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Expert Consensus | 2025 Molecular Testing Technologies for Cervical Cancer Screening and Early Diagnosis Highlight the Importance of Methylation Testing

The Gynecology Branch of the Chinese Geriatrics Society organized relevant domestic experts to develop and publish the Chinese Expert Consensus on Molecular Testing Technology for Cervical Cancer Screening and Early Diagnosis (2025 Edition) through literature review, evidence extraction, and collective discussion. This consensus is based on the current status of cervical cancer screening and advances in molecular testing technology in China, aiming to summarize and standardize the application of molecular technologies such as HPV testing and DNA methylation detection in cervical cancer screening and early diagnosis, providing stronger technical support and pathway references for clinical practice.

Consensus Recommendation: The application of cervical exfoliated cell methylation detection in cervical cancer screening is becoming increasingly important. It can be used for combined TCT and HPV screening, and for triage testing of HR-HPV-positive patients or ASCUS/LSIL patients (Recommendation Level 2A).

The following are excerpts from this consensus regarding methylation detection:

I. DNA Methylation Detection Incorporated into Cervical Cancer Molecular Screening

The consensus explicitly recommends HPV testing and DNA methylation detection as molecular screening technologies for cervical cancer and precancerous lesions, with particular emphasis on the application value of methylation detection in screening and triage management. It also provides a clear recommendation for the application of cervical exfoliated cell methylation detection in cervical cancer screening.

II. Highlights of DNA Methylation Technology

DNA methylation detection identifies rapidly progressing high-grade lesions:

The consensus notes that cervical cancer-associated methylation changes can appear at even earlier stages, helping to identify high-risk populations as early as possible and guide early clinical intervention, and is therefore regarded as an important new approach for future cervical cancer prevention.

Clinical value: Reducing unnecessary colposcopy referrals:

In HR-HPV-positive populations, methylation detection can be used for risk stratification, helping to reduce unnecessary colposcopy referrals. In borderline populations such as ASCUS/LSIL, it can also serve as a tool for further triage and prediction of progression/outcome.

III. Consensus Highlights Clinical Features and Value of PAX1/JAM3 Dual-Gene Methylation Detection

  1. Multiple methylation biomarkers have entered the clinical application stage, with the kit based on PAX1 and JAM3 dual-gene methylation detection (CISCER) listed as a representative commercialized product.

  2. The consensus details the PAX1 and JAM3 gene methylation detection kit (PCR-fluorescent probe method) in the "NMPA-approved HPV methylation detection kits" section, including sample types and intended uses (clinical positioning).

Source:

He Y, Wu Y, Zhang S, Wang J, Meng Y, & Zhao H. (2025). Chinese expert consensus on molecular testing technology for cervical cancer screening and early diagnosis (2025 edition). Chinese Journal of Health Care Medicine, 27(06), 925–932. [DOI] 10.3969/j.issn.1674-3245.2025.06.001

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CISPOLY

Beijing Origin-Poly Co., Ltd. is a technology enterprise driven by innovation and committed to health. As a pioneer in the field of early diagnosis of gynecologic tumors, CISPOLY has developed early detection products for cervical cancer, endometrial cancer, ovarian cancer and other gynecologic malignancies based on proprietary technologies and patent-protected biomarkers, filling gaps in this field.

As women's awareness of their own health continues to grow, the women's health market holds tremendous potential. Beyond the gynecologic tumor early screening and diagnosis product line, CISPOLY will continue to establish additional women's health-related product pipelines, striving to become a technology innovation leader in the women's health market.