FDA Approves Novel Blood Test for Alzheimer’s Detection

On May 16, 2025, the US Food and Drug Administration (FDA) granted Breakthrough Device designation for the first in vitro blood testing device to help diagnose Alzheimer’s disease: the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio by Fujirebio Diagnostics, Inc. The device detects amyloid plaques in adult patients aged 55 years or older who exhibit signs of the disease.

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