Clinical Chemistry Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Clinical Chemistry Pipeline Market Report Overview

Clinical Chemistry comprises reagents, test kits, and electrodes. This assists in determining the concentration or activity of biomolecules, such as proteins, carbohydrates, lipids, enzymes, minerals, or other small molecules. The Clinical Chemistry pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segments ·        Therapeutic Drug Monitoring

·        Clinical Chemistry Rapid Tests & POC

·        Immunosuppressant Therapeutic Drug Monitoring

·        Urine Analyzers

·        Antibiotic/Antivirus Therapeutic Drug Monitoring

Key Territories ·        The US

·        Europe

·        Canada

·        China

·        Australia

Key Regulatory Paths ·        510(K)

·        CE

·        TGA

·        MDL

·        NMPA

Leading Companies ·        20/20 GeneSystems Inc

·        2invest AG

·        A.Menarini Diagnostics Ltd

·        A/C Diagnostics LLC

·        Abbott Diagnostics

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Clinical Chemistry Pipeline Market by Segments

The key segments in the Clinical Chemistry pipeline market are Therapeutic Drug Monitoring, Troponin Point of Care (POC) Tests, Troponin Laboratory Tests, Brain Natriuretic Peptide (BNP) Point of Care (POC) Tests, and Brain Natriuretic Peptide (BNP) Laboratory Tests among others. As of December 2023, Therapeutic Drug Monitoring accounted for the highest number of pipeline products.

Clinical Chemistry Pipeline Market Analysis by Segments, 2023 (%)

Clinical Chemistry Pipeline Market Analysis by Segments, 2023 (%)

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Clinical Chemistry Pipeline Market Segmentation by Territories

A few of the key territories for Clinical Chemistry pipeline products are the US, Europe, Canada, China, and Australia among others. As of December 2023, the US accounted for the highest number of pipeline products.

Clinical Chemistry Pipeline Market Analysis by Territories, 2023 (%)

Clinical Chemistry Pipeline Market Analysis by Territories, 2023 (%)

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Clinical Chemistry Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the Clinical Chemistry pipeline market are 510(K), CE, TGA, MDL, and NMPA among others. As of December 2023, 510(K) was the most followed pathway for pipeline products in the market.

Clinical Chemistry Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Clinical Chemistry Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Clinical Chemistry Pipeline Market – Competitive Landscape

A few of the key companies associated with the Clinical Chemistry pipeline market are 20/20 GeneSystems Inc, 2invest AG, A.Menarini Diagnostics Ltd, A/C Diagnostics LLC, and Abbott Diagnostics among others.

Abbott Diagnostics (Abbott): Abbott is headquartered in Lake Forest, Illinois, the US. It is a manufacturer of in vitro diagnostic systems and tests. The company offers various core laboratory products, molecular POC products, transfusion medicine, professional services, and diagnostics. Abbott’s product portfolio includes laboratory systems for automation-molecular diagnostic systems and POC systems for blood analysis. The products are used in therapeutic drug monitoring, measurement of antibodies and antigens, and screening and diagnosis of cancer. Furthermore, Abbott serves blood banks, hospitals, commercial laboratories, government agencies, patient care testing sites, and plasma protein therapeutic companies.

Clinical Chemistry Pipeline Market Analysis by Companies, 2023

Clinical Chemistry Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Clinical Chemistry Pipeline Market Segments Outlook

  • Therapeutic Drug Monitoring
  • Troponin Point of Care (POC) Tests
  • Troponin Laboratory Tests
  • Brain Natriuretic Peptide (BNP) Point of Care (POC) Tests
  • Brain Natriuretic Peptide (BNP) Laboratory Tests

Clinical Chemistry Pipeline Market Territories Outlook

  • The US
  • Europe
  • Canada
  • China
  • Australia

Clinical Chemistry Pipeline Market Regulatory Paths Outlook

  • 510(K)
  • CE
  • TGA
  • MDL
  • NMPA

Scope

This report provides:

  • Extensive coverage of the Clinical Chemistry under development.
  • An exhaustive list of major pipeline products and their details, including product descriptions, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of Clinical Chemistry and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

  • Gather actionable insights from competitor information to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Clinical Chemistry under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • Carry out In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

20/20 GeneSystems Inc
2invest AG
A.Menarini Diagnostics Ltd
A/C Diagnostics LLC
Abbott Diagnostics
Abreos Biosciences Inc (Inactive)
ADA Technologies, Inc.
Adaptive Biotechnologies Corp
Advanced Biological Laboratories SA
Affinergy LLC
Alfa Wassermann Diagnostic Technologies, LLC
Alfa Wassermann Inc
Analyticon Biotechnologies AG
AnaZyme LLC
Angle Biosciences Inc
Animated Dynamics Inc
Ap Lifesciences LLC
Applied Research using OMIC Sciences SL
Arizona State University
ARK Diagnostics Inc
Astrego Diagnostics AB
Augurix SA
AutoGenomics Inc
Avacta Group Plc
Base Pair Biotechnologies Inc
Becton Dickinson and Co
BG Medicine Inc
Biocross SL
Bioftalmik Applied Research
BIOHOPE Scientific SL
BioMarin Pharmaceutical Inc
Bio-Rad Laboratories Inc
Biostarks Labs US Inc
Biotech Resources Aust Pty Ltd
Bisu Inc
Boditech Med Inc
Boston University
Burnet Institute
California Pacific Medical Center Research Institute
Calmark Sweden AB
Cambridge Diagnostic Imaging Ltd
Cambridge Nutranostics Ltd
Carclo Diagnostic Solutions Ltd
CardioGenics Inc
CCC Diagnostics LLC
Cellex Inc
Center for Biomedical Research Network in Bioengineering, Biomaterials and Nanomedicine
Centre Hospitalier Universitaire de Nice
Charite University Hospital of Berlin
Chemeleon Inc
China Sky One Medical Inc
Chromanostics Inc
Chronix Biomedical Inc
Claremont BioSolutions
Clemson University
Clinical Design Technologies Ltd
Cognizance Biomarkers LLC
Columbia University
ContraVac Inc (Inactive)
CytoVas LLC
Denovo Biolabs Pvt Ltd
DiaSys Diagnostic Systems GmbH
DNAPrint Genomics Inc (Inactive)
DoacLevel
Dublin City University
Ecole Polytechnique Federale de Lausanne
Edan Instruments Inc
EKF Diagnostics Holdings Plc
ELITechGroup Inc
Eone Diagnomics Genome Center Co Ltd
Eurobio Scientific SA
First Light Diagnostics Inc
Fluoresprobe Sciences LLC
Foundation for Innovative New Diagnostics
Gene Express, Inc. (Inactive)
genedrive plc
GenMark Diagnostics Inc
Giner Inc
GlucoSentient Inc
Group K Diagnostics
Guangzhou Wondfo Biotech Co Ltd
Healthmed Services Ltd. (Inactive)
Healthy io Ltd
Horiba Ltd
Imperial College London
In Vitro Diagnostic Solutions Inc
Indian Institute of Technology Delhi
Inflammatix Inc
Insilixa, Inc.
Instrumentation Laboratory Co
IPI Singapore
IR2Dx Inc.
IRIS International Inc
iXensor Co. Ltd.
Johns Hopkins University
Kalium Health Ltd
KIYATEC Inc
Kobe University
Kwandong University College of Medicine
L’epigeneMD Co Ltd
Laboratorios Rubio SA
LifeAssays AB
LumiraDx Ltd
Magee-Womens Research Institute
Massachusetts Institute of Technology
Medical Research Council
Medical University of South Carolina
Metabolon Inc
Miami VA Healthcare System
MiCo BioMed Co Ltd
Monash University
Montana State University
Mylab Discovery Solutions Pvt Ltd
Myotherapeutics LLC (Inactive)
NanoSpeed Diagnostics Inc
Newcastle University
Nipro Europe N.V.
Northeastern University
NTBIO Diagnostics Inc
Nuclea Biotechnologies Inc. (Inactive)
Ohmx Corp
OPKO Health Inc
Overture Life Inc
Oxford Immunotec Ltd
PanGenomic Health Inc
Pax Neuroscience Inc
Pelago Bioscience AB
Pennsylvania State University
Plateletdiagnostics LLC
PortaScience Inc
Predict Health LLC
Prediction Sciences LLC (Inactive)
PreventionGenetics LLC
Primogen Biotech Pvt Ltd
ProciseDx LLC
Progenika Biopharma SA
PrognosDx Health Inc
Prometheus Laboratories Inc
Proteomika (Inactive)
Purdue University
Qiagen NV
QSTAG Co Ltd
Queen Mary University of London
Quidel Corp
Raptamer Discovery Group LLC
redhot diagnostics AB
Roche Diagnostics Corp
Roche Diagnostics International Ltd
Rockland Immunochemicals Inc
SAGA Diagnostics AB
Saladax Biomedical Inc
SaltCheck Inc (Inactive)
Seattle Children's Hospital
Sebia
SenGenix Inc
Shenzhen Mindray Bio-Medical Electronics Co Ltd
Shilpa Medicare Ltd
Siemens Healthcare Diagnostics Inc
Singapore General Hospital
Sirius Genomics Inc
Spanish National Research Council
Specto Srl
SpinChip Diagnostics AS
SQI Diagnostics Inc
Stanford University
SuperNova Diagnostics, Inc.
Systagenix Wound Management Ltd
T2 Biosystems Inc
Teco Diagnostics
TestCard Ltd
The Chinese University of Hong Kong
The University of New South Wales press Limited
Thermo Fisher Scientific Inc
TrivarX Ltd
U.S. Army Medical Research and Development Command
Universal Biosensors Inc
Universidade Feevale
University of California Santa Cruz
University of Central Florida
University of Colorado
University of Colorado Denver
University of Edinburgh
University of Florida
University of Illinois at Chicago
University of Kentucky
University of Massachusetts Lowell
University of North Carolina at Chapel Hill
University of North Dakota
University of Queensland
University of Texas at Arlington
University of Washington
UrSure Inc
Vanderbilt University
Vanteres Pte Ltd
Virginia Polytechnic Institute and State University
Vyant Bio Inc
Withings SA

