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Prostate Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2016

Published By :

GlobalData

Published Date : Dec 2016

Category :

Cancer

No. of Pages : 470 Pages

Prostate Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, Prostate Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2016" provides an overview of Prostate 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 Prostate 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 Prostate 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 Prostate 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 Prostate 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 products current stage of development, territory and estimated launch date
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 12
1.2 List of Figures 26
2 Introduction 27
2.1 Prostate Cancer Diagnostic Tests Overview 27
3 Products under Development 28
3.1 Prostate Cancer Diagnostic Tests - Pipeline Products by Stage of Development 28
3.2 Prostate Cancer Diagnostic Tests - Pipeline Products by Territory 29
3.3 Prostate Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 30
3.4 Prostate Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 31
3.5 Prostate Cancer Diagnostic Tests - Ongoing Clinical Trials 32
4 Prostate Cancer Diagnostic Tests - Pipeline Products under Development by Companies 33
4.1 Prostate Cancer Diagnostic Tests Companies - Pipeline Products by Stage of Development 33
4.2 Prostate Cancer Diagnostic Tests - Pipeline Products by Stage of Development 40
5 Prostate Cancer Diagnostic Tests Companies and Product Overview 47
5.1 3D Biomatrix, LLC Company Overview 47
5.2 3D Signatures Inc Company Overview 48
5.3 A&G Pharmaceutical Inc Company Overview 49
5.4 Abbott Diagnostics Company Overview 51
5.5 Abnova Corp Company Overview 52
5.6 AccuTech LLC Company Overview 54
5.7 Acobiom Company Overview 55
5.8 Adaptive Biotechnologies Corp Company Overview 57
5.9 Advanced Marker Discovery SL Company Overview 59
5.10 Affinimark Technologies, Inc. Company Overview 61
5.11 AIT Austrian Institute of Technology GmbH Company Overview 62
5.12 Albert-Ludwigs-Universitat Freiburg Company Overview 63
5.13 Almac Diagnostics Ltd Company Overview 64
5.14 AltheaDx Inc Company Overview 65
5.15 Ambrilia Biopharma Inc Company Overview 66
5.16 Andro Diagnostics Company Overview 67
5.17 Armune BioScience, Inc. Company Overview 68
5.18 Arno Therapeutics Inc Company Overview 69
5.19 AroCell AB Company Overview 71
5.20 Arquer Diagnostics Ltd Company Overview 72
5.21 Arrayit Diagnostics, Inc. Company Overview 73
5.22 Atturos Company Overview 74
5.23 Aurelium BioPharma Inc. Company Overview 75
5.24 Bayer HealthCare AG Company Overview 76
5.25 Baylor College of Medicine Company Overview 78
5.26 Beckman Coulter Inc Company Overview 79
5.27 BioAffinity Technologies, Inc. Company Overview 80
5.28 Biocare Medical LLC Company Overview 81
5.29 Biocrates Life Sciences AG Company Overview 82
5.30 BioMark Diagnostics Inc. Company Overview 83
5.31 bioMerieux S.A. Company Overview 84
5.32 BioRap Technologies Ltd Company Overview 88
5.33 Biosceptre (Aust) Pty Ltd Company Overview 89
5.34 Biotron Ltd Company Overview 90
5.35 Blondin Bioscience, LLC Company Overview 92
5.36 Caldera Health Limited Company Overview 93
5.37 Cancer Genetics Inc Company Overview 94
5.38 Cancer Research Technology Ltd Company Overview 96
5.39 Caprion Biosciences Inc Company Overview 97
5.40 Caris Life Sciences Inc Company Overview 98
5.41 Cellanyx Diagnostics, Inc. Company Overview 99
5.42 CellMax Life Company Overview 102
5.43 Cellmid Ltd Company Overview 103
5.44 Cepheid Company Overview 105
5.45 Ceres Nanosciences Inc Company Overview 107
5.46 ChemImage Corporation Company Overview 109
5.47 Children's Hospital Boston Company Overview 110
5.48 China Sky One Medical Inc Company Overview 111
5.49 Chronix Biomedical Inc Company Overview 112
5.50 Cleveland Diagnostics Inc. Company Overview 113
5.51 CompanDX Ltd. Company Overview 116
5.52 Courtagen Life Sciences Inc Company Overview 117
5.53 CS-Keys, Inc. Company Overview 118
5.54 Cytosystems Ltd Company Overview 119
5.55 Detroit R&D, Inc. Company Overview 120
5.56 DiagnoCure Inc. (Inactive) Company Overview 121
5.57 Diaxonhit SA Company Overview 123
5.58 Egenix, Inc. (Inactive) Company Overview 125
5.59 Epic Sciences Inc Company Overview 126
5.60 Epigenomics AG Company Overview 128
5.61 Euclid Diagnostics LLC Company Overview 131
5.62 Eventus Diagnostics Inc (Inactive) Company Overview 132
5.63 Exiqon A/S Company Overview 133
5.64 Exosomics Siena SpA Company Overview 136
5.65 Fluxion Biosciences, Inc. Company Overview 137
5.66 French National Institute of Health and Medical Research Company Overview 139
5.67 Genomic Health Inc Company Overview 140
5.68 Georg-August-Universitat Gottingen Company Overview 142
5.69 Georgia Institute of Technology Company Overview 143
5.70 GILUPI Nanomedizin Company Overview 144
5.71 GlycoZym Company Overview 145
5.72 Hologic Inc Company Overview 146
5.73 Ikonisys Inc Company Overview 148
5.74 Imperial College London Company Overview 149
5.75 Inanovate (UK) Ltd. Company Overview 150
5.76 InterGenetics Inc Company Overview 151
5.77 Inverness Medical Canada Inc. (Inactive) Company Overview 152
5.78 IRIS International, Inc. Company Overview 153
5.79 IV Diagnostics, Inc. Company Overview 154
5.80 Janssen Biotech Inc Company Overview 155
5.81 John Hopkins University Company Overview 156
5.82 KineMed Inc Company Overview 162
5.83 MabCure Inc. Company Overview 163
5.84 MacroArray Technologies LLC Company Overview 165
5.85 Mayo Clinic US Company Overview 168
5.86 MDNA Life Sciences Inc Company Overview 169
5.87 MDxHealth SA Company Overview 172
5.88 Metabolomic Technologies Inc Company Overview 174
5.89 Metamark Genetics, Inc. Company Overview 175
5.90 Metanomics Health GmbH Company Overview 176
5.91 MetaStat Inc Company Overview 177
5.92 Micromedic Technologies Ltd Company Overview 179
5.93 Milagen, Inc. Company Overview 180
5.94 Minomic International Ltd Company Overview 181
5.95 Miraculins Inc Company Overview 182
5.96 Myriad Genetics Inc Company Overview 184
5.97 Nano Discovery Inc. Company Overview 186
5.98 NanoIVD Inc (Inactive) Company Overview 188
5.99 NeuroBioTex Inc. Company Overview 189
5.100 Northwestern University Company Overview 190
5.101 Novel Bio-spectrum Technologies, Inc. Company Overview 191
5.102 Nuclea Biotechnologies Inc. (Inactive) Company Overview 192
5.103 Numares GmbH Company Overview 194
5.104 NuView Life Sciences Inc Company Overview 195
5.105 Olympia Diagnostics, Inc Company Overview 198
5.106 Oncascan Limited Company Overview 202
5.107 Onconome, Inc. (Inactive) Company Overview 203
5.108 ONCOVEDA Cancer Research Center Company Overview 205
5.109 OncoVista Innovative Therapies Inc Company Overview 206
5.110 On-Q-ity, Inc. (Inactive) Company Overview 208
5.111 Ontario Institute for Cancer Research Company Overview 209
5.112 OPKO Health Inc Company Overview 210
5.113 Orion Genomics LLC Company Overview 212
