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Endocrinology Tests - Medical Devices Pipeline Assessment, 2018

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Details

Endocrinology Tests-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Endocrinology Tests-Medical Devices Pipeline Assessment, 2018" provides an overview of Endocrinology 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 Endocrinology 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 Endocrinology 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 Endocrinology 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 Endocrinology 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.

READ MORE

Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 14

2 Introduction 15

2.1 Endocrinology Tests Overview 15

3 Products under Development 16

3.1 Endocrinology Tests-Pipeline Products by Stage of Development 16

3.2 Endocrinology Tests-Pipeline Products by Segment 17

3.3 Endocrinology Tests-Pipeline Products by Territory 19

3.4 Endocrinology Tests-Pipeline Products by Regulatory Path 20

3.5 Endocrinology Tests-Pipeline Products by Estimated Approval Date 21

4 Endocrinology Tests-Pipeline Products under Development by Companies 22

4.1 Endocrinology Tests Companies-Pipeline Products by Stage of Development 22

4.2 Endocrinology Tests-Pipeline Products by Stage of Development 25

5 Endocrinology Tests Companies and Product Overview 31

5.1 Abbott Diagnostics Company Overview 31

5.2 AgPlus Diagnostics LTD Company Overview 33

5.3 Albert Einstein College of Medicine Company Overview 34

5.4 Alere Inc Company Overview 36

5.5 AMS Diagnostics LLC Company Overview 37

5.6 Aura Biotechnologies Pvt Ltd Company Overview 39

5.7 AXO Science SAS Company Overview 40

5.8 Beckman Coulter Inc Company Overview 41

5.9 Boditech Med Inc Company Overview 47

5.10 Canon Medical Systems Corp Company Overview 48

5.11 Carolina Liquid Chemistries Corp Company Overview 49

5.12 Celmatix Inc Company Overview 51

5.13 Ceres Nanosciences Inc Company Overview 52

5.14 China Medical Technologies Inc (Inactive) Company Overview 53

5.15 Columbia University Company Overview 54

5.16 Denka Seiken Co Ltd Company Overview 55

5.17 DiaSorin SpA Company Overview 56

5.18 DIAsource ImmunoAssays SA Company Overview 60

5.19 EDP Biotech Corporation Company Overview 61

5.20 Ellume Company Overview 62

5.21 Fujirebio Diagnostics Inc Company Overview 63

5.22 GeneFluidics Inc Company Overview 73

5.23 Genovum Sp. z o.o. Company Overview 76

5.24 Hebrew University of Jerusalem Company Overview 77

5.25 Immunodiagnostic Systems Holdings plc Company Overview 79

5.26 Intermountain Healthcare Inc Company Overview 84

5.27 King's College London Company Overview 85

5.28 Laboratoire HRA Pharma SAS Company Overview 86

5.29 Labsystems Diagnostics Oy Company Overview 87

5.30 Lucine Biotechnology, Inc. Company Overview 90

5.31 MDNA Life Sciences Inc Company Overview 91

5.32 MedMira Inc Company Overview 92

5.33 Mindray Medical International Ltd Company Overview 93

5.34 MyHealthTest Pty Ltd Company Overview 102

5.35 Northwestern University Company Overview 103

5.36 Novartis AG Company Overview 105

5.37 Oasis Diagnostics Corp Company Overview 107

5.38 Ohmx Corp Company Overview 108

5.39 OJ-Bio Ltd Company Overview 109

5.40 Orangelife Company Overview 110

5.41 Ortho-Clinical Diagnostics Inc Company Overview 111

5.42 Otsuka Pharmaceutical Co Ltd Company Overview 112

5.43 Paramedical Srl Company Overview 113

5.44 PerkinElmer Inc Company Overview 115

5.45 Proteomika Company Overview 116

5.46 QuickCheck Health Inc Company Overview 117

5.47 Quidel Corp Company Overview 118

5.48 Roche Diagnostics International Ltd Company Overview 120

5.49 Sendera Discovery Company Overview 133

5.50 Shahid Beheshti University Company Overview 134

5.51 Siemens Healthcare GmbH Company Overview 135

5.52 SomaLogic Inc Company Overview 155

5.53 Swan Diagnostics Ltd Company Overview 156

5.54 Sysmex Corp Company Overview 157

5.55 Tecan Group Ltd Company Overview 160

5.56 Thermo Fisher Scientific Inc Company Overview 162

5.57 Tosoh Bioscience Inc Company Overview 164

5.58 University of Edinburgh Company Overview 165

5.59 University of Michigan Company Overview 166

5.60 University of Otago Company Overview 167

5.61 University Rovira i Virgili Company Overview 168

6 Endocrinology Tests- Recent Developments 169

6.1 Jun 21, 2018: Sera Prognostics Appoints Dr. Garrett K. Lam as Chief Medical Officer 169

6.2 Jun 20, 2018: Immunodiagnostic Systems: Final Results for year ended 31 March 2018 170

6.3 Jun 19, 2018: Sera Prognostics Collaborates with Christiana Care Health System to Launch New Preterm Birth Study with PreTRM Test 174

6.4 Jun 13, 2018: Alfa Wassermann Diagnostic Technologies Honored for Delivering 'World-Class' Customer Service 175

6.5 Jun 12, 2018: Change at the top of the Segment Advanced Therapies at Siemens Healthineers 175

6.6 Jun 01, 2018: ISBT Satellite Symposium Co-hosted by Ortho Clinical Diagnostics and Quotient Discusses Responding to the Challenges of Resource Constraints in Transfusion Diagnostics 176

6.7 May 31, 2018: Aeterna Zentaris Appoints Olaf Althaus as General Manager and Managing Director of Aeterna Zentaris GmbH 177

6.8 May 29, 2018: Intermountain Healthcare Launches New Study to Determine Benefit of Proactive Interventions in Reducing Premature Births 177

6.9 May 16, 2018: Novartis announces changes to the Executive Committee 179

6.10 May 16, 2018: At the Meet Novartis Management investor event, Novartis highlights strategy to focus the company and drive sustainable growth 180

6.11 May 10, 2018: Novartis India reconstitutes Board appoints Milan Paleja as Vice Chairman Managing Director 181

6.12 May 09, 2018: Sysmex Group Formulates New Long-Term Management Goals 181

6.13 May 09, 2018: Sysmex Announces Summary of Consolidated Financial Results for the Fiscal Year Ended March 31, 2018 183

6.14 May 08, 2018: The Diasorin Group Reports Growth in Revenues and Profitability in the First Quarter 2018 186

6.15 May 08, 2018: Quidel Announces First Quarter 2018 Financial Results 189

6.16 May 08, 2018: Aeterna Zentaris Announces Results of Annual and Special Shareholders' Meeting 190

6.17 May 08, 2018: Ortho Clinical Diagnostics Holds Summit to Help Asia-Pacific Lab Leaders Envision the Lab of the Future 191

6.18 May 07, 2018: Luminex Announces First Quarter 2018 Financial Results 192

6.19 May 07, 2018: Aeterna Zentaris Reports First Quarter 2018 Financial and Operating Results 192

6.20 May 03, 2018: Siemens Healthineers fully on track to meet the targets 194

6.21 May 02, 2018: Novo Nordisk's operating profit decreased by 8% in Danish kroner and increased by 6% in local currencies in the first three months of 2018 195

