HealthDay News — A screening test for colorectal cancer that can detect red blood cells and abnormal DNA in a patient’s stool has been approved by the FDA.
The noninvasive Cologuard test can be performed at home and has shown more than 90% accuracy in clinical trials, the agency said in a news release.
From a stool sample, Cologuard detects hemoglobin. It also identifies certain genetic DNA mutations in cells shed by advanced adenomas. Patients who receive positive results should have a colonoscopy, advised the agency.
The safety and effectiveness of Cologuard was established in a clinical trial that involved 10,023 patients. Cologuard was compared with the performance of the fecal immunochemical test (FIT), a commonly used non-invasive screening test that detects blood in the stool.
Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas, compared with the FIT screening test, which detected 74% of cancers and 24% of advanced adenomas.
Cologuard was less accurate than FIT at correctly identifying subjects negative for colorectal cancer or advanced adenemoas. Whereas FIT provided accurate negative screening results for 95% of the study population, Cologuard correctly gave negative screening results for 87% of patients.
Cologuard’s approval does not change current guidelines that recommend colorectal screening using fecal occult blood testing, sigmoidoscopy, or colonoscopy for all patients aged 50 to 75 years.
CMS proposes to cover the Cologuard test once every three years for Medicare beneficiaries who meet all of the following criteria:
- Aged 50 to 85 years
- 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
- No personal history of adenomatous polyps, of colorectal cancer, or inflammatory bowel disease, including Crohn Disease and ulcerative colitis; no family history of colorectal cancers or an adenomatous polyp, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer