in-vitro colorectal cancer screening tests - current … · reference code gdme1013fpr |...

REFERENCE CODE GDME1013FPR | PUBLICATION DATE AUGUST 2013

IN-VITRO COLORECTAL CANCER SCREENING TESTS -

CURRENT AND FUTURE PLAYERS

In-Vitro Colorectal Cancer Screening Tests – Current and Future Players 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

IN-VITRO COLORECTAL CANCER SCREENING TESTS – CURRENT AND FUTURE PLAYERS

Table of Contents

1 Table of Contents

1 Table of Contents ...................................................................................................................... 2

1.1 List of Tables ........................................................................................................................ 6

1.2 List of Figures ..................................................................................................................... 12

2 Introduction ............................................................................................................................. 13

2.1 Catalyst ............................................................................................................................... 13

2.2 Related Reports .................................................................................................................. 13

3 Competitive Assessment ......................................................................................................... 14

3.1 Overview ............................................................................................................................. 14

3.2 Fecal Occult Blood Tests .................................................................................................... 14

3.2.1 Guaiac Fecal Occult Blood Stool Tests ........................................................................... 14

3.2.2 Lateral Flow Immuno-Fecal Occult Blood Tests .............................................................. 18

3.2.3 Readers .......................................................................................................................... 25

3.2.4 Immuno-FOB Test ELISA ............................................................................................... 28

3.2.5 Immuno-FOB Agglutination Tests ................................................................................... 31

3.3 CRC DNA Screening Tests ................................................................................................. 41

3.3.1 Panel DNA Tests ............................................................................................................ 41

3.3.2 Methylated Gene Testing ................................................................................................ 51

3.4 Other Biomarker Tests ........................................................................................................ 60

3.4.1 Overview ........................................................................................................................ 60

3.4.2 Tumor M2-PK Stool Test/2-in-1 Quick Test..................................................................... 60

3.4.3 Transferrin Assays .......................................................................................................... 62



Table of Contents

4 Pipeline Products .................................................................................................................... 64

4.1 Overview ............................................................................................................................. 64

4.2 Pipeline by Phases in Development .................................................................................... 64

4.3 Pipeline Product Profiles ..................................................................................................... 66

4.3.1 BST1 CRC Assay ........................................................................................................... 66

4.3.2 Cologic ........................................................................................................................... 67

4.3.3 ColoGuard ...................................................................................................................... 69

4.3.4 Colon Cancer BEC Test.................................................................................................. 73

4.3.5 Colon MarCare Plex ....................................................................................................... 74

4.3.6 Colox .............................................................................................................................. 77

4.3.7 CRC Bacterial Signature Assay ...................................................................................... 79

4.3.8 CRC Breath Test ............................................................................................................ 80

4.3.9 Epi proColon ................................................................................................................... 83

4.3.10 ExiQon MicroRNA Test ................................................................................................... 89

4.3.11 Gemini CRC Biomarker Assay ........................................................................................ 92

4.3.12 GenomicTree Methylated DNA Test ............................................................................... 93

4.3.13 Measure Fecal Occult Blood Test ................................................................................... 95

4.3.14 Metabiomics CRC Test ................................................................................................... 98

4.3.15 MiR-21 Test .................................................................................................................. 100

4.3.16 Oncolite CR .................................................................................................................. 102

4.3.17 PanC-Dx ....................................................................................................................... 104

5 Current and Future Players ................................................................................................... 107

5.1 Overview ........................................................................................................................... 107



Table of Contents

5.2 Trends in Corporate Strategy ............................................................................................ 108

5.3 Company Profiles .............................................................................................................. 108

5.3.1 Abbott Molecular ........................................................................................................... 108

5.3.2 Alere ............................................................................................................................. 110

5.3.3 Beckman Coulter .......................................................................................................... 113

5.3.4 Biomarcare Technologies ............................................................................................. 114

5.3.5 Companion Dx .............................................................................................................. 116

5.3.6 Eiken Chemical ............................................................................................................. 117

5.3.7 Epigenomics ................................................................................................................. 120

5.3.8 Exact Sciences ............................................................................................................. 125

5.3.9 ExiQon .......................................................................................................................... 129

5.3.10 Fujirebio (Miraca Holdings) ........................................................................................... 131

5.3.11 GeneNews .................................................................................................................... 134

5.3.12 GenomicTree ................................................................................................................ 135

5.3.13 Immunostics ................................................................................................................. 137

5.3.14 Kyowa Medex ............................................................................................................... 140

5.3.15 MDx Health (was OncoMethylome) .............................................................................. 142

5.3.16 Merck Millipore ............................................................................................................. 144

5.3.17 Metabiomics ................................................................................................................. 146

5.3.18 Mode Diagnostics ......................................................................................................... 148

5.3.19 Oncocyte (Bio Time) ..................................................................................................... 150

5.3.20 Quest Diagnostics......................................................................................................... 152

5.3.21 R-Biopharm .................................................................................................................. 156



Table of Contents

5.3.22 Randox Laboratories .................................................................................................... 159

5.3.23 ScheBo Biotech ............................................................................................................ 160

5.3.24 SciMarket Technologies................................................................................................ 163

5.3.25 Siemens Healthcare ..................................................................................................... 164

5.3.26 Signature Diagnostics ................................................................................................... 167

5.3.27 Sysmex ......................................................................................................................... 168

5.3.28 Veda Lab ...................................................................................................................... 170

6 Appendix ............................................................................................................................... 173

6.1 Abbreviations .................................................................................................................... 173

6.2 Bibliography ...................................................................................................................... 176

6.3 Research Methodology ..................................................................................................... 207

6.3.1 Coverage ...................................................................................................................... 207

6.3.2 Secondary Research .................................................................................................... 208

6.4 Physicians and Specialists Included in this Study ............................................................. 209

6.5 Primary Research ............................................................................................................. 210

6.6 About the Authors ............................................................................................................. 211

6.6.1 Analysts ........................................................................................................................ 211

6.6.2 Global Head of Healthcare ............................................................................................ 212

6.7 About GlobalData .............................................................................................................. 213

6.8 Disclaimer ......................................................................................................................... 213



Table of Contents

1.1 List of Tables

Table 1: CRC Screening Test Segmentation ............................................................................................. 14

Table 2: Guaiac Fecal Occult Blood Tests Product Profile ......................................................................... 15

Table 3: Guaiac FOB Test SWOT Analysis, 2013 ..................................................................................... 17

Table 4: Immuno-FOB Tests ..................................................................................................................... 22

Table 5: Product Profile – Lateral Flow Immunochemical Fecal Occult Blood Tests ................................... 24

Table 6: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, 2013 .......................... 25

Table 7: Product Profile – Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood

Tests with Readers) .................................................................................................................... 26

Table 8: Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers)

SWOT Analysis, 2013 ................................................................................................................. 27

Table 9: Fecal Occult Blood ELISA Products ............................................................................................ 28

Table 10: Product Profile – Fecal Occult Blood ELISA ................................................................................ 29

Table 11: Immuno-FOB Test ELISA SWOT Analysis, 2013 ......................................................................... 30

Table 12: Commercially Available Immuno-FOB Agglutination Test Systems .............................................. 38

Table 13: Product Profile – Immuno-FOB Agglutination Tests ..................................................................... 38

Table 14: Immuno-FOB Agglutination Tests SWOT Analysis, 2013 ............................................................. 40

Table 15: Key Mutations Associated with CRC ........................................................................................... 42

Table 16: Key Stages of PCR Gene Test .................................................................................................... 43

Table 17: Product Profile – PreGen Plus ..................................................................................................... 45

Table 18: PreGen Plus SWOT Analysis, 2013 ............................................................................................ 46

Table 19: Product Profile – K-RAS, B-RAF, PIK3CA Array .......................................................................... 47

Table 20: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, 2013 .................................................................. 48

Table 21: Product Profile – Colonsentry ...................................................................................................... 49

Table 22: Colonsentry SWOT Analysis, 2013 .............................................................................................. 49



Table of Contents

Table 23: Product Profile – Detector C 2.0 .................................................................................................. 50

Table 24: Detector C SWOT Analysis, 2013................................................................................................ 51

Table 25: Product Profile – ColoSure .......................................................................................................... 54

Table 26: ColoSure SWOT Analysis, 2013 .................................................................................................. 54

Table 27: Product Profile – MS9 ................................................................................................................. 56

Table 28: MS9 SWOT Analysis, 2013 ......................................................................................................... 57

Table 29: Septin-9 CRC Screening Marketed Laboratory-Developed Tests ................................................. 57

Table 30: Product Profile – ColoVantage/Septin-9 ...................................................................................... 58

Table 31: ColoVantage/Septin-9 SWOT Analysis, 2013 .............................................................................. 59

Table 32: Product Profile – Tumor M2-PK Stool Test/2-in-1 Quick Test ....................................................... 61

Table 33: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, 2013 .............................................. 62

Table 34: Product Profile – Transferrin Assays ........................................................................................... 63

Table 35: Transferrin Assays SWOT Analysis, 2013 ................................................................................... 63

Table 36: CRC Screening Tests Pipeline, 2012........................................................................................... 65

Table 37: Product Profile – BST1 CRC Assay ............................................................................................. 66

Table 38: BST1 CRC Assay SWOT Analysis, 2013..................................................................................... 67

Table 39: Product Profile – Cologic ............................................................................................................. 68

Table 40: Cologic SWOT Analysis, 2013..................................................................................................... 69

Table 41: Product Profile – ColoGuard ........................................................................................................ 71

Table 42: ColoGuard SWOT Analysis, 2013 ............................................................................................... 73

Table 43: Product Profile – Colon Cancer BEC Test ................................................................................... 74

Table 44: Colon Cancer BEC Test SWOT Analysis, 2013 ........................................................................... 74

Table 45: Product Profile – Colon MarCare Plex ......................................................................................... 75

Table 46: Colon MarCare Plex SWOT Analysis, 2013 ................................................................................. 76



Table of Contents

Table 47: Product Profile – Colox................................................................................................................ 78

Table 48: Colox SWOT Analysis, 2013 ....................................................................................................... 79

Table 49: Product Profile – CRC Bacterial Signature Assay ........................................................................ 80

Table 50: CRC Bacterial Signature Assay SWOT Analysis, 2013 ................................................................ 80

Table 51: Product Profile – CRC Breath Test .............................................................................................. 82

Table 52: CRC Breath Test SWOT Analysis, 2013 ...................................................................................... 82

Table 53: Product Profile – Epi proColon .................................................................................................... 85

Table 54: Epi proColon Clinical Trials ......................................................................................................... 85

Table 55: Epi proColon SWOT Analysis, 2013 ............................................................................................ 89

Table 56: ExiQon MicroRNA Sensitivity and Specificity ............................................................................... 90

Table 57: Product Profile – ExiQon microRNA Test..................................................................................... 90

Table 58: ExiQon microRNA Test SWOT Analysis, 2013 ............................................................................ 91

Table 59: Product Profile – Gemini CRC Biomarker Assay .......................................................................... 92

Table 60: Gemini CRC Biomarker Assay SWOT Analysis, 2013 ................................................................. 93

Table 61: Product Profile – GenomicTree Methylated DNA Test ................................................................. 94

Table 62: GenomicTree Methylated DNA Test SWOT Analysis, 2013 ......................................................... 95

Table 63: Product Profile – Measure ........................................................................................................... 97

Table 64: Measure SWOT Analysis, 2013 ................................................................................................... 97

Table 65: Product Profile – Metabiomics CRC Test ..................................................................................... 99

Table 66: Metabiomics CRC Test SWOT Analysis, 2013 .......................................................................... 100

Table 67: Product Profile – miR-21 Test.................................................................................................... 101

Table 68: miR-21 Test SWOT Analysis, 2013 ........................................................................................... 101

Table 69: Product Profile – Oncolite-CR.................................................................................................... 102

