Adaptive Biotechnologies announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for T-Detect™ COVID to confirm recent or prior COVID-19 infection. This first-in-class T cell- based test is the first indication resulting from Adaptive’s TCR-Antigen Map collaboration with Microsoft.
“We are proud to receive FDA Emergency Use Authorization for T-Detect COVID, the first indication in an entirely new class of tests that use T cells in the blood to detect disease. People who have been unsure about a prior infection will now have another way to know if they had the virus,” said Chad Robins, chief executive officer of Adaptive Biotechnologies. “The authorization 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.”
EUA was based on a clinical validation study showing that T-Detect COVID demonstrated sensitivity of 97.1% from date of diagnosis using RT-PCR. Sensitivity is the ability of the test to correctly identify a positive case (true positive). T-Detect COVID also showed a specificity of 100%. Specificity is the ability of the test to identify a negative case (true negative).
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“This is the first commercially available T-cell test that confirms recent or prior SARS-CoV-2 infections in people. T-Detect is accurate and what I find especially remarkable is how rapidly it was developed. Going from the lab to real-world human impact in a matter of months demonstrates the true value of our collaboration and the power of merging biology with cloud-scale machine learning technology,” said Peter Lee, corporate vice president, Research & Incubations, Microsoft. “We are hopeful that this technology will have a meaningful impact not only in the global fight against COVID-19, but in many other disease areas in the future.”
The FDA provides an EUA for medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.
T cells can “remember” prior infections and kill pathogens if they reappear. Research shows that antibodies to SARS-CoV-2 decline over time. T cells hold important clues to immunity and correlates of protection and need to be studied to assess how long patients remain resistant to reinfection. Given T cells circulate freely in the blood, they are an easy and thus a desirable target for assessing SARS-CoV-2 exposure and potentially immunity.
T-Detect™ is a highly sensitive and specific diagnostic test under development for multiple diseases, translating the natural diagnostic capability of T cells into clinical practice. In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map. This approach uses immunosequencing, proprietary computational modeling, and machine learning to map T-cell receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders and cancer. From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. T-Detect COVID is the first clinical test launched from this collaboration and the first commercially available T-cell test designed to detect recent or prior SARS-CoV-2 infections. T-Detect COVID is an EUA authorized test that is available for prescription use only.