ICervsure
DNA Methylation Dection kit for Cervical Cancer
ICervsure is a non-invasive detection kit for in vitro qualitative detection of methylated SOX1 and PAX1 genes in cervical exfoliated cells of individuals who are tested positive for HPV, or diagnosed, through clinical cytology tests, with the results of ASC-US (atypical squamous cells of ambiguous significance), ASC-H (atypical cells of high-grade squamous intraepithelial lesions that could not be excluded), LSIL (low-grade squamous intraepithelial lesions) and HSIL (high-grade squamous intraepithelial lesions).
Why ICervsure?
Cervical cancer is the fourth most common cancer among women globally, with an estimated 604,000 new cases and 342,000 deaths in 2020. About 90% of the new cases and deaths worldwide in 2020 occurred in low- and middle-income countries. Two human
papillomavirus (HPV) types (16 and 18) are responsible for nearly 50% of high grade cervical pre-cancers.
But HPV is not the only cause of cervical cancer. Most women with HPV don’t get cervical cancer, and other risk factors, like smoking, Chlamydia infection, Long-term use of oral contraceptives can increase chance of developing cervical cancer.
Cervical cancer is one of the most preventable and treatable forms of cancer, as long as it is detected early and managed effectively.
Staging of Cervical Cancer
Why SOX1 and PAX1?
ICervsure Positive rates (95% CI)
| CIN1 | CIN2 | CIN3 | CA | Negative | |
ICervsure Posivitive rate |
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Abnormal DNA methylation is correlated with many human diseases including tumors.
In cervical cancer tissues, the cytosines in the CpG region of SOX1 and PAX1 genes are methylated, while the methylation rarely occurs in normal cervical tissues.
Researchers have found that the combined detection of SOX1 and PAX1 methylation can be used as an early indicator for cervical cancer screening.
Therefore, the above indicators are used as biomarkers of cervical cancer and precancerous lesions, and the detection of the methylation levels of SOX1 and PAX1 genes in cervical exfoliated cells can be used as ancillary diagnosis for cervical precancerous lesions and and early cervical cancer.
The Advantage of ICervsure
Accuracy
The sensitivity for detection of cancer is 100% and for precancerous lesions is 58.28%,The specificity is 90.3%.
Simple sampling
ICervsure can be performed on the same sample (self-sample or physician/ gynecologist collected) as the primary screening HPV test.
Easy operation
ICervsure can be performed on the mainstream brand qPCR machine.
Objective results
ICervsure provides objective results on whether a patient has a hrHPV infection that’s actively transforming cervical cells into cancer.
Save time & money
Avoid Unnecessary Colposcopy and Cervical Treatments.
Reduce anxiety
ICervsure provides test negative patients with peace of mind that they have a low short-term risk of cervical cancer.
Kit Components of ICervsure
Cell Direct Bisulfite Modification Kit
DNA Methylation Detection Kit for Cervical Cancer (Real-Time PCR)
Testing Procedures
Sample collection
Pretreatment and extraction
Bisulfite conversion and purification
qPCR procedure
Analysis and Report
Sample collection
Pretreatment and extraction
Bisulfite conversion and purification
qPCR procedure
Analysis and Report
Result Interpretation
If the sample is tested positive, it means that the subject is at high risk of cervical precancerous lesions or early cervical cancer at the time of testing. A clinical diagnosis is recommended. If the sample is tested negative, it means that the subject is at low risk of cervical precancerous lesions or cancer at the time of testing. The subject is recommended to receive regular cervical cancer screening tests.
Gene methylation |
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| PAX1 | SOX1 | |
| Positive | Positive |
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| Positive | Negative | |
| Negative | Positive | |
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