Epi proColon® for Colorectal Cancer Screening: A Profile of Its Use in the USA

<p><b>Compliance with Ethical Standards</b></p> <p><b>Funding</b> The preparation of this review was not supported by any external funding.</p> <b>Conflicts of interest<i> </i></b>Matt Shirley is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.<br><div><br></div><div>Additional information about this Adis Diagnostic Q&A article can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews"><b>here</b></a>.<br></div><div><br></div><div><b>Abstract</b></div><div>Epi proColon^® is a blood-based colorectal cancer (CRC) screening test that presents a convenient, non-invasive option for CRC screening in average-risk adults aged ≥ 50 years who are otherwise non-compliant to guideline-recommended screening programs. The Epi proColon test involves the use of a real-time PCR assay to detect methylated <i>Sept9</i> DNA (a biomarker for CRC) in plasma derived from a whole blood sample. Epi proColon generally performed well in prospective clinical trials, having non-inferior sensitivity for detecting CRC compared with a fecal immunochemical test (FIT). Microsimulation modeling supports annual Epi proColon testing, as for FIT. Although the Epi proColon test specificity is lower than that of a FIT, the Epi proColon test may be useful for improving participation and compliance in CRC screening, as evidenced in a small randomized controlled clinical trial which showed that uptake of an offer of an Epi proColon blood test was significantly higher than that for a FIT in subjects who were overdue for CRC screening.<br></div><div><p>© Springer Nature Switzerland AG 2020</p><br></div>