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Companion Diagnostics in Personalized Medicine and Cancer Therapy

Therapeutics by Third-Party Payers 86
5.7 Biotechnology Industry Trends 87
5.8 Pharmaceutical Industry Trends 87
5.9 Acquisition, License Agreement, Partnerships 88
5.10 Legal Developments 94
5.11 Sales and Marketing Strategies for Tumor Marker Tests 95
5.11.1 International Markets 97
5.11.2 Europe 97
5.11.3 Central and South America 98
5.11.4 Asia-Pacific 98
5.12 Product Commercialization 99
5.13 Reimbursement 100
5.14 Self-Referral Rules 101
5.15 Health Insurance Portability and Accountability Act 102

5.16 Clinical Laboratory Improvement Amendments (CLIA) 102
5.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 103
5.18 FDA's Quality System Regulation (QSR) 104
5.19 The FDA's OIVD on IVDMIAs 104
5.20 FDA's Qualification of Cancer Biomarkers 105
5.20.1 Regulatory Perspectives of Biomarker Validation 105
5.21 Genetic Tests and Medical Records 106
5.21.1 Laws Against Genetic Discrimination 107
5.22 Global Drivers of Clinical Laboratory Testing 107
5.23 Global Outlook 108
5.24 Oncology Biomarker Qualification Initiative 109
5.25 FDA Critical Path 109
5.26 Biomarkers and FDA's Voluntary Genomic Data Submission 110
5.27 From Personalized to Predictive Medicine 110
5.28 Analysis of Cost-Effectiveness at the Individual Level 110
5.29 The Patient and Advocate Perspective: An Evolution of Influence 110
5.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 110
5.30.1 Evolving Business Models in Companion Diagnostics and Personalized Medicine 111
5.30.2 Current Pharma/Diagnostics Business Model Examples 112
5.31 Reimbursement and Value Creation 112
5.32 What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics? 112
5.33 What is the Role of the Insurance Industry in Drivi

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