5.114 Ortho-Clinical Diagnostics Inc Company Overview 213
5.115 Oryzon Genomics SA Company Overview 214
5.116 OTraces Inc. Company Overview 216
5.117 Panacea Pharmaceuticals Inc Company Overview 217
5.118 PharmaSeq, Inc. Company Overview 218
5.119 Precision Biologics Inc Company Overview 219
5.120 Predictive Biosciences Inc Company Overview 220
5.121 PrognosDx Health Inc Company Overview 222
5.122 Prostate Management Diagnostics, Inc Company Overview 223
5.123 Protagen AG Company Overview 225
5.124 Proteocyte Diagnostics Inc Company Overview 226
5.125 ProteoMediX AG Company Overview 227
5.126 Proteomika Company Overview 230
5.127 Proveri Inc. (Inactive) Company Overview 231
5.128 Qiagen NV Company Overview 234
5.129 Quanterix Corp Company Overview 236
5.130 RiboMed Biotechnologies Inc Company Overview 238
5.131 Roche Diagnostics International Ltd Company Overview 239
5.132 Roswell Park Cancer Institute Company Overview 241
5.133 Siamab Therapeutics Inc Company Overview 242
5.134 Siemens Healthcare GmbH Company Overview 243
5.135 Sienna Cancer Diagnostics Ltd Company Overview 245
5.136 Sividon Diagnostics GmbH Company Overview 246
5.137 Soricimed Biopharma Inc Company Overview 247
5.138 Source MDx Company Overview 249
5.139 Stage I Diagnostics, Inc. Company Overview 251
5.140 Target Discovery, Inc. Company Overview 252
5.141 The University of South Australia Company Overview 253
5.142 Transbiomed, SL Company Overview 254
5.143 Tyrian Diagnostics Ltd Company Overview 257
5.144 University of California Los Angeles Company Overview 258
5.145 University of Central Florida Company Overview 260
5.146 University of Chicago Company Overview 261
5.147 University of Colorado Company Overview 262
5.148 University of Connecticut Company Overview 263
5.149 University of Iowa Company Overview 264
5.150 University of Maryland, Baltimore Company Overview 265
5.151 University of Michigan Company Overview 266
5.152 University of Oslo Company Overview 267
5.153 University of Otago Company Overview 268
5.154 University of South Florida Company Overview 269
5.155 University of Strathclyde Company Overview 270
5.156 Uppsala University Company Overview 271
5.157 US Biomarkers Inc Company Overview 272
5.158 Vermillion Inc Company Overview 273
5.159 Vitatex Inc. Company Overview 275
5.160 Vitrimark, Inc. Company Overview 276
5.161 Vitruvian Biomedical, Inc. Company Overview 277
5.162 VolitionRX Ltd Company Overview 278
5.163 Yale University Company Overview 282
5.164 ZEUS Scientific Inc Company Overview 283
6 Prostate Cancer Diagnostic Tests - Recent Developments 284
6.1 Nov 22, 2016: OGT announces commercial and financial highlights for FY 2016 284
6.2 Nov 17, 2016: AroCell: Interim report, 1 January 30 September 2016 284
6.3 Nov 17, 2016: AroCell: Interim report January - September 2016 286
6.4 Nov 14, 2016: Vermillion appoints chief medical officer 286
6.5 Nov 14, 2016: Arno Therapeutics Reports Third Quarter 2016 Financial and Business Update 287
6.6 Nov 11, 2016: GeneNews Announces Q3-2016 Financial Results and Provides Corporate Update 288
6.7 Nov 10, 2016: Cancer Genetics Announces Strong Third Quarter with 68% Year over Year Revenue Growth and Highlights Path to Future Profitability 289
6.8 Nov 10, 2016: Vermillion Reports Third Quarter 2016 Results 291
6.9 Nov 10, 2016: VolitionRx Announces Third Quarter 2016 Financial Results and Business Update 292
6.10 Nov 09, 2016: Epigenomics Announces 2016 Third Quarter and Nine Months Financial Results and Reports on Operational Highlights 293
6.11 Nov 09, 2016: Biocept Reports 2016 Third Quarter Financial Results 294
6.12 Nov 08, 2016: Aeterna Zentaris Reports Third Quarter 2016 Financial and Operating Results 296
6.13 Nov 07, 2016: OPKO Health Reports Third Quarter Financial and Operating Results 297
6.14 Nov 07, 2016: Gene Signature Predicts Response to Radiation Therapy 298
6.15 Nov 03, 2016: Geron Reports Third Quarter 2016 Financial Results and Recent Events 299
6.16 Nov 03, 2016: Ann Hammarstrand Appointed as New CFO to AroCell 300
6.17 Nov 02, 2016: MDxHealth Raises USD22.4 Million in Private Placement of Shares 300
6.18 Nov 02, 2016: MDxHealth Provides Third Quarter 2016 Business Update 301
6.19 Nov 02, 2016: QIAGEN Reports Results for Third Quarter and First Nine Months of 2016 302
6.20 Nov 02, 2016: Hologic Announces Financial Results for Fourth Quarter of Fiscal 2016 305
6.21 Nov 01, 2016: Genomic Health Reports Third Consecutive Quarter of Double-Digit Revenue Growth in Announcement of Third Quarter 2016 Financial Results 306
6.22 Nov 01, 2016: Myriad Genetics Reports Fiscal First-Quarter 2017 Financial Results 308
6.23 Oct 31, 2016: MDxHealth Announces Unique CPT Code Awarded for ConfirmMDx from the American Medical Association 309
6.24 Oct 27, 2016: MDxHealth Announces Positive Coverage Policy with Fourth-Largest Health Insurer in the United States 310
6.25 Oct 27, 2016: Biocept Appoints David Moskowitz Vice President, Strategy & Corporate Communications 310
6.26 Oct 26, 2016: DiaCarta Enters into Agreement with National Cancer Institute 311
6.27 Oct 26, 2016: NeoGenomics Reports 142% Revenue Growth to $60.8 Million and a Record $9.6 Million in Cash Flow from Operations in the Third Quarter of 2016 311
6.28 Oct 26, 2016: Ipsen Reports 12.2%1 Sales Growth for the Third Quarter of 2016 and Raises Full Year Guidance 312
6.29 Oct 24, 2016: ORYZON Reports Financial Results and Corporate Update for the 3rd Quarter Ended September 30, 2016 313
6.30 Oct 24, 2016: AltheaDx Announces Appointment of Chief Financial Officer 314
6.31 Oct 21, 2016: Immunodiagnostic Systems Holdings: H1 Trading Update 315
6.32 Oct 20, 2016: Oncolys BioPharma Enters into Research Agreement with DNA Chip Research 316
6.33 Oct 20, 2016: bioMerieux-Business Review for the nine months ended September 30, 2016 316
6.34 Oct 20, 2016: Quest Diagnostics Reports Third Quarter 2016 Financial Results 318
6.35 Oct 19, 2016: 3D Signatures Included in Major Clinical Trial for Prostate Cancer 320
6.36 Oct 19, 2016: MDxHealth Announces Agreement with HIFU CLINIC Prostate Cancer Center for Distribution of SelectMDx in Poland 321
6.37 Oct 19, 2016: MdxHealth Enters into Distributon Agreement with HIFU CLINIC Prostate Cancer Center 321
6.38 Oct 18, 2016: Biomerica Announces First Quarter Fiscal 2017 Financial Results, Sales Increase Over Prior Year 322
6.39 Oct 18, 2016: Johnson & Johnson Reports 2016 Third-Quarter Results 322
6.40 Oct 14, 2016: Biocept Raises USD10 Million in Public Offering of Shares and Warrants 324
6.41 Oct 06, 2016: MDxHealth Reports Highmark Blue Cross Blue Shield Issues Positive Medical Policy On ConfirmMDx 324
6.42 Oct 04, 2016: MDxHealth Announces Agreement with SouthGenetics for Distribution of SelectMDx in Central/South America 325
6.43 Oct 04, 2016: Bostwick Labs Enters into Agreement with GenomeDx Biosciences 325
6.44 Sep 29, 2016: VolitionRX Completes Underwriters Exercise of Over-Allotment of Public Offering of Shares 325
6.45 Sep 29, 2016: Myriad Appoints Chip Parkinson as EVP for Reimbursement Strategy 326
