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ReportsnReports – Companion Diagnostics in Personalized Medicine and Cancer Therapy


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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.

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ReportsnReports – Companion Diagnostics in Personalized Medicine and Cancer Therapy

  1. 1. Companion Diagnostics in Personalized Medicine and Cancer TherapyA near-term market opportunity for cancer companion diagnostic tests exists in drugselection for cancer therapy. Co-development of molecular diagnostics and targetedtherapeutics has already been proven to be a successful strategy in the development ofnovel anti-cancer drugs. Adoption of biomarker development in clinical research providesgreat opportunities to identify patient subpopulations with differential drug responses and touncover the underlying mechanisms. These data could help to explain if clinical trials of newdrugs are adequate, and offer the possibility of creating a clear prescription path based onpredictive biomarkers.Buy Now: Personalized Medicine and Cancer Therapy MarketBrowse All: Latest Market Research ReportsThe purpose of this TriMark Publications report is to describe the specific segment of thediagnostics market that develops new technology platforms for evaluating the metabolismof therapeutic agents, or for evaluating which therapeutic regimes are most effective for aparticular type of disease.The term companion diagnostic means that the particular diagnostic test under evaluation isspecifically linked to a known therapeutic drug. This linkage could be important in thetherapeutic application and clinical outcome of a drug (personalized medicine), or animportant component of the drug development process. This report focuses on the formerlinkage, i.e., the use of companion diagnostic tests in personalized medicine.TABLE OF CONTENTS1. Overview 81.1 Statement of Report 81.2 About This Report 81.3 Scope of the Report 81.4 Objectives 91.5 Methodology 101.6 Executive Summary 112. Companion Diagnostics and Personalized Medicine 162.1 Scope of This Section 162.2 Introduction to Companion Diagnostics and Personalized Medicine 162.3 Drug Metabolism and Companion Diagnostics and Personalized Medicine 212.4 Examples of Personalized Medicine and Companion Diagnostic Tests 242.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 272.6 The Personalized Medicine Coalition (PMC) 292.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 322.7.1 The Changing Regulatory Landscape for Personalized Medicine 332.8 Companion Diagnostics Play an Increasing Role in Cancer Care 342.9 Specific Examples of Clinical Situations where Companion Diagnostics are being
  2. 2. Deployed 352.9.1 Epidermal Growth Factor Receptor (EGFR) Assay 362.9.2 Individualized Warfarin Therapy 382.9.3 UGT1A1 Molecular Assay for Camptosar 382.9.4 Response to Gleevec in GIST 382.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 392.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to EnterCompanionDiagnostics 392.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 392.11 Value Chain 402.12 Impact of CDx/PM on Drug Clinical Trials 413. Companion Diagnostics: Qualitative and Quantitative Market Analysis 433.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 433.2 Costs of Companion Diagnostics in Healthcare Expenditures 443.3 Molecular Diagnostic Market 453.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 483.5 Snapshot of Companion Diagnostics Industry Structure 493.6 The Case for Theranostics 503.7 Companion Diagnostics Market Analysis-Market Survey Data Characterizing theQualitative and Quantitative Industry Parameters 514. Trends and Overview 544.1 Companion Diagnostics: Industry SWOT Analysis 544.2 Macro Trends in Companion Diagnostics 544.3 Challenges for Companion Diagnostics Development 584.4 Timeline for Impact of Various Segments in Companion Diagnostics 604.5 Use of Proteomics to Develop Individualized Tests 624.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 635. Biomarker Tests Co-developed with Cancer Therapeutics as CompanionDiagnostics 645.1 Sector Overview 645.1.1 Impact of New Technology Platforms 645.1.2 Impact on Drug Discovery 655.1.3 Biomarkers as Endpoints in Drug Discovery 655.1.4 Targeted Therapy 665.2 Companion Diagnostics on the Market 675.3 Epidermal Growth Factor Receptor Companions 675.3.1 Bevacizamab (Avastin) 685.3.2 EGFR for Colorectal Cancer and Camptosar (Irinotecan) 695.3.2.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 695.3.2.2 Companion Diagnostic Test Developed for Bristol-Myers’s SPRYCEL 695.3.3 EGFR Express and Erbitux (Cetuximab) 695.3.4 HER2 and Heceptin (Trastuzumab) 705.3.4.1 Bayer’s Advia Centaur HER2/neu Assay 725.3.4.2 Companies Marketing HER2/neu Assays 725.3.5 Iressa and Tarceva Companion Test 72
