Drugs of Abuse / Toxicology Rapid Tests - Medical Devices Pipeline Assessment, 2018

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 5

2 Introduction 6

2.1 Drugs of Abuse / Toxicology Rapid Tests Overview 6

3 Products under Development 7

3.1 Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Stage of Development 7

3.2 Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Territory 8

3.3 Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Regulatory Path 9

3.4 Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Estimated Approval Date 10

4 Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products under Development by Companies 11

4.1 Drugs of Abuse / Toxicology Rapid Tests Companies-Pipeline Products by Stage of Development 11

4.2 Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Stage of Development 12

5 Drugs of Abuse / Toxicology Rapid Tests Companies and Product Overview 13

5.1 American Bio Medica Corp Company Overview 13

5.1.1 American Bio Medica Corp Pipeline Products & Ongoing Clinical Trials Overview 13

5.2 Behavioral Diagnostics Inc Company Overview 17

5.2.1 Behavioral Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 17

5.3 Bio-Alternative Medical Devices Ltd Company Overview 18

5.3.1 Bio-Alternative Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 18

5.4 BioMedomics Inc Company Overview 19

5.4.1 BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 19

5.5 Biosensia Ltd Company Overview 21

5.5.1 Biosensia Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

5.6 Dimerix Ltd Company Overview 22

5.6.1 Dimerix Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

5.7 Group K Diagnostics Company Overview 23

5.7.1 Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 23

5.8 ImmunoScience Inc Company Overview 26

5.8.1 ImmunoScience Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.9 Quidel Corp Company Overview 27

5.9.1 Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 27

5.10 Rapid Pathogen Screening Inc Company Overview 29

5.10.1 Rapid Pathogen Screening Inc Pipeline Products & Ongoing Clinical Trials Overview 29

5.11 Seacoast Science, Inc. Company Overview 30

5.11.1 Seacoast Science, Inc. Pipeline Products & Ongoing Clinical Trials Overview 30

5.12 The University of South Australia Company Overview 31

5.12.1 The University of South Australia Pipeline Products & Ongoing Clinical Trials Overview 31

5.13 Thermo Fisher Scientific Inc Company Overview 32

5.13.1 Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.14 True Diagnostics Inc Company Overview 33

5.14.1 True Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 33

6 Drugs of Abuse / Toxicology Rapid Tests- Recent Developments 34

6.1 May 14, 2018: ABMC Reports First Quarter 2018 Results 34

6.2 Apr 27, 2018: Dimerix: Quarterly Review-Q3 FY2018 34

6.3 Feb 28, 2018: ALFA receives another US FDA 510(k) clearance for Simple Cup multi-drug test with Driven Flow 36

6.4 Nov 14, 2017: ABMC Reports Third Quarter 2017 Results 37

6.5 Aug 16, 2017: FDA Grants OTC Clearance for ABMC's Rapid TOX CUP II 37

6.6 Aug 14, 2017: ABMC Reports Second Quarter 2017 Results 38

6.7 Jul 19, 2017: Alere Launches Alere iCup Rx Drug Screen For Detecting Commonly Misused And Abused Prescription Drugs 38

7 Appendix 40

7.1 Methodology 40

7.2 About GlobalData 43

7.3 Contact Us 43

7.4 Disclaimer 43

List Of Figure

1.2 List of Figures

Figure 1: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Stage of Development 7

Figure 2: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Territory 8

Figure 3: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Regulatory Path 9

Figure 4: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Estimated Approval Date 10

List Of Table

1.1 List of Tables

Table 1: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Stage of Development 7

Table 2: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Territory 8

Table 3: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Regulatory Path 9

Table 4: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Estimated Approval Date 10

Table 5: Drugs of Abuse / Toxicology Rapid Tests Companies-Pipeline Products by Stage of Development 11

Table 6: Drugs of Abuse / Toxicology Rapid Tests-Pipeline Products by Stage of Development 12

Table 7: American Bio Medica Corp Pipeline Products & Ongoing Clinical Trials Overview 13

