Immunochemistry Rapid Tests and POC Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

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Spot test kits intended generally for rapid diagnosis, with immediate results, through immuno assays. Some of the tests carried out using immunochemistry rapid test include rabies virus test, allergenic food proteins, and enteric infection.

The immunochemistry rapid tests and POC pipeline market research report provides comprehensive information about the immunochemistry rapid tests and POC pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Immunochemistry Rapid Tests and POC Pipeline Products Market Segments

The key segments in the immunochemistry rapid tests and POC pipeline products market are Other Immunochemistry Rapid Tests, Other Cardiac Markers Rapid Tests & POC, Cardiac Markers Rapid Tests & POC, Drugs of Abuse / Toxicology Rapid Tests, Troponin Rapid Tests & POC, Brain Natriuretic Peptide (BNP) Rapid Tests & POC, Human Chorionic Gonadotropin (hCG) Rapid Tests, Female Fertility Rapid Tests, and Follicle-Stimulating Hormone (FSH) Rapid Tests. Other Immunochemistry Rapid Tests have the highest number of products in the immunochemistry rapid tests and POC pipeline products market.

Immunochemistry Rapid Tests and POC Pipeline Products Market Analysis by Segments, 2022 (%)

Immunochemistry Rapid Tests and POC Pipeline Products Market Analysis by Segments

For more insights into the immunochemistry rapid tests and POC pipeline products market segments, download a free report sample

Immunochemistry Rapid Tests and POC Pipeline Products Market Segmentation by Territories

Some of the key territories with immunochemistry rapid tests and POC products in the pipeline are the United States, Europe, Global, South Korea, China, India, Russia, Canada, Australia, Israel, and the United Kingdom among others. As of November 2022, the US has the highest number of products in the pipeline out of them all.

Immunochemistry Rapid Tests and POC Pipeline Products Market Analysis, by Territories, 2022 (%)

Immunochemistry Rapid Tests and POC Pipeline Products Market Analysis, by TerritoriesFor more territory insights into the immunochemistry rapid tests and POC pipeline products market, download a free report sample

Immunochemistry Rapid Tests and POC Pipeline Products Market Segmentation by Regulatory Paths

Some of the key regulatory paths followed by the immunochemistry rapid tests and POC pipeline products market are 510(k), CE-IVD, MDITAC, NMPA, ICAC, MDL, TGA, PMA, BOPA, and UKCA among others. Most of the products follow the 510(k) pathway to enter the market.

Immunochemistry Rapid Tests and POC Pipeline Products Market Analysis, by Regulatory Paths, 2022 (%)

Immunochemistry Rapid Tests and POC Pipeline Products Market Analysis, by Regulatory PathsFor more immunochemistry rapid tests and POC pipeline products regulatory path insights, download a free report sample

Immunochemistry Rapid Tests and POC Pipeline Products Market - Competitive Landscape

Some of the leading companies in the immunochemistry rapid tests and POC pipeline products market are 1Drop Diagnostics, 4D Pharma PLC, 5M Biomed LLC, Abbott Diagnostics, Abbott Point of Care Inc, Abionic SA, Abwiz Bio Inc, Accel Diagnostics LLC, Access Bio Inc, and Accord Biomaterials, Inc. (Inactive) among others.

Immunochemistry Rapid Tests and POC Pipeline Products Market Report Overview

Key Segments Other Immunochemistry Rapid Tests, Other Cardiac Markers Rapid Tests & POC, Cardiac Markers Rapid Tests & POC, Drugs of Abuse / Toxicology Rapid Tests, Troponin Rapid Tests & POC, Brain Natriuretic Peptide (BNP) Rapid Tests & POC, Human Chorionic Gonadotropin (hCG) Rapid Tests, Female Fertility Rapid Tests, and Follicle-Stimulating Hormone (FSH) Rapid Tests
Analysis Year 2022
Key Territories The United States, Europe, Global, South Korea, China, India, Russia, Canada, Australia, Israel, and the United Kingdom
Key Regulatory Paths 510(k), CE-IVD, MDITAC, NMPA, ICAC, MDL, TGA, PMA, BOPA, and UKCA
Leading Companies 1Drop Diagnostics, 4D Pharma PLC, 5M Biomed LLC, Abbott Diagnostics, Abbott Point of Care Inc, Abionic SA, Abwiz Bio Inc, Accel Diagnostics LLC, Access Bio Inc, and Accord Biomaterials, Inc. (Inactive)

Immunochemistry Rapid Tests and POC Pipeline Products Market Segments Outlook (2022)

  • Other Immunochemistry Rapid Tests
  • Other Cardiac Markers Rapid Tests & POC
  • Cardiac Markers Rapid Tests & POC
  • Drugs of Abuse / Toxicology Rapid Tests
  • Troponin Rapid Tests & POC
  • Brain Natriuretic Peptide (BNP) Rapid Tests & POC
  • Human Chorionic Gonadotropin (hCG) Rapid Tests
  • Female Fertility Rapid Tests
  • Follicle-Stimulating Hormone (FSH) Rapid Tests

Immunochemistry Rapid Tests and POC Pipeline Products Market Territories Outlook (2022)

  • The United States
  • Europe
  • Global
  • South Korea
  • China
  • India
  • Russia
  • Canada
  • Australia
  • Israel
  • United Kingdom

Immunochemistry Rapid Tests and POC Pipeline Products Market Regulatory Paths Outlook (2022)

  • 510(k)
  • CE-IVD
  • MDITAC
  • NMPA
  • ICAC
  • MDL
  • TGA
  • PMA
  • BOPA
  • UKCA

Scope

This report provides:

  • Extensive coverage of the immunochemistry rapid tests and POC under development.
  • Details of major immunochemistry rapid tests and POC pipeline products which include product description, licensing, collaboration details, and other developmental activities including pipeline territories, regulatory paths, and estimated approval dates.
  • Reviews of the major players involved in the development of immunochemistry rapid tests and POC and list all their pipeline projects.
  • The coverage of immunochemistry rapid tests and POC pipeline products based on various stages of development ranging from early development to the approved/issued stage.
  • Key clinical trial data of ongoing trials specific to immunochemistry rapid tests and POC 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 a potentially strong product portfolio and create effective counterstrategies to gain a competitive advantage.
  • Identify and understand important and diverse types of immunochemistry rapid tests and POC 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.

