Methylation testing versus cervical cytology for triage of HPV-positive women: A comparative study.

Background: In many countries, HPV testing has replaced cervical cytology as the primary screening method for cervical cancer. While HPV testing has high sensitivity, its limited specificity necessitates triage to reduce unnecessary colposcopy referrals. This study evaluates the performance of cervical cytology (TCT) and the GynTect® six-gene methylation test as triage methods for HPV-positive women.

Methods: A total of 276 women from China were categorized into four pathological groups: cervical squamous cell carcinoma (CSCC), CIN3, CIN2, and CIN1. The diagnostic performance of TCT and the GynTect test was assessed for detecting CIN3+, with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) calculated for both methods.

Results: Abnormal cytology (ASC-US+) had a sensitivity of 71.9% and specificity of 75.0% for detecting CIN3+, with a PPV of 57.5% and NPV of 85.0%. In comparison, the GynTect test demonstrated superior diagnostic accuracy, with a sensitivity of 88.5%, specificity of 87.2%, PPV of 78.7%, and NPV of 93.5%. The GynTect test outperformed cytology in identifying CIN3+ while reducing unnecessary colposcopies in women with CIN2- lesions.

Conclusions: The GynTect six-gene methylation test provides higher diagnostic accuracy than cervical cytology in the triage of HPV-positive women. Its superior sensitivity and specificity make it a valuable tool for improving risk stratification in HPV-based cervical cancer screening. These findings support the integration of methylation-based testing into screening programs to enhance diagnostic precision and optimize patient management.