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Inborn Gene or Chromosome Alterations - Pipeline Review, 2015

Summary

GlobalData's Medical Devices sector report, “Inborn Gene or Chromosome Alterations - Pipeline Review, 2015" provides an overview of genetic tests for Inborn Gene or Chromosome Alterations 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 genetic tests for Inborn Gene or Chromosome Alterations 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 genetic tests for Inborn Gene or Chromosome Alterations 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 genetic tests for Inborn Gene or Chromosome Alterations 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 genetic tests for Inborn Gene or Chromosome Alterations 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

Table Of Contents

Inborn Gene or Chromosome Alterations - Pipeline Review, 2015
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 10
2 Introduction 11
2.1 Inborn Gene or Chromosome Alterations Overview 11
3 Products under Development 12
3.1 Inborn Gene or Chromosome Alterations - Pipeline Products by Stage of Development 12
3.2 Inborn Gene or Chromosome Alterations - Pipeline Products by Territory 13
3.3 Inborn Gene or Chromosome Alterations - Pipeline Products by Regulatory Path 14
3.4 Inborn Gene or Chromosome Alterations - Pipeline Products by Estimated Approval Date 15
3.5 Inborn Gene or Chromosome Alterations - Ongoing Clinical Trials 16
4 Inborn Gene or Chromosome Alterations - Pipeline Products under Development by Companies 17
4.1 Inborn Gene or Chromosome Alterations Companies - Pipeline Products by Stage of Development 17
4.2 Inborn Gene or Chromosome Alterations - Pipeline Products by Stage of Development 20
5 Inborn Gene or Chromosome Alterations Companies and Product Overview 23
5.1 AC-Gen Reading Life S.L. Company Overview 23
5.1.1 AC-Gen Reading Life S.L. Pipeline Products and Ongoing Clinical Trials Overview 23
5.2 Admera Health, LLC Company Overview 24
5.2.1 Admera Health, LLC Pipeline Products and Ongoing Clinical Trials Overview 24
5.3 Agena Bioscience, Inc Company Overview 25
5.3.1 Agena Bioscience, Inc Pipeline Products and Ongoing Clinical Trials Overview 25
5.4 Ariosa Diagnostics, Inc. Company Overview 29
5.4.1 Ariosa Diagnostics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 29
5.5 Atomic International Company Overview 30
5.5.1 Atomic International Pipeline Products and Ongoing Clinical Trials Overview 30
5.6 Baylor College of Medicine Company Overview 31
5.6.1 Baylor College of Medicine Pipeline Products and Ongoing Clinical Trials Overview 31
5.7 BCML GmbH Company Overview 33
5.7.1 BCML GmbH Pipeline Products and Ongoing Clinical Trials Overview 33
5.8 BioCeps (Inactive) Company Overview 34
5.8.1 BioCeps (Inactive) Pipeline Products and Ongoing Clinical Trials Overview 34
5.9 CardioDx, Inc. Company Overview 35
5.9.1 CardioDx, Inc. Pipeline Products and Ongoing Clinical Trials Overview 35
5.10 Celera Corporation Company Overview 37
5.10.1 Celera Corporation Pipeline Products and Ongoing Clinical Trials Overview 37
5.11 Celula, Inc. Company Overview 41
5.11.1 Celula, Inc. Pipeline Products and Ongoing Clinical Trials Overview 41
5.12 Children's Hospital Boston Company Overview 42
5.12.1 Children's Hospital Boston Pipeline Products and Ongoing Clinical Trials Overview 42
5.13 China Medical Technologies, Inc. Company Overview 45
5.13.1 China Medical Technologies, Inc. Pipeline Products and Ongoing Clinical Trials Overview 45
5.14 Da An Gene Co., Ltd. Company Overview 48
5.14.1 Da An Gene Co., Ltd. Pipeline Products and Ongoing Clinical Trials Overview 48
5.15 Dana-Farber Cancer Institute, Inc. Company Overview 51
5.15.1 Dana-Farber Cancer Institute, Inc. Pipeline Products and Ongoing Clinical Trials Overview 51
5.16 Epinex Diagnostics Incorporated Company Overview 53
5.16.1 Epinex Diagnostics Incorporated Pipeline Products and Ongoing Clinical Trials Overview 53
5.17 Genentech, Inc. Company Overview 54
5.17.1 Genentech, Inc. Pipeline Products and Ongoing Clinical Trials Overview 54
5.18 German Cancer Research Center Company Overview 55
5.18.1 German Cancer Research Center Pipeline Products and Ongoing Clinical Trials Overview 55
5.19 GILUPI Nanomedizin Company Overview 57
5.19.1 GILUPI Nanomedizin Pipeline Products and Ongoing Clinical Trials Overview 57
5.20 Hadassah Medical Center Company Overview 58
5.20.1 Hadassah Medical Center Pipeline Products and Ongoing Clinical Trials Overview 58
5.21 Helicos BioSciences Corporation Company Overview 59
5.21.1 Helicos BioSciences Corporation Pipeline Products and Ongoing Clinical Trials Overview 59
5.22 Illumina, Inc. Company Overview 60
5.22.1 Illumina, Inc. Pipeline Products and Ongoing Clinical Trials Overview 60
5.23 IntegraGen SA Company Overview 62
5.23.1 IntegraGen SA Pipeline Products and Ongoing Clinical Trials Overview 62
5.24 Interleukin Genetics, Inc. Company Overview 64
5.24.1 Interleukin Genetics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 64
5.25 JS Genetics Inc. Company Overview 66
5.25.1 JS Genetics Inc. Pipeline Products and Ongoing Clinical Trials Overview 66
5.26 Laboratory Corporation of America Holdings Company Overview 67
5.26.1 Laboratory Corporation of America Holdings Pipeline Products and Ongoing Clinical Trials Overview 67
5.27 Laval University Company Overview 69
5.27.1 Laval University Pipeline Products and Ongoing Clinical Trials Overview 69
5.28 LifeCodexx AG Company Overview 70
5.28.1 LifeCodexx AG Pipeline Products and Ongoing Clinical Trials Overview 70
5.29 Maastricht University Medical Center Company Overview 71
5.29.1 Maastricht University Medical Center Pipeline Products and Ongoing Clinical Trials Overview 71
5.30 Massachusetts Eye and Ear Infirmary Company Overview 72
5.30.1 Massachusetts Eye and Ear Infirmary Pipeline Products and Ongoing Clinical Trials Overview 72
5.31 Medical Research Council Company Overview 74
5.31.1 Medical Research Council Pipeline Products and Ongoing Clinical Trials Overview 74
5.32 Micromedic Technologies Ltd Company Overview 75
5.32.1 Micromedic Technologies Ltd Pipeline Products and Ongoing Clinical Trials Overview 75
5.33 Multiplicom N.V. Company Overview 76
5.33.1 Multiplicom N.V. Pipeline Products and Ongoing Clinical Trials Overview 76
5.34 Myriad Genetics, Inc. Company Overview 78
5.34.1 Myriad Genetics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 78
5.35 Natera, Inc. Company Overview 80
5.35.1 Natera, Inc. Pipeline Products and Ongoing Clinical Trials Overview 80
5.36 National University of Singapore Company Overview 85
5.36.1 National University of Singapore Pipeline Products and Ongoing Clinical Trials Overview 85
5.37 NewGene Ltd Company Overview 89
5.37.1 NewGene Ltd Pipeline Products and Ongoing Clinical Trials Overview 89
5.38 NX PharmaGen Inc. Company Overview 94
5.38.1 NX PharmaGen Inc. Pipeline Products and Ongoing Clinical Trials Overview 94
5.39 Paragon Medical, Inc. Company Overview 95
5.39.1 Paragon Medical, Inc. Pipeline Products and Ongoing Clinical Trials Overview 95
5.40 Population Diagnostics Inc. Company Overview 96
5.40.1 Population Diagnostics Inc. Pipeline Products and Ongoing Clinical Trials Overview 96
5.41 Qiagen N.V. Company Overview 100
5.41.1 Qiagen N.V. Pipeline Products and Ongoing Clinical Trials Overview 100
5.42 Quantamerix Company Overview 102
5.42.1 Quantamerix Pipeline Products and Ongoing Clinical Trials Overview 102
5.43 Sapien Biosciences Company Overview 103
5.43.1 Sapien Biosciences Pipeline Products and Ongoing Clinical Trials Overview 103
5.44 Seegene, Inc. Company Overview 104
5.44.1 Seegene, Inc. Pipeline Products and Ongoing Clinical Trials Overview 104
5.45 Sequenom, Inc. Company Overview 106