6.46 Sep 28, 2016: MDxHealth and The European Health Centre Innovation Sign Distribution Agreement for SelectMDx in Poland 326
6.47 Sep 28, 2016: MDxHealth and The European Health Centre Innovation Sign Distribution Agreement for ConfirmMDx in Poland 327
6.48 Sep 28, 2016: MDxHealth Enters into Distribution Agreement with European Health Centre Innovation 327
6.49 Sep 28, 2016: GenomeDx Biosciences Enters into Distribution Agreement with SouthGenetics 328
6.50 Sep 27, 2016: MDxHealth Announces Independence Blue Cross Rendered Positive Medical Coverage Policy for ConfirmMDx 328
6.51 Sep 26, 2016: Radiation Therapy and Radical Prostatectomy Further Explored for Initial Diagnosis of Advanced Prostate Cancer 329
6.52 Sep 22, 2016: GenomeDx's Decipher GRID and Decipher Tests to be Featured in Multiple Presentations at ASTRO 2016 329
6.53 Sep 22, 2016: MDxHealth Announces Upgraded Revenue Forecast 332
6.54 Sep 19, 2016: Stage I Diagnostics Raises Funds in Venture Financing 332
6.55 Sep 13, 2016: OPKO Health Appoints Jane Pine Wood as Chief Legal and Compliance Officer of BioReference Laboratories 332
6.56 Sep 09, 2016: Cancer Genetics to Raise USD5.5 Million in Private Placement of Shares and Warrants 333
6.57 Sep 09, 2016: Biocept to Collaborate with Renowned Clinical Investigator Dr. Shilpa Gupta to Study the Utility of Liquid Biopsy Testing in Bladder and Prostate Cancers 333
6.58 Sep 08, 2016: AltheaDx Raises USD6 Million in Venture Financing 333
6.59 Sep 08, 2016: Blue Earth Diagnostics Announces Axumin (Fluciclovine F 18) Presentations at Upcoming Scientific Conferences 333
6.60 Sep 07, 2016: Exosome Diagnostics Announces Launch of ExoDx Prostate(IntelliScore), a Completely Non-Invasive Liquid Biopsy Test to Help Rule Out High-Grade Prostate Cancer 335
6.61 Sep 07, 2016: Armune BioScience Raises USD5 Million in Series A Venture Financing 336
6.62 Sep 06, 2016: MDxHealth Gains Medi-Cal Approval for ConfirmMDx 336
6.63 Sep 02, 2016: Danaher Acquires Cepheid 337
7 Appendix 463
7.1 Methodology 463
7.2 About GlobalData 465
7.3 Contact Us 465
7.4 Disclaimer 466

1.1 List of Tables
Table 1: Prostate Cancer Diagnostic Tests - Pipeline Products by Stage of Development 32
Table 2: Prostate Cancer Diagnostic Tests - Pipeline Products by Territory 33
Table 3: Prostate Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 34
Table 4: Prostate Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 35
Table 5: Prostate Cancer Diagnostic Tests - Ongoing Clinical Trials 36
Table 6: Prostate Cancer Diagnostic Tests Companies - Pipeline Products by Stage of Development 37
Table 7: Prostate Cancer Diagnostic Tests - Pipeline Products by Stage of Development 44
Table 8: 3D Biomatrix, LLC Pipeline Products & Ongoing Clinical Trials Overview 51
Table 9: 3D Cell Assay - Metastatic Prostate Cancer - Product Status 51
Table 10: 3D Cell Assay - Metastatic Prostate Cancer - Product Description 51
Table 11: 3D Signatures Inc Pipeline Products & Ongoing Clinical Trials Overview 52
Table 12: Blood-Based Diagnostic Test - Prostate Cancer - Product Status 52
Table 13: Blood-Based Diagnostic Test - Prostate Cancer - Product Description 52
Table 14: A&G Pharmaceutical Inc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 15: Companion Diagnostic Test - Prostate Cancer - Product Status 53
Table 16: Companion Diagnostic Test - Prostate Cancer - Product Description 54
Table 17: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 55
Table 18: ERG Companion Diagnostic Assay - Product Status 55
