the epi test
The ExoDx Prostate® (IntelliScore) – EPI – is a simple, non-invasive urine test that measures three important genomic RNA bio-markers which can be used by you and your physician in discussing your need for a prostate biopsy. This test helps you and your physician in making an informed prostate biopsy decision.
This is a test designed for use in men 50 years and over with a PSA between 2–10 ng/ml who are being considered for initial biopsy.
How EPI Works
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.