Quantitative Methylation Status Assay for the Exon 1 of the MGMT Gene - Vietnam Registration 2301630ĐKLH/BYT-HTTB

The therascreen MGMT Pyro Kit is an in vitro diagnostic test used to detect the sequence of nucleic acid based on the Pyrosequencing® technology to quantify the methylation status in the exon 1 of the MGMT gene in the DNA from human tissue samples. The therascreen MGMT Pyro Kit is used as an additional diagnostic test alongside other predictive factors and provides the clinical oncologist with information to select patients who are likely to benefit from chemotherapy. It is intended for in vitro diagnostic use. It is intended for use on the PyroMark® Q24 system. The PyroMark Q24 system consists of the following products: • The PyroMark Q24 and PyroMark Q24 MDx instruments. • The PyroMark Q24 Vacuum Workstation and the PyroMark Q24 MDx Vacuum Workstation. • The PyroMark Q24 Software (version 2.0) and the PyroMark Q24 MDx Software (version 2.0). The products are intended to be used by qualified individuals, such as laboratory technicians and medical laboratory personnel, who are trained in in vitro diagnostic testing, molecular biology, and the PyroMark Q24 system.