6.22 May 01, 2018: Veracyte Reports First Quarter 2018 Financial Results 196

7 Appendix 329

7.1 Methodology 329

7.2 About GlobalData 332

7.3 Contact Us 332

7.4 Disclaimer 332


List Of Figure

1.2 List of Figures

Figure 1: Endocrinology Tests-Pipeline Products by Stage of Development 18

Figure 2: Endocrinology Tests-Pipeline Products by Segment 19

Figure 3: Endocrinology Tests-Pipeline Products by Territory 21

Figure 4: Endocrinology Tests-Pipeline Products by Regulatory Path 22

Figure 5: Endocrinology Tests-Pipeline Products by Estimated Approval Date 23


List Of Table

1.1 List of Tables

Table 1: Endocrinology Tests-Pipeline Products by Stage of Development 18

Table 2: Endocrinology Tests-Pipeline Products by Segment 19

Table 3: Endocrinology Tests-Pipeline Products by Territory 21

Table 4: Endocrinology Tests-Pipeline Products by Regulatory Path 22

Table 5: Endocrinology Tests-Pipeline Products by Estimated Approval Date 23

Table 6: Endocrinology Tests Companies-Pipeline Products by Stage of Development 24

Table 7: Endocrinology Tests-Pipeline Products by Stage of Development 27

Table 8: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 33

Table 9: Alinity ci-Hormone Deficiency-Product Status 33

Table 10: Alinity ci-Hormone Deficiency-Product Description 33

Table 11: Alinity ci-Thyroid Disease-Product Status 34

Table 12: Alinity ci-Thyroid Disease-Product Description 34

Table 13: AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 35

Table 14: AgPlus Diagnostic System-Testosterone Assay-Product Status 35

Table 15: AgPlus Diagnostic System-Testosterone Assay-Product Description 35

Table 16: Albert Einstein College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 36

Table 17: Cortisol Assay-Product Status 36

Table 18: Cortisol Assay-Product Description 36

Table 19: Estradiol Assay-Product Status 37

Table 20: Estradiol Assay-Product Description 37

Table 21: Progesterone Assay-Product Status 37

Table 22: Progesterone Assay-Product Description 37

Table 23: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 24: Vitamin D Assay-Product Status 38

Table 25: Vitamin D Assay-Product Description 38

Table 26: AMS Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 39

Table 27: LIASYS 330-Vitamin D Assay-Product Status 39

Table 28: LIASYS 330-Vitamin D Assay-Product Description 39

Table 29: Liasys 450-Vitamin D Assay-Product Status 39

Table 30: Liasys 450-Vitamin D Assay-Product Description 40

Table 31: Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

Table 32: AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit-Product Status 41

Table 33: AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit-Product Description 41

Table 34: AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 42

Table 35: Multiplexed Detection-TSH-Product Status 42

Table 36: Multiplexed Detection-TSH-Product Description 42

Table 37: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 38: Access 2 Immunoassay System-Sensitive Estradiol-Product Status 43

Table 39: Access 2 Immunoassay System-Sensitive Estradiol-Product Description 44

Table 40: UniCel DxC 660i Synchron Access Clinical System-AMH Assay-Product Status 44

Table 41: UniCel DxC 660i Synchron Access Clinical System-AMH Assay-Product Description 44

Table 42: UniCel DxI 600 Access Immunoassay System-AMH Assay-Product Status 44

Table 43: UniCel DxI 600 Access Immunoassay System-AMH Assay-Product Description 45

Table 44: UniCel DxI 600 Access Immunoassay System-Sensitive Estradiol Assay-Product Status 45

Table 45: UniCel DxI 600 Access Immunoassay System-Sensitive Estradiol Assay-Product Description 45

Table 46: UniCel DxI 600 Access Immunoassay System-TSH (3rd IS) Assay-Product Status 45

Table 47: UniCel DxI 600 Access Immunoassay System-TSH (3rd IS) Assay-Product Description 46

Table 48: UniCel DxI 800 Access Immunoassay System-AMH Assay-Product Status 46

Table 49: UniCel DxI 800 Access Immunoassay System-AMH Assay-Product Description 46

Table 50: UniCel DxI 800 Access Immunoassay System-Sensitive Estradiol Assay-Product Status 46

Table 51: UniCel DxI 800 Access Immunoassay System-Sensitive Estradiol Assay-Product Description 47

Table 52: UniCel DxI 800 Access Immunoassay System-TSH (3rd IS) Assay-Product Status 47

Table 53: UniCel DxI 800 Access Immunoassay System-TSH (3rd IS) Assay-Product Description 47

Table 54: UniCel DxI 860i Synchron Access Clinical System-Vitamin D Assay-Product Status 47

Table 55: UniCel DxI 860i Synchron Access Clinical System-Vitamin D Assay-Product Description 48

Table 56: Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 49

Table 57: AFIAS-6 Progesterone Assay-Product Status 49

Table 58: AFIAS-6 Progesterone Assay-Product Description 49

Table 59: Canon Medical Systems Corp Pipeline Products & Ongoing Clinical Trials Overview 50

Table 60: Diagnostic Test-Thyroid Disorders-Product Status 50

Table 61: Diagnostic Test-Thyroid Disorders-Product Description 50

Table 62: Carolina Liquid Chemistries Corp Pipeline Products & Ongoing Clinical Trials Overview 51

Table 63: CLC 480 Analyzer-Vitamin D Assay-Product Status 51

Table 64: CLC 480 Analyzer-Vitamin D Assay-Product Description 51

Table 65: CLC 720i Analyzer-Vitamin D Assay-Product Status 52

Table 66: CLC 720i Analyzer-Vitamin D Assay-Product Description 52

Table 67: Celmatix Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Table 68: FertilArray-Product Status 53

Table 69: FertilArray-Product Description 53

Table 70: Ceres Nanosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Table 71: Nanotrap Human Growth Hormone Test-Product Status 54

Table 72: Nanotrap Human Growth Hormone Test-Product Description 54

Table 73: China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 55

Table 74: Infertility Reagent Test kit-ECLIA Analyzer-Product Status 55

Table 75: Infertility Reagent Test kit-ECLIA Analyzer-Product Description 55

Table 76: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 56

Table 77: Diagnostic Test-Menopause-Product Status 56

Table 78: Diagnostic Test-Menopause-Product Description 56

Table 79: Denka Seiken Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Table 80: Adiponectin Assay Kit-Product Status 57

Table 81: Adiponectin Assay Kit-Product Description 57

Table 82: DiaSorin SpA Pipeline Products & Ongoing Clinical Trials Overview 58

Table 83: Estradiol II Assay-Product Status 58

Table 84: Estradiol II Assay-Product Description 58

Table 85: LIAISON-High Sclerostin Assay-Product Status 59

Table 86: LIAISON-High Sclerostin Assay-Product Description 59

Table 87: LIAISON-Hyperphosphate Low Bone Turnover Assay-Product Status 59

Table 88: LIAISON-Hyperphosphate Low Bone Turnover Assay-Product Description 60

Table 89: LIAISON XL-Sclerostin Assay-Product Status 60

Table 90: LIAISON XL-Sclerostin Assay-Product Description 60

Table 91: Progesterone II Assay-Product Status 61

Table 92: Progesterone II Assay-Product Description 61

Table 93: DIAsource ImmunoAssays SA Pipeline Products & Ongoing Clinical Trials Overview 62

Table 94: 25-OH Vitamin D Total ELISA Test-Product Status 62

Table 95: 25-OH Vitamin D Total ELISA Test-Product Description 62

Table 96: EDP Biotech Corporation Pipeline Products & Ongoing Clinical Trials Overview 63

