The Only Clinically Validated Multiple Sclerosis Multi-Analyte Test Proven to Deliver Clinically Meaningful Insights Is Now Available In All 50 States
MENLO PARK, Calif.--(BUSINESS WIRE)--#Biomarkers--Octave® Bioscience, Inc., a leading precision care company that delivers a new standard for managing multiple sclerosis (MS) and other neurodegenerative diseases, announced today the Octave Multiple Sclerosis Disease Activity (MSDA) Test has received certification from the New York State Clinical Laboratory Evaluation Program (CLEP), which maintains the highest quality standards found in the U.S. The Octave MSDA Test is the first and only multi-analyte test to quantify MS disease activity to guide treatment options.
Since 2022 Octave MSDA Test has been used by leading MS Centers of Excellence, academic institutions, and independent neurology practices across the United States providing clinicians with biomarker-driven insights to redefine what is possible in MS treatment decision making. A peer-reviewed study in Multiple Sclerosis Journal – Experimental, Translational and Clinical demonstrated the clinical utility of the MSDA Test across a range of providers and confirmed its broad applicability in real-world clinical practice.
The MSDA Test is performed in Octave’s Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathology (CAP) accredited laboratory. The New York State CLEP certification brings added rigor to the regulatory standards that the Octave MSDA Test has achieved and positions Octave MSDA Test insights to become a critical part of standard-of-care for patients who are managing MS.
“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,” said Bianca Weinstock-Guttman, MD, SUNY Distinguished Professor, Department of Neurology, Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo. “The MSDA Test has the potential to redefine clinical care for MS patients today and well into the future.”
Enabled by AI (artificial intelligence) analysis, test results are delivered as individualized, real-time reports that empower disease management decisions. Physicians can begin using the test for an MS patient at any time in their journey with the disease, even years after disease onset and diagnosis.
“We are proud of our long-standing partnership with Octave Bioscience. Our collaboration enabled the demonstration of proteomic associations with clinically defined relapse in multiple sclerosis and was crucial in developing the MSDA Test,” said Stephanie Buxhoeveden, Chief Scientific Officer, Accelerated Cure Project for Multiple Sclerosis. “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 is the compass to care that we have been seeking.”
“The certification of Octave’s MSDA Test in New York State is a major milestone, not just because it means the test now is certified across the U.S. but also because New York sets the highest regulatory standards of any state for clinical laboratory tests,” said Doug Biehn, President and CEO of Octave Bioscience. “The fact that the MSDA Test has achieved this quality standard should give all U.S. physicians the greatest possible confidence in the rigor and reliability of Octave and its MSDA Test results.”
Multiple sclerosis (MS), a chronic autoimmune disorder affecting the brain and central nervous system, is a complex heterogeneous disease that affects all patients differently making clinical decision making and treatment difficult. Prior to the Octave MSDA Test, disease management in MS relied primarily on clinical assessments and MRI, which often produce conflicting results and have limited ability to objectively and quantitatively measure disease activity or treatment response over time.
About Octave Bioscience, Inc.
Octave Bioscience, Inc. is a leading precision care company pioneering 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.
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