Parasitology & Mycology Rapid Tests & Point of Care (POC) - Medical Devices Pipeline Assessment, 2017

2017-09-01
Price :
Published : Sep-2017
No. of Pages : 90
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 8
2 Introduction 9
2.1 Parasitology & Mycology Rapid Tests & Point of Care (POC) Overview 9
3 Products under Development 10
3.1 Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 10
3.2 Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 11
3.3 Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 12
3.4 Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 13
4 Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products under Development by Companies 14
4.1 Parasitology & Mycology Rapid Tests & Point of Care (POC) Companies - Pipeline Products by Stage of Development 14
4.2 Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 16
5 Parasitology & Mycology Rapid Tests & Point of Care (POC) Companies and Product Overview 18
5.1 Abingdon Health Ltd Company Overview 18
5.1.1 Abingdon Health Ltd Pipeline Products & Ongoing Clinical Trials Overview 18
5.2 Access Bio Inc Company Overview 19
5.2.1 Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 19
5.3 AdvanDx Inc Company Overview 21
5.3.1 AdvanDx Inc Pipeline Products & Ongoing Clinical Trials Overview 21
5.4 Akers Biosciences Inc Company Overview 22
5.4.1 Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 22
5.5 Ampath Trust Company Overview 23
5.5.1 Ampath Trust Pipeline Products & Ongoing Clinical Trials Overview 23
5.6 Amplino B.V. Company Overview 24
5.6.1 Amplino B.V. Pipeline Products & Ongoing Clinical Trials Overview 24
5.7 Antigen Discovery Inc Company Overview 25
5.7.1 Antigen Discovery Inc Pipeline Products & Ongoing Clinical Trials Overview 25
5.8 Atlas Genetics Ltd Company Overview 26
5.8.1 Atlas Genetics Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
5.9 Atomo Diagnostics Pty Limited Company Overview 27
5.9.1 Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 27
5.10 BBB Technologies Inc Company Overview 28
5.10.1 BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 28
5.11 Bruker Daltonik GmbH Company Overview 29
5.11.1 Bruker Daltonik GmbH Pipeline Products & Ongoing Clinical Trials Overview 29
5.12 Ceres Nanosciences Inc Company Overview 30
5.12.1 Ceres Nanosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 30
5.13 Chembio Diagnostic Systems Inc Company Overview 31
5.13.1 Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 31
5.14 CrossLife Technologies Inc Company Overview 32
5.14.1 CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 32
5.15 DetectoGen Inc Company Overview 33
5.15.1 DetectoGen Inc Pipeline Products & Ongoing Clinical Trials Overview 33
5.16 DxDiscovery, Inc. Company Overview 34
5.16.1 DxDiscovery, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.17 DxNA LLC Company Overview 36
5.17.1 DxNA LLC Pipeline Products & Ongoing Clinical Trials Overview 36
5.18 Eiken Chemical Co Ltd Company Overview 37
5.18.1 Eiken Chemical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37
5.19 Fast-track diagnostics S.a.r.l. Company Overview 38
5.19.1 Fast-track diagnostics S.a.r.l. Pipeline Products & Ongoing Clinical Trials Overview 38
5.20 Foundation for Innovative New Diagnostics Company Overview 40
5.20.1 Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 40
5.21 genedrive plc Company Overview 42
5.21.1 genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 42
5.22 GenePOC Inc Company Overview 43
5.22.1 GenePOC Inc Pipeline Products & Ongoing Clinical Trials Overview 43
5.23 GlucoSentient Inc Company Overview 44
5.23.1 GlucoSentient Inc Pipeline Products & Ongoing Clinical Trials Overview 44
5.24 Group K Diagnostics Company Overview 45
5.24.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 45
5.25 Innova Biotechnology Co Ltd Company Overview 46
5.25.1 Innova Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 46
5.26 Institute for Development Research Company Overview 47