5.45.1 Sequenom, Inc. Pipeline Products and Ongoing Clinical Trials Overview 106
5.46 Stanford University Company Overview 112
5.46.1 Stanford University Pipeline Products and Ongoing Clinical Trials Overview 112
5.47 The Johns Hopkins University Company Overview 114
5.47.1 The Johns Hopkins University Pipeline Products and Ongoing Clinical Trials Overview 114
5.48 The Sheba Medical Center Company Overview 115
5.48.1 The Sheba Medical Center Pipeline Products and Ongoing Clinical Trials Overview 115
5.49 The University of Utah Company Overview 116
5.49.1 The University of Utah Pipeline Products and Ongoing Clinical Trials Overview 116
5.50 TrovaGene, Inc. Company Overview 117
5.50.1 TrovaGene, Inc. Pipeline Products and Ongoing Clinical Trials Overview 117
5.51 University of Colorado Company Overview 121
5.51.1 University of Colorado Pipeline Products and Ongoing Clinical Trials Overview 121
5.52 University of Washington Company Overview 122
5.52.1 University of Washington Pipeline Products and Ongoing Clinical Trials Overview 122
5.53 VitaPath Genetics, Inc. Company Overview 123
5.53.1 VitaPath Genetics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 123
5.54 Xiamen Zeesan Biotech Co.,Ltd Company Overview 124
5.54.1 Xiamen Zeesan Biotech Co.,Ltd Pipeline Products and Ongoing Clinical Trials Overview 124
5.55 Yale University Company Overview 125
5.55.1 Yale University Pipeline Products and Ongoing Clinical Trials Overview 125
6 Inborn Gene or Chromosome Alterations- Recent Developments 126
7 Appendix 165
7.1 Methodology 165
7.2 About GlobalData 167
7.3 Contact Us 168
7.4 Disclaimer 168

1.1 List of Tables
Table 1: Inborn Gene or Chromosome Alterations - Pipeline Products by Stage of Development 12
Table 2: Inborn Gene or Chromosome Alterations - Pipeline Products by Territory 13
Table 3: Inborn Gene or Chromosome Alterations - Pipeline Products by Regulatory Path 14
Table 4: Inborn Gene or Chromosome Alterations - Pipeline Products by Estimated Approval Date 15
Table 5: Inborn Gene or Chromosome Alterations - Ongoing Clinical Trials 16
Table 6: Inborn Gene or Chromosome Alterations Companies - Pipeline Products by Stage of Development 17
Table 7: Inborn Gene or Chromosome Alterations - Pipeline Products by Stage of Development 20
Table 8: AC-Gen Reading Life S.L. Pipeline Products and Ongoing Clinical Trials Overview 23
Table 9: Diagnostic Test - Hereditary Deafness - Product Status 23
Table 10: Diagnostic Test - Hereditary Deafness - Product Description 23
Table 11: Admera Health, LLC Pipeline Products and Ongoing Clinical Trials Overview 24
Table 12: Diagnostic Test - Colorectal Cancer - Product Status 24
Table 13: Diagnostic Test - Colorectal Cancer - Product Description 24
Table 14: Agena Bioscience, Inc Pipeline Products and Ongoing Clinical Trials Overview 25
Table 15: IMPACT Dx Factor V Leiden and Factor II Genotyping Test - Product Status 25
Table 16: IMPACT Dx Factor V Leiden and Factor II Genotyping Test - Product Description 25
Table 17: Sensigene Trisomy 21 Test - Product Status 26
Table 18: Sensigene Trisomy 21 Test - Product Description 26
Table 19: Agena Bioscience, Inc - Ongoing Clinical Trials Overview 27
Table 20: Sensigene Trisomy 21 Test - Non-Invasive Screening For Fetal Aneuploidy: A New Maternal Plasma Marker 28
Table 21: Ariosa Diagnostics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 29
Table 22: Harmony Prenatal Test - Product Status 29
Table 23: Harmony Prenatal Test - Product Description 29
Table 24: Atomic International Pipeline Products and Ongoing Clinical Trials Overview 30
Table 25: Thrombophilia Genotyping Assay - Product Status 30
Table 26: Thrombophilia Genotyping Assay - Product Description 30
Table 27: Baylor College of Medicine Pipeline Products and Ongoing Clinical Trials Overview 31
Table 28: Diagnostic Assay - Rett Syndrome - Product Status 31
