Neurofilament light chain (NF-L) is a neuronal cytoskeletal protein released into biofluids upon axonal injury and neurodegeneration. Elevated plasma and cerebrospinal fluid NF-L levels have been reported across a broad range of neurological conditions, including amyotrophic lateral sclerosis, multiple sclerosis, Alzheimer's disease, and traumatic brain injury. Elevated plasma NF-L is a sensitive, quantitative indicator of ongoing neurodegeneration — rising before symptom onset, tracking disease progression, and responding to effective treatment. This translates into a powerful, non-invasive tool that can:
▸ Enrich and stratify trial populations by neurological damage burden at screening
▸ Serve as a pharmacodynamic endpoint to demonstrate target engagement
▸ Provide objective evidence of disease modification or slowing of neurodegeneration
▸ Support regulatory submissions as an exploratory, secondary, or co-primary endpoint
Established across the major neurodegenerative indications
Alzheimer's disease · MSA · ALS · Multiple sclerosis · Huntington's disease · Traumatic brain injury
NF-L has been accepted by the FDA and EMA as an exploratory biomarker in multiple IND and regulatory packages, and is increasingly featured as a secondary endpoint in Phase II/III neurology trials. By choosing a CLIA-certified, Good Clinical Laboratory Practice (GCLP)-compliant NF-L service, sponsors gain a defensible, audit-ready data package with the analytical rigor required for regulatory scrutiny.
All analytical validation described in this report — including every ELLA™ Simple Plex run, precision study, interference testing, stability testing, and carryover assessment — was performed by SBH Sciences in its CLIA-certified laboratory operating under GCLP guidelines, in collaboration with Neurodex.
This validation establishes SBH Sciences as a fully qualified provider of high-integrity NF-L biomarker data for clinical trial applications, using the ELLA™ Simple Plex immunoassay platform (Bio-Techne).
SBH Sciences provides sponsors with:
✓ CLIA-certified laboratory operations
✓ GCLP-compliant SOPs, documentation, and QA oversight
✓ Full audit trail and chain of custody
✓ Complete method validation package generated from SBH-run studies
✓ Suitable for FDA and EMA submissions
✓ EDTA plasma compatibility
✓ LIMS-based sample tracking and storage
✓ Batch reporting with QC flagging
✓ Secure electronic data transfer (SFTP / EDC integration)
The SBH Sciences validation program demonstrates that the ELLA NF-L assay meets all analytical performance criteria required for clinical biomarker deployment. All results below are derived from seven independent SBH Sciences analytical runs.
The ELLA™ Simple Plex platform (Bio-Techne) uses single-use microfluidic cartridges containing antibody-coated nanoreactors. This closed-system architecture eliminates cross-contamination, minimizes operator variability, and enables high-sensitivity chemiluminescent detection.
For NF-L, the assay spans approximately 2–2,000 pg/mL, covering both healthy baseline levels (~5–20 pg/mL) and advanced neurodegenerative disease ranges (>1,000 pg/mL).
All validation studies were executed by SBH Sciences across seven independent analytical runs in single-plate format.
Three human EDTA plasma donors with endogenous NF-L levels (~7–18 pg/mL) were used throughout. Three spike concentrations were applied:
These cover >95% of clinically relevant NF-L concentrations.
Run Structure:
SBH Sciences demonstrated exceptional linearity across the full analytical range (2–1458 pg/mL), with log-log regression yielding R² ≥ 0.9999.
Recovery remained within 80–120% across mid-to-high concentrations, with expected deviation near the LLOQ reflecting standard immunoassay behavior.
Interpretation: The assay provides reliable proportional quantification across the entire clinically relevant range for neurodegenerative disease trials.
No cross-reactivity was observed with:
All tested conditions remained below LLOQ, confirming high analytical specificity for NF-L in complex plasma matrices.
Across all SBH Sciences runs (n=21 total measurements per level):
All results met the ≤15% acceptance criterion.
Interpretation: The assay supports reliable detection of 20–30% longitudinal changes in NF-L in clinical studies.
Across three independent plasma donors:
Interpretation: Robust performance across heterogeneous clinical trial populations.
SBH Sciences evaluated hemoglobin, lipids, bilirubin, and biotin.
Conclusion: Standard GCLP pre-analytical controls are sufficient to mitigate interference risk.
NF-L demonstrated strong stability under real-world trial conditions:
Interpretation: Fully compatible with multi-site sample shipping and centralized biobanking workflows.
Carryover was minimal:
Interpretation: The ELLA cartridge system effectively eliminates carryover risk in routine use.
All blank samples were below LLOQ (~2 pg/mL), confirming:
All clinical samples were measured using SBH Sciences’ validated ELLA NF-L protocol.
Interpretation: Strong separation consistent with published ALS NF-L distributions and suitable for stratification and pharmacodynamic monitoring.
Interpretation: Robust elevation consistent with neuroaxonal injury and suitable as a longitudinal pharmacodynamic biomarker.
Across both ALS and AD datasets, SBH Sciences demonstrated:
This confirms NF-L’s utility as a broadly deployable neurodegeneration biomarker in clinical trials.
1. Sensitive enough for longitudinal change detection?
The ELLA NF-L assay is fully validated and operational within SBH Sciences as a GCLP-compliant biomarker service and CLIA-certified through our subsidiary SBH Diagnostics.
SBH Sciences provides:
Clinical trial sample testing
Biomarker strategy support
Data interpretation and regulatory documentation support
The service is immediately available for Phase I–III neurodegenerative disease trials.
Ready to add NF-L1 to your biomarker strategy? Contact SBH Sciences to learn more.
mstewart@sbhscience.com | www.sbhsciences.com