The evolution of clinical trial design in oncology reflects the current clinical paradigm of personalized medicine, weighing both histology and molecularly-defined biomarkers as the pillars for therapy selection. The number of predictive biomarkers in oncology is rapidly increasing, creating new treatment opportunities for cancer patients but also requiring additional costs and multiple tests. Complex profiling demanding extensive genomic analysis can be optimized by implementing comprehensive Next-Generation Sequencing (NGS) assays. In particular, broad but targeted NGS panels represent a viable option for diagnostics. Combining a large number of biomarkers in only one assay allows a reduction of turn-around-time at reasonable costs. Nevertheless, broad molecular profiling comes at the price of additional analysis time and the need for allocating supplementary resources. Benefits and drawbacks need to be carefully evaluated based on the clinical history of the patient. We address the benefits of comprehensive genomic profiling, particularly in the context of immuno-oncology, and assess the performance of the Oncomine™ Comprehensive Assay Plus for clinical sample profiling.
1. Identify the opportunities of comprehensive genomic profiling
2. Define biomarkers in immunooncology in the context of broad molecular profiling