Liver Cancer Diagnostic Tests – Medical Devices Pipeline Assessment, 2020

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 7

2 Introduction 8

2.1 Liver Cancer Overview 8

3 Products under Development 9

3.1 Liver Cancer – Pipeline Products by Stage of Development 9

3.2 Liver Cancer – Pipeline Products by Territory 10

3.3 Liver Cancer – Pipeline Products by Regulatory Path 11

3.4 Liver Cancer – Pipeline Products by Estimated Approval Date 12

3.5 Liver Cancer – Ongoing Clinical Trials 13

4 Liver Cancer – Pipeline Products under Development by Companies 14

4.1 Liver Cancer Companies – Pipeline Products by Stage of Development 14

4.2 Liver Cancer – Pipeline Products by Stage of Development 16

5 Liver Cancer Companies and Product Overview 18

5.1 Abbott Diagnostics Company Overview 18

5.1.1 Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Abcodia Ltd Company Overview 23

5.2.1 Abcodia Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

5.3 AXO Science SAS Company Overview 24

5.3.1 AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 24

5.4 BioMark Technologies Inc Company Overview 27

5.4.1 BioMark Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 27

5.5 Bioprognos SL Company Overview 28

5.5.1 Bioprognos SL Pipeline Products & Ongoing Clinical Trials Overview 28

5.6 China Sky One Medical Inc Company Overview 29

5.6.1 China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29

5.7 Digna Biotech SL Company Overview 30

5.7.1 Digna Biotech SL Pipeline Products & Ongoing Clinical Trials Overview 30

5.8 Exact Sciences Corp Company Overview 32

5.8.1 Exact Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 32

5.9 German Cancer Research Center Company Overview 34

5.9.1 German Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 34

5.10 Glycotest Inc Company Overview 35

5.10.1 Glycotest Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.11 Glympse Bio Inc Company Overview 38

5.11.1 Glympse Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.12 ImCare Biotech LLC Company Overview 39

5.12.1 ImCare Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 39

5.13 Imperial College London Company Overview 40

5.13.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 40

5.14 IntegraGen SA Company Overview 41

5.14.1 IntegraGen SA Pipeline Products & Ongoing Clinical Trials Overview 41

5.15 IPDx Immunoprofiling Diagnostics GmbH Company Overview 42

5.15.1 IPDx Immunoprofiling Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 42

5.16 JBS Science Inc Company Overview 43

5.16.1 JBS Science Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.17 Matrix-Bio Inc Company Overview 44

5.17.1 Matrix-Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.18 MDNA Life Sciences Inc Company Overview 46

5.18.1 MDNA Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.19 Medical University of South Carolina Company Overview 47

5.19.1 Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 47

5.20 Medical University of Vienna Company Overview 48

5.20.1 Medical University of Vienna Pipeline Products & Ongoing Clinical Trials Overview 48

5.21 Memorial Sloan Kettering Cancer Center Company Overview 49

5.21.1 Memorial Sloan Kettering Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 49

5.22 NanoString Technologies Inc Company Overview 50

5.22.1 NanoString Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.23 Northwestern University Company Overview 51

5.23.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 51

5.24 Numares AG Company Overview 52

5.24.1 Numares AG Pipeline Products & Ongoing Clinical Trials Overview 52

5.25 Oncimmune (USA) LLC Company Overview 53

5.25.1 Oncimmune (USA) LLC Pipeline Products & Ongoing Clinical Trials Overview 53

5.26 Orion Genomics LLC Company Overview 54

5.26.1 Orion Genomics LLC Pipeline Products & Ongoing Clinical Trials Overview 54

5.27 PleX Diagnostics Inc (Inactive) Company Overview 55

5.27.1 PleX Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 55

5.28 ProMIS Neurosciences Inc Company Overview 56

5.28.1 ProMIS Neurosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.29 Proplex Technologies Llc Company Overview 57

5.29.1 Proplex Technologies Llc Pipeline Products & Ongoing Clinical Trials Overview 57

5.30 Proteome Sciences Plc Company Overview 58

5.30.1 Proteome Sciences Plc Pipeline Products & Ongoing Clinical Trials Overview 58

5.31 Roche Diagnostics International Ltd Company Overview 59

5.31.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

5.32 University of Hong Kong Company Overview 60

5.32.1 University of Hong Kong Pipeline Products & Ongoing Clinical Trials Overview 60

5.33 University of Louisville Company Overview 62

5.33.1 University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 62

5.34 University of Rochester Company Overview 63

5.34.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 63

5.35 Ventana Medical Systems Inc Company Overview 64

5.35.1 Ventana Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.36 Viomics Inc. Company Overview 65

5.36.1 Viomics Inc. Pipeline Products & Ongoing Clinical Trials Overview 65

5.37 XEPTAGEN SpA Company Overview 66

5.37.1 XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 66

5.38 Ymir Genomics LLC. Company Overview 70

5.38.1 Ymir Genomics LLC. Pipeline Products & Ongoing Clinical Trials Overview 70

6 Liver Cancer- Recent Developments 71

6.1 Sep 30, 2020: Skoltech scientists discovered a new biomarker for liver cancer diagnosis 71

6.2 Jul 30, 2020: Blueprint Medicines reports second quarter 2020 financial results 71

6.3 Jun 24, 2020: Novel radiotracer proves advantageous for imaging neuroendocrine tumor patients with liver-dominant disease 74

6.4 Jun 15, 2020: Study demonstrates feasibility of hologram technology in liver tumor ablation 74

6.5 Jun 02, 2020: Pfizer establishes new program to support continued biotechnology innovation 75

6.6 May 12, 2020: National Cancer Institute renews Jackson Laboratory’s Cancer Center Designation 76

6.7 Feb 27, 2020: James Quincey elected to Pfizer’s board of directors 77

6.8 Feb 14, 2020: Pfizer: Appointment of Mr. Samir Kazi as an executive director 77

6.9 Feb 14, 2020: Pfizer: Resignation of Mr. Vivek Dhariwal 78

6.10 Feb 13, 2020: Blueprint Medicines reports fourth quarter and full year 2019 financial results 78

6.11 Jan 28, 2020: Pfizer reports fourth-quarter and full-year 2019 results 80

6.12 Jan 27, 2020: PerkinElmer announces financial results for the fourth quarter 87

6.13 Jan 13, 2020: Blueprint Medicines announces 2020 corporate goals 89

6.14 Jan 02, 2020: Pfizer, Sanofi and GlaxoSmithKline plan to increase US drug prices in 2020 90

6.15 Dec 18, 2019: Pfizer and Mylan announce two future Viatris board members 90

6.16 Dec 16, 2019: Pfizer declares first-quarter 2020 dividend and announces upcoming investor day to highlight strength of innovative R&D pipeline 91

7 Appendix 92

7.1 Methodology 92

7.2 About GlobalData 96

7.3 Contact Us 96

Table 1: Liver Cancer – Pipeline Products by Stage of Development 9

Table 2: Liver Cancer – Pipeline Products by Territory 10

Table 3: Liver Cancer – Pipeline Products by Regulatory Path 11

Table 4: Liver Cancer – Pipeline Products by Estimated Approval Date 12

Table 5: Liver Cancer – Ongoing Clinical Trials 13

Table 6: Liver Cancer Companies – Pipeline Products by Stage of Development 14

Table 7: Liver Cancer – Pipeline Products by Stage of Development 16

Table 8: Abbott Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 18

Table 9: ARCHITECT c16000 System – PIVKA Assay – Product Status 18

Table 10: ARCHITECT c16000 System – PIVKA Assay – Product Description 19

Table 11: ARCHITECT c4000 System – PIVKA Assay – Product Status 19

Table 12: ARCHITECT c4000 System – PIVKA Assay – Product Description 19

Table 13: ARCHITECT c8000 System – PIVKA Assay – Product Status 20

Table 14: ARCHITECT c8000 System – PIVKA Assay – Product Description 20

Table 15: ARCHITECT ci16200 Integrated System – PIVKA Assay – Product Status 20

Table 16: ARCHITECT ci16200 Integrated System – PIVKA Assay – Product Description 20

Table 17: ARCHITECT ci4100 Integrated System – PIVKA Assay – Product Status 21

Table 18: ARCHITECT ci4100 Integrated System – PIVKA Assay – Product Description 21

Table 19: ARCHITECT ci8200 Integrated System – PIVKA Assay – Product Status 21

Table 20: ARCHITECT ci8200 Integrated System – PIVKA Assay – Product Description 22

Table 21: ARCHITECT i4000SR System – PIVKA II Assay – Product Status 22

Table 22: ARCHITECT i4000SR System – PIVKA II Assay – Product Description 22

Table 23: Abcodia Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Table 24: Biomarker Test – Liver Cancer – Product Status 23

Table 25: Biomarker Test – Liver Cancer – Product Description 23

Table 26: AXO Science SAS Pipeline Products & Ongoing Clinical Trials Overview 24

Table 27: Multiplexed Detection – Des-Carboxy Prothrombin – Product Status 24

Table 28: Multiplexed Detection – Des-Carboxy Prothrombin – Product Description 24

Table 29: Multiplexed Detection – Matrix metalloproteinase 1 – Product Status 25

Table 30: Multiplexed Detection – Matrix metalloproteinase 1 – Product Description 25

Table 31: Multiplexed Detection – Procollagen type III N-terminal peptide – Product Status 25

Table 32: Multiplexed Detection – Procollagen type III N-terminal peptide – Product Description 26

