MediPoint: In-Vitro Colorectal Cancer Screening Tests - Current and Future Players

Summary

GlobalData has released its medical device report, “MediPoint: In-Vitro Colorectal Cancer Screening Tests - Current and Future Players”. The report is a vital source of up-to-date information with in-depth analysis on the companies in the steadily growing In-Vitro Colorectal Cancer Screening Tests Market. Colorectal cancer (CRC) is the third most commonly diagnosed cancer, and the second most common cause of mortality amongst cancer patients. Prognosis is directly related to early diagnosis, with survival rates dramatically improved by early diagnosis and treatment. Thanks to the introduction of CRC screening programs, mortality in the developed countries is falling; however incidence continues to rise as a result of diet and increasingly sedentary lifestyles. While historically, colorectal cancer incidence in the developing world is low, in recent years, disease diagnosis rates have dramatically increased, as a result of changing lifestyles, awareness and improved access to medical services. CRC screening can improve survival rates, and reduce the overall cost of patient treatment.

Scope

- Investigation of current and future market competition for In-Vitro Colorectal Cancer Screening Tests.
- Competitor assessment including device approval analysis.
- Coverage of key market players and company profiles including business description, financial overview and SWOT analysis.
- Strategic assessment of the device sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as interventional cardiologists and radiologists already using In-Vitro Colorectal Cancer Screening Tests in clinical practice.

Reasons to buy

- Gain a high level view of the trends shaping and driving the In-Vitro Colorectal Cancer Screening Tests market for coronary applications and peripheral applications in the lower extremity.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market

Table Of Contents

Table of Contents

1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 11
2 Introduction 12
2.1 Catalyst 12
3 Competitive Assessment 13
3.1 Overview 13
3.2 Fecal Occult Blood Tests 13
3.2.1 Guaiac Fecal Occult Blood Stool Tests 13
3.2.2 Lateral Flow Immuno-Fecal Occult Blood Tests 17
3.2.3 Readers 24
3.2.4 Immuno-FOB Test ELISA 27
3.2.5 Immuno-FOB Agglutination Tests 30
3.3 CRC DNA Screening Tests 40
3.3.1 Panel DNA Tests 40
3.3.2 Methylated Gene Testing 50
3.4 Other Biomarker Tests 59
3.4.1 Overview 59
3.4.2 Tumor M2-PK Stool Test/2-in-1 Quick Test 59
3.4.3 Transferrin Assays 61
4 Pipeline Products 63
4.1 Overview 63
4.2 Pipeline by Phases in Development 63
4.3 Pipeline Product Profiles 65
4.3.1 BST1 CRC Assay 65
4.3.2 Cologic 66
4.3.3 ColoGuard 68
4.3.4 Colon Cancer BEC Test 72
4.3.5 Colon MarCare Plex 73
4.3.6 Colox 76
4.3.7 CRC Bacterial Signature Assay 78
4.3.8 CRC Breath Test 79
4.3.9 Epi proColon 82
4.3.10 ExiQon MicroRNA Test 88
4.3.11 Gemini CRC Biomarker Assay 91
4.3.12 GenomicTree Methylated DNA Test 92
4.3.13 Measure Fecal Occult Blood Test 94
4.3.14 Metabiomics CRC Test 97
4.3.15 MiR-21 Test 99
4.3.16 Oncolite CR 101
4.3.17 PanC-Dx 103
5 Current and Future Players 106
5.1 Overview 106
5.2 Trends in Corporate Strategy 107
5.3 Company Profiles 107
5.3.1 Abbott Molecular 107
5.3.2 Alere 109
5.3.3 Beckman Coulter 112
5.3.4 Biomarcare Technologies 113
5.3.5 Companion Dx 115
5.3.6 Eiken Chemical 116
5.3.7 Epigenomics 119
5.3.8 Exact Sciences 124
5.3.9 ExiQon 128
5.3.10 Fujirebio (Miraca Holdings) 130
5.3.11 GeneNews 133
5.3.12 GenomicTree 134
5.3.13 Immunostics 136
5.3.14 Kyowa Medex 139
5.3.15 MDx Health (was OncoMethylome) 141
5.3.16 Merck Millipore 143
5.3.17 Metabiomics 145
5.3.18 Mode Diagnostics 147
5.3.19 Oncocyte (Bio Time) 149
5.3.20 Quest Diagnostics 151
5.3.21 R-Biopharm 155
5.3.22 Randox Laboratories 158
5.3.23 ScheBo Biotech 159
5.3.24 SciMarket Technologies 162
5.3.25 Siemens Healthcare 163
5.3.26 Signature Diagnostics 166
5.3.27 Sysmex 167
5.3.28 Veda Lab 169
6 Appendix 172
6.1 Abbreviations 172
6.2 Bibliography 175
6.3 Research Methodology 205
6.3.1 Coverage 205
6.3.2 Secondary Research 206
6.4 Physicians and Specialists Included in this Study 207
6.5 Primary Research 208
6.6 About the Authors 209
6.6.1 Analysts 209
6.6.2 Global Head of Healthcare 210
6.7 About GlobalData 211
6.8 Disclaimer 211




