Comparison of the analytical performance between cobas EGFR assay and PCR-clamp method in the detection of EGFR mutations in Japanese non-small cell lung cancer patients

Tomohiko Ai, Maiko Yuri, Yoko Tabe, Atsushi Kakimoto, Soji Morishita, Koji Tsuchiya, Kazuya Takamochi, Yuzo Kodama, Fumiyuki Takahashi, Misawa Shigeki, Takashi Horii, Kenji Suzuki, Kazuhisa Takahashi, Takashi Miida, Akimichi Ohsaka

Research output: Contribution to journalArticle

Abstract

Background: EGFR, a tyrosine-kinase, plays an important role in the progression of lung cancer. Since genetic abnormality of EGFR alters the effects of tyrosine-kinase inhibitors targeting EGFR, molecular analyses of EGFR have recently gained more attention in the treatment of lung cancer. However, several different techniques are available and which method is superior has not been determined. In this study, we compared two recently developed PCR-based techniques, PCR-clamp method and cobas EGFR assay. Methods: Ninety-four surgical samples and 58 biopsy samples from patients suffering from non-small cell lung cancers (NSCLCs) were included in the study. Samples with positive and negative genetic abnormalities, 66 and 28 respectively, were chosen for PCR-Clamp methods. Those same samples were reanalyzed with cobas EGFR assay. Results: The concordance between PCR-Clamp and cobas EGFR methods was 95.7%. PCR-Clamp failed to detect four mutations that were detected with cobas EGFR assay. These two methods were further tested by analyzing 58 random biopsy samples. The concordance for the biopsy samples was 93.1%, and PCR-Clamp, again, failed to detect three mutations that were detected with cobas EGFR assay. Conclusions: Our results showed both methods detected most of the known EGFR mutations and the concordance was similar to those previously reported in different ethnicities. However, in our study, PCR-Clamp method failed to detect a total of seven mutations that were detected with cobas EGFR assay. Thus, we concluded that cobas EGFR assay is an easier and more accurate screening assay than PCR-Clamp method in detecting EGFR genetic abnormalities.

Original languageEnglish (US)
Pages (from-to)1021-1026
Number of pages6
JournalClinical Laboratory
Volume63
Issue number5-6
DOIs
StatePublished - Jan 1 2017
Externally publishedYes

Fingerprint

Clamping devices
Non-Small Cell Lung Carcinoma
Assays
Cells
Polymerase Chain Reaction
Mutation
Biopsy
Protein-Tyrosine Kinases
Lung Neoplasms
Screening

Keywords

  • Automated hematology analyzer
  • EGFR
  • Lung cancer
  • PCR

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

Comparison of the analytical performance between cobas EGFR assay and PCR-clamp method in the detection of EGFR mutations in Japanese non-small cell lung cancer patients. / Ai, Tomohiko; Yuri, Maiko; Tabe, Yoko; Kakimoto, Atsushi; Morishita, Soji; Tsuchiya, Koji; Takamochi, Kazuya; Kodama, Yuzo; Takahashi, Fumiyuki; Shigeki, Misawa; Horii, Takashi; Suzuki, Kenji; Takahashi, Kazuhisa; Miida, Takashi; Ohsaka, Akimichi.

In: Clinical Laboratory, Vol. 63, No. 5-6, 01.01.2017, p. 1021-1026.

Research output: Contribution to journalArticle

Ai, T, Yuri, M, Tabe, Y, Kakimoto, A, Morishita, S, Tsuchiya, K, Takamochi, K, Kodama, Y, Takahashi, F, Shigeki, M, Horii, T, Suzuki, K, Takahashi, K, Miida, T & Ohsaka, A 2017, 'Comparison of the analytical performance between cobas EGFR assay and PCR-clamp method in the detection of EGFR mutations in Japanese non-small cell lung cancer patients', Clinical Laboratory, vol. 63, no. 5-6, pp. 1021-1026. https://doi.org/10.7754/Clin.Lab.2017.161223
Ai, Tomohiko ; Yuri, Maiko ; Tabe, Yoko ; Kakimoto, Atsushi ; Morishita, Soji ; Tsuchiya, Koji ; Takamochi, Kazuya ; Kodama, Yuzo ; Takahashi, Fumiyuki ; Shigeki, Misawa ; Horii, Takashi ; Suzuki, Kenji ; Takahashi, Kazuhisa ; Miida, Takashi ; Ohsaka, Akimichi. / Comparison of the analytical performance between cobas EGFR assay and PCR-clamp method in the detection of EGFR mutations in Japanese non-small cell lung cancer patients. In: Clinical Laboratory. 2017 ; Vol. 63, No. 5-6. pp. 1021-1026.
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abstract = "Background: EGFR, a tyrosine-kinase, plays an important role in the progression of lung cancer. Since genetic abnormality of EGFR alters the effects of tyrosine-kinase inhibitors targeting EGFR, molecular analyses of EGFR have recently gained more attention in the treatment of lung cancer. However, several different techniques are available and which method is superior has not been determined. In this study, we compared two recently developed PCR-based techniques, PCR-clamp method and cobas EGFR assay. Methods: Ninety-four surgical samples and 58 biopsy samples from patients suffering from non-small cell lung cancers (NSCLCs) were included in the study. Samples with positive and negative genetic abnormalities, 66 and 28 respectively, were chosen for PCR-Clamp methods. Those same samples were reanalyzed with cobas EGFR assay. Results: The concordance between PCR-Clamp and cobas EGFR methods was 95.7{\%}. PCR-Clamp failed to detect four mutations that were detected with cobas EGFR assay. These two methods were further tested by analyzing 58 random biopsy samples. The concordance for the biopsy samples was 93.1{\%}, and PCR-Clamp, again, failed to detect three mutations that were detected with cobas EGFR assay. Conclusions: Our results showed both methods detected most of the known EGFR mutations and the concordance was similar to those previously reported in different ethnicities. However, in our study, PCR-Clamp method failed to detect a total of seven mutations that were detected with cobas EGFR assay. Thus, we concluded that cobas EGFR assay is an easier and more accurate screening assay than PCR-Clamp method in detecting EGFR genetic abnormalities.",
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AU - Tabe, Yoko