Table 33: BioMark Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 27

Table 34: Biomarker Assay – Hepatocellular Cancer – Product Status 27

Table 35: Biomarker Assay – Hepatocellular Cancer – Product Description 27

Table 36: Bioprognos SL Pipeline Products & Ongoing Clinical Trials Overview 28

Table 37: MBDAA Liver Cancer Test – Product Status 28

Table 38: MBDAA Liver Cancer Test – Product Description 28

Table 39: China Sky One Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29

Table 40: Diagnostic Kit – Liver Cancer – Product Status 29

Table 41: Diagnostic Kit – Liver Cancer – Product Description 29

Table 42: Digna Biotech SL Pipeline Products & Ongoing Clinical Trials Overview 30

Table 43: HCC Molecular Marker Assay – Product Status 30

Table 44: HCC Molecular Marker Assay – Product Description 30

Table 45: Oxidated APO-A1 Assay – Product Status 31

Table 46: Oxidated APO-A1 Assay – Product Description 31

Table 47: Exact Sciences Corp Pipeline Products & Ongoing Clinical Trials Overview 32

Table 48: DNA Biomarkers – Hepatocellular Carcinoma – Product Status 32

Table 49: DNA Biomarkers – Hepatocellular Carcinoma – Product Description 32

Table 50: Liquid Biopsy Test – Liver Cancer – Product Status 33

Table 51: Liquid Biopsy Test – Liver Cancer – Product Description 33

Table 52: German Cancer Research Center Pipeline Products & Ongoing Clinical Trials Overview 34

Table 53: RAGE Based Diagnostic Assay – Liver Cancer – Product Status 34

Table 54: RAGE Based Diagnostic Assay – Liver Cancer – Product Description 34

Table 55: Glycotest Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Table 56: HCC Panel – Product Status 35

Table 57: HCC Panel – Product Description 35

Table 58: Glycotest Inc – Ongoing Clinical Trials Overview 36

Table 59: HCC Panel – Case-control Study of the Glycotest HCC Panel Versus AFP for the Detection of Early-stage Hepatocellular Carcinoma 37

Table 60: Glympse Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 61: Ultrasensitive Diagnostic Test – HCC – Product Status 38

Table 62: Ultrasensitive Diagnostic Test – HCC – Product Description 38

Table 63: ImCare Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 39

Table 64: Seravue Diagnostic Kit – Product Status 39

Table 65: Seravue Diagnostic Kit – Product Description 39

Table 66: Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 40

Table 67: Diagnostic Assay – HCC – Product Status 40

Table 68: Diagnostic Assay – HCC – Product Description 40

Table 69: IntegraGen SA Pipeline Products & Ongoing Clinical Trials Overview 41

Table 70: Diagnostic Test – Hepatocellular Carcinoma – Product Status 41

Table 71: Diagnostic Test – Hepatocellular Carcinoma – Product Description 41

Table 72: IPDx Immunoprofiling Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 42

Table 73: Diagnostic Test – Liver Cancer – Product Status 42

Table 74: Diagnostic Test – Liver Cancer – Product Description 42

Table 75: JBS Science Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 76: JBS HCC Urine DNA Screening Test – Product Status 43

Table 77: JBS HCC Urine DNA Screening Test – Product Description 43

Table 78: Matrix-Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 79: VeraMarker LCS (Liver Cancer Screening) Test – Product Status 44

Table 80: VeraMarker LCS (Liver Cancer Screening) Test – Product Description 44

Table 81: VeraMarker Liver Cancer Screening Test – Hepatitis – Product Status 45

Table 82: VeraMarker Liver Cancer Screening Test – Hepatitis – Product Description 45

Table 83: MDNA Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Table 84: Mitomic Liver Test – Product Status 46

Table 85: Mitomic Liver Test – Product Description 46

Table 86: Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 47

Table 87: Glycan-Based Biomarker Assay – Liver Cancer – Product Status 47

Table 88: Glycan-Based Biomarker Assay – Liver Cancer – Product Description 47

Table 89: Medical University of Vienna Pipeline Products & Ongoing Clinical Trials Overview 48

Table 90: sAXL Biomarker Test – Hepatocellular Carcinoma – Product Status 48

Table 91: sAXL Biomarker Test – Hepatocellular Carcinoma – Product Description 48

Table 92: Memorial Sloan Kettering Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 49

Table 93: Biomarker Test – Hepatocellular Carcinoma – Product Status 49

Table 94: Biomarker Test – Hepatocellular Carcinoma – Product Description 49

Table 95: NanoString Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 50

Table 96: In Vitro Diagnostic Assay – HCC Gene Signature – Product Status 50

Table 97: In Vitro Diagnostic Assay – HCC Gene Signature – Product Description 50

