Epigenomics Announces Results of Colorectal Cancer Test Adherence Trial

German diagnostics maker Epigenomics said Friday that 99.5 percent patients in a pivotal trial of its Epi proColon noninvasive, blood-based colorectal cancer test adhered to the test. That compares with 88.1 percent of patients in a fecal immunochemical test arm.

The numbers differ from a baseline adherence to standard care CRC screening of less than 25 percent. This number was derived from a passive control arm in which previously noncompliant patients were offered FIT or colonoscopy as part of their standard care, the company says.

The trial was requested by the FDA as part of Epigenomics’ premarket approval application for the test, the company said. The second part of the study will determine the number of patients who complete colonoscopy after positive results from the Epi test or FIT.  — Kellen Owings