Comprehensive genomic profiling in clinical research studies helps to detect clinically relevant cancer driver mutations using low amount of tumor tissues within several days. Recent studies have shown that Immune checkpoint inhibitors (ICIs) treatment is promising across cancer type and multiple gene biomarkers like MSI and TMB can be a predictor of response for ICIs. OCA Plus DNA is the most comprehensive panel with more than 500 genes which can detect TMB and MSI as well as emerging biomarkers like HRR (Homologous recombination repair) genes. To evaluate the analytical performance of OCA Plus DNA, we tested sensitivity, accuracy and specificity of SNV, Indel and CNV using reference materials. In addition, to assess the reliability of TMB and MSI results, we tested commercial reference cell lines and clinical research samples tested by commercial MSI qPCR assay, respectively. The assay showed excellent analytical and clinical performance and high reproducibility between operators.
1. To evaluate the analytical performance of OCA Plus DNA
2. To assess the reliability of TMB and MSI results of OCA Plus DNA