Towards the Implementation of High-Throughput Next-Generation Sequencing Technology in Clinical Oncology. Where Are We Now?

High-throughput next-generation sequencing (NGS) has changed clinical oncology practice. Over the past two decades, this technology has evolved from the first oncogenomic projects and clinical trials to the introduction of comprehensive genomic profiling (CGP) into practical oncology guidelines. However, despite this fact NGS studies, with rare exceptions, are represented worldwide by commercial products that are not approved for clinical use. The legislative regulation of molecular genetic studies based on the NGS technology intended for clinical use is significantly inferior to the emergence rate of new technologies. For example, 11 years passed between the start of the first oncogenomic project and the approval of the world’s first targeted cancer NGS panel for comprehensive genomic profiling. This review analyzes the implementation of the NGS technology in oncology and the emergence of regulation of such molecular tests with the formation of recommendations for Russian regulatory practice.