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FDA Gives Marketing Nod to Blood Test for Diagnosing Alzheimer Disease

Medically reviewed by Carmen Pope, BPharm. Last updated on May 18, 2025.

By Stephanie Brown HealthDay Reporter

FRIDAY, May 16, 2025 -- The first in vitro diagnostic device that uses blood samples to detect Alzheimer disease has been granted marketing clearance by the U.S. Food and Drug Administration.

The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is approved for the early detection of amyloid plaques associated with Alzheimer disease in patients aged 55 years and older who are showing signs of the disease.

"The ability to diagnose Alzheimer's earlier with a simple blood test, like we do for cholesterol, is a game changer, allowing more patients to receive treatment options that have the potential to significantly slow or even prevent the disease," Howard Fillit, M.D., cofounder and chief science officer of the Alzheimer's Drug Discovery Foundation, said in a statement. "This is a clear example of the new era of Alzheimer's research where innovation, science, and technology come together to develop more accessible, affordable, and scalable tools that will pave the way for additional regulatory approvals of diagnostic tools."

The Lumipulse test measures the two serum proteins pTau217 and β-amyloid 1-42. Using these measurements, the numerical ratio of the levels of the two proteins is calculated and "correlated to the presence or absence of amyloid plaques in the patient's brain."

The Lumipulse test reduces the need for positron emission tomography (PET) and the need to collect cerebrospinal fluid (CSF) via invasive lumbar puncture, which is required by previously approved tests. The Lumipulse test simply requires a blood sample.

The approval of the Lumipulse test was based on data from a multicenter clinical study of 499 individual plasma samples collected from adults identified as cognitively impaired. According to the study results, 91.7 percent of Lumipulse-positive individuals and 97.3 percent of Lumipulse-negative individuals had the presence and absence, respectively, of amyloid plaques by PET scan or CSF test result. Less than 20 percent of test results were indeterminate.

The FDA notes that the test is designed for patients in specialized care settings who exhibit signs and symptoms of cognitive decline, and results should always be interpreted alongside other relevant clinical information.

“Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million,” Michelle Tarver, M.D., Ph.D., director of the FDA Center for Devices and Radiological Health, said in a statement. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”

Marketing clearance for the Lumipulse was granted to Fujirebio Diagnostics.

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Posted May 2025

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