Vitamins Tests - Medical Devices Pipeline Assessment, 2018

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 5

2 Introduction 6

2.1 Vitamins Tests Overview 6

3 Products under Development 7

3.1 Vitamins Tests-Pipeline Products by Stage of Development 7

3.2 Vitamins Tests-Pipeline Products by Segment 8

3.3 Vitamins Tests-Pipeline Products by Territory 9

3.4 Vitamins Tests-Pipeline Products by Regulatory Path 10

3.5 Vitamins Tests-Pipeline Products by Estimated Approval Date 11

4 Vitamins Tests-Pipeline Products under Development by Companies 12

4.1 Vitamins Tests Companies-Pipeline Products by Stage of Development 12

4.2 Vitamins Tests-Pipeline Products by Stage of Development 13

5 Vitamins Tests Companies and Product Overview 14

5.1 Adaltis S.r.l. Company Overview 14

5.1.1 Adaltis S.r.l. Pipeline Products & Ongoing Clinical Trials Overview 14

5.2 Beckman Coulter Inc Company Overview 16

5.2.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 16

5.3 bioMerieux SA Company Overview 18

5.3.1 bioMerieux SA Pipeline Products & Ongoing Clinical Trials Overview 18

5.4 Boditech Med Inc Company Overview 19

5.4.1 Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 19

5.5 EKF Diagnostics Holdings Plc Company Overview 20

5.5.1 EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 20

5.6 Genesis Detection Systems, Inc. Company Overview 21

5.6.1 Genesis Detection Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21

5.7 Infigo Diagnostics Ltd (Inactive) Company Overview 22

5.7.1 Infigo Diagnostics Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 22

5.8 Mindray Medical International Ltd Company Overview 23

5.8.1 Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

5.9 MyHealthTest Pty Ltd Company Overview 25

5.9.1 MyHealthTest Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

5.10 Roche Diagnostics International Ltd Company Overview 26

5.10.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

5.11 Siemens Healthcare GmbH Company Overview 31

5.11.1 Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 31

5.12 University of Colorado Company Overview 33

5.12.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 33

6 Vitamins Tests- Recent Developments 34

6.1 Apr 27, 2018: Anteo Diagnostics: Activities Report-Quarter Ended 31 March 2018 34

6.2 Apr 09, 2018: Anteo Diagnostics: CEO Resignation and CEO Appointment 36

6.3 Apr 03, 2018: Anteo Diagnostics: Chairman Appointed and Board Changes 36

6.4 Jan 31, 2018: Activities Report-Quarter Ended 31 December 2017 37

6.5 Dec 06, 2017: Anteo Diagnostics: Appointment of Chief Executive Officer 39

6.6 Oct 31, 2017: Anteo Diagnostics: Activities Report-Quarter Ended 30 September 2017 40

6.7 Sep 01, 2017: Management changes resulting from sale of DIAsource 43

6.8 Sep 01, 2017: Anteo Diagnostics: 30 June 2017 Preliminary Financial Statements 43

6.9 Aug 10, 2017: Beckman Coulter Diagnostics Announces Enhancements to the Access 2 Immunoassay System 44

7 Appendix 46

7.1 Methodology 46

7.2 About GlobalData 49

7.3 Contact Us 49

7.4 Disclaimer 49

List Of Figure

1.2 List of Figures

Figure 1: Vitamins Tests-Pipeline Products by Stage of Development 7

Figure 2: Vitamins Tests-Pipeline Products by Segment 8

Figure 3: Vitamins Tests-Pipeline Products by Territory 9

Figure 4: Vitamins Tests-Pipeline Products by Regulatory Path 10

Figure 5: Vitamins Tests-Pipeline Products by Estimated Approval Date 11

List Of Table

1.1 List of Tables

Table 1: Vitamins Tests-Pipeline Products by Stage of Development 7

Table 2: Vitamins Tests-Pipeline Products by Segment 8

Table 3: Vitamins Tests-Pipeline Products by Territory 9

Table 4: Vitamins Tests-Pipeline Products by Regulatory Path 10

Table 5: Vitamins Tests-Pipeline Products by Estimated Approval Date 11

Table 6: Vitamins Tests Companies-Pipeline Products by Stage of Development 12

Table 7: Vitamins Tests-Pipeline Products by Stage of Development 13

Table 8: Adaltis S.r.l. Pipeline Products & Ongoing Clinical Trials Overview 14

Table 9: Hemo One-Folic Acid Assay-Product Status 14

Table 10: Hemo One-Folic Acid Assay-Product Description 14

Table 11: Hemo One-Vitamin B12 Assay-Product Status 15

Table 12: Hemo One-Vitamin B12 Assay-Product Description 15

Table 13: Hemo One-Vitamin D Assay-Product Status 15

Table 14: Hemo One-Vitamin D Assay-Product Description 15

Table 15: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 16

Table 16: Access 2 Immunoassay System-Active B12-Product Status 16

Table 17: Access 2 Immunoassay System-Active B12-Product Description 16

Table 18: UniCel DxI 600 Access Immunoassay System-Active B12 Assay-Product Status 17

