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Biomarker Technology Platforms for Cancer Diagnoses and Therapies

  • July 2014
  • -
  • TriMark Publications
  • -
  • 399 pages

Until superior therapeutic treatments are developed to prevent, treat and cure cancer, the best means of reducing mortality and morbidity in a disease this complex is early detection and diagnosis. In the major solid cancer types such as lung, breast, colon and prostate, long-term survival rates drop precipitously once metastatis has occurred. The case is clear for development of biomarkers for early detection and screening tests for diseases such as breast, colon, ovarian and lung cancer. In addition, diagnostic measurement of cancer disease progression is essential to successful disease management. For these reasons, development of new and effective biomarkers for cancer detection and diagnosis is central to the cancer problem. The use of nucleic acid biomarker diagnostics have begun to answer these questions. Protein biomarkers are also useful. The purpose of this TriMark Publications report is to describe the specific segment of the cancer diagnostics market which develops new biomarker technology platforms for diagnosing and treating cancer. Biomarkers are useful in following the course of cancer and evaluating which therapeutic regimes are most effective for a particular type of cancer, as well as determining long-term susceptibility to cancer or recurrence. This study particularly examines those clinical measurement devices, and their reagents and supplies, which are meant to be used in hospitals, clinics, commercial laboratories and doctor’s offices to diagnose and monitor cancer. The examination also provides an in-depth discussion of the application of biomarkers in developing novel targeted cancer therapeutics, their predication response and efficacy, as well as their use in diagnosis of cancer.

Table Of Contents

Biomarker Technology Platforms for Cancer Diagnoses and Therapies
1. Overview 13
1.1 Statement of Report 13
1.2 About This Report 13
1.3 Scope of the Report 13
1.4 Objectives 14
1.5 Methodology 14
1.6 Executive Summary 15

2. Introduction to Cancer Biology and the Diagnostic Industry 20
2.1 Biomarkers 20
2.1.1 The Biomarker Market for Cancer and Key Sectors 20
2.1.1.1 The Sector 20
2.1.1.2 The Critical Path Opportunities 20
2.1.1.3 Capital Markets 20
2.1.1.4 Molecular Diagnostics Technology Platforms 21
2.2 Cancer Detection and Treatment Using Biomarkers as a Guide 21
2.2.1 The Problem 23
2.3 Next Generation Sequencing and Biomarker Discovery 25
2.3.1 Second-Generation Sequencing 26
2.3.2 Whole Genome Sequencing (WGS) 26
2.3.3 Epigenomics 26
2.3.4 Bioinformatics and Next Generation Sequencing 27
2.3.5 Third Next Generation Sequencing 27

3. Market Analysis of the Cancer Biomarkers Space 28
3.1 Scope of This Chapter 28
3.2 The Overall Market Opportunity and Segmentation of the Total Cancer Biomarkers Marketplace 28
3.3 Potential Cancer Biomarker Commercial Applications 32
3.3.1 Market for Routine Tumor Markers 32
3.3.2 PSA Testing Market Size 39
3.3.3 Market Size and Forecasts for Companion Diagnostic Tests for Cancer Therapeutics 41
3.3.4 SWOT Analysis of the Major Cancer Biomarker Market Segments 44
3.3.4.1 Traditional Serum Cancer Biomarkers 44
3.3.4.2 Proteomic Cancer Biomarkers 44
3.3.4.3 Companion Diagnostic Cancer Biomarkers 45
3.4 Cancer Biomarker Market Estimates by Tissue of Origin 46
3.4.1 Colorectal 47
3.4.2 Prostate 47
3.4.3 Lung 48
3.4.4 Breast 48
3.4.5 Ovarian 49
3.5 Challenges Facing Cancer Biomarker Developers 49
3.6 Unmet Product Needs in the Cancer Biomarkers Space 51
3.7 Epigenic Markers for Cancer 56
3.8 Molecular Diagnostics Testing for Cancer 56
3.9 Market Opportunities 57
3.9.1 Industry Overview 57
3.9.2 Medical Indications and Medically Useful Information 59
3.9.3 Research Market 61
3.9.4 Competition 61
3.9.5 Diagnostic Services 61
3.9.6 Clinical Image Analysis 61
3.9.7 Research Imaging Market 61
3.9.8 Genomic Disease Management and In Vitro Diagnostic Multivariate Index Assays (IVDMIA) 62
3.9.9 Predictive Expression Profiles 63

4. Major Clinical Applications of Cancer Biomarkers 64
4.1 Launched Products and Pipeline 64
4.2 Launched Products and Pipeline 66
4.3 CYP2C9 Pharmacogenetics and Role in Personalized Medicine 71
4.4 Personalized Breast Cancer Therapy 72
4.5 Personalized NSCLC Therapy 72
4.6 AmpliChip-Based Personalized Medicine 72

5. Breast Cancer 74
5.1 Overview of Breast Cancer Disease 74
5.2 Incidence and Mortality Rates 74
5.2.1 Incidence Rates 74
5.2.2 Mortality Rates 75
5.3 BRCA1 and BRCA2 Genes 76
5.3.1 Types of Genetic Testing Available for Breast Cancer 79
5.3.1.1 DNA Sequencing 79
5.3.1.2 Multi-Site Analysis 79
5.3.1.3 Single-Site Analysis 79
5.3.2 BRCA Test Results 79
5.3.2.1 What Does a Positive BRCA1 or BRCA2 Test Result Mean? 79
5.3.2.2 What does a Negative BRCA1 or BRCA2 Test Result Mean? 80
5.3.2.3 What does an Ambiguous BRCA1 or BRCA2 Test Result Mean? 80
5.3.2.4 What are the Options for a Person who Tests Positive? 80
5.3.3 What are Some of the Benefits of Genetic Testing for Breast Cancer Risk? 81
5.3.4 What are Some of the Risks of Genetic Testing for Breast and Ovarian Cancer Risk? 81
5.4 Estrogen Receptors and Breast Cancer 81
5.4.1 Expression and Prognostic Value of ER 82
5.4.2 Progesterone Receptors and Breast Cancer 82
5.4.3 ER and PR Predict Response to Endocrine Therapy 83
5.5 HER2 Gene and Protein 83
5.5.1 HER2 Tests 83
5.5.1.1 IHC Test 84
5.5.1.2 FISH Test 84
5.5.1.3 Questions About Testing 86
5.5.1.4 HER2 Tumor Status 87
5.6 Herceptin Treatment 87
5.7 Tumor Assays for Adjuvant Chemotherapy 89
5.8 Use of Genomics to Understand Breast Cancer 90
5.9 Genetic Analysis Solution 91
5.9.1 The Use of Proteomics in Breast Cancer 93
5.9.2 Tissue Microarrays 95
5.9.3 Protein Microarrays 97
5.10 Gene Expression Microarrays and Recurrence Prediction 98
5.10.1 Oncotype DX 98
5.10.2 Oncotype DX for Breast Cancer 99
5.10.3 Risk Assessment 99
5.10.4 Use of Chemotherapy 100
5.10.5 Utility of the Oncotype DX Test 100
5.10.6 Clinical Development and Validation of Oncotype DX 100
5.10.6.1 Clinical Development of the Oncotype DX Recurrence Score 100
5.10.6.2 Clinical Validation of Prediction of Recurrence and Survival in N?, ER+ Patients Treated with
Tamoxifen 101
5.10.6.3 Oncotype DX Predicts the Likelihood of Recurrence 101
5.10.6.4 Oncotype DX Predicts the Likelihood of Breast Cancer Survival in a Community Hospital Setting 102
5.10.6.5 Oncotype DX Predicts both Prognosis and Tamoxifen Benefit 102
5.11 Economic Benefits of Oncotype DX 103
5.12 Increased Clinical Utility of Oncotype DX 104
5.13 Second Generation Oncotype DX 104
5.13.1 Recurrence and Benefit Test for N?, ER? Breast Cancer 104
5.13.2 Taxane Benefit Test 104
5.14 MammaPrint 104
5.15 Rotterdam Signature 76-Panel 105
5.16 Summary of Microarray Technologies 106
5.17 Mass Spectrometry-Based Approaches 106
5.17.1 Gel-Based Approaches 106
5.17.2 Non-Gel-Based Approaches 107
5.17.2.1 SELDI-TOF MS 108
5.17.2.2 SELDI and Prognosis 109
5.17.2.3 SELDI and Treatment Monitoring 109
5.18 Outlook 111
5.19 Future Perspectives 113
5.20 Breast Cancer Program (NMP66) 114
5.21 Myriad Genetics 114
5.22 Janssen Diagnostics, LLC GeneSearch Breast Lymph Node 115
5.23 OncoVue® Cancer Risk Test (InterGenetics, Inc.) 115
5.24 Research Biomarkers for Breast Cancer 116
5.25 Protein Biomarkers for Breast Cancer Prevention 117
5.26 Biomarker Prognosis of Breast Cancer Treated with Doxorubicin 117

6. Ovarian Cancer 118
6.1 Incidence Rates 118
6.1.1 Incidence Rates 118
6.1.2 Mortality Rates 119
6.2 Serum Markers 121
6.3 Biomarkers 122
6.3.1 Strategies for Discovering New Cancer Biomarkers 123
6.4 Serum Protein Biomarkers for Ovarian Cancer 123
6.4.1 Clinical Proteomics 124
6.5 Ovarian Cancer Triage Testing 125
6.5.1 Vermillion's Ovarian Cancer Triage Diagnostic Program 126

7. Prostate Cancer 128
7.1 Overview 128
7.1.1 Incidence Rates 128
7.1.2 Mortality Rates 128
7.1.3 Prostate Cancer Progression and Recurrence Test 128
7.1.4 Current Market Size 129
7.2 Genes Involved in Prostate Cancer 130
7.3 Androgen Independence 131
7.4 Gene Markers in Prostate Cancer 131
7.5 Microarray Gene Identification of Prostate Biomarkers 132
7.6 GEArray DNA Microarrays 134
7.7 Vermillion's Cancer Diagnostic Program 135
7.8 Hepsin 135
7.9 Hologic Gen-Probe's PCA3 Assay 135
7.10 Early Prostate Cancer Antigen-2 (EPCA-2) 136
7.11 New and Novel Methods for Detection of Prostate Cancer 137
7.12 Mass Spectrometry 137
7.13 Summary 139

8. Bladder Cancer 140
8.1 Overview 140
8.2 Incidence and Mortality Rates 140
8.2.1 Incidence Rates 140
8.2.2 Mortality Rates 140
8.3 Progression and Recurrence 140
8.3.1 Bladder Cancer Risk Factors 141
8.3.2 Bladder Cancer Symptoms 141
8.4 Bladder Cancer Tests 141
8.5 UroVysion Bladder Cancer Kit (Abbott Molecular) 142
8.6 The oncoFISH Bladder (Ikonisys) 142
8.6.1 The CellOptics Platform (Ikonisys) 142
8.6.2 Cell Staining and Genetic Characterization 143
8.6.3 Ikoniscope/IkoniLAN Automated Microscopy 143
8.7 Nuclear Matrix Protein Markers 143
8.8 ImmunoCyt/uCyt+ 146
8.9 Bladder Cancer Market 147
8.9.1 Urologist Market 147
8.9.2 Clinical Lab Market 147
8.9.3 Primary Care Market 147
8.9.4 Private and Public Sector Markets 148
8.9.5 POC Market 148
8.9.6 Market Distribution 150
8.9.7 Reimbursement 151