Table 98: Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 51

Table 99: Blood Test – Liver Cancer – Product Status 51

Table 100: Blood Test – Liver Cancer – Product Description 51

Table 101: Numares AG Pipeline Products & Ongoing Clinical Trials Overview 52

Table 102: Diagnostic Test – Liver Cancer – Product Status 52

Table 103: Diagnostic Test – Liver Cancer – Product Description 52

Table 104: Oncimmune (USA) LLC Pipeline Products & Ongoing Clinical Trials Overview 53

Table 105: EarlyCDT – Liver Cancer Kit – Product Status 53

Table 106: EarlyCDT – Liver Cancer Kit – Product Description 53

Table 107: Orion Genomics LLC Pipeline Products & Ongoing Clinical Trials Overview 54

Table 108: Diagnostic Assay – Liver Cancer – Product Status 54

Table 109: Diagnostic Assay – Liver Cancer – Product Description 54

Table 110: PleX Diagnostics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 55

Table 111: HCCpleX – Product Status 55

Table 112: HCCpleX – Product Description 55

Table 113: ProMIS Neurosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 114: Screening Test – Liver Cancer – Product Status 56

Table 115: Screening Test – Liver Cancer – Product Description 56

Table 116: Proplex Technologies Llc Pipeline Products & Ongoing Clinical Trials Overview 57

Table 117: Biomarker Diagnostic Test – Liver Cancer – Product Status 57

Table 118: Biomarker Diagnostic Test – Liver Cancer – Product Description 57

Table 119: Proteome Sciences Plc Pipeline Products & Ongoing Clinical Trials Overview 58

Table 120: Biomarker Assay – Liver Cancer – Product Status 58

Table 121: Biomarker Assay – Liver Cancer – Product Description 58

Table 122: Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

Table 123: Cobas 8000 Analyzer Series With e 801 Module – PIVKA Assay – Product Status 59

Table 124: Cobas 8000 Analyzer Series With e 801 Module – PIVKA Assay – Product Description 59

Table 125: University of Hong Kong Pipeline Products & Ongoing Clinical Trials Overview 60

Table 126: Annexin Biomarker Test – Hepatocellular Carcinoma – Product Status 60

Table 127: Annexin Biomarker Test – Hepatocellular Carcinoma – Product Description 60

Table 128: Granulin-Epithelin Precursor Test – Hepatocellular Carcinoma – Product Status 61

Table 129: Granulin-Epithelin Precursor Test – Hepatocellular Carcinoma – Product Description 61

Table 130: University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 62

Table 131: Diagnostic Test – Hepatocellular Carcinoma – Product Status 62

Table 132: Diagnostic Test – Hepatocellular Carcinoma – Product Description 62

Table 133: University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 63

Table 134: Biomarker Test – HCC – Product Status 63

Table 135: Biomarker Test – HCC – Product Description 63

Table 136: Ventana Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 64

Table 137: BLU-554 Companion Diagnostic Assay – Hepatocellular Carcinoma – Product Status 64

Table 138: BLU-554 Companion Diagnostic Assay – Hepatocellular Carcinoma – Product Description 64

Table 139: Viomics Inc. Pipeline Products & Ongoing Clinical Trials Overview 65

Table 140: Diagnostic Assay – Liver Cancer – Product Status 65

Table 141: Diagnostic Assay – Liver Cancer – Product Description 65

Table 142: XEPTAGEN SpA Pipeline Products & Ongoing Clinical Trials Overview 66

Table 143: DCP-IgM Kit – Liver Cancer – Product Status 66

Table 144: DCP-IgM Kit – Liver Cancer – Product Description 66

Table 145: GPC3-IgM Kit – Liver Cancer – Product Status 67

Table 146: GPC3-IgM Kit – Liver Cancer – Product Description 67

Table 147: Osteopontin-IgM Kit – Liver Cancer – Product Status 67

Table 148: Osteopontin-IgM Kit – Liver Cancer – Product Description 68

Table 149: Survivin-IgM Kit – Liver Cancer – Product Status 68

Table 150: Survivin-IgM Kit – Liver Cancer – Product Description 68

Table 151: VEGF-IgM Kit – Liver Cancer – Product Status 69

Table 152: VEGF-IgM Kit – Liver Cancer – Product Description 69

Table 153: Ymir Genomics LLC. Pipeline Products & Ongoing Clinical Trials Overview 70

Table 154: Diagnostic Assay – Hepatocellular Carcinoma – Product Status 70

Table 155: Diagnostic Assay – Hepatocellular Carcinoma – Product Description 70

Table 156: Glossary 95

Figure 1: Liver Cancer – Pipeline Products by Stage of Development 9

Figure 2: Liver Cancer – Pipeline Products by Territory 10

Figure 3: Liver Cancer – Pipeline Products by Regulatory Path 11

Figure 4: Liver Cancer – Pipeline Products by Estimated Approval Date 12

Figure 5: Liver Cancer – Ongoing Clinical Trials 13