RAS testing in metastatic colorectal cancer : Excellent reproducibility amongst 17 Dutch pathology centers

摘要: // Annemarie Boleij 1 , Bastiaan B.J. Tops 2 Paul D.M. Rombout Elizabeth M. Dequeker 3 Marjolijn J.L. Ligtenberg 1,2 J. Han van Krieken and Dutch RAS EQA Initiative 4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20 Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands Human Genetics, Public Health Primary Care, Biomedical Quality Assurance Research Unit, KU Leuven - Leuven, Belgium 4 C.J.M. Noesel, Academic Center (AMC), Amsterdam 5 C.C. Scheidel-Jacobse (Technical specialist), J.A. Kummer (Pathologist/KMBP), P. Roepman (KMBP in training), St. Antonius Ziekenhuis, Nieuwegein 6 C.F.M. Prinsen (KMBP), S.H.M. den Berg-van Erp (Pathologist), Canisius Wilhelmina Ziekenhuis (CWZ), Nijmegen 7 J.M.H.H. Gorp, Diakonessenhuis, Laboratory for Utrecht 8 P.M. Nederlof, Cancer Institute (NKI), Amsterdam. 9 E. Caspers, Elisabeth Molecular Tilburg 10 W.N.M. Dinjens, E.C.W. Beerens, Erasmus MC, Diagnostics, Rotterdam 11 N.A. ‘t Hart, Isala, Zwolle 12 A.J.C. Brule, Jeroen Bosch ‘s-Hertogenbosch 13 R. der Geize S.A. Riemersma Pathology Oost-Nederland (LABPON), Hengelo 14 T. Wezel H. Morreau Eijk Leiden (LUMC), 15 J.W.M. Jeuken, Microbiology (PAMM), Eindhoven 16 A. Dirkx, Pathan B.V., 17 Klomp, Rijnstate Arnhem 18 W.T.M Blokland, (UMC) Utrecht, 19 ter Elst specialist/KMBP Schuuring Diepstra Groningen (UMCG), 20 D.A.M. Heideman N.C.T. Grieken D. Sie VU-University (VUMC), Correspondence to: J.Han Krieken, email: Keywords : RAS, colorectal cancer, metastasis, quality control, next generation sequencing Received February 09, 2015 Accepted March 18, Published April 12, Abstract In 2013 the European Medicine Agency (EMA) restricted indication anti-EGFR targeted therapy to metastatic cancer (mCRC) with a wild-type gene, increasing need reliable mutation testing. We evaluated completeness reproducibility -testing Netherlands. From laboratories, tumor DNA first CRC cases tested 2014 routine clinical practice was re-tested by reference laboratory using custom panel. total, 171 were re-evaluated hotspot mutations KRAS NRAS BRAF . Most laboratories had introduced complete (65%) (71%) January 2014. most employed method all regions Sanger (range 35.7 – 49.2%). detected that been found participating ( n = 92), plus additional mutations. This concerned three seven missed due incomplete testing laboratory. Overall, concordance tests performed both 100% (163/163; κ-static 1.0) (144/144; Our study shows can be reproducibly assessed variety methods.