9. Colorectal Cancer 152
9.1 Overview 152
9.2 Incidence and Mortality Rates 152
9.2.1 Incidence Rates 152
9.2.2 Mortality Rates 152
9.2.3 Progression and Recurrence 152
9.3 Screening for CRC 154
9.3.1 Stool-Based DNA Screening 155
9.4 Almac Diagnostics DSA 156
9.5 Colon Cancer Program (NMP35) 157
9.6 Myriad Genetics COLARIS AP Risk Assessment 158
9.7 Summary 158

10. Genetic Diagnostics Set to Revolutionize Cancer Diagnostic Testing 159
10.1 Overview 159
10.1.1 Clinicians' Need for More Information with Regard to Therapeutic Treatment Drives Demand for Pharmacogenomic Testing 159
10.1.2 Predictive Medicine Shows Potential for Genetic Diagnostics 159
10.1.3 Different Rates of Growth 160
10.1.4 Effective Competitive Strategies 160
10.1.5 Improvements in Marketing Effectiveness 160
10.1.6 Emerging Technologies Imply Start of a New Era and Offer Tremendous Growth Opportunities 161
10.1.7 Increased Market Share 161
10.1.8 Technologies Used in Genetic Testing 161
10.2 AMAS Test 161
10.3 Corixa (now GSK) Antibodies as Tumor Markers 161
10.4 CytoVision 162
10.5 Ariol System 162
10.6 Mammaglobin Protein Expression 162
10.7 L523S or KOC RNA Binding Protein 163
10.8 CA1-18 from EDP Biotech Corporation 163

11. Leukemia Biomarkers 164
11.1 Overview 164
11.2 Incidence and Mortality Rates 164
11.2.1 Incidence Rates 164
11.2.2 Mortality Rates 164
11.3 Progression and Recurrence 164

12. Lung Cancer 166
12.1 Introduction 166
12.2 Incidence and Mortality Rates 166
12.2.1 Incidence Rates 166
12.2.2 Mortality Rates 166
12.3 Lung Cancer Diagnostic Tests 167

13. Enabling Technologies for Oncology Biomarker Discovery 168
13.1 Automated Cellular Imaging System (ACIS III) 168
13.1.1 ACIS for HER2 Protein Expression Testing 169
13.1.2 ACIS for ER Protein Expression Testing 169
13.1.3 ACIS for PR Protein Expression Testing 170
13.1.4 ACIS for Cell Proliferation Expression 170
13.1.5 ACIS for Protein Expression 170
13.1.6 ACIS for Protein Micrometastases in Bone Marrow 170
13.1.7 ACIS for Protein Micrometastases in Tissue 170
13.1.8 ACIS for TMA 170
13.1.9 ACIS for DNA Ploidy 170
13.1.10 ACIS for HPV 171
13.2 DNA Methylation 171
13.2.1 Differential Methylation Hybridization (DMH) 171
13.2.2 MIRA-Assisted Microarrays for DNA Methylation Analysis and Cancer Diagnosis 172
13.3 Proteomics 172
13.3.1 Proteomics Technologies for Cancer Marker Discovery 172
13.3.2 Validation of Candidate Biomarkers 173
13.3.3 Requirements Bringing a New Marker into the Market 173
13.3.4 Value Chain in the Development of New Cancer Biomarkers 174
13.4 Secreted Proteins as Cancer Biomarkers 174
13.4.1 Markers of Known Tissue Origin 174
13.4.2 Secreted Proteins as Low Abundance Markers 174
13.4.3 Secreted Proteins in Tissue and Blood 175
13.5 Non-coding RNAs as Potential Tumor Markers 175
13.5.1 miRNA Meets Microarray 175
13.5.2 Mimetics and Inhibitors 176
13.5.3 Clinical Patterns in Cancer 176
13.6 Architect TIMP-1 (Tissue Inhibitor of Metalloproteinases-1) Immunoassay for CRC Detection 176
13.7 Companies Developing Automated Microscope-Based Analysis Systems 176
13.8 Companies Developing Research Products for Tumor Cell Isolation 176
13.9 Companies Supplying Fluorescently Labeled Antibodies to Characterize Tumor Cells 176
13.10 PerkinElmer High-Throughput Platforms: AlphaScreen, AequoScreen, DELFIA and LANCE
Technologies 177

14. Biomarker Tests Co-Developed with Cancer Therapeutics as Companion Diagnostics 178
14.1 Sector Overview 178
14.2 Companion Diagnostics 180
14.3 EGFR for CRC and Camptostar (Irinotecan) 180
14.3.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 180
14.3.2 Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL 181
14.3.3 EGFR Express and Erbitux (Cetuximab) 181
14.4 Companions Based on Myriad's IVDMIA Technology 181
14.4.1 Myriad's TheraGuide 5-Fluorouracil (5-FU) 181
14.4.2 BRACAnalysis Test 182
14.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 183
14.5.1 TheraScreen: EGFR29 183
14.5.2 The K-RAS Mutation Detection Kit 183
14.8 Drivers and Barriers to Companion Diagnostics 183
14.9 Partnerships with Pharma Companies to Identify Therapeutic Targets 184
14.10 Future Developments for Companion Diagnostics 185

15. Companion Diagnostics and Personalized Medicine: Biology, Approaches, Pipeline and
Regulatory Trends 187
15.1 Scope of This Chapter 187
15.2 Introduction to Companion Diagnostics and Personalized Medicine 187
15.2.1 Stakeholders in Companion Diagnostics 187
15.2.2 Development of Stakeholders' Business Models for Companion Diagnostics for Personalized
Medicine 189
15.2.2.1 Pharmaceutical Company Business Models for Developing Companion Diagnostics Products 189
15.2.2.2 Diagnostic Company Business Models for Developing Companion Diagnostics Products 190
15.2.2.3 Life Science Company Business Models for Developing Companion Diagnostics Products 190
15.2.2.4 Pharmacy Benefit Management Company Business Models for Developing Companion Diagnostics Products 191
15.2.3 Trends in Companion Diagnostic Deals 192
15.2.3.1 Market Size of Companion Diagnostics 193
15.2.4 Companion Diagnostics: Industry SWOT Analysis 200
15.2.5 Challenges for Companion Diagnostics Development 200
15.2.6 Timeline for Impact of Various Segments in Companion Diagnostics 202
15.2.7 Use of Proteomics to Develop Individualized Tests 204
15.3 The Compelling Case for Personalized Medicine 206
15.4 Drug Metabolism and Implications for Companion Diagnostics and Personalized Medicine 207
15.5 Examples of Personalized Medicine 211
15.6 Personalized Medicine and Companion Diagnostics Testing Product Pipeline 215
15.7 The Personalized Medicine Coalition 216
15.8 Regulatory Trends and Guidelines in the Personalized Medicine Space 221
15.8.1 The Changing Regulatory Landscape for Personalized Medicine 222
15.9 Patenting Personalized Medicine 223
15.10 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine and Companion Diagnostics are Appropriate and Being Deployed 226
15.10.1 EGFR Assay 226
15.10.2 UGT1A1 Molecular Assay for Camptosar 227
15.10.3 Response to Gleevec in Gastrointestinal Stromal Tumors 227
15.10.4 LabCorp and Qiagen and Personalized Medicine for the treatment of Colorectal Cancer 227
15.10.5 Labcorp and ARCA Discovery, Inc. and Personalized Medicine for Cardiovascular Disease 228
15.11 Companion Diagnostics and Personalized Medicine: Qualitative and Quantitative Market
Analysis 228
15.11.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics and Personalized
Medicine 229
15.11.2 Diagnostics vs. Pharmaceuticals 230
15.11.3 Molecular Diagnostic Market 230
15.11.4 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine 233
15.12 Snapshot of Companion Diagnostics Industry Structure 235
15.13 The Case for Theranostics (Therapeutic/Companion Diagnostic) 236
15.14 Personalized Medicine Market Analysis—Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 237
15.15 How the Market Segregates Today 238
15.16 Timeline for Impact of Various Segments in Personalized Medicine 239
15.17 Challenges for Personalized Therapeutics and Companion Diagnostics Development 241
15.18 Macro Trends in Personalized Medicine 242
15.19 Personalized Medicine and Companion Diagnostics: Industry SWOT Analysis 245

16. Business Trends in the Industry 247
16.1 Industry Consolidation 247
16.2 Breadth of Product Offering and Pricing 248
16.3 Government Regulation of Medical Devices 248
16.3.1 FDA Guidance on Drug Test Co-Development 250
16.4 Strategic Business and Marketing Considerations 250
16.5 Commercial Opportunities in Cancer Markers 251
16.5.1 Licensing and Intellectual Property Constraints and how they will Impact New Product
Development 252
16.6 Moderators of Growth 252
16.6.1 Roadblocks to Integrating Cancer Biomarkers into Clinical Practice 253
16.7 Biotechnology Industry Trends 253
16.8 Pharmaceutical Industry Trends 254
16.9 Sales and Marketing Strategies for Tumor Marker Tests 254
16.9.1 North American Market 255
16.9.2 International Markets 256
16.9.2.1 Europe 256
16.9.2.2 Central and South America 257
16.9.2.3 Asia-Pacific 257
16.10 Product Commercialization 258
16.11 Reimbursement 259
16.12 Self Referral Rules 260
16.13 Health Insurance Portability and Accountability Act 261
16.14 Clinical Laboratory Improvement Amendments 261
16.15 In Vitro Diagnostic Directive and Medical Device Regulations 262
16.16 FDA's Quality System Regulation 262
16.17 FDA's OIVD on IVDMIAs 263
16.18 FDA Approval Process for Protein-Based Biomarkers 264
16.18.1 Classification of Protein-Based Biomarker Assays as Medical Devices 264
16.18.2 Clinical and Analytical Requirements for Biomarker Performance 265
16.18.3 Approval Process Workflow 267
16.19 Genetic Tests and Medical Records 267
16.19.1 Laws Against Genetic Discrimination 268
16.20 Medicare Reimbursement 269
16.20.1 Medicare Spending Trends 269
16.21 Global Drivers of Clinical Laboratory Testing 271
16.22 Global Outlook for Cancer Biomarkers 271
16.22.1 Which Companies are Utilizing Cutting-Edge Technologies to Develop, Validate and Implement Cancer Biomarkers for Clinical Use? 272
16.22.2 What Impediments Still Exist to Incorporating Promising Research into Clinical Practice? 272
16.22.3 Which Biomarkers Show the Most Promise for Approval? 273
16.22.4 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 273
16.22.5 Which Alliances Show the Greatest Synergy in Bringing Valid Biomarkers to Market? 273
16.22.6 Which Shared Technologies are Driving the Most Encouraging Development? 273
16.22.7 How Strategic Alliances and Interdisciplinary Involvement Drive Development and Implementation of Emerging Biomarker Technologies 274
16.23 Oncology Biomarker Qualification Initiative 274
16.24 FDA Critical Path 275
16.25 FDA Criteria for a Valid Biomarker 275

17. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms 276
17.1 Abbott Diagnostics 276
17.2 Affymetrix, Inc. 279
17.3 Agendia BV 286
17.4 Agensys, Inc. (Astellas Pharma US) 288
17.5 Agilent Technologies 289
17.6 Almac Group 290
17.7 AMDL, Inc. 292
17.8 Asuragen, Inc. 293
17.9 Aureon Laboratories, Inc. 294
17.10 Beckman Coulter, Inc. 295
17.11 Biocode Hycel S.A. 299
17.12 BioCurex, Inc. 299
17.13 Biomarker Technologies, LLC 300
17.14 Biomedical Diagnostics, LLC 300
17.15 Biomerica, Inc. 301
17.16 bioMerieux 302
17.17 Biomira, Inc. (Oncothyreon, Inc.) 303
17.18 Biomoda, Inc. 303
17.19 Bruker Daltonics, Inc. 304
17.20 Byk Gulden 305
17.21 Cangen Biotechnologies, Inc. 305
17.22 Caprion Proteomics 306
17.23 Celera Diagnostics 309
17.24 Cepheid 309
17.25 Clarient, Inc. (GE Healthcare) 311
17.26 Claros Diagnostics, Inc. 312
17.27 Clinical Data, Inc.: PGxHealth and Cogenics 312
17.28 Correlogic Systems, Inc. 314
17.29 CytoCore, Inc. (Formerly Molecular Diagnostics, Inc.) 315
17.30 Cytogen Corporation (now EUSA Pharma) 316
17.31 Dako (Agilent Technologies) 318
17.32 diaDexus, LLC 319
17.33 DiagnoCure, Inc. 320
17.34 DRG International, Inc. 322
17.35 EDP Biotech Corporation 323
17.36 Eisai Co., Ltd. 324
17.37 Eli Lilly and Co. 324
17.38 Epigenomics 325
17.39 Exact Sciences Corporation 326
17.40 Exagen Diagnostics, Inc. 326
17.41 Exigon 327
17.42 Gene Logic, Inc. 327
17.43 Genesis Genomics, Inc. (Mitomics) 328
17.44 GenMark Diagnostics 329
17.45 Genomic Health, Inc. 330
17.46 Gen-Probe, Inc. (now known as Hologic Gen-Probe) 331
17.47 Health Discovery Corporation 336
17.48 Ikonisys, Inc. 337
17.49 Illumina 337
17.50 Immunomedics, Inc. 339
17.51 Incyte Pharmaceuticals, Inc. 341
17.52 InterGenetics, Inc. 341
17.53 Ipsogen (Qiagen Marseille) 341
17.54 Janssen Diagnostics 342
17.55 LabCorp 343
17.56 Life Technologies Corporation (Thermo Fisher Scientific) 344
17.57 Matritech, Inc. (Alere) 347
17.58 Miraculins, Inc. 348
17.59 Mitsubishi Kagaku Medical 349
17.60 MolecularMD 349
17.61 Myriad Genetics, Inc. 350
17.62 NimbleGen Systems, Inc. 355
17.63 Northwest Biotherapeutics, Inc. 355
17.64 Oncotech, Inc. (Exiqon A/S) 356
17.65 Oncothyreon, Inc. (Formerly known as Biomira) 357
17.66 OPKO Health, Inc. 359
17.67 Orion Genomics 361
17.68 Oxford BioTherapeutics (Formerly Oxford Genome Sciences) 362
17.69 Panacea Pharmaceuticals, Inc. 363
17.70 Polymedco, Inc. 363
17.71 Power3 Medical Products 364
17.72 Qiagen N.V. 364
17.73 Roche Molecular Diagnostics 368
17.74 SensiGen, LLC (Sequenom Center for Molecular Medicine) 370
17.75 Siemens Healthcare Diagnostics, Inc. 371
17.76 Upstream Biosciences, Inc. 372
17.77 Ventana Medical Systems, Inc. (Part of the Roche Group) 373
17.78 Veridex, LLC (Janssen Diagnostics, LLC) 374
17.79 Vermillion, Inc. (Formerly Ciphergen) 375

