Point-of-Care (POC) Analyzers - Medical Devices Pipeline Assessment, 2019

Table of Contents

• 1.1 List of Tables 7
• 1.2 List of Figures 11

2 Introduction 12

• 2.1 Point-of-Care (POC) Analyzers Overview 12

3 Products under Development 13

• 3.1 Point-of-Care (POC) Analyzers - Pipeline Products by Stage of Development 13
• 3.2 Point-of-Care (POC) Analyzers - Pipeline Products by Territory 14
• 3.3 Point-of-Care (POC) Analyzers - Pipeline Products by Regulatory Path 15
• 3.4 Point-of-Care (POC) Analyzers - Pipeline Products by Estimated Approval Date 16
• 3.5 Point-of-Care (POC) Analyzers - Ongoing Clinical Trials 17

4 Point-of-Care (POC) Analyzers - Pipeline Products under Development by Companies 18

• 4.1 Point-of-Care (POC) Analyzers Companies - Pipeline Products by Stage of Development 18
• 4.2 Point-of-Care (POC) Analyzers - Pipeline Products by Stage of Development 21

5 Point-of-Care (POC) Analyzers Companies and Product Overview 24

• 5.1 Access Bio Inc Company Overview 24
  • 5.1.1 Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 24
• 5.2 Acrongenomics Inc (Inactive) Company Overview 25
  • 5.2.1 Acrongenomics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 25
• 5.3 AgPlus Diagnostics LTD Company Overview 26
  • 5.3.1 AgPlus Diagnostics LTD Pipeline Products & Ongoing Clinical Trials Overview 26
• 5.4 Akers Biosciences Inc Company Overview 27
  • 5.4.1 Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 27
• 5.5 Akonni Biosystems Inc Company Overview 29
  • 5.5.1 Akonni Biosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 29
• 5.6 Alere Inc Company Overview 30
  • 5.6.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 30
• 5.7 Analytical Diagnostic Solutions Inc Company Overview 31
  • 5.7.1 Analytical Diagnostic Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 31
• 5.8 ApoCell Inc Company Overview 33
  • 5.8.1 ApoCell Inc Pipeline Products & Ongoing Clinical Trials Overview 33
• 5.9 Aptatek BioSciences Inc Company Overview 34
  • 5.9.1 Aptatek BioSciences Inc Pipeline Products & Ongoing Clinical Trials Overview 34
• 5.10 Atonomics A/S Company Overview 35
  • 5.10.1 Atonomics A/S Pipeline Products & Ongoing Clinical Trials Overview 35
• 5.11 BBB Technologies Inc Company Overview 36
  • 5.11.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 36
• 5.12 Binghampton University Company Overview 37
  • 5.12.1 Binghampton University Pipeline Products & Ongoing Clinical Trials Overview 37
• 5.13 Bio-AMD Inc Company Overview 38
  • 5.13.1 Bio-AMD Inc Pipeline Products & Ongoing Clinical Trials Overview 38
• 5.14 BioMedomics Inc Company Overview 39
  • 5.14.1 BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 39
• 5.15 Biopico Systems Inc Company Overview 40
  • 5.15.1 Biopico Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 40
• 5.16 Biosensia Ltd Company Overview 41
  • 5.16.1 Biosensia Ltd Pipeline Products & Ongoing Clinical Trials Overview 41
• 5.17 Boston University Company Overview 42
  • 5.17.1 Boston University Pipeline Products & Ongoing Clinical Trials Overview 42
• 5.18 BreviTest Technologies LLC Company Overview 43
  • 5.18.1 BreviTest Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 43
• 5.19 Brigham and Women's Hospital Company Overview 44
  • 5.19.1 Brigham and Women's Hospital Pipeline Products & Ongoing Clinical Trials Overview 44
• 5.20 Calmark Sweden AB Company Overview 45
  • 5.20.1 Calmark Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 45
• 5.21 Canon USA Inc Company Overview 47
  • 5.21.1 Canon USA Inc Pipeline Products & Ongoing Clinical Trials Overview 47
• 5.22 CardioGenics Inc Company Overview 48
  • 5.22.1 CardioGenics Inc Pipeline Products & Ongoing Clinical Trials Overview 48
• 5.23 Center for Innovation in Point-of-Care Technologies for HIV/AIDS Company Overview 49
  • 5.23.1 Center for Innovation in Point-of-Care Technologies for HIV/AIDS Pipeline Products & Ongoing Clinical Trials Overview 49
• 5.24 Cepheid Company Overview 51
  • 5.24.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 51
• 5.25 ChipCare Corp Company Overview 54
  • 5.25.1 ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 54
• 5.26 City, University of London Company Overview 55
  • 5.26.1 City, University of London Pipeline Products & Ongoing Clinical Trials Overview 55
• 5.27 Co-Diagnostics Inc Company Overview 56
  • 5.27.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 56
• 5.28 Cornell University Company Overview 57
  • 5.28.1 Cornell University Pipeline Products & Ongoing Clinical Trials Overview 57
• 5.29 Cutting Edge Medical Devices Limited Company Overview 58
  • 5.29.1 Cutting Edge Medical Devices Limited Pipeline Products & Ongoing Clinical Trials Overview 58
• 5.30 Diagnostics For All Inc Company Overview 59
  • 5.30.1 Diagnostics For All Inc Pipeline Products & Ongoing Clinical Trials Overview 59
• 5.31 Duke University Company Overview 60
  • 5.31.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 60
• 5.32 EKF Diagnostics Holdings Plc Company Overview 61
  • 5.32.1 EKF Diagnostics Holdings Plc Pipeline Products & Ongoing Clinical Trials Overview 61
• 5.33 Endeavor Sciences Inc Company Overview 62
  • 5.33.1 Endeavor Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 62
• 5.34 ExcitePCR Corp Company Overview 63
  • 5.34.1 ExcitePCR Corp Pipeline Products & Ongoing Clinical Trials Overview 63
• 5.35 Exosome Diagnostics Inc Company Overview 64
