MDxHealth SA (MDXH) - Product Pipeline Analysis, 2018 Update

Summary

MDxHealth SA (MDxHealth) develops and commercializes advanced epigenetic and other molecular tests for cancer assessment and the personalized treatment of patients. The companys products portfolio includes ConfirmMDx, which detects absence or presence of prostate cancer; SelectMDx for prostate cancer; and AssureMDx for bladder cancer. Its pipeline products include InformMDx, SelectMDx (Point of Care) and MonitorMDx which is being developed for Prostate Cancer Test. MdxHealth tests are based on MSP (Methylation-Specific polymerase chain reaction) technology, a proprietary DNA-based platform. It also offers biomarker development services to many pharmaceutical companies. MDxHealth markets its products through sales forces, partnerships and distributors. The company has operations in, the Netherlands, Belgium and the US. MDxHealth is headquartered in Herstal, Liege, Belgium.

This report is a source for data, analysis, and actionable intelligence on the companys portfolio of pipeline products. The report provides key information about the company, its major products and brands.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage.

Scope:

- The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments
- The report analyzes all pipeline products in development for the company MDxHealth SA
- The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status)
- The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date
- The report provides detailed description of products in development, technical specification and functions
- The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date.

Reasons to Buy:

- Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape
- Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio
- To formulate effective Research & Development strategies
- Develop market-entry and market expansion strategies
- Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Develop competition strategies by identifying the status and likely launch of the competitors pipeline products through review of the clinical trials, stage and of development, etc
- Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio



List of Tables 4
List of Figures 5
MDxHealth SA Company Overview 6
MDxHealth SA Company Snapshot 6
MDxHealth SA Pipeline Products and Ongoing Clinical Trials Overview 6
MDxHealth SA Pipeline Analysis Overview 9
Business Description 9
MDxHealth SA - Key Facts 10
MDxHealth SA - Major Products and Services 11
MDxHealth SA Pipeline Products by Development Stage 12
MDxHealth SA Ongoing Clinical Trials by Trial Status 14
MDxHealth SA Pipeline Products Overview 15
(Epi)genetic Diagnostic Assay - Kidney Cancer 15
(Epi)genetic Diagnostic Assay - Kidney Cancer Product Overview 15
Bladder ConfirmMDx 16
Bladder ConfirmMDx Product Overview 16
Bladder RecurMdx 17
Bladder RecurMdx Product Overview 17
ClinicalMDx - Cervical Cancer 18
ClinicalMDx - Cervical Cancer Product Overview 18
ConfirmMDx - Prostate Cancer 19
ConfirmMDx - Prostate Cancer Product Overview 19
ConfirmMDx - Prostate Cancer Clinical Trial 20
ConfirmMDx Lung Cancer Test 21
ConfirmMDx Lung Cancer Test Product Overview 21
Diagnostic Test - Urologic Cancer 22
Diagnostic Test - Urologic Cancer Product Overview 22
Epigenetic Biomarker Test - Prostate Cancer 23
Epigenetic Biomarker Test - Prostate Cancer Product Overview 23
InformMDx - Colon Cancer 24
InformMDx - Colon Cancer Product Overview 24
InformMDx - Prostate Cancer CLIA Test 25
InformMDx - Prostate Cancer CLIA Test Product Overview 25
InformMDx Prognostic Test - Prostate Cancer 26
InformMDx Prognostic Test - Prostate Cancer Product Overview 26
Liquid Biopsy Epigenetic Assay - Oral Cancer 27
Liquid Biopsy Epigenetic Assay - Oral Cancer Product Overview 27
Molecular Diagnostic Test - Bladder Cancer 28
Molecular Diagnostic Test - Bladder Cancer Product Overview 28
MonitorMDx - Prostate Cancer 29
MonitorMDx - Prostate Cancer Product Overview 29
PharmacoDx - Breast Cancer 30
PharmacoDx - Breast Cancer Product Overview 30
PharmacoDx - Lung Cancer 31
PharmacoDx - Lung Cancer Product Overview 31
PharmacoDx - Ovarian Cancer 32
PharmacoDx - Ovarian Cancer Product Overview 32
PredictMDx - Colon Cancer 33
PredictMDx - Colon Cancer Product Overview 33
RecurMDx - Prostate Cancer 34
RecurMDx - Prostate Cancer Product Overview 34
MDxHealth SA - Key Competitors 35
MDxHealth SA - Key Employees 36
MDxHealth SA - Key Employee Biographies 37
MDxHealth SA - Locations And Subsidiaries 38
Head Office 38
Other Locations & Subsidiaries 38
Recent Developments 39
MDxHealth SA, Recent Developments 39
Jul 23, 2018: MDxHealth: Medicare Establishes Final Positive Local Coverage Determination for Use of ConfirmMDx for Prostate Cancer 39
Jun 27, 2018: MDxHealths SelectMDx Test Successfully Stratifies Men Who May Benefit from mp-MRI 39
May 22, 2018: Presentation of New Data on MDxHealths Prostate and Bladder Cancer Products at AUA 2018 Annual Meeting 40
Apr 27, 2018: MDxHealth releases 2017 Annual Report 41
Apr 26, 2018: MDxHealth Announces Positive Clinical Updates for ConfirmMDx 41
Apr 24, 2018: MDxHealth Reports First Quarter 2018 Financial Results 42
Apr 20, 2018: MDxHealth: SelectMDx Included in Dutch DRG Reimbursement System 43
Mar 22, 2018: MDxHealth Successfully Completes a EUR 36 Million (USD 44 million)(1) Capital Increase 44
Mar 19, 2018: MDxHealth: SelectMDx Liquid Biopsy Test for Prostate Cancer included in the 2018 European Association Urology Guidelines 44
Feb 28, 2018: MDxHealth contract SelectMDx with Roman Hospital 45
Appendix 46
Methodology 46
About GlobalData 49
Contact Us 49
Disclaimer 49

