Published : Oct-2017
No. of Pages : 382
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 17
2 Introduction 18
2.1 Auto-Immune Diseases Diagnostic Tests Overview 18
3 Products under Development 19
3.1 Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Stage of Development 19
3.2 Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Territory 20
3.3 Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Regulatory Path 21
3.4 Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Estimated Approval Date 22
3.5 Auto-Immune Diseases Diagnostic Tests - Ongoing Clinical Trials 23
4 Auto-Immune Diseases Diagnostic Tests - Pipeline Products under Development by Companies 24
4.1 Auto-Immune Diseases Diagnostic Tests Companies - Pipeline Products by Stage of Development 24
4.2 Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Stage of Development 28
5 Auto-Immune Diseases Diagnostic Tests Companies and Product Overview 34
5.1 Adaptive Biotechnologies Corp Company Overview 34
5.2 Agena Bioscience, Inc Company Overview 37
5.3 Albert Ludwigs University of Freiburg Company Overview 38
5.4 Alere Inc Company Overview 41
5.5 Amarantus Bioscience Holdings Inc Company Overview 43
5.6 Analyticon Biotechnologies AG Company Overview 45
5.7 apDia nv Company Overview 46
5.8 Autoimmune Technologies LLC Company Overview 47
5.9 Banyan Biomarkers Inc Company Overview 51
5.10 Beckman Coulter Inc Company Overview 52
5.11 BG Medicine Inc Company Overview 53
5.12 Biocortech SAS Company Overview 54
5.13 Biogen Inc Company Overview 55
5.14 Biomedal SL Company Overview 56
5.15 Biomerica, Inc. Company Overview 58
5.16 Bionure Farma SL Company Overview 59
5.17 CD Diagnostics, Inc. Company Overview 60
5.18 CDI Laboratories Inc Company Overview 61
5.19 Chronix Biomedical Inc Company Overview 62
5.20 Cincinnati Children's Hospital Medical Center Company Overview 64
5.21 Co-Diagnostics HBDC, Inc. Company Overview 65
5.22 Cofactor Genomics Inc Company Overview 66
5.23 Crescendo Bioscience Inc Company Overview 68
5.24 Digna Biotech SL Company Overview 72
5.25 Durin Technologies, Inc. Company Overview 74
5.26 EMD Millipore Corp Company Overview 75
5.27 Enterome Bioscience SA Company Overview 76
5.28 Ezose Sciences Inc. Company Overview 78
5.29 Flamentera AG Company Overview 79
5.30 French National Institute of Health and Medical Research Company Overview 80
5.31 Genalyte, Inc. Company Overview 81
5.32 GeNeuro SA Company Overview 82
5.33 Glycominds Ltd. Company Overview 83
5.34 Grifols SA Company Overview 84
5.35 Hannover Medical School Company Overview 85
5.36 Helmholtz Centre for Infection Research Company Overview 86
5.37 HOB Biotech Group Suzhou Co Ltd Company Overview 87
5.38 Hospital for Special Surgery Company Overview 88
5.39 Hummingbird Diagnostics GmbH Company Overview 89
5.40 Hycor Biomedical Inc Company Overview 91
5.41 Ignyta Inc Company Overview 93
5.42 IMMUNARRAY LTD. Company Overview 96
5.43 Immunovia AB Company Overview 99
5.44 ImmusanT Inc Company Overview 100
5.45 Inflammatix Inc Company Overview 102
5.46 Innobiochips Company Overview 103
5.47 Inova Diagnostics Inc Company Overview 104
5.48 Iquity Labs Inc Company Overview 110
5.49 Iron Horse Diagnostics, Inc. Company Overview 112
5.50 Is Diagnostics Company Overview 114
5.51 John Hopkins University Company Overview 115
5.52 LineaGen Inc Company Overview 117
5.53 Lophius Biosciences GmbH Company Overview 118
5.54 Louisville Bioscience, Inc. Company Overview 119
5.55 Max-Delbruck-Centrum fur Molekulare Medizin (MDC) Company Overview 123
