{"id":62798,"date":"2026-03-17T07:06:49","date_gmt":"2026-03-17T06:06:49","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fujirebio-announces-ce-marking-of-the-fully-automated-lumipulse-g-nfl-blood-assay\/"},"modified":"2026-03-17T07:06:49","modified_gmt":"2026-03-17T06:06:49","slug":"fujirebio-announces-ce-marking-of-the-fully-automated-lumipulse-g-nfl-blood-assay","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fujirebio-announces-ce-marking-of-the-fully-automated-lumipulse-g-nfl-blood-assay\/","title":{"rendered":"Fujirebio Announces CE Marking of the Fully Automated Lumipulse\u00ae G Nfl Blood Assay"},"content":{"rendered":"
\n

GENT, Belgium & TOKYO–(BUSINESS WIRE)–#IVD<\/a>–H.U. Group Holdings Inc., and its wholly owned subsidiary, Fujirebio Holdings, Inc. (hereinafter \u201cFujirebio\u201d) 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 <\/i>diagnostic medical devices (IVDR). This CLEIA (chemiluminescent enzyme immunoassay) test allows for the quantitative measurement of Neurofilament light chain (NfL) in plasma and serum.<\/p>\n

<\/a>
<\/a><\/p>\n

\n\u201cWhile 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,\u201d<\/i> said Christiaan De Wilde, CEO at Fujirebio Europe N.V. \u201cWe 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.\u201d<\/i><\/p>\n

\nAbout NfL<\/b><\/p>\n

\nNeurofilament 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.<\/p>\n

\nAdvances 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 \u2013 elevated NfL levels consistently reflect axonal damage largely independent of underlying pathogenic mechanisms.<\/p>\n

\nAbout Fujirebio<\/b><\/p>\n

\nFujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and in vitro<\/i> diagnostics (IVD) partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust LUMIPULSE\u00ae<\/sup> G platform, Fujirebio\u2019s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry.<\/p>\n

\nPart of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio\u2019s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster\u2014driving better decisions, treatments, and patient outcomes.<\/p>\n

\nMore information can be found at www.fujirebio.com<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nFor media:
\n
Public Relations Section, Public Relations\/Sustainability Department,
\n
H.U. Group Holdings, Inc.
\n
Phone: +81-3-6279-0884
\n
E-mail: pr@hugp.com<\/a><\/p>\n

\nChristiaan De Wilde
\n
CEO Fujirebio Europe
\n
Phone: +32 9329 1703<\/p>\n

\nFor investors and analysts:
\n
IR\/SR Dept.
\n
Phone: +81-3-5909-3337
\n
E-mail: ir@hugp.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

GENT, Belgium & TOKYO–(BUSINESS WIRE)–#IVD–H.U. Group Holdings Inc., and its wholly owned subsidiary, Fujirebio Holdings, Inc. (hereinafter \u201cFujirebio\u201d) 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 … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62798","6":"format-standard","7":"category-industry"},"yoast_head":"\nFujirebio Announces CE Marking of the Fully Automated Lumipulse\u00ae G Nfl Blood Assay - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/fujirebio-announces-ce-marking-of-the-fully-automated-lumipulse-g-nfl-blood-assay\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fujirebio Announces CE Marking of the Fully Automated Lumipulse\u00ae G Nfl Blood Assay - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"GENT, Belgium & TOKYO–(BUSINESS WIRE)–#IVD–H.U. Group Holdings Inc., and its wholly owned subsidiary, Fujirebio Holdings, Inc. (hereinafter \u201cFujirebio\u201d) 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 ... 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