May 12, 2008 22:13 ET

Examine the Biomarker Technology Platforms for Cancer Diagnoses and Therapies

LONDON, UNITED KINGDOM--(Marketwire - May 12, 2008) - announces that a new market research report related to the Medical devices industry is available in its catalogue.

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 The Sector The Critical Path Opportunities 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
3.3.4 SWOT Analysis of the Major Cancer Biomarker Market Segments Traditional Serum Cancer Biomarkers Proteomic Cancer Biomarkers 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(R)-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 DNA Sequencing Multi-Site Analysis Single-Site Analysis 
5.2.2 BRCA Test Results What Does a Positive BRCA1 or BRCA2 Test Result Mean? What Does a Negative BRCA1 or BRCA2 Test Result Mean? What Does an Ambiguous BRCA1 or BRCA2 Test Result Mean? 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
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 IHC Test FISH Test Questions About Testing HER2 Tumor Status 
5.5 Herceptin(R) 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 Clinical Development of the Oncotype DX Recurrence Score Clinical Validation of Prediction of Recurrence and Survival in N-,
 ER+ Patients Treated with Tamoxifen Oncotype DX Predicts the Likelihood of Recurrence Oncotype DX Predicts the Likelihood of Breast Cancer Survival in a
 Community Hospital Setting 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 SELDI-TOF MS SELDI and Prognosis 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(TM) 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(R) 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(TM)/uCyt+(TM) 
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 Progression and Recurrence 

12. Lung Cancer 

13. Enabling Technologies for Oncology Biomarker Discovery 
13.1 Automated Cellular Imaging System (ACIS(R)) 
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
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(R), AequoScreen(R),
 DELFIA(R) and LANCE(R) Technologies 

14. Biomarker Tests Co-developed with Cancer Therapeutics as Companion
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
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
15.18 Macro Trends in Personalized Medicine 
15.19 Personalized Medicine and Companion Diagnostics: Industry SWOT

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(TM)/uCyt+(TM)) 
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 Europe Central and South America 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
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
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
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 bioMerieux 
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(R) 
18.54 Ipsogen 
18.55 LabCorp(R) 
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
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
A7.5 Format and Content of a VGDS 
A7.6 Process for Submitting Pharmacogenomic Data 
A7.7 Agency Review of VGDSs 



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
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
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,


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
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,
Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size,
Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size,
Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size,
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
Table 4.1: Cancer Biomarkers Used to Maximize Likelihood of Response 
Table 4.2: Biomarkers for Monitoring Therapeutic Effectiveness and
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(R) 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
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 

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