Roche's Elecsys pTau217 blood test, co-developed with Eli Lilly, received CE-mark approval in Europe on May 12, 2026.
This is the second Alzheimer's blood test approved in Europe, following the earlier pTau181 test.
pTau217 offers both rule-in and rule-out capabilities for Alzheimer's, unlike pTau181 which mainly rules out amyloid pathology.
Validated for use in both primary and specialist care settings.
Expected availability in CE-marked European markets starting July 2026.
Has breakthrough device designation from the U.S. FDA.