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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 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.

MDxHealth SA Announces Consolidated Results of the First Half Year Ended June 30, 2014

MDxHealth SA announced consolidated results of the first half year ended June 30, 2014. For the period, the company reported total revenues of $4,804,000 against $3,984,000 a year ago. LBITDA was $7,932,000 against $7,525,000 a year ago. Operating loss was $8,086,000 against $7,820,000 a year ago. Net loss was $8,043,000 or $0.23 per basic share against $7,843,000 or $0.23 per basic share a year ago. Loss increased slightly over the same period in 2013 due to costs associated with growing commercial infrastructure to support U.S. sales and marketing and new product R&D investment.

MDxHealth SA ConfirmMDx Biomarker Associates with the Risk of Recurrence for Early Stage Prostate Cancer Patients

MDxHealth SA announced that one of the ConfirmMDx(R) for Prostate Cancer epigenetic genes is independently associated with risk of recurrence in patients with early prostate cancer (PCa). The results from this study, published in The Journal of Urology(R), suggest that epigenetic analysis could play a clinical role in identifying patients who have a slow growing cancer eligible for active surveillance from those with a higher risk of recurrence who may benefit from a more aggressive therapeutic approach. One of the most significant challenges in diagnosing early stage PCa is proper staging and grading of the patients in order to choose the best treatment plan. Current methods such as clinical staging, PSA serum level and biopsy tissue Gleason score are helpful, but have limited prognostic value. Therefore, more accurate and objective prediction of PCa disease recurrence is very important. The gene glutathione S-transferase Pi 1 (GSTP1) is one of the three genes in the ConfirmMDx test and previous studies have indicated that this gene has been associated with different stages of PCa. The study, conducted by researchers from Johns Hopkins University Medical Center, evaluated the prognostic value of nine epigenetic genes using tissue from 452 patients (259 cases, 193 controls) presenting with biochemical recurrence, clinical recurrence, systemic metastases, or who died of their prostate cancer in a nested case-control study of patients surgically treated for clinically localized PCa. Out of the nine genes, the data showed that higher GSTP1 methylation was the only one significantly associated with an increased risk of recurrence, especially for men with early stage PCa.


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