title: 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.
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.
authors.affiliation: Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, KU Leuven-University of Leuven, Leuven, Belgium. Electronic address: els.dequeker@med.kuleuven.be.
authors.forename: Elisabeth M C
authors.initials: EM
authors.lastname: Dequeker
authors.affiliation: Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, KU Leuven-University of Leuven, Leuven, Belgium.
authors.forename: Cleo
authors.initials: C
authors.lastname: Keppens
authors.affiliation: French Association of Quality Assurance in Pathology (AFAQAP), Hospital d'Hautepierre, Strasbourg, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Egele
authors.affiliation: Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, KU Leuven-University of Leuven, Leuven, Belgium.
authors.forename: Sofie
authors.initials: S
authors.lastname: Delen
authors.affiliation: Laboratory of Somatic Tumor Genetics, Hospital Charles Nicolle, Rouen, France.
authors.forename: Aude
authors.initials: A
authors.lastname: Lamy
authors.affiliation: Department of Somatic Genetics, Hospital Paul Brousse, Villejuif, France.
authors.forename: Antoinette
authors.initials: A
authors.lastname: Lemoine
authors.affiliation: Laboratory of Somatic Tumor Genetics, Hospital Charles Nicolle, Rouen, France.
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Sabourin
authors.affiliation: Unit of Constitutional and Somatic Genetics, Genetics Department, Institut Curie, Paris, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Andrieu
authors.affiliation: Department of Pathology, Radboud University Medical Center, Nijmegen, the Netherlands.
authors.forename: Marjolijn
authors.initials: M
authors.lastname: Ligtenberg
authors.affiliation: French Association of Quality Assurance in Pathology (AFAQAP), Hospital d'Hautepierre, Strasbourg, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Fetique
authors.affiliation: Department of Pathology, Radboud University Medical Center, Nijmegen, the Netherlands.
authors.forename: Bastiaan
authors.initials: B
authors.lastname: Tops
authors.affiliation: Molecular Biology Cancer Platform from the region Nord Pas de Calais, Lille, France.
authors.forename: Clotilde
authors.initials: C
authors.lastname: Descarpentries
authors.affiliation: Biochemistry Unit, Department of Biology, European Hospital Georges Pompidou, Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Blons
authors.affiliation: Department of Pathology, Foch Hospital, Suresnes, France.
authors.forename: Yves
authors.initials: Y
authors.lastname: Denoux
authors.affiliation: Molecular Pathology Unit, Department of Biopathology, Center Jean Perrin, Clermont-Ferrand, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Aube
authors.affiliation: Molecular Pathology Unit, Department of Biopathology, Center Jean Perrin, Clermont-Ferrand, France.
authors.forename: Frederique
authors.initials: F
authors.lastname: Penault-Llorca
authors.affiliation: Laboratories of Clinical and Experimental Pathology, Pasteur Hospital, CHU de Nice, Nice, France.
authors.forename: Paul
authors.initials: P
authors.lastname: Hofman
authors.affiliation: Department of Pathology, Hospital Henri Mondor, Creteil, France.
authors.forename: Karen
authors.initials: K
authors.lastname: Leroy
authors.affiliation: Laboratory of Anatomical Pathology, Molecular Genetics and Histocompatibility, Platform of Molecular Cancer Genetics, CHRU Brest, Brest, France.
authors.forename: Cédric
authors.initials: C
authors.lastname: Le Marechal
authors.affiliation: Laboratory of Anatomical Pathology, Molecular Genetics and Histocompatibility, Platform of Molecular Cancer Genetics, CHRU Brest, Brest, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Doucet
authors.affiliation: Solid Tumor Genetics, Pasteur Hospital, CHU de Nice, Nice, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Duranton-Tanneur
authors.affiliation: Solid Tumor Genetics, Pasteur Hospital, CHU de Nice, Nice, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Pedeutour
authors.affiliation: Molecular Pathology Unit, Institute Bergonié, Bordeaux, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Soubeyran
authors.affiliation: Laboratory of Anatomical Pathology, Hospital Tenon, Paris, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Côté
authors.affiliation: Department of Pathology, Hospital Ambroise Paré, Boulogne-Billancourts, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Emile
authors.affiliation: Laboratory of Anatomical Pathology, CHU Nancy-Central Hospital, Nancy, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Vignaud
authors.affiliation: Laboratory of Anatomical Pathology, CHU Nancy-Central Hospital, Nancy, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Monhoven
authors.affiliation: Laboratory of Molecular Biology, Department of Biopathology, Center Léon Bérard, Lyon, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Haddad
authors.affiliation: Biochemistry Unit, Department of Biology, European Hospital Georges Pompidou, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Laurent-Puig
authors.affiliation: Department of Pathology, Radboud University Medical Center, Nijmegen, the Netherlands.
authors.forename: Han
authors.initials: H
authors.lastname: van Krieken
authors.affiliation: National Cancer Institute (INCa), Boulogne-Billancourt, France.
authors.forename: Frederique
authors.initials: F
authors.lastname: Nowak
authors.affiliation: National Cancer Institute (INCa), Boulogne-Billancourt, France.
authors.forename: Etienne
authors.initials: E
authors.lastname: Lonchamp
authors.affiliation: French Association of Quality Assurance in Pathology (AFAQAP), Hospital d'Hautepierre, Strasbourg, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Bellocq
authors.affiliation: Unit of Constitutional and Somatic Genetics, Genetics Department, Institut Curie, Paris, France.
authors.forename: Etienne
authors.initials: E
authors.lastname: Rouleau
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics* / Q000473:pathology; D015179:Colorectal Neoplasms / Q000235:genetics* / Q000473:pathology; D005602:France; D005820:Genetic Testing / Q000592:standards; D060005:Genotyping Techniques / Q000592:standards; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000592:standards*; D008175:Lung Neoplasms / Q000235:genetics* / Q000473:pathology; D053842:Microsatellite Instability; D013997:Time Factors