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

Published : Dec-2019

No. of Pages : 403

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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
7.4 Disclaimer 403

List of Tables
Table 1: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Stage of Development 20
Table 2: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Territory 21
Table 3: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Regulatory Path 22
Table 4: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Estimated Approval Date 23
Table 5: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Ongoing Clinical Trials 24
Table 6: Clinical Chemistry Rapid Tests & Point of Care (POC) Diagnostic Tests Companies - Pipeline Products by Stage of Development 25
Table 7: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Stage of Development 28
Table 8: Abreos Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 33
Table 9: Veritope ELISA Based Immunoassay - Natalizumab - Product Status 34
Table 10: Veritope ELISA Based Immunoassay - Natalizumab - Product Description 34
Table 11: Veritope Immunoassay - Atezolizumab - Product Status 34
Table 12: Veritope Immunoassay - Atezolizumab - Product Description 36
Table 13: Veritope Immunoassay - Daratumumab - Product Status 36
Table 14: Veritope Immunoassay - Daratumumab - Product Description 36
Table 15: Veritope Immunoassay - Eculizumab - Product Status 37
Table 16: Veritope Immunoassay - Eculizumab - Product Description 37
Table 17: Veritope Immunoassay - Pertuzumab - Product Status 37
Table 18: Veritope Immunoassay - Pertuzumab - Product Description 38
Table 19: Veritope Immunoassay - Ramucirumab - Product Status 38
Table 20: Veritope Immunoassay - Ramucirumab - Product Description 38
Table 21: Veritope Immunoassay - Tocilizumab - Product Status 39
Table 22: Veritope Immunoassay - Tocilizumab - Product Description 39
Table 23: Veritope Immunoassay - Vedolizumab - Product Status 39
Table 24: Veritope Immunoassay - Vedolizumab - Product Description 40
Table 25: Veritope Lateral Flow Immunoassay - Adalimumab - Product Status 40
Table 26: Veritope Lateral Flow Immunoassay - Adalimumab - Product Description 40
Table 27: Veritope Lateral Flow Immunoassay - Alemtuzumab - Product Status 41
Table 28: Veritope Lateral Flow Immunoassay - Alemtuzumab - Product Description 41
Table 29: Veritope Lateral Flow Immunoassay - Bevacizumab - Product Status 41
Table 30: Veritope Lateral Flow Immunoassay - Bevacizumab - Product Description 42
Table 31: Veritope Lateral Flow Immunoassay - Cetuximab - Product Status 42
Table 32: Veritope Lateral Flow Immunoassay - Cetuximab - Product Description 42
Table 33: Veritope Lateral Flow Immunoassay - Infliximab - Product Status 43
Table 34: Veritope Lateral Flow Immunoassay - Infliximab - Product Description 43
Table 35: Veritope Lateral Flow Immunoassay - Ipilimumab - Product Status 43
Table 36: Veritope Lateral Flow Immunoassay - Ipilimumab - Product Description 44
Table 37: Veritope Lateral Flow Immunoassay - Nivolumab - Product Status 44
Table 38: Veritope Lateral Flow Immunoassay - Nivolumab - Product Description 44
Table 39: Veritope Lateral Flow Immunoassay - Obinutuzumab - Product Status 45
Table 40: Veritope Lateral Flow Immunoassay - Obinutuzumab - Product Description 45
Table 41: Veritope Lateral Flow Immunoassay - Pembrolizumab - Product Status 45
Table 42: Veritope Lateral Flow Immunoassay - Pembrolizumab - Product Description 46
Table 43: Veritope Lateral Flow Immunoassay - Rituximab - Product Status 46
Table 44: Veritope Lateral Flow Immunoassay - Rituximab - Product Description 46
Table 45: Veritope Lateral Flow Immunoassay - Trastuzumab - Product Status 47
Table 46: Veritope Lateral Flow Immunoassay - Trastuzumab - Product Description 47
Table 47: Acetaminophen Toxicity Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 48
Table 48: AcetaSTAT(r) - Product Status 48
Table 49: AcetaSTAT(r) - Product Description 48
Table 50: Affinergy LLC Pipeline Products & Ongoing Clinical Trials Overview 49
Table 51: Phagelock Assay - Product Status 49
Table 52: Phagelock Assay - Product Description 49
Table 53: Am Biotechnologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 50
Table 54: Thioaptamer Diagnostic System - sALP Biomarker - Product Status 50
Table 55: Thioaptamer Diagnostic System - sALP Biomarker - Product Description 50
Table 56: Thioaptamers Diagnostic System - Gpx Biomarker - Product Status 51
Table 57: Thioaptamers Diagnostic System - Gpx Biomarker - Product Description 51
Table 58: Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 52
Table 59: RFslide Latex Slide Test - Product Status 52
Table 60: RFslide Latex Slide Test - Product Description 52

List of Figures
Figure 1: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Stage of Development 18
Figure 2: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Territory 19
Figure 3: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Regulatory Path 20
Figure 4: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Pipeline Products by Estimated Approval Date 21
Figure 5: Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Ongoing Clinical Trials 22

Filed in: Pharmaceutical, Pharmaceuticals and Healthcare

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