2025-05-19T01:52:35Z

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In a significant advancement for Alzheimer’s disease diagnosis, the United States Food and Drug Administration (FDA) approved the first-ever blood test specifically designed to detect this debilitating neurological disorder on Friday. This groundbreaking development could enable patients to initiate treatment sooner, particularly with the newly approved drugs that are known to slow the progression of Alzheimer's.

The blood test, developed by Fujirebio Diagnostics, assesses the levels of two specific proteins in the bloodstream. The ratio of these proteins has been identified as closely correlated with the presence of amyloid plaques in the brain—plaques that are a defining characteristic of Alzheimer's disease. Up until this point, the detection of these plaques required invasive procedures such as brain scans or analysis of spinal fluid, making this new test a significant leap forward in terms of patient comfort and accessibility.

FDA Commissioner Dr. Marty Makary emphasized the urgency of addressing the Alzheimer's crisis, stating, "Alzheimer's disease impacts too many people – more than breast cancer and prostate cancer combined." He highlighted the alarming statistic that approximately 10% of individuals aged 65 and older are currently affected by Alzheimer's, and projections indicate that this figure could double by the year 2050. Dr. Makary expressed hope that medical innovations like this blood test will significantly assist patients and their families.

Currently, there are two FDA-approved treatments for Alzheimer's: lecanemab and donanemab. These drugs specifically target amyloid plaques and have demonstrated the ability to modestly slow cognitive decline. However, it is crucial to note that they do not provide a cure for the disease. Advocates for these intravenous antibody treatments, including many leading neurologists, argue that these therapies can offer patients several extra months of independence, especially when administered early in the disease's progression.

The blood test has shown promising results in clinical studies, aligning closely with the outcomes of positron emission tomography (PET) brain scans and spinal fluid analysis. According to Michelle Tarver from the FDA's Center for Devices and Radiological Health, "Today's clearance is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for US patients earlier in the disease." The test is approved for use within clinical settings for patients exhibiting signs of cognitive decline, with results needing to be interpreted alongside other clinical data.

Alzheimer’s disease, recognized as the most prevalent form of dementia, progressively deteriorates an individual’s cognitive abilities, ultimately robbing them of their memories and independence. This new testing method may offer a beacon of hope for early detection and intervention.

© Agence France-Presse