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FDA greenlights marketing of first Alzheimer's blood test for some patients

FDA greenlights marketing of first Alzheimer's blood test for some patients

CBSN
Friday, May 16, 2025 08:27:01 PM UTC

The Food and Drug Administration has greenlit Japan-based test manufacturer Fujirebio to begin marketing its blood test for helping doctors diagnose Alzheimer's disease in some patients, clearing the way for wider availability of the approach. 

Fujirebio's test works with the company's Lumipulse equipment, which the company says is already "widely available in clinical laboratories" around the U.S. Fujirebio describes Lumipulse as a "fully automated" system that can run 120 tests an hour on blood and other samples.

The test works by measuring two kinds of proteins in the blood that are associated with whether the brain has built up amyloid plaques, which research has linked to Alzheimer's disease. 

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