Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2–10 ng/mL

Abstract

Background 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. We sought to assess the impact of EPI on the decision to biopsy in a real-world clinical setting. Methods We conducted a prospective, randomized, blinded, two-armed clinical utility study that enrolled 1094 patients with 72 urologists from 24 urology practices. Patients were considered for prostate biopsy at enrollment based on standard clinical criteria. All patients had an EPI test; however, patients were randomized into EPI vs. control arms where only the EPI arm received results for their biopsy decision. Results 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. In contrast, 87% of patients with positive EPI scores were recommended to undergo biopsy with a 72% compliance rate to the urologist’s recommendation. 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). Overall, 68% of urologists reported that the EPI test influenced their biopsy decision. The primary reason not to comply with EPI results was rising PSA. Conclusion To our knowledge this is the first report on a PC biomarker utility study with a blinded control arm. The study demonstrates that the EPI test influences the overall decision to defer or proceed with a biopsy and improves patient stratification.

A urine-based Exosomal gene expression test stratifies risk of high-grade prostate Cancer in men with prior negative prostate biopsy undergoing repeat biopsy

“…men presenting for their initial biopsy with a PSA 2-10 ng/ mL where it achieved an NPV of 91%, a sensitivity of 91 and 34% specificity [16]. A recent blinded control arm utility study demonstrated that the EPI test reduced the number of biopsies when the test was negative, and helped to identify 30% more high-grade prostate cancers compared to the control arm without the EPI test result [34]. It is well established in the literature that prevalence of prostate cancer is significantly lower in a prior negative biopsy population and that this clinical feature will favorably impact test performance when included in risk assessment models (and some commercial assays) [35,36].…”

Clinical Performance of the ExoDx (EPI) Prostate Intelliscore Test to Predict High-grade Prostate Cancer at Initial Biopsy: A Pooled Analysis of Three Independent Prospective Studies.

“…All sites received a urine collection vessel and shipping kits; men from the rst validation study received a pediatric urine cup with instructions to only collect urine within the requested volume range, while a standardized 20 ml volume-restricted vessel was used in the second validation cohort and the utility study. Previous methods used in exosome isolation, extraction of RNA, and reverse transcriptase polymerase chain reaction (RT-PCR) were previously published (8)(9)(10)(11). The test result provides a binary low or high risk score based on a validated cut-point of 15.6 (scale 0-100) that predicts the presence of Grade group (GG) 2 or higher prostate cancer.…”

“…The EPI test (Exosome Diagnostics, Waltham, MA) is a rst-catch urine exosome-based liquid biopsy assay which has been independently validated in two prospective multi-site studies and the standard of care control arm of a utility study which evaluated EPI in the biopsy decision process (8)(9)(10). Utilizing the expression levels from three genes (i.e.…”

Pathogenesis of Viral Hepatitis-Induced Chronic Liver Disease: Role of Extracellular Vesicles

“…Furthermore, as EVs contain molecules that are specific to a particular organ or disease, EV-based liquid biopsy can be optimized to be highly disease-specific. Such non-invasive tests also allow for a complementary or standalone test, providing rapid diagnosis or prognosis of diseases, such as the FDA approved EV-based biomarker for prostate cancer ExoDX (Tutrone et al, 2020).…”