Human Immunodeficiency Virus (HIV) Tests Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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HIV Tests Pipeline Market Report Overview

Human Immunodeficiency Virus (HIV) tests refer to the antigens, antibodies, and nucleic acid reagent tests performed for the detection of HIV type I. The HIV Tests pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segments ·        CD4 Count Tests

·        HIV Point of Care (POC) Tests

·        HIV Enzyme Immuno Assay/Enzyme-Linked Immunosorbent Assay (EIA/ELISA) Tests

·        HIV Nucleic Acid Amplification Tests (NAATs)

Key Territories ·        The US

·        Europe

·        India

·        China

·        Japan

·        South Korea

Key Regulatory Paths ·        PMA

·        CE-IVD

·        510(k)

·        ICAC

·        NMPA

·        Shonin

Leading Companies ·        Abbott Diagnostics

·        Accelevir Diagnostics LLC

·        Aldatu Biosciences Inc

·        Alere Inc

·        Allied Innovative Systems, LLC

·        Altratech Ltd

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HIV Tests Pipeline Market by Segments

The key segments in the HIV Tests pipeline market are CD4 Count Tests, HIV Point of Care (POC) Tests, HIV Enzyme Immuno Assay/Enzyme-Linked Immunosorbent Assay (EIA/ELISA) Tests, and HIV Nucleic Acid Amplification Tests (NAATs). As of February 2024, HIV Point of Care (POC) Tests account for the highest number of pipeline products. POC is typically performed by non-laboratory personnel and the results are used for clinical decision making. POC has a range of complexity and procedures that vary from manual methodologies to automated analyzers.

HIV Tests Pipeline Market Analysis by Segments, 2024 (%)

HIV Tests Pipeline Market Analysis by Segments, 2024 (%)

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HIV Tests Pipeline Market Segmentation by Territories

A few of the key territories for HIV Tests pipeline products are the US, Europe, India, China, Japan, and South Korea among others. As of February 2024, the US accounts for the highest number of pipeline products.

HIV Tests Pipeline Market Analysis by Territories, 2024 (%)

HIV Tests Pipeline Market Analysis by Territories, 2024 (%)

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HIV Tests Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the HIV Tests pipeline market are PMA, CE-IVD, 510(k), ICAC, NMPA, and Shonin among others. As of February 2024, PMA is the most followed pathway for pipeline products in the market.

HIV Tests Pipeline Market Analysis by Regulatory Paths, 2023 (%)

HIV Tests Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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HIV Tests Pipeline Market – Competitive Landscape

A few of the key companies associated with the HIV Tests pipeline market are Abbott Diagnostics, Accelevir Diagnostics LLC, Aldatu Biosciences Inc., Alere Inc., Allied Innovative Systems, LLC, and Altratech Ltd among others.

Abbott Diagnostics (Abbott): The US-based Abbott Diagnostics is a subsidiary of Abbott Laboratories. The company manufactures in vitro diagnostic systems and tests. It offers various core laboratory products, molecular point-of-care products, transfusion medicine, professional services, and diagnostics. Abbott’s product portfolio includes laboratory systems for automation molecular diagnostic systems, and point-of-care systems for blood analysis. The company products find application in therapeutic drug monitoring, measurement of antibodies and antigens, and screening and diagnosis of cancer.

HIV Tests Pipeline Market Analysis by Companies, 2024

HIV Tests Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

HIV Tests Pipeline Market Segments Outlook

  • CD4 Count Tests
  • HIV Point of Care (POC) Tests
  • HIV Enzyme Immuno Assay/Enzyme-Linked Immunosorbent Assay (EIA/ELISA) Tests
  • HIV Nucleic Acid Amplification Tests (NAATs)

HIV Tests Pipeline Market Territories Outlook

  • The US
  • Europe
  • India
  • China
  • Japan
  • South Korea

HIV Tests Pipeline Market Regulatory Paths Outlook

  • PMA
  • CE-IVD
  • 510(k)
  • ICAC
  • NMPA
  • Shonin

Scope

This report provides:

  • Extensive coverage of the HIV Tests under development.
  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of HIV Tests and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of HIV Tests under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • Carry out In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Abbott Diagnostics
Accelevir Diagnostics LLC
Aldatu Biosciences Inc
Alere Inc
Allied Innovative Systems, LLC
Altratech Ltd
Atomo Diagnostics Ltd
Autoimmune Technologies LLC
Ayanda Biosystems SA (Inactive)
Baebies Inc
BBB Technologies Inc
Beijing Wantai Biological Pharmacy Enterprise Co Ltd
Binx Health Inc
Bio-AMD Inc
Biocartis Group NV
BioHelix Corp
Biokit SA
Biomagnetics Diagnostics Corp
Blackfly Investments LLC
Bluejay Diagnostics Inc
Calypte Biomedical Corporation
Cell Microsystems Inc
CeMines, Inc. (Inactive)
Centre International de Reference Chantal Biya
Cepheid Inc
Chembio Diagnostic Systems Inc
CHIP Diagnostics Inc
ChipCare Corp
Co-Diagnostics Inc
Conrad
Cornell University
CoSara Diagnostics Pvt Ltd
CrossLife Technologies Inc
Cue Inc
Cupid Ltd
Daktari Diagnostics, Inc.
Diagnostics For All Inc
Diagnostics for the Real World (Europe) Ltd
Diagnostics for the Real World Ltd
Discidium Biosciences LLC
DNAE Group Holdings Ltd
Drexel University
Enable Biosciences Inc
Endeavor Sciences Inc
Enzo Biochem Inc
Epinex Diagnostics Inc
ERBA Molecular Ltd
Eurobio Scientific SA
Fast Track Diagnostics Ltd
Fluxergy LLC
Fujirebio Diagnostics Inc
G Medical Health and Wellness
GAIA Medical Institute LLC
genedrive plc
Genome Diagnostics Pvt Ltd
Giner Inc
Goodgene Inc
Group K Diagnostics
Guangzhou Wondfo Biotech Co Ltd
HA TECH Pty Ltd
HeatFlow Technologies Inc
Identifysensors LLC
Immunetics Inc
Imperial College London
Institute for Development Research
Integrated Diagnostics Inc (Inactive)
Intelligent Bio Solutions Inc
Intuitive Biosciences Inc
Invex Health Pvt Ltd
IRIS International Inc
Jan Biotech Inc
Jinvator Bio Med GmbH
Johns Hopkins University
Labgene Biotech Pvt Ltd
Lynntech Inc
Maxim Biomedical Inc
MedMira Inc
MedNostic Technologies, LLC
Medosome Biotec LLC
Micronics Inc
Minute Molecular Diagnostics Inc (Inactive)
MND Diagnostic LTD
Molbio Diagnostics Pvt Ltd
MyMD Pharmaceuticals Inc
Nanobiosym Inc
NeuMoDx Molecular Inc
Newmark Diagnostics LLC
Northwestern University
Odyssey Thera, inc. (Inactive)
Oregon Health & Science University
Osel Inc
Paramedical Srl
Pathogenica Inc
PATHseq Diagnostics Inc
Penn State College of Medicine
Philmedi Co Ltd
PixCell Medical Technologies Ltd
Prenetics Ltd
Purdue University
QuantuMDx Group Ltd
Quidel Corp
Radisens Diagnostics Ltd
Redbud Labs Inc
Rheonix Inc
Rice University
Roche Diagnostics International Ltd
SD Biosensor Inc
Seattle Children's Hospital
Sedia Biosciences Corp
Seegene Inc
Sensible Diagnostics Inc
Senzo Inc
Shenzhen New Industries Biomedical Engineering Co Ltd
Siemens Healthineers AG
Stanford University
Syamala Srinivasa Life Sciences Pvt. Ltd
Taizhou ZECEN Biotech Co Ltd
TBG Diagnostics Ltd
TheoremDx Inc
TheraDiag SA
Trinity Biotech Plc
University of California San Diego
University of Connecticut
University of Michigan
University of Minnesota
University of the Philippines Manila
University of the Western Cape
University of Washington
UrSure Inc
Ustar Biotechnologies (Hangzhou) Ltd
VEGA Ltd
Viravaxx AG
Virax Biolabs Group Ltd
Wave 80 Biosciences Inc
Yaathum Biotech Pvt Ltd

Table of Contents

1 Table of Contents 3

1.1 List of Tables 9

1.2 List of Figures 18

2 Introduction 19

2.1 Human Immunodeficiency Virus (HIV) Tests Overview 19

3 Products under Development 20

3.1 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 20

3.2 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Segment 21

3.3 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Territory 22

3.4 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Regulatory Path 24

3.5 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Estimated Approval Date 25

3.6 Human Immunodeficiency Virus (HIV) Tests – Ongoing Clinical Trials 26

4 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products under Development by Companies 27

4.1 Human Immunodeficiency Virus (HIV) Tests Companies – Pipeline Products by Stage of Development 27

4.2 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 32

5 Human Immunodeficiency Virus (HIV) Tests Companies and Product Overview 37

5.1 Abbott Diagnostics Company Overview 37

5.1.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 37

5.2 Accelevir Diagnostics LLC Company Overview 40

5.2.1 Accelevir Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 40

5.3 Aldatu Biosciences Inc Company Overview 43

5.3.1 Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.4 Alere Inc Company Overview 46

5.4.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.5 Allied Innovative Systems, LLC Company Overview 48

5.5.1 Allied Innovative Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 48

5.6 Altratech Ltd Company Overview 49

5.6.1 Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.7 Atomo Diagnostics Ltd Company Overview 50

5.7.1 Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

5.8 Autoimmune Technologies LLC Company Overview 52

5.8.1 Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 52

5.9 Ayanda Biosystems SA (Inactive) Company Overview 53

5.9.1 Ayanda Biosystems SA (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 53

5.10 Baebies Inc Company Overview 54

5.10.1 Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.11 BBB Technologies Inc Company Overview 55

5.11.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.12 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Company Overview 56

5.12.1 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

5.13 Binx Health Inc Company Overview 57

5.13.1 Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.14 Bio-AMD Inc Company Overview 58

5.14.1 Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 58

5.15 Biocartis Group NV Company Overview 59

5.15.1 Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 59

5.16 BioHelix Corp Company Overview 60

5.16.1 BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 60

5.17 Biokit SA Company Overview 61

5.17.1 Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 61

5.18 Biomagnetics Diagnostics Corp Company Overview 62

5.18.1 Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 62

5.19 Blackfly Investments LLC Company Overview 64

5.19.1 Blackfly Investments LLC Pipeline Products & Ongoing Clinical Trials Overview 64

5.20 Bluejay Diagnostics Inc Company Overview 65

5.20.1 Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 65

5.21 Calypte Biomedical Corporation Company Overview 66

5.21.1 Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 66

5.22 Cell Microsystems Inc Company Overview 68

5.22.1 Cell Microsystems Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.23 CeMines, Inc. (Inactive) Company Overview 69

5.23.1 CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 69

5.24 Centre International de Reference Chantal Biya Company Overview 70

5.24.1 Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 70

5.25 Cepheid Inc Company Overview 71

5.25.1 Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.26 Chembio Diagnostic Systems Inc Company Overview 74

5.26.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.27 CHIP Diagnostics Inc Company Overview 78

5.27.1 CHIP Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.28 ChipCare Corp Company Overview 79

5.28.1 ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 79

5.29 Co-Diagnostics Inc Company Overview 80

5.29.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.30 Conrad Company Overview 81

5.30.1 Conrad Pipeline Products & Ongoing Clinical Trials Overview 81

5.31 Cornell University Company Overview 82

5.31.1 Cornell University Pipeline Products & Ongoing Clinical Trials Overview 82

5.32 CoSara Diagnostics Pvt Ltd Company Overview 83

5.32.1 CoSara Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

5.33 CrossLife Technologies Inc Company Overview 84

5.33.1 CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 84

5.34 Cue Inc Company Overview 85

5.34.1 Cue Inc Pipeline Products & Ongoing Clinical Trials Overview 85

5.35 Cupid Ltd Company Overview 86

5.35.1 Cupid Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

5.36 Daktari Diagnostics, Inc. Company Overview 87

5.36.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87

5.37 Diagnostics For All Inc Company Overview 88

5.37.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 88

5.38 Diagnostics for the Real World (Europe) Ltd Company Overview 89

5.38.1 Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

5.39 Diagnostics for the Real World Ltd Company Overview 92

5.39.1 Diagnostics for the Real World Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

5.40 Discidium Biosciences LLC Company Overview 93

5.40.1 Discidium Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 93

5.41 DNAE Group Holdings Ltd Company Overview 94

5.41.1 DNAE Group Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

5.42 Drexel University Company Overview 95

5.42.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 95

5.43 Enable Biosciences Inc Company Overview 96

5.43.1 Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.44 Endeavor Sciences Inc Company Overview 97

