NEW YORK – With its first T cell sequencing-based diagnostic for COVID-19 infection now authorized for emergency use by the US Food and Drug Administration, Adaptive Biotechnologies is turning its attention to a longer-term goal of adapting the test's core platform away from single-disease applications and toward use in diagnosis and differentiation for broader classes of disease.
This includes the planned launch by the end of this year of T-Detect Lyme, an assay using the same immune profiling technology to diagnose Lyme disease, and a gastrointestinal disease differential diagnostic to follow on its heels.
In a call this week discussing the company's first quarter financial results, Adaptive's president, Julie Rubinstein, argued that the launch and EUA for T-Detect COVID has strategic value for these ongoing expansion plans.
"We believe the R&D and commercial investments made for [this test] will accelerate the rate at which we develop and launch future applications," Rubenstein said. "These include, among others, educating the FDA about the power of T cells and our underlying technology, improving our models and techniques, and building a commercial infrastructure to market the test and serve its customers, all of which was accomplished in a very short period."
According to Rubenstein, since launching the COVID-19 test for clinical use in February, the company has tested over 3,000 customers from over 50 medical practices. About 75 percent of these clinical customers have also consented to participate in ongoing research Adaptive is conducting to better understand immunity to COVID-19, she added.
"Although vaccine rollout will likely diminish the market to confirm prior natural infection, we intend to include a person's COVID status in all future T-detect tests. This may be informative for patients with a broad range of symptoms potentially stemming from a past SARS-CoV-2 infection," Rubenstein said.
However this plays out, the company now intends to push into expanded-use cases for its assay platform, eventually aiming to move "from disease-specific diagnosis to differential diagnosis among patients with shared symptoms and ultimately to population immunomics," Rubenstein said.
This includes launching the Lyme disease test it has been developing as an LDT through its CLIA lab and publishing the results of the ImmuneSense study, in which the assay is being trained, validated by the end of this year.
The company has said previously that results from a study in collaboration with Johns Hopkins University have shown that T-Detect doubled the sensitivity of two-tier serology, which is the current standard of care for acute cases. Preliminary data also suggests that the assay could help identify patients with post-treatment Lyme disease syndrome, where symptoms persist despite antibiotic treatment. This group is estimated to be approximately 200,000 patients per year, Rubenstein said.
Following the Lyme disease application of T-Detect, Adaptive has said previously that it is targeting Crohn's disease, but during the call this week, Rubenstein said that the company now has new preliminary data that supports expanding that plan to a differential diagnostic for patients presenting with shared gastrointestinal symptomology.
"We have completed an additional cohort of patients with ileal Crohn's, which corroborates our early Crohn's signal. From several hundred patients, our classifier is already over 70 percent sensitive at 99 percent specificity for this type of Crohn's disease," Rubenstein said.
More importantly, she added, the data also demonstrate that the T cells that recognize ileal Crohn's are distinct from those that recognize potentially confounding disorders like ulcerative colitis and celiac disease, among others.
"We're super excited about the Crohn's data," said Chad Robins, Adaptive CEO and cofounder, on the call this week. "This data proves that T cells are [extremely] specific, so we can eliminate false positives. For each disease we're going to get better and better on sensitivity, but this data is really the first data that provides the foundation for our thesis of going from looking at single diseases at a time to moving upstream in the clinical paradigm so that doctors are able to differentially diagnose between diseases."
According to Rubenstein, the next step for the GI differential diagnostic is to analyze additional samples from over 5,000 Crohn's and colitis patients, which she said Adaptive already has in house. The company should be able to complete and report on this data by the end of the year.
Adaptive has said previously that it is targeting a price in the range of $600 to $800 per test for Lyme disease. As it pushes forward its GI diagnostic, the company is now consulting specialists in this area of medicine to try to understand the potential product market, and with payers to arrive at a pricing strategy that "contemplates a blood test that can reduce the diagnostic odyssey in an increasingly cost-effective way," Rubenstein said.
As many as 22 million patients with GI symptoms see a primary care doctor each year, she said, with a few million progressing to seeing a GI specialist if inflammatory bowel disease is suspected. That is the population Adaptive is targeting.
"These patients usually take around a year to receive a definitive diagnosis, which requires a biopsy, and the whole process can cost anywhere from $10,000 to $20,000," Rubenstein said. "Our hope is to develop an [alternative] that can offer patients … clarity early on in the testing journey."
In the background of this work, Robins said that research use of Adaptive's ImmunoSeq platform to map disease-associated T-cell activity may also expand in the near future from a current focus on COVID-19 infections to other areas, such as autoimmune disease, which he called an especially promising new target.