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FDA Issues Emergency Use Authorization for GenMark Coronavirus Assay

NEW YORK – The US Food and Drug Administration has issued Emergency Use Authorization for GenMark Diagnostics' ePlex SARS-CoV-2 Test, the firm announced Thursday evening.

The test qualitatively detects SARS-CoV-2 virus in nasopharyngeal swab samples and is for use on GenMark's sample-to-answer ePlex system, which is based on competitive DNA hybridization and electrochemical detection technology.

The company noted that the global installed base of the instrument stood at more than 500 as of the end of 2019 and added that the platform provides results in less than two hours and can process up to 96 tests per eight-hour shift.

During GenMark's fourth quarter earnings conference call earlier this month, it said that it had begun shipping its SARS-CoV-2 tests to its distributor in Hong Kong and to hospitals in the US, and that it would use information from customers using the test, which was then research use only, to apply to the FDA for EUA.

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