Companion diagnostic: An overview of regulatory framework, challenges, and future directions.

In era of precision medicine, companion diagnostic (CDx) is prominent tool that links the gaps between diagnostics and therapeutics based on biomarker identification which helps to ensure which patient is more likely to benefit for specific treatment. Initially, the focus is on oncology treatment but in recent years the scope of CDx is gradually strengthening towards cardiology, neurology, infectious diseases and rare disorders. This review highlights the co-development of CDx with analyzation of regulatory framework in Unites State (US), Europe (EU) and in Japan. Despite of regulatory standards, there are still bottlenecks exist due to variations in approval pathways, CDx classification, technology transfer and economic issues remains major hurdle for clinical implementation. Integration of advanced technologies like Next Generation Sequencing (NGS), liquid biopsy reshaping the existing frameworks of CDx and helps to tackle existing issues. AI (Artificial Intelligence) in CDx further holds the potential to expedite the biomarker discovery which helps in designing clinical trials studies, improves patient access and provide real time monitoring of treatment response. In addition to this AI driven technologies can able to expedite regulatory decision-making process by evaluating vast, complex data sets in short period of time that ultimately enhance adaptability of CDx development. Overall, these combination of technologies focus on evolution of CDx across the regions to expand the precision medicine approach.