FDA Approves First Take-Home Colon Cancer Test
For the first time, the Food and Drug Administration approved a new at-home, DNA test to screen for colon cancer.
The DNA-based stool test that was approved on Monday is called Cologuard and can detect genetic mutations in patients' stool associated with cancerous and precancerous growths in the colon. It also has a 92 percent accuracy rate, reports Philly.com.
According to the FDA, the Cologuard test, which is made by the Exact Sciences, identified more cancers during clinical trials than a rival blood test.
"Using a stool sample, Cologuard detects hemoglobin, a protein molecule that is a component of blood. Cologuard 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 with positive test results are advised to undergo a diagnostic colonoscopy," states a press release.
"This approval offers patients and physicians another option to screen for colorectal cancer," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in an agency news release.
"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 [blood] test," he added.
Health officials recommend that all Americans over age 50 get a colonoscopy at least once each decade, but many people shy away from the test. That is why doctors are hoping that Cologuard will become a game-changer.
"This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day," Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS, said in the news release.
Despite the convenience that Cologuard offers, many doctors still recommend people to get a colonoscopy because it remains the most effective method for colon cancer prevention.
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