The Food and Drug Administration (FDA) has approved a new DNA-based screening test for colon cancer which is claimed to be 90 percent accurate.
The federal body gave green signal to Exact Sciences Corp. for its home, non-invasive stool Cologuard test which is first to use DNA sequence of the patients to detect unexplained tumors which are potentially fatal in nature.
“Cologuard” was unanimously voted by the FDA panel after they concluded that its benefits outweigh the minor risks that come with it.
The test finds traces of colon cancer by spotting irregular mutations in stool samples. Those who are detected positive for this DNA-based stool test can further undergo a colonoscopy to confirm the results.
Alberto Gutierrez, Director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health, said, “Cologuard gives patients and physicians a better alternative to the painful session of colonoscopy in detecting colon cancer.”
To test the efficacy of the Cologuard test, researchers involved 10,000 patients for a study. They found that the new cancer test showed 92 percent of colon cancers and 42 percent of advanced polyps. The traditional blood screening tests comparatively spotted just 74 percent of colon cancers and 24 percent of advanced polyps.
Even if the new test comes with 90 percent accuracy claims but doctors recommend patients who are 50 years of age and above to undergo colonoscopies every 10 years to ensure whether they have colon cancer.
“Fecal blood testing is a well-established screening tool. The clinical data also showed that the test detected more cancers than a commonly used fecal occult (blood) test,” said Gutierrez.
After the FDA approval, the Cologuard test is currently under review of the US Centers for Medicare & Medicaid Services (CMS) which is carrying more in-depth trial to find out its efficacy in giving accurate results. If the new test gets CMS nod, it will be part of the health coverage of individuals between age group 50 and 85 who are at average risk of developing the colon cancer.