Title: External Quality Assessment for KRAS Testing Is Needed: Setup of a European Program and Report of the First Joined Regional Quality Assessment Rounds
Authors: Bellon, Ellen
Ligtenberg, Marjolijn J L
Tejpar, Sabine
Cox, Karen
De Hertogh, Gert
de Stricker, Karin
Edsjö, Anders
Gorgoulis, Vassilis
Höfler, Gerald
Jung, Andreas
Kotsinas, Athanassios
Laurent-Puig, Pierre
López-Ríos, Fernando
Hansen, Tine Plato
Rouleau, Etienne
Vandenberghe, Peter
van Krieken, Johan J M
Dequeker, Els # ×
Issue Date: Mar-2011
Publisher: AlphaMed Press
Series Title: The Oncologist vol:16 issue:4 pages:467-478
Abstract: Abstract The use of epidermal growth factor receptor-targeting antibodies in metastatic colorectal cancer has been restricted to patients with wild-type KRAS tumors by the European Medicines Agency since 2008, based on data showing a lack of efficacy and potential harm in patients with mutant KRAS tumors. In an effort to ensure optimal, uniform, and reliable community-based KRAS testing throughout Europe, a KRAS external quality assessment (EQA) scheme was set up. The first large assessment round included 59 laboratories from eight different European countries. For each country, one regional scheme organizer prepared and distributed the samples for the participants of their own country. The samples included unstained sections of 10 invasive colorectal carcinomas with known KRAS mutation status. The samples were centrally validated by one of two reference laboratories. The laboratories were allowed to use their own preferred method for histological evaluation, DNA isolation, and mutation analysis. In this study, we analyze the setup of the KRAS scheme. We analyzed the advantages and disadvantages of the regional scheme organization by analyzing the outcome of genotyping results, analysis of tumor percentage, and written reports. We conclude that only 70% of laboratories correctly identified the KRAS mutational status in all samples. Both the false-positive and false-negative results observed negatively affect patient care. Reports of the KRAS test results often lacked essential information. We aim to further expand this program to more laboratories to provide a robust estimate of the quality of KRAS testing in Europe, and provide the basis for remedial measures and harmonization.
ISSN: 1083-7159
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Department of Human Genetics - miscellaneous
Biomedical Quality Assurance Research Unit
Translational Research in GastroIntestinal Disorders
Translational Cell & Tissue Research
Molecular Digestive Oncology (+)
× corresponding author
# (joint) last author

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