On Aug. 31, 2020, T2 Biosystems announced that the FDA had issued an Emergency Use Authorization (EUA) for its COVID-19 molecular diagnostic test, the T2SARS-CoV-2ﾙ Panel. The T2SARS-CoV-2 Panel is a molecular diagnostic test that detects SARS-CoV-2, the virus responsible for COVID-19 infections, and provides results in under two hours utilizing a nasopharyngeal swab sample.

The test runs on the Companyﾒs FDA-cleared and fully-automated T2Dxﾮ Instrument, which is capable of performing seven tests simultaneously. Clinical testing on both positive and negative patient samples demonstrated a sensitivity of 95% and specificity of 100%.