Abstract
As demand for biomarker-based companion diagnostics (CDx) tests in clinical oncology of precision medicine increases, a clear understanding of the regulatory framework (especially analytical and clinical performance) is imperative to ensure the safety and efficacy of CDx in enhancing patient quality of life and aiding in treatment decisions. This study analyzes the regulatory policies and approval reports in major countries and identifies regulatory checklists for the pre- and post-marketing analytical and clinical performance to ensure safety and efficacy of CDx. It categorizes the pre-marketing analysis into four commonly used techniques, IHC, FISH, PCR, and NGS, reflecting the diversity of CDx types. All analyses are grounded in the latest regulations and guidelines. The developed checklists were subjected to feasibility assessment by industry experts. Our analysis revealed that there are differences in the pre- and post-marketing regulatory frameworks for CDx, reflecting unique characteristics of each country. In particular, differences were observed in the safety and efficacy assessment methods applied to the platform based on technological principle. Evidence-based checklists are established, which support manufacturers in implementing efficient practices and creating systematic regulatory strategies. Furthermore, these checklists facilitate global market access, activate R&D, enhance clinical implementation, and improve licensing practices.