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Hepatitis Viruses - Pipeline Review, 2015

  • October 2015
  • -
  • GlobalData
  • -
  • 228 pages

Hepatitis Viruses - Pipeline Review, 2015

Summary

GlobalData's Medical Devices sector report, “Hepatitis Viruses - Pipeline Review, 2015" provides an overview of Hepatitis Viruses diagnostic tests currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Hepatitis Viruses diagnostic tests pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Hepatitis Viruses diagnostic tests under development
- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
- The report reviews the major players involved in the development of Hepatitis Viruses diagnostic tests and list all their pipeline projects
- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
- The report provides key clinical trial data of ongoing trials specific to pipeline products
- Recent developments in the segment / industry

Reasons to buy

The report enables you to -
- Formulate significant competitor information, analysis, and insights to improve R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of Hepatitis Viruses diagnostic tests under development
- Develop market-entry and market expansion strategies
- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
- In-depth analysis of the product’s current stage of development, territory and estimated launch date

Table Of Contents

Hepatitis Viruses - Pipeline Review, 2015
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 12
2 Introduction 13
2.1 Hepatitis Viruses Overview 13
3 Products under Development 14
3.1 Hepatitis Viruses - Pipeline Products by Stage of Development 14
3.2 Hepatitis Viruses - Pipeline Products by Territory 15
3.3 Hepatitis Viruses - Pipeline Products by Regulatory Path 16
3.4 Hepatitis Viruses - Pipeline Products by Estimated Approval Date 17
3.5 Hepatitis Viruses - Ongoing Clinical Trials 18
4 Hepatitis Viruses - Pipeline Products under Development by Companies 19
4.1 Hepatitis Viruses Companies - Pipeline Products by Stage of Development 19
4.2 Hepatitis Viruses - Pipeline Products by Stage of Development 22
5 Hepatitis Viruses Companies and Product Overview 27
5.1 Abbott Diagnostics Company Overview 27
5.1.1 Abbott Diagnostics Pipeline Products and Ongoing Clinical Trials Overview 27
5.2 Access Bio, Inc. Company Overview 43
5.2.1 Access Bio, Inc. Pipeline Products and Ongoing Clinical Trials Overview 43
5.3 Alderon Biosciences, Inc. Company Overview 44
5.3.1 Alderon Biosciences, Inc. Pipeline Products and Ongoing Clinical Trials Overview 44
5.4 Alere Inc. Company Overview 45
5.4.1 Alere Inc. Pipeline Products and Ongoing Clinical Trials Overview 45
5.5 AXO Science S.A.S. Company Overview 47
5.5.1 AXO Science S.A.S. Pipeline Products and Ongoing Clinical Trials Overview 47
5.6 Beckman Coulter, Inc. Company Overview 48
5.6.1 Beckman Coulter, Inc. Pipeline Products and Ongoing Clinical Trials Overview 48
5.7 Biokit, S.A. Company Overview 51
5.7.1 Biokit, S.A. Pipeline Products and Ongoing Clinical Trials Overview 51
5.8 Biomagnetics Diagnostics Corporation (Inactive) Company Overview 55
5.8.1 Biomagnetics Diagnostics Corporation (Inactive) Pipeline Products and Ongoing Clinical Trials Overview 55
5.9 Bio-Rad Laboratories, Inc. Company Overview 56
5.9.1 Bio-Rad Laboratories, Inc. Pipeline Products and Ongoing Clinical Trials Overview 56
5.10 CeMines, Inc. Company Overview 59
5.10.1 CeMines, Inc. Pipeline Products and Ongoing Clinical Trials Overview 59
5.11 Cepheid Company Overview 60
5.11.1 Cepheid Pipeline Products and Ongoing Clinical Trials Overview 60
5.12 China Medical Technologies, Inc. Company Overview 64
5.12.1 China Medical Technologies, Inc. Pipeline Products and Ongoing Clinical Trials Overview 64
5.13 Co-Diagnostics HBDC, Inc. Company Overview 66
5.13.1 Co-Diagnostics HBDC, Inc. Pipeline Products and Ongoing Clinical Trials Overview 66
5.14 Corgenix Medical Corporation Company Overview 67
5.14.1 Corgenix Medical Corporation Pipeline Products and Ongoing Clinical Trials Overview 67
5.15 Da An Gene Co., Ltd. Company Overview 69
5.15.1 Da An Gene Co., Ltd. Pipeline Products and Ongoing Clinical Trials Overview 69
5.16 Diagnostics for the Real World (Europe) Ltd. Company Overview 74
5.16.1 Diagnostics for the Real World (Europe) Ltd. Pipeline Products and Ongoing Clinical Trials Overview 74
5.17 DiaSorin S.p.A Company Overview 75
5.17.1 DiaSorin S.p.A Pipeline Products and Ongoing Clinical Trials Overview 75
5.18 D-Kimia, LLC. Company Overview 78
5.18.1 D-Kimia, LLC. Pipeline Products and Ongoing Clinical Trials Overview 78
5.19 Ecoli s.r.o. Company Overview 79
5.19.1 Ecoli s.r.o. Pipeline Products and Ongoing Clinical Trials Overview 79
5.20 Enzo Biochem, Inc. Company Overview 98
5.20.1 Enzo Biochem, Inc. Pipeline Products and Ongoing Clinical Trials Overview 98
5.21 Epistem Holdings Plc Company Overview 100
5.21.1 Epistem Holdings Plc Pipeline Products and Ongoing Clinical Trials Overview 100
5.22 Fast-track diagnostics S.a.r.l. Company Overview 102
5.22.1 Fast-track diagnostics S.a.r.l. Pipeline Products and Ongoing Clinical Trials Overview 102
5.23 Genera Biosystems Limited Company Overview 109
5.23.1 Genera Biosystems Limited Pipeline Products and Ongoing Clinical Trials Overview 109
5.24 General Biologicals Corporation Company Overview 111
5.24.1 General Biologicals Corporation Pipeline Products and Ongoing Clinical Trials Overview 111
5.25 GenMark Diagnostics, Inc. Company Overview 114
5.25.1 GenMark Diagnostics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 114
5.26 Hologic, Inc. Company Overview 116
5.26.1 Hologic, Inc. Pipeline Products and Ongoing Clinical Trials Overview 116
5.27 InstantLabs Medical Diagnostics Corporation Company Overview 121
5.27.1 InstantLabs Medical Diagnostics Corporation Pipeline Products and Ongoing Clinical Trials Overview 121
5.28 Institut National de la Sante et de la Recherche Medicale Company Overview 122
5.28.1 Institut National de la Sante et de la Recherche Medicale Pipeline Products and Ongoing Clinical Trials Overview 122
5.29 MedMira Inc. Company Overview 123
5.29.1 MedMira Inc. Pipeline Products and Ongoing Clinical Trials Overview 123
5.30 Mindray Medical International Limited Company Overview 130
5.30.1 Mindray Medical International Limited Pipeline Products and Ongoing Clinical Trials Overview 130
5.31 MND Diagnostic LTD Company Overview 137
5.31.1 MND Diagnostic LTD Pipeline Products and Ongoing Clinical Trials Overview 137
5.32 NanoDiagX Company Overview 139
5.32.1 NanoDiagX Pipeline Products and Ongoing Clinical Trials Overview 139
5.33 OPKO Health, Inc. Company Overview 141
5.33.1 OPKO Health, Inc. Pipeline Products and Ongoing Clinical Trials Overview 141
5.34 Pathogenica, Inc. Company Overview 144
5.34.1 Pathogenica, Inc. Pipeline Products and Ongoing Clinical Trials Overview 144
5.35 Polartechnics Limited Company Overview 145
5.35.1 Polartechnics Limited Pipeline Products and Ongoing Clinical Trials Overview 145
5.36 ProteinLogic Ltd Company Overview 146
5.36.1 ProteinLogic Ltd Pipeline Products and Ongoing Clinical Trials Overview 146
5.37 Qiagen N.V. Company Overview 147
5.37.1 Qiagen N.V. Pipeline Products and Ongoing Clinical Trials Overview 147
5.38 Quotient Limited Company Overview 150
5.38.1 Quotient Limited Pipeline Products and Ongoing Clinical Trials Overview 150
5.39 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Company Overview 152
5.39.1 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Pipeline Products and Ongoing Clinical Trials Overview 152
5.40 Roche Diagnostics GmbH Company Overview 153
5.40.1 Roche Diagnostics GmbH Pipeline Products and Ongoing Clinical Trials Overview 153
5.41 Roche Diagnostics International Ltd. Company Overview 155
5.41.1 Roche Diagnostics International Ltd. Pipeline Products and Ongoing Clinical Trials Overview 155
5.42 Sedia Biosciences Corporation Company Overview 168
5.42.1 Sedia Biosciences Corporation Pipeline Products and Ongoing Clinical Trials Overview 168
5.43 Siemens Healthcare Diagnostics Inc. Company Overview 169
5.43.1 Siemens Healthcare Diagnostics Inc. Pipeline Products and Ongoing Clinical Trials Overview 169
5.44 Stanford University Company Overview 179
5.44.1 Stanford University Pipeline Products and Ongoing Clinical Trials Overview 179
5.45 Syamala Srinivasa Life Sciences Pvt. Ltd Company Overview 181
5.45.1 Syamala Srinivasa Life Sciences Pvt. Ltd Pipeline Products and Ongoing Clinical Trials Overview 181
5.46 The Johns Hopkins University Company Overview 183
5.46.1 The Johns Hopkins University Pipeline Products and Ongoing Clinical Trials Overview 183
5.47 TrovaGene, Inc. Company Overview 184
5.47.1 TrovaGene, Inc. Pipeline Products and Ongoing Clinical Trials Overview 184
5.48 University of California, Irvine Company Overview 186
5.48.1 University of California, Irvine Pipeline Products and Ongoing Clinical Trials Overview 186
5.49 University of Texas Medical Branch at Galveston Company Overview 187
5.49.1 University of Texas Medical Branch at Galveston Pipeline Products and Ongoing Clinical Trials Overview 187
5.50 University of Warwick Company Overview 188
5.50.1 University of Warwick Pipeline Products and Ongoing Clinical Trials Overview 188
5.51 Vela Diagnostics Company Overview 189
5.51.1 Vela Diagnostics Pipeline Products and Ongoing Clinical Trials Overview 189
5.52 Xagenic Inc. Company Overview 192
5.52.1 Xagenic Inc. Pipeline Products and Ongoing Clinical Trials Overview 192
5.53 Xiamen Zeesan Biotech Co.,Ltd Company Overview 193
5.53.1 Xiamen Zeesan Biotech Co.,Ltd Pipeline Products and Ongoing Clinical Trials Overview 193
6 Hepatitis Viruses- Recent Developments 194
7 Appendix 225
7.1 Methodology 225
7.2 About GlobalData 227
7.3 Contact Us 228
7.4 Disclaimer 228

1.1 List of Tables
Table 1: Hepatitis Viruses - Pipeline Products by Stage of Development 14
Table 2: Hepatitis Viruses - Pipeline Products by Territory 15
Table 3: Hepatitis Viruses - Pipeline Products by Regulatory Path 16
Table 4: Hepatitis Viruses - Pipeline Products by Estimated Approval Date 17
Table 5: Hepatitis Viruses - Ongoing Clinical Trials 18
Table 6: Hepatitis Viruses Companies - Pipeline Products by Stage of Development 19
Table 7: Hepatitis Viruses - Pipeline Products by Stage of Development 22
Table 8: Abbott Diagnostics Pipeline Products and Ongoing Clinical Trials Overview 27
Table 9: ARCHITECT c16000 System - Anti-HAV IgG Assay - Product Status 28
Table 10: ARCHITECT c16000 System - Anti-HAV IgG Assay - Product Description 28
Table 11: ARCHITECT c16000 System - HbSAg Assay - Product Status 29
Table 12: ARCHITECT c16000 System - HbSAg Assay - Product Description 29
Table 13: ARCHITECT c4000 Integrated System - Anti-HAV IgG Assay - Product Status 30
Table 14: ARCHITECT c4000 Integrated System - Anti-HAV IgG Assay - Product Description 30
Table 15: ARCHITECT c4000 System - HbSAg Assay - Product Status 31
Table 16: ARCHITECT c4000 System - HbSAg Assay - Product Description 31
Table 17: ARCHITECT c8000 Integrated System - Anti-HAV IgG Assay - Product Status 32
Table 18: ARCHITECT c8000 Integrated System - Anti-HAV IgG Assay - Product Description 32
Table 19: ARCHITECT c8000 System - HbSAg Assay - Product Status 33
Table 20: ARCHITECT c8000 System - HbSAg Assay - Product Description 33
Table 21: ARCHITECT ci16200 Integrated System - Anti-HAV IgG Assay - Product Status 34
Table 22: ARCHITECT ci16200 Integrated System - Anti-HAV IgG Assay - Product Description 34
Table 23: ARCHITECT ci16200 Integrated System - HbSAg Assay - Product Status 35
Table 24: ARCHITECT ci16200 Integrated System - HbSAg Assay - Product Description 35
Table 25: ARCHITECT ci4100 Integrated System - Anti-HAV IgG Assay - Product Status 36
Table 26: ARCHITECT ci4100 Integrated System - Anti-HAV IgG Assay - Product Description 36
Table 27: ARCHITECT ci4100 Integrated System - HbSAg Assay - Product Status 37
Table 28: ARCHITECT ci4100 Integrated System - HbSAg Assay - Product Description 37
Table 29: ARCHITECT ci8200 Integrated System - Anti-HAV IgG Assay - Product Status 38
Table 30: ARCHITECT ci8200 Integrated System - Anti-HAV IgG Assay - Product Description 38
Table 31: ARCHITECT ci8200 Integrated System - HbSAg Assay - Product Status 39
Table 32: ARCHITECT ci8200 Integrated System - HbSAg Assay - Product Description 39
Table 33: ARCHITECT i1000SR Integrated System - Anti-HAV IgG Assay - Product Status 40
Table 34: ARCHITECT i1000SR Integrated System - Anti-HAV IgG Assay - Product Description 40
Table 35: ARCHITECT i2000SR System - Anti-HAV IgG Assay - Product Status 41
Table 36: ARCHITECT i2000SR System - Anti-HAV IgG Assay - Product Description 41
Table 37: ARCHITECT i4000SR System - Anti-HAV IgG Assay - Product Status 42
Table 38: ARCHITECT i4000SR System - Anti-HAV IgG Assay - Product Description 42
Table 39: Access Bio, Inc. Pipeline Products and Ongoing Clinical Trials Overview 43
Table 40: RosGENE For Hepatitis - Product Status 43
Table 41: RosGENE For Hepatitis - Product Description 43
Table 42: Alderon Biosciences, Inc. Pipeline Products and Ongoing Clinical Trials Overview 44
Table 43: eSystem - Qualitative HCV RNA Assay - Product Status 44
Table 44: eSystem - Qualitative HCV RNA Assay - Product Description 44
Table 45: Alere Inc. Pipeline Products and Ongoing Clinical Trials Overview 45
Table 46: Diagnostic Test - Hepatitis B/C - Product Status 46
Table 47: Diagnostic Test - Hepatitis B/C - Product Description 46
Table 48: AXO Science S.A.S. Pipeline Products and Ongoing Clinical Trials Overview 47
Table 49: Multiplexed Detection - Anti-HCV Antibodies - Product Status 47
Table 50: Multiplexed Detection - Anti-HCV Antibodies - Product Description 47
Table 51: Beckman Coulter, Inc. Pipeline Products and Ongoing Clinical Trials Overview 48
Table 52: UniCel DxN - HCV Viral Load Test - Product Status 48
Table 53: UniCel DxN - HCV Viral Load Test - Product Description 48
Table 54: VERIS HBV Assay - Product Status 49
Table 55: VERIS HBV Assay - Product Description 49
Table 56: VERIS HCV Assay - Product Status 50
Table 57: VERIS HCV Assay - Product Description 50
Table 58: Biokit, S.A. Pipeline Products and Ongoing Clinical Trials Overview 51
Table 59: BIO-FLASH anti-HBe Assay - Product Status 52
Table 60: BIO-FLASH anti-HBe Assay - Product Description 52
Table 61: BIO-FLASH HAV Assay - Product Status 53
Table 62: BIO-FLASH HAV Assay - Product Description 53
Table 63: BIO-FLASH HBe Ag Assay - Product Status 54
Table 64: BIO-FLASH HBe Ag Assay - Product Description 54
Table 65: Biomagnetics Diagnostics Corporation (Inactive) Pipeline Products and Ongoing Clinical Trials Overview 55
Table 66: Diagnostic Test - Hepatitis B - Product Status 55
Table 67: Diagnostic Test - Hepatitis B - Product Description 55
Table 68: Bio-Rad Laboratories, Inc. Pipeline Products and Ongoing Clinical Trials Overview 56
Table 69: BioPlex 2200 - Hepatitis Test - Product Status 57
Table 70: BioPlex 2200 - Hepatitis Test - Product Description 57
Table 71: BioPlex 2200 - HIV/Hep Screening - Product Status 58
Table 72: BioPlex 2200 - HIV/Hep Screening - Product Description 58
Table 73: CeMines, Inc. Pipeline Products and Ongoing Clinical Trials Overview 59
Table 74: Diagnostic Test - Hepatitis C - Product Status 59
Table 75: Diagnostic Test - Hepatitis C - Product Description 59
Table 76: Cepheid Pipeline Products and Ongoing Clinical Trials Overview 60
Table 77: GeneXpert Omni - Xpert HCV Viral Load - Product Status 61
Table 78: GeneXpert Omni - Xpert HCV Viral Load - Product Description 61
Table 79: Xpert HBV Viral Load Assay - Product Status 62
Table 80: Xpert HBV Viral Load Assay - Product Description 62
Table 81: Xpert HCV Quant Assay - Product Status 63
Table 82: Xpert HCV Quant Assay - Product Description 63
Table 83: China Medical Technologies, Inc. Pipeline Products and Ongoing Clinical Trials Overview 64
Table 84: Diagnostic Assay - HCVA - Product Status 65
Table 85: Diagnostic Assay - HCVA - Product Description 65
Table 86: Co-Diagnostics HBDC, Inc. Pipeline Products and Ongoing Clinical Trials Overview 66
Table 87: HCV RNA Real-time PCR Kit - Product Status 66
Table 88: HCV RNA Real-time PCR Kit - Product Description 66
Table 89: Corgenix Medical Corporation Pipeline Products and Ongoing Clinical Trials Overview 67
Table 90: Diagnostic Test - Hepatitis C - Product Status 68
Table 91: Diagnostic Test - Hepatitis C - Product Description 68
Table 92: Da An Gene Co., Ltd. Pipeline Products and Ongoing Clinical Trials Overview 69
Table 93: Real Time PCR Kit - HAV - Product Status 70
Table 94: Real Time PCR Kit - HAV - Product Description 70
Table 95: Real Time PCR Kit - HEV - Product Status 71
Table 96: Real Time PCR Kit - HEV - Product Description 71
Table 97: Real Time PCR Kit - HGV - Product Status 72
Table 98: Real Time PCR Kit - HGV - Product Description 72
Table 99: Real Time PCR Kit - HGV-LC - Product Status 73
Table 100: Real Time PCR Kit - HGV-LC - Product Description 73
Table 101: Diagnostics for the Real World (Europe) Ltd. Pipeline Products and Ongoing Clinical Trials Overview 74
Table 102: SAS - Hepatitis-C Assay - Product Status 74
Table 103: SAS - Hepatitis-C Assay - Product Description 74
Table 104: DiaSorin S.p.A Pipeline Products and Ongoing Clinical Trials Overview 75
Table 105: Diagnostic Assay - HBsAg High Throughput - Product Status 76
Table 106: Diagnostic Assay - HBsAg High Throughput - Product Description 76
Table 107: LIAISON XL - Hepatitis B Assay - Product Status 77
Table 108: LIAISON XL - Hepatitis B Assay - Product Description 77
Table 109: D-Kimia, LLC. Pipeline Products and Ongoing Clinical Trials Overview 78
Table 110: HCV Nanogold Assay - Product Status 78
Table 111: HCV Nanogold Assay - Product Description 78
Table 112: Ecoli s.r.o. Pipeline Products and Ongoing Clinical Trials Overview 79
Table 113: AmpliSens HBV-Eph PCR Kit - Product Status 80
Table 114: AmpliSens HBV-Eph PCR Kit - Product Description 80
Table 115: AmpliSens HBV-FEP PCR Kit - Product Status 81
Table 116: AmpliSens HBV-FEP PCR Kit - Product Description 81
Table 117: AmpliSens HBV-FRT PCR Kit - Product Status 82
Table 118: AmpliSens HBV-FRT PCR Kit - Product Description 82
Table 119: AmpliSens HBV-Monitor-FRT PCR Kit - Product Status 83
Table 120: AmpliSens HBV-Monitor-FRT PCR Kit - Product Description 83
Table 121: AmpliSens HBV/HDV-FRT PCR Kit - Product Status 84
Table 122: AmpliSens HBV/HDV-FRT PCR Kit - Product Description 84
Table 123: AmpliSens HCV-1/2/3-FEP PCR Kit - Product Status 85
Table 124: AmpliSens HCV-1/2/3-FEP PCR Kit - Product Description 85
Table 125: AmpliSens HCV-1/2/3-FRT PCR Kit - Product Status 86
Table 126: AmpliSens HCV-1/2/3-FRT PCR Kit - Product Description 86
Table 127: AmpliSens HCV-Eph PCR Kit - Product Status 87

1.2 List of Figures
Figure 1: Hepatitis Viruses - Pipeline Products by Stage of Development 14
Figure 2: Hepatitis Viruses - Pipeline Products by Territory 15
Figure 3: Hepatitis Viruses - Pipeline Products by Regulatory Path 16
Figure 4: Hepatitis Viruses - Pipeline Products by Estimated Approval Date 17
Figure 5: Hepatitis Viruses - Ongoing Clinical Trials 18

Companies Mentioned
Abbott Diagnostics
Access Bio, Inc.
Alderon Biosciences, Inc.
Alere Inc.
AXO Science S.A.S.
Beckman Coulter, Inc.
Biokit, S.A.
Bio-Rad Laboratories, Inc.
CeMines, Inc.
Cepheid
China Medical Technologies, Inc.
Co-Diagnostics HBDC, Inc.
Corgenix Medical Cor

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