Bacteriology 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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Bacteriology Rapid Tests Poc Pipeline Product Market Report Overview

Bacteriology Rapid Tests & POC comprises rapid test kits intended for rapid diagnosis, with immediate results, through immuno assays for Chlamydia, H. pylori, Streptococci, and Syphilis. The Bacteriology Rapid Tests & POC pipeline market research report provides comprehensive information about the Bacteriology Rapid Tests & 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.

Bacteriology Rapid Tests & POC Pipeline Products Market Segments

Other bacteriology rapid tests & POC tests, chlamydia trachomatis tests, group A streptococcus tests are some of the key segments in the pipeline product.

 Bacteriology Rapid Tests & POC Pipeline Products Market Analysis, by Segments, 2022(%)

 Bacteriology Rapid Tests & POC Pipeline Products Market Analysis, by Segments

For more segment insights into the bacteriology rapid tests & POC pipeline products market, download a free report sample 

Bacteriology Rapid Tests & POC Pipeline Products Market Segmentation, by Territories 

Some of the key territories with products in the pipeline are the US, Europe, China, Canada, Taiwan, Singapore, Japan, India, Russia, Israel, South Korea, and others. As of September 2022, the US has the highest number of products in the pipeline out of them all.

Bacteriology Rapid Tests & POC Pipeline Products Market Analysis, by Territories, 2022(%)

Bacteriology Rapid Tests & POC Pipeline Products Market Analysis, by Territories  For more territory insights into the Bacteriology Rapid Tests & POC pipeline products market, download a free report sample  

Bacteriology Rapid Tests & POC Pipeline Products Market Segmentation by Key Regulatory Paths 

The key regulatory paths followed by the POC pipeline products market are 510(K), CE-IVD, NMPA, HSA, BOPA, ICAC, MDL, Ninsho, and TGA. Most of the products follow the 510(K) pathway to enter the market.

 Bacteriology Rapid Tests & POC Pipeline Products Market Analysis, by Regulatory Paths, 2022(%)

 Bacteriology Rapid Tests & POC Pipeline Products Market Analysis, by Regulatory Paths 

For more Bacteriology Rapid Tests & POC pipeline regulatory path insights, download a free report sample  

Competitive Landscape 

Some of the leading companies in the Bacteriology Rapid Tests & POC pipeline products market are Abbott Diagnostics, Abacus Diagnostica Ltd, Accel Diagnostics LLC, and Access Bio Inc.

Abacus Diagnostica Ltd (Abacus Diagnostica): It is a Finnish molecular diagnostics company that offers rapid molecular testing utilizing the patented GenomEra technology. It offers products such as GenomEra CDX, All-in-one PCR, and RT-PCR test chips, critical human pathogens, and antibiotic resistance markers such as C difficile, Norovirus, and MRSA and other critical human pathogens and antibiotic resistance markers. It also provides NOROVIRUS, MRSA/SA AC, MRSA/SA MULTI SWAB, GBS, STREPTOCOCCUS PNEUMONIAE, and automated analyzer such as built-in PCR amplification and detection, easy-to-use software and result interpretation.

Abbott Diagnostics (Abbott): It is a subsidiary of Abbott Laboratories. It is a manufacturer of in vitro diagnostic systems and tests. The company offers various core laboratory products, molecular point of care products, transfusion medicine, professional services, and a diagnostics portfolio. Abbott products portfolio includes laboratory systems for automation molecular diagnostic systems and point of care systems for blood analysis. The company products find application in therapeutic drug monitoring, measurement of antibodies and antigens, and screening and diagnosis of cancer. Abbott serves blood banks, hospitals, commercial laboratories, government agencies, patient care testing sites, and plasma protein therapeutic companies.

Bacteriology Rapid Tests & POC Pipeline Products Market Report Overview 

Key Segments Other Bacteriology Rapid Tests & POC Tests, Chlamydia trachomatis Tests, Group A Streptococcus Tests
Key Territories The US, Europe, China, Canada, Taiwan, Singapore, Japan, India, Russia, Israel, South Korea, and Others
Key Regulatory Paths 510(K), CE-IVD, NMPA, HSA, BOPA, ICAC, MDL, Ninsho, and TGA
Leading Companies Abbott Diagnostics, Abacus Diagnostica Ltd, Accel Diagnostics LLC, and Access Bio Inc.

Segments Covered in the Report

Bacteriology Rapid Tests & POC Pipeline Products Market Segments Outlook

  • Other Bacteriology Rapid Tests & POC Tests
  • Chlamydia trachomatis Tests
  • Group A Streptococcus Tests

Bacteriology Rapid Tests & POC Pipeline Products Market Territories Outlook

  • The US
  • Europe
  • China
  • Canada
  • Taiwan
  • Singapore
  • Japan
  • India
  • Russia
  • Israel
  • South Korea

Bacteriology Rapid Tests & POC Pipeline Products Market Regulatory Paths Outlook

  • 510(K)
  • CE-IVD
  • NMPA
  • HSA
  • BOPA
  • ICAC
  • MDL
  • Ninsho
  • TGA

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 Bacteriology Rapid Tests & 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.

Abacus Diagnostica Ltd
Abbott Diagnostics
Accel Diagnostics LLC
Access Bio Inc
Access to Advanced Health Institute
Adaptive Phage Therapeutics Inc
Adnavance Technologies Inc.
Advanced Liquid Logic Inc
AgPlus Diagnostics LTD
AI Biosciences, Inc.
Aidian Oy
Akonni Biosystems Inc
Alere Inc
All India Institute of Medical Sciences
Angle Biosciences Inc
Applied Nanodetectors Ltd
Arbor Vita Corp
Arizona State University
Attoplex Co Ltd
Avacta Group Plc
Avesthagen Ltd
B&W Tek Inc
BATM Advanced Communications Ltd
BBB Technologies Inc
Becton Dickinson and Co
Binx Health Inc
Bio-AMD Inc
BioAssay Works, LLC
BioDesign Institute at Arizona State University
BioDetection Instruments, LLC
BioFire Diagnostics Inc
Biogenes Technologies Sdn Bhd
Biogenix Inc Pvt Ltd
Biomagnetics Diagnostics Corp
Biomedical Diagnostics Institute
bioMerieux SA
Biomolecular Determination SA
Biopromic AB
BiOracle Ltd (Inactive)
Bio-Rad Laboratories Inc
Biotech Consortium India Ltd
Blaze Venture Technologies Limited
Blue Comet Medical Solutions
Bluejay Diagnostics Inc
Boditech Med Inc
Bosch Healthcare Solutions GmbH
Boston University
Brown University
Bruker Daltonik GmbH
Burnet Institute
C4Diagnostics SAS
CAMPTON Diagnostics UG
CAN Diagnostics Inc
Carclo Diagnostic Solutions Ltd
Cardiff University
CelerDx Inc
Cellex Inc
Cepheid Inc
CFD Research Corp
Charles University
Checkable Medical Corp
Chembio Diagnostic Systems Inc
Ciencia
Claremont BioSolutions
CNine Biosolutions LLC
Cobio Diagnostics Inc
Co-Diagnostics Inc
Colorado State University
Contango Asset Management Ltd
Cupid Ltd
Curiosity Diagnostics Sp zoo
Day Zero Diagnostics Inc
DCN Diagnostics
Department of Biomedical Engineering Columbia University
DestiNA Genomica SL
Diafir
Diagnostics For All Inc
Diagnostics for the Real World (Europe) Ltd
DNAE Group Holdings Ltd
Domus Diagnostics Inc
Duke University
DxDiscovery Inc
DxNA LLC
Dynasil Corporation of America
ECI Biotech Inc.
Edan Instruments Inc
Ellume Ltd
Elvesys Inc
Embryyo Technologies Pvt Ltd
EMPE Diagnostics AB
Enigma Diagnostics Ltd (Inactive)
ENTvantage Dx
ERBA Molecular Ltd
Evolve Biosystems Inc
Fast Track Diagnostics Ltd
First Light Diagnostics Inc
FK-Biotecnologia SA
Fluxergy LLC
Foundation for Innovative New Diagnostics
Fred Hutchinson Cancer Research Center
Free University of Brussels
Fyodor Biotechnologies, Inc.
GE Healthcare
GeneBio Systems Inc
genedrive plc
GeneEx, Inc (Inactive)
GenePOC Inc
Genetic Signatures Ltd
Global BioDiagnostics Corp.
GNA Biosolutions GmbH
Goodgene Inc
Gradientech AB
Great Basin Scientific Inc.
Group K Diagnostics
Guanine Inc
Helixbind Inc
HiberGene Diagnostics Ltd
Hologic Inc
Hutman Diagnostics AG
iCubate Inc
ID Genomics Inc
IdbyDNA Inc
Identifysensors LLC
IDL Biotech AB
Illucidx Inc
ImevaX GmbH
ImmuneMed Inc
Immunetics Inc
Immunexpress Pty Ltd
Immuno Technologies Inc
ImmunoScience Inc
Imperial College London
InBios International Inc
Innatoss Laboratories BV
Innova Biotechnology Co Ltd
Innova Medical Group Inc
Insilixa, Inc.
Institute for Development Research
Institute of Molecular Biology of Parana
JAJ International Inc
Johns Hopkins University
Kaneka Corp
Kenta Biotech Ltd
Kephera Diagnostics LLC
Leiden University Medical Center
Lenima Field Diagnostics LLC
Lexagene Holdings Inc
LightDeck Diagnostics Inc
Loop Dx
LPS-BioSciences
Lucigen Corp
Lucira Health Inc
Luminostics Inc
LumiraDx Ltd
Lynntech Inc
March of Dimes Foundation
Massachusetts General Hospital
Medical Research Council
Medical Research Council Unit The Gambia
MedMira Inc
Meridian Bioscience Inc
Mesa Tech International, Inc.
Metropolis Healthcare Ltd
Micronics Inc
Molbio Diagnostics Pvt Ltd
Molnlycke Health Care AB
MyMD Pharmaceuticals, Inc
Nal Von Minden GmbH
Nanodetection Technology Inc
Nanopore Diagnostics, LLC
NanoRepro AG
Nemis Technologies AG
NetBio, Inc.
Northwestern University
NOWDiagnostics Inc
NuGenerex Diagnostics LLC
Omega Diagnostics Group Plc
One BioMed Pte Ltd
Ontera Inc
OpGen Inc
OPKO Health Inc
OptiCul Diagnostics Ltd.
Osaka University
Pamlico Biopharma Inc
Pattern Bioscience Inc
PBD Biotech Ltd
Philips Healthcare
Phoenix Biosystems Inc
Photon Biosciences LLC
PreDxion Bio Inc
Prime Discoveries Inc
PriTest Inc.
Prominex Inc
ProteinLogic Ltd
Proxim Diagnostics Corp
Qiagen NV
Qorvo Biotechnologies LLC
QSM Diagnostics Inc
QuantaLife Inc (Inactive)
Quanterix Corp
QuantuMDx Group Ltd
QuickCheck Health Inc
Quidel Corp
Quintain NanoSystems (Inactive)
Randox Laboratories Ltd
Rapid Diagnostic Pvt Ltd
RNA Disease Diagnostics Inc
Rockefeller University
Rutgers Biomedical and Health Sciences
Rutgers New Jersey Medical School
Salus Discovery LLC
Saureus, Inc.
Scanogen Inc
Selfdiagnostics OU
SensDx SA
Senzo Inc
SeroSelectTB
SLS Cell Cure Technologies Pty Ltd
Smiths Detection Inc
Spanish National Research Council
Sphingotec GmbH
SpinDiag GmbH
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Sri Narayani Hospital & Research Center
Stanford University
Stellar Diagnostics India Pvt Ltd
T2 Biosystems Inc
Talis Biomedical Corp
Tangen Biosciences Inc
TB Biosciences, Inc.
Technical University of Munich
The Forsyth Institute
The Translational Genomics Research Institute
Thermo Fisher Scientific Inc
ThreeFold Sensors (Inactive)
Trinity Biotech Plc
Tritek Innovation Pvt Ltd
True Diagnostics Inc
TwistDx Ltd
University of Antwerp
University of Bath
University of California Berkeley
University of California Irvine
University of California San Diego
University of Cambridge
University of Cape Town
University of Central Florida
University of Delhi
University of Ghana
University of Kansas Medical Center
University of Michigan
University of Nevada Reno
University of Oxford
University of Queensland
University of Rochester
University of Strathclyde
University of Texas at Austin
University of Virginia
University of Washington
Ustar Biotechnologies (Hangzhou) Ltd.
Wave 80 Biosciences Inc
Wellstat Diagnostics LLC
Xagenic Inc (Inactive)
XCR Diagnostics Inc
Yaathum Biotech Pvt Ltd
Yale University
ZiP Diagnostics Pty Ltd

