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Fujirebio submits FDA regulatory filing for Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic test as an aid to identify patients with Amyloid pathology associated with Alzheimer's disease

— Expected to Be First Commercially-Available Blood-Based In-Vitro Diagnostic for Patients Being Assessed for Alzheimer’s Disease in the U.S.
— Availability of Accurate, Assessable, Blood-Based Diagnostic Tests Will Aid in Development and Availability of More Effective Interventions for Alzheimer’s Disease

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Biogen, Beckman Coulter and Fujirebio to collaborate on blood-based biomarkers and test for tau pathology in Alzheimer’s disease

Cambridge, Mass. and Brea, Calif. and Tokyo, Japan – JULY 30, 2024 – Biogen Inc. (Nasdaq: BIIB), Beckman Coulter, Inc. and Fujirebio announced a collaboration to potentially identify and develop blood-based biomarkers for tau pathology in the brain and to potentially clinically advance and potentially commercialize new tests for tau pathology in Alzheimer’s disease (AD). The development of tau-specific blood-based biomarkers that can measure a patient’s tau burden could provide critical insights into the underlying pathological processes of AD and may help advance the development of a new generation of therapies impacting tau pathology.

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Fujirebio launches the fully automated Lumipulse® G GFAP assay for Research Use Only and further strengthens its Neuro test menu

Tokyo, Japan, Malvern PA, USA, and Gent, Belgium, July 26, 2024 – H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G GFAP assay for the fully automated, random-access LUMIPULSE® G immunoassay systems. The Research Use Only (RUO) assay is now available in Japan and the United States, and it will be available in Europe and other regions* as of September this year. The Chemiluminescent Enzyme Immunoassay (CLEIA) test allows for the quantitative measurement of glial fibrillary acidic protein (GFAP) in human plasma and serum in just 35 minutes.

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AriBio Co., Ltd. and Fujirebio Diagnostics, Inc. announce milestone achievement to advance biomarker development for Alzheimer’s disease and Neurodegeneration

San Diego, CA, Tokyo, Japan and Malvern, PA -- (BUSINESS WIRE), July 12th, 2024 – Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. announced today the attainment of the first milestone in a strategic partnership to advance the development of biomarkers for Alzheimer’s disease (AD) and other neurodegenerative conditions. This milestone marks a key achievement which provides Fujirebio access to clinical samples and data collected as part of the ongoing Phase 3 Alzheimer’s disease study, POLARIS-AD.

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Beckman Coulter and Fujirebio expand partnership to develop patient-friendly, blood-based neurodegenerative disease diagnostics

BREA, CALIF., and TOKYO, JAPAN, MARCH 12, 2024 — Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced an expansion of their partnership focused on development, manufacturing and clinical adoption of neurodegenerative disease assays.

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