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Molecular Diagnostics in Cancer Testing

  • June 2016
  • -
  • TriMark Publications
  • -
  • 201 pages

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays.

These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

Table Of Contents

Molecular Diagnostics in Cancer Testing
1. Overview 10
1.1 Statement of Report 10
1.2 About This Report 10
1.3 Scope of the Report 11
1.4 Objectives 11
1.5 Methodology 11
1.6 Executive Summary 13

2. Introduction to Molecular Diagnostics 20
2.1 Opening of Opportunities in Molecular Diagnostics 20
2.2 Impact of the Human Genome Project on Molecular Diagnostics 22
2.3 Considerations for Molecular and Clinical Diagnostics 23
2.4 Molecular Diagnostics in the Post-Genomic Era 25
2.5 Advances in Molecular Diagnostics Technologies 26
2.5.1 Molecular Methods to Detect Genetic Variants in Cancer 27
2.5.1.1 Allele-Specific PCR 29
2.5.1.2 Sanger Dideoxy Sequencing 29
2.5.1.3 Pyrosequencing 30
2.5.1.4 Mass Spectrometry 30
2.5.1.5 Single Base Extension Assay 30
2.5.1.6 Multiplex Ligation-Dependent Probe Amplification (MLPA) 31
2.5.1.7 Fluorescence In Situ Hybridization (FISH) 31
2.5.1.8 Next Generation Sequencing 31
2.5.1.8.1 Next-Generation Sequencing—Custom Panels, Amplicon Capture 32
2.5.1.8.2 Next-Generation Sequencing—Custom Panels, Hybridization Capture 32
2.5.1.8.3 Next-Generation Sequencing—Whole Exome Sequencing 33
2.5.1.8.4 Next-Generation Sequencing—Whole Genome Sequencing 33
2.5.1.9 Digital Droplet PCR (ddPCR) 33
2.5.2 Clinical Applications of Next-generation Sequencing 35
2.6 Oligonucleotide Array Platforms 36
2.7 Emerging Cancer Personalized Medicine Market 37
2.7.1 Predictive Cancer Molecular Diagnostics 40
2.8 Companion Diagnostics 41
2.9 Opportunities for Molecular Diagnostic Companies 50
2.10 Liquid Biopsies 51
2.11 Data Analysis 51
2.12 In-house vs. Commercial Testing 52
2.13 Multi-Gene Cancer Panels 53

3. Cancer Diagnostics Molecular Testing Market 54
3.1 Market Description 54
3.1.1 Market Overview for Molecular Diagnostics in Cancer Testing 54
3.1.2 Laboratories Performing Molecular Diagnostics for Cancer Testing 57
3.1.3 Competitive Landscape 59
3.1.3.1 Pure Play Specialty Companies Performing Tumor MDx Analysis 59
3.1.3.2 Mixed Specialty Cancer Diagnostic Labs 60
3.1.3.3 General Clinical Reference Laboratories 60
3.1.3.4 Diagnostic Device and Reagent Developers 61
3.1.3.5 Companion Diagnostics Development in Partnership with a Pharmaceutical Company 61
3.1.4 Sales and Marketing Strategies for Cancer Tests 62
3.1.4.1 North American Market 63
3.1.4.2 International Markets 64

4. Molecular Diagnostic Tests for Cancer 66
4.1 Overview of Molecular Diagnostics for Cancer 66
4.1.1 Cancer Statistics 66
4.1.2 Treating Cancers 67
4.1.3 Use of Genomics to Understand Cancer 68
4.1.4 Molecular Diagnostic Tools Solutions 70
4.1.5 Technology of Gene Expression Analysis 72
4.1.5.1 Amplify and Detect Diminished Amounts of RNA Consistently 72
4.1.5.2 Analyze Hundreds of Genes 72
4.1.5.3 Employ Advanced Information Technology 73
4.2 Breast Cancer Molecular Diagnostics 73
4.2.1 Overview of Breast Cancer 73
4.2.2 Breast Cancer Molecular Diagnostic Assays 76
4.2.2.1 Ambry Genetics 77
4.2.2.2 Agendia 78
4.2.2.2.1 MammaPrint 78
4.2.2.3 BGI 80
4.2.2.4 Bioreference Labs 80
4.2.2.5 BioTheronostics (part of BioMerieux) 81
4.2.2.5.1 Breast Cancer Index 81
4.2.2.6 Cancer Genetics, Inc. (CGI) 81
4.2.2.7 Dako (part of Agilent Technologies) 82
4.2.2.8 DiaSorin 82
4.2.2.9 Fulgent Diagnostics 82
4.2.2.10 Genetic Technologies Ltd. 82
4.2.2.11 Genomic Health 83
4.2.2.11.1 Oncotype DX 83
4.2.2.12 Genoptix (part of Novartis) 84
4.2.2.13 Invitae 85
4.2.2.14 LabCorp 85
4.2.2.14.1 BRCAssure® Tests 86
4.2.2.15 Multiplicom 86
4.2.2.16 Myriad Genetics 86
4.2.2.16.1 BRACAnalysis® 87
4.2.2.16.2 BART® 87
4.2.2.17 Nanostring Technologies 87
4.2.2.17.1 Prosigna 87
4.2.2.18 Neogenomics 88
4.2.2.19 Pathway Genomics 88
4.2.2.20 Sophia Genetics 88
4.2.2.21 Quest Diagnostics 88
4.2.2.21.1 BRCAvantage Plus 88
4.2.2.22 Ventana Medical Systems (Roche) 89
4.2.2.22.1 HER2 Dual ISH DNA Probe Cocktail, INFORM 89
4.2.3 Competitive Structure and Market Share Analysis 89
4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 91
4.2.3.1.1 Global Market 91
4.2.3.1.2 U.S. Market 91
4.2.3.1.3 European Market 91
4.2.4 Market Drivers and Restraints 92
4.2.4.1 Market Drivers 92
4.2.4.2 Market Restraints 92
4.2.5 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 93
4.2.5.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 93
4.2.5.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 93
4.2.5.3 Breast Cancer Testing Assay Strategic Recommendations 93
4.3 Colorectal Cancer Molecular Diagnostics Market 94
4.3.1 Overview of Colorectal Cancer 94
4.3.2 Colon Cancer Molecular Diagnostic Assays 95
4.3.2.1 BRAF 96
4.3.2.2 KRAS 96
4.3.2.3 mSEPT9 98
4.3.2.4 Screening Assays 99
4.3.2.4.1 Overview of Stool-based DNA Assays 99
4.3.2.5 Abbott 101
4.3.2.5.1 Abbott RealTime KRAS Amplification Reagent Kit 101
4.3.2.5.2 RealTime mS9 Colorectal Cancer 101
4.3.2.6 Agendia 101
4.3.2.6.1 ColoPrint 101
4.3.2.7 Ambry Genetics 102
4.3.2.7.1 ColoNext 102
4.3.2.8 Bioreference Labs 102
4.3.2.9 Cancer Genetics, Inc. 102
4.3.2.10 Epigenomics 103
4.3.2.10.1 Epi proColon 103
4.3.2.11 Exact Sciences 104
4.3.2.11.1 Cologuard 104
4.3.2.12 Fulgent Diagnostics 104
4.3.2.13 Genomic Health 105
4.3.2.13.1 Oncotype DX colon 105
4.3.2.14 Genomictree 105
4.3.2.15 Genoptix (part of Novartis) 105
4.3.2.16 Invitae 106
4.3.2.17 LabCorp 106
4.3.2.18 Myriad Genetics 107
4.3.2.18.1 COLARIS 107
4.3.2.18.2 COLARIS AP 107
4.3.2.19 Neogenomics 109
4.3.2.20 Novigenix 109
4.3.2.20.1 Colox 109
4.3.2.21 Pathway Genomics 109
4.3.2.21.1 ColoTrue 109
4.3.2.22 Qiagen 109
4.3.2.22.1 therascreen KRAS RGQ PCR Kit 109
4.3.2.23 Quest Diagnostics 110
4.3.2.23.1 ColoVantage 110
4.3.2.24 Roche 110
4.3.2.24.1 cobas® KRAS Mutation Test 110
4.3.2.25 Trovagene 110
4.3.2.25.1 PCM KRAS Mutation Detection Test 110
4.3.3 Competitive Structure and Market Share Analysis 111
4.3.3.1 Colorectal Cancer Molecular Diagnostic Testing Market Size 111
4.3.3.2 Market Drivers and Restraints 112
4.3.3.2.1 Market Drivers 112
4.3.3.2.2 Market Restraints 113
4.3.3.3 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 113
4.3.3.3.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 113
4.3.3.3.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 113
4.3.3.3.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 114
4.3.4 New Guidelines for Colorectal Cancer Molecular Testing 115
4.4 Prostate Cancer Molecular Diagnostics Market 115
4.4.1 Molecular Screening Assays for Prostate Cancer 116
4.4.1.1 Hologic 117
4.4.1.1.1 PROGENSA PCA3 Assay 117
4.4.1.2 Bostwick Laboratories 118
4.4.1.2.1 PCA3Plus 118
4.4.1.3 Overview of PCA3 118
4.4.1.4 MDx Health 120
4.4.1.4.1 SelectMDx for Prostate Cancer 120
4.4.1.5 Invitae 120
4.4.1.5.1 Invitae Prostate Cancer Panel 120
4.4.1.6 Neogenomics 120
4.4.1.6.1 NeoLAB Prostate 120
4.4.2 Molecular Assays Performed After Colorectal Biopsy 121
4.4.2.1 Myriad Genetics 121
4.4.2.1.1 Prolaris 121
4.4.2.2 Genomic Health 121
4.4.2.2.1 Oncotype DX Genomic Prostrate Score 121
4.4.2.3 MDxHealth (ConfirmMDx) 122
4.4.2.4 Bostwick Laboratories (ProstaVysion) 122
4.4.3.5 MDNA Life Sciences 123
4.4.3.5.1 Prostate Core Mitomic Test 123
4.4.2.6 GenomeDx 124
4.4.2.6.1 Decipher 124
4.4.3 Competitive Structure and Market Share Analysis 124
4.4.4 Market Drivers and Restraints 125
4.4.4.1 Market Drivers 125
4.4.4.2 Market Restraints 125
4.4.5 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 126
4.4.5.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends 126
4.4.5.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends 127
