Companion diagnostics (CDx) in precision medicine. (2019)

• Record Type: Book
• Further Information: Note: Edited by Il-Jin Kim.
• Editors: Kim, Il-Jin
• Contents: 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
• Publisher Details: Singapore : Pan Stanford Publishing
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 616.99/4; Cancer -- Treatment; Personalized medicine; HEALTH & FITNESS / Diseases / General; MEDICAL / Clinical Medicine; MEDICAL / Diseases; MEDICAL / Evidence-Based Medicine; MEDICAL / Internal Medicine; COMPUTERS / Bioinformatics; MEDICAL / Biotechnology; MEDICAL / Genetics; Electronic books; Electronic books
• Languages: English
• ISBNs: 9780415000383; 0415000386; 9780429275906; 0429275900; 9781000000382; 1000000389; 9781000013740; 9781000007213; 1000007219
• Related ISBNs: 100001374X; 9789814800235; 9814800236
• Notes: Note: Includes bibliographical references and index.; Note: Online resource; title from PDF title page (EBSCO, viewed March 11, 2019)
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.