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MDxHealth SA Announces Positive Results of DOCUMENT Clinical Validation Trial of Its ConfirmMDx for Prostate Cancer Test


Monday, 7 Oct 2013 02:00am EDT 

MDxHealth SA announced that its ConfirmMDx for Prostate Cancer test met all of the primary endpoints in the completed multicenter, blinded DOCUMENT (Detection of Cancer Using Methylated Events in Negative Tissue) clinical validation trial. Preliminary analysis of data verifies the test's high negative predictive value (NPV) for ruling out the presence of prostate cancer and is an independent predictor of risk for men being considered for repeat biopsy. The Company's ConfirmMDx for Prostate Cancer is a non-invasive test performed on the residual prostate tissues from the previous negative biopsy, providing critical epigenetic insights beyond histopathology alone, to enable more informed patient management decisions. The multicenter DOCUMENT study was conducted at five U.S. urologic centers. The study involved analyzing tissue from initial negative biopsies and comparing assay results to cancer detection in subsequent biopsies within 24 months. ConfirmMDx for Prostate Cancer was used to analyze the epigenetic profile of prostate biopsy cores from 350 men screened by PSA. 

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