therascreen® EGFR RGQ PCR Kit: A Companion Diagnostic for Afatinib and Gefitinib in Non-Small Cell Lung Cancer.

therascreen(®) EGFR RGQ PCR Kit is a real-time polymerase chain reaction test kit for the qualitative detection of exon 19 deletions and L858R mutation of the human EGFR gene in formalin-fixed paraffin-embedded non-small cell lung cancer (NSCLC) tissue. The US FDA has approved the kit for selecting patients with NSCLC for treatment with afatinib or gefitinib. The test has good analytical sensitivity and specificity. It requires only two 5 µm tissue sections, is easy to use, provides automated interpretation of results and can be performed in <8 h. There is good concordance between EGFR mutation test results obtained with this kit and several other assays. The clinical utility of the kit has been validated in phase 3 or 4 trials in which NSCLC patients with EGFR mutations as detected by the kit had greater clinical benefits with afatinib or gefitinib than with standard chemotherapy.