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

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

Medical Devices sector report, Retrovirus Rapid Tests & Point of Care (POC) - Medical Devices Pipeline Assessment, 2019" provides an overview of Retrovirus Rapid Tests & Point of Care (POC) 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 Retrovirus Rapid Tests & Point of Care (POC) pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by 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 Retrovirus Rapid Tests & Point of Care (POC) 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 Retrovirus Rapid Tests & Point of Care (POC) 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 Retrovirus Rapid Tests & Point of Care (POC) 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 products current stage of development, territory and estimated launch date

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 Oral Fluid Assay - Product Status 39
Table 59: Next Generation DPP HIV 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

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