Octave Bioscience has announced significant advancements for its Multiple Sclerosis Disease Activity (MSDA) Test, with new clinical utility data and expanded nationwide availability. The test, which measures 18 proteins to assess disease activity in multiple sclerosis patients, is demonstrating meaningful impact on treatment decisions in real-world clinical settings.
A study published in Multiple Sclerosis Journal – Experimental, Translational and Clinical evaluated the test's influence on clinical decision-making across diverse MS care settings. Researchers examined 352 patient charts reviewed by 20 clinicians across 14 sites, analyzing 723 MSDA Test results.
The findings revealed that a single MSDA Test influenced MS management decisions in 59.8% of cases, with that influence increasing to 69.2% when multiple, longitudinal test results were available. Notably, nearly one in five (19.4%) test results led clinicians to adjust their MS management approach.
Real-World Clinical Impact
Dr. Taylor Gonyou, lead investigator and neurologist at the Michigan Institute for Neurological Disorders (MIND), highlighted the test's value in addressing a critical challenge in MS care.
"One of the biggest challenges in MS management is determining when to adjust treatment," said Dr. Gonyou. "This study demonstrates that integrating multi-analyte biomarker data from the Octave MSDA Test into clinical workflows enhances decision-making, particularly with repeated use, as confidence in the MSDA Test grows over time."
The study identified three primary patterns in how the test influenced clinical management:
- Low MSDA Test scores supported clinicians' plans to continue current treatment
- Low scores also influenced decisions to discontinue disease-modifying therapies (DMTs)
- High scores led clinicians to initiate or switch DMTs
Dr. Jennifer Graves, Senior Medical Advisor at Octave and Professor of Neurosciences at UC San Diego, emphasized the critical gap being addressed by the test: "Clinicians need more than traditional imaging and symptom tracking to assess disease activity effectively. Protein biomarkers have the potential to fill this gap."
Nationwide Availability
In a separate announcement, Octave Bioscience revealed that the MSDA Test has received certification from the New York State Clinical Laboratory Evaluation Program (CLEP), known for maintaining the highest quality standards in the U.S. This certification completes the test's nationwide availability, making it accessible in all 50 states.
The test is performed in Octave's Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathology (CAP) accredited laboratory. Since 2022, it has been used by leading MS Centers of Excellence, academic institutions, and independent neurology practices across the United States.
Advancing Precision Care in MS
Doug Biehn, CEO of Octave, emphasized the company's mission: "Our goal is to empower both providers and patients with precision tools that transform MS care. The study clearly demonstrates that the MSDA Test is a precision tool that provides physicians with clinically actionable data, enabling more targeted treatment decisions and helping support disease stability in real time."
The test's AI-enabled analysis delivers individualized, real-time reports that can guide disease management decisions. Physicians can implement the test at any point in a patient's MS journey, even years after disease onset and diagnosis.
Dr. Bianca Weinstock-Guttman, SUNY Distinguished Professor at the University at Buffalo, noted the test's potential to transform MS care: "Given the heterogeneity of MS, having the ability to look beyond the clinical exam and incorporate an individual's measured disease activity will allow us to focus on managing the needs of each patient. The MSDA Test has the potential to redefine clinical care for MS patients today and well into the future."
Patient Perspective
Stephanie Buxhoeveden, Chief Scientific Officer at Accelerated Cure Project for Multiple Sclerosis, offered a unique perspective as both a clinician and MS patient: "As a clinician, researcher, advocate and MS patient, I live the challenges of managing MS. The MSDA Test has given me invaluable insights that helped me navigate my own disease while also providing tremendous peace of mind."
The Octave MSDA Test represents a significant advancement in objective biomarker assessment for MS, potentially establishing a new standard of care that combines traditional clinical evaluation with quantitative disease activity measurement to optimize treatment decisions and improve patient outcomes.
