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03/19/14 - €5.29
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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 Grants Limited Worldwide License for its Patented Methylation Specific PCR Technology to oncgnostics GmbH in Jena

MDxHealth SA has granted a limited worldwide license for its patented methylation specific PCR (MSP) technology to oncgnostics GmbH in Jena, Germany. Under the agreement, MDxHealth grants oncgnostics a limited, non-transferable, non-exclusive, worldwide license for its patented methylation specific PCR (MSP) technology for diagnostic applications in cervical cancer. In return, MDxHealth will receive upfront and milestone payments, and royalties on net sales.

MDxHealth SA Announces Unaudited Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014

MDxHealth SA announced unaudited earnings results for the third quarter and nine months ended September 30, 2014. In the third quarter of 2014, the company’s revenue grew 93% to $3.1 million, versus the $1.6 million recorded in the third quarter of 2013. The gain is driven by continuing adoption of the ConfirmMDx test by the U.S. urology community, with over 3,500 patient tests in the third quarter of 2014, and more than 9,000 tests performed year to date. LBITDA was $3,465,000 against $3,895,000 a year ago. LBIT was $3,552,000 against $3,953,000 a year ago. Net loss was $4,193,000 against $3,945,000 a year ago. The company’s total revenues for the first nine months amounted to $8.3 million, a 39% growth over the previous year, primarily due to an increase in ConfirmMDx test sales, which grew by 175% during the same period. The net loss was $12.2 million for the first nine months of 2014 increased by $0.45 million compared to the same period last year. Continued investment in the US commercial operation and higher cost of sales due to the increasing test volumes for the ConfirmMDx for Prostate Cancer test were offset by higher recognized revenue from its sale. LBITDA was $11,398,000 against $11,420,000 a year ago. LBIT was $11,637,000 against $11,772,000 a year ago.

MDxHealth SA Announces Positive Data from an Important Study Confirming the Ability of the Confirmmdx Genes to Identify Prostate Cancer

MDxHealth SA announced positive data from an important study confirming the ability of the ConfirmMDx(R) genes to identify prostate cancer (PCa) aggressiveness in diagnostic biopsies. The data, presented at the European Association of Urology, Section Urological Research (ESUR) meeting in Glasgow, UK (October 9-11, 2014), confirmed that the epigenetic profile of ConfirmMDx genes generated by the test is strongly correlated with established risk stratification metrics, such as Gleason Score (GS) and the NCCN (National Comprehensive Cancer Network) risk categories. These data demonstrate that ConfirmMDx for Prostate Cancer not only provides important diagnostic information to help guide the decision on repeat biopsy, but that the genes may also deliver significant prognostic value, potentially determining whether a man has an aggressive or non-aggressive form of prostate cancer. In this study, hypermethylation levels of the three ConfirmMDx genes (GSTP1, APC and RASSF1) were evaluated on biopsies from 102 men with various GS (ranging from 3+3 to 4+4) and NCCN (ranging from very low to high) risk profiles. All men had undergone a 12-core prostate biopsy under routine clinical practice resulting in their PCa diagnosis. No epigenetic aberrations for any of these three genes were found in 20 control patients, who had non-cancer histology in all of their 12-core biopsy specimens. For 46 men, the observed GS was 6, classifying these men as potential candidates for active surveillance; however, 17% (n=8) of them exhibited an epigenetic profile that is indicative of higher-grade disease. Of the nine men with GS 4+3 or higher, 88% (n=8) had many epigenetic aberrations, in addition to 17 out of 27 (63%) of the men with GS 3+4.


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