Covid-19 Test Kit
We are very pleased to announce that CoViDx One, GenePath Diagnostics' indigenously developed Covid-19 RT-PCR test kit, is now available for sale in India. 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 is 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.
Top 5 reasons you should switch to the GenePath CoViDx One kit and make it the assay of choice for distribution [your lab]:
- Single tube assay → maximize your lab’s throughput
- 3 target genes → increase confidence in your diagnosis
- Contains an endogenous human control gene → ensures proper process control through sample prep
- PCR cycle time of less than 90 minutes → faster TAT
- Excellent clinical sensitivity à our assay is now being used by CLIA labs in the US
Dr. Nickhil Jakatdar, our CEO, recently 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.”
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.
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.