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EU IVD Regulation - What does it mean for companion diagnostics and LDTs?

EU IVD Regulation - What does it mean for companion diagnostics and LDTs?

19 January, 2018

Authors

Dave Smart

Director

Dave Smart, PhD, Director at Diaceutics, discusses the introduction of the EU IVD Regulation. While it is considered a necessary step, the Regulation raises issues not only for labs and those manufacturing companion diagnostic and laboratory developed tests, but also for pharma, all of whom need to be aware of potential grey areas where more clarity is needed.

Tags

Laboratories IVDR Regulatory Lab Developed Tests (LDT)

About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. 

Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

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