NEW YORK – Roughly a year after its launch, Octave Bioscience's Multiple Sclerosis Disease Activity (MSDA) test is being used by several dozen multiple sclerosis clinics around the country, said Founder and CEO William Hagstrom.
The Menlo Park, California-based company is now working to establish payor coverage for the test while continuing to develop clinical evidence supporting its use and building out other parts of its multiple sclerosis management portfolio, Hagstrom said.
Octave's MSDA test measures the levels of 18 proteins in blood to provide a measure of disease activity in individuals with multiple sclerosis. The test was developed on Olink's Explore platform and is run as a custom panel out of Octave's CLIA laboratory using Olink's proximity extension assay technology. Octave launched the test in October 2022 as part of a larger suite of products for managing MS that includes quantitative MRI tools and patient monitoring via wearables, nurse care partners, and other approaches.
The MSDA test is at this point the centerpiece of Octave's efforts. According to Hagstrom, it is meant to help clinicians address "a number of clinical dilemmas throughout the entire course of this multi-decade disease," including better identification of patients at risk of disease progression and providing data that could inform whether to escalate or de-escalate therapy.
Michael Sy, associate professor of clinical neurology and a multiple sclerosis fellow at the University of California, Irvine Health, began using the test with his patients a little under a year ago in hopes it would help him better personalize his patients' care plans.
In MS, "a lot of the data that guides us [currently] is population-based and not personalized to the patient," he said.
He cited as an example the choice of a patient's initial therapy.
"Generally speaking, the data suggests that everyone should be on high-efficacy therapy early on, but that may incur more risk for the patient, and it's not always necessary," he said. "I do have patients who do well long term not on a high-efficacy therapy, so if you can identify those patients, that would be very helpful."
Sy said that other key decision points clinicians struggle with include confidently determining when patients are failing their current medication as well as when patients can safely come off medications.
He said that he often uses the MSDA test as one of several data points when making such decisions.
"For example," he said, "with a patient who probably should be on high-efficacy therapy but is just having trouble taking that jump, I think an additional test that shows that not only have they had a lot of disease in the past, but that predicts they could have a lot of disease in the future, as well, helps the patient make that choice."
Sy, who said he has received payments from Octave for participating on company advisory boards but has no other financial interest in the firm, added that one potential advantage of the test is its ability to provide a more prospective view of patients' disease activity. Currently, he noted, many measures used to evaluate patients, such as the appearance of new lesions on an MRI, are backwards looking.
"A lot of what we do is basically too late," he said. "The [MSDA] test is more prospective looking. How much more I think remains to be seen. It's definitely more than what we are doing now, but is it early enough? I think that's still an open question."
Martin Belkin, medical director of the multiple sclerosis center at the Michigan Institute for Neurological Disorders, said his center has been using the test "fairly routinely" for roughly a year.
Belkin, who, like Sy, has been a paid member of Octave advisory boards but otherwise has no financial interest in the company, said he commonly uses the test to monitor patients, establishing baselines in newly diagnosed individuals or individuals planning changes in therapy and then following up with additional testing over time.
While he uses the MSDA test in concert with more conventional measures like MRI, Belkin said there have been occasions where an MSDA score indicated higher disease activity than suggested by other data points. He said that in certain of those patients, he has moved to more frequent monitoring — for instance, scheduling another MRI for six months out instead of a year — than he would have in the absence of the high MSDA score.
Megan Weigel, an advanced practice registered nurse at Baptist Neurology in Jacksonville Beach, Florida, likewise said that her clinic has moved to more intensive monitoring of certain patients in response to high MSDA scores.
Weigel, who has received payments for Octave for participating on an advisory board but otherwise has no financial interest in the company, said Baptist Neurology began using the test regularly in May and currently uses it in roughly 90 percent of its MS patients, testing either annually or every six months depending on their disease activity.
At the moment, Octave has the blood-based MS testing space largely to itself, with neurofilament-light chain (NfL) as the only other blood-based biomarker in clinical use for monitoring MS disease activity. High-sensitivity immunoassay firm Quanterix is the primary provider of NfL testing. NfL is also a component of the MSDA test, where it is run on Olink's technology.
Belkin and Weigel both said they don't typically order standalone NfL testing given that an NfL result is included as part of the Octave test along with measures for the 17 other markers. Sy said he still orders standalone NfL, in part to determine how well results from the Quanterix assay and Octave's Olink-based assay correlate.
"So far, it has been good," he said. "I may stop at some point, but for now I'm continuing to validate" the concordance of the two assays.
Octave continues to generate data supporting the test. At the recent MSMilan2023, the Joint ECTRIMS-ACTRIMS annual meeting, the company presented several posters looking at the performance of the test including for predicting disease activity as measured by MRI and tracking the response of patients to the anti-CD20 monoclonal antibody agent ublituximab (TG Therapeutics' Briumvi).
In September, Octave announced it will be conducting an observational study sponsored by Biogen that will use the company's MS management tools, including use of the MSDA test to compare disease activity in individuals with relapsing MS treated with one of three different therapies.
Sy highlighted a number of areas where he would be interested in seeing more data around the test, including more longitudinal data on its ability to predict patient relapses and disease progression as well as additional studies to assess the test's usefulness for identifying patients who can safely de-escalate treatment.
Octave is also working to secure payor coverage for the test, Hagstrom said. The company is pursuing two approaches to payor coverage — standard fee-for-service contracts and value-based care contracts.
Hagstrom said Octave recently closed its first fee-for-service contract and is in the process of finalizing another two. He added that the company is "getting very close" to its first value-based care contract.
Initially, Hagstrom said, the company's value-based care deals will be based on per-member per-month billing models wherein insurers will pay a fixed monthly rate per covered individual. Longer term, Octave aims to go at-risk for a percentage of its fees, meaning that it will be paid based in part on the amount of money it is able to save insurers on treatment and management of their MS patients.
"As we gain experience and understand the disease and its management drivers more sufficiently, there is the opportunity to go from [billing] $2,000 or $3,000 per patient per year to [billing] some percentage of the ultimate $65,000 per patient per year that is spent on this population," he said.
In addition to clinicians, Octave is targeting the test to pharma firms as a tool for their MS drug development efforts. In addition to the Biogen work, the company has used its test for studies with TG Therapeutics and is involved in discussions with three or four other pharma firms, Hagstrom said. He cited the recent emergence of bruton tyrosine kinase (BTK) inhibitors as MS drugs as an opportunity for the company.
"There are four to five BTK inhibitors coming to market, each with their own subtleties, nuances … all of which may be candidates for some kind of differentiation," he said.
Hagstrom said that Octave, which closed a $30 million extension to its Series B funding round in July and has raised a total of $78.5 million in funding total, also plans to move into other neurodegenerative diseases like Parkinson's and Alzheimer's. He said the company will in coming weeks announce its first move into a condition beyond MS.