Beckman Coulter Diagnostics Expands Alzheimer's Portfolio with CE-Marked p-Tau217 Blood Test and New High-Specificity Research Assay

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CE-marked Access p-Tau217 blood test designed to support clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline across Europe Brain Derived pTau217 RUO assay selectively detects brain-derived pTau217 unlocking new neurodegenerative insights through high-specificity research of amyloid and tau pathology Powered by the DxI 9000 Immunoassay Analyzer, this expanding portfolio enables laboratories to provide diverse testing capabilities within a single, high-throughput, high sensitivity solution BREA, Calif., July 7, 2026 /PRNewswire/ -- Beckman Coulter Diagnostics, a global leader in clinical diagnostics and a Danaher company, today announced it received CE Mark under IVDR for its Access p-Tau217 assay, a blood test designed to support clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline. The company also introduced its high-specificity Access BD-pTau217 Research Use Only (RUO) assay at the Alzheimer's Association International Conference (AAIC) 2026 in London. The CE Mark represents a significant milestone in expanding access to blood-based p-Tau217 testing in Europe and additional CE-recognizing markets, supporting laboratories and clinicians with a scalable, automated solution. Building on this clinical progress, the newly launched RUO assay is designed to further advance research into disease biology. Both assays are enabled by the DxI 9000 Immunoassay Analyzer, ensuring laboratories can efficiently manage clinical and research tests on a single high-precision analyzer. Scaling Access to Alzheimer's Disease Blood Testing with CE-Marked, Automated p-Tau217 Assay The new CE Marked assay measures phosphorylated tau (p-Tau217), a well-established biomarker associated with Alzheimer's disease, enabling scalable assessment in routine clinical settings. Blood-based approaches can complement existing diagnostic pathways by offering a more accessible, operationally scalable method for evaluating Alzheimer's-related pathology within laboratory workflows. "Our CE-marked Access p-Tau217 assay brings a well-established Alzheimer's biomarker into routine clinical workflows, enabling laboratories to scale blood-based evaluation of disease pathology more efficiently," said Dr. Chris Bird, Chief Medical Officer at Beckman Coulter Diagnostics. "By making testing more accessible and operationally scalable, it helps integrate biomarker-based assessment into everyday clinical practice." Beckman Coulter Diagnostics developed the Access p‑Tau217 assay using AlzPath's antibody, cited in more than 200 peer‑reviewed publications, underscoring strong scientific validation. As demand for Alzheimer's disease diagnostics grows, blood‑based testing will play an increasingly important role in enabling consistent evaluation across clinical settings. This milestone marks the translation of validated biomarker science into Beckman Coulter's first clinical, blood‑based assay for amyloid pathology in patients with signs and symptoms of cognitive decline, accelerating the path from research insight to real‑world use.

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