Global development strategy for companion diagnostics based on the usage and approval history for biomarkers in Japan, the USA and the EU

Aim: The aim of this study was to identify gaps between Japan and the West in biomarker usage and the development of companion diagnostics. We also elaborated potential scenarios for companion diagnostic development. Methods: Information on drug labels in Japan, the USA and the EU was obtained from each regulatory authority's web site, as well as label information on in vitro diagnostic testing in Japan and the USA. Results: It is necessary to consider two factors when developing companion diagnostics globally: ethnic differences in gene mutations, and the approach to patient selection in clinical trials. A flowchart covering four scenarios was developed. Conclusion: Two factors that should be taken account when developing companion diagnostics globally was specified. This flowchart is expected to serve as a guide for streaming the development of companion diagnostics.