Roche Wins CE Mark for Elecsys pTau217 Blood Test to Detect Alzheimer's Amyloid Pathology in Routine Care
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SHERIDAN, WYOMING - May 13, 2026 - Roche has received CE Mark for Elecsys® pTau217, a blood-based diagnostic test designed to detect amyloid pathology associated with Alzheimer's disease, developed in collaboration with Eli Lilly and Company. The test measures phosphorylated Tau 217 protein from a routine blood draw and is intended to rule in or rule out amyloid pathology across both primary and secondary care settings using a single-assay design with unified cutoffs. The regulatory clearance positions Elecsys® pTau217 for deployment across Roche's installed base of laboratory instruments in CE mark-accepting countries, with potential FDA clearance in the United States under consideration for later this year.