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.