Table 97: Diagnostic Assay-Early Conception Factor-Product Status 63

Table 98: Diagnostic Assay-Early Conception Factor-Product Description 63

Table 99: Ellume Pipeline Products & Ongoing Clinical Trials Overview 64

Table 100: ESP-Based Diagnostic Test-Pregnancy-Product Status 64

Table 101: ESP-Based Diagnostic Test-Pregnancy-Product Description 64

Table 102: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 65

Table 103: Lumipulse G-AFP Assay-Product Status 65

Table 104: Lumipulse G-AFP Assay-Product Description 66

Table 105: Lumipulse G-FT3 Assay-Product Status 66

Table 106: Lumipulse G-FT3 Assay-Product Description 66

Table 107: Lumipulse G-FT4 Assay-Product Status 67

Table 108: Lumipulse G-FT4 Assay-Product Description 67

Table 109: Lumipulse G-T3 Assay-Product Status 67

Table 110: Lumipulse G-T3 Assay-Product Description 68

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Products and Companies

Products

Abbott Diagnostics, Alinity ci - Hormone Deficiency; Abbott Diagnostics, Alinity ci - Thyroid Disease; AgPlus Diagnostics LTD, AgPlus Diagnostic System - Testosterone Assay; Albert Einstein College of Medicine, Cortisol Assay; Albert Einstein College of Medicine, Estradiol Assay; Albert Einstein College of Medicine, Progesterone Assay; Alere Inc, Vitamin D Assay; AMS Diagnostics LLC, LIASYS 330 - Vitamin D Assay; AMS Diagnostics LLC, Liasys 450 - Vitamin D Assay; Aura Biotechnologies Pvt Ltd, AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit; AXO Science SAS, Multiplexed Detection - TSH; Beckman Coulter Inc, Access 2 Immunoassay System - Sensitive Estradiol; Beckman Coulter Inc, UniCel DxC 660i Synchron Access Clinical System - AMH Assay; Beckman Coulter Inc, UniCel DxI 600 Access Immunoassay System - AMH Assay; Beckman Coulter Inc, UniCel DxI 600 Access Immunoassay System - Sensitive Estradiol Assay; Beckman Coulter Inc, UniCel DxI 600 Access Immunoassay System - TSH (3rd IS) Assay; Beckman Coulter Inc, UniCel DxI 800 Access Immunoassay System - AMH Assay; Beckman Coulter Inc, UniCel DxI 800 Access Immunoassay System - Sensitive Estradiol Assay; Beckman Coulter Inc, UniCel DxI 800 Access Immunoassay System - TSH (3rd IS) Assay; Beckman Coulter Inc, UniCel DxI 860i Synchron Access Clinical System - Vitamin D Assay; Boditech Med Inc, AFIAS-6 Progesterone Assay; Canon Medical Systems Corp, Diagnostic Test - Thyroid Disorders; Carolina Liquid Chemistries Corp, CLC 480 Analyzer - Vitamin D Assay; Carolina Liquid Chemistries Corp, CLC 720i Analyzer - Vitamin D Assay; Celmatix Inc, FertilArray; Ceres Nanosciences Inc, Nanotrap Human Growth Hormone Test; China Medical Technologies Inc (Inactive), Infertility Reagent Test kit - ECLIA Analyzer; Columbia University, Diagnostic Test - Menopause; Denka Seiken Co Ltd, Adiponectin Assay Kit; DiaSorin SpA, Estradiol II Assay; DiaSorin SpA, LIAISON - High Sclerostin Assay; DiaSorin SpA, LIAISON - Hyperphosphate Low Bone Turnover Assay; DiaSorin SpA, LIAISON XL - Sclerostin Assay; DiaSorin SpA, Progesterone II Assay; DIAsource ImmunoAssays SA, 25-OH Vitamin D Total ELISA Test; EDP Biotech Corporation, Diagnostic Assay - Early Conception Factor; Ellume, ESP-Based Diagnostic Test - Pregnancy; Fujirebio Diagnostics Inc, Lumipulse G - AFP Assay; Fujirebio Diagnostics Inc, Lumipulse G - FT3 Assay; Fujirebio Diagnostics Inc, Lumipulse G - FT4 Assay; Fujirebio Diagnostics Inc, Lumipulse G - T3 Assay; Fujirebio Diagnostics Inc, Lumipulse G - T4 Assay; Fujirebio Diagnostics Inc, Lumipulse G - TgAb Assay; Fujirebio Diagnostics Inc, Lumipulse G - TPOAb Assay; Fujirebio Diagnostics Inc, Lumipulse G1200 - AMH; Fujirebio Diagnostics Inc, Lumipulse G1200 - Estradiol Assay; Fujirebio Diagnostics Inc, Lumipulse G1200 - FSH Test; Fujirebio Diagnostics Inc, Lumipulse G1200 - Progestrone Test; Fujirebio Diagnostics Inc, Lumipulse G1200 - Testosterone Assay; Fujirebio Diagnostics Inc, Lumipulse G1200 - Total -HCG Assay; Fujirebio Diagnostics Inc, Lumipulse G1200 - Whole PTH; GeneFluidics Inc, Free T3 Assay; GeneFluidics Inc, Free T4 Assay; GeneFluidics Inc, T3 Assay; GeneFluidics Inc, T4 Assay; Genovum Sp. z o.o., Diagnostic Test - Polycystic Ovarian Syndrome; Hebrew University of Jerusalem, Diagnostic Assay - Ovulation; Hebrew University of Jerusalem, Diagnostic Assay - Pregnancy; Immunodiagnostic Systems Holdings plc, IDS-iSYS - 17-beta Estradiol Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS - Total Testosterone Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS Bioactive PTH (1-84) Kit; Immunodiagnostic Systems Holdings plc, IDS-iSYS Cortisol Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS Free Testosterone Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS Intact PINP Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS MGP Assay; Intermountain Healthcare Inc, Cortisol Assay; King's College London, Elafin Test - Preterm Birth; Laboratoire HRA Pharma SAS, Indigo; Labsystems Diagnostics Oy, Enzymatic Immuno Assay - Neonatal hTSH EIA; Labsystems Diagnostics Oy, Enzymatic Immuno Assay - Neonatal hTSH FEIA Plus; Labsystems Diagnostics Oy, Fluoro Enzymatic Immuno Assay - Neonatal 17-OH-Progesterone FEIA; Labsystems Diagnostics Oy, TSH Point Of Birth; Lucine Biotechnology, Inc., Salivary Diagnostic Test - PCOS; MDNA Life Sciences Inc, Diagnostic Assay - Endocrinology; MedMira Inc, Reveal TSH Single Test; Mindray Medical International Ltd, CL-1000i - Calcitonin Test; Mindray Medical International Ltd, CL-1000i - Intact PTH Test; Mindray Medical International Ltd, CL-1000i - Vitamin D Total Test; Mindray Medical International Ltd, CL-2000i - ACTH Test; Mindray Medical International Ltd, CL-2000i - Anti-TG Test; Mindray Medical International Ltd, CL-2000i - Anti-TPO; Mindray Medical International Ltd, CL-2000i - Calcitonin Test; Mindray Medical International Ltd, CL-2000i - Cortisol Test; Mindray Medical International Ltd, CL-2000i - DHEA-S Test; Mindray Medical International Ltd, CL-2000i - PTH Test; Mindray Medical International Ltd, CL-2000i - Thyroglobulin (TG) Test; Mindray Medical International Ltd, CL-2000i - Vitamin D Total Test; MyHealthTest Pty Ltd, Diagnostic Test - Hormones; Northwestern University, At Home Menopause Test; Northwestern University, Female Fertility Test; Novartis AG, Diagnostic Test - Thyroid Stimulating Hormone; Novartis AG, Rapid Diagnostic Test - Vitamin D; Oasis Diagnostics Corp, VerOFy Salivary Based Test - Estradiol; Ohmx Corp, Portable POC System - Thyroid Stimulating Hormone; OJ-Bio Ltd, Parathyroid Hormone Assay; Orangelife, Pregnancy Kit; Ortho-Clinical Diagnostics Inc, Diagnostic Assay - Thyroid Diseases; Otsuka Pharmaceutical Co Ltd, ODK-1403; Paramedical Srl, PKL PPC 960 - AMH; Paramedical Srl, PKL PPC 960 - Inhibin A; Paramedical Srl, PKL PPC 960 - TRAb; PerkinElmer Inc, Diagnostic Test - Preterm Birth; Proteomika, Proimplant; QuickCheck Health Inc, Diagnostic Test - Pregnancy; Quidel Corp, Dual Block/Stim Assay; Quidel Corp, Thyretain TBI Reporter BioAssay; Roche Diagnostics International Ltd, Cobas 4000 Analyzer Series With e 411 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 6000 Analyzer Series With c 501 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 6000 Analyzer Series With c 501 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 6000 Analyzer Series With e 601 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 6000 Analyzer Series With e 601 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 502 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 502 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 701 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 701 Module - IGF-1; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 702 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 602 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 602 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 801 Module - 17-OH-Progesterone Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 801 Module - Androstenedione Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 801 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 801 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Diagnostic Assay - AMH; Roche Diagnostics International Ltd, Diagnostic Test - IGFBP3; Roche Diagnostics International Ltd, Integrated Modular Analytics system - PAPP-A Test; Sendera Discovery, In-Vitro Diagnostic Kit - Androgen Replacement Therapy; Shahid Beheshti University, Prognostic Test - Menopause; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - Anti-Mullerian Hormone Assay; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - Free hCG Assay; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - PAPP-A Assay; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - Tg Assay; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - Vitamin D Assay; Siemens Healthcare GmbH, ADVIA Centaur XP Immunoassay System - Anti-Mullerian Hormone Assay; Siemens Healthcare GmbH, ADVIA Centaur XP Immunoassay System - Free hCG Assay; Siemens Healthcare GmbH, ADVIA Centaur XP Immunoassay System - PAPP-A Assay; Siemens Healthcare GmbH, ADVIA Centaur XP Immunoassay System - Tg Assay; Siemens Healthcare GmbH, ADVIA Centaur XPT Immunoassay System - Anti-Mullerian Hormone Assay; Siemens Healthcare GmbH, ADVIA Centaur XPT Immunoassay System - Free hCG Assay; Siemens Healthcare GmbH, ADVIA Centaur XPT Immunoassay System - PAPP-A Assay; Siemens Healthcare GmbH, ADVIA Centaur XPT Immunoassay System - Tg Assay; Siemens Healthcare GmbH, Dimension EXL 200 Integrated Chemistry System - LOCI IPTH; Siemens Healthcare GmbH, Dimension EXL 200 Integrated Chemistry System - Vitamin D Assay; Siemens Healthcare GmbH, Dimension EXL with LM Integrated Chemistry System - LOCI Cortisol Assay; Siemens Healthcare GmbH, Dimension EXL with LM Integrated Chemistry System - LOCI IPTH Assay; Siemens Healthcare GmbH, Dimension EXL with LM Integrated Chemistry System - LOCI Vitamin D Assay; Siemens Healthcare GmbH, Dimension EXL With LM Integrated Chemistry System - Vitamin D Assay; Siemens Healthcare GmbH, Dimension Vista 1000T Intelligent Lab System - Cortisol Assay; Siemens Healthcare GmbH, Dimension Vista 1000T Intelligent Lab System - Testosterone Assay; Siemens Healthcare GmbH, Dimension Vista 1500 Intelligent Lab System - Loci Vitamin D Assay; Siemens Healthcare GmbH, Dimension Vista 1500 Intelligent Lab System - Intact PTH Assay; Siemens Healthcare GmbH, Dimension Vista 3000T Intelligent Lab System - Cortisol Assay; Siemens Healthcare GmbH, Dimension Vista 3000T Intelligent Lab System - Testosterone Assay; Siemens Healthcare GmbH, Dimension Vista 500 Intelligent Lab System - Cortisol Assay; Siemens Healthcare GmbH, Dimension Vista 500 Intelligent Lab System - Intact PTH Assay; Siemens Healthcare GmbH, Dimension Vista 500 Intelligent Lab System - Testosterone Assay; Siemens Healthcare GmbH, IMMULITE 1000 Immunoassay System - PAPP-A Assay; Siemens Healthcare GmbH, IMMULITE 1000 Immunoassay System - Free Beta HCG Assay; Siemens Healthcare GmbH, IMMULITE 1000 Immunoassay System - TSI Assay; Siemens Healthcare GmbH, IMMULITE 2000 XPi Immunoassay System - Free Beta HCG Assay; SomaLogic Inc, SOMAscan Assay - Preterm Labor; Swan Diagnostics Ltd, FertiGO; Sysmex Corp, Immunochemistry Test - FSH; Sysmex Corp, Immunochemistry Test - LH; Sysmex Corp, Immunochemistry Test - Tg Ab; Sysmex Corp, Immunochemistry Test - TPO Ab; Sysmex Corp, Immunochemistry Test - TR Ab; Tecan Group Ltd, 17-OH-Progesterone Neonatal Screening Assay; Tecan Group Ltd, Neonatal Screening Assay - Congenital Hypothyroidism; Thermo Fisher Scientific Inc, Cascadion SM Clinical Analyzer - 25OH Vitamin D Assay; Thermo Fisher Scientific Inc, Cascadion SM Clinical Analyzer - Endocrinology; Thermo Fisher Scientific Inc, Cascadion SM Clinical Analyzer - Total Testosterone Assay; Tosoh Bioscience Inc, AIA-360 - Vitamin D Test; University of Edinburgh, Biomarker Diagnostic Test - Ectopic Pregnancy; University of Michigan, Molecular Diagnostic Test - Primary Aldosteronism; University of Otago, Biomarker-based Diagnostic Assay - Anti-Mullerian Hormone; University Rovira i Virgili, CD-Medics Test - Thyroiditis


Companies

Abbott Diagnostics

AgPlus Diagnostics LTD

Albert Einstein College of Medicine

Alere Inc

AMS Diagnostics LLC

Aura Biotechnologies Pvt Ltd

AXO Science SAS

Beckman Coulter Inc

Boditech Med Inc

Canon Medical Systems Corp

Carolina Liquid Chemistries Corp

Celmatix Inc

Ceres Nanosciences Inc

China Medical Technologies Inc

Columbia University

Denka Seiken Co Ltd

DiaSorin SpA

DIAsource ImmunoAssays SA

EDP Biotech Corporation

Ellume

Fujirebio Diagnostics Inc

GeneFluidics Inc

Genovum Sp. z o.o.

Hebrew University of Jerusalem

Immunodiagnostic Systems Holdings plc

Intermountain Healthcare Inc

King's College London

Laboratoire HRA Pharma SAS

Labsystems Diagnostics Oy

Lucine Biotechnology, Inc.

MDNA Life Sciences Inc

MedMira Inc

Mindray Medical International Ltd

MyHealthTest Pty Ltd

Northwestern University

Novartis AG

Oasis Diagnostics Corp

Ohmx Corp

OJ-Bio Ltd

Orangelife

Ortho-Clinical Diagnostics Inc

Otsuka Pharmaceutical Co Ltd

Paramedical Srl

PerkinElmer Inc

Proteomika

QuickCheck Health Inc

Quidel Corp

Roche Diagnostics International Ltd

Sendera Discovery

Shahid Beheshti University

Siemens Healthcare GmbH

SomaLogic Inc

Swan Diagnostics Ltd

Sysmex Corp

Tecan Group Ltd

Thermo Fisher Scientific Inc

Tosoh Bioscience Inc

University of Edinburgh

University of Michigan

University of Otago

University Rovira i Virgili

Endocrinology Tests-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Endocrinology Tests-Medical Devices Pipeline Assessment, 2018" provides an overview of Endocrinology 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 Endocrinology 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 Endocrinology 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 Endocrinology 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 Endocrinology 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.

