Retroviruses Rapid Tests & Point of Care (POC) - Medical Devices Pipeline Assessment, 2017

2017-09-01
Price :
Published : Sep-2017
No. of Pages : 105
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 7
2 Introduction 8
2.1 Retroviruses Rapid Tests & Point of Care (POC) Overview 8
3 Products under Development 9
3.1 Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 9
3.2 Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 10
3.3 Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 11
3.4 Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 12
4 Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products under Development by Companies 13
4.1 Retroviruses Rapid Tests & Point of Care (POC) Companies - Pipeline Products by Stage of Development 13
4.2 Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 15
5 Retroviruses Rapid Tests & Point of Care (POC) 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 Aldatu Biosciences, Inc. Company Overview 19
5.2.1 Aldatu Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
5.3 Atomo Diagnostics Pty Limited Company Overview 20
5.3.1 Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 20
5.4 BBB Technologies Inc Company Overview 21
5.4.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 Bio-Alternative Medical Devices Ltd Company Overview 22
5.5.1 Bio-Alternative Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 22
5.6 Biocartis SA Company Overview 23
5.6.1 Biocartis SA Pipeline Products & Ongoing Clinical Trials Overview 23
5.7 Biosynex SA Company Overview 24
5.7.1 Biosynex SA Pipeline Products & Ongoing Clinical Trials Overview 24
5.8 Calypte Biomedical Corporation Company Overview 25
5.8.1 Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 25
5.9 Centre International de Reference Chantal Biya Company Overview 27
5.9.1 Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 27
5.10 Cepheid Company Overview 28
5.10.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 28
5.11 Chembio Diagnostic Systems Inc Company Overview 31
5.11.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 31
5.12 Daktari Diagnostics, Inc. Company Overview 34
5.12.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.13 Diagnostics For All Company Overview 36
5.13.1 Diagnostics For All Pipeline Products & Ongoing Clinical Trials Overview 36
5.14 Diagnostics for the Real World (Europe) Ltd. Company Overview 37
5.14.1 Diagnostics for the Real World (Europe) Ltd. Pipeline Products & Ongoing Clinical Trials Overview 37
5.15 Epinex Diagnostics Inc Company Overview 38
5.15.1 Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 38
5.16 ERBA Molecular Ltd Company Overview 39
5.16.1 ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 39
5.17 GAIA Medical Institute LLC Company Overview 40
5.17.1 GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 40
5.18 genedrive plc Company Overview 41
5.18.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 41
5.19 Group K Diagnostics Company Overview 42
5.19.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 42
5.20 HeatFlow Technologies Inc Company Overview 43
5.20.1 HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 43
5.21 Jinvator Bio Med GmbH Company Overview 44
5.21.1 Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 44
5.22 John Hopkins University Company Overview 45
5.22.1 John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 45
5.23 Labsystems Diagnostics Oy Company Overview 46
5.23.1 Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 46
5.24 Micronics Inc Company Overview 47
5.24.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 47
5.25 Molbio Diagnostics Pvt. Ltd. Company Overview 49
5.25.1 Molbio Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 49
5.26 Northwestern Global Health Foundation Company Overview 50
5.26.1 Northwestern Global Health Foundation Pipeline Products & Ongoing Clinical Trials Overview 50
5.27 NOWDiagnostics Company Overview 51
5.27.1 NOWDiagnostics Pipeline Products & Ongoing Clinical Trials Overview 51
5.28 Omega Diagnostics Group Plc Company Overview 52
5.28.1 Omega Diagnostics Group Plc Pipeline Products & Ongoing Clinical Trials Overview 52
5.29 OPKO Health Inc Company Overview 53
5.29.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 53
5.30 OraSure Technologies Inc Company Overview 54
5.30.1 OraSure Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 54
5.31 Osel Inc Company Overview 55
5.31.1 Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 55
