The U.S. Food and Drug Administration (FDA) announced on Monday that the first stool-based screening test for colorectal cancer was recently approved, providing the public a non-invasive method to detect the existence of DNA mutations and red blood cells, which may signify possible abnormal growths and may be of cancerous nature, such as precursors to cancer or colon cancer.
Cologuard, the colorectal screening manufactured by Exact Sciences, can detect possible onset of what the Centers for Disease Control and Prevention calls as the second foremost cause of mortalities related to cancer and the third most common type of cancer in the U.S.
“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,” Alberto Gutierrez, Ph.D., an Office of In Vitro Diagnostics and Radiological Health director at the Center for Devices and Radiological Health (CDRH) of the FDA, said in a statement.
Cologuard’s efficiency and safety was proven in a clinical trial screening of 10,023 subjects that compared its performance against the fecal immunochemical test or FIT, which is also a non-invasive screening commonly used to identify blood in one’s stool.
The results showed that Cologuard accurately spotted 92 percent of colorectal cancers and 42 percent of advanced adenomas more often than a FIT test. FIT screening, meanwhile, spotted 74 percent of cancers and 24 percent of advanced adenomas.
In terms of distinguishing subjects that are negative to advanced adenomas or colorectal cancer, Cologuard, however, was less accurate as compared to FIT. If FIT accurately provided negative screening test results for 95 percent of the subjects, Cologuard only provided 87 percent.
Meanwhile, the Centers for Medicare & Medicaid Services (CMS) released a nationwide coverage determination proposal for Cologuard. It is said to be the first product that went through a parallel review from the joint program of the FDA-CMS that simultaneously reviews medical devices, hence reducing the period between the device approval by the FDA and the Medicare coverage.
“Parallel review allows the last part of the FDA process to run at the same time as the CMS process, cutting as many as six months from the time from study initiation to coverage,” Nancy Stade, deputy director for policy at CDRH, said in a statement.
CMS’ chief medical officer and deputy administrator for innovation and quality, Patrick Conway, revealed in a statement that it’s a first in history that FDA approved a medical device and CMS suggested national coverage, all done on same day.
Conway added that such parallel review will, more than anything else, provide Medicare beneficiaries a timely access to a pioneering screening examination that will help detect colorectal cancer as early as possible.
Cologuard’s recent approval, however, doesn’t change the existing practice guidelines on the screening of colorectal cancer. At present, the United States Preventive Services Task Force (USPSTF) doesn’t recommend DNA testing through stool or fecal for colorectal cancer screening. Instead, it recommends that adults of 50 to 75 years of age with an average colon cancer risk be screened through fecal occult blood testing, colonoscopy or sigmoidoscopy.
