GenMark Diagnostics, Inc., a provider of automated, multiplex molecular diagnostic testing systems, announced submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its ePlex SARS-CoV-2 Test. Upon issuance of an EUA, the ePlex test could be utilized by clinical laboratories for detection of SARS-CoV-2. Initial Research Use Only (RUO) tests were shipped last week to several key customers to validate the assay design using clinical samples.
“Our priority was to help our customers address this global health emergency. We leveraged our adaptable and easy-to-use ePlex platform to quickly design and manufacture a test to accurately detect this highly contagious virus in clinical samples,” said Scott Mendel, Interim Chief Executive Officer. “EUA submission in just over a week from the initial RUO shipments of our ePlex test is a critical step to enable our customers to rapidly detect and possibly prevent the spread of the COVID-19 virus.”
“Getting tests to detect COVID-19 in the hands of our physicians and clinicians as soon as possible is one of our highest priorities in combatting this rapidly expanding health emergency,” said Dr. Dwayne Breining, Executive Director of Labs, Northwell Health. “GenMark is an important Northwell partner in molecular diagnostics and we are grateful to their team for continuing to push forward a test that can rapidly identify patients with SARS-CoV-2. We strongly support their efforts to gain an EUA and have provided clinical sample data from our early access to expedite this process.”
GenMark’s request for EUA is currently under review by the FDA. If the FDA concludes that the criteria for issuance of an EUA has been met, the company will begin shipment of test kits to its customers for routine clinical use.
