FDA Clears Blood Test for Alzheimer's in Patients Over 55
The Lumipulse test detects amyloid plaque with high accuracy, offering an alternative to spinal fluid samples and brain scans.
By Aiko Petrov ·
Diagnosing Alzheimer's disease has traditionally required invasive procedures, such as spinal fluid analysis or brain imaging. A new blood test approved by the Food and Drug Administration offers a less invasive method for detecting a key biological marker of the condition. The agency cleared the Lumipulse test in May 2025, marking the first time a blood test has received this specific clearance.
The test measures amyloid plaque in the brain. Researchers indicate that a positive result carries a greater than 90% probability that the patient has amyloid plaque. Dr. Rhea Rogers, a board-certified physician and host of the program Aging Untold, described the development as a major shift for patients aged 55 and older who exhibit symptoms of cognitive decline.
The FDA restricts the use of the Lumipulse to patients 55 years of age and older who are already experiencing memory problems. The agency specified that the test is not a standalone diagnostic tool for Alzheimer's disease. Clinicians must interpret the results alongside a patient's medical history and other evaluations, including standard cognitive testing.
Kathi Rigby, diagnosed with Alzheimer's in 2022, experienced a sudden difficulty communicating during a routine bike ride with her husband. She described the diagnosis as a shock. Early detection allowed her to participate in a clinical trial for a drug designed to remove brain plaque. Her husband, Brent, stated that 95% of the plaque was removed in her case.
Dr. Rogers noted that identifying the disease earlier allows families to plan care and consider treatment options. She explained that catching the disease at an early stage can improve quality of life. Rigby said the treatment she received in the trial made a difference, enabling her to maintain her role as a grandmother.
The Lumipulse test is now available for use in eligible patients. While the test aids in the diagnostic process by identifying the presence of amyloid plaque, it does not confirm a final diagnosis of Alzheimer's disease on its own.
