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CDx, NGS and regulation: five perspectives from the Pistoia Alliance.

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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… Click to show full abstract

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.

Keywords: five perspectives; regulation five; ngs regulation; cdx ngs; perspectives pistoia; cdx

Journal Title: Drug discovery today
Year Published: 2019

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