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Report Title

Human Papillomavirus Diagnostic Tests - Medical Devices Pipeline Assessment, 2016

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Human Papillomavirus Diagnostic Tests - Medical Devices Pipeline Assessment, 2016


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Human Papillomavirus Diagnostic Tests - Medical Devices Pipeline Assessment, 2016

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Human Papillomavirus Diagnostic Tests - Medical Devices Pipeline Assessment, 2016



Executive Summary

Human Papillomavirus Diagnostic Tests - Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Human Papillomavirus Diagnostic Tests - Medical Devices Pipeline Assessment, 2016" provides an overview of Human Papillomavirus 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 Human Papillomavirus 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 Human Papillomavirus 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 Human Papillomavirus 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 Human Papillomavirus 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 9

2 Introduction 10

2.1 Human Papillomavirus Diagnostic Tests Overview 10

3 Products under Development 11

3.1 Human Papillomavirus Diagnostic Tests - Pipeline Products by Stage of Development 11

3.2 Human Papillomavirus Diagnostic Tests - Pipeline Products by Territory 12

3.3 Human Papillomavirus Diagnostic Tests - Pipeline Products by Regulatory Path 13

3.4 Human Papillomavirus Diagnostic Tests - Pipeline Products by Estimated Approval Date 14

3.5 Human Papillomavirus Diagnostic Tests - Ongoing Clinical Trials 15

4 Human Papillomavirus Diagnostic Tests - Pipeline Products under Development by Companies 16

4.1 Human Papillomavirus Diagnostic Tests Companies - Pipeline Products by Stage of Development 16

4.2 Human Papillomavirus Diagnostic Tests - Pipeline Products by Stage of Development 18

5 Human Papillomavirus Diagnostic Tests Companies and Product Overview 20

5.1 AutoGenomics, Inc. Company Overview 20

5.1.1 AutoGenomics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

5.2 Beckman Coulter, Inc. Company Overview 23

5.2.1 Beckman Coulter, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23

5.3 Becton, Dickinson and Company Company Overview 24

5.3.1 Becton, Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview 24

5.4 Biocartis SA Company Overview 26

5.4.1 Biocartis SA Pipeline Products & Ongoing Clinical Trials Overview 26

5.5 Biomagnetics Diagnostics Corporation (Inactive) Company Overview 27

5.5.1 Biomagnetics Diagnostics Corporation (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 27

5.6 Bioorganic Research and Services S.A. Company Overview 28

5.6.1 Bioorganic Research and Services S.A. Pipeline Products & Ongoing Clinical Trials Overview 28

5.7 Bio-Techne Corp Company Overview 30

5.7.1 Bio-Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 30

5.8 Cepheid Company Overview 33

5.8.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 China Medical Technologies, Inc. Company Overview 35

5.9.1 China Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

5.10 Chronix Biomedical, Inc. Company Overview 37

5.10.1 Chronix Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37

5.11 Co-Diagnostics HBDC, Inc. Company Overview 38

5.11.1 Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

5.12 Enigma Diagnostics Limited Company Overview 39

5.12.1 Enigma Diagnostics Limited Pipeline Products & Ongoing Clinical Trials Overview 39

5.13 Enzo Life Sciences, Inc. Company Overview 40

5.13.1 Enzo Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 40

5.14 Genera Biosystems Limited Company Overview 41

5.14.1 Genera Biosystems Limited Pipeline Products & Ongoing Clinical Trials Overview 41

5.15 German Cancer Research Center Company Overview 44

5.15.1 German Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 44

5.16 Goodgene Inc Company Overview 46

5.16.1 Goodgene Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 Great Basin Corporation Company Overview 47

5.17.1 Great Basin Corporation Pipeline Products & Ongoing Clinical Trials Overview 47

5.18 HEALTH BioMed Co., Ltd. Company Overview 49

5.18.1 HEALTH BioMed Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 49

5.19 Homepoint Testing Company Overview 50

5.19.1 Homepoint Testing Pipeline Products & Ongoing Clinical Trials Overview 50

5.20 IncellDx, Inc. Company Overview 51

5.20.1 IncellDx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

5.21 KogeneBiotech Co Ltd Company Overview 53

5.21.1 KogeneBiotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

5.22 MEDITE Cancer Diagnostics, Inc. Company Overview 54

5.22.1 MEDITE Cancer Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 54

5.23 MedNostic Technologies, LLC Company Overview 56

5.23.1 MedNostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 56

5.24 Molbio Diagnostics Pvt. Ltd. Company Overview 57

5.24.1 Molbio Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57

5.25 New Mexico Cancer Care Alliance Company Overview 58

5.25.1 New Mexico Cancer Care Alliance Pipeline Products & Ongoing Clinical Trials Overview 58

5.26 Novacyt Company Overview 62

5.26.1 Novacyt Pipeline Products & Ongoing Clinical Trials Overview 62

5.27 OncoHealth Corporation Company Overview 64

5.27.1 OncoHealth Corporation Pipeline Products & Ongoing Clinical Trials Overview 64

5.28 Pathogenica, Inc. Company Overview 66

5.28.1 Pathogenica, Inc. Pipeline Products & Ongoing Clinical Trials Overview 66

5.29 Provista Diagnostics Inc. Company Overview 67

5.29.1 Provista Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 67

5.30 Quidel Corporation Company Overview 69

5.30.1 Quidel Corporation Pipeline Products & Ongoing Clinical Trials Overview 69

5.31 Rheonix, Inc. Company Overview 71

5.31.1 Rheonix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 71

5.32 Roche Diagnostics International Ltd. Company Overview 72

5.32.1 Roche Diagnostics International Ltd. Pipeline Products & Ongoing Clinical Trials Overview 72

5.33 Roche Molecular Systems, Inc. Company Overview 75

5.33.1 Roche Molecular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 75

5.34 Sansure Biotech Inc Company Overview 77

5.34.1 Sansure Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 77

5.35 Seattle Children's Research Institute Company Overview 79

5.35.1 Seattle Children's Research Institute Pipeline Products & Ongoing Clinical Trials Overview 79

5.36 Seegene, Inc. Company Overview 80

5.36.1 Seegene, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80

5.37 Sequenom, Inc. Company Overview 82

5.37.1 Sequenom, Inc. Pipeline Products & Ongoing Clinical Trials Overview 82

5.38 The Feinstein Institute for Medical Research Company Overview 85

5.38.1 The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 85

5.39 The University of Queensland Company Overview 86

5.39.1 The University of Queensland Pipeline Products & Ongoing Clinical Trials Overview 86

5.40 TrovaGene, Inc. Company Overview 87

5.40.1 TrovaGene, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87

5.41 University of Texas at Austin Company Overview 89

5.41.1 University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 89

5.42 ValiRx Plc Company Overview 90

5.42.1 ValiRx Plc Pipeline Products & Ongoing Clinical Trials Overview 90

5.43 Yale University Company Overview 92

5.43.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview 92

6 Human Papillomavirus Diagnostic Tests - Recent Developments 94

6.1 Sep 27, 2016: ValiRx: Half Yearly Report for the Period Ended 30 June 2016 94

6.2 Sep 13, 2016: ValiRx: Quarterly Update On Clinical Developments 96

6.3 Sep 06, 2016: BD Submits Pre-Market Approval Application to FDA for BD Onclarity HPV Test 97

6.4 Sep 02, 2016: Danaher to Acquire Cepheid 97

6.5 Aug 04, 2016: Trovagene Reports Second Quarter 2016 Financial Results and Accomplishments 98

6.6 Aug 04, 2016: BD Announces Results For 2016 Third Fiscal Quarter 99

6.7 Jul 28, 2016: QIAGEN Reports Results for Second Quarter of 2016; Increased Commitment to Return $300 Million of Capital to Shareholders by End-2017 100

