HHE Pathology and diagnostics supplement 2018 - Page 7

evaluation 71 36 31 20 12 12 10 5 5 89.8 % 98.1% 80.0% 70.4% 94.4% 100.0% 3.4% 0.6% N/A (24/710) (1/180) 21.1% 2.8% N/A every subscheme, at least 70% of the participants were successful according to the pre-defined criteria. For the EGFR and ROS1 FISH subschemes, the percentage of successful participants was the lowest, in concordance with the higher number of laboratories analysing at least one of the samples incorrectly. On sample and laboratory levels, more technical failures were observed for ROS1 compared with other markers. Although reporting scores were all above 80% (Table 1), only 43–52% of the participants were able to correctly include the clinical interpretation of the analysis result, depending on the marker of interest. Discussion Our results demonstrate decreased error and technical failure rates on sample level in 2016 compared with previous reported results. 7,8 Average reporting scores were on an upwards trajectory since 2012. 11 Recently, longitudinal research of EQA data has indeed confirmed that obtaining laboratory accreditation 12 and frequent EQA participation 8 has a positive influence on a rapid implementation of novel biomarkers in routine practice. Although evaluated for colon cancer, EQA data also shows that the methods, region and estimations for neoplastic cell estimation are highly variable within Europe. 13 Despite improvement being obvious, assessing the current state of NSCLC biomarker analysis in 2016 revealed the importance of additional research to improve several indispensable elements, especially in the continuously evolving field of personalised medicine, where new biomarkers and technological advances are key and where incorrect results could lead to incorrect therapy decisions. 4,10 It has been hypothesised that marker-specific challenges, such as the estimation of the neoplastic cell content for EGFR, and the recent addition of ROS1 testing to the drug label of crizotinib, 8,14 might be at the base of these findings. Therefore, we recommend a multi-level research strategy with the intention to improve and maintain the quality of biomarker analysis on the long term. 4.8% 2.8% N/A (34/710) (5/180) 29.6% 11.1% N/A 63 28 N/A 88.5% 81.3% N/A 51.9% 47.6% N/A Molecular diagnostic laboratories Even though EQA schemes reflect if a sample outcome was correctly assigned, no information is available on the exact cause in case of an error or technical failure. Some errors could be due to profound problems with laboratory methodology, while others might include sample mislabelling or typing errors. Additional research is essential to evaluate the exact time point (pre-, post-, or analytical phase) of problem occurrence. Individual monitoring of EQA participants over time could reveal such critical time points in the total testing process. Moreover, this approach allows to evaluate if problems are inherent to a specific or the swit ch between two methodologies/ sample types. Additionally, it is useful to map the laboratories’ processes to prevent incorrect results and identify an optimal quality framework to tackle phase-, method- and sample-specific problems. A first analysis of this kind in 2016 revealed that error causes are indeed biomarker- specific, with the majority of problems being situated in the pre-analytical phase for EGFR 7 HHE 2018 | hospitalhealthcare.com