NEW YORK – Having secured a Medicare coverage recommendation from the MolDx program for its first T-cell-based diagnostic, T-Detect COVID, Adaptive Biotech is now building evidence for the assay's unique utility and hoping that its clinical establishment will accelerate validation and adoption of the same technology in other diagnostic tests.
The company's near-term plans include launching its second test of this kind, T-Detect Lyme, before the start of the Lyme disease season next year. Adaptive is also developing similar tests for Crohn's disease and multiple sclerosis, and is working to establish its technology in vaccine development efforts for COVID-19 and potentially other infectious diseases.
During a call discussing the company's third quarter financial results this week, CEO Chad Robins said that he views the reimbursement nod for T-Detect COVID as a milestone not just for the COVID test, but for the firm's larger franchise. That said, the positive assessment is only a first step forward.
Adaptive's immediate focus is now on capturing the market potential conferred by the MolDx determination, which it said outlines payment for the assay at $770 per test for a specific population: immunocompromised patients.
According to Nitin Sood, Adaptive's chief commercial officer, this designation reflects the potential of its test to help physicians make decisions about patient treatment, including how and when to vaccinate and, potentially, how and when to use preemptive or prophylactic treatments.
"Physicians can use this to help them manage care, particularly for immunocompromised patients, helping [them] make decisions related to vaccines or vaccine boosters in patients who are on immune suppressing medications, including deferring or postponing such medications or even providing preventative monoclonal antibody treatment," said Sood.
"We have said from the beginning that unfortunately this [virus] is going to be endemic in our population and this subset of patients, they're always going to be at risk even as the virus moves from the pandemic state to an endemic state," Robins added.
While estimates vary, Robins said that there are around 7 million immunocompromised individuals in the US, about a million of which are the hematologic cancer patients that the company already serves with its ClonoSeq assay, so that will be the company's first commercial target.
According to Sood, the plan is to use the ClonoSeq sales team to approach those physicians, which include hematologists and oncologists. After that, Adaptive would work on targeted promotion in transplant centers, HIV treatment centers, and among autoimmune disease physicians.
"This is not only a new product launch, but it's a new product category, so in terms of how quickly we can [gain adoption], the good news is that the world has been talking about the adaptive immune response to the virus ... so some of that marketing effort is done. But in terms of the specific use case — how and when you use it, what therapeutic regimens or lifestyle choices will a doctor provide you to assist in the management of patients — this all has to be worked into the current paradigm of care," Robins said.
Sood added that, long term, Adaptive is also generating additional evidence to make the test semi-quantitative so that it can generate a readout of the level of disease protection. "We think this is going to be not only beneficial to physicians … but also really strengthen our value proposition to vaccine developers," he said.
Given the success of mRNA vaccines in the COVID-19 pandemic response, Sood said that it makes sense to expect a lot of activity in vaccine development going forward, even beyond COVID. "I think having a test that measures the T-cell response quantitatively and produces evidence around protection will open up a whole bunch of doors," he said.
Harlan Robins, Adaptive's chief scientific officer, added that technologies like Adaptive's are relative youngsters compared to other ways of assessing immune response.
"I don't think everybody really appreciated the role that the cellular immune system is playing in protection," he said. "In part, this is probably just historical that we've had the ability to measure an antibody response and even a neutralizing antibody response for 50 years. And we didn't really have a way of measuring the T-cell response at scale."
"Now that we do and also now that we're in this situation where we're seeing these new variants that are really avoiding the neutralizing antibody response from the vaccines … we're seeing the importance of the T-cell response to really give us the protection that we need to prevent severe disease," he added.
"The T-cell revolution is coming," but it will be up to Adaptive, Robins said, to further prove that T-cell response truly correlates with disease protection. "If we can show that directly, then we really have the tool that people can use going forward in a whole variety of … diseases to help them develop the right vaccine, but also prove that their vaccine is working."
Turning to Lyme disease and other applications, Robins highlighted Adaptive's completion of a study, presented last month at the IDWeek 2021 meeting, showing its T-cell based diagnostic was nearly two times more sensitive than standard testing in identifying individuals with early disease.
"This is the second technical proof of concept that our T-cell testing has advantages over serology in the diagnosis of infectious diseases," he said.
Sood added that the company is engaging with payors with the anticipation of launching the test in time for the emergence of another Lyme disease season next year.
In inflammatory bowel disease, Robins said Adaptive had analyzed about 80 percent of a set of 5,000 samples as part of its validation of a detection assay for ileal Crohn's disease. "We expect to have the totality of the data completed by year-end, and we'll share next steps for development at that time," he said.
Finally, having identified another T cell-based signal in multiple sclerosis, the company now also has its first samples in house for that application, which are currently under analysis.