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

Transcription

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

2 Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 2016 BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen years. BioPortfolio offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, BioPortfolio is well positioned to coordinate our customers' orders sourced from over 50 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or reportstore@bioportfolio.com 2

3 Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 2016 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 3

4 - 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 Additional Details Publisher : Global Data Reference : GDME0208EPD Number of Pages : 53 Report Format : PDF Publisher Information : 4

5 Table Of Contents for Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, Table of Contents1 Table of Contents 21.1 List of Tables 41.2 List of Figures 52 Introduction 62.1 Herpes Simplex Virus (HSV) Diagnostic Tests Overview 63 Products under Development 73.1 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Stage of Development 73.2 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Territory 83.3 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Regulatory Path 93.4 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Estimated Approval Date 104 Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products under Development by Companies Herpes Simplex Virus (HSV) Diagnostic Tests Companies - Pipeline Products by Stage of Development Herpes Simplex Virus (HSV) Diagnostic Tests - Pipeline Products by Stage of Development 125 Herpes Simplex Virus (HSV) Diagnostic Tests Companies and Product Overview Becton, Dickinson and Company Company Overview Becton, Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview Biokit, S.A. Company Overview Biokit, S.A. Pipeline Products & Ongoing Clinical Trials Overview Cepheid Company Overview Cepheid Pipeline Products & Ongoing Clinical Trials Overview Da An Gene Co., Ltd. Company Overview Da An Gene Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview DiaSorin S.p.A Company Overview DiaSorin S.p.A Pipeline Products & Ongoing Clinical Trials Overview Genera Biosystems Limited Company Overview Genera Biosystems Limited Pipeline Products & Ongoing Clinical Trials Overview Hologic, Inc. Company Overview Hologic, Inc. Pipeline Products & Ongoing Clinical Trials Overview OPKO Health, Inc. Company Overview OPKO Health, Inc. Pipeline Products & Ongoing Clinical Trials Overview Qiagen N.V. Company Overview Qiagen N.V. Pipeline Products & Ongoing Clinical Trials Overview Roche Diagnostics International Ltd. Company Overview Roche Diagnostics International Ltd. Pipeline Products & Ongoing Clinical Trials Overview Theranos, Inc. Company Overview Theranos, Inc. Pipeline Products & Ongoing Clinical Trials Overview University of Texas Medical Branch at Galveston Company Overview University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview VEGA Ltd Company Overview VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 396 Herpes Simplex Virus (HSV) Diagnostic Tests - Recent Developments Jun 13, 2016: OPKO Health Announces Move to NASDAQ Stock Market May 16, 2016: Luminex to Highlight ARIES System at the 2016 Clinical Virology Symposium May 11, 2016: Theranos Announces Expansion of Board of Directors and New Organizational Structure May 09, 2016: OPKO Health Reports First Quarter Financial and Operating Results Mar 21, 2016: Luminex Receives CE-IVD Mark for ARIES HSV 1&2 Assay Feb 22, 2016: Luminex Receives Medical Device License for ARIES HSV 1&2 Assay in Canada Nov 03, 2015: SeraCare Life Sciences Announces Early Access Programs for ctdna and RNA Fusion Reference Materials Oct 07, 2015: Luminex Corporation Receives FDA Clearance for ARIES HSV 1&2 Assay Sep 03, 2015: Focus Diagnostics Receives FDA Clearance to Add Genital Swab Claim to Moderate Complexity Simplexa HSV 1 & 2 Direct Molecular Test Jul 29, 2015: SeraCare Life Sciences Unveils Rebranding Initiative to Support Company s Expanding Capabilities for Precision Diagnostics Jul 20, 2015: Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene HSV Jul 20, 2015: Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene HSV Jul 14, 2015: Luminex Submits FDA 510(k) Submission for ARIES HSV 1&2 Assay Jul 02, 2015: FDA Clears Theranos s Herpes Simplex 1 Virus IgG Test 487 Appendix Methodology About GlobalData Contact Us Disclaimer 53 5

6 List Of Tables in Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 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 6

7 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 Herpes Simplex Virus 1 and 2 - Product Status 28 Table 37: QIAensemble 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 7

8 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 8

9 List Of Figures, Charts and Diagrams in Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 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 9

10 How to Buy... Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 2016 Option 1 - Online Go to our website and pay online with any major debit or credit card: Option 2 - Request a Proforma Invoice Fill in the details below, and either Scan this page and it to us at reportstore@bioportfolio.com or Fax it to us at +44 (0) We will send you a Proforma Invoice and deliver your report on settlement. Your Name: Job Title: Your Your Contact Phone: Company Name: Address: Post/Zip Code: Country: P.O. Number: Any Other Instructions: Pricing Options: (please tick one) $2500 Single User Price $5000 Site License Price $7500 Enterprise License Price Payment Options: (please tick one) Online Credit Card (we will you the invoice with a payment link) Direct Wire Transfer (we will you the invoice with our bank details) Authorising Signature: Option 3 - Phone Us on +44 (0) We will be delighted to give you our personal attention. 10