Fujirebio Secures CE Certification for Lumipulse G NfL Blood Test, Advancing Neurological Diagnostics

Gent, Belgium & Tokyo, Japan – March 17, 2026 – H.U. Group Holdings Inc., and its subsidiary Fujirebio Holdings, Inc., announced today that Fujirebio Europe N.V. Has obtained CE certification for the Lumipulse G NfL Blood assay under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This certification marks a significant step forward in the early detection and monitoring of a wide range of neurological disorders.

What is the Lumipulse G NfL Blood Assay?

The Lumipulse G NfL Blood assay is a chemiluminescent enzyme immunoassay (CLEIA) test that quantitatively measures neurofilament light chain (NfL) levels in both plasma and serum. NfL is a biomarker of neuroaxonal injury, playing a crucial role in monitoring disease progression, predicting outcomes, and evaluating treatment effectiveness across various neurological conditions. Fujirebio highlights that this is their first CE-marked blood test offering insights across a broad spectrum of neurological diseases.

Significance of CE Certification

The CE marking signifies that the Lumipulse G NfL Blood assay meets the stringent safety and performance requirements of the European Union’s IVDR. This approval allows Fujirebio Europe N.V. To market and distribute the assay within the European Economic Area. Hams Live News reports that this certification strengthens Fujirebio’s position in automated neurological diagnostics and expands its LUMIPULSE G testing platform.

Clinical Utility of NfL

According to Fujirebio, the clinical value of NfL measurements relies on careful interpretation within the appropriate clinical context. This includes utilizing age-related reference values, well-defined clinical decision rules, and longitudinal assessment of changes over time. Advances in automated immunoassays have made reliable quantification of NfL in serum and plasma possible, transitioning it from a research marker to a clinically relevant tool.

Expanding Neurological Disease Testing Solutions

“Although our assay menu already features many powerful disease-specific biomarkers, NfL marks a major breakthrough,” stated 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.” Fujirebio intends to continue collaborating with organizations and clinical experts globally to develop earlier, easier, and more complete neurological disease diagnostic tools.