iStat Biomedical Co., Ltd. - Epigene

Cervi-M, Oral-M, 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

Intended Use PAX1 DNA Detection Kit is a diagnostic kit for the qualitative detection of methylated PAX1 in bisulfite-converted DNA from human cells. Depend on the cells used, a positive results correlated with the risk of cervical/or oral cancers. For cervical cancer, the cervical cells were collected by using of cervical brush. For oral cancer, the cells were collected by oral swab. PAX1 DNA Detection Kit manufactured followed to the requirements of the directive for in vitro diagnostics (98/79/EC). Therefore it carries a CE mark. All the test results have to be evaluated by physician in combination with other clinical and laboratory findings. 【Download Package Insert】 【Download MSDS】 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)

Intended Use PAX1 DNA Detection Kit is a diagnostic kit for the qualitative detection of methylated PAX1 in bisulfite-converted DNA from human cells. Depend on the cells used, a positive results correlated with the risk of cervical/or oral cancers. For cervical cancer, the cervical cells were collected by using of cervical brush. For oral cancer, the cells were collected by oral swab. PAX1 DNA Detection Kit manufactured followed to the requirements of the directive for in vitro diagnostics (98/79/EC). Therefore it carries a CE mark. All the test results have to be evaluated by physician in combination with other clinical and laboratory findings. 【Download Package Insert】 【Download MSDS】 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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