Table 29: Diagnostic Assay - Rett Syndrome - Product Description 31
Table 30: DNA Test - Autosomal Dominant Cerebellar Ataxia - Product Status 32
Table 31: DNA Test - Autosomal Dominant Cerebellar Ataxia - Product Description 32
Table 32: BCML GmbH Pipeline Products and Ongoing Clinical Trials Overview 33
Table 33: Prenatal Diagnosis Biochip - Product Status 33
Table 34: Prenatal Diagnosis Biochip - Product Description 33
Table 35: BioCeps (Inactive) Pipeline Products and Ongoing Clinical Trials Overview 34
Table 36: Prenatal Diagnostic Test - Product Status 34
Table 37: Prenatal Diagnostic Test - Product Description 34
Table 38: CardioDx, Inc. Pipeline Products and Ongoing Clinical Trials Overview 35
Table 39: CardioDx Test - Heart Failure - Product Status 35
Table 40: CardioDx Test - Heart Failure - Product Description 35
Table 41: Genetic Susceptibility Test - Cardiac Arrhythmia - Product Status 36
Table 42: Genetic Susceptibility Test - Cardiac Arrhythmia - Product Description 36
Table 43: Celera Corporation Pipeline Products and Ongoing Clinical Trials Overview 37
Table 44: Celera Thrombophilia Genotyping Assay - Product Status 38
Table 45: Celera Thrombophilia Genotyping Assay - Product Description 38
Table 46: Fragile - X Genotyping Assay - Product Status 39
Table 47: Fragile - X Genotyping Assay - Product Description 39
Table 48: Liver Fibrosis Genotyping Assay - Product Status 40
Table 49: Liver Fibrosis Genotyping Assay - Product Description 40
Table 50: Celula, Inc. Pipeline Products and Ongoing Clinical Trials Overview 41
Table 51: Non-Invasive Pre-Natal Test - Product Status 41
Table 52: Non-Invasive Pre-Natal Test - Product Description 41
Table 53: Children's Hospital Boston Pipeline Products and Ongoing Clinical Trials Overview 42
Table 54: Diagnostic Assay - Cystic Fibrosis - Product Status 43
Table 55: Diagnostic Assay - Cystic Fibrosis - Product Description 43
Table 56: Diagnostic Assay - Developmental Delay - Product Status 44
Table 57: Diagnostic Assay - Developmental Delay - Product Description 44
Table 58: China Medical Technologies, Inc. Pipeline Products and Ongoing Clinical Trials Overview 45
Table 59: FISH Diagnostic Test - Soft Tissue Sarcoma - Product Status 46
Table 60: FISH Diagnostic Test - Soft Tissue Sarcoma - Product Description 46
Table 61: FISH Diagnostic Test - Urology - Product Status 47
Table 62: FISH Diagnostic Test - Urology - Product Description 47
Table 63: Da An Gene Co., Ltd. Pipeline Products and Ongoing Clinical Trials Overview 48
Table 64: Real Time PCR Kit - Alpha-Mediterranean Anaemia - Product Status 49
Table 65: Real Time PCR Kit - Alpha-Mediterranean Anaemia - Product Description 49
Table 66: Real Time PCR Kit - Beta-Mediterranean Anaemia - Product Status 50
Table 67: Real Time PCR Kit - Beta-Mediterranean Anaemia - Product Description 50
Table 68: Dana-Farber Cancer Institute, Inc. Pipeline Products and Ongoing Clinical Trials Overview 51
Table 69: Diagnostic Assay - Fanconi Anemia - Product Status 51
Table 70: Diagnostic Assay - Fanconi Anemia - Product Description 51
Table 71: Diagnostic Assay - Pancreatic Cancer - Product Status 52
Table 72: Diagnostic Assay - Pancreatic Cancer - Product Description 52
Table 73: Epinex Diagnostics Incorporated Pipeline Products and Ongoing Clinical Trials Overview 53
Table 74: Down Syndrome Screen Test - Product Status 53
Table 75: Down Syndrome Screen Test - Product Description 53
Table 76: Genentech, Inc. Pipeline Products and Ongoing Clinical Trials Overview 54
Table 77: Arbaclofen Companion Diagnostic Assay - Product Status 54
Table 78: Arbaclofen Companion Diagnostic Assay - Product Description 54
Table 79: German Cancer Research Center Pipeline Products and Ongoing Clinical Trials Overview 55
Table 80: CD24 Based Diagnostic Assay - Product Status 55
Table 81: CD24 Based Diagnostic Assay - Product Description 55
