Companion diagnostics (CDx) are essential to the practice of precision medicine. Next-generation sequencing is an increasingly important tool in the development of CDx. However, for CDx to be deployed, many different biopharma industry sectors need to collaborate. This paper outlines some of the challenges and opportunities perceived by the biopharmaceutical industry, the Europe Molecular Quality Network, a regulatory agency, a notified body and a CDx service provider.

中文翻译：

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CDx，NGS和法规：Pistoia联盟的五种观点。

伴侣诊断（CDx）对于精确医学的实践至关重要。下一代测序是CDx开发中越来越重要的工具。但是，要部署CDx，许多不同的生物制药行业需要合作。本文概述了生物制药行业，欧洲分子质量网络，监管机构，指定机构和CDx服务提供商所面临的一些挑战和机遇。