Breakthrough CISCER Methylation Testing Aids Early Cervical Cancer Screening
Recently, a cervical cancer methylation study from Peking Union Medical College Hospital was published in the renowned oncology journal British Journal of Cancer, confirming that combined PAX1 and JAM3 gene methylation testing (CISCER®) performs excellently in early cervical cancer screening. Particularly among non-HPV 16/18 high-risk populations, CISCER® can more accurately identify high-grade precancerous lesions while substantially reducing unnecessary colposcopy examinations. The CISCER® methylation kit, as a domestically developed Class III medical device approved by the NMPA, provides a powerful non-invasive molecular tool for precision cervical cancer prevention and control.
Study Background | What Challenges Does Cervical Cancer Screening Face?
The primary cause of cervical cancer is persistent infection with high-risk HPV, especially HPV 16/18. Currently, there has been limited systematic research on screening and triage management for populations infected with non-16/18 types (such as HPV 31, 33, 35). Traditional liquid-based cytology (LBC) is subject to significant subjective variability and poor reproducibility, coupled with persistently high colposcopy referral rates, easily leading to medical resource waste and particularly difficult to implement in resource-limited areas. How to achieve precise triage and avoid overscreening? Molecular testing has become the new direction.
Study Methods | CISCER® Methylation Kit vs. Traditional Testing "Head to Head"
The study was based on two multicenter prospective studies, METHY3 and METHY4, led by Peking Union Medical College Hospital, enrolling 1,307 women with non-16/18 high-risk HPV infection. Participants underwent HPV genotyping, LBC, and CISCER® methylation testing, with final lesion grade confirmed by pathological diagnosis. The study systematically compared the three methods' performance in CIN2+ and CIN3+ lesion screening, evaluating sensitivity, specificity, colposcopy referral rates, and positive predictive value, with multivariate regression analysis for independent predictors.
Study Results | CISCER® Methylation Testing Is Accurate and Efficient
The CISCER® methylation kit performed best in CIN3+ risk prediction, with a risk of 39.3% for positive cases versus only 0.9% for negative cases, achieving an AUC of 0.892. In contrast, LBC-positive risk was only 9.8%, yet its referral rate was as high as 61.9%. CISCER®'s positive referral rate was only 17.4%, significantly reducing overscreening risk. CISCER® was the only factor with significant independent predictive value for CIN3+ (OR = 68.07). When combined with HPV 33/35 genotyping, CIN3+ risk increased to 50%, significantly improving screening efficiency, particularly suitable for primary care areas with insufficient cytology resources.
Study Results | CISCER® Methylation Testing Is Accurate and Efficient
With its automated and standardized advantages, CISCER® methylation testing is particularly suitable for regions with limited pathology resources. Combined with HPV genotyping, CISCER®-negative cases, after comprehensive physician assessment, may potentially return directly to routine screening without frequent retesting or invasive examinations and overtreatment. Looking ahead, we expect CISCER® methylation testing to be incorporated into national screening workflows as the standard triage tool for women with non-16/18 high-risk HPV infection, helping to achieve the WHO goal of "eliminating cervical cancer" and adding "molecular-level" protection for women's health.
Reference
Su, H., Jin, X., Kong, L. et al. The triage role of cytological DNA methylation in women with non-16/18, specifically genotyping high-risk HPV infection. Br J Cancer (2025). https://doi.org/10.1038/s41416-025-03005-5.
Article Link
https://www.nature.com/articles/s41416-025-03005-5
Beijing Origin CISPOLY Biotechnology Co., Ltd. is a technology-driven enterprise committed to health innovation. As a pioneer in the field of early gynecologic oncology diagnosis, CISPOLY has developed early-detection products for cervical cancer, endometrial cancer, and ovarian cancer using proprietary technologies and patent-protected biomarkers, filling a critical gap in the field.
As women pay increasing attention to their own health, the women's health market holds great potential. Beyond the early screening and diagnosis product pipeline for gynecologic oncology, CISPOLY will continue to build additional women's health product lines, establishing itself as a technology-innovation-leading enterprise in the women's health market.