Table 19: UniCel DxI 600 Access Immunoassay System-Active B12 Assay-Product Description 17

Table 20: UniCel DxI 800 Access Immunoassay System-Active B12 Assay-Product Status 17

Table 21: UniCel DxI 800 Access Immunoassay System-Active B12 Assay-Product Description 17

Table 22: bioMerieux SA Pipeline Products & Ongoing Clinical Trials Overview 18

Table 23: VIDAS-Vitamin D Test-Product Status 18

Table 24: VIDAS-Vitamin D Test-Product Description 18

Table 25: Boditech Med Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 26: AFIAS-6 Vitamin D Assay-Product Status 19

Table 27: AFIAS-6 Vitamin D Assay-Product Description 19

Table 28: EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 20

Table 29: Point-Of-Care Test-Vitamin D Test-Product Status 20

Table 30: Point-Of-Care Test-Vitamin D Test-Product Description 20

Table 31: Genesis Detection Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21

Table 32: Rapid Home Test-Vitamin And Mineral Deficiency-Product Status 21

Table 33: Rapid Home Test-Vitamin And Mineral Deficiency-Product Description 21

Table 34: Infigo Diagnostics Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 22

Table 35: MIPdx-B12-Product Status 22

Table 36: MIPdx-B12-Product Description 22

Table 37: Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Table 38: CL-1000i-Vitamin B12 Test-Product Status 23

Table 39: CL-1000i-Vitamin B12 Test-Product Description 23

Table 40: CL-2000i-Vitamin B12 Test-Product Status 24

Table 41: CL-2000i-Vitamin B12 Test-Product Description 24

Table 42: MyHealthTest Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

Table 43: Diagnostic Test-Vitamins-Product Status 25

Table 44: Diagnostic Test-Vitamins-Product Description 25

Table 45: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

Table 46: Cobas 6000 Analyzer Series With c 501 Module-Holo TC Assay-Product Status 26

Table 47: Cobas 6000 Analyzer Series With c 501 Module-Holo TC Assay-Product Description 27

Table 48: Cobas 6000 Analyzer Series With e 601 Module-Holo TC Assay-Product Status 27

Table 49: Cobas 6000 Analyzer Series With e 601 Module-Holo TC Assay-Product Description 27

Table 50: Cobas 8000 Analyzer Series-Holo TC Assay-Product Status 27

Table 51: Cobas 8000 Analyzer Series-Holo TC Assay-Product Description 28

Table 52: Cobas 8000 Analyzer Series With c 502 Module-Holo TC Assay-Product Status 28

Table 53: Cobas 8000 Analyzer Series With c 502 Module-Holo TC Assay-Product Description 28

Table 54: Cobas 8000 Analyzer Series With c 701 Module-Holo TC Assay-Product Status 28

Table 55: Cobas 8000 Analyzer Series With c 701 Module-Holo TC Assay-Product Description 29

Table 56: Cobas 8000 Analyzer Series With c 702 Module-Holo TC Assay-Product Status 29

Table 57: Cobas 8000 Analyzer Series With c 702 Module-Holo TC Assay-Product Description 29

Table 58: Cobas 8000 Analyzer Series With e 602 Module-Holo TC Assay-Product Status 29

Table 59: Cobas 8000 Analyzer Series With e 602 Module-Holo TC Assay-Product Description 30

Table 60: Cobas 8000 Analyzer Series With e 801 Module-Active B 12 Assay-Product Status 30

Table 61: Cobas 8000 Analyzer Series With e 801 Module-Active B 12 Assay-Product Description 30

Table 62: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 31

Table 63: ADVIA Centaur CP Immunoassay System-Active B12 Assay-Product Status 31

Table 64: ADVIA Centaur CP Immunoassay System-Active B12 Assay-Product Description 31

Table 65: Dimension EXL System-LOCI B12 Assay-Product Status 32

Table 66: Dimension EXL System-LOCI B12 Assay-Product Description 32

Table 67: University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 33

Table 68: Sulfhydryl Amino-acid Assay-Product Status 33

Table 69: Sulfhydryl Amino-acid Assay-Product Description 33

Table 70: Glossary 48

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