Mylab gets commercial approval for the First Made-in-India COVID-19 Test Kit

There was a dire need for the testing kits amid Corona Virus pandemic in India. The Indian government is sourcing millions of Covid-19 testing kits from Germany. Since Germany is also fighting the Corona Virus and the airlines are grounded the supply of kits is also getting blocked. Certainly, the made-in-India kit will help the government to overcome the trouble and dependency for the Covid-19 testing kits.

Mylab PathoDetect COVID-19 Qualitative PCR Kit

Mylab Discovery Solutions Pvt Ltd, a Pune based molecular diagnostic company has developed the first Made-in-India test kit for Covid-19. The company which specialises in molecular diagnostic kits did this job in just six weeks. The company has named this kit -Mylab PathoDetect COVID-19 Qualitative PCR kit.

The kit has received commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO).

"With emphasis on Make in India and support from local and central government, the COVID- 19 kit has been made as per WHO/CDC guidelines. It was developed and evaluated in record time," Hasmukh Rawal, Managing Director, Mylab Discovery Solutions.

Mylabs is not a new player in the industry. In fact, it has several years of experience in making RTPCR kits. Mylabs boasts of a state of the art facility approved by Indian FDA/CDSCO and is compliant with MDR 2017 regulation for manufacturing medical devices.

In this facility, the company is already manufacturing ID-NAT screening kits for blood banks/hospitals.

The Drugs Controller General of India (DCGI) has given clearance to Mylabs to manufacture the COVID-19 Qualitative kit, in the same facility.

The Indian Council of Medical Research (ICMR) has also evaluated the Covid-19 kit made by Mylabs. Therefore there is no doubt about the quality of this product,

MyLab Kit's Results within 2.5 hours

According to Shailendra Kawade, Executive Director at Mylab, Mylab kit can even detect the early-stage infection with the highest accuracy. This was observed during tests at ICMR.

Mylab claims that they can manufacture up to 1 lakh kits in a week. One kit can test about 100 patients. The Made in India kit would cost nearly one-fourth of the current procurement cost.
Above all the desi kit is that it will detect the infection within 2.5 hours with complete accuracy. The existing kits take around 7 to 8 hours to give results. As a result, more number of cases can be tested now if the virus spreads further.

Mylab Discovery Solutions Pvt Ltd, 

Mylab, founded in 2016, describes itself as a "young and dynamic biotechnology company that develops and commercialises molecular diagnostic detection kits."

The company which already has over 150 products also has a portfolio of products for testing genetic disorders, called 'DiscoverSeries'.


''Mylab PathoDetect COVID-19 Qualitative PCR, is a result of continuous hard work and dedication by a team of 25 scientists. They have been working meticulously for the past six weeks told a company executive.