Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma

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GHENT, Belgium & TOKYO — H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted market authorization for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE^® G immunoassay platform in Brazil.

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“ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway.”

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The Brazilian ANVISA authorizations are based on the already CE marked in vitro diagnostics (IVD) approvals of these two assays, reflecting conformity with the safety and performance requirements of the different regulatory agencies. The assays were also granted Class II Medical Device Licenses (MDL) by Health Canada earlier this month. Together, these milestones broaden access to Fujirebio’s high-quality biomarker solutions and strengthen its comprehensive neurological diagnostics portfolio. Through its expanding menu of blood-based and cerebrospinal fluid (CSF) biomarkers, Fujirebio aims to contribute to a timelier diagnosis, more informed treatment decisions and improved patient care in neurological disease.

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About Lumipulse G NfL Blood

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The Lumipulse G NfL Blood assay is intended for the quantitative measurement of neurofilament light chain (NfL) in human serum and plasma.

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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 the pathophysiology it represents rather than to a disease.

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Results from the Lumipulse G NfL Blood assay should be interpreted in the clinical context and with appropriate reference values and validated clinical decision frameworks.

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About Lumipulse G pTau 217 Plasma

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Tau phosphorylated at threonine 217 (pTau 217) is a highly specific blood-based biomarker associated with Alzheimer’s disease (AD) pathology. It can support the assessment of underlying amyloid pathology and help clinicians distinguish AD from other causes of cognitive decline.

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The Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers in identifying amyloid pathology associated with AD in individuals aged 50 years and older who present themselves with signs and symptoms of cognitive decline in specialized care settings. The assay is to be used as an adjunct to other diagnostic evaluations.

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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 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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For more information, please visit www.fujirebio.com Lumipulse is a registered trademark of Fujirebio Inc.

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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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