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

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Human Immunodeficiency Virus (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. HIV type I detection tests include Serology, PCR, Branched DNA, NAT, and CD4 tests. One unit refers to one test.

The human immunodeficiency virus (HIV) tests pipeline market research report provides comprehensive information about the Human immunodeficiency virus (HIV) tests pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Segments ·       HIV Point of care (POC) Tests

·       HIV Nucleic Acid Amplification Tests (NAATs)

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

·       CD4 Count Tests

Key Territories ·       United States

·       Europe

·       India

·       China

·       Japan

·       South Africa

·       South Korea

·       Russia

·       Singapore

·       Israel

·       Others

Key Regulatory Paths ·       PMA

·       CE-IVD

·       ICAC

·       510(k)

·       NMPA

·       Shonin

·       CE

·       Others

Leading Companies ·       Abbott Rapid Diagnostics GmbH

·       BBB Technologies Inc

·       Calypte Biomedical Corporation

·       Diagnostics For All Inc

·       Others

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Human Immunodeficiency Virus (HIV) Tests Pipeline Market by Segments

The key segments in the human immunodeficiency virus (HIV) tests market are HIV Point of care (POC) Tests, HIV Nucleic Acid Amplification Tests (NAATs), HIV Enzyme Immuno Assay/Enzyme Linked Immunosorbent Assay (EIA/ELISA) Tests, and CD4 Count Tests. As of July 2023, the HIV Point of care (POC) Tests segment had the highest number of pipeline products.

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Analysis by Segments, 2023 (%)

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Analysis by Segments, 2023 (%)

For more segment insights into the human immunodeficiency virus (HIV) tests pipeline market, download a free report sample

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Segmentation by Territories

Some of the key territories in the human immunodeficiency virus (HIV) tests market are the United States, Europe, India, China, Japan, South Africa, South Korea, and Russia among others. As of July 2023, the US had the highest number of pipeline products.

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Analysis by Territories, 2023 (%)

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Analysis by Territories, 2023 (%)

For more territory insights into the human immunodeficiency virus (HIV) tests pipeline market, download a free report sample

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Segmentation by Regulatory Paths

Some of the key regulatory paths in the Human immunodeficiency virus (HIV) tests pipeline market are PMA, CE-IVD, ICAC, 510(k), NMPA, Shonin, CE, TGA, NIFDS, and CLIA among others. As of July 2023, PMA was the most followed pathway for pipeline products.

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

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

For more regulatory path insights into the human immunodeficiency virus (HIV) tests pipeline market, download a free report sample

Human immunodeficiency virus (HIV) tests Pipeline Market – Competitive Landscape

Some of the key companies in the Human immunodeficiency virus (HIV) tests pipeline market are Abbott Rapid Diagnostics GmbH, BBB Technologies Inc, Calypte Biomedical Corporation, and Diagnostics For All Inc among others.

Abbott Rapid Diagnostics GmbH: Abbott Rapid Diagnostics GmbH is a medical technology manufacturing company. It is headquartered in Jena, Germany. The company offers Urine Tenofovir Rapid Assay (UTRA). It is a rapid, point-of-care assay intended for medication adherence monitoring. It is designed to detect adherence to the antiretroviral medication Tenofovir (TDF) in the patient’s urine sample.

BBB Technologies Inc: BBB Technologies Inc (BBB Tech) is development-stage medical technology company that develops medical devices and applications that facilitate the early diagnosis of metabolic and cardiovascular disorders. It discovers and develops single-drop and mobile integrated diagnostic tools for blood testing. Its lead product Elemark, is an android-powered real-time mobile blood diagnostic device that can check multiple parameters for the management of chronic diseases such as cholesterol, blood sugar, and heart disease. BBB Tech’s ResearchLine platform facilitates the collection of health data from wearable devices and provides analysis. The company has its operations in the US, South Korea, and China. BBB Tech is headquartered in Mountain View, California, the US.

Leading Human Immunodeficiency Virus (HIV) Tests Companies, 2023

Leading Human Immunodeficiency Virus (HIV) Tests Companies, 2023

For more company insights into the human immunodeficiency virus (HIV) tests pipeline market, download a free report sample

Segments Covered in the Report

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Segments Outlook

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

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Territories Outlook

  • United States
  • Europe
  • India
  • China
  • Japan
  • South Africa
  • South Korea
  • Russia
  • Singapore
  • Israel
  • Others

Human Immunodeficiency Virus (HIV) Tests Pipeline Market Regulatory Paths Outlook

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

Scope

This report provides:

  • Extensive coverage of the Human immunodeficiency virus (HIV) tests under development.
  • Details of major pipeline products which includes product description, licensing and collaboration details, and other developmental activities.
  • Reviews of the major players involved in the development of Human immunodeficiency virus (HIV) tests and lists of 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 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 portfolios and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Human immunodeficiency virus (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.
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date

Abbott Rapid Diagnostics GmbH
Accelevir Diagnostics LLC
Aldatu Biosciences Inc
Alere Inc
Allied Innovative Systems, LLC
Altratech Ltd
Atomo Diagnostics Ltd
Autoimmune Technologies LLC
Ayanda Biosystems SA (Inactive)
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
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
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
Maxim Biomedical Inc
MedMira Inc
MedNostic Technologies, LLC
Medosome Biotec LLC
Micronics Inc
Minute Molecular Diagnostics Inc
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
PixCell Medical Technologies Ltd
Prenetics Ltd
Purdue University
QuantuMDx Group Ltd
Quidel Corp
Radisens Diagnostics Ltd
Rheonix Inc
Rice University
Roche Diagnostics International Ltd
Seattle Children's Hospital
Sedia Biosciences Corp
Seegene 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 Washington
UrSure Inc
Ustar Biotechnologies (Hangzhou) Ltd.
VEGA Ltd
Wave 80 Biosciences Inc
Yaathum Biotech Pvt Ltd

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 8

|1.2 List of Figures 17

2 Introduction 18

2.1 Human Immunodeficiency Virus (HIV) Tests Overview 18

3 Products under Development 19

3.1 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 19

3.2 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Segment 20

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

3.4 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Regulatory Path 23

3.5 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Estimated Approval Date 24

3.6 Human Immunodeficiency Virus (HIV) Tests – Ongoing Clinical Trials 25

4 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products under Development by Companies 26

4.1 Human Immunodeficiency Virus (HIV) Tests Companies – Pipeline Products by Stage of Development 26

4.2 Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 31

5 Human Immunodeficiency Virus (HIV) Tests Companies and Product Overview 35

5.1 Abbott Rapid Diagnostics GmbH Company Overview 35

5.1.1 Abbott Rapid Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 35

5.2 Accelevir Diagnostics LLC Company Overview 38

5.2.1 Accelevir Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 38

5.3 Aldatu Biosciences Inc Company Overview 41

5.3.1 Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.4 Alere Inc Company Overview 44

5.4.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.5 Allied Innovative Systems, LLC Company Overview 46

5.5.1 Allied Innovative Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 46

5.6 Altratech Ltd Company Overview 47

5.6.1 Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

5.7 Atomo Diagnostics Ltd Company Overview 48

5.7.1 Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

5.8 Autoimmune Technologies LLC Company Overview 50

5.8.1 Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 50

5.9 Ayanda Biosystems SA (Inactive) Company Overview 51

5.9.1 Ayanda Biosystems SA (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 51

5.10 BBB Technologies Inc Company Overview 52

5.10.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 52

5.11 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Company Overview 53

5.11.1 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

5.12 Binx Health Inc Company Overview 54

5.12.1 Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.13 Bio-AMD Inc Company Overview 55

5.13.1 Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.14 Biocartis Group NV Company Overview 56

5.14.1 Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 56

5.15 BioHelix Corp Company Overview 57

5.15.1 BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 57

5.16 Biokit SA Company Overview 58

5.16.1 Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 58

5.17 Biomagnetics Diagnostics Corp Company Overview 59

5.17.1 Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 59

5.18 Blackfly Investments LLC Company Overview 61

5.18.1 Blackfly Investments LLC Pipeline Products & Ongoing Clinical Trials Overview 61

5.19 Bluejay Diagnostics Inc Company Overview 62

5.19.1 Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.20 Calypte Biomedical Corporation Company Overview 63

5.20.1 Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 63

5.21 Cell Microsystems Inc Company Overview 66

5.21.1 Cell Microsystems Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.22 CeMines, Inc. (Inactive) Company Overview 67

5.22.1 CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 67

5.23 Centre International de Reference Chantal Biya Company Overview 68

5.23.1 Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 68

5.24 Cepheid Inc Company Overview 69

5.24.1 Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.25 Chembio Diagnostic Systems Inc Company Overview 72

5.25.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.26 CHIP Diagnostics Inc Company Overview 76

5.26.1 CHIP Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 76

5.27 ChipCare Corp Company Overview 77

5.27.1 ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 77

5.28 Co-Diagnostics Inc Company Overview 78

5.28.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.29 Conrad Company Overview 79

5.29.1 Conrad Pipeline Products & Ongoing Clinical Trials Overview 79

5.30 Cornell University Company Overview 80

5.30.1 Cornell University Pipeline Products & Ongoing Clinical Trials Overview 80

5.31 CoSara Diagnostics Pvt Ltd Company Overview 81

5.31.1 CoSara Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 81

5.32 CrossLife Technologies Inc Company Overview 83

5.32.1 CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.33 Cue Inc Company Overview 84

5.33.1 Cue Inc Pipeline Products & Ongoing Clinical Trials Overview 84

5.34 Cupid Ltd Company Overview 85

5.34.1 Cupid Ltd Pipeline Products & Ongoing Clinical Trials Overview 85

5.35 Daktari Diagnostics, Inc. Company Overview 86

5.35.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 86

5.36 Diagnostics For All Inc Company Overview 87

5.36.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.37 Diagnostics for the Real World (Europe) Ltd Company Overview 88

5.37.1 Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 88

5.38 Diagnostics for the Real World Ltd Company Overview 90

5.38.1 Diagnostics for the Real World Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

5.39 Discidium Biosciences LLC Company Overview 91

5.39.1 Discidium Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 91

5.40 DNAE Group Holdings Ltd Company Overview 92

5.40.1 DNAE Group Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

5.41 Enable Biosciences Inc Company Overview 93

5.41.1 Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.42 Endeavor Sciences Inc Company Overview 94

5.42.1 Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.43 Enzo Biochem Inc Company Overview 95

5.43.1 Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 95

5.44 Epinex Diagnostics Inc Company Overview 96

5.44.1 Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.45 ERBA Molecular Ltd Company Overview 97

