T-Detect is a sensitive and specific diagnostic test, which is being developed for multiple diseases
Adaptive Biotechnologies has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its T-Detect COVID test to confirm recent or prior Covid-19 infection.
The T cell-based test is said to be the first indication developed under Adaptive’s TCR-Antigen Map collaboration with Microsoft.
The EUA status was provided on a clinical validation study, which demonstrated that T-Detect COVID shown a sensitivity of 97.1% from the date of diagnosis using RT-PCR.
According to the company, T cells contain significant information to help measure the immune response to Covid-19 from initial exposure through viral clearance.
Adaptive Biotechnologies CEO Chad Robins said: “The authorisation 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.”
T-Detect is a sensitive and specific diagnostic test, which is being developed for multiple diseases.
In 2018, Adaptive collaborated with Microsoft to design a map of the immune system known as the TCR-Antigen Map.
The immunosequencing, computational modelling and machine learning capabilities are used for the mapping of T-cell receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders and cancer.
T-Detect will leverage the map to offer an immunostatus for an individual from a simple blood draw. It will facilitate early disease diagnosis, disease monitoring, and critical insights into immunity.
Adaptive also offers the FDA-approved clonoSEQ assay, which helps to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL).