(. Espqa-foundation, . Brussels, ). Belgium, . Prof, . Dr et al., The Netherlands) for the discussion and reviewing of the manuscript

E. ?-we-thank, S. Hombroeckx, and . Sterck, ) for the administrative and coordination support, Biomedical Quality Assurance Research Unit

. ?-we-thank-i and . Marondel, ) for proofreading the manuscript

N. Conflicts-of-interest-'t-hart, Bubendorf L: Consulting fees and speaker honoraria from Abbott, Pfizer, Roche and Astra Zeneca. Dequeker E: An unrestricted research grant was obtained from Pfizer Oncology. Keppens C: No conflict of interests to be declared

B. Astrazeneca, . Meyers-squib, B. Merck, R. Ingelheim, and P. Oncology, Schuuring E: Consulting fees and speaker honoraria from Abbott

L. Tembuyser, Tornillo L: No conflict of interest to be declared, No conflict of interests to be declared

N. Saijo, Critical comments for roles of biomarkers in the diagnosis and treatment of cancer, Cancer Treat Rev, vol.38, pp.63-67, 2012.

E. Thunnissen, K. Van-der-oord, and M. Bakker, Prognostic and predictive biomarkers in lung cancer. A review, Virchows Arch, vol.464, pp.347-58, 2014.

N. I. Lindeman, P. T. Cagle, M. B. Beasley, D. A. Chitale, S. Dacic et al., Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology, J Thorac Oncol, vol.8, pp.823-59, 2013.

A. T. Shaw, S. H. Ou, Y. J. Bang, D. R. Camidge, B. J. Solomon et al., Crizotinib in ROS1-rearranged non-small-cell lung cancer, N Engl J Med, vol.371, pp.1963-71, 2014.

, Xalkori: EPAR summary for the public, European Medicine Agency (EMA), p.27, 2012.

, Xalkori prescribing information, Food and Drug Administration (FDA), 2013.

B. W. Stuart and C. P. Wild, World Cancer Report, World Health Organization (WHO), Non-Series-Publications/ World-Cancer-Reports/World-Cancer, 2014.

L. Tembuyser and E. M. Dequeker, Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers, Virchows Arch, vol.468, pp.31-41, 2016.

P. T. Cagle, T. C. Allen, and R. J. Olsen, Lung cancer biomarkers: present status and future developments, Arch Pathol Lab Med, vol.137, pp.1191-98, 2013.

C. P. O'brien, S. E. Taylor, J. J. O'leary, and S. P. Finn, Molecular testing in oncology: problems, pitfalls and progress, Lung Cancer, vol.83, pp.309-324, 2014.

H. J. Dubbink, Z. C. Deans, B. B. Tops, F. J. Van-kemenade, S. Koljenovi? et al., Next generation diagnostic molecular pathology: critical appraisal of quality assurance in Europe

, Mol Oncol, vol.8, pp.830-869, 2014.

M. Salto-tellez, G. De-castro, and D. , Next-generation sequencing: a change of paradigm in molecular diagnostic validation, J Pathol, vol.234, pp.5-10, 2014.

V. Tack, M. J. Ligtenberg, L. Tembuyser, N. Normanno, V. Borght et al., External quality assessment unravels interlaboratory differences in quality of RAS testing for anti-EGFR therapy in colorectal cancer, Oncologist, vol.20, pp.257-62, 2015.

J. H. Van-krieken, N. Normanno, F. Blackhall, E. Boone, G. Botti et al., Guideline on the requirements of external quality assessment programs in molecular pathology, Virchows Arch, vol.462, pp.27-37, 2013.

, International Organization for Standardization. ISO 15189:2012 Medical laboratories -Particular requirements for quality and competence, 2012.

, Clinical Laboratory Improvement Amendments of. 1988, 42 U.S.C. 263a PL100-578, Laboratory Requirements, p.42, 1988.

L. Tembuyser, V. Tack, K. Zwaenepoel, P. Pauwels, K. Miller et al., The relevance of external quality assessment for molecular testing for ALK positive non-small cell lung cancer: results from two pilot rounds show room for optimization, PLoS One, vol.9, 2014.

E. Thunnissen, L. Bubendorf, M. Dietel, G. Elmberger, K. Kerr et al., EML4-ALK testing in non-small cell carcinomas of the lung: a review with recommendations, Virchows Arch, vol.461, pp.245-57, 2012.

