FDA Approves First Blood Test to Detect Alzheimer’s, Making Diagnosis Faster and Easier

The U.S. Food and Drug Administration (FDA) has approved the first blood test designed to detect Alzheimer’s disease, marking a major step toward quicker, less invasive diagnosis for millions of Americans.

Developed by Japan-based Fujirebio Diagnostics, the test identifies amyloid plaques in the brain — a key hallmark of Alzheimer’s — using a simple blood sample. Previously, diagnosing these plaques required PET brain scans or spinal fluid analysis, both of which are more expensive or invasive.

Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, noted that this approval could lead to earlier and more accessible diagnosis for patients. With nearly 7 million Americans currently living with Alzheimer’s — a number expected to nearly double by 2050 — the new test offers hope for faster detection and earlier intervention.

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