READ MORE

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 14

2 Introduction 15

2.1 Endocrinology Tests Overview 15

3 Products under Development 16

3.1 Endocrinology Tests-Pipeline Products by Stage of Development 16

3.2 Endocrinology Tests-Pipeline Products by Segment 17

3.3 Endocrinology Tests-Pipeline Products by Territory 19

3.4 Endocrinology Tests-Pipeline Products by Regulatory Path 20

3.5 Endocrinology Tests-Pipeline Products by Estimated Approval Date 21

4 Endocrinology Tests-Pipeline Products under Development by Companies 22

4.1 Endocrinology Tests Companies-Pipeline Products by Stage of Development 22

4.2 Endocrinology Tests-Pipeline Products by Stage of Development 25

5 Endocrinology Tests Companies and Product Overview 31

5.1 Abbott Diagnostics Company Overview 31

5.2 AgPlus Diagnostics LTD Company Overview 33

5.3 Albert Einstein College of Medicine Company Overview 34

5.4 Alere Inc Company Overview 36

5.5 AMS Diagnostics LLC Company Overview 37

5.6 Aura Biotechnologies Pvt Ltd Company Overview 39

5.7 AXO Science SAS Company Overview 40

5.8 Beckman Coulter Inc Company Overview 41

5.9 Boditech Med Inc Company Overview 47

5.10 Canon Medical Systems Corp Company Overview 48

5.11 Carolina Liquid Chemistries Corp Company Overview 49

5.12 Celmatix Inc Company Overview 51

5.13 Ceres Nanosciences Inc Company Overview 52

5.14 China Medical Technologies Inc (Inactive) Company Overview 53

5.15 Columbia University Company Overview 54

5.16 Denka Seiken Co Ltd Company Overview 55

5.17 DiaSorin SpA Company Overview 56

5.18 DIAsource ImmunoAssays SA Company Overview 60

5.19 EDP Biotech Corporation Company Overview 61

5.20 Ellume Company Overview 62

5.21 Fujirebio Diagnostics Inc Company Overview 63

5.22 GeneFluidics Inc Company Overview 73

5.23 Genovum Sp. z o.o. Company Overview 76

5.24 Hebrew University of Jerusalem Company Overview 77

5.25 Immunodiagnostic Systems Holdings plc Company Overview 79

5.26 Intermountain Healthcare Inc Company Overview 84

5.27 King's College London Company Overview 85

5.28 Laboratoire HRA Pharma SAS Company Overview 86

5.29 Labsystems Diagnostics Oy Company Overview 87

5.30 Lucine Biotechnology, Inc. Company Overview 90

5.31 MDNA Life Sciences Inc Company Overview 91

5.32 MedMira Inc Company Overview 92

5.33 Mindray Medical International Ltd Company Overview 93

5.34 MyHealthTest Pty Ltd Company Overview 102

5.35 Northwestern University Company Overview 103

5.36 Novartis AG Company Overview 105

5.37 Oasis Diagnostics Corp Company Overview 107

5.38 Ohmx Corp Company Overview 108

5.39 OJ-Bio Ltd Company Overview 109

5.40 Orangelife Company Overview 110

5.41 Ortho-Clinical Diagnostics Inc Company Overview 111

5.42 Otsuka Pharmaceutical Co Ltd Company Overview 112

5.43 Paramedical Srl Company Overview 113

5.44 PerkinElmer Inc Company Overview 115

5.45 Proteomika Company Overview 116

5.46 QuickCheck Health Inc Company Overview 117

5.47 Quidel Corp Company Overview 118

5.48 Roche Diagnostics International Ltd Company Overview 120

5.49 Sendera Discovery Company Overview 133

5.50 Shahid Beheshti University Company Overview 134

5.51 Siemens Healthcare GmbH Company Overview 135

5.52 SomaLogic Inc Company Overview 155

5.53 Swan Diagnostics Ltd Company Overview 156

5.54 Sysmex Corp Company Overview 157

5.55 Tecan Group Ltd Company Overview 160

5.56 Thermo Fisher Scientific Inc Company Overview 162

5.57 Tosoh Bioscience Inc Company Overview 164

5.58 University of Edinburgh Company Overview 165

5.59 University of Michigan Company Overview 166

5.60 University of Otago Company Overview 167

5.61 University Rovira i Virgili Company Overview 168

6 Endocrinology Tests- Recent Developments 169

6.1 Jun 21, 2018: Sera Prognostics Appoints Dr. Garrett K. Lam as Chief Medical Officer 169

6.2 Jun 20, 2018: Immunodiagnostic Systems: Final Results for year ended 31 March 2018 170

6.3 Jun 19, 2018: Sera Prognostics Collaborates with Christiana Care Health System to Launch New Preterm Birth Study with PreTRM Test 174

6.4 Jun 13, 2018: Alfa Wassermann Diagnostic Technologies Honored for Delivering 'World-Class' Customer Service 175

6.5 Jun 12, 2018: Change at the top of the Segment Advanced Therapies at Siemens Healthineers 175

6.6 Jun 01, 2018: ISBT Satellite Symposium Co-hosted by Ortho Clinical Diagnostics and Quotient Discusses Responding to the Challenges of Resource Constraints in Transfusion Diagnostics 176

6.7 May 31, 2018: Aeterna Zentaris Appoints Olaf Althaus as General Manager and Managing Director of Aeterna Zentaris GmbH 177

6.8 May 29, 2018: Intermountain Healthcare Launches New Study to Determine Benefit of Proactive Interventions in Reducing Premature Births 177

6.9 May 16, 2018: Novartis announces changes to the Executive Committee 179

6.10 May 16, 2018: At the Meet Novartis Management investor event, Novartis highlights strategy to focus the company and drive sustainable growth 180

6.11 May 10, 2018: Novartis India reconstitutes Board appoints Milan Paleja as Vice Chairman Managing Director 181

6.12 May 09, 2018: Sysmex Group Formulates New Long-Term Management Goals 181

6.13 May 09, 2018: Sysmex Announces Summary of Consolidated Financial Results for the Fiscal Year Ended March 31, 2018 183

6.14 May 08, 2018: The Diasorin Group Reports Growth in Revenues and Profitability in the First Quarter 2018 186

6.15 May 08, 2018: Quidel Announces First Quarter 2018 Financial Results 189

6.16 May 08, 2018: Aeterna Zentaris Announces Results of Annual and Special Shareholders' Meeting 190

6.17 May 08, 2018: Ortho Clinical Diagnostics Holds Summit to Help Asia-Pacific Lab Leaders Envision the Lab of the Future 191

6.18 May 07, 2018: Luminex Announces First Quarter 2018 Financial Results 192

6.19 May 07, 2018: Aeterna Zentaris Reports First Quarter 2018 Financial and Operating Results 192

6.20 May 03, 2018: Siemens Healthineers fully on track to meet the targets 194

6.21 May 02, 2018: Novo Nordisk's operating profit decreased by 8% in Danish kroner and increased by 6% in local currencies in the first three months of 2018 195

