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Clinical Chemistry Analyzers-Medical Devices Pipeline Assessment, 2017

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Clinical Chemistry Analyzers-Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, "Clinical Chemistry Analyzers-Medical Devices Pipeline Assessment, 2017" provides an overview of Clinical Chemistry Analyzers 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 Analyzers 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 Analyzers 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 Analyzers 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 Analyzers 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

READ MORE

Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 9

2.1 Clinical Chemistry Analyzers Overview 9

3 Products under Development 10

3.1 Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 10

3.2 Clinical Chemistry Analyzers-Pipeline Products by Segment 11

3.3 Clinical Chemistry Analyzers-Pipeline Products by Territory 12

3.4 Clinical Chemistry Analyzers-Pipeline Products by Regulatory Path 13

3.5 Clinical Chemistry Analyzers-Pipeline Products by Estimated Approval Date 14

3.6 Clinical Chemistry Analyzers-Ongoing Clinical Trials 15

4 Clinical Chemistry Analyzers-Pipeline Products under Development by Companies 16

4.1 Clinical Chemistry Analyzers Companies-Pipeline Products by Stage of Development 16

4.2 Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 18

5 Clinical Chemistry Analyzers Companies and Product Overview 19

5.1 All Medicus Co Ltd Company Overview 19

5.1.1 All Medicus Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 19

5.2 Analyticon Biotechnologies AG Company Overview 20

5.2.1 Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 20

5.3 Ativa Medical Inc Company Overview 23

5.3.1 Ativa Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.4 Aviv Biomedical, Inc. Company Overview 24

5.4.1 Aviv Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

5.5 Beckman Coulter Inc Company Overview 25

5.5.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.6 Curetis NV Company Overview 26

5.6.1 Curetis NV Pipeline Products & Ongoing Clinical Trials Overview 26

5.7 Daxor Corp Company Overview 28

5.7.1 Daxor Corp Pipeline Products & Ongoing Clinical Trials Overview 28

5.8 DiaSys Diagnostic Systems GmbH Company Overview 29

5.8.1 DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 29

5.9 Emergent Detection Inc (Inactive) Company Overview 31

5.9.1 Emergent Detection Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

5.10 Hansjorg Wyss Institute for Biologically Inspired Engineering Company Overview 32

5.10.1 Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 32

5.11 Illumina, Inc. Company Overview 33

5.11.1 Illumina, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.12 Instrumentation Laboratory Company Company Overview 35

5.12.1 Instrumentation Laboratory Company Pipeline Products & Ongoing Clinical Trials Overview 35

5.13 Invivomon Inc (Inactive) Company Overview 38

5.13.1 Invivomon Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 38

5.14 I-Sens Inc Company Overview 39

5.14.1 I-Sens Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.15 MyCartis NV Company Overview 40

5.15.1 MyCartis NV Pipeline Products & Ongoing Clinical Trials Overview 40

5.16 NanoIVD Inc Company Overview 41

5.16.1 NanoIVD Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.17 National Institute of Biomedical Imaging and Bioengineering Company Overview 42

5.17.1 National Institute of Biomedical Imaging and Bioengineering Pipeline Products & Ongoing Clinical Trials Overview 42

5.18 NeuMoDx Molecular, Inc Company Overview 43

5.18.1 NeuMoDx Molecular, Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.19 OPKO Health Inc Company Overview 44

5.19.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.20 Samsung Electronics Co., Ltd. Company Overview 47

5.20.1 Samsung Electronics Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 47

5.21 Smiths Detection Group Limited Company Overview 49

5.21.1 Smiths Detection Group Limited Pipeline Products & Ongoing Clinical Trials Overview 49

5.22 The Hong Kong University of Science and Technology Company Overview 50

5.22.1 The Hong Kong University of Science and Technology Pipeline Products & Ongoing Clinical Trials Overview 50

5.23 Theranos Inc Company Overview 51

5.23.1 Theranos Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.24 Thermal Gradient Inc Company Overview 52

5.24.1 Thermal Gradient Inc Pipeline Products & Ongoing Clinical Trials Overview 52

6 Clinical Chemistry Analyzers-Recent Developments 53

6.1 Jul 26, 2017: Thermo Fisher Scientific Reports Second Quarter 2017 Results 53

6.2 Jul 25, 2017: Cologuard revenue increased to $57.6 million during second quarter; Test volume grew 149 percent from second quarter of 2016 to 135,000 completed tests 54

6.3 Jul 25, 2017: ERBA Diagnostics Appoints David Barka as Interim Chief Executive Officer, Nikhil Vazirani as Member of the Board 55

6.4 Jul 20, 2017: bioMerieux-Second-Quarter 2017 Business Review 56

6.5 Jul 20, 2017: Abbott Reports Second-Quarter 2017 Results 58

6.6 Jul 11, 2017: Promega First to Achieve Third-Party Certification of Published ISO 18385 Manufacturing Standard to Minimize Risk of Human DNA Contamination in Forensic Products 60

6.7 Jul 06, 2017: Kurt H. Kruger joins Qualigen's Board of Directors 61

6.8 Jul 06, 2017: Richard David, MD, FACS joins Qualigen's Board of Directors 61

6.9 Jul 03, 2017: Premaitha Health Litigation Update 62

6.10 Jun 29, 2017: Sphere Medical confirms compatibility of Proxima bedside blood gas monitoring system with leading global monitoring company 62

6.11 Jun 29, 2017: MSP bodmann appointed as new distributor in Germany 63

6.12 Jun 14, 2017: Alere Reports First Quarter 2017 Financial Results 63

6.13 Jun 13, 2017: FlowJo and BD to Provide Cloud Platform for Real-Time Single-Cell Marketing Collaboration 64

6.14 Jun 12, 2017: New Immobilized Lux Chiral LC-SFC Selector from Phenomenex Delivers Broad Enantioselectivity 65

6.15 Jun 06, 2017: BD Releases 2016 Sustainability Report 65

6.16 Jun 05, 2017: Alere Files Form 10-K, Reports Fourth Quarter and Full Year 2016 Financial Results 66

6.17 May 31, 2017: Daxor Announces Hiring of Chief Financial Officer 66

6.18 May 24, 2017: Curetis Provides Business and Financial Update for the First Quarter 2017 67

6.19 May 22, 2017: Illumina Names Mark Van Oene Chief Commercial Officer, Sales Leader Brings Genomics Expertise and Strong Commercial Leadership Experience to the Role 69

6.20 May 22, 2017: Alere Provides Preliminary Unaudited Financial Results 69

6.21 May 16, 2017: Boule Diagnostics optimizes the manufacturing structure-shuts down the Chinese production facility 70

6.22 May 16, 2017: Akers Biosciences Announces Q1 2017 Earnings 70

6.23 May 11, 2017: Boule Diagnostics: interim report January-March 2017 72

6.24 May 09, 2017: OPKO Health Reports 2016 Financial and Operating Results 73

6.25 May 04, 2017: Siemens: Earnings Release and Financial Results Q2 FY 2017: Another strong quarter-profitable growth continuing 74

6.26 May 04, 2017: PerkinElmer Announces Financial Results for the First Quarter of 2017 76

6.27 May 04, 2017: Bio-Rad Reports First-Quarter 2017 Financial Results 77

6.28 May 02, 2017: BD Announces Results For 2017 Second Fiscal Quarter 78

6.29 May 02, 2017: QIAGEN reports results for first quarter 2017 80

6.30 May 01, 2017: Luminex Reports Record First Quarter 2017 Financial Results; Raises 2017 Financial Guidance 83

6.31 Apr 28, 2017: IDEXX Laboratories Announces First Quarter Results-2017 83

6.32 Apr 27, 2017: Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2017 and Declares Quarterly Cash Dividend 86

6.33 Apr 26, 2017: Thermo Fisher Scientific Reports First Quarter 2017 Results 87

6.34 Apr 25, 2017: Illumina Reports Financial Results for First Quarter of Fiscal Year 2017 88

6.35 Apr 23, 2017: BD Announces Appointment Of Tom Polen As President 90

6.36 Apr 20, 2017: bioMerieux-First-Quarter 2017 Business Review 90

6.37 Apr 19, 2017: Abbott Reports First-Quarter 2017 Results 93

6.38 Apr 17, 2017: Toshiba Medical Names Dan Skyba Director of Ultrasound Business Unit 95

6.39 Apr 12, 2017: Curetis Reports Full-Year 2016 Financial Results and Updates 2017 Guidance 96

6.40 Apr 12, 2017: Curetis Expands Supervisory and Medical Advisory Boards 97

6.41 Apr 11, 2017: Akers Bioscience: Financial Results for the Year Ended December 31, 2016 98

6.42 Apr 11, 2017: Akers Biosciences Reports Earnings for Fiscal Year 2016 99

6.43 Apr 06, 2017: Curetis Starts Subsidiary Ares Genetics to Advance Genetic Antibiotic Resistance Testing 103

6.44 Apr 03, 2017: Supervisory Board of Siemens Healthineers ensures management continuity 105

6.45 Apr 01, 2017: New Release of H30 Fully Automated Hematology Analyzer 105

6.46 Mar 31, 2017: HORIBA Instruments commences operations at new factory in Houston 105

6.47 Mar 30, 2017: Akers Biosciences Reports Preliminary Unaudited Earnings Highlights for Fiscal Year 2016 106

6.48 Mar 28, 2017: BD Announces Success of Helping Build Healthy Communities Program, Launches New Effort Focused on Medication Therapy Management 108

6.49 Mar 27, 2017: Boule Diagnostics increases focus on Indonesia-Receives grant from Swedfund 108

6.50 Mar 23, 2017: PerkinElmer to Display Portfolio of Cancer Research Technologies and Workflow Solutions at 2017 AACR Annual Meeting 109

6.51 Mar 21, 2017: Retractable Technologies Announces Litigation Updates 110

6.52 Mar 20, 2017: EKF Diagnostics Holdings: Final results 111

6.53 Mar 17, 2017: Eva Schulz-Kamm appointed global head of Government Affairs at Siemens 111

6.54 Mar 14, 2017: Hospital ICU study demonstrates significant reduction in time to blood gas result using Sphere Medicals Proxima 111

6.55 Mar 13, 2017: Bio-Rad Intends to Propose Three New Independent Directors 112

6.56 Mar 13, 2017: Bio-Rad Initiates Long Term Financial Guidance; Commits to Defining Long Term Capital Allocation Targets and Hosting an Annual Investor Day 113

6.57 Mar 09, 2017: Alere Provides Update on Arriva Medical 114

6.58 Mar 07, 2017: Beckman Coulter Diagnostics Receives FDA Clearance for its DxC 700 AU Chemistry Analyzer 115

6.59 Mar 03, 2017: OPKO Health Appoints Dr. Akhtar Ashfaq as Renal Division Senior Vice President, Clinical Research and Development 115

6.60 Mar 01, 2017: OPKO Health Reports 2016 Financial and Operating Results 116

6.61 Mar 01, 2017: Thermo Fisher Scientific Elects New Director to Board 117

6.62 Feb 23, 2017: VBio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 118

6.63 Feb 23, 2017: Bio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 120

6.64 Feb 23, 2017: Renishaw exhibiting at BioWales 2017 122

6.65 Feb 20, 2017: Illumina Names John W. Thompson to Its Board of Directors, Bringing More Than 40 Years of Technology Leadership to Illumina 122

6.66 Feb 07, 2017: Sphere Medical showcasing next generation Proxima bedside blood gas analyser at German critical care congresses 123

6.67 Feb 06, 2017: Luminex Reports Fourth Quarter And Full Year 2016 Results 123

6.68 Feb 02, 2017: PerkinElmer Announces Financial Results for Fourth Quarter and Full Year 2016 124

6.69 Feb 02, 2017: BD Announces Results For 2017 First Fiscal Quarter 126

6.70 Feb 01, 2017: Jim Hagemann Snabe proposed as new Chairman of Siemens' Supervisory Board 127

6.71 Feb 01, 2017: QIAGEN Reports Results for Fourth Quarter and Full-year 2016 128

6.72 Jan 31, 2017: Curetis' Global Installed Base Expanding to Over 150 Unyvero Analyzers 132

6.73 Jan 31, 2017: Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2016 Results 133

6.74 Jan 31, 2017: Siemens: First Quarter Results FY 2017 135

6.75 Jan 31, 2017: Illumina Reports Full Financial Results for Fourth Quarter and Fiscal Year 2016 135

6.76 Jan 27, 2017: Illumina Names Caroline Dorsa to Its Board of Directors, Adding Over 30 Years of Leadership Experience in the Healthcare, Telecommunications and Energy Industries 137

6.77 Jan 26, 2017: Abaxis Reports Financial Performance for the Third Quarter of Fiscal 2017, Declares Quarterly Cash Dividend 138

6.78 Jan 23, 2017: ISO 17025 Accreditation for Microbiology Manufacturing Site Offers Increased Confidence to Microbiology Testing Laboratories 139

6.79 Jan 19, 2017: bioMerieux-Fourth-Quarter 2016 Business Review 140

6.80 Jan 13, 2017: Eppendorf: William Linton is new member of the Supervisory Board 142

6.81 Jan 10, 2017: Abaxis Reports Preliminary Financial Performance For The Third Quarter Of Fiscal 2017 142

6.82 Jan 10, 2017: New CEO and Group President at Boule Diagnostics 143

6.83 Jan 09, 2017: Luminex Announces Preliminary Revenue for Fourth Quarter 2016 and Issues 2017 Revenue Guidance 143

6.84 Jan 06, 2017: Theranos Announces Company Re-engineers Operations 144

6.85 Jan 04, 2017: Roche launches cobas c 513 analyzer and HbA1c Gen. 3 assay to meet increasing demand for testing of people with diabetes 144

6.86 Jan 04, 2017: Alere Laboratory Receives ABFT Accreditation 145

6.87 Jan 04, 2017: Alere Provides Update on Arriva Medical 145

6.88 Jan 03, 2017: Illumina Taps Garret Hampton, One of the Worlds Leading Clinical Genomics Experts, to Head its Clinical Genomics Unit 145

6.89 Dec 28, 2016: Alere Provides Update on Arriva Medical 146

6.90 Dec 20, 2016: Illumina Names Jonathan Seaton as Senior Vice President for Corporate & Business Development, Adding Further Clinical and Life Sciences Expertise to its Executive Team 147

6.91 Dec 19, 2016: Instrumentation Laboratory Receives US FDA Clearance For New GEM Premier 5000 Critical Care Testing System 147

6.92 Dec 19, 2016: OPKO Health to be Added to the NASDAQ Biotechnology Index 148

6.93 Dec 14, 2016: Beckman Coulter appoints IT Product Manager for Northern Europe 148

6.94 Dec 08, 2016: Khang & Khang Announces Securities Class Action Lawsuit against Alere and Reminds Investors with Losses to Contact the Firm 149

6.95 Dec 07, 2016: Illumina appoints senior vice president and CFO 149

6.96 Dec 07, 2016: Abbott Seeks To Terminate Alere Acquisition 150

6.97 Dec 07, 2016: Illumina Extends Management Team, Appoints Sam A. Samad as Senior Vice President and Chief Financial Officer 150

