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.
Highlights
Over the last decades, personalized health care has become routine practice in the treatment of patients with non-small cell lung cancer (NSCLC) and several clinically important companion diagnostics have been implemented [1]
In 2016, ROS proto-oncogene 1 tyrosine-protein kinase (ROS1) analysis has been added as a requirement to the label of crizotinib [5, 6], which called to re-evaluate the performance of laboratories during the four external quality assessment (EQA) scheme years
The EQA results demonstrate that individual laboratories improve their testing quality if they participate to more subsequent EQA scheme years. (Table 1)
Summary
Over the last decades, personalized health care has become routine practice in the treatment of patients with non-small cell lung cancer (NSCLC) and several clinically important companion diagnostics have been implemented [1]. While the ALK gene has been included in the drug label of crizotinib since 2011, testing of ROS1 rearrangements for treatment of patients with NSCLC has recently been added to the label of crizotinib by the FDA (March 2016) and by the EMA (September 2016) for first line therapy [4,5,6]. High quality molecular testing in NSCLC is of utmost importance to prevent false-positive or false-negative results that could diminish patient prognosis or evoke unnecessary adverse treatment effects [7]. Adequate training is necessary to avoid potential pitfalls, before a predictive molecular test is implemented in routine practice
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