T-Detect is currently under review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA)
Patients can conveniently opt to visit one of nearly 2,000 Labcorp sites or arrange for a mobile phlebotomy service at their home
Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced the launch of T-Detect™ COVID, the first clinical T-cell based test to confirm recent or prior COVID-19 infection. In real-world studies, this first-in-class test outperformed leading antibody tests.
Knowledge of prior COVID-19 infection is critically important for those who believe they may have been infected with the virus but have not been able to confirm a diagnosis. T-Detect is currently under review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
“The impact of COVID-19 has become its own public health crisis, with millions of people, like me, who are dealing with serious, long-term effects of this virus,” said Diana Berrent, founder, Survivor Corps, the largest grassroots movement in America dedicated to actively ending this pandemic. “A T-cell test is an important tool for people who want to know if they had COVID-19 and may help them to understand and address ongoing health issues. It is important for patients to participate in ongoing research so that in the future, the same test may help answer questions about immunity to and protection from the virus or to a vaccine.”
Patients can order T-Detect COVID online at www.t-detect.com by answering a few eligibility questions through a secure portal. A virtual provider will authorize a prescription and patients can have their blood drawn by a mobile phlebotomist at their home or they can visit one of nearly 2,000 Labcorp patient service centers. Patients will receive an email notification when their results are available, and they can view them via a secure portal.
“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,” said Adaptive Biotechnologies Chief Executive Officer, Chad Robins. “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.”
Until now, antibody tests have been the primary way to determine recent or prior COVID-19 infection. T-cell tests take an entirely new approach to determine prior infection by looking at a different but equally important part of our immune system, the T cell. In the setting of COVID-19, T-cell responses arise earlier than antibodies and persist in the blood for longer.
Patients ordering T-Detect COVID have the opportunity to contribute to ongoing research to further the understanding of T cell-based immunity to COVID-19. This is particularly important as scientists work to define immunity and establish correlates of protection to SARS-CoV-2, the virus that causes COVID-19, resulting from natural infection or vaccination.
About the T cell
T cells are the adaptive immune system’s first responders to detect any virus. They quickly multiply and circulate in the blood to attack the virus, often before symptoms appear. Among many other jobs, T cells also recruit B cells to produce antibodies after about a week or two to potentially provide immunity against future infection. T cells contain a treasure trove of information that could provide one consistent and trackable measure of the immune response to COVID-19 from initial exposure through viral clearance.
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 in vitro diagnostic that is available for prescription use only. This test has not been cleared or approved by the FDA and is available for use as a CLIA-validated laboratory developed test (LDT). T-Detect COVID is not indicated for use in patients under age 18.