White Paper: development, commercialization and utilization of companion diagnostics


Companion diagnostics (CDx) are the cornerstone of precision medicine, and since the first commercial use of a CDx in oncology more than 20 years ago, new FDA approvals are increasingly associated with specific therapies. In a ddition to the increased use of CDx, other factors driving the increased focus on precision medicine include a focus on a biomarker approach to drug development and the transition to personalized approaches to therapy such as cell and gene therapies. These factors have led to the increase in the number of newly approved therapies involving a precision/personalized approach, with now over 40% of newly approved therapies fitting into that category. Over the last five years, development strategies, regulatory frameworks and reimbursement models for CDx have continued to evolve as sophisticated molecular approaches and related technologies are increasing both the complexity and throughput of these assays.

This White Paper provides an overview of CDx, compares development and regulatory paths and discusses the ongoing challenges faced in the commercialization, utilization and uptake of these tests.

To download the full paper, click here.

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