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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » FDA Issues Emergency Use Authorization for GenMark Coronavirus Assay

FDA Issues Emergency Use Authorization for GenMark Coronavirus Assay

Mar 19, 2020
|
staff reporter

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.

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