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Jump to Key Points Aug 24 (Reuters) - The U.S. Food and Drug Administration has cleared Roche and partner Eli Lilly's blood test to help identify signs of Alzheimer's disease in people aged 55 and older with cognitive decline.
The test, Elecsys pTau217, is a biomarker blood test that can help doctors identify patients who are likely or unlikely to have Alzheimer's-related brain changes, Roche said on Monday.
The FDA clearance follows European approval for the test in May.
The test can be run on more than 4,500 Roche laboratory analyzers already installed across the United States, which the company said could help broaden access.
- FDA cleared Elecsys pTau217 for ≥55 y with cognitive decline.
- Blood test helps identify likely/unlikely Alzheimer-related brain changes.
- Not a standalone dx; interpret with other clinical info.
- May broaden access via >4,500 U.S. Roche analyzers.
- Labcorp, Quest plan network availability; price not disclosed.
Separately, Labcorp and Quest Diagnostics said that they plan to offer the test through their laboratory networks, potentially expanding availability across the United States.
Roche did not disclose the test's price.
Current methods to detect amyloid, a protein linked to the disease, typically rely on positron emission tomography or PET scans or cerebrospinal fluid testing, which can be expensive, invasive and less widely available.
The FDA clearance comes as drugmakers and diagnostic companies race to develop simpler tests for Alzheimer's disease amid growing demand for earlier diagnosis and treatment.
Fujirebio's Lumipulse became the first blood test cleared by the FDA to aid in the assessment of Alzheimer's disease in 2025.
Elecsys pTau217 is not intended to be used as a standalone diagnostic test and results should be interpreted alongside other clinical information, Roche said.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shinjini Ganguli)
