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.

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.

The Journal of molecular diagnostics : JMD. 2016 Jan 02 [Epub]

Elisabeth M C Dequeker, Cleo Keppens, Caroline Egele, Sofie Delen, Aude Lamy, Antoinette Lemoine, Jean-Christophe Sabourin, Catherine Andrieu, Marjolijn Ligtenberg, Dominique Fetique, Bastiaan Tops, Clotilde Descarpentries, Hélène Blons, Yves Denoux, Cécile Aube, Frederique Penault-Llorca, Paul Hofman, Karen Leroy, Cédric Le Marechal, Laurent Doucet, Valérie Duranton-Tanneur, Florence Pedeutour, Isabelle Soubeyran, Jean-François Côté, Jean-François Emile, Jean-Michel Vignaud, Nathalie Monhoven, Véronique Haddad, Pierre Laurent-Puig, Han van Krieken, Frederique Nowak, Etienne Lonchamp, Jean-Pierre Bellocq, Etienne Rouleau

Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, KU Leuven-University of Leuven, Leuven, Belgium. Electronic address: This email address is being protected from spambots. You need JavaScript enabled to view it.., Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, KU Leuven-University of Leuven, Leuven, Belgium., French Association of Quality Assurance in Pathology (AFAQAP), Hospital d'Hautepierre, Strasbourg, France., Laboratory of Somatic Tumor Genetics, Hospital Charles Nicolle, Rouen, France., Department of Somatic Genetics, Hospital Paul Brousse, Villejuif, France., Unit of Constitutional and Somatic Genetics, Genetics Department, Institut Curie, Paris, France., Department of Pathology, Radboud University Medical Center, Nijmegen, the Netherlands., Molecular Biology Cancer Platform from the region Nord Pas de Calais, Lille, France., Biochemistry Unit, Department of Biology, European Hospital Georges Pompidou, Paris, France., Department of Pathology, Foch Hospital, Suresnes, France., Molecular Pathology Unit, Department of Biopathology, Center Jean Perrin, Clermont-Ferrand, France., Laboratories of Clinical and Experimental Pathology, Pasteur Hospital, CHU de Nice, Nice, France., Department of Pathology, Hospital Henri Mondor, Creteil, France., Laboratory of Anatomical Pathology, Molecular Genetics and Histocompatibility, Platform of Molecular Cancer Genetics, CHRU Brest, Brest, France., Solid Tumor Genetics, Pasteur Hospital, CHU de Nice, Nice, France., Molecular Pathology Unit, Institute Bergonié, Bordeaux, France., Laboratory of Anatomical Pathology, Hospital Tenon, Paris, France., Department of Pathology, Hospital Ambroise Paré, Boulogne-Billancourts, France., Laboratory of Anatomical Pathology, CHU Nancy-Central Hospital, Nancy, France., Laboratory of Molecular Biology, Department of Biopathology, Center Léon Bérard, Lyon, France., National Cancer Institute (INCa), Boulogne-Billancourt, France.