Fujirebio Announces CE Marking of the Fully Automated Lumipulse® G Nfl Blood Assay
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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.Sign In or Create an AccountEmail AddressContinueor View more offersArticle contentArticle content“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,”Article contentWe apologize, but this video has failed to load.Try refreshing your browser, ortap here to see other videos from our team.Article contentTop StoriesGet the latest headlines, breaking news and columns.There was an error, please provide a valid email address.Sign UpBy signing up you consent to receive the above newsletter from Postmedia Network Inc.Thanks for signing up!A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againInterested in more newsletters? Browse here.Article contentsaid Christiaan De Wilde, CEO at Fujirebio Europe N.V.Article content“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.”Article contentAbout NfLArticle contentNeurofilament 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.Article contentAdvances 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.Article contentAbout FujirebioArticle contentFujirebio 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.Article contentPart 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.Article contentMore information can be found at www.fujirebio.com.Article contentArticle contentArticle contentArticle contentView source version on businesswire.com: Article content https://www.businesswire.com/news/home/20260316411567/en/Article contentArticle contentContactsArticle contentFor media: Public Relations Section, Public Relations/Sustainability Department, H.U. Group Holdings, Inc. Phone: +81-3-6279-0884 E-mail: pr@hugp.com Christiaan De Wilde CEO Fujirebio Europe Phone: +32 9329 1703Article contentFor investors and analysts: IR/SR Dept. Phone: +81-3-5909-3337 E-mail: ir@hugp.com#distroArticle contentTrending Subscriber only.
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The United States is losing its grip on Canada's steel market Subscriber only Commodities Posthaste: Even Americans are getting fed up with Donald Trump's tariffs News Bank of Canada expected to hold interest rates as nation faces trade uncertainty, global conflict Economy Saint John's port is booming as Ontario shippers seek to dodge U.S. tariffs Economy Xanadu teams up with Telus to build Canadian quantum computing infrastructure Innovation