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Grant Award from GHIT Fund for Development of an Ultrasensitive Urine Test for Tuberculosis

H.U. Group Holdings, Inc. and its wholly-owned subsidiary Fujirebio Holdings, Inc. today announced that the Global Health Innovative Technology (GHIT) Fund has awarded a two-year, approximately $4.5 million grant to Fujirebio’s wholly-owned subsidiary, Fluxus, Inc. (Location: Sunnyvale, California), to develop an ultrasensitive point-of-care (POC) urine test for tuberculosis (TB). The test will utilize Fluxus’ novel single-molecule counting technology, with the potential to be used for both pulmonary and extrapulmonary TB in all patient populations.

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Fujirebio and Eisai Enter into Memorandum of Understanding for Joint Research and Social Implementation of Blood-based Biomarkers in the Field of Neurodegenerative Diseases

Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa; Head Office: Minato-ku, Tokyo), a wholly-owned subsidiary of H.U. Group Holdings, Inc. (Chairman, President and Group CEO: Shigekazu Takeuchi; Head Office: Minato-ku, Tokyo), and Eisai Co., Ltd. (Representative Corporate Officer and CEO: Haruo Naito; Head Office: Bunkyo-ku, Tokyo; hereinafter "Eisai") announced today that they have entered into a memorandum of understanding for the joint research and social implementation of novel blood-based biomarkers in the field of neurodegenerative diseases.

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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 the United States, and it will be available in Japan, 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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