  3. 3. 5.3.6 Tykerb (GSK), and Vectibix (Amgen) Companion Tests 725.3.7 EGFRx Assay 735.3.8 Monogram eTag 745.3.9 Veripath OncoDiagnostics EGFR PharmDX 745.3.10 NSCL Patients with EGFR Mutation 745.3.11 A Personalized Medicine Program for Chronic Myeloid Leukemia 745.4 Companions Based on Myriad’s IVDMIA Technology 745.4.1 Myriad’s TheraGuide 5-FU 745.4.2 Myriad’s BRCA Companion Dx Testing for BioMarin’s PARP Inhibitor BMN 673 755.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 755.5.1 TheraScreen: EGFR29 755.5.2 The K-RAS Mutation Detection Kit 765.6 Irinotecan and UGT1A1 765.7 Gleevec (Imatinib) Companions 765.7.1 DakoCytomation’s c-Kit (9.7) pharmDx 775.8 Companion Diagnostics Involving Metabolizing Enzymes 775.8.1 Companions for TMPT, CYP2C9 and UGT1A1 Enzymes 775.8.2 Companions for Aromatase Inhibitors 775.8.3 Companions for Actos and Avandia 785.9 Drivers and Barriers to Companion Diagnostics 785.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 795.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 795.12 Companion Diagnostics Used by Clinical Service Laboratories 805.13 New Technologies and Products under Development 815.13.1 OncoMethylome 815.14 Pharmacogenomics Tests 815.14.1 MGMT Methylation Assay 815.14.2 Other Pharmacogenomic Opportunities 825.15 Recurrence Prediction Tests 835.16 Blood-based Technologies 835.16.1 Oncotech 835.17 Monogram Biosciences HIV Personalized Platform 845.18 Wako LBAAFP Test for Liver Cancer 845.19 Future Developments for Companion Diagnostics 855.20 Drug Response Predictors 856. Business and Regulatory Trends in the Companion Biomarker Testing Sector 876.1 Industry Consolidation 876.2 Breath of Product Offering and Pricing 886.3 Government Regulation of Medical Devices 886.3.1 FDA Guidance on Drug Test Co-development 906.3.2 Device Classes 906.3.3 Investigational Use of IVDM Assays 916.3.4 Post-market Requirements 916.3.5 Voluntary versus Required Submissions 916.3.6 Examples of Recent Voluntary Genomic Data Submissions 916.3.7 FDA Labeling Implications and Rules 926.3.8 Regulatory Activities in Companion Diagnostic Testing-Translation of DiagnosticTesting Results into Clinical Practice 92
  4. 4. 6.4 Strategic Business and Marketing Considerations 936.5 Commercial Opportunities in Companion Markers 936.6 Moderators of Growth 946.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 956.6.2 Management of Targeted Therapeutics by Third-Party Payers 956.7 Biotechnology Industry Trends 956.8 Pharmaceutical Industry Trends 966.9 Acquisition, License Agreement, Partnerships 976.10 Legal Developments 1006.11 Sales and Marketing Strategies for Tumor Marker Tests 1026.11.1 International Markets 1046.11.2 Europe 1046.11.3 Central and South America 1056.11.4 Asia-Pacific 1056.12 Product Commercialization 1056.13 Reimbursement 1066.14 Self-Referral Rules 1076.15 Health Insurance Portability and Accountability Act 1086.16 Clinical Laboratory Improvement Amendments (CLIA) 1086.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 1096.18 FDA’s Quality System Regulation (QSR) 1106.19 FDA’S OIVD on IVDMIAs 1106.20 FDA’s Qualification of Cancer Biomarkers 1116.20.1 Regulatory Perspectives of Biomarker Validation 1116.21 Genetic Tests and Medical Records 1126.21.1 Laws against Genetic Discrimination 1126.22 Global Drivers of Clinical Laboratory Testing 1136.23 Global Outlook 1146.24 Oncology Biomarker Qualification Initiative 1146.25 FDA Critical Path 1156.25.1 Examples of Drugs being held up due to lack of Compliance with FDA Directives 1156.26 Biomarkers and FDA’s Voluntary Genomic Data Submission 1166.27 From Personalized to Predictive Medicine 1166.28 Analysis of Cost-Effectiveness at the Individual Level 1166.29 The Patient and Advocate Perspective: An Evolution of Influence 1166.