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Reproductive Hormones and Proteins Tests - Medical Devices Pipeline Assessment, 2018

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Details

Reproductive Hormones and Proteins Tests-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Reproductive Hormones and Proteins Tests-Medical Devices Pipeline Assessment, 2018" provides an overview of Reproductive Hormones and Proteins 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 Reproductive Hormones and Proteins 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 Reproductive Hormones and Proteins 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 Reproductive Hormones and Proteins 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 Reproductive Hormones and Proteins 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 5

1.2 List of Figures 8

2 Introduction 9

2.1 Reproductive Hormones and Proteins Tests Overview 9

3 Products under Development 10

3.1 Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 10

3.2 Reproductive Hormones and Proteins Tests-Pipeline Products by Segment 11

3.3 Reproductive Hormones and Proteins Tests-Pipeline Products by Territory 12

3.4 Reproductive Hormones and Proteins Tests-Pipeline Products by Regulatory Path 13

3.5 Reproductive Hormones and Proteins Tests-Pipeline Products by Estimated Approval Date 14

4 Reproductive Hormones and Proteins Tests-Pipeline Products under Development by Companies 15

4.1 Reproductive Hormones and Proteins Tests Companies-Pipeline Products by Stage of Development 15

4.2 Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 17

5 Reproductive Hormones and Proteins Tests Companies and Product Overview 20

5.1 AgPlus Diagnostics LTD Company Overview 20

5.2 Albert Einstein College of Medicine Company Overview 21

5.3 Aura Biotechnologies Pvt Ltd Company Overview 22

5.4 Beckman Coulter Inc Company Overview 23

5.5 Boditech Med Inc Company Overview 27

5.6 China Medical Technologies Inc (Inactive) Company Overview 28

5.7 DiaSorin SpA Company Overview 29

5.8 Ellume Company Overview 31

5.9 Fujirebio Diagnostics Inc Company Overview 32

5.10 Genovum Sp. z o.o. Company Overview 37

5.11 Hebrew University of Jerusalem Company Overview 38

5.12 Immunodiagnostic Systems Holdings plc Company Overview 40

5.13 King's College London Company Overview 43

5.14 Labsystems Diagnostics Oy Company Overview 44

5.15 Lucine Biotechnology, Inc. Company Overview 45

5.16 Mindray Medical International Ltd Company Overview 46

5.17 Northwestern University Company Overview 47

5.18 Oasis Diagnostics Corp Company Overview 49

5.19 Orangelife Company Overview 50

5.20 Paramedical Srl Company Overview 51

5.21 PerkinElmer Inc Company Overview 53

5.22 Proteomika Company Overview 54

5.23 QuickCheck Health Inc Company Overview 55

5.24 Roche Diagnostics International Ltd Company Overview 56

5.25 Shahid Beheshti University Company Overview 59

5.26 Siemens Healthcare GmbH Company Overview 60

5.27 SomaLogic Inc Company Overview 71

5.28 Swan Diagnostics Ltd Company Overview 72

5.29 Sysmex Corp Company Overview 73

5.30 Tecan Group Ltd Company Overview 75

5.31 Thermo Fisher Scientific Inc Company Overview 76

5.32 University of Edinburgh Company Overview 77

5.33 University of Otago Company Overview 78

6 Reproductive Hormones and Proteins Tests- Recent Developments 79

6.1 Jun 21, 2018: Sera Prognostics Appoints Dr. Garrett K. Lam as Chief Medical Officer 79

6.2 Jun 20, 2018: Immunodiagnostic Systems: Final Results for year ended 31 March 2018 80

6.3 Jun 19, 2018: Sera Prognostics Collaborates with Christiana Care Health System to Launch New Preterm Birth Study with PreTRM Test 84

