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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.

Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; 1: Overview of Companion Diagnostics (CDx) for Precision Medicine; 1.1 Introduction; 1.1.1 FDA-Approved or Cleared CDx Devices; 1.2 CDx Assay Platforms; 1.2.1 Immunohistochemistry (IHC); 1.2.2 ISH Methods (FISH or CISH); 1.2.3 Quantitative Polymerase Chain Reaction (qPCR); 1.2.4 Sanger Sequencing; 1.2.5 Next-Generation Sequencing (NGS); 1.2.6 Imaging; 1.3 CDx Assays and Targeted Therapies for Human Cancers; 1.4 Biomarkers as a Target of CDx Assays; 1.5 Conclusion

2: Companion Diagnostic (CDx) Tests in Clinical Laboratory Improvement Amendments (CLIA)-Certified Laboratories2.1 Introduction; 2.2 In vitro Diagnostics (IVD) and Laboratory-Developed Test (LDT); 2.2.1 Definitions of IVD and LDT; 2.2.2 Different Opinions from Major Stakeholders about the Increased Authority of the FDA over LDTs; 2.2.3 Classification of IVDs; 2.2.3.1 Class I: Low-risk IVD devices; 2.2.3.2 Class II: 510(k) premarket notification; 2.2.3.3 Class III: Premarket approval (PMA); 2.3 Clinical Laboratory Improvement Amendments of 1988 (CLIA)

2.3.1 Analytical Performance Characteristics for CLIA Laboratory Tests2.3.1.1 Accuracy; 2.3.1.2 Precision (reproducibility and repeatability); 2.3.1.3 Analytical sensitivity or limit of detection (LOD); 2.3.1.4 Analytical specificity; 2.3.1.5 Reportable range; 2.3.1.6 Reference range or reference interval; 2.3.1.7 Other characteristics that may be relevant; 2.3.1.8 Important characteristics and metrics for NGS analysis; 2.3.2 NGS Genetic Test Procedures in a CLIA Laboratory; 2.4 Potential Issues and Future Directions

3: Quantitative Polymerase Chain Reaction for Companion Diagnostics and Precision Medicine Application3.1 A Brief History of qPCR; 3.2 What is qPCR?; 3.3 Current Uses of qPCR in Precision Medicine; 3.4 qPCR in Oncology; 3.4.1 Lung Cancer; 3.4.2 Leukemia; 3.4.3 Breast Cancer; 3.4.4 Colorectal Cancer; 3.4.5 Gastric Cancer; 3.5 qPCR in Infectious Disease; 3.5.1 Bacteria; 3.5.2 Viruses; 3.6 Limitations of qPCR; 3.7 Future Use of qPCR in Precision Medicine; 4: Protein Biomarker Signatures in Precision Diagnostics of Cancer; 4.1 Early Diagnosis and Biomarker Profiling within Cancer

4.2 Technology Requirements for Precision Diagnostic Medical Devices4.3 Biomarker Multiplexing Provides Higher Diagnostic Accuracies; 4.4 Regulatory Considerations; 4.4.1 The US; 4.4.2 The EU; 4.4.3 China; 4.5 Other Prerequisites to the Successful Release of Protein Biomarker Signatures for Precision Diagnostics; 4.5.1 AssayWorkflow, Turnaround Time, and Hands-On Time; 4.5.2 Assay Reimbursement and Inclusion in National Guidelines; 4.6 Future Perspectives; 5: Next-Generation Sequencing (NGS) for Companion Diagnostics (CDx) and Precision Medicine; 5.1 Introduction

OCLC-licensed vendor bibliographic record.