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Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 2016

Published: Jul 1, 2016 | Pages: 53 | Publisher: GlobalData | Industry: Medical Devices | Report Format: Electronic (PDF)

Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 2016" provides an overview of Herpes Simplex Virus (HSV) Diagnostic Tests currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Herpes Simplex Virus (HSV) Diagnostic Tests pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Herpes Simplex Virus (HSV) Diagnostic Tests under development
- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
- The report reviews the major players involved in the development of Herpes Simplex Virus (HSV) Diagnostic Tests and list all their pipeline projects
- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
- The report provides key clinical trial data of ongoing trials specific to pipeline products
- Recent developments in the segment / industry

Reasons To Buy

The report enables you to - 
- Formulate significant competitor information, analysis, and insights to improve R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of Herpes Simplex Virus (HSV) Diagnostic Tests under development
- Develop market-entry and market expansion strategies
- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
- In-depth analysis of the product's current stage of development, territory and estimated launch date
 Table of Contents
1 Table of Contents 2 1.1 List of Tables 4 1.2 List of Figures 5 2 Introduction 6 2.1 Herpes Simplex Virus (HSV) Diagnostic Tests Overview 6 3 Products under Development 7 3.1 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Stage of Development 7 3.2 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Territory 8 3.3 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Regulatory Path 9 3.4 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Estimated Approval Date 10 4 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products under Development by Companies 11 4.1 Herpes Simplex Virus (HSV) Diagnostic Tests Companies - Pipeline Products by Stage of Development 11 4.2 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Stage of Development 12 5 Herpes Simplex Virus (HSV) Diagnostic Tests Companies and Product Overview 13 5.1 Becton, Dickinson and Company Company Overview 13 5.1.1 Becton, Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview 13 5.2 Biokit, S.A. Company Overview 15 5.2.1 Biokit, S.A. Pipeline Products & Ongoing Clinical Trials Overview 15 5.3 Cepheid Company Overview 17 5.3.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 17 5.4 Da An Gene Co., Ltd. Company Overview 19 5.4.1 Da An Gene Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 19 5.5 DiaSorin S.p.A Company Overview 21 5.5.1 DiaSorin S.p.A Pipeline Products & Ongoing Clinical Trials Overview 21 5.6 Genera Biosystems Limited Company Overview 22 5.6.1 Genera Biosystems Limited Pipeline Products & Ongoing Clinical Trials Overview 22 5.7 Hologic, Inc. Company Overview 24 5.7.1 Hologic, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24 5.8 OPKO Health, Inc. Company Overview 26 5.8.1 OPKO Health, Inc. Pipeline Products & Ongoing Clinical Trials Overview 26 5.9 Qiagen N.V. Company Overview 28 5.9.1 Qiagen N.V. Pipeline Products & Ongoing Clinical Trials Overview 28 5.10 Roche Diagnostics International Ltd. Company Overview 30 5.10.1 Roche Diagnostics International Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30 5.11 Theranos, Inc. Company Overview 34 5.11.1 Theranos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34 5.12 University of Texas Medical Branch at Galveston Company Overview 38 5.12.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 38 5.13 VEGA Ltd Company Overview 39 5.13.1 VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 39 6 Herpes Simplex Virus (HSV) Diagnostic Tests - Recent Developments 40 6.1 Jun 13, 2016: OPKO Health Announces Move to NASDAQ Stock Market 40 6.2 May 16, 2016: Luminex to Highlight ARIES System at the 2016 Clinical Virology Symposium 40 6.3 May 11, 2016: Theranos Announces Expansion of Board of Directors and New Organizational Structure 41 6.4 May 09, 2016: OPKO Health Reports First Quarter Financial and Operating Results 42 6.5 Mar 21, 2016: Luminex Receives CE-IVD Mark for ARIES HSV 1&2 Assay 44 6.6 Feb 22, 2016: Luminex Receives Medical Device License for ARIES HSV 1&2 Assay in Canada 44 6.7 Nov 03, 2015: SeraCare Life Sciences Announces Early Access Programs for ctDNA and RNA Fusion Reference Materials 44 6.8 Oct 07, 2015: Luminex Corporation Receives FDA Clearance for ARIES HSV 1&2 Assay 45 6.9 Sep 03, 2015: Focus Diagnostics Receives FDA Clearance to Add Genital Swab Claim to Moderate Complexity Simplexa HSV 1 & 2 Direct Molecular Test 46 6.10 Jul 29, 2015: SeraCare Life Sciences Unveils Rebranding Initiative to Support Company's Expanding Capabilities for Precision Diagnostics 47 6.11 Jul 20, 2015: Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene HSV 1 47 6.12 Jul 20, 2015: Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene HSV 2 48 6.13 Jul 14, 2015: Luminex Submits FDA 510(k) Submission for ARIES HSV 1&2 Assay 48 6.14 Jul 02, 2015: FDA Clears Theranos's Herpes Simplex 1 Virus IgG Test 48 7 Appendix 50 7.1 Methodology 50 7.2 About GlobalData 52 7.3 Contact Us 53 7.4 Disclaimer 53
