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Translating neurofilament light chain testing into clinical practice: a multidisciplinary implementation roadmap.

Roberto Furlan1,2, Alessia Di Sapio3, Diana Ferraro4

  • 1Vita-Salute San Raffaele University, Milan, Italy.

Clinical Chemistry and Laboratory Medicine
|March 14, 2026
PubMed
Summary

Neurofilament light chain (NfL) is a sensitive biomarker for neuroaxonal injury. This paper outlines a roadmap for its clinical use, standardizing testing and interpretation for precision neurology.

Keywords:
biomarker standardizationclinical validationmultiple sclerosisneurodegenerationreal-world evidence

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Area of Science:

  • Biomarker Discovery and Validation
  • Neuroscience
  • Clinical Chemistry

Background:

  • Neurofilament light chain (NfL) is a validated biomarker for neuroaxonal injury in various neurological conditions.
  • Existing evidence supports NfL's role in diagnosis, prognosis, and monitoring of neurodegenerative diseases.

Purpose of the Study:

  • To provide a multidisciplinary roadmap for the clinical translation of circulating NfL testing.
  • To integrate analytical, interpretative, and organizational aspects for routine NfL implementation.

Main Methods:

  • Review of biological basis and clinical evidence for NfL.
  • Comparative analysis of immunoassay technologies and identification of variability sources.
  • Development of operational guidelines for standardization and quality control.

Main Results:

  • NfL shows high sensitivity to neuroaxonal injury in both acute and chronic neurological conditions.
  • Age, BMI, renal function, and comorbidities significantly impact NfL interpretation, necessitating adjusted scores.
  • Practical indications for NfL testing in multiple sclerosis (MS) are proposed for disease monitoring and treatment decisions.

Conclusions:

  • Harmonized analytical procedures, interdisciplinary education, and governance are crucial for NfL's clinical transition.
  • Regulatory qualification, reference materials, and real-world trials are priority actions for consolidating NfL utility.
  • NfL is poised to become a cornerstone biomarker for precision neurology and neurodegeneration monitoring.