NEW YORK – Adaptive Biotechnologies thinks its T-Detect test, launched this week for T cell-based diagnosis of COVID-19 infection, could be as disruptive to the molecular diagnostics industry as the Tesla Roadster was to the auto industry.
T-Detect COVID is the first iteration of the Seattle-based firm's test that uses its immune repertoire sequencing technology as a clinical assay. According to Adaptive, the test boasts sensitivity of 94 percent 15 days or longer after the onset of symptoms and 95 percent at five or more months after diagnosis with PCR, beating serology test sensitivity of 88 to 90 percent and 52 to 71 percent, respectively. T-Detect COVID has specificity of greater than 99 percent. Adaptive researchers posted these results from a study of 784 cases and 2,447 controls as a preprint on MedRxiv in January.
While Adaptive has been touting their clinical test for more than a year, the ability to already meet the performance of serology tests surprised Chief Scientific Officer and Cofounder Harlan Robins. He compared the test's launch to the unveiling of the Tesla Roadster electric sports car in 2006.
"There they released a product that probably wasn't designed to be a big commercial product, but they showed that an electric car could outperform a Ferrari," he Robins told investors on a conference call following the release of the firm's Q4 and full-year 2020 results. "If I had been paying attention, if everybody else had really been paying attention, I think we would have realized that it was, at that point, sort of fait accompli that we would all end up with electric cars."
"The analogy is a science and engineering analogy about new technologies and not about Telsa's value or commercial opportunity," he later clarified in an email. "The analogy is about disruptive technologies and their future potential."
As electric cars have not completely taken over roadways, "it may take time for T-Detect to become mainstream," Adaptive CEO and Cofounder Chad Robins noted. "But the stage is set."
"T cells see all diseases in the exact same way," he said. "And T-Detect will translate this natural capability of T cells into a broadly applicable test that will change the diagnostic paradigm."
On the call, Adaptive officials provided details from their T-Detect early-access program, expanded upon their regulatory and marketing strategies for the COVID-19 test, and teased future development paths for the T-Detect technology.
Based on the firm's ImmunoSeq assay for T-cell receptor analysis, T-Detect COVID is being launched as a laboratory-developed test for self-pay customers. The test costs $150, plus fees, including a $9 test authorization fee and blood draw at either a LabCorp facility for $60, or at-home for $140.
Customers will order the test online, where a virtual provider will authorize a prescription for eligible customers.
Adaptive's early-access program for T-Detect COVID, launched at the end of 2020, saw approximately 660 tests ordered, with 13 concierge medicine groups and 60 percent participation in an opt-in program to make the results available for future research.
With the caveats that the program took place over the holidays, received no marketing, and did not feature virtual prescribers, Adaptive President Julie Rubinstein said the program signaled "a good appreciation for interest in T cell testing" and that Adaptive expects the test to grow.
"We recognize that things may change with … widespread vaccination," she said. "But what we do know is that the T cells matter… As we've always said from the start, it's really about validating both our platform, and the utility of reading T cells in blood across diseases."
On the T-Detect website, Adaptive noted that it was unclear what effect COVID-19 vaccines would have on test results but said it was gathering data on the topic and would provide updates as they are available. "It is possible to distinguish vaccines from community acquired infection by looking at the concentration of signal around the spike protein region of the virus," Harlan Robins said in an email. "Adaptive is exploring the opportunity to report this characterization as a feature in future enhancements of T-Detect."
Adaptive officials said the company is now engaging in "targeted marketing" for the test.
Adaptive has filed for Emergency Use Authorization from the US Food and Drug Administration for T-Detect COVID and is "actively working with the FDA on final details including labeling," Rubinstein said. "We anticipate obtaining EUA clearance as the first T-cell based test to be validated by the FDA."
"The FDA has reviewed and provided encouraging feedback on our EUA submission," Chad Robins said. "FDA is working through how we can implement a new T-cell testing category."
The regulatory process has incurred surprises due to the novelty of the test, Harlan Robins said. "There's no space on the FDA website for a test like us, so they have to literally create a new space on their website in order to put us on there," he said. "So, there's some extra minor time delays here and there, but … we feel very good about it, and they've been great partners on us to date." The experience has also enabled Adaptive to educate the FDA for future T-Detect submissions, Rubinstein noted.
T-Detect tests will show up in the company's clinical sequencing volume reports and small studies involving the test have been factored into Adaptive's guidance for 2021. Harlan Robins suggested its contributions to revenues would be in the "low single digits for the year." Adaptive CFO Chad Cohen said it would be difficult to predict testing volumes and as such the company is not providing more detailed guidance.
Adaptive is making progress on follow-up indications for T-Detect. The firm plans to launch its Lyme disease test in Q4, with their study for that test completed this year.
And its experience with COVID-19 has helped improve its algorithms for finding signals in data for other diseases. "We got many, many thousands of positives and negatives that we're able to really use to improve our algorithms and understanding in conjunction with Microsoft," Harlan Robins said. "For example, we have been sitting on a sample set for multiple sclerosis that we, to be honest, hadn't been making that much headway on and then we started applying some of our algorithmic learning that we had had from COVID. And all of a sudden, a really nice clean signal started appearing… And it's improving our signal in all of our studies, including celiac and Lyme, and Crohn's disease, and a variety of others that we're working on behind the scenes as well."
Progress on developing a T-Detect test for ovarian cancer, the beachhead for oncology, will benefit from the firm's partnership with AstraZeneca announced in January, but "that's going to be a longer time horizon," Chad Robins said.
Earlier this week, Adaptive announced that it has further partnered with LabCorp to provide blood draws for T-Detect. LabCorp will also promote Adaptive's ClonoSeq test for minimal residual disease testing in the US. "It's essentially an agreement whereby we are paying LabCorp a very nominal amount actually to have the opportunity to include ClonoSeq in their oncology reps' bags, and so that they can market ClonoSeq to their community oncology customers," Rubinstein noted.
Adaptive officials also noted that they have submitted a 510(k) application to the FDA to expand the label for its ClonoSeq minimal residual disease test in acute lymphocytic leukemia to include blood-based testing, in addition to bone marrow. "With ongoing data generation and validation efforts, we expect to continue to expand into blood testing for other indications such as multiple myeloma and non-Hodgkin's lymphoma," Rubinstein said.