FDA Clears First Blood Test for Alzheimer's
The Lumipulse test targets patients 55 and older, offering an alternative to invasive brain scans and spinal fluid procedures.
By Marco Ortega ·
The Food and Drug Administration cleared the Lumipulse in May 2025, marking the first time the agency approved a blood test to aid in the diagnosis of Alzheimer’s disease. The test detects amyloid plaque in the brain, a primary biological marker of the condition. Previously, doctors relied on brain scans or spinal fluid samples to identify these markers, procedures that are more invasive than a simple blood draw.
Dr. Rhea Rogers, a board-certified physician and host of Aging Untold, described the approval as a major shift for patients over 55 experiencing cognitive decline. The test is specifically indicated for this demographic. Rogers noted that the availability of a less invasive option could encourage earlier evaluation. She stated that catching the disease sooner allows for better planning and improved quality of life.
Researchers indicate that a positive result from the Lumipulse test correlates with a greater than 90% probability that amyloid plaque is present in the brain. However, the FDA emphasized that the test is not a standalone diagnostic tool. It is intended for patients already experiencing memory problems. Medical professionals must interpret the results alongside the patient's medical history and other assessments, such as cognitive testing.
Kathi Rigby was diagnosed with Alzheimer’s disease in 2022 after a familiar bike ride with her husband turned frightening when she struggled to find her words. She described the diagnosis as a shock. For Rigby, the earlier detection of the disease allowed her to participate in a clinical trial for a drug designed to remove brain plaque. Her husband, Brent, reported that 95% of the plaque was removed during the trial.
Rigby said the treatment made a difference in her ability to communicate. She expressed a desire to remain present for her family, stating that she wants to be a grandmother who knows and loves her grandchildren. Her individual response to the drug does not predict how the treatment will affect other patients. The FDA clearance of the blood test aims to provide a clearer pathway for patients to access such interventions.
The Lumipulse test is now available for use in clinical settings. Doctors can order the test for patients aged 55 and older who present with symptoms of cognitive decline. The approval adds a new tool to the diagnostic process, potentially reducing the need for more complex procedures in the initial stages of evaluation.
