Published : Nov-2019
No. of Pages : 81
1.1 List of Tables 4
1.2 List of Figures 5
2 Introduction 6
2.1 Self Testing Overview 6
3 Products under Development 7
3.1 Self Testing - Pipeline Products by Stage of Development 7
3.2 Self Testing - Pipeline Products by Territory 8
3.3 Self Testing - Pipeline Products by Regulatory Path 9
3.4 Self Testing - Pipeline Products by Estimated Approval Date 10
3.5 Self Testing - Ongoing Clinical Trials 11
4 Self Testing - Pipeline Products under Development by Companies 12
4.1 Self Testing Companies - Pipeline Products by Stage of Development 12
4.2 Self Testing - Pipeline Products by Stage of Development 13
5 Self Testing Companies and Product Overview 14
5.1 Atomo Diagnostics Pty Ltd Company Overview 14
5.1.1 Atomo Diagnostics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 14
5.2 bioLytical Laboratories Inc Company Overview 18
5.2.1 bioLytical Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 18
5.3 Boston Microfluidics Company Overview 20
5.3.1 Boston Microfluidics Pipeline Products & Ongoing Clinical Trials Overview 20
5.4 Brigham and Women's Hospital Company Overview 21
5.4.1 Brigham and Women's Hospital Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 Emory University Company Overview 22
5.5.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 22
5.6 Entia Ltd Company Overview 23
5.6.1 Entia Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
5.7 InnaMed Inc Company Overview 24
5.7.1 InnaMed Inc Pipeline Products & Ongoing Clinical Trials Overview 24
5.8 Morgan Innovation And Technology Ltd Company Overview 26
5.8.1 Morgan Innovation And Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
5.9 Novosanis NV Company Overview 27
5.9.1 Novosanis NV Pipeline Products & Ongoing Clinical Trials Overview 27
5.10 OncoGenesis Company Overview 28
5.10.1 OncoGenesis Pipeline Products & Ongoing Clinical Trials Overview 28
5.11 Premier Medical Corporation Company Overview 29
5.11.1 Premier Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 29
5.12 Shanghai Kehua Bio-engineering Co Ltd Company Overview 30
5.12.1 Shanghai Kehua Bio-engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 30
5.13 Svenska Cellulosa Aktiebolaget Company Overview 31
5.13.1 Svenska Cellulosa Aktiebolaget Pipeline Products & Ongoing Clinical Trials Overview 31
5.14 Tasso, Inc. Company Overview 32
5.14.1 Tasso, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
5.15 Wellmetrix LLC Company Overview 33
5.15.1 Wellmetrix LLC Pipeline Products & Ongoing Clinical Trials Overview 33
6 Self Testing- Recent Developments 34
6.1 Sep 10, 2019: EKF Diagnostics Holdings: Half-year Report 34
6.2 Aug 19, 2019: Retirement of Dr. Sandra Horning & Appointment of Dr. Levi Garraway to Chief Medical Officer, Roche and Genentech 35
6.3 Aug 12, 2019: Biocept reports second quarter 2019 financial results 35
6.4 Jul 25, 2019: Roche reports very strong performance in the first half of 2019 - Outlook raised 37
6.5 Jul 15, 2019: EKF Diagnostics Holdings: Trading update 41
6.6 Jul 09, 2019: Mylan HIV Self Test receives WHO prequalification approval 42
6.7 Jun 14, 2019: Klobuchar, Murkowski introduce Legislation to Protect Consumers' Private Health Data 42
6.8 Jun 11, 2019: Changes in Roche's board of directors and corporate executive committee 44
6.9 Jun 11, 2019: Regulators demand more details on Roche's $4.8bn Spark acquisition 45
6.10 May 08, 2019: Biocept reports first quarter 2019 financial results 45
6.11 Apr 25, 2019: Regarding the establishment of the new "EIKEN ROAD MAP 2019" management framework and the new medium-term management plan 47
6.12 Apr 25, 2019: Eiken Chemical announced its financial results for the fiscal year ended March 31, 2019 49
6.13 Apr 17, 2019: Roche reports a strong start in 2019 and raises the outlook for the full-year 49
6.14 Apr 04, 2019: First HIV self-test approved for sale in Australia now available from Atomo Diagnostics 52
6.15 Mar 28, 2019: Biocept reports 2018 fourth quarter and full year financial results 53
