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Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Medical Devices Pipeline Assessment, 2017

Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, “Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Medical Devices Pipeline Assessment, 2017 provides an overview of Hepatitis Viruses Rapid Tests & POC (Point Of Care) 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 Rapid Tests & POC (Point Of Care) 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 Rapid Tests & POC (Point Of Care) 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 Rapid Tests & POC (Point Of Care) 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 Rapid Tests & POC (Point Of Care) 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


1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 7
2 Introduction 8
2.1 Hepatitis Viruses Rapid Tests & POC (Point Of Care) Overview 8
3 Products under Development 9
3.1 Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Stage of Development 9
3.2 Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Territory 10
3.3 Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Regulatory Path 11
3.4 Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Estimated Approval Date 12
4 Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products under Development by Companies 13
4.1 Hepatitis Viruses Rapid Tests & POC (Point Of Care) Companies - Pipeline Products by Stage of Development 13
4.2 Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Stage of Development 15
5 Hepatitis Viruses Rapid Tests & POC (Point Of Care) Companies and Product Overview 17
5.1 Akers Biosciences Inc Company Overview 17
5.1.1 Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 17
5.2 Alere Inc Company Overview 19
5.2.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 19
5.3 Atomo Diagnostics Pty Limited Company Overview 21
5.3.1 Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 21
5.4 Biocartis SA Company Overview 22
5.4.1 Biocartis SA Pipeline Products & Ongoing Clinical Trials Overview 22
5.5 bioLytical Laboratories Inc Company Overview 24
5.5.1 bioLytical Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 24
5.6 Biosurfit, SA Company Overview 26
5.6.1 Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 26
5.7 Biotech Consortium India Ltd Company Overview 27
5.7.1 Biotech Consortium India Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
5.8 Cepheid Company Overview 28
5.8.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 28
5.9 Chembio Diagnostic Systems Inc Company Overview 29
5.9.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 29
5.10 ChipCare Corp Company Overview 31
5.10.1 ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 31
5.11 Co-Diagnostics HBDC, Inc. Company Overview 32
5.11.1 Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
5.12 Correlia Biosystems, Inc. Company Overview 33
5.12.1 Correlia Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33
5.13 Daktari Diagnostics, Inc. Company Overview 34
5.13.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.14 Diagnostics For All Company Overview 36
5.14.1 Diagnostics For All Pipeline Products & Ongoing Clinical Trials Overview 36
5.15 Fast-track diagnostics S.a.r.l. Company Overview 38
5.15.1 Fast-track diagnostics S.a.r.l. Pipeline Products & Ongoing Clinical Trials Overview 38
5.16 GeneBio Systems Inc Company Overview 41
5.16.1 GeneBio Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 41
5.17 genedrive plc Company Overview 42
5.17.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 42
5.18 Group K Diagnostics Company Overview 44
5.18.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 44
5.19 ImmunoScience Inc Company Overview 46
5.19.1 ImmunoScience Inc Pipeline Products & Ongoing Clinical Trials Overview 46
5.20 MedMira Inc. Company Overview 48
5.20.1 MedMira Inc. Pipeline Products & Ongoing Clinical Trials Overview 48
5.21 Micronics Inc Company Overview 49
5.21.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 49
5.22 Molbio Diagnostics Pvt. Ltd. Company Overview 51
5.22.1 Molbio Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 51
5.23 NOWDiagnostics Company Overview 53
5.23.1 NOWDiagnostics Pipeline Products & Ongoing Clinical Trials Overview 53
5.24 OPKO Health Inc Company Overview 55
5.24.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 55
5.25 Sedia Biosciences Corp Company Overview 56
5.25.1 Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 56
5.26 University of California Irvine Company Overview 58
5.26.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 58
5.27 Wave 80 Biosciences Inc Company Overview 59
5.27.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 59
5.28 Xagenic Inc. Company Overview 62
5.28.1 Xagenic Inc. Pipeline Products & Ongoing Clinical Trials Overview 62
6 Hepatitis Viruses Rapid Tests & POC (Point Of Care)- Recent Developments 63
6.1 Aug 08, 2017: Akers Biosciences Announces Board Changes 63
6.2 Aug 07, 2017: Quotient Reports Results From Ongoing MosaiQ Performance Evaluation Studies and First Quarter Fiscal 2018 Financial Results 64
6.3 Aug 03, 2017: Akers Biosciences Announces Second Quarter Trading Update 66
6.4 Jul 28, 2017: Merck Announces Second-Quarter 2017 Financial Results 66
6.5 Jul 17, 2017: Governor Abbott Announces Merck IT Hub In Austin 69
6.6 May 22, 2017: Quotient Reports Continued Progress on the Commercial Scale-up of MosaiQ and Fourth Quarter and Fiscal Year 2017 Financial Results 70
6.7 May 16, 2017: NOWDiagnostics CEO Kevin Clark to Address Technology Conference 71
6.8 May 16, 2017: Akers Biosciences Announces Q1 2017 Earnings 72
6.9 May 02, 2017: Merck Announces First-Quarter 2017 Financial Results 74
6.10 Apr 24, 2017: Grifols Strengthens Position as Global Provider of Diagnostic Testing Solutions with Five-Year Extension of OraSure Technologies Agreement and a New Manufacturing Facility 76
6.11 Apr 11, 2017: Genedrive Announces Hepatitis C Assay performance data accepted for presentation at the International Liver Confrence , April 19-23 in Amsterdam 76
6.12 Apr 11, 2017: Akers Bioscience: Financial Results for the Year Ended December 31, 2016 77
6.13 Apr 11, 2017: Akers Biosciences Reports Earnings for Fiscal Year 2016 78
6.14 Apr 10, 2017: Dr. John H. Noseworthy Nominated to Stand for Election to Merck Board of Directors 82
6.15 Apr 06, 2017: Merck Receives 2017 ENERGY STAR Sustained Excellence Award from U. S. Environmental Protection Agency 83
6.16 Mar 31, 2017: City Of Austin Announces Merck Economic Development Proposal 83
6.17 Mar 30, 2017: Akers Biosciences Reports Preliminary Unaudited Earnings Highlights for Fiscal Year 2016 84
6.18 Mar 30, 2017: Genedrive: Interim Results for the six month period to 31 December 2016 85
6.19 Mar 27, 2017: Genedrive HCV Assay Submitted For CE IVD Certification 86
6.20 Mar 08, 2017: genedrive Announces Successful Clinical Results for Genedrive HCV Assay 87
6.21 Feb 09, 2017: Quotient Announces Appointment of Christopher Lindop as Chief Financial Officer 87
6.22 Feb 06, 2017: Quotient Reports Continued Progress on the Commercial Scale-up of MosaiQ and Third Quarter Fiscal 2017 Financial Results 88
6.23 Feb 02, 2017: Merck Announces Fourth-Quarter and Full-Year 2016 Financial Results 89
6.24 Jan 25, 2017: Daktari Achieves Milestone in Its Merck HCV Collaboration 91
6.25 Nov 29, 2016: genedrive: Update on CFO Appointment 92
6.26 Nov 14, 2016: Akers Biosciences Announces Q3 Earnings 92
6.27 Nov 02, 2016: Quotient Announces CFO Transition 94
6.28 Oct 31, 2016: Quotient Second Quarter Fiscal 2017 Financial Results 94
6.29 Oct 31, 2016: Quotient Reports Continued Progress on the Commercial Scale-up of MosaiQ and Second Quarter Fiscal 2017 Financial Results 95
6.30 Oct 25, 2016: Merck Announces Third-Quarter 2016 Financial Results 98
6.31 Oct 11, 2016: Genedrive Announces Preliminary Results for the year ended 30 June 2016 101
6.32 Sep 30, 2016: Correlia Bio Receives NIH SBIR Grant to Develop Diagnostic Test For Hepatitis C Infection 106
6.33 Sep 21, 2016: Genedrive Announces Appointment of Chief Financial Officer 107
7 Appendix 108
7.1 Methodology 108
7.2 About GlobalData 111
7.3 Contact Us 111
7.4 Disclaimer 111
1.1 List of Tables
Table 1: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Stage of Development 9
Table 2: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Territory 10
Table 3: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Regulatory Path 11
Table 4: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Estimated Approval Date 12
Table 5: Hepatitis Viruses Rapid Tests & POC (Point Of Care) Companies - Pipeline Products by Stage of Development 13
Table 6: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Stage of Development 15
Table 7: Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 17
Table 8: PIFA Hep B / Hep C - Product Status 17
Table 9: PIFA Hep B / Hep C - Product Description 18
Table 10: PIFA PLUSS Hepatitis B Assay - Product Status 18
Table 11: PIFA PLUSS Hepatitis B Assay - Product Description 18
Table 12: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 19
Table 13: Alere i System - HBV Assay - Product Status 19
Table 14: Alere i System - HBV Assay - Product Description 19
Table 15: Alere q Analyzer - HCV VL Assay - Product Status 20
Table 16: Alere q Analyzer - HCV VL Assay - Product Description 20
Table 17: Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 21
Table 18: AtomoRapid - Hepatitis C - Product Status 21
Table 19: AtomoRapid - Hepatitis C - Product Description 21
Table 20: Biocartis SA Pipeline Products & Ongoing Clinical Trials Overview 22
Table 21: Idylla Viral Load Assay - HBV - Product Status 22
Table 22: Idylla Viral Load Assay - HBV - Product Description 22
Table 23: Idylla Viral Load Assay - HCV - Product Status 23
Table 24: Idylla Viral Load Assay - HCV - Product Description 23
Table 25: bioLytical Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 24
Table 26: INSTI Test - Hepatitis B - Product Status 24
Table 27: INSTI Test - Hepatitis B - Product Description 24
Table 28: INSTI Test - Hepatitis C - Product Status 25
Table 29: INSTI Test - Hepatitis C - Product Description 25
Table 30: Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 26
Table 31: Spinit Device - Hepatitis C Biomarker Assay - Product Status 26
Table 32: Spinit Device - Hepatitis C Biomarker Assay - Product Description 26
Table 33: Biotech Consortium India Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
Table 34: Diagnostic Kit - Hepatitis A - Product Status 27
Table 35: Diagnostic Kit - Hepatitis A - Product Description 27
Table 36: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 28
Table 37: GeneXpert Omni - Xpert HCV Viral Load - Product Status 28
Table 38: GeneXpert Omni - Xpert HCV Viral Load - Product Description 28
Table 39: Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 29
Table 40: DPP Hepatitis C Virus Assay - Product Status 29
Table 41: DPP Hepatitis C Virus Assay - Product Description 29
Table 42: Next Generation DPP HCV Assay - Product Status 30
Table 43: Next Generation DPP HCV Assay - Product Description 30
Table 44: ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 31
Table 45: Diagnostic Assay - Hepatitis C - Product Status 31
Table 46: Diagnostic Assay - Hepatitis C - Product Description 31
Table 47: Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
Table 48: Molecular Diagnostic Kit - Hepatitis B - Product Status 32
Table 49: Molecular Diagnostic Kit - Hepatitis B - Product Description 32
Table 50: Correlia Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33
Table 51: Diagnostic Test - Hepatitis C Infection - Product Status 33
Table 52: Diagnostic Test - Hepatitis C Infection - Product Description 33
Table 53: Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 54: Aspect - HCV-cAg Test - Product Status 34
Table 55: Aspect - HCV-cAg Test - Product Description 34
Table 56: Daktari HCV Assay - Product Status 35
Table 57: Daktari HCV Assay - Product Description 35
Table 58: Diagnostics For All Pipeline Products & Ongoing Clinical Trials Overview 36
Table 59: Paper-Based Microfluidic Device - Hepatitis B - Product Status 36
Table 60: Paper-Based Microfluidic Device - Hepatitis B - Product Description 36
Table 61: Paper-Based Microfluidic Device - Hepatitis C - Product Status 37
Table 62: Paper-Based Microfluidic Device - Hepatitis C - Product Description 37
Table 63: Fast-track diagnostics S.a.r.l. Pipeline Products & Ongoing Clinical Trials Overview 38
Table 64: FTD HDV RNA Assay - Product Status 38
Table 65: FTD HDV RNA Assay - Product Description 38
Table 66: FTD Hepatitis B DNA Assay - Product Status 39
Table 67: FTD Hepatitis B DNA Assay - Product Description 39
Table 68: FTD Hepatitis C RNA Assay - Product Status 39
Table 69: FTD Hepatitis C RNA Assay - Product Description 40
Table 70: FTD Hepatitis E RNA Assay - Product Status 40
