Date: 2016-05-09
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the journal The Prostate
Company: MDxHealth (Belgium)
Product: ConfirmMDx® for Prostate Cancer
Action
mechanism: diagnostic test. ConfirmMDx® for Prostate Cancer is the first epigenetic, and only tissue-based test in the 2016 NCCN Guidelines for early detection of prostate cancer which addresses false negative biopsy concerns. This molecular diagnostic test provides a high negative predictive value (NPV) of 96% for clinically significant prostate cancers, and 90% NPV for all prostate cancers, as well as prostate mapping of the test results to help guide repeat biopsies.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology - Diagnostic
Country:
Trial details:
Latest
news: * On May 9, 2016, MDxHealth announced the publication of multicenter validation data demonstrating that ConfirmMDx® for Prostate Cancer can aid in the identification of men with clinically significant prostate cancer (PCa) in the journal The Prostate. This study entitled "Risk Score Predicts High-Grade Prostate Cancer in DNA-Methylation Positive, Histopathologically Negative Biopsies" demonstrates the ConfirmMDx test's ability to improve the identification of men with aggressive cancer. Results from two previously studied cohorts, on 803 men from 8 clinical centers (3 in the EU and 5 in the US), were used to develop a methylation intensity algorithm, and combined with the standard clinical risk factors, i.e. age, PSA, DRE and histopathological findings, to predict the outcome of the repeat biopsy. With an AUC of 0.76, the ConfirmMDx risk score was a significantly better predictor for the presence of aggressive prostate cancer compared to PSA (p = 0.004) and the Prostate Cancer Prevention Trial Risk Calculator (p = 0.029). A ConfirmMDx-negative result yielded a Negative Predictive Value of 96% for high-grade cancer, and 90% for all prostate cancer.
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 aids in the reduction of over-diagnosis and treatment of patients with no or indolent disease, which is consistent with the NCCN guidelines.
