Hepatitis Test Kits - Medical Devices Pipeline Assessment, 2019

2019-12-01
Price :
Published : Dec-2019
No. of Pages : 279
Table of Contents
1.1 List of Tables 8
1.2 List of Figures 13
2 Introduction 14
2.1 Hepatitis Test Kits Overview 14
3 Products under Development 15
3.1 Hepatitis Test Kits - Pipeline Products by Stage of Development 15
3.2 Hepatitis Test Kits - Pipeline Products by Segment 16
3.3 Hepatitis Test Kits - Pipeline Products by Territory 17
3.4 Hepatitis Test Kits - Pipeline Products by Regulatory Path 18
3.5 Hepatitis Test Kits - Pipeline Products by Estimated Approval Date 19
4 Hepatitis Test Kits - Pipeline Products under Development by Companies 20
4.1 Hepatitis Test Kits Companies - Pipeline Products by Stage of Development 20
4.2 Hepatitis Test Kits - Pipeline Products by Stage of Development 22
5 Hepatitis Test Kits Companies and Product Overview 26
5.1 Abbott Diagnostics Company Overview 26
5.1.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 26
5.2 Alderon Biosciences Inc Company Overview 29
5.2.1 Alderon Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 29
5.3 AutoGenomics Inc Company Overview 30
5.3.1 AutoGenomics Inc Pipeline Products & Ongoing Clinical Trials Overview 30
5.4 AXO Science SAS Company Overview 32
5.4.1 AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 32
5.5 Beckman Coulter Inc Company Overview 33
5.5.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 33
5.6 Biokit SA Company Overview 34
5.6.1 Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 34
5.7 Biomagnetics Diagnostics Corp Company Overview 37
5.7.1 Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 37
5.8 Bio-Rad Laboratories Inc Company Overview 38
5.8.1 Bio-Rad Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 38
5.9 Boditech Med Inc Company Overview 39
5.9.1 Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 39
5.10 CeMines, Inc. (Inactive) Company Overview 42
5.10.1 CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 42
5.11 Cepheid Company Overview 43
5.11.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 43
5.12 China Medical Technologies Inc (Inactive) Company Overview 44
5.12.1 China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 44
5.13 Co-Diagnostics Inc Company Overview 45
5.13.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 45
5.14 Corgenix Medical Corp Company Overview 46
5.14.1 Corgenix Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 46
5.15 Da An Gene Co Ltd Company Overview 47
5.15.1 Da An Gene Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 47
5.16 Diagnostics for the Real World (Europe) Ltd Company Overview 50
5.16.1 Diagnostics for the Real World (Europe) Ltd Pipeline Products & Ongoing Clinical Trials Overview 50
5.17 DiaSorin SpA Company Overview 51
5.17.1 DiaSorin SpA Pipeline Products & Ongoing Clinical Trials Overview 51
5.18 D-Kimia, LLC. Company Overview 54
5.18.1 D-Kimia, LLC. Pipeline Products & Ongoing Clinical Trials Overview 54
5.19 DNAE Group Holdings Ltd Company Overview 55
5.19.1 DNAE Group Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 55
5.20 Ecoli sro Company Overview 56
5.20.1 Ecoli sro Pipeline Products & Ongoing Clinical Trials Overview 56
5.21 Ferrer inCode SL Company Overview 59
5.21.1 Ferrer inCode SL Pipeline Products & Ongoing Clinical Trials Overview 59
5.22 Fujirebio Diagnostics Inc Company Overview 60
5.22.1 Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 60
5.23 Genome Diagnostics Pvt. Ltd. Company Overview 68
5.23.1 Genome Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 68
5.24 HealthTell Inc Company Overview 69
5.24.1 HealthTell Inc Pipeline Products & Ongoing Clinical Trials Overview 69
5.25 Hepron Molecular Lab Inc Company Overview 71
5.25.1 Hepron Molecular Lab Inc Pipeline Products & Ongoing Clinical Trials Overview 71
5.26 Hologic Inc Company Overview 72
5.26.1 Hologic Inc Pipeline Products & Ongoing Clinical Trials Overview 72
5.27 Imperial College London Company Overview 73
5.27.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 73
5.28 LifeAssay Diagnostics (Pty) Ltd Company Overview 74
5.28.1 LifeAssay Diagnostics (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 74
5.29 MedMira Inc Company Overview 76
5.29.1 MedMira Inc Pipeline Products & Ongoing Clinical Trials Overview 76
5.30 Medosome Biotec LLC Company Overview 77
