Electric Field–Induced Release and Measurement Liquid Biopsy for Noninvasive Early Lung Cancer Assessment

Fang Wei, Charles M. Strom, Jordan Cheng, Chien Chung Lin, Ching Yun Hsu, Guy W. Soo Hoo, David Chia, Yong Kim, Feng Li, David Elashoff, Tristan Grognan, Michael Tu, Wei Liao, Rena Xian, Wayne W. Grody, Wu Chou Su, David T.W. Wong

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8 Citations (Scopus)

Abstract

Previously, we detected circulating tumor DNA that contained two EGFR mutations (p.L858R and exon19 del) in plasma of patients with late-stage non–small-cell lung carcinoma (NSCLC) using the electric field–induced release and measurement (EFIRM) platform. Our aim was to determine whether EFIRM technology can detect these mutations in patients with early-stage NSCLC. Prospectively, 248 patients with radiographically determined pulmonary nodules were recruited. Plasma was collected before biopsy and histologic examination of the nodule. Inclusion criteria were histologic diagnosis of benign nodule (control) and stage I or II adenocarcinoma harboring either p.L858R or exon19 del EGFR mutations. Plasma samples were available from 44 patients: 23 with biopsy-proven benign pulmonary nodules and 21 with stage I or II adenocarcinoma (12 p.L858R and 9 exon19 del EGFR variants). Samples were analyzed for the EGFR mutations using the EFIRM platform. Assay sensitivity was 92% for p.L858R (11 of 12 samples positive) and 77% for exon19 del (7 of 9 samples positive). Specificity was 91% with two false-positive results in 23 patients with EGFR-positive nodules and 95% for the entire 44-patient series. Concordance was 100% with identical mutations discovered in plasma and nodule biopsy. The EFIRM platform is able to noninvasively detect two EGFR mutations in individuals with early-stage NSCLC.

Original languageEnglish
Pages (from-to)738-742
Number of pages5
JournalJournal of Molecular Diagnostics
Volume20
Issue number6
DOIs
Publication statusPublished - 2018 Nov

All Science Journal Classification (ASJC) codes

  • Pathology and Forensic Medicine
  • Molecular Medicine

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    Wei, F., Strom, C. M., Cheng, J., Lin, C. C., Hsu, C. Y., Soo Hoo, G. W., Chia, D., Kim, Y., Li, F., Elashoff, D., Grognan, T., Tu, M., Liao, W., Xian, R., Grody, W. W., Su, W. C., & Wong, D. T. W. (2018). Electric Field–Induced Release and Measurement Liquid Biopsy for Noninvasive Early Lung Cancer Assessment. Journal of Molecular Diagnostics, 20(6), 738-742. https://doi.org/10.1016/j.jmoldx.2018.06.008