Sections
| Title | Starting Page | Number of Pages |
|---|
| 1 Table of Contents | 2 | 14 |
| 1.1 List of Tables | 7 | 8 |
| 1.2 List of Figures | 15 | 1 |
| 2 Introduction | 16 | 1 |
| 2.1 Hepatitis Viruses Diagnostic Tests Overview | 16 | 1 |
| 3 Products under Development | 17 | 4 |
| 3.1 Hepatitis Viruses Diagnostic Tests - Pipeline Products by Stage of Development | 17 | 1 |
| 3.2 Hepatitis Viruses Diagnostic Tests - Pipeline Products by Territory | 18 | 1 |
| 3.3 Hepatitis Viruses Diagnostic Tests - Pipeline Products by Regulatory Path | 19 | 1 |
| 3.4 Hepatitis Viruses Diagnostic Tests - Pipeline Products by Estimated Approval Date | 20 | 1 |
| 4 Hepatitis Viruses Diagnostic Tests - Pipeline Products under Development by Companies | 21 | 7 |
| 4.1 Hepatitis Viruses Diagnostic Tests Companies - Pipeline Products by Stage of Development | 21 | 3 |
| 4.2 Hepatitis Viruses Diagnostic Tests - Pipeline Products by Stage of Development | 24 | 4 |
| 5 Hepatitis Viruses Diagnostic Tests Companies and Product Overview | 28 | 129 |
| 5.1 Abbott Diagnostics Diagnostic Tests Company Overview | 28 | 1 |
| 5.1.1 Abbott Diagnostics Pipeline Products &Ongoing Clinical Trials Overview | 28 | 4 |
| 5.2 Access Bio, Inc. Company Overview | 32 | 1 |
| 5.2.1 Access Bio, Inc. Pipeline Products &Ongoing Clinical Trials Overview | 32 | 1 |
| 5.3 Alderon Biosciences, Inc. Company Overview | 33 | 1 |
| 5.3.1 Alderon Biosciences, Inc. Pipeline Products &Ongoing Clinical Trials Overview | 33 | 1 |
| 5.4 Alere Inc Company Overview | 34 | 1 |
| 5.4.1 Alere Inc Pipeline Products &Ongoing Clinical Trials Overview | 34 | 2 |
| 5.5 AutoGenomics Inc Company Overview | 36 | 1 |
| 5.5.1 AutoGenomics Inc Pipeline Products &Ongoing Clinical Trials Overview | 36 | 2 |
| 5.6 AXO Science SAS Company Overview | 38 | 1 |
| 5.6.1 AXO Science SAS Pipeline Products &Ongoing Clinical Trials Overview | 38 | 2 |
| 5.7 BCR Corp Company Overview | 40 | 1 |
| 5.7.1 BCR Corp Pipeline Products &Ongoing Clinical Trials Overview | 40 | 2 |
| 5.8 Beckman Coulter Inc Company Overview | 42 | 1 |
| 5.8.1 Beckman Coulter Inc Pipeline Products &Ongoing Clinical Trials Overview | 42 | 4 |
| 5.9 Biokit, S.A. Company Overview | 46 | 1 |
| 5.9.1 Biokit, S.A. Pipeline Products &Ongoing Clinical Trials Overview | 46 | 3 |
| 5.10 Biomagnetics Diagnostics Corporation (Inactive) Company Overview | 49 | 1 |
| 5.10.1 Biomagnetics Diagnostics Corporation (Inactive) Pipeline Products &Ongoing Clinical Trials Overview | 49 | 1 |
| 5.11 Bio-Rad Laboratories Inc Company Overview | 50 | 1 |
| 5.11.1 Bio-Rad Laboratories Inc Pipeline Products &Ongoing Clinical Trials Overview | 50 | 2 |
| 5.12 CeMines, Inc. Company Overview | 52 | 1 |
| 5.12.1 CeMines, Inc. Pipeline Products &Ongoing Clinical Trials Overview | 52 | 1 |
| 5.13 Cepheid Company Overview | 53 | 1 |
| 5.13.1 Cepheid Pipeline Products &Ongoing Clinical Trials Overview | 53 | 2 |
| 5.14 China Medical Technologies Inc (Inactive) Company Overview | 55 | 1 |
| 5.14.1 China Medical Technologies Inc (Inactive) Pipeline Products &Ongoing Clinical Trials Overview | 55 | 2 |
| 5.15 Co-Diagnostics HBDC, Inc. Company Overview | 57 | 1 |
| 5.15.1 Co-Diagnostics HBDC, Inc. Pipeline Products &Ongoing Clinical Trials Overview | 57 | 1 |
| 5.16 Corgenix Medical Corp Company Overview | 58 | 1 |
| 5.16.1 Corgenix Medical Corp Pipeline Products &Ongoing Clinical Trials Overview | 58 | 1 |
| 5.17 Da An Gene Co Ltd Company Overview | 59 | 1 |
| 5.17.1 Da An Gene Co Ltd Pipeline Products &Ongoing Clinical Trials Overview | 59 | 4 |
| 5.18 Diagnostics for the Real World (Europe) Ltd. Company Overview | 63 | 1 |
| 5.18.1 Diagnostics for the Real World (Europe) Ltd. Pipeline Products &Ongoing Clinical Trials Overview | 63 | 1 |
| 5.19 DiaSorin S.p.A Company Overview | 64 | 1 |
| 5.19.1 DiaSorin S.p.A Pipeline Products &Ongoing Clinical Trials Overview | 64 | 4 |
| 5.20 D-Kimia, LLC. Company Overview | 68 | 1 |
| 5.20.1 D-Kimia, LLC. Pipeline Products &Ongoing Clinical Trials Overview | 68 | 1 |
| 5.21 Ecoli s.r.o. Company Overview | 69 | 1 |
| 5.21.1 Ecoli s.r.o. Pipeline Products &Ongoing Clinical Trials Overview | 69 | 14 |
| 5.22 Enzo Biochem Inc Company Overview | 83 | 1 |
| 5.22.1 Enzo Biochem Inc Pipeline Products &Ongoing Clinical Trials Overview | 83 | 2 |
| 5.23 Fast-track diagnostics S.a.r.l. Company Overview | 85 | 1 |
| 5.23.1 Fast-track diagnostics S.a.r.l. Pipeline Products &Ongoing Clinical Trials Overview | 85 | 5 |
| 5.24 Ferrer inCode SL Company Overview | 90 | 1 |
| 5.24.1 Ferrer inCode SL Pipeline Products &Ongoing Clinical Trials Overview | 90 | 1 |
| 5.25 French National Institute of Health and Medical Research Company Overview | 91 | 1 |
| 5.25.1 French National Institute of Health and Medical Research Pipeline Products &Ongoing Clinical Trials Overview | 91 | 1 |
| 5.26 genedrive plc Company Overview | 92 | 1 |
| 5.26.1 genedrive plc Pipeline Products &Ongoing Clinical Trials Overview | 92 | 2 |
| 5.27 Genera Biosystems Ltd Company Overview | 94 | 1 |
| 5.27.1 Genera Biosystems Ltd Pipeline Products &Ongoing Clinical Trials Overview | 94 | 2 |
| 5.28 GenMark Diagnostics Inc Company Overview | 96 | 1 |
| 5.28.1 GenMark Diagnostics Inc Pipeline Products &Ongoing Clinical Trials Overview | 96 | 2 |
| 5.29 Goodgene Inc Company Overview | 98 | 1 |
| 5.29.1 Goodgene Inc Pipeline Products &Ongoing Clinical Trials Overview | 98 | 2 |
| 5.30 Hologic Inc Company Overview | 100 | 1 |
| 5.30.1 Hologic Inc Pipeline Products &Ongoing Clinical Trials Overview | 100 | 3 |
| 5.31 Imperial College London Company Overview | 103 | 1 |
| 5.31.1 Imperial College London Pipeline Products &Ongoing Clinical Trials Overview | 103 | 1 |
| 5.32 MedMira Inc. Company Overview | 104 | 1 |
| 5.32.1 MedMira Inc. Pipeline Products &Ongoing Clinical Trials Overview | 104 | 2 |
| 5.33 Mindray Medical International Ltd Company Overview | 106 | 1 |
| 5.33.1 Mindray Medical International Ltd Pipeline Products &Ongoing Clinical Trials Overview | 106 | 10 |
| 5.34 MND Diagnostic LTD Company Overview | 116 | 1 |
| 5.34.1 MND Diagnostic LTD Pipeline Products &Ongoing Clinical Trials Overview | 116 | 1 |
| 5.35 Molbio Diagnostics Pvt. Ltd. Company Overview | 117 | 1 |
| 5.35.1 Molbio Diagnostics Pvt. Ltd. Pipeline Products &Ongoing Clinical Trials Overview | 117 | 1 |
| 5.36 NanoDiagX Company Overview | 118 | 1 |
| 5.36.1 NanoDiagX Pipeline Products &Ongoing Clinical Trials Overview | 118 | 1 |
| 5.37 OPKO Health Inc Company Overview | 119 | 1 |
| 5.37.1 OPKO Health Inc Pipeline Products &Ongoing Clinical Trials Overview | 119 | 2 |
| 5.38 Orangelife Company Overview | 121 | 1 |
| 5.38.1 Orangelife Pipeline Products &Ongoing Clinical Trials Overview | 121 | 1 |
| 5.39 Pathogenica Inc Company Overview | 122 | 1 |
| 5.39.1 Pathogenica Inc Pipeline Products &Ongoing Clinical Trials Overview | 122 | 1 |
| 5.40 ProteinLogic Ltd Company Overview | 123 | 1 |
| 5.40.1 ProteinLogic Ltd Pipeline Products &Ongoing Clinical Trials Overview | 123 | 1 |
| 5.41 Qiagen NV Company Overview | 124 | 1 |
| 5.41.1 Qiagen NV Pipeline Products &Ongoing Clinical Trials Overview | 124 | 2 |
| 5.42 Quotient Limited Company Overview | 126 | 1 |
| 5.42.1 Quotient Limited Pipeline Products &Ongoing Clinical Trials Overview | 126 | 2 |
| 5.43 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Company Overview | 128 | 1 |
| 5.43.1 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Pipeline Products &Ongoing Clinical Trials Overview | 128 | 1 |
| 5.44 Roche Diagnostics International Ltd Company Overview | 129 | 1 |
| 5.44.1 Roche Diagnostics International Ltd Pipeline Products &Ongoing Clinical Trials Overview | 129 | 9 |
| 5.45 Sansure Biotech Inc Company Overview | 138 | 1 |
| 5.45.1 Sansure Biotech Inc Pipeline Products &Ongoing Clinical Trials Overview | 138 | 4 |
| 5.46 Siemens Healthcare GmbH Company Overview | 142 | 1 |
| 5.46.1 Siemens Healthcare GmbH Pipeline Products &Ongoing Clinical Trials Overview | 142 | 6 |
| 5.47 Stanford University Company Overview | 148 | 1 |
| 5.47.1 Stanford University Pipeline Products &Ongoing Clinical Trials Overview | 148 | 1 |
| 5.48 Syamala Srinivasa Life Sciences Pvt. Ltd Company Overview | 149 | 1 |
| 5.48.1 Syamala Srinivasa Life Sciences Pvt. Ltd Pipeline Products &Ongoing Clinical Trials Overview | 149 | 2 |
| 5.49 The University of British Columbia Company Overview | 151 | 1 |
| 5.49.1 The University of British Columbia Pipeline Products &Ongoing Clinical Trials Overview | 151 | 1 |
| 5.50 University Medical Center Hamburg-Eppendorf Company Overview | 152 | 1 |
| 5.50.1 University Medical Center Hamburg-Eppendorf Pipeline Products &Ongoing Clinical Trials Overview | 152 | 1 |
| 5.51 University of Texas Medical Branch at Galveston Company Overview | 153 | 1 |
| 5.51.1 University of Texas Medical Branch at Galveston Pipeline Products &Ongoing Clinical Trials Overview | 153 | 1 |
| 5.52 University of Warwick Company Overview | 154 | 1 |
| 5.52.1 University of Warwick Pipeline Products &Ongoing Clinical Trials Overview | 154 | 1 |
| 5.53 Ustar Biotechnologies (Hangzhou) Ltd. Company Overview | 155 | 1 |
| 5.53.1 Ustar Biotechnologies (Hangzhou) Ltd. Pipeline Products &Ongoing Clinical Trials Overview | 155 | 1 |
| 5.54 Xiamen Zeesan Biotech Co.,Ltd Company Overview | 156 | 1 |
| 5.54.1 Xiamen Zeesan Biotech Co.,Ltd Pipeline Products &Ongoing Clinical Trials Overview | 156 | 1 |
| 6 Hepatitis Viruses Diagnostic Tests- Recent Developments | 157 | 98 |
| 6.1 Nov 15, 2016: OraSure Technologies Appoints Stephen S. Tang, Ph.D. as Chairman of the Board of Directors | 157 | 1 |
| 6.2 Nov 10, 2016: Hologic Obtains Canadian Approval for Aptima Hepatitis C Quant Assay | 157 | 1 |
| 6.3 Nov 10, 2016: Hologic Obtains Canadian Approval for Aptima Hepatitis B Quant Assay | 158 | 1 |
| 6.4 Nov 09, 2016: Trovagene Reports Third Quarter 2016 Financial Results and Accomplishments | 159 | 1 |
| 6.5 Nov 07, 2016: OPKO Health Reports Third Quarter Financial and Operating Results | 160 | 1 |
| 6.6 Nov 04, 2016: Alere Reports Third Quarter 2016 Financial Results | 161 | 1 |
| 6.7 Nov 03, 2016: GenMark Diagnostics Reports Q3 Financial Results | 161 | 1 |
| 6.8 Nov 02, 2016: Quotient Announces CFO Transition | 162 | 1 |
| 6.9 Nov 02, 2016: QIAGEN Reports Results for Third Quarter and First Nine Months of 2016 | 162 | 3 |
| 6.10 Nov 02, 2016: Hologic Announces Financial Results for Fourth Quarter of Fiscal 2016 | 165 | 2 |
| 6.11 Nov 02, 2016: OraSure Announces 2016 Third Quarter Financial Results | 167 | 1 |
| 6.12 Nov 01, 2016: Bio-Rad Reports Third-Quarter Currency-Neutral Revenue Growth of 9.1 Percent | 168 | 1 |
| 6.13 Oct 31, 2016: Quotient Second Quarter Fiscal 2017 Financial Results | 169 | 2 |
| 6.14 Oct 31, 2016: Quotient Reports Continued Progress on the Commercial Scale-up of MosaiQ and Second Quarter Fiscal 2017 Financial Results | 171 | 2 |
| 6.15 Oct 26, 2016: Laboratory Corporation of America Holdings Announces 2016 Third Quarter Results and Updates 2016 Guidance | 173 | 2 |
| 6.16 Oct 20, 2016: bioMerieux-Business Review for the nine months ended September 30, 2016 | 175 | 2 |
| 6.17 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results | 177 | 3 |
| 6.18 Oct 14, 2016: Quotient Raises USD84 million in First Tranche of Private Placement of 12% Notes Due 2023 | 180 | 1 |
| 6.19 Oct 13, 2016: General Biologicals to Raise up to USD10.2 Million in Public Offering of Shares | 180 | 1 |
| 6.20 Oct 13, 2016: Enzo Biochem Reports Strong 2016 Operating Results | 181 | 2 |
| 6.21 Oct 11, 2016: Genedrive Announces Preliminary Results for the year ended 30 June 2016 | 183 | 5 |
| 6.22 Sep 21, 2016: Genedrive Announces Appointment of Chief Financial Officer | 188 | 1 |
| 6.23 Sep 20, 2016: LabCorp Names Veteran Biopharma Executive John Ratliff CEO of Covance Drug Development | 189 | 1 |
| 6.24 Sep 13, 2016: OPKO Health Appoints Jane Pine Wood as Chief Legal and Compliance Officer of BioReference Laboratories | 189 | 1 |
| 6.25 Sep 06, 2016: Alere Reports Second Quarter 2016 Financial Results | 190 | 1 |
| 6.26 Sep 02, 2016: Danaher Acquires Cepheid | 190 | 1 |
| 6.27 Aug 31, 2016: bioMerieux - First-Half 2016 Results | 191 | 3 |
| 6.28 Aug 30, 2016: DiaSorin Enters into Agreement with Beckman Coulter | 194 | 1 |
| 6.29 Aug 17, 2016: Alere Reports First Quarter 2016 Financial Results | 195 | 1 |
| 6.30 Aug 08, 2016: Quotient Reports Further Progress on the Commercial Scale-up of MosaiQ and First Quarter Fiscal 2017 Financial Results | 195 | 2 |
| 6.31 Aug 08, 2016: OPKO Health Reports Improved Financial and Operating Results | 197 | 1 |
| 6.32 Aug 08, 2016: Alere Files Form 10-K, Reports Fourth Quarter and Full Year 2015 Financial Results | 198 | 2 |
| 6.33 Aug 04, 2016: Trovagene Reports Second Quarter 2016 Financial Results and Accomplishments | 200 | 1 |
| 6.34 Aug 04, 2016: Diasorin Group Revenues And EBITDA Reached Record highs In the Second Quarter 2016 | 201 | 3 |
| 6.35 Aug 03, 2016: Bio-Rad Reports Second-Quarter 2016 Financial Results | 204 | 1 |
| 6.36 Aug 03, 2016: OraSure Announces 2016 Second Quarter Financial Results | 205 | 1 |
| 6.37 Jul 28, 2016: Vela Diagnostics HCV Genotyping Next-Generation Sequencing Assay Receives HSA Approval for in-vitro diagnostic use | 206 | 1 |
| 6.38 Jul 28, 2016: Quotient Raises USD17.7 Million in Public Offering of Shares | 207 | 1 |
| 6.39 Jul 28, 2016: GenMark Diagnostics Reports Q2 Financial Results | 207 | 1 |
| 6.40 Jul 28, 2016: QIAGEN Reports Results for Second Quarter of 2016; Increased Commitment to Return $300 Million of Capital to Shareholders by End-2017 | 208 | 3 |
| 6.41 Jul 28, 2016: Cepheid Reports Second Quarter 2016 Results | 211 | 1 |
| 6.42 Jul 28, 2016: Eiger BioPharmaceuticals Announces Partnership with the Hepatitis B Foundation | 211 | 1 |
| 6.43 Jul 27, 2016: Laboratory Corporation of America Holdings Announces 2016 Second Quarter Results and Raises 2016 Guidance | 212 | 2 |
| 6.44 Jul 27, 2016: Hologic Announces Financial Results for Third Quarter of Fiscal 2016 | 214 | 2 |
| 6.45 Jul 25, 2016: Epistem Holdings Announces Re change of name, TIDM and website address | 216 | 1 |
| 6.46 Jul 20, 2016: Abbott Reports Second-Quarter 2016 Results | 216 | 3 |
| 6.47 Jul 18, 2016: bioMerieux Second-Quarter 2016 Business Review | 219 | 3 |
| 6.48 Jul 11, 2016: Quotient Reports Preliminary Fiscal First Quarter 2017 Revenues | 222 | 1 |
| 6.49 Jul 11, 2016: Epistem Holdings Announces Result of General Meeting and Change of Name | 222 | 1 |
| 6.50 Jul 07, 2016: Enzo Biochem s Life Sciences Unit Reaches $21 Million Patent Infringement Settlement in Delaware With Illumina | 223 | 1 |
| 6.51 Jul 04, 2016: Exiqon Nomination of candidates for the supervisory board | 223 | 1 |
| 6.52 Jun 29, 2016: MedMira Reports FY2016 Third Quarter Results | 223 | 1 |
| 6.53 Jun 24, 2016: Genome British Columbia Investing in Companies and Jobs Through e@UBC | 223 | 1 |
| 6.54 Jun 15, 2016: Siemens Healthcare Becomes Siemens Healthineers | 224 | 1 |
| 6.55 Jun 14, 2016: Vela Diagnostics Announces Launch of CE-IVD HCV Genotyping Next-Generation Sequencing Assay | 224 | 1 |
| 6.56 Jun 13, 2016: OPKO Health Announces Move to NASDAQ Stock Market | 225 | 1 |
| 6.57 Jun 08, 2016: Enzo Biochem Reports Fiscal Third Quarter Results | 225 | 2 |
| 6.58 Jun 07, 2016: Epistem Holdings to Raise USD9.37 Million in Private Placement of Shares | 227 | 1 |
| 6.59 May 23, 2016: Quotient Reports Continued Progress on the Development of MosaiQ and Fourth Quarter and Fiscal Year 2016 Financial Results | 227 | 4 |
| 6.60 May 17, 2016: Advanced Biological Labs Enters into Licensing Agreement with Inserm Transfert | 231 | 1 |
| 6.61 May 10, 2016: Trovagene Announces First Quarter 2016 Financial Results | 231 | 1 |
| 6.62 May 09, 2016: OPKO Health Reports First Quarter Financial and Operating Results | 232 | 2 |
| 6.63 May 03, 2016: Vela Diagnostics Announces the Launch of TGA approved Sentosa SQ HCV Genotyping Assay and the Availability of NGS-based HIV Genotyping Assay for Early Access Customers | 234 | 1 |
| 6.64 Apr 28, 2016: Cepheid Reports First Quarter 2016 Results | 234 | 1 |
| 6.65 Apr 27, 2016: QIAGEN Reports Results for First Quarter of 2016 | 235 | 3 |
| 6.66 Apr 20, 2016: Abbott Reports First-Quarter 2016 Results | 238 | 2 |
| 6.67 Apr 14, 2016: Quest Launches New Hepatitis C Virus Test Capabilities for Recently FDA-approved Antiviral Therapies | 240 | 1 |
| 6.68 Apr 13, 2016: Quotient Announces Positive MosaiQ Serological Disease Screening Results | 241 | 1 |
| 6.69 Mar 24, 2016: MedMira Reports Second Quarter Results for FY2016 | 242 | 1 |
| 6.70 Mar 23, 2016: Renowned scientist will lead rare mission to address the epidemic of heart failure | 243 | 1 |
| 6.71 Mar 21, 2016: FDA approves expanded use of Roche hepatitis C virus RNA test as aid in diagnosis | 243 | 1 |
| 6.72 Mar 03, 2016: Fast-track diagnostics: Trial Kits | 244 | 1 |
| 6.73 Feb 17, 2016: Specificity and sensitivity of Fast-track diagnostics hepatitis E assay proven in comparison study | 244 | 1 |
| 6.74 Feb 10, 2016: Cepheid Announces Appointment of President and Chief Operating Officer and Welcomes Executive Vice President of Engineering and Operations | 245 | 1 |
| 6.75 Feb 03, 2016: Fast-track diagnostics Reports 22% Sales Increase in 2015 versus 2014 | 246 | 1 |
| 6.76 Feb 02, 2016: QIAGEN Reports Results for Fourth Quarter and Full-Year 2015 | 246 | 4 |
| 6.77 Feb 02, 2016: Cepheid Reports Fourth Quarter And Full Year 2015 Results | 250 | 1 |
| 6.78 Jan 10, 2016: QIAGEN Announces Preliminary Results for Full-Year 2015 and Provides 2016 Outlook | 251 | 1 |
| 6.79 Dec 22, 2015: New Roche HBV Test expands cobas 4800 System menu | 251 | 1 |
| 6.80 Dec 14, 2015: MedMira Reports Fiscal First Quarter 2016 Financial Results | 252 | 1 |
| 6.81 Dec 10, 2015: Hologic Expands its European Virology Portfolio with CE-IVD Certified Assay for Hepatitis B Virus Viral Load | 253 | 1 |
| 6.82 Nov 30, 2015: Vela Diagnostics s Sentosa SQ HCV Genotyping Assays shown 100% clinical accuracy and sensitivity | 253 | 1 |
| 6.83 Nov 24, 2015: MedMira Reports 2015 Fourth Quarter and Year End Financial Results | 254 | 1 |
| 7 Appendix | 255 | 4 |
| 7.1 Methodology | 255 | 3 |
| 7.2 About GlobalData | 258 | 1 |
| 7.3 Contact Us | 258 | 1 |
| 7.4 Disclaimer | 258 | 1 |
