Companion and Complementary Diagnostics

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