Cervical Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2017

 Published On: Aug, 2017 |    No of Pages: 102 |  Published By: GlobalData | Format: PDF
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Summary

GlobalData's Medical Devices sector report, “Cervical Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2017" 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 7
2 Introduction 8
2.1 Cervical Cancer Diagnostic Tests Overview 8
3 Products under Development 9
3.1 Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 9
3.2 Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 10
3.3 Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 11
3.4 Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 12
3.5 Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 13
4 Cervical Cancer Diagnostic Tests - Pipeline Products under Development by Companies 14
4.1 Cervical Cancer Diagnostic Tests Companies - Pipeline Products by Stage of Development 14
4.2 Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 16
5 Cervical Cancer Diagnostic Tests Companies and Product Overview 17
5.1 Alere Inc Company Overview 17
5.1.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 17
5.2 Becton Dickinson and Co Company Overview 18
5.2.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 18
5.3 Bio Techne Corp Company Overview 20
5.3.1 Bio Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 20
5.4 BioAffinity Technologies, Inc. Company Overview 21
5.4.1 BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 BioMark Diagnostics Inc. Company Overview 22
5.5.1 BioMark Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 22
5.6 BioMark Technologies Inc Company Overview 23
5.6.1 BioMark Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 23
5.7 Cepheid Company Overview 24
5.7.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 24
5.8 China Sky One Medical Inc Company Overview 25
5.8.1 China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 25
5.9 Cytosystems Ltd Company Overview 26
5.9.1 Cytosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
5.10 Enzo Life Sciences Inc Company Overview 27
5.10.1 Enzo Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 27
5.11 Genisphere LLC Company Overview 28
5.11.1 Genisphere LLC Pipeline Products & Ongoing Clinical Trials Overview 28
5.12 Genomic Vision Company Overview 29
5.12.1 Genomic Vision Pipeline Products & Ongoing Clinical Trials Overview 29
5.13 GenomicTree Inc Company Overview 32
5.13.1 GenomicTree Inc Pipeline Products & Ongoing Clinical Trials Overview 32
5.14 Golden Valley Development, Inc. Company Overview 34
5.14.1 Golden Valley Development, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.15 GRANT Life Sciences, Inc. Company Overview 35
5.15.1 GRANT Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35
5.16 Louisville Bioscience, Inc. Company Overview 36
5.16.1 Louisville Bioscience, Inc. Pipeline Products & Ongoing Clinical Trials Overview 36
5.17 MDNA Life Sciences Inc Company Overview 37
5.17.1 MDNA Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 37
5.18 MDxHealth SA Company Overview 38
5.18.1 MDxHealth SA Pipeline Products & Ongoing Clinical Trials Overview 38
5.19 Milagen Inc Company Overview 39
5.19.1 Milagen Inc Pipeline Products & Ongoing Clinical Trials Overview 39
5.20 Newcastle University Company Overview 40
5.20.1 Newcastle University Pipeline Products & Ongoing Clinical Trials Overview 40
5.21 Olympia Diagnostics, Inc Company Overview 41
5.21.1 Olympia Diagnostics, Inc Pipeline Products & Ongoing Clinical Trials Overview 41
5.22 Oncgnostics GmbH Company Overview 43
5.22.1 Oncgnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 43
5.23 ONCOVEDA Cancer Research Center Company Overview 45
5.23.1 ONCOVEDA Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 45
5.24 Orion Genomics LLC Company Overview 46
5.24.1 Orion Genomics LLC Pipeline Products & Ongoing Clinical Trials Overview 46
5.25 Precision Biologics Inc Company Overview 47
5.25.1 Precision Biologics Inc Pipeline Products & Ongoing Clinical Trials Overview 47
5.26 Preciva Incorporated Company Overview 48
5.26.1 Preciva Incorporated Pipeline Products & Ongoing Clinical Trials Overview 48
5.27 Roche Diagnostics International Ltd Company Overview 49
5.27.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 49
5.28 University of Manchester Company Overview 50
5.28.1 University of Manchester Pipeline Products & Ongoing Clinical Trials Overview 50
