FDA

FDA greenlights first blood test to aid Alzheimer’s diagnosis

May 20, 2025

FDA has cleared the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, the first blood-based diagnostic test for Alzheimer’s disease. Designed for adults aged 55 and older with cognitive symptoms, the test measures plasma levels of two key biomarkers—pTau217 and β-amyloid 1-42—to estimate the presence of amyloid plaques, a hallmark of Alzheimer’s. In a pivotal study of 499 cognitively impaired adults, the test demonstrated strong concordance with PET imaging and cerebrospinal fluid (CSF) results: 91.7% of those with positive blood test results also had amyloid plaques confirmed by imaging or CSF, while 97.3% of those with negative results were similarly confirmed negative. Fewer than 20% of patients received indeterminate results. This approval marks a major shift from invasive diagnostics, offering a faster, safer, and more scalable option—especially valuable in primary care settings. With Alzheimer’s prevalence expected to nearly double by 2050, this test could significantly enhance early detection and treatment planning.

Source:

(2025, May 16). FDA. FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease. https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease