日祥獲多家醫學中心支持進行前期多中心臨床研究，驗證甲基化基因標記作為子宮頸癌檢測方法
台灣現行子宮頸癌之檢測方式為二，其一為抹片檢查，但由於抹片的靈敏度仍因不同篩檢設備而有所變異，影響子宮頸癌篩檢功效；另一為人類乳突病毒(HPV)檢測，國外相當多研究即建議可用HPV檢測做為第一線的篩檢工具。雖然現行HPV檢測靈敏度高於抹片檢測，但大部分感染病毒的婦女，會藉由自身的免疫系統將病毒排除。因此，單獨使用HPV檢驗，可能會造成婦女的過度擔憂。
為此，日祥與臺灣婦癌研究組織(TGOG)合作，自2009年12月至2010年11月，與台灣共計11家教學醫院合作進行甲基化臨床試驗，期望藉此篩選出子宮頸癌篩檢最佳組合方案。由臨床試驗結果得知抹片與甲基化基因PAX1或是SOX1合併使用，其檢測結果較優於抹片與HPV合併使用。依照這些重要的實證研究結果，日祥將於近期內啟動大規模的多中心臨床試驗計畫，以此希望為婦癌篩檢盡一份心力。
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iStat Biomedical supported multi-center clinical study: a validation of methylation biomarker for cervical cancer detection |
There are two methods in the Taiwan's current cervical cancer detection, one is Pap smear examination, the other is HPV testing. The sensitivity of Pap smear varies with different screening equipment, which affects the efficacy of cervical cancer screening; While HPV testing, a number of foreign studies suggested that HPV testing can be used as a first-line screening tool. Although the current HPV test is more sensitive than the Pap smear test, most infected women will eliminate the virus by their own immune system. Therefore, HPV testing alone may cause overly concern.
In light of the reason, iStat Biomedical and Taiwan Association of Gynecologist (TGOG) has cooperated with 11 hospitals in Taiwan from December 2009 to November 2010 to conduct methylation clinical study, hoping to identify the best combination for cervical cancer screening program. Results showed that the combination of Pap smear and PAX1 or SOX1 methylation has better detection results than the combination of smear and HPV. Based on these important empirical research results, iStat Biomedical will initiate a large-scale multi-center clinical trial program in the near future, hoping to contribute to the women cancer screening.
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
台灣現行子宮頸癌之檢測方式為二，其一為抹片檢查，但由於抹片的靈敏度仍因不同篩檢設備而有所變異，影響子宮頸癌篩檢功效；另一為人類乳突病毒(HPV)檢測，國外相當多研究即建議可用HPV檢測做為第一線的篩檢工具。雖然現行HPV檢測靈敏度高於抹片檢測，但大部分感染病毒的婦女，會藉由自身的免疫系統將病毒排除。因此，單獨使用HPV檢驗，可能會造成婦女的過度擔憂。
為此，日祥與臺灣婦癌研究組織(TGOG)合作，自2009年12月至2010年11月，與台灣共計11家教學醫院合作進行甲基化臨床試驗，期望藉此篩選出子宮頸癌篩檢最佳組合方案。由臨床試驗結果得知抹片與甲基化基因PAX1或是SOX1合併使用，其檢測結果較優於抹片與HPV合併使用。依照這些重要的實證研究結果，日祥將於近期內啟動大規模的多中心臨床試驗計畫，以此希望為婦癌篩檢盡一份心力。
|
|
iStat Biomedical supported multi-center clinical study: a validation of methylation biomarker for cervical cancer detection |
There are two methods in the Taiwan's current cervical cancer detection, one is Pap smear examination, the other is HPV testing. The sensitivity of Pap smear varies with different screening equipment, which affects the efficacy of cervical cancer screening; While HPV testing, a number of foreign studies suggested that HPV testing can be used as a first-line screening tool. Although the current HPV test is more sensitive than the Pap smear test, most infected women will eliminate the virus by their own immune system. Therefore, HPV testing alone may cause overly concern.
In light of the reason, iStat Biomedical and Taiwan Association of Gynecologist (TGOG) has cooperated with 11 hospitals in Taiwan from December 2009 to November 2010 to conduct methylation clinical study, hoping to identify the best combination for cervical cancer screening program. Results showed that the combination of Pap smear and PAX1 or SOX1 methylation has better detection results than the combination of smear and HPV. Based on these important empirical research results, iStat Biomedical will initiate a large-scale multi-center clinical trial program in the near future, hoping to contribute to the women cancer screening.
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