In a landmark decision, U.S. health officials on Friday approved the first blood test designed to aid in the diagnosis of Alzheimer’s disease, potentially transforming the way the memory-destroying illness is detected and treated.How the New Blood Test WorksThe newly approved test, developed by Fujirebio Diagnostics, Inc., is designed for patients aged 55 and older who are experiencing early symptoms of cognitive decline, such as forgetfulness or confusion. The test detects the presence of beta-amyloid, a sticky protein that builds up into plaques in the brain—a hallmark of Alzheimer’s disease.Until now, confirming the presence of amyloid plaques has required invasive spinal taps or expensive PET scans, both of which are limited in availability. This blood test offers a far more accessible and less invasive option.What Is Alzheimer's?Alzheimer’s disease is a progressive brain disorder that slowly destroys memory, thinking skills, and the ability to carry out even simple tasks. It is the most common cause of dementia, accounting for 60–70% of dementia cases worldwide, according to the World Health Organization (WHO).As described by the Centers for Disease Control and Prevention (CDC), Alzheimer’s is not a normal part of aging, although the greatest known risk factor is advancing age. The condition begins with mild memory loss and can lead to loss of the ability to carry on a conversation and respond to the environment. Changes in the brain often begin years before symptoms appear.More than 6 million Americans live with Alzheimer’s, and the number is expected to rise significantly as the population ages. Worldwide, the disease affects an estimated 55 million people with dementia, according to WHO figures.Expanding Access to New TreatmentsThe test’s approval is also expected to broaden the use of recently approved Alzheimer’s drugs such as Leqembi (lecanemab) and Kisunla (donanemab). These drugs work by targeting and helping to clear beta-amyloid plaques from the brain. However, before treatment can begin, doctors must confirm amyloid buildup.With the new test, that confirmation could come from a simple blood draw rather than more complex procedures. According to Dr. Michelle Tarver, deputy director of the FDA’s Center for Devices and Radiological Health, “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”Only for Symptomatic PatientsIt’s important to note that the test is not designed for widespread screening or for people who don’t yet show symptoms. It must be ordered by a physician and used in conjunction with other clinical evaluations. The goal is to support doctors in distinguishing Alzheimer’s from other conditions that can cause memory loss or cognitive problems, such as vitamin deficiencies, depression, or stroke.Concerns Over Unregulated TestsFor several years, some specialized labs have offered their own amyloid tests without FDA oversight. These tests varied in quality and were typically not covered by insurance, leading to a confusing and unregulated marketplace that some experts have described as a “wild west” of Alzheimer’s diagnostics.The new approval offers a validated option that doctors and patients can trust, paving the way for more standardized care and insurance coverage.