On Friday, the United States approved the first blood test for Alzheimer’s disease, a decision that could help patients start treatment earlier with newly approved drugs that slow down the progression of devastating neurological disease.
The test, developed by Fujirebio Diagnostics, measures the ratio of two proteins in the blood. Rato is correlated with amyloid plates in the brain – a characteristic of Alzheimer’s which, so far, has only been detected by brain scans or an analysis of spinal liquids.
“Alzheimer’s disease has an impact on too many people – more than breast cancer and combined prostate cancer,” said Marty Makary, a Food and Drug Administration Commissioner.
“Knowing that 10% of people aged 65 and over have Alzheimer’s disease, and that in 2050 this number should double, I hope that new medical products such as it will help patients.”
There are currently two treatments approved by the FDA for Alzheimer’s disease: LecaneMab and Donanemab, which target the amyloid plate and have proven to be slightly slow cognitive decline, although they do not heal the disease.
Alzheimer’s disease has an impact on too many people, more than breast cancer and combined prostate cancer. Knowing that 10% of people aged 65 and over have Alzheimer’s disease, and that in 2050 this number should double, I hope that new medical products such as it will help… https://t.co/ku7a8xqgkz
– Dr Martin Makary (@drmakaryfda) May 16, 2025
Defenders of intravenous antibody therapies, including many neurologists, say they can offer patients for a few months of additional independence – and are probably more effective if they are launched earlier in the disease.
In clinical studies, the blood test produced results largely in accordance with the cerebral positron emission tomography (PET) and the analysis of the vertebral fluid.
“Today’s authorization is an important step for the diagnosis of Alzheimer’s, making it easier and potentially more accessible for American patients earlier in the disease,” said Michelle Tarver for the FDA devices and radiological health.
The test is authorized for clinical use for patients showing signs of cognitive decline, and the results should be interpreted alongside other clinical information.
Alzheimer’s disease is the most common form of dementia. It worsens over time, gradually flying to people with their memories and their independence.
© Agence France-Press