5.32 QuantuMDx Group Ltd Company Overview 56
5.32.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 56
5.33 Quidel Corp Company Overview 57
5.33.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 57
5.34 Radisens Diagnostics Ltd Company Overview 60
5.34.1 Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 60
5.35 Rheonix Inc Company Overview 61
5.35.1 Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 61
5.36 Roche Diagnostics International Ltd Company Overview 62
5.36.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 62
5.37 Sedia Biosciences Corp Company Overview 63
5.37.1 Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 63
5.38 Trinity Biotech Plc Company Overview 65
5.38.1 Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 65
5.39 Wave 80 Biosciences Inc Company Overview 66
5.39.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 66
6 Retroviruses Rapid Tests & Point of Care (POC)- Recent Developments 68
6.1 Jul 26, 2017: Quidel Reports Second Quarter 2017 Financial Results 68
6.2 Jul 24, 2017: OraQuick HIV Self-Test Selected for Next Phase of STAR Project for HIV Self-Testing in Africa 69
6.3 Jul 21, 2017: OraSure Technologies Receives World Health Organization Prequalification of OraQuick HIV Self-Test 70
6.4 Jul 20, 2017: Trinity Biotech Announces Results for Q2, 2017 71
6.5 Jul 18, 2017: Johnson & Johnson Reports 2017 Second-Quarter Results 72
6.6 Jun 27, 2017: OraSure Technologies to Drive Accelerated Adoption of OraQuick HIV Self-Test 74
6.7 May 17, 2017: VANC Pharmaceuticals Announces Canadian Distribution Agreement for INSTI HIV-1/HIV-2 Antibody Test 75
6.8 May 16, 2017: NOWDiagnostics CEO Kevin Clark to Address Technology Conference 76
6.9 May 03, 2017: Chembio Secures $5.8 Million Bio-Manguinhos Order to Supply Components for Production of DPP HIV 1/2 Assay in Brazil 76
6.10 Apr 27, 2017: Trinity Biotech Announces Results for Q1, 2017 77
6.11 Apr 24, 2017: Quidel Reports First Quarter 2017 Financial Results 78
6.12 Apr 19, 2017: Johnson & Johnson reports Q1 2017 results 79
6.13 Apr 18, 2017: Johnson & Johnson Reports 2017 First-Quarter Results 81
6.14 Mar 14, 2017: Trinity Biotech announces Quarter 4 and Fiscal Year 2016 Financial Results 83
6.15 Mar 01, 2017: OraSure Receives Global Fund Classification to Enable HIV Self-Test Procurement 86
6.16 Feb 21, 2017: BioLytical Receives Innovative Technology Contract from Vizient for Rapid HIV Test 86
6.17 Feb 08, 2017: Quidel Reports Fourth Quarter and Full Year 2016 Financial Results 87
6.18 Jan 24, 2017: Johnson & Johnson Reports 2016 Fourth-Quarter Results 88
6.19 Jan 23, 2017: Quidel Announces Modification of Revenue Reporting Categories 90
6.20 Jan 09, 2017: Johnson & Johnson Medical Devices Companies Launch CareAdvantage, a Suite of Holistic, Insights-Driven Capabilities to Help U.S. Health Systems Navigate Value-Based Care 91
6.21 Jan 06, 2017: Quidel Announces Preliminary Revenue for Fourth Quarter 2016 92
6.22 Dec 01, 2016: Daktari Awarded $1.3 Million NIH SBIR Grant for HIV Point-of-Care Diagnostic 92
6.23 Oct 26, 2016: Quidel Reports Third Quarter 2016 Financial Results 93
6.24 Oct 25, 2016: Trinity Biotech announces Quarter 3 Financial Results 94
6.25 Oct 25, 2016: Researchers Use CRISPR to Accelerate Search for HIV Cure 97
6.26 Oct 18, 2016: Johnson & Johnson Reports 2016 Third-Quarter Results 98
6.27 Sep 08, 2016: Cepheid Targets Development of a Point of Care HIV Viral Load Test From a Few Drops of Blood 100
7 Appendix 102
7.1 Methodology 102
7.2 About GlobalData 105
7.3 Contact Us 105
7.4 Disclaimer 105

1.1 List of Tables
Table 1: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 9
Table 2: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 10
Table 3: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 11
Table 4: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 12
Table 5: Retroviruses Rapid Tests & Point of Care (POC) Companies - Pipeline Products by Stage of Development 13
Table 6: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 15
Table 7: Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 17
Table 8: PIFA HIV 1+2 Rapid Assay - Product Status 17
Table 9: PIFA HIV 1+2 Rapid Assay - Product Description 18
Table 10: Aldatu Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
Table 11: PANDAA HIV6 - Product Status 19
Table 12: PANDAA HIV6 - Product Description 19
Table 13: Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 20
