Point-of-Care POC Analyzers-Medical Devices Pipeline Assessment, 2016

Point-of-Care POC Analyzers-Medical Devices Pipeline Assessment, 2016


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Executive Summary

Point-of-Care (POC) Analyzers-Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Point-of-Care (POC) Analyzers-Medical Devices Pipeline Assessment, 2016" provides an overview of Point-of-Care (POC) Analyzers 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 Point-of-Care (POC) Analyzers 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 Point-of-Care (POC) Analyzers 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 Point-of-Care (POC) Analyzers 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 Point-of-Care (POC) Analyzers 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 4

1.2 List of Figures 6

2 Introduction 7

2.1 Point-of-Care (POC) Analyzers Overview 7

3 Products under Development 8

3.1 Point-of-Care (POC) Analyzers-Pipeline Products by Stage of Development 8

3.2 Point-of-Care (POC) Analyzers-Pipeline Products by Territory 9

3.3 Point-of-Care (POC) Analyzers-Pipeline Products by Regulatory Path 10

3.4 Point-of-Care (POC) Analyzers-Pipeline Products by Estimated Approval Date 11

4 Point-of-Care (POC) Analyzers-Pipeline Products under Development by Companies 12

4.1 Point-of-Care (POC) Analyzers Companies-Pipeline Products by Stage of Development 12

4.2 Point-of-Care (POC) Analyzers-Pipeline Products by Stage of Development 14

5 Point-of-Care (POC) Analyzers Companies and Product Overview 16

5.1 Akers Biosciences, Inc. Company Overview 16

5.1.1 Akers Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 16

5.2 Akonni Biosystems, Inc. Company Overview 18

5.2.1 Akonni Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18

5.3 ApoCell, Inc. Company Overview 19

5.3.1 ApoCell, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19

5.4 Attophotonics Biosciences GmbH Company Overview 20

5.4.1 Attophotonics Biosciences GmbH Pipeline Products & Ongoing Clinical Trials Overview 20

5.5 Bio-Alternative Medical Devices Ltd Company Overview 21

5.5.1 Bio-Alternative Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

5.6 BioDirection, Inc. Company Overview 23

5.6.1 BioDirection, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23

5.7 BioMedomics, Inc Company Overview 24

5.7.1 BioMedomics, Inc Pipeline Products & Ongoing Clinical Trials Overview 24

5.8 bioMerieux S.A. Company Overview 26

5.8.1 bioMerieux S.A. Pipeline Products & Ongoing Clinical Trials Overview 26

5.9 Biopico Systems Inc. Company Overview 28

5.9.1 Biopico Systems Inc. Pipeline Products & Ongoing Clinical Trials Overview 28

5.10 Boston University Company Overview 29

5.10.1 Boston University Pipeline Products & Ongoing Clinical Trials Overview 29

5.11 Cepheid Company Overview 31

5.11.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 31

5.12 Co-Diagnostics HBDC, Inc. Company Overview 34

5.12.1 Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34

5.13 Indian Institute of Technology, Madras Company Overview 35

5.13.1 Indian Institute of Technology, Madras Pipeline Products & Ongoing Clinical Trials Overview 35

5.14 John Hopkins University Company Overview 36

5.14.1 John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 36

5.15 Magna Diagnostics GmbH Company Overview 38

5.15.1 Magna Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 38

5.16 McKesson Corporation Company Overview 39

5.16.1 McKesson Corporation Pipeline Products & Ongoing Clinical Trials Overview 39

5.17 Nanomix, Inc. Company Overview 41

5.17.1 Nanomix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41

5.18 OncoGenesis Company Overview 42

5.18.1 OncoGenesis Pipeline Products & Ongoing Clinical Trials Overview 42

5.19 Phoenix Biosystems Inc Company Overview 43

5.19.1 Phoenix Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.20 PositiveID Corporation Company Overview 44

5.20.1 PositiveID Corporation Pipeline Products & Ongoing Clinical Trials Overview 44

