Leukemia Diagnostic Tests-Medical Devices Pipeline Assessment, 2017

Leukemia Diagnostic Tests-Medical Devices Pipeline Assessment, 2017


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Executive Summary

Leukemia Diagnostic Tests-Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, "Leukemia Diagnostic Tests-Medical Devices Pipeline Assessment, 2017" provides an overview of Leukemia 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 Leukemia 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 Leukemia 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 Leukemia 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 Leukemia 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



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Ankur Gupta, Head Marketing & Communications

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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 8

2 Introduction 9

2.1 Leukemia Diagnostic Tests Overview 9

3 Products under Development 10

3.1 Leukemia Diagnostic Tests-Pipeline Products by Stage of Development 10

3.2 Leukemia Diagnostic Tests-Pipeline Products by Territory 11

3.3 Leukemia Diagnostic Tests-Pipeline Products by Regulatory Path 12

3.4 Leukemia Diagnostic Tests-Pipeline Products by Estimated Approval Date 13

4 Leukemia Diagnostic Tests-Pipeline Products under Development by Companies 14

4.1 Leukemia Diagnostic Tests Companies-Pipeline Products by Stage of Development 14

4.2 Leukemia Diagnostic Tests-Pipeline Products by Stage of Development 16

5 Leukemia Diagnostic Tests Companies and Product Overview 18

5.1 Acobiom Company Overview 18

5.1.1 Acobiom Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Aegis Sciences Corp Company Overview 19

5.2.1 Aegis Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 19

5.3 BioSense Technologies, Inc. Company Overview 20

5.3.1 BioSense Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

5.4 Cancer Genetics Inc Company Overview 21

5.4.1 Cancer Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.5 Cell2in Company Overview 22

5.5.1 Cell2in Pipeline Products & Ongoing Clinical Trials Overview 22

5.6 CeMines, Inc. (Inactive) Company Overview 23

5.6.1 CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23

5.7 Cepheid Company Overview 24

5.7.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 24

5.8 Di.V.A.L Toscana srl Company Overview 25

5.8.1 Di.V.A.L Toscana srl Pipeline Products & Ongoing Clinical Trials Overview 25

5.9 DiaSorin S.p.A Company Overview 26

5.9.1 DiaSorin S.p.A Pipeline Products & Ongoing Clinical Trials Overview 26

5.10 Eutropics Pharmaceuticals Inc Company Overview 32

5.10.1 Eutropics Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.11 H. Lee Moffitt Cancer Center & Research Institute Inc Company Overview 36

5.11.1 H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.12 Health Discovery Corp Company Overview 37

5.12.1 Health Discovery Corp Pipeline Products & Ongoing Clinical Trials Overview 37

5.13 IV Diagnostics, Inc. Company Overview 38

5.13.1 IV Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

5.14 Jaden BioScience Inc. Company Overview 39

5.14.1 Jaden BioScience Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

5.15 King's College London Company Overview 40

5.15.1 King's College London Pipeline Products & Ongoing Clinical Trials Overview 40

5.16 Microfluidic Innovations LLC Company Overview 41

5.16.1 Microfluidic Innovations LLC Pipeline Products & Ongoing Clinical Trials Overview 41

5.17 Monoquant Pty. Ltd. Company Overview 42

5.17.1 Monoquant Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 42

5.18 Nodality Inc Company Overview 43

5.18.1 Nodality Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.19 NuCana BioMed Ltd Company Overview 44

5.19.1 NuCana BioMed Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

5.20 Nuclea Biotechnologies Inc. (Inactive) Company Overview 49

5.20.1 Nuclea Biotechnologies Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49

5.21 OncoVista Innovative Therapies Inc Company Overview 51

5.21.1 OncoVista Innovative Therapies Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.22 Roche Diagnostics International Ltd Company Overview 52

5.22.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

5.23 Siemens Healthcare GmbH Company Overview 53

5.23.1 Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 53

5.24 SkylineDx BV Company Overview 54

5.24.1 SkylineDx BV Pipeline Products & Ongoing Clinical Trials Overview 54

5.25 St. Jude Children's Research Hospital Inc Company Overview 55

5.25.1 St. Jude Children's Research Hospital Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.26 Stanford University Company Overview 57

5.26.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 57

5.27 The Feinstein Institute for Medical Research Company Overview 58

5.27.1 The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 58

5.28 Treos Bio Inc Company Overview 59

5.28.1 Treos Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.29 University of Bergen Company Overview 60

5.29.1 University of Bergen Pipeline Products & Ongoing Clinical Trials Overview 60

5.30 University of California San Diego Company Overview 61

5.30.1 University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 61

5.31 University of Colorado Company Overview 63

5.31.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 63

5.32 University of Missouri Company Overview 64

5.32.1 University of Missouri Pipeline Products & Ongoing Clinical Trials Overview 64

5.33 University of Pennsylvania Company Overview 65

5.33.1 University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview 65

5.34 Vela Diagnostics Pte. Ltd Company Overview 66

5.34.1 Vela Diagnostics Pte. Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

5.35 Vivia Biotech SL Company Overview 67

5.35.1 Vivia Biotech SL Pipeline Products & Ongoing Clinical Trials Overview 67

5.36 Wake Forest Baptist Medical Center Company Overview 69

5.36.1 Wake Forest Baptist Medical Center Pipeline Products & Ongoing Clinical Trials Overview 69

6 Leukemia Diagnostic Tests-Recent Developments 70

6.1 Jun 06, 2017: BD Releases 2016 Sustainability Report 70

6.2 Jun 01, 2017: MolecularMD achieves status as an ArcherDX Certified Service Provider and expands offering of novel NGS chemistries 70

6.3 May 08, 2017: Dr. Stephen S. Lane joins Alcon as Chief Medical Officer and Global Head Franchise Clinical Strategy 71

6.4 May 02, 2017: BD Announces Results For 2017 Second Fiscal Quarter 71

6.5 May 02, 2017: Pfizer Reports First-Quarter 2017 Results 73

6.6 May 02, 2017: QIAGEN reports results for first quarter 2017 78

6.7 Apr 26, 2017: NeoGenomics Reports 15% Volume Growth and 10% Reduction in Average Cost per Test in the First Quarter of 2017 80

6.8 Apr 25, 2017: Novartis delivered sales growth across all divisions as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued 82

6.9 Apr 25, 2017: Laboratory Corporation of America Holdings Announces 2017 First Quarter Results and Updates 2017 Guidance 86

6.10 Apr 23, 2017: BD Announces Appointment Of Tom Polen As President 88

6.11 Apr 21, 2017: Covance to Expand Large-Molecule Development Capabilities in the UK 89

6.12 Apr 20, 2017: NeoGenomics Appoints Bill Bonello as Vice President, Treasurer, and Director of Corporate Development 89

6.13 Apr 17, 2017: Dr. Frank Basile Joins Aegis Sciences as Chief Executive Officer 90

6.14 Mar 29, 2017: LabCorp Promotes Executive Gary Huff to CEO of LabCorp Diagnostics, One of the Company's Two Primary Business Segments 90

6.15 Mar 28, 2017: BD Announces Success of Helping Build Healthy Communities Program, Launches New Effort Focused on Medication Therapy Management 91

6.16 Mar 23, 2017: Cancer Genetics Announces Record Revenue for Fourth Quarter and Full-Year 2016 and Provides 2017 Business Update 92

6.17 Mar 21, 2017: Retractable Technologies Announces Litigation Updates 93

6.18 Mar 13, 2017: Cancer Genetics to Present at A Future Without Cancer Conference on Friday, March 17 94

6.19 Feb 28, 2017: Novartis shareholders approve all resolutions proposed by Board of Directors at the Annual General Meeting 94

6.20 Feb 23, 2017: Ronald E. Blaylock Elected to Pfizer's Board of Directors 95

6.21 Feb 22, 2017: NeoGenomics Reports 122% Revenue Growth to $60.5 Million and 11% Reduction in Average Cost per Test in the Fourth Quarter of 2016 95

6.22 Feb 16, 2017: Laboratory Corporation of America Holdings Announces Record 2016 Fourth Quarter and Full Year Results and Provides 2017 Guidance 97

6.23 Feb 02, 2017: BD Announces Results For 2017 First Fiscal Quarter 100

6.24 Feb 01, 2017: QIAGEN Reports Results for Fourth Quarter and Full-year 2016 101

6.25 Jan 31, 2017: Pfizer Reports Fourth-Quarter And Full-Year 2016 Results 105

6.26 Jan 31, 2017: Kyowa Hakko Kirin Establishes Kyowa Kirin Frontier 111

6.27 Jan 30, 2017: Stephen Gottschalk, M.D., has been named chair of the Department of Bone Marrow Transplantation and Cellular Therapy at St. Jude Children's Research Hospital 112

6.28 Jan 26, 2017: Novartis highlights progress towards access and environmental goals in 2016 Corporate Responsibility Performance Report 112

6.29 Jan 26, 2017: Achievement of sales milestone for COPD products 113

6.30 Jan 25, 2017: Novartis delivered solid 2016 performance, with Growth Products absorbing Gleevec US LOE; innovation momentum continued; announces share buyback 114

6.31 Jan 06, 2017: Cancer Genetics Announces Consolidation and Cost Reduction in Administrative and Operational Support Functions 121

6.32 Dec 07, 2016: Stem cell-based test predicts leukemia patients' response to therapy to tailor treatment 122

6.33 Nov 29, 2016: Novartis Access shares one-year learnings and announces memorandum of understanding with Rwanda 123

6.34 Nov 21, 2016: Anthony J. Maddaluna, Executive Vice President and President of Pfizer Global Supply to Retire 124

6.35 Nov 10, 2016: Cancer Genetics Announces Strong Third Quarter with 68% Year over Year Revenue Growth and Highlights Path to Future Profitability 124

6.36 Nov 10, 2016: Diasorin Group Reports Continued Growth In Revenues And Profitability In The Third Quarter 2016 126

6.37 Nov 03, 2016: BD Announces Results For 2016 Fourth Fiscal Quarter And Full Year; Provides Fiscal 2017 Guidance 127

6.38 Nov 02, 2016: QIAGEN Reports Results for Third Quarter and First Nine Months of 2016 129

6.39 Nov 02, 2016: QIAGEN launches restructuring initiatives, revises outlook for 2016 earnings and provides initial net sales and adjusted earnings guidance for 2017 132

6.40 Nov 01, 2016: Pfizer Reports Third-Quarter 2016 Results 132

6.41 Nov 01, 2016: Asuragen Launches QuantideX NGS RNA Lung Cancer Kit 138

6.42 Oct 28, 2016: Kyowa Hakko Kirin Announces Consolidated Financial Results for the First Nine Months Ended September 30, 2016 138

6.43 Oct 26, 2016: Laboratory Corporation of America Holdings Announces 2016 Third Quarter Results and Updates 2016 Guidance 138

6.44 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 141

6.45 Oct 25, 2016: Novartis delivered solid third quarter with Growth Products offsetting Gleevec patent expiration; several positive readouts for potential blockbusters 142

6.46 Sep 26, 2016: Pfizer Decides Remaining One Company Best Positions Company To Maximize Future Value Creation 149

6.47 Sep 20, 2016: LabCorp Names Veteran Biopharma Executive John Ratliff CEO of Covance Drug Development 151

6.48 Sep 07, 2016: Pfizer Appoints Chief Scientific Officer for Neuroscience Research 152

6.49 Aug 09, 2016: Cancer Genetics Reports Second Quarter 2016 Financial Results and Provides Company Updates 152

6.50 Aug 04, 2016: BD Announces Results For 2016 Third Fiscal Quarter 154

6.51 Aug 04, 2016: Diasorin Group Revenues And EBITDA Reached Record highs In the Second Quarter 2016 156

6.52 Aug 02, 2016: Pfizer Reports Second-Quarter 2016 Results 160

6.53 Aug 02, 2016: Kyowa Hakko Kirin Completed of Construction for the Biopharmaceutical API Manufacturing Facility in the Takasaki Plant 164

6.54 Jul 29, 2016: Kyowa Hakko Kirin Announces Consolidated Financial Results for the Six Months Ended June 30, 2016 165

6.55 Jul 28, 2016: QIAGEN Reports Results for Second Quarter of 2016; Increased Commitment to Return $300 Million of Capital to Shareholders by End-2017 165

6.56 Jul 28, 2016: BD Names R. Andrew Eckert To Board Of Directors 169

6.57 Jul 28, 2016: Cepheid Reports Second Quarter 2016 Results 169

6.58 Jul 27, 2016: Laboratory Corporation of America Holdings Announces 2016 Second Quarter Results and Raises 2016 Guidance 170

6.59 Jul 26, 2016: NeoGenomics Reports 159% Revenue Growth to $63.1 Million and Strong Gains in Profitability in the Second Quarter of 2016 172

6.60 Jul 19, 2016: Novartis delivered solid Q2 despite full quarter of US Gleevec generic impact; significant positive innovation news strengthens future growth prospects 173

6.61 Jul 13, 2016: Pfizer and NovaMedica announce a strategic partnership in Russia 180

6.62 Jul 05, 2016: Biocept Granted Japanese Patent Covering Microchannel and Antibody Capture 181

6.63 Jul 04, 2016: Exiqon Nomination of candidates for the supervisory board 181

6.64 Jun 30, 2016: Wake Forest Baptist Receives Specialty Pharmacy Accreditation 181

6.65 Jun 27, 2016: Cancer Genetics Names Healthcare Technology Industry Veteran John Jay Roberts as COO and Executive Vice President of Finance 182

6.66 Jun 21, 2016: Rosetta Genomics Receives Approval from New York State for HEME FISH-based Assays 182

7 Appendix 184

7.1 Methodology 184

7.2 About GlobalData 187

7.3 Contact Us 187

7.4 Disclaimer 187

1.2 List of Figures

Figure 1: Leukemia Diagnostic Tests-Pipeline Products by Stage of Development 10

Figure 2: Leukemia Diagnostic Tests-Pipeline Products by Territory 11

Figure 3: Leukemia-Pipeline Products by Regulatory Path 12

Figure 4: Leukemia Diagnostic Tests-Pipeline Products by Estimated Approval Date 13

1.1 List of Tables

Table 1: Leukemia Diagnostic Tests-Pipeline Products by Stage of Development 10

Table 2: Leukemia Diagnostic Tests-Pipeline Products by Territory 11

Table 3: Leukemia Diagnostic Tests-Pipeline Products by Regulatory Path 12

Table 4: Leukemia Diagnostic Tests-Pipeline Products by Estimated Approval Date 13

Table 5: Leukemia Diagnostic Tests Companies-Pipeline Products by Stage of Development 14

Table 6: Leukemia Diagnostic Tests-Pipeline Products by Stage of Development 16

Table 7: Acobiom Pipeline Products & Ongoing Clinical Trials Overview 18

Table 8: Diagnostic Assay-Chronic Myelomonocytic Leukemia-Product Status 18

Table 9: Diagnostic Assay-Chronic Myelomonocytic Leukemia-Product Description 18

Table 10: Aegis Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 19

Table 11: Diagnostic Assay-Leukemia-Product Status 19

Table 12: Diagnostic Assay-Leukemia-Product Description 19

Table 13: BioSense Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

Table 14: Diagnostic Assay-BCR-ABL (+)-Product Status 20

Table 15: Diagnostic Assay-BCR-ABL (+)-Product Description 20

Table 16: Cancer Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 17: LeukA-Leukemia-Product Status 21

