Rapid turnaround Oncomine Precision Assay enables global harmonization for clinical trial testing

Genetic variation in neoplasia can take the form of single or multiple nucleotide variants, gene fusions, amplifications, and/or splice variations. This heterogeneity can pose a challenge in comprehensive profiling to guide therapeutic decision making. The Oncomine™ Precision Assay on the Genexus™ Integrated Sequencer (OPAGX) is an amplicon-based automated NGS assay that enables detection of all these genomic variant classes, spanning 50 genes, focused on those with greatest clinical relevance and targets of many ongoing trials. The complete workflow, from library prep to final report generation, can be accomplished in less than 30 hours for up to 32 formalin-fixed, paraffin embedded (FFPE) samples. OPAGX uses AmpliSeq™ HD technology, utilizing unique molecular tags for sequencing error correction and increased sensitivity of variant detection. The assay, previously characterized at a Durham, NC, US-based site, was transferred to and validated by a genomics laboratory in Beijing, China to enable global harmonization of clinical trial testing.


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