Roche’s Elecsys pTau217 blood test for Alzheimer’s disease assessment has secured US Food and Drug Administration (FDA) clearance.
Developed in collaboration with Eli Lilly, Elecsys pTau217 is designed to provide clinicians with a single blood-based option to aid to identify amyloid pathology associated with Alzheimer’s disease in individuals 55 years and older who are displaying signs and symptoms of cognitive decline. FDA clearance for the test follows its receipt of a European CE mark in May 2026.