5.45.1 ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 97

5.46 Eurobio Scientific SA Company Overview 100

5.46.1 Eurobio Scientific SA Pipeline Products & Ongoing Clinical Trials Overview 100

5.47 Fast Track Diagnostics Ltd Company Overview 102

5.47.1 Fast Track Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

5.48 Fluxergy LLC Company Overview 103

5.48.1 Fluxergy LLC Pipeline Products & Ongoing Clinical Trials Overview 103

5.49 Fujirebio Diagnostics Inc Company Overview 104

5.49.1 Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 104

5.50 G Medical Health and Wellness Company Overview 107

5.50.1 G Medical Health and Wellness Pipeline Products & Ongoing Clinical Trials Overview 107

5.51 GAIA Medical Institute LLC Company Overview 108

5.51.1 GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 108

5.52 genedrive plc Company Overview 109

5.52.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 109

5.53 Genome Diagnostics Pvt Ltd Company Overview 110

5.53.1 Genome Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

5.54 Goodgene Inc Company Overview 113

5.54.1 Goodgene Inc Pipeline Products & Ongoing Clinical Trials Overview 113

5.55 Group K Diagnostics Company Overview 114

5.55.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 114

5.56 Guangzhou Wondfo Biotech Co Ltd Company Overview 115

5.56.1 Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 115

5.57 HA TECH Pty Ltd Company Overview 117

5.57.1 HA TECH Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

5.58 HeatFlow Technologies Inc Company Overview 119

5.58.1 HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 119

5.59 Identifysensors LLC Company Overview 120

5.59.1 Identifysensors LLC Pipeline Products & Ongoing Clinical Trials Overview 120

5.60 Immunetics Inc Company Overview 121

5.60.1 Immunetics Inc Pipeline Products & Ongoing Clinical Trials Overview 121

5.61 Imperial College London Company Overview 122

5.61.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 122

5.62 Institute for Development Research Company Overview 123

5.62.1 Institute for Development Research Pipeline Products & Ongoing Clinical Trials Overview 123

5.63 Integrated Diagnostics Inc (Inactive) Company Overview 124

5.63.1 Integrated Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 124

5.64 Intelligent Bio Solutions Inc Company Overview 125

5.64.1 Intelligent Bio Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 125

5.65 Intuitive Biosciences Inc Company Overview 126

5.65.1 Intuitive Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 126

5.66 Invex Health Pvt Ltd Company Overview 127

5.66.1 Invex Health Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 127

5.67 IRIS International Inc Company Overview 128

5.67.1 IRIS International Inc Pipeline Products & Ongoing Clinical Trials Overview 128

5.68 Jan Biotech Inc Company Overview 129

5.68.1 Jan Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 129

5.69 Jinvator Bio Med GmbH Company Overview 132

5.69.1 Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 132

5.70 Johns Hopkins University Company Overview 133

5.70.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 133

5.71 Maxim Biomedical Inc Company Overview 135

5.71.1 Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.72 MedMira Inc Company Overview 136

