Mylab's first COVID-19 Made-in-India Test Kit gets commercial approval

Published Date | 2020 March 26

The Indian government has so far acquired millions of test kits from Germany to enhance the diagnosis of PAN-India Coronavirus patients

Mylab Discovery SolutionsPvt Ltd, a Pune-based molecular diagnostics company that specializes in molecular diagnostic kits, created the first made-in-India COVID-19 test kit in a record period of six weeks. The kit— Mylab PathoDetect COVID-19 Qualitative PCR kit— is the first to obtain commercial clearance from the Indian FDA / CDSCO. In addition, Mylab is the only Indian company to achieve 100% sensitivity and specificity in the ICMR assessment.

Hasmukh Rawal, Managing Director, Mylab Discovery Solutions said the COVID-19 kit was made in compliance with the guidelines of the WHO / CDC with focus on' Make in India' and funding from the state and central governments. It was built in a record time, and evaluated. He added that support and urgent intervention from regulatory bodies (CDSCO / FDA), ICMR assessment centre, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.

Mylab has experience of many years in the manufacture of RTPCR kits. It manufactures a range of kits at the facility approved by Indian FDA / CDSCO and complies with MDR 2017 regulation for the production of Class C and Class D medical devices, the government's most stringent and regulated products. Mylab also provides blood bank / hospital ID-NAT screening kits, Quantitative HIV, HBV, and HCV kits. Mylab also obtained approval from the Indian Drugs Controller General (DCGI) in the same facility to manufacture the COVID-19 Qualitative Kit. The Mylab COVID-19 kit was evaluated in the Indian Medical Research Council (ICMR).

Shailendra Kawade, Executive Director at Mylab said Mylab is trying to make cutting edge technology accessible at a fair and affordable price for our country. Since this test is based on responsive PCR technology, it is possible to detect even early-stage infection with the highest accuracy as seen in ICMR testing. The kit tested by ICMR and authorised by CDSCO also allows detection faster.

India is currently ranked lowest in terms of testing done per million population. The number reaches as low as 6.8. Countries like South Korea and Singapore could contain the increasing number of cases of Coronavirus by increasing the number of tests.

The Indian government has so far imported millions of test kits from Germany to promote research to diagnose PAN-India patients with Coronavirus. The reliance on foreign kits has been problematic, however, and supply is being blocked due to excessive grounded airlines. This may improve with the Indian kits approval.

Mylab has said it will be able to produce up to 1 lakh test in a week that can be further scaled if necessary. The company further says its test kits are capable of evaluating around 100 patients in one sample. An average PCR-automated laboratory can check over 1000 patients a day. It will be a breakthrough for India with local procurement of test kits as Mylab's test kit will cost nearly one-fourth of the current procurement cost. In addition, Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours compared to more than seven hours of existing protocols. This means laboratories can perform twice as many reactions simultaneously on one computer.

The Mylab manufacturing facility, licensed by FDA / CDSCO, complies with MDR 2017 Class A, B, C and D medical device manufacturing regulations and ISO 13485: 2016 certification.