Hematology Rapid Tests & Point of Care (POC) - Medical Devices Pipeline Assessment, 2018

Hematology Rapid Tests & Point of Care (POC) - Medical Devices Pipeline Assessment, 2018


  • Products Id :- GDME0647EPD
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Executive Summary

Hematology Rapid Tests & Point of Care (POC)-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Hematology Rapid Tests & Point of Care (POC)-Medical Devices Pipeline Assessment, 2018" provides an overview of Hematology Rapid Tests & Point of Care (POC) 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 Hematology Rapid Tests & Point of Care (POC) 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 Hematology Rapid Tests & Point of Care (POC) 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 Hematology Rapid Tests & Point of Care (POC) 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 Hematology Rapid Tests & Point of Care (POC) under development

- Develop market-entry and market expansion strategies

- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

- In-depth analysis of the product's current stage of development, territory and estimated launch date.



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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 3

1.2 List of Figures 5

2 Introduction 6

2.1 Hematology Rapid Tests & Point of Care (POC) Overview 6

3 Products under Development 7

3.1 Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 7

3.2 Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Segment 8

3.3 Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Territory 9

3.4 Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Regulatory Path 10

3.5 Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Estimated Approval Date 11

4 Hematology Rapid Tests & Point of Care (POC)-Pipeline Products under Development by Companies 12

4.1 Hematology Rapid Tests & POC Companies-Pipeline Products by Stage of Development 12

4.2 Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 13

5 Hematology Rapid Tests & Point of Care (POC) Companies and Product Overview 14

5.1 Beckman Coulter Inc Company Overview 14

5.2 BioMedomics Inc Company Overview 15

5.3 Biosurfit, SA Company Overview 17

5.4 Correlia Biosystems, Inc. Company Overview 19

5.5 DxDiscovery, Inc. Company Overview 20

5.6 Dynasil Corporation of America Company Overview 21

5.7 ET Healthcare, Inc. Company Overview 22

5.8 genedrive plc Company Overview 23

5.9 KeenCAT Technologies Company Overview 24

5.10 Ohio State University Company Overview 25

5.11 PortaScience Inc Company Overview 26

5.12 Siemens Healthcare GmbH Company Overview 27

5.13 T2 Biosystems Inc Company Overview 32

5.14 University of Glasgow Company Overview 34

5.15 University of Melbourne Company Overview 35

6 Hematology Rapid Tests & Point of Care (POC)-Recent Developments 36

6.1 Jun 25, 2018: Beckman Coulter Files a 510(k) Submission with the FDA for Its Early Sepsis Indicator 36

6.2 Jun 14, 2018: Consort Medical delivered another year of good growth in revenue and profit 36

6.3 Jun 12, 2018: Change at the top of the Segment Advanced Therapies at Siemens Healthineers 39

6.4 May 29, 2018: Akers Biosciences Announces Board Change 40

6.5 May 25, 2018: Akers Biosciences Receives Notice of Delinquent Form 10-Q Filing from Nasdaq 40

6.6 May 08, 2018: Quidel Announces First Quarter 2018 Financial Results 41

6.7 May 08, 2018: Bio-Rad Announces First Quarter 2018 Financial Results 42

6.8 May 03, 2018: Beckman Coulter Achieves CE Mark for Its Early Sepsis Indicator 43

6.9 May 03, 2018: Siemens Healthineers fully on track to meet the targets 43

6.10 Apr 27, 2018: Universal Biosensors releases Q1 FY2018 results-investing in new product development while building cash position 44

6.11 Apr 26, 2018: Akers Biosciences: Directorate Change 45

6.12 Apr 26, 2018: Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2018 and Declares a 13% Increase in Quarterly Cash Dividend 45

6.13 Apr 26, 2018: Consort Medical: Director Declaration 47

6.14 Apr 16, 2018: A high-sensitive blood test when it is safe to return to play after a sports-related concussion 48

6.15 Apr 12, 2018: Akers Biosciences Expands Outsourced US Distribution Capabilities for Heparin PF4 Rapid Test 49

6.16 Apr 03, 2018: Akers Biosciences Reports Earnings for Fiscal Year 2017 49

6.17 Mar 14, 2018: EKF Diagnostics Holdings: 2017 Final results 54

6.18 Feb 28, 2018: Biohit Group Financial Statement Release 2017 59

6.19 Feb 27, 2018: Bio-Rad Reports Fourth-Quarter and Full-Year 2017 Financial Results 66

6.20 Feb 21, 2018: Quidel Reports Fourth Quarter and Full Year 2017 Financial Results 67

6.21 Feb 20, 2018: Changes to Biohit Oyj's Management Team 70

6.22 Feb 19, 2018: Quidel to establish new Business Service Centre in Galway city 70

6.23 Jan 30, 2018: Siemens Healthineers Names Deepak Nath Head of Laboratory Diagnostics 71

6.24 Jan 22, 2018: Bio-Rad Gains Additional U.S. FDA Clearances for Blood Typing Products, Expanding its Offering for the Blood Testing Market 71

