Date: 2014-05-02
Type of information:
phase:
Announcement: publication of results in the journal American Health and Drug Benefits (2014;7(3):129-134: www.AHDBonline.com)
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:
Latest
news: *On May 20, 2014 , MDxHealth, a Belgian molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, announced that the results of the ConfirmMDx® for Prostate Cancer clinical utility study will be published in the journal American Health and Drug Benefits (2014;7(3):129-134: www.AHDBonline.com). The study demonstrated a 10-fold reduction in the repeat biopsy rate in the ConfirmMDx-negative patient cohort as compared to the reported rate of repeat biopsy under the current standard of care.
The ConfirmMDx for Prostate Cancer test has been validated in blinded multicenter studies showing superior negative predictive value over standard histopathology for cancer detection in prostate biopsies. The study was designed to evaluate the impact of a ConfirmMDx-negativetest result on the urologist\'s decision for repeat prostate biopsy. Five clinical urology practices that had ordered ConfirmMDx on a minimum of 40 patients with previous, cancer-negative biopsies over the course of the previous 18 months participated in the study. The repeat biopsy rate for all 138 men in this cohort receiving a negative ConfirmMDx result (i.e., reporting no epigenetic abnormalities) was <5%, demonstrating a 10-fold reduction from the reported rate of repeat prostate biopsy, which is greater than 40% (Pinsky et al, BJUI 2007). Repeat biopsies were performed on 6 of the 138 ConfirmMDx-negative patients (4.35%), and importantly no evidence of prostate cancer was found in those men.
