ExoDx® Prostate(IntelliScore) – EPI – was developed by Exosome Diagnostics, Inc. (ExoDx), and launched in 2016 as the first exosome-based diagnostic. 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 cancerEPI analyzes exosomal RNA for three biomarkers (PCA3, SPDEF and ERG) 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. EPI, 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). 


At ExoDx we are focused on developing and commercializing revolutionary, biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. Our diagnostics harness the power of exosomes, important cell messengers carried within biofluids, such as plasma, urine, cerebrospinal fluid and saliva. Exosomes contain RNA, DNA and proteins from their cell of origin. Our Chief Scientific Officer and Founding Scientist, Johan Skog, PhD, while at Massachusetts General Hospital, was the first to demonstrate that molecular mutations in a tumor could be detected in RNA extracted from exosomes and that this information could be used diagnostically. 


Building upon this landmark discovery, our proprietary exosome-based technology can harvest the rich and comprehensive molecular information contained within exosomes from any biofluid – fresh or frozen – without requiring the use of tissue. Highly robust and versatile, our technology holds the potential to deliver on the promise of personalized healthcare to guide treatment decisions precisely and in real-time along the entire patient care continuum. 

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Exosome Diagnostics and ExoDx, are registered and unregistered trademarks of Exosome Diagnostics, Inc.