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Confirmation for ConfirmMDx
IRVINE, Calif. & HERSTAL, Belgium—MDxHealth SA announced in May the publication of multicenter validation data demonstrating that ConfirmMDx for Prostate Cancer can aid in the identification of men with clinically significant prostate cancer in the journal The Prostate.
This study, entitled “Risk Score Predicts High-Grade Prostate Cancer in DNA-Methylation Positive, Histopathologically Negative Biopsies,” demonstrated the ConfirmMDx test’s ability to improve the identification of men with aggressive cancer, following from research on previous cohorts. Results from two previously studied cohorts, on 803 men from eight clinical centers (three in the European Union and five in the United States), were used to develop a methylation intensity algorithm and combined with the standard clinical risk factors (i.e. age, prostate-specific antigen (PSA) level, digital rectal exam and histopathological findings) to predict the outcome of the repeat biopsy.
The data indicated that the ConfirmMDx risk score was a significantly better predictor for the presence of aggressive prostate cancer compared to PSA and the Prostate Cancer Prevention Trial Risk Calculator. A ConfirmMDx-negative result yielded a negative predictive value of 96 percent for high-grade cancer and 90 percent for all prostate cancer.
According to MDxHealth, the study results “support use of ConfirmMDx to improve patient risk stratification, helping physicians to more accurately identify and focus on those men at highest risk for aggressive cancer who will benefit from repeat biopsy, improving early detection and allowing treatment at the earliest possible stage.” For men with DNA methylation-negative results, the test could aid in the reduction of over-diagnosis and treatment of patients with no or indolent disease, the company noted.
“This multicenter validation study shows that ConfirmMDx can help urologists identify men at high risk for aggressive prostate cancer who would benefit most from a repeat biopsy,” reported Dr. Wim van Criekinge, chief scientific officer of MDxHealth. “The very high NPV of 96 percent exhibited by ConfirmMDx can generate a significant reduction in unnecessary repeat biopsies.”
In other recent news of the test, MDxHealth announced June 21 that it had entered into an agreement with Duke University Health System regarding the use of its ConfirmMDx for Prostate Cancer test.
“It is critical that well-validated tests, especially those included in the NCCN Guidelines for the early detection of prostate cancer, are available to patients,” stated Dr. Judd W. Moul, the James H. Semans Professor of Surgery at Duke University Medical Center. “This test is designed to identify low-risk men who may forego an unnecessary repeat biopsy procedure, but as importantly, the test may help identify men who are at increased risk for high-grade prostate cancer, meriting repeat biopsy and early intervention.”
“Duke Urology is consistently ranked among the top ten hospital urology programs by US News & World Report, and we are pleased to support the care of their patients with our ConfirmMDx test,” stated Dr. Jan Groen, CEO of MDxHealth. “Notably, ConfirmMDx is now available to patients at eight of the top 10 hospital urology programs in the U.S.”