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 18

|1.2 List of Figures 36

2 Introduction 37

2.1 Clinical Chemistry Overview 37

3 Products under Development 38

3.1 Clinical Chemistry – Pipeline Products by Stage of Development 38

3.2 Clinical Chemistry – Pipeline Products by Segment 39

3.3 Clinical Chemistry – Pipeline Products by Territory 41

3.4 Clinical Chemistry – Pipeline Products by Regulatory Path 43

3.5 Clinical Chemistry – Pipeline Products by Estimated Approval Date 44

3.6 Clinical Chemistry – Ongoing Clinical Trials 45

4 Clinical Chemistry – Pipeline Products under Development by Companies 46

4.1 Clinical Chemistry Companies – Pipeline Products by Stage of Development 46

4.2 Clinical Chemistry – Pipeline Products by Stage of Development 54

5 Clinical Chemistry Companies and Product Overview 64

5.1 20/20 GeneSystems Inc Company Overview 64

5.1.1 20/20 GeneSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.2 2invest AG Company Overview 65

5.2.1 2invest AG Pipeline Products & Ongoing Clinical Trials Overview 65

5.3 A.Menarini Diagnostics Ltd Company Overview 66

5.3.1 A.Menarini Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

5.4 A/C Diagnostics LLC Company Overview 67

5.4.1 A/C Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 67

5.5 Abbott Diagnostics Company Overview 68

5.5.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 68

5.6 Abreos Biosciences Inc (Inactive) Company Overview 72

5.6.1 Abreos Biosciences Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 72

5.7 ADA Technologies, Inc. Company Overview 80

5.7.1 ADA Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80

5.8 Adaptive Biotechnologies Corp Company Overview 81

5.8.1 Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 81

5.9 Advanced Biological Laboratories SA Company Overview 82

5.9.1 Advanced Biological Laboratories SA Pipeline Products & Ongoing Clinical Trials Overview 82

5.10 Affinergy LLC Company Overview 84

5.10.1 Affinergy LLC Pipeline Products & Ongoing Clinical Trials Overview 84

5.11 Alfa Wassermann Diagnostic Technologies, LLC Company Overview 88

5.11.1 Alfa Wassermann Diagnostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 88

5.12 Alfa Wassermann Inc Company Overview 90

5.12.1 Alfa Wassermann Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.13 Analyticon Biotechnologies AG Company Overview 91

5.13.1 Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 91

5.14 AnaZyme LLC Company Overview 94

5.14.1 AnaZyme LLC Pipeline Products & Ongoing Clinical Trials Overview 94

5.15 Angle Biosciences Inc Company Overview 96

5.15.1 Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.16 Animated Dynamics Inc Company Overview 97

5.16.1 Animated Dynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 97

5.17 Ap Lifesciences LLC Company Overview 98

5.17.1 Ap Lifesciences LLC Pipeline Products & Ongoing Clinical Trials Overview 98

5.18 Applied Research using OMIC Sciences SL Company Overview 99

5.18.1 Applied Research using OMIC Sciences SL Pipeline Products & Ongoing Clinical Trials Overview 99

5.19 Arizona State University Company Overview 100

5.19.1 Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 100

5.20 ARK Diagnostics Inc Company Overview 101

5.20.1 ARK Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 101

5.21 Astrego Diagnostics AB Company Overview 114

5.21.1 Astrego Diagnostics AB Pipeline Products & Ongoing Clinical Trials Overview 114

5.22 Augurix SA Company Overview 116

5.22.1 Augurix SA Pipeline Products & Ongoing Clinical Trials Overview 116

5.23 AutoGenomics Inc Company Overview 117

5.23.1 AutoGenomics Inc Pipeline Products & Ongoing Clinical Trials Overview 117

5.24 Avacta Group Plc Company Overview 118

5.24.1 Avacta Group Plc Pipeline Products & Ongoing Clinical Trials Overview 118

5.25 Base Pair Biotechnologies Inc Company Overview 122

5.25.1 Base Pair Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 122

5.26 Becton Dickinson and Co Company Overview 123

5.26.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 123

5.27 BG Medicine Inc Company Overview 124

5.27.1 BG Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 124

5.28 Biocross SL Company Overview 128

5.28.1 Biocross SL Pipeline Products & Ongoing Clinical Trials Overview 128

5.29 Bioftalmik Applied Research Company Overview 130

5.29.1 Bioftalmik Applied Research Pipeline Products & Ongoing Clinical Trials Overview 130

5.30 BIOHOPE Scientific SL Company Overview 131

5.30.1 BIOHOPE Scientific SL Pipeline Products & Ongoing Clinical Trials Overview 131

5.31 BioMarin Pharmaceutical Inc Company Overview 134

5.31.1 BioMarin Pharmaceutical Inc Pipeline Products & Ongoing Clinical Trials Overview 134

5.32 Bio-Rad Laboratories Inc Company Overview 135

5.32.1 Bio-Rad Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.33 Biostarks Labs US Inc Company Overview 136

5.33.1 Biostarks Labs US Inc Pipeline Products & Ongoing Clinical Trials Overview 136

5.34 Biotech Resources Aust Pty Ltd Company Overview 138

5.34.1 Biotech Resources Aust Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

5.35 Bisu Inc Company Overview 139

5.35.1 Bisu Inc Pipeline Products & Ongoing Clinical Trials Overview 139

5.36 Boditech Med Inc Company Overview 141

5.36.1 Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 141

5.37 Boston University Company Overview 145

5.37.1 Boston University Pipeline Products & Ongoing Clinical Trials Overview 145

5.38 Burnet Institute Company Overview 146

5.38.1 Burnet Institute Pipeline Products & Ongoing Clinical Trials Overview 146

5.39 California Pacific Medical Center Research Institute Company Overview 147

5.39.1 California Pacific Medical Center Research Institute Pipeline Products & Ongoing Clinical Trials Overview 147

5.40 Calmark Sweden AB Company Overview 148

5.40.1 Calmark Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 148

5.41 Cambridge Diagnostic Imaging Ltd Company Overview 151

5.41.1 Cambridge Diagnostic Imaging Ltd Pipeline Products & Ongoing Clinical Trials Overview 151

5.42 Cambridge Nutranostics Ltd Company Overview 153

5.42.1 Cambridge Nutranostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 153

5.43 Carclo Diagnostic Solutions Ltd Company Overview 154

5.43.1 Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 154

5.44 CardioGenics Inc Company Overview 156

5.44.1 CardioGenics Inc Pipeline Products & Ongoing Clinical Trials Overview 156

5.45 CCC Diagnostics LLC Company Overview 157

5.45.1 CCC Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 157

5.46 Cellex Inc Company Overview 158

5.46.1 Cellex Inc Pipeline Products & Ongoing Clinical Trials Overview 158

5.47 Center for Biomedical Research Network in Bioengineering, Biomaterials and Nanomedicine Company Overview 159

5.47.1 Center for Biomedical Research Network in Bioengineering, Biomaterials and Nanomedicine Pipeline Products & Ongoing Clinical Trials Overview 159

