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

Elisabeth M.C. Dequeker 1 Cleo Keppens 1 Caroline Egelé 2 Sofie Delen 1 Aude Lamy 3 Antoinette Lemoine 4 Jean-Christophe Sabourin 3 Catherine Andrieu 5 Marjolijn Ligtenberg 6 Dominique Fetique 2 Bastiaan Tops 6 Clotilde Descarpentries Hélène Blons 7 Yves Denoux 8 Cécile Aube 9 Frédérique Penault-Llorca 9 Paul Hofman 10 Karen Leroy 11 Cédric Le Marechal 12 Laurent Doucet 12 Valérie Duranton-Tanneur 13 Florence Pedeutour 13 Isabelle Soubeyran 14 Jean-François Côté 15 Jean-François Emile 16 Jean-Michel Vignaud 17, 18 Nathalie Monhoven 17, 18 Véronique Haddad 19 Pierre Laurent-Puig 7 Han Van Krieken 6 Frédérique Nowak 20 Etienne Lonchamp 20 Jean-Pierre Bellocq 21 Etienne Rouleau 22
Abstract : Personalized medicine has gained increasing importance in clinical oncology, and several clinically important biomarkers are implemented in routine practice. In an effort to guarantee high quality of molecular testing in France, three subsequent external quality assessment rounds were organized at the initiative of the National Cancer Institute between 2012 and 2014. The schemes included clinically relevant biomarkers for metastatic colorectal (KRAS, NRAS, BRAF, PIK3CA, microsatellite instability) and non-small cell lung cancer (EGFR, KRAS, BRAF, PIK3CA, ERBB2), and they represent the first multigene/multicancer studies throughout Europe. In total, 56 laboratories coordinated by 28 regional molecular centers participated in the schemes. Laboratories received formalin-fixed, paraffin-embedded samples and were asked to use routine methods for molecular testing to predict patient response to targeted therapies. They were encouraged to return results within 14 calendar days after sample receipt. Both genotyping and reporting were evaluated separately. During the three external quality assessment rounds, mean genotype scores were all above the preset standard of 90% for all biomarkers. Participants were mainly challenged in case of rare insertions or deletions. Assessment of the written reports showed substantial progress between the external quality assessment schemes on multiple criteria. Several essential elements such as the clinical interpretation of test results and the reason for testing still require improvement by continued external quality assessment education.
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The Journal of Molecular Diagnostics, Elsever, 2016, 18 (2), pp.205 - 214. 〈10.1016/j.jmoldx.2015.09.004〉
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Elisabeth M.C. Dequeker, Cleo Keppens, Caroline Egelé, Sofie Delen, Aude 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. The Journal of Molecular Diagnostics, Elsever, 2016, 18 (2), pp.205 - 214. 〈10.1016/j.jmoldx.2015.09.004〉. 〈hal-01666600〉

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