected and aid digital revolution. Hence, connectivity and reach would become a mute issue. However, the last mile of collecting the right data and sharing with the quality care providers would become the need of the day. Definitely, mobility is the way to go and it is the inexpensive way to provide quality healthcare. Today, a mobile comes with all the elements required for audio/visual communication and transmission. Companion portable devices like AMI B.O.L.T and AMI VitalsFit extends the value of the smartphone by taking the quality healthcare to doorsteps of the individuals. The health parameters are not only accurately collected but it is instantaneously transmitted to the caregiver for quality care. What would be the revenue generated by AMI's healthcare business? The estimated medical devices market in India is around $3bn and is growing at CAGR of 15%. We are expecting a decent share of the market over the years. Are there any plans to collaborate with other healthcare IT companies? Yes, we do. We are partnering with key healthcare providers and many of our products would be integrated with their services and to be made available in the market. ]]> https://biospectrumindia.com/news/97/6486/illumina-merck-collaborate-in-cancer-diagnostics.html https://biospectrumindia.com/news/97/6486/illumina-merck-collaborate-in-cancer-diagnostics.html Wed, 11 Mar 2015 11:41:38 +0530 Illumina has announced its collaboration with Merck to develop a universal next-generation sequencing (NGS)-based oncology diagnostic. Both the companies will work to create a universal test system for clinical trials of targeted cancer therapies, with the goal of a more comprehensive tool for precision medicine. Illumina is working with Merck Serono to develop assays that detect and measure multiple variants simultaneously to support clinical trials. The collaboration toward the universal cancer test will include test development, worldwide regulatory approvals, and global commercialization. In parallel, Illumina continues to collaborate with the key thought leaders of the Actionable Genome Consortium to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. "Our collaboration with Illumina around next-generation sequencing will enable us to perform genome studies at a pace unheard of a few years ago, and could lead to the development of several diagnostics," said Ms Susan Herbert, head of global business development at Merck. She added, "This collaboration will strengthen the position of Merck Serono as a global leader in precision medicine in oncology." "This agreement is another step forward in realizing the promise of precision medicine," said Dr Richard Klausner, Illumina's chief medical officer. He added, "The US government's Precision Medicine Initiative, recently announced by President Obama, specifically outlines the need to expand genetically-based clinical trials as a key approach for developing better treatments for cancer. We are very excited to work with Merck Serono on this endeavor."   ]]> https://biospectrumindia.com/news/97/5043/icon-launches-medtech-research-group.html https://biospectrumindia.com/news/97/5043/icon-launches-medtech-research-group.html Wed, 11 Mar 2015 09:08:00 +0530 ICON has announced the launch of a new Medical Device and Diagnostics Research group,  focused on the unique requirements of the medical device and diagnostics industry. The new group combines the medical and regulatory device and diagnostic expertise of Aptiv Solutions, which ICON acquired in 2014, with ICON's global clinical development and commercialisations solutions. Device and diagnostic manufacturers can now benefit from an expanded suite of services that support the full product lifecycle, including global clinical trial execution, health economics and pricing and market access solutions. "The device and diagnostic development model can differ significantly from that of pharmaceutical companies, both in complexity and time to market," said Ms Elizabeth Thiele, president, ICON commercialisation and Outcomes. She added, "Operating under specific medical device SOPs and ISO certification, our new Medical Device & Diagnostics Research team has the expertise and flexibility to help manufacturers take time and cost from their development programmes and maximise the value of their products." ICON's Medical Device and Diagnostics Research group will be led by Mr Vicki Anastasi, vice-president, Medical Device and Diagnostic Research who has over 20 years of experience in the field.   ]]> https://biospectrumindia.com/news/97/6710/advanced-bionics-receives-ce-mark-approval-for-cochlear-implant-.html https://biospectrumindia.com/news/97/6710/advanced-bionics-receives-ce-mark-approval-for-cochlear-implant-.html Tue, 10 Mar 2015 11:38:34 +0530 Advanced Bionics (AB), has announced that the HiRes 90K Advantage cochlear implant with HiFocus 1J, HiFocus Helix, and HiFocus Mid-Scala electrodes, has received CE Mark approval from the European Notified Body, TÃœV, to be implanted in patients with unilateral (asymmetric) hearing loss, also known as single-sided deafness (SSD). "We are pleased that patients with single-sided deafness can now benefit from our cochlear implant technology," said Mr Hansjuerg Emch, president of Advanced Bionics. The newest AB electrode array, the HiFocus Mid-Scala electrode, was designed for optimal placement in the cochlea with low insertion force to protect its delicate structures, and promotes the latest soft surgery approaches to suit surgeon preferences. The HiFocus Mid-Scala offers recipients the opportunity to hear the most pitches possible for enjoying music and improved speech understanding.   ]]> https://biospectrumindia.com/news/97/7007/philips-partners-with-university-of-california.html https://biospectrumindia.com/news/97/7007/philips-partners-with-university-of-california.html Mon, 09 Mar 2015 12:49:04 +0530 Royal Philips has announced its collaboration with the University of California, Irvine. The deal is to explore how spectral breast imaging can improve breast density measurement, potentially aiding clinicians in more accurately gauging breast cancer risks and monitoring changes over time. The study will rely on Philips' MicroDose SI mammography spectral imaging technology. With MicroDose SI, Philips introduced its first spectral imaging application with a new feature called Spectral Breast Density Measurement. Rather than estimating density, the tool uses photon counting technology to simultaneously acquire spectral data of the adipose and fibro glandular tissue within a single exposure of a low dose mammogram. This provides an objective volumetric breast density measurement, paving the way for refined risk assessment and personalized care. The ability to more accurately measure breast density will enable radiologists to personalize breast cancer screenings and potentially be used for treatment monitoring. "Through this study, UC Irvine and Philips are looking to set an industry standard for objectively measuring breast density. While this doesn't exist today, it will be increasingly critical as we move toward further personalizing breast cancer screening, and enabling patients to become more engaged in their own care," said Mr Gene Saragnese, CEO Imaging, Philips. He added, "With the combination of our MicroDose SI technology and leading imaging experts at UC Irvine, we can determine if spectral breast imaging can help provide more definitive diagnoses, at low radiation dose, to better help patients and clinicians in the fight against breast cancer."   The first phase of the study will focus on assessing the accuracy of the spectral breast density application by analyzing 40 post-mortem breasts and comparing results with chemical analysis. The study is expected to be completed over a one- to two-year-long period.       ]]> https://biospectrumindia.com/news/97/6308/pens-with-bio-inks-can-detect-blood-sugar-levels.html https://biospectrumindia.com/news/97/6308/pens-with-bio-inks-can-detect-blood-sugar-levels.html Sat, 07 Mar 2015 11:00:00 +0530 In a new breakthrough, researchers at the University of California have determined that ballpoint pens filled with high-tech bio-inks can be used to detect blood sugar levels of patients. The study published in the journal Advanced Healthcare Materials elaborated that the team has developed high-tech bio-inks that react with several chemicals, including glucose. Scientists envision that the new system can be used for personalized and inexpensive health monitoring. "Our new biocatalytic pen technology, based on novel enzymatic inks, holds considerable promise for a broad range of applications on site and in the field," said Mr Joseph Wang, the chairman of the Department of NanoEngineering. As part of the study, the team pricked a subject's finger and put the blood sample on the sensor. The enzymatic ink reacted with glucose and the electrode recorded the measurement, which was transmitted to a glucose-measuring device. The team estimates that one pen contained enough ink to draw the equivalent of 500 high-fidelity glucose sensor strips. Researchers also said that the sensors can be used to react with many pollutants, including heavy metals or pesticides.     ]]> https://biospectrumindia.com/news/97/6087/toshiba-introduces-latest-additions-to-app-lite-family-for-iot-solutions.html https://biospectrumindia.com/news/97/6087/toshiba-introduces-latest-additions-to-app-lite-family-for-iot-solutions.html Sat, 07 Mar 2015 09:23:00 +0530 Toshiba Corporation has announced the launch of "TZ1031MBG" and "TZ1011MBG" application processors for wearable devices, as the latest additions to its ApP Lite family's TZ1000 series, to provide solutions for the Internet of Things (IoT). Last November, Toshiba launched the "TZ1001MBG"application processor, a single package that integrates sensors for data collecting, a processor for data processing, flash memory for data storage, and a Bluetooth Low Energy controller for data communication. Building on this, the new application processors expand sensing functionalities by adding a gyroscope to the "TZ1031MBG" and a gyroscope and magnetometer to the "TZ1011MBG". The high level integration of the new application processors makes it possible to realize wearable devices without any other components. It also contributes to a smaller form factor, which enables wearable devices to be reduced in size. The new processors are expressly designed for low power performance, essential for securing a longer battery life for wearable devices. Toshiba is expanding its line-up of systematic solutions for the TZ1000 series by developing software algorithms that can be applied to measuring weak biomedical signals, such as pulse and ECG. Meanwhile, Toshiba is providing an evaluation environment for developers to shorten the time to market for products integrating its application processors.   The new processor Integrates a wireless communication function, sensors, a memory and a processor in one package. It also has embedded ARM Cortex-M4F processor, High performance ARM Cortex-M4F with DSP and floating point processing unit allows combination of data from multiple sensors, both internal and external, to improve accuracy (sensor fusion), High resolution ADCs. The products integrate a 24-bit high resolution ΔΣADC with high speed switches connected to three input channels, so as to be capable of measuring weak biomedical signals, such as the pulse and the heart's electrical activity. It  also integrates Bluetooth wireless communication function.     ]]> https://biospectrumindia.com/news/97/3925/global-prosthetic-heart-valve-market-to-touch-4-46-bn-by-2020.html https://biospectrumindia.com/news/97/3925/global-prosthetic-heart-valve-market-to-touch-4-46-bn-by-2020.html Sat, 07 Mar 2015 09:08:00 +0530 This is driven by the rising prevalence of valvular heart disease, an aging population and technological advancements in the field of interventional cardiology, says GlobalData. The company's latest report states that across the 10 major markets, namely the US, France, Germany, Italy, Spain, UK, Japan, India, China and Brazil, expansion will occur fastest in Germany, at a Compound Annual Growth Rate (CAGR) of 16.6%, as the country spearheads the adoption of transcatheter aortic valve replacement (TAVR) devices. According to Mr Premdharan Meyyan, GlobalData's analyst covering medical devices, Germany is expected to see an increase in its transcatheter and tissue valve market value, while the mechanical valve market value is expected to decrease, thanks to a steady decline in the procedure volume for both mechanical aortic and mitral valve replacement. He commented, "Germany is the largest European market for prosthetic heart valves and is a leading center for technological innovation, home to early adopters of new and innovative devices. As such, TAVR cases in Germany are expected to increase rapidly because the country has historically been receptive to interventional products." Germany's overall prosthetic heart valve market is expected to grow in total value from just under $399 million in 2013 to around $1.16 billion by 2020, of which transcatheter heart valve replacements will constitute approximately $1 billion.   He continued, "The emergence of valve-in-valve procedures also serves as a significant market opportunity. Physicians are opting to use bioprosthetic valves because they are confident that in the case of tissue valve degeneration, they will be able to re-intervene and percutaneously implant a transcatheter valve." "Given the high treatment costs associated with TAVR, strict regulations have been implemented for this procedure. However, if the cost of this technology can be reduced, as is expected with the approval of next-generation devices, the German market will be the most lucrative for companies in this space," the analyst concluded. ]]> https://biospectrumindia.com/news/97/6603/ge-ventures-launches-new-digital-health-company.html https://biospectrumindia.com/news/97/6603/ge-ventures-launches-new-digital-health-company.html Fri, 06 Mar 2015 12:23:32 +0530 GE Ventures and Stanford Health Care has announced the launch of Evidation Health, an independent company committed to improving health outcomes with evidence-based digital medicine. Focused on generating real-world clinical and economic evidence for digital health products and platforms, Evidation Health combines health outcomes data with new approaches to predictive analytics to identify and deploy the most effective and efficient patient management strategies and interventions. Evidation Health CEO, Ms Deborah Kilpatrick, said, "Our company has the core capabilities to make precision digital medicine a reality. We envision a digital health-enabled future where clinical interventions can be customized and concentrated in ways that maximize clinical and economic benefit for payers, providers and, most importantly, patients." To accelerate commercial progress, Evidation Health joined forces with The Activity Exchange, a digital health company with strong predictive analytics capabilities, and closed its Series A financing in January of 2015. The round was led by GE Ventures, with participation from Asset Management Ventures and Rock Health. The company is focused on forging new partnerships while continuing its corporate and academic collaborations with Humana, Biogen, Sanofi, Harvard Business School and Wharton, amongst others. Stanford Health Care president and CEO Mr Amir Dan Rubin, said, "Stanford Health Care is committed to delivering integrated solutions to the complex problems patients face, and those solutions will increasingly be advanced through digital health. As an early adopter of electronic health records, virtual visits and precision health, Stanford Health Care is excited to join with GE Ventures to launch Evidation Health to provide real-world assessment and validation of digital health care technologies."       ]]> https://biospectrumindia.com/news/97/7248/no-late-age-trials-for-some-drugs.html https://biospectrumindia.com/news/97/7248/no-late-age-trials-for-some-drugs.html Fri, 06 Mar 2015 12:21:13 +0530 At a recent meeting of the Drugs Technical Advisory Board, a panel of advisors to the government that late-stage clinical trials be waived under certain conditions for some new drugs already being sold on international markets, says reports. The panel said that clinical trials for new drugs already selling in a well regulated country may be waived, if the safety and efficacy of the drug is found to be favourable. The evaluation of such new drugs should be made in consultation with experts on specific therapeutic areas, the panel advised. This would significantly speed up the approvals process for new drugs and will likely be cheered, chiefly by foreign drugmakers who have decried India's strict rules and red tape around clinical trial approvals.               ]]> https://biospectrumindia.com/news/97/6709/fujifilm-presents-a-synapse-cardiovascular-system.html https://biospectrumindia.com/news/97/6709/fujifilm-presents-a-synapse-cardiovascular-system.html Thu, 05 Mar 2015 12:36:43 +0530 FUJIFILM Medical Systems is all set to demonstrate next generation echocardiography structured reporting, with the latest version of Synapse Cardiovascular 6.0 and Synapse 3D 4.1 at the American College of Cardiology (ACC) 64th Annual Scientific Session and Expo. "Created in collaboration with cardiologists and cardiovascular specialists, the latest version of Synapse 3D and Synapse Cardiovascular provides users with essential tools without adding complexity," said Mr Jim Morgan, vice-president of Medical Informatics, FUJIFILM Medical Systems. He added, "With Synapse, our users are able to perform their job more efficiently and ultimately allow them to concentrate more on the patient and improve patient outcomes." Synapse Cardiovascular helps cardiologists in a variety of clinical areas and interpret images and compose structured reports with a streamlined workflow. The system has powerful capabilities designed specifically for, echocardiography, cardiac catheterization and invasive peripheral vascular, nuclear cardiology, vascular ultrasound, ECG management, CT, and Cardiac MRI workflows. Synapse 3D offers more than 30 clinical functions to choose from, with many functions utilizing Fujifilm's Image Intelligence capability. It is fully integrated with Synapse PACS and Synapse Cardiovascular, and creates a centralized enterprise-shared 3D solution.     ]]> https://biospectrumindia.com/news/97/7726/hospiras-vizag-plant-under-usfda-radar.html https://biospectrumindia.com/news/97/7726/hospiras-vizag-plant-under-usfda-radar.html Wed, 04 Mar 2015 12:48:45 +0530 On February 25, 2015, Hospira Healthcare India Private Limited (Hospira India), a subsidiary of Hospira, Inc., received a Form 483 from the FDA containing 14 observations relating to an inspection of Hospira India's pharmaceutical manufacturing facility nearing commercial operation in Visakhapatnam, India. The inspection was conducted over the period from February 16 through February 25, 2015. The company intends to respond fully and in a timely manner to the observations contained in the Form 483. There can be no assurance that the FDA will be satisfied with the company's response. The company must obtain the approval of the FDA in order to commercialize products produced at the Vizag facility. ]]> https://biospectrumindia.com/news/97/5078/perkinelmer-collaborates-with-johnson-johnson.html https://biospectrumindia.com/news/97/5078/perkinelmer-collaborates-with-johnson-johnson.html Wed, 04 Mar 2015 12:47:47 +0530 PerkinElmer has announced a collaboration with Johnson & Johnson Innovation to provide JLABS @South San Francisco (JLABS @SSF), a newly-opened lifescience incubator, with instruments and lab services to address the research needs of resident startups. PerkinElmer will also provide on-site staff, training and scientific application support as a new offering to JLABS residents. "It is critical that growing companies in the healthcare and scientific space have access to the most cutting-edge lab infrastructure, assets, application knowledge and support to help drive their research efforts," said Mr Jim Corbett, president, Human Health, PerkinElmer. He added, "We look forward to working together with Johnson & Johnson Innovation to identify and meet the research needs of entrepreneurs as they advance their science and make breakthrough discoveries." The collaboration will enable JLABS @SSF residents to perform a variety of research and development activities using PerkinElmer's advanced imaging and detection solutions for a wide range of lifesciences and environmental health applications. These include: sample preparation, protein characterization, screening new drugs, performing assays for drug discovery, mass spectrometry analysis, next-generation sequencing, identifying adulterants and contaminants, and forensics testing. PerkinElmer's OneSource Laboratory Services team of certified engineers and scientific staff will also provide on-site expertise and knowledge to assist the companies with their scientific processes.  ]]> https://biospectrumindia.com/news/97/5366/global-ultrasound-equipment-market-to-grow-steadily.html https://biospectrumindia.com/news/97/5366/global-ultrasound-equipment-market-to-grow-steadily.html Wed, 04 Mar 2015 12:45:45 +0530 The Global Ultrasound Equipment market to grow at a Compounded Annual Growth Rate (CAGR) of 5.79 percent over the period 2014-2019, according to a new report by research and markets. The Global Ultrasound Equipment market is divided into two segments based on product type: Portable Ultrasound Equipment and Static Ultrasound Equipment. An increase in the demand for portable ultrasound equipment is one of the key trends upcoming in the market. This equipment is more efficient and can be moved easily, unlike traditional ultrasound equipment. Many vendors are developing portable ultrasound equipment to increase their market shares. According to the report, increased use of ultrasound equipment is one of the major drivers of this market. Patients and healthcare professionals opt for minimally invasive procedures to diagnose chronic diseases as this equipment causes minimal to no pain and does not pose the risk of infection. Further, the report states that the complications involved in the use of 4D ultrasound imaging equipment is one of the major challenges that the market faces. Moreover, 4D ultrasound equipment is more expensive than 3D ultrasound equipment, and this affects their sales.       ]]> https://biospectrumindia.com/news/97/6705/ge-healthcare-introduces-latest-innovations-.html https://biospectrumindia.com/news/97/6705/ge-healthcare-introduces-latest-innovations-.html Wed, 04 Mar 2015 12:45:14 +0530 GE Healthcare has introduced its latest innovations for medical imaging and healthcare IT. The company introduces Revolution CT ultra-fast CT scanner, an ultra sound system LOGIQ P9, SIGNA MR, Discovery IGS 740, a mobile angiography system. GE Healthcare's Revolution CT is an ultra-fast CT scanner that allows clinicians to image the heart in just one heartbeat, freezing the heart's motion and delivering high image quality. The new LOGIQ P9, is a mid-range ultrasound system made easy for clinicians to use due to its large monitor, customizable touchscreen and simplified console design. SIGNA Explorer is equipped with GE Healthcare's revolutionary technology, SilentScan, significantly reducing noise levels to three decibels ambient for neurological exams. Discovery IGS 740 is a mobile angiography system that puts interventional radiologists at the centre of their procedures. Its unique mobile platform provides outstanding imaging flexibility.   The company also introduced Optima XR646, the new X-ray system.  GE Healthcare is also enabling collaborative care networks, helping transform care to become far more patient-centric; driving higher quality care by helping ensure the most appropriate expert is assigned to each case and improving productivity by reducing unnecessary travel between hospitals for clinicians. Mr Jean-Michel Malbrancq, president and CEO, GE Healthcare Europe said, "GE has been committed to innovating for radiologists and their patients for more than 100 years. We're delighted to be at ECR 2015, sharing a range of innovations all of which are designed to help solve the challenges faced by healthcare providers across Europe. Visitors to our booth will see that we're focused on new technologies that are designed to help our customers make more confident diagnoses, improve patient safety and comfort, increase throughput and generate efficiencies." The company launched these products at the 2015 European Congress of Radiology (ECR).   ]]> https://biospectrumindia.com/news/97/6702/-budget-a-big-blow-to-make-in-india-vision.html https://biospectrumindia.com/news/97/6702/-budget-a-big-blow-to-make-in-india-vision.html Wed, 04 Mar 2015 11:53:26 +0530 This budget completely overturns the 'Make in India' vision especially for medical devices, said Mr Rajiv Nath, forum coordinator, AIMED. He further added that nobody including MNCs will invest in 'Make in India' if it remains cheaper to import than to manufacture the same products here, accompanied by all the difficulties of setting up a production unit and running the business. He further suggested that the finance ministry and revenue department should work together with other stakeholder ministries like DIPP, DOP, DIETY, and DoC to drive domestic manufacturing of medical devices. "Very partial and negligible token relief has been provided on pace makers and endoscopes. There is nothing structural to drive manufacturing of Medical Devices in India or make domestic companies competitive and expand market share from below 20-30 percent. There are a few tweaks on the inverted duty structure but limited to only 2-3 items like Pacemakers and Endoscopes by 2.5 percent reduction in Raw Material costs! Reducing CVD makes imports competitive as manufactures can't set off Modvat on inputs. Even the Economic Survey recommended doing away with Excise Duty concessions as Indian companies loose out to imports," he added. Also, reduction of SAD is not going to help domestic manufacturing become more competitive.         ]]> https://biospectrumindia.com/news/97/6309/cardinal-health-to-acquire-jjs-cordis-business-unit.html https://biospectrumindia.com/news/97/6309/cardinal-health-to-acquire-jjs-cordis-business-unit.html Tue, 03 Mar 2015 12:07:31 +0530 Cardinal Health has announced that it will acquire Johnson & Johnson's (J&J) Cordis business, a manufacturer of cardiology and endovascular devices, for $1.944 billion in cash, or approximately $1.594 billion, net of the present value of tax benefits. The acquisition is expected to be financed with a combination of $1.0 billion in new senior unsecured notes and the remainder with existing cash. "We are extremely excited about the acquisition of Cordis. This is a significant step forward in our cardiovascular strategy. Cordis brings with it a long and proud legacy of cardiovascular innovation. This move highlights our commitment to address a major pain point in healthcare systems through innovative new approaches to the management of physician preference items,"  said Mr George Barrett, chairman and CEO, Cardinal Health. He added, "This acquisition follows a sequence of strategic moves for Cardinal Health in the areas of cardiology, wound management and orthopedics. We are well-positioned to help customers standardize around mature medical devices, while bringing them innovative solutions around supply chain management, inventory optimization, and work flow tools and data to support the most effective management of the patient." Once the transaction is complete, the business will report to Mr Don Casey, Cardinal Health's Medical Segment chief executive officer. "We look forward to drawing heavily on the knowledge and innovative spirit of Cordis team members around the world. Additionally, Cordis' global expertise and footprint provide an exciting opportunity to leverage scale in sourcing and manufacturing," said Mr Casey. The transaction is expected to close in the United States and key non-US countries towards the end of calendar 2015. The company expects the acquisition to be increasingly accretive thereafter and assumes that synergies will exceed $100 million annually by the end of fiscal 2018.       ]]> https://biospectrumindia.com/news/97/5186/icon-completes-acquisition-of-medimedia-pharma-.html https://biospectrumindia.com/news/97/5186/icon-completes-acquisition-of-medimedia-pharma-.html Tue, 03 Mar 2015 12:06:04 +0530 ICON has completed the acquisition of MediMedia Pharma Solutions. The acquisition brings ICON new scientific communications capabilities which together with ICON's existing Commercialisation and Outcomes practices, creates the industry's leading integrated market access solution. Commenting on the completion of the acquisition, Mr Ciaran Murray, CEO, ICON "Helping customers establish and communicate the value of their products has become increasingly important as payers look for evidence linking efficacy, value and price. MediMedia deepens the expertise and capabilities of our market-leading commercialisation and outcomes group and brings outstanding scientific and medical communications capabilities. We are delighted to welcome them to the ICON team."   ]]> https://biospectrumindia.com/news/97/4960/boston-scientific-to-acquire-endos-medical-device-business.html https://biospectrumindia.com/news/97/4960/boston-scientific-to-acquire-endos-medical-device-business.html Mon, 02 Mar 2015 12:19:38 +0530 According to reports, Boston Scientific is reportedly close to acquiring the AMS (American Medical Systems) medical device business of Endo Pharmaceuticals for around $2 billion Endo International acquired AMS for $2.9 billion in 2011. Three years after the acquisition it put up AMS for sale at a discount to its acquisition price in August 2014. Reportedly, Endo plans to divest its AMS unit so that it can focus on its core market-leading products, which primarily include pharmaceuticals. Pharmaceuticals comprises of over 80 percent of the total revenue generated by Endo.    ]]> https://biospectrumindia.com/news/97/6560/illumina-launches-the-neoprep-library-prep-system.html https://biospectrumindia.com/news/97/6560/illumina-launches-the-neoprep-library-prep-system.html Sun, 01 Mar 2015 09:31:00 +0530 Illumina has announced the launch of the NeoPrep Library Prep System, which simplifies library preparation and delivers high-quality sequencing-ready libraries for next-generation sequencing (NGS). The NeoPrep System performs library prep, quantification and normalisation, in a single, self-contained instrument. Innovative digital microfluidics technology decreases hands-on time from several hours to 30 minutes. By precisely manipulating droplets within the tightly controlled library card environment, the system delivers reliable, high-quality DNA and RNA libraries from starting amounts 4 to 10 times lower than those required for equivalent manual assays. "Illumina is enabling the broadest-possible adoption of NGS across research, clinical, and applied markets," said Mr Kirk Malloy, senior vice-president and general manager, Illumina's Life Science Business. He added, "The NeoPrep System is a key milestone in the evolution of NGS technology. It makes NGS accessible to any lab by radically simplifying the library preparation process, creating a seamless workflow of Illumina solutions for library preparation, sequencing, and data analysis. By continuing to drive adoption of NGS, we aim to help our customers generate new discoveries and applications in oncology, reproductive health, forensics, microbiology, and other key markets." The NeoPrep System is designed for use with the Illumina portfolio of library preparation kits, supporting the most commonly used NGS applications on all Illumina sequencing systems. Each kit includes the library card as well as all reagents required to create NeoPrep libraries.     ]]> https://biospectrumindia.com/news/97/6732/quintiles-among-fortune-500-list-of-most-admired-companies-in-2015.html https://biospectrumindia.com/news/97/6732/quintiles-among-fortune-500-list-of-most-admired-companies-in-2015.html Sun, 01 Mar 2015 09:23:00 +0530 Quintiles, the world's largest biopharmaceutical services company, has been named to FORTUNE magazine's "World's Most Admired Quintiles is ranked third overall in FORTUNE's Healthcare: Pharmacy and Other Services category with the top ranking for the reputation attribute of "global competitiveness" and second within the segment FORTUNE's World's Most Admired Companies list is the definitive report card on corporate reputations. Since 1997, Fortune has identified, selected and ranked the World's Most Admired Companies, uncovering the business practices that make these companies highly regarded among their peers. "I would like to congratulate Quintiles' employees around the world for making this possible," said Quintiles Chief Executive Officer Tom Pike. "Being named one of the World's Most Admired Companies "It is recognition that Quintiles is headed in the right direction to deliver value for customers as we improve their probability of success," Pike continued. "It is now up to all of us in the organization to live upto these expectations." Quintiles recently entered its 33rd year of operation, having been established at the University of North Carolina at Chapel Hill in 1982 by biostatistics professors Dr Dennis Gillings, CBE and Gary Koch, PhD. The company, which once operated out of a trailer on the UNC campus, now conducts business in approximately 100 countries.   More than three decades later, Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services as the company helped develop or commercialize all of 2013's top-100 best-selling drugs on the market (2014 statistics pending). During 2014, Quintiles was recognized as the "Best Contract Research Organization" (CRO) in the UK SCRIP awards, named "Asia CRO of the Year" by Frost and Sullivan, voted "Best CRO in Asia" in the BioPharma Asia Industry Awards and was named "Best Contract Sales Organization (CSO)" in the PharmaField awards as well as being named to the Fortune 500 for the first time. ]]> https://biospectrumindia.com/news/97/6046/who-launches-global-campaign-for-use-of-smart-syringes-.html https://biospectrumindia.com/news/97/6046/who-launches-global-campaign-for-use-of-smart-syringes-.html Thu, 26 Feb 2015 13:04:37 +0530 Director general of the World Health Organization (WHO), Ms Margaret Chan flagged off the "Global Campaign for Safe Injection Practice." It is the biggest worldwide safe health initiative on the use of a new injection safety policy and global campaign advocating the use of auto-disable (AD) syringes. Dangerous injection practices led to the accidental infection worldwide of 1.7 million people with hepatitis B, 315,000 with hepatitis C and as many as 33,800 with HIV in 2010, according to a 2014 WHO-sponsored study. WHO urged the countries to switch to the exclusive use of the Auto-Disable "smart" syringes, that can only be used once in order to better battle deadly diseases spread by needle sharing in an endeavor to eliminate millions of avoidable deaths and infections due to use of reusable syringes and unsafe injection practices. "It is a very proud moment for India that WHO has chosen India as the focus country to tackle the pervasive issue of unsafe injection practices and also because the global leader and innovator in AD syringes happens to be an Indian company, Hindustan Syringes and Medical Device Ltd (HMD) shall work hand in glove with WHO's global directive for use of Auto Disposable syringes in public healthcare systems," said Mr Rajiv Nath, forum coordinator AIMED and Joint MD, HMD. It may be noted that HMD happens to be the world's largest manufacturer of AD syringes and is also a coalition partner of SIGN (Safe Injection Global Network) and a strategic partner of GAVI - the global vaccine alliance for public-private health partnership committed to increasing access to immunization in developing countries. "Adoption of safety-engineered syringes is absolutely critical to protecting people worldwide from becoming infected with HIV, hepatitis and other diseases. This should be an urgent priority for all countries," said Dr Gottfried Hirnschall, director of the WHO HIV/AIDS Department.   "I do very sincerely hope that Government of India ,in light of the WHO initiative will now follow its own directives on the use of AD syringes in public healthcare system and in fact make it mandatory for use of AD in all public healthcare system," said Mr Nath.   ]]> https://biospectrumindia.com/news/97/5446/transasia-bio-medicals-launches-new-products.html https://biospectrumindia.com/news/97/5446/transasia-bio-medicals-launches-new-products.html Thu, 26 Feb 2015 10:13:00 +0530 The ERBA Group of Companies, a subsidiary of Transasia Bio-Medicals has launched its latest Hb Vario, EBG Stat 820 /1020 Blood gas analyzer, semi-automated hemostasis- ECL 412/ ECL 105 and fully automated urine sedimentation, Laura XL- Line. The Product was launched at the Arab Health Exhibition held between 26-29 January 2015 at the Dubai International Convention and Exhibition Centre. The ERBA Group was represented by Mr Suresh Vazirani, chairman and MD, and his team. ERBA has been an active part of the exhibition for eleven years. This year too, the ERBA Group showcased some of its latest and best technologies in the field of Hemostasis, Immunology and Diabetic management based assays, using HPLC based HbA1c analyzer as well as its critical product range of blood gas analyzers. The ERBA team has managed to grab some spot orders as well, from reputed organizations across the world, at the exhibition.   ]]> https://biospectrumindia.com/news/97/4971/sequel-wins-emerging-india-2014-award.html https://biospectrumindia.com/news/97/4971/sequel-wins-emerging-india-2014-award.html Wed, 25 Feb 2015 09:02:00 +0530 SEQUEL LOGISTICS was awarded the 'EMERGING INDIA 2014 AWARD'.  The award, a benchmark of excellence for Indian SMEs was presented by ICICI Bank and CNBC TV 18 and powered by CRISIL. It was a recognition of the mantra of innovation as the necessary core competence to remain competitive in the business. Given the continuing turbulent market conditions, this year at the ICICI Bank and CNBC TV18's Emerging India Awards, the focus was on the sustainability of businesses in these uncertain economic conditions.   ]]> https://biospectrumindia.com/news/97/5035/toshiba-appoints-new-directors.html https://biospectrumindia.com/news/97/5035/toshiba-appoints-new-directors.html Tue, 24 Feb 2015 14:22:45 +0530 Toshiba Medical Systems has announced that it has named Mr Guy Poloni as director, MR Business Unit, and Mr Bill Newsom as director, X-ray Vascular Business Unit. They will be responsible for implementing strategic marketing plans that drive growth and profitability for their respective product lines. They will also interface with the global business units at Toshiba Medical Systems Corporation to communicate the needs and requirements of the US market. "Mr Guy's proven track record and expertise in the MR market make him the perfect leader of the MR Business Unit," said Mr Calum Cunningham, vice president, Marketing and Strategic Business Development, Toshiba. Mr Poloni was Toshiba's 3T product manager from 2011 to 2014 and most recently served as deputy director of MR at Toshiba Medical Research Institute. Mr Newsom also comes from within Toshiba, having been with the company since 2003. He has held several senior roles in the X-ray Vascular Business Unit and in Sales, having served most recently as the West Zone Business Manager for X-ray Vascular.   "Mr Bill's extensive knowledge of the X-ray vascular market and our products, and his dedication to giving customers a voice, will help drive sales for our industry-leading products in this segment," said Mr Cunningham.   ]]> https://biospectrumindia.com/news/97/4952/government-to-offer-incentives-for-medtech-industry.html https://biospectrumindia.com/news/97/4952/government-to-offer-incentives-for-medtech-industry.html Tue, 24 Feb 2015 12:48:59 +0530 Reportedly, the government is expected to announce an incentive package, including tax benefits, in the forthcoming Budget for domestic manufacturers of medical devices. In its Budget proposals, the Commerce and Industry Ministry has suggested to increase import duty on medical devices product, including syringes and pacemaker. There is an issue of inverted duty structure on these products currently. This means customs duty on the final product is less than the duty on some raw materials essential for domestic manufacturing of syringes. It has also suggested that the countervailing duty on the imported raw material should be exempted on use basis for pacemakers.       ]]> https://biospectrumindia.com/news/97/4929/hindustan-syringes-who-to-promote-auto-disable-syringe.html https://biospectrumindia.com/news/97/4929/hindustan-syringes-who-to-promote-auto-disable-syringe.html Tue, 24 Feb 2015 11:47:55 +0530 Hindustan Syringes and Medical Device (HMD) will partner with the World Health Organization (WHO) in a campaign to prevent deaths and serious infections caused due to reusable syringes and unsafe injection practices, as per reports. 'Hindustan Syringes and Medical Devices shall partner with WHO and play a very crucial role in this third global health initiative to help prevent millions of deaths and serious infections,' the company said in a statement. 'This by-far is the biggest of WHO's global initiative since the remarkable success of polio eradication and hand-wash awareness campaigns,' it added. The campaign, to be launched shortly, aims to completely eliminate the practice of using re-usable syringes and replace it with auto-disable (AD) syringes. It will also focus on broad-basing the use of auto disposal syringes from immunization to therapeutic usage. 'Syringes should be a life giver, not life taker. It is a very fulfilling moment for my company and an emotional one at personal level as thousands of people unnecessarily lose life in our country due to unsafe injection practices,' said Mr Rajiv Nath, joint managing director, HMD.   ]]> https://biospectrumindia.com/news/97/4802/nurotron-receives-approval-for-sale-in-india.html https://biospectrumindia.com/news/97/4802/nurotron-receives-approval-for-sale-in-india.html Mon, 23 Feb 2015 13:20:18 +0530 The system is a safe, reliable and effective solution for children and adults suffering from severe and profound hearing loss. Headquartered in New Delhi, CDSCO is India's main regulatory body for pharmaceuticals and medical devices. CDSCO organization safeguards and enhances the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. "This approval by India's primary drug and medical device oversight organization is a major achievement for Nurotron's cochlear implant system," says Mr Chu Li, CEO, Nurotron. "The validation of the efficacy of Nurortron's offerings in the important Indian market confirms the company's position as a global leader in cochlear implant technology." Nurotron already holds the CE mark in Europe for the Venus Cochlear Implant System, and has received approval to sell in China and Turkey as well. ]]> https://biospectrumindia.com/features/97/4792/corporate-players-focusing-more-on-small-towns-and-rural-areas.html https://biospectrumindia.com/features/97/4792/corporate-players-focusing-more-on-small-towns-and-rural-areas.html Mon, 23 Feb 2015 13:07:16 +0530 The total market size for the medical imaging reagents in India is pegged at US $250-300 million. In the global arena, India acts as an attractive destination for biopharmaceutical companies across the world, serving as a magnetic place for executing strategic R&D functions. In such a situation, more and more lab in the country is facing the need for better understanding in molecular pathology and accurate tools for cell analysis. Mr Ravi Shastri, MD, South Asia, Life Science Solutions, Thermo Fisher Scientific, says that enhanced accuracy of cell imaging and analysis systems helps in reducing the time and costs involved in the drug discovery process. "This is a major factor driving the growth of the cell analysis market. Furthermore, the market is witnessing significant technological innovations and continuous improvements in cell analysis instruments and consumables for applications such as cell identification, cell proliferation, and target toxicity studies," he commented.   Market growth accelerators A number of factors, including rising R&D activities by big pharma and biotech companies, increased government funding for development of pharmaceutical industry, and growing number of CROs in markets such as India are stimulating the growth of the preclinical imaging market in the Asia-Pacific region. According to a report by Market and Research, the APAC is expected to foresee the highest growth due to strong economic developments, high incidence rate of cardiovascular diseases coupled with increasing demand for non-ionizing imaging reagents. "The growth can also be attributed to a number of factors such as the rising cases of cancer. Furthermore, government bodies have extended their help in the form of investments, grants, and funds for cell-based research activities. Government funding and funneling investments to faster and accurate diagnosis to combat infectious disease and advance researches in cancer are also boosting the growth," pointed out Mr Shastri. Another report published by Transparency Market Research states that medical imaging reagents' application in the drug discovery and development is expected to act as a growth propeller for the imaging reagents business.   Rural and small towns A major key trend in the industry is the establishment of healthcare imaging and diagnostic centers by corporate players with more focus on small towns and rural areas. "The market for imaging is mainly driven by consumables and reagents. The intense competition adds pressure on laboratories and healthcare settings to differentiate from the others by using better reagents and high-tech devices," added Mr Faisal Ghaus, VP, TechNavio, a global technology research and advisory company. Emerging markets In the APAC region, India, China, Malaysia, Indonesia, and Philippines are seen as emerging markets for medical imaging reagents.   Growth in the Asian market is largely spurred by government support for the development of innovative screening technologies and rising demand for outsourcing of drug discovery services. "Increasing diagnostics and imaging procedures, medical tourism activity in these regions and competition forcing the healthcare services to upgrade their existing medical imaging systems or to build new centers is increasing the demand for more medical imaging systems and reagents market in the region," revealed Mr Ghaus. In the West, North America and Europe are considered to be the largest markets. PPP strategy Analysts observe that companies are entering into public-private partnerships (PPP) with various state governments to increase the number of imaging and diagnostic centers and to upgrade the existing facilities.   For example, GE healthcare signed MoU with government of Gujarat and Maharashtra to upgrade medical technology and set-up diagnostic imaging centers in medical colleges and hospitals under the PPP model. India's price sensitivity Major global players are trying to strengthen their opportunity in India using its strong position in CROs (contract research organizations), large pool of skilled medical and paramedical professionals, and cost advantage. Again, for example, GE healthcare manufactured high-end CT in India for the first time, making it the first global player to manufacture in India. Mr Ghaus believes that the main strategy behind this is to reduce costs associated with imports, and tap the price-sensitive market in India.   Due to the price-sensitive nature of Indian market, many healthcare settings use low-cost reagents supplied by local players. This could deter the market growth to its potential. Key growth drivers: - Rise in incidences of cardiovascular, oncological, and neurological disorders- Increasing adoption of diagnostic and imaging devices- Increasing healthcare accessibility and facilities Key challenges:- Lack of reimbursements for imaging procedures- Cost-sensitive market- Disparity of healthcare imaging and diagnostic services in rural and urban areas Key players in India & APAC:Bayer Healthcare AGBioHouse SolutionsBracco Imaging SpACentral Drug House GE HealthcareLoba ChemieSiemens HealthcareThermo Fisher Scientific Global medical imaging reagents market segments (Courtesy: Transparency Market Research)   By Class Contrast reagentsOptical reagentsNuclear reagents By Technology NanoparticlesFluorescent proteinsFluorescent dyes and probesRadiopharmaceuticalsQuantum dots By Applications DiagnosticsDrug discovery and developmentR&D   ]]> https://biospectrumindia.com/news/97/5869/global-bioinformatics-market-will-be-12-billion-by-2020.html https://biospectrumindia.com/news/97/5869/global-bioinformatics-market-will-be-12-billion-by-2020.html Sun, 22 Feb 2015 09:45:00 +0530 The global bioinformatics market will grow from $4.11 billion in 2014 to $12.54 billion by the end of 2020, says a new report from Persistence Market Research. According to the report, The market is growing at a compounded Annual Growth Rate (CAGR) of 20.4 percent from 2014 to 2020. This growth will be driven by a range of different factors, including rising research and development expenditure, increasing development of personalised medicines and clinical diagnostics, the growing need for integrated bioinformatics systems in genomics and proteomics, and increasing applications of bioinformatics in drug discovery and development. Increasing number of merger and acquisition and new product innovation are some of the latest trend in bioinformatics market. Nanopore sequencing technology is one of the growth opportunities for the bioinformatics market. North America is dominating the global bioinformatics market due to its advanced IT infrastructure and a rising number of R&D centers. However, Asia is the fastest growing market for bioinformatics due to rising number of R&D activities and rising government fund for research and developments.     ]]> https://biospectrumindia.com/news/97/4326/twitter-a-new-tool-for-health-research.html https://biospectrumindia.com/news/97/4326/twitter-a-new-tool-for-health-research.html Sun, 22 Feb 2015 09:19:00 +0530 A new study by the University of British Columbia finds that using Twitter can help physicians be better prepared to answer questions from their patients. It also states that more and more health care professionals are embracing social media. The researchers spent six months monitoring conversations surrounding stem cell research related to spinal cord injury and Parkinson's disease on Twitter. They found roughly 25 percent of the tweets about spinal cord injury and 15 percent of the tweets about Parkinson's disease were from health care professionals. The study also found that the majority of tweets were about research findings, particularly the ones perceived as medical breakthroughs. The most shared content were links to research reports. It also discovered that the users tweeting about spinal cord injury and Parkinson's disease differed. Users who tweeted about spinal cord injury talked about clinical trials, while users who tweeted about Parkinson's disease mostly talked about new tools or methods being developed to conduct research.Less than five percent of the tweets spoke out against stem cell research, which surprised the researchers. "We expected to see debate on stem cell controversy. But people are sharing ideas of hope and expectations much more than anything else," said Ms Julie Robillard, lead author and neurology professor at UBC's National Core for Neuroethics and Djavad Mowafaghian Centre for Brain Health.   The study was presented at the 2015 Annual Meeting of the American Association for the Advancement of Science (AAAS).     ]]> https://biospectrumindia.com/news/97/3867/indian-medical-device-industry-can-be-a-potent-force-globally.html https://biospectrumindia.com/news/97/3867/indian-medical-device-industry-can-be-a-potent-force-globally.html Sat, 21 Feb 2015 09:51:00 +0530 India's medical device industry has a huge untapped potential and can be a major force globally, if proper regulatory frame work and support is provided, according to a report by the National Health Systems Resource Centre (NHSRC). The report was released at the National Symposium of Safety of Medical Devices, organised in association with UL (Underwriters Laboratories). It reinforces the need for bringing in a systematic and harmonised approach towards testing for safety and efficacy of medical devices. The national symposium witnessed the launch of two reports on setting up medical device testing laboratories for electrical and electronic medical devices as well as for biomaterials and medical implants. The reports was developed by the National Health Systems Resource Centre, in technical collaboration with the WHO Country Office for India and with technical inputs from UL in India and Sree Chitra Tirunal Institute of Medical Sciences and Technology. It highlight the basic requirements, work flow, infrastructure and human resources required for establishing medical devices testing laboratories. "The government approving 100 percent foreign direct investment (FDI) in the medical devices sector is a positive step towards developing the overall healthcare infrastructure, thereby reducing our dependency on imports. The expected inflow of investment should target research, testing and infrastructure strengthening to promote domestic manufacturing," said Mr Suresh Sugavanam, vice president and managing director, UL South Asia. He added, "UL has made significant investments in terms of resources and laboratories to support the industry. The current landscape is highly fragmented and calls for a restructuring of regulatory framework to boost the industry."  "Access to safe, good quality and effective medical devices is an important component of health services. With the increasing commitment of the government towards achieving health for the people, proportionate effort is required towards developing systems such as testing laboratories to support the medical devices sector. Only with comprehensive and collaborative effort can the nation progress towards self-dependency and bring cost-effective and safe medical technologies within the reach of masses," said Dr Sanjiv Kumar, executive director, NHSRC.     ]]> https://biospectrumindia.com/news/97/3458/philips-completes-acquisition-of-volcano.html https://biospectrumindia.com/news/97/3458/philips-completes-acquisition-of-volcano.html Fri, 20 Feb 2015 12:58:19 +0530 Royal Philips has announced that it has completed the acquisition of Volcano Corporation. Volcano's financial results will be consolidated as part of Philips' image-guided therapy business group as of February 17, 2015. Philips' long-standing partnership with Volcano, the retention of key management members and in-depth preparations will facilitate the integration into Philips' image-guided therapy business group. "The completion of the Volcano acquisition is an important milestone in our strategy to become the leading systems integrator in the fast growing image-guided minimally invasive surgery market and accelerate our growth in that market," said Mr Frans van Houten, chief executive officer, Royal Philips. He added, "The combination of Volcano's broad portfolio of imaging and measurement catheters and Philips' leading interventional imaging solutions allow us to provide our customers with an integrated solution to improve procedural outcomes at a decisive stage in the health continuum." As a result of the merger, all remaining Volcano shares were converted into the right to receive $18.00 per share in cash, without interest, less any applicable withholding of taxes, the same price that was paid in the tender offer.   ]]> https://biospectrumindia.com/news/97/7534/bd-introduces-facs-presto-in-india.html https://biospectrumindia.com/news/97/7534/bd-introduces-facs-presto-in-india.html Fri, 20 Feb 2015 09:34:00 +0530 BD ( Becton Dickinson and Company ) has launched a new efficient CD4 count monitoring system, FACS Presto on February, 17, 2015. The platform is a near patient system that can measure the absolute and percentage of CD4 T Lymphocytes and haemoglobin concentration from whole body blood.  Weighing less than 7 kgs, the system is capable of testing samples from venous or capillary blood for more than 6 hours continously due  tobuilt in rechargeable battery. This is a unique feature as it can easily work in remote settings.  The National AIDS Research Institute (NARI), Pune had conducted a evaluative study on the 150 samples. It found out that the accuracy is perfect. As per its spokesperson,  FACS Presto has shown great accuracy and precision during the tests and it equals to the current gold standard.   The CD4 testing of HIV AIDS patients allows the patients an access to treatment and monitoring,  thereby reducing the risk of transmission of disease to others and plan a proper treatment schedule. As per Mr Varun Khanna, managing director, BD India, FACS Presto expands the the ability to stage and manage the HIV AIDS patients near their homes. With this launch, we are hopeful that the system will be helpful in limited resource settings such as states of Andhra Pradesh, Maharashtra,  Karnataka and North Eastern region " ]]> https://biospectrumindia.com/news/97/3294/cipla-invests-in-a-respiratory-device-firm.html https://biospectrumindia.com/news/97/3294/cipla-invests-in-a-respiratory-device-firm.html Thu, 19 Feb 2015 13:13:57 +0530 Cipla has announced that it will acquire 60 percent stake in Jay Precision Pharmaceuticals for Rs 96 crore, says reports. Jay Precision is an existing supplier of respiratory devices to the company and has a manufacturing facility at Vasai, Maharashtra. "Considering company's leading position in inhalation therapy, this transaction is aimed at integrating the value chain and will serve as a platform for the development of next generation respiratory devices," the company said in a statement. The transaction is expected to be completed by the end of this financial year, subject to completion of certain conditions.   ]]> https://biospectrumindia.com/news/97/3986/boston-scientific-settles-dispute-with-jj.html https://biospectrumindia.com/news/97/3986/boston-scientific-settles-dispute-with-jj.html Thu, 19 Feb 2015 13:13:14 +0530 Boston Scientific Corporation has announced the settlement of the breach of merger agreement lawsuit brought by Johnson & Johnson (J&J) against Guidant Corporation. The issue stemmed from Boston Scientific's acquisition of Guidant. In the lawsuit filed in 2006, J&J alleged that Guidant breached the merger agreement it had with Johnson & Johnson, and sought more than $7 billion in damages. Guidant disputed the allegations. As a result of the settlement agreement, Johnson & Johnson has agreed to permanently dismiss its action without acknowledgment of liability by Guidant. Additionally, Boston Scientific will make aggregate payments totaling $600 million to J&J. The company expects to record a pre-tax litigation-related charge of approximately $600 million within its fourth quarter 2014 results as a recognized subsequent event. This charge will be excluded from Boston Scientific's non-GAAP measures of adjusted income that were previously announced. In connection with the settlement, it has also agreed not to bring patent infringement or other claims related to Johnson & Johnson's SMART, SMART Control, and SMART Flex stent products. "We feel this settlement is in the best interests of the company and its shareholders. We are pleased to end this longstanding litigation between Guidant and Johnson & Johnson, and to continue focusing on delivering innovative products and solutions to physicians and patients," said Mr Tim Pratt, executive vice-president, chief administrative officer, general counsel and secretary, Boston Scientific.   ]]> https://biospectrumindia.com/news/97/6555/medgenome-natera-to-bring-nipt-to-india.html https://biospectrumindia.com/news/97/6555/medgenome-natera-to-bring-nipt-to-india.html Wed, 18 Feb 2015 12:33:09 +0530 As part of the agreement, MedGenome will have exclusive license to develop the capacity and perform the Panorama test in India. Natera's test, known as Panorama, examines fetal DNA in the mother's blood to assess whether a developing baby is at high risk for having an abnormality in the chromosomes. Panorama uses a simple blood draw from the mother to screen for trisomy 21 (Down's syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and select sex chromosome abnormalities, such as monosomy X (Turner syndrome). Panorama is the only screening test in the world that detects triploidy status in the fetus (69 chromosomes rather than 46 chromosomes), and reports whether a 'vanishing' twin was present, i.e. there was a twin but it got absorbed, and is no longer detectable by ultrasound. Panorama can be performed from as early as 9 weeks gestation. In contrast to traditional prenatal genetic testing like chorionic villus sampling and amniocentesis, which are invasive tests, Panorama does not pose any risk for the fetus.   ]]> https://biospectrumindia.com/news/97/6695/transasia-launches-a-new-blood-analyzer.html https://biospectrumindia.com/news/97/6695/transasia-launches-a-new-blood-analyzer.html Wed, 18 Feb 2015 12:27:00 +0530 Transasia, a leading invitro diagnostc company has added a new product to its diagnostic line with the launch of its ERBA EBG Stat- Fully Automated Critical Care Analyzer. Aimed at clinicians working with large samples of Blood gas/electrolyte/metabolites analysis, the ERBA EBG offers quick results with an accurate analysis.  EBG Stat is based on the Micro Sensor Cartridge (MSC) Technology. The miniaturized sensor card replaces all periodic procedures for electrode / membrane replacements and is maintenance free.   ]]> https://biospectrumindia.com/news/97/4425/theorem-clinical-research-join-hands-with-biomedical-systems.html https://biospectrumindia.com/news/97/4425/theorem-clinical-research-join-hands-with-biomedical-systems.html Wed, 18 Feb 2015 12:19:23 +0530 Theorem Clinical Research and Biomedical Systems have formed a strategic partnership to expand the suite of services available to clients worldwide. "Theorem's business strategy is to offer our clients the very best available services in every research area," said Mr John Potthoff, president and CEO, Theorem . He added, "Biomedical Systems is one of the true pioneers in our industry, supervising breakthrough research innovations in centralized cardiac safety, pulmonary function, imaging, scientific affairs and electronic clinical outcome assessment (eCOA). The company's broad range of capabilities and global scale are a complement to Theorem studies being conducted around the world." Mr Tim Barrett, CEO, Biomedical Systems said, "The right strategic alliance strengthens both companies, empowering us both to offer enhanced services to our clients. We believe this alliance with Theorem creates a synergy that will be a benefit to all."   ]]> https://biospectrumindia.com/news/97/5523/india-life-sciences-fund-ii-invests-in-medtech-cos.html https://biospectrumindia.com/news/97/5523/india-life-sciences-fund-ii-invests-in-medtech-cos.html Tue, 17 Feb 2015 12:40:00 +0530 Reportedly, India Life Sciences Fund II has invested Rs 92 crore (approx $15 million) in Comprehensive Prosthetics and Orthotics (CPO) and Relisys Medical Devices. New Delhi-based Comprehensive Prosthetics and Orthotics (CPO) makes artificial limbs, while Hyderabad-based Relisys Medical Devices is involved in development, manufacturing and commercialization of medical devices to treat life-threatening diseases including cardiovascular, peripheral vascular, neurovascular (stroke), and structural heart disease. The fund has invested Rs 60 crore in CPO and the rest Rs 32 crore in Relisys. It has raised Rs 865 crore last year to invest in mid-market companies in healthcare services, pharmaceuticals and medical technology.   ]]> https://biospectrumindia.com/news/97/5532/maverix-biomics-elsevier-sign-ngs-data-interpretation-agreement.html https://biospectrumindia.com/news/97/5532/maverix-biomics-elsevier-sign-ngs-data-interpretation-agreement.html Tue, 17 Feb 2015 12:29:45 +0530 Maverix Biomics has announced a strategic cooperation agreement with Elsevier. The agreement is to streamline the interpretation of raw next-generation sequencing (NGS) data to reveal new insights and to assist with critical decision making. The Maverix Analytic Platform will complement Pathway Studio's sample-to-insight workflow and incorporation of biological data from Elsevier's biology journals. The combination of the Maverix Analytic Platform and Elsevier's Pathway Studio is an integrated solution. It starts with raw NGS data and quickly produces genome alignment, quality metrics, variant and expression analysis, and the ability to analyse and visualise disease mechanisms derived from published scientific data. "This collaboration gives more value to our customers, not only can they use the two great tools our companies produce, but they can now save time by seamlessly using them together. This reduces their workload, reduces complexity and increases accuracy of their analysis," said Ms Jaqui Hodgkinson, VP product development of Elsevier Life Sciences Solutions. "We are pleased to be able to offer the Maverix Analytic Platform directly integrated with the Elsevier's Pathway Studio solution for researchers," said Mr Dave Mandelkern, Maverix president and co-founder. He added, "The combined offering will help researchers unravel hidden biology in experimental data or literature-based evidence, which will be especially useful in building and visualizing disease models." Financial details of the deal were not disclosed.   ]]> https://biospectrumindia.com/news/97/5555/roche-acquires-another-genomics-company.html https://biospectrumindia.com/news/97/5555/roche-acquires-another-genomics-company.html Tue, 17 Feb 2015 12:21:27 +0530 Roche has announced the acquisition of Germany-based Signature Diagnostics. Signature is a translational oncology and genomics company that develops large blood plasma and tissue biobanks in multiple cancers. It uses the samples from its biobanks along with accompanying clinical progression and genetic data to develop and validate circulating cell free DNA (cfDNA) tests1 which have the potential to advance non-invasive treatment response monitoring for patients with cancer. "Biobanks play an important role in uncovering the cause or origin of disease such as cancer which is important in translational research and the development of personalized therapies for patients," said Mr Roland Diggelmann,COO, Roche Diagnostics. He added, "Signature represents a unique bridge between high value cancer biobanks and NGS assay development. Roche plans to leverage Signature's expertise in both of these areas to accelerate the development of targeted NGS-based diagnostics in the future. Biobanks can also be used for biomarker discovery and hypothesis testing with Pharma." "We are very pleased Roche recognizes the importance of high-quality longitudinal cancer biobanks for the development of novel NGS-based diagnostics. Joining forces with Roche is very exciting as it will allow us to further develop our NGS assays for sequencing tests using cfDNA which may advance the development of non-invasive treatment response monitoring for cancer patients," said Dr Andre Rosenthal, CEO, Signature. Signature will be integrated into Roche Sequencing Unit and will continue to focus on expanding its innovative genomic signature portfolio. This is the third genomics company that Roche has acquired recently, the other two being Bina Technologies and Genia Technologies.     ]]> https://biospectrumindia.com/news/97/3920/global-home-healthcare-market-will-be-303-6-billion-by-2020-.html https://biospectrumindia.com/news/97/3920/global-home-healthcare-market-will-be-303-6-billion-by-2020-.html Tue, 17 Feb 2015 09:21:00 +0530 A new report by Transparency Market Research, finds that the global home healthcare market will increase to $303.6 billion in 2020 from $176.1 billion in 2013. The market is broadly divided into devices and services. Home healthcare devices market can be further subdivided into diagnostics and monitoring devices, therapeutics devices and medical supplies. The market for diagnostics and monitoring devices segment account for the largest share of the home healthcare devices market. The fastest growing segment is therapeutics devices, which is expected to grow at a compound annual growth rate (CAGR) of more than 10 percent from 2014 to 2020. It comprises of insulin delivery devices, nebulizers, ventilators and dialysis equipment etc. The services segment is the largest within the overall global home healthcare market, providing services like rehabilitation, telehealth and telemedicine, respiratory therapy. Some of the bigger players in the home healthcare market are, Bayer AG, Abbott Laboratories, GE Healthcare, Johnson & Johnson among others.   ]]> https://biospectrumindia.com/news/97/6503/medical-device-makers-and-their-budget-wishlist.html https://biospectrumindia.com/news/97/6503/medical-device-makers-and-their-budget-wishlist.html Mon, 16 Feb 2015 13:00:03 +0530 Reportedly, the Association of Indian Medical Device Industry (AIMED) has sought import duty concessions in the upcoming Budget. It has also demanded a blanket ban on 100 percent foreign direct investment (FDI) in brown field projects. Further, the industry body has also sought re-imposition of special additional duty (SAD) of 4 percent on import of medical devices. "To enable the nascent Indian medical devices industry to survive. India needs to consider rationalization of import duties to be zero percent for natural resource, 2.5-5 percent for basic raw materials and packaging materials, 5-7.5 percent for components and consumables," AIMED said in a statement. "And at least 10 percent for finished medical devices or consumer goods to encourage manufacturing of components and complete devices," it added. "Export subsidy should be given where fiscal incentives are robust enough to match our competitors. China gives 17 percent export subsidy thereby ensuring a healthy minimum margin of 10 percent exporters. We have no such matching policy," it further added.   ]]> https://biospectrumindia.com/news/97/5769/biotime-partners-with-advaita.html https://biospectrumindia.com/news/97/5769/biotime-partners-with-advaita.html Mon, 16 Feb 2015 12:58:26 +0530 LifeMap Sciences, a subsidiary of BioTime has announced a partnership agreement with Advaita Corporation, which develops and sells iPathwayGuide, an advanced web-based pathway analysis platform capable of identifying mechanisms of action and potential drug targets directly from gene-expression experiments. Under the agreement, iPathwayGuide will be integrated into LifeMap's GeneCards database of human genes, and offered to GeneCards' large user base of life scientists. "We are excited to introduce iPathwayGuide to our user base and believe that it fits well with our GeneCards Plus tools and our extensive knowledgebase related to genes, pathways, cells and diseases," said Mr Yaron Guan-Golan, chief marketing officer, LifeMap Sciences. By offering iPathwayGuide, LifeMap is expanding its offering of research tools to provide an advanced and unique tool that is easy to use, easy to interpret, and fits all budgets. In addition to its advanced pathway and gene ontology (GO) analysis, iPathwayGuide also offers the ability to identify putative mechanisms that can explain all observed expression changes, as well as identify the miRNAs that can play an important role in the condition under study. GeneCards Plus includes GeneAnalytics (http://geneanalytics.genecards.org/) a novel gene set analysis tool, GeneALaCart (http://genealacart.genecards.org), the GeneCards batch querying application and VarElect (http://varelect.genecards.org), the Next Generation Sequencing phenotyper. LifeMap holds the exclusive worldwide license to market GeneCards, MalaCards, GeneAlaCart and VarElect from Yeda Research and Development Company, the commercial arm of the Weizmann Institute of Science. "We are thrilled by the opportunity to partner with LifeMap Sciences, the provider of GeneCards, one of the most comprehensive databases of gene information. We think that our iPathwayGuide is a strong addition at the end of any analysis pipeline and a natural fit in the LifeMap suite of tools," said Dr Sorin Draghici, president and CEO of Advaita.   ]]> https://biospectrumindia.com/news/97/5662/wqia-launches-first-microbiological-standard-for-water-treatment-devices.html https://biospectrumindia.com/news/97/5662/wqia-launches-first-microbiological-standard-for-water-treatment-devices.html Mon, 16 Feb 2015 12:21:37 +0530 These standards have been specifically developed for Indian conditions and match global norms. Statistics compiled by the United Nations (UN) show that over one lakh people die of water-borne diseases annually in India. It is reported that groundwater in one-third of India's 600 districts is not fit for drinking as the concentration of fluoride, iron, salinity and arsenic exceeds the tolerance levels. About 65 million people have been suffering from fluorosis, a crippling disease due to high amount of fluoride and five million are suffering from arsenicosis in West Bengal alone, due to high amount of arsenic. The World Bank estimates 21% of communicable diseases in India are water related.   Of these diseases, diarrhea kills more than a 1000 people in India every day. The highest mortality from diarrhea is in children under the age of five, highlighting an urgent need for focused interventions. WQIA also released a quality seal that will help consumers choose water treatment devices that meet these standards. This development marks an important step towards ensuring genuine standards for water quality in a country where water-borne diseases are a major health hazard. Water Treatment Devices meeting WQIA standards are required to demonstrate effectiveness to eliminate all three types of disease causing organisms of concern (bacteria, virus & parasites), over an extended period of its life. Certified devices are also required to alert the user when repair or replacement is due and if any residue in treated water from the device is safe. Commenting on this landmark development, the president of WQIA Mr Marzin R Shroff, said, "The available purifying technologies are designed to solve a few of the many different water quality problems. If the input water contains material outside the designated specific contaminants addressed by the device it may not be removed. Not all the contaminants may be a priority. Therefore it was important to have standards that address Indian water conditions and we are glad that the industry has come together to support and adopt these standards - ultimately benefitting the customer." More than 10 Indian Water Purifier manufacturers have pledged to adopt these standards which were released at the 2nd WQA India Meeting. These include leading brands like Eureka Forbes, Kent RO, Alfa UV, Filtrex, AO Smith, Ion Exchange, Luminous, Tata Swachh among others. Together these WQIA members represent more than 70% of water purifier sales in India. The WQIA members also stressed on the need to ensure that all water purifiers sold in India meet these norms. The members urged the government to take adequate steps to ensure that purified drinking water norms are mandated to ensure reliable sources of drinking water for consumers. ]]> https://biospectrumindia.com/news/97/4391/india-to-get-medical-device-testing-labs.html https://biospectrumindia.com/news/97/4391/india-to-get-medical-device-testing-labs.html Mon, 16 Feb 2015 12:20:00 +0530 In a bid to boost the domestic medical device manufacturing sector, the commerce ministry has decided to fund the setting up of three medical device testing laboratories in Noida (UP), Haryana and Gujarat, say reports. These places already have device manufacturing clusters. Reportedly, Haryana and Gujarat governments have promised to allot land for the labs. However, in Noida, HLL Lifecare, a PSU, will be providing its campus for setting up the laboratory. "To grow the industry and achieve the $25 billion target, we need to lay greater emphasis on developing standards and making regulatory amendments to the existing Drugs and Cosmetics Act," said Mr Rajiv Capoor, joint secretary in the ministry in a statement. "The detailed report on setting up of these laboratories would be timely," he added.    ]]> https://biospectrumindia.com/features/97/6707/can-indian-companies-be-on-pfizers-next-ma-spree.html https://biospectrumindia.com/features/97/6707/can-indian-companies-be-on-pfizers-next-ma-spree.html Fri, 06 Feb 2015 18:12:26 +0530 Pfizer has approximately $15 billion of sales at risk from generic/biosimilar competition over the next 5 years, with the biggest losses expected to be suffered by its drugs including Lyrica, Zyvox, Viagra and Vfend. Despite the recent approval of Ibrance (palbociclib), Pfizer's late-stage pipeline is relatively weak, and the move to acquire Hospira will help insulate its top-line from the impact of patent expirations. Ever since its failed acquisition talks worth $118 billion with British-drug major AstraZeneca (AZ) in 2014, industry analysts speculated a wide range of possibilities for the pharma giant's next acquisition this New Year. The new announcement from Pfizer has arrived just in time. Pfizer was fairly subdued since the AstraZeneca deal collapse last year. "Whether this is indicative of the fact it is biding its time to repeat the attempt to secure AstraZeneca's assets, or rethink its corporate strategy, remains to be seen. The financial benefits of an AstraZeneca deal have been impacted by changes to the US tax laws regarding repatriation of overseas earnings, and the company might therefore look closer to home as far as external investment opportunity goes," predicted analyst Mr Joshua Owide in January 2015, who is GlobalData's director of healthcare industry dynamics. Hospira is an established biosimilars developer, most notably in Europe, where it already markets three biosimilars - Retacrit (erythropoietin zeta), Nivestim (filgrastim), and Inflectra (infliximab), which was the first biosimilar monoclonal antibody (mAb) to be approved in Europe.   Hospira also has a number of biosimilars in its late-stage pipeline, including trastuzumab (Herceptin), currently in Phase III, which is being evaluated for metastatic breast cancer. "This complements Pfizer's own foray into biosimilars, with development ongoing for copies of Herceptin, Rituxan and Remicade," added Mr Owide. Biologics vs Biosimilars Although biosimilars have been available in Europe and elsewhere for several years, the US Food and Drug Administration (FDA) only recently set out the pathway for the approval of biosimilars, coinciding with both the ramping up of biosimilar development programs and the wave of expirations impacting a number of major established biologic therapeutics. Mr Owide thus commented, "Pfizer will hope that by adding Hospira's expertise in the field of biosimilars, it will be better positioned to take market share in the lucrative biologics space."   While many big pharma companies pursue a path of smaller-scale biotech acquisitions, Pfizer appears intent on retaining its large-scale M&A model. Pfizer, in 2009, shelled out a whopping $68 billion to buy Wyeth, which had a portfolio of biotech drugs. Analysts conclude that Pfizer will continue to accrue significant value from its acquired assets through cost stripping exercises following consolidation. "However Pfizer's dependency on inorganic growth has become hugely repetitive and highlights the company's need to more actively invest in external assets earlier on in the product lifecycle and drive greater in-house R&D productivity," said Mr Owide. Again, biologics will be a key focal point, similar to the Wyeth deal a few years ago, while companies with strong development pipelines will be of particular interest, given Pfizer's own shortcomings in terms of new product developments.   The exponential growth of the biologic segment over the past decade or so has placed a significant burden on the US healthcare economy, given the high price of biologic medicines compared with more conventional small molecule therapies. While biosimilars are not expected to launch with the same level of price discounting as generic small molecules, the continued move towards cost containment will ensure that there is room for biosimilars in the US. Furthermore, biosimilars will possess significant revenue-generating capacity for the companies that market them. Mr Owide comments that Pfizer has struggled to match its size through R&D and is therefore particularly reliant on external innovation to maintain its position as a global pharmaceutical leader. "Despite Pfizer's historical presence in primary care diseases, the company is shifting increasingly towards specialty diseases, and this will also play a major role in determining its future acquisition targets," explained Mr Owide. India or China?   What about developing markets like India or China? Will Pfizer cast its shadow on these markets this year? Analysts say that there is always potential for companies to invest in emerging markets, notably in India, where the generics market is thriving. "Pfizer's commitment to innovative medicines will likely mean its focal point remains in the developed markets with regard to headline M&A deals," remarked Mr Owide. A number of Pfizer's peers are actively developing biosimilars, and they will be conscious of the benefits that Pfizer's biosimilar proposition will derive from the deal, with Hospira not only active in biosimilars, but also very active in oncology specialty injectables. This will improve Pfizer's access to the necessary prescribing channels when its oncology biosimilars, namely Herceptin and Rituxan, gain approval. AZ deal resurrected?   Another question that has been plaguing many minds in the industry is, will Pfizer make a comeback this year on its failed bid with AstraZeneca? Analysts think it could be feasible. However, the new US tax laws could be a major deterrent, as financial engineering was one of the major drivers behind Pfizer's record bid for AstraZeneca. Also, is it possible for Pfizer's M&A strategy to backfire at some point? There is an element of repeating the same action and expecting different results. Mr Owide opined, "Pfizer's approach has persistently failed to foster innovation and expand its intellectual property libraries in a truly meaningful way, meaning there are doubts as to how sustainable this approach can be." However, Pfizer will always look to deals with significant synergies, and those will largely be around manufacturing and commercial infrastructure, which is unlikely to change. The knock-on effect of Pfizer's deal-making more directly relates to its acquisition targets and their employees, rather than its own workforce. The AstraZeneca deal was slightly unique compared to its previous acquisitions, in that a large proportion of value was related to pipeline assets.   So rather than simply strip out costs, it would have had to foster innovation in order to accrue the underlining value from the deal. Pfizer's Split? Earlier, Pfizer's senior management had mentioned plans about the company splitting into two. "A separation would undermine Pfizer's mantra of being the world's number one drug company, but could make sense from strategic, financial and operational standpoints," Mr Owide stated. Generally speaking, financial engineering has been a fundamental driver behind the upsurge in M&A deals, with companies able to offer significant premiums on the basis of accruing higher future earnings through lower tax rates. The upsurge in approvals has also been an encouraging force, with companies looking to secure novel compounds at the earliest possible opportunity.   Pfizer's move away from primary care towards specialty care will be helped immensely by the integration of Hospira's specialty injectables business. The company is unlikely to discontinue any of the product lines it has acquired, and it will rather focus on turning them around to make it profitable. Innovation lost? Experts believe that M&As can work in two ways. Acquired companies with a history of innovation are increasingly operated as wholly-owned subsidiaries, rather than simply asset-stripped. "This is more fruitful in terms of sustained levels of innovation, as these companies and their employees are typically specialized in their fields," notes Mr Owide. Perfect examples of this model include Genentech (Roche), Genzyme (Sanofi) and Millennium (Takeda).   However, M&As that is largely focused on asset-stripping and operational synergies are much more damaging in terms of innovation. The value of these deals, while high, is largely tied to those assets already on the market or in late-stage development. As with any acquisition on this scale, Pfizer will identify overlapping functions where significant cost savings can be realized and axe employees as per its requirements. ]]> https://biospectrumindia.com/news/97/4417/advanced-bionics-receives-ce-mark-approval-for-cochlear-implants.html https://biospectrumindia.com/news/97/4417/advanced-bionics-receives-ce-mark-approval-for-cochlear-implants.html Thu, 05 Feb 2015 11:48:54 +0530 Advanced Bionics (AB) has announced that the HiRes 90K and HiRes 90K advantage cochlear implants have received CE Mark approval from the European Notified Body, TÃœV, to undergo 1.5T MRI scans without removing the internal magnet. Previously, these devices had regulatory approval to undergo MRI scans only if the magnet was removed. This additional compatibility for MRI scans while the CI magnet remains in place helps simplify the diagnostic process by avoiding additional pre- and post-MRI procedures to remove and then to replace the magnet. "Advanced Bionics prioritises the safety and well-being of patients with our cochlear implants. We are very pleased to offer patients this additional compatibility with MRI diagnostic equipment," said Mr Hansjuerg Emch, group vice-president Medical of the Sonova Group. Cochlear implants are implanted just beneath the skin, and use magnets to link the internal and external components of the CI system. The internal component of the AB cochlear implant system includes electronics and an electrode array that deliver AB's proprietary current steering technology for hearing that more closely resembles normal hearing. The newest AB electrode array, the HiFocus Mid-Scala electrode, was designed for optimal placement in the cochlea with low insertion force to protect its delicate structures. The HiFocus Mid-Scala electrode accommodates the latest soft surgery approaches, including round window insertion, to suit surgeon preferences and individual recipient needs. The patented design allows for ideal placement so recipients have the opportunity to hear the most pitches possible for enjoying music and improved speech understanding. The external component of the AB cochlear implant system includes a sound processor that sends signals via the headpiece to the internal component.   ]]> https://biospectrumindia.com/news/97/5570/cura-oxford-instruments-collaborate-to-develop-high-end-mri-equipment.html https://biospectrumindia.com/news/97/5570/cura-oxford-instruments-collaborate-to-develop-high-end-mri-equipment.html Thu, 05 Feb 2015 11:41:00 +0530 Oxford Instruments Healthcare, a division of Oxford Instruments that specializes in providing refurbished CT & MRI scanners, has partnered with South India-based CURA Healthcare to provide high-end refurbished imaging equipment to the Indian and Bangladesh markets. With this new partnership, Oxford Instruments Healthcare will expand into one of the fastest growing industries in India helping to provide affordable high-end MRI equipment to the country. Mr Bala Subramaniam, CEO of CURA Healthcare and his team will work alongside Oxford Instruments Healthcare to address India's growing demand by providing high quality ISO certified medical equipment backed by excellent after sales service and trained clinical applications team to support customers in India. CURA claims that this partnership is significant for India and Bangladesh customers as it is the first time a global medical device brand with high repute is partnering with an Indian company to satisfy the unmet needs of customers in both the countries. CURA is the manufacturer, supplier of specialty patented products like Dream ERA range of DR systems, mobile CR and other HF x-ray systems and is also into pre-owned equipment processing and marketing of high end imaging diagnostics systems including CT, MRI, Mammography and Bone Densitometer. The company's business verticals include manufacturing and supply of Digital X-ray solutions, Ultrasound/Color Doppler, Critical Care devices and supply of Pre-Owned CT, MRI, Mammography and BMD systems. ]]> https://biospectrumindia.com/news/97/5213/medical-device-industry-may-face-a-promising-future-in-india.html https://biospectrumindia.com/news/97/5213/medical-device-industry-may-face-a-promising-future-in-india.html Thu, 05 Feb 2015 09:32:00 +0530 India, a country with over 1.2 billion people, represents a significant proportion of the global population. Its nascent middle class and growing economy, combined with rising disease rates, present ample opportunities for healthcare companies to see steady growth, says Mr Shashank Settipalli, Analyst, GlobalData. Economic protectionism in the form of higher tariffs placed on raw material imports, and a historic lack of a robust regulatory framework contribute to market under-penetration of medical devices. However, The situation is slowly changing. In December 2014, the Indian government removed some barriers to the medical devices market, effectively allowing 100 percent foreign direct investment. The authorities took this decision to encourage local manufacturing and foster a greater potential for Indian companies to be acquired by major medical device players in the international arena. Additionally, Indian legislators are priming the healthcare regulatory apparatus for a drastic makeover. Lawmakers have drafted a 2015 bill amending the Drugs and Cosmetics Act to bring the import, manufacturing, distribution and sale of all medical devices under its purview. Harmonising and restructuring the regulatory frameworks assuages skepticism and uncertainties for medical device manufacturers. Furthermore, these actions encourage physicians to adopt more medical devices by enacting strong standards and benchmarks. These reforms may not cause instant success for medical devices in India, but are, nevertheless, reassuring first steps to growth in a burgeoning economy, according to GlobalData.   ]]> https://biospectrumindia.com/news/97/4093/samsung-unveils-a-new-ultrasound-system.html https://biospectrumindia.com/news/97/4093/samsung-unveils-a-new-ultrasound-system.html Wed, 04 Feb 2015 15:33:54 +0530 Samsung has introduced the Samsung WS80A, its flagship ultrasound product for women's healthcare, designed to streamline exam workflows and deliver exceptional image clarity. This high resolution premium system offers enhanced diagnostic capabilities and expanded 5D features, including a new 5D Heart application, building on Samsung's WS80A platform. "The launch of Samsung's flagship ultrasound product for the women's health market emphasizes Samsung is ready for the next big thing in ultrasound. The Samsung WS80A with Elite performance package incorporates Samsung's latest innovations, including an expanded set of 5D workflow applications, to continue our promise of delivering fast, easy and accurate diagnosis for healthcare providers and their patients," said Mr Doug Ryan, group vice-president for Health and Medical Equipment at Samsung. The Samsung WS80A with Elite's 5D Heart tool generates nine standard fetal cardiac views simultaneously in a single template, offering an intuitive workflow that can simplify examination of the fetal heart and improve reproducibility.     ]]> https://biospectrumindia.com/news/97/6160/iit-madras-establishes-bio-incubator-to-support-start-ups.html https://biospectrumindia.com/news/97/6160/iit-madras-establishes-bio-incubator-to-support-start-ups.html Wed, 04 Feb 2015 10:36:39 +0530 The Indian Institute of Technology (IIT) Madras - South India's premier engineering and research institution - has established an incubator for biotechnology start-ups to foster innovation and entrepreneurship in the southern region of India. The incubator was inaugurated on December 11, 2014 by Mr Bhaskar Ramamurthi, Director, IIT Madras. The bio-incubator is said to be ideal for budding entrepreneurs who need a nurturing environment to help bring their product to market and for companies who need a platform for trying new processes or technologies. The bio-incubator is open to researchers with a promising idea for a product that can be commercialized as well as start-up companies seeking to scale-up and enter the market. The IITM Bio-incubator is funded by the Biotechnology Industry Research Assistance Council (BIRAC), under the Bio-Incubator Support Scheme (BISS) of the Department of Biotechnology, India. IITM bio-incubator has been established with a primary objective of fostering Indian biotech innovation and entrepreneurship and it aims to enhance R&D capabilities of start-ups and SMEs in order to develop globally competitive products. The incubator offers lab and office space, high-end equipment, scale-up facilities, technical support and centralized utilities for process development to help technologies mature and attain commercialization. It is offered to researchers with nascent ideas, who want to develop processes and to commercialize their product, and also as an R&D base for companies to try new technologies. It is a platform for entrepreneurs to gain technical advice and researchers to realize business opportunities. The incubator can also be used to provide training and workshops to develop skills related to development and commercialization of the product. The bio-incubator offers a slew of other advantages to its incubatees. In association with the IITM Alumni Association's Entrepreneurship Forum, IITM Incubation Cell (IITMIC) will provide mentorship from IITM Alumni who have knowledge and experience relevant to the proposed project. Incubatees can avail the expertise in IITM in areas of biotechnology or business by consulting faculty members or research scholars. Business support is offered by IITMIC in areas of legal, accounting and company secretaryship. This can also include IPR services like patent mapping and patent applications. In terms of funding, the incubatees can get access to funding from the Entrepreneurship Support Scheme of the IITM Alumni as well as other venture capitalists and DST. In addition to these facilities, the incubatees can have access to a vast network of researchers, faculty, businessmen, industrialists, alumni, venture capitalists, governmental agencies and other service providers who can be tapped into via the bio-incubator. At present, the bio-incubator has inducted four incubatees for the first phase. Vital Bio-Scientific Solutions - a spin off from the Bioengineering and Drug Design lab, Department of Biotechnology, IIT Madras - is incubated by IITM Incubation Cell. Current focus of Vital Bio-scientific Solutions is to develop novel products and services for efficient screening of New Chemical entities (NCEs) and drugs in pre-clinical studies including ADME and toxicology. Dr Padma Priya, Research Scholar and Founder of Vital Bio-Scientific Solutions said, "Lack of efficient analytical instrumentation is an initial roadblock faced by most of the biotech start-ups, as it is expensive to set-up even a basic research lab. In such a scenario, the bio-incubator at IITM provides us with a high-end laboratory set-up that helps us to focus on product innovation, improvisation and commercialization. Most importantly the bio-incubator provides the necessary funds to establish a fully-equipped laboratory suitable for product development." Yaathum Biotech a start-up by four young students who have done their Masters in Biomedical field in UK, has been incubated with the aim of indigenously developing Real-time quantitative PCR (qPCR) kits for rapid/affordable diagnostic testing and research purposes. The company's current venture is to develop and market multiplex qPCR based diagnostic test kit that would make possible the identification of full range of Drug Resistant Tuberculosis (DR-TB) at one third the present cost, taking a few hours to test and capable of identifying all MDR and XDR-TB strains in a single test which is not available at present. FIB-SOL Life Technologies aims to develop efficient carrier systems for bio-fertilizers. Liquid bio fertilizers (LBF) and Fertilizer Carrying Membrane (FCM) are the two products developed at FIB-SOL, which, comprises of microbial formulations with improved stabilizers and carrier material. The products are aimed at improving the storage, application and logistics of bio fertilizers compared to currently available products. The company's Director Ms Kavitha Sairam indicated that, "The bio-incubator offers all conveniences under one roof. The incubatees have access to all sophisticated equipments and devices that is necessary for evaluating and validating our research product. Mentorship is most important for any research and the incubatees here are mentored academically and legally. The bio-incubator also offers assistance in guiding us to market the product and tackle issues faced by start-ups. At the end of three years, the incubatees can enter into a technology-transfer for the product or choose another product for development and commercialization." Purius Nanosystems Pvt. Ltd. is the fourth incubatee. The company is looking to develop point-of-care diagnostic devices for DNA-based testing that integrate semiconductor-based biosensors and microfluidics. IITM bio-incubator is open year round for fresh applications. A screening committee will evaluate the applications on several criteria, i.e. technical merit, proof of expertise, economic viability, funding and compatibility with the incubator. The start-ups are then incubated for a minimum period of three years. ]]> https://biospectrumindia.com/news/97/4992/icon-to-acquire-medimedia-pharma-solutions-.html https://biospectrumindia.com/news/97/4992/icon-to-acquire-medimedia-pharma-solutions-.html Wed, 04 Feb 2015 09:03:00 +0530 ICON has announced that it has agreed to acquire MediMedia Pharma Solutions for a cash consideration of $120 million. The deal is subject to certain customary closing conditions. MediMedia Pharma Solutions is owned by Vestar Capital Partners. MediMedia Pharma Solutions includes MediMedia Managed Markets and Complete Healthcare Communications. MediMedia Managed Markets is a leading provider of strategic payer-validated market access solutions. "The need to demonstrate and communicate the value of new medicines is an important global healthcare trend. Through ICON's market leading commercialisation and outcomes group, we are supporting our customers to maximise the value of their new drugs. Our acquisition of MediMedia Pharma Solutions deepens the expertise of this group and brings us outstanding scientific and medical communications capabilities," said Mr Ciaran Murray, ICON CEO. "The combination of the commercial, scientific, and market access expertise of MediMedia Pharma Solutions and ICON creates an unparalleled offering that can inform product investment decisions and establish and communicate product value. With the shift to evidence-based medicine and value-based pricing, we are excited about the expanded expertize and capabilities our relationship with ICON brings to our combined customers," said Mr Tim Search, president, MediMedia Pharma Solutions.   ]]> https://biospectrumindia.com/news/97/4406/new-software-analyzes-human-genomes-in-minutes.html https://biospectrumindia.com/news/97/4406/new-software-analyzes-human-genomes-in-minutes.html Tue, 03 Feb 2015 12:51:49 +0530 To overcome the challenges of analyzing that large amount of sequencing data, Researchers at the Nationwide Children's hospital have developed a computational pipeline called "Churchill". By using novel computational techniques, it allows efficient analysis of a whole genome sample in as little as 90 minutes. "Researchers can complete genomic sequencing in a matter of days. After a genome is sequenced, scientists are left with billions of data points to analyze before any truly useful information can be gleaned for use in research and clinical settings," said Dr Peter White, principal investigator and director of the Biomedical Genomics Core at Nationwide Children's and the study's senior author. Explaining about the software, Dr White said, "Churchill fully automates the analytical process required to take raw sequence data through a series of complex and computationally intensive processes, ultimately producing a list of genetic variants ready for clinical interpretation and tertiary analysis. Each step in the process was optimized to significantly reduce analysis time, without sacrificing data integrity, resulting in an analysis method that is 100 percent reproducible." The output of Churchill was validated using National Institute of Standards and Technology (NIST) benchmarks. In comparison with other computational pipelines, Churchill was shown to have the highest sensitivity at 99.7 percent; highest accuracy at 99.99 percent and the highest overall diagnostic effectiveness at 99.66 percent. According to the researchers, Churchill could be adapted for population scale genomic analysis.   The Churchill algorithm was licensed to Columbus-based GenomeNext, which has built upon the its technology to develop a secure and automated software-as-a-service platform that enables users to simply upload raw whole-genome, exome or targeted panel sequence data to the GenomeNext system and run an analysis that not only identifies genetic variants but also generates fully annotated datasets enabling filtering and identification of pathogenic variants. The company provides genomic data analysis solutions that simplify the process of data management and automate analysis of large scale genomic studies. The system was also developed with the research and clinical market in mind, offering a standardized pipeline that is well suited to settings where customers have to meet regulatory requirements. An article describing this software was published in the latest issue of Genome Biology.   ]]> https://biospectrumindia.com/news/97/4706/philips-teva-launch-medtech-incubator.html https://biospectrumindia.com/news/97/4706/philips-teva-launch-medtech-incubator.html Mon, 02 Feb 2015 12:26:15 +0530 Philips Healthcare and Teva Pharmaceutical Industries has launched Sanara Ventures, an incubator for Israeli MedTech and pharmaceutical companies with global aspirations. The companies are investing more than $25 million in the project over eight years. The incubator aims to fund and mentor startup companies with medical device and related technologies that complement drug development. Philips and Teva have earmarked up to NIS 100 million as initial investment over the next eight years to fund the participating companies, the newspaper said. "This unique cooperation between Teva and Philips expresses our faith in the important potential contribution of science and innovation in Israel in Teva's future directions and illustrates our commitment to operate and invest in Israel," said, Mr Erez Vigodman, Teva's president and CEO in a statement. "Israel has a major record of achievement in innovation, which Philips is a partner to through our extensive R&D investment in the country. I am convinced that this step will promote and strengthen even more healthcare innovation in Israel," said Royal Philips president and CEO, Mr Frans van Houten, in a statement.       ]]> https://biospectrumindia.com/features/97/4405/ayurgenomics-raises-new-hopes-for-patients.html https://biospectrumindia.com/features/97/4405/ayurgenomics-raises-new-hopes-for-patients.html Sun, 01 Feb 2015 09:30:00 +0530 How often have you seen well qualified genomic researchers reciting centuries old Vedic hymns while explaining their research work? Perhaps never because of it being stereotyped into something mysterious! But here is an example of a research team that has been working quietly for last one decade on a unique initiative to find resemblances between genomics and Ayurveda. Named the TRISUTRA (Translational Research and Innovative Science Through Ayurveda), it is basically a unit of the Council for Scientific and Industrial Research(CSIR) functional at its Institute of Genomics & Integrative Biology (IGIB), New Delhi. The research focus of the Unit comprising of a small team, is to develop affordable health care solutions through integration of traditional knowledge of Ayurveda, genomics and modern medicine. To begin with, the survey questionnaire with eleven queries on the TRISUTRA's site asks few basic questions on the Ayurveda, testing the knowledge and preferences of common Indians on the subject. Apart from the basics, the Unit has been working with the hospitals, tertiary referral centres, and academic institutions to create a network of multi-disciplinary research efforts. Among these are the Indian Statistical Institute, Kolkata; Ganit Labs, Bangalore; National Centre for Biological Sciences, Bangalore; Maharishi Dayanand University, Haryana; along with host of Ayurveda and public institutes in India. The network has also aligned globally with the Georgia Technology University, Atlanta. Whether or not the Ayurveda can prove to be an effective scientific tool for treating bodily ailments is highly debatable but what certainly cannot be ignored or underestimated is its continued acceptability in the remote parts of India since ages. The critics may find it quite complex but then complexities lead to discoveries. Isn't it? So why has been the cross talk between Ayurveda, modern medicine and genomic science been avoided so far? A peep into past  While it was conceptualized long back in 2002 by Dr Samir Brahmachari, former director general of CSIR and his team, the recognition came as late as in 2008 when a landmark study, the first of its kind in the world, revealed that it is possible to identify groups within normal individuals of the populations, which could be predisposed to certain kind of diseases, and also might respond differently to drugs. This is also when the word 'Ayurgenomics' was coined by the authors of the study. Based on one of the leads from gene expression differences, a genetic marker associated with high altitude adaptation and a high altitude illness, EGLN1 was identified. The study thus provided a novel molecular framework for integration of two contrasting disciplines. Recalling the days when nobody was even talking about it, Dr Brahmachari mentioned, "When we imagined this project back in 2001, our knowledge was zero. But we realized that the genomic research is moving towards predictive personalized medicine. Therefore, we thought ahead of times and established a network of scientists to explore the existing traditional knowledge ignored so far. The principle we are using is very similar to the sub-group classification employed 4000 years back in Ayurveda."   Dr Brahmachari feels that despite adverse opinions at times, one has to take the risk and be persistent with the ideas to gain experience. "It is important to remember that 1.3 billion population of India cannot be treated by the modern medicine when 65 percent of them are still dependent on traditional medicine in one way or the other. So, why not use this to identify the genetic connection of fruits/foods suitable for the disease phenotypes. The core focus is on the affordability and creation of flipcart like mechanism where the delivery of customized medicine is possible through telemedicine facilities, " he said further. The results of the study led by Dr Mitali Mukerji, senior scientist at the IGIB were reported in the Journal of Translational Medicine in September, 2008. Other members of team, Dr Bhavana Prasher an Ayurveda expert and Dr Sapna Negi a senior molecular biologist co-authored the paper along with a team of trans-disciplinary people that included Ayurveda doctors, molecular biologists, biochemists, bioinformaticians and statisticians. This study explored whether this ancient and documented system of Prakriti analysis could be correlated in modern biology terms. For this purpose, more than 1000 individuals were screened, out of which 120 individuals of predominant prakriti were identified, and subsequently 96 unrelated ethnically matched healthy individuals with predominance of either Vata (39 individuals), Pitta (29) or Kapha (28) prakriti, belonging to an age group of 18 - 40 years with equal numbers of both genders (n=48 in each case) were recruited for further analysis. "In the study, normal individuals of the three most contrasting Prakriti types, namely, Vata, Pitta and Kapha, were identified following clinical criteria described in Ayurveda in Indian population of Indo-European origin. It was observed that these Prakriti types exhibited differences at biochemical profiles like liver function tests and lipid profiles and hematological parameters like haemoglobin level etc. Differential gene expression was found in significant number of housekeeping and disease related genes. A significant variation in expression of genes related to metabolism, transport, immune response and regulation of blood coagulation etc. was also observed," says Dr Mitali Mukherji, Programme Director & Principal Investigator(Genomics). When asked about the Ayurveda's predictive medicine connection, Dr Bhavana Parasher, senior scientist and principal investigator (Ayurveda) remarked, "According to Ayurveda, an individual's basic constitution, Prakriti, to a large extent, determines predisposition and prognosis to diseases as well as suitability of preventive and curative regimen for the same. The research can become the fertile land for newer discoveries and also start looking at specific diseases from inter-individual variablility point of view for personalized solutions " Having begun on modest funding, there is no dearth of funding for the team now. "It has increased over time and right now our focus is on collecting more and more data from research besides building longterm resources. We had to start from scratch and since past one year, there have been multiple workshops across five sites in India. 2000 to 3000 people have been analysed at each centre so far and it will take another one and half year," says Dr Mitali.   Potential to be future of predictive medicine Though many believe that it is just hype and no substance, there is no dearth of people who feel it has potential. "I strongly believe that the PM call of "made in India" requires identification of areas where we have strategic advantages & "Ayurgenomics" fits the bill perfectly. We can lead the world here and pave way to usher a new era of healthcare which is based on our rich traditional knowledge and modern scientific scrutiny says Praveen Gupta, executive director, Premas Biotech that represents the genomic sequencing technology company, Illumina in India. The government's mood to promote Ayurveda can be well gauged from the scale of World Ayurveda Conference that was organized at New Delhi in November. Infact, the ministers and health officials are openly batting for it. "Promotion of Ayurvedic medicine system backed with scientific reasons can put India on world map. India can lead the world by promoting its ancient and preventive system of ayurvedic medicine duly backed by scientific reasons which can put us on the global map just like yoga. Our own system which has been prevailing since thousands of years can put a great impact in the world and people can be prevented from many dreaded diseases, treatment of which otherwise costs very high," said Dr Jagdish Prasad, director general of health services, Ministry of Health and Family Welfare at an event in Delhi. The focus on Ayurgenomics assumes significance because it holds the potential to bring the scientific credence and global acceptability to Ayurveda. If successful, it can also provide new leads to genomics and help create customized products that can be utilized by the biopharma, nutrition and Ayurveda industry. At the times, when millions are spent to find the new chemical entities and further research, there seems to be no reason for being biased towards an indigenous science left unexplored. ]]> https://biospectrumindia.com/news/97/4010/esi-bio-and-2bscientific-ink-pact.html https://biospectrumindia.com/news/97/4010/esi-bio-and-2bscientific-ink-pact.html Sat, 31 Jan 2015 10:34:00 +0530 ESI BIO, the stem cell products division of BioTime, announces that its cGMP and research grade stem cell lines, reagents and cell matrix products are now available in the UK and Ireland through 2BScientific. ESI BIO's research products include clinical and research grade human embryonic stem cells from ES Cell International (ESI) and HyStem hyaluronan-based hydrogel extracellular matrices. It also provides unique PureStem Embryonic Progenitors, antibodies and small molecules for stem cell differentiation and reprogramming. Mr Jeffrey Janus, CEO, ESI BIO said, "We are pleased to hear that 2BScientific would like to be our distributor in the UK market and we expect that we can build a strong partnership in the future." Mr James Bernard, CEO of 2BScientific added, "2BScientific is excited to have signed a distribution agreement with ESI BIO to sell all of their stem cell products and services in the United Kingdom and Ireland. We are excited to offer their cell lines and supporting products for stem cell researchers."   ]]> https://biospectrumindia.com/news/97/4269/roche-collaborates-with-qualcomm-.html https://biospectrumindia.com/news/97/4269/roche-collaborates-with-qualcomm-.html Fri, 30 Jan 2015 12:59:13 +0530 Qualcomm's subsidiary, Qualcomm Life and Roche has announced that they have entered into a strategic collaboration to improve remote monitoring and management of chronic disease patients. The companies aim to advance chronic care management using connected therapy to further improve therapy quality, increase convenience and drive patient engagement in managing their health. Roche will utilize Qualcomm Life's 2net Platform to seamlessly and securely capture data from a patient's medical devices, beginning with anticoagulation meters, and transmit it to Roche's cloud-based back-end services. The 2net Platform is a secure wireless solution that provides a simple and efficient way to exchange relevant health information between chronic disease patients and their care team or clinic to enable reduced therapy complications and total cost of care. Qualcomm Life and Roche are working together to deliver an improved process for sharing health information between health care providers and their patients. "This collaboration marks a significant milestone for Roche as we launch a new generation of point-of-care solutions that enable healthcare professionals to better keep in touch remotely with patients, whenever and wherever they are," said Mr Jeremy Moss, senior vice president, Point of Care at Roche Professional Diagnostics. He added, "By combining Qualcomm Life's leadership in powering connected health solutions with our point-of-care expertise, we are taking an important step forward to realize our connected care strategy; ultimately enabling physicians to improve the overall quality of life for patients." "We are thrilled to be working with a global industry leader in diagnostics and excited by the positive impact our collaboration with Roche can have on patient empowerment at the point-of-care. Together, Roche and Qualcomm Life are committed to providing tools to patients and their physicians and caregivers that empower greater coordination to improve patient health," said Mr Rick Valencia, senior vice president and general manager, Qualcomm Life.   ]]> https://biospectrumindia.com/news/97/4263/jj-signs-mou-with-insuline-medical.html https://biospectrumindia.com/news/97/4263/jj-signs-mou-with-insuline-medical.html Fri, 30 Jan 2015 12:58:31 +0530 According to reports, InsuLine Medical has signed a memorandum of understanding (MoU) with Johnson and Johnson (J&J). Under the MoU, InsuLine and J&J will cooperate in obtaining regulatory approval for marketing InsuPad. InsuPad is a medical device which reduces injected insulin uptake speed in diabetics by near 50 percent. J&J will also manage registration procedures with the various authorities. Once regulatory approval for marketing is obtained, the parties will negotiate a final binding distribution agreement for each territory, in which J&J will be the sole distributor. In addition to Russia, the agreement will also include Ukraine and other former Soviet Union countries Belarus, Armenia, Azerbaijan, Georgia, Kazakhstan, Kirgizstan, Moldova, Tajikistan, Turkmenistan, and Uzbekistan. The registration procedure is likely to take a year. "InsuLine is continuing the expansion of the markets to which it sends the company's products, in line with its global commercial strategy. It is important to stress that the Russian market is a large and significant market for InsuLine, and the cooperation will include planning, management, and carrying out penetration strategy," said Mr Michael Netz, CEO InsuLine, in a statement.   ]]> https://biospectrumindia.com/news/97/4096/usfda-springs-to-action-to-improve-aeds-reliability.html https://biospectrumindia.com/news/97/4096/usfda-springs-to-action-to-improve-aeds-reliability.html Thu, 29 Jan 2015 13:04:17 +0530 Automated external defibrillators are portable, electronic medical devices that automatically sense potentially life-threatening cardiac arrhythmias and either automatically deliver or advise the user to deliver electrical stimulation to re-establish normal heart rhythms. They are often stored in public locations for use in an emergency and, while they can be lifesaving, there has been a history of malfunction issues. The FDA issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these devices in the past. The agency's strengthened review will focus on the critical requirements needed to ensure the safety and reliability of AEDs and their necessary accessories, including batteries, pad electrodes, adapters and hardware keys for pediatric use. "Automated external defibrillators save lives," said Mr William Maisel, deputy director for science, chief scientist and acting director of the office of device evaluation in the FDA's Center for Devices and Radiological Health. "These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices."   From January 2005 through September 2014, the FDA received approximately 72,000 medical device reports associated with the failure of these devices. Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs. The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers. By requiring premarket approval for these devices, the FDA will receive important information about an AED manufacturer's quality systems information. The FDA will also conduct inspections of manufacturers' facilities prior to approval. After approval, manufacturers will be required to submit to the FDA any changes made to the devices that affect safety or effectiveness, and annual reports on device performance. Given the importance of these devices in emergency situations, AEDs currently on the market will remain available while manufacturers work to meet the new PMA requirements. The FDA does not intend to enforce the PMA requirement for AEDs until July 29, 2016, as long as manufacturers notify the FDA of their intent to file a PMA by April 29, 2015. The FDA does not intend to enforce the PMA requirement for currently marketed, necessary AED accessories until January 29, 2020. The Food and Drug Administration Safety and Innovation Act calls for the FDA to publish proposed and final orders to reclassify or call for PMAs for pre-amendments devices. The FDA's Circulatory System Devices Panel recommended that AEDs remain Class III medical devices and require PMAs. The FDA originally issued a proposed order in March 2013 calling for PMAs to ensure the appropriate regulation of Class III pre-amendments devices. ]]> https://biospectrumindia.com/news/97/6491/biotime-secures-14-new-patents.html https://biospectrumindia.com/news/97/6491/biotime-secures-14-new-patents.html Thu, 29 Jan 2015 10:29:00 +0530 BioTime has announced the issuance of 14 new patents covering a wide range of the core technologies of BioTime and its subsidiaries Asterias Biotherapeutics, OrthoCyte Corporation, ES Cell International, OncoCyte Corporation, and ReCyte Therapeutics. The new patents issued over Q3 and Q4 of 2014 add to the BioTime family of companies' patent estate of over 600 patents and patent applications pending worldwide, which is the largest known patent estate in the field of pluripotent stem cell technology for human therapeutic application, also known as regenerative medicine. "BioTime and its subsidiaries are focused on developing and commercialising a broad portfolio of innovative cellular therapeutics and diagnostic products, while also continuing to build value in other ways, such as through the addition of new patents to our industry-leading intellectual property estate," said Dr Michael D West, BioTime's CEO. He added, "We are making significant strides in patenting our core platform of pluripotent stem cell technology and strengthening our competitive position in regenerative medicine. We plan to utilize our strengthened patent position to drive value for our shareholders as the field of regenerative medicine begins to address the large and growing markets associated with chronic and age-related degenerative disease." The New Patents Owned by BioTime or one of its subsidiaries are European patent 1809739, Canada patent 2559854 and China patent ZL200580008779.0, South Korea patent 1543500B , Canada patent 2468335, Israel patent 208116, Singapore patents 18809, 176957 and 177694, Australia patents 2011258249,00735127, Israel patent 179785, and in-licensed Patents, United States patent 8921104 and 8,815804.   ]]> https://biospectrumindia.com/news/97/1190/trivitron-enters-a-joint-venture-with-imd-generators.html https://biospectrumindia.com/news/97/1190/trivitron-enters-a-joint-venture-with-imd-generators.html Wed, 28 Jan 2015 12:51:43 +0530 Trivitron Healthcare has announced a joint venture (JV) with the IMD group, Italy. The companies has signed an MoU for the joint venture in the name of Kiran IMD X Ray, to design/develop and manufacture variety of X Ray Equipment and X-Ray accessories based out of its facilities in Chennai and Mumbai â€?in India and Bergamo in Italy. Trivitron healthcare holds 60 percent share while IMD group holds 40 percent share in this venture. Through this collaboration, the companies will manufacture X Ray Monobloc, X Ray Generators, High Frequency X Ray Machines, Mobile and Full Room DR, Digital OPG and Mobile Cathlab. Dr GSK Velu, founder and managing director of Trivitron Group, said " We are also happy that this JV is being announced in Arab Health 2015, the world's largest Medical Technology fair where Trivitron has been a significant partner for over 8 years now." "This is an exciting moment for Kiran Medical Systems as we move up in our value chain to provide more comprehensive product line to our channel partners and customers across the Globe. IMD and Kiran products are complimentary to each other and the JV will immensely benefit both companies," said CEO of Kiran Medical Systems, Mr â€?Ramesh Modi. Mr Aliberti the CEO of IMD Group of Companies said, "Bringing Trivitron/ Kiran and IMD's expertise and network together will ensure more comprehensive product offerings to the focus markets in a most cost effective basis."   This joint venture between Kiran and IMD ensures â€?these high technology products will be manufactured in India for making it accessible and affordable to larger section of population with special emphasis to emerging markets like South and South East Asia, Middle East and Africa, Eastern Europe and Latin America. The JV will also produce Monoblocs/ Generators to be supplied to other X Ray manufacturers across the world using Kiran's Global Network.   ]]> https://biospectrumindia.com/news/97/4182/google-teams-up-with-biogen.html https://biospectrumindia.com/news/97/4182/google-teams-up-with-biogen.html Wed, 28 Jan 2015 12:29:48 +0530 Google X, the lifescience division of google has joined hands with drugmaker Biogen to study environmental and biological contributors to multiple sclerosis (MS), says reports. Using sensors, software and data analysis tools, the companies will collect and sift through data from people with the disease. Their goal is to find out why multiple sclerosis progresses differently from patient to patient. Biogen already has five MS drugs in the market and is on a mission to use new technologies to gather round-the-clock data on patients. The collaboration deepens Google's commitment to the health industry. Last year, Google X had collaborated with Novartis for smart contact lens project for diabetes.   ]]> https://biospectrumindia.com/news/97/6321/siemens-shuffles-its-management-board.html https://biospectrumindia.com/news/97/6321/siemens-shuffles-its-management-board.html Wed, 28 Jan 2015 12:28:51 +0530 Siemens AG has announced major changes in its healthcare management board. The company said that Mr Hermann Requardt is stepping down from the board and his position as Healthcare CEO by mutual consent to enable a generation change. Mr Bernd Montag, currently the CEO of Imaging and Therapy Systems at Healthcare, will  succeed him. Mr Requardt, however will remain available in an advisory capacity. The company named Mr Michael Reitermann, currently the CEO of Healthcare's Diagnostics business, as a member of Executive Management and Mr Michael Sen, chief financial officer of the Healthcare business, which is separately managed within Siemens AG. Mr Michael Sen is currently Healthcare CFO. The company also announced that Mr Siegfried Russwurm will be the Board-level partner for the separately managed Healthcare business, while retaining his regional responsibilities for the CIS and Middle East as well as his position as chief technology officer. Mr Joe Kaeser, president and CEO of Siemens AG, said, "I have the greatest respect for Mr Requardt's decision to make way for a generation change. We are now setting up Healthcare as a separately managed business within Siemens in order to pave the way for an equally successful future in a highly dynamic market and innovation-driven environment. This is now the task of Bernd Montag, Michael Reitermann and Michael Sen. They will have the full support of the Managing Board and their direct partner, Board member Mr Siegfried Russwurm, who worked in the company's former Medical Engineering and Medical Solutions units for ten years." All changes will take effect from February 1, 2015.   ]]> https://biospectrumindia.com/news/97/4174/us-fda-drafted-guidelines-for-wellness-medical-devices.html https://biospectrumindia.com/news/97/4174/us-fda-drafted-guidelines-for-wellness-medical-devices.html Tue, 27 Jan 2015 13:06:27 +0530 The United States Food and Drug Administration (US FDA) has issued two draft guidance documents outlining how the agency would classify low-risk general wellness devices and applications. It has also proposed risk assessment-based regulation for medical device accessories. According to the proposed guidance, the FDA intends to regulate a general wellness product when it is marketed for a specific disease or condition. Devices that are more intrusive and involve more than tracking of exercise, diets and heart rates would require more regulatory oversight. Devices are not considered general wellness if they purport to treat or diagnose obesity, anorexia, anxiety, muscle atrophy or erectile dysfunction. Also, computer games that claim to diagnose or treat autism do not fall under the definition of a general wellness product. The regulatory body in a draft guidance defined a medical device accessory as something that is used with at least one parent device or is intended to support, supplement and/or augment the performance of one or more parent devices. The accessories will be regulated based on the risks they present when used with their parent devices, but not based on the parent device's risks. The agency noted that some device accessories can have lower associated risks than their parent devices, and thus warrant different levels of regulation.     ]]> https://biospectrumindia.com/news/97/5866/medtronic-completes-acquisition-of-covidien.html https://biospectrumindia.com/news/97/5866/medtronic-completes-acquisition-of-covidien.html Tue, 27 Jan 2015 13:04:59 +0530 Medtronic has announced that it has successfully completed the acquisition of Covidien. Under the terms of the acquisition agreement, Medtronic and Covidien are now combined under Medtronic Shares of Medtronic and are expected to begin trading on the New York Stock Exchange (NYSE) under the symbol "MDT" on January 27, 2015. "The culmination of this acquisition marks a significant milestone in our industry. We can now bring together the extensive and innovative capabilities of both Medtronic and Covidien with an underlying objective to solve healthcare's biggest challenge, expanding access and improving clinical outcomes, while lowering costs," said Mr Omar Ishrak, chairman and CEO of Medtronic. He added, "We know that our combined businesses can have a real and meaningful impact on people's lives, helping to treat more people, in more ways and in more places around the world." Under the terms of the transaction, each ordinary share of Covidien outstanding as of the closing has been converted into the right to receive $35.19 in cash and 0.956 of an ordinary share of Medtronic.     ]]> https://biospectrumindia.com/news/97/8062/mri-systems-market-value-to-double-by-9-2-billion-by-2020.html https://biospectrumindia.com/news/97/8062/mri-systems-market-value-to-double-by-9-2-billion-by-2020.html Tue, 27 Jan 2015 11:54:00 +0530 The company's latest report states that this impressive growth will be driven by continual design developments, cost reductions, reimbursement improvements and the rapid uptake of less expensive MRI systems in emerging markets. However, Mr Rob Littlefield, GlobalData's senior analyst covering medical devices, says current economic factors remain the greatest threat to new innovation in the next five years, despite numerous advancements in MRI system capability. Mr Littlefield explains, "This is especially true in western Europe, where economic austerity measures are stalling device purchases of every category. However, many hospitals still uncompromisingly demand advanced MRI systems despite tight budgets, so significant growth opportunities remain." "Healthcare providers are calling on manufacturers to develop both cheaper and better technology, meaning suppliers' success will depend on the development of MRI solutions offering improvements in cost, efficiency and workflow, while also enhancing clinical diagnostics," he adds. GlobalData's report also finds that market growth for MRI systems in the US and EU will continue to be heavily dependent on the replacement of existing systems that are nearing the end of their lifetime.   Mr Littlefield continues: "Despite the need for replacements, hospitals do not always decommission MRI systems at the end of the products' manufacturer-recommended lifecycles, which negatively affects sales in these developed markets as new system purchases are delayed or abandoned. Additionally, newer systems are expected to cost less, reducing manufacturers' profit margins and resulting in a highly competitive MRI market that ultimately stifles new product innovation." The analyst adds that sales growth in emerging countries, such as China and India, will be fueled by the rapid uptake of less-expensive MRI systems that will allow access to healthcare in more remote areas of these price-sensitive economies. "With increases in average income, growing demand for healthcare, and higher standards for care, emerging markets are expected to see a rise in MRI diagnostic procedures, as the technology offers safe and valuable insight into patient conditions and is a powerful, irreplaceable decision-making tool for physicians," concludes Mr Littlefield. ]]> https://biospectrumindia.com/news/97/6909/transgenomic-introduces-ice-cold-pcrtm-.html https://biospectrumindia.com/news/97/6909/transgenomic-introduces-ice-cold-pcrtm-.html Sun, 25 Jan 2015 10:05:00 +0530 Transgenomic has announced the commercial launch of its Multiplexed ICE COLD-PCRTM (MX-ICP) product line. The launch itself is scheduled for the first quarter of 2015. MX-ICP is an ultra-high sensitivity DNA amplification technology that allows the simultaneous detection of multiple mutations in multiple genes from either tumor or liquid samples, such as blood or urine, on all platforms. Multiplexed ICE COLD-PCR delivers major advantages compared to current sequencing technologies used on their own. It delivers at least a 100-fold improvement in sensitivity, detecting previously unknown genetic alterations along with those that are already known. Its ultra-high sensitivity makes it feasible to conduct comprehensive genomic analysis using either tissue or liquid biopsies, by accurately analyzing cell-free tumor DNA circulating in the blood or other bodily fluids. MX-ICP is platform agnostic, it works on all the sequencing platforms found in labs,greatly enhancing the sensitivity of next-generation sequencing, Digital PCR, Sanger, and other platforms. It is easy to use, highly reliable and can be easily implemented, requires minimal disruption to current sequencing processes or procedures. Mr Paul Kinnon, president and CEO, said, "Personalized cancer treatment is an idea whose time has come, as our rapidly increasing ability to understand the disease based on its distinctive genomic features is matched by advances in detection and monitoring technologies and innovative new therapies. We accordingly are pleased to announce that we will be launching our Multiplexed ICE COLD-PCR technology this quarter, since we believe that MX-ICP is the first technology that can make personalized medicine a practical reality. Its ultra-high sensitivity, ability to work in tandem with all current sequencing technologies, ease of use, and cost effectiveness have the potential to ensure that the benefits of personalized cancer therapy become widely available to cancer researchers and drug developers, as well as to patients and their healthcare providers."       ]]> https://biospectrumindia.com/news/97/5365/thermo-fisher-cynvenio-ink-pact-for-liquidbiopsy-platform.html https://biospectrumindia.com/news/97/5365/thermo-fisher-cynvenio-ink-pact-for-liquidbiopsy-platform.html Sat, 24 Jan 2015 10:50:00 +0530 Thermo Fisher Scientific has announced that it has signed an agreement with Cynvenio Biosystems for rights to distribute its LiquidBiopsy platform. The addition of Cynvenio's rare cell enrichment technology complements Thermo Fisher's Ion Torrent Personal Genome Machine (PGM) workflow and positions the company as the only one in the industry to offer a comprehensive sample-to-genomic data solution for research using a single blood draw for analysis of circulating tumor cells (CTC), cell-free DNA (cfDNA) and normal DNA in less than 48 hours. The workflow enables researchers to conduct highly multiplexed analyses on serially collected blood samples. Mr André de Fusco, CEO, Cynvenio said, "As a company, we are dedicated to facilitating a new era of individualized medicine. To that end, we see incredible value that our platform and Thermo Fisher's next generations sequencing workflow can bring to translational researchers globally." "In our evaluation of peripheral monitoring technologies on the market, Cynvenio's LiquidBiopsy platform offers the most compatible addition to our next generation sequencing workflow, particularly as it applies to our evolving oncology strategy. The agreement with Cynvenio also underscores our commitment to provide our oncology research customers with innovative tools to help advance the future of cancer care," said Mr Chris Linthwaite, president, Genetic, Medical and Applied Sciences, Thermo Fisher Scientific. Cynvenio's liquid biopsy platform as well as the Ion Torrent PGM, Ion Torrent Chef and AmpliSeq Cancer Hot Spot Panel v2 are For Research Use only. Not for use in diagnostic procedures.   ]]> https://biospectrumindia.com/news/97/5231/a-new-confocal-laser-scanning-microscope-by-zeiss.html https://biospectrumindia.com/news/97/5231/a-new-confocal-laser-scanning-microscope-by-zeiss.html Sat, 24 Jan 2015 10:42:00 +0530 ZEISS has introduced a new compact confocal laser scanning microscope for high-end confocal imaging, ZEISS LSM 800. With highly sensitive GaAsP (Gallium arsenide phosphide) detector technology and fast linear scanning, the new microscope provides high image quality and offers enhanced productivity and throughput, as well as greater flexibility in live cell imaging. The optional Airyscan module delivers 1.7 times higher resolution and higher sensitivity than conventional confocal microscopes. ZEISS LSM 800 is continually monitoring and calibrating the scanner position to guarantee a stable field of view and equal pixel integration times over the whole field of view. The patented linear scanning regime gives a constant signal-to-noise level and uniform exposure to the illuminating laser throughout the scanned area, including manipulated regions of interest. Gallium arsenide phosphide photomultiplier tubes (GaAsP PMTs) display high light collection efficiencies over a broad spectral range. Their low dark noise levels also make them the ideal tool for detecting faint signals in low expressing cells. The gain in signal-to-noise ratio (SNR) will increase productivity by achieving faster scan speeds while preserving high image quality. Low laser powers avoid photobleaching and phototoxicity in live cell imaging applications. It requires minimal setup requirements, maintenance, and self-calibration paired with low overall energy consumption.   ]]> https://biospectrumindia.com/news/97/5944/illumina-launches-ngs-solution-for-forensic-genomics.html https://biospectrumindia.com/news/97/5944/illumina-launches-ngs-solution-for-forensic-genomics.html Thu, 22 Jan 2015 13:04:35 +0530 Illumina has announced the launch of the MiSeq FGx Forensic Genomics System, the first fully validated forensic next-generation sequencing (NGS) system. The new system simultaneously interrogates short tandem repeats (STR) and other valuable genetic markers, including single nucleotide polymorphisms (SNPs), to provide informative DNA profiles. The system enables more robust analysis of a broader range of genetic markers in a single workflow than previous technology allowed, supporting the reliable analysis of both routine and challenging forensic DNA samples. Designed in collaboration with leading forensic genomics and human identification experts, the MiSeq FGx System leverages Illumina's sequencing by synthesis (SBS) chemistry. Compatible with existing DNA databases, including the Combined DNA Index System (CODIS), the system can be used for criminal casework and in a range of situations, including mass disasters, missing persons, and unidentified human remains. In addition to the MiSeq FGx DNA sequencer, the system includes the ForenSeqTM DNA Signature Prep Kit and ForenSeq Universal Analysis Software. This sample-to-answer solution will enable labs to maximize the information derived from a sample, generating more data from a single test than previously possible, and eliminating the need for multiple rounds of partial, iterative testing. "Several years ago, Illumina assembled an experienced forensic team and challenged them to develop a solution leveraging our technology to revolutionize the way forensic laboratories process and resolve their cases", said Mr Matt Posard, senior vice president and general manager, New and Emerging Opportunities, Illumina. "Together with input from the global forensic DNA community, we are proud to launch the MiSeq FGx Forensic Genomics System. We expect it will be used to alleviate the mounting backlog of investigative samples, helping to solve cold cases, and exonerate the innocent," he added.   ]]> https://biospectrumindia.com/news/97/5889/jj-sharing-medical-device-trial-data-with-yoda.html https://biospectrumindia.com/news/97/5889/jj-sharing-medical-device-trial-data-with-yoda.html Thu, 22 Jan 2015 12:02:42 +0530 Johnson & Johnson (J&J) has announced that it would share clinical trial data on its medical devices and diagnostics with the Yale University Open Data Access (YODA) Project. The results from the clinical trials of the Medical Devices and Diagnostics businesses of J&J will be made available to researchers. This establishes a fully independent intermediary to manage requests and promote data use, just as it has done with its pharmaceutical clinical trial data. The YODA Project will continue to act as a bridge between investigators and J&J 's pharmaceutical, and device and diagnostics businesses. Under the arrangement, the YODA Project will approve or deny requests from investigators for de-identified patient data associated with the pharmaceutical, medical device, and diagnostic clinical trials conducted by J&J companies. This expanded scope that now includes device and diagnostic studies is another step forward in the continuing evolution of open science in clinical medicine. "This action will benefit society and represents a major step forward in the effort to promote data sharing, as J&J leadership in this area now extends from sharing its drug data to sharing its device and diagnostics data. We hope this action serves as a catalyst to others to join the momentum on open science," said Dr Harlan Krumholz, professor of medicine and leader of the YODA Project. Dr Joanne Waldstreicher, chief medial officer of J&J said, "Sharing data from clinical trials leads to greater insights in medicine. This agreement with the YODA Project underscores J&J's commitment to responsibly share clinical trial data with researchers in a way that we believe advances medical science and public health."   ]]> https://biospectrumindia.com/news/97/6786/thermo-fisher-expands-its-oncology-portfolio.html https://biospectrumindia.com/news/97/6786/thermo-fisher-expands-its-oncology-portfolio.html Wed, 21 Jan 2015 12:25:28 +0530 Thermo Fisher Scientific has released a next-generation sequencing (NGS) RNA panel and workflow that enables targeted sequencing of fusion transcripts for clinical research. The new Ion Torrent AmpliSeq RNA Fusion Lung Cancer Research Panel allows simultaneous sequencing of 70 ALK, RET, ROS1, and NTRK1 fusion transcripts associated with lung cancer as well as 5' and 3' ALK gene expression. The panel was verified by leading clinical researchers from the OncoNetwork Consortium spanning 10 different countries around the globe and years of experience in adopting NGS technologies to pioneer colon and lung cancer research. "The introduction of the Ion Torrent AmpliSeq RNA Fusion Lung Cancer Research Panel is representative of our commitment to bring new and innovative applications to the oncology community to advance clinical and translational research," said Mr Mark Stevenson, president of Life Sciences Solutions at Thermo Fisher Scientific. The company also launched CE-IVD Oncomine Solid Tumor DNA kit that enables highly accurate and reliable multiplexed sequencing of formalin-fixed, paraffin embedded (FFPE) tumor samples with the quality and performance needed for the clinical laboratory. The kit allows detection of single nucleotide somatic changes, inversions, insertions, and deletions using as little as 10ng of FFPE DNA, enabling laboratory clinicians to analyze samples that may contain partially degraded or limited tumor material, and generate reportable results from more samples than previously possible with lower acceptance thresholds for FFPE tumor DNA. "The development and commercialisation of the CE-IVD Oncology Solid Tumor DNA kit in the European Union is representative of our continued commitment to enabling our customers to advance clinical oncology care while meeting regional regulatory requirements," said Mr Stevenson.   ]]> https://biospectrumindia.com/news/97/5260/illumina-expands-its-ngs-portfolio.html https://biospectrumindia.com/news/97/5260/illumina-expands-its-ngs-portfolio.html Wed, 21 Jan 2015 12:18:18 +0530 Illumina has expanded its next-generation sequencing (NGS) portfolio with the launch of its HiSeq X Five System and HiSeq 3000/4000 Systems. The new systems bring to market technology innovations and cost reductions that enable high-throughput laboratories to significantly increase their productivity. The NextSeq 550 System, the first NGS system enabled for array scanning. The system's initial applications are for cytogenetics and prenatal genetic diagnosis (PGD). The company also unveiled a roadmap for further market expansion in the areas of reproductive health and oncology. "Illumina technology has broken down barriers in genomics by increasing data throughput at an astounding rate, while at the same time dramatically reducing the price per data point," said Mr Jay Flatley, CEO, Illumina. He added, "These advancements enable us to deliver the industry's simplest, most efficient sequencing experience to our research and clinical customers as they work to forever transform our understanding of genomics and medicine." The HiSeq X Five, HiSeq 3000/4000, and NextSeq 550 Systems are now available for order. Sharing its strategies and innovations for market expansion the company said it will launch the VeriSeq NIPT Solution in Europe in Q2'15. The 48-sample non-invasive prenatal test (NIPT) assay, based on paired-end sequencing, offers significant workflow and cost benefits by eliminating the need for PCR. The company also announced a circulating tumor DNA development program to address the significant research and clinical opportunity for better understanding and improving cancer treatment and drug response. It plans to release research use only kits in 2015, and operate a laboratory developed test to gather clinical evidence for regulatory submission and work with key partners. It is also planning to update the intended use for the MiSeqDx for use with FFPE samples. ]]> https://biospectrumindia.com/news/97/5262/cap-accreditation-for-beckman-coulter-genomics.html https://biospectrumindia.com/news/97/5262/cap-accreditation-for-beckman-coulter-genomics.html Wed, 21 Jan 2015 11:43:10 +0530 Beckman Coulter Genomics has announced an accreditation from the College of American Pathologists (CAP). Its facility in Danvers completed a comprehensive on-site inspection as a part of the CAP's accreditation program. The CAP Laboratory Accreditation Program involves a process of inspections of clinical lab records and quality control procedures and assessments of a lab's staff qualifications, equipment, facilities, safety program, and overall management. "Beckman Coulter Genomics is proud to achieve accreditation from the College of American Pathologists. CAP accreditation is recognized as the 'high-water mark' for laboratory testing. I congratulate the entire team at Beckman Coulter Genomics. This accomplishment underscores our commitment to advancing healthcare for every person and reinforces our determination to deliver the highest standards of excellence," said Mr Tim Anderson, vice president and general manager of genomic services, Beckman Coulter. The accreditation strengthens the company's strong bioinformatics expertise and extensive experience in study design, guidance and analysis of customer's crucial clinical samples. "CAP accreditation signifies that our lab operates under rigorous quality standards to generate highly accurate and reliable data. We are pleased to be able to provide our customers a sequencing service which satisfies the exacting requirements of regulatory authorities and will help the facility more quickly move findings from clinical trials into clinical use," said Dr Stephen Lyle, laboratory director at Beckman Coulter Genomics.   ]]> https://biospectrumindia.com/news/97/4780/philips-to-collaborate-with-indica-labs.html https://biospectrumindia.com/news/97/4780/philips-to-collaborate-with-indica-labs.html Tue, 20 Jan 2015 12:03:26 +0530 Royal Philips has announced that it will further support efforts of oncology researchers to analyze pathology samples by offering advanced image analysis algorithms from Indica Labs, as part of its Digital Pathology Solutions offerings. The collaboration will allow pathology researchers to apply intelligent algorithms to digitized pathology slides, which may enhance their ability to detect, process and extract information from tissue samples than currently possible using a conventional microscope. "Digital pathology is the stepping stone to unlock the huge potential of data mining. More information from tissue samples could bring new insights in cancer care that support personal treatment, and ultimately will save patients' lives," said Mr Perry van Rijsingen, general manager of Philips Digital Pathology Solutions. By using the combined Philips Digital Pathology Solution and Indica's HALO image analysis platform, researchers will benefit from a streamlined image analysis workflow and improved productivity. Additionally, they will be able to extract more thorough information from tissue samples, enabling more insightful analysis than possible, all while generating those results in a matter of hours or even minutes versus days. According to Mr Steven Hashagen, CEO Indica Labs, "Digital pathology offers significant opportunity to arm scientists in oncology and pathology with the quantitative information they need in their research to improve the cancer care process. By incorporating the high-quality innovation of Philips' digital imaging and our precision HALO analysis platform, they have the tools to further investigate the predictive response of certain therapy with the ultimate goal to provide a personalized cancer treatment plan." Philips offers Indica's HALO as an option with its Digital Pathology Solution for Research Use Only.   ]]> https://biospectrumindia.com/news/97/4347/piramal-acquires-coldstream-lab-in-us.html https://biospectrumindia.com/news/97/4347/piramal-acquires-coldstream-lab-in-us.html Tue, 20 Jan 2015 11:52:46 +0530 India's pharmaceutical company, Piramal Enterprises, has acquired contract development and manufacturing organisation, Coldstream Laboratories, in the US at $30.65 million. Founded in 2007, Coldstream is engaged in the development and manufacturing of sterile injectable products and its majority is owned by the University of Kentucky Research Foundation (an affiliate of the University of Kentucky). Coldstream is a specialty pharmaceutical contract manufacturer with an emphasis on clinical trials for commercial-scale manufacturing of sterile liquid and lyophilized parenterals and injectables. The company has developed differentiated expertize to formulate and manufacture high potency and cytotoxic compounds including antibody drug conjugates (ADCs). The company operates from a FDA approved facility located in Lexington, Kentucky, USA. Commenting on the acquisition Mr Vivek Sharma, CEO, Piramal Enterprise-pharma solutions division said, "Coldstream is a very high quality operation and has been able to build significant customer relationships and track record for sterile products. We see this as a great platform for growth in our Pharma Solutions business. This acquisition allows PEL to move further into the injectable market segment and should have strong synergy with our existing Pharma Solutions business. Our strong capabilities in sterile product development and in ADC product segment will allow us to offer an integrated solution to our customers." Mr Bill Wedlake, president, Piramal Enterprises-pharma solutions formulations business added, "We have been impressed by the quality of the people at Coldstream and their success in both attracting high quality business and also their track record in quality. Coldstream's use of isolator technology is impressive and provides a foundation for expansion of the facility to provide large scale commercial manufacturing including production of highly potent compounds."   ]]> https://biospectrumindia.com/news/97/4164/agilent-ties-up-with-cell-signaling-technology.html https://biospectrumindia.com/news/97/4164/agilent-ties-up-with-cell-signaling-technology.html Tue, 20 Jan 2015 10:55:00 +0530 Dako Agilent Technologies and Cell Signaling Technology (CST) has announced that they have entered into a strategic partnership to supply antibodies for use in Dako-branded companion diagnostics products. Agilent Diagnostics and genomics president Mr Jacob Thaysen said, "We are pleased that collaboration with the CST, and development partner of high quality, advanced diagnostic reagents products, these products will be an important tool for cancer diagnosis and treatment." CST's chief executive, Mr Michael J Comb said, "CST recognizes that improving our methods of diagnosis and treatment of cancer patients, and companion diagnostic reagents products have great potential. We are confident that this partnership will allow our products to contribute to advances in personalized medicine." Financial details of the deal were not disclosed.   ]]> https://biospectrumindia.com/news/97/4494/philips-mit-collaborate-on-critical-care-patient-data.html https://biospectrumindia.com/news/97/4494/philips-mit-collaborate-on-critical-care-patient-data.html Mon, 19 Jan 2015 17:22:19 +0530 Philips will be granting access to data from more than 100,000 patients that have been collected and anonymized through the Philips Hospital to Home eICU telehealth program. The Laboratory of Computational Physiology within the MIT Institute for Medical Engineering and Science will serve as the academic research hub for the initiative, and will provide and maintain access, as well as help educate researchers on the database and offer a platform for collaboration. Most inpatient multi-center data sets available to researchers today are limited to insurance claims data, which offers just a summary of a patient's stay. Through this new initiative, Philips will release a more comprehensive look at the ICU patient's journey by opening up data sets from patient stays in eICU centers representing approximately 10 percent of all adult ICU beds in the United States. The secure database will include anonymized and detailed clinical data such as vital signs, pharmacy medication orders, laboratory results, diagnoses and severity of illness scores, giving researchers comprehensive insights into a patient stay.   "Researchers are always looking for better, more accurate and comprehensive data that enables a holistic representation of the patient experience," said Mr Leo Anthony Celi of MIT. "The quality and resolution of the data Philips has been collecting in the critical care domain is unprecedented. This kind of access will provide researchers with data that will enable investigations otherwise unimaginable."The data will be available to researchers via PhysioNet before the end of the year. PhysioNet offers free web access to large collections of physiologic signals and related open-source software. Investigators will be able to contribute to the expanding knowledge base by sharing their methodologies and findings with the larger research community to facilitate faster discoveries in the future. "We're proud to be leading the charge in the industry by opening up our data to independent researchers to allow them to conduct more meaningful analyses related to critical care medicine," said Mr Derek Smith, senior vice president, Hospital to Home, Philips Healthcare. "This initiative will make it easier for researchers to share methods and findings, bypassing the need to reinvent the wheel with each new research project. We hope this will lead to better, faster breakthroughs-and ultimately better medicine." The data set is compiled from records shared by hundreds of ICUs across the United States, and is managed by the Philips eICU Research Institute. This is one of the most extensive ICU-centric longitudinal data sets in existence and has been used by participants in the Philips eICU Research Institute to produce valuable peer-reviewed critical care research. ]]> https://biospectrumindia.com/news/97/5899/healthcare-it-vc-funding-doubles-up-in-2014.html https://biospectrumindia.com/news/97/5899/healthcare-it-vc-funding-doubles-up-in-2014.html Mon, 19 Jan 2015 12:12:00 +0530 The sector also brought in $2.1 billion in debt and public market financing including six IPOs, bringing the total corporate funding raised in the sector in 2014 to almost $7 billion. This was reported by the Mercom Capital Group, a global communications and consulting firm, which released its annual report on funding and mergers and acquisition (M&A) activity for the healthcare Information Technology (IT) sector in 2014. Mercom's comprehensive report covers deals of all sizes globally. "The Healthcare IT sector had another phenomenal fundraising year. In the five years since we started tracking funding data, the sector has raised $8.8 billion in VC funding and another $3.6 billion in public market and debt financings bringing the total to $12.4 billion - largely driven by the HITECH and Affordable Care Act. However, the enthusiasm in the sector shown by the VC community was not quite matched by the public markets when you look at market performance of companies that went the IPO route in 2014," commented Mr Raj Prabhu, CEO and co-founder of Mercom Capital Group. Practice-centric companies raised $2.4 billion in 234 deals in 2014, including Clinical Decision Support companies with $517 million, followed by Data Analytics companies with $367 million and Population Health Management companies with $247 million. Consumer-centric companies raised $2.3 billion in 436 deals. Mobile Health (mHealth) companies were the largest recipient of VC funding bringing in $1.2 billion - within mHealth most funding went to Wearables with $526M and mHealth Apps with $507M. Telehealth companies received $369 million, Rating and Comparison Shopping companies brought in $288 million. The top two VC funding rounds in 2014 were raised by NantHealth which brought in $320 million and $135 million in two separate deals; Flatiron Health raised $130 million; this was followed by Alignment Healthcare which raised $125 million. Proteus Digital Health came in next with its $120 million raise (they also raised $52 million in another deal bringing its total to $172 million for 2014); China's Guahao.com raised $100 million; Dedalus Group raised $89 million; and American Well brought in $81 million. A total of 732 investors were involved in funding rounds for Healthcare IT companies in 2014. The top VC investors were Khosla Ventures and The Social+Capital Partnership with nine deals each, followed by Kleiner Perkins Caufield & Byers and Sequoia Capital with seven deals each. Top investors in the sector from the past five years were Khosla Ventures with 21 deals, The Social+Capital Partnership with 18, Kleiner Perkins Caufield & Byers with 17, Sequoia Capital with 12 and Andreessen Horowitz with 10 deals. There were 120 accelerator and incubator deals in 2014 compared to 139 in 2013. Top accelerator/incubator seed investors were Blueprint Health, Rock Health, Y Combinator, DreamIt Ventures, Sprint Accelerator, The Iron Yard and XLerate Health. A record 29 countries participated in Healthcare IT VC funding activity this year. In the United States, California led Healthcare IT fundraising with 174 deals followed by New York with 50, Massachusetts with 33, Florida with 22, and Texas with 21. There were 219 M&A transactions in the Healthcare IT sector in 2014 compared to 165 transactions in 2013, with 21 companies making multiple transactions during the year. "Most of the M&A activity has been around larger, more established practice-focused companies. Even though Mobile Health related apps and wearables are getting significant funding, we have not seen a game-changing Instagram or WhatsApp-type transaction yet in the sector," continued Mr Prabhu. Revenue Cycle Management companies led M&A activity with 28 transactions followed by Practice Management with 24 and Mobile Health with 21. In the last five years, 121 companies have made multiple acquisitions including IMS Health with eight, CompuGroup Medical, Emdeon, iMedx and Quality Systems with seven each, and both McKesson and PracticeMax with six companies apiece. Cerner, GE Healthcare, Nuance Communications and The Advisory Board Company each acquired five companies. The Top 5 disclosed M&A transactions included the $4.4 billion acquisition of MultiPlan by Starr Investment Holdings and Partners Group, the acquisition of TriZetto by Cognizant for $2.7 billion, and the $1.3 billion acquisition of Siemens' health information technology business unit, Siemens Health Services, by Cerner. This was followed by Vista Equity Partners' acquisition of Advanced Computer Software for $1.14 billion, and the $550 million acquisition of ABILITY Network by Summit Partners. Chart: Mercom Top 5 Healthcare IT M&A Transactions in 2014 by Disclosed Amount There were six Healthcare IT IPOs in 2014, raising a total of $1.8 billion. IMS Health raised $1.3 billion, followed by Castlight Health with $204 million, Everyday Health with $100 million, Orion Health with $98 million, Imprivata with $86 million and Connecture with $53 million. ]]> https://biospectrumindia.com/news/97/4372/european-approval-for-coronary-stent-system-.html https://biospectrumindia.com/news/97/4372/european-approval-for-coronary-stent-system-.html Mon, 19 Jan 2015 11:50:21 +0530 Eurocor GmbH, a group company of Opto Circuits (India) has announced that the E-Magic Plus Sirolimus Eluting Coronary Stent System, has received CE (Conformité Européenne) Mark approval. E-Magic Plus is providing the latest technology in combining ultra-thin strut of a CoCr stent, with an optimal Sirolimus coating. Fully biodegradable polymer is minimizing delayed healing and late adverse events. Mr Vinod Ramnani, CMD of Opto Circuits said, "The CE mark approval of E-Magic Plus, represents a key milestone for Eurocor GmbH. We are now back in the largest cardiovascular product range, the DES. Thanks to its innovative technology, we'll be able to further expand treatment options for patients with introduction of E-Magic Plus - highly differentiated DES with Sirolimus Coating and biodegradable polymer." E-Magic Plus received registration approval in India last year and has been available for sale for few months already.  