ExoDx Urine Prostate Test to Evaluate Risk of Aggressive Prostate Cancer Prior to First Biopsy.

The ExoDx Prostate Test is a non-invasive, non-digital rectal exam, urine test used as a risk assessment tool to provide risk probabilities for aggressive prostate cancer.

The technology relies on cancer-specific genomic biomarkers found in the urine. The test analyzes three cancer-specific biomarkers found in the urine associated with aggressive prostate cancer: ERG, PCA and SPDEF. It purposefully does not analyze prostate specific antigen (PSA). Patients below the cut-point of 15.6 are considered at low risk of having high-grade prostate cancer. Patients above the cut-point of 15.6 are considered to have higher risk of high-grade prostate cancer.

The test is intended for men over 50 with PSA’s from 2-10 ng/mL and considering an initial biopsy. The doctor and the patient should discuss the patients’ ExoDx Prostate score in a shared decision-making process including all relevant factors and make a decision as to whether or not to proceed with a prostate biopsy.

This urine-exosome, pre-biopsy risk stratification technology is now commercialized. See the following link.