Perla Group International Inc (PERL) 0.0070 $PERL
Companion Diagnostics in Personalized Medicine and Cancer Therapy
M2 - Mon Jul 07, 8:04AM CDT
Research and Markets (http://www.researchandmarkets.com/research/35n4zz/companion) has announced the addition of the "Companion Diagnostics in Personalized Medicine and Cancer Therapy" report to their offering. Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included. Key Topics Covered: 1. Overview 1.1 Statement of Report 1.2 About This Report 1.3 Scope of the Report 1.4 Objectives 1.5 Methodology 1.6 Executive Summary 2. Companion Diagnostics and Personalized Medicine 2.1 Scope of This Section 2.2 Introduction to Companion Diagnostics and Personalized Medicine 2.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine 2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 2.6 The Personalized Medicine Coalition (PMC) 2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 2.7.1 The Changing Regulatory Landscape for Personalized Medicine 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 2.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 2.9.1 Epidermal Growth Factor Receptor Assay 2.9.2 Individualized Warfarin Therapy 2.9.3 UGT1A1 Molecular Assay for Camptosar 2.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics 2.9.7 Roche's Metastatic Melanoma Treatment, Zelboraf (vemurafenib) 2.9.8 Abbott's Late-Stage NSCLC Treatment, Xalkori (crizotinib) 2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 2.11 Value Chain 2.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 3. Companion Diagnostics: Qualitative and Quantitative Market Analysis 3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 3.2 Costs of Companion Diagnostics in Healthcare Expenditures 3.3 Molecular Diagnostic Market 3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 3.5 Snapshot of Companion Diagnostics Industry Structure 3.6 The Case for Theranostics 3.7 Companion Diagnostics Market Analysis Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 4. Trends and Overview 4.1 Companion Diagnostics: Industry SWOT Analysis 4.2 Macro Trends in Companion Diagnostics 4.3 Challenges for Companion Diagnostics Development 4.4 Timeline for Impact of Various Segments in Companion Diagnostics 4.5 Use of Proteomics to Develop Individualized Tests 4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 5.1 Sector Overview 5.1.1 Impact of New Technology Platforms 5.1.2 Impact on Drug Discovery 5.1.3 Biomarkers as Endpoints in Drug Discovery 5.1.4 Targeted Therapy 5.2 Companion Diagnostics on the Market 5.3 Epidermal Growth Factor Receptor Companions 5.3.1 Bevacizamab (Avastin) 5.3.2 EGFR for CRC and Camptosar (Irinotecan) 5.3.2.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 5.3.2.2 Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL 5.3.3 EGFR Express and Erbitux (Cetuximab) 5.3.4 HER2 and Heceptin (Trastuzumab) 5.3.4.1 Bayer's Advia Centaur HER2/neu Assay 5.3.4.2 Companies Marketing HER2/neu Assays 5.3.5 Iressa and Tarceva Companion Test 5.3.6 Tykerb (GlaxoSmithKline (GSK)) and Vectibix (Amgen) Companion Tests 5.3.7 EGFRx Assay 5.3.8 Monogram eTag 5.3.9 Veripath OncoDiagnostics EGFR PharmDX 5.3.10 NSCLC Patients with EGFR Mutation 5.3.11 A Personalized Medicine Program for CML 5.4 Companions Based on Myriad's IVDMIA Technology 5.4.1 Myriad's TheraGuide 5-FU 5.4.2 Myriad's BRCA Companion Diagnostics Testing for BioMarin's PARP Inhibitor BMN 673 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 5.5.1 TheraScreen: EGFR29 5.5.2 The K-RAS Mutation Detection Kit 5.6 Irinotecan and UGT1A1 5.7 Gleevec (Imatinib) Companions 5.7.1 DakoCytomation's c-Kit (9.7) pharmDx 5.8 Companion Diagnostics Involving Metabolizing Enzymes 5.8.1 Companions for TMPT, CYP2C9 and UGT1A1 Enzymes 5.8.2 Companions for Aromatase Inhibitors 5.8.3 Companions for Actos and Avandia 5.9 Drivers and Barriers to Companion Diagnostics 5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 5.12 Companion Diagnostics Used by Clinical Service Laboratories 5.13 New