Ovarian Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2017

2017-10-01
Price :
Published : Oct-2017
No. of Pages : 346
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
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 28
5.1 2X Oncology Inc Company Overview 28
5.2 A&G Pharmaceutical Inc Company Overview 29
5.3 Abnova Corp Company Overview 30
5.4 Advanced Marker Discovery SL Company Overview 31
5.5 Almac Diagnostics Ltd Company Overview 32
5.6 ANGLE plc Company Overview 35
5.7 AroCell AB Company Overview 38
5.8 Aurelium BioPharma Inc. Company Overview 39
5.9 Avant Diagnostics, Inc. Company Overview 42
5.10 Axela Inc Company Overview 43
5.11 Ayanda Biosystems SA (Inactive) Company Overview 44
5.12 BARD1 Life Sciences Ltd Company Overview 45
5.13 Becton Dickinson and Co Company Overview 46
5.14 BioFluidica Microtechnologies LLC Company Overview 47
5.15 Bioindustry Park Silvano Fumero SpA Company Overview 48
5.16 Bioprognos SL Company Overview 49
5.17 Celcuity LLC Company Overview 50
5.18 Ceres Nanosciences Inc Company Overview 51
5.19 Chronix Biomedical Inc Company Overview 52
5.20 Clarient Inc Company Overview 53
5.21 ClavGen Therapeutics LLC Company Overview 54
5.22 Cleveland Diagnostics Inc. Company Overview 55
5.23 Courtagen Life Sciences Inc Company Overview 56
5.24 Dana-Farber Cancer Institute Inc Company Overview 57
5.25 Diazyme Laboratories Inc Company Overview 58
5.26 Eventus Diagnostics Inc (Inactive) Company Overview 61
5.27 Exiqon A/S Company Overview 62
5.28 Exosomics Siena SpA Company Overview 63
5.29 Fahy Gurteen UK Ltd Company Overview 64
5.30 French National Institute of Health and Medical Research Company Overview 65
5.31 Fujirebio Diagnostics Inc Company Overview 66
5.32 Ganymed Pharmaceuticals AG Company Overview 67
5.33 GeneNews Ltd Company Overview 68
5.34 Georgia Institute of Technology Company Overview 69
5.35 GlycoZym Company Overview 70
5.36 H. Lee Moffitt Cancer Center & Research Institute Inc Company Overview 71
5.37 Hide and Seq Company Overview 72
5.38 Ikonisys Inc Company Overview 73
5.39 InterGenetics Inc Company Overview 74
5.40 IV Diagnostics Inc Company Overview 75
5.41 John Hopkins University Company Overview 76
5.42 King Abdullah University of Science and Technology Company Overview 79
5.43 KIYATEC Inc Company Overview 80
5.44 Lab Discoveries Ltd Company Overview 81
5.45 Laboratorios SALVAT SA Company Overview 82
5.46 Laboratory Corp of America Holdings Company Overview 83
5.47 Lantern Pharma Inc Company Overview 84
5.48 Louisville Bioscience, Inc. Company Overview 85
5.49 MabCure Inc. Company Overview 86
5.50 Massachusetts Institute of Technology Company Overview 87
5.51 MDNA Life Sciences Inc Company Overview 88
5.52 MDxHealth SA Company Overview 89
5.53 Metabolon Inc Company Overview 90
5.54 Milagen Inc Company Overview 91
5.55 MyCartis NV Company Overview 92
5.56 Myriad Genetics Inc Company Overview 93
5.57 Nanocytomics LLC Company Overview 96
5.58 National University of Singapore Company Overview 97
5.59 NGeneBio Co Ltd Company Overview 98
5.60 Novel Bio-spectrum Technologies Inc (Inactive) Company Overview 99
5.61 Olympia Diagnostics, Inc Company Overview 100
5.62 Oncgnostics GmbH Company Overview 101
5.63 Oncimmune (USA) LLC Company Overview 102
5.64 Orion Genomics LLC Company Overview 103
5.65 Oryzon Genomics SA Company Overview 104
5.66 OTraces Inc. Company Overview 105
5.67 Peregrine Pharmaceuticals, Inc. Company Overview 106
5.68 PeriRx LLC Company Overview 107
5.69 Phenomenome Discoveries Inc Company Overview 108
5.70 Precision Biologics Inc Company Overview 109
5.71 Protagen AG Company Overview 110
5.72 Proteomika Company Overview 111
5.73 Provista Diagnostics Inc Company Overview 112
5.74 Roche Diagnostics International Ltd Company Overview 113
5.75 Rosetta Genomics Ltd Company Overview 115
