title: Profile of the therascreen® EGFR RGQ PCR kit as a companion diagnostic for gefitinib in non-small cell lung cancer.
abstract: Gefitinib is recently approved by the US Food and Drug Administration as a first-line treatment for non-small cell lung cancer (NSCLC) patients harboring EGFR mutations. The therascreen® EGFR RGQ PCR Kit is approved as a companion diagnostic to select patients with EGFR exon 19 deletions and L858R mutation for treatment with gefitinib. Areas covered: This article reviews the methods for detecting EGFR mutations, the technology and indication of the therascreen® kit, and the clinical utility of the assay in phase 3 and phase 4 clinical trials. Studies that compared the performance of the therascreen® kit with other assays and assessed the kit's application in non-tissue samples are also discussed. Expert commentary: The therascreen® kit is a highly sensitive real-time polymerase chain reaction test that provides standardised testing and automated interpretation of EGFR mutation status in formalin-fixed, paraffin-embedded (FFPE) tissue samples. Although not indicated for these applications, the test has also shown utility in detecting uncommon sensitizing EGFR mutations as well as mutations in non-tissue samples.
authors.affiliation: a Department of Oncology , National Taiwan University Hospital , Taipei , Taiwan.
authors.forename: Emily Han-Chung
authors.initials: EH
authors.lastname: Hsiue
authors.affiliation: a Department of Oncology , National Taiwan University Hospital , Taipei , Taiwan.|b Department of Medical Research , National Taiwan University Hospital , Taipei , Taiwan.|c Graduate Institute of Oncology , National Taiwan University College of Medicine , Taipei , Taiwan.|d National Taiwan University Cancer Center , Taipei , Taiwan.
authors.forename: Jih-Hsiang
authors.initials: JH
authors.lastname: Lee
authors.affiliation: a Department of Oncology , National Taiwan University Hospital , Taipei , Taiwan.|c Graduate Institute of Oncology , National Taiwan University College of Medicine , Taipei , Taiwan.|d National Taiwan University Cancer Center , Taipei , Taiwan.|e Department of Urology , National Taiwan University Hospital , Taipei , Taiwan.
authors.forename: Chia-Chi
authors.initials: CC
authors.lastname: Lin
authors.affiliation: a Department of Oncology , National Taiwan University Hospital , Taipei , Taiwan.|b Department of Medical Research , National Taiwan University Hospital , Taipei , Taiwan.|c Graduate Institute of Oncology , National Taiwan University College of Medicine , Taipei , Taiwan.|d National Taiwan University Cancer Center , Taipei , Taiwan.
authors.forename: James Chih-Hsin
authors.initials: JC
authors.lastname: Yang
mesh_terms: D014408:Biomarkers, Tumor; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics*; D004252:DNA Mutational Analysis / Q000379:methods* / Q000592:standards; D004273:DNA, Neoplasm / Q000097:blood; D066246:ErbB Receptors / Q000235:genetics*; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics*; D009154:Mutation; D016066:Pleural Effusion, Malignant / Q000473:pathology; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011799:Quinazolines / Q000627:therapeutic use; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D012680:Sensitivity and Specificity; D017422:Sequence Analysis, DNA
chemical_list: D014408:Biomarkers, Tumor; D004273:DNA, Neoplasm; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D011933:Reagent Kits, Diagnostic; D066246:ErbB Receptors; D000077156:Gefitinib
keywords: EGFR; Scorpions; amplification refractory mutation system; gefitinib; non-small cell lung cancer