Diabetes Assays Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Diabetes Assays Pipeline Market Report Overview

Diabetes Assays are tests to first diagnose diabetes and assess the risk of diabetes, such as pre-diabetes, through analysis of blood. The diabetes assays 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

·       India

·       China

·       South Korea

Key Segments ·       Glycated Hemoglobin (HbA1c) Lab Assay

·       Glycated Hemoglobin (HbA1c) Point of care (POC) Assay

·       Insulin Assay

·       Glycated Hemoglobin (HbA1c) Assays

·       C-Peptide Assay

Key Regulatory Paths ·       510(k)

·       CE-IVD

·       NMPA

·       MDITAC

·       MDA

Leading Companies ·       1Drop Diagnostics

·       Abcodia Ltd

·       Abionic SA

·       Adaptive Biotechnologies Corp

·       Adipomics Inc

·       Aditxt Inc

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Diabetes Assays Pipeline Market Segments

A few of the key segments in the diabetes assays pipeline market are Glycated Hemoglobin (HbA1c) Lab Assay, Glycated Hemoglobin (HbA1c) Point of care (POC) Assay, Insulin Assay, Glycated Hemoglobin (HbA1c) Assays, and C-Peptide Assay. As of June 2024, Glycated Hemoglobin (HbA1c) Lab Assay accounts for the highest market share.

Diabetes Assays Pipeline Market Analysis by Segments, 2024 (%)

Diabetes Assays Pipeline Market Analysis by Segments, 2024 (%)

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Diabetes Assays Pipeline Market Segmentation by Territories

A few of the key territories with the diabetes assays pipeline market are the US, Europe, India, China, and South Korea among others. As of June 2024, the US accounts for the highest number of pipeline products.

Diabetes Assays Pipeline Market Analysis by Territories, 2024 (%)

Diabetes Assays Pipeline Market Analysis by Territories, 2024 (%)

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Diabetes Assays Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the diabetes assays pipeline products market are 510(k), CE-IVD, NMPA, MDA, and MDITAC. As of June 2024, 510(k) is the most followed pathway for pipeline products in the diabetes assays market.

Diabetes Assays Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Diabetes Assays Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Diabetes Assays Pipeline Market – Competitive Landscape

A few of the key companies associated with the diabetes assays pipeline market are 1Drop Diagnostics, Abcodia Ltd, Abionic SA, Adaptive Biotechnologies Corp, Adipomics Inc., and Aditxt Inc., among others.

Abcodia Ltd: Abcodia Ltd (Abcodia) is a clinical-stage company that offers commercial development of novel, scientifically validated tests for the early detection of cancer. The company offers Roca Test, a blood test for early ovarian cancer detection. It validates and discovers biomarkers for early diagnosis and screening of cancer. Abcodia develops products for the detection of colorectal cancer, pancreatic cancer, and lung cancer.

Abionic SA: Abionic SA (Abionic) is a medical device company that develops, produces, and markets in vitro diagnostic devices. The company provides products such as abioSCOPE, IVD capsule, abioGUIDE, abioGUIDE application for Android, iPhone, and iPad, and accessories, among others. Its abioSCOPE in vitro tests are designed to deliver specific, semi-quantitative, and personalized information about patients’ allergen sensitization at the point of care.

Diabetes Assays Pipeline Market Analysis by Companies, 2024

Diabetes Assays Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Diabetes Assays Pipeline Market Segments Outlook (2024)

  • Glycated Hemoglobin (HbA1c) Lab Assay
  • Glycated Hemoglobin (HbA1c) Point of care (POC) Assay
  • Insulin Assay
  • Glycated Hemoglobin (HbA1c) Assays
  • C-Peptide Assay

Diabetes Assays Pipeline Market Territories Outlook (2024)

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

Diabetes Assays Pipeline Market Regulatory Paths Outlook (2024)

  • 510(k)
  • CE-IVD
  • NMPA
  • MDA
  • MDITAC

Scope

This report provides:

  • Extensive coverage of the diabetes assays 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 diabetes assays 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 diabetes assays 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 an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