Table 8: Rapid Drug Screen-Nicotine-Product Status 13

Table 9: Rapid Drug Screen-Nicotine-Product Description 14

Table 10: Rapid ONE-Nicotine-Product Status 14

Table 11: Rapid ONE-Nicotine-Product Description 14

Table 12: Rapid TOX Cup II-CLIA-Product Status 15

Table 13: Rapid TOX Cup II-CLIA-Product Description 15

Table 14: Rapid TOX Cup II-Nicotine-Product Status 15

Table 15: Rapid TOX Cup II-Nicotine-Product Description 15

Table 16: RDS InCup-Nicotine-Product Status 16

Table 17: RDS InCup-Nicotine-Product Description 16

Table 18: Behavioral Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 17

Table 19: Epigenetic Alcohol Test-Product Status 17

Table 20: Epigenetic Alcohol Test-Product Description 17

Table 21: Bio-Alternative Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 18

Table 22: Digital Strip Reader-Drugs Of Abuse-Product Status 18

Table 23: Digital Strip Reader-Drugs Of Abuse-Product Description 18

Table 24: BioMedomics Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 25: Rapid Drug Overdose Test-Cocaine-Product Status 19

Table 26: Rapid Drug Overdose Test-Cocaine-Product Description 19

Table 27: Rapid Drug Overdose Test-Morphine-Product Status 20

Table 28: Rapid Drug Overdose Test-Morphine-Product Description 20

Table 29: Rapid Quantitative Acetaminophen Detection Assay-Product Status 20

Table 30: Rapid Quantitative Acetaminophen Detection Assay-Product Description 20

Table 31: Biosensia Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

Table 32: RapiPlex-Drugs Of Abuse Assay-Product Status 21

Table 33: RapiPlex-Drugs Of Abuse Assay-Product Description 21

Table 34: Dimerix Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

Table 35: VisuaLine Multi Dip Panel-Product Status 22

Table 36: VisuaLine Multi Dip Panel-Product Description 22

Table 37: Group K Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 23

Table 38: Multidiagnostic-Aflatoxin B1 Test-Product Status 23

Table 39: Multidiagnostic-Aflatoxin B1 Test-Product Description 23

Table 40: Multidiagnostic-Heavy Metals Test-Product Status 24

Table 41: Multidiagnostic-Heavy Metals Test-Product Description 24

Table 42: Multidiagnostic-Paraoxon Test-Product Status 24

Table 43: Multidiagnostic-Paraoxon Test-Product Description 25

Table 44: Multidiagnostic-Pentachlorophenol (PCP) Test-Product Status 25

Table 45: Multidiagnostic-Pentachlorophenol (PCP) Test-Product Description 25

Table 46: ImmunoScience Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Table 47: Salivax-Drug Of Abuse-Product Status 26

Table 48: Salivax-Drug Of Abuse-Product Description 26

Table 49: Quidel Corp Pipeline Products & Ongoing Clinical Trials Overview 27

Table 50: Sofia-Toxicology Assay-Product Status 27

Table 51: Sofia-Toxicology Assay-Product Description 27

Table 52: Triage-Toxicology Assay-Product Status 28

Table 53: Triage-Toxicology Assay-Product Description 28

Table 54: Rapid Pathogen Screening Inc Pipeline Products & Ongoing Clinical Trials Overview 29

Table 55: OrganoTox-Product Status 29

Table 56: OrganoTox-Product Description 29

Table 57: Seacoast Science, Inc. Pipeline Products & Ongoing Clinical Trials Overview 30

Table 58: Point-Of-Care Drug Screen Test-Product Status 30

Table 59: Point-Of-Care Drug Screen Test-Product Description 30

Table 60: The University of South Australia Pipeline Products & Ongoing Clinical Trials Overview 31

Table 61: Point-Of-Care Test-Drug Of Abuse-Product Status 31

Table 62: Point-Of-Care Test-Drug Of Abuse-Product Description 31

Table 63: Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 64: Point-Of-Care Platform-Drugs Of Abuse Assay-Product Status 32

Table 65: Point-Of-Care Platform-Drugs Of Abuse Assay-Product Description 32

Table 66: True Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Table 67: TrueDX-Drug Of Abuse Test-Product Status 33

Table 68: TrueDX-Drug Of Abuse Test-Product Description 33

Table 69: Glossary 42

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