6.98 Nov 29, 2016: ERBA Diagnostics names interim CEO 150

6.99 Nov 21, 2016: Agenix: Retirement of Director 151

6.100 Nov 21, 2016: Agenix: Change of Registered Office 151

6.101 Nov 18, 2016: Curetis Publishes Business and Financial Update for the First Nine Months 2016 152

6.102 Nov 18, 2016: Renishaw appoints a new distributor in the Nordic region 153

6.103 Nov 14, 2016: Akers Biosciences Announces Q3 Earnings 154

6.104 Nov 10, 2016: Diasorin Group Reports Continued Growth In Revenues And Profitability In The Third Quarter 2016 155

6.105 Nov 09, 2016: Boule Diagnostics interim report January-September 2016 156

6.106 Nov 08, 2016: Exact Sciences Appoints Jeff Elliott Chief Financial Officer 157

6.107 Nov 07, 2016: OPKO Health Reports Third Quarter Financial and Operating Results 158

6.108 Nov 07, 2016: PerkinElmer Announces Financial Results for the Third Quarter of 2016 159

6.109 Nov 07, 2016: Pierre Boulud appointed Corporate Vice Presidentof the Asia Pacific region at bioMerieux 160

6.110 Nov 04, 2016: Alere Reports Third Quarter 2016 Financial Results 161

6.111 Nov 03, 2016: BD Announces Results For 2016 Fourth Fiscal Quarter And Full Year; Provides Fiscal 2017 Guidance 161

6.112 Nov 02, 2016: QIAGEN Reports Results for Third Quarter and First Nine Months of 2016 163

6.113 Nov 02, 2016: Lak Ananth to head new next47 startup unit 166

6.114 Nov 02, 2016: QIAGEN launches restructuring initiatives, revises outlook for 2016 earnings and provides initial net sales and adjusted earnings guidance for 2017 167

6.115 Nov 01, 2016: Bio-Rad Reports Third-Quarter Currency-Neutral Revenue Growth of 9.1 Percent 167

6.116 Nov 01, 2016: Illumina Reports Full Financial Results for Third Quarter of Fiscal Year 2016 168

6.117 Nov 01, 2016: Asuragen Launches QuantideX NGS RNA Lung Cancer Kit 169

6.118 Nov 01, 2016: Introducing Renishaw's new RA802 Pharmaceutical Analyser 170

6.119 Oct 31, 2016: Luminex Reports Third Quarter 2016 Results; Raises Full Year Guidance 171

6.120 Oct 31, 2016: Changes in the Management Board of Eppendorf 171

6.121 Oct 27, 2016: Thermo Fisher Scientific Reports Third Quarter 2016 Results 171

6.122 Oct 25, 2016: Abaxis Reports Financial Performance For The Second Quarter Of Fiscal 2017 173

6.123 Oct 20, 2016: bioMerieux-Business Review for the nine months ended September 30, 2016 175

6.124 Oct 20, 2016: QIAGEN launches QIAscout for single-cell isolation 178

6.125 Oct 20, 2016: Kyowa Medex to exhibit at MEDICA 2016, Messe Dusseldorf, Germany, Nov 14-17 2016 179

6.126 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results 179

6.127 Oct 18, 2016: Agenix: US sales and key appointment 182

6.128 Oct 17, 2016: PerkinElmer Elects Samuel Chapin to Board of Directors 182

6.129 Oct 17, 2016: Thermo Fisher Scientific Enables Preemptive Pharmacogenomic Screening Research with New PharmacoScan Solution 182

6.130 Oct 17, 2016: New design of hematology and clinical chemistry analyzers 183

6.131 Oct 14, 2016: Agenix: Appointment of Independent Non-Executive Directors 184

6.132 Oct 10, 2016: Illumina Announces Preliminary Revenue for Third Quarter of Fiscal Year 2016 184

6.133 Sep 26, 2016: PerkinElmer Announces New Organizational Structure 184

6.134 Sep 24, 2016: Proxima Demonstrated at NVIC Congress Following Significant Sale in Benelux 185

6.135 Sep 23, 2016: Siegfried Russwurm to resign by mutual agreement from the Siemens Management Board 185

6.136 Sep 15, 2016: Unique in-line blood gas analyser selected to feature in BACCN annual conference Simulation Lab 186

6.137 Sep 13, 2016: OPKO Health Appoints Jane Pine Wood as Chief Legal and Compliance Officer of BioReference Laboratories 186

6.138 Sep 12, 2016: Patient-dedicated blood gas analysis enhances flu readiness and infection control 187

6.139 Sep 12, 2016: EKF Diagnostics Holdings: Half-year Report 187

6.140 Sep 06, 2016: Alere Reports Second Quarter 2016 Financial Results 190

6.141 Aug 31, 2016: bioMerieux-First-Half 2016 Results 191

6.142 Aug 30, 2016: Sphere Medical expands sales into Belgium 195

6.143 Aug 30, 2016: AGENIX Announces Annual Result For The Year Ended 30 June 2016 195

6.144 Aug 19, 2016: Curetis Reports Financial Results for the First Six Months of 2016 196

6.145 Aug 17, 2016: Alere Reports First Quarter 2016 Financial Results 198

6.146 Aug 11, 2016: Akers Biosciences Announces H1 and Q2 2016 Earnings 199

6.147 Aug 08, 2016: OPKO Health Reports Improved Financial and Operating Results 201

6.148 Aug 08, 2016: Alere Files Form 10-K, Reports Fourth Quarter and Full Year 2015 Financial Results 202

6.149 Aug 04, 2016: BD Announces Results For 2016 Third Fiscal Quarter 204

6.150 Aug 04, 2016: PerkinElmer Announces Financial Results for the Second Quarter of 2016 206

6.151 Aug 04, 2016: Diasorin Group Revenues And EBITDA Reached Record highs In the Second Quarter 2016 207

6.152 Aug 03, 2016: Bio-Rad Reports Second-Quarter 2016 Financial Results 211

6.153 Aug 03, 2016: Kyowa Medex Announced Insurance Coverage of 25-Hydroxyvitamin D Assay 211

7 Appendix 212

7.1 Methodology 212

7.2 About GlobalData 215

7.3 Contact Us 215

7.4 Disclaimer 215


List Of Figure

1.2 List of Figures

Figure 1: Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 10

Figure 2: Clinical Chemistry Analyzers-Pipeline Products by Segment 11

Figure 3: Clinical Chemistry Analyzers-Pipeline Products by Territory 12

Figure 4: Clinical Chemistry Analyzers-Pipeline Products by Regulatory Path 13

Figure 5: Clinical Chemistry Analyzers-Pipeline Products by Estimated Approval Date 14

Figure 6: Clinical Chemistry Analyzers-Ongoing Clinical Trials 15


List Of Table

1.1 List of Tables

Table 1: Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 10

Table 2: Clinical Chemistry Analyzers-Pipeline Products by Segment 11

Table 3: Clinical Chemistry Analyzers-Pipeline Products by Territory 12

Table 4: Clinical Chemistry Analyzers-Pipeline Products by Regulatory Path 13

Table 5: Clinical Chemistry Analyzers-Pipeline Products by Estimated Approval Date 14

Table 6: Clinical Chemistry Analyzers-Ongoing Clinical Trials 15

Table 7: Clinical Chemistry Analyzers Companies-Pipeline Products by Stage of Development 16

Table 8: Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 18

Table 9: All Medicus Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 19

Table 10: Biosensor System-AST/ALT-Product Status 19

Table 11: Biosensor System-AST/ALT-Product Description 19

Table 12: Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 20

Table 13: Biolyzer 100-Product Status 20

Table 14: Biolyzer 100-Product Description 20

Table 15: Biolyzer 300-Product Status 21

Table 16: Biolyzer 300-Product Description 21

Table 17: Biolyzer 600-Product Status 21

Table 18: Biolyzer 600-Product Description 22

Table 19: Ativa Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 23

Table 20: Ativa Micro-Lab System-Product Status 23

Table 21: Ativa Micro-Lab System-Product Description 23

Table 22: Aviv Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

Table 23: Bili-4 Hematofluorometer-Product Status 24

Table 24: Bili-4 Hematofluorometer-Product Description 24

Table 25: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Table 26: DxC 700 AU-Product Status 25