Technologies and Products under Development 5.13.1 OncoMethylome (now MDx Health) 5.13.2 Ventana Medical Systems Inks Companion Diagnostic Deal with Syndax for Lung Cancer Drug 5.13.3 Abbott Expands Agreement with GSK to Include Development of a Companion Diagnostic Test for the PRAME Antigen 5.14 Pharmacogenomics Tests 5.14.1 MGMT Methylation Assay 5.14.2 Other Pharmacogenomic Opportunities 5.15 Recurrence Prediction Tests 5.16 Blood-based Technologies 5.16.1 Oncotech 5.17 Monogram Biosciences HIV Personalized Platform 5.18 Wako LBA\AFP Test for Liver Cancer 5.19 Future Developments for Companion Diagnostics 5.20 Drug Response Predictors 6. Business and Regulatory Trends in the Companion Biomarker Testing Sector 6.1 Industry Consolidation 6.2 Breath of Product Offering and Pricing 6.3 Government Regulation of Medical Devices 6.3.1 FDA Guidance on Drug Test Co-development 6.3.2 Device Classes 6.3.3 Investigational Use of IVDMIAs 6.3.4 Post-market Requirements 6.3.5 Voluntary versus Required Submissions 6.3.6 Examples of Recent Voluntary Genomic Data Submissions 6.3.7 FDA Labeling Implications and Rules 6.3.8 Regulatory Activities in Companion Diagnostic Testing Translation of Diagnostic Testing Results into Clinical Practice 6.4 Strategic Business and Marketing Considerations 6.5 Commercial Opportunities in Companion Markers 6.6 Moderators of Growth 6.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 6.6.2 Management of Targeted Therapeutics by Third-Party Payers 6.7 Biotechnology Industry Trends 6.8 Pharmaceutical Industry Trends 6.9 Acquisition, License Agreement, Partnerships 6.10 Legal Developments 6.11 Sales and Marketing Strategies for Tumor Marker Tests 6.11.1 International Markets 6.11.2 Europe 6.11.3 Central and South America 6.11.4 Asia-Pacific 6.12 Product Commercialization 6.13 Reimbursement 6.14 Self-Referral Rules 6.15 Health Insurance Portability and Accountability Act 6.16 Clinical Laboratory Improvement Amendments (CLIA) 6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 6.18 FDA's Quality System Regulation (QSR) 6.19 The FDA's OIVD on IVDMIAs 6.20 FDA's Qualification of Cancer Biomarkers 6.20.1 Regulatory Perspectives of Biomarker Validation 6.21 Genetic Tests and Medical Records 6.21.1 Laws against Genetic Discrimination 6.22 Global Drivers of Clinical Laboratory Testing 6.23 Global Outlook 6.24 Oncology Biomarker Qualification Initiative 6.25 FDA Critical Path 6.25.1 Examples of Drugs being Hindered due to Lack of Compliance with FDA Directives 6.26 Biomarkers and FDA's Voluntary Genomic Data Submission 6.27 From Personalized to Predictive Medicine 6.28 Analysis of Cost-Effectiveness at the Individual Level 6.29 The Patient and Advocate Perspective: An Evolution of Influence 6.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 6.30.1 Evolving Business Models in Companion Diagnostics and Personalized Medicine 6.30.2 Current Pharma/Diagnostics Business Model Examples 6.31 Reimbursement and Value Creation 6.32 What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics? 6.33 What is the Role of the Insurance Industry in Driving the Adoption of pharmacogenomics (PGx)? 6.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 6.35 FDA Guidance Document on Co-development 6.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 6.37 What is the Future Role of PBMs in Laboratory Services? 7. Companies Entering the Companion Diagnostics Market 7.1 Industry Overview 7.1.1 20/20 GeneSystems, Inc. 7.1.2 Abbott Molecular, Inc. 7.1.3 Affymetrix, Inc. 7.1.4 Agendia BV 7.1.5 Agensys, Inc. 7.1.6 Agilent Technologies 7.1.7 Almac Group 7.1.8 AMDL, Inc. 7.1.9 Applied Biosystems 7.1.10 Asuragen, Inc. 7.1.11 Aureon Laboratories Corporation 7.1.12 Beckman Coulter, Inc. 7.1.13 Becton, Dickinson and Company (BD) Diagnostics - TriPath 7.1.14 Biocode Hycel 7.1.15 BioCurex, Inc. 7.1.16 Biodesix 7.1.17 Biomarker Technologies, LLC 7.1.18 Biomedical Diagnostics, LLC 7.1.19 Biomerica 7.1.20 bioM?rieux, Inc. 7.1.21 Biomira, Inc. 7.1.22 BioModa, Inc. 