
T2 Biosystems received FDA Emergency Use Authorization for COVID-19 molecular diagnostic test
On Aug. 31, 2020, T2 Biosystems 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.
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Source: MassDevice
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