5.26.1 Institute for Development Research Pipeline Products & Ongoing Clinical Trials Overview 47
5.27 Institute of Molecular Biology of Parana Company Overview 49
5.27.1 Institute of Molecular Biology of Parana Pipeline Products & Ongoing Clinical Trials Overview 49
5.28 Labsystems Diagnostics Oy Company Overview 50
5.28.1 Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 50
5.29 Makerere University Company Overview 51
5.29.1 Makerere University Pipeline Products & Ongoing Clinical Trials Overview 51
5.30 mBio Diagnostics Inc Company Overview 52
5.30.1 mBio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 52
5.31 Meridian Bioscience Inc Company Overview 53
5.31.1 Meridian Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 53
5.32 Meru University of Science & Technology Company Overview 54
5.32.1 Meru University of Science & Technology Pipeline Products & Ongoing Clinical Trials Overview 54
5.33 Micronics Inc Company Overview 55
5.33.1 Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 55
5.34 Molbio Diagnostics Pvt. Ltd. Company Overview 57
5.34.1 Molbio Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57
5.35 MycoMed Technologies, LLC Company Overview 58
5.35.1 MycoMed Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 58
5.36 NG Biotech Company Overview 59
5.36.1 NG Biotech Pipeline Products & Ongoing Clinical Trials Overview 59
5.37 NOWDiagnostics Company Overview 61
5.37.1 NOWDiagnostics Pipeline Products & Ongoing Clinical Trials Overview 61
5.38 PATH medical GmbH Company Overview 63
5.38.1 PATH medical GmbH Pipeline Products & Ongoing Clinical Trials Overview 63
5.39 Protein Advances Inc Company Overview 64
5.39.1 Protein Advances Inc Pipeline Products & Ongoing Clinical Trials Overview 64
5.40 Singapore Immunology Network Company Overview 65
5.40.1 Singapore Immunology Network Pipeline Products & Ongoing Clinical Trials Overview 65
5.41 Stanford University Company Overview 66
5.41.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 66
5.42 Technical University of Munich Company Overview 67
5.42.1 Technical University of Munich Pipeline Products & Ongoing Clinical Trials Overview 67
5.43 University of Delhi Company Overview 68
5.43.1 University of Delhi Pipeline Products & Ongoing Clinical Trials Overview 68
5.44 University of Nevada Reno Company Overview 69
5.44.1 University of Nevada Reno Pipeline Products & Ongoing Clinical Trials Overview 69
5.45 Vanderbilt University Company Overview 72
5.45.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 72
5.46 Whidiag SAS Company Overview 73
5.46.1 Whidiag SAS Pipeline Products & Ongoing Clinical Trials Overview 73
6 Parasitology & Mycology Rapid Tests & Point of Care (POC)- Recent Developments 74
6.1 Jul 20, 2017: Trinity Biotech Announces Results for Q2, 2017 74
6.2 Jul 10, 2017: DxNA LLC Announces 510(K) Submission of the GeneSTAT Analyzer and GeneSTAT Coccidioides Assay 75
6.3 Jun 13, 2017: TECHLAB Receives FDA 510(k) Clearance To Market E. HISTOLYTICA QUIK CHEK To Aid Clinicians In The Diagnosis Of Amebiasis Caused By The E. Histolytica Parasite 76
6.4 May 16, 2017: NOWDiagnostics CEO Kevin Clark to Address Technology Conference 77
6.5 Apr 27, 2017: Trinity Biotech Announces Results for Q1, 2017 77
6.6 Apr 25, 2017: Alere Launches the Alere Malaria Ag P.f, the First-Ever Rapid Test to Screen Malaria Infection in Asymptomatic Individuals 78
6.7 Mar 29, 2017: Omega Diagnostics Announces VISITECT Malaria CE-Mark and successful Indian FDA inspection 80
6.8 Mar 29, 2017: Omega Diagnostics Group: VISITECT Malaria Pf/PAN CE-Mark and successful Indian FDA inspection 80
6.9 Mar 29, 2017: Omega Diagnostics Group Announces CE-Mark Approval for VISITECT Malaria Pf/Pv and successful Indian FDA inspection 80
6.10 Mar 14, 2017: Trinity Biotech announces Quarter 4 and Fiscal Year 2016 Financial Results 81
6.11 Nov 03, 2016: GenePOC Announces Setup of an Extensive Network of Commercial Partners Across Europe for Distribution 83
6.12 Oct 25, 2016: Trinity Biotech announces Quarter 3 Financial Results 84
6.13 Sep 06, 2016: Cepheid's Xpert TV Now Cleared For Testing Symptomatic And Asymptomatic Men 86
7 Appendix 87
7.1 Methodology 87
7.2 About GlobalData 90
7.3 Contact Us 90
7.4 Disclaimer 90

1.1 List of Tables
Table 1: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 10
Table 2: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 11
Table 3: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 12
Table 4: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 13
Table 5: Parasitology & Mycology Rapid Tests & Point of Care (POC) Companies - Pipeline Products by Stage of Development 14
Table 6: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 16
Table 7: Abingdon Health Ltd Pipeline Products & Ongoing Clinical Trials Overview 18
Table 8: Rapid Molecular Diagnostic Test - Malaria - Product Status 18
Table 9: Rapid Molecular Diagnostic Test - Malaria - Product Description 18
Table 10: Access Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 19
Table 11: ICT - Malaria RDT - Product Status 19
Table 12: ICT - Malaria RDT - Product Description 19
Table 13: Malaria Serology Test - Product Status 20
Table 14: Malaria Serology Test - Product Description 20
Table 15: AdvanDx Inc Pipeline Products & Ongoing Clinical Trials Overview 21
Table 16: Candida QuickFISH - Product Status 21
Table 17: Candida QuickFISH - Product Description 21
Table 18: Akers Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 22
Table 19: PIFA PLUSS Malaria Rapid Assay - Product Status 22
Table 20: PIFA PLUSS Malaria Rapid Assay - Product Description 22
Table 21: Ampath Trust Pipeline Products & Ongoing Clinical Trials Overview 23
Table 22: CAA UCP - LF Test Strip - Product Status 23
Table 23: CAA UCP - LF Test Strip - Product Description 23
Table 24: Amplino B.V. Pipeline Products & Ongoing Clinical Trials Overview 24
Table 25: Scout POC Assay - Product Status 24
Table 26: Scout POC Assay - Product Description 24
Table 27: Antigen Discovery Inc Pipeline Products & Ongoing Clinical Trials Overview 25
Table 28: Microfluidic Point of Care Device - Product Status 25
Table 29: Microfluidic Point of Care Device - Product Description 25
Table 30: Atlas Genetics Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
Table 31: Atlas io System - Trichomonas Vaginalis - Product Status 26
Table 32: Atlas io System - Trichomonas Vaginalis - Product Description 26
Table 33: Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 27
Table 34: AtomoRapid - Malaria - Product Status 27
Table 35: AtomoRapid - Malaria - Product Description 27
Table 36: BBB Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 28
Table 37: Mobile RDT Reader - Malaria Test - Product Status 28
Table 38: Mobile RDT Reader - Malaria Test - Product Description 28
Table 39: Bruker Daltonik GmbH Pipeline Products & Ongoing Clinical Trials Overview 29
Table 40: MALDI Biotyper - Fungal Infection - Product Status 29
Table 41: MALDI Biotyper - Fungal Infection - Product Description 29
Table 42: Ceres Nanosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 30
Table 43: Nanotrap Malaria Test - Product Status 30
Table 44: Nanotrap Malaria Test - Product Description 30
Table 45: Chembio Diagnostic Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 46: DPP Malaria - Product Status 31
Table 47: DPP Malaria - Product Description 31
Table 48: CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 32
Table 49: Point-Of-Care Diagnostic Assay - Dengue - Product Status 32
Table 50: Point-Of-Care Diagnostic Assay - Dengue - Product Description 32
Table 51: DetectoGen Inc Pipeline Products & Ongoing Clinical Trials Overview 33
Table 52: Antigen Detection Test - Kala Azar - Product Status 33
Table 53: Antigen Detection Test - Kala Azar - Product Description 33
Table 54: DxDiscovery, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 55: Diagnostic Assay - Candidiasis - Product Status 34
Table 56: Diagnostic Assay - Candidiasis - Product Description 34
Table 57: Diagnostic Assay - Crytococcosis - Product Status 35
