Gautam Wankhede , Director Medical Affairs, Mylab Discovery Solutions
Recently, the Central Drugs Standard Control Organisation (CDSCO) gave commercial approval to Mylab Discovery Solutions’ Made in India COVID 19 test kits. According to the Pune-based molecular diagnostics startup Mylab, the kit named as Mylab PathoDetect COVID-19 Qualitative PCR kit is the first one to receive commercial approval from the national regulatory body.
Read our special interaction with the Mylab on how they achieved it and many other aspects:
How could you achieve to become the first one to manufacture a testing kit for COVID 19 in India?
Research and manufacturing high-quality diagnostics has always been our focus. We have been in space for several years now. We are the only Indian company with ID-NAT test approval in India. Looking at how the novel coronavirus was spreading across the world, our research team started working on developing tests ~6 weeks ago (before the approval date). The experience of the team in developing such tests has been a great help in developing this kit as per the WHO standards.
What is the current manufacturing capacity of Mylab for COVID test kits ?
As of the last week, our manufacturing capacity is 20,000 tests per day. Each test kt can test 100 samples. We are working to ramp up our capacity already. The kit will screen and detect COVID-19 infection within two-and-a-half hours, which is quite less compared to more than the hours taken by current testing infrastructure.
How the tests kits by Mylab are economical solutions over currently available test kits in the global market ?
Our price is 1/3 to ¼ of the ICMR price cap. So, we think it is a cost-effective solution.
Could you explain to our readers how does the testing kit works ?
It is based on the extraction of the genetic material of the virus from the sample and then using PCR to polymerize it and make several copies and then identifying its the basis of genetic signatures. There are about 5000 such instruments available across various labs in India. While some of the instruments might be in research lab services that are not involved in patient diagnostics, a substantial amount of these instruments are already present in labs across the country. This is the only instrument required to use the test kit.
Are you doing any further R & D to improvise more on the current testing kit developed by Mylab ?
We are constantly looking for ways to make the tests more efficient and accurate and the test available from Mylabs is already saving 65% time and has 100% concordance in ICMR evaluation.
Director of Medical Affairs
Mylab Discovery Solutions