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Companion Diagnostics in Personalized Medicine and Cancer Therapy

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 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

• 1Overview6
  • 1.1Statement of Report6
  • 1.2About This Report6
  • 1.3Scope of the Report6
  • 1.4Objectives7
  • 1.5Methodology8
  • 1.6Executive Summary9
  
  
• 2Companion Diagnostics and Personalized Medicine13
  • 2.1Scope of this Section13
  • 2.2Introduction to Companion Diagnostics and Personalized Medicine13
  • 2.3Drug Metabolism and Companion Diagnostics and Personalized Medicine17
  • 2.4Examples of Personalized Medicine and Companion Diagnostic Tests21
  • 2.5Personalized Medicine and Companion Diagnostic Testing Product Pipeline24
  • 2.6The Personalized Medicine Coalition (PMC)26
  • 2.7Regulatory Trends and Guidelines in the Personalized Medicine Space29
    • 2.7.1The Changing Regulatory Landscape for Personalized Medicine31
  • 2.8Companion Diagnostics Play an Increasing Role in Cancer Care32
  • 2.9Specific Examples of Clinical Situations Where Companion Diagnostics Are Being Deployed33
    • 2.9.1Epidermal Growth Factor Receptor (EGFR) Assay33
    • 2.9.2Individualized Warfarin Therapy35
    • 2.9.3UGT1A1 Molecular Assay for Camptosar36
    • 2.9.4Response to Gleevec in GIST36
    • 2.9.5LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases36
    • 2.9.6Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics36
  • 2.10Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness37
  
  
• 3Companion Diagnostics: Qualitative and Quantitative Market Analysis38
  • 3.1Market Analysis of Molecular Diagnostics and Companion Diagnostics38
  • 3.2Costs of Companion Diagnostics in Healthcare Expenditures39
  • 3.3Molecular Diagnostic Market40
  • 3.4Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine42
  • 3.5Snapshot of Companion Diagnostics Industry Structure44
  • 3.6The Case for Theranostics45
  • 3.7Companion Diagnostics Market Analysis-Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters46
  
  
• 4Trends and Overview49
  • 4.1Companion Diagnostics: Industry SWOT Analysis49
  • 4.2Macro Trends in Companion Diagnostics49
  • 4.3Challenges for Companion Diagnostics Development52
  • 4.4Timeline for Impact of Various Segments in Companion Diagnostics53
  • 4.5Use of Proteomics to Develop Individualized Tests55
  • 4.6The Market Problem: Finding Value with Diagnostics for Personalized Medicine56
  
  
• 5Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics57
  • 5.1Sector Overview57
    • 5.1.1Impact of New Technology Platforms57
    • 5.1.2Impact on Drug Discovery58
    • 5.1.3Biomarkers as Endpoints in Drug Discovery58
    • 5.1.4Targeted Therapy59
  • 5.2Companion Diagnostics on the Market60
  • 5.3Epidermal Growth Factor Receptor Companions60
    • 5.3.1Bevacizamab (Avastin)61
    • 5.3.2EGFR for Colorectal Cancer and Camptosar (Irinotecan)62
    • 5.3.3EGFR Express and Erbitux (Cetuximab)62
    • 5.3.4HER2 and Heceptin (Trastuzumab)63
    • 5.3.5Iressa and Tarceva Companion Test65
    • 5.3.6Tykerb (GSK), and Vectibix™ (Amgen) Companion Tests65
    • 5.3.7EGFRx Assay66
    • 5.3.8Monogram eTag67
    • 5.3.9Veripath OncoDiagnostics EGFR PharmDX67
  • 5.4Myriad\'s TheraGuide 5-FU67
  • 5.5Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib68
    • 5.5.1TheraScreen: EGFR2968
    • 5.5.2The K-RAS Mutation Detection Kit68
  • 5.6Irinotecan and UGT1A168
  • 5.7Gleevec (Imatinib) Companions68
    • 5.7.1DakoCytomation\'s c-Kit (9.7) pharmDx69
  • 5.8Companion Diagnostics Involving Metabolizing Enzymes69
    • 5.8.1Companions for TMPT, CYP2C9, and UGT1A1 Enzymes69
    • 5.8.2Companions for Aromatase Inhibitors70
    • 5.8.3Companions for Actos and Avandia70
  • 5.9Drivers and Barriers to Companion Diagnostics71
  • 5.10Partnerships with Pharma Companies to Identify Therapeutic Targets71
  • 5.11Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer72
  • 5.12Companion Diagnostics Used by Clinical Service Laboratories72
  • 5.13New Technologies and Products under Development73
    • 5.13.1OncoMethylome73
  • 5.14Blood-Based Technologies75
    • 5.14.1Oncotech75
  • 5.15Monogram Biosciences HIV Personalized Platform76
  • 5.16Wako LBA\\AFP Test for Liver Cancer76
  • 5.17Future Developments for Companion Diagnostics76
  
