Roche Diagnostics USA

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in identifying patients with NSCLC for treatment with a tyrosine kinase inhibitor in accordance with the approved therapeutic product labeling:Table 1: DrugFFPETPlasmaEGFR Tyrosine Kinase Inhibitors approved by FDA*Exon 19 Deletions, L858RExon 19 Deletions, L858RAdditional indications in accordance with approved therapeutic product labelingTAGRISSO® (osimertinib)T790MT790M***For the most current information about the therapeutic products in this group, go to:https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm.Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (See Note** for T790M). Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.Note : **The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the EGFR mutations listed that are also detected by the cobas® EGFR Mutation Test v2:Table 2: DrugFFPETPlasmaTARCEVA® (erlotinib)G719X, Exon 20 insertions, T790M, S768I and L861QG719X, Exon 20 insertions, T790M, S768I and L861QTAGRISSO® (osimertinib)G719X, Exon 20 insertions, S768I, and L861QG719X, Exon 20 insertions, S768I, and L861QIRESSA® (gefitinib)G719X, Exon 20 insertions, T790M, S768I and L861QG719X, Exon 20 insertions, T790M, S768I and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas® z 480 analyzer is used for automated amplification and detection.