Evaluation of the Oncomine™ Comprehensive Assay v3 and early experience with the Oncomine Comprehensive Assay Plus on the Genexus™ System

Clinical laboratories worldwide are implementing various targeted panels to identify cancer genomic variants and ultimately improve patient outcomes. As most of the panels and NGS platforms are research use only, their application in the clinical practice has to be regulated. Comprehensive validation process to examine the test sensitivity and specificity is required prior to their clinical use. Our lab performed validation work using Oncomine Comprehensive Assay V3 GX on Genexus system. Reference standard and clinical specimen were tested across fourteen instrument runs. Key instrument performance parameters reach satisfactory level. Sensitivity was 97% in SNVs, 100% in MNVs and 100% in indels. OCAv3 is able to detected CNV of >5 copies and all 23 fusion events were detected successfully. The overall specificity of SNVs, MNVs and indels was 100%. The specificity of CNVs was 100% while 100% specificity was detected in fusion events.