D. R. Camidge, S. A. Kono, A. Flacco, A. C. Tan, R. C. Doebele et al., Optimizing the detection of lung cancer patients harboring anaplastic lymphoma kinase (ALK) gene rearrangements potentially suitable for ALK inhibitor treatment, Clin Cancer Res, vol.16, pp.5581-90, 2010.

A. Vysis and A. Kit, , 2017.

S. Patton, N. Normanno, F. Blackhall, S. Murray, K. M. Kerr et al., Assessing standardization of molecular testing for non-small-cell lung cancer: results of a worldwide external quality assessment (EQA) scheme for EGFR mutation testing, Br J Cancer, vol.111, pp.413-433, 2014.

Z. C. Deans, N. Bilbe, B. O'sullivan, L. P. Lazarou, D. G. De-castro et al., Improvement in the quality of molecular analysis of EGFR in non-small-cell lung cancer detected by three rounds of external quality assessment, J Clin Pathol, vol.66, pp.319-344, 2013.

N. Normanno, C. Pinto, G. Taddei, M. Gambacorta, F. Castiglione et al., Results of the First Italian External Quality Assurance Scheme for somatic EGFR mutation testing in non-small-cell www.oncotarget.com lung cancer, J Thorac Oncol, vol.8, pp.773-781, 2013.

E. M. Dequeker, C. Keppens, C. Egele, S. Delen, A. Lamy et al., Three Rounds of External Quality Assessment in France to Evaluate the Performance of 28 Platforms for Multiparametric Molecular Testing in Metastatic Colorectal and Non-Small Cell Lung Cancer, J Mol Diagn, vol.18, pp.205-219, 2016.
URL : https://hal.archives-ouvertes.fr/hal-01666600

M. V-laffert, A. Warth, R. Penzel, P. Schirmacher, D. Jonigk et al., Anaplastic lymphoma kinase (ALK) gene rearrangement in nonsmall cell lung cancer (NSCLC): results of a multi-centre ALK-testing, Lung Cancer, vol.81, pp.200-206, 2013.

, Conformity assessment -General requirements for proficiency testing, International Organization for Standardization. ISO, vol.17043, 2010.

I. A. Cree, Z. Deans, M. J. Ligtenberg, N. Normanno, A. Edsjö et al., and European Society of Pathology Task Force on Quality Assurance in Molecular Pathology, and Royal College of Pathologists. Guidance for laboratories performing molecular pathology for cancer patients, J Clin Pathol, vol.67, pp.923-954, 2014.

W. Pao, V. A. Miller, K. A. Politi, G. J. Riely, R. Somwar et al., Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain

, PLoS Med, vol.2, 2005.

. Osimertinib, Food and Drug Administration (FDA), 2017.

. Tagrisso, EPAR summary for the public, European Medicines Agency (EMA), 2015.

M. S. Tsao, F. Hirsch, and Y. Yatabe, IASLC atlas of ALK and ROS1 testing in lung cancer, 2016.

C. M. Conklin, K. J. Craddock, C. Have, J. Laskin, C. Couture et al., Immunohistochemistry is a reliable screening tool for identification of ALK rearrangement in nonsmall-cell lung carcinoma and is antibody dependent, J Thorac Oncol, vol.8, pp.45-51, 2013.

K. Zwaenepoel, A. Van-dongen, S. Lambin, C. Weyn, and P. Pauwels, Detection of ALK expression in non-small-cell lung cancer with ALK gene rearrangements-comparison of multiple immunohistochemical methods, Histopathology, vol.65, pp.539-587, 2014.

Q. Wang, L. Zhao, X. Yang, S. Wei, Y. Zeng et al., Antibody 1A4 with routine immunohistochemistry demonstrates high sensitivity for ALK rearrangement screening of Chinese lung adenocarcinoma patients: A single-center large-scale study, Lung Cancer, vol.95, pp.39-43, 2016.

M. Ibrahim, S. Parry, D. Wilkinson, N. Bilbe, A. D. Forrest et al., ALK Immunohistochemistry in NSCLC: Discordant Staining Can Impact Patient Treatment Regimen, J Thorac Oncol, vol.11, pp.2241-2288, 2016.

L. Bubendorf, R. Büttner, F. Al-dayel, M. Dietel, G. Elmberger et al., Testing for ROS1 in non-small cell lung cancer: a review with recommendations, Virchows Arch, vol.469, pp.489-503, 2016.

L. Mescam-mancini, S. Lantuéjoul, D. Moro-sibilot, I. Rouquette, P. J. Souquet et al., On the relevance of a testing algorithm for the detection of ROS1-rearranged lung adenocarcinomas, Lung Cancer, vol.83, pp.168-73, 2014.