Table of Contents

1 Table of Contents 3

|1.1 List of Tables 14

|1.2 List of Figures 38

2 Introduction 39

2.1 Bacteriology Rapid Tests & POC Overview 39

3 Products under Development 40

3.1 Bacteriology Rapid Tests & POC – Pipeline Products by Stage of Development 40

3.2 Bacteriology Rapid Tests & POC – Pipeline Products by Segment 41

3.3 Bacteriology Rapid Tests & POC – Pipeline Products by Territory 42

3.4 Bacteriology Rapid Tests & POC – Pipeline Products by Regulatory Path 44

3.5 Bacteriology Rapid Tests & POC – Pipeline Products by Estimated Approval Date 45

3.6 Bacteriology Rapid Tests & POC – Ongoing Clinical Trials 46

4 Bacteriology Rapid Tests & POC – Pipeline Products under Development by Companies 47

4.1 Bacteriology Rapid Tests & POC Companies – Pipeline Products by Stage of Development 47

4.2 Bacteriology Rapid Tests & POC – Pipeline Products by Stage of Development 57

5 Bacteriology Rapid Tests & POC Companies and Product Overview 69

5.1 Company Overview 69

5.2 Abacus Diagnostica Ltd Company Overview 69

5.2.1 Abacus Diagnostica Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

5.3 Abbott Diagnostics Company Overview 77

5.3.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 77

5.4 Accel Diagnostics LLC Company Overview 78

5.4.1 Accel Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 78

5.5 Access Bio Inc Company Overview 79

5.5.1 Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.6 Access to Advanced Health Institute Company Overview 81

5.6.1 Access to Advanced Health Institute Pipeline Products & Ongoing Clinical Trials Overview 81

5.7 Adaptive Phage Therapeutics Inc Company Overview 82

5.7.1 Adaptive Phage Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 82

5.8 Adnavance Technologies Inc. Company Overview 85

5.8.1 Adnavance Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 85

5.9 Advanced Liquid Logic Inc Company Overview 86

5.9.1 Advanced Liquid Logic Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.10 AgPlus Diagnostics LTD Company Overview 87

5.10.1 AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 87

5.11 AI Biosciences, Inc. Company Overview 88

5.11.1 AI Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88

5.12 Aidian Oy Company Overview 89

5.12.1 Aidian Oy Pipeline Products & Ongoing Clinical Trials Overview 89

5.13 Akonni Biosystems Inc Company Overview 90

5.13.1 Akonni Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.14 Alere Inc Company Overview 92

5.14.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.15 All India Institute of Medical Sciences Company Overview 97

5.15.1 All India Institute of Medical Sciences Pipeline Products & Ongoing Clinical Trials Overview 97

5.16 Angle Biosciences Inc Company Overview 99

5.16.1 Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 99

5.17 Applied Nanodetectors Ltd Company Overview 101

5.17.1 Applied Nanodetectors Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

5.18 Arbor Vita Corp Company Overview 102

5.18.1 Arbor Vita Corp Pipeline Products & Ongoing Clinical Trials Overview 102

5.19 Arizona State University Company Overview 105

5.19.1 Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 105

5.20 Attoplex Co Ltd Company Overview 106

5.20.1 Attoplex Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

5.21 Avacta Group Plc Company Overview 107

5.21.1 Avacta Group Plc Pipeline Products & Ongoing Clinical Trials Overview 107

5.22 Avesthagen Ltd Company Overview 108

5.22.1 Avesthagen Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

5.23 B&W Tek Inc Company Overview 109

5.23.1 B&W Tek Inc Pipeline Products & Ongoing Clinical Trials Overview 109

5.24 BATM Advanced Communications Ltd Company Overview 110

5.24.1 BATM Advanced Communications Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

5.25 BBB Technologies Inc Company Overview 111

5.25.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 111

5.26 Becton Dickinson and Co Company Overview 114

5.26.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 114

5.27 Binx Health Inc Company Overview 115

5.27.1 Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 115

5.28 Bio-AMD Inc Company Overview 123

5.28.1 Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 123

5.29 BioAssay Works, LLC Company Overview 124

5.29.1 BioAssay Works, LLC Pipeline Products & Ongoing Clinical Trials Overview 124

5.30 BioDesign Institute at Arizona State University Company Overview 125

5.30.1 BioDesign Institute at Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 125

5.31 BioDetection Instruments, LLC Company Overview 126

5.31.1 BioDetection Instruments, LLC Pipeline Products & Ongoing Clinical Trials Overview 126

5.32 BioFire Diagnostics Inc Company Overview 127

5.32.1 BioFire Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 127

5.33 Biogenes Technologies Sdn Bhd Company Overview 128

5.33.1 Biogenes Technologies Sdn Bhd Pipeline Products & Ongoing Clinical Trials Overview 128

5.34 Biogenix Inc Pvt Ltd Company Overview 131

5.34.1 Biogenix Inc Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

5.35 Biomagnetics Diagnostics Corp Company Overview 133

5.35.1 Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 133

5.36 Biomedical Diagnostics Institute Company Overview 135

5.36.1 Biomedical Diagnostics Institute Pipeline Products & Ongoing Clinical Trials Overview 135

5.37 bioMerieux SA Company Overview 136

5.37.1 bioMerieux SA Pipeline Products & Ongoing Clinical Trials Overview 136

5.38 Biomolecular Determination SA Company Overview 137

5.38.1 Biomolecular Determination SA Pipeline Products & Ongoing Clinical Trials Overview 137

5.39 Biopromic AB Company Overview 140

5.39.1 Biopromic AB Pipeline Products & Ongoing Clinical Trials Overview 140

5.40 BiOracle Ltd (Inactive) Company Overview 141

5.40.1 BiOracle Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 141

5.41 Bio-Rad Laboratories Inc Company Overview 142

5.41.1 Bio-Rad Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 142

5.42 Biotech Consortium India Ltd Company Overview 143

5.42.1 Biotech Consortium India Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

5.43 Blaze Venture Technologies Limited Company Overview 144

5.43.1 Blaze Venture Technologies Limited Pipeline Products & Ongoing Clinical Trials Overview 144

5.44 Blue Comet Medical Solutions Company Overview 145

5.44.1 Blue Comet Medical Solutions Pipeline Products & Ongoing Clinical Trials Overview 145

5.45 Bluejay Diagnostics Inc Company Overview 146

5.45.1 Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 146

5.46 Boditech Med Inc Company Overview 147

5.46.1 Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 147

5.47 Bosch Healthcare Solutions GmbH Company Overview 152

5.47.1 Bosch Healthcare Solutions GmbH Pipeline Products & Ongoing Clinical Trials Overview 152

5.48 Boston University Company Overview 155

5.48.1 Boston University Pipeline Products & Ongoing Clinical Trials Overview 155

5.49 Brown University Company Overview 157

5.49.1 Brown University Pipeline Products & Ongoing Clinical Trials Overview 157

5.50 Bruker Daltonik GmbH Company Overview 158

5.50.1 Bruker Daltonik GmbH Pipeline Products & Ongoing Clinical Trials Overview 158

5.51 Burnet Institute Company Overview 159

5.51.1 Burnet Institute Pipeline Products & Ongoing Clinical Trials Overview 159

5.52 C4Diagnostics SAS Company Overview 161

5.52.1 C4Diagnostics SAS Pipeline Products & Ongoing Clinical Trials Overview 161

5.53 CAMPTON Diagnostics UG Company Overview 163

5.53.1 CAMPTON Diagnostics UG Pipeline Products & Ongoing Clinical Trials Overview 163

5.54 CAN Diagnostics Inc Company Overview 164

5.54.1 CAN Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 164

5.55 Carclo Diagnostic Solutions Ltd Company Overview 167

5.55.1 Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

5.56 Cardiff University Company Overview 168

5.56.1 Cardiff University Pipeline Products & Ongoing Clinical Trials Overview 168

5.57 CelerDx Inc Company Overview 170

5.57.1 CelerDx Inc Pipeline Products & Ongoing Clinical Trials Overview 170

5.58 Cellex Inc Company Overview 171

5.58.1 Cellex Inc Pipeline Products & Ongoing Clinical Trials Overview 171

5.59 Cepheid Inc Company Overview 172

5.59.1 Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 172

5.60 CFD Research Corp Company Overview 180

5.60.1 CFD Research Corp Pipeline Products & Ongoing Clinical Trials Overview 180

5.61 Charles University Company Overview 181

5.61.1 Charles University Pipeline Products & Ongoing Clinical Trials Overview 181

5.62 Checkable Medical Corp Company Overview 182

5.62.1 Checkable Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 182

5.63 Chembio Diagnostic Systems Inc Company Overview 185

5.63.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 185

5.64 Ciencia Company Overview 187

5.64.1 Ciencia Pipeline Products & Ongoing Clinical Trials Overview 187

5.65 Claremont BioSolutions Company Overview 188

5.65.1 Claremont BioSolutions Pipeline Products & Ongoing Clinical Trials Overview 188

5.66 CNine Biosolutions LLC Company Overview 189

5.66.1 CNine Biosolutions LLC Pipeline Products & Ongoing Clinical Trials Overview 189

5.67 Cobio Diagnostics Inc Company Overview 190

5.67.1 Cobio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 190

5.68 Co-Diagnostics Inc Company Overview 191

5.68.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 191

5.69 Colorado State University Company Overview 192

5.69.1 Colorado State University Pipeline Products & Ongoing Clinical Trials Overview 192

5.70 Contango Asset Management Ltd Company Overview 193

5.70.1 Contango Asset Management Ltd Pipeline Products & Ongoing Clinical Trials Overview 193

5.71 Cupid Ltd Company Overview 194

5.71.1 Cupid Ltd Pipeline Products & Ongoing Clinical Trials Overview 194

5.72 Curiosity Diagnostics Sp zoo Company Overview 195

5.72.1 Curiosity Diagnostics Sp zoo Pipeline Products & Ongoing Clinical Trials Overview 195

5.73 Day Zero Diagnostics Inc Company Overview 196

5.73.1 Day Zero Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 196

5.74 DCN Diagnostics Company Overview 197

5.74.1 DCN Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 197

5.75 Department of Biomedical Engineering Columbia University Company Overview 199

5.75.1 Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 199

5.76 DestiNA Genomica SL Company Overview 200

5.76.1 DestiNA Genomica SL Pipeline Products & Ongoing Clinical Trials Overview 200

5.77 Diafir Company Overview 201

5.77.1 Diafir Pipeline Products & Ongoing Clinical Trials Overview 201

5.78 Diagnostics For All Inc Company Overview 202

5.78.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 202

5.79 Diagnostics for the Real World (Europe) Ltd Company Overview 204

5.79.1 Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 204

5.80 DNAE Group Holdings Ltd Company Overview 205

5.80.1 DNAE Group Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 205

5.81 Domus Diagnostics Inc Company Overview 206

5.81.1 Domus Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 206

5.82 Duke University Company Overview 207

5.82.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 207

5.83 DxDiscovery Inc Company Overview 208

5.83.1 DxDiscovery Inc Pipeline Products & Ongoing Clinical Trials Overview 208

5.84 DxNA LLC Company Overview 213

5.84.1 DxNA LLC Pipeline Products & Ongoing Clinical Trials Overview 213

5.85 Dynasil Corporation of America Company Overview 214

5.85.1 Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview 214

5.86 ECI Biotech Inc. Company Overview 215

5.86.1 ECI Biotech Inc. Pipeline Products & Ongoing Clinical Trials Overview 215

5.87 Edan Instruments Inc Company Overview 216

5.87.1 Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 216

5.88 Ellume Ltd Company Overview 217

5.88.1 Ellume Ltd Pipeline Products & Ongoing Clinical Trials Overview 217

5.89 Elvesys Inc Company Overview 218

5.89.1 Elvesys Inc Pipeline Products & Ongoing Clinical Trials Overview 218

5.90 Embryyo Technologies Pvt Ltd Company Overview 219

5.90.1 Embryyo Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 219

5.91 EMPE Diagnostics AB Company Overview 220

5.91.1 EMPE Diagnostics AB Pipeline Products & Ongoing Clinical Trials Overview 220

5.92 Enigma Diagnostics Ltd (Inactive) Company Overview 221

5.92.1 Enigma Diagnostics Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 221

5.93 ENTvantage Dx Company Overview 222

5.93.1 ENTvantage Dx Pipeline Products & Ongoing Clinical Trials Overview 222

5.94 ERBA Molecular Ltd Company Overview 223

5.94.1 ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 223

5.95 Evolve Biosystems Inc Company Overview 226

5.95.1 Evolve Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 226

5.96 Fast Track Diagnostics Ltd Company Overview 227

5.96.1 Fast Track Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 227

5.97 First Light Diagnostics Inc Company Overview 229

5.97.1 First Light Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 229

5.98 FK-Biotecnologia SA Company Overview 232

5.98.1 FK-Biotecnologia SA Pipeline Products & Ongoing Clinical Trials Overview 232

5.99 Fluxergy LLC Company Overview 234

5.99.1 Fluxergy LLC Pipeline Products & Ongoing Clinical Trials Overview 234

5.100 Foundation for Innovative New Diagnostics Company Overview 235

5.100.1 Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 235

5.101 Fred Hutchinson Cancer Research Center Company Overview 236