Table 70: Oncolite-CR SWOT Analysis, 2013 ........................................................................................... 103



Table of Contents

Table 71: Product Profile – PanC-Dx ........................................................................................................ 106

Table 72: PanC-Dx SWOT Analysis, 2013 ................................................................................................ 106

Table 73: Company Profile – Abbott Molecular ......................................................................................... 109

Table 74: Abbott Molecular SWOT Analysis, 2013 .................................................................................... 110

Table 75: Company Profile – Alere ........................................................................................................... 111

Table 76: Alere SWOT Analysis, 2013 ...................................................................................................... 112

Table 77: Company Profile – Beckman Coulter ......................................................................................... 113

Table 78: Beckman Coulter SWOT Analysis, 2013 ................................................................................... 114

Table 79: Company Profile – Biomarcare Technologies ............................................................................ 115

Table 80: Biomarcare Technologies SWOT Analysis, 2013 ....................................................................... 115

Table 81: Company Profile – Companion Dx............................................................................................. 116

Table 82: Companion Dx SWOT Analysis, 2013 ....................................................................................... 117

Table 83: Company Profile – Eiken Chemical ........................................................................................... 119

Table 84: Eiken Chemical SWOT Analysis, 2013 ...................................................................................... 120

Table 85: Company Profile – Epigenomics ................................................................................................ 123

Table 86: Epigenomics SWOT Analysis, 2013 .......................................................................................... 124

Table 87: Company Profile – Exact Sciences ............................................................................................ 125

Table 88: Exact Sciences SWOT Analysis, 2013 ...................................................................................... 129

Table 89: Company Profile – ExiQon ........................................................................................................ 130

Table 90: ExiQon SWOT Analysis, 2013 ................................................................................................... 131

Table 91: Company Profile – Fujirebio (Miraca Holdings) .......................................................................... 132

Table 92: Fujirebio SWOT Analysis, 2013 ................................................................................................. 133

Table 93: Company Profile – GeneNews .................................................................................................. 134

Table 94: GeneNews SWOT Analysis, 2013 ............................................................................................. 135



Table of Contents

Table 95: Company Profile – GenomicTree .............................................................................................. 136

Table 96: GenomicTree SWOT Analysis, 2013 ......................................................................................... 136

Table 97: Company Profile – Immunostics ................................................................................................ 137

Table 98: Immunostics SWOT Analysis, 2013 ........................................................................................... 139

Table 99: Company Profile – Kyowa Medex (Kyowa Hakko Kirin Group) ................................................... 140

Table 100: Kyowa Medex SWOT Analysis, 2013 ........................................................................................ 141

Table 101: Company Profile – MDx Health ................................................................................................. 142

Table 102: MDx Health SWOT Analysis, 2013 ............................................................................................ 144

Table 103: Company Profile – Merck Millipore ............................................................................................ 145

Table 104: Merck Millipore SWOT Analysis, 2013 ....................................................................................... 146

Table 105: Company Profile – Metabiomics ................................................................................................ 147

Table 106: Metabiomics SWOT Analysis, 2013 ........................................................................................... 148

Table 107: Company Profile – Mode Diagnostics ........................................................................................ 149

Table 108: Mode Diagnostics SWOT Analysis, 2013................................................................................... 150

Table 109: Company Profile – Oncocyte (Bio Time) .................................................................................... 150

Table 110: Oncocyte (Bio Time) SWOT Analysis, 2013 .............................................................................. 152

Table 111: Company Profile – Quest Diagnostics ....................................................................................... 153

Table 112: Quest Diagnostics SWOT Analysis, 2013 .................................................................................. 155

Table 113: Company Profile – R-Biopharm ................................................................................................. 157

Table 114: R-Biopharm SWOT Analysis, 2013 ............................................................................................ 158

Table 115: Company Profile – Randox Laboratories ................................................................................... 159

Table 116: Randox Laboratories SWOT Analysis, 2013 .............................................................................. 160

Table 117: Company Profile – ScheBo Biotech ........................................................................................... 161

Table 118: Schebo Biotech SWOT Analysis, 2013 ...................................................................................... 162



Table of Contents

Table 119: Company Profile – SciMarket Technologies .............................................................................. 163

Table 120: SciMarket Technologies SWOT Analysis, 2013 ......................................................................... 164

Table 121: Company Profile – Siemens Healthcare .................................................................................... 165

Table 122: Siemens Healthcare SWOT Analysis, 2013 ............................................................................... 166

Table 123: Company Profile – Signature Diagnostics .................................................................................. 167

Table 124: Signature Diagnostics SWOT Analysis, 2013 ............................................................................ 168

Table 125: Company Profile – Sysmex ....................................................................................................... 168

Table 126: Sysmex SWOT Analysis, 2013 .................................................................................................. 170

Table 127: Company Profile – Veda Lab ..................................................................................................... 171

Table 128: Veda Lab SWOT Analysis, 2013 ............................................................................................... 172



Table of Contents

1.2 List of Figures

Figure 1: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen ................................ 15

Figure 2: Fecal Occult Blood Test Lateral Flow Device Architecture ........................................................... 19

Figure 3: Biohit Colonview (example of immuno-FOB test) ......................................................................... 20

Figure 4: Beckman Coulter Hemoccult-ICT (example of immuno-FOB test) ................................................ 21

Figure 5: Veda Labs Easy Reader Immuno-FOB Test LFD Reader ............................................................ 26

Figure 6: OC-Hemodia Agglutination FOB Test (manually performed) ........................................................ 31

Figure 7: OC-Sensor/Diana FOB Test Sample Cartridge ............................................................................ 32

Figure 8: OC-Sensor/Diana FOB Test Instrument ...................................................................................... 33

Figure 9: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction .............................................. 34

Figure 10: Sentinel Diagnostic Sentifob Instrument ...................................................................................... 35

Figure 11: Alere CI5 NS-Plus Instrument...................................................................................................... 36

Figure 12: Orion Diagnostics Quikread FOB Test and Instrument ................................................................. 37

Figure 13: Basic PCR Process ..................................................................................................................... 44

Figure 14: MS9 PCR Response Curve ......................................................................................................... 56

Figure 15: Proposed ColoGuard Patient Stool Sample Collection Kit ............................................................ 70

Figure 16: Exact Sciences Automated Sample Processing WorkStation ....................................................... 71

Figure 17: Colox Kit Contents ...................................................................................................................... 77

Figure 18: Measure Fecal Occult Blood Test ................................................................................................ 96

Figure 19: PanC-Dx Multiplex Detection of CRC-specific Biomarker ........................................................... 105



Introduction

2 Introduction

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. This report focuses on the in-vitro CRC screening test markets in

the US and Europe (France, Germany, Italy, Spain, and the UK), Japan and future markets in

China, India and Brazil, and identifies unmet needs in the market, physician attitudes towards

current modalities in in-vitro CRC screening, and the future of CRC screening in the face of rapid

technological advancement.

2.1 Catalyst

Colorectal cancer screening can be carried out using a number of different methods which are

either invasive or non-invasive. Typical approaches include endoscopic examination of the bowel

or analysis of fecal samples for evidence of disease. Endoscopic procedures pose challenges, in

terms of patient access, cost and risk. Fecal sample analysis poses challenges in patient

compliance, disease sensitivity and disease specificity. New in-vitro tests promise improved

sensitivity and specificity, while at the same time improving patient compliance. Two new CRC

screening tests from Exact Sciences and Epigenomics are expected to receive FDA Premarket

Approval in late 2013 or early 2014, and these tests may dramatically change the in-vitro CRC

screening test landscape.



Appendix

6.7 About GlobalData

GlobalData is a leading global provider of business intelligence in the Healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in medical device research, disease analysis, and clinical research and development. Our

integrated business intelligence solutions include a range of interactive online databases, analytical

tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, Boston, London, India and Singapore.

6.8 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior

permission of the publisher, GlobalData.

in-vitro colorectal cancer screening tests - current … · reference code gdme1013fpr |...

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