Epigenomics submits the fourth module to the FDA for Epi proColon
Epigenomics AG announced 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®.
Other news from the department business & finance

Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.