From Biomarker Discovery to Clinical Translation - The Multiple Sclerosis Disease Activity (MSDA) Test Product Journey

The standard of care for Multiple Sclerosis (MS) patients relies heavily on assessments that are subjective, qualitative, and inadequate. To address unmet needs across the entire MS ecosystem (patients, physicians, pharma and payors), Octave Bioscience developed, validated and commercially launched the Multiple Sclerosis Disease Activity (MSDA) Test. The MSDA test quantitatively reports a patient’s level of disease activity using an algorithm incorporating 18 protein biomarkers that are measured in a blood sample. The development of the MSDA test involved biomarker discovery efforts for which over 1400 proteins were screened in several deeply phenotyped studies and associated with clinical and radiographic endpoints of disease activity. An iterative process that balanced statistical, analytical, and biological factors was then used to select proteins for inclusion into a custom assay panel that was developed using the Olink platform. Prior to clinical launch, the MSDA Test was analytically and clinically validated, and it is currently in use in nearly 100 clinics across the United States as well as being utilized in multiple retrospective and prospective clinical trials.