5.44.1 Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 97

5.45 Enzo Biochem Inc Company Overview 98

5.45.1 Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 98

5.46 Epinex Diagnostics Inc Company Overview 99

5.46.1 Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 99

5.47 ERBA Molecular Ltd Company Overview 100

5.47.1 ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 100

5.48 Eurobio Scientific SA Company Overview 103

5.48.1 Eurobio Scientific SA Pipeline Products & Ongoing Clinical Trials Overview 103

5.49 Fast Track Diagnostics Ltd Company Overview 106

5.49.1 Fast Track Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

5.50 Fluxergy LLC Company Overview 107

5.50.1 Fluxergy LLC Pipeline Products & Ongoing Clinical Trials Overview 107

5.51 Fujirebio Diagnostics Inc Company Overview 108

5.51.1 Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.52 G Medical Health and Wellness Company Overview 111

5.52.1 G Medical Health and Wellness Pipeline Products & Ongoing Clinical Trials Overview 111

5.53 GAIA Medical Institute LLC Company Overview 112

5.53.1 GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 112

5.54 genedrive plc Company Overview 113

5.54.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 113

5.55 Genome Diagnostics Pvt Ltd Company Overview 114

5.55.1 Genome Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

5.56 Giner Inc Company Overview 117

5.56.1 Giner Inc Pipeline Products & Ongoing Clinical Trials Overview 117

5.57 Goodgene Inc Company Overview 118

5.57.1 Goodgene Inc Pipeline Products & Ongoing Clinical Trials Overview 118

5.58 Group K Diagnostics Company Overview 119

5.58.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 119

5.59 Guangzhou Wondfo Biotech Co Ltd Company Overview 120

5.59.1 Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 120

5.60 HA TECH Pty Ltd Company Overview 122

5.60.1 HA TECH Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 122

5.61 HeatFlow Technologies Inc Company Overview 124

5.61.1 HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 124

5.62 Identifysensors LLC Company Overview 125

5.62.1 Identifysensors LLC Pipeline Products & Ongoing Clinical Trials Overview 125

5.63 Immunetics Inc Company Overview 126

5.63.1 Immunetics Inc Pipeline Products & Ongoing Clinical Trials Overview 126

5.64 Imperial College London Company Overview 127

5.64.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 127

5.65 Institute for Development Research Company Overview 128

5.65.1 Institute for Development Research Pipeline Products & Ongoing Clinical Trials Overview 128

5.66 Integrated Diagnostics Inc (Inactive) Company Overview 129

5.66.1 Integrated Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 129

5.67 Intelligent Bio Solutions Inc Company Overview 130

5.67.1 Intelligent Bio Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 130

5.68 Intuitive Biosciences Inc Company Overview 131

5.68.1 Intuitive Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 131

5.69 Invex Health Pvt Ltd Company Overview 133

5.69.1 Invex Health Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 133

5.70 IRIS International Inc Company Overview 134

5.70.1 IRIS International Inc Pipeline Products & Ongoing Clinical Trials Overview 134

5.71 Jan Biotech Inc Company Overview 135

5.71.1 Jan Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.72 Jinvator Bio Med GmbH Company Overview 138

5.72.1 Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 138

5.73 Johns Hopkins University Company Overview 139

5.73.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 139

5.74 Labgene Biotech Pvt Ltd Company Overview 141

5.74.1 Labgene Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

5.75 Lynntech Inc Company Overview 142

5.75.1 Lynntech Inc Pipeline Products & Ongoing Clinical Trials Overview 142

5.76 Maxim Biomedical Inc Company Overview 143

5.76.1 Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 143

5.77 MedMira Inc Company Overview 144

5.77.1 MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 144

5.78 MedNostic Technologies, LLC Company Overview 146

5.78.1 MedNostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 146

5.79 Medosome Biotec LLC Company Overview 147

5.79.1 Medosome Biotec LLC Pipeline Products & Ongoing Clinical Trials Overview 147

5.80 Micronics Inc Company Overview 148

5.80.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 148

5.81 Minute Molecular Diagnostics Inc (Inactive) Company Overview 150

5.81.1 Minute Molecular Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 150

5.82 MND Diagnostic LTD Company Overview 151

5.82.1 MND Diagnostic LTD Pipeline Products & Ongoing Clinical Trials Overview 151

5.83 Molbio Diagnostics Pvt Ltd Company Overview 152

5.83.1 Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 152

5.84 MyMD Pharmaceuticals Inc Company Overview 153

5.84.1 MyMD Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 153

5.85 Nanobiosym Inc Company Overview 154

5.85.1 Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 154

5.86 NeuMoDx Molecular Inc Company Overview 155

5.86.1 NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 155

5.87 Newmark Diagnostics LLC Company Overview 156

5.87.1 Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 156

5.88 Northwestern University Company Overview 157

5.88.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 157

5.89 Odyssey Thera, inc. (Inactive) Company Overview 158

5.89.1 Odyssey Thera, inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 158

5.90 Oregon Health & Science University Company Overview 159

5.90.1 Oregon Health & Science University Pipeline Products & Ongoing Clinical Trials Overview 159

5.91 Osel Inc Company Overview 160

5.91.1 Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 160

5.92 Paramedical Srl Company Overview 161

5.92.1 Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 161

5.93 Pathogenica Inc Company Overview 162

5.93.1 Pathogenica Inc Pipeline Products & Ongoing Clinical Trials Overview 162

5.94 PATHseq Diagnostics Inc Company Overview 163

5.94.1 PATHseq Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.95 Penn State College of Medicine Company Overview 164

5.95.1 Penn State College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 164

5.96 Philmedi Co Ltd Company Overview 165

5.96.1 Philmedi Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 165

5.97 PixCell Medical Technologies Ltd Company Overview 166

5.97.1 PixCell Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 166

5.98 Prenetics Ltd Company Overview 167

5.98.1 Prenetics Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

5.99 Purdue University Company Overview 168

5.99.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 168

5.100 QuantuMDx Group Ltd Company Overview 169

5.100.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 169

5.101 Quidel Corp Company Overview 170

5.101.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 170

5.102 Radisens Diagnostics Ltd Company Overview 171

5.102.1 Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 171

5.103 Redbud Labs Inc Company Overview 172

5.103.1 Redbud Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 172

5.104 Rheonix Inc Company Overview 173

5.104.1 Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 173

5.105 Rice University Company Overview 174

5.105.1 Rice University Pipeline Products & Ongoing Clinical Trials Overview 174

5.106 Roche Diagnostics International Ltd Company Overview 175

5.106.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

5.107 SD Biosensor Inc Company Overview 178

5.107.1 SD Biosensor Inc Pipeline Products & Ongoing Clinical Trials Overview 178

5.108 Seattle Children’s Hospital Company Overview 179

5.108.1 Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 179

5.109 Sedia Biosciences Corp Company Overview 180

5.109.1 Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 180

5.110 Seegene Inc Company Overview 182

5.110.1 Seegene Inc Pipeline Products & Ongoing Clinical Trials Overview 182

5.111 Sensible Diagnostics Inc Company Overview 183

5.111.1 Sensible Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 183

5.112 Senzo Inc Company Overview 184

5.112.1 Senzo Inc Pipeline Products & Ongoing Clinical Trials Overview 184

5.113 Shenzhen New Industries Biomedical Engineering Co Ltd Company Overview 185

5.113.1 Shenzhen New Industries Biomedical Engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 185

5.114 Siemens Healthineers AG Company Overview 186

5.114.1 Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 186

5.115 Stanford University Company Overview 187

5.115.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 187

5.116 Syamala Srinivasa Life Sciences Pvt. Ltd Company Overview 188

5.116.1 Syamala Srinivasa Life Sciences Pvt. Ltd Pipeline Products & Ongoing Clinical Trials Overview 188

5.117 Taizhou ZECEN Biotech Co Ltd Company Overview 189

5.117.1 Taizhou ZECEN Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 189

5.118 TBG Diagnostics Ltd Company Overview 190

5.118.1 TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 190

5.119 TheoremDx Inc Company Overview 191

5.119.1 TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 191

5.120 TheraDiag SA Company Overview 192

5.120.1 TheraDiag SA Pipeline Products & Ongoing Clinical Trials Overview 192

5.121 Trinity Biotech Plc Company Overview 194

5.121.1 Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 194

5.122 University of California San Diego Company Overview 196

5.122.1 University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 196

5.123 University of Connecticut Company Overview 197

5.123.1 University of Connecticut Pipeline Products & Ongoing Clinical Trials Overview 197

5.124 University of Michigan Company Overview 198

5.124.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 198

5.125 University of Minnesota Company Overview 199

5.125.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 199

5.126 University of the Philippines Manila Company Overview 200

5.126.1 University of the Philippines Manila Pipeline Products & Ongoing Clinical Trials Overview 200

5.127 University of the Western Cape Company Overview 202

5.127.1 University of the Western Cape Pipeline Products & Ongoing Clinical Trials Overview 202

5.128 University of Washington Company Overview 203

5.128.1 University of Washington Pipeline Products & Ongoing Clinical Trials Overview 203

5.129 UrSure Inc Company Overview 205

5.129.1 UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 205

5.130 Ustar Biotechnologies (Hangzhou) Ltd Company Overview 206

5.130.1 Ustar Biotechnologies (Hangzhou) Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

5.131 VEGA Ltd Company Overview 207

5.131.1 VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 207

5.132 Viravaxx AG Company Overview 208

5.132.1 Viravaxx AG Pipeline Products & Ongoing Clinical Trials Overview 208

5.133 Virax Biolabs Group Ltd Company Overview 209

5.133.1 Virax Biolabs Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 209

5.134 Wave 80 Biosciences Inc Company Overview 210

5.134.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 210

5.135 Yaathum Biotech Pvt Ltd Company Overview 212

5.135.1 Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 212

6 Human Immunodeficiency Virus (HIV) Tests- Recent Developments 213

6.1 Feb 07, 2024: Evotec Biologics Expands Development and Manufacturing Agreement with ABL for Broadly Neutralising Antibodies Against HIV 213

6.2 Dec 27, 2023: Trinity Biotech Announces It Has Begun Shipments of Its New HIV Screening Test, TrinScreen HIV to Kenya 213

6.3 Dec 26, 2023: MedMira Receives 510(k) Clearance for Reveal G4 Rapid HIV-1/2 Antibody Test 214

6.4 Nov 22, 2023: Biolytical Laboratories Donates Tests To Help Boost International Testing Access Ahead of International Testing Week 214

6.5 Nov 15, 2023: FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with At-Home Sample Collection 215

6.6 Oct 10, 2023: Trinity Biotech Welcomes the Decision of the High Court of Kenya to Strike Out the Applications to Prevent the Procurement of Trinscreen HIV by the Kenyan Ministry of Health 216

6.7 Sep 27, 2023: Update on MedMira’s Regulatory Path in Canada and the USA 216

6.8 Aug 10, 2023: Bio-Rad Laboratories Receives 510(k) Clearance for Access HIV Combo Assay 217

6.9 Jun 21, 2023: INVEX Health Develops Oral Fluid-based HIV Self-Test 217

6.10 Jun 14, 2023: Atomo and Newfoundland Sign Agreement for HIV Testing in Europe 218

6.11 May 01, 2023: Gilead sciences announces launch of Asia pacific rainbow grant 2023 218

6.12 Apr 26, 2023: George Washington University Hosting Webinar on HIV Testing and Screening Guidelines 219

6.13 Apr 21, 2023: Roche Diagnostics receives additional 510(k) clearance for Elecsys HIV Duo 219

6.14 Mar 27, 2023: Roche Diagnostics and ABL Diagnostics enter into an Exclusive Distribution Agreement in South Africa 220

6.15 Mar 22, 2023: Trinity Biotech welcomes TrinScreen HIV’s inclusion in the New Kenyan HIV Testing Algorithm 220

6.16 Mar 02, 2023: UConn Researcher Develops Simple, Affordable HIV Testing Device 221

6.17 Feb 28, 2023: Significant purchase order for HIV self-tests for Europe 221

7 Appendix 223

7.1 Methodology 223

7.2 About GlobalData 226

7.3 Contact Us 226

7.4 Disclaimer 226

Table

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 20

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Segment 21

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Territory 22

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Regulatory Path 24

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Estimated Approval Date 25

Human Immunodeficiency Virus (HIV) Tests – Ongoing Clinical Trials 26

Human Immunodeficiency Virus (HIV) Tests Companies – Pipeline Products by Stage of Development 27

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 32

Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 37

Urine Tenofovir Rapid Assay – Product Status 37

Urine Tenofovir Rapid Assay – Product Description 37

Abbott Diagnostics – Ongoing Clinical Trials Overview 38

Urine Tenofovir Rapid Assay – Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) 39

Accelevir Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 40

Diagnostic Test – Latent HIV-1 Virus – Product Status 40

Diagnostic Test – Latent HIV-1 Virus – Product Description 40

HIV Persistent Proviruses Transcriptional Activity Detection Test – Product Status 41

