Beckman Coulter Diagnostics has been awarded a CE Mark under IVDR for its Access p-Tau217 assay and unveiled its high-specificity Access BD-pTau217 Research Use Only (RUO) assay, according to an announcement.

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. Beckman Coulter Diagnostics developed the Access p‑Tau217 assay using AlzPath's antibody, cited in more than 200 peer‑reviewed publications.

The Access BD-pTau217 RUO assay will be introduced at the Alzheimer's Association International Conference (AAIC) 2026 in London and is designed to selectively detect the short form (or low molecular weight) pTau217 in blood samples using the DxI 9000 Analyzer. By targeting the short form of pTau217 originating in the brain, the new research assay is designed to enhance biological specificity and provide precise characterization of central nervous system phosphorylated Tau217 signals in blood.

Early research findings suggest that higher biological specificity may help improve interpretability of biomarker detection in complex research datasets and support clearer differentiation of tau-related pathology in Alzheimer's disease.

Both assays are enabled by the DxI 9000 Immunoassay Analyzer.

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