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GENT, Belgium & TOKYO — 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.
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“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,”
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said Christiaan De Wilde, CEO at Fujirebio Europe N.V.
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“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.”
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About NfL
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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.
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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.
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About Fujirebio
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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.
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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.
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More information can be found at www.fujirebio.com.
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Contacts
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For media:
Public Relations Section, Public Relations/Sustainability Department,
H.U. Group Holdings, Inc.
Phone: +81-3-6279-0884
E-mail: [email protected] Christiaan De Wilde
CEO Fujirebio Europe
Phone: +32 9329 1703
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For investors and analysts:
IR/SR Dept.
Phone: +81-3-5909-3337
E-mail: [email protected]
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English (US)