5.101.1 Fred Hutchinson Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 236

5.102 Free University of Brussels Company Overview 237

5.102.1 Free University of Brussels Pipeline Products & Ongoing Clinical Trials Overview 237

5.103 Fyodor Biotechnologies, Inc. Company Overview 238

5.103.1 Fyodor Biotechnologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 238

5.104 GE Healthcare Company Overview 239

5.104.1 GE Healthcare Pipeline Products & Ongoing Clinical Trials Overview 239

5.105 GeneBio Systems Inc Company Overview 240

5.105.1 GeneBio Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 240

5.106 genedrive plc Company Overview 241

5.106.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 241

5.107 GeneEx, Inc (Inactive) Company Overview 244

5.107.1 GeneEx, Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 244

5.108 GenePOC Inc Company Overview 245

5.108.1 GenePOC Inc Pipeline Products & Ongoing Clinical Trials Overview 245

5.109 Genetic Signatures Ltd Company Overview 250

5.109.1 Genetic Signatures Ltd Pipeline Products & Ongoing Clinical Trials Overview 250

5.110 Global BioDiagnostics Corp. Company Overview 253

5.110.1 Global BioDiagnostics Corp. Pipeline Products & Ongoing Clinical Trials Overview 253

5.111 GNA Biosolutions GmbH Company Overview 255

5.111.1 GNA Biosolutions GmbH Pipeline Products & Ongoing Clinical Trials Overview 255

5.112 Goodgene Inc Company Overview 258

5.112.1 Goodgene Inc Pipeline Products & Ongoing Clinical Trials Overview 258

5.113 Gradientech AB Company Overview 259

5.113.1 Gradientech AB Pipeline Products & Ongoing Clinical Trials Overview 259

5.114 Great Basin Scientific Inc. Company Overview 260

5.114.1 Great Basin Scientific Inc. Pipeline Products & Ongoing Clinical Trials Overview 260

5.115 Group K Diagnostics Company Overview 261

5.115.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 261

5.116 Guanine Inc Company Overview 262

5.116.1 Guanine Inc Pipeline Products & Ongoing Clinical Trials Overview 262

5.117 Helixbind Inc Company Overview 264

5.117.1 Helixbind Inc Pipeline Products & Ongoing Clinical Trials Overview 264

5.118 HiberGene Diagnostics Ltd Company Overview 265

5.118.1 HiberGene Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 265

5.119 Hologic Inc Company Overview 268

5.119.1 Hologic Inc Pipeline Products & Ongoing Clinical Trials Overview 268

5.120 Hutman Diagnostics AG Company Overview 269

5.120.1 Hutman Diagnostics AG Pipeline Products & Ongoing Clinical Trials Overview 269

5.121 iCubate Inc Company Overview 271

5.121.1 iCubate Inc Pipeline Products & Ongoing Clinical Trials Overview 271

5.122 ID Genomics Inc Company Overview 273

5.122.1 ID Genomics Inc Pipeline Products & Ongoing Clinical Trials Overview 273

5.123 IdbyDNA Inc Company Overview 275

5.123.1 IdbyDNA Inc Pipeline Products & Ongoing Clinical Trials Overview 275

5.124 Identifysensors LLC Company Overview 276

5.124.1 Identifysensors LLC Pipeline Products & Ongoing Clinical Trials Overview 276

5.125 IDL Biotech AB Company Overview 277

5.125.1 IDL Biotech AB Pipeline Products & Ongoing Clinical Trials Overview 277

5.126 Illucidx Inc Company Overview 280

5.126.1 Illucidx Inc Pipeline Products & Ongoing Clinical Trials Overview 280

5.127 ImevaX GmbH Company Overview 282

5.127.1 ImevaX GmbH Pipeline Products & Ongoing Clinical Trials Overview 282

5.128 ImmuneMed Inc Company Overview 283

5.128.1 ImmuneMed Inc Pipeline Products & Ongoing Clinical Trials Overview 283

5.129 Immunetics Inc Company Overview 285

5.129.1 Immunetics Inc Pipeline Products & Ongoing Clinical Trials Overview 285

5.130 Immunexpress Pty Ltd Company Overview 286

5.130.1 Immunexpress Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 286

5.131 Immuno Technologies Inc Company Overview 289

5.131.1 Immuno Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 289

5.132 ImmunoScience Inc Company Overview 290

5.132.1 ImmunoScience Inc Pipeline Products & Ongoing Clinical Trials Overview 290

5.133 Imperial College London Company Overview 292

5.133.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 292

5.134 InBios International Inc Company Overview 294

5.134.1 InBios International Inc Pipeline Products & Ongoing Clinical Trials Overview 294

5.135 Innatoss Laboratories BV Company Overview 295

5.135.1 Innatoss Laboratories BV Pipeline Products & Ongoing Clinical Trials Overview 295

5.136 Innova Biotechnology Co Ltd Company Overview 296

5.136.1 Innova Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 296

5.137 Innova Medical Group Inc Company Overview 298

5.137.1 Innova Medical Group Inc Pipeline Products & Ongoing Clinical Trials Overview 298

5.138 Insilixa, Inc. Company Overview 299

5.138.1 Insilixa, Inc. Pipeline Products & Ongoing Clinical Trials Overview 299

5.139 Institute for Development Research Company Overview 302

5.139.1 Institute for Development Research Pipeline Products & Ongoing Clinical Trials Overview 302

5.140 Institute of Molecular Biology of Parana Company Overview 303

5.140.1 Institute of Molecular Biology of Parana Pipeline Products & Ongoing Clinical Trials Overview 303

5.141 JAJ International Inc Company Overview 304

5.141.1 JAJ International Inc Pipeline Products & Ongoing Clinical Trials Overview 304

5.142 Johns Hopkins University Company Overview 305

5.142.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 305

5.143 Kaneka Corp Company Overview 309

5.143.1 Kaneka Corp Pipeline Products & Ongoing Clinical Trials Overview 309

5.144 Kenta Biotech Ltd Company Overview 310

5.144.1 Kenta Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 310

5.145 Kephera Diagnostics LLC Company Overview 311

5.145.1 Kephera Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 311

5.146 Leiden University Medical Center Company Overview 312

5.146.1 Leiden University Medical Center Pipeline Products & Ongoing Clinical Trials Overview 312

5.147 Lenima Field Diagnostics LLC Company Overview 313

5.147.1 Lenima Field Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 313

5.148 Lexagene Holdings Inc Company Overview 315

5.148.1 Lexagene Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 315

5.149 LightDeck Diagnostics Inc Company Overview 317

5.149.1 LightDeck Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 317

5.150 Loop Dx Company Overview 319

5.150.1 Loop Dx Pipeline Products & Ongoing Clinical Trials Overview 319

5.151 LPS-BioSciences Company Overview 320

5.151.1 LPS-BioSciences Pipeline Products & Ongoing Clinical Trials Overview 320

5.152 Lucigen Corp Company Overview 321

5.152.1 Lucigen Corp Pipeline Products & Ongoing Clinical Trials Overview 321

5.153 Lucira Health Inc Company Overview 323

5.153.1 Lucira Health Inc Pipeline Products & Ongoing Clinical Trials Overview 323

5.154 Luminostics Inc Company Overview 326

5.154.1 Luminostics Inc Pipeline Products & Ongoing Clinical Trials Overview 326

5.155 LumiraDx Ltd Company Overview 328

5.155.1 LumiraDx Ltd Pipeline Products & Ongoing Clinical Trials Overview 328

5.156 Lynntech Inc Company Overview 329

5.156.1 Lynntech Inc Pipeline Products & Ongoing Clinical Trials Overview 329

5.157 March of Dimes Foundation Company Overview 330

5.157.1 March of Dimes Foundation Pipeline Products & Ongoing Clinical Trials Overview 330

5.158 Massachusetts General Hospital Company Overview 332

5.158.1 Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 332

5.159 Medical Research Council Company Overview 334

5.159.1 Medical Research Council Pipeline Products & Ongoing Clinical Trials Overview 334

5.160 Medical Research Council Unit The Gambia Company Overview 335

5.160.1 Medical Research Council Unit The Gambia Pipeline Products & Ongoing Clinical Trials Overview 335

5.161 MedMira Inc Company Overview 338

5.161.1 MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 338

5.162 Meridian Bioscience Inc Company Overview 339

5.162.1 Meridian Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 339

5.163 Mesa Tech International, Inc. Company Overview 341

5.163.1 Mesa Tech International, Inc. Pipeline Products & Ongoing Clinical Trials Overview 341

5.164 Metropolis Healthcare Ltd Company Overview 342

5.164.1 Metropolis Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 342

5.165 Micronics Inc Company Overview 343

5.165.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 343

5.166 Molbio Diagnostics Pvt Ltd Company Overview 346

5.166.1 Molbio Diagnostics Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 346

5.167 Molnlycke Health Care AB Company Overview 358

5.167.1 Molnlycke Health Care AB Pipeline Products & Ongoing Clinical Trials Overview 358

5.168 MyMD Pharmaceuticals, Inc Company Overview 359

5.168.1 MyMD Pharmaceuticals, Inc Pipeline Products & Ongoing Clinical Trials Overview 359

5.169 Nal Von Minden GmbH Company Overview 360

5.169.1 Nal Von Minden GmbH Pipeline Products & Ongoing Clinical Trials Overview 360

5.170 Nanodetection Technology Inc Company Overview 361

5.170.1 Nanodetection Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 361

5.171 Nanopore Diagnostics, LLC Company Overview 364

5.171.1 Nanopore Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 364

5.172 NanoRepro AG Company Overview 365

5.172.1 NanoRepro AG Pipeline Products & Ongoing Clinical Trials Overview 365

5.173 Nemis Technologies AG Company Overview 368

5.173.1 Nemis Technologies AG Pipeline Products & Ongoing Clinical Trials Overview 368

5.174 NetBio, Inc. Company Overview 376

5.174.1 NetBio, Inc. Pipeline Products & Ongoing Clinical Trials Overview 376

5.175 Northwestern University Company Overview 378

5.175.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 378

5.176 NOWDiagnostics Inc Company Overview 379

5.176.1 NOWDiagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 379

5.177 NuGenerex Diagnostics LLC Company Overview 382

5.177.1 NuGenerex Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 382

5.178 Omega Diagnostics Group Plc Company Overview 385

5.178.1 Omega Diagnostics Group Plc Pipeline Products & Ongoing Clinical Trials Overview 385

5.179 One BioMed Pte Ltd Company Overview 386

5.179.1 One BioMed Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 386

5.180 Ontera Inc Company Overview 387

5.180.1 Ontera Inc Pipeline Products & Ongoing Clinical Trials Overview 387

5.181 OpGen Inc Company Overview 388

5.181.1 OpGen Inc Pipeline Products & Ongoing Clinical Trials Overview 388

5.182 OPKO Health Inc Company Overview 389

5.182.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 389

5.183 OptiCul Diagnostics Ltd. Company Overview 390

5.183.1 OptiCul Diagnostics Ltd. Pipeline Products & Ongoing Clinical Trials Overview 390

5.184 Osaka University Company Overview 391

5.184.1 Osaka University Pipeline Products & Ongoing Clinical Trials Overview 391

5.185 Pamlico Biopharma Inc Company Overview 392

5.185.1 Pamlico Biopharma Inc Pipeline Products & Ongoing Clinical Trials Overview 392

