Haematology Rapid Tests & Point of Care (POC)-Medical Devices Pipeline Assessment, 2017

Haematology Rapid Tests & Point of Care (POC)-Medical Devices Pipeline Assessment, 2017


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Executive Summary

Haematology Rapid Tests & Point of Care (POC)-Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, "Haematology Rapid Tests & Point of Care (POC)-Medical Devices Pipeline Assessment, 2017" provides an overview of Haematology 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 Haematology 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 Haematology 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 Haematology 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 Haematology 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 5

1.2 List of Figures 6

2 Introduction 7

2.1 Haematology Rapid Tests & Point of Care (POC) Overview 7

3 Products under Development 8

3.1 Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 8

3.2 Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Segment 9

3.3 Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Territory 10

3.4 Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Regulatory Path 11

3.5 Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Estimated Approval Date 12

4 Haematology Rapid Tests & Point of Care (POC)-Pipeline Products under Development by Companies 13

4.1 Haematology Rapid Tests & Point of Care (POC) Companies-Pipeline Products by Stage of Development 13

4.2 Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 14

5 Haematology Rapid Tests & Point of Care (POC) Companies and Product Overview 16

5.1 Atomo Diagnostics Pty Limited Company Overview 16

5.1.1 Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 16

5.2 BioMedomics Inc Company Overview 17

5.2.1 BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 17

5.3 Biosurfit, SA Company Overview 18

5.3.1 Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 18

5.4 Carclo Diagnostic Solutions Ltd Company Overview 20

5.4.1 Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 20

5.5 Cascade Metrix, Inc. Company Overview 21

5.5.1 Cascade Metrix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21

5.6 Correlia Biosystems, Inc. Company Overview 22

5.6.1 Correlia Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 22

5.7 EKF Diagnostics Holdings Plc Company Overview 23

5.7.1 EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 23

5.8 Emosis SAS Company Overview 24

5.8.1 Emosis SAS Pipeline Products & Ongoing Clinical Trials Overview 24

5.9 ET Healthcare, Inc. Company Overview 25

5.9.1 ET Healthcare, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25

5.10 genedrive plc Company Overview 26

5.10.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 26

5.11 Helena Laboratories Corp. Company Overview 27

5.11.1 Helena Laboratories Corp. Pipeline Products & Ongoing Clinical Trials Overview 27

5.12 KeenCAT Technologies Company Overview 34

5.12.1 KeenCAT Technologies Pipeline Products & Ongoing Clinical Trials Overview 34

5.13 Ohio State University Company Overview 35

5.13.1 Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 35

5.14 PortaScience Inc Company Overview 36

5.14.1 PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.15 Sanguina LLC Company Overview 37

5.15.1 Sanguina LLC Pipeline Products & Ongoing Clinical Trials Overview 37

5.16 Siemens Healthcare GmbH Company Overview 38

5.16.1 Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 38

5.17 T2 Biosystems Inc Company Overview 44

5.17.1 T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.18 The University of Melbourne Company Overview 46

5.18.1 The University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 46

5.19 Universal Biosensors Inc Company Overview 47

5.19.1 Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 47

6 Haematology Rapid Tests & Point of Care (POC)- Recent Developments 48

6.1 Jun 15, 2017: Consort Medical: Full year results 48

6.2 Jun 14, 2017: Alere Reports First Quarter 2017 Financial Results 48

6.3 Jun 05, 2017: Alere Files Form 10-K, Reports Fourth Quarter and Full Year 2016 Financial Results 49

6.4 May 22, 2017: Alere Provides Preliminary Unaudited Financial Results 50

6.5 May 19, 2017: Henry Ford Health System to Present Webinar on T2MR 50

6.6 May 17, 2017: FDA warns Americans about risk of inaccurate results from certain lead tests 51

6.7 May 16, 2017: Akers Biosciences Announces Q1 2017 Earnings 52

6.8 May 04, 2017: Lea Paloheimo appointed Biohit Oyj's R&D and production director 53

6.9 May 04, 2017: Bio-Rad Reports First-Quarter 2017 Financial Results 54

6.10 Apr 27, 2017: Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2017 and Declares Quarterly Cash Dividend 55

6.11 Apr 24, 2017: Quidel Reports First Quarter 2017 Financial Results 56

6.12 Apr 11, 2017: Akers Bioscience: Financial Results for the Year Ended December 31, 2016 57

6.13 Apr 11, 2017: Akers Biosciences Reports Earnings for Fiscal Year 2016 58

6.14 Apr 10, 2017: Akers Biosciences to Commercialize Heparin PF4 Rapid Test in Puerto Rico 62

6.15 Mar 30, 2017: Akers Biosciences Reports Preliminary Unaudited Earnings Highlights for Fiscal Year 2016 63

6.16 Mar 29, 2017: Sysmex America Announces Leadership Promotions 64

6.17 Mar 28, 2017: EMOSIS Announces the Opening of a Subsidiary in Israel 65

6.18 Mar 27, 2017: EMOSIS announces the appointment of Nicolas Rufin as Head of marketing and sales 65

6.19 Mar 26, 2017: Emosis Announces The Appointment Of Aurore Andre As Emosis CEO 66

6.20 Mar 20, 2017: EKF Diagnostics Holdings: Final results 66

6.21 Mar 13, 2017: Bio-Rad Intends to Propose Three New Independent Directors 67

6.22 Mar 13, 2017: Bio-Rad Initiates Long Term Financial Guidance; Commits to Defining Long Term Capital Allocation Targets and Hosting an Annual Investor Day 68

