ExoDx prostate test granted expanded coverage by Medicare

Medicare contractor National Government Services finalizes local coverage determination for biomarker testing related to prostate cancer to include repeat biopsies and yearly testing

Bio-Techne Corporation today announced that a newly finalized local coverage determination (LCD) from National Government Services, Inc., a Medicare Administrative Contractor, includes coverage for the ExoDx Prostate Test from Exosome Diagnostics, a Bio-Techne brand. The updated policy now covers an annual ExoDx Prostate Test for men who 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, 2023.

Prostate cancer is the most common type of cancer found in men. According to a recent report from the American Cancer Society, the incidence of prostate cancer is getting worse over the last decade. There is an increase in the number of cases diagnosed, as well as in the proportion of cases diagnosed at an advanced stage. Unfortunately, the ongoing challenge in the early detection and treatment of prostate cancer is the uncertainty about which patients do, and which patients do not need invasive biopsy procedures to look for the presence of cancer.

The noninvasive, urine-based ExoDx Prostate Test was designed to capture key 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 “gray zone” of uncertainty, the ExoDx Prostate 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 the ExoDx Prostate Test for men who already had a negative biopsy but are thought to be at high risk and are considering a repeat biopsy. According to the new policy, 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.

“We are very pleased that the ExoDx Prostate Test is now covered by Medicare for high-risk men with a prior negative biopsy that are considering a repeat biopsy. 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,” said Kim Kelderman, President of the Diagnostics and Genomics Segment at Bio-Techne.


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