Troponin Diagnostic Tests - Medical Devices Pipeline Assessment, 2017

Published : Sep-2017

No. of Pages : 60

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 6
2 Introduction 7
2.1 Troponin Diagnostic Tests Overview 7
3 Products under Development 8
3.1 Troponin Diagnostic Tests - Pipeline Products by Stage of Development 8
3.2 Troponin Diagnostic Tests - Pipeline Products by Territory 9
3.3 Troponin Diagnostic Tests - Pipeline Products by Regulatory Path 10
3.4 Troponin Diagnostic Tests - Pipeline Products by Estimated Approval Date 11
4 Troponin Diagnostic Tests - Pipeline Products under Development by Companies 12
4.1 Troponin Diagnostic Tests Companies - Pipeline Products by Stage of Development 12
4.2 Troponin Diagnostic Tests - Pipeline Products by Stage of Development 13
5 Troponin Diagnostic 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 AgPlus Diagnostics LTD Company Overview 21
5.2.1 AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 21
5.3 Akrivis Technologies LLC Company Overview 22
5.3.1 Akrivis Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 22
5.4 Axela Inc Company Overview 23
5.4.1 Axela Inc Pipeline Products & Ongoing Clinical Trials Overview 23
5.5 AXO Science SAS Company Overview 24
5.5.1 AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 24
5.6 Beckman Coulter Inc Company Overview 25
5.6.1 Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 25
5.7 British Heart Foundation Company Overview 26
5.7.1 British Heart Foundation Pipeline Products & Ongoing Clinical Trials Overview 26
5.8 China Medical Technologies Inc (Inactive) Company Overview 27
5.8.1 China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 27
5.9 Fujirebio Diagnostics Inc Company Overview 28
5.9.1 Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 28
5.10 John Hopkins University Company Overview 29
5.10.1 John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 29
5.11 Mindray Medical International Ltd Company Overview 30
5.11.1 Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 30
5.12 Nanosphere Inc Company Overview 31
5.12.1 Nanosphere Inc Pipeline Products & Ongoing Clinical Trials Overview 31
5.13 Orangelife Company Overview 33
5.13.1 Orangelife Pipeline Products & Ongoing Clinical Trials Overview 33
5.14 Ortho-Clinical Diagnostics Inc Company Overview 36
5.14.1 Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 36
5.15 QLIDA Diagnostics Company Overview 38
5.15.1 QLIDA Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 38
5.16 Radiometer Medical ApS Company Overview 39
5.16.1 Radiometer Medical ApS Pipeline Products & Ongoing Clinical Trials Overview 39
5.17 Roche Diagnostics International Ltd Company Overview 40
5.17.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 40
5.18 Siemens Healthcare GmbH Company Overview 44
5.18.1 Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 44
5.19 Singulex Inc Company Overview 49
5.19.1 Singulex Inc Pipeline Products & Ongoing Clinical Trials Overview 49
5.20 Tosoh Bioscience Inc Company Overview 50
5.20.1 Tosoh Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 50
6 Troponin Diagnostic Tests- Recent Developments 51
6.1 Aug 10, 2017: Beckman Coulter Diagnostics Announces Enhancements to the Access 2 Immunoassay System 51
6.2 Aug 01, 2017: Evaluations of the Analytical Performance of the Singulex Cardiac Troponin I Assay Used on its Single Molecule Counting Technology Platform Demonstrates Ability to Improve Cardiovascular Disease Rule-Out 51
6.3 Jun 01, 2017: First ultra-sensitive cardiac troponin (cTnI) test using Single Molecule Counting technology receives CE Mark 52
6.4 Jan 19, 2017: Breakthrough development for Americans with suspected heart attack - Next generation Troponin T test from Roche cleared by FDA 53
6.5 Dec 20, 2016: Singulex Opens European Office and Advances IVD System Evaluation 54
6.6 Dec 19, 2016: Blood test predicts silent heart disease risk 55
7 Appendix 57
7.1 Methodology 57
7.2 About GlobalData 60
7.3 Contact Us 60
7.4 Disclaimer 60

1.1 List of Tables
Table 1: Troponin Diagnostic Tests - Pipeline Products by Stage of Development 8
Table 2: Troponin Diagnostic Tests - Pipeline Products by Territory 9
Table 3: Troponin Diagnostic Tests - Pipeline Products by Regulatory Path 10
Table 4: Troponin Diagnostic Tests - Pipeline Products by Estimated Approval Date 11
Table 5: Troponin Tests Companies - Pipeline Products by Stage of Development 12
Table 6: Troponin Diagnostic Tests - Pipeline Products by Stage of Development 13
Table 7: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 15
Table 8: ARCHITECT c16000 System - High Sensitive Troponin - I Assay - Product Status 15
Table 9: ARCHITECT c16000 System - High Sensitive Troponin - I Assay - Product Description 16
Table 10: ARCHITECT c4000 System - High Sensitive Troponin-I Assay - Product Status 16
Table 11: ARCHITECT c4000 System - High Sensitive Troponin-I Assay - Product Description 16
Table 12: ARCHITECT c8000 System - High Sensitive Troponin-I Assay - Product Status 17
Table 13: ARCHITECT c8000 System - High Sensitive Troponin-I Assay - Product Description 17
Table 14: ARCHITECT ci16200 Integrated System - High Sensitive Troponin-I Assay - Product Status 17
Table 15: ARCHITECT ci16200 Integrated System - High Sensitive Troponin-I Assay - Product Description 18
Table 16: ARCHITECT ci4100 Integrated System - High Sensitive Troponin-I Assay - Product Status 18
Table 17: ARCHITECT ci4100 Integrated System - High Sensitive Troponin-I Assay - Product Description 18
Table 18: ARCHITECT ci8200 Integrated System - High Sensitive Troponin-I Assay - Product Status 19
Table 19: ARCHITECT ci8200 Integrated System - High Sensitive Troponin-I Assay - Product Description 19
Table 20: ARCHITECT i1000SR System - High Sensitive Troponin I Assay - Product Status 19
Table 21: ARCHITECT i1000SR System - High Sensitive Troponin I Assay - Product Description 20
Table 22: ARCHITECT i4000SR Integrated System - High Sensitive Troponin-I Assay - Product Status 20
Table 23: ARCHITECT i4000SR Integrated System - High Sensitive Troponin-I Assay - Product Description 20
Table 24: AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 21
Table 25: AgPlus Diagnostic System - Troponin I Assay - Product Status 21
Table 26: AgPlus Diagnostic System - Troponin I Assay - Product Description 21
Table 27: Akrivis Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 22
Table 28: Z-TECT - cTnI Assay - Product Status 22
Table 29: Z-TECT - cTnI Assay - Product Description 22
Table 30: Axela Inc Pipeline Products & Ongoing Clinical Trials Overview 23
Table 31: Cardiac Troponin Biomarker Kit - Product Status 23
Table 32: Cardiac Troponin Biomarker Kit - Product Description 23
Table 33: AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 24
Table 34: Multiplexed Detection - Troponin - Product Status 24
Table 35: Multiplexed Detection - Troponin - Product Description 24
Table 36: Beckman Coulter Inc Pipeline Products & Ongoing Clinical Trials Overview 25
Table 37: Access 2 Immunoassay System - hsTnI - Product Status 25
Table 38: Access 2 Immunoassay System - hsTnI - Product Description 25
Table 39: British Heart Foundation Pipeline Products & Ongoing Clinical Trials Overview 26
Table 40: Diagnostic Blood Test - Heart Attack - Product Status 26
Table 41: Diagnostic Blood Test - Heart Attack - Product Description 26
Table 42: China Medical Technologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 27
Table 43: Diagnostic Assay - Cardiac Troponin I - Product Status 27
Table 44: Diagnostic Assay - Cardiac Troponin I - Product Description 27
Table 45: Fujirebio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 28
Table 46: Lumipulse G1200 - Troponin I - Product Status 28
Table 47: Lumipulse G1200 - Troponin I - Product Description 28
Table 48: John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 29
Table 49: Cardiac Troponin I Assay - Product Status 29
Table 50: Cardiac Troponin I Assay - Product Description 29
Table 51: Mindray Medical International Ltd Pipeline Products & Ongoing Clinical Trials Overview 30
Table 52: CL-2000i - Troponin I Test - Product Status 30
Table 53: CL-2000i - Troponin I Test - Product Description 30
Table 54: Nanosphere Inc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 55: Ultra-Sensitive Protein Assay - Cardiac Troponin I - Product Status 31
Table 56: Ultra-Sensitive Protein Assay - Cardiac Troponin I - Product Description 31
Table 57: Ultra-Sensitive Protein Assay - Chronic Heart Failure - Product Status 32