HIV Persistent Proviruses Transcriptional Activity Detection Test – Product Description 41

HIV Residual Viremia Assay – Product Status 41

HIV Residual Viremia Assay – Product Description 42

HIV-1 EnvLRS Assay – Product Status 42

HIV-1 EnvLRS Assay – Product Description 42

Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Pandaa HIV6 – Product Status 43

Pandaa HIV6 – Product Description 43

PANDAA HIVDR Minor Variants – Product Status 44

PANDAA HIVDR Minor Variants – Product Description 44

PANDAA HIVDR PI+ – Product Status 44

PANDAA HIVDR PI+ – Product Description 45

PANDAA HIVDR RTI – Product Status 45

PANDAA HIVDR RTI – Product Description 45

Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 46

AIMS System – HIV-1 Test – Product Status 46

AIMS System – HIV-1 Test – Product Description 46

AtheNA Multi-Lyte System – HIV-1 Test – Product Status 47

AtheNA Multi-Lyte System – HIV-1 Test – Product Description 47

Allied Innovative Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 48

HIV p24 Antigen ELISA – Product Status 48

HIV p24 Antigen ELISA – Product Description 48

Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Point-Of-Care Test – HIV Infection – Product Status 49

Point-Of-Care Test – HIV Infection – Product Description 49

Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

Atomo HIV Self Test – Product Status 50

Atomo HIV Self Test – Product Description 51

AtomoRapid HIV – Product Status 51

AtomoRapid HIV – Product Description 51

Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 52

Viral Protein Antibody Test – Non-HIV AIDS – Product Status 52

Viral Protein Antibody Test – Non-HIV AIDS – Product Description 52

Ayanda Biosystems SA (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 53

DETECTHIV – Product Status 53

DETECTHIV – Product Description 53

Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Point-of-Care Diagnostic Test – HIV – Product Status 54

Point-of-Care Diagnostic Test – HIV – Product Description 54

BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Mobile RDT Reader – HIV1/2 Test – Product Status 55

Mobile RDT Reader – HIV1/2 Test – Product Description 55

Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

Urine Based Rapid HIV Test – Product Status 56

Urine Based Rapid HIV Test – Product Description 56

Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 57

Atlas io System – HIV Assay – Product Status 57

Atlas io System – HIV Assay – Product Description 57

Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 58

Digital Strip Reader – HIV Test – Product Status 58

Digital Strip Reader – HIV Test – Product Description 58

Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 59

Idylla Viral Load Assay – HIV – Product Status 59

Idylla Viral Load Assay – HIV – Product Description 59

BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 60

IsoAmp HIV-1 Quantitative Assay – Product Status 60

IsoAmp HIV-1 Quantitative Assay – Product Description 60

Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 61

BIO-FLASH HIV-1+2 Ag/Ab Assay – Product Status 61

BIO-FLASH HIV-1+2 Ag/Ab Assay – Product Description 61

Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 62

Diagnostic Test – HIV – Product Status 62

Diagnostic Test – HIV – Product Description 62

IOBS – HIV Diagnostic Test – Product Status 63

IOBS – HIV Diagnostic Test – Product Description 63

Blackfly Investments LLC Pipeline Products & Ongoing Clinical Trials Overview 64

Molecular RNA Test – HIV – Product Status 64

Molecular RNA Test – HIV – Product Description 64

Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 65

HIV POC Test – Product Status 65

HIV POC Test – Product Description 65

Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 66

Aware 2 HIV-1/2 – Product Status 66

Aware 2 HIV-1/2 – Product Description 66

Second Generation Incidence Test – HIV – Product Status 67

Second Generation Incidence Test – HIV – Product Description 67

Cell Microsystems Inc Pipeline Products & Ongoing Clinical Trials Overview 68

Diagnostic Assay – Latent HIV Reservoir – Product Status 68

Diagnostic Assay – Latent HIV Reservoir – Product Description 68

CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 69

Diagnostic Test – HIV – Product Status 69

Diagnostic Test – HIV – Product Description 69

Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 70

Point-Of-Care Diagnostic Test – HIV-1 – Product Status 70

Point-Of-Care Diagnostic Test – HIV-1 – Product Description 70

Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 71

GeneXpert Omni – HIV-1 Qualitative Test – Product Status 71

GeneXpert Omni – HIV-1 Qualitative Test – Product Description 71

GeneXpert Omni – HIV-1 Viral Load Test – Product Status 72

GeneXpert Omni – HIV-1 Viral Load Test – Product Description 72

Xpert HIV Quant Assay – Product Status 72

Xpert HIV Quant Assay – Product Description 73

Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 74

DPP HIV Ag-Ab Assay – Product Status 74

DPP HIV Ag-Ab Assay – Product Description 74

DPP HIV-Syphilis Assay – Product Status 75

DPP HIV-Syphilis Assay – Product Description 75

Chembio Diagnostic Systems Inc – Ongoing Clinical Trials Overview 76

DPP HIV-Syphilis Assay – Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore 77

CHIP Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 78

ExoTENPO – HIV Assay – Product Status 78

ExoTENPO – HIV Assay – Product Description 78

ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 79

CD4 Assay – HIV – Product Status 79

CD4 Assay – HIV – Product Description 79

Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 80

HIV RNA Real-time PCR Kit – Product Status 80

HIV RNA Real-time PCR Kit – Product Description 80

Conrad Pipeline Products & Ongoing Clinical Trials Overview 81

Biomarker – HIV Acquisition – Product Status 81

Biomarker – HIV Acquisition – Product Description 81

Cornell University Pipeline Products & Ongoing Clinical Trials Overview 82

Diagnostic Test – Acute HIV Infection – Product Status 82

Diagnostic Test – Acute HIV Infection – Product Description 82

CoSara Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

Viral Load Test – HIV – Product Status 83

Viral Load Test – HIV – Product Description 83

CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 84

TARApen Test – Product Status 84

TARApen Test – Product Description 84

Cue Inc Pipeline Products & Ongoing Clinical Trials Overview 85

Cue HIV Viral Load Test – Product Status 85

Cue HIV Viral Load Test – Product Description 85

Cupid Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

HIV 1/2 Ab Test – Product Status 86

HIV 1/2 Ab Test – Product Description 86

Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87

Aspect – HIV Viral Load Test – Product Status 87

Aspect – HIV Viral Load Test – Product Description 87

Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 88

Paper-Based Microfluidic Device – HIV – Product Status 88

Paper-Based Microfluidic Device – HIV – Product Description 88

Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

SAMBA – HIV-1 Viral Load Assay – Product Status 89

SAMBA – HIV-1 Viral Load Assay – Product Description 89

SAMBA VL – Product Status 90

SAMBA VL – Product Description 90

SAS – HIV Assay – Product Status 90

SAS – HIV Assay – Product Description 91

Diagnostics for the Real World Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

