Exosome Diagnostics August 2022 Newsletter

The Role of the ExoDx™ Prostate (EPI) Test in Clinical Practice: Contemporary Utilization of the EPI Test

In May of 2020, we published a Level I Evidence clinical utility study that demonstrated how the ExoDx Prostate test improved patient compliance with the biopsy recommendation and led to a 30% increase in diagnosis of high-grade prostate cancer (HGPCa). This month, urology experts Judd W. Moul, MD, and Grannum R. Sant, MD, share a “How I Use It” opinion piece in the Canadian Journal of Urology highlighting the real-world contemporary utilization of the ExoDx Prostate test in primary care and urology practices. The EPI test is one of the more frequently utilized liquid biomarkers for risk-stratification in men prior to initial and repeat (“prior negative”) prostate biopsy.

While there are many strategies in how to utilize biomarker + MRI, there is growing appreciation that the two approaches are complementary in assessing risk for high grade prostate cancer. Utilizing both MRI and EPI in tandem at his clinic, Dr. Moul typically follows a negative MRI with the EPI test and recognizes a score of greater than 20 as, "an actionable data point to trigger a recommendation for systematic biopsies." Dr. Moul echoes the importance of combining “MRI and EPI pre-biopsy testing” as they’ve “been shown to be better [together] than either alone” in his practice.

Beyond risk stratification of HGPCa, Dr. Judd Moul emphasized the significance of its utility within his practice, as it is used as a “prioritization tool for scheduling of prostate biopsy procedures.” This is due to the correlation between EPI scores and risk of HGPCa on biopsy. Simply put, “the higher the score, the higher the scheduling priority.” Using this method, Dr. Moul streamlines his practice, ensuring patients receive the right intervention at the right time for them.

With the EPI test leveraged, Dr. Moul informs his patients of their risk of HGPCa through a noninvasive, urine-based assay coupled with MRI resulting in a “high biopsy compliance rate when EPI was added to the Duke Primary Care-Duke Cancer Institute prostate cancer screening algorithm.” Though biopsies remain the gold standard in diagnosing prostate cancer, Dr. Moul strengthens his accuracy and shortens time to diagnose through a specific, sensitive combination of tools.