HHE Pathology and diagnostics supplement 2018 - Page 5

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 non- small 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 Laboratories are challenged to implement biomarkers in their routine practice in a correct and time-efficient manner 5 HHE 2018 | hospitalhealthcare.com 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