Biomarker Technology Platforms for Cancer Diagnoses and Therapies

Biomarker Technology Platforms for Cancer Diagnoses and Therapies

The global market for glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the glucose testing segment of the in vitro diagnostics (IVD) industry is mature, certain segments of the market such as home testing devices for diabetes management will exhibit strong growth, with some—such as non-invasive testing—representing major new areas of application for IVD testing. Direct access testing, or over-the-counter, which allows consumers to order tests themselves without visiting a doctor, has emerged as a strong force in the glucose-testing segment. Moreover, an increasing range of test devices is now available to consumers for use in self-testing. The purpose of this TriMark Publications report is to describe the specific market segments for blood glucose testing and diabetes management. This study reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum or plasma or whole-blood glucose concentrations. Moreover, it examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctor's offices and at-home care locations.

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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. Introduction to Cancer Biology and the Diagnostic Industry
2.1 Biomarkers
2.1.1 The Biomarker Market Drivers
2.1.1.1 The Sector
2.1.1.2 The Critical Path Opportunities
2.1.1.3 The Capital Markets
2.2 Cancer Detection and Treatment with Biomarkers
2.2.1 The Problem
2.3 Cancer: The Disease
2.3.1 Metastasis
2.3.2 Demographics and Statistics of Cancer
2.4 Drivers of the Biotech and Diagnostics Industry
2.4.1 Venture Funding of Biotech Sector
2.4.2 Technological Innovation
2.4.3 Government Funding
2.4.4 Pharmaceutical Development and Bioanalytical Services
2.4.5 The War on Cancer
2.4.6 Current Oncology Drug Development
2.5 Outlook for Tumor Markers
2.6 Focus on Proteomics
2.6.1 Scientific Background
2.6.2 The Relationship between Proteins and Diseases
2.6.3 Limitations of Existing Diagnostic Approaches
2.6.4 Addressing the Heterogeneity of Cancer
2.6.5 Validation of Biomarkers Through Proper Study Design
2.6.6 Exploiting the Power of Mass Spectrometry to Improve Assay Specificity
2.6.7 Creating and Maintaining a Multi-Disease Product Pipeline
2.6.8 Partnerships for Developing Proteomic Biomarkers
2.7 Epigenic Markers for Cancer
2.8 Molecular Diagnostics Testing for Cancer
2.9 Market Opportunities
2.9.1 Industry Overview
2.9.2 Medical Indications and Medically Useful Information
2.9.3 Research Market
2.9.4 Competition
2.9.5 Diagnostic Services
2.9.6 Clinical Image Analysis
2.9.7 Research Imaging Market
2.9.8 Genomic Disease Management and In Vitro Diagnostic Multivariate Index Assays (IVDMIA)
2.9.9 Predictive Expression Profiles

3. Market Analysis of the Cancer Biomarkers Space
3.1 Scope of this Chapter
3.2 The Overall Market Opportunity and Segmentation of the Total Cancer Biomarkers Marketplace
3.3 Potential Cancer Biomarker Commercial Applications
3.3.1 Market for Routine Tumor Markers
3.3.2 Market for Genomic Cancer Biomarkers
3.3.3 Market Size and Forecasts for Companion Diagnostic Tests for Cancer Therapeutics
3.3.4 SWOT Analysis of the Major Cancer Biomarker Market Segments
3.3.4.1 Traditional Serum Cancer Biomarkers
3.3.4.2 Proteomic Cancer Biomarkers
3.3.4.3 Companion Diagnostic Cancer Biomarkers
3.4 Cancer Biomarker Market Estimates by Tissue of Origin
3.4.1 Colorectal
3.4.2 Prostate
3.4.3 Lung
3.4.4 Breast
3.4.5 Ovarian
3.5 Challenges Facing Cancer Biomarker Developers
3.6 Unmet Product Needs in the Cancer Biomarkers Space
3.7 Competitive Landscape of the Cancer Biomarkers Marketplace

4. Major Clinical Applications of Cancer Biomarkers
4.1 Launched Products and Pipeline
4.2 CYP2C9 Pharmacogenetics and Role in Personalized Medicine
4.3 Personalized Breast Cancer Therapy
4.4 Personalized NSCLC Therapy
4.5 AmpliChip®-based Personalized Medicine

5. Breast Cancer
5.1 Overview of Breast Cancer Disease
5.2 BRCA1 and BRCA2 Genes
5.2.1 Types of Genetic Testing Available for Breast Cancer
5.2.1.1 DNA Sequencing
5.2.1.2 Multi-Site Analysis
5.2.1.3 Single-Site Analysis
5.2.2 BRCA Test Results
5.2.2.1 What Does a Positive BRCA1 or BRCA2 Test Result Mean?
5.2.2.2 What Does a Negative BRCA1 or BRCA2 Test Result Mean?
5.2.2.3 What Does an Ambiguous BRCA1 or BRCA2 Test Result Mean?
5.2.2.4 What are the Options for a Person Who Tests Positive?
5.2.3 What are Some of the Benefits of Genetic Testing for Breast Cancer Risk?
5.2.4 What Are Some of the Risks of Genetic Testing for Breast and Ovarian Cancer Risk?
5.3 Estrogen Receptors and Breast Cancer
5.3.1 Expression and Prognostic Value of ER
5.3.2 Progesterone Receptors and Breast Cancer
5.3.3 ER and PR Predict Response to Endocrine Therapy
5.4 HER2 Gene and Protein
5.4.1 HER2 Tests
5.4.1.1 IHC Test
5.4.1.2 FISH Test
5.4.1.3 Questions About Testing
5.4.1.4 HER2 Tumor Status
5.5 Herceptin® Treatment
5.6 Tumor Assays for Adjuvant Chemotherapy
5.7 Use of Genomics to Understand Breast Cancer
5.8 Genetic Analysis Solution
5.8.1 The Use of Proteomics in Breast Cancer
5.8.2 Tissue Microarrays
5.8.3 Protein Microarrays
5.9 Gene Expression Microarrays and Recurrence Prediction
5.9.1 Oncotype DX
5.9.2 Oncotype DX for Breast Cancer
5.9.3 Risk Assessment
5.9.4 Use of Chemotherapy
5.9.5 Utility of the Oncotype Test
5.9.6 Clinical Development and Validation of Oncotype DX
5.9.6.1 Clinical Development of the Oncotype DX Recurrence Score
5.9.6.2 Clinical Validation of Prediction of Recurrence and Survival in N-, ER+ Patients Treated with Tamoxifen
5.9.6.3 Oncotype DX Predicts the Likelihood of Recurrence
5.9.6.4 Oncotype DX Predicts the Likelihood of Breast Cancer Survival in a Community Hospital Setting
5.9.6.5 Oncotype DX Predicts both Prognosis and Tamoxifen Benefit
5.10 Economic Benefits of Oncotype DX
5.11 Increased Clinical Utility of Oncotype DX
5.12 Second Generation Oncotype DX
5.12.1 Recurrence and Benefit Test for N-, ER- Breast Cancer
5.12.2 Taxane Benefit Test
5.13 MammaPrint
5.14 Rotterdam Signature 76-Panel
5.15 Summary of Microarray Technologies
5.16 Mass Spectrometry-based Approaches
5.16.1 Gel-based Approaches
5.16.2 Non-Gel-based Approaches
5.16.2.1 SELDI-TOF MS
5.16.2.2 SELDI and Prognosis
5.16.2.3 SELDI and Treatment Monitoring
5.16.3 Limitations of Mass Spectroscopy
5.17 Outlook
5.18 Future Perspectives
5.19 Breast Cancer Program (NMP66)
5.20 Myriad Genetics
5.21 Veridex GeneSearch™ Breast Lymph Node
5.22 OncoVue Cancer Risk Test
5.23 Research Biomarkers for Breast Cancer
5.24 Protein Biomarkers for Breast Cancer Prevention
5.25 Biomarker Prognosis of Breast Cancer Treated with Doxorubicin

6. Ovarian Cancer
6.1 Serum Markers
6.2 Biomarkers
6.2.1 Strategies for Discovering New Cancer Biomarkers
6.3 Serum Protein Biomarkers for Ovarian Cancer
6.3.1 Clinical Proteomics
6.4 Ovarian Cancer Triage Testing
6.4.1 Vermillion’s Ovarian Cancer Triage Diagnostic Program

