The Food and Drug Administration on Monday approved a DNA test to screen for colon cancer in people with a lower risk of developing the disease, the first such test of its kind to be cleared by U.S. regulators.
The test, called Cologuard, is used to detect genetic mutations in patients' stool associated with cancerous and precancerous growths in the colon. Doctors must prescribe the test, but patients collect stool samples at home and ship the samples to laboratories for analysis.
The FDA said the Cologuard test, made by Exact Sciences Inc., identified more cancers during clinical trials than a rival blood test.
"This approval offers patients and physicians another option to screen for colorectal cancer," Alberto Gutierrez, FDA director of in vitro diagnostics, said in a statement.
Colon cancer is the fourth most common type of tumor, and was responsible for 51,000 deaths in the U.S. last year, according to the National Cancer Institute. The disease can often be effectively treated if detected early enough, but many people avoid colonoscopy screening out of fear it will be painful and time-consuming. Minimally-invasive tests like Cologuard may help encourage more people to be tested, doctors say.
However, many doctors still recommend colonoscopy as the most effective method for colon cancer prevention. DNA-tests aren't currently recommended by the U.S. Preventive Services Task Force, an influential medical guidelines body.