6.4 Jun 12, 2018: Change at the top of the Segment Advanced Therapies at Siemens Healthineers 85

6.5 Jun 07, 2018: Blood test may identify pregnant women at risk of premature birth 85

7 Appendix 171

7.1 Methodology 171

7.2 About GlobalData 174

7.3 Contact Us 174

7.4 Disclaimer 174


List Of Figure

1.2 List of Figures

Figure 1: Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 11

Figure 2: Reproductive Hormones and Proteins Tests-Pipeline Products by Segment 12

Figure 3: Reproductive Hormones and Proteins Tests-Pipeline Products by Territory 13

Figure 4: Reproductive Hormones and Proteins Tests-Pipeline Products by Regulatory Path 14

Figure 5: Reproductive Hormones and Proteins Tests-Pipeline Products by Estimated Approval Date 15


List Of Table

1.1 List of Tables

Table 1: Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 11

Table 2: Reproductive Hormones and Proteins Tests-Pipeline Products by Segment 12

Table 3: Reproductive Hormones and Proteins Tests-Pipeline Products by Territory 13

Table 4: Reproductive Hormones and Proteins Tests-Pipeline Products by Regulatory Path 14

Table 5: Reproductive Hormones and Proteins Tests-Pipeline Products by Estimated Approval Date 15

Table 6: Reproductive Hormones and Proteins Tests Companies-Pipeline Products by Stage of Development 16

Table 7: Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 18

Table 8: AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 21

Table 9: AgPlus Diagnostic System-Testosterone Assay-Product Status 21

Table 10: AgPlus Diagnostic System-Testosterone Assay-Product Description 21

Table 11: Albert Einstein College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 22

Table 12: Estradiol Assay-Product Status 22

Table 13: Estradiol Assay-Product Description 22

Table 14: Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Table 15: AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit-Product Status 23

Table 16: AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit-Product Description 23

Table 17: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Table 18: Access 2 Immunoassay System-Sensitive Estradiol-Product Status 24

Table 19: Access 2 Immunoassay System-Sensitive Estradiol-Product Description 24

Table 20: UniCel DxC 660i Synchron Access Clinical System-AMH Assay-Product Status 25

Table 21: UniCel DxC 660i Synchron Access Clinical System-AMH Assay-Product Description 25

Table 22: UniCel DxI 600 Access Immunoassay System-AMH Assay-Product Status 25

Table 23: UniCel DxI 600 Access Immunoassay System-AMH Assay-Product Description 25

Table 24: UniCel DxI 600 Access Immunoassay System-Sensitive Estradiol Assay-Product Status 26

Table 25: UniCel DxI 600 Access Immunoassay System-Sensitive Estradiol Assay-Product Description 26

Table 26: UniCel DxI 800 Access Immunoassay System-AMH Assay-Product Status 26

Table 27: UniCel DxI 800 Access Immunoassay System-AMH Assay-Product Description 26

Table 28: UniCel DxI 800 Access Immunoassay System-Sensitive Estradiol Assay-Product Status 27

Table 29: UniCel DxI 800 Access Immunoassay System-Sensitive Estradiol Assay-Product Description 27

Table 30: Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Table 31: AFIAS-6 Progesterone Assay-Product Status 28

Table 32: AFIAS-6 Progesterone Assay-Product Description 28

Table 33: China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 29

Table 34: Infertility Reagent Test kit-ECLIA Analyzer-Product Status 29

Table 35: Infertility Reagent Test kit-ECLIA Analyzer-Product Description 29

Table 36: DiaSorin SpA Pipeline Products & Ongoing Clinical Trials Overview 30

Table 37: Estradiol II Assay-Product Status 30

Table 38: Estradiol II Assay-Product Description 30

Table 39: Progesterone II Assay-Product Status 31

Table 40: Progesterone II Assay-Product Description 31

Table 41: Ellume Pipeline Products & Ongoing Clinical Trials Overview 32

Table 42: ESP-Based Diagnostic Test-Pregnancy-Product Status 32

Table 43: ESP-Based Diagnostic Test-Pregnancy-Product Description 32

Table 44: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Table 45: Lumipulse G-AFP Assay-Product Status 33

