Epigenomics AG ADR (EPGNY)

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FDA Panel to Meet About Epigenomics' PMA for Colorectal Cancer Test

November 27, 2013

By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) – A US Food and Drug Administration panel is tentatively set to meet in four months to discuss Epigenomics’ colorectal cancer screening test, the company said today.

FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on March 25, 2014 over Epigenomics’ premarket approval submission for its Epi proColon test. The company completed its submission in January, and in February, FDA granted Epigenomics’ application priority review status.

Earlier this month, the company announced flat revenues for its third quarter.

Related Stories Epigenomics' Preliminary 2013 Revenues Improve 60 Percent February 26, 2014 / GenomeWeb Daily News

Epigenomics, Polymedco to Team up on North American Launch of Colorectal Cancer Test October 2, 2013 / GenomeWeb Daily News

ARUP Launches Blood-Based LDT for Colorectal Cancer in US Based on Epigenomics' Septin9 Biomarker July 22, 2010 / PCR Insider

Epigenomics, BioChain Collaborate to Bring Colorectal Cancer Screening Technology to China October 28, 2013 / GenomeWeb Daily News

Epigenomics' Q2 Revenues Rise Sharply; FDA Decision on Colorectal Cancer Dx Anticipated in H2 August 7, 2013 / GenomeWeb Daily News