Table 14: AtomoRapid HIV - Product Status 20
Table 15: AtomoRapid HIV - Product Description 20
Table 16: BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 21
Table 17: Mobile RDT Reader - HIV1/2 Test - Product Status 21
Table 18: Mobile RDT Reader - HIV1/2 Test - Product Description 21
Table 19: Bio-Alternative Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 22
Table 20: Digital Strip Reader - HIV - Product Status 22
Table 21: Digital Strip Reader - HIV - Product Description 22
Table 22: Biocartis SA Pipeline Products & Ongoing Clinical Trials Overview 23
Table 23: Idylla Viral Load Assay - HIV - Product Status 23
Table 24: Idylla Viral Load Assay - HIV - Product Description 23
Table 25: Biosynex SA Pipeline Products & Ongoing Clinical Trials Overview 24
Table 26: Exacto HIV Screening Test - Product Status 24
Table 27: Exacto HIV Screening Test - Product Description 24
Table 28: Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 25
Table 29: Aware 2 HIV-1/2 - Product Status 25
Table 30: Aware 2 HIV-1/2 - Product Description 25
Table 31: Aware HIV-1/2 OMT - Product Status 26
Table 32: Aware HIV-1/2 OMT - Product Description 26
Table 33: Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 27
Table 34: Point-Of-Care Diagnostic Test - HIV-1 - Product Status 27
Table 35: Point-Of-Care Diagnostic Test - HIV-1 - Product Description 27
Table 36: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 28
Table 37: GeneXpert Omni - Xpert HIV-1 Qualitative - Product Status 28
Table 38: GeneXpert Omni - Xpert HIV-1 Qualitative - Product Description 28
Table 39: GeneXpert Omni - Xpert HIV-1 Viral Load - Product Status 29
Table 40: GeneXpert Omni - Xpert HIV-1 Viral Load - Product Description 29
Table 41: Xpert Finger Stick HIV-1 Viral Load Assay - Product Status 29
Table 42: Xpert Finger Stick HIV-1 Viral Load Assay - Product Description 30
Table 43: Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 44: DPP HIV Ag-Ab Assay - Product Status 31
Table 45: DPP HIV Ag-Ab Assay - Product Description 31
Table 46: Next Generation DPP HIV ½ Oral Fluid Assay - Product Status 32
Table 47: Next Generation DPP HIV ½ Oral Fluid Assay - Product Description 32
Table 48: Sure Check HIV OTC Assay - Product Status 32
Table 49: Sure Check HIV OTC Assay - Product Description 33
Table 50: Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 51: Aspect - HIV Viral Load Test - Product Status 34
Table 52: Aspect - HIV Viral Load Test - Product Description 34
Table 53: HIV Viral Load Test - Product Status 35
Table 54: HIV Viral Load Test - Product Description 35
Table 55: Diagnostics For All Pipeline Products & Ongoing Clinical Trials Overview 36
Table 56: Paper-Based Microfluidic Device - HIV - Product Status 36
Table 57: Paper-Based Microfluidic Device - HIV - Product Description 36
Table 58: Diagnostics for the Real World (Europe) Ltd. Pipeline Products & Ongoing Clinical Trials Overview 37
Table 59: SAMBA - HIV-1 Viral Load Assay - Product Status 37
Table 60: SAMBA - HIV-1 Viral Load Assay - Product Description 37
Table 61: Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 38
Table 62: Epinex G1A - Neo-natal HIV Test - Product Status 38
Table 63: Epinex G1A - Neo-natal HIV Test - Product Description 38
Table 64: ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 39
Table 65: Next Generation HIV Viral Load Monitoring Test - Product Status 39
Table 66: Next Generation HIV Viral Load Monitoring Test - Product Description 39
Table 67: GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 40
Table 68: Point-Of-Care Diagnostic Test - HIV - Product Status 40
Table 69: Point-Of-Care Diagnostic Test - HIV - Product Description 40
Table 70: genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 71: Genedrive - HIV Assay - Product Status 41
Table 72: Genedrive - HIV Assay - Product Description 41
Table 73: Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 42
Table 74: Multidiagnostic - HIV Load Test - Product Status 42
Table 75: Multidiagnostic - HIV Load Test - Product Description 42
Table 76: HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 43
Table 77: HF-PCR Point Of Care HIV Viral Load Assay - Product Status 43
Table 78: HF-PCR Point Of Care HIV Viral Load Assay - Product Description 43
Table 79: Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 44
Table 80: nanoGold Test - Product Status 44
Table 81: nanoGold Test - Product Description 44