List of Tables

Table 1: CRC Screening Test Segmentation 13
Table 2: Guaiac Fecal Occult Blood Tests Product Profile 14
Table 3: Guaiac FOB Test SWOT Analysis, 2013 16
Table 4: Immuno-FOB Tests 21
Table 5: Product Profile - Lateral Flow Immunochemical Fecal Occult Blood Tests 23
Table 6: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, 2013 24
Table 7: Product Profile - Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) 25
Table 8: Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) SWOT Analysis, 2013 26
Table 9: Fecal Occult Blood ELISA Products 27
Table 10: Product Profile - Fecal Occult Blood ELISA 28
Table 11: Immuno-FOB Test ELISA SWOT Analysis, 2013 29
Table 12: Commercially Available Immuno-FOB Agglutination Test Systems 37
Table 13: Product Profile - Immuno-FOB Agglutination Tests 37
Table 14: Immuno-FOB Agglutination Tests SWOT Analysis, 2013 39
Table 15: Key Mutations Associated with CRC 41
Table 16: Key Stages of PCR Gene Test 42
Table 17: Product Profile - PreGen Plus 44
Table 18: PreGen Plus SWOT Analysis, 2013 45
Table 19: Product Profile - K-RAS, B-RAF, PIK3CA Array 46
Table 20: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, 2013 47
Table 21: Product Profile - Colonsentry 48
Table 22: Colonsentry SWOT Analysis, 2013 48
Table 23: Product Profile - Detector C 2.0 49
Table 24: Detector C SWOT Analysis, 2013 50
Table 25: Product Profile - ColoSure 53
Table 26: ColoSure SWOT Analysis, 2013 53
Table 27: Product Profile - MS9 55
Table 28: MS9 SWOT Analysis, 2013 56
Table 29: Septin-9 CRC Screening Marketed Laboratory-Developed Tests 56
Table 30: Product Profile - ColoVantage/Septin-9 57
Table 31: ColoVantage/Septin-9 SWOT Analysis, 2013 58
Table 32: Product Profile - Tumor M2-PK Stool Test/2-in-1 Quick Test 60
Table 33: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, 2013 61
Table 34: Product Profile - Transferrin Assays 62
Table 35: Transferrin Assays SWOT Analysis, 2013 62
Table 36: CRC Screening Tests Pipeline, 2012 64
Table 37: Product Profile - BST1 CRC Assay 65
Table 38: BST1 CRC Assay SWOT Analysis, 2013 66
Table 39: Product Profile - Cologic 67
Table 40: Cologic SWOT Analysis, 2013 68
Table 41: Product Profile - ColoGuard 70
Table 42: ColoGuard SWOT Analysis, 2013 72
Table 43: Product Profile - Colon Cancer BEC Test 73
Table 44: Colon Cancer BEC Test SWOT Analysis, 2013 73
Table 45: Product Profile - Colon MarCare Plex 74
Table 46: Colon MarCare Plex SWOT Analysis, 2013 75
Table 47: Product Profile - Colox 77
Table 48: Colox SWOT Analysis, 2013 78
Table 49: Product Profile - CRC Bacterial Signature Assay 79
Table 50: CRC Bacterial Signature Assay SWOT Analysis, 2013 79
Table 51: Product Profile - CRC Breath Test 81
Table 52: CRC Breath Test SWOT Analysis, 2013 81
Table 53: Product Profile - Epi proColon 84
Table 54: Epi proColon Clinical Trials 84
Table 55: Epi proColon SWOT Analysis, 2013 88
Table 56: ExiQon MicroRNA Sensitivity and Specificity 89
Table 57: Product Profile - ExiQon microRNA Test 89
Table 58: ExiQon microRNA Test SWOT Analysis, 2013 90
Table 59: Product Profile - Gemini CRC Biomarker Assay 91
Table 60: Gemini CRC Biomarker Assay SWOT Analysis, 2013 92
Table 61: Product Profile - GenomicTree Methylated DNA Test 93
Table 62: GenomicTree Methylated DNA Test SWOT Analysis, 2013 94
Table 63: Product Profile - Measure 96
Table 64: Measure SWOT Analysis, 2013 96
Table 65: Product Profile - Metabiomics CRC Test 98
Table 66: Metabiomics CRC Test SWOT Analysis, 2013 99
Table 67: Product Profile - miR-21 Test 100
Table 68: miR-21 Test SWOT Analysis, 2013 100
Table 69: Product Profile - Oncolite-CR 101
Table 70: Oncolite-CR SWOT Analysis, 2013 102
Table 71: Product Profile - PanC-Dx 105
Table 72: PanC-Dx SWOT Analysis, 2013 105
Table 73: Company Profile - Abbott Molecular 108
Table 74: Abbott Molecular SWOT Analysis, 2013 109
Table 75: Company Profile - Alere 110
Table 76: Alere SWOT Analysis, 2013 111
Table 77: Company Profile - Beckman Coulter 112
Table 78: Beckman Coulter SWOT Analysis, 2013 113
Table 79: Company Profile - Biomarcare Technologies 114
Table 80: Biomarcare Technologies SWOT Analysis, 2013 114
Table 81: Company Profile - Companion Dx 115
Table 82: Companion Dx SWOT Analysis, 2013 116
Table 83: Company Profile - Eiken Chemical 118
Table 84: Eiken Chemical SWOT Analysis, 2013 119
Table 85: Company Profile - Epigenomics 122
Table 86: Epigenomics SWOT Analysis, 2013 123
Table 87: Company Profile - Exact Sciences 124
Table 88: Exact Sciences SWOT Analysis, 2013 128
Table 89: Company Profile - ExiQon 129
Table 90: ExiQon SWOT Analysis, 2013 130
Table 91: Company Profile - Fujirebio (Miraca Holdings) 131
Table 92: Fujirebio SWOT Analysis, 2013 132
Table 93: Company Profile - GeneNews 133
Table 94: GeneNews SWOT Analysis, 2013 134
Table 95: Company Profile - GenomicTree 135
Table 96: GenomicTree SWOT Analysis, 2013 135
Table 97: Company Profile - Immunostics 136
Table 98: Immunostics SWOT Analysis, 2013 138
Table 99: Company Profile - Kyowa Medex (Kyowa Hakko Kirin Group) 139
Table 100: Kyowa Medex SWOT Analysis, 2013 140
Table 101: Company Profile - MDx Health 141
Table 102: MDx Health SWOT Analysis, 2013 143
Table 103: Company Profile - Merck Millipore 144
Table 104: Merck Millipore SWOT Analysis, 2013 145
Table 105: Company Profile - Metabiomics 146
Table 106: Metabiomics SWOT Analysis, 2013 147
Table 107: Company Profile - Mode Diagnostics 148
Table 108: Mode Diagnostics SWOT Analysis, 2013 149
Table 109: Company Profile - Oncocyte (Bio Time) 149
Table 110: Oncocyte (Bio Time) SWOT Analysis, 2013 151
Table 111: Company Profile - Quest Diagnostics 152
Table 112: Quest Diagnostics SWOT Analysis, 2013 154
Table 113: Company Profile - R-Biopharm 156
Table 114: R-Biopharm SWOT Analysis, 2013 157
Table 115: Company Profile - Randox Laboratories 158
Table 116: Randox Laboratories SWOT Analysis, 2013 159
Table 117: Company Profile - ScheBo Biotech 160
Table 118: Schebo Biotech SWOT Analysis, 2013 161
Table 119: Company Profile - SciMarket Technologies 162
Table 120: SciMarket Technologies SWOT Analysis, 2013 163
Table 121: Company Profile - Siemens Healthcare 164
Table 122: Siemens Healthcare SWOT Analysis, 2013 165
Table 123: Company Profile - Signature Diagnostics 166
Table 124: Signature Diagnostics SWOT Analysis, 2013 167
Table 125: Company Profile - Sysmex 167
Table 126: Sysmex SWOT Analysis, 2013 169
Table 127: Company Profile - Veda Lab 170
Table 128: Veda Lab SWOT Analysis, 2013 171

