Mylab Discovery Solutions based in Pune in India and Hemex Health, a medical diagnostic device company based in Portland, Oregon in the US, have officially launched the Gazelle PathoCatch Covid-19 FIA test in India. It is the first jointly developed diagnostic solution for Covid-19 point-of-care by the two companies. The lightweight portable device is claimed to detect all the known Covid-19 variants in 20 seconds with near-PCR accuracy compared to the PCR tests for which, the results are often given in less than an hour in India.
Approved by ICMR and CDSCO, it will be useful for hospitals, universities, and airports, where quick point of care (POC) results are essential. The Gazelle device is still being reviewed by the US FDA for Emergency Use Authorisation and is likely to launch in markets such as Africa and the Middle East later this year.
Mylab Discovery Solutions’ managing director Hasmukh Rawal, stated, “We are pleased to introduce our first next-gen product in partnership with Hemex for the Point-of-Care testing of the coronavirus. We are confident that the 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.”
FIA and AI tech for more accessible and affordable POC tests
The Gazelle PathoCatch test includes a fluorescent lateral flow immunoassay (FIA) and a reader that utilizes 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, Washington in the US and Pune and Mumbai in India, demonstrated 96.2% combined sensitivity, 99.7% combined specificity, and 99.4% combined accuracy in detecting the virus in comparison to the RT-PCR test. Data from these studies are currently under peer review.
Patti White, CEO, and co-founder of 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 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.”