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Pune-based Mylab receives ICMR approval for COVID-19 self-testing kit

Pune-based molecular diagnostics startup Mylab Discovery Solutions has received Indian Council of Medical Research (ICMR) approval for its self-use Rapid Antigen Test (RAT) for COVID-19.

Named CoviSelfTM, the test will be useful for symptomatic individuals or those who were in contact with positive cases.

In a statement, Mylab said that each of the CoviSelf test kits will come with all the testing materials, instructions to use, and a biohazard bag to safely dispose of after testing. People can test themselves using a nasal swab and the test kit will provide the results in 15 minutes. 

According to ICMR guidelines, all individuals testing positive after the test will need to immediately follow COVID-19 procedures, and repeat testing will not be required. Those who test negative and continue to experience COVID-like symptoms should seek follow-up care from their healthcare provider, it said.

[Image Credit: Mylab Discovery Solutions]

According to the official statement, users will be able to test themselves without the need for sample collection by healthcare professionals, thus reducing the pressure on the healthcare sector. ICMR said symptomatic individuals can do the test, and results will be available to them over a mobile app. 

“Data in the app of your mobile phone will be centrally captured in a secure server, which is connected with the ICMR COVID-19 testing portal, where all data will be eventually stored,” ICRM said in a statement.

“This is the biggest crisis our country has ever faced. With CoviSelfTM, we are sharing the power of testing early with the citizens. It will save thousands of lives. For India, we will make millions of kits available at a fraction of the cost of such kits in the US,” Hasmukh Rawal, Managing Director of Mylab Discovery Solutions said in a statement.

The startup revealed that it will soon begin to ship out tests and the test kits will be available at Rs 250. According to Mylab, its current production capacity is 70 lakh tests per week, and is working to increase it to one crore test per week within the next 14 days.

Speaking about the development, Sujit Jain, Director at Mylab Discovery Solutions, said, “Most western countries have allowed self-test for their citizens and consider it as a powerful tool to break the chain. This easy-to-use test combines with Myab’s AI-powered mobile app so that a user can know his/her positive status, submit the result to ICMR directly for traceability, and know what to do next in either case of result. We are sure this small step will be a big leap in mitigating the second and subsequent waves.“

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