CISENDO® Clinical Guide (III) | Do You Need This Test?
The CISENDO® (CDO1/CELF4) gene methylation detection kit received NMPA Class III medical device registration (Registration No.: 20243402610) in December 2024. As the world's first non-invasive endometrial cancer early diagnostic test based on cervical exfoliated cell samples, its launch benefits many women and marks the entry of endometrial cancer early screening technology into a new stage of non-invasive, convenient, and precise detection.
CISENDO® achieves highly precise detection with 94.51% sensitivity and 94.16% specificity through the same non-invasive sampling method as HPV testing. It not only provides comprehensive early warning of carcinogenesis but also effectively compensates for blind spots in traditional imaging examinations, serving as an innovative tool for endometrial cancer screening.
After learning about endometrial cancer risks and new screening technologies, many women ask: Am I in a high-risk group? How is this test performed? The following information provides clear guidance.
1. Who Is Particularly Suitable for CISENDO® Testing?
This test is applicable for broad health management and risk screening, with particular recommendation for the following populations to consult for evaluation:
(1). Those with abnormal symptoms: Especially women with abnormal uterine bleeding (such as postmenopausal bleeding, menstrual irregularities, menorrhagia, or prolonged menstruation).
(2). Those with metabolic diseases: Such as obesity, diabetes, hypertension, etc. — high-risk populations for endometrial cancer.
(3). Those with specific medical or family history: Including polycystic ovary syndrome (PCOS) patients, women with a family history of endometrial cancer or colorectal cancer, and those on long-term unopposed estrogen therapy.
(4). Those needing auxiliary diagnosis: Cases where transvaginal ultrasound or other imaging shows abnormally thickened endometrium or space-occupying lesions, or where tumor markers such as CA125 are abnormal, requiring auxiliary benign-malignant differentiation.
(5) Health-conscious and proactive managers: Healthy or high-risk women who wish to undergo early risk screening using high-sensitivity, non-invasive technology.
2. CISENDO® Enables Early Detection of Endometrial Cancer — Earlier Treatment Means Less Burden
The five-year survival rate for endometrial cancer gradually declines from over 90% to below 30%, with correspondingly shortened expected survival time. Meanwhile, treatment costs escalate from routine annual checkup expenses (hundreds of yuan), to tens of thousands of yuan for early-stage treatment, and potentially to hundreds of thousands or even millions of yuan at advanced stages.
Therefore, for women who meet screening indications, proactively undergoing high-precision, non-invasive early detection such as CISENDO® is a key step in shifting the "gateway forward" in personal health management. This not only significantly improves the hope of cure but also effectively avoids the heavy health and economic burdens that may be faced in the future, making it the most cost-effective way to achieve the health goals of "early diagnosis, early treatment, improved survival, and reduced costs."
Figure 1: CISENDO® enables earlier detection of endometrial cancer — early detection, early treatment
3. Testing Process and Result Interpretation
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· Sampling method: Very simple. Performed by professionals at a medical facility, the sampling process is identical to routine cervical HPV/TCT examination — non-invasive, painless, and completed in minutes.
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· Can be combined with imaging (such as transvaginal ultrasound) or tumor marker testing.
·Result interpretation:
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o Positive result: Indicates a relatively high risk of endometrial carcinogenesis. It is recommended to promptly visit a gynecology or gynecologic oncology specialist clinic, where a physician will combine clinical findings to determine whether further examinations such as hysteroscopy are needed for definitive diagnosis.
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o Negative result: Indicates a relatively low current risk of endometrial carcinogenesis. It is recommended to maintain a healthy lifestyle and follow physician recommendations for regular follow-up.
4. Conclusion and Outlook
With its advantages of non-invasiveness, high sensitivity, and high specificity, the CISENDO® gene methylation test provides a transformative solution for early screening and risk stratification of endometrial cancer. It is particularly suited to address current clinical issues of diagnostic delays or excessive invasive examinations caused by limitations of traditional methods.
Women who meet the above high-risk characteristics or are concerned about their reproductive health are advised to proactively discuss with their physician the applicability of CISENDO® testing. Early detection is key to overcoming cancer, and proactive screening is an important step in safeguarding health.
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.