And hopefully so will ConfirmMDx be eventually
Reduced Rate of Repeated Prostate Biopsies Observed in ConfirmMDx Clinical Utility Field Study, AM HEALTH DRUG BENEFITS (Volume 7, Issue 3, 129-34, 2014), Wonjo et al reported on the real-world use of the ConfirmMDx assay, demonstrating the test impacts physician behavior. A total of 5 clinical urology practices that had ordered a minimum of 40 ConfirmMDx tests for patients with previous, cancer-negative biopsies over the course of 18 months participated in the study. A total of 138 patients who were considered at risk for malignancy based on traditional risk factors, but had ConfirmMDx negative test results, were identified and all were included in the analysis. A very low rate of repeat biopsies (4.4%) was observed in the ConfirmMDx negative men, as compared to the 43% rate of repeat biopsy reported in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, a large population-based randomized trial designed and sponsored by the National Cancer Institute. Repeat biopsies had been performed in 6 of the 138 (4.3%) men with a negative assay result, in whom no evidence of cancer was found on histopathology. These positive clinical utility results, which demonstrated a 10-fold reduction in the rate of repeat biopsy as compared to the reported standard of care, served as the basis for ConfirmMDx’s Medicare coverage.
PASCUAL Study is a 600 patient randomized, controlled prospective study to track the clinical utility of the ConfirmMDx assay in U.S. urologic practices for the management of patients with a previous histopathologically cancer-negative biopsy, but clinical risk factors suggesting the need for a repeat biopsy. The study, initiated in H2 2014, will compare the rate of repeat biopsies under the standard of care to the rate of repeat biopsies in patients managed with ConfirmMDx test results and is expected to demonstrate a similar low rate of repeat biopsy in the ConfirmMDx arm as reported by Wojno et al. The PASCUAL study, led by Principal Investigator Neal D. Shore, MD, FACS, CPI who serves as Medical Director for the Carolina Urologic Research Center, is expected to be completed in H1 2017.