All Times EDT
Keywords: ctDNA, early endpoint, in-vitro diagnostic device, analytical validation, clinical validation
Recent development of ctDNA as a biomarker has been advanced to molecular profiling at diagnosis, patient selection for target therapy, minimal residual disease (MRD) detection, treatment response monitoring and etc. To potentially use ctDNA as an early endpoint, there are still lots of challenges for assay development. In this talk, we will discuss the statistical challenges and considerations from a regulatory perspective, especially the analytical and clinical validation for in-vitro diagnostic devices when using ctDNA as a potentially early endpoint.