Cervical Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2016

 Published On: Aug, 2016 |    No of Pages: 93 |  Published By: GlobalData | Format: PDF
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Summary

"Cervical Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2016" provides an overview of Cervical Cancer 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 Cervical Cancer 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 Cervical Cancer 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 Cervical Cancer 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 Cervical Cancer 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

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 8
2 Introduction 9
2.1 Cervical Cancer Diagnostic Tests Overview 9
3 Products under Development 10
3.1 Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 10
3.2 Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 11
3.3 Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 12
3.4 Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 13
3.5 Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 14
4 Cervical Cancer Diagnostic Tests - Pipeline Products under Development by Companies 15
4.1 Cervical Cancer Diagnostic Tests Companies - Pipeline Products by Stage of Development 15
4.2 Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 17
5 Cervical Cancer Diagnostic Tests Companies and Product Overview 19
5.1 Abbott Diagnostics Company Overview 19
5.1.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 19
5.2 Aindra Systems Pvt. Ltd. Company Overview 21
5.2.1 Aindra Systems Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 21
5.3 Alere Inc. Company Overview 23
5.3.1 Alere Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
5.4 Arbor Vita Corporation Company Overview 25
5.4.1 Arbor Vita Corporation Pipeline Products & Ongoing Clinical Trials Overview 25
5.5 Becton, Dickinson and Company Company Overview 27
5.5.1 Becton, Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview 27
5.6 BioAffinity Technologies, Inc. Company Overview 29
5.6.1 BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29
5.7 BioMark Diagnostics Inc. Company Overview 30
5.7.1 BioMark Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 30
5.8 BioMark Technologies Inc. Company Overview 31
5.8.1 BioMark Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
5.9 Cancer Research Technology Limited Company Overview 32
5.9.1 Cancer Research Technology Limited Pipeline Products & Ongoing Clinical Trials Overview 32
5.10 Cepheid Company Overview 33
5.10.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 33
5.11 China Sky One Medical, Inc. Company Overview 35
5.11.1 China Sky One Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35
5.12 Cytosystems Ltd Company Overview 37
5.12.1 Cytosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 37
5.13 Enzo Life Sciences, Inc. Company Overview 39
5.13.1 Enzo Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39
5.14 Genisphere Inc. Company Overview 41
5.14.1 Genisphere Inc. Pipeline Products & Ongoing Clinical Trials Overview 41
5.15 Genomic Vision Company Overview 42
5.15.1 Genomic Vision Pipeline Products & Ongoing Clinical Trials Overview 42
5.16 GenomicTree, Inc. Company Overview 46
5.16.1 GenomicTree, Inc. Pipeline Products & Ongoing Clinical Trials Overview 46
5.17 Golden Valley Development, Inc. Company Overview 48
5.17.1 Golden Valley Development, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48
5.18 GRANT Life Sciences, Inc. Company Overview 49
5.18.1 GRANT Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 49
5.19 Louisville Bioscience, Inc. Company Overview 50
5.19.1 Louisville Bioscience, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50
5.20 MDNA Life Sciences, Inc. Company Overview 51
5.20.1 MDNA Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51
5.21 MDxHealth SA Company Overview 53
5.21.1 MDxHealth SA Pipeline Products & Ongoing Clinical Trials Overview 53
5.22 Milagen, Inc. Company Overview 55
5.22.1 Milagen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 55
5.23 NeoDiagnostix, Inc. Company Overview 56
5.23.1 NeoDiagnostix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 56
5.24 Newcastle University Company Overview 57
5.24.1 Newcastle University Pipeline Products & Ongoing Clinical Trials Overview 57
5.25 Oncgnostics GmbH Company Overview 59
