子宫内膜癌 CDO1 / CELF4 双基因甲基化

禾蔻安 CISENDO®

全球首个无创子宫内膜癌筛查，填补临床空白

CDO1/CELF4 双基因甲基化，无创采样替代有创活检，全球首个无创内膜癌筛查，填补临床空白。

NMPA 注册证

国械注准 20243402610

获证时间

2024.12

临床效能 · Clinical Data

扎实的临床数据支撑

基于多中心注册临床试验，灵敏度与特异性均达到行业领先水平。

灵敏度（内膜癌）94.51%

注册临床试验

特异性94.16%

注册临床试验

4,818例

注册临床样本

12,000例真实世界

多中心研究

宫颈脱落细胞（无创采样）

采样方式

目标人群

谁需要这项检测？

异常子宫出血女性
绝经后女性子宫内膜癌筛查
围绝经期女性内膜病变风险评估
拟行宫腔镜检查的高风险女性

使用场景

临床如何应用？

子宫内膜癌无创早筛
宫腔镜术前风险分层，减少不必要的有创检查
高危人群的随访与监测
体检中心女性健康筛查方案

核心优势 · Highlights

为什么选择我们

全球首个无创子宫内膜癌甲基化检测产品

全球专利、CE 认证、马来西亚注册证

获《子宫内膜癌三级预防策略中国专家共识》推荐

获《子宫内膜癌基因甲基化筛查技术临床应用专家共识》推荐

常见问题 · FAQ

关于这项检测的常见疑问

禾蔻安 CISENDO® 是什么检测？

禾蔻安 CISENDO® 检测宫颈脱落细胞 CDO1/CELF4 双基因甲基化的 III 类体外诊断产品（国械注准 20243402610），是全球首个无创子宫内膜癌筛查产品。

CISENDO 检测准确率如何？

注册临床试验（4,818 例样本）显示：内膜癌灵敏度 94.51%、特异性 94.16%；另有 12,000 例真实世界多中心研究支持。

CISENDO 能替代宫腔镜和内膜活检吗？

CISENDO 为无创筛查手段，采宫颈脱落细胞即可完成，可帮助评估内膜癌风险、减少不必要的有创检查；确诊仍需宫腔镜/活检病理，但可作为高效的分流的初步分层。

异常子宫出血为什么要查甲基化？

异常子宫出血是内膜癌最常见的就诊症状，甲基化检测可无创评估恶变风险，帮助医生决定是否需要进一步有创检查，避免延误或过度检查。

哪些人适合做 CISENDO 检测？

异常子宫出血女性、绝经后女性、围绝经期内膜病变风险人群，以及拟行宫腔镜检查的高风险女性。

循证依据

子宫内膜癌相关学术文献

Validation of a cervical CDO1/CELF4 methylation test for endometrial cancer: a prospective paired-sample comparison with intrauterine specimen

期刊：Frontiers in Medicine

发表单位：Gansu Provincial Maternity and Child-care Hospital

DOI: 10.3389/fmed.2026.1690020

禾蔻安 CISENDO®

扎实的临床数据支撑

谁需要这项检测？

临床如何应用？

为什么选择我们

关于这项检测的常见疑问

子宫内膜癌 相关学术文献

Validation of a cervical CDO1/CELF4 methylation test for endometrial cancer: a prospective paired-sample comparison with intrauterine specimen

Development and validation of hypermethylated gene markers in cervical cytological samples for detecting endometrial cancer (EndoMethy-I trial)

Diagnostic Accuracy and Concordance of Self-Collected Cervical CDO1 and CELF4 Methylation Testing Compared With Physician Sampling for Endometrial Cancer Detection

Analytical and clinical validation of the EdenDx methylation assay as a noninvasive supportive triage tool for early detection of endometrial cancer in cervical scraping specimens

Self-Sampling for CDO1/CELF4 Methylation Accurately Identifies Endometrial Cancer in a Resource-Limited Region: A Prospective Study From Gansu

Clinical Validation of DNA Methylation Detection in Cervical Exfoliated Cells for Endometrial Cancer in Women with Suspected Lesions

CDO1 and CELF4 methylation assay as the dominant predictor of endometrial cancer: A cohort analysis across pre- and post-menopausal cohorts

Prospective Evaluation of Cervical Scrapings CDO1 and CELF4 Methylation (epiHERA?) Assay in Detection of Endometrial Cancer

The endometrial cancer detection using non-invasive hypermethylation of CDO1 and CELF4 genes in women with postmenopausal bleeding in Northwest China

DNA methylation detection is a significant biomarker for screening endometrial cancer in premenopausal women with abnormal uterine bleeding

禾蔻安双基因甲基化检测在子宫内膜癌筛查中的应用价值

DNA甲基化检测在绝经后女性子宫内膜癌筛查中的应用价值

DNA甲基化检测在育龄期异常子宫出血女性子宫内膜癌诊断中的应用价值

Hypermethylated CDO1 and CELF4 in cytological specimens as triage strategy biomarkers in endometrial malignant lesions.

Validation of a cervical CDO1/CELF4 methylation test for endometrial cancer: a prospective paired-sample comparison with intrauterine specimen

Development and validation of hypermethylated gene markers in cervical cytological samples for detecting endometrial cancer (EndoMethy-I trial)

Diagnostic Accuracy and Concordance of Self-Collected Cervical CDO1 and CELF4 Methylation Testing Compared With Physician Sampling for Endometrial Cancer Detection

Analytical and clinical validation of the EdenDx methylation assay as a noninvasive supportive triage tool for early detection of endometrial cancer in cervical scraping specimens

Self-Sampling for CDO1/CELF4 Methylation Accurately Identifies Endometrial Cancer in a Resource-Limited Region: A Prospective Study From Gansu

Clinical Validation of DNA Methylation Detection in Cervical Exfoliated Cells for Endometrial Cancer in Women with Suspected Lesions

CDO1 and CELF4 methylation assay as the dominant predictor of endometrial cancer: A cohort analysis across pre- and post-menopausal cohorts

Prospective Evaluation of Cervical Scrapings CDO1 and CELF4 Methylation (epiHERA?) Assay in Detection of Endometrial Cancer

The endometrial cancer detection using non-invasive hypermethylation of CDO1 and CELF4 genes in women with postmenopausal bleeding in Northwest China

DNA methylation detection is a significant biomarker for screening endometrial cancer in premenopausal women with abnormal uterine bleeding

禾蔻安双基因甲基化检测在子宫内膜癌筛查中的应用价值

DNA甲基化检测在绝经后女性子宫内膜癌筛查中的应用价值

DNA甲基化检测在育龄期异常子宫出血女性子宫内膜癌诊断中的应用价值

Hypermethylated CDO1 and CELF4 in cytological specimens as triage strategy biomarkers in endometrial malignant lesions.

相关指南与共识

子宫内膜癌基因甲基化筛查技术临床应用专家共识（2026版）

子宫内膜癌三级预防策略中国专家共识（2025年版）

肿瘤DNA甲基化标志物检测及临床应用专家共识（2024版）

子宫内膜癌相关学术文献