Hemex Health, Mylab Discovery Solutions launch Gazelle PathoCatch COVID-19 FIA Test

The portable, lightweight test detects all COVID-19 variants in 20 seconds with 99.4 per cent accuracy compared to the gold standard, PCR

Mylab Discovery Solutions and Portland, OR-based Hemex Health, a medical diagnostic device company focussed on creating diagnostics to transform frontline healthcare, 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.

“Studies show that minimising testing delay has the largest impact on reducing transmission,” said Hasmukh Rawal, MD, Mylab Discovery Solutions. “We are excited to introduce this very affordable, highly accurate test into the market. It will be a great solution for hospitals, universities, and airports, where quick results are essential.”

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.

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 are currently under peer review.

“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. “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 the 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.”