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040 _aOCoLC-P
_beng
_erda
_epn
_cOCoLC-P
020 _a9780415000383
_q(electronic bk.)
020 _a0415000386
_q(electronic bk.)
020 _a9780429275906
_q(electronic bk.)
020 _a0429275900
_q(electronic bk.)
020 _a9781000000382
_q(electronic bk. : PDF)
020 _a1000000389
_q(electronic bk. : PDF)
020 _a9781000013740
_q(electronic bk. : Mobipocket)
020 _a100001374X
_q(electronic bk. : Mobipocket)
020 _a9781000007213
_q(electronic bk. : EPUB)
020 _a1000007219
_q(electronic bk. : EPUB)
020 _z9789814800235
020 _z9814800236
035 _a(OCoLC)1089445740
_z(OCoLC)1089777660
_z(OCoLC)1089998408
035 _a(OCoLC-P)1089445740
050 4 _aRC263
072 7 _aHEA
_x039000
_2bisacsh
072 7 _aMED
_x014000
_2bisacsh
072 7 _aMED
_x022000
_2bisacsh
072 7 _aMED
_x112000
_2bisacsh
072 7 _aMED
_x045000
_2bisacsh
072 7 _aCOM
_x082000
_2bisacsh
072 7 _aMED
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072 7 _aMED
_x107000
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072 7 _aPSAK
_2bicssc
082 0 4 _a616.99/4
_223
245 0 0 _aCompanion diagnostics (CDx) in precision medicine /
_cedited by Il-Jin Kim.
264 1 _aSingapore :
_bPan Stanford Publishing,
_c2019.
300 _a1 online resource
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
520 _aThere 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 _aCover; 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 _a2: 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 _a2.3.1 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 _a3: 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 _a4.2 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 _aOCLC-licensed vendor bibliographic record.
650 0 _aCancer
_xTreatment.
650 0 _aPersonalized medicine.
650 7 _aHEALTH & FITNESS / Diseases / General.
_2bisacsh
650 7 _aMEDICAL / Clinical Medicine.
_2bisacsh
650 7 _aMEDICAL / Diseases.
_2bisacsh
650 7 _aMEDICAL / Evidence-Based Medicine.
_2bisacsh
650 7 _aMEDICAL / Internal Medicine.
_2bisacsh
650 7 _aCOMPUTERS / Bioinformatics
_2bisacsh
650 7 _aMEDICAL / Biotechnology
_2bisacsh
650 7 _aMEDICAL / Genetics
_2bisacsh
700 1 _aKim, Il-Jin,
_eeditor.
856 4 0 _3Taylor & Francis
_uhttps://www.taylorfrancis.com/books/9780429275906
856 4 2 _3OCLC metadata license agreement
_uhttp://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf
999 _c128344
_d128344