Table 27: DxC 700 AU-Product Description 25

Table 28: Curetis NV Pipeline Products & Ongoing Clinical Trials Overview 26

Table 29: Unyvero Analyzer-Product Status 26

Table 30: Unyvero Analyzer-Product Description 27

Table 31: Daxor Corp Pipeline Products & Ongoing Clinical Trials Overview 28

Table 32: Total Blood Volume Analyzer-Total Body Albumin-Product Status 28

Table 33: Total Blood Volume Analyzer-Total Body Albumin-Product Description 28

Table 34: DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 29

Table 35: QDx Lipidcheck-Product Status 29

Table 36: QDx Lipidcheck-Product Description 29

Table 37: respons940-Product Status 30

Table 38: respons940-Product Description 30

Table 39: Emergent Detection Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

Table 40: BodyKey Fat Loss Sensor-Product Status 31

Table 41: BodyKey Fat Loss Sensor-Product Description 31

Table 42: Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 32

Table 43: Paper-Based Microfluidic Analytical System-Product Status 32

Table 44: Paper-Based Microfluidic Analytical System-Product Description 32

Table 45: Illumina, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

Table 46: LSD-100 Lysosomal Storage Enzyme Analyzer-Product Status 33

Table 47: LSD-100 Lysosomal Storage Enzyme Analyzer-Product Description 34

Table 48: Instrumentation Laboratory Company Pipeline Products & Ongoing Clinical Trials Overview 35

Table 49: GEM Premier 5000-Glucose/Lactate/Total Bilirubin-Product Status 35

Table 50: GEM Premier 5000-Glucose/Lactate/Total Bilirubin-Product Description 35

Table 51: GEM Premier 5000-Hemoglobin And Oxygen Saturation-Product Status 36

Table 52: GEM Premier 5000-Hemoglobin And Oxygen Saturation-Product Description 36

Table 53: GEM Premier 5000-pH/pCO2/pO2-Product Status 36

Table 54: GEM Premier 5000-pH/pCO2/pO2-Product Description 37

Table 55: GEM Premier 5000 System-Product Status 37

Table 56: GEM Premier 5000 System-Product Description 37

Table 57: Invivomon Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 38

Table 58: Miniature Analyzer-Product Status 38

Table 59: Miniature Analyzer-Product Description 38

Table 60: I-Sens Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 61: Blood Gas Analyzer-Product Status 39

Table 62: Blood Gas Analyzer-Product Description 39

Table 63: MyCartis NV Pipeline Products & Ongoing Clinical Trials Overview 40

Table 64: Evalution-Product Status 40

Table 65: Evalution-Product Description 40

Table 66: NanoIVD Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 67: NanoIVD Clinical Analyzer-I-Product Status 41

Table 68: NanoIVD Clinical Analyzer-I-Product Description 41

Table 69: National Institute of Biomedical Imaging and Bioengineering Pipeline Products & Ongoing Clinical Trials Overview 42

Table 70: Microfluidic Diagnostic Card-Product Status 42

Table 71: Microfluidic Diagnostic Card-Product Description 42

Table 72: NeuMoDx Molecular, Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 73: NeuMoDx 500 Molecular IVD System-Product Status 43

Table 74: NeuMoDx 500 Molecular IVD System-Product Description 43

Table 75: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 76: Claros 1 Analyzer-Product Status 44

Table 77: Claros 1 Analyzer-Product Description 44

Table 78: OPKO Health Inc-Ongoing Clinical Trials Overview 45

Table 79: Claros 1 Analyzer-Claros 1 Clinical Trial for Total PSA 46

Table 80: Samsung Electronics Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 47

Table 81: LABGEO PT10-Product Status 47

Table 82: LABGEO PT10-Product Description 48

Table 83: Smiths Detection Group Limited Pipeline Products & Ongoing Clinical Trials Overview 49

Table 84: Bio-Seeq-Clinical-Product Status 49

Table 85: Bio-Seeq-Clinical-Product Description 49

Table 86: The Hong Kong University of Science and Technology Pipeline Products & Ongoing Clinical Trials Overview 50

Table 87: Portable Real-time PCR System-Product Status 50

Table 88: Portable Real-time PCR System-Product Description 50

Table 89: Theranos Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Table 90: miniLab System-Product Status 51

Table 91: miniLab System-Product Description 51

Table 92: Thermal Gradient Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Table 93: Flash HT-Product Status 52

Table 94: Flash HT-Product Description 52

Table 95: Glossary 214

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Products and Companies

Products

All Medicus Co Ltd, Biosensor System-AST/ALT; Analyticon Biotechnologies AG, Biolyzer 100; Analyticon Biotechnologies AG, Biolyzer 300; Analyticon Biotechnologies AG, Biolyzer 600; Ativa Medical Inc, Ativa Micro-Lab System; Aviv Biomedical, Inc., Bili-4 Hematofluorometer; Beckman Coulter Inc, DxC 700 AU; Curetis NV, Unyvero Analyzer; Daxor Corp, Total Blood Volume Analyzer-Total Body Albumin; DiaSys Diagnostic Systems GmbH, QDx Lipidcheck; DiaSys Diagnostic Systems GmbH, respons940; Emergent Detection Inc (Inactive), BodyKey Fat Loss Sensor; Hansjorg Wyss Institute for Biologically Inspired Engineering, Paper-Based Microfluidic Analytical System; Illumina, Inc., LSD-100 Lysosomal Storage Enzyme Analyzer; Instrumentation Laboratory Company, GEM Premier 5000-Glucose/Lactate/Total Bilirubin; Instrumentation Laboratory Company, GEM Premier 5000-Hemoglobin And Oxygen Saturation; Instrumentation Laboratory Company, GEM Premier 5000-pH/pCO2/pO2; Instrumentation Laboratory Company, GEM Premier 5000 System; Invivomon Inc (Inactive), Miniature Analyzer; I-Sens Inc, Blood Gas Analyzer; MyCartis NV, Evalution; NanoIVD Inc, NanoIVD Clinical Analyzer-I; National Institute of Biomedical Imaging and Bioengineering, Microfluidic Diagnostic Card; NeuMoDx Molecular, Inc, NeuMoDx 500 Molecular IVD System; OPKO Health Inc, Claros 1 Analyzer; Samsung Electronics Co., Ltd., LABGEO PT10; Smiths Detection Group Limited, Bio-Seeq-Clinical; The Hong Kong University of Science and Technology, Portable Real-time PCR System; Theranos Inc, miniLab System; Thermal Gradient Inc, Flash HT


Companies

All Medicus Co Ltd

Analyticon Biotechnologies AG

Ativa Medical Inc

Aviv Biomedical, Inc.

Beckman Coulter Inc

Curetis NV

Daxor Corp

DiaSys Diagnostic Systems GmbH

Emergent Detection Inc

Hansjorg Wyss Institute for Biologically Inspired Engineering

Illumina, Inc.

Instrumentation Laboratory Company

Invivomon Inc

I-Sens Inc

MyCartis NV

NanoIVD Inc

National Institute of Biomedical Imaging and Bioengineering

NeuMoDx Molecular, Inc

OPKO Health Inc

Samsung Electronics Co., Ltd.

