FDA Approves First Blood-Based Diagnostic Test for Alzheimer’s Disease

The U.S. Food and Drug Administration has approved the first blood-based diagnostic test to support the evaluation of Alzheimer’s disease. The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test measures levels of two key proteins in plasma—pTau217 and β-amyloid 1-42—calculating their ratio to indicate the likely presence of amyloid plaques in the brain, a hallmark of Alzheimer’s.

Intended for patients aged 55 and older with signs of cognitive decline, the test offers a less invasive alternative to traditional methods such as amyloid PET scans or cerebrospinal fluid analysis via lumbar puncture. While PET imaging remains a widely used diagnostic tool, it is costly, time-consuming, and exposes patients to radiation. The Lumipulse test only requires a blood draw, making it more accessible for routine clinical use.

“Alzheimer’s disease affects more Americans than breast and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “With prevalence expected to double by 2050, tools like this can support earlier diagnosis and better patient care.”

Alzheimer’s is a progressive neurodegenerative disease that gradually impairs memory, thinking, and daily function. Detecting amyloid pathology early can help guide treatment decisions, clinical trial eligibility, and care planning. The approval of this test marks a significant step toward simplifying and broadening access to Alzheimer’s diagnostics.

SOURCE: https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease 

CREDITS: U.S. FOOD AND DRUG ADMINISTRATION