  • 5.35.1 Exosome Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 64
• 5.36 Fawkes Biotechnology LLC Company Overview 65
  • 5.36.1 Fawkes Biotechnology LLC Pipeline Products & Ongoing Clinical Trials Overview 65
• 5.37 First Light Diagnostics Inc Company Overview 66
  • 5.37.1 First Light Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 66
• 5.38 Florida International University Company Overview 67
  • 5.38.1 Florida International University Pipeline Products & Ongoing Clinical Trials Overview 67
• 5.39 Future Diagnostics Solutions BV Company Overview 68
  • 5.39.1 Future Diagnostics Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 68
• 5.40 Giner Inc Company Overview 69
  • 5.40.1 Giner Inc Pipeline Products & Ongoing Clinical Trials Overview 69
• 5.41 GlucoSentient Inc Company Overview 70
  • 5.41.1 GlucoSentient Inc Pipeline Products & Ongoing Clinical Trials Overview 70
• 5.42 Indian Institute of Science Company Overview 71
  • 5.42.1 Indian Institute of Science Pipeline Products & Ongoing Clinical Trials Overview 71
• 5.43 Indian Institute of Technology Chennai Company Overview 72
  • 5.43.1 Indian Institute of Technology Chennai Pipeline Products & Ongoing Clinical Trials Overview 72
• 5.44 Lucendi Inc Company Overview 73
  • 5.44.1 Lucendi Inc Pipeline Products & Ongoing Clinical Trials Overview 73
• 5.45 Masaryk University Company Overview 74
  • 5.45.1 Masaryk University Pipeline Products & Ongoing Clinical Trials Overview 74
• 5.46 Maxygen-mobile DNA tests Company Overview 75
  • 5.46.1 Maxygen-mobile DNA tests Pipeline Products & Ongoing Clinical Trials Overview 75
• 5.47 mBio Diagnostics Inc Company Overview 76
  • 5.47.1 mBio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 76
• 5.48 McKesson Corp Company Overview 78
  • 5.48.1 McKesson Corp Pipeline Products & Ongoing Clinical Trials Overview 78
• 5.49 Meridian Bioscience Inc Company Overview 79
  • 5.49.1 Meridian Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 79
• 5.50 MML Ltd Company Overview 80
  • 5.50.1 MML Ltd Pipeline Products & Ongoing Clinical Trials Overview 80
• 5.51 Molecular Warehouse Ltd Company Overview 81
  • 5.51.1 Molecular Warehouse Ltd Pipeline Products & Ongoing Clinical Trials Overview 81
• 5.52 Nalia Systems Ltd Company Overview 82
  • 5.52.1 Nalia Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 82
• 5.53 Newcastle University Company Overview 83
  • 5.53.1 Newcastle University Pipeline Products & Ongoing Clinical Trials Overview 83
• 5.54 Nikkiso Co Ltd Company Overview 85
  • 5.54.1 Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 85
• 5.55 Ohmx Corp Company Overview 86
  • 5.55.1 Ohmx Corp Pipeline Products & Ongoing Clinical Trials Overview 86
• 5.56 OncoGenesis Company Overview 87
  • 5.56.1 OncoGenesis Pipeline Products & Ongoing Clinical Trials Overview 87
• 5.57 Ontera Inc Company Overview 88
  • 5.57.1 Ontera Inc Pipeline Products & Ongoing Clinical Trials Overview 88
• 5.58 Pacific Nanoscience, Inc. Company Overview 89
  • 5.58.1 Pacific Nanoscience, Inc. Pipeline Products & Ongoing Clinical Trials Overview 89
• 5.59 POC Medical Systems Inc Company Overview 90
  • 5.59.1 POC Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 90
• 5.60 ProciseDx LLC Company Overview 91
  • 5.60.1 ProciseDx LLC Pipeline Products & Ongoing Clinical Trials Overview 91
• 5.61 Quanterix Corp Company Overview 92
  • 5.61.1 Quanterix Corp Pipeline Products & Ongoing Clinical Trials Overview 92
• 5.62 Qvella Corp Company Overview 93
  • 5.62.1 Qvella Corp Pipeline Products & Ongoing Clinical Trials Overview 93
• 5.63 Radisens Diagnostics Ltd Company Overview 94
  • 5.63.1 Radisens Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 94
• 5.64 Raman Diagnostics Ltd (Inactive) Company Overview 95
  • 5.64.1 Raman Diagnostics Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 95
• 5.65 RMIT University Company Overview 96
  • 5.65.1 RMIT University Pipeline Products & Ongoing Clinical Trials Overview 96
• 5.66 SeLux Diagnostics Inc Company Overview 97
  • 5.66.1 SeLux Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 97
• 5.67 SenGenix Inc Company Overview 99
  • 5.67.1 SenGenix Inc Pipeline Products & Ongoing Clinical Trials Overview 99
• 5.68 StemTek Therapeutics SL Company Overview 100
  • 5.68.1 StemTek Therapeutics SL Pipeline Products & Ongoing Clinical Trials Overview 100
• 5.69 Thermal Gradient Inc Company Overview 101
  • 5.69.1 Thermal Gradient Inc Pipeline Products & Ongoing Clinical Trials Overview 101
• 5.70 Trinity Biotech Plc Company Overview 103
  • 5.70.1 Trinity Biotech Plc Pipeline Products & Ongoing Clinical Trials Overview 103
• 5.71 University of Calgary Company Overview 105
  • 5.71.1 University of Calgary Pipeline Products & Ongoing Clinical Trials Overview 105
• 5.72 University of California Berkeley Company Overview 106
  • 5.72.1 University of California Berkeley Pipeline Products & Ongoing Clinical Trials Overview 106
• 5.73 University of Glasgow Company Overview 109
  • 5.73.1 University of Glasgow Pipeline Products & Ongoing Clinical Trials Overview 109
• 5.74 University of Illinois at Chicago Company Overview 110
  • 5.74.1 University of Illinois at Chicago Pipeline Products & Ongoing Clinical Trials Overview 110
• 5.75 Wellstat Diagnostics LLC Company Overview 111
  • 5.75.1 Wellstat Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 111

