GENT, BELGIUM & TOKYO -- H.U. Group Holdings Inc., and its wholly owned subsidiary, Fujirebio Holdings, Inc. (hereinafter “Fujirebio”) 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.”