Self Testing - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 4

2 Introduction 5

2.1 Self Testing Overview 5

3 Products under Development 6

3.1 Self Testing-Pipeline Products by Stage of Development 6

3.2 Self Testing-Pipeline Products by Territory 7

3.3 Self Testing-Pipeline Products by Regulatory Path 8

3.4 Self Testing-Pipeline Products by Estimated Approval Date 9

4 Self Testing-Pipeline Products under Development by Companies 10

4.1 Self Testing Companies-Pipeline Products by Stage of Development 10

4.2 Self Testing-Pipeline Products by Stage of Development 11

5 Self Testing Companies and Product Overview 12

5.1 Atomo Diagnostics Pty Limited Company Overview 12

5.2 Boston Microfluidics Company Overview 13

5.3 Entia Ltd Company Overview 14

5.4 Morgan Innovation And Technology Ltd Company Overview 15

5.5 Novosanis NV Company Overview 16

5.6 OncoGenesis Company Overview 17

5.7 Premier Medical Corporation Company Overview 18

5.8 Shanghai Kehua Bio-engineering Co Ltd Company Overview 19

5.9 Svenska Cellulosa Aktiebolaget Company Overview 20

5.10 Wellmetrix LLC Company Overview 21

6 Self Testing- Recent Developments 22

6.1 May 29, 2018: A study published in 'Journal of Endourology' certifies that Lit-Control is the best method to control urinary pH 22

6.2 May 15, 2018: Biocept Announces First Quarter 2018 Financial Results 22

6.3 Apr 26, 2018: Roche reports a strong start in 2018 24

6.4 Apr 25, 2018: NanoRepro Increases Sales and Achieves Positive Operating Result (EBITDA) 26

6.5 Apr 12, 2018: Using a Home Test Kit and Smartphone to Test for Kidney Disease 26

6.6 Apr 10, 2018: NanoRepro Reaches Its Annual Targets and Wants to Grow Strongly in 2018 27

6.7 Mar 30, 2018: Novosanis' medical device Colli-Pee prefilled with urine preservative now CE-certified 28

6.8 Mar 28, 2018: Biocept Reports 2017 Fourth Quarter and Full Year Financial Results 28

6.9 Mar 14, 2018: EKF Diagnostics Holdings: 2017 Final results 32

6.10 Mar 08, 2018: Changes to the Roche Enlarged Corporate Executive Committee 36

6.11 Feb 20, 2018: At-Home Genetic Testing Leads to Misinterpretations of Results 37

6.12 Feb 01, 2018: Roche reports good results in 2017 38

6.13 Jan 11, 2018: Innovus Pharma Announces U.S. Food and Drug Administration Clearance of Its UriVarx Urinary Tract Infection Test Strips 38

6.14 Dec 07, 2017: Expert Review Panel for Diagnostics Approves Atomo HIV Self Test for Procurement by Unitaid and the Global Fund 39

6.15 Dec 05, 2017: NanoRepro With Higher Sales and Better Results 40

6.16 Nov 17, 2017: Shimadzu Promotes the Creation of Products Using Key Technologies Through Joint Research and Development Innovation Centre in Singapore in Operation 40

6.17 Nov 09, 2017: Biocept Reports Third Quarter 2017 Financial Results 41

6.18 Nov 02, 2017: COSMED announces the incorporation of COSMED Benelux 44

6.19 Oct 19, 2017: Devicare Ushers in Lit-Control to the United Kingdom 44

6.20 Oct 19, 2017: Roche reports strong sales growth in the first nine months of 2017 45

6.21 Oct 11, 2017: Renowned Lung Cancer Expert Fred R. Hirsch, M.D., Ph.D. Joins Biocept's Clinical Advisory Board 49

6.22 Oct 10, 2017: CE Marking for world's only integrated HIV Self-Test from Atomo Diagnostics gives access to safe, accurate and reliable self-testing 49

6.23 Sep 29, 2017: Alere Announces the U.S. Department of Justice Closes Investigation 50

6.24 Sep 28, 2017: Alere Announces Settlement with SEC 50

6.25 Sep 19, 2017: Ixcela Launches Over-the-Counter Gut Health Test and Sophisticated Internal Wellness Program 50

6.26 Sep 14, 2017: BioIQ Announces the Appointment of Sherman Sanchez as Senior Vice President, Sales and Business Development 51