5.29 US Biomarkers Inc Company Overview 51
5.29.1 US Biomarkers Inc Pipeline Products & Ongoing Clinical Trials Overview 51
5.30 Vanderbilt University Company Overview 52
5.30.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 52
5.31 XEPTAGEN SpA Company Overview 53
5.31.1 XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 53
6 Cervical Cancer Diagnostic Tests - Recent Developments 54
6.1 Jul 25, 2017: Quest Diagnostics Reports Second Quarter 2017 Financial Results, Raises 2017 Financial Outlook 54
6.2 Jun 15, 2017: Oxford Immunotec Announces Favorable Claim Construction Ruling in Patent Infringement Litigation 54
6.3 Jun 09, 2017: R-way achievement in The 16th IFCPC Congress 54
6.4 Jun 06, 2017: BD Releases 2016 Sustainability Report 55
6.5 Jun 02, 2017: Cancer Genetics to Present at the 7th Annual LD Micro Invitational 55
6.6 May 17, 2017: Mel-Mont Medical announces the development of Mia by XytoTest, a self-collected cervical sample that seeks to eradicate cervical cancer 56
6.7 May 11, 2017: Cancer Genetics Announces 15% Revenue Increase in First Quarter of 2017 over 2016 on Strong Organic Growth While Continuing on Path to Profitability 56
6.8 May 10, 2017: Genomic Vision Announces Promising Preliminary Results for Its Clinical Study in Cervical Cancer Detection in the Czech Republic 58
6.9 May 10, 2017: MEDITE Cancer Diagnostics Announces Reorganization of Germany Operations 59
6.10 May 09, 2017: Genomic Vision: Financial Information at March 31, 2017 59
6.11 May 08, 2017: MDxHealth Trading Update: January to April 2017 60
6.12 May 02, 2017: BD Announces Results For 2017 Second Fiscal Quarter 61
6.13 Apr 28, 2017: MEDITE Cancer Diagnostics Announces Reorganization of Germany Operations 63
6.14 Apr 27, 2017: MEDITE Cancer Diagnostics Appoints Susan Weisman as Chief Financial Officer 64
6.15 Apr 23, 2017: BD Announces Appointment Of Tom Polen As President 64
6.16 Apr 20, 2017: Quest Diagnostics Reports First Quarter 2017 Financial Results, Raises 2017 Financial Outlook 65
6.17 Mar 28, 2017: BD Announces Success of Helping Build Healthy Communities Program, Launches New Effort Focused on Medication Therapy Management 65
6.18 Mar 23, 2017: Cancer Genetics Announces Record Revenue for Fourth Quarter and Full-Year 2016 and Provides 2017 Business Update 65
6.19 Mar 22, 2017: Vigilant Biosciences Announces Multiple Poster Presentations in Support of OncAlert Oral Cancer and OncAlert Labs Product Lines 67
6.20 Mar 21, 2017: Retractable Technologies Announces Litigation Updates 69
6.21 Mar 13, 2017: Cancer Genetics to Present at “A Future Without Cancer Conference” on Friday, March 17 69
6.22 Mar 07, 2017: MEDITE Cancer Diagnostics Appoints Eric M. Goehausen to Board of Directors 69
6.23 Mar 01, 2017: Genomic Vision: 2016 Annual Results 70
6.24 Feb 27, 2017: Bristol-Myers Squibb Expands International Immuno-Oncology Network (II-ON) With Addition of Columbia University Medical Center and Peter MacCallum Cancer Centre 73
6.25 Feb 23, 2017: MDxHealth Reports Financial Year 2016 Results 73
6.26 Feb 02, 2017: BD Announces Results For 2017 First Fiscal Quarter 76
6.27 Jan 26, 2017: Quest Diagnostics Reports Fourth Quarter And Full Year 2016 Financial Results; Provides Guidance For Full Year 2017 78
6.28 Jan 26, 2017: Quest Diagnostics Partners With Montefiore Health System to Deliver High-Value, Innovative Laboratory Services 79
6.29 Jan 09, 2017: MDxHealth Announces Preliminary Update on 2016 Results and Appointment of CFO 79
6.30 Jan 09, 2017: Genomic Vision Doubles Its Installed Base of FiberVision Platforms and Quadruples Its Sales of Products and Services in 2016 80
6.31 Jan 06, 2017: Cancer Genetics Announces Consolidation and Cost Reduction in Administrative and Operational Support Functions 80
6.32 Dec 20, 2016: Singulex Opens European Office and Advances IVD System Evaluation 81
6.33 Dec 16, 2016: MDxHealth Receives ISO 13485:2016 Certification for Dutch Laboratory 82
6.34 Dec 15, 2016: Quest Diagnostics Board of Directors Elects Stephen H. Rusckowski Chairman of the Board 83
6.35 Nov 11, 2016: Quest Diagnostics Raises Revenue Growth Outlook, Increases Dividend at 2016 Investor Day 83
6.36 Nov 10, 2016: Cancer Genetics Announces Strong Third Quarter with 68% Year over Year Revenue Growth and Highlights Path to Future Profitability 84
6.37 Nov 03, 2016: BD Announces Results For 2016 Fourth Fiscal Quarter And Full Year; Provides Fiscal 2017 Guidance 86
6.38 Nov 02, 2016: MDxHealth Provides Third Quarter 2016 Business Update 88
