CISOVA® Clinical Guide (Series III): Target Population and Clinical Pathway
Through
Series 2 CISOVA® Clinical Interpretation (Series 2): Multicenter Clinical Trial Evidence
we have examined the breakthrough value and outstanding performance of the CISOVA® (CDO1/HOXA9) gene methylation detection kit in early diagnosis of ovarian cancer.
This article will ultimately focus on clinical practice, clarifying the specific applicable populations, convenient sampling methods, and clear positive result management pathways, elaborating on its application value throughout the entire disease management cycle.
1. Defining Applicable Populations: Precisely Targeting High-Risk and Suspected Individuals
CISOVA® is applicable for early risk screening and auxiliary diagnosis of ovarian cancer in the following populations:
1.Key age groups: Women aged 35 and above, especially perimenopausal and postmenopausal women.
2.Non-specific symptom populations: Individuals presenting with persistent bloating, abdominal pain, pelvic discomfort, digestive abnormalities, urinary frequency/urgency, fatigue, and other non-specific symptoms, but without definitive diagnosis on imaging (such as ultrasound).
3.Abnormal indicator populations: Individuals found to have mildly or persistently elevated tumor markers such as CA125 on health checkups, requiring further differential diagnosis.
4.High-risk populations: Women with a family history of ovarian or breast cancer; individuals carrying hereditary tumor gene mutations such as BRCA1/2.
5.Treatment follow-up populations: Ovarian cancer patients who have completed initial treatment and are in the follow-up period, for monitoring recurrence risk.
6.Health-conscious populations: Healthy or high-risk women who wish to undergo early risk screening using high-sensitivity, non-invasive technology.
2. Convenient Testing and Clear Clinical Pathways
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·Sampling method: Only requires collection of 5mL of peripheral blood in a standard blood collection tube — convenient and non-invasive.
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·Result interpretation and action recommendations:
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oPositive result: Indicates high ovarian cancer risk. Immediate referral to a gynecology or gynecologic oncology specialist clinic is recommended. Clinicians should conduct comprehensive evaluation and diagnosis combining pelvic ultrasound, pelvic MRI, or other imaging examinations or biopsy pathology.
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oNegative result: Indicates low ovarian cancer risk. Regular health follow-up is recommended based on individual circumstances (such as presence of other high-risk factors).
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3. Management Value Throughout the Full Cycle
The application value of CISOVA® is not limited to early diagnosis. For confirmed ovarian cancer patients, establishing a methylation baseline from sampling before treatment and performing regular testing during postoperative follow-up can provide earlier indication of molecular-level recurrence risk than traditional imaging examinations by observing dynamic changes in methylation levels. This offers a critical window for clinical treatment plan adjustments and early intervention, enabling more precise full-cycle health management.
Through innovative technology, the CISOVA® gene methylation test resolves the challenges of early ovarian cancer diagnosis. Expert consensus has elucidated its non-invasive advantages based on liquid biopsy, outstanding early detection performance (particularly high sensitivity for Stage I cancer), and broad clinical applicability, making it a potentially important tool in the gynecologic tumor early screening and auxiliary diagnosis system [1]. Its approval and simple usage make it a leading tool for early diagnosis of gynecologic tumors. High-risk women or those with relevant symptoms are advised to consult their physician for CISOVA® non-invasive testing.
References
[1] Tumor Biomarker Professional Committee, China Anti-Cancer Association. Expert Consensus on Detection and Clinical Application of Tumor DNA Methylation Biomarkers (2024 Edition). Chinese Journal of Oncology Prevention and Treatment, 2024.
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.