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mdxhealth (MDXH) Details

MDxHealth SA, a molecular diagnostics company, develops and commercializes epigenetic assays and services for cancer assessment, and the personalized treatment of patients. It offers clinical molecular diagnostics solutions that provide physicians with tests for the identification and treatment of their cancer patients; and pharmaco molecular diagnostics solutions for the development of companion diagnostics, biomarker discovery, and clinical trial testing. The company’s product pipeline consists of ConfirmMDx that serve as an aid for physicians to assess DNA methylation status associated with presence or absence of cancer; and InformMDx, which provide prognostic assessment to distinguish between aggressive and non-aggressive tumors. Its products also comprise PredictMDx that offer predictive information to indicate drugs or treatment regimens that are to be most effective for the individual patient; and ClinicalMDx assays that are designed to aid in the assessment of the presence or absence of cancer, or provide indications of cancer recurrence or aggressiveness in the areas of prostate, colorectal, and lung cancer. The company was formerly known as OncoMethylome Sciences SA and changed its name to MDxHealth SA on October 2010. MDxHealth SA was founded in 2003 and is headquartered in Herstal, Belgium.

84 Employees
Last Reported Date: 04/30/14
Founded in 2003

mdxhealth (MDXH) Top Compensated Officers

Chief Executive Officer and Executive Directo...
Total Annual Compensation: €470.7K
Compensation as of Fiscal Year 2013.

mdxhealth (MDXH) Key Developments

MDxHealth SA and Miraca Life Sciences Announce Agreement to Promote ConfirmMDx(R) for Prostate Cancer

MDxHealth SA announced that it has entered into an agreement with Miraca Life Sciences to promote MDxHealth's ConfirmMDx(R) for Prostate Cancer test. Serving more than 5,500 patients each day, Miraca Life Sciences is a national leader in providing academic-caliber pathology services in the fields of dermatology, hematology, gastroenterology and urology. Over 975,000 American men receive a negative prostate biopsy result each year, though approximately 25% of these men may still harbor occult prostate cancer. This well-documented risk of undetected cancer, often with clinically significant Gleason scores, leads to a high rate of repeat biopsies with greater than 40% of men receiving at least one repeat biopsy, and many receiving a 3rd and 4th biopsy. Today's gold standard diagnostic approach is the prostate biopsy procedure, collecting 10-12 needle core biopsy samples; however this sampling represents less than 1% of a man's prostate. ConfirmMDx for Prostate Cancer is an epigenetic assay to help urologists distinguish patients who have a true-negative biopsy from those at risk for undetected cancer. The test is able to detect an epigenetic field effect or "halo" associated with the cancerization process at the DNA level. This molecular "halo" around a cancer lesion can be present despite having a normal appearance under the microscope. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and rule in high-risk patients who may require repeat biopsies and potential treatment. Performance of the proprietary ConfirmMDx genes and technology has been published in 42 studies with over 4,100 patients tested.

MDxHealth SA, Annual General Meeting, May 30, 2014

MDxHealth SA, Annual General Meeting, May 30, 2014., at 10:00 Central European Standard Time. Location: Regus Brussels Airport Meeting Center. Agenda: To reports on the annual statutory financial statements and on the consolidated financial statements for the financial year ended on December 31, 2013; to approve the annual statutory financial statements for the financial year ended on December 31, 2013; to consider communication of, and discussion on, the consolidated financial statements of the company for the financial year ended on December 31, 2013; to consider discharge from liability of the directors and the statutory auditor; to consider the remuneration report; to consider the appointment of directors; and to consider the remuneration of directors.

MDxHealth SA Announces Presentations on ConfirmMDx for Prostate Cancer at American Urological Association 2014 Annual Meeting

MDxHealth SA announced that results from its pivotal clinical validation study for ConfirmMDx(R) for Prostate Cancer will be highlighted in two oral presentations and separately, the test will be featured in a prostate cancer biomarker symposium at the upcoming American Urology Association 2014 Annual Meeting in Orlando, Florida. The first two presentations will be delivered by Alan Partin, MD, PhD, Professor and Chief of Urology at the James Buchanan Brady Urological Institute at Johns Hopkins School of Medicine. Dr. Partin will present results of the multicenter DOCUMENT (Detection of Occult Cancer Using Methylated Events in Negative Tissue) validation study. The DOCUMENT study validates the ConfirmMDx for Prostate Cancer test as the most significant predictor of risk for the presence of occult cancer above any other risk factor used to guide the decision for repeat biopsy. The study further validates that the ConfirmMDx test provides actionable information to improve patient risk stratification men and aid urologists to differentiate prostate-cancer-free men who may avoid unnecessary repeat biopsies from those who may harbor undetected prostate cancer and who merit early repeat biopsy. The first presentation will be an oral presentation at a satellite symposium of the AUA hosted by British Association of Urologic Surgeons International/Urological Society of Australia and New Zealand. The second presentation is part of a moderated poster Session at the AUA entitled ‘Prostate Cancer: Detection & Screening’. The prostate cancer biomarker symposium, which is supported by the Prostate Conditions Education Council, will review the clinical utility of several promising molecular tests, and will feature ConfirmMDx for Prostate Cancer.


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