6.27 Sep 11, 2017: EKF Diagnostics Holdings: Half Yearly Report 52

6.28 Sep 07, 2017: Roche ranked again the most sustainable healthcare company in the Dow Jones Sustainability Indices 52

6.29 Sep 06, 2017: Auto Control Medical Partners with STI's innoviCares Program to Lower Cost of Home Diabetes Testing in Canada 53

6.30 Aug 22, 2017: MHRA Seizes More than 100 Unreliable HIV Home-testing Kits 54

6.31 Aug 10, 2017: Biocept Reports Second Quarter 2017 Financial Results 55

6.32 Aug 03, 2017: Alere Reports Second Quarter 2017 Financial Results 57

6.33 Aug 03, 2017: NanoRepro Increases Growth in the Second Quarter 58

6.34 Jul 28, 2017: Instant HIV home test launched in the Netherlands 58

6.35 Jul 28, 2017: INSTI HIV Self Test detects HIV two weeks sooner than other brands 59

6.36 Jul 27, 2017: INSTI HIV Self Test Demonstrates High User Acceptance in Kenya Study 59

6.37 Jul 27, 2017: Roche reports strong performance in the first half of 2017 60

6.38 Jul 06, 2017: INSTI HIV Self Test Receives Global Fund Classification for Procurement 62

7 Appendix 63

7.1 Methodology 63

7.2 About GlobalData 66

7.3 Contact Us 66

7.4 Disclaimer 66

List of Figure

1.2 List of Figures

Figure 1: Self Testing-Pipeline Products by Stage of Development 6

Figure 2: Self Testing-Pipeline Products by Territory 7

Figure 3: Self Testing-Pipeline Products by Regulatory Path 8

Figure 4: Self Testing-Pipeline Products by Estimated Approval Date 9

List of Table

1.1 List of Tables

Table 1: Self Testing-Pipeline Products by Stage of Development 6

Table 2: Self Testing-Pipeline Products by Territory 7

Table 3: Self Testing-Pipeline Products by Regulatory Path 8

Table 4: Self Testing-Pipeline Products by Estimated Approval Date 9

Table 5: Self Testing Companies-Pipeline Products by Stage of Development 10

Table 6: Self Testing-Pipeline Products by Stage of Development 11

Table 7: Atomo Diagnostics Pty Limited Pipeline Products & Ongoing Clinical Trials Overview 12

Table 8: Atomo HIV Self Test-Product Status 12

Table 9: Atomo HIV Self Test-Product Description 12

Table 10: Boston Microfluidics Pipeline Products & Ongoing Clinical Trials Overview 13

Table 11: Knownow-Product Status 13

Table 12: Knownow-Product Description 13

Table 13: Entia Ltd Pipeline Products & Ongoing Clinical Trials Overview 14

Table 14: Affinity-Product Status 14

Table 15: Affinity-Product Description 14

Table 16: Morgan Innovation And Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 15

Table 17: Salurate Test-Product Status 15

Table 18: Salurate Test-Product Description 15

Table 19: Novosanis NV Pipeline Products & Ongoing Clinical Trials Overview 16

Table 20: Next-Generation Colli-Pee-Product Status 16

Table 21: Next-Generation Colli-Pee-Product Description 16

Table 22: OncoGenesis Pipeline Products & Ongoing Clinical Trials Overview 17

Table 23: iPap Personal Pap Test Specimen Self Collector-Product Status 17

Table 24: iPap Personal Pap Test Specimen Self Collector-Product Description 17

Table 25: Premier Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 18

Table 26: Second Generation HIV Rapid Detection Test-Product Status 18

Table 27: Second Generation HIV Rapid Detection Test-Product Description 18

Table 28: Shanghai Kehua Bio-engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 19

Table 29: Third Generation HIV Rapid Detection Test-Product Status 19

Table 30: Third Generation HIV Rapid Detection Test-Product Description 19

Table 31: Svenska Cellulosa Aktiebolaget Pipeline Products & Ongoing Clinical Trials Overview 20

Table 32: U-Check Alarm-Product Status 20

Table 33: U-Check Alarm-Product Description 20

Table 34: Wellmetrix LLC Pipeline Products & Ongoing Clinical Trials Overview 21

Table 35: WellMetrix Test-Product Status 21

Table 36: WellMetrix Test-Product Description 21

Table 37: Glossary 65