Published : Dec-2019
No. of Pages : 318
Table of Contents
1.1 List of Tables 8
1.2 List of Figures 12
2 Introduction 13
2.1 Retrovirus Tests Overview 13
Retrovirus Tests are the diagnostic tests used to detect the antigen/antibody of HIV1, HIV 2 (human immunodeficiency virus) and HTLV I, HTLV II (human T-cell lymphotropic virus) viruses. 13
3 Products under Development 14
3.1 Retrovirus Tests - Pipeline Products by Stage of Development 14
3.2 Retrovirus Tests - Pipeline Products by Segment 15
3.3 Retrovirus Tests - Pipeline Products by Territory 16
3.4 Retrovirus Tests - Pipeline Products by Regulatory Path 17
3.5 Retrovirus Tests - Pipeline Products by Estimated Approval Date 18
4 Retrovirus Tests - Pipeline Products under Development by Companies 19
4.1 Retrovirus Tests Companies - Pipeline Products by Stage of Development 19
4.2 Retrovirus Tests - Pipeline Products by Stage of Development 22
5 Retrovirus Tests Companies and Product Overview 25
5.1 Accelevir Diagnostics LLC Company Overview 25
5.2 Advanced Liquid Logic Inc Company Overview 26
5.3 Alere Inc Company Overview 27
5.4 Allied Innovative Systems, LLC Company Overview 29
5.5 Autoimmune Technologies LLC Company Overview 30
5.6 Avioq, Inc. Company Overview 31
5.7 Ayanda Biosystems SA (Inactive) Company Overview 32
5.8 Biokit SA Company Overview 33
5.9 Biomagnetics Diagnostics Corp Company Overview 35
5.10 Calypte Biomedical Corporation Company Overview 37
5.11 CeMines, Inc. (Inactive) Company Overview 38
5.12 Cepheid Company Overview 39
5.13 ChipCare Corp Company Overview 40
5.14 Co-Diagnostics Inc Company Overview 41
5.15 Conrad Company Overview 42
5.16 Cue Inc. Company Overview 44
5.17 Diagnostics for the Real World (Europe) Ltd Company Overview 45
5.18 DiaSorin SpA Company Overview 47
5.19 DNAE Group Holdings Ltd Company Overview 48
5.20 Enable Biosciences Inc Company Overview 49
5.21 Enzo Biochem Inc Company Overview 50
5.22 ERBA Molecular Ltd Company Overview 51
5.23 Eurobio Scientific SA Company Overview 53
5.24 Fast Track Diagnostics Ltd. Company Overview 55
5.25 Fujirebio Diagnostics Inc Company Overview 56
5.26 Genome Diagnostics Pvt. Ltd. Company Overview 59
5.27 Immunetics Inc Company Overview 61
5.28 Institute for Development Research Company Overview 62
5.29 IRIS International Inc Company Overview 63
5.30 Jan Biotech Inc Company Overview 64
5.31 Johns Hopkins University Company Overview 65
5.32 MedMira Inc Company Overview 66
5.33 MedNostic Technologies, LLC Company Overview 67
5.34 MND Diagnostic LTD Company Overview 68
5.35 Molecular Testing Labs Company Overview 69
5.36 Monogram Biosciences Inc Company Overview 70
5.37 Odyssey Thera, inc. (Inactive) Company Overview 71
5.38 Oregon Health & Science University Company Overview 72
5.39 Ortho-Clinical Diagnostics Inc Company Overview 73
5.40 Paramedical Srl Company Overview 76
5.41 Pathogenica Inc Company Overview 77
5.42 PATHseq Diagnostics Inc Company Overview 78
5.43 PixCell Medical Technologies Ltd Company Overview 79
5.44 Purdue University Company Overview 80
5.45 Rice University Company Overview 81
5.46 Roche Diagnostics International Ltd Company Overview 82
5.47 Sansure Biotech Inc Company Overview 87
5.48 Seattle Children's Hospital Company Overview 88
5.49 Seegene Inc Company Overview 89
5.50 Shenzhen New Industries Biomedical Engineering Co Ltd Company Overview 90
5.51 Siemens Healthcare Diagnostics Inc Company Overview 91
5.52 Siemens Healthineers AG Company Overview 92
5.53 Syamala Srinivasa Life Sciences Pvt. Ltd Company Overview 93
5.54 TheraDiag SA Company Overview 94
5.55 TrovaGene Inc Company Overview 96
5.56 University of California San Diego Company Overview 97
5.57 University of Washington Company Overview 98
5.58 Ustar Biotechnologies (Hangzhou) Ltd. Company Overview 99
5.59 VEGA Ltd Company Overview 100
6 Retrovirus Tests- Recent Developments 101
6.1 Nov 07, 2019: Trovagene announces third quarter 2019 results and highlights 101
6.2 Nov 06, 2019: USFDA authorises marketing of Sentosa SQ HIV Genotyping Assay 103
6.3 Nov 06, 2019: LabCorp announces Departure of John Ratliff, names New LabCorp Diagnostics leadershin 104
6.4 Nov 06, 2019: OraSure announces 2019 third quarter financial results 104
6.5 Nov 06, 2019: Hologic announces financial results for fourth quarter of fiscal 2019 106
6.6 Nov 05, 2019: FDA drants De Novo designation to Vela Diagnostics next generation sequencing HIV-1 genotyping assay 108
6.7 Nov 05, 2019: BD announces results for 2019 fourth fiscal quarter and full year; provides fiscal 2020 guidance 108
6.8 Nov 05, 2019: OPKO Health reports 2019 third quarter business highlights and financial results 110