4.5 Ovarian Cancer 127
4.5.1 Incidence of Ovarian Cancer 127
4.5.2 Key Players in Ovarian Testing Market 128
4.5.2.1 Ambry Genetics 128
4.5.2.2 Myriad Genetics 129
4.5.2.3 Market Drivers and Restraints 129
4.5.2.3.1 Market Drivers 129
4.5.2.3.2 Market Restraints 130
4.6 Lung Cancer 130
4.6.1 Incidence of Lung Cancer 130
4.6.2 Pharmacogenomics and Cancer 132
4.6.3 Lung Cancer Molecular Diagnostics Assays 134
4.6.3.1 Genoptix (a Novartis company) 134
4.6.3.1.1 NexCourse NSCLC 134
4.6.3.2 Qiagen 134
4.6.3.2.1 therascreen EGFR RGQ PCR Kit 134
4.6.3.3 Roche 135
4.6.3.3.1 cobas® EGFR Mutation Test v2 135
4.6.3.4 Epigenomics 136
4.6.3.4.1 Epi proLung® BL Reflex Assay 136
4.6.3.5 Myriad Genetics 136
4.6.3.5.1 myPlanâ„¢ Lung Cancer 136
4.6.3.6 Quest Diagnostics 137
4.6.3.6.1 Lung Cancer Mutation Panel 137
4.6.3.7 Rosetta Genomics 137
4.6.3.7.1 OncoGxLung 137
4.6.3.8 Trovagene 137
4.6.3.8.1 PCM EGFR Mutation Detection Test 137
4.6.3.9 Veracyte, Inc. 138
4.6.3.9.1 Percepta 138
4.6.3.10 Accugenomics 138
4.6.3.10.1 Lung Cancer Risk Test (LCRT-AGX) 14 Gene Test 138
4.6.4 Competitive Space 139
4.7 Melanoma 139
4.7.1 bioMerieux 140
4.7.1.1 THxIDâ„¢ BRAF 140
4.7.2 Roche 141
4.7.2.1 cobas® 4800 BRAF V600 Mutation Test 141
4.7.3 Myriad 141
4.7.3.1 myPathâ„¢ Melanoma 141
4.7.4 Trovagene 141
4.7.4.1 PCM BRAF Mutation Detection Test 141
4.8 Molecular Diagnostic Assays for Other Types of Cancers 142
4.8.1 Accugenomics 142
4.8.1.1 Standardized BCR-ABL Molecular Diagnostics Test 142
4.8.2 Ambry Genetics 142
4.8.2.1 PancNext 142
4.8.2.2 PGLNext 142
4.8.2.3 RenalNext 143
4.8.3 Asuragen 143
4.8.3.1 QuantideX® qPCR BCR-ABL IS Kit 143
4.8.4 DiaSorin 143
4.8.4.1 PML-RARA Detection bcr1,3 and Discrimination bcr2 143
4.9 Panels Testing Multiple Cancers 144
4.9.1 Ambry Genetics 144
4.9.1.1 CancerNext 144
4.9.1.2 CancerNext-Expanded 144
4.9.2 Biotheranostics 144
4.9.2.1 CancerTYPE ID 144
4.9.3 Cancer Genetics, Inc. (CGI) 144
4.9.4 Color Genomics 146
4.9.4.1 Color Test 146
4.9.5 Counsyl Labs 146
4.9.6 Guardant Health 146
4.9.7 Multiplicom 147
4.9.7.1 SOMATIC 1 MASTRâ„¢ Plus Dx 147
4.9.8 Myriad Genetics 147
4.9.8.1 myRiskâ„¢ Hereditary Cancer 147
4.9.9 Pathway Genomics 147
4.9.9.1 CancerInterceptâ„¢ Detect 147
4.9.10 Quest Diagnostics 148
4.9.10.1 OncoVantage® Solid Tumor Mutation Analysis 148
4.9.11 Rosetta Genomics 148
4.9.11.1 OncoGxOneâ„¢ 148
4.10 Potential new Entrants to the Market 148
4.10.1 Illumina 148
4.10.2 Metabiomics 148
4.10.3 Orion Genomics 149
4.10.4 Siemens 149
4.10.5 VolitionRx 149

