Margolis E, Brown G, Partin A, et al. - ExoDx Prostate (IntelliScore) (EPI) is a urine exosome–RNA assay that is noninvasive and easy-to-use, and it has been validated in 3 independent prospective multicenter clinical trials including 1,212 patients. The test can tell the difference between high-grade (≥ GG2) cancer and low-grade (GG1) cancer and benign disease. Independent of PSA and other standard-of-care variables, EPI successfully leads the biopsy decision-making process.

• The combined cohort (n = 1,212) of initial-biopsy individuals had a median age of 63 years and a median PSA of 5.2 ng/mL.

• The EPI AUC (0.70) outperformed PSA (0.56), Prostate Cancer Prevention Trial Risk Calculator (PCPT-RC) (0.62), and The European Randomized Study of Screening for Prostate Cancer (0.59) in distinguishing GG2 from GG1 and benign histology.

• With an NPV of 90%, the validated cutoff of 15.6 would avoid 23% of all prostate biopsies and 30% of “unnecessary” (benign or Gleason 6/GG1) biopsies.