The Access p-Tau217 assay is designed for integration into routine laboratory workflows, offering a scalable method to evaluate Alzheimer's-related biomarkers. By utilizing the DxI 9000 Immunoassay Analyzer, the test aims to improve the consistency and accessibility of blood-based diagnostics. According to Dr. Chris Bird, Chief Medical Officer at Beckman Coulter, the approval marks a shift in moving validated biomarker science from research settings into everyday clinical practice.
Beckman Coulter Launches CE-Marked Alzheimer's Blood Test in Europe
Beckman Coulter Diagnostics has secured CE Mark approval for its Access p-Tau217 blood test, providing European clinicians with an automated tool for detecting amyloid pathology in patients showing cognitive decline. The company unveiled the assay alongside a new high-specificity research test at the 2026 Alzheimer’s Association International Conference in London.
Simultaneously, the company introduced the Access BD-pTau217 Research Use Only assay. This tool focuses on identifying the short form of pTau217 originating in the brain, which researchers believe provides higher biological specificity for tracking disease staging. Dr. Jeremiah Hinson, Chief Scientific Officer for Neurodegenerative Diseases at Danaher, noted that this precision helps in characterizing central nervous system signals, potentially offering clearer insights into how Alzheimer’s pathology evolves. Both the clinical and research tests are supported by the DxI 9000 platform, allowing laboratories to manage diverse neurodegenerative testing needs within a single high-throughput system.
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