Companion Diagnostics in Personalized Medicine and Cancer Therapy --- Aarkstore Enterprise

A near-term market opportunity for cancer companion diagnostic tests exists in drug selection for cancer therapy. Co-development of molecular diagnostics and targeted therapeutics has already been proven to be a successful strategy in the development of novel anti-cancer drugs. Adoption of biomarker development in clinical research provides great opportunities to identify patient subpopulations with differential drug responses and to uncover the underlying mechanisms. These data could help to explain if clinical trials of new drugs are adequate, and offer the possibility of creating a clear prescription path based on predictive biomarkers. The purpose of this Publications report is to describe the specific segment of the diagnostics market that develops new technology platforms for evaluating the metabolism of therapeutic agents, or for evaluating which therapeutic regimes are most effective for a particular type of disease. The term companion diagnostic means that the particular diagnostic test under evaluation is specifically linked to a known therapeutic drug. This linkage could be important in the therapeutic application and clinical outcome of a drug (personalized medicine), or an important component of the drug development process. This report focuses on the former linkage, i.e., the use of companion diagnostic tests in personalized medicine.



Table of Contents :
1 Overview 6
1.1 Statement of Report 6
1.2 About This Report 6
1.3 Scope of the Report 6
1.4 Objectives 7
1.5 Methodology 8
1.6 Executive Summary 9

2 Companion Diagnostics and Personalized Medicine 13
2.1 Scope of this Section 13
2.2 Introduction to Companion Diagnostics and Personalized Medicine 13
2.3 Drug Metabolism and Companion Diagnostics and Personalized Medicine 17
2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 21
2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 24
2.6 The Personalized Medicine Coalition (PMC) 26
2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 29
2.7.1 The Changing Regulatory Landscape for Personalized Medicine 31
2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 32
2.9 Specific Examples of Clinical Situations Where Companion Diagnostics Are Being Deployed 33
2.9.1 Epidermal Growth Factor Receptor (EGFR) Assay 33
2.9.2 Individualized Warfarin Therapy 35
2.9.3 UGT1A1 Molecular Assay for Camptosar 36
2.9.4 Response to Gleevec in GIST 36
2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 36
2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics 36
2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 37

3 Companion Diagnostics: Qualitative and Quantitative Market Analysis 38
3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 38
3.2 Costs of Companion Diagnostics in Healthcare Expenditures 39
3.3 Molecular Diagnostic Market 40
3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 42
3.5 Snapshot of Companion Diagnostics Industry Structure 44
3.6 The Case for Theranostics 45
3.7 Companion Diagnostics Market Analysis—Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 46

4 Trends and Overview 49
4.1 Companion Diagnostics: Industry SWOT Analysis 49
4.2 Macro Trends in Companion Diagnostics 49
4.3 Challenges for Companion Diagnostics Development 52
4.4 Timeline for Impact of Various Segments in Companion Diagnostics 53
4.5 Use of Proteomics to Develop Individualized Tests 55
4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 56

5 Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 57
5.1 Sector Overview 57
5.1.1 Impact of New Technology Platforms 57
5.1.2 Impact on Drug Discovery 58
5.1.3 Biomarkers as Endpoints in Drug Discovery 58
5.1.4 Targeted Therapy 59
5.2 Companion Diagnostics on the Market 60
5.3 Epidermal Growth Factor Receptor Companions 60
5.3.1 Bevacizamab (Avastin) 61
5.3.2 EGFR for Colorectal Cancer and Camptosar (Irinotecan) 62
5.3.3 EGFR Express and Erbitux (Cetuximab) 62
5.3.4 HER2 and Heceptin (Trastuzumab) 63
5.3.5 Iressa and Tarceva Companion Test 65
5.3.6 Tykerb (GSK), and Vectibix™ (Amgen) Companion Tests 65
5.3.7 EGFRx Assay 66
5.3.8 Monogram eTag 67
5.3.9 Veripath OncoDiagnostics EGFR PharmDX 67
5.4 Myriad’s TheraGuide 5-FU 67
5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 68
5.5.1 TheraScreen: EGFR29 68
5.5.2 The K-RAS Mutation Detection Kit 68
5.6 Irinotecan and UGT1A1 68
5.7 Gleevec (Imatinib) Companions 68
5.7.1 DakoCytomation’s c-Kit (9.7) pharmDx 69
5.8 Companion Diagnostics Involving Metabolizing Enzymes 69
5.8.1 Companions for TMPT, CYP2C9, and UGT1A1 Enzymes 69
5.8.2 Companions for Aromatase Inhibitors 70
5.8.3 Companions for Actos and Avandia 70
5.9 Drivers and Barriers to Companion Diagnostics 71
5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 71
5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 72
5.12 Companion Diagnostics Used by Clinical Service Laboratories 72
5.13 New Technologies and Products under Development 73
5.13.1 OncoMethylome 73
5.14 Blood-Based Technologies 75
5.14.1 Oncotech 75
5.15 Monogram Biosciences HIV Personalized Platform 76
5.16 Wako LBA\AFP Test for Liver Cancer 76
5.17 Future Developments for Companion Diagnostics 76

