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Clinical Research (Excluding Clinical Trials)

Abstract 3739: Comparison of technologies for EGFR analysis within a subset of a randomized clinical trial

Mirko Marabese, Massimo Broggini, Martin Reijans, Cedric Gouedard, Geert Maertens, Erwin Sablon, Monica Ganzinelli, Marina C. Garassino and Samuel Murray
Mirko Marabese
Mario Negri Inst. for Pharmacol. Research, Milan, Italy;
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Massimo Broggini
Mario Negri Inst. for Pharmacol. Research, Milan, Italy;
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Martin Reijans
Biocartis, Mechelen, Belgium;
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Cedric Gouedard
BioPath Innovations SA, Athens, Greece;
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Geert Maertens
Biocartis, Mechelen, Belgium;
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Erwin Sablon
Biocartis, Mechelen, Belgium;
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Monica Ganzinelli
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;
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Marina C. Garassino
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;
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Samuel Murray
Biomarker Solutions Ltd, London, United Kingdom.
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DOI: 10.1158/1538-7445.AM2017-3739 Published July 2017
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Proceedings: AACR Annual Meeting 2017; April 1-5, 2017; Washington, DC

Abstract

Background: EGFR mutation analysis is laborious often requiring >5 working days and multiple slices of formalin-fixed paraffin-embedded (FFPE) tissue. Idylla™ is a fully integrated, automated molecular diagnostics platform combining speed, ease of use, high sensitivity, multiplexing capabilities, offering sensitive detection of 52 mutations including insertions and deletions in exons 18-21.

Methods: We assessed 149 cases from the phase III TAILOR study (Garassino et al, Lancet Oncology 2013;14:981-8), where EGFR was centrally assessed. Relative concordance between study entry classification to TAILOR (Sanger sequencing), Idylla™ and next generation sequencing (NGS) for EGFR were investigated. Single unprocessed sections were used per Idylla™ and NGS following pathological review. NGS was performed using the AmpliseqTM Colon and Lung Cancer Panel v2 on an Ion Torrent PGM™ (Thermo Fisher) in a reference laboratory3; Idylla™ (Biocartis NV) was performed at Biocartis1. Samples and study genotypes were blinded to NGS and Idylla™.

Results: There were 132 eligible calls to compare NGS vs Idylla™ (14 fails NGS, 1 Idylla™, 2 both); 108 to compare Sanger vs Idylla™ (38 fails Sanger, 2 Idylla™, 1 both); 101 to compare Sanger vs NGS (31 fails Sanger, 7 NGS, 9 both). For NGS, a minimum coverage of 500 reads was set at a clinically relevant LOD of 5% mutant allelic frequency for calls. Comparison NGS vs Idylla™: 46 EGFR (34.8%) mutation positive by Idylla™, 43 (32.6%) by NGS; Sensitivity 93.48%; Specificity 100.00 %. Comparison Sanger v Idylla™: 41 EGFR (38.0%) mutation positive by Idylla™, 38 (35.2%) by Sanger; Sensitivity 85.37%; Specificity 95.52 %. Sanger v NGS: 39 EGFR (38.6%) mutation positive by NGS, 39 (38.6%) by Sanger; Sensitivity 87.18%; Specificity 91.94 %. Of 16 NGS failures 14 were reportable by Idylla™.

Conclusions: Idylla™ proved to be a reliable platform for rapid EGFR mutational status evaluation. Compared to NGS and Sanger sequencing Idylla™ has several advantages: its ease of use, hands on time <5 mins, all-inclusive lyophilized cartridge requiring only one section of 5μm FFPE, restricted secondary manipulation errors in a busy workflow. Positive and Negative predictive values for both Idylla™ and NGS were excellent. Although NGS offers significant additional clinical data availability through multiplexing, the number of samples classified as inadequate for NGS (14/16 giving result with Idylla™) indicates a likely requirement of more sample robust platforms in diagnostic workflows.

Citation Format: Mirko Marabese, Massimo Broggini, Martin Reijans, Cedric Gouedard, Geert Maertens, Erwin Sablon, Monica Ganzinelli, Marina C. Garassino, Samuel Murray. Comparison of technologies for EGFR analysis within a subset of a randomized clinical trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 3739. doi:10.1158/1538-7445.AM2017-3739

  • ©2017 American Association for Cancer Research.
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Cancer Research: 77 (13 Supplement)
July 2017
Volume 77, Issue 13 Supplement
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Abstract 3739: Comparison of technologies for EGFR analysis within a subset of a randomized clinical trial
Mirko Marabese, Massimo Broggini, Martin Reijans, Cedric Gouedard, Geert Maertens, Erwin Sablon, Monica Ganzinelli, Marina C. Garassino and Samuel Murray
Cancer Res July 1 2017 (77) (13 Supplement) 3739; DOI: 10.1158/1538-7445.AM2017-3739

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Abstract 3739: Comparison of technologies for EGFR analysis within a subset of a randomized clinical trial
Mirko Marabese, Massimo Broggini, Martin Reijans, Cedric Gouedard, Geert Maertens, Erwin Sablon, Monica Ganzinelli, Marina C. Garassino and Samuel Murray
Cancer Res July 1 2017 (77) (13 Supplement) 3739; DOI: 10.1158/1538-7445.AM2017-3739
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Cancer Research Online ISSN: 1538-7445
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