7. Prostate Cancer
7.1 Overview
7.1.1 Prevalence
7.1.2 Prostate Cancer Progression and Recurrence Test
7.1.3 Current Market Size
7.2 Genes Involved in Prostate Cancer
7.3 Androgen Independence
7.4 Gene Markers in Prostate Cancer
7.5 Microarray Gene Identification of Prostate Biomarkers
7.6 GEArray DNA Microarrays
7.7 Vermillion’s Cancer Diagnostic Program
7.8 Hepsin
7.9 Matritech’s Prostate Cancer Program (NMP48)
7.10 Gen-Probe’s PCA3 Assay
7.11 Early Prostate Cancer Antigen-2 (EPCA-2)
7.12 Mass Spectrometry
7.13 Summary

8. Bladder Cancer
8.1 Overview
8.1.1 Prevalence
8.1.2 Progression and Recurrence
8.1.3 Bladder Cancer Risk Factors
8.1.4 Bladder Cancer Symptoms
8.2 Bladder Cancer Tests
8.3 UroVysion Bladder Cancer Kit
8.4 Ikoniscope® Robotic Digital Microscopy Platform
8.4.1 The CellOptics Platform
8.4.2 Cell Staining and Genetic Characterization
8.4.3 Ikoniscope/IkoniLAN Automated Microscopy
8.5 Nuclear Matrix Protein Markers
8.6 ImmunoCyt™/uCyt+™
8.7 Cangen Microsatellite DNA
8.8 Bladder Cancer Market
8.8.1 Urologist Market
8.8.2 Clinical Lab Market
8.8.3 Primary Care Market
8.8.4 Private and Public Sector Markets
8.8.5 POC Market
8.8.6 Market Distribution
8.8.7 Reimbursement

9. Colorectal Cancer
9.1 Overview
9.1.1 Prevalence
9.1.2 Progression and Recurrence
9.2 Screening for CRC
9.2.1 Stool-based DNA (sDNA) Screening
9.3 Almac Diagnostics DSA
9.4 Colon Cancer Program (NMP35)
9.5 Myriad Genetics Colaris AP Risk Assessment
9.6 Summary

10. Genetic Diagnostics Set to Revolutionize Cancer Diagnostic Testing
10.1 Overview
10.1.1 Clinicians Need for More Information with Regard to Therapeutic Treatment Drives Demand for Pharmacogenomic Testing
10.1.2 Predictive Medicine Shows Potential for Genetic Diagnostics
10.1.3 Different Rates of Growth
10.1.4 Effective Competitive Strategies
10.1.5 Improvements in Marketing Effectiveness
10.1.6 Emerging Technologies Imply Start of a New Era and Offer Tremendous Growth Opportunities
10.1.7 Increased Market Share
10.1.8 Technologies Used in Genetic Testing
10.2 AMAS Test
10.3 Corixa Antibodies as Tumor Markers
10.4 Cytovision
10.5 Ariol System
10.6 Mammaglobin Protein Expression
10.7 L523S or KOC RNA Binding Protein
10.8 CA1-18 from EDP Biotech

