Beckman Coulter Diagnostics expands Alzheimer’s disease portfolio with CE-marked p-Tau217 blood test and brain-derived research assay

Beckman Coulter Diagnostics has received a CE Mark under IVDR for its Access p-Tau217 blood test, and has launched a new high-specificity Access BD-pTau217 Research Use Only (RUO) assay at the Alzheimer’s Association International Conference (AAIC) 2026 in London, enabling laboratories across Europe and other CE-recognizing markets to scale blood-based Alzheimer’s disease testing and advance research into amyloid and tau pathology.

Expanding access to blood-based p-Tau217 testing in Europe

The CE-marked Access p-Tau217 assay is a blood test designed to support the clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline. By measuring phosphorylated tau (p-Tau217), a well-established biomarker associated with Alzheimer’s disease, the assay enables scalable assessment in routine clinical settings.

Blood-based approaches can complement existing diagnostic pathways by offering a more accessible and operationally scalable method for evaluating Alzheimer’s-related pathology within established laboratory workflows.

The CE Mark under IVDR represents a significant milestone in expanding access to blood-based p-Tau217 testing in Europe and additional CE-recognizing markets, providing laboratories and clinicians with an automated, high-throughput solution.

Beckman Coulter Diagnostics developed the Access p-Tau217 assay using AlzPath’s antibody, cited in more than 100 peer-reviewed publications, underscoring strong scientific validation. As demand for Alzheimer’s disease diagnostics grows, blood-based testing is expected to 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.

“By focusing on brain-derived pTau217, this assay is designed to deliver a higher level of biological specificity, helping researchers more precisely identify tau pathology in blood most relevant to their studies,” said Dr. Jeremiah Hinson, Chief Scientific Officer at Beckman Coulter Diagnostics.

“This increased specificity can bolster confidence in studying Alzheimer’s disease staging and support new insights into the biological inflection points that define how the disease evolves.”

Introducing a high-specificity brain-derived pTau217 assay for research

Alongside the CE-marked in vitro diagnostic (IVD) assay, Beckman Coulter Diagnostics has introduced its Access BD-pTau217 RUO assay, designed for high-specificity research applications. This assay selectively detects the short form (or low molecular weight) pTau217 in blood samples using the DxI 9000 Immunoassay Analyzer.

By targeting the short form of pTau217 originating in the brain, the Access BD-pTau217 RUO assay is designed to enhance biological specificity and provide precise characterization of central nervous system phosphorylated Tau217 signals in blood. This can support more detailed investigation of amyloid and tau pathology in neurodegenerative disease research.

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.

Advancing Alzheimer’s disease testing on the DxI 9000 Immunoassay Analyzer

Both the CE-marked Access p-Tau217 assay and the Access BD-pTau217 RUO assay are enabled by the DxI 9000 Immunoassay Analyzer, a highly sensitive, scalable platform designed to detect low-abundance biomarkers with consistency. This allows laboratories to manage both clinical and research tests on a single high-precision analyser.

By running the CE-marked Access p-Tau217 assay and the Access BD-pTau217 (RUO) alongside existing Access GFAP (RUO), Access BD-Tau (RUO), Access NfL (RUO), Access Beta-Amyloid 1-42 (RUO) and Access apoE ε4 (RUO) assays on a common platform, laboratories can integrate diverse neurodegenerative disease testing capabilities within a consistent, high-throughput workflow.

“High-sensitivity detection, robust assays, and operational scalability are critical as blood-based biomarkers become more widely adopted,” said Dr. Nick Culshaw, Vice President and Managing Director, Clinical Chemistry and Immunoassay Business at Beckman Coulter Diagnostics.

“By anchoring our Alzheimer’s disease portfolio on the DxI 9000 Analyzer, we are enabling laboratories to access an expanding set of biomarker insights, from clinical assessment to research applications, within a single system.”

The DxI 9000 Analyzer combines analytical sensitivity with operational flexibility, allowing laboratories to support a growing range of biomarker applications, from routine clinical evaluation to advanced research into disease biology, without compromising performance or efficiency. This unified platform approach helps ensure consistency in assay execution while enabling expansion into emerging markers across neurodegenerative diseases as scientific understanding evolves.

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