SAMBA III – Product Status 92

SAMBA III – Product Description 92

Discidium Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 93

Screening Test – HIV Drug Resistance – Product Status 93

Screening Test – HIV Drug Resistance – Product Description 93

DNAE Group Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

USB Stick-Based HIV Test – Product Status 94

USB Stick-Based HIV Test – Product Description 94

Drexel University Pipeline Products & Ongoing Clinical Trials Overview 95

HAND Assay – HIV – Product Status 95

HAND Assay – HIV – Product Description 95

Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 96

ADAP HIV Assay – Product Status 96

ADAP HIV Assay – Product Description 96

Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 97

Rapid Immunoassay Test – HIV 1 And 2 – Product Status 97

Rapid Immunoassay Test – HIV 1 And 2 – Product Description 97

Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 98

AmpiProbe HIV Viral Load Assay – Product Status 98

AmpiProbe HIV Viral Load Assay – Product Description 98

Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 99

Epinex G1A – Neo-natal HIV Test – Product Status 99

Epinex G1A – Neo-natal HIV Test – Product Description 99

ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 100

BART – HIV Viral Load Test – Product Status 100

BART – HIV Viral Load Test – Product Description 100

Early Infant Diagnostic Assay – HIV – Product Status 101

Early Infant Diagnostic Assay – HIV – Product Description 101

Next Generation HIV Viral Load Monitoring Test – Product Status 101

Next Generation HIV Viral Load Monitoring Test – Product Description 102

Eurobio Scientific SA Pipeline Products & Ongoing Clinical Trials Overview 103

CO-3S Companion Diagnostic Assay – Product Status 103

CO-3S Companion Diagnostic Assay – Product Description 103

DIAG-3S Diagnostic Assay – Product Status 104

DIAG-3S Diagnostic Assay – Product Description 104

Disease Evolution Predictive Test – AIDS – Product Status 104

Disease Evolution Predictive Test – AIDS – Product Description 105

Fast Track Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

FTD HIV Assay – Product Status 106

FTD HIV Assay – Product Description 106

Fluxergy LLC Pipeline Products & Ongoing Clinical Trials Overview 107

Diagnostic Test – HIV-1 Viral Load – Product Status 107

Diagnostic Test – HIV-1 Viral Load – Product Description 107

Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 108

Lumipulse G – HIV 1/2 Assay Kit – Product Status 108

Lumipulse G – HIV 1/2 Assay Kit – Product Description 108

Lumipulse G – HIV-1p24 Assay Kit – Product Status 109

Lumipulse G – HIV-1p24 Assay Kit – Product Description 109

Lumipulse G – HIVAg/Ab Assay Kit – Product Status 109

Lumipulse G – HIVAg/Ab Assay Kit – Product Description 109

G Medical Health and Wellness Pipeline Products & Ongoing Clinical Trials Overview 111

HIV Test – Product Status 111

HIV Test – Product Description 111

GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 112

Point-Of-Care Diagnostic Test – HIV – Product Status 112

Point-Of-Care Diagnostic Test – HIV – Product Description 112

genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 113

Genedrive – HIV Assay – Product Status 113

Genedrive – HIV Assay – Product Description 113

Genome Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

CD4 Real Time PCR Kit – Product Status 114

CD4 Real Time PCR Kit – Product Description 114

CD8 Real Time PCR Kit – Product Status 115

CD8 Real Time PCR Kit – Product Description 115

HIV-2 Real Time PCR Kit – Product Status 115

HIV-2 Real Time PCR Kit – Product Description 115

Multiplex CD4/CD8 Real Time PCR Kit – HIV – Product Status 116

Multiplex CD4/CD8 Real Time PCR Kit – HIV – Product Description 116

Giner Inc Pipeline Products & Ongoing Clinical Trials Overview 117

Point-of-Care Assay – Antiretroviral HIV Therapy – Product Status 117

Point-of-Care Assay – Antiretroviral HIV Therapy – Product Description 117

Goodgene Inc Pipeline Products & Ongoing Clinical Trials Overview 118

HIV-1/2 Multiplex RT-PCR Kit – Product Status 118

HIV-1/2 Multiplex RT-PCR Kit – Product Description 118

Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 119

KromaHealth Kit – HIV Ab/Ag – Product Status 119

KromaHealth Kit – HIV Ab/Ag – Product Description 119

Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 120

Accre Diagnostic Assay – HIV Combo – Product Status 120

Accre Diagnostic Assay – HIV Combo – Product Description 120

HA TECH Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 122

HIV 1&2 Rapid Antibody Test Kit – Product Status 122

HIV 1&2 Rapid Antibody Test Kit – Product Description 122

Human Immunodeficiency Virus Type 1 RT-PCR Detection Kit – Product Status 122

Human Immunodeficiency Virus Type 1 RT-PCR Detection Kit – Product Description 123

HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 124

HF-PCR Point Of Care HIV Viral Load Assay – Product Status 124

HF-PCR Point Of Care HIV Viral Load Assay – Product Description 124

Identifysensors LLC Pipeline Products & Ongoing Clinical Trials Overview 125

Check4-HIV – Product Status 125

Check4-HIV – Product Description 125

Immunetics Inc Pipeline Products & Ongoing Clinical Trials Overview 126

Diagnostic Test – HIV – Product Status 126

Diagnostic Test – HIV – Product Description 126

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 127

Diagnostic Assay – HIV – Product Status 127

Diagnostic Assay – HIV – Product Description 127

Institute for Development Research Pipeline Products & Ongoing Clinical Trials Overview 128

