Elecsys® NfL

IVD For in vitro diagnostic use.

A supportive healthcare provider discusses a personalized MS treatment plan during a patient consultation.

The need for proactive monitoring

Multiple sclerosis (MS) is a progressive disease affecting approximately 2.8 million people worldwide.1 Early and regular monitoring of disease activity is critical to optimizing treatment, yet some patients can find it difficult to access routine assessments, such as MRI scanning, that would allow timely detection of changes in their condition. 

In MS, localized inflammation leads to the disruption of the myelin sheet and axonal cytoskeleton, which can cause the release of neurofilament light chain (NfL) into the brain fluid and blood.2,3 Standard clinical assessments and MRI sequences are valuable, but they often fail to capture the full extent of continuous MS pathology, particularly the subclinical disease activity that occurs before irreversible damage is visible on a scan.4

Unmet need

MS care is hampered by limited tools for closer monitoring of disease activity. Around 85% of patients experience a relapsing form of MS that can appear stable while underlying progression continues.5

The current standard of care includes either assessment tools that have high clinical utility but are costly and time-consuming, leading to accessibility issues, or tools that lack the standardization to detect subtle disease changes, limiting accurate identification of long-term disease progression.6,7

There is a pressing need for a personalized approach, with accessible and scalable solutions to catch early signs of disease activity and monitor treatment response.8,9

Elecsys® NfL: Bridging the gap in MS management

Neurofilament light chain (NfL) is an abundant cytoskeletal protein found almost exclusively in neurons.10,11 In brain fluid and blood, NfL is a sensitive indicator of neuroaxonal damage.12,13 Under normal conditions, NfL is released at low levels from axons; however, turnover increases with age and following neuroaxonal damage.10 Consequently, abnormally elevated NfL concentrations can be measured in brain fluid and blood in a range of acute and chronic neurological disorders.12,13

Roche’s Elecsys® NfL is an in vitro quantitative immunoassay for the measurement of NfL protein in human serum and plasma. Elecsys® NfL is intended to be used to reflect neuroinflammation in adult subjects diagnosed with relapsing-remitting multiple sclerosis.14

By providing an objective, highly sensitive measure of recent neuroaxonal injury, this rapid 18-minute assay helps make subsurface disease activity visible, empowering healthcare professionals with deeper insights between routine MRI assessments.14

We are deeply committed to innovate across the care path with the focus on making the detection of disease activity more convenient, and standardized to improve the outcome for people living with multiple sclerosis.

A researcher shines a light on a human head silhouette, revealing a neuron with damaged myelin, illustrating MS.
Benefits at a glance

Benefits at a glance

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Overview

Ordering information

Product specification

Value

Sample type

Serum and Plasma

Testing principle

2-steps sandwich assay

Sample volume

48 µl

Measuring range

0.3–500 pg/mL

Turnaround time

18 min

Supported instruments

cobas® e 402 & e 801

Reagent onboard stability

16 weeks

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References
  1. Walton C, King R, Rechtman L, et al. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec; 26(14):1816-1821.
  2. Friese MA, et al. Mechanisms of neurodegeneration and axonal dysfunction in multiple sclerosis. Nat Rev Neurol. 2014;10(4):225-38.
  3. Preziosa P, et al. Current state-of-art of the application of serum neurofilaments in multiple sclerosis diagnosis and monitoring. Expert Rev Neurother. 2020;20(8):747-769.
  4. Thebault S, et al. Serum Neurofilament Light Chain Measurement in MS: Hurdles to Clinical Translation. Front Neurol. 2021;15:654942.
  5. National Multiple Sclerosis Society. Relapsing-Remitting Multiple Sclerosis (RRMS) [Internet; cited 2026 Mar 30]. Available from: https://www.nationalmssociety.org/understanding-ms/what-is-ms/types-of-ms/relapse-remitting-ms.
  6. Zettl UK, et al. Challenges in monitoring the quality of care in multiple sclerosis. Lancet Reg Health Eur. 2024 May 25;42:100950.
  7. Thebault S, et al. Serum neurofilament light chain measurement in multiple sclerosis: Hurdles to clinical translation. Front Neurol. 2020;11:585834.
  8. Kappos L, et al. Contribution of relapse-independent progression vs relapse-associated worsening to overall confirmed disability accumulation in typical relapsing multiple sclerosis in a pooled analysis of 2 randomized clinical trials. JAMA Neurol. 2020;77:1132-40.
  9. Giovannoni G. Why do you have to be lucky to get the MS treatment you deserve? Mult Scler Relat Disord. 2016;8:A3-4.
  10. Gaetani L, et al. Neurofilament light chain as a biomarker in neurological disorders. J Neurol Neurosurg Psychiatry. 2019;90:870–881.
  11. Gafson AR, et al. Neurofilaments: neurobiological foundations for biomarker applications. Brain. 2020;143:1975–98.
  12. Khalil M, et al. Neurofilaments as biomarkers in neurological disorders. Nat Rev Neurol 2018;14:577–589.
  13. Freedman MS, et al. Guidance for use of neurofilament light chain as a cerebrospinal fluid and blood biomarker in multiple sclerosis management. EBioMedicine. 2024;101:104970.
  14. F. Hoffmann-La Roche Ltd. Elecsys® NfL Method Sheet. (v1.0). 2025. 
  15. Itorralba J and Schneider R. The Prognostic Utility of Neurofilament Light Chain in Multiple Sclerosis: A Narrative Review. Pract Neurol. 2024;23(2):18-21.
  16. Booth RA, et al. Validation and generation of age-specific reference intervals for a new blood neurofilament light chain assay. Clin Chim Acta. 2025;577:120447.
  17. Novakova L, et al. Monitoring disease activity in multiple sclerosis using serum neurofilament light protein. Neurology. 2017;89:2230-7.
  18. Varhaug KN, et al. Neurofilament light chain predicts disease activity in relapsing-remitting MS. Neurol Neuroimmunol Neuroinflamm. 2018;5:e422.
  19. Bittner S et al, Brain. The potential of serum neurofilament as biomarker for multiple sclerosis. 2021;144:2954-63.