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 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.
“This is spectacular news and a breakthrough in identifying reliable blood biomarkers for Alzheimer’s disease,” said Sanjay Asthana, MD, founding director of the Wisconsin ADRC. “Our ADRC and WRAP programs were instrumental in this achievement, underscoring the strength and vision of our biomarker research initiatives.”
Sterling Johnson, PhD, principal investigator of the WRAP study, said the FDA approval will have clinical and wide significance. “This milestone transforms years of patient-centered research into a tool physicians can now use to benefit their patients and guide care,” he said. “As one of the early leaders in Alzheimer’s biomarker research, the UW Alzheimer’s program is at the forefront of this progress.”
In 2024, UW–Madison researchers established an expanded biomarker and biofluids lab with advanced testing and diagnostic technology, including installing a Lumipulse instrument. Rachael Wilson, PhD, oversees the installation and use of the Lumipulse and the biofluids lab along with program manager Beckie Jeffers.
The availability of samples and the flexibility and success are largely thanks to the dedicated research participants at the Wisconsin ADRC and WRAP, and Johnson said he attributes this success to their contributions, in addition to the skilled nurse practitioners who conduct lumbar puncture procedures. “We have had an incredible partnership with the Clinical Research Unit, which has enabled skilled CSF and blood collection for all these years,” he said.
A current focus of the program is to continue to support biomarker tools for detection, and continued utilization of CSF will be key to validating tests for other neurodegenerative diseases, including Lewy body dementia (LBD), Parkinson’s disease, Limbic-predominant age-related TDP-43 encephalopathy (LATE), frontotemporal dementia and Amyotrophic Lateral Sclerosis (ALS).
-By Claire Bitner
Updated 5/28/2025
