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Herpes Simplex Virus (HSV) Diagnostic Tests - Medical Devices Pipeline Assessment, 2016 Report / Search Code: WGR530813
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Publish Date: 1 July, 2016
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Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Medical Devices Pipeline As s es s ment, 2016 Summary GlobalData's Medical Devices s ector report, “Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Medical Devices Pipeline As s es s ment, 2016" provides an overview of Herpes Simplex Virus (HSV) Diagnos tic Tes ts currently in pipeline s tage. The report provides comprehens ive information on the pipeline products with comparative analys is of the products at various s tages of development. The report reviews major players involved in the pipeline product development. It als o provides information about clinical trials in progres s , which includes trial phas e, trial s tatus , trial s tart and end dates , and, the number of trials for the key Herpes Simplex Virus (HSV) Diagnos tic Tes ts pipeline products . This report is prepared us ing data s ourced from in-hous e databas es , s econdary and primary res earch by GlobalData's team of indus try experts . *Note: Certain s ections in the report may be removed or altered bas ed on the availability and relevance of data in relation to the equipment type. Scope - Extens ive coverage of the Herpes Simplex Virus (HSV) Diagnos tic Tes ts under development - The report reviews details of major pipeline products which includes , product des cription, licens ing and collaboration details and other developmental activities - The report reviews the major players involved in the development of Herpes Simplex Virus (HSV) Diagnos tic Tes ts and lis t all their pipeline projects - The coverage of pipeline products bas ed on various s tages of development ranging from Early Development to Approved / Is s ued s tage - The report provides key clinical trial data of ongoing trials s pecific to pipeline products - Recent developments in the s egment / indus try Reas ons to buy The report enables you to - Formulate s ignificant competitor information, analys is , and ins ights to improve R& D s trategies - Identify emerging players with potentially s trong product portfolio and create effective counter-s trategies to gain competitive advantage - Identify and unders tand important and divers e types of Herpes Simplex Virus (HSV) Diagnos tic Tes ts under development - Develop market-entry and market expans ion s trategies - Plan mergers and acquis itions effectively by identifying major players with the mos t promis ing pipeline - In-depth analys is of the product’s current s tage of development, territory and es timated launch date
Contents:
1 Table of Contents 1 Table of Contents 2 1.1 Lis t of Tables 4 1.2 Lis t of Figures 5 2 Introduction 6 2.1 Herpes Simplex Virus (HSV) 3 Products under Development 7 3.1 Herpes Simplex Virus (HSV) Development 7 3.2 Herpes Simplex Virus (HSV) 8 3.3 Herpes Simplex Virus (HSV)
Diagnos tic Tes ts Overview 6 Diagnos tic Tes ts - Pipeline Products by Stage of Diagnos tic Tes ts - Pipeline Products by Territory Diagnos tic Tes ts - Pipeline Products by
Regulatory Path 9 3.4 Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Es timated Approval Date 10 4 Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products under Development by Companies 11 4.1 Herpes Simplex Virus (HSV) Diagnos tic Tes ts Companies - Pipeline Products by Stage of Development 11 4.2 Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Stage of Development 12 5 Herpes Simplex Virus (HSV) Diagnos tic Tes ts Companies and Product Overview 13 5.1 Becton, Dickins on and Company Company Overview 13 5.1.1 Becton, Dickins on 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 Bios ys tems Limited Company Overview 22 5.6.1 Genera Bios ys tems 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 Diagnos tics International Ltd. Company Overview 30 5.10.1 Roche Diagnos tics 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 Univers ity of Texas Medical Branch at Galves ton Company Overview 38 5.12.1 Univers ity of Texas Medical Branch at Galves ton 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) Diagnos tic Tes ts - 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 Sys tem at the 2016 Clinical Virology Sympos ium 40 6.3 May 11, 2016: Theranos Announces Expans ion of Board of Directors and New Organizational Structure 41 6.4 May 09, 2016: OPKO Health Reports Firs t Quarter Financial and Operating Res ults 42 6.5 Mar 21, 2016: Luminex Receives CE-IVD Mark for ARIES HSV 1& 2 As s ay 44 6.6 Feb 22, 2016: Luminex Receives Medical Device Licens e for ARIES HSV 1& 2 As s ay in Canada 44 6.7 Nov 03, 2015: SeraCare Life Sciences Announces Early Acces s Programs for ctDNA and RNA Fus ion Reference Materials 44 6.8 Oct 07, 2015: Luminex Corporation Receives FDA Clearance for ARIES HSV 1& 2 As s ay 45 6.9 Sep 03, 2015: Focus Diagnos tics Receives FDA Clearance to Add Genital Swab Claim to Moderate Complexity Simplexa HSV 1 & 2 Direct Molecular Tes t 46 6.10 Jul 29, 2015: SeraCare Life Sciences Unveils Rebranding Initiative to Support Company’s Expanding Capabilities for Precis ion Diagnos tics 47 6.11 Jul 20, 2015: Meridian Bios cience Receives FDA Clearance for New Molecular Amplification Tes t: illumigene HSV 1 47 6.12 Jul 20, 2015: Meridian Bios cience Receives FDA Clearance for New Molecular Amplification Tes t: illumigene HSV 2 48 6.13 Jul 14, 2015: Luminex Submits FDA 510(k) Submis s ion for ARIES HSV 1& 2 As s ay 48 6.14 Jul 02, 2015: FDA Clears Theranos ’s Herpes Simplex 1 Virus IgG Tes t 48 7 Appendix 50 7.1 Methodology 50 7.2 About GlobalData 52 7.3 Contact Us 53 7.4 Dis claimer 53 1.1 Lis t of Tables Table 1: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Stage of Development 7 Table 2: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Territory 8 Table 3: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by
Regulatory Path 9 Table 4: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Es timated Approval Date 10 Table 5: Herpes Simplex Virus (HSV) Diagnos tic Tes ts Companies - Pipeline Products by Stage of Development 11 Table 6: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Stage of Development 12 Table 7: Becton, Dickins on and Company Pipeline Products & Ongoing Clinical Trials Overview 13 Table 8: BD Viper LT HSV 1/2 As s ay - Product Status 13 Table 9: BD Viper LT HSV 1/2 As s ay - Product Des cription 14 Table 10: Biokit, S.A. Pipeline Products & Ongoing Clinical Trials Overview 15 Table 11: BIO-FLASH HSV 1+2 IgM As s ay - Product Status 15 Table 12: BIO-FLASH HSV 1+2 IgM As s ay - Product Des cription 16 Table 13: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 17 Table 14: Xpert HSV 1 And 2 Tes t - Product Status 17 Table 15: Xpert HSV 1 And 2 Tes t - Product Des cription 18 Table 16: Xpert HSV CSF As s ay - Product Status 18 Table 17: Xpert HSV CSF As s ay - Product Des cription 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 Des cription 20 Table 21: DiaSorin S.p.A Pipeline Products & Ongoing Clinical Trials Overview 21 Table 22: Diagnos tic As s ay - HSV M + cntr - Product Status 21 Table 23: Diagnos tic As s ay - HSV M + cntr - Product Des cription 21 Table 24: Genera Bios ys tems Limited Pipeline Products & Ongoing Clinical Trials Overview 22 Table 25: Diagnos tic Tes t- Herpes Simplex Virus (HSV) 1 / HSV 2 - Product Status 22 Table 26: Diagnos tic Tes t- Herpes Simplex Virus (HSV) 1 / HSV 2 - Product Des cription 23 Table 27: Hologic, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24 Table 28: Panther Sys tem - HSV-1 As s ay - Product Status 24 Table 29: Panther Sys tem - HSV-1 As s ay - Product Des cription 25 Table 30: Panther Sys tem - HSV-2 As s ay - Product Status 25 Table 31: Panther Sys tem - HSV-2 As s ay - Product Des cription 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 Des cription 27 Table 35: Qiagen N.V. Pipeline Products & Ongoing Clinical Trials Overview 28 Table 36: QIAens emble 400 - Herpes Simplex Virus 1 and 2 - Product Status 28 Table 37: QIAens emble 400 - Herpes Simplex Virus 1 and 2 - Product Des cription 29 Table 38: Roche Diagnos tics International Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30 Table 39: Cobas 6000 Analyzer Series With c501/e601 HSV-2 Tes t - Product Status 30 Table 40: Cobas 6000 Analyzer Series With c501/e601 HSV-2 Tes t - Product Des cription 31 Table 41: Cobas 6000 Analyzer Series With c501/e601 Module - HSV-1 Tes t - Product Status 31 Table 42: Cobas 6000 Analyzer Series With c501/e601 Module - HSV-1 Tes t - Product Des cription 31 Table 43: Cobas 8000 Analyzer Series With c 701 Module - HSV Type I And II As s ay Product Status 32 Table 44: Cobas 8000 Analyzer Series With c 701 Module - HSV Type I And II As s ay Product Des cription 32 Table 45: Cobas 8000 Analyzer Series With c 702 Module - HSV Type I and II As s ay Product Status 33 Table 46: Cobas 8000 Analyzer Series With c 702 Module - HSV Type I and II As s ay Product Des cription 33 Table 47: Theranos , Inc. Pipeline Products & Ongoing Clinical Trials Overview 34 Table 48: HSV-1 IgG Tes t - Capillary Plas ma - Product Status 34 Table 49: HSV-1 IgG Tes t - Capillary Plas ma - Product Des cription 35 Table 50: HSV-1 IgG Tes t - Capillary Whole Blood - Product Status 35 Table 51: HSV-1 IgG Tes t - Capillary Whole Blood - Product Des cription 35 Table 52: HSV-1 IgG Tes t - Venous Plas ma - Product Status 36 Table 53: HSV-1 IgG Tes t - Venous Plas ma - Product Des cription 36 Table 54: HSV-1 IgG Tes t - Venous Serum - Product Status 37 Table 55: HSV-1 IgG Tes t - Venous Serum - Product Des cription 37 Table 56: Univers ity of Texas Medical Branch at Galves ton Pipeline Products & Ongoing Clinical Trials Overview 38 Table 57: Diagnos tic As s ay - HSV - Product Status 38 Table 58: Diagnos tic As s ay - HSV - Product Des cription 38 Table 59: VEGA Ltd Pipeline Products & Ongoing Clinical Trials Overview 39 Table 60: Enzyme Immunoas s ay - HSV2 - Product Status 39 Table 61: Enzyme Immunoas s ay - HSV2 - Product Des cription 39 Table 62: Glos s ary 51 1.2 Lis t of Figures Figure 1: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Stage
of Development 7 Figure 2: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Territory 8 Figure 3: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Regulatory Path 9 Figure 4: Herpes Simplex Virus (HSV) Diagnos tic Tes ts - Pipeline Products by Es timated Approval Date 10
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