In a crucial advancement for Alzheimer’s disease diagnosis, the U.S. Food and Drug Administration (FDA) granted clearance for an Alzheimer’s disease blood test on May 16, 2025. The test is an in vitro diagnostic (IVD) assay capable of detecting amyloid — a key protein involved in Alzheimer’s disease — in blood. Data samples used to evaluate the validity of the test are from research conducted at the University of Wisconsin–Madison.
The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms.
The Wisconsin Alzheimer’s Disease Research Center (ADRC) and the Wisconsin Registry for Alzheimer’s Prevention (WRAP) provided 40% of the samples used in the validation study to evaluate the plasma p-tau217/Aβ42 ratio as a reliable biomarker of amyloid pathology in the brain. At the UW–Madison Alzheimer’s disease programs’ biofluids laboratory, these biomarker levels were measured in cerebrospinal fluid (CSF); and then demonstrated that levels of these proteins were congruent in blood plasma samples from the same individuals.
Read the full story: https://wai.wisc.edu/2025/05/28/uw-madison-research-helps-launch-first-fda-cleared-blood-test-for-alzheimers-disease/