Table 46: Lumipulse G-AFP Assay-Product Description 33

Table 47: Lumipulse G1200-AMH-Product Status 34

Table 48: Lumipulse G1200-AMH-Product Description 34

Table 49: Lumipulse G1200-Estradiol Assay-Product Status 34

Table 50: Lumipulse G1200-Estradiol Assay-Product Description 35

Table 51: Lumipulse G1200-FSH Test-Product Status 35

Table 52: Lumipulse G1200-FSH Test-Product Description 35

Table 53: Lumipulse G1200-Progestrone Test-Product Status 36

Table 54: Lumipulse G1200-Progestrone Test-Product Description 36

Table 55: Lumipulse G1200-Testosterone Assay-Product Status 36

Table 56: Lumipulse G1200-Testosterone Assay-Product Description 36

Table 57: Lumipulse G1200-Total -HCG Assay-Product Status 37

Table 58: Lumipulse G1200-Total -HCG Assay-Product Description 37

Table 59: Genovum Sp. z o.o. Pipeline Products & Ongoing Clinical Trials Overview 38

Table 60: Diagnostic Test-Polycystic Ovarian Syndrome-Product Status 38

Table 61: Diagnostic Test-Polycystic Ovarian Syndrome-Product Description 38

Table 62: Hebrew University of Jerusalem Pipeline Products & Ongoing Clinical Trials Overview 39

Table 63: Diagnostic Assay-Ovulation-Product Status 39

Table 64: Diagnostic Assay-Ovulation-Product Description 39

Table 65: Diagnostic Assay-Pregnancy-Product Status 40

Table 66: Diagnostic Assay-Pregnancy-Product Description 40

Table 67: Immunodiagnostic Systems Holdings plc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 68: IDS-iSYS-17-beta Estradiol Assay-Product Status 41

Table 69: IDS-iSYS-17-beta Estradiol Assay-Product Description 41

Table 70: IDS-iSYS-Total Testosterone Assay-Product Status 42

Table 71: IDS-iSYS-Total Testosterone Assay-Product Description 42

Table 72: IDS-iSYS Free Testosterone Assay-Product Status 42

Table 73: IDS-iSYS Free Testosterone Assay-Product Description 43

Table 74: King's College London Pipeline Products & Ongoing Clinical Trials Overview 44

Table 75: Elafin Test-Preterm Birth-Product Status 44

Table 76: Elafin Test-Preterm Birth-Product Description 44

Table 77: Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 45

Table 78: Fluoro Enzymatic Immuno Assay-Neonatal 17-OH-Progesterone FEIA-Product Status 45

Table 79: Fluoro Enzymatic Immuno Assay-Neonatal 17-OH-Progesterone FEIA-Product Description 45

Table 80: Lucine Biotechnology, Inc. Pipeline Products & Ongoing Clinical Trials Overview 46

Table 81: Salivary Diagnostic Test-PCOS-Product Status 46

Table 82: Salivary Diagnostic Test-PCOS-Product Description 46

Table 83: Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

Table 84: CL-2000i-DHEA-S Test-Product Status 47

Table 85: CL-2000i-DHEA-S Test-Product Description 47

Table 86: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 48

Table 87: At Home Menopause Test-Product Status 48

Table 88: At Home Menopause Test-Product Description 48

Table 89: Female Fertility Test-Product Status 49

Table 90: Female Fertility Test-Product Description 49

Table 91: Oasis Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 50

Table 92: VerOFy Salivary Based Test-Estradiol-Product Status 50

Table 93: VerOFy Salivary Based Test-Estradiol-Product Description 50

Table 94: Orangelife Pipeline Products & Ongoing Clinical Trials Overview 51

Table 95: Pregnancy Kit-Product Status 51

Table 96: Pregnancy Kit-Product Description 51

Table 97: Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 52

Table 98: PKL PPC 960-AMH-Product Status 52

Table 99: PKL PPC 960-AMH-Product Description 52

Table 100: PKL PPC 960-Inhibin A-Product Status 53

Table 101: PKL PPC 960-Inhibin A-Product Description 53

Table 102: PerkinElmer Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Table 103: Diagnostic Test-Preterm Birth-Product Status 54

