Gent, Belgium – Fujirebio, a leading diagnostics company, announced today it has received CE marking for its fully automated Lumipulse® G NfL blood assay. This approval, under the European Union’s Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), marks a significant step forward in the early detection and monitoring of a wide range of neurological disorders. The test allows for the quantitative measurement of neurofilament light chain (NfL) in both plasma and serum, offering clinicians a powerful new tool for assessing neuroaxonal injury.
The announcement, made jointly by H.U. Group Holdings Inc. And its subsidiary Fujirebio Holdings, Inc., highlights the growing importance of blood-based biomarkers in neurological care. The Lumipulse G NfL assay utilizes CLEIA (chemiluminescent enzyme immunoassay) technology, providing a sensitive and reliable method for quantifying NfL levels. This is particularly crucial as researchers increasingly recognize NfL as a key indicator of neuronal damage across diverse neurological conditions.
A Breakthrough in Neurological Diagnostics
“Although 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.”
For years, diagnosing neurological conditions has relied heavily on complex and often invasive procedures like spinal taps and advanced imaging. The development of a reliable, automated blood test for NfL represents a significant shift towards more accessible and less burdensome diagnostic pathways. This is especially essential given the increasing prevalence of neurodegenerative diseases globally.
Understanding Neurofilament Light Chain (NfL)
Neurofilament light chain (NfL) is a protein released when nerve cells (neurons) are damaged. Elevated levels of NfL in blood or cerebrospinal fluid indicate neuroaxonal injury, meaning damage to the structural components of neurons. Crucially, NfL isn’t specific to one disease; it rises in response to a variety of neurological insults, making it a valuable biomarker for monitoring disease progression, predicting outcomes, and evaluating treatment effectiveness.
The clinical utility of NfL lies in its interpretation within a broader clinical context. Age-related reference values, well-defined clinical decision rules, and longitudinal assessment – tracking changes in NfL levels over time – are all essential for accurate diagnosis and management. The availability of a standardized, automated assay like the Lumipulse G NfL test is expected to improve the consistency and reliability of NfL measurements across different laboratories and clinical settings.
From Research Marker to Clinical Tool
Historically, NfL measurement was primarily confined to research settings due to the limitations of available assays. Advances in sensitive and fully automated immunoassays, like the one developed by Fujirebio, have enabled reliable quantification of NfL in serum and plasma, facilitating its transition into routine clinical practice. This shift is particularly significant for conditions like multiple sclerosis, Alzheimer’s disease, frontotemporal dementia, and amyotrophic lateral sclerosis (ALS), where early diagnosis and intervention are critical.
In neurodegenerative diseases, elevated NfL levels consistently reflect axonal damage, regardless of the underlying cause – whether inflammatory, vascular, infectious, or traumatic. This broad applicability makes NfL a valuable tool for differentiating between various neurological conditions and monitoring disease activity.
Fujirebio’s Commitment to Innovation
Fujirebio has a long-standing history of innovation in the diagnostics industry, with over 75 years of experience providing solutions to healthcare providers, pharmaceutical laboratories, and in vitro diagnostic (IVD) partners worldwide. The company’s expertise spans neurology, oncology, infectious diseases, and other key areas. The LUMIPULSE® G platform, on which the NfL assay is run, is known for its robustness and automation capabilities.
As a member of H.U. Group, Fujirebio leverages strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. The company’s flexible CDMO (Contract Development and Manufacturing Organization) model allows it to accelerate the development and commercialization of innovative diagnostic tests through strategic partnerships within the life sciences sector.
The CE marking for the Lumipulse G NfL assay represents a major milestone for Fujirebio and a significant advancement for the field of neurological diagnostics. By providing clinicians with a reliable and accessible tool for measuring NfL, Fujirebio is contributing to earlier, more accurate diagnoses and improved patient care.
For more information, visit www.fujirebio.com.
Next Steps: Fujirebio plans to continue expanding its portfolio of neurological diagnostic solutions and collaborating with clinical experts to further refine the application of NfL in clinical practice. The company will as well focus on making the Lumipulse G NfL assay available to a wider range of healthcare providers globally.