Table 82: Monoclonal Antibody - Neurofibromatosis - Product Status 56
Table 83: Monoclonal Antibody - Neurofibromatosis - Product Description 56
Table 84: GILUPI Nanomedizin Pipeline Products and Ongoing Clinical Trials Overview 57
Table 85: Diagnostic Test - Down's Syndrome - Product Status 57
Table 86: Diagnostic Test - Down's Syndrome - Product Description 57
Table 87: Hadassah Medical Center Pipeline Products and Ongoing Clinical Trials Overview 58
Table 88: Gene Based Diagnostic Assay - Antipsychotic Induced Parkinsonism - Product Status 58
Table 89: Gene Based Diagnostic Assay - Antipsychotic Induced Parkinsonism - Product Description 58
Table 90: Helicos BioSciences Corporation Pipeline Products and Ongoing Clinical Trials Overview 59
Table 91: Prenatal Diagnostic Test - Product Status 59
Table 92: Prenatal Diagnostic Test - Product Description 59
Table 93: Illumina, Inc. Pipeline Products and Ongoing Clinical Trials Overview 60
Table 94: Verifi Prenatal Test - Product Status 61
Table 95: Verifi Prenatal Test - Product Description 61
Table 96: IntegraGen SA Pipeline Products and Ongoing Clinical Trials Overview 62
Table 97: ARISk Test - V2.2 - Product Status 63
Table 98: ARISk Test - V2.2 - Product Description 63
Table 99: Interleukin Genetics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 64
Table 100: Inherent Health Osteoarthritis Test - Product Status 65
Table 101: Inherent Health Osteoarthritis Test - Product Description 65
Table 102: JS Genetics Inc. Pipeline Products and Ongoing Clinical Trials Overview 66
Table 103: Dyslexia Predisposition Test - Product Status 66
Table 104: Dyslexia Predisposition Test - Product Description 66
Table 105: Laboratory Corporation of America Holdings Pipeline Products and Ongoing Clinical Trials Overview 67
Table 106: NGS-Based Universal Carrier Screening Test - Product Status 68
Table 107: NGS-Based Universal Carrier Screening Test - Product Description 68
Table 108: Laval University Pipeline Products and Ongoing Clinical Trials Overview 69
Table 109: Trisomy 21 Blood Test - Product Status 69
Table 110: Trisomy 21 Blood Test - Product Description 69
Table 111: LifeCodexx AG Pipeline Products and Ongoing Clinical Trials Overview 70
Table 112: PCR-based NIPT assay - Product Status 70
Table 113: PCR-based NIPT assay - Product Description 70
Table 114: Maastricht University Medical Center Pipeline Products and Ongoing Clinical Trials Overview 71
Table 115: MLPA Test - Product Status 71
Table 116: MLPA Test - Product Description 71
Table 117: Massachusetts Eye and Ear Infirmary Pipeline Products and Ongoing Clinical Trials Overview 72
Table 118: GEDi Test - Inherited Eye Disorders - Product Status 72
Table 119: GEDi Test - Inherited Eye Disorders - Product Description 72
Table 120: GEDi Test - Strabismus - Product Status 73
Table 121: GEDi Test - Strabismus - Product Description 73
Table 122: Medical Research Council Pipeline Products and Ongoing Clinical Trials Overview 74
Table 123: Genetic Test - Familial Hypercholesterolaemia - Product Status 74
Table 124: Genetic Test - Familial Hypercholesterolaemia - Product Description 74
Table 125: Micromedic Technologies Ltd Pipeline Products and Ongoing Clinical Trials Overview 75
Table 126: BONJ Risk Assessment Test - Product Status 75
Table 127: BONJ Risk Assessment Test - Product Description 75
Table 128: Multiplicom N.V. Pipeline Products and Ongoing Clinical Trials Overview 76
Table 129: Clarigo - Product Status 77
Table 130: Clarigo - Product Description 77
Table 131: Myriad Genetics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 78
Table 132: RAD51C Test - Product Status 79
Table 133: RAD51C Test - Product Description 79
Table 134: Natera, Inc. Pipeline Products and Ongoing Clinical Trials Overview 80
Table 135: Anora Natera's Miscarriage Test - Product Status 81