5.72.1 MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 136

5.73 MedNostic Technologies, LLC Company Overview 138

5.73.1 MedNostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 138

5.74 Medosome Biotec LLC Company Overview 139

5.74.1 Medosome Biotec LLC Pipeline Products & Ongoing Clinical Trials Overview 139

5.75 Micronics Inc Company Overview 140

5.75.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 140

5.76 Minute Molecular Diagnostics Inc Company Overview 142

5.76.1 Minute Molecular Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 142

5.77 MND Diagnostic LTD Company Overview 143

5.77.1 MND Diagnostic LTD Pipeline Products & Ongoing Clinical Trials Overview 143

5.78 Molbio Diagnostics Pvt Ltd Company Overview 144

5.78.1 Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 144

5.79 MyMD Pharmaceuticals Inc Company Overview 145

5.79.1 MyMD Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 145

5.80 Nanobiosym Inc Company Overview 146

5.80.1 Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 146

5.81 NeuMoDx Molecular Inc Company Overview 147

5.81.1 NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 147

5.82 Newmark Diagnostics LLC Company Overview 148

5.82.1 Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 148

5.83 Northwestern University Company Overview 149

5.83.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 149

5.84 Odyssey Thera, inc. (Inactive) Company Overview 150

5.84.1 Odyssey Thera, inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 150

5.85 Oregon Health & Science University Company Overview 151

5.85.1 Oregon Health & Science University Pipeline Products & Ongoing Clinical Trials Overview 151

5.86 Osel Inc Company Overview 152

5.86.1 Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 152

5.87 Paramedical Srl Company Overview 153

5.87.1 Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 153

5.88 Pathogenica Inc Company Overview 154

5.88.1 Pathogenica Inc Pipeline Products & Ongoing Clinical Trials Overview 154

5.89 PATHseq Diagnostics Inc Company Overview 155

5.89.1 PATHseq Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 155

5.90 PixCell Medical Technologies Ltd Company Overview 156

5.90.1 PixCell Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 156

5.91 Prenetics Ltd Company Overview 157

5.91.1 Prenetics Ltd Pipeline Products & Ongoing Clinical Trials Overview 157

5.92 Purdue University Company Overview 158

5.92.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 158

5.93 QuantuMDx Group Ltd Company Overview 159

5.93.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 159

5.94 Quidel Corp Company Overview 160

5.94.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 160

5.95 Radisens Diagnostics Ltd Company Overview 161

5.95.1 Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 161

5.96 Rheonix Inc Company Overview 162

5.96.1 Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 162

5.97 Rice University Company Overview 163

5.97.1 Rice University Pipeline Products & Ongoing Clinical Trials Overview 163

5.98 Roche Diagnostics International Ltd Company Overview 164

5.98.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 164

5.99 Seattle Children’s Hospital Company Overview 167

5.99.1 Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 167

5.100 Sedia Biosciences Corp Company Overview 168

5.100.1 Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 168

5.101 Seegene Inc Company Overview 170

5.101.1 Seegene Inc Pipeline Products & Ongoing Clinical Trials Overview 170

5.102 Senzo Inc Company Overview 171

5.102.1 Senzo Inc Pipeline Products & Ongoing Clinical Trials Overview 171

5.103 Shenzhen New Industries Biomedical Engineering Co Ltd Company Overview 172

5.103.1 Shenzhen New Industries Biomedical Engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

5.104 Siemens Healthineers AG Company Overview 173

5.104.1 Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 173

5.105 Stanford University Company Overview 174

5.105.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 174

5.106 Syamala Srinivasa Life Sciences Pvt. Ltd Company Overview 175

5.106.1 Syamala Srinivasa Life Sciences Pvt. Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

5.107 Taizhou ZECEN Biotech Co Ltd Company Overview 176

5.107.1 Taizhou ZECEN Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 176

5.108 TBG Diagnostics Ltd Company Overview 177

5.108.1 TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 177

5.109 TheoremDx Inc Company Overview 178

5.109.1 TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 178

5.110 TheraDiag SA Company Overview 179

5.110.1 TheraDiag SA Pipeline Products & Ongoing Clinical Trials Overview 179

5.111 Trinity Biotech Plc Company Overview 181

5.111.1 Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 181

5.112 University of California San Diego Company Overview 183

5.112.1 University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 183

5.113 University of Connecticut Company Overview 184

5.113.1 University of Connecticut Pipeline Products & Ongoing Clinical Trials Overview 184

5.114 University of Michigan Company Overview 185

5.114.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 185

5.115 University of Minnesota Company Overview 186

5.115.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 186

5.116 University of the Philippines Manila Company Overview 187

5.116.1 University of the Philippines Manila Pipeline Products & Ongoing Clinical Trials Overview 187

5.117 University of Washington Company Overview 189

5.117.1 University of Washington Pipeline Products & Ongoing Clinical Trials Overview 189

5.118 UrSure Inc Company Overview 191

5.118.1 UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 191

5.119 Ustar Biotechnologies (Hangzhou) Ltd. Company Overview 192

5.119.1 Ustar Biotechnologies (Hangzhou) Ltd. Pipeline Products & Ongoing Clinical Trials Overview 192

5.120 VEGA Ltd Company Overview 193

5.120.1 VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 193

5.121 Wave 80 Biosciences Inc Company Overview 194

5.121.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 194

5.122 Yaathum Biotech Pvt Ltd Company Overview 196

5.122.1 Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 196

6 Human Immunodeficiency Virus (HIV) Tests- Recent Developments 197

6.1 May 01, 2023: Gilead sciences announces launch of Asia pacific rainbow grant 2023 197

6.2 Apr 26, 2023: George Washington University Hosting Webinar on HIV Testing and Screening Guidelines 197

6.3 Mar 02, 2023: UConn Researcher Develops Simple, Affordable HIV Testing Device 198

6.4 Feb 23, 2023: Weill Cornell Medicine awarded NCI grant for EBV-related lymphoma research 198

6.5 Feb 20, 2023: Maternova and MedMira enter distribution agreement to market rapid diagnostics for HIV, syphilis and hepatitis 199

6.6 Feb 15, 2023: Thermo Fisher Scientific launches PCR kits for infectious disease detection in India 200

6.7 Jan 10, 2023: IIT-Goa to research on cost-effective, faster detection of HIV, tuberculosis 200

6.8 Aug 08, 2022: Thermo Fisher Scientific launches enhanced Applied Biosystems HIV-1 genotyping kit 200

7 Appendix 202

7.1 Methodology 202

7.2 About GlobalData 205

7.3 Contact Us 205

7.4 Disclaimer 205

Table

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 19

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Segment 20

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

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Regulatory Path 23

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Estimated Approval Date 24

Human Immunodeficiency Virus (HIV) Tests – Ongoing Clinical Trials 25

Human Immunodeficiency Virus (HIV) Tests Companies – Pipeline Products by Stage of Development 26

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 31

Abbott Rapid Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 35

Urine Tenofovir Rapid Assay – Product Status 35

Urine Tenofovir Rapid Assay – Product Description 35

Abbott Rapid Diagnostics GmbH – Ongoing Clinical Trials Overview 36

Urine Tenofovir Rapid Assay – Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) 37

Accelevir Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 38

Diagnostic Test – Latent HIV-1 Virus – Product Status 38

Diagnostic Test – Latent HIV-1 Virus – Product Description 38

HIV Persistent Proviruses Transcriptional Activity Detection Test – Product Status 39

HIV Persistent Proviruses Transcriptional Activity Detection Test – Product Description 39

HIV Residual Viremia Assay – Product Status 39

HIV Residual Viremia Assay – Product Description 40

HIV-1 EnvLRS Assay – Product Status 40

HIV-1 EnvLRS Assay – Product Description 40

Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Pandaa HIV6 – Product Status 41

Pandaa HIV6 – Product Description 41

PANDAA HIVDR Minor Variants – Product Status 42

PANDAA HIVDR Minor Variants – Product Description 42

PANDAA HIVDR PI+ – Product Status 42

PANDAA HIVDR PI+ – Product Description 43

PANDAA HIVDR RTI – Product Status 43

PANDAA HIVDR RTI – Product Description 43

Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 44

AIMS System – HIV-1 Test – Product Status 44

AIMS System – HIV-1 Test – Product Description 44

AtheNA Multi-Lyte System – HIV-1 Test – Product Status 45

AtheNA Multi-Lyte System – HIV-1 Test – Product Description 45

Allied Innovative Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 46

HIV p24 Antigen ELISA – Product Status 46

HIV p24 Antigen ELISA – Product Description 46

Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

Point-Of-Care Test – HIV Infection – Product Status 47

Point-Of-Care Test – HIV Infection – Product Description 47

Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

Atomo HIV Self Test – Product Status 48

Atomo HIV Self Test – Product Description 48

AtomoRapid HIV – Product Status 49

AtomoRapid HIV – Product Description 49

Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 50

Viral Protein Antibody Test – Non-HIV AIDS – Product Status 50

Viral Protein Antibody Test – Non-HIV AIDS – Product Description 50

Ayanda Biosystems SA (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 51

DETECTHIV – Product Status 51

DETECTHIV – Product Description 51

BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Mobile RDT Reader – HIV1/2 Test – Product Status 52

