Clinical screening assay for EGFR exon 19 mutations using PNA-clamp smart amplification process version 2 in lung adenocarcinoma

Takuya Araki, Kimihiro Shimizu, Tomonori Nakamura, Masaru Baba, Yuki Kawai, Katsunori Nakamura, Yasumasa Mitani, Kyoko Obayashi, Tohru Aomori, Yukiyoshi Fujita, Yohei Miyamae, Seiichi Kakegawa, Kyoichi Kaira, Alexander Lezhava, Yoshihide Hayashizaki, Izumi Takeyoshi, Koujirou Yamamoto

Research output: Contribution to journalArticlepeer-review

12 Citations (Scopus)


The presence of EGFR mutations is correlated with a positive therapeutic response to tyrosine kinase inhibitors; therefore, the accurate detection of EGFR mutations is crucial when deciding appropriate therapeutic strategies. Recently, the rapid and sensitive assay smart amplification process version 2 (SmartAmp2) was developed. However, this method can only detect one type of mutation in EGFR exon 19; therefore, we applied the PNA technology to the SmartAmp2 assay to develop PNA-clamp SmartAmp2 for the detection of many types of deletions in EGFR exon 19, in a single reaction. This new assay was evaluated using 172 clinical samples. Thirty-nine (22.7%) samples were found to have deletions by PNA-clamp SmartAmp2; whereas 30 (17.4%) and 38 (22.1%) tumors were found to have deletions by direct sequencing and PNA-enriched sequencing, respectively. Three cases, in which we detected mutations with PNA-clamp SmartAmp2, but not with direct sequencing, were treated with gefitinib, and all cases showed a partial therapeutic response. Using clinical samples, we demonstrated that PNA-clamp SmartAmp2 can detect various types of mutations in EGFR exon 19 in a relatively short time and with high sensitivity. This method detected small amounts of mutant DNA and identified patients for whom clinical information was previously unavailable from other tests. This test may contribute to the administration of efficient therapeutic strategies.

Original languageEnglish
Pages (from-to)1213-1219
Number of pages7
JournalOncology reports
Issue number5
Publication statusPublished - 2011 Nov
Externally publishedYes


  • EGFR mutation
  • Non-small cell lung cancer
  • PNA-clamp SmartAmp2

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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