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Companion Diagnostics in Personalized Medicine and Cancer Therapy
Publication Date: 01-APR-08
Pages: 190
Study: TMRCDPM
Format/Price: PDF document / $3,400.00

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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 TriMark 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 Exagen Diagnostics 146
7.2.43 Gene Logic 147
7.2.44 Genesis Genomics 148
7.2.45 Genomic Health 148
7.2.46 Gen-Probe 149
7.2.47 Health Discovery Corporation 149
7.2.48 Ikonisys 150
7.2.49 Immunicon 150
7.2.50 Immunomedics 154
7.2.51 Incyte 155
7.2.52 InterGenetics 155
7.2.53 Ipsogen 156
7.2.54 LabCorp 156
7.2.55 Matritech 157
7.2.56 Miraculins 160
7.2.57 Mitsubishi Kagaku latron 160
7.2.58 Monogram Biosciences 160
7.2.59 Myriad Genetics 161
7.2.60 NimbleGen Systems 164
7.2.61 Northwest Biotherapeutics 164
7.2.62 Nycomed 166
7.2.63 Oncotech 166
7.2.64 Oncothyreon (formerly known as Biomira) 167
7.2.65 Orion Genomics 168
7.2.66 Oxford Genome Sciences 168
7.2.67 Panacea Pharmaceuticals 169
7.2.68 Perlegen Sciences 169
7.2.69 Polymedco 169
7.2.70 Power3 Medical Products 170
7.2.71 Prometheus 170
7.2.72 Proteome Systems 171
7.2.73 Qiagen 171
7.2.74 Sanko Junyaku 172
7.2.75 SensiGen 172
7.2.76 SuperArray Bioscience 172
7.2.77 Third Wave Technologies 173
7.2.78 Tosoh Biosciences 173
7.2.79 TrimGen 173
7.2.80 TriPath Imaging (acquired by BD) 174
7.2.81 Upstream Biosciences 174
7.2.82 Ventana Medical Systems 174
7.2.83 Veridex 176
Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submission (March 2005) 177
Appendix 2: Histochemical Markers for Cancer 189
LIST OF TABLES
Table 2.1: Timeline for Development of Companion Diagnostics 14
Table 2.2: Personalized Medicine at the Nexus Point 15
Table 2.3: Percentage of Non-Responders in Various Drug Classes 16
Table 2.4: High-Profile Drug Withdrawals from the Marketplace 16
Table 2.5: Metabolism of Drugs by Hepatic Enzymes 18
Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity 21
Table 2.7: Population Frequency of the Various Cytochromes 21
Table 2.8: Selected List of Personalized Medicine Tests 23
Table 2.9: Personalized Medicine Product Pipeline 25
Table 2.10: Marketed Personalized Therapies in 2006 26
Table 2.11: Typical Response Rates in Therapeutic Areas 33
Table 2.12: Prevalence of People Taking Medications Metabolized by Liver Enzymes 34
Table 2.13: UGT1A1 Helps to Determine Risks Associated with Irinotecan 34
Table 2.14: Current Product Labels: Enzyme Metabolism 35
Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 43
Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 43
Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 44
Table 3.4: FDA Classification of Diagnostics by Risk 46
Table 4.1: Personalized Medicine Industry SWOT Analysis 49
Table 4.2: Market Opportunities in Personalized Medicine 51
Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests 52
Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development 53
Table 4.5: Timeline of Impact in Areas of Personalized Medicine 54
Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas 55
Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics 59
Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development 59
Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 63
Table 5.4: Device Submission Elements for the FDA 71
Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 79
Table 6.2: Medicare Spending on Clinical Lab Services, 1996 to 2005 103
Table 6.3: Hospital Laboratory Share of Part B Medicare Spending, 1996 to 2005 104
Table 6.4: Medicare Part B Lab Spending Per Medicare Enrollee, 1998 to 2005 104
Table 6.5: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics 108
Table 6.6: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests 108
Table 7.1: Major Players in Companion Diagnostic Sector 109
Table 7.2: Tumor Diagnosis Immunoassay 142
Table 7.3: Tumor Diagnosis Radioimmunoassay 143
Table 7.4: Summary of Matritech's Product Development Programs 159
LIST OF FIGURES
Figure 2.1: Personalizing Drug Treatment 13
Figure 2.2: Approaches to Personalized Medicine 14
Figure 2.3: The Phase I and II Processes of Drug Metabolism 17
Figure 2.4: Hepatic Distribution of Human CYP450 18
Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 19
Figure 2.6: Genetic Components Determine Drug Metabolism 19
Figure 2.7: Personalized Medicine Drugs in Development 24
Figure 3.1: From Genetic Content to Personalized Medicine 39
Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision Making 39
Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 40
Figure 3.4: Breakout of the Molecular Diagnostics Marketplace by Country 40
Figure 3.5: Breakout of the Molecular Diagnostics Marketplace by Vendor 41
Figure 3.6: Molecular Diagnostics Market Segmentation 42
Figure 3.7: Molecular Diagnostics Market Segmentation by Technology 42
Figure 3.8: Market Survey Respondent Demographics 46
Figure 3.9: Breakout of the Respondent Pool by Affiliation 47
Figure 3.10: Segmentation of the Personalized Medicine Market 47
Figure 4.1: Personalized Medicine Market Drivers 50
Figure 4.2: Challenges in the Personalized Medicine Space 50
Figure 5.1: Carcinogenesis Is a Multi-Step Process 57
Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 64
Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 64
Figure 5.4: MGMT Methylation Status Correlates to Survival Rate 74
Figure 6.1: Part B Spending on Clinical Lab Services, 1991 to 2005 103

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