5.25.1 Oncgnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 59
5.26 ONCOVEDA Cancer Research Center Company Overview 61
5.26.1 ONCOVEDA Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 61
5.27 Orion Genomics LLC Company Overview 62
5.27.1 Orion Genomics LLC Pipeline Products & Ongoing Clinical Trials Overview 62
5.28 Precision Biologics, Inc. Company Overview 63
5.28.1 Precision Biologics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63
5.29 Preciva Incorporated Company Overview 64
5.29.1 Preciva Incorporated Pipeline Products & Ongoing Clinical Trials Overview 64
5.30 Roche Diagnostics International Ltd. Company Overview 65
5.30.1 Roche Diagnostics International Ltd. Pipeline Products & Ongoing Clinical Trials Overview 65
5.31 University of Manchester Company Overview 66
5.31.1 University of Manchester Pipeline Products & Ongoing Clinical Trials Overview 66
5.32 US Biomarkers, Inc. Company Overview 67
5.32.1 US Biomarkers, Inc. Pipeline Products & Ongoing Clinical Trials Overview 67
5.33 Vanderbilt University Company Overview 68
5.33.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 68
5.34 Vigilant Biosciences, Inc. Company Overview 69
5.34.1 Vigilant Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 69
5.35 XEPTAGEN SpA Company Overview 70
5.35.1 XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 70
6 Cervical Cancer Diagnostic Tests - Recent Developments 71
6.1 Aug 04, 2016: BD Announces Results For 2016 Third Fiscal Quarter 71
6.2 Jul 28, 2016: BD Names R. Andrew Eckert To Board Of Directors 72
6.3 Jul 28, 2016: Cepheid Reports Second Quarter 2016 Results 73
6.4 Jul 26, 2016: Genomic Vision Announces Results For The First Half Of 2016 73
6.5 Jul 21, 2016: Quest Diagnostics Reports Second Quarter 2016 Financial Results 76
6.6 Jul 20, 2016: Genomic Vision is accelerating its clinical trial in cervical cancer with an additional study in the Czech Republic 77
6.7 Jul 11, 2016: Vigilant Biosciences Raises USD5 Million in Series B2 Financing Round 77
6.8 Jul 07, 2016: bioAffinity Technologies Appoints New Senior VP for Research & Development of Therapeutics 78
6.9 Jun 27, 2016: Cancer Genetics Names Healthcare Technology Industry Veteran John Jay Roberts as COO and Executive Vice President of Finance 78
6.10 Jun 16, 2016: The Clinical Trial Undertaken by Genomic Vision and Reims University Hospital to Validate a New Test for the Early Detection and Treatment of Cervical Cancer Was Chosen for an Oral Presentation at the Eurogin Congress in Salzburg 79
6.11 Jun 15, 2016: Qiagen Enters into Licensing Agreement with MDxHealth 79
6.12 Jun 15, 2016: Quest Diagnostics and Safeway Team to Offer Convenient Diagnostic Testing to Customers in More States 79
6.13 May 31, 2016: Quest Diagnostics and HCA's HealthONE System Partner to Deliver High-Value and Innovative Laboratory Services at Six Denver-Area HealthONE Hospitals 80
6.14 May 25, 2016: MEDITE Cancer Diagnostics Raises USD0.15 Million in Venture Financing 81
6.15 May 25, 2016: Stage I Diagnostics Raises USD0.1 Million in Venture Financing 81
6.16 May 25, 2016: Vigilant Biosciences Names Scientific Advisory Board and Expands Leadership Team, Appoints Dr. Michael Donovan as Chief Clinical Officer 81
6.17 May 23, 2016: Quest Diagnostics Raises USD500 Million in Public Offering of 3.45% Senior Notes due 2026 82
6.18 May 17, 2016: Cancer Prevention and Research Institute of Texas Marks Progress at the Halfway Point of its Funding 82
6.19 May 10, 2016: Cancer Genetics Announces 39% Revenue Increase and Provides Recent Company Highlights 84
6.20 Mar 08, 2016: Roche receives China Food and Drug Administration approval for the CINtec PLUS Cytology test to help prevent women from developing cervical cancer 85
6.21 Jan 20, 2016: Safe Diagnostics for Women Tested HPV-Positive 86
6.22 Oct 28, 2015: Cancer Genetics Receives Third Patent for Proprietary Genomic FHACT test, Further Advancing the Detection and Treatment of Cervical and Other HPV-Associated Cancers 87
6.23 Sep 18, 2015: Fast and Reliable Results in Cancer Diagnostics: Biotech Startup Oncgnostics Receives CE Mark for Cervical Cancer Test "GynTect" 87
6.24 Sep 17, 2015: Cancer Genetics to Report Results From Two Independent Studies at the 30th International Papillomavirus Conference & Clinical and Public Health Workshops (HPV 2015) 88
7 Appendix 90
7.1 Methodology 90
7.2 About GlobalData 92