5.21 Quanterix Corporation Company Overview 46

5.21.1 Quanterix Corporation Pipeline Products & Ongoing Clinical Trials Overview 46

5.22 Radisens Diagnostics Limited Company Overview 48

5.22.1 Radisens Diagnostics Limited Pipeline Products & Ongoing Clinical Trials Overview 48

5.23 Rapid Biosensor Systems Company Overview 50

5.23.1 Rapid Biosensor Systems Pipeline Products & Ongoing Clinical Trials Overview 50

5.24 SenGenix, Inc. Company Overview 51

5.24.1 SenGenix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

5.25 Thermal Gradient, Inc. Company Overview 52

5.25.1 Thermal Gradient, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

5.26 University of Alberta Company Overview 54

5.26.1 University of Alberta Pipeline Products & Ongoing Clinical Trials Overview 54

5.27 University of California, Berkeley Company Overview 55

5.27.1 University of California, Berkeley Pipeline Products & Ongoing Clinical Trials Overview 55

5.28 University of California, Davis Company Overview 57

5.28.1 University of California, Davis Pipeline Products & Ongoing Clinical Trials Overview 57

5.29 Wellstat Diagnostics, LLC Company Overview 58

5.29.1 Wellstat Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 58

5.30 Xen Biofluidx Inc Company Overview 59

5.30.1 Xen Biofluidx Inc Pipeline Products & Ongoing Clinical Trials Overview 59

6 Point-of-Care (POC) Analyzers-Recent Developments 60

6.1 Jun 29, 2016: McKesson Updates Fiscal 2017 Guidance 60

6.2 May 25, 2016: Thermal Gradient Performs 13 Minute MRSA Test 60

6.3 Dec 03, 2015: Cepheid Enters into Agreement with Foundation for Innovative New Diagnostics 60

7 Appendix 61

7.1 Methodology 61

7.2 About GlobalData 63

7.3 Contact Us 64

7.4 Disclaimer 64

1.2 List of Figures

Figure 1: Point-of-Care (POC) Analyzers-Pipeline Products by Stage of Development 8

Figure 2: Point-of-Care (POC) Analyzers-Pipeline Products by Territory 9

Figure 3: Point-of-Care (POC) Analyzers-Pipeline Products by Regulatory Path 10

Figure 4: Point-of-Care (POC) Analyzers-Pipeline Products by Estimated Approval Date 11

1.1 List of Tables

Table 1: Point-of-Care (POC) Analyzers-Pipeline Products by Stage of Development 8

Table 2: Point-of-Care (POC) Analyzers-Pipeline Products by Territory 9

Table 3: Point-of-Care (POC) Analyzers-Pipeline Products by Regulatory Path 10

Table 4: Point-of-Care (POC) Analyzers-Pipeline Products by Estimated Approval Date 11

Table 5: Point-of-Care (POC) Analyzers Companies-Pipeline Products by Stage of Development 12

Table 6: Point-of-Care (POC) Analyzers-Pipeline Products by Stage of Development 14

Table 7: Akers Biosciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 16

Table 8: minDNAnalyzer-Product Status 16

Table 9: minDNAnalyzer-Product Description 17

Table 10: Akonni Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18

Table 11: Point-Of-Care Device-Tuberculosis-Product Status 18

Table 12: Point-Of-Care Device-Tuberculosis-Product Description 18

Table 13: ApoCell, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19

Table 14: ApoStream System-Product Status 19

Table 15: ApoStream System-Product Description 19

Table 16: Attophotonics Biosciences GmbH Pipeline Products & Ongoing Clinical Trials Overview 20

Table 17: Nanoparticle Microfluidic Color Device-Product Status 20

Table 18: Nanoparticle Microfluidic Color Device-Product Description 20

Table 19: Bio-Alternative Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

Table 20: Magnetic Immunoassay Detection System-Product Status 21

Table 21: Magnetic Immunoassay Detection System-Product Description 22

Table 22: BioDirection, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23

Table 23: Tbit Hand-held System-Product Status 23

Table 24: Tbit Hand-held System-Product Description 23

Table 25: BioMedomics, Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Table 26: Next Generation Ultra-sensitive Nanotube Platform-Product Status 24

Table 27: Next Generation Ultra-sensitive Nanotube Platform-Product Description 25

