Auto-Immune Diseases Diagnostic Tests - Medical Devices Pipeline Assessment, 2018

2018-04-01
Price :
Published : Apr-2018
No. of Pages : 331
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 15
2 Introduction 16
2.1 Auto-Immune Diseases Overview 16
3 Products under Development 17
3.1 Auto-Immune Diseases - Pipeline Products by Stage of Development 17
3.2 Auto-Immune Diseases - Pipeline Products by Territory 18
3.3 Auto-Immune Diseases - Pipeline Products by Regulatory Path 19
3.4 Auto-Immune Diseases - Pipeline Products by Estimated Approval Date 20
3.5 Auto-Immune Diseases - Ongoing Clinical Trials 21
4 Auto-Immune Diseases - Pipeline Products under Development by Companies 22
4.1 Auto-Immune Diseases Companies - Pipeline Products by Stage of Development 22
4.2 Auto-Immune Diseases - Pipeline Products by Stage of Development 26
5 Auto-Immune Diseases Companies and Product Overview 32
5.1 Immunarray Pvt Ltd Company Overview 32
5.2 Adaptive Biotechnologies Corp Company Overview 35
5.3 Albert Ludwigs University of Freiburg Company Overview 37
5.4 Alere Inc Company Overview 39
5.5 Amarantus Diagnostics Inc Company Overview 41
5.6 apDia nv Company Overview 43
5.7 Autoimmune Technologies LLC Company Overview 44
5.8 Beckman Coulter Inc Company Overview 48
5.9 BG Medicine Inc Company Overview 49
5.10 Biogen Inc Company Overview 50
5.11 Biomedal SL Company Overview 51
5.12 Bionure Farma SL Company Overview 53
5.13 CDI Laboratories Inc Company Overview 54
5.14 Chronix Biomedical Inc Company Overview 55
5.15 Crescendo Bioscience Inc Company Overview 57
5.16 Digna Biotech SL Company Overview 60
5.17 DNAlytics Company Overview 62
5.18 EMD Millipore Corp Company Overview 65
5.19 Enable Biosciences Inc Company Overview 66
5.20 Enterome Bioscience SA Company Overview 67
5.21 Ezose Sciences Inc. Company Overview 69
5.22 Flamentera AG Company Overview 70
5.23 Genalyte Inc Company Overview 71
5.24 GeNeuro SA Company Overview 72
5.25 Grifols SA Company Overview 73
5.26 Hannover Medical School Company Overview 74
5.27 Helmholtz Centre for Infection Research Company Overview 75
5.28 HOB Biotech Group Suzhou Co Ltd Company Overview 76
5.29 Hospital for Special Surgery Company Overview 77
5.30 Hycor Biomedical Inc Company Overview 78
5.31 Ignyta Inc Company Overview 80
5.32 Immunovia AB Company Overview 82
5.33 ImmusanT Inc Company Overview 84
5.34 Innobiochips Company Overview 86
5.35 Inova Diagnostics Inc Company Overview 87
5.36 Iron Horse Diagnostics, Inc. Company Overview 91
5.37 Johns Hopkins University Company Overview 93
5.38 LineaGen Inc Company Overview 95
5.39 Lophius Biosciences GmbH Company Overview 96
5.40 Louisville Bioscience, Inc. Company Overview 97
5.41 Max Delbruck Center for Molecular Medicine Company Overview 100
5.42 Medica Corp Company Overview 101
5.43 Metabiomics Corporation Company Overview 103
5.44 Metabolomic Technologies Inc Company Overview 105
5.45 Metanomics Health GmbH Company Overview 108
5.46 MSDx Inc Company Overview 109
5.47 Myriad Genetics Inc Company Overview 110
5.48 Nanosphere Inc Company Overview 111
5.49 Neuro Vigor LLC Company Overview 112
5.50 Northwestern University Company Overview 113
5.51 NoToPharm srl Company Overview 114
5.52 Numares AG Company Overview 119
5.53 OmniBiome Therapeutics Inc Company Overview 120
5.54 One Way Liver SL Company Overview 121
5.55 OPKO Health Inc Company Overview 122
5.56 Oxford Gene Technology Ltd Company Overview 123
5.57 Oxford Immunotec Ltd Company Overview 124
5.58 Pediatric Bioscience, LLC Company Overview 125
5.59 Progentec Diagnostics, Inc. Company Overview 126
5.60 Protagen AG Company Overview 127
5.61 ProteinLogic Ltd Company Overview 131
5.62 Quanterix Corp Company Overview 132
5.63 Rambam Health Care Campus Company Overview 133
5.64 Rappaport Family Institute for Research in the Medical Science Company Overview 134
5.65 Regulus Therapeutics Inc Company Overview 135
5.66 Roche Diagnostics International Ltd Company Overview 136
5.67 Seattle Children's Hospital Company Overview 140
5.68 Sengenics International Pte Ltd Company Overview 141
5.69 Sequenom Inc Company Overview 143
5.70 Shuwen Biotech Co Ltd Company Overview 144