5.48 Centre Hospitalier Universitaire de Nice Company Overview 160

5.48.1 Centre Hospitalier Universitaire de Nice Pipeline Products & Ongoing Clinical Trials Overview 160

5.49 Charite University Hospital of Berlin Company Overview 161

5.49.1 Charite University Hospital of Berlin Pipeline Products & Ongoing Clinical Trials Overview 161

5.50 Chemeleon Inc Company Overview 162

5.50.1 Chemeleon Inc Pipeline Products & Ongoing Clinical Trials Overview 162

5.51 China Sky One Medical Inc Company Overview 163

5.51.1 China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.52 Chromanostics Inc Company Overview 164

5.52.1 Chromanostics Inc Pipeline Products & Ongoing Clinical Trials Overview 164

5.53 Chronix Biomedical Inc Company Overview 165

5.53.1 Chronix Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 165

5.54 Claremont BioSolutions Company Overview 166

5.54.1 Claremont BioSolutions Pipeline Products & Ongoing Clinical Trials Overview 166

5.55 Clemson University Company Overview 167

5.55.1 Clemson University Pipeline Products & Ongoing Clinical Trials Overview 167

5.56 Clinical Design Technologies Ltd Company Overview 168

5.56.1 Clinical Design Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 168

5.57 Cognizance Biomarkers LLC Company Overview 169

5.57.1 Cognizance Biomarkers LLC Pipeline Products & Ongoing Clinical Trials Overview 169

5.58 Columbia University Company Overview 170

5.58.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 170

5.59 ContraVac Inc (Inactive) Company Overview 173

5.59.1 ContraVac Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 173

5.60 CytoVas LLC Company Overview 174

5.60.1 CytoVas LLC Pipeline Products & Ongoing Clinical Trials Overview 174

5.61 Denovo Biolabs Pvt Ltd Company Overview 175

5.61.1 Denovo Biolabs Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

5.62 DiaSys Diagnostic Systems GmbH Company Overview 177

5.62.1 DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 177

5.63 DNAPrint Genomics Inc (Inactive) Company Overview 178

5.63.1 DNAPrint Genomics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 178

5.64 DoacLevel Company Overview 181

5.64.1 DoacLevel Pipeline Products & Ongoing Clinical Trials Overview 181

5.65 Dublin City University Company Overview 182

5.65.1 Dublin City University Pipeline Products & Ongoing Clinical Trials Overview 182

5.66 Ecole Polytechnique Federale de Lausanne Company Overview 183

5.66.1 Ecole Polytechnique Federale de Lausanne Pipeline Products & Ongoing Clinical Trials Overview 183

5.67 Edan Instruments Inc Company Overview 184

5.67.1 Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 184

5.68 EKF Diagnostics Holdings Plc Company Overview 185

5.68.1 EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 185

5.69 ELITechGroup Inc Company Overview 186

5.69.1 ELITechGroup Inc Pipeline Products & Ongoing Clinical Trials Overview 186

5.70 Eone Diagnomics Genome Center Co Ltd Company Overview 191

5.70.1 Eone Diagnomics Genome Center Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 191

5.71 Eurobio Scientific SA Company Overview 193

5.71.1 Eurobio Scientific SA Pipeline Products & Ongoing Clinical Trials Overview 193

5.72 First Light Diagnostics Inc Company Overview 194

5.72.1 First Light Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 194

5.73 Fluoresprobe Sciences LLC Company Overview 195

5.73.1 Fluoresprobe Sciences LLC Pipeline Products & Ongoing Clinical Trials Overview 195

5.74 Foundation for Innovative New Diagnostics Company Overview 196

5.74.1 Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 196

5.75 Gene Express, Inc. (Inactive) Company Overview 197

5.75.1 Gene Express, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 197

5.76 genedrive plc Company Overview 199

5.76.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 199

5.77 GenMark Diagnostics Inc Company Overview 200

5.77.1 GenMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 200

5.78 Giner Inc Company Overview 202

5.78.1 Giner Inc Pipeline Products & Ongoing Clinical Trials Overview 202

5.79 GlucoSentient Inc Company Overview 203

5.79.1 GlucoSentient Inc Pipeline Products & Ongoing Clinical Trials Overview 203

5.80 Group K Diagnostics Company Overview 204

5.80.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 204

5.81 Guangzhou Wondfo Biotech Co Ltd Company Overview 207

5.81.1 Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 207

5.82 Healthmed Services Ltd. (Inactive) Company Overview 213

5.82.1 Healthmed Services Ltd. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 213

5.83 Healthy io Ltd Company Overview 214

5.83.1 Healthy io Ltd Pipeline Products & Ongoing Clinical Trials Overview 214

5.84 Horiba Ltd Company Overview 216

5.84.1 Horiba Ltd Pipeline Products & Ongoing Clinical Trials Overview 216

5.85 Imperial College London Company Overview 218

5.85.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 218

5.86 In Vitro Diagnostic Solutions Inc Company Overview 221

5.86.1 In Vitro Diagnostic Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 221

5.87 Indian Institute of Technology Delhi Company Overview 223

5.87.1 Indian Institute of Technology Delhi Pipeline Products & Ongoing Clinical Trials Overview 223

5.88 Inflammatix Inc Company Overview 224

5.88.1 Inflammatix Inc Pipeline Products & Ongoing Clinical Trials Overview 224

5.89 Insilixa, Inc. Company Overview 225

5.89.1 Insilixa, Inc. Pipeline Products & Ongoing Clinical Trials Overview 225

5.90 Instrumentation Laboratory Co Company Overview 226

5.90.1 Instrumentation Laboratory Co Pipeline Products & Ongoing Clinical Trials Overview 226

5.91 IPI Singapore Company Overview 229

5.91.1 IPI Singapore Pipeline Products & Ongoing Clinical Trials Overview 229

5.92 IR2Dx Inc. Company Overview 230

5.92.1 IR2Dx Inc. Pipeline Products & Ongoing Clinical Trials Overview 230

5.93 IRIS International Inc Company Overview 231

5.93.1 IRIS International Inc Pipeline Products & Ongoing Clinical Trials Overview 231

5.94 iXensor Co. Ltd. Company Overview 232

5.94.1 iXensor Co. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 232

5.95 Johns Hopkins University Company Overview 233

5.95.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 233

5.96 Kalium Health Ltd Company Overview 234

5.96.1 Kalium Health Ltd Pipeline Products & Ongoing Clinical Trials Overview 234

5.97 KIYATEC Inc Company Overview 235

5.97.1 KIYATEC Inc Pipeline Products & Ongoing Clinical Trials Overview 235

5.98 Kobe University Company Overview 238

5.98.1 Kobe University Pipeline Products & Ongoing Clinical Trials Overview 238

5.99 Kwandong University College of Medicine Company Overview 239

5.99.1 Kwandong University College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 239

5.100 L’epigeneMD Co Ltd Company Overview 240

5.100.1 L’epigeneMD Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 240

5.101 Laboratorios Rubio SA Company Overview 241

5.101.1 Laboratorios Rubio SA Pipeline Products & Ongoing Clinical Trials Overview 241

5.102 LifeAssays AB Company Overview 242

5.102.1 LifeAssays AB Pipeline Products & Ongoing Clinical Trials Overview 242

5.103 LumiraDx Ltd Company Overview 243

5.103.1 LumiraDx Ltd Pipeline Products & Ongoing Clinical Trials Overview 243

5.104 Magee-Womens Research Institute Company Overview 244

5.104.1 Magee-Womens Research Institute Pipeline Products & Ongoing Clinical Trials Overview 244

5.105 Massachusetts Institute of Technology Company Overview 245

5.105.1 Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 245

5.106 Medical Research Council Company Overview 246

5.106.1 Medical Research Council Pipeline Products & Ongoing Clinical Trials Overview 246

5.107 Medical University of South Carolina Company Overview 247

5.107.1 Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 247

5.108 Metabolon Inc Company Overview 248

5.108.1 Metabolon Inc Pipeline Products & Ongoing Clinical Trials Overview 248

5.109 Miami VA Healthcare System Company Overview 250

5.109.1 Miami VA Healthcare System Pipeline Products & Ongoing Clinical Trials Overview 250

5.110 MiCo BioMed Co Ltd Company Overview 251

5.110.1 MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 251

5.111 Monash University Company Overview 253

5.111.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 253

5.112 Montana State University Company Overview 255

5.112.1 Montana State University Pipeline Products & Ongoing Clinical Trials Overview 255

5.113 Mylab Discovery Solutions Pvt Ltd Company Overview 256

5.113.1 Mylab Discovery Solutions Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 256

5.114 Myotherapeutics LLC (Inactive) Company Overview 257

5.114.1 Myotherapeutics LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 257

5.115 NanoSpeed Diagnostics Inc Company Overview 258

5.115.1 NanoSpeed Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 258

5.116 Newcastle University Company Overview 259

5.116.1 Newcastle University Pipeline Products & Ongoing Clinical Trials Overview 259

5.117 Nipro Europe N.V. Company Overview 260

5.117.1 Nipro Europe N.V. Pipeline Products & Ongoing Clinical Trials Overview 260

5.118 Northeastern University Company Overview 261

5.118.1 Northeastern University Pipeline Products & Ongoing Clinical Trials Overview 261

5.119 NTBIO Diagnostics Inc Company Overview 262

5.119.1 NTBIO Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 262

5.120 Nuclea Biotechnologies Inc. (Inactive) Company Overview 263

5.120.1 Nuclea Biotechnologies Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 263

5.121 Ohmx Corp Company Overview 265

5.121.1 Ohmx Corp Pipeline Products & Ongoing Clinical Trials Overview 265

5.122 OPKO Health Inc Company Overview 271

5.122.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 271

5.123 Overture Life Inc Company Overview 272

5.123.1 Overture Life Inc Pipeline Products & Ongoing Clinical Trials Overview 272

5.124 Oxford Immunotec Ltd Company Overview 275

5.124.1 Oxford Immunotec Ltd Pipeline Products & Ongoing Clinical Trials Overview 275

5.125 PanGenomic Health Inc Company Overview 276

5.125.1 PanGenomic Health Inc Pipeline Products & Ongoing Clinical Trials Overview 276

5.126 Pax Neuroscience Inc Company Overview 277

5.126.1 Pax Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 277

5.127 Pelago Bioscience AB Company Overview 278

