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Pune-based startup Mylab Discovery Solutions and US-based Hemex Health, a medical diagnostic device company focussed on creating diagnostics to transform frontline healthcare, have announced the official launch of the Gazelle PathoCatch COVID-19 FIA test, their collaborative diagnostic solution for point-of-care (POC) testing in India.
This portable, lightweight test detects all COVID-19 variants in 20 seconds with 99.4 per cent accuracy compared to the gold standard, PCR. The diagnostic is currently under review with US FDA for Emergency Use Authorization and will launch in Africa and the Middle East later this summer.
The Gazelle PathoCatch test includes a fluorescent lateral flow immunoassay (FIA) and a reader that utilises image-recognition software for the detection of nucleocapsid protein from SARS-CoV-2. The reader uses AI imaging and signal-to-noise enhancement techniques to achieve near-PCR accuracy. Specimens are collected using a nasal swab.
