BREA, CALIF. & TOKYO -- 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.”