Table 104: Diagnostic Test-Preterm Birth-Product Description 54

Table 105: Proteomika Pipeline Products & Ongoing Clinical Trials Overview 55

Table 106: Proimplant-Product Status 55

Table 107: Proimplant-Product Description 55

Table 108: QuickCheck Health Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 109: Diagnostic Test-Pregnancy-Product Status 56

Licence Rights

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Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

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Products and Companies

Products

AgPlus Diagnostics LTD, AgPlus Diagnostic System - Testosterone Assay; Albert Einstein College of Medicine, Estradiol Assay; Aura Biotechnologies Pvt Ltd, AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit; 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 800 Access Immunoassay System - AMH Assay; Beckman Coulter Inc, UniCel DxI 800 Access Immunoassay System - Sensitive Estradiol Assay; Boditech Med Inc, AFIAS-6 Progesterone Assay; China Medical Technologies Inc (Inactive), Infertility Reagent Test kit - ECLIA Analyzer; DiaSorin SpA, Estradiol II Assay; DiaSorin SpA, Progesterone II Assay; Ellume, ESP-Based Diagnostic Test - Pregnancy; Fujirebio Diagnostics Inc, Lumipulse G - AFP 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; 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 Free Testosterone Assay; King's College London, Elafin Test - Preterm Birth; Labsystems Diagnostics Oy, Fluoro Enzymatic Immuno Assay - Neonatal 17-OH-Progesterone FEIA; Lucine Biotechnology, Inc., Salivary Diagnostic Test - PCOS; Mindray Medical International Ltd, CL-2000i - DHEA-S Test; Northwestern University, At Home Menopause Test; Northwestern University, Female Fertility Test; Oasis Diagnostics Corp, VerOFy Salivary Based Test - Estradiol; Orangelife, Pregnancy Kit; Paramedical Srl, PKL PPC 960 - AMH; Paramedical Srl, PKL PPC 960 - Inhibin A; PerkinElmer Inc, Diagnostic Test - Preterm Birth; Proteomika, Proimplant; QuickCheck Health Inc, Diagnostic Test - Pregnancy; 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, Diagnostic Assay - AMH; Roche Diagnostics International Ltd, Integrated Modular Analytics system - PAPP-A Test; 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 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 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, Dimension Vista 1000T Intelligent Lab System - Testosterone Assay; Siemens Healthcare GmbH, Dimension Vista 3000T Intelligent Lab System - Testosterone 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 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; Tecan Group Ltd, 17-OH-Progesterone Neonatal Screening Assay; Thermo Fisher Scientific Inc, Cascadion SM Clinical Analyzer - Total Testosterone Assay; University of Edinburgh, Biomarker Diagnostic Test - Ectopic Pregnancy; University of Otago, Biomarker-based Diagnostic Assay - Anti-Mullerian Hormone


Companies

AgPlus Diagnostics LTD

Albert Einstein College of Medicine

Aura Biotechnologies Pvt Ltd

Beckman Coulter Inc

Boditech Med Inc

China Medical Technologies Inc

DiaSorin SpA

Ellume

Fujirebio Diagnostics Inc

Genovum Sp. z o.o.

Hebrew University of Jerusalem

Immunodiagnostic Systems Holdings plc

King's College London

Labsystems Diagnostics Oy

Lucine Biotechnology, Inc.