Table 71: FTD Hepatitis E RNA Assay - Product Description 40
Table 72: GeneBio Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 73: HCV Assay - Product Status 41
Table 74: HCV Assay - Product Description 41
Table 75: genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 42
Table 76: Genedrive HCV ID Kit - Product Status 42
Table 77: Genedrive HCV ID Kit - Product Description 43
Table 78: Genedrive Next-Generation HCV Test - Product Status 43
Table 79: Genedrive Next-Generation HCV Test - Product Description 43
Table 80: Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 44
Table 81: Multidiagnostic - Hepatitis A-D Virus Test - Product Status 44
Table 82: Multidiagnostic - Hepatitis A-D Virus Test - Product Description 44
Table 83: Multidiagnostic - Hepatitis Load Test - Product Status 45
Table 84: Multidiagnostic - Hepatitis Load Test - Product Description 45
Table 85: ImmunoScience Inc Pipeline Products & Ongoing Clinical Trials Overview 46
Table 86: Salivax - Hepatitis B - Product Status 46
Table 87: Salivax - Hepatitis B - Product Description 46
Table 88: Salivax - Hepatitis C - Product Status 47
Table 89: Salivax - Hepatitis C - Product Description 47
Table 90: MedMira Inc. Pipeline Products & Ongoing Clinical Trials Overview 48
Table 91: Reveal HBsAg Rapid Test - Product Status 48
Table 92: Reveal HBsAg Rapid Test - Product Description 48
Table 93: Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 49
Table 94: PanNAT - HBV Assay - Product Status 49
Table 95: PanNAT - HBV Assay - Product Description 49
Table 96: PanNAT - HCV Assay - Product Status 50
Table 97: PanNAT - HCV Assay - Product Description 50
Table 98: Molbio Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 51
Table 99: Truenat HCV Viral Load Assay - Product Status 51
Table 100: Truenat HCV Viral Load Assay - Product Description 51
Table 101: Truenat HPV Assay - Product Status 52
Table 102: Truenat HPV Assay - Product Description 52
Table 103: NOWDiagnostics Pipeline Products & Ongoing Clinical Trials Overview 53
Table 104: ADEXUSDx Hepatitis B Test - Product Status 53
Table 105: ADEXUSDx Hepatitis B Test - Product Description 53
Table 106: ADEXUSDx Hepatitis C Test - Product Status 54
Table 107: ADEXUSDx Hepatitis C Test - Product Description 54
Table 108: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 55
Table 109: Diagnostic Assay - HBV - Product Status 55
Table 110: Diagnostic Assay - HBV - Product Description 55
Table 111: Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 56
Table 112: Asanté Rapid Hepatitis C (Anti-Hepatitis C Antibody) Blood/Oral Fluid Test - Product Status 56
Table 113: Asanté Rapid Hepatitis C (Anti-Hepatitis C Antibody) Blood/Oral Fluid Test - Product Description 56
Table 114: Rapid Anti-Hepatitis B Ab Blood/Oral Fluid Test - Product Status 57
Table 115: Rapid Anti-Hepatitis B Ab Blood/Oral Fluid Test - Product Description 57
Table 116: University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 58
Table 117: One-Step Screening And Diagnostic Test - HCV Infection - Product Status 58
Table 118: One-Step Screening And Diagnostic Test - HCV Infection - Product Description 58
Table 119: Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 59
Table 120: EOSCAPE-CLEF - Product Status 59
Table 121: EOSCAPE-CLEF - Product Description 59
Table 122: EOSCAPE-HBV DNA - Product Status 60
Table 123: EOSCAPE-HBV DNA - Product Description 60
Table 124: EOSCAPE-HBV DNA PLUS - Product Status 60
Table 125: EOSCAPE-HBV DNA PLUS - Product Description 61
Table 126: EOSCAPE-HCV RNA - Product Status 61
Table 127: EOSCAPE-HCV RNA - Product Description 61
Table 128: Xagenic Inc. Pipeline Products & Ongoing Clinical Trials Overview 62
Table 129: Hepatitis C Virus Genotyping Assay - Product Status 62
Table 130: Hepatitis C Virus Genotyping Assay - Product Description 62
Table 131: Glossary 110
1.2 List of Figures
Figure 1: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Stage of Development 9
Figure 2: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Territory 10
Figure 3: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Regulatory Path 11
Figure 4: Hepatitis Viruses Rapid Tests & POC (Point Of Care) - Pipeline Products by Estimated Approval Date 12

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