Thyroid Function Tests - Medical Devices Pipeline Assessment, 2017

Published : Aug-2017

No. of Pages : 135

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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 Thyroid Function Tests Overview 7
3 Products under Development 8
3.1 Thyroid Function Tests - Pipeline Products by Stage of Development 8
3.2 Thyroid Function Tests - Pipeline Products by Segment 9
3.3 Thyroid Function Tests - Pipeline Products by Territory 10
3.4 Thyroid Function Tests - Pipeline Products by Regulatory Path 11
3.5 Thyroid Function Tests - Pipeline Products by Estimated Approval Date 12
4 Thyroid Function Tests - Pipeline Products under Development by Companies 13
4.1 Thyroid Function Tests Companies - Pipeline Products by Stage of Development 13
4.2 Thyroid Function Tests - Pipeline Products by Stage of Development 14
5 Thyroid Function Tests Companies and Product Overview 15
5.1 Abbott Diagnostics Company Overview 15
5.1.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 15
5.2 Achira Labs Pvt Ltd Company Overview 16
5.2.1 Achira Labs Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 16
5.3 AXO Science SAS Company Overview 17
5.3.1 AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 17
5.4 GeneFluidics Inc Company Overview 18
5.4.1 GeneFluidics Inc Pipeline Products & Ongoing Clinical Trials Overview 18
5.5 Immunodiagnostic Systems Holdings plc Company Overview 21
5.5.1 Immunodiagnostic Systems Holdings plc Pipeline Products & Ongoing Clinical Trials Overview 21
5.6 MedMira Inc. Company Overview 22
5.6.1 MedMira Inc. Pipeline Products & Ongoing Clinical Trials Overview 22
5.7 Mindray Medical International Ltd Company Overview 23
5.7.1 Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
5.8 Novartis AG Company Overview 25
5.8.1 Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 25
5.9 Ohmx Corp Company Overview 26
5.9.1 Ohmx Corp Pipeline Products & Ongoing Clinical Trials Overview 26
5.10 Ortho-Clinical Diagnostics Inc Company Overview 27
5.10.1 Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 27
5.11 Protagen AG Company Overview 28
5.11.1 Protagen AG Pipeline Products & Ongoing Clinical Trials Overview 28
5.12 Quidel Corp Company Overview 29
5.12.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 29
5.13 Siemens Healthcare GmbH Company Overview 31
5.13.1 Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 31
5.14 Sysmex Corp Company Overview 37
5.14.1 Sysmex Corp Pipeline Products & Ongoing Clinical Trials Overview 37
5.15 Toshiba Medical Systems Corporation Company Overview 40
5.15.1 Toshiba Medical Systems Corporation Pipeline Products & Ongoing Clinical Trials Overview 40
5.16 True Diagnostics Inc Company Overview 41
5.16.1 True Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 41
5.17 University Rovira i Virgili Company Overview 43
5.17.1 University Rovira i Virgili Pipeline Products & Ongoing Clinical Trials Overview 43
6 Thyroid Function Tests- Recent Developments 44
6.1 Jul 26, 2017: Thermo Fisher Scientific Reports Second Quarter 2017 Results 44
6.2 Jul 20, 2017: bioMerieux - Second-Quarter 2017 Business Review 45
6.3 Jul 20, 2017: Abbott Reports Second-Quarter 2017 Results 48
6.4 Jul 18, 2017: Q2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative products 50
6.5 Jul 06, 2017: Kurt H. Kruger joins Qualigen's Board of Directors 56
6.6 Jul 06, 2017: Richard David, MD, FACS joins Qualigen's Board of Directors 56
6.7 Jun 29, 2017: MedMira Reports FY2017 Third Quarter Results 57
6.8 Jun 21, 2017: Immunodiagnostic Systems Holdings: Final Results for year ended 31 March 2017 57
6.9 Jun 07, 2017: Quidel Receives the CE Mark for Its Thyretain TBI Reporter BioAssay 58
6.10 May 16, 2017: NOWDiagnostics CEO Kevin Clark to Address Technology Conference 58
6.11 May 08, 2017: Dr. Stephen S. Lane joins Alcon as Chief Medical Officer and Global Head Franchise Clinical Strategy 59
6.12 May 04, 2017: PerkinElmer Announces Financial Results for the First Quarter of 2017 60
6.13 May 03, 2017: Veracyte Announces First Quarter 2017 Financial Results 61
6.14 Apr 26, 2017: Thermo Fisher Scientific Reports First Quarter 2017 Results 62
6.15 Apr 25, 2017: Novartis delivered sales growth across all divisions as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued 63
6.16 Apr 20, 2017: bioMerieux - First-Quarter 2017 Business Review 68
6.17 Apr 19, 2017: Abbott Reports First-Quarter 2017 Results 70