Mindray Medical International Ltd

Northwestern University

Oasis Diagnostics Corp

Orangelife

Paramedical Srl

PerkinElmer Inc

Proteomika

QuickCheck Health Inc

Roche Diagnostics International Ltd

Shahid Beheshti University

Siemens Healthcare GmbH

SomaLogic Inc

Swan Diagnostics Ltd

Sysmex Corp

Tecan Group Ltd

Thermo Fisher Scientific Inc

University of Edinburgh

University of Otago

Reproductive Hormones and Proteins Tests-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Reproductive Hormones and Proteins Tests-Medical Devices Pipeline Assessment, 2018" provides an overview of Reproductive Hormones and Proteins 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 Reproductive Hormones and Proteins 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 Reproductive Hormones and Proteins 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 Reproductive Hormones and Proteins 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 Reproductive Hormones and Proteins 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 5

1.2 List of Figures 8

2 Introduction 9

2.1 Reproductive Hormones and Proteins Tests Overview 9

3 Products under Development 10

3.1 Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 10

3.2 Reproductive Hormones and Proteins Tests-Pipeline Products by Segment 11

3.3 Reproductive Hormones and Proteins Tests-Pipeline Products by Territory 12

3.4 Reproductive Hormones and Proteins Tests-Pipeline Products by Regulatory Path 13

3.5 Reproductive Hormones and Proteins Tests-Pipeline Products by Estimated Approval Date 14

4 Reproductive Hormones and Proteins Tests-Pipeline Products under Development by Companies 15

4.1 Reproductive Hormones and Proteins Tests Companies-Pipeline Products by Stage of Development 15

4.2 Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 17

5 Reproductive Hormones and Proteins Tests Companies and Product Overview 20

5.1 AgPlus Diagnostics LTD Company Overview 20

5.2 Albert Einstein College of Medicine Company Overview 21

5.3 Aura Biotechnologies Pvt Ltd Company Overview 22

5.4 Beckman Coulter Inc Company Overview 23

5.5 Boditech Med Inc Company Overview 27

5.6 China Medical Technologies Inc (Inactive) Company Overview 28

5.7 DiaSorin SpA Company Overview 29

5.8 Ellume Company Overview 31

5.9 Fujirebio Diagnostics Inc Company Overview 32

5.10 Genovum Sp. z o.o. Company Overview 37

5.11 Hebrew University of Jerusalem Company Overview 38

5.12 Immunodiagnostic Systems Holdings plc Company Overview 40

5.13 King's College London Company Overview 43

5.14 Labsystems Diagnostics Oy Company Overview 44

5.15 Lucine Biotechnology, Inc. Company Overview 45

5.16 Mindray Medical International Ltd Company Overview 46

5.17 Northwestern University Company Overview 47

5.18 Oasis Diagnostics Corp Company Overview 49

5.19 Orangelife Company Overview 50

5.20 Paramedical Srl Company Overview 51

5.21 PerkinElmer Inc Company Overview 53

5.22 Proteomika Company Overview 54

5.23 QuickCheck Health Inc Company Overview 55

5.24 Roche Diagnostics International Ltd Company Overview 56

5.25 Shahid Beheshti University Company Overview 59

5.26 Siemens Healthcare GmbH Company Overview 60

5.27 SomaLogic Inc Company Overview 71

5.28 Swan Diagnostics Ltd Company Overview 72

5.29 Sysmex Corp Company Overview 73

5.30 Tecan Group Ltd Company Overview 75

5.31 Thermo Fisher Scientific Inc Company Overview 76

5.32 University of Edinburgh Company Overview 77

5.33 University of Otago Company Overview 78

6 Reproductive Hormones and Proteins Tests- Recent Developments 79

6.1 Jun 21, 2018: Sera Prognostics Appoints Dr. Garrett K. Lam as Chief Medical Officer 79

6.2 Jun 20, 2018: Immunodiagnostic Systems: Final Results for year ended 31 March 2018 80

6.3 Jun 19, 2018: Sera Prognostics Collaborates with Christiana Care Health System to Launch New Preterm Birth Study with PreTRM Test 84

6.4 Jun 12, 2018: Change at the top of the Segment Advanced Therapies at Siemens Healthineers 85

6.5 Jun 07, 2018: Blood test may identify pregnant women at risk of premature birth 85

7 Appendix 171

7.1 Methodology 171

7.2 About GlobalData 174

7.3 Contact Us 174

7.4 Disclaimer 174


List Of Figure

1.2 List of Figures

Figure 1: Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 11

Figure 2: Reproductive Hormones and Proteins Tests-Pipeline Products by Segment 12

