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NEW YORK – GenMark Diagnostics said on Wednesday that it has submitted its ePlex SARS-CoV-2 test for Emergency Use Authorization (EUA) by the US Food and Drug Administration.

If the FDA concludes the company has met the agency's criteria for issuance of an EUA, GenMark will begin shipping test kits to customers for routine clinical use.

GenMark's coronavirus assay runs on its ePlex sample-to-answer molecular diagnostic system, which is based on competitive DNA hybridization and electrochemical detection technology.

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