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First FDA-Cleared Alzheimer’s Blood Test Could Make Diagnoses Faster, More Accurate
- The FDA cleared Fujirebio Diagnostics' Lumipulse blood test in May 2025 to detect Alzheimer's disease in people with cognitive symptoms in the United States.
- This approval responds to the need for less invasive and costly alternatives to PET scans and spinal taps that previously confirmed Alzheimer's by detecting amyloid plaques.
- The test measures the ratio of amyloid and tau proteins in blood and performed comparably to established imaging and spinal fluid tests during clinical trials.
- FDA Commissioner Makary expressed optimism that innovative medical treatments will benefit patients, as earlier detection allows for timely use of recently approved medications that can slow the progression of the disease.
- The test could expand timely Alzheimer's diagnoses, improve accuracy beyond current primary care rates of about 60%, and promote more equitable access to care.
17 Articles
17 Articles
MedPage Today
Anti-Aging, Acupuncture and Health NewsMedPod Today: Alzheimer's Blood Test; Vax Claims Debunked; Top GLP-1 for Weight Loss
(MedPage Today) -- The following is a transcript of the podcast episode: Rachael Robertson: Hey everybody. Welcome to MedPod Today, the podcast series where MedPage Today reporters share deeper insight into the week's biggest healthcare stories...
Scientists find 16 new Alzheimer’s-linked genes using multi-ancestry genome data
A new study published in Alzheimer’s & Dementia has identified 16 novel genetic regions associated with Alzheimer’s disease by analyzing whole genome sequencing data from a large, ethnically diverse group of individuals. The findings emphasize the importance of including underrepresented populations in genetic research and point to new biological pathways that may play a role in the development of the disease. Alzheimer’s disease is the most com…
US Approves First Blood Test for Alzheimer’s in Major Diagnostic Breakthrough - One Green Planet
A new FDA-approved blood test could help diagnose Alzheimer’s earlier—without the need for brain scans or spinal taps. The post US Approves First Blood Test for Alzheimer’s in Major Diagnostic Breakthrough appeared first on One Green Planet.
Herald/Review Media
BizTocA Blood Test for Alzheimer’s: What to Know
A blood test that can help diagnose Alzheimer’s disease has received clearance from the Food and Drug Administration. This is a step toward a goal of scientists and doctors to one day be able to diagnose a confounding illness with…
While the FDA-supported device is not for massive or preventive use, it is a key step in identifying early signs of the disease that accounts for 60% to 70% of dementia cases. For whom it is indicated and how it is applied
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