- CE mark granted for Elecsys NfL blood test to detect neuroinflammation in adults with relapsing‑remitting multiple sclerosis
- Elecsys NfL measures Neurofilament Light Chain (NfL) in serum/plasma on Roche cobas analyzers as a biomarker of neuroaxonal damage
- Test received FDA Breakthrough Device designation in November 2023 and aims to provide more accessible monitoring that complements MRI
CE mark and test purpose
Roche’s Elecsys NfL test received CE mark for detecting neuroinflammation in adults with relapsing‑remitting multiple sclerosis by measuring Neurofilament Light Chain (NfL), a protein released during neuroaxonal injury.
Clinical and operational implications
The assay is a minimally invasive blood test run on Roche cobas analyzers, providing standardised results that can be collected locally to reduce travel to specialist centers; results are intended to complement MRI and clinical assessment and support more frequent monitoring and earlier clinical intervention.
Biomarker and regulatory context
NfL is an abundant neuronal cytoskeletal protein and a sensitive indicator of neuroaxonal damage, with concentrations rising after axonal injury and with age and measurable in cerebrospinal fluid and blood; Elecsys NfL is an in vitro quantitative immunoassay for serum and plasma and received FDA Breakthrough Device designation in November 2023.
