Epigenomics, the German-American cancer molecular diagnostics company, completed the enrollment for its ADMIT trial (AD herence to Minimally Invasive Testing) for Epi proColon, its non-invasive blood-based test for colorectal cancer (CRC) screening.
Epigenomics has successfully completed enrollment in the ADMIT clinical trial this week. Study subjects were identified as historically non-compliant to CRC screening according to current screening guidelines by its partners, Kaiser Permanente and Geisinger Health Systems, who actively manage CRC screening programs in the U.S.A. Subjects were invited to a clinic visit and once enrolled into the trial, were randomized to either the FIT test to take home to complete and send back within six weeks, or to a blood draw for the Epi proColon test, to be completed in the same time frame. The Company expects to announce the results from this study during the second quarter of 2015.
The trial results will be submitted to the FDA following data analysis after completion of the six week response window.
Dr. Thomas Taapken, CEO/CFO of Epigenomics, said: “We are excited that we have reached our goal of achieving this important milestone. We thank our partners Kaiser Permanente and Geisinger Health System for their strong support in the conduct of this trial and, more than ever, we look forward to having the opportunity of offering screening eligible adults in the United States an easy, non-invasive option for regular colorectal cancer screening once we receive approval from the FDA.“
Despite the unexpected delay in the U.S. regulatory process for Epi proColon, 2014 was a successful year for Epigenomics. As Thomas Taapken explained, the company obtained market approval for its innovative blood-based colorectal cancer screening assay in China, which represents a major milestone in the history of Epigenomics. Together with its partner BioChain, the company is now seeking to address this tremendous market opportunity.
In 2014, Epigenomics’ total revenue amounted to €1.5M. Compared with the previous year, there was a slight decrease (€1.6M in 2013), mainly due to the already mentioned phase out of some existing licensing agreements ahead of the expected approval of the Epi proColon test kit for commercialization in the U.S.A.
Product sales, on the other hand, fully met Epigenomics’ expectations and increased from €0.6M in 2013 to €0.8M in 2014.
Regarding the company’s outlook for 2015, throughout this year and beyond, Epigenomics will actively support its partners BioChain and U.S Polymedco in rolling out the test and making it an integral part of standardized CRC screening procedures in countries where it is approved. To this effect, securing reimbursement and heightening healthcare providers’ awareness of the product will be a key activity for the company in 2015, which will determine the commercial success.