Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced an expansion of their partnership focused on development, manufacturing and clinical adoption of neurodegenerative disease assays.

In 2023, Beckman Coulter and Fujirebio entered into a collaboration agreement focused on new biomarkers aligned with recently approved monoclonal antibody-based Alzheimer’s disease therapeutics. These new drugs are proving to be major milestones in slowing down disease progression and improving patients’ health. Today’s announcement extends this research program and further refines target analytes, including a pTau217 plasma assay being developed by Beckman Coulter and a Beta Amyloid 1-42 plasma assay being developed by Fujirebio.

These new assays are being developed for use on the recently introduced Beckman Coulter DxI 9000 Immunoassay Analyzer. The DxI 9000 Analyzer’s novel Lumi-Phos PRO Substrate has shown the capability to develop increasingly sensitive and clinically relevant assays.

This agreement leverages Fujirebio’s expertise in the development, manufacturing and regulatory registration of its Neurological Reagent Kits and its expansive Neurological Biomarker menu. 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, Pan-ApoE and phospho-Tau217.

Kevin O’Reilly, President, Beckman Coulter Diagnostics, commented, “We are very excited by our expanded partnership with Fujirebio designed to overcome challenges of developing highly sensitive assays, measuring ultra-low concentrations of neurodegenerative disease biomarkers circulating in the blood stream.”

“Our expanded partnership with Beckman Coulter will enable increased laboratory, clinician and patient access to more neurodegenerative biomarkers around the world,” stated Monte Wiltse, President & CEO, Fujirebio Diagnostics, Inc. “We look forward to continued collaboration with Beckman Coulter bringing these critical assays to physicians and patients worldwide.”

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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 Diagnostics

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 seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Headquartered in Brea, California, with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher. Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow’s science and technology to improve human health.

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Our expanded partnership with Beckman Coulter will enable increased laboratory, clinician and patient access to more neurodegenerative biomarkers around the world