Study concept and design: Kris, Johnson, Kwiatkowski, Iafrate, Wistuba, Franklin, Aronson, Camidge, Khuri, Pao, Ladanyi, Kugler, Minna, Bunn.
Acquisition, analysis, or interpretation of data: Kris, Johnson, Berry, Kwiatkowski, Iafrate, Wistuba, Varella-Garcia, Franklin, Su, Shyr, Camidge, Sequist, Glisson, Khuri, Garon, Pao, Rudin, Schiller, Haura, Socinski, Shirai, Giaccone, Chen, Ladanyi, Kugler, Minna, Bunn.
Drafting of the manuscript: Kris, Johnson, Varella-Garcia, Shyr, Camidge, Pao, Socinski, Shirai, Giaccone, Chen, Kugler, Minna, Bunn.
Critical revision of the manuscript for important intellectual content: Kris, Johnson, Berry, Kwiatkowski, Iafrate, Wistuba, Varella-Garcia, Franklin, Aronson, Su, Camidge, Sequist, Glisson, Khuri, Garon, Pao, Rudin, Schiller, Haura, Giaccone, Ladanyi, Minna, Bunn.
Statistical analysis: Kris, Johnson, Berry, Su, Shyr, Chen.
Obtained funding: Kris, Kwiatkowski, Wistuba, Franklin, Khuri, Pao, Kugler, Bunn.
Administrative, technical, or material support: Kris, Berry, Kwiatkowski, Iafrate, Wistuba, Varella-Garcia, Franklin, Aronson, Camidge, Khuri, Garon, Pao, Rudin, Haura, Socinski, Giaccone, Ladanyi, Kugler, Bunn.
Study supervision: Kris, Kwiatkowski, Iafrate, Varella-Garcia, Franklin, Camidge, Khuri, Rudin, Socinski, Ladanyi, Minna, Bunn.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kris reports consulting for Ariad, AstraZeneca, Bind Biosciences, Boehringer Ingelheim, Chugai Pharma, Clovis, Covidien, Daiichi Sankyo, Esanex, Exelixis, and Genentech; receiving grant funding from Boehringer Ingelheim, the National Lung Cancer Partnership (NLCP), Pfizer, PUMA, and Stand up to Cancer (Massachusetts General Hospital); and receiving payments for lectures from Boehringer Ingelheim, Novartis, Millenium, Pfizer, Roche, China, and Roche, Italy. Dr Johnson reports consulting for AstraZeneca and Genentech; holding patents for EGFR mutation testing as indication for EGFR TKI therapy; and receiving royalties from Dana-Farber Cancer Institute for EGFR mutation testing. Dr Berry reports receiving grant funding from NLCP. Dr Kwiatkowski reports consulting for Novartis. Dr Iafrate reports consulting for Bioreference Labs and Pfizer and receiving royalties from Bioreference Labs for licensed SNaPshot technology. Dr Wistuba reports consulting for Boehringer Ingelheim, GE, Genentech/Roche, GlaxoSmithKline, Novartis, Roche, Pfizer, and Ventana; receiving grant funding from AstraZeneca, Bayer, Genentech, Merck, Myriad, and Pfizer; receiving lecture payments from Boehringer Ingelheim and Medscape; and receiving payments for developing educational presentations from Pfizer. Dr Varella-Garcia reports receiving honoraria, research funding, and payments for developing educational presentations from Abbott Molecular. Mr Aronson reports receiving grant funding from the Lung Cancer Mutation Consortium to her institution; receiving lecture fees from Leerink Swann; his institution, Partners HealthCare, licensed the GeneInsight technology in November 2012 to a company in which it acquired 100% equity ownership. This transaction was reviewed by the Partners Committee on Conflicts of Interest in light of Partners acquisition of this financial interest, and the Committee, consistent with Partners policy, required that notice of Partners financial interest in the technology be provided to journals and in publications and presentations on the technology. Partners established a partnership with Illumina related to the GeneInsight software that was in effect during this work. Dr Sequist reports consulting for AstraZeneca, Boehringer Ingelheim, Clovis Oncology, GlaxoSmithKline, and Merrimack Pharmaceuticals. Dr Garon reports consulting for Boehringer Ingelheim and receiving grant funding from AstraZeneca, Eli Lilly, Genentech, Novartis, Pfizer, and Puma Biotechnology. Dr Pao reports consulting for AstraZeneca, Bristol-Myers Squibb, Champions, Clarient, Clovis Oncology, Evolution, Exelixis, MolecularMD, and Symphony; receiving research funding from AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, Enzon, Symphogen, and Xcovery; receiving payment for the development of educational presentations for the International Association for the Study of Lung Cancer and WebMD; serving on panels and as a grant reviewer for the American Association for Cancer Research, Uniting Against Lung Cancer, the American Society of Clinical Oncology, and the National Comprehensive Cancer Network; and receiving remuneration and patent royalties from rights to EGFR T790M testing was licensed on behalf of himself and others by Memorial Sloan Kettering Cancer Center to MolecularMD. Dr Rudin reports consulting for Celgene and Oncothyreon. Dr Schiller reports consulting for AdventRX, Aggenix, Ariad, Arquile, AVEO, Biodesix, Boehringer Ingelheim, Clovis, Dekkun, EMD Serono, Genentech, GlaxoSmithKline, Merck, Novartis, Peregrine, Pfizer, Synta, and Threshold Pharmaceuticals; and receiving grant funding from Astex, Endocyte, Genentech, Geron, Merrimack, Novartis, and Synta. Dr Shirai reports receiving lecture fees from Bristol-Myers Squibb. Dr Ladanyi reports consulting for NanoString, Novartis, Puma Biotechnology and receiving lecture payments from Remedica Medical Education. Dr Minna reports consulting for Amgen; receiving royalties from the National Institutes of Health (NIH) and Genentech for the licensing of lung cancer cell lines; serving on the grant review board of the V Foundation; receiving travel and accommodations from the International Association for the Study of Lung Cancer; and holding NIH grants related to lung cancer. Dr Bunn reports consulting for Amgen, Astellas Pharma, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Eisai, Eli Lilly, GlaxoSmithKline, Merck, Merck Serono, Merrimack, Myriad Genetics, Pfizer, Roche/Genentech, sanofi-aventis, and Synta. No other disclosures are reported.
Funding/Support: This study was entirely supported by a grant from the National Institutes of Health, National Cancer Institute (HSS NIH NCI 1RC2CA148394-010).
Role of the Sponsor: The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Previous Presentation: Presented in part at the 41st annual meeting of the American Society of Clinical Oncology; May 31, 2013, to June 4, 2013; Chicago, Illinois.