Made-in-India COVID-19 test kit by Mylab gets commercial approval.

Mylab Discovery Solutions Pvt Ltd, a molecular diagnostics company specializing in molecular testing kits, has established the first COVID-19 made-in-India research kit within a record span of six weeks. The set— Mylab PathoDetect COVID-19 Qualitative PCR Package— is the first to receive a regulatory license from the CDSCO (Indian FDA). Moreover, Mylab Discovery Solutions Pvt Ltd is the only Indian organization that has attained 100% sensitivity and precision in the ICMR evaluation.

"The COVID-19 kit has been created under the Guidance of WHO / CDC, with focus on Make in India and funding from the local and central government. It has been developed and tested in record time," said Hasmukh Rawal, Managing Director, Mylab Discovery Solutions. Shailendra Kawade further said that the assistance and prompt intervention of regulatory bodies (CDSCO / FDA), the ICMR evaluation center, the NIV, the BIRAC and central and state governments during these national emergencies is commendable.

Mylab has a long tradition in the production of RTPCR kits. It manufactures a variety of kits at Indian FDA / CDSCO licensed facilities and complies with the MDR 2017 legislation for the manufacture of Class C and D medical devices, the strictest and highly limited government goods. Mylab currently manufactures ID-NAT test kits for blood banks/hospitals, HIV, HBV, and HCV kits. Mylab has obtained clearance for the manufacture of the COVID-19 Qualitative Kit in the same facility from the Drugs Controller General of India (DCGI).

The package of Mylab COVID-19 was tested at the Indian Council of Medical Research (ICMR). "We tried hard to make state-of-the-art technologies accessible for our country at a fair and inexpensive price. As this test is focused on the responsive PCR technologies, even early-stage infections with optimum accuracy can be detected during ICMR tests.

Currently, India ranks the lowest per million population in terms of research. The number is as low as 6.8. Countries like South Korea and Singapore have expanded their research capability to handle the increasing number of Coronavirus cases.

So far the Indian government has provided millions of German research kits for the monitoring of PAN-India Coronavirus patients. Nevertheless, the reliance on international kits has been problematic and the supply of grounded airlines is being blocked. This will change with the authorization of kits manufactured in India.

Mylab agreed to generate up to 1 lakh tests in a week which can be extended further if appropriate. Furthermore, the test sets will test about 100 patients in one kit. The firm says. More than 1000 patients will be checked per day in a normal PCR laboratory.

This would be a milestone for India with the local manufacturing of test kits as the Mylab test kit will cost about a quarter of the existing production costs. In comparison, Mylab PathoDetect COVID-19 Screens and detects the virus in a high performing PCR package within 2.5 hours, in contrast to the seven hours of existing protocols. It means that laboratories will handle twice as many on one system at the same time.

The Mylab plant, which was approved by the FDA / CDSCO, is compliant with the MDR 2017 Class A, B, C and D medical device manufacturing legislation and ISO 13485: 2016 approval.

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