Doug Biehn says he thrives on solving big problems with an impact on outcomes and cost. To do just that, Biehn joined San Francisco-based Octave Bioscience as CEO last November to lead the commercialization of the firm’s diagnostic test for detecting multiple sclerosis (MS) disease activity and other neurogenerative disease.
“With neurodegenerative diseases, there are really acutely important problems to solve, and they have a huge economic burden,” Biehn told Medtech Insight during an interview at the HLTH conference in Las Vegas last month. “In the US alone, there are 1 million people diagnosed with multiple sclerosis driving an $85bn economic burden per year. Not only is it a disabling disease, it is a very expensive disease.” He added that Parkinson’s disease, for which Octave is also developing a diagnostic, is very similar in terms of prevalence and cost burden.
What makes Octave’s multivariate biomarker blood test unique, according to Biehn, is that it isn’t just looking at one biomarker such as neurofilament light chain (NfL), which is one of the most studied biomarkers of disease activity and treatment response in patients with MS.
Rather, Octave has focused on deriving key insights from multi-modal data to develop its MS disease activity (MSDA) test, a custom proteomics panel of 20 sensitive biomarkers that can predict key clinical and radiographic signs of disease activity in MS.
Key Takeaways
- Octave’s MSDA test, a multi-biomarker blood test, delivers a comprehensive disease activity score that helps clinicians manage their patients’ MS more effectively by tracking disease activity and optimizing treatments.
- Octave’s target market is the 10,000 general neurologists in the US, about 200 of whom currently prescribe MSDA.
- Leveraging a $10m grant from the Michael J. Fox Foundation, Octave is developing a similar blood-based biomarker panel for Parkinson’s disease. They aim for clinical validation in 2026.
Octave’s researchers used data from MS clinical trials, including CLIMB from Brigham and Women’s Hospital and EPIC from the University of California, San Francisco, as well as the Accelerated Cure Project Biorepository, to look for biomarkers linked to disease activity. The project involved analyzing more than 1,400 proteins in 630 samples from three different groups of MS patients, the company said.
Octave’s research showed that multiple proteins with diverse biological functions were associated with MS endpoints of disease activity and that multi-protein models have stronger associations than any single protein models. This suggests that a comprehensive, multianalyte approach like Octave’s MSDA test can better characterize disease activity in MS patients, Octave said.
The company’s research on the MSDA test, which Biehn described as the world’s first clinically validated multivariate blood test measuring MS activity, was published in Nature Communications on 20 May.
“What we have done that no one else has done is we’ve been able to identify the specific biomarkers that characterize disease,” Biehn explained. “There are 18 biomarkers that are mostly associated with characterizing the activity of a patient with MS. We apply a very unique artificial intelligence application on top of those 18 biomarkers that derives what’s called a disease activity score.”
The derived score of 1 to 10 will tell the clinician if the patient’s MS is “in or out of control,” he said. If the MS activity is out of control, it means there is a high probability of a potentially devastating high magnitude event.
“An event isn’t a nominal thing – [MS patients] go blind, they become disabled,” Biehn said. MS is the most common neurodegenerative disease among young adults ages 20 to 40 and impacts mostly women.
Clinicians who use the MSDA test are armed with objective, predictive biologic data, which helps them to choose the optimal treatment for each patient from among the 25 disease-modifying therapies available, Biehn said. The information, he added, lets clinicians ensure “the patient is on the right drug at the right time.”
Typically, Biehn explained, clinicians using MSDA begin by doing a baseline test before changing a patient’s treatment regime. They then check the results after about three months. If the new treatment is successful in keeping MS under control, the test will be redone after a further six months. Each patient is typically tested two to three times per year, he said,
Biehn noted that Octave has contracts with several pharmaceutical companies in the MS space, including Novartis, Biogen and TG Therapeutics.
“We even have some very interesting, published evidence these pharmaceutical companies use our test to make sure their drugs are working,” he said.
That said, Biehn noted that MSDA is not a companion diagnostic tethered to a specific drug. Rather, its focus is to provide “personalized treatment” to understand where the patient is in their disease stage to ensure they are getting the right treatment. For example, it can let clinicians know if a drug seems to be doing more harm than good and should be switched out or discontinued.
While current MS drugs can reduce the likelihood of relapses and events, they are not effective at changing the progression of the disease. Biehn said that drug makers are working on next-generation drugs that will be able to change the progression of the disease. In recent years, drug makers have made significant progress in slowing the progression of Alzheimer’s disease in some patients. “So where Alzheimer’s basically is [today] is where MS wants to go,” he explained.
CLIA-Certified
The MSDA test is CLIA-certified and CAP-certified (accredited by the College of American Pathologists) meaning it meets lab testing quality standards in the US, Biehn said. MSDA also meets European standards for patient data privacy and is compliant with HITRUST, an international cybersecurity standard.
There is also a reimbursement pathway available. Biehn said that MSDA is covered by several health plans, including Blue Cross, Blue Shield of Illinois and Michigan and CareFirst.
MSDA is used at 50% of the top 20 academic excellence centers for MS. Among Octave’s target market of general neurologists, more than 200 are prescribing the test already.
“There are 10,000 general neurologists in the country,” Biehn said, allowing ample opportunity to get the test in more neurologists’ hands.
The test will not be affected by most provisions of the US Food and Drug Administration’s recent rule on the regulation of lab-developed tests because it was created before the rule, Biehn said.
Parkinson’s Disease
The company is also working on developing and validating a new biomarker panel to measure Parkinson’s disease activity. Last November, the Michael J. Fox Foundation of Parkinson’s Research (MJFF) awarded Octave a $10m grant to put its knowledge to work for Parkinson’s patients.
“There are 60 different drugs right now in development for Parkinson’s and we would be first to really quantify their efficacy,” Biehn said.
In 2023, the MJFF announced that it had validated a Parkinson’s disease biomarker that uses a tool called the alpha-synuclein seeding amplification assay (SAA) to detect abnormal clumping of alpha-synuclein, a key pathology in most cases of Parkinson’s, the Foundation reported. But SAA has limitations. Currently it can only be validated in spinal fluid, which is difficult to obtain. And as a binary test, it either gives a positive or negative reading, not showing the degree of activity.
“Building on Octave’s progress in multiple sclerosis, we are thrilled to work with MJFF to build a precision care solution for Parkinson’s,” Jim Eubanks, Octave’s global director, medical affairs and investigator of the project, said in a statement from last November.
“With Parkinson’s you have movement disorder specialists to deal with central tremor and action tremor patients and with MS, you have MS specialists, but it’s the general neurologists that sees the vast majority of MS and Parkinson’s patients,” Biehn noted. He expects that Octave will have a blood test for analyzing Parkinson’s disease progression in clinical validation studies in 2026. He pointed to another value-add.
“I think the test will also accelerate drug discovery and make sure we’re bringing the most efficacious drugs to patients,” he said.
To date, Octave has raised about $100m in total funding. He considered HLTH a great venue for meeting with investors. He’s trying to raise a series C fund-raising round, which, he said, will get Octave to the next inflection point. “It’s all growth capital we are seeking.”
Neurology and neurodegenerative diseases is where cancer was 20 years ago, Biehn said.
“If you look at the innovation in cancer, it’s been incredible,” he said. “If you think of the size and magnitude of the neurodegenerative market and the aging population, the health care system is stuck in Medicine 2.0.”
He feels that the tools clinicians use are antiquated and rely on patients’ symptoms. “If you’re waiting for a patient to have symptoms in Alzheimer’s or Parkinson’s or MS it’s too late,” he said.