Mobile RDT Reader – HIV1/2 Test – Product Description 52

Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

Urine Based Rapid HIV Test – Product Status 53

Urine Based Rapid HIV Test – Product Description 53

Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Atlas io System – HIV Assay – Product Status 54

Atlas io System – HIV Assay – Product Description 54

Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Digital Strip Reader – HIV Test – Product Status 55

Digital Strip Reader – HIV Test – Product Description 55

Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 56

Idylla Viral Load Assay – HIV – Product Status 56

Idylla Viral Load Assay – HIV – Product Description 56

BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 57

IsoAmp HIV-1 Quantitative Assay – Product Status 57

IsoAmp HIV-1 Quantitative Assay – Product Description 57

Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 58

BIO-FLASH HIV-1+2 Ag/Ab Assay – Product Status 58

BIO-FLASH HIV-1+2 Ag/Ab Assay – Product Description 58

Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 59

Diagnostic Test – HIV – Product Status 59

Diagnostic Test – HIV – Product Description 59

IOBS – HIV Diagnostic Test – Product Status 60

IOBS – HIV Diagnostic Test – Product Description 60

Blackfly Investments LLC Pipeline Products & Ongoing Clinical Trials Overview 61

Molecular RNA Test – HIV – Product Status 61

Molecular RNA Test – HIV – Product Description 61

Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 62

HIV POC Test – Product Status 62

HIV POC Test – Product Description 62

Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 63

Aware 2 HIV-1/2 – Product Status 63

Aware 2 HIV-1/2 – Product Description 63

Aware HIV-1/2 OMT – Product Status 64

Aware HIV-1/2 OMT – Product Description 64

Second Generation Incidence Test – HIV – Product Status 64

Second Generation Incidence Test – HIV – Product Description 65

Cell Microsystems Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Diagnostic Assay – Latent HIV Reservoir – Product Status 66

Diagnostic Assay – Latent HIV Reservoir – Product Description 66

CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 67

Diagnostic Test – HIV – Product Status 67

Diagnostic Test – HIV – Product Description 67

Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 68

Point-Of-Care Diagnostic Test – HIV-1 – Product Status 68

Point-Of-Care Diagnostic Test – HIV-1 – Product Description 68

Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 69

GeneXpert Omni – HIV-1 Qualitative Test – Product Status 69

GeneXpert Omni – HIV-1 Qualitative Test – Product Description 69

GeneXpert Omni – HIV-1 Viral Load Test – Product Status 70

GeneXpert Omni – HIV-1 Viral Load Test – Product Description 70

Xpert HIV Quant Assay – Product Status 70

Xpert HIV Quant Assay – Product Description 71

Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 72

DPP HIV Ag-Ab Assay – Product Status 72

DPP HIV Ag-Ab Assay – Product Description 72

DPP HIV-Syphilis Assay – Product Status 73

DPP HIV-Syphilis Assay – Product Description 73

Chembio Diagnostic Systems Inc – Ongoing Clinical Trials Overview 74

DPP HIV-Syphilis Assay – Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore 75

CHIP Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 76

ExoTENPO – HIV Assay – Product Status 76

ExoTENPO – HIV Assay – Product Description 76

ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 77

CD4 Assay – HIV – Product Status 77

CD4 Assay – HIV – Product Description 77

Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 78

HIV RNA Real-time PCR Kit – Product Status 78

HIV RNA Real-time PCR Kit – Product Description 78

Conrad Pipeline Products & Ongoing Clinical Trials Overview 79

Biomarker – HIV Acquisition – Product Status 79

Biomarker – HIV Acquisition – Product Description 79

Cornell University Pipeline Products & Ongoing Clinical Trials Overview 80

Diagnostic Test – Acute HIV Infection – Product Status 80

Diagnostic Test – Acute HIV Infection – Product Description 80

CoSara Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 81

Viral Load Test – HIV – Product Status 81

Viral Load Test – HIV – Product Description 82

CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 83

TARApen Test – Product Status 83

TARApen Test – Product Description 83

Cue Inc Pipeline Products & Ongoing Clinical Trials Overview 84

Cue HIV Viral Load Test – Product Status 84

Cue HIV Viral Load Test – Product Description 84

Cupid Ltd Pipeline Products & Ongoing Clinical Trials Overview 85

HIV 1/2 Ab Test – Product Status 85

HIV 1/2 Ab Test – Product Description 85

Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 86

Aspect – HIV Viral Load Test – Product Status 86

Aspect – HIV Viral Load Test – Product Description 86

Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Paper-Based Microfluidic Device – HIV – Product Status 87

Paper-Based Microfluidic Device – HIV – Product Description 87

Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 88

SAMBA – HIV-1 Viral Load Assay – Product Status 88

SAMBA – HIV-1 Viral Load Assay – Product Description 88

SAMBA VL – Product Status 89

SAMBA VL – Product Description 89

SAS – HIV Assay – Product Status 89

SAS – HIV Assay – Product Description 89

Diagnostics for the Real World Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

SAMBA III – Product Status 90

SAMBA III – Product Description 90

Discidium Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 91

Screening Test – HIV Drug Resistance – Product Status 91

Screening Test – HIV Drug Resistance – Product Description 91

DNAE Group Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

USB Stick-Based HIV Test – Product Status 92

USB Stick-Based HIV Test – Product Description 92

Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 93

ADAP HIV Assay – Product Status 93

ADAP HIV Assay – Product Description 93

Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Rapid Immunoassay Test – HIV 1 And 2 – Product Status 94

