HIV Point of Care (POC) Tests Pipeline by Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies

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HIV Point of Care (POC) Pipeline Market Report Overview

Point of Care Testing (POC) is typically performed by non-laboratory personnel outside the clinical laboratory close to where the patient is receiving care. The results obtained from such tests are used for clinical decision-making. The HIV Point of Care (POC) 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 Territories ·        The US

·        Europe

·        China

·        India

·        Japan

Key Regulatory Paths ·        PMA

·        CE-IVD

·        510(k)

·        NMPA

·        ICAC

Leading Companies ·        Abbott Rapid Diagnostics GmbH

·        Aldatu Biosciences Inc

·        Altratech Ltd

·        Atomo Diagnostics Ltd

·        Baebies Inc

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HIV Point of Care (POC) Pipeline Market Segmentation by Territories

A few of the key territories for HIV Point of Care (POC) pipeline products are the US, Europe, China, India, and Japan. As of December 2023, the US accounted for the highest number of pipeline products.

HIV Point of Care (POC) Pipeline Market Analysis by Territories, 2023 (%)

HIV Point of Care (POC) Pipeline Market Analysis by Territories, 2023 (%)

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HIV Point of Care (POC) Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the HIV Point of Care (POC) pipeline market are PMA, CE-IVD, 510(k), NMPA, and ICAC. As of December 2023, PMA was the most followed pathway for pipeline products in the market.

HIV Point of Care (POC) Pipeline Market Analysis by Regulatory Paths, 2023 (%)

HIV Point of Care (POC) Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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HIV Point of Care (POC) Pipeline Market – Competitive Landscape

A few of the key companies associated with the HIV Point of Care (POC) pipeline market are Abbott Rapid Diagnostics GmbH, Aldatu Biosciences Inc, Altratech Ltd, Atomo Diagnostics Ltd, Baebies Inc, among others.

Atomo Diagnostics Ltd: Atomo is headquartered in Sydney, New South Wales, Australia. The company has operations in South Africa, the UK and Australia. It is a medical device company that designs, develops, manufactures, and commercializes in-vitro diagnostic products. The company’s products are used for self-test consumer applications for detecting infectious diseases, measuring markers and hormone levels, and screening for chronic conditions.

Baebies Inc: The company is involved in developing new technology and new tests for healthcare professionals and parents worldwide. Thus, it helps save lives and make lives better for children. The company offers Seeker, a platform for newborn screening authorized by the FDA, to find lysosomal storage disorders.

HIV Point of Care (POC) Pipeline Market Analysis by Companies, 2023

HIV Point of Care (POC) Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

HIV Point of Care (POC) Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • India
  • Japan

HIV Point of Care (POC) Pipeline Market Regulatory Paths Outlook

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

Scope

This report provides:

  • Extensive coverage of the HIV Point of Care (POC) 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 Point of Care (POC) 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

The report will enable you to:

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

Abbott Rapid Diagnostics GmbH
Aldatu Biosciences Inc
Altratech Ltd
Atomo Diagnostics Ltd
Baebies Inc
BBB Technologies Inc
Beijing Wantai Biological Pharmacy Enterprise Co Ltd
Binx Health Inc
Bio-AMD Inc
Biocartis Group NV
BioHelix Corp
Bluejay Diagnostics Inc
Calypte Biomedical Corporation
Centre International de Reference Chantal Biya
Cepheid Inc
ChipCare Corp
CrossLife Technologies Inc
Cue Inc
Daktari Diagnostics, Inc.
Diagnostics For All Inc
Diagnostics for the Real World (Europe) Ltd
Endeavor Sciences Inc
Epinex Diagnostics Inc
ERBA Molecular Ltd
Fluxergy LLC
GAIA Medical Institute LLC
genedrive plc
Group K Diagnostics
Guangzhou Wondfo Biotech Co Ltd
HA TECH Pty Ltd
HeatFlow Technologies Inc
Identifysensors LLC
Imperial College London
Integrated Diagnostics Inc (Inactive)
Intuitive Biosciences Inc
Jan Biotech Inc
Jinvator Bio Med GmbH
Johns Hopkins University
Lynntech Inc
Maxim Biomedical Inc
MedMira Inc
Micronics Inc
Molbio Diagnostics Pvt Ltd
MyMD Pharmaceuticals Inc
Nanobiosym Inc
Newmark Diagnostics LLC
Northwestern University
Osel Inc
Philmedi Co Ltd
Prenetics Ltd
QuantuMDx Group Ltd
Quidel Corp
Radisens Diagnostics Ltd
Rheonix Inc
Roche Diagnostics International Ltd
Sedia Biosciences Corp
Sensible Diagnostics Inc
Senzo Inc
TheoremDx Inc
Trinity Biotech Plc
University of Connecticut
University of Minnesota
UrSure Inc
Ustar Biotechnologies (Hangzhou) Ltd.
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 6

1.2 List of Figures 11

2 Introduction 12

2.1 HIV Point of care (POC) Tests Overview 12

3 Products under Development 13

3.1 HIV Point of care (POC) Tests – Pipeline Products by Stage of Development 13

3.2 HIV Point of care (POC) Tests – Pipeline Products by Territory 14

3.3 HIV Point of care (POC) Tests – Pipeline Products by Regulatory Path 15

3.4 HIV Point of care (POC) Tests – Pipeline Products by Estimated Approval Date 16

3.5 HIV Point of care (POC) Tests – Ongoing Clinical Trials 17

4 HIV Point of care (POC) Tests – Pipeline Products under Development by Companies 18

4.1 HIV Point of care (POC) Tests Companies – Pipeline Products by Stage of Development 18

4.2 HIV Point of care (POC) Tests – Pipeline Products by Stage of Development 21

5 HIV Point of care (POC) Tests Companies and Product Overview 23

5.1 Abbott Rapid Diagnostics GmbH Company Overview 23

5.1.1 Abbott Rapid Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 23

5.2 Aldatu Biosciences Inc Company Overview 26

5.2.1 Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.3 Altratech Ltd Company Overview 27

5.3.1 Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 Atomo Diagnostics Ltd Company Overview 28

5.4.1 Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

5.5 Baebies Inc Company Overview 30

5.5.1 Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.6 BBB Technologies Inc Company Overview 31

5.6.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Company Overview 32

5.7.1 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.8 Binx Health Inc Company Overview 33

5.8.1 Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Bio-AMD Inc Company Overview 34

5.9.1 Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.10 Biocartis Group NV Company Overview 35

5.10.1 Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 35

5.11 BioHelix Corp Company Overview 36

5.11.1 BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 36

5.12 Bluejay Diagnostics Inc Company Overview 37

5.12.1 Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 37

5.13 Calypte Biomedical Corporation Company Overview 38

5.13.1 Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 38

5.14 Centre International de Reference Chantal Biya Company Overview 39

5.14.1 Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 39

5.15 Cepheid Inc Company Overview 40

5.15.1 Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 40

5.16 ChipCare Corp Company Overview 42

5.16.1 ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 42

5.17 CrossLife Technologies Inc Company Overview 43

5.17.1 CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.18 Cue Inc Company Overview 44

5.18.1 Cue Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.19 Daktari Diagnostics, Inc. Company Overview 45

5.19.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 45

5.20 Diagnostics For All Inc Company Overview 46

5.20.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.21 Diagnostics for the Real World (Europe) Ltd Company Overview 47

5.21.1 Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

5.22 Endeavor Sciences Inc Company Overview 49

5.22.1 Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.23 Epinex Diagnostics Inc Company Overview 50

5.23.1 Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.24 ERBA Molecular Ltd Company Overview 51

5.24.1 ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

5.25 Fluxergy LLC Company Overview 52

5.25.1 Fluxergy LLC Pipeline Products & Ongoing Clinical Trials Overview 52

5.26 GAIA Medical Institute LLC Company Overview 53

5.26.1 GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 53

5.27 genedrive plc Company Overview 54

5.27.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 54

5.28 Group K Diagnostics Company Overview 55

5.28.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 55

5.29 Guangzhou Wondfo Biotech Co Ltd Company Overview 56

5.29.1 Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

5.30 HA TECH Pty Ltd Company Overview 58

5.30.1 HA TECH Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

5.31 HeatFlow Technologies Inc Company Overview 60

5.31.1 HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 60

5.32 Identifysensors LLC Company Overview 61

5.32.1 Identifysensors LLC Pipeline Products & Ongoing Clinical Trials Overview 61

5.33 Imperial College London Company Overview 62

5.33.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 62

5.34 Integrated Diagnostics Inc (Inactive) Company Overview 63

5.34.1 Integrated Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 63

5.35 Intuitive Biosciences Inc Company Overview 64

5.35.1 Intuitive Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.36 Jan Biotech Inc Company Overview 66

5.36.1 Jan Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.37 Jinvator Bio Med GmbH Company Overview 67

5.37.1 Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 67

5.38 Johns Hopkins University Company Overview 68

5.38.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 68

5.39 Lynntech Inc Company Overview 69

5.39.1 Lynntech Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.40 Maxim Biomedical Inc Company Overview 70

5.40.1 Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 70

5.41 MedMira Inc Company Overview 71

5.41.1 MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.42 Micronics Inc Company Overview 72

5.42.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.43 Molbio Diagnostics Pvt Ltd Company Overview 74

5.43.1 Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

5.44 MyMD Pharmaceuticals Inc Company Overview 75

5.44.1 MyMD Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.45 Nanobiosym Inc Company Overview 76

5.45.1 Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 76

5.46 Newmark Diagnostics LLC Company Overview 77

5.46.1 Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 77

5.47 Northwestern University Company Overview 78

5.47.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 78

5.48 Osel Inc Company Overview 79

5.48.1 Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.49 Philmedi Co Ltd Company Overview 80

5.49.1 Philmedi Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 80

5.50 Prenetics Ltd Company Overview 81

5.50.1 Prenetics Ltd Pipeline Products & Ongoing Clinical Trials Overview 81

5.51 QuantuMDx Group Ltd Company Overview 82

5.51.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

5.52 Quidel Corp Company Overview 83

5.52.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 83

5.53 Radisens Diagnostics Ltd Company Overview 84

5.53.1 Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

5.54 Rheonix Inc Company Overview 85

5.54.1 Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 85

5.55 Roche Diagnostics International Ltd Company Overview 86

5.55.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

5.56 Sedia Biosciences Corp Company Overview 87

5.56.1 Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 87

5.57 Sensible Diagnostics Inc Company Overview 89

5.57.1 Sensible Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.58 Senzo Inc Company Overview 90

5.58.1 Senzo Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.59 TheoremDx Inc Company Overview 91

5.59.1 TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 91

5.60 Trinity Biotech Plc Company Overview 92

5.60.1 Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 92

5.61 University of Connecticut Company Overview 94

5.61.1 University of Connecticut Pipeline Products & Ongoing Clinical Trials Overview 94

5.62 University of Minnesota Company Overview 95

5.62.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 95

5.63 UrSure Inc Company Overview 96

5.63.1 UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.64 Ustar Biotechnologies (Hangzhou) Ltd. Company Overview 97

5.64.1 Ustar Biotechnologies (Hangzhou) Ltd. Pipeline Products & Ongoing Clinical Trials Overview 97

5.65 Virax Biolabs Group Ltd Company Overview 98

5.65.1 Virax Biolabs Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 98

5.66 Wave 80 Biosciences Inc Company Overview 99

5.66.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 99

5.67 Yaathum Biotech Pvt Ltd Company Overview 101

5.67.1 Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

6 HIV Point of care (POC) Tests- Recent Developments 102

6.1 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 102

6.2 Sep 27, 2023: Update on MedMira’s Regulatory Path in Canada and the USA 102

6.3 Jun 14, 2023: Atomo and Newfoundland Sign Agreement for HIV Testing in Europe 103

6.4 Mar 22, 2023: Trinity Biotech welcomes TrinScreen HIV’s inclusion in the New Kenyan HIV Testing Algorithm 103

6.5 Feb 28, 2023: Significant purchase order for HIV self-tests for Europe 104

7 Appendix 106

7.1 Methodology 106

7.2 About GlobalData 109

7.3 Contact Us 109

7.4 Disclaimer 109

Table

HIV Point of care (POC) Tests – Pipeline Products by Stage of Development 13

HIV Point of care (POC) Tests – Pipeline Products by Territory 14

HIV Point of care (POC) Tests – Pipeline Products by Regulatory Path 15

HIV Point of care (POC) Tests – Pipeline Products by Estimated Approval Date 16

HIV Point of care (POC) Tests – Ongoing Clinical Trials 17

HIV Point of care (POC) Tests Companies – Pipeline Products by Stage of Development 18

HIV Point of care (POC) Tests – Pipeline Products by Stage of Development 21

Abbott Rapid Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 23

Urine Tenofovir Rapid Assay – Product Status 23

Urine Tenofovir Rapid Assay – Product Description 23

Abbott Rapid Diagnostics GmbH – Ongoing Clinical Trials Overview 24

Urine Tenofovir Rapid Assay – Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) 25

Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Pandaa HIV6 – Product Status 26

Pandaa HIV6 – Product Description 26

Altratech Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

Point-Of-Care Test – HIV Infection – Product Status 27

Point-Of-Care Test – HIV Infection – Product Description 27

Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

Atomo HIV Self Test – Product Status 28

Atomo HIV Self Test – Product Description 29

AtomoRapid HIV – Product Status 29

AtomoRapid HIV – Product Description 29

Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Point-of-Care Diagnostic Test – HIV – Product Status 30

Point-of-Care Diagnostic Test – HIV – Product Description 30

BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Mobile RDT Reader – HIV1/2 Test – Product Status 31

Mobile RDT Reader – HIV1/2 Test – Product Description 31

Beijing Wantai Biological Pharmacy Enterprise Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Urine Based Rapid HIV Test – Product Status 32

Urine Based Rapid HIV Test – Product Description 32

Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Atlas io System – HIV Assay – Product Status 33

Atlas io System – HIV Assay – Product Description 33

Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Digital Strip Reader – HIV Test – Product Status 34

Digital Strip Reader – HIV Test – Product Description 34

Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 35

Idylla Viral Load Assay – HIV – Product Status 35

Idylla Viral Load Assay – HIV – Product Description 35

BioHelix Corp Pipeline Products & Ongoing Clinical Trials Overview 36

IsoAmp HIV-1 Quantitative Assay – Product Status 36

IsoAmp HIV-1 Quantitative Assay – Product Description 36

Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 37

HIV POC Test – Product Status 37

HIV POC Test – Product Description 37

Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 38

Aware 2 HIV-1/2 – Product Status 38

Aware 2 HIV-1/2 – Product Description 38

Centre International de Reference Chantal Biya Pipeline Products & Ongoing Clinical Trials Overview 39

Point-Of-Care Diagnostic Test – HIV-1 – Product Status 39

Point-Of-Care Diagnostic Test – HIV-1 – Product Description 39

Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 40

GeneXpert Omni – HIV-1 Qualitative Test – Product Status 40

GeneXpert Omni – HIV-1 Qualitative Test – Product Description 40

GeneXpert Omni – HIV-1 Viral Load Test – Product Status 41

GeneXpert Omni – HIV-1 Viral Load Test – Product Description 41

ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 42

CD4 Assay – HIV – Product Status 42

CD4 Assay – HIV – Product Description 42

CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 43

TARApen Test – Product Status 43

TARApen Test – Product Description 43

Cue Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Cue HIV Viral Load Test – Product Status 44

Cue HIV Viral Load Test – Product Description 44

Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 45

Aspect – HIV Viral Load Test – Product Status 45

Aspect – HIV Viral Load Test – Product Description 45

Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Paper-Based Microfluidic Device – HIV – Product Status 46

Paper-Based Microfluidic Device – HIV – Product Description 46

Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

SAMBA – HIV-1 Viral Load Assay – Product Status 47

SAMBA – HIV-1 Viral Load Assay – Product Description 47

SAMBA VL – Product Status 48

SAMBA VL – Product Description 48

Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 49

Rapid Immunoassay Test – HIV 1 And 2 – Product Status 49

Rapid Immunoassay Test – HIV 1 And 2 – Product Description 49

Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 50

Epinex G1A – Neo-natal HIV Test – Product Status 50

Epinex G1A – Neo-natal HIV Test – Product Description 50

ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

Next Generation HIV Viral Load Monitoring Test – Product Status 51

Next Generation HIV Viral Load Monitoring Test – Product Description 51

Fluxergy LLC Pipeline Products & Ongoing Clinical Trials Overview 52

Diagnostic Test – HIV-1 Viral Load – Product Status 52

Diagnostic Test – HIV-1 Viral Load – Product Description 52

GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 53

Point-Of-Care Diagnostic Test – HIV – Product Status 53

Point-Of-Care Diagnostic Test – HIV – Product Description 53

genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 54

Genedrive – HIV Assay – Product Status 54

Genedrive – HIV Assay – Product Description 54

Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 55

KromaHealth Kit – HIV Ab/Ag – Product Status 55

KromaHealth Kit – HIV Ab/Ag – Product Description 55

Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

Accre Diagnostic Assay – HIV Combo – Product Status 56

Accre Diagnostic Assay – HIV Combo – Product Description 57

HA TECH Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

HIV 1&2 Rapid Antibody Test Kit – Product Status 58

HIV 1&2 Rapid Antibody Test Kit – Product Description 58

Human Immunodeficiency Virus Type 1 RT-PCR Detection Kit – Product Status 59

Human Immunodeficiency Virus Type 1 RT-PCR Detection Kit – Product Description 59

HeatFlow Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 60

HF-PCR Point Of Care HIV Viral Load Assay – Product Status 60

HF-PCR Point Of Care HIV Viral Load Assay – Product Description 60

Identifysensors LLC Pipeline Products & Ongoing Clinical Trials Overview 61

Check4-HIV – Product Status 61

Check4-HIV – Product Description 61

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 62

Diagnostic Assay – HIV – Product Status 62

Diagnostic Assay – HIV – Product Description 62

Integrated Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 63

HIV Diagnostic Test – Product Status 63

HIV Diagnostic Test – Product Description 63

Intuitive Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 64

EV-HIV Assay – Product Status 64

EV-HIV Assay – Product Description 64

IRIS-HIV Assay – Product Status 65

IRIS-HIV Assay – Product Description 65

Jan Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Point-Of-Care Oral Diagnostic Test – HIV – Product Status 66

Point-Of-Care Oral Diagnostic Test – HIV – Product Description 66

Jinvator Bio Med GmbH Pipeline Products & Ongoing Clinical Trials Overview 67

nanoGold Test – Product Status 67

nanoGold Test – Product Description 67

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 68

Point-Of-Care Test – Pediatric HIV – Product Status 68

Point-Of-Care Test – Pediatric HIV – Product Description 68

Lynntech Inc Pipeline Products & Ongoing Clinical Trials Overview 69

Rapid Point-of-Care HIV Viral Load Test – Product Status 69

Rapid Point-of-Care HIV Viral Load Test – Product Description 69

Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 70

Multiplex Lateral Flow Immunoassay – Product Status 70

Multiplex Lateral Flow Immunoassay – Product Description 70

MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 71

Reveal G4 Rapid HIV-1 Antibody Test – Product Status 71

Reveal G4 Rapid HIV-1 Antibody Test – Product Description 71

Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 72

MTCT – HIV Assay – Product Status 72

MTCT – HIV Assay – Product Description 72

PanNAT – HIV Assay – Product Status 73

PanNAT – HIV Assay – Product Description 73

Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

Truenat HIV-1/2 Assay – Product Status 74

Truenat HIV-1/2 Assay – Product Description 74

MyMD Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 75

PIFA HIV 1+2 Rapid Assay – Product Status 75

PIFA HIV 1+2 Rapid Assay – Product Description 75

Nanobiosym Inc Pipeline Products & Ongoing Clinical Trials Overview 76

Gene-Radar – HIV Viral Load Assay – Product Status 76

Gene-Radar – HIV Viral Load Assay – Product Description 76

Newmark Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 77

Point-Of-Care Diagnostic Test – HIV – Product Status 77

Point-Of-Care Diagnostic Test – HIV – Product Description 77

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 78

Infant HIV Test – Product Status 78

Infant HIV Test – Product Description 78

Osel Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Point-Of-Care Diagnostic Test – HIV-1 Infection – Product Status 79

Point-Of-Care Diagnostic Test – HIV-1 Infection – Product Description 79

Philmedi Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 80

HIV POC Molecular Diagnostic Test – Product Status 80

HIV POC Molecular Diagnostic Test – Product Description 80

Prenetics Ltd Pipeline Products & Ongoing Clinical Trials Overview 81

30-Minute Home Test Kit – HIV – Product Status 81

30-Minute Home Test Kit – HIV – Product Description 81

QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

Q-POC – HIV Assay – Product Status 82

Q-POC – HIV Assay – Product Description 82

Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 83

Savanna – HIV VL Assay – Product Status 83

Savanna – HIV VL Assay – Product Description 83

Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

Diagnostic Panel – HIV – Product Status 84

Diagnostic Panel – HIV – Product Description 84

Rheonix Inc Pipeline Products & Ongoing Clinical Trials Overview 85

Rheonix CARD – HIV Assay – Product Status 85

Rheonix CARD – HIV Assay – Product Description 85

Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

Liat HIV-1 Viral Load Assay – Product Status 86

Liat HIV-1 Viral Load Assay – Product Description 86

Sedia Biosciences Corp Pipeline Products & Ongoing Clinical Trials Overview 87

Asanté HIV-1/2 Oral Self-Test – Product Status 87

Asanté HIV-1/2 Oral Self-Test – Product Description 87

Asanté Rapid HIV-1 Recency (or Incidence) Assay – Product Status 88

Asanté Rapid HIV-1 Recency (or Incidence) Assay – Product Description 88

Sensible Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 89

Point-Of-Care Test – HIV – Product Status 89

Point-Of-Care Test – HIV – Product Description 89

Senzo Inc Pipeline Products & Ongoing Clinical Trials Overview 90

Amplified Lateral Flow Test – HIV – Product Status 90

Amplified Lateral Flow Test – HIV – Product Description 90

TheoremDx Inc Pipeline Products & Ongoing Clinical Trials Overview 91

Rapid Diagnostic Test – HIV – Product Status 91

Rapid Diagnostic Test – HIV – Product Description 91

Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 92

HIV Self-Test Kit – Product Status 92

HIV Self-Test Kit – Product Description 92

TrinScreen HIV – Product Status 93

TrinScreen HIV – Product Description 93

University of Connecticut Pipeline Products & Ongoing Clinical Trials Overview 94

AIOD-CRISPR Assay – HIV – Product Status 94

AIOD-CRISPR Assay – HIV – Product Description 94

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 95

Lateral Flow Assay – HIV-1 – Product Status 95

Lateral Flow Assay – HIV-1 – Product Description 95

UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 96

PrEP Adherence Test – HIV – Product Status 96

PrEP Adherence Test – HIV – Product Description 96

Ustar Biotechnologies (Hangzhou) Ltd. Pipeline Products & Ongoing Clinical Trials Overview 97

RT CPA HIV-1 Viral Load Test – Product Status 97

RT CPA HIV-1 Viral Load Test – Product Description 97

Virax Biolabs Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 98

Virax Immune T-Cell Test – HIV – Product Status 98

Virax Immune T-Cell Test – HIV – Product Description 98

Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 99

EOSCAPE HIV-1 RNA Viral Load Test – Product Status 99

EOSCAPE HIV-1 RNA Viral Load Test – Product Description 99

EOSCAPE-HIV RNA PLUS – Product Status 100

EOSCAPE-HIV RNA PLUS – Product Description 100

Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

Rapid Diagnostic Test – HIV – Product Status 101

Rapid Diagnostic Test – HIV – Product Description 101

Glossary 108

Figures

HIV Point of care (POC) Tests – Pipeline Products by Stage of Development 13_x000D_

HIV Point of care (POC) Tests – Pipeline Products by Territory 14_x000D_

HIV Point of care (POC) Tests – Pipeline Products by Regulatory Path 15_x000D_

HIV Point of care (POC) Tests – Pipeline Products by Estimated Approval Date 16_x000D_

HIV Point of care (POC) Tests – Ongoing Clinical Trials 17_x000D_

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HIV Point of Care (POC) Tests Pipeline by Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies thematic reports
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