CA-FUJIREBIO/BECKMAN

Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today 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 burden of disability and deaths caused by neurological disorders is increasingly being recognized as a global public health challenge, and this burden is set to rise during the next few decades.ⁱ Currently, Alzheimer’s Disease International estimates over 55 million people worldwide are living with dementia and the number of people affected is set to rise to 139 million by 2050.ⁱⁱ With more than 100 disease modifying drug candidates under development, the pipeline for new therapeutics has never been more robust. The recent approval by the FDA of two monoclonal antibody-based therapeutics is a major milestone in improving patients‘ health and slowing down disease progression.

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 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.

Julie Sawyer Montgomery, President, Beckman Coulter Diagnostics and Danaher Diagnostics Group Executive, commented, “Combing the strengths of Fujirebio, the worldwide leader for neurodegenerative biomarker discovery and immunoassay development, with the global reach and high-sensitivity capabilities of Beckman Coulter’s immunoassay installed base means patients, neurologists and general medical practitioners will have unmatched accessibility to high-quality neurodegenerative assays the world over. We at Beckman Coulter Diagnostics believe access to blood-based tests is critical to Alzheimer’s Disease care.”

“This collaboration with Beckman Coulter will help accelerate the deployment of our portfolio of new, novel neurodegenerative biomarkers to laboratories and clinicians around the world. As the pre-eminent provider of leading-edge immunoassays to the diagnostics industry, this partnership is an important step to speed the transition of these markers from research to clinical use in all major geographies and to bring a higher standard of care to patients and their families in the battle against this debilitating disease,” stated Goki Ishikawa, President & CEO, Fujirebio Holdings, Inc.

This 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 recently introduced 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 cerebral spinal fluid (CSF) from patients being evaluated for Alzheimer’s Disease. Fujirebio has developed a full complement of research use only (RUO) blood-based neurodegenerative biomarkers including β-amyloid_1-42, β-amyloid_1-40, phospho-Tau₁₈₁, neurofilament light (NfL), ApoE4 and Pan-ApoE. Fujirebio is continuing to develop and expand our 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 U.S., Europe and Japan, with rapid development on Beckman Coulter’s large installed base of analyzers.

About Fujirebio

Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products.

Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated AD assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools.

More information can be found at www.fujirebio.com/neuro.

About Beckman Coulter. Inc.

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what’s now to what’s next. We do this by accelerating care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Beckman Coulter is part of the Danaher Corporation (NYSE:DHR) family of global science and technology companies. Headquartered in Brea, Calif., it has more than 11,000 global team members.

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ⁱ https://pubmed.ncbi.nlm.nih.gov/31813850/
ⁱⁱ https://www.alzint.org/about/dementia-facts-figures/dementia-statistics/

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