Prostate ConfirmMDx regulatory update

MDxHealth said Medicare administrative contractor Palmetto GBA issued a local coverage determination (LCD) that includes limited coverage of MDxHealth's ConfirmMDx for Prostate Cancer to reduce unnecessary repeat prostate biopsies, starting Nov. 3. MDxHealth markets the epigenetic laboratory-developed test (LDT) based on DNA methylation biomarkers to assess the presence or absence of cancer cells in biopsy tissue, ruling out healthy men from undergoing unnecessary repeat biopsies (see BioCentury, July 14). ...