Bio-Techne said Friday that an updated local coverage determination (LCD) from National Government Services, a Medicare Administrative Contractor (MAC), includes coverage for the firm’s urine-based ExoDx Prostate Test.
The updated policy covers an annual ExoDx Prostate Test for men who have already had a negative biopsy but are thought to be at high risk for prostate cancer and are considering a repeat biopsy. The coverage will go into effect March 1.
“This important coverage determination ensures that more patients will have access to noninvasive testing before moving forward with painful, risky, and potentially unnecessary biopsy procedures," Kim Kelderman, president of the diagnostics and genomics segment at Bio-Techne, said in a statement.
The ExoDx Prostate Test, a urine-based molecular assay, was developed by Bio-Techne’s Exosome Diagnostics business. It captures molecular information to identify which men should undergo biopsies and which can safely be monitored with less-invasive techniques. For patients whose prostate specific antigen (PSA) biomarker falls into a zone of uncertainty, the test offers critical information to distinguish between patients at risk of low-grade prostate cancer and those at risk of high-grade prostate cancer.
In the new local coverage determination, National Government Services included the ExoDx Prostate Test prior to a biopsy procedure for patients age 50 or older with a PSA higher than 4 ng/mL. It also covers use of the ExoDx Prostate Test for men who have already had a negative biopsy but are thought to be at high risk and are considering a repeat biopsy.
Bio-Techne said that the updates were based on recent changes to recommendations from the National Comprehensive Cancer Network (NCCN), which now includes the ExoDx Prostate Test on the list of tests that should be considered for patients thought to be at higher risk for aggressive prostate cancer despite previous negative biopsy results.