FDA panel narrowly backs DNA colon cancer test
A panel of Food and Drug Administration advisers has narrowly backed an experimental blood test that uses patients' DNA to help screen for colon cancer.
The FDA's genetic experts voted 5-4, with one abstention, that the benefits of Epigenomics' test outweigh the risks. The vote amounts to a recommendation for approval of the company's Epi proColon kit. The FDA is not required to follow the panel's recommendation.
Doctors have long used stool tests to look for hidden blood that can be an early warning of cancer. Epigenomics' test is part of a new wave of diagnostics that detect genetic markers associated with cancerous tumors.
FDA scientists said in their review earlier this week that Epi proColon did not meet all of its accuracy goals in testing against older, stool-based technology.