5. Business 151
5.1 Technology and Market Trends 151
5.1.1 Technology Trends 152
5.1.2 Market Trends 152
5.2 MandA Activity 154
5.3 Partnerships 156
5.4 Summary of Market Strengths, Weaknesses, Opportunities and Threats 158
5.4.1 Industry Challenges and Strategic Recommendations 159
5.4.2 Commercialization of Molecular Diagnostic Products 159
5.5 Intellectual Property Rights 160
5.5.1 BRCA1 and BRCA2 Gene Patents 161
5.5.2 Current Patent Disputes 161

6. Reimbursement and Billing 163
6.1 Overview 163
6.2 Trends in Reimbursement Practice 163
6.2.1 Medicare Reimbursement 163
6.2.2 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules 166
6.3 Trends in Patient Care and Reimbursement 166
6.4 Revenue Threats 167
6.4.1 Three Areas for Denial of Claims by Biomarkers 169
6.5 Billing 169
6.5.1 Medicare Billing Procedures 170
6.5.2 Medicare CPT Coding Rules for Cancer Biomarkers 170

7. Government Regulation 172
7.1 U.S. Food and Drug Administration 172
7.2 CLIA Regulations 173
7.3 Clinical Laboratory Improvement Act 173
7.4 State Licensing for Service Laboratories 175
7.5 510(k) Clearance 175
7.6 Pre-Market Approval 175
7.7 ASRs 175
7.8 What Regulatory Guidance is Needed for Companion Biomarkers? 176
7.9 U.S. Patent and Trademark Office 177
7.10 IRB Approval in Clinical Trials 177
7.11 Microarray Quality Control 177
7.12 ER and PR Proficiency Testing 178

8. Company Profiles 179
8.1 Abbott Molecular Diagnostics 179
8.2 AccuGenomics, Inc. 179
8.3 Agendia 179
8.4 Ambry Genetics 180
8.5 Asuragen 180
8.6 BGI 180
8.7 Biodesix 181
8.8 bioMerieux 181
8.9 Bioreference Labs 182
8.10 bioTheranostics 182
8.11 Cancer Genetics, Inc. 182
8.12 Counsyl 185
8.13 Dako (an Agilent Technologies company) 185
8.14 DiaSorin 185
8.15 Epigenomics 185
8.16 Exact Sciences Corporation 186
8.17 Exiqon 186
8.18 Flatiron Health 187
8.19 Fulgent Diagnostics 187
8.20 Genomic Health, Inc. 187
8.21 Genomictree 188
8.22 Genoptix, Inc. (Novartis) 189
8.23 HTG Molecular Diagnostics 189
8.24 Guardant Health 189
8.25 Hologic 189
8.26 Illumina 189
8.27 Invitae 190
9.28 LabCorp 190
8.29 MDxHealth 191
8.30 Myriad Genetics, Inc. 192
8.31 Nanostring 193
8.32 Neogenomics 193
8.33 Nuvera Biosciences 194
8.34 Orion Genomics 194
8.35 Pathway Genomics 194
8.36 Qiagen 195
8.37 Quest Diagnostics 195
8.38 Roche Molecular Systems 196
8.39 Rosetta Genomics Ltd. 197
8.40 Sophia Genetics 197
8.41 Trovagene 197

Appendix 1: Definition of Terms for Molecular Diagnostics 198
Appendix 2: Standard Cancer Therapeutic Panels 200


INDEX OF FIGURES

Figure 2.1: Finding Genes with Microassays 21
Figure 2.2: Use of Microassays for Studying Gene Expression 21
Figure 2.3: Finding New Drugs with Microarrays 22
Figure 2.4: Using DNA Microarrays to Compare Cancer and Normal Cells 22
Figure 2.5: Microarrays for Prediction of Survival in Cancer 24
Figure 2.6: ddPCR Using a Single Color Probe 34
Figure 2.7: ddPCR Using Two Probe Colors 34
Figure 2.8: BEAMing Method of ctDNA Detection 35
Figure 2.9: Using Gene Expression Patterns to Chose Treatment 37
Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2015 55
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing in the U.S., 2015 56
Figure 3.3: Market Share for Key Companies in the Global Molecular Diagnostics Cancer Testing Market 56
Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers 62
Figure 4.1: Using DNA Microassays to Measure Gene Expression 69
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 69
Figure 4.3: Action of Herceptin in Breast Cancer Patients 75
Figure 4.4: Analysis of Cancer Tissue by Microarray 79
Figure 4.5: HNPCC Mutation Increases Risk of Cancer 108
Figure 4.6: APC Mutation Increases Risk of Cancer 108
Figure 4.7: Prostate-Specific Membrane Antigen 116
Figure 4.8: PCA3 Score Nomogram 119
Figure 4.9: Ovarian Cancer Types 128
Figure 4.10: Targets for Therapy—Mutations Associated with Lung Cancer 133
Figure 4.11: Molecular Subsets of Lung Cancer 133
Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 157