List Of Tables


MDxHealth SA Pipeline Products and Ongoing Clinical Trials Overview 6
MDxHealth SA Pipeline Products by Equipment Type 7
MDxHealth SA Pipeline Products by Indication 8
MDxHealth SA Ongoing Clinical Trials by Trial Status 8
MDxHealth SA, Key Facts 10
MDxHealth SA, Major Products and Services 11
MDxHealth SA Number of Pipeline Products by Development Stage 12
MDxHealth SA Pipeline Products Summary by Development Stage 13
MDxHealth SA Ongoing Clinical Trials by Trial Status 14
MDxHealth SA Ongoing Clinical Trials Summary 14
(Epi)genetic Diagnostic Assay - Kidney Cancer - Product Status 15
(Epi)genetic Diagnostic Assay - Kidney Cancer - Product Description 15
Bladder ConfirmMDx - Product Status 16
Bladder ConfirmMDx - Product Description 16
Bladder RecurMdx - Product Status 17
Bladder RecurMdx - Product Description 17
ClinicalMDx - Cervical Cancer - Product Status 18
ClinicalMDx - Cervical Cancer - Product Description 18
ConfirmMDx - Prostate Cancer - Product Status 19
ConfirmMDx - Prostate Cancer - Product Description 19
ConfirmMDx - Prostate Cancer - ConfirmMDx Assay is Multiparametric MRI (mpMRI) PIRADS Scored Lesions after a Negative MR/US Fusion Biopsy 20
ConfirmMDx - Prostate Cancer - Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study 20
ConfirmMDx Lung Cancer Test - Product Status 21
ConfirmMDx Lung Cancer Test - Product Description 21
Diagnostic Test - Urologic Cancer - Product Status 22
Diagnostic Test - Urologic Cancer - Product Description 22
Epigenetic Biomarker Test - Prostate Cancer - Product Status 23
Epigenetic Biomarker Test - Prostate Cancer - Product Description 23
InformMDx - Colon Cancer - Product Status 24
InformMDx - Colon Cancer - Product Description 24
InformMDx - Prostate Cancer CLIA Test - Product Status 25
InformMDx - Prostate Cancer CLIA Test - Product Description 25
InformMDx Prognostic Test - Prostate Cancer - Product Status 26
InformMDx Prognostic Test - Prostate Cancer - Product Description 26
Liquid Biopsy Epigenetic Assay - Oral Cancer - Product Status 27
Liquid Biopsy Epigenetic Assay - Oral Cancer - Product Description 27
Molecular Diagnostic Test - Bladder Cancer - Product Status 28
Molecular Diagnostic Test - Bladder Cancer - Product Description 28
MonitorMDx - Prostate Cancer - Product Status 29
MonitorMDx - Prostate Cancer - Product Description 29
PharmacoDx - Breast Cancer - Product Status 30
PharmacoDx - Breast Cancer - Product Description 30
PharmacoDx - Lung Cancer - Product Status 31
PharmacoDx - Lung Cancer - Product Description 31
PharmacoDx - Ovarian Cancer - Product Status 32
PharmacoDx - Ovarian Cancer - Product Description 32
PredictMDx - Colon Cancer - Product Status 33
PredictMDx - Colon Cancer - Product Description 33
RecurMDx - Prostate Cancer - Product Status 34
RecurMDx - Prostate Cancer - Product Description 34
MDxHealth SA, Key Employees 36
MDxHealth SA, Key Employee Biographies 37
MDxHealth SA, Subsidiaries 38
Glossary 48

List Of Figures


MDxHealth SA Pipeline Products by Equipment Type 7
MDxHealth SA Pipeline Products by Development Stage 12
MDxHealth SA Ongoing Clinical Trials by Trial Status 14

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