6.22 May 01, 2018: Veracyte Reports First Quarter 2018 Financial Results 196

7 Appendix 329

7.1 Methodology 329

7.2 About GlobalData 332

7.3 Contact Us 332

7.4 Disclaimer 332


List Of Figure

1.2 List of Figures

Figure 1: Endocrinology Tests-Pipeline Products by Stage of Development 18

Figure 2: Endocrinology Tests-Pipeline Products by Segment 19

Figure 3: Endocrinology Tests-Pipeline Products by Territory 21

Figure 4: Endocrinology Tests-Pipeline Products by Regulatory Path 22

Figure 5: Endocrinology Tests-Pipeline Products by Estimated Approval Date 23


List Of Table

1.1 List of Tables

Table 1: Endocrinology Tests-Pipeline Products by Stage of Development 18

Table 2: Endocrinology Tests-Pipeline Products by Segment 19

Table 3: Endocrinology Tests-Pipeline Products by Territory 21

Table 4: Endocrinology Tests-Pipeline Products by Regulatory Path 22

Table 5: Endocrinology Tests-Pipeline Products by Estimated Approval Date 23

Table 6: Endocrinology Tests Companies-Pipeline Products by Stage of Development 24

Table 7: Endocrinology Tests-Pipeline Products by Stage of Development 27

Table 8: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 33

Table 9: Alinity ci-Hormone Deficiency-Product Status 33

Table 10: Alinity ci-Hormone Deficiency-Product Description 33

Table 11: Alinity ci-Thyroid Disease-Product Status 34

Table 12: Alinity ci-Thyroid Disease-Product Description 34

Table 13: AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 35

Table 14: AgPlus Diagnostic System-Testosterone Assay-Product Status 35

Table 15: AgPlus Diagnostic System-Testosterone Assay-Product Description 35

Table 16: Albert Einstein College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 36

Table 17: Cortisol Assay-Product Status 36

Table 18: Cortisol Assay-Product Description 36

Table 19: Estradiol Assay-Product Status 37

Table 20: Estradiol Assay-Product Description 37

Table 21: Progesterone Assay-Product Status 37

Table 22: Progesterone Assay-Product Description 37

Table 23: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 24: Vitamin D Assay-Product Status 38

Table 25: Vitamin D Assay-Product Description 38

Table 26: AMS Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 39

Table 27: LIASYS 330-Vitamin D Assay-Product Status 39

Table 28: LIASYS 330-Vitamin D Assay-Product Description 39

Table 29: Liasys 450-Vitamin D Assay-Product Status 39

Table 30: Liasys 450-Vitamin D Assay-Product Description 40

Table 31: Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

Table 32: AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit-Product Status 41

Table 33: AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit-Product Description 41

Table 34: AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 42

Table 35: Multiplexed Detection-TSH-Product Status 42

Table 36: Multiplexed Detection-TSH-Product Description 42

Table 37: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 38: Access 2 Immunoassay System-Sensitive Estradiol-Product Status 43

Table 39: Access 2 Immunoassay System-Sensitive Estradiol-Product Description 44

Table 40: UniCel DxC 660i Synchron Access Clinical System-AMH Assay-Product Status 44

Table 41: UniCel DxC 660i Synchron Access Clinical System-AMH Assay-Product Description 44

Table 42: UniCel DxI 600 Access Immunoassay System-AMH Assay-Product Status 44

Table 43: UniCel DxI 600 Access Immunoassay System-AMH Assay-Product Description 45

Table 44: UniCel DxI 600 Access Immunoassay System-Sensitive Estradiol Assay-Product Status 45

Table 45: UniCel DxI 600 Access Immunoassay System-Sensitive Estradiol Assay-Product Description 45

Table 46: UniCel DxI 600 Access Immunoassay System-TSH (3rd IS) Assay-Product Status 45

Table 47: UniCel DxI 600 Access Immunoassay System-TSH (3rd IS) Assay-Product Description 46

Table 48: UniCel DxI 800 Access Immunoassay System-AMH Assay-Product Status 46

Table 49: UniCel DxI 800 Access Immunoassay System-AMH Assay-Product Description 46

Table 50: UniCel DxI 800 Access Immunoassay System-Sensitive Estradiol Assay-Product Status 46

Table 51: UniCel DxI 800 Access Immunoassay System-Sensitive Estradiol Assay-Product Description 47

Table 52: UniCel DxI 800 Access Immunoassay System-TSH (3rd IS) Assay-Product Status 47

Table 53: UniCel DxI 800 Access Immunoassay System-TSH (3rd IS) Assay-Product Description 47

Table 54: UniCel DxI 860i Synchron Access Clinical System-Vitamin D Assay-Product Status 47

Table 55: UniCel DxI 860i Synchron Access Clinical System-Vitamin D Assay-Product Description 48

Table 56: Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 49

Table 57: AFIAS-6 Progesterone Assay-Product Status 49

Table 58: AFIAS-6 Progesterone Assay-Product Description 49

Table 59: Canon Medical Systems Corp Pipeline Products & Ongoing Clinical Trials Overview 50

Table 60: Diagnostic Test-Thyroid Disorders-Product Status 50

Table 61: Diagnostic Test-Thyroid Disorders-Product Description 50

Table 62: Carolina Liquid Chemistries Corp Pipeline Products & Ongoing Clinical Trials Overview 51

Table 63: CLC 480 Analyzer-Vitamin D Assay-Product Status 51

Table 64: CLC 480 Analyzer-Vitamin D Assay-Product Description 51

Table 65: CLC 720i Analyzer-Vitamin D Assay-Product Status 52

Table 66: CLC 720i Analyzer-Vitamin D Assay-Product Description 52

Table 67: Celmatix Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Table 68: FertilArray-Product Status 53

Table 69: FertilArray-Product Description 53

Table 70: Ceres Nanosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Table 71: Nanotrap Human Growth Hormone Test-Product Status 54

Table 72: Nanotrap Human Growth Hormone Test-Product Description 54

Table 73: China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 55

Table 74: Infertility Reagent Test kit-ECLIA Analyzer-Product Status 55

Table 75: Infertility Reagent Test kit-ECLIA Analyzer-Product Description 55

Table 76: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 56

Table 77: Diagnostic Test-Menopause-Product Status 56

Table 78: Diagnostic Test-Menopause-Product Description 56

Table 79: Denka Seiken Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Table 80: Adiponectin Assay Kit-Product Status 57

Table 81: Adiponectin Assay Kit-Product Description 57

Table 82: DiaSorin SpA Pipeline Products & Ongoing Clinical Trials Overview 58

Table 83: Estradiol II Assay-Product Status 58

Table 84: Estradiol II Assay-Product Description 58

Table 85: LIAISON-High Sclerostin Assay-Product Status 59

Table 86: LIAISON-High Sclerostin Assay-Product Description 59

Table 87: LIAISON-Hyperphosphate Low Bone Turnover Assay-Product Status 59

Table 88: LIAISON-Hyperphosphate Low Bone Turnover Assay-Product Description 60

Table 89: LIAISON XL-Sclerostin Assay-Product Status 60

Table 90: LIAISON XL-Sclerostin Assay-Product Description 60

Table 91: Progesterone II Assay-Product Status 61

Table 92: Progesterone II Assay-Product Description 61

Table 93: DIAsource ImmunoAssays SA Pipeline Products & Ongoing Clinical Trials Overview 62

Table 94: 25-OH Vitamin D Total ELISA Test-Product Status 62

Table 95: 25-OH Vitamin D Total ELISA Test-Product Description 62

Table 96: EDP Biotech Corporation Pipeline Products & Ongoing Clinical Trials Overview 63

