T2's COVID-19 molecular test gets FDA nod

By LabPulse.com staff writers

September 2, 2020 -- The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization to T2 Biosystems for its COVID-19 molecular diagnostic test, T2SARS-CoV-2 Panel.

The assay tests for the SARS-CoV-2 virus using nasopharyngeal swab samples and provides results in less than two hours. The panel runs on the company's FDA-cleared and automated T2Dx instrument, which can perform seven tests simultaneously. It demonstrated a sensitivity of 95% and specificity of 100% on both positive and negative patient samples, according to the company.

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