6.9 Nov 04, 2019: Quotient reports second quarter fiscal 2020 financial results 111
6.10 Oct 31, 2019: Bio-Rad reports third-quarter 2019 financial results 113
7 Appendix 314
7.1 Methodology 314
7.2 About GlobalData 317
7.3 Contact Us 317
7.4 Disclaimer 317
List of Tables
Table 1: Retrovirus Tests - Pipeline Products by Stage of Development 17
Table 2: Retrovirus Tests - Pipeline Products by Segment 18
Table 3: Retrovirus Tests - Pipeline Products by Territory 19
Table 4: Retrovirus Tests - Pipeline Products by Regulatory Path 20
Table 5: Retrovirus Tests - Pipeline Products by Estimated Approval Date 21
Table 6: Retrovirus Tests Companies - Pipeline Products by Stage of Development 22
Table 7: Retrovirus Tests - Pipeline Products by Stage of Development 25
Table 8: Accelevir Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 29
Table 9: Diagnostic Test - Latent HIV-1 Virus - Product Status 29
Table 10: Diagnostic Test - Latent HIV-1 Virus - Product Description 29
Table 11: Advanced Liquid Logic Inc Pipeline Products & Ongoing Clinical Trials Overview 30
Table 12: Portable Benchtop Analyzer - Viral Load Assay - Product Status 30
Table 13: Portable Benchtop Analyzer - Viral Load Assay - Product Description 30
Table 14: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 15: AIMS System - HIV-1 Test - Product Status 31
Table 16: AIMS System - HIV-1 Test - Product Description 31
Table 17: Alere HIV Self-Test - Product Status 32
Table 18: Alere HIV Self-Test - Product Description 32
Table 19: AtheNA Multi-Lyte System - HIV-1 Test - Product Status 32
Table 20: AtheNA Multi-Lyte System - HIV-1 Test - Product Description 32
Table 21: Allied Innovative Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 33
Table 22: HIV p24 Antigen ELISA - Product Status 33
Table 23: HIV p24 Antigen ELISA - Product Description 33
Table 24: Autoimmune Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 34
Table 25: Viral Protein Antibody Test - Non-HIV AIDS - Product Status 34
Table 26: Viral Protein Antibody Test - Non-HIV AIDS - Product Description 34
Table 27: Avioq, Inc. Pipeline Products & Ongoing Clinical Trials Overview 36
Table 28: VioOne HIV Profile Supplemental Assay - Product Status 36
Table 29: VioOne HIV Profile Supplemental Assay - Product Description 36
Table 30: Ayanda Biosystems SA (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 37
Table 31: DETECTHIV - Product Status 37
Table 32: DETECTHIV - Product Description 37
Table 33: Biokit SA Pipeline Products & Ongoing Clinical Trials Overview 38
Table 34: BIO-FLASH HIV-1+2 Ag/Ab Assay - Product Status 38
Table 35: BIO-FLASH HIV-1+2 Ag/Ab Assay - Product Description 38
Table 36: HTLV Ab Assay - Product Status 39
Table 37: HTLV Ab Assay - Product Description 39
Table 38: Biomagnetics Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 40
Table 39: Diagnostic Test - HIV - Product Status 40
Table 40: Diagnostic Test - HIV - Product Description 40
Table 41: IOBS - HIV Diagnostic Test - Product Status 42
Table 42: IOBS - HIV Diagnostic Test - Product Description 42
Table 43: Calypte Biomedical Corporation Pipeline Products & Ongoing Clinical Trials Overview 43
Table 44: Second Generation Incidence Test - HIV - Product Status 43
Table 45: Second Generation Incidence Test - HIV - Product Description 43
Table 46: CeMines, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 44
Table 47: Diagnostic Test - HIV - Product Status 44
Table 48: Diagnostic Test - HIV - Product Description 44
Table 49: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 45
Table 50: Xpert HIV Quant Assay - Product Status 45
Table 51: Xpert HIV Quant Assay - Product Description 45
Table 52: ChipCare Corp Pipeline Products & Ongoing Clinical Trials Overview 46
Table 53: CD4 Assay - HIV - Product Status 46
Table 54: CD4 Assay - HIV - Product Description 46
Table 55: Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 47
Table 56: HIV RNA Real-time PCR Kit - Product Status 47
Table 57: HIV RNA Real-time PCR Kit - Product Description 47
Table 58: Conrad Pipeline Products & Ongoing Clinical Trials Overview 48
Table 59: Biomarker - HIV Acquisition - Product Status 48
Table 60: Biomarker - HIV Acquisition - Product Description 48
List of Figures
Figure 1: Retrovirus Tests - Pipeline Products by Stage of Development 15
Figure 2: Retrovirus Tests - Pipeline Products by Segment 16
Figure 3: Retrovirus Tests - Pipeline Products by Territory 17
Figure 4: Retrovirus Tests - Pipeline Products by Regulatory Path 18
Figure 5: Retrovirus Tests - Pipeline Products by Estimated Approval Date 19
