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FDA Issues Not Approvable Letter to Epigenomics for Colorectal Cancer Test

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."

Specifically, Epigenomics said that the FDA is seeking additional data demonstrating that the test will increase compliance to colorectal cancer screening in its intended use population, which are those patients who currently don't undergo CRC screening by guideline-recommended methods, such as colonoscopy or fecal immunochemical testing. "Since Epigenomics' originally conducted clinical studies were performed in patients who had agreed to a routine screening colonoscopy, the FDA is requesting Epigenomics to demonstrate whether patients in the targeted population can be turned compliant to CRC screening by Epi proColon," the firm said in a statement.

It said that it would meet with the FDA at the end of this month to discuss the next steps and how best to address the agency's concerns. The company expects it will need to conduct an additional study to address the agency's concerns.

"We were surprised with FDA's assessment of our PMA submission," Thomas Taapken, CEO/CFO of Epigenomics, said. "While this is not what we expected, we remain fully committed to offering people who are unwilling or unable to undergo recommended CRC screening a highly efficient and convenient alternative for CRC screening."

In March an FDA advisory committee voted in favor of approving Epigenomics' test, but members also voiced concerns. Specifically, the panel raised questions about a lack of long-term data around the programmatic use of the test.

The same panel gave a favorable review that week for Exact Sciences Cologuard test, a stool-based, non-invasive molecular screening test for colorectal cancer. Exact Sciences has yet to receive a decision from the FDA, but one of the advisory committee members said in March that Cologuard was "one of the biggest improvements to early [CRC] detection" he had seen.

Epigenomics' Epi proColon test is based on the Septin9 biomarker, which has been incorporated into laboratory-based tests currently available in the US. In addition, the test, which uses real-time PCR in detecting methylated Septin9, has been approved for marketing in Europe since 2012.