Clinical validation of a disease activity panel for multiple sclerosis


The heterogenous variations in the clinical disease course of multiple sclerosis (MS) make diagnosis and prognosis difficult. This has resulted in an unmet need for clinically validated, quantitative serum-based tests that can accurately monitor MS disease activity and progression. A team from the Brigham and Women’s Hospital at Harvard Medical School have reported the outcome of a study to clinically validate a multi-protein panel for monitoring disease activity in MS patients. The Multiple Sclerosis Disease Activity (MSDA) panel, based on Olink® Proximity Extension Assay (PEA) technology and developed by Octave Bioscience has previously gone through a technical validation (Qureshi et al., 2023, Proteomics Clinical Applications). In the present study, the MSDA panel was validated from the clinical perspective using 614 serum samples from two independent sources (SUMMIT & RMMSC) by evaluating the associations of protein levels with the overall DA score and four disease pathway scores, based on a composite of radiographic and clinical evidence.


The protein model was trained based on presence/absence of gadolinium-positive (Gd+) lesions (indicators of disease severity) and was also strongly associated with emergence of new lesions, and overall disease activity (radiographic and clinical evidence). Patients with a high MSDA score were ~21x more likely to have 2 or more Gd+ lesions than those with a low/moderate DA score, and ~4.5x more likely to have 1 or more Gd+ lesions compared to patients with a moderate/high MSDA score. The panel outperformed the top-performing single-protein model (neurofilament light)  – for example when comparing active vs stable disease, the MSDA model had an AUC=0.768 compared to 0.683 for Nfl alone. The authors concluded that the MSDA Test was clinically validated and can serve as a quantitative tool to enhance the care of MS patients.



Chitnis T, Foley J, Ionete C, et al. Clinical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis. (2023) Clinical Immunology, DOI: 10.1016/j.clim.2023.109688

The multi-protein model had significantly greater performance compared with the top-performing single-protein model based on demographically corrected NfL in all assessments. The MSDA Test is intended to complement standard radiographic imaging and clinical assessment and promote individualized disease management

Chitnis et al. (2023)

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Olink’s Proximity Extension Assay (PEA) technology has been used for protein biomarker discovery and analysis across a very broad range of disease areas and applications, providing actionable insights into disease biology and helping to drive future development of new and better therapeutics. There are now well over 1000 publications citing the use of our assays and the list is growing rapidly. Please visit our library of publications to see some of the extraordinary work produced by Olink customers.

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