7.1.23 Bruker Daltonics 7.1.24 Byk Gulden 7.1.25 Cangen Biotechnologies, Inc. 7.1.26 Caprion Proteomics 7.1.27 Celera Diagnostics 7.1.28 Cepheid, Inc. 7.1.29 Clarient, Inc. 7.1.30 Claros Diagnostics 7.1.31 Clinical Data, Inc.: PGxHealth and Cogenics 7.1.32 Correlogic Systems, Inc. 7.1.33 CytoCore, Inc. (Formerly Known As Molecular Diagnostics, Inc.) 7.1.34 Cytogen Corporation (now EUSA Pharma) 7.1.35 Dako (Formerly DakoCytomation) 7.1.36 DiaDexus 7.1.37 DiagnoCure 7.1.38 DRG International 7.1.39 EDP Biotech Corporation 7.1.40 Eisai Co., Ltd. 7.1.41 Epigenomics 7.1.42 EXACT Sciences Corporation 7.1.43 Exagen Diagnostics 7.1.44 Gene Logic, Inc. 7.1.45 Genesis Genomics, Inc. (now known as Mitomics) 7.1.46 GenMark Diagnostics 7.1.47 Genomic Health 7.1.48 Gen-Probe, Inc. 7.1.49 Health Discovery Corporation 7.1.50 Hologic, Inc. (Formerly Cytyc Corporation) 7.1.51 Ikonisys, Inc. 7.1.52 Illumina 7.1.53 Immunomedics 7.1.54 Incyte 7.1.55 InterGenetics 7.1.56 Ipsogen 7.1.57 Johnson & Johnson 7.1.58 LabCorp 7.1.59 Life Technologies Corporation 7.1.60 Matritech, Inc. 7.1.61 Miraculins 7.1.62 Mitsubishi Kagaku latron 7.1.63 Monogram Biosciences (formerly ViroLogic Inc.) 7.1.64 Myriad Genetics, Inc. 7.1.65 NimbleGen Systems 7.1.66 Northwest Biotherapeutics, Inc. 7.1.67 Novartis MDx 7.1.68 Nycomed 7.1.69 Oncotech, Inc. 7.1.70 Oncothyreon, Inc. (Formerly known as Biomira) 7.1.71 Orion Genomics 7.1.72 Oxford BioTherapeutics (formerly Oxford Genome Sciences) 7.1.73 Panacea Pharmaceuticals, Inc. 7.1.74 Polymedco, Inc. 7.1.75 Power3 Medical Products 7.1.76 Prometheus 7.1.77 Proteome Systems Limited 7.1.78 Qiagen N.V. 7.1.79 Roche Molecular Diagnostics 7.1.80 Sanko Junyaku Co. Ltd. 7.1.81 SensiGen, LLC 7.1.82 Siemens Healthcare Diagnostics, Inc. 7.1.83 SuperArray Bioscience Corporation 7.1.84 Third Wave Technologies, Inc. (now owned by Hologic) 7.1.85 Tosoh Biosciences 7.1.86 TrimGen 7.1.87 Upstream Biosciences, Inc. 7.1.88 Ventana Medical Systems, Inc. 7.1.89 Veridex, LLC 7.1.90 Vermillion, Inc. (Formerly Ciphergen) 7.1.91 Vertex Pharmaceuticals, Inc. Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions A1.1 Introduction A1.2 Background A1.3 Submission Policy A1.3.1 General Principles A1.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling A1.3.3 Benefits of Voluntary Submissions to Sponsors and FDA A1.4 Submission of Pharmacogenomic Data A1.4.1 Submission of Pharmacogenomic Data During the IND Phase A1.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement A1.4.3 Submission to a Previously Approved NDA or BLA A1.4.4 Compliance with 21 CFR Part 58 A1.4.5 Submission of Voluntary Genomic Data from Application-Independent Research A1.5 Format and Content of a VGDS A1.6 Process for Submitting Pharmacogenomic Data A1.7 Agency Review of VGDSs Appendix 2: FDA Issues Draft Companion Diagnostic Guidance Appendix 3: Histochemical Markers for Cancer Glossary INDEX OF FIGURES Figure 2.1: Personalizing Drug Treatment 18 Figure 2.2: Approaches to Personalized Medicine 19 Figure 2.3: The Phase I and II Processes of Drug Metabolism 22 Figure 2.4: Hepatic Distribution of Human CYP450 23 Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 24 Figure 2.6: Genetic Components Determine Drug Metabolism 24 Figure 2.7: Personalized Medicine Drugs in Development 29 Figure 2.8: Healthcare Value Chain 49 Figure 3.1: From Genetic Content to Personalized Medicine 52 Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making 52 Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 53 Figure 3.4: Breakout of the Molecular Diagnostics Marketplace 54 Figure 3.5: Molecular Diagnostics Market Segmentation 55 Figure 3.6: Molecular Diagnostics Market Segmentation by Technology 55 Figure 3.7: Market Survey Respondent Demographics 60 Figure 3.8: Breakout of the Respondent Pool by Affiliation 60 Figure 3.9: Segmentation of the Personalized Medicine Market 61 Figure 4.1: Personalized Medicine Market Drivers 63 Figure 4.2: Challenges in the Personalized Medicine Space 64 Figure 5.1: Carcinogenesis