U.S. Approves Groundbreaking Blood Test for Alzheimer’s Diagnosis
WASHINGTON — In a significant move for Alzheimer’s research and treatment, U.S. health officials have approved the first blood test that can help diagnose Alzheimer’s disease. This innovative test will assist in identifying patients who may benefit from treatments that can slow the progress of the memory-depleting illness.
The blood test allows doctors to determine whether a patient’s memory issues stem from Alzheimer’s or other medical conditions affecting cognitive function. The Food and Drug Administration (FDA) has made this test available for patients aged 55 and older who exhibit early signs of the disease.
Alzheimer’s is a pressing concern, with over 6 million individuals in the United States alone affected by this prevalent form of dementia. The test, developed by Fujirebio Diagnostics, Inc., detects beta-amyloid, a sticky brain plaque that serves as a critical marker for Alzheimer’s. Previously, the only FDA-recognized methods for identifying amyloid involved more invasive spinal fluid tests or costly PET scans.
This new blood test is expected to make screening more affordable and accessible, potentially increasing the use of two emerging drugs, Leqembi and Kisunla. These medications have shown promise in slightly slowing Alzheimer’s progression by clearing amyloid from the brain. Before doctors can prescribe these drugs, patients must be tested for the amyloid plaque, which requires regular intravenous infusions.
Dr. Michelle Tarver, from the FDA’s center for devices, emphasized the importance of this development: “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and more accessible for U.S. patients earlier in the disease.”
While several specialty hospitals and laboratories had already created their own tests for amyloid in recent years, those tests were not FDA-reviewed and often not covered by insurance. This led to confusion and inconsistency in testing options, as doctors grappled with assessing which tests were truly reliable. Several larger companies, such as Roche and Eli Lilly, are also working on their own versions of tests for FDA approval.
It’s crucial to note that the approved test can only be ordered by a doctor and is not intended for individuals showing no symptoms of the disease. This step forward marks a hopeful moment for those affected by Alzheimer’s, providing a clearer pathway to diagnosis and treatment.