Table 18: LeukA-Leukemia-Product Description 21

Table 19: Cell2in Pipeline Products & Ongoing Clinical Trials Overview 22

Table 20: Diagnostic Test-Blood Cancer-Product Status 22

Table 21: Diagnostic Test-Blood Cancer-Product Description 22

Table 22: CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23

Table 23: Diagnostic Test For Leukemia-Product Status 23

Table 24: Diagnostic Test For Leukemia-Product Description 23

Table 25: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 24

Table 26: XPERT CLL Monitoring Test-Product Status 24

Table 27: XPERT CLL Monitoring Test-Product Description 24

Table 28: Di.V.A.L Toscana srl Pipeline Products & Ongoing Clinical Trials Overview 25

Table 29: NanoMabKv-Leukemia-Product Status 25

Table 30: NanoMabKv-Leukemia-Product Description 25

Table 31: DiaSorin S.p.A Pipeline Products & Ongoing Clinical Trials Overview 26

Table 32: BCR-ABL P190 + ABL Assay-Product Status 26

Table 33: BCR-ABL P190 + ABL Assay-Product Description 27

Table 34: C-Kit 816 Assay-Product Status 27

Table 35: C-Kit 816 Assay-Product Description 27

Table 36: C-Kit 822 Assay-Product Status 27

Table 37: C-Kit 822 Assay-Product Description 28

Table 38: LIAISON IAM-Acute Lymphoblastic Leukemia Test-Product Status 28

Table 39: LIAISON IAM-Acute Lymphoblastic Leukemia Test-Product Description 28

Table 40: LIAISON IAM-Acute Promyelocytic Leukemia Test-Product Status 29

Table 41: LIAISON IAM-Acute Promyelocytic Leukemia Test-Product Description 29

Table 42: PML-RAR1 + ABL Assay-Product Status 29

Table 43: PML-RAR1 + ABL Assay-Product Description 30

Table 44: PML-RAR2 + ABL Assay-Product Status 30

Table 45: PML-RAR2 + ABL Assay-Product Description 30

Table 46: PML-RAR3 + ABL Assay-Product Status 31

Table 47: PML-RAR3 + ABL Assay-Product Description 31

Table 48: Eutropics Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 49: EU-4030 Companion Diagnostic Assay-AML-Product Status 32

Table 50: EU-4030 Companion Diagnostic Assay-AML-Product Description 33

Table 51: EU-5013 Companion Diagnostic Assay-AML-Product Status 33

Table 52: EU-5013 Companion Diagnostic Assay-AML-Product Description 33

Table 53: PraediCare Alvocidib Companion Diagnostic Assay-Acute Myeloid Leukemia-Product Status 34

Table 54: PraediCare Alvocidib Companion Diagnostic Assay-Acute Myeloid Leukemia-Product Description 34

Table 55: PraediCareDx Companion Diagnostic Assay-Alvocidib-Product Status 34

Table 56: PraediCareDx Companion Diagnostic Assay-Alvocidib-Product Description 35

Table 57: H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 58: Diagnostic Assay-Acute Myeloid Leukemia (AML) M5 Subtype-Product Status 36

Table 59: Diagnostic Assay-Acute Myeloid Leukemia (AML) M5 Subtype-Product Description 36

Table 60: Health Discovery Corp Pipeline Products & Ongoing Clinical Trials Overview 37

Table 61: Diagnostic Test-Pre-Leukemia-Product Status 37

Table 62: Diagnostic Test-Pre-Leukemia-Product Description 37

Table 63: IV Diagnostics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

Table 64: Diagnostic Test-Leukemia-Product Status 38

Table 65: Diagnostic Test-Leukemia-Product Description 38

Table 66: Jaden BioScience Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

Table 67: Ultrasensitive Assay-B-Cell Chronic Lymphocytic Leukemia-Product Status 39

