FDA clears blood test to detect brain plaque in Alzheimer’s patients
The Lumipulse test, approved in May 2025, offers a less invasive diagnostic option for adults 55 and older experiencing cognitive decline.
By Layla Richardson ·
Diagnosing Alzheimer’s disease has traditionally required brain scans or spinal fluid tests, procedures that many patients find invasive. The Food and Drug Administration changed that standard in May 2025 when it cleared the Lumipulse, the first blood test authorized to aid in diagnosing the condition.
The Lumipulse detects amyloid plaque, a key biological marker of Alzheimer’s disease, directly from a patient’s blood. The agency restricted the approval to patients aged 55 and older who are already displaying symptoms of memory problems. It is not a standalone diagnostic tool. Doctors must interpret the results alongside a patient’s medical history and other clinical assessments, such as cognitive testing.
Researchers indicate that a positive result on the Lumipulse correlates with a greater than 90% probability that amyloid plaque is present in the brain. This high correlation aims to streamline the diagnostic process for individuals already showing signs of cognitive decline.
Kathi Rigby, who was diagnosed with Alzheimer’s in 2022, described the initial realization of her symptoms as a moment when she could not get words from her brain to her mouth. The diagnosis itself felt like a slap in the face. Her case illustrates the practical impact of earlier detection. Rigby was able to enter a clinical trial for a drug designed to remove brain plaque shortly after her diagnosis.
Her husband, Brent Rigby, reported that the treatment removed 95% of the plaque in her brain. While individual outcomes vary, Rigby said the treatment improved her quality of life. She expressed a desire to remain engaged with her family, stating, “I want to be Grandma, and I want them to know that I love them, and I know them.”
Dr. Rhea Rogers, a board-certified physician and host of the program Aging Untold, noted that the blood test is particularly useful for those 55 and older with cognitive symptoms. She emphasized that identifying the disease earlier allows patients and families to plan care options and potentially improve quality of life.
The FDA clearance marks a shift toward less invasive screening methods for a disease that affects millions of Americans. The Lumipulse provides a specific biological data point that clinicians can use to confirm suspicions raised by standard memory tests.