RT-qPCR HIV-1 Viral Load Assay – Product Status 128

RT-qPCR HIV-1 Viral Load Assay – Product Description 128

Integrated Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 129

HIV Diagnostic Test – Product Status 129

HIV Diagnostic Test – Product Description 129

Intelligent Bio Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 130

Diagnostic Test – HIV Infection – Product Status 130

Diagnostic Test – HIV Infection – Product Description 130

Intuitive Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 131

EV-HIV Assay – Product Status 131

EV-HIV Assay – Product Description 131

IRIS-HIV Assay – Product Status 132

IRIS-HIV Assay – Product Description 132

Invex Health Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 133

Oral Fluid-Based HIV Self-Test – Product Status 133

Oral Fluid-Based HIV Self-Test – Product Description 133

IRIS International Inc Pipeline Products & Ongoing Clinical Trials Overview 134

NADIA – HIV – Product Status 134

NADIA – HIV – Product Description 134

Jan Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 135

HIV Reservoir RNAamp Assay – Product Status 135

HIV Reservoir RNAamp Assay – Product Description 135

Point-Of-Care Oral Diagnostic Test – HIV – Product Status 135

Point-Of-Care Oral Diagnostic Test – HIV – Product Description 136

Sequence-Based RNA Fluorescence Assay – HIV – Product Status 136

Sequence-Based RNA Fluorescence Assay – HIV – Product Description 136

Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 138

nanoGold Test – Product Status 138

nanoGold Test – Product Description 138

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 139

Magnetic Nanowire – Product Status 139

Magnetic Nanowire – Product Description 139

Point-Of-Care Test – Pediatric HIV – Product Status 139

Point-Of-Care Test – Pediatric HIV – Product Description 140

Labgene Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

RT-PCR Based Diagnostic Test – HIV – Product Status 141

RT-PCR Based Diagnostic Test – HIV – Product Description 141

Lynntech Inc Pipeline Products & Ongoing Clinical Trials Overview 142

Rapid Point-of-Care HIV Viral Load Test – Product Status 142

Rapid Point-of-Care HIV Viral Load Test – Product Description 142

Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 143

Multiplex Lateral Flow Immunoassay – Product Status 143

Multiplex Lateral Flow Immunoassay – Product Description 143

MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 144

MedDuo Dual HIV Ab/Ag Test – Product Status 144

MedDuo Dual HIV Ab/Ag Test – Product Description 144

Reveal G4 Rapid HIV-1 Antibody Test – Product Status 145

Reveal G4 Rapid HIV-1 Antibody Test – Product Description 145

MedNostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 146

MedNetic HIV Immunoassay – Product Status 146

MedNetic HIV Immunoassay – Product Description 146

Medosome Biotec LLC Pipeline Products & Ongoing Clinical Trials Overview 147

HIV Drug Resistance Assay – Product Status 147

HIV Drug Resistance Assay – Product Description 147

Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 148

MTCT – HIV Assay – Product Status 148

MTCT – HIV Assay – Product Description 148

PanNAT – HIV Assay – Product Status 149

PanNAT – HIV Assay – Product Description 149

Minute Molecular Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 150

DASH HIV Viral Load Test – Product Status 150

DASH HIV Viral Load Test – Product Description 150

MND Diagnostic LTD Pipeline Products & Ongoing Clinical Trials Overview 151

Diagnostic Kit – AIDS – Product Status 151

Diagnostic Kit – AIDS – Product Description 151

Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 152

Truenat HIV-1/2 Assay – Product Status 152

Truenat HIV-1/2 Assay – Product Description 152

MyMD Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 153

PIFA HIV 1+2 Rapid Assay – Product Status 153

PIFA HIV 1+2 Rapid Assay – Product Description 153

Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 154

Gene-Radar – HIV Viral Load Assay – Product Status 154

Gene-Radar – HIV Viral Load Assay – Product Description 154

NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 155

NeuMoDx HIV Assay – Product Status 155

NeuMoDx HIV Assay – Product Description 155

Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 156

Point-Of-Care Diagnostic Test – HIV – Product Status 156

Point-Of-Care Diagnostic Test – HIV – Product Description 156

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 157

Infant HIV Test – Product Status 157

Infant HIV Test – Product Description 157

Odyssey Thera, inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 158

Diagnostic Assay – HIV Infection – Product Status 158

Diagnostic Assay – HIV Infection – Product Description 158

Oregon Health & Science University Pipeline Products & Ongoing Clinical Trials Overview 159

Biomarker Test – HIV – Product Status 159

Biomarker Test – HIV – Product Description 159

Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 160

Point-Of-Care Diagnostic Test – HIV-1 Infection – Product Status 160

Point-Of-Care Diagnostic Test – HIV-1 Infection – Product Description 160

Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 161

PKL PPC 960 – HIV Ag/Ab – Product Status 161

PKL PPC 960 – HIV Ag/Ab – Product Description 161

Pathogenica Inc Pipeline Products & Ongoing Clinical Trials Overview 162

DxSeq – HIV Test – Product Status 162

DxSeq – HIV Test – Product Description 162

PATHseq Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 163

Diagnostic Assay – HIV – Product Status 163

Diagnostic Assay – HIV – Product Description 163

Penn State College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 164

Digital Assay – HIV – Product Status 164

Digital Assay – HIV – Product Description 164

Philmedi Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 165

HIV POC Molecular Diagnostic Test – Product Status 165

HIV POC Molecular Diagnostic Test – Product Description 165

PixCell Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 166

Diagnostic Test – CD4+ Lymphocytes – Product Status 166

Diagnostic Test – CD4+ Lymphocytes – Product Description 166

Prenetics Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

30-Minute Home Test Kit – HIV – Product Status 167

30-Minute Home Test Kit – HIV – Product Description 167

Purdue University Pipeline Products & Ongoing Clinical Trials Overview 168

Diagnostic Test – HIV Infection – Product Status 168

Diagnostic Test – HIV Infection – Product Description 168

QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 169

Q-POC – HIV Assay – Product Status 169

Q-POC – HIV Assay – Product Description 169

Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 170

Savanna – HIV VL Assay – Product Status 170

Savanna – HIV VL Assay – Product Description 170

Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 171

Diagnostic Panel – HIV – Product Status 171

Diagnostic Panel – HIV – Product Description 171

Redbud Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 172

MXR Cartridge – HIV-1 Viral Load – Product Status 172

MXR Cartridge – HIV-1 Viral Load – Product Description 172

Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 173

Rheonix CARD – HIV Assay – Product Status 173

Rheonix CARD – HIV Assay – Product Description 173

Rice University Pipeline Products & Ongoing Clinical Trials Overview 174

Programmable Bio-Nano-Chip – HIV/AIDS – Product Status 174

Programmable Bio-Nano-Chip – HIV/AIDS – Product Description 174

Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

Cobas 4000 Analyzer Series With c 311 Module – HIV Combi PT Assay – Product Status 175

Cobas 4000 Analyzer Series With c 311 Module – HIV Combi PT Assay – Product Description 175