Table 136: Anora Natera's Miscarriage Test - Product Description 81
Table 137: Horizon Multi-Disease Carrier Screening - Product Status 82
Table 138: Horizon Multi-Disease Carrier Screening - Product Description 82
Table 139: Spectrum PGD Test - Product Status 83
Table 140: Spectrum PGD Test - Product Description 83
Table 141: Spectrum PGS Test - Product Status 84
Table 142: Spectrum PGS Test - Product Description 84
Table 143: National University of Singapore Pipeline Products and Ongoing Clinical Trials Overview 85
Table 144: Rapid Screening Assay - Fragile X Syndrome - Product Status 86
Table 145: Rapid Screening Assay - Fragile X Syndrome - Product Description 86
Table 146: Rapid Screening Assay - Fragile X-Associated Tremor Ataxia Syndrome - Product Status 87
Table 147: Rapid Screening Assay - Fragile X-Associated Tremor Ataxia Syndrome - Product Description 87
Table 148: Rapid Screening Assay - Premature Ovarian Failure - Product Status 88
Table 149: Rapid Screening Assay - Premature Ovarian Failure - Product Description 88
Table 150: NewGene Ltd Pipeline Products and Ongoing Clinical Trials Overview 89
Table 151: Diagnostic Test - Colon Cancer - Product Status 90
Table 152: Diagnostic Test - Colon Cancer - Product Description 90
Table 153: Haemolytic Uremic Syndrome Test - Product Status 91
Table 154: Haemolytic Uremic Syndrome Test - Product Description 91
Table 155: Hereditary Non-Polyposis Colorectal Cancer Test - Product Status 92
Table 156: Hereditary Non-Polyposis Colorectal Cancer Test - Product Description 92
Table 157: Limb Girdle Muscular Dystrophy Test - Product Status 93
Table 158: Limb Girdle Muscular Dystrophy Test - Product Description 93
Table 159: NX PharmaGen Inc. Pipeline Products and Ongoing Clinical Trials Overview 94
Table 160: TAME-DX - Prenatal Diagnostic Assay - Product Status 94
Table 161: TAME-DX - Prenatal Diagnostic Assay - Product Description 94
Table 162: Paragon Medical, Inc. Pipeline Products and Ongoing Clinical Trials Overview 95
Table 163: Factor V Leiden For Thrombophilia Test - Product Status 95
Table 164: Factor V Leiden For Thrombophilia Test - Product Description 95
Table 165: Population Diagnostics Inc. Pipeline Products and Ongoing Clinical Trials Overview 96
Table 166: CLIA Waived Genetic Test - Alzheimer's Disease - Product Status 97
Table 167: CLIA Waived Genetic Test - Alzheimer's Disease - Product Description 97
Table 168: CLIA Waived Genetic Test - Autism - Product Status 98
Table 169: CLIA Waived Genetic Test - Autism - Product Description 98
Table 170: CLIA Waived Genetic Test - Parkinson's Disease - Product Status 99
Table 171: CLIA Waived Genetic Test - Parkinson's Disease - Product Description 99
Table 172: Qiagen N.V. Pipeline Products and Ongoing Clinical Trials Overview 100
Table 173: Signature CF Expand - Product Status 101
Table 174: Signature CF Expand - Product Description 101
Table 175: Quantamerix Pipeline Products and Ongoing Clinical Trials Overview 102
Table 176: New Born Screening Diagnostic Device - Product Status 102
Table 177: New Born Screening Diagnostic Device - Product Description 102
Table 178: Sapien Biosciences Pipeline Products and Ongoing Clinical Trials Overview 103
Table 179: Genetic Testing Panel - Perinatal Disease - Product Status 103
Table 180: Genetic Testing Panel - Perinatal Disease - Product Description 103
Table 181: Seegene, Inc. Pipeline Products and Ongoing Clinical Trials Overview 104
Table 182: Seeplex ApoE ACE Genotyping Assay - Product Status 105
Table 183: Seeplex ApoE ACE Genotyping Assay - Product Description 105
Table 184: Sequenom, Inc. Pipeline Products and Ongoing Clinical Trials Overview 106
Table 185: MaterniT GENOME Test - Product Status 107
Table 186: MaterniT GENOME Test - Product Description 107
Table 187: Next Generation Noninvasive Prenatal Test (NIPT) - Product Status 108
