CE Mark Granted to Fujirebio’s Fully Automated Lumipulse G Nfl Blood Assay

Fujirebio Europe N.V. has obtained a CE Mark certification for the Lumipulse G NfL Blood assay, a CLEIA (chemiluminescent enzyme immunoassay) test that allows for the quantitative measurement of Neurofilament light chain (NfL) in plasma and serum.

“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,” Fujirebio Europe N.V. CEO Christiaan De Wilde said. “We are excited to bring this test to our customers, further expanding our 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.”

Neurofilament light chain (NfL) is a biologically relevant biomarker of neuroaxonal injury that can support disease monitoring, prognosis, and treatment evaluation across a wide range of neurological disorders. Its clinical utility depends on interpretation within the appropriate clinical context, using age-related ref values, well-defined clinical decision rules, and longitudinal assessment of change over time.

Advances in sensitive and fully automated immunoassays have enabled reliable NfL quantification in serum and plasma, supporting its transition from a research marker to a clinically relevant tool. Across neurodegenerative diseases of different etiologies—inflammatory, vascular, infectious, and traumatic conditions—elevated NfL levels consistently reflect axonal damage largely independent of underlying pathogenic mechanisms.

H.U. Group Holdings Inc. and its wholly owned subsidiary, Fujirebio Holdings Inc., are diagnostics companies with more than 75 years of experience delivering solutions to healthcare providers, pharmaceutical companies, and in-vitro diagnostics (IVD) partners worldwide. Leveraging expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the LUMIPULSE G platform, Fujirebio’s open business model accelerates access to diagnostics through strategic life sciences partnerships. Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio’s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster—driving better decisions, treatments, and patient outcomes.