INDEX OF TABLES

Table 2.1: Types of Molecular Tests and Types of Genetic Variants Detected 28
Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 37
Table 2.3: Targeted Drug Therapies for Cancers 38
Table 2.4: Select Genes and Cancer Risk 40
Table 2.5: Use of Cancer Biomarkers in Drug Development 42
Table 2.6: Utility of Biomarkers as Companion Diagnostics to Drug Development 42
Table 2.7: FDA Approved Companion Diagnostics 43
Table 2.8: Recommended Databases for Interpreting Somatic Mutation Results in Cancer 52
Table 3.1: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 54
Table 3.2: Global Market for Molecular Diagnostics Cancer Testing, 2012-2021 54
Table 3.3: U.S. Market for Molecular Diagnostics Cancer Testing, 2012-2021 55
Table 3.4: Molecular Diagnostic Markets for Cancer Testing, 2015 56
Table 3.5: Key Companies in the Global Molecular Diagnostics Cancer Testing Market 57
Table 3.6: Highlights of the Cancer Diagnostic Testing Segment 58
Table 3.7: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic
Services 58
Table 3.8: Business Factors Influencing Advanced Oncology Testing Services 58
Table 3.9: Strategies for Marketing Cancer Diagnostic Products 63
Table 3.10: Key Elements of MDx Diagnostic Companies Marketing Plan 63
Table 4.1: FDA Approved Cancer Tests 66
Table 4.2: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2016 66
Table 4.3: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2016 67
Table 4.4: Molecular Diagnostic Technologies 70
Table 4.5: Breast Cancer Overview 74
Table 4.6: Overview of HER2/neu and Herceptin 75
Table 4.7: Key Players in the Breast Cancer Molecular Diagnostic Space 76
Table 4.8: FDA-Approved Breast Cancer Molecular Diagnostic Tests on the Market 77
Table 4.9: MammaPrint: Key Features 80
Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX 84
Table 4.11: Oncotype DX Overview 84
Table 4.12: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic
Tests, 2015 90
Table 4.13: Global Market for Breast Cancer Molecular Diagnostic Testing, 2012-2021 91
Table 4.14: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2012-2021 91
Table 4.15: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of
Impact 92
Table 4.16: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of
Impact 92
Table 4.17: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market 93
Table 4.18: Colorectal Cancer Overview 95
Table 4.19: Key Players in the Breast Cancer Molecular Diagnostic Space 95
Table 4.20: FDA-Approved and/or CE-marked Colorectal Cancer Molecular Diagnostic Tests on the
Market 96
Table 4.21: KRAS Assays by Analytical Type 97
Table 4.22: KRAS Mutation Analysis Summary 98
Table 4.23: KRAS and BRAF in Clinical Use 98
Table 4.24: Key Players in the Colorectal Cancer Molecular Diagnostic Space 100
Table 4.25: NexCourse CRC Test Offering and Treatment Direction 106
Table 4.26: Global Market for Molecular Diagnostic Colon Cancer Testing, 2012-2021 111
Table 4.27: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2012-2021 112
Table 4.28: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of
Impact 112
Table 4.29: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of
Impact 113
Table 4.30: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 114
Table 4.31: Stages in Prostate Cancer Discovery and Diagnosis 116
Table 4.32: Corporate Players in the Prostate Cancer Molecular Diagnostic Space 117
Table 4.33: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of
Impact 125
Table 4.34: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of
Impact 125
Table 4.35: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market 126
Table 4.36: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 129
Table 4.37: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 130
Table 4.38: Lung Cancer Survival Rates 130
Table 4.39: Lung Cancer Facts 131
Table 4.40: Pharmacogenetic Markers for Select Cancer Drugs 132
Table 4.41: Potential of Cancer Biomarkers in Drug Delivery and Development 133
Table 5.1: Technology Trends in Cancer Testing 152
Table 5.2: Trends in Theranostics 152
Table 5.3: Market Trends in Cancer Testing 153
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 153
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 154
Table 5.6: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care
Market 158
Table 5.7: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 159
Table 5.8: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges 159
Table 5.9: Key Elements for Business Competition in Gene Expression Profiling for Cancer 160
Table 6.1: Factors Determining Third-Party Payment for Advanced Cancer Tests 168
Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business 172
Table 7.2: Focus Areas for the FDA Critical Path Initiative 177

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