is a Multi-Step Process 72 Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 79 Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 79 Figure 7.1: Epigenomics Product Development Pipeline 163 INDEX OF TABLES Table 2.1: Timeline for Development of Companion Diagnostics 19 Table 2.2: Personalized Medicine at the Nexus Point 20 Table 2.3: Percentage of Non-Responders in Various Drug Classes 21 Table 2.4: High-Profile Drug Withdrawals from the Marketplace 21 Table 2.5: Metabolism of Drugs by Hepatic Enzymes 23 Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity 25 Table 2.7: Population Frequency of the Various Cytochromes 26 Table 2.8: Selected List of Personalized Medicine Tests 28 Table 2.9: Personalized Medicine and Companion Diagnostics Product Pipeline 30 Table 2.10: Typical Response Rates in Therapeutic Areas 42 Table 2.11: Prevalence of People Taking Medications Metabolized by Liver Enzymes 43 Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan 45 Table 2.13: Current Product Labels: Enzyme Metabolism 45 Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 56 Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 56 Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 57 Table 3.4: FDA Classification of Diagnostics by Risk 59 Table 4.1: Personalized Medicine Industry SWOT Analysis 62 Table 4.2: Market Opportunities in Personalized Medicine 65 Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests 66 Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development 67 Table 4.5: Timeline of Impact in Areas of Personalized Medicine 68 Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas 69 Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics 74 Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development 74 Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 78 Table 5.4: Device Submission Elements for the FDA 87 Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 95 Table 6.2: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics 123 Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests 123 Table 7.1: Major Players in Companion Diagnostics Sector 127 Table 7.2: Opportunities for Biomarkers in Cancer Diagnosis and Treatment 152 Table 7.3: Tumor Diagnosis Immunoassay 161 Table 7.4: Tumor Diagnosis Radioimmunoassay 162 Table 7.5: Summary of Matritech's Product Development Programs 179 Companies Mentioned - 20/20 GeneSystems - Abbott Diagnostics - Affymetrix - Agendia BV - Agensys - Almac Group - AMDL - Arcturus Bioscience - Aureon Biosciences - Beckman Coulter - Biocode S.A. - BioCurex - Biomarker Technologies - Biomedical Diagnostics - Biomerica - bioM?rieux - Biomira - BioModa - Bruker Daltonics - Byk Gulden - Cangen Biotechnologies - Caprion Proteomics - Celera Diagnostics - Cepheid - Claros Diagnostics - Clinical Data: PGxHealth and Cogenics - Ciphergen Biosystems - Clarient - Correlogic Systems - Cytogen - Cytyc Corporation - Dako - DiaDexus LLC - Digene Corporation - DiagnoCure - Diagnostic Systems Laboratories - DRG International - DxS - EDP Biotech - Epigenomics - Exact Sciences Corporation - Exagen Diagnostics - Gene Logic - Genesis Genomics - Genomic Health - Gen-Probe - Health Discovery Corporation - Ikonisys - Immunicon - Immunomedics - Incyte Pharmaceuticals - InterGenetics - Ipsogen - LabCorp - Matritech - Miraculins - Mitsubishi Kagaku Medical - Molecular Diagnostics (CytoCore) - Monogram Biosciences - Myriad Genetics - NimbleGen Systems - Northwest Biotherapeutics - Oncotech - Orion Genomics - Oxford Genome Sciences - Panacea Pharmaceuticals - Perlegen Sciences - Polymedco - Power3 Medical Products - Prometheus - Proteome Systems - Qiagen - Sanko Junyaku - SensiGen - SuperArray Bioscience - Third Wave Technologies - Tosoh Medics - TrimGen - TriPath Imaging - Upstream Biosciences - Ventana Medical Systems - Veridex For more information visit http://www.researchandmarkets.com/research/35n4zz/companion About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. 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Companion Diagnostics in Personalized Medicine and Cancer Therapy