6.39 Oct 20, 2016: Quest Diagnostics Reports Third Quarter 2016 Financial Results 89
6.40 Sep 22, 2016: MDxHealth Announces Upgraded Revenue Forecast 91
6.41 Sep 20, 2016: Early Detection of Ervical cancer: “ GynTect 2.0“- Wider Range of  Application by Using a Greater Variety of Patient Samples 91
6.42 Aug 24, 2016: bioAffinity Awarded New Patent; Company’s Patent Portfolio Continues to Expand 92
6.43 Aug 18, 2016: MDxHealth Reports Second Quarter and First Half 2016 Results 93
6.44 Aug 09, 2016: Cancer Genetics Reports Second Quarter 2016 Financial Results and Provides Company Updates 95
6.45 Aug 04, 2016: BD Announces Results For 2016 Third Fiscal Quarter 96
7 Appendix 99
7.1 Methodology 99
7.2 About GlobalData 102
7.3 Contact Us 102
7.4 Disclaimer 102

1.1 List of Tables
Table 1: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 9
Table 2: Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 10
Table 3: Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 11
Table 4: Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 12
Table 5: Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 13
Table 6: Cervical Cancer Diagnostic Tests Companies - Pipeline Products by Stage of Development 14
Table 7: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 16
Table 8: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 17
Table 9: NMP179 Test - Product Status 17
Table 10: NMP179 Test - Product Description 17
Table 11: Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 18
Table 12: BD SurePath Plus Molecular Pap Test System - Product Status 18
Table 13: BD SurePath Plus Molecular Pap Test System - Product Description 18
Table 14: Biomarker Test - Cervical Cancer - Product Status 19
Table 15: Biomarker Test - Cervical Cancer - Product Description 19
Table 16: Bio Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 20
Table 17: RNAscope HPV Assay - Cervical Cancer - Product Status 20
Table 18: RNAscope HPV Assay - Cervical Cancer - Product Description 20
Table 19: BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
Table 20: CyPath Diagnostic Assay - Cervical Cancer - Product Status 21
Table 21: CyPath Diagnostic Assay - Cervical Cancer - Product Description 21
Table 22: BioMark Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 22
Table 23: Metabolomics-based Diagnostic Assay - Cervical Cancer - Product Status 22
Table 24: Metabolomics-based Diagnostic Assay - Cervical Cancer - Product Description 22
Table 25: BioMark Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 23
Table 26: Biomarker Assay - Cervical Cancer - Product Status 23
Table 27: Biomarker Assay - Cervical Cancer - Product Description 23
Table 28: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 24
Table 29: Xpert Molecular PAP Assay - Product Status 24
Table 30: Xpert Molecular PAP Assay - Product Description 24
Table 31: China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 25
Table 32: Diagnostic Kit - Carcinoma Cervix - Product Status 25
Table 33: Diagnostic Kit - Carcinoma Cervix - Product Description 25
Table 34: Cytosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
Table 35: Laboratory-Based Diagnostic Test - Cervical Cancer - Product Status 26
Table 36: Laboratory-Based Diagnostic Test - Cervical Cancer - Product Description 26
Table 37: Enzo Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 27
Table 38: Next-Generation Branched DNA Assay - Cervical Cancer - Product Status 27
Table 39: Next-Generation Branched DNA Assay - Cervical Cancer - Product Description 27
Table 40: Genisphere LLC Pipeline Products & Ongoing Clinical Trials Overview 28
Table 41: miRNA Biomarker Diagnostic Test - Cervical Cancer - Product Status 28
Table 42: miRNA Biomarker Diagnostic Test - Cervical Cancer - Product Description 28
Table 43: Genomic Vision Pipeline Products & Ongoing Clinical Trials Overview 29
Table 44: HPV Combing Test - Product Status 29
Table 45: HPV Combing Test - Product Description 29
Table 46: Genomic Vision - Ongoing Clinical Trials Overview 30
Table 47: HPV Combing Test - Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution 31
Table 48: HPV Combing Test - Integration of Oncogenic HPV DNA in Czech Republic 31
Table 49: GenomicTree Inc Pipeline Products & Ongoing Clinical Trials Overview 32
Table 50: EarlyTect Cervical Cancer - Product Status 32
Table 51: EarlyTect Cervical Cancer - Product Description 32
Table 52: Screening Test - Cervical Cancer - Product Status 33
