ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2025
Clinical validation of a novel in vitro diagnostic neurofilament light chain assay for the prognostication of disease activity in people with relapsing multiple sclerosis.
Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Bayes at the Bedside: Biomarkers in Situations of Clinical Uncertainty.Diagnostics (Basel, Switzerland) · 2026Article
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNeurofilament light chain (NfL) is a promising marker for predicting disease activity in relapsing multiple sclerosis (RMS). To date, however, there has been no commercially available NfL assay validated in MS and intended for routine clinical use.
objectiveTo identify and validate a single threshold for NfL in blood that differentiates RMS patients, aged 18-55 years, at a higher versus lower risk of disease activity over 2 years, using the Atellica
methodsThe optimal NfL threshold for this assay/use case was identified and independently validated using ASCLEPIOS I and II data, respectively. The primary endpoint (annualized number of new/enlarging T2 (neT2) lesions) was analyzed using negative binomial models. Threshold optimization used maximum likelihood methodology. Generalizability analyses used data from ASCLEPIOS II, FREEDOMS, and TRANSFORMS.
resultsNfL concentration of 12.9 pg/mL was validated as the optimal cutoff for prognosticating disease activity as measured by neT2 lesion over 2 years. This threshold prognosticated individual patient risk for persistent disease activity (>3 neT2 lesions/year over 2 years) and showed prognostic value across relevant subgroups and clinical scenarios. Findings for relapses were similar.
conclusionThe CE-marked Atellica
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