6 Business and Regulatory Trends in the Companion Biomarker Testing Sector 78
6.1 Industry Consolidation 78
6.2 Breath of Product Offering and Pricing 79
6.3 Government Regulation of Medical Devices 79
6.3.1 FDA Guidance on Drug Test Co-development 81
6.3.2 Device Classes 81
6.3.3 Investigational Use of IVDM Assays 81
6.3.4 Post-market Requirements 82
6.4 Strategic Business and Marketing Considerations 83
6.5 Commercial Opportunities in Companion Markers 84
6.6 Moderators of Growth 85
6.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 85
6.6.2 Management of Targeted Therapeutics by Third-Party Payers 86
6.7 Biotechnology Industry Trends 86
6.8 Pharmaceutical Industry Trends 86
6.9 Acquisition, License Agreement, Partnerships 87
6.10 Legal Developments 90
6.11 Sales and Marketing Strategies for Tumor Marker Tests 91
6.11.1 International Markets 93
6.12 Product Commercialization 94
6.13 Reimbursement 95
6.14 Self-Referral Rules 96
6.15 Health Insurance Portability and Accountability Act 97
6.16 Clinical Laboratory Improvement Amendments (CLIA) 98
6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 98
6.18 FDA’s Quality System Regulation (QSR) 99
6.19 FDA’S OIVD on IVDMIAs 99
6.20 FDA’s Qualification of Cancer Biomarkers 100
6.20.1 Regulatory Perspectives of Biomarker Validation 100
6.21 Genetic Tests and Medical Records 101
6.21.1 Laws against Genetic Discrimination 102
6.22 Medicare Reimbursement 102
6.22.1 Medicare Part B Spending Trends 102
6.23 Global Drivers of Clinical Laboratory Testing 104
6.24 Global Outlook 105
6.25 Oncology Biomarker Qualification Initiative 106
6.26 FDA Critical Path 107
6.27 Biomarkers and FDA’s Voluntary Genomic Data Submission 107
6.28 From Personalized to Predictive Medicine 107
6.29 Analysis of Cost-Effectiveness at the Individual Level 107
6.30 The Patient and Advocate Perspective: An Evolution of Influence 107
6.31 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 107

7 Companies Entering the Companion Diagnostics Market 109
7.1 Industry Overview 109
7.2 Representative Companion Diagnostic Development Companies 109
7.2.1 20/20 GeneSystems 111
7.2.2 Abbott Diagnostics 111
7.2.3 Affymetrix 114
7.2.4 Agendia BV 116
7.2.5 Agensys 117
7.2.6 Almac Group 117
7.2.7 AMDL 117
7.2.8 Arcturus Bioscience (acquired by Molecular Devices) 119
7.2.9 Aureon Laboratories 119
7.2.10 BD 120
7.2.11 Beckman Coulter 120
7.2.12 Biocode Hycel 122
7.2.13 BioCurex 122
7.2.14 Biomarker Technologies 123
7.2.15 Biomedical Diagnostics 123
7.2.16 Biomerica 123
7.2.17 bioMérieux 124
7.2.18 BioModa 124
7.2.19 Bruker Daltonics 125
7.2.20 Cangen Biotechnologies 125
7.2.21 Caprion Proteomics 126
7.2.22 Celera Diagnostics 126
7.2.23 Cepheid 128
7.2.24 Claros Diagnostics 128
7.2.25 Clinical Data: PGxHealth and Cogenics 129
7.2.26 Ciphergen Biosystems renamed Vermillion, Inc. 131
7.2.27 Clarient 133
7.2.28 Correlogic Systems 134
7.2.29 CytoCore 134
7.2.30 Cytogen 134
7.2.31 Cytyc Corporation 138
7.2.32 Dako (formerly DakoCytomation) 138
7.2.33 DiaDexus 139
7.2.34 Digene (acquired by Qiagen) 140
7.2.35 DiagnoCure 140
7.2.36 Diagnostic Systems Laboratories (acquired by Beckman Coulter) 141
7.2.37 DRG International 142
7.2.38 DxS 143
7.2.39 EDP Biotech 144
7.2.40 Epigenomics 144
7.2.41 EXACT Sciences Corporation 145
7.2.42 Exage

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