Abstract Next-generation sequencing (NGS) refers to the class of technologies that perform DNA and ribonucleic acid (cDNA), sequencing in a massively multiplexed and parallel manner allowing genetic and genomic molecular typing of individuals with high accuracy. NGS is a disruptive technology in both research and drug discovery as well as for clinical testing and diagnostics. Within the past few years, there has been a parallel effort on the development of regulatory guidance and oversight for NGS-based tests for genomics-based precision medicine initiatives. The culmination of the parallel technology development and regulatory and policy changes have led to a rapid adoption of NGS into the clinic with several NGS-based diagnostics achieving regulatory approval, including as companion and complementary diagnostics. The NGS companion diagnostic space is extremely dynamic and evolving, and it seems evident that we are entering a time of even further growth and impact.