With this approval, Eurocor GmbH is preparing to make the E-Magic Plus commercially available in Europe and other markets where CE Mark approval can expedite the registration process.       ]]> https://biospectrumindia.com/news/97/6009/a-tattoo-to-detect-glucose-levels.html https://biospectrumindia.com/news/97/6009/a-tattoo-to-detect-glucose-levels.html Sat, 17 Jan 2015 09:47:00 +0530 Researchers at the University of California, San Diego the first ultra-thin, flexible device that sticks to skin like a rub-on tattoo and can detect a person's glucose levels. The sensor has the potential to eliminate finger-pricking for people with diabetes. Mr Joseph Wang and colleagues wanted to find a better approach to develop glucose monitoring device. They made a wearable, non-irritating platform that can detect glucose in the fluid just under the skin based on integrating glucose extraction and electrochemical biosensing. Preliminary testing on seven healthy volunteers showed it was able to accurately determine glucose levels. The researchers conclude that the device could potentially be used for diabetes management and for other conditions such as kidney disease. The proof-of-concept study is published in the ACS journal Analytical Chemistry.   ]]> https://biospectrumindia.com/news/97/1296/philips-collaborate-with-mit-on-icu-data-sharing.html https://biospectrumindia.com/news/97/1296/philips-collaborate-with-mit-on-icu-data-sharing.html Fri, 16 Jan 2015 12:51:00 +0530 Royal Philips has announced a new initiative with Massachusetts Institute of Technology (MIT) to allow health care researchers to tap into one of the largest data sources available for research into critical care. Philips will be granting access to data from more than 100,000 patients that have been collected and anonymised through the Philips Hospital to Home eICU telehealth program. The Laboratory of Computational Physiology within the MIT Institute for Medical Engineering and Science will serve as the academic research hub for the initiative, and will provide and maintain access, as well as help educate researchers on the database and offer a platform for collaboration. Through this new initiative, Philips will release a more comprehensive look at the ICU patient's journey by opening up data sets from patient stays in eICU centers representing approximately 10 percent of all adult ICU beds in the United States. The secure database will include anonymised and detailed clinical data such as vital signs, pharmacy medication orders, laboratory results, diagnoses and severity of illness scores, giving researchers comprehensive insights into a patient stay. "Researchers are always looking for better, more accurate and comprehensive data that enables a holistic representation of the patient experience. The quality and resolution of the data Philips has been collecting in the critical care domain is unprecedented. This kind of access will provide researchers with data that will enable investigations otherwise unimaginable," said Mr Leo Anthony Celi of MIT. The data will be available to researchers via PhysioNet before the end of the year. "We are proud to be leading the charge in the industry by opening up our data to independent researchers to allow them to conduct more meaningful analyses related to critical care medicine. This initiative will make it easier for researchers to share methods and findings, bypassing the need to reinvent the wheel with each new research project. We hope this will lead to better, faster breakthroughs-and ultimately better medicine," said Mr Derek Smith, senior vice president, Hospital to Home, Philips Healthcare.   The data set is compiled from records shared by hundreds of ICUs across the US, and is managed by the Philips eICU Research Institute.   ]]> https://biospectrumindia.com/news/97/4246/medical-devices-industry-ma-all-time-high-in-2014.html https://biospectrumindia.com/news/97/4246/medical-devices-industry-ma-all-time-high-in-2014.html Thu, 15 Jan 2015 11:12:00 +0530 Ms Niharika Midha, GlobalData's analyst covering medical devices, states that the unusually high amount of M&A activity last year highlights a trend that goes beyond mega-mergers and into the expansion of product portfolios. She says: "A considerable number of deals in 2014 involved larger companies swallowing up smaller ones with novel technologies that were clinically proven to be superior to existing devices. "This definitely sets the tone for the coming year, as the medical device industry consolidates into fewer prominent players that directly compete with each other and innovation is fueled by heightened demand." The largest deal of 2014 was Medtronic's $42.9 billion acquisition of Covidien, creating the world's largest medical device company. Despite criticism that the move was rooted in tax inversion, GlobalData's analyst believes there were a number of strategic motives behind the deal.   Ms Midha explains, "Covidien has an established market position in surgical and wound care specialties, which are promising segments. Medtronic can now readily leverage this reputation for an expanded product portfolio and enhanced global footprint. Additionally, Covidien has been expanding its business in patient monitoring and hospital services, areas likely to generate significant revenue in the near future." The analyst adds that players with an extensive product portfolio tend to have a competitive advantage in the current industry scenario. "The demand side is displaying an increasing preference for manufacturers that offer a one-stop solution for all their needs," Ms Midha concludes. ]]> https://biospectrumindia.com/news/97/6500/transasia-launches-new-instruments-for-coagulation.html https://biospectrumindia.com/news/97/6500/transasia-launches-new-instruments-for-coagulation.html Wed, 14 Jan 2015 13:12:35 +0530 Transasia Bio-Medicals has announced the launch of two advanced coagulation analyzers, ECL 105 - Single Channel and ECL 412 - Four Channel. The company claims that both these analyzers provides most accurate/precise results. Both the instruments include operate LCD touch screen graphical display, built-in incubator for cuvette- facility for reagent incubation through magnetic stirring, in-built robust thermal printer, easy connectivity through USB ports, ethernet ports and RFID detection facility, storage of data and coagulation clotting curves is possible on an external drive. Also its software is Intuitive, with minimal simple logical inputs in programming tests, multi-standard calibration, plotting multilevel QC points and running tests and proven technology of coagulation curve in percentage light scatter for clot detection. The ERBA ECL 105/ 412 performs the most comprehensive coagulation tests in semi-automated systems. The tests such as Fibrinogen, Factors assays, Lupus anticoagulant, Protein C , Protein S, AT III and D Dimer are programmed and can be performed with minimum effort.   ]]> https://biospectrumindia.com/news/97/4904/covidiens-new-device-receives-ce-mark-.html https://biospectrumindia.com/news/97/4904/covidiens-new-device-receives-ce-mark-.html Mon, 12 Jan 2015 13:17:32 +0530 Covidien has announced that it has received CE Mark approval for its Stellarex drug-coated angioplasty balloon (DCB). The Stellarex DCB is used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease (PAD). The Stellarex DCB's proprietary EnduraCoat technology provides a durable, uniform coating which reduces drug loss during transit and facilitates efficient drug delivery to the treatment site. The 24 month results of the ILLUMENATE First-in-Human (FIH) study demonstrated a primary patency rate (ability to keep the artery open to restore blood flow) of 80.3 percent. Additionally, the study showed 87.9 percent freedom from target lesion revascularization at 12 months and 85.8 percent at 24 months. "PAD is a progressive disease that affects millions of people around the world. DCBs are emerging as an alternative to traditional treatment options, such as angioplasty or stenting, because of their ability to restore blood flow, prevent the reoccurrence of new blockages and preserve future treatment options. In clinical trials, the Stellarex DCB has demonstrated promising results with strong patency rates and low reoccurrence of target lesions at 24 months," said Dr Henrik Schröeder, radiologist, Vascular Center-Jewish Hospital, Berlin, and principal investigator, ILLUMENATE FIH Study.     ]]> https://biospectrumindia.com/news/97/4796/wireless-portable-medical-device-market-to-be-worth-2-83-billion-by-2020.html https://biospectrumindia.com/news/97/4796/wireless-portable-medical-device-market-to-be-worth-2-83-billion-by-2020.html Mon, 12 Jan 2015 10:14:00 +0530 According to a new report titled "Wireless Portable Medical Device Market by Technology (BT/BLE, Wi-Fi, ZigBee, ANT+), Component (Sensors, ICs, Processors), Application (Monitoring, Medical Therapeutics, Diagnosis, Fitness and Wellness), and Geography - Global Forecast to 2020", published by MarketsandMarkets, the total Wireless Portable Medical Device Market is expected to grow from $1.5 Billion in 2013 to $2.83 Billion in 2020, growing at an estimated CAGR of 9.51 percent from 2014 to 2020. With a gradual increase in urbanization and healthcare facilities, the need for wireless portable medical devices is also expected to grow proportionately to be able to support this growth. Developing countries such as India and China are fueling the growth of the medical sector; hence, the wireless portable medical devices market is boosting the overall healthcare sector. The Wireless Portable Medical Device Market is expected to benefit from emerging market investments that are lifting the standards of healthcare, while the developed market is expected to continue investing in more efficient medical electronic devices, systems and procedures, which offer better and personalised healthcare. An increase in lifestyle diseases continuously pushes patients for medical monitoring to get their health status to avoid any health related contingencies; medical devices such as cardiac monitors and hemodynamic monitors are continuously gaining market share in the wireless portable medical device applications. The market size for the Wireless Portable Medical Device Market covers four geographic splits, namely North America, Europe, Asia-Pacific, and Rest of the World (RoW).   ]]> https://biospectrumindia.com/news/97/4403/acacia-subsidiary-solves-dispute-with-carl-zeiss.html https://biospectrumindia.com/news/97/4403/acacia-subsidiary-solves-dispute-with-carl-zeiss.html Sun, 11 Jan 2015 11:02:00 +0530 Acacia Research Corporation has announced that its Super Resolution Technologies subsidiary and Carl Zeiss Microscopy, and Carl Zeiss Microscopy, GmbH have reached a resolution of their dispute over the Fluorescent Nanoscopy patents. The agreement resolves litigation that was pending in the United States District Court for the Southern District of Texas.   ]]> https://biospectrumindia.com/news/97/4634/biolife-solutions-products-used-in-175-clinical-trials.html https://biospectrumindia.com/news/97/4634/biolife-solutions-products-used-in-175-clinical-trials.html Sun, 11 Jan 2015 10:25:00 +0530 BioLife Solutions has provided an update on the adoption of its HypoThermosol and CryoStor biopreservation media products in a greatly increased number of customer clinical trials of novel cellular immunotherapies and other cell-based approaches for treating and possibly curing the leading causes of death and disorders throughout the world. In January 2014, the management estimated that BioLife products were incorporated into the storage, shipping, freezing, and/or clinical administration processes and protocols of 100 regenerative medicine clinical trials. For the calendar year 2014, management estimates that an additional 75 regenerative medicine clinical trials using its products were confirmed, bringing the total to 175. Confirming and supporting information is sourced from customer requests to cross reference BioLife's US FDA Master Files for CryoStor and HypoThermosol in clinical trial applications, other customer and distributor communications, and the www.clinicaltrials.gov website. Within the cellular immunotherapy segment of the regenerative medicine market, BioLife's products are embedded in the manufacturing, storage, and delivery processes of at least 75 clinical trials of chimeric antigen receptor T cells (CAR-T), T cell receptor (TCR), dendritic cell (DC), tumor infiltrating lymphocytes (TIL), and other T cell-based cellular therapeutics targeting solid tumors, hematologic malignancies, and other diseases and disorders. A large majority of the currently active private and publicly traded cellular immunotherapy companies are BioLife customers. Mr Mike Rice, president and CEO, BioLife said, "2014 was a pivotal year for BioLife, with expanded product adoption by several very promising high profile and well-funded regenerative medicine companies. Nearly half of the clinical trials sponsored by our customers using our biopreservation media products to store, freeze, ship, and administer cells to patients involve some type of T cell based immunotherapy." He continued, "We are very well positioned to participate in the growth of the regenerative medicine market and the truly remarkable cellular immunotherapy segment of oncology care. BioLife is a classic embedded technology story, with our biopreservation media products part of our customer processes, and also with our new biologistex cold chain management service, which can improve logistics and monitoring shipments of high-value manufactured cell products. We have worked very hard to build this marquee customer base in what could emerge as one of the largest growth opportunities in the history of medical innovation and market development."   ]]> https://biospectrumindia.com/news/97/4635/an-elisa-detection-assay-for-ebola.html https://biospectrumindia.com/news/97/4635/an-elisa-detection-assay-for-ebola.html Sun, 11 Jan 2015 10:24:00 +0530 AMSBIO has announced several products suitable for the development of an ELISA detection assay for the Ebola virus. The new products comprise three different monoclonal antibodies to the Ebola virus and two recombinant proteins (from the Sudan and Zaire strains) suitable for use in producing an optimised ELISA test kit for Ebola. An antigen-capture enzyme-linked immunosorbant assay (ELISA) test for Ebola offers the possibility of diagnosis within the first few days after symptoms begin.  It is caused by four different Ebola species in humans: Bundibugyo evolavirus, Sudan ebolavirus, Taï Forest ebolavirus and Zaire ebolavirus, which is the most dangerous. Diagnosing Ebola can be a challenge because the early symptoms are nonspecific to Ebola infection and are often seen in patients with more commonly occurring diseases, such as malaria and typhoid fever. Accurate diagnostics are essential in controlling an outbreak.   ]]> https://biospectrumindia.com/news/97/4637/masimo-india-introduces-low-cost-pulse-oximetry.html https://biospectrumindia.com/news/97/4637/masimo-india-introduces-low-cost-pulse-oximetry.html Sun, 11 Jan 2015 09:56:00 +0530 Pulse oximetry is widely used and has gained critical importance in clinical care. Masimo has further revolutionised the world of pulse oximetry with its signal extraction technology (SET), estimated to be used on more than 100 million patients a year in leading hospitals worldwide. Masimo SET Measure-through Motion and Low Perfusion pulse oximetry is shown to virtually eliminate false alarms and help clinicians detect life-threatening events. Sat 901+ is designed for handheld and bedside monitoring, including acute care and alternate care settings such as long-term care facilities, homecare and sleep labs. Medical device industry is innovating to design India-specific products to effectively cater to the unique needs of this market. Sat901+ has been designed to operate in a multitude of environments with extensive focus on portability and ease of use, both in urban and rural settings.   "Masimo is committed to do what is best for patient care and believes that products like Sat901+ can help penetrate the rural healthcare market in India and bring patients in those areas the same advanced technologies that those in the cities benefit from. It is our goal to make technologies affordable and accessible," said Mr Bharat Monteiro, country manager, India and the Subcontinent, Masimo Medical Technologies India. This low-cost pulse-oximeter houses the same quality and patented SET technology that allows clinicians to measure through motion and low perfusion. With the introduction of this new product, Masimo is well-positioned for the highly price-competitive market in India. ]]> https://biospectrumindia.com/news/97/4572/agilent-upgrades-its-genomic-dna-screentape-assay.html https://biospectrumindia.com/news/97/4572/agilent-upgrades-its-genomic-dna-screentape-assay.html Sat, 10 Jan 2015 10:23:00 +0530 Agilent Technologies has announced the addition of an important new feature to its Genomic DNA ScreenTape assay-the DNA Integrity Number, or DIN, for assessing the integrity of genomic DNA. The new feature is designed to ensure the quality of genomics experiments, especially next-generation sequencing (NGS). It builds on the company's technology for assessing the integrity of RNA-the RNA Integrity Number, or RIN. With the new software feature, the Agilent Genomic DNA ScreenTape assay can now provide an objective measure of DNA integrity for a wide range of samples-not just intact samples from fresh tissue but even the highly degraded samples often obtained from formalin-fixed, paraffin-embedded tissues. The ability to accurately assess the quality of DNA samples is becoming more important as researchers engage in ever-larger NGS studies. DIN could also prove invaluable at large repositories of tissues, known as biobanks, as a tool for measuring archival quality. The DIN is expected to play a key role in determining the quality of samples as they enter the NGS workflow. It will help researchers better define their genomic DNA samples, standardize their integrity assessment and potentially streamline their sequencing workflow.   Agilent is making DIN freely available as a software upgrade.   ]]> https://biospectrumindia.com/news/97/4348/medgenome-join-hands-with-us-based-natera.html https://biospectrumindia.com/news/97/4348/medgenome-join-hands-with-us-based-natera.html Fri, 09 Jan 2015 09:34:00 +0530 MedGenome and Natera have entered into an exclusive agreement to bring non-invasive prenatal testing (NIPT) to India. As part of the agreement, MedGenome will have exclusive license to develop the capacity and perform the Panorama test in the country. Natera's test, known as Panorama, is a non-invasive prenatal screening test that examines fetal DNA in the mother's blood to assess whether a developing baby is at high risk for having an abnormality in the chromosomes. The company also stated that in accordance with Indian law, Panorama will not be used to reveal the sex of the fetus. "As per estimates, chromosomal abnormalities occur in about 1 of 200 live births. Infants with these abnormalities have mental retardation and suffer from malformations and disabilities. Due to the large number of births which is estimated at 26 million per year, India has the largest number of babies born with chromosomal disorders in the world accounting for almost 130,000 per year. Our partnership with Natera will help us provide Panorama, a superior second-generation non-invasive prenatal test, compared to its peers. Through our partnership with Natera, we hope to bring about significant changes in the way pregnancies are managed in India," said Mr Sam Santhosh, CEO, MedGenome. "We are committed to sharing its unique and proprietary technologies with laboratories worldwide who share our philosophy of clinical leadership and quality control," said Mr Solomon Moshkevich, vice president, marketing and business development, Natera.   ]]> https://biospectrumindia.com/news/97/4335/philips-healthcare-device-receives-fda-clearance.html https://biospectrumindia.com/news/97/4335/philips-healthcare-device-receives-fda-clearance.html Fri, 09 Jan 2015 09:05:00 +0530 Royal Philips has announced that it has received 510(k) clearance from the US Food and Drug Administration (US FDA) to market its Avalon CL Fetal Monitoring solution (Avalon CL). The solution provides consistent monitoring of the mother and child, without the burden of managing cables, allowing mothers more freedom of movement during labor. The product joins the company's existing portfolio of mobility solutions designed for advanced monitoring and connected care across the health continuum, from healthy living and prevention, to diagnosis, treatment, recovery and home care. "Conventional fetal monitoring solutions present limitations for physicians and patients alike. This latest cableless technology enhances clinician confidence and allows women more flexibility and freedom of movement during labor, which can be very beneficial to the woman and child," said Mr Mike Mancuso, CEO of Philips Healthcare's Patient Care and Monitoring Solutions.   ]]> https://biospectrumindia.com/news/97/5667/sartorius-to-sell-its-industrial-technologies-division-in-q1-2015.html https://biospectrumindia.com/news/97/5667/sartorius-to-sell-its-industrial-technologies-division-in-q1-2015.html Thu, 08 Jan 2015 09:41:00 +0530 The respective contract was signed by both parties. The sales price will be determined as a multiple of the Intec division's 2014 operating profit and be fixed in early 2015. The contractual parties agreed on a 7.5 multiple on the division's 2014 operating EBITDA. The transaction is subject to customary closing conditions, including regulatory clearance by the antitrust authorities, and is expected to close in the first quarter of 2015. "By selling our Intec division to Minebea, we are realizing an important cornerstone of our long-term strategy and focus on our two core activities in Bioprocess and Laboratory....," commented Mr Joachim Kreuzburg, CEO and chairman of the executive board of Sartorius.   The smallest division in the Sartorius Group, Intec, recorded sales revenue of 102 million euros for fiscal 2013; its underlying EBITDA margin attained 10.1 percent at year-end in the prior reporting period. The division employs around 700 people worldwide, 350 of whom work at its German sites in Hamburg, Aachen and Bovenden. The Intec business will complement the measurement components business unit at Minebea, which will take on all Intec division staff. ]]> https://biospectrumindia.com/news/97/4102/phenomenex-adds-advanced-columns-to-its-kinetex-line.html https://biospectrumindia.com/news/97/4102/phenomenex-adds-advanced-columns-to-its-kinetex-line.html Wed, 07 Jan 2015 10:07:00 +0530 Singapore: Phenomenex, a global leader in the separation sciences has added an advanced product to its Kinetex line. Called the Kinetex F5, the columns are said to contain a robust pentafluorophenyl propyl (PFP) core-shell phase that overcomes reproducibility and performance limitations of existing PFP and F5 products on the market. They are an ideal solution HPLC/UHPLC development work with its combination of polar and non-polar interactions including hydrogen bonding, electrostatic, hydrophobic, aromatic and steric/planar mechanisms. Kinetex F5 is available in 2.6 and 1.7 µm particle sizes. "Our company truly values the customers' voice and working beyond the status quo," explained Simon Lomas, brand manager for Phenomenex. "These new Kinetex F5 columns are the result of years of research, development and customer input. With better, more accurate and higher performance products like the Kinetex core-shell F5, scientists can continue to push the current limits of separation science. ]]> https://biospectrumindia.com/news/97/4426/siemens-unveils-its-new-wearable-device.html https://biospectrumindia.com/news/97/4426/siemens-unveils-its-new-wearable-device.html Tue, 06 Jan 2015 15:18:04 +0530 At the 2015 International CES, Siemens is unveiling smart hearing aids, their latest in wearable hearing technology. The hearing aids can be discreetly controlled via both iPhone and Android devices, with latest models clinically proven to outperform people with normal hearing in background noise. When two hearing aids are worn (the most common case), the new smart hearing aids utilise intelligent, two-way wireless communication to zero in on desired speech with pinpoint accuracy. This enables better-than-normal hearing in crowded situations like noisy restaurants and cocktail parties where background chatter has historically been a challenge. "These are not your average hearing aids but rather highly-intelligent wearable devices. They automatically detect everyday listening environments such as a noisy room, wind, or while driving a car, and instinctively know what to do," said Mr Scott Davis, CEO, Siemens Hearing Instruments. When paired with Siemens' new easyTek and easyTek App, a wearer can control the direction of the hearing aids' microphones-front, left, right, or behind-to simultaneously enhance speech and suppress background noise. The span of the microphones' focus can also be controlled via the app, allowing wearers to select a wide range of focus or a very narrow beam. "Some hearing aid wearers also want the flexibility that comes with having control over their listening experience. We have all heard of and can appreciate the benefits of on-demand TV. With these hearing aids, you can turn your iPhone or Android device into a hearing aid control center. We call it on-demand hearing," added Mr Davis. While Siemens' new smart hearing aids pair with virtually any iOS or Android mobile device for a custom-tailored listening experience, a smartphone is not required to make use of the new technology. The hearing aids continuously scan the acoustic environment and activate the most optimal settings for that particular listening situation.   ]]> https://biospectrumindia.com/news/97/3963/100-percent-fdi-to-increase-investment-.html https://biospectrumindia.com/news/97/3963/100-percent-fdi-to-increase-investment-.html Mon, 05 Jan 2015 13:13:14 +0530 American Chamber of Commerce (AMCHAM) in India has said that 100 percent foreign direct investment (FDI) in the medical devices sector will attract US firms to invest and manufacture in India. The Government had last month allowed 100 percent FDI under automatic route both in greenfield and brownfield projects in the medical devices sector. "The move by the central government to amend 100 percent FDI in medical devices will encourage FDI inflows into the sector and will also attract the US companies to invest and manufacture in India," said Mr Ajay Singha, AMCHAM India executive director in a statement.       ]]> https://biospectrumindia.com/news/97/3959/siemens-healthcare-to-expand-in-india.html https://biospectrumindia.com/news/97/3959/siemens-healthcare-to-expand-in-india.html Mon, 05 Jan 2015 13:12:42 +0530 Siemens Healthcare has said that though it does not plan to open a new facility in India but it would expand its existing manufacturing base here to supply clinical products to other countries. "We want to increase the breadth and depth of our local manufacturing portfolio primarily with 'local-for-local concept' as India is a very significant market. Eventually we aim to manufacture in India for global consumption as well," said Ms Britta Fuenfstueck, Siemens Healthcare CEO for clinical products division in a statement. she further said the company wants to introduce more India-relevant products from the global basket like digital radiography.     ]]> https://biospectrumindia.com/news/97/4230/scientists-develop-a-new-3d-culture-system-for-pancreatic-cancer.html https://biospectrumindia.com/news/97/4230/scientists-develop-a-new-3d-culture-system-for-pancreatic-cancer.html Fri, 02 Jan 2015 13:55:40 +0530 Researchers at the Cold Spring Harbor Laboratory (CSHL) and The Lustgarten Foundation has developed a new model system to grow both normal and cancerous pancreatic cells in the laboratory. The team describes this new systema as a three-dimensional "organoid" culture system. Through this method, pancreatic tissue can be grown not only from laboratory mouse models, but also from human patient tissue, offering a path to personalized treatment approaches in the future. The research was co-led by Mr David Tuveson, CSHL professor and director of research for The Lustgarten Foundation, and Mr Hans Clevers, professor and director of the Hubrecht Institute and president of the Royal Netherlands Academy of Arts and Sciences. "With this development, we are now able to culture both mouse and human organoids, providing a very powerful tool in our fight against pancreatic cancer," said Mr Tuveson. The organoids are entirely made up of ductal cells, eliminating the surrounding cell types that often contaminate samples from the pancreas. They grow as hollow spheres within a complex gel-like substance filled with growth-inducing factors and connecting fibers. Once they have grown to a sufficient size, the organoids can be transplanted back into mice, where they fully recapitulate pancreatic cancer. The team is now working to create a repository of pancreatic tumor samples, coordinating with the National Cancer Institute. "We hope to make this available to the entire pancreatic cancer research community," said Mr Tuveson.   ]]> https://biospectrumindia.com/news/97/1503/bioasia-collaborate-with-ima-and-tie-.html https://biospectrumindia.com/news/97/1503/bioasia-collaborate-with-ima-and-tie-.html Thu, 01 Jan 2015 14:52:21 +0530 BioAsia 2015 has partnered with Indian Medical Association (IMA) and TiE (The Indus Entrepreneurs) for expanding digital healthcare in India. As per the partnership TiE and IMA will help BioAsia to design the content and interactive modalities, to spread the potential of this opportunity to its member base, engage with the start up community and doctors to participate in the initiative. "Information technology and digital healthcare holds high promise in enabling solutions for improving human health. On one hand the usage of mobile phone is increasing rapidly and on the other doctors has increasingly started using mHealth apps to engage with patients as well as in their daily practices. IMA and TiE are uniquely placed to partner BioAsia in helping meet this objective," said Mr Shakthi Nagappan, CEO of BioAsia. BioAsia conference is expected to discuss on challenges of Indian Healthcare delivery environment and inadequate infrastructure. Role of IT and mobile technologies such as virtual reality, cyber surgery, micro-robotic surgery and 3D modelling along with role of big data analytics and Indian Space Research Organisations will also be discussed at the IT healthcare conclave. "By partnering with BioAsia 2015 we are offering another platform for our startup ecosystem to explore the possibilities in the healthcare domain. One of focus areas in the track is data analytics where the startup community can contribute significantly," said Mr Murali Bukkapatnam, president, TiE Hyderabad.   ]]> https://biospectrumindia.com/news/97/3449/scientists-develop-a-new-method-to-detect-alzhiemers-early.html https://biospectrumindia.com/news/97/3449/scientists-develop-a-new-method-to-detect-alzhiemers-early.html Tue, 30 Dec 2014 13:25:50 +0530 A team of Scientists led by Dr William L Klein and Dr Vinayak P Dravid at the Northwestern University have developed a non-invasive MRI approach that can detect Alzheimer's disease in a living animal before its typical symptoms appear. They have developed an MRI (magnetic resonance imaging) probe that pairs a magnetic nanostructure (MNS) with an antibody that seeks out the amyloid beta brain toxins responsible for onset of the disease. The accumulated toxins, because of the associated magnetic nanostructures, show up as dark areas in MRI scans of the brain. "We have a new brain imaging method that can detect the toxin that leads to Alzheimer's disease," said Dr Klein. He added, "Using MRI, we can see the toxins attached to neurons in the brain," Klein said. "We expect to use this tool to detect this disease early and to help identify drugs that can effectively eliminate the toxin and improve health." This new MRI probe technology is detecting something different from conventional technology: toxic amyloid beta oligomers instead of plaques, which occur at a stage of Alzheimer's when therapeutic intervention would be very late. Amyloid beta oligomers now are widely believed to be the culprit in the onset of Alzheimer's disease and subsequent memory loss.   ]]> https://biospectrumindia.com/news/97/5687/philips-to-acquire-volcano-corp.html https://biospectrumindia.com/news/97/5687/philips-to-acquire-volcano-corp.html Mon, 29 Dec 2014 12:45:00 +0530 Royal Philips and Volcano Corporation has announced that they have entered into a definitive merger agreement. As per the agreement, Philips will commence a tender offer to acquire all of the issued and outstanding shares of Volcano for $18.00 per share, or a total equity purchase price of $1 billion to be paid in cash upon completion. The board of directors of Volcano has unanimously approved the transaction and recommends the offer to its shareholders. With 2013 sales of approximately $400 million,California-based Volcano is a catheter-based imaging and measurements for minimally invasive diagnostics and treatment of coronary artery disease and peripheral vascular disease company. "The agreement to acquire Volcano significantly advances our strategy to become the leading systems integrator in image-guided therapies," said Mr Frans van Houten, CEO, Royal Philips. He added, "Volcano's impressive and unique product portfolio is highly complementary to our strong offering in live image-guidance solutions, creating an opportunity to accelerate the revenue growth for our image-guided therapy business to a high single-digit rate by 2017. Our combined sales forces will be able to capture immediate cross selling opportunities, while our joint R&D teams will be able to develop new solutions to address significant unmet needs in the minimally invasive treatment of cardiovascular diseases." "I am very excited that Volcano will become part of Philips and join forces with its leading image guided therapy business. This transaction will be beneficial for our shareholders, customers, partners and employees. There is a large and growing global market opportunity for image-guided therapies, and as part of Philips, we gain the scale and resources needed to accelerate our goals of improving patient outcomes on a global basis, lowering cost and delivering innovative diagnostics and therapies in the coronary and peripheral markets. In addition, our shared expertise in the image-guided therapy market will allow us to further globalize our leading IVUS and FFR product offerings and enter new product areas. We look forward to working closely with Philips and ensuring a smooth transition and closing," said Mr Scott Huennekens, Volcano president and CEO. Upon completion of the transaction, the Volcano business and its 1,800 employees will be part of a dedicated, new image-guided therapy business group within Philips, which will be led by Philips executive Mr Bert van Meurs. The transaction is expected to close in the first quarter of 2015.   ]]> https://biospectrumindia.com/features/97/5611/pharma-biotech-cos-low-on-vc-radars.html https://biospectrumindia.com/features/97/5611/pharma-biotech-cos-low-on-vc-radars.html Sat, 27 Dec 2014 09:26:00 +0530 This is primarily driven by increasing per capita disposable income, rising urbanization and growing health awareness, rapidly shifting disease patterns from acute to chronic, and growth in domestic healthcare infrastructure. In the last two years, the healthcare and Life Sciences sectors have attracted over $2.3 billion worth of private equity (PE) investments, accounting for over 10 percent share of all PE investments done in India. The Indian healthcare and lifesciences sector continues to be among the top five destinations for private equity investors in India. Are VCs risk averse? "In my view, within the Life Sciences space, VCs are highly risk averse to novel drug discovery investments given the very high failure rates involved. Aside of this, most other segments in lifesciences including generics, contract manufacturing, IT, discovery services, and retail, have all faced active investments by VCs," opined Ms Visalakshi Chandramouli, Partner - Healthcare Fund (Private Equity), Tata Capital.   There are also others who are willing to take calculated risks in an investment. "Good venture capitalists in lifesciences and in other areas are those who take thoughtful risks, but 'taking risk' alone is not a wise investment strategy. I agree that India doesn't have a well-developed ecosystem. This is partly a developmental issue. As we see companies delivering sound returns, there will be greater appetite for life sciences opportunities among venture firms," Mr Rajeev Mantri, executive director, Navam Capital, said optimistically. At times, it may totally depend on who the VCs are, what their mandate or philosophy is. Mr Vishal Gandhi, founder & CEO, BioRx Venture Advisors (BVA), commented, "It is important to find the right advisor so that the chances of raising the capital is more. One needs to appreciate the role of advisors and they are not risk averse. There are no businesses without risks provided there are appropriate mitigation strategies." There are other seed investment firms in India that have appetite to invest in early stage enterprises. "VCs generally enter after establishing proof-of-concept. We like to place riskier bets and understand the need of the hour for enterprises that are just starting out," emphasized Mr Sanjib Jha, CEO, IntelleGrow. Attracting VCs   For start-ups to attract VC investments, it is imperative they clarify their abilities and timeline for achievement of proof-of-concept, and as well as the concept's scalability potential. According to Ms Padmaja Ruparel, president, Indian Angel Network, "It is vital to focus on building a venture because you want to do it. It should be a passion as that will make it a well differentiated, fast-growing company and you will ensure you execute and deliver well. If you do this, investors will come flocking!" Also, start-ups should build outstanding teams that can win investors' confidence. Mr Sanjib states that it is crucial to have a clear, five-year strategic model plan. "Put in a good team in place and invest in understanding your own abilities to deliver each year. Keep incorporating changes, given learning, even if it means going back to the whiteboard and starting from the scratch. If you stay honest to your model and plans, the VCs will be aligned," he advised. The Tata Capital Healthcare Fund (TCHF) targets long-term capital appreciation through PE growth-capital investments in healthcare companies that have a significant proportion of their operations in, or revenues from India. Mr Vishal advises start-ups to do their homework well and understand what VCs are looking for. "VCs are there to support them financially and they need to be highly proactive in searching the right VCs because not everyone is willing to invest their money. Most of the time VCs do their due diligence in investing in start-ups. This diligence should be among entrepreneurs as well before they reach out to VCs. That's where professional advisors bridge the gap," he commented.   Factors driving investments Mr Sanjib points that investors' assessment model lays a lot of stress on entrepreneurs, their ability to deliver and operationalize great ideas. "Along with this, we test for the viability and scalability of business models by going deeper than available financial statements and understanding projected cash flows," he mentioned. Ms Padmaja lays emphasis on factors like fast growing market. "Well differentiated proposition, a promoter team which understands the challenges in the space and has a focus on execution are critical," she listed. "The three most important factors are team, technology and market opportunity," said Mr Rajeev. He believes that a world-class team, with novel and differentiated technology pursuing a large market makes for a winning combination.   "Financial investors are motivated by the prospect of capital appreciation. Healthcare and Life Sciences are promising and such prospects are high. So investors are keener than ever to look at this sector," he said. A 2010 study by the Confederation of Indian Industry (CII) found that India needs $50 billion annually for the next 20 years in order to meet World Health Organization (WHO) standards. "A further injection of $82 billion is required to close the current healthcare infrastructure deficit. The sheer demand for capital along with capable entrepreneurs and new business models are key drivers," explained Mr Sanjib. Another aspect driving investments in this space is the outlook of downstream investors. With foreign private equity players looking closely in this space in India, investors are also considering areas that would look attractive to follow on investments and exits from these downstream investors. "Weightage given to an entrepreneurial team that has delivered success in the past can be higher than others. The other interesting aspect is that innovative technology per se does not appear to drive the investment decision, but needs to be coupled with a well thought-through business model at the time of investment," Mr Ashwin opined. Ms Padmaja noted an interesting trend where she points that teams with medical background are going entrepreneurial. "The entrepreneurship bug has gone viral in India! Thus teams with complimentary skillsets, high quality domain expertise, passion and focus on execution are starting out," she revealed.   Investment dilemmas Regulatory uncertainty is viewed as a key challenge by many investors. "The government needs to address this immediately," urged Mr Rajeev. Mr Ashwin, on a similar line noted, "The biggest challenge today in the Life Science sector is the uncertain regulatory atmosphere related to clinical trials, and the larger problem of global acceptance of results from trials conducted in India." Initiatives like Stanford Biodesign is helping breed medical entrepreneurs. However, innovators of healthcare products are not very common in India. "Building products need higher amounts of investment as well as longer gestation time. Unlike most of the developed economies which breed innovators in building products, India does not yet have an enabling ecosystem such as grants, high-quality and well equipped research labs, and enabling IP rules among others. All of these become detrimental and make the innovator's journey arduous," said Ms Padmaja.   What's trending? Mr Vishal points that in terms of investments in the Life Sciences, the momentum has been sluggish in the last couple of years. "One challenge is that the IPO market is not very vibrant. The valuation expectations of promoters are very high, and that is a deterrent. Thus, the overall ecosystem for this year in terms of investments was not very good," he remarked. However, there has been an increasing interest over the last 2-3 years in the diagnostics, drug discovery and equipments space. "The increasing number of entrepreneurs and new business models have attracted VC investors in this area. The next few years are interesting in terms of watching the investment patterns and expectations from VCs along with the performance of different business models," predicted Mr Sanjib. Experts opine that providers of healthcare at optimum cost is a big market opportunity and a growing one.   "This is the opportunity which even overseas entrepreneurs are tapping. Life Sciences companies in India have attracted investments but these are largely later stage companies. While hospital chains, day care centres, personal care products have attracted most of the investment, drug trials is almost at the bottom of the heap," revealed Ms Padmaja. Mr Ashwin feels that given the huge gap in the availability of basic health infrastructure in the country there is a lot of focus on single specialty chains, diagnostics and hospitals. "Therefore, areas like devices, information systems for the healthcare space, and pharma and biotech companies are currently lower on the radar of investment firms," he ended. Happening investment areas in Healthcare and Life Sciences  Apps Day care centres Diagnostics Disease management  Drug discovery Generics  Hospital chains Medical devices Mobile and digital health Pediatric care Personal care products Personalized treatments Telemedicine  Virtual monitoring Wearables Wellness   Top 5 cities attracting Healthcare and Life Science investments  Bangalore Chennai Delhi Hyderabad Mumbai Other hot destinations  Ahmedabad Chandigarh Coimbatore Himachal Pradesh Kolkata Orissa Pune Notable investment trends    In the last five years (FY11-15YTD) cumulative PE investments have doubled close to $5.5 billion in comparison to the investments between FY2005-2010YTD.  In volume terms, however, the number of transactions per annum have remained more or less the same over the past ten years (around 50-60 deals per year). The sector transactions in the last few years are now dominated by more mature stage deals (over $25 million transaction value) rather than early and growth stage transactions. This reflects the growing maturity of the sector and its ability to absorb further expansion capital to meet the continuing demand. Investments in healthcare delivery emerged more dominant over the years compared to investments in lifesciences.  Healthcare delivery presently accounts nearly 70 percent of total investments transacted. Factors driving VC investments  In pharmaceuticals, India's global competitiveness in manufacturing, regulatory and scientific strength makes it possible for investors to look at companies that capture market share and value in global generics. Investors look to capitalize on long-term domestic growth opportunities in healthcare and pharmaceuticals based on the increasing affordability and healthcare awareness among urban middle-class Indians. An estimated addition of 150 million people to the consuming middle-class over the next decade. Significant inequality in healthcare access in India owing to gap in healthcare infrastructure and workforce attract investors towards business models seeking to increase penetration of healthcare meeting rising demands. Key successful ventures  Amanta Healthcare  Consure Medical CromDx Glocal Healthcare Invictus Oncology Karmic Lifesciences  Lokmanya Hospitals Mitra Biotech  NovaLead Pharma Relisys Medical Devices  Sandor Nephro Services Shantani Proteome Analytics  Vyome Biosciences ]]> https://biospectrumindia.com/news/97/5651/now-electronic-skin-to-detect-breast-cancer.html https://biospectrumindia.com/news/97/5651/now-electronic-skin-to-detect-breast-cancer.html Thu, 25 Dec 2014 11:08:00 +0530 That in mind, scientists at the University of Nebraska - Lincoln, USA, have developed 'electronic skin' capable of detecting small lumps which can be overlooked by mammography or during manual examination with fingers. According to Dr Ravi Saraf, department of chemical and biomolecular engineering, University of Nebraska - Lincoln, USA, the device had been in the making for 3 years, which was put together by him and his co-author, a graduate student, Dr Chieu Nguyen. "Our goal was two-fold. First, to make CBE (clinical breast examination) quantitative so one can have an actual image for record keeping, Secondly, make it cheap so it can impact women world-wide where resources are limited. Record-keeping is critical in screening because the physician is looking for changes," opined Dr Ravi. The research has been published in the ACS Applied Materials & InterfacesOther than breast cancer, the electronic skin's applicability also extends towards melanoma screening. Speaking on the relevancy of this innovation in India, Dr Ravi revealed, "This device will be very attractive for the Indian market. The device is very easy to manufacture and is quite inexpensive to make. Because all it would need is a laptop. It can be administered in remote areas that does not have expensive infrastructure such as X-ray machines. A general physician will be able to use this instrument. One will not require a radiologist, such as for mammogram, to read the image."   According to Breast Cancer India, in 2012 alone, about 1,44,900+ fresh breast cancer cases were detected, and a staggering 70,000 women died because of it. Dr Ravi said that he'd be open to collaborate at both manufacturing, and medical trial level. "The device is used outside the body and it does not require rigorous toxicity considerations for medical trails," he held. ]]> https://biospectrumindia.com/features/97/4895/beginning-of-end-to-indian-cros.html https://biospectrumindia.com/features/97/4895/beginning-of-end-to-indian-cros.html Thu, 25 Dec 2014 10:19:00 +0530 Given the countries clinical trial woes already, the fresh new controversy seems to have given yet another major blow to India in the international clinical trials scene. The country is also tasting the bitter pill of witnessing the dwindling number of CROs.Four European Union (EU) countries including Belgium, France, German, and Luxembourg banned marketing authorizations of 25 generic drugs whose clinical tests were conducted by GVK Bio at its Hyderabad site. On December 5, 2014, the European Medicines Agency (EMA), the EU drug regulator, said on its website, "Some member states have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of studies conducted at the GVK Biosciences site in Hyderabad. EMA is currently reviewing findings of non-compliance with good clinical practice at this site, and determining their impact on medicines authorized on the basis of studies performed." The suspensions taken at national level are precautionary measures until the review is finalized, EMA said. The regulatory body now believes that GVK Bio has been 'systematically manipulating' its clinical studies. Data reliability EMA pointed that it started the review back in September 2014 post the inspection carried out by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French medicines agency, at the GVK Biosciences site, raising issues related on the reliability of studies conducted between 2008 to 2014.   ANSM conducted the inspections between May 19 to 23, 2014, at GVK Biosciences Hyderabad site. Rippling impact? Though there is no visibility on the revenue impact on GVK Bio following this announcement, Mr Joshua Owide, director, healthcare industry dynamics, GlobalData, said, ""The collateral damage to those companies implicated in the decision to suspend sales of GVK-associated products could be fairly significant, not only in terms of their revenue, but also their credibility as a whole." The banned products belonged to major drug-makers including US-based Abbott, Mylan, Teva and Zydus. Mr Owide believes that the most direct impact on GVK will be to its CRO business.   "India represents a key hub for clinical trials not only for domestic players, but also for multinationals, and there are already high levels of scrutiny surrounding the correct following of clinical trial regulations. This is exemplified by the announcement of new trial regulations enforced by Central Drugs Standard Control Organization (CDSCO), although it appears to be too-little-too-late in this case," he added. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Germany, noted that 'it has ordered drug manufacturers, wholesale dealers, medical stores and other outlets not to sell or use these medicines any longer.' The dispute In its official statement, GVK Bio disputed, "....We believe that the conclusions of the ANSM and the subsequent actions by the EMA are highly disproportionate to the actual risk posed to human health. At the same time, we respect and honor the conclusion made by the European regulators, and are working with our clinical development customers to provide new data that meets all regulatory requirements." When approached by BioSpectrum, GVK Bio refused to comment further. However, Mr Manni Kantipudi, CEO GVK Bio, told Reuters, "We have agreed to redo the studies. I'm fine with that, but don't say that there was gross manipulation of the ECGs." He also revealed that the company had received approval from its board to spend US $5.7 to 6.5 million for conducting fresh new studies on the same.   India's image hurt? Ms Suneela Thatte, president, Indian Society for Clinical Research (ISCR), expressed, "It is important to stress that there are several hundreds of clinical trials taking place in the country in compliance with international and local guidelines. There have been over 40 USFDA clinical trial audits done in India with no critical findings reported. There have also been several European regulatory audits of Indian clinical trial sites, again with no critical findings. Global studies have also shown that there is no difference in quality of data across geographies, including India." She feels that it is not as much about the ban as the imbalance between positive and negative news which is hurting the image of India in the clinical research world. "It is important that we use facts, statistics and data provided by leading organizations such as Association of Contract Research Organizations (ACRO) to build trust and confidence about the high quality and caliber of research being done in India," she stressed. Further recommendations   Now the EMA's Committee for Medicinal Products for Human Use (CHMP), a committee said to be responsible for preparing opinions on questions concerning medicines for human use, is expected to review GVK Bio's clinical data in question and then suitably suggest whether the suspended marketing authorizations will be maintained, varied or withdrawn across the EU territory. The recommendation is expected in January 2015, pointed EMA on its website. In a notification by the European Commission to the CHMP, the following findings were reported: Falsifications of electrocardiograms in each and every one of the 9 trials inspected by the ANSM Number of members of staff involved show lack of GCP training, awareness and understanding of members of GVK Bio staff, a lack of understanding by them of the importance of data integrity, and of the possible consequences of their acts, as well as a lack of overview of clinical trial activities by the investigators. The deputy spokeswoman at the Federal Institute for Drugs and Medical Devices told BioSpectrum, "The review is still ongoing. The CHMP opinion will be forwarded to the European Commission, which will adopt a legally binding decision." The experts also believe that depending on the gravity of the data review, CHMP might extend its inspection to studies conducted at GVK Bio prior to 2008.   Future of Indian CROs? Mr Owide said that when there is doubt over regulatory proceedings being correctly followed, overseas players remain judicial in their approach towards doing business with affected companies, regardless of the end product. "While India's healthcare sector has typically found success over other developing markets in terms of cost and qualification, it falls short, like many of these markets, in terms of regulatory standards being upheld. While there may be an element of protectionism by the relevant governing bodies in the EU, it ultimately serves as a warning sign for companies in India to retain the high standards that helped them to flourish and become major players in a global context," Mr Owide remarked. "We do not believe foreign regulators have any vested interest in singling out a particular country," Ms Suneela pointed. "In a global study where trials take place across markets and sites, any query over data at a particular site or in a particular country could put the entire study submission at high risk, and no regulator would want to risk that." Despite this, Mr Owide held, "India will remain a major hub for outsourcing, collaboration and partnership, provided it can learn from this lesson and follow new regulatory guidelines more closely to ensure the integrity of its life science sector." ]]> https://biospectrumindia.com/news/97/5652/clinovo-launches-latest-version-of-clincapture.html https://biospectrumindia.com/news/97/5652/clinovo-launches-latest-version-of-clincapture.html Thu, 18 Dec 2014 16:59:38 +0530 With the new release of Electronic Data Capture (EDC) system ClinCapture, sponsor companies, contract research organizations (CROs) and researchers will be able to streamline the development and management of clinical trials by creating and managing electronic case report forms (CRFs) without relying on professional services. "We are very proud of this new release, which will deliver unprecedented speed of implementation, flexibility and functionality to users," said Mr Glenn Keet, CEO, Clinovo. "The new features will give users the ability to create CRFs without having any sort of advanced programming or IT management skills, which represents a great leap forward in terms of usability for the industry." ClinCapture is cloud-based, hence users can manage one or several clinical trials from anywhere, at any time. Designing and creating CRFs will be faster and more straightforward with the drag-and-drop amenities, not to mention complex edit checks creation made simple-clinical trial managers can have these necessities completed in just a few days, making the processes extremely cost effective. "The self-service portal sets ClinCapture apart from other EDCs," said Mr Marc Desgrousilliers, CTO, Clinovo. "Efficiency is essential in this industry, and having everything you need to build CRFs at your fingertips is exceptional. ClinCapture is also the only open source EDC with an integrated, intuitive randomization function and is one of the only WHO drug certified EDCs -proving Clinovo's technological leadership." ]]> https://biospectrumindia.com/news/97/4961/perkinelmer-completes-perten-instruments-acquisition.html https://biospectrumindia.com/news/97/4961/perkinelmer-completes-perten-instruments-acquisition.html Thu, 18 Dec 2014 14:16:22 +0530 PerkinElmer has announced that the company has completed its acquisition of Perten Instruments Group AB. Perten is a Stockholm, Sweden-based leading global supplier of advanced analytical instruments for quality control of food, grain, flour and feed. The completion of the acquisition is not expected to have a material impact on PerkinElmer's results for the fourth quarter of 2014.   ]]> https://biospectrumindia.com/news/97/4639/abbott-launches-iridica-in-europe.html https://biospectrumindia.com/news/97/4639/abbott-launches-iridica-in-europe.html Thu, 18 Dec 2014 13:24:47 +0530 Abbott has announced that its innovative diagnostic platform, IRIDICA, is now available in Europe and other CE-Mark recognized countries. The new platform can identify more than 1,000 infection-causing pathogens in less than six hours, versus the current standard of care (culture-based testing), which can take days. IRIDICA uses a combination of sophisticated testing technologies known as Polymerase Chain Reaction/Electrospray Ionization Mass Spectrometry (PCR/ESI-MS) to rapidly identify infection-causing pathogens directly from a patient's sample, without the need for culture. According to Abbott's RApid Diagnosis of Infections in the CriticAlly IlL (RADICAL) study results, the technology was able to detect pathogens when the current standard of care did not. An analysis of the study results suggested that Abbott's technology could help lower associated health care costs by 30 percent and reduce hospital stays for people with serious infections by up to eight days. "Currently, when a person enters a hospital with a suspected infection, it may take several days before the source can be accurately identified, which can delay appropriate treatment. IRIDICA can offer a better and faster way to detect and identify pathogens that cause serious infections and aid physicians in diagnosing and managing the critically ill," said Mr David J Ecker, divisional vice president, R&D for Abbott's Ibis Biosciences business. IRIDICA currently offers five testing panels for pathogens that cause infections in the critically ill such as sepsis; other bacterial, fungal and viral infections; and ventilator-associated pneumonia.   ]]> https://biospectrumindia.com/features/97/6741/nanotechnology-in-healthcare.html https://biospectrumindia.com/features/97/6741/nanotechnology-in-healthcare.html Thu, 18 Dec 2014 09:23:00 +0530 The scope of nanotechnology in healthcare is in finding applications in diverse areas such as tissue engineering, nanomedicines, diagnostic tools, image enhancement devices, nanorobots, implant technology, biosensors, biomarkers, bioactive surfaces, and as carriers of diagnostic and therapeutic modalities. According to Dr Tuhin Bhowmick, chairman, Pandorum Technologies, a Nano-tech start-up, there are five major applications of Nanotechnology in healthcare sector, i.e., drug delivery systems, therapeutics, medical materials and implants and analytical tools and instruments and diagnosis. CKMNT carried out a detailed scientific analysis using the web of science database to identify major applications for nanotechnology in the healthcare sector worldwide during the period of 2000-2014. According to CKMNT analysis, the major applications of nanotechnology in the healthcare sector are in the field of biochemistry, followed by pharmacology. This is based on peer reviewed research publications in each area. Market Nanotechnology is a growing interdisciplinary technology seen as a new industrial revolution. It is increasingly attracting worldwide attention owing to its wide range of applications. The global nanotechnology market is anticipated to grow at a Compounded Annual Growth Rate (CAGR) of around 16.5 percent during 2014-2020 according to a Research and Markets report. Dr Purushottam further highlighted, "According to Lux Research, the estimated global market opportunity for nanotechnology-based products by 2015 is about $1.0 trillion and about 1,500 nanotechnology based products are in the market. However, the current market size of nanotechnology in India would be around Rs 10,000-15,000 crore." CKMNT estimates that over the next 10-15 years, the domestic nanotechnology market in this segment will grow upto $ 1.6 billion at a CAGR of 47 percent, with the potential to reach $2.1 billion. It is expected that in the next 10-20 years, the market will be flooded with nano-based medicines and drug delivery systems as well as nano-enabled ultrasensitive and rapid detection devices for diagnosis and therapy. ]]> https://biospectrumindia.com/news/97/4575/eppendorf-india-receives-expanded-nabl-accreditation.html https://biospectrumindia.com/news/97/4575/eppendorf-india-receives-expanded-nabl-accreditation.html Wed, 17 Dec 2014 16:51:00 +0530 With the existing NABL accreditation for Pipette calibration, Eppendorf India receives expanded NABL accreditation for calibration service in accordance with ISO/IEC 17025:2005 for Temperature (Thermal), Speed (Mechanical) and Time (Electro-Technical). The company can perform these NABL calibration onsite for various laboratory instruments such as centrifuges, incubators (CO2 and BOD), incubator shakers, freezers (Cryo, ULT, -45 °C, -20 °C), Thermomixer or dry bath, water bath, autoclave, etc. Calibration and certification of performance of instruments make sure that instruments are performing to specifications. With the accreditation range of +200°C to -195°C for Temperature, 25 rpm - 30000 rpm for Speed and 60 sec to 3600 sec for Time, it can now provide a certified calibration for a range of laboratory instruments. ]]> https://biospectrumindia.com/news/97/4522/scientists-create-3d-map-of-genome.html https://biospectrumindia.com/news/97/4522/scientists-create-3d-map-of-genome.html Wed, 17 Dec 2014 13:19:00 +0530 Researchers at the Harvard University, Baylor College of Medicine, Rice University and the Broad Institute of Harvard and MIT have assembled high-resolution 3D maps of entire folded genomes, showing how a 'genomic origami' or folding allows the same genes to produce different cells. "More and more, we are realising that folding is regulation. When you see genes turn on or off, what lies behind that is a change in folding. It's a different way of thinking about how cells work," said study co-first author Mr Suhas Rao, a researcher at Baylor's Centre for Genome Architecture. Researchers used a technology called "in situ Hi-C" to collect billions of snippets of DNA that were later analyzed for signs of loops. The team found that loops and other genome folding patterns are an essential part of genetic regulation. "Our maps of looping have revealed thousands of hidden switches that scientists did not know about before. In the case of genes that can cause cancer or other diseases, knowing where these switches are is vital," said co-first author Ms Miriam Huntley, a doctoral student at Harvard's School of Engineering and Applied Sciences. According to the researchers, the new maps allows to really see what folding looks like at the level of individual genes.   The research is published in the journal Cell.   ]]> https://biospectrumindia.com/news/97/4562/prajhipurity-systems-adds-new-products-to-its-portfolio.html https://biospectrumindia.com/news/97/4562/prajhipurity-systems-adds-new-products-to-its-portfolio.html Tue, 16 Dec 2014 12:43:00 +0530 PrajHiPurity Systems (PHS) has introduced 'BioWiz', a Smart Bioreactor, which will help the biopharma industry meet the various bio processor requirements in laboratory, pilot, and commercial units. BioWiz Bioreactor benchmarks international standards and delivers superior operational features and advantages required in the  global pharmaceutical industry. Some of its key features are cost effective design as per International Standards like cGMP, GEP, and GDP, 'Golden Batch' concept for real time comparison of process parameters, advance automation - PLC-SCADA-based system, in-built safety parameters and web based remote monitoring. Commenting on the BioWiz Bioreactor, Mr Gajanan Nabar CEO and MD of Praj Industries and Mr Mihir Mehta, BU head of PHS said, "A well-engineered process solution plays a significant role in defining efficient functioning of the production facility. High Purity industries like pharmaceuticals, biotechnology, healthcare and cosmetics are characterized by stringent demands on sterile and hygienic design and engineering. Manufacturing systems are required to meet high quality standards and guidelines set by international authorities like ISPE or ASME BPE. It is in this context that the BioWiz Smart Bioreactor has a major impact on productivity, quality and profitability of any manufacturing plant." PHS also introduced new models of its 'Glacier' Water System. It is used to generate pure, sanitized water for pharma and biotech applications. The new system comes with advanced features like 'one touch' sanitization operation, complete plug and play operation, easy access for O&M with reduced footprint. Introducing 'Glacier' Mr Nabar said, "This is the outcome of our continued R&D to offer best-in-class high purity water system with highest hot water sanitization cycles. It's plug and play feature saves time and energy."   ]]> https://biospectrumindia.com/news/97/4279/ges-new-offering-to-detect-cancer-early.html https://biospectrumindia.com/news/97/4279/ges-new-offering-to-detect-cancer-early.html Mon, 15 Dec 2014 14:31:31 +0530 GE Healthcare has unveiled Discovery IQ, an advanced Positron Emission Tomography/ Computed Tomography (PET/CT) molecular imaging system designed in India. The new Discovery IQ is the result of $15 Million (INR 90 Crores) investment, and three years of close collaborative development with Indian nuclear medicine physicians and oncologists. The new GE Discovery IQ PET/CT comes with advanced early disease detection capabilities as well as measurements to understand patient's response to cancer treatment. "GE's Discovery IQ PET CT is disruptively innovated in India in collaboration with Indian oncologists and academicians with the primary mission of increasing access to affordable cancer care for India," said Mr Terri Bresenham, president and CEO, GE Healthcare South Asia. Sri Ramakrishna Institute of Oncology and Research, Coimbatore has installed this sophisticated CT Scan machine. The Institute claimed that it is the first hospital in the country to install the device. Mr P Guhan, director of the institute said, "By the use of this technology the hospital would be able to detect cancer at an early stage, individualise the treatment, assess treatment response and detect cancer recurrence."       ]]> https://biospectrumindia.com/news/97/4092/now-diagnose-disease-digitally.html https://biospectrumindia.com/news/97/4092/now-diagnose-disease-digitally.html Fri, 12 Dec 2014 17:11:00 +0530 Researchers at VIT University have developed a new diagnostic system that combines the inputs of described symptoms with a digital analysis of an image of the patient's tongue. "The approach basically includes a combination of soft and hard inputs. Soft inputs include a variety of common symptoms such as fever, headache and cough. Each selected disease corresponds to a variety of general symptoms," said Mr Karthik Ramamurthy who devised the diagnostic system along with his colleagues. "Hard inputs include images of the tongue as it is widely used by the doctor to diagnose the various disorders," he added. The analysis of these inputs are then fed to a neural network or computational model. The network is trained with four different algorithms and the image is analysed. The digitised image of the patient's tongue could reveal discolouration, engorgement, texture and other factors that might be linked to illness like smoothness and "beefiness" might reveal vitamin B12, iron, or folate deficiency.   The current system allows diagnosis of fourteen distinct conditions but the team adds that they will be able to add eye images and use those as an additional hard input for their neural network and so extend its repertoire significantly. The study appeared in the International Journal of Biomedical Engineering and Technology.   ]]> https://biospectrumindia.com/news/97/4004/sigma-aldrich-stockholders-approve-acquisition-by-merck-kgaa.html https://biospectrumindia.com/news/97/4004/sigma-aldrich-stockholders-approve-acquisition-by-merck-kgaa.html Thu, 11 Dec 2014 15:52:00 +0530 Sigma-Aldrich Corp's stockholders voted to adopt the previously announced merger agreement providing for the acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, at a special meeting of stockholders. Sigma-Aldrich stockholders also approved, on an advisory, non-binding basis, compensation that may become payable to named executive officers as a result of the acquisition. As previously announced, on September 22, 2014, the board of directors for Sigma-Aldrich approved the merger agreement under which Merck KGaA will acquire Sigma-Aldrich for $140.00 per share in cash. The transaction, which is expected to close in mid-2015, remains subject to the satisfaction of the closing conditions set forth in the merger agreement, including regulatory approvals. ]]> https://biospectrumindia.com/news/97/3983/gvk-bio-refutes-data-manipulation-in-drug-studies-.html https://biospectrumindia.com/news/97/3983/gvk-bio-refutes-data-manipulation-in-drug-studies-.html Thu, 11 Dec 2014 15:51:10 +0530 Recently, European Medicines Agency (EMA) in a statement said that four EU Member States have decided to suspend marketing authorizations of medicines authorized on the basis of studies conducted at the GVK Biosciences site in Hyderabad. Refuting this, Mr Manni Kantipudi, CEO, GVK Bio, stated: "The regulatory authorities have themselves stated that, 'This decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs'. We believe that the conclusions of the ANSM ((Agence Nationale de sécurité du médicament et des produits de santé) and the subsequent actions by the EMA are highly disproportionate to the actual risk posed to human health. At the same time, we respect and honor the conclusion made by the European regulators, and are working with our clinical development customers to provide new data that meets all regulatory requirements." ]]> https://biospectrumindia.com/news/97/6054/sigma-aldrich-life-sciences-licenses-patents-from-broad-institute.html https://biospectrumindia.com/news/97/6054/sigma-aldrich-life-sciences-licenses-patents-from-broad-institute.html Thu, 11 Dec 2014 14:25:08 +0530 Sigma-Aldrich has announced that Sigma Life Science, its innovative biological products and services business, has entered into a non-exclusive agreement for the use of CRISPR/Cas technology covered under patents held by the Broad Institute of MIT and Harvard. Under the agreement, Sigma-Aldrich is able to make, use and distribute the advanced gene editing tools for numerous research applications, including the generation of modified plant and animal models, custom cell line creation and for CRISPR/Cas arrayed and pooled genetic screening. "This is an important step in our long-running research partnership with the Broad Institute," said Mr Shaf Yousaf, vice president of technology and business development, Sigma-Aldrich. He added, "We share the Broad's passion for leading the way in research with new ideas and tools. Sigma-Aldrich's scientists have been developing genome editing reagents for years, and have been using them in our own labs to make custom cell lines for everything from cancer drug screens to ADME-Tox assays. As both the maker and user of these reagents, Sigma-Aldrich offers a tremendous amount of expertise for guiding our customers." This agreement enables Sigma-Aldrich to pair its lentiviral manufacturing core competency and genome editing expertise with CRISPR to create the next generation of screening tools: pre-designed or customizable individual lentiviral CRISPR clones and off-the-shelf or custom lentiviral CRISPR pools. The company is also the exclusive distributor of the Broad Institute's complete Mission shRNA and ORF libraries.   ]]> https://biospectrumindia.com/news/97/6056/agilent-technologies-baylor-college-of-medicine-tie-up.html https://biospectrumindia.com/news/97/6056/agilent-technologies-baylor-college-of-medicine-tie-up.html Thu, 11 Dec 2014 14:23:00 +0530 Agilent Technologies and Baylor College of Medicine has joined hands to advance research and training in the field of metabolomics. They have opened the Agilent Technologies Mass Spectrometry Center of Excellence as part of the Alkek Center for Molecular Discovery and the Baylor College of Medicine Core Laboratory in the college's department of molecular and cellular biology. "Our collaborative relationship with Baylor and our shared investment in this new center will foster development of advanced research tools and new applications in metabolomics and integrated biology," said Mr Carl Raimond, Agilent vice president of Sales and Field Operations, Americas Life Sciences. "The growing significance of metabolomics, not only in lifescience research but in many application spaces, has resulted in the need for more analytical capabilities," said Dr Arun Sreekumar, co-director of the Alkek Center. He added, "Baylor and Agilent have identified several areas of mutual interest-metabolomics, lipidomics, clinical research, disease research-where we believe we can make real progress together." Agilent is equipping the new center with two systems configured for metabolomics: an Agilent 6495 triple quadrupole LC/MS system and an Agilent 6550 iFunnel quadrupole time-of-flight LC/MS system with a switchable GC APCI interface. The systems include Mass Hunter software for qualitative and quantitative analysis as well as Mass Profiler Professional with Pathway Architect for bioinformatics and integrated multi-omic analysis. Both Baylor and Agilent will use the equipment collaboratively to analyse samples, conduct research and train students.   ]]> https://biospectrumindia.com/news/97/3940/pall-corporations-cfo-resigns.html https://biospectrumindia.com/news/97/3940/pall-corporations-cfo-resigns.html Thu, 11 Dec 2014 12:15:11 +0530 Pall Corporation has announced that Mr Akhil Johri, Chief Financial Officer (CFO), has tendered his resignation, effective December 19, 2014, to become CFO of United Technologies Corp. The Company is currently evaluating its succession options. "We thank Akhil for his service to Pall and wish him the very best in his future career," said Mr Larry Kingsley, chairman and CEO.   ]]> https://biospectrumindia.com/news/97/4916/nanotech-to-detect-environmental-pollutants.html https://biospectrumindia.com/news/97/4916/nanotech-to-detect-environmental-pollutants.html Wed, 10 Dec 2014 11:32:04 +0530 "The bionanocomposite materials can be integrated in diagnostic platforms for the detection of pesticides and toxins in real environmental samples and further they are having verstaile application son clinical diagnosis," said Dr Priyanka, scientist "C" at the Institute of Nano Science and Technology, Mohali and one of the speakers at the 7th Bangalore India Nano. The three-day event was held from Dec 4-6 2014 at Bangalore, which is also touted as nano capital of the world. Dr Priyanka is currently working on developing nano-bio probe mediated low cost diagnostic platforms for clinical and environment pollutants. Many renowned national and international speakers delivered keynote lectures at the conference highlighting its application in various fields like medicine, devices and sensors, advanced materials, automanufacturing etc. "Medical devices, regenerative medicines, drug delivery and medical implants are some of the areas where nanoscience has find its applications in healthcare," said Dr Shantikumar V Nair, dean of Research, Amrita Vishwa Vidyapeetham University and director of the Amrita Center for Nanoscience and Molecular Medicine. He was felicitated with the Prof. CNR Rao Bangalore India Nano Science Award 2014 at the event for his outstanding contribution for the growth of nanotechnology in the country. "Nanotech in the sunrise sector nanotech holds a great promise for many of the daunting problem that the mankind is facing. Our government will ensure single window clearance for nanotech industry on the lines of other industries," said Mr SR Patil, minister of IT&BT, government of Karnataka at the inaugural function. ]]> https://biospectrumindia.com/news/97/6047/gvk-bio-strengthens-tie-up-with-ctc-life-science-japan.html https://biospectrumindia.com/news/97/6047/gvk-bio-strengthens-tie-up-with-ctc-life-science-japan.html Tue, 09 Dec 2014 14:46:11 +0530 The drug repurposing platform called GRIP (GVK Bio Repurposing Integrated Platform) is a combination of several GVK Bio proprietary and several public domain databases. It calls for reinvestigating the marketed drugs, clinical and/or pre-clinical candidates and can be applied to many different compounds including those that have failed to show efficacy in late stage clinical trials. GVK offers a full blown drug repurposing collaborative research services starting from in-silico hypothesis generation to IND enabling studies under one roof. In addition, GRIP is capable of addressing drug-based, target-based and disease-based repurposing requests and also for generic drugs and innovative compounds (drugs with patent validity, shelved, and pre-clinical stage). Underlying the Drug Repositioning process is a set of 8 distinct algorithms that allow for unbiased interpretation of the input data to predict alternative indications.   Supplementing GRIP is a team of PhD level scientists and clinicians who help in the accurate interpretation of the data. GVK Bio and CTCLS have been working together for the past 10 years on marketing and distribution of GVK BIO's GOSTAR, GOBIOM and Clinical Outcomes Databases along with Custom Data Curation Services. Mr Ryouji Yokoyama, president and CEO, CTCLS, said, "Drug Repositioning has recently grown across the pharmaceutical industry, generating not only clinical development but also business growth. Such trend has been driven by necessity, because the new drug approval rate in Japan has been falling over recent years. Yet the biggest reason for the rising interest in drug repositioning is that it is considered as one of important ways to deliver safer drugs to patients faster and more reliably by discovering new indication from approved drugs and dropout compounds with already confirmed safety and pharmacokinetic properties. In an effort to meet increased demands and challenges, CTCLS has strengthened the sales and marketing of GVK Bio's drug repositioning service by an alliance with GVK Bio. From now on, CTCLS will provide high quality service which can support expanding adaption disease of approved drugs owned by pharmaceutical companies." ]]> https://biospectrumindia.com/news/97/4235/gvks-drug-studies-suspended-by-4-eu-countries.html https://biospectrumindia.com/news/97/4235/gvks-drug-studies-suspended-by-4-eu-countries.html Tue, 09 Dec 2014 14:04:25 +0530 The EMA is currently reviewing findings of non-compliance with good clinical practice at this site and determining their impact on medicines authorized on the basis of studies performed at the site. These suspensions taken at national level are precautionary measures until the review is finalized. EMA started the review in September 2014 following an inspection carried out by the French medicines agency at the GVK Biosciences site which raised concerns about the reliability of studies conducted at the site between 2008 and 2014. As part of the review, the EMA's Committee for Medicinal Products for Human Use (CHMP) is identifying, together with Member States of the European Union (EU), which medicines are affected by the inspection findings. The review will provide a robust scientific assessment of all data and determine the impact of the findings on the concerned medicines, enabling Member States to take adequate EU-wide action to protect patients' health.   EMA will issue a recommendation on whether the marketing authorizations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU. The recommendation is expected in January 2015. ]]> https://biospectrumindia.com/news/97/5036/blackberry-and-nanthealth-launch-nantomics-cancer-genome-browser.html https://biospectrumindia.com/news/97/5036/blackberry-and-nanthealth-launch-nantomics-cancer-genome-browser.html Tue, 09 Dec 2014 13:34:49 +0530 BlackBerry and NantHealth have announced the launch of a new browser from their stable, called the NantOmics Cancer Genome Browser. It gives doctors unprecedented access to patients' genetic data on the BlackBerry Passport smartphone. It is the first in a series of innovative offerings being developed jointly by BlackBerry and NantHealth for use by healthcare professionals. "BlackBerry's partnership with NantHealth illustrates how mobile security and collaboration technology we are known for can be reimagined to create revolutionary applications across a variety of industries. BlackBerry technology has proven itself secure, reliable, and powerful enough to be counted on in life-and-death situations. Its innovative form and functionality make BlackBerry Passport an ideal addition to a doctor's medical kit," said Mr John Chen, executive chairman and CEO, BlackBerry. "The proprietary NantOmics Cancer Genome Browser enables clinicians for the first time to investigate a tumor genome from the full three billion bases down to the single-base level in real-time, thanks to the power of the NantOmics supercomputing infrastructure," said Mr Patrick Soon-Shiong,founder and CEO of NantHealth. He added, "This integrates with NantHealth's treatment recommendation engine, Eviti, to personalise treatment protocols to individual patients based on their genomic signature." The NantOmics Cancer Genome Browser is fully encrypted to allow deployment in a HIPAA-secured environment, enabling clinicians to securely access patient data as soon as it's available, wherever they are. BlackBerry's recently launched BES12 cross-platform EMM solution will enable hospital IT administrators to easily deploy the application to a clinician's BlackBerry Passport smartphone and ensures that the application data is fully secure end-to-end.   The Browser will be preloaded on BlackBerry Passport devices and available to the professional community in early 2015.   ]]> https://biospectrumindia.com/news/97/1315/wipro-named-star-performer-in-everest-group-life-sciences-peak-matrix-2014.html https://biospectrumindia.com/news/97/1315/wipro-named-star-performer-in-everest-group-life-sciences-peak-matrix-2014.html Mon, 08 Dec 2014 18:29:39 +0530 Speaking on the recognition, Ms Sangita Singh, chief executive - healthcare and lifesciences, Wipro, said, "This recognition can be attributed to our domain focus, best-of-breed technology and delivery excellence in a comprehensive portfolio of services equipped to address the demands of rapidly-modernizing industries." Wipro strengthened its position by ramping up proprietary solutions, augmenting resources, deepening domain expertise and demonstrating an increased traction with large life science firms. The geographical scope of these contracts spans North America, Europe and Asia-Pacific (APAC). "A new surge in life sciences IT outsourcing is driven by application portfolio modernization, infrastructure transformation, and analytics. Life sciences enterprises are increasingly preferring service providers who can provide a blend of traditional and next-generation services," said Mr Abhishek Singh, practice director, Everest Group. ]]> https://biospectrumindia.com/news/97/6055/toshiba-introduces-new-ultrasound-devices.html https://biospectrumindia.com/news/97/6055/toshiba-introduces-new-ultrasound-devices.html Mon, 08 Dec 2014 14:25:26 +0530 Toshiba America Medical Systems has introduced new ultrasound devices, called the Aplio 300 and 500 Platinum Series respectively. This enhancement to the company's existing Aplio 300 and 500 systems expands the clinical utility of ultrasound, allowing providers to consolidate lines of care onto a single platform. The Aplio Platinum series provides powerful clinical imaging tools for advanced visualisation, quantification and intervention. This includes BEAM, a new technique that improves needle visualisation during ultrasound-guided procedures. On the Aplio 500 Platinum, Shear Wave elastography is a new tool to non-invasively measure tissue stiffness of the liver and potentially reduce expensive biopsies, while Superb Micro-Vascular Imaging (SMI) can capture low-velocity blood flow without the need for contrast agents or more invasive modalities. "We understand our customers' business and enhanced our premium radiology systems with new technologies and improved existing ones like Smart Fusion and Fly Thru. The Aplio Platinum Series offers our customers a patient-centric system that expands the clinical utility of ultrasound and provides a safer, less invasive and more cost-effective solution," said Mr Tomohiro Hasegawa, director, ultrasound business unit, Toshiba.   ]]> https://biospectrumindia.com/news/97/5802/indian-students-career-revolve-only-around-it.html https://biospectrumindia.com/news/97/5802/indian-students-career-revolve-only-around-it.html Mon, 08 Dec 2014 10:03:00 +0530 The conference sought after promoting awareness on the applications of Next Generation Sequencing (NGS) technologies and bioinformatics for NGS among the Indian research community. This year's 4th edition of the conference was graced by Dr P Satish Chandra, director and vice-chancellor, NIMHANS. In his inaugural address, he said, "Our country has unique health issues and we need to find solutions. I don't think anyone else will work on our problems. We have been working on genetics for some time looking at rare disorders and genes associated with them." Focusing on the neurological disorders, he opined, "There are rare disorders and we don't know much yet as to what causes them. Thus it is a fertile ground which needs to be probed. Nimhans has special interest in neurodegenerative disorders as they are complex and needs a lot of work." The Life Sciences job and internship fair, a major highlight of the conference, drew many job seekers, researchers and students.   Companies including Biocon, InterpretOmics, Genotypic Technology, Thermo Fisher Scientific, Future Bio Science, Shodhaka Life Sciences and SciGenom Labs were found fishing for the right applicants for their available vacancies. The job fair session was hosted by Mr Tony Jose, CEO, Clevergene, who pointed that in India many students' careers revolve only around information technology (IT). "At times LinkedIn becomes way too slow and expensive. In the life sciences, there are no common outreach platforms for job seekers. To address this we started BioHiring, a tool to help candidates in finding jobs and internships," he revealed. 'BioHiring' is a soon-to-be launched web platform created by Clevergene for hiring potential candidates in the Life Sciences space. This platform is said to open the door for meaningful interactions between employers and job seekers. Speakers including Dr C N Ramchand, CEO, Saksin Lifesciences; Dr Kshitish Acharya, founder & director, Shodhaka Life Sciences; and Ms Anu Sharma, founder, The HR Practice, spoke on the industry challenges in finding the right talent pool and offered helpful insights into hiring dynamics, facing interviews and creating catchy curriculum vitaes (CVs). Dr Ramchand, former VP and head of drug discovery research at Sun Pharmaceuticals, who has experience in hiring candidates pointed that India is a home to 22,000 pharmaceutical companies, out of which only 100-200 organizations are very large. "Worldwide we represent only 2-3 percent in terms of quality and quantity. Post 1995 when the product development patent was signed in India, pharma companies began setting up their research base here. Ranbaxy, Dr Reddy's, Sun Pharma and Glenmark began their drug discovery research here," he recalled. He held that unfortunately no pharma company in India so far has been able to discover any new drugs. "Dr Reddy's came up with 2 to 3 molecules up to phase-2. Sun's molecules reached till phase-3 and failed. This is an unfortunate situation," he lamented. Dr Ramchand questioned why India was unable to shine in drug discovery. "Is it because of lack of capital? I don't think so," he stated. "Large organizations have enough funds to invest in drug discovery." Talking about hiring trends, he commented, "GlaxoSmithKline (GSK) used to interview about 150 candidates to hire one single candidate who is employable. When you move up north in India, it is easier to find such candidates than down south. I have no idea why this is." He also expressed that in the US, teachers opt for teaching out of pure interest. "Unfortunately here in India, if nothing works out, then candidates become teachers, because engineering and medicine are sought after by most of the students. Poor teachers pose a major problem," he added. For students aspiring to pursue careers in Life Sciences, Dr Ramchand advised, "When applying at an institution, find out at least 1 or 2 good motivating teachers. Seek institutions where good research is happening which will open avenues for learning new technologies and fundamentals. Technologies are changing very fast. Sadly, our syllabuses change once in three years or so. If you get an opportunity to study PhD in an organization or an industry-sponsored environment, you will learn a lot more. The masters programs in UK is just for a year and you learn nothing." Another speaker, Ms Anu Sharma presented on tackling interviews and understanding hiring process from a human resource (HR) professional perspective. "The pressure on HR is unbelievable. They have set targets and numbers to adhere to. Finding and hiring the right personnel is highly challenging," she said. "Learn as much as you can about why the company exists, what their business models are. Familiarize yourself with their website and online presence, the work they do, and their markets. You can even check out the LinkedIn profiles of key people in the organization that you are interested in and learn about the company's leadership," she told participants. Ms Anu feels that there are adequate jobs in the market. "The responsibility to get a job is your responsibility. Make your CV compelling that recruiters would want to call you," she opined. As a tip, she said, "Adding the same keywords in your CV that employers use in a job advertisement will increase your chances of getting hired. Also, you have to mandatorily have some industry experience, and mention the projects and internships you have completed." In her concluding remarks, Ms Anu summarized, "Always work and simultaneously hunt for a job. The interview is not a viva voce. Know your basics. Communication is the key here. Industry linkages, an outstanding CV and knowledge about the industry are major catalysts." The NGBT 2014 conference had concurrent session covering an array of themes including Genomics Technologies, Plant Genomics, Clinical/Medical Genomics, Animal/Conservation Genomics, Drug Development, Population Genomics and Disease Genomics among others. A separate poster display aisle was also set up for students and researchers at the conference. The keynote address was by Dr Stephan C Schuster, research director, Nanyang Technological University (NTU), Singapore, who delivered a presentation on 'Population Genomics and Informed Breeding Aid Species Conservation'. ]]> https://biospectrumindia.com/news/97/6791/masimos-wearable-device-passes-usfda-clearance-.html https://biospectrumindia.com/news/97/6791/masimos-wearable-device-passes-usfda-clearance-.html Thu, 04 Dec 2014 12:42:28 +0530 Masimo announced FDA 510(k) clearance of Radius-7 for the Root patient monitoring and connectivity platform, the first and only wearable, wireless monitor with Masimo's rainbow SET technology. With rainbow SET noninvasive measurements, Radius-7 with Root can alert clinicians - at the bedside or remotely, through the Masimo Patient SafetyNet remote monitoring and notification system - of critical changes in a patient's oxygen saturation and pulse rate - even during states of motion and low perfusion - as well as respiration through acoustic respiration rate (RRa). Lightweight at only 0.34 lbs (155g), the Radius-7 attaches to the patient's arm or can be placed alongside the patient in their bed, allowing untethered monitoring while they are in bed or out. With no need to disconnect and reconnect the cable to get out of bed, the Radius-7 reduces the need for nursing assistance. And the Radius-7's wireless communication functionality - either short-range via Bluetooth back to Root or with upgradeable WiFi for long-range communication - ensures the patient can be continuously monitored and connected to caregivers wherever they are in the hospital.   Studies have shown that patient mobility is a key factor in more rapid patient recovery. Radius-7 allows clinicians to continuously monitor their patients when they are mobile. ]]> https://biospectrumindia.com/news/97/6057/thermo-fisher-scientific-launches-nxtype-kit-.html https://biospectrumindia.com/news/97/6057/thermo-fisher-scientific-launches-nxtype-kit-.html Thu, 04 Dec 2014 10:38:00 +0530 One Lambda, part of Thermo Fisher Scientific has launched its RUO NXType Kit, a research use only (RUO) solution for human leukocyte antigen (HLA) typing by next-generation sequencing (NGS). The NXType sequencing kits feature long-range primers and an improved chemistry on the Ion Torrent Personal Genome Machine (PGM) system, enabling full-range sequencing of HLA Class I and II genes in three days. In addition to the PGM instrument, the NXType workflow includes, a comprehensive kit containing HLA Primer Mixes, ancillary reagents and TypeStream, One Lambda's exclusive NGS Analysis Software. The NXType workflow also includes a comprehensive customer support system that provides users with in-depth training and technical support to ensure a smooth transition to this new technology. "One Lambda has successfully streamlined our NGS workflow with their new NXType Kit by greatly improving the efficiency on the PGM platform. The pooling of the library preparation and enhanced workflow has given the NXType Kit and the PGM platform a distinct advantage in the NGS HLA typing arena. One major advantage with NXType is that one technologist in a laboratory can now fully sequence HLA Class I and II genes within three working days," said Dr Susan Hsu of the American Red Cross in Philadelphia. The new NXType assay brings together a unique, three-day workflow that is suitable for many laboratory applications and can be customised to handle a range of sample sizes. It uses a five-step process that enables the user to take a methodical, time-saving approach to high resolution HLA typing.   ]]> https://biospectrumindia.com/news/97/6053/bosch-klenzaids-create-jv-to-expand-reach-in-liquid-pharmaceuticals-.html https://biospectrumindia.com/news/97/6053/bosch-klenzaids-create-jv-to-expand-reach-in-liquid-pharmaceuticals-.html Wed, 03 Dec 2014 14:37:51 +0530 The JV is expected to employ some 380 associates, and the plan is subject to the approval of the antitrust authorities. Bosch will acquire a 49 percent share in Klenzaids, an owner-managed company that produces processing, packaging, and clean-room technology for the global pharmaceutical industry. The purchase price for the shares acquired by Bosch was not disclosed. The joint venture is set to be headquartered in Mumbai. By setting up the joint venture, the two partners aim to extend their global reach, particularly in liquid pharmaceuticals and packaging machines for clean-room environments. Klenzaids generated sales of around €6 million in 2013 and employs 350 people. Bosch Packaging Technology, which last year achieved global sales of €1.1 billion and employs some 5,600 associates worldwide, already has a presence in India through its Verna location in the state of Goa. ]]> https://biospectrumindia.com/news/97/5752/shimadzu-presents-a-new-spectrophotometer.html https://biospectrumindia.com/news/97/5752/shimadzu-presents-a-new-spectrophotometer.html Wed, 03 Dec 2014 14:12:33 +0530 Shimadzu has announced the launch of its new UV-3600 Plus UV-VIS-NIR spectrophotometer. The new spectrophotometer is equipped with three detectors - PMT (photomultiplier tube) for ultraviolet and visible regions, and InGaAs and cooled PbS detectors for the near-infrared region - to ensure high sensitivity across the entire measured wavelength range. Compared to spectrophotometers with only PMT and PbS detectors, the UV-3600 Plus significantly reduces noise level to assure high-accuracy measurements across the entire wavelength range. The instrument's high-performance double monochromator makes it possible to attain an ultra-low stray light level (0.00005 percent max at 340 nm) with high resolution. The wide wavelength range of 185 to 3,300 nm enables measurement across the ultraviolet, visible and near-infrared regions. The UV-3600 Plus offers high-resolution analysis in the following application areas: materials science, including photovoltaics, electronics, optical coatings, and textiles; food science; pharmaceuticals, cosmetics and lifesciences; and chemicals. The all-in-one UVProbe software is equipped with four measurement modes to handle a wide variety of data processing needs for the UV-3600 Plus, such as peak detection and area calculations in addition to transformations such as derivative spectra and Kubelka-Munk transforms for reflectance measurements. These modes include a spectrum module, a photometric module (quantitation), a kinetics module (time course management), and a report generator. Optional software is also available for users who wish to perform measurements such as color analysis, solar transmittance, band gap, and film thickness   ]]> https://biospectrumindia.com/news/97/5780/ge-healthcare-unveils-a-new-mri-system.html https://biospectrumindia.com/news/97/5780/ge-healthcare-unveils-a-new-mri-system.html Wed, 03 Dec 2014 12:58:23 +0530 GE Healthcare unveiled its new SIGNA Pioneer 3.0 Tesla MRI system that comes with a revolutionary new imaging technique called MAGiC, which reduces imaging times by up to two-thirds. MAGiC is an MR technique that allows for the acquisition of multiple image contrasts at the same time. With this technique, a single scan that delivers six contrasts can be completed in as little as one-third the total time taken to acquire each contrast separately using conventional techniques. An enhanced SilentScan package is also available on SIGNA Pioneer, enabling SilentScan for musculoskeletal (MSK) imaging and spine imaging in addition to a complete neuro exam that also includes Diffusion Weighted Imaging (DWI). The SIGNA Pioneer also features technology called Total Digital Imaging (TDI) enabling improved image quality and increasing signal to noise ratio (SNR) by up to 25 percent. TDI is composed of Direct Digital Interface (DDI), Digital Surround Technology (DST) and Digital Micro Switching (DMS). "At GE Healthcare, we design products to address clinicians' needs. Improved patient experience and productivity are essential now in healthcare. With SIGNA Pioneer, we set out to design a system with innovative solutions to help our customers and their patients. We are proud to introduce MAGiC that allows generation of six different contrasts in a single scan that's a major step forward in productivity. And SilentScan is setting the trend in the industry for a new level of patient experience; this enhanced SilentScan package will extend the comfort patients experience now beyond just neuro scans,"said Mr Eric Stahre, president and chief executive officer of GE Healthcare MR.   SIGNA Pioneer and MAGiC both are 510(k) pending at FDA.   ]]> https://biospectrumindia.com/news/97/6193/toshiba-launches-an-all-new-infinix-4dct.html https://biospectrumindia.com/news/97/6193/toshiba-launches-an-all-new-infinix-4dct.html Mon, 01 Dec 2014 13:09:21 +0530 Toshiba America Medical Systems, launches an all-new Infinix 4DCT that maximizes the full potential of IR and CT systems to deliver real-time CT images during interventions instead of CT-like images. The system significantly improves workflow with its SUREGuidance technology that allows for seamless and automatic transition between modalities. It is also capable of saving hours by allowing clinicians to perform CT and interventional procedures within the same room and verify treatment success immediately after procedures. The system improves workflow of oncology and cardiac procedures. It provides interventionalists with CT images of liver tumors and produces more precise views of the heart and stent placements. Clinicians can also adjust the procedure with real-time studies instead of relying on CT images taken at an earlier time. "Given the choice, most physicians would want real-time CT images versus CT-like images during complex, minimally invasive procedures. With the Infinix 4DCT, physicians no longer have to settle; for the first time, they have a seamlessly integrated IR and CT product to improve patient care," said Mr David Sloop, director, X-ray vascular business unit, Toshiba.   ]]> https://biospectrumindia.com/news/97/5686/horizon-enters-into-an-agreement-with-adarza-biosystems.html https://biospectrumindia.com/news/97/5686/horizon-enters-into-an-agreement-with-adarza-biosystems.html Mon, 01 Dec 2014 13:07:20 +0530 Horizon Discovery Group and Adarza BioSystems have announced that they have entered into an exclusive licensing and supply agreement. The agreement gives Horizon exclusive rights to supply services for Adarza's breakthrough multiplex immunoassay technology, Arrayed Imaging Reflectometry (AIR). The technology offers a powerful tool for stratification of patients and samples based on very small blood volumes, an increasingly vital step in the development of personalized medicines. As per the agreement, Horizon customers will be able to access leading protein biomarker discovery and validation capabilities alongside the broad menu of technology enabled services already available including; in vitro and in vivo gene-editing, phenotypic cell-based assay development, target identification and validation, chemical and biological agent screening, and high throughput drug combination screening. Dr Darrin M Disley, CEO, Horizon Discovery Group, said, "The ability to stratify populations that respond to drugs with the aid of blood-based biomarkers is becoming a critical part of developing better and more efficacious therapies. Horizon is committed to remaining at the forefront of high value technological advances that address our customers' research needs. The addition of AIR technology to our offering supports our growth strategy and is highly complementary to our current portfolio." Dr Preston Keller, vice president of business development at Adarza BioSystems said, "We are delighted to be working with one of the world's fastest-growing lifescience companies dedicated to driving forward the fields of gene editing and translational genomics. The agreement with Horizon validates Adarza's disruptive technology platform and allows us to leverage Horizon's world class sales and marketing network to bring the technology to market sooner and much more broadly than we could alone."   ]]> https://biospectrumindia.com/news/97/5029/perkinelmer-to-acquire-perten-instruments.html https://biospectrumindia.com/news/97/5029/perkinelmer-to-acquire-perten-instruments.html Thu, 27 Nov 2014 09:52:00 +0530 PerkinElmer has announced that it has entered into a definitive agreement to acquire Perten Instruments Group AB. Perten is a leading global supplier of advanced analytical instruments for quality control of food, grain, flour and feed. "The combination of Perten's unique capabilities with PerkinElmer's portfolio of innovative analytical instruments will enable us to further penetrate the multi-billion dollar global food testing market, including longer-term opportunities in higher growth regions such as China," said Mr Jon DiVincenzo, president, environmental health, PerkinElmer. He added, "PerkinElmer will now be firmly positioned to help customers address rigorous regulations for food quality control, import/export product testing, and the need to preserve the integrity of global supply chains." By adding Perten's analysis platforms, along with its leading food quality calibration database, PerkinElmer will build upon its broad offerings for food safety and quality testing throughout the development and manufacturing processes. The net purchase price of the transaction is approximately $266 million and is subject to customary closing conditions. The transaction is currently anticipated to close in December 2014.   ]]> https://biospectrumindia.com/news/97/6138/covidiens-fortrex-pta-balloon-receives-fda-510k-clearance.html https://biospectrumindia.com/news/97/6138/covidiens-fortrex-pta-balloon-receives-fda-510k-clearance.html Tue, 25 Nov 2014 12:42:06 +0530 Covidien has announced that it has recieved the US Food and Drug Administration 510(k) clearance for its Fortrex over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter. The Fortrex 0.035" OTW PTA balloon catheter, the next-generation high pressure solution to maintain arteriovenous (AV) access-is also intended for use in the peripheral vascular system.  The Fortrex PTA balloon provides physicians with a high pressure solution to crack the short, fibrous lesions that can block AV access. "Covidien is committed to being the clear first choice for physicians by delivering new, innovative technologies that help improve patient lives," said Mr Brian Verrier, president, vascular therapies, Covidien. He added, "The FDA clearance of the Fortrex PTA balloon builds on our existing PTA portfolio, providing clinicians with access to an advanced solution to improve AV access in patients being treated with hemodialysis."   ]]> https://biospectrumindia.com/features/97/8260/biotech-drugs-to-drive-indias-cold-chain-supply-market.html https://biospectrumindia.com/features/97/8260/biotech-drugs-to-drive-indias-cold-chain-supply-market.html Tue, 25 Nov 2014 10:49:00 +0530 The Industry India's integrated cold chain industry is composed of a combination of surface storage and refrigerated transport, growing at a CAGR of ~20 percent in the last three years. The Indian cold chain market is estimated to be worth $8 billion and is expected to touch $13 billion by 2018. Out of the $8 billion, less than $2 billion is shared by the biotech and pharmaceutical industry. Currently India roughly has about 6,300 cold storage facilities. Under the 12th Five Year Plan (2012-2017), the Department of Pharmaceuticals has asked for the assistance worth Rs 50 crore ($9.2 million) for setting up cold chain facilities across India. The Trends   The Indian cold chain market is dominated by private players and is highly fragmented in which about 3500 plus players are present. It is anticipated that cold chain market in India will get more organized with the entry of large private players in this arena. Globally, the focus now has shifted from increasing the production to better storage and transportation of goods. Cold chain now has become an integral part of the supply chain management for the storage and transportation of temperature sensitive goods. Utilization of cold chain logistics includes both the cold storages as well as refrigerated transportation and is used to increase the shelf life of food produce and other goods. Talking about emerging opportunities in the cold chain supply market, Prof. Anju Bharti, Maharaja Agrasen Institute of Management Studies, who has conducted a research study on the industry said, "Vaccines require the support of temperature controlled environment right from the point of their initial stage of production to their final distribution. This indicates the unexplored potential for both domestic as well as the international players which are present in the cold chain management system." Currently the market value for temperature controlled vehicles which are deployed for the transportation of pharmaceutical products is more than $3.8 million, which is likely to reach at around $17.1 million in the next five years. Entry of organized players, consolidation and cooperation between the organized and unorganized players, and increasing focus on quality and efficiency are seen as emerging trends said Mr Rajesh Agarwal, â€?director, Crystal Logistic Cool Chain.   The Challenges Numerous interruptions in the supply chain result in temperature-sensitive drugs remaining too long in the open-air loading dock and can result in the loss of drugs worth millions. Lack of sensitivity at the driver's level, poor infrastructure and various requirements at each state border coupled with no-entry restriction in most metros makes the refrigeration equipment stress when ideally not required, laments Mr Agarwal. "The existing facilities are outdated and poorly maintained. Lack of awareness and availability of technically qualified people to support efficient operations, lack of pre-cooling and storage facilities, dearth of refrigerated carriers, fragmented supply chains, poor scarce application of latest tools and technologies are major impediments," expressed Prof. Bharti. According to Prof. Bharti, construction of cold storages requires high-tech engineering services, whereas in India currently, cold storages are being constructed and operated by people who do not have any formal education in engineering and design.   "Across the country, there is no standardization in construction and equipment of the cold storages. The practices are rather localized and based upon erroneous concepts of heat transfer and principles of cold storages resulting in substantial extra spending in construction and regular loss of energy," she opined. Lack of electricity, power supply and other supporting infrastructure are a major challenge in setting up cold chain facilities. The creation of a cold chain infrastructure is a capital-intensive project, which requires a substantial amount of investment. "The investment risk is too large to be borne by any single player because of the low utilization of capacity in the initial phase," Prof. Bharti stated. State initiatives are adopting the public-private partnership (PPP) model. For instance, Karnataka has set up cold storage facilities by partnering with Karnataka State Agricultural Produce Processing and Export Corporation Limited (KAPPEC) and Ken Agritech in food sector. Warehousing projects usually get delayed or do not get commissioned due to land acquisition issues and regulatory clearances. Here the PPP model can play a significant role in easing the whole process.   Attracting Investments Indian laws already allow foreign direct investments (FDI) in cold chain infrastructure to the extent of 100 percent. "There has been no interest in foreign direct investments in building cold storage infrastructure. Experts claim that cold storage infrastructure will become economically viable only when there is strong and contractually binding demand from organized retail," Prof. Bharti said. Venture capitalists and private equity funds are excited about this space especially after the run that was witnessed on Snowman Logistics. In recent years, India's domestic cold chain industry has undergone both consolidation as well as expansion of capacity as with companies like Gati, Dev Bhumi, MJ Logistics and Crystal. There has also been an increase in the presence of international companies in India's cold chain industry such as Kuehne+Nagel and Gateway Distriparks.   Mr Agarwal said that there is a demand-supply mismatch, and thus competition is not intense in this industry. "Everyone coexists in the system. However there is a price war for the pharma and biotech customers as margins from this sector is high," he added. The Opportunities Although the recent move on allowing FDI for cold chain industry has received a cold response, experts believe that the industry will grow significantly as multi brand retail is no longer a distant dream. "The foreign companies will vie for a share in this market. Cutting edge technology and right partnership will help the companies create a position for themselves in this market," predicted Prof. Bharti. Organized warehousing companies are based in metros. However, the unorganized are present in tier III and IV cities. "An interesting point to note here is that 41 percent of cold chain warehouse capacity is in Uttar Pradesh," noted Mr Agarwal. In August 2014, Menzies Aviation Bobba, which operates cargo terminal at Kempegowda International Airport (KIAL) in Bangalore opened an exclusive 'Pharma Cold Zone' for handling pharmaceutical products.   The Mumbai International Airport (MIAL) has already installed four new cold rooms for pharma cargos, and has trained handling staff to ensure adherence to standard operating procedures. Organization of Pharmaceutical Producers of India (OPPI) has tied up with Delhi International Airport (DIAL) to overhaul and add to the existing cold chain facility. Real time temperature monitoring on a mobile phone is the latest technological advancement made, and this was a biggest concern of those in this space. "For now, implementation of Goods and Services Tax (GST) should be what the government of India should focus on. Infrastructure will take time and we see the government moving in the right direction," said Mr Rajesh optimistically. Major Players Amar Cold Storage  Brahmanand Himghar  ColdEx  ColdStar Logistics Crystal Logistics Cool Chain Dev Bhumi  Gateway Distriparks FHEL Fresh and Healthy Enterprises  Future Supply Chain Solutions  Gati Gubba Cold Storage  Kelvin  MJ Logistic Services OOCL Logistics India  Radhakrishna Foodland  Snowman Logistics TCI XPS Cold Chain ]]> https://biospectrumindia.com/news/97/5618/thermo-fisher-inaugurates-new-proteomics-center.html https://biospectrumindia.com/news/97/5618/thermo-fisher-inaugurates-new-proteomics-center.html Mon, 24 Nov 2014 12:48:04 +0530 Thermo Fisher Scientific has announced the opening of its new proteomics center in Bangalore. The new facility would enable customers to experience innovative technologies used in proteomics research, including the Thermo Scientific Orbitrap high resolution mass spectrometer platform. The proteomics center will also showcase Thermo Fisher's advanced analytical technologies such as high performance liquid chromatography (HPLC), ion chromatography (IC), gas chromatography-mass spectrometry (GC-MS), inductively coupled plasma mass spectrometry (ICP-MS), UV-visible spectrometry and Fourier transform infrared spectroscopy (FTIR). The facility was inaugurated by Mr Syed Jafry, senior vice president, APAC and emerging markets. The facility would provide the customers with a try and buy experience by conducting training workshops to help users refine their understanding on how to use Thermo Fisher's instruments and software in their unique laboratory workflows. Mr Jafry said, "We commissioned our Bangalore Customer Experience Center in June with unique genomics and molecular biology capabilities. This lab will provide an entirely new experience for our customers working on proteomics." "We are pleased to announce the opening of this new customer experience center," said Mr Amit Chopra, managing director and VP/GM for Thermo Fisher Scientific, India, "Along with innovative technology, we are committed to offering customized technical support to our customers working in proteomics and genomics including application and method development, method transfer, user training, onsite and offsite troubleshooting and validations." Dr Kapil Khullar, director of chromatography and mass spectrometry for Thermo Fisher in India, said, "This center will allow us to partner with our customers to develop solutions for India's pressing needs in the areas of healthcare, food security and safety." ]]> https://biospectrumindia.com/news/97/4820/iit-b-scientists-develop-special-membrane-that-cuts-dialysis-cost-time-by-half.html https://biospectrumindia.com/news/97/4820/iit-b-scientists-develop-special-membrane-that-cuts-dialysis-cost-time-by-half.html Fri, 21 Nov 2014 15:17:19 +0530 Singapore: Scientists at the Indian Institute of Technology- Bombay, India have developed a unique membrane that can effectively reduce dialysis time and cut costs to almost 50 percent. The technology is also thought to spur the development of wearable dialyzers. An AIIMS study highlighted that 90 percent of kidney patients in India die as they cannot afford the huge cost for a dialysis. The students at IIT-B's chemical engineering department is confident that the current scenario can change with their unique innovation. The hollow-fiber membrane developed by them has completed laboratory tests and awaits pre-clinical trials. The product has also procured an Indian patent and also an indigenous, low-cost pilot plant for production of these membranes has been functioning for the last two years. Mr Jayesh Bellare, who leads the IIT team, said, "This new membrane promises faster, efficient dialysis with less side effects at a significantly lower cost." The membrane developed by the IIT is a key component of the filter and removes impurities from the blood during hemodialysis thus improving performance in terms of separation and bio compatibility. It also permits faster treatment, lesser side reactions and could spur the innovation of novel devices such like portable or wearable dialyzers. ]]> https://biospectrumindia.com/news/97/5100/agilent-eppendorf-millipore-others-honored.html https://biospectrumindia.com/news/97/5100/agilent-eppendorf-millipore-others-honored.html Fri, 21 Nov 2014 14:19:00 +0530 The awards were presented by BioInformatics LLC, the premier market research and advisory firm serving the life science industry.  The event was attended by industry executives and product and marketing professionals from 41 life science companiesUsing industry best-practices market research methodologies, almost 6,000 scientists were surveyed to reveal preferred suppliers in 28 product, communications, and support categories. These scientists were drawn from BioInformatics LLC's online panel of scientists, The Science Advisory Board. From the data collected, BioInformatics LLC analysts calculated an overall score for each nominated company based on the number of nominations received, as well as key measurements of customer satisfaction and loyalty. "The vision and foresight of the companies we honored last night have made possible many of the scientific advances of the past decade," said Ms Jennifer Cotteleer, CEO of BioInformatics LLC. "Life science tools companies are the foundation upon which biological research and drug discovery rest and we are proud to support them in understanding the needs of their scientific customers."   The Winners of the prestigious 2014 Life Science Industry Awards® are: Abcam Best Use of Digital Media Agilent TechnologiesBest High Throughput Screening & Analysis Systems Becton, Dickinson & Co. Best Cell Analysis Instruments (Flow Cytometer-Based)Best Technical SupportBest Workflow Solutions - Cell-Based ResearchMost Memorable Advertising Bio-Rad Laboratories Best Protein Expression & Analysis ProductsBest Workflow Solutions - Genomics Carl ZeissBest Cell Biology Instruments (Microscope-Based)Breakthrough Product - Neuroscience Research Cell Signaling TechnologyBest AntibodiesMost Useful Website EMD/Merck Millipore"Greenest" Life Science Company EppendorfBest General Lab Equipment GE Healthcare Life Sciences Best Instrumentation for Protein Analysis & PurificationBest Protein Purification & Separation Products IlluminaBest High Throughput Sequencing Platform Life Technologies (Thermo Fisher Scientific)Best Cell Biology ProductsBest Cell Culture Media & ReagentsBest Genomics Analysis Kits & ReagentsBest Instrumentation for Genomic Analysis New England BiolabsBest Molecular Biology Products QIAGEN Best Nucleic Acid Purification & Separation ProductsMost Helpful Sales Force Seahorse BioscienceCompany to Watch in 2015Sigma-AldrichBest Customer Service Thermo Fisher ScientificBest Workflow Solutions - Proteomics2014 Market Leadership Award ]]> https://biospectrumindia.com/news/97/5958/sequenta-illumina-to-develop-in-vitro-diagnostic-kit.html https://biospectrumindia.com/news/97/5958/sequenta-illumina-to-develop-in-vitro-diagnostic-kit.html Fri, 21 Nov 2014 10:54:00 +0530 Sequenta has announced it has entered into an agreement with Illumina to commercialise an in vitro diagnostic (IVD) kit that will enable clinical laboratories to utilise Sequenta's next-generation sequencing (NGS)-based minimal residual disease (MRD) detection and quantification technology. "It is exciting to see how Illumina is enabling new diagnostic tests that may improve patient care. This partnership is consistent with our strategy to support third party IVD products on our sequencing platform," said Mr Nicholas J Naclerio, senior vice president, corporate and venture development, and general manager, enterprise informatics, Illumina. The company also announced that Illumina participated in Sequenta's recent Series D funding round. "Partnering with Illumina to develop an IVD kit will ultimately enable more doctors to use the prognostic power of Sequenta's MRD detection and quantification technology in caring for their patients," said Mr Tom Willis, CEO, Sequenta. He added, "The availability of an IVD kit that has gone through FDA review will solidify Sequenta's position as the diagnostic partner of choice for pharmaceutical and lifescience companies incorporating MRD measurement into clinical trials of blood cancer medicines."   ]]> https://biospectrumindia.com/news/97/5001/beckman-coulter-supports-the-one-study.html https://biospectrumindia.com/news/97/5001/beckman-coulter-supports-the-one-study.html Thu, 20 Nov 2014 16:23:24 +0530 Beckman Coulter Life Sciences is participating in the ONE Study, an international collaboration of scientists across Europe and the USA. This cooperative project aims at developing and tracking various immunoregulatory cell products in organ transplantation recipients. Beckman Coulter is contributing its flow cytometry expertise in cell therapy and diagnostic technologies to support the study's specific translational research into organ transplantation and immune deficiency diseases such as HIV. Prof. Edward Geissler, the founder of the ONE Study and head of Experimental Surgery at the University Hospital in Regensburg, Germany, said, "Collaborating with Beckman Coulter scientists has furthered our ability to conduct clinical research studies in the field of organ transplantation. In case of the ONE Study, this will permit us to more accurately assess the effects of various different cell therapies as potential advanced, therapeutic products." Mr Mario Koksch, VP and general manager of Beckman Coulter's cytometry business unit, explained, "As a company we are increasingly working with clinical research scientists to enable them to standardize and streamline workflow for high content flow cytometry. This is particularly valuable for translational research being carried out across multiple sites where results must be reproducible. Our contribution to the ONE Study is already facilitating the consistent identification of cellular sub-populations of the human immune systems, which is vital to immunodeficiency research."   ]]> https://biospectrumindia.com/news/97/4985/covidien-recieves-ce-mark-for-patient-monitoring-system.html https://biospectrumindia.com/news/97/4985/covidien-recieves-ce-mark-for-patient-monitoring-system.html Thu, 20 Nov 2014 14:24:42 +0530 Covidien has announced that it has been given a CE Mark approval for its Nellcor Bedside SpO2 Patient Monitoring System, PM100N. The system currently is available in the European Economic Area (EEA), Australia, and New Zealand. It complies with standards for medical electrical equipment used in the home health care environment. The new system provides continuous monitoring of blood oxygenation (SpO2) and pulse rate to help clinicians detect and respond to dangerous respiratory events sooner, along with patient trend data to allow clinicians to evaluate a patient's clinical course. With Covidien-exclusive digital signal processing, the PM100N offers industry-leading speed and accuracy, and reliable pulse oximetry readings-even during low patient perfusion, motion and other forms of signal interference. "At Covidien, we are dedicated to improving patient care and safety, not only in the hospital, but also in home health care," said Mr Matt Anderson, vice president and general manager, Patient Monitoring, Respiratory and Monitoring Solutions, Covidien. The pulse oximetry system was designed with features to help improve patient safety. It incorporates SatSeconds Alarm Management technology-available only on Covidien patient monitors to help distinguish between serious and minor events, reducing clinically insignificant desaturation alarms. "Just because a patient is not in the hospital setting does not mean he or she no longer needs on-going care. The availability of solutions to enable safe, quality care for patients in all settings, including the home, is something we are focused on at Covidien. This new system includes all of the leading Nellcor technology that clinicians have trusted for more than 30 years, with additional features that make it well suited to the home health care environment," said Dr Scott Kelley, chief medical officer, Respiratory and Monitoring Solutions, Covidien.   ]]> https://biospectrumindia.com/news/97/3886/google-introduces-genomics-cloud-platform.html https://biospectrumindia.com/news/97/3886/google-introduces-genomics-cloud-platform.html Thu, 20 Nov 2014 14:22:22 +0530 Google has launched a cloud computing platform, 'Genomics cloud platform' to keep, share, and analyze genomic data. "We saw biologists moving from studying one genome at a time to studying millions. The opportunity is how to apply breakthroughs in data technology to help with this transition," said Mr David Glazer, the Google software engineer who led the effort, in a statement to MIT Technology Review. 3,500 genomes have been uploaded to Google's servers so far.  Reportedly, the programming interface of Google Genomics allows users to focus on science rather than tech details such as servers and file formats; store genomic data securely so that private data remains private, while public data is available to the community anywhere; and process as much data as they need, all at once.   ]]> https://biospectrumindia.com/news/97/5535/proteus-digital-health-launches-a-wearable-for-athletes.html https://biospectrumindia.com/news/97/5535/proteus-digital-health-launches-a-wearable-for-athletes.html Thu, 20 Nov 2014 13:10:29 +0530 Proteus digital health has launched its new product, Proteus Recover for athletes as a kind of a surveillance device to record physiologic information like heart rate, respiration rate, skin temperature, activity, body posture, and other associated metrics. According to the company, "Proteus Recover is the only system that supports 24-hour optimization of athlete recovery and daily physiologic load. Understanding an athlete's entire day and night will provide information to drive simple yet impactful changes, maximizing athletic performance." The system purports to measure five core metrics: A recovery score, deduced from heart rate variability during sleep; sleep duration, as well as start and stop times; resting and average heart rate; energy expenditure in kilocalories. "The Recover product and associated wearable sensors is a consumer product and not a medical device. The product is not intended to diagnose, treat, cure or prevent any disease," the company cautioned.   ]]> https://biospectrumindia.com/news/97/5097/kobo-founders-raise-4m-for-their-new-mobile-health-startup.html https://biospectrumindia.com/news/97/5097/kobo-founders-raise-4m-for-their-new-mobile-health-startup.html Wed, 19 Nov 2014 15:03:13 +0530 Kobo, an eReader device company have raised $4 million in seed funding for their next venture, Toronto-based mobile health startup, League. The seed round was led by OMERS Ventures with participation from Foundation Capital, Real Ventures and Infinite Potential Group. "Healthcare costs are massive and growing at an unsustainable rate. While nearly half of those costs are preventable, next to nothing is spent on prevention this needs to change. The future of health is preventative, and it's about the consumer," said Mr Michael Serbinis, CEO and founder, League in a statement. The new startup is developing a digital health platform focused on preventative health and is set to launch in early 2015. According to the company, "League makes it easy to discover, schedule, and pay for services while staying conveniently connected. The platform will store health information including data from wearables and popular health applications putting members in control of their information and giving them the ability to safely and securely share their data with their League."   ]]> https://biospectrumindia.com/news/97/4704/dna-medicine-institute-wins-nokia-sensing-xchallenge.html https://biospectrumindia.com/news/97/4704/dna-medicine-institute-wins-nokia-sensing-xchallenge.html Tue, 18 Nov 2014 15:46:55 +0530 XPRIZE has awarded DMI (DNA Medicine Institute) the $525,000 Grand Prize in the Nokia Sensing XChallenge, a competition to catalyse breakthrough medical sensing technologies that will ultimately enable faster diagnoses and easier personal health monitoring. The Cambridge, Massachusetts-based medical technology incubator and laboratory led by founder and CEO Mr Eugene Y Chan, has developed the Reusable Handheld Electrolyte and Lab Technology for Humans ("rHEALTH") system. It is a compact portable device that can run hundreds of clinical lab tests on a single drop of blood,  and can detect a cold, a flu and also a more serious ailment such as pneumonia or even Ebola that requires more urgent medical care. "We are truly honored to be recognised as the Grand Prize winner in the Nokia Sensing XCHALLENGE. To be selected from such an impressive group of worthy competitors is extremely humbling. Our hope is that the rHEALTH system, once commercialized, will enable consumers to monitor their own health while on-the-go in a more efficient manner and alert them of more serious medical concerns almost immediately," said Dr Chan. "Our expert judging panel reviewed a very exciting group of sensing technologies, all with the potential to address a wide array of diagnostic and personal health needs," said Dr Peter H Diamandis, chairman and CEO, XPRIZE. He added, "DMI's rHEALTH system embodies the original goal of the Nokia Sensing XCHALLENGE to advance sensor technology in a way that will enable faster diagnoses and easier, more sophisticated personal health monitoring." DMI was selected from 11 finalist teams and received the highest combined score in accuracy, consistency, demonstration quality, technical innovation, human factors, market opportunity, originality, and user experience.    ]]> https://biospectrumindia.com/news/97/3501/telemedicine-firm-gets-a-big-push-from-xerox.html https://biospectrumindia.com/news/97/3501/telemedicine-firm-gets-a-big-push-from-xerox.html Mon, 17 Nov 2014 12:29:19 +0530 Technology giant Xerox has made a strategic investment in telemedicine company HealthSpot, a pioneer in patient and provider-driven healthcare technology. Through proprietary cloud-based telemedicine software, the HealthSpot platform allows patients to interact with nationally recognized doctors. The average visit to one of HealthSpot's fully enclosed, 40-square foot kiosks takes 15 minutes, offering patients convenient, timely access to doctors, specialists, and prescriptions. The capital investment from Xerox means HealthSpot can rapidly scale deployment of its kiosks and access Xerox's relationships across the healthcare industry. Over the next five years, HealthSpot plans to deploy kiosks to retail pharmacies, large employers, long-term care centers and emergency departments throughout the nation. "HealthSpot is at the center of healthcare's shift to a patient-centered model of care, and our investment in the company demonstrates Xerox's commitment to transforming traditional healthcare into a high-value delivery system for patients, providers and payers," said Mr Connie Harvey, chief operating officer of Commercial Healthcare for Xerox. He added, "By combining the HealthSpot platform with our powerful brand and more than 40 years of healthcare experience, we are helping patients unlock affordable access to care while positioning Xerox to play a significant role in the future of healthcare." Xerox is also partnering with HealthSpot to combine its software platform with Xerox's business process services expertise. The kiosk will use Xerox's IT infrastructure for appointment booking, as an interface to electronic health records and for insurance coordination.   ]]> https://biospectrumindia.com/features/97/4438/can-predictive-genomics-take-off-in-india.html https://biospectrumindia.com/features/97/4438/can-predictive-genomics-take-off-in-india.html Mon, 17 Nov 2014 10:00:00 +0530 "The market value for predictive genomics is considered to be about Rs 100 crore," says Dr Raja Mugasimangalam, founder and CEO, Genotypic Technology. Also, an approximate estimate can be drawn based on the US market size which is predicted to grow to as much as $452 billion by 2015. This includes not only the healthcare and pharma markets but also the nutrition and wellness market opportunities that use predictive genomics. Current research in predictive genomics in India is primarily about identifying specific genetic variations and their association to diseases. However, what is needed is to follow up on these initial studies to validate the targets by doing follow-up studies. It is important to find out if the association is indeed clinically relevant. One of the applications of predictive genomics is in the field of personalized medicine where each individual is treated based on his or her unique genetic makeup. "This will have an impact on how the biotech, pharma and healthcare industries operate. Raw genomic data and its interpretations will eventually come to be seen as an indispensable part of health and wellness," said Dr Saleem Mohammed, founder and CEO, Xcode Life Sciences.   For example, several individuals metabolize different drugs in various fashion. Widely prescribed drugs like Clopidogrel, Warfarin and Statins have different efficacies in different individuals based on their genetic makeup. If this is determined early, then the number of dosages can be altered to prevent complications. According to Dr Kalyanasundaram Subramanian, CSO, Strand Life Sciences, for pharma and biotech companies the opportunity here is to develop drugs paired with companion diagnostics that will clearly help identify responders to their treatments. Over the last couple of years, Indian start-up landscape has seen a handful of genomic companies that have begun to address the initial needs of the Indian market. Each of these tend to offer a range of services that include sample collection, sequencing, primary analysis and finding variants in a dataset. Of these activities only 'variant calling' falls in the purview of predictive genomics. However the real potential of predictive genomics lies in the interpretation of data. Metaome is building products and technologies to address this need. A lot of biomarker panel based genetic testing companies have evolved rapidly in India in the recent past. The use of genomics tool at clinical level has already started in India. However, according to experts, the future lies in whole Exome or whole genome sequencing (WGS).   Currently, there are no companies in India making Next Generation Sequencing (NGS) instruments. They are imported from the US. There are three major players in NGS namely Illumina, Life Technologies and Pacific Biosciences. Among the sequencing providers Illumina has almost 90 percent market share, owing to their superior data quality and throughput. Since, data quality is the most important factor, especially for the diagnostic applications, most of the service providers choose Illumina's platform. The existing major challenge now is the lack of awareness among the medical community and general public. "Another challenge is the availability of genomic data. We have had to rely on studies based on global populations that have a different genetic makeup compared to the Indian population. Importantly, both these challenges present opportunities to first movers to take predictive genomics to the next level in India," opined Dr Saleem. While the cost of sequencing a genome has come down rapidly in the past few years, the technology is still expensive to use. But this situation is changing fast as costs are being lowered at a faster than exponential rate, and will no longer be as big a barrier as it is currently. Also, the industry suffers with the issue of 'no' regulation. "This is an ethically fraught situation since a genetic diagnosis potentially affects the whole family and hence needs to be performed in manner that is considered ethical, and with the consumer and clinician clearly understanding the parameters of the test and the risks that various types of diagnosis may provide," he stated.   On the pharma side, these tests have the potential to make drugs more applicable by being able to provide them to patients who are most likely to benefit. The other challenges comes from a poor understanding of the Indian genome. Indian genomes are poorly represented in worldwide consortia attempts such as the 'HapMap' and the '1000 genomes project'. There is a need for government agencies and private players to develop strategies to share data and create an Indian genome. The social and ethical implications of genomic testing pose a major challenge. Confusing regulatory guidelines or the absence of any guidelines in India is a major threat. Not to mention, the lack of infrastructure, and the consequent cost of tests, makes it difficult for this technology to penetrate the existing disease testing market. Mr Sam Santhosh, CEO, SciGenom, justifies by saying, "Cost is a major bottleneck. The technology required to bring predictive medicine to the bedside today is primarily imported from vendors in the US and Europe." India is yet to realize the significance of predictive genomics. "The size of our population makes it such that we can derive a lot of valuable information from large scale genomic studies. The potential for such information to have an impact on public health is also much more," predicted Dr Saleem.   Predictive Genomics industry is changing at the breath taking pace globally but India is in its early stages, and people have started accepting it recently. "In India the major focus is on sequence analytic methods, whole exome analysis, integration of systems biology modeling, large scale mutational analysis, Evolutionary connection studies to Genetic disorders," opined Dr Amit Kumar, CEO and CSO, BioAxis DNA Research Centre. While genomics industry in the US has an economic output of $65 billion per annum, Indian genomic industry is less than one-fourth the amount. Investments are huge in the US, and the government is also actively participating in boosting this industry with clear guidelines. ]]> https://biospectrumindia.com/news/97/5157/prof-shubha-tole-wins-infosys-prize-2014-in-life-sciences.html https://biospectrumindia.com/news/97/5157/prof-shubha-tole-wins-infosys-prize-2014-in-life-sciences.html Thu, 13 Nov 2014 17:08:03 +0530 This year, in the Life Sciences category, the award has been given to Prof Shubha Tole, who is an associate professor and principal investigator in the department of biological sciences, at the Tata Institute of Fundamental Research (TIFR), in Mumbai. It was cited that she had made significant contributions in understanding how the brain structure and circuitry are formed in the embryo, leading to better understanding of human behavior, cognition and emotions. Now in its 6th year, the Infosys Prize is given to high caliber researchers for their impactful contribution in their respective fields. The prize consists of Rs 55 lakh, which is tax-free for winners receiving within India; a 22-karat medallion; and a citation certificate. The awarding ceremony will happen in Kolkata on January 5, 2015, and the awards will be presented by the Indian President, Shri Pranab Mukherjee.   The Infosys Science Foundation, erected in 2009, is funded by a corpus which stands at Rs 100 crore, contributed by the trustees and Infosys. In 2013, Dr Rajesh S Gokhale, director, CSIR-Institute of Genomics and Integrative Biology, won the award for his work in the field of lipid metabolism in M. tuberculosis The other 5 winners for 2014 include: Engineering and Computer ScienceProf Jayant HaritsaProfessor, Supercomputer Education and Research Centre (SERC) and Chair, Department of Computer Science and Automation (CSA), Indian Institute of Science (IISc), Bangalore, India Prof Jayant Haritsa has been awarded this prize for his contributions to the design and optimization of database engines. HumanitiesProf Shamnad BasheerFounder and Managing Trustee, Increasing Diversity by Increasing Access (IDIA), Bangalore and Founder - SpicyIP, India Prof Shamnad Basheer has been awarded this prize for his contributions to the analysis of a range of legal issues, including pharmaceutical patent injunctions and enforcement. Mathematical SciencesProf Madhu SudanPrincipal Researcher, Microsoft Research New England and Adjunct Professor, Electrical Engineering & Computer Science (EECS) department and Computer Science and Artificial Intelligence Laboratory (CSAIL), Massachusetts Institute of Technology (MIT) Prof Madhu Sudan has been awarded this prize for his seminal contributions to probabilistically checkable proofs and error-correcting codes. Physical SciencesDr Srivari ChandrasekharScientist G, Organic Chemistry Division, Council of Scientific and Industrial Research, Indian Institute of Chemical Technology (CSIR-IICT), Hyderabad, India Dr Srivari Chandrasekhar has been awarded this prize for his contributions in the general area of synthetic organic chemistry with a special focus on the synthesis of complex molecules from natural sources. Social SciencesProf Esther DufloAbdul Latif Jameel Professor of Poverty Alleviation and Development Economics, Department of Economics, Massachusetts Institute of Technology (MIT) and Founder & Director, Abdul Latif Jameel Poverty Action Lab (J-PAL), USA Prof Esther Duflo has been awarded this prize for her pioneering contributions to development economics, especially work related to countries such as India and Africa. ]]> https://biospectrumindia.com/news/97/3665/ge-healthcare-takeda-to-develop-drugs-for-liver-diseases.html https://biospectrumindia.com/news/97/3665/ge-healthcare-takeda-to-develop-drugs-for-liver-diseases.html Thu, 13 Nov 2014 12:44:00 +0530 GE Healthcare and Takeda Pharmaceutical announced that they have entered into an agreement for research and development in the field of hepatic fibrosis, a key factor in the diagnosis and treatment of liver diseases According to the terms of agreement, GE Healthcare will provide Takeda with its diagnostic imaging technology for use to generate a liver stiffness map as part of the research and development work Takeda is conducting on liver diseases. "It gives me great pleasure to have been able to build this alliance with GE Healthcare to develop therapeutic drugs to treat liver diseases. This alliance will assist efforts to develop new therapeutic options that ease the burden on the patient. Moving forward, we will continue to put the patient first and incorporate a wide range of innovations into the field of drug discovery," said Mr Tadataka Yamada, chief medical and scientific officer at Takeda. "It is extremely gratifying to me that, through this collaboration, our technologies will be of use in the development of treatments for the liver diseases that are of particular importance not just in Asia, but worldwide," said Mr Akihiko Kumagai, chairman of GE Healthcare Japan with overall responsibility for liver disease programs. He added, "We have been focusing efforts on developing technologies to help provide solutions for liver cancer. As one location in our global research and development network, Japan, whose strategy is to create solutions for an aging population, has been a driving force behind these efforts. "   ]]> https://biospectrumindia.com/news/97/3970/agilent-advances-ftir-microscopy-imaging.html https://biospectrumindia.com/news/97/3970/agilent-advances-ftir-microscopy-imaging.html Thu, 13 Nov 2014 10:44:00 +0530 Agilent Technologies has introduced significant enhancements to its Cary 610 and 620 Fourier transform infrared spectrometer (FTIR) microscopes. These groundbreaking FTIR microscopy systems offer the largest field of view at the highest spatial resolution in the shortest period of time. The instrument is designed for use in a wide range of applications, including biomedical, materials, polymers, food, forensics, pharmaceutical, and chemical. The Cary 610 is a single-point FTIR microscope, capable of single-point mapping, while the Cary 620 is a focal plane array (FPA) based imaging FTIR microscope. A Cary 610 can be easily upgraded to a Cary 620. "The Cary 620 FTIR imaging microscope's innovative, high-magnification optics provide the highest-resolution data quality, unsurpassed by any other FTIR system," said Mr Philip Binns, Agilent's vice president of spectroscopy products. He added, "This system brings the power of synchrotron FTIR imaging onto the laboratory bench. The enhancements we have made in both hardware and software provide our customers with capabilities to analyze samples that were never before possible, allowing them to advance their research, increase production capacity and reduce costs." The Cary 610/620 FTIR systems offer enhanced flexibility for busy laboratories. New IR high-magnification optics provide an additional 5x magnification without changing the objectives. Unsurpassed energy throughput and enhanced software ensure that a wider range of samples can be analyzed quickly and easily. The systems also comes with the largest choice of objectives, accessories and imaging options for more customized experiments.   ]]> https://biospectrumindia.com/news/97/4775/zeiss-presents-first-of-its-kind-sem.html https://biospectrumindia.com/news/97/4775/zeiss-presents-first-of-its-kind-sem.html Wed, 12 Nov 2014 13:16:00 +0530 ZEISS will present ZEISS MultiSEM 505, its new scanning electron microscope (SEM) at the Annual Neuroscience meeting. As the first SEM in the world, the system features 61 beams working in parallel, and offers an unrivaled capture speed of 1220 megapixels per second at a pixel size of 4 nm. This high acquisition speed is used for imaging neural tissue in brain research. It is designed for continual operation and fitted with the intuitive ZEN software.  ZEISS MultiSEM uses 61 beams simultaneously, making it possible to acquire 61 images in parallel. Thus large areas can now be imaged very quickly and acquisition times are reduced from years to weeks. The first users of this microscopes are the laboratories of Jeffrey Lichtman, Harvard University in Cambridge and Winfried Denk, Max Planck Institute of Neurobiology. Both are using microscopy to investigate structure and function of the brain.   ]]> https://biospectrumindia.com/news/97/3915/ab-sciex-launches-newer-version-of-adme-software.html https://biospectrumindia.com/news/97/3915/ab-sciex-launches-newer-version-of-adme-software.html Wed, 12 Nov 2014 12:43:01 +0530 AB SCIEX has introduced DiscoveryQuant 3.0 Software, a new version of its ADME software. It enables scientists to make better decisions about drug candidates faster, as the new software reduces tedious LC/MS method development time with a fast, robust, and reliable process that optimises methods for hundreds of small and/or large molecules. The new software expedites the method development process from existing database information, automates on-column optimisation, and easily analyses and processes multiple samples at the same time. Supported on all AB SCIEX MS platforms (TripleTOF, QTRAP, and Triple Quad systems) and with the ability to seamlessly communicate with MultiQuant 3.0 Software,it ensures success in high throughput drug discovery and development. "Discovery labs continue to search for ways to improve efficiency to address the demands of fast turn-around times required in the drug candidate screening process. Our goal is to offer best-in-class system solutions and DiscoveryQuant 3.0 software in combination with our LCMS platforms stays true to that, as it provides scientists with the ability to rapidly develop methods for all molecule types, in a high throughput environment," said Mr Joe Fox, senior director of pharma business at AB SCIEX. The software is available online for trial and purchase.   ]]> https://biospectrumindia.com/news/97/4748/jj-acquires-orsl-electrolyte-drink-brand.html https://biospectrumindia.com/news/97/4748/jj-acquires-orsl-electrolyte-drink-brand.html Wed, 12 Nov 2014 10:28:00 +0530 The financial terms of the transaction were not disclosed. ORSL is a fruit-based electrolyte drink in India, which is helpful for quick energy and electrolytes restoration during mild dehydration and general debility, often following cough and cold, pain, fever, and other digestive conditions. "India is a very important market for Johnson & Johnson, and we are pleased to add the ORSL brand to our portfolio of consumer healthcare brands in India. This acquisition will allow us to expand our consumer health care offerings in line with our vision of helping consumer's lead healthy vibrant lives," said Mr Thibaut Mongon, group chairman, Johnson and Johnson Family of Consumer Companies Asia Pacific. Under the agreement, Jagdale Industries will provide transition services in the area of manufacturing, detailing and distribution of ORSL. ]]> https://biospectrumindia.com/news/97/4073/ifpma-announces-its-new-president.html https://biospectrumindia.com/news/97/4073/ifpma-announces-its-new-president.html Tue, 11 Nov 2014 15:50:59 +0530 Mr Stefan Oschmann, CEO pharma and member of the executive board of Merck, was elected the President of IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) during 27th IFPMA Assembly. Previously, he was the vice president at IFPMA since 2012. He succeeds Mr John Lechleiter, chairman, president and CEO of the executive board of Eli Lilly. "I plan to focus my presidency on 'accelerating access' to quality health solutions for people in low and middle income countries to contribute to the sustainability challenge. Much progress has been achieved in expanding access to health in these countries but the call for 'accelerating access' demonstrates that there is still so much that needs to be done and only together can we make a lasting difference," said Mr Oschmann.     ]]> https://biospectrumindia.com/news/97/6611/agilent-introduces-1290-infinity-ii-lc-system-in-india.html https://biospectrumindia.com/news/97/6611/agilent-introduces-1290-infinity-ii-lc-system-in-india.html Tue, 11 Nov 2014 14:10:43 +0530 Keeping with its tradition of introducing new improved technology to meet the requirements in chromatography at regular intervals, the Agilent Technologies has introduced the 1290 Infinity II LC System, its new flagship instrument in the powerful 1200 Infinity Series LC portfolio. The system enables operators, scientists and laboratory managers to reach new levels of laboratory efficiency with the instrument's exceptional analytical quality, ease of use and ability to seamlessly integrate into any laboratory. The announcement of the launch was made at New Delhi on November 10, 2014. While interacting with the press, Dr Siva Kumar Pasupathi, country manager, Life Sciences, Diagnostics and Applied Markets (LDA), Agilent in India, said, "We have worked closely with a variety of customers to identify their most challenging liquid chromatography workflow issues and bottlenecks, and we are delighted to share this next-generation ultra-high-performance solution with all those seeking to maximize their day to day efficiency and productivity." As per the company, new system represents the next-generation UHPLC with the same levels of reliability and robustness users have come to expect from Agilent, along with unique capabilities to maximize efficiency in three important areas that includes analytical efficiency, instrument efficiency and laboratory efficiency. The 1290 Infinity II LC provides scientists with exceptional analytical data quality, chromatographic resolution/precision and broad dynamic range detection. Lowest carry-over provides uncompromised data for the most demanding analyses. The system is exceptionally easy to use and provides instrument operators with new levels of capabilities. Maximum flexibility to accommodate changing separation conditions reduces turnaround times. Unmatched throughput is enabled by highest sample capacity per bench space and fastest injection cycles. It can be seamlessly integrated into any existing laboratory. It enables smooth method transfer from any legacy equipment-a must for laboratory and department managers seeking to lower costs and increase returns on their investments. The 1290 Infinity II LC features eight new modules and a variety of powerful Agilent A-line accessories to further optimize chromatographic efficiency and laboratory workflow. Additionally, the OpenLAB Chromatography Data System enables effortless LC instrument control, fully traceable data management, convenient generation of results and comprehensive reporting capabilities. ]]> https://biospectrumindia.com/news/97/4996/it-expenditure-of-healthcare-providers-up-by-5-percent.html https://biospectrumindia.com/news/97/4996/it-expenditure-of-healthcare-providers-up-by-5-percent.html Tue, 11 Nov 2014 13:43:00 +0530 Healthcare providers in India are expected to spend $1.1 billion on IT products and services in 2014, an increase of 5 percent from last year, according to Gartner, an information technology research and advisory company. This includes spending by healthcare providers (including hospitals and hospital systems, as well as ambulatory services and physicians' practices) on internal services, software, IT services, data center, devices, and telecom services. IT Services,  which includes consulting, implementation, IT outsourcing and business process outsourcing, will be the largest overall spending category throughout the forecast period within the health care providers sector. It is expected to reach $300 million in 2014, up from $280 million in 2013 - with the consulting segment growing 10 percent. "India has a new government, and the Ministry of Health will closely examine ways to deliver cost effective healthcare across the country. Delivering wide access to healthcare in an affordable manner will be a top priority for the wider public healthcare system. The organised private healthcare sector will continue its expansion across Tier 2 and Tier 3 cities, as well as niche sectors like maternity and child health. We expect emphasis on eHealth, mobile health, telemedicine, public private partnership and leveraging innovative delivery models," said Mr Anurag Gupta, research director at Gartner.     ]]> https://biospectrumindia.com/news/97/5739/siro-clinpharm-opens-new-facility-in-hyderabad.html https://biospectrumindia.com/news/97/5739/siro-clinpharm-opens-new-facility-in-hyderabad.html Tue, 11 Nov 2014 13:42:06 +0530 SIRO Clinpharm announces the opening of its new office in Hyderabad, India.  "Hyderabad has always had a vibrant biopharmaceutical ecosystem and we believe that SIRO Clinpharm can actively contribute to the global industry with the expansion of our local operations. With our expanding footprint, we broaden our value proposition and bring a unique competitive advantage to the table," said Mr Partha Chatterjee, head, clinical research and clinical trial supplies management. "The clinical research industry has its niche, which requires specialised talent and Hyderabad, being a lifesciences hub, attracts highly qualified professionals from across the country. Our new office gives us access to this talent pool, which is imperative to ensure that we are providing our clients with world class services," said Dr Vatsal Shah, vice president and global head, medical writing, biometrics and pharmacovigilance. In addition to their wide operational presence across the globe, SIRO also has access to a large database of investigators and is one of the few CROs to have a dedicated feasibility team.  ]]> https://biospectrumindia.com/news/97/3476/new-ultracentrifuge-by-thermo-fisher-scientific.html https://biospectrumindia.com/news/97/3476/new-ultracentrifuge-by-thermo-fisher-scientific.html Mon, 10 Nov 2014 14:41:02 +0530 Thermo Fisher Scientific has announced the launch of its new product, 'Thermo Scientific Sorvall WX+' ultracentrifuge. The Sorvall WX+ ultracentrifuge offers up to 100,000 rpm performance in a small footprint to maximise space in the lab. It has a lightweight and fatigue-resistant Thermo Scientific Fiberlite carbon fiber rotors. It also comes with a self-locking rotor system that provides confidence that the rotor is automatically and securely locked. The new centrifuge also comes with a stat light bar, which allows users to personalise and monitor the status of the instrument from across the lab, and also reduces power usage by up to 50 percent when in idle mode, compared to previous model. It also features an intuitive color LCD touchscreen to keep programming simple and easy to navigate. it is designed to accommodate a multiple-user environment, the Sorvall WX+ ultracentrifuge monitors run data with optional log manager software that recalls past operating parameters with up to 5,120 cases of recorded histories to assist with GMP/GLP compliance. "In a shared laboratory setting, addressing the necessary application requirements for centrifugation can be difficult, especially with limited space. Our ultracentrifuges deliver exceptional performance and versatility for processing applications in a compact design," said Mr Philip Hutcherson, global product manager, superspeed and ultraspeed centrifuges, Thermo Fisher Scientific.     ]]> https://biospectrumindia.com/news/97/5055/toshibas-new-x-ray-system-receives-fda-approval.html https://biospectrumindia.com/news/97/5055/toshibas-new-x-ray-system-receives-fda-approval.html Fri, 07 Nov 2014 17:19:04 +0530 Toshiba America Medical Systems has announced that its Kalare R&F digital X-ray system with the dynamic flat panel detector (FPD) has received FDA clearance. The enclosed table design of the Kalare FPD R&F system may reduce scatter radiation by up to 95 percent, optimizing safety for patients and staff. Its 17" x 17" size provides quality images edge-to-edge without an increase in dosage. This design also helps reduce panning time for examinations requiring fluoroscopy, such as a barium swallow, and eliminates periphery image distortion, leading to higher image quality and better diagnoses. "Adding an FPD to the Kalare enables clinicians to obtain more information from the images faster, resulting in quicker, more accurate patient diagnoses. But beyond the clinical benefits, this technology offers these improvements in conjunction with a far safer environment for both patient and provider," said Mr David Sloop, director, X-ray vascular business unit, Toshiba.     ]]> https://biospectrumindia.com/news/97/4254/gvk-bio-acquires-vanta-bioscience.html https://biospectrumindia.com/news/97/4254/gvk-bio-acquires-vanta-bioscience.html Fri, 07 Nov 2014 12:54:33 +0530 Hyderabad-based GVK BIO said that it has signed a definitive agreement to acquire Chennai-based Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment contract research organization Commenting on the development, Mr Manni Kantipudi, CEO, GVK BIO said, "The acquisition is in line with our business strategy of being an integrated drug discovery services provider for our customers. We are constantly investing in upgrading our capabilities to provide world-class R&D services. Vanta Bioscience further advances our position as we expand our service offering in GLP (good laboratory practice) toxicology." The financial terms of the agreement weren't disclosed. Some media reports suggest that the deal is around $5 million.   ]]> https://biospectrumindia.com/news/97/5229/medidata-and-ppd-partner-to-offer-new-approach-to-risk-based-monitoring.html https://biospectrumindia.com/news/97/5229/medidata-and-ppd-partner-to-offer-new-approach-to-risk-based-monitoring.html Thu, 06 Nov 2014 17:23:17 +0530 Medidata and Pharmaceutical Product Development(PPD) has announced they are expanding their partnership to provide the lifescience industry with a more comprehensive approach to risk-based monitoring (RBM) aimed at conducting drug development more intelligently, more quickly and more cost-effectively. "We are very excited about extending our partnership with a world-class CRO like PPD. We share a common vision of transforming drug development through the power of technology and the intelligent use of data for the benefit of our customers," said Mr Glen de Vries, Medidata's president. This effort combines processes to increase data sampling and tracking of source document verification (SDV) through Medidata TSDV (targeted source document verification) with site health assessments and risk evaluation through PPD's adaptive and intelligent monitoring. This new endeavor will afford clinical research associates increased scrutiny of targeted endpoints that pose the greatest areas of risk in studies. Through this new arrangement, the companies will track specific SDV requirements and compliance directly within electronic data capture systems and will have greater opportunity to focus remote monitoring on targeted critical data points. According to Ms Lori Eberhardt, PPD's vice president of remote site management and remote monitoring, "Medidata's TSDV solution closely complements PPD's adaptive and intelligent approach to risk-based monitoring. Partnering with Medidata to enhance our RBM strategy is another example of how PPD is taking advantage of our industry-leading people, technology and processes to offer more effective and efficient adaptive and intelligent monitoring plans."   ]]> https://biospectrumindia.com/news/97/5053/seegene-intros-allplex-assays-based-on-mudt-next-gen-qpcr-technology.html https://biospectrumindia.com/news/97/5053/seegene-intros-allplex-assays-based-on-mudt-next-gen-qpcr-technology.html Thu, 06 Nov 2014 15:29:05 +0530 Seegene a leading developer of multiplex PCR technologies, has announced that it is introducing the first three comprehensive Allplex assays using its next-generation qPCR technology, called MuDT. The assay launch menu includes a 26-target Respiratory Full Panel, a 26-target Gastrointestinal Infection Full Panel, and a 27-target Sexually Transmitted Infection Full Panel. MuDT is a disruptive qPCR technology that allows simultaneous detection and quantification of multiple target analytes in a single fluorescence channel, without melt curve analysis after amplification. With the introduction of these new Allplex assays, Seegene now provides the most comprehensive multiplexed PCR molecular infectious disease panels in the industry. "We have spent tremendous effort on developing innovative PCR chemistry technologies to meet the needs of molecular laboratory professions. Because MuDT enables the detection of multiple target genes in a single channel without melt curve analysis, MuDT is a true next-generation qPCR technology that will re-invigorate the real-time PCR based market. The Allplex assays can be an crucial clinical tool in accurate and cost-effective disease/symptom-based diagnosis and the efficient management of patient care," said Dr Chun, Jong-Yoon, founder, CTO and CEO of Seegene. The company will feature its new Allplex infectious disease portfolio at the MEDICA 2014 trade fair in Düsseldorf, Germany.   ]]> https://biospectrumindia.com/news/97/7198/applikon-signs-distributor-agreement-with-spinco-biotech.html https://biospectrumindia.com/news/97/7198/applikon-signs-distributor-agreement-with-spinco-biotech.html Wed, 05 Nov 2014 16:31:14 +0530 Mr Erik Kakes, executive VP, sales & marketing, Applikon Biotechnology said, "In Spinco Biotech we have found a partner organization that matches the quality of equipment and support that we are aiming to bring to the worldwide biopharmaceutical market. Our range of high end bioreactor systems complements the product range of Spinco and their excellent after sales organization guarantees our customers the optimal support." The financial terms of this new agreement were not disclosed. "This new agreement offers our customers innovative solutions and total quality satisfaction. We are very pleased to be working with the Applikon Biotechnology team and look forward to a long-term successful relationship," said Mr Arvind Thyagarajan, director, business development, Spinco Biotech.       ]]> https://biospectrumindia.com/news/97/5544/thermo-fisher-scientific-expand-transfection-reagent-portfolio.html https://biospectrumindia.com/news/97/5544/thermo-fisher-scientific-expand-transfection-reagent-portfolio.html Wed, 05 Nov 2014 15:15:40 +0530 Thermo Fisher Scientific has announced the launch of a new high-efficiency transfection reagent for mRNA delivery in neurons and primary cell types, Lipofectamine MessengerMAX. It offers up to a five times the efficiency of DNA reagents and enables researchers to easily transfect biologically relevant cell models without electroporation or viruses. Researchers studying these cells have been faced with challenges due to limited options in the market. To transfect the cells, Lipofectamine MessengerMAX uses novel lipid nanoparticle technology optimised to deliver the highest amount of mRNA possible without entering the nucleus. "In order to maximise the product's efficiency, we have designed it to protect mRNA against degradation and to deliver the maximum amount of mRNA in the cytoplasm of the cells," said Mr Xavier de Mollerat du Jeu, associate director, cell biology at Thermo Fisher Scientific. He added, "This ensures a strong and sustained protein expression and transfection efficiencies of up to 80 percent in primary cells." It is for research use only and not intended for diagnostic procedures.   ]]> https://biospectrumindia.com/news/97/5537/covidiens-hawkone-directional-atherectomy-system-receives-fda-clearance.html https://biospectrumindia.com/news/97/5537/covidiens-hawkone-directional-atherectomy-system-receives-fda-clearance.html Wed, 05 Nov 2014 15:14:55 +0530 Covidien has announced US Food and Drug Administration 510(k) clearance for the HawkOne directional atherectomy system. The latest addition to its directional atherectomy portfolio, the system provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease (PAD). The FDA approval of the system enhances the company's leading peripheral vascular portfolio. "Covidien is committed to being the clear first choice for our physician and hospital partners by delivering new innovative technologies that help save and improve patient lives. The FDA clearance of the HawkOnesystem enhances our leading peripheral vascular portfolio and further demonstrates Covidien's leadership in the atherectomy space," said Mr Brian Verrier, president, peripheral vascular, Covidien.     ]]> https://biospectrumindia.com/news/97/6316/indian-develops-wearable-device-to-track-status-of-heart.html https://biospectrumindia.com/news/97/6316/indian-develops-wearable-device-to-track-status-of-heart.html Mon, 03 Nov 2014 15:37:58 +0530 An Indian scientist has developed 'The Inner You (INYU)' a wearable device capable of tracking the status of the heart and your overall physical and emotional health. "The Inner You (INYU) is a wearable device that helps the user to track and manage his or her physical as well as emotional health," said Mr Srinivasan Murali, co-founder and CEO of the Switzerland-based SmartCardia, the company that developed the device. The device sends real-time physiological signals from the body like ECG, breathing, skin conductance and physical activity to smartphone and other smart-gadgets via Bluetooth 4.0. 'The user can see the signals immediately on his or her mobile phone. It can also be used for managing a healthy lifestyle, as it tracks the emotional and physical health aspects, such as the stress level, body fat and physical activity,' Mr Murali explained. 'I hope the device will be highly beneficial for India. It can be used to track Electrocardiogram (ECG), breathing and key vital signs of users, so that they can get timely feedback from the doctor,' he further added.   The device would be priced at around Rs 9,000.   ]]> https://biospectrumindia.com/news/97/6874/manufacturing-indigenously-biosuppliers-chase-their-dream.html https://biospectrumindia.com/news/97/6874/manufacturing-indigenously-biosuppliers-chase-their-dream.html Mon, 03 Nov 2014 10:32:00 +0530 The 'Make in lndia' slogan by the prime minister, Narendra Modi may not sound new to the biosupplier industry that has been looking at this option for few years now. However, the idea of introducing low cost India made research products' competing with multi-national firms was not promoted at a large sale due to many complications including quality, affordability and convincing of clients. The major factors that have led to the non- initiation of the manufacturing are believed to be within the circles of the policymaking also. The industry has been demanding special attention for establishing plants including fair tax regime and land at lesser price. However, the policymakers seem to have so far ignored the requirements of this tiny sector due to apparent lack of understanding of its importance. Confident of doing it? There are many erstwhile distributors of multi-national firms who want to set their feet in the manufacturing but are doing it rather slowly or cautiously. The maximum opportunities lie in consumables including reagents, 80 percent of whom are imported. Mr Arun Prakash, CEO, Genetix Biotech Asia which also has dabbled in the manufacturing its own range of products, says, "The key strategy initiatives of our company includes focus on our own brand building by introducing world class quality products at most affordable price." Echoing similar views, Mr DK Dubey, managing director, 3D BlackBio says, "Our strategy is to produce world class molecular reagents for lifescience R&D in Indian manufacturing facility. We want to provide top class products at affordable prices in time as substitution to imports."   "We expect the government to give us support. We are dependent completely on companies in China and Germany for technology. It is not easy to manufacture reagents here because we require highly skilled people as we can't afford even any pipetting errors. For that it is foremost importance that Indian scientists shed their casual attitude. If India has to play a key role in biotech in future, it has to develop disciplined skills. The spending has to be right and with accountability. We have to promote ethical work culture with a sense of giving back to our motherland. "Dr Ushakar Nag, director, DSS Takara Bio India and business manager, DSS ImageTech. But the major issue has also been to maintain the quality and yet remain affordable. This is the area where perhaps the companies are struggling in. Also, there is lack of venture funding or seed funding for biotech manufacturing for research reagents. There is absence of culture that connects research labs with commercial companies," says Mr Rupinder Singh, CEO, BioHouse Solutions, while adding further "Government talks about innovation but forgets to address self-dependency of our country for regular research items. There is absence of subsidized programmes to boost such manufacturing. Also, lots of dollars go into importing these products and if manufactured locally, we can do two to three times more research with the same amount." Given the right kind of support, there is hardly any doubt on the capabilities of Indian biosuppliers to do it. However, they will have to rise to the occasion and join hands to push it further. The manufacturing of research products in India is as important as research itself as it will hasten the process and the delivery of end product. Meeting expectations a challenge The one important thing that can make or break the idea is the approval of clients who too have grown smart and want value for the money. Obviously, a researcher running low on funds has to be doubly sure about the product he uses to get quality results in a project with deadlines. For the multi-national companies, this is always a priority and infact, this is the reason why scientists prefer such products even if expensive. In words of Mr Paul A Smaltz, executive vice president, Pharma, Avantor Performance Materials, "Many of the Indian pharma facilities are doing contract manufacturing, or doing runs for clinical trials. It makes difficult to forecast their demands for raw materials. They may require it quickly and thus keeping in view, we are producing key agents and excipients in India to serve their needs." Says Dr Siva Kumar Pasupathi, LDA Country Head, Agilent Technologies, India, "There aren't many Indian players in instruments and the market continues to be dominated by the global MNC players. These companies form our competition in India as well. We have often seen that competition emphasizes its prices and discounts, whereas at Agilent, our focus is always on the quality of the product. In the short-term, this may affect us adversely from time to time, but we believe that customers will always prefer a better product to a cheaper one. Our dependence on dealers and the rupee depreciation have both hit us hard, and sometimes we have been non-competitive on prices, but despite that we have done well." Let us hope that this doesn't just remain merely a talking point and the biosupplier industry takes up the challenge and build confidence not only among themselves but in the minds of scientists too. It is not only the question of just producing but also remaining updated and introducing the new improved techniques. Research and development in order to compete is not new but it is just that the quality will have to be at par with the established brands. For Indian biosupplier turned manufacturers, the innovation in processes shall be important to stay in the business. ]]> https://biospectrumindia.com/news/97/5561/perkinelmer-acquires-ceiba-solutions.html https://biospectrumindia.com/news/97/5561/perkinelmer-acquires-ceiba-solutions.html Sun, 02 Nov 2014 11:40:00 +0530 PerkinElmer has announced the acquisition of Ceiba Solutions, a sciences and laboratory IT software and services company. The company will integrate Ceiba's capabilities into its OneSource services, which aim to reduce complexity in laboratories and increase efficiency, enhancing the ability to accelerate science. OneSource delivers a complete portfolio of laboratory services including Lab IT, Compliance, Asset Informatics and Analytics, Lab Relocation, Scientific Services and multivendor instrument service and repair. Ceiba's solutions will specifically enhance the OneSource Lab IT portfolio, which includes lab computing, scientific application services, scientific data services, and computer systems validation. "As customers seek solutions and business models to help drive more productive science for their global enterprises, our ability to expand our offering in domain-specific and lab IT capabilities through this acquisition enables us to provide an integrated offering that helps accelerate their science," said Mr Jon DiVincenzo, president, environmental health, PerkinElmer. He added, "Ceiba's solutions, including its managed services, certification and informatics technologies, enhance our OneSource offering with advanced tools and expertise to contribute to accelerating scientific breakthroughs."   ]]> https://biospectrumindia.com/news/97/5170/google-working-on-disease-diagnosis.html https://biospectrumindia.com/news/97/5170/google-working-on-disease-diagnosis.html Sun, 02 Nov 2014 10:56:00 +0530 Google's lifescience company, Google's X lab has announced its new project, the "Nanoparticle Platform" to develop a pill that could send microscopic particles into the bloodstream in an effort to identify cancers, imminent heart attacks, and other diseases. The project is part of the company's wider effort to develop new technologies capable of improving healthcare. The company is making nanoparticles that combine a magnetic material with antibodies or proteins that can attach to and detect other molecules inside the body. The pill that contains these particles enter the bloodstream in an attempt to identify molecules that would indicate certain health problems, a wearable device could use their magnetic cores to gather them back together and read what they've found. "Google X's job is to take on the big problems, to try to find clever solutions to big problems, and one of the problems we decided to tackle was healthcare. The way in which we envision doing this is inverting the paradigm in medicine-which is currently reactive and episodic-to a new paradigm that is proactive and cumulative," said Mr Andrew Conrad, the head of lifesciences inside the company's Google X research lab. The wearable device that reads these particles, could be configured to send information, across the internet, back to a doctor. The idea is to monitor health in a more consistent way. The company is looking for partners who would license the technology and bring products to the market.   ]]> https://biospectrumindia.com/news/97/3917/biotek-secure-patent-for-microplate-washers.html https://biospectrumindia.com/news/97/3917/biotek-secure-patent-for-microplate-washers.html Sat, 01 Nov 2014 11:01:00 +0530 BioTek has been awarded US Patent 8,858,718, covering the use of ultrasonic devices to check for clogged manifold tubes and to clean the manifold tubes of a microplate washer automatically. The two features are known as Verify and Ultrasonic Advantage and are available in BioTek's 405 family of microplate washers. Using Verify technology on the 405 washer, the user can run an automated routine to check for blockages, typically caused by protein or salt build-up in the aspirate and dispense tubes of the 405's manifold. It uses ultrasonic pulses to determine that the volume dispensed or aspirated per tube meets specified variation limits. Potential blockages are reported visually via the onboard touchscreen display or software or via the LHC PC software. If blockages are noted, the user can proceed to run an automated cleaning routine using the Ultrasonic Advantage trough to immerse and efficiently clean all manifold tubes. The two functions help prevent potential assay failure and equipment downtime commonly caused by blockages in the small diameter tubes of the microplate washer.   ]]> https://biospectrumindia.com/news/97/5163/a-new-immunoassay-by-thermo-fisher-scientific.html https://biospectrumindia.com/news/97/5163/a-new-immunoassay-by-thermo-fisher-scientific.html Sat, 01 Nov 2014 10:53:00 +0530 Thermo Fisher Scientific has announced the launch of its new "Thermo Scientific DRI Hydrocodone/Hydromorphone Assay". The new assay is a homogeneous enzyme immunoassay that specifically detects hydrocodone and major metabolites in human urine at a 300 ng/mL cut-off. The assay utilizes ready-to-use liquid reagents, calibrators, and controls, and can be run in qualitative and semi-quantitative modes. The assay has more than 100 percent cross-reactivity to major metabolites hydromorphone and hydromorphone glucuronide. DRI Hydrocodone or Hydromorphone Assay demonstrated good correlation with LC-MS/MS and has excellent assay precision. It is a sensitive, specific and easy-to-use screening tool for hydrocodone and major metabolites in urine samples. This assay is "For Criminal Justice and Forensic Use Only".   ]]> https://biospectrumindia.com/news/97/4602/sakra-world-hospital-launches-apps-for-arthritis.html https://biospectrumindia.com/news/97/4602/sakra-world-hospital-launches-apps-for-arthritis.html Sat, 01 Nov 2014 10:11:00 +0530 Sakra world hospital has launched a first-of-its-kind "Augmented Reality (AR)" app. It is an interactive platform for patients to understand the concepts of arthritis and joint replacement. The 'Augmented Reality App' enables the surgeon to show the patient a composite 3D view of how the knee joint looks and moves and explain the steps of joint replacement surgery. It works on any camera enabled smart phone or tablet. The 3D knee that emerges, automatically superimposes on the patient knee itself, making it look like the patient can visualize his own knee in 3D. As the patient moves and rotates his/her knee, the 3D image also rotates accordingly, giving the patient a 360-degree understanding of his/her knee ailment and the surgical procedure. Along with this app, they have also introduced a 'Power of Touch' app, which is a patient-friendly, touch screen educational software and is a one stop information treasure on everything related to arthritis. It will enable a patient or the patient's family understand what are the causes and effects of arthritis and also how a total knee replacement (TKR) works, its benefits and the care and rehabilitation to be undertaken post a surgery and much more. This app has been introduced to ensure that the patient takes an informed decision The interactive app provides an engaging way for demonstrating to the patient the symptoms of arthritis, myth busters, and how TKR helps. It also educates the patient on the options available and the procedure including post-operative care and rehabilitation details. Dedicating the two-advanced technology apps to the patients of arthritis, Dr Raajiv Singhal, group CEO, Sakra World Hospital said, "The ability to instantly image the knee in 3D on top of the patient's actual knee anatomy is very powerful for the surgeon to educate the patient by giving the patient improved sensory perception." Dr Singhal further added, "Millions of patients in India are suffering from arthritis today and only 130,000 undergo TKR, the main reason being lack of awareness among patients. Hence educating patients is a must. They must avoid delaying the surgery since now here are newer technologies implants which last for 30 years and hence they don't need to continue living with pain.'     ]]> https://biospectrumindia.com/news/97/5390/a-new-product-for-microbial-research-from-thermofisher.html https://biospectrumindia.com/news/97/5390/a-new-product-for-microbial-research-from-thermofisher.html Fri, 31 Oct 2014 11:59:00 +0530 Thermo Fisher Scientific introduced an Ion 16S Metagenomics Kit that leverages the Ion Torrent sequencing platform and Ion Reporter for seamless assessment of mixed bacterial populations. It provides a streamlined method for identifying bacteria from mixed culture samples. The new kit is designed for use with the Ion PGM System and Ion Reporter software for data analysis. "The rapidly growing body of evidence supporting the microbiome's role in human health has inspired our R&D team to create a complete solution that leverages the speed and accuracy of next generation sequencing. The new Ion16S Metagenomics Kit now provides scientists with a fast and low-cost approach to elucidate what is yet to be discovered in this emerging field of research,"said Mr Chris Linthwaite, head of genetic sciences research for Thermo Fisher Scientific. The 16S Metagenomics Kit's speed and ease-of-use also has the potential to detect contaminants in commercial facilities in conjunction with currently available genotypic identification methods, allowing users to reduce time and cost of quality control. According to Mr Michael Brewer, head of pharmaceutical analytics, bioproduction at Thermo Fisher Scientific, "The Ion 16S metagenomics system is a great complement to the industry-leading genotypic microbial identification method employed by the MicroSEQ Rapid Microbial Identification System. The kit enables customers to rapidly assess the bacterial population in complex samples via genus or species level identification, generally without a culture step. We see the combination of these two approaches as a new paradigm in accuracy and rapid time-to-result for identifications in the modern microbiology lab." The Kit is for research use only and not to be used in diagnostic procedures.   ]]> https://biospectrumindia.com/features/97/5516/astrazeneca-insources-its-it-ops.html https://biospectrumindia.com/features/97/5516/astrazeneca-insources-its-it-ops.html Fri, 31 Oct 2014 09:56:00 +0530 AstraZeneca which outsourced its IT requirement to IBM in 2001, is now ending its relationship with the IT major through the unveiling of its own new GTC, allowing insourcing of its IT operations. Faced with a series of R&D challenges and changes at the senior management level, AstraZeneca planned to invest in its new GTC at Chennai, which will significantly cut costs and will enable the company to fasten its grip on its work. Though Bangalore is known to be the Silicon Valley of India, AstraZeneca sees Chennai as the perfect location for its primary GTC. The company initially shortlisted a host of countries in Asia and Eastern Europe, but picked Chennai specifically to set its technology center in India. "Chennai fits well with our strategy. The city is India's healthcare capital and along with leading hospitals and medical colleges, the city has a strong focus on the biotechnology industry sector. Equally important, Chennai is an emerging IT hotspot and there's a large population of IT talent here as well as in neighboring regions," said AstraZeneca's spokesperson to BioSpectrum.   "The arrival of the Chennai facility is just the start," it said. "We plan to establish global technology centres in San Francisco, USA in 2015, and extend our capability with two additional regional satellite centres in China and Eastern Europe." However, it does not intend to build additional GTCs in other locations in India. At 100,000 sq ft, the GTC in Chennai will be the largest of all the centres AstraZeneca has planned. This centre will drive the company's solutions, tools, technologies and capabilities enabling it to create innovative and pioneering drugs. The GTC is expected to support 50,000 of its staff in 100 countries. The centre currently employs 60 people, and it aims to expand the workforce to approximately 300 in the first year. "We aren't able to share figures for 2015-16 at this stage," said the spokesperson. AstraZeneca failed to comment on the investment that went into erecting the Chennai GTC. However, it is estimated that the new IT outsourcing centre is worth $9 million. According to the company, the Chennai's GTC will deliver application development, SAP, infrastructure management and operations, cloud, mobile, service operations and maintenance.   "One of our key objectives is to achieve technical leadership in our IT, and our Chennai centre will give us the ability to build the world-class technical capability we need to achieve. We are looking to recruit individuals with global work experience, particularly consultants and engineers for large enterprise application platforms," commented AstraZeneca. AstraZeneca's GTC in San Francisco is expected to be operational in 2015, and will be a smaller technology centre with a few experts who will be able to use it as a base to tap into innovative tech thinking and technology in the area. ]]> https://biospectrumindia.com/news/97/5389/abbott-expands-its-medical-device-business.html https://biospectrumindia.com/news/97/5389/abbott-expands-its-medical-device-business.html Thu, 30 Oct 2014 13:18:58 +0530 Abbott has announced that it has entered into an agreement to purchase Topera, a private, venture-backed medical device company focused on developing innovative electrophysiology technologies to improve the diagnosis and treatment of atrial fibrillation.  Under the terms of the acquisition, the company will acquire all outstanding equity of Topera for $250 million upfront, plus potential future payments tied to performance milestones. Through this acquisition, Abbott enters the catheter-based electrophysiology market, an approximately $3 billion global market that has been growing annually at double-digit rates. Topera, has developed a novel diagnostic catheter and mapping software, or rotor identification system, which help physicians identify and target the specific areas of a person's heart that are perpetuating atrial fibrillation. "There is significant room to use advanced rotor identification technologies to improve the success rate and reduce the need for multiple ablation procedures, and thus improve the health of people with atrial fibrillation. The Topera acquisition provide a foundational entry into the large, high-growth electrophysiology market, with differentiated technologies that can transform the way physicians treat people with complex heart rhythm disorders," said Mr John M Capek, executive vice president, medical devices, Abbott. Completion of the Topera acquisition is subject to customary closing conditions, including antitrust clearance. It is expected to close in the fourth quarter of this year.   ]]> https://biospectrumindia.com/news/97/5141/thermo-fisher-scientific-expands-its-portfolio.html https://biospectrumindia.com/news/97/5141/thermo-fisher-scientific-expands-its-portfolio.html Thu, 30 Oct 2014 12:09:00 +0530 Thermo Fisher Scientific has announced the launch of its Heracell VIOS incubator series, new CO2 incubator that combines latest technologies for optimal cell growth and contamination control designed to create uniform growth conditions with consistency and reliability. The Thermo Scientific Heracell VIOS incubator series is ideal for academic research and pharmaceutical applications, allowing scientists to maximize their productivity with excellent reproducibility, reliability and efficiency. "Reproducibility and contamination prevention are critical when it comes to sensitive cultures in order to ensure the integrity of your research. Our new Heracell VIOS series leverage our long history of CO2 technology leadership with innovations, including our new THRIVE active airflow and proven decontamination that are critical for today's demanding cell culture applications," said Mr Doug Wernerspach, global business director, Thermo Fisher Scientific. The Heracell VIOS is equipped with ISO class 5 HEPA filters to protect against airborne microbes and particulates , Steri-Run, a fully automatic on-demand overnight 180°C sterilization cycle assures uniform 6-log high-temperature sterilization on all surfaces , Condensation-free chamber with covered, protected humidity reservoir , 100 percent pure copper interiors to provide lasting sustainability and easy maintenance. It comes with an intelligent iCAN touchscreen interface which provides complete data visibility to monitor all incubator interaction, featuring on-screen menu prompts, error and usage monitoring, downloadable data logging with a standard USB, performance trend graphing and multiple language selection.   ]]> https://biospectrumindia.com/features/97/5985/e-health-lack-of-common-platforms-a-major-challenge.html https://biospectrumindia.com/features/97/5985/e-health-lack-of-common-platforms-a-major-challenge.html Thu, 30 Oct 2014 09:52:00 +0530 Today the challenge India has, much like many other countries, is to not only reach the poor but also to ensure a level of healthcare that reflects equity. The pace of development of e-health and m-health is as fast as it has ever been, and the penetration of devices like mobile phones is both unprecedented and increasing. All the while, the push to have more care done at home and away from the hospital is gaining traction and developing increasing numbers of community health workers. As such, the potential for m-health seems boundless in its ability to change the way care can be delivered. "Mobile health and e-health have had a tremendous uptick in both interest and utilization, from places like the US and Kenya and many places in between. The understanding that m-health and e-health tools can improve healthcare delivery across the spectrum of the healthcare experience is promoting more uptake, both large and small scale, both public and private," opined Dr David Walton, director, global health, ThoughtWorks. But there is limited use of mobile applications in which healthcare is facilitated in global north countries. "There are plenty of monitoring applications and wellness activity trackers to help people measure the number of steps they've taken in a day, but something as simple as SMS messages to vulnerable pregnant women is rarely seen, even in areas with limited access to practitioners or hospitals," he pointed out.   The reliance on diagnostic tools and expensive tests is also pervasive in places like the US. But in places like India, doctors have even devised a way to measure hemoglobin for pennies on the dollar. "This type of frugal innovation is what has driven and what will continue to drive affordability and increasing access in resource-constrained settings," Dr Walton explained. He said that the major challenges in the m-health and e-health sector is the lack of standardization of approach and the lack of common platforms. "I think that in developing countries much can be learned from places like the United States, specially, what not to do. The US has failed on so many levels of creating accessible and affordable healthcare to its people," he pointed out regrettably. Affordability and accessibility of healthcare often fall to the public sector as the primary purveyor of healthcare for countries both in the global north and in global south. "Working with the government allows improvement in delivery at scale, and particularly helps in closing the gap for masses who are traditionally marginalized," suggested Dr Walton.   Dr Walton observed that the recent trials and tribulations of the Affordable Care Act (ObamaCare) is a small step in the right direction of addressing the fact that so many Americans lack access to even the basics of primary care. Talking about global southern countries, he says, the ability of the public sector to deliver healthcare is hamstrung by a myriad of issues including the brain drain of qualified medical professionals, expensive pharmaceuticals, difficulty with supply chain, and inadequate medical infrastructure among others. "The ability of developing nations to leapfrog the status quo of developed nations and create solutions that can truly enhance care delivery has already been established, and I think that trend will continue," he commented. The role of open source software is imperative, particularly in healthcare. The tools that are used to improve healthcare - whether it be software, information, new research, or new pedagogical tools to improve teaching methods - can only create an equitable widespread improvement in outcomes if they are available to everyone. "The dissemination of knowledge and technology can often be hamstrung by private licensing and propriety fees. Open source software is one way to remove those barriers, and allows software and technology to be used by those that, more often than not, need it most," noted Dr Walton.   For m-health, there is a trove of evidence that demonstrates fewer errors and improved patient outcomes. However, the penetration of m-health in developing nations, especially within clinics and hospitals, is still small. As a company, said Dr Walton, we seek to partner with others to facilitate their ability to deliver high quality, affordable healthcare. "That includes both public sector and private sector partners across all geographies, but particularly in the global south," he added. "We are also open to working with the private sector, as we understand the role the private sector can play in being leaders in the space both nationally and internationally, and are looking to improve delivery of care to all walks of life," expresseed Dr Walton. Currently, ThoughtWorks has diverse set of clients in the sector, from NGOs in the Americas and in Africa, to Ministries of Health in Africa and Asia, as well as clinics and hospitals. "Our projects are also equally as diverse - from mobile health applications focused on community health workers to hospital management information systems, to developing shared health records for nation states," he concluded. ]]> https://biospectrumindia.com/news/97/5134/covidien-unveils-its-new-product.html https://biospectrumindia.com/news/97/5134/covidien-unveils-its-new-product.html Wed, 29 Oct 2014 14:46:49 +0530 Covidien has announced the launch of ReliaTack articulating reloadable fixation device, the first and only of its kind for laparoscopic (minimally invasive) hernia repair. "Developed with valuable input from surgeons, the ReliaTack device, combined with our recently-launched Symbotex composite mesh, benefits patients while helping drive greater operating room efficiency and economic benefits. The ReliaTack fixation device overcomes numerous physical and ergonomic challenges in ventral hernia repair by allowing a wide variety of angles to more effectively position and secure hernia mesh,"said Mr Rob Claypoole, vice president and general manager, Hernia, Covidien. The ReliaTack device has received FDA 510(K) clearance. "Covidien's proven tack design helps surgeons ensure that the mesh will stay in place, one of the key concerns of hernia repair surgery. By offering interchangeable tack reload sets, ReliaTack helps to eliminate much of the waste associated with non-articulating devices," said Mr Matt Cohen, vice president, R&D Covidien.     ]]> https://biospectrumindia.com/news/97/4975/covidien-delivers-latest-innovation-in-lung-cancer-diagnosis.html https://biospectrumindia.com/news/97/4975/covidien-delivers-latest-innovation-in-lung-cancer-diagnosis.html Tue, 28 Oct 2014 12:52:29 +0530 Covidien has unveiled a next-gen version of its superDimension Navigation System software. The updated software features a more intuitive interface that helps reduce time spent by physicians planning a procedure and enhances the visualisation of the airways of the lung. Covidien's superDimension navigation system enables a minimally invasive approach for accessing difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease. The enhanced navigation software is the latest in a series of superDimension enhancements. Earlier this year, Covidien launched the superDimensionTriple Needle Cytology Brush, a uniquely designed minimally invasive biopsy tool developed to improve diagnostic yields of tumor and lesion samples. Dr D Kyle Hogarth, associate professor of Medicine and director of Bronchoscopy at the University of Chicago said, "Covidien partnered with pulmonologists to redesign the superDimension software and introduce new biopsy tools to improve patient outcomes. This latest version of the superDimension software allows me to find tumors sooner by reducing case planning time required prior to a procedure, simplifying the navigation process, and enhancing the visualization. The innovative design of the Triple Needle Cytology Brush allows me to capture larger tissue samples, which have the potential to provide more information for the patient's diagnosis and prognosis." "These advanced tools and technologies demonstrate Covidien's commitment to expand the specialized lung health products available to pulmonologists and thoracic surgeons," said Mr Chuck Brynelsen, president, Early Technologies, Covidien. He added, "We continue to create a comprehensive portfolio of instruments and technologies designed to help the physician improve how lung cancer is diagnosed with the ultimate goal of improving patient health."   ]]> https://biospectrumindia.com/news/97/4956/thermo-fisher-scientific-announces-third-quarter-2014-results.html https://biospectrumindia.com/news/97/4956/thermo-fisher-scientific-announces-third-quarter-2014-results.html Mon, 27 Oct 2014 14:36:25 +0530 Thermo Fisher Scientific has reported its financial results for the third quarter ended September 27, 2014. For the third quarter of 2014, adjusted EPS grew 32 percent to $1.71, versus $1.30 in the third quarter of 2013. Revenue for the quarter grew 31 percent to $4.17 billion in 2014, versus $3.19 billion in 2013. Organic revenue grew 4 percent, with acquisitions, net of divestitures, increasing revenue by 27 percent and currency translation having a negligible effect. Adjusted operating income for the third quarter of 2014 increased 48 percent compared with the year-ago period, and adjusted operating margin expanded to 21.9 percent, compared with 19.4 percent in the third quarter of 2013. "We are pleased to extend our long track record of consistently delivering strong adjusted EPS growth. We leveraged our solid top-line results and our culture of operational discipline to achieve excellent performance on the bottom line. I'm also pleased to report that the Life Technologies integration is going very well, and it was another great quarter for innovation across our technology platforms," said Mr Marc N Casper, president and chief executive officer, Thermo Fisher Scientific. He added, "We launched a number of new products during the quarter to strengthen our leadership position in the key markets we serve. Among the highlights was our new Vanquish UHPLC system and columns, a potential game-changer for customers in applied markets who need to analyze high volumes of samples."   ]]> https://biospectrumindia.com/news/97/4918/perkinelmer-launches-new-imaging-system.html https://biospectrumindia.com/news/97/4918/perkinelmer-launches-new-imaging-system.html Mon, 27 Oct 2014 14:32:14 +0530 PerkinElmer has announced the launch of its Mantra Quantitative Pathology Workstation with inform Image Analysis Software for cancer immunology and immunotherapy research. It enables researchers to investigate the spatial relationships among multiple types of immune cells simultaneously within and around solid tumors.  It is an easy-to-use, compact, quantitative pathology imaging solution for quantifying biomarkers and protein expression in situ. It enables the development of multiplexed immune cell and protein expression profiling assays for cellular phenotyping in the tumor and tumor microenvironment of standard formalin-fixed, paraffin-embedded (FFPE) tissue sections. The Mantra workstation was developed for use with the company's comprehensive cancer immunology research workflow solution. It readily integrates with its Opal multiplexed immunohistochemistry reagents and inForm software's new quantitative per-cell analysis for phenotyping immune cells in situ. The system is designed to augment how a pathologist works at the microscope so that users can quickly and easily navigate slides at different magnifications. They can also acquire images with minimal microscope manipulation to visualize the distributions of multiple immune cell phenotypes simultaneously. "Cancer immunology research provides hope for better outcomes, especially as new drug candidates make their way through the development process. PerkinElmer is transforming how researchers can see the distributions of immune cells in the tumors they are treating, which can have a significant impact on their understanding of the immune system's role in cancer," said Mr Brian Kim, president, Life Sciences and Technology, PerkinElmer.   ]]> https://biospectrumindia.com/news/97/4943/thermo-fisher-scientific-adds-to-its-chromatography-portfolio.html https://biospectrumindia.com/news/97/4943/thermo-fisher-scientific-adds-to-its-chromatography-portfolio.html Mon, 27 Oct 2014 13:32:33 +0530 Thermo Fisher Scientific has announced the launch of POROS XQ chromatography resin, which provides optimized bead morphology and unique surface chemistry to improve anion exchange chromatography. The new high-capacity, high-resolution, salt-tolerant strong anion exchange (AEX) resin offers superior performance, driving higher product yield, improved product purity, and greater process flexibility in either bind and elute or flow-through modes. Built on the unique POROS bead platform, POROS XQ allows high-capacity and high-resolution separations, driving efficient impurity clearance and, ultimately, higher product yields. "The POROS high performing chromatography resins provide unique performance attributes and drive benefits to downstream processing. Now, POROS XQ extends these established benefits to AEX chromatography," said Ms Christine Gebski, product management director, POROS Chromatography, Thermo Fisher Scientific. High-dynamic binding capacity capability allows researchers to use a smaller column size than typical resins, decreasing water and buffer use. With robust salt tolerance, the resin offers scientists process design flexibility and a streamlined process flow. The POROS resin's Rigid 50 µm polymeric beads also feature fully quaternised surface chemistry, allowing for unique selectivity, as well as linear, predictable scalability and performance that is independent of the process throughput.   ]]> https://biospectrumindia.com/news/97/4848/pacific-biosciences-adds-new-products-to-its-portfolio.html https://biospectrumindia.com/news/97/4848/pacific-biosciences-adds-new-products-to-its-portfolio.html Sun, 26 Oct 2014 12:41:00 +0530 Pacific Biosciences has announced the release of P6-C4, a new chemistry software designed to enhance the performance and output of the platform by 45 percent. The latest release increases read length and improves accuracy to further accelerate innovative genomic research in complex organisms such as humans, plants, and animals. The new release, P6-C4, represents the company's 6th generation of polymerase and 4th generation chemistry, further extending the industry's leading average read length to 10,000 - 15,000 bases, with the longest reads exceeding 40,000 bases. The throughput with the new chemistry is expected to be between 500 million to 1 billion bases per SMRT Cell, depending on the sample being sequenced. By providing an increasing number of longer reads per instrument run, the new chemistry enables users to assemble genomes at a higher quality. The P6-C4 chemistry will replace the P5-C3 chemistry and is recommended for all SMRT Sequencing applications, including de novo assembly, targeted sequencing, isoform sequencing, minor variant detection, scaffolding, long-repeat spanning, SNP phasing, and structural variant analysis. "The performance of this new chemistry reflects our commitment to consistently deliver significant improvements in throughput and accuracy to our expanding user base," said Mr Kevin Corcoran, senior vice president of market development, Pacific Biosciences. He added, "With the longest reads now exceeding 40,000 bases, SMRT Sequencing is rapidly becoming the go-to platform for phasing complex genomic regions like full-length HLA genes, and generating gold-standard genome assemblies."     ]]> https://biospectrumindia.com/news/97/4853/agilebio-introduces-snp-manager.html https://biospectrumindia.com/news/97/4853/agilebio-introduces-snp-manager.html Sun, 26 Oct 2014 10:04:00 +0530 AgileBio has announced the release of a new add-on for LabCollector called SNP Manager. This add-on is dedicated to the treatment of SNP (Single Nucleotide Polymorphism) genotyping workflows. Users can generate picking lists and instructions files for their tube pickers (Tube sorter and Floyd 2D) and genotyping process (Fluidigm EP1) machines. When combined with LabCollector samples and documents modules, the SNP Manager add-on allows users to manage tubes and plates containing markers: storage location, stock quantity, status (available, ordered) and suppliers ordering.   ]]> https://biospectrumindia.com/news/97/4716/illumina-to-support-start-ups.html https://biospectrumindia.com/news/97/4716/illumina-to-support-start-ups.html Sat, 25 Oct 2014 13:39:00 +0530 Illumina has announced the selection of three start-up companies for the inaugural Illumina Accelerator funding cycle. The selected companies are Encoded Genomics, EpiBiome, and Xcell Biosciences. It is the world's first business accelerator focused solely on creating an innovation ecosystem for the genomics industry. It is led by Dr Amanda Cashin. "The initial companies in our accelerator rose to the top of a highly competitive application process based on their potential to deliver innovative genomics apps in areas as diverse as healthcare and agriculture. Under Dr Amanda's leadership, Illumina, along with partners Yuri Milner and Silicon Valley Bank, is very excited to work with these entrepreneurs to help them expand the next-generation sequencing market," said Dr Mostafa Ronaghi, Illumina's senior vice president and chief technology officer. The Illumina Accelerator will provide selected startups with seed investment, business guidance, access to company's sequencing systems and reagents, and fully operational lab space in the San Francisco Bay Area during the six-month cycle.   ]]> https://biospectrumindia.com/news/97/4695/horizon-discovery-inks-pact-with-a-pharma-company.html https://biospectrumindia.com/news/97/4695/horizon-discovery-inks-pact-with-a-pharma-company.html Sat, 25 Oct 2014 12:08:00 +0530 Horizon Discovery Group has announced that its Horizon CombinatoRx division has been contracted by a top ten pharma company to profile a lead oncology asset. Under the terms of the agreement, Horizon CombinatoRx will be paid approximately $450,000 (£276,000) for work to be completed within a six month period. Dr Darrin M Disley, chief executive officer of Horizon Discovery Group said, "We are delighted that Horizon CombinatoRx continues to gain traction in the market, following its acquisition earlier this year. This latest contract with a top ten pharma in the oncology space continues to demonstrate the potential of this business and the value Horizon CombinatoRx can offer to support key drug discovery and development programs in cancer." Horizon will provide services to support proof-of-concept, monotherapy screening, and combination screening for the lead asset. Horizon CombinatoRx provides its partners access to the unique cHTS platform and Chalice analytics software, which enable the screening and analysis of thousands of complementary drug combinations. Combined with Horizon's GENESIS(rAAV, CRISPR and ZFN) gene editing platform and X-MAN isogenic cell line technology, it offers services including novel phenotypic cell-based screens with compound siRNA, shRNA and sgRNA (for CRISPR based screening) libraries.     ]]> https://biospectrumindia.com/news/97/4714/new-elisa-kits-by-bioo-scientific.html https://biospectrumindia.com/news/97/4714/new-elisa-kits-by-bioo-scientific.html Sat, 25 Oct 2014 11:06:00 +0530 Bioo Scientific launches new ELISA kits for quinolone residue detection with the best cross reactivity commercially available. A broad range of flouroquinolone residues can be detected using the AuroFlow Fluoroquinolone Strip Test Kit for Meat, the AuroFlow Fluoroquinolone Strip Test Kit for Milk and the MaxSignal Fluoroquinolone ELISA Test Kit. These tests are rapid qualitative lateral flow assays designed to detect fluoroquinolone antibiotic residues in meat and milk samples. The strip tests, with each use, contain a broad-spectrum antibody capable of detecting a range of fluoroquinolone residues, and are designed for rapid field use or reference lab settings, requiring no heaters, centrifuges, or other expensive lab equipment. Additionally, the company offers sensitive ELISAs for specific quinolones including kits for the detection of enrofloxacin, ciprofloxacin, flumequine, norfloxacin, nalidixic acid, sarafloxacin, ofloxacin, and oxolinic acid. The newest additions to this line of kits for fluoroquinolone residue detection in food and feed samples include the MaxSignal Difloxacin ELISA Test Kit, the Maxsignal Ofloxacin ELISA Kit, the MaxSignal Sarafloxacin ELISA Test Kit and the MaxSignal Oxolinic Acid ELISA Test Kit.   ]]> https://biospectrumindia.com/news/97/4592/a-new-scientific-advisory-board-for-cypher-genomics.html https://biospectrumindia.com/news/97/4592/a-new-scientific-advisory-board-for-cypher-genomics.html Fri, 24 Oct 2014 11:10:00 +0530 Cypher Genomics has announced the formation of a scientific advisory board (SAB) to guide the development and implementation of company's products, which include Mantis, the genome interpretation software as a service offering, and Coral, a biomarker discovery service. Dr Kelly Bethel, Dr Michael Hultner, Dr Myla Lai-Goldman, Dr Arnold (Arnie) Levine and Dr Diego Miralles have joined as members of SAB, alongside Dr Nicholas Schork, co-founder, Cypher Genomics and is also SAB's chair. "Cypher has gathered an exceptional team of scientific advisors who each bring distinctive skill sets to the board. Dr Bethel and Dr Lai-Goldman are physicians who  have routinely utilized genomic information in their medical practices and at leading diagnostic companies, respectively. Dr Hultner innovates at the interface of technology and healthcare with a focus on population genomics and Dr Miralles focuses on emerging technologies with applicability to pharmaceutical companies," said Dr Ali Torkamani,the company's co-founder and chief scientific officer. He added,  "With his co-discovery of the p53 tumor suppressor gene, Dr Levine is renowned as a pioneer in cancer research and genomics. We look forward to working with these thought leaders to advance Cypher's genome interpretation technology to find clinically meaningful information in human sequencing data to improve healthcare." Cypher's fast, accurate and robust genome interpretation and analysis technologies facilitate differentiated molecular tests, efficient clinical trials and enable precision therapeutic decisions.     ]]> https://biospectrumindia.com/news/97/5830/intel-ge-care-innovations-partners-with-kinesis-health-.html https://biospectrumindia.com/news/97/5830/intel-ge-care-innovations-partners-with-kinesis-health-.html Fri, 24 Oct 2014 11:02:00 +0530 Intel-GE Care Innovations, a joint venture between Intel Corporation and GE Healthcare, and Kinesis Health Technologies have announced a partnership to market and distribute QTUG, a mobility and falls risk assessment technology. QTUG is designed to give a more comprehensive view of an individual's risk of falling. QTUG is intended for use by healthcare professionals who assess falls risk in older adults, such as falls specialists within hospitals and community-based care nurses to help eliminate falls for residents. "Falls are a major cause of injury and hospitalization, especially among older Americans. I believe our partnership with Kinesis Health Technologies will bring physical therapists and other clinicians a superior method of determining an individual's risk for falling, and provide the necessary support and information in order to intervene and reduce that risk," said Mr Sean Slovenski, chief executive officer at Care Innovations. According to Mr Seamus Small, chief executive officer of Kinesis Health Technologies, "The direct and indirect costs of falls to society are enormous. However, many falls are avoidable, so more effective preventive measures can have a big impact on improving quality of life and reducing financial costs associated with falls." In addition to identifying those patients at high risk of falls, QTUG can also be used to assess a patient's response to therapy on an on-going basis. Falls among older adults are a major problem worldwide, with an estimated 30 percent of adults over 65 falling each year.   ]]> https://biospectrumindia.com/interviews/97/5435/the-days-of-individual-genomic-tests-will-end-soon.html https://biospectrumindia.com/interviews/97/5435/the-days-of-individual-genomic-tests-will-end-soon.html Wed, 22 Oct 2014 11:06:00 +0530 Dr Burke, who has a strong background in functional genomics and gene editing andis currently focusing on reference standards for molecular diagnostics as well as high value bioproduction cell line platforms, shares his views on new age platforms. Cancer diagnostics through mutational analysis and gene expression profiling is being touted to be the next major breakthrough area in clinical practice. Can you share your views on what some of the future directions or trends in this area?The days of performing individual genomic tests is coming to an end. There is likely to be greater panel based or exome testing, increasing the number of biomarkers thatcan be interrogated in a single sample. This is important as samples generated from biopsies are finites, so this is a more effective use of patient specimens. Importantly we are seeing the development of increasingly sensitive techniques that could allow identification of biomarkers in the blood or urine. This would allow earlier detection of cancers, possible pre-visualisation of the tumour and presents the possibility of monitoring the disease to ensure alignment of therapeutic solutions.How does genomics play an important role in Cancer diagnosis? Cancer is not one disease. Even in a person with cancer it's rarely a single disease. Each cancer is made up of different genetic variations, many of which are somatic and therefore occur during life rather than being inherited. Genomics allows us to decode each tumor and to apply the most effective treatment. Given both the cost and potential toxicity of giving an ineffective treatment, genomicsis increasingly centre stage in oncology. How does Horizon's Genesis platform aid in early cancer detection and diagnosis?Horizon's molecular reference standards are currently used as external controls to determine specificity and sensitivity of molecular diagnostic tests. They are alsoused by proficiency schemes who provide accreditation to many labs to confirm the ability and competency of that lab in detecting particular cancer genotypes. Further work is ongoing at Horizon to explore the development of products which would support minimally invasive testing (blood or urine).Can cancer be detected at early-stages using genomic tools?The potential definitely exists to detect cancer prior to the formation of a tumor which is detectable by traditional methods. Blood or urine would be the likely analytes but these pose different technical challenges, including the need for lower limits of detection.Can genomics tools be used to predict cancer inheritance?Yes, there are various predictors of cancer such as BRCA. However most cancers are driven by somatic (sporadic) mutations which are not hereditary. What is your India strategy as while some of the leading products can be sold to private Indian hospitals, most public hospitals will require simpler, portable, easy-to-use and more affordable versions?We do not sell diagnostics. We sell references standards and develop controls for companies that design and market diagnostics. We recognise the importance of accuracy, precision and affordability of our product in supporting the push to beat cancer. Ultimately it comes down to getting the right drug, to the right patient at the right time based on the right test from a diagnostic result. Are there a lot of innovations in this area and how do you see the landscape? NGS is a big driver and then the gradual movement to minimally invasive  approaches such as detecting biomarkers in blood or urine. Informatics is a big challenge as we try to bring together all the scientific and patient data to ensure the best decisions are made. Treating cancer in my opinion is going to become a multi-disciplinary affair to a greater extent than it is currently... The ultra high-end tests in general are perceived by consumers as very expensive. Are such tests affordable to various strata of patients in countries like India?The model for personalised medicine is still maturing. Platforms such as NGS will drive the cost of diagnostics down. The model for drug discovery will evolve to bemore successful supported by the underlying personalised medicine framework. It's going to take time but simply put, base on finite funds, the economics of treatingcancer needs to improve. How do you view the opportunities in India in specific and Asia in general?Very important. You have large populations. The incidence of cancer is rising and importantly there are some variations that seems to be specific to different ethnicities. We need to ensure we have the right data, the right drugs and reasonable expectations to meet these challenges. What are some of the key challenges that you have noticed in the Indian markets/scientists?The infrastructure is a challenge. However I don't see this as rate limiting. I feel that many of the pathologists and oncologist in India are more discerning about adopting new technologies just for the sake of doing something different. Given the state of health economics around the world, I think this is a sensible take. What do you think will be the game changers?NGS with better error rates, improved drug discovery success rate and minimally invasive testing. ]]> https://biospectrumindia.com/news/97/4250/boston-scientific-gets-ce-mark-approval-for-new-pacemakers.html https://biospectrumindia.com/news/97/4250/boston-scientific-gets-ce-mark-approval-for-new-pacemakers.html Mon, 20 Oct 2014 17:21:53 +0530 Boston Scientific Corporation has received CE Mark approval for the ACCOLADE pacemaker family. When implanted with the company's INGEVITY leads, ACCOLADE pacemakers are the first to enable patients to receive full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems. In addition, the Boston Scientific ImageReady technology offers the most flexible MRI options, allowing higher energy scan sequences, and featuring a programmable MRI timer designed to improve patient workflow. In addition to the CE mark approval and launch of the ACCOLADE pacemaker family, the company also received approvals for its VISIONIST and VALITUDE CRT-Ps with quadripolar pacing technology. When paired with the ACUITY X4 pacing leads, these systems offer many options to reach and pace the target location in the left ventricle, potentially improving the patient response to CRT therapy. "We have prioritized investments and now have the first and only subcutaneous ICD, the smallest ICD, and the longest-lasting pacemaker, ICD and CRT devices in the world," said Mr Joe Fitzgerald, executive vice president and president, Rhythm Management. He added, "Now, with the ACCOLADE pacemaker family, we also offer the most flexible MRI conditional pacemaker system, along with advanced diagnostics that assist physicians in detecting atrial arrhythmias. We believe that the provision of automatic daily monitoring and advanced diagnostics to our pacemaker devices will help physicians identify atrial fibrillation sooner, enabling them to initiate patient anti-coagulation therapy to reduce the risk of stroke."   ]]> https://biospectrumindia.com/news/97/4249/medtech-sector-should-be-regulated-separately.html https://biospectrumindia.com/news/97/4249/medtech-sector-should-be-regulated-separately.html Mon, 20 Oct 2014 17:15:59 +0530 The medical devices sector should be excluded from the drugs category and needs to be regulated as per international practices, said the Advanced Medical Technology Association (AdvaMed). Currently, medical devices are catagorized as "drugs" under the Drugs and Cosmetics Act. According to AdvaMed, applying the same regulatory and pricing systems for medical devices as pharmaceuticals could reduce the ability of Indian manufacturers to grow. "There should be a separate regulatory agency for medical devices with adequate trained personnel. Indian medical devices regulation should be harmonized with the guidelines of the Global Harmonization Task Force (GHTF)," AdvaMed vice president Ms Abby Pratt said in a statement. "Medical device industry is valued at $4 billion in India at present but it is a very important part of healthcare. The ecosystem for growth has be developed so that the sector can realize its tremendous potential to solve India's healthcare problems," she added.   ]]> https://biospectrumindia.com/news/97/4128/a-new-dna-profiling-unit-in-jk.html https://biospectrumindia.com/news/97/4128/a-new-dna-profiling-unit-in-jk.html Sun, 19 Oct 2014 10:40:00 +0530 The Jammu and Kashmir government will set up two new divisions in the Forensic Science Laboratory including a DNA profiling unit. "The divisions include DNA profiling and Laboratory facilities and computer-cyber-voice identification and video authentication technology," said Mr H K Lohia, IG, technical services. The state government has invited Expression of Interest (EOI) from reputed and experienced companies and Consortium for setting up these two new divisions. Interested organizations can submit EOI for each division or both the divisions.   ]]> https://biospectrumindia.com/news/97/4013/healthcare-it-attracts-956-million-in-q3-of-2014-.html https://biospectrumindia.com/news/97/4013/healthcare-it-attracts-956-million-in-q3-of-2014-.html Sat, 18 Oct 2014 10:20:00 +0530 Venture capital (VC) funding in the healthcare information technology came to $956 million, raised in 212 deals globally, a decline of 46 percent in terms of dollars compared to the massive $1.8 billion in 161 deals raised in Q2 2014, a rare quarter. However, Q3 2014 was still the second highest quarter for VC funding since 2010. Total VC funding year-to-date adds up to $3.6 billion. This was revealed in a report on funding and mergers and acquisitions (M&A) activity in the sector for the third quarter of 2014 by the Mercom Capital Group, a global communications and consulting firm. Mercom's comprehensive report covers deals of all sizes in Healthcare IT across the globe. "Healthcare IT saw another big fundraising quarter in Q3 with almost a billion raised. Companies from countries outside of the United States, accounted for a record 21 percent share of the funding. While consumer-centric companies attracted the majority of the funding this quarter, M&A has been a different story with most (86 percent) of the deals involving practice-focused companies," commented Mr Raj Prabhu, CEO and co-founder of Mercom Capital Group. Consumer-focused technologies received 65 percent of all VC investments in the third quarter of 2014, with $623 million in 140 deals compared to $678 million in 100 deals in Q2 2014. Areas that received the most funding under this category were Mobile Health with $345 million in 82 deals, followed by Telehealth, which had its best quarter, with $101 million in 16 deals, Personal Health with $85 million in 24 deals, Social Health with $70 million in three deals, and Scheduling, Rating & Shopping with $23 million in 15 deals. Practice-centric companies received $333 million in 72 deals in the third quarter of 2014, compared to $1.1 billion in 61 deals in Q2. Under this category, the areas that received the most funding were Revenue Cycle Management with $75 million in eight deals, and Data Analytics with $71 million in 19 deals. ]]> https://biospectrumindia.com/news/97/3916/waters-expands-its-chromatography-portfolio.html https://biospectrumindia.com/news/97/3916/waters-expands-its-chromatography-portfolio.html Fri, 17 Oct 2014 11:13:00 +0530 Waters Corporation has introduced new size exclusion chromatography (SEC) columns for the characterization of proteins. The XBridge Protein BEH SEC Columns deliver optimal throughput and resolution for size-based separations of protein-based biotherapeutics. The XBridge Protein BEH SEC Columns are packed with 3.5 μm particles and are available in either 200 or 450 Ã… pore sizes for analyzing proteins and other biomolecules ranging in molecular weight from 10,000 - 1,500,000 Da. The columns are designed to operate at higher flow rates and pressures than traditional silica-based SEC columns. These characteristics result in either increased sample throughput or, by using multiple columns in series, greater component resolution. Use of Waters diol-bonded, BEH Technology particles delivers outstanding column longevity and Waters proprietary manufacturing process ensures unmatched batch-to-batch and column-to-column consistency for reproducible results. These new offerings complement Waters ACQUITY Protein BEH SEC columns and provide laboratories with the ability to seamlessly transfer methods from UPLC to HPLC using columns containing particles differing only in their size. The column is shipped with a vial of either the BEH200 or BEH450 SEC Protein Standard Mixture for column and LC System benchmarking, method development, or troubleshooting.   ]]> https://biospectrumindia.com/news/97/3900/agilent-to-shut-down-its-nmr-business.html https://biospectrumindia.com/news/97/3900/agilent-to-shut-down-its-nmr-business.html Fri, 17 Oct 2014 09:50:00 +0530 Agilent Technologies has announced that it is exiting its Nuclear Magnetic Resonance business due to its unmet growth and profitability objectives. "Today's announcement represents a difficult decision necessary to drive improved profitability," said Mr Mike McMullen, president and chief operating officer, and CEO-elect. He added, "The NMR team has been extremely dedicated and has made many excellent contributions. However, this action is a step in ensuring that our investments are placed on higher-value lifesciences, applied markets and diagnostics solutions that will continue to drive growth across the company." Agilent will stop taking new NMR system orders immediately, but the company will continue to meet customer commitments for orders in progress and for ongoing support contracts. Agilent will continue to provide service on all installed NMR systems. The company expects that this decision will eliminate about 300 jobs, mostly within the next 12 months in Yarnton, the UK and Santa Clara, California. To cover the cost of exiting this business, Agilent will take an approximate $72 million restructuring charge in the fourth quarter. It expects a $20-$30 million decline in revenues in fiscal year 2015 due to the NMR business closure, but a positive impact of about $10 million in operating profit in FY15.   ]]> https://biospectrumindia.com/news/97/5726/premas-biotech-gets-illuminas-best-distributor-award.html https://biospectrumindia.com/news/97/5726/premas-biotech-gets-illuminas-best-distributor-award.html Thu, 16 Oct 2014 11:14:54 +0530 Premas Biotech has been bestowed with the best distributor award 2014 for the Asian territory again at the maiden global distributor meeting held at Illumina Inc headquarters in San Diego. The company got the sales excellence award for achieving 147 percent of the allocated quota. Premas Biotech offers lifescience research solutions to various companies in India and abroad. Besides being a full fledged Contract Research and Manufacturing Services Organization (CRAMS), the Life Sciences division of the company has been also into the marketing of genome sequencing instruments. Premas has been the national distributor for Illumina for a while now. It has been able to successfully install an increased number of genome sequencing platforms in many key national institutes in India. Mr Praveen Gupta, executive director, Premas Lifescience, who attended the awards ceremony, expressed his delight and satisfaction to the BioSpectrum on being honored with this pretigious award for its renowned prinicpal company. It is important to note that Illumina got its first platform that is Bead Array installed at the Institute of Genomics and Integrative Biology (IGIB) in 2007 by utilizing the services of Premas Biotech. ]]> https://biospectrumindia.com/news/97/3374/covidien-s-oximeter-gets-us-fda-approval.html https://biospectrumindia.com/news/97/3374/covidien-s-oximeter-gets-us-fda-approval.html Thu, 16 Oct 2014 09:27:00 +0530 Covidien has announced that the Food and Drug Administration has given it 510(k) clearance for the Nellcor Portable SpO2 Patient Monitoring System (PM10N). This portable oximeter is equipped with home care and sleep study modes and complies with IEC 60601-1-11 standards for devices used in the home health care environment. The device is a part of the company's respiratory function monitoring portfolio, this convenient, handheld patient monitor is user-friendly and ideal for fast, accurate, motion-tolerant monitoring of pulse rate and blood oxygenation (SpO2). The Nellcor Portable SpO2 Patient Monitoring System's compact design and ability to perform in challenging conditions make it an ideal tool for multiple critical clinical screenings. "Covidien's new generation of portable monitors is easy to use and brings our proven pulse oximetry technology to patients inside the hospital, in health care facilities, and even in their own homes," said Mr Matt Anderson, vice president and general manager, patient monitoring, Covidien. He added, "Because our pulse oximetry technology relies on cardiac signals, it mitigates signal interference, offering caregivers peace of mind. They can count on Covidien to provide accurate patient data, even during difficult conditions. The development of this product exemplifies Covidien's dedication to enhance patient care, both inside and beyond the hospital."   ]]> https://biospectrumindia.com/news/97/5581/bangalore-india-bio-2015-to-be-held-in-feb-2015.html https://biospectrumindia.com/news/97/5581/bangalore-india-bio-2015-to-be-held-in-feb-2015.html Wed, 15 Oct 2014 18:13:00 +0530 This annual biotechnology (BT) event is organized by the Department of IT, BT and S&T, Government of Karnataka, Vision Group on Biotechnology and MM Activ Sci-Tech Communications. Eminent guests present at the curtain raiser were Shri S R Patil, minister for IT, BT and S&T, Planning and Statistics, Government of Karnataka; Dr Kiran Mazumdar-Shaw, chairperson, Karnataka's Vision Group on Biotechnology and CMD of Biocon; and Mr Srivatsa Krishna, IAS, secretary to Government, Department of IT, BT and S&T. Bangalore India Bio 2015 will consist of multi-track conferences, international trade show, distinguished lectures and talks, InterlinX biopartnering, bio excellence awards, bioquiz, and networking events. The trade show will have a special 'IT4BT Pavilion' to bring the IT and BT fraternity under one roof showcasing the latest technologies and to understand the industry requirements. The BIB is expected to witness about 100 exhibitors, 3000-plus business visitors, and international representations from more than 20 countries including the USA, France, Australia, Canada, Germany, Netherlands, Belgium, Korea, Taiwan, Malaysia and other Southeast Asian countries. The Bangalore India Bio 2015 will also allow young researchers to present their innovations through 'Poster Sessions - Walkway of Discovery'. For the first time, the event will also feature new sessions such as Top Guns Talks, Young Guns Roundtable, Global Biotech Conclave, and Secretaries Conclave. "The Prime Minister has initiated the 'Make in India' mission, which is about manufacturing and 'Swacha Bharat Abhiyan' dealing with cleanliness, hygiene and sanitation. In both these initiatives, biotechnology has a role to play. Through this, the government is keen to enact biomanufacturing and fermentation manufacturing, presenting India with enormous opportunities," added Dr Kiran Mazumdar-Shaw. "There are emerging opportunities where Bangalore-based companies are doing what it takes to become globally relevant in the area of biofuels and other aspects of biotechnology," Dr Mazumdar-Shaw further opined.   Dr Mazumdar-Shaw also opined, "The round table conference called 'Secretaries Conclave' will help share, discuss and deliberate on issues, coming up with meaningful outcomes of what they believe should be the roadmap. This event will be a platform for young entrepreneurs, venture capitalists, and angel investors offering a glimpse of happenings inside the biotech sphere." Speaking about Bangalore being the IT and BT start-up capital, Dr Mazumdar-Shaw emphasized that most biotech start-ups today are genomics-led. "Genomics is one area where India can play a leadership role. Bangalore is privileged with a powerful ecosystem for genomics, in both public and private sectors." She said that the major challenge for India now is making genomics cost effective. She added, "India stands for high science at low cost. This is what we need to leverage and excel at and find a rightful place in the global biotech arena." Dr Mazumdar-Shaw also said that knowledge about biomedical technologies is growing by leaps and bounds. "The biomedical area is a vibrant space and a large number of start-ups are seen in this area. By combining IT and BT aspects, new diagnostic tools are developed. It is an exciting time for entrepreneurs, investors, and also for big companies to further build on their critical mass," she concluded. Mr SR Patil felt that agri-biotech needs to be developed first since India is predominantly an agricultural nation. "India's economy is dependent on agriculture. Farmers are the backbone of our nation. Unless agriculture is developed, farmers will not be empowered to strengthen our economy," he explained.     ]]> https://biospectrumindia.com/news/97/7154/aiims-osaka-university-of-japan-sign-mou.html https://biospectrumindia.com/news/97/7154/aiims-osaka-university-of-japan-sign-mou.html Wed, 15 Oct 2014 14:54:00 +0530 AIIMS has inked a Memorandum of Understanding (MoU) with Japan's Osaka University to establish a collaborative research and development program for low-cost surgical devices. This initiative is a part of the joint statement issued by Prime Minister Mr Narendra Modi and Japanese Premier Mr Shinzo Abe, during Mr Modi's visit to Japan to enhance cooperation in the field of medical devices. AIIMS Director Mr M C Mishra said, "The primary objective of this collaboration is to develop novel instruments for surgical needs and affordable medical devices for universal health coverage (UHC). At present, the areas of special interest include development of instruments for minimal access surgery, which will also involve other branches of surgical disciplines in due course of time. The parties will seek opportunities to enhance cooperation in other allied areas of mutual interest," in a statement. "Doctors and researchers from both the nations will visit each other's country to identify true clinical needs and collaboratively develop affordable devices with appropriate performance. The 'UHC devices from Asia' will not only improve the health sector in Indian and other Asian countries, but will also help reduce medical expenditures in Japan and other advanced countries," said Mr Kiyokazu Nakajima, professor, Osaka University.         ]]> https://biospectrumindia.com/news/97/1180/ogt-named-best-medtech-dealmaker.html https://biospectrumindia.com/news/97/1180/ogt-named-best-medtech-dealmaker.html Wed, 15 Oct 2014 10:14:00 +0530 Oxford Gene Technology (OGT) has won the Best Medtech Dealmaker award 2014 at the Oxford Bioscience Network (OBN) awards. This is the second consecutive year that the company has won the award. The award recognizes OGT's acquisition of Cytocell, a leading provider of DNA technology for the detection of gene rearrangements related to inherited genetic disease and cancer, earlier this year. The acquisition enables OGT to increase its genomic medicine offering by enabling entry into the complementary and rapidly growing market for fluorescence in-situ hybridisation (FISH) products. Dr Jon Rees, CEO, OBN said, "The quality of nominees continues to rise year on year and compiling a shortlist and picking winners gets harder. The award of Best Medtech Dealmaker to Oxford Gene Technology reflects what has been a highly successful move for both OGT and Cytocell. To win this award twice in consecutive years makes a real statement about OGT's ambition, strong business model, and strategy." Mr Tim Hall, CFO, OGT said, "The acquisition of Cytocell represents our commitment to becoming a global leader in genomic medicine. We are very grateful to OBN for recognising the opportunity and the value of the deal. Cytocell's innovative DNA technology and strong brand has added to our portfolio of class-leading genomic technologies, and we are already seeing the benefits."   ]]> https://biospectrumindia.com/news/97/5115/zeiss-congratulates-nobel-prize-winners-.html https://biospectrumindia.com/news/97/5115/zeiss-congratulates-nobel-prize-winners-.html Tue, 14 Oct 2014 11:09:00 +0530 ZEISS congratulates Dr Eric Betzig, Dr Stefan Hell, and Dr William Moerner on winning the 2014 Nobel Prize for Chemistry. The scientists received the prize for the development of super resolved fluorescence microscopy. ZEISS is particularly excited about the recognition given to Dr Eric Betzig's work, which led to the development of the first commercially available super resolution microscope based on company's photo-activated localization microscopy (PALM) technology. The ZEISS ELYRA microscope system enables the imaging of fluorescence signals with resolution of just a few 10s of nanometers by sequentially activating and deactivating fluorescence proteins.   ]]> https://biospectrumindia.com/features/97/5126/has-osdd-fulfilled-its-promise.html https://biospectrumindia.com/features/97/5126/has-osdd-fulfilled-its-promise.html Tue, 14 Oct 2014 10:09:00 +0530 Open Source Drug Discovery (OSDD) - the pet project of Prof. Samir K Brahmachari, former director general (DG), was launched on September 2008. It introduced the concept of 'open source' to drug discovery, for the first time ever. Launched with the motto of 'affordable healthcare', OSDD tried to collectively aggregate the skills of researchers in academia, research laboratories, and industry to discover drugs particularly targeting neglected diseases. OSDD describes its objectives as follows: • To create a CSIR-led Team India Consortium with international collaboration to lead an open source drug discovery program.• To develop a novel comprehensive systems biology approach to generate a comprehensive interaction map of the pathogen (ongoing).• To discover and develop New Chemical Entities (NCEs) for Mycobacterium tuberculosis including drug resistant and latent tuberculosis. (First phase activity being carried out).• In the second phase, clinical trials will be undertaken.• To make  the new drug available as a 'generic' drug without IP constraints, available in the open, so that the industry anywhere in the world could manufacture and distribute, ensuring that the drug reaches patients at affordable prices. On its seventh anniversary, we analyse how many of its objectives have been achieved. Disease like TB, malaria, and Leishmaniasis etc., are poor man's diseases, thus there is no return on investment for pharma companies to invest in it, so are generally avoided by these companies. There is need for alternative strategies for discovering new drugs outside the pharma industry, with this objective and with the motto of affordable healthcare, CSIR launched OSDD program. OSDD first targeted the TB because of its high mortality rate. India is also dubbed as TB capital of the world claiming 1,000 lives daily and no new drugs have been discovered for the past several decades. OSDD tried to bring research on Mycobacterium tuberculosis, to the open sky so that researches across the world can share and collaborate, for finding the solution to this deadly disease. Towards this, a, Phase II B clinical trial for a new combination regimen for MDR-TB has been initiated.   The combination therapy, involving three drugs namely PA 824, Moxifloxacin and Pyrazinamide for MDR-TB, will be taken up for Phase II B clinical trials. OSDD has acquired the necessary approvals for conducting Phase 2B trial. The completed formalities include: regulatory clearance granted by DCGI, obtained the necessary drug entities, appropriate packaging and labeling, identification of labs for carrying out investigational studies during the trial, appropriate insurance regimen etc. Recruitment of patients for the clinical trials of combination therapy on MDR-TB patients is expected to start in a couple of months. The trial involves a 3 arm study using a combination of PA 824, Moxifloxacin and Pyrazinamide. The trial is soon to start at National Institute of Tuberculosis & Respiratory Diseases (NITRD, erstwhile LRS Hospital), New Delhi, informs Dr Sarala Balachandran, project director, OSDD. She added, "This novel combination has been in licensed from The Global Alliance for TB, a non-profit organization. CSIR-OSDD has the license to progress the combination through different stages of clinical trials. This new drug combination will be made available at an affordable cost without any royalty to the needy patients in the country." Funding Funding for clinical trial and OSDD's other activities is through CSIR (Ministry of Science and Technology, Government of India) the core funding body of OSDD is from the CSIR. In the 11th plan, Government of India has earmarked Rs 45.96 crore (about $12 million) for the project. This has been extended till March 31, 2015 with additional funding of Rs 838.00 lakh. For funding for the 12th plan EFC has been approved. The process for getting cabinet note approved is ongoing. Additionally, Sir Dorabji Tata Trust has awarded a grant to enable Council of Scientific & CSIR for operating TATA CSIR-OSDD Fellowship (TCOF) to support students who will participate in the process of 'crowd sourcing' as a method of research on open source discovery of drugs for neglected diseases like Tuberculosis (TB) and Malaria. The grant amounts to Rs 3 crore for a period of three years. "One of the significant achievements of OSDD includes leveraging the potential of crowd sourcing to reannotate the genome of Mycobacterium tuberculosis. The activity has been the largest crowd sourced activity till now and has been successful in actively involving the Indian student community at large. OSDD has also been successful in building up a host of open source facilities aiming to equip researchers with easily accessible resources to enable their research including facilities like Open Source Chemical Repository - OSDDChemat CSIR-CDRI and Open Screening Facility at CSIR-IICT along with open source Computational Resources for Drug Discovery," said Dr Sarala Balachandran. According to Prof. Samir K Brahmachari, "OSDD have made Indian students work together. Various labs across India are working together. It has created research opportunities for Indian students. 90 chem PI along with over 400 students are sysnthesing chemical molecule. Many other molecule re-discovered and are at various stage of development. In addition, we are now developing a system biology based computer modelling of an organism by which we can identify new ways of drug targets which are non-toxic. In addition, thousands of students have been trained." ''Another substantial attainment is building in-silico computational model of M-TB. Where we computationally modelled 1,152 reactions involving 890 genes i.e. one-fourth of the mTB gene with 961 metabolites in computer. The paper will be published soon, it will be first of its kind, commented Prof. Brahmachari. It has published 20 papers so far, as per OSDD's website. In the course of time, it has successfully collaborated with many international organisations, like medicine for malaria venture MMV; Royal Society of Chemistry (offers fellowships to OSDD students), The Systems Biology Institute, University of Indiana (PI-PI collaborations), University of Cambridge (the cambam collaboration, to validate the drug project/targets), DNDi (for Leishmaniasis research) and OSDD has currently entered into agreement with Global TB Alliance for developing PA-824 in India. Today 8,000 students across 130 countries are associated with OSDD. OSDD through its exclusive internships for women has attracted and promoted scientific temper in the women of this country. Mission 'affordable healthcare' OSDD's mandate was to discover new molecule whether that molecule will be taken up for trial is not its mandate, even development was not its mandate, however we made it a mandate in phase II of the study, for which we have not received any budget. With the leftover budget of the study, we are trying to develop some drug. So discovery part, yes, we are absolutely the best in the world. Development is a slow process, but we will try our best. Right now the only focus is to eradicate TB completely from India, to bring down the number of deaths to 100 as opposed to 1,000 at present. It will cross one milestone after the other. Its milestone will be fulfilled when eventually it will help in reducing the number of deaths. The objectives set for OSDD are met, commented Prof. Brahmachari. According to him, "OSDD is not a project. It is a movement started in India. CIR-led team. What started as an initiative, six years back is now a global phenomenon. I don't see today anybody in the pharma industry who has not heard this term OSDD". The biggest achievement of OSDD is in bringing the term, open source pharma. Now on similar lines, Australia has launched open source malaria and also, various researchers across the globe have come together for open source pharma. "It might not be 100 percent success, but we are way better than what we started." said Dr U C Jaleel, principle investigator, CSIR OSDD research unit. He added, "It is the first Indian system where many scientists are directly addressing the problem of TB. And also, it has created a whole new research ecosystem for drug development and made aware of the need for collaborative effort for drug discovery of the neglected diseases." Perhaps the biggest achievement of OSDD is the recognition of open source platform for drug discovery, so much so that Mr Matthew Todd (Associate Professor, University of Sydney) is coming to India, to write a book on OSDD. By and large, OSDD has evolved as a globalized platform and emerged as a major alternative for the drug development for neglected diseases. Since drug discovery is a long process, typically takes 10-15 years, hopefully in the years to come, it will launch a drug. My target is 2022, when at least we can introduce some medicines in the market, sums up Prof. Brahmachari.                     ]]> https://biospectrumindia.com/news/97/5642/medtronic-sued-by-a-shareholder.html https://biospectrumindia.com/news/97/5642/medtronic-sued-by-a-shareholder.html Mon, 13 Oct 2014 14:19:26 +0530 A Medtronic shareholder has allegedly filed a lawsuit against the company over its plan to pay $63 million in taxes, that senior executives and directors will incur in the proposed acquisition of Covidien, and order individuals getting the compensation to pay back the company. According to reports, Mr Marilyn Clark filed a shareholders derivatives lawsuit in the US District Court for Minnesota over the "wrongful decision to force the company to indemnify and reimburse Medtronic's officers and directors for millions of dollars of their personal tax liability in connection with an inversion merger that Medtronic entered into with an overseas entity, Covidien," according to court documents. "The multi-million dollar windfall tax reimbursement is wholly self-serving, counter to public policy, and harmful to Medtronic and its shareholders," Mr Clark said in a statement.   ]]> https://biospectrumindia.com/news/97/4495/us-fda-issues-medical-device-security-guidelines.html https://biospectrumindia.com/news/97/4495/us-fda-issues-medical-device-security-guidelines.html Sun, 12 Oct 2014 12:18:00 +0530 In an effort to bolster the security of medical devices, United States of Food and Drug Administration (US FDA) has published a new set of recommendations. The new standards suggests that manufacturers take into account cyber security risks as part of the design and development of a medical device. It has asked device makers to submit documentation to the FDA about identified risks and existing controls to mitigate those risks. The FDA also recommends that manufacturers submit their plans for the updation of existing operating systems and medical software. However, these new guidelines will not change the existing approval process or the time line for device approval, said the regulatory body. Dr Suzanne Schwartz, director of emergency preparedness/operations and medical countermeasures at the FDA's center for devices and radiological health said, "It is important for medical device manufacturers to remain vigilant about cyber security and to appropriately protect patients from those risks," in a statement.   ]]> https://biospectrumindia.com/news/97/5266/cci-nod-for-siemens-beckman-deal.html https://biospectrumindia.com/news/97/5266/cci-nod-for-siemens-beckman-deal.html Sat, 11 Oct 2014 11:45:00 +0530 The proposed acquisition of microbiology testing business of Siemens Healthcare and its subsidiaries by Beckman Coulter and its subsidiaries globally has received green signal form the Competition Commission of India (CCI), says reports. As per the deal Siemens India's microbiology testing business assets would be transferred from Siemens India to Beckman Coulter India. CCI believes that the proposed combination will not have any adverse effect on the competition in India. Beckman Coulter is a part of Danaher Corporation and is involved in manufacturing of biomedical laboratory instruments. "No subsidiary of Danaher Corporation including Beckman Coulter and Beckman Coulter India has any activities in the bacteriology and mycology testing market or even in the broader segment of microbiology in vitro diagnostics, in India. Therefore, it is observed that there is no overlap between the activities of the buyers in India and the microbiology testing business of Siemens India," CCI said in a statement.   ]]> https://biospectrumindia.com/interviews/97/6457/digital-health-innovation-has-been-growing-exponentially.html https://biospectrumindia.com/interviews/97/6457/digital-health-innovation-has-been-growing-exponentially.html Sat, 11 Oct 2014 10:13:00 +0530 1. What, in your opinion has been the breakthrough digital health technology in the world? This ones a tough one because in the recent past, digital health innovation has been growing exponentially not only from the west but also from countries where managing and curbing diseases has been the most difficult. 2. How has this industry mushroomed in the last few years? Over the past three years, the industry in US has seen a whopping 27 percent increase. According to Research firm, Park Associates, the industry was doing $1.7 billion in 2010 and it predicts to grow to $5.7 billion by next year. The industry has seen massive growth in chronic care monitoring or management, senior citizens care and health and fitness domain. 3. What does the government budget hold for digital health companies? So far India stands poorly in the Global digital health. The first step taken by the new government is charting the roadmap for inclusive Digital India. The finance minister has set aside Rs 500 crore for the propagation of broadband, IT, hardware manufacturing and special focus is on software development. This indirectly points out to digitalisation and more reach. Of course, keeping this in mind, it would be easier for digital health companies to reach remotest of the population and offer their services, however its will take some time to become reality but atleast there is a start. 4. How stringent are the regulations for this new industry of digital/smart healthcare? The regulatory bodies have become aware of the rising trend and increase in digital healthcare companies. As a matter of fact, FDA has issued a new guidelines to regulate mobile medical apps. They will apply the same risk-based approach to assure safety and effectiveness for other medical devices. 5. How has your company managed to overcome competition in this space?   We have not launched the product yet and its too early to answer this question. 6. Have the consumers in the world become more smart about healthcare choices and improving technology in this space? In 2012, 19 percent of the mobile smartphone owners had at least one health app and the downloads number is going to increase to 142 million by 2016. Moreover, 69 percent of the American adults are willing to communicate with their healthcare providers via email and 40 percent by mobile health applications. This explains the acceptance of health tech amongst the normal population. 7. What are the current trends in Digital Healthcare across the Asia? 1. Use of social media to spread awareness about communicable and non-communicable diseases by governments. 2. Mobile payments adoption by pharmacies and point of sale retailers. 3. Use of big data by companies to identify behavioural patterns in chronic care. 8. Please elaborate on the role of Digital Health in transforming healthcare. Prior to Digital health, insights on human health were only dependent on healthcare practitioners opinion and advice. The investigations were driven on doctors discretion which in turn was limited to human error however now with the digital healthtech/care advancing, there is a shift of power from doctor to the patient. Digital innovations make it possible for consumers to use portable devices to access their health parameters, monitor vital signs and get a better insight on their health profile. There is an increase in shift from populistic view to an individualistic profiles giving us better understanding on the genomic level. This has catapulted the success rate and chances of finding anomalies and coming one step closer to finding cures for incurable diseases, giving better insights on chronic management and better healthcare in total. 9. Give us your perspective on Digital Healthcare policies in India and around the globe. This would be a very descriptive answer depending on the comparison of the country/continent healthcare policies. In general, India's spent on healthcare is less than 4 percent and thus India ranks lowest in the global health rankings.       ]]> https://biospectrumindia.com/news/97/5295/eisai-merck-pfizer-join-accenture-to-build-rd-cloud-platform.html https://biospectrumindia.com/news/97/5295/eisai-merck-pfizer-join-accenture-to-build-rd-cloud-platform.html Fri, 10 Oct 2014 14:27:00 +0530 Eisai, Merck, and Pfizer have joined forces to build a standards-driven platform powered by Oracle hardware and software to help pharmaceutical companies simplify and speed drug development. Accenture Life Sciences cloud for R&D solution is a new IT platform offering a transformation of the R&D technology landscape. "We have helped these companies successfully improve trial efficiencies, cut trial costs and enhance the productivity of trial participants," said Accenture in a note. This cloud platform offers a forward-looking, transformation of the R&D technology landscape providing new ways to use data across the development lifecycle to bring life-enhancing products to patients faster. The cloud brings together multiple internal and external data sources across clinical, safety, regulatory and operational functions into a single analytics platform, creating actionable insights to accelerate drug development and improve patient outcomes. ]]> https://biospectrumindia.com/news/97/5111/perkinelmer-launches-new-alphalisa-surefire-ultra-assays.html https://biospectrumindia.com/news/97/5111/perkinelmer-launches-new-alphalisa-surefire-ultra-assays.html Thu, 09 Oct 2014 15:39:51 +0530 PerkinElmer has added to its product line with the launch of its AlphaLISA SureFire Ultra assays. These solutions are designed to reduce assay time by up to 50 percent and to improve the protein phosphorylation detection process.  With high sensitivity and a wide dynamic range to detect protein phosphorylation, even at low levels, the assays are quick and easy to run even with a minimal amount of sample. "PerkinElmer is committed to developing advanced solutions for screening virtually all types of samples while controlling the quality of therapeutic antibodies. Providing new assays that help improve the research and quality control process can lead to breakthroughs in the lab and development of new biotherapeutic treatments," said Mr Brian Kim, president, Lifesciences and Technology, PerkinElmer. The AlphaLISA SureFire Ultra assays use TGR BioSciences' CaptSure technology to eliminate antibody interference in the therapeutic antibody screening process. It is also ideal for other types of screening such as small molecule modulation, detection of low and basal levels of phosphorylation, and detection of phosphorylation in tissue lysates. It generates results in less than 2.5 hours with only one or two incubation steps and no washing. Researchers can analyse different endogenous or transfected targets in parallel, all on the same plate.   ]]> https://biospectrumindia.com/news/97/5093/nightingales-and-philips-partner-for-respiratory-care.html https://biospectrumindia.com/news/97/5093/nightingales-and-philips-partner-for-respiratory-care.html Thu, 09 Oct 2014 14:37:38 +0530 Bangalore-based speciality home care company, Nightingales has entered into partnership with global medical technology leader, Philips Healthcare, to provide specialized home respiratory care services to patients. These services will be made available in metros and semi-metros very shortly. Under the new partnership, Nightingales will take its speciality home services for respiratory distress patients to an advanced level by making respiratory gadgets like non-invasive ventilator (NIV) and oxygen concentrator from Philips, available to patients at their homes. Moreover, respiratory therapists and speciality nurses in pulmonology will be trained by Philips as per world class protocols to work in sync and provide the most advanced and effective treatment support to the patient. Mr Lalit Pai, CEO, Nightingales said, "This association marks a giant stride forward in home-based respiratory healthcare services offered in India. This partnership reflects Nightingales' focus on home-based chronic disease management and on providing patients a new avenue of care. Philips has a dedicated home care respiratory technology which will back the care protocols, and together we will strive to provide a new level of respiratory care at home."   ]]> https://biospectrumindia.com/news/97/5094/cognizant-acquires-digital-marketing-firm-cadient.html https://biospectrumindia.com/news/97/5094/cognizant-acquires-digital-marketing-firm-cadient.html Thu, 09 Oct 2014 14:31:23 +0530 Cognizant has announced that it has acquired Cadient Group in a deal worth $30 million. Cadient is a full-service digital marketing agency that serves a broad spectrum of lifescience companies in the pharmaceutical, biotechnology, consumer health, and medical device industries. As part of this acquisition, more than 100 digital specialists with expertise across brand strategy and planning, content development, user-centered design, multi-channel analytics, and digital, social and mobile marketing will join Cognizant. This acquisition also brings to Cognizant digital assets and intellectual property of Cadient including Reveal, an insights and analytics platform; Immerse, an experiential marketing platform; and OneVoice, an advocacy campaign management platform. "The lifesciences industry is undergoing structural disruption as marketing services enable new digital ways for companies to engage with patients and providers and create compelling user experiences," said Mr Shankar Narayanan, vice president and global markets leader of the lifesciences practice at Cognizant. He added, "We welcome Cadient's digital specialists to the Cognizant family and are confident that our combined capabilities and digital assets will help both lifesciences and broader healthcare companies gain a competitive advantage by managing the information that surrounds organizations, processes, products, and people what we call Code Halos." Mr Stephen Wray, president and CEO, Cadient Group said, "Becoming a part of Cognizant uniquely positions us to deliver integrated solutions to lifescience marketing and sales teams around the world. Clients will now have enhanced access to the best creativity and craftsmanship of a design firm combined with the best-in-class management and execution capabilities of a large consulting and technology firm to produce superior customer engagements at the brand and enterprise level. Together, we are ideally positioned to deliver on this promise." The terms of the transaction were not disclosed.       ]]> https://biospectrumindia.com/features/97/6919/top-20-biosupplier-survey-21-25.html https://biospectrumindia.com/features/97/6919/top-20-biosupplier-survey-21-25.html Wed, 08 Oct 2014 15:22:49 +0530 21: SISCO research LaboratoryESTABLISHED in 1975, it is the first Indian company specialized in the supply of Bio-chemicals and Organic Reagents. The company has performed very well in FY14, having increased its range of highly purified diagnostic reagents, biochemical probes, molecular biology reagents, and nano compounds. The company has continued to widen its range of proteins, carbohydrates, ionic liquids, specialty bioreagents, graphene based nano materials, thin and multi-walled CNT's, and a high range protein markers for research. 22: Biohouse SolutionsTHE BIOHOUSE Solutions serves healthcare institutions, lifescience researchers, clinical laboratories, pharma, and biotech industry. The company has created a separate vertical for instrumentation and increased the strength of its technical team. It has signed up with four European multinationals. During the year, it has launched Thermo instrumentation range products and Roche products in Delhi-NCR market. The company plans increased thrust on a pan India presence with enhanced focus on South India. 23: eDiscovery AutomationeDISCOVERY Automation was incorporated in the year 2012. It is a progressive laboratory automation and automated analyzers distribution company providing world class systems and solutions from reputed overseas manufacturers for R&D, quality control, and industrial process. For FY 2013-14, it recorded revenue of Rs 4 crore, up by Rs 3 crore from its last FY 2012-13, which stood at Rs 1 crore. 24: Bio-Age Equipment & ServicesBIO-AGE Equipment and Services is involved in manufacturing, sales, and services in the area of industrial biotech products like fermenters or bioreactors up to 10,000 liters capacity, water purification systems and other biotechnology equipment. The major foreign principals include Grant Instruments,UK; Picodrop, UK; and E-Chrom Tech, Taiwan. The company is directly responsible for the sale and after sale services for these products in India. It plans to launch UF, RO, NF filtration products in the future. 25: 3B Blackbio Biotech IndiaTHIS is an Indo-Spanish joint venture company of Kilpest India Ltd and bio tools B&M Labs, Madrid,Spain. It provides integrated solutions in areas of molecular diagnostics, pharmacogenomics and life sciences R&D. The company has recently launched the bheacterial sepsis identification and fungal sepsis identification kit through pyrosequencing in six hours. It has also introduced real time PCR based affordable kit for infectious disease and oncology parameters.   ]]> https://biospectrumindia.com/news/97/5028/phenomenex-introduces-novum-sle.html https://biospectrumindia.com/news/97/5028/phenomenex-introduces-novum-sle.html Wed, 08 Oct 2014 15:09:23 +0530 Phenomenex introduces Novum Simplified Liquid Extraction (SLE), a novel, synthetic alternative to traditional diatomaceous earth SLE (also known as supported liquid extraction) products and a simplified approach to traditional liquid-liquid extraction (LLE). As the first of its kind, the synthetic Novum SLE sorbent (patent pending) can be used with the same procedure as traditional SLE sorbents while delivering improved lot-to-lot reproducibility. Novum SLE simplifies the liquid-liquid extraction process by eliminating manual steps and reducing solvent consumption. SLE also delivers higher sample recovery than liquid-liquid extraction methods by eliminating analyte loss due to emulsions that can form at the interface of the two liquid phases. Novum SLE is available in 96-well plates. It feature long-drip tips that extend into the wells to reduce contamination and are available in two different loading capacities - 200 µL and 400 µL. "By manufacturing the sorbent, we are able to provide improved lot-to-lot consistency, which is extremely important for labs using validated methods that rely on reproducible results," explains Ms Erica Pike, brand manager, Phenomenex. She added, "SLE requires just 15 minutes to process a 96-well plate, compared to 25 minutes for other liquid extraction methods. The faster processing time, combined with reduced analyte loss, translates to big advantages for higher throughput labs." Phenomenex Novum SLE can also be automated using a liquid handler, further improving throughput.   ]]> https://biospectrumindia.com/interviews/97/4185/we-have-the-confidence-to-manufacture-in-india.html https://biospectrumindia.com/interviews/97/4185/we-have-the-confidence-to-manufacture-in-india.html Wed, 08 Oct 2014 14:30:00 +0530 Q: Please tell us about the recent developments at DSS Takara Bio India (DTI)?We are now manufacturing molecular biology reagents including PCR and RT PCR in India which happily is in line with the 'Make in India' campaign of the Prime Minister, Mr Narendra Modi. We have made it happen in collaboration with the Japanese company, Takara Bio. During our course of work, we have learnt a great deal about accuracy, consistency, and very strict quality control (QC) measures from our Japanese partner. It has been a great learning process and which we have been able to maintain and implement successfully in our manufacturing unit. It took more than one and half years to put up the infrastructure that has been rolled out now. Now, we have got the confidence to manufacture in India. The products being made here include Taq, SYBR, and other RT PCR enzymes for the world market. While we are exporting to Japan, from where these are getting distributed across the globe, the same products are also being marketed in the Indian domestic market as well. With the same parameters for different markets, the products we have just launched in India have been well received. We look forward to produce many more of such products from 2015 onwards. Q: What gives you the confidence despite competition from already established brands in India?Takara Taq is already extremely popular with clients as it enjoys an established credibility. It has been seen that the cheap tag doesn't go down well with clients in India and hence we offer cost effectiveness. It means an affordable product for our clients which not only comes at a lesser price but also with an equally good performance. The rates will be 30-40 percent lesser than known brands and we took two years to ensure that the QC is not compromised. The QC protocol goes to Japan for verification and there are three batch tests for any product that is sent. We have already launched RNAiso and DNA ladder, apart from receiving QC approval for Ex Taq, which we are launching shortly. I am delighted to mention that DSS is a pioneer in partnering with a Japanese company to produce molecular biology reagents in India.Q: Apart from molecular biology, how has been DSS ImageTech's performance in microscopy and diagnostics? Since a few products are complicated to make, we are at the moment going to be restricted to molecular biology reagents for research and diagnostics. As far as marketing of diagnostic products is concerned, our relationship with Abbott has gotten stronger. We have received an order on HIV diagnostics from National Aids Control Organization (NACO). Also, there is lot of discussion on Hepatitis in India which as per reports, is considered more active threat than HIV. We are bringing in a platform from Abbott, who have 40 years of experience in the area. It has launched the MTB, HPV, HIV, Hepatitis diagnosis on a single platform. This is the way in which we are going to be a one stop solution for all molecular diagnostic requirements of various diseases. Despite takeover by Agilent Technologies, Dako's products, mostly cancer diagnostics, are being marketed by us. They still decided to go through our network rather than their own. It speaks volumes about our credibility in the market. We conduct lot of training programs in India and neighbouring nations such as Nepal. The FISH technique solution from Abbott which we launched at BHU saw the presence of 32 cancer experts. While being a commercial organization, we are still within our limits trying to educate people about interpretation of results, making them more aware about usage of tools to fine tune research.We work in major two areas in molecular diagnostics. One is infectious diseases, diagnosis of HIV, Hepatitis, Papilloma virus, and MTB through Abbott. Another is cancer diagnostics for which FISH by Abbott and immunohistochemistry through Dako(Agilent).In microscopy, we have done extremely well through our tie up with the Olympus. However, last two years have not been so encouraging. We had setbacks with microscopy due to loss of one of our top executives. Q: How has your financial performance been in the last one year? What is your overall strategy to boost prospects?The overall revenue of DSS Group during the FY 2013-14 was Rs 195 crore as compared to Rs 171 Crore recorded as turnover in the previous fiscal year. The R&D section of DSS has been recognized by DBT and at present a good number of activities are in progress there. We are in collaboration with Delhi University, developing a high end test in a project funded by the DBT. DSS is not just a marketing company but focus has been on innovation and strategy being joint ventures.Q: How do you look at government policies for the sector? What is required? Food and agriculture offer immense potential. We need to create enough opportunities and equally right policies for that. There has to be a pragmatic policy for preclinical trials and genetically modified crops. We can't delay the decisions as  meetings after meetings in this direction have failed to elicit any favourable response. There is a dire need for the people in science to take charge of these issues.       ]]> https://biospectrumindia.com/news/97/4843/approval-for-philips-digital-health-applications.html https://biospectrumindia.com/news/97/4843/approval-for-philips-digital-health-applications.html Wed, 08 Oct 2014 12:48:36 +0530 Royal Philips has announced that its eCareCoordinator and eCareCompanion telehealth applications have received 510(k) clearance from the US Food and Drug Administration (FDA). A part of Philips Hospital to Home's suite of telehealth programs, these applications are focused on patient care within the home.They are the first clinical applications to be available through a cloud-based digital health platform. eCareCoordinator supports population health management by providing clinicians with a daily review of their patients, allowing them to prioritize and adjust care plans or intervene as needed. It further gives them real-time access to both objective health data like vital signs, blood pressure, and weight a well as subjective responses collected via health questionnaires and other communications. The eCareCompanion application serves as a patient portal, driving patient engagement and self-management. The personalized application is accessed via a tablet, and allows patients to answer questions about their health and enter requested measurements. It enables them to stay connected with their care teams. Its ability to connect with medical devices such as a weight scale, oximeter, blood pressure meter, and medicine dispenser, offers a deeper insight into a patient's health. The application also proactively reminds them of pre-assigned health tasks like taking medications, to encourage adherence and better outcomes. "The FDA clearance of the Philips eCareCoordinator and eCareCompanion applications marks the first major step in realizing our vision for a digital health platform that seamlessly integrates data to transform the way we deliver patient care," said Mr Jeroen Tas, CEO, Philips Healthcare Informatics Solutions and Services. He added, "These applications address both clinician and patient needs, providing clinicians with better access and analysis around patient data while empowering patients to manage their own health with direct access to care teams. The deeper insights into patient conditions will help enable more efficient and cost-effective care for improved outcomes."   ]]> https://biospectrumindia.com/news/97/7107/mike-mcmullen-to-be-agilents-new-ceo-.html https://biospectrumindia.com/news/97/7107/mike-mcmullen-to-be-agilents-new-ceo-.html Tue, 07 Oct 2014 13:25:00 +0530 Agilent Technologies recently announced that Mr Mike McMullen, senior vice president, Agilent, and president of the company's Chemical Analysis Group (CAG), will succeed Mr William (Bill) Sullivan as CEO on March 18, 2015. Mr Sullivan will remain as an advisor through the end of the company's fiscal year, Oct 31, 2015, when he will retire. As a first step in the transition, Agilent's board of directors has appointed Mr McMullen aged 53 as president and chief operating officer, effective immediately. "This transition is the culmination of our succession planning, and comes at a time of strength as Agilent begins to deliver the shareholder benefits of the recent spinoff of its electronic measurement business," said Mr James Cullen, chairman of Agilent's board of directors.  As president and COO, Mr McMullen will be responsible for the company's businesses, CAG and Life Sciences and Diagnostics Group, Order Fulfillment and the newly formed Agilent CrossLab Group, as well as the global organization that houses IT, workplace services, global sourcing, and logistics. Mr McMullen joined Hewlett-Packard Co. in 1984 as a financial analyst in the Analytical Products Group. Since then he has served in various senior management positions. As president of Agilent's Chemical Analysis business, he was responsible for company-wide organization in the chemical and energy, food and environmental markets, as well as the services and consumables business for CAG and Life Sciences. "It is an honor to have been asked to lead Agilent and our very talented teams into the future," Mr McMullen said. "Agilent is a great company that is well positioned to tap new opportunities in life sciences, diagnostics and applied markets. Our strategy is compelling and will create value for our shareholders. I am excited about working with the teams to execute on our plans." "Our focus remains where it has always been-on our customers, supporting their everyday goals in the laboratory as well as their big, world-changing breakthroughs," he said. Commenting on the announcement, Mr Deepak Rawal, country general manager, Agilent Technologies India said, "Mr Bill Sullivan has done a tremendous job evolving Agilent and making it a focused life sciences, diagnostics and applied markets company. I now look forward to Mike leading us to the next phase in Agilent's journey. He is an inspiring leader and Team India is fully geared to support this exciting new chapter at Agilent." ]]> https://biospectrumindia.com/news/97/5032/philips-loses-467-mn-patent-verdict-to-masimo.html https://biospectrumindia.com/news/97/5032/philips-loses-467-mn-patent-verdict-to-masimo.html Mon, 06 Oct 2014 14:35:00 +0530 Philips initially denied the infringement but now surprisingly has admitted to the act. The case was filed in 2009 by Masimo in the US District Court for Delaware. Later, Royal Philips also filed a counter-claim against it. "We are very disappointed in the verdict of the jury and surprised by the magnitude of the proposed award," said Mr Frans van Houten, CEO, Royal Philips in a statement. "Philips intends to pursue all avenues of appeal of this verdict at both the district and appellate courts in the US." Last month, Royal Philips announced its landmark decision to split itself into two different companies, separating its lighting business from its amalgamated healthcare and consumer electronics divisons. This judgment may cause damage to its healthcare product brand value.  ]]> https://biospectrumindia.com/news/97/5391/a-mechanized-hand-from-an-oregon-uni-research-team.html https://biospectrumindia.com/news/97/5391/a-mechanized-hand-from-an-oregon-uni-research-team.html Fri, 03 Oct 2014 11:04:00 +0530 Researchers at Oregon State University have developed a mechanized human hand that will help facilitate movement and restore the gripping capability of hands following nerve damage. It is said to be one of the first instruments created that could improve the transmission of mechanical forces and movement inside the body. The device was tested in cadaver hands. The new mechanism is a passive technology using a basic pulley that when implanted within a person's hand will allow for a more natural grasping function with less use of muscle energy. "This technology is definitely going to work and it will merge artificial mechanisms with biological hand function," said Mr Ravi Balasubramanian, an expert in robotics, biomechanics, and human control systems, and assistant professor at the Oregon State University. New research demonstrates how the mechanism developed for this problem can produce more natural and adaptive flexion of the fingers needed for grasping. The force needed to close all four fingers around an object was reduced by 45 percent, and the grasp improvement on an object reduced slippage by 52 percent. "The long-term potential of such mechanized assistance is profound. In some cases, it may indeed be possible to create joints or limbs that mechanically function as well or better than they did originally," said Mr Balasubramanian. Technology such as this may offer new options to people who have lost the use of their hands due to nerve trauma, and ultimately be expanded to improve the function of a wide range of damaged joints in the human body, the researchers said.   "The impact can be devastating, since grasping is a fundamental aspect of our daily life. The surgery we are focusing on is commonly performed in the military on people who have been injured in combat," Mr Balasubramanian added. The findings are reported in the journal Hand.   ]]> https://biospectrumindia.com/news/97/5353/gsk-commits-5m-to-develop-bioelectronics.html https://biospectrumindia.com/news/97/5353/gsk-commits-5m-to-develop-bioelectronics.html Fri, 03 Oct 2014 10:10:00 +0530 GlaxoSmithKline has launched a $5 million Innovation Challenge Fund (ICF) to advance open-access technology in the bioelectronics space. The fund will support academic groups and small companies who want to develop solutions for GSK's Bioelectronics Innovation Challenge, which was developed by a group of leading scientists from around the world. This funding program is in addition to GSK's prior commitment of a $1 million, announced in December 2013, to be awarded to the team that first solves the challenge. Bioelectronic medicine is a relatively new scientific field which could result in a new class of treatments that would not be pills or injections but miniaturized, implantable devices. To encourage open innovation in the field of bioelectronics medicine, any tools and technologies that come from the ICF funded work and the Innovation Challenge's winning entry will be made freely available to the global research community. The intention is that this will foster an environment of collaboration between researchers from different institutions and accelerate the development of a new generation of medicines. "We see the development of bioelectronic medicines as a collaborative process that will only be successful with the combined skills of world-leading engineers, physiologists, neuroscientists, and informatics experts," said Mr Moncef Slaoui, chairman of global R&D and vaccines at GSK in a statement.   ]]> https://biospectrumindia.com/news/97/5573/agilis-strengthens-its-advisory-board.html https://biospectrumindia.com/news/97/5573/agilis-strengthens-its-advisory-board.html Thu, 02 Oct 2014 10:06:00 +0530 Agilis Biotherapeutics has announced the addition of Mr James E Darnell to its Scientific Advisory Board.  Dr Darnell is Vincent Astor Professor Emeritus of the Laboratory of Molecular Cell Biology at the Rockefeller University and a pioneer in RNA research. Dr Darnell's scientific research has been recognized worldwide by numerous awards and memberships in honorary societies for fundamental discoveries in the molecular biology of mammalian RNA and in cytokine control of transcription. "We are excited to welcome Dr Darnell, an extremely distinguished and accomplished scientist, as a scientific advisor to the company," said Dr Mark Pykett, president and chief executive officer, Agilis. He added, "Dr Darnell brings great experience and expertise that we believe will be immensely valuable to Agilis' research as we optimize our genetic medicines for the treatment of rare diseases." "I am pleased to join Agilis and hope my experience will aid the quest to transform the treatment of Friedreich's ataxia and other diseases that result from abnormalities in or lack of specific proteins," said Dr Darnell. Dr Darnell is a member of the American Academy of Arts and Sciences, The American Philosophical Society, the Royal Society, and the Royal Swedish Academy of Sciences. He has received numerous awards, including the National Medal of Science from the White House for lifetime achievement in the field of scientific research.   ]]> https://biospectrumindia.com/news/97/4314/ge-gsk-to-work-on-commercial-oncology-testing.html https://biospectrumindia.com/news/97/4314/ge-gsk-to-work-on-commercial-oncology-testing.html Wed, 01 Oct 2014 15:28:49 +0530 GE Healthcare has announced an agreement between its affiliate, Clarient Diagnostic Services (Clarient) and GlaxoSmithKline (GSK). The collaboration aims to improve access to diagnostic testing for cancer patients by establishing a network of clinical laboratories to identify genetic mutations associated with different tumour types. This will help GE develop a broader laboratory and data analytics service that will enable better efficiency in the healthcare market related to oncology precision medicine. This will be made available as a subscription-based service and will be operated by GE Healthcare. "Our arrangement with GSK will enable us to leverage our clinical, technical and quality management expertise to credential laboratory partners worldwide. This global network of high quality diagnostic capability can be leveraged with confidence by all pharmaceutical companies in search of rigorously standardized oncology diagnostic services and data," said Ms Cindy Collins, CEO, Clarient. Under the terms of the agreement GE Healthcare, through its Clarient affiliate, will initially use its clinical laboratory, pathology, and genomics expertise, to certify laboratories and generate diagnostic data on metastatic melanoma patients. "Through this agreement, we hope to better address the variability in access and quality of diagnostic testing which is a common problem seen with targeted oncology therapies and related companion diagnostics globally" said Mr Jonathan Pan, head of Oncology Companion Diagnostics and Disease Strategy, GSK. He added, "The commercial testing infrastructure created through this collaboration will enable advanced diagnostic solutions that should improve how patient care is delivered, where the certified laboratories are operational."     ]]> https://biospectrumindia.com/news/97/5329/agilent-technologies-inks-pact-with-university-of-toronto.html https://biospectrumindia.com/news/97/5329/agilent-technologies-inks-pact-with-university-of-toronto.html Wed, 01 Oct 2014 15:21:04 +0530 Agilent Technologies has announced a collaboration with the University of Toronto's Donnelly Center for Cellular and Biomolecular Research to produce a comprehensive metabolomics multiple-reaction monitoring (MRM) library and methodology, using Agilent's Infinity 1290 UHPLC and 6460 triple quadrupole mass spectrometry system. "We are impressed with Agilent's mass spectrometry instruments and software solutions. We look forward to working together to enable use of LC-MS metabolomics by a larger scientific audience," said Professor Adam Rosebrock, who is collaborating on this project with Dr Amy Caudy, both principal investigators from the Donnelly Center. The library, coupled with Agilent's MassHunter software, will provide scientists with a robust LC/MS solution to accelerate the quantification of hundreds of metabolically important compounds for cell biology and disease research. "Routine metabolite quantification is an essential component for building a better understanding of how diseases such as cancer and diabetes modify metabolic pathways. We are honored to work with Dr Rosebrock and Dr Caudy to bring this powerful solution to the scientific community and help advance research efforts in the area of quantitative metabolite measurement," said Mr Steve Fischer, market director for Agilent's Life Science Research Division. This new metabolomics MRM library will be added to Agilent's existing collection of MRM libraries, which address a variety of applications including pesticides, veterinary drugs, forensics, and toxicology.   ]]> https://biospectrumindia.com/news/97/4963/horizon-discovery-acquires-sage-labs-for-48-mn.html https://biospectrumindia.com/news/97/4963/horizon-discovery-acquires-sage-labs-for-48-mn.html Wed, 01 Oct 2014 14:30:00 +0530 As part of its strategic plan to be the world leader in Gene-editing, Horizon discovery has announced the acqusition of Sage labs, a US-based maker of advanced in vivo transgenic models for use in preclinical research. Horizon will be paying $16 million in cash and aboout $32 million in new issue shares. Sage labs was formerly a part of Sigma-Aldrich, before being bought by Telegraph Hill Partners in 2013. The company has over 50 employees and 43,000 sq ft of excellent facilities. With this acqusition, Horizon adds to its extensive portfolio of Intellectual property of CRISPR, rAVV and gains exclusive access to ZFN for in-vivo model generation. The company will also be expanding its range of genetically engineered preclinical models used ot develop drugs for specific genetic diseases like cancer. The combined gene-editing platform will make the global player the go-to for innovative solutions in personalized medicine and treatment. It will also open up new market areas wherein Sage has a strong presence and which would add to the company's already exisiting business lines. Horizon, on its part will focus on expanding Sage's mostly US-based market to Europe and Japan. The acqusition is to be completed tomorrow, 2 October, 2014. Dr Darrin M Disley, CEO of Horizon Discovery Group, commented,"The acquisition positions Horizon as the world-leader in gene-editing and at the forefront of technological advances in the field of translational genomics. The consolidated offering significantly strengthens Horizon commercially, allowing us to offer product, service and R&D programs to customers engaged at every stage of translational genomics and personalized medicine research from sequence to treatment."   ]]> https://biospectrumindia.com/news/97/4898/phenomenex-adds-new-products-to-its-core-shell-line.html https://biospectrumindia.com/news/97/4898/phenomenex-adds-new-products-to-its-core-shell-line.html Tue, 30 Sep 2014 17:10:42 +0530 Phenomenex has added an advanced line of HPLC columns to its core-shell line, the Kinetex EVO C18. These columns are said to be made of a patented organo-silica grafting process that utilizes uniform stabilizing ethane cross-linking to create a unique selectivity and ultimately, pH stability from 1-12. The new line delivers improved results, increased productivity and reduces costs as compared to other traditional HPLC media. The pH stability makes them ideal for use in open access labs for analytical and preparative methods. "It's very exciting to witness first-hand the incredibly positive customer reaction now that the guarantee of core-shell performance at virtually any pH range is finally here," explained Mr Simon Lomas, brand manager, Phenomenex. "Now scientists can utilize Kinetex 5 µm EVO C18 columns to easily improve HPLC or PREP LC results without the pH restrictions of other core-shell products or the performance limitations of traditional hybrid and polymer columns." The 5 µm are ideal for running long term compressions. Additional core shell particles are to be introduced soon. ]]> https://biospectrumindia.com/news/97/4863/ges-discovery-iq-gets-us-fda-nod.html https://biospectrumindia.com/news/97/4863/ges-discovery-iq-gets-us-fda-nod.html Tue, 30 Sep 2014 16:05:40 +0530  GE Healthcare has announced the United States of Food and Drug Administration (US FDA) 510(k) clearance of its Discovery IQ PET/CT (Positron emission tomography-computed tomography) system. Its outstanding image quality and intelligent quantitation help physicians deliver the best possible  outcomes to patients. This innovative new tool provides varied benefits to doctors across the cancer care continuum from diagnosis and staging to treatment planning and assessment. Discovery IQ with Q Clear technology is designed to provide more accurate quantitation (SUV mean) with excellent image quality (SNR) for small lesion detection, fast, and efficient reading, and a confident diagnosis. It delivers the highest NEMA (National Electrical Manufacturers Association) sensitivity (up to 22 cps/kBq) and the largest axial field-of-view (up to 26 cm) compared to other market leading PET/CT equipment. "By 2020, it's estimated that 50 percent of people will develop cancer at some point in their lives and we also know that currently, approximately 70 percent of cancer patients do not respond to their initial chemotherapy treatment," said Mr Wei Shen, general manager of GE Healthcare PET/CT. He added, "I am excited about the recent FDA clearance of Discovery IQ, which will help physicians achieve their primary mission of delivering the best possible patient outcomes. And, by making Discovery IQ mobile-ready, we engineered it to be accessible to more patients in more places, allowing for high-performance PET/CT clinical care to whoever needs it." GE Healthcare's new Q Clear technology is a critical component of Discovery IQ.   ]]> https://biospectrumindia.com/news/97/4871/leica-to-set-up-a-center-of-excellence-at-yale.html https://biospectrumindia.com/news/97/4871/leica-to-set-up-a-center-of-excellence-at-yale.html Tue, 30 Sep 2014 15:38:32 +0530 Leica microsystems, a global player in scientific instruments, in collaboration with Yale University,  is to set up a center of excellence at the university's west campus. This new center will provide researchers access to the latest instrumentation technology, updated regularly by Leica, they will work towards developing novel imaging technologies. Housed in a new building, this new facility will give Leica access to world class research. The University has invited scientists to be a part of the opening cermony on the 20-21, October, 2014. "We are extremely excited to embark on this journey of discovery with Yale University as our first such partnership in the USA," said Mr Doug Reed, general manager of Leica Microsystems, North America. "This cooperation will provide some of the best scientific minds access to imaging tools previously out of reach, plus allow Leica Microsystems ready access to new ideas from outstanding scientific leaders, which will be used to guide development of tomorrow's innovations."   ]]> https://biospectrumindia.com/news/97/4809/labelling-mandatory-for-medical-devices.html https://biospectrumindia.com/news/97/4809/labelling-mandatory-for-medical-devices.html Mon, 29 Sep 2014 16:04:50 +0530 The Union health ministry has revised rule 109A of the Drugs and Cosmetics Rules (D&C) to make labelling of medical devices mandatory in the country. The ministry said in a notification that the particulars will be printed in indelible ink on the label or sticker on the shelf pack of the medical device. According to the ministry, the label should carry a proper name of the medical device; the details necessary for the user to identify the device and its use; the name of the manufacturer and address of the manufacturing premises where the device has been manufactured; the correct statement of the net quantity in terms of weight, measure, volume, number of units, and the number of the devices contained in the package shall be expressed in the metric system; and the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product. Also, it should provide, wherever required, an indication that the device contains medicinal or biological substance; any special storage or handling conditions applicable to the device. It should label the device, if the device is intended for single use; to overprint on the label of the container, the words "FOR CLINICAL INVESTIGATION ONLY", if the device is intended for clinical investigation; and to overprint on the label of the device, the words "Physician's Sample--Not to be sold", if a medical device is intended for distribution to the medical professional as a free sample. The label of a medical device should provide, except for imported devices, the manufacturing licence number.       ]]> https://biospectrumindia.com/news/97/4774/stemcell-technologies-receives-winn-support.html https://biospectrumindia.com/news/97/4774/stemcell-technologies-receives-winn-support.html Mon, 29 Sep 2014 15:40:59 +0530 Stemcell Technologies has received $949,500 from the Western Innovation (WINN) Initiative to develop tools and assays for three-dimensional (3D) cell culture. The project is led by Dr Steven Woodside, director of particle chemistry and engineering, and Dr Eric Jervis, principal scientist, and builds on company's extensive experience in developing culture systems and specialised cell culture media for lifescience research. The 3D cell culture platform mirrors the environment experienced by cells in the body, and so provides an improved physiological relevance for many areas of research and drug development, including cancer research, cell therapy, drug screening, toxicity testing, and tissue/organ engineering. The development of a convenient and robust 3D culture system is critical for the advancement of research in these important fields. Studies based on 3D culture are more predictive of disease states and drug responses, and enable more mechanistically accurate modelling of the target tissue. "We are thrilled to have received the support of the Western Innovation Initiative and are confident that the project will accelerate lifescience research and facilitate the development of novel drug formulations," said Dr Allen Eaves, CEO and president, Stemcell Technologies.   ]]> https://biospectrumindia.com/news/97/4766/ge-healthcare-launches-a-new-chromatography-system.html https://biospectrumindia.com/news/97/4766/ge-healthcare-launches-a-new-chromatography-system.html Mon, 29 Sep 2014 15:35:07 +0530 GE Healthcare Life Sciences has added a new product to its Capto platform of high-performance chromatography media portfolio, Capto S ImpAct. It is a strong cation exchanger for purifying monoclonal antibodies (MAbs) and a wide range of other biomolecules. Capto S ImpAct offers both high binding capacity and high resolution even at high sample loads. The high-flow characteristics of the Capto base matrix enable excellent pressure-flow properties. The small bead size for high resolution, in combination with the novel extended-surface ligands, support high dynamic binding capacity at high sample loads. The ability to run at both high flow rates and bed heights have been combined with these attributes to increase productivity and flexibility in process design. Large operational window of flow rates and bed heights for easy optimisation and scale up, high productivity, cost-efficient manufacturing, security of supply and a comprehensive regulatory support are some of the key benefits of Capto S ImpAct. It is available in different bulk sizes as well as in many prepacked formats such as PreDictor96-well filter plates, PreDictor RoboColumn, HiTrap, and HiScreencolumns.     ]]> https://biospectrumindia.com/news/97/4738/horizon-signs-msa-with-us-based-firm-for-1-2-million.html https://biospectrumindia.com/news/97/4738/horizon-signs-msa-with-us-based-firm-for-1-2-million.html Mon, 29 Sep 2014 10:54:44 +0530 Horizon diagnostics has signed a Master Services agreement with a US-based global pharma company to help in the development of companion diagnostics for novel, genetically-targeted cancer medicines, according to a company press release. As per the agreement, for the first project, Horizon diagnostics has to produce genetically defined cell lines and related gDNA and FFPE standards to the tune of $1.2 million. Dr Darrin M Disley, chief executive officer of Horizon Discovery Group plc, commented: "This is a highly significant deal for our reagent products business and demonstrates the potential of this business to contribute substantial growth to the Group in 2014 and beyond. We look forward to working closely with our new partners."   ]]> https://biospectrumindia.com/news/97/4682/skin-like-wearable-device-monitors-health-24-7.html https://biospectrumindia.com/news/97/4682/skin-like-wearable-device-monitors-health-24-7.html Sun, 28 Sep 2014 11:30:00 +0530 Scientists at the Northwestern University and University of Illinois have developed a new wearable device that can monitor specific properties of the heart and the skin. The devices is a wearabale skin friendly technology that can be worn 24/7 for around-the-clock health monitoring. The wireless technology used thousands of tiny liquid crystals on a flexible substrate, to sense heat and monitor cardiovascular issues and alterations in skin hydration levels. The device measures the transient temperature change at the skin's surface to determine blood flow rate, which is of direct relevance to cardiovascular health and changes in moisture levels on the skin. Mr Yonggang Huang, senior researcher, said, "Through this device we have demonstrated the relevance of technology to basic medicine. The device is an array of up to 3,600 liquid crystals with 3,600 temperature points, each half a millimeter square, laid out on a thin, soft and stretchable substrate. This provides a sub-millimeter spatial resolution, comparable to the infrared technology currently used in hospitals." Mr Huang added that the device also had a wireless heating system that could be used to determine the thermal properties of the skin. He further stated that though the technology was tested, a few additional safety tests were needed before the device could put into use.   ]]> https://biospectrumindia.com/news/97/4797/frost-sullivan-felicitate-siemens-healthcare.html https://biospectrumindia.com/news/97/4797/frost-sullivan-felicitate-siemens-healthcare.html Fri, 26 Sep 2014 15:00:05 +0530 Siemens Healthcare, India was awarded the 'Imaging Company of the Year' for 2014 at Frost and Sullivan's Sixth Annual India Healthcare Excellence Awards. The company has pioneered innovative healthcare technologies enabling diagnostic efficiency and patient safety while reducing the overall cost. It has also deployed IT solutions for service delivery processes. Speaking about this honor, Mr Richard Guest, CEO, Siemens Healthcare, India, said, "We are the trusted partners who support our customers to fight the most threatening diseases, to raise quality and productivity in healthcare and to enable access to healthcare. We would like to thank Frost and Sullivan and the esteemed jury for awarding us the Best Imaging Company of the Year, which resonates with our contribution to the healthcare industry." Mr Jayant Singh, director, South Asia and Middle East, Healthcare and Life Sciences practice at Frost and Sullivan, said, "The success of Siemens Healthcare is a combination of comprehensive range of solution offerings, single-handed focus on innovation, quality, and reliability, and focus on training and after sales backed by an excellent customer support network. It is a pleasure to recognize the efforts of a company like Siemens Healthcare, which offers innovative and quality healthcare solutions to the country." The 'Imaging Company of the Year' award acknowledges best practices adopted by companies in the Indian diagnostic imaging industry.   ]]> https://biospectrumindia.com/news/97/4563/univercell-ami-partner-to-sell-fitness-device.html https://biospectrumindia.com/news/97/4563/univercell-ami-partner-to-sell-fitness-device.html Fri, 26 Sep 2014 13:43:15 +0530 UniverCell, a mobile phone retailer, has collaborated with American Megatrends India (AMI) to sell the latest health- and- fitness-tracking device BOLT in India. Tracking devices such as BOLT are used for preventive healthcare. This device enables an individual to accurately and precisely control his or her health and lifestyle practices by intelligently interpreting the body's vital information and providing access to this data through a specially-designed, cloud-enabled smart app. Mr Satish Babu, founder, UniverCell, informed, "The work and vision behind BOLT shows through in everything from the design of the device to the smart app with its brilliant user interface. We are very excited to bring such a useful device to our customers first, even before the world sees it. At UniverCell, we constantly strive to innovate and provide easy solutions to our customers and I am sure BOLT is going to be a great addition to our customers." "We are excited to announce this agreement to launch our BOLT health monitor device into the mobile market through the UniverCell. It shares AMI's vision of how to transform healthcare and their high profile as a leader in mobile device retail will enable us to gain even greater visibility for a product which we feel has the potential to revolutionise the way ordinary people can manage their personal health and lifestyles," said chairman, AMI, Mr Subramonian Shankar.   ]]> https://biospectrumindia.com/news/97/4935/india-confident-of-green-based-product-usage-.html https://biospectrumindia.com/news/97/4935/india-confident-of-green-based-product-usage-.html Thu, 25 Sep 2014 23:03:35 +0530 Dupont India has announced the results of its "Green Living Survey 2014" in a press conference held in Hyderabad.  The results were presented by Mr Vikram Prabhu, regional director, APAC; Mr Balvindar Singh Kalsi, president, Asia and ASEAN and Mr Parijat Chakraborty, TNS. In its third edition, the focus of the study, conducted in partnership with TNS India, studied the Indian population. Face-to-face interviews were conducted among 1,270 respondents across 12 cities. The survey was to gauge 1. Awareness of green products 2. Confidence that biobased products are better for the environment 3. The purchasing trends The results of the survey revealed that India led the table in terms of confidence that the green products are better for the environment (85 percent), followed closely by China. While Canada and America led in familiarity with the products. The younger population of the country (between 18-30 years) showed the highest level of know-how. In a regional comparison, familiarity was highest in the South with 83 percent and east with 68 percent. South also led in the confidence factor. The cities surveyed included Delhi, Mumbai, Ahmedabad, Chennai, Lucknow, Bangalore, Chandigarh, Patna and Kochi. Mr Balvinder Singh Kalsi, president, South Asia and ASEAN, Dupont said, "Science is at the heart of everything we do at DuPont. We are working collaboratively to find sustainable, innovative, market-driven solutions for the Indian market. The green ;iving survey confirms that India's population is increasingly becoming environmentally conscious and demonstrates their growing preference for more sustainable products. We see great opportunity for biobased solutions in India, and our new biosciences laboratories at the DuPont knowledge center in Hyderabad are specifically focused on meeting the green aspirations of Indian customers." On display at the conference were some of the bio-based "green" clothing like jeans and a saree. ]]> https://biospectrumindia.com/news/97/3300/ge-healthcare-life-sciences-launches-new-western-blotting-system.html https://biospectrumindia.com/news/97/3300/ge-healthcare-life-sciences-launches-new-western-blotting-system.html Thu, 25 Sep 2014 15:00:27 +0530 GE Healthcare Life Sciences has introduced Amersham WB system, a fully integrated system for quantitative SDS-PAGE and Western blotting of proteins using fluorescence detection. With this new system, every stage of the Western blotting process, including electrophoresis, transfer, probing and scanning, is standardised and monitored - resulting in consistent, quantitative protein analysis. "Every life scientist has probably carried out a Western blot at some time in their career, and tens of thousands still do every week. The value of the insights provided by Western blotting has kept it relevant for more than 30 years, but its shortcomings are well-recognized. Building on GE's heritage and expertise in protein analysis, what we have developed is a system that is set to shift how scientists see and use Western blotting from now on, with a clear focus on reliability and quantification of results, regardless of user," said Mr Eric Roman, general manager of research and applied markets, GE Healthcare Life Sciences. Mr Martin Teichert, research Scientist at DKFZ (German Cancer Research Center), Germany said, "The publication landscape has changed dramatically over the past year, and the need for quantified blots and data is of significant importance for peer-reviewed journals. I think that the Amersham WB system fits perfectly into this niche, and solves this problem of having quantifiable data that can be relied upon. It has arrived at just the right time." GE Healthcare Life Sciences has developed this system, with a standardised traditional Western blotting workflow that typically achieves a variability of less than 10 per cent between users. The system's consistency and reproducibility delivers the robust quantitative data.     ]]> https://biospectrumindia.com/news/97/5305/leica-microsystems-launches-imaging-software.html https://biospectrumindia.com/news/97/5305/leica-microsystems-launches-imaging-software.html Thu, 25 Sep 2014 14:58:02 +0530 Leica Microsystems has announced the launch of its new product, Leica Application Suite X (LAS X) imaging software for lifesciences spanning all widefield, confocal and super-resolution platforms. LAS X introduces new features for microscopic image acquisition, processing and analysis while maintaining established principles of its predecessor software LAS AF, such as the workflow-based approach. LAS X guides researchers intuitively through image acquisition, data recording and evaluation in live cell imaging, providing for a maximum of reproducibility as customized system settings can be saved. Its basic version is called LAS X Core and provides numerous functions. With the Easy Operation Mode, users can design their own user interface layout. The Dye Assistant for confocal microscopes helps select the right acquisition settings by just entering the used fluorescent markers. "In developing the new imaging software platform LAS X, we have focused on the user-friendliness of the software. We have taken common workflows most users know and follow into account and translated them into software and this way continued the workflow-based approach of the predecessor LAS AF. Our software is designed to facilitate the users' research experiments are broken down step by step so that researchers can set up experiments more easily. That is the philosophy behind LAS X," said Mr Markus Schechter, product manager, Leica Microsystems. The 3D and the 2D image analysis wizards generate reproducible analysis results from multi-dimensional data sets. Analyses between separate channels can be combined to obtain object-specific data. Within the 2D Analysis wizard, tracking experiments can be performed, and image analysis protocols can be combined with ImageJ macros.  The hardware-based Adaptive Focus Control (AFC) and the software-based autofocus are integrated in LAS X. Experimental conditions such as temperature, CO2 and O2 are documented and controlled with the Environmental Control module. For long-term time-lapse and screening experiments, the software-controlled micro dispenser compensates evaporation of water immersion.   The basic version LAS X Core comes with features such as microscope control, full image viewer capability, diverse processing and quantification tools, movie export, the ability to recall imaging parameters and many more.   ]]> https://biospectrumindia.com/news/97/4399/its-splitsville-for-123-year-old-philips.html https://biospectrumindia.com/news/97/4399/its-splitsville-for-123-year-old-philips.html Wed, 24 Sep 2014 20:30:00 +0530 This dramatic split of Netherland-based Philips into two separate entities - HealthTech-Lifestyle business and Lighting business is expected to allow the company to focus more into healthcare and consumer goods. "To become the global leader in HealthTech and shape the future of the industry, we will combine our vibrant healthcare and consumer lifestyle businesses into one company," said Mr Frans van Houten, CEO, Royal Philips. The new operating structure will help the company save €100 million in 2015, and about €200 million in 2016. Philips said that both the companies will continue to use the same brand name and will be based in the Netherlands. The company, however, said that it would be difficult to comment on anything further now, especially queries related to the number of job cuts as a result of this mammoth decision. Globally, Philips employs 112,000 professionals.   In 2013, its HealthTech business recorded a sales of €15 billion and the lighting business touched €7 billion, said Philips in a statement. Independence to lighting solutions business will enable the company to expand its global leadership position and venture into adjacent market opportunities. Both companies will make appropriate investments to boost growth and drive profitability, generating more value for its customers, employees and shareholders. Shares of Philips India were trading at Rs 104.05, up by Rs 4.30 or 4.31 percent on September 24, 2014 at 19.20 hrs. It is also noteworthy that in a similar move in May 2013 by Philips' rival, Siemens AG, a German electrical equipment manufacturer, also spun-off its lighting business Osram.   Industrial analysts and experts now have their eyes fixed on the next-in-line candidate's move, General Electric (GE), which also owns similar businesses in healthcare and lighting. This September, speculations rose surrounding the acquisition of GE's appliance business by Swedish-based Electrolux for $2.5 billion. ]]> https://biospectrumindia.com/news/97/4383/shimadzu-launches-2d-liquid-chromatograph.html https://biospectrumindia.com/news/97/4383/shimadzu-launches-2d-liquid-chromatograph.html Wed, 24 Sep 2014 15:18:00 +0530 Shimadzu Scientific Instruments introduces the Nexera-e Comprehensive Two-Dimensional Liquid Chromatograph (2D-LC), a powerful separation method for the most complex sample matrices. Comprehensive 2D-LC combines two independent separation modes orthogonally in combination with a dual-loop/dual-valve alternate switching system to increase separation efficiency. The combination of different modes enables the separation of peaks that are difficult to separate using conventional LC. In addition, the system achieves the highest possible theoretical plates for LC separation. Ultra-high-speed analysis of comprehensive 2D-LC requires quick data sampling. The Nexera-e incorporates the Nexera X2 photo-diode array detector, SPD-M30A, which features high sampling rates up to 200 Hz. The Nexera-e may also be used with the LCMS-8050 triple quadrupole LC-MS/MS, which features ultra-high-speed data scanning using ultra-fast mass spectrometry (UFMS) technologies. Combining comprehensive 2D-LC with mass spectrometry detection provides an additional orthogonal dimension to this powerful chromatography separation technology. LCxLC-Assist software is the dedicated software for setting up configuration settings. This intuitive software provides easy set-up of all the 2D-LC instrument parameters. Acquired data is converted to 2D contour plotting using ChromSquare, the dedicated software for 2D-LC analysis. In addition, ChromSquare software displays an MS spectrum in real time, and can calculate a standard curve for quantitative analysis based on the contour spot.   ]]> https://biospectrumindia.com/news/97/4836/sigma-aldrich-to-collaborate-with-university-of-michigan.html https://biospectrumindia.com/news/97/4836/sigma-aldrich-to-collaborate-with-university-of-michigan.html Tue, 23 Sep 2014 17:54:00 +0530 Sigma-Aldrich has announced a collaboration with Uniersity of Michigan Medical school's Vector Core group. With this new gene editing partnership, the core is to get access to Sigma's CRISPR technology, experimental design consultation, and dedicated gene editing bioinformaticians. With this partnership, the entire Medical school will have easy access to the company's bioinformatics, design and production resources. The company already has an initiative with the university, led by assistant professor Chad Brenner, that involves constructing a large library of Sigma CRISPRs for precision study of 100 uncommon genes that cause dysfunctions associated with cancer. The study is expected to generate large amounts of unprecedented data that could play a role in simplifying personalized treatment for cancer. "We are pleased to partner with Vector Core and the University of Michigan Medical School to advance their research mission," said Mr Sean Muthian, director of Strategic Marketing and Collaborations at Sigma-Aldrich. "The Sigma-Aldrich CRISPR Core partnership helps accelerate the pace of translational research, removing the design and production hurdles with CRISPR or Zinc Finger Nucleases, hence allowing scientists to focus on their research." ]]> https://biospectrumindia.com/news/97/4303/a-new-mobile-application-van-from-ika.html https://biospectrumindia.com/news/97/4303/a-new-mobile-application-van-from-ika.html Tue, 23 Sep 2014 14:49:34 +0530 IKA, a global player in the mixing and stirring arena, has announced the launch of a new mobile application van that will showcase some of the latest releases form its product line. The van consists of the latest calorimeters, one of a kind magnetic stirrers and their patented, flagship product LA-1000.  It will tour 15 states across the country.  This van is an attempt to try and reach customers in the remote areas of the country, who do not have access to service centers or even the products that they need. They will also be tying up with educational institutions in an effort to educate the students and increase awareness. The van will also act as an on-the-go service center.Mr Peter Laser, MD, IKA India said, "We have been working on this concept for some time now. This is the result of 5 months of hard work by the entire team. The idea is to increase knowledge and educate our customers along with increasing proximity to the company," He added further, "India is like any other market. People here want updated, cost-efficient quality products." The center was inaugurated by Mr Rohde, the counsul general, Consulate General of the Federal Republic of Germany in Bangalore. ]]> https://biospectrumindia.com/news/97/4274/nanohealth-inks-pact-with-gvk-bio-.html https://biospectrumindia.com/news/97/4274/nanohealth-inks-pact-with-gvk-bio-.html Tue, 23 Sep 2014 14:25:52 +0530 NanoHealth in association with GVK Bio has launched holistic healthcare services for slum dwellers. NanoHealth is a social enterprise, founded by a group of ISB alumni specialising in chronic disease management. It has partnered with GVK BIO's proprietary HEART (Health Emphasized Analytical and Reporting Tool) platform-a cloud based healthcare analytics framework with multiple applications. NanoHealth will be the first to use mobile enabled and multilingual Disease Management Application on the HEART platform to register, enroll, record, and manage patients. The application acts as an enabler, through information processing, for the right stakeholder to decide and take action for maximum impact. Mr Shiva Subramaniam, senior vice president and head of informatics, GVK Biosciences said, "The mission of HEART is to improve general health and reduce or reverse progression of chronic diseases by building patient centric, high quality healthcare and clinical systems that are simple and accessible to all and which will enable reduction of healthcare costs for all stakeholders. We hope that the HEART platform will help manage and reduce the threat of the rapidly growing chronic diseases especially in slum dwellers where healthcare is the last priority." NanoHealth is creating a network of community health-workers known as "Saathis" and equipping them with a diagnostic device called "Doc-in-a-Box". The doctor's reach is extended by its Saathis, who are well-paid, empowered women in the community forming a strong network of caregivers. The team conducted their pilot in Anjaiah Nagar slum in Hyderabad. "NanoHealth is on a mission to prevent premature deaths caused due to chronic diseases in urban slums. We have a strong team and with the help of credible partners like GVK BIO, we are making progress every day," said Mr Manish Ranjan, CEO, NanoHealth.   ]]> https://biospectrumindia.com/news/97/4209/covidien-expands-its-sonicision-portfolio.html https://biospectrumindia.com/news/97/4209/covidien-expands-its-sonicision-portfolio.html Mon, 22 Sep 2014 12:49:28 +0530 Covidien has announced the expansion of its Sonicision Cordless Ultrasonic Dissection Device portfolio, following US Food and Drug Administration's 510(k) clearance of three additional device lengths: 13 cm, 26 cm, and 48 cm. "Covidien is a pioneer in developing energy-based medical devices and the Sonicision system's groundbreaking cordless technology continues to transform how minimally invasive surgery is performed," said Mr Chris Barry, president, advanced surgical, Covidien. He added, "These new device lengths enable surgeons to use Sonicision technology in a more diverse range of surgical procedures while avoiding the need for cords and separate generators." The Sonicision system is the only cordless ultrasonic dissection device currently available in the market. It is used in a wide variety of general, bariatric, colorectal, gynecological, and urological surgical procedures. The new device lengths allow surgeons to expand their use of the Sonicision system to an increasing number of procedures, including pediatric colectomy, splenectomy, and appendectomy.   ]]> https://biospectrumindia.com/interviews/97/5276/no-clinical-trials-equals-no-new-drugs-iscr-prez.html https://biospectrumindia.com/interviews/97/5276/no-clinical-trials-equals-no-new-drugs-iscr-prez.html Mon, 22 Sep 2014 12:44:45 +0530 Q: What is the current status of clinical research in the country now?Ms Suneela Thatte: Currently clinical research is hit by two primary reasons. Firstly, it is the clinical research review and approval timelines, which are very unpredictable. The waiting period is making India a more unattractive destination for clinical research organizations (CROs), and as well as for academicians to carry out clinical trials in the country. Secondly, the compensation guidelines have totally tilted the balance, and there is a massive misuse potential factor to it. This is driving a lot of organizations away. This is not just affecting industrial research but also academics. Usually academic researches operate on tight budgets. The current guidelines require that an average compensation payment be between Rs 35-45 lakh. This amount could be the actual proposed budget for the entire clinical trials. As a result, investigators are scared to do clinical trials, patients are doubtful about participating, and sponsors hesitate to conduct trials in India.   This applies both to Indian pharma companies and MNCs. Thus India's research innovation is going to other countries. It is excruciatingly sad to see that we can't do anything for the healthcare needs of our own country. Q: What are the negative trends that you see in the CRO business?A: The number of trials is going down. We need trials because we have unmet medical needs that are different from China or the US or other European countries. Our unmet needs are addressed by our local pharma industry. We also have affordability issues. We are moving from chemical to biological medicines, and then towards personalized medicines. However, biologicals are very expensive. But biosimilars are a solution towards making affordable medicines. Many Indian innovative pharma companies are very bullish about their biosimilars development. However, owing to the current laws, the clinical research is hampered. When clinical research happens, patients have early access to a medical breakthrough. As the number of clinical trials has gone down, today that advantage has been taken away from patients.   Q: What is ISCR doing under these challenging circumstances?A: Our approach is that, we are continuing our advocacy with regulators. We are trying to bring attention on why we need clinical research. No clinical research means no new drugs. That's the simple equation. We are working with the regulators as to how the regulations can be balanced, and simplify implementations that can be followed. We are doing this in partnership with investigators, ethics committee members and patients. Ultimately, patients need to come forward and say that clinical research has certain risks and that it may or may not benefit certain people. Q. How is the business model transitioning?A: From the industry and skill development perspective, a lot of clinical research professionals have to look at alternate career options, which is not as equally exciting as being a part of live clinical research. If clinical trials would have grown as predicted in the past, we would have had tremendous employment opportunities for medical and lifescience graduates. Sadly, that has not become a reality.   Q: How are Indian companies and MNCs responding to this?A: There is a wait-and-watch approach between MNCs and Indian pharma companies. Unfortunately, India now is not a country of choice for both of them. But the good thing is nobody has totally given up hope because India has a very good ecosystem for clinical research in terms of ethics committees or investigators. So everybody now is trying to reach out to the regulatory authorities to see how the regulations can be balanced. Q: Overall, how is the clinical trials climate in the APAC region?A: With India's exception, all the other countries in APAC are trying to facilitate clinical trials. Countries like Sri Lanka has tremendously benefited because of India's slowdown. If you look at other APAC countries, not just from the clinical research perspective but also from the innovation point of view, they are promoting innovation in every possible way like tax holidays, and offering SEZs to conduct businesses with ease.   Every country has a vision for innovation which India hasn't realized because of the policy paralysis. Hopefully, now we have seen some changes with the new government in the center. Q: Which are the APAC countries that are leading in clinical trials?A: Malaysia, Singapore, China, Taiwan, and Korea are doing extremely well in supporting innovation. We are way behind Taiwan and Korea in terms of clinical trials. Q: Are you seeing new CROs cropping up in India despite the dilemma?A: Many clinical research companies are not public. So we don't have new entrants at this stage. But many CROs are re-skilling and are looking at other support businesses like data management and data processing. These are the areas where they are diversifying, so that their employees have alternate options. Q: What is the status of the recommendations laid out by Prof. Ranjit Roy Chaudhury expert committee?A: Quite a few of them have now been acknowledged by the way of office orders, whereby the intent to implement them has been published by the government. Now what is important to see is the implementation roadmap.   Q: What is the proposed solution for overcoming these challenges?A: The only proposed solution in my view is the stakeholder consultation. The regulators must hear from all the stakeholders and balance the regulations. Again, policy stringency is necessary, and regulations have to be robust, but they need to be predictable and balanced. This will only happen through stakeholders' consultation. Clinical research should not be looked at as a separate specialty. We should look at it as a part of the healthcare agenda of our country. That is the approach we have to take and then solve issues that are unique to our own country in terms of lack of healthcare access. ]]> https://biospectrumindia.com/news/97/4049/thermo-fisher-next-gen-sequencing-system-is-for-clinical-use.html https://biospectrumindia.com/news/97/4049/thermo-fisher-next-gen-sequencing-system-is-for-clinical-use.html Sat, 20 Sep 2014 11:45:00 +0530 Thermo Fisher Scientific's Ion PGM Dx next generation sequencing system has been listed with the US Food and Drug Administration (FDA) for clinical use as a class II medical device. "Next generation sequencing is rapidly becoming an indispensable tool for clinical laboratories around the world, allowing clinical professionals to simultaneously screen hundreds of genes from patient samples to provide key genetic information and enable patient enrollment within clinical trials," said Mr Mark Stevenson, president, Life Science Solutions at Thermo Fisher Scientific. "The Ion Torrent platform and accompanying reagents provide a number of unique advantages to clinical customers, enabling accurate and reliable genetic variant analysis from more samples due to low DNA input requirements (10ng) and faster turnaround times that reduce the time of sample to result." The new Ion PGM Dx System is intended for targeted sequencing of human genomic DNA using peripheral whole blood samples, the Ion PGM Dx System supports development and implementation of user defined NGS diagnostic assays in a clinical laboratory and enables 21 CFR Part 11 compliance. The System was validated using a large control panel that contains an extensive number of germline variants that are representative of a range of human conditions, demonstrating the high level of performance achieved by the platform, and required in a clinical environment. When used for diagnostic assay development, customers may define, validate, lock and publish protocols in a role-based workflow for implementation into routine use, from library construction to variant calling. The Ion PGM Dx System will include the instrument specific library kit, template kit, sequencing kit, and 318 chip, all manufactured under GMP. Based on 200bp chemistry, the library kit will also include barcodes to enable cost effective and flexible processing of up to 16 samples within a single run. The System provides integrated data analysis software for sample and reagent tracking capability, QC metrics, audit trails, and a suite of software controls to aid clinical laboratories in maintaining high performance standards with the implementation of each new assay. "The development of the Ion PGM Dx System is representative of our continued commitment to enable our clinical customers to develop new molecular diagnostic assays within the rapidly changing regulatory environment," said Mr Stevenson. "This new addition builds upon our growing line of Thermo Fisher Scientific's diagnostic platforms for genetic analysis including the Applied Biosystems 3500 Dx Series Genetic Analyzers and Applied Biosystems QuantStudio Dx Real-Time PCR instrument. As we look to the future, we plan to continue investing in our Ion PGM Dx System by enhancing user defined NGS diagnostic assay capabilities and by providing an expanded menu of clinically focused IVD diagnostic NGS assays for our customers, with an emphasis on oncology."   ]]> https://biospectrumindia.com/news/97/4534/hitachi-iiit-h-develop-technology-to-analyze-electronic-medical-records.html https://biospectrumindia.com/news/97/4534/hitachi-iiit-h-develop-technology-to-analyze-electronic-medical-records.html Fri, 19 Sep 2014 17:13:08 +0530 Hitachi has announced that they have developed a new technology to extract precisely designated information from electronic medical records in collaboration with International Institute of Information Technology, Hyderabad (IIIT-H). This new technology makes it possible to analyze electronic medical records including various mixed-forms such as free-form texts written by doctors or laboratory data written in given formats. Hitachi India, Hitachi, and IIIT-H won the first prize with an extraction precision of 86.8 percent in CLEF(1) e-Health 2014 Task2(2), a technical competition on medical information extraction, which was held by a European Research Forum CLEF for developing this technology. This will be presented at the CLEF Conference 2014 in UK. To predict the incidence rates of a disease, it is necessary to analyze medical record texts such as doctors' remarks as well as the input information in the given format such as blood test results. Mr Ichiro Iino, managing director, Hitachi India said, "We are proud that we won the first prize in this competition. Hitachi India, Hitachi and IIIT-H have collectively worked as a strong team to come up with this technological innovation. We firmly believe that it would help build a sustainable society with reduced health risk. We are honoured to achieve this mark, which will act as a catalyst." "We are delighted to achieve this breakthrough in association with Hitachi in the field of technology and healthcare. This technology will help a great deal in prevention or reduction of disease risks. It was a learning experience to work with Hitachi, which shares the same passion for producing futuristic technology as we do. We hope to create such fruitful alliances in future too," said Prof. PJ Narayanan, director, IIIT-H.   Hitachi India and Hitachi will continue to improve this extraction technology, and develop new technologies leading to the creation of advanced medical services.   ]]> https://biospectrumindia.com/news/97/5452/us-fda-clears-siemens-somatom-scope-ct-system.html https://biospectrumindia.com/news/97/5452/us-fda-clears-siemens-somatom-scope-ct-system.html Fri, 19 Sep 2014 16:32:56 +0530 Siemens Healthcare has announced that the United States Food and Drug Administration (US FDA) has cleared the SOMATOM Scope, a new 16-slice computed tomography (CT) scanner. It is a new addition to the SOMATOM family of CT scanners. The SOMATOM Scope is available in two configurations-Scope and Scope Power. It enables healthcare providers to comply with the NEMA XR-29 Smart Dose Standard, ensuring a safer imaging experience for patients. "By adding the Scope to our portfolio of SOMATOM CT scanners, we help bring CT imaging closer to the point of care, enabling our customers to focus on what matters the most: improving care through more informed, timely clinical decision-making," said Mr Murat Gungor, vice president, computed tomography and radiation Oncology business management at Siemens Healthcare. He added, "The SOMATOM Scope helps to ensure that a greater segment of the patient population has access to innovative technologies while enabling facilities to help control costs as well as save time and effort throughout their daily routine." The SOMATOM Scope is designed for use in routine diagnostic imaging as well as oncological examinations, interventional radiology, and vascular imaging, and the more robust SOMATOM Scope Power with its stronger X-ray tube, higher performance generator, and faster rotation speed is ideal for higher volume clinical settings. The new device utilizes Siemens' breakthrough IRIS (Iterative Reconstruction in Image Space) technology, which accelerates image reconstruction while reducing noise and artifacts. And the system's Adaptive Signal Boost technology amplifies low signals when high attenuation is present. It also includes Siemens FAST (Fully Assisting Scanner Technology) and CARE (Combined Applications to Reduce Exposure) applications to help reduce radiation exposure and standardize the CT imaging process - freeing up more time for technologists to interact with patients.       ]]> https://biospectrumindia.com/news/97/4476/indias-cochlear-implant-ready-for-clinical-trials.html https://biospectrumindia.com/news/97/4476/indias-cochlear-implant-ready-for-clinical-trials.html Fri, 19 Sep 2014 15:30:00 +0530 Researchers at the DRDO labs-Naval Science and Technological Laboratory (NSTL), Naval Materials Research Laboratory (NMRL), Anurag, Research Center Imarat (RCI) and Defence Institute of Physiology and Allied Sciences (DIPAS), Armed Forces Medical College (AFMC) and Andhra University have developed the world's cheapest cochlear implants. Reportedly, an application seeking permission for clinical trials has been filed with the Drugs Controller General of India (DCGI) on behalf of the Society for Biomedical Technology (SBMT). One million people in the country suffered from profound hearing loss, while every year 10,000 infants are born with the same problem. The device would cost around Rs 1-1.5 lakhs. Researchers will conduct multi-centric clinical trials across the country for about six months to one year after receiving the nod from DCGI. After the successful completion of clinical trials, the technology would be transferred to an Indore-based company for serial production. It is expected to be ready for commercial production in a year.   ]]> https://biospectrumindia.com/news/97/3939/a-new-digital-radiography-system-by-cura.html https://biospectrumindia.com/news/97/3939/a-new-digital-radiography-system-by-cura.html Fri, 19 Sep 2014 15:12:00 +0530 Chennai-based CURA Healthcare has launched a DReam Digital Radiography system, a revolutionary product. This is the company's patent design system. DReam offers a unique single detector design that can be used in any position, all without moving the detectro. It comes with flat panel technology, providing high image quality. Radiation emitted by DReam is very low, ensuring patient safety especially for pediatric patients as it emits 25-50 percent lesser radiation as compared to other systems. It is a lifesaving system for emergency, trauma, and accident cases and has a very high patient throughput of upto 300 patients per day Mr Balasubramaniam, CEO, CURA Healthcare said, "The entire concept of going digital makes the process quick and very efficient. With such technological advancements, services provided are better with accurate results. The new Digital Radiography technology is superior, cost effective, and much healthier than the existing technologies available for both patients and radiologists. CURA aims to bring in such ground-breaking technology accessible to everyone and change the medical healthcare scenario for the better." CURA is also taking DReam, and other such medical equipment and instrument solutions to smaller towns to provide the right healthcare. It is bridging the gap in medical treatment by bringing in products that are low-cost but effective in rural areas.   ]]> https://biospectrumindia.com/news/97/3832/silver-leaf-oak-acquires-10-stake-in-syngene-.html https://biospectrumindia.com/news/97/3832/silver-leaf-oak-acquires-10-stake-in-syngene-.html Thu, 18 Sep 2014 21:21:59 +0530 Silver Leaf Oak (Mauritius) Limited, an investment vehicle advised by India Value Fund Advisors (IVFA) has agreed to acquire a minority 10% stake in Syngene International, Biocon's Research Services subsidiary. Silver Leaf will acquire the stake from Biocon Research Limited (BRL), a wholly owned subsidiary of Biocon Limited at a valuation of Rs 3800 crore. Biocon's shares was at Rs 499.95, up by Rs 13.15 or 2.7% at 1900hrs, on September 18, 2014. The transaction is subject to standard condition precedents including regulatory approvals. Post the completion of this transaction, Biocon and BRL will jointly hold 85.54% stake in Syngene.   The Biocon Group was advised by Allegro Advisors. The lawyers for Biocon Group and Silver Leaf Oak were Wadia Ghandy and DSK Legal, respectively.   ]]> https://biospectrumindia.com/news/97/8203/oxford-instruments-launches-a-new-service-center.html https://biospectrumindia.com/news/97/8203/oxford-instruments-launches-a-new-service-center.html Thu, 18 Sep 2014 16:45:00 +0530 The company has announced the launch of a new local analytical instrumentation support service, which will be based out of Mumbai. Speaking during the inaguration of the services, Mr David Scott, group director, Emerging Markets, said "The OiService mission is to allow our customers to concentrate on their own business objectives safe in the knowledge that we are always there to provide full support. The wide range of offerings provided by OiService will enable our customers to increase uptime and reduce cost of ownership." The facility will be staffed with qualified technical engineers. It will also have a service workshop; a genuine spare parts warehouse; Instrument Re-calibration and certification services and a tailored service. Mr Anurag Tandon, managing director, Oxford Instruments India, said "Our goal is to provide our customers with faultless service and swift expert maintenance on our products to ensure they perform to their highest capabilities." ]]> https://biospectrumindia.com/news/97/3883/a-software-to-detect-human-emotions.html https://biospectrumindia.com/news/97/3883/a-software-to-detect-human-emotions.html Thu, 18 Sep 2014 15:03:57 +0530 A team of scientists, Mr Dev Drume Agrawal, Mr Shiv Ram Dubey and Mr Anand Singh Jalal of the GLA University, Mathura have developed a computerised emotion detector. This Face recognition software detects emotions from a simple mug shot of the face. Face recognition software measures various parameters in a mug shot, such as the distance between the person's eyes, the height from lip to top of their nose and various other metrics and then compares it with photos of people in the database that have been tagged with a given name. The researchers said that the recognition of emotions by future artificial intelligences, in the form of computers or robots, will provide a missing link between the human and machine environments without which appropriate interactions between the two domains may never be entirely successful. The team has taken a three-phase approach to a software emotion detector. The first involves developing an algorithm that can precisely identify and define the features of the human face. The second phase analyses the particular positions and shapes of the face. The third phase then associates those features with a person's emotional state to decide whether they are happy, sad, angry, surprised, fearful or disgusted. Preliminary tests gave a 94 percent success rate, the team reports. "Our experimental results suggest that the introduced method is able to support more accurate classification of emotion classification from images of faces," said the team. They added that the additional refinements to the classification algorithms will improve their emotion detector still further. The research is published in the International Journal of Computational Vision and Robotics.   ]]> https://biospectrumindia.com/features/97/7518/medi-analytika-a-steady-growth-based-on-innovation.html https://biospectrumindia.com/features/97/7518/medi-analytika-a-steady-growth-based-on-innovation.html Thu, 18 Sep 2014 11:38:00 +0530 Medi Analytika, established in 1994, is a leading instrumentation company, supplying state of-the-art instrumentation from world's leading instrumentation companies from USA, Europe, Israel, Brazil, and Japan. Employing over 45 professionals, the company recorded a turnover of Rs 59.75 crore for FY 2013-14, which is up by Rs 4.55 crore compared to the last fiscal is Rs 55.20 crore.The company's major customers include all IITs, IISE`and major pharma companies including Mylan, Advinus, Aurigene, Dr Reddy, Lupin, Sun Pharma, Lupin, Glenmark,Intas, NATCO Pharma, Wockhardt, Ranbaxy, Torrent Pharma, Zydus Cadila, Panacea Biotec, Troikaa Pharmaceuticals, and Sai Advantium.In the last fiscal, the company supplied 3D Laser scanning microscope from Femtonics, Hungary; Brain functional Imager from Optical Imaging, Israel; Cuvette microscope from Resolution Optics, Canada; and Hypoxia chambers from Oxford Optronix, UK.The company announced several key wins. Medi Analytika signed major deals with Advinus Therapeutics, Panacea Biotec, Sun Pharmaceutical, Jai Research Foundation, United Biotech, IISER, IIT Kanpur, IIT Kharagpur, National Brain Research Center, Lupin Pharma R&D Center, inSTEM, CCMB, Intas Pharmaceuticals, Indian Institute of Science, Zydus BSV, and NCBS. In the next fiscal year, the company looks forward to expand its business further and optimistically sees the markets to be very promising. ]]> https://biospectrumindia.com/news/97/7587/sap-to-hire-autistic-it-professionals.html https://biospectrumindia.com/news/97/7587/sap-to-hire-autistic-it-professionals.html Wed, 17 Sep 2014 14:42:50 +0530 This worldwide program started as a pilot project in India. Six autistic software testers, whom SAP Labs India hired through Specialisterne, a Danish company that helps autistic people around the world find technology-oriented jobs. This resulted in an increase in SAP Business Suite's productivity and team cohesion. One percent of SAP's global workforce will be autistic by 2020. Autistic employees can offer competitive advantages, according to SAP, while helping the individuals secure meaningful employment. Research studies show that autistic patients show exceptional observation and concentration coupled with a high intellectual test score. Most of the employees in Specialisterne have a diagnosis on the autism spectrum, typically serving as consultants in fields such as software testing, programming and data entry. "People with autism bring special skills," said Ms Anka Wittenberg, SAP chief diversity and inclusion officer. "Autistic people have a particularly strong sense of visual perception, which among other things is very useful when testing software." Another pilot in Ireland is wrapping up the screening phase for five positions. SAP will expand the program globally this year, starting in the US, Canada, and Germany. ]]> https://biospectrumindia.com/news/97/4612/in-clinical-trials-fiasco-patients-worst-affected-.html https://biospectrumindia.com/news/97/4612/in-clinical-trials-fiasco-patients-worst-affected-.html Wed, 17 Sep 2014 14:34:29 +0530 All these factors and the uncertainty and unpredictability of regulatory direction has led to a hesitancy and lack of confidence in biopharma companies, academic and teaching institutions and not-for-profit organizations doing clinical research in India. For many thousands of patients, participation in a clinical trial can provide early access to new therapies including for debilitating and life-threatening conditions. For patients who have run out of other options, clinical trials are often the last option. There is a need to create a sound clinical research ecosystem that encourages local research and innovation. There are several biopharma companies, not-for-profit organizations, and teaching and medical institutions in the country doing a lot of valuable research in diseases that affect our populations. We need to encourage such innovation and not deter the scientific and medical community from continuing in the quest to find safer and more effective treatment for our disease burden. Ms Suneela Thatte feels that the declining number of clinical trials in India does not augur well for a country with an increasing healthcare burden. "Considering that India has 16 percent of the world's population and 20 percent of the global disease burden and does less than 2 percent of global research, the country's responsibility towards the health of its citizens is critical in creating an enabling environment for clinical research and drug innovation," said Ms Thatte. Dr Jitendra Verma, managing director, Lifecare Innovations said, "Clinical trials and field trials of biotech and bio-pharma products consume most of the patent life, depriving return on investments in R&D and thus discouraging R&D for developing new drugs or products." Dr Verma believes that there should be funding of trials for crucial diseases, done especially by small companies. "Clinical trials by innovators for translational research must be encouraged by timely approvals and funding support by the government," he told BioSpectrum. ]]> https://biospectrumindia.com/news/97/5087/cdsco-hands-new-commandments-for-pharma-cos-and-cros-.html https://biospectrumindia.com/news/97/5087/cdsco-hands-new-commandments-for-pharma-cos-and-cros-.html Wed, 17 Sep 2014 12:51:00 +0530 According to a new order issued by the Central Drugs Standard Control Organization, pharma companies and clinical research organizations (CROs) now need to explain and justify their research while conducting clinical trials in India.Companies now are mandatorily expected to lay out all the parameters during the application filing process. The parameters include assessment of risks versus benefits to patients, innovation details and existing therapeutic treatments, and information on unmet medical needs. ]]> https://biospectrumindia.com/news/97/6029/wellness-genomics-project-exploring-longevity.html https://biospectrumindia.com/news/97/6029/wellness-genomics-project-exploring-longevity.html Tue, 16 Sep 2014 14:41:05 +0530 Why do some people live longer? Do they have any special types of genes? Do their genomes have anything in common? Do they have special genes which are expressed at varied levels? Scientists at the Institute of Genomics and Integrative Biology (IGIB) are trying to find answers to these questions. The project, funded by CSIR, titled 'Wellness Genomic Project' is led by Prof. Sameer K Brahmachari, former DG, CSIR along with his colleagues Dr Sridhar Sivasubbu and Dr Vinod Scaria, who are also scientists at IGIB. Speaking about the project, Prof. Brahmachari said, "We wanted to be a part of Xprize Archon genomics so that we have access to all the data. Unfortunately, Xprize got closed. But we decided to sequence the Indian genome, and 91 in India is as good as 100 in Japan. We are trying to find out what signals longevity by studying their genome.'' (ArchonX prize was a competition that offered $10 million to the first team that could rapidly and accurately sequence 100 whole human genomes of centenarians at the cost of $10,000 or less per genome.) They have collected 88 samples (of people aged 91 or above) from across India, out of which 16 have been sequenced so far. They have formulated few theories. He elaborated further, "The idea is to find something common in these genes. Some special types of genes or other genes whose activity is slightly higher than the others. We are looking at C elegans genes which have been shown to be related to longevity. Are these genes different here? If we can find a marker or some particular metabolism process that allows longevity, it could give us some new information. We have formulated these theories, however, it might also be possible that we find something new." Sequencing is not an easy task, and sequencing the genome of centenarians is even more difficult, as it is very hard to collect blood samples from them. So working with small samples with present day technology, and to analyse large genomic data, are some of the challenges in this project.   We hope that after sequencing 30 genomes, we will have statistically significant data, sums up Prof. Brahmachari. If the project is successful, it would pave the way for long and healthy living.   ]]> https://biospectrumindia.com/news/97/5051/googles-lift-labs-launches-a-new-spoon.html https://biospectrumindia.com/news/97/5051/googles-lift-labs-launches-a-new-spoon.html Tue, 16 Sep 2014 12:41:00 +0530 Google's new acquisition, Lift Labs has manufactured a self-stabilizing spoon for neurological patients. The tech giant said in a statement that it plans to explore how Lift lab's technology can be utilized to help people with neurological disorders. Lift Labs would be integrated into Google Life Sciences, which is a part of Google X, the company's long-term projects division. "I hope that the Liftware spoon would be the beginning of a long road that could potentially lead to other technologies, such as adding in diagnostic tools that could monitor tremors over time," said Mr Andrew Conrad, head, Google Life Sciences. Lift lab's spoon is embedded with sensors in the handle, which senses the movement of a hand tremor and triggers a tiny motor to move the head of the spoon in the opposite direction, keeping it relatively stable while the user eats. Though, Google has recently made a number of investments in lifesciences companies and also launched Calico, a new venture to work on treatments for old-age related diseases, the company said that intense regulation of healthcare products will keep it from diving too far into the healthcare sector.       ]]> https://biospectrumindia.com/news/97/4750/cognizant-acquires-trizetto.html https://biospectrumindia.com/news/97/4750/cognizant-acquires-trizetto.html Tue, 16 Sep 2014 12:11:29 +0530 In a bid to expand its market position in the healthcare sector, Cognizant purchased Colorado-based TriZetto, a healthcare IT services provider for $2.7 billion. Speaking about the acquisition, Cognizant's CEO Mr Francisco D'Souza said, "Healthcare is undergoing structural shifts due to reform, cost pressure, and shifting responsibilities between payers and providers. This creates a significant growth opportunity, which TriZetto will help us capture," in a statement. Healthcare accounts for 26 percent of Cognizant's revenue, which was $8.84 billion last year. TriZetto will further boost the company's revenue in the healthcare sector. "We are excited that the integrated portfolio of capabilities across technology and operations will uniquely position us to help clients drive higher levels of operational efficiency, while re-imagining care for the future. We look forward to welcoming the TriZetto team into the Cognizant family and creating a truly differentiated and sustainable foundation for healthcare," added Mr D'Souza. This is said to be the company's biggest deal ever. The combined worth of the two companies is estimated to generate more than $3 billion in healthcare revenue.   ]]> https://biospectrumindia.com/news/97/4596/google-earth-to-predict-malaria-.html https://biospectrumindia.com/news/97/4596/google-earth-to-predict-malaria-.html Tue, 16 Sep 2014 12:06:38 +0530 Researchers at the University of California, San Francisco (UCSF) are developing an online platform that can be used to predict malaria transmission with the help of Google earth. Their goal is to enable poor countries to plan more targeted and effective campaigns against the mosquito-borne disease which kills more than 600,000 people in a year. With the malaria prediction platform, local health workers will be able to upload their own data like where and when malaria cases have been occurring. This can be combined with real-time satellite data on weather and other environmental conditions within the earth engine to predict where new cases are most likely to occur. This will help in taking the necessary steps to prevent the disease in a predicted area. Google earth outreach is donating to the UCSF $100,000 to develop this platform. The new tool will be piloted in Swaziland, a South African country. Researchers also plan to make the tool available to health workers in other countries, those working with the Global Health Group's Malaria Elimination Initiative. This tool can also be adapted to predict other infectious diseases.   ]]> https://biospectrumindia.com/news/97/4593/bmg-launches-a-new-atmoshperic-control-unit.html https://biospectrumindia.com/news/97/4593/bmg-launches-a-new-atmoshperic-control-unit.html Mon, 15 Sep 2014 15:33:56 +0530 BMG Labtech has announced the launch of it's new product, an Atmospheric Control Unit (ACU) to regulate and control the amount of oxygen (O2) and carbon dioxide (CO2) within a microplate reader chamber. The ACU provides optimal environment needed for any live cell assay. The microprocessor-controlled unit can regulate CO2 (0.1 - 20 percent) and O2 (0.1 - 20 percent) independently, and reproduce the specific physiological conditions needed for cell-based assays. In combination with CLARIOstar's extended temperature control and three different shaking options (orbital, double orbital, and linear), the ACU is able to provide the right physiological environment for any cell type. Accurate gas regulation is guaranteed by the incorporated altitude correction feature. The device has integrated gas pressure regulators which allows easy setup and eliminates the need for any more pressure regulators. Furthermore, the integrated pressure sensors combined with an acoustic alarm allows for easy control of both gas supplies. A superior valve gas control ensures minimal gas consumption. The user interface is intuitive, and comes with a backlit LCD touchscreen and the possibility of defining up to 10 user-presets along with the display of gas concentration curves over time. The company's products are distributed by Biotron Healthcare in India.   ]]> https://biospectrumindia.com/news/97/5917/staring-at-a-bleak-future.html https://biospectrumindia.com/news/97/5917/staring-at-a-bleak-future.html Mon, 15 Sep 2014 15:11:00 +0530 Choked by hyper activism on one side and uncertain regulations on the other, the clinical research industry in India is no longer an attraction. Despite its strengths of offering low cost English speaking workers, sites, and volunteers, it has lost its sheen as a potential ground for conducting clinical trials. While reasons are multifold, the immediate one is the significant decline in approvals to new trials. The litigations by activists too have stalled activities to great extent. The allegations of irregularities made the Supreme Court of India issue a ban on clinical trials but subject to changed norms. As per sources, out of close to 162 trials that were cleared by the health ministry in July-August, 2014, there were only 4 of them that were actually conducted. There has been a drop rate of 60 percent in the clinical trials conducted by Indian CROs. The average loss of business revenues stood anywhere between 30 to 40 percent. "Over a period of time, there has been a decrease in the number of trials. From 2010 onwards, there has been a five-fold downturn in trials owing to the negative environment prevailing in the country", said Dr Shoibal Mukherjee, an experienced clinical research expert. In 2012, about 272 trials were approved, followed by 107 in 2013 and the year, 2014 has witnessed a slight increase in number but the success rate cannot be determined by approvals but the actual trials that take place. The slowdown in clearance is also evident in the case of new drug approvals. While 35 new drugs were approved by the regulator in 2013, only seven new medicines have received a go-ahead so far this year. There used to be a time when India was looked at as the best destination to do trials but now, in order to compete with other Asian nations, the country has to improve its quality standards and clear the regulatory uncertainty. In case India streamlines its regulatory scenario, it can still be counted among one of the favourable destinations owing to trial costs, which can be 70 percent lesser than the west. Also, the R&D costs in India are substantially low than those in the developed countries making it possible to conduct both new drug discovery research and novel drug delivery system programs at competitive rates. Besides, here in India, clinical studies for the evaluation of various alternate systems of medicine can also be conducted. There are numerous government-funded medical and pharmaceutical institutions with state-of-the-art facilities, which can serve as ideal centers for multi-centered clinical trials. "Clinical research in India should be reflective of the country's ever increasing healthcare needs," said Ms Suneela Thatte, president, Indian Society for Clinical Research (ISCR) at a panel discussion held in Delhi to discuss the clinical research environment in the country. "The growth in the industry, which peaked from 2005 to 2010, has seen a massive decline in the last few years, due to widespread misconceptions and the uncertain and unpredictable regulatory environment. We need to ensure that enough research is being done in India to address our triple burden of diseases which include communicable diseases, non-communicable diseases related to lifestyle, and infectious diseases." In India, the CRO sector is highly fragmented and varies from hundreds of small, specialised service providers to several large full service businesses with global operations. Among the strategies employed by CROs, one is either to become a complete service provider or cater to niche services. There are also only a few companies that have their own investigative sites but more and more companies own their research bases. The acquisition of smaller firms by large full-service companies has of late been a reason behind consolidation.   The industry body representing leading pharma companies, the Indian Pharmaceutical Alliance (IPA) in a letter to the health minister, Dr Harsh Vardhan, stressed on the need for an out-of-court settlement with health activists, fighting for the rights of clinical trial participants. "The government's job should be to create enough safeguards and provisions to ensure that the rights and safety of subjects in a clinical trial are not compromised but this does not mean stopping business or development work," the IPA said, adding "what is happening now is hindering access to affordable medicines and this is not in favour of patients either.Among the top multinational pharmaceutical companies Pfizer, Glaxo Smith Kline, Aventis, Novartis, Novo Nordisk, Astra Zeneca, and Eli Lilly have been conducting clinical trials in India, apart from the Indian companies like Dr Reddys, Nicholas Piramal, Cipla, and Lupin. Full time clinical research companies such as Quintiles, Max Neeman International, Syngene, and Fortis Clinical Research are among few others. However, gradually there have been trends of shifting trial locations outside India due to prevailing uncertainty. Dr Renu Razdan, vice chairman, Association of Contract Research Organization (ACRO) believes that there can be no alternative for clinical research and there have to be corrective measures before it is too late. "Shifting of trial sites out of India is going to harm patients, science, and human resources equally. In medical science, the sharing of knowledge on cutting edge technologies and new research data is important. When we do not do that, we lag behind in innovation. As a result of the current situation, countries such as Korea, Malaysia, Bangladesh etc are on the hot list of the companies who are looking for alternatives to do trials. Certainly, a harmonious regulatory environment is important for them to have the confidence to go ahead with trials," says Dr Razdan, who is also the chief operating officer at Max Neeman International. To gain an upper hand in the global market, this sector requires regulatory clarity and fast approvals on case to case basis. This is the only way the investors of pharma companies, who have been disappointed due to existing scenario, can gain confidence in India again. The country that was projected to conduct 5 percent of the global clinical trials last year, currently is not even conducting 2 percent of it. The situation can be salvaged only by a strong voice and awareness campaign about its importance sans commercial interests by the industry among common masses. ]]> https://biospectrumindia.com/news/97/3795/biotek-to-be-a-part-of-aha-heart-walk-2014.html https://biospectrumindia.com/news/97/3795/biotek-to-be-a-part-of-aha-heart-walk-2014.html Mon, 15 Sep 2014 13:31:47 +0530 BioTek has announced that a team of employees will be participating in this year's Heart walk, to be held on Sept 27, at Oakledge Park in Burlington. This is in support of the American Heart Association (AHA). According to a company press release, over $17,000 was raised by employees through fundraising and donations, and they walked 3 miles with many other participants in last year's Vermont Heart Walk. This year's fund raising activity includes a social media blitz and BioTek will donate $1 for every Facebook like the company gets on its homepage, said the release. ]]> https://biospectrumindia.com/news/97/4101/scientists-develop-an-app-to-detect-parkinsons-.html https://biospectrumindia.com/news/97/4101/scientists-develop-an-app-to-detect-parkinsons-.html Sun, 14 Sep 2014 14:39:00 +0530 Scientists have developed a new smartphone app which can detect early signs of Parkinson's disease much before people experience tremors. The app picks up subtle changes in a person's voice, walk, and manual dexterity to diagnose the condition. "The condition is hard to diagnose, with specialists having to take a detailed history of people's symptoms and analysing them for physical signs of the disease. Using smartphone data may help to make this process much easier," said Dr Max Little, a mathematician from Aston University who is leading the project. Reportedly, the app is being tested in a group of 2,500 people with diagnosed Parkinson's symptoms, or genes known to be linked to the disease, and healthy individuals. An earlier analysis of a voice recording revealed that the app can detect Parkinson's with 99 percent accuracy from effects such as increased breathiness, drifting pitch and altered vowel sounds.   ]]> https://biospectrumindia.com/news/97/5602/life-technologies-launches-gene-editing-products.html https://biospectrumindia.com/news/97/5602/life-technologies-launches-gene-editing-products.html Sun, 14 Sep 2014 14:02:00 +0530 To expand its portfolio in molecular biology, Life technologies has launched new GeneArt CRISPR products. These products leverage the type II CRISPR (clustered regulatory interspaced short palindromic repeats)/Cas9 system for genome editing. These use a RNA guided DNA endonuclease system, which works with the endogenous repair systems to alter the DNA of a cell. The CRISPR product portfolio offers two options for complete flexibility and ease of use. The first, GeneArt CRISPR Nuclease mRNA is ready to transfect wild type Cas9 in the mRNA format. It is best for multiplexed screening of gRNA sequences, applications that require delivery by microinjection, and easier dosage optimization of Cas9 protein to gRNA in the cell. It is a better option for difficult to transfect cells such as induced pluripotent stem cells, or iPSCs. The second is The GeneArt CRISPR Nuclease Vector Kits offer reporter and enrichment tags for tracking gene editing experiments. They are great for cloning and re-use of confirmed gRNA sequences. The GeneArt CRISPR Nuclease Vector with CD4 Enrichment is a vector system for the expression of the functional components of the CRISPR/Cas9 technology with a CD4 reporter. GeneArt CRISPRs can be used with other gene editing tools, such as the GeneArt Genomic Detection Cleavage Kit. "CRISPRs' provide a way to quickly and easily target those genomic sites that a researcher wishes to modify in order to engineer cells," said Mr Helge Bastian, vice president for synthetic biology, Life Sciences Solutions, Thermo Fisher scientific. He added, "Our new CRISPR kit format, along with our transfection reagents, offers a simplified workflow that enables the less-experienced user to easily carry out gene editing."   "These latest additions demonstrate our commitment to build a portfolio from which researchers can select tools that fit their application, and we also offer in-house expertise, ready to advise on that selection," added Mr Bastian.   ]]> https://biospectrumindia.com/news/97/4105/the-social-network-of-weight-loss.html https://biospectrumindia.com/news/97/4105/the-social-network-of-weight-loss.html Sun, 14 Sep 2014 13:59:00 +0530 Social media programs designed to help people lose weight can be a useful tools in the global fight against obesity, according to a recent study. "One advantage of using social media over others is that it offers the potential to be much more cost effective and practical for day-to-day use when compared to traditional approaches," said Mr Hutan Ashrafian, department of surgery and cancer, Imperial College, in a statement. He added, "The feeling of being a part of a community allows patients to draw on the support of their peers as well as clinicians. They can get advice from their doctor without the inconvenience or cost of having to travel, and clinicians can provide advice to many patients simultaneously. There are also possible downsides, such as potential privacy issues and a need for the patient to be internet savvy, so it may not be right for everyone." Researchers reviewed the data from 12 studies across the United States, Europe, East Asia, and Australia that evaluated social networking services for weight loss. "The studies we looked at were the first to investigate social media approaches to obesity. There needs to be more research into this area to see what approaches work best for which patients, in light of the dramatic global adoption of social media tools and content. The use of social media to treat obesity encourages patients to be more proactive and empowers them to contribute towards their own treatment. It's not the only solution to the obesity epidemic, but it should be introduced as an element of every country's obesity strategy, " added Mr Ashrafian.     ]]> https://biospectrumindia.com/news/97/5787/electronic-skin-can-detect-breast-cancer.html https://biospectrumindia.com/news/97/5787/electronic-skin-can-detect-breast-cancer.html Sun, 14 Sep 2014 13:35:00 +0530 Scientists have developed an electronic skin which can detect small lumps in the breast, less than 21 mm. These lumps usually go undetected in the currently available methods of screening. Early detection of breast cancer improves survival rate by 94 percent, experts said. The research was published in the Journal ACS Applied Materials & Interfaces. Researchers developed this electronic skin out of nanoparticles and polymers that can detect and feel small objects. The device has been tested on a breast model made of silicone. It can also be used to screen patients for early signs of melanoma and other cancers.     ]]> https://biospectrumindia.com/features/97/5294/towa-remains-steady-for-another-consecutive-year.html https://biospectrumindia.com/features/97/5294/towa-remains-steady-for-another-consecutive-year.html Sat, 13 Sep 2014 10:03:00 +0530 The revenue recorded by Towa Optics in FY 2013-14 stood at Rs 90.85 crore as compared to Rs 83.54 crore generated in FY 2012-13. The after sales support provided through its network of 10 branches spread all over India, is counted as the company's major strength. Towa Optics as the authorized distributor, represents many leading international companies such as Nikon, Japan; Andor, UK; Linkam, UK, and Genikon, Italy, for their biological microscopes, imaging systems, cooled/uncooled scientific cameras, semi-conductor inspection equipment, controlled equipment, histopathology/cytology products etc. The company supplies Nikon's new  BioStation incubator imaging system that takes live cell imaging to new levels of sophistication by providing consistent environmental control of temperature, humidity, and gas concentration when managing, observing and recording cell growth, morphology, and protein expression in culture.Towa has been an exclusive distributor of Nikon Corporation, Japan, for their biological microscopes in India. Initially, it was not easy to sell Nikon Microscopes, as it was known only for cameras. In a short time due to aggressive promotion and defined sales strategy Nikon Microscopes became popular and currently occupy more than 28 per cent market share. Looking at the positive response from the market, Towa expanded its activities and ventured into biomedical and biotechnology research market. More than 50 percent of the revenue of the company comes from the microscopy division. As per the company management, its future plan for 2014-15 will be to continue with quality equipment and dedicated customer service, enabling us to propel and be ready for the next phase of growth. ]]> https://biospectrumindia.com/news/97/5107/india-the-best-place-to-study-drug-responses.html https://biospectrumindia.com/news/97/5107/india-the-best-place-to-study-drug-responses.html Fri, 12 Sep 2014 16:44:42 +0530 In his presentation, eminent guest Prof. Samir K Brahmachari said that the Indian genome is a melting pot of the world population. "India is the best place to study drug-responses and drug-reactions in clinical trials. Our country has a large and diverse population coupled with good IT application capability. If we do not take advantage of NGS, then India is less likely to be successful in the global arena. Our major weakness is failing to publish our research works and papers," he opined. Earlier, genome sequencing cost around $3 million. Currently it is down to $1000, which perhaps will reduce even more in the years to come, Prof. Brahmachari revealed. Dr Raja C Mugasimangalam, founder and CEO, Genotypic Technology told BioSpectrum, "We are in the NGS era and we need to learn to apply it. We want to be the genomics technology hub, where technology companies, colleges, mobile application developers, entrepreneurs, doctors, and everyone can be a part. We need to learn to collaborate since it is not a one-man show." The NGS data analysis and interpretation market in India is estimated to be $100 million. According to Dr Raja, NGS in India is doing better than anywhere else in the world. "This is the next enabling technology wave and we can't stop it. Its applications vary from pharma to agriculture, and basic science to clinical trials," he explained. Dr Raja feels that students have to get into more of analyzing and interpreting NGS data. He revealed, "This is the future. Technically, biotechnology has died. The next wave is in genomics and genome-informatics. We are depending too much on the West for equipment and machines in NGS technology, which needs to reduce. However, for data interpretation, we are the kings."   Dr Venkatesh Krishnamurthy, research director, Genotypic Technology said that this conference will be a one-stop platform for people interested in NGS. "The conference will provide an idea of current happening trends in NGS. People can fine-tune their existing knowledge and pick-up dynamic projects. This event has made it possible for the industry and academia to come together as one cluster for further growth," added Dr Krishnamurthy. Genotypic Technology has inked a pact with Manipal University, an R&D collaboration in clinical diagnostics. Last year, it also signed an MoU with VIT. The company is also in the process of singing another MoU with NIMHANS (National Institute of Mental Health and Neurosciences), which is expected to reach fruition very soon.   ]]> https://biospectrumindia.com/news/97/4439/waters-unveils-global-mass-spectrometry-headquarters.html https://biospectrumindia.com/news/97/4439/waters-unveils-global-mass-spectrometry-headquarters.html Fri, 12 Sep 2014 14:57:00 +0530 Waters has announced the launch of its new, custom-built mass spectrometry headquarters at Wilmslow, the UK. The center was inagurated by the CEO Mr Doug Berthiaume and the Honourable Mr George Osborne, MP.The 2313m² building, which took less than two years to build, comes equipped with state-of-art customer demonstration laboratories, research and development capabilities and an expanded manufacturing capacity. The center, which has been constructed to a very good BREEAM rating also has features like rain water harvesting tanks, solar panels, and heat recovery systems. This center brings together Waters' existing mass spectrometry centres in the region consisting of more than 500 employees.  Mr Brian Smith, VP, Mass Spectrometry Operations at Waters commented, "Our new Waters Mass Spectrometry Headquarters in Wilmslow marks our continued investment in the region and dedication to the North West. The new facility has been specially designed to enhance collaboration and drive innovation, building on the research and scores of patents that we have already accomplished in the field, right at the heart of where mass spectrometry first began, here in Manchester." Waters has expanded its mass spectrometry portfolio significantly in the recent past, with the introduction of new advanced instruments. ]]> https://biospectrumindia.com/news/97/5073/maymygenome-strikes-deal-with-snapdeal.html https://biospectrumindia.com/news/97/5073/maymygenome-strikes-deal-with-snapdeal.html Fri, 12 Sep 2014 13:20:19 +0530 The service is said to offer genomic services predicting diseases and directing patients towards more effective medicines. "....We wanted to reach out to more people and ecommerce is much easier way to reach," expressed Ms Anu Acharya, CEO, Mapmygenome." Most clients for this service hail from major metros. However, people from other emerging towns like Coimbatore, Vijayawada, and Kharagpur have also started using this service for screening a variety of diseases like CVDs and Alzhiemer's. "....The collaboration will help us in reaching out to over 25 million members across the country and enable them to understand the gene-disease interaction better," commented Mr Amit Maheshwari, VP, Snapdeal.com. ]]> https://biospectrumindia.com/features/97/5583/premas-registers-nearly-132-percent-growth.html https://biospectrumindia.com/features/97/5583/premas-registers-nearly-132-percent-growth.html Thu, 11 Sep 2014 16:35:27 +0530 Posting revenue of Rs 66 crore, Premas lifesciences,a provider of industry leading molecular technologies, registered good growth in the last fiscal year. The firm's diverse product portfolio encompassing an array of high end genomics equipment and associated services has generated waves in the genetic diagnosis and research markets. Apart from lifesciences, Premas' venture into agro,food testing and forensic testing sectors played an instrumental role in boosting the firm's revenue.Premas Lifesciences provides integrated research solutions that accelerate and solve complex lifescience challenges, improves patient diagnosis and increase laboratory productivity. In the last fiscal year, the firm unveiled its wide range of innovative products catering to the major disciples of lifesciences. The firm's latest offerings included Next Seq 500 from Illumina and C1 autoprep from Fluidigm apart from newer products like vectors, drug metabolism enzymes, reporter gene assays and nucleic acid purification kits. Premas has completed its seventh year of association with Illumina India and has retained its distributorship from Illumina on all India operations. The firm was also chosen for a best distributor award for 2013. The company sold 25 NGS instruments in a calendar year. Nearly 24 percent of its business comes from the private sector. Moving ahead, the firm plans to achieve 22 percent growth in revenue by exploiting markets in newer areas of lifesciences like cell biology and targets to create a consumables division apart from the existing instrumentation business. Premas also aims to tap the lucrative genomics market and is also eyeing on collaborating with international companies for global expansion. ]]> https://biospectrumindia.com/news/97/4727/apple-launches-a-new-pulse-reading-smart-watch.html https://biospectrumindia.com/news/97/4727/apple-launches-a-new-pulse-reading-smart-watch.html Thu, 11 Sep 2014 12:28:37 +0530 The much-awaited smart-watch, loaded with features, marks the entry of the mobilephone giant into the healthcare wearable market. The device not only offers users the ability to tell time but also includes sensors that can detect a pulse, count steps, and suggest fitness goals. There are also a gyroscope and an accelerometer, which help provide a comprehensive picture of the daily routine of the wearer. The watch has two fitness apps; an activity app which gives users an overview of their daily fitness levels, like calories burned, exercise done etc. And a workout app, which shows real-time statistics like time, distance, calories, and pace during exercise. It could act as a personal trainer, pointing out fitness goals and other tips. According to Apple, it is the most personal device the company has created. The watch will be available in the market early next year with a price tag of $349.   ]]> https://biospectrumindia.com/news/97/4731/agilent-launches-a-new-spectroscopy-system.html https://biospectrumindia.com/news/97/4731/agilent-launches-a-new-spectroscopy-system.html Thu, 11 Sep 2014 12:01:27 +0530 The Agilent Cary 8454 UV-Visible spectroscopy system includes a UV-Visible instrument based on leading LC photodiode array detector technology. The new Agilent Cary 8454 UV-Vis is fast, robust, reliable, and comes equipped with a powerful software to make compliance even easier. The Updated ChemStation software, now integrated with OpenLAB ECM includes enhanced audit trails, and supports customized user profiles. The company offers a comprehensive portfolio of service plans and regulatory compliance services to help achieve validation of the 8454 UV-Visible system and its components to ensure the highest levels of reliability and performance. Agilent Cary 8454 gives results across the entire UV-Vis spectrum in less than one second. It is designed to meet the requirements of both initial and recurrent validation. Agilent offers a seamless upgrade for Agilent 8453 and 8452 users.   ]]> https://biospectrumindia.com/news/97/4729/cpc-expands-its-portfolio-in-india.html https://biospectrumindia.com/news/97/4729/cpc-expands-its-portfolio-in-india.html Thu, 11 Sep 2014 11:50:29 +0530 Colder, according to a press release, has announced the launch of its MPC and MPX quick disconnect product lines in India. These product lines include back-to-back body adapters and sanitary inserts. They offer greater flexibility in combining single-use components and systems to biopharmaceutical manufacturers. "CPC's MPC and MPX quick connects are already an industry standard in North America and Europe, and are rapidly becoming the prevailing solution in India as well due to growing customer interest in expanded options such as back-to-back body adapters and sanitary inserts," said Mr Ernest Chan, director of sales, Asia Pacific, CPC. He added, "End-users will benefit from the added process flexibility of making quick and secure transitions between standard sanitary fittings and quick connects as well as easily combining systems that incorporate different tubing sizes." CPC's MPC and MPX back-to-back body adapters enable end users to connect off-the-shelf single-use systems that feature male coupling inserts and can be used in a wide range of applications such as fermentation sampling, modular tubing manifolds, and lab scale additions. These are made up of polycarbonate and polysulfone materials. The products meet USP Class VI and ADCF requirements and are manufactured in an ISO Class 7 certified cleanroom.   ]]> https://biospectrumindia.com/news/97/4422/first-fda-cleared-mobile-ecg-offered-in-india-.html https://biospectrumindia.com/news/97/4422/first-fda-cleared-mobile-ecg-offered-in-india-.html Wed, 10 Sep 2014 16:22:32 +0530 Through an exclusive agreement, Apollo Hospitals and AliveCor will tackle the growing problem of heart arrhythmias. The AliveCor Heart Monitor is compatible with iOS and Android mobile devices to wirelessly record, display, store and transfer heart-rate and single-channel electrocardiogram (ECG), the electrical activity of the heart. Dr Prathap C Reddy, chairman, Apollo Hospitals said, "....It's extremely important for us to provide access to medical devices that are both clinically proven and cost-effective to help our patients manage their cardiac health..." ]]> https://biospectrumindia.com/news/97/4329/toshiba-johns-hopkins-to-collaborate-for-big-data-research.html https://biospectrumindia.com/news/97/4329/toshiba-johns-hopkins-to-collaborate-for-big-data-research.html Wed, 10 Sep 2014 11:29:08 +0530 To utilise the potential of Big Data to predict and prevent diseases, Toshiba has established a 'Toshiba Center for Big Data in Healthcare' at Johns Hopkins University. The center's main project is to study treatment pathways and outcomes in head, neck, and lung cancer patients in collaboration with the Johns Hopkins radiation oncology department. "Toshiba recognizes the ability of Big Data to monitor individual health, and in the future, to support day-to-day clinical decision making. With our collaboration at Johns Hopkins, we hope to create a new paradigm in medicine that transforms healthcare into a more efficient, cost-effective, and data-driven enterprise that will help to improve patient outcomes," said Mr Rich Mather, director, Clinical Programs, Toshiba Medical Research Institute. Mr Satoshi Tsunakawa, executive officer, corporate senior vice-president of Toshiba added, ''This is a great opportunity to work with Johns Hopkins, one of the world's leading medical centers, and I am confident that the research will lead to improvements in prevention, diagnosis, treatment, and prognosis of disease, and help promote better health for patients in the US and around the world." 'Toshiba Center for Big Data in Healthcare' will create new technologies to monitor individual health and drive more precise, individualized patient care.   ]]> https://biospectrumindia.com/news/97/6671/a-new-pipetting-solution-by-eppendorf.html https://biospectrumindia.com/news/97/6671/a-new-pipetting-solution-by-eppendorf.html Wed, 10 Sep 2014 10:26:00 +0530 The new epMotion 96 from Eppendorf provides an ideal, time-saving solution when working with 96 or 384-format microplates or deep-well plates in lifescience research, pharmaceutical, and industry laboratories. It allows easy, rapid handling with high precision and accuracy compared to multi-channel manual pipettes. It can dispense into 96 wells at the same time, making it possible to simultaneously start or stop a biological assay for all the wells in a plate. "The latest addition to the Eppendorf epMotion range allows pipetting tasks to be completed faster and more precisely. With the new epMotion 96, you can pipette entire 96-well plates at once, which makes a huge difference to productivity and efficiency," said Dr Carsten Buhlmann, international product manager, Eppendorf. The epMotion 96 has a volume range between 0.5 and 300μL. It comes with the eppendorf software concept and a touch screen control. Its small footprint makes it suitable for use in busy laboratories.     ]]> https://biospectrumindia.com/news/97/5472/polymedicure-wins-patent-battle-against-b-braun.html https://biospectrumindia.com/news/97/5472/polymedicure-wins-patent-battle-against-b-braun.html Tue, 09 Sep 2014 15:14:27 +0530 PolyMedicure, a manufacturer of medical devices has won its five-year long patent battle against German medical devices and pharma giant, B Braun. The German firm had sued the company for alleged patent infringement for its intravenous (IV) safety catheters. The European Patent Office (EPO) has now revoked two of B Braun's patents. The company believes that this victory will help them gain a firm foothold in Europe. The European safety catheter market is seen at $250 million. Mr Rishi Baid, director, Poly Medicure said in a statement, "The two concerned patents have been revoked by the European Patent Office, as per our information and it is likely that this will have a huge positive impact on our business in Europe."     ]]> https://biospectrumindia.com/news/97/7305/health-apps-educate-kids-though-games.html https://biospectrumindia.com/news/97/7305/health-apps-educate-kids-though-games.html Tue, 09 Sep 2014 15:09:00 +0530 In line with the recent trend of gamification, many digital health companies are mushrooming to develop new apps that can help kids to learn and manage their health. Recently, Sanofi diabetes in collaboration with a Canadian health games company Ayogo, launched an app called Mission T1D in the UK, for kids suffering from juvenile diabetes, their parents and caregivers. The app is a virtual school setting that helps kids to gain knowledge about diabetes, as they clear new levels. The players have to earn points to unlock short easy-to-remember tips about living with type-1 diabetes. The game also includes educational videos and quizzes that cover basics of juvenile diabetes and hypoglycemia. Another health app created by this partnership was Monster Manor, that was shortlisted in the Health Service Journal (HSJ) Value for Healthcare Awards. Wellapets is yet another educational app that helps kids manage juvenile asthma. The game is a virtual pet and kids have to teach the pet better inhaling techniques and asthma triggers. In all the games, kids take up the role of a doctor in order to gain a proactive perspective that can help them afford a sense of control over their health. ]]> https://biospectrumindia.com/news/97/5414/whats-boschs-next-move-in-healthcare-space.html https://biospectrumindia.com/news/97/5414/whats-boschs-next-move-in-healthcare-space.html Tue, 09 Sep 2014 10:42:50 +0530 In August 2014, Bosch launched its eye screening and detection system in Bangalore, developed primarily for the Indian market. The launch grabbed uncountable eyeballs across industries wondering about the company's decision to venture in to healthcare. "As an organization mobility solutions and automotive are our major focus areas. We are already in the healthcare space through telemedicine platforms in the US and Europe. So our focus in India is to solve problems that are relevant to India, and not being concerned about what areas of business we are in. We believe we can bring in lot of technology practices that are relevant to the Indian market. So healthcare is our big focus area and you will see more innovations in the future," explained Mr Harsha Angeri, senior GM and lead, strategy and business development The product is already available in the market and is priced at Rs 2.44 lakh, including the hardware and software components but excluding the algorithm. The product has taken about 1.5-2 years to develop, according to Bosch. When asked about the products' affordability factor, Mr Angeri said, "If you compare our product with what is available, this would be the most competitive price in the market. We have significantly changed the affordability equation."   The company acknowledged that it has both local and global competitors, who offer similar devices in various other forms. The company's primary target includes individual practitioners ranging from ophthalmologists to general physicians. "Our strategy is to go to the mass market and appeal to individual practitioners. Secondly, we are talking to multiple major institutions who have been validating this device on their own in their settings," expressed Mr Angeri. Talking about Bosch's future healthcare innovations, he added, "We want to bring in a portfolio of more products in this space. We will also look at other medical conditions in a broader way. We'll address them and announce when we are ready to launch." Mr Angeri also said that the newly launched device will witness more features being embedded in to it and simultaneously bring down the device's cost. "We are also investing in technologies by adding additional features that will further enhance the way this device works," he commented. Right now, Bosch doesn't have any intention to export the product. "Our focus is to address the problem in India. The issue is prevalent in other regions also. We want to first ensure that this product works in India, and then take the learnings and decide how to focus on other markets." ]]> https://biospectrumindia.com/news/97/5317/ppd-acquires-patented-clinical-trial-design-technology.html https://biospectrumindia.com/news/97/5317/ppd-acquires-patented-clinical-trial-design-technology.html Mon, 08 Sep 2014 11:35:15 +0530 Pharmaceutical Product Development (PPD), a global CRO firm has announced that it has acquired RCT Logic's exclusive license from Massachusetts General Hospital (MGH) for the portfolio of patents related to its sequential parallel comparison design (SPCD). SPCD is an alternative method for conducting well-controlled clinical trials. PPD is branding it as Trimentum. It has been effective in studying major depressive disorder (MDD), but is also applicable to other clinical trials. "Through Trimentum, PPD can offer our clients a clinical trial method that derives more information from fewer patients. As a result, our clients will be able to conduct smaller, more efficient trials in all stages of drug development, enabling more informed investment decisions and accelerating the delivery of much-needed new medicines," said Mr Daniel Burch, PPD vice president of global product development and therapeutic area head for neuroscience. He added, "The pharmaceutical industry and regulatory agencies have long recognized the need for a more robust and efficient option for conducting clinical trials. We anticipate that these and other stakeholders will be receptive to the design and apply it to appropriate clinical settings." Mr Matthias Bowman, founder, RCT logic said, "Having one of the world's leading contract research organizations continue to build on the success of SPCD is a great achievement for RCT Logic. We are excited that PPD will be able to help its clients accelerate the pace and reduce the cost of developing new medical therapies through the use of MGH's patented SPCD technology. We are particularly enthusiastic about the implications for patients who are waiting for important new treatments."     ]]> https://biospectrumindia.com/news/97/5240/brain-to-brain-communication-in-humans-might-be-possible.html https://biospectrumindia.com/news/97/5240/brain-to-brain-communication-in-humans-might-be-possible.html Sun, 07 Sep 2014 17:38:00 +0530 A team of scientists from Harvard University Medical School and experts from France and Spain have successfully transmitted information via the internet between two human subjects located 5000 miles away. The transmission was from India to France. The computer-mediated transmission could be made possible using internet-linked electroencephalogram (EEG) and robot-assisted and image-guided transcranial magnetic stimulation (TMS) technologies. The study was conducted on four healthy participants, in the age-group of 28-50 years. The device connects directly to the users' scalps and impulses from the sender were picked up via electroencephalogram (EEG) as well as by an image-guided and robot-assisted transcranial magnetic stimulation (TMS). The signal was encoded and sent via the internet to the user on the other end. Once it reached its target destination, the code was then interpreted by a computer interface and delivered to the recipient. The binary messages were then decoded as 'Hola' and 'Caio'. "We wanted to find out if direct communication was possible between two people by reading out the brain activity from one person and injecting brain activity into the second person, and do so across great physical distances by leveraging existing communication pathways," said co-author Mr Alvaro Pascual-Leone in a statement. The study is published in the Journal PLOS One. ]]> https://biospectrumindia.com/features/97/6862/banking-on-core-competence-advanced-microdevices-.html https://biospectrumindia.com/features/97/6862/banking-on-core-competence-advanced-microdevices-.html Sun, 07 Sep 2014 14:33:00 +0530  Advanced Microdevices (MDI) is a leader in innovative membrane technologies. Starting from a single person R&D operation in 1976, MDI has developed into a dedicated team of 300 personnel with more than 15,000 products. The company has created a niche for itself in the world market by developing latest technologies at low cost and commercializing internationally accepted products at competitive prices. Continuing to grow, the company recorded an estimated Rs 102 crore revenue in the FY 2013-14 as compared to Rs 91 crore in the last fiscal year. The company has been growing at a double digit rate annually and it is expected to maintain the same in the coming years. MDI has grown into a vertically integrated company that helps deliver prototypes rapidly for quicker movement of products to the market. It has a unique interdisciplinary expertise which allows it a very fast turnaround in developing new and customized products for its customers. The focus at MDI is on using its membrane technologies as a platform for developing new value added products for use in filtration and separation. The membranes ranging from Nitrocellulose, Nylon, Polyethersulfone, PTFE, and PVDF along with glassfibre and polypropylene separation material are being manufactured. The company's products are used for sterilization of injectable drugs, for sterility testing, for sample preparation of drugs that are tested with highly sophisticated instrumentation, for the development of new drugs, for making reliable immunoassays used in testing diseases at a patient's bedside. The company's core competence is its ability to develop new membrane technologies and innovate existing ones to deliver customer benefits.     ]]> https://biospectrumindia.com/features/97/5230/genetix-banking-on-product-diversification-.html https://biospectrumindia.com/features/97/5230/genetix-banking-on-product-diversification-.html Sun, 07 Sep 2014 12:55:00 +0530  In FY 2013-14, Genetix recorded a revenue of Rs 105 crore as compared to Rs 96crore in the previous fiscal. The company has a track record of being an established and preferred distributor to most of the private, government, and defence customers. Apart from that, the company has been trying to build its ownbrand by introducing world class quality products at most affordable prices.Genetix initially started as an indenting company for marketing and providing technical support to Indian customers when most federal government funded customers in India preferred to order directly from the suppliers, as they enjoyedcustom duty exemption for research and development. The company represents market world leaders in biotechnology/lifesciences, laboratory, research products such as, filtration membranes and devices, molecular biology kits and reagents, biochemistry, protein assays, fine chemicals, immunology reagents, cell and tissue culture, serum and media, chromatography accessories, and various instruments for leading multinational brands.Since early nineties, Genetix Biotech Asia revolutionized the biotech research consumables supplier's industry business in India by taking a major initiative to import and stock a wide range of chemicals, reagents, enzymes, kits, laboratory plastic wares, instruments, chromatography columns, resins, and molecular diagnostic products. It represents world's leading companies (viz Thermo Fisher, Santa Cruz, Tosoh Bioceph, Microflex GE Life Sciences, and Perkin Elmer) spread across 3 continents. It claims to be the most preferred supplier to universities, biotech research institutes, vaccine manufactures, and also to a number of top hospitals andprivate nursing homes.       ]]> https://biospectrumindia.com/features/97/7420/eppendorf-looking-to-enter-the-consumables-market.html https://biospectrumindia.com/features/97/7420/eppendorf-looking-to-enter-the-consumables-market.html Sat, 06 Sep 2014 13:34:00 +0530 Eppendorf is a lifescience company developing and selling instruments, consumables, and services for liquid samples and cell handling in laboratories worldwide. For the FY 2013-14, Eppendorf India generated Rs 114.5 crore revenue. This year marks its presence for the past 14 years in India.Its product range includes pipettes and automated pipetting systems, dispensers, centrifuges, mixers, spectrometers, and DNA amplification equipment as well as ultra-low temperature freezers, fermentors, bioreactors, Co2 incubators, shakers, and cell manipulation systems. Associated consumables like pipette tips, test tubes, microtiter plates, and disposable bioreactors complement the instruments for highest quality workflow solutions. Eppendorf products are most broadly used in academic and commercial research laboratories, and in companies from the pharmaceutical and biotechnological, and as well as the chemical and food industries.They are also aimed at clinical and environmental analysis laboratories, forensics, and at industrial laboratories performing process analysis, production, and quality assurance.According to Eppendorf, it has plans to foray into tissue culture consumables with innovative and convenient plates, dishes and flasks. Its product launches during the period under review include Mastercycler Nexus X2 series, Thermomixer C, Thermomixer FP, Thermomixer F1.5, Multipette M4, Reference 2, Assay/Reader plates, ep Dualfilter TIPS SealMax, and Serological pipettes.   ]]> https://biospectrumindia.com/features/97/5845/the-largest-supplier-of-packaging-for-injectables-in-apac.html https://biospectrumindia.com/features/97/5845/the-largest-supplier-of-packaging-for-injectables-in-apac.html Sat, 06 Sep 2014 13:12:00 +0530 West Pharmaceutical Packaging India, a subsidiary of West Pharmaceutical Services, recorded good performance touching estimated revenue of Rs 8,200 crore globally for 2013-14. In 2012, registering over 19.4 percent growth. West provides innovative solutions for injectable drug administration for pharmaceutical and solutions for drug packaging, administration and delivery systems. The company has been in business for 90 years in the US, and it is the largest global supplier of primary packaging for injectable medicines components in the APAC region. Its recently launched quintessential products include West Spectra Seals, Daikyo Crystal Zenith, Needle Safety Systems, Administration Systems, NovaPure Components, Westar Processing and Injection System Platform Technologies. In addition, West has promoted proprietary self-injection systems including the SmartDose electronic wearable injector, SelfDose injector, ConfiDose auto injector and Nova-Guard needle safety systems.The world's top 35 biologics, whose 2012 sales were $108.5 billion, are now being packaged and delivered with components manufactured by West and its partner, Daikyo Seiko. In July 2014, West commissioned its first manufacturing facility in India,which is a pharmaceutical seals manufacturing unit in Sri City SEZ in Chennai. The facility has an annual capacity of manufacturing one billion seals, and was erected with an investment of $15 million from company.This plant will involve 100 percent exports currently employing 45 professionals       ]]> https://biospectrumindia.com/news/97/5066/a-novel-invitro-cloning-platform-by-agilent.html https://biospectrumindia.com/news/97/5066/a-novel-invitro-cloning-platform-by-agilent.html Sat, 06 Sep 2014 11:24:00 +0530 Agilent technologies has announced the launch of SureGuide Kits, a technology which represents the first integrated solution for In-Vitro CRISPR/Cas9 Research, with gRNA design and gRNA synthesis. The SureGuide family of tools will enable in-vitro cloning of large genes or complex DNA mixtures without the limitations imposed by common restriction enzymes or PCR fidelity. "SureGuide provides a simple, integrated tool set designed to expand access to this remarkable technology by making it easier for scientists to integrate CRISPR/Cas9 in their everyday cloning workflows," said Mr Alessandro Borsatti, senior director, marketing, Agilent's diagnostics and genomics solutions. He added, "SureGuide enables truly programmable, customizable cloning specificity while improving on the efficiency scientists expect from current nuclease technologies." It is the first product in the company's genome editing and engineering portfolio. The company will be releasing other products specifically targeted to synthetic biology and functional genomics.     ]]> https://biospectrumindia.com/news/97/5080/agilent-inks-pact-with-shimadzu.html https://biospectrumindia.com/news/97/5080/agilent-inks-pact-with-shimadzu.html Fri, 05 Sep 2014 17:33:56 +0530 Agilent Technologies and Shimadzu have announced a partnership which will enable them to control the GC instruments for their respective chromatography data systems. The move provides customers in analytical laboratories with more freedom of choice when selecting a chromatography data system. Agilent has released drivers for the Shimadzu GC-2010, GC-2010 Plus and GC-2014 integrating it to Agilent's OpenLAB CDS;while Shimadzu has released drivers to control Agilent 6890, 6850, 7820, and 7890 GC instruments in Shimadzu's Lab Solutions. These releases are the result of the joint collaboration employing Rapid Control (RC.NET) instrument drivers, which the companies announced last year. "Agilent continues to follow an open-system approach for the laboratory to deliver value to our customers," said Mr Bruce von Herrmann, vice president and general manager of Agilent's software and informatics business. He added, "To reduce costs and enhance customer experience, we are working with other manufacturers, such as Shimadzu, to enable full and reliable control of lab instrumentation from any CDS. These new releases demonstrate that Rapid Control is the predominant industry standard for analytical instrument control." Mr Masahito Ueda, general manager of the GC and TA business Unit, analytical and measuring instruments division, Shimadzu said, "At Shimadzu, we continue to deploy industry-standard drivers for instrument control to provide flexible instrumentation and software solutions for our customers. The adoption and support of RC.NET drivers provide a more integrated solution to customers who require a single CDS product to support seamless multi-vendor control of all instruments in their laboratory."   ]]> https://biospectrumindia.com/features/97/5059/imperial-consistent-growth-through-the-year.html https://biospectrumindia.com/features/97/5059/imperial-consistent-growth-through-the-year.html Fri, 05 Sep 2014 12:17:00 +0530 Despite facing adverse market conditions, Imperial Life Sciences (ILS) has been able to maintain double digit growth year after year. Displaying an impressive growth rate, the company has registered a revenue of Rs 212 crore as against Rs 187.17 crore in the previous fiscal year. Being an exclusive representative of many leading global players in India, ILS provides complete solutions in instrumentation, reagents, bioinformatics, and consumables. Besides that, it has an entire range of products for labs working in genomics, proteomics, cell culture4, drug discovery, and bioproduction. The company aims at continuing growth in current business segments besides establishing a new healthcare business. Among the recent initiatives, it launched a new healthcare division for further expansion of business taking its vision from bench to bedside. During the year, ILS successfully collaborated with companies like MI Labs, MR Solutions, Sage Biosciences, Denovix, Chemagin, and Perkin Elmer to offer additional aid to help fulfill the research needs of the Indian scientific community. The company has facilitated some major projects all over India by providing services through the processing of samples on India's first Gene Titan MC Instrument (automated microarray platform for high end agri-genomics and human genetics) placed at its own facility in Gurgaon. Expanding its horizons, ILS has moved into third generation sequencing by tying up with Pacific Biosciences, leading manufacturers of world's first single molecule real time DNA sequencing system called third generation sequencers. The company is also looking at utilizing the deficit in terms of technologies available in the advanced molecular diagnostics space. It has tied up with Affymetrix which focuses on personalized diagnostics in a big way and brings the FDA-cleared assays aimed at hospitals and clinicians to India. It also plans to expand its portfolios in genomics, molecular imaging, and spectroscopy. ILS collaborated with market leaders in different segments of the business. Other collaborations of the company were with Affymetrix for microarray systems and arrays, NEB for their extensive range of molecular biology reagents including restriction enzymes, polymerases etc. and GMI with its state of the art PET/SPECT/CT. The company also partnered with Miltenyi Biotec for their MACS Quant flow cytometer, AutoMACSPro cell separator, and extensive portfolio of cell biology reagents. As per company management, the product range from New England Biolabs and Affymetrix have been significant business drivers for the company. Caliper and Miltenyi Biotec have been significant revenue generators. Revenue from the consumables business has increased significantly with the segment contributing as much as instrumentation.   Having merged reagents and the instrumentation teams, ILS has doubled its strength and penetration into the Indian market and is constantly investing in growth. With its increased product portfolio, the company has now diversified its business by creating individual business groups viz. genomics division, cell biology and imaging division, and consumables and reagents division with separate focused teams for giving special focus to specific applications and overall growth of the company.     ]]> https://biospectrumindia.com/news/97/5044/pharma-giants-explore-ibm-watsons-role-in-drug-development.html https://biospectrumindia.com/news/97/5044/pharma-giants-explore-ibm-watsons-role-in-drug-development.html Fri, 05 Sep 2014 10:20:57 +0530 Leading lifesciences organizations are deploying Watson Discovery Advisor to advance discoveries in ongoing research projects, including Baylor College of Medicine, Johnson and Johnson and The New York Genome Center. Sanofi is exploring how working with Watson can speed up the discovery of alternate indications for existing drugs (drug re-purposing). Watson is able to understand and extract key information by reading millions of pages of scientific literature and then visualizes relationships between drugs and other potential diseases they could target while providing supporting evidence each step of the way. Drug safety and toxicity is a major driver of the high failure rate in clinical development and trials. Sanofi is exploring how Watson's ability to understand, extract and organize toxicological information can enable researchers to make better informed decisions with respect to candidate progression.   Johnson & Johnson is collaborating with the IBM Watson Discovery Advisor team to teach Watson to read and understand scientific papers that detail clinical trial outcomes used to develop and evaluate medications and other treatments. This collaboration hopes to accelerate comparative effectiveness studies of drugs, which help doctors match a drug with the right set of patients to maximize effectiveness and minimize side effects. "We're entering an extraordinary age of data-driven discovery," said Mr Mike Rhodin, senior vice president, IBM Watson Group. "Today's announcement is a natural extension of Watson's cognitive computing capability. We're empowering researchers with a powerful tool which will help increase the impact of investments organizations make in R&D, leading to significant breakthroughs." IBM Watson will be supporting the analysis in New York Genome Center's clinical study to advance genomic medicine. The clinical study will initially focus on clinical application of genomics to help oncologists deliver DNA-based treatment for Glioblastoma. ]]> https://biospectrumindia.com/features/97/5774/shimadzu-a-key-player-in-the-lifescience-market.html https://biospectrumindia.com/features/97/5774/shimadzu-a-key-player-in-the-lifescience-market.html Thu, 04 Sep 2014 14:58:06 +0530 Shimadzu, a global leader in the manufacturing of analytical instruments, focuses at developing the state-of-art technology, creating novel solutions for thelifesciences sector. With multitude of innovative products, encompassing analytical and measuring instruments, medical systems and industrial equipment, Shimadzu is a key player in the Indian lifesciences supplier market. The last fiscal saw Shimadzu Analytical India launching a series of new innovative products in the market. The company gained a sizeable market share with its newintegrated I-series LC system. By launching its new product GCMSTQ8040 Gas Chromatograph Mass spectrometer, Shimadzu strengthened its position in the analytical products market. Few other products launched by the firm includedLCMS-8050, Crude2Pure System that featured excellent productivity, attracting the attention of global pharma, and other lifescience companies. Few of the other major achievements of the firm included the completion of a new quality center to promote the provision of high quality reliable products. Though the firm focused on lifesciences, it is also constantly cultivating new business opportunities in global energy, automotive and IT by promoting leading-edge seed   technology development. One such initiative by the company was establishing a strategic collaboration with the National University of Singapore Environmental Research Institute, to conduct research on environmental contaminants. Shimadzu recently launched its new high resolution scanning probe microscope SPM-8000FMto cater to the needs of nanotech industries.  Extensive research and innovation by the firm has helped develop newer products and services to compete in the market. The firm's recent research on monoclonal antibodies was considered as a breakthrough in the field of medical technology.   ]]> https://biospectrumindia.com/news/97/5025/another-us-fda-approval-in-ges-portfolio.html https://biospectrumindia.com/news/97/5025/another-us-fda-approval-in-ges-portfolio.html Thu, 04 Sep 2014 14:34:55 +0530 The Unites Stated Food and Drug Administration (US FDA) has approved GE healthcare's latest technology SenoClaire, a new tomosynthesis solution designed using three-dimensional imaging technology. "With the FDA's approval of SenoClaire, we build on our breast care continuum which offers physicians and patients a complete suite of solutions, ranging from screening and diagnosis through treatment, and monitoring," said Ms Catherine Tabaka, chief marketing officer, detection and guidance solutions, GE Healthcare. She added, "SenoClaire not only offers patients a new solution to help clinicians better detect breast cancer, but does so with low dose radiation and high image quality. This new generation technology, breast tomosynthesis, together with innovative solutions like contrast enhanced spectral mammography, automated whole breast ultrasound, and molecular breast imaging will equip health care providers with a comprehensive set of tools that will help patients across the entire breast care continuum." GE has developed this technology in collaboration with the Massachusetts General Hospital. "Today's announcement marks a key milestone in our mission of providing women with cutting edge screening technology to detect early breast cancer. When cancer is identified and treated earlier, we know women have a better rate of survival," said Dr Daniel Kopans, senior radiologist, breast imaging division, department of radiology, Massachusetts General Hospital.   ]]> https://biospectrumindia.com/news/97/7043/johnson-and-johnson-to-sell-its-medical-device-unit.html https://biospectrumindia.com/news/97/7043/johnson-and-johnson-to-sell-its-medical-device-unit.html Thu, 04 Sep 2014 11:20:00 +0530 Johnson & Johnson (JNJ), world's largest maker of healthcare products, is planning the sale of its medical device unit Cordis, say reports. The Cordis unit focuses on less-invasive treatments for vascular diseases and other devices including stents and catheters. The company pioneered cardiac stents, global market for which is worth $5 billion. It employs around 5,000 people. The unit could fetch the company about $2 billion and is expected to attract interest from private-equity firms and other healthcare companies. Reportedly, the unit's slow growth have prompted JNJ to consider this action, as the company want to focus on other medical technologies promising higher growth. The sale would reduce its annual costs by $1 billion. Earlier this year, the company sold its ortho-clinical diagnostics business for about $4 billion.   ]]> https://biospectrumindia.com/news/97/4983/eu-approval-for-ges-vizamyl.html https://biospectrumindia.com/news/97/4983/eu-approval-for-ges-vizamyl.html Wed, 03 Sep 2014 16:51:00 +0530 GE healthcare's radiopharmaceutical product VIZAMYL (flutemetamol (18F)) a Positron Emission Tomography (PET) imaging system, used to detect amyloid plagues has received the European Union's approval. It is the only PET imaging tracer that has been approved by the regulatory body. However, VIZAMYL is for diagnostic use only and should be used in conjunction with a clinical evaluation. "Dementia is one of the biggest health and social challenges in the world and receiving marketing authorisation for VIZAMYL in the European Union (EU) demonstrates our continued commitment to help meet this challenge and support the diagnosis of Alzheimer's disease" said Mr Kieran Murphy, president and CEO, Lifesciences, GE Healthcare. He added, "This approval will provide physicians in EU with an important tool that may help them better assess specific patients, who are being evaluated for Alzheimer's disease and will also support further research into greatly needed disease modifying agents." VIZAMYL can detect the accumulation of beta amyloid in the brain, which will help confirm an Alzheimer diagnosis and also in determining appropriate treatment plans. It will be commercially available in Europe from early next year.   ]]> https://biospectrumindia.com/features/97/4892/himedia-riding-on-the-innovation-wave.html https://biospectrumindia.com/features/97/4892/himedia-riding-on-the-innovation-wave.html Wed, 03 Sep 2014 13:18:36 +0530 Maintaining its consistent performance, HiMedia has registered a revenue of Rs 394.45 crore for the last fiscal year. Riding high on the innovation wave, HiMedia has extended its expertise in innovating world-class products in animal and plant tissue culture media and molecular biology. The last fiscal year was successful for the firm both in terms of innovation and expansion. In addition to the existing robust product portfolio, the firm introduced a complete new product line of granulated and capsule media into the market. This has helped the firm attract lifescience players and pharma giants worldwide. With culture media compliant to all major pharmacopeias worldwide, HiMedia products are an integral part of almost all pharma and biotech labs across the globe. Moving ahead, the firm aims to become a one-stop solution provider for lifesciences. After attaining remarkable success with culture media and cell lines for microbiology and molecular biology labs, HiMedia is all set to pioneer and shape a paradigm shift from culture media products to instrumentation for molecular biology and microbiology laboratories. The firm is currently focused on taping the emerging agro market by developing an innovative plant nutrient product pipeline to cater to the needs of various agro and nutrition based industries. Its novel rose multiplication medium has already generated waves in the floriculture market. Besides these, HiMedia has launched various nutrition testing kits to aid testing labs assess the quality and nutritional value of food. The milk adulteration kit launched by the firm has become very popular among healthcare experts as it is capable of detecting 17 adulterants in milk with increased authenticity. Though the firm's research endeavors were hindered by the lack of funds from the government and the unstable political scenario in the country, HiMedia raked in profits as the consumption of media products, readymade cell culture plates and cell lines by global countries continued to increase. With promising products in the pipeline, HiMedia is poised to reap immense profits in the next fiscal year.   ]]> https://biospectrumindia.com/news/97/4841/covidien-acquires-another-medical-device-company-.html https://biospectrumindia.com/news/97/4841/covidien-acquires-another-medical-device-company-.html Wed, 03 Sep 2014 12:49:18 +0530 Covidien, a global leader in manufacturing medical devices announced that it has acquired Sapheon, a US-based medical device company focused on manufacturing devices for venous disease treatments. Sapheon develops and manufactures the VenaSeal system, which uses a specially formulated medical adhesive to close the great saphenous vein in patients with varicose veins and chronic venous insufficiency (CVI). It is currently approved in Canada, Europe, and Hong Kong. More than 2,000 patients have been treated with the system. The VenaSeal system is a minimally invasive technology, and unlike open surgery and other invasive procedures, patients are often able to quickly restart their regular routine. "Sapheon will significantly enhance Covidien's global peripheral vascular business by providing additional treatment options for physicians and their patients who suffer from CVI. It's technology is complementary to our current portfolio, and this acquisition further demonstrates Covidien's leadership in the CVI space. Our technologies are supported by industry leading clinical evidence, robust global physician training and a superior customer support infrastructure." said Mr Brian Verrier, president, peripheral vascular, Covidien. The company will report the Sapheon business as a part of its peripheral vascular product line in the medical devices segment. The financial details of the deal were not disclosed.   ]]> https://biospectrumindia.com/news/97/5721/a-battery-less-cardiac-pacemaker.html https://biospectrumindia.com/news/97/5721/a-battery-less-cardiac-pacemaker.html Tue, 02 Sep 2014 15:44:00 +0530 Researchers at the University of Bern, Switzerland have developed a new  cardiac pacemaker, which runs without a battery and is modelled on an automatic wristwatch and is powered by heart beats. "Batteries are a limiting factor in today's medical implants. Once they reach a critically low energy level, physicians see themselves being forced to replace a correctly functioning medical device in a surgical intervention. This is an unpleasant scenario which increases costs and the risk of complications for patients. We have come up with a way to power a cardiac pacemaker with an alternative energy source - the heart movement," said Mr Adrian Zurbuchen from the University of Bern, Switzerland. He added, "The heart seems to be a very promising energy source because its contractions are repetitive and are present 24 hours a day, 7 days a week. Furthermore, the automatic clockwork, invented in 1777, has a good reputation as a reliable technology to scavenge energy from motion." The researchers successfully tested the system using in-vivo experiments in domestic pigs. The mechanism allowed them, for the first time, to perform a overdrive-pacing of the device, without a battery, at 130 beats per minute. "We have shown that it is possible to pace the heart using the power of its own motion," he further said. The research was presented at European Society of Cardiology (ESC) Congress in Barcelona.   ]]> https://biospectrumindia.com/news/97/6740/global-nanotechnology-market-to-touch-3-trillion-by-2018.html https://biospectrumindia.com/news/97/6740/global-nanotechnology-market-to-touch-3-trillion-by-2018.html Tue, 02 Sep 2014 13:23:00 +0530 The curtain raiser for the conference was held on September 1, 2014, in Bangalore, in the presence of dignitaries including Prof. CNR Rao, chairman, Karnataka's Vision Group on Nanotechnology; Shri SR Patil, minister for Planning and Statistics, IT, BT, Science & Technology; Shri Srivatsa Krishna, IAS, secretary to the Government, Department of IT, BT and S&T, Government of Karnataka; and Prof. AK Sood, department of physics, IISc. By 2018, the commercial Nanotechnology market is expected to reach $3 trillion, with India having a market chunk of 20-25 percent, revealed Shri Srivatsa. Themed 'Nano Horizons' this year, this international event will serve as one stage confluence for the government, scientists, policy makers, research institutes, students, entrepreneurs, industry and academia, offering a plethora of explorative opportunities in advancing Nanotechnology and Nanotechnology. On the occasion, Prof. CNR Rao said, "In the US, Japan, and China, there is a lot of investment happening in the area of Nanotechnology research. Through this technology, many new materials have come out in the last few years. Actually two years ago, this field didn't exist much. Now it has become a major area of research. There are new developments which are promising, and a number of possibilities are seen in device technology and applications including Spintronics." When asked about Nanobiotechnology fairing in India, he told BioSpectrum, "Nanobiotechnology is doing very well in the country. Major researches has come out of NCBS proving to be very outstanding matching international standards."   Shri Srivatsa emphasized that no part of human life will remain untouched by Nanotechnology and Nanotechnology. "The Ebola virus vaccine is being developed using nano particles. Researchers are turning to Nanotechnology for finding a cure for this dreaded disease," he opined. Prof. AK Sood told BioSpectrum that the new nano park is expected to be unveiled in the next 3 to 4 months. "The initial investment that has gone into this has been about Rs 50-60 crore, and it will add up further phase-by -phase," he told. The top Indian institutions in this area are located in Bangalore - IISc Bangalore being one of them, along with National Center for Biological Sciences (NCBS) and Jawaharlal Nehru Center for Advanced Scientific Research (JNCASR). Talking about Bangalore India Nano, Shri SR Patil said, "In my opinion, this is a historical event. Karnataka is the second largest technology cluster on the planet. In the future, Nanotechnology is expected to have impact on almost every field possible including biotechnology, agriculture, food technology, medicine, healthcare and environment, electronics, renewable energy, IT and material science." India's first premier nano institute is emerging in the outskirts of Bangalore. Under the guidance of Prof. CNR Rao, this institute will be developed into a hub for Nanotechnology in the country. "We are also planning a nano park with an incubation center to promote Nanotechnology industry in the state. In the future, Bangalore will be called as the 'Nano-capital' of India," he added.   Last year, the 6th edition of Bangalore India Nano witnessed more than 600 delegates, with the participation of 245 organizations from 12 countries along with 500 graduate students, and 45 top experts in the industry. This year, the event will include product & technology tradeshow, pre-conference tutorials, keynote talks by eminent guests, poster session, Nano for the Young, Research Industry Collaboration Hub (RICH), and InterlinX, which is a partnering tool and networking reception. The main highlight in this years' edition is the tutorials on nano fabrication, scanning probe microscopy and transnational new medicine. More than 500 participants are expected from 13 to 14 countries to be present at the event. Also, Prof. CNR Rao Bangalore INDIA NANO Science Award and Bangalore INDIA NANO Innovation Award will be presented at the event for distinguished personalities with achievements in Nanotechnology. ]]> https://biospectrumindia.com/news/97/4700/cci-nod-for-wipro-ge-and-ge-india-technology-deal.html https://biospectrumindia.com/news/97/4700/cci-nod-for-wipro-ge-and-ge-india-technology-deal.html Tue, 02 Sep 2014 13:09:01 +0530 Wipro GE Healthcare's plan to acquire GE group's assets related to biotechnology and lifesciences have received a green signal from the Competition Commission of India (CCI). Wipro GE is engaged in manufacturing and distributing various medical equipment and devices while GE India Technology is into multi-disciplinary research and development in varied fields such as biotechnology. As per the deal, Wipro GE will acquire assets of the GE India Technology Center used for research in areas of biotechnology and lifesciences. "The proposed combination would facilitate vertical integration of the businesses of Wipro GE. It would enable it to sell equipment as well as provide related research and other support services in biotech and lifescience areas.  Accordingly, it is observed that there is no horizontal overlap between the businesses of Wipro GE and GE India Technology Center" CCI said in an order. "It is also observed that GE India Technology Center renders 100 percent of its services to the affiliates of GE group across the world, including India," it further said.   CCI believes that the proposed combination will not have any adverse effect on the  competition in India. The companies have approached the CCI for the approval of 'Asset Purchase Agreement' in July.  (Source: The Economic Times) ]]> https://biospectrumindia.com/news/97/4046/tele-medicine-consultations-witness-remarkable-surge-in-2014.html https://biospectrumindia.com/news/97/4046/tele-medicine-consultations-witness-remarkable-surge-in-2014.html Mon, 01 Sep 2014 14:57:51 +0530 Close to 120,402 tele-consultations to rural communities in UP and Bihar has been delivered by the World Health Partners (WHP), a non-profit organization which provides health and reproductive health services in developing countries. With the increase in mobile and technology penetration and on-ground community connect and education initiatives, WHP saw a spike in the requests for tele - consultations in the first half of the current year. The tele consultations ranged between 15,910 and 12,671 in the first half of 2013 and 2012. By the end of June 2014, WHP had conducted 16,464 consultations ranging from ailment reporting, treatment prognosis, diet and life counselling, updates on danger signs of the complicated diseases, Pre and Post treatment care, etc. Consultations with the patients and the health providers also included steps to monitor patients during the treatment and counselling of the families. WHP's network of 5,000 rural health providers were a part of its SkyCare program for tele-consultations involving medical care and follow-ups. Often the first and only point of contact for the majority of patients, these informal rural health practitioners are equipped with low-cost mobile solutions to enable them to provide tele-consultations, referrals, diagnostics, and symptom-based treatments. They are backed by 110 tele-medicine provision centers, called SkyHealth Centers, which in turn are connected to qualified doctors at WHP's Central Medical Facility (CMF) in New Delhi and other nearby towns. The rural health providers are trained by CMF doctors about how to monitor the patients during the treatment and counsel the families. As per Mr Gopi Gopalakrishnan, president and founder, WHP, "Our objective is to harness local market forces to work for the poor by leveraging the latest advances in communication, diagnostics, and medical technology. Combing tele-medicine with the infrastructure and manpower already available in rural areas, we have managed to establish large-scale, cost-effective healthcare networks that provide much-needed health and family planning services in under-served rural areas. Millions of patients have already benefited from our program since it was launched as a pilot project in 2008." With the announcement of the Digital India program at the 2014 budget session, the government has reinforced its support for the ongoing initiatives to bridge the digital divide and ensure broadband connectivity at the village level and improved access to services through IT-enabled platforms, which will strengthen governance and delivery of healthcare services in rural hinterlands. The reduction in duty on components used in manufacture of personal computers will encourage the technology adoption even at the grassroots level, helping in the proliferation of tele-medicine and improved healthcare services till the last mile.   ]]> https://biospectrumindia.com/news/97/4507/robo-brain-a-new-computing-platform-for-robotics.html https://biospectrumindia.com/news/97/4507/robo-brain-a-new-computing-platform-for-robotics.html Sat, 30 Aug 2014 10:05:00 +0530 Two Indian-origin researchers at Cornell University have developed a computational system known as 'Robo Brain.' "Robo Brain is a large-scale computational system that learns from publicly available Internet resources, computer simulations, and real-life robot trials," said lead researcher, Mr Ashutosh Saxena. Explaining its working, he said, "Robo Brain will process images to pick out the objects in them, and by connecting images and video with text, it will learn to recognise objects and how they are used, along with human language and behavior." According to the researchers, the Robo brain accumulates everything related to robotics into a comprehensive and interconnected knowledge base. Applications include prototyping for robotics research, household robots, and self-driving cars. It extracts information available on the Internet with the help of a computational system. It can interpret natural language text, images and videos. "Our laptops and cell phones have access to all the information we want. If a robot encounters a situation it has not seen before, it can query Robo Brain in the cloud," Mr Saxena further said.   The information is being translated and stored in a robot-friendly format that robots will be able to draw on when they need it. The website will display things the brain has learned, and visitors will be able to make additions and corrections.   ]]> https://biospectrumindia.com/features/97/4287/agilent-growth-on-par-with-market-.html https://biospectrumindia.com/features/97/4287/agilent-growth-on-par-with-market-.html Fri, 29 Aug 2014 16:31:00 +0530 Agilent Technologies, a global leader with a total portfolio of mass spectrometry techniques that meet various application needs of the industry, has been rolling out steps to bolster its presence in India. Over a period of time, the company has been registering an average 20 to 25 percent growth every year. However, according to BioSpectrum estimates, in FY 2013-14, Agilent India's lifesciences business stood at Rs 423 crore with a growth of over 15 percent. This can be considered better as compared to an estimated Rs 370 crore in FY-2012-13 when the growth was close to 2 percent, attributed to the slowing down of overall market and also the lack of funds in government and research institutes. The company sources also blame the prevailing macroeconomic conditions due to which customers across markets, especially in pharma, have been very cautious in purchase. The pharma sector continues to be a large contributor to Agilent's Life Sciences and Chemical Analysis (LSCA) business. The Life Sciences Research Center in Bangalore, supports the company globally and develops methods across markets in lifesciences. The setting up of a lifescience application development lab, has helped it accelerate the discovery of analysis workflows. About 60 percent of Agilent India's revenue comes from the LSCA group and 25 percent of the revenue comes from the lifesciences group in India. Overall, Agilent India contributes to 1 percent of the total revenue of Agilent. The company has a strong presence in the food and pharma markets, and in a similar manner would like to expand into other areas of the Indian market, such as environmental and material science. The recent acquisition of Dako, one-of-the-leading global suppliers of cancer diagnostics tools, providing antibodies, reagents, scientific instruments, and software to customers, has helped Agilent accelerate growth in several rapidly-expanding areas of diagnostics, as well as strengthen its existing offerings. Following that, Agilent formed a new business segment, the Diagnostics and the Genomics Group (DGG). The completion of the acquisition of Varian by the company has broadened its applications and solutions offerings in lifesciences. It also expanded Agilent's product portfolio into atomic and molecular spectroscopy; established a leading position in NMR, imaging and vacuum technologies; and strengthens its consumables portfolio. Agilent has introduced many new products including the next generation Agilent 7100 Capillary Electrophoresis (CE) system, which has been claimed to provide at least 10 times more sensitivity than any other commercial CE instrument. Its industry-benchmarked 1200 series HPLC and 7890 GC have been its biggest revenue generators. Agilent's Rapid Resolution LC (RRLC), a fast LC, has been a big success in the pharma segment. It has also launched 6420 triple quadrupole liquid chromatography/ mass spectrometry LC/MS system, a replacement for the 6430 and 6460 systems. Besides that the company recently introduced 6550i Funnel quadrupole time-of-flight chromatography mass spectrometry (Q-TOF LC/MS) system. Agilent has a big market share in pharma. It has also been growing significantly in food testing where it has done exceedingly well in the last two years. In parallel, it has also been reaching out to colleges and universities and focus is on direct channel so that there is quality. The company delivers 100-150 platforms every year. Its percentage of contribution to new clients has been growing. The company has introduced the Microwave Plasma - Atomic Emission (MP-AES) for cost effective elemental analysis capabilities. The technology runs on air instead of argon gas cylinders required generally. It is much environmental friendly.   The operating of CrossLab inaugrated in November, 2013 at Agilent's Manesar facility is expected to further strengthen the company's CrossLab Enterprise Services, a synchronized laboratory solution by Agilent Technologies, a service model for all instruments regardless of the brand. CrossLab will deliver solutions that help improve results, reduce costs, and increase the productivity across the organization. The company is into petro-chemicals, material sciences and agriculture, expecting to do well in these areas. Once the government mines are opened, it expects to do good business from mining too. It is looking at genomics, biosimilars, clinical diagnostics, clinical trials and food sectors as the huge potential areas for its future growth.   ]]> https://biospectrumindia.com/features/97/4424/waters-wins-the-biosupplier-race.html https://biospectrumindia.com/features/97/4424/waters-wins-the-biosupplier-race.html Fri, 29 Aug 2014 12:40:00 +0530 Waters creates business advantages for laboratory-dependent organizations by delivering practical and sustainable scientific innovation to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality. For the FY 2013-14, the company recorded revenue of Rs 564 crore, which is an increase by Rs 60 crore compared to FY 2012-13. Waters division products are used by pharmaceutical, life science, biochemical, industrial, academic and government organizations working in research and development, quality assurance and other laboratory applications. The company's exports account for nearly two-thirds of sales while the company's largest single market is the pharmaceutical industry. The year 2014 marks Waters Corporation's 56th year of analytical instrument industry innovation. While the company offers a broad array of technologies, it still maintains platform products in four key areas: instruments, chemistries, software, and services. Its best known brands are ACQUITY UPLC Systems, ACQUITY UPLC BEH, XBridge, Sunfire, Symmetry, Atlantis, XTerra and Cortecs and columns for analytical - to preparative-scale chromatography and eLab Notebook Software.The biopharma business for Waters India is consistently growing. In India the LC instrumentation business contributed to the major chunk of its business, while mass spectrometry uptake also witnessed a jump in the sales.   Analytical instruments industry faced very challenging market conditions due to combination of many factors, including, but not limited to global and Indian economic conditions, high inflation and depreciation of currency in India. But the future looks brighter, particularly for the pharmaceutical and life sciences market. Pharmaceutical industry has registered close to 15 percent growth so far in this financial year. Due to regulatory, legal and administrative hurdles, the clinical research market has slowed down significantly in the past two years. Progress has been made by issuing robust regulatory guidelines with compensation mechanisms but the sector is expected to emerge once again in the forefront of global scene as the advantages of doing clinical trials in India continues to attract global players. To address the growing need for greater efficiencies and throughput that can be obtained with the automation of routine clinical laboratory assays, Waters and Tecan Group entered into an agreement to combine Tecan's Freedom EVO liquid handling platform with Waters ACQUITY TQD liquid chromatograph/mass spectrometer (LC/MS/MS) to automate sample preparation. The company will combine both the technologies into a single, fully-supported analytical system solution that helps laboratories increase assay throughput and efficiency, improve profitability, and drive down overall assay costs. Waters was awarded the prestigious Pittcon Editors' Gold Award for the new Waters ACQUITY UPC (2) System, as the 'best new product' at Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy. Also, its Waters ACQUITY QDa Detector was named 'Top Innovation for 2013' by The Analytical Scientist magazine.For Waters, biopharmaceuticals in general is a focus area for Waters world-wide and more so in India.Waters launched many products including SYNAPT G2-Si, ACQUITY QDa Detector, ACQUITY UPLC M-Class System and CORTECS 2.7 Micron Columns. There has been some slowing down in the CRO market due to various regulatory issues. Now that such issues are being addressed, Waters expects business to catch up in those sectors. Bio-supplies, clinical, food safety and environmental market is fast growing in India with mega investments planned by the Government of India through Food Safety and Standards Authority of India (FSSAI). Thus, Waters expect a fair share of that opportunity to come in its favor. For Waters, among the markets, its focus will be on life sciences, clinical, food and environment. However in India, its main focus will continue to be in the life sciences market. The company said that it will make additional investments based on the business needs as the economy and business grow in the future. The market is now strongly driven by the increasing health consciousness, rising disposable incomes, increasing number of people being affected by lifestyle diseases, resulting in healthcare spending, and the shifting age structure of the Indian population, like higher median age.   ]]> https://biospectrumindia.com/features/97/3999/introduction-to-digital-health.html https://biospectrumindia.com/features/97/3999/introduction-to-digital-health.html Fri, 29 Aug 2014 10:05:00 +0530       The twentieth century was very typical and traditional. Though newer innovations ranging from penicillin and other drugs, to radio and television occurred within this century, it took a huge lag time for these innovations to penetrate. Especially in a vast country like India, it took further time. The radio took around 2 decades and so did the television. The telephone came in later, but took a good 10 to 15 years to reach households. The late 90s was when the Digital revolution was just initiated in Asia and the biggest thing it brought with it was the speed and pace of changes.    Following the Globalization era in India, the digital revolution was set in the country primarily with the penetration of the PCs earlier and then gathered momentum with the mobile phones, around the first decade of the 21st century. With a population of 1.22 billion people today, India boasts of over 900 million mobile phones in the country - which is the 2nd largest in the world to China, which is 1.20 billion. India and China combined own almost 1/3rd of the world's mobile phones. Asia is also picking up on the number of Internet users with 770 million users only in India and China. Newer sources indicate that India shall cross the 250 million by the end of 2014.   With the increasing usage and penetration of smartphones, the internet usage on PCs is on a decline but on the mobile is increasingly on the rise. Amongst internet users, it is observed that entertainment is the most searched subject, and is, interestingly, followed by health. There are both good sides and bad sides to it. As per the data from DazeInfo, social media usage tops the list as the main internet activity on smart phones. Interestingly, this report also suggests that nearly 16 percent mobile internet users in 35 top cities in India closely follow or use health related applications. What is Digital Health? Simply defined it is using any digital tool, device or technology for augmenting health. According to Wikipedia: Digital health is the convergence of the digital and genetics revolutions with health and healthcare with the goal of reducing inefficiencies in healthcare delivery, improving access, reducing costs, increasing quality, and making medicine more personalized and precise. With the cost of Genetic testing coming down and beginning of the era of personalized medicine, things like tracking Body data, usage of wearable devices and mobility will change the course of things in the not too distant future. With the world getting flatter, well connected and more social, the era of digital health has a very bright future. Let us take the example of the simple eMamta initiative in India. In 2010,the infant mortality rate (IMR) in Gujarat was 48 per 1000 live births. To improve these numbers and reduce the IMR, the Gujarat government implemented the eMamta initiative - a mobile phone based program. Under this program, health workers trained by the National Rural Health Mission (NRHM), collected information on expectant mothers and infants. Based on this info, alerts were used to notify local health workers in each region, who reached out to these mothers to help them understand the plan, and supply them with basic medication as required. The mothers also got sms' about the progress in their term, and this initiative has helped drop the infant mortality rate to 44 per 1000 live births. So initiatives like this, which use an online and offline methodology, can be game changers and are classified under Digital Health. In India specifically, we need to adopt to strategies which would work for us and not blindly copy our western counterparts. Today, people are really mobile with access to GPS, giving their location and also active on social platforms. So the new community arising out is Social, Local, and Mobile called as the SoLoMo. This throws up various opportunities for healthcare, right from collecting Big Data to behavioral targeting health marketers. mHealth or mobile health initiatives will see a big change in the near future in Asia. Both healthcare and technology companies are teaming up with mobile app developers for developing specific health apps. Areas such as weight loss, fitness, conception, exercise and diet tracker, symptom checkers, baby vaccination etc. enjoy a number of downloads from Apple i-store and Google Play. The health start-up sector too is booming, especially in India, with various Venture Capital and Seed Fund companies taking key interest in supporting the sector. Entrepreneurship has been on the rise lately and a lot of newer innovations coming out globally will be from the east in the forthcoming years. Not surprisingly the investment in digital health startups has reached $1.97 billion globally in 2013, which is a 39 percent growth from 2012. In India too, Venture Capital companies are investing heavily in this arena. Some disruptive technologies and early innovations from companies like Biosense, Diabeto etc. showcase a promising future for Indian start-ups. Biosense has launched smartphone based portable diagnostics for checking urine and blood at home, which can also display geographical data for community level surveillance. Their other product ToucHb is a needle free anemia screening tool, which is so very critical with reports predicting anemia to be as high as 75 percent in Indian women. Diabeto - another start-up, is a Diabetes management device, which helps you collect your data wirelessly into your smartphone app and manage your diabetes more effectively. So over a period of time, the app throws up graphs and trends that could be correlated to lifestyle, discussed with Doctors etc, so that one can manage Diabetes better. With a shift to lifestyle diseases, these start-ups have a lot to offer and change the course of health management. In Wearable devices too, while Nike Fuel and Adidas miCoach are a rage, some Indian start-ups too are giving additional value for money. One such product is GOQii-which is dedicated to enabling a permanent shift to a healthier lifestyle. It combines advanced wearable technology with the world's leading experts, coaches and karma. GOQii offers a single integrated solution, which is a powerful combination of technology and human connection. Human-centric design is a critical factor within Digital health. One such example is the service support from i-sure ovulation strips. So while the company sells ovulation strips, they went beyond just the product in supporting a woman who found it difficult to conceive. They realized she could not openly talk, discuss her problems and goes through a lot of stress. Putting up a human-centric design they came up with a set of solutions that went beyond the mere website. They offered a live chat service so the woman could chat or speak anonymously, set sms reminders etc. The mobile app offered a calculation calendar that threw up expected ovulation dates, could set reminders and track the months eventually, and all this anonymously on her own mobile - this app now has about 50,000 downloads. Crowd-sourcing solutions within healthcare, are also increasing. An excellent example is Progeria. Progeria is a rare disease and statistically as of 2009, only 54 children were identified globally. The Progeria Research Foundation (PRF) realized that another 150 children were missing. PRF launched "Find the Other 150" campaign globally for the undiagnosed children with Progeria, so that they too can have access to the unique care they need. In partnership with the GlobalHealthPR group, a worldwide health communications group with offices in the United States, Asia-Pac, Europe and Latin America, using both mass media and digital media, they involved the society to identify these rare children. So from 54 children, today the count has gone to 103 children in 36 countries. Out of the newly identified cases, 3 of them are from India - an excellent example of communications, crowd-sourcing and usage of new media. A recent survey done by MediaMedic in India, showed that 90 percent of the specialty HCPs have adapted to smart phones, and are keen to get newer information real-time in their interest areas. These HCPs enjoy easy connectivity that smartphones offer and professionally too exchange pictures, x-rays, images and reports amongst their peers and patients. Social Media too has caught up and will give a big boost to Digital Health. Searching with specific hashtags such as #diabetes, #cancer, #weightloss, #menopause generates a swarm of local information. Patients are forming their own local support groups on various diseases, so that they can share, empathize and learn from each other's experience. Websites such as Yahoo answers, Sawaal.ibibo, Baby- Center, ehealthforum etc, see a large traffic of patients asking questions and expecting answers from people with similar cases. Topics such as Acne, weight reduction, managing diabetes, conception issues, contraception etc has many seekers and plenty of discussions. The online encyclopedia, Wikipedia, forms an active part of this social media circle and the popularity of this platform to provide information is humongous. Any medicine, its dosage, side effects, indication, contraindication etc can be easily accessed through this medium and consumers at large are exploring it. Newer review platforms for patients to share their experience with the doctor and recommend or suggest the service of this particular doctor will redefine healthcare. Such platforms will go a long way in creating an image or perception of the Doctors based on genuine patient feedback. The user-generated content (UGC) will play an amicable role in shaping up Digital Health. This also calls for a set of guidelines that can help shape up Digital Health constructively. In the near future, a lot of user generated content (UGC) will be up, which will influence consumers, patients and caregiver behavior, and it will be interesting to see the evolution in this space. With the Indian government backing up technology and Universal Healthcare Coverage, it will be an interesting future for the country. The Rashtriya Swasthya Bima Yojana (RSBY) implemented by the government to provide health insurance coverage for Below Poverty Line (BPL) families, is also strongly driven with technology and has now 37 million active smart cards. Also with the ongoing UIDAI project of the Government, whose vision is to empower residents with a unique identity and a digital platform to authenticate anytime, anywhere; it can benefit tremendously when it comes to providing and mapping health. With these changing times, it is very critical for healthcare, pharma and biotech companies to understand the true meaning of 'Digital' and its related applications. Today these companies who have traditionally been the torch-bearer of health, are struggling to realize the full potential 'Digital' has to offer. In fact, technology companies are threatening this sector in adapting and offering digital health products and services. Hence it is important to shed off the 'traditional mindset', have a clear understanding of Digital and embrace it in the correct way. Let us not forget that times are changing at a rapid pace, and we are indeed fortunate to be a part of the generation shaping up 'Digital Health'.   ]]> https://biospectrumindia.com/news/97/5256/ngc-collaborates-with-medtronic-for-expansion.html https://biospectrumindia.com/news/97/5256/ngc-collaborates-with-medtronic-for-expansion.html Thu, 28 Aug 2014 17:41:10 +0530 Under the terms of the agreement, Medtronic has purchased a 30 percent equity stake in NGC, with an agreement to expand NGC's business beyond Italy. Medtronic expects the net impact from this investment to be neutral to fiscal year 2014 earnings and for this transaction to be consistent with the company's disciplined focus on long-term returns. The company also announced the formation of Medtronic Hospital Solutions, a new business focused on developing novel partnerships with hospitals to provide services directly related to hospital operational efficiency. "The creation of this new business within Medtronic underscores our commitment to develop innovative services and solutions that create efficiencies, address costs, and improve patient access and outcomes for a broader set of hospital customers," said Mr Omar Ishrak, Medtronic's chairman and CEO. "We recently announced our acquisition of Cardiocom, which extends our presence and impact in chronic disease management, as part of our expansion beyond devices to healthcare services and solutions. With today's announcement, we have now formed a hospital solutions business aimed at addressing efficiency and operational improvement exclusively focused on delivering better clinical and economic outcomes and value for hospitals," expressed Mr Ishrak. ]]> https://biospectrumindia.com/news/97/4272/medical-device-industry-to-get-new-policies.html https://biospectrumindia.com/news/97/4272/medical-device-industry-to-get-new-policies.html Thu, 28 Aug 2014 17:33:38 +0530 As per reports, the government is planning to consider a separate policy for allowing 100 percent Foreign Direct Investment (FDI) in the manufacture of medical devices, through the automatic route. Currently the industry comes under the Drugs and Cosmetics Act, and the FDI is governed by the same rules that apply to the pharma sector. Though the government allows 100 percent FDI in pharma, it differentiates between setting up a new facility and the expansion of an existing one. FDI for a new facility is allowed through the automatic route but this has to be approved by the foreign investment promotion board and the competition commission of India. "Unlike pharma, FDI in medical devices will be essentially in greenfield (new) projects because there is no question of brownfield (expansion)," an official said. He added, "The government realizes that the medical devices industry has suffered due to a lack of specific norms and policy. Investments in greenfield medical device projects have been impacted because of the clubbing of the industry with pharma. A separate policy will certainly boost investment and generate interest in the sector." A report by the Confederation of Indian Industry (CII) highlights that the Indian medical technology industry has the potential to expand to $50 billion by 2025, if it receives appropriate policy support from the government. It is worth $6.3 billion at present.     ]]> https://biospectrumindia.com/news/97/4518/new-eye-sensor-to-detect-glaucoma.html https://biospectrumindia.com/news/97/4518/new-eye-sensor-to-detect-glaucoma.html Wed, 27 Aug 2014 16:56:39 +0530 Researchers at Ilan University and Stanford University have reported a new eye contact lens that can monitor eye pressure in glaucoma patients. The new lens imbibed with microfluidic sensor can measure fluid pressure inside the eye and provide a readout with a smartphone camera. The simple, low-cost device could make it much easier to diagnose glaucoma. It could also give glaucoma patients a 24-hour home-based monitoring test similar to the glucose monitors available for diabetics. The new sensor consists of an airtight channel that runs around most of the periphery of a lens that is used for cataract surgery. On one side it has a tiny gas reservoir, while on the other it connects to the aqueous eyeball fluid. The lens should  be surgically implanted into a patient's eye. When the microchannel is connected into the eye chamber, pressure drives the intraocular fluid into the microchannel, compressing the reservoir gas until the gas pressure and liquid pressure reach equilibrium. An increase or decrease in the intraocular pressure forces the fluid to move toward or away from the gas reservoir. A smartphone camera equipped with an optical adapter and image analysis software can be used to accurately detect the position of the liquid. The optical adapter positions the camera in front of the pupil and shades the eye, causing the pupil to dilate and reveal the sensor. The optical readout on the new microfluidic sensor is easier to use. The researchers said that their experimental results suggest 10-year device life.   The research is published in the journal Nature Medicine.   ]]> https://biospectrumindia.com/news/97/4236/medtronic-acquires-sapiens-for-200-million.html https://biospectrumindia.com/news/97/4236/medtronic-acquires-sapiens-for-200-million.html Wed, 27 Aug 2014 16:53:00 +0530 The acquisition of Sapiens SBS strengthens Medtronic's capabilities in an important, emerging frontier of medicine - the modulation of brain function. "This acquisition broadens our neuroscience leadership position with innovative brain modulation technology that, along with our comprehensive portfolio of DBS solutions, may one day transform the way physicians are able to treat patients with neurodegenerative diseases like Parkinson's disease and essential tremor," said Dr Lothar Krinke, vice president and general manager, Brain Modulation business, Medtronic. Sapiens, located in Eindhoven, is developing a DBS system that features an advanced DBS lead with 40 individual stimulation points. This advanced system is designed to allow more precise stimulation of the intended target in the brain and may potentially result in reduced procedure time and fewer stimulation-induced side effects. Medtronic's press statement said that employees at the Eindhoven facility will continue to work toward bringing this technology to market. In the future, the site will serve as a global R&D center for Medtronic's Neuromodulation business, complementing its existing R&D operations.   Medtronic and Sapiens SBS will work to finalize product development and begin clinical research to integrate these technologies into an expanded portfolio of DBS products within Medtronic's Neuromodulation business. Mr Jan Keltjens, CEO, Sapiens SBS commented, "We are excited to join Medtronic, and look forward to collectively working to bring this and other novel technologies and therapies to neuromodulation patients worldwide that could benefit from them." The transaction is expected to meet Medtronic's long-term financial metrics and does not impact fiscal year 2015 earnings guidance, said the company's statement. ]]> https://biospectrumindia.com/news/97/5954/no-confirmed-cases-of-ebola-in-india-who-director.html https://biospectrumindia.com/news/97/5954/no-confirmed-cases-of-ebola-in-india-who-director.html Tue, 26 Aug 2014 14:56:00 +0530 "Despite rumors," said Dr Poonam Singh, "there have been no confirmed cases of Ebola in the eleven countries of WHO's South-East Asia Region, including India." According to Dr Singh, an Ebola Response Roadmap has been developed by WHO with accelerated and focused activities for the next 6 to 9 months. The estimated financial requirement for the implementation of this roadmap is around $430 million, she revealed. The following are the objectives of the roadmap: Full geographic coverage with Ebola response activities in countries with widespread transmission Ensuring emergency application of Ebola response interventions in newly affected countries Strengthening global preparedness "This is the time to step-up preparedness. A successful public health response will need strong health systems with sensitive surveillance, infection control and community mobilization," Dr Singh opined.   WHO has been working closely with national authorities in West Africa and leading the international response. Dr Margaret Chan, director general, WHO, visited West Africa and held discussions with heads of governments. More than 400 experts and WHO staff from all over the world have been mobilized to the epicenter of the event in West Africa to assist efforts of national authorities. "We are sharing information on the evolution of the event with all member States along with technical guidelines on all aspects of the disease. Through WHO's accredited laboratories network, and support to shipment of infectious material to these labs, it is assisting countries in establishing a diagnosis of suspected cases," Dr Singh said. Currently there are 45,000 Indians living in the Ebola-affected West African countries. According to a latest report, 6 people who had arrived at Delhi airport this morning from Ebola-hit Liberia have already been quarantined and taken out for various laboratory tests. A NDTV report said that today around 112 passengers are expected to arrive in Delhi and Mumbai airports from the affected regions. ]]> https://biospectrumindia.com/news/97/4039/philips-gets-fda-nod-for-its-tavi-treatment-planning-application.html https://biospectrumindia.com/news/97/4039/philips-gets-fda-nod-for-its-tavi-treatment-planning-application.html Tue, 26 Aug 2014 13:02:59 +0530 Philips has announced that it has received the 510(k) clearance from the US Food and Drug Administration (US FDA) to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatment. Through 3D imaging, TAVI provides interventionalists with pre-procedural, high-precision positioning to treat aortic stenosis ailments. The Philips TAVI planning application is available as a part of Philips IntelliSpace Portal 6-the company's advanced visualization and analysis solution that allows clinicians to access and analyse patient imaging and data virtually anywhere, at any time. The application features a comprehensive measurement package to accommodate, virtually, all types of TAVI devices. "As our population ages, minimally invasive TAVI procedures are becoming increasingly popular in the United States since they provide a non-surgical option for those patients who might have once been considered too high-risk for heart surgery," said Mr Gene Saragnese, CEO, Imaging Systems, Philips Healthcare. He added, "Treating cardiac conditions requires immense precision and our TAVI planning application delivers a solution for aortic device placement to help improve patient care." The application will be displayed at the upcoming ESC Congress 2014 where attendees can experience the Philips cardiology solutions first-hand, with a focus on the continuum of care, from prevention and diagnosis, to treatment, recovery, and wellness, delivering more efficient and effective cardiovascular care in the treatment of Coronary Artery Disease (CAD), Structural Heart Disease (SHD), and Heart Failure (HF).   ]]> https://biospectrumindia.com/news/97/4198/cochlear-implantation-a-boon-for-the-deaf.html https://biospectrumindia.com/news/97/4198/cochlear-implantation-a-boon-for-the-deaf.html Tue, 26 Aug 2014 12:55:00 +0530 Held at Mumbai-based Jaslok hospital, Dr Sandra Desa Souza convened organized an international symposium on Cochlear implantation, wherein many eminent doctors working in the field delivered lectures. The main highlight of the event was the live surgical demonstration of Cochlear implantation. Deaf children and adults who cannot be benefitted from hearing aids were provided with the implants at the symposium. A Cochlear implant is an electronic device, the internal component of which is implanted during the surgery while the external component is later worn on the body as the speech processor. With the implant, children who are born deaf can hear and be taught to speak, while patients who became deaf after acquiring speech are given hearing and can continue living normally. At the two-day event, a series of lectures were delivered by eminent doctors on various topics in the field of Cochlear implantation. To back up the series, the hospital had organized a live surgical demonstration by Dr Jacques Magnan, showing an exposed facial nerve, facial rescess on the second day of the event. The patient operated on, was Mr Om Deokate, with a posterior tympanotomy and cochleostomy to introduce the device. Dr Dillon D'souza operated on a patient, Ms Riddhi Bagadkar using the Inverted Veria technique and Cochleostomy without exposing the facial nerve and Dr JM Hans operated on Mr Jafin Sheikh using a minimally invasive Veria technique. Dr Sandra Desa Souza arranged for the funds for the implants, the surgical and hospitalization costs. All the patients are doing well after the surgery. Dr Sandra Desa Souza, director, ENT Jaslok Hospital and ENT Consultant at Breach Candy and Desa's Hospital, was the first woman surgeon in the world to pioneer the Cochlear implant surgery in India and Asia in 1987. The program ended with a valedictory function and certificates were distributed to the delegates. ]]> https://biospectrumindia.com/news/97/7250/bosch-expands-into-healthcare-in-india.html https://biospectrumindia.com/news/97/7250/bosch-expands-into-healthcare-in-india.html Tue, 26 Aug 2014 12:50:13 +0530 "We have been making concerted efforts to further strengthen our non-automotive business in the Indian market. The launch of the eye screening and detection system is a step in this direction.... Our foray into this area aims to promote better ophthalmological care for all Indians," said Dr Steffen Berns, president, Bosch Group India, at the product launch. The new eye screening and detection system offers a combination of hardware and software, and provides affordable eye care. According to global health statistics, nearly one of every three visually impaired people in the world is an Indian. The compact hand-held fundus camera is designed to respond to the shortage of eye-care specialists and the high demand for vision screening in the country. The newly-launched solution also reflects Bosch's approach to solving local problems by leveraging global capabilities. Robert Bosch Engineering and Business Solutions Limited, Bosch's largest software development centre outside Germany, started the product development almost two years ago in collaboration with various startups and universities. Offering early detection and imaging without dilation, the new system can capture both the front and back of the eye, and a light weight for easy portability. Its software is cloud- and smartphone-compatible and caters to the needs of both specialists and technicians.  The device has been tested by several eye-care providers. Thus far, Bosch India has filed five patents in this field and is planning to further develop the technology in this line of business in the upcoming years. "We believe that Bosch's eye screening and detection system will bring global standards of eye care to India. It has been conceptualized and developed in India with state-of-the-art technology from across the world," Dr Berns added. According to eye-care experts, 80 percent of cases of vision loss in India are preventable. Bosch's eye screening and detection system meets the demand for comprehensive eye care of the middle- and lower-income demographic and offers high functionality, ease of use, and a cost effective system to doctors. The new eye screening and detection system is now available to an array of customers, ranging from ophthalmologists, to optical chains and from government primary healthcare centers to non-governmental institutions involved in vision care. Offering early detection and imaging without dilation, the system has a modular architecture for capturing both the front and back of the eye, and a light weight for easy portability. Its software is cloud- and smartphone-compatible and thus appropriate for Indian settings, and caters to the needs of both specialists and technicians. The hardware and software combination represents a first for the Indian market and can be augmented with automated detection algorithms for different eye conditions, said Bosch's press statement. ]]> https://biospectrumindia.com/news/97/5426/covidien-acquires-reverse-medical-corporation.html https://biospectrumindia.com/news/97/5426/covidien-acquires-reverse-medical-corporation.html Mon, 25 Aug 2014 18:02:21 +0530 Covidien, a medical device manufacturing company announced that it has acquired Reverse Medical Corporation, a privately held California-based medical device company focused on expanding the management of vascular diseases. "Covidien is focused on technologies that deliver improved patient care through clinically relevant and economically valuable solutions," said Mr Brett Wall, President-Neurovascular, Covidien. He added, "The acquisition of Reverse Medical is complementary to our existing portfolio and will allow us to leverage existing vascular technologies to compete in the worldwide vascular embolisation market, which is growing at a double digit rate." Covidien will report the reverse medical business as part of its neurovascular product line in the medical devices segment. Reverse Medical is currently commercialising its vascular embolisation plugs, MVP Micro Vascular Plug System and UNO Neurovascular Embolization System. MVP and UNO are self-expanding vessel occlusion devices, which close blood vessels for vascular embolisation. A number of clinical applications require occlusion of the vasculature to rapidly, effectively and safely provide blood flow cessation. The financial details of the deal were not disclosed.   ]]> https://biospectrumindia.com/news/97/5425/standard-regulations-for-the-medical-device-industry-aimed.html https://biospectrumindia.com/news/97/5425/standard-regulations-for-the-medical-device-industry-aimed.html Mon, 25 Aug 2014 17:26:59 +0530 The majority of India's medical devices are imported due to low customs duty, which is hindering the growth of the local device manufacturers believes Association of Indian Medical Device Industry (AIMED). They have, hence, seeked out proper regulations to monitor the medical device industry. Mr Rajiv Nath, secretary, AIMED, said, "Many Indian manufacturers have made a strategic shift and are now increasingly resorting to imports and trading rather than investing in factories and domestic production. Earlier, the level of domestic production in the overall medical devices industry was around 60 percent. However, at the moment, more than 70 percent is imported. We have become traders in place of manufacturers." The AIMED is rooting for developing proper regulations to monitor the industry, so that the local made medical devices could also compete with the imported ones, owing to a standard certification. In its letter to the Ministry of Health (MoH), it has said that there is an urgent need to create a regulatory framework for medical devices and incorporate the best practices as per international standards. The letter suggested, "An ordinance may be passed to remove medical devices from the definition of drugs in the Drugs and Cosmetics Act. This would pave way for passing a bill on regulation of medical devices and patient safety by a national regulatory authority under the MoH. The current Central Drugs Standard Control Organisation's (CDSCO) role could be enlarged with more autonomy and could be renamed as the Indian Healthcare Products Regulatory Authority with de-centralized divisions for drugs, cosmetics, medical devices, and diagnostics." The Indian medical device industry has the potential to grow to a $50 billion industry as indicated by the Confederation of Indian Industry (CII) report from the current $6.3 billion at present, if it receives proper support from the government.       ]]> https://biospectrumindia.com/news/97/4053/supreme-court-defers-hearing-on-clinical-trials.html https://biospectrumindia.com/news/97/4053/supreme-court-defers-hearing-on-clinical-trials.html Mon, 25 Aug 2014 14:52:26 +0530 Ongoing hearing of public interest litigation (PIL) filed by an NGO, Swasthya Adhikar Manch, that was supposed to come up for hearing today on August 25, 2014, has now been postponed for future date. The SC bench asked for few more days to go into the details presented by rival sides, before it hears the further arguments in this regard. Earlier in April, 2014, the bench led by Justice Lodha had ruled for an additional triple-test for all global clinical trials and especially for cases involving new chemical entities. It had directed the government to ensure that three parameters - "assessment of risk versus benefit to the patients, innovation vis-a-vis existing therapeutic option and unmet medical need in the country" - are followed before approval for any global clinical trial. "To obviate any controversy in future in this regard, we direct that henceforth in the format seeking information from the applicants, three specific columns regarding the above parameters shall be inserted for the purpose of New Clinical Entities/Global Clinical Trials," it observed. ]]> https://biospectrumindia.com/news/97/5423/is-guinea-pig-theory-an-overhyped-myth.html https://biospectrumindia.com/news/97/5423/is-guinea-pig-theory-an-overhyped-myth.html Sun, 24 Aug 2014 17:43:00 +0530 Ms Radhika (name changed), a patient who has been a part of the clinical trials being done on a drug that could treat her, is happy about the opportunity. Although she doesn't hide the fact that she did have apprehensions about the trials in the beginning, but her experiences she says, have been satisfactory. "My participation in the clinical trials helped me get health reports constantly. I was cared for and there were no issues at all. At least I got an opportunity to get a treatment than nothing at all," shared the patient on the basis of anonymity. The patient who was well-educated also laid stress on the need for more volunteers for the trials as it is the only way to test the drugs for disease for which there is no treatment. "Somebody has to come forward to take up the challenge, inspite of the fact that there could be adverse reactions. Otherwise how will new drugs come?" asked the patient. Echoing her sentiments, Dr Shamsher Dwivedee, senior consultant neurologist, Fortis Memorial Research Institute, mentioned, "Those who are criticizing the trials don't understand the suffering of the people and forget that it is a human issue. I have a case where a patient was willing to even travel abroad for trials because there were no such opportunities in India." The social activists who have been critical of the trials term these as tools of multi-national companies to exploit unwilling, unsuspecting patients. Their concerns on deaths, compensation, and willingness to undergo trials etc., have already been taken care of by the regulator. But there is still a mysterious hatred for the trials and as a result there are ongoing cases pending in various courts including the Supreme Court.   Irrespective of genuine concerns that need to be looked into, it is important to realize that there are no means to develop drugs unless tested on the human body. Former member of parliament and CEO, Max Neeman International, Dr Ajoy Kumar, feels that India will be a great loser if it fails to overcome these hurdles at the right time. He said, "Our contribution to trials is merely one percent. So this whole guinea pig argument is ridiculous and that if we would not be part of the global efforts to develop drugs, it amounts to locking ourselves up in the 21st century." Dr Kumar added further, "We have to realize that India is not the center of the world in development. Trials are the tail end of the developmental process, which is part of basic science. Emotional responses to an issue that is scientific in nature are misleading." ]]> https://biospectrumindia.com/news/97/5486/now-headphones-that-measure-heart-rate.html https://biospectrumindia.com/news/97/5486/now-headphones-that-measure-heart-rate.html Sat, 23 Aug 2014 15:32:00 +0530 Intel is all set to challenge Samsung and Apple in developing cool wearable health devices. Reportedly, the company has partnered with SMS Audio, a global headphone and accessories brand, to create a new category of wearables or smart headphones with sensors that can measure the heart rate. "Intel is focused on driving innovation in the wearable technology segment by partnering with lifestyle brands like SMS Audio that complement our technology and design expertise," said Mr Michael Bell, corporate vice president and general manager of the New Devices Group at Intel. He added, "With SMS Audio, we will bring smart headphones to the market. These eliminate the inconvenience of add-on devices with an integrated, one-device fitness accessory offering high-end style and premier sound quality for an exceptional fitness experience. This is a prime example of Intel driving innovation in wearable devices while being a fore-runner in merging lifestyle and technology." "The wearable technology collaboration between SMS Audio and Intel elevates our capability to bring smart exercise to consumers," said Mr Brian Nohe, president, SMS Audio. "With the introduction of the SMS Audio BioSport In-Ear Headphones powered by Intel, we're now the first to provide this level of integrated, seamless and helpful biometric information to inspire customers to advance their fitness experience," he added. The companies said that the headphones will deliver high-end audio quality. They will integrate biometric sensors in a custom heart-rate monitor. They also mentioned about having patented an ear-hook design that makes the headphones comfortable. The device has a built-in optical sensor which continuously measures heart rate during intense exercise, states of relaxation and every moment in between, while dynamically removing noise signals caused by body motion and ambient light. It will be sweat and water-resistant, and will synchronize with the RunKeeper step-tracking app.   It will come with a tangle-free cord, an in-line microphone, neoprene carrying case, and three sizes of ear gels and hooks. It is slated to hit the market later this year.   ]]> https://biospectrumindia.com/news/97/5475/big-data-analysis-to-study-parkinsons-disease.html https://biospectrumindia.com/news/97/5475/big-data-analysis-to-study-parkinsons-disease.html Sat, 23 Aug 2014 10:10:00 +0530 Chip giant Intel has partnered with Michael J Fox Foundation for Parkinson's Research and is working on a study that will pull patterns from data collected from patients' wearable devices. The collaboration, which Intel announced recently, will give the software giant the opportunity to show off the power of Intel-powered data center infrastructure in the Amazon Web Services public cloud, as well as the Cloudera distribution of the Hadoop open-source software for analyzing lots of different kinds of data. "The health-care industry is where we truly believe the biggest opportunity lies when it comes to big data analytics," said Mr Diane Bryant, senior vice president, Intel data center group. The data taken from smart watches can detect walking, tremors, and other activities in patients. Data scientists can then consider the perspectives of Parkinson's experts to develop algorithms that can look for trends and anomalies. A study that began this year involved 16 Parkinson's patients and nine control volunteers who wore wearables, according to a statement. Data scientists at Intel are exploring the data now.   Mount Sinai Hospital in New York and the Tel Aviv Sourasky Medical Center in Israel are participating in the effort, Mr Bryant mentioned.   ]]> https://biospectrumindia.com/news/97/5393/bms-pfizer-to-present-clinical-trials-data-on-eliquis.html https://biospectrumindia.com/news/97/5393/bms-pfizer-to-present-clinical-trials-data-on-eliquis.html Fri, 22 Aug 2014 10:31:48 +0530 The new clinical trial data and New Global Health Economics and Outcomes Research (GHEOR) analyses assessing cost effectiveness and real-world use to reinforce the alliance's commitment to the ongoing analysis of Eliquis in both the nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). BMS in a statement also said that 14 abstracts will be presented, including new analysis from the ARISTOTLE, AMPLIFY and AMPLIFY-EXT trials evaluating patients with NVAF and VTE. ]]> https://biospectrumindia.com/news/97/5283/biotech-cos-hesitant-to-invest-in-rare-disorders-rd.html https://biospectrumindia.com/news/97/5283/biotech-cos-hesitant-to-invest-in-rare-disorders-rd.html Thu, 21 Aug 2014 10:23:03 +0530 "We have the talent and the money, however, it is not coordinated into actual deliverables. We have the largest biotech companies here. Many are interested in investing in rare disorders R&D. But the moment they think in terms of marketing and business, that is where the hesitancy is," she commented. Many biotech and pharma companies seem to invest millions in cancer research. "Rare diseases affect patients throughout their lives. Treating rare diseases is life-long. That's where we can see potential business opportunities," she said. "Treated children suffering from rare diseases can live a normal life like everyone else. They are not mentally retarded. But they do have some physical disabilities," she opined. Enzyme replacement therapy or ERT is critical to improve the quality of life for patients suffering from rare genetic disorders. "Without treatment, there is progressive accumulation of partially degraded compounds which stealthily leads to multiorgan dysfunction," Dr Bhat revealed. The government of Karnataka made a historic decision to include treatment of rare diseases children in Karnataka, and made a budgetary provision in 2014-15 to set up a special unit at Indira Gandhi Institute of Child Health. "Treatment for LSD is beyond the reach for most patients. Government support in terms of funding is imperative to help them lead a normal life. We urge the Karnataka government to release funds already allocated in the state budget for the treatment of rare diseases without any further delay so that patients get timely treatment," said Mr Manjit Singh, president, Lysosomal Storage Disorder Support Society (LSDSS). ]]> https://biospectrumindia.com/news/97/5318/cpc-launches-new-line-of-aseptiquik-stc-connectors-.html https://biospectrumindia.com/news/97/5318/cpc-launches-new-line-of-aseptiquik-stc-connectors-.html Thu, 21 Aug 2014 10:18:53 +0530 Colder products, a leading player in connecting solutions, has announced the launch of its combination product, AseptiQuik STC connector. The product allows biopharma manufacturers to improve processes by lowering manufacturing costs, flexibility in design and plant configuration. The hybrid of two connectors via a sanitary clamp, allows a sterile connection for a steamed-in-place (SIP) on a stainless steel equipment. A wide range of single use systems can be connected to the AseptiQuik sterile connector and Steam-Thru II SIP connector, offering Indian manufacturers with greater flexibility for hybrid stainless steel and single-use processing. "This new product is the direct result of customer inquiries on how to SIP an AseptiQuik connector to stainless process equipment," said Mr Ernest Chan, director of sales, Asia Pacific, CPC. He added, "This functionality allows Indian drug manufacturers that employ both traditional and single-use bioreactors to utilize common bag systems and tubing manifolds, reducing SKUs and overall cost."The AseptiQuik STC connectors are offered in both a standard version for gamma sterilization and a high temperature (HT) version for autoclave sterilization.   ]]> https://biospectrumindia.com/news/97/5677/patients-back-out-from-clinical-trials-fearing-av-consent.html https://biospectrumindia.com/news/97/5677/patients-back-out-from-clinical-trials-fearing-av-consent.html Thu, 21 Aug 2014 10:16:18 +0530 The discussion was led by Ms Suneela Thatte, president, ISCR, and Dr Bapsy, senior consultant and head of department, oncology, Apollo Hospitals. During the discussion, Dr Bapsy revealed that Japan leads in clinical trials followed by China, Taiwan and Korea. "The population of Korea is not more than Karnataka, but they are engaged in more trials than India," she said. Talking about AV consent of patients during clinical trials, Dr Bapsy added, "In one way the audio-video (AV) consent is appreciative. However, many patients do not want to sit before a video camera. They are extremely conservative. Women are especially reluctant, and they hesitate to participate if it requires an AV consent." Also, the AV consent is said to add heavily to the clinical research costs. "With our infrastructure the AV consent is not suitable. Later, when we advance, our hospitals will be able to afford it. Many patients are fleeing clinical trials not because of the harm that maybe caused by the drug but due to the AV consent," she emphasized. Currently, only in the case of difficult surgeries or transplantations, corporate hospitals execute AV consent of patients and their families as they are a one-time crucial activity.   "Taking the portrait pictures of patients will involve a third person who are professional photographers which brings the issue of confidentiality, since doctors and researchers are not qualified in taking pictures. This is not possible in government hospitals," Dr Bapsy opined. At this point, the onus is expected to be with the ethical committee who can be the best decision makers. "Clinical research should be done with proper regulatory and trained investigators together with an efficient committee. If these three are in place, then there is definitely no harm caused to the patients," she concluded. ]]> https://biospectrumindia.com/news/97/5269/ge-launches-a-pocket-size-ultrasound-device-.html https://biospectrumindia.com/news/97/5269/ge-launches-a-pocket-size-ultrasound-device-.html Wed, 20 Aug 2014 16:28:32 +0530 GE Healthcare has launched Vscan with Dual Probe to give healthcare providers more uses for pocket ultrasound. The device houses two transducers in a single probe, allowing clinicians to see both shallow and deep views of the body without changing probes. This enables efficient triage and fast workflow, which may lead to time and cost savings in many point of care settings. Vscan is a handheld, pocket-sized visualization tool powered by ultrasound technology that enables physicians to visually inspect inside of patient's body during a physical exam. For emergency care, this includes inserting central or peripheral lines (IV line inserted into a large vein) or completing focused heart and lung assessment exams. For hospital environments this includes bedside cardiac evaluations on rounds and efficient assessment at admission and discharge. "We're excited to unveil Vscan with Dual Probe-a first-in-market dual probe ultrasound device," said Mr Ajay Parkhe, GM, Primary Care Ultrasound for GE Healthcare. "It builds on our experience in the global pocket ultrasound market to solve our customers' biggest clinical and economic challenges. With this latest edition to the Vscan family, our pocket-sized ultrasound technology provides both deep and shallow scans to help healthcare providers make confident decisions quickly, impacting both cost and time. Just like the current Vscan, this new device is ultra-portable very easy to use, has excellent image quality and allows the clinician to take a quick look, non-invasively, inside the patient. In addition, the Dual Probe version combines the sector probe with a linear probe in one device to conduct most of the standard ultrasound scans within minutes."   Additionally, for obstetric areas, this includes visualization of fetal heartbeats, and quick assessment of fetal position or maternal status. Vscan with Dual Probe puts ultrasound capabilities in clinicians' pockets to give them convenient access-when and where they need it most. "The past 5 years have demonstrated that miniaturized, portable ultrasound technology like Vscan can have a tremendous impact on the practice of healthcare in developing and developed nations," said Mr Anders Wold, president and CEO of GE Ultrasound. "We hope with our new Vscan with Dual Probe we have made the use of ultrasound at the point of care, simple and fast all the while helping healthcare providers improve access to impactful medical technology."   ]]> https://biospectrumindia.com/news/97/5280/glenmark-develops-a-novel-antibody.html https://biospectrumindia.com/news/97/5280/glenmark-develops-a-novel-antibody.html Wed, 20 Aug 2014 16:14:57 +0530 The company enters oncology with the discovery and the initiation of IND enabling studies of this innovative bispecific antibody GBR 1302. This is the first bispecific antibody based on Glenmark's proprietary BEAT platform, said the company's press statement. The antibody was discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland. Commenting on this milestone, Dr Michael Buschle, CSO and president - Biologics, Glenmark Pharmaceuticals said, "GBR 1302 is significant for Glenmark on multiple levels. It is our first bispecific antibody. It is our first antibody based on our proprietary BEAT antibody engineering platform and it represents the entry of Glenmark into the oncology innovator space, which has a huge commercial potential." The discovery is based on Glenmark's innovative BEAT antibody technology platform which facilitates the efficient development and manufacture of antibodies with dual specificities termed, bispecific antibodies.   This is said to be the first clinical development candidate based on the BEAT technology. Glenmark expects to obtain approval for the initiation of clinical studies during this financial year. HER2, also known as HER2/neu, or receptor tyrosine-protein kinase erbB-2, is the target of the antibody cancer drugs Trastuzumab, Pertuzumab and Trastuzumab Emtansine and is involved in breast cancer and ovarian cancer. GBR 1302's mode of action is different from current HER2 targeting antibodies. It redirects cytotoxic T-cells through its CD3 binding arm onto HER2 expressing cancer cells and induces the killing of the cancer cells. The killing of cancer cells by GBR 1302 is more rapid, more complete and not subject to the same resistance escape mechanisms as competing therapies claimed Glenmark's press release. With the invention of the BEAT technology Glenmark's scientists have now overcome these bottlenecks and GBR 1302 is the first drug candidate based on this antibody engineering breakthrough technology. ]]> https://biospectrumindia.com/news/97/5274/government-to-launch-an-e-healthcare-service.html https://biospectrumindia.com/news/97/5274/government-to-launch-an-e-healthcare-service.html Wed, 20 Aug 2014 15:25:57 +0530 The ministry of health and family welfare will start an e-healthcare service that will strengthen health awareness in rural India, an official said. "The ministry of health and family welfare has already prepared the white paper for the e-healthcare service. This will raise awareness among the people in the country, who remain completely deprived of health services initiated by the government," Mr Jagdish Prasad, director general, health services, ministry of health and family welfare said. The e-healthcare system will be a web portal which will help the government enlighten people about all the health-related programs and various other schemes that enable them to get free medical treatments. Speaking about the importance of health awareness, he said, "The situation today is such that, due to a lack of health awareness in the rural parts of the country, 70 percent of rural women do not know the essentials of breast feeding, due to which their children suffer from several health issues and hardly get any medical care." He also mentioned the government's plan to improve the country's health sector, "To improve healthcare in the coming years, the Indian government will convert district hospitals into medical colleges and upgrade medical colleges into better health institutions."   ]]> https://biospectrumindia.com/news/97/5288/indias-contribution-a-mere-2-in-clinical-research.html https://biospectrumindia.com/news/97/5288/indias-contribution-a-mere-2-in-clinical-research.html Wed, 20 Aug 2014 13:28:00 +0530 Despite being home to one sixth of the world's population and carrying one fifth of the world's disease burden, yet less than 2 percent of global clinical research takes place in India. This is bad news for patients suffering from critical diseases. The reasons for the decrease include issues such as regulatory hassels, anti-trial activists, compensation issues, patient deaths etc. Ms Suneela Thatte, president, Indian Society for Clinical Research (ISCR) said "The quest for finding superior and lifesaving medicines is an ongoing one. For every medicine and device that gets a marketing approval, there is a larger story of years of research in laboratories and extensive patient participation in clinical trials to determine their safety and efficacy." She further added, "Patients help patients. Today all of us have access to better and newer treatments because of patients who have participated in clinical trials. Thus, we are all beneficiaries of clinical research. Yet it is unfortunate that the progress of clinical research in India has been stalled by several extraneous factors denying patients the opportunity to participate in and benefit from ongoing clinical research. The impact of this on patients is huge. A slowdown in clinical research in the country means little or no access to newer and better medicines for our patients and a rising disease burden." "Due to the existing tumultuous clinical trials milieu in the country, new drug development is totally hampered. We have a huge rise in the number of NCDs including depression, hypertension, and cancer, and soon we will be the diabetes capital of the world. At the same time, there are diseases which are reflective of a developing economy like TB, malaria, and leprosy among others. Unfortunately, we do not have satisfactory treatments for these diseases. Also, we have HIV, and recently the Ebola, for which there is no cure at present," emphasized Ms Thatte. "If we do not forge into clinical research and drug development, soon we will face issues for which we will not have satisfactory access to medicines," she added. The current uncertainty in clinical trials in India discourages Indian companies from performing clinical research and drug development.   "Clinical trials are crucial to attack the diseases bothering our country. No companies from the West are going to think about TB, which is a major issue here in our own country," she justified. Ms Thatte also opined that it is important to have a balanced regulatory environment. "It is important to take care of the interests of patients participating in clinical research, and never compromise on their safety," she said. During the discussion, she also pointed out that negative publicity and existing uncertain regulatory environment have affected Indian pharma companies including multinationals. "Many MNCs are going away from India, proving it to be an unfavorable destination for clinical trials. Sadly, Indian companies too, involved in drug development are pulling out of the country," she lamented. It is not just the clinical research industry, but also academic research that bears the brunt. "Cutting-edge technologies have come out of academic research as well, especially in the area of cancer. Its contribution has been exceptional, ensuring the availability of attractive treatments," she said.   Ms Thatte holds the opinion that a clinical trial environment should support innovation. "Without innovation there will be no progress and our disease burden is not going to be addressed," she stated. She concluded by saying that it is imperative to create awareness on the regulatory environment, which protects the interests of the subjects and patients taking part in clinical research. "At the same time, the clinical research environment should also be balanced. Regulations should always be stringent and never relaxed. Otherwise, the clinical data collected after spending millions of dollars in the country will be rendered useless," concluded Ms Suneela Thatte. ]]> https://biospectrumindia.com/news/97/5122/indian-medtech-industry-to-touch-50-billion-report.html https://biospectrumindia.com/news/97/5122/indian-medtech-industry-to-touch-50-billion-report.html Mon, 18 Aug 2014 14:41:03 +0530 A report by the Confederation of Indian Industry (CII) highlighted that Indian medical technology industry has the potential to expand to $50 billion by 2025, if it receives appropriate policy support from the government. It is worth $6.3 billion at present. The medical technology sector covers medical devices, equipment and diagnostics that are used as part of healthcare services rendered to a patient. "To develop a clear roadmap for making India a global hub for the medical technology sector, we have prepared a vision document in partnership with the Boston Consulting Group (BCG)," said Mr Pavan Choudary, chairman of the Medical Technology Division of CII and managing director, Vygon India. The vision document, entitled 'Revitalising Manufacturing and Innovation to realise the $50 billion Potential', will be released at the 7th Medical Technology Conference being organised by CII Medical Technology Division later this month.   ]]> https://biospectrumindia.com/news/97/5065/pfizer-inks-pact-to-study-ibd.html https://biospectrumindia.com/news/97/5065/pfizer-inks-pact-to-study-ibd.html Sun, 17 Aug 2014 16:55:00 +0530 Pharmaceutical giant Pfizer has joined hands with genetics-testing startup 23andMe, to study the genetics of inflammatory bowel disease (IBD), or the chronic inflammation of the digestive tract. Reportedly, the study is looking to genotype 10,000 volunteers in the United States who have been diagnosed with Crohn's disease or ulcerative colitis, the two types of IBDs. While the participants cannot be 23andMe customers, they will submit samples through 23andMe's at-home saliva collection kit and fill out online surveys through the company's website. The goal is to develop new or improved treatments, the companies said. "Pfizer is committed to bringing forward new treatments for people suffering with IBD", said Mr Jose Carlos Gutierrez-Ramos, senior vice president and head of biotherapeutics, research and development, Pfizer in a statement. He added,"By enhancing our understanding of the underlying biology of the disease, we hope to better support our clinical research activities and development programs." 23andMe CEO Ms Anne Wojcicki mentioned in a statement, "We are excited about teaming up with Pfizer to take an innovative, consumer-centered approach to try to understand the fundamentals of inflammatory bowel disease and the variability of treatment response."       ]]> https://biospectrumindia.com/news/97/5012/astrazenecas-gout-drug-completes-phase-iii-trials.html https://biospectrumindia.com/news/97/5012/astrazenecas-gout-drug-completes-phase-iii-trials.html Sat, 16 Aug 2014 14:51:00 +0530 AstraZeneca's drug candidate Lesinurd has successfully finished Phase III trials, as per reports. Three Phase III studies looked at the drug, a selective uric acid (sUA) re-absorption inhibitor, in combination with xanthine oxidase inhibitors - two trials with allopurinol and one with Takeda's Uloric (febuxostat). The drug reached its primary endpoints, by reducing sUA levels. AstraZeneca is looking to file its 200mg combo dose. The incidence of renal-related adverse events and kidney stones was higher with Lesinurad 400mg plus an XO inhibitor. AstraZeneca's chief medical officer, Mr Briggs Morrison said that there is a significant unmet need, with 40-70 percent of gout patients not reaching the target levels of sUA with the current standards of care. He added that this data indicates that a combination therapy with Lesinurad may be a potential treatment option.     ]]> https://biospectrumindia.com/news/97/5006/ios8-to-have-a-spirometer-data-tracking-feature.html https://biospectrumindia.com/news/97/5006/ios8-to-have-a-spirometer-data-tracking-feature.html Sat, 16 Aug 2014 12:25:00 +0530 According to reports, in the iOS 8 beta, Apple has added a number of health-related features. Most notably, a data tracking capability for spirometry, which collects information like how constricted the lungs are in people with conditions like asthma or COPD. There are no smartphone connected spirometers in the market right now, but several companies like Respi, a Greek company, are working on the technology and are close to a launch. Industry people feel that Apple might be proactively preparing its app to interface with a device market that does not yet exist, or the spirometry feature could be designed, instead, to interface with medical devices in a hospital setting or accept manual inputs from users with non-connected spirometers or peak flow meters. This is not the first indication that respiratory diseases will be a focus for the health app - the original beta already had "Inhaler Usage" as a sole section under its medication tab. As per reports, the new update adds new data to the list of crucial stats that can be accessed even when the phone is locked. That screen will now include allergies and blood type - two pieces of information useful to doctors in an emergency situation. In addition, a Health option has been added to the iOS's privacy panel in the new update.   ]]> https://biospectrumindia.com/news/97/4938/now-an-economical-medical-testing-device.html https://biospectrumindia.com/news/97/4938/now-an-economical-medical-testing-device.html Fri, 15 Aug 2014 10:15:00 +0530 Harvard researchers have created an inexpensive detector that can be used by healthcare workers in the world's poorest regions to monitor diabetes, detect malaria and discover environmental pollutants. The device is in field trials in India. It costs about $25 to produce, weighs just two ounces, and is about the size of a pack of cigarettes. "We designed it to be as close as possible to a glucose meter, because that's familiar to people," said Mr Alex Nemiroski, a postdoctoral fellow in the lab of Flowers University Professor George Whitesides and lead author of a paper, released in the Proceedings of the National Academy of Sciences, describing the work. He added, "There are two buttons. Select the test and press 'go.' It should be a no-brainer." Mr Nemiroski and colleagues in Whitesides' Lab, the Wyss Institute for Biologically Inspired Engineering, the Kavli Institute for Bionano Science and Technology, Harvard's School of Engineering and Applied Sciences, and the University of Oviedo, Spain, worked on the device for nearly three years. He has turned the device over to entrepreneurs interested in commercializing the technology. Mr Whitesides said, "Our work had three objectives - to make a technologically versatile, hand-held electrochemical reader that was inexpensive and rugged; to demonstrate methods of programming and using this device to do a range of assays relevant in public health, diagnostics in resource-limited environments, and testing for safety and quality of water, food, and other health-related materials; and to make the information provided by the analysis easily uploadable to the Web over even low-end cellphones." In creating the device, Mr Nemiroski collaborated with experts in chemistry, biology, and other fields.   Mr Nemiroski focused on an electrochemical detector, which measures the voltage or current generated in liquids for characteristic signatures of the liquid's contents. For example, by applying a small amount of electricity to a drop of blood mixed with a reagent, the device can gauge glucose levels. The same goes for heavy metals in water, malaria antigens in blood, and sodium in urine. He has sent off five units to be field tested in India, and is already at work on the next generation of the device, which will have more features and be able to conduct more tests. "I'm really proud of the work and really proud of the team," He said. "I think there's a real need, and I think this is a real solution," he concluded.   ]]> https://biospectrumindia.com/news/97/4734/google-releases-google-fit-preview-sdk.html https://biospectrumindia.com/news/97/4734/google-releases-google-fit-preview-sdk.html Tue, 12 Aug 2014 16:19:00 +0530 Building on the presentation at the recent I/O Developers Conference, Google has released the Preview SDK for the Google Fit platform. Google Fit provides a single set of application program interfaces (APIs) that app developers and device manufacturers can use to store and access activity data from fitness apps and sensors. These sensors can exist on health devices like fitness wearables, smartwatches (with sensors), heart rate monitors, and connected scales. Developers will get access to three sets of APIs. A set of sensor APIs will give apps access to biometrics sensors on Android devices (like Samsung's Wear smartwatches). A Recording API lets an app collect user fitness data from the cloud. A History API allows apps to read, insert, or delete user health data in the Google Fit cloud. For example, when the exerciser finishes her run, the running app can query the History API for all locations during the run and show a map. Google said developers can start building app functionality using the data history stored on the device. But they will have to wait a little longer to be able to use health data from the Google Fit cloud.  To use the SDK, developers need to have the Android L Developer Preview system image with Google Fit support, available for the Nexus 5 and the Nexus 7 Wi-Fi version.   ]]> https://biospectrumindia.com/news/97/4710/biospectrum-asias-6th-annual-cro-survey-findings-to-be-announced-this-september.html https://biospectrumindia.com/news/97/4710/biospectrum-asias-6th-annual-cro-survey-findings-to-be-announced-this-september.html Mon, 11 Aug 2014 13:26:00 +0530 Bangalore: BioSpectrum Asia will highlight a whole host of issues facing the industry, while tracking the trends of the Asia Pacific region in its annual CRO survey this September. "In an effort to assess the ecosystem trends in Contract and Clinical Research Organizations (CROs) in the Asia Pacific region, we have been conducting an annual survey of the CRO industry since 2009," explained Mr Narayanan Suresh, Group Editor - BioSpectrum (India &Asia). The survey this year will highlight the growth and challenges faced by the industry in various Asian nations. The scope of the study will include perceptions of the industry as well as its performance. The findings of the survey will be published in the September issue and will include insights shared by the CEOs of CROs across the region. The survey will prioritize the policy changes in the clinical research sector in the last one year, the major newsmakers in the Asian market, the growing interest of MNC CROs in the local market through mergers or acquisitions. It would also simplify the data generated through the survey using a geographical mapping of clinical trials in Asia for major diseases. It will also explore country specific funding and investment trends. To participate in the coveted survey, please fill in the following survey form:http://www.surveygizmo.com/s3/1755114/6th-Annual-APAC-CRO-Survey ]]> https://biospectrumindia.com/news/97/4566/lenient-regulations-for-digital-medical-devices.html https://biospectrumindia.com/news/97/4566/lenient-regulations-for-digital-medical-devices.html Sat, 09 Aug 2014 15:55:00 +0530 The USA Food and Drug Administration (USFDA) has issued a new guidance that exempts medical devices from its regulatory scope. This means that the makers of these devices, some of which are connected to apps, no longer have to go through the FDA's review process before they bring their product to the market. The affected devices are largely clinical, including things like anesthesiology, cardiovascular, and dental. But a number of consumer mobile and digital health products are exempted as well, including thermometers, stethoscopes, talking first aid kits, hearing aids, fertility diagnostic devices, and exercise equipment. "The FDA believes that these devices are sufficiently well understood and do not present risks that require premarket 21 notification review to assure their safety and effectiveness," the FDA said in the advisory. "This is big news, and a huge boost to the mHealth industry. It shows that FDA is being extremely practical in reviewing its own practices and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources," said Mr Brad Thompson, Epstein Becker Green compliance attorney. The FDA will now open a 60-day comment period before issuing a final ruling on the matter.       ]]> https://biospectrumindia.com/news/97/4670/eyenetra-raises-4-million-for-a-smartphone-vision-test.html https://biospectrumindia.com/news/97/4670/eyenetra-raises-4-million-for-a-smartphone-vision-test.html Fri, 08 Aug 2014 18:41:00 +0530 Massachusetts-based eye diagnostic tool maker, EyeNetra has raised $4 million from a single investor, according to a report. EyeNetra has developed a device called NetraG that can be applied to mobile phones to create a smartphone vision test. The device can generate the recommended power for each person's eyeglasses and contact lenses. It is designed to test for near-sightedness, far-sightedness, and astigmatism. The company's website claims that its technology is as accurate as autorefractors, and less expensive. It aims to sell the device at a low price point. The company is also developing a data analytics component to identify patterns and trends to develop specific recommendations for each patient. The company was started in 2010 in the MIT Media Lab by Mr Ramesh Raskar, chief scientific officer and director of the Camera Culture Group at the MIT Media Lab and Mr Vitor Pamplona, chief technology officer, and COO and co-founder Mr David Schafran. Although it is not intended as a replacement for an eye exam, the company sees its biggest value in providing easy access to eye exams in developing countries. Undiagnosed refractive errors in the eye are among the leading causes of blindness. By the early detection of these problems, the device could improve outcomes for easily treatable conditions. The company expects consumers to use the product under the recommendation of their eye doctor and emphasises that it is not a substitute for a full eye exam. EyeNetra's clinical validation partners are India-based LV Prasad Eye Institute, Boston-based New England College of Optometry, and India-based Lotus Eye Hospital and Institute.   The company's website confirms that the device has been tested in India. Mr Schafran imnformed that the company is in the midst of clinical trials in Boston and outside the country.     ]]> https://biospectrumindia.com/news/97/4497/siemens-to-sell-its-health-it-business-.html https://biospectrumindia.com/news/97/4497/siemens-to-sell-its-health-it-business-.html Fri, 08 Aug 2014 15:13:58 +0530 Cerner is purchasing the health care information technology business of Siemens for $1.3 billion. The deal, which values the Siemens business at slightly more than a one time sale, will increase Cerner's annual revenue from about $3 billion last year to more than $4.5 billion this year. The combined company will have 20,000 associates in more than 30 countries, and 18,000 facilities that will be clients. "We think scale is important," said Mr Patterson, founder, Cerner. He added, "We were the largest IT company, but this gives us a bigger, better business platform. We'll have a combined $650 million [in research and development] spend and we think the future of healthcare computing is driven around the ability to innovate. This kind of preserves our ability to spend heavily in innovation and IT certainly for the rest of this decade." The scale and financial heft will help Cerner continue to compete with existing rivals like Epic Systems, which is becoming a dominant force in the health information technology space, AthenaHealth, and AllScripts.   ]]> https://biospectrumindia.com/news/97/4484/proteus-raises-52-million-for-a-meds-monitoring-system.html https://biospectrumindia.com/news/97/4484/proteus-raises-52-million-for-a-meds-monitoring-system.html Fri, 08 Aug 2014 11:01:15 +0530 A USA-based biotech company has made pioneering tablets containing embedded microchips that can tell if patients have taken their medication. The company has managed to raise $52 million, showing investor interest in its ingestible and wearable technology. The system uses a tiny ingestible sensor that patients swallow with their medication every day. The sensor contains tiny amounts of magnesium and copper that react together and send a signal to a battery-operated patch that's worn on the patient's abdomen. The patch, which lasts about a week, reports its data to a tablet or smartphone via Bluetooth, and the device forwards the information to the cloud. Once the data is in the cloud, it can be monitored by doctors and other caregivers. A handful of health systems in the USA and UK are now testing the Proteus system in what is called a "private beta." The company has not informed when the product will become generally available. "Investor confidence in Proteus is driven by customer excitement, our superior board and leadership team, and a unique technology platform that enables us to link one of the most valuable industries of the 20th century - pharmaceuticals - to the most important utility of the 21st: the mobile Internet," said Proteus CEO Mr Andrew Thompson in a statement.   ]]> https://biospectrumindia.com/news/97/4478/phenomenex-launches-a-phenova-crm-for-environmental-labs.html https://biospectrumindia.com/news/97/4478/phenomenex-launches-a-phenova-crm-for-environmental-labs.html Fri, 08 Aug 2014 10:37:12 +0530 Phenomenex, a global leader in the research and manufacture of advanced technologies for separation sciences, has announced the addition of Phenova Certified Reference Materials (CRMs) - a comprehensive line of ISO/IEC 17025- and ISO Guide 34-compliant standards. Phenova CRMs are manufactured by Phenova, an established environmental proficiency-testing (PT) provider, sold and distributed exclusively by Phenomenex. Phenova brings the same precision to its CRM manufacturing process, underlined with the same methodical quality commitment, that has proved successful in manufacturing PT standards. "Analysts depend on CRM performance to quantitate and qualify their results," explained Mr Sassan Tamaddoni, brand manager, Phenomenex. He added, "Extreme accuracy is essential and the laboratory and PT manufacturing experience of Phenova's chemists plays a critical role in delivering consistent quality and reliability to our customers." Phenova CRMs deliver batch to batch consistency with the verification of each batch with both internal and independent CRM materials. This ultimately provides a competitive product that allows customers to extend their initial calibrations and increase throughput between processes. Phenomenex has implemented a series of added benefits to fortify the company's entry into the CRM market such as a free sample program, multiple-batch inventory, a dedicated technical support team, and a novel packaging configuration that delivers on safety, unique labelling, and organization.   Phenova CRMs complement Phenomenex's portfolio of GC and LC products and accessories specialized for the environmental industry and are currently available in the US and Canada.   ]]> https://biospectrumindia.com/news/97/7803/medtronic-launches-new-pacemaker-in-india.html https://biospectrumindia.com/news/97/7803/medtronic-launches-new-pacemaker-in-india.html Thu, 07 Aug 2014 15:16:20 +0530 "The unique diagnostic capabilities of this smart device will help improve function throughout the continuum of care," said Mr Milind Shah, MD & VP South Asia, India Medtronic. The product includes the Medtronic-exclusive AdaptivCRT software, which is the only algorithm demonstrated to improve heart failure patients' response to therapy, and reduce the risk of atrial fibrillation. "We are proud to introduce this latest innovative medical technology for the treatment of cardiac arrhythmias, to help deliver clinical as well as economic value to patients in India," he commented. ]]> https://biospectrumindia.com/news/97/4380/epiviz-a-tool-to-analyze-human-genomic-data.html https://biospectrumindia.com/news/97/4380/epiviz-a-tool-to-analyze-human-genomic-data.html Tue, 05 Aug 2014 18:00:00 +0530 Researchers at the University of Maryland (UMD) report the development of a new, web-based tool that enables researchers to quickly and easily visualize and compare large amounts of genomic information resulting from high-throughout sequencing experiments. The free tool, called Epiviz, was described in a paper (Epiviz: interactive visual analytics for functional genomics data) published online in Nature Methods. "Epiviz seamlessly integrates with the open-source Bioconductor analysis software widely used by genomic scientists, through its Epivizr Bioconductor package," said Mr Héctor Corrada-Bravo, PhD assistant professor in computer science at UMD. "Epiviz, a web-based genome browser, and the Epivizr Bioconductor package allows interactive, extensible, and reproducible visualization within a state-of-the-art data-analysis platform," explained the investigators. "Prior tools limited visualization to presentation and dissemination, rather than a hybrid tool integrating interactive visualization with algorithmic analysis," explained Mr Corrada-Bravo. It supports many popular next-generation sequencing techniques, such as ChIP-seq, which is used to analyze protein interactions with DNA; RNA-seq, which reveals a comprehensive snapshot of the abundance of RNAs in cells; and DNA methylation analyses.   Epiviz links data across different visualizations giving users visual insights of the spatial relationships of multiple datasets. The tool is designed to allow biomedical scientists to easily incorporate their own visualizations. "Epiviz helps biomedical scientists meet the challenge of visualizing large genomic datasets while supporting creative data analysis in a collaborative environment," he pointed out. ]]> https://biospectrumindia.com/news/97/4227/drug-approval-process-to-go-online.html https://biospectrumindia.com/news/97/4227/drug-approval-process-to-go-online.html Mon, 04 Aug 2014 18:29:59 +0530 The Drug Controller General of India (DCGI) is planning to shift the process of approving clinical trial applications online. Every trial would be given a unique identity number and pharmaceutical companies, ethics committees, doctors or investigators conducting trials would be asked to regularly update information in the online database, including patients' personal details, serious adverse effects that they may suffer and compensation paid out to them by companies, according to a draft proposal firmed up by the drug regulator. Information about a investigational product such as the medical condition it seeks to address, the profile of that disease in India, would have to be uploaded. Also the specifics of the investigator or doctor conducting the trial such as his team, site and whether parts of the clinical trial are being conducted in other parts of the world also need to be mentioned. The proposed comprehensive database will contain information about the targeted patient population, and whether any high risk or vulnerable patients' groups such as infants, children, women of childbearing potential or lactating women are participating in the trial. Detailed disclosures may be sought, not only on the composition of the ethics committee and how frequently they meet but also the proceedings of their meeting may have to be uploaded once the trial begins, according to the draft. This move comes after the union health minister, Mr Harsh Vardhan, during a recent briefing, asked officials from the regulator's office to ensure complete transparency in their functioning. Officials at the drug regulator's office maintain that consultations with stakeholders are on and all legitimate concerns around patients' confidentiality would be taken care of.   "It is a work in progress and the idea is to eventually graduate to a paperless system," an official at the drug regulator's office said. The Supreme Court is currently hearing a public interest litigation on whether existing rules and regulations of the country adequately protect clinical trial subjects, particularly those participating in trials of new chemical entities.   ]]> https://biospectrumindia.com/news/97/4186/bring-medical-device-industry-under-dpco-maha-fda.html https://biospectrumindia.com/news/97/4186/bring-medical-device-industry-under-dpco-maha-fda.html Sun, 03 Aug 2014 16:24:00 +0530 The Maharashtra Food and Drug Administration (FDA) has suggested, to the Drug Controller General of India (DCGI) and the National Pharmaceutical Pricing Authority (NPPA) that medical devices should be brought under the Drug Price Control Order (DPCO), to make them affordable to patients. Medical devices are notified as drugs under the Drugs and Cosmetics Act, 1940 but are not included under the DPCO. Therefore, the prices of medical devices cannot be monitored or controlled. The recommendation comes in the wake of studies conducted by the FDA which has revealed that manufacturers in connivance with importers, distributors, and hospitals are fixing the MRP of medical devices arbitrarily. The study observed that the MRP of a product was set high and the patients had no bargaining options. The drug authority believes that under the new DPCO regime, the prices of these products could be monitered and would also help curb profiteering.       ]]> https://biospectrumindia.com/news/97/4142/medical-devices-pharma-machinery-to-come-under-eepc.html https://biospectrumindia.com/news/97/4142/medical-devices-pharma-machinery-to-come-under-eepc.html Sat, 02 Aug 2014 12:10:00 +0530 The Government has recently announced that the Engineering Export Promotion Council (EEPC), India will henceforth handle the export related issues and promotional activities of the medical device and pharma machinery industries. Pharmaceutical Export Promotion Council of India (Pharmexcil) was handling the sectors until recently. EEPC deals with export promotion of engineering goods, projects and services from India. The information shared by the ministry of commerce was well received by the industry as experts feel that the exporters of medical devices and pharma machinery will get the right platform to present their issue and concerns before the government. "Though Pharmexcil is a very competent forum, it had very little role to play in the medical device industry since it mainly deals with only the promotion of the pharma industry. This made us feel left out from the incremental and development scope, which will hopefully change now with the sector being migrated to EEPC. Now that a suitable forum has been established to represent our cause, we hope to see positive change in the business, with adequate focus being rendered to industry specific issues," stressed Mr D L Pandya, chief executive officer, Medical Plastics Data Service. He further said that to get better exposure they have also demanded inclusion of the supply chain companies for medical devices and pharma machinery under the ambit of EEPC. ]]> https://biospectrumindia.com/news/97/4084/cognizant-to-develop-a-clinical-trial-collaboration-platform-.html https://biospectrumindia.com/news/97/4084/cognizant-to-develop-a-clinical-trial-collaboration-platform-.html Fri, 01 Aug 2014 17:21:59 +0530 Cognizant has announced that it had been selected by TransCelerate BioPharma, a non-profit organization, with membership representation from 19 major pharmaceutical companies, to develop a first-of-its-kind, subscription-based platform that will transform the way clinical sites collaborate with pharmaceutical companies for clinical trials. The Shared Investigator Platform, which will be built as an 'industry utility', will enable the pharmaceutical industry to bring standardization and consistency to clinical trials. Investigator platforms are often deployed by each pharmaceutical company resulting in clinical sites using multiple environments, introducing complexity and risk. By bringing together clinical sites and sponsors spread across the world on a common platform, companies can run trials more efficiently and accelerate the development of new medicines. The new platform will enhance organizational productivity by providing investigators and site staff with a central, single access point to clinical trial information, enhancing accuracy, and reducing study start-up time. It will also help pharmaceutical companies improve quality, regulatory compliance, process visibility, and capacity, while reducing investigator efforts related to training, document exchange, and support. "This collaboration is an important part of TransCelerate's strategy to improve clinical trial processes in order to bring innovative new medicines to patients faster," said Mr Jackie Kent, senior director, clinical development information and optimization, Eli Lilly and shared investigator platform leader, TransCelerate. "The Shared Investigator Platform will benefit sites by simplifying processes, and reducing time and effort spent on standard study activities. TransCelerate conducted a comprehensive selection process for this initiative and Cognizant provided the key attributes required for this unique partnership. We anticipate an overall improvement in the quality of studies and the data generated from the Shared Investigator Platform initiative," he added. "We are pleased to partner with TransCelerate to build this first-of-a-kind platform, which will help maximize the potential of technology-based collaboration and provide better medicines to patients, greater efficiency to clinical sites, and superior business outcomes to pharmaceutical sponsors," said Mr Bhaskar Sambasivan, VP of Cognizant's lifesciences division. He added, "Streamlining the clinical trial process will enable TransCelerate's member companies to not only speed up drug development, but also drive innovation to improve patient health. We are making significant commitment and investment in this strategic relationship, and will leverage our industry expertize and technology capabilities to ensure that the proprietary platform, built as an industry utility, delivers optimal value. We will also seek inputs from end-users to continually enhance the platform."   ]]> https://biospectrumindia.com/news/97/3892/india-is-our-biggest-market-in-apac-west-pharma.html https://biospectrumindia.com/news/97/3892/india-is-our-biggest-market-in-apac-west-pharma.html Mon, 28 Jul 2014 15:04:18 +0530 The plant is said to be constructed with an investment of $15 Million, which has been in the making for the last two years, since 2012. The facility will produce seals used in primary packaging of injectable medicines. West also revealed that in future it plans to expand its production at the same site to include its elastomer component business. Mr Warwick Bedwell, president - APAC, West Pharmaceutical Services, exclusively spoke to BioSpectrum on the occasion. Excerpts: Q: Can you tell us about the new manufacturing facility in Chennai? We have been in business for 90 years in the US and we are the largest global supplier of primary packaging for injectable medicines components in APAC. This is our fourth plant in the APAC, and we have 30 plants globally. This plant will be involved in 100 percent exports, and employing 45 professionals.   Besides India, we also have a plant in Singapore inaugurated in 1993, and 2 plants in Qingpu, China, inaugurated in 2009 and 2012 respectively, in the APAC region. We have invested USD 15 million towards this new facility. The plant will be able to produce 1.6 billion components annually by 2018. This facility center will be a center of excellence for seal production used in primary packaging of injectable medicines for APAC. This is a high volume business. Companies wishing to manufacture medicines in India, especially MNCs like Hospira, Sun Pharma, Dr Reddy's and other major pharma companies in India. We'll also produce elastomer components in the next 5 years. The growth in the APAC is growing about 12-13percent. And it is fairly a large market. For us, India has the largest market share and revenue strength in the APAC region. India exports about $15 billion worth medicines globally. We chose it mainly because of the availability of land, labor, utilities, logistics and financial viability. Q: Who are your competitors?   In India, we have small scale industries in Bangalore and Ahmedabad, manufacturing components for injectable medicines packaging. Hence, we do not have intense competition. Q: Can you compare India and China's performance for West? Both India and China's performance have been good, however, India's performance has been exceptionally well. India is the biggest market in the APAC region. It is now serving as a hot hub for CMOs and MNCs. Soon, all our four major plants in the APAC region will become a hub for manufacturing all our components. Q: Are you open to collaborations? We are open to innovation and innovation doesn't always come from inside. We have a history of acquiring companies and bring in new products for patients.   Q: With this new facility how do you intend to expand? We are already in Singapore and China. We don't intend to build another plant at this point. Instead, we'll aim to expand in India. There is plenty of space here in our new facility, measuring about 72,000 sq meters. Q: What are the key trends that you see in the injectables packaging business? It is definitely showing a good growth around the world. Most biologics and hospitals need injectable medicines. The global pharmaceutical industry manufactures products that are much more than normal solid dosage forms. Especially, Oncology and insulin products are mostly injectables. Hence the market is growing twice as fast as the solid dosage forms. Q: Overall, how has the market performed for West in the APAC?   Mostly the performance depends on the market where we are. We are the largest supplier globally and in India. Overall, we are the only company in this business that has a footprint that covers all of the APAC region. Q: According to you, what are the major industry challenges? Affordability and access to medicines to patients is the primary challenge. Quality is also another issue. Pharmaceuticals products should not only be efficacious but also safe at the same time.                  ]]> https://biospectrumindia.com/news/97/7638/a-jugaad-a-thon-for-open-innovation.html https://biospectrumindia.com/news/97/7638/a-jugaad-a-thon-for-open-innovation.html Mon, 28 Jul 2014 12:24:00 +0530 Consortium for Affordable Medical Technologies (CAMTech) organised a jugaad-a-thon, a medical technology hack-a-thon to drive innovation in reproductive, maternal, newborn and child health. The event was hosted by GE healthcare India. The Jugaad-a-thon's non-stop "48 hours of innovation" brought together 250 engineers, doctors and entrepreneurs. After two days of around-the-clock work by participants and mentors, 34 new potential solutions were presented to a panel of judges - ranging from new tools for antenatal care to disruptive technologies for newborn asphyxia. "The energy and level of innovative thinking in this hack-a-thon surpassed any expectation we had," said Ms Elizabeth Bailey, director, CAMTech. She continued, "Over these 48 hours, we saw clinical challenges drive innovative ideas, which then spawned new life-saving technologies for women and children in India. The Jugaad-a-thon was open innovation at its best." Mr Vikram Damodaran, director, healthcare innovation, India and GE Healthcare South Asia said, "We have seen several new creative ideas in just 48 hours that can change the way we look at reproductive, maternal and infant care. It is a completely new experience for us and we believe co-creation of solutions can accelerate affordable healthcare innovation. We are very pleased to have been a part of this program led by CAMTech INDIA. We hope to do more 'Jugaad-a-thons' to promote open innovation and co-creation in healthcare industry." The winners of the event was:   •Top Prize: Team "Baby Steps" received Rs 2,50,000 ($4,100) for developing a unique and integrated mobile app for early diagnosis of developmental delays in children across India. •First Runner Up: Team "Pec Dia" received Rs 1,50,000 ($2,500) for developing a solution to diagnose Cephalopelvic Disproportion (CPD) in pregnancies after 37 weeks by any healthcare worker. •Second Runner Up: Team "Pregmatic" received Rs 75,000 ($1,250) for the development of an affordable wearable device that reminds pregnant women about key milestones in pregnancy when they must see a medical professional. All three of the cash prize winners also received three years of incubation support at the Mazumdar-Shaw Medical Center's Healthcare Technology Incubator. There were also prizes awarded by three corporate sponsors. ABInBev championed the cause of road safety technologies for children. Covidien supported several clinical problems in need of innovation, including newborn asphyxia, fetal/maternal monitoring and post partum hemorrhage. And the Novartis Foundation challenged the Jugaad-a-thon participants to come up with new approaches to diagnosing Leprosy. Each winning team will also receive Rs 50,000 and ongoing support from the companies. Additional prizes included in-kind support from Dayanda Sagar Institutions (incubation services), InnAccel (acceleration services), and the Wellcome Trust (fundraising and grant writing mentorship).   ]]> https://biospectrumindia.com/news/97/3765/advaxis-medimmune-collaborate-over-immune-oncology-trial.html https://biospectrumindia.com/news/97/3765/advaxis-medimmune-collaborate-over-immune-oncology-trial.html Fri, 25 Jul 2014 14:03:28 +0530 MedImmune enters into a partnership with Advaxis for a immuno-oncology combination clinical trial. The immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. MEDI4736 is designed to counter the tumor's immune-evading tactics by blocking a signal that helps tumors avoid detection, while ADXS-HPV enhances the ability of immune cells to combat the tumor. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can enhance overall anti-tumor response. "Our collaboration with Advaxis is further evidence of MedImmune's commitment to explore novel combination approaches as we progress our immuno-oncology portfolio," said Dr Bahija Jallal, executive vice president, Medimmune. He added, "We believe there could be an important clinical benefit from the combination of MEDI4736 with Advaxis's antigen-specific cancer vaccine." MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase 1 part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase 2 portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted. "We are excited to be partnering with MedImmune and evaluating MEDI4736 in combination with our immunotherapy," said Mr Daniel O'Connor, chief executive officer, Advaxis."This is the first time a PD-L1 checkpoint inhibitor will be used with a new class of immunotherapies. As multiple companies vie for a competitive advantage in the future PD-L1 market, the ability of our immunotherapy platform to attack multiple tumor targets makes it an attractive combination therapy," he further said.     ]]> https://biospectrumindia.com/news/97/3646/oxford-instruments-opens-its-first-nanotech-lab.html https://biospectrumindia.com/news/97/3646/oxford-instruments-opens-its-first-nanotech-lab.html Fri, 25 Jul 2014 10:30:00 +0530 Oxford Instruments opened its first Nanotechnology lab for atomic force microscopy located at its India headquarters in Mumbai. It adds to the company's range of industrial analysis tools available for demonstration. This lab is an initiative to offer its customers high quality products and services, and provide the same high standard of service to Indian researchers. Asylum Research is known for their technology leadership in AFM, ranging from the affordable MFP-3D Origin AFM to the most advanced Cypher ES, the highest resolution fast scanning AFM that also features full environmental control. The AFM Lab in India is equipped with the MFP-3D Classic and the MFP-3D Origin for demonstration. The MFP-3D Origin, the most affordable member, offers high performance equal to the MFP-3D Classic and an impressive selection of options and operating modes. It also offers full upgrade potential. The MFP-3D Classic offers maximum versatility with the widest range of accessories for nano-mechanical, and nano-electrical characterisation, and powerful environmental control capabilities. The AFM lab is staffed by a dedicated business manager, Mr Manju Kumar, and AFM applications scientist, Mr Kishore Kumar.   ]]> https://biospectrumindia.com/news/97/5980/philips-healthcare-gets-a-new-president.html https://biospectrumindia.com/news/97/5980/philips-healthcare-gets-a-new-president.html Tue, 22 Jul 2014 16:00:33 +0530 Phillips Healthcare has announced the appointment of Mr Sameer Garde as the president for the South Asia region.  Mr Garde's tenure becomes effective from July 22, 2014 and he will be based in Gurgaon. In his new role, he will be responsible for driving and building the healthcare business for Philips in India. He replaces Mr Krishna Kumar, who continued to lead the Philips Healthcare business following his appointment as vice chairman and managing director, Philips India in December 2013. Mr Garde has extensive experience in a career spanning over 24 years. He started his career in the consumer industry before transitioning to the B2B segment. He brings in extensive experience in driving sales and defining marketing growth opportunities for both B2C and B2B companies. He has worked with many industry giants such as Whirlpool, Dell International, Nestle, Pepsi, and Samsung. Speaking about his new role, Mr Garde said, "I am looking forward to this new role and am excited about working with the Philips Healthcare team to strengthen our leadership in the healthcare space in India." Mr Krishna Kumar, vice chairman and managing director, Philips India commented, "I welcome Mr Garde to the Philips team and am confident that he will lead Philips Healthcare to a bigger heights and excellence. He typifies the high quality leadership that we have on board as we look towards tapping opportunities to provide access to affordable healthcare in India." Philips Healthcare India provides an end-to-end ecosystem spanning across R&D, manufacturing, service and clinical applications.   ]]> https://biospectrumindia.com/news/97/3855/skanray-acquires-italian-x-ray-firm.html https://biospectrumindia.com/news/97/3855/skanray-acquires-italian-x-ray-firm.html Tue, 22 Jul 2014 13:21:41 +0530 Mysore-based manufacturer of medical equipment, Skanray Technologies, has acquired CEI-Italy (Compagnia Elettronica Italiana), one of the major x-ray tube makers in the world. The companies did not disclose the value of the deal. CEI has 5 million euros (Rs 41 crore) in revenue. In 2008, Skanray had picked up a minority stake in CEI. The latest move follows Skanray's establishment of its own R&D unit in Europe late last year. "X-ray tubes are made by only some 6-7 companies in the world. It's complex technology. Now that we have our own x-ray tubes, we can build x-ray machines that are much better integrated, and take them to the next level. Our R&D unit in Europe will also work towards that," said Skanray founder Mr Vishwaprasad Alva. Skanray commenced commercial production in 2011 and has today grown to a team of 500 medical technology professionals, with operations in India, Europe and Latin America. It had about Rs 117 crore revenue last year. It makes products for radiology, critical care, patient monitoring, primary healthcare solutions and telemedicine. Mr Alva says his products are priced at one-third to one-fourth of that of imported ones. "Our development cost is one-twentieth of that in Europe, US or Japan. Component costs are about 40 percent lower. Our radiation safety parameters are the best in the world," he said. Skanray sells under its own brand, and also supplies its products to other global medical equipment companies to sell under their brand. In India, it has an installed base of 1.1 lakh units, and customers include most major hospitals, as also diagnostic centers and nursing homes. Competition in this space is now emerging from global companies like Philips, GE Healthcare and Siemens, all of who are building products to meet the price-performance requirements of India.   With CEI and the European R&D center, Skanray hopes to turn the heat on the global players in their own home bases.   ]]> https://biospectrumindia.com/news/97/3150/govt-to-set-up-a-medical-device-testing-laboratory.html https://biospectrumindia.com/news/97/3150/govt-to-set-up-a-medical-device-testing-laboratory.html Mon, 21 Jul 2014 13:24:40 +0530 Officials from the Union commerce ministry, in a meeting, stated that there are plans to set up at least five incubation centers across the country, each at a cost of around Rs 100 crore that would help R&D activities. Mr Sudhanshu Pandey, joint secretary, ministry of commerce and industry, government of India said, "Such incubation centers would help scientists, engineers, and entrepreneurs who can pay a certain fee and use the center's infrastructure. This could be a huge boost to R&D and product development, as there would be no need to set up a full-fledged R&D facility by each company." There are also plans to set up testing laboratories across the country to test medical devices. This could ease the process of certification and, in turn, boost export prospects for Indian players. Ahmedabad, which is one of the hubs for medical devices and pharma machinery manufacturing in the country, is likely to get a testing laboratory. The ministry of commerce is also planning to set up a panel with representations from different streams like medical devices, pharmaceutical machinery etc. under EEPC India (formerly the Engineering Export Promotion Council). India's $3.5 billion market for medical devices and equipment is dominated by imports, which account for 65 percent share of medical devices.   While the industry is growing at a rapid pace of 15-20 percent, there is a big scope for improvement on exports of the pharma machinery. Engineering skills also need to be worked on, just as the country has built a reputation of being a major supplier of generic pharmaceuticals," said Mr B Sarkar, executive director and secretary, EEPC India. He added, "We are facing a peculiar problem when it comes to trade with our neighboring countries. While imports of pharmaceutical machinery are being dumped into India from China, we are confronted with an embargo on our machinery exports to Pakistan. We have taken up these issues with the government."     ]]> https://biospectrumindia.com/news/97/3854/a-wearable-healthcare-device-for-diabetics.html https://biospectrumindia.com/news/97/3854/a-wearable-healthcare-device-for-diabetics.html Sun, 20 Jul 2014 10:00:00 +0530 Novartis explained that the device for diabetics would measure glucose in tear fluid and send the data wirelessly to a mobile device. The technology is potentially life-changing for many diabetics, as it will save them from pricking their fingers daily. Non-invasive sensors, microchips and other miniaturised electronics would be embedded into the contact lenses. According to reports, as per the agreement, Novartis's Alcon eyecare unit will further develop and commercialize the lens technologies designed by Google. However, any financial details were not disclosed. The alliance comes as drug makers explore ways for technology to reshape healthcare, helping patients to monitor their own health and lowering the costs of managing chronic diseases. Novartis chief executive Mr Joe Jimenez said that he hoped that a product could be on the market in about five years. "This really brings high-technology and combines it with biology, and that's a very exciting combination for us," He said. "I think you're going to see more and more areas of unmet medical needs being met, where companies like Novartis are going to take a non-traditional approach to addressing those needs." he added Although the licensing deal is only for the eye, he said that the drug maker was also thinking about how technology can be applied in other areas, such as remote patient monitoring in heart failure.   ]]> https://biospectrumindia.com/news/97/3849/vc-funding-in-healthcare-it-doubles-in-q2-of-2014.html https://biospectrumindia.com/news/97/3849/vc-funding-in-healthcare-it-doubles-in-q2-of-2014.html Fri, 18 Jul 2014 10:08:00 +0530 Mercom Capital Group, llc, a global communications and consulting firm, has released its report on funding and mergers and acquisitions (M&A) activity in the Healthcare Information Technology (IT) sector for the second quarter of 2014. Mercom's comprehensive report covers deals of all sizes in Healthcare IT across the globe. Venture capital (VC) funding in the sector more than doubled with $1.8 billion raised in 161 deals, a 104 percent increase compared to the $861 million raised in Q1 2014. Ten of those deals were for more than $50 million each. The $2.6 billion raised so far this year has already exceeded the $2.2 billion raised in all of 2013. There were 263 investors that participated in these funding rounds, with 58 angel investors including some well-known celebrities and entrepreneurs. The quarter also included 30 corporate venture capitalists. "It was a quarter of several milestones. It was the first billion dollar fundraising quarter for the Healthcare IT sector which has now raised almost $7 billion in venture funding since 2010. M&A deals were also at their highest this quarter, while Mobile Health companies continued to outraise other technologies," commented Mr Raj Prabhu, CEO and Co-Founder of Mercom Capital Group. Practice-centric companies received 61 percent of all VC investments in the second quarter of 2014, with $1.1 billion in 61 deals. Areas that received the most funding under this category were Practice Management with $220 million in eight deals, Data Analytics with $204 million in nine deals, Population Health Management with $144 million in four deals. Consumer-centric companies received $678 million in 100 deals, with the majority of the funding again going into the Mobile Health category ($401 million in 45 deals). Within Mobile Health, $129 million went to 23 companies developing Apps, $226 million went to 17 companies developing Wearables. Personal Health companies received $115 million in 23 deals and Scheduling, Rating and Shopping companies received $61 million in 12 deals. There were 38 early-stage deals under $2 million in Q2. The top VC funding deals over $100 million in Q2 2014 were the $135 million raise by NantHealth, a cloud-based healthcare IT company delivering care through a single integrated clinical platform, from the sovereign wealth fund, Kuwait Investment Authority and BlackBerry, the $130 million raise by Flatiron Health, a developer of a cloud-based business and clinical intelligence oncology data platform, from Google Ventures, First Round Capital and Laboratory Corporation of America, the $125 million raised by Alignment Healthcare, a provider of population health management solutions, from General Atlantic, and the $120 million raise by Proteus Digital Health, a developer of products and services integrating medicines with ingestible sensors, wearable sensors, mobile and cloud computing, from undisclosed institutional investors in the United States, Europe and Asia.Globally, U.S. companies raised $1.6 billion from 140 of the $1.8 billion total and 161 deals. Thirteen other countries recorded at least one deal apiece. In the United States, 47 deals came out of California, followed by New York which recorded 12 deals, Massachusetts with eight deals, and Texas and Tennessee with seven deals each. Among cities, San Franciso had the highest number of funding deals among cities with 18 followed by New York with 11. In terms of dollars, the order was reversed with New York coming out on top with $247 million, followed by San Francisco with $206 million. There were a record number of M&A transactions in the Healthcare IT sector in Q2 2014, with 57 transactions (12 disclosed) compared to 54 transactions (six disclosed) in Q1 2014. Health Information Management companies saw the most M&A activity this quarter with 20 transactions, followed by Revenue Cycle Management and Service Providers with 11 transactions each, and Mobile Health and Personal Health companies with six transactions each. Of the Top 5 M&A transactions, the largest was the $550 million leveraged buyout of ABILITY Network, a provider of web-based workflow solutions that aid clinical and administrative tasks for acute and post-acute healthcare providers, by Summit Partners, a growth equity investment firm. This was followed by the $532.5 million acquisition of Evolution1, a provider of payment solutions to healthcare companies, by WEX, a provider of corporate payment solutions. St Jude Medical, a medical device company, acquired privately held CardioMEMS, provider of a wireless sensing and communication technology designed to improve management of chronic cardiovascular diseases, for nearly $450 million. Other top disclosed transactions were the $225 million acquisition of ISG Holdings, which through its subsidiaries, provides medical bill review and managed care programs for the workers compensation industry, by Xerox, followed by the $150 million acquisition of Corventis, provider of a wearable technology with a focus on cardiovascular devices used for remote patient monitoring, by Medtronic, a medical-device company. Announced debt and public market financing in Healthcare IT amounted to $1.5 billion in five deals in Q2 2014, compared to $343 million in six deals in Q1 2014. There were two Healthcare IT IPOs in Q2 2014, bringing in a combined $1.4 billion. IMS Health, a provider of information services and technology for the healthcare industry, raised $1.3 billion through its IPO in April and Imprivata, a provider of authentication and access management security solutions for the healthcare industry launched an IPO that raised $86.3 million. Total corporate funding in the Healthcare IT sector, including VC, accelerator/incubator, debt, and public market financing, in Q2 2014 came in at $3.3 billion. There were a total of 549 companies and investors mentioned in this report. ]]> https://biospectrumindia.com/news/97/4018/gvk-bio-launches-clinogent-.html https://biospectrumindia.com/news/97/4018/gvk-bio-launches-clinogent-.html Fri, 18 Jul 2014 09:51:00 +0530 In a bid to race ahead to be among the top three Asian clinical research organizations in the next five years, India's Hyderabad-based contract research company GVK Biosciences (GVK BIO) has unveiled a new brand. "GVK BIO is well-known as a discovery services company. Today in our estimate we are No 4 or No 5 in the country in clinical research and clinical development. Our goal is to be in top three in Asia in the next five years through the new brand Clinogent," Mr Manni Kantipudi, Chief Executive of GVK Biosciences said at the official announcement. The firm unveiled a new brand, 'Clinogent', in the clinical development industry to offer integrated clinical trial outsourcing solutions. "The launch of the new brand, Clinogent is part of GVK BIO's growth plan in taking the organization to the next level and creating a benchmark in the industry," he added. Ahead of its growth plans, the firm also plans to increase its bed capacity by 50 at its Ahmedabad facility. This would help in carrying out clinical trials and starting an analytical laboratory in the next three months. "We are looking to expand our capacity. We have space in Ahmedabad facility. We are starting with a bio-analytical laboratory in Ahmedabad and add another 50 beds in Ahmedabad," Mr Chetan Tamhankar, Senior Vice-President (Clinical Development), GVK BIO said at the announcement. The new addition of beds will be to the company's existing facilities in Hyderabad and Ahmedabad. With its new brand, the company is hoping to further strengthen its operational expertise and technology to evolve into a specialist and comprehensive service offering entity in the clinical research and development market, Mr Kantipudi explained. He added, "Clinogent will be a clinical development service provider, which will be able to address the clinical needs of both innovator bio-pharmaceutical and generics companies world-wide."   ]]> https://biospectrumindia.com/news/97/6513/west-pharma-enters-india-with-new-plant.html https://biospectrumindia.com/news/97/6513/west-pharma-enters-india-with-new-plant.html Thu, 17 Jul 2014 17:10:00 +0530 US drug packaging major West Pharmaceutical Services has announced that it has set up a manufacturing plant in Chennai, India. The plant is about 55 kms from Chennai in Sri City Special Economic Zone. The company said in its official statement that it is investing about $15 million in the plant that will help the company expand its primary packaging for injectable medicines business. Mr Donald E Morel, Jr., West's chairman and chief executive officer said, "West is experiencing a very exciting period of growth and business expansion in Asia and we are proud to open our first facility in India. With more and more pharmaceutical customers establishing operations in India, our new plant will help West meet market demand and further establishes the company's presence in this growing and dynamic market." As per a news report, West Pharma had signed a 99-year lease on 72,800 sq m in Sri City in June 2012. Construction on a 15,300 sq m facility began in August 2012. The company has said that this facility will produce seals used in primary packaging of injectable medicines manufactured by West's pharmaceutical and biopharmaceutical customers in India and the wider Asia Pacific region. News reports explained that the company had no future plans to expand production at the site to include West's elastomer component business. "This investment is important to our strategy of partnering with customers in India and the Asia Pacific region to help them provide medicines to patients more efficiently, reliably and safely," said Mr Warwick Bedwell, president, Pharmaceutical Packaging Systems, Asia Pacific region.   He added, "With the facility complete, we anticipate a reduction in lead times for supply to our customers in India. By leveraging our global sourcing activities and process engineering expertise, we expect to be able to carefully manage the overall costs of production."   ]]> https://biospectrumindia.com/news/97/2984/infosys-and-smart-to-develop-mobile-solutions-for-healthcare.html https://biospectrumindia.com/news/97/2984/infosys-and-smart-to-develop-mobile-solutions-for-healthcare.html Sat, 12 Jul 2014 11:08:00 +0530 India's Infosys has signed a deal with Smart Communications to develop mobile solutions that would allow organizations to listen, respond and make predictions based on machine-generated data. "Our shared vision of 'Internet for Everything' will help enterprises rely on their remote assets and connected devices to transform their business. The center of excellence is expected to accelerate solutions development, streamline product delivery and give rise to new business models that help enterprises run more effectively and stay competitive," said Mr Jovy I Hernandez, PLDT, first vice president and head of PLDT ALPHA Enterprise and Smart Enterprise."We believe that the Smart-Infosys relationship, backed by the center will allow us and our clients to have more efficient operations and generate new revenue streams," he added. Mr Dheeshjith VG, Infosys senior vice president, said forward looking enterprises are seeking new ways to deliver a more positive and differentiated customer experience while reducing cost and simplifying technology to sustain growth in today's digital economy. He added,"The teaming up of two innovative companies, Infosys and Smart Enterprise, will help businesses better understand their customers and market conditions, which are dynamically changing in our 'connected' world. Open collaboration with the ecosystem will allow our clients to test new concepts for intelligent systems while simultaneously reducing risk."   ]]> https://biospectrumindia.com/news/97/3305/shimadzu-launches-new-industry-standard-hplcs.html https://biospectrumindia.com/news/97/3305/shimadzu-launches-new-industry-standard-hplcs.html Fri, 11 Jul 2014 16:32:49 +0530 Shimadzu Corporation announced the global launch of its i-Series of New Industry Standard HPLCs (High Performance Liquid Chromatograph) systems. The i-series improves productivity and promotes an advanced laboratory environment with operation capabilities from built-in touch panel and smart device, thereby enabling a PC-free laboratory. The i-Series consists of Prominence-i, and the Naxera-i which supports conventional to high-speed analysis, which supports ultra-high speed analysis. These integrated HPLC systems propose a completely new operating environment and realize a PC-free laboratory by enabling control of the instrument from a smart device, such as a smart phone, and via a newly developed Interactive Communication Mode (ICM). In addition to improved performance and higher reliability, the i-Series offers an intuitive operating environment that allows anyone to analyse samples easily. Furthermore, full automation, from start-up to shut down after analysis, and a direct access function that allows multiple operators to set samples at any time, provide for a more efficient workflow. Furthermore, analysis methods created with existing HPLC systems, including non-Shimadzu systems, can be easily migrated to the i-Series. The i-Series is ideal for a variety of analysis workflows, including R&D, quality control and safety testing, in fields such as pharmaceuticals, chemicals, food and environmental. ]]> https://biospectrumindia.com/news/97/3419/now-investigators-not-permitted-more-than-3-trials-at-a-time-.html https://biospectrumindia.com/news/97/3419/now-investigators-not-permitted-more-than-3-trials-at-a-time-.html Fri, 11 Jul 2014 16:23:00 +0530 The ministry of health and family welfare, government of India has constituted an expert commitee under the chairmanship of Prof. Ranjit Roy Chaudhury to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. The expert commitee submitted its report with recommendations to the ministry. Subsequently, the ministry decided on the action points. The implementation of the report's suggestions include taking in to account the nature of clinical trials and facilities by an investigator for the number of trials conducted by him/her. The order clearly says that under any circumstances, the number of trials shall not exceed three at a time.  The order shall be binding on the sponsors and and clinical trial applicants for ensuring that trials are limited to three in all scenarios.  ]]> https://biospectrumindia.com/news/97/5299/csa-to-set-up-first-testing-and-certification-lab-in-india.html https://biospectrumindia.com/news/97/5299/csa-to-set-up-first-testing-and-certification-lab-in-india.html Wed, 09 Jul 2014 12:07:09 +0530 The new laboratory will provide testing and certification for medical and healthcare, industrial control products, automation, information technology, audio video technology products, appliances and control equipment to ensure safety, quality and high performance. The company is among the top 10 testing and certification organizations globally. While it is keen to offer these new norms to India, it is hoping that the central government would enforce regulations in the medical devices and healthcare space. India has become a hub for third-party inspection services. The company is also in discussion with the Bureau of Indian Standards (BIS) to look into mutal areas of collaboration and help leverage global standards. It is also keen to grow its operations in India via organic and inorganic routes. "The company has seen its India entry as most appropriate, going by the large presence of medical device companies seeking compliance from global regulators. It makes more business sense to set up a base in India at a time when the market is brimming with positive growth prospects. Therefore, we see India as a market with long-term growth potential", said Mr Ash Sahl, president and chief executive officer, CSA Group. "Our lab in India is envisaged to give a fillip to medical device compliance as a one-stop location for global regulatory adherences, components acceptability, compliance mechanism and safety. Further, with a faster turnaround, manufacturers would be able to considerably reduce the time-to market, said Mr Saibal l Mukhopadhaya, country manager, CSA Group.   ]]> https://biospectrumindia.com/news/97/4289/rules-set-for-ethnicity-as-criteria-to-new-drug-approvals.html https://biospectrumindia.com/news/97/4289/rules-set-for-ethnicity-as-criteria-to-new-drug-approvals.html Wed, 09 Jul 2014 11:15:02 +0530 Ethnicity surely has more to it than being a part of a culture and nation. It might save your life in case the drugs that undergo trials are tested on your ethinic traits and their reaction is recorded at an appropriate time. Earlier, the question of ethnicity was much debated but the guidelines were not visible.  The order no. 12-01/14 DC-Pt-47 issued on July 3, 2014 from Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services (DGHS), ministry of health and family welfare, cleared the air on the issue. It is based on the recommendations of the expert commitee appointed earlier, under the chairmanship of Prof Ranjit Roy Chaudhury. The commitee had submitted its report to the ministry with the actions proposed to be taken and after finalization, the recommendations have been considered for further implementation.  As per the order there are certain ethinic factors that are to be considered, which may be sensitive to some properties of a drug. Among these, ten properties to be considered are non linear pharmacokinetics; steep pharmaco dynamic curve, a narrow therapeutic dose range; highly metabolized drugs, especially through a single pathway, thereby leading to drug-drug interactions; metabolism by enzymes known to show genetic polymorphism; administration as prodrug, with the potential for ethnically variable enzymatic conversion; high inter-subject variation in bioavailability;low bioavailability, thus more susceptible to dietary absorption effects; high likelihood of use in a setting of multiple co-medication and also high likelihood of inappropriate use e.g analgesics and tranquillizers. Besides the above, there has been a clear outlining of factors to determine whether the available data could be ethinically insensitive or sensitive. Definition of a disease and diagnosis of the patient; choice of control group, method of assesment-similarity of medical practice to country of origin; duration of trial; regional medical practice are a few other criteria.      The order gains significance as there was a lack of clarity on the subject and clinical trial companies had no guidelines to follow. NDAC experts have been advised to take into consideration the above factors, while evaluating approvals for new drugs.    ]]> https://biospectrumindia.com/news/97/3605/hp-narayana-health-to-set-up-ehealth-centers-in-india.html https://biospectrumindia.com/news/97/3605/hp-narayana-health-to-set-up-ehealth-centers-in-india.html Thu, 03 Jul 2014 14:48:47 +0530 HP's cloud-enabled solutions, eHealth centers are rapidly deployable facilities built to connect patients in remote areas, to receive consultations and diagnoses from physicians and specialists, HP senior VP and MD (APJ) printing and personal systems Mr Nick Lazaridis said. An EHealth center is customised and fully equipped with cloud-integrated diagnostic equipment, workstations and video conferencing, he added. "We plan to install upto 20 eHealth centers over the next 18-24 months. The equipment and training will be provided by HP," Mr Lazaridis said. The first eHealth Center was established in 2012 in Haryana. There are six eHealth centers operating in India currently. Narayana Health will create awareness and understanding about the program locally through outreach camps, public awareness campaigns and healthcare education program. HP and NH will also launch three new health hub support centers to serve the eHealth center network. These will provide a facility where staff can get support on technical and medical issues related to operations. "Our goal is to provide high quality healthcare on a large scale to people," said Dr Ashutosh Raghuvanshi, vice chairman and CEO, Narayana Health. He added, "Partnering with an innovation partner leader like HP allows us to leverage technologies, such as telemedicine and cloud capabilities, to accelerate our goal of reaching more people and delivering early detection and diagnosis to patients, while maintaining manageable costs."   HP India country manager Ms Neelam Dhawan said HP's cloud-enabled technology, which is central to eHealth centers, is helping change the dynamics of the healthcare system in India.   ]]> https://biospectrumindia.com/news/97/6585/72-indians-depend-on-medical-devices-to-improve-quality-of-life.html https://biospectrumindia.com/news/97/6585/72-indians-depend-on-medical-devices-to-improve-quality-of-life.html Wed, 02 Jul 2014 13:18:06 +0530 The survey demonstrated that an overwhelming 72 percent of respondents use medical devices, and that around 60 percent of Indians have some such device implanted in them surgically, like pacemakers, stents, orthopedic implants, among others. A matter of concern, though, is that out of the 72 percent consumers, a shocking 89 percent are not fully aware of these devices. "Our survey suggests that people in India don't know enough about medical devices but want to know more. It is quite astounding that 60 percent of respondents think that medical devices are the same as pharmaceuticals," said Mr Sanjay Banerjee, MD of Zimmer India, and Chair of the AdvaMed India working Group. The survey also pointed out that although India is a price-conscious market, quality is an important consideration among the country's growing middle class. It showed that 75 percent of respondents believe that the quality of a medical device is important because safety of patient is paramount. 72 percent of respondents believe that using a high-quality device would help them avoid costs of repeated hospitalization. Ms Abby Pratt, VP, AdvaMed commented, "Unlike in the case of many other products in India where people unequivocally choose the cheapest option, this survey suggests that when it comes to advanced medical devices, quality becomes important because of its correlation to safety. It is noteworthy that 80 percent of respondents see a correlation between brand name and quality."   As per the survey, there is a major gap between medical devices currently being used and what is required to address public health needs. AdvaMed has submitted a letter to the Health Minister, Dr Harsh Varadhan urging collaborative discussions that will facilitate speedy consideration of the bill. Ms Pratt said, "We believe that Dr Vardhan's expertise as a surgeon and health administrator will enable him to appreciate the significance of the medical device industry and its challenges. We are eager to fully participate in India's effort to improve quality of life for patients and look forward to every opportunity the government might provide towards harmonizing regulations for the industry."   ]]> https://biospectrumindia.com/news/97/4396/tpg-to-buy-surgical-equipment-company-suture.html https://biospectrumindia.com/news/97/4396/tpg-to-buy-surgical-equipment-company-suture.html Tue, 01 Jul 2014 15:26:14 +0530 Sutres, the Bangalore-based company, manufactures products like absorbable and non-absorbable sutures, eyeless needles, surgical meshes and disposable gloves. It has an installed annual capacity to produce 20 million sterile sutures at its Bangalore plant. Sutures India also exports its products to more than 90 countries globally. Its annual revenue is estimated at $53 million. TPG has ambitions of making it as a large medical devices company, adding more products like special orthopedic implants and plastic casts. India's healthcare services industry is expanding rapidly, which the global investor is keen on tapping. The acquisition promises to be a boon for the fast-growing domestic surgical equipment market, which is in need of capital to boost technology and market penetration.   ]]> https://biospectrumindia.com/news/97/4001/anomolies-marring-growth-of-medical-devices-industry.html https://biospectrumindia.com/news/97/4001/anomolies-marring-growth-of-medical-devices-industry.html Fri, 27 Jun 2014 14:16:00 +0530 A study titled 'Access to Healthcare: Indian Perspective,' released by The Associated Chambers of Commerce and Industry of India (Assocham) highlighted that India's $3.5 billion worth medical device industry is facing severe challenges because of inadequate quality standards, coupled with huge reliance on imports, time delays and other related hassles. This is resulting in hindrance for new product development, making the industry non-viable and non-lucrative. Unfavourable duty structure for imports and exports is another significant barrier in the growth of the domestic medical devices' industry. Higher import duties for raw materials than finished goods has established an 'import-export anomaly' whereby devices manufactured in India become expensive, due to the high raw material costs making them incompetent against low priced Chinese goods, the study pointed out. "Unlike China, our country does not provide any incentives for setting up medical device production bases. The government should encourage medical device manufacturing, as some significant steps are imperative to boost the domestic medical device industry to reduce our dependence on exports," said Mr D S Rawat, secretary general, Assocham while releasing the findings of the chamber's study. "There is an urgent need for a single window clearance system to spur growth in new product development. The limitations of medical devices, falling under the preview of the Drugs and Cosmetics Act, 1940 has been a major deterrent in the medical devices' sector growth," said Mr Rawat. "Low research and development (R&D) spends, lack of innovation, promotion including low medical device funding from thr Department of Science and Technology under the Department of Biotechnology, inadequate quality standards and others are the significant challenges faced by the industry," he further added. Due to huge cost pressures and competition from China and Asia-Pacific countries, Indian companies have started transitioning up the value chain into the 'medium technology' segment, highlighted the study. "This augurs well for medical devices' future in India as this would imply technology innovation and high margin product portfolio and the 'high value' space would still be governed by MNCs and these products would be primarily imported into India", stated the study.   ]]> https://biospectrumindia.com/news/97/4146/agilent-launches-new-triple-quadrupole-mass-spectrometer.html https://biospectrumindia.com/news/97/4146/agilent-launches-new-triple-quadrupole-mass-spectrometer.html Fri, 27 Jun 2014 13:03:03 +0530 Agilent Technologies has introduced a new flagship triple quadrupole mass spectrometer for LC/MS applications which requires highest sensitivity and robustness. The Agilent 6495 LC/MS Triple Quadrupole system is fully integrated with Agilent's 1200 series UHPLC systems to deliver turnkey performance. The newest addition to the 6400 LC/MS Triple Quadrupole Series, the 6495 is designed for both routine laboratory analysis and for the most challenging quantitation in lifesciences, food and environmental applications. "We are pleased to introduce this premium product into our 6400 portfolio," said  Mr Lester Taylor, director of Agilent's LC/MS product marketing.  He added, "It provides laboratories with a new standard of sensitivity, robustness and reliability for all types of quantitative analysis." Agilent's 6495 LC/MS Triple Quadrupole system is a high-performance instrument that supports quantitative analysis for various challenging applications. Environmental and food science laboratories can use it to screen, identify and quantitate multiple pesticide residues. Pharmaceutical researchers can use it for rigorous drug and protein quantitation. The system is designed for easy setup and operation, requires less maintenance and downtime than other LC/MS instruments. It will increase productivity and streamline laboratory workflow by providing highest-quality results at rapid, UHPLC-speed. ]]> https://biospectrumindia.com/interviews/97/3044/it-will-reposition-healthcare-in-years-to-come.html https://biospectrumindia.com/interviews/97/3044/it-will-reposition-healthcare-in-years-to-come.html Mon, 23 Jun 2014 10:44:00 +0530 1. Can you please provide us some statistics that will highlight how the healthcare sector has changed over the years? It's interesting to attribute to the fact that currently at $128 billion, healthcare is one of the fastest growing industries in the country, with a CAGR of 15 percent. The government of India has planned an increase in healthcare related expenditure from an estimated 1.4 percent of GDP in 2011/2012 to 2.5 percent by 2017. Simultaneously, India's middle class is fueling growth in the healthcare private sector. Increasing awareness and affordability is pushing healthcare providers to attain better quality outcomes and adopt standards to create a unique experience for the patient. 2. How has India managed to use IT in its healthcare services? If we see, over the years lot of things has changed in India. Transformation is in progress. The Government has proactively spent a lot of money and in response to this, every state has taken initiatives to avail IT services in healthcare sector. However in India complacent systems were not available in the past but today realizing the push and the demand, huge investment is taking place. Private sector is playing a huge role and almost 80 percent of the investment is done by them and it will continue to grow in future. Changes are happening but our total IT spent is not even 1 percent but we can see this growing in future because of a lot of advancements. 3. Do you believe that if an innovative solution works out in India, it can be implemented anywhere across the globe?   Dell's healthcare strategy centers around our fundamental understanding of customers, combined with deep IT domain capabilities across our infrastructure, cloud, application and business processing outsourcing services. If you see the transformation of the global healthcare market, the focus is shifting from care giver to patient. All the solutions are being built keeping the patient in mind for better outcomes, accessibility and affordability. The Indian healthcare industry is mostly driven by private healthcare and largely paid out-of-pocket. In such a scenario, the patient takes center stage which is also a global emerging trend. In our belief, if the solution is affordable, accessible, faster to implement and quick to adopt, it will work anywhere globally. 4. What are the challenges that exist in the Indian ecosystem because of which IT in healthcare has not been able to flourish? The biggest concern for IT players like us is that healthcare does not consider us an option for solution and innovation. Apart from that, price sensitivity is one of the major barriers. Not only this, there is conflict of opinion among the older generation and younger generation owing to the fact that the younger generation is more aggressively following IT. Applying IT practices in real situation would call for upgrading the knowledge of doctors. 5. Are there any plans to collaborate with the Government of India and change the way healthcare is delivered to the masses? Dell transforms care by connecting people to the right technology and processes, creating information driven healthcare and accelerating innovation. Dell supports the entire spectrum of care delivery: hospitals, health systems, physician practices, health plans and healthcare supply chain organizations. It's an exciting time for us to be part of the Indian healthcare industry. The Indian government has recently taken a number of great initiatives for the betterment of the healthcare industry. One of these are "EHR standards for Indian healthcare sector" where Dell participated as a member of FICCI committee in the process of finalizing guidelines. We think this is a great step towards the way healthcare will be delivered. We have been evaluating a few opportunities from central and state government bodies to understand their requirements and terms and conditions. We are looking forward to work with government bodies as soon as we complete the evaluation.   6. What future projects does Dell have in the pipeline? The need of the hour for the current Indian healthcare market is to reduce complexity through integration, creation of a unique patient experience, addressing patient mobility and bringing standardization by adopting seamless automated workflows to ease the pressure on care providers with all around accessibility. As mentioned earlier, currently Dell is committed to bringing business transformation with affordable cutting edge technology to healthcare providers that can help them increase productivity and efficiency. The hospital-in-a-box solution is such an initiative, we just announced, that seamlessly and cost effectively delivers integrated clinical and financial systems for healthcare providers in India. The solution is truly one of a kind in terms of its capabilities, delivery model and pricing. We believe it will be a game changer for the Indian healthcare provider market where hospitals are constrained by huge upfront capital investments, and higher cost of licensing, maintenance and support. We will continue to bring to India unique solutions that will allow healthcare providers to focus on their number one goal -- enhanced patient care. Being global leaders, as rated by Gartner and Everest, we will continue to invest in building our global pipeline.   ]]> https://biospectrumindia.com/news/97/5375/merck-unveils-solid-dose-formulation-lab.html https://biospectrumindia.com/news/97/5375/merck-unveils-solid-dose-formulation-lab.html Thu, 19 Jun 2014 17:34:00 +0530 According to Merck's press release, the facilities at the lab were built to provide services and application assistance to the pharmaceutical industry, for classic pharmaceutical clients working on solid dose formulations. In his inaugural remarks, Dr Claus-Dieter Boedecker, MD and head, Merck Millipore India, highlighted the need for the new facility. "India is one of the largest exporters of pharmaceutical products to North America and the European region. Between 2009 and 2013, exports from India registered an average growth of 24 percent; almost unaffected by the overall economic situation. India also has the highest number of US FDA approved facilities outside the US, of which, most have approvals from authorities in Europe, Canada and Australia." "The quality standards achieved by Indian pharmaceutical companies, however, have been overshadowed by the recent spate of quality concerns. These could adversely affect export performance going forward. Additionally, speed is of essence in the field of generics. With the new facility, Merck intends to deliver on both these parameters. Created with the needs of the industry in mind, the facilities provide service and application assistance to those working in solid dosage formulation," he opined further. Merck's objective of setting up the Lab is primarily to assist clients, using advanced excipients from the Merck Millipore portfolio, with pre-formulation studies. Mr Benoit Gourdier, head of sales, Asia, Process Solutions, summarized the lab's purpose,   He said, "The new formulation lab greatly reduces costs and helps build in-house capability. The adage, 'Time is Money', has never been more relevant than when speaking of the generic pharma industry. By setting up the formulation lab, Merck Millipore intends to sharpen its clients' competitive edge by providing faster solutions to formulation design problems thereby reducing costs." Additionally, the lab will offer the possibility of inviting clients for hands-on training sessions and demonstrations of new technologies in solid dose formulation. The formulation lab is expected to engage in a continuous exchange of technologies and experts from Merck Millipore sites across the world to bring the latest developments in excipients and technology to formulation scientists in India. Mr Peter Salazar, head, Pharm Chemicals Solutions, Merck Millipore India, gave an overview of the capabilities of the new formulation lab. He explained, "A large number of active drugs have problems of low solubility and low permeability. Incidentally, the majority of active ingredients under development have the same problems. These are, therefore, not only difficult to formulate, but in the absence of an appropriate technology, need to be used in high concentrations in order to be effective. Merck Millipore offers a range of solutions for these bioavailability issues through the formulation lab." "With the new facilities at the lab, Merck Millipore hopes to add value to its customers by providing alternatives to customers for new application fields. Enhanced product performance studies and comparison studies can now be conducted at the lab. We will also offer hands-on training to clients in specific areas of application," he concluded. ]]> https://biospectrumindia.com/news/97/3830/new-pipette-to-reduce-repetition-and-save-time.html https://biospectrumindia.com/news/97/3830/new-pipette-to-reduce-repetition-and-save-time.html Tue, 17 Jun 2014 15:09:00 +0530 "Scientists working in liquid handling and sample preparation need pipettes they can trust," said Mr Raymond Mercier, business director, liquid transfer, Thermo Fisher Scientific. According to the company's press release, this new electronic pipette is designed to maintain precise sample volumes on every channel with fewer repetitions and reproducible results for multiple application types. "The Thermo Scientific E1-ClipTip electronic pipette's interlocking technology provides outstanding sample security and makes pipetting more efficient with the ability to transfer samples quickly between different labware formats using the same pipette throughout the protocol," added Mr Mercier. ]]> https://biospectrumindia.com/features/97/6244/new-government-indias-leading-biotech-voices-speak.html https://biospectrumindia.com/features/97/6244/new-government-indias-leading-biotech-voices-speak.html Tue, 17 Jun 2014 12:27:00 +0530 With the new government in place in the country now, expectations are soaring high across various industry segments. Industry experts and stalwarts are keeping a keen watch on every move the new government is making to keep its promises. The nation's Biotechnology sector, neither, is an exception. With unresolved and long-pending turmoil and hurdles over regulations, investments, and clinical trials, the industry is fully geared, pinning its hope on the new government. But then, there are industrialists who believe that the government alone cannot solve the industry's crises. According to Dr G S Krishnan, regional president-India, Novozymes South Asia, areas like regulatory, biodiversity and environmental concerns require serious fillip and revamp to witness giant leaps in business opportunities. "The Industry needs decision makers to support the industry's development with faster approval process, if we have to be on par with the other developing world. It is definitely BT after the IT boom, which will also be the key to India's economic growth which is far more sustainable," he added.   This new government is also expected to prioritize overall support to the biotech segment helping India compete with the global markets by playing a leadership role. Dr Krishnan also opined that the government can play a pivotal role in supporting key traditional polluting industries for faster adoption of sustainable biotech solutions and by enforcing environment regulations which are already in place, thereby sustaining the economy in the long run. "It is also imperative that a special committee is set up to address biofuel segment development in the interest of reducing dependence through oil imports in line with the rest of the world, and reducing our current account deficit significantly. We can take advantage of the abundant agricultural residues available in this country. They can be put to better use and evolve a policy which will support inclusive growth, supporting farmers and also generate employment in rural areas," he commented. Then there are others who want reduced interest rates on borrowed capital, creating a climate for investment in the segment. Said Dr Ajay Bhardwaj, CEO, Anthem Biosciences, "It is important to remove the stigma of India being a difficult place for getting simple things done. Also, reduction in rampant corruption in government agencies is crucial for development. In fact, it is a daunting task to deal with government. Making land and buildings reserved for biotechnology industries at affordable rates is much needed. The lobbying ability of Biotechnology enterprises with the government is limited. We are still at the margins. ABLE needs to get more diversified and professional to take up the challenge of representing this nascent industry."   Dr Bhardwaj also wants the new government to treat investments in biotech on par with the IT sector. "The IT sector has innumerable duties and tax exemptions compared to biotech. It is important to open doors for international investments in biotechnology. This technology has to be embraced and not feared. However, misguided and misinformed NGOs hold too much sway over policy," he commented. Post election results, on May 17, 2014, Dr Kiran Mazumdar-Shaw, CMD, Biocon, in her blog, under the title, 'Reviving the Indian Growth Story', wrote, "If the new government is serious about delivering on its promise of a better life for every single Indian, its No. 1 priority should be to navigate the country towards a path of sustainable and inclusive economic growth. The new government that comes to power will have to move quickly to de-bottleneck projects and revive investment sentiment in the country. India desperately needs to be seen taking corrective actions to regain its lost glory by creating an enabling ecosystem that paves the way for a double digit growth." According to her, the new government needs to take critical steps to revive the Indian economy through smarter regulations for ease of doing business, efficient taxation system, removing bottlenecks for boosting the flow of foreign capital, generating high-skilled jobs, introduction of universal healthcare program and focusing on science and technology, and incentivizing innovation. Dr Mazumdar-Shaw also wrote, "There is no scope for complacency as significant challenges face the country. Projects worth over $100 billion were shelved or abandoned in FY14, the highest in the past 18 years, due to policy uncertainty and pending regulatory clearances, according to CMIE." Avesthagen's founder and CMD, Dr Villoo Morawala Patell, sums up her expectations in just one line. "It is funding, funding and funding, and allowing R&D companies to list on the stock market."   For some of them, the existing confusion over clinical trials regulation in the country seems to be a mammoth burden that the new government mandatorily needs to solve immediately. Dr Jagadish Mittur, head, Biotech Facilitation Cell in KBITS, Department of IT, BT and S&T, Government of Karnataka, expressed, "We need an atmosphere of fearlessness in supporting innovation and creativity. Lack of large capitals and coordination in prioritized research need to be addressed quickly by the new government. There should also be accountability in place on research spending. Most of all, the commotion over the requirement of GM technologies to solve India's hunger, malnourishment and farmers issue has to be resolved." Hyderabad-based Indian Immunologicals' deputy managing director Dr K Anand Kumar said that streamlining the regulatory approval process for vaccines is crucial, since the current situation takes four long years for human vaccine approvals and six years for veterinary vaccines. He sees clearing infrastructure bottlenecks, especially the lack of power availability as an important part of manufacturing vaccines. "Ironically, life-saving vaccine units face power cuts in Andhra Pradesh, whereas IT companies are exempt," he lamented. "The new government has to simplify the approval process for clinical trials without compromising on quality, safety and efficacy. Countries like the US and the UK have a separate regulatory body for veterinary products. India should adopt that. It is significant to provide incentives for both research and capital investments in the biotechnology sector," concluded Dr Kumar.   Dr V S Ravindran, CEO, Caprienzymes, strongly feels that the younger generation need to be given the right platform for the growth of the industry. "Young-blooded entrepreneurs and start-ups in the country should be provided the right physical space in technology parks at subsidized rates. The new government needs to realize the importance of technology transfer and joint ventures along with industrial partnerships with academia and institutions. R&D activities desperately need support and transparency. In India, marine biotechnology needs much more attention, and the usage of chemical pesticides should be substituted by organic fertilizers and manures." For many experts in the industry, 'regulation' seems to be on top of the mind which requires immediate attention.According to Ms Mahima Datla, the currently regulation related to new drugs is fragmented and spread across many ministries. "A restructuring of the CDSCO along with a consolidation between regulations related to food, GMO's and drugs needs to be seriously contemplated. There are many successful examples of this structure in most parts of the world. Building technical competence within such a consolidated structure would be equally important," she adds. She also feels that another issue that needs more immediate attention is clinical trials.   "Clinical research is an absolutely critical step in the process of validating new drugs efficacy and safety and as such initiatives that raise the bar in terms of improving the quality of clinical research being conducted is welcome. At the same time, it is imperative that regulation in this area be streamlined and be formed in the context of encouraging innovation to occur. Our current regulations are counter-productive, not just for innovation but for affordability and access," says Ms Datla. In the specific context of immunization, Ms Datla emphasizes the need to build on the success the country has demonstrated in Polio control, and focus on increasing the coverage of existing vaccines, and ensuring that children do not die from vaccine preventable diseases. "Increasing the spend on health and reversing the alarming trend of reduction in budget allocations for immunization will need to be addressed in order to strengthen health systems and delivery and reduce childhood mortality," Ms Datla opines. Some countries benefit from the fact that they have push-mechanisms, to stimulate innovation. Examples of this is where the governments invest significantly in research and innovation, thus having a robust pipeline emerging from academia and research institutes. "In India, funding of scientific institutions has not translated to innovation and applicable health interventions, and we largely rely on innovation from external scientific institutions or industry," she continues. "Therefore, in the context of our country, mechanisms that generate demand for products and services, healthy policies related to FDI, pricing, and taxation have immediate relevance in stimulating innovation and investments in the biotech industry and these are the ones I hope the new government focuses on in order to facilitate growth." According to Dr Mallik Sundaram, CEO & president, Mitra Biotech, the new government needs to form transparent policies regulations to create a friendly start-up environment to bring path-breaking technologies to the forefront.   "It is important to create and retain human capital which would be an asset. And developing a pipeline through premier educational institutions is crucial. It is also imperative to create an ecosystem conducive for funding through grants or investors for research and commercialization," commented Dr Sundaram. He believes that creating a stringent framework to maintain optimal utilization of funds, and accountability by recipients should be made mandatory. "Promoting working with educational institutions to encourage internships and update curriculum with recent advancements, leveraging more public-private partnerships and eliminating unnecessary red-tapism should be considered as pivotal tasks by the new government," ended Dr Sundaram. Speaking for the Agri-biotech industry, Dr K K Narayanan, MD, Metahelix Life Sciences, said, "Regular functioning of GEAC and its sub-committees should be re-initiated. All the back-log of applications for GM crop trials or studies and commercialization should be disposed-off as soon as possible. It is significant to frame a clear policy regarding GM food crops which need to be allowed in the country. Also, the centre-state policy coordination mechanism needs to be made more effective." Dr Narayanan also emphasized that the State-level NOC requirements for conducting field trials needs to be dispensed with. "The BRAI bill needs to be re-introduced after appropriate modifications," he added.   He also suggests that the new government initiate and launch a public outreach program to promote the correct understanding of biotechnology in agriculture to dispel misinformation and promote better understanding among the public at large. "The government's subsidy should also be targeted at improving the adoption of new and productivity enhancing technologies that augment farmer's income," Dr Narayanan expressed. "The new government seems to be keen on knowing the challenges, and is already taking measures to interact with all stakeholders. The industry organization, ABLE, can interact with the people concerned and also make formal representations, which I believe is already underway," he concluded. ]]> https://biospectrumindia.com/news/97/7888/apples-iwatch-to-be-launched-in-october.html https://biospectrumindia.com/news/97/7888/apples-iwatch-to-be-launched-in-october.html Wed, 11 Jun 2014 10:24:45 +0530 The publication cites industry sources to report that specs for the new product are being finalized. As per the reports device will sport a curved organic light-emitting diode (OLED) touchscreen and collect health-related data, including calorie consumption, sleep activity, blood glucose and blood oxygen levels. The watch will also allow users to receive notifications from their phone. Nikkei also cites suppliers and add that Apple plans to sell about 3-5 million units every month. The publication further claimed that Apple will partner with Nike to integrate their services. Nikkei has a good track record of predicting launch dates for Apple devices but it's not the first time these rumours are being heard. Earlier, China Times had reported that Apple has ordered the production of 3-4 million units of the iWatch for the second quarter, while it will increase the order to 14-15 million in the third quarter and that the device will hit the market in the second half of 2014. During Apple Worldwide Developers Conference keynote, Apple had announced a new Health app that gives users a clear overview of their health and fitness data, all in one place. The Health app gathers information that users choose from their various health apps and fitness devices, and provides a clear, consolidated overview in one place. iOS 8 offers developers the ability to get health and fitness apps to communicate with each other. So, it is very likely that Apple may launch a health-centric device along with the new iPhone in the fall.   ]]> https://biospectrumindia.com/news/97/4927/thermo-fisher-inaugurates-its-customer-experience-center-cec.html https://biospectrumindia.com/news/97/4927/thermo-fisher-inaugurates-its-customer-experience-center-cec.html Tue, 10 Jun 2014 16:57:14 +0530 Speaking exclusively to BioSpectrum, Dr Joydeep Goswami, president, APAC and Japan, Life Sciences Solutions, Thermo Fisher, said, "A lot of our technologies are cutting-edge. Most customers are unfamiliar with various new technologies. Hence, before investing in any kind of technology, customers want to get comfortable with it. Our CEC will enable customers to experience and educate themselves in instruments and technologies, thereby enabling them to learn to solve their issues. The CEC will enable us to provide hands-on experience and training in our latest technologies." According to the company's press release, the CEC is staffed by 40 scientists. Mr Devashish Ohri, MD South-Asia, Life Sciences Solutions, Thermo Fisher, commented, "Biotechnology is a new industry. Investing in any kind of technology can prove to be expensive most of the time. So our customers want to try the actual technology before buying it. Through the CEC, customers can use the technology." About 24 training programs are scheduled at CEC this year, aiming to enhance the skills and knowledge of over 200 scientists. Mr Amit Chopra, VP & GM, Thermo Fisher India, said, "The primary objective of this one of its kind facility is to create awareness about the most recent technologies and to reinforce our allegiance to the scientific community. We look forward to serve and to collaborate with our customers to democratize and advance biotechnology in this country to enable our customers to make the world healthier, cleaner and safer." ]]> https://biospectrumindia.com/news/97/5777/phenomenex-extends-its-lux-chiral-bulk-media-line-.html https://biospectrumindia.com/news/97/5777/phenomenex-extends-its-lux-chiral-bulk-media-line-.html Tue, 10 Jun 2014 15:15:30 +0530 A global leader in advanced technologies for separation sciences, Phenomenex has announced the extension of its successful Lux chiral bulk media line to meet the needs of preparative chromatography and batch chromatography applications. The Lux Cellulose-3 and Cellulose-4, unique and complementary chiral stationary phases, are now available in 10 µm sized particles. The compact packing increases efficiency and enables the usage of shorter columns over the previous 20 µm sized particles. The two new phases join existing purification media options of Cellulose-1 and Cellulose-2, providing a dependable, high-resolution screening set with a wide range of selectivity. All four 10 µm cellulose chiral phases benefit from Phenomenex's unique manufacturing process and silica coating technology. The new cellulose phases, especially the cellulose-3 offers unique chiral recognition abilities to provide enantio-separation when other phases fail. It uses the Cellulose tris (4-methylbenzoate) as the chiral selector, a variant cellulose ester derivative. Each of the four phases use varied chiral selectors providing special chiral recognition abilities that complement the Lux family of columns. The 20 µm particle size particles are still available for customers using simulated moving bed (SMB) technology. "The successful resolution of chiral compounds requires more than one stationary phase and the more phases you have to choose from, the better your chances of resolving enantiomers," explained Dr Marc Jacob, product manager, Phenomenex. "Our entire line of Lux media have been very successful in resolving hundreds of enantiomers and we are pleased to expand our product offering to meet the demanding needs of preparative chromatography applications," he further said. ]]> https://biospectrumindia.com/news/97/1480/waters-receives-cfda-nod-for-new-device.html https://biospectrumindia.com/news/97/1480/waters-receives-cfda-nod-for-new-device.html Fri, 06 Jun 2014 13:38:06 +0530 In a latest statement, Waters Corporation announced that the Chinese Food and Drug Administration (CFDA) has provided its approval for the registration of its new device. Waters' will now go ahead with the legal promotion and sales of ACQUITY UPLC TQD system which is a medical device for routine diagnostic applications and neonatal metabolites diseases screening. In a bid to grow clinical LC-MS applications worldwide, this registration, the company said represents the second Waters' mass spectrometer approved for in-vitro diagnostic (IVD) applications in China. The company added in its statement that in 2008, the CFDA had approved a neonatal screening solution inclusive of the Waters Quattro micro mass spectrometer. "The approval by the CFDA of ACQUITY UPLC MS/MS system as a medical device is significant for two reasons. First and most importantly, this registration opens the door for millions of Chinese citizens to benefit from the gold standard of LC-MS diagnostic analysis," explained Dr Rohit Khanna, vice president of Worldwide Marketing and Informatics in the statement. He further added, "Secondly, this commitment to China's analytical scientists and laboratories reinforces Waters' strategy of expanding applications of our core chromatography and mass spectrometry technologies throughout the world. As of this decision by the CFDA, the ACQUITY UPLC, MS/MS system is registered as a medical device in 29 countries plus the European Economic Area, which includes an additional 30 countries." An UltraPerformance LC/tandem quadrupole mass spectrometry (UPLC/MS/MS) system, the ACQUITY UPLC TQD is a benchtop, ultra-compact, tandem-quadrupole, mass detector-based system designed for routine UPLC/MS/MS analyses and quantitative applications featuring high levels of MS selectivity, robustness, speed, and accuracy. ]]> https://biospectrumindia.com/news/97/4448/first-optical-sensor-to-measure-oxygen-in-cells-.html https://biospectrumindia.com/news/97/4448/first-optical-sensor-to-measure-oxygen-in-cells-.html Fri, 06 Jun 2014 12:41:02 +0530 A latest innovation launched by a German Biotechnology company now makes it possible to measure the real oxygen concentration directly inside the petri dish. The optical sensor developed by ibidi GmbH determines the correct O2 content, which is a critical factor in maintaining the natural behavior of cells in culture. Oxygen sensitive beads, or nanoparticle reagents, are used in combination with the ibidi OPAL System. By identifying changes in the fluorescence lifetime of these particles, the oxygen concentration in the immediate neighborhood, or directly inside the cells, can be determined. "We are very excited to bring this innovative new technology into the market," said Dr Roman Zantl, president, ibidi GmbH. "We, along with Colibri Photonics, want to advance the knowledge of oxygen conditions in cell culture, because this is a crucial factor in cancer treatment," he added.   This original technology is an invaluable tool for mimicking the conditions of real tissue in in-vitro experiments. For the first time, extra and intracellular O2 concentrations in cells and tissues can be quickly determined in just a few seconds with the ibidi OPAL System. Subsequently, cell culture conditions can be adapted to the real conditions in tissues. In contrast to existing technologies, the OPAL measurement is non-invasive and occurs in real time, making it ideal for in-vitro hypoxia conditions, such as 3D cultures, spheroid models, and tissues. The OPAL technology was developed by ibidi's cooperative partner, Colibri Photonics, from Potsdam, Germany, and is now being marketed by ibidi GmbH. Cells will only behave naturally when they are cultured under the specific conditions of their biological environment. In mammals, the most prominent conditions are temperature, pH, O2 and CO2 concentration, and constant concentrations of salts and nutrients.   In order to achieve biologically relevant results, it is crucial to maintain these conditions on the microscope stage during live cell imaging experiments. In addition to controlling the oxygen concentration in the stage top incubator, it is indispensable to know the real oxygen concentration near the cells, or even inside the cells. Since cells consume oxygen, the concentrations are typically much lower in cell clusters, such as tissue or spheroids. ]]> https://biospectrumindia.com/features/97/5507/research-yet-to-unleash-nano-applications-in-biosciences.html https://biospectrumindia.com/features/97/5507/research-yet-to-unleash-nano-applications-in-biosciences.html Fri, 06 Jun 2014 10:41:57 +0530 Nanobiotechnology is an interdisciplinary field which cannot be ignored at any point in the biotech industrial sector. It has contributed more importance in converting research into applications, especially drug delivery system and drug discovery process. Surveillance report in the recent past shows that several consumer products with the application of nanotechnology are not yet found majorly in biotechnological products. More research is require to unleash nano applications in biological sciences, and hence there is less contribution by the Indian industry who have so far lead the biotech market.  Product research in nanobiotechnology is carried by very few Indian lifescience companies which is alarming signal to all their comrades.   Says Mr Baskar Viswanathan, director of research, BioLim Biosolutions, "Queries and demands in the existing biotechnology market have set immense potential to describe the opportunities in nanobiotechnology sector. The key role played by the nano materials in the biotech products are widely followed by western countries. Hence the market achievement is huge and the opportunities it floods in to the biotech market will inclusively set new trends in our biotech commodities." Western cultures are more and more branded with the buzz word 'nano' in the consumer products, for instance, microelectronics, cosmetics, pharmaceutics and food industries. Our biotech market ratio are predominantly lead by the pharma sector in terms of biosimilars, and its drug delivery process. "Revolution can be brought into the pharma market if it can overcome several drawbacks in the drug delivery process," comments Mr Viswanathan. "Whereas, drug delivery process was ultimately determining the overall consequence of the administered drug. Huge opportunities are opening up for latest practices in nano-enabled machines and vehicles for drug administration with patient compliance,'' he further added. Environmental pollution is still an unraveled area where research demand is put forth hugely for biotech industries, whereby the nano materials it can constructively decrease pollutants. Hence, there is a big market share to be played by the nanobiotechnology products.   "However, lack of public awareness in identifying nano products is another reason for trailing inputs in the nano sector. Few healthcare, especially, cosmetic products are being released in markets with the involvement of nanotechnology, which is gathering less attraction in the crowd," explains Dr Viswanathan. Mr Viswanathan feels that nanotechnology can work with any object making it better than how it was previously. "There are several examples which can be mentioned in areas like textiles, electronics, cosmetics, pharmaceutics and food. Nanotechnology has become, apparently, applicable in all these areas especially, skin lotion creams to protect from UV sun light for longer time, stain free fabrics, anti-infection bandages with higher efficiency, accurate pregnancy test kit, anti-microbial water purifiers, and anti-sensitive tooth pastes for preventing dental sensitivity. Nanotechnology has already influenced few other applications in molecular recognition principle in diagnosis as well as drug development process, but yet to reach the consumer products," elucidates Mr Viswanathan. Hence in different perspective nanotechnology can be applied to any field where demands for improvisation exists. ]]> https://biospectrumindia.com/news/97/3644/select-biosciences-to-organize-free-workshop.html https://biospectrumindia.com/news/97/3644/select-biosciences-to-organize-free-workshop.html Tue, 03 Jun 2014 15:30:00 +0530 Select Biosciences India has announced a free workshop on "Mass Spectrometry Solutions for Proteomics and Genomics Research". The workshop is being held in conjunction with "Genomics and Proteomics Research" Conference to be held in New Delhi on June 12-13, 2014. The conference is sponsored by AB SCIEX, a well known biosupplier company, dealing in chromatography products and co-sponsered by Premas Biosciences, the distributor of Illumina's products in India. The workshop will be held at AB SCIEX's Centre of Excellence, Gurgaon, India on June 12, 2014 and is free for delegates of the genomics and proteomics research conference. Apart from the worshop, the conference will focus on advancements in Genomics and Proteomics, especially in the field of gene analysis. This event will offer a definite advantage to the researchers in the fields of human, animal and plant genomics, genomics biomarkers, epigenetics, next-generation sequencing, miRNA and non-coding RNA, qPCR, bioinformatics, proteomics and proteome analysis including chromatography and mass spectroscopy. The program will consist of moderated sessions and engaging an expert panel on research themes at the core of Genomics and Proteomics. Registered delegates will have unrestricted access to all co-located meetings ensuring a comprehensive learning and sharing experience as well as being financially beneficial to attendees. The oral presentations and posters presented in this conference will be published in a special issue of Computational and Structural Biotechnology Journal (ISSN 2001-0370) devoted to Genomics and Proteomics Research. ]]> https://biospectrumindia.com/news/97/3048/roche-introduces-digital-pathology-platform.html https://biospectrumindia.com/news/97/3048/roche-introduces-digital-pathology-platform.html Thu, 29 May 2014 15:40:27 +0530 The Roche Diagnostics platform, which includes the iScan Coreo scanner and the Virtuoso digital pathology software, together represent a new way of working for pathologists in India. They are no longer tied to a microscope and a glass slide, a practice that has existed for more than 200 years. Discussing the new technology at a meeting of pathologists in India, Mr Guido Sander, MD, Roche Diagnostics India, said, "From remotely viewing patient slides, to consulting specialists real time within India or even in other parts of the world, the applications of digital pathology are endless." According to Roche's press release, the scanner provides high speed slide scanning, improved image quality, and advanced slide handling. The scanner is packaged with advanced image viewing software, offering pathologists the ability to view and annotate digital images of scanned slides. Paired with the virtuoso digital pathology software, iScan Coreo provides users with a complete digital pathology solution from image acquisition through customized reporting thus, increasing operational efficiencies and productivity in the lab. Dr Sujay Prasad, director, Anand Diagnostic Laboratory shared his vision on digital pathology while addressing the meeting of Pathologists. He said, "For us, digitization is a tool for improving workflow efficiency in the histopathology laboratory, thus ensuring patient safety. Our priority is traceability and peace of mind." Digital pathology can increase diagnostic confidence, reduce subjectivity and ultimately improve patient care with consistent and reproducible results. This latest advancement will transform the practice and take pathology beyond traditional microscope applications. ]]> https://biospectrumindia.com/features/97/7199/exceptional-service-needed-to-compete.html https://biospectrumindia.com/features/97/7199/exceptional-service-needed-to-compete.html Wed, 28 May 2014 12:46:00 +0530 Here are some of them, describing what they do, their offerings and how they can help Indian companies get a foothold in the UK. "We can help Indian companies understand who is in Cambridge, what research they are doing, including drug discovery, what drugs are in the pipeline, what phases they are in, whether or not they have clinical candidates and so on. Companies in Cambridge are very busy. One thing that we want from the Indian companies is better articulation of their USP, and fortunately Indian companies are able to articulate very quickly," said Ms Jeanette Walker, project director, Cambridge Biomedical Campus. According to Ms Walker, Cambridge companies are very open-minded and are open to innovation. "In the past, companies were doing things on their own through closed innovation. Today, they are outsourcing most of the work to India and China. That gives them two things potentially: cost advantage or savings and the flexibility to turn a service off when the project is over," she added. Ms Walker advises Indian companies to be patient until companies understand the offerings. "Do not expect to get business on the first meeting itself. Indian companies need to have at least one representative office either in UK or Cambridge. This will allow us to manage a relationship since there has to be someone who is available locally. Collaborations in science are no different from personal relationships. They have to be built on loyalty, respect and trust. This cannot be achieved through electronic means only."   Ms Walker emphasized that service is of absolute paramount importance. "Exceptional service is needed if they are going to compete. It is also significant to do everything in a timely fashion and as well as keeping the customer informed about basic things," she said. She sees competition as a major challenge since Cambridge is quite a crowded marketplace. "It is in persuading Cambridge companies that they can deliver on their promises. There is a lot of support in Cambridge in terms of Indian companies setting up their offices. It is easier to find people who can help you with funding, find accommodation, and there are network meetings where you can get integrated in the community easily and quickly. All of this happens within a 20 mile radius. Hence Indian companies become known very easily. If your work is exceptional then those companies will talk about you to other companies in a good manner," she said. There is an element of maturity and longevity in Cambridge, believes Ms Walker, since the Cambridge cluster has a track record.   "Companies have been successful and they are raising funds and doing good licensing deals which give Indian companies a degree of comfort. For example, if you are a service company and you want to expand, there are 220 organizations in this cluster within a 20 mile radius of Cambridge," she expressed. "For any company which has not done any business in Europe can come in to the Cambridge cluster because it is an easy and soft landing for them. They can try their projects in the Cambridge cluster and then move to the rest of UK, and use UK as their platform to go to Germany, France and other countries. It is an easy place to do business for newcomers," concluded Ms Walker.   ]]> https://biospectrumindia.com/news/97/3817/beckman-coulter-gets-ce-mark-for-veris-mdx.html https://biospectrumindia.com/news/97/3817/beckman-coulter-gets-ce-mark-for-veris-mdx.html Fri, 23 May 2014 13:02:00 +0530 Attaining CE Mark on the VERIS MDx System and the VERIS CMV assay are key milestones in the expansion of Beckman Coulter's presence in molecular diagnostics. "After extensive research and development, Beckman Coulter has applied its expertise in diagnostics with our in-depth knowledge of workflow to bring molecular diagnostics to the clinical laboratory," said Mr Richard Creager, senior vice president, Molecular Diagnostics Business Unit, and chief scientific officer at Beckman Coulter Diagnostics. "We have spent tremendous effort on understanding the needs of molecular laboratory professionals to develop a system that simplifies molecular diagnostic testing, while delivering the results that patients and clinicians need." The VERIS MDx System is a fully automated, random access molecular diagnostics system for the quantitative and qualitative analysis of molecular targets from clinical patient specimens. The VERIS system integrates key steps in molecular diagnostics to streamline workflow and system management, while also processing critical STAT samples and ensuring prompt delivery of results. By providing continuous access, one-step loading and individual test reporting, VERIS helps medical laboratory professionals advance and optimize the molecular diagnostics lab, by providing the control and freedom to give the right answer at the right time - for patients and physicians. The VERIS CMV assay is a Polymerase Chain Reaction (PCR) assay designed for the quantitative determination of CMV deoxyribonucleic acid (DNA) from human plasma. When used in conjunction with clinical presentation and other laboratory findings, the VERIS CMV assay aids in monitoring CMV viral load. Beckman Coulter is committed to the ongoing development of assays to expand the VERIS infectious disease portfolio and plans to submit for CE Mark on assays for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) in 2014. ]]> https://biospectrumindia.com/news/97/3815/jamia-bd-introduce-specialized-elearn-course-.html https://biospectrumindia.com/news/97/3815/jamia-bd-introduce-specialized-elearn-course-.html Thu, 22 May 2014 15:22:00 +0530 New Delhi based Jamia Hamdard University and BD Biosciences, a segment of BD (Becton, Dickinson and Company), have announced FACSTM e-LEARN, a joint online learning program in cell research and diagnostics for young scientists and researchers. Commenting on the launch, Dr G N Qazi, vice chancellor, Jamia Hamdard University said, "I am confident that academic programs named as FACSTM eLEARN initiative will be unique blend of theoretical knowledge and handson exposure to the wonderful technique of flow cytometry which has found increasing new applications in the fields of science and medicine." These programs are designed for professionals who are already in a job or a regular academic program. The web module and e-mail support program will be followed by handson experience on Flow Cytometry instruments and applications. "The establishment of the BD-JH FACS Academy at Jamia Humdard in 2012 was an inspiring initiative to our ongoing education and training programs designed to help increase the capacity of young scientists, researchers and clinicians on a sustainable basis. We believe this joint academic program will be integral towards capacity development in Flow Cytometry in India," said Mr Varun Khanna, managing director, BD India. The web based learning course will start from 15 July, 2014 and have a five day contact program inclusive of evaluation and examination will be held between November 17-19 December, 2014.Flow Cytometry has been recognized as one of the important technologies that transformed the face of modern lifescience and biotechnology research in India. Over the past few years, the technology has witnessed continuous improvement and new emerging applications in healthcare research. It scans millions of cells in minimum time and cells of interest can be further tagged with suitable add-ons to study their various characteristics. Flow Cytometry is a count and measure of the physical and chemical characteristics of numerous biological particles such as cells, cell subsets, DNA, surface antigens and bacteria. The training program comes at a time when the demand for training in Flow Cytometry is growing consistently in India. ]]> https://biospectrumindia.com/news/97/5963/virtual-hospital-launches-healthcare-app.html https://biospectrumindia.com/news/97/5963/virtual-hospital-launches-healthcare-app.html Fri, 09 May 2014 12:12:53 +0530 According to the company's press release, a patient only needs to provide important details like solution they seek, medical history, and upload documents if any, and location among others, and Doctree would provide a fine choice of experts suitable for that particular need along with the best prices within 24 hours of the request. "With our new mobile app we are allowing the doctors to make an easy access to the portal and provide instant quotes thus hastening the process and enabling a patient to make an informed choice", says Dr Sreenivasan Narayana, CEO and founder, DocTree. The concept for this web-based service would enable a consumer to search and select healthcare providers via a two-way dynamic online process. "Patients need to play a more proactive role in the choices they make, for which they need rich and transparent information on healthcare availability, accessibility and affordability. We strongly believe that for every patient there is a doctor match available within his or her budgets. There is no way that a patient has to neglect the health due to cost constrains", says Dr Madhav Hegde, director, Medical Services, DocTree. The DocTree mobile app is specifically designed for the medical fraternity who are new to DocTree, as well as those who are on board and are committed to shape up the health care accessibility in the country. "Each one of us prefer convenience without having to compromise on the quality, and apps have been able to bring about this transition easily. With the help of DocTree app, things have been simplified and one can monitor the profile on the portal without having to login. This has reduced the response time to a patient's query drastically, and we can now provide our quotes promptly even when we are on the move after carefully going through the patient details," says Dr Ravishankar HR, senior consultant and laparoscopic surgeon, Bangalore. ]]> https://biospectrumindia.com/news/97/7915/strand-triesta-set-up-center-for-cancer-genomics.html https://biospectrumindia.com/news/97/7915/strand-triesta-set-up-center-for-cancer-genomics.html Thu, 08 May 2014 16:55:00 +0530 The center has been set up with the aim of making genomics based diagnostics effective, accessible and affordable. Triesta Sciences is a unit of HCG (HealthCare Global). Dr B S Ajaikumar, founder & chairman , HCG Enterprise, said "We will now incorporate genomic testing which is personalized and will be the future of cancer care. This will help oncologists in clinical decisions and help our patients receive targeted individualized therapies that will improve diagnosis and prognosis of cancer." He further added, "Through this partnership between Triesta Sciences and Strand Life Sciences we hope to enhance the work done by multi- disciplinary team of eminent and established oncologists. With this HCG joins a select group of advanced cancer care centers." Strand-Triesta will enable the world's largest adoption of genomics-based tumor profiling for HCG patients. HCG will lead the way by adopting the Strand-Triesta advanced cancer diagnostics as a new standard that defines the future of cancer care. Sequencing of tumor using next generation sequencing (NGS) technologies, and thorough analysis of individual patient's DNA variations will help physicians go beyond a 'one-size -fits-all' model of cancer therapy.   Such personalized approaches will improve response rates and effectiveness of targeted, chemo- and radiation therapies. Further, genomic tests can detect hereditary risk in family members of cancer patients. Talking about this partnership, Dr Vijay Chandru, chairman & CEO, Strand Life Sciences said, "Strand is committed to expanding clinical genomics as a new paradigm for clinical decision support. The coming together of HCG, Triesta and Strand will result in achieving a scale of adoption of genomic testing, which is unprecedented even in the West." He concluded by saying, "This scale enables affordability, but more importantly, the more cancer genomes we profile, the deeper the insights about cancer we gain. Deeper insights lead to informed decisions in cancer care."     ]]> https://biospectrumindia.com/news/97/5828/catheter-for-accurate-thrombus-aspiration-launched.html https://biospectrumindia.com/news/97/5828/catheter-for-accurate-thrombus-aspiration-launched.html Thu, 08 May 2014 16:25:00 +0530 The device was launched in partnership with Opto Circuits. Mr Lalit Mamtani, CEO, Eurocor, commented, "The Aspiration Catheter is an ideal product that complements Eurocors product portfolio to offer the best treatment options for vascular interventions, especially for those challenging patient groups like STEMI patients, diabetic patients or patients suffering from small vessel disease in CAD or PAD." Eurocor is marketing the new advice in more than 50 countries worldwide said Opto Circuits in a press statement. The Apertus Aspiration Catheter complements Eurocor's already broad cardiovascular intervention portfolio. Beside drug-coated balloons, stent delivery systems and dilatation catheters, Eurocor now offers an additional device for patient care to treat vascular disease. Apertus offers an innovative elliptic cross-sectional distal form that optimizes the aspiration lumen and reduces friction with the guidewire catheter. Apertus has one of the largest extraction lumen. Its smooth tip is specifically designed to increase deliverability and the innovative shaft brings excellent pushabilty. These features lead to enhanced efficacy with the highest aspiration speed, and excellent deliverability.   A choice of 2 sizes (6Fr or 7Fr guide catheter compatibility) is now availbale according to Opto Circuits' press release. The Apertus Aspiration Catheter is used to remove arterial thrombus, a formation of a blood clot inside arteries. The European Society of Cardiology (ESC) guidelines recommend using thrombus aspiration catheters in primary Percutaneous coronary intervention (PCI) as class IIa treatment for patients suffering from Acute myocardial infarction (AMI). The American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend the aspiration treatment as therapy for ST-segment elevation myocardial infarction (STEMI) patients.   ]]> https://biospectrumindia.com/news/97/7378/bd-launches-new-point-of-care-system-for-hiv-aids-patients-in-india.html https://biospectrumindia.com/news/97/7378/bd-launches-new-point-of-care-system-for-hiv-aids-patients-in-india.html Wed, 30 Apr 2014 10:16:11 +0530 BD Biosciences, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, has announced the launch of the BD FACSPrestoTMNear Patient CD4 Counter system that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to stage and monitor HIV/AIDS patients. With an intuitive language-independent graphical touchscreen interface and on-board videos to guide operation, the BD FACSPresto system can be easily transported and operate off a rechargeable battery, enabling patients even in remote settings to receive critical CD4 testing. CD4 testing allows HIV/AIDS patients to have access to treatment and monitoring, reducing the probability of transmitting the infection to others and providing a plan for improved long-term care. Immediate treatment for infected individuals who meet medical guidelines can dramatically quell the spread of HIV according to the World Health Organization (WHO). This is particularly important as many new cases of HIV/AIDS are transmitted from people who are not aware they are infected. , "The BD FACSPresto system expands the ability to stage and monitor HIV/AIDS patients close to their homes," said Claude Dartiguelongue, Worldwide President, BD Biosciences. "We have taken great care to ensure that the system meets the needs of resource-limited settings, such as featuring intuitive operation, without compromising our standards of precision and high-quality results." The workflow begins with blood collection from a finger-stick or venipuncture and is transferred to a single-use disposable cartridge. To increase the number of tests that can be conducted per day, the cartridge is incubated outside the instrument for 18 minutes. After incubation, the cartridge is inserted into the BD FACSPresto system and results are available in less than four minutes. To ensure quality and consistency of testing, on-board reagent and instrument quality control is performed with each result. Results from clinical studies demonstrate that the BD FACSPresto system performs comparably with traditional analyzers, including the BD FACSCaliburTM cell analysis system, in terms of accuracy, precision and linearity across a wide measuring range. Bringing this same level of testing precision to resource-limited settings assures operators and patients a high degree of confidence in results.   The cartridge uses dried reagents and offers stability across a wide range of storage conditions. In addition, the system is portable and weighs only 6 kg (13.2 lbs.). The BD FACSPresto system is CE-IVD marked and available now. The system is priced competitively compared to existing CD4 systems currently on the market. Pricing for both the system and reagents will align with expectations of the Clinton Health Access Initiative (CHAI), President's Emergency Plan for AIDS Relief (PEPFAR), The Global Fund, Partnership for Supply Chain Management (PFSCM), and UNICEF. ]]> https://biospectrumindia.com/news/97/3779/ge-healthcare-unveils-first-pet-ct-designed-in-india-.html https://biospectrumindia.com/news/97/3779/ge-healthcare-unveils-first-pet-ct-designed-in-india-.html Tue, 22 Apr 2014 16:13:47 +0530 The new Discovery IQ is the result of $15 Million (INR 90 Crores) investment, and 3 years of close collaborative development with Indian nuclear medicine physicians and oncologists. "Three years back, we promised to develop an advanced yet affordable PET/CT to improve access to early cancer detection. We are extremely proud that we have realized that commitment today with the launch of Discovery IQ that is 40% more affordable and can usher in personalized treatment for the patient. We are extremely thankful to the Indian healthcare providers for their close collaboration and insights into their needs that helped develop this important weapon against cancer", said Ms Terri Bresenham, president & CEO, GE Healthcare South Asia. The new GE Discovery IQ PET/CT comes with advanced early disease detection capabilities as well as measurements to understand patient's response to cancer treatment. "Molecular imaging is the epitome of healthcare imaging technologies. GE is very pleased to demonstrate to the world India's capabilities in developing the most sophisticated medical technologies," she added. "We know that cancer patients don't always respond to their initial course of treatment," said Mr R Suresh Kumar, GM, PET/CT Product Development, GE Healthcare. "If we can give clinicians a more accurate and reliable solution to determine early whether the treatment is working or not, they will be able to tailor a regimen of therapies according to individual patient response and needs." "Clinicians will now have ready access to tools that will allow evidence based and cost effective treatment. Together with our customers, we are focused on improving access, quality and affordable cancer care for the patient", said Mr N R Balamurugan, director, Oncology, GE Healthcare South Asia.   ]]> https://biospectrumindia.com/news/97/3773/anti-drip-functionality-on-cole-parmers-process-drives-.html https://biospectrumindia.com/news/97/3773/anti-drip-functionality-on-cole-parmers-process-drives-.html Tue, 22 Apr 2014 12:39:39 +0530 Thus, customers can now choose from either 316 stainless steel or powder-coat steel housings. The L/S Digital Process Drives are ideal for automated process applications including fluid transfer, dispensing, and metering in lab, process, and washdown environments. Automate dispensing by using the programmable dispense interval with a selectable delay between cycles. Programmed calibration delivers dispense and display accuracy, with the drive storing one calibration per tubing size. Easy-to-clean washdown drives can be simply hosed down. Full remote control capabilities included for added convenience. The I/P Digital Process Drives offer rugged performance with precise control. Used for fluid transfer, dispensing, and metering applications in lab, process, and industrial environments, these drives can be found in pharmaceutical, food & beverage, dairy, chemical, manufacturing, and water treatment facilities. A programmable dispense interval allows users to set the delay between dispense cycles for automated dispensing by time or volume. Precise PWM speed control (±0.1%) maximizes accuracy and efficiency while the brushless motor provides maintenance-free reliability. ]]> https://biospectrumindia.com/news/97/3771/cole-parmer-launches-precision-measuring-instruments.html https://biospectrumindia.com/news/97/3771/cole-parmer-launches-precision-measuring-instruments.html Tue, 22 Apr 2014 11:51:36 +0530 The Digi-Sense brand offers new technologies that deliver accurate readings while withstanding rigorous use. From environmental testing meters to performance monitoring equipment, many of the items are precalibrated to save time, cost, and effort. With products individually calibrated before shipment, the measurements provide an unrivaled level of confidence. The Digi-Sense brand currently includes 25 models of thermometers, infrared devices, humidity meters, anemometers, light meters, and manometers. Additional products that fill other measurement needs will soon be available according to the company's press release. Digi-Sense also features a comprehensive line of temperature probes with customization available for unique applications. The new suite of products is designed to meet the ongoing needs of technicians. With more than 50 years of experience, Cole-Parmer is a global leader in supplying fluid handling, life science, and general laboratory products, instrumentation, and equipment to the Biotech, Chemical, Academics, Environmental, Food, Industrial Manufacturing, and Print industries. Offering a wide selection of products and instrumentation, Cole-Parmer works with R&D, pilot plant and production, specializing in providing scale-up assistance. With a mix of proprietary products and strategic partnering with leading manufacturers, Cole-Parmer's business is highly diversified across a spectrum of products, consumables, services and solutions. ]]> https://biospectrumindia.com/news/97/5166/strand-life-sciences-partners-with-mazumdar-shaw-medical-foundation-.html https://biospectrumindia.com/news/97/5166/strand-life-sciences-partners-with-mazumdar-shaw-medical-foundation-.html Mon, 21 Apr 2014 18:32:59 +0530 Strand, a global life sciences & clinical genomics company headquartered in Bangalore, entered into a partnership with the Mazumdar-Shaw Medical Foundation (MSMF) to set up the Strand at Mazumdar-Shaw (SAMS) translational lab in the Mazumdar-Shaw Centre for Translational Research (MSCTR) in Bangalore. This is a major milestone towards enabling an ecosystem of personalized medical treatment for patients with cancer and other genetic diseases. "It gives us great pleasure to partner with Strand Life Sciences, a pioneer in genomics and personalized medicine. With evolving healthcare systems, it is imperative that we are constantly innovating and developing capabilities that will provide personalized treatment and quality care to the people of India. We believe this collaboration will help us foster innovation and encourage in-depth research in the genomics space and thereby provide better care for patients with cancer and other genetic diseases," said Dr Kiran Mazumdar-Shaw, CMD, Biocon. Based on statistics, nearly seven lakh Indians die of cancer every year, while over 10 lakh are newly diagnosed with some form of the disease. According to the latest World Cancer Report from the World Health Organization (WHO), there are over 4.77 lakh men and 5.37 lakh women diagnosed with cancer in India in 2012 alone. The scale of these challenges requires the Indian healthcare industry to use affordability as a driver of innovation. Strand through its expertise will offer comprehensive genomic testing for cancer and other germline or hereditary conditions at highly affordable costs. In addition, the collaboration will also entail promoting research in the field of genomics, conducting medical and non-medical programs, seminars and talks shows, assisting clinicians and scientists in performing quality research, and towards making genomics research resources and data available to scientists. Talking about this partnership, Dr Vijay Chandru, Chairman & CEO, Strand Life Sciences said, "The Mazumdar-Shaw Medical Foundation has shown great foresight and magnanimity in helping us work towards the goal of providing the leading edge of genomic medicine at affordable prices in India and elsewhere. This collaboration provides Strand with an exciting opportunity to conduct and promote in-depth research in the field of genomic sequencing based diagnostics." He further added, "This partnership is recognition of our joint commitment to bringing best-in-class healthcare technologies closer to people in India at affordable costs. As part of the vision laid out in the partnership, Strand has developed an affordable Hereditary Breast Cancer Diagnostic Test that will cost significantly less than comparable tests available in the West and India. This is the first of many innovations that we will develop at the SAMS translational lab"     ]]> https://biospectrumindia.com/interviews/97/3151/our-mantra-is-to-reach-out.html https://biospectrumindia.com/interviews/97/3151/our-mantra-is-to-reach-out.html Mon, 21 Apr 2014 12:33:33 +0530 Q: How successful has been the Cross Labs experiment so far? How is it different from what your competitors offer? Cross Labs is an activity wherein we use our installed base for doing multiple product lines. We not only offer our services to the labs on the instruments we manufacture and sell but the others as well. This is the basic premise for the cross labs concept. This is a unique one and not many have similar kind of set ups. Only one competitor has similar kind of offering. But we have been way ahead. If we have three competitors then it is obvious that few clients will have installations of theirs besides ours. When we offer servicing of our instruments, we also offer for the competition too. Therefore, the client doesn't have to contact different vendors. We always ensure that we have quality spare parts. When three years back we ventured into the area, people used to look at it carefully but over the time, it has emerged as a successful model. Q: Who are your clients? How many platforms you deliver annually? Agilent has got a big market share in pharma. We have been also growing significantly in food testing where we have done exceedingly well in last two years. The other areas that we have been focusing on are material and environmental sciences. In parallel, we have been also been looking at education market. We are reaching out to colleges and universities and focus is on the direct channel so that there is quality.   We deliver 100-150 platforms every year. Our mantra is to penetrate or reach out to new clients. I feel personally it is not relevant how many instruments have we sold but it is critical for us to know how many new customers we have added. Our percentage of contribution to new clients has been growing. Our centre based out of Manesar in Haryana, is not only focussed on India but it also looks at global operations such as finance and back end. We share our centre of excellence for business support and showcase instrumentation. In Bangalore, we have global R&D centre that is dedicated to find new solutions and fine tune the existing technologies. We have offices across the country to reach out even to remotest village to provide the pre-sales and post-sales support. We are at the top in terms of service expectations. Q: How has been your performance? Have you introduced any new technologies? In terms of overall market and business, the Indian market has been pretty challenging. Especially with the rupee depreciation, the instruments have become 30% more expensive in last 18 months. End consumers have limited budget and competition also adds to our challenge. However, we did fairly well despite that. Our growth has been half more than that of the market. We have still grown despite this and even more than market growth rate. We have also grown much beyond the market growth in consumables. We have not launched any technology per se. But we have improved the existing technologies through modification by specifications and turnaround time. When you ask about HPLC, it has become a common commodity today. There is no room for any changes in it as far as I can see. We have introduced the Microwave Plasma- Atomic Emission (MP-AES) for cost effective elemental analysis capabilities. The technology runs on air instead of argon gas cylinders required generally. It is much environmental friendly. Q: What kind of market competition exists and how do you deal with it?   For instruments, I don't see much of Indian players. Infact, we have four to five multi-national players dominating the market. The competition surely does exist and it is mostly about the pricing. But our focus on quality is supreme. We may have lost few major projects to competition on pricing but never on quality. We have restrictions on how much we can go down and are also bound by our principles. The rupee depreciation also is a factor here. Our products are dependent on dealers and we have been non-competitive on prices. But despite that we have done well. Q: Has the client behaviour changed over time? Did that anyways add to your challenges? There have been multiple changes since past few years. The clients previously knew about the technology through vendors who were loyal. But it has changed. Awareness is increasing through the internet opening up. Clients ask questions which we had not dealt earlier. In terms of knowledge, they are doing well. On commercial front, there is a competition on price between service providers. Although the rate might not differ much but we surely don't have any price war here. Agilent has always scored high on that front of quality and value for services. It is important what product value and presentation we offer. The challenge is on the tendering process. Most of the big pharma companies and academic institutes ask for increased service time. Sometimes the five year warranty and ten year maintenance asked by them is too much. It becomes difficult to commit for such a period of time as these days instruments hardly last for that much time due to new technologies coming up. Q: What are the immediate challenges before you? Are there any expectations from the new government at centre? The funding has witnessed significant decrease. Generally in March, we have lots of funds but this time the elections have made the allocations suffer. Academia and research generally give procurements orders at this time but that has slowed down. Our expectations are that the new government's focus will be on building institution infrastructure (labs) so that we can gain opportunities. We expect the dollar to go down against rupee. We want the next government to be business friendly and supportive of the industry.   Q: What is the future outlook of your company? We are into petro-chemicals, material sciences and agriculture, expecting to do well in these areas. Once the government mines are opened, we expect to do good business from mining too. Our outlook for next few years is to enhance coverage to universities, go into new areas, reach out to academic institutions, and build up infrastructure. We will keep growing significantly beyond the market rate. ]]> https://biospectrumindia.com/reports-white-papers/97/3763/healthcare-it-registers-highest-vc-funding-ever-in-q1.html https://biospectrumindia.com/reports-white-papers/97/3763/healthcare-it-registers-highest-vc-funding-ever-in-q1.html Wed, 16 Apr 2014 13:26:00 +0530 Mercom Capital Group, llc, a global communications and consulting firm has released its report on funding and mergers and acquisitions (M&A) activity in the Healthcare Information Technology (IT) sector for the first quarter of 2014. Mercom's comprehensive report looks at deals of all sizes in Healthcare IT across the globe. Venture capital (VC) funding in the sector continued at a record pace with $858 million raised in 163 deals, a 154 percent increase compared to the $337 million raised in Q4 2013. This was the highest dollar amount raised by the sector in a single quarter to date. "Funding into the Healthcare IT sector continues at an astonishing pace. Venture capital funding in Healthcare IT has reached almost $5 billion in about 1,000 deals since 2010," commented Raj Prabhu, CEO and Co-Founder of Mercom Capital Group. Healthcare practice-focused technology companies received half of all VC investments in the first quarter of 2014, with $460 million in 60 deals. Areas that received the most funding under this category were Practice Management with $124 million in eight deals, Health Information Exchange with $78 million in two deals, and Data Analytics with $43 million in seven deals. Consumer-focused companies received $398 million in 103 deals, with the majority of the funding going into the Mobile Health category ($198 million in 61 deals). Telehealth companies received $79 million in 14 deals and Scheduling, Rating & Shopping companies received $66 million in six deals   There were 65 early-stage deals under $2 million, including 29 accelerator/incubator deals in Q1. Investments going into early-stage deals ( < $2 million) were more consumer-focused compared to deals of over $2 million, which were going towards practice-focused technology companies. The top VC funding deal in Q1 2014 was the $89 million raise by Dedalus Group, a Healthcare IT systems company providing software solutions for clinical, general practices, and hospitals, from Hutton Collins and other investors. Other top deals included the $77.5 million raise by MedHOK, a provider of a single platform for care, quality and compliance for health plans, pharmacy benefits managers and other risk-bearing entities by facilitating real-time information sharing, from Bain Capital Ventures and Spectrum Equity; MINDBODY, a provider of scheduling and business management software for health and wellness companies, which raised $50 million from investors including Bessemer Venture Partners, Institutional Venture Partners, Catalyst Investors, W Capital Partners, and Montreux Equity Partners; the $41.4 million raise by Clarity Software Solutions, a provider of on-demand document management and communications delivery solutions for the health insurance industry, from North Bridge Growth Equity; and Health Catalyst, a provider of healthcare data warehousing, which raised $41 million from Sequoia Capital, Norwest Venture Partners, Kaiser Permanente Ventures, Sorenson Capital, CHV Capital, and Partners HealthCare System. There were 188 VC investors and eight accelerators/incubators that participated in Q1 2014. There were 19 investors that participated in multiple rounds; Khosla Ventures was the most active with three deals. U.S.-based Healthcare IT companies accounted for 87 percent of all deals. However, we are seeing more Healthcare IT activity globally, with 15 other countries recording at least one funding deal. Within the United States, California continued to be the most active state accounting for 42 deals, followed by New York with 13, Maryland with 10, Massachusetts with nine, and Florida with six. Among cities, San Francisco led with 13 deals followed closely by New York with 11. In terms of dollars, Tampa led with $78 million, followed by San Luis Obispo with $50 million and New York with $44 million.   Mergers and acquisitions (M&A) activity in the Healthcare IT sector was at its highest level, totaling 53 transactions, only six of which were disclosed for a combined total of $4.7 billion, compared to 44 transactions in Q4 2013. Health Information Management companies saw the most M&A activity this quarter with 18 transactions, followed by Service Providers with 13, and Mobile Health companies with eight. The largest disclosed transaction was the $4.4 billion acquisition of MultiPlan, a company that manages claims processing and provides healthcare cost management solutions through its network and analytics-based technology platform, by Starr Investment Holdings, an investment firm focused on long-term investments, and Partners Group, a private markets investment management firm. This was followed by the $130 million divestiture of HealthTronics, a provider of EHR for urology practices, from specialty healthcare company Endo Health Solutions to Altaris Capital Partners, an investment firm focused on the healthcare industry. Semiconductor chip maker Intel Corporation acquired Basis Science, a provider of wearable device technologies for health and wellness applications, for nearly $100 million. Other disclosed transactions were the $16.15 million acquisition of Health Care Compliance Strategies, a company providing online compliance training for healthcare organizations, by HealthStream, a provider of workforce development and research/patient experience solutions for the healthcare industry, followed by the $6.5 million acquisition of Unibased Systems Architecture, a provider of patient access solutions including enterprise scheduling and surgery management software, by Streamline Health Solutions, a provider of enterprise content management and business analytics solutions for healthcare organizations. Vocera Communications, a provider of point-of-care communication solutions, acquired mVisum, a provider of alarm management technology solutions for health systems, for $3.5 million. Announced debt and public market financing in Healthcare IT amounted to $343 million in six deals in Q1 2014, compared to $36 million in seven deals in Q4 2013. Two Healthcare IT IPOs in Q1 2014 raised a combined $304 million. Castlight Health, a provider of healthcare transparency solutions, brought in $204 million through its IPO in March and Everyday Health, a provider of digital health and wellness solutions launched an IPO that raised $100 million. Total corporate funding in the Healthcare IT sector, including VC, accelerator/incubator, debt, and public market financing in Q1 2014 came in at $1.2 billion. There were a total of 464 companies and investors mentioned in this report. ]]> https://biospectrumindia.com/news/97/7687/novozymes-enables-gsks-eperzan.html https://biospectrumindia.com/news/97/7687/novozymes-enables-gsks-eperzan.html Mon, 14 Apr 2014 11:13:00 +0530 The drug uses albumin technology from Novozymes to extend the drug's presence in the patient's body. Many injected treatments require daily dosing, which can be challenging for patients. Pharma companies are therefore seeking to develop longer lasting drugs that allow patients to dose less frequently. Known as VELTIS, the Novozymes technology that extends the active drug lifespan is based on albumin, a naturally occurring protein that can be found in human blood. "The first approval for a product based on Novozymes' VELTIS technology, and marketed by one of the largest pharmaceutical companies in the world, marks a significant milestone for our half-life extension technology", said Mr Thomas Videbæk, executive vice president, Novozymes. "We consider this authorization as a real proof that VELTIS can offer true benefits to patients, reducing the inconvenience associated with daily drug dosing."   Albumin works as a vehicle that transports the active drug ingredients throughout the body and increases the lifespan of the drug in the patient's system. VELTIS was originally developed in baker's yeast, and the technology was acquired by Novozymes via the purchase of Delta Biotechnology based in Nottingham, UK in 2006. As in the case of GlaxoSmithKline's Eperzan, dosing just once a week means that patients can self-administer with greater ease and convenience. Simplified dosing can help patients comply with the recommended medication regimen and benefit fully from the drug. Eperzan is the first approved drug based on the Novozymes' albumin technology. Recently, Novozymes also announced a collaboration with Janssen to evaluate the albumin technology for potential new drug candidates. GlaxoSmithKline has also applied for marketing approval for Eperzan in the US. The drug is currently undergoing assessment by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) review date April 15, 2014. The authorization does not impact Novozymes' financial outlook for 2014.   ]]> https://biospectrumindia.com/features/97/3082/tomorrow-carries-its-own-risks-and-uncertainties.html https://biospectrumindia.com/features/97/3082/tomorrow-carries-its-own-risks-and-uncertainties.html Fri, 11 Apr 2014 14:24:27 +0530 The beginnings The company was founded by the dynamic duo, Mr R Narayanan, also known as 'Naru', serving as the chairman, and Dr Saleem Mohammed, who serves as the CEO and cofounder of Xcode Life Sciences. Xcode's portfolio spans across areas including bioinformatics, genetics and nutrition, through which it aims to promote preventive health practices and lifestyle among its customers. Speaking about the company's potential, Dr Saleem Mohammed said, "At Xcode, we see ourselves pioneering in the personalized nutrition and medicine space, specifically for lifestyle related condition. Our long-term vision is to discover genetic causes of these illnesses that would help in accurate indication of onset of diabetes, obesity, CVDs and stroke. The data that we collect will serve as gold standard and will be used for R&D to make our prediction models more accurate." The offerings   Xcode is currently focusing on areas of more imminence. One such area is pharmacogenomics, which analyses a person's genetic make-up for reaction to certain drugs. Today it is a 16-membered organization, who have expertise in the field of medicine, nutrition, genetics, bioinformatics, sales and marketing. "Xcode is targeting the drug called Clopidogrel, which is prescribed to prevent the formation of blood clots in arteries. However, it works on only 70% of Indians. Many times, people are forced to go in for a bypass surgery or have a stent put in place in their arteries because the Clopidogrel drug did not have an effect on them. With pharmacogenomics, this can be addressed by either increasing the dosage or changing the drug. Xcode is partnering with hospitals and cardiologists for this project," adds Dr Mohammed. The company also recently launched India's first genetic-based anti-aging program called 'Come alive', which will provide genetic assessment of aging for individuals. Xcode was founded as a one-member start-up and the initial formation of core team were crucial for the company. Funding and Capital   Says Dr Mohammed, "We were lucky to have had an angel investor as a co-founder 6 months after we were incorporated. A challenge most start-ups face is building the core team. This is a slow process and an important one. We are constantly on the lookout for team members who are innovative in their thinking and who want to make a difference. We are gifted with a team that believes an aligned vision and steering towards the lofty goals we have set for ourselves." Since personalized genomics is still at a nascent stage in India, it required an enormous effort for the company to raise awareness about it. The initial capital came from Dr Mohammed and the Department of Science & Technology (DST, Government of India) in the form of a grant. The funding was used to develop the technology to build a proprietary genetic database, SNP panel and as well as the algorithm to calculate the risk of diseases. Xcode also received angel funding from cofounder Mr R Narayanan as well. Genomics in India Today, genomic testing is finding importance in both primary (preventive) as well as secondary and tertiary care. Close to 78% of Xcode's customers are men, and 22% are women.   About 60% hail from South India and the rest from Northern India. According to Dr Mohammed, the average age of someone who would take up an assessment is said to be about 41. Dr Mohammed says that pharmacogenomics has existed in the West for the past 5-6 years. "However, compared to the west, in India we attend to health only when we start seeing symptoms as opposed to being preventive. In fact health checks have gained traction only over the last 10 years. And believe it or not, a simple DNA assessment can be a lifesaving decision. Despite the advantages, there are challenges we face in terms of educating and raising awareness simply because of how nascent the science is," he adds. The concept of personalized and preventive healthcare through understanding genetic risk is in itself is considered new to India. Driving innovation When asked about innovation at Xcode, Dr Mohammed opines, "We have an open culture and encourage entrepreneurship within the company. We give freedom to our team members to take decisions independently. We have a flexible work environment that motivates them to think out-of-the-box. Most of the members of Xcode have an interdisciplinary background so they can cross utilize their experience across different domains."   Unlike other technologies and verticals, Genomics is personal and India will have a unique footprint compared to other countries. India has the potential to carve a niche and home-brewn organizations or ideas will have a significant role to play in raising the bar. Role of public-private partnerships "There is an urgent need to foster public-private partnerships (PPPs) or other such successful working models of building infrastructure space. It is the responsibility of almost every organization directly or indirectly involved in life sciences, relevant NGOs and government bodies to educate public and medical community on the immense potentials of genomic technology use and research," elucidates Dr Mohammed. Xcode's is currently partnering with Naturals, a leading beauty chain in South India. It has also partnered with several hospitals in Chennai offering personalized medicine program.   "We have collaborated with Sri Ramachandra Medical College (SRMC) and SRM University as part of academic collaboration to study the effects of personalized medicine," said Dr Mohammed. Dr Mohammed feels that PPPs should not be a theoretical concept or a vote-winning trick. He comments, "We would like to see PPP translated in real life, in actual practice, and in the field of genomics. If this were to happen, then we have the capability to establish a National Chronic Lifestyle Diseases Prevention Center." The future outlook Dr Mohammed also remarked that Genomics is going to drive the next wave of personalization of medicine, nutrition and fitness. He explains, "Genomics has the potential to save lives. Genomic data along with other types of aggregated information such as lifestyle and clinical data can bring about accurate risk predictions."   Dr Mohammed exclusively enlists 5 learnings that he encountered in his entrepreneurial journey: People invest in people. Not businesses. It is people, both internally and externally, that make a business. Creating awareness is critical to success. Speed is extremely critical in a start-up. Build a team that stands by you, they need to be believers of your vision. As a final piece of advice for the young blood who want to take the plunge in the entrepreneurial adventure, Dr Mohammed concludes by saying, "Starting tomorrow will always carry its own risks and uncertainties. So if you are planning for a start-up, do it now."   ]]> https://biospectrumindia.com/interviews/97/3752/india-to-be-fastest-growing-market-in-asia-pacific.html https://biospectrumindia.com/interviews/97/3752/india-to-be-fastest-growing-market-in-asia-pacific.html Mon, 07 Apr 2014 12:10:00 +0530 Illumina, Inc., was listed #1 in the top 50 global smartest technology companies by the MIT's Technology Review magazine. The company has been a market leader in the genomics and sequencing technologies. BioSpectrum's Rahul Koul spoke to one of the top executives of the company to know its India focused strategy: Q: What is the purpose behind your visit to India? How do you perceive India and Asia-Pacific region as a destination for doing business? Since this was my first visit to India, the basic purpose was to meet customers and understand their needs. India is a substantial market for sequencing as it relates to medical research, agriculture, non-invasive prenatal testing and biopharma. We consider India in particular and Asia Pacific in general as important regions for our growing business. India still is a very challenging market for technology companies. Its import/export policies, regulations and government funding processes are complex at times. However, we see India as an emerging market; it has a lot of potential. We will keep investing for the long-term benefits in genomics. Apart from India, the Japanese market has been promising. It has had resurgence in genomics and the government believes in the genomics movement. We saw an incredible growth there. The market in China continues to grow quickly as well. Both China and Japan are relatively bigger markets than India. China has seen decent growth in last 2-3 years but it has been a steady growth and not exponential. We think that the exponential part of the curve in India is still to come. I think there is a lot of opportunity over the next 4-5 years and I would expect to see exponential growth in India. I feel that there is no reason why India cannot be the fastest among all the nations in Asia Pacific. Q: How has the genomics landscape transformed over the period of time? Where do you stand here?   We have seen on global basis that the market for genomic technology has grown and it is going to be a multi-billion dollar industry. For Illumina, our overall total addressable worldwide market for 2014 is approximately $20 billion. The markets which Illumina's technology addresses are large, untapped and numerous; including but not limited to, oncology, reproductive and genetic health, forensics, consumer, agriculture and molecular diagnostics, as well as basic, translational and pharmaceutical research. Further, there are many other market opportunities which could double or triple the company's addressable market in the future. In the next decade, genomics is going to have a significant impact on the treatment of cancer and genetic diseases. Much research has been done and the Indian market can benefit greatly. This is especially true when we talk about the reproductive and genetic health. I think the potential of genomic technology for use in developing diagnostics and conducting non-invasive prenatal testing is phenomenal. These uses alone will change the healthcare landscape. Additionally, we estimate that the addressable market for oncology is approximately $10 billion. At Illumina, we put a tremendous focus on developing new technologies at a lesser cost. We have a strong market share thanks to our unique product portfolio. One of our core strengths has been to create new products that are truly innovative and transformative. For us, the future involves creating a wealth of information that can be used to inform research and ultimately help treat disease. Our CEO, Mr. Jay T. Flatley says, 'Come one day, every baby will be sequencing at birth' and we believe that. We are making our sequencing technology a powerful tool for the human use. As I mentioned, our technology has applications in different areas. Some of our customers are doing research in agriculture to ensure our food supply is safe. Others work in forensic science, population sequencing, cancer and reproductive and genetic health. For population sequencing, the goal is to better understand the true nature of the genetic diversity across populations. To me population sequencing is one of the most exciting areas, as we come to know about genetic basis of a disease in a holistic way across different ethnicities. This can change the face of the healthcare. Q: Please throw some light on the latest trends in the sequencing? How has it transformed the research over the period of time?   There have been continuous evolutions of technologies. I think first of all the future looks extremely bright for whole genome sequencing. At Illumina, we have reduced the sequencing cost considerably. When the world started whole genome sequencing in the 1990′s, the Human Genome Project spent $2.7 billion over 13 years to sequence the first human genome. The HiSeq X Ten, which we launched this January, can sequence the entire genome for researchers for $ 1000. There is a two million fold decrease in the cost in less than a decade. We see quite a bright future ahead for the technology. There have been several companies trying to develop new sequencing techniques (semiconductor and nanopore technologies), but the reality is that if you look at the state of world, it will be difficult for them to develop effective sequencers and then compete at a higher market. That said, the market is big enough for multiple technologies but keep in mind, 90 percent of all sequencing done in the world, is done with Illumina's technology. Q: Are the technologies affordable for the small and medium scale companies as well? Our technologies are becoming increasingly affordable with each passing month and year. If you look at our portfolio, you see MiSeqDx system which was the first genome sequencer to be cleared by the U.S. Food and Drug Administration. It was designed specifically for clinical laboratories in that it is small enough to sit on a desktop, and easy enough to use so that anybody in the lab can run it, not just a specialized technician. We also recently introduced the NextSeq 500 System which is capable of sequencing a whole human genome in a single run. It delivers the power of high-throughput sequencing with the simplicity of a desktop sequencer. It transforms exome, transcriptome and whole genome sequencing into everyday research tools. Our goal is to make the sequencing ubiquitous. Q: What are services or products offered by the company in India? Illumina offers a full range of products - from microarrays to sequencing systems. Illumina's BeadArray microarray technology represents a fundamentally different approach to high-density arrays. Our array-based solutions provide ideal tools to perform genome-wide association studies (GWAS) involving single-nucleotide polymorphism, genotyping and copy number variation analyses, as well as gene expression profiling, and other DNA and RNA studies. On sequencing part, the portfolio includes the MiSeq System which combines speed, high-quality data, and the longest read lengths of any desktop system. It is ideal for sequencing targeted panels, amplicons, and small genomes. It is a cost-effective alternative to capillary electrophoresis applications and can perform rapid sequencing and variant detection for time-critical studies. MiSeq has an output of 0.3 - 15 gigabases (Gb) and a maximum read length of 2 x 300 bp. For production-scale genome, exome, transcriptome sequencing, there is the HiSeq 2500. It has two modes - rapid run and high-output. Its output range is 10-1,000 Gb and it is capable of sequencing a whole human genome is around 24 hours. In January we launched two new products. The HiSeq X Ten is the world's first platform to deliver full coverage human genomes for less than $1,000, inclusive of typical instrument depreciation, DNA extraction, library preparation, and estimated labor. Built for population-scale human whole genome sequencing, the HiSeq X Ten is an ideal platform for scientists and institutions focused on the discovery of genotypic variation to enable a deeper understanding of human biology and genetic disease. It can sequence tens of thousands of samples annually with high-quality and high-coverage. The HiSeq X Ten System is sold as a set of 10 or more HiSeq X sequencers, each generating up to 1.8 terabases (Tb) of sequencing data in less than three days or up to 600 Gb per day, per system, providing the throughput to sequence tens of thousands of high-quality, high-coverage genomes per year. So it is a revolutionary product. We already had three clients from Asia Pacific, one from Korea and one from Australia. It costs $10 million, but we achieved a technology that can do wonders. Q: What is the kind of competition you have globally and in Asia Pacific? There are many competitors such as Life Technologies which is a part of Thermo Fisher now. Pacific Bioscience is another. It has interesting technology, but it is not competitive due to price. The reality is that Illumina has made more advances in sequencings than any other company in recent times. What I love about Illumina is that we have great talent. We have strong optical engineers, bioinformaticians, molecular biologists and engineers. It is a very diverse world class skill set that is required to create such technologies. We have developed core competencies in the nano-fabrication and manufacturing of flow cells. We have been fortunate to master the talent and stay ahead of the competition, but at the same time we respect our competitors. Q: Are you considering venturing directly for marketing in India or through distributors? It is all through distributors at the moment and we are pleased with them. We always try to put more resources and support for them. We educate and train their workforce and in fact, many of them get the training at our Singapore office. Our technical support system helps educate clients there to know more about the utility of genomics. PREMAS Biotech is our distributor in India for few years now and it has been doing a tremendous job. They have performed their task to our expectations. In the coming years, we hope to have our own office in India. Q: What is the revenue of the company globally and from Indian market in the last fiscal and how are you expected to do this financial year? Globally, we have recorded $1.4 billion in revenue with an annual growth of 24 percent. We don't reveal specific growth matrix for each country, but in the case of India, I can say that it has matched our performance globally and over the period of 3 years, it has maintained 25 percent growth rate. Looking at 2014, we expect to grow between 16 to 20 percent. Q: What do you consider as your major challenges and what is the outlook for the future? We are constantly growing so we are continuously scaling-up our infrastructure to manage our expansion and to serve our customers to the highest level of satisfaction. This can be challenging, as it is for any company that is the leader in its respective industry. We have to ensure that we always have enough resources and a solid infrastructure. The main challenge is that we keep innovating at a fast pace and therefore need to keep our customers updated. Overall, we have to ensure that we remain focused. We want to be part of communities to change the world for better, or as we say at Illumina, "we want to advance human health by unlocking the power of the genome." ]]> https://biospectrumindia.com/news/97/7319/eppendorf-launches-mastercycler-nexus-x2-for-simultaneous-pcr-runs.html https://biospectrumindia.com/news/97/7319/eppendorf-launches-mastercycler-nexus-x2-for-simultaneous-pcr-runs.html Wed, 02 Apr 2014 11:49:41 +0530 This instrument is said to be ideal for researchers looking to carry out two runs of PCR simultaneously, without any compromise on the number of samples. The instrument comprises of two asymmetric blocks, consisting of 64 and 32 wells, which can be programmed and run completely independently, enabling two separate PCR protocols to be run in parallel. With reduced noise emission (< 40 dB), low power consumption and a small, well-designed footprint, the Mastercycler nexus X2 is perfectly suited for use in busy academic laboratories, or any institution with multiple users or large research groups. In comparison to other dual block cyclers, it provides an elegant solution for users wishing to run procedures using a large number of samples, without taking up a large amount of bench space. "Many of our customers have expressed a need for a multi-block cycler that can accommodate more than 48 samples in a single block," said Dr Kay Körner, global senior product manager of PCR, Eppendorf. "In response to this, we developed the Mastercycler nexus X2's asymmetric block. In nature, functional asymmetry is a well-known phenomenon - we are confident it will also work in a lab," he further commented. As the latest addition to the popular Mastercycler range, the Mastercycler nexus X2 continues Eppendorf's legacy of exceptional design and ease of use combined with efficiency and accuracy.     ]]> https://biospectrumindia.com/news/97/4288/ge-to-invest-rs-720-cr-to-improve-cancer-care-in-india.html https://biospectrumindia.com/news/97/4288/ge-to-invest-rs-720-cr-to-improve-cancer-care-in-india.html Tue, 01 Apr 2014 18:12:00 +0530 The centers will offer latest technology for diagnosing and treating cancer, and will follow the same standards of care found at the world's top cancer hospitals delivered at affordable price points. "At GE, we envision a day when cancer is no longer a deadly disease. Scaling up of affordable access to cancer care requires disruptive solutions and willing partners. We believe a partnership like this one presents a great opportunity to confront India's cancer challenge head on," stated Mr John Dineen, president and CEO, GE Healthcare. He added, "Combining GE Healthcare's innovative technology platforms with CTSI's proven expertise in operating cancer centers affords a fantastic means to tackling cancer early in India." The mortality rates in India are very high due to late cancer detection, access, and affordability to care. "CTSI has built a proven healthcare delivery model tailored to making the highest quality cancer care accessible and affordable. When we launched our international operations, India was a natural place to start. It offers existing medical infrastructure, a pool of talented doctors and a population with the desire to embrace top-notch standards of care. Our partnership with GE accelerates realization of our goal to build out a network in India and ultimately apply our model in similar markets worldwide," added Mr Joe Nicholas, president and CEO, CTSI.   The partnership underscores four critical points to elevate the access, affordability and standard of cancer care in India. First, modern management of oncology patients requires a multidisciplinary approach, meaning that delivering cancer care according to top world standards demands interplay between a team of personnel from a wide range of medical specialties. Second, offering world-class cancer care requires adherence to well-defined, evidence-based medical protocols derived from the world's latest medical research. Third, providing the latest therapeutic options for cancer requires expert use of cutting-edge imaging, treatment and digital record-keeping technologies. Finally, reducing patient effort and spend through a comprehensive and transparent approach in a local, patient-friendly environment. GE and CTSI will configure the network in a hub-and-spoke fashion, with all centers linked by a sophisticated IT network to a hub, and supported by a multi-national group of clinicians, and administrators. The hub will be a centre of excellence with full diagnostic imaging and treatment capabilities while the spoke will have the ability to deliver a range of screening, staging and treatment options. The centers will use globally proven clinical pathways and protocols to standardize the care for every patient. The first hub center, American Oncology Institute, CTSI's international brand, is already operational in Hyderabad, Andhra Pradesh. The first spoke or remote centre is being set up in Andhra Pradesh. The partners will provide a comprehensive oncology service line to interested healthcare providers in small and large cities to accelerate and expand the network across India. The approach will take global standard cancer care closer to the patient and help optimize patient spend through the treatment cycle. Today, a patient from a small town or a rural area spends over 50% on travel and logistics for treatment. The GE-CTSI partnership provides hospitals with cutting edge solutions that cover clinical and technical aspects necessary to offer cancer care to patients found at top hospitals throughout the United States and Europe, including clinical technology, medical physics services and a worldwide IT network. "CTSI's centralized model features a comprehensive approach to care that combines evidence-based protocols and robust administrative support to promote consistent clinical decision-making and a patient-centric environment. In our experience, this leads to the best outcomes and service for patients," commented Mr Andrew Shogan, COO, CTSI. "The partnership between GE and CTSI reflects our shared commitment to tackling cancer earlier and will offer Indian patients the same caliber of preventive, diagnostic and therapeutic options found at any leading cancer center around the world but at affordable price points for patients in India. The Indian healthcare landscape is evolving rapidly. GE and our partners at CTSI are looking forward to being at the vanguard of this progress by setting up a complete oncology ecosystem," concluded Ms Terri Bresenham, President and CEO, GE Healthcare South Asia. GE Healthcare has committed USD 1 billion towards accelerating research and development of advanced oncology solutions. GE Healthcare offers a wide portfolio for oncology and a strategy that combines cellular research, medical imaging, laboratory diagnostics, biopharmaceutical manufacturing technologies, and information technology. Cancer Treatment Services International (CTSI) is a provider of university-level, comprehensive treatment for cancer patients with a main focus on medical oncology and radiation oncology. CTSI provides innovative and technologically-advanced treatment solutions through IT-based model that allows integration and centralization of core services. The company currently operates centers and has development projects in both domestic and international markets. ]]> https://biospectrumindia.com/news/97/8446/bd-appoints-varun-khanna-to-spearhead-india-operations.html https://biospectrumindia.com/news/97/8446/bd-appoints-varun-khanna-to-spearhead-india-operations.html Tue, 18 Mar 2014 15:33:00 +0530 Mr Varun Khanna joins BD at a time when the company is strategically focused on driving growth through innovation and customer focus. India is one of the key markets and is central to BD's growth strategy in Greater Asia. He joined BD from Fortis Healthcare, where he played a key role in driving the growth of business in two of its fastest growing regions. His most recent role was that of Regional Director - Western and Eastern Region, which he held since 2010. Prior to Fortis, he worked with Etisalat Group, Reliance and Bharti Airtel, in various roles of increasing responsibility including Sales, Marketing as well as P&L Leadership. ]]> https://biospectrumindia.com/news/97/3704/tyrone-offers-hpc-on-demand-and-on-pay-as-you-use.html https://biospectrumindia.com/news/97/3704/tyrone-offers-hpc-on-demand-and-on-pay-as-you-use.html Mon, 17 Mar 2014 17:07:41 +0530 Tyrone, a provider of innovative storage and computing solutions for enterprise data center and high performance computing environments, announced the availability of Tyrone EDRA, a cloud based HPC-on-demand solution made available to customers on demand and on a pay as you use basis with immediate effect. "We believe India is poised to play a big role in global opportunity for HPC applications and related services,'" said Mr Sandeep Lodha, marketing director, Tyrone Systems, "With the launch of Tyrone EDRA on-demand and pay-as-you-use HPC solutions, we believe we are bringing HPC within reach of those academic and commercial users, who hitherto could not afford to invest in this high capex and opex intensive application environment," he added. Tyrone is the first pure player of HPC in cloud in India with a personalized service of their own having their own infrastructure and human interface as opposed to the system driven interfaces. The company plans to tap this market utilizing a workforce that has to its credit an average of 13 years of experience with an urge to constantly strive to make the HPC application better. Tyrone's applications are woven around green computing technologies that support best-in-class, highly interoperable, non-proprietary components from Intel and other leading server component vendors. Tyrone EDRA Salient Features are it has 32 node HPC cluster with 64 x E5-2697v2 processors (768 Cores), 4 nodes have 1x Intel Xeon Phi installed, memory 2048 GB (2.6 GB/per core), HDD- SATA 1000 GB / per node, infiniband interconnect, dedicated redundant lease lines and efficient rack, power & cooling. Tyrone EDRA - available on demand and with flexible pricing. Available to both enterprises and individual customers, Tyrone EDRA can be consumed on demand and on a Pay-as-You-Use basis. The service can be used for few hours or even for months and is accessible anytime, anywhere. Tyrone EDRA target customers are Education & Scientific Research, Manufacturing & Engineering, Financial Services, Life & Material Sciences and Media and Entertainment. ]]> https://biospectrumindia.com/features/97/3697/dr-prathap-reddy-is-a-man-on-a-mission-dr-kiran-mazumdar-shaw.html https://biospectrumindia.com/features/97/3697/dr-prathap-reddy-is-a-man-on-a-mission-dr-kiran-mazumdar-shaw.html Thu, 13 Mar 2014 14:58:00 +0530 The book was released in the presence of distinguished luminaries including Dr Devi Shetty, chairman, Narayana Health and Dr Kiran Mazumdar-Shaw, CMD, Biocon. Two years in the making, and penned by former New York Times journalist, Mr Pranay Gupte, read the epilogue and a short passage from the newly unveiled book. Later he was felicitated by Dr Reddy himself. In his note, Dr Reddy opined, "What she (Dr Kiran Mazumdar) has done is outstanding and remarkable... We need to focus on the need to bring in the change... The world is going to lose 36 million people every year to non-communicable diseases... It is a crime to not to take care of yourself... When you set yourself with a purpose, nothing can stand against you..." The 'HEALER' engages its readers with the biography of Dr Prathap Reddy, containing stories of his accomplishments, and traces his unbelievable journey from a small provincial town in Andhra Pradesh to Stanley Medical School, and his phenomenal success as a practicing cardiologist in the US, and his return to India at the age of 50, to bring medical care at par with the best. In her applauded speech, Dr Kiran Mazumdar-Shaw said, "India is a very young nation. We have a number of pioneers who are nation builders, who have a sense of purpose coupled with a spirit of challenge, because India is not an easy country to pioneer in."   "He (Dr Reddy) is a man on a mission. He was the one who looked at Indian healthcare in a different way. Every pioneer looks at a challenge as an opportunity. Dr Prathap stands for professionalizing healthcare and making passionate business model. He has shown the way to the rest of the healthcare industry in terms of what can be done to make a difference. He transformed the healthcare landscape in India," expressed Dr Kiran. Dr Kiran also shared that the government should ensure that every Indian has the right to healthcare, which is seen to be the next big challenge. In several instances, the book also recalls the state of affairs of Indian healthcare sector in the last forty years, oven along with mammoth challenges faced by Dr Reddy during his journey. In the book, Mr Gupte has also incorporated several interesting anecdotal stories, and twists and turns, narrating Dr Reddy's life story in a dramatic way. Dr Kiran concluded by adding, "Dr Reddy's rich legacy are his daughters. His wife has been a great pillar of support for the whole family. Here is a man that we salute with great admiration and gratitude. Thanks to you Dr Reddy, because this country is a better place now."   Priced at INR 899.00, HEALER is available at leading bookstores, and also in shopping portals and online bookstores. Product details:HardcoverPublisher: Portfolio (2013)Language: EnglishISBN-10: 0670086800ISBN-13: 978-0670086801   ]]> https://biospectrumindia.com/news/97/3693/kta-start-wins-prestigious-scientists-choice-award.html https://biospectrumindia.com/news/97/3693/kta-start-wins-prestigious-scientists-choice-award.html Wed, 12 Mar 2014 12:42:35 +0530 ÄKTA start, a compact, affordable and easy-to-use preparative chromatography system for laboratory-scale protein purification by GE Healthcare Life Sciences, a business unit of GE Healthcare (NYSE: GE), has been awarded the prestigious Scientists' Choice Award. ÄKTA start was announced as the winner of 'Best New Separations Product of 2013' award during a ceremony held at the Pittcon 2014 Conference and Expo in Chicago, Illinois, USA. The Scientists' Choice Award is conducted annually by SelectScience, an independent, expert-led scientific review resource for the worldwide scientific community. The awards enable scientists around the world to voice their opinions on the best laboratory products. This year's Scientists' Choice Awards attracted over 2,500 nominations and votes from scientists around the world. Kerry Parker, Editor-in-Chief of SelectScience, said, "We are delighted to recognize the new products that have made a real difference to laboratory work in 2013. We received a huge number of nominations and votes, which confirms what a successful year it has been for innovative laboratory products." ÄKTA start, launched in December 2013 is the latest addition to GE's new generation of ÄKTA systems and is the first Life Sciences product designed and developed by the company's research and development center in India, for the world. GE Healthcare has various products in medical technology innovation in India with over 125 product innovations and 25 complete products coming out of its John F Welch Innovation Centre, Bangalore. Anurag Gupta, managing director, Life Sciences, GE Healthcare, India, said, "This is truly an outstanding recognition for our solution. ÄKTA start breaks new ground as it improves affordability and helps to accelerate research and innovation not only in India but also globally. We are excited that scientists around the world have recognized the potential of this solution. We would like to thank those over 400 enthusiastic scientists and manual users who provided us feedback, insights and direction in designing this simple, easy to use protein purification system" Protein purification is a laborious process that isolates a single type of protein from a complex biological mixture, and is essential in developing bio-pharmaceutical drugs used in the treatment of diseases such as cancer, viral diseases and when developing vaccines. ÄKTA start helps researchers eliminate the hassle of manual protein purification, while providing automated control of the purification procedure. Its affordability will allow more researchers to take advantage of GE Healthcare Life Sciences' protein purification expertise and experience. ]]> https://biospectrumindia.com/interviews/97/3692/we-are-well-positioned-in-india.html https://biospectrumindia.com/interviews/97/3692/we-are-well-positioned-in-india.html Mon, 10 Mar 2014 16:22:00 +0530 After the takeover of New Delhi based biosupplier RFCL's business in 2011, the Avantor Performance Materials, a global supplier of high-performance chemistries and materials to the biopharmaceutical industries, has expanded its footprint significantly in India. Here are the excerpts of the recent interview with one of the company's top executive, Mr Paul A Smaltz. Q: It has been three years since the acquisition of RFCL by Avantor. How has it benefitted the company operations in India? The acquisition of  RFCL by Avantor has allowed the company to build a solid position in the Indian market as a supplier of high-quality, fully traceable regulated raw materials to the traditional small-molecule market, as well as the growing large-molecule segment. Thanks to excellent local management and logistics support from the RFCL team, Avantor was able to enter the market as a key supplier of multi-compendia cGMP-produced materials (current Good Manufacturing Practices) by initially importing its JT Baker brand products from the US to supply the fast-growing pharmaceutical market in India. Avantor then completed a state-of-the-art pharmaceutical raw material facility in Panoli, India, which began cGMP production in January 2013. This facility is ISO 9001:2008 registered; approved by the Indian FDA; and registered with the US FDA.   Avantor now sells its Macron Fine Chemicals brand products with Indian (IP), US (USP), European (EP) and Japanese (JP) Pharmacopeia specifications to major pharmaceutical companies in India out of this facility. Q: What are your areas of focus as far as product services to bioscience industry is concerned? Over the last year we have started to supply cGMP buffers out of our facility in Panoli, as well as other inorganic salts that are used throughout the process of manufacturing large-molecule therapeutics and vaccines. We are very excited about the developments in India around the manufacturing of biologics, and this is a big focus for Avantor. We just launched the JT Baker line of Super Refined polysorbates that enhances stabilization of the API in the finished dosage. This product is being formulated into new biologics as well as small-molecule parenterals with great success. Q: In Indian context, what are the major challenges and opportunities in the biosupplier business? Many of the pharmaceutical facilities in India are doing contract manufacturing, or doing runs for clinical trials. This makes it difficult to forecast their demands for raw materials. They need material quickly, with little lead times, to be able to keep to their production schedules. By producing the key processing agents and excipients in India, Avantor is able to respond quickly to the needs of our customers in India. Q: Please tell us about your interactions with clients in India. Whether there are any new changed trends you witnessed while serving them?   Many Indian companies are producing for the global market now and must upgrade their raw materials and excipients from meeting only IP requirements to also meeting USP, EP and JP requirements, so that their products can be marketed throughout the world. Avantor is uniquely qualified to help our customers in India with this growing need through cGMP-produced materials out of our Panoli plant, which is not only approved by the Indian FDA, but is also registered with the US FDA. Q: How have your financial results from India been in the last one year? What were the revenues in your last fiscal year? How is the current year expected to be? As a privately held company, Avantor does not release or discuss financial results publicly, but with the advantages we have through our facility in Panoli we have done quite well. As we get into 2014, we are even more optimistic for our results out of India. Not only do we see significant new business within India as more qualifications are completed with our customers there, but we are now beginning to export product out of India to the rest of the world. Q: What kind of future outlook do you have for your company, as well as the industry? We see strong growth. We are well-positioned in India for the growth of large-molecule therapeutics and vaccines. We still see a lot of innovation, not only in the new drug pipeline but in manufacturing processes. The changes in the manufacturing processes affect what raw materials are used and how they are packaged, including pre-weighed buffers and additives in bio bags. Avantor is working with customers across the world to provide products in a more customized format that helps take cost out of the drug manufacturers' processes. As a supplier to the world's leading large-molecule therapeutic manufacturers, Avantor is prepared and committed to help customers in India and around the world to optimize their processes to improve yields and remove costs. ]]> https://biospectrumindia.com/features/97/4857/cleanroom-consumables-market-to-exceed-8-billion-in-2015-.html https://biospectrumindia.com/features/97/4857/cleanroom-consumables-market-to-exceed-8-billion-in-2015-.html Fri, 07 Mar 2014 17:27:00 +0530 The global cleanroom market consists of a plethora of consumables and hard ware products carrying phenomenal precision and quality. The biotech and pharmaceutical sectors require cleanrooms and controlled environments which need to control the concentration of airborne particles, micro-organisms, temperature, humidity, and pressure. The cleanroom trends began in the area of medicine and research where experts saw a close relationship between hygiene and manufacturing quality products. As Indian pharmaceutical and biotechnology industry faces stringent manufacturing and export regulations from Indian and foreign regulatory bodies, companies now are seeking to match up with superior quality in their manufacturing processes, and the demand for cleanrooms is now catching up far more than ever before. Says Mr P Pradeep, CEO, Whitenair Technologies, "Cleanroom technology has great demand in the biotech sector and is growing day-by-day. The sector is involved in multiple activities such as safety laboratories, production units, bio-exclusion, and animal supply facility to name a few. Cleanrooms and controlled environment play a crucial role in the bio technology industry." In 2014, McIlvaine predicted that there will be 131 million sq.ft of cleanroom space in use across the world. This is an increase of five percent in 2013. It also states that in 2013, the pharmaceutical industry employed 2.3 million people in the cleanroom industry, which can jump to 2.4 million by 2015. In terms of cleanroom consumables, Asia is projected to be the largest hub by 2015 witnessing growth in consumables and hard ware products.    A press release published by McIlvaine in 2012 predicted that the cleanroom consumables market would reach $7 billion in 2013 and may exceed $8 billion in 2015. The pharmaceutical and biotechnology sector is expected to be the third largest consumers of clean room products. On the other hand, the cleanroom hardware sales are estimated to be $4.9 billion this year. Asia is considered both, the largest and fastest growing region for clean room hardware and consuamables. The pharmaceutical industry continues to show steady growth mostly taking place outside the US and Europe. However, pharmaceutical and hospital markets are much larger in the US and Europe than in Asia. The semiconductor industry paved the way of mini environment concept, which is now widely adopted by the pharmaceutical industry, led by contract manufacturers. Global pharmaceutical contract manufacturing market clocked revenue of $13.43 billion in 2012, according to analyst firm Frost and Sullivan, and the market is expected to reach $18.49 billion in 2017. According to market analysis firm, Vision gain, the global market for pharma contract manufacturing is estimated to have expanded by five percent in 2013. According to the analysis firm, pharmaceutical companies' urgency to focus on their core competencies of research and development and expiring blockbuster drug patents is driving the need to outsource pharmaceutical manufacturing.   Pharmaceutical and biotechnological emphasis on complex disease areas, trends in disease control, growth in emerging markets, and reformulation of existing products have widened the scope of the contract manufacturing market. Contract manufacturing is expanding in the areas of solid dose, liquid and semisolid dose and injectable dose formulations, according to a report by Frost and Sullivan. "Investments and capacity expansions in the inject able dose formulation segment are in the near future, as it is likely the most significant source of income for the global pharmaceutical contract manufacturing industry," said Ms Aiswariya Chidambaram, healthcare research analyst, Frost & Sullivan. "Cytotoxics manufacturing, in particular, offers immense growth potential, given the demand from the cancer research and therapy segments." According to industry reports, the US and Europe are major markets for outsourcing finished dose formulations and sterile preparations and Asian CMOs are preferred destinations for active pharmaceutical ingredients, intermediates and generics. Countries like India, China and Taiwan have been providing cost benefits to global pharmaceutical industry and would continue to be preferred destinations for solid dose formulations. Contract manufacturing allows pharmaceutical companies to transfer noncore activities to external partners, leverage their own resources and focus on strategies for future growth. Even pharmaceutical companies are not shying away from creating their own contract manufacturing wing that embarks on the opportunities of outsourcing services. Pfizer, for instance, has revealed its plan to win contracting work for its hormone plant in Sweden and may Global even include molecule drugs for its own competitors. The pharmaceutical industry is considered as the number one major cleanroom hardware purchaser. On the other hand, the semiconductor industry is considered to be the largest user of cleanrooms worldwide. Under consumables, gloves are the most purchased cleanroom consumable in the world, followed by wipes and disposable garments. Other widely purchased consumables include disinfectants and cleaning solutions, mops, and special pens. Cleanroom hardware includes ceilings, floors, modular rooms, HVAC, mini environments, and instrumentation.   According to experts, the healthcare industry offers greater potential for consumption. Cleanrooms in bio pharmaceutical manufacturing plays crucial role in the manufacturing processes at the same time keeping in mind low-cost and environmental friendliness. When designing cleanrooms, it is crucial to stick to stringent requirements of regulatory body such as FDA, WHO, cGMP, and URS (User Requirement Specification). Asian countries provide a significant cost advantage for pharmaceutical manufacturing accounting for almost 50 percent cost reduction as compared to that in Europe or USA. India, in particular, is an attractive destination as it has a strong pool of qualified and skilled manpower with the knowledge to operate manufacturing facilities. In India, there are more than 100 FDA approved pharmaceutical facilities, the largest number of sites outside the US. China and Taiwan are also gearing up to build more regulatory approved manufacturing sites that win confidence of the companies to outsource production services. "Implementation of new technologies such as Variable Frequency Drive (VFD) to control the plug fan of an AHU, adopting IVRF air conditioning system to reduce operational cost along with cleanroom monitoring systems, which includes particle counting, controlling temperature and humidity for different zones are highly recommended," adds Mr Pradeep. In January 2013, GEF South Asia Clean Energy Fund invested $8.4 Million in Integrated Clean Room Technologies (IClean), a provider of turnkey cleanrooms and associated equipment to biotechnology, pharmaceuticals and microelectronics sectors.   As cleanrooms consume large amounts of power, the need for incorporating and introducing cleanroom smart technology is also the need of the hour to cut exorbitant costs. However, Mr Pradeep feels that the cost of instilling cleanrooms do not have any impeding effect on clean room industry. "Most of the customers realize the advantage of having quality products and are sticking to the compliance of regulatory bodies like cGMP,WHO, and US FDA. Hence, implementation of cleanrooms has become an integral part of the quality process," he expressed. According to Mr Robert W McIlvaine, president, McIlvaine Company, the cleanroom industry is now accelerating forward because of intense activities taking place in China in the area of cleanroom technologies. "Over the next decade, China will become the largest consumer of cleanroom products as well as one of the largest sup- pliers," he said in a report. Commercial survivability of a company is largely decided by the quality of products it produces. A cleanroom ensures production of products with high quality, adding to the overall success of any company.                                By Raj Gunashekar with inputs from Amrita Tejasvi ]]> https://biospectrumindia.com/news/97/3156/mahajan-imaging-gets-indias-first-silent-mri.html https://biospectrumindia.com/news/97/3156/mahajan-imaging-gets-indias-first-silent-mri.html Tue, 25 Feb 2014 18:43:48 +0530 Mahajan Imaging, Delhi is the first healthcare facility in Asia to install Silent MRI in India. GE's exclusive Silent Scan technology is designed to reduce MR scanner noise to near ambient (background) sound levels and thus improve a patient's MR exam experience. Conventional MR scanners can generate noise in excess of 110 dBA (decibels) levels, roughly equivalent to rock concerts. "One drawback of MRI scans is that they are loud, generating as much noise as a rock concert or an airplane engine. Noisy MRI scans can be quite disturbing, especially brain scans in elderly and children, and hence, since patient comfort is paramount for getting accurate, high-quality images, sometimes we need to repeat scans to get high quality images. With this new Silent MRI, we are able to get exceptionally high-quality images of the anatomy the first time, since MRI noise is virtually inaudible and the patient is relaxed. This is in-line with our mission of bringing the latest and most-advanced medical technologies into the country." said Dr Harsh Mahajan, director, Mahajan Imaging, a Padmashri awardee. Noise is one of the major complaints from patients who undergo a MRI exam. Historically, medical manufacturers have addressed the noise issue by muffling it using a combination of acoustic dampening material or even degrading MRI machine performance in order to reduce the noise level. Two years ago, GE engineers initiated their quest to reduce noise during an MRI scan. They developed -Silent Scan Technology, a radical new type of 3D MR acquisition methodology, a combination of proprietary high-fidelity gradient and RF system electronics, by which the noise is not merely dampened but is virtually eliminated at the source. The Silent Scan Technology is co-developed in India by GE. "Silent MRI puts patients first. It is part of our efforts to humanize MRI systems and make them patient friendly and safe without compromising on image quality. The Silent Scan technology is co-developed in India by our engineers. While it is a boon for patients, it also potentially allows a healthcare facility to see more patients with fewer repeat scans or recalls." said Dr Karthik Kuppusamy, senior director, MRI Imaging, GE Healthcare South Asia. Silent Scan is available on new as well as existing Discovery MR750w with GEM and Optima MR450w with GEM systems. ]]> https://biospectrumindia.com/features/97/7753/bioasia-2014-innovation-collaboration-identified-as-success-keys.html https://biospectrumindia.com/features/97/7753/bioasia-2014-innovation-collaboration-identified-as-success-keys.html Tue, 25 Feb 2014 17:56:00 +0530 The guests of honor comprised of Dr Lino Baranao, Hon'ble Minister, Ministry of Science & Technology, Argentina; Mr Kim Sang-Pyo, Hon'ble Vice Governor, Gangwon Province, Republic of Korea; Dr Antonio Juan Bonfatti, Hon'ble Governor, Santa Fe, Argentina; Mr Patrick Suckling, Hon'ble Australian High Commissioner; and Mr Andrew McAllister, Hon'ble British Deputy High commissioner. During the inaugural ceremony, Dr K V Raghavan, chairman of BioAsia's organizing committee, scientist and emeritus and former director, Indian Institute of Chemical Technology, Hyderabad, said, "The decade saw an outstanding success in attracting international partners, breaking innovation and business opportunities at the doorsteps of biotechnology industry in India. Over 60 percent of the participants here are from pharmaceutical and biotechnology companies and 15 percent of them are CROs and CMOs."   The key note was delivered by Mr G V Prasad, chairman and CEO, Dr Reddy's Laboratories, and Mr Chris Stirling, global head, life sciences, KPMG, UK. Mr Andrew McAllister in his speech added, "We will be exploring opportunities in the life sciences sector, sharing knowledge and conducting businesses. This is an auspicious start. The UK's relationship with India at social level is of tremendous importance. The Indian diaspora is larger than any other minority community in the UK. The Indian life sciences is engaged in world-class work." Mr McAllister recalled that Andhra Pradesh has a good infrastructure which attracts investors from all over the world. "UK life sciences companies are well represented in India. The R&D fair in national labs and in various life sciences clusters in Bangalore, Ahmedabad, Mohali and Hyderabad are building ecosystem needed for drug discovery and innovation in life sciences," added Mr McAllister. For the UK, according to Mr McAllister, the life sciences is a priority. "The commitment directly comes from the UK's Prime Minister's office. There is wider focus on getting more investor in this sector. We have four of the world's leading Universities and a well-established sophisticated R&D manufacturing and supply chain ecosystem," he said.   He believes that the government, academia, and industry can ensure the practical applicability of pure sciences to develop high-end products, whose benefit can be shared nationally and internationally. "The UK is a great place to conduct efficient R&D. Research and knowledge transfer is increasing internationally. We want to internationally bring the best-in-the-world researchers and access international facilities, which is the basic foundation for success and the relationship between India and the UK is significant. By combining our strengths and ideas, our chances of success increases exponentially. We in the UK offer an environment that welcomes companies and steer them through and help find suitable partners," he opined. Mr Patrick Suckling in his speech commented, "The key message from the Australian government is that it is committed to do business-friendly activities. Its continuing economic refocus has made Australia a global performer for the last few decades. India is our fifth largest export market. Indian companies are investing in Australia and about $10 billion went in to our economy last year from companies, including GVK and Tech Mahindra." Mr Suckling emphasized that Australia serves as an attractive business partner for varied reasons. "We have a strong ecosystem and a proven track record. We are committed to R&D. Australia is strategically located composed of multi-cultural workforce. India stands as the second largest group of people in Australia. Our country is well positioned with strong R&D base, which is mutually beneficial to the people of India and Australia," he explained.   In his keynote address, Mr G V Prasad added, "Innovation is an over-used word. We have moved to knowledge-era where IP and creating winning ideas and the power of ideas drive value creation. We have to focus and build our research in academic institutions and remove barriers to attract global talent. We should increase global capita, be tolerant to failures, and design and implement policies to enable innovation in biotechnology." He further added, "With achievements in the biotechnology, we can help our farmers much. Without biotechnology, we would have had large famines in our country. We can leverage this technology to reduce harmful effects of pesticides. This is good for the climate and sustainability." Talking about the advances in genomics, Mr G V Prasad added, "Genomics has resulted in personalized medicine, gene therapy, predictive diagnostics, bone replacement and growing organs through stemcells." "And, by sharing clinical data and medical records, and applying tools on the big data, we can understand diseases well and develop much better medicines," he commented. India is said to be the largest producer of vaccines in the world. "This is possible because of the strong drive in the innovation and positive support from policy-makers. Drugs from India is helping countries lower their budgets. We have been keeping prices lower to make them accessible to all sections of the society. We have helped South America and Africa to tackle AIDS, and provide vaccines to the world across various geographies. Innovation has made this possible for making alternate versions of products discovered elsewhere at better costs," emphasized Mr Prasad.   He continued stating that, "We do not patent cutting-edge innovative products yet in the life sciences and IT industry. We have helped other countries innovate. It is time for us to bring these skills together and move to the highest kind of innovation in the value chain." According to Mr Prasad, innovation amounts to 70 percent of the value chain today. "To address this, we need to fix higher education in research institutions and universities and increase access to risk-capital and be tolerant of failures and support government policies." Commenting on India's existing turmoil in the area of clinical trials, he stated, "Clinical trials in India is not easy. It is extremely complex and hard to get clearances. Investors are looking for short-term and immediate profits. This has to be addressed if you need to pursue innovation to make innovative products." "With emphasis on higher education and research in universities, high risk-capital, tolerant to failures, supportive governmental policies, we can get there," he summarized. Another keynote speaker, Mr Chris Stirling, expressed that the current industry model doesn't put patients at the heart of its decision-making. "Judgments are influenced by developments and block-buster products, which are expected to drive block-buster returns for shareholders," he said.   Mr Stirling also was heard quoting the New England Journal of Medicine that, "Over 50 percent of the drugs have not demonstrated any tangible patient benefits." He also commented that, "Putting patients in the center will move the industry. About 90 percent of the healthcare budget is spent on services and infrastructure, and only 10 percent is spent on drugs. Mr Stirling advised by saying, "Companies need to implement three fundamental steps. First is to promote new business models since traditional research model is not working as it used to be. The return on R&D has fallen from the industry's average of 20 percent twenty years ago, to an average of 10 percent now. Secondly, prioritizing patients' perspective is important to better understand patients, which allows development of innovative patient-centered treatments. Research should address the patients' needs and not just symptoms. Thirdly, we need to foster a culture of collaboration, since it is just as important as innovation." He concluded by opining, "The healthcare landscape is changing everywhere and life sciences companies need to realize that. Life sciences is global in nature but healthcare systems are local. The game is changing. Finding solutions to succeed in this new landscape is not easy. A lot of innovation is required which is focused on patients." Countries that participated in the BioAsia 2014 included China, Singapore, Sri Lanka, Pakistan, Iran, US, Scotland, Australia, and Belgium.   The principal country partner for this event was UK and the international state partners included Santa Fe province of Argentina and Gangwon of South Korea. The event was organized by Federation of Biotech Association, Pharmaceuticals Export Promotion Council (Pharmexil) and Government of Andhra Pradesh. (Raj Gunashekar in Hyderabad, Andhra Pradesh.)   ]]> https://biospectrumindia.com/news/97/4017/agilent-introduces-breakthrough-icp-ms-and-mp-aes-platforms.html https://biospectrumindia.com/news/97/4017/agilent-introduces-breakthrough-icp-ms-and-mp-aes-platforms.html Mon, 24 Feb 2014 13:16:00 +0530 Agilent Technologies Inc has recentlyintroduced the 7900 Inductively Coupled Plasma - Mass Spectrometer (ICP-MS) and the 4200 Microwave Plasma - Atomic Emission Spectrometer (MP-AES), the latest in a series of groundbreaking technologies featured in Agilent's portfolio of spectroscopy solutions. The 7900 ICP-MS and 4200 MP-AES are the most sophisticated, user-friendly elemental analysis technologies available today. Newly streamlined operational features also make them ideal for a wider range of challenging applications and more accessible to a broader spectrum of laboratory personnel. "At Agilent we continue to introduce 'new to market' technologies across our platforms, enabling our many customers to expand their labs' capabilities and simplify their workflows," said Philip Binns, Agilent vice president of spectroscopy products. "The introduction of the 4200 MP-AES and 7900 ICP-MS further demonstrate our leadership position in elemental analysis and our commitment to providing our customers with the best tools to meet their application needs." 7900 ICP-MS: A New Standard in Quadrupole ICP-MS Performance "The 7900 ICP-MS redefines the way we analyze samples by extending the application range significantly," said Wim Proper, development analyst, Eurofins Analytico. "With its unprecedented ultra-high matrix capability, the 7900 allows us to easily switch between trace element analysis of demineralized water to high total dissolved solid digests all in the same sequence." The 7900 ICP-MS is a complete redesign, sharing only a few key components from the world's bestselling 7700 Series. The 7900 has been engineered and optimized to provide elemental laboratories with the industry's most powerful and easy-to-use quadrupole ICP-MS solution. Features include: Unprecedented matrix tolerance - Ultra-high-matrix introduction technology enables laboratories to measure samples containing up to 25 percent total dissolved solids, 10 times higher than the current benchmark held by the 7700 ICP-MS limit. This enables direct measurement of sample types previously inaccessible by ICP-MS. Enhanced trace-level detection - A novel interface design, optimized expansion-stage vacuum system and new orthogonal detector system (ODS) reduce background and improve sensitivity, dramatically improving signal to noise for 10-fold lower detection limits than any quadrupole ICP-MS system available today. Widest dynamic range of any quadrupole ICP-MS - Patented ODS technology delivers up to 11 orders of magnitude dynamic range, from sub-ppt to percent-level concentrations, which enables users to measure trace elements and majors in the same run. An industry-first capability, this eliminates analyte-specific tuning and simplifies method development, virtually eliminating over-range results. Redesigned MassHunter software features a simpler, more intuitive user interface along with powerful method automation capabilities. Another industry first, the new method set-up wizard makes method development easier than ever, automatically building methods based on answers to a simple user questionnaire. 4200 MP-AES Series: A Novel Breakthrough in Entry-Level Elemental Spectroscopy Technology "The 4200 MP-AES, the latest advancement in Agilent's broadly used microwave plasma-atomic emission spectrometer series, provides the safest, most expansive yet cost-effective elemental analysis capabilities compared with any other entry-level atomic spectroscopy technology," said Agilent's Keith Bratchford, general manager, Atomic Spectroscopy Products. The 4200 MP-AES features a variety of unique capabilities: Safe and economical - Because flammable and oxidizing gas sources are not required for use, the system can be left unattended while performing overnight multi-element analysis, which dramatically increases laboratory safety and flexibility and reduces operating costs compared to Flame AA. Robustness and reliability - Optimized high-performance waveguide and new torch design produces a robust nitrogen plasma, which enables greater tolerance to complex matrix samples such as those used in mining, food and agriculture, chemicals, petrochemicals and manufacturing. Mass flow control of the nebulizer gas enhances accuracy and long term stability in complex samples. Ease of use - Application-specific software applets plus plug-and-play hardware ensures that with just minimal training, any user can quickly and easily conduct analyses without the need for method development or alignment. Advanced software platform - Newly released MP Expert software features advanced tools such as "FLIC" and IECs for assisting in eliminating spectral interferences. Mobile and remote capabilities - With no external cylinder connections and no need for ongoing gas supplies, the MP-AES is ideal for any elemental analysis laboratory-especially remote sites and mobile laboratories. This eliminates the need to plumb multiple gasses into the laboratory or manually transport and handle hazardous gas cylinders. ]]> https://biospectrumindia.com/news/97/7584/agilent-ms-purification-wins-analytical-scientist-innovation-awards-.html https://biospectrumindia.com/news/97/7584/agilent-ms-purification-wins-analytical-scientist-innovation-awards-.html Mon, 24 Feb 2014 12:04:55 +0530 Agilent Technologies Inc. (NYSE: A) announced that the 1260 Infinity Automated LC/MS Purification System, launched in late December, was one of the winners in the Analytical Scientist Innovation Awards. The automated solution, which builds on ultra-high performance liquid chromatography/mass spectrometer detection, was cited as one of 15 transformative technologies introduced in 2013 for its ability to synthesize pure compounds without tedious method development or scale-up work. "The Analytical Scientist Innovation Awards showcase the extraordinary range and pace of progress in our field, and we extend our congratulations to everyone involved in the development of these innovations," said Analytical Scientist editor Mr Rich Whitworth. Referencing the system's optimal performance, efficiency and affordability, the publication detailed how the 1260 Infinity Automated LC/MS Purification System enables scientists to rapidly and easily confirm successful synthesis of target compounds in a matter of minutes, without any calculations, method translation or "vague guesses" about optimum conditions. Without in-depth training on preparative chromatography, chemists, biologists or engineers can finally benefit from state-of-the-art separation efficiency. Specialized chromatographers can move away from routine purification work to focus on truly difficult separations. "We are honored that the 1260 Infinity LC was selected for the Analytical Scientist Innovation Award," said Mr Patrick Kaltenbach, vice president of Agilent's Liquid Phase Division. "This automated UHPLC/MS solution is a milestone for our customers looking for thoroughly automated purification capabilities." The 1260 Infinity Automated LC/MS Purification System is a scalable, workflow-focused solution for drug discovery and agrochemical research. Built on robust 1260 Infinity UHPLC and preparative HPLC modules and proprietary software algorithms, the system provides superior purification with automated delay volume calibration, and focused gradients tailored on the fly to individual target compounds. The 1260 Infinity was one of two Agilent products to be named among the Analytical Scientist's top 15 transformative technologies of 2013. The company's GC-MS Inert Flow Path Solutions technology was ranked No. 10. On September 19, 2013, Agilent announced plans to separate into two publicly traded companies through a tax-free spinoff of its electronic measurement business. The new company is named Keysight Technologies, Inc. The separation is expected to be completed in early November 2014. ]]> https://biospectrumindia.com/news/97/3600/agilent-introduces-liquid-chromatography-systems.html https://biospectrumindia.com/news/97/3600/agilent-introduces-liquid-chromatography-systems.html Fri, 31 Jan 2014 13:42:00 +0530 Agilent Technologies has introduced the third version of its Intelligent System Emulation Technology for the 1290 Infinity Binary LC and 1290 Infinity Quaternary LC systems. The new ISET version allows emulation of the Waters Acquity UPLC and Acquity H-class systems and the Shimadzu Prominence HPLC system. ISET provides a seamless transfer of methods between varying LC technologies, delivering unchanged retention time and peak resolution. The 1290 Infinity LC is now the world's most adaptive LC system, as it can execute other HPLC and UHPLC methods and deliver the same chromatographic results without any instrument or method changes. The 1290 Infinity LC together with ISET allows users to: · Emulate other (U)HPLC instruments with a simple mouse click· Run existing (U)HPLC methods without modifying method or system· Deliver same retention times and peak resolution for -enhanced method transfer "ISET enables highly regulated laboratory environments, such as pharmaceutical quality control, to globally transfer methods between different instruments," said Christian Gotenfels, Agilent's senior product manager for liquid chromatography. "With this unique technology we are addressing a major gap in the workflow of our customers." ]]> https://biospectrumindia.com/news/97/6985/bd-diagnostics-introduces-system-for-infection-detection.html https://biospectrumindia.com/news/97/6985/bd-diagnostics-introduces-system-for-infection-detection.html Mon, 13 Jan 2014 16:47:29 +0530 BD Diagnostics, a segment of BD (Becton, Dickinson and Company), introduced the BD BACTECTMFX 40 Blood Culture System for the detection of bloodstream infections. This new system improves clinical decision-making and laboratory workflow by markedly improving blood culturing practices with real-time, remotely accessible, actionable results that can enhance patient care. One of the critical concerns & declared medical emergency worldwide is Sepsis. In India, published data shows that the ICU-specific mortality with sepsis is around 27%, 32% in patients with severe sepsis, and 50% to 70% in patients with septic shock. Reports say that every hour of delay in the appropriate treatment increases the mortality rates by 7.6%. Blood cultures are clinically critical and recommended for faster and superior diagnosis for sepsis. With a compact and versatile system design, future upgradability & latest technology, the BD BACTECTM FX40 Blood Culture system is modular and affordably-priced system that offers customers to expand their workload over time through the modular capability of the instrument. "This new addition to the FX family of BD Diagnostics will further enhance clinical decision-making and laboratory workflow by its innovative technology & design" says Punit Kohli, business director, BD Diagnostics, India. It is the result of 40 years of blood culturing expertise and customer interaction, with more than 10,000 blood culture instruments installed worldwide. The system utilizes the breadth of current media containing our well established resin technology that provides unmatched recovery of pathogens from the blood. The BD BACTECTM FX system maintains the proven high performance and instrument reliability of the BACTEC series representing excellence in blood culture isolate recovery, along with exceptional instrument and media performance. BD has also pioneered the RESIN technology for blood culture media which offers significantly superior time to detection and antibiotic naturalization capability. ]]> https://biospectrumindia.com/news/97/5171/ge-acquires-thermo-fishers-assets-for-1-06-billion.html https://biospectrumindia.com/news/97/5171/ge-acquires-thermo-fishers-assets-for-1-06-billion.html Tue, 07 Jan 2014 16:48:00 +0530 This acquisition will allow GE to expand its offering of technologies for the discovery and manufacturing of innovative new medicines, vaccines and diagnostics in its growing life sciences business. GE's acquisition is in direct alignment with its strategy to invest in high-technology and innovative businesses. Mr John Dineen, president and CEO, GE Healthcare, said, "Life Sciences is one of our strongest and fastest-growing business areas, driven by the world's demand for improved diagnostics and new, safer medicines. Combining GE's engineering expertise with our capabilities in life sciences is already bringing great benefits to industry, research and patients. This deal makes a good business even better and will help us realize our vision of bringing better healthcare to more people at lower cost." GE Healthcare in a press release said that this new alliance will accelerate the development of innovative "end-to-end" technologies for cell biology research, cell therapy and manufacture of innovative biological medicines and vaccines. Mr Kieran Murphy, president and CEO of GE Healthcare's Life Sciences division, said, "We look forward to the HyClone cell culture and other businesses joining the GE family. They are a great fit with our key areas of focus, and bring exciting new technologies, enhanced manufacturing capabilities, and as well as a great group of talented people to help grow our business." He further added, "In addition to providing us with new approaches to drug discovery and biomedical research, this acquisition is a significant step forward for our customers in biopharmaceutical manufacturing. They will benefit immediately from an expanded range of 'start-to-finish' technologies that will help them improve product yields and reduce time-to-market."   GE's acquisition of the businesses is anticipated to close in 2014 after receiving necessary regulatory approvals. The three acquired businesses combined annual revenues were approximately $250 million in 2013 said the press release on Monday.   ]]> https://biospectrumindia.com/news/97/4376/biospectrum-announces-hits-and-misses-of-2013-a-flash-back.html https://biospectrumindia.com/news/97/4376/biospectrum-announces-hits-and-misses-of-2013-a-flash-back.html Mon, 06 Jan 2014 16:33:00 +0530 The Indian BioScience industry witnessed tremendous highs and lows in 2013. Specifically, the pharmaceutical industry took most of the beating, owing to regulatory woes within the country and import bans from foreign bodies. However, in terms of new innovation and products developed, India made many heads turn in the global market towards itself. Major collaboration and acquisitions were a continuous integral part of many Indian companies. Here is an exclusive sneek-peek of the significant events in 2013: Cabinet nod for establishment of National Cancer Institute  Being set up at the cost of Rs 2,035 crore, the National Cancer Institute (NCI) is expected to cater to requirements in northern India. This is a landmark step in the arena of cancer research in the country and shall lessen the deficit of tertiary cancer care in the Northern region. Cancer is emerging as a major public health concern in India, where every year 11 lakhs new cases are diagnosed, with a mortality rate of 5.5 lakhs per year. Shackled in India, Bt Brinjal gets free run in Bangladesh  While the Bt brinjal issue in India continues to remain tangled in the political and legal systems, Bangladeshis have decided to take the plunge. It may sound positive for the industry, activists feel otherwise. The top regulatory authority in Bangladesh, the National Committee on Biosafety (NCB), has given its approval in November, 2013, to the commercial cultivation of the Bt brinjal, making it the country first in South Asia to allow the entry of any edible genetically modified (GM) crop in its market. Doctors to receive real time medical updates With the introduction and implementation of remote access informationdevices that are accessible and has the ability of interoperatibility from any remote place and transmit data at any given time will result in saving lives in case of emergency situation. Prisma Global limited introduces a product called Medibox or MDS3. GE Healthcare to invest $2 bn in software development GE Healthcare announced its plans to invest $2 billion over the next five years to accelerate the development of innovative software for healthcare systems and applications. Over next five years, the company will focus on advancing current and future technology offerings through the convergence of machine and intelligent data known as the industrial internet. It is the age of 'Digital Patient', says Quintiles A new report by Quintiles has indicated that sponsor companies that can successfully engage with the digital patient will distinguish themselves and increase their probability of success. Quintiles has suggested that aligning activities such as patient recruitment, collection of medical data with the digital environment will streamline product development, prove product value and accelerate product adoption. UK partners with BioAsia to bolster ties in biotechnology On November 29, 2013, the United Kingdom partnered with BioAsia as the Principal Country Partner for the 11th edition of the event, BioAsia 2014, to be held in Hyderabad from February 17-19, 2014, at the Hyderabad International Convention Centre. Novozymes opens world's first advanced biofuels facility in Italy  On October 9, 2013, Novozymes and Beta Renewables officially opened the world's largest, second-generation biofuels facility in Crescentino, Northern Italy, estimated to produce 75 million liters of cellulosic ethanol annually, from agricultural waste. Beta Renewables is a leader in producing cellulosic biofuels and a part of the Mossi Ghisolfi Group, and Novozymes. Indian government backs generic drug industry In light of the controversy regarding the quality of generic drugs produced in India, the government has issued a statement that supports the industry whose majority exports are to regulated markets and is 4th in the world in terms of production. The Government of India has come forth with an assurance about the drugs being manufactured in India being subject to scrutiny by various agencies. FDA finds hair, oil spots on tablets at Ranbaxy's unit Last year, during USFDA's visit to Ranbaxy's Laboratory facility, inspectors found a black 'hair' particle in a tablet, possibly suspected to have fallen from an employee's arms. Post this incident, the USFDA became highly alert and imposed an import alert on its Mohali plant, stating that the drugmakers manufacturing units were not up to the industrial standards. India pharma receives highest FDI worth $1 billion The Indian pharmaceutical industry has received US $1 billion as FDI (Foreign Direct Investment) - the highest among top 10 segments, during April-June this year. Back in April-June 2012, the Foreign Direct Investment (FDI) in the drugs and pharmaceutical industry was at $465 million, according to the latest data of Department of Industrial Policy and Promotion (DIPP) Dr Reddy's Laboratories sued over cancer drug patent Sanofi-Aventis' fully owned subsidiary - Genzyme Corporation, has filed a suit against Dr Reddy's Laboratories, alleging that it has infringed on patents of its cancer drug Mozobil (Plerixafor injection) on three counts.   Praj becomes first to set up 2G cellulosic ethanol plant South Asia's first second generation cellulosic ethanol demo plant by Praj Industries, will enable development of the entire value chain including biomass impact on the captital as well as operational. The demo plant will enable Praj to consolidate its 6 years of R&D efforts, starting with laboratory trials to pilot scale trials. The same plant will also enable Praj to develop various biochemicals and bioproducts.   Biocon ranked 6th in top twenty biopharma employers list On October 25, 2013, Biocon Ltd, announced that it has been ranked at 6th position by Science Magazine, on the annual global 'top twenty employers' list in the biopharma sector. This is a major leap for the company from its 19th place in 2012. Ranbaxy receives CDSCO approval to market Synriam in India Ranbaxy Laboratories has received approval from CDSCO to manufacture and market Synriam (arterolane maleate and piperaquine phosphate tablet 150+750 mg) in India. Strides Arcolab receives USFDA approval for its Italian facility Strides Arcolab announced that it has received USFDA approval for its Beltapharm's facility (a subsidiary of Strides Arcolab) located in Milan, Italy. This state-of-the-art, EU and TGA (Therapeutic Goods Administration, Australia) approved facility located in Milan, Italy, manufactures liquids, semi-solids, ointments and creams. MSD and Lupin announce strategic partnership In an important development, MSD, one of the world's starring players in 23-valent Pneumococcal Polysaccharide Vaccines category, and Pharma leading Lupin Limited (Lupin) today announced the forming of an India-specific strategic partnership. A recent survey from India showed that the case fatality rate due to invasive pneumococcal disease observed in elderly is 26.4% which is much higher than that in children and highlights the demand for preventive interventions in adults. Cipla India takesover Medpro South Africa  Cipla has announced an offer to the shareholders of Cipla Medpro South Africa to acquire 100% of the ordinary share capital of Medpro for $1.13 per share. The offer will be implemented via a scheme of arrangement and is subject to regulatory and other approvals including approval by Medpro shareholders. The total consideration payable by Cipla is approximately USD 512 million. Bharat Biotech develops indigenous JE vaccine  Said to be much effective and safe over attenuated vaccines against Japanese encephalitis disease, Bharat Biotech's JENVAC has proved its long term protection ability during clinical studies. The vaccine was launched at New Delhi on October 04, 2013. The biggest advantage of JENVAC over live attenuated vaccines is that this vaccine could be administered even during an epidemic as it is an extremely purified and inactivated vaccine. Monsanto faces biopiracy case India's first ever biopiracy case has been filed in Karnataka against Monsanto by ESG (Environment Support Group), a non-profit organization involved in environmental and social justice, for infringing the country's Biological Diversity Act. It is alleged that endemic varieties of Brinjal were accessed by UAS (University of Agricultural Sciences), Monsanto and Mahyco. After which, Monsanto's proprietary Bt Gene were inserted in the local varieties of Brinjal to create the Genetically Modified Bt Brinjal. India faces shortage of Yellow Fever vaccine While India is free from Yellow fever disease, the citizens traveling to affected countries have to be immunized. In view of the interruption of regular supply from CRI, K and anticipating the crisis situation, Sanofi Pasteur (the only company which has DCGI approval, but for single dose vaccine vial) was approached for supply of 60,000 doses (10 dose vial) in April, 2013. It was mentioned that, Sanofi Pasteur does not have license for multi-dose vial, it will have to get DCGI approval for Govt of India supply order. ]]> https://biospectrumindia.com/news/97/4000/ul-certifies-forus-ophthalmic-pre-screening-device-for-global-markets.html https://biospectrumindia.com/news/97/4000/ul-certifies-forus-ophthalmic-pre-screening-device-for-global-markets.html Fri, 13 Dec 2013 12:14:00 +0530 To help Indian small and medium enterprises (SMEs) achieve access to global markets, UL, a worldwide leader in advancing safety, announced that Bangalore-based medical devices startup, Forus has been issued the prestigious ISO 13485 certification. The standard ensures compliance of various aspects of a product lifecycle that affect safety and effectiveness of medical devices, including product design, prototype, manufacturing, installation, service and market surveillance of installed products. This enhances the credibility of Forus regulated markets, kicking off Forus' endeavor to penetrate markets outside India. The medical device sector in India is witnessing a surge of start-ups keen on addressing the huge gap in healthcare access, and increasing their revenue potential from global markets. UL works with over 70 SMEs and start-ups in this sector. "We are delighted about the ISO 13485 certification which confirms the compliance of standards and manufacturing process quality and innovation. Working with UL gave us a lot of insights into how regulatory compliance has to be a part of the product DNA itself, and not something that adds up at the end. The early-engagement program of UL greatly helped us understand what was involved in making our product ready, not just for India, but for various global markets as well', said Dr Shyam Vasudevarao, president & CTO Forus. Forus is a pioneer of frugal innovation in ophthalmology, and its product, 3nethra is the world's first inexpensive, portable, ophthalmic pre-screening device. By identifying five major eye ailments, 3nethra negates the deployment of multiple, expensive devices.   Forus has installed over 220 3nethras and is planning to exceed 400 installations in the next 6-9 months. The ISO 13485 certification, was received in seven months since the quality system effort was initiated. To maintain this certification, company personnel involved in the product lifecycle must be committed to readiness and compliance. Going forward, Forus will engage with UL for their upcoming certification and regulatory requirements for various global markets. On the Forus milestone, Mr Suresh Sugavanam, MD, UL India and South Asia said, "UL has extensive experience across all global markets, and a deep understanding of the complexities of various regulations. In the last few years, we have seen a huge appetite among Indian SMEs and start-ups for accessing global markets. In India, UL's key goal is to demystify global regulations through early engagement in product lifecycle and certify compliance thereto. In our engagement with Forus, we were witness to a high level of commitment and drive from the management to spearhead efforts towards regulatory compliance." ISO 13485, "Medical devices -- Quality management systems -- Requirements for regulatory purposes" is the globally recognized quality systems standard that helps organizations ensure the consistent manufacturing of their medical devices. An ISO13485 certification through an accredited third party registrar certifies an organization's compliance with the standard leading to enhanced credibility in regulated markets. ]]> https://biospectrumindia.com/interviews/97/5493/we-study-customer-preferences-while-developing-new-products-mr-sankaranarayanan.html https://biospectrumindia.com/interviews/97/5493/we-study-customer-preferences-while-developing-new-products-mr-sankaranarayanan.html Wed, 27 Nov 2013 18:01:00 +0530 After 10 successful years in India, Eppendorf India Ltd, is now exploring opportunities in the healthcare research sector. It is setting up a new state-of-the-art laboratory and service center in Chennai, which it believes will further strengthen its services and products. Mr Sankaranarayanan, CEO, Eppendorf India Ltd, outlines that the company's key strategy is to offer premium products with best of quality and features. Q: Eppendorf completes 10 years in India. What was the market scenario for Eppendorf back then and how is it looking now?Mr Sankaranarayanan: The lifesciences market has grown leaps and bounds in the last 10 years. There were few ups and downs due to economic situations, but overall the market has been growing very well. Q: How is Eppendorf geared up in handling economic instability?I would term it as "slow-down" rather than "instability". We are very optimistic about the Indian market and we hope that the market will be back to the earlier growth rates shortly. Such slowdowns are not very new and we are working closely with our customers and partners to improve our sales in the market. Q: What are some of your new focus areas?We are exploring more opportunities in the health research areas as the government is planning to invest in this segment. We are also increasing our marketing activities to reach new customers including exploring new applicational fields for our products such as bio-processing. Q: Elaborate on your major investments for 2014-15? We are building a new corporate office and warehouse in Chennai. The new facility will also have a state-of the-art laboratory and service center. We will further strengthen our technical service with more accreditation and innovative service products. Q: Have you signed up for new partnerships and collaborations nationally and internationally?As Eppendorf is launching several new products, we are currently focused on taking the new products effectively into the markets.   Q: Any acquisitions planned in the future?Eppendorf is very active in this area and our team in Hamburg (Germany) is looking into this. Q: What are your recent flagship products and innovations?How have they been received in the Indian market?We have entered the tissue and cell culture consumables and cell imaging consumables market with very innovative products. These products have been well accepted and we have received orders from several leading pharmaceutical and biotech companies in India. We have also launched plate readers, fluorescence spectrophotometers, and spectrophotometer with kinetics. These products have also been well received and we have got several orders, both from the government and private organizations. Micro centrifuge tubes (1.5/2.0 mL capacity) launched by Eppendorf 60 years back had created history. Now, Eppendorf rewrites the history by launching Eppendorf Tubes 5.0 mL. This product has been accepted instantly by customers worldwide and we have also got wonderful response in India. Q: What makes Eppendorf's products stand out from its competitors?While developing new products, Eppendorf spends lot of time in understanding the customer's preference and the current way of working with the products. We also carry out several beta tests before we launch products. Several Indian customers were our beta test customers and they have purchased the products immediately upon launch. All Eppendorf products are user friendly and ergonomic. Our physiocare concept is now applied to as many products as possible. Q: Who are your major competitors? What are your strategies in handling the strict competition?With the advent of Internet, now the competition profile is very similar across the globe. All major companies have direct presence in the country. Competition offers choice to our customers, and I feel this is a very important part of the market. Our strategy has always been offering premium products with best of quality and features. Q: Ten years is a long time. How do you intend to further retain your customers' trust, confidence, and satisfaction?We are constantly working on providing products and services which make the life of our customers easier. We will continue to offer state-of-the-art products and services. Our mobile pipette calibration service (PcoC) is one such product which offers pipette calibration at the doorstep.   Q: Who are your major clients in India?During the last 10 years, we have enjoyed a very good market reputation. Our products are required in every molecular biology lab. Due to the nature of our products, most of the leading biotech and lifesciences companies including research institutions are our customers. Q: What has it taken for Eppendorf in these 10 years to build profitability and successfully reign in the industry?Our dedicated sales and service team has been constantly working on providing our customers with all information and support. Our team is the reason for all the success that our products and services enjoy in the market. I expect similar support from all of them in the years to come. ]]> https://biospectrumindia.com/news/97/5312/carestreams-newest-image-acquisition-adds-support-for-dr-imaging-systems.html https://biospectrumindia.com/news/97/5312/carestreams-newest-image-acquisition-adds-support-for-dr-imaging-systems.html Mon, 18 Nov 2013 15:00:00 +0530 Carestream's newest version of Image Suite Software offers a flexible image acquisition, processing and storage platform that now supports CARESTREAM wireless DR as well as CR imaging systems. An optional mini-PACS. Image Suite offers web-based patient scheduling, image review and reporting, and flexible archiving solutions. Unveiled on the same week as The International Day of Radiology, this versatile offering is ideal for urgent care centers, imaging clinics and also for physicians and specialists, including orthopedists, podiatrists and chiropractors. The new software is available worldwide. "We offer a flexible platform for customers who want to move from CR to DR or from film to digital imaging. Our software offers the same user interface and work flow for both modalities, which reduces training time and makes the transition easier," said Heidi McIntish, Carestream's global marketing manager for X-ray Solutions. "Existing Image suite users can upgrade to DR technology with a minimal investment because they keep the same console and software platforms and just add a DR detector and license." The software now supports images captured by Carestream's wireless DR systems using the DRX-1 and new small format DRX 2530C (25 x 30 cm) detectors, as well as Carestream's tethered TDR 3543 detector and TDR 3543C detector that are available in selected markets. This is an addition to the current support of the DIRECTVIEW Classic CR and the DIRECTVIEW Vita family of Cr systems. The system also supports a wide variety of specialty measurement tools including Lippman-Cobb angle, geometry and coxometry. Other new Image Suite Software upgrades include:- Vendor-neutral exposure index value for each image so technologists can see if they are within the exposure range.- Hardware and software that can automatically acquire DAP and technique information from multiple vendors' generators and DAPs. This eliminates the need for manual data entry; and- Supports transfer of images to OrthoView software for pre-operative orthopedic planning and templating.   ]]> https://biospectrumindia.com/news/97/4827/quintiles-launches-data-driven-trial-execution-powered-by-infosario-clinical.html https://biospectrumindia.com/news/97/4827/quintiles-launches-data-driven-trial-execution-powered-by-infosario-clinical.html Thu, 14 Nov 2013 17:56:00 +0530 Quintiles has announced the launch of its comprehensive, fully-integrated Data-driven Trial Execution offering, which leverages the concept of risk-based monitoring to improve clinical trial delivery. While the industry's current approach to risk-based monitoring focuses solely on clinical trial monitoring, Data-driven Trial Execution combines study start-up, project management, clinical monitoring, data management and analytics to optimize trial conduct while meeting regulatory demands and quality requirements for Good Clinical Practice (GCP). "Our customers are seeking to manage clinical trials with greater efficiency, seamless execution and predictive insights that enable them to respond faster and make better-informed decisions," said Paula Brown Stafford, president of Clinical Development at Quintiles. "Data-driven Trial Execution is the first in a series of standardized offerings that Quintiles plans to bring to market, and is our answer to optimized trial execution that has the potential to improve quality while reducing overall trial costs by up to 25 percent." Quintiles is an industry leader in risk-based monitoring, having delivered more than 80 projects involving risk-based monitoring principles and processes across more than 20,000 sites and 200,000 subjects. Quintiles Data-driven Trial Execution builds upon that experience and represents a true shift in clinical trial oversight, introducing a central data surveillance team that performs ongoing reviews of data to monitor risk and facilitate the right action at the right time. Data-driven Trial Execution is powered by enhancements to the award-winning Quintiles Infosario® platform, adding advanced analytics that provide biopharmaceutical customers with a real-time view of a study's status and progression for enhanced transparency and collaboration across stakeholder groups. With the Infosario platform, Quintiles project teams can gather insights of critical data in a single, 360-degree view allowing for early identification of risks and potential issues with automated triggers and alerts that guide action plans. Project teams now have real-time visibility to critical information across programs, including projected study visits, to enhance study execution, improve predictability and maximize customer investments. ]]> https://biospectrumindia.com/news/97/4954/nccs-scholor-receives-bd-tcs-award-.html https://biospectrumindia.com/news/97/4954/nccs-scholor-receives-bd-tcs-award-.html Thu, 14 Nov 2013 16:48:11 +0530 BD Biosciences, India in collaboration with The Cytometry Society - India (TCS) instituted an award for "Excellence in Flow Cytometry" in 2009 to recognize the creative use of flow cytometry as a tool for addressing problems in the fields of clinical or basic research. The BD-TCS Award constitutes a prize of Rupees One Hundred Thousand and a citation. Eligible investigators submit their published papers, which are screened by a national committee constituted by the President, TCS and the shortlisted papers are evaluated by an international jury consisting of eminent flow cytometry experts. The winner is felicitated at the Annual Meeting of TCS. This year 5th BD-TCS Award Function was held at Bhubaneshwar, State of Odisha in India which also hosted the 1st BD-TCS Award function in 2009. The recipient of the 5th BD-TCS Award (2013) is Reecha Shah, a research scholar from the lab of Dr Padma Shastry at National Centre for Cell Sciences, Pune. She won the Award for her paper elucidating molecular mechanism of sodium valproate (VPA) potentiating the cytotoxic effects of anti-cancer drugs. The study provides new information on the possible utility of VPA, a commonly used anti-epileptic drug, in combination chemotherapy. On receiving the coveted BD-TCS Award, Reecha Shah said, "It is a great feeling to receive an award from such a prestigious platform. It is indeed very encouraging to see that our work is getting appreciated by the community and paves way for many more aspirants to participate each year. I hope this award takes me to greater heights as I plan to move to San Jose soon." YS Prabhakar - Business Director, BD Biosciences in India, said "BD Biosciences is proud of its association with TCS. We have teamed with TCS to reward meritorious scientific research in India. We believe this will go a long way in motivating life science research specifically by using Flow cytometry. Flow technology can be gainfully employed much more (than present level) for research or clinical purposes. We are confident that through interactions with progressive societies of scientists like TCS." Flow Cytometry has been recognized as one of the important technologies that transformed the face of modern life science and biotechnology research in India. Over the past few years, the technology has witnessed continuous improvement in multicolor analysis, high speed cell sorting, new fluorochromes, innovative reagent portfolios, and new emerging applications in health care research. Flow Cytometry makes the scanning of millions of cells in minimum time and cells of interest can be further tagged with suitable add-ons to study their various characteristics. Flow Cytometry is a count and measure of the physical and chemical characteristics of numerous biological particles such as cells, cell subsets, DNA, surface antigens and bacteria. ]]> https://biospectrumindia.com/news/97/5846/-agilent-inaugurates-crosslab-at-its-manesar-facility.html https://biospectrumindia.com/news/97/5846/-agilent-inaugurates-crosslab-at-its-manesar-facility.html Wed, 06 Nov 2013 11:29:00 +0530 The operating of CrossLab inaugrated on November 05, 2013 at Agilent's Manesar faility is expected to further strengthen the company's CrossLab Enterprise Services, a synchronized laboratory solution by Agilent Technologies, a service model for all instruments regardless of the brand. CrossLab will deliver solutions that help improve results, reduce costs, and increase the productivity across the organization. CrossLab Laboratory is an Investment done by Agilent Technologies to further strengthen the CrossLab Services initiative started in India 3 years back for providing comprehensive Service support to analytical instrument's from various manufacturers' which is used in Pharma, Biotech, Food , Environmental industries across India. This Laboratory will help increasing the capability of Agilent Service Engineering Team with hands on training on Analytical instruments from various manufacturers and there by developing Services protocol to provide comprehensive solution to their customers. Commenting on the inauguration of CrossLab Dr Siva Kumar Pasupathi, Country Head, Life Sciences and Chemical Analysis Unit, Agilent Technologies said "We are extremely proud of our CrossLab Laboratory which offers industry's best facilities to our customers. We understand and recognize that laboratories are often equipped with instruments from a range of vendors. Agilent CrossLab will enable simplification product selections and purchase for our customer. Apart from that, this initiative will also streamline their workday, and improve their overall productivity". Mr Luca Geretto EMEA & India Service Sales Manager, Agilent Technologies said "With Agilent CrossLab Services customers can reach the highest level of productivity. Customer can rely on one highly qualified engineer, who understands their work flow, goals to keep all instruments performing at maximum capacity." Dr Puran Lal Sahu, Associate Director AR &D, of a leading Pharmaceutical organization in India said "We have adopted Agilent Technologies CrossLab Since the last three years and we are extremely happy with the same. With CrossLab Services we can now focus on our job and the services of Analytical Instruments is looked after by Agilent Technologies. We are getting more options, best products and delivery through such a support." Traditional service models are more expensive, involve multiple points of contact with different vendors, and require in-house metrology teams to remain current on all the instrumentation. Agilent CrossLab Enterprise Services delivers solutions that help improve results, reduce costs, and raise productivity. Among services offered by Agilent CrossLab to its customers include worldwide technical and product selection assistance from experts; Ordering convenience by reducing the number of suppliers; prompt delivery through an unparallel global logistic network; high- quality supplies, backed by more than 40 years of chromatography experience and compatibility of non- Agilent instruments. Few core benefits of Agilent CrossLab --Comprehensive Support - From start to finish, Agilent CrossLab will take full ownership of client's instrument needs. --Maximum Instrument Uptime - Scheduled maintenance and qualifications, onsite inventory of parts, and an onsite engineer will make sure the systems stay up and running, and are serviced as quickly as possible. --Fast Response - The onsite engineer can address service issues immediately, minimizing instrument downtime and workflow disruptions.   --Extended Instrument Life - Agilent consistently delivers high-quality maintenance and repair services using genuine Agilent CrossLab parts, Agilent Certified Aftermarket parts, and OEM parts to help ensure long-lasting performance. --Cost Control - Agilent helps customer to avoid costly workflow disruptions by minimizing downtime, extending instrument life, and reducing your administrative burden so that lab personnel can focus on generating results. --Increased Productivity -Agilent works collaboratively with customers to deliver lab-wide strategies, engage in life-cycle and asset management, and utilize reporting tools to optimize your lab's productivity. --Streamlined Protocols - Reliable, whole-system service protocols and checklists ensure consistent, high-quality service. --Insightful Reports - Using analytical tools and industry know-how, Agilent offers a suite of data-driven reports to help you monitor lab performance, plan lab asset technology migration and manage asset life cycle.   --Consistent Levels of Service - Agilent protocols, scope of work, and checklists all ensure that customer will consistently receive the same high level of service on all your instruments. --Method Development/Validation Support - Agilent partners with customers to assist with method development and offers validation support to ensure the success of the next project. --Education and Training - Agilent offers extensive continuing education and training opportunities. With classes and courses that are provided online, at an Agilent site, or in your lab, we have a program to meet your needs ]]> https://biospectrumindia.com/news/97/7211/waters-introduces-acquity-qda-detector.html https://biospectrumindia.com/news/97/7211/waters-introduces-acquity-qda-detector.html Mon, 04 Nov 2013 14:44:00 +0530 On the same day, Mr Gary Harland, director, mass spectrometry product management, Waters Corporation, hosted a LIVE product webinar from the US for Indian journalists. In his presentation, Mr Harland said, "The QDa Detector essentially is a chromatographic detector, which delivers mass spectral information as a synergistic element of a chromatographic separation system. Designed, to be used as a detector for a chromatographic system, to be robust, reliable, and have no sample specific adjustments which will traditionally be associated with using mass spectrometry technology." Talking about the product features, Mr Harland expressed, "It has been designed to give chromatographers or analytical scientists much more information to completely characterize their sample without introducing the complexity of a mass spectrometer type product." He further added, "It has been designed to give the users information that can help make decisions, meet deadlines, improve productivity or the way laboratory processes are run." The company's press release also carried the following quote of Mr Art Caputo, president, Waters Division, which stated, "The ACQUITY QDa Detector is the realization of a vision that started 20 years ago at Waters. We foresaw a day when we could blend chromatography and mass spectrometry technologies together in a way that gives every analytical scientist access to mass spectral data regardless of their previous experience with mass spectrometry. The ACQUITY QDa Detector adds a whole new dimension to separation science and it is the most progressive leap forward in chromatography detection since the first photodiode detectors were introduced decades ago."   The ACQUITY QDa Detector is expected to transform laboratory processes like pharmaceutical discovery & development, chemical materials and food laboratories engaged in method development, sample profiling, synthetic chemistry and purification. In a series of questions imposed by BioSpectrum India during the webinar's Q&A session, Mr Harland responded with the following answers: Is the QDa available in India?Mr Gary Harland: Yes, it is. It is available already, and we have the instrument being shipped to our Indian customers. How is the QDa priced?For this product to be truly accessible, it should be affordable as well. Who are your clients for this product?Many of our early customers are collaborating with us. At this moment I can't disclose who has placed orders. Will there be an official launch of QDa in India?It is definitely available for sale in India as of today. But I need to confirm it with my colleagues at Waters India.   Can this product be used in the academia?Yes, we have seen a lot of interest from the academia. Whether it is for research or in chemistry departments, chemists need to test the samples. We've customers talking to us who are teaching undergradute courses to use it for academic purposes. How do you intend to handle the competition from products that compete with QDa?Good question. We have brought up something unique and new in today's market. There are many mass spectrometry products that are reasonable. Today, we have something which is certainly a big leap forward and we do not see a competitor for this product in the marketplace. Soon, our competitors will work faster and try to understand what we have done. How long did it take to design the QDa Detector?It took us about 2.5 years for us to understand the underlying technology and a lot of work has gone into it. Is this completely a Waters' innovation product?Yes, this is a Waters innovation. ]]> https://biospectrumindia.com/news/97/5741/scigenics-offers-affordable-indigenous-shakers-.html https://biospectrumindia.com/news/97/5741/scigenics-offers-affordable-indigenous-shakers-.html Wed, 30 Oct 2013 17:27:20 +0530 Recently the Chennai based company, Scigenics Biotech was in New Delhi to promote their indigenous range of multi-deck shakers, developed with the help from department of biotechnology (DBT) through the Small Business Innovation Research Initiative (SBIRI) scheme. In an impressive yet simple inaugural function, the company celebrated the occasion to mark the delivery of the ORBITEK - MDS to the Department of Biochemical Engineering and Biotechnology (DoBB) at Indian Institute of Technology (IIT), Delhi on October 01, 2013. Apart from the management of the company, present on the occasion were Dr Kalaivani Ganesan, scientist, DBT and Prof A K Srivastava, DoBB, IIT, who has been a long time user of the Scigenics products. The price of the instrument varies with the specific demands of the clients and these are customized according to the requirements in the laboratory. However, as per the company's management the price which is closer to Rs 20 lakhs is still much cost effective than the options offered by the competition. So far, the response has been remarkable and the company has received many orders already.The company is excited about the development and is looking forward to the success of this indigenous venture manufactured at its facility in Chennai. According to Mr S.Gopal, managing director, Scigenics Biotech, "Our objective is to manufacture innovative and reliable products keeping in mind cost effectiveness. The flexibility brought into our products greatly helps our scientists to work on a range of experiments". Among the few key features of the ORBITEK multi deck shaker are that it comes with easily removable movement assembly to maximize inner utility space for large capacity containers. Slide out universal pull-out platform with safety lock enables, ease to accessing culture flasks. There is also four-tier orbital shaker with temperature control (10 degree to 80 degree celsius) and isolated temperature control mode reduces the risk of contamination inside the chamber. Expressing her views on SBIRI funding, Ms S.Neela, executive director, Scigenics Biotech, "The singular benefit of SBIRI has been to empower us to think "We can". The SBIRI constantly mentored us to realize our true potential. The fact that SBIRI was trusting us, itself unshackled us from myopic views of an SSI and opened our vision and there was simply no looking back." Sharing his experiences, Prof A K Srivastava, mentioned, "There is no doubt that this shaker has added value to our research efforts. I have been always impressed with the way Scigenics promptly customizes the instruments as per our requirements. The flexibility offered by it has to be appreciated." Having launched the first ORBITEK brand of shakers through way back in 1997, Scigenics has improved both its products over the period of time. In the year 1999, the company launched the shakers as a multiple range.Then in 2002, it added incubators and hybridization chambers and by 2004, it achived the remarkable figure of having manufactured 1000th shaker. Marking competing international standards, the company in 2008, went on to launch the table top refrigerated shakers. Now, in 2013, Scigenics has crossed the selling mark of 3000 for the shakers. Apart from the shakers, Scigenics has been dealing in Plant growth chambers and CO2 incubators in technical collaboration with Astec Japan. ]]> https://biospectrumindia.com/news/97/7735/merck-millipore-india-hosts-web-of-process-regulatory-trends-2013-in-bangalore.html https://biospectrumindia.com/news/97/7735/merck-millipore-india-hosts-web-of-process-regulatory-trends-2013-in-bangalore.html Wed, 30 Oct 2013 11:37:00 +0530 Experts from Drug Control Department from government of India, pharmaceutical and biopharmaceutical industry came together to discuss and deliberate on various current key areas of focus in the industry. The topic discussion ranged from challenges and developments in aseptic processing, manufacture of biosimilars, to current regulatory and manufacturing trends and advancements in vaccine manufacturing technologies. The event witnessed about thirty speakers and panelists from India and abroad, along with senior officials from the regulatory agencies. Dr B R Jagashetty, Drugs Controller of Karnataka and guest of honor for the event, in his address said that Drug Control Department of Karnataka (DCDK) has taken a step ahead in investing and upgrading the drug control testing labs in order to make them equivalent to, or better than, any private testing labs. Lectures were also delivered by fourteen eminent professionals and subject matter experts (SMEs) from India and abroad on topics related to current trends, processes and regulations for the pharmaceutical and biotech Industry.   Mr H S Dayananda, head, Biopharm Process Solutions, Merck Millipore India, said, "The Web of Process & Regulatory Trends conference has continually gained the respect of the Indian regulatory as well as the industry, since its inception in 2002. It is regarded as a forum that promotes professional excellence, training and interaction between shop-floor and operating personnel, middle management, CEOs, pharmacists and regulators from within and outside India." He further said, "Merck Millipore aspires to offer similarly unique opportunities that benefit the pharmaceutical and biopharmaceutical industry in the years to come." Participants from over 140 senior and middle management professionals from various departments such as quality assurance, quality control, validation, manufacturing, regulatory, formulation R&D, projects and tech transfer graced the event with their presence. These professionals hailed from reputed companies including Biocon, Lupin, Intas, Dr Reddy's, Gland Pharma, Strides, Mylan, Cipla, Serum Institute, Kemwell and Hindustan Lever Limited. The panel discussions were chaired by leaders from the industry who shared their knowledge and experience with the participants. In conjunction with the latest trends and expectations of the industry, sessions related to flexible manufacturing and E&L generated lot of interest and lengthy interactions between the audience and the panelists. One of the guest lecturers, Dr Purvish Parikh, an international clinical researcher and recipient of National Citizen Award from Government of India spoke about establishing clinical comparability of Biosimilars. He impressed upon the audience the need for affordable medicines and hence, Biosimilars being the path ahead Another guest lecturer, Dr John Purves, a lifescience consultant, ex-EMA and ex-EHRA regulator, highlighted the legislative basis on which Biosimilar medicinal products in Europe were founded, and indicated the direction for future strategies. ]]> https://biospectrumindia.com/news/97/5870/icmr-to-hold-three-day-workshop-on-spss-use-for-data-analysis.html https://biospectrumindia.com/news/97/5870/icmr-to-hold-three-day-workshop-on-spss-use-for-data-analysis.html Tue, 29 Oct 2013 18:01:00 +0530 The National Institute of Epidemiology (NIE) located at Ayapakkam, Chennai is one of the permanent institutes of the Indian Council of Medical Research (ICMR). The institute has vast experience in teaching and training of medical doctors,  scientists and research investigators in the appropriate use and application of statistical methods. The three workshop  to be organized at the department of biostatistics in December, 2013, is designed for those who intend to use SPSS for their data analysis. The objective is to promote better understanding of logical handling of statistical data, properly representing the data using simple diagrams, methods to produce basic tables and data analysis using SPSS. The medical doctors, scientists, researchers and/or investigators of research projects, M.Phil/PhD program or a researcher from the field of social science / management / medicine, project member of an NGO, public health officials, and employees from industries who need to conduct quantitative data analysis as part of their work are eligible to apply. The programme will consist of class-room teaching and practical hands-on experience. Introduction, Type of input formats, variable types of data, labeling, defining categorical - ordered and dummy variables, transformation, computation, manipulation of records, managing multiple response, importing and exporting data files, exporting outputs, frequencies, descriptive, cross tables, simple diagrams and basic procedure for statistical data analysis. Simple statistical tests using parametric and non parametric methods. Syntax files and manipulation of syntax files and use of help menu will be given of special emphasis. Faculty will consist of experienced and dedicated staff members of this Institute. The Course will be limited to a maximum of 25 participants. The enrolment will be on the basis of first-come first-serve basis. ]]> https://biospectrumindia.com/news/97/4306/supreme-court-satisfied-with-new-clinical-trials-approval-process.html https://biospectrumindia.com/news/97/4306/supreme-court-satisfied-with-new-clinical-trials-approval-process.html Tue, 22 Oct 2013 17:49:00 +0530 The supreme court has expressed satisfaction with the process of approvals that were set in place for the trials approved since January 2013 and has asked that all trials approved before December, 2012 to have similar clearances to ensure the safety of patients in a clinical trial and minimize serious adverse events. The court was hearing the PIL filed earlier by NGO on October 21, 2013. "We appreciate that the Honourable Court considered the 162 cases for which approval has been given by the DCG(I) since the New Drug Advisory Committees were formed in 2011", said the spokesperson of ISCR while reacting to the remarks. "This is an encouraging development and we are glad that the Court and the regulatory bodies are taking measures to ensure the implementation of a robust regulatory framework. As a professional organization representing clinical research professionals across the stakeholder spectrum, ISCR is fully supportive of the need for a more transparent and regulated environment for the conduct of clinical trials in India which ensures the practice of the highest standards of ethics and quality and where patient rights and safety are protected." Spokesperson also refered to previous ISCR note dated October 4, 2013 where it was mentioned that the value and role of clinical research in ensuring better and more effective treatment for several thousands of patients in India is often overlooked. "It is only through clinical research that we have found and will be able to find newer and better medicines to treat our population and reduce mortality rates for various diseases, including those unique to our part of the world," stated the ISCR's latest note. The government of India sponsored Working Group on Disease Burden for the 12th Five Year Plan refers to the "triple burden of disease" that developing countries like ours are facing arising from communicable diseases, emerging non-communicable diseases related to lifestyles and emerging infectious diseases. In the larger context of India's unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs. India has 16% of the world's population and 20% of the global disease burden and yet, less than 2% of global trials take place in India. If we have to find better and more cost effective cures for these diseases in a population that is multi-racial and heterogeneous, it is necessary to conduct clinical research in India. The Indian Society for Clinical Research (ISCR) is an association of clinical research professionals that aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics. ]]> https://biospectrumindia.com/news/97/6082/sartorius-stedim-biotech-and-bd-diagnostics-strengthen-cooperation-in-microbiological-diagnostics.html https://biospectrumindia.com/news/97/6082/sartorius-stedim-biotech-and-bd-diagnostics-strengthen-cooperation-in-microbiological-diagnostics.html Tue, 22 Oct 2013 11:03:47 +0530 International pharmaceutical company Sartorius Stedim Biotech and BD Diagnostics, a segment of Becton, Dickinson and Company (BD), a global medical technology company, recently announced their collaboration to develop, manufacture and market various ready-to-use, pre-filled media products for microbiological applications in pharmaceutical, biotech and research laboratories. Mr Dominique Baly, member, Sartorius Group executive committee, said, "Through our agreement with BD, we have created an excellent collaboration. BD is known worldwide for its expertise in manufacturing and filling of microbial media. BD's expertise combined with Sartorius Stedim Biotech's know-how in polymeric technologies and applications will help us further extend our expert capabilities in the field of microbiological monitoring." Sartorius expertise in the development of membranes offers high-quality, single-use filter products for concentration of microbial contaminants in the lab. As part of this strategic collaboration, BD will fill special Sartorius single-use products with BD culture media and supply these to Sartorius as prepackaged products. In addition, both the companies are said to be exploring options of extending their existing business relationship by pursuing further innovative solutions in the field of microbiological diagnostics. "The products we plan to develop under our agreement with Sartorius Stedim Biotech will enhance laboratory efficiencies for our pharmaceutical, biotech and research customers with these unique product offerings," said Mr Bob Ferguson, VP & GM, BD Diagnostics - Diagnostic Systems, Industrial Microbiology. Mr Ferguson further added, "By combining Sartorius Stedim Biotech's bioprocessing and filtration expertise with BD's microbiological media capabilities, customers will benefit from improved lab productivity and standardization of sample processing." ]]> https://biospectrumindia.com/news/97/6526/healthcare-it-vc-funding-witnesses-surge-.html https://biospectrumindia.com/news/97/6526/healthcare-it-vc-funding-witnesses-surge-.html Thu, 17 Oct 2013 14:16:00 +0530 Mercom Capital Group, llc, a global communications and consulting firm, recently released its report on funding and mergers and acquisitions (M&A) activity in the Healthcare Information Technology (IT) sector for the third quarter of 2013. According to the report, venture capital (VC) funding in the sector continued to rise in yet another record quarter with $737 million raised in 151 deals. The dollar amount of disclosed deals surpassed the second quarter total of $623 million. Year to date, the Healthcare IT sector has raised a disclosed $1.85 billion. While the 2009 HITECH Act helped launch the sector through its $17 billion allocation towards the adoption of meaningful use of healthcare IT, private investments into the sector have continued to rise with increasing EHR adoption. Release of healthcare data by the U.S. Department of Health and Human Services has also contributed to the growth of healthcare products and applications focused on consumers. "Funding into Healthcare IT is on pace to double over last year," said Raj Prabhu, CEO of Mercom Capital Group. "With major parts of the Affordable Care Act on the horizon, the focus is on health insurance exchanges, preventative care, wellness, population health, and a general shift from quantity to quality of care, which is reflected in this quarter's funding transactions." Healthcare practice-focused technology companies received $489 million in 59 deals with population health, EHR/EMR, practice management, and data analytics companies all receiving attention this quarter.   Consumer-focused companies received $248 million in 92 deals, with most funding ($161 million) going to the mobile health category, with mobile health apps and sensors receiving the most funding this quarter. The top VC funding deal in Q3 2013 went to Evolent Health, a population health management organization that integrates technology, tools and services to support value-based care and payment models, which raised $100 million from The Advisory Board Company, UPMC Health Plan and TPG Growth. Other top deals in the quarter included Practice Fusion, a free web-based EMR provider, which raised $70 million from Kleiner Perkins Caufield & Byers, OrbiMed Advisors, Deerfield Management Company, Industry Ventures, Artis Ventures, Morgenthaler Ventures, Felicis Ventures, Glynn Capital Management, Band of Angels Acorn Fund, H Barton Co-Invest Fund, and Goldcrest Investments; MedSynergies, a provider of revenue and performance management solutions for healthcare providers, raised $65 million from undisclosed investors; Fitbit, a fitness and health tracker company, raised $43 million in private equity financing from Qualcomm Ventures, SAP Ventures, SoftBank Capital, Foundry Group and True Ventures; and Oscar, a technology-based health insurance and telemedicine provider, raised $40 million from Thrive, Founders Fund, General Catalyst, and Khosla Ventures. There were a total of 168 investors in Q3 2013, including VCs, accelerators, incubators and crowdfunding platforms, compared to 161 investors in Q2 2013. Six investors participated in multiple funding rounds compared to 11 in Q2 2013. Kleiner Perkins Caufield & Byers and The Social+Capital Partnership were the most active investors and participated in four deals each. The remaining top investors participated in three deals apiece. They included FirstMark Capital, Founders Fund, HLM Venture Partners and Khosla Ventures. Acquisitions (M&A) in Healthcare IT totaled $1.1 billion in 45 transactions. Last quarter saw $108 million in 30 transactions. The most active categories for M&A transactions included Revenue Cycle Management with nine, followed by Practice Management with eight, and Telehealth with four transactions. There were only six disclosed M&A transactions in the third quarter, including the $644 million merger of Greenway Medical Technologies, a provider of an EHR, practice management and interoperability solution platform, and Vitera Healthcare Solutions, an EHR and practice management software provider; the $200 million acquisition of Medical Management Professionals, a medical billing and practice management company (subsidiary CBIZ), by Zotec Partners; and the $200 million acquisition of Cardiocom, a developer and provider of integrated telehealth and remote patient-monitoring services, by Medtronic. The Advisory Board Company acquired Medical Referral Source, a web-based software program that streamlines patient referrals from primary-care doctors to specialists, for $11.5 million; and IMS Health acquired Diversinet, a provider of secure, patented mobile technologies and connected health solutions for healthcare organizations and partners, for $3.5 million. Also in Q3, Mastech Holdings' Healthcare Unit was acquired by Accountable Healthcare Staffing for $1.15 million. ]]> https://biospectrumindia.com/features/97/8478/dialysis-centers-should-focus-on-cost-efficiency-without-compromising-quality.html https://biospectrumindia.com/features/97/8478/dialysis-centers-should-focus-on-cost-efficiency-without-compromising-quality.html Tue, 15 Oct 2013 16:46:00 +0530 Seven and half years ago, when Mr Vikram Vuppula's uncle passed away because of chronic renal failure, he was utterly shocked to see the conditions prevailing in hospitals providing dialysis care. He felt that dialysis care units in India needed a massive improvization through redefining the existing system. It was then he realized that professional dialysis services was absolutely needed in the country. With more than 10 years experience in the US healthcare industry, Mr Vikram Vuppula, along with Mr Sandeep Gudibanda, and Mr Kamal Shah, founded the now four-year-old company, NephroPlus, a chain of kidney care clinics across India. They started their first unit in Hyderabad in February 2010, with an investment of 1 crore rupees. Having received a good response, six months later they started their second unit in Hyderabad, followed by the third one in Mahabubnagar, about 100 kilometers away from Hyderabad. Adds Mr Vikram Vuppula, founder & CEO, NephroPlus, "Today, renal care in India is in a bad shape. Dialysis centers run by hospitals do not tend to operate with real focus, since hospitals are more profit oriented. Hospitals know that dialysis care does not return much on investments. It is merely run by technicians."   On similar lines, Mr Sandeep Gudibanda, co-founder & director of business development, NephroPlus, feels that dialysis care in India is conducted in a disorganized way at dialysis centers, as opposed to in US, Australia and European countries. Currently there are about 2 lakh dialysis patients in India. Out of which, only 70,000 of them have easy access to dialysis care. Most patients die because of inaccessibility of renal care in remote villages, or due to unaffordability factor involved in the treatment process. Mr Kamal Shah, co-founder & director of patient services, NephroPlus, who is on dialysis since 1997, believes that the quality of dialysis centers in the country today do not adhere to basic hygiene. He said, "At NephroPlus, we address both quality aspects and hygiene. Cross-infections are rampant in dialysis centers. Our USP is we steer clear of any possible cross-infections. Patients who are on dialysis end up contracting liver diseases because of cross-infections by Hepatitis C & B or even HIV, as a result of poor techniques followed by doctors and nurses. We manage to address this issue and identify possible dangers by introducing good processes and methods in our centers, where cross-infections are totally eliminated." The country today has severe shortage of Nephrologists and trained technical staffs. "The government can help pay for some of the academic trainings involved in training qualified technicians. The awareness among the students is also lacking. The government, again, should help create awareness in funding and training fresh graduates. We at NephroPlus are willing to provide the training, but it has to be structured and funded by the government," expressed Mr Vikram. Under chronic kidney failure, patients are either expected to get a transplant or be on dialysis for the rest of their lives. Dialysis at times can be a frustrating experience. At NephroPlus, the treatment is said to be more patient-centered. Says Mr Sandeep, "You need to be on dialysis for four hours, for at least three or more times a week. During those hours, for entertainment we offer individual television sets along with a satellite dish connection and headphones to patients. We also provide a wi-fi connection to our patients so that they can surf the internet. Patients can come to our centre, either after or before going to work. After dialysis, if the patient feels dizzy or is unable to drive, we provide them with drop facility, including picking them up prior to dialysis, if needed." Mr Vikram opines that hospitals realize that there is not much return for their investments and hence do not offer dialysis service. "We need a place where patients can avail quality dialysis services. Today, patients travel all over the country to get dialysis. The government should actually get involved in the forefront to ensure that dialysis is made available for the poor as well. We are working on a public-private partnership project in Hyderabad with the help of government hospitals, making dialysis affordable for people who can't afford regular checkups." Today, dialysis centers should focus on cost efficiency without compromising on quality. Bringing in the best models and making it more affordable to patients will enhance renal care in India. "In the US dialysis costs about $250 per session. However, it is a mere $25-30 in India. We use the same machines and consumables as the west. However, currently India can't afford more advanced machines," said Mr Vikram. NephroPlus looks forward to have hundred centers in the next three years, making dialysis affordable throughout India. The company has been funded by venture capital firm, Bessemer Venture, in 2011.   ]]> https://biospectrumindia.com/news/97/4625/phenomenexs-new-core-shell-hplc-prep-column-to-enable-higher-loads-for-pharma-lab-purification.html https://biospectrumindia.com/news/97/4625/phenomenexs-new-core-shell-hplc-prep-column-to-enable-higher-loads-for-pharma-lab-purification.html Fri, 11 Oct 2013 15:16:00 +0530 The new 30 mm column will enable increased loading of sample and throughput. With the addition of this larger diameter column, Phenomenex offers core-shell media line can be used from analytical scale through scale-up to purification. The Phenomenex Axia preparative format is said to deliver longer column lifetime, higher efficiencies, improved performance and high reproducibility, compared to conventionally packed columns for lab-scale preparative chromatography. "Our range of Kinetex core-shell particle size offerings, including 1.3-, 1.7-, 2.6- and 5-micron, enables exacting scale-up in pharmaceutical applications, eliminating extensive method rework," said Mr J T Presley, brand manager, Phenomenex. "The 30 mm columns are now available in C18, XB-C18, C8 and Phenyl-Hexyl phases, and we will be introducing more phases in the near future," he added. 5-micron is claimed to be the largest particle in the Kinetex core-shell family, delivering better performance than 5-micron fully porous offerings, with no increase in backpressure.   In fact, the 5-micron media provides 60 to 90 percent higher average efficiencies compared to the same size, fully porous columns with little to no method development. Phenomenex's patented Axia packing and hardware technology, which was introduced in 2005, eliminates the drawbacks of traditional slurry packing, delivering uniform bed density and dramatic performance advances. Kinetex core-shell technology in the Axia preparative format is seen to perform well which is advantageous to users in pharmaceutical and natural products development, who can use scalable core-shell solutions from analytical stage UHPLC or HPLC methods to purification. ]]> https://biospectrumindia.com/news/97/6662/ge-india-tech-mela-2013-a-family-day-with-a-technology-twist.html https://biospectrumindia.com/news/97/6662/ge-india-tech-mela-2013-a-family-day-with-a-technology-twist.html Tue, 08 Oct 2013 11:05:00 +0530 On October 5, 2013, GE India Technology Centre organized their annual 'Tech Mela 2013' at KTPO, Whitefield, in Bangalore. The mela showcased GE's technological innovations and products in the area of healthcare, transportation engineering, energy management, electrification & automation, oil & gas, appliances and aviation. Speaking to BioSpectrum, Mr Shyam Rajan, chief technology officer, GE Healthcare India, said, "Most of our innovations are technologically centered. This mela is a great way to bring our innovations together and showcase them. Not only that, we also get to see what the other sectors in GE are up to as well. This event is thrown open for families too, so our employees' families have a chance to get a glimpse of what their family member is working on at GE. Employees are really proud to see their work and showcase them to their families. In other words, it is a family day with a technology twist!" Talking about the objective behind organizing this technology mela and how technology can make a huge difference in the lives of millions, Mr Manoj Menon, communications leader, Wipro GE Healthcare, expressed, "We make a host of technological products which touches many lives. We design products around patients and users. People really don't know what goes behind the real technology. We need to make people more aware and knowledgeable, so that they can associate with what we have to offer. Hence, we try to give an experience and create awareness among the people. We are also using social media extensively to accomplish this." Mr Menon further added that healthcare is all about creating value and design, and humanizing it. "If we can create a series of solutions, more and more doctors and hospitals will be able to offer those solutions, and consequently, more people will be able to access those solutions. So our theme revolves around creating value and experience, which is favorable to all," he said. Commenting on GE Healthcare's walk-through theme at the mela, Mr Rajan added, "We are at work for a healthier India. This time, we've adopted our healthcare theme as 'Tunnel of Life', where we showcase our innovations which are used in the life cycle of human beings, from the fetal stage to all the way through to the adult life, ranging from maternal & fetal care, ultrasound, baby care, X-ray technology, Magnetic Resonance Imaging (MRI) and other equipments." Mr Rajan also emphasized that GE Healthcare is currently focusing on three major areas: mother and infant care, cardiology and oncology.   Ms Garima Varma, communications leader, GE Global Research, John F Welch Technology Centre, told BioSpectrum, "It is a technology showcase that we do in order for our employees to take pride in the kind of work they are involved in. It is an opportunity for the businesses' to showcase what they are doing, and it is our engineers' work at its best. It is our endeavor to celebrate technology. We want to bring in the festive mood and explain technology in a simple way to everyone, whether it is a 90-year-old or a 9-year-old." Employees with their families were spotted having a great time over the weekend. Special activities and games were organized for all children who were at the venue. Playback singing and dance performances by employees added an extravagant color to the mela. ]]> https://biospectrumindia.com/news/97/5584/iscr-requests-media-to-report-objectively-on-clinical-trials-.html https://biospectrumindia.com/news/97/5584/iscr-requests-media-to-report-objectively-on-clinical-trials-.html Mon, 07 Oct 2013 17:51:00 +0530 With reference to recent media reports that appeared following the PIL Hearing on Clinical Trials - Writ Petition (Civil) No(S). 33 Of 2012 - that was held on September 30, 2013, Indian Society for Clinical Research has sought to draw attention of national media to the Supreme Court Order released on Oct 03, 2013. "In the interest of ensuring accuracy and a factual representation of Court Orders and to protect the interest of patients participating in clinical trials, it is our urgent and ardent request that while reporting the Supreme Court Hearings in regard to Writ Petition (Civil) No(S). 33 of 2012, to wait until the Supreme Court Order is passed rather than base reportage on Court proceedings that may not be reflective of the final Court Order," read the email message from chairperson, ISCR Media Council. The statement issued by the association further stated that while it believed that the media can play an important role in educating the larger public about clinical research, besides highlighting the rights and responsibilities of patients. "It is only through clinical research that better and more effective treatments can be discovered for lifestyle illnesses and illnesses that are endemic to our country," it stated. "We appreciate that the Court Order took note of the observation of the health ministry that "clinical trials are necessary for the development of new drugs in the country. India has the capacity and knowhow for drug discovery research. However, there should be a robust system for conducting clinical trials in the country to ensure that trials are conducted in a scientific and ethical manner and in compliance to the regulatory provisions." Urging media to ensure restraint while reporting on the supreme court orders related to clinical trials, the statement mentioned further, "It is an ardent request to the media that while reporting the Supreme Court Hearings in regard to Writ Petition (Civil) No(S). 33 Of 2012, to wait until the Supreme Court Order is passed rather than base reportage on Court proceedings that may not be reflective of the final Court Order. This is particularly true of an industry where misrepresentation of information could be a matter of life or death for patients for many of whom participation in clinical research is the only hope of cure or treatment. For many patients, time is a currency they do not have and for their sake we cannot afford to derail the clinical research process that is ongoing in our country." ]]> https://biospectrumindia.com/news/97/7909/healthcare-accessibility-and-affordability-a-major-challenge-in-rural-areas-mr-srikanth-muthya.html https://biospectrumindia.com/news/97/7909/healthcare-accessibility-and-affordability-a-major-challenge-in-rural-areas-mr-srikanth-muthya.html Tue, 01 Oct 2013 16:47:00 +0530 With an outlook to set up R&D centers in India, he is confident that the healthcare sector will always be an evergreen area for business and investments. He says that only through building healthcare awareness among people through constant support from the government and organizations, the message will be driven home. Here are the excerpts from the interview: What are your major challenges in the area of healthcare innovations?Mr Srikanth Muthya: We genuinely need to build more awareness on diagnostics. When it comes to patients and customers, early detection of diseases is very important. For the urbanites, it is not a big challenge to get a simple ECG done. But the real challenge is in the rural masses in terms of accessibility and affordability, which we continue to struggle in India. The government should wake up at a time like this, and we'll be able to do a lot more. We need to bring in more awareness and productive diagnosis procedures to people. If that happens, things will automatically fall in their place. What are your expansion plans and strategies in India?We are looking at partnering with the government to drive public-private partnerships. We want to reach out to masses because healthcare accessibility remains a big question. We want to bring in various good financial models for our customers who can afford and access basic healthcare. We are also focusing on driving affordability. We also would like to begin our R&D centers where our products will be completely designed and manufactured in India. What strategies do you employ amidst economic instability?Our business still continues to grow. We do not see any impact on our business as a result of economic instability. There will be short term churns in the forex, but people will always need healthcare. We are here to stay for a long time. Healthcare is an evergreen segment. We look at our business in the light of next four or five years and then operate in those spaces. Where are your current healthcare investments for 2013?We are right now focusing on five important key areas: Cardiology, Critical Care, Emergency Care, ICUs and Operation Theater Care.   What are your new innovations that you are working on?We recently launched ourselves in to mother and child care. We have made significant progress. We will constantly endure to continue to focus on mother and child care business. Moreover, the line between software and hardware is getting thinner and thinner and it is getting diminished. We'd like to work on connecting various devices as in receiving alerts on cell phones, smart algorithms managing ICUs, and machines in operating theater communicating with people. Here, information is going to be the key. Tell us something about staff development and trainings at Philips?Talent and organizational development is one of the key areas for anyone joining our management. We focus a lot on training people, unless they are trained and professionally certified. Our key responsibility areas also include building peoples' goals and objectives. We also strongly believe in mentorship. Our people will always have someone called 'guru', to whom they can refer to. It helps the employees to keep motivated and being transparent to customers. In the process, we also try to build a family together. What advice would you give foreign companies who want to invest and expand in India?Foreign companies should first get a foothold on the customers' needs in India. They mandatorily need to know about RoI, price sensitivity, value added services, clinical efficacy and the outcomes and expectations of patients and customers. More importantly, they need to understand the Indian market or partner with someone who understands that. Hence, it is crucial to understand the local space. How is the market looking for Philips healthcare products?It is booming and will continue to boom because of emerging new diseases, and increasing affordability and accessibility factors. We are now taking our services to the rural areas. I believe that there are three industries that will always remain evergreen: Food, textiles and healthcare. If I had to invest my money, I'd invest in these three areas. Are you focusing on any new markets?One of the strategies we have is that we are getting in to solutions space. We want to actively solve customers problems and make it easy for them. We have a strong service, along with strong projects and people, involving engineers and salespersons, all of whom are headed by our great leader. We are in to meeting end-to-end solutions.   ]]> https://biospectrumindia.com/news/97/3443/philips-demonstrates-aed-usage-at-its-campus.html https://biospectrumindia.com/news/97/3443/philips-demonstrates-aed-usage-at-its-campus.html Wed, 25 Sep 2013 10:42:00 +0530 AED is a portable electronic device which provides defibrillation, that is, it applies electrical shocks which stops the irregular heartbeat, thus allowing the heart to reestablish a normal effective rhythm to a person who has suffered a cardiac arrest. The demonstration was delivered by chief guest, Dr Mabel Vasnaik, consultant & head, Adult Emergency Department, Manipal Hospitals. She added, "Ten years ago we had older people in their 60s and 70s having cardiac arrest. Today, youth even as young as 22 or 25 years end up having this killer ailment." She attributed this scenario to peoples' poor life style including lack of exercise, obesity, high blood pressure, stress and smoking. She further added, "People suffering from diabetes are also prone to sudden cardiac arrests as they tend to suffer from heart diseases which ultimately end up in heart attack." Mr Srikanth Muthya, director, patient care and clinical informatics, Philips, said, "We strongly believe that the only way to deal with cardiac arrest is to build awareness and educate people by emphasizing its significance in the Indian context. We are lobbying with the government to make AEDs mandatory, which is the case in US, UK and European countries" AED has many advantages over the traditional defibrillators. "It is light, portable and can be part of the first-aid kit, which can be easily transported anywhere," said Dr Mabel Vasnaik. Talking about Philips' collaboration with the government about creating this awareness, Mr Srikanth added, "We have made a representation to the government about the importance of AEDs. The government has to consider having AEDs in public places and in various public automobiles. Thus, ultimately the message will be driven to the people." ]]> https://biospectrumindia.com/news/97/6005/eppendorfs-revamped-vacuum-concentrator.html https://biospectrumindia.com/news/97/6005/eppendorfs-revamped-vacuum-concentrator.html Mon, 23 Sep 2013 12:23:00 +0530 The new lid is said to increase the scope of the instrument for several biological applications in various industries. The Concentrator plus with advanced heating technology will provide treatment for samples assuring quick, efficient and gentle vacuum concentration of DNA/RNA, nucleotides, proteins and other liquid or wet samples. With three different application modes to correspond to various solvent types - aqueous, alcoholic or high vapor pressure, processing time for sample evaporation will now reduce by 20% said Eppendorf's press release. Eppendorf is a life science company that develops and sells instruments, consumables, and services for liquid, sample, and cell handling in laboratories. ]]> https://biospectrumindia.com/news/97/6144/cell-analyzer-from-bd-enables-complex-multicolor-experiments.html https://biospectrumindia.com/news/97/6144/cell-analyzer-from-bd-enables-complex-multicolor-experiments.html Tue, 17 Sep 2013 16:16:23 +0530 BD Biosciences, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, has recently launched the BD LSRFortessaTMX-20 Cell Analyzer, the latest in its line of high-performance research flow cytometers. The BD LSRFortessa X-20 Cell Analyzer delivers high-performance multicolor analysis with the most compact footprint in its class at just 30" x 29" (76.2 X 73.7 cm) and a height of 30" (76.2 cm). Recognizing that space is a valuable commodity in today's research environment, BD Biosciences designed the BD LSRFortessa X-20 Cell Analyzer to be compact without compromising the power needed. Offering a new level of flexibility, the analyzer can be configured with up to five lasers to detect up to 20 parameters simultaneously. While popular laser choices include blue, red, violet, yellow-green and UV, a wide range of up to 34 available laser choices are available as excitation sources. Each excitation source is supported by new polygon detector arrays, and each polygon can support up to eight detectors for maximum flexibility in optical configuration. The BD LSRFortessa X-20 Cell Analyzer is designed by BD's special order program that enables customers to configure BD flow cytometers and cell sorters to fit precise research and assay needs. This program is tailored to meet the needs of researchers at the leading edge of biomedical discovery. The platform is also supported by a full range of BD Biosciences reagents. "The new BD LSRFortessa X-20 Cell Analyzer will enable researchers to conduct complex experiments with the additional parameters and increased sensitivity they need," said Alberto Mas, President, BD Biosciences. "Uncovering dim staining and rare cell populations is extremely valuable to complex multicolor assays, which are tools for advanced disease or drug development research." ]]> https://biospectrumindia.com/interviews/97/5577/phenomenex-india-looks-forward-to-strong-customer-service.html https://biospectrumindia.com/interviews/97/5577/phenomenex-india-looks-forward-to-strong-customer-service.html Wed, 11 Sep 2013 17:31:00 +0530 In its third year of business in India, Phenomenex India is continuing to expand on its original position for moving directly into the Indian market, namely unparalleled customer service and support. To that end, Phenomenex has strived to hire the astute and technically trained application specialists in the industry. In an interview to Raj Gunashekar, Nicholas (Nick) Mitchell, Managing Director, Phenomenex India Private Ltd, Hyderabad, outlines the plans of the company and market opportunities. What are the current market trends for separation science industries in India? The current market trends in India's separation science market are incredibly competitive. With the recent significant decline in the rupee (and a two year trend of the same since 2011), all of the major import suppliers are facing similar issues with regard to ever-eroding margins. Although quick advances in market share might seem appealing to some of the smaller players, it is the responsibility of the MNC Life Science suppliers, domestic distributors, and our good customers in India to help maintain a strong value for our high technology products and resources we employ to support them. Our customers in the Indian market must continue to recognize that in order to provide the newest advances in separation science to the Indian market; customers must be willing to make the investment for these solutions to their most challenging separations. The alternative can lead to disastrous consequences for the export-oriented Indian firms capturing global market share. If the quality of these products comes into question because of the lack of validation of proper testing platforms provided by internationally recognized MNC's in the Life Science market, a key segment of the Indian export economy could be at risk.   