5.56 Medica Corp Company Overview 124
5.57 Metabiomics Corporation Company Overview 127
5.58 Metabolomic Technologies Inc Company Overview 129
5.59 Metanomics Health GmbH Company Overview 132
5.60 MSDx Inc Company Overview 133
5.61 Myriad Genetics Inc Company Overview 137
5.62 Nanosphere Inc Company Overview 138
5.63 Neuro Vigor LLC Company Overview 139
5.64 Northwestern University Company Overview 140
5.65 NoToPharm srl Company Overview 141
5.66 Numares AG Company Overview 146
5.67 OmniBiome Therapeutics Inc (Inactive) Company Overview 147
5.68 One Way Liver SL Company Overview 148
5.69 OPKO Health Inc Company Overview 149
5.70 Oxford Gene Technology Ltd Company Overview 150
5.71 Oxford Immunotec Ltd Company Overview 151
5.72 Pediatric Bioscience, LLC Company Overview 152
5.73 Progentec Diagnostics, Inc. Company Overview 153
5.74 Protagen AG Company Overview 154
5.75 ProteinLogic Ltd Company Overview 159
5.76 Quanterix Corp Company Overview 160
5.77 Rambam Health Care Campus Company Overview 161
5.78 Ramon y Cajal Institute of Health Research Company Overview 162
5.79 Rappaport Family Institute for Research in the Medical Science Company Overview 163
5.80 Regulus Therapeutics Inc Company Overview 164
5.81 Roche Diagnostics International Ltd Company Overview 165
5.82 Shuwen Biotech Co Ltd Company Overview 169
5.83 Siemens Healthcare GmbH Company Overview 170
5.84 SomaLogic Inc Company Overview 171
5.85 Southern Illinois University Carbondale Company Overview 172
5.86 SQI Diagnostics Inc Company Overview 174
5.87 Statens Serum Institut Company Overview 179
5.88 TBG Diagnostics Ltd Company Overview 180
5.89 The Walter and Eliza Hall Institute of Medical Research Company Overview 181
5.90 TheraDiag SA Company Overview 182
5.91 Thermo Fisher Scientific Inc Company Overview 184
5.92 Toscana Biomarkers Srl Company Overview 198
5.93 University Health Network Company Overview 202
5.94 University of California San Francisco Company Overview 203
5.95 University of Chicago Company Overview 204
5.96 University of Colorado Company Overview 205
5.97 University of Gottingen Company Overview 206
5.98 University of Illinois at Chicago Company Overview 208
5.99 University of Manchester Company Overview 209
5.100 University of Maryland Baltimore Company Overview 211
5.101 University of Missouri Company Overview 212
5.102 University of Oxford Company Overview 213
5.103 University of Pecs Company Overview 216
5.104 University of Southern California Company Overview 217
5.105 University Rovira i Virgili Company Overview 218
5.106 US Biomarkers Inc Company Overview 219
5.107 Washington University in St Louis Company Overview 220
5.108 XEPTAGEN SpA Company Overview 221
5.109 Yale University Company Overview 222
6 Auto-Immune Diseases Diagnostic Tests - Recent Developments 223
6.1 Sep 06, 2017: Sandra Cole Appointed Vice President and Chief Compliance Officer for OPKO's BioReference Laboratories 223
6.2 Aug 24, 2017: SQI Diagnostics Reports Third Quarter 2017 Results 223
6.3 Aug 17, 2017: Victoria Laughman Named Executive Vice President of Sales for OPKO's BioReference Laboratories 225
6.4 Aug 15, 2017: Ms. Teresa Regan Joins Neon Therapeutics as VP of Human Resources 226
6.5 Aug 10, 2017: CareDx Reports Second Quarter 2017 Financial Results 226
6.6 Aug 07, 2017: Luminex Reports Second Quarter 2017 Financial Results 227
6.7 Aug 03, 2017: Alere Reports Second Quarter 2017 Financial Results 228
6.8 Aug 03, 2017: Bio-Rad Reports Second-Quarter 2017 Financial Results 228
6.9 Aug 03, 2017: Diasorin Group Reports Strong Growth in Revenues and Profitability in Q2 2017 229