6.16 Mar 21, 2019: Roche sues U.S. executives in fight over diabetes test strips 57
6.17 Mar 13, 2019: EKF Diagnostics Holdings: Final results 57
6.18 Feb 27, 2019: Biocept and Providence Saint John's Health Center collaborate to evaluate cerebrospinal fluid for use with liquid biopsy testing in metastatic cancer 62
6.19 Jan 31, 2019: Roche reports very strong results in 2018 63
6.20 Jan 24, 2019: Genentech announces Alexander Hardy as Chief Executive Officer 67
6.21 Jan 11, 2019: Shimadzu's new preparative purification LC System provides high efficiency, saves space, and enables multi-sample processing 68
6.22 Jan 07, 2019: MES to launch the first YO Home Sperm Test for PCs with personalized YO SCORE 69
6.23 Jan 02, 2019: Roche Diabetes Care India appoints Dr. Gaurav Laroia as general manager 70
6.24 Dec 13, 2018: Devicare announces the positive results of the clinical trial with Lit-Control to prevent the encrustation of catheters in patients with lithiasis 70
6.25 Dec 11, 2018: Brigham researchers develop smartphone-based Ovulation Test 71
6.26 Dec 10, 2018: New member proposed for election to Roche Board of Directors 72
6.27 Dec 10, 2018: Roche names William Bill Anderson as CEO from January 01 2019 72
6.28 Dec 03, 2018: Roche to increase its payroll in Switzerland by 1.2 percent 73
6.29 Nov 30, 2018: European Patent granted for Colli-Pee 73
6.30 Nov 29, 2018: Australian TGA approves Atomo HIV Self Test as first rapid diagnostic test for home use 73
6.31 Nov 28, 2018: INSTI HIV Self Test earns WHO prequalification status for home testing 74
6.32 Nov 08, 2018: Colli-Pee approved by Mexican Health Authority 75
6.33 Oct 31, 2018: Biocept announces new executive hires to its sales and marketing organization 76
6.34 Oct 25, 2018: Exeltis Spain launches the world's first ever digital urology solution 77
7 Appendix 78
7.1 Methodology 78
7.2 About GlobalData 81
7.3 Contact Us 81
7.4 Disclaimer 81
List of Tables
Table 1: Self Testing - Pipeline Products by Stage of Development 7
Table 2: Self Testing - Pipeline Products by Territory 8
Table 3: Self Testing - Pipeline Products by Regulatory Path 9
Table 4: Self Testing - Pipeline Products by Estimated Approval Date 10
Table 5: Self Testing - Ongoing Clinical Trials 11
Table 6: Self Testing Companies - Pipeline Products by Stage of Development 12
Table 7: Self Testing - Pipeline Products by Stage of Development 13
Table 8: Atomo Diagnostics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 14
Table 13: bioLytical Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 18
Table 16: Boston Microfluidics Pipeline Products & Ongoing Clinical Trials Overview 20
Table 19: Brigham and Women's Hospital Pipeline Products & Ongoing Clinical Trials Overview 21
Table 22: Emory University Pipeline Products & Ongoing Clinical Trials Overview 22
Table 25: Entia Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
Table 28: InnaMed Inc Pipeline Products & Ongoing Clinical Trials Overview 24
Table 35: Morgan Innovation And Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
Table 38: Novosanis NV Pipeline Products & Ongoing Clinical Trials Overview 27
Table 41: OncoGenesis Pipeline Products & Ongoing Clinical Trials Overview 28
Table 44: Premier Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 29
Table 47: Shanghai Kehua Bio-engineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 30
Table 50: Svenska Cellulosa Aktiebolaget Pipeline Products & Ongoing Clinical Trials Overview 31
Table 53: Tasso, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
Table 56: Wellmetrix LLC Pipeline Products & Ongoing Clinical Trials Overview 33
Table 59: Glossary 80
List of Figures
Figure 1: Self Testing - Pipeline Products by Stage of Development 7
Figure 2: Self Testing - Pipeline Products by Territory 8
Figure 3: Self Testing - Pipeline Products by Regulatory Path 9
Figure 4: Self Testing - Pipeline Products by Estimated Approval Date 10
Figure 5: Self Testing - Ongoing Clinical Trials 11
