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Epigenomics Q2 Revenues Rise 18 Percent; CEO Says FDA Approval of its Colorectal Screening Test 'Very Likely'

NEW YORK (GenomeWeb) – Epigenomics today said that its second quarter revenues rose 18 percent year over year.

The company's revenues for the three months ended June 30 reached €405,000 ($541,000), compared to €343,000 in Q2 2013.

During the quarter, the US Food and Drug Administration issued a "not approvable letter" to the German molecular diagnostics firm for its Epi proColon screening test for colorectal cancer. In March, an FDA panel voted in favor of the test, though with concerns about the lack of long-term data around the programmatic use of the test.

The company is currently trying to address the panel's concerns, and in a statement today, Epigenomics CEO/CFO Thomas Taapken said that while the FDA's decision was "unexpected, we are now more than ever convinced that finally the approval of our patient-friendly blood-based test for [colorectal cancer] screening is very likely, and that it is ultimately a matter of time to complete the additional data requested by the FDA."

He added that its US commercialization partner, Polymedco, "remains fully committed to begin commercialization once our product is approved, and we are well underway in gearing up manufacturing capabilities in order to be able to supply the demand once the product will be on the market."

On Monday, though, a potential competitor, Exact Sciences, took the lead on the regulatory and reimbursement front when the FDA approved that firm's colorectal cancer screening test Cologuard, and the Centers for Medicare and Medicaid Services issued a proposed national coverage determination for the test.

In addition to seeking FDA approval, Epigenomics awaits a decision by Chinese regulators on Epi proColon. Its partner in China, BioChain, submitted an application with the Chinese Food and Drug Administration in Q2 for approval of the test in that country.

Epigenomics' net loss for Q2 2014 was €1.8 million, or €.13 per share, compared to a net loss of €1.6 million, or €.14 per share, in the year-ago period. The company used 13.5 million shares to calculate its loss on a per-share basis for the recently completed quarter and 12 million shares for Q2 2013.

The company cut its R&D spending 13 percent year over year to €885,000 from €1 million. Its SG&A costs were up 8 percent to €983,000 from €912,000.

Epigenomics ended the quarter with €5.9 million in cash and cash equivalents.