Archive · 22 May 2025
FDA Approves Blood Test to Aid Alzheimer's Diagnosis
Alzheimer's disease affects many people, and early detection is crucial.
A new blood test has been approved by the FDA to help doctors diagnose the disease earlier.
This test looks for things called amyloid plaques in the blood, which are linked to Alzheimer's.
Unlike previous tests that needed a spinal tap, this new test only requires a simple blood draw, making it easier for patients.
This test is meant to help doctors, but it's not the only thing they'll use to diagnose Alzheimer's.
The FDA approved the first blood test to assist in diagnosing Alzheimer's disease.
The test identifies amyloid plaques, a key hallmark of Alzheimer’s, in adults aged 55 and older.
The test, Lumipulse G pTau217/ß-Amyloid 1-42, measures two proteins in blood plasma.
It aims to reduce the need for more expensive and invasive PET scans.
The FDA emphasizes the test should be used with other clinical evaluations.
- Who
- The US FDA and adults aged 55 and older experiencing cognitive decline.
- What
- The FDA approved the first blood test to help diagnose Alzheimer's disease by detecting amyloid plaques.
- When
- Recently
- Where
- United States
- Why
- To assist doctors in diagnosing Alzheimer’s disease earlier and more easily.
- Disease
- Alzheimer’s disease
- Regulatory Body
- The US FDA
- Test Type
- Blood test
- Target Age Group
- 55 and older
- Target
- Amyloid plaques
- Positive result accuracy
- 91.7%
- Negative result accuracy
- 97.3%