Figure 3: Reproductive Hormones and Proteins Tests-Pipeline Products by Territory 13

Figure 4: Reproductive Hormones and Proteins Tests-Pipeline Products by Regulatory Path 14

Figure 5: Reproductive Hormones and Proteins Tests-Pipeline Products by Estimated Approval Date 15


List Of Table

1.1 List of Tables

Table 1: Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 11

Table 2: Reproductive Hormones and Proteins Tests-Pipeline Products by Segment 12

Table 3: Reproductive Hormones and Proteins Tests-Pipeline Products by Territory 13

Table 4: Reproductive Hormones and Proteins Tests-Pipeline Products by Regulatory Path 14

Table 5: Reproductive Hormones and Proteins Tests-Pipeline Products by Estimated Approval Date 15

Table 6: Reproductive Hormones and Proteins Tests Companies-Pipeline Products by Stage of Development 16

Table 7: Reproductive Hormones and Proteins Tests-Pipeline Products by Stage of Development 18

Table 8: AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 21

Table 9: AgPlus Diagnostic System-Testosterone Assay-Product Status 21

Table 10: AgPlus Diagnostic System-Testosterone Assay-Product Description 21

Table 11: Albert Einstein College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 22

Table 12: Estradiol Assay-Product Status 22

Table 13: Estradiol Assay-Product Description 22

Table 14: Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Table 15: AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit-Product Status 23

Table 16: AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit-Product Description 23

Table 17: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Table 18: Access 2 Immunoassay System-Sensitive Estradiol-Product Status 24

Table 19: Access 2 Immunoassay System-Sensitive Estradiol-Product Description 24

Table 20: UniCel DxC 660i Synchron Access Clinical System-AMH Assay-Product Status 25

Table 21: UniCel DxC 660i Synchron Access Clinical System-AMH Assay-Product Description 25

Table 22: UniCel DxI 600 Access Immunoassay System-AMH Assay-Product Status 25

Table 23: UniCel DxI 600 Access Immunoassay System-AMH Assay-Product Description 25

Table 24: UniCel DxI 600 Access Immunoassay System-Sensitive Estradiol Assay-Product Status 26

Table 25: UniCel DxI 600 Access Immunoassay System-Sensitive Estradiol Assay-Product Description 26

Table 26: UniCel DxI 800 Access Immunoassay System-AMH Assay-Product Status 26

Table 27: UniCel DxI 800 Access Immunoassay System-AMH Assay-Product Description 26

Table 28: UniCel DxI 800 Access Immunoassay System-Sensitive Estradiol Assay-Product Status 27

Table 29: UniCel DxI 800 Access Immunoassay System-Sensitive Estradiol Assay-Product Description 27

Table 30: Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Table 31: AFIAS-6 Progesterone Assay-Product Status 28

Table 32: AFIAS-6 Progesterone Assay-Product Description 28

Table 33: China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 29

Table 34: Infertility Reagent Test kit-ECLIA Analyzer-Product Status 29

Table 35: Infertility Reagent Test kit-ECLIA Analyzer-Product Description 29

Table 36: DiaSorin SpA Pipeline Products & Ongoing Clinical Trials Overview 30

Table 37: Estradiol II Assay-Product Status 30

Table 38: Estradiol II Assay-Product Description 30

Table 39: Progesterone II Assay-Product Status 31

Table 40: Progesterone II Assay-Product Description 31

Table 41: Ellume Pipeline Products & Ongoing Clinical Trials Overview 32

Table 42: ESP-Based Diagnostic Test-Pregnancy-Product Status 32

Table 43: ESP-Based Diagnostic Test-Pregnancy-Product Description 32

Table 44: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Table 45: Lumipulse G-AFP Assay-Product Status 33

