T2 Biosystems (NSDQ:TTOO) announced that it received FDA emergency use authorization (EUA) for its COVID-19 test.
Lexington, Mass.-based T2 Biosystems’ T2SARS-CoV-2 Panel is a molecular diagnostic test for detecting SARS-CoV-2, the virus causing COVID-19. The company said in a news release that the test is capable of providing results in under two hours using a nasopharyngeal swab sample.
The test is run on T2 Biosystems’ T2Dx instrument, which can perform analysis on seven tests simultaneously. Clinical testing for positive and negative patient samples resulted in a sensitivity of 95% and specificity of 100%, the company said.
“We believe the emergency use authorization for our COVID-19 molecular diagnostic test will lead to greater adoption of our technology by U.S. hospitals, and we are expanding manufacturing capacity to meet the anticipated demand,” T2 Biosystems president & CEO John Sperzel said in the release. “As critically-ill COVID-19 patients are susceptible to bacterial or fungal co-infections and secondary infections that can lead to sepsis, we believe our platform can be an effective tool to identify acute COVID-19 infections, and optimize outcomes for hospitalized patients under intensive care.”
