Is the EPI-CE test right for you?
The EPI-CE test is for men aged 50 and above who have PSA 2-10 ng/mL (Gray Zone) measured from a recent blood test and are considering an initial biopsy.
It is a simple urine test that is designed to help you and your doctor understand more about your personalised risk of prostate cancer. It is a test that can be taken prior to an MRI and prostate biopsy. Making a biopsy decision is an important consideration between you and your doctor as there can sometimes be physical complications. This test can help determine the need to proceed.
You can get this test through your private clinician or wellness services provider. Mandatory pre and post-test consultations will be required through your clinician before you can access this test.
Take a look at our patient leaflet here for more
For Healthcare Providers and Employers:
Call us on +44 (0) 1270 623 179
or email
wellness@everythinggenticltd.co.uk
You must be 18+ to order this test
- Why?►Close tab
Helping you make decisions
When there is uncertainty about proceeding with a prostate biopsy or even an MRI, the EPI-CE test may be a solution. Clinical studies show the EPI-CE test can potentially help avoid 34% of unnecessary biopsies.
- How?►Close tab
How does it work ?
Exosomal RNA is extracted from a urine sample which provides a gene signature – ERG; PCA3; SPDEF, RT-qPCR resultant in an epi-score. The sample needs to be from the first flow of urine, in other words from the first 15mLs, as this is mostly from the prostate. A collection device is provided to ensure the sample is correct. Samples should not be done straight after a digital rectal examination (DRE) as this can affect the results.
- Process►Close tab
You can access the test through a private healthcare provider
Step 1: Talk to your clinician
Visit a private healthcare or wellness services provider and to talk to your clinician about getting the test. If they are not already an Everything Genetic sales partner, they can set up an account with us and order the test kit on your behalf.
Step 2: Sample collection
Your clinician will invite you into clinic to collect sample. Your sample will be collected and sent by them to the laboratory.
Step 3: Analysis and reporting
Your sample will be analysed in our laboratory and results will be sent directly to your clinician. The results will be provided within 10 working days of receipt at the lab. Once your clinician has your results, they will arrange to discuss the results directly with you and treatment planning options if necessary.
- Results►Close tab
Results
The EPI-CE score ranges from 0–100. If your score is above 15.6, there is a higher risk for clinically significant prostate cancer that needs further consideration, such as a prostate biopsy. Your clinician will be able to discuss your results and their implications for you.
Results are provided within 10 working days of confirmed receipt of the sample by our UK lab.- Clinicians►Close tab
The EPI-CE Test is a simple, non-invasive urine test that can help determine if your patient needs an MRI or a prostate biopsy.
It is based on the well-established ExoDx™ Prostate Test that has successfully operated from ExoDx’s CLIA facility in the U.S. since 2016. Both tests share the same specimen requirements, exoRNA isolation methodology, RTqPCR detection of biomarkers and algorithm for risk score calculation.
The EPI-CE test has been further developed for distribution and use in third-party clinical laboratories in the EU and comprises a ready to-use CE-IVD assay reagent kit and cloud-based CE-IVD software to facilitate risk score calculation. It was developed as a rule-out test 89% negative predictive value (NPV) and 92% sensitivity in the initial biopsy cohort) compared to the U.S. ExoDx Prostate Test with a negative predictive value (NPV) of 91.3% of 92% sensitivity.
Results are provided within 10 working days of confirmed receipt of the sample by our UK lab.
Take a look at our leaflet here for more information
How to access this test for your patients
We currently only offer this service to patients through private medical clinics and wellness service providers.
If you already have an account set-up with Everything Genetic, you can order the test kit online by logging into your online account. Order Now
If you don’t have an account set-up and would like to order a test kit on behalf of a patient, contact our sales team today to discuss your requirements.
Contact Us- Validation►Close tab
1. Ferlay, J et al. Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015.
2. Van Poppel, H et al. Early Detection of Prostate Cancer in 2020 and Beyond: Facts and Recommendations for the European Union and the European Commission.
European Association of Urology 2021.3. USPSTF Final Recommendation Statement Prostate Cancer Screening: www.uspreventiveservicestaskforce.org, 2018.
4. McKiernan J, Donovan M, et al. A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy. JAMA Oncology, July 2016.
5. McKiernan J., and Donovan, M. et al., A Prospective Adaptive Utility Trial to Validate Performance of a Novel Urine Exosome Gene Expression Assay to Predict Exosome Gene High-grade Prostate Cancer in Patients with Prostate-specific antigen 2-10ng/ml at Initial Biopsy, Eur Urol, 2018.
6. Haese A. et al. Multicenter Optimization and Validation of a 2-Gene mRNA urine test for Detection of Clinically Significant Prostate Cancer before Initial Prostate Biopsy.
J Urol. 2019.7. Progensa PCA3 Assay Instructions for Use Rev002; https://www.hologic.com/sites/default/files/2018-11/502083-IFU-PI_002_01.pdf.
This test is provided by:
