The Epi proColon (manufactured by Epigenomics) is the first and only blood-based test approved by the FDA for colorectal cancer (CRC) screening of people who are at average risk for CRC and who do not want to undergo screening with conventional (and guideline-recommended) methods with colonoscopy and/or fecal immunochemical test. This test was approved by the FDA on April 13, 2016.
This in-vitro PCR blood test is a convenient screening option for CRC, but the FDA warns it is not appropriate for people at high risk for CRC. A positive test result requires follow-up testing with colonoscopy.
“While colorectal cancer remains the second-leading cause of cancer death in the United States, 1 out of 3 eligible Americans still does not undergo colorectal cancer screening,” said Thomas Taapken, PhD, Chief Executive Officer/Chief Financial Officer of Epigenomics in a press release. “Given the significant benefits for patients, healthcare professionals and payors, Epi proColon could help to meet the objective of 80% screening compliance of the eligible US population.”
The FDA warns that the blood test is not intended to replace CRC screening by colonoscopy. Furthermore, a negative test result does not guarantee lack of cancer, and positive results have been seen in patients with diagnosed lung cancer, chronic gastritis, and in pregnant women, according to the FDA.
The test has no dietary restrictions and does not require changes in medication use.
As is the case for all new screening procedures approved by the FDA, the company will conduct a postapproval study to confirm the long-term benefits of blood-based CRC screening with the Epi proColon test.
The approval of Epi proColon was based on the results of 3 major clinical trials. The test is already available in Europe and China, among other countries.