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Kit detecting Covid-19 variants within 20 seconds to be launched in India
The kit is currently under review with the US FDA for Emergency Use Authorization and will be launched in Africa and the Middle East later this summer, a Mylab statement said.
Biotechnology company Mylab Discovery Solutions and US-based Hemex Health have together announced the India launch of a kit that can reportedly detect all Covid-19 variants within 20 seconds.
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The kit is currently under review with the US FDA for Emergency Use Authorization and will be launched in Africa and the Middle East later this summer, a Mylab statement issued Monday said.
Hasmukh Rawal, the managing director of Mylab Discovery Solutions, said: “We are pleased to introduce our first next-gen product in partnership with Hemex for the Point-of-Care (POC) testing of coronavirus… This also marks our foray into manufacturing of diagnostic products for international manufacturers.”
Approved by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO), the kit can be used in hospitals, universities and airports, where quick results are essential.
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Data from POC clinical studies conducted in both Bellingham, Washington and Pune and Mumbai, India, demonstrated 96.2 per cent combined sensitivity, 99.7 per cent combined specificity and 99.4 per cent combined accuracy at detecting the virus in comparison to RT-PCR. Data from these studies is currently under peer review, the statement added.
“The pandemic has driven home the need in all markets for faster, more accessible and more affordable POC diagnostics,” said Patti White, CEO and Co-Founder, Hemex Health.