First Blood Test for Alzheimer’s Approved in the US
The United States has recently given the green light to the first blood test for Alzheimer’s disease. This groundbreaking approval could revolutionize the way patients are diagnosed and treated for this debilitating neurological condition.
The test, developed by Fujirebio Diagnostics, measures the ratio of two proteins in the blood that are correlated with amyloid plaques in the brain – a key indicator of Alzheimer’s disease. Previously, detecting these plaques required expensive brain scans or invasive spinal fluid analysis.
According to Food and Drug Administration Commissioner Marty Makary, “Alzheimer’s disease affects more people than breast cancer and prostate cancer combined. With the aging population, the number of individuals with Alzheimer’s is expected to double by 2050. The approval of this blood test is a crucial step in improving the diagnosis and treatment of this devastating disease.”
Currently, there are two FDA-approved treatments for Alzheimer’s – lecanemab and donanemab. These drugs target amyloid plaque in the brain and have been shown to slow cognitive decline, although they do not provide a cure.
Advocates for intravenous antibody therapies believe that starting treatment early in the disease’s progression can offer patients a few extra months of independence. The newly approved blood test could help identify individuals who would benefit most from these treatments.
Clinical studies have shown that the blood test produces results comparable to PET brain scans and spinal fluid analysis. This non-invasive method only requires a simple blood draw, making it more accessible to patients.
Michelle Tarver from the FDA’s Center for Devices and Radiological Health commented, “Today’s clearance of the Alzheimer’s blood test is a significant advancement in early diagnosis and management of the disease. It will make it easier for patients in the US to receive timely and accurate diagnoses.”
The test is authorized for use in clinical settings for patients exhibiting cognitive decline, and results must be interpreted in conjunction with other clinical information. Alzheimer’s disease, the most common form of dementia, progressively impairs memory and independence over time.
© Agence France-Presse
