Beckman Coulter Diagnostics, a leader in clinical diagnostics, and Fujirebio, a leader in neurological markers and in vitro diagnostics, announced today the formation of a new partnership. The two companies aim to combine their respective strengths in the field of immunoassays to support therapy development, clinical trials, reimbursement and routine clinical use in the field of neurodegenerative diseases.

The burden of disability and death caused by neurological diseases is increasingly recognized as a global public health challenge, and this burden will only increase in the coming decades. i The organization Alzheimer's Disease International estimates that more than 55 million people worldwide are currently living with dementia, and by 2050 the number of people affected will increase to 139 million. iiWith more than 100 disease-modifying drug candidates in development, the pipeline for new therapeutics has never been more robust. The recent FDA approval of two monoclonal antibody therapeutics is an important milestone in improving patient health and slowing disease progression.

With the increasing prevalence of neurodegenerative diseases and advances in disease-modifying therapies for Alzheimer's disease, the new partnership between Beckman Coulter and Fujirebio becomes increasingly important. This collaborative effort leverages Fujirebio's expertise in developing its first-to-market high-quality biomarker assays for neurodegenerative diseases and providing the clinical evidence to advance its use in the clinic. Beckman Coulter brings proprietary, highly sensitive detection methods and a broad installed base of immunoassay analyzers to drive global availability and support the development of even more accurate next-generation solutions.

Julie Sawyer Montgomery, President of Beckman Coulter Diagnostics and Group Executive of Danaher Diagnostics, commented, “Combining the strengths of Fujirebio, the world leader in neurodegenerative biomarker discovery and immunoassay development, with its global reach and highly sensitive capabilities The capabilities of Beckman Coulter's installed immunoassay base opens up the possibility that patients, neurologists and general practitioners around the world will have access to high-quality assays for neurodegenerative diseases that were previously unattainable. At Beckman Coulter Diagnostics, we believe that access to blood-based testing is critical to treating Alzheimer's disease."

“This collaboration with Beckman Coulter will help accelerate our delivery of our portfolio of new and novel neurodegenerative disease biomarkers to laboratories and clinicians worldwide. For us, as the pre-eminent provider of cutting-edge immunoassays to the diagnostics industry, this partnership is an important step to accelerate the translation of these markers from research to clinical practice in all major geographies, and unite patients and their families in the fight against this devastating disease to provide a higher standard of care,” said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc.

This partnership is designed to address the unmet clinical need worldwide for blood-based Alzheimer's diagnostics through the continued expansion of Beckman Coulter's Access family of immunoassay analyzers using Fujirebio's assay technology. Initial assay development work will focus on the recently released DxI 9000 Access immunoassay analyzer and the widespread installed base of Access family immunoassay analyzers. The DxI 9000 has demonstrated its ability to support the development of increasingly sensitive and clinically relevant assays, allowing this platform to keep pace with tomorrow's testing needs,

Fujirebio was the first company to receive FDA approval for an in vitro diagnostic (IVD) test for the evaluation of β-amyloid pathology using cerebrospinal fluid (CSF) from patients being evaluated for Alzheimer's disease. had received. Fujirebio has developed a whole series of blood-based biomarkers for neurodegenerative diseases, which may only be used for research purposes (Research Use Only, RUO), including β-amyloid 1-42 , β -amyloid 1-40 , phospho-tau 181, Neurofilament Light (NfL), ApoE4 and Pan-ApoE. Fujirebio continues to develop and expand its offering with additional biomarkers acquired through the recent acquisition of ADx NeuroSciences. The availability of these new biomarkers will allow clinical research professionals to further investigate the clinical utility in the assessment of Alzheimer's disease or other neurological disorders. Fujirebio intends to validate the clinical performance of blood neurodegenerative disease biomarkers and bring these biomarkers through the IVD registration process in the US, Europe and Japan, with rapid development using Beckman Coulter's large installed base of analyzers .

 

Source:businesswire.com

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