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

GlobalData
403 Pages - GLDATA68988
$4,000.00

Summary

GlobalData's Medical Devices sector report, “Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests - Medical Devices Pipeline Assessment, 2019" provides an overview of Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests under development
- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
- The report reviews the major players involved in the development of Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests and list all their pipeline projects
- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
- The report provides 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 potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of Clinical Chemistry Rapid Tests & Point-of-Care (POC) Diagnostic Tests 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

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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

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