Innovation with global impact
Diagnostic for HIV management
![Product of the year](/IMG/899/45899/productoftheyear.jpg)
Bangalore-based
ReaMetrix
believes in innovating affordable solutions, to address the diagnostic
needs of a developing nation within the challenges of the local
environment.
Innovation-centered ReaMetrix has developed the ‘Dry Tri-T
STAT’ product used in HIV management, for the global market.
This is said to be the only Food and Drug Administration (FDA) cleared
dried-down CD4 enumeration product available in the world today for the
flow cytometry instrumentation market. The other companies that
manufacture similar products are Becton Dickinson, Beckman Coulter and
Guava Technologies but they all use liquid reagents.
Germany’s Partic has recently launched a product based on dry
formula but it is not FDA approved.
The unitized, dried-down delivery format from ReaMetrix’ Dry
Tri-T STAT eliminates the need for refrigeration, exhibits nearly 99
percent correlation with conventional liquid format. Its pre-dispensed
product tubes enable a simplified workflow, assuring highest accuracy
and reliability. This test is being made available at less than
one-third of the cost of the existing, imported liquid-format reagent
product.
Expressing delight that a company in India has treaded a new,
commendable path impacting the global medical diagnostics industry, Dr
Bala Manian, CEO, ReaMetrix, says, “ReaMetrix is proud to
have pioneered a revolution in global diagnostics. At ReaMetrix, we
believe in inverting the conventional thinking by solving the
diagnostic needs in the developing nation and then deploying these
solutions globally. The ‘dried-down’ innovation is
a successful validation of our thinking, as this is an innovation that
is set to have a global impact.”
The product potential
According to National AIDS Control Organization (NACO) estimates,
national adult HIV prevalence in India is approximately 0.36 percent of
total population, that is nearly 2.5 million people. Currently, there
are 197 government anti-retroviral therapy (ART) centers and some
private ART clinics, spread across India where CD4 testing is
available. Access to reliable, accurate and affordable CD4 testing
solutions, is key in the clinical management of HIV patients.
Some of the predominant issues with CD4 testing in India are, the high
cost of testing, poor access to testing, poorly developed cold chain
for the transport, storage and use of products, complicated work flow,
and a demand for skilled labor. The real challenge lies in transporting
blood samples from remote areas to centralized testing centers. In most
cases, this leads to ‘aged’ blood samples (>
48 hours), making it unusable for testing. ReaMetrix’s
innovative dried-down CD4 enumeration product helps address this need.
With the unitized dried down products, the cost of the CD4 enumeration
test per patient will see nearly a four-fold reduction in costs, while
at the same time producing accurate diagnosis. Blood can be collected,
stained and fixed at the point of collection before being shipped to a
central testing facility at room temperature. The stained samples can
be stored for up to seven to 10 days at room temperate eliminating the
issue of ‘aged’ blood samples.
The ReaMetrix’s HIV dried-down product enables doctors to
derive quality diagnostic information at an affordable price. This
translates to lower cost of testing for the patient. Since there is no
need for cold chain for use of these products, diagnostic laboratories
will be able to access samples from far-off locations, enabling better
cost-efficiencies on their centralized and capital-intensive
equipments. From a public health perspective, the affordability will
enable frequent testing which in turn will enable doctor to take
treatment decisions based on trends rather than on just a single test
result.
Key Features of
Tri Dry-T STAT
- Decentralization of sample collection: Collect
samples at a remote center before shipment to a central laboratory.
- Stability: Dried-down reagent does not require cold
storage. Fixed and stained samples can be stored for up to seven days
prior to analysis.
- No cold chain: No refrigeration capabilities needed
at point of blood collection.
- Accuracy and reproducibility: Dry Tri T-STAT reagents
have been evaluated at multiple laboratories in India as well as by
leading international labs. Dry Tri T-STAT reagents have demonstrated
robust equivalence to industry standard reagent kits.
- Simple sample workflow: Reagents employ simple
protocol of lyse/ no-wash or no-lyse/ no-wash protocol. Mix the sample
and analyze.
- One world, one quality: Dry Tri T-STAT is the only
FDA cleared dried-down CD4 enumeration product available globally.
- Affordability: At least one-third of the price of
equivalent products available in the market.
What next?
The next step is to make the product accessible in all the developing
and under-developed countries. Although, the product is FDA approved,
ReaMetrix is not looking at marketing the product in the developed
nations right now as the product Dry Tri-T STAT was developed
with the aim of serving the developing and underdeveloped countries
first. Shares Dr Sridhar Ramanathan, executive director, ReaMetrix,
“Unless blessed in the West, a product is not well received
in the local market. FDA was just an external validation for the
product.” ReaMetrix is aggressively focusing on South Africa
where more than 2,50,000 HIV tests are done per month.
The company has set a target of six million tests per year globally
from its 20,000 sq.ft. Bangalore facility and is looking at extending
the drying technology to other diagnostic applications. Being a venture
capital (VC) driven company, Dr Ramanathan was not willing to divulge
the company’s revenue and the investment value that has gone
in towards developing the Dry Tri T-STAT.
ReaMetrix’ product focus is to develop many such medical
diagnostic solutions from a global perspective. The company intends to
use the ‘Indian opportunity’ as an incubation
center for the development of products with an international niche.
Says Gokul Srinivasan, director, product development, ReaMetrix,
“We have the unique capability to address local markets with
local resources and a local viewpoint. This gives us a strong
competitive edge against western companies who attempt to import
technology into the developing world, or simply use developing nations
as sources of low cost labor. We believe that a local stake in the
outcome is absolutely necessary to assure economic
sustainability.”
Driven by the ‘Think Local, Act Global’ paradigm,
ReaMetrix is powered by a cross disciplinary team of engineers,
chemists, biologists and doctors, and offers innovative solutions in
the field of medical diagnostics. The company portfolio of products
currently includes products for monitoring HIV progression, stem cell
enumeration, screening patients for ankylosing spondylosis and staging
cancer patients.
Jahanara Parveen in Bangalore