FDA okays Epi proColon test
BERLIN & GERMANTOWN, Md.—The U.S. Food and Drug Administration (FDA) has approved Epigenomics AG’s Epi proColon test, the company reported in April. Epi proColon, an in- vitro PCR assay for the qualitative detection of Septin9 gene methylation in DNA isolated from plasma, is the first and only FDA-approved blood-based colorectal cancer screening test. This approval is based on demonstrated safety and efficacy, as well as the test’s potential to significantly improve participation rates in colorectal cancer screening. Epigenomics will conduct a post-approval study to illustrate the long-term benefit of screening with Epi proColon, per FDA requirements, and the test will be made available in the United States under a joint commercialization agreement with Polymedco, Epigenomics’ strategic partner.
“Epi proColon has the potential to become an important opportunity for laboratories across the country to join the fight on colorectal cancer,” said Polymedco’s president and CEO, Drew Cervasio. “We are very much looking forward to bringing this new, highly innovative blood-based test to the U.S. market.”