Cervical Cancer Diagnostic Tests – Medical Devices Pipeline Assessment, 2020

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 5

2 Introduction 6

2.1 Cervical Cancer Overview 6

3 Products under Development 7

3.1 Cervical Cancer – Pipeline Products by Stage of Development 7

3.2 Cervical Cancer – Pipeline Products by Territory 8

3.3 Cervical Cancer – Pipeline Products by Regulatory Path 9

3.4 Cervical Cancer – Pipeline Products by Estimated Approval Date 10

4 Cervical Cancer – Pipeline Products under Development by Companies 11

4.1 Cervical Cancer Companies – Pipeline Products by Stage of Development 11

4.2 Cervical Cancer – Pipeline Products by Stage of Development 12

5 Cervical Cancer Companies and Product Overview 13

5.1 Alere Inc Company Overview 13

5.1.1 Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 13

5.2 Augusta University Company Overview 14

5.2.1 Augusta University Pipeline Products & Ongoing Clinical Trials Overview 14

5.3 Becton Dickinson and Co Company Overview 15

5.3.1 Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 15

5.4 Bio Techne Corp Company Overview 16

5.4.1 Bio Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 16

5.5 BioAffinity Technologies, Inc. Company Overview 17

5.5.1 BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 17

5.6 BioMark Diagnostics Inc Company Overview 18

5.6.1 BioMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 18

5.7 BioMark Technologies Inc Company Overview 20

5.7.1 BioMark Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.8 Cepheid Inc Company Overview 21

5.8.1 Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.9 China Sky One Medical Inc Company Overview 22

5.9.1 China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.10 Cytosystems Ltd Company Overview 23

5.10.1 Cytosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

5.11 Enzo Biochem Inc Company Overview 24

5.11.1 Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 24

5.12 Exact Sciences Corp Company Overview 25

5.12.1 Exact Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 25

5.13 GenomicTree Co Ltd Company Overview 26

5.13.1 GenomicTree Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

5.14 GRANT Life Sciences, Inc. Company Overview 28

5.14.1 GRANT Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 28

5.15 HLL Lifecare Ltd Company Overview 29

5.15.1 HLL Lifecare Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

5.16 Louisville Bioscience Inc (Inactive) Company Overview 30

5.16.1 Louisville Bioscience Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 30

5.17 MDNA Life Sciences Inc Company Overview 31

5.17.1 MDNA Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.18 MDxHealth SA Company Overview 32

5.18.1 MDxHealth SA Pipeline Products & Ongoing Clinical Trials Overview 32

5.19 Milagen Inc Company Overview 33

5.19.1 Milagen Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.20 Olympia Diagnostics Inc Company Overview 34

5.20.1 Olympia Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.21 ONCOVEDA Cancer Research Center Company Overview 36

5.21.1 ONCOVEDA Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 36

5.22 Precision Biologics Inc Company Overview 37

5.22.1 Precision Biologics Inc Pipeline Products & Ongoing Clinical Trials Overview 37

5.23 Roche Diagnostics International Ltd Company Overview 38

5.23.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 38

5.24 US Biomarkers Inc Company Overview 39

5.24.1 US Biomarkers Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.25 XEPTAGEN SpA Company Overview 40

5.25.1 XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 40

6 Cervical Cancer- Recent Developments 41

6.1 Oct 26, 2020: Cervical cancer study compares Dalrada Health VIA screening kits to pap smear, peer reviewed journal – The Gynecologist – publishes findings 41

6.2 Jul 31, 2020: New Cervical Cancer Screening Guidelines from the American Cancer Society risk reversing decades of progress made against Cervical Cancer 41

6.3 Jun 24, 2020: Cancer Genetics reports first quarter 2020 financial results and provides strategic business updates 43

6.4 Mar 12, 2020: Roche gets FDA approval for cytology test to prevent cervical cancer 44

6.5 Feb 26, 2020: MDxHealth reports financial year 2019 results and provides outlook for 2020 45

6.6 Feb 06, 2020: BD announces results for 2020 first fiscal quarter; lowers fiscal 2020 guidance 47

6.7 Jan 30, 2020: Quest Diagnostics reports record fourth quarter and full year 2019 revenues and earnings; provides guidance for full year 2020; increases dividend

5.7% to $0.56 per quarter 48

6.8 Jan 30, 2020: Genomic Vision: Financial information for the fourth quarter of 2019 49

6.9 Nov 20, 2019: Cancer Genetics reports third quarter 2019 financial results and provides strategic business update 50

6.10 Nov 12, 2019: Cancer Research UK appoints new Executive Director of Fundraising and Marketing 51

7 Appendix 52

7.1 Methodology 52

7.2 About GlobalData 56

7.3 Contact Us 56

Table 1: Cervical Cancer – Pipeline Products by Stage of Development 7

Table 2: Cervical Cancer – Pipeline Products by Territory 8

Table 3: Cervical Cancer – Pipeline Products by Regulatory Path 9

Table 4: Cervical Cancer – Pipeline Products by Estimated Approval Date 10

Table 5: Cervical Cancer Companies – Pipeline Products by Stage of Development 11

Table 6: Cervical Cancer – Pipeline Products by Stage of Development 12

Table 7: Alere Inc Pipeline Products & Ongoing Clinical Trials Overview 13

Table 8: NMP179 Test – Product Status 13

Table 9: NMP179 Test – Product Description 13

Table 10: Augusta University Pipeline Products & Ongoing Clinical Trials Overview 14