Table 68: Ultrasensitive Assay-B-Cell Chronic Lymphocytic Leukemia-Product Description 39

Table 69: King's College London Pipeline Products & Ongoing Clinical Trials Overview 40

Table 70: PARPi Sensitivity Test-AML-Product Status 40

Table 71: PARPi Sensitivity Test-AML-Product Description 40

Table 72: Microfluidic Innovations LLC Pipeline Products & Ongoing Clinical Trials Overview 41

Table 73: Companion Diagnostic Test-Chronic Myeloid Leukemia-Product Status 41

Table 74: Companion Diagnostic Test-Chronic Myeloid Leukemia-Product Description 41

Table 75: Monoquant Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 42

Table 76: PCR-Based Diagnostic Test-Chronic Myeloid Leukemia-Product Status 42

Table 77: PCR-Based Diagnostic Test-Chronic Myeloid Leukemia-Product Description 42

Table 78: Nodality Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 79: Acute Myeloid Leukemia Induction Response Test-Product Status 43

Table 80: Acute Myeloid Leukemia Induction Response Test-Product Description 43

Table 81: NuCana BioMed Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

Table 82: NUC-10000 Companion Diagnostic Test-Product Status 44

Table 83: NUC-10000 Companion Diagnostic Test-Product Description 44

Table 84: NUC-11000 Companion Diagnostic Test-Product Status 45

Table 85: NUC-11000 Companion Diagnostic Test-Product Description 45

Table 86: NUC-12000 Companion Diagnostic Test-Product Status 45

Table 87: NUC-12000 Companion Diagnostic Test-Product Description 46

Table 88: NUC-6285 Companion Diagnostic Test-Product Status 46

Table 89: NUC-6285 Companion Diagnostic Test-Product Description 46

Table 90: NUC-7000 Companion Diagnostic Test-Product Status 47

Table 91: NUC-7000 Companion Diagnostic Test-Product Description 47

Table 92: NUC-8000 Companion Diagnostic Test-Product Status 47

Table 93: NUC-8000 Companion Diagnostic Test-Product Description 48

Table 94: Nuclea Biotechnologies Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49

Table 95: CML Detection Test-Product Status 49

Table 96: CML Detection Test-Product Description 49

Table 97: MLL Detection Test-Product Status 50

Table 98: MLL Detection Test-Product Description 50

Table 99: OncoVista Innovative Therapies Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Table 100: OVI-123(Cordycepin) Biomarker-Leukemia-Product Status 51

Table 101: OVI-123(Cordycepin) Biomarker-Leukemia-Product Description 51

Table 102: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

Table 103: Companion Diagnostic Test-Obinutuzumab-Product Status 52

Table 104: Companion Diagnostic Test-Obinutuzumab-Product Description 52

Table 105: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 53

Table 106: Companion Diagnostic Test-Inotuzumab Ozogamicin-Product Status 53

Table 107: Companion Diagnostic Test-Inotuzumab Ozogamicin-Product Description 53

Table 108: SkylineDx BV Pipeline Products & Ongoing Clinical Trials Overview 54

Table 109: AMLProfiler-Product Status 54

Table 110: AMLProfiler-Product Description 54

Table 111: St. Jude Childrens Research Hospital Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Table 112: Biomarker Based Assay-MRD ALL-Product Status 55

Table 113: Biomarker Based Assay-MRD ALL-Product Description 55

Table 114: Diagnostic Assay-MRD In Leukemia-Product Status 56

Table 115: Diagnostic Assay-MRD In Leukemia-Product Description 56

Table 116: Stanford University Pipeline Products & Ongoing Clinical Trials Overview 57

