Adaptive Bio Gets FDA Emergency Use Authorization for T-Detect™ COVID

 First and only clinical T cell-based test for patients to detect the unique T-cell signature specific to SARS-CoV-2, the virus that causes COVID-19

T-Detect COVID correctly confirmed recent or prior COVID-19 infections 97.1% of the time from date of RT-PCR diagnosis with 100% specificity

Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for T-Detect™ COVID to confirm recent or prior COVID-19 infection. This first-in-class T cell- based test is the first indication resulting from Adaptive’s TCR-Antigen Map collaboration with Microsoft (Nasdaq: MSFT).

“We are proud to receive FDA Emergency Use Authorization for T-Detect COVID, the first indication in an entirely new class of tests that use T cells in the blood to detect disease. People who have been unsure about a prior infection will now have another way to know if they had the virus,” said Chad Robins, chief executive officer of Adaptive Biotechnologies. “The authorization of T-Detect COVID represents a true breakthrough for patients and a pivotal milestone for the diagnostic testing paradigm. We have proven that it is possible to read how T cells detect disease in the blood, and this is just the beginning of a pipeline of tests for many other indications.”

https://finance.yahoo.com/news/adaptive-biotechnologies-announces-fda-emergency-234400010.html