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MDxHealth SA Announces Results from ConfirmMDx(TM) for Prostate Cancer Test Studies


Sunday, 17 Feb 2013 07:00pm EST 

MDxHealth SA announced the results of two studies of the ConfirmMDx(TM) for Prostate Cancer test presented at the ASCO Genitourinary Cancers Symposium 2013, February 14-16, 2013 Orlando, Florida, United States. In the Epigenetic Field Effect study in Histologically Benign Prostate Biopsy Cores it was shown that GSTP1, APC and/or RASSF1 gene promoter methylation is more prevalent in histologically benign cores from prostate cancer (PCa) patients diagnosed with Gleason Score (GS) 7 PCa, as compared with low volume GS 6. This study confirms previous findings in a larger cohort of subjects that these "field effect" biomarkers can be useful for detecting cancer adjacent to histologically negative biopsies and may be indicative of occult aggressive Pca. The multi-gene ConfirmMDx(TM) for Prostate Cancer test demonstrated that epigenetic profiling is a predictor for PCa risk, especially to identify those men who should (not) undergo a repeat biopsy following a negative initial biopsy. An integrated risk management approach that combines this epigenetic assay with other risk factors resulted in an improved prediction for the presence of PCa with sensitivity and negative predictive values of respectively 74% and 91%. 

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