T2's COVID-19 molecular test gets FDA nod

2019 09 16 18 27 8672 Quality Check Mark 400

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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