6.8 Jul 28, 2016: BD Names R. Andrew Eckert To Board Of Directors 103

6.9 Jul 28, 2016: Cepheid Reports Second Quarter 2016 Results 104

6.10 Jul 27, 2016: Hologic Announces Financial Results for Third Quarter of Fiscal 2016 104

6.11 Jul 27, 2016: Quidel Reports Second Quarter 2016 Financial Results 106

6.12 Jul 11, 2016: David Coorey Joins Agena Bioscience to Lead Europe, Middle East, and Africa Business 107

6.13 Jul 06, 2016: Bio-Techne Acquires Advanced Cell Diagnostics 108

6.14 Jul 04, 2016: Exiqon - Nomination of candidates for the supervisory board 108

6.15 Jun 21, 2016: Genera Biosystems provides update on PapType HPV test 108

6.16 May 25, 2016: MEDITE Cancer Diagnostics Raises USD0.15 Million in Venture Financing 109

6.17 May 10, 2016: Trovagene Announces First Quarter 2016 Financial Results 109

6.18 May 09, 2016: Novacyt Enters into Clinical Trial Agreement with St Stephen's AIDS Trust 110

6.19 Feb 15, 2016: Novacyt to Collaborate to Validate HPV Testing with NOVAprep Technology 110

6.20 Feb 03, 2016: NEUMANN Diagnostics' automated cervical cancer test achieves exceptional accuracy 111

6.21 Feb 01, 2016: Updated cervical cancer screening guidelines from leading ob-gyn society support expanded use of cobas HPV Test for primary screening 111

6.22 Jan 04, 2016: Seegene's HPV DNA assay proves its excellent performance in WHO global HPV LabNet study 112

6.23 Nov 12, 2015: New Modeling Analysis Shows Screening for Cervical Cancer with Pap+HPV Together Could Provide Better Clinical and Economic Outcomes than Screening with HPV Alone 112

6.24 Oct 12, 2015: Roche Wins the first HPV Primary Screening Tender in Europe 114

7 Appendix 115

7.1 Methodology 115

7.2 About GlobalData 117

7.3 Contact Us 117

7.4 Disclaimer 118

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

1.2 List of Figures

Figure 1: Human Papillomavirus Diagnostic Tests - Pipeline Products by Stage of Development 11

Figure 2: Human Papillomavirus Diagnostic Tests - Pipeline Products by Territory 12

Figure 3: Human Papillomavirus Diagnostic Tests - Pipeline Products by Regulatory Path 13

Figure 4: Human Papillomavirus Diagnostic Tests - Pipeline Products by Estimated Approval Date 14

Figure 5: Human Papillomavirus Diagnostic Tests - Ongoing Clinical Trials 15

1.1 List of Tables

Table 1: Human Papillomavirus Diagnostic Tests - Pipeline Products by Stage of Development 11

Table 2: Human Papillomavirus Diagnostic Tests - Pipeline Products by Territory 12

Table 3: Human Papillomavirus Diagnostic Tests - Pipeline Products by Regulatory Path 13

Table 4: Human Papillomavirus Diagnostic Tests - Pipeline Products by Estimated Approval Date 14

Table 5: Human Papillomavirus Diagnostic Tests - Ongoing Clinical Trials 15

Table 6: HPV Companies - Pipeline Products by Stage of Development 16

Table 7: Human Papillomavirus Diagnostic Tests - Pipeline Products by Stage of Development 18

Table 8: AutoGenomics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

Table 9: INFINITI HPV Genotyping Assay - Product Status 20

Table 10: INFINITI HPV Genotyping Assay - Product Description 21

Table 11: INFINITI HPV-HR Quad Assay - Product Status 21

Table 12: INFINITI HPV-HR Quad Assay - Product Description 22

Table 13: Beckman Coulter, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23