List of Tables
Table 1: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Stage of Development 7 Table 2: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Territory 8 Table 3: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Regulatory Path 9 Table 4: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Estimated Approval Date 10 Table 5: Herpes Simplex Virus (HSV) Diagnostic Tests Companies - Pipeline Products by Stage of Development 11 Table 6: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Stage of Development 12 Table 7: Becton, Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview 13 Table 8: BD Viper LT HSV 1/2 Assay - Product Status 13 Table 9: BD Viper LT HSV 1/2 Assay - Product Description 14 Table 10: Biokit, S.A. Pipeline Products & Ongoing Clinical Trials Overview 15 Table 11: BIO-FLASH HSV 1+2 IgM Assay - Product Status 15 Table 12: BIO-FLASH HSV 1+2 IgM Assay - Product Description 16 Table 13: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 17 Table 14: Xpert HSV 1 And 2 Test - Product Status 17 Table 15: Xpert HSV 1 And 2 Test - Product Description 18 Table 16: Xpert HSV CSF Assay - Product Status 18 Table 17: Xpert HSV CSF Assay - Product Description 18 Table 18: Da An Gene Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 19 Table 19: Real Time PCR Kit - HSV General Type - Product Status 19 Table 20: Real Time PCR Kit - HSV General Type - Product Description 20 Table 21: DiaSorin S.p.A Pipeline Products & Ongoing Clinical Trials Overview 21 Table 22: Diagnostic Assay - HSV M + cntr - Product Status 21 Table 23: Diagnostic Assay - HSV M + cntr - Product Description 21 Table 24: Genera Biosystems Limited Pipeline Products & Ongoing Clinical Trials Overview 22 Table 25: Diagnostic Test- Herpes Simplex Virus (HSV) 1 / HSV 2 - Product Status 22 Table 26: Diagnostic Test- Herpes Simplex Virus (HSV) 1 / HSV 2 - Product Description 23 Table 27: Hologic, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24 Table 28: Panther System - HSV-1 Assay - Product Status 24 Table 29: Panther System - HSV-1 Assay - Product Description 25 Table 30: Panther System - HSV-2 Assay - Product Status 25 Table 31: Panther System - HSV-2 Assay - Product Description 25 Table 32: OPKO Health, Inc. Pipeline Products & Ongoing Clinical Trials Overview 26 Table 33: mChip - Herpes - Product Status 26 Table 34: mChip - Herpes - Product Description 27 Table 35: Qiagen N.V. Pipeline Products & Ongoing Clinical Trials Overview 28 Table 36: QIAensemble 400 - Herpes Simplex Virus 1 and 2 - Product Status 28 Table 37: QIAensemble 400 - Herpes Simplex Virus 1 and 2 - Product Description 29 Table 38: Roche Diagnostics International Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30 Table 39: Cobas 6000 Analyzer Series With c501/e601 HSV-2 Test - Product Status 30 Table 40: Cobas 6000 Analyzer Series With c501/e601 HSV-2 Test - Product Description 31 Table 41: Cobas 6000 Analyzer Series With c501/e601 Module - HSV-1 Test - Product Status 31 Table 42: Cobas 6000 Analyzer Series With c501/e601 Module - HSV-1 Test - Product Description 31 Table 43: Cobas 8000 Analyzer Series With c 701 Module - HSV Type I And II Assay - Product Status 32 Table 44: Cobas 8000 Analyzer Series With c 701 Module - HSV Type I And II Assay - Product Description 32 Table 45: Cobas 8000 Analyzer Series With c 702 Module - HSV Type I and II Assay - Product Status 33 Table 46: Cobas 8000 Analyzer Series With c 702 Module - HSV Type I and II Assay - Product Description 33 Table 47: Theranos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34 Table 48: HSV-1 IgG Test - Capillary Plasma - Product Status 34 Table 49: HSV-1 IgG Test - Capillary Plasma - Product Description 35 Table 50: HSV-1 IgG Test - Capillary Whole Blood - Product Status 35 Table 51: HSV-1 IgG Test - Capillary Whole Blood - Product Description 35 Table 52: HSV-1 IgG Test - Venous Plasma - Product Status 36 Table 53: HSV-1 IgG Test - Venous Plasma - Product Description 36 Table 54: HSV-1 IgG Test - Venous Serum - Product Status 37 Table 55: HSV-1 IgG Test - Venous Serum - Product Description 37 Table 56: University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 38 Table 57: Diagnostic Assay - HSV - Product Status 38 Table 58: Diagnostic Assay - HSV - Product Description 38 Table 59: VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 39 Table 60: Enzyme Immunoassay - HSV2 - Product Status 39 Table 61: Enzyme Immunoassay - HSV2 - Product Description 39 Table 62: Glossary 51


List of Figures
Figure 1: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Stage of Development 7 Figure 2: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Territory 8 Figure 3: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Regulatory Path 9 Figure 4: Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Estimated Approval Date 10

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