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Epigenomics Completes Submission of CRC Test to FDA

NEW YORK (GenomeWeb News) – Epigenomics said today that it has completed the submission of its blood-based test for the detection of colorectal cancer for premarket approval by the US Food and Drug Administration.

The submission of the fourth and final module of its Epi proColon test last month included the results of a comparative, head-to-head study between this test and fecal immunochemical test screening, clinical validation study data, and other clinical study results that were generated during the test's development.

An Epigenomics test, based on the Septin9 protein, has been available as a CE-marked test kit in Europe and the Middle East since 2009, and, in 2011, it launched an improved version, the Epi proColon 2.0 CE.

"The non-inferiority of Septin9 to FIT demonstrated by the results of the head-to-head comparative study that were announced in Dec. 2012 was a very important milestone for us," Epigenomics' Acting CEO and CFO Thomas Taapken said in a statement.

"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," Taapken added.