Table 14: DxN VERIS HPV Assay - Product Status 23

Table 15: DxN VERIS HPV Assay - Product Description 23

Table 16: Becton, Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview 24

Table 17: BD Max HPV Assay - Product Status 24

Table 18: BD Max HPV Assay - Product Description 25

Table 19: BD Onclarity HPV Assay - Product Status 25

Table 20: BD Onclarity HPV Assay - Product Description 25

Table 21: Biocartis SA Pipeline Products & Ongoing Clinical Trials Overview 26

Table 22: Idylla HPV Test - Head & Neck Cancer - Product Status 26

Table 23: Idylla HPV Test - Head & Neck Cancer - Product Description 26

Table 24: Biomagnetics Diagnostics Corporation (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 27

Table 25: Diagnostic Test - HPV - Product Status 27

Table 26: Diagnostic Test - HPV - Product Description 27

Table 27: Bioorganic Research and Services S.A. Pipeline Products & Ongoing Clinical Trials Overview 28

Table 28: BNTIVD002 Assay - HPV Immune Response Monitoring - Product Status 28

Table 29: BNTIVD002 Assay - HPV Immune Response Monitoring - Product Description 29

Table 30: Bio-Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 30

Table 31: RNAscope HPV Assay - Cervical Cancer - Product Status 30

Table 32: RNAscope HPV Assay - Cervical Cancer - Product Description 31

Table 33: RNAscope HPV Assay - Head and Neck Cancer - Product Status 31

Table 34: RNAscope HPV Assay - Head and Neck Cancer - Product Description 32

Table 35: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 33

Table 36: GeneXpert - Xpert HPV CLIA Waived - Product Status 33

Table 37: GeneXpert - Xpert HPV CLIA Waived - Product Description 34

Table 38: China Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

Table 39: SPR Based DNA Chip - Sexually Transmitted Diseases - Product Status 35

Table 40: SPR Based DNA Chip - Sexually Transmitted Diseases - Product Description 36

Table 41: Chronix Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37

Table 42: Companion Diagnostic Test - HPV - Product Status 37

Table 43: Companion Diagnostic Test - HPV - Product Description 37

Table 44: Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

Table 45: Diagnostic Test - HPV - Product Status 38

Table 46: Diagnostic Test - HPV - Product Description 38

Table 47: Enigma Diagnostics Limited Pipeline Products & Ongoing Clinical Trials Overview 39

Table 48: Enigma MiniLab - HPV - Product Status 39

Table 49: Enigma MiniLab - HPV - Product Description 39

Table 50: Enzo Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 40

Table 51: Next-Generation Branched DNA Assay - HPV - Product Status 40

Table 52: Next-Generation Branched DNA Assay - HPV - Product Description 40

Table 53: Genera Biosystems Limited Pipeline Products & Ongoing Clinical Trials Overview 41

Table 54: PapType - Product Status 41

Table 55: PapType - Product Description 42

Table 56: PapType SP - Product Status 42

Table 57: PapType SP - Product Description 43

Table 58: German Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 44

Table 59: HPV Genotyping Assay - Cervical Cancer - Product Status 44

Table 60: HPV Genotyping Assay - Cervical Cancer - Product Description 45

Table 61: Goodgene Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Table 62: GG HPV DNA Genotyping Chip - Product Status 46

Table 63: GG HPV DNA Genotyping Chip - Product Description 46

Table 64: Great Basin Corporation Pipeline Products & Ongoing Clinical Trials Overview 47

Table 65: Diagnostic Test - Human Papilloma Virus - Product Status 47

Table 66: Diagnostic Test - Human Papilloma Virus - Product Description 48

Table 67: HEALTH BioMed Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 49

Table 68: 3500Dx Genetic Analyzer - SureX HPV 25 Genotyping Assay Kit - Product Status 49

Table 69: 3500Dx Genetic Analyzer - SureX HPV 25 Genotyping Assay Kit - Product Description 49

Table 70: Homepoint Testing Pipeline Products & Ongoing Clinical Trials Overview 50

