CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
March 1, 2021—Adaptive Biotechnologies Corp. launched its T-Detect COVID, a clinical T-cell–based test that identifies people who have evidence of a cellular immune response against SARS-CoV-2. It uses Adaptive’s immunoSEQ technology to sequence T-cell receptors from a blood sample and identifies TCRs that the company has mapped for recognition of SARS-CoV-2 antigens.
“T-Detect COVID is the first T-cell test for patients and the first product resulting from Adaptive’s TCR-Antigen Map collaboration with Microsoft,” Chad Robins, Adaptive’s CEO, said in a press release. “By mapping the human immune response to COVID-19, we have developed a simple blood-based clinical test to help detect recent or prior infections from our T cells. This approach will be scaled for more accurate and early diagnosis of many infectious diseases, autoimmune disorders, and cancer.”
T-Detect COVID is an in vitro diagnostic for prescription use only. It is available for use as a CLIA-validated laboratory-developed test and is under review by the FDA for emergency use authorization; it has not been cleared or approved by the FDA and not indicated for use in patients under age 18. Patients order T-Detect COVID online by answering eligibility questions. A virtual provider authorizes a prescription and patients can have their blood drawn by a mobile phlebotomist at their home or at a Labcorp patient service center.