Auto-Immune Diseases Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Auto-immune diseases Pipeline Market Report Overview

Auto-immune diseases are used for detection of autoimmune disorder by identifying auto-antibodies in the patient’s test sample. The auto-immune diseases pipeline market research report provides a comprehensive understanding of the pipeline products and their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Territories ·        The US

·        Europe

·        China

·        Canada

·        Singapore

Key Regulatory Paths ·        510(k)

·        CE-IVD

·        NMPA

·        MDL

Leading Companies ·        Aarhus University (Aarhus)

·        Adaptive Biotechnologies Corp (Adaptive)

·        BG Medicine Inc

·        Biogen Inc

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Auto-immune Diseases Pipeline Market Segmentation by Territories

A few of the key territories for auto-immune diseases pipeline products are the US, Europe, China, Canada, and Singapore among others. As of December 2023, the US accounted for the highest number of pipeline products.

Auto-immune Diseases Pipeline Market Analysis by Territories, 2023 (%)

Auto-immune Diseases Pipeline Market Analysis by Territories, 2023 (%)

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Auto-immune Diseases Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the auto-immune diseases pipeline market are 510(k), CE-IVD, NMPA, and MDL among others. As of December 2023, 510(k) was the most followed pathway for pipeline products in the market.

Auto-immune Diseases Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Auto-immune Diseases Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Auto-immune Diseases Pipeline Market – Competitive Landscape

A few of the key companies associated with the auto-immune diseases pipeline market are Aarhus University (Aarhus) among others.

Aarhus University: Aarhus is headquartered in Aarhus, Denmark. Aarhus University (Aarhus) provides educational and research services. The university offers bachelor’s degree programmes, master’s degree programs, and PhD programs in various disciplines. Its areas of academic interest comprise arts, science and technology, health and business and social sciences.

Adaptive Biotechnologies Corp (Adaptive): Adaptive is headquartered in Seattle, Washington, the US. The company is a developer of immune-driven medicine. Its products include immunoSEQ, T-Detect, Vaccines and clonoSEQ. The company provides an immune-sequencing platform to laboratories for conducting research in the areas of oncology and other immune-mediated diseases, and TCR screening for the development of vaccines.

Auto-immune Diseases Pipeline Market Analysis by Companies, 2023

Auto-immune Diseases Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Auto-immune diseases Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • Canada
  • Singapore

Auto-immune diseases Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE-IVD
  • NMPA
  • MDL

Scope

This report provides:

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

Reasons to Buy

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

Aarhus University
Adaptive Biotechnologies Corp
Aditxt Inc
Albert Ludwigs University of Freiburg
Alere Inc
Amarantus Diagnostics Inc
apDia nv
Asylia Diagnostics BV
Autoimmune Technologies LLC
Avotres Inc
Beckman Coulter Inc
Bellvitge Biomedical Research Institute
BG Medicine Inc
Biogen Inc
BIOHOPE Scientific SL
Biomedal SL
Bionure Farma SL (Inactive)
BioShai Ltd
Biotome Pty Ltd
CDI Laboratories Inc
Celdara Medical LLC
Charite University Hospital of Berlin
Chronix Biomedical Inc
Cincinnati Children's Hospital Medical Center
Cizzle Biotechnology Holdings Plc
Co-Diagnostics Inc
Columbia University
Crescendo Bioscience Inc
Department of Biomedical Engineering Columbia University
Digna Biotech SL
DNAlytics SA
Enterome Bioscience SA
Exagen Diagnostics Inc
Exodus Biosciences LLC
Ezose Sciences Inc.
Flamentera AG
Genalyte Inc
GeNeuro SA
Grifols SA
Guangzhou Wondfo Biotech Co Ltd
Hannover Medical School
HealthTell Inc
Helmholtz Centre for Infection Research
HOB Biotech Group Suzhou Co Ltd
Hospital for Special Surgery
HTG Molecular Diagnostics Inc
Hycor Biomedical Inc
Ignyta Inc
Immunarray Pvt Ltd
Immunovia AB
ImmusanT Inc
Innobiochips
Inova Diagnostics Inc
InterVenn BioSciences
Iron Horse Diagnostics, Inc.
Johns Hopkins University
Lankenau Institute for Medical Research
LineaGen Inc
Lophius Biosciences GmbH
Louisville Bioscience Inc (Inactive)
Max Delbruck Center for Molecular Medicine
Mayo Clinic
Medica Corp
Medical & Biological Laboratories Co Ltd
Metabiomics Corporation
Metabolomic Technologies Inc
Metanomics Health GmbH
MSDx Inc
Myriad Genetics Inc
Nanosphere Inc (Inactive)
Neuro Vigor LLC
NoToPharm srl
Numares AG
OmniBiome Therapeutics Inc
One Way Liver SL
OPKO Health Inc
Op-T-Mune Inc
Oxford Biodynamics Plc
Oxford Gene Technology Ltd
Oxford Immunotec Ltd
Pediatric Bioscience LLC
Penn State College of Medicine
Progentec Diagnostics Inc
Prometheus Biosciences Inc
Protagen AG
ProteinLogic Ltd
Psyros Diagnostics Ltd
Quanterix Corp
Rambam Health Care Campus
Rappaport Family Institute for Research in the Medical Science
Revvity Inc
Roche Diagnostics
Roche Diagnostics International Ltd
Royal College of Surgeons Ireland
Seattle Children's Hospital
Sengenics Corp Pte Ltd
Sequenom Inc
Shuwen Biotech Co Ltd
SomaLogic Inc
Southern Illinois University Carbondale
Spanish National Research Council
SQI Diagnostics Inc
Statens Serum Institut
Sugentech Inc
Svar Life Science AB
TBG Diagnostics Ltd
Tel Aviv University
The Walter and Eliza Hall Institute of Medical Research
Toscana Biomarkers Srl
University Health Network
University of Alberta
University of California Irvine
University of California San Francisco
University of Chicago
University of Colorado
University of Illinois at Chicago
University of Maryland Baltimore
University of Missouri
University of Oslo
University of Oxford
University of Pecs
US Biomarkers Inc
Veravas Inc
VolitionRX Ltd
Washington University in St Louis
XEPTAGEN SpA
Yale University

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 10

|1.2 List of Figures 21

2 Introduction 22

2.1 Auto-Immune Diseases Overview 22

3 Products under Development 23

3.1 Auto-Immune Diseases – Pipeline Products by Stage of Development 23

3.2 Auto-Immune Diseases – Pipeline Products by Territory 24

3.3 Auto-Immune Diseases – Pipeline Products by Regulatory Path 25

3.4 Auto-Immune Diseases – Pipeline Products by Estimated Approval Date 26

3.5 Auto-Immune Diseases – Ongoing Clinical Trials 27

4 Auto-Immune Diseases – Pipeline Products under Development by Companies 28

4.1 Auto-Immune Diseases Companies – Pipeline Products by Stage of Development 28

4.2 Auto-Immune Diseases – Pipeline Products by Stage of Development 33

5 Auto-Immune Diseases Companies and Product Overview 39

5.1 Aarhus University Company Overview 39

5.1.1 Aarhus University Pipeline Products & Ongoing Clinical Trials Overview 39

5.2 Adaptive Biotechnologies Corp Company Overview 41

5.2.1 Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 41

5.3 Aditxt Inc Company Overview 44

5.3.1 Aditxt Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.4 Albert Ludwigs University of Freiburg Company Overview 45

5.4.1 Albert Ludwigs University of Freiburg Pipeline Products & Ongoing Clinical Trials Overview 45

5.5 Alere Inc Company Overview 46

5.5.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.6 Amarantus Diagnostics Inc Company Overview 48

