Berlin, Germany, and Seattle, WA, U.S.A., January 7, 2013 - Epigenomics AG (Frankfurt Prime
Standard: ECX), the German-American cancer molecular diagnostics company, announced today
that it has submitted the fourth and final module of its Premarket Approval (PMA) to the United
States Food & Drug Administration (FDA) for its blood-based Epi proColon® test for the
detection of colorectal cancer in December 2012 as previously indicated, thereby completing its
submission to the FDA.
The fourth module of the PMA contained the clinical data generated with the test, including the
results of the recently reported head-to-head comparative study of Epi proColon®
to FIT, previously announced data from a clinical validation study in a cohort of prospectively collected
samples and other clinical study results generated during the development of Epi proColon®.
Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of Epigenomics
commented: "The non-inferiority of Septin9 to FIT demonstrated by the results of the head-to-
head comparative study that were announced in December 2012 was a very important milestone
for us. We are very pleased that we were able to complete the submission of the PMA to the FDA
by year end 2012, meeting our previously announced guidance. We continue to believe that our
test is as effective as other non-invasive tests currently used with the added convenience of being
a blood test, which will help drive screening compliance and therefore save more lives."
Contact Epigenomics AG
Manager IR | PR
Tel +49 (0) 30 24345 368