FDA clears Roche and Eli Lilly's blood test for early Alzheimer’s detection

The U.S. FDA has granted clearance for a new blood test developed by Roche and Eli Lilly that measures phosphorylated tau 217 (pTau217) to help rule in or rule out Alzheimer’s disease.

The Elecsys pTau217 assay, which received a CE mark in Europe earlier this year, detects the buildup of amyloid plaques in individuals aged 55 and older who show signs of cognitive decline, potentially allowing earlier assessment in the diagnostic pathway.

Laboratory service providers Labcorp and Quest Diagnostics said they will make the test available to clinicians, expanding access to the biomarker‑based diagnostic tool.

The clearance follows earlier FDA approval of Fujirebio’s Lumipulse test in 2025, marking a growing portfolio of in‑vitro diagnostic blood tests for Alzheimer’s.