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Epigenomics' FDA Application for Cancer Test to Get FDA Priority Review

NEW YORK (GenomeWeb News) – Epigenomics today said that the US Food and Drug Administration has accepted its premarket approval application for its colorectal cancer test and has granted the application priority review status.

The Berlin, Germany-based firm filed the PMA for its Epi proColon test in December, after successfully completing a head-to-head comparative study with fecal immunochemical test screening. The submission was the fourth and final module of the PMA.

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

Epigenomics previously licensed the Septin9 marker to Quest Diagnostics, which has incorporated it into its ColoVantage test.

"After the encouraging results from our final clinical trial and the completion of our PMA submission late last year, we are very pleased that the agency has filed the application and has granted the priority review status to the application," Thomas Taapken, CFO and acting CEO of Epigenomics, said in a statement. "While we await the final decision from the regulators, we continue to actively plan for commercialization."

The firm recently raised almost €5 million ($6.7 million) through a rights issue and a subsequent private placement.

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