5.186 Pattern Bioscience Inc Company Overview 393

5.186.1 Pattern Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 393

5.187 PBD Biotech Ltd Company Overview 394

5.187.1 PBD Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 394

5.188 Philips Healthcare Company Overview 395

5.188.1 Philips Healthcare Pipeline Products & Ongoing Clinical Trials Overview 395

5.189 Phoenix Biosystems Inc Company Overview 396

5.189.1 Phoenix Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 396

5.190 Photon Biosciences LLC Company Overview 397

5.190.1 Photon Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 397

5.191 PreDxion Bio Inc Company Overview 398

5.191.1 PreDxion Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 398

5.192 Prime Discoveries Inc Company Overview 399

5.192.1 Prime Discoveries Inc Pipeline Products & Ongoing Clinical Trials Overview 399

5.193 PriTest Inc. Company Overview 402

5.193.1 PriTest Inc. Pipeline Products & Ongoing Clinical Trials Overview 402

5.194 Prominex Inc Company Overview 403

5.194.1 Prominex Inc Pipeline Products & Ongoing Clinical Trials Overview 403

5.195 ProteinLogic Ltd Company Overview 406

5.195.1 ProteinLogic Ltd Pipeline Products & Ongoing Clinical Trials Overview 406

5.196 Proxim Diagnostics Corp Company Overview 407

5.196.1 Proxim Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 407

5.197 Qiagen NV Company Overview 409

5.197.1 Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 409

5.198 Qorvo Biotechnologies LLC Company Overview 412

5.198.1 Qorvo Biotechnologies LLC Pipeline Products & Ongoing Clinical Trials Overview 412

5.199 QSM Diagnostics Inc Company Overview 413

5.199.1 QSM Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 413

5.200 QuantaLife Inc (Inactive) Company Overview 414

5.200.1 QuantaLife Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 414

5.201 Quanterix Corp Company Overview 415

5.201.1 Quanterix Corp Pipeline Products & Ongoing Clinical Trials Overview 415

5.202 QuantuMDx Group Ltd Company Overview 416

5.202.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 416

5.203 QuickCheck Health Inc Company Overview 419

5.203.1 QuickCheck Health Inc Pipeline Products & Ongoing Clinical Trials Overview 419

5.204 Quidel Corp Company Overview 421

5.204.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 421

5.205 Quintain NanoSystems (Inactive) Company Overview 434

5.205.1 Quintain NanoSystems (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 434

5.206 Randox Laboratories Ltd Company Overview 435

5.206.1 Randox Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 435

5.207 Rapid Diagnostic Pvt Ltd Company Overview 436

5.207.1 Rapid Diagnostic Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 436

5.208 RNA Disease Diagnostics Inc Company Overview 437

5.208.1 RNA Disease Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 437

5.209 Rockefeller University Company Overview 440

5.209.1 Rockefeller University Pipeline Products & Ongoing Clinical Trials Overview 440

5.210 Rutgers Biomedical and Health Sciences Company Overview 441

5.210.1 Rutgers Biomedical and Health Sciences Pipeline Products & Ongoing Clinical Trials Overview 441

5.211 Rutgers New Jersey Medical School Company Overview 443

5.211.1 Rutgers New Jersey Medical School Pipeline Products & Ongoing Clinical Trials Overview 443

5.212 Salus Discovery LLC Company Overview 444

5.212.1 Salus Discovery LLC Pipeline Products & Ongoing Clinical Trials Overview 444

5.213 Saureus, Inc. Company Overview 445

5.213.1 Saureus, Inc. Pipeline Products & Ongoing Clinical Trials Overview 445

5.214 Scanogen Inc Company Overview 447

5.214.1 Scanogen Inc Pipeline Products & Ongoing Clinical Trials Overview 447

5.215 Selfdiagnostics OU Company Overview 448

5.215.1 Selfdiagnostics OU Pipeline Products & Ongoing Clinical Trials Overview 448

5.216 SensDx SA Company Overview 452

5.216.1 SensDx SA Pipeline Products & Ongoing Clinical Trials Overview 452

5.217 Senzo Inc Company Overview 455

5.217.1 Senzo Inc Pipeline Products & Ongoing Clinical Trials Overview 455

5.218 SeroSelectTB Company Overview 458

5.218.1 SeroSelectTB Pipeline Products & Ongoing Clinical Trials Overview 458

5.219 SLS Cell Cure Technologies Pty Ltd Company Overview 461

5.219.1 SLS Cell Cure Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 461

5.220 Smiths Detection Inc Company Overview 464

5.220.1 Smiths Detection Inc Pipeline Products & Ongoing Clinical Trials Overview 464

5.221 Spanish National Research Council Company Overview 466

5.221.1 Spanish National Research Council Pipeline Products & Ongoing Clinical Trials Overview 466

5.222 Sphingotec GmbH Company Overview 467

5.222.1 Sphingotec GmbH Pipeline Products & Ongoing Clinical Trials Overview 467

5.223 SpinDiag GmbH Company Overview 468

5.223.1 SpinDiag GmbH Pipeline Products & Ongoing Clinical Trials Overview 468

5.224 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 470

5.224.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 470

5.225 Sri Narayani Hospital & Research Center Company Overview 473

5.225.1 Sri Narayani Hospital & Research Center Pipeline Products & Ongoing Clinical Trials Overview 473

5.226 Stanford University Company Overview 474

5.226.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 474

5.227 Stellar Diagnostics India Pvt Ltd Company Overview 475

5.227.1 Stellar Diagnostics India Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 475

5.228 T2 Biosystems Inc Company Overview 476

5.228.1 T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 476

5.229 Talis Biomedical Corp Company Overview 485

5.229.1 Talis Biomedical Corp Pipeline Products & Ongoing Clinical Trials Overview 485

5.230 Tangen Biosciences Inc Company Overview 489

5.230.1 Tangen Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 489

5.231 TB Biosciences, Inc. Company Overview 491

5.231.1 TB Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 491

5.232 Technical University of Munich Company Overview 493

5.232.1 Technical University of Munich Pipeline Products & Ongoing Clinical Trials Overview 493

5.233 The Forsyth Institute Company Overview 494

5.233.1 The Forsyth Institute Pipeline Products & Ongoing Clinical Trials Overview 494

5.234 The Translational Genomics Research Institute Company Overview 495

5.234.1 The Translational Genomics Research Institute Pipeline Products & Ongoing Clinical Trials Overview 495

5.235 Thermo Fisher Scientific Inc Company Overview 496

5.235.1 Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 496

5.236 ThreeFold Sensors (Inactive) Company Overview 497

5.236.1 ThreeFold Sensors (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 497

5.237 Trinity Biotech Plc Company

Table

Bacteriology Rapid Tests & POC – Pipeline Products by Stage of Development 40

Bacteriology Rapid Tests & POC – Pipeline Products by Segment 41

Bacteriology Rapid Tests & POC – Pipeline Products by Territory 42

Bacteriology Rapid Tests & POC – Pipeline Products by Regulatory Path 44

Bacteriology Rapid Tests & POC – Pipeline Products by Estimated Approval Date 45

Bacteriology Rapid Tests & POC – Ongoing Clinical Trials 46

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

Bacteriology Rapid Tests & POC – Pipeline Products by Stage of Development 57

Abacus Diagnostica Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

GenomEra CTX-M Assay – Product Status 69

GenomEra CTX-M Assay – Product Description 70

GenomEra Enterococcus Faecalis Assay – Product Status 70

GenomEra Enterococcus Faecalis Assay – Product Description 70

GenomEra Enterococcus Faecium Assay – Product Status 71

GenomEra Enterococcus Faecium Assay – Product Description 71

GenomEra Escherichia Coli Assay – Product Status 71

GenomEra Escherichia Coli Assay – Product Description 72

GenomEra Klebsiella Pneumoniae Assay – Product Status 72

GenomEra Klebsiella Pneumoniae Assay – Product Description 72

GenomEra KPC Assay – Product Status 73

GenomEra KPC Assay – Product Description 73

GenomEra NDM Assay – Product Status 73

GenomEra NDM Assay – Product Description 74

GenomEra Pseudomonas Aeruginosa Assay – Product Status 74

GenomEra Pseudomonas Aeruginosa Assay – Product Description 74

GenomEra VRE – vanA Assay – Product Status 75

GenomEra VRE – vanA Assay – Product Description 75

GenomEra VRE – vanB Assay – Product Status 75

GenomEra VRE – vanB Assay – Product Description 76

Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 77

PLEX-ID – Orthopedic Infection Rapid Assay – Product Status 77

PLEX-ID – Orthopedic Infection Rapid Assay – Product Description 77

Accel Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 78

pScreen-Sep – Product Status 78

pScreen-Sep – Product Description 78

Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 79

ICT – Scrub Typhus IgM RDT – Product Status 79

ICT – Scrub Typhus IgM RDT – Product Description 79

Rosus – Chlamydia TRF – Product Status 80

Rosus – Chlamydia TRF – Product Description 80

Access to Advanced Health Institute Pipeline Products & Ongoing Clinical Trials Overview 81

Rapid Diagnostic Test – Leprosy – Product Status 81

Rapid Diagnostic Test – Leprosy – Product Description 81

Adaptive Phage Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 82

PhageBank Susceptibility Test – Product Status 82

PhageBank Susceptibility Test – Product Description 82

Adaptive Phage Therapeutics Inc – Ongoing Clinical Trials Overview 83

PhageBank Susceptibility Test – A Phase I/II Study of Bacteriophage Therapy to Evaluate Safety, Tolerability, and Efficacy of Targeted “Personalized” Bacteriophage Treatments in Patients with Bacterial Infection of the Urinary Tract 84

Adnavance Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 85

M-DNA Molecular Diagnostic Kit – Product Status 85

M-DNA Molecular Diagnostic Kit – Product Description 85

Advanced Liquid Logic Inc Pipeline Products & Ongoing Clinical Trials Overview 86

MRSA Screening Test – Product Status 86

MRSA Screening Test – Product Description 86

AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 87

Agilis Reader – HNL Assay – Product Status 87

Agilis Reader – HNL Assay – Product Description 87

AI Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88

Point Of Care Assay – Gonorrhea – Product Status 88

Point Of Care Assay – Gonorrhea – Product Description 88

Aidian Oy Pipeline Products & Ongoing Clinical Trials Overview 89

Orion GenRead – Salmonella Assay – Product Status 89

Orion GenRead – Salmonella Assay – Product Description 89

Akonni Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 90

TruArray MDR – TB Test Kit – Product Status 90

TruArray MDR – TB Test Kit – Product Description 90

TruArray MRSA Assay – Product Status 91

TruArray MRSA Assay – Product Description 91

Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Alere q Analyzer – Tuberculosis Assay – Product Status 92

Alere q Analyzer – Tuberculosis Assay – Product Description 92

ID NOW – B.Pertussis Assay – Product Status 93

ID NOW – B.Pertussis Assay – Product Description 93

ID NOW – CT/GC Assay – Product Status 93

ID NOW – CT/GC Assay – Product Description 94

ID NOW – GBS Assay – Product Status 94

ID NOW – GBS Assay – Product Description 94

ID NOW – M.P/C.P Assay – Product Status 95

ID NOW – M.P/C.P Assay – Product Description 95

ID NOW – MRSA Assay – Product Status 95

ID NOW – MRSA Assay – Product Description 96

NEAR Assay – Tuberculosis – Product Status 96

NEAR Assay – Tuberculosis – Product Description 96

All India Institute of Medical Sciences Pipeline Products & Ongoing Clinical Trials Overview 97

Aptamer Based Point Of Care Test – N. Gonorrhoeae – Product Status 97

Aptamer Based Point Of Care Test – N. Gonorrhoeae – Product Description 97

Point Of Care Disposable Senor Strip – Tuberculosis – Product Status 98

Point Of Care Disposable Senor Strip – Tuberculosis – Product Description 98

Angle Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 99

ALENA System – Abscesses – Product Status 99

ALENA System – Abscesses – Product Description 99

ALENA System – Sepsis – Product Status 100

ALENA System – Sepsis – Product Description 100

Applied Nanodetectors Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

Real Time Point Of Care Test – TB – Product Status 101

Real Time Point Of Care Test – TB – Product Description 101

Arbor Vita Corp Pipeline Products & Ongoing Clinical Trials Overview 102

OncoE6 Assay – CT – Product Status 102

OncoE6 Assay – CT – Product Description 102

OncoE6 Assay – CT/NG – Product Status 103

OncoE6 Assay – CT/NG – Product Description 103

OncoE6 Assay – NG – Product Status 103

OncoE6 Assay – NG – Product Description 104

OncoE6 Assay – TV – Product Status 104

OncoE6 Assay – TV – Product Description 104

Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 105

Nanodisk-MS Assay – Product Status 105

Nanodisk-MS Assay – Product Description 105

Attoplex Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

Rapid Gene Amplification Home Test – Food Poisoning – Product Status 106

Rapid Gene Amplification Home Test – Food Poisoning – Product Description 106

Avacta Group Plc Pipeline Products & Ongoing Clinical Trials Overview 107

Rapid Diagnostic Test – Bacterial Strains – Product Status 107

Rapid Diagnostic Test – Bacterial Strains – Product Description 107

Avesthagen Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

Diagnostic Test – Tuberculosis – Product Status 108

Diagnostic Test – Tuberculosis – Product Description 108

B&W Tek Inc Pipeline Products & Ongoing Clinical Trials Overview 109

Point-Of-Care Test – Tuberculosis – Product Status 109

Point-Of-Care Test – Tuberculosis – Product Description 109

BATM Advanced Communications Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

NATlab System – TB – Product Status 110

NATlab System – TB – Product Description 110

BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 111

Mobile RDT Reader – Gonorrhea Test – Product Status 111

Mobile RDT Reader – Gonorrhea Test – Product Description 111

Mobile RDT Reader – Syphilis Test – Product Status 112

Mobile RDT Reader – Syphilis Test – Product Description 112

Mobile RDT Reader – Tuberculosis Test – Product Status 112

Mobile RDT Reader – Tuberculosis Test – Product Description 113

Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 114

BD Veritor At-Home Strep Test – Product Status 114

BD Veritor At-Home Strep Test – Product Description 114

Binx Health Inc Pipeline Products & Ongoing Clinical Trials Overview 115

Atlas io Cartridge – MSSA Assay – Product Status 115

Atlas io Cartridge – MSSA Assay – Product Description 116

Atlas io System – Bacterial Meningitis Assay – Product Status 116

Atlas io System – Bacterial Meningitis Assay – Product Description 116

Atlas io System – Group A Streptococcus Assay – Product Status 117

Atlas io System – Group A Streptococcus Assay – Product Description 117

Atlas io System – Group B Streptococcus Assay – Product Status 117

Atlas io System – Group B Streptococcus Assay – Product Description 118

Atlas io System – MRSA Assay – Product Status 118

Atlas io System – MRSA Assay – Product Description 118

Atlas io System – Sepsis – Product Status 119

Atlas io System – Sepsis – Product Description 119

Atlas Syphilis Anti-Treponemal Antibody Test (IgG & IgM) – Product Status 119

Atlas Syphilis Anti-Treponemal Antibody Test (IgG & IgM) – Product Description 120

io MG+R Test – Product Status 120

io MG+R Test – Product Description 120

io mSTI+ Assay – Product Status 121

io mSTI+ Assay – Product Description 121

io NG+R Test – Product Status 122

io NG+R Test – Product Description 122

Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 123

Digital Strip Reader – Chlamydia Test – Product Status 123

Digital Strip Reader – Chlamydia Test – Product Description 123

BioAssay Works, LLC Pipeline Products & Ongoing Clinical Trials Overview 124

Diagnostic Assay – Staph Aureus – Product Status 124

Diagnostic Assay – Staph Aureus – Product Description 124

BioDesign Institute at Arizona State University Pipeline Products & Ongoing Clinical Trials Overview 125

Biomarker Test – Tuberculosis – Product Status 125

Biomarker Test – Tuberculosis – Product Description 125

BioDetection Instruments, LLC Pipeline Products & Ongoing Clinical Trials Overview 126

MRSA/MSSA Molecular Test – Product Status 126

MRSA/MSSA Molecular Test – Product Description 126

BioFire Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 127

FilmArray Sepsis Direct Panel – Product Status 127

FilmArray Sepsis Direct Panel – Product Description 127

Biogenes Technologies Sdn Bhd Pipeline Products & Ongoing Clinical Trials Overview 128

Ultralab – Sepsis Assay – Product Status 128

Ultralab – Sepsis Assay – Product Description 128

Ultralab – Streptococcus Infection Assay – Product Status 129

Ultralab – Streptococcus Infection Assay – Product Description 129

Ultralab – Tuberculosis Assay – Product Status 129

Ultralab – Tuberculosis Assay – Product Description 130

Biogenix Inc Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

Rapid Procalcitonin Detection Kit – Chlamydia trachomatis – Product Status 131

Rapid Procalcitonin Detection Kit – Chlamydia trachomatis – Product Description 131

Rapid Procalcitonin Detection Kit – Sepsis – Product Status 132

Rapid Procalcitonin Detection Kit – Sepsis – Product Description 132

Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 133

IOBS – Cholera Diagnostic Test – Product Status 133

IOBS – Cholera Diagnostic Test – Product Description 133

IOBS – Tuberculosis Diagnostic Test – Product Status 134

IOBS – Tuberculosis Diagnostic Test – Product Description 134

Biomedical Diagnostics Institute Pipeline Products & Ongoing Clinical Trials Overview 135

Nucleic-acid Based Diagnostic Test – Product Status 135

Nucleic-acid Based Diagnostic Test – Product Description 135

bioMerieux SA Pipeline Products & Ongoing Clinical Trials Overview 136

Diagnostic Test – Tuberculosis – Product Status 136

Diagnostic Test – Tuberculosis – Product Description 136

Biomolecular Determination SA Pipeline Products & Ongoing Clinical Trials Overview 137

Probe4Campylobacter – Product Status 137

Probe4Campylobacter – Product Description 137

Probe4Ec0157 – Product Status 138

Probe4Ec0157 – Product Description 138

Probe4Vibrio – Product Status 138

Probe4Vibrio – Product Description 139

Biopromic AB Pipeline Products & Ongoing Clinical Trials Overview 140

Ultra Sensitive TB LAM Assay – Product Status 140

Ultra Sensitive TB LAM Assay – Product Description 140

BiOracle Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 141

bio1039 Diagnostic Test – Product Status 141

bio1039 Diagnostic Test – Product Description 141

Bio-Rad Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 142

Droplet Digital PCR – MRSA Infection – Product Status 142

Droplet Digital PCR – MRSA Infection – Product Description 142

Biotech Consortium India Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

Dot Blot Assay Kit – Chlamydia Infections – Product Status 143

Dot Blot Assay Kit – Chlamydia Infections – Product Description 143

Blaze Venture Technologies Limited Pipeline Products & Ongoing Clinical Trials Overview 144

Diagnostic Assay – MRSA – Product Status 144

Diagnostic Assay – MRSA – Product Description 144

Blue Comet Medical Solutions Pipeline Products & Ongoing Clinical Trials Overview 145

Blue Comet Home Strep Test – Product Status 145

Blue Comet Home Strep Test – Product Description 145

Bluejay Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 146

Lyme Disease POC Test – Product Status 146

Lyme Disease POC Test – Product Description 146

Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 147

Ichroma – 50 – Mycoplasma Assay – Product Status 147

Ichroma – 50 – Mycoplasma Assay – Product Description 148

Ichroma 10 – IGRA-TB – Product Status 148

Ichroma 10 – IGRA-TB – Product Description 148

Ichroma II – IGRA-TB – Product Status 149

Ichroma II – IGRA-TB – Product Description 149

Ichroma II – Mycoplasma Assay – Product Status 149

Ichroma II – Mycoplasma Assay – Product Description 150

Ichroma III – IGRA-TB – Product Status 150

Ichroma III – IGRA-TB – Product Description 150

Ichroma M2 – Mycoplasma Assay – Product Status 151

Ichroma M2 – Mycoplasma Assay – Product Description 151

Bosch Healthcare Solutions GmbH Pipeline Products & Ongoing Clinical Trials Overview 152

Vivalytic – CT – Product Status 152

Vivalytic – CT – Product Description 152

Vivalytic – MRSA Test – Product Status 153

Vivalytic – MRSA Test – Product Description 153

Vivalytic – NG – Product Status 153

Vivalytic – NG – Product Description 154

Vivalytic – UTI Panel – Product Status 154

Vivalytic – UTI Panel – Product Description 154

Boston University Pipeline Products & Ongoing Clinical Trials Overview 155

Diagnostic Test – Bordetella Pertussis – Product Status 155

Diagnostic Test – Bordetella Pertussis – Product Description 155

LAM Based Test – Tuberculosis – Product Status 156

LAM Based Test – Tuberculosis – Product Description 156

Brown University Pipeline Products & Ongoing Clinical Trials Overview 157

Rapid Test – Clostridium Difficile Infection – Product Status 157

Rapid Test – Clostridium Difficile Infection – Product Description 157

Bruker Daltonik GmbH Pipeline Products & Ongoing Clinical Trials Overview 158

MALDI Biotyper – Bacterial Infection – Product Status 158

MALDI Biotyper – Bacterial Infection – Product Description 158

Burnet Institute Pipeline Products & Ongoing Clinical Trials Overview 159

POC Diagnostic Test – Neonatal Sepsis – Product Status 159

POC Diagnostic Test – Neonatal Sepsis – Product Description 159

Salmonella POC Diagnostic Test – Product Status 160

Salmonella POC Diagnostic Test – Product Description 160

C4Diagnostics SAS Pipeline Products & Ongoing Clinical Trials Overview 161

Legionella Pneumophila Detection Kit – Product Status 161

Legionella Pneumophila Detection Kit – Product Description 161

Legionnaires’ Disease Detection Kit v2 – Product Status 162

Legionnaires’ Disease Detection Kit v2 – Product Description 162

CAMPTON Diagnostics UG Pipeline Products & Ongoing Clinical Trials Overview 163

Diagnostic Assay – MRSA – Product Status 163

Diagnostic Assay – MRSA – Product Description 163

CAN Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 164

CNA Rapid Sepsis DX Assay – Product Status 164

CNA Rapid Sepsis DX Assay – Product Description 164

CAN Diagnostics Inc – Ongoing Clinical Trials Overview 165

CNA Rapid Sepsis DX Assay – Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness (Pre-SEPSIS Trial) 166

Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

Micropoc-CAT – CRP Assay – Product Status 167

Micropoc-CAT – CRP Assay – Product Description 167

Cardiff University Pipeline Products & Ongoing Clinical Trials Overview 168

Diagnostic Test – Bowel Cancer – Product Status 168

Diagnostic Test – Bowel Cancer – Product Description 168

Rapid Diagnostic Test – Sepsis – Product Status 169

Rapid Diagnostic Test – Sepsis – Product Description 169

CelerDx Inc Pipeline Products & Ongoing Clinical Trials Overview 170

Serological Test – Bacterial Infection/Antibiotic Senstivity – Product Status 170

Serological Test – Bacterial Infection/Antibiotic Senstivity – Product Description 170

Cellex Inc Pipeline Products & Ongoing Clinical Trials Overview 171

qCPO Test – Product Status 171

qCPO Test – Product Description 171

Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 172

GeneXpert Omni – MTB/RIF – Product Status 172

GeneXpert Omni – MTB/RIF – Product Description 172

GeneXpert Omni – Xpert CT/NG – Product Status 173

GeneXpert Omni – Xpert CT/NG – Product Description 173

GeneXpert Omni – Xpert MTB/RIF Ultra – Product Status 173

GeneXpert Omni – Xpert MTB/RIF Ultra – Product Description 174

GeneXpert Omni – Xpress CT/NG CW – Product Status 174

GeneXpert Omni – Xpress CT/NG CW – Product Description 174

GeneXpert Omni – Xpress GAS CW – Product Status 175

GeneXpert Omni – Xpress GAS CW – Product Description 175

GeneXpert Omni – Xpress GBS Ultra CW – Product Status 175

GeneXpert Omni – Xpress GBS Ultra CW – Product Description 176

GeneXpert Omni – Xpress Pertussis CW – Product Status 176

GeneXpert Omni – Xpress Pertussis CW – Product Description 176

Cepheid Inc – Ongoing Clinical Trials Overview 177

GeneXpert Omni – Xpert MTB/RIF Ultra – Cepheid GeneXpert Omni combined with the Xpert MTB/RIF Ultra for Detection of Tuberculosis and Rifampicin Resistance in Adults with Presumptive Pulmonary Tuberculosis at Primary-level Diagnostic Centers in Tanzania: A Pragmatic, Cluster-randomized Controlled Trial: Omni/Ultra Trial 178

GeneXpert Omni – Xpert MTB/RIF Ultra – Cepheid GeneXpertOmni Combined with the Xpert MTB/RIF Ultra (Omni/Ultra) for Detection of Tuberculosis and Rifampicin Resistance in Adults with Presumptive Pulmonary Tuberculosis at Primary-level Diagnostic Centres in Tanzania and Mozambique: a Pragmatic, Cluster-randomized Controlled Trial 178

GeneXpert Omni – Xpert MTB/RIF Ultra – Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB 178

GeneXpert Omni – MTB/RIF – Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB 179

GeneXpert Omni – MTB/RIF – Prevalence and Burden of Bronchiectasis in Tuberculous Patients 179

CFD Research Corp Pipeline Products & Ongoing Clinical Trials Overview 180

PredictSEP – Product Status 180

PredictSEP – Product Description 180

Charles University Pipeline Products & Ongoing Clinical Trials Overview 181

Diagnostic Assay – Antibiotic Resistance – Product Status 181

Diagnostic Assay – Antibiotic Resistance – Product Description 181

Checkable Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 182

At-Home Rapid Strep Test – Product Status 182

At-Home Rapid Strep Test – Product Description 182

Checkable Medical Corp – Ongoing Clinical Trials Overview 183

At-Home Rapid Strep Test – A Clinical Study to Evaluate the Efficacy of Checkable’s At-Home Strep Throat Test Kit in Strep Throat Patients 184

Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 185

DPP Leptospirosis Test – Product Status 185

DPP Leptospirosis Test – Product Description 185

DPP Tuberculosis Assay – Product Status 186

DPP Tuberculosis Assay – Product Description 186

Ciencia Pipeline Products & Ongoing Clinical Trials Overview 187

Fluorescent Plasmonic Biochip Assay – Tickborne Disease – Product Status 187

Fluorescent Plasmonic Biochip Assay – Tickborne Disease – Product Description 187

Claremont BioSolutions Pipeline Products & Ongoing Clinical Trials Overview 188

Diagnostic Assay – Multi-Drug Resistant Tuberculosis – Product Status 188

Diagnostic Assay – Multi-Drug Resistant Tuberculosis – Product Description 188

CNine Biosolutions LLC Pipeline Products & Ongoing Clinical Trials Overview 189

Lateral Flow Assay – Bacterial Meningitis – Product Status 189

Lateral Flow Assay – Bacterial Meningitis – Product Description 189

Cobio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 190

PhAAST-MIC – Product Status 190

PhAAST-MIC – Product Description 190

Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 191

Diagnostic Test – Drug Resistant Tuberculosis – Product Status 191

Diagnostic Test – Drug Resistant Tuberculosis – Product Description 191

Colorado State University Pipeline Products & Ongoing Clinical Trials Overview 192

POC Diagnostic Test – Tuberculosis – Product Status 192

POC Diagnostic Test – Tuberculosis – Product Description 192

Contango Asset Management Ltd Pipeline Products & Ongoing Clinical Trials Overview 193

Second Generation TB POC Test – Product Status 193

Second Generation TB POC Test – Product Description 193

Cupid Ltd Pipeline Products & Ongoing Clinical Trials Overview 194

Typhoid RDT Test – Product Status 194

Typhoid RDT Test – Product Description 194

Curiosity Diagnostics Sp zoo Pipeline Products & Ongoing Clinical Trials Overview 195

PCR|ONE System – Clostridium Panel – Product Status 195

PCR|ONE System – Clostridium Panel – Product Description 195

Day Zero Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 196

Diagnostic Test – Bacterial Infections – Product Status 196

Diagnostic Test – Bacterial Infections – Product Description 196

DCN Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 197

Point Of Care Blood Test – Anthrax – Product Status 197

Point Of Care Blood Test – Anthrax – Product Description 197

Rapid Lateral Flow Assay – Gonorrhoea – Product Status 198

Rapid Lateral Flow Assay – Gonorrhoea – Product Description 198

Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 199

Point-Of-Care Test – MRSA – Product Status 199

Point-Of-Care Test – MRSA – Product Description 199

DestiNA Genomica SL Pipeline Products & Ongoing Clinical Trials Overview 200

Diagnostic Test – Tuberculosis – Product Status 200

Diagnostic Test – Tuberculosis – Product Description 200

Diafir Pipeline Products & Ongoing Clinical Trials Overview 201

Ascites Spontaneous Peritonitis Assay – Product Status 201

Ascites Spontaneous Peritonitis Assay – Product Description 201

Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 202

Paper-Based Microfluidic Device – Brucella Abortus – Product Status 202

Paper-Based Microfluidic Device – Brucella Abortus – Product Description 202

Paper-Based Microfluidic Test – Syphilis – Product Status 203

Paper-Based Microfluidic Test – Syphilis – Product Description 203

Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 204

SAMBA II – Combo Test – Product Status 204

SAMBA II – Combo Test – Product Description 204

DNAE Group Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 205

Genalysis – Product Status 205

Genalysis – Product Description 205

Domus Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 206

Diagnostic Test – Bacteria – Product Status 206

Diagnostic Test – Bacteria – Product Description 206

Duke University Pipeline Products & Ongoing Clinical Trials Overview 207

Lateral Flow Assay – Salmonella Enterica – Product Status 207

Lateral Flow Assay – Salmonella Enterica – Product Description 207

DxDiscovery Inc Pipeline Products & Ongoing Clinical Trials Overview 208

Diagnostic Assay – Anthrax Infection – Product Status 208

Diagnostic Assay – Anthrax Infection – Product Description 208

Diagnostic Assay – Leptospirosis – Product Status 209

Diagnostic Assay – Leptospirosis – Product Description 209

Diagnostic Assay – Melioidosis – Product Status 209

Diagnostic Assay – Melioidosis – Product Description 210

Diagnostic Assay – Pertussis – Product Status 210

Diagnostic Assay – Pertussis – Product Description 210

Diagnostic Assay – Plague – Product Status 211

Diagnostic Assay – Plague – Product Description 211

Diagnostic Assay – Tularemia – Product Status 211

Diagnostic Assay – Tularemia – Product Description 212

DxNA LLC Pipeline Products & Ongoing Clinical Trials Overview 213

Staphylococcus.MDx MRSA+ Diagnostic Test – Product Status 213

Staphylococcus.MDx MRSA+ Diagnostic Test – Product Description 213

Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview 214

Dynasil Diagnostic Test – Tuberculosis – Product Status 214

Dynasil Diagnostic Test – Tuberculosis – Product Description 214

ECI Biotech Inc. Pipeline Products & Ongoing Clinical Trials Overview 215

ExpressDetect Diagnostic Test – Wound Infections – Product Status 215

ExpressDetect Diagnostic Test – Wound Infections – Product Description 215

Edan Instruments Inc Pipeline Products & Ongoing Clinical Trials Overview 216

CT3 – PCT Assay – Product Status 216

CT3 – PCT Assay – Product Description 216

Ellume Ltd Pipeline Products & Ongoing Clinical Trials Overview 217

ESP-Based Diagnostic Test – Chlamydia – Product Status 217

ESP-Based Diagnostic Test – Chlamydia – Product Description 217

Elvesys Inc Pipeline Products & Ongoing Clinical Trials Overview 218

Elvesys Point Of Care System – Product Status 218

Elvesys Point Of Care System – Product Description 218

Embryyo Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 219

Point Of Care Diagnostic Test – Sepsis – Product Status 219

Point Of Care Diagnostic Test – Sepsis – Product Description 219

EMPE Diagnostics AB Pipeline Products & Ongoing Clinical Trials Overview 220

mfloDx MDR-TB Test Kit – Product Status 220

mfloDx MDR-TB Test Kit – Product Description 220

Enigma Diagnostics Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 221

Enigma ML – CT/NG Assay – Product Status 221

Enigma ML – CT/NG Assay – Product Description 221

ENTvantage Dx Pipeline Products & Ongoing Clinical Trials Overview 222

Entvantage Dx Sinu-Test Assay Kit – Product Status 222

Entvantage Dx Sinu-Test Assay Kit – Product Description 222

ERBA Molecular Ltd Pipeline Products & Ongoing Clinical Trials Overview 223

Diagnostic Test – Campylobacter – Product Status 223

Diagnostic Test – Campylobacter – Product Description 223

Diagnostic Test – E. coli 0157 – Product Status 224

Diagnostic Test – E. coli 0157 – Product Description 224

Diagnostic Test – MRSA – Product Status 224

Diagnostic Test – MRSA – Product Description 225

Diagnostic Test – Salmonella – Product Status 225

Diagnostic Test – Salmonella – Product Description 225

Evolve Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 226

Evivo Stool Test – Product Status 226

Evivo Stool Test – Product Description 226

Fast Track Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 227

FTD MRSA Assay – Product Status 227

FTD MRSA Assay – Product Description 227

FTD Tuberculosis Assay – Product Status 228

FTD Tuberculosis Assay – Product Description 228

First Light Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 229

MultiPath MRSA Diagnostic Test – Product Status 229

MultiPath MRSA Diagnostic Test – Product Description 229

MultiPath VRE Diagnostic Test – Product Status 230

MultiPath VRE Diagnostic Test – Product Description 230

SensiTox B. Anthracis Toxin Test – Product Status 230

SensiTox B. Anthracis Toxin Test – Product Description 231

FK-Biotecnologia SA Pipeline Products & Ongoing Clinical Trials Overview 232

Point Of Care Test – Leptospirosis – Product Status 232

Point Of Care Test – Leptospirosis – Product Description 232

Point Of Care Test – Syphilis – Product Status 233

Point Of Care Test – Syphilis – Product Description 233

Fluxergy LLC Pipeline Products & Ongoing Clinical Trials Overview 234

Diagnostic Test – Clostridium Difficile Toxin A/B – Product Status 234

Diagnostic Test – Clostridium Difficile Toxin A/B – Product Description 234

Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 235

Antibody Detection Test – Product Status 235

Antibody Detection Test – Product Description 235

Fred Hutchinson Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 236

Metabolite Biomarker Test – Bacterial Vaginosis – Product Status 236

Metabolite Biomarker Test – Bacterial Vaginosis – Product Description 236

Free University of Brussels Pipeline Products & Ongoing Clinical Trials Overview 237

Diagnostic Tool – Bacterial Infection – Product Status 237

Diagnostic Tool – Bacterial Infection – Product Description 237

Fyodor Biotechnologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 238

Urine Based Test – Typhoid – Product Status 238

Urine Based Test – Typhoid – Product Description 238

GE Healthcare Pipeline Products & Ongoing Clinical Trials Overview 239

Paper Based Test – MRSA – Product Status 239

Paper Based Test – MRSA – Product Description 239

GeneBio Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 240

Salmonella Assay – Product Status 240

Salmonella Assay – Product Description 240

genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 241

Genedrive – Chlamydia Assay – Product Status 241

Genedrive – Chlamydia Assay – Product Description 241

Genedrive – MRSA Assay – Product Status 242

Genedrive – MRSA Assay – Product Description 242

Genedrive – Typhoid Assay – Product Status 242

Genedrive – Typhoid Assay – Product Description 243

GeneEx, Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 244

Rapid Antigen Test – GAS – Product Status 244

Rapid Antigen Test – GAS – Product Description 244

GenePOC Inc Pipeline Products & Ongoing Clinical Trials Overview 245

revogene – Bacillus atrophaeus subsp. globigii Assay – Product Status 245

revogene – Bacillus atrophaeus subsp. globigii Assay – Product Description 245

revogene – Bacillus subtilis Assay – Product Status 246

revogene – Bacillus subtilis Assay – Product Description 246

revogene – Campylobacter jejuni Assay – Product Status 246

revogene – Campylobacter jejuni Assay – Product Description 247

revogene – Enterococcus faecalis Assay – Product Status 247

revogene – Enterococcus faecalis Assay – Product Description 247

revogene – Escherichia coli Assay – Product Status 248

revogene – Escherichia coli Assay – Product Description 248

revogene – Salmonella enterica Assay – Product Status 248

revogene – Salmonella enterica Assay – Product Description 249

revogene – Staphylococcus Assay – Product Status 249

revogene – Staphylococcus Assay – Product Description 249

Genetic Signatures Ltd Pipeline Products & Ongoing Clinical Trials Overview 250

EasyScreen Assay – Atypical Pneumonia – Product Status 250

EasyScreen Assay – Atypical Pneumonia – Product Description 251

EasyScreen Assay – MRSA – Product Status 251

EasyScreen Assay – MRSA – Product Description 251

EasyScreen Assay – Tuberculosis – Product Status 252

EasyScreen Assay – Tuberculosis – Product Description 252

Global BioDiagnostics Corp. Pipeline Products & Ongoing Clinical Trials Overview 253

GBD TB Rapid Screen – Product Status 253

GBD TB Rapid Screen – Product Description 253

GBD TB REaD POC Assay – Product Status 254

GBD TB REaD POC Assay – Product Description 254

GNA Biosolutions GmbH Pipeline Products & Ongoing Clinical Trials Overview 255

Pitbul Ultrafast TB Test – Product Status 255

Pitbul Ultrafast TB Test – Product Description 255

SAGE Ultrafast Antibiotic Resistance Test – Product Status 256

SAGE Ultrafast Antibiotic Resistance Test – Product Description 256

Ultrafast Point Of Care Assay – MRSA – Product Status 256

Ultrafast Point Of Care Assay – MRSA – Product Description 257

Goodgene Inc Pipeline Products & Ongoing Clinical Trials Overview 258

Food Poisoning Multiplex PCR Kit – Product Status 258

Food Poisoning Multiplex PCR Kit – Product Description 258

Gradientech AB Pipeline Products & Ongoing Clinical Trials Overview 259

QuickMIC – Product Status 259

QuickMIC – Product Description 259

Great Basin Scientific Inc. Pipeline Products & Ongoing Clinical Trials Overview 260

SA Nasal Screen Test – Product Status 260

SA Nasal Screen Test – Product Description 260

Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 261

KromaHealth Kit – Bacterial Identification Test – Pr

Figures

Bacteriology Rapid Tests & POC – Pipeline Products by Stage of Development 40

Bacteriology Rapid Tests & POC – Pipeline Products by Segment 41

Bacteriology Rapid Tests & POC – Pipeline Products by Territory 42

Bacteriology Rapid Tests & POC – Pipeline Products by Regulatory Path 44

Bacteriology Rapid Tests & POC – Pipeline Products by Estimated Approval Date 45

Bacteriology Rapid Tests & POC – Ongoing Clinical Trials 46

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