Hepatitis Viruses Rapid Tests & Point of Care (POC) - Medical Devices Pipeline Assessment, 2019

2019-11-14
Price :
Published : Nov-2019
No. of Pages : 130
Table of Contents
1.1 List of Tables 5
1.2 List of Figures 7
2 Introduction 9
2.1 Hepatitis Viruses Rapid Tests & Point of Care (POC) Overview 9
Hepatitis Viruses Rapid Tests & Point of Care (POC) are the rapid diagnostic tests used to detect the hepatitis viruses or the virus antigens antibodies and generate results immediately in a limited resource setting. 9
3 Products under Development 10
3.1 Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 10
3.2 Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 11
3.3 Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 12
3.4 Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 13
3.5 Hepatitis Viruses Rapid Tests & Point of Care (POC) - Ongoing Clinical Trials 14
4 Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products under Development by Companies 15
4.1 Hepatitis Viruses Rapid Tests & Point of Care (POC) Companies - Pipeline Products by Stage of Development 15
4.2 Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 17
5 Hepatitis Viruses Rapid Tests & Point of Care (POC) Companies and Product Overview 19
5.1 Abbott Diagnostics Company Overview 19
5.1.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 19
5.2 Access Bio Inc Company Overview 20
5.2.1 Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 20
5.3 Akers Biosciences Inc Company Overview 21
5.3.1 Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 21
5.4 Alere Inc Company Overview 22
5.4.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 22
5.5 Atomo Diagnostics Pty Ltd Company Overview 23
5.5.1 Atomo Diagnostics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
5.6 Biocartis Group NV Company Overview 24
5.6.1 Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 24
5.7 bioLytical Laboratories Inc Company Overview 26
5.7.1 bioLytical Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 26
5.8 Biosurfit, SA Company Overview 27
5.8.1 Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 27
5.9 Biotech Consortium India Ltd Company Overview 28
5.9.1 Biotech Consortium India Ltd Pipeline Products & Ongoing Clinical Trials Overview 28
5.10 Biotech Resources Pty Ltd Company Overview 29
5.10.1 Biotech Resources Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 29
5.11 Blink AG Company Overview 30
5.11.1 Blink AG Pipeline Products & Ongoing Clinical Trials Overview 30
5.12 Cepheid Company Overview 31
5.12.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 31
5.13 Chembio Diagnostic Systems Inc Company Overview 32
5.13.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 32
5.14 ChipCare Corp Company Overview 34
5.14.1 ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 34
5.15 Co-Diagnostics HBDC, Inc. Company Overview 35
5.15.1 Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35
5.16 Co-Diagnostics Inc Company Overview 36
5.16.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 36
5.17 Correlia Biosystems, Inc. Company Overview 37
5.17.1 Correlia Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37
5.18 CrossLife Technologies Inc Company Overview 38
5.18.1 CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 38
5.19 Daktari Diagnostics, Inc. Company Overview 39
5.19.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39
5.20 DCN Diagnostics Company Overview 40
5.20.1 DCN Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 40
5.21 Diagnostics For All Inc Company Overview 41
5.21.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 41
5.22 Diagnostics for the Real World Limited Company Overview 43
5.22.1 Diagnostics for the Real World Limited Pipeline Products & Ongoing Clinical Trials Overview 43
5.23 DxDiscovery, Inc. Company Overview 45
5.23.1 DxDiscovery, Inc. Pipeline Products & Ongoing Clinical Trials Overview 45
5.24 Fast Track Diagnostics Ltd. Company Overview 46
5.24.1 Fast Track Diagnostics Ltd. Pipeline Products & Ongoing Clinical Trials Overview 46
5.25 genedrive plc Company Overview 47
5.25.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 47
5.26 Group K Diagnostics Company Overview 50
5.26.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 50
5.27 HLL Lifecare Ltd Company Overview 52
5.27.1 HLL Lifecare Ltd Pipeline Products & Ongoing Clinical Trials Overview 52
5.28 ImmunoScience Inc Company Overview 53
5.28.1 ImmunoScience Inc Pipeline Products & Ongoing Clinical Trials Overview 53
5.29 MedMira Inc Company Overview 55
5.29.1 MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 55
5.30 Micronics Inc Company Overview 56
5.30.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 56
5.31 Mologic Ltd Company Overview 58
5.31.1 Mologic Ltd Pipeline Products & Ongoing Clinical Trials Overview 58
5.32 NanoComposix Inc Company Overview 59
5.32.1 NanoComposix Inc Pipeline Products & Ongoing Clinical Trials Overview 59
5.33 NanoRepro AG Company Overview 60
5.33.1 NanoRepro AG Pipeline Products & Ongoing Clinical Trials Overview 60
5.34 NOWDiagnostics Inc Company Overview 61
5.34.1 NOWDiagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 61
5.35 Quidel Corp Company Overview 63
5.35.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 63
5.36 Sedia Biosciences Corp Company Overview 64
5.36.1 Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 64
5.37 SLS Cell Cure Technologies Pty Ltd Company Overview 67
5.37.1 SLS Cell Cure Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 67
5.38 University of California Irvine Company Overview 69
5.38.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 69
5.39 Wave 80 Biosciences Inc Company Overview 70
5.39.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 70
5.40 Xagenic Inc Company Overview 73
5.40.1 Xagenic Inc Pipeline Products & Ongoing Clinical Trials Overview 73
6 Hepatitis Viruses Rapid Tests & Point of Care (POC) - Recent Developments 74
6.1 Nov 04, 2019: Quotient reports second quarter fiscal 2020 financial results 74
6.2 Oct 29, 2019: Merck announces third-quarter 2019 financial results 76
6.3 Oct 03, 2019: genedrive: Audited final results 80
6.4 Sep 05, 2019: Biocartis announces H1 2019 results 85
6.5 Aug 07, 2019: Merck announces leadership changes to investor relations team 91
6.6 Aug 05, 2019: Quotient Limited Provides Updates on European Hypercare Launch, the CE Mark Submission and U.S. Field Trial for the Initial Serological Disease Screening Microarray, and Reports First Quarter Fiscal 2020 Results 91
6.7 Jul 30, 2019: Merck announces second-quarter 2019 financial results 93
6.8 Jul 02, 2019: Quotient Board announces contract extension of CEO Franz Walt 97
6.9 Jun 20, 2019: Merck hosts 2019 investor day outlining business momentum, strong expected growth and focus on innovative research and development 98
6.10 Jun 14, 2019: Drug Makers Sue to Block requirement for Listing Prices in TV Ads 98
7 Appendix 127
7.1 Methodology 127
7.2 About GlobalData 130
7.3 Contact Us 130
7.4 Disclaimer 130

List of Tables
Table 1: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 11
Table 2: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 12
Table 3: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 14
Table 4: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 15
Table 5: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Ongoing Clinical Trials 16
Table 6: Hepatitis Viruses Rapid Tests & Point of Care (POC) Companies - Pipeline Products by Stage of Development 17
Table 7: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 19
Table 8: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 21
Table 9: Point-Of-Care Test - Hepatitis C Virus RNA Detection - Product Status 21
Table 10: Point-Of-Care Test - Hepatitis C Virus RNA Detection - Product Description 21
Table 11: Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 22
Table 12: RDT - HCV Infection - Product Status 22
Table 13: RDT - HCV Infection - Product Description 22
Table 14: Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 23
Table 15: PIFA Hep B / Hep C - Product Status 23
Table 16: PIFA Hep B / Hep C - Product Description 23
Table 17: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 25
Table 18: Alere q Analyzer - HCV VL Assay - Product Status 25
Table 19: Alere q Analyzer - HCV VL Assay - Product Description 25
Table 20: Atomo Diagnostics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
Table 21: AtomoRapid - Hepatitis C - Product Status 26
Table 22: AtomoRapid - Hepatitis C - Product Description 26
Table 23: Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 27
Table 24: Idylla Viral Load Assay - HBV - Product Status 27
Table 25: Idylla Viral Load Assay - HBV - Product Description 27
Table 26: Idylla Viral Load Assay - HCV - Product Status 29
Table 27: Idylla Viral Load Assay - HCV - Product Description 29
Table 28: bioLytical Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 30
Table 29: INSTI Test - Hepatitis C - Product Status 30
Table 30: INSTI Test - Hepatitis C - Product Description 30
Table 31: Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 31
Table 32: Spinit Device - Hepatitis C Biomarker Assay - Product Status 31
Table 33: Spinit Device - Hepatitis C Biomarker Assay - Product Description 31
Table 34: Biotech Consortium India Ltd Pipeline Products & Ongoing Clinical Trials Overview 32
Table 35: Diagnostic Kit - Hepatitis A - Product Status 32
Table 36: Diagnostic Kit - Hepatitis A - Product Description 32
Table 37: Biotech Resources Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 34
Table 38: ATR-FTIR System - Hepatitis B & C - Product Status 34
Table 39: ATR-FTIR System - Hepatitis B & C - Product Description 34
Table 40: Blink AG Pipeline Products & Ongoing Clinical Trials Overview 35
Table 41: Point-Of-Care Test - Hepatitis C Virus RNA Detection - Product Status 35
Table 42: Point-Of-Care Test - Hepatitis C Virus RNA Detection - Product Description 35
Table 43: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 36
Table 44: GeneXpert Omni - HCV Viral Load - Product Status 36
Table 45: GeneXpert Omni - HCV Viral Load - Product Description 36
Table 46: Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 37
Table 47: DPP Hepatitis C Virus Assay - Product Status 37
Table 48: DPP Hepatitis C Virus Assay - Product Description 37
Table 49: Next Generation DPP HCV Assay - Product Status 38
Table 50: Next Generation DPP HCV Assay - Product Description 38
Table 51: Rapid Diagnostic Test - HCV - Product Status 38
Table 52: Rapid Diagnostic Test - HCV - Product Description 38
Table 53: ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 39
Table 54: Diagnostic Assay - Hepatitis C - Product Status 39
Table 55: Diagnostic Assay - Hepatitis C - Product Description 39
Table 56: Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 40
Table 57: Molecular Diagnostic Kit - Hepatitis B - Product Status 40
Table 58: Molecular Diagnostic Kit - Hepatitis B - Product Description 40
Table 59: Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 60: Diagnostic Test - Hepatitis C - Product Status 41

List of Figures
Figure 1: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 10
Figure 2: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 11
Figure 3: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 12
Figure 4: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 13
Figure 5: Hepatitis Viruses Rapid Tests & Point of Care (POC) - Ongoing Clinical Trials 14
Filed in: Pharmaceutical, Pharmaceuticals and Healthcare
Publisher : GlobalData