ExoDx®Prostate(IntelliScore) is a non-invasive urine-based test designed to be used along with PSA and other standard of care factors (including age, race and family history) to enable physicians to predict whether a patient presenting for an initial biopsy does not have high-grade prostate cancer and, thus, could potentially avoid an initial biopsy and, instead, continue to be monitored. ExoDx Prostate(IntelliScore) analyzes exosomal RNA for three biomarkers known to be expressed in men with high-grade prostate cancer. Using a proprietary 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 ≥ 7) prostate cancer. ExoDx Prostate(IntelliScore), which is intended for use in men 50 years or older with a prostate-specific antigen (PSA) 2-10ng/mL presenting for an initial biopsy, involves patients submitting a simple urine sample, without having to first undergo a digital rectal exam (DRE).
ExoDx® Prostate(IntelliScore) is now available for clinical use as a Laboratory Developed Test (LDT) in the United States. Exosome Diagnostics plans to conduct additional studies, including outcomes and economic studies, for ExoDx Prostate(IntelliScore). The company is also planning for European IVD-CE marking (European In Vitro Diagnostic Approval), as well as for clearance or approval of an In Vitro Diagnostic (IVD) version of the test with the U.S. Food and Drug Administration (FDA).
- Non-invasive: Uses first-catch urine sample; no DRE exam required
- Actionable: Provides a single score that is easy to read and use
- Clinically validated: Robust accuracy and sensitivity demonstrated in large, well-designed, multi-center study
- Genetically based: Analyzes three biomarkers on exosomal RNA that are indicative of cancer aggressiveness
- Test performed in a CLIA-certified lab
In a large clinical validation study, ExoDx Prostate(IntelliScore) demonstrated a statistically significant improvement in the ability to accurately predict high-grade prostate cancer in men presenting for an initial biopsy when added to the standard of care versus standard of care alone (McKiernan et al, 2015). The study was conducted at 22 clinical sites across the United States and involved some of the country’s leading urologists and prostate cancer researchers from both academic and community-based settings.
The data were presented in a 2015 American Urological Association Annual Meeting plenary late-breaking abstract presentation. View the webcast.