Beckman Coulter and Fujirebio Partner to Make Blood-Based Alzheimer's Test Available

21.09.2023 17:58

Beckman Coulter Diagnostics, a clinical diagnostics company, and Fujirebio, a neurological marker and in vitro diagnostic (IVD) manufacturing company, announced a new partnership that leverages their respective strengths in immunoassays to promote therapeutic 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. However, this burden will continue to increase over the next few decades.[i] According to current estimates from Alzheimer's Disease International, more than 55 million people worldwide are living with dementia and the number of those affected will increase to 139 million by 2050.[ii]

With more than 100 disease-controlling drug candidates in development, the pipeline for new therapeutics has never been more extensive. The FDA's recent approval of two monoclonal antibody-based therapeutics is an important milestone in improving the health of Alzheimer's patients and slowing the progression of the disease.

Increasing prevalence of neurodegenerative diseases

The new partnership between Beckman Coulter and Fujirebio is even more important given the increasing prevalence of neurodegenerative diseases and advances in the development of disease-modifying therapies for Alzheimer's disease. This joint project leverages Fujirebio's expertise in developing high-quality, first-to-market biomarker assays for neurodegenerative diseases and generating clinical evidence to advance clinical application. Beckman Coulter brings proprietary high-sensitivity detection methods and a broad installed base of immunoassay analyzers to promote global availability and support the development of better next-generation solutions.

To complement current diagnostic solutions that rely on PET imaging or lumbar puncture to examine cerebrospinal fluid, Fujirebio and Beckman Coulter intend to promote widespread access to patient-friendly, blood-based diagnostic options that complement the effectiveness of novel Alzheimer's therapies and accelerate.

Access to blood-based testing is critical for the treatment of Alzheimer's disease

Julie Sawyer Montgomery, President of Beckman Coulter Diagnostics and Danaher Diagnostics Group Executive, commented: “Combining the strengths of Fujirebio, the world leader in identifying biomarkers for neurodegenerative diseases and developing immunoassays with the global reach and highly sensitive Beckman Coulter's testing systems mean that patients, neurologists and general practitioners worldwide will have unprecedented access to high-quality testing for neurodegenerative diseases. At Beckman Coulter Diagnostics, we believe access to blood-based testing is critical to treating Alzheimer’s disease.”

“This collaboration with Beckman Coulter will help accelerate the delivery of our portfolio of new, innovative biomarkers for neurodegenerative diseases to laboratories and clinicians around the world. As a leader in pioneering immunoassays for the diagnostics industry, this partnership is an important step to accelerate the transition of these markers from research to clinical use in all major regions and provide a higher standard of care to patients and their families in the fight against this serious disease said Goki Ishikawa, President & CEO, Fujirebio Holdings, Inc.

Platform will keep pace with tomorrow's testing needs

This partnership aims to address the global unmet clinical need for blood-based Alzheimer's disease diagnostics through continued expansion of the testing range of Beckman Coulter's Access family of immunoassay analyzers leveraging Fujirebio's assay technology. Initial assay developments will focus on the recently launched DxI 9000 Access Immunoassay Analyzer and the widely available installed base of Access family of immunoassay analyzers. The DxI 9000 analytical system enables the development of increasingly sensitive and clinically relevant assays, enabling the platform to keep pace with the testing needs of tomorrow as healthcare providers and pharmaceutical companies target increasingly challenging diseases such as Alzheimer's disease.

Fujirebio is the first company to have its IVD test approved by the FDA to assess β-amyloid pathology using cerebrospinal fluid (CSF) from patients being evaluated for Alzheimer's disease. Fujirebio has developed a comprehensive range of blood-based research-grade neurodegenerative biomarkers (RUO), including β-Amyloid1-42, β-Amyloid1-40, Phospho-Tau181, Neurofilament Light Chain (NfL), ApoE4 and Pan-ApoE. Fujirebio continues to develop and expand our portfolio with additional biomarkers added as part of the recent acquisition of ADx NeuroSciences. The availability of these new biomarkers will provide clinical researchers with the opportunity to further investigate clinical utility in assessing Alzheimer's disease and other neurological conditions. Fujirebio plans to validate the clinical performance associated with the use of neurodegenerative biomarkers in blood and then undergo the IVD regulatory process in the US, Europe and Japan. The extensive installed base of analysis systems from Beckman Coulter acts as a platform for the rapid development of new solutions.

literature

[i] https://pubmed.ncbi.nlm.nih.gov/31813850/

[ii] https://www.alzint.org/about/dementia-facts-figures/dementia-statistics/