FDA clears first blood test for Alzheimer's diagnosis in patients 55 and older
The Lumipulse test detects amyloid plaque with over 90% accuracy, offering a less invasive alternative to brain scans and spinal fluid tests.
By Ella Cox ·
For adults aged 55 and older who are experiencing memory problems, a new blood test offers a less invasive option for evaluating Alzheimer’s disease. The Food and Drug Administration cleared the Lumipulse in May 2025. It is the first blood test authorized by the agency to assist in diagnosing the condition. Previously, doctors often relied on brain scans or spinal fluid tests to detect the disease.
The test looks for amyloid plaque, a key marker of Alzheimer’s. Researchers indicate that if a patient tests positive, there is a greater than 90% chance they have amyloid plaque in their brain. Dr. Rhea Rogers, a board-certified physician and host of the program Aging Untold, noted that the test is indicated for people 55 years of age or greater with symptoms of cognitive decline. She described the tool as a game changer for this specific demographic.
The FDA cautions that the blood test is not a standalone diagnostic tool. Doctors must interpret the results alongside a patient’s medical history and other assessments, such as cognitive testing. This approach ensures that the diagnosis accounts for the full clinical picture rather than relying on a single data point.
Early identification allows patients and families to plan for care and consider treatment options sooner. Dr. Rogers stated that catching the disease earlier can make a greater impact on quality of life. For Kathi Rigby, who was diagnosed with Alzheimer’s in 2022, early detection enabled her to join a clinical trial for a drug designed to remove brain plaque. Her husband, Brent, said that 95% of the plaque was removed in her case. While her individual response does not guarantee the same outcome for others, Rigby said the treatment made a difference in her ability to connect with her family.
Rigby described the diagnostic process and the subsequent treatment as critical for maintaining her relationship with her grandchildren. She said she wants to be recognized by them and to express her love clearly. The availability of the Lumipulse test provides a new pathway for patients like Rigby to seek evaluation without the immediate need for more invasive procedures.
The test is currently available for use in the specific population defined by the FDA. It serves as an additional tool in the diagnostic process for those showing signs of cognitive decline. Doctors will continue to use standard medical history and cognitive testing alongside the blood results to reach a final diagnosis.
