Qualitative and Semi-Quantitative Assay for EGFR Mutations - Vietnam Registration 2403584ĐKLH/BYT-HTTB

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of the defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. The defined EGFR mutations are detected by using DNA extracted from formalin-fixed, paraffin-embedded tumor tissue samples (FFPET) or circulating tumor DNA (cfDNA) in the blood plasma obtained from peripheral whole blood EDTA-anticoagulated blood. The test is indicated as a companion diagnostic to support the selection of NSCLC patients for treatment with EGFR tyrosine kinase inhibitors (including the targeted therapies listed below) as per the labeling of the approved treatment product: - Tarceva® (Erlotinib): + FFPET and Plasma: Deletion of exon 19 and L858R - Tagrisso® (Osimertinib): + FFPET and Plasma: Deletion of exon 19, L858R and T790M - Iressa® (Gefitinib): + FFPET and Plasma: Deletion of exon 19 and L858R. The plasma sample test is the most appropriate for evaluating patients who cannot obtain a tumor biopsy sample. Patients who undergo the plasma sample test and have a negative result for these mutations, if possible, should be re-biopsied and tested for EGFR mutations with the FFPET sample type. The safety and efficacy of the drug have not been established for the subtypes of EGFR mutations below, which are also detected by the cobas® EGFR Mutation Test v2: - Tarceva® (Erlotinib): + FFPET and Plasma: G719X, Exon 20 Insertion, T790M, S768I and L861Q - Tagrisso® (Osimertinib): + FFPET and Plasma: G719X, Exon 20 Insertion, S768I, and L861Q - Iressa® (Gefitinib): + FFPET and Plasma: G719X, Exon 20 Insertion, T790M, S768I and L861Q. The cobas® EGFR Mutation Test v2 for use with plasma includes a semi-quantitative measurement of the mutations in exons 18, 19, 20, and 21 of the EGFR gene. This measurement, reported as a semi-quantitative index (SQI), correlates with the amount of target mutant cfDNA in the plasma and can be used to determine the change in the amount of target mutant cfDNA over time in a patient. For manual sample preparation, the FFPET samples are processed using the cobas® DNA Sample Preparation Kit and the plasma samples are processed using the cobas® cfDNA Sample Preparation Kit. The cobas® z 480 analyzer is used to amplify and detect the mutations automatically.