1Drop Diagnostics
4D Pharma PLC
5M Biomed LLC
Abbott Diagnostics
Abbott Point of Care Inc
Abionic SA
Abwiz Bio Inc
Accel Diagnostics LLC
Access Bio Inc
Accord Biomaterials, Inc. (Inactive)
Affinergy LLC
Affinimark Technologies, Inc.
AgPlus Diagnostics LTD
Akrivis Technologies LLC
Alaunus Biosciences Inc
Alere Inc
Alfa Wassermann Inc
Am Biotechnologies, LLC
Ambergen Inc
American Bio Medica Corp
Amity University
Andraka Technologies, LLC
Angle Biosciences Inc
Anteo Technologies Pty Ltd
Antisoma Therapeutics Pty Ltd
Astute Medical Inc
Atomo Diagnostics Ltd
Atonomics A/S (Inactive)
Attogene Corp
Attophotonics Biosciences GmbH
Augurix SA
Aurelium BioPharma Inc.
Axim Biotechnologies Inc
Axis-Shield Diagnostics Ltd
Axiva Sichem Biotech
Baylor Scott & White Research Institute
BBB Technologies Inc
Becton Dickinson and Co
Ben-Gurion University of the Negev
Berlin Institute for Health
Bio-AMD Inc
BioCurex Inc
Biodesix Inc
Biogenes Technologies Sdn Bhd
BioMark Diagnostics Inc
Bio-Me AS
BioMedomics Inc
Biomerica Inc
bioMerieux SA
Bioo Scientific Corp
Biopeptides Corp
Biopico Systems Inc
BiOracle Ltd (Inactive)
Biosensia Ltd
Biosensorix Pte Ltd
Biostealth, Inc.
Biosurfit, SA
BioTron Diagnostics Inc.
Bluejay Diagnostics Inc
Boditech Med Inc
Boston Children's Hospital
Brainbox Solutions Inc
Carclo Diagnostic Solutions Ltd
CardioGenics Inc
Cascade Metrix LLC
Cellex Inc
Chembio Diagnostic Systems Inc
Children's Hospital of Philadelphia
Cincinnati Children's Hospital Medical Center
Claro Scientific LLC (Inactive)
Co-Diagnostics Inc
Cognizance Biomarkers LLC
Contango Asset Management Ltd
Coris BioConcept
Correlia Biosystems, Inc.
CTK Biotech Inc
Curetis GmbH
Cx Precision Medicine Inc
Daktari Diagnostics, Inc.
Dartmouth College
DiabetOmics Inc
Diafir
DiagNodus Ltd
DiagnosTear Ltd.
Diagnostics For All Inc
Dianax S.R.L
DiaSys Diagnostic Systems GmbH
Diazyme Laboratories Inc
Dimerix Ltd
DioTeX Diagnostics
DRD Biotech Ltd
Duke University
Dynasil Corporation of America
Eachy Biopharmaceuticals Ltd
Eclipse Diagnostics Inc
Edan Instruments Inc
Edan Medical
EKF Diagnostics Holdings Plc
Endeavor Sciences Inc
Enesi Pharma Ltd
Epinex Diagnostics Inc
Erasmus University Rotterdam
ET Healthcare Inc
Ethonova Inc
FibroTx LLC
Foundation for Innovative New Diagnostics
Fraunhofer-Gesellschaft zur Forderung der Angewandten Forschung eV
GAIA Medical Institute LLC
Gendiag
genedrive plc
General Biologicals Corp
Genesis Detection Systems, Inc.
Genrui Biotech Inc
Genspeed Biotech Gmbh
Georgetown University
Georgia State University
GestVision Inc
Ghent University
Group K Diagnostics
Guangzhou Wondfo Biotech Co Ltd
Halcyon Biomedical Inc
Hansjorg Wyss Institute for Biologically Inspired Engineering
HealthTell Inc
Hemex Health Inc
I-calQ LLC
IDL Biotech AB
Immuno Technologies Inc
ImmunoScience Inc
Immunovent LLC
Immunovia AB
Imperial College London
INEX Innovate Pte Ltd
Inflammatix Inc
Inform Bioscience Ltd
Innogenomics Technologies LLC
Instadiagnostics Inc
Instanosis Inc
Institute of Cancer Research
Intelligent Optical Systems, Inc.
IntraMed Diagnostics, LLC
Iowa State University
IR Diagnostyx Inc.
IR2Dx Inc.
IRCCS San Raffaele Hospital
Ischemia Care LLC
Jana Care Inc
Kenota Inc
King Abdullah University of Science and Technology
KSK Diagnostics GmbH
Laboratory Corp of America Holdings
Leading BioSciences Inc
Lenima Field Diagnostics LLC
LeukoDx Ltd
LifeAssay Diagnostics (Pty) Ltd
LightDeck Diagnostics Inc
Ludwig-Maximilians-University Munich
Lumabs BV
LumiraDx Ltd
Lumos Diagnostics Holdings Ltd
Luna Innovations Inc
Lung Biotechnology PBC
Lynntech Inc
Lynx Biosciences LLC
MagneSensors, Inc.
Massachusetts General Hospital
Maxim Biomedical Inc
Mayo Clinic
McMaster University
Medical University of South Carolina
Medicortex Finland Oy
Mediomics, LLC
Mellitus LLC
MeMed Diagnostics LTD
MiCo BioMed Co Ltd
MML Ltd
Mobidiag Ltd
Molbio Diagnostics Pvt Ltd
Molecular Stethoscope Inc
Mologic Ltd
MOMM Diagnostics
Monash University
MoyoMedical Technologies
Mylab Discovery Solutions Pvt Ltd
MyMD Pharmaceuticals Inc
Nalia Systems Ltd
NanoDx Inc
Nanomix Inc
NanoRepro AG
NanoScale Corp
Nanyang Technological University
National University of Ireland Galway
Neolys Diagnostics
Nephrogen LLC
NG Biotech
Nirmidas Biotech Inc
Nortis, Inc.
Novartis AG
NOWDiagnostics Inc
NTBIO Diagnostics Inc
Oasis Diagnostics Corp
Ohio State University
Ohio State University Wexner Medical Center
Ohmx Corp
OJ-Bio Ltd (Inactive)
OncoGenesis Corp
OPKO Health Inc
OSLER Diagnostics Ltd
OvaGene Oncology Inc
Ovation Diagnostics LLC
Pacific Edge Ltd
Pasteur Institute
Pennsylvania State University
Philips Healthcare
Philips Healthcare Nederland BV
Phoenix Biosystems Inc
PixCell Medical Technologies Ltd
Polytechnic University of Valencia
Princeton University
ProAxsis Ltd
ProciseDx LLC
ProMIS Neurosciences Inc
Proxim Diagnostics Corp
Purdue University
QLIDA Diagnostics
Qorvo Biotechnologies LLC
Qualizyme Diagnostics GmbH & Co KG
QuantuMDx Group Ltd
Quick, LLC
Quidel Corp
Radiometer Medical ApS
Radisens Diagnostics Ltd
Renishaw Plc
Resdin Technologies Inc.
Roche Diagnostics International Ltd
Rockefeller University
Royal College of Surgeons Ireland
Salignostics Ltd
Sandia National Laboratories
Sapphire Biotech Inc
Sarissa-Biomedical Ltd
Seacoast Science, Inc.
SensDx SA
Sensei Biotherapeutics Inc
Sentilus LLC
SFC Fluidics LLC
Shineco Inc
Siloam Biosciences, Inc.
Sime Diagnostics Ltd
SkylineDx BV
Sona Nanotech Inc
SpinChip Diagnostics AS
SQI Diagnostics Inc
Sri Ramachandra Institute of Higher Education and Research
SynderBio Inc
Syntron Bioresearch Inc
Telovision, LLC
The Chinese University of Hong Kong
The Forsyth Institute
The University of Manchester
Theodor Bilharz Research Institute
Thermo Fisher Scientific Inc
ThreeFold Sensors (Inactive)
Todos Medical
Trinity Biotech Plc
Tritek Innovation Pvt Ltd
Trivitron Healthcare Pvt Ltd
True Diagnostics Inc
University of Adelaide
University of Amsterdam
University of Basel
University of Bath
University of California Los Angeles
University of California San Diego
University of California Santa Barbara
University of Chicago
University of Colorado
University of Delhi
University of Edinburgh
University of Glasgow
University of Helsinki
University of Houston
University of Oxford
University of Pennsylvania
University of Pittsburgh
University of South Australia
University of South Florida
University of Turku
University of Utah
University of Vermont
University of Western Australia
University of Wisconsin Madison
University Rovira i Virgili
Upstream Medical Technologies Ltd
Valtari Bio Inc
Vanderbilt University
Verum Diagnostics Inc
Vidcare Innovations Pvt Ltd
Virginia Commonwealth University
Vitan-Biotech LLC
VolitionRX Ltd
Vybion Inc
Washington University in St Louis
Wave 80 Biosciences Inc
West Virginia University
Xcellence in Bio Innovations & Technologies Pvt Ltd
Yale University
ZEUS Scientific Inc
ZRT Laboratory LLC

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 16

|1.2 List of Figures 45

2 Introduction 46

2.1 Immunochemistry Rapid Tests & POC Overview 46

3 Products under Development 47

3.1 Immunochemistry Rapid Tests & POC – Pipeline Products by Stage of Development 47

3.2 Immunochemistry Rapid Tests & POC – Pipeline Products by Segment 48

3.3 Immunochemistry Rapid Tests & POC – Pipeline Products by Territory 49

3.4 Immunochemistry Rapid Tests & POC – Pipeline Products by Regulatory Path 51

3.5 Immunochemistry Rapid Tests & POC – Pipeline Products by Estimated Approval Date 52

3.6 Immunochemistry Rapid Tests & POC – Ongoing Clinical Trials 53

4 Immunochemistry Rapid Tests & POC – Pipeline Products under Development by Companies 54

4.1 Immunochemistry Rapid Tests & POC Companies – Pipeline Products by Stage of Development 54

4.2 Immunochemistry Rapid Tests & POC – Pipeline Products by Stage of Development 66

5 Immunochemistry Rapid Tests & POC Companies and Product Overview 81

5.1 1Drop Diagnostics Company Overview 81

5.1.1 1Drop Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 81

5.2 4D Pharma PLC Company Overview 84

5.2.1 4D Pharma PLC Pipeline Products & Ongoing Clinical Trials Overview 84

5.3 5M Biomed LLC Company Overview 85

5.3.1 5M Biomed LLC Pipeline Products & Ongoing Clinical Trials Overview 85

5.4 Abbott Diagnostics Company Overview 86

5.4.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 86

5.5 Abbott Point of Care Inc Company Overview 87

5.5.1 Abbott Point of Care Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.6 Abionic SA Company Overview 89

5.6.1 Abionic SA Pipeline Products & Ongoing Clinical Trials Overview 89

5.7 Abwiz Bio Inc Company Overview 93

5.7.1 Abwiz Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.8 Accel Diagnostics LLC Company Overview 94

5.8.1 Accel Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 94

5.9 Access Bio Inc Company Overview 96

5.9.1 Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.10 Accord Biomaterials, Inc. (Inactive) Company Overview 97

5.10.1 Accord Biomaterials, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 97

5.11 Affinergy LLC Company Overview 98

5.11.1 Affinergy LLC Pipeline Products & Ongoing Clinical Trials Overview 98

5.12 Affinimark Technologies, Inc. Company Overview 101

5.12.1 Affinimark Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 101

5.13 AgPlus Diagnostics LTD Company Overview 102

5.13.1 AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 102

5.14 Akrivis Technologies LLC Company Overview 104

5.14.1 Akrivis Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 104

5.15 Alaunus Biosciences Inc Company Overview 105

5.15.1 Alaunus Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.16 Alere Inc Company Overview 106

5.16.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 106

5.17 Alfa Wassermann Inc Company Overview 108

5.17.1 Alfa Wassermann Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.18 Am Biotechnologies, LLC Company Overview 110

5.18.1 Am Biotechnologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 110

5.19 Ambergen Inc Company Overview 113

5.19.1 Ambergen Inc Pipeline Products & Ongoing Clinical Trials Overview 113

5.20 American Bio Medica Corp Company Overview 114

5.20.1 American Bio Medica Corp Pipeline Products & Ongoing Clinical Trials Overview 114

5.21 Amity University Company Overview 117

5.21.1 Amity University Pipeline Products & Ongoing Clinical Trials Overview 117

5.22 Andraka Technologies, LLC Company Overview 118

5.22.1 Andraka Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 118

5.23 Angle Biosciences Inc Company Overview 119

5.23.1 Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 119

5.24 Anteo Technologies Pty Ltd Company Overview 121

5.24.1 Anteo Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 121

5.25 Antisoma Therapeutics Pty Ltd Company Overview 123

5.25.1 Antisoma Therapeutics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 123

5.26 Astute Medical Inc Company Overview 124

5.26.1 Astute Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 124

5.27 Atomo Diagnostics Ltd Company Overview 125

5.27.1 Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 125

5.28 Atonomics A/S (Inactive) Company Overview 127

5.28.1 Atonomics A/S (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 127

5.29 Attogene Corp Company Overview 137

5.29.1 Attogene Corp Pipeline Products & Ongoing Clinical Trials Overview 137

5.30 Attophotonics Biosciences GmbH Company Overview 138

5.30.1 Attophotonics Biosciences GmbH Pipeline Products & Ongoing Clinical Trials Overview 138

5.31 Augurix SA Company Overview 139

5.31.1 Augurix SA Pipeline Products & Ongoing Clinical Trials Overview 139

5.32 Aurelium BioPharma Inc. Company Overview 140

5.32.1 Aurelium BioPharma Inc. Pipeline Products & Ongoing Clinical Trials Overview 140

5.33 Axim Biotechnologies Inc Company Overview 141

5.33.1 Axim Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 141

5.34 Axis-Shield Diagnostics Ltd Company Overview 143

5.34.1 Axis-Shield Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

5.35 Axiva Sichem Biotech Company Overview 144

5.35.1 Axiva Sichem Biotech Pipeline Products & Ongoing Clinical Trials Overview 144

5.36 Baylor Scott & White Research Institute Company Overview 145

5.36.1 Baylor Scott & White Research Institute Pipeline Products & Ongoing Clinical Trials Overview 145

5.37 BBB Technologies Inc Company Overview 146

5.37.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 146

5.38 Becton Dickinson and Co Company Overview 159

5.38.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 159

5.39 Ben-Gurion University of the Negev Company Overview 160

5.39.1 Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 160

5.40 Berlin Institute for Health Company Overview 162

5.40.1 Berlin Institute for Health Pipeline Products & Ongoing Clinical Trials Overview 162

5.41 Bio-AMD Inc Company Overview 163

5.41.1 Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.42 BioCurex Inc Company Overview 168

