FDA Clears First Blood Test to Diagnose Alzheimer's Disease

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21-05-2025

The FDA greenlit marketing for the first blood test to help diagnose Alzheimer's disease
The test measures two proteins, beta-amyloid and p-tau217, which are hallmarks of the disease
Experts believe this will increase access to Alzheimer's detection and reduce reliance on expensive PET scans and invasive spinal tapsThe Food and Drug Administration has given marketing clearance to the first blood test to help diagnose Alzheimer's disease.
On May 16, the agency announced clearance of the test — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — manufactured by the Pennsylvania-based biotechnology company Fujirebio Diagnostics. The test works by measuring proteins beta-amyloid and p-tau217, which are believed to be hallmarks of Alzheimer's disease.
Alzheimer's is a degenerative brain disease that is caused by complex brain changes following cell damage. It progressively affects memory, thinking and behavior seriously enough to interfere with daily tasks.
The blood test was cleared for use in people age 55 and older who exhibit signs and symptoms of the disease. The FDA said this new test can help increase access to Alzheimer's disease detection and reduce reliance on PET scans or spinal taps, which are more expensive and invasive.
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'Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million,' Dr. Michelle Tarver, director of the Center for Devices and Radiological Health, said in a statement. 'Today's clearance is an important step for Alzheimer's disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.'
The FDA said that it conducted a study that evaluated 499 plasma samples from patients who were cognitively impaired and compared the results of the blood test with the results by PET scan or spinal tap.
Researchers found that the blood test was nearly 92% as accurate as a PET scan or spinal tap in detecting patients with Alzheimer's and over 97% as accurate in identifying patients who did not have the disease.
Dr. Richard Isaacson, a preventative neurologist who established one of the first Alzheimer's prevention clinics in the United States, told CNN that he has been using this blood test for years for research and applauded the FDA clearance.
'It can provide better clarity into whether a person experiencing memory loss may have Alzheimer's disease. They can take this test as a screening test,' he said. 'This is a much more simple screening test, with reasonable accuracy, to tell the physician that a person with cognitive decline has symptoms that are actually due to Alzheimer's disease.'
While the clearance is a step forward, Isaacson stressed that more research is necessary to determine how the blood test results should be interpreted and used to make medical decisions.
Read the original article on People