Octave Presents Clinical Validation Results of its Multivariate Blood-based Multiple Sclerosis Disease Activity Biomarker Test at ACTRIMS Forum 2022
Data shows multivariate test is highly associated with multiple Disease Activity endpoints and is significantly superior to the top performing univariate biomarker
Company’s first-of-its-kind Precision Care Solution addresses the complex unmet needs of multiple sclerosis and other neurodegenerative diseases
MENLO PARK, Calif.–(BUSINESS WIRE)–Octave, the developer of a fully-integrated Precision Care Solution built to deliver comprehensive insights that bring scientific clarity to multiple sclerosis (MS), today announced the presentation of data based on eight posters at the ACTRIMS Forum 2022. The posters collectively support the upcoming launch of the company’s Precision Care Solution, with seven of the posters focused on the company’s novel MS Disease Activity (MSDA) test including clinical validation study results and independent cohort replication.
“We are continuously working to dramatically improve outcomes for patients with MS and other neurodegenerative diseases, and believe that to improve management of these diseases, we must first improve measurement,” said William Hagstrom, Founder and Chief Executive Officer of Octave. “Our biomarker blood test measures the patient’s disease biology to reveal underlying activated pathways and mechanisms, including the quantitative analysis of serum proteins to create unique MS signatures. We are thrilled that the data presented at ACTRIMS 2022 clinically validates the MSDA test as there is an acute need to better characterize patients’ underlying biology in clinical practice and optimize their treatment.”
Octave’s data at ACTRIMS 2022 showed in multiple studies that the test can serve as a quantitative and objective tool to enhance the care of MS patients in contrast to the current standard of care that relies on qualitative radiographic and subjective clinical assessments. Specific highlights include:
- P018 – Clinical Validation Study Results for a Multivariate Proteomic MS Disease Activity Test (Chitnis, T., et al.) evaluated the company’s custom, multivariate immunoassay panel that measures the concentrations of 18 proteins representing four primary pathways involved in MS pathophysiology. Results showed that the multivariate model was significantly superior to the top performing univariate biomarker. Furthermore, odds ratios were determined relative to the three established Disease Activity (DA) categorizations (Low, Moderate, and High) which indicated that a patient with a Moderate or High score is 5.10 times more likely to have one or more Gadolinium (Gd) lesions than a patient with a Low score, and a patient with a High score is 15.79 times more likely to have two or more Gd lesions than a patient with a Low or Moderate score.
- P045 – Multivariate Proteomic MS Disease Activity Test Score Performance Evaluated in an Independent Focal Inflammation Cohort (Kuhle, J., et al.), conducted internationally on samples from the University Hospital Basel, showed that the validated algorithm used to produce the results of the MSDA test demonstrates strong replication in an independent post-validation cohort for all metrics (sensitivity, negative predictive value, accuracy, and odds ratios) that were used to establish the score thresholds corresponding to Low, Moderate, and High DA categories for MS. Consistent with odds ratios observed in the clinical validation study (P018), in this independent analysis a patient with a Moderate or High score was 5.56 times more likely to have one or more Gd lesions than a patient with a Low score, and a patient with a High score was 11.44 times more likely to have two or more Gd lesions than a patient with a Low or Moderate score.
- P043 – Multivariate Proteomic MS Disease Activity Test Result Distributions Based on Disease Modifying Therapy Categories (Chitnis, T., et al.) assessed the effect of MS therapies that have diverse mechanisms of action (MOA) relative to the individual biomarkers and algorithmic scores reported from the MSDA test. The data presented suggest that the test could reflect therapeutic efficacy and could be characterized further relative to the biological impact of various therapy MOAs. The company plans to expand the analysis with additional studies and endpoints.
- P029 – Estimation of Disability Status from Blood Serum Protein Concentrations (Chitnis, T., et al.) displayed promising initial results for the correlation of several proteins with disability status as measured by Expanded Disability Status Scale/Patient Determined Disease Steps. These are key indicators of MS disability status that the multivariate test and more quantitative datapoints could supplement in order to deliver a more holistic and accurate view of an MS patient’s state. Additional studies specifically designed to evaluate disability status and disease progression relative to ~3,000 protein biomarkers are currently underway.
