Pune-based molecular diagnostic company to develop COVID-19 testing kits

Published : March 28, 2020 21:22 IST

The newly inaugurated Virus Research and Diagnostic Laboratory and testing facility for COVID-19 at Bangalore Medical College and Research Institute (BMCRI) in Bengaluru. Photo: K. MURALI KUMAR

Mylab Discovery Solutions Ltd, a Pune-based molecular diagnostic company, has been given commercial approval by the Food and Drug Authority (FDA) and the Central Drug Standard Control Authority (CDSCA) to manufacture what is called the Mylab PathoDetect COVID-19 qualitative PCR (Polymerace chain reaction) kit. Mylab got the go-ahead on March 23 and began supplying kits to government and private labs from March 26, said a company executive to Frontline.

In an official release Mylab said it would keep the price point affordable would not look at it as a commercial venture. The company said the price of the testing kit was nearly one-third of the price cap set by the Indian Council for Medical Research (ICMR). The manufacturing unit is able to produce 200 kits a day, which means 20,000 tests can be done per day.

Mylab Discovery Solutions would be one of two private Indian companies to get clearance from the FDA, the CDSCA and the ICMR to make testing kits for the SARS-CoV-2 virus. Mylab said it developed the kit in six weeks.

Reports say that India has been sourcing the kits from Germany and the United States but the imports were not enough to meet the demand. Reports say that currently, India ranks very low in terms of testing done per million population. The number is as low as 6.8 per million. Countries like South Korea and Singapore have been able to contain the growing number of COVID-19 cases by testing more and more people.

A statement from ICMR says, “Test kits with 100 per cent concordance among true positive and true negative samples will be approved for commercial use in India.” Mylab achieved 100 per cent sensitivity and 100 per cent specificity in the ICMR evaluation.

“At present, Mylab can produce kits to test for 20,000 samples per day. However, in case of an adverse situation, the company can ramp up its capacity to ship kits to conduct 50,000 tests per day,” said Rahul Patil, Executive Director and Operations head, Mylab Discovery Solutions. Furthermore, the company says the Mylab PathoDetect COVID-10 Qualitative PCR kit screens and detects the infection within two and a half hours, compared to the seven hours taken by current protocols.

The Mylab manufacturing facility, approved by FDA/CDSCO is complaint with MDR 2017 regulations for Manufacturing Medical Device of Class A,B,C and D and ISO 13485: 2016 certification. Mylab currently manufactures ID-NAT screening kits for blood banks/hospitals.