A stitch in time saves nine: external quality assessment rounds demonstrate improved quality of biomarker analysis in lung cancer
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Cleo Keppens1, Véronique Tack1, Nils ‘t Hart2, Lien Tembuyser1, Ales Ryska3, Patrick Pauwels4, Karen Zwaenepoel5, Ed Schuuring2, Florian Cabillic6,7, Luigi Tornillo8,9, Arne Warth10, Wilko Weichert11 and Elisabeth Dequeker1 for the EQA assessors expert group12
1University of Leuven, Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, Leuven, Belgium
2University Medical Center Groningen, Department of Pathology, Groningen, The Netherlands
3Charles University Medical Faculty and University Hospital, Department of Pathology, Hradec Kralove, Czech Republic
4Center for Oncologic Research (CORE), University of Antwerp, Antwerp, Belgium
5University Hospital Antwerp, Department of Pathology, Edegem, Belgium
6Cytogenetics and Cellular Biology Department, CHU de Rennes, Rennes, France
7INSERM, INRA, Université Rennes 1, Université Bretagne Loire, Nutrition Metabolisms and Cancer, Rennes, France
8University of Basel, Basel, Switzerland
9GILAB AG, Allschwil, Switzerland
10University Hospital Heidelberg, Heidelberg, Germany
11Technical University Munich (TUM), Munich, Germany
12The EQA assessors expert group
Elisabeth Dequeker, email: firstname.lastname@example.org
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
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.
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