Next-Generation Sequencing-based Coronavirus Test Authorized

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next-generation sequencing-based test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.

Chad Robins, CEO of Seattle-based 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.”

The test analyzes DNA (deoxyribonucleic acid) sequences from T cells (white blood cells) to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. All test results from the test should be used combined with a clinical examination, patient medical history, and other findings said the FDA on March 5, 2021.

Furthermore, the T-Detect COVID Test should not be used to diagnose current SARS-CoV-2 infection.

“Today’s authorization further underscores the FDA’s commitment to innovation in test development,” stated Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, in a press statement. "The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data that deepen our understanding of SARS-CoV-2 remain important keys to get ahead of this global pandemic.”

The FDA, based in Maryland, is an agency within the U.S. Department of Health and Human Services.