Rapid Immunoassay Test – HIV 1 And 2 – Product Description 94

Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 95

AmpiProbe HIV Viral Load Assay – Product Status 95

AmpiProbe HIV Viral Load Assay – Product Description 95

Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 96

Epinex G1A – Neo-natal HIV Test – Product Status 96

Epinex G1A – Neo-natal HIV Test – Product Description 96

ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 97

BART – HIV Viral Load Test – Product Status 97

BART – HIV Viral Load Test – Product Description 97

Early Infant Diagnostic Assay – HIV – Product Status 98

Early Infant Diagnostic Assay – HIV – Product Description 98

Next Generation HIV Viral Load Monitoring Test – Product Status 98

Next Generation HIV Viral Load Monitoring Test – Product Description 99

Eurobio Scientific SA Pipeline Products & Ongoing Clinical Trials Overview 100

CO-3S Companion Diagnostic Assay – Product Status 100

CO-3S Companion Diagnostic Assay – Product Description 100

DIAG-3S Diagnostic Assay – Product Status 101

DIAG-3S Diagnostic Assay – Product Description 101

Disease Evolution Predictive Test – AIDS – Product Status 101

Disease Evolution Predictive Test – AIDS – Product Description 101

Fast Track Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

FTD HIV Assay – Product Status 102

FTD HIV Assay – Product Description 102

Fluxergy LLC Pipeline Products & Ongoing Clinical Trials Overview 103

Diagnostic Test – HIV-1 Viral Load – Product Status 103

Diagnostic Test – HIV-1 Viral Load – Product Description 103

Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 104

Lumipulse G – HIV 1/2 Assay Kit – Product Status 104

Lumipulse G – HIV 1/2 Assay Kit – Product Description 104

Lumipulse G – HIV-1p24 Assay Kit – Product Status 105

Lumipulse G – HIV-1p24 Assay Kit – Product Description 105

Lumipulse G – HIVAg/Ab Assay Kit – Product Status 105

Lumipulse G – HIVAg/Ab Assay Kit – Product Description 106

G Medical Health and Wellness Pipeline Products & Ongoing Clinical Trials Overview 107

HIV Test – Product Status 107

HIV Test – Product Description 107

GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 108

Point-Of-Care Diagnostic Test – HIV – Product Status 108

Point-Of-Care Diagnostic Test – HIV – Product Description 108

genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 109

Genedrive – HIV Assay – Product Status 109

Genedrive – HIV Assay – Product Description 109

Genome Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

CD4 Real Time PCR Kit – Product Status 110

CD4 Real Time PCR Kit – Product Description 110

CD8 Real Time PCR Kit – Product Status 111

CD8 Real Time PCR Kit – Product Description 111

HIV-2 Real Time PCR Kit – Product Status 111

HIV-2 Real Time PCR Kit – Product Description 112

Multiplex CD4/CD8 Real Time PCR Kit – HIV – Product Status 112

Multiplex CD4/CD8 Real Time PCR Kit – HIV – Product Description 112

Goodgene Inc Pipeline Products & Ongoing Clinical Trials Overview 113

HIV-1/2 Multiplex RT-PCR Kit – Product Status 113

HIV-1/2 Multiplex RT-PCR Kit – Product Description 113

Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 114

KromaHealth Kit – HIV Ab/Ag – Product Status 114

KromaHealth Kit – HIV Ab/Ag – Product Description 114

Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 115

Accre Diagnostic Assay – HIV Combo – Product Status 115

Accre Diagnostic Assay – HIV Combo – Product Description 116

HA TECH Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

HIV 1&2 Rapid Antibody Test Kit – Product Status 117

HIV 1&2 Rapid Antibody Test Kit – Product Description 117

Human Immunodeficiency Virus Type 1 RT-PCR Detection Kit – Product Status 118

Human Immunodeficiency Virus Type 1 RT-PCR Detection Kit – Product Description 118

HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 119

HF-PCR Point Of Care HIV Viral Load Assay – Product Status 119

HF-PCR Point Of Care HIV Viral Load Assay – Product Description 119

Identifysensors LLC Pipeline Products & Ongoing Clinical Trials Overview 120

Check4-HIV – Product Status 120

Check4-HIV – Product Description 120

Immunetics Inc Pipeline Products & Ongoing Clinical Trials Overview 121

Diagnostic Test – HIV – Product Status 121

Diagnostic Test – HIV – Product Description 121

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 122

Diagnostic Assay – HIV – Product Status 122

Diagnostic Assay – HIV – Product Description 122

Institute for Development Research Pipeline Products & Ongoing Clinical Trials Overview 123

RT-qPCR HIV-1 Viral Load Assay – Product Status 123

RT-qPCR HIV-1 Viral Load Assay – Product Description 123

Integrated Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 124

HIV Diagnostic Test – Product Status 124

HIV Diagnostic Test – Product Description 124

Intelligent Bio Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 125

Diagnostic Test – HIV Infection – Product Status 125

Diagnostic Test – HIV Infection – Product Description 125

Intuitive Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 126

IRIS-HIV Assay – Product Status 126

IRIS-HIV Assay – Product Description 126

Invex Health Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 127

Oral Fluid-Based HIV Self-Test – Product Status 127

Oral Fluid-Based HIV Self-Test – Product Description 127

IRIS International Inc Pipeline Products & Ongoing Clinical Trials Overview 128

NADIA – HIV – Product Status 128

NADIA – HIV – Product Description 128

Jan Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 129

HIV Reservoir RNAamp Assay – Product Status 129

HIV Reservoir RNAamp Assay – Product Description 129

Point-Of-Care Oral Diagnostic Test – HIV – Product Status 130

Point-Of-Care Oral Diagnostic Test – HIV – Product Description 130

Sequence-Based RNA Fluorescence Assay – HIV – Product Status 130

Sequence-Based RNA Fluorescence Assay – HIV – Product Description 131

Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 132

nanoGold Test – Product Status 132

nanoGold Test – Product Description 132

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 133

Magnetic Nanowire – Product Status 133

Magnetic Nanowire – Product Description 133

Point-Of-Care Test – Pediatric HIV – Product Status 134

Point-Of-Care Test – Pediatric HIV – Product Description 134

Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 135

Multiplex Lateral Flow Immunoassay – Product Status 135

Multiplex Lateral Flow Immunoassay – Product Description 135

MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 136

MedDuo Dual HIV Ab/Ag Test – Product Status 136

MedDuo Dual HIV Ab/Ag Test – Product Description 136

Reveal G4 Rapid HIV-1 Antibody Test – Product Status 137

Reveal G4 Rapid HIV-1 Antibody Test – Product Description 137

MedNostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 138

MedNetic HIV Immunoassay – Product Status 138

MedNetic HIV Immunoassay – Product Description 138

Medosome Biotec LLC Pipeline Products & Ongoing Clinical Trials Overview 139

HIV Drug Resistance Assay – Product Status 139

HIV Drug Resistance Assay – Product Description 139

Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 140

MTCT – HIV Assay – Product Status 140

MTCT – HIV Assay – Product Description 140

PanNAT – HIV Assay – Product Status 141

PanNAT – HIV Assay – Product Description 141

Minute Molecular Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 142

DASH HIV Viral Load Test – Product Status 142

DASH HIV Viral Load Test – Product Description 142

MND Diagnostic LTD Pipeline Products & Ongoing Clinical Trials Overview 143

Diagnostic Kit – AIDS – Product Status 143

Diagnostic Kit – AIDS – Product Description 143

Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 144

Truenat HIV-1/2 Assay – Product Status 144

Truenat HIV-1/2 Assay – Product Description 144

MyMD Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 145

PIFA HIV 1+2 Rapid Assay – Product Status 145

PIFA HIV 1+2 Rapid Assay – Product Description 145

Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 146

Gene-Radar – HIV Viral Load Assay – Product Status 146

Gene-Radar – HIV Viral Load Assay – Product Description 146

NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 147

NeuMoDx HIV Assay – Product Status 147

NeuMoDx HIV Assay – Product Description 147

Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 148

Point-Of-Care Diagnostic Test – HIV – Product Status 148

Point-Of-Care Diagnostic Test – HIV – Product Description 148

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 149

Infant HIV Test – Product Status 149

Infant HIV Test – Product Description 149

Odyssey Thera, inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 150

Diagnostic Assay – HIV Infection – Product Status 150

Diagnostic Assay – HIV Infection – Product Description 150

Oregon Health & Science University Pipeline Products & Ongoing Clinical Trials Overview 151

Biomarker Test – HIV – Product Status 151

Biomarker Test – HIV – Product Description 151

Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 152

Point-Of-Care Diagnostic Test – HIV-1 Infection – Product Status 152

Point-Of-Care Diagnostic Test – HIV-1 Infection – Product Description 152

Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 153

PKL PPC 960 – HIV Ag/Ab – Product Status 153

PKL PPC 960 – HIV Ag/Ab – Product Description 153

Pathogenica Inc Pipeline Products & Ongoing Clinical Trials Overview 154

DxSeq – HIV Test – Product Status 154

DxSeq – HIV Test – Product Description 154

PATHseq Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 155

Diagnostic Assay – HIV – Product Status 155

Diagnostic Assay – HIV – Product Description 155

PixCell Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 156

Diagnostic Test – CD4+ Lymphocytes – Product Status 156

Diagnostic Test – CD4+ Lymphocytes – Product Description 156

Prenetics Ltd Pipeline Products & Ongoing Clinical Trials Overview 157

30-Minute Home Test Kit – HIV – Product Status 157

30-Minute Home Test Kit – HIV – Product Description 157

Purdue University Pipeline Products & Ongoing Clinical Trials Overview 158

Diagnostic Test – HIV Infection – Product Status 158

Diagnostic Test – HIV Infection – Product Description 158

QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 159

Q-POC – HIV Assay – Product Status 159

Q-POC – HIV Assay – Product Description 159

Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 160

Savanna – HIV VL Assay – Product Status 160

Savanna – HIV VL Assay – Product Description 160

Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 161

Diagnostic Panel – HIV – Product Status 161

Diagnostic Panel – HIV – Product Description 161

Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 162

Rheonix CARD – HIV Assay – Product Status 162

Rheonix CARD – HIV Assay – Product Description 162

Rice University Pipeline Products & Ongoing Clinical Trials Overview 163

Programmable Bio-Nano-Chip – HIV/AIDS – Product Status 163

Programmable Bio-Nano-Chip – HIV/AIDS – Product Description 163

Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 164

Cobas 4000 Analyzer Series With c 311 Module – HIV Combi PT Assay – Product Status 164

Cobas 4000 Analyzer Series With c 311 Module – HIV Combi PT Assay – Product Description 164

Cobas 5800 – HIV-1/HIV-2 Qualitative Test – Product Status 165

Cobas 5800 – HIV-1/HIV-2 Qualitative Test – Product Description 165

Integrated Modular Analytics – HIV Combi Test – Product Status 165

Integrated Modular Analytics – HIV Combi Test – Product Description 166

Liat HIV-1 Viral Load Assay – Product Status 166

Liat HIV-1 Viral Load Assay – Product Description 166

Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 167

Diagnostic Test – HIV – Product Status 167

Diagnostic Test – HIV – Product Description 167

Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 168

Asanté HIV-1/2 Oral Self-Test – Product Status 168

Asanté HIV-1/2 Oral Self-Test – Product Description 168

Asanté Rapid HIV-1 Recency (or Incidence) Assay – Product Status 169

Asanté Rapid HIV-1 Recency (or Incidence) Assay – Product Description 169

Seegene Inc Pipeline Products & Ongoing Clinical Trials Overview 170

Allplex – HIV Q Assay – Product Status 170

Allplex – HIV Q Assay – Product Description 170

Senzo Inc Pipeline Products & Ongoing Clinical Trials Overview 171

Amplified Lateral Flow Test – HIV – Product Status 171

Amplified Lateral Flow Test – HIV – Product Description 171

Shenzhen New Industries Biomedical Engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

