FDA clears first blood test for Alzheimer's screening
The new test detects brain plaque in patients over 55 and aims to replace invasive scans for early diagnosis.
By Leila Reynolds ·
The Food and Drug Administration cleared the Lumipulse in May 2025. This approval marks the first time the agency has authorized a blood test to help diagnose Alzheimer's disease.
The test detects amyloid plaque, a key marker of the condition. Researchers state that a positive result indicates a greater than 90% probability that amyloid plaque is present in the brain.
Dr. Rhea Rogers, a board-certified physician and host of the show Aging Untold, described the tool as useful for specific patients. She noted it is indicated for people 55 years of age or older who show symptoms of cognitive decline.
The FDA specified that the test is for patients already experiencing memory problems. The agency cautioned 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.
Kathi Rigby received an Alzheimer's diagnosis in 2022. She described the moment she learned the news as feeling like a slap in the face. Rigby had previously struggled to communicate during a bike ride with her husband, Brent.
"I couldn't get words from my brain to my mouth," Rigby said. Early detection allowed her to join a clinical trial for a drug intended to remove brain plaque. Her husband reported that 95% of the plaque was removed in her case.
Rogers said identifying the disease earlier helps families plan for care. She argued that catching the condition sooner allows for a greater impact on quality of life. Rigby said the treatment helped her maintain her role as a grandmother. "I want them to know that I love them, and I know them," she said.