Table 28: TR-LFIA Diagnostic Platform-Product Status 25

Table 29: TR-LFIA Diagnostic Platform-Product Description 25

Table 30: bioMerieux S.A. Pipeline Products & Ongoing Clinical Trials Overview 26

Table 31: Magnotech System-Product Status 26

Table 32: Magnotech System-Product Description 27

Table 33: Biopico Systems Inc. Pipeline Products & Ongoing Clinical Trials Overview 28

Table 34: MONITOR System-Product Status 28

Table 35: MONITOR System-Product Description 28

Table 36: Boston University Pipeline Products & Ongoing Clinical Trials Overview 29

Table 37: Molecular Diagnostic Device-Sexually Transmitted Infections-Product Status 29

Table 38: Molecular Diagnostic Device-Sexually Transmitted Infections-Product Description 30

Table 39: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 31

Table 40: GeneXpert Omni-Product Status 31

Table 41: GeneXpert Omni-Product Description 32

Table 42: GeneXpert Omni CLIA-Waived Point-of-Care System-Product Status 32

Table 43: GeneXpert Omni CLIA-Waived Point-of-Care System-Product Description 33

Table 44: Co-Diagnostics HBDC, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34

Table 45: LightPCR-Product Status 34

Table 46: LightPCR-Product Description 34

Table 47: Indian Institute of Technology, Madras Pipeline Products & Ongoing Clinical Trials Overview 35

Table 48: Microfluidic Flow Analyzer-Product Status 35

Table 49: Microfluidic Flow Analyzer-Product Description 35

Table 50: John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 36

Table 51: Point-Of-Care Sensor-Brain Injury-Product Status 36

Table 52: Point-Of-Care Sensor-Brain Injury-Product Description 37

Table 53: Magna Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 38

Table 54: MAZER System-Product Status 38

Table 55: MAZER System-Product Description 38

Table 56: McKesson Corporation Pipeline Products & Ongoing Clinical Trials Overview 39

Table 57: Proventys PDx System-Product Status 39

Table 58: Proventys PDx System-Product Description 40

Table 59: Nanomix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41

Table 60: Nanomix System-Ebola Virus-Product Status 41

Table 61: Nanomix System-Ebola Virus-Product Description 41

Table 62: OncoGenesis Pipeline Products & Ongoing Clinical Trials Overview 42

Table 63: Genesis Point-Of-Care Diagnostic System-Product Status 42

Table 64: Genesis Point-Of-Care Diagnostic System-Product Description 42

Table 65: Phoenix Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 66: Point of Care HIV Combo Device-Product Status 43

Table 67: Point of Care HIV Combo Device-Product Description 43

Table 68: PositiveID Corporation Pipeline Products & Ongoing Clinical Trials Overview 44

Table 69: Firefly Dx System-Zika Virus-Product Status 44

Table 70: Firefly Dx System-Zika Virus-Product Description 45

Table 71: Quanterix Corporation Pipeline Products & Ongoing Clinical Trials Overview 46

Table 72: POC Device-Neurological Injuries-Product Status 46

Table 73: POC Device-Neurological Injuries-Product Description 46

Table 74: Simoa 5.0-Product Status 47

Table 75: Simoa 5.0-Product Description 47

Table 76: Radisens Diagnostics Limited Pipeline Products & Ongoing Clinical Trials Overview 48

Table 77: Radisens Instrument-Product Status 48

Table 78: Radisens Instrument-Product Description 49

Table 79: Rapid Biosensor Systems Pipeline Products & Ongoing Clinical Trials Overview 50

Table 80: Rapid Test Device-Malaria-Product Status 50

Table 81: Rapid Test Device-Malaria-Product Description 50

Table 82: SenGenix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

Table 83: SenGenix Strips And Reader System-Product Status 51

Table 84: SenGenix Strips And Reader System-Product Description 51

Table 85: Thermal Gradient, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Table 86: FlashDirect-HC-Product Status 52

Table 87: FlashDirect-HC-Product Description 53

Table 88: FlashDirect-LC-Product Status 53

Table 89: FlashDirect-LC-Product Description 53

Table 90: University of Alberta Pipeline Products & Ongoing Clinical Trials Overview 54

