FDA Grants EUA for T2 Biosystems’ COVID-19 Molecular Diagnostic

The FDA has granted Emergency Use Authorization (EUA) for T2 Biosystems’ T2SARS-CoV-2 panel, a molecular diagnostic test for COVID-19.

The test provides results in under two hours using samples collected from nasopharyngeal swabs and runs on T2’s FDA-cleared T2Dx instrument, an automated system that can run seven tests at the same time.

T2 said that clinical studies of the test, which used both positive and negative patient samples, showed a sensitivity of 95 percent and a specificity of 100 percent.