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

2019-12-01
Price :
Published : Dec-2019
No. of Pages : 123
Table of Contents
1.1 List of Tables 5
1.2 List of Figures 8
2 Introduction 9
2.1 Retrovirus Rapid Tests & Point of Care (POC) Overview 9
Retrovirus Rapid Tests & Point of Care are the rapid diagnostic tests used to detect the HIV 1 and HIV 2 (human immunodeficiency virus) viruses and generate results immediately in a limited resource setting. 9
3 Products under Development 10
3.1 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 10
3.2 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Territory 11
3.3 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Regulatory Path 12
3.4 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Estimated Approval Date 13
4 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products under Development by Companies 14
4.1 Retrovirus Rapid Tests & Point of Care (POC) Companies - Pipeline Products by Stage of Development 14
4.2 Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 16
5 Retrovirus Rapid Tests & Point of Care (POC) Companies and Product Overview 18
5.1 Access Bio Inc Company Overview 18
5.1.1 Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 18
5.2 Akers Biosciences Inc Company Overview 19
5.2.1 Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 19
5.3 Aldatu Biosciences Inc Company Overview 20
5.3.1 Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 20
5.4 Alere Inc Company Overview 21
5.4.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 Altratech Ltd Company Overview 22
5.5.1 Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 22
5.6 BBB Technologies Inc Company Overview 23
5.6.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 23
5.7 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Company Overview 24
5.7.1 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24
5.8 Binx Health Inc Company Overview 25
5.8.1 Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 25
5.9 Bio-AMD Inc Company Overview 26
5.9.1 Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 26
5.10 Biocartis Group NV Company Overview 27
5.10.1 Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 27
5.11 BioHelix Corp Company Overview 28
5.11.1 BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 28
5.12 Calypte Biomedical Corporation Company Overview 30
5.12.1 Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 30
5.13 Centre International de Reference Chantal Biya Company Overview 32
5.13.1 Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 32
5.14 Cepheid Company Overview 33
5.14.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 33
5.15 Chembio Diagnostic Systems Inc Company Overview 35
5.15.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 35
5.16 CrossLife Technologies Inc Company Overview 38
5.16.1 CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 38
5.17 Daktari Diagnostics, Inc. Company Overview 39
5.17.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39
5.18 Diagnostics For All Inc Company Overview 40
5.18.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 40
5.19 Diagnostics for the Real World (Europe) Ltd Company Overview 41
5.19.1 Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 41
5.20 Endeavor Sciences Inc Company Overview 42
5.20.1 Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 42
5.21 Epinex Diagnostics Inc Company Overview 43
5.21.1 Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 43
5.22 ERBA Molecular Ltd Company Overview 44
5.22.1 ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 44
5.23 GAIA Medical Institute LLC Company Overview 45
5.23.1 GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 45
5.24 genedrive plc Company Overview 46
5.24.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 46
5.25 Group K Diagnostics Company Overview 47
5.25.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 47
5.26 HeatFlow Technologies Inc Company Overview 48
5.26.1 HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 48
5.27 Imperial College London Company Overview 49
5.27.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 49
5.28 Jinvator Bio Med GmbH Company Overview 50
5.28.1 Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 50
5.29 Johns Hopkins University Company Overview 51
5.29.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 51
5.30 Labsystems Diagnostics Oy Company Overview 52
5.30.1 Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 52
5.31 Micronics Inc Company Overview 53
5.31.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 53
5.32 Molbio Diagnostics Pvt Ltd Company Overview 55
5.32.1 Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 55
5.33 Nanobiosym Inc Company Overview 56
5.33.1 Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 56
5.34 NeuMoDx Molecular Inc Company Overview 57
5.34.1 NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 57
5.35 Newmark Diagnostics LLC Company Overview 58
5.35.1 Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 58
5.36 Northwestern University Company Overview 59
5.36.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 59
5.37 Orangelife Company Overview 60
5.37.1 Orangelife Pipeline Products & Ongoing Clinical Trials Overview 60
5.38 Osel Inc Company Overview 61
5.38.1 Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 61
5.39 QuantuMDx Group Ltd Company Overview 62
5.39.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 62
5.40 Quidel Corp Company Overview 63
5.40.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 63
5.41 Radisens Diagnostics Ltd Company Overview 64
5.41.1 Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 64
5.42 Rheonix Inc Company Overview 65
5.42.1 Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 65
5.43 Roche Diagnostics International Ltd Company Overview 66
5.43.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 66
5.44 Sedia Biosciences Corp Company Overview 67
5.44.1 Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 67
5.45 TheoremDx Inc Company Overview 69
5.45.1 TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 69
5.46 Trinity Biotech Plc Company Overview 70
5.46.1 Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 70
5.47 University of Washington Company Overview 71
5.47.1 University of Washington Pipeline Products & Ongoing Clinical Trials Overview 71
5.48 UrSure Inc Company Overview 72
5.48.1 UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 72
5.49 Wave 80 Biosciences Inc Company Overview 73
5.49.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 73
5.50 Yaathum Biotech Pvt Ltd Company Overview 75
5.50.1 Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 75
6 Retrovirus Rapid Tests & Point of Care (POC) - Recent Developments 76
6.1 Nov 04, 2019: Chembio Diagnostics receives WHO Prequalification Approval for HIV Self-Test 76
6.2 Oct 30, 2019: Quidel reports third quarter 2019 financial results 76
6.3 Oct 17, 2019: Chembio Diagnostics receives WHO prequalification approval for Malaysia facility 78
6.4 Oct 16, 2019: Trinity Biotech announces results for Q3, 2019 78
6.5 Oct 15, 2019: Johnson & Johnson reports 2019 Third-Quarter Results 80
6.6 Sep 30, 2019: Johnson & Johnson appoints Carlton Lawson to area Managing Director, Consumer, Northern Europe 81
6.7 Sep 19, 2019: INSTI now available for expanded point-of-care use in Canada 81
6.8 Sep 16, 2019: Omega Diagnostics Group: Update on VISITECT CD4 Advanced Disease 82
6.9 Sep 05, 2019: Biocartis announces H1 2019 results 83
6.10 Aug 20, 2019: First purchase order for VISITECT CD4 advanced disease test 88
7 Appendix 120
7.1 Methodology 120
7.2 About GlobalData 123
7.3 Contact Us 123
7.4 Disclaimer 123