1Drop Diagnostics
Abcodia Ltd
Abionic SA
Adaptive Biotechnologies Corp
Adipomics Inc
Aditxt Inc
Advanced Genetic Diagnostics Pty Ltd
Alfa Wassermann Inc
AmideBio, LLC
Aura Biotechnologies Pvt Ltd
Beckman Coulter Inc
Biocrates Life Sciences AG
BioDesign Institute at Arizona State University
Biogenes Technologies Sdn Bhd
Biomorph Technologies LLC
CellCarta Precision Medicine Inc
Confer Health Inc
Drexel University
Dx&Vx
Electronic BioSciences Inc.
Enable Biosciences Inc
FibroStatin SL
G Medical Innovations Holdings Ltd
GATC DB Care Corp
Gelteq Ltd
Genesis Detection Systems, Inc.
Guangzhou Wondfo Biotech Co Ltd
Helmholtz Centre for Infection Research
Hemex Health Inc
Human Cell Design SAS
Interpace Biosciences Inc
IntraMed Diagnostics, LLC
Janssen Diagnostics LLC
Johns Hopkins University
L2 Diagnostics LLC
Matter Diagnostics
MediSure Canada Inc
Mellitus LLC
MultiOmic Health Ltd
Numares AG
Peri Rx Inc
Phaim Pharma Ltd
Phase Scientific International Ltd
PortaScience Inc
Precision Diabetes LLC
Protagen AG
QSTAG Co Ltd
Queen Mary University of London
QuickCheck Health Inc
Sebia
Sera Prognostics Inc
Singulex Inc
SomaLogic Inc
SpinChip Diagnostics AS
Stanford University
Sugentech Inc
Tetz Laboratories
The Forsyth Institute
University of Canterbury
University of Colorado
University of Florida
University of Newcastle
University of Oxford
University of South Florida
University of Strathclyde
Vactech Oy
Vital Diagnostics, Inc. (Inactive)
Wave 80 Biosciences Inc
Xhale Inc
Yaathum Biotech Pvt Ltd
Yale University

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 7

|1.2 List of Figures 12

2 Introduction 13

2.1 Diabetes Assays Overview 13

3 Products under Development 14

3.1 Diabetes Assays – Pipeline Products by Stage of Development 14

3.2 Diabetes Assays – Pipeline Products by Segment 15

3.3 Diabetes Assays – Pipeline Products by Territory 16

3.4 Diabetes Assays – Pipeline Products by Regulatory Path 17

3.5 Diabetes Assays – Pipeline Products by Estimated Approval Date 18

4 Diabetes Assays – Pipeline Products under Development by Companies 19

4.1 Diabetes Assays Companies – Pipeline Products by Stage of Development 19

4.2 Diabetes Assays – Pipeline Products by Stage of Development 22

5 Diabetes Assays Companies and Product Overview 25

5.1 1Drop Diagnostics Company Overview 25

5.1.1 1Drop Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 25

5.2 Abcodia Ltd Company Overview 26

5.2.1 Abcodia Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

5.3 Abionic SA Company Overview 27

5.3.1 Abionic SA Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 Adaptive Biotechnologies Corp Company Overview 29

5.4.1 Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 29

5.5 Adipomics Inc Company Overview 30

5.5.1 Adipomics Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.6 Aditxt Inc Company Overview 31

5.6.1 Aditxt Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 Advanced Genetic Diagnostics Pty Ltd Company Overview 32

5.7.1 Advanced Genetic Diagnostics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.8 Alfa Wassermann Inc Company Overview 34

5.8.1 Alfa Wassermann Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.9 AmideBio, LLC Company Overview 35

5.9.1 AmideBio, LLC Pipeline Products & Ongoing Clinical Trials Overview 35

5.10 Aura Biotechnologies Pvt Ltd Company Overview 36

5.10.1 Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

5.11 Beckman Coulter Inc Company Overview 38

5.11.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.12 Biocrates Life Sciences AG Company Overview 42

5.12.1 Biocrates Life Sciences AG Pipeline Products & Ongoing Clinical Trials Overview 42

5.13 BioDesign Institute at Arizona State University Company Overview 43

5.13.1 BioDesign Institute at Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 43

5.14 Biogenes Technologies Sdn Bhd Company Overview 44

5.14.1 Biogenes Technologies Sdn Bhd Pipeline Products & Ongoing Clinical Trials Overview 44

5.15 Biomorph Technologies LLC Company Overview 45

5.15.1 Biomorph Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 45

5.16 CellCarta Precision Medicine Inc Company Overview 46

5.16.1 CellCarta Precision Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 Confer Health Inc Company Overview 48

5.17.1 Confer Health Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.18 Drexel University Company Overview 49

5.18.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 49

5.19 Dx&Vx Company Overview 50

5.19.1 Dx&Vx Pipeline Products & Ongoing Clinical Trials Overview 50

5.20 Electronic BioSciences Inc. Company Overview 51

5.20.1 Electronic BioSciences Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

5.21 Enable Biosciences Inc Company Overview 52

5.21.1 Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 52

5.22 FibroStatin SL Company Overview 54

5.22.1 FibroStatin SL Pipeline Products & Ongoing Clinical Trials Overview 54

5.23 G Medical Innovations Holdings Ltd Company Overview 55

5.23.1 G Medical Innovations Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

5.24 GATC DB Care Corp Company Overview 56

5.24.1 GATC DB Care Corp Pipeline Products & Ongoing Clinical Trials Overview 56

5.25 Gelteq Ltd Company Overview 57

5.25.1 Gelteq Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.26 Genesis Detection Systems, Inc. Company Overview 58

5.26.1 Genesis Detection Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

5.27 Guangzhou Wondfo Biotech Co Ltd Company Overview 59

5.27.1 Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

5.28 Helmholtz Centre for Infection Research Company Overview 62

5.28.1 Helmholtz Centre for Infection Research Pipeline Products & Ongoing Clinical Trials Overview 62

5.29 Hemex Health Inc Company Overview 63

5.29.1 Hemex Health Inc Pipeline Products & Ongoing Clinical Trials Overview 63

5.30 Human Cell Design SAS Company Overview 64

5.30.1 Human Cell Design SAS Pipeline Products & Ongoing Clinical Trials Overview 64

5.31 Interpace Biosciences Inc Company Overview 66

5.31.1 Interpace Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.32 IntraMed Diagnostics, LLC Company Overview 67

5.32.1 IntraMed Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 67

5.33 Janssen Diagnostics LLC Company Overview 68

5.33.1 Janssen Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 68

5.34 Johns Hopkins University Company Overview 69

5.34.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 69

5.35 L2 Diagnostics LLC Company Overview 70

5.35.1 L2 Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 70

5.36 Matter Diagnostics Company Overview 71

5.36.1 Matter Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 71

5.37 MediSure Canada Inc Company Overview 72

5.37.1 MediSure Canada Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.38 Mellitus LLC Company Overview 73

5.38.1 Mellitus LLC Pipeline Products & Ongoing Clinical Trials Overview 73

5.39 MultiOmic Health Ltd Company Overview 74

5.39.1 MultiOmic Health Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

5.40 Numares AG Company Overview 76

5.40.1 Numares AG Pipeline Products & Ongoing Clinical Trials Overview 76

5.41 Peri Rx Inc Company Overview 77

5.41.1 Peri Rx Inc Pipeline Products & Ongoing Clinical Trials Overview 77

5.42 Phaim Pharma Ltd Company Overview 78

5.42.1 Phaim Pharma Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

5.43 Phase Scientific International Ltd Company Overview 79

5.43.1 Phase Scientific International Ltd Pipeline Products & Ongoing Clinical Trials Overview 79

5.44 PortaScience Inc Company Overview 80

5.44.1 PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.45 Precision Diabetes LLC Company Overview 81

5.45.1 Precision Diabetes LLC Pipeline Products & Ongoing Clinical Trials Overview 81

5.46 Protagen AG Company Overview 82

5.46.1 Protagen AG Pipeline Products & Ongoing Clinical Trials Overview 82

5.47 QSTAG Co Ltd Company Overview 83

5.47.1 QSTAG Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

5.48 Queen Mary University of London Company Overview 84

5.48.1 Queen Mary University of London Pipeline Products & Ongoing Clinical Trials Overview 84

5.49 QuickCheck Health Inc Company Overview 85

5.49.1 QuickCheck Health Inc Pipeline Products & Ongoing Clinical Trials Overview 85

5.50 Sebia Company Overview 86

5.50.1 Sebia Pipeline Products & Ongoing Clinical Trials Overview 86

5.51 Sera Prognostics Inc Company Overview 87

5.51.1 Sera Prognostics Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.52 Singulex Inc Company Overview 88

5.52.1 Singulex Inc Pipeline Products & Ongoing Clinical Trials Overview 88

5.53 SomaLogic Inc Company Overview 89

5.53.1 SomaLogic Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.54 SpinChip Diagnostics AS Company Overview 90

5.54.1 SpinChip Diagnostics AS Pipeline Products & Ongoing Clinical Trials Overview 90

5.55 Stanford University Company Overview 91

5.55.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 91

5.56 Sugentech Inc Company Overview 92

5.56.1 Sugentech Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.57 Tetz Laboratories Company Overview 93

5.57.1 Tetz Laboratories Pipeline Products & Ongoing Clinical Trials Overview 93

5.58 The Forsyth Institute Company Overview 94

5.58.1 The Forsyth Institute Pipeline Products & Ongoing Clinical Trials Overview 94

5.59 University of Canterbury Company Overview 95

5.59.1 University of Canterbury Pipeline Products & Ongoing Clinical Trials Overview 95

5.60 University of Colorado Company Overview 96

5.60.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 96

5.61 University of Florida Company Overview 97

5.61.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 97

5.62 University of Newcastle Company Overview 99

5.62.1 University of Newcastle Pipeline Products & Ongoing Clinical Trials Overview 99

5.63 University of Oxford Company Overview 100

5.63.1 University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 100

5.64 University of South Florida Company Overview 101

5.64.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 101

5.65 University of Strathclyde Company Overview 102

5.65.1 University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 102

5.66 Vactech Oy Company Overview 103

5.66.1 Vactech Oy Pipeline Products & Ongoing Clinical Trials Overview 103

5.67 Vital Diagnostics, Inc. (Inactive) Company Overview 104

5.67.1 Vital Diagnostics, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 104

5.68 Wave 80 Biosciences Inc Company Overview 105

5.68.1 Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.69 Xhale Inc Company Overview 106

5.69.1 Xhale Inc Pipeline Products & Ongoing Clinical Trials Overview 106

5.70 Yaathum Biotech Pvt Ltd Company Overview 107

5.70.1 Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

5.71 Yale University Company Overview 108

5.71.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview 108

6 Diabetes Assays- Recent Developments 109

6.1 May 15, 2024: Advanced Screening Method for Early Detection of Type 1 Diabetes Exceeds Traditional Standards 109

6.2 Feb 21, 2024: World-First Introduction of Home Oral Glucose Tolerance Testing Service for Gestational Diabetes Sees University Hospital Southampton Improve Test Accessibility and Yield Maximum User Preference Scores 109

6.3 Feb 06, 2024: Beckman Coulter Diagnostics Appoints Kevin O’Reilly as New President 111

6.4 Jan 23, 2024: Enable Biosciences Enhances ‘Kit to Clinics’ With Rigorously Vetted Adap Technology for Diabetes Care 111

6.5 Jan 10, 2024: A New Study Shows Glycomark is a Novel Biomarker of SGLT-2I Adherence 112

6.6 Dec 19, 2023: Enable Biosciences Receives $3M Phase IIB SBIR Award From NIDDK for Advanced T1D Testing Technology 112

6.7 Nov 30, 2023: Switch Health develops Canada’s first at-home diagnostic Diabetes test 113

6.8 Nov 17, 2023: New Research Center for Artificial Intelligence and Causal Methods in Medicine 114

6.9 Oct 30, 2023: New Clinical Data Point To Use of Glycomark as Biomarker of Sglt-2 Diabetes Drug Effectiveness and Compliance 115

6.10 Oct 19, 2023: Abbott Diagnostics Obtains Additional 510(k) Clearance for Afinion HbA1c Test 116

7 Appendix 117

7.1 Methodology 117

7.2 About GlobalData 120

7.3 Contact Us 120

7.4 Disclaimer 120

Table

Diabetes Assays – Pipeline Products by Stage of Development 14

Diabetes Assays – Pipeline Products by Segment 15

Diabetes Assays – Pipeline Products by Territory 16

Diabetes Assays – Pipeline Products by Regulatory Path 17

Diabetes Assays – Pipeline Products by Estimated Approval Date 18

Diabetes Assays Companies – Pipeline Products by Stage of Development 19

Diabetes Assays – Pipeline Products by Stage of Development 22

1Drop Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 25

Hemoglobin A1c (HbA1c) Test – Product Status 25

Hemoglobin A1c (HbA1c) Test – Product Description 25

Abcodia Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

Molecular Biomarker – Diabetes – Product Status 26

Molecular Biomarker – Diabetes – Product Description 26

Abionic SA Pipeline Products & Ongoing Clinical Trials Overview 27

Point of Care Diagnostic Test – Glucose – Product Status 27

Point of Care Diagnostic Test – Glucose – Product Description 27

Point of Care Diagnostic Test – Glycated hemoglobin (HbA1c) – Product Status 28

Point of Care Diagnostic Test – Glycated hemoglobin (HbA1c) – Product Description 28

Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 29

Pre – Symptomatic Biomarker – Type 1 Diabetes – Product Status 29

Pre – Symptomatic Biomarker – Type 1 Diabetes – Product Description 29

Adipomics Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Diagnostic Test – Gestational Pre-Diabetes – Product Status 30

Diagnostic Test – Gestational Pre-Diabetes – Product Description 30

Aditxt Inc Pipeline Products & Ongoing Clinical Trials Overview 31

AditxtScore Assay – Type I Diabetes – Product Status 31

AditxtScore Assay – Type I Diabetes – Product Description 31

Advanced Genetic Diagnostics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Genetic Diagnostic Test – Diabetes – Product Status 32

Genetic Diagnostic Test – Diabetes – Product Description 32

Genetic Diagnostic Test – Diabetic Complications – Product Status 33

Genetic Diagnostic Test – Diabetic Complications – Product Description 33

Alfa Wassermann Inc Pipeline Products & Ongoing Clinical Trials Overview 34

ACE Alera Clinical Chemistry System – Direct A1c Assay – Product Status 34

ACE Alera Clinical Chemistry System – Direct A1c Assay – Product Description 34

AmideBio, LLC Pipeline Products & Ongoing Clinical Trials Overview 35

Diagnostic Test – T1 Diabetes – Product Status 35

Diagnostic Test – T1 Diabetes – Product Description 35

Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

AURA Quant Glargine ELISA Kit – Product Status 36

AURA Quant Glargine ELISA Kit – Product Description 36

AURA Quant Human C-peptide Kit – Product Status 37

AURA Quant Human C-peptide Kit – Product Description 37

AURA Quant Human Insulin ELISA Kit – Product Status 37

AURA Quant Human Insulin ELISA Kit – Product Description 37

Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 38

AU480 Clinical System – Next Generation HbA1c Assay – Product Status 38

AU480 Clinical System – Next Generation HbA1c Assay – Product Description 38

AU5810 Clinical System – Next-generation HbA1c Assay – Product Status 39

AU5810 Clinical System – Next-generation HbA1c Assay – Product Description 39

AU5820 Clinical System – Next-generation HbA1c Assay – Product Status 39

AU5820 Clinical System – Next-generation HbA1c Assay – Product Description 39

AU5830 Clinical System – Next-generation HbA1c Assay – Product Status 40

AU5830 Clinical System – Next-generation HbA1c Assay – Product Description 40

AU5840 Clinical System – Next-generation HbA1c Assay – Product Status 40

AU5840 Clinical System – Next-generation HbA1c Assay – Product Description 40

AU680 Clinical System – Next-generation HbA1c Assay – Product Status 41

AU680 Clinical System – Next-generation HbA1c Assay – Product Description 41

Biocrates Life Sciences AG Pipeline Products & Ongoing Clinical Trials Overview 42

Diagnostic Assay – Type 2 Diabetes – Product Status 42

Diagnostic Assay – Type 2 Diabetes – Product Description 42

BioDesign Institute at Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 43

Biomarker Test – Type 1 Diabetes – Product Status 43

Biomarker Test – Type 1 Diabetes – Product Description 43

Biogenes Technologies Sdn Bhd Pipeline Products & Ongoing Clinical Trials Overview 44

Aptamer-Based Diagnostic Kit – Diabetes – Product Status 44

Aptamer-Based Diagnostic Kit – Diabetes – Product Description 44

Biomorph Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 45

Serologic Test – Type 1 Diabetes Mellitus – Product Status 45

Serologic Test – Type 1 Diabetes Mellitus – Product Description 45

CellCarta Precision Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Diagnostic Assay – Gestational Diabetes Progression – Product Status 46

Diagnostic Assay – Gestational Diabetes Progression – Product Description 46

Diagnostic Assay – Islet Cell Health – Product Status 47

Diagnostic Assay – Islet Cell Health – Product Description 47

Confer Health Inc Pipeline Products & Ongoing Clinical Trials Overview 48

Diagnostic Panel – Diabetes – Product Status 48

Diagnostic Panel – Diabetes – Product Description 48

Drexel University Pipeline Products & Ongoing Clinical Trials Overview 49

Diagnostic Assay – Diabetic Ulcers – Product Status 49

Diagnostic Assay – Diabetic Ulcers – Product Description 49

Dx&Vx Pipeline Products & Ongoing Clinical Trials Overview 50

Gestational Diabetes Test – Product Status 50

Gestational Diabetes Test – Product Description 50

Electronic BioSciences Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

Point-of-Care Test – Type 1 Diabetes – Product Status 51

Point-of-Care Test – Type 1 Diabetes – Product Description 51

Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 52

ADAP Type1 Diabetes Assay – Product Status 52

ADAP Type1 Diabetes Assay – Product Description 52

DBS T1D Autoantibody Assay – Product Status 53

DBS T1D Autoantibody Assay – Product Description 53

FibroStatin SL Pipeline Products & Ongoing Clinical Trials Overview 54

EMTEST – Type 2 Diabetes – Product Status 54

EMTEST – Type 2 Diabetes – Product Description 54

G Medical Innovations Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

HbA1c Test – Product Status 55

HbA1c Test – Product Description 55

GATC DB Care Corp Pipeline Products & Ongoing Clinical Trials Overview 56

Predictive Test – Type 2 Diabetes – Product Status 56

Predictive Test – Type 2 Diabetes – Product Description 56

Gelteq Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Diabetes Screening Kit – Product Status 57

Diabetes Screening Kit – Product Description 57

Genesis Detection Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

Rapid Home Test – Hemoglobin A1c – Product Status 58

Rapid Home Test – Hemoglobin A1c – Product Description 58

Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

Accre Diagnostic Assay – C-peptide – Product Status 59

Accre Diagnostic Assay – C-peptide – Product Description 59

Accre Diagnostic Assay – Copeptin – Product Status 60

Accre Diagnostic Assay – Copeptin – Product Description 60

Accre Diagnostic Assay – Insulin – Product Status 60

Accre Diagnostic Assay – Insulin – Product Description 61

Helmholtz Centre for Infection Research Pipeline Products & Ongoing Clinical Trials Overview 62

Biomarker Test – Type 2 Diabetes – Product Status 62

Biomarker Test – Type 2 Diabetes – Product Description 62

Hemex Health Inc Pipeline Products & Ongoing Clinical Trials Overview 63

HemeChip – Hemoglobin A1C Test – Product Status 63

HemeChip – Hemoglobin A1C Test – Product Description 63

Human Cell Design SAS Pipeline Products & Ongoing Clinical Trials Overview 64

Type I Diabetes Assay – Product Status 64

Type I Diabetes Assay – Product Description 64

Type II Diabetes Assay – Product Status 65

Type II Diabetes Assay – Product Description 65

Interpace Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Point2Glucose – Product Status 66

Point2Glucose – Product Description 66

IntraMed Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 67

Point-Of-Care Diagnostic Assay – HbA1c – Product Status 67

Point-Of-Care Diagnostic Assay – HbA1c – Product Description 67

Janssen Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 68

Diagnostic Biomarker – Beta-cell Function – Product Status 68

Diagnostic Biomarker – Beta-cell Function – Product Description 68

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 69

Screening Test – Gestational Diabetes – Product Status 69

Screening Test – Gestational Diabetes – Product Description 69

L2 Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 70

Droplet Digital PCR Assay – Type I Diabetes Mellitus – Product Status 70

Droplet Digital PCR Assay – Type I Diabetes Mellitus – Product Description 70

Matter Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 71

Type 1 Diabetes Prediction And Screening Test – Product Status 71

Type 1 Diabetes Prediction And Screening Test – Product Description 71

MediSure Canada Inc Pipeline Products & Ongoing Clinical Trials Overview 72

At-Home Diagnostic Test – Diabetes Management – Product Status 72

At-Home Diagnostic Test – Diabetes Management – Product Description 72

Mellitus LLC Pipeline Products & Ongoing Clinical Trials Overview 73

Blood Test – Gestational Diabetes – Product Status 73

Blood Test – Gestational Diabetes – Product Description 73

MultiOmic Health Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

Diagnostic Tool – Diabetic Kidney Disease – Product Status 74

Diagnostic Tool – Diabetic Kidney Disease – Product Description 74

Prognostic Tool – Diabetic Kidney Disease – Product Status 75

Prognostic Tool – Diabetic Kidney Disease – Product Description 75

Numares AG Pipeline Products & Ongoing Clinical Trials Overview 76

Axinon Test – Diabetes – Product Status 76

Axinon Test – Diabetes – Product Description 76

Peri Rx Inc Pipeline Products & Ongoing Clinical Trials Overview 77

SaliMark D2 – Product Status 77

SaliMark D2 – Product Description 77

Phaim Pharma Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

Cellular T1DM Biomarker Kit – Product Status 78

Cellular T1DM Biomarker Kit – Product Description 78

Phase Scientific International Ltd Pipeline Products & Ongoing Clinical Trials Overview 79

INDICAID Diabetes 1 Test – Product Status 79

INDICAID Diabetes 1 Test – Product Description 79

PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 80

HbA1c Blood Test – Product Status 80

HbA1c Blood Test – Product Description 80

Precision Diabetes LLC Pipeline Products & Ongoing Clinical Trials Overview 81

Precision IGT Prediabetes Test – Product Status 81

Precision IGT Prediabetes Test – Product Description 81

Protagen AG Pipeline Products & Ongoing Clinical Trials Overview 82

Diagnostic Assay – Type 1 Diabetes – Product Status 82

Diagnostic Assay – Type 1 Diabetes – Product Description 82

QSTAG Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

Qscheck – BISA1C Kit – Product Status 83

Qscheck – BISA1C Kit – Product Description 83

Queen Mary University of London Pipeline Products & Ongoing Clinical Trials Overview 84

Biomarker Assay – Type I Diabetes – Product Status 84

Biomarker Assay – Type I Diabetes – Product Description 84

QuickCheck Health Inc Pipeline Products & Ongoing Clinical Trials Overview 85

Diagnostic Test – A1c – Product Status 85

Diagnostic Test – A1c – Product Description 85

Sebia Pipeline Products & Ongoing Clinical Trials Overview 86

Capillarys 3 Tera – HbA1c Capillary Blood Assay – Product Status 86

Capillarys 3 Tera – HbA1c Capillary Blood Assay – Product Description 86

Sera Prognostics Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Biomarker Test – Gestational Diabetes Mellitus – Product Status 87

