FAQs

FAQs

The ExoDx® Prostate(IntelliScore) – EPI – is a non-invasive urine-based test designed to be used along with Prostate-Specific Antigen (PSA) levels and other Standard of Care factors (SOC); including age, race and family history. EPI risk stratifies patients presenting for initial biopsy by assessing their risk of aggressive prostate cancer. This test equips physicians with an additional data point in the prostate cancer diagnostic paradigm and aids in the shared biopsy decision making process.

EPI analyzes exosomal RNA for three biomarkers known to be expressed in men with High-Grade Prostate Cancer (HGPCa). Using a proprietary algorithm that integrates this three-gene signature, our test assigns an individualized risk score for patients that assesses the presence of HGPCa (Gleason Score ≥ 7). EPI is intended for use in men 50 years or older with a prostate-specific antigen (PSA) 2-10ng/mL presenting for an initial biopsy. Performing the test involves patients submitting a simple urine sample, without having to first undergo a digital rectal exam (DRE), that is then sent to our laboratory for analysis. 

Where a patient is 50 years of age or older and presents with an elevated PSA – within the PSA grey zone (2-10 ng/mL) – you may consider using EPI to assess the patient’s risk of HGPCa. The EPI score provides actionable insight about your patient’s risk of HGPCa, and when used in conjunction with SOC parameters it can help you to make a more informed decision about prostate biopsy.

 

The optimal patient treatment plan should be determined using the patients EPI score, in conjunction with SOC parameters and your best clinical judgement.

 

The EPI test helps you to assess your patient’s risk of HGPCa and risk-stratify men to prostate biopsy. This test can reduce the total number of biopsies that are performed on patients with low-risk, or indolent disease and helps to identify and diagnoses cancers that need to be treated.

Yes. This test was prospectively validated in two large clinical studies. The first study was conducted at 22 sites and the second at 14 clinical sites across the United States. Both studies were conducted with leading urologists and prostate cancer researchers from both academic and community-based settings.

EPI is a stand-alone molecular test, unlike other liquid biopsies for prostate cancer, EPI does not incorporate SOC parameters or PSA iso-forms in its algorithm. EPI is a true liquid biopsy entirely based on RNA. 

Exosome Diagnostics makes a concerted effort, including appeals to have health insurance providers cover the cost of the EPI test. For more information refer to our billing information, here.

If you have any additional questions, please contact your local Sales Representative, or our Billing Department on +1 (888) 336 8283 (Ext. 242 or 245).

No. The EPI test is not FDA approved. 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.

Test results are available 3-5 days after the sample is received in our laboratory. The results will be mailed to your practice via FedEx, and you will also receive a copy of the results via fax.

If you would like more information, or if you are interested in using EPI in your clinical practice please contact us at +1 (844) 396 7663, to request a visit to your office by one of our sales representatives.

No. This test can only be run in our CLIA certified laboratory.

For more information please contact Exosome Diagnostics, on +1 (844) 396 7663.

CLIA: Clinical Laboratory Improvement Amendments of 1988, established standards for laboratory testing – for more information visit: https://wwwn.cdc.gov/clia/Regulatory/default.aspx

DRE: Digital Rectal Exam

EPI: ExoDx® Prostate(IntelliScore)

ERG: ERG (ERG, ETS Transcription Factor) is a Protein Coding gene.

FDA: Food and Drug Administration

GS: Gleason Score

HGPCa: High-Grade Prostate Cancer

PCA3: Prostate Cancer Antigen 3, a gene that expresses a non-coding RNA

PSA: Prostate-Specific Antigen

SOC: Standard of Care

SPDEF: SPDEF (SAM Pointed Domain Containing ETS Transcription Factor) is a Protein Coding gene. Diseases associated with SPDEF include Prostate Cancer. 

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.