New CE-marked p-Tau217 test and research assay expand Alzheimer’s testing portfolio

Beckman Coulter Diagnostics has expanded its Alzheimer’s disease testing portfolio with a CE-marked blood test for p-Tau217 and a new research-use-only assay designed to provide greater insight into neurodegenerative disease biology.

The CE-marked Access p-Tau217 assay is designed to support the clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline across Europe and other CE-recognising markets. The company also introduced its Access BD-pTau217 Research Use Only (RUO) assay at the Alzheimer’s Association International Conference (AAIC) 2026 in London, providing researchers with a tool to study brain-derived pTau217 and tau pathology.

Both assays are powered by the DxI 9000 Immunoassay Analyser, enabling laboratories to perform clinical and research testing on a single high-throughput platform.

The Access p-Tau217 assay measures phosphorylated tau (p-Tau217), a biomarker associated with Alzheimer’s disease pathology. Blood-based testing approaches could complement existing diagnostic pathways by providing a more accessible and scalable method for assessing disease-related biomarkers within routine 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.

The company developed the assay using AlzPath’s antibody, which has been referenced in more than 100 peer-reviewed publications, supporting the scientific validation of p-Tau217 as an Alzheimer’s disease biomarker.

The newly introduced Access BD-pTau217 RUO assay is designed to selectively detect brain-derived p-Tau217 in blood samples. By targeting a specific form of the biomarker originating from the central nervous system, the assay aims to provide researchers with greater biological specificity when studying Alzheimer’s disease progression.

“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.

The expanded Alzheimer’s portfolio on the DxI 9000 Immunoassay Analyser enables laboratories to access a range of clinical and research biomarker assays through a single high-throughput platform. Alongside the CE-marked Access p-Tau217 assay and Access BD-pTau217 RUO assay, the portfolio includes Access GFAP (RUO), Access BD-Tau (RUO), Access NfL (RUO), Access Beta-Amyloid 1-42 (RUO) and Access apoE ε4 (RUO) assays.

Beckman Coulter Diagnostics said the portfolio expansion reflects the growing role of blood-based biomarkers in supporting both clinical assessment and research into Alzheimer’s disease.

More information online