Cervical Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2019

Published : Nov-2019

No. of Pages : 113

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Table of Contents
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 Cervical Cancer Diagnostic Tests Overview 7
3 Products under Development 8
3.1 Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 8
3.2 Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 9
3.3 Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 10
3.4 Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 11
3.5 Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 12
4 Cervical Cancer Diagnostic Tests - Pipeline Products under Development by Companies 13
4.1 Cervical Cancer Diagnostic Tests Companies - Pipeline Products by Stage of Development 13
4.2 Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 14
5 Cervical Cancer Diagnostic Tests Companies and Product Overview 15
5.1 Alere Inc Company Overview 15
5.1.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 15
5.2 Augusta University Company Overview 16
5.2.1 Augusta University Pipeline Products & Ongoing Clinical Trials Overview 16
5.3 Becton Dickinson and Co Company Overview 17
5.3.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 17
5.4 Bio Techne Corp Company Overview 21
5.4.1 Bio Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 BioAffinity Technologies, Inc. Company Overview 22
5.5.1 BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 22
5.6 BioMark Diagnostics Inc Company Overview 23
5.6.1 BioMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 23
5.7 BioMark Technologies Inc Company Overview 24
5.7.1 BioMark Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 24
5.8 Cepheid Company Overview 25
5.8.1 Cepheid Pipeline Products & Ongoing Clinical Trials Overview 25
5.9 China Sky One Medical Inc Company Overview 26
5.9.1 China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 26
5.10 Cytosystems Ltd Company Overview 27
5.10.1 Cytosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
5.11 Enzo Biochem Inc Company Overview 28
5.11.1 Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 28
5.12 Exact Sciences Corp Company Overview 29
5.12.1 Exact Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 29
5.13 GenomicTree Inc Company Overview 30
5.13.1 GenomicTree Inc Pipeline Products & Ongoing Clinical Trials Overview 30
5.14 GRANT Life Sciences, Inc. Company Overview 32
5.14.1 GRANT Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
5.15 HLL Lifecare Ltd Company Overview 33
5.15.1 HLL Lifecare Ltd Pipeline Products & Ongoing Clinical Trials Overview 33
5.16 Louisville Bioscience, Inc. Company Overview 34
5.16.1 Louisville Bioscience, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.17 MDNA Life Sciences Inc Company Overview 35
5.17.1 MDNA Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 35
5.18 MDxHealth SA Company Overview 36
5.18.1 MDxHealth SA Pipeline Products & Ongoing Clinical Trials Overview 36
5.19 Milagen Inc Company Overview 37
5.19.1 Milagen Inc Pipeline Products & Ongoing Clinical Trials Overview 37
5.20 Olympia Diagnostics Inc Company Overview 38
5.20.1 Olympia Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 38
5.21 Oncgnostics GmbH Company Overview 40
5.21.1 Oncgnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 40
5.22 ONCOVEDA Cancer Research Center Company Overview 41
5.22.1 ONCOVEDA Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 41
5.23 Precision Biologics Inc Company Overview 42
5.23.1 Precision Biologics Inc Pipeline Products & Ongoing Clinical Trials Overview 42
5.24 US Biomarkers Inc Company Overview 43
5.24.1 US Biomarkers Inc Pipeline Products & Ongoing Clinical Trials Overview 43
5.25 XEPTAGEN SpA Company Overview 44
5.25.1 XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 44
6 Cervical Cancer Diagnostic Tests - Recent Developments 45
6.1 Nov 05, 2019: BD announces results for 2019 fourth fiscal quarter and full year; provides fiscal 2020 guidance 45
6.2 Oct 30, 2019: Genomic Vision: Financial information for the third quarter of 2019 46
6.3 Oct 23, 2019: AdvaMed Statement on BD Sterilization Plant in Georgia 47
6.4 Oct 22, 2019: Quest Diagnostics reports third quarter 2019 financial results 48
6.5 Oct 03, 2019: Genomic Vision and PolyAn sign an agreement for the production and supply of Coverslips 48
6.6 Sep 26, 2019: BD announces leadership succession plan 49
6.7 Sep 24, 2019: Genomic Vision: First-half 2019 results 50
6.8 Sep 10, 2019: Quest Diagnostics names Manuel O. Méndez as new commercial leader 53
6.9 Aug 29, 2019: MDxHealth reports half year 2019 financial results and strategic update 54
6.10 Aug 26, 2019: New technique isolates placental cells for non-invasive genetic testing 56
6.11 Aug 20, 2019: Cancer Genetics reports second quarter 2019 financial results and provides strategic business update 57
6.12 Aug 06, 2019: BD announces results for 2019 third fiscal quarter; reaffirms fiscal 2019 guidance 58
7 Appendix 110
7.1 Methodology 110
7.2 About GlobalData 113
7.3 Contact Us 113
7.4 Disclaimer 113

