The decision, issued by Medicare Administrative Contractor Palmetto GBA, is effective Dec. 10 and provides coverage of the test for about 25,000 Medicare patients.
DiaCarta scientists will partner with the University of Florida Health Cancer Center to analyze blood samples from up to 500 cancer patients undergoing radiotherapy.
The 72-SNP score is for men of European ancestry who don't have mutations in high penetrance risk genes or mutations in genes associated with aggressive disease.
The firm is preparing to launch a clinical trial for the AdxBladder test in the US early in 2019 and use the results to apply for 510(k) clearance with the FDA.