6.23 Mar 09, 2017: Alere Provides Update on Arriva Medical 69

6.24 Feb 23, 2017: VBio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 69

6.25 Feb 23, 2017: Bio-Rad Reports Fourth-Quarter and Full-Year 2016 Financial Results 71

6.26 Feb 20, 2017: Biohit Group Financial Statement Release 2016 73

6.27 Feb 20, 2017: Sysmex America to Distribute Erythrocyte Sedimentation Rate Products from Alifax 78

6.28 Feb 08, 2017: Quidel Reports Fourth Quarter and Full Year 2016 Financial Results 78

6.29 Feb 01, 2017: Akers Biosciences Announces Trading Update For The Twelve Months Ended December 31, 2016 80

6.30 Jan 26, 2017: Abaxis Reports Financial Performance for the Third Quarter of Fiscal 2017, Declares Quarterly Cash Dividend 81

6.31 Jan 23, 2017: Quidel Announces Modification of Revenue Reporting Categories 82

6.32 Jan 10, 2017: Abaxis Reports Preliminary Financial Performance For The Third Quarter Of Fiscal 2017 83

6.33 Jan 06, 2017: Quidel Announces Preliminary Revenue for Fourth Quarter 2016 83

6.34 Jan 04, 2017: Alere Laboratory Receives ABFT Accreditation 84

6.35 Jan 04, 2017: Alere Provides Update on Arriva Medical 84

6.36 Dec 28, 2016: Alere Provides Update on Arriva Medical 85

6.37 Dec 19, 2016: Akers Biosciences Announces 3-year Agreement with Greater New York Hospital Association for PIFA Heparin/Platelet Factor-4 Rapid Assay 85

6.38 Dec 19, 2016: Akers Biosciences Announces 3-year Agreement with Greater New York Hospital Association for PIFA PLUSS PF4 Rapid Assay 86

6.39 Dec 14, 2016: Beckman Coulter appoints IT Product Manager for Northern Europe 87

6.40 Dec 14, 2016: Siemens Healthineers to significantly expand its Walpole, Mass. Laboratory Diagnostic manufacturing facility 88

6.41 Dec 14, 2016: Consort Medical: Directorate Change 88

6.42 Dec 08, 2016: Khang & Khang Announces Securities Class Action Lawsuit against Alere and Reminds Investors with Losses to Contact the Firm 89

