DNA Methylation Testing Strongly Recommended by Chinese Expert Consensus; CISCER Leads Innovation in Cervical Cancer Screening Technology
In December 2025, the Gynecology Branch of the Chinese Geriatrics Society officially released the Chinese Expert Consensus on Molecular Testing Technology for Cervical Cancer Screening and Early Diagnosis (2025 Edition), establishing for the first time systematically the key position of DNA methylation detection in the cervical cancer screening pathway, injecting new technological momentum into the cervical cancer prevention and control system.
I. Methylation Detection: A Precision Weapon for Cervical Cancer Screening
The consensus explicitly states that DNA methylation is a key mechanism involving hypermethylation of tumor suppressor gene promoters leading to abnormal gene expression in cancer cells—an early molecular event in cervical carcinogenesis. This technology enables early identification of high-grade cervical lesions, providing a valuable time window for clinical intervention, and has become a new-generation important tool for cervical cancer prevention.
II. Addressing Clinical Pain Points: From Overtreatment to Precision Management
Traditional HPV testing, while highly sensitive, lacks specificity, leading to large numbers of individuals with transient infections facing unnecessary colposcopy referrals and psychological burden. The emergence of methylation detection technology effectively addresses this clinical deficiency.
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).
III. CISCER's Technological Superiority and Demonstrated Value in Multiple Clinical Scenarios
CISPOLY has deeply cultivated the gynecologic tumor methylation detection field, with a product pipeline covering cervical cancer, endometrial cancer, ovarian cancer, and other key cancer types—all related detection products have obtained NMPA Class III medical device registration. Among these, CISCER (PAX1/JAM3), as the first approved cervical cancer methylation detection product, has demonstrated significant application value in multiple clinical scenarios:
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Precision triage of high-risk populations: For HR-HPV primary screening-positive populations, CISCER can effectively distinguish transient infection from persistent high-risk infection, potentially reducing unnecessary colposcopy referrals by approximately 67%, alleviating medical burden and psychological pressure on those screened.
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Auxiliary management of difficult cases: In cases with abnormal cytology results (such as ASCUS/LSIL) or equivocal colposcopic findings, CISCER can serve as an objective molecular indicator to assist in assessing lesion progression risk, enabling individualized precision follow-up and management.
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Treatment efficacy and recurrence monitoring: Particularly after local excision or ablation for high-grade cervical lesions, CISCER can provide molecular evidence for efficacy assessment and recurrence risk monitoring through "dynamic monitoring" of methylation level changes, supporting full-course disease management.
With the continued development of molecular testing technology, methylation detection is poised to deliver even greater value in cervical cancer prevention. The promotion and application of innovative products such as CISCER will help achieve the WHO's strategic goal of "eliminating cervical cancer," safeguarding women's health.
Reference
Gynecology Branch of the Chinese Geriatrics Society, He Y, Wu Y, et al. Chinese expert consensus on molecular testing technology for cervical cancer screening and early diagnosis (2025 edition) [J]. Chinese Journal of Health Care Medicine, 2025, 27(6): 925–932. DOI:10.3969/j.issn.1674-3245.2025.06.001.
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.