The United States on Friday approved the first blood test for Alzheimer’s, a move that could help patients begin treatment earlier with newly approved drugs that slow the progression of the devastating neurological disease.
The test, developed by Fujirebio Diagnostics, measures the ratio of two proteins in the blood.
“Alzheimer’s disease impacts too many people—more than breast cancer and prostate cancer combined,” said Food and Drug Administration Commissioner Marty Makary.
In clinical studies, the blood test produced results largely in line with positron emission tomography (PET) brain scans and spinal fluid analysis.
The test is authorized for use in clinical settings for patients showing signs of cognitive decline, and results must be interpreted alongside other clinical information.
In a move that could help patients start treatment earlier with recently approved medications that slow the progression of the debilitating neurological disease, the United States approved the first blood test for Alzheimer’s on Friday.
The Fujirebio Diagnostics-created test calculates the blood’s ratio of two proteins. The ratio is associated with brain amyloid plaques, a defining feature of Alzheimer’s disease that has only been identified up to this point by brain scans or spinal fluid analysis.
Food and Drug Administration Commissioner Marty Makary stated, “Alzheimer’s disease affects too many people—more than breast cancer and prostate cancer combined.”.
“I’m optimistic that new medical products like this one will benefit patients, especially since 10% of people 65 and older have Alzheimer’s, and that number is predicted to double by 2050. “.
Lecanemab and donanemab, two FDA-approved therapies for Alzheimer’s that target amyloid plaque, have been demonstrated to somewhat slow cognitive decline but not to reverse the disease.
Many neurologists who support intravenous antibody therapies claim that they can give patients a few more months of independence and that they will probably work better if initiated earlier in the course of the illness.
The blood test’s results in clinical trials were generally consistent with spinal fluid analysis and positron emission tomography (PET) brain scans.
According to Michelle Tarver of the FDA’s Center for Devices and Radiological Health, “Today’s clearance is an important step for Alzheimer’s diagnosis, making it easier and possibly more accessible for US patients earlier in the disease.”.
The test can be administered to patients exhibiting cognitive decline in a clinical setting, and the results need to be interpreted in conjunction with other clinical data.
Dementia most commonly manifests as Alzheimer’s. People gradually lose their memories and independence as it gets worse over time.
© 2025, AFP.
