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

机译：基于日本，美国和欧盟生物标志物的使用和批准历史的伴侣诊断的全球发展战略

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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 website, 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 into account when developing companion diagnostics globally was specified. This flowchart is expected to serve as a guide for streamlining the development of companion diagnostics.
机译：目的：本研究的目的是确定日本与西方之间在生物标志物使用和伴随诊断学发展方面的差距。我们还阐述了伴随诊断开发的潜在方案。方法：日本，美国和欧盟的药品标签信息可从每个监管机构的网站获取，以及日本和美国的体外诊断测试标签信息。结果：在全球范围内进行伴随诊断时，有必要考虑两个因素：基因突变的种族差异以及临床试验中患者选择的方法。制定了涵盖四种情况的流程图。结论：指定了在全球范围内开发伴随诊断程序时应考虑的两个因素。该流程图有望作为简化伴随诊断程序开发的指南。

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