FDA Approves Blood Test for Alzheimer's Disease
The US Food and Drug Administration (FDA) has cleared Roche's Elecsys pTau181 test, a blood-based biomarker test for Alzheimer's disease.
This test allows for earlier assessment and diagnosis, providing a broader understanding of when the disease can be ruled out.
- The test is intended for adults 55 and older in the United States who are showing signs or symptoms of cognitive decline.
- It can be used by primary care physicians to help identify patients who are unlikely to have Alzheimer’s disease.
- Those with a positive result would be recommended for further testing.
The test was developed in collaboration with Indianapolis-based Lilly.
Author's summary: FDA clears Roche's blood test for Alzheimer's disease diagnosis.