Table 97: Diagnostic Assay-Early Conception Factor-Product Status 63

Table 98: Diagnostic Assay-Early Conception Factor-Product Description 63

Table 99: Ellume Pipeline Products & Ongoing Clinical Trials Overview 64

Table 100: ESP-Based Diagnostic Test-Pregnancy-Product Status 64

Table 101: ESP-Based Diagnostic Test-Pregnancy-Product Description 64

Table 102: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 65

Table 103: Lumipulse G-AFP Assay-Product Status 65

Table 104: Lumipulse G-AFP Assay-Product Description 66

Table 105: Lumipulse G-FT3 Assay-Product Status 66

Table 106: Lumipulse G-FT3 Assay-Product Description 66

Table 107: Lumipulse G-FT4 Assay-Product Status 67

Table 108: Lumipulse G-FT4 Assay-Product Description 67

Table 109: Lumipulse G-T3 Assay-Product Status 67

Table 110: Lumipulse G-T3 Assay-Product Description 68

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Products

Abbott Diagnostics, Alinity ci - Hormone Deficiency; Abbott Diagnostics, Alinity ci - Thyroid Disease; AgPlus Diagnostics LTD, AgPlus Diagnostic System - Testosterone Assay; Albert Einstein College of Medicine, Cortisol Assay; Albert Einstein College of Medicine, Estradiol Assay; Albert Einstein College of Medicine, Progesterone Assay; Alere Inc, Vitamin D Assay; AMS Diagnostics LLC, LIASYS 330 - Vitamin D Assay; AMS Diagnostics LLC, Liasys 450 - Vitamin D Assay; Aura Biotechnologies Pvt Ltd, AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit; AXO Science SAS, Multiplexed Detection - TSH; Beckman Coulter Inc, Access 2 Immunoassay System - Sensitive Estradiol; Beckman Coulter Inc, UniCel DxC 660i Synchron Access Clinical System - AMH Assay; Beckman Coulter Inc, UniCel DxI 600 Access Immunoassay System - AMH Assay; Beckman Coulter Inc, UniCel DxI 600 Access Immunoassay System - Sensitive Estradiol Assay; Beckman Coulter Inc, UniCel DxI 600 Access Immunoassay System - TSH (3rd IS) Assay; Beckman Coulter Inc, UniCel DxI 800 Access Immunoassay System - AMH Assay; Beckman Coulter Inc, UniCel DxI 800 Access Immunoassay System - Sensitive Estradiol Assay; Beckman Coulter Inc, UniCel DxI 800 Access Immunoassay System - TSH (3rd IS) Assay; Beckman Coulter Inc, UniCel DxI 860i Synchron Access Clinical System - Vitamin D Assay; Boditech Med Inc, AFIAS-6 Progesterone Assay; Canon Medical Systems Corp, Diagnostic Test - Thyroid Disorders; Carolina Liquid Chemistries Corp, CLC 480 Analyzer - Vitamin D Assay; Carolina Liquid Chemistries Corp, CLC 720i Analyzer - Vitamin D Assay; Celmatix Inc, FertilArray; Ceres Nanosciences Inc, Nanotrap Human Growth Hormone Test; China Medical Technologies Inc (Inactive), Infertility Reagent Test kit - ECLIA Analyzer; Columbia University, Diagnostic Test - Menopause; Denka Seiken Co Ltd, Adiponectin Assay Kit; DiaSorin SpA, Estradiol II Assay; DiaSorin SpA, LIAISON - High Sclerostin Assay; DiaSorin SpA, LIAISON - Hyperphosphate Low Bone Turnover Assay; DiaSorin SpA, LIAISON XL - Sclerostin Assay; DiaSorin SpA, Progesterone II Assay; DIAsource ImmunoAssays SA, 25-OH Vitamin D Total ELISA Test; EDP Biotech Corporation, Diagnostic Assay - Early Conception Factor; Ellume, ESP-Based Diagnostic Test - Pregnancy; Fujirebio Diagnostics Inc, Lumipulse G - AFP Assay; Fujirebio Diagnostics Inc, Lumipulse G - FT3 Assay; Fujirebio Diagnostics Inc, Lumipulse G - FT4 Assay; Fujirebio Diagnostics Inc, Lumipulse G - T3 Assay; Fujirebio Diagnostics Inc, Lumipulse G - T4 Assay; Fujirebio Diagnostics Inc, Lumipulse G - TgAb Assay; Fujirebio Diagnostics Inc, Lumipulse G - TPOAb Assay; Fujirebio Diagnostics Inc, Lumipulse G1200 - AMH; Fujirebio Diagnostics Inc, Lumipulse G1200 - Estradiol Assay; Fujirebio Diagnostics Inc, Lumipulse G1200 - FSH Test; Fujirebio Diagnostics Inc, Lumipulse G1200 - Progestrone Test; Fujirebio Diagnostics Inc, Lumipulse G1200 - Testosterone Assay; Fujirebio Diagnostics Inc, Lumipulse G1200 - Total -HCG Assay; Fujirebio Diagnostics Inc, Lumipulse G1200 - Whole PTH; GeneFluidics Inc, Free T3 Assay; GeneFluidics Inc, Free T4 Assay; GeneFluidics Inc, T3 Assay; GeneFluidics Inc, T4 Assay; Genovum Sp. z o.o., Diagnostic Test - Polycystic Ovarian Syndrome; Hebrew University of Jerusalem, Diagnostic Assay - Ovulation; Hebrew University of Jerusalem, Diagnostic Assay - Pregnancy; Immunodiagnostic Systems Holdings plc, IDS-iSYS - 17-beta Estradiol Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS - Total Testosterone Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS Bioactive PTH (1-84) Kit; Immunodiagnostic Systems Holdings plc, IDS-iSYS Cortisol Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS Free Testosterone Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS Intact PINP Assay; Immunodiagnostic Systems Holdings plc, IDS-iSYS MGP Assay; Intermountain Healthcare Inc, Cortisol Assay; King's College London, Elafin Test - Preterm Birth; Laboratoire HRA Pharma SAS, Indigo; Labsystems Diagnostics Oy, Enzymatic Immuno Assay - Neonatal hTSH EIA; Labsystems Diagnostics Oy, Enzymatic Immuno Assay - Neonatal hTSH FEIA Plus; Labsystems Diagnostics Oy, Fluoro Enzymatic Immuno Assay - Neonatal 17-OH-Progesterone FEIA; Labsystems Diagnostics Oy, TSH Point Of Birth; Lucine Biotechnology, Inc., Salivary Diagnostic Test - PCOS; MDNA Life Sciences Inc, Diagnostic Assay - Endocrinology; MedMira Inc, Reveal TSH Single Test; Mindray Medical International Ltd, CL-1000i - Calcitonin Test; Mindray Medical International Ltd, CL-1000i - Intact PTH Test; Mindray Medical International Ltd, CL-1000i - Vitamin D Total Test; Mindray Medical International Ltd, CL-2000i - ACTH Test; Mindray Medical International Ltd, CL-2000i - Anti-TG Test; Mindray Medical International Ltd, CL-2000i - Anti-TPO; Mindray Medical International Ltd, CL-2000i - Calcitonin Test; Mindray Medical International Ltd, CL-2000i - Cortisol Test; Mindray Medical International Ltd, CL-2000i - DHEA-S Test; Mindray Medical International Ltd, CL-2000i - PTH Test; Mindray Medical International Ltd, CL-2000i - Thyroglobulin (TG) Test; Mindray Medical International Ltd, CL-2000i - Vitamin D Total Test; MyHealthTest Pty Ltd, Diagnostic Test - Hormones; Northwestern University, At Home Menopause Test; Northwestern University, Female Fertility Test; Novartis AG, Diagnostic Test - Thyroid Stimulating Hormone; Novartis AG, Rapid Diagnostic Test - Vitamin D; Oasis Diagnostics Corp, VerOFy Salivary Based Test - Estradiol; Ohmx Corp, Portable POC System - Thyroid Stimulating Hormone; OJ-Bio Ltd, Parathyroid Hormone Assay; Orangelife, Pregnancy Kit; Ortho-Clinical Diagnostics Inc, Diagnostic Assay - Thyroid Diseases; Otsuka Pharmaceutical Co Ltd, ODK-1403; Paramedical Srl, PKL PPC 960 - AMH; Paramedical Srl, PKL PPC 960 - Inhibin A; Paramedical Srl, PKL PPC 960 - TRAb; PerkinElmer Inc, Diagnostic Test - Preterm Birth; Proteomika, Proimplant; QuickCheck Health Inc, Diagnostic Test - Pregnancy; Quidel Corp, Dual Block/Stim Assay; Quidel Corp, Thyretain TBI Reporter BioAssay; Roche Diagnostics International Ltd, Cobas 4000 Analyzer Series With e 411 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 6000 Analyzer Series With c 501 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 6000 Analyzer Series With c 501 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 6000 Analyzer Series With e 601 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 6000 Analyzer Series With e 601 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 502 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 502 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 701 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 701 Module - IGF-1; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With c 702 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 602 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 602 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 801 Module - 17-OH-Progesterone Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 801 Module - Androstenedione Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 801 Module - IGF BP3 Assay; Roche Diagnostics International Ltd, Cobas 8000 Analyzer Series With e 801 Module - IGF-1 Assay; Roche Diagnostics International Ltd, Diagnostic Assay - AMH; Roche Diagnostics International Ltd, Diagnostic Test - IGFBP3; Roche Diagnostics International Ltd, Integrated Modular Analytics system - PAPP-A Test; Sendera Discovery, In-Vitro Diagnostic Kit - Androgen Replacement Therapy; Shahid Beheshti University, Prognostic Test - Menopause; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - Anti-Mullerian Hormone Assay; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - Free hCG Assay; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - PAPP-A Assay; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - Tg Assay; Siemens Healthcare GmbH, ADVIA Centaur CP Immunoassay System - Vitamin D Assay; Siemens Healthcare GmbH, ADVIA Centaur XP Immunoassay System - Anti-Mullerian Hormone Assay; Siemens Healthcare GmbH, ADVIA Centaur XP Immunoassay System - Free hCG Assay; Siemens Healthcare GmbH, ADVIA Centaur XP Immunoassay System - PAPP-A Assay; Siemens Healthcare GmbH, ADVIA Centaur XP Immunoassay System - Tg Assay; Siemens Healthcare GmbH, ADVIA Centaur XPT Immunoassay System - Anti-Mullerian Hormone Assay; Siemens Healthcare GmbH, ADVIA Centaur XPT Immunoassay System - Free hCG Assay; Siemens Healthcare GmbH, ADVIA Centaur XPT Immunoassay System - PAPP-A Assay; Siemens Healthcare GmbH, ADVIA Centaur XPT Immunoassay System - Tg Assay; Siemens Healthcare GmbH, Dimension EXL 200 Integrated Chemistry System - LOCI IPTH; Siemens Healthcare GmbH, Dimension EXL 200 Integrated Chemistry System - Vitamin D Assay; Siemens Healthcare GmbH, Dimension EXL with LM Integrated Chemistry System - LOCI Cortisol Assay; Siemens Healthcare GmbH, Dimension EXL with LM Integrated Chemistry System - LOCI IPTH Assay; Siemens Healthcare GmbH, Dimension EXL with LM Integrated Chemistry System - LOCI Vitamin D Assay; Siemens Healthcare GmbH, Dimension EXL With LM Integrated Chemistry System - Vitamin D Assay; Siemens Healthcare GmbH, Dimension Vista 1000T Intelligent Lab System - Cortisol Assay; Siemens Healthcare GmbH, Dimension Vista 1000T Intelligent Lab System - Testosterone Assay; Siemens Healthcare GmbH, Dimension Vista 1500 Intelligent Lab System - Loci Vitamin D Assay; Siemens Healthcare GmbH, Dimension Vista 1500 Intelligent Lab System - Intact PTH Assay; Siemens Healthcare GmbH, Dimension Vista 3000T Intelligent Lab System - Cortisol Assay; Siemens Healthcare GmbH, Dimension Vista 3000T Intelligent Lab System - Testosterone Assay; Siemens Healthcare GmbH, Dimension Vista 500 Intelligent Lab System - Cortisol Assay; Siemens Healthcare GmbH, Dimension Vista 500 Intelligent Lab System - Intact PTH Assay; Siemens Healthcare GmbH, Dimension Vista 500 Intelligent Lab System - Testosterone Assay; Siemens Healthcare GmbH, IMMULITE 1000 Immunoassay System - PAPP-A Assay; Siemens Healthcare GmbH, IMMULITE 1000 Immunoassay System - Free Beta HCG Assay; Siemens Healthcare GmbH, IMMULITE 1000 Immunoassay System - TSI Assay; Siemens Healthcare GmbH, IMMULITE 2000 XPi Immunoassay System - Free Beta HCG Assay; SomaLogic Inc, SOMAscan Assay - Preterm Labor; Swan Diagnostics Ltd, FertiGO; Sysmex Corp, Immunochemistry Test - FSH; Sysmex Corp, Immunochemistry Test - LH; Sysmex Corp, Immunochemistry Test - Tg Ab; Sysmex Corp, Immunochemistry Test - TPO Ab; Sysmex Corp, Immunochemistry Test - TR Ab; Tecan Group Ltd, 17-OH-Progesterone Neonatal Screening Assay; Tecan Group Ltd, Neonatal Screening Assay - Congenital Hypothyroidism; Thermo Fisher Scientific Inc, Cascadion SM Clinical Analyzer - 25OH Vitamin D Assay; Thermo Fisher Scientific Inc, Cascadion SM Clinical Analyzer - Endocrinology; Thermo Fisher Scientific Inc, Cascadion SM Clinical Analyzer - Total Testosterone Assay; Tosoh Bioscience Inc, AIA-360 - Vitamin D Test; University of Edinburgh, Biomarker Diagnostic Test - Ectopic Pregnancy; University of Michigan, Molecular Diagnostic Test - Primary Aldosteronism; University of Otago, Biomarker-based Diagnostic Assay - Anti-Mullerian Hormone; University Rovira i Virgili, CD-Medics Test - Thyroiditis


