FDA Approves First Blood Test for Alzheimer's Disease in the US
The US has approved the first blood test for Alzheimer's, enabling earlier detection through a simple blood analysis that measures specific proteins linked to the disease, potentially transforming diagnosis and treatment.
In a groundbreaking development, the United States has approved the first blood test capable of detecting Alzheimer's disease, representing a significant advancement in early diagnosis and treatment. Developed by Fujirebio Diagnostics, this innovative test measures the ratio of two specific proteins in the bloodstream. This protein ratio correlates with amyloid plaques in the brain, which are characteristic of Alzheimer's. Traditionally, detecting these plaques involved brain scans or cerebrospinal fluid analysis, both of which are more invasive or expensive.
The significance of this blood test lies in its potential to make early diagnosis more accessible and less invasive. According to FDA Commissioner Marty Makary, Alzheimer's disease affects more individuals than breast and prostate cancers combined. With over 10% of those aged 65 and older affected, and estimates suggesting that this number could double by 2050, the anticipation is that such diagnostic tools could revolutionize patient care.
Currently, two treatments—lecanemab and donanemab—are FDA-approved and target amyloid plaques to modestly slow cognitive decline, although they do not cure the disease. Experts believe that starting treatment early, aided by reliable diagnostics like this blood test, could help preserve brain function longer and extend independence.
Clinical studies comparing this blood test to PET scans and cerebrospinal fluid tests have shown promising results, matching the accuracy of these more invasive methods. The FDA has authorized use of this test in clinical settings for patients showing signs of cognitive decline, emphasizing that results should be interpreted alongside other clinical information.
Alzheimer's is the most common form of dementia, gradually impairing memory and independence over time. The approval of this blood test marks an important step toward earlier detection, better treatment planning, and ultimately, improved patient outcomes.
Source: https://medicalxpress.com/news/2025-05-blood-alzheimer.html
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