5.42.1 BioCurex Inc Pipeline Products & Ongoing Clinical Trials Overview 168

5.43 Biodesix Inc Company Overview 169

5.43.1 Biodesix Inc Pipeline Products & Ongoing Clinical Trials Overview 169

5.44 Biogenes Technologies Sdn Bhd Company Overview 172

5.44.1 Biogenes Technologies Sdn Bhd Pipeline Products & Ongoing Clinical Trials Overview 172

5.45 BioMark Diagnostics Inc Company Overview 173

5.45.1 BioMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 173

5.46 Bio-Me AS Company Overview 174

5.46.1 Bio-Me AS Pipeline Products & Ongoing Clinical Trials Overview 174

5.47 BioMedomics Inc Company Overview 175

5.47.1 BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 175

5.48 Biomerica Inc Company Overview 181

5.48.1 Biomerica Inc Pipeline Products & Ongoing Clinical Trials Overview 181

5.49 bioMerieux SA Company Overview 185

5.49.1 bioMerieux SA Pipeline Products & Ongoing Clinical Trials Overview 185

5.50 Bioo Scientific Corp Company Overview 186

5.50.1 Bioo Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 186

5.51 Biopeptides Corp Company Overview 187

5.51.1 Biopeptides Corp Pipeline Products & Ongoing Clinical Trials Overview 187

5.52 Biopico Systems Inc Company Overview 188

5.52.1 Biopico Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 188

5.53 BiOracle Ltd (Inactive) Company Overview 189

5.53.1 BiOracle Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 189

5.54 Biosensia Ltd Company Overview 191

5.54.1 Biosensia Ltd Pipeline Products & Ongoing Clinical Trials Overview 191

5.55 Biosensorix Pte Ltd Company Overview 194

5.55.1 Biosensorix Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 194

5.56 Biostealth, Inc. Company Overview 195

5.56.1 Biostealth, Inc. Pipeline Products & Ongoing Clinical Trials Overview 195

5.57 Biosurfit, SA Company Overview 196

5.57.1 Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 196

5.58 BioTron Diagnostics Inc. Company Overview 197

5.58.1 BioTron Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 197

5.59 Bluejay Diagnostics Inc Company Overview 198

5.59.1 Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 198

5.60 Boditech Med Inc Company Overview 202

5.60.1 Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 202

5.61 Boston Children’s Hospital Company Overview 218

5.61.1 Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 218

5.62 Brainbox Solutions Inc Company Overview 220

5.62.1 Brainbox Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 220

5.63 Carclo Diagnostic Solutions Ltd Company Overview 225

5.63.1 Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 225

5.64 CardioGenics Inc Company Overview 227

5.64.1 CardioGenics Inc Pipeline Products & Ongoing Clinical Trials Overview 227

5.65 Cascade Metrix LLC Company Overview 230

5.65.1 Cascade Metrix LLC Pipeline Products & Ongoing Clinical Trials Overview 230

5.66 Cellex Inc Company Overview 231

5.66.1 Cellex Inc Pipeline Products & Ongoing Clinical Trials Overview 231

5.67 Chembio Diagnostic Systems Inc Company Overview 232

5.67.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 232

5.68 Children’s Hospital of Philadelphia Company Overview 235

5.68.1 Children’s Hospital of Philadelphia Pipeline Products & Ongoing Clinical Trials Overview 235

5.69 Cincinnati Children’s Hospital Medical Center Company Overview 237

5.69.1 Cincinnati Children’s Hospital Medical Center Pipeline Products & Ongoing Clinical Trials Overview 237

5.70 Claro Scientific LLC (Inactive) Company Overview 238

5.70.1 Claro Scientific LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 238

5.71 Co-Diagnostics Inc Company Overview 239

5.71.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 239

5.72 Cognizance Biomarkers LLC Company Overview 240

5.72.1 Cognizance Biomarkers LLC Pipeline Products & Ongoing Clinical Trials Overview 240

5.73 Contango Asset Management Ltd Company Overview 243

5.73.1 Contango Asset Management Ltd Pipeline Products & Ongoing Clinical Trials Overview 243

5.74 Coris BioConcept Company Overview 244

5.74.1 Coris BioConcept Pipeline Products & Ongoing Clinical Trials Overview 244

5.75 Correlia Biosystems, Inc. Company Overview 245

5.75.1 Correlia Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 245

5.76 CTK Biotech Inc Company Overview 246

5.76.1 CTK Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 246

5.77 Curetis GmbH Company Overview 247

5.77.1 Curetis GmbH Pipeline Products & Ongoing Clinical Trials Overview 247

5.78 Cx Precision Medicine Inc Company Overview 248

5.78.1 Cx Precision Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 248

5.79 Daktari Diagnostics, Inc. Company Overview 250

5.79.1 Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 250

5.80 Dartmouth College Company Overview 251

5.80.1 Dartmouth College Pipeline Products & Ongoing Clinical Trials Overview 251

5.81 DiabetOmics Inc Company Overview 254

5.81.1 DiabetOmics Inc Pipeline Products & Ongoing Clinical Trials Overview 254

5.82 Diafir Company Overview 256

5.82.1 Diafir Pipeline Products & Ongoing Clinical Trials Overview 256

5.83 DiagNodus Ltd Company Overview 258

5.83.1 DiagNodus Ltd Pipeline Products & Ongoing Clinical Trials Overview 258

5.84 DiagnosTear Ltd. Company Overview 259

5.84.1 DiagnosTear Ltd. Pipeline Products & Ongoing Clinical Trials Overview 259

5.85 Diagnostics For All Inc Company Overview 262

5.85.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 262

5.86 Dianax S.R.L Company Overview 265

5.86.1 Dianax S.R.L Pipeline Products & Ongoing Clinical Trials Overview 265

5.87 DiaSys Diagnostic Systems GmbH Company Overview 268

5.87.1 DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 268

5.88 Diazyme Laboratories Inc Company Overview 269

5.88.1 Diazyme Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 269

5.89 Dimerix Ltd Company Overview 270

5.89.1 Dimerix Ltd Pipeline Products & Ongoing Clinical Trials Overview 270

5.90 DioTeX Diagnostics Company Overview 271

5.90.1 DioTeX Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 271

5.91 DRD Biotech Ltd Company Overview 272

5.91.1 DRD Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 272

5.92 Duke University Company Overview 275

5.92.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 275

5.93 Dynasil Corporation of America Company Overview 276

5.93.1 Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview 276

5.94 Eachy Biopharmaceuticals Ltd Company Overview 278

5.94.1 Eachy Biopharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 278

5.95 Eclipse Diagnostics Inc Company Overview 281

5.95.1 Eclipse Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 281

5.96 Edan Instruments Inc Company Overview 282

5.96.1 Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 282

5.97 Edan Medical Company Overview 287

5.97.1 Edan Medical Pipeline Products & Ongoing Clinical Trials Overview 287

5.98 EKF Diagnostics Holdings Plc Company Overview 299

5.98.1 EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 299

5.99 Endeavor Sciences Inc Company Overview 300

5.99.1 Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 300

5.100 Enesi Pharma Ltd Company Overview 301

5.100.1 Enesi Pharma Ltd Pipeline Products & Ongoing Clinical Trials Overview 301

5.101 Epinex Diagnostics Inc Company Overview 302

5.101.1 Epinex Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 302

5.102 Erasmus University Rotterdam Company Overview 305

5.102.1 Erasmus University Rotterdam Pipeline Products & Ongoing Clinical Trials Overview 305

5.103 ET Healthcare Inc Company Overview 306

5.103.1 ET Healthcare Inc Pipeline Products & Ongoing Clinical Trials Overview 306

5.104 Ethonova Inc Company Overview 309

5.104.1 Ethonova Inc Pipeline Products & Ongoing Clinical Trials Overview 309

5.105 FibroTx LLC Company Overview 310

5.105.1 FibroTx LLC Pipeline Products & Ongoing Clinical Trials Overview 310

5.106 Foundation for Innovative New Diagnostics Company Overview 311

5.106.1 Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 311

5.107 Fraunhofer-Gesellschaft zur Forderung der Angewandten Forschung eV Company Overview 312

5.107.1 Fraunhofer-Gesellschaft zur Forderung der Angewandten Forschung eV Pipeline Products & Ongoing Clinical Trials Overview 312