Table 82: John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 45
Table 83: Point-Of-Care Test - Pediatric HIV - Product Status 45
Table 84: Point-Of-Care Test - Pediatric HIV - Product Description 45
Table 85: Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 46
Table 86: Biocard HIV (1+2) Test - Product Status 46
Table 87: Biocard HIV (1+2) Test - Product Description 46
Table 88: Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 47
Table 89: MTCT - HIV Assay - Product Status 47
Table 90: MTCT - HIV Assay - Product Description 47
Table 91: PanNAT - HIV Assay - Product Status 48
Table 92: PanNAT - HIV Assay - Product Description 48
Table 93: Molbio Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 49
Table 94: Truenat HIV Viral Load Assay - Product Status 49
Table 95: Truenat HIV Viral Load Assay - Product Description 49
Table 96: Northwestern Global Health Foundation Pipeline Products & Ongoing Clinical Trials Overview 50
Table 97: LYNX HIV p24 Antigen Test - Product Status 50
Table 98: LYNX HIV p24 Antigen Test - Product Description 50
Table 99: NOWDiagnostics Pipeline Products & Ongoing Clinical Trials Overview 51
Table 100: ADEXUSDx HIV Test - Product Status 51
Table 101: ADEXUSDx HIV Test - Product Description 51
Table 102: Omega Diagnostics Group Plc Pipeline Products & Ongoing Clinical Trials Overview 52
Table 103: VISITECT CD4 Test - Product Status 52
Table 104: VISITECT CD4 Test - Product Description 52
Table 105: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 106: Diagnostic Assay - HIV - Product Status 53
Table 107: Diagnostic Assay - HIV - Product Description 53
Table 108: OraSure Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 54
Table 109: Next Generation OraQuick Rapid HIV Test - Product Status 54
Table 110: Next Generation OraQuick Rapid HIV Test - Product Description 54
Table 111: Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 55
Table 112: Point-Of-Care Diagnostic Test - HIV-1 Infection - Product Status 55
Table 113: Point-Of-Care Diagnostic Test - HIV-1 Infection - Product Description 55
Table 114: QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 56
Table 115: Q-POC - HIV Assay - Product Status 56
Table 116: Q-POC - HIV Assay - Product Description 56
Table 117: Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 57
Table 118: HIV POC RT-PCR Testing Device - Product Status 57
Table 119: HIV POC RT-PCR Testing Device - Product Description 57
Table 120: IsoAmp Assay - HIV - Product Status 58
Table 121: IsoAmp Assay - HIV - Product Description 58
Table 122: IsoAmp HIV-1 Quantitative Assay - Product Status 58
Table 123: IsoAmp HIV-1 Quantitative Assay - Product Description 59
Table 124: Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 60
Table 125: Diagnostic Panel - HIV - Product Status 60
Table 126: Diagnostic Panel - HIV - Product Description 60
Table 127: Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 61
Table 128: Rheonix CARD - HIV Assay - Product Status 61
Table 129: Rheonix CARD - HIV Assay - Product Description 61
Table 130: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 62
Table 131: Liat HIV-1 Viral Load Assay - Product Status 62
Table 132: Liat HIV-1 Viral Load Assay - Product Description 62
Table 133: Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 63
Table 134: Asanté Rapid HIV-1 Recency (or Incidence) Assay - Product Status 63
Table 135: Asanté Rapid HIV-1 Recency (or Incidence) Assay - Product Description 63
Table 136: Rapid Oral Fluid HIV Test - Product Status 64
Table 137: Rapid Oral Fluid HIV Test - Product Description 64
Table 138: Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 65
Table 139: Uni-Gold HIV Ag/Ab Combo Test - Product Status 65
Table 140: Uni-Gold HIV Ag/Ab Combo Test - Product Description 65
Table 141: Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 66
Table 142: EOSCAPE HIV-1 RNA Viral Load Test - Product Status 66
Table 143: EOSCAPE HIV-1 RNA Viral Load Test - Product Description 66
Table 144: EOSCAPE-HIV RNA PLUS - Product Status 67
Table 145: EOSCAPE-HIV RNA PLUS - Product Description 67
Table 146: Glossary 104

1.2 List of Figures
Figure 1: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 9
Figure 2: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 10
Figure 3: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 11
Figure 4: Retroviruses Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 12
Filed in: Medical Device
Publisher : GlobalData