New IVDR-approved assay enables earlier detection and monitoring of neurological disorders
H.U. Group Holdings Inc., through its wholly owned subsidiary Fujirebio Holdings, Inc., has announced that Fujirebio Europe N.V. has secured CE certification for its Lumipulse G NfL Blood assay under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The newly approved test is based on CLEIA (chemiluminescent enzyme immunoassay) technology and enables quantitative measurement of Neurofilament light chain (NfL) in plasma and serum. This development strengthens Fujirebio’s position in automated neurological diagnostics and expands its LUMIPULSE G testing platform.
Christiaan De Wilde, CEO of Fujirebio Europe, described the assay as a significant milestone. He noted that while the company already offers several disease-specific biomarkers, this marks its first CE-marked blood test capable of providing insights across a broad spectrum of neurological conditions. The company aims to support clinicians with earlier and more comprehensive diagnostic tools through continued collaboration with global partners and clinical experts.
Understanding the role of NfL in neurological diseases
Neurofilament light chain (NfL) is a clinically relevant biomarker that reflects neuroaxonal injury. It plays an important role in disease monitoring, prognosis, and treatment evaluation across multiple neurological disorders.
The interpretation of NfL levels requires careful clinical context, including age-based reference values, defined decision frameworks, and longitudinal tracking over time. With advancements in sensitive and automated immunoassays, reliable measurement of NfL in blood samples has now become possible, helping transition it from a research marker to a practical clinical tool.
Elevated NfL levels are consistently associated with axonal damage across a wide range of neurological conditions, including neurodegenerative, inflammatory, vascular, infectious, and traumatic disorders. Importantly, this elevation occurs largely independent of the underlying disease mechanism, making it a versatile biomarker.
Fujirebio’s legacy in diagnostic innovation
Fujirebio brings over 75 years of experience in developing advanced diagnostic solutions for healthcare providers, pharmaceutical companies, and in vitro diagnostics partners worldwide. Its expertise spans neurology, oncology, infectious diseases, and related fields.
Operating under H.U. Group, the company combines strong research and development capabilities with regulatory expertise and scalable manufacturing. Its LUMIPULSE G platform offers a robust, fully automated solution for disease testing, while its flexible CDMO model enables partners to accelerate the delivery of validated diagnostic products to market.
By expanding its neurological testing portfolio with the NfL assay, Fujirebio continues to focus on improving diagnostic accuracy, enabling better clinical decisions, and ultimately enhancing patient outcomes.
