UsAgainstAlzheimer's applauds FDA clearance of first blood test to diagnose Alzheimer's

UsAgainstAlzheimer's celebrates a major milestone with the U.S. Food and Drug Administration (FDA) clearance of the Lumipulse G pTau217/beta‐amyloid 1‐42 Plasma Ratio, the first‐ever clearance of a blood test to aid in diagnosing Alzheimer's disease, the May 19 news release stated. This major advancement provides a less invasive, faster, and more accessible way to detect the disease, offering hope to the millions of people affected by Alzheimer's. “For patients across the nation, this clearance removes a hurdle to bringing the test into everyday medical care,” said George Vradenburg, chairman and co‐founder of UsAgainstAlzheimer's. “In our surveys, about 25% of U.S. physicians reported that lack of FDA clearance was a barrier to them prescribing a blood test. Now, with a simple blood test that's fully cleared by the FDA, patients can get answers faster, with fewer barriers, and at a fraction of the cost. This is a game‐changer for patients, caregivers, and the millions of families affected by Alzheimer's.” One of the hallmarks of Alzheimer's disease is the buildup of amyloid plaques in the brain, which can now be detected using the new blood test. The test works by measuring two proteins in the blood — pTau217 and beta‐amyloid 1‐42 — that are linked to the presence of these plaques.

Publication Details

Journal
Mental Health Weekly
Published
2025-05-23
DOI
https://doi.org/10.1002/mhw.34467
Primary Topic
Biomedical Ethics and Regulation
Type
article
Field-Weighted Citation Impact
0.00
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article

UsAgainstAlzheimer's applauds FDA clearance of first blood test to diagnose Alzheimer's

Mental Health Weekly
Biomedical Ethics and Regulation
article

UsAgainstAlzheimer's applauds FDA clearance of first blood test to diagnose Alzheimer's

article en

Abstract

UsAgainstAlzheimer's celebrates a major milestone with the U.S. Food and Drug Administration (FDA) clearance of the Lumipulse G pTau217/beta‐amyloid 1‐42 Plasma Ratio, the first‐ever clearance of a blood test to aid in diagnosing Alzheimer's disease, the May 19 news release stated. This major advancement provides a less invasive, faster, and more accessible way to detect the disease, offering hope to the millions of people affected by Alzheimer's. “For patients across the nation, this clearance removes a hurdle to bringing the test into everyday medical care,” said George Vradenburg, chairman and co‐founder of UsAgainstAlzheimer's. “In our surveys, about 25% of U.S. physicians reported that lack of FDA clearance was a barrier to them prescribing a blood test. Now, with a simple blood test that's fully cleared by the FDA, patients can get answers faster, with fewer barriers, and at a fraction of the cost. This is a game‐changer for patients, caregivers, and the millions of families affected by Alzheimer's.” One of the hallmarks of Alzheimer's disease is the buildup of amyloid plaques in the brain, which can now be detected using the new blood test. The test works by measuring two proteins in the blood — pTau217 and beta‐amyloid 1‐42 — that are linked to the presence of these plaques.

Mental Health WeeklyVol. 35(21)
Openalex Percentile: Top 85%
Biomedical Ethics and Regulation
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