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Ovarian Cancer Diagnostic Tests-Medical Devices Pipeline Assessment, 2016

Ovarian Cancer Diagnostic Tests-Medical Devices Pipeline Assessment, 2016


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Executive Summary

Ovarian Cancer Diagnostic Tests-Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Ovarian Cancer Diagnostic Tests-Medical Devices Pipeline Assessment, 2016" provides an overview of Ovarian 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 Ovarian 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 Ovarian 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 Ovarian 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 Ovarian 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 7

1.2 List of Figures 14

2 Introduction 15

2.1 Ovarian Cancer Diagnostic Tests Overview 15

3 Products under Development 16

3.1 Ovarian Cancer Diagnostic Tests-Pipeline Products by Stage of Development 16

3.2 Ovarian Cancer Diagnostic Tests-Pipeline Products by Territory 17

3.3 Ovarian Cancer Diagnostic Tests-Pipeline Products by Regulatory Path 18

3.4 Ovarian Cancer Diagnostic Tests-Pipeline Products by Estimated Approval Date 19

3.5 Ovarian Cancer Diagnostic Tests-Ongoing Clinical Trials 20

4 Ovarian Cancer Diagnostic Tests-Pipeline Products under Development by Companies 21

4.1 Ovarian Cancer Diagnostic Tests Companies-Pipeline Products by Stage of Development 21

4.2 Ovarian Cancer Diagnostic Tests-Pipeline Products by Stage of Development 25

5 Ovarian Cancer Diagnostic Tests Companies and Product Overview 29

5.1 A&G Pharmaceutical, Inc. Company Overview 29

5.2 Abnova Corporation Company Overview 31

5.3 Almac Diagnostics Limited Company Overview 33

5.4 ANGLE plc Company Overview 34

5.5 AroCell AB Company Overview 37

5.6 ArtemixRx Company Overview 38

5.7 Augusta University Company Overview 39

5.8 Aurelium BioPharma Inc. Company Overview 40

5.9 Avant Diagnostics, Inc. Company Overview 43

5.10 Axela Inc. Company Overview 44

5.11 Ayanda Biosystems S.A. Company Overview 45

5.12 Becton, Dickinson and Company Company Overview 46

5.13 Bioindustry Park Silvano Fumero S.p.A. Company Overview 48

5.14 Ceres Nanosciences, Inc. Company Overview 49

5.15 Chronix Biomedical, Inc. Company Overview 51

5.16 Clarient, Inc. Company Overview 52

5.17 ClavGen Therapeutics LLC Company Overview 53

5.18 Cleveland Diagnostics Inc. Company Overview 54

5.19 Clovis Oncology, Inc. Company Overview 55

5.20 Courtagen Life Sciences, Inc. Company Overview 56

5.21 Dako A/S Company Overview 57

5.22 Dana-Farber Cancer Institute, Inc. Company Overview 58

5.23 Diazyme Laboratories Company Overview 59

5.24 Eventus Diagnostics, Inc. Company Overview 63

5.25 Exiqon A/S Company Overview 64

5.26 Exosomics Siena SpA Company Overview 65

5.27 Fahy Gurteen UK Limited Company Overview 66

5.28 Foundation Medicine, Inc. Company Overview 67

5.29 French National Institute of Health and Medical Research Company Overview 69

5.30 Ganymed Pharmaceuticals AG Company Overview 70

5.31 GeneNews Limited Company Overview 71

5.32 Georgia Institute of Technology Company Overview 73

5.33 GlycoZym Company Overview 74

5.34 H. Lee Moffitt Cancer Center & Research Institute, Inc. Company Overview 75

5.35 Ikonisys, Inc. Company Overview 76

5.36 Inanovate (UK) Ltd. Company Overview 77

5.37 InterGenetics Incorporated Company Overview 78

5.38 IV Diagnostics, Inc. Company Overview 79

5.39 John Hopkins University Company Overview 80

5.40 KIYATEC Inc. Company Overview 83

5.41 Lab Discoveries Ltd. Company Overview 84

5.42 Laboratorios SALVAT S.A. Company Overview 85

