FDA clears Lilly-Roche blood test for Alzheimer’s amyloid-beta pathology
FDA clearance enables the Elecsys pTau217 blood test developed by Eli Lilly and Roche to detect amyloid-beta pathology in people aged 55 and older with signs of cognitive decline, supporting both rule-in and rule-out assessments in primary and specialty care. The approval points to broader Alzheimer’s diagnostic adoption as Lilly advances Phase 3 trials of donanemab.