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Fujirebio receives marketing clearance 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

- First Blood-Based In-Vitro Diagnostic Test to Receive FDA Clearance for Patients Being Assessed for Alzheimer’s Disease.
- Availability of Accurate, Accessible, Blood-Based Diagnostic Tests Will Aid in Development and Availability of More Effective Interventions for Alzheimer’s Disease.

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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 Europe launches the INNO-LiPA® HCV 2.0 Genotyping assay, an efficient aid to personalized HCV therapy

Fujirebio Europe today announced the availability* of the INNO-LiPA HCV 2.0 Genotyping assay. The product, previously distributed by Siemens Healthcare Diagnostics Inc. under the name VERSANT HCV Genotype 2.0, is a line probe assay, for in vitro diagnostic use, designed for the qualitative detection and identification of Hepatitis C virus (HCV) genotypes 1 to 6 and subtypes a and b of genotype 1 in human serum or EDTA plasma samples. Additional subtype information is available in a majority of cases.

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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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