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Companion Diagnostics in Personalized Medicine and Cancer Therapy
Date:8/6/2014

ng the Adoption of Pharmacogenomics (PGx)? 112
5.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 113
5.35 FDA Guidance Document on Co-development 113
5.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 113
5.37 What is the Future Role of PBMs in Laboratory Services? 114

6. Companion Diagnostics and Personalized Medicine 115
6.1 Scope of This Section 115
6.2 Introduction to Companion Diagnostics and Personalized Medicine 115
6.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine 122
6.4 Examples of Personalized Medicine and Companion Diagnostic Tests 125
6.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 130

6.6 The Personalized Medicine Coalition (PMC) 132
6.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 137
6.7.1 The Changing Regulatory Landscape for Personalized Medicine 138
6.8 Companion Diagnostics Play an Increasing Role in Cancer Care 140
6.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 140
6.9.1 Epidermal Growth Factor Receptor Assay 141
6.9.2 Individualized Warfarin Therapy 143
6.9.3 UGT1A1 Molecular Assay for Camptosar 144
6.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 144
6.9.5 LabCorp and QIAGEN and Personalized Medicine for the treatment of Colorectal Cancer 144
6.9.6 LabCorp and ARCA Discovery, Inc. Personalized Medicine for Cardiovascular Disease 145
6.9.7 Roche's Metastatic Melanoma Treatment, Zelboraf (Vemurafenib) 145
6.9.8 Abbott's Late-Stage NSCLC Treatment, Xalkori (Crizotinib) 146
6.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 146
6.11 Value Chain 147
6.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 148
6.13 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 14
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