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FDA Approves Noninvasive Colorrectal Cancer Test
- Updated: August 13, 2014
Colorectal is the cancer that is third most common affecting men and women. It is also the second leading cause of deaths that are cancer related in the U.S.
The noninvasive test Cologuard can be performed in the comfort of the home, and has shown an accuracy rate of over 90% in its clinical trials, the FDA said in its news release.
From a sample of the stool, the test detects hemoglobin. It can also detect certain genetic mutations in DNA in cells shed by adenomas.
Patients who receive results that are positive should visit their medical care provider for a colonoscopy.
The effectiveness and safety of the Cologuard test was determined through a clinical trial involving more than 10,000 patients.
The Cologuard was compared to the performance of the FIT – Fecal immunochemical test, a screening test that is non-invasive and commonly used that can detect blood in the patients stool.
Cologuard was able to detect 92% of the colorectal cancers as well as 42% of the advanced adenomas. That compared to the FIT screening that detected just 74% of the cancers and 24% of the adenomas.
Cologuard however was not as accurate as FIT at identifying correctly the subjects negative for the cancer and adenomas.
Fit was able to provide accurate negative results in screening in 95% of the study participants. Cologuard correctly gave screening results that were negative in 87% of the patients.
The approval of Cologuard does not change the current guidelines that recommend screening for colorectal cancer using the fecal occult blood test method, or sigmoidoscopy or colonoscopy for patients who are 50 years or older.
Medical care providers recommend a Cologuard test once every 36 months for beneficiaries of Medicare.