Biomarker Test – Gestational Diabetes Mellitus – Product Description 87

Singulex Inc Pipeline Products & Ongoing Clinical Trials Overview 88

SMC Adiponectin Test – Product Status 88

SMC Adiponectin Test – Product Description 88

SomaLogic Inc Pipeline Products & Ongoing Clinical Trials Overview 89

SomaSignal Test – Diabetic Status – Product Status 89

SomaSignal Test – Diabetic Status – Product Description 89

SpinChip Diagnostics AS Pipeline Products & Ongoing Clinical Trials Overview 90

SpinChip – HbA1c Assay – Product Status 90

SpinChip – HbA1c Assay – Product Description 90

Stanford University Pipeline Products & Ongoing Clinical Trials Overview 91

Diagnostic Test – Diabetes – Product Status 91

Diagnostic Test – Diabetes – Product Description 91

Sugentech Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Surearly SMART Pro HbA1c Assay – Product Status 92

Surearly SMART Pro HbA1c Assay – Product Description 92

Tetz Laboratories Pipeline Products & Ongoing Clinical Trials Overview 93

Diagnostic Test – Type 1 Diabetes – Product Status 93

Diagnostic Test – Type 1 Diabetes – Product Description 93

The Forsyth Institute Pipeline Products & Ongoing Clinical Trials Overview 94

Saliva Based Diagnostic Assay – Type 2 Diabetes – Product Status 94

Saliva Based Diagnostic Assay – Type 2 Diabetes – Product Description 94

University of Canterbury Pipeline Products & Ongoing Clinical Trials Overview 95

Low Intensity Model Based Test – Insulin Resistance – Product Status 95

Low Intensity Model Based Test – Insulin Resistance – Product Description 95

University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 96

IGRP Autoantibody Based Assay – Type-1 Diabetes – Product Status 96

IGRP Autoantibody Based Assay – Type-1 Diabetes – Product Description 96

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 97

Diagnostic Assay – Diabetes – Product Status 97

Diagnostic Assay – Diabetes – Product Description 97

Non-Invasive Test – Pancreatic Function – Product Status 98

Non-Invasive Test – Pancreatic Function – Product Description 98

University of Newcastle Pipeline Products & Ongoing Clinical Trials Overview 99

Needle-Free Diabetes Test – Product Status 99

Needle-Free Diabetes Test – Product Description 99

University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 100

Diagnostic Test – Gestational Diabetes – Product Status 100

Diagnostic Test – Gestational Diabetes – Product Description 100

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 101

Saliva Based Biomarker Assay – Diabetes – Product Status 101

Saliva Based Biomarker Assay – Diabetes – Product Description 101

University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 102

Saliva Test – Diabetes Monitoring – Product Status 102

Saliva Test – Diabetes Monitoring – Product Description 102

Vactech Oy Pipeline Products & Ongoing Clinical Trials Overview 103

Diagnostic Test – Type 1 Diabetes – Product Status 103

Diagnostic Test – Type 1 Diabetes – Product Description 103

Vital Diagnostics, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 104

Eon Hemoglobin A1c Assay – Product Status 104

Eon Hemoglobin A1c Assay – Product Description 104

Wave 80 Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 105

RAABET T1D Assay – Product Status 105

RAABET T1D Assay – Product Description 105

Xhale Inc Pipeline Products & Ongoing Clinical Trials Overview 106

Oral Glucose Tolerance Test – Product Status 106

Oral Glucose Tolerance Test – Product Description 106

Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

Diagnostic Test – Diabetes – Product Status 107

Diagnostic Test – Diabetes – Product Description 107

Yale University Pipeline Products & Ongoing Clinical Trials Overview 108

Early Detection Test – ß Cell Death – Product Status 108

Early Detection Test – ß Cell Death – Product Description 108

Glossary 119

Figures

Diabetes Assays – Pipeline Products by Stage of Development 13

Diabetes Assays – Pipeline Products by Segment 14

Diabetes Assays – Pipeline Products by Territory 15

Diabetes Assays – Pipeline Products by Regulatory Path 16

Diabetes Assays – Pipeline Products by Estimated Approval Date 17

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