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

Table of Contents

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

List of Figure

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

List of Table

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