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

On August 24, 2026, the FDA cleared Roche and Eli Lilly's Elecsys pTau217 blood test to identify Alzheimer's disease signs in patients aged 55 and older with cognitive decline. The test, which received European approval in May 2026, can run on 4,500 existing Roche analyzers. Labcorp and Quest Diagnostics plan to distribute it, expanding access to simpler testing amid competition with traditional, invasive PET scans.

FDA clearance Elecsys pTau217

• ▪Roche did not disclose the commercial price of the Elecsys pTau217 blood test upon receiving U.S. Food and Drug Administration clearance on August 24, 2026.
• ▪The Elecsys pTau217 blood test received European approval in May 2026 prior to obtaining U.S. Food and Drug Administration clearance.
• ▪The Elecsys pTau217 blood test can be run on more than 4,500 Roche laboratory analyzers already installed across the United States.
• ▪The U.S. Food and Drug Administration cleared Roche and Eli Lilly's Elecsys pTau217 blood test on August 24, 2026, to identify Alzheimer's disease signs in people aged 55 and older with cognitive decline.

Blood test versus PET scans

• ▪Roche stated that the Elecsys pTau217 blood test is not intended as a standalone diagnostic test and must be interpreted alongside other clinical information.
• ▪Traditional amyloid detection methods, such as positron emission tomography scans or cerebrospinal fluid testing, are often expensive, invasive, and less widely available than blood tests.

Alzheimer's biomarker testing market

• ▪Drugmakers and diagnostic companies are actively competing to develop simpler Alzheimer's disease tests due to rising demand for earlier diagnosis and treatment.
• ▪Fujirebio's Lumipulse became the first blood test cleared by the U.S. Food and Drug Administration to aid in Alzheimer's disease assessment in 2025.

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