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

Impact in Areas of Personalized Medicine 33
Table 2.5: Impact of Personalized Medicine on Various Therapeutic Areas 34
Table 3.1: Diagnostic Facts 39
Table 3.2: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 44
Table 3.3: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 44
Table 3.4: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 45
Table 3.5: FDA Classification of Diagnostics by Risk 47
Table 4.1: Potential Benefits of Biomarkers as Companion Diagnostics 50
Table 4.2: Utility of Biomarker as Companion Diagnostics to Drug Development 51
Table 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 56
Table 4.4: Drivers of Companion Diagnostics Discovery 65
Table 4.5: Barriers to Companion Diagnostics Discovery 66
Table 4.6: Device Submission Elements for the FDA 66
Table 5.1: List and Discounted Prices for Abbott Tumor Marker Tests 78
Table 5.2: Recent Major Companion Diagnostics Deals 89

Table 5.3: Summary of Biomarker Use in the Commercialization of Novel Oncology
Pharmacotherapeutics 111
Table 5.4: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion
Diagnostic Tests 111
Table 6.1: Timeline for Development of Companion Diagnostics 118
Table 6.2: Personalized Medicine at the Nexus Point 120
Table 6.3: Percentage of Non-Responders in Various Drug Classes 120
Table 6.4: High-Profile Drug Withdrawals from the Marketplace 121
Table 6.5: Metabolism of Drugs by Hepatic Enzymes 122
Table 6.6: Drug Metabolism Drives Drug Efficacy/Toxicity 125
Table 6.7: Population Frequency of the Various Cytochromes 125
Table 6.8: Selected List of Personalized Medicine Tests 128
Table 6.9: Personalized Medicine and Companion Diagnostics Product Pipeline 131
Table 6.10: Members of the Perso
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