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice1166.30.1 Evolving Business Models in Companion Dx and Personalized Medicine 1176.30.2 Current Pharm/Dx Business Model Examples 1186.31 Reimbursement and Value Creation 1186.32 What is the Role of Governmental Agencies in Driving the Adoption of CDx? 1186.33 What is the Role of the Insurance Industry in Driving the Adoption PGx? 1186.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 1196.35 FDA Guidance Document on Co-development 1196.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 1196.37 What is the Future Role of PBM’s in Laboratory Services? 1207. Companies Entering the Companion Diagnostics Market 1217.1 Industry Overview 121
  5. 5. 7.1.1 20/20 GeneSystems, Inc. 1217.1.2 Abbott Diagnostics 1217.1.3 Affymetrix 1247.1.4 Agendia BV 1267.1.5 Agensys, Inc. 1277.1.6 Almac Group 1277.1.7 Almac Diagnostics 1287.1.8 AMDL, Inc. 1287.1.9 Arcturus Bioscience, Inc. (Acquired by Molecular Devices) 1307.1.10 Aureon Laboratories Corporation 1307.1.11 Becton, Dickinson and Company 1317.1.12 Beckman Coulter, Inc. 1317.1.13 Biocode Hycel 1337.1.14 BioCurex, Inc. 1337.1.15 Biodesix 1347.1.16 Biomarker Technologies, LLC 1347.1.17 Biomedical Diagnostics, LLC 1347.1.18 Biomerica 1347.1.19 bioMerieux 1357.1.20 BioModa, Inc. 1357.1.21 Bruker Daltonics 1367.1.22 Cangen Biotechnologies, Inc. 1367.1.23 Caprion Proteomics 1377.1.24 Celera Diagnostics 1387.1.25 Cepheid 1397.1.26 Claros Diagnostics 1407.1.27 Clinical Data, Inc. 1407.1.28 Ciphergen Biosystems, Inc. (Renamed Vermillion, Inc.) 1427.1.29 Clarient, Inc. 1447.1.30 Correlogic Systems, Inc. 1457.1.31 CytoCore, Inc. 1457.1.32 Cytogen Corporation 1467.1.33 Cytyc Corporation 1497.1.34 Dako (Formerly DakoCytomation) 1507.1.35 DiaDexus 1507.1.36 Digene (Acquired by Qiagen) 1517.1.37 DiagnoCure 1517.1.38 Diagnostic Systems Laboratories, Inc. (Acquired by Beckman Coulter) 1537.1.39 DRG International 1537.1.40 DxS (Acquired by Qiagen) 1547.1.41 EDP Biotech Corporation 1557.1.42 Epigenomics 1557.1.43 EXACT Sciences Corporation 1567.1.44 Exagen Diagnostics 1577.1.45 Gene Logic, Inc. 1587.1.46 Genesis Genomics, Inc. 1597.1.47 Genomic Health 1597.1.48 Gen-Probe, Inc. 1607.1.49 Health Discovery Corporation 160
  6. 6. 7.1.50 Ikonisys, Inc. 1617.1.51 Immunicon Corporation 1617.1.52 Immunomedics 1657.1.53 Incyte 1667.1.54 InterGenetics 1677.1.55 Ipsogen 1677.1.56 Johnson & Johnson 1677.1.57 LabCorp 1687.1.58 Matritech, Inc. 1697.1.59 Miraculins 1717.1.60 Mitsubishi Kagaku latron 1727.1.61 Monogram Biosciences 1727.1.62 Myriad Genetics, Inc. 1737.1.63 NimbleGen Systems 1767.1.64 Northwest Biotherapeutics, Inc. 1767.1.65 Nycomed 1787.1.66 Oncotech, Inc. 1787.1.67 Oncothyreon (Formerly known as Biomira) 1797.1.68 Orion Genomics 1807.1.69 Oxford Genome Sciences 1807.1.70 Panacea Pharmaceuticals, Inc. 1817.1.71 Perlegen Sciences, Inc. 1817.1.72 Polymedco, Inc. 1817.1.73 Power3 Medical Products 1827.1.74 Prometheus 1827.1.75 Proteome Systems Limited 1837.1.76 Qiagen N.V. 1837.1.77 Sanko Junyaku Co. Ltd. 1847.1.78 SensiGen, LLC 1847.1.79 SuperArray Bioscience Corporation 1847.1.80 Third Wave Technologies, Inc. 1857.1.81 Tosoh Biosciences 1857.1.82 TrimGen 1857.1.83 Upstream Biosciences, Inc. 1867.1.84 Ventana Medical Systems, Inc. 1867.1.85 Veridex, LLC 187Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submission(March 2005) 188I. Introduction 188II. Background 188III. Submission Policy 189A. General Principles 189B. Specific Uses of Pharmacogenomic Data in Drug Development and Labeling 191C. Benefits of Voluntary Submissions to Sponsors and FDA 192IV. Submission of Pharmacogenomic Data 193A. Submission of Pharmacogenomic Data during the IND Phase 193B. Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement 194C. Submission to a Previously Approved NDA or BLA 195
