Immunochemistry Analyzers - Medical Devices Pipeline Assessment, 2016

Table Of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 10
1.2 List of Figures 20
2 Introduction 21
2.1 Immunochemistry Analyzers Overview 21
3 Products under Development 23
3.1 Immunochemistry Analyzers - Pipeline Products by Stage of Development 23
3.2 Immunochemistry Analyzers - Pipeline Products by Segment 24
3.3 Immunochemistry Analyzers - Pipeline Products by Territory 25
3.4 Immunochemistry Analyzers - Pipeline Products by Regulatory Path 26
3.5 Immunochemistry Analyzers - Pipeline Products by Estimated Approval Date 27
3.6 Immunochemistry Analyzers - Ongoing Clinical Trials 28
4 Immunochemistry Analyzers - Pipeline Products under Development by Companies 29
4.1 Immunochemistry Analyzers Companies - Pipeline Products by Stage of Development 29
4.2 Immunochemistry Analyzers - Pipeline Products by Stage of Development 34
5 Immunochemistry Analyzers Companies and Product Overview 39
5.1 Acreo Swedish ICT AB Company Overview 39
5.2 AgPlus Diagnostics LTD Company Overview 40
5.3 Akers Biosciences, Inc. Company Overview 41
5.4 Akonni Biosystems, Inc. Company Overview 43
5.5 Amic AB (Inactive) Company Overview 44
5.6 ApoCell Inc Company Overview 45
5.7 Arcxis Biotechnologies Inc Company Overview 46
5.8 Assay Dynamics LLC (Inactive) Company Overview 47
5.9 Atonomics A/S Company Overview 48
5.10 Attophotonics Biosciences GmbH Company Overview 51
5.11 Beckman Coulter Inc Company Overview 52
5.12 Becton Dickinson and Company Company Overview 54
5.13 Binghamton University Company Overview 58
5.14 Bio-Alternative Medical Devices Ltd Company Overview 60
5.15 BioMedomics Inc Company Overview 62
5.16 bioMerieux S.A. Company Overview 64
5.17 BioNanovations Corporation Company Overview 66
5.18 Biopico Systems Inc. Company Overview 67
5.19 BioSIMS Company Overview 68
5.20 Boditech Med Inc. Company Overview 69
5.21 Boston University Company Overview 72
5.22 BreviTest Technologies LLC Company Overview 76
5.23 Canon U.S.A., Inc. Company Overview 77
5.24 CardioGenics Inc. Company Overview 78
5.25 Cepheid Company Overview 80
5.26 China Medical Technologies Inc (Inactive) Company Overview 83
5.27 ChipCare Corp Company Overview 85
5.28 Clearbridge BioLoc Pte Ltd Company Overview 88
5.29 Co-Diagnostics HBDC, Inc. Company Overview 89
5.30 Corgenix Medical Corp Company Overview 90
5.31 Courtagen Life Sciences Inc Company Overview 91
5.32 Curetis NV Company Overview 92
5.33 Denator AB Company Overview 94
5.34 DiaSorin S.p.A Company Overview 95
5.35 Dyamed Biotech Pte Ltd Company Overview 97
5.36 Dynex Technologies Company Overview 98
5.37 EKF Diagnostics Holdings Plc Company Overview 100
5.38 EMD Millipore Corp Company Overview 102
5.39 Enigma Diagnostics Limited Company Overview 104
5.40 Firalis SAS Company Overview 107
5.41 First Light Biosciences, Inc. Company Overview 109
5.42 GenePOC Inc. Company Overview 110
5.43 Genera Biosystems Ltd Company Overview 112
5.44 Genevo Biosystems Pte Ltd Company Overview 114
5.45 Genomas Inc Company Overview 115
5.46 Global Solutions for Infectious Diseases Company Overview 118
5.47 GNA Biosolutions GmbH Company Overview 120
5.48 Great Basin Corp Company Overview 122
5.49 Harvard University Company Overview 124
5.50 HeatFlow Technologies, Inc. Company Overview 126
5.51 Hologic Inc Company Overview 127
5.52 Indian Institute of Technology, Madras Company Overview 129
5.53 Indiana University Company Overview 131
5.54 Jana Care Inc. Company Overview 133
5.55 John Hopkins University Company Overview 135
5.56 LabNow Inc (Inactive) Company Overview 137
5.57 LaserGen, Inc. Company Overview 138
5.58 Lucerna Inc Company Overview 139
5.59 Magellan Diagnostics Inc Company Overview 140
5.60 Magna Diagnostics GmbH Company Overview 141
5.61 MAST GROUP Ltd. Company Overview 142
5.62 Maxygen-mobile DNA tests Company Overview 143
5.63 mBio Diagnostics, Inc. Company Overview 144
5.64 McKesson Corporation Company Overview 147
5.65 MedNostic Technologies, LLC Company Overview 149
5.66 Mesa Biotech Inc Company Overview 150
5.67 MML Ltd Company Overview 151
5.68 Mobidiag Ltd Company Overview 153
5.69 Molecular Warehouse Ltd Company Overview 154
5.70 Nalia Systems Ltd Company Overview 156
5.71 NanoLab, Inc. Company Overview 158
5.72 Nanomix Inc Company Overview 160
5.73 Nanosphere Inc Company Overview 161
5.74 Newcastle University Company Overview 162
5.75 NorthShore University Health System Company Overview 164
5.76 Ohmx Corp Company Overview 165
5.77 OncoGenesis Company Overview 167
5.78 OncoTherapy Science Inc Company Overview 168
5.79 Optofluidics, Inc. Company Overview 170
5.80 Ortho-Clinical Diagnostics Inc Company Overview 171
5.81 Ostendum R&D BV Company Overview 173
5.82 Pharmahungary Group Company Overview 174
5.83 Phoenix Biosystems Inc Company Overview 175
5.84 POC Medical Systems Inc. Company Overview 176
5.85 Polymedco CDP, LLC Company Overview 178
5.86 PositiveID Corp Company Overview 179
5.87 Protomex Life Sciences Company Overview 181
5.88 Qiagen NV Company Overview 182
5.89 Quanterix Corp Company Overview 184
5.90 Radisens Diagnostics Ltd Company Overview 186
5.91 Raman Diagnostics Limited Company Overview 188
5.92 Rapid Diagnostek, Inc. Company Overview 189
5.93 Roche Diagnostics International Ltd Company Overview 190
5.94 Royal College of Surgeons in Ireland Company Overview 192
5.95 Sebia SA Company Overview 193
5.96 SenGenix Inc Company Overview 194
5.97 Singulex Inc Company Overview 195
5.98 Stat-Diagnostica & Innovation, S.L. Company Overview 197
5.99 STRATEC Molecular GmbH Company Overview 199
5.100 Sysmex Corporation Company Overview 201
5.101 TearLab Corp Company Overview 203
5.102 Tecan Group Ltd Company Overview 205
5.103 Techcomp (Holdings) Limited Company Overview 206
5.104 The Palo Alto Research Center Company Overview 208
5.105 Thermal Gradient Inc Company Overview 209
5.106 Trinity Biotech Plc Company Overview 211
5.107 Tyncbest Biotechnology Company Overview 213
5.108 University of Alberta Company Overview 215
5.109 University of California Berkeley Company Overview 216
5.110 University of California Davis Company Overview 219
5.111 University of California San Diego Company Overview 222
5.112 University of Michigan Company Overview 223
5.113 University of Michigan Pediatric Device Consortium Company Overview 224
5.114 Vircell SL Company Overview 225
5.115 ViroCyt, Inc. Company Overview 227
5.116 Wellstat Diagnostics LLC Company Overview 228
5.117 Xanthostat Diagnostics Inc Company Overview 230
5.118 ZIN Technologies, Inc. Company Overview 231
6 Immunochemistry Analyzers- Recent Developments 232
6.1 Nov 17, 2016: ChipCare Raises USD2.1 Million in Series B Financing 232
6.2 Nov 14, 2016: HTG Molecular Diagnostics Reports Third Quarter 2016 Results 232
6.3 Nov 10, 2016: Response Biomedical Announces Third Quarter 2016 Financial Results 232
6.4 Nov 10, 2016: Siemens intends to further strengthen its healthcare business 233
6.5 Nov 09, 2016: John Wayne Cancer Institute Enters into Research Agreement with Clearbridge Biomedics 234
6.6 Nov 09, 2016: Trovagene Reports Third Quarter 2016 Financial Results and Accomplishments 234
6.7 Nov 08, 2016: Apricus Biosciences Provides Corporate Update and Third Quarter Financial Results 235
6.8 Nov 07, 2016: Roka Bioscience Reports Third Quarter 2016 Financial Results 237
6.9 Nov 07, 2016: Changes in the AYOXXA Management Team 238
6.10 Nov 04, 2016: Alere Reports Third Quarter 2016 Financial Results 238
6.11 Nov 03, 2016: GenMark Diagnostics Reports Q3 Financial Results 238
6.12 Nov 03, 2016: BD Announces Results For 2016 Fourth Fiscal Quarter And Full Year; Provides Fiscal 2017 Guidance 239
6.13 Nov 02, 2016: QIAGEN Reports Results for Third Quarter and First Nine Months of 2016 241
6.14 Nov 02, 2016: Lak Ananth to head new next47 startup unit 243
6.15 Nov 02, 2016: Hologic Announces Financial Results for Fourth Quarter of Fiscal 2016 244
6.16 Nov 02, 2016: NanoString Technologies Releases Operating Results for Third Quarter of 2016 245
6.17 Nov 01, 2016: Bio-Rad Reports Third-Quarter Currency-Neutral Revenue Growth of 9.1 Percent 246
6.18 Oct 31, 2016: Zenosense MIDS Cardiac Bench Reader Development 247
6.19 Oct 27, 2016: Novacyt Half Year 2016 Results 248
6.20 Oct 27, 2016: McKesson Reports Fiscal 2017 Second-Quarter Results and Revised Fiscal 2017 Outlook 250
6.21 Oct 27, 2016: Cempra Reports Third Quarter 2016 Financial Results and Provides Corporate Update 252
6.22 Oct 27, 2016: Thermo Fisher Scientific Reports Third Quarter 2016 Results 253
6.23 Oct 26, 2016: Quidel Reports Third Quarter 2016 Financial Results 254
6.24 Oct 26, 2016: Psychemedics Announces Record Revenues and Earnings 256
6.25 Oct 24, 2016: LabCorp is first US laboratory to offer molecular testing with new fully automated cobas 8800 system from Roche 257
6.26 Oct 24, 2016: McKesson Releases Fiscal 2016 Corporate Social Responsibility Report 257
6.27 Oct 21, 2016: Immunodiagnostic Systems Holdings: H1 Trading Update 258
6.28 Oct 20, 2016: ViroCyt Develops Rapid Detection System For Enterovirus 71 259
6.29 Oct 20, 2016: bioMerieux-Business Review for the nine months ended September 30, 2016 260
6.30 Oct 18, 2016: Johnson & Johnson Reports 2016 Third-Quarter Results 262
6.31 Oct 17, 2016: Thermo Fisher Scientific Enables Preemptive Pharmacogenomic Screening Research with New PharmacoScan Solution 264
6.32 Oct 13, 2016: General Biologicals to Raise up to USD10.2 Million in Public Offering of Shares 264
6.33 Oct 13, 2016: THERADIAG: Very strong revenue growth at end-September 2016: +31% 265
6.34 Oct 06, 2016: Eagle Biosciences Enters into Distribution Agreement with AroCell 265
6.35 Oct 04, 2016: Trinity Biotech Announces FDA 510(k) Submission withdrawal for Meritas Point of Care Analyzer 265
Africa 389
7 Appendix 390
7.1 Methodology 390
7.2 About GlobalData 393
7.3 Contact Us 393
7.4 Disclaimer 393

List Of Tables
1.1 List of Tables
Table 1: Immunochemistry Analyzers - Pipeline Products by Stage of Development 26
Table 2: Immunochemistry Analyzers - Pipeline Products by Segment 27
Table 3: Immunochemistry Analyzers - Pipeline Products by Territory 28
Table 4: Immunochemistry Analyzers - Pipeline Products by Regulatory Path 29
Table 5: Immunochemistry Analyzers - Pipeline Products by Estimated Approval Date 30
Table 6: Immunochemistry Analyzers - Ongoing Clinical Trials 31
Table 7: Immunochemistry Analyzers Companies - Pipeline Products by Stage of Development 32
Table 8: Immunochemistry Analyzers - Pipeline Products by Stage of Development 37
Table 9: Acreo Swedish ICT AB Pipeline Products & Ongoing Clinical Trials Overview 42
Table 10: Electronic Nanowire Bio - Sensor - Product Status 42
Table 11: Electronic Nanowire Bio - Sensor - Product Description 42
Table 12: AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 43
Table 13: AgPlus Diagnostic System - Product Status 43
Table 14: AgPlus Diagnostic System - Product Description 43
Table 15: Akers Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44
Table 16: minDNAnalyzer - Product Status 44
Table 17: minDNAnalyzer - Product Description 45
Table 18: Akonni Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 46
Table 19: Point-Of-Care Device - Tuberculosis - Product Status 46
Table 20: Point-Of-Care Device - Tuberculosis - Product Description 46
Table 21: Amic AB (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 47
Table 22: Optical Fluorescence Reader - Product Status 47
Table 23: Optical Fluorescence Reader - Product Description 47
Table 24: ApoCell Inc Pipeline Products & Ongoing Clinical Trials Overview 48
Table 25: ApoStream System - Product Status 48
Table 26: ApoStream System - Product Description 48
Table 27: Arcxis Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 49
Table 28: BioPhalanx Analyzer - Product Status 49
Table 29: BioPhalanx Analyzer - Product Description 49
Table 30: Assay Dynamics LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 50
Table 31: Automated Diagnostic Device - Product Status 50
Table 32: Automated Diagnostic Device - Product Description 50
Table 33: Atonomics A/S Pipeline Products & Ongoing Clinical Trials Overview 51
Table 34: Atolyzer Consumer Device - Product Status 51
Table 35: Atolyzer Consumer Device - Product Description 51
Table 36: Atolyzer Gene - Product Status 52
Table 37: Atolyzer Gene - Product Description 52
Table 38: Atolyzer PoC - Product Status 52
Table 39: Atolyzer PoC - Product Description 53
Table 40: Attophotonics Biosciences GmbH Pipeline Products & Ongoing Clinical Trials Overview 54
Table 41: Nanoparticle Microfluidic Color Device - Product Status 54
Table 42: Nanoparticle Microfluidic Color Device - Product Description 54
Table 43: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 55
Table 44: DxN VERIS MDx System - Product Status 55
Table 45: DxN VERIS MDx System - Product Description 56
Table 46: UniCel DxN - Product Status 56
Table 47: UniCel DxN - Product Description 56
Table 48: Becton Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview 57
Table 49: BD Viper LT System - HPV - Product Status 57
Table 50: BD Viper LT System - HPV - Product Description 58
Table 51: Becton Dickinson and Company - Ongoing Clinical Trials Overview 59
Table 52: BD Viper LT System - HPV - Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System with Cervical Specimens 60
Table 53: Binghamton University Pipeline Products & Ongoing Clinical Trials Overview 61
Table 54: Ultra-Sensitive Portable Capillary Sensor - Product Status 61
Table 55: Ultra-Sensitive Portable Capillary Sensor - Product Description 62
Table 56: Bio-Alternative Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 63
Table 57: Magnetic Immunoassay Detection System - Product Status 63
Table 58: Magnetic Immunoassay Detection System - Product Description 64
Table 59: BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 65
Table 60: Next Generation Ultra-sensitive Nanotube Platform - Product Status 65
Table 61: Next Generation Ultra-sensitive Nanotube Platform - Product Description 66
Table 62: TR-LFIA Diagnostic Platform - Product Status 66
Table 63: TR-LFIA Diagnostic Platform - Product Description 66
Table 64: bioMerieux S.A. Pipeline Products & Ongoing Clinical Trials Overview 67
Table 65: Magnotech System - Product Status 67
Table 66: Magnotech System - Product Description 68
Table 67: BioNanovations Corporation Pipeline Products & Ongoing Clinical Trials Overview 69
Table 68: TestQuick - Product Status 69
Table 69: TestQuick - Product Description 69
Table 70: Biopico Systems Inc. Pipeline Products & Ongoing Clinical Trials Overview 70
Table 71: MONITOR System - Product Status 70
Table 72: MONITOR System - Product Description 70
Table 73: BioSIMS Pipeline Products & Ongoing Clinical Trials Overview 71
Table 74: DigiPLEX Analyzer - Product Status 71
Table 75: DigiPLEX Analyzer - Product Description 71
Table 76: Boditech Med Inc. Pipeline Products & Ongoing Clinical Trials Overview 72
Table 77: AFIAS6 - Product Status 72
Table 78: AFIAS6 - Product Description 73
Table 79: I-Chroma Ifob With I-Chroma Reader - Product Status 73
Table 80: I-Chroma Ifob With I-Chroma Reader - Product Description 74
Table 81: Boston University Pipeline Products & Ongoing Clinical Trials Overview 75
Table 82: Lab-On-A-Chip - Thyroid Cancer - Product Status 75
Table 83: Lab-On-A-Chip - Thyroid Cancer - Product Description 76
Table 84: Molecular Diagnostic Device - Sexually Transmitted Infections - Product Status 76
Table 85: Molecular Diagnostic Device - Sexually Transmitted Infections - Product Description 77
Table 86: Real-Time Multiplexed Diagnostic System - Hemorrhagic Fever - Product Status 77
Table 87: Real-Time Multiplexed Diagnostic System - Hemorrhagic Fever - Product Description 78
Table 88: BreviTest Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 79
Table 89: BreviTest Portable Analyzer - Product Status 79
Table 90: BreviTest Portable Analyzer - Product Description 79
Table 91: Canon U.S.A., Inc. Pipeline Products & Ongoing Clinical Trials Overview 80
Table 92: Automated Diagnostic System - Infectious Disease - Product Status 80
Table 93: Automated Diagnostic System - Infectious Disease - Product Description 80
Table 94: CardioGenics Inc. Pipeline Products & Ongoing Clinical Trials Overview 81
Table 95: QL Care Analyzer - Product Status 81
Table 96: QL Care Analyzer - Product Description 82
Table 97: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 83
Table 98: GeneXpert Omni - Product Status 83
Table 99: GeneXpert Omni - Product Description 84
Table 100: GeneXpert Omni CLIA-Waived Point-of-Care System - Product Status 84
Table 101: GeneXpert Omni CLIA-Waived Point-of-Care System - Product Description 85
Table 102: China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 86
Table 103: AUTOLIA-12/48 - Product Status 86
Table 104: AUTOLIA-12/48 - Product Description 87
Table 105: SPR Analyzer - Product Status 87
Table 106: SPR Analyzer - Product Description 87
Table 107: ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 88
Table 108: Portable Cell Analyzer - Food Borne Diseases - Product Status 88
Table 109: Portable Cell Analyzer - Food Borne Diseases - Product Description 88
Table 110: Portable Cell Analyzer - HIV - Product Status 89
Table 111: Portable Cell Analyzer - HIV - Product Description 89
Table 112: Portable Cell Analyzer - Malaria - Product Status 89
Table 113: Portable Cell Analyzer - Malaria - Product Description 90
Table 114: Portable Cell Analyzer - Tuberculosis - Product Status 90
Table 115: Portable Cell Analyzer - Tuberculosis - Product Description 90
Table 116: Clearbridge BioLoc Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 91
Table 117: AssayQuest - Product Status 91
Table 118: AssayQuest - Product Description 91
Table 119: Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 92
Table 120: LightPCR - Product Status 92
Table 121: LightPCR - Product Description 92
Table 122: Corgenix Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 93
Table 123: ELISA Microplate Reader - Product Status 93
Table 124: ELISA Microplate Reader - Product Description 93

List Of Figures
1.2 List of Figures
Figure 1: Immunochemistry Analyzers - Pipeline Products by Stage of Development 26
Figure 2: Immunochemistry Analyzers - Pipeline Products by Segment 27
Figure 3: Immunochemistry Analyzers - Pipeline Products by Territory 28
Figure 4: Immunochemistry Analyzers - Pipeline Products by Regulatory Path 29
Figure 5: Immunochemistry Analyzers - Pipeline Products by Estimated Approval Date 30
Figure 6: Immunochemistry Analyzers - Ongoing Clinical Trials 31

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