Table 58: Diagnostic Assay - Crytococcosis - Product Description 35
Table 59: DxNA LLC Pipeline Products & Ongoing Clinical Trials Overview 36
Table 60: Valley Fever Test - Product Status 36
Table 61: Valley Fever Test - Product Description 36
Table 62: Eiken Chemical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37
Table 63: LAMP Test - Chagas Disease - Product Status 37
Table 64: LAMP Test - Chagas Disease - Product Description 37
Table 65: Fast-track diagnostics S.a.r.l. Pipeline Products & Ongoing Clinical Trials Overview 38
Table 66: FTD Dermatophytes Assay - Product Status 38
Table 67: FTD Dermatophytes Assay - Product Description 38
Table 68: FTD Stool Parasites Assay - Product Status 39
Table 69: FTD Stool Parasites Assay - Product Description 39
Table 70: Foundation for Innovative New Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 40
Table 71: Infection Detection Test - P. falciparum - Product Status 40
Table 72: Infection Detection Test - P. falciparum - Product Description 40
Table 73: P. vivax Serology Test - Product Status 41
Table 74: P. vivax Serology Test - Product Description 41
Table 75: genedrive plc Pipeline Products & Ongoing Clinical Trials Overview 42
Table 76: Genedrive - Malaria Assay - Product Status 42
Table 77: Genedrive - Malaria Assay - Product Description 42
Table 78: GenePOC Inc Pipeline Products & Ongoing Clinical Trials Overview 43
Table 79: revogene - Candida albicans Assay - Product Status 43
Table 80: revogene - Candida albicans Assay - Product Description 43
Table 81: GlucoSentient Inc Pipeline Products & Ongoing Clinical Trials Overview 44
Table 82: Point-Of-Care Screening Assay - Fungal Infections - Product Status 44
Table 83: Point-Of-Care Screening Assay - Fungal Infections - Product Description 44
Table 84: Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 45
Table 85: Multidiagnostic - Malaria Test - Product Status 45
Table 86: Multidiagnostic - Malaria Test - Product Description 45
Table 87: Innova Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 46
Table 88: Rapid Test - Malaria - Product Status 46
Table 89: Rapid Test - Malaria - Product Description 46
Table 90: Institute for Development Research Pipeline Products & Ongoing Clinical Trials Overview 47
Table 91: Diagnostic Test - Amebiasis - Product Status 47
Table 92: Diagnostic Test - Amebiasis - Product Description 47
Table 93: Rapid Diagnostic Test - American Tegumentary Leishmaniasis - Product Status 48
Table 94: Rapid Diagnostic Test - American Tegumentary Leishmaniasis - Product Description 48
Table 95: Institute of Molecular Biology of Parana Pipeline Products & Ongoing Clinical Trials Overview 49
Table 96: Point-of-Care Diagnostic Test - Chagas Disease - Product Status 49
Table 97: Point-of-Care Diagnostic Test - Chagas Disease - Product Description 49
Table 98: Labsystems Diagnostics Oy Pipeline Products & Ongoing Clinical Trials Overview 50
Table 99: Biocard Malaria Test - Product Status 50
Table 100: Biocard Malaria Test - Product Description 50
Table 101: Makerere University Pipeline Products & Ongoing Clinical Trials Overview 51
Table 102: Diagnostic Test - African Trypanosomiasis - Product Status 51
Table 103: Diagnostic Test - African Trypanosomiasis - Product Description 51
Table 104: mBio Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 52
Table 105: POC Diagnostic Device - Malaria - Product Status 52
Table 106: POC Diagnostic Device - Malaria - Product Description 52
Table 107: Meridian Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 108: Illumigene Babesia Assay - Product Status 53
Table 109: Illumigene Babesia Assay - Product Description 53
Table 110: Meru University of Science & Technology Pipeline Products & Ongoing Clinical Trials Overview 54
Table 111: Rapid Diagnostic Test - African Trypanosomiasis - Product Status 54
Table 112: Rapid Diagnostic Test - African Trypanosomiasis - Product Description 54
Table 113: Micronics Inc Pipeline Products & Ongoing Clinical Trials Overview 55