M2 - Mon Jul 07, 8:04AM CDT
Research and Markets (http://www.researchandmarkets.com/research/35n4zz/companion) has announced the addition of the "Companion Diagnostics in Personalized Medicine and Cancer Therapy" report to their offering. Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included. Key Topics Covered: 1. Overview 1.1 Statement of Report 1.2 About This Report 1.3 Scope of the Report 1.4 Objectives 1.5 Methodology 1.6 Executive Summary 2. Companion Diagnostics and Personalized Medicine 2.1 Scope of This Section 2.2 Introduction to Companion Diagnostics and Personalized Medicine 2.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine 2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 2.6 The Personalized Medicine Coalition (PMC) 2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 2.7.1 The Changing Regulatory Landscape for Personalized Medicine 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 2.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 2.9.1 Epidermal Growth Factor Receptor Assay 2.9.2 Individualized Warfarin Therapy 2.9.3 UGT1A1 Molecular Assay for Camptosar 2.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics 2.9.7 Roche's Metastatic Melanoma Treatment, Zelboraf (vemurafenib) 2.9.8 Abbott's Late-Stage NSCLC Treatment, Xalkori (crizotinib) 2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 2.11 Value Chain 2.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 3. Companion Diagnostics: Qualitative and Quantitative Market Analysis 3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 3.2 Costs of Companion Diagnostics in Healthcare Expenditures 3.3 Molecular Diagnostic Market 3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 3.5 Snapshot of Companion Diagnostics Industry Structure 3.6 The Case for Theranostics 3.7 Companion Diagnostics Market Analysis Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 4. Trends and Overview 4.1 Companion Diagnostics: Industry SWOT Analysis 4.2 Macro Trends in Companion Diagnostics 4.3 Challenges for Companion Diagnostics Development 4.4 Timeline for Impact of Various Segments in Companion Diagnostics 4.5 Use of Proteomics to Develop Individualized Tests 4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 5.1 Sector Overview 5.1.1 Impact of New Technology Platforms 5.1.2 Impact on Drug Discovery 5.1.3 Biomarkers as Endpoints in Drug Discovery 5.1.4 Targeted Therapy 5.2 Companion Diagnostics on the Market 5.3 Epidermal Growth Factor Receptor Companions 5.3.1 Bevacizamab (Avastin) 5.3.2 EGFR for CRC and Camptosar (Irinotecan) 5.3.2.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 5.3.2.2 Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL 5.3.3 EGFR Express and Erbitux (Cetuximab) 5.3.4 HER2 and Heceptin (Trastuzumab) 5.3.4.1 Bayer's Advia Centaur HER2/neu Assay 5.3.4.2 Companies Marketing HER2/neu Assays 5.3.5 Iressa and Tarceva Companion Test 5.3.6 Tykerb (GlaxoSmithKline (GSK)) and Vectibix (Amgen) Companion Tests 5.3.7 EGFRx Assay 5.3.8 Monogram eTag 5.3.9 Veripath OncoDiagnostics EGFR PharmDX 5.3.10 NSCLC Patients with EGFR Mutation 5.3.11 A Personalized Medicine Program for CML 5.4 Companions Based on Myriad's IVDMIA Technology 5.4.1 Myriad's TheraGuide 5-FU 5.4.2 Myriad's BRCA Companion Diagnostics Testing for BioMarin's PARP Inhibitor BMN 673 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 5.5.1 TheraScreen: EGFR29 5.5.2 The K-RAS Mutation Detection Kit 5.6 Irinotecan and UGT1A1 5.7 Gleevec (Imatinib) Companions 5.7.1 DakoCytomation's c-Kit (9.7) pharmDx 5.8 Companion Diagnostics Involving Metabolizing Enzymes 5.8.1 Companions for TMPT, CYP2C9 and UGT1A1 Enzymes 5.8.2 Companions for Aromatase Inhibitors 5.8.3 Companions for Actos and Avandia 5.9 Drivers and Barriers to Companion Diagnostics 5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 5.12 Companion Diagnostics Used by Clinical Service Laboratories 5.13 New Technologies and Products