Rapid implementation of a personalized medicine research program (PMRP), using a targeted next-generation sequencing (NGS) assay, in the community setting.

Abstract

e22055 Background: Cancer care is evolving to a model of precision medicine where somatic genomic changes in a patient’s (pt’s) tumor are increasingly used to inform individualized management. We report rapid implementation of a PMRP in the hybrid setting of a non-university, community based research practice. Methods: A custom designed gene alteration (GA) panel covering all relevant regions of 68 genes was developed using sequencing by synthesis on an NGS platform. The NGS results were used to: 1-prioritize standard therapies; 2-match pts with clinical trials (CTs); and 3-serve as a data mining resource. An Institutional Review Board (IRB) approved prospective registration protocol was activated in September, 2014 with the objective of establishing a centralized longitudinal clinical, molecular phenotypic, and research data repository for newly diagnosed pts. Analysis endpoints include proportion of pts where NGS influenced management or enrollment in CTs. NGS results were categorized as actionable (app...