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 not likely benefit, or 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 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.
Table of Contents
Overview of Companion Diagnostics (CDx) for Precision Medicine. Companion Diagnostic (CDx) Tests in Clinical Laboratory Improvement Amendments (CLIA)-Certified Laboratories. Quantitative Polymerase Chain Reaction for Companion Diagnostics and Precision Medicine Application. Protein Biomarker Signatures in Precision Diagnostics of Cancer. Next-Generation Sequencing (NGS) for Companion Diagnostics (CDx) and Precision Medicine. Molecular Pathologic Diagnostics for Personalized Medicine. Establishment and Characterization of Cancer Cell Lines for Companion Diagnostics. Companion Diagnostics for Oncogenic Fusion Proteins. Clinical Trial Designs for Testing Companion Diagnostics (CDx). Companion Diagnostics and Precision Medicine for Colorectal Cancer. Molecular Diagnostics of Chronic Myeloid Leukemia: Precision Medicine via Gold Nanoparticles. Adaptive Resistance Mechanisms in EGFR Mutant NSCLC.
Il-Jin Kim (DVM, PhD, PMP, BCMAS, CCRP) was director of Applied Genomics in the UCSF Thoracic Oncology Program and is now medical director at Guardant Health, USA.