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Epigenomics Plans 2012 Submission to FDA for Colon Cancer Test

NEW YORK (GenomeWeb News) – Epigenomics today released data from a clinical validation study on its colon cancer test and said that it intends to submit an application for clearance of the test in the US in 2012.

The Berlin, Germany-based molecular diagnostics firm said that the results of the study on its second-generation version of the Epi proColon test showed that the test detected 68 percent of colorectal cancer cases while correctly identifying 80 percent of patients free of disease. The company said the results were at the "lower end of the expected performance data," but would be included in a planned Premarket Approval application with the US Food and Drug Administration.

In an earlier study the test achieved 95 percent sensitivity and 85 percent specificity in a clinical study of 247 patients.

Epigenomics CEO Geert Nygaard said during a conference call this morning that the firm would need to "crunch the data" to find out the reason why there was a dip in specificity compared to previous studies of the test. "I would hate to speculate before actually having full access to the entire data set," he said.

Epigenomics plans to file the first module of the PMA this month and complete the regulatory submission next year.

In addition to the data from the validation study, Nygaard said that the firm would need to perform a head-to-head comparative study of the test with fecal immunochemical testing to demonstrate non-inferiority of Epi proColon. It expects to complete that study in 2012 and will include the results in the PMA.

The validation study included 45 cancer cases. Epigenomics said that all plasma samples were blinded, randomized, and tested with Epi proColon at three independent labs in the US.