恭賀：衛生福利部核准日祥PAX1甲基化核酸分子檢測套組
日祥PAX1甲基化核酸分子檢測套組，通過臺灣衛生福利部食品藥物管理署(TFDA)審核，終於在2016年10月取得TFDA核准之第三等級醫療器材許可證。
本產品除可做為子宮頸癌抹片篩檢輔助評估外，抹片測試結合本產品之測試結果，將提供臨床醫師在癌症檢測與術後追蹤工具上有新的選擇，用來減少因檢查而造成的過渡治療與病患恐懼。相信本產品能夠解決臨床醫師的困境，對於疾病預防與醫療品質能有更進一步的突破。
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iStat Biomedical announces the gain of market approval of in vitro diagnostic, EpiGene PAX1 DNA Methylation Detection Kit, by the Taiwan FDA |
iStat Biomedical announces that the proprietary diagnostic product, EpiGene PAX1 DNA Methylation Detection Kit, has received the for the class 3 in vitro diagnostic medical device market approval by Taiwan Food and Drug Administration (TFDA) in October 2016.
This product can be used as an adjunctive tool for cervical cancer Pap screening. When combining the methylation test with the Pap test, the test results provides clinicians with new options for cancer detection and post-surgery monitoring tools. This can reduce over-treatment and patient fear.
EpiGene PAX1 DNA Methylation Detection Kit is a solution for dilemma of clinicians and a breakthrough in disease prevention and medical quality.
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
日祥PAX1甲基化核酸分子檢測套組，通過臺灣衛生福利部食品藥物管理署(TFDA)審核，終於在2016年10月取得TFDA核准之第三等級醫療器材許可證。
本產品除可做為子宮頸癌抹片篩檢輔助評估外，抹片測試結合本產品之測試結果，將提供臨床醫師在癌症檢測與術後追蹤工具上有新的選擇，用來減少因檢查而造成的過渡治療與病患恐懼。相信本產品能夠解決臨床醫師的困境，對於疾病預防與醫療品質能有更進一步的突破。
|
|
iStat Biomedical announces the gain of market approval of in vitro diagnostic, EpiGene PAX1 DNA Methylation Detection Kit, by the Taiwan FDA |
iStat Biomedical announces that the proprietary diagnostic product, EpiGene PAX1 DNA Methylation Detection Kit, has received the for the class 3 in vitro diagnostic medical device market approval by Taiwan Food and Drug Administration (TFDA) in October 2016.
This product can be used as an adjunctive tool for cervical cancer Pap screening. When combining the methylation test with the Pap test, the test results provides clinicians with new options for cancer detection and post-surgery monitoring tools. This can reduce over-treatment and patient fear.
EpiGene PAX1 DNA Methylation Detection Kit is a solution for dilemma of clinicians and a breakthrough in disease prevention and medical quality.
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