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Epigenomics Q1 Revenues Rise 15 Percent as it Awaits FDA, CFDA Decisions

NEW YORK (GenomeWeb) – Epigenomics today reported a 15 percent year-over-year increase in its first quarter revenues as product revenues were up 32 percent.

The German-American molecular diagnostics company said that for the three months ended March 31, revenues rose to €407,000 ($559,000) from €355,000. Product revenues increased to €215,000 from €163,000.

During the quarter, a US Food and Drug Administration panel recommended regulatory approval of Epigenomics' Epi proColon colorectal cancer screening test but with concerns. The company said today that since the recommendation it has discussed with the FDA the panel's concerns, including the design of the proposed post-approval study. Epigenomics is now preparing with its US commercial partner Polymedco for the planned launch of the test in the US.

Also, Epi proColon was approved for marketing in Argentina in March, and last month Epigenomics' Chinese partner BioChain completed a clinical study validating Epi proColon in order to gain regulatory approval in China. BioChain has submitted an application with the Chinese Food and Drug Administration and Epigenomics anticipates launching the test in that country next year, it said.

Epigenomics' net loss for Q1 2014 was €2.2 million, or €.17 per share, up from a net loss of €1.7 million, or €.16 per share, a year ago.

Its R&D spending rose 18 percent year over year to €1.3 million from €1.1 million, while its SG&A costs were flat at €1.0 million.

Epigenomics ended the quarter with €7.6 million in cash and cash equivalents.

"Overall, we are very pleased with the excellent progress we made with our test in many regions of the world and strongly believe that the launches of Epi proColon will help to increase the number of people being tested early for" colorectal cancer, Epigenomics CFO and CEO Thomas Taapken said in a statement.

The company reiterated expectations that FY 2014 revenues would be "slightly" higher than 2013 revenues and maintained its guidance for a net loss of between €7.5 million and €8.5 million.