Clinical Chemistry Rapid Tests and POC Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

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Clinical chemistry rapid tests are used in low-resource settings with the help of test strips, tablets, and solutions. Clinical chemistry PoC diagnostics are used to determine the concentration or activity of blood gas, electrolytes, metabolites, enzymes, carbohydrates, proteins, lipids, and small molecules. The Clinical Chemistry Rapid Tests and POC pipeline market research report provides comprehensive information about the Clinical Chemistry Rapid Tests and POC pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Clinical Chemistry Rapid Tests and POC Pipeline Products Market Territory Outlook

Some of the key territories with products in the pipeline are the US, Europe, South Korea, Canada, Australia, India, Jordan, Laos, Cambodia, and Vietnam. As of September 2022, the US has the highest number of products in the pipeline out of them all.

Clinical Chemistry Rapid Tests and POC Pipeline Products Market Analysis, by Territories

Clinical Chemistry Rapid Tests and POC Pipeline Products Market Analysis, by Territories

For more territory insights, download a free report sample

Clinical Chemistry Rapid Tests and POC Pipeline Products Market Segmentation by Key Regulatory Paths

The key regulatory paths followed by the Clinical Chemistry Rapid Tests and POC pipeline products market are 510(k), CE-IVD, MDITAC, MDL, ICAC, TGA, PMA, and CLIA. Most of the products follow the 510(k) pathway to enter the market.

Clinical Chemistry Rapid Tests and POC Pipeline Products Market Analysis, by Regulatory Paths

Clinical Chemistry Rapid Tests and POC Pipeline Products Market Analysis, by Regulatory Paths

For more regulatory path insights, download a free report sample

Competitive Landscape

Some of the key companies in the Clinical Chemistry Rapid Tests and POC pipeline products market are Abreos Biosciences Inc, Acetaminophen Toxicity Diagnostics, LLC, Affinergy LLC, Am Biotechnologies, LLC, AnaZyme LLC, Angle Biosciences Inc, Augurix SA, Baebies Inc, Base Pair Biotechnologies Inc, and Biocross SL.

Abreos Biosciences Inc: It is a biotechnology company engaged in the development of laboratory-based and point-of-care (POC) assays and reagents for the precision dose monitoring of biologic drugs. Abreos offers custom reagents to biopharmaceutical manufacturers and researchers for drug development life cyclepharmacokinetic studiesbio-purification and personalized dosing of biologic drugs. Abreos is headquartered in La Jolla, California, the US.

Affinergy LLC: The company develops assays and research tools to improve scientific and diagnostic outcomes. It develops a phage display platform that identifies peptides that bind to a variety of targets, such as drugs, proteins, and cells. It also offers implantable devices that deliver and retains biologics at the site of the implant in orthopedic procedures and soft tissue repair. Affinergy is headquartered in Morrisville, North Carolina, the US. 

Angle Biosciences Inc: The company is a provider of optic technology solutions. It offers technical and application support, on-site and in-house training, extended warranty, service and maintenance contracts and custom application development services. Angle Biosciences offers software for method creation, data gathering, and data analysis. It markets its products in Canada, Ireland, Belgium, Luxemburg, Spain, the Netherlands, the UK, and the US. Angle Biosciences is headquartered in Toronto, Ontario, Canada.

Clinical Chemistry Rapid Tests and POC Pipeline Products Market Report Overview

Key Territories The US, Europe, South Korea, Canada, Australia, India, Jordan, Laos, Cambodia, and Vietnam
Key Regulatory Paths 510(k), CE-IVD, MDITAC, MDL, ICAC, TGA, PMA, and CLIA
Key Companies Abreos Biosciences Inc, Acetaminophen Toxicity Diagnostics, LLC, Affinergy LLC, Am Biotechnologies, LLC, AnaZyme LLC, Angle Biosciences Inc, Augurix SA, Baebies Inc, Base Pair Biotechnologies Inc, and Biocross SL

Scope

This report provides:

  • Extensive coverage of the Clinical Chemistry Rapid Tests and POC under development.
  • Details of major pipeline products which include product description, licensing, collaboration details, and other developmental activities.
  • Reviews of the major players involved in the development of Clinical Chemistry Rapid Tests and POC and lists all their pipeline projects.
  • The 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 a potentially strong product portfolio and create effective counterstrategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Clinical Chemistry Rapid Tests and POC under development.
  • Develop market-entry and market expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Abreos Biosciences Inc
Acetaminophen Toxicity Diagnostics, LLC
Affinergy LLC
Am Biotechnologies, LLC
AnaZyme LLC
Angle Biosciences Inc
Augurix SA
Baebies Inc
Base Pair Biotechnologies Inc
Biocross SL
Bioftalmik Applied Research
Biotech Resources Aust Pty Ltd
Boditech Med Inc
Burnet Institute
Calmark Sweden AB
Cambridge Diagnostic Imaging Ltd
Carclo Diagnostic Solutions Ltd
CardioGenics Inc
Cellex Inc
Center for Biomedical Research Network in Bioengineering, Biomaterials and Nanomedicine
Claremont BioSolutions
Columbia University
DiaSys Diagnostic Systems GmbH
Edan Instruments Inc
Foundation for Innovative New Diagnostics
GlucoSentient Inc
Group K Diagnostics
Instrumentation Laboratory Co
IPI Singapore
IR2Dx Inc.
Magee-Womens Research Institute
Massachusetts Institute of Technology
Medical University of South Carolina
MiCo BioMed Co Ltd
Monash University
Montana State University
NanoSpeed Diagnostics Inc
Ohmx Corp
OPKO Health Inc
Oxford Immunotec Ltd
Pennsylvania State University
PortaScience Inc
ProciseDx LLC
Quidel Corp
SaltCheck Inc (Inactive)
Seattle Children's Hospital
SenGenix Inc
Systagenix Wound Management Ltd
The University of New South Wales press Limited
Thermo Fisher Scientific Inc
Universal Biosensors Inc
University of Edinburgh
University of Florida
University of South Australia
UrSure Inc

Table of Contents

1 Table of Contents 3

|1.1 List of Tables 8

|1.2 List of Figures 13

2 Introduction 14

2.1 Clinical Chemistry Rapid Tests & POC Overview 14

3 Products under Development 15

3.1 Clinical Chemistry Rapid Tests & POC – Pipeline Products by Stage of Development 15

3.2 Clinical Chemistry Rapid Tests & POC – Pipeline Products by Territory 16

3.3 Clinical Chemistry Rapid Tests & POC – Pipeline Products by Regulatory Path 17

3.4 Clinical Chemistry Rapid Tests & POC – Pipeline Products by Estimated Approval Date 18

3.5 Clinical Chemistry Rapid Tests & POC – Ongoing Clinical Trials 19

4 Clinical Chemistry Rapid Tests & POC – Pipeline Products under Development by Companies 20

4.1 Clinical Chemistry Rapid Tests & POC Companies – Pipeline Products by Stage of Development 20

4.2 Clinical Chemistry Rapid Tests & POC – Pipeline Products by Stage of Development 23

5 Clinical Chemistry Rapid Tests & POC Companies and Product Overview 26

5.1 Abreos Biosciences Inc Company Overview 26

5.1.1 Abreos Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.2 Acetaminophen Toxicity Diagnostics, LLC Company Overview 34

5.2.1 Acetaminophen Toxicity Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 34

5.3 Affinergy LLC Company Overview 37

5.3.1 Affinergy LLC Pipeline Products & Ongoing Clinical Trials Overview 37

5.4 Am Biotechnologies, LLC Company Overview 40

5.4.1 Am Biotechnologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 40

5.5 AnaZyme LLC Company Overview 42

5.5.1 AnaZyme LLC Pipeline Products & Ongoing Clinical Trials Overview 42

5.6 Angle Biosciences Inc Company Overview 44

5.6.1 Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.7 Augurix SA Company Overview 45

5.7.1 Augurix SA Pipeline Products & Ongoing Clinical Trials Overview 45

5.8 Baebies Inc Company Overview 46

5.8.1 Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.9 Base Pair Biotechnologies Inc Company Overview 47

5.9.1 Base Pair Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.10 Biocross SL Company Overview 48

5.10.1 Biocross SL Pipeline Products & Ongoing Clinical Trials Overview 48

5.11 Bioftalmik Applied Research Company Overview 50

5.11.1 Bioftalmik Applied Research Pipeline Products & Ongoing Clinical Trials Overview 50

5.12 Biotech Resources Aust Pty Ltd Company Overview 51

5.12.1 Biotech Resources Aust Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

5.13 Boditech Med Inc Company Overview 52

5.13.1 Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 52

5.14 Burnet Institute Company Overview 56

5.14.1 Burnet Institute Pipeline Products & Ongoing Clinical Trials Overview 56

5.15 Calmark Sweden AB Company Overview 57

5.15.1 Calmark Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 57

5.16 Cambridge Diagnostic Imaging Ltd Company Overview 60

5.16.1 Cambridge Diagnostic Imaging Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

5.17 Carclo Diagnostic Solutions Ltd Company Overview 62

5.17.1 Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

5.18 CardioGenics Inc Company Overview 64

5.18.1 CardioGenics Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.19 Cellex Inc Company Overview 65

5.19.1 Cellex Inc Pipeline Products & Ongoing Clinical Trials Overview 65

5.20 Center for Biomedical Research Network in Bioengineering, Biomaterials and Nanomedicine Company Overview 66

5.20.1 Center for Biomedical Research Network in Bioengineering, Biomaterials and Nanomedicine Pipeline Products & Ongoing Clinical Trials Overview 66

5.21 Claremont BioSolutions Company Overview 67

5.21.1 Claremont BioSolutions Pipeline Products & Ongoing Clinical Trials Overview 67

5.22 Columbia University Company Overview 68

5.22.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 68

5.23 DiaSys Diagnostic Systems GmbH Company Overview 69

5.23.1 DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 69

5.24 Edan Instruments Inc Company Overview 70

5.24.1 Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 70

5.25 Foundation for Innovative New Diagnostics Company Overview 71

5.25.1 Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 71

5.26 GlucoSentient Inc Company Overview 72

5.26.1 GlucoSentient Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.27 Group K Diagnostics Company Overview 73

5.27.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 73

5.28 Instrumentation Laboratory Co Company Overview 76

5.28.1 Instrumentation Laboratory Co Pipeline Products & Ongoing Clinical Trials Overview 76

5.29 IPI Singapore Company Overview 77

5.29.1 IPI Singapore Pipeline Products & Ongoing Clinical Trials Overview 77

5.30 IR2Dx Inc. Company Overview 78

5.30.1 IR2Dx Inc. Pipeline Products & Ongoing Clinical Trials Overview 78

5.31 Magee-Womens Research Institute Company Overview 79

5.31.1 Magee-Womens Research Institute Pipeline Products & Ongoing Clinical Trials Overview 79

5.32 Massachusetts Institute of Technology Company Overview 80

5.32.1 Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 80

5.33 Medical University of South Carolina Company Overview 81

5.33.1 Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 81

5.34 MiCo BioMed Co Ltd Company Overview 82

5.34.1 MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

5.35 Monash University Company Overview 83

5.35.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 83

5.36 Montana State University Company Overview 85

5.36.1 Montana State University Pipeline Products & Ongoing Clinical Trials Overview 85

5.37 NanoSpeed Diagnostics Inc Company Overview 86

5.37.1 NanoSpeed Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.38 Ohmx Corp Company Overview 87

5.38.1 Ohmx Corp Pipeline Products & Ongoing Clinical Trials Overview 87

5.39 OPKO Health Inc Company Overview 92

5.39.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.40 Oxford Immunotec Ltd Company Overview 93

5.40.1 Oxford Immunotec Ltd Pipeline Products & Ongoing Clinical Trials Overview 93

5.41 Pennsylvania State University Company Overview 94

5.41.1 Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview 94

5.42 PortaScience Inc Company Overview 95

5.42.1 PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 95

5.43 ProciseDx LLC Company Overview 96

5.43.1 ProciseDx LLC Pipeline Products & Ongoing Clinical Trials Overview 96

5.44 Quidel Corp Company Overview 98

5.44.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 98

5.45 SaltCheck Inc (Inactive) Company Overview 100

5.45.1 SaltCheck Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 100

5.46 Seattle Children’s Hospital Company Overview 101

5.46.1 Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 101

5.47 SenGenix Inc Company Overview 103

5.47.1 SenGenix Inc Pipeline Products & Ongoing Clinical Trials Overview 103

5.48 Systagenix Wound Management Ltd Company Overview 105

5.48.1 Systagenix Wound Management Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

5.49 The University of New South Wales press Limited Company Overview 106

5.49.1 The University of New South Wales press Limited Pipeline Products & Ongoing Clinical Trials Overview 106

5.50 Thermo Fisher Scientific Inc Company Overview 107

5.50.1 Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 107

5.51 Universal Biosensors Inc Company Overview 108

5.51.1 Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.52 University of Edinburgh Company Overview 109

5.52.1 University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 109

5.53 University of Florida Company Overview 111

5.53.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 111

5.54 University of South Australia Company Overview 112

5.54.1 University of South Australia Pipeline Products & Ongoing Clinical Trials Overview 112

5.55 UrSure Inc Company Overview 113

5.55.1 UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 113

6 Clinical Chemistry Rapid Tests & POC- Recent Developments 117

6.1 Aug 23, 2022: Surmodics to Present at Upcoming Gilmartin Emerging Growth Company Showcase Wednesday, August 31, 2022 117

6.2 Aug 11, 2022: ThermoGenesis Holdings Announces Financial Results for the Second Quarter Ended June 30, 2022 and Provides Corporate Update 117

6.3 Aug 11, 2022: Illumina Reports Financial Results for Second Quarter of Fiscal Year 2022 118

6.4 Aug 10, 2022: Volitionrx Announces Second Quarter 2022 Financial Results and Business Update 120

6.5 Aug 10, 2022: Biohit announce Half Year Financial Report

2022. 123

6.6 Aug 09, 2022: ThermoGenesis Holdings to Announce Financial Results for the Second Quarter Ended June 30, 2022 and Provide a Corporate Strategic Update 130

6.7 Aug 08, 2022: Volition appoints DXOCRO to spearhead U.S. FDA strategy 130

6.8 Aug 04, 2022: Celcuity Schedules Release of Second Quarter 2022 Financial Results and Webcast/Conference Call 131

6.9 Aug 01, 2022: Smiths Group Announce Directorate Change 131

6.10 Jul 28, 2022: Samsung Electronics Announces Second Quarter 2022 Results 131

6.11 Jul 28, 2022: Balfour Beatty teams up with Steps to Hope to raise funds for people in need 135

6.12 Jul 28, 2022: Bio-rad Reports Second-quarter 2022 Financial Results 135

6.13 Jul 28, 2022: Grifols Report EUR 2,810.1 million revenues in first half of 2022 140

6.14 Jul 25, 2022: Beckman Coulter partners with Mass General and BARDA to identify severe pediatric infections in emergency departments 142

6.15 Jul 24, 2022: Central Trust Buys 136 Shares of Novartis AG 143

6.16 Jul 20, 2022: Abbott Reports Second-Quarter 2022 Results and Raises Full-Year EPS Guidance 143

6.17 Jul 18, 2022: Bio-Rad to Report Second Quarter 2022 Financial Results on Thursday, July 28, 2022 143

6.18 Jul 14, 2022: MedMira Strengthens and Expands Board 144

6.19 Jul 12, 2022: Aspire & USF Pass $10M in ticket & donation revenue 144

6.20 Jul 01, 2022: Novartis Leaning Toward Spinoff of $25 Billion Generics Arm 145

6.21 Jun 28, 2022: Novartis to cut up to 8,000 jobs globally 145

6.22 Jun 21, 2022: Lumos Diagnostics Appoints Doug Ward As CEO 145

6.23 Jun 09, 2022: Samsung Electronics Vice Chairman Lee Flies into Germany 145

6.24 Jun 09, 2022: EKF Diagnostics Holdings : Launch of EKF Link 146

6.25 Jun 07, 2022: BD Names Simon Campion as Medical Segment President 146

6.26 Jun 02, 2022: BD to Present at Goldman Sachs 43rd Annual Global Healthcare Conference 147

6.27 Jun 01, 2022: Agilent releases IVDR-compliant instruments, kits, and reagents for use in the European Union 147

6.28 May 19, 2022: ThermoGenesis Holdings Announces Financial Results for the First Quarter Ended March 31, 2022 and Provides Corporate Update 147

6.29 May 16, 2022: Celcuity Reports First Quarter 2022 Financial Results and Business Updates 149

6.30 May 11, 2022: Babson, BD expand strategic partnership to advance diagnostic blood collection in new care settings 150

6.31 May 11, 2022: VolitionRx Announces First Quarter 2022 Financial Results and Business Update 151

6.32 May 10, 2022: Qualigen Therapeutics’ Partner NanoSynex to Present Technology at BioMed Israel 154

6.33 May 09, 2022: Samsung hires Marco Chisari as executive vice president of SSIC and foundry business in US 154

6.34 Apr 29, 2022: BD to Present at the BofA Securities 2022 Healthcare Conference 155

6.35 Apr 28, 2022: Illumina to Webcast Upcoming Investor Conference 155

6.36 Apr 25, 2022: Samsung appoints New Co-CEO for smartphone and chip manufacturing 155

6.37 Apr 25, 2022: EKF Diagnostics Holdings announces Posting of Annual Report & Accounts &Notice of AGM 155

6.38 Apr 19, 2022: Tn Antigen: Peter Mac interim development clinical study results 156

6.39 Apr 11, 2022: Thermo Fisher Scientific to Host Investor Day 157

6.40 Apr 11, 2022: John Frank Joins Illumina as Chief Public Affairs Officer 157

6.41 Apr 07, 2022: Quidel Announces Preliminary Revenue for First Quarter 2022 158

6.42 Apr 06, 2022: Volition appoints Sharon Ballesteros as U.S. Head of Quality and Development Process 158

6.43 Apr 04, 2022: Novartis appoints Shreeram Aradhye as chief medical officer 159

6.44 Apr 01, 2022: NTU Singapore researchers develop an efficient and precise motion capture system to aid in physiotherapy and athletics 159

6.45 Mar 30, 2022: VolitionRx Announces Full Fiscal Year 2021 Financial Results and Business Update 160

6.46 Mar 29, 2022: Genedrive Announces Interim results to 31 December 2021 165

6.47 Mar 28, 2022: ThermoGenesis Holdings Announces Year End 2021 Financial Results and Provides Corporate Update 165

6.48 Mar 25, 2022: Smiths Group Announce half year results for 6 months ended 31 January 2022 167

6.49 Mar 25, 2022: Smiths Group plc Half Year Results 2022 168

6.50 Mar 17, 2022: Genedrive Appoints Russell John Shaw as Chief Financial Officer 170

6.51 Mar 04, 2022: Novartis shareholders approve all resolutions proposed by the Board of Directors at the Annual General Meeting 172

6.52 Mar 03, 2022: binx health Announces Appointment of UnitedHealth Group’s Optum Rx Chief Financial Officer Jeff Grosklags to its Board of Directors 173

6.53 Mar 02, 2022: Smiths Group Director Change 173

6.54 Feb 24, 2022: BD to Present at the Cowen 42nd Annual Health Care Conference 174

6.55 Feb 23, 2022: embecta to Host Virtual Investor Event Ahead of Planned Spinoff from BD 174

6.56 Feb 23, 2022: Bd Appoints Shana Neal as Chief People Officer 174

6.57 Feb 22, 2022: Agilent Reports First-Quarter Fiscal Year 2022 Financial Results 175

6.58 Feb 15, 2022: Samsung Electronics Announce Appointment of New Chief Executive Officer 176

6.59 Feb 14, 2022: Bio-Rad Laboratories to Post Q1 2022 Earnings of $2.80 Per Share, Jefferies Financial Group Forecasts 176

6.60 Feb 11, 2022: Span Divergent Un-Audited Financial Results for the Quarter Ended 31st December 2021 176

6.61 Feb 02, 2022: Novartis Announces 2021 Financial Results 177

6.62 Feb 02, 2022: Bio-Rad to Host Investor Day on February 25 185

6.63 Jan 31, 2022: EKF Diagnostics Holdings Announces Non-executive Directorate Change 185

6.64 Jan 31, 2022: MedMira Reports Second Quarter Results FY2022 186

6.65 Jan 27, 2022: Samsung Electronics Announces Fourth Quarter and FY 2021 Results 187

6.66 Jan 19, 2022: Omega Diagnostics Group Announces Directorate Change 191

6.67 Jan 07, 2022: Samsung Electronics Announces Earnings Guidance for Fourth Quarter 2021 January 7, 2022 191

6.68 Jan 07, 2022: Samsung Electronics Announces Earnings Guidance for Fourth Quarter 2021 192

6.69 Jan 07, 2022: Quidel Announces Preliminary Revenue for Fourth Quarter 2021 192

6.70 Jan 06, 2022: BD Announces Change to Virtual 2022 Annual Meeting of Shareholders 193

6.71 Jan 05, 2022: BD to announce financial results for its first quarter of fiscal year 2022 194

6.72 Dec 23, 2021: Illumina To Webcast Upcoming Investor Conference 194

6.73 Dec 21, 2021: BD Announces Board of Directors for embecta, the Planned Spinoff of its Diabetes Care Business 194

6.74 Dec 17, 2021: MedMira appoints Thomas Bergmann to board 196

6.75 Dec 15, 2021: Trinity Biotech Announces Q3 2021 Results, the Entry Into a $81,250,000 Loan Facility to Refinance the Company’s Exchangeable Senior Notes and Agreements To Repurchase Outstanding Exchangeable Senior Notes 197

6.76 Dec 09, 2021: Samsung Electronics promotes young leaders as board member 198

6.77 Dec 07, 2021: Samsung Electronics Announces New Leadership 198

6.78 Nov 30, 2021: MedMira Reports FY2021 Fourth Quarter and Year End Financial Results 199

6.79 Nov 25, 2021: Omega Diagnostics Group Announces Interim Results for the Six Months Ended 30 September 2021 199

6.80 Nov 23, 2021: EKF Diagnostics Holdings Appoints Marc Davies as Chief Financial Officer 200

6.81 Nov 17, 2021: Genedrive notice of AGM 201

6.82 Nov 16, 2021: Genedrive Announces Directorate Change 201

6.83 Nov 12, 2021: ThermoGenesis Holdings Announces Financial Results for the Third Quarter Ended September 30, 2021, and Provides Corporate Update 201

6.84 Nov 11, 2021: General Industry Smiths Group Q1 Trading Statement FY2022Smiths Group Q1 Trading Statement FY2022 11 November 2021 Q1 Trading Statement FY2022 202

6.85 Nov 10, 2021: VolitionRx Announces Third Quarter 2021 Financial Results and Business Update 203

6.86 Nov 09, 2021: Genedrive announces Final Results 206

6.87 Nov 05, 2021: ThermoGenesis Holdings to Announce Financial Results for the Third Quarter Ended September 30, 2021 and Provide a Corporate Strategic Update 206

6.88 Nov 04, 2021: Quidel Reports Third Quarter 2021 Financial Results 207

6.89 Oct 30, 2021: MedMira Reports First Quarter Results FY2022 209

6.90 Oct 28, 2021: Samsung Electronics reports Q3 2021 results 210

6.91 Oct 26, 2021: Novartis Financial Results Q3 2021 214

6.92 Oct 26, 2021: SRI International Names Dr. David E. Parekh as CEO 214

6.93 Oct 26, 2021: BD to Host Investor Day on November 12 215

6.94 Oct 21, 2021: Columbia Provides Update on University’s Fiscal 2021 Results 215

6.95 Oct 19, 2021: Smiths Group announces Annual Financial Report 215

6.96 Oct 07, 2021: Quidel Announces Preliminary Revenue for Fiscal Third Quarter 2021 218

6.97 Sep 23, 2021: Dr. Mikael Dolsten Named to Agilent Board of Directors 219

6.98 Sep 22, 2021: Sandia Labs breaks ground on state-of-the-art Emergency Operations Center 219

6.99 Sep 14, 2021: EKF Diagnostics Holdings Announces unaudited interim results for the six months ended 30 June 2021 221

6.100 Sep 07, 2021: binx health adds Industry Leaders, Elizabeth Mora and Naomi Kelman to Board of Directors 222

6.101 Sep 01, 2021: BioMerieux announce First-Half 2021 Results 222

7 Appendix 223

7.1 Methodology 223

7.2 About GlobalData 226

7.3 Contact Us 226

7.4 Disclaimer 226

Table

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Stage of Development 15

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Territory 16

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Regulatory Path 17

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Estimated Approval Date 18

Clinical Chemistry Rapid Tests & POC – Ongoing Clinical Trials 19

Clinical Chemistry Rapid Tests & POC Companies – Pipeline Products by Stage of Development 20

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Stage of Development 23

Abreos Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Veritope ELISA Based Immunoassay – Natalizumab – Product Status 26

Veritope ELISA Based Immunoassay – Natalizumab – Product Description 27

Veritope Lateral Flow Immunoassay – Adalimumab – Product Status 27

Veritope Lateral Flow Immunoassay – Adalimumab – Product Description 27

Veritope Lateral Flow Immunoassay – Cetuximab – Product Status 28

Veritope Lateral Flow Immunoassay – Cetuximab – Product Description 28

Veritope Lateral Flow Immunoassay – Daratumumab – Product Status 28

Veritope Lateral Flow Immunoassay – Daratumumab – Product Description 29

Veritope Lateral Flow Immunoassay – Eculizumab – Product Status 29

Veritope Lateral Flow Immunoassay – Eculizumab – Product Description 29

Veritope Lateral Flow Immunoassay – Infliximab – Product Status 30

Veritope Lateral Flow Immunoassay – Infliximab – Product Description 30

Veritope Lateral Flow Immunoassay – Nivolumab – Product Status 30

Veritope Lateral Flow Immunoassay – Nivolumab – Product Description 31

Veritope Lateral Flow Immunoassay – Pertuzumab – Product Status 31

Veritope Lateral Flow Immunoassay – Pertuzumab – Product Description 31

Veritope Lateral Flow Immunoassay – Ramucirumab – Product Status 32

Veritope Lateral Flow Immunoassay – Ramucirumab – Product Description 32

Veritope Lateral Flow Immunoassay – Tocilizumab – Product Status 32

Veritope Lateral Flow Immunoassay – Tocilizumab – Product Description 33

Acetaminophen Toxicity Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 34

AcetaSTAT(r) – Product Status 34

AcetaSTAT(r) – Product Description 34

Acetaminophen Toxicity Diagnostics, LLC – Ongoing Clinical Trials Overview 35

AcetaSTAT(r) – Study to Evaluate the Performance of AcetaSTAT Rapid Assay for Diagnosis of Acetaminophen Liver Injury 36

Affinergy LLC Pipeline Products & Ongoing Clinical Trials Overview 37

EVR TDM Assay – Product Status 37

EVR TDM Assay – Product Description 37

Point-Of-Care Lateral Flow Assay – Tacrolimus – Product Status 38

Point-Of-Care Lateral Flow Assay – Tacrolimus – Product Description 38

Point-Of-Care Lateral Flow Assay – Vancomycin – Product Status 38

Point-Of-Care Lateral Flow Assay – Vancomycin – Product Description 39

Am Biotechnologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 40

Thioaptamer Diagnostic System – sALP Biomarker – Product Status 40

Thioaptamer Diagnostic System – sALP Biomarker – Product Description 40

Thioaptamers Diagnostic System – Gpx Biomarker – Product Status 41

Thioaptamers Diagnostic System – Gpx Biomarker – Product Description 41

AnaZyme LLC Pipeline Products & Ongoing Clinical Trials Overview 42

Blood-Based Assay – Absence Of Specific Compounds – Product Status 42

Blood-Based Assay – Absence Of Specific Compounds – Product Description 42

Blood-Based Assay – Specific Enzymes – Product Status 43

Blood-Based Assay – Specific Enzymes – Product Description 43

Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Point-Of-Care Diagnostic Test – TBI – Product Status 44

Point-Of-Care Diagnostic Test – TBI – Product Description 44

Augurix SA Pipeline Products & Ongoing Clinical Trials Overview 45

AUG-POC5 – Product Status 45

AUG-POC5 – Product Description 45

Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 46

FINDER – Product Status 46

FINDER – Product Description 46

Base Pair Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Point-of-Care Tuberculosis Measurement System – Product Status 47

Point-of-Care Tuberculosis Measurement System – Product Description 47

Biocross SL Pipeline Products & Ongoing Clinical Trials Overview 48

AD Dementia Test – Product Status 48

AD Dementia Test – Product Description 48

Degenerative Dementia Test – Product Status 49

Degenerative Dementia Test – Product Description 49

Bioftalmik Applied Research Pipeline Products & Ongoing Clinical Trials Overview 50

Diagnostic Test – Pediatric Ocular Allergy – Product Status 50

Diagnostic Test – Pediatric Ocular Allergy – Product Description 50

Biotech Resources Aust Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

ATR-FTIR System – Glucose and Urea – Product Status 51

ATR-FTIR System – Glucose and Urea – Product Description 51

Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Ichroma 10 – Anti-Infliximab Assay – Product Status 52

Ichroma 10 – Anti-Infliximab Assay – Product Description 53

Ichroma 10 – Infliximab Assay – Product Status 53

Ichroma 10 – Infliximab Assay – Product Description 53

Ichroma II – Anti-Infliximab Assay – Product Status 54

Ichroma II – Anti-Infliximab Assay – Product Description 54

Ichroma III – Anti-Infliximab Assay – Product Status 54

Ichroma III – Anti-Infliximab Assay – Product Description 55

Ichroma III – Infliximab Assay – Product Status 55

Ichroma III – Infliximab Assay – Product Description 55

Burnet Institute Pipeline Products & Ongoing Clinical Trials Overview 56

G6PD POC Diagnostic Test – Product Status 56

G6PD POC Diagnostic Test – Product Description 56

Calmark Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 57

Neo – Glucose – Product Status 57

Neo – Glucose – Product Description 57

Neo – LDH – Product Status 58

Neo – LDH – Product Description 58

Neo-Bilirubin – Product Status 58

Neo-Bilirubin – Product Description 59

Cambridge Diagnostic Imaging Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

OCCL Pregnancy Health Test – Product Status 60

OCCL Pregnancy Health Test – Product Description 60

OCCL Test – Product Status 61

OCCL Test – Product Description 61

Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

Micropoc-CAT – Haemotology Assay – Product Status 62

Micropoc-CAT – Haemotology Assay – Product Description 62

Micropoc-CAT – Inflammation Assay – Product Status 63

Micropoc-CAT – Inflammation Assay – Product Description 63

CardioGenics Inc Pipeline Products & Ongoing Clinical Trials Overview 64

Plasminogen Activator Inhibitor Type-1 Test – Product Status 64

Plasminogen Activator Inhibitor Type-1 Test – Product Description 64

Cellex Inc Pipeline Products & Ongoing Clinical Trials Overview 65

Point-Of-Care Test – Bacterial Vaginosis – Product Status 65

Point-Of-Care Test – Bacterial Vaginosis – Product Description 65

Center for Biomedical Research Network in Bioengineering, Biomaterials and Nanomedicine Pipeline Products & Ongoing Clinical Trials Overview 66

Antibody Based Diagnostic Assay – Anticoagulants – Product Status 66

Antibody Based Diagnostic Assay – Anticoagulants – Product Description 66

Claremont BioSolutions Pipeline Products & Ongoing Clinical Trials Overview 67

Integrated Disposable Assay – Clostridium Difficile – Product Status 67

Integrated Disposable Assay – Clostridium Difficile – Product Description 67

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 68

Diagnostic Test – Periodontal Disease – Product Status 68

Diagnostic Test – Periodontal Disease – Product Description 68

DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 69

Point-Of-Care Diagnostic Assay – CRP – Product Status 69

Point-Of-Care Diagnostic Assay – CRP – Product Description 69

Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 70

i15 – BUN/Urea and Creatinine Test – Product Status 70

i15 – BUN/Urea and Creatinine Test – Product Description 70

Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 71

Protein Antigen Capture Assay – Buruli Ulcer – Product Status 71

Protein Antigen Capture Assay – Buruli Ulcer – Product Description 71

GlucoSentient Inc Pipeline Products & Ongoing Clinical Trials Overview 72

Point-Of-Care Screening Assay – Therapeutic Drug Monitoring – Product Status 72

Point-Of-Care Screening Assay – Therapeutic Drug Monitoring – Product Description 72

Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 73

KromaHealth Kit – Comprehensive Metabolic Panel Test – Product Status 73

KromaHealth Kit – Comprehensive Metabolic Panel Test – Product Description 73

KromaHealth Kit – Lipid Panel – Product Status 74

KromaHealth Kit – Lipid Panel – Product Description 74

Multidiagnostic – Electrolytes Test – Product Status 74

Multidiagnostic – Electrolytes Test – Product Description 75

Multidiagnostic – Lactate Test – Product Status 75

Multidiagnostic – Lactate Test – Product Description 75

Instrumentation Laboratory Co Pipeline Products & Ongoing Clinical Trials Overview 76

POC Enzymatic Creatinine Assay – Product Status 76

POC Enzymatic Creatinine Assay – Product Description 76

IPI Singapore Pipeline Products & Ongoing Clinical Trials Overview 77

Diagnostic Test – Pneumonia – Product Status 77

Diagnostic Test – Pneumonia – Product Description 77

IR2Dx Inc. Pipeline Products & Ongoing Clinical Trials Overview 78

Drug Response Panel – Product Status 78

Drug Response Panel – Product Description 78

Magee-Womens Research Institute Pipeline Products & Ongoing Clinical Trials Overview 79

Point-Of-Care Test – HIV – Product Status 79

Point-Of-Care Test – HIV – Product Description 79

Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 80

Paper Test Strip – Blood Clots – Product Status 80

Paper Test Strip – Blood Clots – Product Description 80

Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 81

Point-Of-Care Diagnostic Test – Cardiac Resynchronization Therapy – Product Status 81

Point-Of-Care Diagnostic Test – Cardiac Resynchronization Therapy – Product Description 81

MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

Labchip Based Test – Glucose – Product Status 82

Labchip Based Test – Glucose – Product Description 82

Monash University Pipeline Products & Ongoing Clinical Trials Overview 83

Bilirubin Test – Product Status 83

Bilirubin Test – Product Description 83

Paper Test – Jaundice – Product Status 84

Paper Test – Jaundice – Product Description 84

Montana State University Pipeline Products & Ongoing Clinical Trials Overview 85

Whole Blood Cholinesterase Assay – Product Status 85

Whole Blood Cholinesterase Assay – Product Description 85

NanoSpeed Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 86

Test4T – Thyroid Profile Test – Product Status 86

Test4T – Thyroid Profile Test – Product Description 86

Ohmx Corp Pipeline Products & Ongoing Clinical Trials Overview 87

Diagnostic Test – Lactate – Product Status 87

Diagnostic Test – Lactate – Product Description 87

Portable POC System – AST – Product Status 88

Portable POC System – AST – Product Description 88

Portable POC System – Glucose – Product Status 88

Portable POC System – Glucose – Product Description 89

Portable POC System – Hemoglobin A1c – Product Status 89

Portable POC System – Hemoglobin A1c – Product Description 89

Portable POC System – Hepatic Function – Product Status 90

Portable POC System – Hepatic Function – Product Description 90

Portable POC System – Lipid – Product Status 90

Portable POC System – Lipid – Product Description 91

Portable POC System – PT-INR – Product Status 91

Portable POC System – PT-INR – Product Description 91

OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Diagnostic Assay – Pre-term Bleed – Product Status 92

Diagnostic Assay – Pre-term Bleed – Product Description 92

Oxford Immunotec Ltd Pipeline Products & Ongoing Clinical Trials Overview 93

Diagnostic Test – Homocysteine – Product Status 93

Diagnostic Test – Homocysteine – Product Description 93

Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview 94

Antibody-Based Dipstick Assay – ACTS – Product Status 94

Antibody-Based Dipstick Assay – ACTS – Product Description 94

PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 95

PortaTBili – Product Status 95

PortaTBili – Product Description 95

ProciseDx LLC Pipeline Products & Ongoing Clinical Trials Overview 96

FRET Instrument – Adalimumab Test – Product Status 96

FRET Instrument – Adalimumab Test – Product Description 96

FRET Instrument – Infliximab Test – Product Status 97

FRET Instrument – Infliximab Test – Product Description 97

Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 98

Sofia – fFN – Product Status 98

Sofia – fFN – Product Description 98

Sofia – PROM – Product Status 99

Sofia – PROM – Product Description 99

SaltCheck Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 100

Salt Intake Monitoring Test – Product Status 100

Salt Intake Monitoring Test – Product Description 100

Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 101

Diagnostic Test – Newborns – Product Status 101

Diagnostic Test – Newborns – Product Description 102

SenGenix Inc Pipeline Products & Ongoing Clinical Trials Overview 103

Diagnostic Test – Basic Metabolic Panel – Product Status 103

Diagnostic Test – Basic Metabolic Panel – Product Description 103

Point-of-Care Diagnostic Test – Creatinine – Product Status 104

Point-of-Care Diagnostic Test – Creatinine – Product Description 104

Systagenix Wound Management Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

Point-Of-Care Test – Tissue Oxygenation – Product Status 105

Point-Of-Care Test – Tissue Oxygenation – Product Description 105

The University of New South Wales press Limited Pipeline Products & Ongoing Clinical Trials Overview 106

Point of Care Test – Inflammatory Bowel Disease – Product Status 106

Point of Care Test – Inflammatory Bowel Disease – Product Description 106

Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 107

Point-Of-Care Platform – Therapeutic Drug Monitoring – Product Status 107

Point-Of-Care Platform – Therapeutic Drug Monitoring – Product Description 107

Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 108

C-Reactive Protein Test – Product Status 108

C-Reactive Protein Test – Product Description 108

University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 109

Factor H Diagnostic Test – Product Status 109

Factor H Diagnostic Test – Product Description 109

Sensor Strip Test – Product Status 110

Sensor Strip Test – Product Description 110

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 111

Sensor Strip – Cerebrospinal Fluid Leaks – Product Status 111

Sensor Strip – Cerebrospinal Fluid Leaks – Product Description 111

University of South Australia Pipeline Products & Ongoing Clinical Trials Overview 112

Point-Of-Care Wound Diagnostic Assay – Product Status 112

Point-Of-Care Wound Diagnostic Assay – Product Description 112

UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 113

UrSure POC Dolutegravir Adherence Test – Product Status 113

UrSure POC Dolutegravir Adherence Test – Product Description 113

UrSure POC Tenofovir Adherence Test – Product Status 114

UrSure POC Tenofovir Adherence Test – Product Description 114

UrSure Inc – Ongoing Clinical Trials Overview 115

UrSure POC Tenofovir Adherence Test – IPrEP: A Combination HIV Prevention Strategy for Young Women at Risk for HIV in Kisumu, Kenya IPrEP Men’s Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya 116

Glossary 225

Figures

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Stage of Development 15

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Territory 16

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Regulatory Path 17

Clinical Chemistry Rapid Tests & POC – Pipeline Products by Estimated Approval Date 18

Clinical Chemistry Rapid Tests & POC – Ongoing Clinical Trials 19

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