US Edition
First FDA-Cleared Alzheimer’s Blood Test Could Make Diagnoses Faster, More Accurate
- Earlier this month, the FDA authorized the Lumipulse blood test by Fujirebio as the inaugural blood-based diagnostic tool in the United States for identifying Alzheimer’s disease in symptomatic adults aged 55 and older.
- This approval follows the need to replace expensive, invasive PET scans or spinal taps with a less invasive method measuring blood protein ratios linked to amyloid plaques, a key Alzheimer's marker.
- The test, authorized for clinical use alongside other tools, performed comparably to PET scans in trials and may enable earlier diagnoses, aiding timely access to newly approved amyloid-reducing drugs intended to slow disease progression.
- FDA Commissioner Marty Makary expressed optimism that innovative medical advancements like this will benefit patients, while experts anticipate the new blood test will boost the accuracy of primary care diagnoses from roughly 60% to more than 90%.
- This blood test's approval suggests a shift toward more accessible Alzheimer's diagnosis, especially benefiting those with mild symptoms, and may lead to broader testing and treatment in underserved areas.
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16 Articles
MedPage Today
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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…
A Drop of Blood to Detect Alzheimer’s Progression: How the New Test Approved in the US Works
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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