Roche receives FDA clearance for Elecsys® pTau217, advancing Alzheimer's disease assessment across primary and specialty care

Roche receives FDA clearance for Elecsys® pTau217, advancing Alzheimer's disease assessment across primary and specialty care

PR Newswire

INDIANAPOLIS, Aug. 24, 2026

First and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology across primary and specialty care settingsThe test delivers consistency across clinical settings by using the same validated cutoffs in primary and specialty care Designed for broad implementation across Roche's installed base of more than 4,500 cobas laboratory instruments in the U.S. supporting access through existing laboratory infrastructureINDIANAPOLIS, Aug. 24, 2026 /PRNewswire/ -- Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has cleared the Elecsys® Phospho-Tau (217P) Plasma (pTau217) blood test, providing clinicians across primary and specialty care with a single blood-based option to aid in identifying amyloid pathology associated with Alzheimer's disease in individuals 55 years and older with signs, symptoms, or complaints of cognitive decline.4 Developed in collaboration with Eli Lilly and Company, Elecsys pTau217 is the first and only FDA-cleared, single-biomarker blood test that supports both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings.