Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Medical Devices Pipeline Assessment, 2019

Table of Contents

• 1.1 List of Tables 10
• 1.2 List of Figures 16

2 Introduction 17

• 2.1 Clinical Chemistry Rapid Tests & Point of Care (POC) Diagnostic Tests Overview 17

3 Products under Development 18

• 3.1 Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Stage of Development 18
• 3.2 Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Territory 19
• 3.3 Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Regulatory Path 20
• 3.4 Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Estimated Approval Date 21
• 3.5 Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Ongoing Clinical Trials 22

4 Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products under Development by Companies 23

• 4.1 Clinical Chemistry Rapid Tests & Point of Care (POC) Diagnostic Tests Companies - Pipeline Products by Stage of Development 23
• 4.2 Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Stage of Development 26

5 Clinical Chemistry Rapid Tests & Point of Care (POC) Diagnostic Tests Companies and Product Overview 30

• 5.1 Abreos Biosciences Inc Company Overview 30
  • 5.1.1 Abreos Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 30
• 5.2 Acetaminophen Toxicity Diagnostics, LLC Company Overview 44
  • 5.2.1 Acetaminophen Toxicity Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 44
• 5.3 Affinergy LLC Company Overview 45
  • 5.3.1 Affinergy LLC Pipeline Products & Ongoing Clinical Trials Overview 45
• 5.4 Am Biotechnologies, LLC Company Overview 46
  • 5.4.1 Am Biotechnologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 46
• 5.5 Analyticon Biotechnologies AG Company Overview 48
  • 5.5.1 Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 48
• 5.6 AnaZyme, LLC Company Overview 50
  • 5.6.1 AnaZyme, LLC Pipeline Products & Ongoing Clinical Trials Overview 50
• 5.7 Angle Biosciences Inc Company Overview 52
  • 5.7.1 Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 52
• 5.8 Atonomics A/S Company Overview 53
  • 5.8.1 Atonomics A/S Pipeline Products & Ongoing Clinical Trials Overview 53
• 5.9 Augurix SA Company Overview 54
  • 5.9.1 Augurix SA Pipeline Products & Ongoing Clinical Trials Overview 54
• 5.10 Baebies Inc Company Overview 55
  • 5.10.1 Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 55
• 5.11 Biocross SL Company Overview 58
  • 5.11.1 Biocross SL Pipeline Products & Ongoing Clinical Trials Overview 58
• 5.12 Bioftalmik Applied Research Company Overview 60
  • 5.12.1 Bioftalmik Applied Research Pipeline Products & Ongoing Clinical Trials Overview 60
• 5.13 BioMedomics Inc Company Overview 61
  • 5.13.1 BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 61
• 5.14 Biotech Resources Pty Ltd Company Overview 63
  • 5.14.1 Biotech Resources Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 63
• 5.15 Burnet Institute Company Overview 64
  • 5.15.1 Burnet Institute Pipeline Products & Ongoing Clinical Trials Overview 64
• 5.16 Carclo Diagnostic Solutions Ltd Company Overview 65
  • 5.16.1 Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 65
• 5.17 CardioGenics Inc Company Overview 67
  • 5.17.1 CardioGenics Inc Pipeline Products & Ongoing Clinical Trials Overview 67
• 5.18 Cellex Inc. Company Overview 70
  • 5.18.1 Cellex Inc. Pipeline Products & Ongoing Clinical Trials Overview 70
• 5.19 Centro de Investigacion Biomedica en Red en Bioingenieria Biomateriales y Nanomedicina Company Overview 71
  • 5.19.1 Centro de Investigacion Biomedica en Red en Bioingenieria Biomateriales y Nanomedicina Pipeline Products & Ongoing Clinical Trials Overview 71
• 5.20 Claremont BioSolutions Company Overview 72
  • 5.20.1 Claremont BioSolutions Pipeline Products & Ongoing Clinical Trials Overview 72
• 5.21 Columbia University Company Overview 73
  • 5.21.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 73
• 5.22 CTK Biotech, Inc. Company Overview 75
  • 5.22.1 CTK Biotech, Inc. Pipeline Products & Ongoing Clinical Trials Overview 75
• 5.23 DiaSys Diagnostic Systems GmbH Company Overview 76
  • 5.23.1 DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 76
• 5.24 Edan Instruments Inc Company Overview 78
  • 5.24.1 Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 78
• 5.25 Enesi Pharma Ltd Company Overview 80
  • 5.25.1 Enesi Pharma Ltd Pipeline Products & Ongoing Clinical Trials Overview 80
• 5.26 Enigma Diagnostics Ltd (Inactive) Company Overview 81
  • 5.26.1 Enigma Diagnostics Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 81
• 5.27 Erytech Pharma SA Company Overview 82
  • 5.27.1 Erytech Pharma SA Pipeline Products & Ongoing Clinical Trials Overview 82
• 5.28 FK-Biotecnologia SA Company Overview 83
  • 5.28.1 FK-Biotecnologia SA Pipeline Products & Ongoing Clinical Trials Overview 83
• 5.29 Foundation for Innovative New Diagnostics Company Overview 86
  • 5.29.1 Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 86
• 5.30 Gendiag Company Overview 87
  • 5.30.1 Gendiag Pipeline Products & Ongoing Clinical Trials Overview 87
• 5.31 Group K Diagnostics Company Overview 88
  • 5.31.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 88
• 5.32 Instrumentation Laboratory Co Company Overview 91
  • 5.32.1 Instrumentation Laboratory Co Pipeline Products & Ongoing Clinical Trials Overview 91
• 5.33 Integrated Diagnostics Inc (Inactive) Company Overview 92
  • 5.33.1 Integrated Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 92
• 5.34 IntraMed Diagnostics, LLC Company Overview 93
  • 5.34.1 IntraMed Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 93
• 5.35 IPI Singapore Company Overview 95
  • 5.35.1 IPI Singapore Pipeline Products & Ongoing Clinical Trials Overview 95
• 5.36 Iron Horse Diagnostics, Inc. Company Overview 96
  • 5.36.1 Iron Horse Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 96
• 5.37 Kenyatta University Company Overview 97
  • 5.37.1 Kenyatta University Pipeline Products & Ongoing Clinical Trials Overview 97
• 5.38 Massachusetts Institute of Technology Company Overview 98
  • 5.38.1 Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 98
• 5.39 Medical University of South Carolina Company Overview 100
  • 5.39.1 Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 100
• 5.40 Monash University Company Overview 101
  • 5.40.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 101
• 5.41 Montana State University Company Overview 102
  • 5.41.1 Montana State University Pipeline Products & Ongoing Clinical Trials Overview 102
• 5.42 NanoSpeed Diagnostics Inc Company Overview 103
  • 5.42.1 NanoSpeed Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 103
• 5.43 Novartis AG Company Overview 106
  • 5.43.1 Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 106
• 5.44 Oasis Diagnostics Corp Company Overview 109
  • 5.44.1 Oasis Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 109
• 5.45 Ohmx Corp Company Overview 110
  • 5.45.1 Ohmx Corp Pipeline Products & Ongoing Clinical Trials Overview 110
• 5.46 OPKO Health Inc Company Overview 115
  • 5.46.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 115
• 5.47 Oxford Immunotec Ltd Company Overview 117
  • 5.47.1 Oxford Immunotec Ltd Pipeline Products & Ongoing Clinical Trials Overview 117
• 5.48 P2D Inc Company Overview 118
  • 5.48.1 P2D Inc Pipeline Products & Ongoing Clinical Trials Overview 118
• 5.49 Philips Healthcare Company Overview 120
  • 5.49.1 Philips Healthcare Pipeline Products & Ongoing Clinical Trials Overview 120
• 5.50 Pop Test LLC Company Overview 121
  • 5.50.1 Pop Test LLC Pipeline Products & Ongoing Clinical Trials Overview 121
• 5.51 PortaScience Inc Company Overview 123
  • 5.51.1 PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 123
• 5.52 Quidel Corp Company Overview 124
  • 5.52.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 124
• 5.53 SaltCheck Inc (Inactive) Company Overview 126
  • 5.53.1 SaltCheck Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 126
• 5.54 Seattle Children's Hospital Company Overview 127
  • 5.54.1 Seattle Children's Hospital Pipeline Products & Ongoing Clinical Trials Overview 127
• 5.55 SenGenix Inc Company Overview 128
  • 5.55.1 SenGenix Inc Pipeline Products & Ongoing Clinical Trials Overview 128
• 5.56 SuperNova Diagnostics, Inc. Company Overview 130
  • 5.56.1 SuperNova Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 130
• 5.57 Systagenix Wound Management Ltd Company Overview 131
  • 5.57.1 Systagenix Wound Management Ltd Pipeline Products & Ongoing Clinical Trials Overview 131
• 5.58 The University of New South Wales press Limited Company Overview 132
  • 5.58.1 The University of New South Wales press Limited Pipeline Products & Ongoing Clinical Trials Overview 132
• 5.59 Thermo Fisher Scientific Inc Company Overview 133
  • 5.59.1 Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 133
• 5.60 Trivitron Healthcare Pvt Ltd Company Overview 134
  • 5.60.1 Trivitron Healthcare Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 134
• 5.61 True Diagnostics Inc Company Overview 135
  • 5.61.1 True Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 135
• 5.62 Universal Biosensors Inc Company Overview 136
  • 5.62.1 Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 136
• 5.63 University College Cork Company Overview 137
  • 5.63.1 University College Cork Pipeline Products & Ongoing Clinical Trials Overview 137
• 5.64 University of Edinburgh Company Overview 138
  • 5.64.1 University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 138
• 5.65 University of South Australia Company Overview 140
  • 5.65.1 University of South Australia Pipeline Products & Ongoing Clinical Trials Overview 140
• 5.66 Wellstat Diagnostics LLC Company Overview 141
  • 5.66.1 Wellstat Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 141

