ExoDx™ Prostate IntelliScore EPI CE‑IVD
The only exosome-based test that provides unique, actionable intelligence to help you decide if biopsy is necessary; independent of PSA and other standard of care (SOC) features.
What is the EPI-CE Test?
The EPI-CE Test is a simple, non-DRE, urine-based, liquid biopsy test indicated for men 50 years of age and older with a prostate-specific antigen (PSA) 2-10ng/mL, or PSA in the “gray zone”, considering an initial biopsy. The EPI-CE test returns a risk score that determines a patient’s risk of clinically significant prostate cancer (Gleason Score ≥7) on prostate biopsy. A score above the validated cut-point of 15.6 is associated with an increased likelihood of GS≥7 PCa on a biopsy and a score below the cut-point of 15.6 is associated with a decreased likelihood of GS≥7 PCa. This test can help reassure a patient to avoid a prostate biopsy or improve patient compliance with physician recommendation.
What’s Unique about the EPI-CE Test
What's unique about The EPI-CE test is that it is an exosome-based genomic test that offers an additional data point that is not obtained through the general work up. It offers unique intelligence that is not influenced by DRE, family history, PSA, or other standard of care features.
Clinical Validity of US EPI versus EPI-CE
The clinical validity of ExoDx Prostate (EPI) test is supported by multiple peer-reviewed publications and presentations, representing approximately 5000 patients from 40 academic and community urology clinics in the US.
The EPI-CE test is based on the well-established ExoDx™ Prostate test which has successfully operated from ExoDx’s CLIA facility in the US since 2017 and is reimbursed by several leading insurance providers. Both tests share the same specimen requirements, exoRNA isolation methodology, RT-qPCR 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.
ExoDx™ Prostate IntelliScore EPI CE-IVD Validation Data
The EPI-CE test is a non-invasive urine exosomal RNA CE-IVD test for predicting high grade prostate cancer (≥GG2) in patients under suspicion of prostate cancer.
In a European IVD validation study, the EPI-CE test was validated in a multi-center study with 109 patients enrolled from 11 clinical sites in Europe and the US.
The EPI-CE test performance was comparable to previous performance data published from US studies.
Publication of the European validation study is currently pending.
*Clinical performance from the ExoDx Prostate EPI-CE (IVD) European validation study, compared to a pooled analysis of two previously published US studies:
Study 1: A Novel Urine Exosome Gene Expression Assay to Predict High-Grade Prostate Cancer at Initial Biopsy, JAMA Oncology July 2016. Authors: McKiernan J, Donovan MJ, O'Neill V, Bentink S, Noerholm, M, Belzer Skog J, Kattan MW, Partin A, Andriole G, Brown G, Wei JT, Thompson IM Jr, Carroll P.
Study 2: A Prospective Adaptive Utility Trial to Validate Performance of a Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer in Patients with Prostate-specific Antigen 2-10 ng/ml at Initial Biopsy. European Urology I September 2018. Authors: McKiernan J, Donovan MJ, Margolis E, Partin A, Carter, B, Brown G, Torkler P, Noerholm M, Skog J, Shore N, Andriole G, Thompson I, Carrol P.
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