Table 114: PanNAT - Malaria Assay - Product Status 55
Table 115: PanNAT - Malaria Assay - Product Description 55
Table 116: PanNAT - TV Assay - Product Status 56
Table 117: PanNAT - TV Assay - Product Description 56
Table 118: Molbio Diagnostics Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57
Table 119: Truenat Trichomonas Assay - Product Status 57
Table 120: Truenat Trichomonas Assay - Product Description 57
Table 121: MycoMed Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 58
Table 122: AspUTest - Product Status 58
Table 123: AspUTest - Product Description 58
Table 124: NG Biotech Pipeline Products & Ongoing Clinical Trials Overview 59
Table 125: NG-Quant Pf/Malaria Test - Product Status 59
Table 126: NG-Quant Pf/Malaria Test - Product Description 59
Table 127: NG-Telediag pf/Pan Test - Product Status 60
Table 128: NG-Telediag pf/Pan Test - Product Description 60
Table 129: NOWDiagnostics Pipeline Products & Ongoing Clinical Trials Overview 61
Table 130: ADEXUSDx Test - Malaria - Product Status 61
Table 131: ADEXUSDx Test - Malaria - Product Description 61
Table 132: ADEXUSDx Trichomoniasis Test - Product Status 62
Table 133: ADEXUSDx Trichomoniasis Test - Product Description 62
Table 134: PATH medical GmbH Pipeline Products & Ongoing Clinical Trials Overview 63
Table 135: PATH Chagas Immunochromatographic Strip Test - Product Status 63
Table 136: PATH Chagas Immunochromatographic Strip Test - Product Description 63
Table 137: Protein Advances Inc Pipeline Products & Ongoing Clinical Trials Overview 64
Table 138: Diagnostic Test - Human African Trypanosomiasis - Product Status 64
Table 139: Diagnostic Test - Human African Trypanosomiasis - Product Description 64
Table 140: Singapore Immunology Network Pipeline Products & Ongoing Clinical Trials Overview 65
Table 141: Rapid Diagnostic Assay - Malaria - Product Status 65
Table 142: Rapid Diagnostic Assay - Malaria - Product Description 65
Table 143: Stanford University Pipeline Products & Ongoing Clinical Trials Overview 66
Table 144: Rapid Antibody Test - Soil-Transmitted Helminths - Product Status 66
Table 145: Rapid Antibody Test - Soil-Transmitted Helminths - Product Description 66
Table 146: Technical University of Munich Pipeline Products & Ongoing Clinical Trials Overview 67
Table 147: Malaria Blood Test - Product Status 67
Table 148: Malaria Blood Test - Product Description 67
Table 149: University of Delhi Pipeline Products & Ongoing Clinical Trials Overview 68
Table 150: Rapid Diagnostic Kit - Trichomonas Vaginalis - Product Status 68
Table 151: Rapid Diagnostic Kit - Trichomonas Vaginalis - Product Description 68
Table 152: University of Nevada Reno Pipeline Products & Ongoing Clinical Trials Overview 69
Table 153: Diagnostic Assay - Aspergillosis - Product Status 69
Table 154: Diagnostic Assay - Aspergillosis - Product Description 69
Table 155: Diagnostic Assay - Fungal Disease - Product Status 70
Table 156: Diagnostic Assay - Fungal Disease - Product Description 70
Table 157: Diagnostic Assay - Tinea Capitis - Product Status 70
Table 158: Diagnostic Assay - Tinea Capitis - Product Description 71
Table 159: Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 72
Table 160: Point-of-Care Biomarker Test - Malaria - Product Status 72
Table 161: Point-of-Care Biomarker Test - Malaria - Product Description 72
Table 162: Whidiag SAS Pipeline Products & Ongoing Clinical Trials Overview 73
Table 163: Rapid Diagnostic Test - Leishmaniasis - Product Status 73
Table 164: Rapid Diagnostic Test - Leishmaniasis - Product Description 73
Table 165: Glossary 89

1.2 List of Figures
Figure 1: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Stage of Development 10
Figure 2: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Territory 11
Figure 3: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Regulatory Path 12
Figure 4: Parasitology & Mycology Rapid Tests & Point of Care (POC) - Pipeline Products by Estimated Approval Date 13
Filed in: Medical Device
Publisher : GlobalData