INDIANAPOLIS -- An Indiana University and Regenstrief Institute study of nearly 10,000 average-risk, asymptomatic men and women from 90 sites across the United States reports that a multi-target stool DNA test -- a new noninvasive colorectal cancer screening tool that has not yet been approved for sale by the Food and Drug Administration -- detects 92.3 percent of colon cancers, compared to only 73.8 percent of cancers detected by a fecal immunochemical test, the most commonly used noninvasive test today.
Study results were published online March 19 and in the April 3 print issue of the New England Journal of Medicine.
Approximately nine out of 10 Americans older than 50 are thought to be at average risk for colon cancer. Sensitivity -- the ability of a test to detect disease -- is the most important characteristic for cancer screening tests because their primary role is to "rule out" disease.
The multi-target stool DNA analysis is conducted on a single stool sample expelled from the body directly into a container and mailed to a laboratory. The new test, which looks for human DNA mutations present in the stool as well as fecal blood, identified a significantly higher number of colorectal cancers compared to the current standard noninvasive method: fecal immunochemical test, or FIT. The study found that FIT identified 73.8 percent of colon cancers, about 20 percent fewer than the new multi-target stool DNA test. Colonoscopy, which is presumed to find all colon cancers, was the "gold standard" used as the reference method in the study.
The multi-target stool DNA test's ability to identify cancer did not vary in a statistically significant way by either cancer stage or location within the colon.
"While screening has been shown to reduce both the occurrence of and death rates from colorectal cancer, not enough people get screened," said lead author Thomas F. Imperiale, M.D., of the Indiana University Scho
|Contact: Cindy Fox Aisen|