FDA approves Epigenomics’ Epi proColon test
http://www.biocentury.com/dailynews/company/2016-04-13/fda-approves-epigenomics-epi-procolon-test
Published on Wednesday, April 13, 2016
Epigenomics AG (Xetra:ECX) said FDA approved a PMA for its Epi proColon blood-based colorectal cancer (CRC) screening test. Epigenomics and Polymedco Inc. (Cortlandt Manor, N.Y.) will jointly market Epi proColon in the U.S.
Epigenomics spokesperson Peter Vogt said the partners expect to launch the test in the next few weeks, but did not disclose the list price.
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In November, Epigenomics appealed FDA’s request for additional data demonstrating that Epi proColon would increase compliance in patients with a history of non-compliance to recommended CRC screening programs. The request came in a response letter for Epigenomics’ PMA, the second it had received for Epi proColon.
Epi proColon detects methylated DNA of the septin 9 (SEPT9) gene in blood plasma by real-time PCR.
Epigenomics gained EUR 1.31 (25%) to EUR 6.58 on Wednesday.
Exact Sciences Corp. (NASDAQ:EXAS), which markets CRC screening test Cologuard, rose $0.34 to $7.46 on Wednesday. Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene.