The US Food and Drug Administration has given marketing clearance to a blood test aimed at diagnosing Alzheimer’s disease in adults 55 years old and older. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test will help identify the presence of amyloid plaques in the brain, which are hallmarks of the disease.
Developed by Fujirebio Diagnostics Inc., the test measures two proteins in blood plasma: pTau217 and beta-amyloid 1-42. The ratio of these proteins tends to correlate with the occurrence or absence of amyloid plaques in the brain. While it does not directly measure amyloid, it can signal its presence.
The FDA clearance comes after clinical trial data showed that 91.7% of adults with positive test results had amyloid plaques confirmed by PET scans or cerebrospinal fluid tests. The agency emphasized the importance of assessing blood test results in conjunction with other clinical information from patients.
Experts hail this as a significant step forward for Alzheimer’s research, but also note that more work is needed to inform how blood test results should be interpreted and used to make clinical decisions.
Source: https://edition.cnn.com/2025/05/16/health/alzheimers-blood-test-fda-clearance