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Neurofilament Light Chain (NfL)  A simple blood test delivering key insights into MS disease activity

Introducing NfL, the groundbreaking blood test first to be CE marked* for predicting the risk of future MS disease activity. The NfL assay is offered on the Atellica IM, Atellica CI, and ADVIA Centaur XP/XPT systems and provides fast, reproducible, novel insights into MS (Multiple Sclerosis) disease activity; from a simple blood draw using serum and plasma.†

Neuron illustration with NfL highlighted

Benefits

Unlock insights into relapsing multiple sclerosis (RMS) with a simple blood test

Chart showing repeatability and reproducibility of the NfL assay

Figure 1: Repeatability and reproducibility of the Atellica IM NfL assay.1

This highly sensitive assay offers innovative, reproducible results to improve MS patient management. 

  • The first blood-based CE marked NfL assay for predicting MS disease activity.1

  • Delivers the sensitivity needed with a limit of quantitation of 3.0 pg/mL.1

  • Reproducible results supporting RMS patient management.2,3,4

Chart with aseline levels of NfL associated with a ~75 percent higher rate of new or enlarging lesions/year
Figure 2. Baseline levels of NfL associated with a ~75 percent higher rate of new or enlarging lesions/year (Siemens Healthineers NfL decision cut point of ≥12.9 pg/mL)1

Setting a new standard with the first approved prognostic risk assessment for RMS.

  • A simple decision threshold of 12.9 pg/mL.1

  • Provides confidence in decision making.2,3,4

  • Recommended in clinical guidance.2

Atellica AIA IPQ being flushed to move a STAT sample in the front of the line
Run on Atellica analyzers, these types of tests are scalable and therefore available to more physicians and patients.

Seamlessly consolidate NfL into your clinical laboratory workflow.

  • Available for both serum and EDTA plasma for easy integration.

  • A fully automated routine immunoassay.

  • No additional pre-analytical steps.

Chart showing repeatability and reproducibility of the NfL assay

Figure 1: Repeatability and reproducibility of the Atellica IM NfL assay.1

This highly sensitive assay offers innovative, reproducible results to improve MS patient management. 

  • The first blood-based CE marked NfL assay for predicting MS disease activity.1

  • Delivers the sensitivity needed with a limit of quantitation of 3.0 pg/mL.1

  • Reproducible results supporting RMS patient management.2,3,4

Technical Details

Assay Specifications  

System Availability

Assay Specifications

Sample Type 

Serum and EDTA Plasma

Analytical Measuring Range

3.0 – 300.0 pg/mL

Sample Volume

100 µL

System Availability

Atellica IM Analyzer

Deliver innovative results with high reproducibility, workflow efficiency, and reduced operator intervention.

Atellica CI Analyzer

Unrivaled versatility using the same technology, assays, workflow and user interface as the Atellica Solution.

ADVIA Centaur XP/XPT Systems

Integrate NfL results onto a comprehensive immunoassay platform.

Evidence

“NfL addresses a major unmet need in management of MS for blood biomarkers...”
Guidance for use of neurofilament light chain as a cerebrospinal fluid and blood biomarker in multiple sclerosis management
Freedman, Mark S. et al.eBioMedicine, Volume 101, 104970

All trademarks are the property of their respective owners.

NfL is not available for sale in the United States and may not be commercially available in all countries. Future availability cannot be guaranteed and is dependent on local regulatory requirements.

*
CE 0197
†

The Atellica IM NfL assay, in conjunction with clinical, imaging, and laboratory findings, is intended to be used as an aid in identifying adult patients between 18–55 years of age with Relapsing Multiple Sclerosis (RMS), who are at a higher versus lower risk of MS disease activity, as defined by new or enlarging T2 (neT2) magnetic resonance imaging (MRI) lesions, within a 2 year period.

1

Atellica IM NfL Assay IFU. Siemens Healthcare Diagnostics Inc. 11209406_EN Rev. 01, 2024-04.

2

Freedman MS, et al. Guidance for use of neurofilament light chain as a cerebrospinal fluid and blood biomarker in multiple sclerosis management. eBioMedicine. 2024 Mar;101:104970. Available from: https://doi.org/10.1016/j.ebiom.2024.104970

3

Calabresi PA, et al. Temporal profile of serum neurofilament light in multiple sclerosis: Implications for patient monitoring. Mult Scler. 2021;27(10):1497-1505.

4

Kosa P, et al. Enhancing the clinical value of serum neurofilament light chain measurement. JCI Insight. 2022;7(15):e161415.

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