5.43 Laboratory Corporation of America Holdings Company Overview 86

5.44 Louisville Bioscience, Inc. Company Overview 88

5.45 MabCure Inc. Company Overview 89

5.46 MDNA Life Sciences, Inc. Company Overview 91

5.47 MDxHealth SA Company Overview 93

5.48 Metabolon, Inc. Company Overview 95

5.49 Milagen, Inc. Company Overview 96

5.50 Myriad Genetics, Inc. Company Overview 97

5.51 Nanosphere, Inc. Company Overview 99

5.52 National University of Singapore Company Overview 101

5.53 Novel Bio-spectrum Technologies, Inc. Company Overview 102

5.54 Olympia Diagnostics, Inc Company Overview 103

5.55 Oncgnostics GmbH Company Overview 104

5.56 Oncimmune (USA) LLC Company Overview 105

5.57 Orion Genomics LLC Company Overview 106

5.58 Oryzon Genomics SA Company Overview 107

5.59 OTraces Inc. Company Overview 108

5.60 PeriRx LLC Company Overview 110

5.61 Phenomenome Discoveries, Inc. Company Overview 111

5.62 Precision Biologics, Inc. Company Overview 112

5.63 Pronota NV Company Overview 113

5.64 Protagen AG Company Overview 114

5.65 Proteomika Company Overview 115

5.66 Provista Diagnostics Inc. Company Overview 116

5.67 RiboMed Biotechnologies, Inc. Company Overview 117

5.68 Roche Diagnostics International Ltd. Company Overview 118

5.69 Rosetta Genomics Ltd Company Overview 120

5.70 SomaLogic, Inc. Company Overview 122

5.71 Soricimed Biopharma Inc. Company Overview 124

5.72 Stage I Diagnostics, Inc. Company Overview 126

5.73 SurExam Life Science & Technology Co. Company Overview 127

5.74 Target Discovery, Inc. Company Overview 128

5.75 Teva Pharmaceutical Industries Ltd. Company Overview 129

5.76 The University of Adelaide Company Overview 131

5.77 The University of Texas MD Anderson Cancer Center Company Overview 132

5.78 Todos Medical Company Overview 133

5.79 Transbiomed, SL Company Overview 134

5.80 Universite de Montreal Company Overview 135

5.81 University of South Florida Company Overview 136

5.82 US Biomarkers, Inc. Company Overview 138

5.83 Vermillion, Inc. Company Overview 139

5.84 Vitatex Inc. Company Overview 141

5.85 Vitruvian Biomedical, Inc. Company Overview 143

5.86 Yale University Company Overview 144

6 Ovarian Cancer Diagnostic Tests-Recent Developments 145

6.1 Aug 18, 2016: MDxHealth Reports Second Quarter and First Half 2016 Results 145

6.2 Aug 11, 2016: Metabolon Raises USD15 Million in Venture Financing 147

6.3 Aug 11, 2016: GeneNews Announces Q2-2016 Financial Results 147

6.4 Aug 10, 2016: Vermillion Reports Second Quarter 2016 Results 147

6.5 Aug 09, 2016: Myriad Genetics Reports Fiscal Fourth-Quarter 2016 Financial Results 148

6.6 Aug 08, 2016: Oryzon Reports Financial Results and Corporate Update for the 1st Half Ended June 30, 2016 150

6.7 Aug 08, 2016: Clovis Oncology Announces Q2 2016 Operating Results and Corporate Update 151

6.8 Aug 04, 2016: Teva Reports Second Quarter 2016 Results 153

6.9 Aug 04, 2016: BD Announces Results For 2016 Third Fiscal Quarter 157

6.10 Aug 04, 2016: Tesaro Announces Second-Quarter 2016 Operating Results 159

6.11 Aug 02, 2016: ASPiRA LABS Expands Coverage for OVA1 in California 161

6.12 Aug 02, 2016: Pfizer Reports Second-Quarter 2016 Results 161

6.13 Aug 02, 2016: Foundation Medicine Announces 2016 Second Quarter Results and Recent Highlights 165

6.14 Jul 28, 2016: BD Names R. Andrew Eckert To Board Of Directors 167

6.15 Jul 27, 2016: Angle Announces Initiation Of 200 Patient United States Ovarian Cancer Study 167

6.16 Jul 27, 2016: ASPiRA LABS Expands Coverage for OVA1 in Texas 168

6.17 Jul 27, 2016: Laboratory Corporation of America Holdings Announces 2016 Second Quarter Results and Raises 2016 Guidance 169

6.18 Jul 21, 2016: Teva Pharma Raises USD304 Million in Public Offering of 0.125% Notes Due 2018 171

6.19 Jul 21, 2016: Teva Pharma Raises USD354.6 Million in Public Offering of 1% Notes Due 2025 172

6.20 Jul 21, 2016: Teva Pharma Raises USD354.6 Million in Public Offering of 0.5% Notes Due 2022 172

6.21 Jul 20, 2016: Abbott Reports Second-Quarter 2016 Results 173

6.22 Jul 20, 2016: Protagen Appoints Bernhard Kirschbaum as New Chairman and Oliver Schacht as New Board Member 175

6.23 Jul 19, 2016: Angle Announces Initiation Of Two Hundred Patient European Ovarian Cancer Study 176

6.24 Jul 19, 2016: ASPiRA LABS Announces Strategic Michigan Coverage for OVA1 177

6.25 Jul 19, 2016: Novartis delivered solid Q2 despite full quarter of US Gleevec generic impact; significant positive innovation news strengthens future growth prospects 177

6.26 Jul 18, 2016: Teva Pharma Raises USD3.5 Billion in Public Offering of 3.15% Notes Due 2026 183

6.27 Jul 18, 2016: Teva Pharma Raises USD1.5 Billion in Public Offering of 1.4% Notes Due 2018 184

6.28 Jul 18, 2016: Teva Pharma Raises USD3 Billion in Public Offering of 2.2% Notes Due 2021 184

6.29 Jul 18, 2016: Teva Pharma Raises USD3 Billion in Public Offering of 2.8% Notes Due 2023 185

6.30 Jul 18, 2016: Teva Pharma Raises USD2 Billion in Public Offering of 4.1% Notes Due 2046 185

6.31 Jul 18, 2016: Teva Pharma Raises USD2 Billion in Public Offering of 1.7% Notes Due 2019 186

6.32 Jul 15, 2016: PhRMA Welcomes Five New Member Companies 186

6.33 Jul 13, 2016: Nasdaq Copenhagen accepts Exiqon request for delisting and cancellation from trading of the Exiqon shares 187

6.34 Jul 13, 2016: Simplifying access to gene testing for women with ovarian cancer improves treatment choices and could save lives 187

6.35 Jul 13, 2016: Pfizer and NovaMedica announce a strategic partnership in Russia 189

6.36 Jul 11, 2016: Rosetta Genomics Receives U.S. Patent Allowance for microRNA-based Ovarian Cancer Treatment 190

6.37 Jul 04, 2016: Oncimmune Enters into Research Agreement with Egybiotech and Aarhus University Hospital 190

6.38 Jul 04, 2016: Exiqon Nomination of candidates for the supervisory board 191

6.39 Jun 30, 2016: Tesaro Raises USD433.2 Million in Public Offering of Shares 191

6.40 Jun 30, 2016: Tesaro to Raise up to USD55.8 Million in Public Offering of Shares 191

6.41 Jun 29, 2016: Myriad's myChoice HRD Test Successfully Identifies Patients that Meet Primary Endpoint in TESARO's Pivotal Phase 3 Ovarian Cancer Study with Niraparib 191

6.42 Jun 23, 2016: Oncimmune Appoints Julian Hirst as Non-Executive Director 192

6.43 Jun 16, 2016: Pfizer Breaks Ground On New Biologics Clinical Manufacturing Facility In Andover, Massachusetts 193

6.44 Jun 15, 2016: GeneNews Announces Filing of Q1-2016 Financial Results 193

6.45 Jun 10, 2016: Diadexus to File Chapter 7 194

6.46 Jun 04, 2016: T-Cell Receptor Sequencing Reveals Novel Biomarkers for Ovarian Cancer 195

6.47 May 31, 2016: Pfizer Raises USD1.25 Billion in Public Offering of 1.2% Notes Due 2018 195

6.48 May 31, 2016: Pfizer Raises USD0.85 Billion in Public Offering of 1.45% Notes Due 2019 196

6.49 May 31, 2016: Pfizer Raises USD1.15 Billion in Public Offering of 1.95% Notes Due 2021 196

6.50 May 31, 2016: Pfizer Raises USD1.25 Billion in Public Offering of 2.75% Notes Due 2026 197

6.51 May 31, 2016: Pfizer Raises USD0.5 Billion in Public Offering of 4.4% Notes Due 2044 197

6.52 May 27, 2016: GeneNews Announces Full Year 2015 Financial Results 198

6.53 May 25, 2016: Stage I Diagnostics Raises USD0.1 Million in Venture Financing 199

6.54 May 25, 2016: Novartis highlights its strong foundation for long-term, sustainable growth at the third Meet Novartis Management event 199

6.55 May 24, 2016: COTA Increases Cross-Industry Support With the Addition of Celgene, Foundation Medicine HealthScape Advisors and Novartis as Strategic Investors 201

6.56 May 19, 2016: GeneNews Announces a Further Extension of the TSXs Remedial Review Process 201

6.57 May 17, 2016: Novartis focuses Pharmaceuticals Division by creating two business units, Novartis Pharmaceuticals and Novartis Oncology; appoints leaders to the Executive Committee of Novartis 202

6.58 May 16, 2016: Vermillion to Showcase Comparison of Overa and ROMA Algorithms at ACOG 2016 Annual Meeting 202

6.59 May 16, 2016: Nanosphere Announces First Quarter Results 203

6.60 May 16, 2016: Vermillion Reports First Quarter 2016 Results 204

6.61 May 16, 2016: Vermillion Reports Fourth Quarter and Full Year 2015 Results 205

6.62 May 15, 2016: Luminex Acquires Nanosphere in Tender Offer 206

6.63 May 12, 2016: Phenomenome Discoveries Announces the Successful Validation of OvAware, a simple blood test for the Early Detection of Ovarian Cancer 207

6.64 May 12, 2016: Oryzon Reports First Quarter 2016 Financial Results and Corporate Update 208

6.65 May 09, 2016: Teva Reports First Quarter 2016 Results 208

6.66 Apr 27, 2016: A.G. Schneiderman Announces Multistate And Federal Settlement With Wyeth And Pfizer For $784.6m To Resolve Allegations Of Underpaying Rebates Owed Through The Medicaid Drug Rebate Program 212

6.67 Mar 21, 2016: Vermillion Announces FDA Clearance of Overa, Second Generation OVA1 Test 213

6.68 Mar 15, 2016: Caris Life Sciences to Present Molecular Insights Informing Treatment Strategies at the 2016 Society of Gynecologic Oncology Annual Meeting 214

6.69 Mar 07, 2016: MDNA set to launch slew of new blood-based cancer tests 215

6.70 Mar 01, 2016: Multiplicom first in Europe to obtain CE-IVD for ovarian cancer companion diagnostic 217

6.71 Feb 16, 2016: Vermillion Teams up With NASCAR Driver Martin Truex, Jr. and Partner Sherry Pollex, an Ovarian Cancer Thriver, to "Accelerate" the National Conversation about Ovarian Cancer and OVA1 217

6.72 Feb 09, 2016: Vermillion Lands America's Most Decorated Gymnast and Ovarian Cancer Survivor, Shannon Miller, for its OVA1 Awareness Team 218

6.73 Jan 28, 2016: Avera Medical Group and Epic Sciences collaborate on cancer precision medicine clinical trials 219

6.74 Jan 26, 2016: Abcodia Announces Expanded U.S. Availability of the ROCA Test for Early Ovarian Cancer Detection 219

6.75 Jan 14, 2016: Genomic Vision to demonstrate 'molecular combing' technology's ability to identify novel cancer-causing BRCA gene variants 221

6.76 Jan 11, 2016: Vermillion Exits 2015 with 33M Lives Covered for OVA1 222

6.77 Jan 11, 2016: Abcodia Restructures Leadership Team to Drive Commercialization of the ROCA Test 222

6.78 Dec 17, 2015: Data Published in The Lancet Suggest New Ovarian Cancer Screening Test Reduces Mortality 223

6.79 Dec 02, 2015: Abcodia Announces Initial U.S. Availability of the ROCA Test to Aid in the Early Detection of Ovarian Cancer 225

6.80 Dec 01, 2015: Vermillion Announces Key Medical Policy Coverage by Medi-Cal for OVA1 Test 226

6.81 Nov 09, 2015: Vermillion Announces Decision by NICE to End MIB Pause for OVA1 Due to CE Mark of Overa 227

6.82 Oct 26, 2015: Vermillion Announces CE Mark for Overa, the Next Generation OVA1 Test 228

6.83 Oct 07, 2015: Avant Diagnostics Receives FDA IRB Approval for OvaDx Ovarian Cancer Validation Test Specimens 228

6.84 Sep 28, 2015: Caris Molecular Intelligence Tumor Profiling Identifies Potential Responders to Anticancer Therapy Across a Range of Tumor Types 229

6.85 Sep 24, 2015: Myriad Genetics Presents New Data on Its myChoice HRD at the European Society for Medical Oncology Annual Meeting 230

