Mylab and Hemex Health launch Gazelle PathoCatch COVID-19 FIA test

This portable, lightweight test detects all COVID-19 variants in 20 seconds

Mylab Discovery Solutions and Hemex Health, a medical diagnostic device company has announced the official launch of the Gazelle PathoCatch COVID-19 FIA test, their first co-developed diagnostic solution for point-of-care (POC) COVID-19 testing in India. This portable, lightweight test detects all COVID-19 variants in 20 seconds compared to the gold standard, PCR. The diagnostic is currently under review with US FDA for Emergency Use Authorisation and will launch in Africa and the Middle East later this summer.

Hasmukh Rawal, Managing Director, 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. We are confident that Gazelle™ PathoCatch™ COVID-19 FIA test will further boost the COVID-19 testing capability and speed up the testing process in India and in international markets. This also marks our foray into manufacturing of diagnostic products for international manufacturers.”

The Gazelle PathoCatch test includes a fluorescent lateral flow immunoassay (FIA) and a reader that utilises image-recognition software for 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. Approved by ICMR and CDSCO, it will be useful for hospitals, universities and airports, where quick results are essential.

Data from POC clinical studies with symptomatic and asymptomatic subjects, conducted in both Bellingham, WA 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.

Patti White, CEO and Co-Founder, Hemex Health said, “The pandemic has driven home the need in all markets for faster, more accessible and more affordable POC diagnostics. Gazelle was positioned to help provide a solution to the testing effort with its fast and detailed analyses. Using our AI and FIA technologies, we discovered we could find even the smallest trace of virus in a sample. We are excited to bring this product to the consumer market to aid in the pandemic fight and be there ahead of the next wave.”