5.108 GAIA Medical Institute LLC Company Overview 313

5.108.1 GAIA Medical Institute LLC Pipeline Products & Ongoing Clinical Trials Overview 313

5.109 Gendiag Company Overview 316

5.109.1 Gendiag Pipeline Products & Ongoing Clinical Trials Overview 316

5.110 genedrive plc Company Overview 317

5.110.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 317

5.111 General Biologicals Corp Company Overview 318

5.111.1 General Biologicals Corp Pipeline Products & Ongoing Clinical Trials Overview 318

5.112 Genesis Detection Systems, Inc. Company Overview 319

5.112.1 Genesis Detection Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 319

5.113 Genrui Biotech Inc Company Overview 320

5.113.1 Genrui Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 320

5.114 Genspeed Biotech Gmbh Company Overview 321

5.114.1 Genspeed Biotech Gmbh Pipeline Products & Ongoing Clinical Trials Overview 321

5.115 Georgetown University Company Overview 322

5.115.1 Georgetown University Pipeline Products & Ongoing Clinical Trials Overview 322

5.116 Georgia State University Company Overview 324

5.116.1 Georgia State University Pipeline Products & Ongoing Clinical Trials Overview 324

5.117 GestVision Inc Company Overview 325

5.117.1 GestVision Inc Pipeline Products & Ongoing Clinical Trials Overview 325

5.118 Ghent University Company Overview 326

5.118.1 Ghent University Pipeline Products & Ongoing Clinical Trials Overview 326

5.119 Group K Diagnostics Company Overview 328

5.119.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 328

5.120 Guangzhou Wondfo Biotech Co Ltd Company Overview 345

5.120.1 Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 345

5.121 Halcyon Biomedical Inc Company Overview 349

5.121.1 Halcyon Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 349

5.122 Hansjorg Wyss Institute for Biologically Inspired Engineering Company Overview 350

5.122.1 Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 350

5.123 HealthTell Inc Company Overview 351

5.123.1 HealthTell Inc Pipeline Products & Ongoing Clinical Trials Overview 351

5.124 Hemex Health Inc Company Overview 352

5.124.1 Hemex Health Inc Pipeline Products & Ongoing Clinical Trials Overview 352

5.125 I-calQ LLC Company Overview 353

5.125.1 I-calQ LLC Pipeline Products & Ongoing Clinical Trials Overview 353

5.126 IDL Biotech AB Company Overview 355

5.126.1 IDL Biotech AB Pipeline Products & Ongoing Clinical Trials Overview 355

5.127 Immuno Technologies Inc Company Overview 356

5.127.1 Immuno Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 356

5.128 ImmunoScience Inc Company Overview 357

5.128.1 ImmunoScience Inc Pipeline Products & Ongoing Clinical Trials Overview 357

5.129 Immunovent LLC Company Overview 358

5.129.1 Immunovent LLC Pipeline Products & Ongoing Clinical Trials Overview 358

5.130 Immunovia AB Company Overview 359

5.130.1 Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview 359

5.131 Imperial College London Company Overview 362

5.131.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 362

5.132 INEX Innovate Pte Ltd Company Overview 364

5.132.1 INEX Innovate Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 364

5.133 Inflammatix Inc Company Overview 365

5.133.1 Inflammatix Inc Pipeline Products & Ongoing Clinical Trials Overview 365

5.134 Inform Bioscience Ltd Company Overview 366

5.134.1 Inform Bioscience Ltd Pipeline Products & Ongoing Clinical Trials Overview 366

5.135 Innogenomics Technologies LLC Company Overview 367

5.135.1 Innogenomics Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 367

5.136 Instadiagnostics Inc Company Overview 368

5.136.1 Instadiagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 368

5.137 Instanosis Inc Company Overview 370

5.137.1 Instanosis Inc Pipeline Products & Ongoing Clinical Trials Overview 370

5.138 Institute of Cancer Research Company Overview 371

5.138.1 Institute of Cancer Research Pipeline Products & Ongoing Clinical Trials Overview 371

5.139 Intelligent Optical Systems, Inc. Company Overview 372

5.139.1 Intelligent Optical Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 372

5.140 IntraMed Diagnostics, LLC Company Overview 373

5.140.1 IntraMed Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 373

5.141 Iowa State University Company Overview 374

5.141.1 Iowa State University Pipeline Products & Ongoing Clinical Trials Overview 374

5.142 IR Diagnostyx Inc. Company Overview 375

5.142.1 IR Diagnostyx Inc. Pipeline Products & Ongoing Clinical Trials Overview 375

5.143 IR2Dx Inc. Company Overview 378

5.143.1 IR2Dx Inc. Pipeline Products & Ongoing Clinical Trials Overview 378

5.144 IRCCS San Raffaele Hospital Company Overview 379

5.144.1 IRCCS San Raffaele Hospital Pipeline Products & Ongoing Clinical Trials Overview 379

5.145 Ischemia Care LLC Company Overview 380

5.145.1 Ischemia Care LLC Pipeline Products & Ongoing Clinical Trials Overview 380

5.146 Jana Care Inc Company Overview 381

5.146.1 Jana Care Inc Pipeline Products & Ongoing Clinical Trials Overview 381

5.147 Kenota Inc Company Overview 382

5.147.1 Kenota Inc Pipeline Products & Ongoing Clinical Trials Overview 382

5.148 King Abdullah University of Science and Technology Company Overview 383

5.148.1 King Abdullah University of Science and Technology Pipeline Products & Ongoing Clinical Trials Overview 383

5.149 KSK Diagnostics GmbH Company Overview 386

5.149.1 KSK Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 386

5.150 Laboratory Corp of America Holdings Company Overview 387

5.150.1 Laboratory Corp of America Holdings Pipeline Products & Ongoing Clinical Trials Overview 387

5.151 Leading BioSciences Inc Company Overview 388

5.151.1 Leading BioSciences Inc Pipeline Products & Ongoing Clinical Trials Overview 388

5.152 Lenima Field Diagnostics LLC Company Overview 389

5.152.1 Lenima Field Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 389

5.153 LeukoDx Ltd Company Overview 392

5.153.1 LeukoDx Ltd Pipeline Products & Ongoing Clinical Trials Overview 392

5.154 LifeAssay Diagnostics (Pty) Ltd Company Overview 395

5.154.1 LifeAssay Diagnostics (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 395

5.155 LightDeck Diagnostics Inc Company Overview 396

5.155.1 LightDeck Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 396

5.156 Ludwig-Maximilians-University Munich Company Overview 397

5.156.1 Ludwig-Maximilians-University Munich Pipeline Products & Ongoing Clinical Trials Overview 397

5.157 Lumabs BV Company Overview 398

5.157.1 Lumabs BV Pipeline Products & Ongoing Clinical Trials Overview 398

5.158 LumiraDx Ltd Company Overview 399

5.158.1 LumiraDx Ltd Pipeline Products & Ongoing Clinical Trials Overview 399

5.159 Lumos Diagnostics Holdings Ltd Company Overview 402

5.159.1 Lumos Diagnostics Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 402

5.160 Luna Innovations Inc Company Overview 403

5.160.1 Luna Innovations Inc Pipeline Products & Ongoing Clinical Trials Overview 403

5.161 Lung Biotechnology PBC Company Overview 404

5.161.1 Lung Biotechnology PBC Pipeline Products & Ongoing Clinical Trials Overview 404

5.162 Lynntech Inc Company Overview 405

5.162.1 Lynntech Inc Pipeline Products & Ongoing Clinical Trials Overview 405

5.163 Lynx Biosciences LLC Company Overview 406

5.163.1 Lynx Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 406

5.164 MagneSensors, Inc. Company Overview 407

5.164.1 MagneSensors, Inc. Pipeline Products & Ongoing Clinical Trials Overview 407

5.165 Massachusetts General Hospital Company Overview 408

5.165.1 Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 408

5.166 Maxim Biomedical Inc Company Overview 409

5.166.1 Maxim Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 409

5.167 Mayo Clinic Company Overview 410

5.167.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 410

5.168 McMaster University Company Overview 411

5.168.1 McMaster University Pipeline Products & Ongoing Clinical Trials Overview 411

5.169 Medical University of South Carolina Company Overview 412

5.169.1 Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 412

5.170 Medicortex Finland Oy Company Overview 416

5.170.1 Medicortex Finland Oy Pipeline Products & Ongoing Clinical Trials Overview 416

5.171 Mediomics, LLC Company Overview 417

5.171.1 Mediomics, LLC Pipeline Products & Ongoing Clinical Trials Overview 417

5.172 Mellitus LLC Company Overview 418

5.172.1 Mellitus LLC Pipeline Products & Ongoing Clinical Trials Overview 418

5.173 MeMed Diagnostics LTD Company Overview 419

5.173.1 MeMed Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 419

5.174 MiCo BioMed Co Ltd Company Overview 420

5.174.1 MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 420

5.175 MML Ltd Company Overview 421

5.175.1 MML Ltd Pipeline Products & Ongoing Clinical Trials Overview 421

5.176 Mobidiag Ltd Company Overview 422

5.176.1 Mobidiag Ltd Pipeline Products & Ongoing Clinical Trials Overview 422

5.177 Molbio Diagnostics Pvt Ltd Company Overview 424

5.177.1 Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 424

5.178 Molecular Stethoscope Inc Company Overview 427

5.178.1 Molecular Stethoscope Inc Pipeline Products & Ongoing Clinical Trials Overview 427

5.179 Mologic Ltd Company Overview 429

5.179.1 Mologic Ltd Pipeline Products & Ongoing Clinical Trials Overview 429

5.180 MOMM Diagnostics Company Overview 432

5.180.1 MOMM Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 432

5.181 Monash University Company Overview 433

