COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues EUA for NGS Test to Identify T Cell Immunity for COVID-19

FDA maze of regulations

New FDA authorization allows for T cell immunity testing for COVID-19

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a new COVID-19-related test that is a first of its kind. This EUA was issued March 5, 2021, for Adaptive Biotechnologies’ T-Detect COVID Test.

The T-Detect COVID Test uses next-generation sequencing (NGS) to determine if an individual’s T cells have formed an immune response. Until now, many of the clinical tests used to assess immune response have focused on the presence of antibodies, not the T cells that produce them. This area of COVID-19 testing could potentially hold the key to long-term immunity.

Todays authorization further underscores the FDAs commitment to innovation in test development,” said Jeffrey Shuren, MD, JD, Director of FDAs Center for Devices and Radiological Health. 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 ability to test for T-cell response can be used to indicate a recent or a prior SARS-CoV-2 infection while a negative test means this is unlikely. The FDA points out that this test should not be used for the diagnosis of an acute SARS-CoV-2 infection. The FDA also clearly states, “it is unknown how long the T cell immune response remains following infection and what level of protection may be provided by the presence of a T-cell immune response.”

While T-cell immunity is still a very active field of COVID-19 study, this new test now allows clinicians to offer T-cell COVID-19 testing for their patients.

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