About ExoDx®Prostate(IntelliScore): This test is a non-invasive urine-based test and is used in addition to PSA and other standard of care factors (including age, race and family history) to allow physicians to predict if a patient presenting for an initial prostate biopsy does not have high grade prostate cancer, and thus could avoid the prostate biopsy. Rather, this patient can continue to be monitored.
How the test works: ExoDx Prostate(IntelliScore) analyzes exosomal RNA for three biomarkers known to be expressed in men with high-grade prostate cancer. Using an algorithm that integrates this three-gene signature, our test assigns an individualized risk score for patients that predicts the presence of high-grade (Gleason Score greater than or equal to 7) prostate cancer. This test is intended for use in men 50 years or older with a PSA 2-10ng/mL presenting for an initial biopsy. A urine sample WITHOUT a digital rectal exam (DRE) is required for this test.
What is exosomal RNA? Exosomes are messengers released by all living cells into biofluids (ex: urine). Exosomes contain RNA, DNA, and proteins. By isolating and analyzing exosomal RNA, Exosome Diagnostics’ technology platform can reveal important information about cells in the body, including specific biomarkers and mutations linked to certain cancers.
How accurate is the test? They conducted a large, well-designed, prospective clinical validation study to evaluate the test’s performance on key accuracy and sensitivity measures. In the study, the test demonstrated a high negative predictive value, or NPV, of 91.3 percent. NPV is a commonly used measure of a diagnostic’s predictive accuracy. The test was able to predict high-grade prostate cancer biopsy results with 91.9% sensitivity. “Sensitivity” (also called the true positive rate) measures the percentage of high-grade prostate cancer that the test correctly identified.