5.181.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 433

5.182 MoyoMedical Technologies Company Overview 435

5.182.1 MoyoMedical Technologies Pipeline Products & Ongoing Clinical Trials Overview 435

5.183 Mylab Discovery Solutions Pvt Ltd Company Overview 436

5.183.1 Mylab Discovery Solutions Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 436

5.184 MyMD Pharmaceuticals Inc Company Overview 439

5.184.1 MyMD Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 439

5.185 Nalia Systems Ltd Company Overview 440

5.185.1 Nalia Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 440

5.186 NanoDx Inc Company Overview 443

5.186.1 NanoDx Inc Pipeline Products & Ongoing Clinical Trials Overview 443

5.187 Nanomix Inc Company Overview 445

5.187.1 Nanomix Inc Pipeline Products & Ongoing Clinical Trials Overview 445

5.188 NanoRepro AG Company Overview 449

5.188.1 NanoRepro AG Pipeline Products & Ongoing Clinical Trials Overview 449

5.189 NanoScale Corp Company Overview 454

5.189.1 NanoScale Corp Pipeline Products & Ongoing Clinical Trials Overview 454

5.190 Nanyang Technological University Company Overview 455

5.190.1 Nanyang Technological University Pipeline Products & Ongoing Clinical Trials Overview 455

5.191 National University of Ireland Galway Company Overview 456

5.191.1 National University of Ireland Galway Pipeline Products & Ongoing Clinical Trials Overview 456

5.192 Neolys Diagnostics Company Overview 457

5.192.1 Neolys Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 457

5.193 Nephrogen LLC Company Overview 458

5.193.1 Nephrogen LLC Pipeline Products & Ongoing Clinical Trials Overview 458

5.194 NG Biotech Company Overview 459

5.194.1 NG Biotech Pipeline Products & Ongoing Clinical Trials Overview 459

5.195 Nirmidas Biotech Inc Company Overview 460

5.195.1 Nirmidas Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 460

5.196 Nortis, Inc. Company Overview 461

5.196.1 Nortis, Inc. Pipeline Products & Ongoing Clinical Trials Overview 461

5.197 Novartis AG Company Overview 462

5.197.1 Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 462

5.198 NOWDiagnostics Inc Company Overview 464

5.198.1 NOWDiagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 464

5.199 NTBIO Diagnostics Inc Company Overview 474

5.199.1 NTBIO Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 474

5.200 Oasis Diagnostics Corp Company Overview 475

5.200.1 Oasis Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 475

5.201 Ohio State University Company Overview 477

5.201.1 Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 477

5.202 Ohio State University Wexner Medical Center Company Overview 478

5.202.1 Ohio State University Wexner Medical Center Pipeline Products & Ongoing Clinical Trials Overview 478

5.203 Ohmx Corp Company Overview 479

5.203.1 Ohmx Corp Pipeline Products & Ongoing Clinical Trials Overview 479

5.204 OJ-Bio Ltd (Inactive) Company Overview 484

5.204.1 OJ-Bio Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 484

5.205 OncoGenesis Corp Company Overview 485

5.205.1 OncoGenesis Corp Pipeline Products & Ongoing Clinical Trials Overview 485

5.206 OPKO Health Inc Company Overview 486

5.206.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 486

5.207 OSLER Diagnostics Ltd Company Overview 490

5.207.1 OSLER Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 490

5.208 OvaGene Oncology Inc Company Overview 491

5.208.1 OvaGene Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 491

5.209 Ovation Diagnostics LLC Company Overview 493

5.209.1 Ovation Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 493

5.210 Pacific Edge Ltd Company Overview 494

5.210.1 Pacific Edge Ltd Pipeline Products & Ongoing Clinical Trials Overview 494

5.211 Pasteur Institute Company Overview 495

5.211.1 Pasteur Institute Pipeline Products & Ongoing Clinical Trials Overview 495

5.212 Pennsylvania State University Company Overview 496

5.212.1 Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview 496

5.213 Philips Healthcare Company Overview 497

5.213.1 Philips Healthcare Pipeline Products & Ongoing Clinical Trials Overview 497

5.214 Philips Healthcare Nederland BV Company Overview 498

5.214.1 Philips Healthcare Nederland BV Pipeline Products & Ongoing Clinical Trials Overview 498

5.215 Phoenix Biosystems Inc Company Overview 499

5.215.1 Phoenix Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 499

5.216 PixCell Medical Technologies Ltd Company Overview 501

5.216.1 PixCell Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 501

5.217 Polytechnic University of Valencia Company Overview 503

5.217.1 Polytechnic University of Valencia Pipeline Products & Ongoing Clinical Trials Overview 503

5.218 Princeton University Company Overview 504

5.218.1 Princeton University Pipeline Products & Ongoing Clinical Trials Overview 504

5.219 ProAxsis Ltd Company Overview 505

5.219.1 ProAxsis Ltd Pipeline Products & Ongoing Clinical Trials Overview 505

5.220 ProciseDx LLC Company Overview 508

5.220.1 ProciseDx LLC Pipeline Products & Ongoing Clinical Trials Overview 508

5.221 ProMIS Neurosciences Inc Company Overview 510

5.221.1 ProMIS Neurosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 510

5.222 Proxim Diagnostics Corp Company Overview 511

5.222.1 Proxim Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 511

5.223 Purdue University Company Overview 514

5.223.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 514

5.224 QLIDA Diagnostics Company Overview 515

5.224.1 QLIDA Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 515

5.225 Qorvo Biotechnologies LLC Company Overview 516

5.225.1 Qorvo Biotechnologies LLC Pipeline Products & Ongoing Clinical Trials Overview 516

5.226 Qualizyme Diagnostics GmbH & Co KG Company Overview 517

5.226.1 Qualizyme Diagnostics GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 517

5.227 QuantuMDx Group Ltd Company Overview 518

5.227.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 518

5.228 Quick, LLC Company Overview 521

5.228.1 Quick, LLC Pipeline Products & Ongoing Clinical Trials Overview 521

5.229 Quidel Corp Company Overview 522

5.229.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 522

5.230 Radiometer Medical ApS Company Overview 528

5.230.1 Radiometer Medical ApS Pipeline Products & Ongoing Clinical Trials Overview 528

5.231 Radisens Diagnostics Ltd Company Overview 529

5.231.1 Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 529

5.232 Renishaw Plc Company Overview 534

5.232.1 Renishaw Plc Pipeline Products & Ongoing Clinical Trials Overview 534

5.233 Resdin Technologies Inc. Company Overview 535

5.233.1 Resdin Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 535

5.234 Roche Diagnostics International Ltd Company Overview 536

5.234.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 536

5.235 Rockefeller University Company Overview 537

5.235.1 Rockefeller University Pipeline Products & Ongoing Clinical Trials Overview 537

5.236 Royal College of Surgeons Ireland Company Overview 538

5.236.1 Royal College of Surgeons Ireland Pipeline Products & Ongoing Clinical Trials Overview 538

5.237 Salignostics Ltd Company Over

Table

Immunochemistry Rapid Tests & POC – Pipeline Products by Stage of Development 47

Immunochemistry Rapid Tests & POC – Pipeline Products by Segment 48

Immunochemistry Rapid Tests & POC – Pipeline Products by Territory 49

Immunochemistry Rapid Tests & POC – Pipeline Products by Regulatory Path 51

Immunochemistry Rapid Tests & POC – Pipeline Products by Estimated Approval Date 52

Immunochemistry Rapid Tests & POC – Ongoing Clinical Trials 53

Immunochemistry Rapid Tests & POC Companies – Pipeline Products by Stage of Development 54

Immunochemistry Rapid Tests & POC – Pipeline Products by Stage of Development 66

1Drop Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 81

One Drop Diagnostic Device – Allergy – Product Status 81

One Drop Diagnostic Device – Allergy – Product Description 81

One Drop Diagnostic Device – Anemia – Product Status 82

One Drop Diagnostic Device – Anemia – Product Description 82

One Drop Diagnostic Device – Cardiovascular Disease – Product Status 82

One Drop Diagnostic Device – Cardiovascular Disease – Product Description 83

4D Pharma PLC Pipeline Products & Ongoing Clinical Trials Overview 84

MicroDx – Product Status 84

MicroDx – Product Description 84

5M Biomed LLC Pipeline Products & Ongoing Clinical Trials Overview 85

Liquid Biopsy Assay – Diabetes – Product Status 85

Liquid Biopsy Assay – Diabetes – Product Description 85

Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 86

Whole Blood Test – TBI – Product Status 86

Whole Blood Test – TBI – Product Description 86

Abbott Point of Care Inc Pipeline Products & Ongoing Clinical Trials Overview 87

i-STAT Alinity – Cancer – Product Status 87

i-STAT Alinity – Cancer – Product Description 87

i-STAT TnI-Nx – Product Status 88

i-STAT TnI-Nx – Product Description 88

Abionic SA Pipeline Products & Ongoing Clinical Trials Overview 89

CRP Based Inflammation Test – Product Status 89

CRP Based Inflammation Test – Product Description 89

PSP IVD CAPSULE – Product Status 90

PSP IVD CAPSULE – Product Description 90

Abionic SA – Ongoing Clinical Trials Overview 91

PSP IVD CAPSULE – A Multicenter, Prospective, Biomarker-result-blinded Observational Study Evaluating Immunoassay Measurements of Pancreatic Stone Protein Performed on Abionic’s abioSCOPE Device with the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis 92

Abwiz Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 93

Diagnostic Test Kit – Kawasaki Disease – Product Status 93

Diagnostic Test Kit – Kawasaki Disease – Product Description 93

Accel Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 94

PreeMo Assay – Product Status 94

PreeMo Assay – Product Description 94

pScreen BNP – Product Status 95

pScreen BNP – Product Description 95

Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 96

Rapid Diagnostic Test – Sickle Cell Anemia – Product Status 96

Rapid Diagnostic Test – Sickle Cell Anemia – Product Description 96

Accord Biomaterials, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 97

Diagnostic Sensor – Pulmonary Arterial Hypertension – Product Status 97

Diagnostic Sensor – Pulmonary Arterial Hypertension – Product Description 97

Affinergy LLC Pipeline Products & Ongoing Clinical Trials Overview 98

Diagnostic Test – Amyotrophic Lateral Sclerosis – Product Status 98

Diagnostic Test – Amyotrophic Lateral Sclerosis – Product Description 98

Phagelock Assay – Product Status 99

Phagelock Assay – Product Description 99

POC Diagnostic Assay – Venous Thromboembolism – Product Status 99

POC Diagnostic Assay – Venous Thromboembolism – Product Description 100

Affinimark Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 101

Affinimark Test Strip – Product Status 101

Affinimark Test Strip – Product Description 101

AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 102

AgPlus Diagnostic System – Cortisol Assay – Product Status 102

AgPlus Diagnostic System – Cortisol Assay – Product Description 102

AgPlus System – Respiratory Diseases Assay – Product Status 103

AgPlus System – Respiratory Diseases Assay – Product Description 103

Akrivis Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 104

Amyloid-ß Biomarker Test – Alzheimer’s Disease – Product Status 104

Amyloid-ß Biomarker Test – Alzheimer’s Disease – Product Description 104

Alaunus Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 105

Rapid Assay – Thyroid Nodules – Product Status 105

Rapid Assay – Thyroid Nodules – Product Description 105

Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 106

NMP35 Test – Product Status 106

NMP35 Test – Product Description 106

NMP48 Test – Product Status 107

NMP48 Test – Product Description 107

Alfa Wassermann Inc Pipeline Products & Ongoing Clinical Trials Overview 108

ACE Alera Clinical Chemistry System – hsCRP – Product Status 108

ACE Alera Clinical Chemistry System – hsCRP – Product Description 108

ACE Axcel Clinical Chemistry System – hsCRP – Product Status 109

ACE Axcel Clinical Chemistry System – hsCRP – Product Description 109

Am Biotechnologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 110

Thioaptamer Diagnostic System – CTx Biomarker – Product Status 110

Thioaptamer Diagnostic System – CTx Biomarker – Product Description 110

Thioaptamer Diagnostic System – OC Biomarker – Product Status 111

Thioaptamer Diagnostic System – OC Biomarker – Product Description 111

Thioaptamers Diagnostic System – NTx Biomarker – Product Status 111

Thioaptamers Diagnostic System – NTx Biomarker – Product Description 112

Ambergen Inc Pipeline Products & Ongoing Clinical Trials Overview 113

AllerBead – Product Status 113

AllerBead – Product Description 113

American Bio Medica Corp Pipeline Products & Ongoing Clinical Trials Overview 114

Rapid Drug Screen – Nicotine – Product Status 114

Rapid Drug Screen – Nicotine – Product Description 114

Rapid ONE – Nicotine – Product Status 115

Rapid ONE – Nicotine – Product Description 115

Rapid TOX Cup II – Nicotine – Product Status 115

Rapid TOX Cup II – Nicotine – Product Description 116

RDS InCup – Nicotine – Product Status 116

RDS InCup – Nicotine – Product Description 116

Amity University Pipeline Products & Ongoing Clinical Trials Overview 117

Nanosensor – Chronic Kidney Disease – Product Status 117

Nanosensor – Chronic Kidney Disease – Product Description 117

Andraka Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 118

Diagnostic Test – Pancreatic Cancer – Product Status 118

Diagnostic Test – Pancreatic Cancer – Product Description 118

Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 119

Cardiac Troponin Biomarker Kit – Product Status 119

Cardiac Troponin Biomarker Kit – Product Description 119

Rapid Blood Test – Intracranial Hemorrhage – Product Status 120

Rapid Blood Test – Intracranial Hemorrhage – Product Description 120

Anteo Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 121

AtomoRapid – Heart Attack – Product Status 121

AtomoRapid – Heart Attack – Product Description 121

Point-Of-Care Bone Metabolism Assay – Product Status 122

Point-Of-Care Bone Metabolism Assay – Product Description 122

Antisoma Therapeutics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 123

eRapid Diagnostic Test – Histamine – Product Status 123

eRapid Diagnostic Test – Histamine – Product Description 123

Astute Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 124

Vidas – Nephrocheck – Product Status 124

Vidas – Nephrocheck – Product Description 124

Atomo Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 125

AtomoRapid – Allergy – Product Status 125

AtomoRapid – Allergy – Product Description 125

AtomoRapid – Celiac Disease – Product Status 126

AtomoRapid – Celiac Disease – Product Description 126

Atonomics A/S (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 127

Premium Trace – B-Type Natriuretic Peptide Assay – Product Status 127

Premium Trace – B-Type Natriuretic Peptide Assay – Product Description 128

Premium Trace – Thyroid-stimulating Hormone Assay – Product Status 128

Premium Trace – Thyroid-stimulating Hormone Assay – Product Description 128

Premium Trace – Vitamin D Assay – Product Status 129

Premium Trace – Vitamin D Assay – Product Description 129

Trace – 1,5-Anhydroglucitol Assay – Product Status 129

Trace – 1,5-Anhydroglucitol Assay – Product Description 130

Trace – Alanine Aminotransferase Assay – Product Status 130

Trace – Alanine Aminotransferase Assay – Product Description 130

Trace – C-Reactive Protein Assay – Product Status 131

Trace – C-Reactive Protein Assay – Product Description 131

Trace – Creatinine Assay – Product Status 131

Trace – Creatinine Assay – Product Description 132

Trace – D-Dimer Test – Product Status 132

Trace – D-Dimer Test – Product Description 132

Trace – Glycated Albumin Test – Product Status 133

Trace – Glycated Albumin Test – Product Description 133

Trace – Plasma Glucose Test – Product Status 133

Trace – Plasma Glucose Test – Product Description 134

Trace – Total IgE Test – Product Status 134

Trace – Total IgE Test – Product Description 134

Trace CDx ADA Assay – Product Status 135

Trace CDx ADA Assay – Product Description 135

Trace CDx Biological Drug Assay – Product Status 135

Trace CDx Biological Drug Assay – Product Description 136

Attogene Corp Pipeline Products & Ongoing Clinical Trials Overview 137

Rapid Diagnostic Assay – Myasthenia Gravis – Product Status 137

Rapid Diagnostic Assay – Myasthenia Gravis – Product Description 137

Attophotonics Biosciences GmbH Pipeline Products & Ongoing Clinical Trials Overview 138

Diagnostic Microfluidic POC – Test – Product Status 138

Diagnostic Microfluidic POC – Test – Product Description 138

Augurix SA Pipeline Products & Ongoing Clinical Trials Overview 139

AUG-POC2 – Product Status 139

AUG-POC2 – Product Description 139

Aurelium BioPharma Inc. Pipeline Products & Ongoing Clinical Trials Overview 140

MMD QPCR Test – Breast Cancer – Product Status 140

MMD QPCR Test – Breast Cancer – Product Description 140

Axim Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 141

Rapid Diagnostic Test – Lacritin – Product Status 141

Rapid Diagnostic Test – Lacritin – Product Description 141

Rapid Quantitative Tear Test – MMP9 – Product Status 142

Rapid Quantitative Tear Test – MMP9 – Product Description 142

Axis-Shield Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

Afinion hsCRP Assay – Product Status 143

Afinion hsCRP Assay – Product Description 143

Axiva Sichem Biotech Pipeline Products & Ongoing Clinical Trials Overview 144

Point Of Care Test – Silicosis – Product Status 144

Point Of Care Test – Silicosis – Product Description 144

Baylor Scott & White Research Institute Pipeline Products & Ongoing Clinical Trials Overview 145

Diagnostic Test – Pancreatic Cancer – Product Status 145

Diagnostic Test – Pancreatic Cancer – Product Description 145

BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 146

Mark-B – CA19-9 Test – Product Status 146

Mark-B – CA19-9 Test – Product Description 147

Mark-B – D-dimer Test – Product Status 147

Mark-B – D-dimer Test – Product Description 148

Mark-B – Myoglobin Test – Product Status 148

Mark-B – Myoglobin Test – Product Description 148

MarkB – AFP Test – Product Status 149

MarkB – AFP Test – Product Description 149

MarkB – CA 125 Test – Product Status 149

MarkB – CA 125 Test – Product Description 150

MarkB – CEA Test – Product Status 150

MarkB – CEA Test – Product Description 151

MarkB – CK-MB Test – Product Status 151

MarkB – CK-MB Test – Product Description 152

MarkB – cTnl Test – Product Status 152

MarkB – cTnl Test – Product Description 152

MarkB – Galectin-3 Test – Product Status 153

MarkB – Galectin-3 Test – Product Description 153

MarkB – hsCRP Test – Product Status 153

MarkB – hsCRP Test – Product Description 154

MarkB – NT-proBNP Test – Product Status 154

MarkB – NT-proBNP Test – Product Description 154

MarkB – PSA Test – Product Status 155

MarkB – PSA Test – Product Description 155

MarkB – ST2 Test – Product Status 155

MarkB – ST2 Test – Product Description 156

Mobile RDT Reader – Carcinoma Embryonic Antigen Test – Product Status 156

Mobile RDT Reader – Carcinoma Embryonic Antigen Test – Product Description 156

Mobile RDT Reader – Prostate Specific Antigen Test – Product Status 157

Mobile RDT Reader – Prostate Specific Antigen Test – Product Description 157

Mobile RDT Reader – Troponin-I Test – Product Status 157

Mobile RDT Reader – Troponin-I Test – Product Description 158

Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 159

POC Diagnostic Test – Cervical Cancer – Product Status 159

POC Diagnostic Test – Cervical Cancer – Product Description 159

Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 160

Lateral Flow BioAssay and Biosensor – Product Status 160

Lateral Flow BioAssay and Biosensor – Product Description 161

Berlin Institute for Health Pipeline Products & Ongoing Clinical Trials Overview 162

Nephrolytix IVDx – Product Status 162

Nephrolytix IVDx – Product Description 162

Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 163

Digital Strip Reader – Cardiac Marker Test – Product Status 163

Digital Strip Reader – Cardiac Marker Test – Product Description 164

Digital Strip Reader – Drugs Of Abuse Test – Product Status 164

Digital Strip Reader – Drugs Of Abuse Test – Product Description 164

Digital Strip Reader – Menopause – Product Status 165

Digital Strip Reader – Menopause – Product Description 165

Magnetic Immunoassay Detection System – Cardiac Myoglobin – Product Status 165

Magnetic Immunoassay Detection System – Cardiac Myoglobin – Product Description 166

