Real-world clinical utility of a multi-protein, blood-based biomarker assay for disease activity assessments in multiple sclerosis
Multiple Sclerosis Journal – Experimental, Translational and Clinical, 2025
Sanchez A., Sheng E., Eagleman S., Eubanks J., Izbicki P., McCurdy S., Burrill M., Qureshi F., Ghoreyshi A., Williams M., Weigel M., Kilgo W., Nicholas J., Okai A., Belkin M., Burnham J., Jassam Y., Sy M., Gonyou T.
| Disease area | Application area | Sample type | Products |
|---|---|---|---|
Neurology | Patient Stratification | Plasma |  Olink Focus |
Abstract
Background
Blood-based biomarkers have emerged as promising tools to optimize treatment decisions in multiple sclerosis (MS) including initiation, switch, or cessation of disease modifying therapies.
Objectives
The clinically validated MS disease activity (MSDA) test measures 18 proteins to derive a disease activity score. This study tests the clinical utility of MSDA in real-world practice.
Methods
Twenty clinicians from 14 clinics conducted a chart review utilizing a retrospective, longitudinal design, with a pre-post component. Chart reviews captured clinician decision-making before and after receipt of each MSDA result, while separate clinician assessments also captured the perceived impact of MSDA on MS management.
Results
A total of 352 charts were reviewed. The overall rate of clinical decision changes after MSDA testing (19.4%) exceeded predefined benchmarks. The proportion of patient time points where clinicians “strongly agreed” or “agreed” that MSDA results influenced their decision-making was greater when multiple longitudinal MSDA results were available compared to a single result: 69.2% (95%CI: [60.2%, 78.3%) vs. 59.8% (95%CI: [43.7%, 76.0%]), respectively.
Conclusion
When used in addition to standard of care, MSDA demonstrates clinical utility for real-world decision-making in MS management, based on objective changes in treatment plan and clinician – reported impact, which increases with longitudinal use.