1.2 List of Figures
Figure 1: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen 14
Figure 2: Fecal Occult Blood Test Lateral Flow Device Architecture 18
Figure 3: Biohit Colonview (example of immuno-FOB test) 19
Figure 4: Beckman Coulter Hemoccult-ICT (example of immuno-FOB test) 20
Figure 5: Veda Labs Easy Reader Immuno-FOB Test LFD Reader 25
Figure 6: OC-Hemodia Agglutination FOB Test (manually performed) 30
Figure 7: OC-Sensor/Diana FOB Test Sample Cartridge 31
Figure 8: OC-Sensor/Diana FOB Test Instrument 32
Figure 9: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction 33
Figure 10: Sentinel Diagnostic Sentifob Instrument 34
Figure 11: Alere CI5 NS-Plus Instrument 35
Figure 12: Orion Diagnostics Quikread FOB Test and Instrument 36
Figure 13: Basic PCR Process 43
Figure 14: MS9 PCR Response Curve 55
Figure 15: Proposed ColoGuard Patient Stool Sample Collection Kit 69
Figure 16: Exact Sciences Automated Sample Processing WorkStation 70
Figure 17: Colox Kit Contents 76
Figure 18: Measure Fecal Occult Blood Test 95
Figure 19: PanC-Dx Multiplex Detection of CRC-specific Biomarker 104

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