Magnetic Immunoassay Detection System – Cardiac Troponin – Product Status 166

Magnetic Immunoassay Detection System – Cardiac Troponin – Product Description 166

Magnetic Immunoassay Detection System – CK MB – Product Status 167

Magnetic Immunoassay Detection System – CK MB – Product Description 167

BioCurex Inc Pipeline Products & Ongoing Clinical Trials Overview 168

RECAF Blood Test – Product Status 168

RECAF Blood Test – Product Description 168

Biodesix Inc Pipeline Products & Ongoing Clinical Trials Overview 169

PD-L1 Blood Based Diagnostic Test – Product Status 169

PD-L1 Blood Based Diagnostic Test – Product Description 169

Biodesix Inc – Ongoing Clinical Trials Overview 170

PD-L1 Blood Based Diagnostic Test – A Study to Evaluate the Clinical Utility of Biomarkers, Including the Proteomic Primary Immune Response (PIR) Test, for Front-line Non-small Cell Lung Cancer (NSCLC) Patients Receiving Immunotherapy with and without the Addition of Systemic Platinum-based Chemotherapy who Have High Expression of Program Death Ligand-1 (PD-L1) on Their Tumor Cells 171

PD-L1 Blood Based Diagnostic Test – Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated with PD-1/PD-L1 Based Therapy with or without the Addition of Platinum Based Chemotherapy 171

Biogenes Technologies Sdn Bhd Pipeline Products & Ongoing Clinical Trials Overview 172

Ultralab – Colorectal Cancer Assay – Product Status 172

Ultralab – Colorectal Cancer Assay – Product Description 172

BioMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 173

SSAT-Amantadine Assay – ELISA KIT – Product Status 173

SSAT-Amantadine Assay – ELISA KIT – Product Description 173

Bio-Me AS Pipeline Products & Ongoing Clinical Trials Overview 174

Comprehensive Diagnostic Test – Allergy and Asthma – Product Status 174

Comprehensive Diagnostic Test – Allergy and Asthma – Product Description 174

BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 175

Point of Care Test – Testosterone – Product Status 175

Point of Care Test – Testosterone – Product Description 175

Point of Care Test – Vitamin D – Product Status 176

Point of Care Test – Vitamin D – Product Description 176

Rapid Drug Overdose Test – Cocaine – Product Status 176

Rapid Drug Overdose Test – Cocaine – Product Description 177

Rapid Drug Overdose Test – Methamphetamine – Product Status 177

Rapid Drug Overdose Test – Methamphetamine – Product Description 177

Rapid Drug Overdose Test – Morphine – Product Status 178

Rapid Drug Overdose Test – Morphine – Product Description 178

Rapid Drug Overdose Test – PCP – Product Status 178

Rapid Drug Overdose Test – PCP – Product Description 179

Rapid Drug Overdose Test – THC – Product Status 179

Rapid Drug Overdose Test – THC – Product Description 179

Rapid Quantitative Acetaminophen Detection Assay – Product Status 180

Rapid Quantitative Acetaminophen Detection Assay – Product Description 180

Biomerica Inc Pipeline Products & Ongoing Clinical Trials Overview 181

InFoods – Depression – Product Status 181

InFoods – Depression – Product Description 182

InFoods – Dermatology – Product Status 182

InFoods – Dermatology – Product Description 182

InFoods – Migraine – Product Status 183

InFoods – Migraine – Product Description 183

InFoods IBS – Product Status 183

InFoods IBS – Product Description 184

bioMerieux SA Pipeline Products & Ongoing Clinical Trials Overview 185

VIDAS TBI – Product Status 185

VIDAS TBI – Product Description 185

Bioo Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 186

Rapid Test Kit – MethylGlyoxal – Product Status 186

Rapid Test Kit – MethylGlyoxal – Product Description 186

Biopeptides Corp Pipeline Products & Ongoing Clinical Trials Overview 187

Point-of-Care Assay – Lyme Disease – Product Status 187

Point-of-Care Assay – Lyme Disease – Product Description 187

Biopico Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 188

SMART – Systemic Lupus Erythematosus – Product Status 188

SMART – Systemic Lupus Erythematosus – Product Description 188

BiOracle Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 189

Appytest – Product Status 189

Appytest – Product Description 189

biO1042 Test – Product Status 190

biO1042 Test – Product Description 190

Biosensia Ltd Pipeline Products & Ongoing Clinical Trials Overview 191

RapiPlex – Drugs Of Abuse Assay – Product Status 191

RapiPlex – Drugs Of Abuse Assay – Product Description 191

RapiPlex – Myoglobin Assay – Product Status 192

RapiPlex – Myoglobin Assay – Product Description 192

RapiPlex Platform – Kidney Marker Assay – Product Status 192

RapiPlex Platform – Kidney Marker Assay – Product Description 193

Biosensorix Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 194

ELLI Assay – Acute Kidney Injury – Product Status 194

ELLI Assay – Acute Kidney Injury – Product Description 194

Biostealth, Inc. Pipeline Products & Ongoing Clinical Trials Overview 195

Point-Of-Care Assay – B-Type Natriuretic Peptide – Product Status 195

Point-Of-Care Assay – B-Type Natriuretic Peptide – Product Description 195

Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 196

Spinit – D-dimer Test – Product Status 196

Spinit – D-dimer Test – Product Description 196

BioTron Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 197

ANTI-TMCS Test – Product Status 197

ANTI-TMCS Test – Product Description 197

Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 198

Allereye XT – Product Status 198

Allereye XT – Product Description 198

IL6 And IL8 POC Test – Product Status 199

IL6 And IL8 POC Test – Product Description 199

Symphony hsTNT/I – Product Status 199

Symphony hsTNT/I – Product Description 200

Symphony IL-6 Sepsis – Product Status 200

Symphony IL-6 Sepsis – Product Description 200

Symphony NT-pro BNP – Product Status 201

Symphony NT-pro BNP – Product Description 201

Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 202

AFIAS 6 – FSH Plus Assay – Product Status 203

AFIAS 6 – FSH Plus Assay – Product Description 203

AFIAS-6 – Cystatin C Test – Product Status 203

AFIAS-6 – Cystatin C Test – Product Description 204

AFIAS-6 Progesterone Assay – Product Status 204

AFIAS-6 Progesterone Assay – Product Description 204

AFIAS-6 RF IgM Assay – Product Status 205

AFIAS-6 RF IgM Assay – Product Description 205

AFIAS-6 Vitamin D Assay – Product Status 205

AFIAS-6 Vitamin D Assay – Product Description 206

Ichroma 10 – CA 125 Assay – Product Status 206

Ichroma 10 – CA 125 Assay – Product Description 206

Ichroma 10 – CA 15-3 Assay – Product Status 207

Ichroma 10 – CA 15-3 Assay – Product Description 207

Ichroma 10 – CA 19-9 Assay – Product Status 207

Ichroma 10 – CA 19-9 Assay – Product Description 208

Ichroma 10 – Cyfra 21-1 Assay – Product Status 208

Ichroma 10 – Cyfra 21-1 Assay – Product Description 208

Ichroma 10 – ST2 Assay – Product Status 209

Ichroma 10 – ST2 Assay – Product Description 209

Ichroma 10 – Toxoplasma IgG/IgM Assay – Product Status 209

Ichroma 10 – Toxoplasma IgG/IgM Assay – Product Description 210

Ichroma II – CA 125 Assay – Product Status 210

Ichroma II – CA 125 Assay – Product Description 210

Ichroma II – CA 15-3 Assay – Product Status 211

Ichroma II – CA 15-3 Assay – Product Description 211

Ichroma II – CA 19-9 Assay – Product Status 211

Ichroma II – CA 19-9 Assay – Product Description 212

Ichroma II – Cyfra 21-1 Assay – Product Status 212

Ichroma II – Cyfra 21-1 Assay – Product Description 212

Ichroma II – POC ST2 Assay – Product Status 213

Ichroma II – POC ST2 Assay – Product Description 213

Ichroma II – Toxoplasma IgG/IgM Assay – Product Status 213

Ichroma II – Toxoplasma IgG/IgM Assay – Product Description 214

Ichroma III – CA 125 Assay – Product Status 214

Ichroma III – CA 125 Assay – Product Description 214

Ichroma III – CA 19-9 Assay – Product Status 215

Ichroma III – CA 19-9 Assay – Product Description 215

Ichroma III – Cyfra 21-1 Assay – Product Status 215

Ichroma III – Cyfra 21-1 Assay – Product Description 216

Ichroma III – ST2 Assay – Product Status 216

Ichroma III – ST2 Assay – Product Description 216

Ichroma III – Toxoplasma IgG/IgM Assay – Product Status 217

Ichroma III – Toxoplasma IgG/IgM Assay – Product Description 217

Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 218

2-Methoxyestradiol Immunoassay – Product Status 218

2-Methoxyestradiol Immunoassay – Product Description 218

Diagnostic Immunoassay – Kawasaki Disease – Product Status 219

Diagnostic Immunoassay – Kawasaki Disease – Product Description 219

Brainbox Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 220

BRAINBox Geriatrics – Product Status 220

BRAINBox Geriatrics – Product Description 220

BRAINBox Pediatrics – Product Status 221

BRAINBox Pediatrics – Product Description 221

BRAINBox TBI – Adults – Product Status 221

BRAINBox TBI – Adults – Product Description 222

Brainbox Solutions Inc – Ongoing Clinical Trials Overview 223

BRAINBox TBI – Adults – HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma II 224

BRAINBox TBI – Adults – Head Injury Serum Markers and Multi-modalities for Assessing Response to Trauma in Geriatrics Patients: HeadSMART Geriatrics 224

Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 225

Micropoc-Pro – Kidney Injury Marker Assay – Product Status 225

Micropoc-Pro – Kidney Injury Marker Assay – Product Description 225

Micropoc-pro – Troponin-I Assay – Product Status 226

Micropoc-pro – Troponin-I Assay – Product Description 226

CardioGenics Inc Pipeline Products & Ongoing Clinical Trials Overview 227

Heart Failure Genomics Risk Test – Product Status 227

Heart Failure Genomics Risk Test – Product Description 227

Heart Failure Risk Stratification Test – Product Status 228

Heart Failure Risk Stratification Test – Product Description 228

Troponin-I Test – Product Status 228

Troponin-I Test – Product Description 229

Cascade Metrix LLC Pipeline Products & Ongoing Clinical Trials Overview 230

Multiple Blood Analytes Test – Product Status 230

Multiple Blood Analytes Test – Product Description 230

Cellex Inc Pipeline Products & Ongoing Clinical Trials Overview 231

Point-Of-Care Test – Antibiotic Resistance – Product Status 231

Point-Of-Care Test – Antibiotic Resistance – Product Description 231

Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 232

DPP Cancer Assay – Product Status 232

DPP Cancer Assay – Product Description 232

DPP Traumatic Brain Injury Assay – Product Status 233

DPP Traumatic Brain Injury Assay – Product Description 233

Point-of-Care Companion Diagnostic Test – Product Status 233

Point-of-Care Companion Diagnostic Test – Product Description 234

Children’s Hospital of Philadelphia Pipeline Products & Ongoing Clinical Trials Overview 235

Non-invasive Biomarker Test – Crohn’s Disease – Product Status 235

Non-invasive Biomarker Test – Crohn’s Disease – Product Description 235

POC Diagnostic Test – Systemic Lupus Nephritis – Product Status 236

POC Diagnostic Test – Systemic Lupus Nephritis – Product Description 236

Cincinnati Children’s Hospital Medical Center Pipeline Products & Ongoing Clinical Trials Overview 237

Urinary Biomarker Panel – AKI – Product Status 237

Urinary Biomarker Panel – AKI – Product Description 237

Claro Scientific LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 238

Diagnostic Test – M/aRDT – Product Status 238

Diagnostic Test – M/aRDT – Product Description 238

Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 239

Liquid Biopsy Test – Cancer Screening – Product Status 239

Liquid Biopsy Test – Cancer Screening – Product Description 239

Cognizance Biomarkers LLC Pipeline Products & Ongoing Clinical Trials Overview 240

EvoScoreDX – Product Status 240

EvoScoreDX – Product Description 240

Cognizance Biomarkers LLC – Ongoing Clinical Trials Overview 241

EvoScoreDX – A Clinical Study to Evaluate the Efficacy of Cognizance’s EvoScoreDX Protein Biomarker Assay in Accurately Distinguishing the Epileptic Seizures from Psychogenic Seizures 242

Contango Asset Management Ltd Pipeline Products & Ongoing Clinical Trials Overview 243

Biomarker Test – Cystic Fibrosis – Product Status 243

Biomarker Test – Cystic Fibrosis – Product Description 243

Coris BioConcept Pipeline Products & Ongoing Clinical Trials Overview 244

Microfluidic Chip – Product Status 244

Microfluidic Chip – Product Description 244

Correlia Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 245

Electrokinetic Lateral Flow Test – Product Status 245

Electrokinetic Lateral Flow Test – Product Description 245

CTK Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 246

Onsite Leprosy Ab Rapid Test – Product Status 246

Onsite Leprosy Ab Rapid Test – Product Description 246

Curetis GmbH Pipeline Products & Ongoing Clinical Trials Overview 247

Unyvero Analyzer A30 RQ – Immuno-Compromised Patient Panel – Product Status 247

Unyvero Analyzer A30 RQ – Immuno-Compromised Patient Panel – Product Description 247

Cx Precision Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 248

Lewy Body Dementia Rule-Out Test – Product Status 248

Lewy Body Dementia Rule-Out Test – Product Description 248

Parkinson’s Disease Rule-Out Test – Product Status 249

Parkinson’s Disease Rule-Out Test – Product Description 249

Daktari Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 250

Daktari Sickle Cell Test – Product Status 250

Daktari Sickle Cell Test – Product Description 250

Dartmouth College Pipeline Products & Ongoing Clinical Trials Overview 251

ISH/IHC Assay – Colorectal Cancer – Product Status 251

ISH/IHC Assay – Colorectal Cancer – Product Description 251

ISH/IHC Assay – Lung Cancer – Product Status 252

ISH/IHC Assay – Lung Cancer – Product Description 252

ISH/IHC Assay – Pancreatic Cancer – Product Status 252

ISH/IHC Assay – Pancreatic Cancer – Product Description 253

ISH/IHC Assay – Prostate Cancer – Product Status 253

ISH/IHC Assay – Prostate Cancer – Product Description 253

DiabetOmics Inc Pipeline Products & Ongoing Clinical Trials Overview 254

Glucema – Product Status 254

Glucema – Product Description 254

Insudex – Product Status 255

Insudex – Product Description 255

Diafir Pipeline Products & Ongoing Clinical Trials Overview 256

Diagnostic Assay – Bladder Cancer – Product Status 256

Diagnostic Assay – Bladder Cancer – Product Description 256

NASHMIR – Product Status 257

NASHMIR – Product Description 257

DiagNodus Ltd Pipeline Products & Ongoing Clinical Trials Overview 258

Point Of Care Test – Inflammatory Bowel Disease – Product Status 258

Point Of Care Test – Inflammatory Bowel Disease – Product Description 258

DiagnosTear Ltd. Pipeline Products & Ongoing Clinical Trials Overview 259

TeaRx – Product Status 259

TeaRx – Product Description 259

DiagnosTear Ltd. – Ongoing Clinical Trials Overview 260

TeaRx – Clinical Trial to Examine the TeaRx Technology for Diagnose, Personalize Treatment and Monitoring of Dry Eye Syndrome 261

TeaRx – To Examine the Composition of the Tear Film Using TeaRx Technology 261

Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 262

Paper-Based Diagnostic Device – Anemia – Product Status 262

Paper-Based Diagnostic Device – Anemia – Product Description 262

Paper-Based Diagnostic Device – Hypertensive Disorders – Product Status 263

Paper-Based Diagnostic Device – Hypertensive Disorders – Product Description 263

Point-Of-Care Diagnostic Assay – Immunity Assessment – Product Status 263

Point-Of-Care Diagnostic Assay – Immunity Assessment – Product Description 264

Dianax S.R.L Pipeline Products & Ongoing Clinical Trials Overview 265

Dianax Device – HbA1c Test – Product Status 265

Dianax Device – HbA1c Test – Product Description 265

Dianax Device – Chronic Kidney Disease Test – Product Status 266

Dianax Device – Chronic Kidney Disease Test – Product Description 266

Dianax Device – CRP Test – Product Status 266

Dianax Device – CRP Test – Product Description 267

DiaSys Diagnostic Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 268

InnovaStar – Kidney Disease Assay – Product Status 268

InnovaStar – Kidney Disease Assay – Product Description 268

Diazyme Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 269

ProADM Point-of-Care – Product Status 269

ProADM Point-of-Care – Product Description 269

Dimerix Ltd Pipeline Products & Ongoing Clinical Trials Overview 270

VisuaLine Multi Dip Panel – Product Status 270

VisuaLine Multi Dip Panel – Product Description 270

DioTeX Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 271

Diagnostic Device – Internal Hemorrhage – Product Status 271

Diagnostic Device – Internal Hemorrhage – Product Description 271

DRD Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 272

Rapid Test – Acute Stroke – Product Status 272

Rapid Test – Acute Stroke – Product Description 272

Rapid Test – Cerebral Ischemia – Product Status 273

Rapid Test – Cerebral Ischemia – Product Description 273

Rapid Test – Posttraumatic Epilepsy – Product Status 273

Rapid Test – Posttraumatic Epilepsy – Product Description 274

Rapid Test – TBI – Product Status 274

Rapid Test – TBI – Product Description 274

Duke University Pipeline Products & Ongoing Clinical Trials Overview 275

Multianalyte 2-D Diffusion Point-Of-Care Assay – Cardiac Infarction – Product Status 275

Multianalyte 2-D Diffusion Point-Of-Care Assay – Cardiac Infarction – Product Description 275

Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview 276

Diagnostic Test – Blood Coagulation Disorders – Product Status 276

Diagnostic Test – Blood Coagulation Disorders – Product Description 276

Diagnostic Test – Cardiovascular Risk – Product Status 277

Diagnostic Test – Cardiovascular Risk – Product Description 277

Eachy Biopharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 278

Combination Kit – ACS – Product Status 278

Combination Kit – ACS – Product Description 278

Home Test Kit – ACS – Product Status 279

Home Test Kit – ACS – Product Description 279

Screening Test – Diabetic Nephropathy – Product Status 279

Screening Test – Diabetic Nephropathy – Product Description 280

Eclipse Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 281

ELLI Assay – Stroke Monitoring – Product Status 281

ELLI Assay – Stroke Monitoring – Product Description 281

Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 282

CT3 – Cyfra21-1 Assay – Product Status 282

CT3 – Cyfra21-1 Assay – Product Description 283

CT3 – FT3 Assay – Product Status 283

CT3 – FT3 Assay – Product Description 283

CT3 – FT4 Assay – Product Status 284

CT3 – FT4 Assay – Product Description 284

CT3 – Prolactin Assay – Product Status 284

CT3 – Prolactin Assay – Product Description 284

m1

Figures

Immunochemistry Rapid Tests & POC – Pipeline Products by Stage of Development 47

Immunochemistry Rapid Tests & POC – Pipeline Products by Segment 48

Immunochemistry Rapid Tests & POC – Pipeline Products by Territory 49

Immunochemistry Rapid Tests & POC – Pipeline Products by Regulatory Path 51

Immunochemistry Rapid Tests & POC – Pipeline Products by Estimated Approval Date 52

Immunochemistry Rapid Tests & POC – Ongoing Clinical Trials 53

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