Table 46: Lumipulse G-AFP Assay-Product Description 33

Table 47: Lumipulse G1200-AMH-Product Status 34

Table 48: Lumipulse G1200-AMH-Product Description 34

Table 49: Lumipulse G1200-Estradiol Assay-Product Status 34

Table 50: Lumipulse G1200-Estradiol Assay-Product Description 35

Table 51: Lumipulse G1200-FSH Test-Product Status 35

Table 52: Lumipulse G1200-FSH Test-Product Description 35

Table 53: Lumipulse G1200-Progestrone Test-Product Status 36

Table 54: Lumipulse G1200-Progestrone Test-Product Description 36

Table 55: Lumipulse G1200-Testosterone Assay-Product Status 36

Table 56: Lumipulse G1200-Testosterone Assay-Product Description 36

Table 57: Lumipulse G1200-Total -HCG Assay-Product Status 37

Table 58: Lumipulse G1200-Total -HCG Assay-Product Description 37

Table 59: Genovum Sp. z o.o. Pipeline Products & Ongoing Clinical Trials Overview 38

Table 60: Diagnostic Test-Polycystic Ovarian Syndrome-Product Status 38

Table 61: Diagnostic Test-Polycystic Ovarian Syndrome-Product Description 38

Table 62: Hebrew University of Jerusalem Pipeline Products & Ongoing Clinical Trials Overview 39

Table 63: Diagnostic Assay-Ovulation-Product Status 39

Table 64: Diagnostic Assay-Ovulation-Product Description 39

Table 65: Diagnostic Assay-Pregnancy-Product Status 40

Table 66: Diagnostic Assay-Pregnancy-Product Description 40

Table 67: Immunodiagnostic Systems Holdings plc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 68: IDS-iSYS-17-beta Estradiol Assay-Product Status 41

Table 69: IDS-iSYS-17-beta Estradiol Assay-Product Description 41

Table 70: IDS-iSYS-Total Testosterone Assay-Product Status 42

Table 71: IDS-iSYS-Total Testosterone Assay-Product Description 42

Table 72: IDS-iSYS Free Testosterone Assay-Product Status 42

Table 73: IDS-iSYS Free Testosterone Assay-Product Description 43

Table 74: King's College London Pipeline Products & Ongoing Clinical Trials Overview 44

Table 75: Elafin Test-Preterm Birth-Product Status 44

Table 76: Elafin Test-Preterm Birth-Product Description 44

Table 77: Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 45

Table 78: Fluoro Enzymatic Immuno Assay-Neonatal 17-OH-Progesterone FEIA-Product Status 45

Table 79: Fluoro Enzymatic Immuno Assay-Neonatal 17-OH-Progesterone FEIA-Product Description 45

Table 80: Lucine Biotechnology, Inc. Pipeline Products & Ongoing Clinical Trials Overview 46

Table 81: Salivary Diagnostic Test-PCOS-Product Status 46

Table 82: Salivary Diagnostic Test-PCOS-Product Description 46

Table 83: Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

Table 84: CL-2000i-DHEA-S Test-Product Status 47

Table 85: CL-2000i-DHEA-S Test-Product Description 47

Table 86: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 48

Table 87: At Home Menopause Test-Product Status 48

Table 88: At Home Menopause Test-Product Description 48

Table 89: Female Fertility Test-Product Status 49

Table 90: Female Fertility Test-Product Description 49

Table 91: Oasis Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 50

Table 92: VerOFy Salivary Based Test-Estradiol-Product Status 50

Table 93: VerOFy Salivary Based Test-Estradiol-Product Description 50

Table 94: Orangelife Pipeline Products & Ongoing Clinical Trials Overview 51

Table 95: Pregnancy Kit-Product Status 51

Table 96: Pregnancy Kit-Product Description 51

Table 97: Paramedical Srl Pipeline Products & Ongoing Clinical Trials Overview 52

Table 98: PKL PPC 960-AMH-Product Status 52

Table 99: PKL PPC 960-AMH-Product Description 52

Table 100: PKL PPC 960-Inhibin A-Product Status 53

Table 101: PKL PPC 960-Inhibin A-Product Description 53

Table 102: PerkinElmer Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Table 103: Diagnostic Test-Preterm Birth-Product Status 54