6.25 Jan 09, 2018: Abaxis Reports Preliminary Financial Performance for the Third Quarter of Fiscal 2018 72

6.26 Dec 07, 2017: NanoString Technologies Highlights Advances in Precision Oncology at the 59th Annual Meeting of the American Society of Hematology 72

6.27 Dec 05, 2017: Consort Medical: Interim results 73

6.28 Nov 29, 2017: Siemens plans to list Siemens Healthineers on Frankfurt Stock Exchange 74

6.29 Nov 15, 2017: Akers Biosciences Announces Q3 2017 Earnings 74

6.30 Nov 02, 2017: Bio-Rad Reports Third-Quarter 2017 Financial Results 85

6.31 Nov 01, 2017: Quidel Reports Third Quarter 2017 Financial Results 86

6.32 Oct 24, 2017: Abaxis Reports Financial Performance for the Second Quarter of Fiscal 2018 and Declares Quarterly Cash Dividend 88

6.33 Oct 24, 2017: Universal Biosensors releases Q3 2017 results-continued revenue growth strengthens net cash position 90

6.34 Oct 23, 2017: Meridian Bioscience Comments on FDA Press Statement Regarding Its Warning Letter Issued to Magellan Diagnostics 91

6.35 Sep 11, 2017: EKF Diagnostics Holdings: Half Yearly Report 91

6.36 Sep 07, 2017: Akers Biosciences Hires Medical Device Specialist to Lead US Sales and Distribution 91

6.37 Aug 17, 2017: Biohit Group Half Year Financial Report 2017 92

6.38 Aug 15, 2017: Akers Biosciences: Financial Results for the Six Months Ended June 30, 2017 96

6.39 Aug 15, 2017: Akers Biosciences Announces Q2 2017 Earnings 98

6.40 Aug 08, 2017: Akers Biosciences Announces Board Changes 103

6.41 Aug 07, 2017: Rick Legleiter Appointed Chief Executive Officer, Chairman Succession and Board Renewal Process 105

6.42 Aug 03, 2017: Bio-Rad Reports Second-Quarter 2017 Financial Results 106

6.43 Aug 03, 2017: Akers Biosciences Announces Second Quarter Trading Update 107

6.44 Jul 31, 2017: Sysmex America Completes Expansion of Reagents Manufacturing Facility, Opens Doors to Latin American Sales Office in Doral, Florida 107

6.45 Jul 27, 2017: Abaxis Reports Financial Performance for the First Quarter of Fiscal 2018 and Declares Quarterly Cash Dividend 107

6.46 Jul 26, 2017: Quidel Reports Second Quarter 2017 Financial Results 109

7 Appendix 111

7.1 Methodology 111

7.2 About GlobalData 114

7.3 Contact Us 114

7.4 Disclaimer 114

1.2 List of Figures

Figure 1: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 7

Figure 2: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Segment 8

Figure 3: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Territory 9

Figure 4: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Regulatory Path 10

Figure 5: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Estimated Approval Date 11

1.1 List of Tables

Table 1: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 7

Table 2: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Segment 8

Table 3: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Territory 9

Table 4: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Regulatory Path 10

Table 5: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Estimated Approval Date 11

Table 6: Hematology Rapid Tests & POC Companies-Pipeline Products by Stage of Development 12

Table 7: Hematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 13

Table 8: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 14

Table 9: DxH 900-Early Sepsis Indicator-Product Status 14

Table 10: DxH 900-Early Sepsis Indicator-Product Description 14

Table 11: BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 15

Table 12: Rapid Quantitative Heparin-Induced Thrombocytopenia (H.I.T.) Test-Product Status 15

Table 13: Rapid Quantitative Heparin-Induced Thrombocytopenia (H.I.T.) Test-Product Description 15

Table 14: Sickle SCAN-Product Status 16

Table 15: Sickle SCAN-Product Description 16

Table 16: Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 17

Table 17: Spinit Device-Blood Quantitation Anemia Assay-Product Status 17

Table 18: Spinit Device-Blood Quantitation Anemia Assay-Product Description 17

Table 19: Spinit Device-Thrombocytopenia Assay-Product Status 18

Table 20: Spinit Device-Thrombocytopenia Assay-Product Description 18

Table 21: Correlia Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19

Table 22: Electrokinetic Lateral Flow Test-Product Status 19

Table 23: Electrokinetic Lateral Flow Test-Product Description 19

Table 24: DxDiscovery, Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

Table 25: Diagnostic Assay-Sickle Cell Disease-Product Status 20

Table 26: Diagnostic Assay-Sickle Cell Disease-Product Description 20

Table 27: Dynasil Corporation of America Pipeline Products & Ongoing Clinical Trials Overview 21

Table 28: Diagnostic Test-Hemophilia-Product Status 21

Table 29: Diagnostic Test-Hemophilia-Product Description 21

Table 30: ET Healthcare, Inc. Pipeline Products & Ongoing Clinical Trials Overview 22

