The U.S. Food and Drug Administration has granted clearance to Roche and Eli Lilly's Elecsys pTau217 blood test, a biomarker tool designed to identify signs of Alzheimer's disease in patients aged 55 and older experiencing cognitive decline.
The test, which received European regulatory approval in May, is intended to help clinicians determine whether patients are likely or unlikely to exhibit Alzheimer's-related brain changes. Roche did not disclose the test's pricing, though it noted the assay can be run on more than 4,500 Roche laboratory analyzers already deployed across the United States.
Labcorp and Quest Diagnostics said they plan to offer the Elecsys pTau217 test through their laboratory networks. Current diagnostic methods, such as positron emission tomography scans or cerebrospinal fluid testing, remain expensive, invasive, and less accessible, according to industry observers.
The FDA clearance was announced on Monday, August 24, 2026.