  
• 6Business and Regulatory Trends in the Companion Biomarker Testing Sector78
  • 6.1Industry Consolidation78
  • 6.2Breath of Product Offering and Pricing79
  • 6.3Government Regulation of Medical Devices79
    • 6.3.1FDA Guidance on Drug Test Co-development81
    • 6.3.2Device Classes81
    • 6.3.3Investigational Use of IVDM Assays81
    • 6.3.4Post-market Requirements82
  • 6.4Strategic Business and Marketing Considerations83
  • 6.5Commercial Opportunities in Companion Markers84
  • 6.6Moderators of Growth85
    • 6.6.1Roadblocks to Integrating Companion Biomarkers into Clinical Practice85
    • 6.6.2Management of Targeted Therapeutics by Third-Party Payers86
  • 6.7Biotechnology Industry Trends86
  • 6.8Pharmaceutical Industry Trends86
  • 6.9Acquisition, License Agreement, Partnerships87
  • 6.10Legal Developments90
  • 6.11Sales and Marketing Strategies for Tumor Marker Tests91
    • 6.11.1International Markets93
  • 6.12Product Commercialization94
  • 6.13Reimbursement95
  • 6.14Self-Referral Rules96
  • 6.15Health Insurance Portability and Accountability Act97
  • 6.16Clinical Laboratory Improvement Amendments (CLIA)98
  • 6.17In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations98
  • 6.18FDA\'s Quality System Regulation (QSR)99
  • 6.19FDA\'S OIVD on IVDMIAs99
  • 6.20FDA\'s Qualification of Cancer Biomarkers100
    • 6.20.1Regulatory Perspectives of Biomarker Validation100
  • 6.21Genetic Tests and Medical Records101
    • 6.21.1Laws against Genetic Discrimination102
  • 6.22Medicare Reimbursement102
    • 6.22.1Medicare Part B Spending Trends102
  • 6.23Global Drivers of Clinical Laboratory Testing104
  • 6.24Global Outlook105
  • 6.25Oncology Biomarker Qualification Initiative106
  • 6.26FDA Critical Path107
  • 6.27Biomarkers and FDA\'s Voluntary Genomic Data Submission107
  • 6.28From Personalized to Predictive Medicine107
  • 6.29Analysis of Cost-Effectiveness at the Individual Level107
  • 6.30The Patient and Advocate Perspective: An Evolution of Influence107
  • 6.31Real-World Experiences Translating the Vision of Personalized Medicine into Practice107
  
  
• 7Companies Entering the Companion Diagnostics Market109
  • 7.1Industry Overview109
  • 7.2Representative Companion Diagnostic Development Companies109
    • 7.2.120/20 GeneSystems111
    • 7.2.2Abbott Diagnostics111
    • 7.2.3Affymetrix114
    • 7.2.4Agendia BV116
    • 7.2.5Agensys117
    • 7.2.6Almac Group117
    • 7.2.7AMDL117
    • 7.2.8Arcturus Bioscience (acquired by Molecular Devices)119
    • 7.2.9Aureon Laboratories119
    • 7.2.10BD120
    • 7.2.11Beckman Coulter120
    • 7.2.12Biocode Hycel122
    • 7.2.13BioCurex122
    • 7.2.14Biomarker Technologies123
    • 7.2.15Biomedical Diagnostics123
    • 7.2.16Biomerica123
    • 7.2.17bioMérieux124
    • 7.2.18BioModa124
    • 7.2.19Bruker Daltonics125
    • 7.2.20Cangen Biotechnologies125
    • 7.2.21Caprion Proteomics126
    • 7.2.22Celera Diagnostics126
    • 7.2.23Cepheid128
    • 7.2.24Claros Diagnostics128
    • 7.2.25Clinical Data: PGxHealth and Cogenics129
    • 7.2.26Ciphergen Biosystems renamed Vermillion, Inc.131
    • 7.2.27Clarient133
    • 7.2.28Correlogic Systems134
    • 7.2.29CytoCore134
    • 7.2.30Cytogen134
    • 7.2.31Cytyc Corporation138
    • 7.2.32Dako (formerly DakoCytomation)138
    • 7.2.33DiaDexus139
    • 7.2.34Digene (acquired by Qiagen)140
    • 7.2.35DiagnoCure140
    • 7.2.36Diagnostic Systems Laboratories (acquired by Beckman Coulter)141
    • 7.2.37DRG International142
    • 7.2.38DxS143
    • 7.2.39EDP Biotech144
    • 7.2.40Epigenomics144
    • 7.2.41EXACT Sciences Corporation145
    • 7.2.42Exagen Diagnostics146
    • 7.2.43Gene Logic147
    • 7.2.44Genesis Genomics148
    • 7.2.45Genomic Health148
    • 7.2.46Gen-Probe149
    • 7.2.47Health Discovery Corporation149
    • 7.2.48Ikonisys150
    • 7.2.49Immunicon150
    • 7.2.50Immunomedics154
    • 7.2.51Incyte155
    • 7.2.52InterGenetics155
    • 7.2.53Ipsogen156
    • 7.2.54LabCorp156
    • 7.2.55Matritech157
    • 7.2.56Miraculins160
    • 7.2.57Mitsubishi Kagaku latron160
    • 7.2.58Monogram Biosciences160
    • 7.2.59Myriad Genetics161
    • 7.2.60NimbleGen Systems164
    • 7.2.61Northwest Biotherapeutics164
    • 7.2.62Nycomed166
    • 7.2.63Oncotech166
    • 7.2.64Oncothyreon (formerly known as Biomira)167
    • 7.2.65Orion Genomics168
    • 7.2.66Oxford Genome Sciences168
    • 7.2.67Panacea Pharmaceuticals169
    • 7.2.68Perlegen Sciences169
    • 7.2.69Polymedco169
    • 7.2.70Power3 Medical Products170
    • 7.2.71Prometheus170
    • 7.2.72Proteome Systems171
    • 7.2.73Qiagen171
    • 7.2.74Sanko Junyaku172
    • 7.2.75SensiGen172
    • 7.2.76SuperArray Bioscience172
    • 7.2.77Third Wave Technologies173
    • 7.2.78Tosoh Biosciences173
    • 7.2.79TrimGen173
    • 7.2.80TriPath Imaging (acquired by BD)174
    • 7.2.81Upstream Biosciences174
    • 7.2.82Ventana Medical Systems174
    • 7.2.83Veridex176
    
