New published Taiwan-based evidence in Gynecologic Oncology, that Cervi-M® serves as triage method to high risk HPV positive women in cervical cancer screening
|
|
New published Taiwan-based evidence in Gynecologic Oncology, that Cervi-M® serves as triage method to high risk HPV positive women in cervical cancer screening |
New Taipei City, April 1st, 2021. iStat Biomedical Co., Ltd. (iStat Co.), published data from multicenter trial, DNA methylation marker for the triage of hrHPV positive women in cervical cancer screening: Real-world evidence in Taiwan, in Gynecologic Oncologya. This is a population-based study involving 4762 women in three hospitals, MacKay Memorial Hospital (MMH), Linkou Chang Gung Memorial Hospital (CGMH), and Lin Shin Hospital (LSH). Three triage tools—cytology, HPV16/18 genotyping, and PAX1 methylation (Cervi-M®)—were analyzed for their clinical performance in hrHPV+ women. Cervi-M® demonstrated comparable accuracy, sensitivity, and specificity to cytology and, better accuracy and specificity than HPV16/18 as the triage tool for detecting CIN3+ in hrHPV+ women. The Cervi-M® assay is thus a promising molecular-based triage tool for early detection of CIN and predicting disease progression in hrHPV+ women.
As majority of the current hrHPV triage studies are focused in the western countries, this study is thus far the very first cohort in Taiwan, as well as in Asia, introducing DNA methylation as triage tool in a real-world screening setting. Cervi-M® is a Taiwan FDA approved in vitro diagnostics (EpiGene PAX1 DNA Methylation Detection Kit, MOHW-MD-No.005348). It is robust and objective in detecting CIN3+ among hrHPV+ women and requires less sample volume than cytology test. With similar performance to cytology test in detecting CIN3, Cervi-M® provides solution for the low- and middle-income countries with a shortage of trained medical professionals, and a lack of good cervical cancer screening infrastructure, therefore cervical cancer is prevalent and is often diagnosed at late stages. As the WHO ambition to eliminate cervical cancer, Cervi-M® as an “add-on” molecular-based test using residual specimen from primary HPV testing makes it possible to have one visit for both primary and triage tests. This is more practical and cost-effective solution to triage severe cervical dysplasia, compared with the strategy to build nationwide cytology screening system in countries with limited resources.
- Chang, C. L., Ho, S. C., Su, Y. F., Juan, Y. C., Huang, C. Y., Chao, A. S., Hsu, Z. S., Chang, C. F., Fwu, C. W., & Chang, T. C. (2021). DNA methylation marker for the triage of hrHPV positive women in cervical cancer screening: Real-world evidence in Taiwan. Gynecologic oncology, 161(2), 429–435. https://doi.org/10.1016/j. ygyno.2021.02.011
For more information, please visit: https://tw.epigenebio.com/
About iStat Biomedical
iStat Biomedical is a Taiwan-based biotechnology company specialized in the development and manufacturing of gene methylation assay IVD products for the early detection of cancers. iStat Biomedical develops innovative products that are primarily used in the clinical laboratories, and provides physicians with alternative solutions for clinical managements. iStat Biomedical also provides services for gene methylation detection and IVD contract manufacturing.
iStat Biomedical Co., Ltd contact:
+886-2-26963518
|
|
New published Taiwan-based evidence in Gynecologic Oncology, that Cervi-M® serves as triage method to high risk HPV positive women in cervical cancer screening |
New Taipei City, April 1st, 2021. iStat Biomedical Co., Ltd. (iStat Co.), published data from multicenter trial, DNA methylation marker for the triage of hrHPV positive women in cervical cancer screening: Real-world evidence in Taiwan, in Gynecologic Oncologya. This is a population-based study involving 4762 women in three hospitals, MacKay Memorial Hospital (MMH), Linkou Chang Gung Memorial Hospital (CGMH), and Lin Shin Hospital (LSH). Three triage tools—cytology, HPV16/18 genotyping, and PAX1 methylation (Cervi-M®)—were analyzed for their clinical performance in hrHPV+ women. Cervi-M® demonstrated comparable accuracy, sensitivity, and specificity to cytology and, better accuracy and specificity than HPV16/18 as the triage tool for detecting CIN3+ in hrHPV+ women. The Cervi-M® assay is thus a promising molecular-based triage tool for early detection of CIN and predicting disease progression in hrHPV+ women.
As majority of the current hrHPV triage studies are focused in the western countries, this study is thus far the very first cohort in Taiwan, as well as in Asia, introducing DNA methylation as triage tool in a real-world screening setting. Cervi-M® is a Taiwan FDA approved in vitro diagnostics (EpiGene PAX1 DNA Methylation Detection Kit, MOHW-MD-No.005348). It is robust and objective in detecting CIN3+ among hrHPV+ women and requires less sample volume than cytology test. With similar performance to cytology test in detecting CIN3, Cervi-M® provides solution for the low- and middle-income countries with a shortage of trained medical professionals, and a lack of good cervical cancer screening infrastructure, therefore cervical cancer is prevalent and is often diagnosed at late stages. As the WHO ambition to eliminate cervical cancer, Cervi-M® as an “add-on” molecular-based test using residual specimen from primary HPV testing makes it possible to have one visit for both primary and triage tests. This is more practical and cost-effective solution to triage severe cervical dysplasia, compared with the strategy to build nationwide cytology screening system in countries with limited resources.
- Chang, C. L., Ho, S. C., Su, Y. F., Juan, Y. C., Huang, C. Y., Chao, A. S., Hsu, Z. S., Chang, C. F., Fwu, C. W., & Chang, T. C. (2021). DNA methylation marker for the triage of hrHPV positive women in cervical cancer screening: Real-world evidence in Taiwan. Gynecologic oncology, 161(2), 429–435. https://doi.org/10.1016/j. ygyno.2021.02.011
For more information, please visit: https://tw.epigenebio.com/
About iStat Biomedical
iStat Biomedical is a Taiwan-based biotechnology company specialized in the development and manufacturing of gene methylation assay IVD products for the early detection of cancers. iStat Biomedical develops innovative products that are primarily used in the clinical laboratories, and provides physicians with alternative solutions for clinical managements. iStat Biomedical also provides services for gene methylation detection and IVD contract manufacturing.
iStat Biomedical Co., Ltd contact:
+886-2-26963518