Pathology and Diagnostics
Predictive biomarker analysis in NSCLC
This manuscript highlights the results of the 2016 External Quality Assurance scheme for EGFR , ALK and ROS1 biomarker analysis in non-small cell lung cancer
Cleo Keppens MSc
Kelly Dufraing MSc
Prof Dr Elisabeth Dequeker University of Leuven , Department of Public Health and Primary Care , Biomedical Quality Assurance Research Unit , Leuven , Belgium
The reliability and accuracy of biomarker testing in molecular diagnostic laboratories is important for optimal patient care , because its results are used by clinicians to predict the most appropriate treatment option . To date , several biomarkers have been added to the drug labels of targeted therapies by the US Food and Drug Administration and the European Medicines Agency as a requirement prior to the administration of drugs to patients with nonsmall cell lung cancer ( NSCLC ). Technological advances led to the discovery of novel biomarkers , and to a shifting landscape from testing one gene towards testing multiple genes in parallel . 1 Hence , laboratories are challenged to implement biomarkers in their routine practice in a correct and time-efficient manner . 2 , 3
External quality assessment ( EQA ) schemes provide laboratories with the opportunity to verify and validate their test methods , to monitor their performance and to compare it to other laboratories worldwide . 4 In addition , EQA participation is an integral part of the quality framework of diagnostic laboratories , required by the International Organization for Standardization ( ISO 15189 ) 5 and the Clinical Laboratory Improvement Amendments . 6
Since 2012 , the European Society of Pathology ( ESP ) has organised a yearly EQA scheme for biomarker analysis in NSCLC . 7 , 8 The schemes included testing of three biomarkers , namely 1 epidermal growth factor receptor ( EGFR ) gene variants in exons 18 to 21 , 2 rearrangements of the anaplastic lymphoma kinase ( ALK ) gene , and rearrangements in the ROS proto-oncogene 1 tyrosine-protein kinase ( ROS1 ) gene . 3
Laboratories are challenged to implement biomarkers in their routine practice in a correct and time-efficient manner
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