under Development 5.13.1 OncoMethylome (now MDx Health) 5.13.2 Ventana Medical Systems Inks Companion Diagnostic Deal with Syndax for Lung Cancer Drug 5.13.3 Abbott Expands Agreement with GSK to Include Development of a Companion Diagnostic Test for the PRAME Antigen 5.14 Pharmacogenomics Tests 5.14.1 MGMT Methylation Assay 5.14.2 Other Pharmacogenomic Opportunities 5.15 Recurrence Prediction Tests 5.16 Blood-based Technologies 5.16.1 Oncotech 5.17 Monogram Biosciences HIV Personalized Platform 5.18 Wako LBA\AFP Test for Liver Cancer 5.19 Future Developments for Companion Diagnostics 5.20 Drug Response Predictors 6. Business and Regulatory Trends in the Companion Biomarker Testing Sector 6.1 Industry Consolidation 6.2 Breath of Product Offering and Pricing 6.3 Government Regulation of Medical Devices 6.3.1 FDA Guidance on Drug Test Co-development 6.3.2 Device Classes 6.3.3 Investigational Use of IVDMIAs 6.3.4 Post-market Requirements 6.3.5 Voluntary versus Required Submissions 6.3.6 Examples of Recent Voluntary Genomic Data Submissions 6.3.7 FDA Labeling Implications and Rules 6.3.8 Regulatory Activities in Companion Diagnostic Testing Translation of Diagnostic Testing Results into Clinical Practice 6.4 Strategic Business and Marketing Considerations 6.5 Commercial Opportunities in Companion Markers 6.6 Moderators of Growth 6.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 6.6.2 Management of Targeted Therapeutics by Third-Party Payers 6.7 Biotechnology Industry Trends 6.8 Pharmaceutical Industry Trends 6.9 Acquisition, License Agreement, Partnerships 6.10 Legal Developments 6.11 Sales and Marketing Strategies for Tumor Marker Tests 6.11.1 International Markets 6.11.2 Europe 6.11.3 Central and South America 6.11.4 Asia-Pacific 6.12 Product Commercialization 6.13 Reimbursement 6.14 Self-Referral Rules 6.15 Health Insurance Portability and Accountability Act 6.16 Clinical Laboratory Improvement Amendments (CLIA) 6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 6.18 FDA's Quality System Regulation (QSR) 6.19 The FDA's OIVD on IVDMIAs 6.20 FDA's Qualification of Cancer Biomarkers 6.20.1 Regulatory Perspectives of Biomarker Validation 6.21 Genetic Tests and Medical Records 6.21.1 Laws against Genetic Discrimination 6.22 Global Drivers of Clinical Laboratory Testing 6.23 Global Outlook 6.24 Oncology Biomarker Qualification Initiative 6.25 FDA Critical Path 6.25.1 Examples of Drugs being Hindered due to Lack of Compliance with FDA Directives 6.26 Biomarkers and FDA's Voluntary Genomic Data Submission 6.27 From Personalized to Predictive Medicine 6.28 Analysis of Cost-Effectiveness at the Individual Level 6.29 The Patient and Advocate Perspective: An Evolution of Influence 6.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 6.30.1 Evolving Business Models in Companion Diagnostics and Personalized Medicine 6.30.2 Current Pharma/Diagnostics Business Model Examples 6.31 Reimbursement and Value Creation 6.32 What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics? 6.33 What is the Role of the Insurance Industry in Driving the Adoption of pharmacogenomics (PGx)? 6.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 6.35 FDA Guidance Document on Co-development 6.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 6.37 What is the Future Role of PBMs in Laboratory Services? 7. Companies Entering the Companion Diagnostics Market 7.1 Industry Overview 7.1.1 20/20 GeneSystems, Inc. 7.1.2 Abbott Molecular, Inc. 7.1.3 Affymetrix, Inc. 7.1.4 Agendia BV 7.1.5 Agensys, Inc. 7.1.6 Agilent Technologies 7.1.7 Almac Group 7.1.8 AMDL, Inc. 7.1.9 Applied Biosystems 7.1.10 Asuragen, Inc. 7.1.11 Aureon Laboratories Corporation 7.1.12 Beckman Coulter, Inc. 7.1.13 Becton, Dickinson and Company (BD) Diagnostics - TriPath 7.1.14 Biocode Hycel 7.1.15 BioCurex, Inc. 7.1.16 Biodesix 7.1.17 Biomarker Technologies, LLC 7.1.18 Biomedical Diagnostics, LLC 7.1.19 Biomerica 7.1.20 bioM?rieux, Inc. 7.1.21 Biomira, Inc. 7.1.22 BioModa, Inc. 7.1.23 Bruker Daltonics 7.1.24 Byk Gulden 7.1.25 Cangen Biotechnologies, Inc. 7.1.26 Caprion Proteomics 7.1.27 Celera Diagnostics 7.1.28 Cepheid, Inc. 7.1.29 Clarient, Inc. 7.1.30 Claros Diagnostics 7.1.31 Clinical Data, Inc.: PGxHealth and Cogenics 7.1.32 Correlogic Systems, Inc. 7.1.33 CytoCore, Inc. (Formerly Known As Molecular Diagnostics, Inc.) 7.1.34 Cytogen Corporation (now EUSA Pharma) 7.1.35 Dako (Formerly DakoCytomation) 7.1.36 DiaDexus 7.1.37 DiagnoCure 7.1.38 DRG International 7.1.39 EDP Biotech Corporation 7.1.40 Eisai Co., Ltd. 7.1.41 Epigenomics 7.1.42 EXACT Sciences Corporation 7.1.43 Exagen Diagnostics 7.1.44 Gene Logic, Inc. 7.1.45 Genesis Genomics, Inc. (now known as Mitomics) 7.1.46 GenMark Diagnostics 7.1.47 Genomic Health 7.1.48 Gen-Probe, Inc. 7.1.49 Health Discovery Corporation 7.1.50 Hologic, Inc. (Formerly Cytyc Corporation) 7.1.51 Ikonisys, Inc. 7.1.52 Illumina 7.1.53 Immunomedics 7.1.54 Incyte 7.1.55 InterGenetics 7.1.56 Ipsogen 7.1.57 Johnson & Johnson 7.1.58 LabCorp 7.1.59 Life Technologies Corporation 7.1.60 Matritech, Inc. 7.1.61 Miraculins 7.1.62 Mitsubishi Kagaku latron 7.1.63 Monogram Biosciences (formerly ViroLogic Inc.) 7.1.64 Myriad Genetics, Inc. 7.1.65 NimbleGen Systems 7.1.66 Northwest Biotherapeutics, Inc. 7.1.67 Novartis MDx 7.1.68 Nycomed 7.1.69 Oncotech, Inc. 7.1.70 Oncothyreon, Inc. (Formerly known as Biomira) 7.1.71 Orion Genomics 7.1.72 Oxford BioTherapeutics (formerly Oxford Genome Sciences) 7.1.73 Panacea Pharmaceuticals, Inc. 7.1.74 Polymedco, Inc. 7.1.75 Power3 Medical Products 7.1.76 Prometheus 7.1.77 Proteome Systems Limited 7.1.78 Qiagen N.V. 7.1.79 Roche Molecular Diagnostics 7.1.80 Sanko Junyaku Co. Ltd. 7.1.81 SensiGen, LLC 7.1.82 Siemens Healthcare Diagnostics, Inc. 7.1.83 SuperArray Bioscience Corporation 7.1.84 Third Wave Technologies, Inc. (now owned by Hologic) 7.1.85 Tosoh Biosciences 7.1.86 TrimGen 7.1.87 Upstream Biosciences, Inc. 7.1.88 Ventana Medical Systems, Inc. 7.1.89 Veridex, LLC 7.1.90 Vermillion, Inc. (Formerly Ciphergen) 7.1.91 Vertex Pharmaceuticals, Inc. Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions A1.1 Introduction A1.2 Background A1.3 Submission Policy A1.3.1 General Principles A1.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling A1.3.3 Benefits of Voluntary Submissions to Sponsors and FDA A1.4 Submission of Pharmacogenomic Data A1.4.1 Submission of Pharmacogenomic Data During the IND Phase A1.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement A1.4.3 Submission to a Previously Approved NDA or BLA A1.4.4 Compliance with 21 CFR Part 58 A1.4.5 Submission of Voluntary Genomic Data from Application-Independent Research A1.5 Format and Content of a VGDS A1.6 Process for Submitting Pharmacogenomic Data A1.7 Agency Review of VGDSs Appendix 2: FDA Issues Draft Companion Diagnostic Guidance Appendix 3: Histochemical Markers for Cancer Glossary INDEX OF FIGURES Figure 2.1: Personalizing Drug Treatment 18 Figure 2.2: Approaches to Personalized Medicine 19 Figure 2.3: The Phase I and II Processes of Drug Metabolism 22 Figure 2.4: Hepatic Distribution of Human CYP450 23 Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 24 Figure 2.6: Genetic Components Determine Drug Metabolism 24 Figure 2.7: Personalized Medicine Drugs in Development 29 Figure 2.8: Healthcare Value Chain 49 Figure 3.1: From Genetic Content to Personalized Medicine 52 Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making 52 Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 53 Figure 3.4: Breakout of the Molecular Diagnostics Marketplace 54 Figure 3.5: Molecular Diagnostics Market Segmentation 55 Figure 3.6: Molecular Diagnostics Market Segmentation by Technology 55 Figure 3.7: Market Survey Respondent Demographics 60 Figure 3.8: Breakout of the Respondent Pool by Affiliation 60 Figure 3.9: Segmentation of the Personalized Medicine Market 61 Figure 4.1: Personalized Medicine Market Drivers 63 Figure 4.2: Challenges in the Personalized Medicine Space 64 Figure 5.1: Carcinogenesis is a Multi-Step