6.10 Aug 01, 2017: Regulus Reports Second Quarter 2017 Financial Results and Recent Events 233
6.11 Jul 31, 2017: GeNeuro Updates on Cash, Revenue and Activities at Q2 2017 233
6.12 Jul 28, 2017: Grifols increases its revenues by 12.3% to EUR 2,192 million driven by growth of its main divisions 234
6.13 Jul 27, 2017: Adaptive Biotechnologies Expands Leadership to Bolster Integration of Immune Profiling into Clinical Care Setting 241
6.14 Jul 27, 2017: QIAGEN Reports Results for Second Quarter and First Half of 2017 241
6.15 Jul 26, 2017: Thermo Fisher Scientific Reports Second Quarter 2017 Results 245
6.16 Jul 25, 2017: Theradiag: Further Strong Sales Growth in the First Half of 2017: +9% 247
6.17 Jul 20, 2017: Trinity Biotech Announces Results for Q2, 2017 247
6.18 Jul 18, 2017: Quanterix Boosts Investments in its Accelerator Lab to Support Rapid Growth of Simoa Technology 249
6.19 Jul 17, 2017: Leading pancreatic cancer expert on early symptoms Professor Stephen Pereira at University College London joins Immunovia's Scientific Advisory Board 250
6.20 Jul 13, 2017: Dr. Jaymie Sawyer, Vice President of R&D, Transitions to Lead Scientific Advisory Committee 250
6.21 Jul 12, 2017: Enterome Appoints Mary Thistle to its Board of Directors 250
7 Appendix 377
7.1 Methodology 377
7.2 About GlobalData 380
7.3 Contact Us 380
7.4 Disclaimer 380
1.1 List of Tables
Table 1: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Stage of Development 21
Table 2: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Territory 22
Table 3: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Regulatory Path 23
Table 4: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Estimated Approval Date 24
Table 5: Auto-Immune Diseases Diagnostic Tests - Ongoing Clinical Trials 25
Table 6: Auto-Immune Diseases Companies - Pipeline Products by Stage of Development 26
Table 7: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Stage of Development 30
Table 8: Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 36
Table 9: Diagnostic Test - Auto-Immune Disease - Product Status 36
Table 10: Diagnostic Test - Auto-Immune Disease - Product Description 36
Table 11: Non-Invasive Diagnostic Test - Celiac Disease - Product Status 37
Table 12: Non-Invasive Diagnostic Test - Celiac Disease - Product Description 37
Table 13: Pre - Symptomatic Biomarker - Type 1 Diabetes - Product Status 37
Table 14: Pre - Symptomatic Biomarker - Type 1 Diabetes - Product Description 38
Table 15: Agena Bioscience, Inc Pipeline Products & Ongoing Clinical Trials Overview 39
Table 16: AttoSense Lupus Panel - Product Status 39
Table 17: AttoSense Lupus Panel - Product Description 39
Table 18: Albert Ludwigs University of Freiburg Pipeline Products & Ongoing Clinical Trials Overview 40
Table 19: Biomarker Based Assay - Systemic Sclerosis - Product Status 40
Table 20: Biomarker Based Assay - Systemic Sclerosis - Product Description 40
Table 21: Circulating mtDNA Based Assay - Autoimmune and Autoinflammatory Diseases - Product Status 41
Table 22: Circulating mtDNA Based Assay - Autoimmune and Autoinflammatory Diseases - Product Description 41
Table 23: Mitochondrial DNA Based Assay - Autoimmune and Autoinflammatory Diseases - Product Status 41
Table 24: Mitochondrial DNA Based Assay - Autoimmune and Autoinflammatory Diseases - Product Description 42
Table 25: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 43
Table 26: AIMS System - Cardiolipin IgG Test - Product Status 43
Table 27: AIMS System - Cardiolipin IgG Test - Product Description 43
Table 28: AtheNA Multi-Lyte System - Cardiolipin IgG Test - Product Status 44
Table 29: AtheNA Multi-Lyte System - Cardiolipin IgG Test - Product Description 44
Table 30: Amarantus Bioscience Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 45
Table 31: Diagnostic Assay - Neuromyelitis Optica - Product Status 45
Table 32: Diagnostic Assay - Neuromyelitis Optica - Product Description 45
Table 33: Diagnostic Assay - Paraneoplastic Disease - Product Status 46
Table 34: Diagnostic Assay - Paraneoplastic Disease - Product Description 46
Table 35: Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 47
Table 36: Turbitex IgA - Product Status 47
Table 37: Turbitex IgA - Product Description 47
Table 38: apDia nv Pipeline Products & Ongoing Clinical Trials Overview 48
Table 39: Diagnostic Test - MS (Multiple Sclerosis) - Product Status 48
Table 40: Diagnostic Test - MS (Multiple Sclerosis) - Product Description 48
Table 41: Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 49
Table 42: Anti-Squalene Antibody Assay - Product Status 49
Table 43: Anti-Squalene Antibody Assay - Product Description 49
Table 44: Autoimmune Disease Virus Assay - Graves' Disease - Product Status 50
Table 45: Autoimmune Disease Virus Assay - Graves' Disease - Product Description 50
Table 46: Autoimmune Disease Virus Assay - Juvenile Rheumatoid Arthritis - Product Status 50
Table 47: Autoimmune Disease Virus Assay - Juvenile Rheumatoid Arthritis - Product Description 51
Table 48: Autoimmune Disease Virus Assay - Sjogren Syndrome - Product Status 51
Table 49: Autoimmune Disease Virus Assay - Sjogren Syndrome - Product Description 51
Table 50: Autoimmune Disease Virus Assay - Systemic Lupus Erythematosus - Product Status 52
Table 51: Autoimmune Disease Virus Assay - Systemic Lupus Erythematosus - Product Description 52
Table 52: Banyan Biomarkers Inc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 53: Diagnostic Assay - Parkinson's Disease - Product Status 53
Table 54: Diagnostic Assay - Parkinson's Disease - Product Description 53
Table 55: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 54
Table 56: SYNCHRON LXi 725 Anti-dsDNA Assay - Product Status 54
Table 57: SYNCHRON LXi 725 Anti-dsDNA Assay - Product Description 54
Table 58: BG Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 55
Table 59: Diagnostic Assay - Multiple Sclerosis - Product Status 55
Table 60: Diagnostic Assay - Multiple Sclerosis - Product Description 55
Table 61: Biocortech SAS Pipeline Products & Ongoing Clinical Trials Overview 56
Table 62: Blood Test - Cognitive Deficits - Product Status 56
Table 63: Blood Test - Cognitive Deficits - Product Description 56
Table 64: Biogen Inc Pipeline Products & Ongoing Clinical Trials Overview 57
Table 65: Companion Diagnostic Test - Sjogren's Syndrome - Product Status 57
Table 66: Companion Diagnostic Test - Sjogren's Syndrome - Product Description 57
Table 67: Biomedal SL Pipeline Products & Ongoing Clinical Trials Overview 58
Table 68: ELISA DELIAC GFD - Product Status 58
Table 69: ELISA DELIAC GFD - Product Description 58
Table 70: IVYLISA DGP8 - Product Status 59
Table 71: IVYLISA DGP8 - Product Description 59
Table 72: Stick DELIAC GFD - Product Status 59
Table 73: Stick DELIAC GFD - Product Description 59
Table 74: Biomerica, Inc. Pipeline Products & Ongoing Clinical Trials Overview 60
Table 75: Transglutaminase Elisa Kit - Product Status 60
Table 76: Transglutaminase Elisa Kit - Product Description 60
Table 77: Bionure Farma SL Pipeline Products & Ongoing Clinical Trials Overview 61
Table 78: BN - 301 Diagnostic/Prognostic Test - Product Status 61
Table 79: BN - 301 Diagnostic/Prognostic Test - Product Description 61
Table 80: CD Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 62
Table 81: Cygnasure Diagnostic Immunoassay - Lupus - Product Status 62
Table 82: Cygnasure Diagnostic Immunoassay - Lupus - Product Description 62
Table 83: CDI Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 63
Table 84: Diagnostic Test - Systemic Lupus Erythematosus - Product Status 63
Table 85: Diagnostic Test - Systemic Lupus Erythematosus - Product Description 63
Table 86: Chronix Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 64
Table 87: Companion Diagnostic Test - Multiple Sclerosis - Product Status 64
Table 88: Companion Diagnostic Test - Multiple Sclerosis - Product Description 64
Table 89: Companion Diagnostic Test - Systemic Lupus Erythematous - Product Status 65
Table 90: Companion Diagnostic Test - Systemic Lupus Erythematous - Product Description 65
Table 91: Cincinnati Children's Hospital Medical Center Pipeline Products & Ongoing Clinical Trials Overview 66
Table 92: Biomarker Panel - Lupus Nephritis - Product Status 66
Table 93: Biomarker Panel - Lupus Nephritis - Product Description 66
Table 94: Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 67
Table 95: Diagnostic Test - Auto-immune Disorder - Product Status 67
Table 96: Diagnostic Test - Auto-immune Disorder - Product Description 67
Table 97: Cofactor Genomics Inc Pipeline Products & Ongoing Clinical Trials Overview 68
Table 98: RNA Based Diagnostic Test - Multiple Sclerosis - Product Status 68
Table 99: RNA Based Diagnostic Test - Multiple Sclerosis - Product Description 68
Table 100: RNA Based Diagnostic Test - Parkinson's Disease - Product Status 69
Table 101: RNA Based Diagnostic Test - Parkinson's Disease - Product Description 69
Table 102: Crescendo Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 70
Table 103: Multi-Biomarker Test - Ankylosing Spondylitis - Product Status 70
Table 104: Multi-Biomarker Test - Ankylosing Spondylitis - Product Description 70
Table 105: Multi-Biomarker Test - Autoimmune Diseases - Product Status 71
Table 106: Multi-Biomarker Test - Autoimmune Diseases - Product Description 71
Table 107: Multi-Biomarker Test - Inflammatory Diseases - Product Status 71
Table 108: Multi-Biomarker Test - Inflammatory Diseases - Product Description 72
Table 109: Multi-Biomarker Test - Psoriatic Arthritis - Product Status 72
Table 110: Multi-Biomarker Test - Psoriatic Arthritis - Product Description 72
Table 111: Multi-Biomarker Test - Systemic Lupus Erythematosus - Product Status 73
Table 112: Multi-Biomarker Test - Systemic Lupus Erythematosus - Product Description 73
Table 113: Digna Biotech SL Pipeline Products & Ongoing Clinical Trials Overview 74
Table 114: Anti-CD-137 Antibodies Assay - Product Status 74
Table 115: Anti-CD-137 Antibodies Assay - Product Description 74
Table 116: Prognostic Test - Multiple Sclerosis - Product Status 75
Table 117: Prognostic Test - Multiple Sclerosis - Product Description 75
Table 118: Durin Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 76
Table 119: Diagnostic Test - Parkinson's Disease - Product Status 76
Table 120: Diagnostic Test - Parkinson's Disease - Product Description 76
Table 121: EMD Millipore Corp Pipeline Products & Ongoing Clinical Trials Overview 77
Table 122: Erenna IL-12 Immunoassay Kit - Product Status 77
Table 123: Erenna IL-12 Immunoassay Kit - Product Description 77
Table 124: Enterome Bioscience SA Pipeline Products & Ongoing Clinical Trials Overview 78
Table 125: Diagnostic Test - Multiple Sclerosis - Product Status 78
Table 126: Diagnostic Test - Multiple Sclerosis - Product Description 78
Table 127: Diagnostic Test - Type 2 Diabetes - Product Status 79
Table 128: Diagnostic Test - Type 2 Diabetes - Product Description 79
Table 129: Ezose Sciences Inc. Pipeline Products & Ongoing Clinical Trials Overview 80
Table 130: Biomarker Diagnostic Assay - Multiple Sclerosis - Product Status 80
Table 131: Biomarker Diagnostic Assay - Multiple Sclerosis - Product Description 80
Table 132: Flamentera AG Pipeline Products & Ongoing Clinical Trials Overview 81
Table 133: Diagnostic Test - Celiac Disease - Product Status 81
Table 134: Diagnostic Test - Celiac Disease - Product Description 81
Table 135: French National Institute of Health and Medical Research Pipeline Products & Ongoing Clinical Trials Overview 82
Table 136: Blood Based CRMP Biomarker Assay - Multiple Sclerosis - Product Status 82
Table 137: Blood Based CRMP Biomarker Assay - Multiple Sclerosis - Product Description 82
Table 138: Genalyte, Inc. Pipeline Products & Ongoing Clinical Trials Overview 83
Table 139: Maverick ANA 11 Assay Kit - Product Status 83
Table 140: Maverick ANA 11 Assay Kit - Product Description 83
Table 141: GeNeuro SA Pipeline Products & Ongoing Clinical Trials Overview 84
Table 142: GNbAC1 Test - Multiple Sclerosis - Product Status 84
Table 143: GNbAC1 Test - Multiple Sclerosis - Product Description 84
Table 144: Glycominds Ltd. Pipeline Products & Ongoing Clinical Trials Overview 85
Table 145: gMS DMT - Product Status 85
Table 146: gMS DMT - Product Description 85
Table 147: Grifols SA Pipeline Products & Ongoing Clinical Trials Overview 86
Table 148: Diagnostic Test - Autoimmunity - Product Status 86
Table 149: Diagnostic Test - Autoimmunity - Product Description 86
Table 150: Hannover Medical School Pipeline Products & Ongoing Clinical Trials Overview 87
Table 151: Diagnostic Test - Multiple Sclerosis - Product Status 87
Table 152: Diagnostic Test - Multiple Sclerosis - Product Description 87
Table 153: Helmholtz Centre for Infection Research Pipeline Products & Ongoing Clinical Trials Overview 88
Table 154: ELISA Based Assay - Rheumatic Fever - Product Status 88
Table 155: ELISA Based Assay - Rheumatic Fever - Product Description 88
Table 156: HOB Biotech Group Suzhou Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89
Table 157: HOB Biotech Diagnostic Assay - Auto-immunity - Product Status 89
Table 158: HOB Biotech Diagnostic Assay - Auto-immunity - Product Description 89
Table 159: Hospital for Special Surgery Pipeline Products & Ongoing Clinical Trials Overview 90
Table 160: Lupus Biomarkers - Product Status 90
Table 161: Lupus Biomarkers - Product Description 90
Table 162: Hummingbird Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 91
Table 163: Diagnostic Test - IBD - Product Status 91
Table 164: Diagnostic Test - IBD - Product Description 91
Table 165: Diagnostic Test - Multiple Sclerosis - Product Status 92
1.2 List of Figures
Figure 1: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Stage of Development 21
Figure 2: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Territory 22
Figure 3: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Regulatory Path 23
Figure 4: Auto-Immune Diseases Diagnostic Tests - Pipeline Products by Estimated Approval Date 24
Figure 5: Auto-Immune Diseases Diagnostic Tests - Ongoing Clinical Trials 25
