-- Scott Roberts
TUESDAY, Aug. 12, 2014 (HealthDay News) -- 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
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
Cologuard is produced by Exact Sciences of Madison, Wisc.
FDAto learn more.
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