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

panion Diagnostics 65
4.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 66
4.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 66
4.12 Companion Diagnostics Used by Clinical Service Laboratories 67
4.13 New Technologies and Products under Development 68
4.13.1 MDx Health 69
4.13.2 Ventana to Collaborate with Pfizer and CST on Companion Diagnostic to Identify Lung Cancer Patients with ALK Gene Rearrangements 70
4.13.3 Abbott and Merck Collaborate to Develop Companion Diagnostic Test for Investigational Cancer
Therapy 70
4.14 Pharmacogenomics Tests 71
4.14.1 MGMT Methylation Assay 71
4.14.2 Other Pharmacogenomic Opportunities 72
4.15 Recurrence Prediction Tests 73
4.16 Blood-Based Technologies 73
4.16.1 Oncotech, Inc. 73
4.17 Monogram Biosciences HIV Personalized Platform 74
4.18 Wako LBA AFP Test for Liver Cancer 74
4.19 Future Developments for Companion Diagnostics 74
4.20 Drug Response Predictors 76

5. Business and Regulatory Trends in the Companion Biomarker Testing Sector 77
5.1 Industry Consolidation 77
5.2 Breath of Product Offering and Pricing 78
5.3 Government Regulation of Medical Devices 78
5.3.1 FDA Guidance on Drug Test Co-development 80

5.3.2 Device Classes 80
5.3.3 Investigational Use of IVDMIAs 81
5.3.4 Post-Market Requirements 81
5.3.5 Voluntary vs. Required Submissions 82
5.3.6 Examples of Recent Voluntary Genomic Data Submissions 82
5.3.7 FDA Labeling Implications and Rules 82
5.3.8 Regulatory Activities in Companion Diagnostic Testing—Translation of Diagnostic Testing Results into Clinical Practice 83
5.4 Strategic Business and Marketing Considerations 83
5.5 Commercial Opportunities in Companion Markers 83
5.6 Moderators of Growth 85
5.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 86
5.6.2 Management of Targeted
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1. Ventana paves the way for companion diagnostic early phase clinical trials in China to advance patient care
2. QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients
3. Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment
4. Ventana announces HER2 companion diagnostic to identify breast cancer patients for Roches latest targeted medicines, Perjeta and Kadcyla
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