6 Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Recent Developments 142

• 6.1 Nov 12, 2019: VolitionRx announces third quarter 2019 financial results and business update 142
• 6.2 Nov 07, 2019: Celcuity reports third quarter 2019 financial results 143
• 6.3 Nov 05, 2019: Thermo Fisher Scientific highlights expanded pharma services capabilities during CPhI 145
• 6.4 Nov 05, 2019: BD announces results for 2019 fourth fiscal quarter and full year; provides fiscal 2020 guidance 146
• 6.5 Nov 05, 2019: OPKO Health reports 2019 third quarter business highlights and financial results 148
• 6.6 Oct 31, 2019: Cesca Therapeutics to change name and ticker symbol to reflect new strategic focus 149
• 6.7 Oct 31, 2019: Bio-Rad reports third-quarter 2019 financial results 150
• 6.8 Oct 31, 2019: Surmodics reports fourth quarter fiscal 2019 results and issues fiscal 2020 revenue and EPS Guidance 151
• 6.9 Oct 31, 2019: Bio-Rad reports third-quarter 2019 financial results. 152
• 6.10 Oct 30, 2019: Quidel reports third quarter 2019 financial results 153

7 Appendix 400

• 7.1 Methodology 400
• 7.2 About GlobalData 403
• 7.3 Contact Us 403