Summary of DIA Workshop on Co-Development of Personalized Medicine and In Vitro Diagnostic Companion Devices

Abstract

The pairing of personalized medicine, including targeted drug therapy, and in vitro diagnostic (IVD) companion devices (ie, “companion diagnostics”) allows treatment decisions to be tailored for each patient. However, development of companion diagnostics and personalized medicine still faces challenges in clinical development as regulatory policy tries to keep up with and accommodate this growing field. To assist industry and regulators, the DIA provided a forum for the discussion of current challenges and opportunities for progressive alignment approaches to regulating personalized medicine and IVD devices.

Keywords

DIA personalized medicine in vitro diagnostic (IVD) companion devices companion diagnostics co-development alignment between development and regulatory requirements

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