Stock Alert: GenMark Submits EUA For EPlex SARS-CoV-2 Test; Stock Up 13%

(RTTNews) - Shares of GenMark Diagnostics Inc. (GNMK) are rising over 13% in pre-market today, after the company announced submission of Emergency Use Authorization or 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.

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 would begin shipment of test kits to its customers for routine clinical use.