T2 Biosystems Gets FDA EUA for SARS-CoV-2 Molecular Diagnostic Test

Aug 31, 2020

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NEW YORK – T2 Biosystems said on Monday that the US Food and Drug Administration has issued Emergency Use Authorization (EUA) for the firm's COVID-19 molecular diagnostic test.

Lexington, Massachusetts-based T2 Bio's T2SARS-CoV-2 panel detects SARS-CoV-2 within two hours using a nasopharyngeal swab sample and runs on the firm's T2Dx instrument.

The firm said that the test has a clinical sensitivity of 95 percent and specificity of 100 percent.

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T2 Biosystems Gets FDA EUA for SARS-CoV-2 Molecular Diagnostic Test

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