5.6.1 Amarantus Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.7 apDia nv Company Overview 50

5.7.1 apDia nv Pipeline Products & Ongoing Clinical Trials Overview 50

5.8 Asylia Diagnostics BV Company Overview 51

5.8.1 Asylia Diagnostics BV Pipeline Products & Ongoing Clinical Trials Overview 51

5.9 Autoimmune Technologies LLC Company Overview 53

5.9.1 Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 53

5.10 Avotres Inc Company Overview 57

5.10.1 Avotres Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.11 Beckman Coulter Inc Company Overview 58

5.11.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 58

5.12 Bellvitge Biomedical Research Institute Company Overview 59

5.12.1 Bellvitge Biomedical Research Institute Pipeline Products & Ongoing Clinical Trials Overview 59

5.13 BG Medicine Inc Company Overview 60

5.13.1 BG Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 60

5.14 Biogen Inc Company Overview 61

5.14.1 Biogen Inc Pipeline Products & Ongoing Clinical Trials Overview 61

5.15 BIOHOPE Scientific SL Company Overview 62

5.15.1 BIOHOPE Scientific SL Pipeline Products & Ongoing Clinical Trials Overview 62

5.16 Biomedal SL Company Overview 64

5.16.1 Biomedal SL Pipeline Products & Ongoing Clinical Trials Overview 64

5.17 Bionure Farma SL (Inactive) Company Overview 66

5.17.1 Bionure Farma SL (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 66

5.18 BioShai Ltd Company Overview 67

5.18.1 BioShai Ltd Pipeline Products & Ongoing Clinical Trials Overview 67

5.19 Biotome Pty Ltd Company Overview 70

5.19.1 Biotome Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 70

5.20 CDI Laboratories Inc Company Overview 71

5.20.1 CDI Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.21 Celdara Medical LLC Company Overview 72

5.21.1 Celdara Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 72

5.22 Charite University Hospital of Berlin Company Overview 73

5.22.1 Charite University Hospital of Berlin Pipeline Products & Ongoing Clinical Trials Overview 73

5.23 Chronix Biomedical Inc Company Overview 74

5.23.1 Chronix Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.24 Cincinnati Children’s Hospital Medical Center Company Overview 76

5.24.1 Cincinnati Children’s Hospital Medical Center Pipeline Products & Ongoing Clinical Trials Overview 76

5.25 Cizzle Biotechnology Holdings Plc Company Overview 77

5.25.1 Cizzle Biotechnology Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 77

5.26 Co-Diagnostics Inc Company Overview 78

5.26.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.27 Columbia University Company Overview 79

5.27.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 79

5.28 Crescendo Bioscience Inc Company Overview 80

5.28.1 Crescendo Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.29 Department of Biomedical Engineering Columbia University Company Overview 83

5.29.1 Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 83

5.30 Digna Biotech SL Company Overview 84

5.30.1 Digna Biotech SL Pipeline Products & Ongoing Clinical Trials Overview 84

5.31 DNAlytics SA Company Overview 86

5.31.1 DNAlytics SA Pipeline Products & Ongoing Clinical Trials Overview 86

5.32 Enterome Bioscience SA Company Overview 87

5.32.1 Enterome Bioscience SA Pipeline Products & Ongoing Clinical Trials Overview 87

5.33 Exagen Diagnostics Inc Company Overview 89

5.33.1 Exagen Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.34 Exodus Biosciences LLC Company Overview 92

5.34.1 Exodus Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 92

5.35 Ezose Sciences Inc. Company Overview 93

5.35.1 Ezose Sciences Inc. Pipeline Products & Ongoing Clinical Trials Overview 93

5.36 Flamentera AG Company Overview 94

5.36.1 Flamentera AG Pipeline Products & Ongoing Clinical Trials Overview 94

5.37 Genalyte Inc Company Overview 95

5.37.1 Genalyte Inc Pipeline Products & Ongoing Clinical Trials Overview 95

5.38 GeNeuro SA Company Overview 96

5.38.1 GeNeuro SA Pipeline Products & Ongoing Clinical Trials Overview 96

5.39 Grifols SA Company Overview 97

5.39.1 Grifols SA Pipeline Products & Ongoing Clinical Trials Overview 97

5.40 Guangzhou Wondfo Biotech Co Ltd Company Overview 98

5.40.1 Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 98

5.41 Hannover Medical School Company Overview 100

5.41.1 Hannover Medical School Pipeline Products & Ongoing Clinical Trials Overview 100

5.42 HealthTell Inc Company Overview 101

5.42.1 HealthTell Inc Pipeline Products & Ongoing Clinical Trials Overview 101

5.43 Helmholtz Centre for Infection Research Company Overview 107

5.43.1 Helmholtz Centre for Infection Research Pipeline Products & Ongoing Clinical Trials Overview 107

5.44 HOB Biotech Group Suzhou Co Ltd Company Overview 108

5.44.1 HOB Biotech Group Suzhou Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

5.45 Hospital for Special Surgery Company Overview 109

5.45.1 Hospital for Special Surgery Pipeline Products & Ongoing Clinical Trials Overview 109

5.46 HTG Molecular Diagnostics Inc Company Overview 110

5.46.1 HTG Molecular Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 110

5.47 Hycor Biomedical Inc Company Overview 111

5.47.1 Hycor Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 111

5.48 Ignyta Inc Company Overview 113

5.48.1 Ignyta Inc Pipeline Products & Ongoing Clinical Trials Overview 113

5.49 Immunarray Pvt Ltd Company Overview 115

5.49.1 Immunarray Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 115

5.50 Immunovia AB Company Overview 116

5.50.1 Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview 116

5.51 ImmusanT Inc Company Overview 120

5.51.1 ImmusanT Inc Pipeline Products & Ongoing Clinical Trials Overview 120

5.52 Innobiochips Company Overview 122

5.52.1 Innobiochips Pipeline Products & Ongoing Clinical Trials Overview 122

5.53 Inova Diagnostics Inc Company Overview 123

5.53.1 Inova Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 123

5.54 InterVenn BioSciences Company Overview 128

5.54.1 InterVenn BioSciences Pipeline Products & Ongoing Clinical Trials Overview 128

5.55 Iron Horse Diagnostics, Inc. Company Overview 129

5.55.1 Iron Horse Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 129

5.56 Johns Hopkins University Company Overview 131

5.56.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 131

5.57 Lankenau Institute for Medical Research Company Overview 132

5.57.1 Lankenau Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 132

5.58 LineaGen Inc Company Overview 133

5.58.1 LineaGen Inc Pipeline Products & Ongoing Clinical Trials Overview 133

5.59 Lophius Biosciences GmbH Company Overview 134

5.59.1 Lophius Biosciences GmbH Pipeline Products & Ongoing Clinical Trials Overview 134

5.60 Louisville Bioscience Inc (Inactive) Company Overview 135

5.60.1 Louisville Bioscience Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 135

5.61 Max Delbruck Center for Molecular Medicine Company Overview 138

5.61.1 Max Delbruck Center for Molecular Medicine Pipeline Products & Ongoing Clinical Trials Overview 138

5.62 Mayo Clinic Company Overview 139

5.62.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 139

5.63 Medica Corp Company Overview 140

5.63.1 Medica Corp Pipeline Products & Ongoing Clinical Trials Overview 140

5.64 Medical & Biological Laboratories Co Ltd Company Overview 143

5.64.1 Medical & Biological Laboratories Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

5.65 Metabiomics Corporation Company Overview 144

5.65.1 Metabiomics Corporation Pipeline Products & Ongoing Clinical Trials Overview 144

5.66 Metabolomic Technologies Inc Company Overview 147

5.66.1 Metabolomic Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 147

5.67 Metanomics Health GmbH Company Overview 150

5.67.1 Metanomics Health GmbH Pipeline Products & Ongoing Clinical Trials Overview 150

5.68 MSDx Inc Company Overview 151

5.68.1 MSDx Inc Pipeline Products & Ongoing Clinical Trials Overview 151

5.69 Myriad Genetics Inc Company Overview 152

5.69.1 Myriad Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 152

5.70 Nanosphere Inc (Inactive) Company Overview 153

5.70.1 Nanosphere Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 153

5.71 Neuro Vigor LLC Company Overview 154

5.71.1 Neuro Vigor LLC Pipeline Products & Ongoing Clinical Trials Overview 154

5.72 NoToPharm srl Company Overview 155

5.72.1 NoToPharm srl Pipeline Products & Ongoing Clinical Trials Overview 155

5.73 Numares AG Company Overview 160

5.73.1 Numares AG Pipeline Products & Ongoing Clinical Trials Overview 160

5.74 OmniBiome Therapeutics Inc Company Overview 161

5.74.1 OmniBiome Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 161

5.75 One Way Liver SL Company Overview 162

5.75.1 One Way Liver SL Pipeline Products & Ongoing Clinical Trials Overview 162

5.76 OPKO Health Inc Company Overview 163

5.76.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.77 Op-T-Mune Inc Company Overview 164