How do you see Korea as an emerging market for Phenomenex? Which are the other global territories that Phenomenex is willing to explore, invest and establish? Phenomenex's business is increasing throughout the Asia Pacific region. Strong distribution relationships coupled with the addition of the Phenomenex India office to contribute local support (resources for technical and product related inquiries) are strengthening our footprint throughout the region. Brazil, Russia, and China are, of course, three other countries showing significant growth. What are the expansion plans charted out by Phenomenex? How is Phenomenex planning to expand within the Indian sub-continent? As Phenomenex India prepares to enter Q3 of our third year in business here in India, we are continuing to expand on our original position for moving direct into the Indian market, namely unparalleled customer service and support. To that end, we have strived to hire the most astute and technically trained application specialists in our industry. Further, we have promoted technical seminars throughout all of the major markets in India, and within the last year we have given technical presentations in some of the smaller Tier Three cities, where attendance at hotel seminars has been fantastic. Compliment these technical seminars with on-site demonstrations, where our trained scientists actually stand side-by-side with our customers during their challenging method development activities and help them to implement our latest technologies, and the awareness to this new level of support is clearly beginning to be recognized by our customers. Further to these initial advances, we now have our sights set on satisfying some of the more recently emerging market segments, namely food and beverage (safety and quality), environmental, and energy (mainly petrochemical and other Gas Chromatography [GC] related application markets). Who are your competitors and how do you manage to handle fierce competition in the Indian market? Our major competitors in India are primarily the same as those we compete with throughout the rest of the world, namely Waters Corporation and Agilent Technologies. Additional competition in the market comes from a few of the European and Japanese firms that used to hold reasonable market shares in the western world ten to fifteen years ago, and at that time put more focus on capturing market share in the developing Asian laboratories. At the same time (late 1990s and early 2000), Phenomenex put an incredible amount of our resources into research and development, and for the past five years we are truly seeing the fruits of our investments. In both the mature markets of the west, as well as those in the emerging Asian region, our "first in class" products are gaining incredible momentum. Since 2006, Phenomenex has won no less than seven "R&D 100 Awards" for new and innovative products (across all major product lines; namely Liquid Chromatography, Gas Chromatography, and Solid Phase Extraction) and these new advances coupled with our unparalleled customer support are helping the organization reaffirm our position as the global leader in separation science consumables. What kind of growth do you see for your industry in the middle of a recession hit market? There is no doubt that the global recession has affected all of us in the life sciences arena-and Phenomenex is no exception. However, because of our corporate culture, we were well prepared for these tough times as far back as 2008, when our senior leadership predicted these market changes and prepared us for the coming storm. As macro-economic pressures have decreased business in the west, we have realigned some of our European offices to be even more productive and cost-conscious than ever before. Our corporate officials have learned from our European expansions of the late 1990s and through 2010, and we are building on this knowledge-base for the most efficient and practical advances into the Asian markets. Conscientious spending, cost control, and accurate return on investment predictions are critical components to each and every investment we consider today. What are your latest innovations and product creations? Any new patents filed/received? Although the product line is now reaching approximately five years since inception, our Kinetex Core Shell Technology UHPLC columns are still introducing new phases across an entire range of particle sizes, from the smallest and most efficient particle in the market (1.3 micron) to the incredibly popular and widely used (5 micron) offering, this newest LC column technology is gaining traction faster across the globe than any we've ever seen. Some of the other products that are also gaining acceptance in the bio-separation market are our Aeris and Yarra HPLC column lines, and our Phree Phospholipid Removal Products in the solid phase extraction category. Recently, the FDA's new guidelines on conducting clinical trials emphasizes that FDA now will not insist on 100% on-site inspection of clinical trials by sponsors. FDA has said that inspection needs to be done only in sites where there is potential risk of data manipulation. What is your opinion on this? Please elaborate. Phenomenex is tracking the FDA's guidelines put forth toward our customers in the clinical trials arena very carefully to assure our customers the full support we can afford as it relates to supporting the use of our product technologies. As an ISO-9000 certified organization, Phenomenex clearly recognizes that changes in compliance are a regular part of doing business globally. Our teams of Quality Control and Quality Assurance professionals in Torrance, California, have proven that self-analysis and internal inspection afford continuous improvement of the organization. Are there any advantages to the above new guidelines of FDA? Explain. These guidelines will ensure a level of quality across the industry that will necessarily weed out any companies that are not committed to the highest levels of quality throughout the drug development and approval process. As Phenomenex is naturally aligned to doing business in this way, it sets the stage for easy acceptance of new regulations, and it positions us to help our customers that are interested in a similar end-game. What are your major current areas of investments? Phenomenex's major investments are in expanding research and development activities, increasing production capacity for some of our high-value medias, and further advancing column packing techniques and other novel formats for these unique medias. We also continue to invest in Phenologix, a method development services group introduced to offer solutions to our customers' most challenging separation science applications. And, we continue to make big investments into further refining the customer experience. Specifically, we have committed a tremendous amount of capital and resources to the Phenomenex website and other e-platforms which will allow customers to streamline their interactions and enjoy the best possible customer experience our industry has to offer. Can you elaborate on the profits achieved by Phenomenex in the Indian market in 2013 so far? Phenomenex India is here for the long journey ahead with our customers in the Indian market. We have made significant investments in formalizing our Indian operations, and we are still in the early steps of the journey. That being said, we are hopeful that those that are responsible for the continued growth of the Indian economy do not lose sight of the global market beyond our borders and begin to take the necessary steps to improve the domestic economic conditions to make India a nation of choice for continued pharmaceutical and biotechnology innovation. Strengthening of the rupee, more open-mindedness toward global collaboration, and a renewed effort to reach international consensus on intellectual property issues will all help India to keep its place among the most rapidly expanding nations in pharmaceuticals, biotechnology, and life science sectors. What is Phenomenex looking forward to by the end of this year? Phenomenex India looks forward to celebrating another strong year of strong customer service and support leading to increased business development within the Indian market. We look forward to meeting with our loyal customers at both the Analytica Anacon India in Mumbai in November and at the Indian Pharmaceutical Congress in Delhi in December, and we look forward to establishing new relationships with customers that are just getting to know us for the first time. ]]> https://biospectrumindia.com/news/97/7670/quintiles-recognized-for-leadership-in-business-technology-in-information-week-500.html https://biospectrumindia.com/news/97/7670/quintiles-recognized-for-leadership-in-business-technology-in-information-week-500.html Wed, 11 Sep 2013 13:13:00 +0530 Quintiles has been recognized for its leadership in business technology innovation with its inclusion in the Information Week 500 for the fifth consecutive year. "A cloud-based solution fully integrated with regulatory agencies around the world, Infosario Safety simplifies processes and eliminates the fragmented technology and vendor complexities associated with running an efficient, high-quality pharmacovigilence operation at any drug company," said Quintiles Chief Information Officer Richard Thomas. Quintiles created an industry-wide platform, Infosario Safety, which addresses the challenges of managing drug safety to improve patient outcomes and drive compliance with changing regulatory requirements while enhancing quality and productivity across a product's lifecycle. "Creating something new and of high value is never easy. This innovation accolade puts a spotlight on the team of Quintiles professionals who came together and envisaged an industry solution to a complex series of challenges - testament to them that they then went on to deliver it," Thomas added. Over the past five years, InformationWeek has recognized Quintiles for numerous industry leading business technology innovations across the drug development continuum. These innovations are key components of Quintiles Infosario, an end-to-end, cloud-based platform for drug development. Built on industry standards and in close collaboration with some of the world's leading organizations in the pharmaceutical industry, Quintiles Infosario eliminates IT complexities and empowers researchers to focus on making data-driven decisions at every step of the way.   InformationWeek identifies and honors the nation's most innovative users of information technology with its annual InformationWeek 500 listing, and also tracks the technology, strategies, investments and administrative practices of some of the bestâ€?known organizations in the country. "The theme of this year's InformationWeek 500 is digital business. It's a movement rooted in data analytics, mobile computing, social networking and other customerâ€?focused technologies that are turning companies and industries on their ear," said InformationWeek Editor In Chief Rob Preston. "Every enterprise is now a digital business - or needs to become one fast. The companies in our ranking are leading the way." ]]> https://biospectrumindia.com/features/97/3365/caught-in-crossfire.html https://biospectrumindia.com/features/97/3365/caught-in-crossfire.html Tue, 10 Sep 2013 16:47:00 +0530 As per records of the Drugs Controller General of India (DCGI) in the Supreme Court, India approved 475 clinical trials for 'new chemical entities' not used as drugs elsewhere in the world between January 2005 and June 2012. Further, the documents submitted by the DCGI claim that 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. They put deaths from trials at 2,644 over the last five years. The mainstream media reports from time to time displaying prominent headlines on the clinical trial deaths, have brought a bad name to the industry. And experts also lament that most of these alleged deaths are not even actually related with the trials. It is now clear that as far as opening a dialogue and establishing trust is concerned, there a big disconnect between civil society and industry. While the civil society and media representatives say that its their duty to uphold the human rights, Dr Renu Razdan, chief operating officer, Max Neeman International feels that hype and sensationalism won't do any good. She says, "Unfortunately, the regulatory response to such media reports has been reactive making the e-regulatory process for clinical trials slow and uncertain. There is also a lack of transparency and consistency which is a cause of concern for the clinical research professionals in the country." The availability of volunteers which was once feared to be a major concern is now no longer among the immediate issues. Few industry experts feel that word 'volunteer' in this context is flawed in itself. "People participate for money. With high compensation there is no dearth of healthy subjects," remarked a prominent person from industry. He added further, "It was never and will never be a variable hampering clinical trial growth in India. India never lacked the availability of volunteers for doing trials. In fact, the availability of volunteers will always hinge upon the proper and scientific counseling of the patient to take up decision about being a part of clinical study or not." India has always followed the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use- Good Clinical Practices (ICH-GCP) processes for informed patient consent. The document "Informed Consent Form" has all the detailed information written in layman and local native language for easy understanding and comprehending the information. Aaditya Vats, manager-regulatory affairs, Excel Life Sciences feels that informed consent is an education and information exchange process between investigator, the subject and their family. "The entire process of consenting gives adequate time and opportunity to the subject to consider all alternative options, consult with family, colleagues and physicians before taking the voluntary decision to participate in the study. Hence with the current documentation practice, if practiced, I don't see any reason for concerns over patient consent," he said.   Recently the recent draft gazette from ministry of health has contemplated the recording of the entire patient consent process through audio /video by the CDSCO office. But now it being a law for study subject to participate in the study, few are pointing towards challenges in terms of maintaining confidentiality of the subject and logistics of recording etc. "While this is a welcome move, it will have its own set of challenges in execution, including protecting patient identity, review of informed consent tapes, consent for video consent etc. While defining clear cut processes is one part of resolving the problem, the other more important part is rigorous execution and oversight. One can only wait and see if this move will have a long term impact," says Nidhi Saxena, chairman and chief executive officer, Karmic Life sciences. Agreeing Dr Mita Nandy, chief operating officer, Fortis Clinical Research, feels more positive about the change. She says, "In India  mostly the patients with low socioeconomic stature to obtain treatment benefit  participate in trials. This is fact and hence inducement is doubted by foreign sponsors or regulatory bodies. To take care of this consent process should be taken in details using audio video recording which will definitely help to obviate the doubts global sponsors/regulators have regarding the consent process in India." Recently during a workshop on regulatory changes, organized at Jamia Hamdard University, various industry experts had expressed their resentment against what they called lack of clear decision making on part of DCGI's office. Notwithstanding the criticism, Dr GN Singh had clarified that though there are challenges but that doesn't mean that regulator can take only one sided approach. He had maintained that efforts are on to build the required manpower and infrastructure in due time to mitigate the concerns. He also had pointed toward the lack of staff (especially drug inspectors) at the regional regulatory offices as well as the CDSCO. Meanwhile recently, the organization has recruited close to sixty new inspectors and are also looking at strengthening the manpower and infrastructure. DCGI's office has also started meetings with the various stakeholders to since January this year. On being asked about the same, Dr Singh had told BioSpectrum, "I wanted to get updated on the reactions of patients and all the other stakeholders on the clinical trial system. In that direction, we initiated meetings with common people, manufacturers and civil society members from time to time. Since the civil society represents the aspirations of people, we would like to work closely with them. In fact, the mistrust that existed earlier has evaporated gradually. I think this is the time to build up expectations and regulator must know that. It is the high time to build up the confidence among the public that we are there." With reference to minutes of the Drug Testing Advisory Board (DTAB) meeting held on May 16, 2013 which discussed the compensation guidelines, the Indian Society for Clinical Research (ISCR) in its statement mentioned, "This is an encouraging development and we are glad that the regulatory bodies are addressing the concerns of all stakeholders. Collaboration, transparency and open dialogue are important to ensure the progress of the industry, while securing the rights and safety of patients."The president of ISCR, Susheela Thatte, mentioned, "We believe the media can play an important role in highlighting the impact the new rules are likely to have on clinical research in the country and particularly the innovative, indigenous research that is being carried out in several academic institutions and teaching hospitals." At present, we are just a miniscule part of global trials. This is despite the fact that our country accounts for about sixteen percent of the world's population and close to twenty percent of the global disease burden. Hence, there should be little doubt that the sector cannot be ignored anymore due to the standoffs between various stakeholders. Time is right to open have much better and effective communication channels and quick response mechanisms to mitigate the concerns of all of them. The industry too has to make efforts to undergo an image makeover by making connect with people and be humanitarian in its approach. Lack of clarity on new regulations? â–  Injury occurring to the clinical trial subject be given free medical management as long as required.â–  Any injury or death shall be treated as clinical trial injury or death and entitled for financial compensation. â–  Absence of arbitration mechanism in case of disagreement on causality/quantum of compensation.â–  On who shall be in the expert committee constituted by the licensing authority. Way out â–  Establishing a progressive regulatory framework incorporating patient care. â–  Subject compensation and clinical trial norms and uniformity with globally established standards. â–  Better clarity on the compensation rules and ethic committee. â–  Entering into a mature dialogue with media and activists. ]]> https://biospectrumindia.com/news/97/7358/merck-millipore-india-partners-with-toshvin-analytical-for-lab-water-purification-systems.html https://biospectrumindia.com/news/97/7358/merck-millipore-india-partners-with-toshvin-analytical-for-lab-water-purification-systems.html Fri, 06 Sep 2013 15:04:28 +0530 Merck Millipore India Private Limited (MMIPL), a division of Merck KGaA, Darmstadt, Germany, recently announced its partnership with Toshvin Analytical Pvt. Ltd. (Toshvin), to enhance capabilities and provide comprehensive services through their laboratory water purification system to customers in the Western and Central regions of India. The Merck Millipore water purification systems, namely Elix® and Milli-Q®, are designed to produce pure and ultrapure water purification solutions for high end research and pharmaceutical industries. The partnership is expected to build Merck Millipore's brand of laboratory water purification systems in these regions. Commenting on this partnership, Mr. Vivek A. Parachur, Director Lab Water, MMIPL said, "With over two decades of expertise in providing pure water solutions to laboratories across India, Merck Millipore has a dedicated service network that offers comprehensive after sales and validation support to customers. In Toshvin Analytical, we have found a partner that is aligned with our business strategy. Toshvin's experience and customer orientation will enable us to provide wide-ranging support to our customers in Western and Central India". With Toshvin as a strategic channel partner for sales and service in Maharashtra (except Mumbai, Navi Mumbai and Patalganga) and Andhra Pradesh (except Hyderabad and Secunderabad), Merck Millipore will be able to provide customers with an enhanced service offering. Mr. Nakul Toshniwal, Managing Director - Toshvin Analytical Pvt. Ltd. said, "We are pleased to enter into this parternship with Merck Millipore, the world's leading manufacturer and supplier of laboratory water purification systems. Toshvin is a pioneer and a leading player in this sector; having introduced analytical instruments to India over sixty years ago. With our strong presence in the analytical instrumentation industry, commitment to after sales support and experience in the laboratory water purification area, we look forward to expanding Millipore's customer base and supporting existing users of Millipore systems in the western and central regions."   ]]> https://biospectrumindia.com/news/97/4373/eppendorf-expands-its-plates-portfolio-with-the-launch-of-assay-plates-.html https://biospectrumindia.com/news/97/4373/eppendorf-expands-its-plates-portfolio-with-the-launch-of-assay-plates-.html Thu, 05 Sep 2013 13:44:00 +0530 Eppendorf, a leading life science company has expand its plates portfolio with the launch of eppendorf assay/reader plates.These plates are otimized for measuring absorbance assays in the visible and UV range, fluorescence and luminescence assays. Attributing to this fact clear plates and black clear plates can be used with top and bottom reading plate readers. The black Eppendorf Microplates are suitable for fluorescence detection. An excellent signal-to-noise ratio provides low detection limits in assays for clear signals even with low concentration samples. Apart from this the white Eppendorf Microplates maximize reflection for high sensitivity during detection of luminescence or weak fluorescence signals. Combination of Eppendorf plate reader AF2200 and assay/reader plates will provide a complete solution for most of the regular assays. Eppendorf products are most broadly used in academic and commercial research laboratories, such as in companies from the pharmaceutical and biotechnological as well as the chemical and food industries. ]]> https://biospectrumindia.com/news/97/5815/doctors-to-receive-medical-update-in-real-time-to-avoid-time-in-an-emergency-situation.html https://biospectrumindia.com/news/97/5815/doctors-to-receive-medical-update-in-real-time-to-avoid-time-in-an-emergency-situation.html Thu, 29 Aug 2013 17:35:00 +0530 More often than not in an emergency situation like accidents or brain haemorrhage the patients need immediate medical attentions however there is considerable time that is lost to conduct the preliminary checkups that result in untimely death of the patient who could possibly be saved. This is due to lack of communication between different point-of-care devices and clinicqal information systems. There are too many types of protocols and interfaces that are being used by hospitals, lack of proprietary data and inability of interoperability. With the introduction and implementation of remote access informationdevices that are accessible and has the ability of interoperatibility from any remote place and transmit data at any given time will result in saving lives in case of emergency situation. Prisma Global limited introduces a product called Medibox or MDS3. Built with advanced Prisma Global technologies inside, this small but highly capable system incorporates leading-edge features. It provides better connectivity between doctor and the patient. Prisma MDS allows the doctor to check the measurements whenever they need to access it. In addition to remote accessibility, remote monitoring can support more timely, safe and extensive care of patients health. Prisma MDS connectivity provides vital data to service providers such as Blood pressure, blood glucose, Electronic cardiogram, Weighing scale, Pace maker and body temperature from patients residence. On the other side Prisma MDS is also connected with server and modem which is again linked with Tele Medicine Centre that shares the data with Tele Medicine Terminal where clinician can easily check patients measurements. ]]> https://biospectrumindia.com/features/97/4321/global-biotech-industry-not-yet-out-of-woods.html https://biospectrumindia.com/features/97/4321/global-biotech-industry-not-yet-out-of-woods.html Thu, 22 Aug 2013 16:38:38 +0530 Ernst & Young has been producing annual reports on the state of the biotechnology industry for 27 years, and through most of that time, the industry has been unprofitable in the aggregate. In any given year, the earnings of the relatively small number of profitable companies were overshadowed by the net losses of the much larger pool of emerging, R&D-phase enterprises. This began to change in the early-to mid-2000s, when high double-digit revenue growth and the overall maturation of the industry began to move the sector closer to aggregate profitability. While largely symbolic, the industry's move to aggregate profitability was an indicator of its strength and stability. All of that changed when the global financial crisis hit in late2008. As companies reacted with extensive cost-cutting measures, the industry moved firmly into the black for the first time. Yet, there was little to celebrate in this historic achievement. Biotech had become profitable almost overnight not because of a huge uptick in product sales or the rapid maturation of scores of new leaders, but because large numbers of companies had been forced to slash costs simply in order to survive. Rather than being a sign of the industry's strength and stability, biotech's overall profitability had become a by-product of uncertainty and weakness says the report. ]]> https://biospectrumindia.com/features/97/4156/top-20-biosuppliers-2013.html https://biospectrumindia.com/features/97/4156/top-20-biosuppliers-2013.html Thu, 22 Aug 2013 15:58:00 +0530 ]]> https://biospectrumindia.com/news/97/3016/new-bd-biosciences-cell-analyzer-enables-complex-multicolor-experiments-in-disease-research.html https://biospectrumindia.com/news/97/3016/new-bd-biosciences-cell-analyzer-enables-complex-multicolor-experiments-in-disease-research.html Thu, 22 Aug 2013 11:58:00 +0530 BD Biosciences, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, recently announced the launch of the BD LSRFortessaTMX-20 Cell Analyzer, the latest in its line of high-performance research flow cytometers. The BD LSRFortessa X-20 Cell Analyzer delivers high-performance multicolor analysis with the most compact footprint in its class at just 30" x 29" (76.2 X 73.7 cm) and a height of 30" (76.2 cm). Recognizing that space is a valuable commodity in today's research environment, BD Biosciences designed the BD LSRFortessa X-20 Cell Analyzer to be compact without compromising the power needed. Offering a new level of flexibility, the analyzer can be configured with up to five lasers to detect up to 20 parameters simultaneously. While popular laser choices include blue, red, violet, yellow-green and UV, a wide range of up to 34 available laser choices are available as excitation sources. Each excitation source is supported by new polygon detector arrays, and each polygon can support up to eight detectors for maximum flexibility in optical configuration. The BD LSRFortessa X-20 Cell Analyzer is designed by BD's special order program that enables customers to configure BD flow cytometers and cell sorters to fit precise research and assay needs. This program is tailored to meet the needs of researchers at the leading edge of biomedical discovery. The platform is also supported by a full range of BD Biosciences reagents. "The new BD LSRFortessa X-20 Cell Analyzer will enable researchers to conduct complex experiments with the additional parameters and increased sensitivity they need," said Alberto Mas, President, BD Biosciences. "Uncovering dim staining and rare cell populations is extremely valuable to complex multicolor assays, which are tools for advanced disease or drug development research." BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. ]]> https://biospectrumindia.com/news/97/7979/transasia-bio-medicals-ltd-conducts-hands-on-training-on-various-biochemistry-instruments.html https://biospectrumindia.com/news/97/7979/transasia-bio-medicals-ltd-conducts-hands-on-training-on-various-biochemistry-instruments.html Wed, 14 Aug 2013 13:46:00 +0530 As a first step in the direction to affirm that the consumers have a hands on with applications and operations to provide precise result, Transasia Bio-Medicals Ltd initiated a 'Biochemistry Medical Technolgists Training Programme' in different cities across India like Mumbai, Baadi to name a few. The training was attended by technologists from laboratories and hospitals. The programme was organised with an objective to introduce Good Laboratory Practices (GLP). The technologist were offered with training on automation and the entire range of biochemistry instruments. The expert team of product managers and scientific personnel from Transasia conducted technical and hands on training on various biochemistry instruments like EM 100, EM 200 and Chem Touch. During the training, two levels of quality controls ERBANORM and ERBAPATH were run on EM 100 for three different chemistries namely Glucose (End point), SGOT/PT (Kinetic) and Creatinine (Tow point kinecti). The technologists were happy with the result and its precision boosted their confidence. For further reference, the participants were handed a training kit comprising of informative material.   ]]> https://biospectrumindia.com/features/97/8445/slow-down-in-growth-for-biosuppliers.html https://biospectrumindia.com/features/97/8445/slow-down-in-growth-for-biosuppliers.html Tue, 13 Aug 2013 17:07:00 +0530 ]]> https://biospectrumindia.com/news/97/2962/new-device-for-rapid-semi-dry-transfer.html https://biospectrumindia.com/news/97/2962/new-device-for-rapid-semi-dry-transfer.html Tue, 13 Aug 2013 14:00:41 +0530 Fisher Scientific launches new Thermo Scientific Pierce G2 fast Blotter, designed especially for rapid 5 minute or traditional i hour. The new device is efficient for small, medium and large proteins. The new product has been designed in such a way that it has integrated power supply for seamless control and easy touch programming for any protocol. With the help of this product easily transfer upto 4 mini gels or 2 midi gels at a go can be done. ]]> https://biospectrumindia.com/news/97/8184/eppendorf-launches-sophisticated-cell-imaging-consumables.html https://biospectrumindia.com/news/97/8184/eppendorf-launches-sophisticated-cell-imaging-consumables.html Thu, 01 Aug 2013 18:25:00 +0530 Eppendorf - with over five decades of experience in development and manufacturing of consumables for life science laboratories, now extends its portfolio further with the launch of Cell Culture and Cell Imaging range of consumables. The Eppendorf Cell Culture product range is now being extended with  tailor-made solutions for live cell imaging, and fluorescence-based analysis.The Cell Imaging consumables comprise of Dishes, Plates, Chambered Cover-glasses and Chamber Slides. These products are made to provide superior performance for adherent cells due to innovative TC-treatment technology during production. The Eppendorf 24- and 96-Well Cell Imaging Plates are acquirable with glass and/or foil bottoms. These are ideal for applications which involve exceptional planarity and optimal oxygen transfer rates. Novel & Unique design of the Cell Imaging Dishes with its central reservoir cavity help reduce costs of media, antibodies and dyes for defined growth and staining of cells. Eppendorf Cell Imaging Slides and Cover-glasses with its enhanced chemical resistance caters to all the current fixation protocols used in cell biology. ]]> https://biospectrumindia.com/news/97/3426/rd-magazine-honored-acquity-upc2-.html https://biospectrumindia.com/news/97/3426/rd-magazine-honored-acquity-upc2-.html Wed, 31 Jul 2013 16:51:00 +0530 Waters Corporation (WAT: NYSE) declared that R&D magazine recongnized the Waters ACQUITY UPC2 system as one of the most technologically significant product introduced in the marketplace over the past year. The ACQUITY UPC2 System is the first in a new class of separations tools based on the technology of UltraPerformance Convergence ChromatographyTM (UPC2). "We are overwhelmed that the ACQUITY UPC2 system was applauded by the R&D magazine 51st annual R&D 100 Awards", told Art Caputo, President, Waters Division. Further he added "Since its introduction , ACQUITY UPC2 adoption spans all the markets we serve - including pharmaceuticals, food, environment, chemical materials, and clinical research applications."  The sysytem is competing along with liquid and gas chromatography as one of the three integral technologies for modern laboratory analysis. As an orthogonal technique to LC and GC, the ACQUITY UPC2 System is an efficient, robust, and reliable technique that employs compressed carbon dioxide, rather than organic solvents, as the primary mobile phase constituent and thus is a greener alternative for many applications - both chiral and achiral - across many industries.The technique is said to be suitable for a diverse range of compounds including most organic soluble compounds, salts of organic acids and bases, small lipoohilics peptides and non-polar solutes. Laboratories accessing the technique at present are realising it to be ideally suited for chiral separations and a great substitute for solvent-hungary normal phase LC. So far Waters has won six previous R&D 100 awards. The annual R&D 100 award competition organised by R&D magazine honors 100 most technologically significant products introduced in the past 12 months.   ]]> https://biospectrumindia.com/features/97/5320/indispensable-chromatography.html https://biospectrumindia.com/features/97/5320/indispensable-chromatography.html Wed, 24 Jul 2013 17:45:00 +0530 The estimated Rs 1,300 crore strong chromatography market continues to hold a major chunk of total biosupplier market revenue. The market continues to grow at a rate of 20%. Dominated by High Performance Liquid Chromatography (HPLC), the chromatography market also includes the important sub-segments such as Liquid Chromatography (LC), Gas Chromatography (GC) and Ultra-high performance liquid chromatography (UPLC). The Agilent Technologies and Waters equally control around 70% of the market, followed by Shimatzu and Thermo Fisher having strong presence in the segment. Few of the other significant players include the Daicel, GL Sciences, Grace, Machery Nagel, Merck, Phenomenex, Sigma Aldrich, Whatman, YMC etc. The overall analytical instruments market said to be close to Rs 6,000 crore by experts, has also showed consistent growth over a period of time. The growth drivers for this market include the govt investments in academics, life science applications-'Omics', growth in generics and CROs and therapeutic conversion to new biological entities. While the life science applications in pharma biotech and environmental industries account for close to 80% of the market revenue, 10%. each is shared by national laboratories and other government institutes. The total HPLC market of India is estimated to be around 600 crore, witnessing a growth of over 15% for fiscal year 2011-12. The tremendous increase in the number of quality control, method development, research and drug discovery laboratories has been the driving force for the HPLC market. Another sub segment, Ultra-high-pressure liquid chromatography (UHPLC) due to its advantages in chromatographic resolution, speed, and sensitivity over conventional HPLC systems, has been increasing its presence substantially. This particular sub segment is said to gain another 5%-10% of the market in the next 2-3 years. The Indian Ion Chromatography (IC) market is quite small as compared to but is rapidly increasing at an estimated rate of 20 %. The same is attributed to its usage in environmental monitoring. Dionex Corporation holds the major low end market is shared between Dionex and Metrohm. The Gas chromatography is said have grown at the rate of 6% in 2011. The dominant player includes Chemito followed by Agilent, Perkin Elmer, Shimadzu. Thermo The visible trend in this segment is the gradual shift towards GC-MS. The technological advancements with advent of systems for faster analysis have also opened up newer opportunities of growth notably ultra-high performance liquid chromatography (UPLC), monolithic columns and hydrophilic interaction chromatography (HILIC). UPLC has rapidly grown out of its infancy and moved into the analytical labs. Monolithic columns also hold great potential for very fast separations. Waters introduced Acquity UPLC in 2004, using columns packed with particle sizes of 1.7 micron and advances in instrumentation designed to deliver 15000 psi. Agilent offers RRLC - Rapid Resolution Liquid Chromatograph mentioning that the method developed on a conventional HPLC can be transferred seamlessly to a RRLC. Shimadzu has launched UFLC - Ultra Fast Liquid Chromatograph offering high throughput but without high pressure. Dionex achieves Fast LC with Acclaim Fast column with UltiMate 3000 Intelligent LC. Thermo has launched Accela High Speed LC that has been designed to optimize performance of sub-two micron particle columns. Despite the possible adverse economic conditions, the government funding towards R&D is still expected to increase. Therefore the chromatography segment is expected to maintain at least the minimum of 15% growth rate in the current financial year as well.   Highlights: â–  Growing at an average 20% rate, HPLC constitutes major chunk of chromatography market. â–  Indian pharmaceutical industry contributes more than 65 percent for the HPLC market.â–  Waters & Agilent continue to dominate the segment. â–  UPLC is the fastest growing LC market segment.dominated by Waters (60 percent) followed by Agilent (17 percent) and Shimadzu (8 percent). ]]> https://biospectrumindia.com/news/97/3072/vc-funding-in-healthcare-it-to-exceed-2-billion-in-2013.html https://biospectrumindia.com/news/97/3072/vc-funding-in-healthcare-it-to-exceed-2-billion-in-2013.html Mon, 22 Jul 2013 09:30:07 +0530 Mercom Capital Group, llc, a global communications and consulting firm, recently released its report on funding and mergers and acquisitions (M&A) activity in the Healthcare IT sector for the second quarter of 2013. According to the report, venture capital (VC) funding in the sector continued its rapid growth in another record quarter with $623 million raised. There were 168 funding deals this quarter compared to 104 the previous quarter and 163 in all of 2012. "VC funding in Healthcare IT is now on pace to exceed $2 billion in 2013," commented Raj Prabhu, CEO of Mercom Capital Group. "What government financial incentives did to spur EHR adoption and practice-focused technologies, "open data" is doing for consumer-focused companies that turn data into usable applications and services." The impact of healthcare data on innovation, products and private investments is evidenced in Mercom's Q2 2013 report. The marked shift of VC money going from practice-focused technologies towards consumer-focused technologies in Q1 has picked up pace this quarter with consumer-focused companies receiving twice the amount of funding ($416 million in 112 deals) compared to practice-focused companies ($207 million in 56 deals). Proteus Digital Health, a digital health feedback system provider, raised $45 million to make it the largest recipient of funding. lifeIMAGE, a network for securely sharing medical images and related health information, raised the second highest amount in the second quarter when it closed a $35.6 million Series C round. Blue Health Intelligence, a healthcare data and analytics company, raised $35.5 million. WorldOne brought in $35 million and Watermark Medical, closed out the Top 5 with $32.2 million.   The two disclosed M&A transactions in Q2 2013, included Jawbone, expanding its long line of recognizable wearable devices, which acquired BodyMedia, a maker of wearable health tracking devices, for more than $100 million. The other was Instem, a provider of IT applications to the early development healthcare market, which acquired Logos Holdings, a provider of full-service electronic data capture for clinical research organizations, along with its subsidiaries Logos EDC Solutions and Logos Technologies, for $7.7 million. A total of 161 investors participated in Q2 2013 including accelerators, incubators and crowd-funding platforms compared to 108 different investors in Q1 2013. Eleven investors participated in multiple funding rounds in Q2 2013. Ascension Health Ventures was the most active investor, and participated in three deals. The remaining top investors participated in two deals apiece. They included BlueCross BlueShield Venture Partners, AIB Seed Capital Fund, Cardinal Partners, Enterprise Ireland, Galen Partners, Khosla Ventures, Lemhi Ventures, Milestone Venture Partners, New Enterprise Associates, and SV Angel. Consumer-focused companies specializing in apps, wearable devices, sensors, remote monitoring, patient engagement, rating/shopping, and social health networks for physician-to-physician, physician-to-patient and patient-to-patient were all prominent this quarter, whereas medical imaging, data analytics and EHR/EMR companies were among the practice-focused technologies that received attention this quarter. M&A activity in the Healthcare IT sector dropped in Q2 2013 with 30 transactions of which only two were disclosed compared to Q1 2013, with 46 M&A transactions of which only five were disclosed. Health information management companies attracted the most acquirers with 14 transactions followed by service providers with seven acquisitions and mobile health with three in Q2 2013. ]]> https://biospectrumindia.com/news/97/7734/cole-parmer-launches-7th-annual-catalog.html https://biospectrumindia.com/news/97/7734/cole-parmer-launches-7th-annual-catalog.html Wed, 17 Jul 2013 11:49:00 +0530 A new resource is up for the laboratory staff and manufaturers to overcome day to day challenges. Cole-Parmer, with overall 50 years of expertise in fluid handling, life sciences, laboratory products, instrumentation and equipment came out with its 7th annual catalog for the Scientific and Process Industry. The new 2013/2014 catalog offers an widespread of products and services to be selected so as to enhance efficiency. Rakesh Aggarwal, Director, Cole-Parmer, India, quoted at the launch "The new 2013/2014 catalog strokes the company's laurel of bringing the latest, hard to find products to the users. It is customised in such a manner that product are placed based on features and areas of application." Featured products in the catalog include the Masterflex I/P Digital Process Drive, Oakton ph 700 Benchtop Meter, Rotational Viscometer, IKA EUROSTAR 100 Control Digital Mixer, Centrifan PE Small-Volume Evaporators, Cole Parmer POlystat Cooling/Heating Circulating Baths, Masterflex L?S Precision Modular Drives, Shuttle Portable Ultra-Low Temperature Freezer, and IKA RET control Stirring Hot Plate, and many more to add to to the list. ]]> https://biospectrumindia.com/news/97/7631/thermo-fisher-scientific-launches-new-small-benchtop-centrifuge-.html https://biospectrumindia.com/news/97/7631/thermo-fisher-scientific-launches-new-small-benchtop-centrifuge-.html Mon, 24 Jun 2013 17:26:00 +0530 Thermo Fisher Scientific has launched the new small benchtop centrifuge,which delivers, a compact footprint, the flexible to adapt to evolving clinical and research needs, including clinical chemistry, cell culture, microbiology and hematology. Featuring innovative Thermo Scientific technologies , the small benchtop apparatus is designed for solid reliability and consistent results to reduce the amount of downtime and costly bottlenecks during the separation process."Centrifuges are critical laboratory resources that are in constant use and demand. It is crucial to avoid bottlenecks in these lab work-flows that could create unwanted downtime and negatively impact users' work," said Maurizio Merli, product director, Thermo Fisher Scientific. "With features designed to optimize simplicity, safety and flexibility, the new Thermo Scientific small benchtop centrifuges can help scientists save time and maximize resources in busy labs and clinics." These small benchtop centrifuges provide application flexibility, cleaning convenience, and ease-of-use with Thermo Scientific Auto-Lock rotor exchange . It also have the versatility to spin blood tubes, conical tubes, microtubes and microplate compatibility with sealing options - all in one versatile unit. Furthermore , One-handed sample protection with Thermo Scientific ClickSeal biocontainment lids, certified by the Public Health Laboratory Service, Microbiology Services, Porton Down, UK. Intuitive glove- and detergent-friendly interface with a bright backlit display, featuring one-touch operation with pre-set protocol options and optional password protection Thermo Scientific, Fisher Scientific and Unity Lab Services, which offers a specific combination of innovative technologies, favorable purchasing options and a single solution for laboratory operations management. The products and services helps the customers to solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. ]]> https://biospectrumindia.com/news/97/7787/greater-emphasis-on-pharmacovigilance-will-increase-need-for-software-solutions.html https://biospectrumindia.com/news/97/7787/greater-emphasis-on-pharmacovigilance-will-increase-need-for-software-solutions.html Thu, 20 Jun 2013 15:24:00 +0530 Recently TAKE Solutions launched a new version of their proprietary software PharmaReady 5.0. The software involves regulatory document workflow submission for small and medium enterprises. TAKE Solutions says it has the local advantage, since this involves generic companies, those that have a good market share in India. Currently there are over 45 customers for Pharmaready 5.0 in India. Mr. Ram Yeleswarapu, president and Chief Executive Officer envisions that this number will increase with Indian manufacturers increasing their investments in drug safety and risk management. He adds, "Today, there is a greater emphasis on pharmacovigilance and Pharmaready is uniquely poised to allow customers to incorporate that. Currently very few adverse events are being reported, we want to provide tools to streamline the process and contribute to that." PharmaReady 5.0 recently included an option that allowed the entire process for submission of documents to the Saudi FDA in the NEEDS format. It has also built Arabic language prompt. This version has strengthened the hyperlinking and technology for documentation. In addition to providing IT services, TAKE solutions also has a data oriented CRO for the US and EU market for Phase I, Phase II and Phase III trials. They cover clinical, regulatory and safety functional coverage areas in addition to strategy consulting, technology solutions, business services, analysis etc. The services also include SAS data sets, data management, encompassing all components involved upto an NDA approval. Mr. Ram says, "Our role begins when the data is collected by the company and handed over. We offer services that are involved in the journey from I&D to NDA." TAKE Solutions offers services to deploy their partner's solutions, engage in co product development that is headquartered in Chennai and also offer cloud hosting environment for some of our customers. Oracle is one of their biggest portfolio partners when it comes to Life Sciences. Currently 70 percent of TAKE Solutions' revenues are from US/EU and the rest are from India. When it comes to biologics, Mr.Ram is hopeful, "So far, most of our work has been with regards to formulations and APIs. I believe we can add a tremendous value to other players in biologics and vaccines as well, however, we need to plan for that specifically."   Software solutions for regulatory submissions are currently compliant with USFDA, EMA, and Canadian regulatory agencies. When asked if they would expand these services in India, he says, "A discipline is required in terms of filings, before we do anything. However, it is a configurable solution. We have focused on the India market, however we do not have any customized solutions for Indian companies yet." In terms of future plans, TAKE Solutions is making efforts towards building Intellectual Property in terms of biology. They had also done case studies in supply chain management and hope to explore it further. In 2011 TAKE was recognized as a leader by IDC's MarketScape Worldwide Life Sciences R&D IT Outsourcing for 2011. It is headquartered in Chennai, India while its U.S. headquarters is located in Princeton, New Jersey. It has over 400 customers worldwide. ]]> https://biospectrumindia.com/news/97/3289/gvk-bio-usfda-collaborate-for-drug-repositioning.html https://biospectrumindia.com/news/97/3289/gvk-bio-usfda-collaborate-for-drug-repositioning.html Wed, 19 Jun 2013 16:07:50 +0530 GVK Biosciences today announced that it has licensed its popular SAR, PK and Toxicity Database (GOSTAR) to the US Food and Drug Administration (USFDA). The material transfer agreement forms the basis of collaboration in Drug Repositioning, wherein the initial focus will be to identify alternative therapeutic indications of marketed compounds for neglected and orphan diseases. GVK BIO developed a proprietary 'Drug Repurposing Platform' with eight different approaches to address the drug repurposing challenge. The platform will use data from GVKBIO proprietary databases such as SAR databases (GOSTAR), Biomarker database (GOBIOM) and other public databases. GOSTAR, a manually curated database, has been developed over the span of a decade by a team comprising of more than 200 scientists. The database and application is being used globally by pharmaceutical and biotechnology companies as well as academia and has been cited in numerous publications. GOSTAR contains over 6.5 million compounds manually curated through the manual screening of over 2.5 million patents and 400,000 journals and it also contains more than 18 million quantitative SAR points. Sreeni Devidas, Vice President, Business Development said "The collaboration with the USFDA is a validation of the utility of GOSTAR in multiple applications. Specifically the ROI generated by the use in Drug Repositioning is unparalleled. GVK BIO will work with the USFDA to further enhance the Repositioning and Repurposing workflow and make it available to the entire research community". GOSTAR is the final outcome after the integration of over fifteen individual databases, which includes the complete chemical space for ten of the popular biological targets. In addition to this, the MedChem Databases include all published and patented inhibitors against biological targets that exceed 6,500 in number. GOSTAR also has four Toxicity and Natural Products databases. Manni Kantipudi, CEO, GVK Biosciences said "Drug Repositioning is gaining traction in the industry and in academia, and is becoming a mandatory component of the Drug Development Process. The GOSTAR product will prove valuable in allowing researchers to use multiple Repositioning and Repurposing approaches and address multiple targets in parallel. We look forward to continue working and collaborating with the FDA with a view to further enhancing the utility of the product." ]]> https://biospectrumindia.com/news/97/3303/ge-healthcare-to-invest-2-billion-in-software-development-.html https://biospectrumindia.com/news/97/3303/ge-healthcare-to-invest-2-billion-in-software-development-.html Wed, 12 Jun 2013 15:15:00 +0530 GE Healthcare has recently announced its plans to invest $2 billion over the next five years to accelerate the development of innovative software for healthcare systems and applications. GE Healthcare has a long history in software with its Healthcare IT business; and this investment is designed to advance current and future offerings in order to address new and pressing operational and productivity challenges faced by healthcare organizations around the world. GE Healthcare will work closely with the GE Software Center of Excellence in San Ramon, California, - as well as at various research and development hubs around the world - to develop new software solutions. As the largest software developer within GE, GE Healthcare provides a wide range of medical imaging technologies, IT services, patient monitoring and diagnostic solutions, biopharmaceutical manufacturing technologies and operational and technological service solutions. Specifically, this $2 billion investment will be focused on maximizing asset performance; improving hospital operations management; improving clinical effectiveness; and optimizing care across entire populations. "GE is investing in software and analytics to better help our customers manage the operational complexity of the healthcare system," said John Dineen, President & CEO, GE Healthcare. "These new software solutions will look to connect caregivers in a meaningful way to the systems upon which they rely, enabling them to deliver better informed diagnoses and improved care." "Healthcare has always relied on 'big data,' and the need to understand data is even greater now. What is important is how we use data," he added, "providing the right technology that allows physicians to pinpoint the right diagnosis; match it to the right treatment; and make more informed decisions." The Industrial Internet is changing the way healthcare professionals work and GE Healthcare has already made big strides in developing software-based technologies and solutions that provide increased data, analytics, connectivity and insight into operational and departmental processes and workflows. Together, with the help of industry partners, GE Healthcare's 3000+ software engineers and GE's software Centers of Excellence across the globe, GE will provide flexible and connected software, data and analytics so caregivers have what they need to help prevent, diagnose, treat and cure new health challenges they face every day. As the industry shifts towards accountable and integrated care, faster, more accurate real-time information has never been more important. ]]> https://biospectrumindia.com/news/97/3292/cole-palmer-introduces-multiparameter-tester.html https://biospectrumindia.com/news/97/3292/cole-palmer-introduces-multiparameter-tester.html Wed, 12 Jun 2013 12:45:25 +0530 Cole-Parmer recently introduced Oakton Waterproof Multiparameter Testr 35-series Meters. This is a convenient pocket-sized meter that measures pH, conductivity, TDS, salinity, and temperature. The versatile OAKTON waterproof multiparameter Testr 35-series meters is perfect for water, wastewater, laboratory, and plant use.These pocket-sized meters have long-life pH electrodes and stainless steel conductivity sensors for a wider range of sample compatibility. The easy-to-replace sensor modules helps you save money, allowing you to reuse the meter body. It's convenient, fast, and simple-just dip, measure, and can scan through up to five parameters with the push of a button. There is no complicated operating procedures and no need to change sensors for different measurements. These meters offer multiple calibration options-choose single or multipoint, automatic or manual.Conductivity or TDS can be measured more accurately at varying temperatures with an adjustable temperature coefficient feature. Auto-ranging feature also makes it more convenient for users with applications across broad measurement ranges. The unique sensor design provides faster ATC response and faster readings. ]]> https://biospectrumindia.com/news/97/7925/quintiles-infosario-platform-wins-innovation-award.html https://biospectrumindia.com/news/97/7925/quintiles-infosario-platform-wins-innovation-award.html Wed, 12 Jun 2013 12:15:50 +0530 Quintiles has received the prestigious 2013 Informatica Innovation Award for "Enterprise Data Integration" in recognition of its efforts through the Quintiles Infosario solution. The Infosario platform helps to integrate and master both clinical research and healthcare data across numerous institutions and at a larger scale than before. Quintiles Infosario seamlessly integrates data, systems, processes and Quintiles' therapeutic expertise to unlock faster, better-informed decisions from clinical trial planning and design to trial execution services, through post-market outcome studies. It uniquely allows for scientific and operational design to inform and optimize operations based on real-time alerts and data insights, mitigating risk, while improving patient safety, productivity and time to market. The Informatica Innovation Awards honors organizations that have demonstrated leadership through the application of Informatica technologies that yielded significant business results. Out of more than 5,000 companies and organizations, winners in 12 categories were announced at the annual Informatica user conference, Informatica World 2013. "We are honored to have Quintiles Infosario recognized as one of the world's leading data integration solutions," said Quintiles Chief Information Officer Richard Thomas. "At the core of Quintiles Infosario is our data factory which integrates a wide variety of clinical, healthcare and operational data across a significant number of sources ranging from pharmaceutical companies to hospital and care provider networks. Being able to combine this data and add context / meaning results in highly actionable analytics which our customers really appreciate" Thomas concluded. ]]> https://biospectrumindia.com/news/97/8073/-hp-deploys-virtual-health-platform-for-rural-india-.html https://biospectrumindia.com/news/97/8073/-hp-deploys-virtual-health-platform-for-rural-india-.html Mon, 03 Jun 2013 16:10:00 +0530 The World Health Organization (WHO) predicts that by 2020, mental illness will move from the 20th position to the second largest illness worldwide surpassing physical ailments like polio and tuberculosis. Therefore, with a population of over one billion, and a vast geography, it is difficult for skilled medical professionals to penetrate and address the scale of psychiatric healthcare delivery required in India. Working in this direction, HP has launched a new initiative on June 01, 2013, to improve access, quality and efficiency of global health, facilitates psychiatric care without requiring either the doctor or the patient travelling to meet each other. HP will network a central hub with remote smaller centers as well as provide a specially outfitted virtual health van that will enable delivery of remote consultations in rural towns and villages. The central hubs will be connected via voice, SMS, imaging, and videoconferencing technology to once-a-week clinics in smaller centers that would be temporarily established. The hub will be equipped with an IT platform that will link with medical diagnostic equipment such as digital stethoscopes and digital ECGs to facilitate remote patient diagnosis and medical consultation. "At HP, social innovation is at the heart of our business, and we are committed to applying our technologies, resources and expertise to address complex world problems and make a positive difference," said Commander Girish Kumar, Practice Head, India - Healthcare & Life Sciences, HP Enterprise Services. "In India, it is estimated that only 10 percent of mental health patients receive active psychiatric assistance or help.1 The virtual health technology solution aims to improve efficiencies in delivery of quality psychiatric care to under-served rural, semi-urban and remote areas in India," he added. HP is piloting the platform with MSC Trust, a leading NGO specialised in providing psychiatric solutions to patients in rural Tamil Nadu in south India. HP's virtual health platform will support MSC Trust's efforts to extend the reach of psychiatric care in rural India by providing the required Information technology infrastructure and improving awareness through continued education of medical personnel onsite. "Psychiatric illness carries a heavy stigma and treatment in rural parts of the country is often based on religious beliefs and superstitions. Technology plays a critical role in enabling proper medical treatment, such as early diagnosis and intervention, which can significantly improve the efficacy of the treatment and medication." said Dr. C. Ramasubramaniam, Founder and Consultant Psychiatrist, MSC Trust. A similar set-up is also being deployed in an air-conditioned virtual health van that will serve as a mobile clinic to provide remote consultation through video conferencing and digital diagnosis in remote rural parts of Tamil Nadu. A mobile based application called Medication Alert & Adherence System (MAAS) has also been co-developed by HP's Enterprise Services team in consultation with HP Labs. It uses mobile phones to monitor a patient's medicine intake. MAAS issues SMS reminders to the patient or their caregiver, based on the doctor's prescription which is stored in a central Health Information System. The patient's affirmative or negative intake response can be recorded and transmitted via SMS and subsequently serves as data that can be used for clinical observations, outcome analysis and to determine drug efficacy. ]]> https://biospectrumindia.com/news/97/2964/indian-laboratory-analytical-instruments-market-worth-762-5-mn.html https://biospectrumindia.com/news/97/2964/indian-laboratory-analytical-instruments-market-worth-762-5-mn.html Fri, 24 May 2013 16:58:00 +0530 An analysis of the Indian laboratory analytical instruments market, by Frost and Sullivan has shown that the demand for customized instrumentation from end-user segments such as the pharmaceutical and drug delivery sectors is driving the laboratory analytical instruments market in India. Regulations mandating quality assurance activities, especially in the pharmaceutical sector, further accelerate the market's growth. The study has estimated market earned revenues of more than $762.5 million in 2012 and estimates this to reach $2,370.0 million in 2018. The end-user segments covered in this research include pharmaceuticals and life sciences, government and academic research institutions, environmental safety, agricultural analytic research, third-party and food and beverage testing laboratories, and chemicals and petrochemicals. The research adds that government funding serves as the fulcrum for laboratory analytical instrument procurement in India; government institutions and research laboratories continue to be key customers for analytical instrument vendors. The untapped agricultural and contract research end-user groups offer added scope for laboratory analytical instrument manufacturers, and the agricultural sector's shift towards application-specific instrumentation in particular, will aid the market's steady year-on-year growth. "The increase in the number of contract research organizations in India, especially in clinical research management has led to achieve several contracts for manufacturing and research from other countries," said the analyst, Frost & Sullivan. Technological advancements in instrumentation, the creation and up-gradation of corresponding software platforms, and Research and Development (R&D) will propel the market further. Acquisitions and partnerships, which enable companies to enter niche segments and resist competition, will in turn, require technology developments and R&D, and open additional avenues for revenue generation. However, R&D costs are high and the inability of domestic small and medium enterprises, original equipment manufacturers, and distributors to meet these expenses, restrains market development. In addition, slow implementation of government laws and regulations in several consumer segments also dampen adoption process across different segments in this market.   The government, apart from strictly enforcing policies, must re-assess and reframe strategies to encourage manufacturing in India. Customized instruments to suit end-user requirements, and automation and hyphenation must be key areas of focus in the Laboratory Analytical Instrumentation space. "Multinational companies need to build a complete manufacturing and R&D ecosystem to stimulate job opportunities, rather than merely importing from their worldwide facilities," noted the analyst. "Academic institutions' increased interaction with end-user companies will close the gap between practical training at the academic level and the expectations of businesses operating in the lab analytical instrumentation market." ]]> https://biospectrumindia.com/news/97/2990/life-technologies-takes-over-advanced-microscopy-group-.html https://biospectrumindia.com/news/97/2990/life-technologies-takes-over-advanced-microscopy-group-.html Fri, 24 May 2013 16:40:00 +0530 Life Technologies Corporation, a global biotechnology company, recently announced the acquisition of Advanced Microscopy Group or AMG, a privately held developer of imaging systems for research microscopy incorporated as Westover Scientific. "This acquisition brings together two leaders in the cell imaging field," said Mr Peter Dansky, president of Molecular and Cell Biology at Life Technologies. "We're now better able to serve our customers with a complete portfolio of integrated solutions for cell analysis optimized for performance and ease of use." AMG has a portfolio of imaging instruments that spans basic to advanced microscopy. The EVOS range of instruments improves ease of use by eliminating conventional eyepieces and replacing them with LCD screens. AMG also developed Life Technologies' FLoid Cell Imaging Station, a platform that offers revolutionary ease of use for fluorescent microscopy. FLoid was developed to be ideally suited for laboratories that do not require the advanced features found in more expensive instruments. The EVOS product line complements the FLoid system by maintaining simplicity in the user experience, while providing advanced capabilities and automation that are necessary for some applications. The FLoid Cell Imaging Station is for research use only, not for use in diagnostic procedures. Mr Steve Lytle, founder and president of AMG said that "It is the customers who will ultimately benefit most from the breadth of the combined portfolios." The microscopy market size is estimated approximately $770 million. Life Technologies currently employs approximately 10,400 people and this acquisition of Advanced Microscopy Group promises increased job opportunities in the field of biotechnology. India a key market for Life Technologies Life Technologies recently conducted a three-city innovation update for researchers at New Delhi, Pune and Hyderabad, on May 17, 21 and 22, 2013 respectively. On being asked about the support from Life Technologies supporting biotech research in India, Mr Michael S James, director and research scientist from the US said, "In addition to increasing its local office, distribution, and support networks in India, Life Technologies continues to operate as "scientists working for scientists" in its approach to providing accessibility of the latest technologies to its customers throughout the region. Customer visits from R&D scientists, hands-on molecular probes/EVOS workshops, and web-based interactive tools for cell biology are a few examples of how Life Technologies is expanding its connections with scientists throughout India." Explaining the existing product portfolio, a senior official mentioned, "Life Technologies offers the complete solution for cellular analysis, enabling scientists to tell their 'cell story'. Market-leading technologies from growing cells with Gibco media, to modifying cells with Invitrogen and Ambion molecular biology solutions and Applied Biosystems thermal cyclers, to labeling cells with Molecular Probes reagents, and finally, to detection with EVOS, Tali and Attune devices."   ]]> https://biospectrumindia.com/news/97/6145/thermo-fisher-scientific-launches-energy-efficient-ln2-cryogenic-storage-solutions.html https://biospectrumindia.com/news/97/6145/thermo-fisher-scientific-launches-energy-efficient-ln2-cryogenic-storage-solutions.html Wed, 22 May 2013 16:21:01 +0530 Thermo Fisher Scientific has launched the Thermo Scientific CryoPlus LN2 series for long-term storage of frozen cells. Ensuring precise and accurate control over all parameters without complicated programming, the CryoPlus series' combines liquid nitrogen storage and microprocessor technology allowing complete reliability. The easy-to-use auto-filling technology provides user convenience, along with visual identification of LN2 levels. Available with storage capacities of 6,318, 13,000, 24,000 and 38,500 vials (2.0ml), the CryoPlus series is able to meet the storage and space requirements for any laboratory. Furthermore, super-low power consumption and no heat rejection provide environmentally-friendly benefits for today's "green" laboratories. The Thermo Scientific CryoPlus series features sensitive liquid level sensors located at the exterior base of the tank, which maximizes storage capabilities while minimizing sensor damage from inventory rack movement. The high-quality 18-guage, cold-rolled steel exterior cabinet has a uniform finish that resists chipping and rust. 16 preset audible and visual alarm combinations provide optimal product protection. Furthermore, a unique 24 tri-color LED element continuously displays the actual liquid nitrogen level and high-level/low-level setpoints, enabling easy visualization of the system status as well as any alarm conditions. Additionally, an automatic de-fogger is incorporated into the manual fill index to improve visibility during retrieval. Safe sample storage is facilitated through the use of vacuum insulation, minimizing the risk of condensation and ensuring that optimum temperatures are maintained. As such, the Thermo Scientific CryoPlus LN2 cryogenic storage series provide a consistently high-performance for the long-term viability of frozen cells. ]]> https://biospectrumindia.com/news/97/6261/quintiles-most-preferred-cro-for-phase-ii-iii-trials.html https://biospectrumindia.com/news/97/6261/quintiles-most-preferred-cro-for-phase-ii-iii-trials.html Wed, 22 May 2013 16:14:49 +0530 A recent report has indicated that Quintiles best differentiates itself on service quality in phase II/III clinical research. The Industry Standard Research's (ISR) 2013 CRO Quality Benchmarking Report - phase II/III, asked 157 pharmaceutical and biotechnology professionals, who rated Quintiles as the leader among large CROs for customer loyalty, defined by overall satisfaction, willingness to recommend and likelihood to use Quintiles again. "We are deeply committed to helping our customers increase their probability of success at every sage of the product lifecycle," said Ms Paula Brown Stafford, president, clinical development at Quintiles. "We are delighted to see that our leadership and commitment to both quality and customer satisfaction are recognized by the industry." According to the report, Quintiles is the best phase II/III clinical research service provider at differentiation based on service quality; Quintiles leads large CROs in customer loyalty and is the most cited industry leader. It also exceeds expectations for global reach, breadth of services, local regulatory knowledge, commercial market knowledge and the ability to consistently meet "First Patient In" timelines. Quintiles said that they are committed to transforming drug development through its data and proprietary knowledge engine, Quintiles Infosario, an innovative solution that seamlessly integrates data, Quintiles' systems, processes and therapeutic expertise to help customers make faster, more informed decisions. This recognition comes on the heels of Quintiles' award for Best CRO in Vaccine Industry Excellence presented in April 2013 at the World Vaccine Congress. ]]> https://biospectrumindia.com/news/97/3266/why-we-need-clinical-trials.html https://biospectrumindia.com/news/97/3266/why-we-need-clinical-trials.html Mon, 20 May 2013 18:33:00 +0530 Commemorating the huge impact that clinical trials have had on improving healthcare in the world, today, May 20, 2013 was celebrated as the International Clinical Trials Day. The day is celebrated in the honor of Dr James Lind, considered the originator of clinical trials, who started his famous trial to treat scurvy. Dr Lind carried out his experiment to study the efficacy of citrus fruits in preventing scurvy in 1747 while serving on board HMS Salisbury. All his scurvy patients were given the same general diet which was supplemented with various additional items that included cider, elixir vitriol, vinegar, seawater, nutmeg and oranges and lemons. In just six days, patients taking citrus fruits were fit for duty and Lind was able to establish the link between citrus fruits in the diet and the prevention of scurvy. As a part of the commemoration of this day, a panel discussion was organized in Mumbai's KEM on Clinical Research in India. Currently even though India has 16 percent of the world's population and 20 percent of the global disease burden, yet, less than 2 percent of global trials take place in India. Recently, the clinical trial industry has been in the eye of the storm due to dubious practices adopted by a few organizations. This has led to a strong call for transparency in carrying out clinical trials in the country. Originally hailed as a fast growing sector, the CRO industry has faced setbacks due to delays in approvals. The Indian Society for Clinical Research (ISCR) plans to commemorate International Clinical Trials Day with the theme, "Research Made The Difference" to highlight the positive difference that clinical research has made to a cross section of stakeholders, most importantly patients who have benefitted from newer and better medicines. Clinical trials have progressed considerably since Dr Lind's experiment. In 1863, placebos were first used in a clinical trial and in 1923, the concept of randomisation was introduced. The first trial using appropriately randomised treatment and control groups was carried out in 1948 by the Medical Research Council, and involved the use of streptomycin to treat pulmonary tuberculosis. This trial also featured blind assessment (where neither the researchers nor the patients knew which treatment group each patient was in at the time of the study) enabling unbiased analysis of the results. In India, the management of clinical trial data has supported growth of the Indian IT/KPO sector. Positive spin offs in allied disciplines leading to expansion of special labs devoted to clinical trials and development of clinical trial packaging and distribution industry. Clinical research has become an attractive new discipline and created job opportunities. Today, we have a large and growing number of trained clinical research professionals - research physicians, regulatory and ethics experts, study managers, monitors, quality assurance and pharmacovigilance experts, data managers, biostatisticians, and medical writers.   ]]> https://biospectrumindia.com/news/97/8118/agilent-introduces-verified-dissolution-components.html https://biospectrumindia.com/news/97/8118/agilent-introduces-verified-dissolution-components.html Mon, 20 May 2013 13:58:00 +0530 Agilent Technologies on May 20, 2013, introduced a new series of verified dissolution components, including molded vessels as well as paddle and basket shafts. Designed to ensure compliance with mechanical qualification guidelines, these components will be available from June 1, 2013 and offer verification that they conform to exact specifications. Dissolution is a technique used in the pharmaceutical industry to determine the rate at which pure active pharmaceutical ingredients dissolve. To meet precise tolerances, the new molded vessels are vacuum-formed around a set of Agilent's mandrils, which eliminates the warps and flaws of traditional hand-blown manufacturing. "To better support the qualification needs of our customers, it was critical for Agilent to offer improved options for component verification and traceability," said Mr Allan Little, director of marketing for dissolution systems at Agilent. "Not only do we offer these new vessels and shafts, but Agilent is leading the effort to educate pharmaceutical analysts on the importance of compliance with the developing qualification guidelines." The verified paddle and basket shafts are being introduced to meet a growing demand for verified components. Made with updated manufacturing processes, these shafts are measured to exact specifications and certified for traceability with an individual certificate of conformance. Qualification of dissolution apparatus in pharmaceutical laboratories involves performance verification testing, enhanced mechanical qualification, or a combination of the two procedures. With evolving guidance on qualification best practices, the adoption of verified components assists with long-term traceability and offers assurance that components meet tolerances set by the United States Pharmacopeia. ]]> https://biospectrumindia.com/news/97/8016/ge-enters-into-pact-with-maharashtra-government-for-upgrading-healthcare.html https://biospectrumindia.com/news/97/8016/ge-enters-into-pact-with-maharashtra-government-for-upgrading-healthcare.html Fri, 17 May 2013 17:49:00 +0530 In a consortium which includes the public health department of the government of Maharashtra, Wipro GE Healthcare and Ensocare by Enso Group, a public private partnership project will advance healthcare in the state of Maharashtra for setting up advanced diagnostic facilities at 22 government district and women hospitals. It will operate on a 24/7 hour basis and provide services at government recommended rate cards for the benefit of the broader population. Orange and Yellow 'Below Poverty Line' (BPL) card holders will be entitled to receive free diagnostic services under the Rajiv Gandhi Jeevandayee Arogya Yojana (RGJAY) scheme at all the 22 facilities which are expected to be operational within a year. Speaking on the occasion, Mr Prithviraj Chavan, Chief Minister, Government of Maharashtra said, "Today, we are on to a first-of-its-kind, large scale modernization of district hospitals with latest diagnostic technologies. No single agency can transform the entire healthcare system in the country but by working together with partners like GE and Ensocare, we can take a giant leap in advancing health care to people at all levels in society." The PPP agreement with Government of Maharashtra is the largest in terms of scale and includes the installation of four units of 64 slice CT scanners, 13 units of advance 16 slice CT scanners, eight units of cutting- edge 1.5T Magnetic Resonance Imaging systems, 22 high-end digital radiography systems, 39 color Doppler's and 39 analog X-ray units. These advanced world-class imaging systems will allow district hospitals provide early and accurate diagnosis on a 24/7 basis in the clinical specialty areas of neurology, cardiology, vascular imaging, emergency/trauma, oncology, obstetrics and gynaecology, orthopedics, gastroenterology, in addition to providing general purpose radiology. Also, women's health is given a special boost with the inclusion of 20 screening mammography units for early breast cancer detection. John Rice, vice chairman, GE said, "Providing high quality, accessible and affordable healthcare is one of the biggest challenges faced by governments all over the world. We are delighted to playing our part towards a healthier India and in helping to bridge the healthcare disparity." Commenting on the new partnership, Mr Banmali Agrawala, president and CEO GE South Asia said, "This PPP is the second partnership that we have forged with Maharashtra, the first being GE's setting up of its advanced multi-modal manufacturing plant at Chakan near Pune that we announced last June. This is testament in the progressive development of the state that we believe in the long run will be both economically and socially beneficial to people who live here. We look forward to more partnership opportunities in the future."   38 district and other large hospitals under Government of Maharashtra cater to about 100 million people. It is estimated that in a year, these hospitals carry out 100,000 CT scans, 50,000 MRIs, 300,000 color Doppler studies, 900,000 X-rays and 40,000 mammography exams for early detection and treatment of diseases. In the absence of quality diagnostic imaging equipment, patients are frequently, referred to private centers which substantially increases the cost of treatment. With this, GE Healthcare becomes the first company in India to design a PPP model to deliver quality imaging services comparable to super specialty units in government hospitals. Since the first project with Netaji Subhash Chandra Bose Medical College in Jabalpur in 2007, GE has successfully executed PPP projects spanning four states in India benefitting approximately 500,000 poor and needy patients. ]]> https://biospectrumindia.com/news/97/6760/we-are-a-niche-protein-research-services-company-dr-kundu.html https://biospectrumindia.com/news/97/6760/we-are-a-niche-protein-research-services-company-dr-kundu.html Fri, 17 May 2013 15:44:00 +0530 "The global CRAMS scenario has been very competitive, complex and cyclical. We are dependent on the success of the molecule moving from research to process development and then preclinical development," says Dr Prabuddha Kundu, executive director, Premas Biotech. "Any product related or efficacy related issues of the molecule usually results in the dropping of the discovery program, which then has a domino effect on us, who are dependent on that molecule moving ahead. So, Premas has a robust pipeline of the possible projects that we are handling." Established in 2005, the Manesar (Haryana) based Premas Biotech is a 100 percent Foreign Direct Investment (FDI) Contract Research And Manufacturing Services (CRAMS) organization. The uniqueness of the company within this vertical of research outsourcing is that it specializes in protein analysis and manufacturing. Over the period of time, the company has integrated thorough scientific analysis along with process know-how to accomplish its delivery of services to the customer. Company with the difference On being asked what makes them unique in the business, Dr Kundu says, "Delivery of services does not finish with the protein, but includes the Premas experience, that a customer undergoes which includes, customer engagement, project management, understanding customer goals and a keen eye constantly on product quality." Giving an example, Dr Kundu goes on to add, "Premas has an internal protein expression analysis software, that is proprietary to us, and has been able to generate a lot of buzz amongst our customers. It is a very interesting scope enabling piece of analytical software. The software predicts the difficulty of the protein being expressed, issues related to structure-function, and species for expression. It is back-ended to our database of proteins delivered, and we have a high rate of prediction success. Earlier last year, a company based in East Coast, the US, challenged the prediction ability of the software, and gave us a number of sequences, whose result, they knew, and we were 100 percent correct in predicting which ones would be difficult and which ones would be easier on a relative scale. But I would be cautious in extending this logic to all proteins, but these are ways we have made the Premas experience for our customers a satisfying one."   Premas has worked with the Open Source Drug Discovery (OSDD) program of Council for Scientific and Industrial Research (CSIR) amongst others. The company has also aided in the food security program of Government of India, by delivering three proteins which were technically challenging. "Presently, we have research assignments with the Top 5 pharma companies of the world. We have delivered over 230 proteins, and this year alone, we have delivered close to 200 grams of cumulative purified protein delivery, which is a significant number. So, taking this into perspective, we are a niche protein research services company, very focussed, and customer oriented," reveals Dr Kundu. Growth momentum gains pace As per Dr Kundu, the company posted some impressive numbers over the past two years, growing steadily. However, he feels that for a niche company like his, the more important parameter of progress is how many large pharma customers he engages and how much preclinical material, he is able to ship out. In this two areas, we have done fairly well. "I will not name my customers, but safe to say, we have 3 of the Top 10 global pharma companies working with us, we are developing rMAbs for another very large global pharma. In the Agbio arena, one of the largest companies are working with us and we have delivered about 130 grams of protein for toxicity and safety studies. So, overall, despite the recession, Premas over the past year has been able to engage global pharma companies with our focussed deliveries," he adds. Entrepreneurial blues   Dr Kundu feels that the entrepreneurship is difficult and challenging in any sphere of work. Being a niche company in bioresearch is of course challenging enough, but this is the journey that he decided to undertake, and hence he says it is satisfying in itself. Talking about the challenges, he says, "Some of the challenges that we face are fairly generic for any upcoming company such as recognition, acceptance in the market, meeting customer expectations, route to market, and new technologies to adapt. In the more specific areas, the challenges would be manpower availability, access to key-opinion leaders, biotech ecosystem, and access to risk funding. However, as we continue to grow, some of these challenges recede and others come up." Good growth expected According to Dr Kundu, Premas has invested deep into difficult to express protein platforms and know-how. This has had its positive effects on biobetters as well as biosimilars, though its primary focus is on enabling customers with their novel molecules. "We are now working on a few novel molecules, including one novel fab molecule for oncology application for a Europe-based customer. So, our focus is going to protein deliveries related to gene-preIND molecule expression, scale up, development of analytical methods, and delivery of sterile drug substances. Also, we have a parallel focus on agribiotech protein delivery systems. We have had fairly good success on some agbio proteins. As such, we cater to four application areas of drug discovery, agribio, animal health and reagent generation," he says. Talking about the outlook of the sector, Dr Kundu says, "There has been significant growth in the CRAMS arena with a number of players entering the arena, however in the protein segments, it is still an area of high capital investments and difficult technical barriers. Once, access to funding and protein expression platforms are there, then we will see a number of players enter the protein segments as well. We do see double-digit growth over the next five years." ]]> https://biospectrumindia.com/news/97/3267/qua-launches-electrodeionization-range-for-pharma.html https://biospectrumindia.com/news/97/3267/qua-launches-electrodeionization-range-for-pharma.html Mon, 13 May 2013 16:10:00 +0530 QUA, a leading developer of advanced membrane products for water and wastewater treatment applications, has launched FEDI-Rx Fractional Electrodeionization product range specially designed for applications in pharmaceutical, biomedical and laboratory applications where installations require hot water sanitization to meet pharmacopoeia standards for Purified Water (PW) and Water For Injection (WFI). Mr VJ Nathan, technical director, QUA Group, said that, "After successful acceptance of our industrial range of FEDI, we are now ready to service the pharma, medical, biomedical, cosmetics and laboratory arena with our innovative product range branded as FEDI-Rx. We are confident that our patented process of manufacturing ion exchange media will provide improved reliability of performance in these applications." In a short span of two years, the QUA Group's FEDI has more than 25 global installations including various sites in US, Europe and India. The company recently received the 2013 Frost & Sullivan New Product Innovation Award for Industrial Water and Wastewater Treatment Technology, North America, for FEDI electrodeionization and its Q-SEP hollow fiber ultrafiltration modules. Company officials state that India is an important market for the FEDI-Rx fractional electrodeionization product range. With patented dual voltage technology, QUA's FEDI technology is the next generation of electrodeionization (EDI) technology for the production of high purity water. Developed taking into account the limitations of conventional EDI, the FEDI process improves the reliability of EDI for the production of high purity water. QUA develops, manufactures and markets advanced membrane products to treat challenging waters. Headquartered in the US, the company also operates facilities in Europe and India. ]]> https://biospectrumindia.com/interviews/97/4260/a-one-stop-shop-for-customers.html https://biospectrumindia.com/interviews/97/4260/a-one-stop-shop-for-customers.html Thu, 09 May 2013 12:01:00 +0530 As a part of Thermo Fisher Scientific, Fisher Scientific has been a channel partner for not just the parent company's products, but also for other principals in the biosupplier domain having a revenue share of 20 percent in the entire group. Mr Amit Agarwal worked with Thermo Fisher Scientific group for 15 years in the US, before taking over as vice president and country head for Fisher Scientific India last year. Q: How would you describe Fisher Scientific' offerings in the Indian market?Mr Amit Agarwal: About seven years back, we bought a business called Qualigen, from GlaxoSmithKline, and that's how Fisher Scientific came into being. It was a primarily a chemicals company. Using that as a platform, we tried to reach out to different verticals that we focus on pharmaceuticals, life sciences, biotechnology, government and academic labs, over a period of time to the same customers. Since we are a part of Thermo Fisher Scientific, we sell their products along with those of other brands like Corning, LabConco, BD, and IKA. We also have a small healthcare business that is focusing on healthcare products for small labs. Additionally, we cater to industrial manufacturing units in food and agriculture, but that is not our focus area. Q: What verticals does this include?It includes instruments, chemicals, reagents, glassware, and consumables. Basically, we supply all the things present in a research laboratory. Globally, Fisher Scientific is known as "one stop shop" for everything a researcher would need. In terms of government and private, 25 percent is driven by government funding and the rest is from private sources. Small, medium big biotechs, pharma companies, private hospitals and pathology labs come in the latter class. Q: How does Fisher Scientific align its activities with Thermo Fisher Scientific's operations, while supplying other brands?Thermo Fisher is the parent corporation that includes Thermo Scientific, Fisher Scientific and Unity Lab Services, that is not introduced in India as yet, and smaller brands like Cole-Parmer, Nunc and Nalgene. Every product that we make is branded as Thermo Scientific. These products are then taken to the market through the channel, that is us. We do not deal with R&D and manufacturing, but are just the channel that sells internal products along with other brands. Our value proposition is choice and convenience. We would like the customer to first consider the Thermo Scientific product, but in case they would prefer some other brand, we would offer that product as well. Retaining the customer and building a relationship is important to us. We are selling other things over a period of time as well, so we offer them products as per their needs.   Q: Do you see any particular trend in the supplier industry?Over the last couple of years, sales of equipment and instruments has slowed down. What we are seeing is that, consumables in life sciences and biotech products, is showing a healthy growth. From a segment perspective, despite the economic slowdown, the pharmaceutical and life science segment is growing at 8-10 percent and is pretty strong. Its a mixed bag, some products are seeing the impact of the slowdown, whereas others are growing strong. Q: What is your outlook for the next year?There is a hope that things will improve, with the 12th Five Year Plan and its allocations for the life science industries. We haven't seen it yet. But we expect that may be in the latter half of 2013, government grants would start coming in and things will change. The depreciation of rupee was a big concern about six months back, but that issue is no longer there. Profitability has not been a major concern, but rather the major concern has been slowdown for demand of capital equipment in life sciences. I think that the first half of this year should be better than the latter half of last year and things would improve even more down the line. Q: What are the challenges that you face?There are two things. One is infrastructure. When we want to ship out products to customers, I have observed that the capability that service providers have in the US is lacking in India, partly because of the infrastructure issues in India. The other is again tied to the infrastructure issue, that it is difficult to reach out to customers in remote areas. Once you get into tier 2 and tier 3 cities, it starts getting tough, and you need to rely on distributors. Sometimes customers want to deal directly with the company; in situations like that, it gets challenging. We are now trying to improve our existing supply chain setups as well. Q: What kind of pattern have you seen with tier 2 and tier 3 cities?Things are definitely picking up in this regard. There is more focus on development of such cities, and part of it is engaged in developing research institutes in smaller places and towns. Also a lot of pharmaceutical plants are now opening in smaller cities, which offer more space and tax breaks. The customers are moving to these locations. For us to grow, we have to have a focus on tier 2 and tier3 cities as well. Q: What do you think differentiates Fisher Scientific from other competitors in the market?I think it all boils down to the fact that we are a one stop shop. Its not just different types of products but also different brands. We make it very easy for the customer to work with us. In one purchase order, a customer can buy everything , which dramatically improves the way we can transact and all of it can come in one shipment. And this is our value proposition across the globe. Speaking of the entire group, there is no other company that has more self manufactured products and distribution channels.   Q: How would you describe the company in terms of revenue?In terms of revenue, we would be roughly 20 percent in terms of revenue and people in India. Globally it is about a third of Thermo Fisher Scientific in terms of revenues. We should be be able to come up to the global standards soon. The average growth rate is 15-20 percent over that last few years. Q: What are the plans for Unity Lab Services?We have plans to introduce Unity Lab Services soon in India too. We are focusing on putting together a service portfolio in India. We have the capability and we are trying to build on it. Some of these services we have already been offering to customers in India, just not under this particular brand name. We are trying to put it all together. That may happen this or next year. ]]> https://biospectrumindia.com/news/97/4846/3m-launches-avagard-surgical-scrub.html https://biospectrumindia.com/news/97/4846/3m-launches-avagard-surgical-scrub.html Thu, 02 May 2013 15:42:00 +0530 3M recently announced the launch of Avagard, considered the world's first and only FDA, NDA approved waterless surgical scrub. It contains 1 percent chlorhexidine gluconate and 61 percent W/W Ethyl alcohol. 3M has used chlorhexidine in the combination for Avagard as it is a superior antiseptic compared to betadine. Another significant feature of Avagard is that it contains moisturizing cream which protects the skin from dryness resulting from repeated scrubbing. Avagard is a dry surgical scrub which does not require water, unlike conventional handscrubs which involve continuous flow of water for 3-5 minutes. ]]> https://biospectrumindia.com/news/97/4407/cole-parmer-launches-single-channel-flame-photometer.html https://biospectrumindia.com/news/97/4407/cole-parmer-launches-single-channel-flame-photometer.html Wed, 24 Apr 2013 16:48:00 +0530 Cole-Parmer recently launched an affordable option in flame photometers-the single channel, analogue output, and digital display flame photometer.It is an an economical, easy-to-use unit that determines the concentration of five elements. Five filters for sodium, potassium, lithium, calcium, and barium are included with the unit as a standard feature. Inheriting the mixing chamber, burner stem, and burner head from a higher-cost design, this unit offers the best limits of detection available from a low-cost instrument. The Cole-Parmer single-channel flame photometer is ergonomically designed with a front-loading, unobstructed sample work area with removable spill containment tray. The filter can be selected for the element to be analyzed using the filter stick. The front panel LED indicates the element tested as well as flame status. Next by pressing "hold" readings can be captured .Also auto ignition and flame optimization deliver ease of use. With a small footprint (approx. 20 x 30 cm), the unit takes up minimal space on the lab bench. It can be easily cleaned and maintained without the requirement of tools. Cole-Parmer has been a leading global source of laboratory and industrial fluid handling products, instrumentation, equipment, and supplies. They have expertise in the fields of temperature measurement and control, electrochemistry, and fluid handling. Their products are sold throughout the world through company-owned customer channel outlets and a strong network of international dealers. ]]> https://biospectrumindia.com/news/97/5576/it-is-the-age-of-digital-patient-says-quintiles.html https://biospectrumindia.com/news/97/5576/it-is-the-age-of-digital-patient-says-quintiles.html Tue, 23 Apr 2013 16:33:00 +0530 A new report by Quintiles has indicated that sponsor companies that can successfully engage with the digital patient will distinguish themselves and increase their probability of success. The report titled, 'Harnessing the Power of the Digital Patient' explores a more modern approach to patient engagement to streamline product development, prove product value and accelerate product adoption and adherence.It suggests that harnessing the power of the digitally connected patient can not only help produce enormous amounts of savings in the health care system, but also improve patient outcomes. In the report, Quintiles tracks the evolution of patient engagement models over time and argues that the patient is at the center of today's model-a change from the more company-centric models of the past. Declaring this, "The Age of the Digital Patient," the report dismisses the value of "old-school" patient databases to find patients, and declares the 2.4 billion people with an internet connection as "today's database". "It's not a question of 'when' these capabilities will be available," says co-author Mr David Coman, senior vice president Quintiles communications, "it's a question of when the industry will give itself permission to make these approaches standard. We have been preparing for 'The Age of the Digital Patient' since 2007, and have the capabilities and experience to provide transformational change today." Core to the Quintiles Digital Patient model is the building of trusted relationships via patient communities, and the creation of opportunities for patients to engage in managing their own health. These programs range from introductions to clinical trials, enrollment in adherence programs, to virtual studies that include collection of patient reported outcomes, medical records, lab data and device diagnostics to prove a product's value or safety-all collected directly from patients without introducing site burden. Quintiles digital patient experience extends back to its creation of Mediguard.org in 2007 and ClinicalResearch.com in 2009, and its completion of more than 350 custom patient programs on behalf of sponsors in its Digital Patient Unit. To date, it manages relationships with more than three million clinically profiled patients across nearly every therapeutic area. An example of the promise the digital patient holds can be found in an observational research study in which Quintiles recruited 425 patients with Chronic Obstructive Pulmonary Disease (COPD) from its online patient community. The first digital patient was enrolled in the study in a mere six minutes with the last patient confirmed in only nine calendar days. A second example can be found in a 1,255-patient women's health study in which it developed a custom communication plan for each patient in order to reduce the number of patients that become lost to follow up or drop out of the study entirely. The customized communication program kept patient engagement high and resulted in a 59 percent increase in the retention rate for the duration of the study. ]]> https://biospectrumindia.com/news/97/3198/pall-partners-with-spinchrom-to-launch-blitz-.html https://biospectrumindia.com/news/97/3198/pall-partners-with-spinchrom-to-launch-blitz-.html Tue, 23 Apr 2013 16:16:00 +0530 Pall India has entered into an exclusive India distribution agreement with Spinchrom Life Sciences, a division of Spinco Biotech. Through the agreement, Spinchrom will become the exclusive distributor to market in India ForteBio's BLItz system, a revolutionary platform that uniquely enables scientists to conduct label-free analyses of proteins using small sample volumes easily and cost-efficiently at their laboratory bench. ForteBio is a division of Pall Life Sciences and a leading supplier of label-free technology that accelerates the development of biotherapeutic and pharmaceutical products. "Given the growing biosimilar and proteomic activity in India, scientists' ability to understand protein interactions is increasingly a key success factor. The BLItz technology offers great value by means of a very cost-effective, simple and fast technology platform," says Mr Sachin Indane, director, BioPharm, Pall India. "The BLItz platform will revolutionize the use of label-free protein analysis here by making it more accessible than ever to individual bench scientists and this will help to further advance biotherapeutic development in India." Historically, institutions have used label-free assays selectively and relegated them to their core laboratories due to their high complexity and expense. This practice creates bottlenecks in biotherapeutic research and development, as scientists may wait days or weeks to schedule their experiments and then hours or longer to obtain results. The BLItz system is small - taking up less surface area than a tablet personal computer - so it can fit easily in an individual scientist's workspace. It is simple to use and requires only four microliters of sample - 15 to 20 times less volume than needed for traditional, surface plasmon resonance (SPR)-based label-free assays or microplate-based ELISA assays. The BLItz system is designed for any researcher working with proteins, particularly those who analyze column fractions, monitor protein expression, perform reagent QC, identify mechanism of action and signaling and run protein engineering studies. Additionally, the BLItz system's Dip and Read assays utilize disposable, ready-to-use biosensors that uniquely provide results in seconds to minutes. The BLItz system utilizes the same Bio-Layer Interferometry (BLI) technology that powers ForteBio's flagship Octet instrumentation platform, which enables real-time kinetics, affinity and quantitation measurements in high-throughput applications, with unprecedented ease of use and cost-efficiency. Mr C Ravindranath, managing director, Spinco Group of Companies added, "We are excited about teaming with Pall. This partnership enables us to position the innovative BLItz label-free protein analysis technology as a complementary tool to our existing proteomics portfolio thereby offering customers comprehensive solutions for protein characterization and interaction studies." ]]> https://biospectrumindia.com/news/97/2994/eppendorf-india-celebrates-10th-anniversary.html https://biospectrumindia.com/news/97/2994/eppendorf-india-celebrates-10th-anniversary.html Thu, 18 Apr 2013 15:38:00 +0530 Eppendorf India, a leading life science company that develops and sells instruments, consumables, and services for liquid-, sample-, and cell handling in laboratories has completed 10 years of direct operation in India. The company noted that there are no special discounts in connection to anniversary celebrations and it will be launching new products time to time. Launched in the year 2003 in the month of April, what started as a small organization with 23 people, is now grown to a company with 135 employees, and revenue in excess of Rs 100 crore. Today it has branch offices in nine locations and satellite operations in various cities in order to reach customers nationwide. In the last 10 years, the company has achieved few milestones. Adding feather to its cap is the Pipette Calibration Centre in Chennai which received ISO 17025:2005 accreditation from National Accreditation Board for Testing and Calibration Laboratories (NABL). To cater to the needs of customers at their doorstep, the company has launched Pipette Calibration on Call (PCoC), a mobile pipette calibration facility. Take this opportunity to thank all the customers, distributors, suppliers, media and employees for their support during last 10 years, Mr V Sankaranarayanan, CEO, Eppendorf India, said, "We expect continued support in the years to come!" Eppendorf products are broadly used in academic and commercial research laboratories, e.g., in companies from the pharmaceutical and biotechnological as well as the chemical and food industries. They are also aimed at clinical and environmental analysis laboratories, forensics, and at industrial laboratories performing process analysis, production, and quality assurance. ]]> https://biospectrumindia.com/news/97/3207/sigma-aldrich-to-distribute-ges-whatman-products-in-india.html https://biospectrumindia.com/news/97/3207/sigma-aldrich-to-distribute-ges-whatman-products-in-india.html Wed, 17 Apr 2013 17:17:52 +0530 GE Healthcare, a global company that provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world has signed an agreement with Sigma-Aldrich to distribute its Whatman range of products in India. The Whatman range of innovative papers and filters includes sample collection and storage cards (FTA cards), filter papers, and specialist diagnostic membranes used in a wide range of applications such as forensics, neonatal screening, environmental screening, quality control of pharmaceuticals, food and beverage production and in the manufacture of in-vitro diagnostic tests. Many leading Indian companies and institutions use Whatman products for advancing their life sciences research and medical technology applications. The company noted that its Whatman FTA cards are widely used for collection, storage, transportation and purification of DNA as well as blood samples as it eliminates the need for expensive freezers and risk of transporting bottled blood samples. GE Healthcare Life Sciences provides expertise and tools for a wide range of applications, including basic research of cells and proteins, drug discovery research, as well as technologies for start-to-finish large-scale manufacturing of biopharmaceuticals. The company has been steadily increasing its footprint in India through the establishment of an R&D center, Fast Trak BioPharma Services to support the rapidly growing biopharmaceutical industry in India, and a customer training and education center in Bangalore. Mr Anurag Gupta, Managing Director, GE Healthcare Life Sciences South Asia, said,"This distribution agreement with Sigma Aldrich will allow GE Healthcare to bring its innovative Whatman products to a much wider range of customers in a variety of academic and industry settings across India." Mr. Raja Ram, Managing Director, Sigma-Aldrich, India said, "Continuing to deliver on our mission of enabling science to improve the quality of life, we are excited at the partnership we have forged with GE Healthcare Life Sciences to distribute Whatman products. The partnership will enable customers to benefit from Sigma-Aldrich's established standards of service and operational excellence within India." ]]> https://biospectrumindia.com/news/97/5568/thermo-fisher-acquires-life-technologies-for-13-6-billion.html https://biospectrumindia.com/news/97/5568/thermo-fisher-acquires-life-technologies-for-13-6-billion.html Tue, 16 Apr 2013 12:57:00 +0530 Thermo Fisher Scientific and Life Technologies Corporation have signed a definitive agreement under which Thermo Fisher will acquire Life Technologies for $13.6 billion, plus the assumption of net debt at close ($2.2 billion as of year end 2012). A statement from both the companies has said that this acquisition will strengthen technology and innovation leadership through complementary offerings that broaden Thermo Fisher's industry-leading portfolio.The combined company will also build on its strong foothold in Asia-Pacific, particularly in China, to meet increasing customer demand in life sciences and healthcare. The combination will build on both companies' technological strengths to accelerate results for life sciences customers working in proteomics, genomics and cell biology. "We are extremely excited about this transaction because it creates the ultimate partner for our customers and significant value for our shareholders," said Mr Marc N Casper, president and chief executive officer of Thermo Fisher Scientific. "The acquisition of Life Technologies enhances all three elements of our growth strategy: technological innovation, a unique customer value proposition and expansion in emerging markets. He added, "Our customers in research and applied markets will now be able to achieve even higher levels of innovation and productivity by working with the combined company. We're especially excited about the new opportunities we will have to leverage our complementary offerings, fueled by a shared commitment to continuous innovation." Mr Gregory T Lucier, chairman and chief executive officer of Life Technologies, said, "This transaction brings together two companies intent on accelerating innovation for our customers and achieving greater success in a highly competitive global industry. Further, this combination delivers immediate and significant cash value to our stockholders and represents a successful conclusion to the board's strategic review to enhance stockholder value and develop an even stronger future for Life Technologies."   Life's leading technologies are protected by approximately 5,000 patents and licenses, and it builds on this position through a strong commitment to innovation. With 2012 revenues of $3.8 billion, its comprehensive offering includes a broad range of reagents, consumables, instruments and systems. It is well-known for its next-generation sequencing capability, and also has a range of technologies for bioproduction and forensics applications. These strengths, combined with Thermo Fisher's leading offerings in analytical technologies and specialty diagnostics, create new opportunities to support the convergence of life sciences tools and diagnostics.Life has an expansive commercial presence and global footprint as well, with more than 10,000 employees serving its customers around the world. It is expected that Life Technologies' president and chief operating officer, Mr Mark P Stevenson, will have a significant leadership role in the combined company. Thermo Fisher will acquire Life for $76.00 in cash per fully diluted common share. The transaction, which is expected to close early in 2014, is subject to a Life shareholder vote and satisfying customary closing conditions, including regulatory approvals. The acquisition of Life presents the opportunity for $275 million of adjusted operating income synergies in year three following the close, consisting of $250 million of cost synergies and $25 million of revenue synergies. In addition, Thermo Fisher expects the transaction to be significantly and immediately accretive to adjusted EPS. ]]> https://biospectrumindia.com/news/97/3222/university-of-dundee-licenses-gvk-bio-online-sar-database.html https://biospectrumindia.com/news/97/3222/university-of-dundee-licenses-gvk-bio-online-sar-database.html Wed, 10 Apr 2013 16:51:00 +0530 GVK Biosciences today announced that it has licensed its online SAR database - GOSTAR to the Drug Discovery Unit (DDU) at the University of Dundee. GOSTAR, a manually curated database, has been developed over the span of a decade by a team comprising of more than 200 curators. The product issued globally in various areas such as pharmaceuticals, academics, government sectors, apart from numerous publications that cite the data contained in GOSTAR. GOSTAR contains over 6 million compounds manually curated through the screening of over 2 million patents and 400,000 journals and it also contains more than 18 million quantitative SAR points. GOSTAR is the final outcome after the integration of over fifteen individual databases, which includes the complete chemical space for ten of the popular biological targets. In addition to this, the MedChem Databases includes all published and patented inhibitors against biological targets that exceed 6,500 in number. In addition to this, GOSTAR also contains two databases on toxicity and natural products each. Several analysis tools have also been built into the product to enhance its performance. Sreeni Devidas, Vice President Business Development at GVK BIO said, "We are excited that the Drug Discovery Unit (DDU) at the University of Dundee has decided to license GOSTAR. This database will provide valuable information to the researchers at Drug Discovery Unit (DDU) and aid them in their drug discovery endeavors." Professor Ian Gilbert, DDU Head of Medicinal Chemistry and Acting Head of the Division of Biological Chemistry said, "The Dundee Drug Discovery Unit (DDU) is pleased to be able to license the GOSTAR database from GVK BIO. The DDU has the remit of developing translational research at Dundee and outside, by bringing together the Unit's experience of drug discovery in the pharma/biotech sector with basic academic research to identify new treatments for diseases. " He added that,"It is a rare fully operational and integrated drug discovery team within UK universities working across multiple disease areas, with the full range of disciplines required to produce novel hit and lead candidates. It is envisaged that the GOSTAR database will greatly impact the drug discovery efforts underway within the DDU" GVK Biosciences is one of Asia's leading Discovery Research and Development organization. It provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. GVK BIO's diverse portfolio and prestigious clientele comprising of more than 150 customers includes some of the world's largest pharmaceutical, biotechnology, agro, life-sciences companies and leading academic institutions. ]]> https://biospectrumindia.com/news/97/7511/ehealth-access-conducts-telemedicine-pilot-in-gujarat.html https://biospectrumindia.com/news/97/7511/ehealth-access-conducts-telemedicine-pilot-in-gujarat.html Wed, 10 Apr 2013 16:21:00 +0530 eHealth Access recently conducted a medical camp in the Dang district of Gujarat. The medical camp was a pilot test which offered free consultations with doctors via the recently launched Medical Kiosk by eHealth Access.The two day pilot started with Gujarat Dang district where 128 consultations (65 percent females and 35 percent males) were conducted successfully. Commenting on the event, Mr Suchindra, IFS officer from Dang district, Gujarat, said, "eHealth Access has developed a very useful model; The innovative Medical kiosk technology will help tribal villages to have effective primary and preventive healthcare and this has proved to be working." The Medical Kiosk developed by eHealth Access is a portable plug and play device that enhances the doctor reach by enabling new paths for doctor consultations to support patient with their primary health needs. Doctors can now reach the patients regardless of geographical boundaries through the Medical Kiosk. "This is a boon to rural India and can be a means to make Government of India's Universal Health Program a reality, where we can reduce the doctors to Patient gap and make "doctor-reach" a reality for the common and underserved population, thereby aiding in the process of making India Healthy." said, Mr Ram Prabhu, technology director, eHealth Access. "We started the pilot test in Gujarat and are planning replicate this activity PAN India." The latest census of health sector shows that India is lagging behind in doctor-patient ratio. It is observed, at present, that there is only one doctor available for more than 1,900 patients. Experts believe that in-order to reach an ideal doctor-patient ratio a standard, India has to wait till 2050.   The technology built in the Kiosk, allowed assessing patient's profile on BP, Sugar, ECG, temperature and BMI to be transferred to the doctor instantaneously, at the health camp. After the diagnosis, people got their respective prescriptions printed on the local printer. People also brought in their previous medical reports for second opinion and they were able to scan it in the Medical Kiosk to send it to the Doctor and could successfully get the doctor's response through video consultation. "I'm pleased with the technology in the device; it is almost like real time experience and makes it possible to see all of the patient vitals, patient over web, and investigation in electronic form," said Dr Rikin Patel, a medical practitioner from Gujarat who participated in the health camp. The free medical camp was supported by Working Brains who are distributors of the Medical Kiosk. ehealth Access is an innovative health care company, is focused on developing a new health care ecosystem through advanced telemedicine technology. The company through its website provides healthcare services over internet and through phone. ]]> https://biospectrumindia.com/news/97/3025/cisco-report-says-indian-public-open-to-virtual-healthcare.html https://biospectrumindia.com/news/97/3025/cisco-report-says-indian-public-open-to-virtual-healthcare.html Thu, 04 Apr 2013 14:00:28 +0530 A recent survey by Cisco has revealed that the Indian population is more receptive to using technology to review a a health condition rather than visiting the specialist in person.It revealed that nearly 88% of consumers would be comfortable communicating with a specialist using virtual technology (e.g. video chatting, text messaging). The Cisco Customer Experience Report focused on health care was   conducted in early 2013, and included responses from 1,547 consumers and HCDMs globally, with a consistent sample size of around 200 local respondents in each of the 10 countries surveyed.It also examined perceptions of consumers and health care decision makers (HCDMs) on patient experience in health care. The report also revealed that 86% of Indian consumers surveyed would be comfortable with submitting genetic information to a doctor or other health care professionals to ensure they have all information available to treat and offer the most personal diagnosis possible. This could prove to be very important in current times, as an increasing number of people decide to opt for getting their genetic information through services offered by young startups like Xcode Life Sciences, Genomepatri and more. The report findings challenged the assumption that face-to-face interaction is always the preferred health care experience. While consumers still depend heavily on in-person medical treatments, three- quarters of patients and citizens are comfortable with the use of technology for the clinician interaction.75% of global consumers indicate they are comfortable with the idea of communicating with doctors using technology instead of seeing them in person. Vishal Gupta, VP/general manager, Global Healthcare Solutions said, "Virtual healthcare is no longer a myth and this report is an indication of how technology can potentially play a greater role in enabling access to virtual healthcare. The state of convergence between the physical and digital world has raised the expectations of consumers and at the same time expanded scope for healthcare providers to take their engagement further with more collaboration and information." Interest in accessing health information on mobile devices is also growing rapidly and is the No. 1 topic of consumer interest in India, Mexico, Brazil and China. Nearly 30% of those surveyed in India confirmed using health and fitness or medical apps on their mobile devices. Rajendra Pratap Gupta, chairman, board of directors, Healthcare Information and Management Systems Society (HIMSS) Asia Pacific India Chapter commented "Healthcare IT is a pre-requisite for equitable healthcare. Patients are perennially intimidated and bogged down by their healthcare experiences. However, the accelerated growth of smart devices backed by an intelligent network will soon render these issues non-existent. This report is an indicator towards how customers and patients will be more empowered in future, with easy access to information, enabling them to be more involved in the process.   ]]> https://biospectrumindia.com/news/97/3895/sigma-aldrich-launches-vetec-brand-in-india-.html https://biospectrumindia.com/news/97/3895/sigma-aldrich-launches-vetec-brand-in-india-.html Thu, 04 Apr 2013 13:13:44 +0530 Sigma-Aldrich Corporation, a leading life science and high technology company has launched its new Vetec brand product line in India. The Vetec portfolio is aimed at meeting the everyday needs of scientists in India and is comprised of a growing collection of over 400 reliable-quality laboratory reagents, competitively priced to enable their use in routine research. Vetec, backed by Sigma-Aldrich's industry-leading quality and supply chain excellence, offers customers a strong alternative to the brands that currently serve India's "everyday" research market and includes solvents, buffers, carbohydrates, detergents, inorganic salts and synthetic reagents. The brand is aimed at providing reliable, easy-to-order, readily available products for everyday laboratory use. Supply chain aspects including quality testing, packaging and distribution of Vetec products are handled at the recently commissioned Sigma-Aldrich facilities in Bangalore and Mumbai in India, and Wuxi in China. "Sigma-Aldrich has been conducting business in India for more than 20 years. Our success will continue to be based upon our capabilities and the ability to customize our offer to meet the demands of the local market," said Mr Jason Apter, Vice President and Managing Director, Asia Pacific. "In October, 2012, the Vetec brand was introduced in China. Its launch in India, and subsequently into other countries in the Asia Pacific region supports our company's strategy of 'international localization'." According the company release, Vetec products are thoroughly tested to ensure they meet Sigma-Aldrich quality control standards for integrity, consistency and reliability and come with Certificates of Analysis, MSDS information and spec sheets. Vetec products are in stock and ready to order through the its website, through local sales representatives, or through the authorized distributor network. Other recent Sigma-Aldrich Asia Pacific initiatives include the substantial expansion of Global Shared Service (GSS) in Bangalore, India and a 20-acre campus in Wuxi, China, which is now fully operational. The company completed a new precursor manufacturing facility in Taiwan to support its SAFC Hitech business. ]]> https://biospectrumindia.com/news/97/8295/krishgen-biosystems-completes-a-decade-in-the-biotech-industry.html https://biospectrumindia.com/news/97/8295/krishgen-biosystems-completes-a-decade-in-the-biotech-industry.html Fri, 29 Mar 2013 15:34:00 +0530 This March, Krishgen Biosystems would be finishing its 10th year of operations. What sets it apart from other companies in the biosupplier domain is that its led by a woman, Ms.Neelam Jain who is the CEO. There are only a handful of life science companies that are led by women in India, with many successful entrepreneurs becoming the face of Indian biotech not only in India, but also internationally. Krishgen is a leading provider of tools such as molecular biology reagents, immunoassays, media, toxicology screening reagents and more for diagnostics and research. Their USP, they say is to manufacture, market and sell much needed quality materials to the life sciences industry with the help of partnerships with various companies,at Indian prices. A graduate in commerce from Indore's MKHS college Ms.Jain says, that growing up in a business family, she got the opportunity to get up, close and personal with real time case studies on management. In March 2003,exactly ten years ago, she took the plunge into entrepreneurship and started Krishgen to address the unmet needs of the life sciences market. The fact that she is a woman entrepreneur has also led her to align to Krishgen's focus on solutions for women."Woman health issues are close to my heart especially breast cancer. I have been pushing my team to work on offering quality diagnostic 'non-intervention' tests and preventive care solutions. We have recently launched a test kit for monitoring dosage of Trastuzumab for patients to be used by clinicians. Trastuzumab is a Her2+ breast cancer therapy designed to treat aggressive HER positive metastatic and adjuvant breast cancer." On maintaining a home-work balance, she adds, "To be a successful career woman, implicitly requires family support. I have immense belief in the fact that woman are better business woman due to the inherent fact that they are better multitaskers." However challenges remain, "I feel guilty at times, that I have not been able to give enough time to my family. But the satisfaction of doing something which is your own surpasses all the difficulties and pressures you face." ]]> https://biospectrumindia.com/news/97/4913/sartorius-stedim-launches-single-use-clipsters-.html https://biospectrumindia.com/news/97/4913/sartorius-stedim-launches-single-use-clipsters-.html Wed, 27 Mar 2013 14:19:00 +0530 Sartorius Stedim Biotech, a leading international supplier for the pharma and biotech industries, has launched new sizes XS and S of the Clipster Aseptic Disconnector, in addition to the existing size L. This single-use device allows an aseptic disconnection of Silicone (Pt) as well as thermoplastic elastomer (TPE) tubes in biopharmaceutical manufacturing processes. It is safe, quick, easy to use and available as a stand-alone product or pre-mounted on single-use transfer lines and bag assemblies. The Clipster Aseptic Disconnector is used after a fluid transfer to disconnect transfer lines and bag assemblies. The disconnection of tubes can be performed in non-classified and classified environments while maintaining product sterility. It is performed with a hand-held tool which ensures easy execution in various space requirements. The Clipster Aseptic Disconnector XS, S or L can be applied to multiple tubing material (silicone and TPE) and sizes from 1/8"x1/4" up to 1/2" x 3/4". The validation of this key single-use device has been carried out under the most stringent test regimes. Biological and physical tests have been combined to provide data representing a variety of process conditions including critical applications. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of "turning science into solutions". ]]> https://biospectrumindia.com/interviews/97/7691/cloud-computing-is-gaining-prominence-in-life-sciences-industry.html https://biospectrumindia.com/interviews/97/7691/cloud-computing-is-gaining-prominence-in-life-sciences-industry.html Tue, 26 Mar 2013 16:49:00 +0530 Known as one of the leading software services companies in India, few are aware that the healthcare and life sciences industry segments actually contribute upto 26.3 percent of Cognizant's revenues. Cognizant offers a number of services in the domain of pharmacovigilance, supply chain management and solutions for drug discovery. Cognizant was recently adjudged the leader in the recent IDC MarketScape evaluation of drug safety services providers in the life science industry. Q: How important are the operations for the pharma/life sciences industry at Cognizant? We are a leading service provider to the life sciences industry, working with 27 of the top 30 global bio-pharmaceutical companies, nine of the top ten biotech companies, and three of the top 10 global medical devices companies. Our comprehensive and diverse solution offerings address the needs of the customers across the dimensions of plan, build and operate through our consulting, BPO, ITO and IT IS services. In 2012, the healthcare and life sciences industry segments together contributed 26.3 percent of Cognizant's revenues. Q: Can you talk about Cognizant's work vis-a-vis Indian clients? What services do you provide to the Indian pharma industry? We have increased our focus on the India market in the recent years and are working with quite a few leading companies. We are seeing a strong focus on benchmarking processes, standards and adherence to constantly changing regulatory demands. This has created several consulting opportunities where we have been able to streamline processes, benchmark to standards and provide an IT roadmap. Some of the popular demand areas are QC systems (such as Laboratory Information Management System), SAP (Enterprise Resource Planning),Product Lifecycle Management (PLM), Manufacturing Execution Systems (MES), safety and regulatory operations and commercial operations. Q: Could you also elaborate on how cloud computing is being used in the pharma and life sciences segment? Cloud computing is gaining a lot of prominence in the life sciences industry segment. Within R&D, discovery and translational medicine are some of the key areas which are driving demand. Next Generation Sequencing (NGS) is obviously a key application area that requires both storage and compute resources. Other areas such as molecular modeling and predictive modeling are also being moved to the cloud. Translational medicine is another area which, given its multidisciplinary nature, is adopting cloud, again for both storage and compute. One of the leading industry initiatives for translational medicine, tranSMART is on the Amazon cloud. Security continues to be the top concern for adoption of public clouds, but there are several instances of private cloud for addressing the needs of the life sciences segment. With cost pressures and the need to reduce capital expenses, cloud adoption is gaining momentum across the life sciences value chain and is not limited to R&D functions such as sales force automation, sales effectiveness services, brand management and analytics, and so on.   Q: What is the Pistoia Alliance and could you elaborate a bit about your work for it? Cognizant has delivered a conceptual cloud-based platform as part of the Pistoia Alliance to facilitate access to public and proprietary sources of gene sequence data. The Pistoia Alliance's sequence services working group aims to define and document an externally hosted service for securely storing and mining both proprietary derived gene/sequence information and public domain genomics/genetics databases. This platform developed by Cognizant enables working group companies to securely share their bioinformatics resources among simultaneous, registered users in a secure, encrypted environment, while leveraging the flexibility, scalability, and cost-efficiencies of a cloud-based Software-as-a-Service (SaaS) platform. Cognizant has leveraged its domain-intensive global resources, deep understanding of drug development processes and cloud computing models, and global program management and delivery capabilities to build and manage a platform that supports the Pistoia Alliance's aim to lower barriers to innovation by improving the interoperability of business processes, data, and technology interfaces in the life sciences research industry. Q: Can you give any case examples of how solutions for discovery and preclinical studies have been used? Discovery usually comprises several disparate and small systems that grow both organically and inorganically adding to both license costs and maintenance overheads. Cognizant's solution offering for discovery and preclinical studies covers the breadth of consulting, development and support spectrum. Portfolio rationalization helps consolidate both the processes and the tools. In the area of preclinical studies, we have worked with our customers across process harmonization and product selection for areas such as animal welfare management system. One of our core solution offerings is implementation of Electronic Laboratory Notebooks (ELN), Laboratory Information Management Systems (LIMS), Chromatography Data Management Systems (CDS) and Scientific Data Management Systems (SDMS). We have serviced several customers in ELN and LIMS implementations, and have also developed several solutions ground up in areas such as compound management, reagent management, preclinical data warehouse, and so on. Our "SEND in a Box" solution was launched recently to address the upcoming FDA mandate for submitting non-clinical data in the CDISC SEND format. SEND is similar to SDTM for submitting clinical data. We support several customers in managing and maintaining their lab and discovery portfolio of applications. This is a managed service offering and outcome-based. In addition, we have also mobile-enabled some of the key use cases within a lab by integrating with a LIMS application. We now have a strong focus on translational research and are working with our customers to understand and define their strategy since these are still early days.   Product development, manufacturing and supply chain are key elements of Cognizant's Life Sciences portfolio. Through these areas, we cover the entire technical operations space, including quality, compliance and CMC regulatory compliance. Q: Do you see any trends in the pharmacovigilance segment in the last year? We see an increasing trend in partnering on the end-to-end process of pharmacovigilance. Several activities considered core earlier are currently being outsourced, including activities such as signal detection and aggregate reporting. We see a trend where companies are engaging in strategic consulting and looking to transform benefit risk management of their safety operations. This clearly follows the earlier trend that started with outsourcing medical contact center, followed by case management operation. We are also seeing the impact of Social, Mobility, Analytics and Cloud (SMAC) on safety. Delivery models are evolving to leverage the cloud and moving towards the "as-a-service" model, specifically business process-as-a-service. Considering the growing interest in tracking and reporting adverse events from social media, we have made significant investments around safety transformation and tools for automating aggregate reporting and social media tracking and reporting of adverse events. Q: Have you introduced any new services in the recent past, keeping in mind any market trends such as Quality by Design requirements by FDA, or specifically for biosimilars/vaccines? We constantly add new services to proactively address any market trend or regulatory requirement/ change. The solution portfolio outlined earlier is a mix of established and new services. Solutions that enable robust product development and help achieve operational excellence by enabling automation and improving compliance are established service offerings. Those aimed at building an advanced planning framework, and transforming distribution network by using a service-based approach are relatively new offerings, responding specifically to serialization and pedigree demand, and planning and cost optimization respectively. ]]> https://biospectrumindia.com/news/97/8239/lambda-theraputic-organizes-meet-for-clinical-trial-professionals.html https://biospectrumindia.com/news/97/8239/lambda-theraputic-organizes-meet-for-clinical-trial-professionals.html Fri, 22 Mar 2013 16:01:00 +0530 Lambda Therapeutic Research successfully conducted a symposium on "Innovation in Clinical Trials" on the 15th and 16th of March, 2013 at Ahmedabad. Around 50 delegates from different pharmaceutical & biotechnology organisations across India participated in this two-day symposium, which was inaugurated by Dr. H.G. Koshiya , Commissioner, Food & Drug Control Administration, Government of Gujarat and Dr. Ramkishan (ADC), CDSCO, zonal office, Ahmedabad. Lambda's initiative to organise such a knowledge sharing event were acknowledged and appreciated by all delegates. Renowned and eminent scientists from the Drug Development & Clinical Research arena assembled to discuss and explore new thoughts and learning to understand the ever changing dynamics of the industry. The current regulatory environment and the new regulations were discussed with the Commissioner, Food & Drug Control Administration - Gujarat and Assistant Drug Controller, CDSCO, Zonal Office - Ahmedabad, who also attended the symposium. Mr. Sanjeev Kaul (MD, Chrys Capital Advisors) and Mr. Sudarshan Jain (MD, Abbott Healthcare) were among the eminent speakers invited for the symposium. Topics like the latest challenges in Global Clinical Trials, Market Outlook for the Indian Clinical Trial Industry, Investment trends in Drug Discovery and Development, Current trends in Data Management in Clinical Trials, etc. and other topics straddling all the latest trends and updates in the industry were well received. The objective of conducting this symposium was met and knowledge in the arenas of innovation in drug development and clinical research was shared in the group. All the participants felt the need of conducting such symposiums in future and Lambda is determined to continue with this precedent established by holding such events on a more regular basis in the future. ]]> https://biospectrumindia.com/news/97/3139/cole-parmer-launches-special-tubing-for-biotech-applications.html https://biospectrumindia.com/news/97/3139/cole-parmer-launches-special-tubing-for-biotech-applications.html Fri, 22 Mar 2013 12:14:00 +0530 Cole-Parmer recently launched PharMed BPT tubing formulation, an ideal tubing for use in cell culture, tissue culture work,medical diagnostic product manufacturing, fermentation systems and purification applications. PharMed BPT is manufactured according to GMP, is FDA-compliant and meets USP Class VI, European Pharmacopoeia and NSF requirements.It can be used in clean-in-place (CIP) and steam-in-place (SIP) cleaning systems and can be sterilized by autoclave, ethylene oxide or gamma irradiation. This tubing is nontoxic nonhemolytic with extremely low permeability. It resists acids, alkalies, oxidizing agents, and animal and vegetable oils. PharMed BPT is heat-resealable, bondable and formable, making it ideal choice in bioreactors and single use applications. It is opaque beige in appearance and is useful in applications involving light-sensitive samples. It operates optimally in temperatures between -59°C to 135°C. PharMed BPT formulation is less permeable to gases and vapours than silicone tubing and has a superior flex life which reduces the production downtime when used in peristaltic pumps. ]]> https://biospectrumindia.com/news/97/3188/fisher-scientific-introduces-fisherbrand-centrifuge-tubes-and-serological-pipettes.html https://biospectrumindia.com/news/97/3188/fisher-scientific-introduces-fisherbrand-centrifuge-tubes-and-serological-pipettes.html Wed, 20 Mar 2013 17:26:39 +0530 Fisher Scientific, a part of Thermo Fisher Scientific India recently launched Fisherbrand centrifuge tubes and serological pipettes. The bransd are set to represent quality, consistency and reliability. By introducing these products in the life science portfolio, Fisher Scientific hopes to offer its customers "Convenience and Choice" to select from the existing premium brands like NUNC, Corning. The Fisherbrand centrifuge tubes and Serological Pipettes are Durable, chemical-resistant and clear polypropylene. Most styles and sizes are available in all the range in individually wrapped foam racks or in bulk packs. Fisher Scientific offers a product portfolio that spans chemicals, life science and general laboratory supplies from leading product and supplier brands. By combining global supply chain expertise with customized product and service solutions, they provide choice and to make order processing easy. ]]> https://biospectrumindia.com/news/97/7119/waters-releases-new-products-in-the-analytical-standards-and-reagents-portfolio.html https://biospectrumindia.com/news/97/7119/waters-releases-new-products-in-the-analytical-standards-and-reagents-portfolio.html Wed, 20 Mar 2013 15:34:40 +0530 Waters Corporation introduced Quality Control Reference Materials (QCRMs) and Certified Containers to the Analytical Standards and Reagents product group. Specifically designed for Waters instruments, QCRMs are the simplest and fastest way to understand a chromatography or MS system's health while ensuring repeatable performances. Waters Certified Containers for solvents and mobile phases are uniquely processed and treated to prevent extraneous peaks and baseline noise. The Waters QCRM portfolio is a collection of standards and mixtures specially formulated and based on the expertise of Waters scientists. QCRMs enable one to evaluate and benchmark their LC or MS system, ensuring repeatable performance each and every time. These ready-to-use standards are made in our ISO 9001, ISO 17025 accredited facility. QCRMs can be used for an impressive number of performance tests on instruments. They range from less complex neutrals mixtures to more complex application-specific standards. All compounds in the portfolio are vigorously evaluated and chosen because they are acceptable for use on a variety of columns with good peak shape in UV and MS. In addition, QCRMs assess hardware, software, mobile phase, column and chemistry issues. The new Certified Containers help ensure that our customers can produce dependable, consistent and high quality results as easily as possible. Certified Containers can be used on any LC system, including UPLC, LC/UV, and LC/MS. Manufactured to stringent standards, these unique containers prevent extraneous peaks and baseline noise stemming from high TOC, glass chemistry interference, and glass degradation due to glass matrix hydrolytic attack. “We added Analytical Standards and Reagents to Waters' competency because they improve the accuracy of measurements. QCRMs and Certified Containers are another significant and innovative step in that direction. By integrating these products, our customers can see improved data acceptance. Furthermore, by eliminating the need to mix and formulate standards and the unknown quality of mobile phase and solvent containers, our customers will have more time for scientific problem solving,â€? said Mike Yelle, Vice President, Consumable Business Unit. ]]> https://biospectrumindia.com/news/97/4436/bis-recognizes-schotts-expertise-in-pharma-glass-manufacturing-.html https://biospectrumindia.com/news/97/4436/bis-recognizes-schotts-expertise-in-pharma-glass-manufacturing-.html Tue, 19 Mar 2013 18:21:54 +0530 The international technology group, SCHOTT has been appointed to India's national standards body- Bureau of Indian Standards (BIS). As a new BIS member, the company will advise CHD-10, a subcommittee of the Chemicals Department, on specifications and guidelines for various kinds of glass manufacturing in India - mainly for pharmaceutical tubing but also for other applications such as fire-safe glass, household appliances, and fiber optics. This allows BIS to tap into SCHOTT's vast experience in the areas of specialty glasses, materials and advanced technologies. "It is a tremendous privilege to support BIS in improving glass manufacturing standards in India," says Sundeep Prabhu, Vice President Marketing and Sales for Pharmaceutical Tubing at SCHOTT Glass India. "This milestone is another illustration of the outstanding standardization of product quality and manufacturing processes SCHOTT has achieved in India. Together with BIS, our efforts will benefit Indian consumers as well as industry by ensuring that glass products are safe, reliable and of highest quality." BIS' decision underlines SCHOTT's position as a global leader in high quality glass manufacturing. Working closely with India's national standards body, SCHOTT will share its decades of expertise with the aim of enhancing production and testing standards of India's glass manufacturing industry. For more than 125 years, SCHOTT has constantly improved its quality standards to accommodate evolving market demands and deliver maximum benefits to its customers. A key global success factor for SCHOTT has been its strong focus on maintaining the highest quality standards. Company data released recently proves that SCHOTT managed to maintain stringent quality standards in the area of pharmaceutical tubing consistently over the last 25 years (1988-2013). "At SCHOTT, we have been setting standards for manufacturing glass tubing with our technical terms of supply. This means we are committed to constantly improve our production process and offer our customers the highest possible transparency and quality assurance," says Jürgen Achatz, Global Sales Director for Pharmaceutical Tubing at SCHOTT. SCHOTT offers pharmaceutical glass tubing products & services to customers world-wide from its five production sites in Europe, South America and Asia, including the one in Jambusar, Gujarat which serves the Asia region. ]]> https://biospectrumindia.com/news/97/3158/eppendorf-launches-new-detection-instruments.html https://biospectrumindia.com/news/97/3158/eppendorf-launches-new-detection-instruments.html Mon, 18 Mar 2013 15:36:00 +0530 Eppendorf, a leading life science company that develops and sells instruments, consumables, and services for liquid-, sample-, and cell handling in laboratories, has extended its detection product portfolio by launching BioSpectrometer fluorescence and the new BioPhotometer D30. According to industry reports detection instruments are available in the ragne of Rs 2 - 20 lakh. The new instruments offer additional measurement capabilities and features to the wide range of Eppendorf´s easy-to-use instruments that combine effective hardware with powerful and innovative software solutions. The detection instrument portfolio of Eppendorf is supported by accessories and consumables, such as the UVette, a UV-transparent disposable cuvette, and the new semi-micro and macro Vis Cuvettes. Additional accessories that include reference filter sets and a microvolume measurement cell, the µCuvette G1.0, to measure sample volumes of only 1.5µL, are available. According to Mr M. Anthoni Jai Kumar, Marketing Manager, Eppendorf India, " Our people will be directly handing the sales of these new instruments instead of distributors." The Eppendorf detection family is used in a broad range of life science applications, including kinetic and fluorescence measurements as well as microvolume measurements. The combination of Eppendorf instruments, accessories and consumables enable users to perform many different applications, with variable sample volumes and concentrations in a flexible way. Equipment can be selected and combined to match the specific requirements of the work taking place, while achieving highest reliability. ]]> https://biospectrumindia.com/news/97/7991/neem-sequence-database-to-be-made-public-soon.html https://biospectrumindia.com/news/97/7991/neem-sequence-database-to-be-made-public-soon.html Fri, 15 Mar 2013 15:50:54 +0530 When Ganit Labs, a fledging public-private partnership had sequenced Azadirachta indica, more commonly known as the humble Indian plant neem in late 2011, it was lauded as a remarkable achievement done by an Indian lab. However, what differentiated it from other such discoveries was the fact that the sequencing information was going to be made available to the public. Click here to read more about Ganit Labs' achievement of sequencing Neem genome Now, more than a year later, Ganit Labs is ready to launch the online portal with the valuable information in the form of a sequence database. The portal will house partially annotated data. Dr Binay Panda, head, Ganit Labs, says that completing the annotation is not their priority right now. "We want to focus on secondary metabolites of the plant and especially the genes and pathways involved in producing them. We want to primarily explore the synthetic biology aspect, and use this information to understand and utilize the antiseptic and insecticidal properties of neem." The raw data surrounding the sequencing effort has already been published and can be accessed online. Ganit Labs is a public private partnership between Strand Life Sciences and the Institute of Bioinformatics and Applied Biotechnology (IBAB). The Government of India had solicited proposals to develop a BioIT lab in India a few years ago. The government of Karnataka and Strand Life Sciences were chosen to be a part of this initiative. It received Rs 10 crore from the Department of Information Technology, Government of India, and Rs 5 crore from the Government of Karnataka. Strand Life Sciences too invested Rs 5 crore worth in software and marketing services rendered. Apart from the Neem project, Ganit Labs is also working on mapping the epigenetic changes that take place in different stages of oral cancer, a major health problem found in India. The aim behind this to be able to use preliminary information of markers in oral cancer in developing a diagnostic to detect oral cancer early. Dr Panda believes that the information, which will be freely available should enthuse students and researchers to further work on enhancing our understanding of the existing data. "I think we should let people exploit the data. CSIR's Open Source Drug Discovery (OSDD) program is an excellent example of a crowd sourcing initiative. We don't have the size comparable to that, however, it is an excellent example to emulate." ]]> https://biospectrumindia.com/news/97/5710/ims-institute-for-healthcare-informatics-launches-branch-in-india.html https://biospectrumindia.com/news/97/5710/ims-institute-for-healthcare-informatics-launches-branch-in-india.html Fri, 08 Mar 2013 14:41:38 +0530 The IMS Institute for Healthcare Informatics recently announced a new initiative to develop local partnerships with leading universities, research institutions, development agencies and the government to reinforce the value of information and analytics in decision making across a range of healthcare issues in India. The India branch of the IMS Institute for Healthcare Informatics, with the support of IMS Health India, will leverage relationships in the public and private sectors to deliver objective, relevant insights and research to advance the country's health agenda. Murray Aitken, who heads the IMS Institute for Healthcare Informatics, said, "The transformation of healthcare systems to better serve the needs of patients worldwide can be energized through a tighter linkage between information and decisions. There is a tremendous opportunity to ensure that the best available information - including IMS's unparalleled global information and analytical assets - is applied as critical reforms are undertaken across India. Through the India branch, we are establishing a platform for collaboration among academia and the country's private and public sector stakeholders to help drive the creation of critical research networks, greater information sharing and the innovative mapping of disease burdens." In India, the IMS Institute's activities will focus on three areas. Firstly, by mobilizing and advancing health services research, the institute will bring together leading policy advisors, educators, researchers and medical care providers to initiate research activities and apply evidence-based approaches to address key healthcare issues. Secondly, for capacity-building and professional training, programs that harness the unique knowledge and expertise of IMS researchers and specialists will be developed for key decision makers, including healthcare executives, hospital administrators and policy makers. Also, for analytics-based performance improvement, the institute will support efforts by health institutions to use performance-based analytics and Business Intelligence tools to drive informed decision making and improved healthcare costs and outcomes. "This is an exciting initiative, and my colleagues and I are looking forward to advancing this distinctive agenda in collaboration with India's healthcare stakeholders," said Dr. Gopa Kumar Raghavan, who heads the India Branch of the IMS Institute. "IMS Health's information, insights and global perspective will provide a unique foundation for critical dialogue to accelerate healthcare development and encourage effective policy decision making." ]]> https://biospectrumindia.com/news/97/5680/5-steps-to-strengthen-approval-procedures-for-clinical-trials-.html https://biospectrumindia.com/news/97/5680/5-steps-to-strengthen-approval-procedures-for-clinical-trials-.html Thu, 07 Mar 2013 18:11:33 +0530 The government of India has taken five following steps to strengthen the approval procedures and monitoring mechanism for clinical trials of drugs in the country to ensure that safety, rights and well-being of clinical trial participants are protected: 1.12 New Drug Advisory Committees (NDAC) consisting of leading experts mostly from the Government medical colleges and institutes from all over the country have been constituted to advise the Central Drugs Standard Control Organization (CDSCO) in matters related to approval of clinical trials and new drugs. 2. Applications of Investigational New Drugs (IND) i.e, New Drug Substances which have never been used on human beings are evaluated by an IND Committee, chaired by the director general, Indian Council of Medical Research (ICMR). 3. Registration of clinical trial in ICMR's registry at www.ctri.in has been made mandatory. 4. Guidelines for conducting inspection of clinical trial sites and sponsor / Clinical Research Organizations (CROs) have been prepared. 