GenMark Diagnostics Announces Submission of Emergency Use Authorization for its ePlex® SARS-CoV-2 Test
“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
“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.
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.
About GenMark Diagnostics
Forward Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our ability to secure an EUA from the FDA for our ePlex SARS-CoV-2 Test, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, our ability to successfully demonstrate the clinical performance and utility of our ePlex SARS-CoV-2 Test, the continued progression of the associated public health emergency, and other risks and uncertainties described under the "Risk Factors" in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
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Source: GenMark Diagnostics, Inc.