Cervical Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2017

Published : Aug-2017

No. of Pages : 102

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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

Filed in: Medical Device

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