By Diagnostics World Staff
July 17, 2025 | A study has revealed that phosphorylated tau (p-tau217), a key biomarker for Alzheimer's disease diagnosis, appears at even higher levels in healthy newborns than in adults with Alzheimer's disease—a finding that could reshape how clinicians interpret this widely-used diagnostic tool.
The study, led by Fernando Gonzalez-Ortiz, M.D. Ph.D. at the University of Gothenburg and Sahlgrenska University Hospital and published in Brain Communications, analyzed plasma samples from over 400 individuals across age groups, including healthy newborns, premature infants, Alzheimer's patients, and healthy controls. Researchers measured five biomarkers, with only tau forms showing extreme increases in newborns compared to other age groups.
The research demonstrated that p-tau217 levels in newborns were significantly higher than those found in Alzheimer's patients, with levels inversely correlating with gestational age. This challenges the current understanding of what constitutes "normal" or "pathological" levels of this biomarker. The findings suggest that elevated p-tau217 readings don't automatically indicate disease pathology and emphasize the need for proper clinical context when interpreting biomarker results. As Gonzalez-Ortiz noted, biomarkers "should only guide our clinical evaluations, not replace it."
The research opens possibilities for using p-tau217 as an objective measurement tool for assessing newborn brain maturity, potentially providing more clinically meaningful information than current assessment scales.
Future Diagnostic Development
Gonzalez-Ortiz plans to compare plasma samples from healthy babies and those that were followed for 20 years because of problems at birth to determine how p-tau217 levels at birth predict future developmental changes. The team is also working to develop assays that can distinguish between fetal and adult tau isoforms, which could provide more precise diagnostic information.
This research underscores the importance of understanding biomarkers within their physiological context and could lead to more nuanced diagnostic approaches for both neurodevelopmental assessment and Alzheimer's disease.
Read Deborah Borfitz’s full story on Bio-IT World for more details about this research and its implications for biomarker interpretation in clinical practice.