- P006 – Analytical Validation of the Disease Activity Score and 4 Disease Pathway Scores for a Multivariate Proteomic Multiple Sclerosis Disease Activity Test (Hu, W., et al.) outlined how the DA and Pathway scores from the MSDA test were found to be accurate, precise, robust and stable for sample processing and storage expected in real world clinical conditions.
- P008 – Association Between Serum Biomarkers and Patient-Reported Outcome of Disability in Multiple Sclerosis (Zhu, W., et al.) highlighted that the addition of serum protein biomarkers included on the MSDA test assay panel to key clinical features improves the performance of predictive models of patient-reported MS disability status.
- P044 – Multivariate Proteomic MS Disease Activity Test Results Surfaces Both Individual Patient and Clinical Practice Population Insights (Qureshi, F., et al.) explored the MSDA test’s observed score distributions in a well-controlled population of patients with MS, and showed that in a population of 222 patients, results from the test serve as a quantitative tool to evaluate not only an individual patient’s level of DA, but to effectively monitor the overall level of DA within a clinic’s entire population.
Additionally, Octave presented a poster titled P216 – Accounting for Variance in Brain Atrophy Measurements by Quantifying Image Quality Differences Across Longitudinal Imaging Studies (Crowley, RJ., et al.) which aimed to create a single metric to quantify image quality differences to aid atrophy measurements. Across 480 MS patients, Octave demonstrated success in creating a single measure to quantify image quality differences over time.
The posters presented by Octave at the ACTRIMS Forum 2022 underscore the company’s dedication to the pursuit of clinical insight and to addressing the various unmet needs associated with MS as it builds the model for the future of MS management. Octave is actively developing novel measurement tools that feed structured analytical data models to improve patient management decisions, create better outcomes, and lower costs, ultimately benefitting patients, their physicians, and the entire health care system.
About Multiple Sclerosis
MS is a chronic, lifelong, debilitating disease that affects approximately three million patients globally (one million of whom are in the US), affecting people as early as in their 20’s with a 3:1 prevalence in women. The disease is driven by autoimmune and inflammatory processes as well as neurodegeneration, including demyelination and axonal damage. Estimated lifetime cost of MS is more than $4 million per patient and the estimated total cost in the US is $28 billion every year.1 MS is ranked second, behind only congestive heart failure, in direct all-cause medical costs. While there are now more than 22 approved treatments called disease modifying treatments, drug prices have continued to rise, costing between $60,000 and $100,000 per year.2
About the Octave’s Comprehensive Precision Care Solution
Octave’s Fully-Integrated Precision Care Solution provides a quantitative, objective measurement system designed to expand clinical insights in neurodegenerative disease, beginning with MS. It provides multiple dimensions of insight to reveal a 360-degree view with a longitudinal perspective of a patient. The first dimension measures the patient’s underlying biology with blood-based biomarkers that quantitatively and objectively assess inflammation, immune modulation, exonal damage, and demyelination. The second dimension includes advanced measurement using improved MRI readings and interpretation to reveal more insights at the CNS layer, including the brain and spine. The final dimension features real-time tracking of symptoms via mobile tools, sensors and wearables to identify changes in disease, and alert to care teams. All of this data is integrated into protocols, supported by decision support tools and feeds into a dashboard for ease of use. The Octave Precision Care Solution allows individual and population level views to facilitate better stratification and contextual interventions.
About Octave
Octave was founded to deliver a fully-integrated Precision Care Solution for multiple sclerosis as well as a full range of neurodegenerative diseases. Its comprehensive insights provide neurologists and their patients with objective metrics to facilitate informed care and shared decision making for better patient outcomes. Octave is headquartered in Menlo Park, California.
- Optum.com, “Six Cost Drivers of Multiple Sclerosis”
- J.Med Econ.2013; 16(5):639-47
Contacts
Terri Clevenger
Westwicke/ICR Healthcare PR
Tel: 203.856.4326
Terri.Clevenger@icrinc.com