FDA Clears First Blood Test Used in Diagnosing Alzheimer's (May 2025)

Tier 1: Established: peer-reviewed research or government health authority
Publisher: U.S. Food and Drug Administration · Published: May 16, 2025 · Accessed: August 15, 2026

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Claims this source supports

• The FDA cleared the first blood test to aid in diagnosing Alzheimer's disease (May 16 2025): the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, which measures two proteins in plasma and calculates their ratio, correlated with the presence or absence of amyloid plaques in the brain.
• The test is indicated for adults aged 55 and older who are exhibiting signs and symptoms of the disease - it is not a screening test for asymptomatic people, and it does not diagnose Alzheimer's on its own; results must be considered alongside other evaluations.
• The clearance was supported by a multi-center clinical study of 499 plasma samples from cognitively impaired adults. The test offers a less invasive alternative to amyloid PET scans and lumbar puncture.
• The FDA estimates nearly 7 million Americans are living with Alzheimer's disease, projected to rise to nearly 13 million.