Smiths Detection Group Limited

The Hong Kong University of Science and Technology

Theranos Inc

Thermal Gradient Inc

Company Profile

Company Profile Title

Clinical Chemistry Analyzers-Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, "Clinical Chemistry Analyzers-Medical Devices Pipeline Assessment, 2017" provides an overview of Clinical Chemistry Analyzers 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 Analyzers 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 Analyzers 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 Analyzers 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 Analyzers 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

READ MORE

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 9

2.1 Clinical Chemistry Analyzers Overview 9

3 Products under Development 10

3.1 Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 10

3.2 Clinical Chemistry Analyzers-Pipeline Products by Segment 11

3.3 Clinical Chemistry Analyzers-Pipeline Products by Territory 12

3.4 Clinical Chemistry Analyzers-Pipeline Products by Regulatory Path 13

3.5 Clinical Chemistry Analyzers-Pipeline Products by Estimated Approval Date 14

3.6 Clinical Chemistry Analyzers-Ongoing Clinical Trials 15

4 Clinical Chemistry Analyzers-Pipeline Products under Development by Companies 16

4.1 Clinical Chemistry Analyzers Companies-Pipeline Products by Stage of Development 16

4.2 Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 18

5 Clinical Chemistry Analyzers Companies and Product Overview 19

5.1 All Medicus Co Ltd Company Overview 19

5.1.1 All Medicus Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 19

5.2 Analyticon Biotechnologies AG Company Overview 20

5.2.1 Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 20

5.3 Ativa Medical Inc Company Overview 23

5.3.1 Ativa Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.4 Aviv Biomedical, Inc. Company Overview 24

5.4.1 Aviv Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

5.5 Beckman Coulter Inc Company Overview 25

5.5.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.6 Curetis NV Company Overview 26

5.6.1 Curetis NV Pipeline Products & Ongoing Clinical Trials Overview 26

5.7 Daxor Corp Company Overview 28

5.7.1 Daxor Corp Pipeline Products & Ongoing Clinical Trials Overview 28

5.8 DiaSys Diagnostic Systems GmbH Company Overview 29

5.8.1 DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 29

5.9 Emergent Detection Inc (Inactive) Company Overview 31

5.9.1 Emergent Detection Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

5.10 Hansjorg Wyss Institute for Biologically Inspired Engineering Company Overview 32

5.10.1 Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 32

5.11 Illumina, Inc. Company Overview 33

5.11.1 Illumina, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.12 Instrumentation Laboratory Company Company Overview 35

5.12.1 Instrumentation Laboratory Company Pipeline Products & Ongoing Clinical Trials Overview 35

5.13 Invivomon Inc (Inactive) Company Overview 38

5.13.1 Invivomon Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 38

5.14 I-Sens Inc Company Overview 39

5.14.1 I-Sens Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.15 MyCartis NV Company Overview 40

5.15.1 MyCartis NV Pipeline Products & Ongoing Clinical Trials Overview 40

5.16 NanoIVD Inc Company Overview 41

5.16.1 NanoIVD Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.17 National Institute of Biomedical Imaging and Bioengineering Company Overview 42

5.17.1 National Institute of Biomedical Imaging and Bioengineering Pipeline Products & Ongoing Clinical Trials Overview 42

5.18 NeuMoDx Molecular, Inc Company Overview 43

5.18.1 NeuMoDx Molecular, Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.19 OPKO Health Inc Company Overview 44

5.19.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.20 Samsung Electronics Co., Ltd. Company Overview 47

5.20.1 Samsung Electronics Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 47

5.21 Smiths Detection Group Limited Company Overview 49

5.21.1 Smiths Detection Group Limited Pipeline Products & Ongoing Clinical Trials Overview 49

5.22 The Hong Kong University of Science and Technology Company Overview 50

5.22.1 The Hong Kong University of Science and Technology Pipeline Products & Ongoing Clinical Trials Overview 50

5.23 Theranos Inc Company Overview 51

5.23.1 Theranos Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.24 Thermal Gradient Inc Company Overview 52

5.24.1 Thermal Gradient Inc Pipeline Products & Ongoing Clinical Trials Overview 52

6 Clinical Chemistry Analyzers-Recent Developments 53

6.1 Jul 26, 2017: Thermo Fisher Scientific Reports Second Quarter 2017 Results 53

6.2 Jul 25, 2017: Cologuard revenue increased to $57.6 million during second quarter; Test volume grew 149 percent from second quarter of 2016 to 135,000 completed tests 54

6.3 Jul 25, 2017: ERBA Diagnostics Appoints David Barka as Interim Chief Executive Officer, Nikhil Vazirani as Member of the Board 55

6.4 Jul 20, 2017: bioMerieux-Second-Quarter 2017 Business Review 56

6.5 Jul 20, 2017: Abbott Reports Second-Quarter 2017 Results 58

6.6 Jul 11, 2017: Promega First to Achieve Third-Party Certification of Published ISO 18385 Manufacturing Standard to Minimize Risk of Human DNA Contamination in Forensic Products 60

6.7 Jul 06, 2017: Kurt H. Kruger joins Qualigen's Board of Directors 61

6.8 Jul 06, 2017: Richard David, MD, FACS joins Qualigen's Board of Directors 61

6.9 Jul 03, 2017: Premaitha Health Litigation Update 62

6.10 Jun 29, 2017: Sphere Medical confirms compatibility of Proxima bedside blood gas monitoring system with leading global monitoring company 62

6.11 Jun 29, 2017: MSP bodmann appointed as new distributor in Germany 63

6.12 Jun 14, 2017: Alere Reports First Quarter 2017 Financial Results 63

6.13 Jun 13, 2017: FlowJo and BD to Provide Cloud Platform for Real-Time Single-Cell Marketing Collaboration 64

6.14 Jun 12, 2017: New Immobilized Lux Chiral LC-SFC Selector from Phenomenex Delivers Broad Enantioselectivity 65

6.15 Jun 06, 2017: BD Releases 2016 Sustainability Report 65

6.16 Jun 05, 2017: Alere Files Form 10-K, Reports Fourth Quarter and Full Year 2016 Financial Results 66

6.17 May 31, 2017: Daxor Announces Hiring of Chief Financial Officer 66

6.18 May 24, 2017: Curetis Provides Business and Financial Update for the First Quarter 2017 67

6.19 May 22, 2017: Illumina Names Mark Van Oene Chief Commercial Officer, Sales Leader Brings Genomics Expertise and Strong Commercial Leadership Experience to the Role 69

6.20 May 22, 2017: Alere Provides Preliminary Unaudited Financial Results 69

6.21 May 16, 2017: Boule Diagnostics optimizes the manufacturing structure-shuts down the Chinese production facility 70

6.22 May 16, 2017: Akers Biosciences Announces Q1 2017 Earnings 70

6.23 May 11, 2017: Boule Diagnostics: interim report January-March 2017 72

6.24 May 09, 2017: OPKO Health Reports 2016 Financial and Operating Results 73

6.25 May 04, 2017: Siemens: Earnings Release and Financial Results Q2 FY 2017: Another strong quarter-profitable growth continuing 74

