The US Food and Drug Administration yesterday approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that might indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
Colorectal cancer, the third most commonly diagnosed cancer and second leading cause of cancer-related death, generally affects people age 50 and older. Screening for this cancer has proven effective. The CDC estimates that if everyone age 50 or older had regular screening tests as recommended, at least 60 percent of colorectal cancer deaths could be avoided.
Using a stool sample, Cologuard detects hemoglobin, a protein molecule that is a component of blood. It also detects certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Patients who receive positive test results from Cologuard are advised to undergo a diagnostic colonoscopy.
"This approval offers patients and physicians another option to screen for colorectal cancer," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. "Fecal blood testing is a well-established screening tool and the clinical data showed that the test detected more cancers than a commonly used fecal occult test."
Please note: Yesterday's approval of Cologuard doesn't affect current practice guidelines for colorectal cancer screening.
Stool DNA testing (also called "fecal DNA testing") is not a recommended method to screen for colorectal cancer by the United States Preventive Services Task Force (USPSTF). Among other guidelines, the USPSTF recommends adults age 50 to 75, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.
The Centers for Medicare & Medicaid Services (CMS) issued a proposed national coverage determination for Cologuard. CMS has proposed to cover the Cologuard test once every three years for Medicare beneficiaries who meet all of the following criteria:
- Age 50 to 85 years
- Asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test)
- Average risk of developing colorectal cancer (no personal history of adenomatous polyps, of colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or an adenomatous polyp, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).
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