11. Leukemia Biomarkers
11.1 Overview
11.1.1 Prevalence
11.1.1.1 Progression and Recurrence

12. Lung Cancer

13. Enabling Technologies for Oncology Biomarker Discovery
13.1 Automated Cellular Imaging System (ACIS®)
13.1.1 ACIS for HER2 Protein Expression Testing
13.1.2 ACIS for ER Protein Expression Testing
13.1.3 ACIS for PR Protein Expression Testing
13.1.4 ACIS for Cell Proliferation Expression
13.1.5 ACIS for Protein Expression
13.1.6 ACIS for Protein Micrometastases in Bone Marrow
13.1.7 ACIS for Protein Micrometastases in Tissue
13.1.8 ACIS for Tissue Microarray
13.1.9 ACIS for DNA Ploidy
13.1.10 ACIS for HPV
13.2 DNA Methylation
13.2.1 Differential Methylation Hybridization (DMH)
13.2.2 MIRA-Assisted Microarrays for DNA Methylation Analysis and Cancer Diagnosis
13.3 Proteomics
13.3.1 Proteomics Technologies for Cancer Marker Discovery
13.3.2 Validation of Candidate Biomarkers
13.3.3 Requirements Bringing a New Marker into the Market
13.3.4 Value Chain in the Development of New Cancer Biomarkers
13.4 Secreted Proteins as Cancer Biomarkers
13.4.1 Markers of Known Tissue Origin
13.4.2 Secreted Proteins as Low Abundance Markers
13.4.3 Secreted Proteins in Tissue and Blood
13.5 Noncodings RNA as Potential Tumor Markers
13.5.1 miRNA Meets Microarray
13.5.2 Mimetics and Inhibitors
13.5.3 Clinical Patterns in Cancer
13.6 Architect TIMP-1 (Tissue Inhibitor of Metalloproteinases-1) Immunoassay for Colorectal Cancer Detection
13.7 Companies Developing Automated Microscope-based Analysis Systems
13.8 Companies Developing Research Products for Tumor Cell Isolation
13.9 Companies Supplying Fluorescently Labeled Antibodies to Characterize Tumor Cells
13.10 PerkinElmer High Throughput Platforms: AlphaScreen®, AequoScreen®, DELFIA® and LANCE® Technologies

14. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics
14.1 Sector Overview
14.2 Companion Diagnostics
14.3 EGFR for Colorectal Cancer and Camptostar (Irinotecan)
14.4 EGFR Express and Erbitux (Cetuximab)
14.5 HER2 and Heceptin
14.6 Myriad’s TheraGuide 5-FU
14.7 TheraScreen: EGFR29
14.8 Drivers and Barriers to Companion Diagnostics
14.9 Partnerships with Pharma Companies to Identify Therapeutic Targets
14.10 Future Developments for Companion Diagnostics

15. Companion Diagnostics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends
15.1 Scope of this Chapter
15.2 Introduction to Companion Diagnostics and Personalized Medicine
15.3 The Compelling Case for Personalized Medicine
15.4 Drug Metabolism and Implications for Companion Diagnostics and Personalized Medicine
15.5 Examples of Personalized Medicine
15.6 Personalized Medicine and Companion Diagnostics Testing Product Pipeline
15.7 The Personalized Medicine Coalition
15.8 Regulatory Trends and Guidelines in the Personalized Medicine Space
15.8.1 The Changing Regulatory Landscape for Personalized Medicine
15.9 Patenting Personalized Medicine
15.10 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine and Companion Diagnostics is Appropriate and Being Deployed
15.10.1 EGFR Assay
15.10.2 Individualized Warfarin Therapy
15.10.3 UGT1A1 Molecular Assay for Camptosar
15.10.4 Response to Gleevec in Gastrointestinal Stromal Tumors
15.10.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases
15.10.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Companion Diagnostics
15.11 Companion Diagnostics and Personalized Medicine: Qualitative and Quantitative Market Analysis
15.11.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics and Personalized Medicine
15.11.2 Diagnostics vs. Pharmaceuticals
15.11.3 Molecular Diagnostic Market
15.11.4 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine
15.12 Snapshot of Companion Diagnostics Industry Structure
15.13 The Case for Theranostics (Therapeutic/Companion Diagnostic)
15.14 Personalized Medicine Market Analysis—Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters
15.15 How the Market Segregates Today
15.16 Timeline for Impact of Various Segments in Personalized Medicine
15.17 Challenges for Personalized Therapeutics and Companion Diagnostics Development
15.18 Macro Trends in Personalized Medicine
15.19 Personalized Medicine and Companion Diagnostics: Industry SWOT Analysis

16. Cancer Biomarker Testing Sector and Company Analysis
16.1 Abbott Molecular, Inc. (Formerly Vysis, Inc.)
16.2 Agendia
16.3 AMDL, Inc.
16.4 Aureon Laboratories, Inc.
16.5 BioCurex
16.6 Biomarker Technologies
16.7 Biomedical Diagnostics LLC
16.8 Biomerica
16.9 Biomira, Inc.
16.10 Biomoda
16.11 Byk Gulden
16.12 Clarient
16.13 Correlogic Systems, Inc.
16.14 Cytogen Corporation
16.15 Dako (Formerly Dako Cytomation)
16.16 diaDexus
16.17 Diagnocure, Inc. (ImmunoCyt™/uCyt+™)
16.18 DxS Ltd.
16.19 Epigenomics
16.20 Exagen Diagnostics, Inc.
16.21 Genesis Genomics
16.22 Health Discovery Corporation
16.23 Immunicon
16.24 Ipsogen
16.25 InterGenetics
16.26 Miraculins, Inc.
16.27 Molecular Devices Inc. (Formerly Arcturus Bioscience, Inc.)
16.28 Myriad Genetics, Inc.
16.29 Orion Genomics
16.30 Power3 Medical Products
16.31 Qiagen N.V.
16.32 SuperArray Bioscience Corporation
16.33 Upstream Biosciences, Inc.
16.34 Ventana Medical Systems, Inc.
16.35 Veridex
16.36 Vermillion

17. Business Trends in the Industry
17.1 Industry Consolidation
17.2 Breadth of Product Offering and Pricing
17.3 Government Regulation of Medical Devices
17.3.1 FDA Guidance on Drug Test Co-development
17.4 Strategic Business and Marketing Considerations
17.5 Commercial Opportunities in Cancer Markers
17.5.1 Licensing and Intellectual Property (IP) Constraints and how they will Impact New Product Development
17.6 Moderators of Growth
17.6.1 Roadblocks to Integrating Cancer Biomarkers into Clinical Practice
17.7 Biotechnology Industry Trends
17.8 Pharmaceutical Industry Trends
17.9 Acquisition, License Agreement, Partnerships
17.10 Legal Developments
17.11 Sales and Marketing Strategies for Tumor Marker Tests
17.11.1 North American Market
17.11.2 International Markets
17.11.2.1 Europe
17.11.2.2 Central and South America
17.11.2.3 Asia/Pacific
17.12 Product Commercialization
17.13 Reimbursement
17.14 Self Referral Rules
17.15 Health Insurance Portability and Accountability Act
17.16 Clinical Laboratory Improvement Amendments (CLIA)
17.17 In-Vitro Diagnostic Directive (IVDD) and Medical Device Regulations
17.18 FDA’s Quality System Regulation (QSR)
17.19 FDA’s OIVD on IVDMIAs
17.20 FDA’s Qualification of Cancer Biomarkers
17.20.1 Regulatory Perspectives of Biomarker Validation
17.21 Genetic Tests and Medical Records
17.21.1 Laws against Genetic Discrimination
17.22 Medicare Reimbursement
17.22.1 Medicare Part B Spending Trends
17.23 Global Drivers of Clinical Laboratory Testing
17.24 Global Outlook for Cancer Biomarkers
17.24.1 Which Companies are Utilizing Cutting-Edge Technologies to Develop, Validate and Implement Cancer Biomarkers for Clinical Use?
17.24.2 What Impediments Still Exist to Incorporating Promising Research into Clinical Practice?
17.24.3 Which Biomarkers Show the Most Promise for Approval?
17.24.4 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
17.24.5 Which Alliances Show the Greatest Synergy in Bringing Valid Biomarkers to Market?
17.24.6 Which Shared Technologies are Driving the Most Encouraging Development?
17.24.7 How Strategic Alliances and Interdisciplinary Involvement Drive Development and Implementation of Emerging Biomarker Technologies
17.25 Oncology Biomarker Qualification Initiative
17.26 FDA Critical Path
17.27 FDA Criteria for a Valid Biomarker

18. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms
18.1 Abbott Diagnostics
18.2 Affymetrix, Inc.
18.3 Agendia BV
18.4 Agensys, Inc.
18.5 Almac Group
18.6 AMDL, Inc.
18.7 Aureon Laboratories, Inc.
18.8 Bayer Diagnostics Corporation
18.9 Beckman Coulter, Inc.
18.10 Biocode S.A.
18.11 BioCurex, Inc.
18.12 Biomarker Technologies LLC
18.13 Biomedical Diagnostics LLC
18.14 Biomerica
18.15 bioMérieux
18.16 Biomira, Inc.
18.17 Biomoda, Inc.
18.18 Bruker Daltonics, Inc.
18.19 Byk Gulden
18.20 Cangen Biotechnologies, Inc.
18.21 Caprion Proteomics
18.22 Celera Diagnostics
18.23 Cepheid
18.24 Clarient, Inc.
18.25 Claros Diagnostics, Inc.
18.26 Clinical Data, Inc.: PGxHealth and Cogenics
18.27 Correlogic Systems, Inc.
18.28 CytoCore (Formerly Molecular Diagnostics, Inc.)
18.29 Cytogen Corporation
18.30 Dako (Formerly Dako Cytomation)
18.31 diaDexus LLC
18.32 DiagnoCure, Inc.
18.33 Diagnostic Products Corporation
18.34 Diagnostic Systems Laboratories, Inc.
18.35 Digene Corporation
18.36 DRG International, Inc.
18.37 DxS Ltd.
18.38 EDP Biotech Corporation
18.39 Eisai Co., Ltd.
18.40 Epigenomics
18.41 Exact Sciences Corporation
18.42 Exagen Diagnostics, Inc.
18.43 Gene Logic, Inc.
18.44 Genesis Genomics, Inc.
18.45 Genomic Health, Inc.
18.46 Gen-Probe, Inc.
18.47 Health Discovery Corporation
18.48 Hologic, Inc. (Formerly Cytyc Corporation)
18.49 Ikonisys, Inc.
18.50 Immunicon Corporation
18.51 Immunomedics, Inc.
18.52 Incyte Pharmaceuticals, Inc.
18.53 InterGenetics®
18.54 Ipsogen
18.55 LabCorp®
18.56 Matritech, Inc.
18.57 Miraculins, Inc.
18.58 Mitsubishi Kagaku Medical
18.59 Molecular Devices (Formerly Arcturus Biosciences, Inc.)
18.60 Myriad Genetics, Inc.
18.61 NimbleGen Systems, Inc.
18.62 Northwest Biotherapeutics, Inc.
18.63 Oncotech, Inc.
18.64 Orion Genomics
18.65 Oxford Genome Sciences
18.66 Panacea Pharmaceuticals, Inc.
18.67 Phenomenone Discoveries
18.68 Polymedco, Inc.
18.69 Power3 Medical Products
18.70 Proteome Systems Ltd.
18.71 Qiagen N.V.
18.72 Sanko Junyaku Co., Ltd.
18.73 SensiGen LLC
18.74 SuperArray Bioscience Corporation
18.75 Third Wave Technologies, Inc.
18.76 Tosoh Medics, Inc.
18.77 TriPath Imaging, Inc.
18.78 Upstream Biosciences, Inc.
18.79 Ventana Medical Systems, Inc.
18.80 Veridex LLC
18.81 Vermillion, Inc. (Formerly Ciphergen)

Appendix 1: Cancer Biomarker Centers of Research
Appendix 2: Myriad Patents on Genes BRAC1 and BRAC2
Appendix 3: Common Laboratory Tests for Cancer
Appendix 4: Questions/Issues in the Cancer Biomarkers Space
Appendix 5: Cancer Markers Currently in Common Clinical Use
Appendix 6: International Federation of Gynecology and Obstetrics (FIGO) Staging System for Primary Carcinoma of the Ovary
Appendix 7: FDA Guidance for Industry: Pharmacogenomic Data Submission
A7.1 Introduction
A7.2 Background
A7.3 Submission Policy
A7.3.1 General Principles
A7.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling
A7.3.3 Benefits of Voluntary Submissions to Sponsors and FDA
A7.4 Submission of Pharmacogenomic Data
A7.4.1 Submission of Pharmacogenomic Data During the IND Phase
A7.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement
A7.4.3 Submission to a Previously Approved NDA or BLA
A7.4.4 Compliance with 21 CFR Part 58
A7.4.5 Submission of Voluntary Genomic Data from Application-Independent Research
A7.5 Format and Content of a VGDS
A7.6 Process for Submitting Pharmacogenomic Data
A7.7 Agency Review of VGDSs