5.77.1 Op-T-Mune Inc Pipeline Products & Ongoing Clinical Trials Overview 164

5.78 Oxford Biodynamics Plc Company Overview 165

5.78.1 Oxford Biodynamics Plc Pipeline Products & Ongoing Clinical Trials Overview 165

5.79 Oxford Gene Technology Ltd Company Overview 166

5.79.1 Oxford Gene Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 166

5.80 Oxford Immunotec Ltd Company Overview 167

5.80.1 Oxford Immunotec Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

5.81 Pediatric Bioscience LLC Company Overview 168

5.81.1 Pediatric Bioscience LLC Pipeline Products & Ongoing Clinical Trials Overview 168

5.82 Penn State College of Medicine Company Overview 169

5.82.1 Penn State College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 169

5.83 Progentec Diagnostics Inc Company Overview 170

5.83.1 Progentec Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 170

5.84 Prometheus Biosciences Inc Company Overview 176

5.84.1 Prometheus Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 176

5.85 Protagen AG Company Overview 181

5.85.1 Protagen AG Pipeline Products & Ongoing Clinical Trials Overview 181

5.86 ProteinLogic Ltd Company Overview 186

5.86.1 ProteinLogic Ltd Pipeline Products & Ongoing Clinical Trials Overview 186

5.87 Psyros Diagnostics Ltd Company Overview 187

5.87.1 Psyros Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 187

5.88 Quanterix Corp Company Overview 188

5.88.1 Quanterix Corp Pipeline Products & Ongoing Clinical Trials Overview 188

5.89 Rambam Health Care Campus Company Overview 190

5.89.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 190

5.90 Rappaport Family Institute for Research in the Medical Science Company Overview 191

5.90.1 Rappaport Family Institute for Research in the Medical Science Pipeline Products & Ongoing Clinical Trials Overview 191

5.91 Revvity Inc Company Overview 192

5.91.1 Revvity Inc Pipeline Products & Ongoing Clinical Trials Overview 192

5.92 Roche Diagnostics Company Overview 193

5.92.1 Roche Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 193

5.93 Roche Diagnostics International Ltd Company Overview 195

5.93.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 195

5.94 Royal College of Surgeons Ireland Company Overview 198

5.94.1 Royal College of Surgeons Ireland Pipeline Products & Ongoing Clinical Trials Overview 198

5.95 Seattle Children’s Hospital Company Overview 199

5.95.1 Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 199

5.96 Sengenics Corp Pte Ltd Company Overview 201

5.96.1 Sengenics Corp Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 201

5.97 Sequenom Inc Company Overview 205

5.97.1 Sequenom Inc Pipeline Products & Ongoing Clinical Trials Overview 205

5.98 Shuwen Biotech Co Ltd Company Overview 206

5.98.1 Shuwen Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

5.99 SomaLogic Inc Company Overview 207

5.99.1 SomaLogic Inc Pipeline Products & Ongoing Clinical Trials Overview 207

5.100 Southern Illinois University Carbondale Company Overview 208

5.100.1 Southern Illinois University Carbondale Pipeline Products & Ongoing Clinical Trials Overview 208

5.101 Spanish National Research Council Company Overview 210

5.101.1 Spanish National Research Council Pipeline Products & Ongoing Clinical Trials Overview 210

5.102 SQI Diagnostics Inc Company Overview 211

5.102.1 SQI Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 211

5.103 Statens Serum Institut Company Overview 216

5.103.1 Statens Serum Institut Pipeline Products & Ongoing Clinical Trials Overview 216

5.104 Sugentech Inc Company Overview 217

5.104.1 Sugentech Inc Pipeline Products & Ongoing Clinical Trials Overview 217

5.105 Svar Life Science AB Company Overview 218

5.105.1 Svar Life Science AB Pipeline Products & Ongoing Clinical Trials Overview 218

5.106 TBG Diagnostics Ltd Company Overview 219

5.106.1 TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 219

5.107 Tel Aviv University Company Overview 220

5.107.1 Tel Aviv University Pipeline Products & Ongoing Clinical Trials Overview 220

5.108 The Walter and Eliza Hall Institute of Medical Research Company Overview 221

5.108.1 The Walter and Eliza Hall Institute of Medical Research Pipeline Products & Ongoing Clinical Trials Overview 221

5.109 Toscana Biomarkers Srl Company Overview 222

5.109.1 Toscana Biomarkers Srl Pipeline Products & Ongoing Clinical Trials Overview 222

5.110 University Health Network Company Overview 226

5.110.1 University Health Network Pipeline Products & Ongoing Clinical Trials Overview 226

5.111 University of Alberta Company Overview 227

5.111.1 University of Alberta Pipeline Products & Ongoing Clinical Trials Overview 227

5.112 University of California Irvine Company Overview 228

5.112.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 228

5.113 University of California San Francisco Company Overview 229

5.113.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 229

5.114 University of Chicago Company Overview 232

5.114.1 University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 232

5.115 University of Colorado Company Overview 233

5.115.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 233

5.116 University of Illinois at Chicago Company Overview 235

5.116.1 University of Illinois at Chicago Pipeline Products & Ongoing Clinical Trials Overview 235

5.117 University of Maryland Baltimore Company Overview 236

5.117.1 University of Maryland Baltimore Pipeline Products & Ongoing Clinical Trials Overview 236

5.118 University of Missouri Company Overview 237

5.118.1 University of Missouri Pipeline Products & Ongoing Clinical Trials Overview 237

5.119 University of Oslo Company Overview 238

5.119.1 University of Oslo Pipeline Products & Ongoing Clinical Trials Overview 238

5.120 University of Oxford Company Overview 239

5.120.1 University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 239

5.121 University of Pecs Company Overview 241

5.121.1 University of Pecs Pipeline Products & Ongoing Clinical Trials Overview 241

5.122 US Biomarkers Inc Company Overview 242

5.122.1 US Biomarkers Inc Pipeline Products & Ongoing Clinical Trials Overview 242

5.123 Veravas Inc Company Overview 243

5.123.1 Veravas Inc Pipeline Products & Ongoing Clinical Trials Overview 243

5.124 VolitionRX Ltd Company Overview 244

5.124.1 VolitionRX Ltd Pipeline Products & Ongoing Clinical Trials Overview 244

5.125 Washington University in St Louis Company Overview 247

5.125.1 Washington University in St Louis Pipeline Products & Ongoing Clinical Trials Overview 247

5.126 XEPTAGEN SpA Company Overview 248

5.126.1 XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 248

5.127 Yale University Company Overview 249

5.127.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview 249

6 Auto-Immune Diseases- Recent Developments 250

6.1 Dec 13, 2023: Thermo Fisher Scientific Signs Long-Term, Exclusive U.S. Distributor Agreement With Aesku.Group for IFA Testing Kits & Instruments 250

6.2 Dec 12, 2023: Genentech Announces Appointment of Ashley Magargee as Chief Executive Officer 250

6.3 Dec 05, 2023: Siemens Healthineers Appoints Vivek Kanade as New Head For Its Middle East and Africa Operations 251

6.4 Nov 30, 2023: Wilmot L. Matthews Announces Resignation as Director of SQI Diagnostics Debt Forgiveness, Voting Trust Agreement and Related Transactions 251

6.5 Nov 28, 2023: Quest Diagnostics and Scipher Medicine Collaborate to Scale Precision Medicine Access for Patients with Rheumatoid Arthritis 252

6.6 Nov 28, 2023: Thermo Fisher Scientific Prices Offering Of $2.5 Bln Of Senior Notes 253

6.7 Nov 09, 2023: Roche’s MS test scores FDA breakthrough device designation 253

6.8 Nov 02, 2023: Immunovia Announces Invitation to Q3 Presentation 254

6.9 Nov 01, 2023: CareDx Announces CEO Transition 254

6.10 Oct 25, 2023: HSS Appoints New Leadership in Neurology and Anesthesia 255

6.11 Oct 18, 2023: Roche IL-6 Is the First Immunoassay Approved to Aid Sepsis Diagnosis in Newborns 255

6.12 Oct 11, 2023: Octave Bioscience Presents Data Highlighting Application and Impact of its Precision Care Solution at MSMilan2023 256

6.13 Oct 11, 2023: Theradiag Reports 20% Revenue Growth in Q3 2023 257

6.14 Oct 04, 2023: ROME Expands Leadership Team with the Appointment of Industry Veteran Kyle Kuvalanka as Chief Financial Officer and Chief Business Officer 257

6.15 Sep 14, 2023: Kronus Receives Additional 510(k) Clearance for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit 258

6.16 Sep 07, 2023: Scipher Medicine Receives Medicare Coverage for PrismRA Test in Rheumatoid Arthritis Patients 258

6.17 Sep 04, 2023: Grifols names Dr. Jorg Schüttrumpf Chief Scientific Innovation Officer 259

6.18 Sep 01, 2023: Adaptive Biotechnologies Corp. Announces Kevin Conroy Resigns from the Board 259

6.19 Aug 30, 2023: Octave Bioscience, Announces Publication of Clinical Validation Study Results of Its Novel, Multivariate Multiple Sclerosis Disease Activity (MSDA) Blood Test 260

6.20 Aug 30, 2023: Immunovia Publishes Interim Report for January-June 2023 261

6.21 Aug 29, 2023: Co-Diagnostics Appoints Chief Regulatory Affairs Officer 261

6.22 Aug 28, 2023: Bio-Rad to Participate in Fireside Chat During Wells Fargo’s 2023 Healthcare Conference 262

6.23 Aug 23, 2023: Immunovia Announces Invitation for Q2 Presentation 262

6.24 Aug 17, 2023: Myriad Genetics to Host Investor Day on September 19, 2023 262

6.25 Aug 14, 2023: Thermo Fisher Scientific to Trim Staff by More Than 200 at Florida Site 263

6.26 Jul 17, 2023: Theradiag Reports Revenue of €6.7 Million for the First Half of 2023, up

6.8% 263

6.27 Jul 06, 2023: Trinity Biotech Announces Q1 2023 Financial Results 263

6.28 Jul 05, 2023: Thermo Fisher Scientific to Hold Earnings Conference Call on Wednesday, July 26, 2023 267

6.29 Jun 15, 2023: Immuno Concepts Receives 510(k) Clearance for IgG Anti-nDNA Fluorescent Test System 267

6.30 Jun 13, 2023: HSS Appoints Mary E. Cassai, RN to Executive Vice President, Chief Operating Officer 268

6.31 May 30, 2023: SQI Diagnostics reports second quarter 2023 results 268

6.32 May 22, 2023: Immunovia: Changes to the nomination committee’s proposal to the annual general meeting 2023 270

6.33 May 09, 2023: Grifols delivers strong first quarter financials with 23% revenue growth and an adjusted EBITDA margin above guidance of 21% 270

6.34 May 08, 2023: CareDx to report first quarter 2023 financial results 272

6.35 May 05, 2023: Co-Diagnostics announces first quarter 2023 earnings release date and webcast 272

6.36 May 03, 2023: Adaptive Biotechnologies reports First Quarter 2023 financial results 272

6.37 May 03, 2023: Myriad Genetics reports first quarter 2023 financial results 274

6.38 Apr 25, 2023: OPKO Health to report Q1 2023 financial results on May 3, 2023 275

6.39 Apr 21, 2023: Immunovia announces annual report for 2022 275

6.40 Apr 20, 2023: QIAGEN announces expansion of supervisory board 276

6.41 Mar 16, 2023: Immunovia Announces Bulletin from the extraordinary general meeting 277

6.42 Mar 13, 2023: Provention Bio Cancels Fourth Quarter and Full Year 2022 Earnings Release and Conference Call 277

6.43 Mar 09, 2023: Co-diagnostics Announces Fourth Quarter and Full Year 2022 Earnings Release Date and Webcast 277

6.44 Mar 08, 2023: UCSF Health Appoints Two Prominent Healthcare Executives to Senior Leadership Positions 278

6.45 Mar 03, 2023: Grifols Announces Full Year 2022 Earnings 278

6.46 Mar 01, 2023: Immunovia appoints Karl Stone as new chief operating officer to develop R&D and operations 278

6.47 Feb 25, 2023: Octave presents data from nine company and partner abstracts at ACTRIMS Forum 2023 278

6.48 Feb 23, 2023: Immunovia Publishes Full Year Report for 2022 280

6.49 Feb 22, 2023: Prometheus Biosciences announces two oral presentations on PRA023 at the 18th Congress of European Crohn’s and Colitis Organisation (ECCO) 280

6.50 Feb 22, 2023: Thomas Glanzmann new Grifols Executive Chairman, after Steven F. Mayer resignation 281

6.51 Feb 21, 2023: CareDx to Report Fourth Quarter and Full Year 2022 Financial Results 282

6.52 Feb 20, 2023: Immunovia Notice of Extraordinary General Meeting 282

6.53 Feb 20, 2023: Immunovia’s Invitation to Q4 presentation 284

6.54 Feb 16, 2023: OPKO Health to Report Fourth Quarter 2022 Financial Results on February 23, 2023 285

6.55 Feb 15, 2023: World Leader In Musculoskeletal Health HSS Announces Douglas E. Padgett, MD to become Next Surgeon-in-Chief and Medical Director 285

6.56 Feb 14, 2023: Adaptive Biotechnologies Reports Fourth Quarter and Full Year 2022 Financial Results 286

6.57 Feb 07, 2023: QIAGEN Exceeds Outlook for Fourth Quarter and Full-Year 2022 With 14% CER Sales Growth in FY 2022 From Non-COVID Product Groups 287

6.58 Feb 06, 2023: Hospital for Special Surgery Announces Rightmove Appoints Marcus Osborne As Ceo 288

6.59 Jan 27, 2023: Hospital for Special Surgery Announces Leadership Change 289

6.60 Jan 23, 2023: Adaptive Biotechnologies to Report Fourth Quarter and Full Year 2022 Financial Results on February 14, 2023 291

6.61 Jan 16, 2023: TheraDiag Reports 2022 Revenue of €12.2 Million, up

9.7% 291

6.62 Jan 13, 2023: HSS Florida Continues to Grow With Appointment of Tara M. McCoy As CEO 292

6.63 Jan 06, 2023: Bio-Rad to Report Fourth Quarter and Full Year 2022 Financial Results on Thursday, February 16, 2023 293

7 Appendix 294

7.1 Methodology 294

7.2 About GlobalData 297

7.3 Contact Us 297

7.4 Disclaimer 297

Table

Auto-Immune Diseases – Pipeline Products by Stage of Development 23

Auto-Immune Diseases – Pipeline Products by Territory 24

Auto-Immune Diseases – Pipeline Products by Regulatory Path 25

Auto-Immune Diseases – Pipeline Products by Estimated Approval Date 26

Auto-Immune Diseases – Ongoing Clinical Trials 27

Auto-Immune Diseases Companies – Pipeline Products by Stage of Development 28

Auto-Immune Diseases – Pipeline Products by Stage of Development 33

Aarhus University Pipeline Products & Ongoing Clinical Trials Overview 39

Biomarker Test – Autoimmune Diseases – Product Status 39

Biomarker Test – Autoimmune Diseases – Product Description 39

Biomarker Test – Multiple Sclerosis – Product Status 40

Biomarker Test – Multiple Sclerosis – Product Description 40

Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 41

Non-Invasive Diagnostic Test – Celiac Disease – Product Status 41

Non-Invasive Diagnostic Test – Celiac Disease – Product Description 41

T-Detect – Multiple Sclerosis – Product Status 42

T-Detect – Multiple Sclerosis – Product Description 42

T-Detect – Rheumatoid Arthritis – Product Status 42

T-Detect – Rheumatoid Arthritis – Product Description 43

T-Detect – Ulcerative Colitis – Product Status 43

T-Detect – Ulcerative Colitis – Product Description 43

Aditxt Inc Pipeline Products & Ongoing Clinical Trials Overview 44

AditxtScore – Autoimmune Diseases – Product Status 44

AditxtScore – Autoimmune Diseases – Product Description 44

Albert Ludwigs University of Freiburg Pipeline Products & Ongoing Clinical Trials Overview 45

Biomarker Based Assay – Systemic Sclerosis – Product Status 45

Biomarker Based Assay – Systemic Sclerosis – Product Description 45

Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 46

AIMS System – Cardiolipin IgG Test – Product Status 46

AIMS System – Cardiolipin IgG Test – Product Description 46

AtheNA Multi-Lyte System – Cardiolipin IgG Test – Product Status 47

AtheNA Multi-Lyte System – Cardiolipin IgG Test – Product Description 47

Amarantus Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 48

Diagnostic Assay – Neuromyelitis Optica – Product Status 48

Diagnostic Assay – Neuromyelitis Optica – Product Description 48

Diagnostic Assay – Paraneoplastic Disease – Product Status 49

Diagnostic Assay – Paraneoplastic Disease – Product Description 49

apDia nv Pipeline Products & Ongoing Clinical Trials Overview 50

Diagnostic Test – MS (Multiple Sclerosis) – Product Status 50

Diagnostic Test – MS (Multiple Sclerosis) – Product Description 50

Asylia Diagnostics BV Pipeline Products & Ongoing Clinical Trials Overview 51

CDx Assay – Systemic Lupus Erythematosus – Product Status 51

CDx Assay – Systemic Lupus Erythematosus – Product Description 51

CDx Assay – Systemic Sclerosis (SS) – Product Status 52

CDx Assay – Systemic Sclerosis (SS) – Product Description 52

Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 53

Anti-Squalene Antibody Assay – Gulf War Syndrome – Product Status 53

Anti-Squalene Antibody Assay – Gulf War Syndrome – Product Description 53

Autoimmune Disease Virus Assay – Grave’s Disease – Product Status 54

Autoimmune Disease Virus Assay – Grave’s Disease – Product Description 54

Autoimmune Disease Virus Assay – Juvenile Rheumatoid Arthritis – Product Status 54

Autoimmune Disease Virus Assay – Juvenile Rheumatoid Arthritis – Product Description 55

Autoimmune Disease Virus Assay – Sjogren Syndrome – Product Status 55

Autoimmune Disease Virus Assay – Sjogren Syndrome – Product Description 55

Autoimmune Disease Virus Assay – Systemic Lupus Erythematosus – Product Status 56

Autoimmune Disease Virus Assay – Systemic Lupus Erythematosus – Product Description 56

Avotres Inc Pipeline Products & Ongoing Clinical Trials Overview 57

AVT-Dx001 – Product Status 57

AVT-Dx001 – Product Description 57

Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 58

SYNCHRON LXi 725 Anti-dsDNA Assay – Product Status 58

SYNCHRON LXi 725 Anti-dsDNA Assay – Product Description 58

Bellvitge Biomedical Research Institute Pipeline Products & Ongoing Clinical Trials Overview 59

Diagnostic Device – Autoimmune Encephalitis – Product Status 59

Diagnostic Device – Autoimmune Encephalitis – Product Description 59

BG Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 60

Diagnostic Assay – Multiple Sclerosis – Product Status 60

Diagnostic Assay – Multiple Sclerosis – Product Description 60

Biogen Inc Pipeline Products & Ongoing Clinical Trials Overview 61

Companion Diagnostic Test – Sjogren’s Syndrome – Product Status 61

Companion Diagnostic Test – Sjogren’s Syndrome – Product Description 61

BIOHOPE Scientific SL Pipeline Products & Ongoing Clinical Trials Overview 62

Immunobiogram – Lupus – Product Status 62

Immunobiogram – Lupus – Product Description 62

Immunobiogram – Psoriasis – Product Status 63

Immunobiogram – Psoriasis – Product Description 63

Biomedal SL Pipeline Products & Ongoing Clinical Trials Overview 64

ELISA DELIAC GFD – Product Status 64

ELISA DELIAC GFD – Product Description 64

Stick DELIAC GFD – Product Status 65

Stick DELIAC GFD – Product Description 65

Bionure Farma SL (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 66

BN – 301 Diagnostic/Prognostic Test – Product Status 66

BN – 301 Diagnostic/Prognostic Test – Product Description 66

BioShai Ltd Pipeline Products & Ongoing Clinical Trials Overview 67

PDx Prognostic Test – Product Status 67

PDx Prognostic Test – Product Description 67

PDx Screening Test – Product Status 68

PDx Screening Test – Product Description 68

PDx Test – Product Status 68

PDx Test – Product Description 69

Biotome Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 70

Biomarker-Based Diagnostic Test – Acute Rheumatic Fever – Product Status 70

Biomarker-Based Diagnostic Test – Acute Rheumatic Fever – Product Description 70

CDI Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 71

Diagnostic Test – Systemic Lupus Erythematosus – Product Status 71

Diagnostic Test – Systemic Lupus Erythematosus – Product Description 71

Celdara Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 72

Diagnostic Assay – Diabetes – Product Status 72

Diagnostic Assay – Diabetes – Product Description 72

Charite University Hospital of Berlin Pipeline Products & Ongoing Clinical Trials Overview 73

Diagnostic Test – Celiac Disease – Product Status 73

Diagnostic Test – Celiac Disease – Product Description 73

Chronix Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 74

Companion Diagnostic Test – Multiple Sclerosis – Product Status 74

Companion Diagnostic Test – Multiple Sclerosis – Product Description 74

Diagnostic Test – Systemic Lupus Erythematous – Product Status 75

Diagnostic Test – Systemic Lupus Erythematous – Product Description 75

Cincinnati Children’s Hospital Medical Center Pipeline Products & Ongoing Clinical Trials Overview 76

Biomarker Panel – Lupus Nephritis – Product Status 76

Biomarker Panel – Lupus Nephritis – Product Description 76

Cizzle Biotechnology Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 77

Companion Diagnostic Test – Autoimmune Disease – Product Status 77

Companion Diagnostic Test – Autoimmune Disease – Product Description 77

Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 78

Diagnostic Test – Auto-immune Disorder – Product Status 78

Diagnostic Test – Auto-immune Disorder – Product Description 78

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 79

Diagnostic Assay- NCGS/NCWS – Product Status 79

Diagnostic Assay- NCGS/NCWS – Product Description 79

Crescendo Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 80

Multi-Biomarker Test – Ankylosing Spondylitis – Product Status 80

Multi-Biomarker Test – Ankylosing Spondylitis – Product Description 80

Multi-Biomarker Test – Autoimmune Diseases – Product Status 81

Multi-Biomarker Test – Autoimmune Diseases – Product Description 81

Multi-Biomarker Test – Psoriatic Arthritis – Product Status 81

Multi-Biomarker Test – Psoriatic Arthritis – Product Description 82

Multi-Biomarker Test – Systemic Lupus Erythematosus – Product Status 82

Multi-Biomarker Test – Systemic Lupus Erythematosus – Product Description 82

Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 83

AutoDetect – Autoimmune Lupus Mediated Myocarditis – Product Status 83

AutoDetect – Autoimmune Lupus Mediated Myocarditis – Product Description 83

Digna Biotech SL Pipeline Products & Ongoing Clinical Trials Overview 84

Anti-CD-137 Antibodies Assay – Product Status 84

Anti-CD-137 Antibodies Assay – Product Description 84

Prognostic Test – Multiple Sclerosis – Product Status 85

Prognostic Test – Multiple Sclerosis – Product Description 85

DNAlytics SA Pipeline Products & Ongoing Clinical Trials Overview 86

RheumaKit-Tx – Product Status 86

RheumaKit-Tx – Product Description 86

Enterome Bioscience SA Pipeline Products & Ongoing Clinical Trials Overview 87

Diagnostic Test – Multiple Sclerosis – Product Status 87

Diagnostic Test – Multiple Sclerosis – Product Description 87

Diagnostic Test – Type 2 Diabetes – Product Status 88

Diagnostic Test – Type 2 Diabetes – Product Description 88

Exagen Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 89

AVISE RA Dx – Product Status 89

AVISE RA Dx – Product Description 89

AVISE RA Monitoring Device – Product Status 90

AVISE RA Monitoring Device – Product Description 90

AVISE RA Prognostic Device – Product Status 90

AVISE RA Prognostic Device – Product Description 91

AVISE SLE Monitor Plus – Product Status 91

AVISE SLE Monitor Plus – Product Description 91

Exodus Biosciences LLC Pipeline Products & Ongoing Clinical Trials Overview 92

AIMS – Product Status 92

AIMS – Product Description 92

Ezose Sciences Inc. Pipeline Products & Ongoing Clinical Trials Overview 93

Biomarker Diagnostic Assay – Multiple Sclerosis – Product Status 93

Biomarker Diagnostic Assay – Multiple Sclerosis – Product Description 93

Flamentera AG Pipeline Products & Ongoing Clinical Trials Overview 94

Diagnostic Test – Celiac Disease – Product Status 94

Diagnostic Test – Celiac Disease – Product Description 94

Genalyte Inc Pipeline Products & Ongoing Clinical Trials Overview 95

Maverick ANA 11 Assay Kit – Product Status 95

Maverick ANA 11 Assay Kit – Product Description 95

GeNeuro SA Pipeline Products & Ongoing Clinical Trials Overview 96

MSRV-Env Based Diagnostic Test – Multiple Sclerosis – Product Status 96

MSRV-Env Based Diagnostic Test – Multiple Sclerosis – Product Description 96

Grifols SA Pipeline Products & Ongoing Clinical Trials Overview 97

Diagnostic Test – Autoimmune Diseases – Product Status 97

Diagnostic Test – Autoimmune Diseases – Product Description 97

Guangzhou Wondfo Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 98

Finecare Diagnostic Assay – Anti-CCP – Product Status 98

Finecare Diagnostic Assay – Anti-CCP – Product Description 99

Finecare Diagnostic Assay – RF – Product Status 99

Finecare Diagnostic Assay – RF – Product Description 99

Hannover Medical School Pipeline Products & Ongoing Clinical Trials Overview 100

Diagnostic Test – Multiple Sclerosis – Product Status 100

Diagnostic Test – Multiple Sclerosis – Product Description 100

HealthTell Inc Pipeline Products & Ongoing Clinical Trials Overview 101

ImmunoSignature Test – Dermatomyositis – Product Status 101

ImmunoSignature Test – Dermatomyositis – Product Description 101

ImmunoSignature Test – Multiple Sclerosis – Product Status 102

ImmunoSignature Test – Multiple Sclerosis – Product Description 102

ImmunoSignature Test – Rheumatoid Arthritis – Product Status 102

ImmunoSignature Test – Rheumatoid Arthritis – Product Description 103

ImmunoSignature Test – Scleroderma – Product Status 103

ImmunoSignature Test – Scleroderma – Product Description 103

ImmunoSignature Test – Sjogren’s Syndrome – Product Status 104

ImmunoSignature Test – Sjogren’s Syndrome – Product Description 104

ImmunoSignature Test – SLE Differential Dx – Product Status 104

ImmunoSignature Test – SLE Differential Dx – Product Description 105

ImmunoSignature Test – SLE-Disease Activty/Flare – Product Status 105

ImmunoSignature Test – SLE-Disease Activty/Flare – Product Description 105

ImmunoSignature Test – Ulcerative Colitis – Product Status 106

ImmunoSignature Test – Ulcerative Colitis – Product Description 106

Helmholtz Centre for Infection Research Pipeline Products & Ongoing Clinical Trials Overview 107

ELISA Based Assay – Rheumatic Fever – Product Status 107

ELISA Based Assay – Rheumatic Fever – Product Description 107

HOB Biotech Group Suzhou Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

HOB Biotech Diagnostic Assay – Auto-immunity – Product Status 108

HOB Biotech Diagnostic Assay – Auto-immunity – Product Description 108

Hospital for Special Surgery Pipeline Products & Ongoing Clinical Trials Overview 109

Biomarker Test – Systemic Lupus Erythematosus – Product Status 109

Biomarker Test – Systemic Lupus Erythematosus – Product Description 109

HTG Molecular Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 110

NGS-Based Theranostic Tool – Product Status 110

NGS-Based Theranostic Tool – Product Description 110

Hycor Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 111

HYTEC 288 PLUS – Centromere Test – Product Status 111

HYTEC 288 PLUS – Centromere Test – Product Description 111

HYTEC 288 PLUS – ANCA Profile Test – Product Status 112

HYTEC 288 PLUS – ANCA Profile Test – Product Description 112

Ignyta Inc Pipeline Products & Ongoing Clinical Trials Overview 113

TrailblazeDx Test – Systemic Lupus Erythemetosus – Product Status 113

TrailblazeDx Test – Systemic Lupus Erythemetosus – Product Description 113

TrailblazeTx Test – SLE (Systemic Lupus Erythemetosus) – Product Status 114

TrailblazeTx Test – SLE (Systemic Lupus Erythemetosus) – Product Description 114

Immunarray Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 115

Diagnostic Test – Multiple Sclerosis – Product Status 115

Diagnostic Test – Multiple Sclerosis – Product Description 115

Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview 116

IMMray Primary Sjogren’s Syndrome Assay – Product Status 116

IMMray Primary Sjogren’s Syndrome Assay – Product Description 117

IMMray Rheumatoid Arthritis Assay – Product Status 117

IMMray Rheumatoid Arthritis Assay – Product Description 117

IMMray SLE-d Test – Product Status 118

IMMray SLE-d Test – Product Description 118

IMMray Systemic Vasculitis Assay – Product Status 118

IMMray Systemic Vasculitis Assay – Product Description 119

ImmusanT Inc Pipeline Products & Ongoing Clinical Trials Overview 120

Nexvax2 Companion Diagnostic Test – Product Status 120

Nexvax2 Companion Diagnostic Test – Product Description 120

Serology Test – Celiac Disease – Product Status 121

Serology Test – Celiac Disease – Product Description 121

Innobiochips Pipeline Products & Ongoing Clinical Trials Overview 122

Diagnostic Assay – Autoimmune Diseases – Product Status 122

Diagnostic Assay – Autoimmune Diseases – Product Description 122

Inova Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 123

BIO-FLASH – ANA Profile Assay – Product Status 123

BIO-FLASH – ANA Profile Assay – Product Description 123

BIO-FLASH – Chromatin Assay – Product Status 124

BIO-FLASH – Chromatin Assay – Product Description 124

BIO-FLASH – F Actin Assay – Product Status 124

BIO-FLASH – F Actin Assay – Product Description 125

BIO-FLASH – gp210 Assay – Product Status 125

BIO-FLASH – gp210 Assay – Product Description 125

BIO-FLASH – sp100 Assay – Product Status 126

BIO-FLASH – sp100 Assay – Product Description 126

Biomarker Test – Autoimmune Liver Disease – Product Status 126

Biomarker Test – Autoimmune Liver Disease – Product Description 127

InterVenn BioSciences Pipeline Products & Ongoing Clinical Trials Overview 128

Treatment Monitoring Panel – Autoimmune Diseases – Product Status 128

Treatment Monitoring Panel – Autoimmune Diseases – Product Description 128

Iron Horse Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 129

ALS Biologic Prognostic Test – Product Status 129

ALS Biologic Prognostic Test – Product Description 129

Multiple Sclerosis Disease Activity/Treatment Response Test – Product Status 130

Multiple Sclerosis Disease Activity/Treatment Response Test – Product Description 130

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 131

Biomarker Based Diagnostic Assay – Multiple Sclerosis – Product Status 131

Biomarker Based Diagnostic Assay – Multiple Sclerosis – Product Description 131

Lankenau Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 132

ANRE Assay – Product Status 132

ANRE Assay – Product Description 132

LineaGen Inc Pipeline Products & Ongoing Clinical Trials Overview 133

Diagnostic Test – Multiple Sclerosis – Product Status 133

Diagnostic Test – Multiple Sclerosis – Product Description 133

Lophius Biosciences GmbH Pipeline Products & Ongoing Clinical Trials Overview 134

T-Track Multiple Sclerosis – Product Status 134

T-Track Multiple Sclerosis – Product Description 134

Louisville Bioscience Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 135

Lupus pT Autoimmune Test – Product Status 135

Lupus pT Autoimmune Test – Product Description 135

Multiple Sclerosis pT Autoimmune Test – Product Status 136

Multiple Sclerosis pT Autoimmune Test – Product Description 136

Polymyositis pT Autoimmune Test – Product Status 136

Polymyositis pT Autoimmune Test – Product Description 137

Scleroderma pT Autoimmune Test – Product Status 137

Scleroderma pT Autoimmune Test – Product Description 137

Max Delbruck Center for Molecular Medicine Pipeline Products & Ongoing Clinical Trials Overview 138

Diagnostic Test – Raynaud’s Syndrome – Product Status 138

Diagnostic Test – Raynaud’s Syndrome – Product Description 138

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 139

Antibody Test – Multiple Sclerosis – Product Status 139

Antibody Test – Multiple Sclerosis – Product Description 139

Medica Corp Pipeline Products & Ongoing Clinical Trials Overview 140

EasyRA Analyzer – IgA Assay – Product Status 140

EasyRA Analyzer – IgA Assay – Product Description 140

EasyRA Analyzer – IgG Assay – Product Status 141

EasyRA Analyzer – IgG Assay – Product Description 141

EasyRA Analyzer – IgM Assay – Product Status 141

EasyRA Analyzer – IgM Assay – Product Description 142

Medical & Biological Laboratories Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

Anti-CADM-140 Autoantibodies Detection Kit – Product Status 143

Anti-CADM-140 Autoantibodies Detection Kit – Product Description 143

Metabiomics Corporation Pipeline Products & Ongoing Clinical Trials Overview 144

Microbiome Biomarker Test – Autoimmune Diseases – Product Status 144

Microbiome Biomarker Test – Autoimmune Diseases – Product Description 144

Microbiome Biomarker Test – Colitis – Product Status 145

Microbiome Biomarker Test – Colitis – Product Description 145

Microbiome Biomarker Test – Crohn’s Disease – Product Status 145

Microbiome Biomarker Test – Crohn’s Disease – Product Description 146

Metabolomic Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 147

CeliacDx – Product Status 147

CeliacDx – Product Description 147

ColitisDx – Product Status 148

ColitisDx – Product Description 148

CrohnsDx – Product Status 148

CrohnsDx – Product Description 149

IBDDx – Product Status 149

IBDDx – Product Description 149

Metanomics Health GmbH Pipeline Products & Ongoing Clinical Trials Overview 150

Diagnostic Assay – Multiple Sclerosis – Product Status 150

Diagnostic Assay – Multiple Sclerosis – Product Description 150

MSDx Inc Pipeline Products & Ongoing Clinical Trials Overview 151

WINDOW INTO THE BRAIN Test Panel – Multiple Sclerosis – Product Status 151

WINDOW INTO THE BRAIN Test Panel – Multiple Sclerosis – Product Description 151

Myriad Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 152

Diagnostic Assay – Juvenile Idiopathic Rheumatoid Arthritis – Product Status 152

Diagnostic Assay – Juvenile Idiopathic Rheumatoid Arthritis – Product Description 152

Nanosphere Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 153

Ultra-Sensitive Protein Assay – Autoimmune Disease – Product Status 153

Ultra-Sensitive Protein Assay – Autoimmune Disease – Product Description 153

Neuro Vigor LLC Pipeline Products & Ongoing Clinical Trials Overview 154

Acrolein Based Companion Diagnostic Assay – Multiple Sclerosis – Product Status 154

Acrolein Based Companion Diagnostic Assay – Multiple Sclerosis – Product Description 154

NoToPharm srl Pipeline Products & Ongoing Clinical Trials Overview 155

Diagnostic Assay – Dermatomyositis – Product Status 155

Diagnostic Assay – Dermatomyositis – Product Description 155

Diagnostic Assay – Mixed Connectivitis – Product Status 156

Diagnostic Assay – Mixed Connectivitis – Product Description 156

Diagnostic Assay – Polimyositis – Product Status 156

Diagnostic Assay – Polimyositis – Product Description 157

Diagnostic Assay – Sjogren Syndrome – Product Status 157

Diagnostic Assay – Sjogren Syndrome – Product Description 157

Diagnostic Assay – Systemic Lupus Erythematosus – Product Status 158

Diagnostic Assay – Systemic Lupus Erythematosus – Product Description 158

Diagnostic Assay – Systemic Sclerosis – Product Status 158

Diagnostic Assay – Systemic Sclerosis – Product Description 159

IFI16Ab Based Prognostic Assay – Product Status 159

IFI16Ab Based Prognostic Assay – Product Description 159

Numares AG Pipeline Products & Ongoing Clinical Trials Overview 160

Axinon – Multiple Sclerosis – Product Status 160

Axinon – Multiple Sclerosis – Product Description 160

OmniBiome Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 161

Pediatric Diagnostic Test – Autoimmune Disease – Product Status 161

Pediatric Diagnostic Test – Autoimmune Disease – Product Description 161

One Way Liver SL Pipeline Products & Ongoing Clinical Trials Overview 162

Diagnostic Test – Multiple Sclerosis – Product Status 162

Diagnostic Test – Multiple Sclerosis – Product Description 162

OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 163

Diagnostic Test – Multiple Sclerosis – Product Status 163

Diagnostic Test – Multiple Sclerosis – Product Description 163

Op-T-Mune Inc Pipeline Products & Ongoing Clinical Trials Overview 164

Screening Test – Multiple Sclerosis – Product Status 164

Screening Test – Multiple Sclerosis – Product Description 164

Oxford Biodynamics Plc Pipeline Products & Ongoing Clinical Trials Overview 165

EpiSwitch T2DM Prognostic Test – Product Status 165

EpiSwitch T2DM Prognostic Test – Product Description 165

Oxford Gene Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 166

OGT SLE Test – Product Status 166

OGT SLE Test – Product Description 166

Oxford Immunotec Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

Stratokine – Product Status 167

Stratokine – Product Description 167

Pediatric Bioscience LLC Pipeline Products & Ongoing Clinical Trials Overview 168

MAR Test – Product Status 168

MAR Test – Product Description 168

Penn State College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 169

Multiple Sclerosis Biomarker Test – Product Status 169

Multiple Sclerosis Biomarker Test – Product Description 169

Progentec Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 170

aiMS DX Disease Activity Test – Multiple Sclerosis – Product Status 170

aiMS DX Disease Activity Test – Multiple Sclerosis – Product Description 170

aiMS DX Interferon Treatment Response – Multiple Sclerosis – Product Status 171

aiMS DX Interferon Treatment Response – Multiple Sclerosis – Product Description 171

aiMS DX NMO Distinction – Neuromyelitis Optica – Product Status 171

aiMS DX NMO Distinction – Neuromyelitis Optica – Product Description 172

aiMS DX Relapse Prediction Test – Multiple Sclerosis – Product Status 172

aiMS DX Relapse Prediction Test – Multiple Sclerosis – Product Description 172

aiSLE DX Classification Test – Product Status 173

aiSLE DX Classification Test – Product Description 173

aiSLE DX Disease Activity Test – Product Status 173

aiSLE DX Disease Activity Test – Product Description 174

Biologic Biomarker – Crohn’s Disease / Ulcerative Colitis – Product Status 174

Biologic Biomarker – Crohn’s Disease / Ulcerative Colitis – Product Description 174

Diagnostic Test – Sjogren’s Syndrome – Product Status 175

Diagnostic Test – Sjogren’s Syndrome – Product Description 175

Prometheus Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 176

Companion Diagnostic Assay – Ulcerative Colitis – Product Status 176

Companion Diagnostic Assay – Ulcerative Colitis – Product Description 176

PRA052 Companion Diagnostic Assay – Product Status 177

PRA052 Companion Diagnostic Assay – Product Description 177

Prometheus Biosciences Inc – Ongoing Clinical Trials Overview 178

Companion Diagnostic Assay – Ulcerative Colitis – A Phase 2, Multi-center, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis 179

PRA052 Companion Diagnostic Assay – A Phase I, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetics Study of PRA052 in Healthy Volunteers 180

Protagen AG Pipeline Products & Ongoing Clinical Trials Overview 181

Diagnostic Assay – Ankylosing Spondylitis – Product Status 181

Diagnostic Assay – Ankylosing Spondylitis – Product Description 181

Diagnostic Assay – Juvenile Idiopathic Arthritis – Product Status 182

Diagnostic Assay – Juvenile Idiopathic Arthritis – Product Description 182

Diagnostic Assay – Multiple Sclerosis – Product Status 182

Diagnostic Assay – Multiple Sclerosis – Product Description 183

Diagnostic Assay – Neuromyelitis Optica – Product Status 183

Diagnostic Assay – Neuromyelitis Optica – Product Description 183

Multilisa SLE – Product Status 184

Multilisa SLE – Product Description 184

Multiplex Assay – Autoimmune Diseases – Product Status 184

Multiplex Assay – Autoimmune Diseases – Product Description 185

NavigAID – Sjogren’s Syndrome – Product Status 185

NavigAID – Sjogren’s Syndrome – Product Description 185

ProteinLogic Ltd Pipeline Products & Ongoing Clinical Trials Overview 186

ImmiPrint Diagnostic Test – Autoimmune Diseases – Product Status 186

ImmiPrint Diagnostic Test – Autoimmune Diseases – Product Description 186

Psyros Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 187

Psyros – Autoimmune Disease – Product Status 187

Psyros – Autoimmune Disease – Product Description 187

Quanterix Corp Pipeline Products & Ongoing Clinical Trials Overview 188

ADVIA Centaur sNFL Assay – Multiple Sclerosis – Product Status 188

ADVIA Centaur sNFL Assay – Multiple Sclerosis – Product Description 188

Digital ELISA – Crohn’s Disease – Product Status 189

Digital ELISA – Crohn’s Disease – Product Description 189

Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 190

Molecular Diagnostic Test – Multiple Sclerosis – Product Status 190

Molecular Diagnostic Test – Multiple Sclerosis – Product Description 190

Rappaport Family Institute for Research in the Medical Science Pipeline Products & Ongoing Clinical Trials Overview 191

Biomarker Test – Multiple Sclerosis – Product Status 191

Biomarker Test – Multiple Sclerosis – Product Description 191

Revvity Inc Pipeline Products & Ongoing Clinical Trials Overview 192

Accentis – Autoimmune Disorders – Product Status 192

Accentis – Autoimmune Disorders – Product Description 192

Roche Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 193

Roche Elecsys NfL Test – Product Status 193

Roche Elecsys NfL Test – Product Description 194

Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 195

Anti-IL17 Mab Companion Diagnostic Assay – Product Status 195

Anti-IL17 Mab Companion Diagnostic Assay – Product Description 195

Companion Diagnostic Test – Ocrelizumab – Product Status 196

Companion Diagnostic Test – Ocrelizumab – Product Description 196

IFN-Induced Genes Companion Diagnostic Test – Product Status 196

IFN-Induced Genes Companion Diagnostic Test – Product Description 197

Integrated Modular Analytics – IL-6 Test – Product Status 197

Integrated Modular Analytics – IL-6 Test – Product Description 197

Royal College of Surgeons Ireland Pipeline Products & Ongoing Clinical Trials Overview 198

Diagnostic Biomarker Assay – Maturity-Onset Of Diabetes Of The Young – Product Status 198

Diagnostic Biomarker Assay – Maturity-Onset Of Diabetes Of The Young – Product Description 198

Seattle Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 199

Biomarker Test – Juvenile Systemic Sclerosis – Product Status 199

Biomarker Test – Juvenile Systemic Sclerosis – Product Description 199

Genetic Test – Kawasaki Disease – Product Status 200

Genetic Test – Kawasaki Disease – Product Description 200

Sengenics Corp Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 201

Companion Diagnostic Test – Autoimmune Disease Drug 1 – Product Status 201

Companion Diagnostic Test – Autoimmune Disease Drug 1 – Product Description 201

Companion Diagnostic Test – Autoimmune Disease Drug 2 – Product Status 202

Companion Diagnostic Test – Autoimmune Disease Drug 2 – Product Description 202

Diagnostic Assay – Rheumatoid Arthritis – Product Status 202

Diagnostic Assay – Rheumatoid Arthritis – Product Description 203

Diagnostic Assay – Sjogren Syndrome – Product Status 203

Diagnostic Assay – Sjogren Syndrome – Product Description 203

Diagnostic Assay – Systemic Lupus Erythematosus – Product Status 204

Diagnostic Assay – Systemic Lupus Erythematosus – Product Description 204

Sequenom Inc Pipeline Products & Ongoing Clinical Trials Overview 205

AttoSense Lupus Panel – Product Status 205

AttoSense Lupus Panel – Product Description 205

Shuwen Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

Diagnostic Test – Autoimmune Diseases – Product Status 206

Diagnostic Test – Autoimmune Diseases – Product Description 206

SomaLogic Inc Pipeline Products & Ongoing Clinical Trials Overview 207

SomaSignal Test – Multiple Sclerosis – Product Status 207

SomaSignal Test – Multiple Sclerosis – Product Description 207

Southern Illinois University Carbondale Pipeline Products & Ongoing Clinical Trials Overview 208

Diagnostic Test – Crohn’s Disease – Product Status 208

Diagnostic Test – Crohn’s Disease – Product Description 208

Diagnostic Test – Ulcerative Colitis – Product Status 209

Diagnostic Test – Ulcerative Colitis – Product Description 209

Spanish National Research Council Pipeline Products & Ongoing Clinical Trials Overview 210

Diagnostic Assay – Rheumatoid Arthritis – Product Status 210

Diagnostic Assay – Rheumatoid Arthritis – Product Description 210

SQI Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 211

ANA Ig_plex 11-Plex Assay – Product Status 211

ANA Ig_plex 11-Plex Assay – Product Description 212

Autoimmune Thyroid Panel 3-Plex Assay – Product Status 212

Autoimmune Thyroid Panel 3-Plex Assay – Product Description 212

Ig_plex 9-Plex – Product Status 213

Ig_plex 9-Plex – Product Description 213

Ig_PLEX Lupus Panel Assay – Product Status 213

Ig_PLEX Lupus Panel Assay – Product Description 214

IgX PLEX Celiac Panel 6-Plex Assay – Product Status 214

IgX PLEX Celiac Panel 6-Plex Assay – Product Description 214

Vasculitis Ig_PLEX 3-Plex – Product Status 215

Vasculitis Ig_PLEX 3-Plex – Product Description 215

Statens Serum Institut Pipeline Products & Ongoing Clinical Trials Overview 216

Diagnostic Test – Systemic Autoimmune Disease – Product Status 216

Diagnostic Test – Systemic Autoimmune Disease – Product Description 216

Sugentech Inc Pipeline Products & Ongoing Clinical Trials Overview 217

Diagnostic Test – Autoimmune Disease – Product Status 217

Diagnostic Test – Autoimmune Disease – Product Description 217

Svar Life Science AB Pipeline Products & Ongoing Clinical Trials Overview 218

Diagnostic Test – Autoimmune Disorders – Product Status 218

Diagnostic Test – Autoimmune Disorders – Product Description 218

TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 219

TBG Kit – Autoimmune Disease – Product Status 219

TBG Kit – Autoimmune Disease – Product Description 219

Tel Aviv University Pipeline Products & Ongoing Clinical Trials Overview 220

Diagnostic Kit – Chronic Kidney Disease – Product Status 220

Diagnostic Kit – Chron

Figures

Auto-Immune Diseases – Pipeline Products by Stage of Development 23

Auto-Immune Diseases – Pipeline Products by Territory 24

Auto-Immune Diseases – Pipeline Products by Regulatory Path 25

Auto-Immune Diseases – Pipeline Products by Estimated Approval Date 26

Auto-Immune Diseases – Ongoing Clinical Trials 27

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