health · 3 outlets · 3 linked reports
Alzheimer's Blood Tests Arrive — Then Hit an Accuracy Setback
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Summary
- After the FDA cleared the first Alzheimer's blood test (Fujirebio's Lumipulse) in 2025 and a second from Roche and Eli Lilly followed, the tests promised a cheaper, less invasive alternative to spinal taps and PET scans for patients 55+ with memory problems.
- But in early 2026 the FDA issued a Class II recall on certain Lumipulse lots after data showed unexpectedly high false-positive rates — up to about 40% in one Mayo Clinic cohort — tied to a manufacturing issue.
- Experts say blood biomarkers remain promising but need careful validation before routine use.
The question
Blood tests will make early Alzheimer's diagnosis routine — once accuracy is nailed down.
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