6.43 Dec 07, 2016: Abbott Seeks To Terminate Alere Acquisition 89

6.44 Dec 06, 2016: Consort Medical Reports Interim Results Results For The Six Months Ended 31 October 2016 89

6.45 Nov 25, 2016: Consort Medical: CFO Appointment 92

6.46 Nov 14, 2016: Akers Biosciences Announces Q3 Earnings 92

6.47 Nov 04, 2016: Alere Reports Third Quarter 2016 Financial Results 94

6.48 Nov 01, 2016: Bio-Rad Reports Third-Quarter Currency-Neutral Revenue Growth of 9.1 Percent 94

6.49 Oct 26, 2016: Quidel Reports Third Quarter 2016 Financial Results 95

6.50 Oct 25, 2016: Abaxis Reports Financial Performance For The Second Quarter Of Fiscal 2017 97

6.51 Oct 24, 2016: Study links small RNA molecule to pregnancy complication 98

6.52 Sep 12, 2016: EKF Diagnostics Holdings: Half-year Report 100

6.53 Sep 06, 2016: Alere Reports Second Quarter 2016 Financial Results 103

6.54 Sep 01, 2016: Blood test for new breast cancer subtype delays its progression 103

6.55 Aug 26, 2016: Ilari Patrakka appointed Biohit Oyj's Sales and Marketing Director 104

6.56 Aug 25, 2016: Alere Recalls INRatio and INRatio2 PT/INR Monitoring System Due to Incorrect Test Results 104

6.57 Aug 18, 2016: Frank Witney Joins RareCyte Board of Directors 106

6.58 Aug 18, 2016: Biohit Group Half Year Financial report 2016 106

6.59 Aug 17, 2016: Alere Reports First Quarter 2016 Financial Results 122

6.60 Aug 17, 2016: Consort Medical Announces Directorate Change 123

6.61 Aug 11, 2016: Akers Biosciences Announces H1 and Q2 2016 Earnings 123

6.62 Aug 08, 2016: Alere Files Form 10-K, Reports Fourth Quarter and Full Year 2015 Financial Results 125

6.63 Aug 03, 2016: Bio-Rad Reports Second-Quarter 2016 Financial Results 127

7 Appendix 128

7.1 Methodology 128

7.2 About GlobalData 131

7.3 Contact Us 131

7.4 Disclaimer 131

1.2 List of Figures

Figure 1: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 8

Figure 2: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Segment 9

Figure 3: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Territory 10

Figure 4: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Regulatory Path 11

Figure 5: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Estimated Approval Date 12

1.1 List of Tables

Table 1: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 8

Table 2: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Segment 9

Table 3: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Territory 10

Table 4: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Regulatory Path 11

Table 5: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Estimated Approval Date 12

Table 6: Haematology Rapid Tests & Point of Care (POC) Companies-Pipeline Products by Stage of Development 13

Table 7: Haematology Rapid Tests & Point of Care (POC)-Pipeline Products by Stage of Development 14

Table 8: Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 16

Table 9: AtomoRapid-Coagulation Monitoring-Product Status 16

Table 10: AtomoRapid-Coagulation Monitoring-Product Description 16

Table 11: BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 17

Table 12: Sickle SCAN-Product Status 17

Table 13: Sickle SCAN-Product Description 17

Table 14: Biosurfit, SA Pipeline Products & Ongoing Clinical Trials Overview 18

Table 15: Spinit Device-Blood Quantitation Anemia Assay-Product Status 18

Table 16: Spinit Device-Blood Quantitation Anemia Assay-Product Description 18

Table 17: Spinit Device-Thrombocytopenia Assay-Product Status 19

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

Table 19: Carclo Diagnostic Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 20

Table 20: Micropoc-CAT-Haemostasis Assay-Product Status 20

Table 21: Micropoc-CAT-Haemostasis Assay-Product Description 20

Table 22: Cascade Metrix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21

Table 23: Multiple Blood Analytes Test-Product Status 21

Table 24: Multiple Blood Analytes Test-Product Description 21

Table 25: Correlia Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 22

Table 26: Electrokinetic Lateral Flow Test-Product Status 22

Table 27: Electrokinetic Lateral Flow Test-Product Description 22

Table 28: EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 23

Table 29: Point-Of-Care Test-Coagulation-Product Status 23

Table 30: Point-Of-Care Test-Coagulation-Product Description 23

Table 31: Emosis SAS Pipeline Products & Ongoing Clinical Trials Overview 24

Table 32: Diagnostic Test Kit-Heparin-Induced Thrombocytopenia-Product Status 24

Table 33: Diagnostic Test Kit-Heparin-Induced Thrombocytopenia-Product Description 24

Table 34: ET Healthcare, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25

Table 35: Pylon Assay-D-Dimer-Product Status 25

Table 36: Pylon Assay-D-Dimer-Product Description 25

Table 37: genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 26

Table 38: Genedrive-Factor V Leiden-Product Status 26

Table 39: Genedrive-Factor V Leiden-Product Description 26

Table 40: Helena Laboratories Corp. Pipeline Products & Ongoing Clinical Trials Overview 27

Table 41: Cascade Abrazo-APTT-Product Status 27

Table 42: Cascade Abrazo-APTT-Product Description 28

Table 43: Cascade Abrazo-c-ACT-Product Status 28

Table 44: Cascade Abrazo-c-ACT-Product Description 28

Table 45: Cascade Abrazo-c-ACT-LR-Product Status 29

Table 46: Cascade Abrazo-c-ACT-LR-Product Description 29

Table 47: Cascade Abrazo-Direct Thrombin Inhibitors-Product Status 29

Table 48: Cascade Abrazo-Direct Thrombin Inhibitors-Product Description 30

Table 49: Cascade Abrazo-Fibrinogen-Product Status 30

Table 50: Cascade Abrazo-Fibrinogen-Product Description 30

Table 51: Cascade Abrazo-Heparin Titration-Product Status 31

Table 52: Cascade Abrazo-Heparin Titration-Product Description 31

Table 53: Cascade Abrazo-LMWH-Product Status 31

Table 54: Cascade Abrazo-LMWH-Product Description 32

Table 55: Cascade Abrazo-Protamine Titration-Product Status 32

Table 56: Cascade Abrazo-Protamine Titration-Product Description 32

Table 57: Cascade Abrazo-PT-C-Product Status 33

Table 58: Cascade Abrazo-PT-C-Product Description 33

Table 59: KeenCAT Technologies Pipeline Products & Ongoing Clinical Trials Overview 34

