New Alzheimer's Blood Test Gets FDA Green Light

A new blood test designed to detect signs of Alzheimer's disease has received clearance from the U.S. Food and Drug Administration (FDA). The Elecsys pTau217, developed by Roche in collaboration with Eli Lilly, is intended for individuals aged 55 and older who are exhibiting cognitive decline.

This biomarker test assists physicians in determining the likelihood of Alzheimer's-related brain changes in patients. Its FDA clearance comes after it received similar approval in Europe in May. The test can be utilized on over 4,500 Roche laboratory analyzers already installed across the United States, potentially increasing widespread access.

Furthermore, Labcorp and Quest Diagnostics have announced their intention to offer the Elecsys pTau217 test through their respective laboratory networks. This move is expected to further expand the test's availability throughout the nation. This development occurs amidst a race among diagnostic companies to create simpler Alzheimer's detection methods, driven by a growing demand for earlier diagnosis and treatment.

Currently, detecting amyloid, a protein associated with Alzheimer's, often relies on PET scans or cerebrospinal fluid testing, which can be costly, invasive, and less accessible. The Elecsys pTau217 is not intended for standalone diagnosis and requires interpretation alongside other clinical information. Fujirebio's Lumipulse test was previously cleared by the FDA in 2025 to aid in Alzheimer's assessment.