5.127.1 Pelago Bioscience AB Pipeline Products & Ongoing Clinical Trials Overview 278

5.128 Pennsylvania State University Company Overview 279

5.128.1 Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview 279

5.129 Plateletdiagnostics LLC Company Overview 282

5.129.1 Plateletdiagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 282

5.130 PortaScience Inc Company Overview 283

5.130.1 PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 283

5.131 Predict Health LLC Company Overview 284

5.131.1 Predict Health LLC Pipeline Products & Ongoing Clinical Trials Overview 284

5.132 Prediction Sciences LLC (Inactive) Company Overview 286

5.132.1 Prediction Sciences LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 286

5.133 PreventionGenetics LLC Company Overview 288

5.133.1 PreventionGenetics LLC Pipeline Products & Ongoing Clinical Trials Overview 288

5.134 Primogen Biotech Pvt Ltd Company Overview 289

5.134.1 Primogen Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 289

5.135 ProciseDx LLC Company Overview 290

5.135.1 ProciseDx LLC Pipeline Products & Ongoing Clinical Trials Overview 290

5.136 Progenika Biopharma SA Company Overview 293

5.136.1 Progenika Biopharma SA Pipeline Products & Ongoing Clinical Trials Overview 293

5.137 PrognosDx Health Inc Company Overview 294

5.137.1 PrognosDx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 294

5.138 Prometheus Laboratories Inc Company Overview 296

5.138.1 Prometheus Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 296

5.139 Proteomika (Inactive) Company Overview 302

5.139.1 Proteomika (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 302

5.140 Purdue University Company Overview 305

5.140.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 305

5.141 Qiagen NV Company Overview 306

5.141.1 Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 306

5.142 QSTAG Co Ltd Company Overview 307

5.142.1 QSTAG Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 307

5.143 Queen Mary University of London Company Overview 309

5.143.1 Queen Mary University of London Pipeline Products & Ongoing Clinical Trials Overview 309

5.144 Quidel Corp Company Overview 310

5.144.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 310

5.145 Raptamer Discovery Group LLC Company Overview 312

5.145.1 Raptamer Discovery Group LLC Pipeline Products & Ongoing Clinical Trials Overview 312

5.146 redhot diagnostics AB Company Overview 314

5.146.1 redhot diagnostics AB Pipeline Products & Ongoing Clinical Trials Overview 314

5.147 Roche Diagnostics Corp Company Overview 315

5.147.1 Roche Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 315

5.148 Roche Diagnostics International Ltd Company Overview 316

5.148.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 316

5.149 Rockland Immunochemicals Inc Company Overview 339

5.149.1 Rockland Immunochemicals Inc Pipeline Products & Ongoing Clinical Trials Overview 339

5.150 SAGA Diagnostics AB Company Overview 340

5.150.1 SAGA Diagnostics AB Pipeline Products & Ongoing Clinical Trials Overview 340

5.151 Saladax Biomedical Inc Company Overview 341

5.151.1 Saladax Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 341

5.152 SaltCheck Inc (Inactive) Company Overview 353

5.152.1 SaltCheck Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 353

5.153 Seattle Children’s Hospital Company Overview 354

5.153.1 Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 354

5.154 Sebia Company Overview 356

5.154.1 Sebia Pipeline Products & Ongoing Clinical Trials Overview 356

5.155 SenGenix Inc Company Overview 358

5.155.1 SenGenix Inc Pipeline Products & Ongoing Clinical Trials Overview 358

5.156 Shenzhen Mindray Bio-Medical Electronics Co Ltd Company Overview 360

5.156.1 Shenzhen Mindray Bio-Medical Electronics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 360

5.157 Shilpa Medicare Ltd Company Overview 361

5.157.1 Shilpa Medicare Ltd Pipeline Products & Ongoing Clinical Trials Overview 361

5.158 Siemens Healthcare Diagnostics Inc Company Overview 362

5.158.1 Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 362

5.159 Singapore General Hospital Company Overview 371

5.159.1 Singapore General Hospital Pipeline Products & Ongoing Clinical Trials Overview 371

5.160 Sirius Genomics Inc Company Overview 372

5.160.1 Sirius Genomics Inc Pipeline Products & Ongoing Clinical Trials Overview 372

5.161 Spanish National Research Council Company Overview 373

5.161.1 Spanish National Research Council Pipeline Products & Ongoing Clinical Trials Overview 373

5.162 Specto Srl Company Overview 375

5.162.1 Specto Srl Pipeline Products & Ongoing Clinical Trials Overview 375

5.163 SpinChip Diagnostics AS Company Overview 376

5.163.1 SpinChip Diagnostics AS Pipeline Products & Ongoing Clinical Trials Overview 376

5.164 SQI Diagnostics Inc Company Overview 377

5.164.1 SQI Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 377

5.165 Stanford University Company Overview 379

5.165.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 379

5.166 SuperNova Diagnostics, Inc. Company Overview 380

5.166.1 SuperNova Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 380

5.167 Systagenix Wound Management Ltd Company Overview 381

5.167.1 Systagenix Wound Management Ltd Pipeline Products & Ongoing Clinical Trials Overview 381

5.168 T2 Biosystems Inc Company Overview 382

5.168.1 T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 382

5.169 Teco Diagnostics Company Overview 383

5.169.1 Teco Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 383

5.170 TestCard Ltd Company Overview 384

5.170.1 TestCard Ltd Pipeline Products & Ongoing Clinical Trials Overview 384

5.171 The Chinese University of Hong Kong Company Overview 387

5.171.1 The Chinese University of Hong Kong Pipeline Products & Ongoing Clinical Trials Overview 387

5.172 The University of New South Wales press Limited Company Overview 388

5.172.1 The University of New South Wales press Limited Pipeline Products & Ongoing Clinical Trials Overview 388

5.173 Thermo Fisher Scientific Inc Company Overview 389

5.173.1 Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 389

5.174 TrivarX Ltd Company Overview 391

5.174.1 TrivarX Ltd Pipeline Products & Ongoing Clinical Trials Overview 391

5.175 U.S. Army Medical Research and Development Command Company Overview 394

5.175.1 U.S. Army Medical Research and Development Command Pipeline Products & Ongoing Clinical Trials Overview 394

5.176 Universal Biosensors Inc Company Overview 395

5.176.1 Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 395

5.177 Universidade Feevale Company Overview 396

5.177.1 Universidade Feevale Pipeline Products & Ongoing Clinical Trials Overview 396

5.178 University of California Santa Cruz Company Overview 397

5.178.1 University of California Santa Cruz Pipeline Products & Ongoing Clinical Trials Overview 397

5.179 University of Central Florida Company Overview 398

5.179.1 University of Central Florida Pipeline Products & Ongoing Clinical Trials Overview 398

5.180 University of Colorado Company Overview 399

5.180.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 399

5.181 University of Colorado Denver Company Overview 401

5.181.1 University of Colorado Denver Pipeline Products & Ongoing Clinical Trials Overview 401

5.182 University of Edinburgh Company Overview 402

5.182.1 University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 402

5.183 University of Florida Company Overview 404

5.183.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 404

5.184 University of Illinois at Chicago Company Overview 405

5.184.1 University of Illinois at Chicago Pipeline Products & Ongoing Clinical Trials Overview 405

5.185 University of Kentucky Company Overview 406

5.185.1 University of Kentucky Pipeline Products & Ongoing Clinical Trials Overview 406

5.186 University of Massachusetts Lowell Company Overview 407

5.186.1 University of Massachusetts Lowell Pipeline Products & Ongoing Clinical Trials Overview 407

5.187 University of North Carolina at Chapel Hill Company Overview 408

5.187.1 University of North Carolina at Chapel Hill Pipeline Products & Ongoing Clinical Trials Overview 408

5.188 University of North Dakota Company Overview 409

5.188.1 University of North Dakota Pipeline Products & Ongoing Clinical Trials Overview 409

5.189 University of Queensland Company Overview 410

5.189.1 University of Queensland Pipeline Products & Ongoing Clinical Trials Overview 410

5.190 University of Texas at Arlington Company Overview 411

5.190.1 University of Texas at Arlington Pipeline Products & Ongoing Clinical Trials Overview 411

5.191 University of Washington Company Overview 412

5.191.1 University of Washington Pipeline Products & Ongoing Clinical Trials Overview 412

5.192 UrSure Inc Company Overview 413

5.192.1 UrSure Inc Pipeline Products & Ongoing Clinical Trials Overview 413

5.193 Vanderbilt University Company Overview 417

5.193.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 417

5.194 Vanteres Pte Ltd Company Overview 418

5.194.1 Vanteres Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 418

5.195 Virginia Polytechnic Institute and State University Company Overview 419

5.195.1 Virginia Polytechnic Institute and State University Pipeline Products & Ongoing Clinical Trials Overview 419

5.196 Vyant Bio Inc Company Overview 420

5.196.1 Vyant Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 420

5.197 Withings SA Company Overview 421

5.197.1 Withings SA Pipeline Products & Ongoing Clinical Trials Overview 421

6 Clinical Chemistry- Recent Developments 422

6.1 Dec 12, 2023: Nusano to Host December 19 Virtual KOL Event on Emerging Trends in Radiotherapeutics 422

6.2 Dec 12, 2023: Genentech Announces Appointment of Ashley Magargee as Chief Executive Officer 423

6.3 Dec 05, 2023: Siemens Healthineers Appoints Vivek Kanade as New Head For Its Middle East and Africa Operations 423

6.4 Dec 04, 2023: Stefan Blomsterberg Appointed as New CEO of CELLINK Bioprinting AB 423

6.5 Dec 04, 2023: UCF Welcomes Alum and Distinguished Military Leader as Associate VP of Federal Affairs 424

6.6 Dec 04, 2023: Inventia Life Science Announces Third Dimension Grant for 3D Cell Culture Research 424

6.7 Nov 30, 2023: Wilmot L. Matthews Announces Resignation as Director of SQI Diagnostics Debt Forgiveness, Voting Trust Agreement and Related Transactions 425

