ExoDx™ Prostate IntelliScore EPI CE-IVD

ExoDx™ Prostate EPI-CE Intended Use IVD

The EPI-CE test is a non-invasive test assessing the risk for high grade prostate cancer in men of 50 years or older, presenting for initial biopsy with a PSA level of 2-10 ng/mL and not screened by MRI, by an algorithm-based transformation of quantitative in vitro measurements of RNA biomarker levels from first catch urine samples into a prostate cancer risk score (EPI-CE Score). 

The test is not intended to substitute for prostate biopsy or diagnosis of prostate cancer, but as an aid for clinicians in the joint decision-making process with a patient of whether to proceed with biopsy. 

The product is intended to be used by professional users only.

How to order the ExoDx™ Prostate EPI-CE Test?

If you are a patient

The EPI-CE test can only be ordered by your doctor and the urine sample will be sent to Exosome Diagnostics or one of our partner laboratories for processing. Your doctor can learn about local laboratories or request an EPI sample collection kit as described below. The test result will be sent to your doctor, who will contact you when the result is available.

If you are a physician

You can learn about local laboratories offering the EPI-CE test or request an EPI sample collection kit by contacting Exosome Diagnostics with details of your name, clinic, contact information and mailing address. The collection kit contains instructions on sample donation and return shipping. The test result will be sent to the physician/clinic when the result is available.

If you are a laboratory

The EPI-CE test is intended to be used by professional users in third party clinical laboratories competent in standard molecular biology techniques and methods. For more information about performing the EPI-CE test in your own clinical laboratory, please contact Exosome Diagnostics.