title: Noninvasive saliva-based EGFR gene mutation detection in patients with lung cancer.
abstract: BACKGROUND
  Constitutive activation of the epidermal growth factor receptor (EGFR) is prevalent in epithelial cancers, particularly in non-small cell lung carcinoma (NSCLC). Mutations identified in EGFR predict the sensitivity to EGFR-targeted therapy. Detection of these mutations is mainly based on tissue biopsy, which is invasive, expensive, and time consuming.
  
  
  OBJECTIVE
  Noninvasive, real-time, inexpensive detection and monitoring of EGFR mutations in patients with NSCLC is highly desirable.
  
  
  METHODS
  We developed a novel core technology, electric field-induced release and measurement (EFIRM), which relies on a multiplexible electrochemical sensor that can detect EGFR mutations directly in bodily fluids.
  
  
  RESULTS
  We established EFIRM for the detection of the EGFR mutations in vitro and correlated the results with tumor size from xenografted mice. In clinical application, we demonstrated that EFIRM could detect EGFR mutations in the saliva and plasma of 22 patients with NSCLC. Finally, a blinded test was performed on saliva samples from 40 patients with NSCLC. The receiver operating characteristic analysis indicated that EFIRM detected the exon 19 deletion with an area under the curve of 0.94 and the L858R mutation with an area under the curve of 0.96.
  
  
  CONCLUSIONS
  Our data indicate that EFIRM is effective, accurate, rapid, user-friendly, and cost effective for the detection of EGFR mutations in the saliva of patients with NSCLC. We termed this saliva-based EGFR mutation detection (SABER).
authors.affiliation: 1 School of Dentistry and.
authors.forename: Fang
authors.initials: F
authors.lastname: Wei
authors.forename: Chien-Chung
authors.initials: CC
authors.lastname: Lin
authors.forename: Aron
authors.initials: A
authors.lastname: Joon
authors.forename: Ziding
authors.initials: Z
authors.lastname: Feng
authors.forename: Gabriel
authors.initials: G
authors.lastname: Troche
authors.forename: Maruja E
authors.initials: ME
authors.lastname: Lira
authors.forename: David
authors.initials: D
authors.lastname: Chia
authors.forename: Mao
authors.initials: M
authors.lastname: Mao
authors.forename: Chung-Liang
authors.initials: CL
authors.lastname: Ho
authors.forename: Wu-Chou
authors.initials: WC
authors.lastname: Su
authors.forename: David T W
authors.initials: DT
authors.lastname: Wong
mesh_terms: D000368:Aged; D000818:Animals; D015374:Biosensing Techniques; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000235:genetics*; D004195:Disease Models, Animal; D055664:Electrochemical Techniques; D005260:Female; D018773:Genes, erbB-1 / Q000235:genetics*; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000235:genetics*; D008297:Male; D051379:Mice; D008875:Middle Aged; D009154:Mutation / Q000235:genetics*; D012463:Saliva; D012680:Sensitivity and Specificity; D016037:Single-Blind Method
keywords: EGFR mutation; electrochemical sensor; lung cancer; saliva diagnostics