6.86 Sep 24, 2015: Avant Diagnostics Commences OvaDx Ovarian Cancer Test Calibration in Preparation for FDA Submission 231

7 Appendix 232

7.1 Methodology 232

7.2 About GlobalData 234

7.3 Contact Us 235

7.4 Disclaimer 23

1.2 List of Figures

Figure 1: Ovarian Cancer Diagnostic Tests-Pipeline Products by Stage of Development 18

Figure 2: Ovarian Cancer Diagnostic Tests-Pipeline Products by Territory 19

Figure 3: Ovarian Cancer Diagnostic Tests-Pipeline Products by Regulatory Path 20

Figure 4: Ovarian Cancer Diagnostic Tests-Pipeline Products by Estimated Approval Date 21

Figure 5: Ovarian Cancer Diagnostic Tests-Ongoing Clinical Trials 22

1.1 List of Tables

Table 1: Ovarian Cancer Diagnostic Tests-Pipeline Products by Stage of Development 18

Table 2: Ovarian Cancer Diagnostic Tests-Pipeline Products by Territory 19

Table 3: Ovarian Cancer Diagnostic Tests-Pipeline Products by Regulatory Path 20

Table 4: Ovarian Cancer Diagnostic Tests-Pipeline Products by Estimated Approval Date 21

Table 5: Ovarian Cancer Diagnostic Tests-Ongoing Clinical Trials 22

Table 6: Ovarian Cancer Diagnostic Tests Companies-Pipeline Products by Stage of Development 23

Table 7: Ovarian Cancer Diagnostic Tests-Pipeline Products by Stage of Development 27

Table 8: A&G Pharmaceutical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 31

Table 9: Companion Diagnostic Test-Ovarian Cancer-Product Status 31

Table 10: Companion Diagnostic Test-Ovarian Cancer-Product Description 32

Table 11: Abnova Corporation Pipeline Products & Ongoing Clinical Trials Overview 33

Table 12: Biomarker Test-Ovarian Cancer-Product Status 33

Table 13: Biomarker Test-Ovarian Cancer-Product Description 34

Table 14: Almac Diagnostics Limited Pipeline Products & Ongoing Clinical Trials Overview 35

Table 15: Diagnostic Test-Ovarian Cancer-Product Status 35

Table 16: Diagnostic Test-Ovarian Cancer-Product Description 35

Table 17: ANGLE plc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 18: Parsortix-Based Test-Ovarian Cancer-Product Status 36

Table 19: Parsortix-Based Test-Ovarian Cancer-Product Description 36

Table 20: ANGLE plc-Ongoing Clinical Trials Overview 37

Table 21: Parsortix-Based Test-Ovarian Cancer-ANG-001 Pelvic Mass Training Study: Evaluation of Multiple Circulating Tumor Cell-derived RNA Markers to Estimate Risk of Ovarian Cancer in Patients Presenting with a Pelvic Mass. 38

Table 22: Parsortix-Based Test-Ovarian Cancer-United States Ovarian Cancer Study 38

Table 23: AroCell AB Pipeline Products & Ongoing Clinical Trials Overview 39

Table 24: TK 210 Assay-Ovarian Cancer-Product Status 39

Table 25: TK 210 Assay-Ovarian Cancer-Product Description 39

Table 26: ArtemixRx Pipeline Products & Ongoing Clinical Trials Overview 40

Table 27: ArtemixRx Prognostic Test-Ovarian Cancer-Product Status 40

Table 28: ArtemixRx Prognostic Test-Ovarian Cancer-Product Description 40

Table 29: Augusta University Pipeline Products & Ongoing Clinical Trials Overview 41

Table 30: Biomarker Test-Ovarian Cancer-Product Status 41

Table 31: Biomarker Test-Ovarian Cancer-Product Description 41

Table 32: Aurelium BioPharma Inc. Pipeline Products & Ongoing Clinical Trials Overview 42

Table 33: MMD ELISA Test-Ovarian Cancer-Product Status 42

Table 34: MMD ELISA Test-Ovarian Cancer-Product Description 42

Table 35: MMD QPCR Test-Ovarian cancer-Product Status 43

Table 36: MMD QPCR Test-Ovarian cancer-Product Description 43

Table 37: Ovarian Cancer Screening Test-Product Status 43

Table 38: Ovarian Cancer Screening Test-Product Description 44

Table 39: Avant Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 45

Table 40: OvaDx-Product Status 45

Table 41: OvaDx-Product Description 45

Table 42: Axela Inc. Pipeline Products & Ongoing Clinical Trials Overview 46

Table 43: Multiplex Ovarian Cancer Biomarker Assay-Product Status 46

Table 44: Multiplex Ovarian Cancer Biomarker Assay-Product Description 46

Table 45: Ayanda Biosystems S.A. Pipeline Products & Ongoing Clinical Trials Overview 47

