Articles from FUJIREBIO

Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer’s Disease (AD).

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.

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.

ADx NeuroSciences, a wholly owned subsidiary of Fujirebio and a leader in neurodegenerative disease biomarker development, and Alamar Biosciences, a leader in ultra-sensitive immunoassay technologies, today announced a partnership in the development of customized biomarker assay solutions using Alamar’s NULISA™ (Nucleic Acid Linked Immuno-Sandwich Assay) immunoassay platform and ARGO™ HT System. This collaboration aims to provide advanced tools for the detection and quantification of critical biomarkers to support neurological disease therapeutic development.

Fujirebio today announced that its wholly-owned subsidiary Fujirebio Diagnostics, Inc. has filed its Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test with the U.S. Food and Drug Administration (FDA). The new plasma test is expected to be the first commercially available blood-based IVD test in the U.S. to help in the assessment of Alzheimer’s disease (AD).

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.

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.

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.

Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd today announced that they have entered into an agreement of Contract Development and Manufacturing Organization (CDMO) partnership for Cartridge based CLIA system reagents manufacturing project for the immunology equipment Mispa i60 and Mispa i121. Notably, the analyzers and reagents will be sold under Agappe’s brand, making Agappe the first Indian local company with a complete Chemiluminescence Solution comprising locally manufactured reagents.

H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes.

Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa) and Sysmex Corporation (President: Kaoru Asano) today announced that they have signed an agreement for the mutual supply of reagent raw materials owned by both companies (“the Agreement”). The Agreement is based on a basic agreement on business collaboration in the field of immunoassay*1 which the two companies signed in October 2023.

H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G NfL CSF and Lumipulse G NfL Blood assays for the fully automated random-access LUMIPULSE® G immunoassay systems. These CLEIA (chemiluminescent enzyme immunoassay) assays allow for the quantitative measurement of Neurofilament light (NfL) in human Cerebrospinal fluid (CSF) and plasma/serum, respectively, within just 35 minutes. The two assays are available for Research Use Only.

H.U. Group Holdings Inc., and its wholly-owned subsidiary Fujirebio, today announced an agreement with the Diagnostics Accelerator initiative of the Alzheimer's Drug Discovery Foundation (ADDF) to accelerate the development of a plasma pTau181 detection assay on the fully automated LUMIPULSE® G immunoassay platform. pTau is recognized as an important fluid biomarker linked to the diagnosis of Alzheimer’s disease (AD). The ADDF Diagnostics Accelerator initiative is part of a collaboration with Gates Ventures and other philanthropic partners.