Table 104: Diagnostic Test-Preterm Birth-Product Description 54

Table 105: Proteomika Pipeline Products & Ongoing Clinical Trials Overview 55

Table 106: Proimplant-Product Status 55

Table 107: Proimplant-Product Description 55

Table 108: QuickCheck Health Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 109: Diagnostic Test-Pregnancy-Product Status 56

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Products

AgPlus Diagnostics LTD, AgPlus Diagnostic System - Testosterone Assay; Albert Einstein College of Medicine, Estradiol Assay; Aura Biotechnologies Pvt Ltd, AURA Quant Anti-Mullerian hormone (AMH) ELISA Kit; 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 800 Access Immunoassay System - AMH Assay; Beckman Coulter Inc, UniCel DxI 800 Access Immunoassay System - Sensitive Estradiol Assay; Boditech Med Inc, AFIAS-6 Progesterone Assay; China Medical Technologies Inc (Inactive), Infertility Reagent Test kit - ECLIA Analyzer; DiaSorin SpA, Estradiol II Assay; DiaSorin SpA, Progesterone II Assay; Ellume, ESP-Based Diagnostic Test - Pregnancy; Fujirebio Diagnostics Inc, Lumipulse G - AFP 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; 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 Free Testosterone Assay; King's College London, Elafin Test - Preterm Birth; Labsystems Diagnostics Oy, Fluoro Enzymatic Immuno Assay - Neonatal 17-OH-Progesterone FEIA; Lucine Biotechnology, Inc., Salivary Diagnostic Test - PCOS; Mindray Medical International Ltd, CL-2000i - DHEA-S Test; Northwestern University, At Home Menopause Test; Northwestern University, Female Fertility Test; Oasis Diagnostics Corp, VerOFy Salivary Based Test - Estradiol; Orangelife, Pregnancy Kit; Paramedical Srl, PKL PPC 960 - AMH; Paramedical Srl, PKL PPC 960 - Inhibin A; PerkinElmer Inc, Diagnostic Test - Preterm Birth; Proteomika, Proimplant; QuickCheck Health Inc, Diagnostic Test - Pregnancy; 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, Diagnostic Assay - AMH; Roche Diagnostics International Ltd, Integrated Modular Analytics system - PAPP-A Test; 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 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 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, Dimension Vista 1000T Intelligent Lab System - Testosterone Assay; Siemens Healthcare GmbH, Dimension Vista 3000T Intelligent Lab System - Testosterone 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 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; Tecan Group Ltd, 17-OH-Progesterone Neonatal Screening Assay; Thermo Fisher Scientific Inc, Cascadion SM Clinical Analyzer - Total Testosterone Assay; University of Edinburgh, Biomarker Diagnostic Test - Ectopic Pregnancy; University of Otago, Biomarker-based Diagnostic Assay - Anti-Mullerian Hormone


Companies

AgPlus Diagnostics LTD

Albert Einstein College of Medicine

Aura Biotechnologies Pvt Ltd

Beckman Coulter Inc

Boditech Med Inc

China Medical Technologies Inc

DiaSorin SpA

Ellume

Fujirebio Diagnostics Inc

Genovum Sp. z o.o.

Hebrew University of Jerusalem

Immunodiagnostic Systems Holdings plc

King's College London

Labsystems Diagnostics Oy

Lucine Biotechnology, Inc.

Mindray Medical International Ltd

Northwestern University

Oasis Diagnostics Corp

Orangelife

Paramedical Srl

PerkinElmer Inc

Proteomika

QuickCheck Health Inc

Roche Diagnostics International Ltd

Shahid Beheshti University

Siemens Healthcare GmbH

SomaLogic Inc

Swan Diagnostics Ltd

Sysmex Corp

Tecan Group Ltd

Thermo Fisher Scientific Inc

University of Edinburgh

University of Otago