Table 11: Folate Receptor Biomarker Test – Cervical Cancer – Product Status 14

Table 12: Folate Receptor Biomarker Test – Cervical Cancer – Product Description 14

Table 13: Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 15

Table 14: BD SurePath Plus Molecular Pap Test System – Product Status 15

Table 15: BD SurePath Plus Molecular Pap Test System – Product Description 15

Table 16: Bio Techne Corp Pipeline Products & Ongoing Clinical Trials Overview 16

Table 17: RNAscope HPV Assay – Cervical Cancer – Product Status 16

Table 18: RNAscope HPV Assay – Cervical Cancer – Product Description 16

Table 19: BioAffinity Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 17

Table 20: CyPath Diagnostic Assay – Cervical Cancer – Product Status 17

Table 21: CyPath Diagnostic Assay – Cervical Cancer – Product Description 17

Table 22: BioMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 23: Metabolomics-based Diagnostic Assay – Cervical Cancer – Product Status 18

Table 24: Metabolomics-based Diagnostic Assay – Cervical Cancer – Product Description 19

Table 25: BioMark Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Table 26: Biomarker Assay – Cervical Cancer – Product Status 20

Table 27: Biomarker Assay – Cervical Cancer – Product Description 20

Table 28: Cepheid Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 29: Xpert Molecular PAP Assay – Product Status 21

Table 30: Xpert Molecular PAP Assay – Product Description 21

Table 31: China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Table 32: Diagnostic Kit – Carcinoma Cervix – Product Status 22

Table 33: Diagnostic Kit – Carcinoma Cervix – Product Description 22

Table 34: Cytosystems Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Table 35: Laboratory-Based Diagnostic Test – Cervical Cancer – Product Status 23

Table 36: Laboratory-Based Diagnostic Test – Cervical Cancer – Product Description 23

Table 37: Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Table 38: p16 Biomarker – Cervical cancer – Product Status 24

Table 39: p16 Biomarker – Cervical cancer – Product Description 24

Table 40: Exact Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 25

Table 41: Liquid Biopsy Test – Cervical Cancer – Product Status 25

Table 42: Liquid Biopsy Test – Cervical Cancer – Product Description 25

Table 43: GenomicTree Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

Table 44: EarlyTect Cervical Cancer – Product Status 26

Table 45: EarlyTect Cervical Cancer – Product Description 26

Table 46: Screening Test – Cervical Cancer – Product Status 27

Table 47: Screening Test – Cervical Cancer – Product Description 27

Table 48: GRANT Life Sciences, Inc. Pipeline Products & Ongoing Clinical Trials Overview 28

Table 49: Serum-Based Test – Cervical Cancer – Product Status 28

Table 50: Serum-Based Test – Cervical Cancer – Product Description 28

Table 51: HLL Lifecare Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

Table 52: Diagnostic ELISA – Cervical cancer – Product Status 29

Table 53: Diagnostic ELISA – Cervical cancer – Product Description 29

Table 54: Louisville Bioscience Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 30

Table 55: Cervical Cancer Remission pT Test – Product Status 30

Table 56: Cervical Cancer Remission pT Test – Product Description 30

Table 57: MDNA Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Table 58: Cervical Mitomic Test – Product Status 31

Table 59: Cervical Mitomic Test – Product Description 31

Table 60: MDxHealth SA Pipeline Products & Ongoing Clinical Trials Overview 32

Table 61: ClinicalMDx – Cervical Cancer – Product Status 32

Table 62: ClinicalMDx – Cervical Cancer – Product Description 32

Table 63: Milagen Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Table 64: Immunoassay – Cervical Cancer – Product Status 33

Table 65: Immunoassay – Cervical Cancer – Product Description 33

Table 66: Olympia Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 67: Diagnostic Test – Cervical Cancer – Product Status 34

Table 68: Diagnostic Test – Cervical Cancer – Product Description 34

Table 69: Prognostic Test – Cervical Cancer – Product Status 35

Table 70: Prognostic Test – Cervical Cancer – Product Description 35

Table 71: ONCOVEDA Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 36

Table 72: HPV Companion Diagnostic Test – Cervical Cancer – Product Status 36

Table 73: HPV Companion Diagnostic Test – Cervical Cancer – Product Description 36

Table 74: Precision Biologics Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 75: Diagnostic Assay – Cervical Cancer – Product Status 37

Table 76: Diagnostic Assay – Cervical Cancer – Product Description 37

Table 77: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 38

Table 78: CINtec Plus Cytology Kit – Product Status 38

Table 79: CINtec Plus Cytology Kit – Product Description 38

Table 80: US Biomarkers Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 81: Blood-Based Biomarker – Cervical Cancer – Product Status 39

Table 82: Blood-Based Biomarker – Cervical Cancer – Product Description 39

Table 83: XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 40

Table 84: SCCA – IgM Kit – Cervical Cancer – Product Status 40

Table 85: SCCA – IgM Kit – Cervical Cancer – Product Description 40

Table 86: Glossary 55

Figure 1: Cervical Cancer – Pipeline Products by Stage of Development 7

Figure 2: Cervical Cancer – Pipeline Products by Territory 8

Figure 3: Cervical Cancer – Pipeline Products by Regulatory Path 9

Figure 4: Cervical Cancer – Pipeline Products by Estimated Approval Date 10