List of Tables
Table 1: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 11
Table 2: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Territory 12
Table 3: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Regulatory Path 13
Table 4: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Estimated Approval Date 14
Table 5: Retrovirus Rapid Tests & Point of Care (POC) Companies - Pipeline Products by Stage of Development 15
Table 6: Retrovirus Rapid Tests & Point of Care (POC) -Pipeline Products by Stage of Development 17
Table 7: Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 19
Table 8: CareUS HIV Rapid Diagnostic Test - Product Status 19
Table 9: CareUS HIV Rapid Diagnostic Test - Product Description 19
Table 10: Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 21
Table 11: PIFA HIV 1+2 Rapid Assay - Product Status 21
Table 12: PIFA HIV 1+2 Rapid Assay - Product Description 21
Table 13: Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 23
Table 14: PANDAA HIV6 - Product Status 23
Table 15: PANDAA HIV6 - Product Description 23
Table 16: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 24
Table 17: Alere q HIV-1/2 VL Plasma Assay - Product Status 24
Table 18: Alere q HIV-1/2 VL Plasma Assay - Product Description 24
Table 19: Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 25
Table 20: Point-Of-Care Test - HIV Infection - Product Status 25
Table 21: Point-Of-Care Test - HIV Infection - Product Description 25
Table 22: BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 26
Table 23: Mobile RDT Reader - HIV1/2 Test - Product Status 26
Table 24: Mobile RDT Reader - HIV1/2 Test - Product Description 26
Table 25: Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
Table 26: Urine Based Rapid HIV Test - Product Status 27
Table 27: Urine Based Rapid HIV Test - Product Description 27
Table 28: Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 28
Table 29: Atlas io System - HIV Assay - Product Status 28
Table 30: Atlas io System - HIV Assay - Product Description 28
Table 31: Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 29
Table 32: Digital Strip Reader - HIV Test - Product Status 29
Table 33: Digital Strip Reader - HIV Test - Product Description 29
Table 34: Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 30
Table 35: Idylla Viral Load Assay - HIV - Product Status 30
Table 36: Idylla Viral Load Assay - HIV - Product Description 30
Table 37: BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 31
Table 38: IsoAmp Assay - HIV - Product Status 31
Table 39: IsoAmp Assay - HIV - Product Description 31
Table 40: IsoAmp HIV-1 Quantitative Assay - Product Status 32
Table 41: IsoAmp HIV-1 Quantitative Assay - Product Description 32
Table 42: Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 33
Table 43: Aware 2 HIV-1/2 - Product Status 33
Table 44: Aware 2 HIV-1/2 - Product Description 33
Table 45: Aware HIV-1/2 OMT - Product Status 34
Table 46: Aware HIV-1/2 OMT - Product Description 34
Table 47: Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 35
Table 48: Point-Of-Care Diagnostic Test - HIV-1 - Product Status 35
Table 49: Point-Of-Care Diagnostic Test - HIV-1 - Product Description 35
Table 50: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 36
Table 51: GeneXpert Omni - HIV-1 Qualitative Test - Product Status 36
Table 52: GeneXpert Omni - HIV-1 Qualitative Test - Product Description 36
Table 53: GeneXpert Omni - HIV-1 Viral Load Test - Product Status 37
Table 54: GeneXpert Omni - HIV-1 Viral Load Test - Product Description 37
Table 55: Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 38
Table 56: DPP HIV Ag-Ab Assay - Product Status 38
Table 57: DPP HIV Ag-Ab Assay - Product Description 38
Table 58: Next Generation DPP HIV ½ Oral Fluid Assay - Product Status 39
Table 59: Next Generation DPP HIV ½ Oral Fluid Assay - Product Description 39
Table 60: Sure Check HIV OTC Assay - Product Status 39

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