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China's First 2025 Expert Consensus on Standardized Selection of Cervical Cancer Gene Testing! PAX1/JAM3 Methylation Testing Precisely Targets High-Risk Populations, Reducing Colposcopy Referral Rates and Patient Burden

The China Anti-Cancer Association Integrated Chinese-Western Ovarian Cancer Professional Committee, through an expert consensus development panel on standardized selection of gene testing for cervical cancer based on clinical needs, invited top domestic experts to jointly develop the Chinese Expert Consensus on Standardized Selection of Gene Testing for Cervical Cancer Based on Clinical Needs (2025 Edition), which was officially released. This consensus standardizes the application of gene testing throughout the entire process of cervical cancer prevention, screening, diagnosis, and treatment, promoting the construction of a precision cervical cancer prevention and control system. The consensus explicitly establishes the important position of gene testing in cervical cancer screening and triage, and lists DNA methylation detection as an important triage tool for HR-HPV-positive or cytology-abnormal patients.

1. Consensus Summary

The consensus notes that HPV-DNA combined with cytology remains the first-line screening method, but HPV E6/E7 mRNA and DNA methylation detection can compensate for the inadequacies of traditional methods, helping distinguish transient HPV infection from high-risk patients requiring further diagnosis and treatment, thereby reducing unnecessary colposcopy examinations and overtreatment. The sensitivity and specificity of methylation detection are no lower than those of liquid-based thin-layer cytology, and it can be used alone or in combination with other methods for triage of HR-HPV-positive patients.

Among these, DNA methylation detection has become a technology direction of particular interest in the consensus due to its ability to directly reflect gene regulatory status and identify precancerous lesion risk. Multiple studies have shown that methylation biomarkers perform excellently in improving screening specificity and reducing unnecessary colposcopy referrals.

2. Clinical Features and Value of PAX1/JAM3 Dual-Gene Detection

The consensus particularly emphasized the advantages of PAX1/JAM3 methylation in triage. A multicenter prospective study showed that in non-16/18 high-risk HPV-infected patients, PAX1/JAM3 methylation detection rate for CINII+ was significantly superior to conventional cytology. When liquid-based thin-layer cytology results were ASC-US or above, using PAX1/JAM3 methylation(+) as the triage criterion reduced the colposcopy referral rate from 74.66% to 17.45%, significantly reducing unnecessary referrals and patient burden.

3. Conclusion

This expert consensus provides an authoritative basis for clinical promotion of gene methylation detection, especially the PAX1/JAM3 dual-gene detection, which demonstrates efficient, operable clinical value in triage of HPV-positive patients. For medical institutions seeking to both improve lesion detection and reduce unnecessary invasive examinations, the methylation detection protocols recommended by the consensus are worth particular consideration and application.

  1. Consensus Citation

Recommendation 1:

HPV-DNA combined with cytology is the first-line cervical cancer screening method. Methylation detection can compensate for the inadequacies of traditional detection methods and help distinguish HPV infection status: methylation detection has sensitivity and specificity no lower than TCT, and can be used alone or in combination for triage of HR-HPV-positive patients (Evidence level: moderate, Recommendation strength: strong).

Source: Chinese Expert Consensus on Standardized Selection of Gene Testing for Cervical Cancer Based on Clinical Needs (2025 Edition). Journal of Oncology: 2025 Vol. 31 No. 7, pp. 557-566, DOI:10.11735/j.issn.1671-170X.2025.07.B001

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CISPOLY

Beijing Origin CISPOLY Biotechnology Co., Ltd. is a technology enterprise driven by innovative science and focused on health. CISPOLY is a pioneer in the field of early diagnosis of gynecologic tumors. With proprietary technology and patent-protected biomarkers at its core, the company has developed early diagnostic products for cervical cancer, endometrial cancer, ovarian cancer, and other gynecologic tumors, filling a void in this field.

As women pay increasing attention to their own health, the women's health market holds great promise. Beyond its gynecologic tumor early screening and diagnosis product line, CISPOLY will continue to build additional women's health-related product pipelines, striving to become a technology-innovation-driven leader in the women's health market.