Pune: At a time when coronavirus cases are gradually rising in India, there is good news as far as testing is concerned.
A kit that can reportedly detect all COVID-19 variants within 20 seconds will soon be available in India, Pune-based Mylab Discovery Solutions and US-based Hemex Health announced.
According to a Mylab statement issued on Monday, the kit is currently under review with the US FDA for Emergency Use Authorization and will be launched in Africa and Middle-East later this summer.
“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,” said Hasmukh Rawal, managing director of Mylab Discovery Solutions.
The kit has been approved by Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organisation (CDSCO), and can be used in hospitals, universities and airports, where quick results are needed.
Data from clinical studies conducted in Washington, Pune and Mumbai, demonstrated 96.2% combined sensitivity, 99.7% combined specificity and 99.4% combined accuracy at detecting the virus in comparison to RT-PCR.
All the data 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 Hemex Health CEO and Co-Founder Patti White.