6.26 May 04, 2017: PerkinElmer Announces Financial Results for the First Quarter of 2017 76

6.27 May 04, 2017: Bio-Rad Reports First-Quarter 2017 Financial Results 77

6.28 May 02, 2017: BD Announces Results For 2017 Second Fiscal Quarter 78

6.29 May 02, 2017: QIAGEN reports results for first quarter 2017 80

6.30 May 01, 2017: Luminex Reports Record First Quarter 2017 Financial Results; Raises 2017 Financial Guidance 83

6.31 Apr 28, 2017: IDEXX Laboratories Announces First Quarter Results-2017 83

6.32 Apr 27, 2017: Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2017 and Declares Quarterly Cash Dividend 86

6.33 Apr 26, 2017: Thermo Fisher Scientific Reports First Quarter 2017 Results 87

6.34 Apr 25, 2017: Illumina Reports Financial Results for First Quarter of Fiscal Year 2017 88

6.35 Apr 23, 2017: BD Announces Appointment Of Tom Polen As President 90

6.36 Apr 20, 2017: bioMerieux-First-Quarter 2017 Business Review 90

6.37 Apr 19, 2017: Abbott Reports First-Quarter 2017 Results 93

6.38 Apr 17, 2017: Toshiba Medical Names Dan Skyba Director of Ultrasound Business Unit 95

6.39 Apr 12, 2017: Curetis Reports Full-Year 2016 Financial Results and Updates 2017 Guidance 96

6.40 Apr 12, 2017: Curetis Expands Supervisory and Medical Advisory Boards 97

6.41 Apr 11, 2017: Akers Bioscience: Financial Results for the Year Ended December 31, 2016 98

6.42 Apr 11, 2017: Akers Biosciences Reports Earnings for Fiscal Year 2016 99

6.43 Apr 06, 2017: Curetis Starts Subsidiary Ares Genetics to Advance Genetic Antibiotic Resistance Testing 103

6.44 Apr 03, 2017: Supervisory Board of Siemens Healthineers ensures management continuity 105

6.45 Apr 01, 2017: New Release of H30 Fully Automated Hematology Analyzer 105

6.46 Mar 31, 2017: HORIBA Instruments commences operations at new factory in Houston 105

6.47 Mar 30, 2017: Akers Biosciences Reports Preliminary Unaudited Earnings Highlights for Fiscal Year 2016 106

6.48 Mar 28, 2017: BD Announces Success of Helping Build Healthy Communities Program, Launches New Effort Focused on Medication Therapy Management 108

6.49 Mar 27, 2017: Boule Diagnostics increases focus on Indonesia-Receives grant from Swedfund 108

6.50 Mar 23, 2017: PerkinElmer to Display Portfolio of Cancer Research Technologies and Workflow Solutions at 2017 AACR Annual Meeting 109

6.51 Mar 21, 2017: Retractable Technologies Announces Litigation Updates 110

6.52 Mar 20, 2017: EKF Diagnostics Holdings: Final results 111

6.53 Mar 17, 2017: Eva Schulz-Kamm appointed global head of Government Affairs at Siemens 111

6.54 Mar 14, 2017: Hospital ICU study demonstrates significant reduction in time to blood gas result using Sphere Medicals Proxima 111

6.55 Mar 13, 2017: Bio-Rad Intends to Propose Three New Independent Directors 112

6.56 Mar 13, 2017: Bio-Rad Initiates Long Term Financial Guidance; Commits to Defining Long Term Capital Allocation Targets and Hosting an Annual Investor Day 113

6.57 Mar 09, 2017: Alere Provides Update on Arriva Medical 114

6.58 Mar 07, 2017: Beckman Coulter Diagnostics Receives FDA Clearance for its DxC 700 AU Chemistry Analyzer 115

6.59 Mar 03, 2017: OPKO Health Appoints Dr. Akhtar Ashfaq as Renal Division Senior Vice President, Clinical Research and Development 115

6.60 Mar 01, 2017: OPKO Health Reports 2016 Financial and Operating Results 116

6.61 Mar 01, 2017: Thermo Fisher Scientific Elects New Director to Board 117

6.62 Feb 23, 2017: VBio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 118

6.63 Feb 23, 2017: Bio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 120

6.64 Feb 23, 2017: Renishaw exhibiting at BioWales 2017 122

6.65 Feb 20, 2017: Illumina Names John W. Thompson to Its Board of Directors, Bringing More Than 40 Years of Technology Leadership to Illumina 122

6.66 Feb 07, 2017: Sphere Medical showcasing next generation Proxima bedside blood gas analyser at German critical care congresses 123

6.67 Feb 06, 2017: Luminex Reports Fourth Quarter And Full Year 2016 Results 123

6.68 Feb 02, 2017: PerkinElmer Announces Financial Results for Fourth Quarter and Full Year 2016 124

6.69 Feb 02, 2017: BD Announces Results For 2017 First Fiscal Quarter 126

6.70 Feb 01, 2017: Jim Hagemann Snabe proposed as new Chairman of Siemens' Supervisory Board 127

6.71 Feb 01, 2017: QIAGEN Reports Results for Fourth Quarter and Full-year 2016 128

6.72 Jan 31, 2017: Curetis' Global Installed Base Expanding to Over 150 Unyvero Analyzers 132

6.73 Jan 31, 2017: Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2016 Results 133

6.74 Jan 31, 2017: Siemens: First Quarter Results FY 2017 135

6.75 Jan 31, 2017: Illumina Reports Full Financial Results for Fourth Quarter and Fiscal Year 2016 135

6.76 Jan 27, 2017: Illumina Names Caroline Dorsa to Its Board of Directors, Adding Over 30 Years of Leadership Experience in the Healthcare, Telecommunications and Energy Industries 137

6.77 Jan 26, 2017: Abaxis Reports Financial Performance for the Third Quarter of Fiscal 2017, Declares Quarterly Cash Dividend 138

6.78 Jan 23, 2017: ISO 17025 Accreditation for Microbiology Manufacturing Site Offers Increased Confidence to Microbiology Testing Laboratories 139

6.79 Jan 19, 2017: bioMerieux-Fourth-Quarter 2016 Business Review 140

6.80 Jan 13, 2017: Eppendorf: William Linton is new member of the Supervisory Board 142

6.81 Jan 10, 2017: Abaxis Reports Preliminary Financial Performance For The Third Quarter Of Fiscal 2017 142

6.82 Jan 10, 2017: New CEO and Group President at Boule Diagnostics 143

6.83 Jan 09, 2017: Luminex Announces Preliminary Revenue for Fourth Quarter 2016 and Issues 2017 Revenue Guidance 143

6.84 Jan 06, 2017: Theranos Announces Company Re-engineers Operations 144

6.85 Jan 04, 2017: Roche launches cobas c 513 analyzer and HbA1c Gen. 3 assay to meet increasing demand for testing of people with diabetes 144

6.86 Jan 04, 2017: Alere Laboratory Receives ABFT Accreditation 145

6.87 Jan 04, 2017: Alere Provides Update on Arriva Medical 145

6.88 Jan 03, 2017: Illumina Taps Garret Hampton, One of the Worlds Leading Clinical Genomics Experts, to Head its Clinical Genomics Unit 145

6.89 Dec 28, 2016: Alere Provides Update on Arriva Medical 146

6.90 Dec 20, 2016: Illumina Names Jonathan Seaton as Senior Vice President for Corporate & Business Development, Adding Further Clinical and Life Sciences Expertise to its Executive Team 147

6.91 Dec 19, 2016: Instrumentation Laboratory Receives US FDA Clearance For New GEM Premier 5000 Critical Care Testing System 147

6.92 Dec 19, 2016: OPKO Health to be Added to the NASDAQ Biotechnology Index 148

6.93 Dec 14, 2016: Beckman Coulter appoints IT Product Manager for Northern Europe 148

6.94 Dec 08, 2016: Khang & Khang Announces Securities Class Action Lawsuit against Alere and Reminds Investors with Losses to Contact the Firm 149

6.95 Dec 07, 2016: Illumina appoints senior vice president and CFO 149

6.96 Dec 07, 2016: Abbott Seeks To Terminate Alere Acquisition 150

6.97 Dec 07, 2016: Illumina Extends Management Team, Appoints Sam A. Samad as Senior Vice President and Chief Financial Officer 150

6.98 Nov 29, 2016: ERBA Diagnostics names interim CEO 150

6.99 Nov 21, 2016: Agenix: Retirement of Director 151

6.100 Nov 21, 2016: Agenix: Change of Registered Office 151

6.101 Nov 18, 2016: Curetis Publishes Business and Financial Update for the First Nine Months 2016 152

6.102 Nov 18, 2016: Renishaw appoints a new distributor in the Nordic region 153

6.103 Nov 14, 2016: Akers Biosciences Announces Q3 Earnings 154

6.104 Nov 10, 2016: Diasorin Group Reports Continued Growth In Revenues And Profitability In The Third Quarter 2016 155

6.105 Nov 09, 2016: Boule Diagnostics interim report January-September 2016 156

6.106 Nov 08, 2016: Exact Sciences Appoints Jeff Elliott Chief Financial Officer 157

6.107 Nov 07, 2016: OPKO Health Reports Third Quarter Financial and Operating Results 158

6.108 Nov 07, 2016: PerkinElmer Announces Financial Results for the Third Quarter of 2016 159

6.109 Nov 07, 2016: Pierre Boulud appointed Corporate Vice Presidentof the Asia Pacific region at bioMerieux 160

6.110 Nov 04, 2016: Alere Reports Third Quarter 2016 Financial Results 161

6.111 Nov 03, 2016: BD Announces Results For 2016 Fourth Fiscal Quarter And Full Year; Provides Fiscal 2017 Guidance 161

6.112 Nov 02, 2016: QIAGEN Reports Results for Third Quarter and First Nine Months of 2016 163

6.113 Nov 02, 2016: Lak Ananth to head new next47 startup unit 166

6.114 Nov 02, 2016: QIAGEN launches restructuring initiatives, revises outlook for 2016 earnings and provides initial net sales and adjusted earnings guidance for 2017 167

6.115 Nov 01, 2016: Bio-Rad Reports Third-Quarter Currency-Neutral Revenue Growth of 9.1 Percent 167

6.116 Nov 01, 2016: Illumina Reports Full Financial Results for Third Quarter of Fiscal Year 2016 168

6.117 Nov 01, 2016: Asuragen Launches QuantideX NGS RNA Lung Cancer Kit 169

6.118 Nov 01, 2016: Introducing Renishaw's new RA802 Pharmaceutical Analyser 170

6.119 Oct 31, 2016: Luminex Reports Third Quarter 2016 Results; Raises Full Year Guidance 171

6.120 Oct 31, 2016: Changes in the Management Board of Eppendorf 171

6.121 Oct 27, 2016: Thermo Fisher Scientific Reports Third Quarter 2016 Results 171

6.122 Oct 25, 2016: Abaxis Reports Financial Performance For The Second Quarter Of Fiscal 2017 173

6.123 Oct 20, 2016: bioMerieux-Business Review for the nine months ended September 30, 2016 175

6.124 Oct 20, 2016: QIAGEN launches QIAscout for single-cell isolation 178

6.125 Oct 20, 2016: Kyowa Medex to exhibit at MEDICA 2016, Messe Dusseldorf, Germany, Nov 14-17 2016 179

6.126 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results 179

6.127 Oct 18, 2016: Agenix: US sales and key appointment 182

6.128 Oct 17, 2016: PerkinElmer Elects Samuel Chapin to Board of Directors 182

6.129 Oct 17, 2016: Thermo Fisher Scientific Enables Preemptive Pharmacogenomic Screening Research with New PharmacoScan Solution 182

6.130 Oct 17, 2016: New design of hematology and clinical chemistry analyzers 183

6.131 Oct 14, 2016: Agenix: Appointment of Independent Non-Executive Directors 184

6.132 Oct 10, 2016: Illumina Announces Preliminary Revenue for Third Quarter of Fiscal Year 2016 184

6.133 Sep 26, 2016: PerkinElmer Announces New Organizational Structure 184

6.134 Sep 24, 2016: Proxima Demonstrated at NVIC Congress Following Significant Sale in Benelux 185

6.135 Sep 23, 2016: Siegfried Russwurm to resign by mutual agreement from the Siemens Management Board 185

6.136 Sep 15, 2016: Unique in-line blood gas analyser selected to feature in BACCN annual conference Simulation Lab 186

6.137 Sep 13, 2016: OPKO Health Appoints Jane Pine Wood as Chief Legal and Compliance Officer of BioReference Laboratories 186

6.138 Sep 12, 2016: Patient-dedicated blood gas analysis enhances flu readiness and infection control 187

6.139 Sep 12, 2016: EKF Diagnostics Holdings: Half-year Report 187

6.140 Sep 06, 2016: Alere Reports Second Quarter 2016 Financial Results 190

6.141 Aug 31, 2016: bioMerieux-First-Half 2016 Results 191

6.142 Aug 30, 2016: Sphere Medical expands sales into Belgium 195

6.143 Aug 30, 2016: AGENIX Announces Annual Result For The Year Ended 30 June 2016 195

6.144 Aug 19, 2016: Curetis Reports Financial Results for the First Six Months of 2016 196

6.145 Aug 17, 2016: Alere Reports First Quarter 2016 Financial Results 198

6.146 Aug 11, 2016: Akers Biosciences Announces H1 and Q2 2016 Earnings 199

6.147 Aug 08, 2016: OPKO Health Reports Improved Financial and Operating Results 201

6.148 Aug 08, 2016: Alere Files Form 10-K, Reports Fourth Quarter and Full Year 2015 Financial Results 202

6.149 Aug 04, 2016: BD Announces Results For 2016 Third Fiscal Quarter 204

6.150 Aug 04, 2016: PerkinElmer Announces Financial Results for the Second Quarter of 2016 206

6.151 Aug 04, 2016: Diasorin Group Revenues And EBITDA Reached Record highs In the Second Quarter 2016 207

6.152 Aug 03, 2016: Bio-Rad Reports Second-Quarter 2016 Financial Results 211

6.153 Aug 03, 2016: Kyowa Medex Announced Insurance Coverage of 25-Hydroxyvitamin D Assay 211

7 Appendix 212

7.1 Methodology 212

7.2 About GlobalData 215

7.3 Contact Us 215

7.4 Disclaimer 215


List Of Figure

1.2 List of Figures

Figure 1: Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 10

Figure 2: Clinical Chemistry Analyzers-Pipeline Products by Segment 11

Figure 3: Clinical Chemistry Analyzers-Pipeline Products by Territory 12

Figure 4: Clinical Chemistry Analyzers-Pipeline Products by Regulatory Path 13

Figure 5: Clinical Chemistry Analyzers-Pipeline Products by Estimated Approval Date 14

Figure 6: Clinical Chemistry Analyzers-Ongoing Clinical Trials 15


List Of Table

1.1 List of Tables

Table 1: Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 10

Table 2: Clinical Chemistry Analyzers-Pipeline Products by Segment 11

Table 3: Clinical Chemistry Analyzers-Pipeline Products by Territory 12

Table 4: Clinical Chemistry Analyzers-Pipeline Products by Regulatory Path 13

Table 5: Clinical Chemistry Analyzers-Pipeline Products by Estimated Approval Date 14

Table 6: Clinical Chemistry Analyzers-Ongoing Clinical Trials 15

Table 7: Clinical Chemistry Analyzers Companies-Pipeline Products by Stage of Development 16

Table 8: Clinical Chemistry Analyzers-Pipeline Products by Stage of Development 18