Table 58: Ultra-Sensitive Protein Assay - Chronic Heart Failure - Product Description 32
Table 59: Orangelife Pipeline Products & Ongoing Clinical Trials Overview 33
Table 60: OL Quantum Duo Cardio Kit - Product Status 33
Table 61: OL Quantum Duo Cardio Kit - Product Description 33
Table 62: OL Quantum Trio Cardio Kit - Product Status 34
Table 63: OL Quantum Trio Cardio Kit - Product Description 34
Table 64: OL Quantum Troponin I Kit - Product Status 34
Table 65: OL Quantum Troponin I Kit - Product Description 35
Table 66: Ortho-Clinical Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 36
Table 67: Enhanced Chemiluminescent High Sensitivity Troponin I Assay - Product Status 36
Table 68: Enhanced Chemiluminescent High Sensitivity Troponin I Assay - Product Description 36
Table 69: VITROS 3600 - High Sensitivity Troponin Assay - Product Status 37
Table 70: VITROS 3600 - High Sensitivity Troponin Assay - Product Description 37
Table 71: VITROS 5600 - High Sensitivity Troponin Assay - Product Status 37
Table 72: VITROS 5600 - High Sensitivity Troponin Assay - Product Description 37
Table 73: QLIDA Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 38
Table 74: QLIDA - Cardiovascular Disease - Product Status 38
Table 75: QLIDA - Cardiovascular Disease - Product Description 38
Table 76: Radiometer Medical ApS Pipeline Products & Ongoing Clinical Trials Overview 39
Table 77: AQT90 FLEX - TnT Test - Product Status 39
Table 78: AQT90 FLEX - TnT Test - Product Description 39
Table 79: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 40
Table 80: Cobas 4000 Analyzer Series With e 411 Module - High Sensitivity (hs) Troponin T Assay - Product Status 40
Table 81: Cobas 4000 Analyzer Series With e 411 Module - High Sensitivity (hs) Troponin T Assay - Product Description 41
Table 82: Cobas 6000 Analyzer Series With e 601 Module - Troponin T- hs Assay - Product Status 41
Table 83: Cobas 6000 Analyzer Series With e 601 Module - Troponin T- hs Assay - Product Description 41
Table 84: Cobas e 411 Analyzer - Troponin T 5th Generation Assay - Product Status 42
Table 85: Cobas e 411 Analyzer - Troponin T 5th Generation Assay - Product Description 42
Table 86: Elecsys TnT-hs Assay - Product Status 42
Table 87: Elecsys TnT-hs Assay - Product Description 43
Table 88: Siemens Healthcare GmbH Pipeline Products & Ongoing Clinical Trials Overview 44
Table 89: ADVIA Centaur CP Immunoassay System - High-Sensitivity Troponin Assay - Product Status 44
Table 90: ADVIA Centaur CP Immunoassay System - High-Sensitivity Troponin Assay - Product Description 45
Table 91: ADVIA Centaur XPT Immunoassay System - High-Sensitivity Troponin Assay - Product Status 45
Table 92: ADVIA Centaur XPT Immunoassay System - High-Sensitivity Troponin Assay - Product Description 45
Table 93: Dimension EXL 200 Integrated Chemistry System - High-Sensitivity Troponin I Assay - Product Status 46
Table 94: Dimension EXL 200 Integrated Chemistry System - High-Sensitivity Troponin I Assay - Product Description 46
Table 95: Dimension EXL With LM Integrated Chemistry System - LOCI High Sensitivity Troponin Assay - Product Status 46
Table 96: Dimension EXL With LM Integrated Chemistry System - LOCI High Sensitivity Troponin Assay - Product Description 47
Table 97: Dimension Vista 1500 Intelligent Lab System - LOCI High Sensitivity Troponin Assay - Product Status 47
Table 98: Dimension Vista 1500 Intelligent Lab System - LOCI High Sensitivity Troponin Assay - Product Description 47
Table 99: Dimension Vista 500 Intelligent Lab System - LOCI High Sensitivity Troponin Assay - Product Status 48
Table 100: Dimension Vista 500 Intelligent Lab System - LOCI High Sensitivity Troponin Assay - Product Description 48
Table 101: Singulex Inc Pipeline Products & Ongoing Clinical Trials Overview 49
Table 102: Sgx Clarity cTnl Assay - Product Status 49
Table 103: Sgx Clarity cTnl Assay - Product Description 49
Table 104: Tosoh Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 50
Table 105: ST AIA-PACK cTnI-3rd Gen Assay - Product Status 50
Table 106: ST AIA-PACK cTnI-3rd Gen Assay - Product Description 50
Table 107: Glossary 59

1.2 List of Figures
Figure 1: Troponin Diagnostic Tests - Pipeline Products by Stage of Development 8
Figure 2: Troponin Diagnostic Tests - Pipeline Products by Territory 9
Figure 3: Troponin Diagnostic Tests - Pipeline Products by Regulatory Path 10
Figure 4: Troponin Diagnostic Tests - Pipeline Products by Estimated Approval Date 11

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