6 Point-of-Care (POC) Analyzers- Recent Developments 112

• 6.1 Oct 30, 2019: First Light Diagnostics joins global initiative to combat antibiotic resistance 112
• 6.2 Oct 30, 2019: McKesson reports fiscal 2020 second-quarter results 112
• 6.3 Oct 23, 2019: bioMerieux – Third-Quarter 2019 Business Review 114
• 6.4 Oct 22, 2019: bioMerieux – Third quarter 2019 business review 115
• 6.5 Oct 18, 2019: Calmark extends the time plan for CE-mark of the biomarkers LDH and Glucose - market launch as according to plan 117
• 6.6 Oct 18, 2019: McKesson’s Board of Directors appoints Maria Martinez as new independent Director 117
• 6.7 Oct 16, 2019: BioDirection announces move of corporate headquarters to Southborough, Massachusetts 118
• 6.8 Oct 08, 2019: Results for Calmark's initial biomarker, bilirubin, are within the expected range - project enters verification and validation phase to obtain CE mark 119
• 6.9 Oct 02, 2019: Selux Diagnostics beats key contract milestone, receives $11.4m in additional funding 119
• 6.10 Sep 25, 2019: Dr. Joanne Spadoro Joins First Light Diagnostics 120

7 Appendix 152

• 7.1 Methodology 152
• 7.2 About GlobalData 155
• 7.3 Contact Us 155