What is the ExoDx Prostate Test?

The ExoDx Prostate (IntelliScore) is a test to assess your risk of having clinically significant high-grade prostate cancer (defined as Gleason 7 or higher). The ExoDx Prostate Test is a simple non-invasive, urine test that does not require a digital rectal exam (DRE). The ExoDx test provides an individualized risk score for the presence of high-grade prostate cancer (HGPCa) in men considering a prostate biopsy.

 
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Challenge of Prostate Cancer

Are You:

  • A man aged 50 or older? 
  • Have a prostate-specific antigen (PSA) level between 2 and 10 ng/mL?  
  • Speaking with your health care provider about a prostate biopsy? 

If yes, The ExoDx Prostate Test may be right for you. 

What are the benefits of the ExoDx Prostate Test?

The ExoDx Prostate Test provides a risk assessment for finding clinically significant prostate cancer that otherwise relies on biopsy in men with an elevated PSA. Right now, there just isn’t great information that can help doctors and patients screen for and diagnose prostate cancer without the over-reliance on prostate biopsies. The EPI Test provides a painless, easy to interpret, personalized and dependable answer on whether a patient has lower risk for having aggressive prostate cancer. If your test result indicates that you are at “lower risk”, then you and your doctor (using all other clinical information including family history, prior PSA, abnormal DRE) may decide not to proceed with a prostate biopsy – avoiding the pain, complications and costs associated with a prostate biopsy.

Confidence and Peace of Mind

The ExoDx Prostate Test rules out clinically significant high-grade prostate cancer, potentially avoiding a prostate biopsy.  

  • No digital rectal exam (DRE) or a prostate massage needed 
  • Simple urine collection, can occur at any time of day 
  • Offers a risk score that informs you of the risk for having high-grade prostate cancer  
  • Clinically proven in men age 50 or over, with PSA levels 2-10ng/mL, and considering a prostate biopsy 
  • Included in the 2019 National Comprehensive Cancer Center Network Guidelines (NCCN)
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Patient Assistance Program

**The ExoDx Prostate test is a simple urine test that provides actionable intelligence on biopsy decision. No digital rectal exam is required. **

The EPI Test works by analyzing prostate cancer-specific genomic biomarkers that are highly expressed during tumor cell growth found in the urine. These biomarkers are measured in a clinical laboratory and a validated algorithm calculates a score to determine a man’s risk of having aggressive or clinically significant prostate cancer.

If your ExoDx IntelliScore is: The Result Means This: The intervention is this:
< 15.6 Low risk or benign Potentially avoid biopsy
Continued monitoring
> 15.6 Higher risk Proceed to biopsy

 

Should I Get The ExoDx Prostate Test?

If you are a man over the age of 50 with a prostate specific antigen (PSA) of 2- 10 ng/mL and are considering a prostate biopsy, then you should talk to your doctor or health care provider about The ExoDx ProstateTest. 

The ExoDx Prostate Test will tell you if you are at risk for having high-grade prostate cancer. You and your doctor, together, can use this information to make an informed and shared decision on whether or not to proceed with a biopsy. 

The ExoDx Prostate Test: 

  • Included in the May 2019 NCCN guidelines 
  • Granted Breakthrough Designation by the FDA 
  • Covered by Medicare 
  • Performed in more than 30,000 men 
  • Proven to avoid almost 30% of biopsies 

Common Reasons for a Prostate Biopsy

A prostate biopsy is used to diagnose prostate cancer. Your doctor may recommend a prostate biopsy if any of these are present: 

  • Family history of prostate cancer 
  • Elevated or high PSA 
  • Increasing PSA over time 
  • Abnormal results from a digital rectal exam (DRE) 

Know Before You Go

There is a special collection cup for The ExoDx Prostate Test. Before you provide a urine sample in the doctor’s office, the professional staff will provide instructions for using the specimen collection device. It is important to correctly follow the instructions to ensure that the test sample is not rejected.

Here is a downloadable one-pager to take with you to your doctor’s office:

  1. How is prostate cancer detected?
  2. What is my PSA level and history of PSA levels?
  3. How accurate is the PSA in assessing my risk for high-grade prostate cancer?
  4. What is the chance of having a negative or undetermined result for prostate cancer if I have a prostate biopsy?
  5. What is the chance of having a positive result for prostate cancer if I have a prostate biopsy?
  6. What is the treatment plan if my prostate biopsy results in a “Low Grade” prostate cancer (Grade Group 1 or below)
  7. What are alternatives to a prostate biopsy for diagnosis of prostate cancer?
  8. Is there any risk to obtaining The ExoDx Prostate Test before the biopsy?
  9. Am I a candidate for the ExoDx Prostate Test?

Is the ExoDx Prostate Test Right for Me?

Download this document for your physician visit

1 Clinical Utility Study, 2019. Manuscript submitted.