Glossary


INDEX OF FIGURES

Figure 3.1: Potential Market for Cancer Biomarkers, 2006
Figure 3.2: Segmentation of the Cancer biomarkers Marketplace Based Upon Commercial Offerings—Products and Services
Figure 3.3: Geographical Distribution of Cancer Tumor Diagnostic Testing
Figure 3.4: Cancer Biomarkers Research Market, 2006-2011
Figure 3.5: Breast Cancer Biomarker Market Potential, 2005
Figure 3.6: Challenges in the Study or Utilization of Proteomic Cancer Biomarkers
Figure 3.7: Challenges in the Study or Utilization of Companion Diagnostic Cancer Biomarkers
Figure 3.8: Challenges in the Study or Utilization of Serum Cancer Markers
Figure 3.9: Top Unmet Needs in Commercial Products in the Cancer Biomarkers Space
Figure 5.1: Hybridization Process
Figure 5.2: FISH Test Procedure
Figure 5.3: Gene Expression Profiling
Figure 15.1: Phase I and II Processes of Drug Metabolism
Figure 15.2: Human Phase I Enzymes
Figure 15.3: Human Phase II Enzymes
Figure 15.4: Hepatic Distribution of Human CYP450
Figure 15.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism
Figure 15.6: Genetic Components Determine Drug Metabolism
Figure 15.7: From Genetic Content to Personalized Medicine
Figure 15.8: Remuneration for Diagnostics
Figure 15.9: Breakout of the Molecular Diagnostics Marketplace
Figure 15.10: Molecular Diagnostics Market Segmentation
Figure 15.11: Molecular Diagnostics Market Segmentation by Technology
Figure 15.12: Market Survey Respondent Demographics
Figure 15.13: Breakout of the Respondent Pool by Affiliation
Figure 15.14: Segmentation of the Personalized Medicine Market
Figure 15.15: Personalized Medicine Market Drivers
Figure 15.16: Challenges in the Personalized Medicine Space
Figure 16.1: Epigenomics Product Development Pipeline
Figure 17.1: Medicare Part B Spending on Clinical Laboratory Services, 1991-2005