Table 46: Diagnostic Test-Ovarian Cancer-Product Status 47

Table 47: Diagnostic Test-Ovarian Cancer-Product Description 47

Table 48: Becton, Dickinson and Company Pipeline Products & Ongoing Clinical Trials Overview 48

Table 49: Diagnostic Test-Ovarian Cancer-Product Status 48

Table 50: Diagnostic Test-Ovarian Cancer-Product Description 49

Table 51: Bioindustry Park Silvano Fumero S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 50

Table 52: Diagnostic Kit-Ovarian Cancer-Product Status 50

Table 53: Diagnostic Kit-Ovarian Cancer-Product Description 50

Table 54: Ceres Nanosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

Table 55: Nanotrap Ovarian Cancer Biomarker Test-Product Status 51

Table 56: Nanotrap Ovarian Cancer Biomarker Test-Product Description 52

Table 57: Chronix Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 53

Table 58: Companion Diagnostic Test-Ovarian Cancer-Product Status 53

Table 59: Companion Diagnostic Test-Ovarian Cancer-Product Description 53

Table 60: Clarient, Inc. Pipeline Products & Ongoing Clinical Trials Overview 54

Table 61: Ovatax-Product Status 54

Table 62: Ovatax-Product Description 54

Table 63: ClavGen Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 55

Table 64: Prognostic Assay-Ovarian Cancer-Product Status 55

Table 65: Prognostic Assay-Ovarian Cancer-Product Description 55

Table 66: Cleveland Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 56

Table 67: Blood-Based Diagnostic Test-Ovarian Cancer-Product Status 56

Table 68: Blood-Based Diagnostic Test-Ovarian Cancer-Product Description 56

Table 69: Clovis Oncology, Inc. Pipeline Products & Ongoing Clinical Trials Overview 57

Table 70: Rucaparib Companion Diagnostic Test-Product Status 57

Table 71: Rucaparib Companion Diagnostic Test-Product Description 57

Table 72: Courtagen Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

Table 73: Ovarian Cancer Diagnostic Panel-Product Status 58

Table 74: Ovarian Cancer Diagnostic Panel-Product Description 58

Table 75: Dako A/S Pipeline Products & Ongoing Clinical Trials Overview 59

Table 76: MK-8109 Companion Diagnostic Test-Product Status 59

Table 77: MK-8109 Companion Diagnostic Test-Product Description 59

Table 78: Dana-Farber Cancer Institute, Inc. Pipeline Products & Ongoing Clinical Trials Overview 60

Table 79: Biomarker Assay-Ovarian Carcinoma-Product Status 60

Table 80: Biomarker Assay-Ovarian Carcinoma-Product Description 60

Table 81: Diazyme Laboratories Pipeline Products & Ongoing Clinical Trials Overview 61

Table 82: B7-H4 Assay-Product Status 61

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A&G Pharmaceutical, Inc.

Abnova Corporation

Almac Diagnostics Limited

ANGLE plc

AroCell AB

ArtemixRx

Augusta University

Aurelium BioPharma Inc.

Avant Diagnostics, Inc.

Axela Inc.

Ayanda Biosystems S.A.

Becton, Dickinson and Company

Bioindustry Park Silvano Fumero S.p.A.

Ceres Nanosciences, Inc.

Chronix Biomedical, Inc.

Clarient, Inc.

ClavGen Therapeutics LLC

Cleveland Diagnostics Inc.

Clovis Oncology, Inc.

Courtagen Life Sciences, Inc.

Dako A/S

Dana-Farber Cancer Institute, Inc.

Diazyme Laboratories

Eventus Diagnostics, Inc.

Exiqon A/S

Exosomics Siena SpA

Fahy Gurteen UK Limited

Foundation Medicine, Inc.

French National Institute of Health and Medical Research

Ganymed Pharmaceuticals AG

GeneNews Limited

Georgia Institute of Technology

GlycoZym

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Ikonisys, Inc.

Inanovate (UK) Ltd.

InterGenetics Incorporated

IV Diagnostics, Inc.

John Hopkins University

KIYATEC Inc.

Lab Discoveries Ltd.

Laboratorios SALVAT S.A.