6.18 Apr 17, 2017: Toshiba Medical Names Dan Skyba Director of Ultrasound Business Unit 73
6.19 Mar 31, 2017: MedMira Reports FY2017 Second Quarter Results 73
6.20 Mar 23, 2017: PerkinElmer to Display Portfolio of Cancer Research Technologies and Workflow Solutions at 2017 AACR Annual Meeting 73
6.21 Mar 13, 2017: Immunodiagnostic Systems Holdings Re-Appoints CEO 75
6.22 Mar 01, 2017: Thermo Fisher Scientific Elects New Director to Board 75
6.23 Mar 01, 2017: Veracyte Announces Fourth Quarter and Full-Year 2016 Financial Results, Provides 2017 Financial Outlook 76
6.24 Feb 28, 2017: Veracyte Announces Executive Promotions 77
6.25 Feb 28, 2017: Novartis shareholders approve all resolutions proposed by Board of Directors at the Annual General Meeting 77
6.26 Feb 24, 2017: Immunodiagnostic Systems Holdings: Update on CEO Appointment 78
6.27 Feb 02, 2017: PerkinElmer Announces Financial Results for Fourth Quarter and Full Year 2016 78
6.28 Jan 31, 2017: Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2016 Results 80
6.29 Jan 30, 2017: MedMira Announces AGM Results and Stock Option Grant 82
6.30 Jan 27, 2017: Omega Diagnostics Group: Update on discussions with Immunodiagnostic Systems Holdings 83
6.31 Jan 26, 2017: Novartis highlights progress towards access and environmental goals in 2016 Corporate Responsibility Performance Report 83
6.32 Jan 26, 2017: Achievement of sales milestone for COPD products 84
6.33 Jan 25, 2017: Novartis delivered solid 2016 performance, with Growth Products absorbing Gleevec US LOE; innovation momentum continued; announces share buyback 84
6.34 Jan 23, 2017: ISO 17025 Accreditation for Microbiology Manufacturing Site Offers Increased Confidence to Microbiology Testing Laboratories 92
6.35 Jan 19, 2017: bioMerieux - Fourth-Quarter 2016 Business Review 92
6.36 Jan 19, 2017: Immunodiagnostic Systems Holdings Announces Directorate Change 94
6.37 Dec 30, 2016: MedMira Reports 2017 First Quarter Financial Results 95
6.38 Dec 14, 2016: Beckman Coulter appoints IT Product Manager for Northern Europe 95
6.39 Dec 13, 2016: Veracyte Announces Appointment of Kevin K. Gordon and Other Changes to Its Board of Directors 96
6.40 Nov 29, 2016: Novartis Access shares one-year learnings and announces memorandum of understanding with Rwanda 97
6.41 Nov 28, 2016: MedMira Reports 2016 Fourth Quarter and Year End Financial Results 98
6.42 Nov 25, 2016: Immunodiagnostic Systems Holdings: Interim Results for the six month period ended 30 September 2016 98
6.43 Nov 21, 2016: Veracyte appoints new CFO 99
6.44 Nov 10, 2016: Diasorin Group Reports Continued Growth In Revenues And Profitability In The Third Quarter 2016 99
6.45 Nov 07, 2016: PerkinElmer Announces Financial Results for the Third Quarter of 2016 100
6.46 Nov 07, 2016: Pierre Boulud appointed Corporate Vice Presidentof the Asia Pacific region at bioMerieux 101
6.47 Nov 03, 2016: Veracyte Announces Third Quarter 2016 Financial Results 102
6.48 Oct 27, 2016: Thermo Fisher Scientific Reports Third Quarter 2016 Results 103
6.49 Oct 25, 2016: Novartis delivered solid third quarter with Growth Products offsetting Gleevec patent expiration; several positive readouts for potential blockbusters 104
6.50 Oct 21, 2016: Immunodiagnostic Systems Holdings: H1 Trading Update 111
6.51 Oct 20, 2016: bioMerieux-Business Review for the nine months ended September 30, 2016 112
6.52 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results 115
6.53 Oct 17, 2016: Veracyte Releases Preliminary Third Quarter 2016 Financial Results 118
6.54 Oct 17, 2016: PerkinElmer Elects Samuel Chapin to Board of Directors 118
6.55 Sep 26, 2016: PerkinElmer Announces New Organizational Structure 119
6.56 Aug 31, 2016: bioMerieux - First-Half 2016 Results 119
6.57 Aug 09, 2016: Ortho Clinical Diagnostics Featured in Clinical Lab Products 123
6.58 Aug 04, 2016: PerkinElmer Announces Financial Results for the Second Quarter of 2016 124
6.59 Aug 04, 2016: Diasorin Group Revenues And EBITDA Reached Record highs In the Second Quarter 2016 125
6.60 Aug 03, 2016: Veracyte Announces Second Quarter 2016 Financial Results 129
6.61 Aug 01, 2016: Thermo Fisher Scientific Expands Offering for Clinical Applications at AACC 2016 130
6.62 Aug 01, 2016: Thermo Fisher Scientific Receives FDA Clearance for EliA Anti-Thyroglobulin and Anti-Thyroid Peroxidase Tests for Autoimmune Thyroid Disease 131
7 Appendix 132
7.1 Methodology 132
7.2 About GlobalData 135
7.3 Contact Us 135
7.4 Disclaimer 135