6.8 Nov 28, 2023: Thermo Fisher Scientific Prices Offering Of $2.5 Bln Of Senior Notes 426

6.9 Nov 27, 2023: Accelerate Diagnostics Announces Collaboration for the Use of the Arc System in Combination With Bruker´s MALDI Biotyper 426

6.10 Nov 27, 2023: Siemens Appoints Hakan Ozdemir as CEO of Smart Infrastructure in the Middle East 427

6.11 Nov 23, 2023: Cambridge Nutritional Sciences Reports Earnings Results for the Half Year Ended September 30, 2023 427

6.12 Nov 22, 2023: Biohit Renews Its Strategy to Accelerate Profitable Growth Changes in the Management Team 427

6.13 Nov 21, 2023: BD Names Dr. Ronald Silverman as Chief Medical Officer 428

6.14 Nov 21, 2023: UK Medical Devices Regulations: TUV Rheinland is now a UK Approved Body according to UK MDR 428

6.15 Nov 17, 2023: Pangenomic Health Subsidiary Announces First Sale of BDNF Biomarker Tests 429

6.16 Nov 14, 2023: MilliporeSigma Launches ChemisTwin, First Ever Digital Reference Material Platform for Analytical Testing 429

6.17 Nov 14, 2023: International Isotopes Announces Fiscal Results for the Third Quarter and First Nine Months of 2023 430

6.18 Nov 14, 2023: BD to Present at the 6th Annual Evercore ISI HealthCONx Conference 431

6.19 Nov 08, 2023: ThermoGenesis Holdings to Announce Financial Results for the Third Quarter Ended September 30, 2023, and Provide a Corporate Strategic Update 431

6.20 Nov 07, 2023: Abbott Laboratories Receives Additional 510(K) Clearance for i-STAT CG8+ cartridge with the i-STAT 1 System 431

6.21 Nov 07, 2023: Abbott Laboratories Receive Additional 510(K) Clearance for i-STAT CG8+ cartridge with the i-STAT 1 System 432

6.22 Nov 07, 2023: Abbott Laboratories Received Additional 510(K) Clearance for i-STAT CG8+ cartridge with the i-STAT 1 System 432

6.23 Nov 07, 2023: Calmark Ships Instruments to India for a Method Comparison Study 432

6.24 Nov 07, 2023: Summit Therapeutics Reports Financial Results and Operational Progress for the Third Quarter and Nine Months Ended September 30, 2023 433

6.25 Nov 07, 2023: Asahi Kasei Announces Consolidated Results for 1st and 2nd Quarter Fiscal 2023: April 1, 2023 – September 30, 2023 434

6.26 Nov 03, 2023: Telesis Bio Announces Commercial Release of Cell-free Amplification Kit for Generation of Transfection-scale DNA 434

6.27 Nov 02, 2023: Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2023 Financial and Operational Results 435

6.28 Nov 01, 2023: Kyowa Kirin Announces Results Presentation Fiscal 2023 Third Quarter 438

6.29 Nov 01, 2023: IDEXX Laboratories Announces Third Quarter Results 438

6.30 Oct 31, 2023: Samsung Electronics Reports Q3 2023 Results 440

6.31 Oct 30, 2023: Revvity Announces Financial Results for the Third Quarter of 2023 444

6.32 Oct 27, 2023: Tokuyama Corp Announces Consolidated Financial Statements for the Second Quarter Fiscal 2023 446

6.33 Oct 27, 2023: Clario’s Precision Motion Opal Technology Powers University of Oxford Breakthrough in Parkinson’s Disease 447

6.34 Oct 26, 2023: AddLife Interim Report 1 January – 30 September 2023 447

6.35 Oct 26, 2023: AddLife Announces Interim Report 1 January – 30 September 2023 448

6.36 Oct 26, 2023: Summit Therapeutics to Host Q3 2023 Financial Results & Operational Progress Call on November 7, 2023 448

6.37 Oct 24, 2023: Waters Announces Resignation of Jonathan Pratt as Senior Vice President of the Waters Division 449

6.38 Oct 19, 2023: H. Jack West, MD, Renowned Oncologist & Lung Cancer Expert, Joins Summit Therapeutics as Vice President of Clinical Development 449

6.39 Oct 19, 2023: bioMérieux Makes Strategic Investment in Oxford Nanopore 449

6.40 Oct 18, 2023: Abbott Reports Third-Quarter 202

Table

Clinical Chemistry – Pipeline Products by Stage of Development 38

Clinical Chemistry – Pipeline Products by Segment 39

Clinical Chemistry – Pipeline Products by Territory 41

Clinical Chemistry – Pipeline Products by Regulatory Path 43

Clinical Chemistry – Pipeline Products by Estimated Approval Date 44

Clinical Chemistry – Ongoing Clinical Trials 45

Clinical Chemistry Companies – Pipeline Products by Stage of Development 46

Clinical Chemistry – Pipeline Products by Stage of Development 54

20/20 GeneSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 64

PredicTOR Breast Test – Product Status 64

PredicTOR Breast Test – Product Description 64

2invest AG Pipeline Products & Ongoing Clinical Trials Overview 65

Lyophilized Kit – Product Status 65

Lyophilized Kit – Product Description 65

A.Menarini Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

Sedimax Lite – Product Status 66

Sedimax Lite – Product Description 66

A/C Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 67

Folate Enzymatic Assay – Product Status 67

Folate Enzymatic Assay – Product Description 67

Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 68

ARCHITECT c4000 System – Ca 72.2 Assay – Product Status 68

ARCHITECT c4000 System – Ca 72.2 Assay – Product Description 68

ARCHITECT c8000 System – Ca 72.2 Assay – Product Status 69

ARCHITECT c8000 System – Ca 72.2 Assay – Product Description 69

ARCHITECT ci16200 Integrated System – Ca 72.2 Assay – Product Status 69

ARCHITECT ci16200 Integrated System – Ca 72.2 Assay – Product Description 69

ARCHITECT ci8200 Integrated System – Ca 72.2 Assay – Product Status 70

ARCHITECT ci8200 Integrated System – Ca 72.2 Assay – Product Description 70

Methotrexate Chemiluminescent Assay – Product Status 70

Methotrexate Chemiluminescent Assay – Product Description 70

Zinc Assay – Product Status 71

Zinc Assay – Product Description 71

Abreos Biosciences Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 72

Veritope ELISA Based Immunoassay – Natalizumab – Product Status 72

Veritope ELISA Based Immunoassay – Natalizumab – Product Description 73

Veritope Lateral Flow Immunoassay – Adalimumab – Product Status 73

Veritope Lateral Flow Immunoassay – Adalimumab – Product Description 73

Veritope Lateral Flow Immunoassay – Cetuximab – Product Status 74

Veritope Lateral Flow Immunoassay – Cetuximab – Product Description 74

Veritope Lateral Flow Immunoassay – Daratumumab – Product Status 74

Veritope Lateral Flow Immunoassay – Daratumumab – Product Description 75

Veritope Lateral Flow Immunoassay – Eculizumab – Product Status 75

Veritope Lateral Flow Immunoassay – Eculizumab – Product Description 75

Veritope Lateral Flow Immunoassay – Infliximab – Product Status 76

Veritope Lateral Flow Immunoassay – Infliximab – Product Description 76

Veritope Lateral Flow Immunoassay – Nivolumab – Product Status 76

Veritope Lateral Flow Immunoassay – Nivolumab – Product Description 77

Veritope Lateral Flow Immunoassay – Pertuzumab – Product Status 77

Veritope Lateral Flow Immunoassay – Pertuzumab – Product Description 77

Veritope Lateral Flow Immunoassay – Ramucirumab – Product Status 78

Veritope Lateral Flow Immunoassay – Ramucirumab – Product Description 78

Veritope Lateral Flow Immunoassay – Tocilizumab – Product Status 78

Veritope Lateral Flow Immunoassay – Tocilizumab – Product Description 79

ADA Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80

Home Lithium Monitor – Product Status 80

Home Lithium Monitor – Product Description 80

Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 81

Immune System Profiling – Measure Of Vaccine Efficacy – Product Status 81

Immune System Profiling – Measure Of Vaccine Efficacy – Product Description 81

Advanced Biological Laboratories SA Pipeline Products & Ongoing Clinical Trials Overview 82

Bacteriology Typing And Drug Resistance Reagent – Product Status 82

Bacteriology Typing And Drug Resistance Reagent – Product Description 82

HCV Drug Resistance Reagent – Product Status 83

HCV Drug Resistance Reagent – Product Description 83

Affinergy LLC Pipeline Products & Ongoing Clinical Trials Overview 84

EVR TDM Assay – Product Status 84

EVR TDM Assay – Product Description 84

Locking Assay – Posaconazole – Product Status 85

Locking Assay – Posaconazole – Product Description 85

Phage-Based Assay – Product Status 85

Phage-Based Assay – Product Description 86

Point-Of-Care Lateral Flow Assay – Tacrolimus – Product Status 86

Point-Of-Care Lateral Flow Assay – Tacrolimus – Product Description 86

Point-Of-Care Lateral Flow Assay – Vancomycin – Product Status 87

Point-Of-Care Lateral Flow Assay – Vancomycin – Product Description 87

Alfa Wassermann Diagnostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 88

ACE Alera Clinical Chemistry System – Neonatal Bilirubin Assay – Product Status 88

