Prostate cancer is a leading cause of cancer in men affecting more than 191,000 in the United States, resulting in 30,000 deaths annually. Prostate cancer diagnosis can be a frightening time for men, especially during a time when appointments and procedures have been cancelled, and COVID-19 has upended our normal way of practicing, leaving both patients and physicians scrambling for answers.

The current gold standard for prostate cancer diagnosis – needle biopsy – often lacks a true reflection of the molecular profile of the tissue given sampling error, complex tumor heterogeneity as well as 25%-50% false negative rates. Further, the relative lack of PSA specificity for prostate cancer has led to over-diagnosis of clinically insignificant prostate cancer.

There is growing demand for diagnostic tools that provide prognostic information to identify the right patient to undergo biopsy at the right time, while avoid missing high-grade prostate cancers (HGPCa). Liquid biopsy is a non-invasive method that may improve early detection of high-grade prostate cancer and therefore inform patients’ treatment selection. The ExoDx Prostate Test, or “EPI” is a validated, non-invasive urine gene expression assay that provides actionable information that aids the prostate biopsy decision for men in the PSA ‘gray zone’ of 2-10ng/mL and is not dependent on clinical factors such as PSA, and other clinical risk factors.

Recent findings from a real-world clinical study underscore how EPI supports clinical decision making and motivate sometimes unwilling patients to proceed to or defer prostate biopsy. In addition, this tool was proven to detect more high-grade prostate cancers over standard of care parameters alone.