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

The US Food and Drug Administration has cleared a blood test developed by Roche (RHHBY) and Eli Lilly (LLY) to help identify signs of Alzheimer's disease in patients aged 55 and older experiencing cognitive decline, marking another step in the industry's push to make diagnosis simpler and more accessible.

The test, Elecsys pTau217, is a biomarker assay designed to help clinicians determine whether a patient is likely or unlikely to have Alzheimer's-related brain changes. The FDA clearance follows European approval granted in May. Roche said the test can be run on more than 4,500 of its laboratory analyzers already installed across the United States, a factor the company said should support broader access. No pricing was disclosed.

Labcorp (LH) and Quest Diagnostics (DGX) separately said they intend to offer the test through their respective laboratory networks, potentially extending its reach further across the country.

The clearance arrives as drugmakers and diagnostics companies intensify efforts to develop simpler tools for Alzheimer's detection, driven by rising demand for earlier diagnosis and the emergence of disease-modifying treatments. Current methods to detect amyloid — a protein associated with the disease — typically rely on positron emission tomography scans or cerebrospinal fluid testing, both of which can be costly, invasive and difficult to access.

Fujirebio's Lumipulse was the first blood test cleared by the FDA to aid in the assessment of Alzheimer's disease, receiving that designation in 2025. Roche cautioned that Elecsys pTau217 is not intended as a standalone diagnostic and that results should be interpreted in conjunction with other clinical information.