Table 19: ERG Companion Diagnostic Assay - Product Description 55
Table 20: Abnova Corp Pipeline Products & Ongoing Clinical Trials Overview 56
Table 21: Biomarker Test - Prostate Cancer - Product Status 56
Table 22: Biomarker Test - Prostate Cancer - Product Description 57
Table 23: AccuTech LLC Pipeline Products & Ongoing Clinical Trials Overview 58
Table 24: PSA Test - Product Status 58
Table 25: PSA Test - Product Description 58
Table 26: Acobiom Pipeline Products & Ongoing Clinical Trials Overview 59
Table 27: Companion Diagnostic Assay - Prostate Cancer - Product Status 59
Table 28: Companion Diagnostic Assay - Prostate Cancer - Product Description 60
Table 29: Diagnostic Assay - Prostate Cancer - Product Status 60
Table 30: Diagnostic Assay - Prostate Cancer - Product Description 60
Table 31: Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 61
Table 32: Ipilimumab Based Companion Diagnostic Test - Product Status 61
Table 33: Ipilimumab Based Companion Diagnostic Test - Product Description 62
Table 34: Advanced Marker Discovery SL Pipeline Products & Ongoing Clinical Trials Overview 63
Table 35: Prognostic Test - Prostate Cancer - Product Status 63
Table 36: Prognostic Test - Prostate Cancer - Product Description 63
Table 37: Urine Based Diagnostic Test - Prostate Cancer - Product Status 64
Table 38: Urine Based Diagnostic Test - Prostate Cancer - Product Description 64
Table 39: Affinimark Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 65
Table 40: Prostalent Diagnostic Test - Product Status 65
Table 41: Prostalent Diagnostic Test - Product Description 65
Table 42: AIT Austrian Institute of Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 66
Table 43: Biomarker Assay - Prostate Cancer - Product Status 66
Table 44: Biomarker Assay - Prostate Cancer - Product Description 66
Table 45: Albert-Ludwigs-Universitat Freiburg Pipeline Products & Ongoing Clinical Trials Overview 67
Table 46: Urine Based Non-Invasive Prostate Cancer Assay - Product Status 67
Table 47: Urine Based Non-Invasive Prostate Cancer Assay - Product Description 67
Table 48: Almac Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 68
Table 49: Prognostic Test - Metastatic Prostate Cancer - Product Status 68
Table 50: Prognostic Test - Metastatic Prostate Cancer - Product Description 68
Table 51: AltheaDx Inc Pipeline Products & Ongoing Clinical Trials Overview 69
Table 52: Prognostic Assay - Prostate Cancer - Product Status 69
Table 53: Prognostic Assay - Prostate Cancer - Product Description 69
Table 54: Ambrilia Biopharma Inc Pipeline Products & Ongoing Clinical Trials Overview 70
Table 55: PSP94 Immunoassay - Product Status 70
Table 56: PSP94 Immunoassay - Product Description 70
Table 57: Andro Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 71
Table 58: Diagnostic Test - Prostate Cancer - Product Status 71
Table 59: Diagnostic Test - Prostate Cancer - Product Description 71
Table 60: Armune BioScience, Inc. Pipeline Products & Ongoing Clinical Trials Overview 72
Table 61: Diagnostic Test - Prostate Cancer - Product Status 72
Table 62: Diagnostic Test - Prostate Cancer - Product Description 72
Table 63: Arno Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 73
Table 64: Onapristone Companion Diagnostic Assay - Prostate Cancer - Product Status 73
Table 65: Onapristone Companion Diagnostic Assay - Prostate Cancer - Product Description 74
Table 66: AroCell AB Pipeline Products & Ongoing Clinical Trials Overview 75
Table 67: TK 210 Assay - Prostate Cancer - Product Status 75
