Beckman Coulter and Fujirebio Partner to Widen Access to Blood-Based Alzheimer's Test

The increasing rate of disability and mortality due to neurological disorders is gradually being recognized as a significant global health issue, with the impact set to escalate in the forthcoming decades. Currently, Alzheimer's Disease International estimates that over 55 million people globally live with dementia, a figure projected to escalate to 139 million by 2050. With over 100 disease-altering drugs in the development pipeline, the potential for new therapeutics is greater than ever. The recent FDA approval of two monoclonal antibody-based treatments marks a significant breakthrough in improving Alzheimer's patients' health and slowing disease progression. Now, two companies are partnering to leverage their respective strengths in immunoassay to support the development of therapeutics, clinical trials, reimbursement, and standard clinical adoption in the field of neurodegenerative diseases.

Beckman Coulter, Inc. (Brea, CA, USA) and Fujirebio (Tokyo, Japan) have established a partnership that will capitalize on Fujirebio's skill in developing its pioneering, high-quality neurodegenerative disease biomarker assays and generating clinical evidence to boost clinical adoption. Beckman Coulter contributes its proprietary high-sensitivity detection capabilities and a wide base of immunoassay analyzers to facilitate global availability and support for the development of more accurate next-generation solutions. Fujirebio and Beckman Coulter aim to enhance access to patient-friendly, blood-based diagnostic capabilities to supplement and speed up the impact of pioneering Alzheimer's Disease therapeutics, complementing the current diagnostic solutions relying on PET-imaging or lumbar puncture for cerebral spinal fluid testing.

The growing prevalence of neurodegenerative diseases, coupled with advancements in disease-modifying therapies for Alzheimer's Disease, underscores the importance of the Beckman Coulter and Fujirebio partnership. This collaboration addresses the global need for blood-based Alzheimer's Disease diagnostics by expanding the menu on Beckman Coulter's Access Family of Immunoassay Analyzers, utilizing Fujirebio's assay technology. Initial assay development efforts will be focused on the recently introduced DxI 9000 Access Immunoassay Analyzer and the extensive installed base of Access Family Immunoassay Analyzers. The DxI 9000 Analyzer has demonstrated its potential to develop increasingly sensitive and clinically relevant assays, enabling the platform to keep up with the evolving testing needs as healthcare providers and pharmaceutical companies tackle challenging diseases, like Alzheimer's Disease.

Fujirebio holds the distinction of being the first company to gain FDA authorization for an in vitro diagnostic (IVD) test to evaluate β-amyloid pathology in patients' cerebral spinal fluid (CSF) being examined for Alzheimer's Disease. The company has developed a comprehensive array of blood-based neurodegenerative biomarkers for research use only (RUO), including β-amyloid1-42, β-amyloid1-40, phospho-Tau181, neurofilament light (NfL), ApoE4, and Pan-ApoE. By acquiring ADx NeuroSciences in June 2022, Fujirebio has added more biomarkers to its arsenal, broadening its portfolio. These new biomarkers offer clinical researchers the opportunity to delve deeper into the clinical relevance of evaluating Alzheimer's Disease or other neurological disorders. Fujirebio is set to validate the clinical efficacy of these blood-based neurodegenerative biomarkers, intending to shepherd them through the IVD regulatory procedures in the U.S., Europe, and Japan, leveraging Beckman Coulter's extensive installed base of analyzers for swift development.

"Combining 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," said Julie Sawyer Montgomery, President, Beckman Coulter Diagnostics and Danaher Diagnostics Group Executive.

"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," added Goki Ishikawa, President & CEO, Fujirebio Holdings, Inc.

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