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.
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.
According to the company, 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.
Key findings from the paper conclude that the test can serve as a quantitative tool to enhance the care of MS patients. Currently, it is commercially available and in routine clinical use within practices across the United States as well as in pharmaceutical studies.
Ferhan Qureshi, vice president of biomarker product development at Octave, said: “The data published in this study represent a major advancement in providing deeper insights for the MS community. 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.”
Tanuja Chitnis, principal investigator on the paper, added: “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. 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.”