Table 9: All Medicus Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 19

Table 10: Biosensor System-AST/ALT-Product Status 19

Table 11: Biosensor System-AST/ALT-Product Description 19

Table 12: Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 20

Table 13: Biolyzer 100-Product Status 20

Table 14: Biolyzer 100-Product Description 20

Table 15: Biolyzer 300-Product Status 21

Table 16: Biolyzer 300-Product Description 21

Table 17: Biolyzer 600-Product Status 21

Table 18: Biolyzer 600-Product Description 22

Table 19: Ativa Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 23

Table 20: Ativa Micro-Lab System-Product Status 23

Table 21: Ativa Micro-Lab System-Product Description 23

Table 22: Aviv Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

Table 23: Bili-4 Hematofluorometer-Product Status 24

Table 24: Bili-4 Hematofluorometer-Product Description 24

Table 25: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Table 26: DxC 700 AU-Product Status 25

Table 27: DxC 700 AU-Product Description 25

Table 28: Curetis NV Pipeline Products & Ongoing Clinical Trials Overview 26

Table 29: Unyvero Analyzer-Product Status 26

Table 30: Unyvero Analyzer-Product Description 27

Table 31: Daxor Corp Pipeline Products & Ongoing Clinical Trials Overview 28

Table 32: Total Blood Volume Analyzer-Total Body Albumin-Product Status 28

Table 33: Total Blood Volume Analyzer-Total Body Albumin-Product Description 28

Table 34: DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 29

Table 35: QDx Lipidcheck-Product Status 29

Table 36: QDx Lipidcheck-Product Description 29

Table 37: respons940-Product Status 30

Table 38: respons940-Product Description 30

Table 39: Emergent Detection Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

Table 40: BodyKey Fat Loss Sensor-Product Status 31

Table 41: BodyKey Fat Loss Sensor-Product Description 31

Table 42: Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 32

Table 43: Paper-Based Microfluidic Analytical System-Product Status 32

Table 44: Paper-Based Microfluidic Analytical System-Product Description 32

Table 45: Illumina, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

Table 46: LSD-100 Lysosomal Storage Enzyme Analyzer-Product Status 33

Table 47: LSD-100 Lysosomal Storage Enzyme Analyzer-Product Description 34

Table 48: Instrumentation Laboratory Company Pipeline Products & Ongoing Clinical Trials Overview 35

Table 49: GEM Premier 5000-Glucose/Lactate/Total Bilirubin-Product Status 35

Table 50: GEM Premier 5000-Glucose/Lactate/Total Bilirubin-Product Description 35

Table 51: GEM Premier 5000-Hemoglobin And Oxygen Saturation-Product Status 36

Table 52: GEM Premier 5000-Hemoglobin And Oxygen Saturation-Product Description 36

Table 53: GEM Premier 5000-pH/pCO2/pO2-Product Status 36

Table 54: GEM Premier 5000-pH/pCO2/pO2-Product Description 37

Table 55: GEM Premier 5000 System-Product Status 37

Table 56: GEM Premier 5000 System-Product Description 37

Table 57: Invivomon Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 38

Table 58: Miniature Analyzer-Product Status 38

Table 59: Miniature Analyzer-Product Description 38

Table 60: I-Sens Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 61: Blood Gas Analyzer-Product Status 39

Table 62: Blood Gas Analyzer-Product Description 39

Table 63: MyCartis NV Pipeline Products & Ongoing Clinical Trials Overview 40

Table 64: Evalution-Product Status 40

Table 65: Evalution-Product Description 40

Table 66: NanoIVD Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 67: NanoIVD Clinical Analyzer-I-Product Status 41

Table 68: NanoIVD Clinical Analyzer-I-Product Description 41

Table 69: National Institute of Biomedical Imaging and Bioengineering Pipeline Products & Ongoing Clinical Trials Overview 42

Table 70: Microfluidic Diagnostic Card-Product Status 42

Table 71: Microfluidic Diagnostic Card-Product Description 42

Table 72: NeuMoDx Molecular, Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 73: NeuMoDx 500 Molecular IVD System-Product Status 43

Table 74: NeuMoDx 500 Molecular IVD System-Product Description 43

Table 75: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 76: Claros 1 Analyzer-Product Status 44

Table 77: Claros 1 Analyzer-Product Description 44

Table 78: OPKO Health Inc-Ongoing Clinical Trials Overview 45

Table 79: Claros 1 Analyzer-Claros 1 Clinical Trial for Total PSA 46

Table 80: Samsung Electronics Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 47

Table 81: LABGEO PT10-Product Status 47

Table 82: LABGEO PT10-Product Description 48

Table 83: Smiths Detection Group Limited Pipeline Products & Ongoing Clinical Trials Overview 49

Table 84: Bio-Seeq-Clinical-Product Status 49

Table 85: Bio-Seeq-Clinical-Product Description 49

Table 86: The Hong Kong University of Science and Technology Pipeline Products & Ongoing Clinical Trials Overview 50

Table 87: Portable Real-time PCR System-Product Status 50

Table 88: Portable Real-time PCR System-Product Description 50

Table 89: Theranos Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Table 90: miniLab System-Product Status 51

Table 91: miniLab System-Product Description 51

Table 92: Thermal Gradient Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Table 93: Flash HT-Product Status 52

Table 94: Flash HT-Product Description 52

Table 95: Glossary 214

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Products

All Medicus Co Ltd, Biosensor System-AST/ALT; Analyticon Biotechnologies AG, Biolyzer 100; Analyticon Biotechnologies AG, Biolyzer 300; Analyticon Biotechnologies AG, Biolyzer 600; Ativa Medical Inc, Ativa Micro-Lab System; Aviv Biomedical, Inc., Bili-4 Hematofluorometer; Beckman Coulter Inc, DxC 700 AU; Curetis NV, Unyvero Analyzer; Daxor Corp, Total Blood Volume Analyzer-Total Body Albumin; DiaSys Diagnostic Systems GmbH, QDx Lipidcheck; DiaSys Diagnostic Systems GmbH, respons940; Emergent Detection Inc (Inactive), BodyKey Fat Loss Sensor; Hansjorg Wyss Institute for Biologically Inspired Engineering, Paper-Based Microfluidic Analytical System; Illumina, Inc., LSD-100 Lysosomal Storage Enzyme Analyzer; Instrumentation Laboratory Company, GEM Premier 5000-Glucose/Lactate/Total Bilirubin; Instrumentation Laboratory Company, GEM Premier 5000-Hemoglobin And Oxygen Saturation; Instrumentation Laboratory Company, GEM Premier 5000-pH/pCO2/pO2; Instrumentation Laboratory Company, GEM Premier 5000 System; Invivomon Inc (Inactive), Miniature Analyzer; I-Sens Inc, Blood Gas Analyzer; MyCartis NV, Evalution; NanoIVD Inc, NanoIVD Clinical Analyzer-I; National Institute of Biomedical Imaging and Bioengineering, Microfluidic Diagnostic Card; NeuMoDx Molecular, Inc, NeuMoDx 500 Molecular IVD System; OPKO Health Inc, Claros 1 Analyzer; Samsung Electronics Co., Ltd., LABGEO PT10; Smiths Detection Group Limited, Bio-Seeq-Clinical; The Hong Kong University of Science and Technology, Portable Real-time PCR System; Theranos Inc, miniLab System; Thermal Gradient Inc, Flash HT


Companies

All Medicus Co Ltd

Analyticon Biotechnologies AG

Ativa Medical Inc

Aviv Biomedical, Inc.

Beckman Coulter Inc

Curetis NV

Daxor Corp

DiaSys Diagnostic Systems GmbH

Emergent Detection Inc

Hansjorg Wyss Institute for Biologically Inspired Engineering

Illumina, Inc.

Instrumentation Laboratory Company

Invivomon Inc

I-Sens Inc

MyCartis NV

NanoIVD Inc

National Institute of Biomedical Imaging and Bioengineering

NeuMoDx Molecular, Inc

OPKO Health Inc

Samsung Electronics Co., Ltd.

Smiths Detection Group Limited

The Hong Kong University of Science and Technology

Theranos Inc

Thermal Gradient Inc