Pune based GenePath Diagnostics makes its world class RT–PCR Test Kits available in India
Pune, September 4: CoViDx One, GenePath Diagnostics’ indigenously developed Covid-19 RT-PCR test kit, received approval for manufacture and sale in India from the Central Drugs Standard Control Organization (CDSCO) on August 31, 2020. The kit was validated by the Council of Scientific and Industrial Research’s Center for Cellular and Molecular Biology (CSIR-CCMB) in Hyderabad and approved by the Indian Council for Medical Research (ICMR) earlier in the year. The CDSCO has given approval to Bengaluru based Achira Labs, GenePath’s manufacturing partner, to manufacture the kit.
GenePath Diagnostics is a next-generation diagnostics company that operates R&D facilities in Pune and Ann Arbor, Michigan as well as a state of the art clinical diagnostics facility in Pune. GenePath’s Pune clinical laboratory had previously received approval from the National Accreditation Board of Laboratories (NABL) and the ICMR to carry out Covid-19 RT-PCR based testing in India. This makes GenePath the first organization in India to both run an NABL/ICMR approved Covid-19 testing lab as well as have received approval for its own world class Covid-19 RT-PCR test kit.
Dr. Nickhil Jakatdar, CEO, GenePath Diagnostics said, “As a kit manufacturer, our goal is to support every lab that wants to offer high quality tests at the lowest possible price, in order to make RT-PCR based testing more accessible and affordable to the common person. With that in mind, we went about developing our Covid-19 test kit in India, using our expertise in molecular diagnostics over the last 10 years and with an investment north of Rs. 50 crores into this effort. We have now tested our kit for clinical sensitivity in labs across India and the US and have shown excellent results when compared to the best FDA approved kits in the US, all the while keeping the costs low due to local manufacturing.”
“In addition to being a kit manufacturer, we also run a clinical lab that has processed more than 20,000 Covid-19 tests for patients in Pune. We are happy to announce that the innovations incorporated into our own test kit enable us to offer our RT – PCR tests at a much more affordable price point of just Rs.1500/- per test at our drive-up facility at Safire Galleria in Wakdewadi. This is much lower than the Rs.2200/- mandated by the Government of Maharashtra. Similarly, for home collections, the move to our test kit has allowed us to drop our price from the government mandated Rs. 2,500 to Rs. 2,200. Our hope is that the usage of our test kit will enable many more labs to drop their prices without compromising quality of results.”, he added.
Dr. Nikhil Phadke, Founder and Chief Scientific Officer of GenePath Diagnostics said, “This development is a significant landmark in our mission to improve human life by building and deploying high quality, accessible and affordable screening and diagnostic solutions for infectious diseases, cancers and genetic disorders. Our goal has been to create the gold standard of RT-PCR kits globally. In fact, our test kit design is already being used by leading edge labs in the USA. Now we hope that the manufacturing license for our kit will help to turn the health and economic situation around in India.”
“Being a clinical lab ourselves, we understand the challenges and constraints faced by labs when deciding the right kit to use. We developed the test kit with the goal being simplicity, convenience and cost to the lab. Our test kit is a single tube assay to maximize lab throughput capacity. We use 3 target genes and a human gene as our internal control, in order to ensure a very robust and accurate test. We have tested our kit on more than 4,000 clinical samples to ensure the highest level of clinical sensitivity, which means we minimize the chances of false positives and false negatives. Our PCR cycle run is amongst the fastest in the industry, thereby reducing the turn-around time from sample collection to results”, he added.
According to Dr. Jakatdar, GenePath is working very closely with a high-end lab (CLIA-accredited) in the US which has begun using the GenePath designed test kit on clinical samples and has applied to the US FDA for an EUA license. To support GenePath’s international expansion, it has engaged a manufacturing partner in the US which will produce GenePath branded Covid-19 test kits for the global market.
