ACTRIMS 2022 | Clinical validation of the MSDA test

Ferhan Qureshi, BS, Vice President, Octave Bioscience, Menlo Park, CA, discusses a clinical validation study following the initial analytical validation study of eighteen proteins for the multivariate proteomic multiple sclerosis disease activity (MSDA) test presented at ATCRIMS 2021. Mr. Qureshi describes the parameters of the most recent study, whereby access to 617 samples from four different sites was obtained. Three sites were retrospective, and one site was prospective: the Brigham & Women’s Hospital, the American University of Beirut, the University of Massachusetts, and the Rocky Mountain MS Clinic in Utah, respectively. The 617 samples were then split into a training and test model. The final model was optimized in the training set – being further tested by a statistician for performance relative to three disease activity endpoints. These endpoints were described as: the presence of gadolinium-enhancing lesions, new and enlarging T2 lesions, and clinically defined relapse status. This test was shown to be significantly associated with each of the disease activity endpoints stated, and even superior to neurofilament light (NfL) – the current top-performing univariate biomarker. This interview took place at the ACTRIMS Forum 2022 in West Palm Beach, Florida.