Qureshi et al Biomarker Analytical Validation Manuscript MedRxiv 1 Analytical validation of a multivariate proteomic serum-based assay for disease activity assessments in multiple sclerosis Ferhan Qureshi, 1 * Wayne Hu, 1 * Louisa Loh, 1 Hemali Patel, 1 Maaria DeGuzman, 1 Michael Becich, 1† Fatima Rubio da Costa, 1 Victor Gehman, 1 Fujun Zhang, 1 John Foley, 2 Tanuja Chitnis 3 1 Octave Bioscience, Inc., Menlo Park, CA, USA 2 Rocky Mountain Multiple Sclerosis Clinic, Salt Lake City, UT, USA 3 Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA *These authors contributed equally to this work † Employee of Octave Bioscience, Inc. at the time the study was completed Correspondence Ferhan Qureshi 1440 Obrien Drive, Suite B Menlo Park, CA 94025, USA Email: fqureshi@octavebio.com Phone: 650-224-3072 Fax: 650-479-8876 Abbreviations: %CV, percent coefficient of variation; APLPL1, amyloid beta precursor-like protein 1; CCL20, C-C motif chemokine ligand 20; CD6, cluster of differentiation 6; CDCP1, CUB domain-containing protein 1; Cmax, maximum concentration; CNS, central nervous system, CNTN2, contactin 2; COL4A1, collagen type IV alpha-1; conc, concentration; CSF, cerebrospinal fluid; CXCL9, chemokine (C-X-C motif) ligand 9 (MIG); CXCL13, chemokine (C-X-C motif) ligand 13; DMT, disease-modifying therapy; DNA, deoxyribonucleic acid; FLRT2, fibronectin leucine-rich repeat transmembrane protein; GFAP, glial fibrillary acidic protein; GH, growth hormone; HAMA, human anti-mouse antibodies; HCl, hydrochloride; IL-12β, interleukin-12 subunit beta; LLOQ, lower limit of quantitation; LOQ, limit of quantitation; mAb, monoclonal antibody; Max, maximum; Min, minimum; MOG, myelin oligodendrocyte All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 25, 2022. ; https://doi.org/10.1101/2022.05.23.22275201 doi: medRxiv preprint NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.