FDA Grants EUA for Adaptive Biotechnologies’ T Cell COVID-19 Test
The FDA has given Adaptive Biotechnologies Emergency Use Authorization (EUA) for its T-Detect COVID test, a diagnostic that identifies patients that show a T cell immune response to the COVID-19 virus.
The test evaluates DNA from T-cells, also known as white blood cells, to provide a positive or negative result for recent or prior infection with SARS-CoV-2.
The agency advised that results from the T-Detect test should be used in combination with clinical exams, patient medical history and other findings, and should not be used to diagnose current SARS-CoV-2 infection. The EUA currently limits testing to certified laboratories designed by Adaptive Biotechnologies.