The U.S. Food and Drug Administration approved the Lumipulse® blood test in May 2025, marking the first time a blood biomarker test can be used to aid in the diagnosis of Alzheimer’s disease. The test measures levels of the protein pTau217 and the ratio of ß-Amyloid 1-42 in a blood sample to detect the presence of amyloid plaques and tau tangles, key indicators of the disease.
Previously, confirming an Alzheimer’s diagnosis required costly and often invasive procedures like PET scans or lumbar punctures, which analyze brain imaging or cerebrospinal fluid, respectively. The Lumipulse test offers a simpler, less invasive, and more accessible alternative, according to Dr. Michal Schnaider Beeri, Director of the Herbert and Jacqueline Krieger Klein Alzheimer’s Research Center at Rutgers University’s Brain Health Institute. “This blood test offers a simpler, less invasive, and more widely accessible way to support early and accurate detection of amyloid plaques and tau tangles,” she stated.
Clinical studies demonstrated the test’s accuracy, with 91.7% of individuals who tested positive for Alzheimer’s biomarkers via the Lumipulse test subsequently confirmed to have amyloid plaques through PET scans or cerebrospinal fluid analysis. The FDA approval is intended for leverage in individuals aged 55 or older who are experiencing cognitive symptoms. The test is not intended as a standalone diagnostic tool, but rather as part of a comprehensive evaluation that includes medical history, physical examination, and potentially brain imaging.
Alongside the Lumipulse test, research is progressing on utilizing artificial intelligence (AI) to predict the progression of dementia. A new AI model can now forecast the course of dementia using routine data gathered from primary care physicians, analyzing demographic information and simple memory test results. This development, alongside the blood test measuring p-tau217, represents a significant step towards earlier and more accessible diagnosis.
The p-tau217 protein measured by the blood test is also being studied for its potential to estimate the timeframe for the onset of clinical symptoms. Whereas not yet a precise predictor for individual patients, this capability holds promise for research and the planning of clinical trials. The Mayo Clinic notes that results from the Lumipulse test are typically available within two to five days.
The European Research Academy on Alzheimer’s Disease (ERA-AD) recently held an expert workshop to discuss these latest findings and their implications for the future of Alzheimer’s diagnosis and treatment. The combination of AI-driven prediction and blood-based biomarker detection is expected to significantly accelerate research efforts and improve patient care.