Fujirebio Announces CE Marking of the Fully Automated Lumipulse® G Nfl Blood Assay

GENT, Belgium & TOKYO--(BUSINESS WIRE)--H.U. Group Holdings Inc., and its wholly owned subsidiary, Fujirebio Holdings, Inc. (hereinafter “Fujirebio”) today announced that Fujirebio Europe N.V. has obtained a CE Certificate of the Lumipulse G NfL Blood assay under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This CLEIA (chemiluminescent enzyme immunoassay) test 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,” 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.”

About NfL

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 quantification of NfL 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.

About Fujirebio

Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and in vitro diagnostics (IVD) partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust LUMIPULSE^® G platform, Fujirebio’s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry.

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.

More information can be found at www.fujirebio.com.