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FDA Seeks More Data Before Decision on Epigenomics' Colorectal Cancer Test

NEW YORK (GenomeWeb) – Epigenomics today announced that the US Food and Drug Administration has requested further data before making a decision on whether to approve the firm's blood-based colorectal cancer screening test.

Epigenomics has received a response letter from the FDA providing guidance and recommendations for improving the pre-market approval application for the German molecular diagnostics firm's Epi proColon screening test. The FDA requested additional data showing that the test will increase compliance to colorectal cancer screening in the intended use population.

"While disappointed by the FDA's decision, we will make every effort to address the outstanding questions as soon as possible," Epigenomics CEO and CFO Thomas Taapken said in a statement. "We remain highly committed to providing an innovative and convenient option to those many Americans who do not undergo colorectal cancer screening."

The firm said in a statement that its management is taking immediate steps to address the issue, including meeting with the FDA, and that it expects it will need an additional study to demonstrate increased compliance.

Last year, the FDA told Epigenomics that the Epi proColon test was not approvable. The test has already been approved by the China FDA.

Epigenomics has also adjusted its outlook for fiscal year 2015. The firm said it expects revenues to exceed last year's revenues of €1.5 million ($1.6 million), but fall significantly short of the projected €3 million to €4 million.

Shares of Epigenomics were down almost 3 percent at €5.14 at the close of trading on the Frankfurt Stock Exchange.

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