Process 72 Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 79 Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 79 Figure 7.1: Epigenomics Product Development Pipeline 163 INDEX OF TABLES Table 2.1: Timeline for Development of Companion Diagnostics 19 Table 2.2: Personalized Medicine at the Nexus Point 20 Table 2.3: Percentage of Non-Responders in Various Drug Classes 21 Table 2.4: High-Profile Drug Withdrawals from the Marketplace 21 Table 2.5: Metabolism of Drugs by Hepatic Enzymes 23 Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity 25 Table 2.7: Population Frequency of the Various Cytochromes 26 Table 2.8: Selected List of Personalized Medicine Tests 28 Table 2.9: Personalized Medicine and Companion Diagnostics Product Pipeline 30 Table 2.10: Typical Response Rates in Therapeutic Areas 42 Table 2.11: Prevalence of People Taking Medications Metabolized by Liver Enzymes 43 Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan 45 Table 2.13: Current Product Labels: Enzyme Metabolism 45 Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 56 Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 56 Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 57 Table 3.4: FDA Classification of Diagnostics by Risk 59 Table 4.1: Personalized Medicine Industry SWOT Analysis 62 Table 4.2: Market Opportunities in Personalized Medicine 65 Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests 66 Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development 67 Table 4.5: Timeline of Impact in Areas of Personalized Medicine 68 Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas 69 Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics 74 Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development 74 Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 78 Table 5.4: Device Submission Elements for the FDA 87 Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 95 Table 6.2: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics 123 Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests 123 Table 7.1: Major Players in Companion Diagnostics Sector 127 Table 7.2: Opportunities for Biomarkers in Cancer Diagnosis and Treatment 152 Table 7.3: Tumor Diagnosis Immunoassay 161 Table 7.4: Tumor Diagnosis Radioimmunoassay 162 Table 7.5: Summary of Matritech's Product Development Programs 179 Companies Mentioned - 20/20 GeneSystems - Abbott Diagnostics - Affymetrix - Agendia BV - Agensys - Almac Group - AMDL - Arcturus Bioscience - Aureon Biosciences - Beckman Coulter - Biocode S.A. - BioCurex - Biomarker Technologies - Biomedical Diagnostics - Biomerica - bioM?rieux - Biomira - BioModa - Bruker Daltonics - Byk Gulden - Cangen Biotechnologies - Caprion Proteomics - Celera Diagnostics - Cepheid - Claros Diagnostics - Clinical Data: PGxHealth and Cogenics - Ciphergen Biosystems - Clarient - Correlogic Systems - Cytogen - Cytyc Corporation - Dako - DiaDexus LLC - Digene Corporation - DiagnoCure - Diagnostic Systems Laboratories - DRG International - DxS - EDP Biotech - Epigenomics - Exact Sciences Corporation - Exagen Diagnostics - Gene Logic - Genesis Genomics - Genomic Health - Gen-Probe - Health Discovery Corporation - Ikonisys - Immunicon - Immunomedics - Incyte Pharmaceuticals - InterGenetics - Ipsogen - LabCorp - Matritech - Miraculins - Mitsubishi Kagaku Medical - Molecular Diagnostics (CytoCore) - Monogram Biosciences - Myriad Genetics - NimbleGen Systems - Northwest Biotherapeutics - Oncotech - Orion Genomics - Oxford Genome Sciences - Panacea Pharmaceuticals - Perlegen Sciences - Polymedco - Power3 Medical Products - Prometheus - Proteome Systems - Qiagen - Sanko Junyaku - SensiGen - SuperArray Bioscience - Third Wave Technologies - Tosoh Medics - TrimGen - TriPath Imaging - Upstream Biosciences - Ventana Medical Systems - Veridex For more information visit http://www.researchandmarkets.com/research/35n4zz/companion About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. 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