Beckman Coulter Diagnostics, a specialist in clinical diagnostics and a Danaher company, has received CE Mark under IVDR for its Acess p-Tau217 assay, a blood test designed to support the clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline
The company also introduced its high-specificity Acess 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-recognising markets.
Building on this clinical progress, the RUO assay is designed to further advance research into disease biology. Both assays are enabled by the Dxl Immunoassay Analyser, ensuring laboratories can efficiently manage clinical and research tests on a single high-precision analyser.
Scaling Access to Alzheimer’s Disease Blood Testing
The new CE Marked assay can measure phosphorylated tau (p-Tau217), a biomarker associated with Alzheimer’s disease, enabling scalable assessment in routine clinical settings.
Blood-based approaches can complement existing diagnostic pathways by providing an accessible, operationally scalable method for evaluating Alzheimer’s-related pathology in laboratory workflows.
Dr Chris Bird, chief medical officer at Beckman Coulter Diagnostics, said, “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. By making testing more accessible and operationally scalable, it helps integrate biomarker-based assessment into everyday clinical practice.”
The company developed the Access p-Tau217 assay using AlzPath’s antibody, which has been cited in over 200 peer-reviewed publications.
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.
Introducing High-Specificity Brain-Derived pTau217 Assay for Research Use
Beckman Coulter Diagnostics is also introducing its Access BD-pTau217 RUO assay, developed to selectively detect the short form pTau217 in blood samples using the Dxl 9000 Analyser.
Targeting the short form of pTau217 originating in the brain enables the new research assay to improve biological specificty and provide precise characterisation of central nervous system phosphorylated Tau217 signals in blood.
Dr Jeremiah Hinson, chief scientific officer for Neurodegenerative Diseases at Danaher, said, “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. 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.”
Early research findings suggest that greater biological specificity may improve the interpretability of biomarker detection in complex research datasets and support clearer differentiation of tau-related pathology in Alzheimer’s disease.
James Doecke, principal research scientist, Commonwealth Scientific and Industrial Research Organisation and the Australian Imaging, Biomarkers and Lifestyle (AIBL) Study of Ageing, said, “In the AIBL Study of Ageing, plasma pTau217 demonstrated strong performance as a blood‑based marker of Alzheimer’s pathology. When evaluated alongside amyloid and tau PET imaging, brain‑derived pTau217 showed additional biological specificity, particularly for research focused on tau‑related staging. These findings reinforce the role of pTau217 as a cornerstone biomarker while highlighting the potential value of higher biological specificity for improving clarity in Alzheimer’s disease research.”
Advancing Alzheimer’s Disease Testing
Beckman Coulter Diagnostics is advancing its Alzheimer’s disease portfolio with the Dxl 9000 Analyser, a scalable platform designed to consistently detect low-abundance biomarkers.
By enabling the CE-marked Access p-Tau217 assay and the Access BD-pTau217 (RUO), as well as existing Access GFAP (RUO), Access BD-Tau (RUO), Access NfL (RUO), Access Beta-Amyloid 1-42 (RUO), and Access apoE ε4 (RUO) assays to run on a common platform, laboratories can integrate diverse testing capabilities within a consistent, high-throughput workflow.
Dr Nick Culshaw, vice president and managing director, Clinical Chemistry and Immunoassay Business at Beckman Coulter Diagnostics, said, “High-sensitivity detection, robust assays, and operational scalability are critical as blood-based biomarkers become more widely adopted. 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 Analyser combines analytical sensitivity with operational flexibility, enabling laboratories to support a growing range of biomarker applications 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.
