Preliminary Real-World Study Data Proves T-Cell Tests Pass Antibody Tests in Identifying Past SARS-CoV-2 Infections



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– The results support the upcoming launch of T-Detect COVID, first T-cell test for the new coronavirus
– The data supports mounting evidence that measurement T-cellS. is necessary for completely featureis immune responses to SARS-CoV-2 through the population
– Additional support data to be published soon

SEATTLE, November 13, 2020 (GLOBE NEWSWIRE) – Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company aiming to translate adaptive immune system genetics into clinical products to diagnose and treat disease, announced today that its T-Detect ™ test for a previous SARS-CoV-2 infection under development identified 97% (68/70) of previous PCR-confirmed SARS-CoV-2 infections compared to 77% (54/70 ) with UEA-approved antibody tests of similar specificity approximately two months after PCR diagnosis. In addition, the T-cell response was greater in symptomatic than in asymptomatic subjects, while there was no correlation between antibody levels and disease severity in recovered patients. The preliminary results of this study were made available on medRxiv, carried out in collaboration with the University of Padua and the San Raffaele Hospital in Milan, funded by a contribution from the Umberto Veronesi Foundation. T-Detect ™ COVID will be launched later this fall, becoming the first T-cell-based clinical diagnostic test capable of confirming past infections from SARS-CoV-2.

Some people are likely never to develop antibodies to SARS-CoV-2 because they can resolve the infection early and effectively with T cells. Recent studies have shown that antibodies appear to decrease over time¹, while virus-specific T cells have shown to persist for at least six months². This new study adds to the growing evidence that T cells, along with antibodies, can serve as an important correlate of immune protection and can help provide a more complete picture of the duration of immunity to the virus following infection or administration of a vaccine.

“These data add to the growing body of real-world evidence that the T cell plays a vital role in immunity to SARS-CoV-2,” said Lance Baldo, Chief Medical Officer of Adaptive Biotechnologies. “T cells are emerging as another key indicator for past infections and immunity to the novel coronavirus, and a patient T cell test that is accurate and reproducible can serve large populations of people, given what we are learning. on the biology of the immune response. “

A first study published in Nature in June 2020 was conducted by the University of Padua in which almost the entire population of Vo ‘, Italy (2,900 of the 3,275 residents of the city), was tested using PCR for SARS infection. CoV-2 at the beginning and end of a 14-day city block, followed by longer-term clinical monitoring. At that time, 81 people in the city tested positive for the virus in at least one of two polls. Interestingly, more than 40% of those who tested positive were asymptomatic, driving the city’s response to the then emerging pandemic and driving their success in containment³.

In a follow-up study of 2,290 residents, including 70 of 81 PCR positive results, antibody testing with an EU approved commercial test (IgG) and T-cell test with Adaptive’s T-Detect test for SARS- CoV-2 passed infection was performed approximately 60 days after the PCR test. The T cell test identified 97% (68/70) of previous PCR-confirmed SARS-CoV-2 infections compared with 77% (54/70) with the antibody test. Notably, 24 of 70 PCR-positive patients were asymptomatic, highlighting the increased sensitivity of T-cell-based tests to provide a more accurate representation of past infection in a community. T cell response was measured by the overall amount of T cells and the number of unique virus-specific T cells. Convalescent subjects who were symptomatic and hospitalized with COVID-19 had a significantly greater T-cell response than asymptomatic subjects, while antibody levels were not related to disease severity.

Notably, another 45 (2.0%) of the PCR negative participants tested positive with the T-Detect test for a previous SARS-CoV-2 infection. About half of these individuals reported symptoms before or after PCR testing or home exposure, indicating that the T-cell test can also identify past infections that were ignored by previous PCR tests.

About T-Detect
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 collaborated 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 diseases, and cancer. From a simple blood draw, T-Detect will leverage the map to provide an immune status for an individual, enabling early disease detection, disease monitoring, and critical immunity insights. T-Detect COVID will be the first clinical trial launched by this collaboration and the first commercially available T-cell test designed to detect past infections from SARS-CoV-2. The launch is expected in the fall.

About Adaptive Biotechnology
Adaptive Biotechnologies is a commercial stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform disease diagnosis and treatment. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic system for most diseases, but the inability to decode it has prevented the medical community from fully exploiting its capabilities. Our proprietary immune medicine platform reveals and translates the enormous genetics of the adaptive immune system with scale, precision and speed to develop products in life science research, clinical diagnostics, and drug discovery. We have two commercial products and a strong clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases. Our goal is to develop and market immune-based clinical products tailored to each individual patient. For more information, visit adaptivebiotech.com and follow us on www.twitter.com/adaptivebiotech.

Forward-Looking Statements

This press release contains forward-looking statements based on management’s beliefs and assumptions and information currently available to management. All statements contained in this release, other than statements of historical facts, are forward-looking statements.

These statements involve risks, uncertainties and other factors that could cause actual results, business levels, performance or results to differ materially from the information expressed or implied in these forward-looking statements, including statements regarding T-Detect ™ and the its launch, potential commercial acceptance, or clinical utility, with respect to COVID-19 or other disease states. These risks, uncertainties and other factors are described in “Risk Factors”, “Management Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in documents we file with the Securities and Exchange Commission from time to time, including a quarterly report on Form 10-Q to be submitted by today. We caution you that forward-looking statements are based on a combination of facts and factors currently known to us and our projections for the future, of which we cannot be certain. As a result, forward-looking statements may not prove accurate. The forward-looking statements in this press release represent our views as of the date of this document. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

ADAPTIVE SUPPORTS
Beth Keshishian
917-912-7195
[email protected]

ADAPTIVE INVESTORS
Karina Calzadilla, Vice President, Investor Relations
201-396-1687
Carrie Mendivil, Gilmartin Group
[email protected]

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¹ Ward, et al. MedRxiV preprint, 2020
Uo Zuo, et al. bioRxiV preprint, 2020
³ Lavezzo, et al. Nature, 2020



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