| Popis: |
Precision medicine (PM) is an innovative approach to tailor disease prevention and treatment that takes into account differences in people’s genes, environments, and lifestyles with the goal to target the right treatments to the right patients at the right time. While the personalization of medicine has been recognized for as long as people have been practicing medicine about 400–500 years BC, the initiative has been a hot topic from drug and diagnostic developers, clinicians, and regulators over the past two decades. To enable PM a diagnostic test, commonly known as companion diagnostic (CDx), has to be approved and comarketed with the targeted therapy in order to select patients who can be eligible for the treatment. The approval of HercepTest in 1998 for Herceptin in breast cancer stimulated the appetites of stakeholders, and now the FDA-approved CDx exceeds 40 devices. This chapter discusses the value of PM and CDx in drug development and highlight the different models of CDx development and regulatory approval. |
