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Companion Diagnostics in Personalized Medicine and Cancer Therapy

TriMark Publications
February 1, 2012
214 Pages - SKU: TRI6822265

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Companion Diagnostics in Personalized Medicine and Cancer Therapy

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.

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; 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care; 2.9 Specific Examples of Clinical Situations where Companion Diagnostics are; being Deployed; 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; 5.2 Companion Diagnostics on the Market; 5.3 Epidermal Growth Factor Receptor Companions; 5.4 Companions Based on Myriad’s IVDMIA Technology; 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib; 5.6 Irinotecan and UGT1A1; 5.7 Gleevec (Imatinib) Companions; 5.8 Companion Diagnostics Involving Metabolizing Enzymes; 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; 5.14 Pharmacogenomics Tests; 5.15 Recurrence Prediction Tests; 5.16 Blood-based Technologies; 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; 6.4 Strategic Business and Marketing Considerations; 6.5 Commercial Opportunities in Companion Markers; 6.6 Moderators of Growth; 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; 6.12 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; 6.21 Genetic Tests and Medical Records; 6.22 Global Drivers of Clinical Laboratory Testing; 6.23 Global Outlook; 6.24 Oncology Biomarker Qualification Initiative; 6.25 FDA Critical Path; 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; 6.31 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
Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions: A1.1 Introduction; A1.2 Background; A1.3 Submission Policy; A1.4 Submission of Pharmacogenomic Data; 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; Figure 2.2: Approaches to Personalized Medicine; Figure 2.3: The Phase I and II Processes of Drug Metabolism; Figure 2.4: Hepatic Distribution of Human CYP450; Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism; Figure 2.6: Genetic Components Determine Drug Metabolism; Figure 2.7: Personalized Medicine Drugs in Development; Figure 2.8: Healthcare Value Chain; Figure 3.1: From Genetic Content to Personalized Medicine; Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making; Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending; Figure 3.4: Breakout of the Molecular Diagnostics Marketplace; Figure 3.5: Molecular Diagnostics Market Segmentation; Figure 3.6: Molecular Diagnostics Market Segmentation by Technology; Figure 3.7: Market Survey Respondent Demographics; Figure 3.8: Breakout of the Respondent Pool by Affiliation; Figure 3.9: Segmentation of the Personalized Medicine Market; Figure 4.1: Personalized Medicine Market Drivers; Figure 4.2: Challenges in the Personalized Medicine Space; Figure 5.1: Carcinogenesis is a Multi-Step Process; Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal; Results with IHC; Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by; FISH; Figure 7.1: Epigenomics Product Development Pipeline
INDEX OF TABLES: Table 2.1: Timeline for Development of Companion Diagnostics; Table 2.2: Personalized Medicine at the Nexus Point; Table 2.3: Percentage of Non-Responders in Various Drug Classes; Table 2.4: High-Profile Drug Withdrawals from the Marketplace; Table 2.5: Metabolism of Drugs by Hepatic Enzymes; Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity; Table 2.7: Population Frequency of the Various Cytochromes; Table 2.8: Selected List of Personalized Medicine Tests; Table 2.9: Personalized Medicine and Companion Diagnostics Product Pipeline; Table 2.10: Typical Response Rates in Therapeutic Areas; Table 2.11: Prevalence of People Taking Medications Metabolized by Liver Enzymes; Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan; Table 2.13: Current Product Labels: Enzyme Metabolism; Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on; Personalized Medicine; Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in; Personalized Medicine; Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in; Personalized Medicine; Table 3.4: FDA Classification of Diagnostics by Risk; Table 4.1: Personalized Medicine Industry SWOT Analysis; Table 4.2: Market Opportunities in Personalized Medicine; Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests; Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics; Development; Table 4.5: Timeline of Impact in Areas of Personalized Medicine; Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas; Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics; Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development; Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to; Interpret Test Results; Table 5.4: Device Submission Elements for the FDA; Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests; Table 6.2: Summary of Biomarker Use in the Commercialization of Novel Oncology; Pharmacotherapeutics; Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers as; Companion Diagnostic Tests; Table 7.1: Major Players in Companion Diagnostics Sector; Table 7.2: Opportunities for Biomarkers in Cancer Diagnosis and Treatment; Table 7.3: Tumor Diagnosis Immunoassay; Table 7.4: Tumor Diagnosis Radioimmunoassay; Table 7.5: Summary of Matritech’s Product Development Programs

Companion Diagnostics in Personalized Medicine and Cancer Therapy

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