    

 

Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submission (March 2005)177

Appendix 2: Histochemical Markers for Cancer189

LIST OF TABLES

Table 2.1: Timeline for Development of Companion Diagnostics14

Table 2.2: Personalized Medicine at the Nexus Point15

Table 2.3: Percentage of Non-Responders in Various Drug Classes16

Table 2.4: High-Profile Drug Withdrawals from the Marketplace16

Table 2.5: Metabolism of Drugs by Hepatic Enzymes18

Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity21

Table 2.7: Population Frequency of the Various Cytochromes21

Table 2.8: Selected List of Personalized Medicine Tests23

Table 2.9: Personalized Medicine Product Pipeline25

Table 2.10: Marketed Personalized Therapies in 200626

Table 2.11: Typical Response Rates in Therapeutic Areas33

Table 2.12: Prevalence of People Taking Medications Metabolized by Liver Enzymes34

Table 2.13: UGT1A1 Helps to Determine Risks Associated with Irinotecan34

Table 2.14: Current Product Labels: Enzyme Metabolism35

Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine43

Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine43

Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine44

Table 3.4: FDA Classification of Diagnostics by Risk46

Table 4.1: Personalized Medicine Industry SWOT Analysis49

Table 4.2: Market Opportunities in Personalized Medicine51

Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests52

Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development53

Table 4.5: Timeline of Impact in Areas of Personalized Medicine54

Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas55

Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics59

Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development59

Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results63

Table 5.4: Device Submission Elements for the FDA71

Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests79

Table 6.2: Medicare Spending on Clinical Lab Services, 1996 to 2005103

Table 6.3: Hospital Laboratory Share of Part B Medicare Spending, 1996 to 2005104

Table 6.4: Medicare Part B Lab Spending Per Medicare Enrollee, 1998 to 2005104

Table 6.5: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics108

Table 6.6: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests108

Table 7.1: Major Players in Companion Diagnostic Sector109

Table 7.2: Tumor Diagnosis Immunoassay142

Table 7.3: Tumor Diagnosis Radioimmunoassay143

Table 7.4: Summary of Matritech\'s Product Development Programs159

LIST OF FIGURES

Figure 2.1: Personalizing Drug Treatment13

Figure 2.2: Approaches to Personalized Medicine14

Figure 2.3: The Phase I and II Processes of Drug Metabolism17

Figure 2.4: Hepatic Distribution of Human CYP45018

Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism19

Figure 2.6: Genetic Components Determine Drug Metabolism19

Figure 2.7: Personalized Medicine Drugs in Development24

Figure 3.1: From Genetic Content to Personalized Medicine39

Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision Making39

Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending40

Figure 3.4: Breakout of the Molecular Diagnostics Marketplace by Country40

Figure 3.5: Breakout of the Molecular Diagnostics Marketplace by Vendor41

Figure 3.6: Molecular Diagnostics Market Segmentation42

Figure 3.7: Molecular Diagnostics Market Segmentation by Technology42

Figure 3.8: Market Survey Respondent Demographics46

Figure 3.9: Breakout of the Respondent Pool by Affiliation47

Figure 3.10: Segmentation of the Personalized Medicine Market47

Figure 4.1: Personalized Medicine Market Drivers50

Figure 4.2: Challenges in the Personalized Medicine Space50

Figure 5.1: Carcinogenesis Is a Multi-Step Process57

Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC64

Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH64

Figure 5.4: MGMT Methylation Status Correlates to Survival Rate74

Figure 6.1: Part B Spending on Clinical Lab Services, 1991 to 2005103

 

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