Laboratory Corporation of America Holdings

Louisville Bioscience, Inc.

MabCure Inc.

MDNA Life Sciences, Inc.

MDxHealth SA

Metabolon, Inc.

Milagen, Inc.

Myriad Genetics, Inc.

Nanosphere, Inc.

National University of Singapore

Novel Bio-spectrum Technologies, Inc.

Olympia Diagnostics, Inc

Oncgnostics GmbH

Oncimmune (USA) LLC

Orion Genomics LLC

Oryzon Genomics SA

OTraces Inc.

PeriRx LLC

Phenomenome Discoveries, Inc.

Precision Biologics, Inc.

Pronota NV

Protagen AG

Proteomika

Provista Diagnostics Inc.

RiboMed Biotechnologies, Inc.

Roche Diagnostics International Ltd.

Rosetta Genomics Ltd

SomaLogic, Inc.

Soricimed Biopharma Inc.

Stage I Diagnostics, Inc.

SurExam Life Science & Technology Co.

Target Discovery, Inc.

Teva Pharmaceutical Industries Ltd.

The University of Adelaide

The University of Texas MD Anderson Cancer Center

Todos Medical

Transbiomed, SL

Universite de Montreal

University of South Florida

US Biomarkers, Inc.

Vermillion, Inc.

Vitatex Inc.

Vitruvian Biomedical, Inc.

