MDIC and its partners are collaborating to establish a foundation for the use of surrogate samples to support IVD product development and the regulatory process. This project aims to provide solutions to the difficulty found with obtaining clinical specimens which delays the development of innovative and improved diagnostics impacting patient access.

With industry stakeholders, MDIC has created the Surrogate Sample Framework which proposes uniform terminology and recommendations where surrogate samples might be justifiably used in IVD validation studies.

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