7.3 Contact Us 92
7.4 Disclaimer 93

1.1 List of Tables
Table 1: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 10
Table 2: Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 11
Table 3: Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 12
Table 4: Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 13
Table 5: Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 14
Table 6: Cervical Cancer Diagnostic Tests Companies - Pipeline Products by Stage of Development 15
Table 7: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 17
Table 8: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 19
Table 9: TERC Companion Diagnostic Assay - Cervical Cancer - Product Status 19
Table 10: TERC Companion Diagnostic Assay - Cervical Cancer - Product Description 20
Table 11: Aindra Systems Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 21
Table 12: AIndra Device - Product Status 21
Table 13: AIndra Device - Product Description 22
Table 14: Alere Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
Table 15: NMP179 Test - Product Status 23
Table 16: NMP179 Test - Product Description 24
Table 17: Arbor Vita Corporation Pipeline Products & Ongoing Clinical Trials Overview 25
Table 18: AVantage HPV E6 Test - Product Status 25
Table 19: AVantage HPV E6 Test - Product Description 26
Table 20: Becton, Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview 27
Table 21: BD SurePath Plus Molecular Pap Test System - Product Status 27
Table 22: BD SurePath Plus Molecular Pap Test System - Product Description 28
Table 23: Biomarker-Cervical Cancer - Product Status 28
Table 24: Biomarker-Cervical Cancer - Product Description 28
Table 25: BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29
Table 26: CyPath Diagnostic Assay - Cervical Cancer - Product Status 29
Table 27: CyPath Diagnostic Assay - Cervical Cancer - Product Description 29
Table 28: BioMark Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 30
Table 29: Metabolomics-based Diagnostic Assay - Cervical Cancer - Product Status 30
Table 30: Metabolomics-based Diagnostic Assay - Cervical Cancer - Product Description 30
Table 31: BioMark Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
Table 32: Biomarker Assay - Cervical Cancer - Product Status 31
Table 33: Biomarker Assay - Cervical Cancer - Product Description 31
Table 34: Cancer Research Technology Limited Pipeline Products & Ongoing Clinical Trials Overview 32
Table 35: MCM Test - Cervical Cancer - Product Status 32
Table 36: MCM Test - Cervical Cancer - Product Description 32
Table 37: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 33
Table 38: Xpert Molecular PAP Assay - Product Status 33
Table 39: Xpert Molecular PAP Assay - Product Description 34
Table 40: China Sky One Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35
Table 41: Diagnostic Kit - Carcinoma Cervix - Product Status 35
Table 42: Diagnostic Kit - Carcinoma Cervix - Product Description 36
Table 43: Cytosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 37
Table 44: Laboratory-Based Diagnostic Test - Cervical Cancer - Product Status 37
Table 45: Laboratory-Based Diagnostic Test - Cervical Cancer - Product Description 38
Table 46: Enzo Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39
Table 47: Next-Generation Branched DNA Assay - Cervical Cancer - Product Status 39
Table 48: Next-Generation Branched DNA Assay - Cervical Cancer - Product Description 40
Table 49: Genisphere Inc. Pipeline Products & Ongoing Clinical Trials Overview 41
Table 50: miRNA Biomarker Diagnostic Test - Cervical Cancer - Product Status 41
Table 51: miRNA Biomarker Diagnostic Test - Cervical Cancer - Product Description 41
Table 52: Genomic Vision Pipeline Products & Ongoing Clinical Trials Overview 42
Table 53: HPV Combing Test - Product Status 42
Table 54: HPV Combing Test - Product Description 43
Table 55: Genomic Vision - Ongoing Clinical Trials Overview 44
Table 56: HPV Combing Test - Integration of Oncogenic HPV DNA 45
Table 57: HPV Combing Test - Integration of Oncogenic HPV DNA in Czech Republic 45
Table 58: GenomicTree, Inc. Pipeline Products & Ongoing Clinical Trials Overview 46
Table 59: EarlyTect Cervical Cancer - Product Status 46
Table 60: EarlyTect Cervical Cancer - Product Description 47
Table 61: Screening Test - Cervical Cancer - Product Status 47
Table 62: Screening Test - Cervical Cancer - Product Description 47
Table 63: Golden Valley Development, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48
Table 64: XytoTest - Product Status 48
Table 65: XytoTest - Product Description 48
Table 66: GRANT Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 49
Table 67: Serum-Based Test - Cervical Cancer - Product Status 49
Table 68: Serum-Based Test - Cervical Cancer - Product Description 49
Table 69: Louisville Bioscience, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50
Table 70: Cervical Cancer Remission pT Test - Product Status 50
Table 71: Cervical Cancer Remission pT Test - Product Description 50
Table 72: MDNA Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51
Table 73: Diagnostic Test - Cervical Cancer - Product Status 51
Table 74: Diagnostic Test - Cervical Cancer - Product Description 52
Table 75: MDxHealth SA Pipeline Products & Ongoing Clinical Trials Overview 53
Table 76: ClinicalMDx - Cervical Cancer - Product Status 53
Table 77: ClinicalMDx - Cervical Cancer - Product Description 54
Table 78: Milagen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 55
Table 79: Immunoassay - Cervical Cancer - Product Status 55
Table 80: Immunoassay - Cervical Cancer - Product Description 55
Table 81: NeoDiagnostix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 56
Table 82: Cervical DNA Dtex Test - Product Status 56
Table 83: Cervical DNA Dtex Test - Product Description 56
Table 84: Newcastle University Pipeline Products & Ongoing Clinical Trials Overview 57
Table 85: SmartHEALTH POC System - Cervical Cancer - Product Status 57
Table 86: SmartHEALTH POC System - Cervical Cancer - Product Description 58
Table 87: Oncgnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 59
Table 88: GynTect - Product Status 59
Table 89: GynTect - Product Description 60
Table 90: ONCOVEDA Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 61
Table 91: HPV Companion Diagnostic Test - Cervical Cancer - Product Status 61
Table 92: HPV Companion Diagnostic Test - Cervical Cancer - Product Description 61
Table 93: Orion Genomics LLC Pipeline Products & Ongoing Clinical Trials Overview 62
Table 94: Diagnostic Assay - Cervical Cancer - Product Status 62
Table 95: Diagnostic Assay - Cervical Cancer - Product Description 62
Table 96: Precision Biologics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63
Table 97: Diagnostic Assay - Cervical Cancer - Product Status 63
Table 98: Diagnostic Assay - Cervical Cancer - Product Description 63
Table 99: Preciva Incorporated Pipeline Products & Ongoing Clinical Trials Overview 64
Table 100: mColposcope - Product Status 64
Table 101: mColposcope - Product Description 64
Table 102: Roche Diagnostics International Ltd. Pipeline Products & Ongoing Clinical Trials Overview 65
Table 103: CINtec Plus Cytology Kit - Product Status 65
Table 104: CINtec Plus Cytology Kit - Product Description 65
Table 105: University of Manchester Pipeline Products & Ongoing Clinical Trials Overview 66
Table 106: Diagnostic Test - Cervical Cancer - Product Status 66
Table 107: Diagnostic Test - Cervical Cancer - Product Description 66
Table 108: US Biomarkers, Inc. Pipeline Products & Ongoing Clinical Trials Overview 67
Table 109: Blood-Based Biomarker - Cervical Cancer - Product Status 67
Table 110: Blood-Based Biomarker - Cervical Cancer - Product Description 67
Table 111: Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 68
Table 112: Companion Diagnostic Assay - Cervical Cancer - Product Status 68
Table 113: Companion Diagnostic Assay - Cervical Cancer - Product Description 68
Table 114: Vigilant Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 69
Table 115: Diagnostic Test - Cervical Cancer - Product Status 69
Table 116: Diagnostic Test - Cervical Cancer - Product Description 69
Table 117: XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 70
Table 118: SCCA - IgM Kit - Cervical Cancer - Product Status 70
Table 119: SCCA - IgM Kit - Cervical Cancer - Product Description 70
Table 120: Glossary 91

1.2 List of Figures
Figure 1: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 10
Figure 2: Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 11
Figure 3: Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 12
Figure 4: Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 13
Figure 5: Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 14


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