Table 188: Next Generation Noninvasive Prenatal Test (NIPT) - Product Description 108
Table 189: Prenatal Diagnostic Test - Product Status 109
Table 190: Prenatal Diagnostic Test - Product Description 109
Table 191: SensiGene Age Related Macular Degeneration Assay - Product Status 110
Table 192: SensiGene Age Related Macular Degeneration Assay - Product Description 110
Table 193: VisibiliT Prenatal Test - Product Status 111
Table 194: VisibiliT Prenatal Test - Product Description 111
Table 195: Stanford University Pipeline Products and Ongoing Clinical Trials Overview 112
Table 196: Diagnostic Kit - Beta Thalassemia Syndrome - Product Status 113
Table 197: Diagnostic Kit - Beta Thalassemia Syndrome - Product Description 113
Table 198: The Johns Hopkins University Pipeline Products and Ongoing Clinical Trials Overview 114
Table 199: Prenatal Diagnostic Test - Product Status 114
Table 200: Prenatal Diagnostic Test - Product Description 114
Table 201: The Sheba Medical Center Pipeline Products and Ongoing Clinical Trials Overview 115
Table 202: Non-Invasive Prenatal Diagnostic Assay - Product Status 115
Table 203: Non-Invasive Prenatal Diagnostic Assay - Product Description 115
Table 204: The University of Utah Pipeline Products and Ongoing Clinical Trials Overview 116
Table 205: Epigenetic Test - Disease Inheritance Risk In Offspring - Product Status 116
Table 206: Epigenetic Test - Disease Inheritance Risk In Offspring - Product Description 116
Table 207: TrovaGene, Inc. Pipeline Products and Ongoing Clinical Trials Overview 117
Table 208: miRNA Test - Alzheimer's Disease - Product Status 118
Table 209: miRNA Test - Alzheimer's Disease - Product Description 118
Table 210: miRNA Test - Brain Stroke - Product Status 119
Table 211: miRNA Test - Brain Stroke - Product Description 119
Table 212: miRNA Test - Kidney Transplantation - Product Status 120
Table 213: miRNA Test - Kidney Transplantation - Product Description 120
Table 214: University of Colorado Pipeline Products and Ongoing Clinical Trials Overview 121
Table 215: CBS Gene Mutation Test - Product Status 121
Table 216: CBS Gene Mutation Test - Product Description 121
Table 217: University of Washington Pipeline Products and Ongoing Clinical Trials Overview 122
Table 218: Diagnostic Test - Ovarian Cancer - Product Status 122
Table 219: Diagnostic Test - Ovarian Cancer - Product Description 122
Table 220: VitaPath Genetics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 123
Table 221: Diagnostic Test - Spina Bifida - Product Status 123
Table 222: Diagnostic Test - Spina Bifida - Product Description 123
Table 223: Xiamen Zeesan Biotech Co.,Ltd Pipeline Products and Ongoing Clinical Trials Overview 124
Table 224: MeltPro HBB Diagnostic Kit - Product Status 124
Table 225: MeltPro HBB Diagnostic Kit - Product Description 124
Table 226: Yale University Pipeline Products and Ongoing Clinical Trials Overview 125
Table 227: Diagnostic Assay - Down Syndrome - Product Status 125
Table 228: Diagnostic Assay - Down Syndrome - Product Description 125
Table 229: Glossary 166

1.2 List of Figures
Figure 1: Inborn Gene or Chromosome Alterations - Pipeline Products by Stage of Development 12
Figure 2: Inborn Gene or Chromosome Alterations - Pipeline Products by Territory 13
Figure 3: Inborn Gene or Chromosome Alterations - Pipeline Products by Regulatory Path 14
Figure 4: Inborn Gene or Chromosome Alterations - Pipeline Products by Estimated Approval Date 15
Figure 5: Inborn Gene or Chromosome Alterations - Ongoing Clinical Trials 16

Companies Mentioned
AC-Gen Reading Life S.L.
Admera Health, LLC
Agena Bioscience, Inc
Ariosa Diagnostics, Inc.
Atomic International
Baylor College of Medicine
BCML GmbH
CardioDx, Inc.
Celera Corporation
Celula, Inc.
Children's Hospital Boston
China Medical Technologies, Inc.

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