Appendix 1: Cancer Biomarker Centers of Research 377
Appendix 2: Myriad Patents on Genes BRCA-1 and BRCA-2 378
Appendix 3: Cancer Markers Currently in Common Clinical Use 379
Appendix 4: International Federation of Gynecology and Obstetrics (FIGO) Staging System for Primary Carcinoma of the Ovary 380
Appendix 5: FDA Guidance for Industry: Pharmacogenomic Data Submission 381
A5.1 Introduction 381
A5.2 Background 381
A5.3 Submission Policy 382
A5.3.1 General Principles 382
A5.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling 384
A5.3.3 Benefits of Voluntary Submissions to Sponsors and FDA 385
A5.4 Submission of Pharmacogenomic Data 386
A5.4.1 Submission of Pharmacogenomic Data During the IND Phase 386
A5.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement 387
A5.4.3 Submission to a Previously Approved NDA or BLA 388
A5.4.4 Compliance with 21 CFR Part 58 388
A5.4.5 Submission of Voluntary Genomic Data from Application-Independent Research 388
A5.5 Format and Content of a VGDS 389
A5.6 Process for Submitting Pharmacogenomic Data 390
A5.7 Agency Review of VGDSs 390
Appendix 6: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions 392
A6.1 Introduction 392
A6.2 Background 392
A6.3 Scope 392
A6.4 General Principles 392
A6.5 Structure of Biomarker Qualification Submissions 393

Glossary 400


INDEX OF FIGURES

Figure 3.1: Potential Market for Cancer Biomarkers 28
Figure 3.2: Segmentation of the Cancer Biomarkers Marketplace Based on Commercial Offerings—Products and Services 31
Figure 3.3: Geographical Distribution of Cancer Tumor Diagnostic Testing 35
Figure 3.4: Cancer Biomarkers Research Market, 2006-2016 43
Figure 3.5: Breast Cancer Biomarker Market Potential, 2010 49
Figure 3.6: Challenges in the Study or Utilization of Proteomic Cancer Biomarkers 50
Figure 3.7: Challenges in the Study or Utilization of Companion Diagnostic Cancer Biomarkers 50
Figure 3.8: Challenges in the Study or Utilization of Serum Cancer Markers 51
Figure 3.9: Top Unmet Needs in Commercial Products in the Cancer Biomarkers Space 52
Figure 5.1: Hybridization Process 85
Figure 5.2: FISH Test Procedure 85
Figure 5.3: Gene Expression Profiling 96
Figure 15.1: Strategic and Tactical Considerations for Co-Development of Companion Diagnostics 192
Figure 15.2: Global Market for Companion Diagnostics 193
Figure 15.3: Number of Companion Diagnostic Agreements, 2000-2013 194
Figure 15.4: Surface Binding Produces Phase Shifts that Increases the Diffraction Signal Intensity 205
Figure 15.5: Phase I and II Processes of Drug Metabolism 207
Figure 15.6: Human Phase I Enzymes 208
Figure 15.7: Human Phase II Enzymes 208
Figure 15.8: Hepatic Distribution of Human CYP450 209
Figure 15.9: Relative Contribution of CYP450 Enzymes to Drug Metabolism 209
Figure 15.10: Genetic Components Determine Drug Metabolism 210
Figure 15.11: From Genetic Content to Personalized Medicine 229
Figure 15.12: Remuneration for Diagnostics 230
Figure 15.13: Breakout of the Molecular Diagnostics Marketplace 231
Figure 15.14: Molecular Diagnostics Market Segmentation 232
Figure 15.15: Molecular Diagnostics Market Segmentation by Technology 233
Figure 15.16: Market Survey Respondent Demographics 237
Figure 15.17: Breakout of the Respondent Pool by Affiliation 238
Figure 15.18: Segmentation of the Personalized Medicine Market 238
Figure 15.19: Personalized Medicine Market Drivers 242
Figure 15.20: Challenges in the Personalized Medicine Space 243
Figure 16.1: Medicare Spending on Clinical Laboratory Services per Enrollee, 2003-2016 269

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  • August 2016
  • by BCC Research

This BCC Research report explores the current and future PCR product market, which includes instruments, reagents and consumables, and software and services. It also looks at innovations, market drivers ...


ref:plp2014

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