Companies

Abbott Diagnostics

AgPlus Diagnostics LTD

Albert Einstein College of Medicine

Alere Inc

AMS Diagnostics LLC

Aura Biotechnologies Pvt Ltd

AXO Science SAS

Beckman Coulter Inc

Boditech Med Inc

Canon Medical Systems Corp

Carolina Liquid Chemistries Corp

Celmatix Inc

Ceres Nanosciences Inc

China Medical Technologies Inc

Columbia University

Denka Seiken Co Ltd

DiaSorin SpA

DIAsource ImmunoAssays SA

EDP Biotech Corporation

Ellume

Fujirebio Diagnostics Inc

GeneFluidics Inc

Genovum Sp. z o.o.

Hebrew University of Jerusalem

Immunodiagnostic Systems Holdings plc

Intermountain Healthcare Inc

King's College London

Laboratoire HRA Pharma SAS

Labsystems Diagnostics Oy

Lucine Biotechnology, Inc.

MDNA Life Sciences Inc

MedMira Inc

Mindray Medical International Ltd

MyHealthTest Pty Ltd

Northwestern University

Novartis AG

Oasis Diagnostics Corp

Ohmx Corp

OJ-Bio Ltd

Orangelife

Ortho-Clinical Diagnostics Inc

Otsuka Pharmaceutical Co Ltd

Paramedical Srl

PerkinElmer Inc

Proteomika

QuickCheck Health Inc

Quidel Corp

Roche Diagnostics International Ltd

Sendera Discovery

Shahid Beheshti University

Siemens Healthcare GmbH

SomaLogic Inc

Swan Diagnostics Ltd

Sysmex Corp

Tecan Group Ltd

Thermo Fisher Scientific Inc

Tosoh Bioscience Inc

University of Edinburgh

University of Michigan

University of Otago

University Rovira i Virgili