Table 31: Pylon Assay-D-Dimer-Product Status 22

Table 32: Pylon Assay-D-Dimer-Product Description 22

Table 33: genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 23

Table 34: Genedrive-Factor V Leiden-Product Status 23

Table 35: Genedrive-Factor V Leiden-Product Description 23

Table 36: KeenCAT Technologies Pipeline Products & Ongoing Clinical Trials Overview 24

Table 37: HematoCAT-Product Status 24

Table 38: HematoCAT-Product Description 24

Table 39: Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 25

Table 40: Diagnostic Assay-Thrombotic Thrombocytopenic Purpura-Product Status 25

Table 41: Diagnostic Assay-Thrombotic Thrombocytopenic Purpura-Product Description 25

Table 42: PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Table 43: PortaWBC-Product Status 26

Table 44: PortaWBC-Product Description 26

Table 45: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 27

Table 46: Advia 120 Hematology System-IRF Test-Product Status 27

Table 47: Advia 120 Hematology System-IRF Test-Product Description 27

Table 48: ADVIA 120 Hematology System-MPC Test-Product Status 28

Table 49: ADVIA 120 Hematology System-MPC Test-Product Description 28

Table 50: Advia 120 Hematology System-MPM Test-Product Status 28

Table 51: Advia 120 Hematology System-MPM Test-Product Description 29

Table 52: ADVIA 2120 Hematology System-MPC Test-Product Status 29

Table 53: ADVIA 2120 Hematology System-MPC Test-Product Description 29

Table 54: Advia 2120 Hematology System-MPM Test-Product Status 30

Table 55: Advia 2120 Hematology System-MPM Test-Product Description 30

Table 56: ADVIA 2120i Hematology System-MPC Test-Product Status 30

Table 57: ADVIA 2120i Hematology System-MPC Test-Product Description 31

Table 58: ADVIA 2120i Hematology System-MPM Test-Product Status 31

Table 59: ADVIA 2120i Hematology System-MPM Test-Product Description 31

Table 60: T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 61: T2HemoStat-Product Status 32

Table 62: T2HemoStat-Product Description 32

Table 63: T2MR Assay-Platelet Function Testing-Product Status 33

Table 64: T2MR Assay-Platelet Function Testing-Product Description 33

Table 65: University of Glasgow Pipeline Products & Ongoing Clinical Trials Overview 34

Table 66: Immunoassay-Haemoglobin-Product Status 34

Table 67: Immunoassay-Haemoglobin-Product Description 34

Table 68: University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 35

Table 69: Thrombin Generation Assay-Product Status 35

Table 70: Thrombin Generation Assay-Product Description 35

Table 71: Glossary 113

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Beckman Coulter Inc

BioMedomics Inc

Biosurfit, SA

Correlia Biosystems, Inc.

DxDiscovery, Inc.

Dynasil Corporation of America

ET Healthcare, Inc.

genedrive plc

KeenCAT Technologies

Ohio State University

PortaScience Inc

Siemens Healthcare GmbH

T2 Biosystems Inc

University of Glasgow

University of Melbourne

Beckman Coulter Inc, DxH 900 - Early Sepsis Indicator; BioMedomics Inc, Rapid Quantitative Heparin-Induced Thrombocytopenia (H.I.T.) Test; BioMedomics Inc, Sickle SCAN; Biosurfit, SA, Spinit Device - Blood Quantitation Anemia Assay; Biosurfit, SA, Spinit Device - Thrombocytopenia Assay; Correlia Biosystems, Inc., Electrokinetic Lateral Flow Test; DxDiscovery, Inc., Diagnostic Assay - Sickle Cell Disease; Dynasil Corporation of America, Diagnostic Test - Hemophilia; ET Healthcare, Inc., Pylon Assay - D-Dimer; genedrive plc, Genedrive - Factor V Leiden; KeenCAT Technologies, HematoCAT; Ohio State University, Diagnostic Assay - Thrombotic Thrombocytopenic Purpura; PortaScience Inc, PortaWBC; Siemens Healthcare GmbH, Advia 120 Hematology System - IRF Test; Siemens Healthcare GmbH, ADVIA 120 Hematology System - MPC Test; Siemens Healthcare GmbH, Advia 120 Hematology System - MPM Test; Siemens Healthcare GmbH, ADVIA 2120 Hematology System - MPC Test; Siemens Healthcare GmbH, Advia 2120 Hematology System - MPM Test; Siemens Healthcare GmbH, ADVIA 2120i Hematology System - MPC Test; Siemens Healthcare GmbH, ADVIA 2120i Hematology System - MPM Test; T2 Biosystems Inc, T2HemoStat; T2 Biosystems Inc, T2MR Assay - Platelet Function Testing; University of Glasgow, Immunoassay - Haemoglobin; University of Melbourne, Thrombin Generation Assay

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