Beckman Coulter and Fujirebio bolster Alzheimer’s disease therapeutics
The partnership seeks to expand access to patient-friendly diagnostics
16 Jul 2023
Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and in vitro diagnostic (IVD) manufacturing, have announced a new partnership combining their respective immunoassay strengths to support therapeutic development, clinical trials, reimbursement, and routine clinical adoption in the field of neurodegenerative diseases.
The intersection of the growing prevalence of neurodegenerative disease and advances in disease-modifying therapies for Alzheimer’s disease makes the new Beckman Coulter and Fujirebio partnership evermore critical. This joint effort relies on Fujirebio’s expertise in developing its first-to-market, high-quality neurodegenerative disease biomarker assays and generating the clinical evidence to drive clinical adoption. Beckman Coulter brings proprietary high-sensitivity detection capabilities and a broad installed base of immunoassay analyzers to drive global availability and support for development of more accurate next-generation solutions.
To complement the current diagnostic solutions, which rely on PET-imaging or a lumbar puncture for cerebral spinal fluid (CSF) testing, Fujirebio and Beckman Coulter intend to bolster widespread access to patient-friendly, blood-based diagnostic capabilities which will complement and accelerate the impact of breakthrough Alzheimer’s disease therapeutics.
The partnership addresses the global unmet clinical need for blood-based Alzheimer’s disease diagnostics through continued menu expansion on Beckman Coulter’s Access Family of Immunoassay Analyzers leveraging Fujirebio’s assay technology. Initial assay development efforts will focus on the DxI 9000 Access Immunoassay Analyzer and the widespread installed base of Access Family Immunoassay Analyzers. The DxI 9000 Analyzer has shown capability to develop increasingly sensitive and clinically-relevant assays enabling the platform to keep pace with tomorrow’s testing requirements as healthcare providers and pharmaceutical companies take aim at evermore challenging diseases, like Alzheimer’s disease.
Fujirebio was the first company to obtain an FDA authorized in vitro diagnostics (IVD) test for the assessment of β-amyloid pathology using CSF from patients being evaluated for Alzheimer’s disease. It has developed a full complement of research use only (RUO) blood-based neurodegenerative biomarkers including β-amyloid1-42, β-amyloid1-40, phospho-Tau181, neurofilament light (NfL), ApoE4 and Pan-ApoE.
Fujirebio is continuing to develop and expand its menu with additional biomarkers obtained through the recent acquisition of ADx NeuroSciences. The availability of these new biomarkers allows clinical research professionals to further investigate clinical utility in assessing Alzheimer’s disease or other neurological disease conditions. Fujirebio intends to validate the clinical performance of using neurodegenerative biomarkers in blood and bring them through the IVD regulatory process in the US, Europe and Japan, with rapid development on Beckman Coulter’s large installed base of analyzers.