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    Development of companion diagnostics (CDx) as powerful tools in precision medicine typically follows one of three pathways: co-development, bridging, and follow-on Co-development is the most ideal and cost-effective CDx pathway: It is conducive to screening target patients specifically and identifying drug targets accurately, reducing development cost and cycle times for pharmaceutical
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    As these national guidelines and regulations continue to create favorable conditions for development of drug-CDx reagents in China, industry has responded with calls for China’s companion diagnostic products regulation to keep pace with drug regulation reform, to learn from advanced regulatory systems like those in Europe and the US, and for
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    Integral to PM are companion diagnostics (CDx), devices designed and developed to select the right patient candidates for the precision drug Inevitably, this codependent relationship between drug and device flags the need for tight coordination of the development and regulatory review of both products to ensure timely access to PM CDx





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