  7. 7. D. Compliance with 21 CFR Part 58 195E. Submission of Voluntary Genomic Data from Application-Independent Research 196V. Format and Content of a VGDS 196VI. Process for Submitting Pharmacogenomic Data 197VII. Agency Review of Voluntary Genomic Data Submissions 197Glossary 200Appendix 2: Histochemical Markers for Cancer 201LIST OF FIGURESFigure 2.1: Personalizing Drug Treatment 17Figure 2.2: Approaches to Personalized Medicine 18Figure 2.3: The Phase I and II Processes of Drug Metabolism 21Figure 2.4: Hepatic Distribution of Human CYP450 22Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 22Figure 2.6: Genetic Components Determine Drug Metabolism 23Figure 2.7: Personalized Medicine Drugs in Development 27Figure 2.8: Healthcare Value Chain 41Figure 3.1: From Genetic Content to Personalized Medicine 44Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision Making 44Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 45Figure 3.4: Breakout of the Molecular Diagnostics Marketplace by Country 46Figure 3.5: Breakout of the Molecular Diagnostics Marketplace by Vendor 46Figure 3.6: Molecular Diagnostics Market Segmentation 47Figure 3.7: Molecular Diagnostics Market Segmentation by Technology 47Figure 3.8: Market Survey Respondent Demographics 52Figure 3.9: Breakout of the Respondent Pool by Affiliation 52Figure 3.10: Segmentation of the Personalized Medicine Market 53Figure 4.1: Personalized Medicine Market Drivers 55Figure 4.2: Challenges in the Personalized Medicine Space 56Figure 5.1: Carcinogenesis is a Multi-Step Process 64Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results withIHC 71Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 71Figure 5.4: MGMT Methylation Status Correlates to Survival Rate 82LIST OF TABLESTable 2.1: Timeline for Development of Companion Diagnostics 18Table 2.2: Personalized Medicine at the Nexus Point 19Table 2.3: Percentage of Non-Responders in Various Drug Classes 19Table 2.4: High-Profile Drug Withdrawals from the Marketplace 20Table 2.5: Metabolism of Drugs by Hepatic Enzymes 21Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity 24Table 2.7: Population Frequency of the Various Cytochromes 24Table 2.8: Selected List of Personalized Medicine Tests 26Table 2.9: Personalized Medicine Product Pipeline 28Table 2.10: Typical Response Rates in Therapeutic Areas 35Table 2.11: Prevalence of People Taking Medications Metabolized by Liver Enzymes 37Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan 37Table 2.13: Current Product Labels: Enzyme Metabolism 37
  8. 8. Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies onPersonalized Medicine 48Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas inPersonalized Medicine 48Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in PersonalizedMedicine 49Table 3.4: FDA Classification of Diagnostics by Risk 51Table 4.1: Personalized Medicine Industry SWOT Analysis 54Table 4.2: Market Opportunities in Personalized Medicine 57Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests 58Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development 59Table 4.5: Timeline of Impact in Areas of Personalized Medicine 60Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas 61Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics 66Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development 66Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret TestResults 70Table 5.4: Device Submission Elements for the FDA 79Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 88Table 6.2: Summary of Biomarker Use in the Commercialization of Novel OncologyPharmacotherapeutics 117Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers asCompanionDiagnostic Tests 117Table 7.1: Major Players in Companion Diagnostic Sector 121Table 7.2: Tumor Diagnosis Immunoassay 153Table 7.3: Tumor Diagnosis Radioimmunoassay 154Table 7.4: Summary of Matritech’s Product Development Programs 171Latest Market Research Reports:China Third-party Payment Industry Report, 2010-2013Global and China Wafer Foundry Industry Report, 2010-2011China Steel Structure Industry Report, 2010-2015China – Telecoms, Mobile, Broadband and ForecastsResearch Report on Chinese Railway Transport Industry, 2009-2010The Global Rare Earth Elements Market 2011-2015: Is the Hype Justified?The Future of Interior Products in Germany to 2015: Demand to Gather Pace from 2013About Us:ReportsnReports is an online library of over 75,000 market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Follow us on Twitter: Facebook Page:
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