Table 68: TK 210 Assay - Prostate Cancer - Product Description 75
Table 69: Arquer Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 76
Table 70: UroSens Mcm5-ELISA Diagnostic Test - Prostate Cancer - Product Status 76
Table 71: UroSens Mcm5-ELISA Diagnostic Test - Prostate Cancer - Product Description 76
Table 72: Arrayit Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 77
Table 73: Microarray-Based Diagnostic Test - Prostate Cancer - Product Status 77
Table 74: Microarray-Based Diagnostic Test - Prostate Cancer - Product Description 77
Table 75: Atturos Pipeline Products & Ongoing Clinical Trials Overview 78
Table 76: OCProDx - Product Status 78
Table 77: OCProDx - Product Description 78
Table 78: Aurelium BioPharma Inc. Pipeline Products & Ongoing Clinical Trials Overview 79
Table 79: Prostate Cancer Screening Test - Product Status 79
Table 80: Prostate Cancer Screening Test - Product Description 79
Table 81: Bayer HealthCare AG Pipeline Products & Ongoing Clinical Trials Overview 80
Table 82: ODM-201 Based Companion Diagnostic Assay - Product Status 80
Table 83: ODM-201 Based Companion Diagnostic Assay - Product Description 81
Table 84: PSMA BiTE Antibody Based Companion Diagnostic Assay - Product Status 81
Table 85: PSMA BiTE Antibody Based Companion Diagnostic Assay - Product Description 81
Table 86: Baylor College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 82
Table 87: Diagnostic Assay - Prostate Cancer - Product Status 82
Table 88: Diagnostic Assay - Prostate Cancer - Product Description 82
Table 89: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 83
Table 90: UniCel DxC 600i Synchron Access BPH-A Assay - Product Status 83
Table 91: UniCel DxC 600i Synchron Access BPH-A Assay - Product Description 83
Table 92: BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 84
Table 93: CyPath Diagnostic Assay - Prostate Cancer - Product Status 84
Table 94: CyPath Diagnostic Assay - Prostate Cancer - Product Description 84
Table 95: Biocare Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 85
Table 96: Clear View - Prostate Cancer - Product Status 85
Table 97: Clear View - Prostate Cancer - Product Description 85
Table 98: Biocrates Life Sciences AG Pipeline Products & Ongoing Clinical Trials Overview 86
Table 99: Metabolomic Biomarker Assay - Prostate Cancer - Product Status 86
Table 100: Metabolomic Biomarker Assay - Prostate Cancer - Product Description 86
Table 101: BioMark Diagnostics Inc. Pipeline Products & Ongoing Clinical Trials Overview 87
Table 102: Metabolomics-based Diagnostic Assay - Prostate Cancer - Product Status 87
Table 103: Metabolomics-based Diagnostic Assay - Prostate Cancer - Product Description 87
Table 104: bioMerieux S.A. Pipeline Products & Ongoing Clinical Trials Overview 88
Table 105: Annexin A3 Prostate Cancer Marker - Product Status 88
Table 106: Annexin A3 Prostate Cancer Marker - Product Description 89
Table 107: Companion Diagnostic Test - Hormone-Dependent Prostate Cancer - Product Status 89
Table 108: Companion Diagnostic Test - Hormone-Dependent Prostate Cancer - Product Description 89
Table 109: Diagnostic Assay - Prostate Cancer - Product Status 90
Table 110: Diagnostic Assay - Prostate Cancer - Product Description 90
Table 111: Screening Biomarker Assay - Prostate Cancer - Product Status 90
Table 112: Screening Biomarker Assay - Prostate Cancer - Product Description 91
Table 113: BioRap Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 92
Table 114: Biomarker Test - Prostate Cancer - Product Status 92
Table 115: Biomarker Test - Prostate Cancer - Product Description 92
Table 116: Biosceptre (Aust) Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 93
Table 117: Prostate Cancer IHC Diagnostic Test - Product Status 93
Table 118: Prostate Cancer IHC Diagnostic Test - Product Description 93
Table 119: Biotron Ltd Pipeline Products & Ongoing Clinical Trials Overview 94
Table 120: C-Test - Prostrate Cancer - Product Status 94
Table 121: C-Test - Prostrate Cancer - Product Description 95
Table 122: Blondin Bioscience, LLC Pipeline Products & Ongoing Clinical Trials Overview 96
Table 123: FACT Assay - Product Status 96
Table 124: FACT Assay - Product Description 96
Table 125: Caldera Health Limited Pipeline Products & Ongoing Clinical Trials Overview 97
Table 126: ProscaNZ - Product Status 97
Table 127: ProscaNZ - Product Description 97
Table 128: Cancer Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 98
Table 129: Next-Gen DNA Sequencing Assay - Prostate Cancer - Product Status 98
Table 130: Next-Gen DNA Sequencing Assay - Prostate Cancer - Product Description 99
Table 131: Cancer Research Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 100
Table 132: IHC Based Test - Prostate Cancer - Product Status 100
Table 133: IHC Based Test - Prostate Cancer - Product Description 100
Table 134: Caprion Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 101
Table 135: Diagnostic Assay - Prostate Cancer - Product Status 101
Table 136: Diagnostic Assay - Prostate Cancer - Product Description 101
Table 137: Caris Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 102
Table 138: Diagnostic Test - PSA - Product Status 102
Table 139: Diagnostic Test - PSA - Product Description 102
Table 140: Cellanyx Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 103
Table 141: Cellanyx Test - Prostate Cancer - Product Status 103
Table 142: Cellanyx Test - Prostate Cancer - Product Description 103
Table 143: Cellanyx Diagnostics, Inc. - Ongoing Clinical Trials Overview 104
Table 144: Cellanyx Test - Prostate Cancer - A Novel Live Cell Microfluidic Diagnostic Using Phenotypic Biomarkers with Objective Algorithmic Analysis for Prostate Cancer Risk Stratification 105
Table 145: CellMax Life Pipeline Products & Ongoing Clinical Trials Overview 106
Table 146: Cellmax Protect - Prostate Cancer - Product Status 106
Table 147: Cellmax Protect - Prostate Cancer - Product Description 106
Table 148: Cellmid Ltd Pipeline Products & Ongoing Clinical Trials Overview 107
Table 149: MK-ELISA Assay - Prostate Cancer - Product Status 107
Table 150: MK-ELISA Assay - Prostate Cancer - Product Description 108
Table 151: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 109
Table 152: Xpert Prostate CA Early Detection Test - Product Status 109
Table 153: Xpert Prostate CA Early Detection Test - Product Description 110
Table 154: Xpert Prostate Cancer Recurrence Risk Test - Product Status 110
Table 155: Xpert Prostate Cancer Recurrence Risk Test - Product Description 110
Table 156: Ceres Nanosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 111

1.2 List of Figures
Figure 1: Prostate Cancer Diagnostic Tests - Pipeline Products by Stage of Development 32
Figure 2: Prostate Cancer Diagnostic Tests - Pipeline Products by Territory 33
Figure 3: Prostate Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 34
Figure 4: Prostate Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 35
Figure 5: Prostate Cancer Diagnostic Tests - Ongoing Clinical Trials 36

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