Performance of a six-methylation-marker assay in predicting LEEP specimen histology results of cervical HSIL patients: a retrospective study.

Background: Discrepancies have been found between preoperative colposcopic biopsy results and histology results of loop electrical excision procedure (LEEP) specimens. GynTect^® is a six-methylation-marker assay that has demonstrated its potential as a triage tool for cervical lesion detection and prediction. The aim of this study was to evaluate the effectiveness of GynTect^® in predicting the histology outcomes of post-LEEP specimens.

Method: A retrospective analysis was conducted to evaluate the clinical profiles, GynTect^® results, and histology outcomes of postoperative specimens from 78 patients diagnosed with high-grade squamous intraepithelial lesion (HSIL) who underwent LEEP. The GynTect^® assay is a six-marker (ASTN1, DLX1, ITGA4, RXFP3, SOX17, and ZNF671) methylation detection assay for cervical prep cell samples. Preoperative cervical cytology, high-risk human papillomavirus (hrHPV) detection, and methylation analysis were obtained from each participant. Preoperative colposcopic impression and biopsy results were recorded. Statistical analysis and multivariate logistic regression were performed using IBM SPSS Statistics 25.

Results: Among the negative-GynTect^® patients, 19 cases (57.6%) showed histology downgrading post-LEEP, while 14 cases (42.4%) showed sustained or upgrading histology results. In the positive-GynTect^® patients, 8 cases (17.8%) showed downgrading histology results post-LEEP and 37 cases (82.2%) showed sustained or upgrading histology. The difference was statistically significant (p = 0.001). Multivariate regression analysis identified positive GynTect^® outcomes and colposcopic impressions indicating HSIL on the day of surgery as independent predictors of pathological sustained or upgrading after LEEP.

Conclusions: This study underscores the potential of GynTect^® in predicting histology outcomes of post-LEEP specimens, thereby showcasing its promising ability to assist clinicians in selecting appropriate therapeutic regimens for patients with HSIL.