Fujirebio Expands Access in Canada to Blood-based Neurology Testing with Health Canada Class II Medical Device Licenses for the Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma Assays

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Postmedia has not reviewed the content. by Business Wire Fujirebio Expands Access in Canada to Blood-based Neurology Testing with Health Canada Class II Medical Device Licenses for the Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma AssaysAuthor of the article:GHENT, Belgium & TOKYO — H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Health Canada has issued Class II Medical Device Licenses (MDL) for the Lumipulse G NfL Blood and the Lumipulse G pTau 217 Plasma assay for use on the fully automated LUMIPULSE® G immunoassay platform in the Canadian market.THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an Account“The approval of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for clinical use in Canada marks another important step in our mission to expand access to reliable and clinically meaningful blood-based biomarkers for clinicians and patients worldwide,”said Christiaan De Wilde, CEO of Fujirebio Europe N.V.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.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 again“As a pioneer in neurological diagnostics, Fujirebio remains committed to advancing patient care through innovative, fully automated testing solutions.”These approvals further strengthen Fujirebio’s comprehensive neurological diagnostics portfolio by broadening access to high-quality biomarker solutions designed to inform clinical decision-making across the patient journey. Through its continuously expanding menu of blood-based and cerebrospinal fluid (CSF) biomarkers, Fujirebio aims to contribute to earlier detection, more informed treatment decisions, and improved patient care in neurological disease. The Class II Medical Device Licenses (MDL) issued by Health Canada are based on the already CE marked IVD versions of these two assays.About Lumipulse G NfL BloodThe Lumipulse G NfL Blood assay provides a reliable method for the quantitative measurement of neurofilament light chain (NfL) in serum and plasma.NfL is a well-established biomarker of neuro-axonal injury and has been studied across a wide range of neurological conditions, including for its potential utility in disease monitoring, prognosis, and assessment of treatment response. This broad applicability underscores the value of linking the biomarker to pathophysiology it represents rather than to a disease, consistent with the CE marked version of the assay.The interpretation of Lumipulse G NfL Blood results should always be guided by the clinical context and supported by age-adjusted reference values and validated clinical decision frameworks.About Lumipulse G pTau 217 PlasmaTau phosphorylated at threonine 217 (pTau 217) is currently considered the most specific blood-based biomarker for Alzheimer’s disease (AD), facilitating the assessment of underlying AD pathology and helping clinicians distinguish AD from other causes of neurodegeneration.The Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers in identifying patients with amyloid pathology associated with AD in individuals aged 50 years and older presenting with signs and symptoms of cognitive decline in specialized care settings. The Lumipulse G pTau 217 Plasma assay is to be used as an adjunct to other diagnostic evaluations.The approval of the Lumipulse G pTau 217 Plasma assay by Health Canada is consistent with the recent CE marking of the product in Europe.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.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.For more information, please visit www.fujirebio.com Lumipulse is a registered trademark of Fujirebio Inc.View source version on businesswire.com: For 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 1703This advertisement has not loaded yet.Notice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.