Beckman Coulter Wins CE Mark for p-Tau217 Blood Assay

Beckman Coulter Diagnostics, a Danaher company, has received CE Mark under IVDR for its Access p-Tau217 blood assay for evaluating amyloid pathology in patients with signs of cognitive decline. Announced on 7 July 2026 at the Alzheimer’s Association International Conference (AAIC) in London, the launch is accompanied by a new high-specificity Research Use Only assay for brain-derived pTau217, both running on the DxI 9000 Immunoassay Analyzer.

The CE-marked Access p-Tau217 assay measures phosphorylated tau 217, a well-established Alzheimer’s biomarker, from routine blood samples rather than the cerebrospinal fluid or PET imaging pathways traditionally used to evaluate amyloid pathology. Beckman Coulter developed the assay using AlzPath’s antibody, cited in more than 200 peer-reviewed publications. Blood-based biomarker testing has emerged as a scalable alternative to CSF and PET for routine clinical practice, with the CE Mark expanding access across Europe and CE-recognising markets. Beckman Coulter has positioned the assay as its first clinical blood-based test for amyloid pathology in cognitive decline.

The new Access BD-pTau217 Research Use Only assay selectively detects the short-form (low molecular weight) pTau217 originating in the brain, providing enhanced biological specificity for characterising central nervous system tau signals in blood. Dr Jeremiah Hinson, Chief Scientific Officer for Neurodegenerative Diseases at Danaher, framed the assay as supporting more precise identification of tau pathology relevant to Alzheimer’s disease staging. Both assays run on Beckman Coulter’s DxI 9000 Immunoassay Analyzer, which already supports Access assays for GFAP, brain-derived Tau, NfL, Beta-Amyloid 1-42 and apoE ε4.

The commercial signal is a rapidly maturing Alzheimer’s blood-based diagnostics market being reshaped by therapy-driven demand. With Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla driving amyloid pathology testing volumes, expect intense competitive pressure from Roche Diagnostics’ Elecsys pTau assays, C2N Diagnostics’ PrecivityAD platform and Fujirebio’s Lumipulse. Beckman Coulter’s DxI 9000-anchored strategy strengthens Danaher’s competitive positioning across the neurodegenerative diagnostics category.

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