Yale University

A&G Pharmaceutical, Inc., Companion Diagnostic Test-Ovarian Cancer; Abnova Corporation, Biomarker Test-Ovarian Cancer; Almac Diagnostics Limited, Diagnostic Test-Ovarian Cancer; ANGLE plc, Parsortix-Based Test-Ovarian Cancer; AroCell AB, TK 210 Assay-Ovarian Cancer; ArtemixRx, ArtemixRx Prognostic Test-Ovarian Cancer; Augusta University, Biomarker Test-Ovarian Cancer; Aurelium BioPharma Inc., MMD ELISA Test-Ovarian Cancer; Aurelium BioPharma Inc., MMD QPCR Test-Ovarian cancer; Aurelium BioPharma Inc., Ovarian Cancer Screening Test; Avant Diagnostics, Inc., OvaDx; Axela Inc., Multiplex Ovarian Cancer Biomarker Assay; Ayanda Biosystems S.A., Diagnostic Test-Ovarian Cancer; Becton, Dickinson and Company, Diagnostic Test-Ovarian Cancer; Bioindustry Park Silvano Fumero S.p.A., Diagnostic Kit-Ovarian Cancer; Ceres Nanosciences, Inc., Nanotrap Ovarian Cancer Biomarker Test; Chronix Biomedical, Inc., Companion Diagnostic Test-Ovarian Cancer; Clarient, Inc., Ovatax; ClavGen Therapeutics LLC, Prognostic Assay-Ovarian Cancer; Cleveland Diagnostics Inc., Blood-Based Diagnostic Test-Ovarian Cancer; Clovis Oncology, Inc., Rucaparib Companion Diagnostic Test; Courtagen Life Sciences, Inc., Ovarian Cancer Diagnostic Panel; Dako A/S, MK-8109 Companion Diagnostic Test; Dana-Farber Cancer Institute, Inc., Biomarker Assay-Ovarian Carcinoma; Diazyme Laboratories, B7-H4 Assay; Diazyme Laboratories, DcR3 (DD-C248) Assay; Diazyme Laboratories, MIC-1 (DD-X065) Assay; Diazyme Laboratories, Spondin-2 (DD-P108) Assay; Eventus Diagnostics, Inc., Octava Test-Ovarian Cancer; Exiqon A/S, miRNA test-Ovarian Cancer; Exosomics Siena SpA, EXOTEST Ovarian; Fahy Gurteen UK Limited, Diagnostic Test-Ovarian Cancer; Foundation Medicine, Inc., Companion Diagnostic Assay-Rucaparib; French National Institute of Health and Medical Research, PTPL1 Based Prognostic Assay-Ovarian Cancer; Ganymed Pharmaceuticals AG, IMAB027 Companion Diagnostic Test; GeneNews Limited, Biomarker Diagnostic Test-Ovarian Cancer; Georgia Institute of Technology, Mass Spectrometry Based Ovarian Cancer Test; GlycoZym, Diagnostic Assay-Ovarian Cancer; H. Lee Moffitt Cancer Center &; Research Institute, Inc., Diagnostic Assay-Ovarian Cancer; Ikonisys, Inc., oncoFISH ovarian; Inanovate (UK) Ltd., Biomarker Based Test-Ovarian Cancer; InterGenetics Incorporated, OncoVue Ovarian; IV Diagnostics, Inc., Diagnostic Test-Ovarian Cancer; John Hopkins University, Methylation Based Biomarker Assay-Ovarian Cancer; John Hopkins University, Multivariate Index Assay-Ovarian Cancer; John Hopkins University, Protein Biomarker Diagnostic Assay-Ovarian Cancer Chemoresistance; KIYATEC Inc., Ovarian Cancer Dx; Lab Discoveries Ltd., Diagnostic Test-Ovarian Cancer; Laboratorios SALVAT S.A., Diagnostic Kit-Ovarian Cancer; Laboratory Corporation of America Holdings, OvaSure; Louisville Bioscience, Inc., Ovarian Cancer Remission pT Test; MabCure Inc., Diagnostic Test-Ovarian Cancer 1; MDNA Life Sciences, Inc., Ovarian Mitomic Test; MDxHealth SA, PharmacoDx-Ovarian Cancer; Metabolon, Inc., Diagnostic Test-Ovarian Cancer; Milagen, Inc., Immunoassay-Ovarian Cancer; Myriad Genetics, Inc., myChoice HRD (PARP)-Niraparib; Nanosphere, Inc., Ultra-Sensitive Assay-Ovarian Cancer; National University of Singapore, Lipid Biomarker Diagnostic Assay; Novel Bio-spectrum Technologies, Inc., NBT Diagnostic Test-Ovarian Cancer; Olympia Diagnostics, Inc, Prognostic Test-Ovarian Cancer; Oncgnostics GmbH, Oncgnostics Diagnostic Test-Ovarian Cancer; Oncimmune (USA) LLC, EarlyCDT-Ovarian Cancer; Orion Genomics LLC, Diagnostic Test-Ovarian Cancer; Oryzon Genomics SA, Prognostic Assay-Ovarian Cancer; OTraces Inc., Ovarian Cancer Sera Dx; PeriRx LLC, Saliva Test-Ovarian Cancer; Phenomenome Discoveries, Inc., OvAware; Precision Biologics, Inc., Diagnostic Assay-Ovarian Cancer; Pronota NV, Diagnostic Test-Ovarian Cancer; Protagen AG, Diagnostic Assay-Ovarian Cancer; Proteomika, Proteomika Biomarker Test-Ovarian Cancer; Provista Diagnostics Inc., Videssa Ovarian; RiboMed Biotechnologies, Inc., Ovarian Cancer Theranostic Assay; Roche Diagnostics International Ltd., MUC16 ADC Companion Diagnostic Test; Roche Diagnostics International Ltd., NaPi2b ADC Companion Diagnostic Test; Rosetta Genomics Ltd, microRNA Test-Ovarian Cancer; SomaLogic, Inc., SOMAscan Assay-Ovarian Cancer; Soricimed Biopharma Inc., Diagnostic SOR-D01 Assay-Ovarian Cancer; Soricimed Biopharma Inc., Diagnostic SOR-D02 Assay-Ovarian Cancer; Stage I Diagnostics, Inc., O-TAB Test; SurExam Life Science &; Technology Co., Diagnostic Test-Ovarian Cancer; Target Discovery, Inc., Isonostic Assay-Ovarian Cancer; Teva Pharmaceutical Industries Ltd., Diagnostic Assay-Ovarian Cancer; The University of Adelaide, Luminex Assay; The University of Texas MD Anderson Cancer Center, Diagnostic Assay-Ovarian Cancer; Todos Medical, Diagnostic Test-Ovarian Cancer; Transbiomed, SL, Biomarker Diagnostic Test-Ovarian Cancer; Universite de Montreal, Serum Biomarker Test-Ovarian Cancer; University of South Florida, HMGA2 Based Diagnostic Assay-Ovarian Cancer; University of South Florida, Lysophospholipids Biomarker Assay-Ovarian Cancer; US Biomarkers, Inc., Blood-Based Biomarker-Ovarian Cancer; Vermillion, Inc., OvaCheck 2; Vitatex Inc., Diagnostic Test-Ovarian Cancer; Vitatex Inc., Ovarian Cancer CTC Detection Kit; Vitruvian Biomedical, Inc., Diagnostic Assay-Ovarian Cancer; Yale University, Diagnostic Assay-Ovarian Cancer


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