Table 71: HPV-Inform - Product Status 50

Table 72: HPV-Inform - Product Description 50

Table 73: IncellDx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

Table 74: HPV OncoTect mRNA - Product Status 51

Table 75: HPV OncoTect mRNA - Product Description 52

Table 76: KogeneBiotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

Table 77: SuperFast HPV Low risk 5 Multiplex Real-time PCR Kit - Product Status 53

Table 78: SuperFast HPV Low risk 5 Multiplex Real-time PCR Kit - Product Description 53

Table 79: MEDITE Cancer Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 54

Table 80: Diagnostic Assay - HPV - Product Status 54

Table 81: Diagnostic Assay - HPV - Product Description 55

Table 82: MedNostic Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 56

Table 83: MedNetic HPV Immunoassay - Product Status 56

Table 84: MedNetic HPV Immunoassay - Product Description 56

Table 85: Molbio Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57

Table 86: Truenat HPV - Product Status 57

Table 87: Truenat HPV - Product Description 57

Table 88: New Mexico Cancer Care Alliance Pipeline Products & Ongoing Clinical Trials Overview 58

Table 89: Exosome Test - HPV Positive Oropharyngeal Squamous Cell Carcinoma - Product Status 58

Table 90: Exosome Test - HPV Positive Oropharyngeal Squamous Cell Carcinoma - Product Description 59

Table 91: New Mexico Cancer Care Alliance - Ongoing Clinical Trials Overview 60

Table 92: Exosome Test - HPV Positive Oropharyngeal Squamous Cell Carcinoma - An Observational, Single-Institution Pilot/Feasibility Study of Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma 61

Table 93: Novacyt Pipeline Products & Ongoing Clinical Trials Overview 62

Table 94: Genesig Kit - Human Papillomavirus 16 - Product Status 62

Table 95: Genesig Kit - Human Papillomavirus 16 - Product Description 63

Table 96: OncoHealth Corporation Pipeline Products & Ongoing Clinical Trials Overview 64

Table 97: HPV E6 Analyte Specific Reagents Kit - Product Status 64

Table 98: HPV E6 Analyte Specific Reagents Kit - Product Description 64

Table 99: HPV E7 Analyte Specific Reagents Kit - Product Status 65

Table 100: HPV E7 Analyte Specific Reagents Kit - Product Description 65

Table 101: Pathogenica, Inc. Pipeline Products & Ongoing Clinical Trials Overview 66

Table 102: HPV Strain Genotyping Test - Product Status 66

Table 103: HPV Strain Genotyping Test - Product Description 66

Table 104: Provista Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 67

Table 105: Blood-Based Diagnostic Test - Cervical Cancer - Product Status 67

Table 106: Blood-Based Diagnostic Test - Cervical Cancer - Product Description 67

Table 107: Blood-Based Diagnostic Test - Oropharyngeal Cancer - Product Status 68

Table 108: Blood-Based Diagnostic Test - Oropharyngeal Cancer - Product Description 68

Table 109: Quidel Corporation Pipeline Products & Ongoing Clinical Trials Overview 69

Table 110: IsoAmp Assay - HPV - Product Status 69

Table 111: IsoAmp Assay - HPV - Product Description 70

Table 112: Rheonix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 71

Table 113: Rheonix CARD HPV Assay - Product Status 71

Table 114: Rheonix CARD HPV Assay - Product Description 71

Table 115: Roche Diagnostics International Ltd. Pipeline Products & Ongoing Clinical Trials Overview 72

Table 116: Amplicor HPV Kit - Product Status 72

Table 117: Amplicor HPV Kit - Product Description 73

Table 118: Cobas 6800 System - HPV Assay - Product Status 73

Table 119: Cobas 6800 System - HPV Assay - Product Description 73

Table 120: Cobas 8800 System - HPV Assay - Product Status 74

Table 121: Cobas 8800 System - HPV Assay - Product Description 74

Table 122: Roche Molecular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 75

Table 123: LINEAR ARRAY HPV Genotyping Test - Product Status 75

Table 124: LINEAR ARRAY HPV Genotyping Test - Product Description 76

Table 125: Sansure Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 77

Table 126: 15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit - Product Status 77

