Pune-based Mylab gets commercial approval for COVID-19 test kit

First ‘Made in India’ COVID-19 tests kit gets commercial approval from CDSCO; to cost nearly one-fourth of the currently procured kits.

As India fights back the epidemic COVID-19 (aka Coronavirus), limited testing facilities and expensive testing kits has become the biggest concern for the authorities. In order to combat this challenge, the Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd which specialises in molecular diagnostic kits has developed the first made in India test kits for COVID-19 in a record time of six weeks. The kit is the first one to receive commercial approval from Indian FDA/Central Drugs Standard Control Organisation (CDSCO) and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit. Further, according to the company, Mylab is the only Indian company to have achieved 100 per cent sensitivity and 100 per cent specificity in the ICMR evaluation.

“We have been trying hard to make cutting-edge technology available to our country at a reasonable and affordable price. Since this test is based on the sensitive PCR technology, even early stage infection can be detected, with highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too,” said Shailendra Kawade, Executive Director at Mylab.

Currently India ranks lowest in terms of testing done per million population. The number is as low as 6.8. Countries like South Korea and Singapore have been able to contain the growing number of Coronavirus cases by doing more and more testing.

So far, the Indian government is sourcing millions of testing kits from Germany to facilitate testing to diagnose Coronavirus patients PAN India. However, the dependency on foreign kits has been troublesome and supply is getting blocked due to grounded airlines. This can change with the approval for made in India kits.

Mylab promised that it can manufacture up to 1 lakh tests in a week which can be further scaled up if needed. Further, the company claims that its test kits can test about 100 patients with one kit. An average lab with automated PCR can test more than 1,000 patients a day.

“With local sourcing of test kits, it will be a major breakthrough for India as the testing kit by Mylab would cost nearly one fourth of the current procurement cost. Moreover, Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to over 7 hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions in the same time on one machine,” a statement issued by the company said.