TEST:

cobas® EGFR Mutation Test v2

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 DNA derived from formalin-fixed paraffin-embedded tumor tissue (FFPET) from non-small cell lung cancer (NSCLC) patients. The test is intended to designed to detect G719X substitution mutations in exon 18, deletion mutations in exon 19, T790M and S768I substitution mutations and insertion mutations in exon 20, and L858R and L861Q substitution mutations in exon 21. The cobas® EGFR Test is used as a companion diagnostic test for Tarceva® (erlotinib) and Tagrisso® (osimertinib).