5.71 SomaLogic Inc Company Overview 145
5.72 Southern Illinois University Carbondale Company Overview 146
5.73 SQI Diagnostics Inc Company Overview 148
5.74 Statens Serum Institut Company Overview 153
5.75 TBG Diagnostics Ltd Company Overview 154
5.76 The Walter and Eliza Hall Institute of Medical Research Company Overview 155
5.77 Thermo Fisher Scientific Inc Company Overview 156
5.78 Toscana Biomarkers Srl Company Overview 170
5.79 University Health Network Company Overview 173
5.80 University of California San Francisco Company Overview 174
5.81 University of Chicago Company Overview 175
5.82 University of Colorado Company Overview 176
5.83 University of Houston Company Overview 177
5.84 University of Illinois at Chicago Company Overview 178
5.85 University of Manchester Company Overview 179
5.86 University of Maryland Baltimore Company Overview 181
5.87 University of Missouri Company Overview 182
5.88 University of Oxford Company Overview 183
5.89 University of Pecs Company Overview 185
5.90 University of Southern California Company Overview 186
5.91 University Rovira i Virgili Company Overview 187
5.92 US Biomarkers Inc Company Overview 188
5.93 Washington University in St Louis Company Overview 189
5.94 XEPTAGEN SpA Company Overview 190
5.95 Yale University Company Overview 191
6 Auto-Immune Diseases- Recent Developments 192
6.1 Mar 16, 2018: Thermo Fisher Scientific Announces Plans to Build State-Of-The-Art Pharma Services Facility in Rheinfelden 192
6.2 Mar 07, 2018: Regulus Reports Fourth Quarter and Year-end 2017 Financial Results and Pipeline Update 192
6.3 Mar 07, 2018: Trinity Biotech announces Quarter 4 and Fiscal Year 2017 Financial Results 193
6.4 Mar 01, 2018: OPKO Health Reports 2017 Fourth Quarter Business Highlights and Financial Results 196
6.5 Mar 01, 2018: Oxford Immunotec Announces Appointment of Mark Klausner to the Board of Directors 197
6.6 Feb 27, 2018: Oxford Immunotec Reports Fourth Quarter and Full Year 2017 Financial Results 198
6.7 Feb 27, 2018: Bio-Rad Reports Fourth-Quarter and Full-Year 2017 Financial Results 200
6.8 Feb 20, 2018: Theradiag Announces 2017 Annual Sales and Cash Flow at End 2017 201
6.9 Feb 15, 2018: Immunovia Full Year report, January-December 2017 202
6.10 Feb 13, 2018: Adaptive Biotechnologies Appoints Veteran Molecular Diagnostics Executive Michael Pellini, MD, to Board of Directors 203
6.11 Feb 12, 2018: Luminex Reports Fourth Quarter and Full-Year 2017 Financial Results 203
6.12 Feb 06, 2018: Myriad Genetics Reports Fiscal Second-Quarter 2018 Financial Results 204
6.13 Feb 05, 2018: CyPass Ushers in Exciting New Era of Glaucoma Treatment 205
6.14 Feb 05, 2018: SQI Diagnostics Reports First Quarter 2018 Results 206
6.15 Jan 31, 2018: Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2017 Results 207
6.16 Jan 31, 2018: QIAGEN Reports Results for Fourth Quarter and Full-year 2017, Announces STAT-Dx Acquisition and New $200 Million Share Repurchase 209
6.17 Jan 31, 2018: Thermo Fisher Scientific Uses Tax Reform Benefit to Make Additional Investments in Colleagues, Customers and Communities 214
6.18 Jan 30, 2018: Siemens Healthineers Names Deepak Nath Head of Laboratory Diagnostics 215
6.19 Jan 26, 2018: OPKO Health Announces Resignation Of Gregory Henderson As President Of BioReference Laboratories 215
6.20 Jan 24, 2018: Genalyte Receives ISO 13485 Medical Device Manufacturing Certification 215
6.21 Jan 16, 2018: Avi Pelossof Appointed President and CEO of Immucor 216
6.22 Jan 16, 2018: Biomerica Announces Second Quarter Financial Results; Sales Up 12.7% for the Quarter 216
6.23 Jan 08, 2018: CareDx Reports Preliminary Fourth Quarter and FY2017 Financial Results 217
6.24 Jan 03, 2018: Inova Diagnostics Receives FDA Clearance for the First Fully Automated, Random Access Calprotectin Test 217
6.25 Jan 03, 2018: Genalyte to Offer Patient Testing & Demonstration of its Diagnostic Cloud Lab in San Francisco January 7-11 218
7 Appendix 326
7.1 Methodology 326
7.2 About GlobalData 329
7.3 Contact Us 329
7.4 Disclaimer 329

1.1 List of Tables
Table 1: Auto-Immune Diseases - Pipeline Products by Stage of Development 19
Table 2: Auto-Immune Diseases - Pipeline Products by Territory 20
Table 3: Auto-Immune Diseases - Pipeline Products by Regulatory Path 21
Table 4: Auto-Immune Diseases - Pipeline Products by Estimated Approval Date 22
Table 5: Auto-Immune Diseases - Ongoing Clinical Trials 23
Table 6: Auto-Immune Diseases Companies - Pipeline Products by Stage of Development 24
Table 7: Auto-Immune Diseases - Pipeline Products by Stage of Development 28
Table 8: Immunarray Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 34
Table 9: SLE-Key Rule-Out Test - Product Status 34
Table 10: SLE-Key Rule-Out Test - Product Description 34
Table 11: Immunarray Pvt Ltd - Ongoing Clinical Trials Overview 35
Table 12: SLE-Key Rule-Out Test - Clinical Trial to Support the Clinical Implementation of ImmunArray's SLE-Key Rule-Out Test 36
Table 13: Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 37
Table 14: Non-Invasive Diagnostic Test - Celiac Disease - Product Status 37
Table 15: Non-Invasive Diagnostic Test - Celiac Disease - Product Description 37
Table 16: Pre - Symptomatic Biomarker - Type 1 Diabetes - Product Status 38
Table 17: Pre - Symptomatic Biomarker - Type 1 Diabetes - Product Description 38
Table 18: Albert Ludwigs University of Freiburg Pipeline Products & Ongoing Clinical Trials Overview 39
Table 19: Biomarker Based Assay - Systemic Sclerosis - Product Status 39
Table 20: Biomarker Based Assay - Systemic Sclerosis - Product Description 39
Table 21: Mitochondrial DNA Based Assay - Autoimmune and Autoinflammatory Diseases - Product Status 40
Table 22: Mitochondrial DNA Based Assay - Autoimmune and Autoinflammatory Diseases - Product Description 40
Table 23: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 24: AIMS System - Cardiolipin IgG Test - Product Status 41
Table 25: AIMS System - Cardiolipin IgG Test - Product Description 41
Table 26: AtheNA Multi-Lyte System - Cardiolipin IgG Test - Product Status 42
Table 27: AtheNA Multi-Lyte System - Cardiolipin IgG Test - Product Description 42
Table 28: Amarantus Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 43
Table 29: Diagnostic Assay - Neuromyelitis Optica - Product Status 43
Table 30: Diagnostic Assay - Neuromyelitis Optica - Product Description 43
Table 31: Diagnostic Assay - Paraneoplastic Disease - Product Status 44
Table 32: Diagnostic Assay - Paraneoplastic Disease - Product Description 44
Table 33: apDia nv Pipeline Products & Ongoing Clinical Trials Overview 45
Table 34: Diagnostic Test - MS (Multiple Sclerosis) - Product Status 45
Table 35: Diagnostic Test - MS (Multiple Sclerosis) - Product Description 45
Table 36: Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 46
Table 37: Anti-Squalene Antibody Assay - Product Status 46
Table 38: Anti-Squalene Antibody Assay - Product Description 46
Table 39: Autoimmune Disease Virus Assay - Graves' Disease - Product Status 47
Table 40: Autoimmune Disease Virus Assay - Graves' Disease - Product Description 47
Table 41: Autoimmune Disease Virus Assay - Juvenile Rheumatoid Arthritis - Product Status 47
Table 42: Autoimmune Disease Virus Assay - Juvenile Rheumatoid Arthritis - Product Description 48
Table 43: Autoimmune Disease Virus Assay - Sjogren Syndrome - Product Status 48
Table 44: Autoimmune Disease Virus Assay - Sjogren Syndrome - Product Description 48
Table 45: Autoimmune Disease Virus Assay - Systemic Lupus Erythematosus - Product Status 49
Table 46: Autoimmune Disease Virus Assay - Systemic Lupus Erythematosus - Product Description 49
Table 47: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 50
Table 48: SYNCHRON LXi 725 Anti-dsDNA Assay - Product Status 50
Table 49: SYNCHRON LXi 725 Anti-dsDNA Assay - Product Description 50
Table 50: BG Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 51
Table 51: Diagnostic Assay - Multiple Sclerosis - Product Status 51
Table 52: Diagnostic Assay - Multiple Sclerosis - Product Description 51
Table 53: Biogen Inc Pipeline Products & Ongoing Clinical Trials Overview 52
Table 54: Companion Diagnostic Test - Sjogren's Syndrome - Product Status 52
Table 55: Companion Diagnostic Test - Sjogren's Syndrome - Product Description 52
Table 56: Biomedal SL Pipeline Products & Ongoing Clinical Trials Overview 53
Table 57: ELISA DELIAC GFD - Product Status 53
Table 58: ELISA DELIAC GFD - Product Description 53
Table 59: IVYLISA DGP8 - Product Status 54
Table 60: IVYLISA DGP8 - Product Description 54
Table 61: Stick DELIAC GFD - Product Status 54
Table 62: Stick DELIAC GFD - Product Description 54
Table 63: Bionure Farma SL Pipeline Products & Ongoing Clinical Trials Overview 55
Table 64: BN - 301 Diagnostic/Prognostic Test - Product Status 55
Table 65: BN - 301 Diagnostic/Prognostic Test - Product Description 55
Table 66: CDI Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 56
Table 67: Diagnostic Test - Systemic Lupus Erythematosus - Product Status 56
Table 68: Diagnostic Test - Systemic Lupus Erythematosus - Product Description 56
Table 69: Chronix Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 57
Table 70: Companion Diagnostic Test - Multiple Sclerosis - Product Status 57
Table 71: Companion Diagnostic Test - Multiple Sclerosis - Product Description 57
Table 72: Diagnostic Test - Systemic Lupus Erythematous - Product Status 58
Table 73: Diagnostic Test - Systemic Lupus Erythematous - Product Description 58
Table 74: Crescendo Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 59
Table 75: Multi-Biomarker Test - Ankylosing Spondylitis - Product Status 59
Table 76: Multi-Biomarker Test - Ankylosing Spondylitis - Product Description 59
Table 77: Multi-Biomarker Test - Autoimmune Diseases - Product Status 60
Table 78: Multi-Biomarker Test - Autoimmune Diseases - Product Description 60
Table 79: Multi-Biomarker Test - Psoriatic Arthritis - Product Status 60
Table 80: Multi-Biomarker Test - Psoriatic Arthritis - Product Description 60
Table 81: Multi-Biomarker Test - Systemic Lupus Erythematosus - Product Status 61
Table 82: Multi-Biomarker Test - Systemic Lupus Erythematosus - Product Description 61
Table 83: Digna Biotech SL Pipeline Products & Ongoing Clinical Trials Overview 62
Table 84: Anti-CD-137 Antibodies Assay - Product Status 62
Table 85: Anti-CD-137 Antibodies Assay - Product Description 62
Table 86: Prognostic Test - Multiple Sclerosis - Product Status 63
Table 87: Prognostic Test - Multiple Sclerosis - Product Description 63
Table 88: DNAlytics Pipeline Products & Ongoing Clinical Trials Overview 64
Table 89: RheumaKit-Tx - Product Status 64
Table 90: RheumaKit-Tx - Product Description 64
Table 91: DNAlytics - Ongoing Clinical Trials Overview 65
Table 92: RheumaKit-Tx - Prediction of the Response to Anti-TNFs DMARDs Based on the RheumaKit Platform (RK-Tx-01) 66
Table 93: EMD Millipore Corp Pipeline Products & Ongoing Clinical Trials Overview 67
Table 94: Erenna IL-12 Immunoassay Kit - Product Status 67
Table 95: Erenna IL-12 Immunoassay Kit - Product Description 67
Table 96: Enable Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 68
Table 97: ADAP Autoimmune Disease Assay - Product Status 68
Table 98: ADAP Autoimmune Disease Assay - Product Description 68
Table 99: Enterome Bioscience SA Pipeline Products & Ongoing Clinical Trials Overview 69
Table 100: Diagnostic Test - Multiple Sclerosis - Product Status 69
Table 101: Diagnostic Test - Multiple Sclerosis - Product Description 69
Table 102: Diagnostic Test - Type 2 Diabetes - Product Status 70
Table 103: Diagnostic Test - Type 2 Diabetes - Product Description 70
Table 104: Ezose Sciences Inc. Pipeline Products & Ongoing Clinical Trials Overview 71
Table 105: Biomarker Diagnostic Assay - Multiple Sclerosis - Product Status 71
Table 106: Biomarker Diagnostic Assay - Multiple Sclerosis - Product Description 71
Table 107: Flamentera AG Pipeline Products & Ongoing Clinical Trials Overview 72

1.2 List of Figures
Figure 1: Auto-Immune Diseases - Pipeline Products by Stage of Development 19
Figure 2: Auto-Immune Diseases - Pipeline Products by Territory 20
Figure 3: Auto-Immune Diseases - Pipeline Products by Regulatory Path 21
Figure 4: Auto-Immune Diseases - Pipeline Products by Estimated Approval Date 22
Figure 5: Auto-Immune Diseases - Ongoing Clinical Trials 23
Filed in: Pharmaceutical
Publisher : GlobalData