🧠 A Simple Blood Test Could Help Detect Alzheimer’s Earlier

New FDA-cleared test makes early Alzheimer’s detection more accessible by using a blood sample instead of a spinal tap or PET scan. 🩸🧠

Published In: FDA News Release
Date: July 2025
Authors: FDA Announcement (Clearance to Fujirebio Diagnostics, Inc.)
Link to Study: FDA Press Release

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Summary

The FDA has approved the first blood test to aid in diagnosing Alzheimer’s disease, marking a major advance in early detection. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio measures specific proteins in the blood linked to amyloid plaques in the brain. This new, less invasive method could help clinicians identify Alzheimer’s-related changes earlier and more conveniently than traditional PET scans or spinal taps.

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Key Takeaways

✅ The test analyzes a simple blood sample to detect markers linked with Alzheimer’s disease.
✅ It showed over 90% accuracy compared to PET scans and spinal fluid tests.
✅ Easier and less invasive than current diagnostic methods.
✅ Useful for patients with signs of cognitive decline, but not intended for general screening.
✅ Approved under the FDA’s Breakthrough Device pathway due to its potential impact.

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Why It Matters for You

Early and accurate diagnosis is key to managing Alzheimer’s. This blood test could help more people access timely evaluations and treatments without undergoing complex procedures.

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Citation

FDA. (2025). FDA clears first blood test to aid in diagnosis of Alzheimer’s disease. U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-aid-diagnosis-alzheimers-disease