Epigenomics Gets FDA Response Letter for Epi proColon Test

The FDA has asked German diagnostics maker Epigenomics to provide evidence that its Epi proColon colorectal cancer blood test not give people a false sense of well-being and cause them to forego colonoscopies or fecal immunochemical tests — the current gold standards for colon cancer detection.

In a response to the company’s premarket approval application, submitted early last year, the FDA said the studies performed so far establish the clinical performance characteristics of the test, but do not provide sufficient evidence to warrant approval of Epi proColon.

The agency wants to see that the test is not a substitution for traditional CRC screening, but instead helps to increase screenings, said Epigenomics CEO Thomas Taapken during a Tuesday conference call. The company’s original clinical studies were performed in patients who had agreed to a routine screening colonoscopy.

Epigenomics will meet with the FDA at the end of June to discuss next steps and how to best address the outstanding questions, Taapken said. The company met with the FDA’s Medical Device Advisory Committee on March 26, and while the committee said the test’s “benefits outweigh its risks,” a “small and doable” study is still needed for U.S. approval, he added.

The study will be similar to Epigenomics’ 2012 Berlin Adherence Study, in which 178 average aged patients were asked to participate in a CRC colonoscopy. Only 38 percent agreed, but 80 percent of those who refused agreed to take a FIT or Epi proColon blood test.

The FDA wants patients who test positive for CRC via FIT or blood-based testing to then have a colonoscopy, Taapken said. The agency also wants data on how many patients initially say yes to a colonoscopy and how many say yes later to confirm their status. — Kellen Owings

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