At Adaptive Biotechnologies, we’ve spent over a decade building our proprietary immune medicine platform to decode the adaptive immune system to learn how it naturally detects and fights a multitude of diseases.
Through a collaboration with Microsoft, we are using our platform and Microsoft’s AI and Machine Learning to develop a TCR-antigen map, a map of T cells, the first responders of the adaptive immune system, to the antigens they bind. Using this data, we aim to translate the natural diagnostic capability of the immune system into the clinic.
When the pandemic began, we extended our platform to COVID-19 to develop the first-ever T cell-based clinical test that can detect an immune response to recent or past COVID-19 infection.
The T-Detect approach
Development of the first T cell-based clinical test for COVID-19
Watch the video to learn how Adaptive developed the first T cell-based clinical test for COVID-19:
Using a set of identified “shared” T-cell receptors (TCRs) that are seen across multiple infected individuals, we identified a T-cell signature that can be used to develop a clinical test.
This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA.
Testing of venous whole blood using K2 EDTA specimens is limited to laboratories designated by Adaptive Biotechnologies Corporation that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets the requirements to perform high complexity tests as described in the T-Detect COVID Test Standard Operating Procedure that was reviewed by the FDA under this EUA.
This test has been authorized only for detecting and identifying the presence of an adaptive T-cell immune response to SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
T-Detect™ COVID is not indicated for use in patients under age 18.