New Independent Study Establishes the Octave MSDA Test as an Objective Measure to Distinguish True MS Relapse from Pseudoexacerbation

The study shows the MSDA Test delivers an objective, quantifiable measure of inflammatory disease activity to distinguish true relapse from pseudoexacerbation, a common challenge in today’s standard of care, and outperforms neurofilament light (NfL) alone.

MENLO PARK, Calif.--(BUSINESS WIRE)--Octave Bioscience, Inc., a commercial-stage precision neurology company pioneering a new standard for managing multiple sclerosis (MS) and other neurodegenerative diseases such as Parkinson’s disease, today announced publication of an independent, investigator-initiated study in the journal Neurology and Therapy evaluating the Octave^® Multiple Sclerosis Disease Activity (MSDA) Test in one of the most consequential judgment calls in MS care, whether a patient’s new or worsening symptoms reflect a true inflammatory relapse or a pseudoexacerbation.

Entitled Utility of Multi-Analyte Protein Assay to Distinguish Multiple Sclerosis Clinical Relapse from Pseudoexacerbation, the retrospective observational study enrolled 66 people with relapsing multiple sclerosis at a single academic medical center. Researchers compared blood-based MSDA Test Disease Activity Scores with MRI findings to evaluate the test’s ability to distinguish true inflammatory relapse from pseudoexacerbation. MRI evidence of gadolinium-enhancing lesions served as the reference standard for active inflammatory disease, and investigators also compared the performance of the multi-protein MSDA Test with neurofilament light chain (NfL), a commonly studied biomarker of neuronal injury.

Key findings from the study:

• Objective accuracy: The MSDA Disease Activity Score identified MRI-confirmed active inflammatory disease with 100% sensitivity, 94% specificity, and a 100% negative predictive value, and outperformed neurofilament light (AUC 98.1% vs. 82.8%).
• Confident decisions: The test provides objective, quantifiable data to help clinicians determine when MRI or corticosteroid treatment is warranted.
• Timely insight: In acute cases, the test was obtained before MRI 79% of the time, offering earlier biological insight when decisions are time-sensitive.

"One of the greatest challenges in multiple sclerosis care is determining whether new or worsening symptoms reflect active inflammatory disease or a pseudoexacerbation," said Darin T. Okuda, M.D., Professor of Neurology and Director of the Neuroinnovation Program and the Multiple Sclerosis and Neuroimmunology Imaging Program at The University of Texas Southwestern Medical Center and lead author of the study. "These findings suggest that the MSDA Test may provide clinicians with additional objective information to complement clinical evaluation and MRI when assessing patients presenting with new symptoms. While additional prospective studies are warranted, this research represents an important step toward more informed clinical decision-making."

“What’s particularly encouraging is how the evidence supporting blood-based biomarkers in multiple sclerosis continues to evolve. Earlier this year, data presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting demonstrated how the MSDA Test is being incorporated into routine clinical practice across hundreds of providers and institutions,” said Terrie Livingston, Vice President Medical Affairs, Octave Bioscience. “Understanding the biology underlying each patient’s disease is essential to managing MS well, and blood-based biomarkers are making that biology measurable in everyday practice. Evidence like this moves the field closer to care guided by a clear, objective picture of what a patient’s disease is doing, so the right clinical decisions can be made at the right time for the people who depend on them.”

For the nearly one million Americans living with MS, more objective, timely answers mean less uncertainty at the moments that matter most and more confident, biology-informed decisions between patients and their clinicians.

The Octave MSDA Test is the first and only commercially available blood test that measures 18 validated protein biomarkers designed specifically for multiple sclerosis disease activity. Providers can order the test, and patients can visit any of the 7,000 Quest Diagnostics locations nationwide for a simple blood draw. The test is reimbursed by health insurance, with financial assistance available to patients. The MSDA Test is performed at Octave's CLIA-certified, CAP-accredited, and New York State CLEP-approved laboratory in Menlo Park, California.

About Octave Bioscience, Inc.

Octave Bioscience, Inc. is a leading precision care company pioneering multi-analyte biomarker-driven solutions for neurodegenerative diseases, starting with multiple sclerosis. Octave’s comprehensive solution provides objective, actionable insights to improve disease monitoring, treatment decisions, and patient outcomes. The company’s flagship product, the Octave Multiple Sclerosis Disease Activity (MSDA) Test, is the first clinically and analytically validated blood-based biomarker test that enables physicians to quantitatively measure MS disease activity, allowing for more informed treatment decisions and personalized disease management over time. For more information, visit www.octavebio.com.