-=T2 Biosystems (TTOO) announces US launch of molecular diagnostic test for COVID-19

T2 Biosystems announces US launch of molecular diagnostic test for COVID-19

T2 Biosystems today announced the completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after validation meeting requirements for an Emergency Use Authorization request to FDA.

The T2SARS-CoV-2 Panel, designed to detect SARS-CoV-2, provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample. Clinical testing on known positive and negative patient samples showed a sensitivity of 95% and specificity of 100%. The T2SARS-CoV-2 Panel runs on the company's FDA-cleared T2Dx Instrument.