1.1 List of Tables
Table 1: Thyroid Function Tests - Pipeline Products by Stage of Development 8
Table 2: Thyroid Function Tests - Pipeline Products by Segment 9
Table 3: Thyroid Function Tests - Pipeline Products by Territory 10
Table 4: Thyroid Function Tests - Pipeline Products by Regulatory Path 11
Table 5: Thyroid Function Tests - Pipeline Products by Estimated Approval Date 12
Table 6: Thyroid Function Tests Companies - Pipeline Products by Stage of Development 13
Table 7: Thyroid Function Tests - Pipeline Products by Stage of Development 14
Table 8: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 15
Table 9: Alinity ci - Thyroid Disease - Product Status 15
Table 10: Alinity ci - Thyroid Disease - Product Description 15
Table 11: Achira Labs Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 16
Table 12: TSH Diagnostic Panel - Product Status 16
Table 13: TSH Diagnostic Panel - Product Description 16
Table 14: AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 17
Table 15: Multiplexed Detection - TSH - Product Status 17
Table 16: Multiplexed Detection - TSH - Product Description 17
Table 17: GeneFluidics Inc Pipeline Products & Ongoing Clinical Trials Overview 18
Table 18: Free T3 Assay - Product Status 18
Table 19: Free T3 Assay - Product Description 18
Table 20: Free T4 Assay - Product Status 19
Table 21: Free T4 Assay - Product Description 19
Table 22: T3 Assay - Product Status 19
Table 23: T3 Assay - Product Description 20
Table 24: T4 Assay - Product Status 20
Table 25: T4 Assay - Product Description 20
Table 26: Immunodiagnostic Systems Holdings plc Pipeline Products & Ongoing Clinical Trials Overview 21
Table 27: IDS-iSYS Bioactive PTH (1-84) Kit - Product Status 21
Table 28: IDS-iSYS Bioactive PTH (1-84) Kit - Product Description 21
Table 29: MedMira Inc. Pipeline Products & Ongoing Clinical Trials Overview 22
Table 30: Reveal TSH Single Test - Product Status 22
Table 31: Reveal TSH Single Test - Product Description 22
Table 32: Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
Table 33: CL-2000i - Anti-TG Test - Product Status 23
Table 34: CL-2000i - Anti-TG Test - Product Description 23
Table 35: CL-2000i - Anti-TPO - Product Status 24
Table 36: CL-2000i - Anti-TPO - Product Description 24
Table 37: CL-2000i - Thyroglobulin (TG) Test - Product Status 24
Table 38: CL-2000i - Thyroglobulin (TG) Test - Product Description 24
Table 39: Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 25
Table 40: Diagnostic Test - Thyroid Stimulating Hormone - Product Status 25
Table 41: Diagnostic Test - Thyroid Stimulating Hormone - Product Description 25
Table 42: Ohmx Corp Pipeline Products & Ongoing Clinical Trials Overview 26
Table 43: Portable POC System - Thyroid Stimulating Hormone - Product Status 26
Table 44: Portable POC System - Thyroid Stimulating Hormone - Product Description 26
Table 45: Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 27
Table 46: Diagnostic Assay - Thyroid Diseases - Product Status 27
Table 47: Diagnostic Assay - Thyroid Diseases - Product Description 27
Table 48: Protagen AG Pipeline Products & Ongoing Clinical Trials Overview 28
Table 49: Diagnostic Assay - Thyroid Disease - Product Status 28
Table 50: Diagnostic Assay - Thyroid Disease - Product Description 28
Table 51: Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 29
Table 52: Sofia - Thyroid Stimulating Hormone - Product Status 29
