#INTELLISCORE REVIEWS PC#

The study demonstrates that the EPI test influences the overall decision to defer or proceed with a biopsy and improves patient stratification.

#INTELLISCORE REVIEWS PC#

To our knowledge this is the first report on a PC biomarker utility study with a blinded control arm. The primary reason not to comply with EPI results was rising PSA. Overall, 68% of urologists reported that the EPI test influenced their biopsy decision. This led to detection of 30% more HGPC compared to the control arm, and we estimate that 49% fewer HGPC were missed due to deferrals compared to standard of care (SOC). In contrast, 87% of patients with positive EPI scores were recommended to undergo biopsy with a 72% compliance rate to the urologist’s recommendation. In the EPI arm (N = 458), 93 patients received negative EPI scores of which 63% were recommended to defer biopsy by the urologist and 74% ultimately deferred. control arms where only the EPI arm received results for their biopsy decision. All patients had an EPI test however, patients were randomized into EPI vs. Patients were considered for prostate biopsy at enrollment based on standard clinical criteria. We conducted a prospective, randomized, blinded, two-armed clinical utility study that enrolled 1094 patients with 72 urologists from 24 urology practices. We sought to assess the impact of EPI on the decision to biopsy in a real-world clinical setting. The ExoDx Prostate(IntelliScore) (EPI) test is a non-invasive risk assessment tool for detection of high-grade prostate cancer (HGPC) that informs whether to proceed with prostate biopsy.

Intelliscore reviews