FDA Clears First Alzheimer's Blood Test
The Lumipulse assay detects amyloid plaque in patients 55 and older, potentially reducing reliance on spinal fluid tests.
By Fatou Kim ·
The Food and Drug Administration cleared the first blood test designed to aid in the diagnosis of Alzheimer's disease in May 2025.
The test, known as Lumipulse, detects amyloid plaque in the brain, a key biological marker of the condition. Researchers indicate that a positive result correlates with a greater than 90% probability that a patient has amyloid plaque in their brain. The agency restricted its use to individuals aged 55 and older who are already exhibiting memory problems. It is not intended as a standalone diagnostic tool. Clinicians must interpret the results alongside a patient's medical history and other assessments, such as cognitive testing.
Dr. Rhea Rogers, a board-certified physician and host of the television program Aging Untold, described the development as a game changer. She noted that the test is indicated for people 55 years of age or greater who show symptoms of cognitive decline. Previously, diagnosing the disease often required brain scans or tests of spinal fluid. Rogers said that identifying the condition earlier allows people and their families to plan for care options. She stated that catching the disease early can make an impact on quality of life.
Kathi Rigby was diagnosed with Alzheimer's disease in 2022. She recalled a bike ride with her husband where she suddenly struggled to communicate. Rigby said, “I couldn’t get words from my brain to my mouth.” She described the diagnosis as “like a slap in the face.” Her early detection allowed her to participate in a clinical trial for a drug intended to remove brain plaque. Her husband, Brent, reported that 95% of the plaque was removed. While her specific outcome does not indicate how the treatment will work for other patients, Rigby said the therapy made a difference for her. She said, “I want to be Grandma, and I want them to know that I love them, and I know them.”
The Lumipulse test offers a less invasive alternative to current diagnostic procedures. The FDA maintains that the blood test should complement existing medical evaluations rather than replace them. Patients seeking personal medical advice are advised to consult a licensed physician regarding their specific condition.