Table 60: HematoCAT-Product Status 34

Table 61: HematoCAT-Product Description 34

Table 62: Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 35

Table 63: Diagnostic Assay-Thrombotic Thrombocytopenic Purpura-Product Status 35

Table 64: Diagnostic Assay-Thrombotic Thrombocytopenic Purpura-Product Description 35

Table 65: PortaScience Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 66: PortaWBC-Product Status 36

Table 67: PortaWBC-Product Description 36

Table 68: Sanguina LLC Pipeline Products & Ongoing Clinical Trials Overview 37

Table 69: AnemoCheck-Product Status 37

Table 70: AnemoCheck-Product Description 37

Table 71: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 38

Table 72: Advia 120 Hematology System-IRF Test-Product Status 38

Table 73: Advia 120 Hematology System-IRF Test-Product Description 39

Table 74: Advia 120 Hematology System-MPC Test-Product Status 39

Table 75: Advia 120 Hematology System-MPC Test-Product Description 39

Table 76: Advia 120 Hematology System-MPM Test-Product Status 40

Table 77: Advia 120 Hematology System-MPM Test-Product Description 40

Table 78: Advia 2120 Hematology System-MPC Test-Product Status 40

Table 79: Advia 2120 Hematology System-MPC Test-Product Description 41

Table 80: Advia 2120 Hematology System-MPM Test-Product Status 41

Table 81: Advia 2120 Hematology System-MPM Test-Product Description 41

Table 82: Advia 2120i Hematology System-MPC Test-Product Status 42

Table 83: Advia 2120i Hematology System-MPC Test-Product Description 42

Table 84: Advia 2120i Hematology System-MPM Test-Product Status 42

Table 85: Advia 2120i Hematology System-MPM Test-Product Description 43

Table 86: T2 Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 87: T2HemoStat-Product Status 44

Table 88: T2HemoStat-Product Description 44

Table 89: T2MR Assay-Platelet Function Testing-Product Status 45

Table 90: T2MR Assay-Platelet Function Testing-Product Description 45

Table 91: The University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 46

Table 92: Thrombin Generation Assay-Product Status 46

Table 93: Thrombin Generation Assay-Product Description 46

Table 94: Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Table 95: Diagnostic Assay-Coagulation-Product Status 47

Table 96: Diagnostic Assay-Coagulation-Product Description 47

Table 97: Glossary 130

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Atomo Diagnostics Pty Limited

BioMedomics Inc

Biosurfit, SA

Carclo Diagnostic Solutions Ltd

Cascade Metrix, Inc.

Correlia Biosystems, Inc.

EKF Diagnostics Holdings Plc

Emosis SAS

ET Healthcare, Inc.

genedrive plc

Helena Laboratories Corp.

KeenCAT Technologies

Ohio State University

PortaScience Inc

Sanguina LLC

Siemens Healthcare GmbH

T2 Biosystems Inc

The University of Melbourne

Universal Biosensors Inc

Atomo Diagnostics Pty Limited, AtomoRapid-Coagulation Monitoring; BioMedomics Inc, Sickle SCAN; Biosurfit, SA, Spinit Device-Blood Quantitation Anemia Assay; Biosurfit, SA, Spinit Device-Thrombocytopenia Assay; Carclo Diagnostic Solutions Ltd, Micropoc-CAT-Haemostasis Assay; Cascade Metrix, Inc., Multiple Blood Analytes Test; Correlia Biosystems, Inc., Electrokinetic Lateral Flow Test; EKF Diagnostics Holdings Plc, Point-Of-Care Test-Coagulation; Emosis SAS, Diagnostic Test Kit-Heparin-Induced Thrombocytopenia; ET Healthcare, Inc., Pylon Assay-D-Dimer; genedrive plc, Genedrive-Factor V Leiden; Helena Laboratories Corp., Cascade Abrazo-APTT; Helena Laboratories Corp., Cascade Abrazo-c-ACT; Helena Laboratories Corp., Cascade Abrazo-c-ACT-LR; Helena Laboratories Corp., Cascade Abrazo-Direct Thrombin Inhibitors; Helena Laboratories Corp., Cascade Abrazo-Fibrinogen; Helena Laboratories Corp., Cascade Abrazo-Heparin Titration; Helena Laboratories Corp., Cascade Abrazo-LMWH; Helena Laboratories Corp., Cascade Abrazo-Protamine Titration; Helena Laboratories Corp., Cascade Abrazo-PT-C; KeenCAT Technologies, HematoCAT; Ohio State University, Diagnostic Assay-Thrombotic Thrombocytopenic Purpura; PortaScience Inc, PortaWBC; Sanguina LLC, AnemoCheck; 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; The University of Melbourne, Thrombin Generation Assay; Universal Biosensors Inc, Diagnostic Assay-Coagulation

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