Epigenomics AG has announced that first patients have been enrolled into its ADMIT trial (ADherence to Minimally Invasive Testing) for its noninvasive blood-based test for colorectal cancer (CRC) screening, Epi proColon.
The trial, which was requested by the FDA in the context of Epigenomics' pre-market approval (PMA) application for Epi proColon, will be conducted in 420 patients that have been historically non-compliant to CRC screening according to current screening guidelines. Epigenomics has partnered with two major US health care systems, Kaiser Permanente and Geisinger Clinic, who actively manage CRC screening programmes and who will identify the appropriate patients for the study within their managed patient populations. The trial aims to demonstrate that blood-based testing with Epi proColon will increase compliance in CRC screening as compared to FIT stool-based testing.
Patients will be invited to a clinic visit and once enrolled into the trial, they will be randomized to either the FIT test to take home to complete and send back or to a blood draw for completion of the Epi proColon test. The primary endpoint aims to show a statistically significant increase in CRC screening participation by the patients in the trial as measured by the completion rate of either test.
The study's secondary objectives will comprise a measurement of compliance to colonoscopy in those patients with positive test results with Epi proColon or FIT. Based on initial estimates, the company expects the trial to be enrolled within a few months.
"We are delighted to announce that we have started this trial hand in hand with two strong partners." stated Thomas Taapken, CEO of Epigenomics. "Kaiser Permanente and Geisinger have access to our ideal patient populations and will help to expedite this very important step in Epi proColon's path to approval. Colorectal cancer can be successfully treated if found early, and we believe the introduction of Epi proColon will be crucial in reaching the 35 million eligible Americans that have not yet been screened."
