Adaptive Biotechnologies Gets FDA EUA for T-Detect to Confirm Recent or Prior Covid-19 Infection

By Josh Beckerman

Adaptive Biotechnologies Corp. said the U.S. Food and Drug Administration issued an Emergency Use Authorization for T-Detect COVID to confirm recent or prior Covid-19 infection.

Shares were recently up 18% to $50 after hours.

The company said the T-cell-based based test is the first indication resulting from Adaptive's TCR-Antigen Map collaboration with Microsoft Corp.

"People who have been unsure about a prior infection will now have another way to know if they had the virus," the company said. "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," the company said.

The EUA was based on a clinical validation study showing that T-Detect COVID demonstrated sensitivity of 97.1% from date of diagnosis using RT-PCR, Adaptive said.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

March 05, 2021 19:13 ET (00:13 GMT)

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