AU - Kakimoto, Atsushi

AU - Morishita, Soji

AU - Tsuchiya, Koji

AU - Takamochi, Kazuya

AU - Kodama, Yuzo

AU - Takahashi, Fumiyuki

AU - Shigeki, Misawa

AU - Horii, Takashi

AU - Suzuki, Kenji

AU - Takahashi, Kazuhisa

AU - Miida, Takashi

AU - Ohsaka, Akimichi

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N2 - Background: EGFR, a tyrosine-kinase, plays an important role in the progression of lung cancer. Since genetic abnormality of EGFR alters the effects of tyrosine-kinase inhibitors targeting EGFR, molecular analyses of EGFR have recently gained more attention in the treatment of lung cancer. However, several different techniques are available and which method is superior has not been determined. In this study, we compared two recently developed PCR-based techniques, PCR-clamp method and cobas EGFR assay. Methods: Ninety-four surgical samples and 58 biopsy samples from patients suffering from non-small cell lung cancers (NSCLCs) were included in the study. Samples with positive and negative genetic abnormalities, 66 and 28 respectively, were chosen for PCR-Clamp methods. Those same samples were reanalyzed with cobas EGFR assay. Results: The concordance between PCR-Clamp and cobas EGFR methods was 95.7%. PCR-Clamp failed to detect four mutations that were detected with cobas EGFR assay. These two methods were further tested by analyzing 58 random biopsy samples. The concordance for the biopsy samples was 93.1%, and PCR-Clamp, again, failed to detect three mutations that were detected with cobas EGFR assay. Conclusions: Our results showed both methods detected most of the known EGFR mutations and the concordance was similar to those previously reported in different ethnicities. However, in our study, PCR-Clamp method failed to detect a total of seven mutations that were detected with cobas EGFR assay. Thus, we concluded that cobas EGFR assay is an easier and more accurate screening assay than PCR-Clamp method in detecting EGFR genetic abnormalities.

AB - Background: EGFR, a tyrosine-kinase, plays an important role in the progression of lung cancer. Since genetic abnormality of EGFR alters the effects of tyrosine-kinase inhibitors targeting EGFR, molecular analyses of EGFR have recently gained more attention in the treatment of lung cancer. However, several different techniques are available and which method is superior has not been determined. In this study, we compared two recently developed PCR-based techniques, PCR-clamp method and cobas EGFR assay. Methods: Ninety-four surgical samples and 58 biopsy samples from patients suffering from non-small cell lung cancers (NSCLCs) were included in the study. Samples with positive and negative genetic abnormalities, 66 and 28 respectively, were chosen for PCR-Clamp methods. Those same samples were reanalyzed with cobas EGFR assay. Results: The concordance between PCR-Clamp and cobas EGFR methods was 95.7%. PCR-Clamp failed to detect four mutations that were detected with cobas EGFR assay. These two methods were further tested by analyzing 58 random biopsy samples. The concordance for the biopsy samples was 93.1%, and PCR-Clamp, again, failed to detect three mutations that were detected with cobas EGFR assay. Conclusions: Our results showed both methods detected most of the known EGFR mutations and the concordance was similar to those previously reported in different ethnicities. However, in our study, PCR-Clamp method failed to detect a total of seven mutations that were detected with cobas EGFR assay. Thus, we concluded that cobas EGFR assay is an easier and more accurate screening assay than PCR-Clamp method in detecting EGFR genetic abnormalities.

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