List of Tables
Table 1: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 10
Table 2: Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 11
Table 3: Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 12
Table 4: Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 13
Table 5: Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 14
Table 6: Cervical Cancer Diagnostic Tests Companies - Pipeline Products by Stage of Development 15
Table 7: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 16
Table 8: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 17
Table 9: NMP179 Test - Product Status 17
Table 10: NMP179 Test - Product Description 17
Table 11: Augusta University Pipeline Products & Ongoing Clinical Trials Overview 18
Table 12: Folate Receptor Biomarker Test - Cervical Cancer Diagnostic Tests - Product Status 18
Table 13: Folate Receptor Biomarker Test - Cervical Cancer Diagnostic Tests - Product Description 18
Table 14: Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 19
Table 15: BD SurePath Plus Molecular Pap Test System - Product Status 19
Table 16: BD SurePath Plus Molecular Pap Test System - Product Description 19
Table 17: Biomarker Test - Cervical Cancer Diagnostic Tests - Product Status 20
Table 18: Biomarker Test - Cervical Cancer Diagnostic Tests - Product Description 20
Table 19: Becton Dickinson and Co - Ongoing Clinical Trials Overview 21
Table 20: BD SurePath Plus Molecular Pap Test System - Validation of High Resolution Microendoscope in the Screening of Cervical Cancer Precursor Lesions in Brazil: UH3 - Brazil 22
Table 21: Bio Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 23
Table 22: RNAscope HPV Assay - Cervical Cancer Diagnostic Tests - Product Status 23
Table 23: RNAscope HPV Assay - Cervical Cancer Diagnostic Tests - Product Description 23
Table 24: BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25
Table 25: CyPath Diagnostic Assay - Cervical Cancer Diagnostic Tests - Product Status 25
Table 26: CyPath Diagnostic Assay - Cervical Cancer Diagnostic Tests - Product Description 25
Table 27: BioMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 26
Table 28: Metabolomics-based Diagnostic Assay - Cervical Cancer Diagnostic Tests - Product Status 26
Table 29: Metabolomics-based Diagnostic Assay - Cervical Cancer Diagnostic Tests - Product Description 26
Table 30: BioMark Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 28
Table 31: Biomarker Assay - Cervical Cancer Diagnostic Tests - Product Status 28
Table 32: Biomarker Assay - Cervical Cancer Diagnostic Tests - Product Description 28
Table 33: Cepheid Pipeline Products & Ongoing Clinical Trials Overview 29
Table 34: Xpert Molecular PAP Assay - Product Status 29
Table 35: Xpert Molecular PAP Assay - Product Description 29
Table 36: China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 30
Table 37: Diagnostic Kit - Carcinoma Cervix - Product Status 30
Table 38: Diagnostic Kit - Carcinoma Cervix - Product Description 30
Table 39: Cytosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 31
Table 40: Laboratory-Based Diagnostic Test - Cervical Cancer Diagnostic Tests - Product Status 31
Table 41: Laboratory-Based Diagnostic Test - Cervical Cancer Diagnostic Tests - Product Description 31
Table 42: Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 32
Table 43: p16 Biomarker - Cervical Cancer Diagnostic Tests - Product Status 32
Table 44: p16 Biomarker - Cervical Cancer Diagnostic Tests - Product Description 32
Table 45: Exact Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 33
Table 46: Liquid Biopsy Test - Cervical Cancer Diagnostic Tests - Product Status 33
Table 47: Liquid Biopsy Test - Cervical Cancer Diagnostic Tests - Product Description 33
Table 48: GenomicTree Inc Pipeline Products & Ongoing Clinical Trials Overview 35
Table 49: EarlyTect Cervical Cancer Diagnostic Tests - Product Status 35
Table 50: EarlyTect Cervical Cancer Diagnostic Tests - Product Description 35
Table 51: Screening Test - Cervical Cancer Diagnostic Tests - Product Status 36
Table 52: Screening Test - Cervical Cancer Diagnostic Tests - Product Description 36
Table 53: GRANT Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37
Table 54: Serum-Based Test - Cervical Cancer Diagnostic Tests - Product Status 37
Table 55: Serum-Based Test - Cervical Cancer Diagnostic Tests - Product Description 37
Table 56: HLL Lifecare Ltd Pipeline Products & Ongoing Clinical Trials Overview 38
Table 57: Diagnostic ELISA - Cervical Cancer Diagnostic Tests - Product Status 38
Table 58: Diagnostic ELISA - Cervical Cancer Diagnostic Tests - Product Description 38
Table 59: Louisville Bioscience, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39
Table 60: Cervical Cancer Remission pT Test - Product Status 39

List of Figures
Figure 1: Cervical Cancer Diagnostic Tests - Pipeline Products by Stage of Development 8
Figure 2: Cervical Cancer Diagnostic Tests - Pipeline Products by Territory 9
Figure 3: Cervical Cancer Diagnostic Tests - Pipeline Products by Regulatory Path 10
Figure 4: Cervical Cancer Diagnostic Tests - Pipeline Products by Estimated Approval Date 11
Figure 5: Cervical Cancer Diagnostic Tests - Ongoing Clinical Trials 12

Filed in: Pharmaceutical, Pharmaceuticals and Healthcare

Publisher : GlobalData

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