Table 53: Screening Test - Cervical Cancer - Product Description 33
Table 54: Golden Valley Development, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 55: XytoTest - Product Status 34
Table 56: XytoTest - Product Description 34
Table 57: GRANT Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35
Table 58: Serum-Based Test - Cervical Cancer - Product Status 35
Table 59: Serum-Based Test - Cervical Cancer - Product Description 35
Table 60: Louisville Bioscience, Inc. Pipeline Products & Ongoing Clinical Trials Overview 36
Table 61: Cervical Cancer Remission pT Test - Product Status 36
Table 62: Cervical Cancer Remission pT Test - Product Description 36
Table 63: MDNA Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 37
Table 64: Diagnostic Test - Cervical Cancer - Product Status 37
Table 65: Diagnostic Test - Cervical Cancer - Product Description 37
Table 66: MDxHealth SA Pipeline Products & Ongoing Clinical Trials Overview 38
Table 67: ClinicalMDx - Cervical Cancer - Product Status 38
Table 68: ClinicalMDx - Cervical Cancer - Product Description 38
Table 69: Milagen Inc Pipeline Products & Ongoing Clinical Trials Overview 39
Table 70: Immunoassay - Cervical Cancer - Product Status 39
Table 71: Immunoassay - Cervical Cancer - Product Description 39
Table 72: Newcastle University Pipeline Products & Ongoing Clinical Trials Overview 40
Table 73: SmartHEALTH POC System - Cervical Cancer - Product Status 40
Table 74: SmartHEALTH POC System - Cervical Cancer - Product Description 40
Table 75: Olympia Diagnostics, Inc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 76: Diagnostic Test - Cervical Cancer - Product Status 41
Table 77: Diagnostic Test - Cervical Cancer - Product Description 41
Table 78: Prognostic Test - Cervical Cancer - Product Status 42
Table 79: Prognostic Test - Cervical Cancer - Product Description 42
Table 80: Oncgnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 43
Table 81: GynTect - Product Status 43
Table 82: GynTect - Product Description 43
Table 83: GynTect 2.0 - Product Status 44
Table 84: GynTect 2.0 - Product Description 44
Table 85: ONCOVEDA Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 45
Table 86: HPV Companion Diagnostic Test - Cervical Cancer - Product Status 45
Table 87: HPV Companion Diagnostic Test - Cervical Cancer - Product Description 45
Table 88: Orion Genomics LLC Pipeline Products & Ongoing Clinical Trials Overview 46
Table 89: Diagnostic Assay - Cervical Cancer - Product Status 46
Table 90: Diagnostic Assay - Cervical Cancer - Product Description 46
Table 91: Precision Biologics Inc Pipeline Products & Ongoing Clinical Trials Overview 47
Table 92: Diagnostic Assay - Cervical Cancer - Product Status 47
Table 93: Diagnostic Assay - Cervical Cancer - Product Description 47
Table 94: Preciva Incorporated Pipeline Products & Ongoing Clinical Trials Overview 48
Table 95: mColposcope - Product Status 48
Table 96: mColposcope - Product Description 48
Table 97: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 49
Table 98: CINtec Plus Cytology Kit - Product Status 49
Table 99: CINtec Plus Cytology Kit - Product Description 49
Table 100: University of Manchester Pipeline Products & Ongoing Clinical Trials Overview 50
Table 101: Diagnostic Test - Cervical Cancer - Product Status 50
Table 102: Diagnostic Test - Cervical Cancer - Product Description 50
Table 103: US Biomarkers Inc Pipeline Products & Ongoing Clinical Trials Overview 51
Table 104: Blood-Based Biomarker - Cervical Cancer - Product Status 51
Table 105: Blood-Based Biomarker - Cervical Cancer - Product Description 51
Table 106: Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 52
Table 107: Companion Diagnostic Assay - Cervical Cancer - Product Status 52
Table 108: Companion Diagnostic Assay - Cervical Cancer - Product Description 52
Table 109: XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 53
Table 110: SCCA - IgM Kit - Cervical Cancer - Product Status 53
Table 111: SCCA - IgM Kit - Cervical Cancer - Product Description 53
Table 112: Glossary 101

1.2 List of Figures
Figure 1: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 9
Figure 2: Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 10
Figure 3: Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 11
Figure 4: Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 12
Figure 5: Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 13


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