|Title:||Profile of the therascreen (R) EGFR RGQ PCR kit as a companion diagnostic for gefitinib in non-small cell lung cancer||Authors:||Hsiue, Emily Han-Chung
Yang, James Chih-Hsin
|Keywords:||EGFR;non-small cell lung cancer;gefitinib;Scorpions;amplification refractory mutation system||Issue Date:||2016||Journal Volume:||16||Journal Issue:||12||Start page/Pages:||1251-1257||Source:||Expert Rev. Mol. Diagn.||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 (R) 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 (R) kit, and the clinical utility of the assay in phase 3 and phase 4 clinical trials. Studies that compared the performance of the therascreen (R) kit with other assays and assessed the kit's application in non-tissue samples are also discussed. ;Expert commentary: The therascreen (R) 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 nontissue samples.
|Appears in Collections:||腫瘤醫學研究所|
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