5.76 SomaLogic Inc Company Overview 116
5.77 Soricimed Biopharma Inc Company Overview 117
5.78 Stage I Diagnostics Inc Company Overview 119
5.79 SurExam Life Science & Technology Co. Company Overview 120
5.80 Target Discovery Inc (Inactive) Company Overview 121
5.81 Teva Pharmaceutical Industries Ltd Company Overview 122
5.82 The University of Adelaide Company Overview 123
5.83 Treos Bio Inc Company Overview 126
5.84 University of Arkansas for Medical Sciences Company Overview 127
5.85 University of California San Diego Company Overview 128
5.86 University of Chicago Company Overview 129
5.87 University of Montreal Company Overview 130
5.88 University of Pittsburgh Company Overview 131
5.89 University of South Florida Company Overview 132
5.90 University of Texas MD Anderson Cancer Center Company Overview 134
5.91 US Biomarkers Inc Company Overview 135
5.92 Vermillion Inc Company Overview 136
5.93 Vitatex Inc. Company Overview 137
5.94 Vitruvian Biomedical Inc Company Overview 139
5.95 Yale University Company Overview 140
6 Ovarian Cancer Diagnostic Tests - Recent Developments 141
6.1 Sep 11, 2017: Teva Names Kare Schultz as President and Chief Executive Officer 141
6.2 Sep 07, 2017: Abbott Named Industry Leader for Responsible and Sustainable Business for Five Consecutive Years on the Dow Jones Sustainability Index 142
6.3 Sep 06, 2017: MDxHealth Prepares for Growth with Executive Team Expansion 143
6.4 Sep 05, 2017: Rosetta Genomics to Reduce Operating and Other Expenses 143
6.5 Sep 04, 2017: Novartis announces CEO Joseph Jimenez to retire from Novartis in 2018. Vasant Narasimhan appointed CEO, effective February 1, 2018. 144
6.6 Aug 31, 2017: MDxHealth Announces First Half 2017 Financial Results 145
6.7 Aug 29, 2017: Todos Medical Appoints Dr. Meir Silver as Vice President of Clinical Research and Regulatory Affairs 147
6.8 Aug 24, 2017: Novartis appoints Bertrand Bodson as Chief Digital Officer 147
6.9 Aug 24, 2017: AroCell: Interim report, Q2 2017 148
6.10 Aug 24, 2017: LabCorp Names Nationally Recognized Health-Policy Expert Dr. Brian Caveney As Enterprise-Wide Chief Medical Officer 150
6.11 Aug 18, 2017: District Court Issues Final Judgment - Retractable Technologies v. Becton, Dickinson 151
6.12 Aug 15, 2017: GeneNews Announces Q2-2017 Financial Results & Provides Progress Update 151
6.13 Aug 07, 2017: MDxHealth Appoints Seasoned EVP to Lead Sales Force Expansion 152
6.14 Aug 03, 2017: BD Announces Results For 2017 Third Fiscal Quarter 153
6.15 Aug 03, 2017: Teva Reports Second Quarter 2017 Financial Results 154
6.16 Aug 02, 2017: Clovis Oncology Announces Second Quarter 2017 Operating Results 157
6.17 Aug 01, 2017: Pfizer Reports Second-Quarter 2017 Results 159
6.18 Aug 01, 2017: Foundation Medicine Announces 2017 Second Quarter Results and Recent Highlights 164
6.19 Jul 28, 2017: ORYZON Reports Financial Results and Corporate Update for the 1st Half Ended June 30, 2017 165
6.20 Jul 27, 2017: Adaptive Biotechnologies Expands Leadership to Bolster Integration of Immune Profiling into Clinical Care Setting 166
6.21 Jul 26, 2017: LabCorp Announces Record Results in the Second Quarter of 2017 and Increases 2017 Guidance 167
6.22 Jul 23, 2017: Teva to Terminate Around 300 jobs in Israel 169
6.23 Jul 20, 2017: Abbott Reports Second-Quarter 2017 Results 170
6.24 Jul 18, 2017: Q2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative products 172
6.25 Jul 18, 2017: LabCorp's William Hanlon Appointed to Governing Committee of the National Evaluation System for health Technology Coordinating Center 177
6.26 Jul 13, 2017: Teva Enhances Board of Directors as All Proposals Approved at Annual General Meeting of Shareholders 178
6.27 Jul 06, 2017: Rosetta Genomics Expands Patent Portfolio in Canada, United States, and China 179
