NEW YORK – Beckman Coulter and Fujirebio announced on Monday that they are partnering to develop blood-based tests for Alzheimer's disease.
Through the partnership, Fujirebio will develop tests on Beckman Coulter's Access portfolio of immunoassay analyzers, with the initial focus on the firm's Dxl 9000 Access Immunoassay Analyzer, the companies said in a statement. Fujirebio will validate the clinical performance of neurodegenerative markers in blood and bring them through regulatory processes in the US, Europe, and Japan, along with rapid development on Danaher subsidiary Beckman Coulter's installed base of analyzers.
The partnership is also intended to increase access to blood-based Alzheimer's testing, complementing and accelerating the impact of Alzheimer's therapeutics, the companies said. Recent Alzheimer's drug approvals, such as Biogen's Aduhelm (aducanumab) and Eisai's Leqembi (lecanemab), have sparked particular interest in blood-based testing for Alzheimer's disease.
"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," Fujirebio President and CEO Goki Ishikawa said in a statement. The 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."
Fujirebio was the first company to receive de novo classification from the US Food and Drug Administration for a test for the early detection of amyloid plaques associated with Alzheimer's disease.