ACE Alera Clinical Chemistry System – Neonatal Bilirubin Assay – Product Description 88

ACE Axcel Clinical Chemistry System – Enzyme Creatinine Assay – Product Status 89

ACE Axcel Clinical Chemistry System – Enzyme Creatinine Assay – Product Description 89

ACE Axcel System – Enzymatic Creatinine Assay – Product Status 89

ACE Axcel System – Enzymatic Creatinine Assay – Product Description 89

Alfa Wassermann Inc Pipeline Products & Ongoing Clinical Trials Overview 90

ACE Alera Clinical Chemistry System – Enzymatic Creatinine – Product Status 90

ACE Alera Clinical Chemistry System – Enzymatic Creatinine – Product Description 90

Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 91

Fluitest BIL – Total VBM Reagent – Product Status 91

Fluitest BIL – Total VBM Reagent – Product Description 91

Urilyzer 100 Pro – Product Status 92

Urilyzer 100 Pro – Product Description 92

Urilyzer 500 Pro – Product Status 92

Urilyzer 500 Pro – Product Description 93

AnaZyme LLC Pipeline Products & Ongoing Clinical Trials Overview 94

Blood-Based Assay – Absence Of Specific Compounds – Product Status 94

Blood-Based Assay – Absence Of Specific Compounds – Product Description 94

Blood-Based Assay – Specific Enzymes – Product Status 95

Blood-Based Assay – Specific Enzymes – Product Description 95

Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 96

Point-Of-Care Diagnostic Test – TBI – Product Status 96

Point-Of-Care Diagnostic Test – TBI – Product Description 96

Animated Dynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 97

ONCO4D Assay – Product Status 97

ONCO4D Assay – Product Description 97

Ap Lifesciences LLC Pipeline Products & Ongoing Clinical Trials Overview 98

POC Oxalate Monitoring Dipstick Test – Product Status 98

POC Oxalate Monitoring Dipstick Test – Product Description 98

Applied Research using OMIC Sciences SL Pipeline Products & Ongoing Clinical Trials Overview 99

SNP-Test – Product Status 99

SNP-Test – Product Description 99

Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 100

Diagnostic Assay – Osteoporosis – Product Status 100

Diagnostic Assay – Osteoporosis – Product Description 100

ARK Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 101

ARK Apixaban Assay – Product Status 101

ARK Apixaban Assay – Product Description 102

ARK Atazanavir Assay – Product Status 102

ARK Atazanavir Assay – Product Description 102

ARK Dabigatran Assay – Product Status 103

ARK Dabigatran Assay – Product Description 103

ARK Darunavir Assay – Product Status 103

ARK Darunavir Assay – Product Description 104

ARK Dolutegravir Assay – Product Status 104

ARK Dolutegravir Assay – Product Description 104

ARK Edoxaban Assay – Product Status 105

ARK Edoxaban Assay – Product Description 105

ARK High Sensitivity Opiates Assay – Product Status 105

ARK High Sensitivity Opiates Assay – Product Description 106

ARK Indinavir Assay – Product Status 106

ARK Indinavir Assay – Product Description 106

ARK Lopinavir Assay – Product Status 107

ARK Lopinavir Assay – Product Description 107

ARK Maraviroc Assay – Product Status 107

ARK Maraviroc Assay – Product Description 108

ARK Nelfinavir Assay – Product Status 108

ARK Nelfinavir Assay – Product Description 108

ARK Nevirapine Assay – Product Status 109

ARK Nevirapine Assay – Product Description 109

ARK Perampanel Assay – Product Status 109

ARK Perampanel Assay – Product Description 110

ARK Rivaroxaban Assay – Product Status 110

ARK Rivaroxaban Assay – Product Description 110

ARK Saquinavir Assay – Product Status 111

ARK Saquinavir Assay – Product Description 111

ARK Tiagabine Assay – Product Status 111

ARK Tiagabine Assay – Product Description 112

ARK Zolpidem Assay – Product Status 112

ARK Zolpidem Assay – Product Description 112

ARK Zopiclone Assay – Product Status 113

ARK Zopiclone Assay – Product Description 113

Astrego Diagnostics AB Pipeline Products & Ongoing Clinical Trials Overview 114

PA-100 Analyser With PA AST Panel U-0501 – Product Status 114

PA-100 Analyser With PA AST Panel U-0501 – Product Description 115

Augurix SA Pipeline Products & Ongoing Clinical Trials Overview 116

AUG-POC5 – Product Status 116

AUG-POC5 – Product Description 116

AutoGenomics Inc Pipeline Products & Ongoing Clinical Trials Overview 117

Plavix Panel Test – Product Status 117

Plavix Panel Test – Product Description 117

Avacta Group Plc Pipeline Products & Ongoing Clinical Trials Overview 118

Depression Test – Product Status 118

Depression Test – Product Description 118

Diagnostic Assay – Alzheimer’s Disease – Product Status 119

Diagnostic Assay – Alzheimer’s Disease – Product Description 119

Diagnostic Test – ADHD – Product Status 119

Diagnostic Test – ADHD – Product Description 120

Diagnostic Test – Bipolar Disorder – Product Status 120

Diagnostic Test – Bipolar Disorder – Product Description 120

Schizophrenia Response Test – Product Status 121

Schizophrenia Response Test – Product Description 121

Schizophrenia Side Effects Test – Product Status 121

Schizophrenia Side Effects Test – Product Description 121

Base Pair Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 122

Point-of-Care Tuberculosis Measurement System – Product Status 122

Point-of-Care Tuberculosis Measurement System – Product Description 122

Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 123

BD Phoenix – Dual AST Panel – Product Status 123

BD Phoenix – Dual AST Panel – Product Description 123

BG Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 124

Avandia Response – Product Status 124

Avandia Response – Product Description 124

Biomarker Test – Enbrel – Product Status 125

Biomarker Test – Enbrel – Product Description 125

Biomarker Test – Humira – Product Status 125

Biomarker Test – Humira – Product Description 126

Biomarker Test – Remicade – Product Status 126

Biomarker Test – Remicade – Product Description 126

LipidDx – Product Status 127

LipidDx – Product Description 127

Biocross SL Pipeline Products & Ongoing Clinical Trials Overview 128

AD Dementia Test – Product Status 128

AD Dementia Test – Product Description 128

Degenerative Dementia Test – Product Status 129

Degenerative Dementia Test – Product Description 129

Bioftalmik Applied Research Pipeline Products & Ongoing Clinical Trials Overview 130

Diagnostic Test – Pediatric Ocular Allergy – Product Status 130

Diagnostic Test – Pediatric Ocular Allergy – Product Description 130

BIOHOPE Scientific SL Pipeline Products & Ongoing Clinical Trials Overview 131

Immunobiogram – Renal Transplantation – Product Status 131

Immunobiogram – Renal Transplantation – Product Description 131

BIOHOPE Scientific SL – Ongoing Clinical Trials Overview 132

Immunobiogram – Renal Transplantation – Longitudinal Observational Study to Determine the Correlation Between Patient’s Pharmacodynamic Response to Immunosuppressants Measured in Vitro with IMMUNOBIOGRAM and of Rejection in Graft Biopsies in Patients with Renal Transplantation 133

BioMarin Pharmaceutical Inc Pipeline Products & Ongoing Clinical Trials Overview 134

Hand Held Blood Phe Monitor – Product Status 134

Hand Held Blood Phe Monitor – Product Description 134

Bio-Rad Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 135

Multiplexed Mutation Detection Assay – Therapy Selection – Product Status 135

Multiplexed Mutation Detection Assay – Therapy Selection – Product Description 135

Biostarks Labs US Inc Pipeline Products & Ongoing Clinical Trials Overview 136

Base Longevity At Home Test-Kit – Product Status 136

Base Longevity At Home Test-Kit – Product Description 136

Premium Longevity At Home Test-Kit – Product Status 137

Premium Longevity At Home Test-Kit – Product Description 137

Biotech Resources Aust Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

ATR-FTIR System – Glucose and Urea – Product Status 138

ATR-FTIR System – Glucose and Urea – Product Description 138

Bisu Inc Pipeline Products & Ongoing Clinical Trials Overview 139

Bisu Body Coach – Product Status 139

Bisu Body Coach – Product Description 139

Fertility Test Stick – Product Status 140

Fertility Test Stick – Product Description 140

Oral Health Test Stick – Product Status 140

Oral Health Test Stick – Product Description 140

Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 141

Ichroma 10 – Anti-Infliximab Assay – Product Status 141

Ichroma 10 – Anti-Infliximab Assay – Product Description 142

Ichroma 10 – Infliximab Assay – Product Status 142

Ichroma 10 – Infliximab Assay – Product Description 142

Ichroma II – Anti-Infliximab Assay – Product Status 143

Ichroma II – Anti-Infliximab Assay – Product Description 143

Ichroma III – Anti-Infliximab Assay – Product Status 143

Ichroma III – Anti-Infliximab Assay – Product Description 144

Ichroma III – Infliximab Assay – Product Status 144

Ichroma III – Infliximab Assay – Product Description 144

Boston University Pipeline Products & Ongoing Clinical Trials Overview 145

ELISA Assay – Tenofovir – Product Status 145

ELISA Assay – Tenofovir – Product Description 145

Burnet Institute Pipeline Products & Ongoing Clinical Trials Overview 146

G6PD POC Diagnostic Test – Product Status 146

G6PD POC Diagnostic Test – Product Description 146

California Pacific Medical Center Research Institute Pipeline Products & Ongoing Clinical Trials Overview 147