6.28 Jul 04, 2017: ANGLE Reports Successful Headline Data in US and European Ovarian Cancer Studies in 400 Patients 179
7 Appendix 341
7.1 Methodology 341
7.2 About GlobalData 344
7.3 Contact Us 344
7.4 Disclaimer 344

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: 2X Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 30
Table 9: 2X-131 Companion Diagnostic Assay - Product Status 30
Table 10: 2X-131 Companion Diagnostic Assay - Product Description 30
Table 11: A&G Pharmaceutical Inc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 12: Companion Diagnostic Test - Ovarian Cancer - Product Status 31
Table 13: Companion Diagnostic Test - Ovarian Cancer - Product Description 31
Table 14: Abnova Corp Pipeline Products & Ongoing Clinical Trials Overview 32
Table 15: Biomarker Test - Ovarian Cancer - Product Status 32
Table 16: Biomarker Test - Ovarian Cancer - Product Description 32
Table 17: Advanced Marker Discovery SL Pipeline Products & Ongoing Clinical Trials Overview 33
Table 18: Biomarker Diagnostic Test - Ovarian Cancer - Product Status 33
Table 19: Biomarker Diagnostic Test - Ovarian Cancer - Product Description 33
Table 20: Almac Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 34
Table 21: ALM AADx Assay - Product Status 34
Table 22: ALM AADx Assay - Product Description 34
Table 23: Diagnostic Test - Ovarian Cancer - Product Status 35
Table 24: Diagnostic Test - Ovarian Cancer - Product Description 35
Table 25: DNA Damage Response Deficiency Assay - Ovarian Cancer - Product Status 35
Table 26: DNA Damage Response Deficiency Assay - Ovarian Cancer - Product Description 36
Table 27: ANGLE plc Pipeline Products & Ongoing Clinical Trials Overview 37
Table 28: Parsortix-Based Test - Ovarian Cancer - Product Status 37
Table 29: Parsortix-Based Test - Ovarian Cancer - Product Description 37
Table 30: ANGLE plc - Ongoing Clinical Trials Overview 38
Table 31: Parsortix-Based Test - Ovarian Cancer - Evaluation of Multiple Circulating Tumor Cell-derived RNA Markers to Estimate Risk of Ovarian Cancer in Patients Presenting with a Pelvic Mass: ANG-001 Pelvic Mass Training Study 39
Table 32: Parsortix-Based Test - Ovarian Cancer - Evaluation of Multiple Protein and Molecular Biomarkers to Estimate Risk of Cancer in Gynecology Patients Presenting with a Pelvic Mass: ANG-003 EMBER Study 39
Table 33: AroCell AB Pipeline Products & Ongoing Clinical Trials Overview 40
Table 34: TK 210 Assay - Ovarian Cancer - Product Status 40
Table 35: TK 210 Assay - Ovarian Cancer - Product Description 40
Table 36: Aurelium BioPharma Inc. Pipeline Products & Ongoing Clinical Trials Overview 41
Table 37: MMD ELISA Test - Ovarian Cancer - Product Status 41
Table 38: MMD ELISA Test - Ovarian Cancer - Product Description 41
Table 39: MMD QPCR Test - Ovarian cancer - Product Status 42
Table 40: MMD QPCR Test - Ovarian cancer - Product Description 42
Table 41: Ovarian Cancer Screening Test - Product Status 42
Table 42: Ovarian Cancer Screening Test - Product Description 43
Table 43: Avant Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44
Table 44: OvaDx - Product Status 44
Table 45: OvaDx - Product Description 44
Table 46: Axela Inc Pipeline Products & Ongoing Clinical Trials Overview 45
Table 47: Multiplex Ovarian Cancer Biomarker Assay - Product Status 45
Table 48: Multiplex Ovarian Cancer Biomarker Assay - Product Description 45
Table 49: Ayanda Biosystems SA (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 46
Table 50: Diagnostic Test - Ovarian Cancer - Product Status 46
Table 51: Diagnostic Test - Ovarian Cancer - Product Description 46
Table 52: BARD1 Life Sciences Ltd Pipeline Products & Ongoing Clinical Trials Overview 47
Table 53: BARD1 Ovarian Cancer Test - Product Status 47
Table 54: BARD1 Ovarian Cancer Test - Product Description 47
Table 55: Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 48
