Related Experiment Video
Updated: Mar 14, 2026
Cell-Free DNA Integrity Analysis in Urine Samples
Published on: January 5, 2017
Clinical performance of ASCL1/LHX8 DNA methylation on first-void urine to screen for cervical cancer
Severien Van Keer1, Rianne van den Helder2,3, Laura Téblick4
1Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Edegem, Belgium. severien.vankeer@uantwerpen.be.
Background:
DNA methylation analysis provides a promising triage strategy for cervical intraepithelial neoplasia (CIN) and cancer detection following Human Papillomavirus (HPV) testing on self-collected samples, including urine.
Methods:
This study aimed to develop an entirely molecular cervical screening approach based on HPV and DNA methylation analysis in at-home collected first-void urine from healthy females (n = 69) and a referral population (n = 385; CIN-cancer). CIN3+ detection was analyzed by multivariate logistic regression.
Results:
Here we show that urinary ASCL1/LHX8 methylation levels increase significantly in relation to disease severity, with AUC-values for CIN3+ of 0.81 (95% CI: 0.74-0.88) and 0.83 (95% CI: 0.74-0.92) in the training (n = 285) and validation cohort (n = 160), respectively. This corresponds to a validated CIN3+ sensitivity of 73.0% (95% CI: 57.0-84.6%) at 81.9% specificity (95% CI: 73.5-88.1%;
Conclusions:
The ASCL1/LHX8 methylation test detects nearly all cancers and a majority of CIN3 in first-void urine, supporting the potential of full molecular screening in urine by primary HPV testing and methylation triage.