INDEX OF TABLES

Table 2.1: Cancer Biomarkers at the Nexus Point
Table 2.2: Drug Development by Type of Cancer
Table 2.3: Organ Specific Medicines in Development for Cancer, 2006
Table 2.4: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex, 2007
Table 2.5: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer
Table 2.6: Estimated Number of New Cancer Cases and Deaths by Region
Table 2.7: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country
Table 2.8: Cancer Associated Genes
Table 2.9: Carcinogens in the Workplace
Table 2.10: Cancer Biomarker Markets
Table 2.11: Private Funding Levels for the Biotechnology Segment, 1995-2006
Table 2.12: Global Pharmaceutical Industry R&D Spending, 1995-2006
Table 2.13: U.S. Government NIH Research Budget, 1995-2007
Table 2.14: Tumor Markers Currently in Common Use
Table 2.15: Herceptin Worldwide Sales, 1999-2007
Table 2.16: Classes of Drugs Used to Treat Breast Cancer
Table 2.17: Solutions to Biomarker Developments
Table 2.18: Vermillion Collaborations
Table 2.19: Uses of Molecular Diagnostics in Detection and Management of Cancer
Table 2.20: U.S. Cancer Diagnostic Testing Market Size, 2005-2012
Table 2.21: Market Opportunities for Cancer Biomarker Technology Platforms
Table 3.1: Characteristics of Different Cancer Biomarker Types and Associated Market Opportunities
Table 3.2: Segmentation of the Cancer Biomarker Market by Type/Lineage of Cancer Biomarkers and Market Size
Table 3.3: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 2007
Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 2005
Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market
Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets
Table 3.13: Worldwide CEA Sales, 2001-2010
Table 3.14: U.S. CEA Sales, 2001-2010
Table 3.15: Cancer Genomic Biomarker Markets, 2002-2012
Table 3.16: Cancer Biomarkers Research Market Forecast, 2006-2011
Table 3.17: Cancer Biomarker Market Estimates by Tissue of Origin
Table 3.18: Companies Developing New Proteomic Cancer Biomarker Technology Platforms
Table 4.1: Cancer Biomarkers Used to Maximize Likelihood of Response
Table 4.2: Biomarkers for Monitoring Therapeutic Effectiveness and Resistance
Table 4.3: Biomarkers for Dose Response of Therapy
Table 4.4: Decision on Optimal Duration of Therapy
Table 5.1: U.S. Breast Cancer Rate Decline, 2002-2006
Table 5.2: BRCA Development Model
Table 5.3: BRCA Test Development and Commercialization
Table 5.4: BRAC Analysis
Table 5.5: Revenue for BRACAnalysis® Risk Assessment Test, 2002-2006
Table 5.6: GEArray DNA Microarrays and RT2 Profiler PCR Arrays
Table 5.7: Product Development Opportunities in Breast Cancer
Table 5.8: Concentration of Some Abundant Proteins, New Cancer Biomarkers Identified by SELDI-TOF, and Classical Cancer Biomarkers in Serum
Table 5.9: Questions Related to Diagnostic SELDI-TOF Technology
Table 6.1: Worldwide CA-125 Sales, 2001-2010
Table 6.2: U.S. CA-125 Sales, 2001-2010
Table 6.3: Some Clinically Established Cancer Serum Markers Currently in Use for Cancer
Table 6.4: Pathophysiology of Ovarian Cancer and Characterization of Ovarian Epithelial Tumors
Table 7.1: Worldwide PSA Sales, 2000-2010
Table 7.2: U.S. PSA Sales, 2000-2010
Table 7.3: Molecular Gene Markers for Prostate Cancer
Table 8.1: Worldwide Bladder Cancer Marker Sales, 2001-2010
Table 8.2: U.S. Bladder Cancer Marker Sales, 2001-2010
Table 8.3: Worldwide NMP22 Sales, 2001-2010
Table 8.4: Summary of Matritech’s Product Development Programs
Table 8.5: Opportunities for Bladder Cancer Biomarkers
Table 9.1: TNM Staging for Colorectal Cancer
Table 10.1: Genetic Diagnostics Market, 2004-2012
Table 13.1: Genomic and Proteomic Technologies
Table 14.1: Potential Benefits of Biomarkers as Companion Diagnostics
Table 14.2: Utility of Biomarker as Companion Diagnostics to Drug Development
Table 14.3: Device Submission Elements for the FDA
Table 14.4: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics
Table 14.5: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests
Table 15.1: Percentage of Non-Responders in Various Drug Classes
Table 15.2: High Profile Drug Withdrawals from the Marketplace
Table 15.3: Drug Metabolism Drives Drug Efficacy/Toxicity
Table 15.4: Population Frequency of the Various Cytochromes
Table 15.5: Selected List of Personalized Medicine Tests
Table 15.6: Personalized Medicine and Companion Diagnostics Product Pipeline
Table 15.7: Marketed Personalized Therapies, 2006
Table 15.8: Various Molecular Diagnostics Technologies: Timeline for Impact
Table 15.9: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine
Table 15.10: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine
Table 15.11: Classification of Diagnostics by Risk
Table 15.12: Areas in Personalized Medicine—Timeline of Impact
Table 15.13: Impact of Personalized Medicine on Various Therapeutic Areas
Table 15.14: Hurdles in Personalized Medicine and Companion Diagnostics Development in Various Therapeutic Areas
Table 15.15: Market Opportunities in Personalized Medicine
Table 15.16: Challenges for Market Adoption of the Various Personalized Medicine Tests
Table 15.17: Personalized Medicine Industry SWOT
Table 16.2: Clarient Revenue, 2002-2006
Table 16.3: Clarient Percentage of Revenue, 2004-2006
Table 16.4: Opportunities for Biomarkers in Cancer Diagnosis and Treatment
Table 16.5: Myriad Biomarker Revenue, 2002-2006
Table 17.1: List and Discounted Prices for Abbott Tumor Marker Tests
Table 17.2: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005
Table 17.3: Medicare Spending on Clinical Lab Services, 1991-2005
Table 17.4: Medicare Part B Spending Per Medicare Enrollee, 1998-2005
Table 18.1: Tumor Diagnosis Immunoassay
Table 18.2: Tumor Diagnosis Radioimmunoassay
Table 18.3: Summary of Matritech’s Product Development Programs
Table A1: Team Descriptions
Table A5: Cancer Markers in Use