Date: 2014-05-08
Type of information:
phase:
Announcement: publication of results in the Journal of Urology
Company: MDX Health (Belgium)
Product: ConfirmMDx® for Prostate Cancer
Action
mechanism: 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.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The multicenter DOCUMENT (Detection of Occult Cancer Using Methylated Events in Negative Tissue) study was conducted with 350 PSA-screened men from five major urologic centers, including Johns Hopkins University, Cleveland Clinic Foundation, Lahey Clinic, University of California Los Angeles (UCLA) and East Virginia Medical School. The study involved patients with negative index prostate biopsies and compared assay results to cancer detection in subsequent repeat biopsies within 24 months. Index and repeat biopsy tissues were subjected to blinded, centralized pathology review by Jonathan Epstein, MD, Reinhard Professor of Urologic Pathology and Director of Surgical Pathology at Johns Hopkins. The ConfirmMDx for Prostate Cancer test was used to analyze the DNA from 3,687 negative tissue cores from the index prostate biopsy for epigenetic abnormalities.
Latest
news: * On May 8, 2014, MDxHealth, a molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, announced that results from DOCUMENT, a blinded, multicenter clinical validation study, substantiate that its ConfirmMDx® for Prostate Cancer test is a significant independent predictor of the risk for cancer on repeat biopsy. The accepted manuscript describing the study results is posted on the Journal of Urology (http://www.jurology.com/article/S0022-5347(14)03341-2/abstract) website and the data will be presented by principle investigator Alan Partin, MD, PhD, Professor and Chief of Urology at the James Buchanan Brady Urological Institute at Johns Hopkins School of Medicine, at the upcoming 2014 Annual Meeting of the American Urology Association (AUA) in Orlando, Florida. The multicenter DOCUMENT (Detection of Occult Cancer Using Methylated Events in Negative Tissue) study was conducted with 350 PSA-screened men from five major urologic centers. The ConfirmMDx for Prostate Cancer test was used to analyze the DNA from 3,687 negative tissue cores from the index prostate biopsy for epigenetic abnormalities. The ConfirmMDx test proved to be the most significant, independent predictor (Odds Ratio = 2.69, p-value 0.0002) for the risk of prostate cancer in a repeat biopsy, outperforming standard clinical risk factors such as age, prostate specific antigen (PSA), digital rectal exam (DRE), and pathology in multivariate logistic regression analysis. This U.S. based blinded, multicenter validation study confirmed the results of the previously published MATLOC validation study (Stewart et al, J Urol, 2013). * On October 7, 2013, MDxHealth, a Belgian molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, has announced that its ConfirmMDx for Prostate Cancer test met all of the primary endpoints in the recently 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 a significant, independent predictor of risk for men being considered for repeat biopsy. "These findings are consistent with the results from our earlier European clinical validation study that demonstrated a NPV of 90% (95% CI, 86-94%)", said Dr. Jan Groen, CEO of MDxHealth. Results from the DOCUMENT study will be published after full analysis of the data is completed.