MAGLUMI 2000 – HIV – Product Status 172

MAGLUMI 2000 – HIV – Product Description 172

Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 173

Selzentry Companion Diagnostic Test – Product Status 173

Selzentry Companion Diagnostic Test – Product Description 173

Stanford University Pipeline Products & Ongoing Clinical Trials Overview 174

Ultra-Sensitive Test – HIV – Product Status 174

Ultra-Sensitive Test – HIV – Product Description 174

Syamala Srinivasa Life Sciences Pvt. Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

Human Immunodeficiency Virus Test – Product Status 175

Human Immunodeficiency Virus Test – Product Description 175

Taizhou ZECEN Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 176

HIV Ag/Ab Detection Kit – Product Status 176

HIV Ag/Ab Detection Kit – Product Description 176

TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 177

Diagnostic Assay – HIV – Product Status 177

Diagnostic Assay – HIV – Product Description 177

TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 178

Rapid Diagnostic Test – HIV – Product Status 178

Rapid Diagnostic Test – HIV – Product Description 178

TheraDiag SA Pipeline Products & Ongoing Clinical Trials Overview 179

Companion Diagnostic Assay – HIV/AIDS – Product Status 179

Companion Diagnostic Assay – HIV/AIDS – Product Description 179

HIV Tropism Kit – Product Status 180

HIV Tropism Kit – Product Description 180

Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 181

HIV Self-Test Kit – Product Status 181

HIV Self-Test Kit – Product Description 181

TrinScreen HIV – Product Status 182

TrinScreen HIV – Product Description 182

University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 183

Diagnostic Test – HIV – Product Status 183

Diagnostic Test – HIV – Product Description 183

University of Connecticut Pipeline Products & Ongoing Clinical Trials Overview 184

AIOD-CRISPR Assay – HIV – Product Status 184

AIOD-CRISPR Assay – HIV – Product Description 184

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 185

Microscale Western Blot Immunoassay – HIV – Product Status 185

Microscale Western Blot Immunoassay – HIV – Product Description 185

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 186

Lateral Flow Assay – HIV-1 – Product Status 186

Lateral Flow Assay – HIV-1 – Product Description 186

University of the Philippines Manila Pipeline Products & Ongoing Clinical Trials Overview 187

Paper-Based Diagnostic Kit – HIV Drug Resistance – Product Status 187

Paper-Based Diagnostic Kit – HIV Drug Resistance – Product Description 187

Rapid Diagnostic Test – Lamivudine Resistance – Product Status 188

Rapid Diagnostic Test – Lamivudine Resistance – Product Description 188

University of Washington Pipeline Products & Ongoing Clinical Trials Overview 189

Diagnostic Test – HIV – Product Status 189

Diagnostic Test – HIV – Product Description 189

Electrokinetic Paper Based-Nucleic Acid Amplification Assay – Product Status 190

Electrokinetic Paper Based-Nucleic Acid Amplification Assay – Product Description 190

UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 191

PrEP Adherence Test – HIV – Product Status 191

PrEP Adherence Test – HIV – Product Description 191

Ustar Biotechnologies (Hangzhou) Ltd. Pipeline Products & Ongoing Clinical Trials Overview 192

RT CPA HIV-1 Viral Load Test – Product Status 192

RT CPA HIV-1 Viral Load Test – Product Description 192

VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 193

Diagnostic Assay – HIV – Product Status 193

Diagnostic Assay – HIV – Product Description 193

Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 194

EOSCAPE HIV-1 RNA Viral Load Test – Product Status 194

EOSCAPE HIV-1 RNA Viral Load Test – Product Description 194

EOSCAPE-HIV RNA PLUS – Product Status 195

EOSCAPE-HIV RNA PLUS – Product Description 195

Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 196

Rapid Diagnostic Test – HIV – Product Status 196

Rapid Diagnostic Test – HIV – Product Description 196

Glossary 204

Figures

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Stage of Development 19

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Segment 20

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

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Regulatory Path 23

Human Immunodeficiency Virus (HIV) Tests – Pipeline Products by Estimated Approval Date 24

Human Immunodeficiency Virus (HIV) Tests – Ongoing Clinical Trials 25

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Head of Consumer Sensory Insights, Givaudan

GlobalData provides a great range of information and reports on various sectors that is highly relevant, timely, easy to access and utilise.  The reports and data dashboards help engagement with clients; they provide valuable industry and market insights that can enrich client conversations and can help in the shaping of value propositions. Moreover, using GlobalData products has helped increase my knowledge of the finance sector, the players within it, and the general threats and opportunities.

I find the consumer surveys that are carried out to be extremely beneficial and not something I have seen anywhere else. They provided an insightful view of why and which consumers take (or don’t) particular financial products. This can help shape conversations with clients to ensure they make the right strategic decisions for their business.

One of the challenges I have found is that data in the payments space is often piecemeal. With GD all of the data I need is in one place, but it also comes with additional market reports that provide useful extra context and information. Having the ability to set-up alerts on relevant movements in the industry, be it competitors or customers, and have them emailed directly to me, ensures I get early sight of industry activity and don’t have to search for news.

Senior Account Manager, TSYS
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