Higher Quality of Molecular Testing, an Unfulfilled Priority: Results from External Quality Assessment for KRAS Mutation Testing in Colorectal Cancer

摘要: Precision medicine is now a key element in clinical oncology. RAS mutational status crucial predictor of responsiveness to anti–epidermal growth factor receptor agents metastatic colorectal cancer. In an effort guarantee high-quality testing services molecular pathology, the European Society Pathology has been organizing annual KRAS external quality assessment program since 2009. 2012, 10 formalin-fixed, paraffin-embedded samples, which 8 from invasive cancer tissue and 2 artificial samples cell line material, were sent more than 100 laboratories 26 countries with request for routine testing. Both genotyping reports assessed independently. Twenty-seven percent participants genotyped at least 1 incorrectly. total, less 5% distributed specimens Genotyping errors consisted false negatives, positives, incorrectly mutations. Twenty reported technical error one or samples. A review written showed that several essential elements missing, most notably interpretation test result, method sensitivity, use reference sequence. External serves as valuable educational tool assessing improving important asset monitoring assurance upon incorporation new biomarkers diagnostic services.