Table 56: Diagnostic Test - Ovarian Cancer - Product Status 48
Table 57: Diagnostic Test - Ovarian Cancer - Product Description 48
Table 58: BioFluidica Microtechnologies LLC Pipeline Products & Ongoing Clinical Trials Overview 49
Table 59: Circulating Tumor Cells Screening Assay - Ovarian Cancer - Product Status 49
Table 60: Circulating Tumor Cells Screening Assay - Ovarian Cancer - Product Description 49
Table 61: Bioindustry Park Silvano Fumero SpA Pipeline Products & Ongoing Clinical Trials Overview 50
Table 62: Diagnostic Kit - Ovarian Cancer - Product Status 50
Table 63: Diagnostic Kit - Ovarian Cancer - Product Description 50
Table 64: Bioprognos SL Pipeline Products & Ongoing Clinical Trials Overview 51
Table 65: MBDAA Ovarian Cancer Test - Product Status 51
Table 66: MBDAA Ovarian Cancer Test - Product Description 51
Table 67: Celcuity LLC Pipeline Products & Ongoing Clinical Trials Overview 52
Table 68: CELx Test - Ovarian Cancer - Product Status 52
Table 69: CELx Test - Ovarian Cancer - Product Description 52
Table 70: Ceres Nanosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 71: Nanotrap Ovarian Cancer Biomarker Test - Product Status 53
Table 72: Nanotrap Ovarian Cancer Biomarker Test - Product Description 53
Table 73: Chronix Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 54
Table 74: Diagnostic Test - Ovarian Cancer - Product Status 54
Table 75: Diagnostic Test - Ovarian Cancer - Product Description 54
Table 76: Clarient Inc Pipeline Products & Ongoing Clinical Trials Overview 55
Table 77: Ovatax - Product Status 55
Table 78: Ovatax - Product Description 55
Table 79: ClavGen Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 56
Table 80: Prognostic Assay - Ovarian Cancer - Product Status 56
Table 81: Prognostic Assay - Ovarian Cancer - Product Description 56
Table 82: Cleveland Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 57
Table 83: Blood-Based Diagnostic Test - Ovarian Cancer - Product Status 57
Table 84: Blood-Based Diagnostic Test - Ovarian Cancer - Product Description 57
Table 85: Courtagen Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 58
Table 86: Ovarian Cancer Diagnostic Panel - Product Status 58
Table 87: Ovarian Cancer Diagnostic Panel - Product Description 58
Table 88: Dana-Farber Cancer Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 59
Table 89: Biomarker Assay - Ovarian Carcinoma - Product Status 59
Table 90: Biomarker Assay - Ovarian Carcinoma - Product Description 59
Table 91: Diazyme Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 60
Table 92: B7-H4 Assay - Product Status 60
Table 93: B7-H4 Assay - Product Description 60
Table 94: DcR3 (DD-C248) Assay - Product Status 61
Table 95: DcR3 (DD-C248) Assay - Product Description 61
Table 96: MIC-1 (DD-X065) Assay - Product Status 61
Table 97: MIC-1 (DD-X065) Assay - Product Description 62
Table 98: Spondin-2 (DD-P108) Assay - Product Status 62
Table 99: Spondin-2 (DD-P108) Assay - Product Description 62
Table 100: Eventus Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 63
Table 101: Octava Test - Ovarian Cancer - Product Status 63
Table 102: Octava Test - Ovarian Cancer - Product Description 63
Table 103: Exiqon A/S Pipeline Products & Ongoing Clinical Trials Overview 64
Table 104: miRNA test - Ovarian Cancer - Product Status 64
Table 105: miRNA test - Ovarian Cancer - Product Description 64
Table 106: Exosomics Siena SpA Pipeline Products & Ongoing Clinical Trials Overview 65
Table 107: EXOTEST Ovarian - Product Status 65
Table 108: EXOTEST Ovarian - Product Description 65
Table 109: Fahy Gurteen UK Ltd Pipeline Products & Ongoing Clinical Trials Overview 66
Table 110: Diagnostic Test - Ovarian Cancer - Product Status 66
Table 111: Diagnostic Test - Ovarian Cancer - Product Description 66
