Octave® Bioscience, Inc. Announces Publication of Clinical Validation Study Results of its Novel, Multivariate Multiple Sclerosis Disease Activity (MSDA) Blood Test

•  Study published in peer-reviewed Clinical Immunology reports successful clinical validation of the Octave^® MSDA Test and demonstrates that it can serve as a quantitative tool to enhance the care of MS patients with data showcasing superior performance compared to the top-performing single-protein model.
• Validation of this commercially-available test supports ongoing and future evaluations in larger populations as well as real-world settings.
• The Octave MSDA Test addresses the critical unmet need for objective measurement for better MS management.

Octave^® Bioscience, Inc., a leading precision care company focused on delivering a new standard of care for multiple sclerosis (MS) and other neurodegenerative diseases, today announced the publication of the successful clinical validation of the Octave^® Multiple Sclerosis Disease Activity (MSDA) Test in the peer-reviewed journal Clinical Immunology.

“This research supports a validated multivariate blood test that correlates with new MRI lesions in MS patients, and can allow for improved monitoring of disease activity,” said Tanuja Chitnis, MD, Director of the Mass General Brigham Pediatric MS Center and principal investigator on the paper. “The clinical validation of this test is a meaningful step forward for the providers and researchers working to glean a more complete understanding of a patient’s MS and how the disease can vary between individuals.”

Addressing a Critical Unmet Need

MS is a complex disease with significant heterogeneity, affecting all patients differently and making diagnosis and prognosis difficult. The ongoing management of disease activity – the occurrence of new neurological symptoms and the rate of relapses – is a central theme of improving outcomes. Historically, however, there have been no dynamic, quantitative tools to measure disease activity over time. This leads to challenges in the management of MS and potential suboptimal use of disease modifying therapies, which are crucial to lower disease activity levels, reduce the number of relapses and slow the progression of disease.

To address this unmet need, Octave evaluated more than 1,400 protein biomarkers in over 3,000 patient samples and utilized advanced data science, machine learning, and feature extraction techniques to select the 18 highest performing and most relevant biomarkers for inclusion in a custom assay panel built using the Olink^® proteomics platform. The biomarkers from the panel were then integrated into an algorithm, which generates four pathway scores representing distinct disease processes in MS pathophysiology – immunomodulation, neuroinflammation, myelin biology, and neuroaxonal integrity. Additionally, the algorithm reports an overall disease activity score on a scale of 1.0-10.0.

Octave MSDA Test

Created to address this unmet need, the Octave MSDA Test is the first and only multi-protein serum-based biomarker assay designed to quantitatively measure the disease activity of patients with MS. The test can be used throughout the course of a patient’s disease to enable more informed, actionable clinical decisions that will help with better disease management. Octave’s MSDA Test is part of the Octave^® Precision Care Solution, which combines insights from the test along with expanded imaging capabilities and clinical insights to create a more holistic picture of the patient. This solution provides the entire MS care ecosystem with the tools needed to better measure, monitor, and manage the disease.

Clinical Validation of the Octave MSDA Test

The clinical validation of the test was published in Clinical Immunology in a paper titled, “Clinical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis.” The objective of the study was to clinically validate the Octave MSDA Test by evaluating the associations of the overall disease activity score and the four disease pathway scores with gadolinium-positive (Gd+) lesions, new and enlarging (N/E) T2 lesions, and active or stable disease status.

“The data published in this study represent a major advancement in providing deeper insights for the MS community,” said Ferhan Qureshi, Vice President of Biomarker Product Development at Octave. “We are encouraged that these results validate the performance of the Octave MSDA Test and demonstrate its ability to quantitatively and objectively measure disease activity of patients with MS. The test interrogates multiple biological pathways important in MS pathophysiology with a diverse set of biomarkers to provide a highly sensitive, dynamic perspective of disease at the subclinical level. This provides an important complement to clinical evaluation of signs and symptoms of disease and MRI findings.”

Key findings from the paper conclude that the Octave MSDA Test can serve as a quantitative tool to enhance the care of MS patients:

• The Octave MSDA Test was clinically validated relative to radiographic and clinical endpoints of disease activity.
• The test performed significantly better compared to the top-performing single-protein model.

The Octave MSDA Test has been previously established as accurate, sensitive, precise, and robust in a series of studies presented by leading specialists at global neurology and MS scientific congresses. In addition to its analytical validation being published in the peer-reviewed Journal Proteomics Clinical Applications in early 2023. These reports provided a strong foundation for the validation of the assay.

The Octave MSDA Test has multiple clinical use cases throughout the continuum of care, including routine surveillance to better monitor disease activity, especially in patients considered to have stable disease, and to track new or worsening symptoms. It is also used as an objective assessment for treatment response, and to monitor a patient’s disease activity level once a decision is made with their clinician to de-escalate or discontinue their disease modifying treatment.

Currently, the Octave MSDA Test is commercially available and in routine clinical use within leading practices across the United States as well as in pharmaceutical studies. The Octave MSDA Test enables shared decision making between the patient and their doctor and the test complements standard radiographic imaging and clinical assessment, leading to more objective insights for improved MS care.

About Octave^® Bioscience, Inc.

Octave^® Bioscience, Inc. is a commercial stage precision-care company delivering a new paradigm of care for multiple sclerosis and other neurodegenerative diseases. Octave’s Precision Care Solution is the industry’s first set of measurement tools that accurately and objectively measure disease activity, progression, and severity, allowing for better management of complex and high-cost neurodegenerative diseases, starting with multiple sclerosis (MS). The Octave Solution includes the first and only multivariate blood test to measure MS disease activity, enhanced MRI analytics and protocols, and a clinical care program that tracks and connects patients with MS nurse practitioners in real time. By combining and analyzing multiple biological and contextual layers of data, delivering longitudinal and holistic perspectives of each patient, and revealing insights at population levels, the Octave Solution addresses unmet needs across the entire ecosystem of care, from patients and providers to pharma and payers. Octave Bioscience, Inc. is currently collaborating with leading clinics, payers, and pharma companies across the country.

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