Table 127: 15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit - Product Description 77

Table 128: 15 High-risk Human Papillomavirus DNA Genotyping Diagnostic Kit - Product Status 78

Table 129: 15 High-risk Human Papillomavirus DNA Genotyping Diagnostic Kit - Product Description 78

Table 130: Seattle Children’s Research Institute Pipeline Products & Ongoing Clinical Trials Overview 79

Table 131: Diagnostic Test - High Risk HPV - Product Status 79

Table 132: Diagnostic Test - High Risk HPV - Product Description 79

Table 133: Seegene, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80

Table 134: Anyplex II HPV HR - Product Status 80

Table 135: Anyplex II HPV HR - Product Description 81

Table 136: Sequenom, Inc. Pipeline Products & Ongoing Clinical Trials Overview 82

Table 137: AttoSense HPV Test - Product Status 82

Table 138: AttoSense HPV Test - Product Description 83

Table 139: AttoSense HPV-G Test - Product Status 83

Table 140: AttoSense HPV-G Test - Product Description 83

Table 141: AttoSense HPV-Q Test - Product Status 84

Table 142: AttoSense HPV-Q Test - Product Description 84

Table 143: The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 85

Table 144: Cervical HPV Staining Kit - Product Status 85

Table 145: Cervical HPV Staining Kit - Product Description 85

Table 146: The University of Queensland Pipeline Products & Ongoing Clinical Trials Overview 86

Table 147: Diagnostic Test - HPV Linked Head and Neck Cancer - Product Status 86

Table 148: Diagnostic Test - HPV Linked Head and Neck Cancer - Product Description 86

Table 149: TrovaGene, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87

Table 150: HPV Diagnostic Test - Men - Product Status 87

Table 151: HPV Diagnostic Test - Men - Product Description 88

Table 152: University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 89

Table 153: Personalized Genomic Test - Cervical Cancer - Product Status 89

Table 154: Personalized Genomic Test - Cervical Cancer - Product Description 89

Table 155: ValiRx Plc Pipeline Products & Ongoing Clinical Trials Overview 90

Table 156: Diagnostic Test - HPV - Product Status 90

Table 157: Diagnostic Test - HPV - Product Description 91

Table 158: Yale University Pipeline Products & Ongoing Clinical Trials Overview 92

Table 159: Diagnostic Assay - Cervical Cancer - Product Status 92

Table 160: Diagnostic Assay - Cervical Cancer - Product Description 93

Table 161: Glossary 116

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AutoGenomics, Inc.

Beckman Coulter, Inc.

Becton, Dickinson and Company

Biocartis SA

Biomagnetics Diagnostics Corporation

Bioorganic Research and Services S.A.

Bio-Techne Corp

Cepheid

China Medical Technologies, Inc.

Chronix Biomedical, Inc.

Co-Diagnostics HBDC, Inc.

Enigma Diagnostics Limited

Enzo Life Sciences, Inc.

Genera Biosystems Limited

German Cancer Research Center

Goodgene Inc

Great Basin Corporation

HEALTH BioMed Co., Ltd.

Homepoint Testing

IncellDx, Inc.

KogeneBiotech Co Ltd

MEDITE Cancer Diagnostics, Inc.

MedNostic Technologies, LLC

Molbio Diagnostics Pvt. Ltd.

New Mexico Cancer Care Alliance

Novacyt

OncoHealth Corporation

Pathogenica, Inc.

Provista Diagnostics Inc.

Quidel Corporation

Rheonix, Inc.

Roche Diagnostics International Ltd.

Roche Molecular Systems, Inc.

Sansure Biotech Inc

Seattle Children's Research Institute

Seegene, Inc.

Sequenom, Inc.

The Feinstein Institute for Medical Research

The University of Queensland

TrovaGene, Inc.

University of Texas at Austin

ValiRx Plc

Yale University


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