NEW YORK (GenomeWeb) – Epigenomics announced today that the US Food and Drug Administration has approved the company's blood-based colorectal cancer screening test Epi proColon.
Epi proColon is a PCR-based test that detects methylated Septin9, a biomarker already incorporated into laboratory-based tests currently available in the US. It is now approved for use in average-risk patients who choose not to undergo screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests, and will be co-marketed by Epigenomics and strategic partner Polymedco.
The FDA approval comes after a series of setbacks for Epigenomics. Although Epi proColon received a positive recommendation from an FDA advisory panel in early 2014, the agency issued Epigenomics a "not approvable letter" for the test a few months later.
In its letter to Epigenomics, the FDA noted that the firm's clinical studies of the Epi proColon were conducted in patients who had agreed to a routine screening colonoscopy, and asked for data demonstrating that the test would boost compliance to colorectal cancer screening in its intended population of patients who currently don't undergo such screening.
Meanwhile, Exact Sciences' stool-based colorectal screening test Cologuard got a nod from the advisory panel in 2014 and was approved by the FDA that August. The Centers for Medicare and Medicaid Services also issued a proposed national coverage determination for the test.
In July 2015, Epigenomics received some good news when China included the Epi proColon in its screening guidelines for colorectal cancer. However in late 2015, the FDA said it would require yet more data before making its own decision on the test. It was not until this January that the FDA told the company the additional information it had submitted was sufficient.
"We are excited by the FDA's decision to approve Epi proColon as the first and only blood-based colorectal cancer screening test," Epigenomics CEO and CFO Thomas Taapken said in a statement. "Given the significant benefits for patients, healthcare professionals, and payors, Epi proColon could help to meet the objective of 80 percent screening compliance of the eligible US population as pursued by US guideline bodies such as the American Cancer Society."
Epigenomics said that it intends to conduct a post-approval study to demonstrate the long-term benefit of the test.