iStat Biomedical Co., Ltd. - Epigene

iStat, Epigene, Epigenebio, Cervical cancer test, Oral cancer test, Cancer methylation test, Epigenetic IVD assay, Non-invasive early cancer detection, DNA Methylatoin, 日祥, 甲基化基因檢測, 癌症基因檢測

Quality and Compliance Indicators ISO 13485, ISO 9001, GMP, IVD-CE Specimens of use Human epithelial cells (cell scrapings off swabs) Recommended Real-time PCR System: LightCycler® 480 Instrument or Applied Biosystems® 7500 fast Analytical and clinical performances Data generated from multicenter clinical trials demonstrated that the PAX1 DNA Methylation assays are excellent tool for the detection of cervical cancers graded CIN3 and above. The assay generates clinical sensitivity and specificity of more than 80%, when used with the Pap smears. Reference Int. J Cancer:123,161-167. (2008) Cancer: Sep. 15, 4266-4274. (2010)

Quality and Compliance Indicators ISO 13485, ISO 9001, GMP, IVD-CE Specimens of use Human epithelial cells (cell scrapings off swabs) Recommended Real-time PCR System: LightCycler® 480 Instrument or Applied Biosystems® 7500 fast Analytical and clinical performances Data generated from multicenter clinical trials demonstrated that the PAX1 DNA Methylation assays are excellent tool for the detection of cervical cancers graded CIN3 and above. The assay generates clinical sensitivity and specificity of more than 80%, when used with the Pap smears. Reference Int. J Cancer:123,161-167. (2008) Cancer: Sep. 15, 4266-4274. (2010)
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