Cobas 5800 – HIV-1/HIV-2 Qualitative Test – Product Status 176

Cobas 5800 – HIV-1/HIV-2 Qualitative Test – Product Description 176

Integrated Modular Analytics – HIV Combi Test – Product Status 176

Integrated Modular Analytics – HIV Combi Test – Product Description 177

Liat HIV-1 Viral Load Assay – Product Status 177

Liat HIV-1 Viral Load Assay – Product Description 177

SD Biosensor Inc Pipeline Products & Ongoing Clinical Trials Overview 178

STANDARD M10 HIV-1 VL – Product Status 178

STANDARD M10 HIV-1 VL – Product Description 178

Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 179

Diagnostic Test – HIV – Product Status 179

Diagnostic Test – HIV – Product Description 179

Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 180

Asanté HIV-1/2 Oral Self-Test – Product Status 180

Asanté HIV-1/2 Oral Self-Test – Product Description 180

Asanté Rapid HIV-1 Recency (or Incidence) Assay – Product Status 180

Asanté Rapid HIV-1 Recency (or Incidence) Assay – Product Description 181

Seegene Inc Pipeline Products & Ongoing Clinical Trials Overview 182

Allplex – HIV Q Assay – Product Status 182

Allplex – HIV Q Assay – Product Description 182

Sensible Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 183

Point-Of-Care Test – HIV – Product Status 183

Point-Of-Care Test – HIV – Product Description 183

Senzo Inc Pipeline Products & Ongoing Clinical Trials Overview 184

Amplified Lateral Flow Test – HIV – Product Status 184

Amplified Lateral Flow Test – HIV – Product Description 184

Shenzhen New Industries Biomedical Engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 185

MAGLUMI 2000 – HIV – Product Status 185

MAGLUMI 2000 – HIV – Product Description 185

Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 186

Selzentry Companion Diagnostic Test – Product Status 186

Selzentry Companion Diagnostic Test – Product Description 186

Stanford University Pipeline Products & Ongoing Clinical Trials Overview 187

Ultra-Sensitive Test – HIV – Product Status 187

Ultra-Sensitive Test – HIV – Product Description 187

Syamala Srinivasa Life Sciences Pvt. Ltd Pipeline Products & Ongoing Clinical Trials Overview 188

Human Immunodeficiency Virus Test – Product Status 188

Human Immunodeficiency Virus Test – Product Description 188

Taizhou ZECEN Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 189

HIV Ag/Ab Detection Kit – Product Status 189

HIV Ag/Ab Detection Kit – Product Description 189

TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 190

Diagnostic Assay – HIV – Product Status 190

Diagnostic Assay – HIV – Product Description 190

TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 191

Rapid Diagnostic Test – HIV – Product Status 191

Rapid Diagnostic Test – HIV – Product Description 191

TheraDiag SA Pipeline Products & Ongoing Clinical Trials Overview 192

Companion Diagnostic Assay – HIV/AIDS – Product Status 192

Companion Diagnostic Assay – HIV/AIDS – Product Description 192

HIV Tropism Kit – Product Status 193

HIV Tropism Kit – Product Description 193

Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 194

HIV Self-Test Kit – Product Status 194

HIV Self-Test Kit – Product Description 194

TrinScreen HIV – Product Status 195

TrinScreen HIV – Product Description 195

University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 196

Diagnostic Test – HIV – Product Status 196

Diagnostic Test – HIV – Product Description 196

University of Connecticut Pipeline Products & Ongoing Clinical Trials Overview 197

AIOD-CRISPR Assay – HIV – Product Status 197

AIOD-CRISPR Assay – HIV – Product Description 197

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 198

Microscale Western Blot Immunoassay – HIV – Product Status 198

Microscale Western Blot Immunoassay – HIV – Product Description 198

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 199

Lateral Flow Assay – HIV-1 – Product Status 199

Lateral Flow Assay – HIV-1 – Product Description 199

University of the Philippines Manila Pipeline Products & Ongoing Clinical Trials Overview 200

Paper-Based Diagnostic Kit – HIV Drug Resistance – Product Status 200

Paper-Based Diagnostic Kit – HIV Drug Resistance – Product Description 200

Rapid Diagnostic Test – Lamivudine Resistance – Product Status 200

Rapid Diagnostic Test – Lamivudine Resistance – Product Description 201

University of the Western Cape Pipeline Products & Ongoing Clinical Trials Overview 202

Point of Care Test – HIV – Product Status 202

Point of Care Test – HIV – Product Description 202

University of Washington Pipeline Products & Ongoing Clinical Trials Overview 203

Diagnostic Test – HIV – Product Status 203

Diagnostic Test – HIV – Product Description 203

Electrokinetic Paper Based-Nucleic Acid Amplification Assay – Product Status 203

Electrokinetic Paper Based-Nucleic Acid Amplification Assay – Product Description 204

UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 205

PrEP Adherence Test – HIV – Product Status 205

PrEP Adherence Test – HIV – Product Description 205

Ustar Biotechnologies (Hangzhou) Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

RT CPA HIV-1 Viral Load Test – Product Status 206

RT CPA HIV-1 Viral Load Test – Product Description 206

VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 207

Diagnostic Assay – HIV – Product Status 207

Diagnostic Assay – HIV – Product Description 207

Viravaxx AG Pipeline Products & Ongoing Clinical Trials Overview 208

Companion Diagnostic Assay – HIV – Product Status 208

Companion Diagnostic Assay – HIV – Product Description 208

Virax Biolabs Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 209

Virax Immune T-Cell Test – HIV – Product Status 209

Virax Immune T-Cell Test – HIV – Product Description 209

Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 210

EOSCAPE HIV-1 RNA Viral Load Test – Product Status 210

EOSCAPE HIV-1 RNA Viral Load Test – Product Description 210

EOSCAPE-HIV RNA PLUS – Product Status 211

EOSCAPE-HIV RNA PLUS – Product Description 211

Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 212

Rapid Diagnostic Test – HIV – Product Status 212

Rapid Diagnostic Test – HIV – Product Description 212

Glossary 225

Figures

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 20

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Segment 21

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Territory 22

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Regulatory Path 24

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Estimated Approval Date 25

Human Immunodeficiency Virus (HIV) Tests – Ongoing Clinical Trials 26

Frequently asked questions

Human Immunodeficiency Virus (HIV) Tests Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies thematic reports
Currency USD
$4,000

Can be used by individual purchaser only

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Human Immunodeficiency Virus (HIV) Tests Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies was curated by the best experts in the industry and we are confident about its unique quality. However, we want you to make the most beneficial decision for your business, so we offer free sample pages to help you:

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