5. To further strengthen the regulatory provisions and the monitoring mechanism of clinical trials in the country, the Drugs and Cosmetics Rules, 1945 have been amended as follows:A. Amendment vide Gazette Notification G S R 53 (E) dated January 30, 2013 specifying procedures to analyze the reports of serious adverse events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines. B. Amendment vide Gazette Notification G S R 63 (E) dated February 01, 2013 specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance. C. Amendment vide Gazette Notification G S R 72 (E) dated February 08, 2013 providing for the requirements and guidelines for registration of ethics committee. ]]> https://biospectrumindia.com/news/97/4605/bruker-opens-two-new-centers-of-excellence-in-mumbai-and-bengaluru-.html https://biospectrumindia.com/news/97/4605/bruker-opens-two-new-centers-of-excellence-in-mumbai-and-bengaluru-.html Mon, 04 Mar 2013 12:52:13 +0530 Bruker, a leading provider of high-performance scientific instruments for molecular and materials research, as well as for industrial, clinical and applied analysis, celebrated the grand openings of its new Mumbai and Bengaluru Centers of Excellence (CoE) this week. For over three decades, Bruker has grown its presence in India, with sales and service capabilities in most major cities in India, including New Delhi, Mumbai, Bengaluru, Chennai, Kolkata, Lucknow and Hyderabad, as well as several other Indian cities. This year, Bruker is expecting approximately $50 million in revenue in India, employing over 100 staff, complemented by several high-quality distributors with service capabilities for some of Bruker's product lines. Bruker's new Centers of Excellence in Mumbai and Bengaluru will now offer a new, even higher level of customer support in the important and growing Indian markets for scientific and analytical instrumentation. Bringing together a wide range of Bruker divisional operations in India, the new CoE facilities will offer customers access to multi-technology applications, training and demonstration capabilities. These Centers of Excellence will also aim to support research collaborations between Bruker and key customers in India. Their locations were chosen for their proximity to major academic, government and industrial research laboratories, and also to major hubs for the strong Indian pharma, biotechnology and CRO industry, as well as to major clinical research centers, and to important centers for the cement, metals, manufacturing, food and other industries. Dr. Frank Laukien, Bruker's president and CEO, commented, "With this significant investment in our two new Centers of Excellence, Bruker has taken a major step forward in India to provide highest-level support for the outstanding and rapidly growing Indian research, industrial and clinical communities." Bruker is a leading provider of high-performance scientific instruments and solutions for molecular and materials research as well as for industrial, clinical and applied analysis. Its long-standing presence in and support for the Indian research community began with initial NMR anf FT-IR installations almost 40 years ago. Bruker is a leading market and technology player in many fields, including magnetic resonance (NMR, preclinical MRI, EPR), atomic force microscopy (AFM), stylus and optical metrology, tribology and mechanical testing, EDS and EBSD accessories for 3rd party electron microscopes, X-ray diffraction and crystallography, X-ray and spark-OES elemental analysis, life-science, clinical and applied market chromatography and mass spectrometry, as well as infrared and Raman spectroscopy. ]]> https://biospectrumindia.com/news/97/3103/opto-circuits-appoints-krishna-sudheendra-as-group-cfo.html https://biospectrumindia.com/news/97/3103/opto-circuits-appoints-krishna-sudheendra-as-group-cfo.html Mon, 04 Mar 2013 12:26:15 +0530 Opto Circuits a leading developer and manufacturer of medical equipment and interventional devices for the global markets, appointed Krishna Sudheendra as the Group Chief Financial Officer. This was approved by the Board of Directors in their meeting held on March 1st, 2013. Most recently, Krishna was the CFO at UST Global, a global IT services and solutions provider. Over 9 years with UST Global, he successfully secured funding and investment to scale the company through an exciting growth phase. In addition to strengthening global operations, he implemented strong financial systems and controls to optimize performance and productivity. He implemented best in class corporate governance, risk and compliance frameworks. During this period, he also established credible relationships with investors, bankers and financial institutions. In 2011, Krishna was nominated by Orange County Business Journal, as "CFO of the Year - 2011" for his contribution to the company. Krishna is a Certified Public Accountant from Denver, Colorado and is a member of The Institute of Chartered Accountants of India. Opto Circuits is a vertically integrated multinational medical technology Group that specializes in primary, acute and critical care products for the global markets. Group companies such as Cardiac Science, Criticare, Eurocor, Mediaid, AMDL and Unetixs Vascular are leaders in cardiac and vital signs monitors, emergency cardiac care equipment, vascular treatments and sensing technologies. Commenting on the appointment, Vinod Ramnani, Chairman and Managing Director, Opto Circuits, said, "We gladly welcome Krishna Sudheendra as Group Chief Financial Officer of Opto Circuits. Considering his international professional experience in the key areas of financial management, he will be able to add value to the Company immediately. Additionally, his strong relationships and a track record of performance improvement will lend depth and strength to our global leadership team. As a Company, we are well positioned for the next phase of growth." ]]> https://biospectrumindia.com/news/97/1098/tcs-adjudged-a-leader-in-life-science-drug-safety-services.html https://biospectrumindia.com/news/97/1098/tcs-adjudged-a-leader-in-life-science-drug-safety-services.html Sat, 02 Mar 2013 11:48:29 +0530 Tata Consultancy Services (TCS), a leading IT services, consulting and business solutions organization, announced that it has been designated as a leader in life science drug safety services (DSS) by the prominent global market intelligence firm, IDC. Among the attributes that earned TCS its leadership position in the "IDC MarketScape: Worldwide Life Science Drug Safety Services 2013 Vendor Assessment" are the company's significant industry expertise, strong drug safety IT and KPO delivery capabilities and investment in drug safety specific IP assets. IDC MarketScape reports are designed to identify factors conducive to success in a particular market, both long term and short term, and then assess vendors participating in the market against these factors. The criteria for each IDC MarketScape report is developed by IDC analysts and can include discussions, surveys and interviews. For this report, the key criteria for defining excellence included; breadth of service offerings, diversity of resources and infrastructure-supporting services delivery, project experience in the Life Sciences DSS outsourcing market, customer service strategy and customer satisfaction, pricing model, go-to-market capabilities and commitment to growth and innovation in the R&D DSS space. The report's author, Dr. Alan S. Louie, research director, Clinical Development Strategy and Technology, IDC Health Insights says, "TCS' large life science customer base, broad industry-centric services portfolio, competitive pricing, and strong commitment to growth ensure that the company will continue to be a leading service provider to the industry over both the near and long term." Debashis Ghosh, president, Life Sciences, Manufacturing and Energy at TCS said, "For TCS and our life sciences customers, patient safety is the absolute priority and we are honored to be listed as a Leader by IDC Health Insights in the Drug Safety market. This recognition is a testament to our commitment to our customers, of constantly innovating and delivering superior drug safety services, and helping companies in ensuring enhanced care for their patients." TCS' drug safety services help customers enhance efficiency, reduce costs significantly and ensure regulatory compliance. ]]> https://biospectrumindia.com/news/97/3256/gvk-biosciences-announces-new-distributor-in-taiwan.html https://biospectrumindia.com/news/97/3256/gvk-biosciences-announces-new-distributor-in-taiwan.html Wed, 27 Feb 2013 17:28:42 +0530 GVK Biosciences a Hyderabad based leading provider of databases and services to the life sciences industry, has selected GGA as its distributor for its Informatics Database products and services in Taiwan. Speaking on this development, Sreeni Devidas, Vice President, Business Development, Informatics, GVK Biosciences said, "Genesis Genetics Asia Corp. is recognized as the premier distributor in the life sciences industry in Taiwan and we are pleased to work with a high caliber sales team that will help expand our customer base in the region. GGA will be responsible for distribution of the SAR, Biomarker and Clinical Outcomes databases and would also promote the BioIT and Data Curation services offered by GVK BIO." Dr. Pei-Li Li, Vice President, Molecular Science Center, Genesis Genetics Asia Corp said,"GVK BIO's comprehensive products and superior BioIT services are powerful additions to GGA's portfolio in informatics business. We are pleased to become GVK BIO's distribution partner as it will enable our company to provide researchers in the Taiwanese pharma-biotech industries with such great tools. The ability to search for the desired biomarkers; make queries and compare drug structures and activities; analyze, design and predict the successful outcome in clinical trials will give impetus to Taiwan's pharmaceutical industry in progressing ahead." ]]> https://biospectrumindia.com/news/97/4844/sigma-aldrich-announces-expansion-of-its-gss-center-in-india-.html https://biospectrumindia.com/news/97/4844/sigma-aldrich-announces-expansion-of-its-gss-center-in-india-.html Tue, 26 Feb 2013 18:39:47 +0530 Sigma-Aldrich Corporation, a leading life science and high technology company, today announced the expansion of its Global Shared Services (GSS) center in India which supports the company globally by offering value-added capabilities to drive business growth and accelerate operational excellence. Today, India is one of the Company's key locations where the spectrum of activities includes material sourcing, manufacturing, QC testing, packaging, distribution and GSS. The GSS Center, situated in Bangalore, spans 45,000 sq. ft. and is fully operational. The opening of the new GSS facility closely follows the recent celebration of Sigma-Aldrich's 20 year anniversary conducting business in India and is another recent example of the company's continued investment in talent and commitment to the Asia Pacific region. "India remains a major focus for Sigma-Aldrich," said Karen Miller, Senior Vice President of Corporate Development and Corporate Communications, Sigma-Aldrich Corporation. "With GSS, we will leverage our capabilities, talent and infrastructure in India to better serve our global customer base." Miller added, "Our highly educated colleagues in GSS are supporting many of our global functions, including strategic marketing, sales support and business analytics. From transactional to highly strategic responsibilities, our GSS India employees are helping to support our global business growth and accelerate operational excellence." Sigma-Aldrich Corporation has showcased noteworthy Asia Pacific investments in the last few years, including opening of a new packaging facility in Bangalore, opening of a new facility in Wuxi, China, which is now fully operational and completion of a new SAFC Hitech precursor manufacturing facility in Taiwan. "APAC remains a key area of focus for our Company not only from a growth perspective but also in terms of infrastructure support for our global franchise," said Jason Apter, Vice President and Managing Director, Asia Pacific. The company recently reorganized to enhance focus on core market segments to better attune solutions and services to meet the needs of a diverse customer base. The company defined three new strategic business units - Research Markets, Applied Markets and SAFC Commercial. Each intends to tailor product innovation programs, sales and marketing channels, and customized solutions in a manner that best suits the specific needs of the customer segments they serve from research to manufacturing. "In challenging economies, successful companies are those that are best able to meet their customer needs and our markets in Asia Pacific are no exception. We need to continue getting closer to our customers, increasing service level and launching more local products" said Apter. "To reinforce this commitment, we are excited to be bringing the Vetec brand of products to Asia Pacific and an expanded consumables offering to provide more complete solutions for various research and applied market segments. We continue to leverage our global capabilities and customize them for the needs of our local markets." The expanded product portfolio is expected to be available in India by the second quarter of the year and already is being distributed in other regions within Asia Pacific. ]]> https://biospectrumindia.com/news/97/5594/healthcare-providers-in-india-to-spend-rs-57-billion-on-it-in-2013-says-gartner.html https://biospectrumindia.com/news/97/5594/healthcare-providers-in-india-to-spend-rs-57-billion-on-it-in-2013-says-gartner.html Mon, 25 Feb 2013 15:42:46 +0530 Healthcare providers in India will spend Rs 57 billion on IT products and services in 2013, an increase of 7 percent over 2012 revenue of Rs 53 billion, according to Gartner, Inc. This forecast includes spending by healthcare providers (includes hospitals and hospital systems, as well as ambulatory service and physicians' practices) on internal IT (including personnel), hardware, software, external IT services and telecommunications. Telecommunications, which includes telecommunications and networking equipment and services, will remain the largest overall spending category throughout the forecast period within the healthcare providers sector. It is expected to grow 3.9 percent in 2013 to reach Rs 17.2 billion in 2013, up from Rs 16.6 billion in 2012 - most of this growth will be in enterprise communication equipment. Internal services will achieve the highest growth rate amongst the spending categories - forecast to be 18 percent in 2013. Internal services refer to salaries and benefits paid to the information services staff of an organization. The information services staff includes all company employees that plan, develop, implement and maintain information systems. IT services will achieve the next highest growth rate amongst the spending categories - forecast to grow 9.7 percent in 2013 to reach Rs 14.5 billion in 2013, up from Rs 13.2 billion in 2012 led by growth in process management and consulting. "Rising demand from the growing middle class in India's large cities is fueling growth in private sector healthcare. Large national and state government programs will spur growth along the primary (and secondary) care sector and public health domain," said Anurag Gupta, research director at Gartner. "Hospital information systems, picture archiving and communications systems, electronic health records and mobile technologies will be high on the agenda. We expect to see providers benefit by offering cost effective business models which show quick returns on capital by improving patient coverage and improving quality of care. Health insurance growth will also catalyze technology adoption in healthcare provider segments." ]]> https://biospectrumindia.com/features/97/6819/progress-through-innovation.html https://biospectrumindia.com/features/97/6819/progress-through-innovation.html Fri, 22 Feb 2013 13:21:48 +0530 Rank 3 Agilent Technologies is one of the few players which has a complete portfolio of mass spectrometry techniques that spans the various application needs of the industry. In FY 2011-12, Agilent India's life sciences business is estimated to be Rs 365.7 crore as compared to `318 crore in FY 2010-11. Bulk of Agilent's Life Sciences and Chemical Analysis (LSCA) business comes from sale of its products and solutions to the pharma sector. The expansion of LSCA Center of Excellence and the setting up of application development lab have helped it to accelerate the discovery of life science analysis work flows; both making it the largest research facility in the world. The acquisition of Varian has broadened and strengthened Agilent's product portfolio. Similarly the decision to acquire Dako, a leading cancer diagnostics solution provider, has opened new avenues for the company. Agilent signed a research sponsoring agreement with Amrita University for providing consumables valued at $10,000 and offers extensive service and support. The company along with Department of Science & Technology (Government of India) and Confederation of Indian Industry launched the third season of nationwide i3 innovation competition for all innovators. Over the years, Agilent's mass spectrometry products have also seen a big jump in revenues. The company has introduced many new products including automated card extraction LC/MS system, a fully integrated instrument for analysis of dried blood spots and other dried media, integrated UHPLC-DAD system, and 2D-LC solution with highest resolution. The next generation Agilent 7100 Capillary Electrophoresis (CE) system has been claimed to provide at least 10 times more sensitivity than any other commercial CE instrument. Its industry-bench marked 1200 series HPLC and 7890 GC have been the biggest revenue generators. Agilent's Rapid Resolution LC (RRLC), has been a big success in the pharma segment. Agilent also launched 6420 triple quadrupole LC/MS system, a replacement for the 6430 and 6460 systems. Besides that, the company recently introduced 6550i Funnel quadrupole time-of-flight chromatography mass spectrometry (Q-TOF LC/MS) system. The world's leading premier measurement company is expanding its thought leadership to introduction of new products and commiting to extensive research. ]]> https://biospectrumindia.com/features/97/4703/25-years-of-excellence.html https://biospectrumindia.com/features/97/4703/25-years-of-excellence.html Fri, 22 Feb 2013 13:18:23 +0530 Rank 2 Celebrating its silver jubilee in India, Waters India crossed Rs 458.5 crore in revenues last year. Waters India is the fastest growing Waters subsidiary in the world with a growth rate of over 26 percent. The strength of Waters India lies in the fact that the company is sharply focused on the separations segment, that has allowed Waters India to maintain a leadership profile. Today, almost 70 percent of the large and medium sized pharma companies in India use a Waters' product. It has been widely credited for pioneering the ultra performance liquid chromatography (UPLC) systems worldwide. As the adoption of UPLC systems in quality control departments picks up pace, a strong growth in this segment is foreseen by Waters. Waters India announced a host of new product launches in 2011-12. Three products were introduced in the mass spectrometry segment which includes the TQD tandem quadrupole mass detector. In the UPLC segment, Waters launched UPC2/Unify system and UPC I class. Another remarkable achievement for Waters India was the first sale of its new product, UPLC Square, that was launched in India in May, just within a month of its global launch. In 2011-12, Waters India garnered a market share of 30 percent in the mass spectrometry domain. The liquid chromatograhy domain, which is considered to be company's strong area, held over 40 percent of the total market sales. In terms of allied products, Waters' signature software Empower for liquid chromatography systems, is used by thousands of scientists in India. Waters entered into a collaboration with the Tecan group to bring in better automation of routine clinical laboratory assays. By combining Tecan' s Freedom EVO liquid handling platform with Waters Acquity TQD liquid chromatography/mass spectrometer (LC/MS/MS) systems, Waters has been efficiently able to automate sample preparations. In terms of investments, Waters India has been focusing on strengthening the applications laboratory in Bangalore, which develops solutions for Indian customers. This center also caters to increasing the knowledge base of trained individuals, by providing necessary training courses. It has also initiated online ordering by opening a new order center. ]]> https://biospectrumindia.com/features/97/4540/regional-growth-strategy-is-the-key.html https://biospectrumindia.com/features/97/4540/regional-growth-strategy-is-the-key.html Fri, 22 Feb 2013 13:09:01 +0530 Thermo Fisher Scientific today has a majority market share across segments such as mass spectrometery, gas chromatography, centrifuges, cold storage, incubators, portable material characterization to process technologies, and environmental monitoring. It is also a major supplier of laboratory chemicals (Qualigens) as well as high-quality consumables such as liquid handling pipettes and chromatography columns. Thermo has successfully integrated its recent global acquisitions in India which include Phadia, Dionex and TKA. Its biosciences revenue has increased by 28 percent as its sales stood at Rs 598 crore in FY 2011-12 as against Rs 467 crore in 2010-11. The company has made significant investments in building a robust infrastructure in India and on skilled talent. It has also been streamlining investments in warehousing and stock points across the country and has implemented a new ERP system across most businesses. Thermo Fisher is investing in R&D projects out of India as well as increasing its manufacturing capacity. The company has also launched a range of new products over the past year. It recently announced new launches in its chromatography and mass spectrometry portfolio. These include Thermo Scientific TSQ 8000 Triple Quadrupole GC-MS system, Trace 1300 gas chromatograph, Q Exactive Plus mass spectrometer, and Nano Drop Lite spectrophotometer. In its laboratory products business, Thermo Fisher has enhanced its presence in the controlled environment storage segment with the launch of its advanced line of Thermo Scientific Forma and Thermo Scientific Revco ultra low temperature freezers. Thermo Fisher has also enhanced its molecular biology workflow with the latest launch of three new PCRs. Thermo Fisher has witnessed an increased business from its clinical services unit in Ahmedabad which is understood to be the only MHRA-approved site in South Asia. The company recently launched Unity Lab Services. "We have globally launched Unity Lab Services, which will revolutionize our customer experience by including enterprise solutions, asset management, remote services, consulting apart from our existing services such as installation, commissioning, validation services, spares support and annual or comprehensive maintenance and user training. We hope to roll out this new service brand in Asia Pacific soon," says Amit Chopra, MD, VP and GM, Thermo Fisher Scientific India. ]]> https://biospectrumindia.com/features/97/5219/biosuppliers-industry-clocks-rs-5324-crore.html https://biospectrumindia.com/features/97/5219/biosuppliers-industry-clocks-rs-5324-crore.html Fri, 22 Feb 2013 12:47:00 +0530 ]]> https://biospectrumindia.com/interviews/97/3034/spinco-chairman-customers-confidence-is-our-success-formula.html https://biospectrumindia.com/interviews/97/3034/spinco-chairman-customers-confidence-is-our-success-formula.html Tue, 19 Feb 2013 16:19:30 +0530 Spinco Biotech is celebrating its 32 years of service to the scientific community in 2013, which is quite a remarkable feat in this industry. Adding another feather in their cap is the sustained and successful 30 years relationship with Shimadzu, one of the global leaders for analytical instruments. The key factor which differentiates Spinco from its competitors is the customer confidence that they have built and the goal to continue to strive for the goodwill that the company has earned from its principals. In a conversation with BioSpectrum, Mr S Thyagarajan, chairman, Spinco Biotech shares his thoughts about Spinco's 30 years of service and also about the latest product launches by the company. Having completed 30 years of customer service, what new can the customers expect from Spinco? Customer expectations have undergone a radical transformation in the past three decades, heavily influenced by the ever-changing market dynamics. Many of our key business relationships today did not exist in nineties. Moreover, the numerous mergers, acquisitions and other forms of investments at multinational company levels have added a global flavor to the customer perspectives. We are today considered consultation partners by many of our key accounts exalting us from the distributor status of yesterday. Competing with global companies for their share, our customers expect from us an excellence in terms of service. To accord a 24x7 support and thus minimize downtime, we are also expected to organize workshops, to conduct trouble-shooting training, to help users in method development and at times to perform a technology assessment or sample analysis. Having understood this paradigm shift in customer demands, we are equipping ourselves with necessary talent and infrastructure. What are the latest products of Spinco Biotech? Any upcoming technology in the life science segment? Interestingly, analytical and life science instrumentation are a continually innovating process that goes with evolving new technology. These innovations take place not only in the design of instruments but pave the way for new applications hitherto not available. Some of the instruments in our portfolio today, especially in the life science segment were developed in the last ten years, thanks to the the human genome project, resulting in an exciting range of high-end instrumentation. In chromatography, Shimadzu is constantly improvising on their instrumentation in line with the varying customer expectations. Only few years back Shimadzu had launched the UHPLC Nexera and last month Shimadzu had introduced a newer version of UHPLC Nexera X2 with iPDeA (Intelligent Peak Deconvolution Analysis), with the world's highest sensitivity, unrivaled spectrum resolution and superior stability for UHPLC/HPLC analysis. For scientists working in proteomics, Shimadzu has launched an Integrated Protein Digestion HPLC, the Perfinity iDP. In the mass spectrometry segment, Shimadzu is approaching the market with their Ultra Fast Mass Spectrometer series. Over the years, we have supplied equipment ranging from tabletop lyophilizers to production scale instruments. However, as new pharmaceutical manufacturing facilities get established exclusively for export to countries like the US and Europe, FDA certification becomes a mandatory posing a huge challenge. This calls for totally automated systems and we have to our credit a few on-going installations of fully automated largest capacity lyophilizers from Hull. Spinco is known for its strong relationship with global partners such as Shimadzu and SP Scientific. Tell us more about that? We take pride in our 30 years of partnership with Shimadzu. Shimadzu's strong support and continuous encouragement are our major reasons for success in this market. In fact, many of our offices across India were inaugurated by one of the directors of Shimadzu Corporation. For instance, our supply chain management centre, that was set up to streamline consumables and spares delivery for separation science product line, was inaugurated by Dr Teruhisa Ueda, director of Shimadzu Corporation in 2008. Our 55,000 sqft customer support centre at Hyderabad, that was built in 2010 to celebrate the milestone of 10,000 Shimadzu HPLCs in India, was inaugurated by Mr Yasunori Tokumasu, another director of Shimadzu Corporation. SP Scientific is another principal with whom we have completed two decades of partnership. At the recently held Global Partners Meet of SP Scientific, we have been awarded '2012 Channel Partner - Worldwide'. We are also proud of our sustained relationship with principals like Molecular Devices, Daicel, Foss, Kinematica and others. Are there any plans for new partnerships, collaboration or acquisition? Moving from a vendor perspective, we are today known as a company for bringing newer technology to the research lab that is clearly reflected in our tagline 'Bringing Technology, Enabling Science'. While seeking newer and novel technologies that we bring to the scientific community, we follow a work flow based applications approach. In Life Science, we have recently partnered with Hamilton for sample storage and liquid handling automation and robotics to address high throughput and complex pipetting needs, facilitate controlled sample archival and retrieval. Newer technologies like digital molecular bar-coding for the study of multiplexed gene expression at a single cell level, molecular forensics for completely automated human identification, high throughput microbial screening and a platform for advanced microbial genetics are also being planned. 'LyoZone' is our customer solution centre that we are setting up with SP Scientific to support the increasing Lyo-customer base with a view to provide an opportunity to scientists not only to see the equipment, but also to run product trials and to perform cycle characterization/optimization for their specific applications. Similarly, to cope up with the increasing demand for homogenization technology in pharmaceutical, chemical and food industries, we are also planning to set up a centre of excellence for mixing and homogenizing in association with Kinematica. Currently, MNCs are having a strong footprint in India. As an Indian player, how do you see this scenario? Different business models work differently, but the basic goal is to meet and support customer expectations. Though globalization has brought a few subsidiaries of multinational companies to India, most of them still rely on distributors owing to the large topography that needs to be covered and also the customers preference to known contacts, valuing longer years of relationship. Ultimately, what is important is - to be close to customers and to extend support as and when they need it. Appropriately, Shimadzu has set up two full-fledged customer support centres in Mumbai and Delhi to help the distributors to offer training, demos, and sample analysis. How did the idea to establish the Indian Institute of Chromatography and Mass Spectrometry happen?In commemoration of our 30 glorious years of serving scientists in chromatography, we founded the Indian Institute of Chromatography and Mass Spectrometry (IICMS) in 2010. Dr Venkat Manohar, until recently the senior vice president of Piramal Life Sciences is heading this institute as director. The vision of IICMS is to nurture and develop future experts in the field of chromatography and mass spectrometry. The institute has entered into MoUs with some of the universities and more than a dozen industrial projects focusing on mass spectrometry have been completed in the past two years. It has also etched its modest presence in the international arena through presentations of three papers at the American Society for Mass spectrometry (ASMS) held in Canada in May 2012 and two more at the International Mass Spectrometry Conference (IMSC) in Kyoto in September 2012. To date, two national conferences on mass spectrometry have also been held in 2011 and 2012, that had attracted the who-is-who of mass spectrometry in this country. What are your future plans for the company?Our vision statement defines our goal - to build long lasting relationship with our customers. Spinco Biotech has become a lab-hold name across the country. This is achieved through continuous strengthening of our sales, marketing and support capabilities. Our short term approach to achieve this goal is to be the preferred partner to the Indian scientific community. Towards this end, we participate in activities from the time a scientist starts conceptualizing a project. We build capabilities, so our customers can recognize us as consultants in early stages and as a partner, as the project progresses. In the long term, Spinco is aiming to be the best and the most trusted and valued technology enabler for the scientific community.   ]]> https://biospectrumindia.com/news/97/4157/embl-uses-viscotek-tda-for-protein-characterization.html https://biospectrumindia.com/news/97/4157/embl-uses-viscotek-tda-for-protein-characterization.html Tue, 19 Feb 2013 10:20:42 +0530 Researchers at the European Molecular Biology Laboratory (EMBL) in Hamburg, Germany, have incorporated a multi-detector array size exclusion chromatography (SEC) system from Malvern Instruments (Viscotek TDA -Triple Detector Array) at the laboratory's powerful small angle X-ray scattering (SAXS) beamline to improve the productivity and quality of detailed protein characterization work. The use of the Viscotek TDA triple detector array system prior to analysis provides complementary biophysical data and simultaneously purifies samples for measurement. This results in more information and better quality data from each experiment. This innovative set up is not only limited to the institute itself, but is widely accessible to structural biology researchers via BioStructX, a European Commission initiative that creates a single gateway to Europe's leading synchrotron facilities. Both Malvern Instruments and EMBL Hamburg are partners in the BioStructX project which brings together facilities from across Europe to establish a stateâ€?ofâ€?theâ€?art coordinated and multiâ€?site infrastructure to support access for key methods in structural biology. The new integrated SEC-SAXS set up was developed by a number of experts within EMBL, and with input from Malvern Instruments to enhance the department's offering to BioSAXS users transnationally. The automated multi-pronged characterization it offers has already demonstrated its significant advantages to the first users and is expected to be in considerable demand as the BioSructX project advances. Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world. SEC produces a fractionated sample for measurement, separated on the basis of hydrodynamic size. The Viscotek TDA incorporates refractive index, UV and light scattering detectors which in combination provide concentration and absolute molecular weight measurement for these eluting fractions. Integrating this system with the SAXS beamline provides it with purified samples for measurement that give enhanced signal-to-noise ratios and high quality data. In combination with the biophysical information from the TDA these data provide detailed information about the internal shape and structure of proteins that advances understanding of their behavior. In particular SAXS data is valued for the determination and monitoring of the low resolution structures and conformational changes that proteins exhibit. ]]> https://biospectrumindia.com/views/97/6934/new-trends-to-drive-analytical-market-ahead.html https://biospectrumindia.com/views/97/6934/new-trends-to-drive-analytical-market-ahead.html Mon, 18 Feb 2013 17:07:00 +0530 The government of India on December 17th lowered the economic growth estimate for 2012-13 to 5.7-5.9 percent as against the 7.6 percent projected by Economic survey in March. This sluggish growth in 2012 has impacted our industry adversely affecting the business. However, this downward pattern is not unique to India as many advanced economies and emerging ones have reported similar downhill trends. The Indian analytical, laboratory and life science instrumentation market, valued around $1billion is struggling to achieve its projected growth of 10-15 percent this year. This decline in business has escalated the cost of sales while shrinking margins in a market where customers' expectations of support is significantly higher. Our focus is on two important market segments - chromatography-mass spectrometry and life science and we hope that the continued expansion and growth in pharma and biotech industries and thrust by government in academia and research laboratories will help us to achieve a minimum of 10 percent growth in 2013. - Mr S Thyagarajan, chairman of Spinco Biotech group of companies Analytical instruments industry has faced very challenging market conditions in 2012 due to combination of many factors including but not limited to global and Indian economic conditions, high inflation and depreciation of currency in India. But the future looks brighter, particularly for the pharmaceutical and life sciences market. Pharmaceutical industry has registered close to 15 percent growth so far in this financial year. To sustain growth, capital investment is mandatory and we expect companies to make large capital purchases in Q4 FY 2012-13 and the following year. Due to regulatory, legal and administrative hurdles, the clinical research market has slowed down significantly in the past two years. Progress has been made by issuing robust regulatory guidelines with compensation mechanisms and we expect the sector to emerge once again in the forefront of global scene as the advantages of doing clinical trials in India continues to attract global players.   Waters is ready and poised to take total benefit of the re-energized Indian market with new products and services in 2013. With our focus on providing total solutions to our customers, we will be launching new HPLC and UPLC products in 2013 along with strengthening our portfolio of award winning Ultra Performance Convergence Chromatography products. Above all our highly qualified, experienced and dedicated team across various cities in India is ready to provide world class service and support to all our customers to ensure their continued success. - Mr KV Venugopalan, president, Waters India BioPharma market is growing and everyday injectable drugs and vaccines are administered to improve health of millions of patients around the world. West works with its health care partners to design and manufacture drug packing and delivery systems to bring those drugs and vaccines from concept to the patient more efficiently, reliably and safely. As global healthcare need changes, West has evolved to meet and exceed those needs by understanding the challenges our customer face and nuances of a global market. Majority of the biopharmaceutical drugs are injectables and West is there trusted partner for packaging and delivery globally. - Mr Alagu Subramaniam AR, country manager, West Pharmaceutical Packaging India The overall biotech industry growth would be 8-10 percent mirroring the reduced economic growth projections (5.5 to 6 percent). The biggest influencer of this would be the government research institutions where the funding has become very sluggish and erratic for most part. Lifescience technologies and services providers like us would need to provide a solutions approach rather than just products to strengthen our position in the market. Ground level support to our customers especially in using cutting-edge products and technologies would be key. BioPharma would remain a key growth sector spurred by cost conscious healthcare systems across the world. CROs on the other hand may have a mixed impact based on the projects which are coming their way from big pharma customers. I have heard of slowing down in projects. Agribio and food would be promising sectors especially as legislation and enforcement architecture gets strengthened. Export oriented industries as well as prominent brands would take the lead in the food sector. Agriculture including animal products would also look to new technologies to enhance the quality and yield of their products. Healthcare - translational health and diagnostics would continue to grow but would look at cost effective validated options, which will help in penetrating to smaller markets. - Mr Devashish Ohri, managing director - South Asia, Life Technologies Outlook for Genomics sector is bright in 2013 - in the academic sector, Genomics is increasingly being applied and in the industry sector pharma diagnostics and AgBio are the key growth sectors. Hi Seq and Ion Proton are going to be the main Next Generation Sequencing (NGS) platforms and Agilent Microarray platform will complementing it for copy number studies as well as confirmation of the NGS data. - Dr Raja Mugasimangalam, CEO, Genotypic Technology Genome Sequencing, performed using a popular method called Next Generation Sequencing is currently limited in understanding complex diseases and rare diseases. But very soon with the promise of $1000 genome it is believed that sequencing will be used in clinical setups frequently for delivering individualized therapeutics. The United Kingdom recently pledged £100 million for 100,000 patients with cancers or rare diseases and Norway has recently pledged to incorporate genome sequencing into its national healthcare system. With all the limitations Sanger Sequencing gave way to the most efficient NGS that is revolutionizing the field of genomics. It is believed that this NGS technology can be put to use to understand and come up with smart solutions for some of the major challenges such as food security, health security, energy security and environmental security that the world is facing today. It takes about 10 to15 years for a drug from inception to market; it takes decades to improve a crop. The critical challenge in 2013 will be to start thinking-how to shrink this timeline? Questions will be asked-shall we invest few billions and 12 years for a blockbuster drug or invest few millions and few years for personalized medicine? In agriculture, we will be asked questions like can we simulate part of the breeding cycle in a computer and see results in months? Can we search terabytes of data and identify biomasses that can be used for commercially viable diesel? NGS data has already changed the biology experiments of 21st century - it has converted biology from a confirmatory science to exploratory science. - Mr Prahalad Achutharao, CEO, Geschickten Biosciences ]]> https://biospectrumindia.com/news/97/1445/metrohm-foss-collaborate-for-analytical-solutions.html https://biospectrumindia.com/news/97/1445/metrohm-foss-collaborate-for-analytical-solutions.html Mon, 18 Feb 2013 14:50:08 +0530 Metrohm and FOSS have entered into a strategic alliance strengthening the two companies' leading positions in their respective key markets. In this strategic alliance, Metrohm will become the sole global distributor of FOSS Near-Infrared (NIR) instruments for the chemical, petrochemical, pharmaceutical, and environmental sectors. "Metrohm will extend its product offering beyond the company's traditional focus on solutions for wet-chemistry analytical techniques thereby benefiting our customers with new possibilities both in laboratory and process analysis," said Dr Christoph Fässler, CEO of Metrohm. FOSS will continue its strong R&D program within NIR technology and manufacturing for both companies. "The strategic alliance allows FOSS to focus its NIR business on the food and agricultural industries that we have served for more than 50 years, while continuing our leading position within NIR technology - and making this technology available to a broader customer base," said Mr Torben Ladegaard, CEO of FOSS. Under the deal, FOSS NIRSystems, based in Laurel, MD, USA, will become a division of Metrohm USA to be named Metrohm NIRSystems. "With Metrohm's strong worldwide presence, commitment to the pharmaceutical and chemical industries, and with this investment in NIR the alliance allows us to further grow our business within these sectors and provide our customers with a steady stream of new innovative NIR products and the highest level of support," said Dr Philip Irving, president of FOSS NIRSystems. The global NIR instrument business for these sectors will continue to be run by the Metrohm NIRSystems division of Metrohm USA. Family-owned FOSS is the world's leading supplier of dedicated analytical solutions that ensure optimal quality and production of food and agricultural products. FOSS solutions analyze and control products during production - helping to optimize both quality and profit. FOSS has manufacturing and research and development facilities in Denmark, Sweden and China with headquarters in Hilleroed, Denmark. Solutions are sold and supported through 27 FOSS sales and service companies in Europe, Americas and Asia/Pacific, as well as through an extensive global network of distributors. Metrohm has been catering to the electrochemistry and ion analysis needs of various industries including the pharma and biotech industries in India through its subsidary Metrohm India. Metrohm started its operations in India in June 1997, as a joint-venture with Micro Devices. Later in June 2008, Metrohm India was launched as a 100 percent subsidiary of Metrohm AG, Switzerland. ]]> https://biospectrumindia.com/features/97/3099/crams-the-next-big-wave-.html https://biospectrumindia.com/features/97/3099/crams-the-next-big-wave-.html Fri, 15 Feb 2013 17:03:04 +0530 A recent study based on the analysis of intellectual property generated by Indian CROs suggests a rather discouraging outlook of drug discovery in India. While this is a matter of concern for all, the study does not take into account contract research in preclinical biology and this is where I believe lies a huge opportunity for us. There are only a handful of CROs in India focusing on translational research. With immense potential and capabilities, I believe next few years will witness Indian CROs making a bigger contribution to global drug development. In the coming year, Dabur Research Foundation (DRF) will strengthen its expertise in the area of human adult stem cells. We will continue to add to our repertoire of animal-free models for evaluating cosmetics. Last but not the least, with the Indian guidelines for developing botanical products round the corner, DRF is well positioned to carry out end-to-end development of botanical products leading to an IND filing. - Dr Manu Jaggi, vice president (R&D), Dabur Research Foundation Anthem is on a tremendous growth path at the moment and we expect to see that continuing in the coming year. Our industry is experiencing tough conditions, brought on by the continuing turmoil in big pharmaceutical companies and poor economic health of western economies. Europe is rocking back on its heels, Japan is moribund and the US is in pretty bad shape too. I see a tough environment for new players. Anthem however, has had five years to consolidate its position and we will surpass 50 percent growth this year. We have built a reputation of being a delivery oriented contract research player. We expect this momentum to carry through and make Anthem companies even more sizable players in our space. The Indian economy should pick up growth and we see a tremendous boost in our business which is domestically focused. We have made new investments in laboratories, manufacturing and products development. With these investments coming on stream in 2013 we expect a significant multiplier effect. In my view the established players should get bigger but the space will continue to be tough for new entrants or "me too" companies. -Mr Ajay Bharadwaj, CEO, Anthem Biosciences We believe that early stage drug development in the form of chemistry/biology outsourcing will continue to grow in 2013. CRO's with integrated capabilities and co-located chemistry/biology laboratories would benefit from this trend. At TCG Lifesciences (TCGLS), we have created a highly efficient and economic "innovation engine" with a demonstrated ability to run Structure Activity Relationship (SAR) loops in a "faster-cheaper-better" manner. Furthermore, CRO's with domain specialization and technology platforms will have a larger role to play in this innovation process. At TCGLS, we have geared ourselves to become a preferred partner for our pharma/biotech clients in the therapeutic areas of pain, inflammation and CNS disorders. This has enabled us to deliver 4 preclinical candidates in 2011-12 and other successful stage gate advancements in 2012-13. We will continue to build deeper domain expertise and multi-disciplinary specialist teams to tackle the challenges that lie ahead. We are also broadening our service domains in the high growth segments of crop science, nutraceutical, cosmeceutical and animal health. - Mr Swapan Bhattacharya, managing director, TCG Lifesciences I believe that 2013 will be a defining year for us as well as the Indian bioscience industry when much of what was discussed and debated in 2012 will come to fruition. Quintiles India's plans are closely aligned with these developments which include: Significant growth in peri-clinical services. The dynamics of the changing biopharma industry and growing recognition of the transformational role data-driven services can play in driving value for customers is a big opportunity for us. We are uniquely positioned to offer customers solutions that are derived from 30 years of global healthcare expertise and highly evolved technology skills and will continue to build on the strong foundation of data-driven services we offer from India. Continued growth in the domestic biopharma sector. In 2012, the mix of domestic biopharma companies in our portfolio grew and we see this trend continuing in 2013. Indian customers are looking to partner with firms who can support not just their global growth aspirations but also those who have relevant knowledge of emerging markets, including deep subject matter and regulatory expertise. The biosimilars segment is another big opportunity for us at Quintiles India. Much has been said about the potential of India in biosimilars development. With the Indian biosimilars regulatory framework now in place, we will see a lot more biosimilars development in India which will augur well for organizations such as ours who have strong biosimilars expertise, understanding of the prescriber pool, access to patients and experience in diverse regulatory environments. Finally, I believe 2013 will see a strengthening of the regulatory environment for clinical research in India. This has been an area of much debate in 2012 which will hopefully result in a more robust and well-defined policy framework in 2013. - Mr Anil Raghavan, managing director, Quintiles India                                                     ]]> https://biospectrumindia.com/interviews/97/5820/indian-customers-are-not-receptive-due-to-cost-factor.html https://biospectrumindia.com/interviews/97/5820/indian-customers-are-not-receptive-due-to-cost-factor.html Thu, 14 Feb 2013 14:36:47 +0530 Pharmalab, which was started in 1962, celebrated its 50 years of service, which is quite an achievement in the Indian supplier industry. Continuing with its tradition of collaborating with international players, Pharmalab is strengthening its existing partnership with Germany-based Skan, by launching a new range of laboratory instruments. BioSpectrum caught up with Mr Karnik Parikh, director, Pharmalab and Mr Daniele Bazzicalupo, head, Sales Management, Skan AG, Germany in Mumbai to understand their perspectives and their expansion plans. Share with us your thoughts on Skan's collaboration with Pharmalab? Currently, what products do you plan to introduce in the Indian market? Mr Bazzicalupo: We have been working with Pharmalab since three years. In the past, it was just our representative company, but now we are strengthening our bond. Skan primarily manufactures and distributes aseptic barrier isolator technologies that are used in sterility testing and other applications. These are made available in India through Pharmalab. Soon, we will start marketing our own range of laboratory equipment. We also hope to introduce products from basic instruments such as laminar hoods to more advanced lab equipment. In our view, as compared to last year, things are starting to take shape in Indian market for us, thanks to our relationship with Pharmalab, which has increased our visibility. India is a very interesting market for us and we hope to explore it further. Mr Parikh: We are very happy with the way this collaboration is shaping up, especially with the new developments. For the laboratory equipment range, we are looking to create a separate group for marketing them, depending on the market response.   What was Pharmalab's gross revenue for the last financial year?Mr Parikh: Last year, the Pharmalab group revenues were Rs 85 crore. The group consists of three verticals, Pharmalab India, the main company, that also handles the overseas expansion of all divisions; Pharmatech, which is into process equipment; and Liquipec, which handles packaging equipment.In the past, Pharmalab has focused on the African and the South American markets. How has that experience been and do you plan to explore countries in the APAC region as well? How does Skan view India and other APAC markets?Mr Parikh: Exports contribute to almost 37 percent of our total revenues. We have a good customer base in APAC countries like Indonesia and Thailand. We will now focus on Vietnam and Cambodia along with continuing investments in other countries like Russia. We have also been very successful in Middle Eastern market. Mr Bazzicalupo: Apart from India, in the APAC region, China is the country with the most customer base for Skan. We also have a fully owned subsidiary in Japan and will continue to explore our options in other parts of Asia in future. Can you elaborate on the locally manufactured equipment distributed by Pharmalab?Mr Parikh: We manufacture distillation systems, sterilizers and more, keeping in mind the necessary international norms. We have installed many of such systems in India and would have also exported these worldwide to almost 30 countries by now. In countries like Turkey, Greece and Russia, where the customers require this equipment at a reasonable price, we are able to cater to suit their needs. Wherever we can locally manufacture, we will do so. Since we have laid an emphasis on local manufacturing in our operations, we are well placed to absorb any modern technology. Many other companies who have decided to focus on distribution cannot do so, as they lack the design infrastructure. We have the ability to better service this equipment locally, and hence the reduced costs. In which market segment is Pharmalab playing a leading role?Mr Parikh: We have the largest, of more than 70 percent in water systems, for steam generation and injecting systems. We have a decent market share in sterilizing equipment. Though we are a late entrant into the freeze dryer technology, we hope to have a strong foothold in the future. We are also confident about attracting the market for high end equipment such as isolators in the next 3-5 years. What are your observations on the trends in life sciences segment in the last year?Mr Parikh: There hasn't been much increase in the spending from biotech companies as compared to the last year. The equipment that we market is quite capital intensive. They are high end products and has a good market potential but, Indian customers are not immediately receptive because of the cost. Yet, the requirement do exist, and hence we are seeing a slow and steady interest being generated in the biotech and pharma industry. With respect to that, we have also decided to intensify our efforts. In terms of Skan equipment, some of them, which are of special interest to companies in India and China will be locally manufactured, whereas the rest will be imported. This will help us save some capital and make it attractive for the customer. ]]> https://biospectrumindia.com/news/97/3047/strand-receives-investment-from-burill-company.html https://biospectrumindia.com/news/97/3047/strand-receives-investment-from-burill-company.html Thu, 14 Feb 2013 13:12:14 +0530 Strand Life Sciences has raised Series B investment from San Fransisco-based Burrill and Company. Burrill and Company is a diversified global financial services firm focused on the life science industry. It is the sole investor in this round. The financing included both a primary investment into Strand Life Sciences and a secondary buy-out of the lead Series A investors. The proceeds of the financing of the Series B is to accelerate the growth of the company's evolution into precision diagnostics in healthcare and expand Strand's reach into global markets. Strand will leverage its expertise in genomics and analytics that it has developed over a decade.Speaking on the occasion, Dr Vijay Chandru, founder, chairman and CEO, Strand Life Sciences, said that, the company is delighted that the world's premier investment fund in the life sciences industry chose to support Strand. This investment will help Strand realize the true potential of its proven strengths in data science and multi-disciplinary bench analytics by taking them into the clinic. Dr Tania Fernandez, director, Burrill and Company added, "Our investment in Strand Life Sciences reflects our continued commitment to the life science sector in India. We constantly analyze the Indian life science landscape, in search of leading edge platform technologies and products, helping companies develop these to full potential and expanding their access to global markets. Strand is a leading-edge bioinformatics company developing healthcare applications. We intend to work with Strand to help them build a preeminent position globally in what we consider the future of medicine: next-generation sequencing (NGS) and its applications in healthcare." Strand Life Sciences had won the BioSpectrum-ABLE Bioinformatics Company of the Year 2012 as the leading bioinformatics firm in India with estimated revenues of Rs.49.14 crore.Over 2000 research laboratories worldwide (about 30 percent of global market share) are licensees of Strand's technology products as are several leading pharmaceutical and biotechnology companies. Strand and its partner Ganit Labs share additional 10,000 square feet of laboratory space with state of the art clinical genomics capabilities and capacity for pre-clinical toxicology assays of lead compounds.   ]]> https://biospectrumindia.com/news/97/3093/data-is-exploding-in-biotechnology-say-researchers.html https://biospectrumindia.com/news/97/3093/data-is-exploding-in-biotechnology-say-researchers.html Tue, 12 Feb 2013 14:21:00 +0530 "The role of Information Technology (IT) in biological research is of paramount importance. IT is leveraged in biological researches as a technical advancement. It has influenced biotechnology and bridged the void to help us come-up with the solutions for data storage and analysis. BioIT is widely used in diagnosis. The missing links in diagnosis using classical methods can be corrected using BioIT tools. Algorithms can be used to check genes that may be switched on or switched off. Protein interactions can be studied better. Cure for a particular disease can be found out in less amount of time. In fact, the pharmaceutical industries also use it extensively," said Mr Ananth P, research scholar, Institute of Bioinformatics and Applied Biotechnology (IBAB), an autonomous institute set up by the Department of IT, BT and S&T, Government of Karnataka. Speaking on his research at a session on "BioIT and Leveraging IT power to make affordable medicines" at Bangalore India Bio 2013, Mr Ananth said, "Systems biology is used to identify micro molecules in type 2 diabetes and its progression into other complications and computational structural biology is the other area. In the case of cholera, the proteins and RNA come into the picture. Algorithms are used to analyze protein sequences to predict and visualize their 3D structure. Proteins help in the search of structure and function." He went on to say that 38 percent of proteosome are uncharacterized i.e. of unknown function. Experimental techniques are costly. This is where IT comes to play its role for sequence database, PFAM database, evolutionary information of domains and 3D structure of proteins. Ms Meeta S, research scholar, IBAB said, "As a botanist, the objective is mainly using plants to solve nutritional problems for the poor. By sequencing lysine rich dicot amaranthus hypochondriacus, which is an essential amino acid. It means that this amino acid has to be taken externally through food and is not produced in our body. Deficiency of lysine in our body leads to protein energy malnutrition in toddlers i.e. kwashiorkor."Amaranthus, she says, has high yield. "Many edible species of Caryophyllales are also sequenced. DNA is processed and sequenced and its textual form is derived. Next comes quality control, followed by assemblers and then reconstructed genome after deleting overlaps are received. The final process is downstream analysis using languages like LINUX," she said. Mr Saurabh G, research scholar, Ganit Labs, speaking on the Next Generation in Bioinformatics said, "The need for bioinformatics is primarily because of the large data, microarray, dissimilation studies, large amount of samples to handle, manage, store and share. It is integration of IT with biological research. Data explosion may occur as we can not store huge data on personal computers and laptops. Hence we need high tech tools such as next generation of sequencing (NGS) to keep and analyze the required data. Sequencing is not that costly but analyzing the sequenced data is a costly one." Dr Kshitish Acharya, faculty scientist, IBAB and founder and director, Shodhaka Life Sciences, said, "Data is exploding in the field of biotechnology in the present day. So here comes a great need and hence demand for analyzing them, thus creating a huge opportunity." ]]> https://biospectrumindia.com/features/97/6528/tighter-clinical-trial-regulation-is-need-of-the-hour.html https://biospectrumindia.com/features/97/6528/tighter-clinical-trial-regulation-is-need-of-the-hour.html Mon, 11 Feb 2013 12:29:00 +0530 Recently, the Supreme Court managed to stir the $600 million (Rs 3,246 crore) Indian bioservices industry, when it asked for greater accountability from the Drug Controller General of India (DCGI) for the conduct of clinical trials. The general perception was that, this would serve as a blow to the the sector, which witnessed a growth of over 15 percent in 2011-12 as against the previous year's growth of 23 percent. However, at a recent annual conference on clinical research organized by Indian Society for Clinical Research (ISCR), industry experts opined that the court order should not be taken as a setback, but rather as a measure to keep spurious practices at bay. Ms Suneela Thatte, executive director, Customer Operations, Quintiles says, "The court order does not disempower clinical research organizations (CROs) in India and should not make a major difference. It only asks for the previous directives to be followed. This includes furnishing details in different cases such as the one where the relevant states are being asked to submit all the data surrounding the clinical trials for the Supreme Court to study." A copy of the Supreme Court order, in possession of BioSpectrum, explicitly asks the Central Drugs Standard Control Organization (CDSCO), India's main regulatory body for pharmaceuticals and medical devices or the Ministry of Health and Family Welfare (MoHFW) to submit the affidavit as requested earlier within four weeks. It has also directed the chief secretaries of all states other than Madhya Pradesh, Manipur, Dadra Nagar Haveli, Daman and Diu to file written responses on an affidavit. Finally the Supreme Court reiterated by saying that, clinical trials regarding any new drug should be carried out under the direct supervision of the secretary, MoHFW until further notice. Besides, referring to the 59th Parliamentary Committee Report, which had indicated a collusion between pharma companies and regulatory authorities, the apex court further pointed out that the government needed to wake up and address the situation. Last year, several media reports surfaced claiming that clinical trials were being conducted without the patient's consent, resulting in deaths of the patients in states such as Madhya Pradesh, Andhra Pradesh, and other North East states of the country. Considering the severity of cases, Swasthya Adhikar Manch, a Madhya Pradesh-based NGO, filed a Public Interest Litigation (PIL) with the Supreme Court. In response, the apex court asked the Madhya Pradesh government to constitute a committee to oversee the conduct of any clinical trials in the state and formulate guidelines to regulate the trials. The Supreme Court then, on October 8, 2012, asked the Ministry of Health and Family Welfare to submit an affidavit with the details of clinical trials conducted along with the deaths and compensation associated with them. Due to the noncompliance of this specific order, the Supreme Court reprimanded the representative of the ministry for "slipping into a deep slumber" and not submitting the information.   However, the data regarding clinical trial sites, number of deaths associated, and compensation paid, traditionally lies with the central approving authority, the DCGI. Industry sources say that, asking the state governments to furnish these details, without outlining the procedure will only result in more delays, since many would be ill-equipped to handle such requests. Sharing his views on the developments, Mr Ranjit Sahani, vice chairman and MD, Novartis India said, "There is no need for us to make a knee jerk reaction to the apex court order. It is time for us to take a step back and analyze the situation and assess what all the stakeholders in the clinical trials industry need to do in this situation. There is a need for clear communication about issues such as compensation to be discussed by the government." Dr Krathish Bopanna, CEO, Semler Research Centre and also president ISCR seconds Ms Thatte by saying, "The order should not affect any legitimate CRO in India, as it only asks for the reinforcement of existing rules. It is directed towards outfits which are fly-by-night operators, who have been indulging in malpractices that are in the news." In a similar instance, on January 8, 2013, the Supreme Court responded to a PIL filed against vaccine majors, Sanofi Pasteur MSD and GSK (GlaxoSmithKline) for allegedly conducting clinical trials on nearly 24,000 tribal girls in Andhra Pradesh and Gujarat, even before the vaccine was licensed by the DCGI. The Supreme Court has not only directed the Union Government to respond to the allegation, but also asked Christian Medical College, Vellore to analyze the medical reports of the girls who allegedly succumbed during the trials. Delays aboundThe Supreme Court orders and the subsequent debate over clinical trials in India have only dampened the operations in the CRO space in India through indirect repercussions felt by the industry in the form of delays. Since 2011, the 12 new drug advisory committees (NDAC) that were set up to review new drug applications in different areas of specialization such as neurology and cardiology, were supposed to respond with their comments within six weeks of receiving the applications. These comments were to have been discussed at joint meetings and approvals be granted subject to their responses. In reality, however, industry sources note that no NDAC meeting has been held in the last three months. Some are slated to start this month. However, the inordinate and more so indefinite delays will only make it difficult for small and mid-sized CROs to survive and operate in the coming years.   The bioservices sector has been on the decline since 2005-06, the year when the sector witnessed a growth of 69 percent. Of the current scenario, Dr Arun Bhatt, an industry veteran and president, ClinInvent Research said, "It has become difficult to get clarity on clinical trial approvals for not just drug companies but also academic and research institutes. Delays have become commonplace. What the industry needs now is a change in the mindset, when it comes to approving sites or specific studies." However, no one can deny the existing lacunae in the structure that allow for malpractices in clinical trials to occur. Several measures are being suggested to curb incidences such as those reported in Madhya Pradesh a year back. Ms Thatte suggests a national list for noncompliant sites can be formulated and made public. Other initiatives like publicly blacklisting errant organizations could go a long way in restoring public faith, which of late has taken a severe beating. For now, Dr Bopanna states that they will wait and watch."Since the court order is only asking for CROs to abide by the given guidelines, ISCR will not be initiating any response". Experts from the industry cite that, the need for a strong and robust industry will be felt even more urgently, once, more domestic pharma companies mature and develop drugs in this decade. For this, the organized clinical trials industry needs to take a more active initiative to differentiate itself from the unauthorized entities and co-operate with the country's drug regulator to adhere to the judiciary's requirements. Greater dialogue with more accountability is therefore the need of the hour. ]]> https://biospectrumindia.com/interviews/97/6735/our-facility-will-reshape-indias-analytical-sector.html https://biospectrumindia.com/interviews/97/6735/our-facility-will-reshape-indias-analytical-sector.html Fri, 08 Feb 2013 15:01:00 +0530 AB SCIEX, a global leader in life science analytical technologies, recently inaugurated a new analytical facility at Gurgaon. Set at an estimated cost of Rs 16 crore, the unit was established with the aim to give scientists and laboratory technicians across India, an access to the latest innovations in analytical technologies. In November 2011, the company's Indian unit expanded, with AB SCIEX acquiring the mass spectrometry business of Labindia. BioSpectrum spoke to Mr Rainer Blair, president of AB SCIEX, USA about the company's present operations, opportunities, marketing strategies and future plans. What is the objective of setting up this new facility in India? Mr Blair: This state-of-the-art, scientific support centre is designed to help address some of India's biggest analytical challenges, including food safety, environmental protection, vitamin D analysis, biomedical research, testing of banned drugs of abuse, and the development of new therapeutics and generic drugs. Moreover, scientists and lab personnel in public and private sectors are expected to use it as a destination for proof-of-concept studies, development of new work flows, extensive training and troubleshooting support in method development. The facility in India will allow us to take the lead with our customers to reshape analytical science in this amazingly forward-thinking region of the world. What according to you are the major challenges of doing business in India? What is your strategy?India is a large country and the challenges here are of many fold. First, coverage of all the areas is a challenge along with building capabilities for new technologies. As the new regulatory regimes are being quickly put in place, the high standard needs to be maintained accordingly. To enable that, there has to be an increased need for awareness among the researchers about the latest technology upgradation. Another challenge is the investment in research by the government and the venture capitalists as it is directly related to their purchase capacity. The worst fear for a company is the recall of its product from the market. So new methods have to be developed to suit the requirements of the clients. Our marketing strategy is based on the same and we also believe in creating innovative technologies for the clients. We work relentlessly every day to be a trusted partner with Indian scientists and lab managers.   How has the acquisition of Labindia helped in the growth of the company? Labindia's acquisition has helped the company to create new opportunities for scientific interactions, collaborations and innovation. With its growing local presence and dedicated global resources, AB SCIEX is opening new job opportunities in Indian economy, thereby attracting top talent in science and technology to its portals. Tell us about your unique offerings to clients in India? We are committed to responding to and meeting the growing needs of India's research and applied analytical testing communities. Our new product SWATH will revolutionize the entire proteomics industry. It is changing the way scientists work in quantitative proteomics. Driven by superior speed and high-resolution performance of TripleTOF 5600 system in both mass spectrometer (MS) and MS/MS mode, this technique provides comprehensive quantitative data on every component in a sample in a single injection. As research evolves and new hypotheses are formed, one can re-interrogate a sample without the need to re-acquire data. Another product, AB SCIEX 6500 series provides unprecedented level of sensitivity never before achieved in an LC/MS/MS system. Using the IonDrive technology, new innovations have been implemented in every part of the system. How do you look at the opportunities in the Indian and Asia Pacific market?We are looking at providing the country's highest-rated service and support to Indian customers, who analyze compounds, contaminants and proteins in various fields. We are also catering specially to the biosimilar and biological drug research companies and would like to mention that one of the India's leading companies in this area is using our technology. I find Indian market much bigger than other countries in the Asia Pacific. One thing that is unique about India is its CRO industry. The country is fast developing and the demand for technology is going to multiply in the coming years. How has the growth been in MS market?The growth in the MS market has been tremendous. The demand has increased at an average of 20 percent every year and we are proud to say that we continue to hold a larger share of the market. What is the future outlook for the company?We have achieved the milestone of double digit growth record, which is pretty much unheard of. In the next five years, I see the company's growth to be atleast five times than that of today's size. Our motto here is that, in India, we will always be there for India. ]]> https://biospectrumindia.com/news/97/4009/gvk-extends-biomarker-database-license-with-fda.html https://biospectrumindia.com/news/97/4009/gvk-extends-biomarker-database-license-with-fda.html Mon, 04 Feb 2013 17:57:13 +0530 GVK Biosciences (GVK BIO) is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (USFDA). The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the USFDA in its biomarker qualification process. The GOBIOM database is a comprehensive compilation of all the clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies. GOBIOM contains information on 20,000 biomarkers comprising of biochemical, genomic, imaging, metabolite, cellular and physiological markers, along with multiple data points comprising of experimental, analytical, clinical and statistical data with their qualifications under different medical interventions. Mr Sreeni Devidas, vice president, sales and marketing, informatics said, "The collaboration with the USFDA has helped GVK BIO in developing the safety biomarker content in GOBIOM. The interconnectivity between organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification. Biomarker analysis tools were integrated into the database in a manner that has facilitated the user to make a comparative analysis between the biomarkers of their interest. We look forward to continue working and collaborating with the FDA with a view to enhancing the utility of the product further." ]]> https://biospectrumindia.com/views/97/5439/biosimilars-the-next-emerging-frontier.html https://biospectrumindia.com/views/97/5439/biosimilars-the-next-emerging-frontier.html Mon, 04 Feb 2013 14:46:00 +0530 The first generation of biological therapeutics were developed in the 1980s. The global biological market represents one of the fastest growing sectors in the healthcare industry. With the end of the year 2012 and exclusivity period of most innovator biologics fast approaching, around $79 billion worth of innovator biologics are estimated to go off patent in 2015. The global market for generic substitutes for original biologics is expected to grow to $10 billion by 2015. This surge can be attributed to the growing preference to targeted therapies, some of which have greater benefits over conventional drugs. However, unlike the conventional generic drug molecules, the complexity of the product coupled with lack of any knowledge on the innovator's clone, differences in the breakdown products and potential immunogenicity issues, pose serious challenges in introducing a generic equivalent. The European Medicines Agency (EMA) has been very proactive in providing guidelines and creating a format for the approval of biosimilars. In the US, the Biological Price Competition and Innovation Act (BPCIA) provides a framework for biosimilar approval. The USFDA has approved a few biologics through New Drug Applications (NDAs) and a few Follow-On Biologics (FOB) as Abbreviated New Drug Application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C) 505(b)(2) category; a rapid approval route. The FDA here relied on the safety and effectiveness of the reference product and not the applicant product. For instance, Sandoz's Enoxaparin and Amphastar's Enoxaparin were approved by demonstrating the similarities between the generic and innovator products. In order to scale up to the ever growing demand for these products, manufacturing processes are often changed resulting in a completely new product development program. Extensive changes in the manufacturing process could impact changes in product attributes, warranting more data for ensuring similarity.   The Indian Scenario Currently, the Indian scenario is such that, there are around 25 companies reported to be operating in this niche area. The $338 million industry is growing at a CAGR of 30 percent since 2008. Indian companies enjoy low infrastructure costs for development and have an admirable scientific talent. The recent guidelines in India provide in detail the regulatory requirements for the marketing of similar biologics in India. Right from the host cell line, fermentation process and purification, quality based considerations, toxicity data, preclinical studies and clinical studies, there is a set of mandatory standards, which manufacturers have to abide. Apart from the evaluation of safety and efficacy studies with the innovator or reference product, there is special focus on immunogenicity studies. These guidelines echo the emphasis by EMA and USFDA guidelines. However, with respect to reference products, the EMA guidelines have no provisions for non-EMA licensed reference products, whereas the USFDA does consider if adequate data or information can scientifically justify similarity in case of a non-US licensed product. Indian regulators have been accommodative in permitting the use of reference products if they have been granted marketing approvals in countries with well-established regulatory systems like the EMA and the FDA. Around 85 percent of the world population resides in countries where the regulatory guidelines are not well defined. These emerging markets with a huge unmet need have their own local guidelines for manufacturing and developing biosimilars. Although there is a similar thread running across all the guidelines issued by EMA, FDA, and the regulators in Australia, Canada and Japan, a strategic partnership between the well regulated countries and the emerging markets could augur well for the development of global biosimilars. ]]> https://biospectrumindia.com/views/97/8086/big-data-big-challenges.html https://biospectrumindia.com/views/97/8086/big-data-big-challenges.html Mon, 04 Feb 2013 14:34:00 +0530 Our ability to make simultaneous measurements on several tens of thousands of genes or even on the entire DNA in a biological system has improved many-fold over the last several years. The cost of making these measurements has also been reducing continually. This has enabled researchers to generate candidate genes/mutations of interest far more quickly than previous gene-by-gene methods. This has also brought about the need for researchers to add one more dimension to their research toolbox-the need to handle big data. Big data could mean different things in different contexts. In the context of a research lab doing molecular biology research today, big data typically signifies a five GB file of raw data for every sample run; and a typical experiment can have tens or even hundreds of samples, reaching hundreds of GBs in size. These have to be processed by special algorithms before their sizes can be compressed to the scale of 10s to 100s of MBs, amenable for exploration and discovery. The algorithms are in a semi-mature state at the moment: algorithm developers across the world have built and made available open source and commercial tools that will allow researchers to do the same. However, as measurement technology continues to change, these algorithms are evolving as well. And with it, there is an increasing need for many more algorithms and tools. While many research groups in India use available tools effectively to answer their research questions, few have contributed new tools and algorithms for use by the community at large. Though much of our effort at Strand Life Sciences does go towards this goal, through a commercial setting, via our GeneSpring and Avadis NGS products; I do know of few academic initiatives in this direction as well. This needs to change in the future via a multi-disciplinary involvement of computer scientists, statisticians and biologists, under key umbrella initiatives that could be undertaken in India towards understanding the Indian population (similar to, for example, the 1000 genomes project). Note that the above paragraph defines big data largely from the perspective of a single research lab generating up to a few 100 GBs of data a year, which is the typical case in India. But there is a case to be made for aggregation and pooling of data across labs. For instance, mutation hunting requires knowing how often a particular mutation occurs in the population at large, which could benefit from the pooling of normals or controls across labs and studies. In essence, we are talking about the creation of central genomic repositories with modern interfaces that are very easily accessible and usable by researchers at large. This is where the real problem of big data hits; data sizes can reach TB (terabyte) and PB (petabyte) scales. There are of course ways to reduce these sizes, and there are several groups across the world building such infrastructure, including our group at Strand. However, researchers in India haven't had an impressive history of pooling data or creating central bioinformatics resources; this is something that should change in the future. There is a third definition of big data that might confront us in the future. A whole industry is working on bringing the cost of whole genome sequencing down. It currently stands at about $1000 (internal cost that is, the cost of selling and deploying usually multiplies this many-fold, but that is guaranteed to reduce with maturity). If and when the cost reduces by another factor of two-three, it may become feasible for individuals to get their genomes sequenced proactively, regardless of immediate medical need. There are several examples of genomic variants providing warnings for individuals to monitor aspects of their health more aggressively (for instance, the now famous Indian mutation in the MYBPC3 gene that 1 in 25 Indians have and that almost always causing ventricular wall thickening post age 45). A whole genome raw file is close to 100 GB, and this multiplied over potentially millions of individuals will yield the biggest of our big data problems. In summary, biological and medical research will drive off big data to a very large extent in the future. With the big data getting bigger over time, multi-disciplinary groups will need to come together to create appropriate infrastructure so we can continue to make efficient use of this big data. ]]> https://biospectrumindia.com/news/97/5022/technology-to-detect-gm-products-in-india.html https://biospectrumindia.com/news/97/5022/technology-to-detect-gm-products-in-india.html Mon, 04 Feb 2013 11:39:44 +0530 Scientists argue that genetically modified (GM) crops are engineered to convey favorable traits such as disease resistance. However, at the same time, the labeling and identification of genetic modifications in commercial products have become a global concern. In India, the ministry of consumer affairs, food and public distribution on January 1, 2013, formally implemented a rule which stipulates that every package containing food derived from products of biotechnology shall bear at the top of its principal display panel the letters "GM". With this kind of regulation in place, it is the implementation part that has become important for the authorities. At present, in India, there is availability of a technology that may be of help to the industry, especially agri-biotech sector and the regulators. This technology "Fluidigm Biomark HD System with Dynamic Array Integrated Fluidic Circuits (IFCs)" priced between Rs1-2 crore depending on the specific system, has been brought to India by New Delhi-based Premas Lifescience, the biosupplier division of Premas Biotech. The researchers through a study have claimed to demonstrate the utility of this system, which is also called as qdPCR 37K (37K) IFCs for real-time GM detection. The real time analysis provided Ct values that identifed false positives and provided greater data confidence. They used Gossypium hirsutum genome (cotton; C=2.40; GM free) and GM event GHB 614 (614) detected by their respective TaqMan assays, to determine the limit of GM detection on the 96.96 IFC and 192.24 IFC for real-time PCR and the 37K IFC for quantitative digital PCR (qdPCR). In this case the pre-amplification was not found to be necessary. The study has concluded that the system enabled fast and accurate methods of low-level GM contamination detection in a high background of GM-free plant gDNA. The executive director of Premas, Mr Praveen Gupta looks at it as an important step towards offering choice to consumers. Revealing his targeted market to BioSpectrum, he explained, "The market we are looking at includes seed companies, GMO testing labs, agri-genetics research universities and institutes. The technology will be used to assure purity and segregation of different events and to trace the genetic modifications by the seed companies and food industry. Also the enforcement agencies can use it to ensure compliance with legislation."  ]]> https://biospectrumindia.com/news/97/3052/dia-to-organize-ectd-training-workshop-.html https://biospectrumindia.com/news/97/3052/dia-to-organize-ectd-training-workshop-.html Tue, 29 Jan 2013 11:35:12 +0530 Leading Industry body DIA (Drug Information Association is organizing a day long eCTD training workshop for pharma professionals on February 4 in Mumbai. This workshop is focused on enabling the participants to compile, publish and validate eCTD submissions with insights on Life Cycle Management and STF compilations. Hands-on training will enable participants to understand regional differences and global submission strategies. Compilation of US M1 and EU M1 will be discussed in detail to empower users with updated information on these major ICH regions. This course is designed for anyone pursuing or intending to pursue Regulatory Affairs, Regulatory Operations, Submissions Management and Electronic Publishing. An interactive presentation will be also given by LORENZ Life Sciences' Professional Services Director, Kent Briggs, who will highlight the latest eCTD activities on a global scale. Attendees will also consider the impact of regional interpretations of eCTD specifications and guidelines on global submissions strategy. ]]> https://biospectrumindia.com/news/97/3054/marck-biosciences-looks-to-african-markets-.html https://biospectrumindia.com/news/97/3054/marck-biosciences-looks-to-african-markets-.html Tue, 29 Jan 2013 11:23:42 +0530 Ahemdabad based Marck Biosciences, a leading manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) specialist, recently opened a new chapter in Africa, with the South African Medicines Control Council (MCC) approving six products manufactured at its Small Volume Parenterals (SVP) facility at Kheda. The South African market, at around $3.8 Billion (2011), is growing at 6 percent and is expected to reach $7 billion in 2018, with generics accounting for 60percent of the volume. The MCC approval will also enable Marck Biosciences to achieve immediate access to key markets including Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Zambia, Malawi and Madagascar. MCC approval is expected to result in waiver of inspection by the authorities of these countries and an easier registration of certified products. For Marck Biosciences, the approval carries the opportunity of accessing some of Africa's most stable growth economies. The Medicines Control Council is a statutory body that oversees the regulation of medicines in South Africa. Its main purpose is to ensure that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.MCC-South Africa's certification is also recognized by 43 participating authorities of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This may facilitate export by Marck Biosciences of certified SVP to PIC/S participating authorities as well as non-PIC/S authorities who accept GMP certificates from PIC/S participating authorities. Speaking on the MCC-South Africa approval, Mr Bhavesh Patel, MD, Marck Biosciences, said, "The MCC-South Africa approval for our Kheda facility will provide further impetus to our current expansion efforts in the African region and PIC/S countries. We would also augment our efforts by our own filing and licensing with new partners in SA. I see strong revenue potential in these under-served markets and we believe that we can make a quantum contribution to healthcare products in these countries." Six products have obtained approvals from MCC-South Africa, including Sterile Water For Injections BP 5/10 ml; Ciprofloxacin Eye Drops 5/10 ml; Timolol 0.25% Eye Drops 5/10 ml; Timolol 0. 50% Eye Drops 5/10 ml; Lidocaine Injection BP 1% 5/10 ml and Lidocaine Injection BP 2% 5/10 ml. ]]> https://biospectrumindia.com/news/97/3666/waters-recognizes-dr-amit-mandals-structural-proteomics-lab-.html https://biospectrumindia.com/news/97/3666/waters-recognizes-dr-amit-mandals-structural-proteomics-lab-.html Mon, 28 Jan 2013 15:08:37 +0530 Waters Corporation, a global organization that has created business advantages for laboratory-dependent organizations, recognized the research in structural proteomics done at the laboratory of Dr Amit Kumar Mandal, Associate Professor- Molecular Medicine and Clinical Proteomics of St. Johns Research Institute, Bangalore as a 'Center of Innovation'. Dr Mandal has set up one of the best labs for structural proteomics, which strives to determine clinically important molecules that are associated with human diseases, in the country. The lab at the institute has resources such as high sensitivity analytical instruments made of finest quality that will help to find and identify the molecules in human tissue, blood and plasma. Mr John Gebler, General Manager of the Waters Centers of Innovation Program said, "The Clinical Proteomics lab of Dr Amit Mandal is the only lab in India, which has got the recognition from Waters Corporation. In the Asia Pacific region this lab is the second one to get this recognition, the first being the Department of Biological Sciences at National University of Singapore headed by Assistant Prof Ganesh Anand." Dr Amit Kumar Mandal joins 19 other researchers and research centers globally recognized by Waters' Centers of Innovation Program. The leading scientists, in partnership with Waters, are using liquid chromatography and mass spectrometry to help shape the future of scientific research and unlock the mysteries of science. Waters Centers of Innovation Program recognizes and supports the efforts of scientists facilitating breakthroughs in health and life science research, food safety, environmental protection, sports medicine and many other areas. ]]> https://biospectrumindia.com/news/97/1218/schott-glass-to-hold-fiolax-academy-for-pharma-packaging.html https://biospectrumindia.com/news/97/1218/schott-glass-to-hold-fiolax-academy-for-pharma-packaging.html Thu, 24 Jan 2013 17:00:26 +0530 SCHOTT Glass India is holding the next FIOLAX Academy on April 26, 2013, in Mumbai. Through this unique training event, SCHOTT offers a specialized intensive program for professionals from from the production departments, quality management, R&D and primary packing development departments of pharmaceutical companies, which can expand their knowledge about glass as basic material for primary packing.This could thus improve the quality and cost level of their own processes and products. This academy is named after SCHOTT FIOLAX glass tubing, one of the world's leading material for use in manufacturing pharmaceutical packaging. The main objective of the program is to share latest information on composition, properties and production of high-quality pharmaceutical glass tubing. At this year's event, global experts from SCHOTT Group will share their knowledge on crucial topics for anyone who works with pharmaceuticals: drug-container interaction, hydrolytic resistance of glass containers, surface alkalinity and pH shift, extractables/leachables, protein adsorption and light protection. Special knowledge will be provided about the impact of glass on the filling processes, e.g. in avoiding breakage risks. "After the success of the first FIOLAX Academy in Chandigarh last year, which saw the participation of more than 50 participants from pharmaceutical companies we focus on Mumbai this year. Last year's response encouraged us to increase participation," explains Mr Sundeep Prabhu, Vice President Marketing and Sales, Tubing Division, SCHOTT Glass India. "As India achieves new milestones at a record speed in this sector, secure primary packaging solutions have become all the more crucial. Through such training events, we help our partners improve their position in the domestic and international markets," he said. SCHOTT holds FIOLAX Academy events in leading pharmaceutical markets all over the world. The program has several modules which can be tailored to specific requirements. With the academy in India, SCHOTT Glass India offers leading pharmaceutical companies there an opportunity to learn more about benefits of using high-quality primary pharmaceutical packaging made of glass.   ]]> https://biospectrumindia.com/news/97/2974/thermo-fisher-launches-cliptip-pipetting-system.html https://biospectrumindia.com/news/97/2974/thermo-fisher-launches-cliptip-pipetting-system.html Tue, 22 Jan 2013 13:37:59 +0530 Thermo Fisher Scientific recently introduced the new Thermo Scientific F1-ClipTip pipetting system, enabling users to deliver consistent, reproducible pipetting with higher-quality results. This ClipTip interlocking technology locks tips securely into place to deliver an airtight seal on every channel. "Researchers are constantly challenged with pipette tips that leak air, loosen or fall off in the middle of their protocols, ruining or contaminating the assay," said Mr Raymond Mercier, liquid transfer product director of Thermo Fisher. "Our new F1-ClipTip pipetting system's breakthrough interlocking design securely locks tips in place, which increases reproducibility, reduces force required to attach the tips and ensures the best possible accuracy and precision." Available for both single and multichannel pipettes, the Thermo Scientific F1-ClipTip pipetting system is simple but powerful. With minimal force, each tip is clipped securely on the F1-ClipTip pipette using a patented three-interlocking clip design. The pipette and tip form a complete seal to secure the sample volume in each tip for enhanced accuracy and precision. Additional features such as an ergonomic design, comparatively lightweight in nature, an adjustable 120° finger rest, patented super blow-out, patented soft-touch tip ejection and a volume lock adjustment make the pipette truly user friendly. ]]> https://biospectrumindia.com/views/97/2975/bioinformatics-gears-up-for-2013-.html https://biospectrumindia.com/views/97/2975/bioinformatics-gears-up-for-2013-.html Mon, 21 Jan 2013 13:16:00 +0530 What we will see in 2013 is that computing, algorithms, and mathematics are being used as microscopes; mining through gigabytes of omic data. Using these technologies we will proceed towards predictable medicine, precision agriculture, high yield crops, and economic biofuel much faster. As a company, Geschickten Biosciences is already designing computer algorithms for cancer research and disease resistant crops. In early 2013, we expect to start working on immunogenetics, pharmacogenomics and biofuels. We have invested substantially in pharmacogenetics and personalized medicine techniques, which we expect will give us returns by end of 2013. We also plan to integrate a flavor of mathematics with computational genetics to develop a technique called "DNA Signal Processing", which we believe will help revolutionize the understanding of the information content in a DNA for better disease management. - Dr Asoke K Talukder, chief scientific officer, Geschickten Biosciences We can see a tremendous growth in pharmaceutical sector as many of blockbuster molecules expired in 2011-12 and pharmaceutical industry is again gearing up to discover new molecules as well as collaborating with small and medium size R&D partners for fastening the discovery process. As far as 2013 is concerned, we are initiating our own R&D projects from January 2013 for discovering lead molecules. We are planning to diversify our business in cosmetology, food and agriculture sector soon by partnering with prominent players in these sectors. We are hoping to show success in 2013 with new molecules in market. - Mr Sahil Kapoor, director and cofounder, head, Global Business Operations, Novo Informatics 2013 will see a renewed interest in high-throughput technology, like next-generation sequencing, in the fields of clinical diagnostics, crop improvement, biodiversity and renewable energy. While the West is embracing high-throughput sequencing in the clinics, India will not see it in the years to come. This is due to less than adequate public spending in technology platforms in government-run hospitals and in training manpower who can use such technology, lack of proper regulatory framework for molecular diagnostics tests, unaffordable price points for diagnostics tests based on high-throughout technology platforms and questionable clinical utility of many of the tests using such platforms. While the clinical arena will be the most-talked about in the coming year, the real beneficiary will be the field of agriculture, including crop improvement and species identification. The private sector in India will not see any of the cutting-edge tools anytime soon due to its unwillingness to invest in basic research and lack of knowledge on how to use the high-throughput technology. But the good news is that with a country of our size, potential and aspirations, there is no escaping to making basic discoveries first before moving to clinics or agricultural fields. Hence, it is just a matter of time before new technology will make inroads into both the industrial and government-run labs. We, at Ganit Labs, will slowly but surely move to see our research play a direct role in the clinic and in the field of applied biotechnology in the coming years. - Dr Binay Panda, head, Ganit Labs ]]> https://biospectrumindia.com/news/97/2963/siro-clinpharm-unveils-new-look.html https://biospectrumindia.com/news/97/2963/siro-clinpharm-unveils-new-look.html Fri, 18 Jan 2013 13:08:00 +0530 SIRO Clinpharm, a leading Mumbai-based clinical research organization, which grew at a strong 40% in 2011-12, unveiled its new brand identity recently. The new look, along with a new logo is set to affirm the recent transformation in the company's business strategy. SIRO Clinpharm which clocked ₹282.8 crore in estimated revenues, had expanded its clinical trial capabilities in Asia and Europe and started alliances with other partners in South Korea and Taiwan in the past year. SIRO has also been the recipient of the Frost & Sullivan "Indian Clinical Research Organization of the Year Award" two years in a row, in 2011 and 2012. The company embarked on an ambitious goal to revamp its business and integrate various functions to deliver better value to its customers, a few months ago. With this transformation, the company aims to focus on customer experience says, Mr Gopakumar Menon, CEO, SIRO Clinpharm. "A differentiated customer experience which can happen only through the delivery of right solutions. This new wave will take SIRO beyond its services and bring in the much valued visionary approach, incessant customer focus and strong governance. At SIRO, we aspire to provide solutions, not just services," he adds. Started by Dr Gautam Daftary, founder and chairman, SIRO Clinpharm less than two decades ago, SIRO has grown from strength to strength over the years, having worked with most of the top global biopharma and medical device companies. Of the transformation, Dr Daftary said, "With the vast experience garnered over the past 16 years, SIRO was set to take a leap forward. With its customer centric leadership, we have built depth in various areas of competencies, leveraging our four pillars - people, processes, technologies and solutions." Mr Menon added that SIRO is one of the few CROs to offer end-to-end clinical development solutions with a competitive advantage of high-end technology, in-house domain expertise and evolving ecosystems in various areas of expertise including but not limited to oncology, diabetes, cardiology, infectious diseases and respiratory system. The launch saw SIRO employees join in from offices across the globe and was webcasted live at all locations from Mumbai, where the new brand identity was unveiled by the company's leadership. ]]> https://biospectrumindia.com/news/97/1302/goose-launches-barcode-solutions-for-drug-industry-.html https://biospectrumindia.com/news/97/1302/goose-launches-barcode-solutions-for-drug-industry-.html Wed, 16 Jan 2013 11:00:00 +0530 Pharmaceutical business re-engineering solutions specialist, Goose recently launched "Goose Tracker", a cost-effective new generation 2D serialization barcode for the pharma industry with a choice to choose online or offline solution to secure and protect both consumers and the pharmaceutical companies. Its multi-level authentication features allow tracking of product throughout the distribution channel including warehouse to customer retail chain. Leading pharma companies like Strides Arcolab, Indoco Remedies and Macleods Pharmaceuticals have already implemented and adopted Goose Tracker for track and trace solution. The company expects a rise in demand and surge in Goose Tracker customer portfolio as pharmaceutical companies get set to implement secondary bar coding which is now compulsory for pharmaceutical exports from January 1, 2013. Goose Tracker incorporates several new changes to suit GS1 global traceability guidelines. It's serialization algorithm generates billions of unique numbers. It does not store serial numbers in the database for enhanced security and includes a dynamic engine to interact with ERP systems for data retrieval. This solution provides offline application for entities in the supply chain that do not have access to the main database. Goose founder and CEO, Mr Deb Pattnaik says,"Goose Tracker integrates with existing applications to securely meet data management and printing needs for packaging and shipping labels. We are working with several government and non-government entities to include changes as and when they are announced." The World Health Organization (WHO) estimates that counterfeit drug prevalence rates fall between 10 percent and 30 percent in the developing world, compared to 1 percent or less in industrialized nations. India exports over $12 billion of its generic drug annually to more than 180 countries. Goose Tracker is designed to enable Pharma exporters complement their bar coding initiative to become reliable exporter of quality pharmaceutical products in the international market and strengthen their fight against counterfeiting.Users can also validate the authenticity of the product by using SMS, IVR or website. ]]> https://biospectrumindia.com/news/97/7556/-yasham-life-sciences-to-market-wakos-phos-tag-products.html https://biospectrumindia.com/news/97/7556/-yasham-life-sciences-to-market-wakos-phos-tag-products.html Thu, 10 Jan 2013 16:54:06 +0530 Wako Pure Chemical Industires announced that they will promote the Phos-tag series of products in Indian market via Mumbai-based Yasham Life Sciences. Phos-tag is a novel phosphate-binding tag at neutral pH (physiological pH), developed by the Department of Functional Molecular Science at Hiroshima University, Japan. It is used for the separation, purification, and detection of phosphorylated substances. The Phos-tag series is manufactured by the NARD Institute, and MANAC, Japan. In May 2010 Wako had taken over the distribution of Phos-tag products from the manufacturers. Protein phosphorylation is one of the most important post-translational modifications. Organisms utilize this reversible reaction of proteins to control many cellular activities, including signal transduction, apoptosis, gene expression, cell cycle progression, cytoskeletal regulation, and energy metabolism. Abnormal protein phosphorylation is related to carcinogenesis and neuropathogenesis. Methods for monitoring the phosphorylation status of proteins (i.e., phosphoproteomics) are, thus, very important with respect to the evaluation of diverse biological and pathological processes. The Phos-tag line of products are used in the recognition of all phosphorylated forms of serine/threonine/tyrosine and do not require radioisotope labeling. Downstream applications followed by mass analysis are also applicable. The Phos-tag line of products include Phos-tag acrylamide; for the specific separation of phosphorylated and non-phosphorylated proteins by SDS-PAGE, Phos-tag Biotin; for phosphate affinity western blotting, Phos-tag agarose; for phosphate affinity chromatography purification, enrichment and separation of phosphorylated proteins using column chromatography, and Phos-tag mass analytical kit for MALDI-TOF/MS analysis along with and SuperSep Phos-tag, which is a precast gel added with Phos-tag acrylamide in advance and can be used immediately after opening the package. Wako Pure Chemical Industries has been engaged in the development and manufacture of high-quality products such as over 35,000 unique antibodies, enzymes, molecular biology kits, organic/inorganic chemicals and analytical standards.   ]]> https://biospectrumindia.com/news/97/1878/gvk-bio-onconova-ink-pact-to-develop-cancer-drugs.html https://biospectrumindia.com/news/97/1878/gvk-bio-onconova-ink-pact-to-develop-cancer-drugs.html Thu, 10 Jan 2013 12:35:07 +0530 GVK BIO, a leading Hyderabad-based contract research and development organization recently announced that they have entered into a joint partnership with Onconova Therapeutics to develop new drugs for cancer. Onconova Therapeutics is a US-based biopharmaceutical company primarily focused on discovery and development of novel small molecules for oncology. The joint partnership will be based in the US and will align research priorities and technological expertise from both the companies to facilitate the moving of certain Onconova oncology assets from early discovery to clinical development stage. Onconova will provide two discovery targets with early chemical equity, while GVK BIO will use its multi-disciplinary discovery platform to advance these programs through lead optimization and investigational new drug (IND) candidate selection. Under the agreement, GVK BIO will gain an increasing share of the programs, up to a 50/50 split, which is based on the achievement of milestones/funding. Onconova retains the rights to buy back the programs. Dr E Premkumar Reddy, founder and director of Onconova and a world-renowned molecular oncologist, will oversee the biology and biomarker aspects of the partnership. He commented about the partnership by saying that, "GVK has a world-class infrastructure and the scientific expertise to support the advancement of these two promising, early-stage programs. We are delighted to start this novel relationship with GVK BIO in our search for efficacious targeted therapies for cancer." Onconova brings a wealth of knowledge in oncology, with an expertise of disease target pathways, hits, and development capabilities in the US, Europe and India. While, GVK BIO brings to the table its broad experience of working with over 200 pharmaceutical and biotech companies across multiple service offerings, a strong scientific pool of over 2000 scientists, and an IP generating capability that has delivered INDs to other clients.   ]]> https://biospectrumindia.com/views/97/5978/trends-in-bioinformatics-market.html https://biospectrumindia.com/views/97/5978/trends-in-bioinformatics-market.html Tue, 18 Dec 2012 17:20:00 +0530 Rapid advances in biotechnology have led to a data deluge which has the potential to radically alter drug discovery landscape and may help personalized medicine to go mainstream in near future. The challenge of tapping this wealth of data to generate new knowledge has given rise to new business opportunities. Arrival of cost-effective human genome sequencing techniques and increasing public and private sector investment in genomics, proteomics and related technologies have given a significant fillip to bioinformatics research and startups in India. Indian bioinformatics market is focused on biological database creation and management; data analysis and visualization tools; and services and IT infrastructure. Companies from IT and life science sector are gradually gaining traction in bioinformatics industry by developing innovative products and services. Biological databases are generating significant amount of revenue for the bioinformatics industry. These databases are accessed by the pharma companies at key steps of the drug discovery pipeline and thus reducing time and money involved in drug development cycle. Bioinformatics companies are providing large scale text mining services to populate relevant information in these databases. Growing volume of data obtained from wet lab and in-silico experiments has given rise to the challenge of storing and managing the biological data. Indian IT companies are addressing these challenges by adapting their existing know-how and developing wide array of new technologies and infrastructure for data storage and management. Cloud computing can be utilized here. Exponential growth of data has made it a very time consuming and challenging task to find the right information at the right time. Custom tools are being developed to enable researchers to carry out faster retrieval of data from databases. Creating tools for analysis and visualization of complex biological data obtained from these databases is another area of growth.   Despite making great strides, bioinformatics industry is facing problems such as interoperability of data, data standards and competition from growing number of publicly available biological databases. Indian companies are joining global consortiums and forums, and participating in collaborative research to solve these issues. Molecular Connections is part of the Pistoia alliance, which has many bioinformatics and pharma companies as its members - trying to evole these standards. There are challenges for small and midsized companies to obtain funding to grow further. In spite of all these problems, the Indian bioinformatics market growth story is intact, and is expected to be in double digits in the coming years. Market seems to be in a consolidation phase and one can expect to see some more consolidation in near future. ]]> https://biospectrumindia.com/interviews/97/7763/mr-trehan-we-will-be-launching-new-product-lines-in-proteomics-and-genomics.html https://biospectrumindia.com/interviews/97/7763/mr-trehan-we-will-be-launching-new-product-lines-in-proteomics-and-genomics.html Fri, 14 Dec 2012 12:39:44 +0530 Started in 1999, GenAxy Scientific with its corporate office in New Delhi and head office in Solan, has made a mark in offering wide product range in plasticware and instrumentation. Equipped with customer friendly, motivated, well learned, qualified and trained personnel in all the departments, and well organized distribution channels comprising of five branch offices and 184 distributors, the company in 2011-12 recorded a revenue of Rs34 crore and has shown consistent growth over the period of time. Its sister concern Future Biosciences too has made significant development in lab consumables business by registering close to Rs5 crore revenue in the last fiscal. In an interaction with BioSpectrum, Mr Navneet Trehan, CEO, GenAxy Scientific talks among other things, the factors which hamper the growth of biosuppliers. How do you measure the performance of GenAxy Scientific in the last year? How have things unfolded for Future Biosciences? The performance of GenAxy in the past year has been excellent. New product lines and extended range of existing products has increased our credibility to many folds. We started offering robotic systems with high-end customized and innovative solutions. This venture is in collaboration with the state-of-the-art technology from Aurora Biomed, Canada and Arise, Taiwan. Started in 2005, Future Bioscience (FBS) has made its presence felt in the Indian market. The company has been registered among the top 50 companies in India in the past two years. Strategic and strong tie-ups with Bisicion, Cleaver Scientific, Grant, and TPP have made FBS a reliable supplier to the scientific fraternity, besides the launch of indigenous range of plastic consumables. How do you differentiate yourself in the competitive biosupplier market? We have extended our operations in proteomics. We are now launching the magnetic beads technology from Axygen. It is going to contribute in a big way in the coming months. We will be launching many new product lines in proteomics and genomics in next six months, after we stabilize our new range of products such as 15/50 ml tubes and the other plasticware range. GenAxy has also launched platelet incubators and a complete range of autoclaves from Nuve. We will also be launching a range of incubators such as shaking incubators and refrigerated shaking incubators. Customers' satisfaction through business ethics makes us different in the competitive market. We value our relationship with scientific fraternity and prove it by giving them world class products and best sale services.     What are the latest trends in the Indian biosupplier market? How do you see the growth of the suppliers market?  The latest trend in Indian biosupplier market is the increased competition due to entry of multinationals in the Indian market. The market too has grown reasonably well by providing ample space for everybody who have been introducing innovative range of products. Government support with the liberal funding for innovation and research and development through different agencies such as Department of Biotechnology, Department of Science and Technology and Indian Council for Medical Research has been a key growth driver for the supplier market. What is that one cardinal thing which is hindering the growth of biosupplier industry? The lack of collective voice among the members of the sector is one of the key factor that is definitely hampering the growth of biosuppliers. There is an urgent need for suppliers to unitedly fight for the challenges before the sector. What is the future outlook for the company? We will be concentrating on developing indigenous products and next few years we will be launching innovative products in the area of plastic ware, reagents, buffers, competent cells and pre-poured ready-to-use petri dishes. The year 2013 will witness the advent of new exciting products with GenAxy's signature of customers' satisfaction through business ethics earmarked on them.   ]]> https://biospectrumindia.com/interviews/97/6927/mr-imamichi-we-are-aiming-at-15-20-percent-growth-over-the-next-year.html https://biospectrumindia.com/interviews/97/6927/mr-imamichi-we-are-aiming-at-15-20-percent-growth-over-the-next-year.html Fri, 14 Dec 2012 12:18:22 +0530 With a view of expanding its customer base, Shimadzu Analytical India has been taking concrete steps towards connecting with its customers through various initiatives. Recently, it organized "Food Safety" seminars in five different cities-namely, Bangalore, Hyderabad, Kochi, Mumbai, and New Delhi-to educate researchers about its existing technologies in the food safety space. In a conversation with BioSpectrum, Mr Imamichi, MD, Shimadzu Analytical India speaks about his plans to focus on the food safety vertical and also about the growth of the life sciences industry. What do you think that differentiates Shimadzu from its competitors? In our perspective, Shimadzu is a complete solutions provider. Take the example of food; there are various contaminants present in the food that require different types of analysis. Shimadzu is uniquely placed in this regard, as it caters to identifying and analyzing all types of impurities. We have specific packages designed for low-level quantification of all types of inorganic impurities as well as matrix-assisted laser desorption/ionization (MALDI)-based solution for biological contaminants. Hence, Shimadzu is a good option for labs looking to tackle all of these issues. Shimadzu India also has the capability of supplying application packages along with the necessary equipment, allowing the user to adopt according to their needs. Also, they are ably supported by our application scientists. All these steps come under our food safety total solutions initiatives. Such measures offer more value for the customer, as compared to just getting equipment from any vendor.  We observe that, the challenge today is to provide the right support team for running the systems. We, at Shimadzu, also conduct over 100 training courses every year, to train the technicians who use the instruments, which shows our commitment to further encourage growth in this field. There are also plans for the expansion of this support centre as well. What have been the recent launches in the life sciences segment? We have expanded our mass spectrometry (MS) portfolio recently with the addition of LCMS-8040, LCMS -8080 and a triple quadrapole GCMS TQ8030, as well as Shimadzu's own chromatography data management system.    To be frank, in the triple quad MS segment, was a late entrant into the Indian market. However, the market is expanding, especially in India where the rate of expansion is much faster than in other countries. So, even though we have entered a bit late, we see the acceptance for the ultra fast mass spectrometry (UFMS) technology among customers. What do you think is the strength of Shimadzu? Shimadzu is very strong in LCMS, GCMS, single quad GCMS, chromatography, single quad LCMS, and spectrophotometers. We have the largest market share in chromatography and spectrophotometers, but we would like to expand it further. We have a market share of 35 percent in chromatography segment, with Shimadzu crossing 14,000 high performance liquid chromatography (HPLC) system installations to date in India. The single Quad MS market has very few players, so our share would be around 35-40 percent. Shimadzu has had a very strong and unique relationship with its distributors. Can you elaborate about it? In the analytical landscape, the Shimadzu family consists of Shimadzu India, plus our marketing partners Spinco, Saksham, Swan, and Toshvin. This makes it one of the largest combined forces for Shimadzu products in India. We have adopted this model of partnering with our distributors, so as to leverage their market reach and experience. What are the trends you see in the market and what are your future plans for growth? The trend we have analyzed so far is that, people are now looking for more high-end instruments such as MS as compared to the chromatography systems before. The depreciating rupee has affected our operations, however as the generics and biosimilars industry grows, we anticipate a corresponding increase in the need for sophisticated instruments thereby fueling further growth. Most of the developed countries have already established their use of this technology. So its emerging markets such as India that hold a lot of promise and have a lot of demand as well. We are aiming at 15-20 percent growth in the coming years, building on our expanded MS portfolio as well as our other initiatives. Additionally, we are in the midst of planning mini seminars on different issues and other activities to penetrate more deeply into our target base.         ]]> https://biospectrumindia.com/news/97/1561/csir-hp-kickstart-cloud-enabled-ehealth-initiative.html https://biospectrumindia.com/news/97/1561/csir-hp-kickstart-cloud-enabled-ehealth-initiative.html Thu, 13 Dec 2012 14:28:00 +0530 India's premier research and development body, Council of Scientific and Industrial Research (CSIR) and Hewlett Packard (HP) announced the launch of a rapidly deployable and fully integrated cloud-enabled eHealth Centre (eHC). The eHC solution has been developed jointly by CSIR and HP. The first eHC has been successfully implemented and tested in partnership with OP Jindal Gramin Jan Kalyan Sansthan, 3M India, Maharaja Agrasen Medical College (MAMC) and Orion eServices at Chausala village in Kaithal district, Haryana. Over 4000 patient visits were recorded in the first 100 days of operation. This initiative is an integral part of the CSIR 12th plan vision for Enabling Affordable Community Health through Information Technology (EACH-IT) and CSIR is providing the required connectivity, medical equipment and infrastructure. HP is providing the required Information technology infrastructure including IT equipment and cloud enabling the electronic medical records (EMR) solution with remote monitoring and consultation and a health policy dashboard. Medical aseptic training, specialized medical consumable kits, electronic stethoscopes, corrosion protection and solar reflective coatings for eHC were provided by 3M India. Orion eServices provided integration of the medical equipment and other devices with the health cloud and training to the eHC personnel. "This initiative of CSIR and HP creates a platform for the fourth paradigm of science, data-intensive discovery, while bringing affordable healthcare services to the doorstep of people. CSIR, is now positioned to use the eHealth Center data for novel discoveries to create ultra affordable health care products and services," said Professor Samir K Brahmachari, chief mentor CSIR-OSDD Unit, director general, CSIR and secretary, DSIR, Ministry of Science and Technology. The eHealth Center is a fully integrated cloud-enabled healthcare solution that can be set up to provide affordable and preliminary healthcare in remote areas that have no immediate access to primary healthcare. The solution integrates medical instruments that collect basic patient health data with an eHC Health Cloud and enables medical diagnosis through remote consultation using built in video conferencing options. This initiative marks the increasing interest of the government in deploying smart healthcare solutions like telemedicine to help provide medical services and reach out to far flung places. The basic health care infrastructure in rural areas in India is based on the population norms of having one Primary Healthcare Centre (PHC) for every 30,000 people and one sub-centre for every 5000 people. A study conducted by the Indian Institute of Public Opinion found that 89 per cent of rural Indian patients have to travel an average of eight km to access basic medical treatment and the rest have to travel even further.   The eHC solution addresses these challenges. It is a solution that is housed in a standard shipping container which can be quickly transported to remote areas of the country by air, rail or land transport. It is affordable and easily deployable as compared to brick and mortar alternatives and is equipped with basic cloud-integrated diagnostic equipment, a telemedicine studio, laboratory and a pharmacy. Paramedics can staff the eHC, with specialist medical interventions provided through remote medical consultation. This minimizes the need for onsite skilled doctors in isolated locations. Remote monitoring of the eHC functioning and its equipment is done through the eHC Health Cloud, minimizing absenteeism and equipment downtimes. The eHC Health Cloud integrates the process of healthcare delivery and health data collection. This centralized patient information sets the platform for data-driven research such as disease surveillance by tracking disease patterns and risk factors. The health profile of the region as well as monitoring of the daily usage of the eHC is enabled by an integrated eHC dashboard, providing comprehensive yet digestible analytics that will help health policymakers. "HP is collaborating with government health authorities and organizations to reinvent medical processes, modernize systems, and develop solutions that dramatically expand access, improve healthcare, and save lives. The eHealth Centre is an example of our commitment to social innovation and to the government's priorities, reiterating our belief of shared value," commented Mr Neelam Dhawan, VP & GM, Enterprise Group and country managing director, HP India.    ]]> https://biospectrumindia.com/news/97/3322/thermo-fisher-scientific-offers-ln2-cryogenic-storage-solutions.html https://biospectrumindia.com/news/97/3322/thermo-fisher-scientific-offers-ln2-cryogenic-storage-solutions.html Tue, 30 Nov -001 00:00:00 +0553 Thermo Fisher Scientific Inc.,offers the Thermo Scientific CryoPlus® LN2 series for long-term storage of frozen cells. Ensuring precise and accurate control over all parameters without complicated programming, the CryoPlus series' ideal combination of liquid nitrogen storage and microprocessor technology is provided for full reliability. Easy-to-use auto-filling technology offers user convenience, along with visual identification of LN2 levels. Accessible with storage capacities of 6318, 13,000, 24,000 and 38,500 vials (2.0ml), the CryoPlus series is believe to meet the storage and space necessities for any laboratory. Furthermore super-low power utilization and no heat elimination present environmentally friendly benefits for today's "green" laboratories.With 16 preset audible and visual alarm combinations provide optimal product protection. Also, a unique 24 tri-color LED element continuously displays the actual liquid nitrogen level and high-level/low-level setpoints, enabling easy visualization of the system status as well as any alarm conditions. Safe sample storage is facilitated through the use of vacuum insulation, minimizing the risk of condensation and ensuring that optimum temperatures are maintained.   ]]> https://biospectrumindia.com/news/97/3638/dr-reddys-on-union-finance-budget-2016.html https://biospectrumindia.com/news/97/3638/dr-reddys-on-union-finance-budget-2016.html Tue, 30 Nov -001 00:00:00 +0553 "On the healthcare front," says Mr Satish Reddy, Chairman, Dr Reddy's Laboratories, "the budgetary emphasis on the sector was fairly muted. While certain initiatives such as the new health insurance scheme or the National Dialysis Services program are good, perhaps a more holistic, well rounded thrust would have served the sector better in delivering good health to those in need of it." He points that the initial outlay of 1,000 crores to fund higher education is simply not enough, given the huge gap and growing need for students to have access to high quality education. "One hopes that the government will build upon this and expand access to higher education to a much larger section of society," he voices. The plan to set up the National Board of Skill Development in partnership with industry and academia is definitely a step in the right direction. Mr Reddy adds, "This move will foster an environment of understanding and collaboration that will ensure skill development is mapped to industry needs, thereby creating more job opportunities in the long run." The finance minister began his speech by articulating the 9 pillars on which his budget proposals were built, that would have a transformative impact on the economy and people. The social sector, including healthcare was in the top 5. ]]> https://biospectrumindia.com/news/97/3718/aimed-welcomes-dops-initiatives-to-establish-medical-devices-industry.html https://biospectrumindia.com/news/97/3718/aimed-welcomes-dops-initiatives-to-establish-medical-devices-industry.html Tue, 30 Nov -001 00:00:00 +0553 Association of Indian Medical Device Industry (AIMED) has congratulated the Government for coming out with this laudable initiative of Dept of Pharmaceutical (DoP)in holding India's first ever Pharma and Medical device centric conference and exhibition and for reaching out to the industry with collaborative intentions. During one hour brainstorming interaction with Union Minister of Chemical and Fertiliser Shri Ananth Kumar along with secretary DoP and other joint secretaries from Ministry of Commerce, MoHFW etc with 16 CEO of Medical Devices Industry to drive manufacturing in India - AIMED raised six critical issues which needed immediate attention of the government to realize India's medical device manufacturing potential. AIMED has also given six key action points for the government to work upon. However, AIMED hs pointed out that the most urgent need of the hour was the unveiling of new policy for medical device sector. "We eagerly await the release of a medical device policy whose draft government had released in June," point out Mr Rajiv Nath, joint coordinator, AIMED. The six issues includes forward looking recommendations which will facilitate creation of vibrant eco-system for medical device manufacturing in the country and reduce humungous import dependency. At the same time, AIMED has pointed out that recommendations on their own were not good enough to ensure desired objective of making India a powerhouse in manufacturing of medical devices. Mr Nath has also drawn attention to long standing and vexing issues such as withdrawal of concessional duty regime, ensuring equitable tariff regime between domestically produced goods and imports to ensure commercial and competitive viability of goods made in India. Till the time, it is cheaper to import, why would anyone invest their time, energy and money in a loss making venture, wondered Mr Nath. He has pointed out that along with zero duty on raw materials, duty on finished imported goods needs to be raised to maximum level to dis-incentivize import based trading and attract foreign investments for manufacturing in India. Mr Nath has also drawn attention to medical device industry's long drawn demand to have a separate 'Dept of Pharmaceutical and Medical Devices ' within a Ministry of Healthcare, apart from the much needed separate regulatory regime for medical devices. Mr Nath has emphasized that there must be separate departments for medical devices and pharmaceuticals working under the same ministry which could be called Ministry of Life Sciences or Ministry of Healthcare Products. He has pointed out that housing both departments for being a facilitating body and attaching an autonomous regulatory body under one coordinating minister would be the most desirable step for faster decision making. "We need one ministry for both medical devices and pharmaceuticals on the line of AYUSH," said Mr Nath. He has strongly recommended bringing an altogether new Act for Medical Devices rather than a new chapter being added to the existing Drugs and Cosmetics Act, 1940. Medical Devices are absolutely different category of products from pharmaceutical, though under the common 'Healthcare' vertical. For some strange reason we have been governed by Drugs and Cosmetics Act, 1940, which as thwarted the growth of medical device industry in India," pointed out Mr Nath. "Now that government is committed to creating a vibrant medical device manufacturing eco-system, then an altogether separate law book and rule book will be more business friendly and help attract investments," said Mr Nath. The new legislation also must ensure that traders and pseudo manufacturers are not permitted to pass-off as manufacturer, he said. Medical device industry also need separate regulator or revamped CDSCO as IHPRA - Indian healthcare products regulatory authority, added Mr Nath. Mr Nath has said that recommendations regarding financial support to manufacturing units, reversal of inverted duty structure, MRP based taxation system, creation of a separate department and separate law for medical devices were of particular significance to give the required push for medical device manufacturing in the country. Welcoming earlier Task Force's recommendation to have a new medical device parks, Mr. Nath pointed out that it was equally important that government invests in strengthening the infrastructure facilities at existing industrial clusters. He expressed hope that government would go extra mile to see that Task Force recommendations are implemented at the earliest by releasing a structured policy. "For 'Make in India' vision to be realized and to make India the factory of the world, these recommendations and additional measures need to be implemented at the earliest," said Mr Nath. Mr Nath has congratulated and thanked Mr Ananth Kumar, union minister for Chemicals and Fertilizers and Dr V K Subburaj, secretary, DoP for their assurances and support to domestic manufacturers .   ]]> https://biospectrumindia.com/news/97/3809/fda-nod-for-toshibas-ct-system.html https://biospectrumindia.com/news/97/3809/fda-nod-for-toshibas-ct-system.html Tue, 30 Nov -001 00:00:00 +0553 Toshiba Medical systems' all-new Infinix 4DCT has received US FDA (United States Food and Drug Administration) clearance with the AquilionPRIME CT system configuration. The Infinix 4DCT previously received FDA clearance with the Infinix Elite cardiovascular X-ray system and Aquilion ONE ViSION Edition CT system configuration. The system significantly improves workflow with its SUREGuidance technology, which allows for automatic transition between modalities. In addition, it is capable of saving significant time by allowing clinicians to perform CT and interventional procedures within the same room and verify treatment success following procedures. "The Infinix 4DCT allows clinicians to plan, treat and verify in a single clinical setting, which negates the need to transfer patients between departments, resulting in anticipated decreases of both procedure time and risk of infection. This also contributes to improved patient safety and satisfaction by minimizing the clinicians' time spent away from patients, allowing them to focus on providing quality care," said Mr Bill Newsom, director, X-ray Vascular Business Unit, Toshiba. Toshiba will showcase the Infinix 4DCT with the Aquilion PRIME CT at this year's American College of Cardiology (ACC).   ]]> https://biospectrumindia.com/news/97/4231/an-orthopedic-app.html https://biospectrumindia.com/news/97/4231/an-orthopedic-app.html Tue, 30 Nov -001 00:00:00 +0553 A team of 16 Bucknell University students have developed a mobile application called Heel Thy Tendon, with the help of an orthopedic surgeon. This application can diagnose, and treat foot and ankle problems. The idea was the brain child of professor of computer science Mr Xiannong Meng at Bucknell University, and orthopedic surgeon Mr John Furia. The mobile app was developed by the students engaged in Mr Meng's computer science design project. Mr Meng said, "This was one of the times where the professor knew less than the students. He and the students pointed out that they learned a lot about the app-making process from each other. We came up with ideas that would cover what Dr Furia wanted to do, but also what we could or could not do." Heel Thy Tendon has been designed to study four regions on the foot and ankle that are usually affected. The areas are Achilles tendinopathy; planter fasciopathy; posterior tibial tendinopathy and peroneal tendinopathy. Depending on which area of the foot or ankle is giving problems, the individual can select the picture that represents the area. This is followed by a series of prompts that offers suggestions on the likely cause of the injury. The app also has a camera feature, the patient can take pictures and document the condition. The mobile application has been designed and developed to work on most smartphone platforms. Bucknell senior Mr Dana Germano said, "Dr Furia provided all of the documents for us to use, but it was up to us to arrange them in the way that they would be best viewed. We had to be knowledgeable with the material to be able to do that. We discovered there is so much to think about that you never worry about when you just open up an app."     ]]> https://biospectrumindia.com/features/97/4295/bi-biotech-india.html https://biospectrumindia.com/features/97/4295/bi-biotech-india.html Tue, 30 Nov -001 00:00:00 +0553 BI Biotech India a major distributor of biological researchreagents for the lifescience industry, has clocked a revenue of `31.11 crores for the last fiscal year. The company has earned creditability and has established itself into the lifescience research market, with itskey focus onto provide customers value added services which makes it a preferred vendor. With substantialincrease in revenue every year, the company has maintained its growth consistently. During the year, it has introduced cost effective DuoSet -5 plates (R&D Systems), molecular range of products in its portfolio from TIANGEN Biotech. The company has decided to absorb the shipping charges. The company represents some of the US based world renowned Canada, Major Science, Taiwan, IKA, Germany.As per company, a comprehensive range of products under its product portfolio, helps it to meet therequirements of scientists. The company believes that their customer service boosted its growth. Thefirm aims to provide cutting edge technologies from across the globe through strategic global partnershipswith giant firms like R&D systems, Tochris Biosciences, Boston Biochemand many others. In the long run, BI Biotech plans to extend sales network by enhancing services and establishing itself as animportant source for not only its key products but also for newly developed product alternatives. Moving ahead, the firm aims to achieve revenues of set `34.32 crores for the next fiscal year.   ]]> https://biospectrumindia.com/features/97/4296/biodigital.html https://biospectrumindia.com/features/97/4296/biodigital.html Tue, 30 Nov -001 00:00:00 +0553 Biodigital has emerged as one of the leading suppliers of equipment in the bioresearch market with prime focus in the field of biotechnology and other related fields. It has range of products, which offers directly to the end users in three market areas including the lifesciences, biotechnology markets, pharmaceuticals and healthcare. It represents well-known brandsin India such as Syngene, Martin Christ, Synbiosis, Biochrom and Sensi-Q for instruments such as FreezeDryers, Vacuum Concentrators, Freezers, Centrifuges, Autoclaves, Ice Machines, CO2 Incubators, TissueHomogenizers, Electrophoresis Systems; Elisa Readers, Spectrophotometers, Production scale FreezeDrying Machines, Cold Chain and Blood Chain Systems for storage and transportation of vaccines in the vast product portfolio of the company. It also maintains a good inventory of critical spares so that in the event of a breakdown and fault, the downtime of equipment is reduced to bare minimum. Biodigital has been concentrating on the excellent after sales service to its customers through a team of service engineers. The company touches base with almost all the leading institutions in India through its wide distribution network located in some of the strategic markets all over India. It has performed very well and generated a turnover of `30 crore in the FY14 as against `24 crore in the last fiscal year.   ]]> https://biospectrumindia.com/news/97/4489/indian-origin-researcher-developed-a-wearable-vapour-sensor.html https://biospectrumindia.com/news/97/4489/indian-origin-researcher-developed-a-wearable-vapour-sensor.html Tue, 30 Nov -001 00:00:00 +0553 Researchers at the University of Michigan including one of Indian-origin, are developing a new wearable vapour sensor that could offer continuous disease monitoring for patients with diabetes, high blood pressure, anemia or lung disease. The new sensor can detect airborne chemicals either exhaled or released through the skin. It would likely be the first wearable to pick up a broad array of chemical, rather than physical, attributes, researchers said. "Each of the diseases has its own biomarkers that the device would be able to sense. For diabetes, acetone is a marker, for example," said Mr Sherman Fan, a professor of biomedical engineering. Other chemicals it could detect include nitric oxide and oxygen, abnormal levels of which can point to conditions such as high blood pressure, anemia or lung disease. Mr Fan is developing the sensor with Mr Zhaohui Zhong, an associate professor of electrical and computer engineering, and Mr Girish Kulkarni, a doctoral candidate in electrical engineering. The researchers said their device is faster, smaller and more reliable than its counterparts, which today are much too big to be wearable. "Nanoelectronic sensors typically depend on detecting charge transfer between the sensor and a molecule in air or in solution," Mr Kulkarni said. "Instead of detecting molecular charge, we use a technique called heterodyne mixing, in which we look at the interaction between the dipoles associated with these molecules and the nanosensor at high frequencies," he added. This technique, made possible through the use of graphene, results in extremely fast response times of tenths of a second, as opposed to the tens or hundreds of seconds typical in existing technology. It also dramatically increases the device's sensitivity. The sensor can detect molecules in sample sizes at a ratio of several parts per billion.     ]]> https://biospectrumindia.com/features/97/4881/16-biogentek-bg.html https://biospectrumindia.com/features/97/4881/16-biogentek-bg.html Tue, 30 Nov -001 00:00:00 +0553 Biogentek represents the well-known international brands in the biotechnology instrumentation. The company is headquartered in New Delhi, and provide sales and support all over the country. It has a well-defined network of its own offices and personnel all over India. Principal companies represented by the company are KUHNER AG, Switzerland for shakers and incubator shakers, including shaking bioreactor(single use) up to the range of1000 liter, APPLIKON Biotechnology by Holland for bioreactors from micro to production scale; LABCONCOcorporation USA; LEEC Ltd,UK; NEXCELOM Biosciences USA;STATEBOURNE ,UK. With an employee turnover of around 50. The company was an exclusive biotech company, focused on laboratory research and pharma production. It is a partnership company and has recently finished 16 years in the industry. Recently the company has added new products such as Virus counter from Virocyt, USA and Photo Bioreactors(Flat) from PSI (Photon Systems Instruments),Czech Republic. The company's product portfolio includes lab incubators, incubator shakers, biotech lab equipment's like cabinet shaker, shaker rack system. It also deals with cell culture and plant physiology. The other products pertaining to the field include cultivation devices and fluroimaging flurometers. The company has recorded a revenue of Rs 28 crore in the FY14, as against Rs 29.5 crore in the previous year.   ]]> https://biospectrumindia.com/features/97/4885/17-trident-equipments.html https://biospectrumindia.com/features/97/4885/17-trident-equipments.html Tue, 30 Nov -001 00:00:00 +0553 Established in 1998, the company is a leading supplier of analytical equipments. The company distributes the instruments of major supplier company's like Thermo fisher, GE, Hellma etc Their product catalogue includes wide range of online analyzers like sodium, chloride analyzers, pH, Cond, DO, Chlorine, Turbidity Analyser manufactured by Thermo Orion and GE Analytical Instruments to address water and waste water applications. It is a reputed company in the field of analytical, process and lifescience instrumentation. Besides this, the company's service team carries onsite calibration and validation services for Deep Freezers, CO2 Incubators, Humidity Chambers, Air Samplers, pH Meters, Analysers etc. In the FY14, the company generated 24 crore as opposed to 18 crore in the previous fiscal year. The company eyes a growth of 20 percent for the next fiscal year, FY15. Trident recently announced that ithad secured distribution rights for Microfluidics, US, which would help the firm to tap the research and pharma markets.   ]]> https://biospectrumindia.com/features/97/4887/18-esco-biotech.html https://biospectrumindia.com/features/97/4887/18-esco-biotech.html Tue, 30 Nov -001 00:00:00 +0553 The ESCO Biotechnology Equipment Division is part of Esco Global group founded in 1978 and was an early pioneer in cleanroom and controlled environment technologies. This foundation enabled Esco to develop into the renowned life sciences equipment solutions provider it is today. Esco has emerged as a leader in the development of laboratory, medical and pharmaceutical equipment solutions. Products sold in more than 100 countries include biological safety cabinets, lab incubators and ovens, CO² incubators, fume hoods, ductless fume hoods, laminar flow cabinets, ultra-low temperature freezers, laboratory freezers and refrigerators, hospital pharmacy isolators, containment/pharmaceutical products, PCR cabinets, thermal cyclers, animal containment workstations, ART equipment and powder weighing balance enclosures. ESCO has the largest installed base of imported Bio Safety Cabinets in India with over 3,000 cabinets installed all over the country in different reputed Pharma Companies, Biotech Companies, Research Institutes, Universities and Educational Institutes. Under the Foundation for Innovative New Diagnostics (FIND) Project, the company received order for supply of Biological Safety Cabinets and Laminar Airflow Cabinets from United Nations Office for Project Services (UNOPS) for TB Hospitals recently. The company has won a major package order to supply various equipments in IVF - Medical segment from Bansal Hospital -Ayushman Medical Diagnostics Pvt Ltd, BhopalIn fact, the company is planning to focus on high value equipments and big projects and increase penetration in IVF segment in the yea2 1014-15. Esco focus on promoting products in chemical, petrochemical, automobile and allied industrial segments. Esco is recognized as a global player in containment, clean air and laboratory equipment technology. The company distributes its products to more than 100 countries - and a direct presence in 10 of the key global markets.   ]]> https://biospectrumindia.com/features/97/4889/19-permionics-membranes-.html https://biospectrumindia.com/features/97/4889/19-permionics-membranes-.html Tue, 30 Nov -001 00:00:00 +0553 Permionics is the first and the only company in India to indigenously manufacture reverse-osmosis (RO), ultra-filtration (UF), and nano-filtration (NF) membranes for various process specific applications. Established in 1976, it custom-designs and engineers complete membrane based systems from pilot to commercial scale to suit the specific requirements of petrochemical, biotech, biochemical, pharmaceutical, food and beverage, dairy, chemical and other sectors. It also pioneers in manufacturing membranes and technology for the application of water treatment, effluent recycling, sewage recycling, and special process applications. The company's revenue stood at Rs 18.11 crore for FY 2013-14. Today, the company boasts of having the most extensive range of membranes to suit any process parameters. The company has handled more than 2,500 installations for the last 30 years in India, UK, Syria, Jordan, Ethiopia, Kuwait, Vietnam, Pakistan, and Dubai. The company's UF, NF, and RO membranes can be integrated in various upstream and downstream processes for separation, concentration, purification or recovery of small molecules, peptides or proteins, making the processes more economical and productive with enhanced recoveries. The company currently employs 120 professionals. In the previous FY 2012-13, it touched revenue close to Rs 15.54 crore. Permionics is currently exploring R&D initiatives for developing new membranes as well as applications for solvent recovery, chemical or biochemical processes and water and waste segments. The focus is also on covering chromatographic separations (RP, NP, HIC, SMB) along with membranes providing complete solutions to clients. The company had since early 1980's installed membrane systems for product recovery from ML's and purification of solvents. This made it possible to constantly develop and install applications for the biotech and pharmaceutical sectors as well as main stream biotech applications such as fermentation broth clarification and concentration. The wide range of membranes with various cut offs are unique and help handle various types of applications for MF, UF, NF and RO processes. These factors majorly contributed towards its growth in the last fiscal. Permionics is also venturing into new initiatives in identifying and developing new applications for membranes, solving issues faced by various industries. New greener technology deploying membranes for soya, lignocelluloses biofuels, sugars processing, bran processing were also developed by the company and were taken to pilot scale successfully. It launched several new membranes and expanded its product recovery areas both for biotech, pharma. Better facilities for characterization of existing as well as new upcoming membranes were also developed. Going forward, it targets market expansion in other regions in India as well as internationally.In the future, it aims to foster the solvent recovery applications for infusion of economics ahead of distillation and evaporation routes for solvent recovery.The company believes that there is a need for new membrane processes that can replace conventional energy consuming processes viz. distillation, spray drying and extraction and provide better yields and recoveries.   ]]> https://biospectrumindia.com/features/97/4891/20-jh-bio-innovations.html https://biospectrumindia.com/features/97/4891/20-jh-bio-innovations.html Tue, 30 Nov -001 00:00:00 +0553 JH BIO Innovations has been in the bioscience business for 22 years. They are now a leading supplier of laboratory instruments and equipment for lifescience, pharmaceutical, molecular diagnostics, and food and environmental sectors. With head office in Bangalore and branch offices at Delhi, Hyderabad, Pune, and Chennai, it has other resident representatives at Dharwad, Chandigarh, Lucknow, and Kolkata. All other important and potential places are covered through sub distributors or channel partners. The company's product line includes full range of molecular spectroscopy products from Thermofisher Scientific with over 13 models of UV, VIS, UV-Vis spectrophotometers including micro and macro segments. The brands include NanoDrop, Evolution, Biomate, Spectronic, and Genesys. The list also includes fluorospectrometers, low voltage electron microscope from Delong, America and Confocal microscope from Yokogawa, Japan. Nano particle size analyzer and zetapotential system from CORDOUAN Technologies, France, automated cell counter and handheld flow cytometer from ORFLO, USA, filter-based multimode readers from molecular devices, USA, are the company's new additions to its innovative product range. The company promotes its products through 10 major national events every year which include seminars, conferences, and exhibitions. It also spends substantial money on digital marketing including website, search engine optimization, e-mail marketing, and advertisements. In its budget allocation for promotional activities, approximately 3 percent is allocated for annual sales. On the collaboration side, JH Bio Innovations bagged a major order from All India Institute of Medical Sciences (AIIMS) for setting up CSSD facility. In future, it expects to venture into medical instrumentation. The company's revenue for FY 2012-13 stood at Rs 12,60,000.   ]]> https://biospectrumindia.com/news/97/5098/biotime-appoints-new-board-of-directors.html https://biospectrumindia.com/news/97/5098/biotime-appoints-new-board-of-directors.html Tue, 30 Nov -001 00:00:00 +0553 BioTime has announced its new board of directors, Mr Michael H Mulroy and Mr Stephen L Cartt. Mr Mulroy has been appointed to the board to fill a vacancy and Mr Cartt has been nominated for election to the Board at the Company's upcoming annual shareholders' meeting. Mr Mulroy recently served as executive vice president, strategic affairs and general counsel of the autoimmune and rare diseases business unit, Mallinckrodt Pharmaceuticals. Mr Cartt has served as chief operating officer of the autoimmune and rare diseases business unit of Mallinckrodt. "We are very pleased that Mr Mike Mulroy and Mr Steve Cartt are joining our Board of Directors. Both of these executives have exceptional track records of creating substantial shareholder value over time. As BioTime and its subsidiaries move into clinical trials with several products, we are focused on adding biopharmaceutical industry executives to our management teams and boards of directors who have records of successfully advancing products through clinical trials and commercialisation while creating substantial shareholder value," commented Mr Michael D West, CEO, BioTime. "We look forward to working closely with both of them to build significant value for BioTime's shareholders over time," he added.   ]]> https://biospectrumindia.com/features/97/5261/13-bioscreen.html https://biospectrumindia.com/features/97/5261/13-bioscreen.html Tue, 30 Nov -001 00:00:00 +0553 Introducing a wide range of innovative products in the market. Bioscreen recorded 11.8 percent growth in 2013-14. With a pan India presence of eight branches across India, Bioscreen is a leader in offering automated liquid handling solutions for the lifescience and drug discovery markets. Through its various initiatives, Bioscreen is steadily becoming stronger in the biotech market. The firm established itself in the market in partnership with Tecan, through the Tecan automated liquid handling and microplate multimode detection system that served various applications. Riding high on the innovation wave, the firm introduced a wide range of novel products that catered to the needs of all major disciplines of lifesciences, in the last fiscal year. The firm's LGC K Bioscience KASPA Genotyping Technology helped the firm tap the emerging clinical and agro market. Other examples of product augmentation were introduction of microflow imaging for protein aggregation, automated Weston analyzers for biomarker validation, high throughput colony picking system used at molecular biology labs and automated evaporation system for controlled crystallization applications. The firm's new bio banking automated storage system that provides temperature regulated storage for biological samples attracted global pharma players and many research laboratories. Bioscreen's major collaborations with the National Center for Biological Science, Bangalore and Indian Institute of Science and Educational research, Chandigarh played an instrumental role in designing and developing innovative products to leverage the market. ]]> https://biospectrumindia.com/news/97/5296/-cole-parmer-expands-its-digi-sense-product-range.html https://biospectrumindia.com/news/97/5296/-cole-parmer-expands-its-digi-sense-product-range.html Tue, 30 Nov -001 00:00:00 +0553 Cole-Parmer has expanded its Digi-Sense line of precision measurement instruments. Digi-Sense has introduced several new instruments for convenient temperature measurement, equipment testing, and inspection. The "Be Sense-ible" line from Cole-Parmer contains a full range of environmental and temperature instruments that includes thermocouple meters, thermistor meters, RTD meters and infrared thermometers-many with NIST-traceable calibration already completed and ready to use upon arrival. The new items include, Digi-Sense Precalibrated Humidity and Temperature Indicator monitors humidity levels and displays temperature and time as well. The Indicator contains a unique environmental comfort indicator; Digi-Sense Precalibrated Pocket Thermometers in large head, pen style, and folding probe types take fast and accurate temperature measurements anywhere; Digi-Sense Precalibrated Pocket-Size Moisture Meter measures the moisture level in wood products and hardened materials with one-handed operation; Digi-Sense Precalibrated Digital Contact/Photo Tachometer ensures equipment is in optimal operating condition, eliminating costly repairs; and Digi-Sense Borescope and Video Borescope are ideal for inspecting ductwork, wiring, piping, vehicles, and other hard-to-reach areas.     ]]> https://biospectrumindia.com/news/97/5529/philips-shareholders-approve-lighting-biz-separation.html https://biospectrumindia.com/news/97/5529/philips-shareholders-approve-lighting-biz-separation.html Tue, 30 Nov -001 00:00:00 +0553 Following the vote in Amsterdam, Royal Philips said that it will continue the process to set up two market-leading independent companies that will focus on the vast opportunities in health technology and lighting solutions. "We welcome the decision by the AGM to approve the separation of our Lighting business from Royal Philips and I fully appreciate the historic significance of today's meeting," said Mr Frans van Houten, Philips' CEO. "Both our multi-billion euro healthtech and lighting solutions businesses have the right fundamentals for profitable growth in their fields." The transition of the lighting business into a separate legal structure will take at least until the end of 2015, in order to be ready for the separation, which is currently intended to be effectuated through an IPO in the first half of 2016. At the same time, alternatives will continue to be carefully reviewed. The AGM also approved the proposal to re-appoint Mr Frans van Houten, Mr Ron Wirahadiraksa and Mr Pieter Nota as members. ]]> https://biospectrumindia.com/news/97/5644/pall-corporation-increases-quarterly-dividend.html https://biospectrumindia.com/news/97/5644/pall-corporation-increases-quarterly-dividend.html Tue, 30 Nov -001 00:00:00 +0553 Pall Corporation has announced that its board of directors declared a nearly 11 percent increase in the company's quarterly dividend from the current rate of $0.275 to $0.305 per share. The dividend of $0.305 is payable on November 10, 2014 to shareholders of record on the close of business on October 20, 2014.   ]]> https://biospectrumindia.com/news/97/6214/first-ever-hearing-app-launched-in-india.html https://biospectrumindia.com/news/97/6214/first-ever-hearing-app-launched-in-india.html Tue, 30 Nov -001 00:00:00 +0553 Quadio Devices, a leading hearing care provider of India, introduced for the first time their path breaking Q+ hearing app in Mumbai on android and iOS platforms. The app promises to be a holistic mobile-based hearing solution complete with all the features of a conventional hearing tool. The Q+ app is a first of its kind free application that is ultra-advanced besides being affordable, accessible, controllable and customizable. Quadio uses the latest internet and mobile technology to push the boundaries of telemedicine and hearing care and merge the worlds of healthcare and technology. The Q+ app harnesses the processing power of your smart phone to enable it to be used as a complete and fully-functional hearing mechanism. It is designed to maximize the listening experience based on the results of a simple interactive hearing test.   The app also gives you the ability to control and customize sound quality by intelligently enhancing hearing sounds and speech. With the Q+ app you can easily follow conversations using the phone headset in both quiet and noisy environments, and control the sound quality to customize it to your preference. The inbuilt hearing test in Q+ is calibrated for accuracy as per ANSI standards for audiometry. Mr Neeraj Dotel, CEO, Quadio Devices said, "Hearing loss is the second largest disability in the country that affects more than 120 million lives with majority sufferers over the age of 60. There are less than 2000 practicing audiologists in India and therefore most people have never actually received treatment until their hearing has degraded severely with age. The Q+ app is a stellar example of the innovative capabilities of Quadio where our customers don't have to shell out big bucks for hearing care and anyone with a smartphone can now have access to high-quality hearing mechanism." Headquartered in Pune, Quadio was founded by two IIT graduates in 2009 by Mr Paresh Patel from IIT Kanpur and Mr Anurag Sharma, a silver medallist from IIT Bombay with a vision to deliver innovative hearing solutions to anyone, anytime, anywhere, and empower individuals to hear what they want, how they want and when they want. Mr Anurag Sharma, Co-Founder and CTO Quadio Devices Pvt Ltd, said: ".....The flexibility of controls offered by a smartphone app is much more than that offered by conventional hearing aids and, along with the affordability of smartphones, the reach of app store, and the inbuilt test, this gets us closer to achieving our objective. I appreciate the hard work put in by our team in creating a wonderful amalgam of technology, intuitive design and stellar performance into a package that is Q+." ]]> https://biospectrumindia.com/news/97/6391/sgs-life-science-to-open-lab-in-mumbai-soon.html https://biospectrumindia.com/news/97/6391/sgs-life-science-to-open-lab-in-mumbai-soon.html Tue, 30 Nov -001 00:00:00 +0553 SGS Life Science Services has announced the completion of a major expansion at its Mumbai facility with validation of new equipment currently underway. An official opening of this state-of-the-art laboratory is planned for May 20, 2015. The expansion has seen the previous 1,393 square meter laboratory space more than double in size, to 3,400 square meters, and, once validation is completed, the laboratory will act as a dedicated cGMP pharmaceutical testing site. The workforce has increased from 65 to 115, with the potential for up to another 40 employees in the additional facilities. Investment at the laboratory has been focused on increasing stability chamber capacity, and in supporting chromatography equipment, including new UPLC capabilities. The Mumbai facility now has the largest stability testing facility in the SGS Life Science Services' global network, with the expansion driven by the increased demand from both local and international customers. Three new 100 cubic meter capacity stability chambers have been installed for 21 CFR part 11-compliant short term, long term and accelerated studies, and covers all the International Conference of Harmonisation (ICH) conditions, as well as flexibility for specific client conditions. The Mumbai expansion follows SGS's renovation of its Chennai, India, laboratory in 2014, increasing laboratory space within the facility. The number of employees increased from 60 to 75, with the flexibility to further accomodate up to 90. "India is strategically very important for SGS Life Science Services, and the investments we have made in both Mumbai and Chennai have been based on customer demand for dedicated Full Time Equivalent-based models. These two facilities, coupled with our facility in Singapore, work very much as a harmonized unit, supporting not only local clients, but those across South East Asia and beyond," said Mr Paul House, managing director, SGS India.   With 19 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I to IV clinical trial management and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.     ]]> https://biospectrumindia.com/news/97/8312/disrupting-global-surgical-care-industry.html https://biospectrumindia.com/news/97/8312/disrupting-global-surgical-care-industry.html Tue, 30 Nov -001 00:00:00 +0553 The emphasis will be on affordable technology for early diagnosis; portable modular equipment for minimally invasive and robotic surgery; and smart systems incorporating low-cost sensors and mobile technology to track clinical outcomes and improve team-based surgery. The report summarizes the findings of a workshop held in Boston earlier this year by product design and development firm Cambridge Consultants. It offers unique insight into the future of emerging markets surgical care - as seen through the eyes of industry leaders. It looks at how these new approaches to healthcare will extend beyond emerging markets to disrupt and transform how affordable quality surgical care is delivered globally. "More than 85% of the world's population live in emerging markets, yet many of these people have no access to affordable quality healthcare, particularly complex treatments like surgery," said Mr Rahul Sathe, head of surgical innovation for emerging markets, Cambridge Consultants. "Inadequate hospital infrastructure, scarcity of qualified clinicians and fragmented healthcare ecosystems prevent successful surgical care. The surgical device industry has unprecedented growth opportunity to address the unmet needs of very large patient populations."   The report spells out the huge opportunities for technology disruption in emerging markets. Infrastructure and regulations are still being formed, and industry legacy is not particularly strong - offering a lower barrier to innovation compared with developed markets. The primary role of technology will be twofold, says the report. It can extend the 'hospital ecosystem' across the continuum of care from early diagnosis and surgical intervention to post-operative monitoring. It can also ensure products and solutions are robust, usable and affordable - and unlock access to care.   The workshop delegates predicted that patient expectations and hospital ecosystems in emerging markets will dramatically evolve and, in some cases, leapfrog developed markets. Even today, some hospitals in India have better outcomes for cardiac surgery than top hospitals in the US or UK. And top-tier hospitals in China are now being designed to be eco-friendly, sensor-rich and cloud-connected. See Also: Cambridge Consultants develop smartphone operated insulin injection pen "Emerging markets will play a significant role in transforming our industry," said workshop delegate Mr Agustin Zabulanes, Latin America marketing manager, Boston Scientific. "Local emerging market companies may provide stiff competition to multinational companies - but they may also prove to be powerful partners in global surgical care. Success will require industry players to evolve the way they do business, organize for innovation and use enabling technology." The report says 'reverse innovation' offers developed markets the opportunity to benefit from emerging markets by learning new approaches to achieving healthcare affordability and efficiency - with lasting transformation coming from integrating new business models and innovation models.   "As organizations evolve and succeed, innovating for emerging markets will enable industry to disrupt and transform how surgical care is delivered globally," said Mr Sathe.   ]]>