FDA Clears First Alzheimer's Blood Test With 90% Accuracy for Clinical Use
Updated
Updated · skeptic.com · Jun 30
FDA Clears First Alzheimer's Blood Test With 90% Accuracy for Clinical Use
3 articles · Updated · skeptic.com · Jun 30
Summary
The FDA has cleared the first blood test for Alzheimer’s pathology, allowing clinicians to use a p-tau217 assay that studies in 2024 showed was about 90% accurate.
The test offers a cheaper, less invasive alternative to PET scans and spinal taps, potentially speeding diagnosis for patients already showing symptoms and helping families plan care earlier.
Its usefulness is narrower than the headline suggests: guidelines do not endorse screening healthy people, and roughly 1 in 5 results can still fall into an indeterminate gray zone.
The clearance lands as anti-amyloid drugs Leqembi and Kisunla remain contested—approved after slowing decline only modestly while carrying risks such as brain swelling and bleeding.
The broader shift is from post-mortem certainty toward diagnosis in living patients, though doctors still struggle to distinguish Alzheimer’s from other dementias such as Lewy body and frontotemporal disease.
New blood tests can predict Alzheimer's years early. Is society ready for the 'trap of knowing'?
After decades focused on a flawed theory, where will the search for a dementia cure go now?
The Lumipulse Blood Test: FDA-Approved Breakthrough for Accessible and Accurate Alzheimer’s Diagnosis
Overview
The FDA’s clearance of the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio assay in May 2025 marks a major breakthrough in Alzheimer’s disease diagnosis. As the first approved blood test for this purpose, Lumipulse measures key protein ratios in blood to indicate the presence of amyloid plaques, a hallmark of Alzheimer’s. This test offers a less invasive and more accessible alternative to traditional methods like PET scans or spinal taps. Its strong clinical performance and potential to streamline diagnosis promise earlier detection and improved patient care, while also raising important considerations about accessibility, cost, and ethical use.