GENT, Belgium and TOKYO – Fujirebio Europe N.V. Has secured CE marking for its Lumipulse G NfL Blood assay, a significant step forward in the diagnosis and monitoring of neurological disorders. The announcement, made by H.U. Group Holdings Inc. And its subsidiary Fujirebio Holdings, Inc., signifies the assay’s compliance with the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). This automated test offers a fresh tool for clinicians seeking earlier and more comprehensive insights into a range of neurological conditions.
The Lumipulse G NfL Blood assay utilizes CLEIA (chemiluminescent enzyme immunoassay) technology to quantitatively measure Neurofilament light chain (NfL) levels in both plasma, and serum. NfL is increasingly recognized as a crucial biomarker for neuroaxonal injury, playing a vital role in disease monitoring, prognosis, and evaluating treatment effectiveness across various neurological illnesses. The availability of a standardized, automated test like this represents a shift from NfL being primarily a research marker to a clinically relevant diagnostic aid.
A New Era in Neurological Diagnostics
“Our assay portfolio already includes numerous powerful disease-specific biomarkers, but NfL represents a significant breakthrough: our first CE-marked blood test that provides physicians with insights across a broad spectrum of neurological diseases,” explained Christiaan De Wilde, CEO of Fujirebio Europe N.V. “We are excited to offer this test to our customers and further expand our extended portfolio of fully automated testing solutions for neurological disorders on the LUMIPULSE G platform. We continue to collaborate with companies and clinical experts worldwide to deliver earlier, more user-friendly, and comprehensive diagnostics for neurological diseases.”
The development of this CE-marked assay is particularly significant given the growing understanding of NfL’s role in a diverse array of neurological conditions. Elevated NfL levels consistently reflect axonal damage in neurodegenerative diseases – including Alzheimer’s, Parkinson’s, and multiple sclerosis – as well as inflammatory, vascular, infectious, and traumatic brain injuries. Importantly, this axonal damage appears largely independent of the underlying disease mechanisms, making NfL a potentially valuable indicator across a wide patient population.
Understanding Neurofilament Light Chain (NfL)
Neurofilament light chain (NfL) is released into the bloodstream when nerve cells are damaged. Measuring NfL levels can support doctors track the progression of neurological diseases, assess the effectiveness of treatments, and potentially predict future outcomes. But, interpreting NfL levels requires careful consideration of several factors. Age-based reference values, clearly defined clinical decision rules, and longitudinal tracking of changes over time are all essential for accurate assessment. Simply put, a single NfL reading isn’t enough; clinicians need to see trends and consider the patient’s overall clinical picture.
The advancement of sensitive and fully automated immunoassays has been key to enabling reliable quantification of NfL in serum and plasma. This has facilitated the transition of NfL from a research-focused marker to a tool with real-world clinical applications. The Lumipulse G platform, with its automation capabilities, aims to streamline this process, making it more accessible for routine clinical leverage.
Fujirebio’s Expanding Neuro Diagnostics Portfolio
Fujirebio has been steadily expanding its offerings in the field of neurological diagnostics. In 2023, the company introduced assays for Neurofilament Light (NfL) and pTau 217 for research use only. The addition of the CE-marked NfL blood test further solidifies Fujirebio’s commitment to providing comprehensive solutions for neurological disease management. The company’s open business model, leveraging strategic partnerships within the broader life sciences industry, is designed to accelerate access to these innovative diagnostics.
As part of the H.U. Group, Fujirebio combines strong research and development capabilities, regulatory expertise, and scalable manufacturing to deliver high-performance diagnostic solutions. The company too offers a flexible CDMO (Contract Development and Manufacturing Organization) model, assisting diagnostic partners in bringing validated solutions to market more quickly. This collaborative approach aims to improve patient outcomes through better decision-making, treatments, and overall care.
What’s Next for Fujirebio and Neurological Diagnostics?
Fujirebio’s focus remains on expanding its neuro biomarker menu and strengthening its LUMIPULSE G testing platform. The company is actively collaborating with global partners and clinical experts to further refine diagnostic tools and improve the understanding of neurological diseases. The CE marking of the NfL assay is a crucial milestone, but it’s likely just the beginning of a wave of innovation in this rapidly evolving field.
The availability of this test in Europe, following its release in Japan and the United States, marks a significant step towards standardized neurological assessments globally. Clinicians now have access to a more precise and efficient method for evaluating patients at risk of or affected by a wide range of neurological conditions. The Lumipulse G NfL Blood assay promises to play an increasingly important role in the early detection, monitoring, and management of these complex diseases.
For more information, visit www.fujirebio.com.
Next Steps: Fujirebio will continue to roll out the Lumipulse G NfL Blood assay across additional regions throughout 2026. Keep an eye on Archysport for further updates on advancements in neurological diagnostics and their impact on patient care.
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