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Br J Cancer. 2014 Jul 15;111(2):413-20. doi: 10.1038/bjc.2014.353. Epub 2014 Jul 1.

Assessing standardization of molecular testing for non-small-cell lung cancer: results of a worldwide external quality assessment (EQA) scheme for EGFR mutation testing.

Author information

  • 1EMQN, Manchester Centre for Genomic Medicine, St Mary's Hospital, Manchester M13 9WL, UK.
  • 2Cell Biology and Biotherapy Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale'-IRCCS, 80131 Naples, Italy.
  • 3Christie Hospital, Manchester M20 4BX, UK.
  • 4Biomarker Solutions Ltd, London EC1V 2NX, UK.
  • 5Department of Pathology, Aberdeen Royal Infirmary, Aberdeen AB25 2ZN, UK.
  • 6Charité, Humboldt-Universität zu Berlin, Berlin 10117, Germany.
  • 7Medical University of Vienna, 1010 Vienna, Austria.
  • 8Pangaea Biotech, USP Dexeus University Institute, Barcelona 08028, Spain.
  • 9Royal Marsden Hospital, London SW3 6JJ, UK.
  • 10University Hospital Zürich, CH-8091 Zürich, Switzerland.
  • 11Department of Pathology, VU University Medical Center, Amsterdam 1081 HZ, The Netherlands.



The external quality assurance (EQA) process aims at establishing laboratory performance levels. Leading European groups in the fields of EQA, Pathology, and Medical and Thoracic Oncology collaborated in a pilot EQA scheme for somatic epidermal growth factor receptor (EGFR) gene mutational analysis in non-small-cell lung cancer (NSCLC).


EQA samples generated from cell lines mimicking clinical samples were provided to participating laboratories, each with a mock clinical case. Participating laboratories performed the analysis using their usual method(s). Anonymous results were assessed and made available to all participants. Two subsequent EQA rounds followed the pilot scheme.


One hundred and seventeen labs from 30 countries registered and 91 returned results. Sanger sequencing and a commercial kit were the main methodologies used. The standard of genotyping was suboptimal, with a significant number of genotyping errors made. Only 72 out of 91 (72%) participants passed the EQA. False-negative and -positive results were the main sources of error. The quality of reports submitted was acceptable; most were clear, concise and easy to read. However, some participants reported the genotyping result in the absence of any interpretation and many obscured the interpretation required for clinical care.


Even in clinical laboratories, the technical performance of genotyping in EGFR mutation testing for NSCLC can be improved, evident from a high level of diagnostic errors. Robust EQA can contribute to global optimisation of EGFR testing for NSCLC patients.

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