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© 2019 Elsevier Inc. All rights reserved. This chapter will introduce companion diagnostics (CDxes), its current status, economic and regulatory aspects of CDx, and its future potential while discussing specific disease areas as well as the analytical technologies that are likely to dominate. It will first start by providing an overview of CDx, its definition, and some of the mechanisms that underlie its development. The chapter will then discuss the current status of CDx, its uses in medicine, and critical aspects of its development demonstrated in the discussion about codevelopment, with factors contributing to a market size exceeding 2 billion US dollars. An overview of the present economic and regulatory issues will also be discussed. Specific disease areas such as oncology, aging-related diseases, and other diseases will be considered concerning their future aspects in the use of CDx and the analytical technologies that will underlie their development.

Original publication





Book title

Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation

Publication Date



455 - 472