Table 91: POC Device-Zika Virus-Product Status 54

Table 92: POC Device-Zika Virus-Product Description 54

Table 93: University of California, Berkeley Pipeline Products & Ongoing Clinical Trials Overview 55

Table 94: Microfluidic Blotting Device-Product Status 55

Table 95: Microfluidic Blotting Device-Product Description 55

Table 96: Multi-dimensional Microfluidic Device-Product Status 56

Table 97: Multi-dimensional Microfluidic Device-Product Description 56

Table 98: University of California, Davis Pipeline Products & Ongoing Clinical Trials Overview 57

Table 99: Blood Safety Microchip-Product Status 57

Table 100: Blood Safety Microchip-Product Description 57

Table 101: Wellstat Diagnostics, LLC Pipeline Products & Ongoing Clinical Trials Overview 58

Table 102: Electrochemiluminescent Based RNA Detection Platform-Product Status 58

Table 103: Electrochemiluminescent Based RNA Detection Platform-Product Description 58

Table 104: Xen Biofluidx Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Table 105: Xen System-Product Status 59

Table 106: Xen System-Product Description 59

Table 107: Glossary 62

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Akers Biosciences, Inc.

Akonni Biosystems, Inc.

ApoCell, Inc.

Attophotonics Biosciences GmbH

Bio-Alternative Medical Devices Ltd

BioDirection, Inc.

BioMedomics, Inc

bioMerieux S.A.

Biopico Systems Inc.

Boston University

Cepheid

Co-Diagnostics HBDC, Inc.

Indian Institute of Technology, Madras

John Hopkins University

Magna Diagnostics GmbH

McKesson Corporation

Nanomix, Inc.

OncoGenesis

Phoenix Biosystems Inc

PositiveID Corporation

Quanterix Corporation

Radisens Diagnostics Limited

Rapid Biosensor Systems

SenGenix, Inc.

Thermal Gradient, Inc.

University of Alberta

University of California, Berkeley

University of California, Davis

Wellstat Diagnostics, LLC

Xen Biofluidx Inc

Akers Biosciences, Inc., minDNAnalyzer; Akonni Biosystems, Inc., Point-Of-Care Device-Tuberculosis; ApoCell, Inc., ApoStream System; Attophotonics Biosciences GmbH, Nanoparticle Microfluidic Color Device; Bio-Alternative Medical Devices Ltd, Magnetic Immunoassay Detection System; BioDirection, Inc., Tbit Hand-held System; BioMedomics, Inc, Next Generation Ultra-sensitive Nanotube Platform; BioMedomics, Inc, TR-LFIA Diagnostic Platform; bioMerieux S.A., Magnotech System; Biopico Systems Inc., MONITOR System; Boston University, Molecular Diagnostic Device-Sexually Transmitted Infections; Cepheid, GeneXpert Omni; Cepheid, GeneXpert Omni CLIA-Waived Point-of-Care System; Co-Diagnostics HBDC, Inc., LightPCR; Indian Institute of Technology, Madras, Microfluidic Flow Analyzer; John Hopkins University, Point-Of-Care Sensor-Brain Injury; Magna Diagnostics GmbH, MAZER System; McKesson Corporation, Proventys PDx System; Nanomix, Inc., Nanomix System-Ebola Virus; OncoGenesis, Genesis Point-Of-Care Diagnostic System; Phoenix Biosystems Inc, Point of Care HIV Combo Device; PositiveID Corporation, Firefly Dx System-Zika Virus; Quanterix Corporation, POC Device-Neurological Injuries; Quanterix Corporation, Simoa 5.0; Radisens Diagnostics Limited, Radisens Instrument; Rapid Biosensor Systems, Rapid Test Device-Malaria; SenGenix, Inc., SenGenix Strips And Reader System; Thermal Gradient, Inc., FlashDirect-HC; Thermal Gradient, Inc., FlashDirect-LC; University of Alberta, POC Device-Zika Virus; University of California, Berkeley, Microfluidic Blotting Device; University of California, Berkeley, Multi-dimensional Microfluidic Device; University of California, Davis, Blood Safety Microchip; Wellstat Diagnostics, LLC, Electrochemiluminescent Based RNA Detection Platform; Xen Biofluidx Inc, Xen System

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