Companion diagnostics (CDx) in precision medicine / (Record no. 128344)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 06229cam a2200721Ii 4500 |
| 001 - CONTROL NUMBER | |
| control field | 9780429275906 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | FlBoTFG |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220509193023.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION | |
| fixed length control field | m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu---unuuu |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 190308s2019 si ob 001 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | OCoLC-P |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | OCoLC-P |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780415000383 |
| -- | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 0415000386 |
| -- | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780429275906 |
| -- | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 0429275900 |
| -- | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000000382 |
| -- | (electronic bk. : PDF) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000000389 |
| -- | (electronic bk. : PDF) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000013740 |
| -- | (electronic bk. : Mobipocket) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 100001374X |
| -- | (electronic bk. : Mobipocket) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000007213 |
| -- | (electronic bk. : EPUB) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000007219 |
| -- | (electronic bk. : EPUB) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 9789814800235 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 9814800236 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1089445740 |
| Canceled/invalid control number | (OCoLC)1089777660 |
| -- | (OCoLC)1089998408 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC-P)1089445740 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RC263 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | HEA |
| Subject category code subdivision | 039000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 014000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 022000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 112000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 045000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | COM |
| Subject category code subdivision | 082000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 009000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 107000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | PSAK |
| Source | bicssc |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 616.99/4 |
| Edition number | 23 |
| 245 00 - TITLE STATEMENT | |
| Title | Companion diagnostics (CDx) in precision medicine / |
| Statement of responsibility, etc | edited by Il-Jin Kim. |
| 264 #1 - | |
| -- | Singapore : |
| -- | Pan Stanford Publishing, |
| -- | 2019. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource |
| 336 ## - | |
| -- | text |
| -- | txt |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | c |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | cr |
| -- | rdacarrier |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | 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. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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) |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 588 ## - | |
| -- | OCLC-licensed vendor bibliographic record. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Cancer |
| General subdivision | Treatment. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Personalized medicine. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | HEALTH & FITNESS / Diseases / General. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Clinical Medicine. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Diseases. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Evidence-Based Medicine. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Internal Medicine. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | COMPUTERS / Bioinformatics |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Biotechnology |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Genetics |
| Source of heading or term | bisacsh |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Kim, Il-Jin, |
| Relator term | editor. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | Taylor & Francis |
| Uniform Resource Identifier | https://www.taylorfrancis.com/books/9780429275906 |
| 856 42 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | OCLC metadata license agreement |
| Uniform Resource Identifier | http://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf |
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