Beckman Coulter Diagnostics and Fujirebio, a provider in neurological markers and In Vitro Diagnostic manufacturing, are partnering to combine 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) 

The recent approval by the FDA of two monoclonal antibody-based therapeutics is a major milestone in improving Alzheimer’s patients’ health and slowing down disease progression.

This new joint effort relies on Fujirebio’s expertise in developing its neurodegenerative disease biomarker assays and generating the clinical evidence to drive clinical adoption. Beckman Coulter brings 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.

“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,” says Julie Sawyer Montgomery, president, Beckman Coulter Diagnostics and Danaher Diagnostics Group Executive, commented. “We at Beckman Coulter Diagnostics believe access to blood-based tests is critical to Alzheimer’s Disease care.”

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. 

“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,” says Goki Ishikawa, president & CEO, Fujirebio Holdings, Inc.

This partnership aims to address 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. 

Fujirebio obtained 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-amyloid1-42, β-amyloid1-40, 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.