5.30.1 Medosome Biotec LLC Pipeline Products & Ongoing Clinical Trials Overview 77
5.31 Monogram Biosciences Inc Company Overview 78
5.31.1 Monogram Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 78
5.32 NanoDiagX Company Overview 79
5.32.1 NanoDiagX Pipeline Products & Ongoing Clinical Trials Overview 79
5.33 Ortho-Clinical Diagnostics Inc Company Overview 80
5.33.1 Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 80
5.34 Paramedical Srl Company Overview 85
5.34.1 Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 85
5.35 ProteinLogic Ltd Company Overview 91
5.35.1 ProteinLogic Ltd Pipeline Products & Ongoing Clinical Trials Overview 91
5.36 Qiagen NV Company Overview 92
5.36.1 Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 92
5.37 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Company Overview 94
5.37.1 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Pipeline Products & Ongoing Clinical Trials Overview 94
5.38 Roche Diagnostics International Ltd Company Overview 95
5.38.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 95
5.39 Sansure Biotech Inc Company Overview 103
5.39.1 Sansure Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 103
5.40 Seegene Inc Company Overview 106
5.40.1 Seegene Inc Pipeline Products & Ongoing Clinical Trials Overview 106
5.41 Shenzhen Mindray Bio-Medical Electronics Co Ltd Company Overview 109
5.41.1 Shenzhen Mindray Bio-Medical Electronics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 109
5.42 Siemens Healthcare Diagnostics Inc Company Overview 111
5.42.1 Siemens Healthcare Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 111
5.43 Siemens Healthineers AG Company Overview 114
5.43.1 Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 114
5.44 Stanford University Company Overview 118
5.44.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 118
5.45 Syamala Srinivasa Life Sciences Pvt. Ltd Company Overview 119
5.45.1 Syamala Srinivasa Life Sciences Pvt. Ltd Pipeline Products & Ongoing Clinical Trials Overview 119
5.46 Sysmex Corp Company Overview 121
5.46.1 Sysmex Corp Pipeline Products & Ongoing Clinical Trials Overview 121
5.47 TBG Diagnostics Ltd Company Overview 123
5.47.1 TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 123
5.48 University Medical Center Hamburg-Eppendorf Company Overview 125
5.48.1 University Medical Center Hamburg-Eppendorf Pipeline Products & Ongoing Clinical Trials Overview 125
5.49 University of British Columbia Company Overview 126
5.49.1 University of British Columbia Pipeline Products & Ongoing Clinical Trials Overview 126
5.50 University of Texas Medical Branch at Galveston Company Overview 127
5.50.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 127
5.51 University of Warwick Company Overview 128
5.51.1 University of Warwick Pipeline Products & Ongoing Clinical Trials Overview 128
5.52 Ustar Biotechnologies (Hangzhou) Ltd. Company Overview 129
5.52.1 Ustar Biotechnologies (Hangzhou) Ltd. Pipeline Products & Ongoing Clinical Trials Overview 129
5.53 Xiamen Zeesan Biotech Co.,Ltd Company Overview 130
5.53.1 Xiamen Zeesan Biotech Co.,Ltd Pipeline Products & Ongoing Clinical Trials Overview 130
6 Hepatitis Test Kits- Recent Developments 131
6.1 Nov 07, 2019: Trovagene announces third quarter 2019 results and highlights 131
6.2 Nov 06, 2019: LabCorp announces Departure of John Ratliff, names New LabCorp Diagnostics leadershin 133
6.3 Nov 06, 2019: GenMark Diagnostics reports third quarter 2019 results 133
6.4 Nov 06, 2019: OraSure announces 2019 third quarter financial results 134
6.5 Nov 06, 2019: Hologic announces financial results for fourth quarter of fiscal 2019 136
6.6 Nov 05, 2019: OPKO Health reports 2019 third quarter business highlights and financial results 138
6.7 Nov 04, 2019: Quotient reports second quarter fiscal 2020 financial results 139
6.8 Oct 31, 2019: Bio-Rad reports third-quarter 2019 financial results 141
6.9 Oct 31, 2019: Bio-Rad reports third-quarter 2019 financial results. 142
6.10 Oct 30, 2019: QIAGEN reports full results for third quarter and first nine months of 2019 143
7 Appendix 276
7.1 Methodology 276
7.2 About GlobalData 279
7.3 Contact Us 279
7.4 Disclaimer 279

List of Tables
Table 1: Hepatitis Test Kits - Pipeline Products by Stage of Development 17
Table 2: Hepatitis Test Kits - Pipeline Products by Segment 18
Table 3: Hepatitis Test Kits - Pipeline Products by Territory 19
Table 4: Hepatitis Test Kits - Pipeline Products by Regulatory Path 20
Table 5: Hepatitis Test Kits - Pipeline Products by Estimated Approval Date 21
Table 6: Hepatitis Test Kits Companies - Pipeline Products by Stage of Development 22
Table 7: Hepatitis Test Kits - Pipeline Products by Stage of Development 24
Table 8: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 28
Table 9: Alinity i Assay - HCV Ag - Product Status 28
Table 10: Alinity i Assay - HCV Ag - Product Description 28
Table 11: ARCHITECT c16000 System - HbSAg Assay - Product Status 30
Table 12: ARCHITECT c16000 System - HbSAg Assay - Product Description 30
Table 13: ARCHITECT c4000 System - HbSAg Assay - Product Status 30
Table 14: ARCHITECT c4000 System - HbSAg Assay - Product Description 30
Table 15: ARCHITECT c8000 System - HbSAg Next Qual Assay - Product Status 31
Table 16: ARCHITECT c8000 System - HbSAg Next Qual Assay - Product Description 31
Table 17: Alderon Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 32
Table 18: eSystem - Qualitative HCV RNA Assay - Product Status 32
Table 19: eSystem - Qualitative HCV RNA Assay - Product Description 32
Table 20: AutoGenomics Inc Pipeline Products & Ongoing Clinical Trials Overview 33
Table 21: INFINITI High Throughput System - Hepatitis C Virus (HCV) Genotyping Test - Product Status 33
Table 22: INFINITI High Throughput System - Hepatitis C Virus (HCV) Genotyping Test - Product Description 33
Table 23: INFINITI Plus - Hepatitis C Virus (HCV) Genotyping Test - Product Status 35
Table 24: INFINITI Plus - Hepatitis C Virus (HCV) Genotyping Test - Product Description 35
Table 25: AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 36
Table 26: Multiplexed Detection - Anti-HCV Antibodies - Product Status 36
Table 27: Multiplexed Detection - Anti-HCV Antibodies - Product Description 36
Table 28: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 37
Table 29: UniCel DxN - HCV Viral Load Test - Product Status 37
Table 30: UniCel DxN - HCV Viral Load Test - Product Description 37
Table 31: Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 38
Table 32: BIO-FLASH anti-HBe Assay - Product Status 38
Table 33: BIO-FLASH anti-HBe Assay - Product Description 38
Table 34: BIO-FLASH HAV Assay - Product Status 40
Table 35: BIO-FLASH HAV Assay - Product Description 40
Table 36: BIO-FLASH HBe Ag Assay - Product Status 40
Table 37: BIO-FLASH HBe Ag Assay - Product Description 41
Table 38: Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 42
Table 39: Diagnostic Test - Hepatitis B - Product Status 42
Table 40: Diagnostic Test - Hepatitis B - Product Description 42
Table 41: Bio-Rad Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 43
Table 42: BioPlex 2200 - Hepatitis Test - Product Status 43
Table 43: BioPlex 2200 - Hepatitis Test - Product Description 43
Table 44: Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 45
Table 45: AFIAS-6 - Anti-HBs Test - Product Status 45
Table 46: AFIAS-6 - Anti-HBs Test - Product Description 45
Table 47: AFIAS-6 - HBsAg Test - Product Status 46
Table 48: AFIAS-6 - HBsAg Test - Product Description 46
Table 49: ichroma Test - Anti-HBs - Product Status 46
Table 50: ichroma Test - Anti-HBs - Product Description 46
Table 51: ichroma Test - HBsAg - Product Status 47
Table 52: ichroma Test - HBsAg - Product Description 47
Table 53: ichroma Test - HCV - Product Status 47
Table 54: ichroma Test - HCV - Product Description 47
Table 55: CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49
Table 56: Diagnostic Test - Hepatitis C - Product Status 49
Table 57: Diagnostic Test - Hepatitis C - Product Description 49
Table 58: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 50
Table 59: Xpert HCV Quant Assay - Product Status 50
Table 60: Xpert HCV Quant Assay - Product Description 50
Table 61: China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 51
Table 62: Diagnostic Assay - HCVA - Product Status 51

List of Figures
Figure 1: Hepatitis Test Kits - Pipeline Products by Stage of Development 15
Figure 2: Hepatitis Test Kits - Pipeline Products by Segment 16
Figure 3: Hepatitis Test Kits - Pipeline Products by Territory 17
Figure 4: Hepatitis Test Kits - Pipeline Products by Regulatory Path 18
Figure 5: Hepatitis Test Kits - Pipeline Products by Estimated Approval Date 19
Filed in: Pharmaceutical, Pharmaceuticals and Healthcare
Publisher : GlobalData