Profile of the therascreen® EGFR RGQ PCR kit as a companion diagnostic for gefitinib in non-small cell lung cancer.

Abstract

INTRODUCTION:

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: Emily Han-Chung Hsiue, Jih-Hsiang Lee, Chia-Chi Lin, James Chih-Hsin Yang
• Journal: Expert review of molecular diagnostics (Expert Rev Mol Diagn) Vol. 16 Issue 12 Pg. 1251-1257 (12 2016) ISSN: 1744-8352 [Electronic] England
• PMID: 27737606 (Publication Type: Journal Article, Review)

Chemical References

• Biomarkers, Tumor
• DNA, Neoplasm
• Protein Kinase Inhibitors
• Quinazolines
• Reagent Kits, Diagnostic
• ErbB Receptors
• Gefitinib

Topics

• Biomarkers, Tumor
• Carcinoma, Non-Small-Cell Lung (diagnosis, drug therapy, genetics)
• DNA Mutational Analysis (methods, standards)
• DNA, Neoplasm (blood)
• ErbB Receptors (genetics)
• Gefitinib
• Humans
• Lung Neoplasms (diagnosis, drug therapy, genetics)
• Mutation
• Pleural Effusion, Malignant (pathology)
• Protein Kinase Inhibitors (therapeutic use)
• Quinazolines (therapeutic use)
• Reagent Kits, Diagnostic
• Real-Time Polymerase Chain Reaction (methods, standards)
• Sensitivity and Specificity
• Sequence Analysis, DNA