There is a new trend in anti-cancer therapeutics development: a targeted therapy and precision medicine that targets a subgroup of patients with specific biomarkers. An in vitro diagnostic (IVD) assay is required to identify a subgroup of cancer patients who would benefit from the targeted therapy or will not likely benefit or will have a high risk of side effects from the specific drug treatment. This IVD or medical device is called a companion diagnostic (CDx) assay. It is a key to have a robust CDx assay or device for the success of targeted therapy and precision medicine.
This book covers the technical, historical, clinical, and regulatory aspects of CDx in precision medicine. Clearly, more and more newly developed oncology drugs will require accompanying CDx assays, and this book, with chapters contributed by renowned oncologists, provides a comprehensive foundation for the knowledge and application of CDx for precision medicine.
- Provides comprehensive guidelines for developing targeted anti-cancer therapeutics and accompanying CDx assays for pharmaceutical and biotech companies
- Provides up-to-date status and list of US FDA approved CDx assays and detailed analysis for various assay platforms, biomarkers, cancer types for CDx
- Helps researchers and clinicians understand the importance of CDx for precision medicine