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Updated: Jan 22, 2026

Perspectives on Neuroscience
Published on: July 31, 2007
CDx, NGS and regulation: five perspectives from the Pistoia Alliance
John Wise1, Mike Furness1, Stewart McWilliams2
1Pistoia Alliance, Wakefield, MA, USA.
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.
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