Table 112: French National Institute of Health and Medical Research Pipeline Products & Ongoing Clinical Trials Overview 67
Table 113: PTPL1 Based Prognostic Assay - Ovarian Cancer - Product Status 67
Table 114: PTPL1 Based Prognostic Assay - Ovarian Cancer - Product Description 67
Table 115: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 68
Table 116: CA125 II Assay - Product Status 68
Table 117: CA125 II Assay - Product Description 68
Table 118: Ganymed Pharmaceuticals AG Pipeline Products & Ongoing Clinical Trials Overview 69
Table 119: IMAB027 Companion Diagnostic Test - Product Status 69
Table 120: IMAB027 Companion Diagnostic Test - Product Description 69
Table 121: GeneNews Ltd Pipeline Products & Ongoing Clinical Trials Overview 70
Table 122: Biomarker Diagnostic Test - Ovarian Cancer - Product Status 70
Table 123: Biomarker Diagnostic Test - Ovarian Cancer - Product Description 70
Table 124: Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 71
Table 125: Mass Spectrometry Based Ovarian Cancer Test - Product Status 71
Table 126: Mass Spectrometry Based Ovarian Cancer Test - Product Description 71
Table 127: GlycoZym Pipeline Products & Ongoing Clinical Trials Overview 72
Table 128: Diagnostic Assay - Ovarian Cancer - Product Status 72
Table 129: Diagnostic Assay - Ovarian Cancer - Product Description 72
Table 130: H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 73
Table 131: Diagnostic Assay - Ovarian Cancer - Product Status 73
Table 132: Diagnostic Assay - Ovarian Cancer - Product Description 73
Table 133: Hide and Seq Pipeline Products & Ongoing Clinical Trials Overview 74
Table 134: Predictive Assay - Ovarian Cancer - Product Status 74
Table 135: Predictive Assay - Ovarian Cancer - Product Description 74
Table 136: Ikonisys Inc Pipeline Products & Ongoing Clinical Trials Overview 75
Table 137: oncoFISH ovarian - Product Status 75
Table 138: oncoFISH ovarian - Product Description 75
Table 139: InterGenetics Inc Pipeline Products & Ongoing Clinical Trials Overview 76
Table 140: OncoVue Ovarian - Product Status 76
Table 141: OncoVue Ovarian - Product Description 76
Table 142: IV Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 77
Table 143: Diagnostic Test - Ovarian Cancer - Product Status 77
Table 144: Diagnostic Test - Ovarian Cancer - Product Description 77
Table 145: John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 78
Table 146: Biomarker Assay - Ovarian Cancer Chemoresistance - Product Status 78
Table 147: Biomarker Assay - Ovarian Cancer Chemoresistance - Product Description 78
Table 148: Methylation Based Biomarker Assay - Ovarian Cancer - Product Status 79
Table 149: Methylation Based Biomarker Assay - Ovarian Cancer - Product Description 79
Table 150: Multivariate Index Assay - Ovarian Cancer - Product Status 79
Table 151: Multivariate Index Assay - Ovarian Cancer - Product Description 80
Table 152: Protein Biomarker Diagnostic Assay - Ovarian Cancer Chemoresistance - Product Status 80
Table 153: Protein Biomarker Diagnostic Assay - Ovarian Cancer Chemoresistance - Product Description 80
Table 154: King Abdullah University of Science and Technology Pipeline Products & Ongoing Clinical Trials Overview 81
Table 155: Diagnostic Test - Ovarian Cancer - Product Status 81
Table 156: Diagnostic Test - Ovarian Cancer - Product Description 81
Table 157: KIYATEC Inc Pipeline Products & Ongoing Clinical Trials Overview 82
Table 158: Ovarian Cancer Dx - Product Status 82
Table 159: Ovarian Cancer Dx - Product Description 82
Table 160: Lab Discoveries Ltd Pipeline Products & Ongoing Clinical Trials Overview 83
Table 161: Diagnostic Test - Ovarian Cancer - Product Status 83
Table 162: Diagnostic Test - Ovarian Cancer - Product Description 83

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
Filed in: In Vitro Diagnostic, Medical Device
Publisher : GlobalData