‘CoViDx One’, the COVID-19 RT-PCR (Reverse Transcriptase-Polymerase Chain Reaction) test kit developed by Pune-based GenePath Diagnostics, has received approval for manufacture and sale in India from the Central Drugs Standard Control Organisation (CDSCO).
The approval was received on August 31, said a statement by the firm on Friday. The CDSCO has given approval to the Bengaluru-based Achira Labs to manufacture the kits.
The kit was validated by the Council of Scientific and Industrial Research’s Centre for Cellular and Molecular Biology (CSIR-CCMB) in Hyderabad and approved by the Indian Council for Medical Research (ICMR) earlier in the year. GenePath’s Pune clinical laboratory had earlier received approval from the National Accreditation Board of Laboratories (NABL) and the ICMR to carry out COVID-19 RT-PCR based testing in the country.
This makes GenePath the first company in India to run an NABL-ICMR approved COVID-19 testing lab as well as to have received approval to manufacture its own RT-PCR test kit.
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Dr. Nickhil Jakatdar, chief executive officer, 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 by utilising our expertise in molecular diagnostics over the last decade and with an investment of ₹50 crore into this effort”.
GenePath Diagnostics is a next-generation diagnostics company that operates Research and Development (R&D) facilities in Pune and at Michigan, U.S., as well as a state of the art clinical diagnostics facility in the city.
Dr. Jakatdar said the company had tested its kit for ‘clinical sensitivity’ in labs across India as well as the United States. “The kits have shown excellent results when compared with the best FDA [Food and Drug Administration] approved kits in the U.S. Importantly, we have managed to keep costs low owing to local manufacturing,” he said.
GenePath’s clinical lab has processed more than 20,000 COVID-19 tests for patients in Pune, one of the worst-affected cities in the country.
“We are happy to offer our RT–PCR tests at a much more affordable price point of just ₹1,500 per test at our [GenePath’s] drive-up facility in the city’s Wakdewadi area. This is much lower than the ₹2,200 per test mandated by the Maharashtra government. Likewise, with regards home collections, our test kit has allowed us to drop our price from the government-mandated ₹2,500 per test to ₹2,200. Our hope is that the usage of our test kit will enable many more labs to drop their prices without compromising on the quality of their results,” said Dr. Jakatdar.
Dr. Nikhil Phadke, founder and chief scientific officer, GenePath Diagnostics, said the company’s objective had been to create the “gold standard” of RT-PCR kits globally.
Published - September 04, 2020 10:34 pm IST
