Medical Revolution: Simple Blood Test Could Detect Alzheimer's Earlier

The test developed by Fujirebio Diagnostics is based on the analysis of the levels of two proteins in the blood. Their mutual ratio reflects the presence of amyloid plaques in the brain – a characteristic biomarker of Alzheimer's disease.

Breakthrough in the Fight Against Alzheimer's Disease: Blood Test to Replace Expensive Imaging Tests

Until now, confirmation of the presence of these changes was only possible using expensive and difficult to access tests, such as positron emission tomography (PET) or cerebrospinal fluid analysis, which requires a lumbar puncture.

“Today’s approval is an important step forward in Alzheimer’s disease diagnostics, making them easier and potentially more accessible to American patients at an earlier stage of the disease,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health.

The test is intended for patients who are already showing symptoms of cognitive decline. The test results should be interpreted in the context of other clinical data, but its availability gives hope for earlier treatment before irreversible brain damage occurs.

The statistics leave no illusions

Alzheimer's disease affects millions of people worldwide and is the most common cause of dementia. About 10 percent of people aged 65 and older have the disease, according to U.S. health authorities.

“ Alzheimer’s disease affects far too many people—more than breast and prostate cancer combined,” said FDA Commissioner Marty Makary. “Given that 10 percent of people age 65 and older have Alzheimer’s disease, and that number is expected to double by 2050, I’m hopeful that new medical products like this will help patients.”

Medicines are already available – now it's time for effective diagnoses

The FDA has approved two drugs to date for Alzheimer’s disease: lecanemab and donanemab. Both are monoclonal antibody therapies that aim to eliminate amyloid plaques.

While they can't cure the disease, they have been shown to slightly slow the loss of cognitive function. Neurologists point out that the effectiveness of these therapies increases if treatment is started early in the disease.

“Intravenous antibody therapies can offer patients several extra months of independence,” experts say, “and are likely to be more effective if started earlier in the disease course.”

FDA approval supported by clinical trials

The new blood test was approved based on clinical trials that showed high agreement between the results and PET and CSF tests, confirming its reliability as a diagnostic aid.

“This is not only a technological breakthrough, but also a milestone towards making Alzheimer’s diagnostics more widely available,” say doctors.

The ability to perform a simple blood test in a clinical setting, without the need for hospitalization or specialized equipment, could dramatically change patients' prospects.

New hopes and challenges

Experts emphasize that with new diagnostics come challenges, including the need to develop clear guidelines for interpreting results and training medical personnel. It will also be important to educate patients and their families to understand the importance of early diagnosis and possible treatment paths.

In parallel, registration procedures for similar diagnostic tests are underway in Europe and Japan. The Japanese branch of Fujirebio has already implemented similar studies on its market, and the European Medicines Agency (EMA) is analyzing the potential for their implementation within the EU health system.

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