Companion and Complementary Diagnostics

Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies.

• Covers all aspects, from biomarker discovery, to development and regulatory approval
• Explains the "how to" aspects of companion diagnostics
• Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

Scientists and health care professionals working in academic research institutions, hospitals as well as pharma, biotech and diagnostic companies. Academics such as molecular biologists, human biologists, clinical chemists, bio-engineers, biostatisticians/bioinformatics, pharmacists, pathologists, and clinicians

1. Foreword
2. An Introduction to Companion and Complementary Diagnostics
3. The Drug-Diagnostic Co-Development Model
4. Systems Biology and Biomarker Development in Cancer Signaling Therapy
5. Immunohistochemistry
6. In Situ Hybridization
7. Polymerase Chain Reaction
8. Next Gen Sequencing Based Companion Diagnostics: From Biomarker Discovery to Clinical Implementation
9. Current Next Generation Sequencing Based Companion Diagnostics and their Analytical Validation
10. Companion and Complementary Diagnostics by Mass Spectrometry
11. Molecular Imaging Companion Diagnostics
12. Circulating Tumor DNA Analysis and Opportunities for Personalized Cancer Medicine
13. Companion Diagnostics Assay Development – Prototype, Verification and Analytical Validation
14. Tissue is the Issue: Challenges in Oncology Clinical Trial Tissue Sample Collection for Biomarker Analyses and Companion Diagnostics
15. Adaptive Trial Designs for Biomarker Driven Clinical Trials with Quantitative and Multiple Candidate Biomarkers
16. Companion Diagnostics Based on Time to Event Data
17. Regulatory Requirements for Companion Diagnostics and Drug-Diagnostic Co-Development in the United States of America
18. Companion Diagnostics and Biomarker Tests in the European Medicines Agency’s Assessment of Medicinal Products
19. Understanding the Current Regulatory Landscape for Companion Diagnostic Products in China
20. Regulatory requirements for companion diagnostics – Japan
21. Economic Evaluation of Companion and Complementary Diagnostics
22. A Risk Based Paradigm of Biomarkers in Clinical Trials
23. Implementing Companion Diagnostic Testing in the Clinic
24. Osimertinib (TAGRISSO) and the cobas EGFR Mutation Test v2
25. QMS Omecamtiv Mecarbil Immunoassay and Omecamtiv Mecarbil Co-Development
26. Current Status and Future Direction of Companion Diagnostics