Published : Sep-2017
No. of Pages : 111
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
