the epi test
ExoDx® Prostate(IntelliScore) – EPI – 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). EPI can be employed in the shared decision-making process between physicians and patients to guide the prostate biopsy decision. In stratifying the risk of high-grade prostate cancer, this test potentially avoids an initial biopsy in men with negative and/or indolent prostate cancer.
EPI analyzes exosomal RNA for three genomic biomarkers that are expressed in men with high-grade prostate cancer. Using a proprietary algorithm that integrates this three-gene RNA signature, the EPI test assigns an individualized risk score for the presence of high-grade (Gleason Score ≥ 7) prostate cancer.
ExoDx® Prostate(IntelliScore) – EPI – is intended for use in men 50 years or older with a prostate-specific antigen (PSA) 2-10ng/mL (“Grey Zone”) presenting for an initial biopsy and involves patients submitting a simple urine sample, without having to first undergo a digital rectal exam (DRE).
In two large prospective clinical validation studies, EPI demonstrated a statistically significant improvement in the ability to accurately distinguish high-grade prostate cancer in men presenting for an initial biopsy when added to the standard of care, versus standard of care alone.1,2 The first study was conducted at 22 and the second at 14 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.
A Stand-Alone Molecular Test
The EPI test is the only prostate cancer bio-marker, related to the prostate biopsy decision, that does not reincorporate PSA or Standard of Care (SOC) parameters into the algorithm.
Seamless Clinical Integration
The EPI test can be seamlessly integrated into your clinical office workflow. The simple, non-invasive urine sample can be collected at any time of the day and does not require a DRE before collection. Once the sample has been collected and received in our laboratory, the results are returned to your practice within 3-5 days so that you can share the results with your patient as part of the shared decision making for the biopsy decision.
1 McKiernan, et al. JAMA Oncology 2016. 2 McKiernan et al. Journal of Urology [abstract] 2018.
This test was evaluated and its performance characteristics determined by Exosome Diagnostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Exosome Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) Act of 1988 as qualified to perform high complexity clinical testing. CLIA number – 22D2093470
Exosome Diagnostics and ExoDx, are registered and unregistered trademarks of Exosome Diagnostics, Inc.