Table 53: Sofia - Thyroid Stimulating Hormone - Product Description 29
Table 54: Thyretain TBI Reporter BioAssay - Product Status 30
Table 55: Thyretain TBI Reporter BioAssay - Product Description 30
Table 56: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 31
Table 57: ADVIA Centaur CP Immunoassay System - Tg Assay - Product Status 31
Table 58: ADVIA Centaur CP Immunoassay System - Tg Assay - Product Description 32
Table 59: ADVIA Centaur XP Immunoassay System - Tg Assay - Product Status 32
Table 60: ADVIA Centaur XP Immunoassay System - Tg Assay - Product Description 32
Table 61: ADVIA Centaur XPT Immunoassay System - Tg Assay - Product Status 33
Table 62: ADVIA Centaur XPT Immunoassay System - Tg Assay - Product Description 33
Table 63: Dimension Vista 1000T Intelligent Lab System - Intact PTH Assay - Product Status 33
Table 64: Dimension Vista 1000T Intelligent Lab System - Intact PTH Assay - Product Description 34
Table 65: Dimension Vista 1500 Intelligent Lab System - Intact PTH Assay - Product Status 34
Table 66: Dimension Vista 1500 Intelligent Lab System - Intact PTH Assay - Product Description 34
Table 67: Dimension Vista 3000T Intelligent Lab System - Intact PTH Assay - Product Status 35
Table 68: Dimension Vista 3000T Intelligent Lab System - Intact PTH Assay - Product Description 35
Table 69: Dimension Vista 500 Intelligent Lab System - Intact PTH Assay - Product Status 35
Table 70: Dimension Vista 500 Intelligent Lab System - Intact PTH Assay - Product Description 35
Table 71: IMMULITE 1000 Immunoassay System - TSI Assay - Product Status 36
Table 72: IMMULITE 1000 Immunoassay System - TSI Assay - Product Description 36
Table 73: Sysmex Corp Pipeline Products & Ongoing Clinical Trials Overview 37
Table 74: Immunochemistry Test - Tg Ab - Product Status 37
Table 75: Immunochemistry Test - Tg Ab - Product Description 37
Table 76: Immunochemistry Test - TPO Ab - Product Status 38
Table 77: Immunochemistry Test - TPO Ab - Product Description 38
Table 78: Immunochemistry Test - TR Ab - Product Status 38
Table 79: Immunochemistry Test - TR Ab - Product Description 39
Table 80: Toshiba Medical Systems Corporation Pipeline Products & Ongoing Clinical Trials Overview 40
Table 81: Diagnostic Test - Thyroid Disorders - Product Status 40
Table 82: Diagnostic Test - Thyroid Disorders - Product Description 40
Table 83: True Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 84: TrueDX - Thyroid Health - Product Status 41
Table 85: TrueDX - Thyroid Health - Product Description 41
Table 86: TrueDX - TSH Test - Product Status 42
Table 87: TrueDX - TSH Test - Product Description 42
Table 88: University Rovira i Virgili Pipeline Products & Ongoing Clinical Trials Overview 43
Table 89: CD-Medics Test - Thyroiditis - Product Status 43
Table 90: CD-Medics Test - Thyroiditis - Product Description 43
Table 91: Glossary 134

1.2 List of Figures
Figure 1: Thyroid Function Tests - Pipeline Products by Stage of Development 8
Figure 2: Thyroid Function Tests - Pipeline Products by Segment 9
Figure 3: Thyroid Function Tests - Pipeline Products by Territory 10
Figure 4: Thyroid Function Tests - Pipeline Products by Regulatory Path 11
Figure 5: Thyroid Function Tests - Pipeline Products by Estimated Approval Date 12

Filed in: Medical Device

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