FDA Issues Not Approvable Letter to Epigenomics for Colorectal Cancer Test | GenomeWeb

NEW YORK (GenomeWeb) – EpiGenomics said on Monday that it has received a "not approvable letter" from the US Food and Drug Administration for its Epi proColon screening test for colorectal cancer.

According to the Berlin, Germany-based molecular diagnostics firm, "the FDA determined that while the studies performed so far have established the clinical performance characteristics of the test, the [Premarket Approval] application does not yet contain sufficient evidence to warrant an approval for Epi proColon."

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