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T2 Biosystems Gets FDA EUA for SARS-CoV-2 Molecular Diagnostic Test

NEW YORK – T2 Biosystems said on Monday that the US Food and Drug Administration has issued Emergency Use Authorization (EUA) for the firm's COVID-19 molecular diagnostic test.

Lexington, Massachusetts-based T2 Bio's T2SARS-CoV-2 panel detects SARS-CoV-2 within two hours using a nasopharyngeal swab sample and runs on the firm's T2Dx instrument.

The firm said that the test has a clinical sensitivity of 95 percent and specificity of 100 percent.

"We believe the [EUA] for our COVID-19 molecular diagnostic test will lead to greater adoption of our technology by US hospitals, and we are expanding manufacturing capacity to meet the anticipated demand," John Sperzel, president and CEO of T2 Biosystems, said in a statement. "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."