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 selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:
Table 1: 2
|TARCEVA® (erlotinib)||Exon 19 deletions and L858R||Exon 19 deletions and L858R|
|TAGRISSO® (osimertinib)||Exon 19 deletions, L858R and T790M||Exon 19 deletions, L858R and T790M†|
|IRESSA® (gefitinib)||Exon 19 deletions and L858R||Exon 19 deletions and L858R|
Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA® (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.
† 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 following EGFR mutations also detected by the cobas® EGFR Mutation Test v2:
Table 2: 2
|TARCEVA® (erlotinib)||G719X, Exon 20 insertions, T790M, S768I and L861Q||G719X, exon 20 insertions, T790M, S768I and L861Q|
|TAGRISSO® (osimertinib)||G719X, Exon 20 insertions, S768I, and L861Q||G719X, Exon 20 insertions, S768I, and L861Q|
|IRESSA® (gefitinib)||G719X, Exon 20 insertions, T790M, S768I and L861Q||G719X, exon 20 insertions, T790M, S768I and L861Q|
For 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.