Milestone to Ensure Safety and Efficacy of Companion Diagnostic (CDx) That Support Treatment Decisions in Cancer Patients.

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 ana