Adaptive Biotechnologies launched a new diagnostic test for COVID-19 that uses machine learning technology from Microsoft to detect prior coronavirus infections.
The Food and Drug Administration (FDA) last week issued an emergency use authorization (EUA) for the biotech company's T-cell-based test, called T-Detect COVID, which is the first screening to detect past COVID-19 infections using an individual’s T-cell profile.
Adaptive Biotechnologies' screening searches for T-cell responses against COVID-19 in the blood, rather than the immune proteins detected by conventional tests.
"People who have been unsure about a prior infection will now have another way to know if they had the virus,” said Chad Robins, CEO of Adaptive Biotechnologies, in a statement. “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.”
The FDA's EUA was based on a clinical validation study showing that T-Detect COVID demonstrated a 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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Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said the authorization further underscores the FDA’s commitment to innovation in test development.
"The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data that deepen our understanding of SARS-CoV-2 remain important keys to get ahead of this global pandemic," Shuren said.
When Adaptive and tech giant Microsoft first teamed up in 2018, they were using cloud computing to “decode” the immune system. The goal of the partnership was to use the biotech company’s immune sequencing capabilities combined with Microsoft's cloud computing to create a universal blood test that reads a person’s immune system to diagnose and treat diseases.
When the coronavirus began to surge in the U.S back in March, Seattle-based Adaptive pivoted to focus on how the immune system responds to COVID-19.
T cells are the adaptive immune system’s first responders to detect any virus. These cells also recruit B cells to produce antibodies after about a week or two to potentially provide immunity against future infection, according to the company.
To date, testing for COVID-19 has either been in the form of a viral test to detect the presence of the virus or a serology test to detect the presence of antibodies to signal prior infection.
"We cannot go after just one approach. There is an important third pillar which is the cellular basis of immunity," Lance Baldo, M.D., chief medical officer at Adaptive, told Fierce Healthcare.
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T cells can “remember” prior infections and kill pathogens if they reappear. Research shows antibodies to SARS-CoV-2 decline over time. T cells hold important clues to immunity and need to be studied to assess how long patients remain resistant to reinfection, according to Adaptive.
As part of their research partnership, Microsoft and Adaptive also launched the ImmuneCODE database that provides a detailed population-level view into the adaptive immune response to the virus. The database is freely available to researchers.
Baldo said Microsoft's machine learning and cloud computing technology played a key role in developing the T cell-based test.
"We were able to do 10 years of research in about 10 weeks," he said. "We could never have done it quickly without the support of Microsoft."
Adapative's work marks 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 and incubations at Microsoft, in a statement.
“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.”
Spun out from the Fred Hutchinson Cancer Research Center a decade ago, Adaptive focuses on developing personalized diagnostics and therapeutics using its "immune medicine" platform.
Microsoft invested $45 million in the company two years ago as part of its partnership, placing a big bet on the use of its cloud technology in life sciences and Adaptive's capabilities to improve disease detection.
Adaptive went public in June 2019, closing up more than 100% at $40.30 a share on its first trading day, making it at the time in the top five IPO debuts that year, according to CNBC.