New Colorectal Cancer Screening Test Approved
TUESDAY, Aug. 12, 2014 -- A screening test for colorectal cancer that can detect red blood cells and abnormal DNA in a person's stool has been approved by the U.S. Food and Drug Administration.
The noninvasive Cologuard test can be performed at home and has shown more than 90 percent accuracy in clinical trials, the agency said in a news release.
Colorectal cancer, the second-leading cause of cancer death in the United States behind lung cancer, mostly affects people aged 50 and older. About 60 percent of colorectal cancer deaths could be prevented if everyone aged 50 and older were screened, the FDA said in its news release.
From a stool sample, Cologuard detects the blood protein hemoglobin. It also identifies certain genetic DNA mutations in cells shed by advanced adenomas -- large colon polyps that develop along the walls of the large intestine and are more likely than smaller polyps to progress to colorectal cancer.
People who receive positive results should have a colonoscopy, the FDA advised.
Cologuard's approval does not change current guidelines that recommend colorectal screening using fecal occult blood testing, sigmoidoscopy or colonoscopy for all adults aged 50 to 75, the agency added.
Cologuard is produced by Exact Sciences of Madison, Wisc.
Visit the FDA to learn more.
Posted: August 2014