Urinary Proteome Monitoring Assay – Product Status 147

Urinary Proteome Monitoring Assay – Product Description 147

Calmark Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 148

Neo – Glucose – Product Status 148

Neo – Glucose – Product Description 148

Neo – LDH – Product Status 149

Neo – LDH – Product Description 149

Neo-Bilirubin – Product Status 149

Neo-Bilirubin – Product Description 150

Cambridge Diagnostic Imaging Ltd Pipeline Products & Ongoing Clinical Trials Overview 151

OCCL Test – Product Status 151

OCCL Test – Product Description 151

OCCL Test – Dementia – Product Status 152

OCCL Test – Dementia – Product Description 152

Cambridge Nutranostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 153

OCCL Pregnancy Health Test – Product Status 153

OCCL Pregnancy Health Test – Product Description 153

Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 154

Micropoc-CAT – Haemotology Assay – Product Status 154

Micropoc-CAT – Haemotology Assay – Product Description 154

Micropoc-CAT – Inflammation Assay – Product Status 155

Micropoc-CAT – Inflammation Assay – Product Description 155

CardioGenics Inc Pipeline Products & Ongoing Clinical Trials Overview 156

Plasminogen Activator Inhibitor Type-1 Test – Product Status 156

Plasminogen Activator Inhibitor Type-1 Test – Product Description 156

CCC Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 157

DirectHit Drug Response Indicator Test Panel – Gastrointestinal Cancer – Product Status 157

DirectHit Drug Response Indicator Test Panel – Gastrointestinal Cancer – Product Description 157

Cellex Inc Pipeline Products & Ongoing Clinical Trials Overview 158

Point-Of-Care Test – Bacterial Vaginosis – Product Status 158

Point-Of-Care Test – Bacterial Vaginosis – Product Description 158

Center for Biomedical Research Network in Bioengineering, Biomaterials and Nanomedicine Pipeline Products & Ongoing Clinical Trials Overview 159

Antibody Based Diagnostic Assay – Anticoagulants – Product Status 159

Antibody Based Diagnostic Assay – Anticoagulants – Product Description 159

Centre Hospitalier Universitaire de Nice Pipeline Products & Ongoing Clinical Trials Overview 160

Azacitidine Resistance Assay – Product Status 160

Azacitidine Resistance Assay – Product Description 160

Charite University Hospital of Berlin Pipeline Products & Ongoing Clinical Trials Overview 161

eNAD+ Detection Assay – Product Status 161

eNAD+ Detection Assay – Product Description 161

Chemeleon Inc Pipeline Products & Ongoing Clinical Trials Overview 162

Colorimetric Test Strip Biosensor – Product Status 162

Colorimetric Test Strip Biosensor – Product Description 162

China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 163

Semi-Quantitative Test Of Calcium Ion – Product Status 163

Semi-Quantitative Test Of Calcium Ion – Product Description 163

Chromanostics Inc Pipeline Products & Ongoing Clinical Trials Overview 164

Micronutrient Diagnostic Test – Product Status 164

Micronutrient Diagnostic Test – Product Description 164

Chronix Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 165

Therapeutic Monitoring Test – Pancreatic Cancer – Product Status 165

Therapeutic Monitoring Test – Pancreatic Cancer – Product Description 165

Claremont BioSolutions Pipeline Products & Ongoing Clinical Trials Overview 166

Integrated Disposable Assay – Clostridium Difficile – Product Status 166

Integrated Disposable Assay – Clostridium Difficile – Product Description 166

Clemson University Pipeline Products & Ongoing Clinical Trials Overview 167

Capillary – Channeled POC Device – Product Status 167

Capillary – Channeled POC Device – Product Description 167

Clinical Design Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 168

Urine Testing System – Product Status 168

Urine Testing System – Product Description 168

Cognizance Biomarkers LLC Pipeline Products & Ongoing Clinical Trials Overview 169

Blood Assay – mTOR Signaling – Product Status 169

Blood Assay – mTOR Signaling – Product Description 169

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 170

Diagnostic Assay – Acetylcholinesterase (AChE) Activity – Product Status 170

Diagnostic Assay – Acetylcholinesterase (AChE) Activity – Product Description 170

Diagnostic Test – Periodontal Disease – Product Status 171

Diagnostic Test – Periodontal Disease – Product Description 171

Protein Biomarker Test – Tuberculosis – Product Status 171

Protein Biomarker Test – Tuberculosis – Product Description 172

ContraVac Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 173

SpermCheck – Contraception – Product Status 173

SpermCheck – Contraception – Product Description 173

CytoVas LLC Pipeline Products & Ongoing Clinical Trials Overview 174

Vascular Health Profile – Product Status 174

Vascular Health Profile – Product Description 174

Denovo Biolabs Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

DeQuanto CHO HCP ELISA KIT – Product Status 175

DeQuanto CHO HCP ELISA KIT – Product Description 175

DeQuanto Trastuzumab (Herceptin) PK ELISA KIT – Product Status 175

DeQuanto Trastuzumab (Herceptin) PK ELISA KIT – Product Description 176

DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 177

Point-Of-Care Diagnostic Assay – CRP – Product Status 177

Point-Of-Care Diagnostic Assay – CRP – Product Description 177

DNAPrint Genomics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 178

Acenome – Product Status 178

Acenome – Product Description 178

Melphalan/Topotecan Response Test – Product Status 179

Melphalan/Topotecan Response Test – Product Description 179

Statinome – Product Status 179

Statinome – Product Description 180

DoacLevel Pipeline Products & Ongoing Clinical Trials Overview 181

Graphene Nanosensor – Product Status 181

Graphene Nanosensor – Product Description 181

Dublin City University Pipeline Products & Ongoing Clinical Trials Overview 182

Biomarker Based Test – Multiple Myeloma – Product Status 182

Biomarker Based Test – Multiple Myeloma – Product Description 182

Ecole Polytechnique Federale de Lausanne Pipeline Products & Ongoing Clinical Trials Overview 183

Portable Biosensor – Product Status 183

Portable Biosensor – Product Description 183

Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 184

i15 – BUN/Urea and Creatinine Test – Product Status 184

i15 – BUN/Urea and Creatinine Test – Product Description 184

EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 185

ß-Hydroxybutyrate LiquiColor Reagent – Product Status 185

ß-Hydroxybutyrate LiquiColor Reagent – Product Description 185

ELITechGroup Inc Pipeline Products & Ongoing Clinical Trials Overview 186

Eon 300 Automated Chemistry Analyzer – TxB Cardio Assay – Product Status 186

Eon 300 Automated Chemistry Analyzer – TxB Cardio Assay – Product Description 186

Eon Digoxin Assay – Product Status 187

Eon Digoxin Assay – Product Description 187

Eon Theophylline Assay – Product Status 187

Eon Theophylline Assay – Product Description 187

Phenobarbital Assay – Product Status 188

Phenobarbital Assay – Product Description 188

Phenytoin Assay – Product Status 188

Phenytoin Assay – Product Description 188

Selectra ProM Chemistry System – TxB Cardio Assay – Product Status 189

Selectra ProM Chemistry System – TxB Cardio Assay – Product Description 189

Selectra ProS Chemistry System – TxB Cardio Assay – Product Status 189

Selectra ProS Chemistry System – TxB Cardio Assay – Product Description 190

Eone Diagnomics Genome Center Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 191

Uriwell – Product Status 191

Uriwell – Product Description 192

Eurobio Scientific SA Pipeline Products & Ongoing Clinical Trials Overview 193

Therapeutic Drug Monitoring Test – Resistant Cancer – Product Status 193

Therapeutic Drug Monitoring Test – Resistant Cancer – Product Description 193

First Light Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 194

MultiPath Immunoreagent – UTI – Product Status 194

MultiPath Immunoreagent – UTI – Product Description 194

Fluoresprobe Sciences LLC Pipeline Products & Ongoing Clinical Trials Overview 195

UBCheck Assay – Product Status 195

UBCheck Assay – Product Description 195

Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 196

Protein Antigen Capture Assay – Buruli Ulcer – Product Status 196

Protein Antigen Capture Assay – Buruli Ulcer – Product Description 196

Gene Express, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 197

Cisplatin Chemoresistance Test – Product Status 197

Cisplatin Chemoresistance Test – Product Description 197

Prognostic Test – Irinotecan Chemoresistance – Product Status 198

Prognostic Test – Irinotecan Chemoresistance – Product Description 198

genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 199

Genedrive CYP2C19 ID Kit – Product Status 199

Genedrive CYP2C19 ID Kit – Product Description 199

GenMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 200

2D6 Tamoxifen Metabolism Test – Product Status 200

2D6 Tamoxifen Metabolism Test – Product Description 200

eSensor 2C19 Genotyping Test – Product Status 201

eSensor 2C19 Genotyping Test – Product Description 201

Giner Inc Pipeline Products & Ongoing Clinical Trials Overview 202

Home Based Blood Sodium Test – Product Status 202

Home Based Blood Sodium Test – Product Description 202

GlucoSentient Inc Pipeline Products & Ongoing Clinical Trials Overview 203

Point-Of-Care Screening Assay – Therapeutic Drug Monitoring – Product Status 203

Point-Of-Care Screening Assay – Therapeutic Drug Monitoring – Product Description 203

Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 204

KromaHealth Kit – Comprehensive Metabolic Panel Test – Product Status 204

KromaHealth Kit – Comprehensive Metabolic Panel Test – Product Description 204

KromaHealth Kit – Lipid Panel – Product Status 205

KromaHealth Kit – Lipid Panel – Product Description 205

Multidiagnostic – Electrolytes Test – Product Status 205

Multidiagnostic – Electrolytes Test – Product Description 206

Multidiagnostic – Lactate Test – Product Status 206

Multidiagnostic – Lactate Test – Product Description 206

Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 207

Chemcare Test Strip – BET – Product Status 207

Chemcare Test Strip – BET – Product Description 208

Chemcare Test Strip – D-LAC – Product Status 208

Chemcare Test Strip – D-LAC – Product Description 208

Chemcare Test Strip – DAO – Product Status 209

Chemcare Test Strip – DAO – Product Description 209

Chemcare Test Strip – DBIL – Product Status 209

Chemcare Test Strip – DBIL – Product Description 210

Chemcare Test Strip – G6PD – Product Status 210

Chemcare Test Strip – G6PD – Product Description 210

Chemcare Test Strip – NH3 – Product Status 211

Chemcare Test Strip – NH3 – Product Description 211

Chemcare Test Strip – TBA – Product Status 211

Chemcare Test Strip – TBA – Product Description 212

Healthmed Services Ltd. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 213

Glycated Albumin Test – Product Status 213

Glycated Albumin Test – Product Description 213

Healthy io Ltd Pipeline Products & Ongoing Clinical Trials Overview 214

Home Based Dipstick Analyzer – Skincare – Product Status 214

Home Based Dipstick Analyzer – Skincare – Product Description 214

Minuteful 10 – Product Status 215

Minuteful 10 – Product Description 215

Horiba Ltd Pipeline Products & Ongoing Clinical Trials Overview 216

ABX Pentra 400 Analyzer – TDM Assay – Product Status 216

ABX Pentra 400 Analyzer – TDM Assay – Product Description 216

Pentra C200 Analyzer – TDM Assay – Product Status 217

Pentra C200 Analyzer – TDM Assay – Product Description 217

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 218

Diagnostic Test – Autism – Product Status 218

Diagnostic Test – Autism – Product Description 218

Lipase Enzymatic Assay – Product Status 219

Lipase Enzymatic Assay – Product Description 219

Protease Enzymatic Assay – Product Status 219

Protease Enzymatic Assay – Product Description 219

Transferase Enzymatic Assay – Product Status 220

Transferase Enzymatic Assay – Product Description 220

In Vitro Diagnostic Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 221

Dual Analyte Detection Test – Product Status 221

Dual Analyte Detection Test – Product Description 221

Renal Function Panel – Product Status 222

Renal Function Panel – Product Description 222

Indian Institute of Technology Delhi Pipeline Products & Ongoing Clinical Trials Overview 223

Opto-Electronic Sensor – Micro-Albumin – Product Status 223

Opto-Electronic Sensor – Micro-Albumin – Product Description 223

Inflammatix Inc Pipeline Products & Ongoing Clinical Trials Overview 224

HostDxTNFresponse – Product Status 224

HostDxTNFresponse – Product Description 224

Insilixa, Inc. Pipeline Products & Ongoing Clinical Trials Overview 225

POC DNA-based Diagnostic Test – Product Status 225

POC DNA-based Diagnostic Test – Product Description 225

Instrumentation Laboratory Co Pipeline Products & Ongoing Clinical Trials Overview 226

GEM Premier 4000 Analyzer – BUN – Product Status 226

GEM Premier 4000 Analyzer – BUN – Product Description 226

GEM Premier 4000 Analyzer – tCO2 Test – Product Status 227

GEM Premier 4000 Analyzer – tCO2 Test – Product Description 227

HemosIL Dabigatran Assay – Product Status 227

HemosIL Dabigatran Assay – Product Description 228

POC Enzymatic Creatinine Assay – Product Status 228

POC Enzymatic Creatinine Assay – Product Description 228

IPI Singapore Pipeline Products & Ongoing Clinical Trials Overview 229

Diagnostic Test – Pneumonia – Product Status 229

Diagnostic Test – Pneumonia – Product Description 229

IR2Dx Inc. Pipeline Products & Ongoing Clinical Trials Overview 230

Drug Response Panel – Product Status 230

Drug Response Panel – Product Description 230

IRIS International Inc Pipeline Products & Ongoing Clinical Trials Overview 231

3GEMS Next Generation Urinalysis Platform – Product Status 231

3GEMS Next Generation Urinalysis Platform – Product Description 231

iXensor Co. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 232

Uric Acid Test – Product Status 232

Uric Acid Test – Product Description 232

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 233

Predictive Test For Chemotherapy Regimen – Product Status 233

Predictive Test For Chemotherapy Regimen – Product Description 233

Kalium Health Ltd Pipeline Products & Ongoing Clinical Trials Overview 234

Blood Potassium Monitoring Test – Product Status 234

Blood Potassium Monitoring Test – Product Description 234

KIYATEC Inc Pipeline Products & Ongoing Clinical Trials Overview 235

Ex Vivo 3D Drug Response (EV3D) Assay – Product Status 235

Ex Vivo 3D Drug Response (EV3D) Assay – Product Description 235

KIYATEC Inc – Ongoing Clinical Trials Overview 236

Ex Vivo 3D Drug Response (EV3D) Assay – 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells from Tumors: 3D-PREDICT REGISTRY 237

Kobe University Pipeline Products & Ongoing Clinical Trials Overview 238

Diagnostic Kit – Bilirubin – Product Status 238

Diagnostic Kit – Bilirubin – Product Description 238

Kwandong University College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 239

Diagnostic Test – Foetal Gender – Product Status 239

Diagnostic Test – Foetal Gender – Product Description 239

L’epigeneMD Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 240

Molecular Diagnostic Test – Diabetic Retinopathy – Product Status 240

Molecular Diagnostic Test – Diabetic Retinopathy – Product Description 240

Laboratorios Rubio SA Pipeline Products & Ongoing Clinical Trials Overview 241

Liposcale – Product Status 241

Liposcale – Product Description 241

LifeAssays AB Pipeline Products & Ongoing Clinical Trials Overview 242

LifeAssays U-Albumin – Product Status 242

LifeAssays U-Albumin – Product Description 242

LumiraDx Ltd Pipeline Products & Ongoing Clinical Trials Overview 243

LumiraDx – Na, K – Product Status 243

LumiraDx – Na, K – Product Description 243

Magee-Womens Research Institute Pipeline Products & Ongoing Clinical Trials Overview 244

Point-Of-Care Test – HIV – Product Status 244

Point-Of-Care Test – HIV – Product Description 244

Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 245

Paper Test Strip – Blood Clots – Product Status 245

Paper Test Strip – Blood Clots – Product Description 245

Medical Research Council Pipeline Products & Ongoing Clinical Trials Overview 246

Diagnostic Assay – Hormone Dependent Tumours – Product Status 246

Diagnostic Assay – Hormone Dependent Tumours – Product Description 246

Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 247

Point-Of-Care Diagnostic Test – Cardiac Resynchronization Therapy – Product Status 247

Point-Of-Care Diagnostic Test – Cardiac Resynchronization Therapy – Product Description 247

Metabolon Inc Pipeline Products & Ongoing Clinical Trials Overview 248

Cisplatin Tolerance Test – Product Status 248

Cisplatin Tolerance Test – Product Description 248

Prostate Cancer TDM Test – Product Status 249

Prostate Cancer TDM Test – Product Description 249

Miami VA Healthcare System Pipeline Products & Ongoing Clinical Trials Overview 250

Disease-Associated Mineral Crystal Assay – Product Status 250

Disease-Associated Mineral Crystal Assay – Product Description 250

MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 251

Labchip Based Test – Glucose – Product Status 251

Labchip Based Test – Glucose – Product Description 251

Rapid Diagnostic Labchip Based Kit – Product Status 252

Rapid Diagnostic Labchip Based Kit – Product Description 252

Monash University Pipeline Products & Ongoing Clinical Trials Overview 253

Bilirubin Test – Product Status 253

Bilirubin Test – Product Description 253

Paper Test – Jaundice – Product Status 254

Paper Test – Jaundice – Product Description 254

Montana State University Pipeline Products & Ongoing Clinical Trials Overview 255

Whole Blood Cholinesterase Assay – Product Status 255

Whole Blood Cholinesterase Assay – Product Description 255

Mylab Discovery Solutions Pvt Ltd Pipeline Products & Ongoin

Figures

Clinical Chemistry – Pipeline Products by Stage of Development 38

Clinical Chemistry – Pipeline Products by Segment 39

Clinical Chemistry – Pipeline Products by Territory 41

Clinical Chemistry – Pipeline Products by Regulatory Path 43

Clinical Chemistry – Pipeline Products by Estimated Approval Date 44

Clinical Chemistry – Ongoing Clinical Trials 45

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