Patient Frequently Asked Questions

Questions Related to the ExoDx Prostate Test

What is the ExoDx Prostate Test?

The ExoDx Prostate Test is a non-invasive, non-DRE, urine test used as a risk assessment tool to provide risk probabilities for aggressive prostate cancer. It relies on cancer-specific genomic biomarkers found in the urine. Patients below the cut-point of 15.6 are considered at low risk of having high-grade prostate cancer. Patients above the cut-point of 15.6 are considered to have higher risk of high-grade prostate cancer. The doctor and the patient should discuss the patients’ ExoDx Prostate score in a shared decision-making process including all relevant factors and make a decision as to whether or not to proceed with a prostate biopsy.

 

What is measured in the ExoDx Prostate Test?

The test analyzes three cancer-specific biomarkers found in the urine associated with aggressive prostate cancer: ERG, PCA and SPDEF. It purposefully does not analyze prostate specific antigen (PSA).

 

Why doesn't The ExoDx Prostate Test include the PSA in its algorithm?

Studies have demonstrated that the PSA cannot distinguish between aggressive prostate cancer and non-aggressive prostate cancer. Instead, we have tested and studied The ExoDx Prostate Test biomarkers (ERG, PCA and SPDEF) in over 1,000 clinical trial subjects to offer an independent data point that is complementary to PSA and provides you and your doctor more information to help patients like you make the right biopsy decision, at the right time.

 

Does the doctor have to perform a digital rectal exam or prostate massage to obtain the test?

No. One of the key benefits of the ExoDx Prostate Test is that it does not require you to do a digital rectal exam (DRE) prior to providing a urine sample. In fact, if you do have a DRE then you must wait 24 hours before you are able to provide a urine sample for the ExoDx Prostate Test.

 

Who should take the ExoDx Prostate Test?

The intended use population for the ExoDx Prostate Test is:

  • Age 50 or over
  • PSA of 2-10 ng/mL
  • Considering an initial biopsy

 

What is a liquid biopsy?

A liquid biopsy is a new class of non-invasive diagnostic testing that analyzes genetic material from the cell or tissue through the body fluids – such as urine, blood, or cerebrospinal fluid. A liquid biopsy can offer greater sensitivity vs. biopsy, but also avoids the pain and discomfort associated with traditional tissue biopsies, which rely on cutting a tiny piece of tissue to perform pathological analysis. Hence why liquid biopsies are also called “non-invasive”.

 

If I had sexual intercourse will it affect the results of the ExoDx Prostate Test?

There is no evidence to suggest that sexual intercourse would interfere with an ExoDx Prostate result.

 

How do I get the ExoDx Prostate Test?

The ExoDx Prostate IntelliScore must be ordered by your physician. Your physician will fill out a test requisition, collect a simple urine sample, and send the kit to our laboratory to perform the test.  Talk to your doctor or call 1-844-EXOSOME.

 

Questions Related to Prostate Cancer

What is high grade prostate cancer?

High grade prostate cancer or clinically significant prostate cancer is defined as a Gleason 7/Grade Group 2 and above. It may grow and spread quickly to other parts of the body. This is why early detection for aggressive prostate cancers is important.

 

What is a PSA?

The prostate-specific antigen or PSA is a protein released into the blood stream by the prostate gland. The PSA Test is used to measure the presence of the PSA in the blood stream and is the first step in screening for prostate cancer. However, reliance on the PSA Test alone has led to over treatment and misdiagnosis.

 

What is an elevated PSA?

There is no universally accepted rule-of-thumb as to what defines an elevated PSA. Some institutions have indicated that 2, 2.5 or 4 is the start of an elevated PSA. At Exosome Diagnostics, we provide clarity in this uncertain world by validating the ExoDx Prostate Test in men undergoing screening with PSA levels of 2 to 10 ng/mL to give them better clarity on whether they are at lower risk for aggressive prostate cancer.

Disclaimers

  • The ExoDx Prostate test does not provide a diagnosis of prostate cancer.

  • The ExoDx Prostate Test does not replace the PSA.

  • The results of the ExoDx Prostate Test should be interpreted in conjunction with other laboratory and clinical data available to the clinician when considering the prostate biopsy decision.

  • A low risk ExoDx Prostate IntelliScore result does not preclude the possibility of developing cancer in the future.

  • The results of the test cannot be interpreted as absolute evidence of the absence or presence of malignant disease.

  • A test is not a substitute for a biopsy; it is intended to support the biopsy decision.

  • Invasive treatment for benign prostatic disease within 6 months or taking medications that have an effect on serum PSA levels within 3 to 6 months were exclusions from the validation studies, and therefore any possible impact on the ExoDx Prostate Test is unknown.

  • Any possible impact of a concurrent diagnosis of prostatitis while undergoing the ExoDx Prostate Test was not specifically validated.  In the event of an active diagnosis of prostatitis, the recommendation would be to wait until the treatment course is complete before sample collection.

  • The ExoDx Prostate Test is not indicated for:

    • Men with a diagnosis of prostate cancer

    • Prior treatment of prostate cancer