A stitch in time saves nine: external quality assessment rounds demonstrate improved quality of biomarker analysis in lung cancer

// Cleo Keppens 1 , Véronique Tack 1 , Nils ‘t Hart 2 , Lien Tembuyser 1 , Ales Ryska 3 , Patrick Pauwels 4 , Karen Zwaenepoel 5 , Ed Schuuring 2 , Florian Cabillic 6, 7 , Luigi Tornillo 8, 9 , Arne Warth 10 , Wilko Weichert 11 and Elisabeth Dequeker 1 for the EQA assessors expert group 12 1 University of Leuven, Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, Leuven, Belgium 2 University Medical Center Groningen, Department of Pathology, Groningen, The Netherlands 3 Charles University Medical Faculty and University Hospital, Department of Pathology, Hradec Kralove, Czech Republic 4 Center for Oncologic Research (CORE), University of Antwerp, Antwerp, Belgium 5 University Hospital Antwerp, Department of Pathology, Edegem, Belgium 6 Cytogenetics and Cellular Biology Department, CHU de Rennes, Rennes, France 7 INSERM, INRA, Université Rennes 1, Université Bretagne Loire, Nutrition Metabolisms and Cancer, Rennes, France 8 University of Basel, Basel, Switzerland 9 GILAB AG, Allschwil, Switzerland 10 University Hospital Heidelberg, Heidelberg, Germany 11 Technical University Munich (TUM), Munich, Germany 12 The EQA assessors expert group Correspondence to: Elisabeth Dequeker, email: els.dequeker@kuleuven.be Keywords: non-small cell lung cancer; external quality assessment; molecular pathology; biomarker analysis; targeted therapy Received: November 07, 2017      Accepted: February 26, 2018      Published: April 17, 2018 ABSTRACT Biomarker analysis has become routine practice in the treatment of non-small cell lung cancer (NSCLC). To ensure high quality testing, participation to external quality assessment (EQA) schemes is essential. This article provides a longitudinal overview of the EQA performance for EGFR , ALK , and ROS1 analyses in NSCLC between 2012 and 2015. The four scheme years were organized by the European Society of Pathology according to the ISO 17043 standard. Participants were asked to analyze the provided tissue using their routine procedures. Analysis scores improved for individual laboratories upon participation to more EQA schemes, except for ROS1 immunohistochemistry (IHC). For EGFR analysis, scheme error rates were 18.8%, 14.1% and 7.5% in 2013, 2014 and 2015 respectively. For ALK testing, error rates decreased between 2012 and 2015 by 5.2%, 3.2% and 11.8% for the fluorescence in situ hybridization (FISH), FISH digital, and IHC subschemes, respectively. In contrast, for ROS1 error rates increased between 2014 and 2015 for FISH and IHC by 3.2% and 9.3%. Technical failures decreased over the years for all three markers. Results show that EQA contributes to an ameliorated performance for most predictive biomarkers in NSCLC. Room for improvement is still present, especially for ROS1 analysis.