Automated NfL Assay Supports Monitoring of Neurological Disorders

Blood-based measurement of neurofilament light chain (NfL) provides a biologically meaningful indicator when interpreted using age-adjusted reference values and longitudinal trends. A new fully automated blood assay has now received CE certification, enabling standardized, quantitative measurement of NfL in plasma and serum for use in clinical laboratories.

Fujirebio Europe N.V. (Ghent, Belgium) has obtained a CE Certificate for the Lumipulse G NfL Blood assay under Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The assay is designed for use on the Lumipulse G system and provides a quantitative result intended to support neurological evaluation. The certification extends the company’s neuro-focused test menu on its automated platform.

The Lumipulse G NfL Blood assay uses chemiluminescent enzyme immunoassay (CLEIA) methodology to detect and quantify NfL in human plasma and serum. By automating the workflow, the assay enables standardized processing and readout suitable for high-throughput laboratory environments. The CLEIA format supports sensitive detection aligned with routine clinical operations.

NfL is a marker of neuroaxonal injury that can support disease monitoring, prognosis, and treatment evaluation across a wide range of neurological conditions, including multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), and traumatic brain injury (TBI). Its clinical utility depends on context-specific interpretation, including age-adjusted reference ranges, defined clinical decision thresholds, and longitudinal tracking. Elevated NfL levels reflect axonal damage across neurodegenerative disorders of inflammatory, vascular, infectious, and traumatic origin, largely independent of the underlying disease mechanism.

“While our assay menu already features many powerful disease-specific biomarkers, NfL marks a major breakthrough: our first CE-marked blood test that empowers clinicians with insights across a wide range of neurological disorders,” said Christiaan De Wilde, CEO at Fujirebio Europe N.V.

“We are excited to bring this test to our customers, further expanding our comprehensive portfolio of fully automated neurological disease testing solutions on the LUMIPULSE G platform. We continue to partner with organizations and clinical experts across the world to enable earlier, easier and more complete neurological disease diagnostic tools,” said De Wilde.

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