Table 117: Anti-AF5 Monoclonal Antibody Assay-Product Status 57

Table 118: Anti-AF5 Monoclonal Antibody Assay-Product Description 57

Table 119: The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 58

Table 120: Prognostic Test-Chronic Lymphocytic Leukemia-Product Status 58

Table 121: Prognostic Test-Chronic Lymphocytic Leukemia-Product Description 58

Table 122: Treos Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Table 123: PolyPEPI 513 CDx-Product Status 59

Table 124: PolyPEPI 513 CDx-Product Description 59

Table 125: University of Bergen Pipeline Products & Ongoing Clinical Trials Overview 60

Table 126: Prognostic Marker Test-Leukemia-Product Status 60

Table 127: Prognostic Marker Test-Leukemia-Product Description 60

Table 128: University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 61

Table 129: Biomarker Assay-Chronic Lymphocytic Leukemia-Product Status 61

Table 130: Biomarker Assay-Chronic Lymphocytic Leukemia-Product Description 61

Table 131: ROR1 Monoclonal Antibody Assay-Product Status 62

Table 132: ROR1 Monoclonal Antibody Assay-Product Description 62

Table 133: University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 63

Table 134: Molecular Probe Assay-Acute Myeloid Leukemia-Product Status 63

Table 135: Molecular Probe Assay-Acute Myeloid Leukemia-Product Description 63

Table 136: University of Missouri Pipeline Products & Ongoing Clinical Trials Overview 64

Table 137: Multiple Methylation Sensitive Enzyme Restriction PCR (MSR-PCR) Assay-Product Status 64

Table 138: Multiple Methylation Sensitive Enzyme Restriction PCR (MSR-PCR) Assay-Product Description 64

Table 139: University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview 65

Table 140: xMELP Assay-Product Status 65

Table 141: xMELP Assay-Product Description 65

Table 142: Vela Diagnostics Pte. Ltd Pipeline Products & Ongoing Clinical Trials Overview 66

Table 143: Sentosa SQ Leukemia Panel-Product Status 66

Table 144: Sentosa SQ Leukemia Panel-Product Description 66

Table 145: Vivia Biotech SL Pipeline Products & Ongoing Clinical Trials Overview 67

Table 146: Personalized Medicine Test-Acute Lymphocytic Leukemia-Product Status 67

Table 147: Personalized Medicine Test-Acute Lymphocytic Leukemia-Product Description 67

Table 148: Personalized Medicine Test-Chronic Lymphocytic Leukemia-Product Status 68

Table 149: Personalized Medicine Test-Chronic Lymphocytic Leukemia-Product Description 68

Table 150: Wake Forest Baptist Medical Center Pipeline Products & Ongoing Clinical Trials Overview 69

Table 151: Diagnostic Assay-Acute Erythroid Leukemia-Product Status 69

Table 152: Diagnostic Assay-Acute Erythroid Leukemia-Product Description 69

Table 153: Glossary 186

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Acobiom, Aegis Sciences Corp, BioSense Technologies, Inc., Cancer Genetics Inc, Cell2in, CeMines, Inc., Cepheid, Di.V.A.L Toscana srl , DiaSorin S.p.A, Eutropics Pharmaceuticals Inc, H. Lee Moffitt Cancer Center & Research Institute Inc, Health Discovery Corp, IV Diagnostics, Inc., Jaden BioScience Inc., King's College London, Microfluidic Innovations LLC, Monoquant Pty. Ltd., Nodality Inc, NuCana BioMed Ltd, Nuclea Biotechnologies Inc., OncoVista Innovative Therapies Inc, Roche Diagnostics International Ltd, Siemens Healthcare GmbH, SkylineDx BV, St. Jude Children's Research Hospital Inc, Stanford University, The Feinstein Institute for Medical Research, Treos Bio Inc, University of Bergen, University of California San Diego, University of Colorado, University of Missouri, University of Pennsylvania, Vela Diagnostics Pte. Ltd, Vivia Biotech SL, Wake Forest Baptist Medical Center

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